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[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Melasma ( or chloasma ) is a common disorder of cutaneous hyperpigmentation predominantly affecting sun-exposed areas in women . The pathogenesis of melasma is not fully understood and treatments are frequently disappointing and often associated with side effects . Pycnogenol is a st and ardized extract of the bark of the French maritime pine ( Pinus pinaster ) , a well-known , potent antioxidant . Studies in vitro show that Pycnogenol is several times more powerful than vitamin E and vitamin C. In addition , it recycles vitamin C , regenerates vitamin E and increases the endogenous antioxidant enzyme system . Pycnogenol protects against ultraviolet ( UV ) radiation . Therefore its efficacy in the treatment of melasma was investigated . Thirty women with melasma completed a 30-day clinical trial in which they took one 25 mg tablet of Pycnogenol with meals three times daily , i.e. 75 mg Pycnogenol per day . These patients were evaluated clinical ly by parameters such as the melasma area index , pigmentary intensity index and by routine blood and urine tests . After a 30-day treatment , the average melasma area of the patients decreased by 25.86 + /- 20.39 mm(2 ) ( p < 0.001 ) and the average pigmentary intensity decreased by 0.47 + /- 0.51 unit ( p < 0.001 ) . The general effective rate was 80 % . No side effect was observed . The results of the blood and urine test parameters at baseline and at day 30 were within the normal range . Moreover , several other associated symptoms such as fatigue , constipation , pains in the body and anxiety were also improved . To conclude , Pycnogenol was shown to be therapeutically effective and safe in patients suffering from melasma The objective of the present study was to assess the toxicology of melatonin ( 10 mg ) , administered for 28 days to 40 volunteers r and omly assigned to groups receiving either melatonin ( N = 30 ) or placebo ( N = 10 ) in a double-blind fashion . The following measurements were performed : polysomnography ( PSG ) , laboratory examinations , including complete blood count , urinalysis , sodium , potassium and calcium levels , total protein levels , albumin , blood glucose , triglycerides , total cholesterol , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and very low-density lipoprotein ( VLDL ) , urea , creatinine , uric acid , glutamic-oxalacetic transaminase ( GOT ) , glutamic-pyruvate transaminase ( GPT ) , bilirubin , alkaline phosphatase , gama-glutamic transaminase ( GGT ) , T3 , T4 , TSH , LH/FSH , cortisol , and melatonin serum concentrations . In addition , the Epworth Somnolence Scale ( ESS ) and a sleep diary ( SD ) were also applied to the volunteers 1 wk before each PSG . In addition , the volunteers were asked about possible side effects ( SE ) that appeared during the treatment . The study was carried out according to the following timetable : Visit 0 , filling out the term of consent and inclusion criteria ; Visit 1 , PSG , laboratory examinations , ESS , SD , melatonin serum concentrations ; Visit 2 , SD , melatonin serum concentrations , SE ; Visit 3 , melatonin serum concentrations , PSG , ESS , SE ; Visit 4 , laboratory examinations , SE , melatonin serum concentrations , SD ; and Visit 5 , PSG , ESS , SE . Analysis of the PSG showed a statistically significant reduction of stage 1 of sleep in the melatonin group . No other differences between the placebo and melatonin groups were obtained . In the present study we did not observe , according to the parameters analyzed , any toxicological effect that might compromise the use of melatonin at a dose of 10 mg for the period of time utilized in this study BACKGROUND Glutathione ( GSH ) is a naturally occurring thiol that has been reported to cause skin lightening in a manner for which several mechanisms have been proposed . Highest plasma concentrations are achieved with IV administration but are accompanied by greater levels of risk . Oral administration has been less successful in elevating plasma GSH levels . OBJECTIVES The use of a lozenge containing GSH was investigated in order to evaluate the buccal mucosa as a route for GSH administration . Substances that are absorbed through the buccal route go directly into the systemic circulation , effectively bypassing the gastrointestinal tract . METHODS Thirty Filipino females with Fitzpatrick skin types IV or V received a glutathione-containing lozenge daily for eight weeks . RESULTS Findings showed a significant decrease in melanin indices from baseline to endpoint that became evident in as little as two weeks . There were no serious adverse events , and laboratory examination findings remained normal . CONCLUSIONS The authors conclude that the lozenge containing glutathione was safe and effective in lightening the skin of Filipino women BACKGROUND UV radiation induces damage to human skin . Protection of skin by an oral photoprotective agent would have substantial benefits . Objective We investigated the photoprotective effect of oral administration of an extract of the natural antioxidant Polypodium leucotomos ( PL ) . METHODS A total of 9 healthy participants of skin types II to III were exposed to varying doses of artificial UV radiation without and after oral administration of PL ( 7.5 mg/kg ) . At 24 hours after exposure the erythema reaction was assessed and paired biopsy specimens were obtained from PL-treated and untreated skin . RESULTS A significant decrease in erythema was found in PL-treated skin ( P < .01 ) . Histologically , PL-treated biopsy specimens showed less sunburn cells ( P < .05 ) , cyclobutane pyrimidine dimers ( P < .001 ) , proliferating epidermal cells ( P < .001 ) , and dermal mast cell infiltration ( P < .05 ) . A trend toward Langerhans cell preservation was seen . CONCLUSION Oral administration of PL is an effective systemic chemophotoprotective agent leading to significant protection of skin against UV radiation BACKGROUND Melasma is associated with epidermal hyperpigmentation , weak basement membrane , vascular proliferation and increased numbers of mast cell . Tranexamic acid ( TXA ) , a plasmin inhibitor , is reported to improve melasma when injected locally . However , the effects of oral and topical TXA on melasma have not been well studied and the underlying mechanism remains unclear . OBJECTIVES To eluci date the effects of oral and topical TXA on melasma . METHODS A clinical study was conducted with 25 women for 8 weeks from March to July 2010 . Volunteers were instructed to take two TXA tablets three times a day and apply a TXA topical agent twice a day for 8 weeks . Skin pigmentation and erythema was measured using a Mexameter ( ® ) during each visit and skin biopsies were collected from eight subjects before and 8 weeks after treatment . Fontana-Masson , anti-CD31 , antitryptase and antitype IV collagen staining was performed . RESULTS Twenty-two subjects completed the study and no serious adverse events occurred during the study period . The mean lesional melanin index ( MI ) scores decreased significantly . Interestingly , the MI scores for the perilesional skin increased . The erythema index scores of lesional and perilesional skin also showed a similar pattern . Histological analysis showed significant reduction of epidermal pigmentation , vessel numbers and mast cell counts . Type IV collagen staining was not observed in all specimens . CONCLUSION TXA decreased epidermal pigmentation associated with melasma and also reversed melasma-related dermal changes , such as vessel number and increased numbers of mast cells Abstract Objective : To determine whether orally administered glutathione , 500 mg per day for 4 weeks , affects the skin melanin index , when compared with placebo . Methods : This r and omized , double-blind , two-arm , placebo-controlled study was set in the King Chulalongkorn Memorial Hospital , Bangkok , Thail and , a teaching hospital affiliated with a medical school . Sixty otherwise healthy medical students were r and omized to receive either glutathione capsules , 500 mg/day in two divided doses , or placebo for 4 weeks . The main outcome was mean reduction of melanin indices measured at six different sites . Several secondary outcomes , including UV spots , were recorded by VISIA ™ . Efficacies of glutathione and placebo were compared by ANCOVA with baseline values as co-variates . Results : Sixty participants enrolled and completed the study . At 4 weeks , the melanin indices decreased consistently at all six sites in subjects who received glutathione . The reductions were statistically significantly greater than those receiving placebo at two sites , namely the right side of the face and the sun-exposed left forearm ( p-values = 0.021 and 0.036 , respectively ) . This was similarly reflected in the changes in the number of UV spots , as measured by VISIA . Both glutathione and placebo were very well tolerated . Conclusion : Oral glutathione administration results in a lightening of skin color in a small number of subjects . However , long-term safety has not been established and warrants more extensive clinical trials BACKGROUND Melasma is a common , acquired , symmetric hypermelanosis characterized by irregular brown to gray-brown macules on the cheeks , forehead , nasal bridge , cutaneous part of the upper lip , m and ible , and the upper arms . Few trials have been conducted regarding the potential benefits of oral procyanidin in melasma . AIM To assess the safety and efficacy of oral procyanidin + vitamins A , C , E among Filipino patients with epidermal melasma . METHODS A r and omized , double-blind , placebo-controlled trial lasting 8 weeks , involving 60 adult female volunteers with bilateral epidermal melasma , Fitzpatrick skin types III-V , was conducted at the Section of Dermatology , Research Institute for Tropical Medicine , Department of Health , Manila , Philippines . Patients received either the test drug or placebo , twice daily with meals . Changes in pigmentation were measured using a mexameter , the melasma area and severity index ( MASI ) , and a global evaluation by the patient and investigator . Safety evaluations were performed at each follow-up visit . RESULTS Fifty-six patients completed the trial . Mexameter results demonstrated a significant decrease in the degree of pigmentation in the left malar ( 165.85 + /- 70.909 ) and right malar ( 161.33 + /- 61.824 ) regions ( P < 0.0001 ) . MASI scores showed a significant improvement in the left malar ( 2.4862 + /- 1.67816 ) and right malar ( 1.8889 + /- 1.67110 ) regions ( P = 0.001 ) . Procyanidin + vitamins A , C , E proved to be safe and well tolerated , with minimal adverse events . CONCLUSIONS In this 8-week trial period , oral procyanidin + vitamins A , C , E proved to be safe and effective among Filipino women with epidermal melasma Background : Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy . Tranexamic acid , a plasmin inhibitor , has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results . Objectives : To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients . Material s and Methods : 40 patients of melasma of either sex attending to dermatology OPD were enrolled in this study . Participants were r and omly divided into two groups with 20 patients in each group . Group A patients were asked to apply the cream only and Group B patients received oral tranexamic acid 250 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01 % , tretinoin 0.05 % , and hydroquinone 2 % once daily for 8 weeks . Response was evaluated using melasma area severity index ( MASI ) at baseline , 4 weeks , and 8 weeks . Results : 40 patients completed the study . The MASI scores at baseline , 4 weeks and 8 weeks in group A were 15.425 + 1.09 , 11.075 + 9.167 and 6.995 + 6.056 respectively and in group B 18.243 + 1.05 , 6.135 + 4.94 and 2.19 + 3.38 . Intergroup comparison showed a faster reduction in pigmentation in Group B as compared to Group A and the results were statistically significant at 4 weeks ( P value 0.014 ) and 8 weeks ( P value 0.000 ) . The efficacy was maintained throughout the 6-month follow-up period . Conclusion : Addition of oral tranexamic acid to fluocinolone-based triple combination cream results in a faster and sustained improvement in the treatment of melasma OBJECTIVE The objective of this study was to determine the safety of oral Polypodium leucotomos extract administered twice daily to healthy adults for 60 days and assess its ability to provide protection against exposure to ultraviolet radiation . DESIGN This was a r and omized , double-blind , placebo- \n Output:\n " }, { "from": "agent", "value": "These agents appear to have a beneficial effect on melasma improvement .\nIn conclusion , oral medications have a role in melasma treatment and have been shown to be efficacious and tolerable with a minimal number and severity of adverse events ." } ]
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: Melasma ( or chloasma ) is a common disorder of cutaneous hyperpigmentation predominantly affecting sun-exposed areas in women . The pathogenesis of melasma is not fully understood and treatments are frequently disappointing and often associated with side effects . Pycnogenol is a st and ardized extract of the bark of the French maritime pine ( Pinus pinaster ) , a well-known , potent antioxidant . Studies in vitro show that Pycnogenol is several times more powerful than vitamin E and vitamin C. In addition , it recycles vitamin C , regenerates vitamin E and increases the endogenous antioxidant enzyme system . Pycnogenol protects against ultraviolet ( UV ) radiation . Therefore its efficacy in the treatment of melasma was investigated . Thirty women with melasma completed a 30-day clinical trial in which they took one 25 mg tablet of Pycnogenol with meals three times daily , i.e. 75 mg Pycnogenol per day . These patients were evaluated clinical ly by parameters such as the melasma area index , pigmentary intensity index and by routine blood and urine tests . After a 30-day treatment , the average melasma area of the patients decreased by 25.86 + /- 20.39 mm(2 ) ( p < 0.001 ) and the average pigmentary intensity decreased by 0.47 + /- 0.51 unit ( p < 0.001 ) . The general effective rate was 80 % . No side effect was observed . The results of the blood and urine test parameters at baseline and at day 30 were within the normal range . Moreover , several other associated symptoms such as fatigue , constipation , pains in the body and anxiety were also improved . To conclude , Pycnogenol was shown to be therapeutically effective and safe in patients suffering from melasma The objective of the present study was to assess the toxicology of melatonin ( 10 mg ) , administered for 28 days to 40 volunteers r and omly assigned to groups receiving either melatonin ( N = 30 ) or placebo ( N = 10 ) in a double-blind fashion . The following measurements were performed : polysomnography ( PSG ) , laboratory examinations , including complete blood count , urinalysis , sodium , potassium and calcium levels , total protein levels , albumin , blood glucose , triglycerides , total cholesterol , high-density lipoprotein ( HDL ) , low-density lipoprotein ( LDL ) , and very low-density lipoprotein ( VLDL ) , urea , creatinine , uric acid , glutamic-oxalacetic transaminase ( GOT ) , glutamic-pyruvate transaminase ( GPT ) , bilirubin , alkaline phosphatase , gama-glutamic transaminase ( GGT ) , T3 , T4 , TSH , LH/FSH , cortisol , and melatonin serum concentrations . In addition , the Epworth Somnolence Scale ( ESS ) and a sleep diary ( SD ) were also applied to the volunteers 1 wk before each PSG . In addition , the volunteers were asked about possible side effects ( SE ) that appeared during the treatment . The study was carried out according to the following timetable : Visit 0 , filling out the term of consent and inclusion criteria ; Visit 1 , PSG , laboratory examinations , ESS , SD , melatonin serum concentrations ; Visit 2 , SD , melatonin serum concentrations , SE ; Visit 3 , melatonin serum concentrations , PSG , ESS , SE ; Visit 4 , laboratory examinations , SE , melatonin serum concentrations , SD ; and Visit 5 , PSG , ESS , SE . Analysis of the PSG showed a statistically significant reduction of stage 1 of sleep in the melatonin group . No other differences between the placebo and melatonin groups were obtained . In the present study we did not observe , according to the parameters analyzed , any toxicological effect that might compromise the use of melatonin at a dose of 10 mg for the period of time utilized in this study BACKGROUND Glutathione ( GSH ) is a naturally occurring thiol that has been reported to cause skin lightening in a manner for which several mechanisms have been proposed . Highest plasma concentrations are achieved with IV administration but are accompanied by greater levels of risk . Oral administration has been less successful in elevating plasma GSH levels . OBJECTIVES The use of a lozenge containing GSH was investigated in order to evaluate the buccal mucosa as a route for GSH administration . Substances that are absorbed through the buccal route go directly into the systemic circulation , effectively bypassing the gastrointestinal tract . METHODS Thirty Filipino females with Fitzpatrick skin types IV or V received a glutathione-containing lozenge daily for eight weeks . RESULTS Findings showed a significant decrease in melanin indices from baseline to endpoint that became evident in as little as two weeks . There were no serious adverse events , and laboratory examination findings remained normal . CONCLUSIONS The authors conclude that the lozenge containing glutathione was safe and effective in lightening the skin of Filipino women BACKGROUND UV radiation induces damage to human skin . Protection of skin by an oral photoprotective agent would have substantial benefits . Objective We investigated the photoprotective effect of oral administration of an extract of the natural antioxidant Polypodium leucotomos ( PL ) . METHODS A total of 9 healthy participants of skin types II to III were exposed to varying doses of artificial UV radiation without and after oral administration of PL ( 7.5 mg/kg ) . At 24 hours after exposure the erythema reaction was assessed and paired biopsy specimens were obtained from PL-treated and untreated skin . RESULTS A significant decrease in erythema was found in PL-treated skin ( P < .01 ) . Histologically , PL-treated biopsy specimens showed less sunburn cells ( P < .05 ) , cyclobutane pyrimidine dimers ( P < .001 ) , proliferating epidermal cells ( P < .001 ) , and dermal mast cell infiltration ( P < .05 ) . A trend toward Langerhans cell preservation was seen . CONCLUSION Oral administration of PL is an effective systemic chemophotoprotective agent leading to significant protection of skin against UV radiation BACKGROUND Melasma is associated with epidermal hyperpigmentation , weak basement membrane , vascular proliferation and increased numbers of mast cell . Tranexamic acid ( TXA ) , a plasmin inhibitor , is reported to improve melasma when injected locally . However , the effects of oral and topical TXA on melasma have not been well studied and the underlying mechanism remains unclear . OBJECTIVES To eluci date the effects of oral and topical TXA on melasma . METHODS A clinical study was conducted with 25 women for 8 weeks from March to July 2010 . Volunteers were instructed to take two TXA tablets three times a day and apply a TXA topical agent twice a day for 8 weeks . Skin pigmentation and erythema was measured using a Mexameter ( ® ) during each visit and skin biopsies were collected from eight subjects before and 8 weeks after treatment . Fontana-Masson , anti-CD31 , antitryptase and antitype IV collagen staining was performed . RESULTS Twenty-two subjects completed the study and no serious adverse events occurred during the study period . The mean lesional melanin index ( MI ) scores decreased significantly . Interestingly , the MI scores for the perilesional skin increased . The erythema index scores of lesional and perilesional skin also showed a similar pattern . Histological analysis showed significant reduction of epidermal pigmentation , vessel numbers and mast cell counts . Type IV collagen staining was not observed in all specimens . CONCLUSION TXA decreased epidermal pigmentation associated with melasma and also reversed melasma-related dermal changes , such as vessel number and increased numbers of mast cells Abstract Objective : To determine whether orally administered glutathione , 500 mg per day for 4 weeks , affects the skin melanin index , when compared with placebo . Methods : This r and omized , double-blind , two-arm , placebo-controlled study was set in the King Chulalongkorn Memorial Hospital , Bangkok , Thail and , a teaching hospital affiliated with a medical school . Sixty otherwise healthy medical students were r and omized to receive either glutathione capsules , 500 mg/day in two divided doses , or placebo for 4 weeks . The main outcome was mean reduction of melanin indices measured at six different sites . Several secondary outcomes , including UV spots , were recorded by VISIA ™ . Efficacies of glutathione and placebo were compared by ANCOVA with baseline values as co-variates . Results : Sixty participants enrolled and completed the study . At 4 weeks , the melanin indices decreased consistently at all six sites in subjects who received glutathione . The reductions were statistically significantly greater than those receiving placebo at two sites , namely the right side of the face and the sun-exposed left forearm ( p-values = 0.021 and 0.036 , respectively ) . This was similarly reflected in the changes in the number of UV spots , as measured by VISIA . Both glutathione and placebo were very well tolerated . Conclusion : Oral glutathione administration results in a lightening of skin color in a small number of subjects . However , long-term safety has not been established and warrants more extensive clinical trials BACKGROUND Melasma is a common , acquired , symmetric hypermelanosis characterized by irregular brown to gray-brown macules on the cheeks , forehead , nasal bridge , cutaneous part of the upper lip , m and ible , and the upper arms . Few trials have been conducted regarding the potential benefits of oral procyanidin in melasma . AIM To assess the safety and efficacy of oral procyanidin + vitamins A , C , E among Filipino patients with epidermal melasma . METHODS A r and omized , double-blind , placebo-controlled trial lasting 8 weeks , involving 60 adult female volunteers with bilateral epidermal melasma , Fitzpatrick skin types III-V , was conducted at the Section of Dermatology , Research Institute for Tropical Medicine , Department of Health , Manila , Philippines . Patients received either the test drug or placebo , twice daily with meals . Changes in pigmentation were measured using a mexameter , the melasma area and severity index ( MASI ) , and a global evaluation by the patient and investigator . Safety evaluations were performed at each follow-up visit . RESULTS Fifty-six patients completed the trial . Mexameter results demonstrated a significant decrease in the degree of pigmentation in the left malar ( 165.85 + /- 70.909 ) and right malar ( 161.33 + /- 61.824 ) regions ( P < 0.0001 ) . MASI scores showed a significant improvement in the left malar ( 2.4862 + /- 1.67816 ) and right malar ( 1.8889 + /- 1.67110 ) regions ( P = 0.001 ) . Procyanidin + vitamins A , C , E proved to be safe and well tolerated , with minimal adverse events . CONCLUSIONS In this 8-week trial period , oral procyanidin + vitamins A , C , E proved to be safe and effective among Filipino women with epidermal melasma Background : Melasma is a common acquired cause of facial hyperpigmentation with no definitive therapy . Tranexamic acid , a plasmin inhibitor , has demonstrated depigmenting properties and combining this oral drug with other modalities of treatment has shown promising results . Objectives : To compare the efficacy of a combination of oral tranexamic acid and fluocinolone-based triple combination cream with that of fluocinolone-based triple combination cream alone in melasma among Indian patients . Material s and Methods : 40 patients of melasma of either sex attending to dermatology OPD were enrolled in this study . Participants were r and omly divided into two groups with 20 patients in each group . Group A patients were asked to apply the cream only and Group B patients received oral tranexamic acid 250 mg twice daily and applied a triple combination cream containing fluocinolone acetonide 0.01 % , tretinoin 0.05 % , and hydroquinone 2 % once daily for 8 weeks . Response was evaluated using melasma area severity index ( MASI ) at baseline , 4 weeks , and 8 weeks . Results : 40 patients completed the study . The MASI scores at baseline , 4 weeks and 8 weeks in group A were 15.425 + 1.09 , 11.075 + 9.167 and 6.995 + 6.056 respectively and in group B 18.243 + 1.05 , 6.135 + 4.94 and 2.19 + 3.38 . Intergroup comparison showed a faster reduction in pigmentation in Group B as compared to Group A and the results were statistically significant at 4 weeks ( P value 0.014 ) and 8 weeks ( P value 0.000 ) . The efficacy was maintained throughout the 6-month follow-up period . Conclusion : Addition of oral tranexamic acid to fluocinolone-based triple combination cream results in a faster and sustained improvement in the treatment of melasma OBJECTIVE The objective of this study was to determine the safety of oral Polypodium leucotomos extract administered twice daily to healthy adults for 60 days and assess its ability to provide protection against exposure to ultraviolet radiation . DESIGN This was a r and omized , double-blind , placebo- Output:
MS2828
[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Post-thrombotic syndrome varies from mild oedema to incapacitating swelling with pain and ulceration . We investigated the rate of post-thrombotic syndrome after a first episode of deep-vein thrombosis and assessed the preventive effect of direct application of a sized-to-fit grade d compression stocking . METHODS Patients with a first episode of venogram-proven proximal deep-vein thrombosis were r and omly assigned no stockings ( the control group ) or made-to-measure grade d compression elastic stockings for at least 2 years . Post-thrombotic syndrome was assessed with a st and ard scoring system that combined clinical characteristics and objective leg measurements . Patients were assessed every 3 months during the first 2 years , and every 6 months thereafter for at least 5 years . The cumulative incidence of mild-to-moderate post-thrombotic syndrome was the primary outcome measure . FINDINGS Of the 315 consecutive out patients considered for inclusion , 44 were excluded and 77 did not consent to take part . 194 patients were r and omly assigned compression stockings ( n = 96 ) or no stockings ( n = 98 ) . The median follow-up was 76 months ( range 60 - 96 ) in both groups . Mild-to-moderate post-thrombotic syndrome ( score > or = 3 plus one clinical sign ) occurred in 19 ( 20 % ) patients in the stocking group and in 46 ( 47 % ) control-group patients ( p < 0.001 ) . 11 ( 11 % ) patients in the stocking group developed severe post-thrombotic syndrome ( score > or = 4 ) , compared with 23 ( 23 % ) patients in the control group ( p < 0.001 ) . In both groups , most cases of post-thrombotic syndrome occurred within 24 months of the acute thrombotic event . INTERPRETATION About 60 % of patients with a first episode of proximal deep-vein thrombosis develop post-thrombotic syndrome within 2 years . A sized-to-fit compression stocking reduced this rate by about 50 % Fibrinolytic treatment of acute deep vein thrombosis ( DVT ) of the leg with high-dose streptokinase ( SK ) ( 100,000 U/h ) in 39 cases , or low-dose SK ( approx 10,000 U/h ) in combination with low-dose heparin in 41 cases , was studied in a prospect i ve r and omized trial . The degree of thrombolysis was similar in both groups and did not correlate with age or size of the thrombus or with fibrinogen level . The degree of late recanalization was also similar in both groups . There were however significantly more patients with postthrombotic changes in the low-dose group than in the high-dose group after a mean follow-up time of 31 and 38 months respectively . In the low-dose group 2 intracranial hemorrhages occurred ( one was fatal ) and one patient died of pulmonary embolism , but there were significantly less allergic side effects to SK . There were no cases of such serious side effects in the highdose group . Although low-dose SK has equal thrombolytic effect it seems inferior to high-dose SK , since it probably causes more severe hemorrhagic side-effects In a prospect i ve study , 174 patients ( 118 women and 56 men , average age 44 years , range 14 to 82 ) with proximal extensive thrombosis received streptokinase ( 100,000 U/hour ) for an average of 2.8 days ( range 0.5 to 7 ) through the catheter of a temporary caval filter . Twenty-seven of 45 ( 60 % ) patients with nonocclusive clots were completely free of clots at the second phlebography versus 17 of 116 ( 14 % ) with occlusive clots ( p less than 0.001 ) . Among nonocclusive clots , proximal ones ( caval , iliac and femoral ) were more easily lysed than popliteal clots ( 88 of 116 [ 76 % ] vs 26 of 58 [ 45 % ] ; p less than 0.001 ) . In 41 of 132 ( 31 % ) patients , a daily injection of contrast medium through the filter-carrying catheter enabled the observation of a clot in the filter , which was lysed by streptokinase . Seventy patients with follow-up greater than 2 years ( median 34 months ) were examined clinical ly . Nineteen of 22 ( 86 % ) patients with venograms free of clots at discharge were free of clinical sequelae versus 16 of 48 ( 33 % ) without normal venograms ( p less than 0.001 ) . It is concluded that : ( 1 ) in the case of occlusive clots , only a few patients were normalized after streptokinase ; ( 2 ) proximal nonocclusive clots were most effectively lysed ; ( 3 ) when venograms were free of clots at discharge , the majority of patients did not have venous sequelae at follow-up ; and ( 4 ) embolic migration seems to occur frequently with streptokinase Twenty patients with clinical signs of deep vein thrombosis of a duration not exceeding 72 hours , and with the condition confirmed phlebographically , were r and omly allocated to one of two groups in a double-blind study . In group 1 the patients received urokinase in a low-dose regimen of 200 000 Ploug units during the first 24 hours , followed by infusion of heparin , 40 000 units daily during the next 5 days . Patients in group 2 received heparin only , 40 000 units daily for 6 days . The clinical course was assessed daily . When the infusion period was completed , the phlebography was repeated , and the results of the two examinations were compared with respect to extent of filling defects and the degree of non-filling of the deep veins . We found no superiority in the regimen consisting of urokinase preceding heparin infusion , compared with that of heparin infusion alone . Most of the patients improved clinical ly during the 6-day infusion period , but the degree of thrombosis , evaluated phlebographically , was unaltered or even deteriorated during the period in all patients except two . Overt bleeding was noted in 6 patients Nineteen cases were reinvestigated 8 - 14 years after treatment with SK or heparin . Judging from personal interviews , foot volumometry and phlebography , treatment with SK appears to be more preferable since it was less often followed by late severe postthrombotic changes In a prospect i ve study all positive phlebographies within the well-defined population of the city of Malmö , Sweden , during 1987 were studied in order to determine the incidence of deep venous thrombosis ( DVT ) . Epidemiological data were analysed for the detection of patient groups at increased risk of DVT . The incidence was found to be equal for both sexes , i.e. 1.6 per 1000 inhabitants a year . Risk factors were found to be in accordance with earlier studies . The median age for men was 66 years , compared to 72 years for women . At diagnosis of DVT , 19 % of subjects had a known malignancy and within 1 year 5 % ( 19 cases ) developed a new malignancy . Of the men , 29 % had postoperative or post-traumatic ( fracture ) DVT , compared to 46 % of the women . Fewer patients with DVT than expected ( 39 % ) belonged to blood group 0 ( 31 % ) ( P less than 0.005 ) . Pulmonary embolism ( PE ) was clinical ly suspected in only 5 % of cases , and diagnosis was verified scintigraphically in 2 % of cases . None of these died of PE , but of 6 patients who were found to have PE at autopsy , four died about 4 weeks after the DVT was diagnosed In a prospect i ve and r and omized multicenter trial the efficacy of intermittent regional and systemic thrombolytic therapy for DVT was evaluated . 137 patients with phlebographically confirmed acute DVT above the calf region were treated with 20 mg of rt-PA for 4 h each day . Thrombolysis was applied either locally via a dorsal pedal vein of the firmly b and aged affected leg or systemically using a cubital vein . Treatment lasted for 4 - 7 days , and during this time unfractionated heparin was applied continuously with the dosage adjusted according to aPTT ( 1.5 - 2.0 times the normal value ) . A second phlebography was performed within 24 h after the end of treatment . Results were evaluated by an independent radiologist who was unaware of the treatment given . Significant thrombolytic results ( e.g. lysis of more than 50 % of the original thrombus and complete recanalization of all affected veins ) were reached in only 1/3 of all patients . Rates of recanalization did not differ in both groups and bleeding complications occurred in 26.5 % . We conclude that intermittent local or systemic application of 20 mg rt-PA seems to be ineffective in the treatment of DVT Bolus urokinase ( Abbokinase ) is effective for initial treatment of deep venous thrombosis but is associated with a high rate of rigors . This r and omized controlled trial was undertaken among patients with deep venous thrombosis to evaluate the efficacy and safety of a novel thrombolytic agent , recombinant urokinase ( rUK ) , administered as three bolus infusions of 1 million U over a 24-hour period versus heparin alone . Of 361 patients with DVT screened , 17 ( 5 % ) were enrolled . Recent surgery was the most common reason for exclusion ( n = 113 , 31 % ) . Images of the patients were obtained at baseline , 24 to 48 hours after r and omization , and before hospital discharge . Two patients in each treatment group had minor clot progression . One patient in the heparin group had no change ; all other patients showed mild ( < 50 % ; n = 5 in each group ) or moderate ( > 50 % ; n = 1 in each group ) improvement . No bleeding complications or rigors developed in patients r and omized to rUK . Mean bleeding times among patients given rUK were not significantly different from mean values of patients given heparin at any of the measured time points available for comparison ( 331 vs 387 seconds at baseline and 381 vs 416 seconds at 24 hours ) . However , mean fibrinogen levels declined with successive urokinase boluses and were significantly lower than levels in patients treated with heparin at 24 ( 233 mg/dl vs 466 mg/dl , p = 0.01 ) and 48 hours ( 270 mg/dl vs 474 mg/dl , p = 0.02 ) . Although bolus rUK had a favorable safety profile , rUK was no more effective than heparin in achieving clot lysis at the doses used in this trial A controlled , prospect i ve study comparing streptokinase and heparin treatment has been completed in 51 patients presenting with acute proximal venous thrombosis of less than 8 days ' clinical duration . Patients were studied by means of pre‐treatment , post‐treatment , 3‐ and 12‐monthly phlebography and pulmonary perfusion scanning and were followed up at 3‐monthly intervals PURPOSE To compare the efficacy and safety of recombinant human tissue-type plasminogen activator ( rt-PA , supplied as Activase ) with heparin alone or rt-PA plus heparin in the treatment of venographically documented proximal deep venous thrombosis ( DVT ) of the leg . PATIENTS AND METHODS Sixty-four patients underwent 65 r and omizations to rt-PA alone ( n = 36 ) , rt-PA plus heparin ( n = 17 ) , or heparin alone ( n = 12 ) in a prospect i ve , multicenter , r and omized , open-label trial , with efficacy assessed by a radiology panel unaware of treatment assignment . Patients r and omly assigned to rt-PA received 0.05 mg/kg/hour for 24 hours via a peripheral vein , with a maximum dose of 150 mg . All patients then received heparin and warfarin for the remainder of the hospitalization . Follow-up venography was performed 24 to 36 hours after initiation of therapy . RESULTS Complete or more than 50 % lysis occurred in 10 ( 28 % ) patients treated with rt-PA , five ( 29 % ) patients with rt-PA plus heparin , and no patient treated with heparin . No lysis occurred in 16 ( 44 % ) patients treated with rt-PA plus heparin , and 10 ( 83 % ) patients who received heparin alone ( p = 0.04 ) . There was one major complication , a nonfatal intracranial hemorrhage in a patient who received rt-PA alone . At 7 to 10 days after initiation of treatment , the level of serum glutamic oxaloacetic transaminase nearly doubled among all patients , including those assigned to receive heparin alone . CONCLUSION ( 1 ) rt-PA and rt-PA plus heparin cause more clot lysis than heparin alone ; ( 2 ) the addition of heparin to rt-PA does not improve the lysis rate ; ( 3 ) DVT treated with heparin is commonly associated with a rise in the transaminase level ; ( 4 ) \n Output:\n " }, { "from": "agent", "value": "The authors determined that thrombolysis therapy results in greater lysis and complication rates than does anticoagulation alone .\nThe authors also found that PTS incidence is lower in patients treated with thrombolytics .\nTherefore , the authors conclude that although the lysis rate is greater for thrombolytic agents , they can not be recommended routinely for DVT treatment" } ]
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: BACKGROUND Post-thrombotic syndrome varies from mild oedema to incapacitating swelling with pain and ulceration . We investigated the rate of post-thrombotic syndrome after a first episode of deep-vein thrombosis and assessed the preventive effect of direct application of a sized-to-fit grade d compression stocking . METHODS Patients with a first episode of venogram-proven proximal deep-vein thrombosis were r and omly assigned no stockings ( the control group ) or made-to-measure grade d compression elastic stockings for at least 2 years . Post-thrombotic syndrome was assessed with a st and ard scoring system that combined clinical characteristics and objective leg measurements . Patients were assessed every 3 months during the first 2 years , and every 6 months thereafter for at least 5 years . The cumulative incidence of mild-to-moderate post-thrombotic syndrome was the primary outcome measure . FINDINGS Of the 315 consecutive out patients considered for inclusion , 44 were excluded and 77 did not consent to take part . 194 patients were r and omly assigned compression stockings ( n = 96 ) or no stockings ( n = 98 ) . The median follow-up was 76 months ( range 60 - 96 ) in both groups . Mild-to-moderate post-thrombotic syndrome ( score > or = 3 plus one clinical sign ) occurred in 19 ( 20 % ) patients in the stocking group and in 46 ( 47 % ) control-group patients ( p < 0.001 ) . 11 ( 11 % ) patients in the stocking group developed severe post-thrombotic syndrome ( score > or = 4 ) , compared with 23 ( 23 % ) patients in the control group ( p < 0.001 ) . In both groups , most cases of post-thrombotic syndrome occurred within 24 months of the acute thrombotic event . INTERPRETATION About 60 % of patients with a first episode of proximal deep-vein thrombosis develop post-thrombotic syndrome within 2 years . A sized-to-fit compression stocking reduced this rate by about 50 % Fibrinolytic treatment of acute deep vein thrombosis ( DVT ) of the leg with high-dose streptokinase ( SK ) ( 100,000 U/h ) in 39 cases , or low-dose SK ( approx 10,000 U/h ) in combination with low-dose heparin in 41 cases , was studied in a prospect i ve r and omized trial . The degree of thrombolysis was similar in both groups and did not correlate with age or size of the thrombus or with fibrinogen level . The degree of late recanalization was also similar in both groups . There were however significantly more patients with postthrombotic changes in the low-dose group than in the high-dose group after a mean follow-up time of 31 and 38 months respectively . In the low-dose group 2 intracranial hemorrhages occurred ( one was fatal ) and one patient died of pulmonary embolism , but there were significantly less allergic side effects to SK . There were no cases of such serious side effects in the highdose group . Although low-dose SK has equal thrombolytic effect it seems inferior to high-dose SK , since it probably causes more severe hemorrhagic side-effects In a prospect i ve study , 174 patients ( 118 women and 56 men , average age 44 years , range 14 to 82 ) with proximal extensive thrombosis received streptokinase ( 100,000 U/hour ) for an average of 2.8 days ( range 0.5 to 7 ) through the catheter of a temporary caval filter . Twenty-seven of 45 ( 60 % ) patients with nonocclusive clots were completely free of clots at the second phlebography versus 17 of 116 ( 14 % ) with occlusive clots ( p less than 0.001 ) . Among nonocclusive clots , proximal ones ( caval , iliac and femoral ) were more easily lysed than popliteal clots ( 88 of 116 [ 76 % ] vs 26 of 58 [ 45 % ] ; p less than 0.001 ) . In 41 of 132 ( 31 % ) patients , a daily injection of contrast medium through the filter-carrying catheter enabled the observation of a clot in the filter , which was lysed by streptokinase . Seventy patients with follow-up greater than 2 years ( median 34 months ) were examined clinical ly . Nineteen of 22 ( 86 % ) patients with venograms free of clots at discharge were free of clinical sequelae versus 16 of 48 ( 33 % ) without normal venograms ( p less than 0.001 ) . It is concluded that : ( 1 ) in the case of occlusive clots , only a few patients were normalized after streptokinase ; ( 2 ) proximal nonocclusive clots were most effectively lysed ; ( 3 ) when venograms were free of clots at discharge , the majority of patients did not have venous sequelae at follow-up ; and ( 4 ) embolic migration seems to occur frequently with streptokinase Twenty patients with clinical signs of deep vein thrombosis of a duration not exceeding 72 hours , and with the condition confirmed phlebographically , were r and omly allocated to one of two groups in a double-blind study . In group 1 the patients received urokinase in a low-dose regimen of 200 000 Ploug units during the first 24 hours , followed by infusion of heparin , 40 000 units daily during the next 5 days . Patients in group 2 received heparin only , 40 000 units daily for 6 days . The clinical course was assessed daily . When the infusion period was completed , the phlebography was repeated , and the results of the two examinations were compared with respect to extent of filling defects and the degree of non-filling of the deep veins . We found no superiority in the regimen consisting of urokinase preceding heparin infusion , compared with that of heparin infusion alone . Most of the patients improved clinical ly during the 6-day infusion period , but the degree of thrombosis , evaluated phlebographically , was unaltered or even deteriorated during the period in all patients except two . Overt bleeding was noted in 6 patients Nineteen cases were reinvestigated 8 - 14 years after treatment with SK or heparin . Judging from personal interviews , foot volumometry and phlebography , treatment with SK appears to be more preferable since it was less often followed by late severe postthrombotic changes In a prospect i ve study all positive phlebographies within the well-defined population of the city of Malmö , Sweden , during 1987 were studied in order to determine the incidence of deep venous thrombosis ( DVT ) . Epidemiological data were analysed for the detection of patient groups at increased risk of DVT . The incidence was found to be equal for both sexes , i.e. 1.6 per 1000 inhabitants a year . Risk factors were found to be in accordance with earlier studies . The median age for men was 66 years , compared to 72 years for women . At diagnosis of DVT , 19 % of subjects had a known malignancy and within 1 year 5 % ( 19 cases ) developed a new malignancy . Of the men , 29 % had postoperative or post-traumatic ( fracture ) DVT , compared to 46 % of the women . Fewer patients with DVT than expected ( 39 % ) belonged to blood group 0 ( 31 % ) ( P less than 0.005 ) . Pulmonary embolism ( PE ) was clinical ly suspected in only 5 % of cases , and diagnosis was verified scintigraphically in 2 % of cases . None of these died of PE , but of 6 patients who were found to have PE at autopsy , four died about 4 weeks after the DVT was diagnosed In a prospect i ve and r and omized multicenter trial the efficacy of intermittent regional and systemic thrombolytic therapy for DVT was evaluated . 137 patients with phlebographically confirmed acute DVT above the calf region were treated with 20 mg of rt-PA for 4 h each day . Thrombolysis was applied either locally via a dorsal pedal vein of the firmly b and aged affected leg or systemically using a cubital vein . Treatment lasted for 4 - 7 days , and during this time unfractionated heparin was applied continuously with the dosage adjusted according to aPTT ( 1.5 - 2.0 times the normal value ) . A second phlebography was performed within 24 h after the end of treatment . Results were evaluated by an independent radiologist who was unaware of the treatment given . Significant thrombolytic results ( e.g. lysis of more than 50 % of the original thrombus and complete recanalization of all affected veins ) were reached in only 1/3 of all patients . Rates of recanalization did not differ in both groups and bleeding complications occurred in 26.5 % . We conclude that intermittent local or systemic application of 20 mg rt-PA seems to be ineffective in the treatment of DVT Bolus urokinase ( Abbokinase ) is effective for initial treatment of deep venous thrombosis but is associated with a high rate of rigors . This r and omized controlled trial was undertaken among patients with deep venous thrombosis to evaluate the efficacy and safety of a novel thrombolytic agent , recombinant urokinase ( rUK ) , administered as three bolus infusions of 1 million U over a 24-hour period versus heparin alone . Of 361 patients with DVT screened , 17 ( 5 % ) were enrolled . Recent surgery was the most common reason for exclusion ( n = 113 , 31 % ) . Images of the patients were obtained at baseline , 24 to 48 hours after r and omization , and before hospital discharge . Two patients in each treatment group had minor clot progression . One patient in the heparin group had no change ; all other patients showed mild ( < 50 % ; n = 5 in each group ) or moderate ( > 50 % ; n = 1 in each group ) improvement . No bleeding complications or rigors developed in patients r and omized to rUK . Mean bleeding times among patients given rUK were not significantly different from mean values of patients given heparin at any of the measured time points available for comparison ( 331 vs 387 seconds at baseline and 381 vs 416 seconds at 24 hours ) . However , mean fibrinogen levels declined with successive urokinase boluses and were significantly lower than levels in patients treated with heparin at 24 ( 233 mg/dl vs 466 mg/dl , p = 0.01 ) and 48 hours ( 270 mg/dl vs 474 mg/dl , p = 0.02 ) . Although bolus rUK had a favorable safety profile , rUK was no more effective than heparin in achieving clot lysis at the doses used in this trial A controlled , prospect i ve study comparing streptokinase and heparin treatment has been completed in 51 patients presenting with acute proximal venous thrombosis of less than 8 days ' clinical duration . Patients were studied by means of pre‐treatment , post‐treatment , 3‐ and 12‐monthly phlebography and pulmonary perfusion scanning and were followed up at 3‐monthly intervals PURPOSE To compare the efficacy and safety of recombinant human tissue-type plasminogen activator ( rt-PA , supplied as Activase ) with heparin alone or rt-PA plus heparin in the treatment of venographically documented proximal deep venous thrombosis ( DVT ) of the leg . PATIENTS AND METHODS Sixty-four patients underwent 65 r and omizations to rt-PA alone ( n = 36 ) , rt-PA plus heparin ( n = 17 ) , or heparin alone ( n = 12 ) in a prospect i ve , multicenter , r and omized , open-label trial , with efficacy assessed by a radiology panel unaware of treatment assignment . Patients r and omly assigned to rt-PA received 0.05 mg/kg/hour for 24 hours via a peripheral vein , with a maximum dose of 150 mg . All patients then received heparin and warfarin for the remainder of the hospitalization . Follow-up venography was performed 24 to 36 hours after initiation of therapy . RESULTS Complete or more than 50 % lysis occurred in 10 ( 28 % ) patients treated with rt-PA , five ( 29 % ) patients with rt-PA plus heparin , and no patient treated with heparin . No lysis occurred in 16 ( 44 % ) patients treated with rt-PA plus heparin , and 10 ( 83 % ) patients who received heparin alone ( p = 0.04 ) . There was one major complication , a nonfatal intracranial hemorrhage in a patient who received rt-PA alone . At 7 to 10 days after initiation of treatment , the level of serum glutamic oxaloacetic transaminase nearly doubled among all patients , including those assigned to receive heparin alone . CONCLUSION ( 1 ) rt-PA and rt-PA plus heparin cause more clot lysis than heparin alone ; ( 2 ) the addition of heparin to rt-PA does not improve the lysis rate ; ( 3 ) DVT treated with heparin is commonly associated with a rise in the transaminase level ; ( 4 ) Output:
MS211637
[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: The necessity of tendon interposition for the maintenance of joint space after basal joint resection arthroplasty with ligament reconstruction has not been established . A prospect i ve , r and omized study was performed . In Group I ( nine patients ) , ligament reconstruction was performed to suspend the first metacarpal in addition to placement of a rolled tendon interposition to fill the void created by resection of the trapezium . In Group II ( 11 patients ) , ligament reconstruction alone was performed , with use of a Mitek suture anchor . No tendon interposition was performed . This allowed use of a more limited incision and shorter length of tendon graft . Average followup was 23 months . There was no difference between the two groups in range of motion of the thumb , grip strength , lateral pinch strength , the ability to perform activities of daily living , or subjective satisfaction with the procedure . Two- and three-point pinch strength was statistically significantly greater in Group II . Lateral radiographs of the basal joint at followup , at rest and with pinch , showed maintenance of the joint space , and no difference between the two groups . Tendon interposition is not necessary for maintenance of joint space after basal joint resection arthroplasty if ligament reconstruction is performed Seventy-three thumbs in 67 women with osteoarthritis of the trapeziometacarpal joint were assessed prospect ively . The patients were r and omly allocated for treatment by either trapeziectomy alone ( n = 26 ) or trapeziectomy with tendon interposition ( n = 23 ) or ligament reconstruction ( n = 24 ) . A K-wire was passed through the thumb metacarpal base and across the trapezial space into the distal pole of the scaphoid in all procedures ; this held the base of the metacarpal away from the scaphoid for 4 weeks . St and ard thumb radiographs were used to calculate the trapezial space ratio before surgery and at 1-year follow-up examination . The trapezial space ratio decreased significantly from a preoperative mean of 0.40 ( range , 0.20 - 0.56 ) to a mean of 0.18 ( range , 0.08 - 0.30 ) after trapeziectomy , 0.16 ( range , 0.07 - 0.30 ) after trapeziectomy with tendon interposition , and 0.20 ( range , 0.00 - 0.33 ) after trapeziectomy with ligament reconstruction . There was no significant difference between these 1-year follow-up trapezial space ratios , suggesting that the placement of a K-wire across the trapezial void is as effective as tendon interposition or ligament reconstruction in creating a trapezial space in the short term at least . However , the need to create a trapezial space and maintain thumb length is question ed because the trapezial space height did not correlate with thumb strength at 1-year follow-up examination Forty-three h and s in 41 adults with osteoarthrosis of the trapeziometacarpal joint were allocated r and omly to undergo a trapeziectomy through either an anterior approach or the posterior ( dorsoradial ) approach . Forty h and s were available for review at a median of 33 months postoperatively . The demographic characteristics , severity of disease and pre-operative measurements of the two groups were indistinguishable . Trapeziectomy result ed in significantly improved objective and subjective function in both groups , but the anterior approach group had better outcomes for power , scar tenderness and satisfaction . Scar-related complications were three times more common in the posterior group . Trapeziectomy is a good method of treating osteoarthritis of the thumb base , but outcomes for the anterior approach are equally good or better than with the posterior PURPOSE A new spacer for the trapeziometacarpal joint ( TMC ) based on a biological and tissue-preserving concept for the treatment of TMC osteoarthritis ( OA ) has been evaluated . The purpose was to combine a spacing effect with stabilization of the TMC joint . METHODS Artelon ( Artimplant AB , Sweden ) TMC Spacer is synthesized of a degradable polyurethaneurea ( Artelon ) , which has been shown to be biocompatible over time and currently is used in ligament augmentation procedures . Fibers of the polymer were woven into a T-shaped device in which the vertical portion separates the bone edges of the TMC joint and the horizontal portion stabilizes the joint . Fifteen patients with disabling pain and isolated TMC OA were included in the study . Ten patients received the spacer device and the remaining 5 ( control group ) were treated with a trapezium resection arthroplasty with abductor pollicis longus ( APL ) stabilization . The median ages of the 2 groups were 60 and 59 years , respectively . Pain , strength , stability , and range of motion were measured before and after surgery . Radiographic examination was performed in all patients before and after surgery . At follow-up evaluation 3 years after surgery an unbiased observer evaluated all patients . Biopsy specimens were obtained from 1 patient 6 months after surgery . RESULTS All patients were stable clinical ly without signs of synovitis . In both groups all patients were pain free . The median values for both key pinch and tripod pinch increased compared with before surgery in the spacer group but not in the APL group . The biopsy examinations showed incorporation of the device in the surface of the adjacent bone and the surrounding connective tissue . No signs of foreign-body reaction were seen . CONCLUSIONS This study showed significantly better pinch strength after Artelon TMC Spacer implantation into the TMC joint compared with APL arthroplasty Twenty-six h and s in 26 adults with osteoarthrosis of the thumb trapeziometacarpal joint were r and omised to undergo either trapeziectomy alone ( control ) or with the interposition of porcine dermal collagen xenograft ( Permacol ™ ) . The study was terminated prematurely because of apparent reactions to the implants in six of 13 patients . The collagen interposition group required more frequent review on clinical grounds and were discharged later after surgery . Three of the implants have been removed and histology revealed foreign body reactions in all . There was no difference in thumb movement or power after surgery between the two groups . However , improved grip strength was observed and improved function were reported only in the control group . Permacol patients reported greater pain and were less satisfied with their operations than control patients . We conclude that interposition of Permacol is detrimental to the results of trapeziectomy This r and omized prospect i ve study compared the results of trapeziectomy alone , or combined with tendon interposition or ligament reconstruction in 76 women with basal thumb osteoarthritis . At 3 month and 1 year follow-up the results of the three procedures were indistinguishable in terms of pain relief , h and function and thumb strength . In the short term at least , tendon interposition and ligament reconstruction do not improve the results of trapeziectomy Forty-three patients were r and omly allocated to undergo either trapeziectomy alone ( control ) or with a ligament reconstruction and tendon interposition ( LRTI ) using an abductor pollicis longus tendon slip . The patients were review ed at a median 13 ( range , 7–29 ) months after surgery . The demographic characteristics , severity of disease and pre-operative clinical measurements of the two study groups were indistinguishable but LRTI lengthened the operation by approximately 15 minutes . Both groups expressed equal satisfaction with the operation and there were no significant differences between the two treatment groups . Simple trapeziectomy is an effective operation for osteoarthrosis at the base of the thumb and the addition of a ligament reconstruction was not shown to confer any additional benefit \n Output:\n " }, { "from": "agent", "value": "2 ) Trapeziectomy with ligament reconstruction or trapeziectomy with ligament reconstruction and tendon interposition ( LRTI ) is not superior to any of the other techniques .\nIn addition , trapeziectomy with LRTI seems associated with a higher complication rate .\n( 3 ) Because the studies on thumb carpometacarpal ( CMC ) arthrodesis were of less method ological quality and had inconsistent outcomes , we are not able to conclude whether CMC arthrodesis is superior to any other technique .\n4 ) A study on joint replacement showed that total joint prosthesis might have better short-term results compared to trapeziectomy with LRTI .\nIn addition , there is no evidence that the Artelon spacer is superior to trapeziectomy with LRTI .\nWe conclude that , at this time , no surgical procedure is proven to be superior to another .\nHowever , based on good results of CMC arthrodesis and total joint prostheses , we postulate that there could be differences between the various surgical procedures ." } ]
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: The necessity of tendon interposition for the maintenance of joint space after basal joint resection arthroplasty with ligament reconstruction has not been established . A prospect i ve , r and omized study was performed . In Group I ( nine patients ) , ligament reconstruction was performed to suspend the first metacarpal in addition to placement of a rolled tendon interposition to fill the void created by resection of the trapezium . In Group II ( 11 patients ) , ligament reconstruction alone was performed , with use of a Mitek suture anchor . No tendon interposition was performed . This allowed use of a more limited incision and shorter length of tendon graft . Average followup was 23 months . There was no difference between the two groups in range of motion of the thumb , grip strength , lateral pinch strength , the ability to perform activities of daily living , or subjective satisfaction with the procedure . Two- and three-point pinch strength was statistically significantly greater in Group II . Lateral radiographs of the basal joint at followup , at rest and with pinch , showed maintenance of the joint space , and no difference between the two groups . Tendon interposition is not necessary for maintenance of joint space after basal joint resection arthroplasty if ligament reconstruction is performed Seventy-three thumbs in 67 women with osteoarthritis of the trapeziometacarpal joint were assessed prospect ively . The patients were r and omly allocated for treatment by either trapeziectomy alone ( n = 26 ) or trapeziectomy with tendon interposition ( n = 23 ) or ligament reconstruction ( n = 24 ) . A K-wire was passed through the thumb metacarpal base and across the trapezial space into the distal pole of the scaphoid in all procedures ; this held the base of the metacarpal away from the scaphoid for 4 weeks . St and ard thumb radiographs were used to calculate the trapezial space ratio before surgery and at 1-year follow-up examination . The trapezial space ratio decreased significantly from a preoperative mean of 0.40 ( range , 0.20 - 0.56 ) to a mean of 0.18 ( range , 0.08 - 0.30 ) after trapeziectomy , 0.16 ( range , 0.07 - 0.30 ) after trapeziectomy with tendon interposition , and 0.20 ( range , 0.00 - 0.33 ) after trapeziectomy with ligament reconstruction . There was no significant difference between these 1-year follow-up trapezial space ratios , suggesting that the placement of a K-wire across the trapezial void is as effective as tendon interposition or ligament reconstruction in creating a trapezial space in the short term at least . However , the need to create a trapezial space and maintain thumb length is question ed because the trapezial space height did not correlate with thumb strength at 1-year follow-up examination Forty-three h and s in 41 adults with osteoarthrosis of the trapeziometacarpal joint were allocated r and omly to undergo a trapeziectomy through either an anterior approach or the posterior ( dorsoradial ) approach . Forty h and s were available for review at a median of 33 months postoperatively . The demographic characteristics , severity of disease and pre-operative measurements of the two groups were indistinguishable . Trapeziectomy result ed in significantly improved objective and subjective function in both groups , but the anterior approach group had better outcomes for power , scar tenderness and satisfaction . Scar-related complications were three times more common in the posterior group . Trapeziectomy is a good method of treating osteoarthritis of the thumb base , but outcomes for the anterior approach are equally good or better than with the posterior PURPOSE A new spacer for the trapeziometacarpal joint ( TMC ) based on a biological and tissue-preserving concept for the treatment of TMC osteoarthritis ( OA ) has been evaluated . The purpose was to combine a spacing effect with stabilization of the TMC joint . METHODS Artelon ( Artimplant AB , Sweden ) TMC Spacer is synthesized of a degradable polyurethaneurea ( Artelon ) , which has been shown to be biocompatible over time and currently is used in ligament augmentation procedures . Fibers of the polymer were woven into a T-shaped device in which the vertical portion separates the bone edges of the TMC joint and the horizontal portion stabilizes the joint . Fifteen patients with disabling pain and isolated TMC OA were included in the study . Ten patients received the spacer device and the remaining 5 ( control group ) were treated with a trapezium resection arthroplasty with abductor pollicis longus ( APL ) stabilization . The median ages of the 2 groups were 60 and 59 years , respectively . Pain , strength , stability , and range of motion were measured before and after surgery . Radiographic examination was performed in all patients before and after surgery . At follow-up evaluation 3 years after surgery an unbiased observer evaluated all patients . Biopsy specimens were obtained from 1 patient 6 months after surgery . RESULTS All patients were stable clinical ly without signs of synovitis . In both groups all patients were pain free . The median values for both key pinch and tripod pinch increased compared with before surgery in the spacer group but not in the APL group . The biopsy examinations showed incorporation of the device in the surface of the adjacent bone and the surrounding connective tissue . No signs of foreign-body reaction were seen . CONCLUSIONS This study showed significantly better pinch strength after Artelon TMC Spacer implantation into the TMC joint compared with APL arthroplasty Twenty-six h and s in 26 adults with osteoarthrosis of the thumb trapeziometacarpal joint were r and omised to undergo either trapeziectomy alone ( control ) or with the interposition of porcine dermal collagen xenograft ( Permacol ™ ) . The study was terminated prematurely because of apparent reactions to the implants in six of 13 patients . The collagen interposition group required more frequent review on clinical grounds and were discharged later after surgery . Three of the implants have been removed and histology revealed foreign body reactions in all . There was no difference in thumb movement or power after surgery between the two groups . However , improved grip strength was observed and improved function were reported only in the control group . Permacol patients reported greater pain and were less satisfied with their operations than control patients . We conclude that interposition of Permacol is detrimental to the results of trapeziectomy This r and omized prospect i ve study compared the results of trapeziectomy alone , or combined with tendon interposition or ligament reconstruction in 76 women with basal thumb osteoarthritis . At 3 month and 1 year follow-up the results of the three procedures were indistinguishable in terms of pain relief , h and function and thumb strength . In the short term at least , tendon interposition and ligament reconstruction do not improve the results of trapeziectomy Forty-three patients were r and omly allocated to undergo either trapeziectomy alone ( control ) or with a ligament reconstruction and tendon interposition ( LRTI ) using an abductor pollicis longus tendon slip . The patients were review ed at a median 13 ( range , 7–29 ) months after surgery . The demographic characteristics , severity of disease and pre-operative clinical measurements of the two study groups were indistinguishable but LRTI lengthened the operation by approximately 15 minutes . Both groups expressed equal satisfaction with the operation and there were no significant differences between the two treatment groups . Simple trapeziectomy is an effective operation for osteoarthrosis at the base of the thumb and the addition of a ligament reconstruction was not shown to confer any additional benefit Output:
MS2629
[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Chromoendoscopy can accurately differentiate neoplastic from nonneoplastic polyps in the colon . Narrow b and imaging ( NBI ) has been described as \" electronic chromoendoscopy , \" but it is unclear whether pit patterns seen with chromoendoscopy are identical to those with NBI . OBJECTIVE Pilot study to compare features of diminutive polyps assessed with magnification NBI and chromoendoscopy . DESIGN Prospect i ve polyp series . SETTING Single tertiary referral center in the United Kingdom . PATIENTS Twenty patients seen for routine colonoscopy . INTERVENTION Digital images of each polyp recorded with NBI and chromoendoscopy were subsequently assessed as single images in a r and om order and as paired polyp images by experienced European- and Japanese-trained endoscopists . MAIN OUTCOME MEASUREMENTS Pit pattern ( Kudo classification ) ; vascular pattern intensity ( weak , normal , strong ) ; predicted histology ; pit pattern and vessel network clarity ( scale 1 - 3 , 1 poor , 3 excellent ) . RESULTS A total of 33 polyps < or=6 mm were assessed . Chromoendoscopic and NBI pit patterns were different for 12 and 20 of 33 polyps ( Japanese and European , respectively ) , combined kappa 0.23 , P < .001 compared with published intraobsever variation . Sensitivity , specificity , and accuracy for neoplasia were comparable for chromoendoscopic and NBI pit patterns and vascular pattern intensity for both observers . Vessel network clarity was better with NBI , P < .001 ( both ) , as was pit pattern clarity , P = .04 ( European ) . LIMITATIONS Small sample size ; pilot study . CONCLUSIONS Pit patterns were not always identical with NBI and chromoendoscopy . The Kudo classification may need to be modified and revali date d before it can be used with confidence with NBI . Vascular pattern intensity , a simple color change , appears as accurate as pit pattern Context How often does colonoscopy miss adenomas ? Contribution During a multicenter screening trial , experienced colonoscopists performed same-day optical ( OC ) and virtual colonoscopy ( VC ) on 1233 asymptomatic adults . Optical colonoscopy performed without knowledge of the VC findings missed 55 of 511 polyps ; 21 of these polyps were adenomas measuring 6 mm or greater . Adenomas missed by OC were usually on the proximal side of a fold or near the anal verge . Virtual colonoscopy missed 14 % of the adenomas that measured 6 mm or greater that were de-tected by OC . Implication s Neither OC nor VC is a perfect test : Each misses 10 % to 14 % of adenomas that measure 6 mm or greater . The Editors Optical colonoscopy ( OC ) is widely accepted as the gold st and ard for detecting colorectal neoplasia ( 1 , 2 ) . However , even in the most experienced h and s , this skilled examination is underst and ably not infallible . Retrospective analysis has suggested that the OC miss rate for adenomas 10 mm or greater is approximately 10 % ( 3 ) . More recently , prospect i ve back-to-back or t and em colonoscopy studies have reported miss rates for 10-mm adenomas ranging from 0 % to 6 % ( 4 , 5 ) . However , in addition to evaluating relatively small population s of patients with a high prevalence of polyps , a notable weakness common to these studies was that they used OC as its own reference st and ard . In a large , prospect i ve , multicenter trial that was primarily intended to evaluate the performance of virtual colonoscopy ( VC ) in asymptomatic adults ( 6 ) , we also had a unique opportunity to evaluate the adenoma miss rate on OC by segmentally unblinding the results from same-day VC . By using a reference st and ard other than OC itself for comparison , we could uncover lesions that may be systematic ally missed on repeated colonoscopies . These data not only provide novel insight into OC miss rates but also indicate the relative blind spots where more attention could be focused . Methods Study Design The institutional review boards at all 3 participating medical centers approved the study protocol for same-day VC and OC , and all patients provided written informed consent . We recruited asymptomatic adults who were referred for colorectal cancer screening . Exclusion criteria were a positive stool guiaic test result or iron deficiency anemia within the past 6 months ; rectal bleeding , hematochezia , or unintentional weight loss of more than 10 pounds within the past 12 months ; OC within the past 10 years or barium enema within the past 5 years ; personal history of adenomatous polyps , colorectal cancer , or inflammatory bowel disease ; and family history of familial adenomatous polyposis or nonpolyposis cancer syndromes . Between May 2002 and June 2003 , 1253 asymptomatic adults enrolled in the study . Eight patients were excluded because of failure to reach the cecum at OC , 6 patients were excluded because of inadequate colonic preparation , and another 6 patients were excluded because of computed tomography ( CT ) system failure . The final study group comprised 1233 asymptomatic adults ( 728 men and 505 women ; mean age , 57.8 years ) who successfully completed same-day VC and OC . Study participants underwent colonic preparation with oral intake of 90 mL of phospho-soda and 10 mg of bisacodyl . To opacify residual colonic fluid and stool for VC examination , patients also consumed dilute oral contrast as previously described ( 7 ) . Our CT protocol and VC technique have also been detailed previously ( 6 ) . To briefly summarize , we obtained supine and prone CT acquisitions on multidetector scanners after patient-controlled rectal insufflation of room air . One of 6 trained radiologists interpreted VC studies by using a commercially available CT colonography system ( Viatronix V3D-Colon , version 1.2 , Viatronix , Inc. , Stony Brook , New York ) . We used the 3-dimensional endoluminal fly-through view primarily for detecting polyps and 2-dimensional images for confirmation and problem solving . We measured polyps on the 3-dimensional view and recorded them by segment ( cecum , ascending colon , hepatic flexure , transverse colon , splenic flexure , descending colon , sigmoid colon , or rectum ) . We defined the proximal colon as including the cecum to the splenic flexure . We prospect ively rated diagnostic confidence for each detected lesion on a 3-point scale ( most certain , intermediate , and least certain ) . One of 17 experienced colonoscopists performed OC immediately after VC interpretation by using st and ard commercial video colonoscopes ( Olympus , Inc. , Melville , New York ) . The colonoscope was advanced to the cecum and then sequentially withdrawn into more distal segments for polyp detection . The colonoscopist measured polyps by using a calibrated linear probe , which is more accurate than either visual or biopsy forceps estimation ( 8) . Our polyp-matching algorithm requires VC and OC agreement according to size ( within a 50 % margin of error ) and location ( within the same or adjacent segment ) . After the colonoscopist evaluated a given segment , a study nurse unblinded the VC results for the previous segment . For any suspected polyp seen on VC that measured 5 mm or greater but was not seen on the initial blinded OC , the colonoscopist closely reexamined that segment and could review the VC images for guidance . We sent all retrieved polyps for histologic examination . For all cases in which a colorectal neoplasm measuring 6 mm or greater was found on second-look OC , we retrospectively review ed both the VC and OC images . We recorded polyp characteristics , such as size , morphologic characteristic ( sessile , pedunculated , or flat ) , and location on VC . If the polyp was situated on a colonic fold on VC , we further subcategorized it as being located on the back ( proximal ) side , front ( distal ) side , or edge of the fold . We analyzed both supine and prone VC sets for all cases . The primary reason that diminutive polyps measuring 5 mm at VC were included for potential unblinding at OC was that , given the relative error in polyp measurement , such polyps found on second-look OC might , in fact , measure 6 mm or greater . This allows for more accurate assessment of the OC miss rate at the 6-mm threshold . We did not include unblinded polyps that measured 5 mm or less on both VC and OC examinations in the final analysis . All study participants completed a detailed question naire on their personal and family medical history . For the purpose s of this study , particular attention was given to the question about previous abdominal or pelvic surgery , since adhesions could conceivably result in a more difficult colonoscopic examination . Statistical Analysis Prospect i ve OC performance was compared against the enhanced reference st and ard of second-look OC after segmental unblinding of VC results . We estimated exact binomial 95 % CIs for OC miss rates . We used the chi-square test to compare the frequency of previous abdominal surgery among patients with and without polyps missed at OC and also to compare the OC miss rates among the 3 medical centers . We calculated the 95 % CIs by using Stata software , version 7.0 for Windows ( Stata Corp. , College Station , Texas ) , and performed the chi-square tests by using SAS software , version 8.0 for Windows ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results The performance characteristics of VC from this prospect i ve , multicenter screening trial , using OC as the reference st and ard , have been previously reported ( 6 ) . Our technique of segmental unblinding also allows for a separate assessment of OC by using the blinded VC results for comparison , which is the focus of this study . We identified 1310 polyps at OC in the 1233 asymptomatic adults ; 511 ( 39.0 % ) of these polyps measured 5 mm or greater ( Figure 1).Of these 511 polyps , 55 ( 10.8 % ) were found only on second-look OC after segmental unblinding of VC results . Twenty-four ( 43.6 % ) of the 55 unblinded lesions were nonadenomatous , including 16 hyperplastic polyps . Of the 31 missed neoplasms , 10 adenomas that measured only 5 mm were excluded from further analysis because of their diminutive size ( 9 ) . Including unblinded lesions , 554 adenomas were detected on OC in this screening sample ; 210 of these measured 6 mm or greater and 51 measured 10 mm or greater . Figure 1 . Polyp flowchart . In 20 patients ( 17 men and 3 women ; mean age , 58.2 years ) , 21 adenomas measuring 6 mm or greater ( range , 6 mm to 17 mm ; mean , 8.1 mm ) were found on OC only after the VC results were unblinded , which represent the lesions of primary interest for this study ( Table ) . The corresponding adenoma miss rate on prospect i ve OC examination was 10.0 % ( 95 % CI , 6.3 % to 14.9 % ) ( 21 of 210 adenomas ) at a 6-mm cutoff . The 20 patients with missed adenomas that measured 6 mm or greater represented only 1.6 % of the study sample ( 20 of 1233 patients ) but 11.9 % of patients with adenomas 6 mm or greater ( 20 of 168 patients ) . At 8-mm and 10-mm thresholds , the OC adenoma miss rates by polyp were 10.5 % ( CI , 5.2 % to 18.5 % ) ( 10 of 95 adenomas ) and 11.8 % ( CI , 4.4 % to 23.9 % ) ( 6 of 51 adenomas ) , respectively . The 10 patients with missed adenomas 8 mm or greater represented 12.2 % ( 10 of 82 patients ) of all patients with neoplasms of this size or greater ; the 6 patients with missed adenomas 8 mm or greater represented 12.5 % of all patients with neoplasms 10 mm or greater . Table . Characteristics of Neoplasms Missed at Prospect i ve Colonoscopic Evaluation Seventeen ( 81.0 % ) of the 21 unblinded neoplasms 6 mm or greater were tubular adenomas , 3 ( 14.3 % ) were tubulovillous adenomas , and 1 ( 4.8 % ) was an adenocarcinoma . Seven ( 33.3 % ) of the 21 unblinded polyps were classified as advanced lesions ( that is , size 10 mm or high- grade dysplasia , prominent villous component , or focus of malignancy ) . There were 15 sessile lesions , 4 pedunculated lesions , and 2 flat An important determinant in interpreting the results of colorectal polyp chemoprevention trials is the rate of polyps missed during colonscopic examination . We prospect ively examined 90 patients by t and em colonoscopy performed by two alternating examiners . In 69 ( 76.7 % ) patients , 221 neoplastic lesions were documented histologically . Of a total of 58 lesions detected in 31 patients , no neoplastic lesion greater than or equal to 10 mm in size was missed ; 16 % of diminutive ( less than or equal to 5 mm ) neop \n Output:\n " }, { "from": "agent", "value": "We could not find convincing evidence that NBI is significantly better than high definition WLC for the detection of patients with colorectal polyps , or colorectal adenomas .\nWe found evidence that NBI might be better than st and ard definition WLC and equal to high definition WLC for detection the patients with colorectal polyps , or colorectal adenomas" } ]
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: BACKGROUND Chromoendoscopy can accurately differentiate neoplastic from nonneoplastic polyps in the colon . Narrow b and imaging ( NBI ) has been described as " electronic chromoendoscopy , " but it is unclear whether pit patterns seen with chromoendoscopy are identical to those with NBI . OBJECTIVE Pilot study to compare features of diminutive polyps assessed with magnification NBI and chromoendoscopy . DESIGN Prospect i ve polyp series . SETTING Single tertiary referral center in the United Kingdom . PATIENTS Twenty patients seen for routine colonoscopy . INTERVENTION Digital images of each polyp recorded with NBI and chromoendoscopy were subsequently assessed as single images in a r and om order and as paired polyp images by experienced European- and Japanese-trained endoscopists . MAIN OUTCOME MEASUREMENTS Pit pattern ( Kudo classification ) ; vascular pattern intensity ( weak , normal , strong ) ; predicted histology ; pit pattern and vessel network clarity ( scale 1 - 3 , 1 poor , 3 excellent ) . RESULTS A total of 33 polyps < or=6 mm were assessed . Chromoendoscopic and NBI pit patterns were different for 12 and 20 of 33 polyps ( Japanese and European , respectively ) , combined kappa 0.23 , P < .001 compared with published intraobsever variation . Sensitivity , specificity , and accuracy for neoplasia were comparable for chromoendoscopic and NBI pit patterns and vascular pattern intensity for both observers . Vessel network clarity was better with NBI , P < .001 ( both ) , as was pit pattern clarity , P = .04 ( European ) . LIMITATIONS Small sample size ; pilot study . CONCLUSIONS Pit patterns were not always identical with NBI and chromoendoscopy . The Kudo classification may need to be modified and revali date d before it can be used with confidence with NBI . Vascular pattern intensity , a simple color change , appears as accurate as pit pattern Context How often does colonoscopy miss adenomas ? Contribution During a multicenter screening trial , experienced colonoscopists performed same-day optical ( OC ) and virtual colonoscopy ( VC ) on 1233 asymptomatic adults . Optical colonoscopy performed without knowledge of the VC findings missed 55 of 511 polyps ; 21 of these polyps were adenomas measuring 6 mm or greater . Adenomas missed by OC were usually on the proximal side of a fold or near the anal verge . Virtual colonoscopy missed 14 % of the adenomas that measured 6 mm or greater that were de-tected by OC . Implication s Neither OC nor VC is a perfect test : Each misses 10 % to 14 % of adenomas that measure 6 mm or greater . The Editors Optical colonoscopy ( OC ) is widely accepted as the gold st and ard for detecting colorectal neoplasia ( 1 , 2 ) . However , even in the most experienced h and s , this skilled examination is underst and ably not infallible . Retrospective analysis has suggested that the OC miss rate for adenomas 10 mm or greater is approximately 10 % ( 3 ) . More recently , prospect i ve back-to-back or t and em colonoscopy studies have reported miss rates for 10-mm adenomas ranging from 0 % to 6 % ( 4 , 5 ) . However , in addition to evaluating relatively small population s of patients with a high prevalence of polyps , a notable weakness common to these studies was that they used OC as its own reference st and ard . In a large , prospect i ve , multicenter trial that was primarily intended to evaluate the performance of virtual colonoscopy ( VC ) in asymptomatic adults ( 6 ) , we also had a unique opportunity to evaluate the adenoma miss rate on OC by segmentally unblinding the results from same-day VC . By using a reference st and ard other than OC itself for comparison , we could uncover lesions that may be systematic ally missed on repeated colonoscopies . These data not only provide novel insight into OC miss rates but also indicate the relative blind spots where more attention could be focused . Methods Study Design The institutional review boards at all 3 participating medical centers approved the study protocol for same-day VC and OC , and all patients provided written informed consent . We recruited asymptomatic adults who were referred for colorectal cancer screening . Exclusion criteria were a positive stool guiaic test result or iron deficiency anemia within the past 6 months ; rectal bleeding , hematochezia , or unintentional weight loss of more than 10 pounds within the past 12 months ; OC within the past 10 years or barium enema within the past 5 years ; personal history of adenomatous polyps , colorectal cancer , or inflammatory bowel disease ; and family history of familial adenomatous polyposis or nonpolyposis cancer syndromes . Between May 2002 and June 2003 , 1253 asymptomatic adults enrolled in the study . Eight patients were excluded because of failure to reach the cecum at OC , 6 patients were excluded because of inadequate colonic preparation , and another 6 patients were excluded because of computed tomography ( CT ) system failure . The final study group comprised 1233 asymptomatic adults ( 728 men and 505 women ; mean age , 57.8 years ) who successfully completed same-day VC and OC . Study participants underwent colonic preparation with oral intake of 90 mL of phospho-soda and 10 mg of bisacodyl . To opacify residual colonic fluid and stool for VC examination , patients also consumed dilute oral contrast as previously described ( 7 ) . Our CT protocol and VC technique have also been detailed previously ( 6 ) . To briefly summarize , we obtained supine and prone CT acquisitions on multidetector scanners after patient-controlled rectal insufflation of room air . One of 6 trained radiologists interpreted VC studies by using a commercially available CT colonography system ( Viatronix V3D-Colon , version 1.2 , Viatronix , Inc. , Stony Brook , New York ) . We used the 3-dimensional endoluminal fly-through view primarily for detecting polyps and 2-dimensional images for confirmation and problem solving . We measured polyps on the 3-dimensional view and recorded them by segment ( cecum , ascending colon , hepatic flexure , transverse colon , splenic flexure , descending colon , sigmoid colon , or rectum ) . We defined the proximal colon as including the cecum to the splenic flexure . We prospect ively rated diagnostic confidence for each detected lesion on a 3-point scale ( most certain , intermediate , and least certain ) . One of 17 experienced colonoscopists performed OC immediately after VC interpretation by using st and ard commercial video colonoscopes ( Olympus , Inc. , Melville , New York ) . The colonoscope was advanced to the cecum and then sequentially withdrawn into more distal segments for polyp detection . The colonoscopist measured polyps by using a calibrated linear probe , which is more accurate than either visual or biopsy forceps estimation ( 8) . Our polyp-matching algorithm requires VC and OC agreement according to size ( within a 50 % margin of error ) and location ( within the same or adjacent segment ) . After the colonoscopist evaluated a given segment , a study nurse unblinded the VC results for the previous segment . For any suspected polyp seen on VC that measured 5 mm or greater but was not seen on the initial blinded OC , the colonoscopist closely reexamined that segment and could review the VC images for guidance . We sent all retrieved polyps for histologic examination . For all cases in which a colorectal neoplasm measuring 6 mm or greater was found on second-look OC , we retrospectively review ed both the VC and OC images . We recorded polyp characteristics , such as size , morphologic characteristic ( sessile , pedunculated , or flat ) , and location on VC . If the polyp was situated on a colonic fold on VC , we further subcategorized it as being located on the back ( proximal ) side , front ( distal ) side , or edge of the fold . We analyzed both supine and prone VC sets for all cases . The primary reason that diminutive polyps measuring 5 mm at VC were included for potential unblinding at OC was that , given the relative error in polyp measurement , such polyps found on second-look OC might , in fact , measure 6 mm or greater . This allows for more accurate assessment of the OC miss rate at the 6-mm threshold . We did not include unblinded polyps that measured 5 mm or less on both VC and OC examinations in the final analysis . All study participants completed a detailed question naire on their personal and family medical history . For the purpose s of this study , particular attention was given to the question about previous abdominal or pelvic surgery , since adhesions could conceivably result in a more difficult colonoscopic examination . Statistical Analysis Prospect i ve OC performance was compared against the enhanced reference st and ard of second-look OC after segmental unblinding of VC results . We estimated exact binomial 95 % CIs for OC miss rates . We used the chi-square test to compare the frequency of previous abdominal surgery among patients with and without polyps missed at OC and also to compare the OC miss rates among the 3 medical centers . We calculated the 95 % CIs by using Stata software , version 7.0 for Windows ( Stata Corp. , College Station , Texas ) , and performed the chi-square tests by using SAS software , version 8.0 for Windows ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results The performance characteristics of VC from this prospect i ve , multicenter screening trial , using OC as the reference st and ard , have been previously reported ( 6 ) . Our technique of segmental unblinding also allows for a separate assessment of OC by using the blinded VC results for comparison , which is the focus of this study . We identified 1310 polyps at OC in the 1233 asymptomatic adults ; 511 ( 39.0 % ) of these polyps measured 5 mm or greater ( Figure 1).Of these 511 polyps , 55 ( 10.8 % ) were found only on second-look OC after segmental unblinding of VC results . Twenty-four ( 43.6 % ) of the 55 unblinded lesions were nonadenomatous , including 16 hyperplastic polyps . Of the 31 missed neoplasms , 10 adenomas that measured only 5 mm were excluded from further analysis because of their diminutive size ( 9 ) . Including unblinded lesions , 554 adenomas were detected on OC in this screening sample ; 210 of these measured 6 mm or greater and 51 measured 10 mm or greater . Figure 1 . Polyp flowchart . In 20 patients ( 17 men and 3 women ; mean age , 58.2 years ) , 21 adenomas measuring 6 mm or greater ( range , 6 mm to 17 mm ; mean , 8.1 mm ) were found on OC only after the VC results were unblinded , which represent the lesions of primary interest for this study ( Table ) . The corresponding adenoma miss rate on prospect i ve OC examination was 10.0 % ( 95 % CI , 6.3 % to 14.9 % ) ( 21 of 210 adenomas ) at a 6-mm cutoff . The 20 patients with missed adenomas that measured 6 mm or greater represented only 1.6 % of the study sample ( 20 of 1233 patients ) but 11.9 % of patients with adenomas 6 mm or greater ( 20 of 168 patients ) . At 8-mm and 10-mm thresholds , the OC adenoma miss rates by polyp were 10.5 % ( CI , 5.2 % to 18.5 % ) ( 10 of 95 adenomas ) and 11.8 % ( CI , 4.4 % to 23.9 % ) ( 6 of 51 adenomas ) , respectively . The 10 patients with missed adenomas 8 mm or greater represented 12.2 % ( 10 of 82 patients ) of all patients with neoplasms of this size or greater ; the 6 patients with missed adenomas 8 mm or greater represented 12.5 % of all patients with neoplasms 10 mm or greater . Table . Characteristics of Neoplasms Missed at Prospect i ve Colonoscopic Evaluation Seventeen ( 81.0 % ) of the 21 unblinded neoplasms 6 mm or greater were tubular adenomas , 3 ( 14.3 % ) were tubulovillous adenomas , and 1 ( 4.8 % ) was an adenocarcinoma . Seven ( 33.3 % ) of the 21 unblinded polyps were classified as advanced lesions ( that is , size 10 mm or high- grade dysplasia , prominent villous component , or focus of malignancy ) . There were 15 sessile lesions , 4 pedunculated lesions , and 2 flat An important determinant in interpreting the results of colorectal polyp chemoprevention trials is the rate of polyps missed during colonscopic examination . We prospect ively examined 90 patients by t and em colonoscopy performed by two alternating examiners . In 69 ( 76.7 % ) patients , 221 neoplastic lesions were documented histologically . Of a total of 58 lesions detected in 31 patients , no neoplastic lesion greater than or equal to 10 mm in size was missed ; 16 % of diminutive ( less than or equal to 5 mm ) neop Output:
MS24792
[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: Background The aim was to prove the low identification rate of sentinel lymph node biopsy ( SNB ) and to determine the feasibility of replacing axillary lymph node dissection ( AND ) in axillary lymph node positive patients after chemotherapy . Methods From October 2001 to July 2005 , 875 consecutive patients with primary operable breast cancer underwent SNB and AND . Among them , 238 received pre-operative chemotherapy . We compared the identification rate , false negative rate ( FNR ) , negative predictive value ( NPV ) , and accuracy of SNB in clinical ly node-positive patients with or without chemotherapy . Results The identification rate was significantly lower in patients received chemotherapy ( 77.6 % ) than in those not received it ( 97.0 % ) ( P < 0.001 ) . In those received the therapy , the FNR was 5.6 % , the NPV was 86.8 % , and the accuracy was 95.9 % . In those not received therapy , the FNR was 7.4 % and the accuracy was 92.6 % ( differences not statistically significant ) . Conclusion The identification rate in confirmed axillary lymph node-positive patients was significantly lower in patients received pre-operative chemotherapy , but accuracy did not differ significantly between the two groups . Thus , for patients who achieve complete axillary clearance by chemotherapy , SNB could replace AND PURPOSE To determine the detection rate , the false-negative rate , and the accuracy of sentinel lymph node ( SLN ) detection after neoadjuvant chemotherapy ( NAC ) for advanced breast cancer . PATIENTS AND METHODS A prospect i ve multicentric study was initiated to evaluate the results of SLN biopsy with the combined method after NAC for advanced large operable breast cancer . RESULTS From September 2003 to March 2007 , 195 patients enrolled from 12 institutions were found suitable for evaluation . The detection rate was 90 % ( 176 of 195 patients ) , and the false-negative rate was 11.5 % ( six of 52 patients ) . Patients without axillary palpable nodes ( N0 ) before NAC had a better detection rate compared with patients with axillary suspicious nodes ( N1 , 94.6 % v 81.5 % ; P = .008 ) . The false-negative rate was not correlated with clinical nodal status before NAC ( 9.4 % v 15 % ; P = .66 ) . CONCLUSION This study confirms the feasibility of SLN biopsy after NAC in the case of large operable breast cancer . The detection rate , false-negative rate , and accuracy do not differ from those obtained in the case of early breast cancer without NAC , thus demonstrating the feasibility of SLN biopsy after NAC Abstract Background : We evaluated the accuracy of sentinel lymph node dissection ( SLND ) in patients with stage II and III breast cancer who had received preoperative therapy . Methods : A prospect i ve clinical trial evaluated 122 patients who had SLND followed by axillary lymph node dissection . Thirty-two women had stage II or III breast cancer and received preoperative doxorubicin-based chemotherapy or paclitaxel and radiotherapy . Results : A sentinel lymph node ( SLN ) was identified in 31 ( 97 % ) of 32 patients . The SLN predicted the status of the axillary nodes in 30 ( 97 % ) of 31 patients . Eighteen ( 58 % ) of 31 had metastases in the SLN . Eighteen of 19 patients with axillary metastases had a tumor-positive SLN ( sensitivity , 95 % ; false-negative rate , 5 % ) . Eight ( 44 % ) of 18 women with metastases in the SLN also had metastases in 1 or more nonsentinel nodes . Conclusions : In this relatively small study , the accuracy of SLND in women with stage II or III breast cancer treated with preoperative therapy was similar to that achieved in early-stage breast cancer . If these results are confirmed in a larger cohort , it may be feasible to substitute SLND for routine axillary lymph node dissection in this population . This approach could reduce the morbidity of surgical therapy while preserving the accuracy of axillary staging and maintaining regional control in this high-risk population Abstract Background : Sentinel lymph node dissection ( SLND ) for small , early-stage breast cancer is well accepted . However , the role of SLND for large primary breast cancer is controversial . We investigated the feasibility and clinical applicability of SLND in patients with large ( ≥5 cm ) breast cancers and clinical ly negative axillae . Methods : A prospect ively entered data base was used to identify all patients who underwent surgical management of histopathologically confirmed primary breast carcinomas ≥5 cm in diameter between September 1991 and August 2000 . Patients who had clinical ly negative axillae and underwent SLND followed by completion axillary lymph node dissection ( ALND ) were selected for the study . The positivity rate , accuracy rate , and false-negative rate of SLND were determined . Results : Of the 41 patients selected for the study , 24 had infiltrating ductal carcinoma and 17 had infiltrating lobular carcinoma . Mean tumor size was 7.12 cm ( range , 5–23 cm ) . At least one sentinel lymph node ( SLN ) was identified in all cases . Thirty patients had tumor-positive SLNs . Axillary metastasis was also identified in one patient who did not have a positive SLN . Thus , SLN status accurately predicted regional nodal status in 98 % ( 40 of 41 ) of cases . The false-negative rate of SLND was 3 % ( 1 of 31 ) . None of the three patients with SLN micrometastasis , defined as a tumor focus ≤2 mm , had tumor deposits in nonsentinel axillary lymph nodes . Only SLN macrometastasis ( > 2-mm tumor deposit ) and primary tumor size ≥7 cm predicted nonsentinel axillary metastasis with significance on multivariate analysis ( P = .008 and P = .046 , respectively ) . Conclusions : SLND is feasible and accurate in patients with large breast cancers and clinical ly negative axillae . Axillary lymph node dissection can be avoided in nearly one third of patients by focused examination of the SLN Background : In a prospect i ve study , upper limb morbidity and perceived disability/activities of daily life ( ADLs ) were assessed before and 1 year after sentinel lymph node biopsy ( SLNB ) or axillary lymph node dissection ( ALND ) . Methods : A total of 204 patients with stage I/II breast cancer ( mean age , 55.6 years ; SD , 11.6 years ) entered the study , and 189 patients ( 93 % ) could be evaluated after 1 year . Fifty-eight patients ( 31 % ) underwent only SLNB , and 131 ( 69 % ) underwent ALND . Assessment s performed before surgery ( t0 ) and 1 year after surgery ( t1 ) , included pain , shoulder range of motion , muscle strength , upper arm/forearm circumference , and perceived shoulder disability/ADL . Results : Considerable treatment-related upper limb morbidity was observed . Significant ( P < .05 ) changes between t0 and t1 were found in all assessment s except strength of elbow flexors . Patients in the ALND group showed significantly more changes in the range of motion in forward flexion , abduction , and abduction/external rotation ; grip strength and strength of shoulder abductors ; circumference of upper arm and forearm ; and perceived shoulder disability in ADLs compared with the SLNB group . Multivariate linear regression analysis showed that ALND could predict a decrease of range of motion in forward flexion , abduction , strength of shoulder abductors , grip strength , and shoulder-related ADLs and an increase in the circumference of the upper arm . Radiation of the axilla ( 19 patients ) predicts an additional decrease in shoulder range of motion . Conclusions : One year after treatment of breast cancer , there is significantly less upper limb morbidity after SLNB compared with ALND . ALND is a predictor for upper limb morbidity The aim of this study was to analyse the accuracy of scintigraphic and gamma probe sentinel node ( SN ) localization in breast cancer patients who have been su bmi tted to neoadjuvant chemotherapy ( NC ) . Seventy-six patients with single breast cancer were included in the study , and were classified into two groups . Group 1 consisted of 40 women who had received NC , and Group 2 consisted of 36 women who did not receive NC . All patients received 111 MBq ( 3 mCi ) of 99Tcm-nanocolloid in 3 ml , by peritumoural injection . Anterior and lateral thoracic scans were obtained 2 h post-injection . The following day ( 18 - 24 h post-injection ) the patients underwent surgery and sentinel nodes were localized by using a gamma probe . Complete axillary lymph node dissection was performed in all patients . Histological analysis included haematoxylin-eosin in all cases and immunohistochemistry in 10 cases . In Group 1 , SNs were localized in 36/40 patients , histological analysis was performed in 34 and there were four false negatives ( 22 % ) . In Group 2 , SNs were localized in 32/36 patients , histological analysis was performed in 29 and there were two false negatives ( 9 % ) . Predictive negative values were 78 % and 90 % in Groups 1 and 2 , respectively . In summary , sentinel node localization in breast cancer patients su bmi tted to previous neoadjuvant chemotherapy is less accurate than in patients who do not receive this therapy . The procedure is not sufficiently accurate to localize the sentinel node , thus it can not be recommended in these patients PURPOSE To develop a guideline for the use of sentinel node biopsy ( SNB ) in early stage breast cancer . METHODS An American Society of Clinical Oncology ( ASCO ) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer . The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB . The guideline was review ed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors . RESULTS The literature review identified one published prospect i ve r and omized controlled trial in which SNB was compared with axillary lymph node dissection ( ALND ) , four limited meta-analyses , and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND ( completion axillary dissection ) . There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer . However , a review of the available evidence demonstrates that , when performed by experienced clinicians , SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes . CONCLUSION SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinical ly negative axillary nodes . Completion ALND remains st and ard treatment for patients with axillary metastases identified on SNB . Appropriately identified patients with negative results of SNB , when done under the direction of an experienced surgeon , need not have completion ALND . Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance . Although such specialized techniques are often used , they are not a required part of SLN evaluation for breast cancer at this time . Data suggest that SNB is associated with less morbidity than ALND , but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown Purpose : Sentinel node ( SN ) biopsy is a reliable method for improved staging of breast cancer , offering an alternative to routine axillary dissection . Perhaps preoperative chemotherapy could increase the rate of false‐negative SN because of induced lymphatic changes . The aim of the study was to evaluate the utility of lymphoscintigraphy and of h and ‐held probe detection in the SN approach after chemotherapy , correlating it with histologic analysis of the axilla . Methods : Eighty‐three patients ( mean age , 53 years ; TNM stage I ) were studied prospect ively . They were separated into two groups : group 1 ( G1 ) , 37 patients with preoperative chemotherapy and group 2 ( G2 ) , 46 patients without chemotherapy . Mean tumor size was 2 cm in both groups . Lymphoscintigraphy was performed 3 to 4 hours after peritumoral injection of Tc‐99 m dextran‐70 in a 0.2‐ml volume and activity of 14.8 MBq ( 0.4 mCi ) , performed under ultrasound or mammographic control . On the following day , each patient underwent tumor resection with axillary dissection , included the SN . Results : The SN was detected by scintigraphy in 78 patients ( 94 % ) . The failure of SN to predict the axillary histologic status was significantly higher ( P = 0.01 ) in G1 than in G2 ( 7 and 1 false‐negative result , respectively ) . Conclusion : Preoperative chemotherapy seems to impair axillary evaluation by SN biopsy and should be used cautiously in this subset of patients Objective : The aim of this multicenter r and omized trial was to assess the efficacy and safety of sentinel lymph node ( SLN ) biopsy compared with axillary lymph node dissection ( ALND ) . Background : All studies on SLN biopsy in breast cancer report a variable false negative rate , whose prognostic consequences are still unclear . Methods : From May \n Output:\n " }, { "from": "agent", "value": "The reported SN success rates were heterogeneous and several variables were reported to be associated with decreased SN accuracy , i.e. initially positive clinical nodal status .\nThere is a potential role for SN biopsy following NAC which could be considered on an individual basis .\nHowever , there is insufficient evidence to recommend this as a st and ard procedure ." } ]
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: Background The aim was to prove the low identification rate of sentinel lymph node biopsy ( SNB ) and to determine the feasibility of replacing axillary lymph node dissection ( AND ) in axillary lymph node positive patients after chemotherapy . Methods From October 2001 to July 2005 , 875 consecutive patients with primary operable breast cancer underwent SNB and AND . Among them , 238 received pre-operative chemotherapy . We compared the identification rate , false negative rate ( FNR ) , negative predictive value ( NPV ) , and accuracy of SNB in clinical ly node-positive patients with or without chemotherapy . Results The identification rate was significantly lower in patients received chemotherapy ( 77.6 % ) than in those not received it ( 97.0 % ) ( P < 0.001 ) . In those received the therapy , the FNR was 5.6 % , the NPV was 86.8 % , and the accuracy was 95.9 % . In those not received therapy , the FNR was 7.4 % and the accuracy was 92.6 % ( differences not statistically significant ) . Conclusion The identification rate in confirmed axillary lymph node-positive patients was significantly lower in patients received pre-operative chemotherapy , but accuracy did not differ significantly between the two groups . Thus , for patients who achieve complete axillary clearance by chemotherapy , SNB could replace AND PURPOSE To determine the detection rate , the false-negative rate , and the accuracy of sentinel lymph node ( SLN ) detection after neoadjuvant chemotherapy ( NAC ) for advanced breast cancer . PATIENTS AND METHODS A prospect i ve multicentric study was initiated to evaluate the results of SLN biopsy with the combined method after NAC for advanced large operable breast cancer . RESULTS From September 2003 to March 2007 , 195 patients enrolled from 12 institutions were found suitable for evaluation . The detection rate was 90 % ( 176 of 195 patients ) , and the false-negative rate was 11.5 % ( six of 52 patients ) . Patients without axillary palpable nodes ( N0 ) before NAC had a better detection rate compared with patients with axillary suspicious nodes ( N1 , 94.6 % v 81.5 % ; P = .008 ) . The false-negative rate was not correlated with clinical nodal status before NAC ( 9.4 % v 15 % ; P = .66 ) . CONCLUSION This study confirms the feasibility of SLN biopsy after NAC in the case of large operable breast cancer . The detection rate , false-negative rate , and accuracy do not differ from those obtained in the case of early breast cancer without NAC , thus demonstrating the feasibility of SLN biopsy after NAC Abstract Background : We evaluated the accuracy of sentinel lymph node dissection ( SLND ) in patients with stage II and III breast cancer who had received preoperative therapy . Methods : A prospect i ve clinical trial evaluated 122 patients who had SLND followed by axillary lymph node dissection . Thirty-two women had stage II or III breast cancer and received preoperative doxorubicin-based chemotherapy or paclitaxel and radiotherapy . Results : A sentinel lymph node ( SLN ) was identified in 31 ( 97 % ) of 32 patients . The SLN predicted the status of the axillary nodes in 30 ( 97 % ) of 31 patients . Eighteen ( 58 % ) of 31 had metastases in the SLN . Eighteen of 19 patients with axillary metastases had a tumor-positive SLN ( sensitivity , 95 % ; false-negative rate , 5 % ) . Eight ( 44 % ) of 18 women with metastases in the SLN also had metastases in 1 or more nonsentinel nodes . Conclusions : In this relatively small study , the accuracy of SLND in women with stage II or III breast cancer treated with preoperative therapy was similar to that achieved in early-stage breast cancer . If these results are confirmed in a larger cohort , it may be feasible to substitute SLND for routine axillary lymph node dissection in this population . This approach could reduce the morbidity of surgical therapy while preserving the accuracy of axillary staging and maintaining regional control in this high-risk population Abstract Background : Sentinel lymph node dissection ( SLND ) for small , early-stage breast cancer is well accepted . However , the role of SLND for large primary breast cancer is controversial . We investigated the feasibility and clinical applicability of SLND in patients with large ( ≥5 cm ) breast cancers and clinical ly negative axillae . Methods : A prospect ively entered data base was used to identify all patients who underwent surgical management of histopathologically confirmed primary breast carcinomas ≥5 cm in diameter between September 1991 and August 2000 . Patients who had clinical ly negative axillae and underwent SLND followed by completion axillary lymph node dissection ( ALND ) were selected for the study . The positivity rate , accuracy rate , and false-negative rate of SLND were determined . Results : Of the 41 patients selected for the study , 24 had infiltrating ductal carcinoma and 17 had infiltrating lobular carcinoma . Mean tumor size was 7.12 cm ( range , 5–23 cm ) . At least one sentinel lymph node ( SLN ) was identified in all cases . Thirty patients had tumor-positive SLNs . Axillary metastasis was also identified in one patient who did not have a positive SLN . Thus , SLN status accurately predicted regional nodal status in 98 % ( 40 of 41 ) of cases . The false-negative rate of SLND was 3 % ( 1 of 31 ) . None of the three patients with SLN micrometastasis , defined as a tumor focus ≤2 mm , had tumor deposits in nonsentinel axillary lymph nodes . Only SLN macrometastasis ( > 2-mm tumor deposit ) and primary tumor size ≥7 cm predicted nonsentinel axillary metastasis with significance on multivariate analysis ( P = .008 and P = .046 , respectively ) . Conclusions : SLND is feasible and accurate in patients with large breast cancers and clinical ly negative axillae . Axillary lymph node dissection can be avoided in nearly one third of patients by focused examination of the SLN Background : In a prospect i ve study , upper limb morbidity and perceived disability/activities of daily life ( ADLs ) were assessed before and 1 year after sentinel lymph node biopsy ( SLNB ) or axillary lymph node dissection ( ALND ) . Methods : A total of 204 patients with stage I/II breast cancer ( mean age , 55.6 years ; SD , 11.6 years ) entered the study , and 189 patients ( 93 % ) could be evaluated after 1 year . Fifty-eight patients ( 31 % ) underwent only SLNB , and 131 ( 69 % ) underwent ALND . Assessment s performed before surgery ( t0 ) and 1 year after surgery ( t1 ) , included pain , shoulder range of motion , muscle strength , upper arm/forearm circumference , and perceived shoulder disability/ADL . Results : Considerable treatment-related upper limb morbidity was observed . Significant ( P < .05 ) changes between t0 and t1 were found in all assessment s except strength of elbow flexors . Patients in the ALND group showed significantly more changes in the range of motion in forward flexion , abduction , and abduction/external rotation ; grip strength and strength of shoulder abductors ; circumference of upper arm and forearm ; and perceived shoulder disability in ADLs compared with the SLNB group . Multivariate linear regression analysis showed that ALND could predict a decrease of range of motion in forward flexion , abduction , strength of shoulder abductors , grip strength , and shoulder-related ADLs and an increase in the circumference of the upper arm . Radiation of the axilla ( 19 patients ) predicts an additional decrease in shoulder range of motion . Conclusions : One year after treatment of breast cancer , there is significantly less upper limb morbidity after SLNB compared with ALND . ALND is a predictor for upper limb morbidity The aim of this study was to analyse the accuracy of scintigraphic and gamma probe sentinel node ( SN ) localization in breast cancer patients who have been su bmi tted to neoadjuvant chemotherapy ( NC ) . Seventy-six patients with single breast cancer were included in the study , and were classified into two groups . Group 1 consisted of 40 women who had received NC , and Group 2 consisted of 36 women who did not receive NC . All patients received 111 MBq ( 3 mCi ) of 99Tcm-nanocolloid in 3 ml , by peritumoural injection . Anterior and lateral thoracic scans were obtained 2 h post-injection . The following day ( 18 - 24 h post-injection ) the patients underwent surgery and sentinel nodes were localized by using a gamma probe . Complete axillary lymph node dissection was performed in all patients . Histological analysis included haematoxylin-eosin in all cases and immunohistochemistry in 10 cases . In Group 1 , SNs were localized in 36/40 patients , histological analysis was performed in 34 and there were four false negatives ( 22 % ) . In Group 2 , SNs were localized in 32/36 patients , histological analysis was performed in 29 and there were two false negatives ( 9 % ) . Predictive negative values were 78 % and 90 % in Groups 1 and 2 , respectively . In summary , sentinel node localization in breast cancer patients su bmi tted to previous neoadjuvant chemotherapy is less accurate than in patients who do not receive this therapy . The procedure is not sufficiently accurate to localize the sentinel node , thus it can not be recommended in these patients PURPOSE To develop a guideline for the use of sentinel node biopsy ( SNB ) in early stage breast cancer . METHODS An American Society of Clinical Oncology ( ASCO ) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer . The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB . The guideline was review ed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors . RESULTS The literature review identified one published prospect i ve r and omized controlled trial in which SNB was compared with axillary lymph node dissection ( ALND ) , four limited meta-analyses , and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND ( completion axillary dissection ) . There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer . However , a review of the available evidence demonstrates that , when performed by experienced clinicians , SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes . CONCLUSION SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinical ly negative axillary nodes . Completion ALND remains st and ard treatment for patients with axillary metastases identified on SNB . Appropriately identified patients with negative results of SNB , when done under the direction of an experienced surgeon , need not have completion ALND . Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance . Although such specialized techniques are often used , they are not a required part of SLN evaluation for breast cancer at this time . Data suggest that SNB is associated with less morbidity than ALND , but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown Purpose : Sentinel node ( SN ) biopsy is a reliable method for improved staging of breast cancer , offering an alternative to routine axillary dissection . Perhaps preoperative chemotherapy could increase the rate of false‐negative SN because of induced lymphatic changes . The aim of the study was to evaluate the utility of lymphoscintigraphy and of h and ‐held probe detection in the SN approach after chemotherapy , correlating it with histologic analysis of the axilla . Methods : Eighty‐three patients ( mean age , 53 years ; TNM stage I ) were studied prospect ively . They were separated into two groups : group 1 ( G1 ) , 37 patients with preoperative chemotherapy and group 2 ( G2 ) , 46 patients without chemotherapy . Mean tumor size was 2 cm in both groups . Lymphoscintigraphy was performed 3 to 4 hours after peritumoral injection of Tc‐99 m dextran‐70 in a 0.2‐ml volume and activity of 14.8 MBq ( 0.4 mCi ) , performed under ultrasound or mammographic control . On the following day , each patient underwent tumor resection with axillary dissection , included the SN . Results : The SN was detected by scintigraphy in 78 patients ( 94 % ) . The failure of SN to predict the axillary histologic status was significantly higher ( P = 0.01 ) in G1 than in G2 ( 7 and 1 false‐negative result , respectively ) . Conclusion : Preoperative chemotherapy seems to impair axillary evaluation by SN biopsy and should be used cautiously in this subset of patients Objective : The aim of this multicenter r and omized trial was to assess the efficacy and safety of sentinel lymph node ( SLN ) biopsy compared with axillary lymph node dissection ( ALND ) . Background : All studies on SLN biopsy in breast cancer report a variable false negative rate , whose prognostic consequences are still unclear . Methods : From May Output:
MS27702
[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: BACKGROUND Disease management programs ( DMPs ) that use multidisciplinary teams and specialized clinics reduce hospital admissions and improve quality of life and functional status . Evaluations of cardiac DMPs delivered by home health nurses are required . METHODS Between August 1999 and August 2000 we identified consecutive patients admitted to hospital with elevated cardiac enzymes . Patients who agreed were r and omly assigned to participate in a DMP or to receive usual care . The DMP included 6 home visits by a cardiac-trained nurse , a st and ardized nurses ' checklist , referral criteria for specialty care , communication with the family physician and patient education . We measured readmission days per 1000 follow-up days for angina , congestive heart failure ( CHF ) and chronic obstructive pulmonary disease ( COPD ) ; all-cause readmission days ; and provincial cl aims for emergency department visits , physician visits , diagnostic or therapeutic services and laboratory services . RESULTS We screened 715 consecutive patients admitted with elevated cardiac markers between August 1999 and August 2000 . Of those screened 71 DMP and 75 usual care patients met the diagnostic criteria for myocardial infa rct ion , were eligible for visits from a home health nurse and consented to participate in the study . Readmission days for angina , CHF and COPD per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( incidence density ratio [ IDR ] = 1.59 , 95 % confidence interval [ CI ] 1.27 - 2.00 , p < 0.001 ) . All-cause readmission days per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( IDR = 1.53 , 95 % CI 1.37 - 1.71 , p < 0.001 ) . The difference in emergency department encounters per 1000 follow-up days was significant ( IDR = 2.08 , 95 % CI 1.56 - 2.77 , p < 0.001 ) . During the first 25 days after discharge , there were significantly fewer provincial cl aims su bmi tted for DMP patients than for usual care patients for emergency department visits ( p = 0.007 ) , diagnostic or therapeutic services ( p = 0.012 ) and laboratory services ( p = 0.007 ) . INTERPRETATION The results provide evidence that an appropriately developed and implemented community-based inner-city DMP delivered by home health nurses has a positive impact on patient outcomes Prehospital delay is a major problem in the management of patients with acute cardiac ischemia . The authors created a patient teaching program consisting of an educational video and written instructions design ed to reduce prehospital delays in patients with chest pain . Patients who received st and ard discharge instructions served as the control group , whereas those who received the new patient teaching in addition to st and ard discharge instructions served as the intervention group . Of the 500 enrolled , 19 % were rehospitalized within 1 year . Analysis of rehospitalizations showed no significant difference between the two groups on the three outcome variables : percentage who presented within the first hour of pain , use of ambulance , and time from anginal onset to emergency department arrival . In a comparison of the index hospitalization to the rehospitalization , there was a significant increase in the use of ambulances for the intervention group , p = .03 , but not for the control group For this study a r and omized clinical trial was design ed to test the effects of an early home recovery information intervention on physical functioning , psychological distress , and symptom frequency 1 month following coronary artery bypass graft surgery ( CABG ) . Recovery outcomes were compared between two groups : those receiving an audiotape of information on expected physical sensations and their management ( Cardiac Home Information Program [ CHIP ] ) in addition to the usual care , and those receiving the usual cardiac discharge information protocol . A nonprobability sample of 180 patients ( 84 women and 96 men ; mean age = 62 years ) was equally distributed between the two study groups . When controlling for age , comorbidity , and cardiac functional status , the results showed positive effects on physical functioning in women and psychological distress , vigor and fatigue in men . Consistent with other studies , women had worse physical functioning and more symptom frequency than men . These findings indicate that the CHIP intervention is an effective method to prepare CABG patients for home recovery A study of a r and om sample of hospitals in Engl and that provide information leaflets for women undergoing hysterectomy indicates a large variation in quality . In general , the findings reveal that written information for patients is given a relatively low priority . Production and dissemination of information for hysterectomy patients is somewhat ad hoc . It is not clear that any evaluation of the leaflets has been conducted to prove the efficacy of the available literature . While the majority of leaflets include information deemed essential by past hysterectomy patients , the presentation of the recovery process often implies no control for the patient , and conceives normality with a narrow perspective about what healthy behaviour means for women . The provision of a specific timetable for resumption of housework duties in 65 % of the leaflets is a case in point . On the basis of the results of the survey , recommendations are made concerning the improvement of the st and ard of patient information leaflets The purpose of this study was to investigate the impact of a supportive-educative telephone program on the levels of knowledge and anxiety of patients undergoing coronary artery bypass graft surgery during the first 6 weeks after hospital discharge . With a posttest-only control group design , the first 74 patients scheduled , between September 1986 and February 1987 , for coronary artery bypass graft surgery in a large , western Canadian teaching hospital were r and omly assigned to either an experimental or a control group . The effect of the intervention , which was implemented by a cardiac rehabilitation nurse specialist , was assessed by a knowledge test and a state anxiety inventory . Data were collected without knowledge of the participants ' group assignment . As hypothesized , data analysis with independent t tests revealed a statistically significant ( p less than 0.05 ) difference between the knowledge level of the experimental and the control group in the areas of coronary artery disease , diet , medications , physical activity restrictions , exercise , and rest . A statistically significant difference between the state anxiety level of the experimental and the control group was also evident , as was a statistically significant inverse relationship between participants ' knowledge and anxiety levels . From these findings , several implication s and recommendations for nursing practice and research have been generated BACKGROUND This study evaluated the relative effects on compliance with recommended lifestyle changes of two experimental videotapes that involved different approaches for preparing coronary artery bypass graft ( CABG ) patients for the posthospital recovery period . The tapes differed in the extent to which they portrayed the recovery period as a steady , forward progression versus a series of \" ups and downs . \" METHODS Two hundred sixteen male and female CABG patients were assigned r and omly either to view one of the two videotapes before discharge from the hospital or to receive only the st and ard discharge preparation provided by the hospital . All patients completed measures of anxiety and self-efficacy at discharge , 1 month and 3 months after discharge from the hospital . Patients also completed measures of dietary fat consumption and activity level 1 and 3 months after discharge . RESULTS Relative to controls , patients who viewed either of the videotapes before hospital release reported higher self-efficacy for adhering to the recommended low-fat diet both at discharge and 1 month after surgery . Viewing either of the videotapes also result ed in significantly less dietary fat intake 1 month after hospital release compared with controls . Patients who viewed the tape that portrayed the recovery period as consisting of ups and downs also reported significantly more frequent moderate exercise at 1 month and more frequent strenuous exercise 3 months after discharge . CONCLUSIONS The experimental videotapes proved to be an effective method for increasing dietary and exercise compliance during the first 3 months after CABG Shortened hospitalizations following cardiac surgery necessitate re-evaluation of how pertinent information for self-care management and reduction of coronary artery disease risk factors can be incorporated into an effective inpatient cardiac patient teaching program . This study investigated the effect of three different teaching approaches ( i.e. , an inpatient teaching program , a postdischarge telephone follow-up program , and a postdischarge group teaching program ) among 90 patients who had undergone coronary artery bypass graft surgery . Teaching outcomes were evaluated in this study by use of the Heart Disease Management Question naire and Cardiac Surgical Patient Teaching Satisfaction Inventory . Analyses of the data revealed similar patient teaching outcomes regardless of the type of teaching intervention the participant received . Findings supported the effectiveness of the inpatient teaching protocol which focused on \" survival skills \" for self-care management postdischarge . The findings are important in the re design of teaching programs which are efficient yet meaningful to the patient within today 's health care environment . Additional findings indicated that patients who had longer lengths of stay and those with more vessels bypassed were the least satisfied with their teaching . Further implication s for nurses involved in patient teaching are discussed The impact of patient education follow-up by telephone on the knowledge of the postmyocardial infa rct ion ( MI ) patient was investigated in this study . On the basis of Orem 's self-care framework , subjects ' levels of knowledge in six criterion areas were assessed according to measurement criteria developed by Horn and Swain . Fifty-one subjects from the total population of MI patients admitted to the coronary care unit of the study hospital during the period of research who met study criteria were r and omly assigned to experimental and control groups . Statistically significant differences ( p less than 0.05 ) were found in the knowledge level of the experimental group in the areas of the disease , its effects , related self-care measures , recommended exercises , and all teaching areas together . Although significant differences were not found in the teaching areas of therapeutic diet , medications , physical activity restrictions , and recommended rest , a higher mean was produced for the experimental group in all but one area . These findings demonstrate that a telephone teaching program for MI patients 6 to 8 weeks after hospital discharge can be effective in increasing knowledge relative to the disease , self-care , and therapeutic regimen PURPOSE Patients who have undergone coronary artery bypass graft surgery ( CABG ) are obvious c and i date s for rehabilitation programs because of the potential for progression of disease . Such programs have been shown to foster risk-factor modification , improve quality of life , and prolong survival among post-myocardial infa rct ion ( MI ) patients . However , the efficacy of these programs has not been established among patients who have undergone CABG . METHODS A r and omized controlled trial was employed to evaluate whether a behavioral and educational cardiac rehabilitation program was effective in modifying cardiovascular disease risk factors and improving quality of life in a cohort of 86 patients after CABG . Patients were recruited from the cardiac ward of a large teaching hospital and were block-r and omized to either an intervention group or routine care . Subjects in the intervention group attended 6 weekly group sessions following hospital discharge , and booster sessions at 8 months and 1 year . They also received a personalized behavior modification program based on their baseline risk factors . Risk factor and quality of life measures were recorded at baseline ( 6 weeks after surgery ) , 4 months , 8 months , and 1 year . RESULTS The results indicated few differences between the study groups . However , the intervention group 's aerobic capacity ( VO2max ) improved over that of the routine care group . With regard to the quality of life variables , all patients tended to improve steadily over time . CONCLUSIONS The relatively moderate success of this intervention program compared with various post-MI studies may be indicative of differences between the treatment needs of patients after acute myocardial infa rct ion or CABG . Future post-CABG rehabilitation research should explore these patients ' unique treatment needs , and investigate a variety of program strategies The purpose of this study was to investigate primary nursing , discharge teaching and patient satisfaction in a group of ambulatory cataract patients . A sample ( n = 72 ) of subjects was divided r and omly into a primary group ( n = 36 ) and a control group ( n = 36 ) . Data on patient knowledge and satisfaction was collected by telephone 24 - 48 hours after surgery . Knowledge levels were high , and there was no significant difference between the primary and control groups in total score or in sub-scores on self-care , normal side effects , or complications . Women had significantly higher total scores than men ( p > .05 ) . There was a very high level of satisfaction with care , and almost all patients felt ready to go home when discharged OBJECTIVE To establish whether the provision of commercially produced written information in addition to routine hospital information can improve patients ' knowledge and satisfaction and affect their health-related quality of life . METHODS Elective surgical patients were r and omised into an experimental group ( N = 54 ) who received three commercially produced information booklets at pre- assessment , before surgery and at discharge , and a control group ( N = 55 ) who received st and ard hospital information only . RESULTS The experimental group were significantly less anxious immediately before their operation , and reported greater perceived control compared to controls post-operatively . Two weeks after discharge , health status for the two groups was similar except the experimental group reported significantly less pain . Overall satisfaction was fairly high and similar in both groups . The experimental group demonstrated greater knowledge at pre-admission , but not at discharge or follow-up . DISCUSSION Patients increasingly expect written information ; however amount , quality and timeliness vary considerably . Combining commercially produced information with st and ard hospital information may be to the patient 's benefit . PRACTICE IMPLICATION S Providing patients with commercially produced st and ardised information in addition to internally produced hospital information could have an additional , though limited , benefit to patients ' health outcomes . This could be a way of incorporating the expertise of both providers to the patient 's benefit OBJECTIVE To examine functional status outcomes among patients with a coronary artery bypass graft ( CABG ) over time ( ie , at baseline ; 3 months , 6 \n Output:\n " }, { "from": "agent", "value": "Major results : Findings indicate that delivery of postoperative patient education through the individualization of content , use of combined media for delivery , provision of education on a one-on-one basis , and in multiple sessions is associated with improvement in educational/health outcomes ." } ]
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: BACKGROUND Disease management programs ( DMPs ) that use multidisciplinary teams and specialized clinics reduce hospital admissions and improve quality of life and functional status . Evaluations of cardiac DMPs delivered by home health nurses are required . METHODS Between August 1999 and August 2000 we identified consecutive patients admitted to hospital with elevated cardiac enzymes . Patients who agreed were r and omly assigned to participate in a DMP or to receive usual care . The DMP included 6 home visits by a cardiac-trained nurse , a st and ardized nurses ' checklist , referral criteria for specialty care , communication with the family physician and patient education . We measured readmission days per 1000 follow-up days for angina , congestive heart failure ( CHF ) and chronic obstructive pulmonary disease ( COPD ) ; all-cause readmission days ; and provincial cl aims for emergency department visits , physician visits , diagnostic or therapeutic services and laboratory services . RESULTS We screened 715 consecutive patients admitted with elevated cardiac markers between August 1999 and August 2000 . Of those screened 71 DMP and 75 usual care patients met the diagnostic criteria for myocardial infa rct ion , were eligible for visits from a home health nurse and consented to participate in the study . Readmission days for angina , CHF and COPD per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( incidence density ratio [ IDR ] = 1.59 , 95 % confidence interval [ CI ] 1.27 - 2.00 , p < 0.001 ) . All-cause readmission days per 1000 follow-up days were significantly higher for usual care patients than for DMP patients ( IDR = 1.53 , 95 % CI 1.37 - 1.71 , p < 0.001 ) . The difference in emergency department encounters per 1000 follow-up days was significant ( IDR = 2.08 , 95 % CI 1.56 - 2.77 , p < 0.001 ) . During the first 25 days after discharge , there were significantly fewer provincial cl aims su bmi tted for DMP patients than for usual care patients for emergency department visits ( p = 0.007 ) , diagnostic or therapeutic services ( p = 0.012 ) and laboratory services ( p = 0.007 ) . INTERPRETATION The results provide evidence that an appropriately developed and implemented community-based inner-city DMP delivered by home health nurses has a positive impact on patient outcomes Prehospital delay is a major problem in the management of patients with acute cardiac ischemia . The authors created a patient teaching program consisting of an educational video and written instructions design ed to reduce prehospital delays in patients with chest pain . Patients who received st and ard discharge instructions served as the control group , whereas those who received the new patient teaching in addition to st and ard discharge instructions served as the intervention group . Of the 500 enrolled , 19 % were rehospitalized within 1 year . Analysis of rehospitalizations showed no significant difference between the two groups on the three outcome variables : percentage who presented within the first hour of pain , use of ambulance , and time from anginal onset to emergency department arrival . In a comparison of the index hospitalization to the rehospitalization , there was a significant increase in the use of ambulances for the intervention group , p = .03 , but not for the control group For this study a r and omized clinical trial was design ed to test the effects of an early home recovery information intervention on physical functioning , psychological distress , and symptom frequency 1 month following coronary artery bypass graft surgery ( CABG ) . Recovery outcomes were compared between two groups : those receiving an audiotape of information on expected physical sensations and their management ( Cardiac Home Information Program [ CHIP ] ) in addition to the usual care , and those receiving the usual cardiac discharge information protocol . A nonprobability sample of 180 patients ( 84 women and 96 men ; mean age = 62 years ) was equally distributed between the two study groups . When controlling for age , comorbidity , and cardiac functional status , the results showed positive effects on physical functioning in women and psychological distress , vigor and fatigue in men . Consistent with other studies , women had worse physical functioning and more symptom frequency than men . These findings indicate that the CHIP intervention is an effective method to prepare CABG patients for home recovery A study of a r and om sample of hospitals in Engl and that provide information leaflets for women undergoing hysterectomy indicates a large variation in quality . In general , the findings reveal that written information for patients is given a relatively low priority . Production and dissemination of information for hysterectomy patients is somewhat ad hoc . It is not clear that any evaluation of the leaflets has been conducted to prove the efficacy of the available literature . While the majority of leaflets include information deemed essential by past hysterectomy patients , the presentation of the recovery process often implies no control for the patient , and conceives normality with a narrow perspective about what healthy behaviour means for women . The provision of a specific timetable for resumption of housework duties in 65 % of the leaflets is a case in point . On the basis of the results of the survey , recommendations are made concerning the improvement of the st and ard of patient information leaflets The purpose of this study was to investigate the impact of a supportive-educative telephone program on the levels of knowledge and anxiety of patients undergoing coronary artery bypass graft surgery during the first 6 weeks after hospital discharge . With a posttest-only control group design , the first 74 patients scheduled , between September 1986 and February 1987 , for coronary artery bypass graft surgery in a large , western Canadian teaching hospital were r and omly assigned to either an experimental or a control group . The effect of the intervention , which was implemented by a cardiac rehabilitation nurse specialist , was assessed by a knowledge test and a state anxiety inventory . Data were collected without knowledge of the participants ' group assignment . As hypothesized , data analysis with independent t tests revealed a statistically significant ( p less than 0.05 ) difference between the knowledge level of the experimental and the control group in the areas of coronary artery disease , diet , medications , physical activity restrictions , exercise , and rest . A statistically significant difference between the state anxiety level of the experimental and the control group was also evident , as was a statistically significant inverse relationship between participants ' knowledge and anxiety levels . From these findings , several implication s and recommendations for nursing practice and research have been generated BACKGROUND This study evaluated the relative effects on compliance with recommended lifestyle changes of two experimental videotapes that involved different approaches for preparing coronary artery bypass graft ( CABG ) patients for the posthospital recovery period . The tapes differed in the extent to which they portrayed the recovery period as a steady , forward progression versus a series of " ups and downs . " METHODS Two hundred sixteen male and female CABG patients were assigned r and omly either to view one of the two videotapes before discharge from the hospital or to receive only the st and ard discharge preparation provided by the hospital . All patients completed measures of anxiety and self-efficacy at discharge , 1 month and 3 months after discharge from the hospital . Patients also completed measures of dietary fat consumption and activity level 1 and 3 months after discharge . RESULTS Relative to controls , patients who viewed either of the videotapes before hospital release reported higher self-efficacy for adhering to the recommended low-fat diet both at discharge and 1 month after surgery . Viewing either of the videotapes also result ed in significantly less dietary fat intake 1 month after hospital release compared with controls . Patients who viewed the tape that portrayed the recovery period as consisting of ups and downs also reported significantly more frequent moderate exercise at 1 month and more frequent strenuous exercise 3 months after discharge . CONCLUSIONS The experimental videotapes proved to be an effective method for increasing dietary and exercise compliance during the first 3 months after CABG Shortened hospitalizations following cardiac surgery necessitate re-evaluation of how pertinent information for self-care management and reduction of coronary artery disease risk factors can be incorporated into an effective inpatient cardiac patient teaching program . This study investigated the effect of three different teaching approaches ( i.e. , an inpatient teaching program , a postdischarge telephone follow-up program , and a postdischarge group teaching program ) among 90 patients who had undergone coronary artery bypass graft surgery . Teaching outcomes were evaluated in this study by use of the Heart Disease Management Question naire and Cardiac Surgical Patient Teaching Satisfaction Inventory . Analyses of the data revealed similar patient teaching outcomes regardless of the type of teaching intervention the participant received . Findings supported the effectiveness of the inpatient teaching protocol which focused on " survival skills " for self-care management postdischarge . The findings are important in the re design of teaching programs which are efficient yet meaningful to the patient within today 's health care environment . Additional findings indicated that patients who had longer lengths of stay and those with more vessels bypassed were the least satisfied with their teaching . Further implication s for nurses involved in patient teaching are discussed The impact of patient education follow-up by telephone on the knowledge of the postmyocardial infa rct ion ( MI ) patient was investigated in this study . On the basis of Orem 's self-care framework , subjects ' levels of knowledge in six criterion areas were assessed according to measurement criteria developed by Horn and Swain . Fifty-one subjects from the total population of MI patients admitted to the coronary care unit of the study hospital during the period of research who met study criteria were r and omly assigned to experimental and control groups . Statistically significant differences ( p less than 0.05 ) were found in the knowledge level of the experimental group in the areas of the disease , its effects , related self-care measures , recommended exercises , and all teaching areas together . Although significant differences were not found in the teaching areas of therapeutic diet , medications , physical activity restrictions , and recommended rest , a higher mean was produced for the experimental group in all but one area . These findings demonstrate that a telephone teaching program for MI patients 6 to 8 weeks after hospital discharge can be effective in increasing knowledge relative to the disease , self-care , and therapeutic regimen PURPOSE Patients who have undergone coronary artery bypass graft surgery ( CABG ) are obvious c and i date s for rehabilitation programs because of the potential for progression of disease . Such programs have been shown to foster risk-factor modification , improve quality of life , and prolong survival among post-myocardial infa rct ion ( MI ) patients . However , the efficacy of these programs has not been established among patients who have undergone CABG . METHODS A r and omized controlled trial was employed to evaluate whether a behavioral and educational cardiac rehabilitation program was effective in modifying cardiovascular disease risk factors and improving quality of life in a cohort of 86 patients after CABG . Patients were recruited from the cardiac ward of a large teaching hospital and were block-r and omized to either an intervention group or routine care . Subjects in the intervention group attended 6 weekly group sessions following hospital discharge , and booster sessions at 8 months and 1 year . They also received a personalized behavior modification program based on their baseline risk factors . Risk factor and quality of life measures were recorded at baseline ( 6 weeks after surgery ) , 4 months , 8 months , and 1 year . RESULTS The results indicated few differences between the study groups . However , the intervention group 's aerobic capacity ( VO2max ) improved over that of the routine care group . With regard to the quality of life variables , all patients tended to improve steadily over time . CONCLUSIONS The relatively moderate success of this intervention program compared with various post-MI studies may be indicative of differences between the treatment needs of patients after acute myocardial infa rct ion or CABG . Future post-CABG rehabilitation research should explore these patients ' unique treatment needs , and investigate a variety of program strategies The purpose of this study was to investigate primary nursing , discharge teaching and patient satisfaction in a group of ambulatory cataract patients . A sample ( n = 72 ) of subjects was divided r and omly into a primary group ( n = 36 ) and a control group ( n = 36 ) . Data on patient knowledge and satisfaction was collected by telephone 24 - 48 hours after surgery . Knowledge levels were high , and there was no significant difference between the primary and control groups in total score or in sub-scores on self-care , normal side effects , or complications . Women had significantly higher total scores than men ( p > .05 ) . There was a very high level of satisfaction with care , and almost all patients felt ready to go home when discharged OBJECTIVE To establish whether the provision of commercially produced written information in addition to routine hospital information can improve patients ' knowledge and satisfaction and affect their health-related quality of life . METHODS Elective surgical patients were r and omised into an experimental group ( N = 54 ) who received three commercially produced information booklets at pre- assessment , before surgery and at discharge , and a control group ( N = 55 ) who received st and ard hospital information only . RESULTS The experimental group were significantly less anxious immediately before their operation , and reported greater perceived control compared to controls post-operatively . Two weeks after discharge , health status for the two groups was similar except the experimental group reported significantly less pain . Overall satisfaction was fairly high and similar in both groups . The experimental group demonstrated greater knowledge at pre-admission , but not at discharge or follow-up . DISCUSSION Patients increasingly expect written information ; however amount , quality and timeliness vary considerably . Combining commercially produced information with st and ard hospital information may be to the patient 's benefit . PRACTICE IMPLICATION S Providing patients with commercially produced st and ardised information in addition to internally produced hospital information could have an additional , though limited , benefit to patients ' health outcomes . This could be a way of incorporating the expertise of both providers to the patient 's benefit OBJECTIVE To examine functional status outcomes among patients with a coronary artery bypass graft ( CABG ) over time ( ie , at baseline ; 3 months , 6 Output:
MS24828
[ { "from": "human", "value": "***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*** the input is a biomedical literature \n ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences \n ***DOCUMENTATION*** \n ***EXAMPLES*** \n Input: CONTEXT Three fourths of US men older than 50 years have been screened with prostate-specific antigen ( PSA ) for prostate cancer . OBJECTIVE To estimate the receiver operating characteristic ( ROC ) curve for PSA . DESIGN , SETTING , AND PARTICIPANTS Calculation of PSA ROC curves in the placebo group of the Prostate Cancer Prevention Trial , a r and omized , prospect i ve study conducted from 1993 to 2003 at 221 US centers . Participants were 18 882 healthy men aged 55 years or older without prostate cancer and with PSA levels less than or equal to 3.0 ng/mL and normal digital rectal examination results , followed up for 7 years with annual PSA measurement and digital rectal examination . If PSA level exceeded 4.0 ng/mL or rectal examination result was abnormal , a prostate biopsy was recommended . After 7 years of study participation , an end-of- study prostate biopsy was recommended in all cancer-free men . MAIN OUTCOME MEASURES Operating characteristics of PSA for prostate cancer detection , including sensitivity , specificity , and ROC curve . RESULTS Of 8575 men in the placebo group with at least 1 PSA measurement and digital rectal examination in the same year , 5587 ( 65.2 % ) had had at least 1 biopsy ; of these , 1225 ( 21.9 % ) were diagnosed with prostate cancer . Of 1213 cancers with Gleason grade recorded , 250 ( 20.6 % ) were Gleason grade 7 or greater and 57 ( 4.7 % ) were Gleason grade 8 or greater . The areas under the ROC curve ( AUC ) for PSA to discriminate any prostate cancer vs no cancer , Gleason grade 7 or greater cancer vs no or lower- grade cancer , and Gleason grade 8 or greater cancer vs no or lower- grade cancer were 0.678 ( 95 % confidence interval [ CI ] , 0.666 - 0.689 ) , 0.782 ( 95 % CI , 0.748 - 0.816 ) , and 0.827 ( 95 % CI , 0.761 - 0.893 ) , respectively ( all P values < .001 for AUC vs 50 % ) . For detecting any prostate cancer , PSA cutoff values of 1.1 , 2.1 , 3.1 , and 4.1 ng/mL yielded sensitivities of 83.4 % , 52.6 % , 32.2 % , and 20.5 % , and specificities of 38.9 % , 72.5 % , 86.7 % , and 93.8 % , respectively . Age-stratified analyses showed slightly better performance of PSA in men younger than 70 years vs those 70 years or older with AUC values of 0.699 ( SD , 0.013 ) vs 0.663 ( SD , 0.013 ) ( P = .03 ) . CONCLUSION There is no cutpoint of PSA with simultaneous high sensitivity and high specificity for monitoring healthy men for prostate cancer , but rather a continuum of prostate cancer risk at all values of PSA BACKGROUND Although the first laparoscopic radical prostatectomy was performed in 1997 , few midterm oncologic data have been published for the extraperitoneal procedure . OBJECTIVE To determine the oncologic outcome of extraperitoneal laparoscopic radical prostatectomy ( ELRP ) . DESIGN , SETTING , AND PARTICIPANTS From 2000 to 2007 , 1115 consecutive patients underwent ELRP for a localized prostate cancer at our department . Follow-up was scheduled and st and ardized for all patients and recorded into a prospect i ve data base . Median postoperative follow-up was 35.6 mo . INTERVENTION All ELRP were performed by three surgeons at the Department of Urology , Hospital Henri Mondor , Créteil , France . MEASUREMENTS Biochemical recurrence was defined by prostate-specific antigen level > or = 0.2 ng/ml . RESULTS AND LIMITATIONS In pN0/pNx cancers , postoperative stage was pT2 in 664 patients ( 59.5 % ) , pT3 in 350 patients ( 31.4 % ) , and pT4 in 77 patients ( 6.9 % ) . Positive lymph nodes were reported in 24 patients ( 2.2 % ) . Margins were positive in 16.1 % and 34.6 % of pT2 and pT3 cancers , respectively . Final Gleason score was < 7 in 288 men ( 25.8 % ) , = 7 in 701 men ( 62.9 % ) , and > 7 in 126 men ( 11.3 % ) . Overall prostate-specific antigen ( PSA ) recurrence-free survival was 83 % at 5 yr . The 5-yr progression-free survival rates were 93.4 % for pT2 , 74.5 % for pT3a , and 55.0 % for pT3b tumors , respectively . Multivariate Cox model showed that PSA , Gleason score , pT category , nodal status , and surgical margins were significant independent predictors of biochemical recurrence-free survival . CONCLUSIONS This assessment of oncologic results demonstrates that ELRP is a safe and effective procedure . On the basis of midterm follow-up data , the prognostic factors of PSA after ELRP failure are the same as those described previously in transperitoneal or open retropubic approaches . The oncologic results of ELRP also are in line with those reported with the use of the retropubic or the transperitoneal laparoscopic approaches PURPOSE To prospect ively evaluate multiparametric magnetic resonance imaging ( MRI ) for accurate localization of intraprostatic tumor nodules , with whole-mount histopathology as the gold st and ard . MATERIAL S AND METHODS Seventy-five patients with biopsy-proven , intermediate , and high-risk prostate cancer underwent preoperative T2-weighted ( T2w ) , dynamic contrast-enhanced ( DCE ) and diffusion-weighted ( DW ) MRI at 1.5 T . Localization of suspicious lesions was recorded for each of 24 st and ardized regions of interest on the different MR images and correlated with the pathologic findings . Generalized estimating equations ( GEE ) were used to estimate the sensitivity , specificity , accuracy , positive , and negative predictive value for every MRI modality , as well as to evaluate the influence of Gleason score and pT-stage . Tumor volume measurements on histopathological specimens were correlated with those on the different MR modalities ( Pearson correlation ) . RESULTS DW MRI had the highest sensitivity for tumor localization ( 31.1 % vs. 27.4 % vs. 44.5 % for T2w , DCE , and DW MRI , respectively ; P < 0.005 ) , with more aggressive or more advanced tumors being more easily detected with this imaging modality . Significantly higher sensitivity values were obtained for the combination of T2w , DCE , and DW MRI ( 58.8 % ) as compared to each modality alone or any combination of two modalities ( P < 0.0001 ) . Tumor volume can most accurately be assessed by means of DW MRI ( r = 0.75 ; P < 0.0001 ) . CONCLUSION Combining T2w , DCE , and DW imaging significantly improves prostate cancer localization PURPOSE The biology of prostate cancer may be influenced by the index lesion . The definition of index lesion volume is important for appropriate decision making , especially for image guided focal treatment . We determined the accuracy of magnetic resonance imaging for determining index tumor volume compared with volumes derived from histopathology . MATERIAL S AND METHODS We evaluated 135 patients ( mean age 59.3 years ) with a mean prostate specific antigen of 6.74 ng/dl who underwent multiparametric 3 T endorectal coil magnetic resonance imaging of the prostate and subsequent radical prostatectomy . Index tumor volume was determined prospect ively and independently by magnetic resonance imaging and histopathology . The ellipsoid formula was applied to determine histopathology tumor volume , whereas manual tumor segmentation was used to determine magnetic resonance tumor volume . Histopathology tumor volume was correlated with age and prostate specific antigen whereas magnetic resonance tumor volume involved Pearson correlation and linear regression methods . In addition , the predictive power of magnetic resonance tumor volume , prostate specific antigen and age for estimating histopathology tumor volume ( greater than 0.5 cm(3 ) ) was assessed by ROC analysis . The same analysis was also conducted for the 1.15 shrinkage factor corrected histopathology data set . RESULTS There was a positive correlation between histopathology tumor volume and magnetic resonance tumor volume ( Pearson coefficient 0.633 , p < 0.0001 ) , but a weak correlation between prostate specific antigen and histopathology tumor volume ( Pearson coefficient 0.237 , p = 0.003 ) . On linear regression analysis histopathology tumor volume and magnetic resonance tumor volume were correlated ( r(2 ) = 0.401 , p < 0.00001 ) . On ROC analysis AUC values for magnetic resonance tumor volume , prostate specific antigen and age in estimating tumors larger than 0.5 cm(3 ) at histopathology were 0.949 ( p < 0.0000001 ) , 0.685 ( p = 0.001 ) and 0.627 ( p = 0.02 ) , respectively . Similar results were found in the analysis with shrinkage factor corrected tumor volumes at histopathology . CONCLUSIONS Magnetic resonance imaging can accurately estimate index tumor volume as determined by histology . Magnetic resonance imaging has better accuracy in predicting histopathology tumor volume in tumors larger than 0.5 cm(3 ) than prostate specific antigen and age . Index tumor volume as determined by magnetic resonance imaging may be helpful in planning treatment , specifically in identifying tumor margins for image guided focal therapy and possibly selecting better active surveillance c and i date A variety of malignant neoplasms have been shown to induce capillary neovascularization , and in some cases the degree of vascularization appears to correlate with aggressive behavior and risk of metastasis . We hypothesized that carcinoma of the prostate also induces the formation of new capillaries , and we developed a method to quantify the relative density of microscopic vessels in carcinoma of the prostate compared with benign prostatic gl and ular tissue . The number of microvessel profiles in tissue sections was quantified by marking the vascular endothelial cells with antibodies to factor VIII-related antigen using st and ard immunohistochemistry techniques and comparing fields of adenocarcinoma with benign gl and ular tissue in 15 radical prostatectomy specimens . The analysis was facilitated by using the Optimas computerized image analysis system ( Bioscan , Seattle , WA ) with software written for this investigation . Fourteen of the 15 cases demonstrated significantly higher vascular density in the areas of carcinoma than in the benign tissues . Overall , the ratio of vessels per unit area in sections of carcinoma versus benign tissue was approximately double ( ratio = 2.02 ; P < .001 ) . In benign tissues the capillaries are restricted for the most part to the perigl and ular stroma immediately adjacent to the epithelium , whereas the distribution in carcinoma appears to be more r and om . The data demonstrate the increased density of capillaries in prostatic carcinoma when compared with benign prostate tissue BACKGROUND The prostate component of the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial was undertaken to determine whether there is a reduction in prostate cancer mortality from screening using serum prostate-specific antigen ( PSA ) testing and digital rectal examination ( DRE ) . Mortality after 7 - 10 years of follow-up has been reported previously . We report extended follow-up to 13 years after the trial . METHODS A total of 76 685 men , aged 55 - 74 years , were enrolled at 10 screening centers between November 1993 and July 2001 and r and omly assigned to the intervention ( organized screening of annual PSA testing for 6 years and annual DRE for 4 years ; 38 340 men ) and control ( usual care , which sometimes included opportunistic screening ; 38 345 men ) arms . Screening was completed in October 2006 . All incident prostate cancers and deaths from prostate cancer through 13 years of follow-up or through December 31 , 2009 , were ascertained . Relative risks ( RRs ) were estimated as the ratio of observed rates in the intervention and control arms , and 95 % confidence intervals ( CIs ) were calculated assuming a Poisson distribution for the number of events . Poisson regression modeling was used to examine the interactions with respect to prostate cancer mortality between trial arm and age , comorbidity status , and pretrial PSA testing . All statistical tests were two-sided . RESULTS Approximately 92 % of the study participants were followed to 10 years and 57 % to 13 years . At 13 years , 4250 participants had been diagnosed with prostate cancer in the intervention arm compared with 3815 in the control arm . Cumulative incidence rates for prostate cancer in the intervention and control arms were 108.4 and 97.1 per 10 \n Output:\n " }, { "from": "agent", "value": "These use quantitative elasticity values to differentiate benign from malignant areas of the prostate .\nThis method of assessment has shown that the elasticity changes for differing Gleason grade s and T stages of disease within the prostate .\nQuantitative elasticity values offer the potential of using ' threshold ' elasticity values under which the prostate is benign .\nTissue elasticity has great potential as a diagnostic and prognostic biomarker for prostate cancer and can be assessed using various methods .\nCurrently transrectal sonoelastography has the most evidence supporting its use in clinical practice" } ]
***TASK*** the task is to summarize an input biomedical literature in six sentences ***INPUT*** the input is a biomedical literature ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences ***DOCUMENTATION*** ***EXAMPLES*** Input: CONTEXT Three fourths of US men older than 50 years have been screened with prostate-specific antigen ( PSA ) for prostate cancer . OBJECTIVE To estimate the receiver operating characteristic ( ROC ) curve for PSA . DESIGN , SETTING , AND PARTICIPANTS Calculation of PSA ROC curves in the placebo group of the Prostate Cancer Prevention Trial , a r and omized , prospect i ve study conducted from 1993 to 2003 at 221 US centers . Participants were 18 882 healthy men aged 55 years or older without prostate cancer and with PSA levels less than or equal to 3.0 ng/mL and normal digital rectal examination results , followed up for 7 years with annual PSA measurement and digital rectal examination . If PSA level exceeded 4.0 ng/mL or rectal examination result was abnormal , a prostate biopsy was recommended . After 7 years of study participation , an end-of- study prostate biopsy was recommended in all cancer-free men . MAIN OUTCOME MEASURES Operating characteristics of PSA for prostate cancer detection , including sensitivity , specificity , and ROC curve . RESULTS Of 8575 men in the placebo group with at least 1 PSA measurement and digital rectal examination in the same year , 5587 ( 65.2 % ) had had at least 1 biopsy ; of these , 1225 ( 21.9 % ) were diagnosed with prostate cancer . Of 1213 cancers with Gleason grade recorded , 250 ( 20.6 % ) were Gleason grade 7 or greater and 57 ( 4.7 % ) were Gleason grade 8 or greater . The areas under the ROC curve ( AUC ) for PSA to discriminate any prostate cancer vs no cancer , Gleason grade 7 or greater cancer vs no or lower- grade cancer , and Gleason grade 8 or greater cancer vs no or lower- grade cancer were 0.678 ( 95 % confidence interval [ CI ] , 0.666 - 0.689 ) , 0.782 ( 95 % CI , 0.748 - 0.816 ) , and 0.827 ( 95 % CI , 0.761 - 0.893 ) , respectively ( all P values < .001 for AUC vs 50 % ) . For detecting any prostate cancer , PSA cutoff values of 1.1 , 2.1 , 3.1 , and 4.1 ng/mL yielded sensitivities of 83.4 % , 52.6 % , 32.2 % , and 20.5 % , and specificities of 38.9 % , 72.5 % , 86.7 % , and 93.8 % , respectively . Age-stratified analyses showed slightly better performance of PSA in men younger than 70 years vs those 70 years or older with AUC values of 0.699 ( SD , 0.013 ) vs 0.663 ( SD , 0.013 ) ( P = .03 ) . CONCLUSION There is no cutpoint of PSA with simultaneous high sensitivity and high specificity for monitoring healthy men for prostate cancer , but rather a continuum of prostate cancer risk at all values of PSA BACKGROUND Although the first laparoscopic radical prostatectomy was performed in 1997 , few midterm oncologic data have been published for the extraperitoneal procedure . OBJECTIVE To determine the oncologic outcome of extraperitoneal laparoscopic radical prostatectomy ( ELRP ) . DESIGN , SETTING , AND PARTICIPANTS From 2000 to 2007 , 1115 consecutive patients underwent ELRP for a localized prostate cancer at our department . Follow-up was scheduled and st and ardized for all patients and recorded into a prospect i ve data base . Median postoperative follow-up was 35.6 mo . INTERVENTION All ELRP were performed by three surgeons at the Department of Urology , Hospital Henri Mondor , Créteil , France . MEASUREMENTS Biochemical recurrence was defined by prostate-specific antigen level > or = 0.2 ng/ml . RESULTS AND LIMITATIONS In pN0/pNx cancers , postoperative stage was pT2 in 664 patients ( 59.5 % ) , pT3 in 350 patients ( 31.4 % ) , and pT4 in 77 patients ( 6.9 % ) . Positive lymph nodes were reported in 24 patients ( 2.2 % ) . Margins were positive in 16.1 % and 34.6 % of pT2 and pT3 cancers , respectively . Final Gleason score was < 7 in 288 men ( 25.8 % ) , = 7 in 701 men ( 62.9 % ) , and > 7 in 126 men ( 11.3 % ) . Overall prostate-specific antigen ( PSA ) recurrence-free survival was 83 % at 5 yr . The 5-yr progression-free survival rates were 93.4 % for pT2 , 74.5 % for pT3a , and 55.0 % for pT3b tumors , respectively . Multivariate Cox model showed that PSA , Gleason score , pT category , nodal status , and surgical margins were significant independent predictors of biochemical recurrence-free survival . CONCLUSIONS This assessment of oncologic results demonstrates that ELRP is a safe and effective procedure . On the basis of midterm follow-up data , the prognostic factors of PSA after ELRP failure are the same as those described previously in transperitoneal or open retropubic approaches . The oncologic results of ELRP also are in line with those reported with the use of the retropubic or the transperitoneal laparoscopic approaches PURPOSE To prospect ively evaluate multiparametric magnetic resonance imaging ( MRI ) for accurate localization of intraprostatic tumor nodules , with whole-mount histopathology as the gold st and ard . MATERIAL S AND METHODS Seventy-five patients with biopsy-proven , intermediate , and high-risk prostate cancer underwent preoperative T2-weighted ( T2w ) , dynamic contrast-enhanced ( DCE ) and diffusion-weighted ( DW ) MRI at 1.5 T . Localization of suspicious lesions was recorded for each of 24 st and ardized regions of interest on the different MR images and correlated with the pathologic findings . Generalized estimating equations ( GEE ) were used to estimate the sensitivity , specificity , accuracy , positive , and negative predictive value for every MRI modality , as well as to evaluate the influence of Gleason score and pT-stage . Tumor volume measurements on histopathological specimens were correlated with those on the different MR modalities ( Pearson correlation ) . RESULTS DW MRI had the highest sensitivity for tumor localization ( 31.1 % vs. 27.4 % vs. 44.5 % for T2w , DCE , and DW MRI , respectively ; P < 0.005 ) , with more aggressive or more advanced tumors being more easily detected with this imaging modality . Significantly higher sensitivity values were obtained for the combination of T2w , DCE , and DW MRI ( 58.8 % ) as compared to each modality alone or any combination of two modalities ( P < 0.0001 ) . Tumor volume can most accurately be assessed by means of DW MRI ( r = 0.75 ; P < 0.0001 ) . CONCLUSION Combining T2w , DCE , and DW imaging significantly improves prostate cancer localization PURPOSE The biology of prostate cancer may be influenced by the index lesion . The definition of index lesion volume is important for appropriate decision making , especially for image guided focal treatment . We determined the accuracy of magnetic resonance imaging for determining index tumor volume compared with volumes derived from histopathology . MATERIAL S AND METHODS We evaluated 135 patients ( mean age 59.3 years ) with a mean prostate specific antigen of 6.74 ng/dl who underwent multiparametric 3 T endorectal coil magnetic resonance imaging of the prostate and subsequent radical prostatectomy . Index tumor volume was determined prospect ively and independently by magnetic resonance imaging and histopathology . The ellipsoid formula was applied to determine histopathology tumor volume , whereas manual tumor segmentation was used to determine magnetic resonance tumor volume . Histopathology tumor volume was correlated with age and prostate specific antigen whereas magnetic resonance tumor volume involved Pearson correlation and linear regression methods . In addition , the predictive power of magnetic resonance tumor volume , prostate specific antigen and age for estimating histopathology tumor volume ( greater than 0.5 cm(3 ) ) was assessed by ROC analysis . The same analysis was also conducted for the 1.15 shrinkage factor corrected histopathology data set . RESULTS There was a positive correlation between histopathology tumor volume and magnetic resonance tumor volume ( Pearson coefficient 0.633 , p < 0.0001 ) , but a weak correlation between prostate specific antigen and histopathology tumor volume ( Pearson coefficient 0.237 , p = 0.003 ) . On linear regression analysis histopathology tumor volume and magnetic resonance tumor volume were correlated ( r(2 ) = 0.401 , p < 0.00001 ) . On ROC analysis AUC values for magnetic resonance tumor volume , prostate specific antigen and age in estimating tumors larger than 0.5 cm(3 ) at histopathology were 0.949 ( p < 0.0000001 ) , 0.685 ( p = 0.001 ) and 0.627 ( p = 0.02 ) , respectively . Similar results were found in the analysis with shrinkage factor corrected tumor volumes at histopathology . CONCLUSIONS Magnetic resonance imaging can accurately estimate index tumor volume as determined by histology . Magnetic resonance imaging has better accuracy in predicting histopathology tumor volume in tumors larger than 0.5 cm(3 ) than prostate specific antigen and age . Index tumor volume as determined by magnetic resonance imaging may be helpful in planning treatment , specifically in identifying tumor margins for image guided focal therapy and possibly selecting better active surveillance c and i date A variety of malignant neoplasms have been shown to induce capillary neovascularization , and in some cases the degree of vascularization appears to correlate with aggressive behavior and risk of metastasis . We hypothesized that carcinoma of the prostate also induces the formation of new capillaries , and we developed a method to quantify the relative density of microscopic vessels in carcinoma of the prostate compared with benign prostatic gl and ular tissue . The number of microvessel profiles in tissue sections was quantified by marking the vascular endothelial cells with antibodies to factor VIII-related antigen using st and ard immunohistochemistry techniques and comparing fields of adenocarcinoma with benign gl and ular tissue in 15 radical prostatectomy specimens . The analysis was facilitated by using the Optimas computerized image analysis system ( Bioscan , Seattle , WA ) with software written for this investigation . Fourteen of the 15 cases demonstrated significantly higher vascular density in the areas of carcinoma than in the benign tissues . Overall , the ratio of vessels per unit area in sections of carcinoma versus benign tissue was approximately double ( ratio = 2.02 ; P < .001 ) . In benign tissues the capillaries are restricted for the most part to the perigl and ular stroma immediately adjacent to the epithelium , whereas the distribution in carcinoma appears to be more r and om . The data demonstrate the increased density of capillaries in prostatic carcinoma when compared with benign prostate tissue BACKGROUND The prostate component of the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial was undertaken to determine whether there is a reduction in prostate cancer mortality from screening using serum prostate-specific antigen ( PSA ) testing and digital rectal examination ( DRE ) . Mortality after 7 - 10 years of follow-up has been reported previously . We report extended follow-up to 13 years after the trial . METHODS A total of 76 685 men , aged 55 - 74 years , were enrolled at 10 screening centers between November 1993 and July 2001 and r and omly assigned to the intervention ( organized screening of annual PSA testing for 6 years and annual DRE for 4 years ; 38 340 men ) and control ( usual care , which sometimes included opportunistic screening ; 38 345 men ) arms . Screening was completed in October 2006 . All incident prostate cancers and deaths from prostate cancer through 13 years of follow-up or through December 31 , 2009 , were ascertained . Relative risks ( RRs ) were estimated as the ratio of observed rates in the intervention and control arms , and 95 % confidence intervals ( CIs ) were calculated assuming a Poisson distribution for the number of events . Poisson regression modeling was used to examine the interactions with respect to prostate cancer mortality between trial arm and age , comorbidity status , and pretrial PSA testing . All statistical tests were two-sided . RESULTS Approximately 92 % of the study participants were followed to 10 years and 57 % to 13 years . At 13 years , 4250 participants had been diagnosed with prostate cancer in the intervention arm compared with 3815 in the control arm . Cumulative incidence rates for prostate cancer in the intervention and control arms were 108.4 and 97.1 per 10 Output:
MS212823
[{"from":"human","value":"***TASK*** the task is to summarize an input biomedical literature in six (...TRUNCATED)
"***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*(...TRUNCATED)
MS21477
[{"from":"human","value":"***TASK*** the task is to summarize an input biomedical literature in six (...TRUNCATED)
"***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*(...TRUNCATED)
MS26453
[{"from":"human","value":"***TASK*** the task is to summarize an input biomedical literature in six (...TRUNCATED)
"***TASK*** the task is to summarize an input biomedical literature in six sentences \n ***INPUT*(...TRUNCATED)
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