A comparative study of eyelid cleaning regimens in chronic blepharitis. Ketoconazole in the treatment of blepharitis. Efficacy of topical azithromycin ophthalmic solution 1% in the treatment of posterior blepharitis. The efficacy of topical metronidazole in the treatment of ocular rosacea. The role of omega-3 dietary supplementation in blepharitis and meibomian gland dysfunction (an AOS thesis). Efficacy of commercially available topical cyclosporine A 0.05% in the treatment of meibomian gland dysfunction. Efficacy and safety of mercuric oxide in the treatment of bacterial blepharitis. Efficacy of a new warm moist air device on tear functions of patients with simple meibomian gland dysfunction. Efficacy of topical cyclosporin 0.05% in the treatment of posterior blepharitis. A long-term study on the effect of spontaneous consumption of reduced fat products as part of a normal diet on indicators of health. Do catheter washouts extend patency time in long-term indwelling urethral catheters? A randomized controlled trial of acidic washout solution, normal saline washout, or standard care. Subjective assessment of a new moisturizing mouth spray for the symptomatic relief of dry mouth. Acceptability evaluation of a natural rubber latex, a polyurethane, and a new non-latex condom. Placebo controlled trial of fusidic acid gel and oxytetracycline for recurrent blepharitis and rosacea. [Bibrocathol eye ointment is efficacious in blepharitis. Results from a randomized, double-blind, controlled clinical trial]. Epidemiology of research into interventions for the treatment of osteoarthritis of the knee joint. Prescribers' responses to alerts during medication ordering in the long term care setting. The practical effects of errors in reference lists in nursing research journals. Increase in tear film lipid layer thickness following treatment with warm compresses in patients with meibomian gland dysfunction. Midwifery care measures in the second stage of labor and reduction of genital tract trauma at birth: a randomized trial. The impact of modified Hatha yoga on chronic low back pain: a pilot study. A randomized trial of a screening, case finding, and referral system for older veterans in primary care. Cross validation of some psychometric properties of the CSQ and its differential return rate as a function of token financial incentive. The relationship between the outcome of studies of autologous chondrocyte implantation and the presence of commercial funding. What picture is worth a thousand words? A comparative evaluation of a burn prevention programme by type of medium in Israel. Blepharitis and the collagen eye patch. Effects of training on quality of peer review: randomised controlled trial. A pilot study of mind-body changes in adults with asthma who practice mental imagery. The quality of reporting of randomized controlled trials in solid organ transplantation. Comparative evaluation of three Tactylon(TM) condoms and a latex condom during vaginal intercourse: breakage and slippage.
Blepharitis, an intrinsic eyelid inflammation with crusting and irritation, presents a great problem for patients wearing contact lenses. An important part of blepharitis therapy is eyelid hygiene, including the use of either soap, dilute baby shampoo, or commercial lid scrubs. In this study, a comparison was made between these three cleaning regimens in a group of 25 patients, 80% of whom (20/25) wore contact lenses.
                Patients used commercial eyelid scrub on right eyelids and a hypo-allergenic bar soap on left eyelids. Patient symptoms, slit lamp findings, and overall preferences were determined at the end of 4 months. A subgroup of 10 patients using lid scrub on right eyelids and dilute baby shampoo on left eyelids was followed for an additional 3 months.
                At the end of 4 months, 24% (6/25) of the patients noted no difference between soap and lid scrub, but 89% (17/19) of the others preferred the lid scrub. In the group using baby shampoo, 50% (5/10) noted no difference in 3 months, but 80% (4/5) of the remaining patients preferred the lid scrub.
                All patients improved in slit lamp findings with all three regimens, and patient preference was overwhelmingly in favor of the lid scrub regimen for convenience and ease of use. A double masked, placebo controlled clinical trial, of topical 2% ketoconazole cream with lid hygiene, for the treatment of seborrhoeic and mixed seborrhoeic/staphylococcal blepharitis was conducted. Forty patients with symptomatic blepharitis, 20 randomly allocated to ketoconazole, 20 to placebo were entered. Treatment efficacy was assessed by improvement of symptoms using visual analogue scales, appearance of the eyelids and reduction in numbers of pityrosporum yeasts on the eyelids. Both groups showed a similar reduction in symptoms, and signs of inflammation. The overall clinical impression in the ketoconazole group was better at week five than in the placebo group. Sixty nine per cent were either normal or markedly improved, as compared to 42% in the placebo group, although this was not statistically significant (p less than 0.1, one-sided Mann-Whitney). Pityrosporum numbers were reduced significantly in both groups during the treatment period. Ketoconazole was no better than placebo at improving the symptoms of blepharitis. More ketoconazole treated patients had normal or markedly improved lids after treatment than the placebo group. Pityrosporum yeasts may play a role in blepharitis, and treatment with an antifungal has some advantages over conventional therapy. Azithromycin, a broad-spectrum antibiotic with potent anti-inflammatory activities, has the potential to effectively treat blepharitis, an inflammatory disease of the eyelid with abnormal eyelid flora as an etiologic determinant. The present study compared the efficacy of topical azithromycin ophthalmic solution 1% (AzaSite; Inspire Pharmaceuticals, Inc, NC, USA) combined with warm compresses (azithromycin group) to warm compresses alone (compress group) in patients with posterior blepharitis.
                Twenty-one patients diagnosed with posterior blepharitis were randomized in an open-label study to receive either azithromycin plus warm compresses (10 patients), or compresses alone (11 patients). All patients were instructed to apply compresses to each eye for 5-10 minutes twice daily for 14 days. Each eye in the azithromycin group also received azithromycin solution (1 drop) twice daily for the first 2 days followed by once daily for the next 12 days. Patients were evaluated at study initiation (visit 1) and at end of treatment (visit 2) for the severity of five clinical signs: eyelid debris, eyelid redness, eyelid swelling, meibomian gland (MG) plugging, and the quality of MG secretion. At visit 2, patients also rated their degree of overall symptomatic relief.
                Twenty patients completed the study. At visit 2, patients in the azithromycin group demonstrated significant improvements in MG plugging, MG secretions, and eyelid redness as compared with the compress group. In the azithromycin group, MG plugging resolved completely in three patients and MG secretion returned to normal in two patients; no such results were seen in the compress group. Furthermore, a higher percentage of patients in the azithromycin group rated overall symptomatic relief as excellent or good. Visual acuity measurements and biomicroscopic evaluation revealed no ocular safety issues.
                Azithromycin ophthalmic solution in combination with warm compresses provided a significantly greater clinical benefit than warm compresses alone in treating the signs and symptoms of posterior blepharitis. The purpose of the study is to investigate the efficacy of metronidazole topical gel in the treatment of ocular rosacea.
                Ten patients with ocular rosacea were treated prospectively with lid hygiene and topical metronidazole applied to the lid margin in one eye and lid hygiene alone in the fellow eye. The treatment period was 12 weeks. A masked observer graded the ocular findings at the initial visit and at the conclusion of the treatment period. Pretreatment scores were compared with post-treatment scores with respect to ocular surface, eyelid margin, and combined eyelid plus ocular surface.
                Eight of ten treated eyes improved, whereas only five of ten control eyes improved. There was a statistically significant improvement in the eyelid score in both the treated and control groups (P = 0.003, P = 0.025, respectively), but no significant improvement in the ocular surface score in either group. When the pretreatment and post-treatment eyelid and ocular surface scores were combined, there was a significant improvement in the treated eyes but not in the control eyes (P = 0.022, P = 0.10, respectively). No adverse effects of the metronidazole treatment were encountered in this study.
                Metronidazole topical gel may be a safe and effective means of treating rosacea blepharitis. Blepharitis and meibomian gland dysfunction (MGD) are common sources of complaints from patients. To evaluate the effect on ocular symptoms, ocular findings, and serum and meibomian gland contents, patients with blepharitis and MGD were prospectively evaluated to determine the effects of dietary supplementation with omega-3 fatty acids.
                In a prospective randomized placebo-controlled masked trial, patients with simple obstructive MGD and blepharitis, who had discontinued all topical medications and tetracyclines, received oral omega-3 dietary supplementation consisting of two 1000-mg capsules 3 times a day. Patients were examined every 3 months for 1 year with the Ocular Surface Disease Index (OSDI) objective clinical measures, including tear production and stability, ocular surface and meibomian gland health, and biochemical plasma, red blood cell (RBC), and meibum evaluation. Primary outcome measures were change in tear breakup time (TBUT), meibum score, and overall OSDI score at 1 year.
                At 1 year, the omega-3 group had a 36% and 31% reduction in their omega-6 to omega-3 fatty acid ratios in RBCs and plasma, respectively (P = .3), whereas the placebo group demonstrated no change. At 12 months, the omega-3 group had an improvement in TBUT, OSDI score, and meibum score. Changes in meibum content were observed in the omega-3 group (P = .21); the level of meibum saturated fatty acids decreased.
                This trial demonstrated a decrease in the RBC and plasma ratios of omega-6 to omega-3 in patients taking omega-3 dietary supplementation, as compared to controls, and improvements in their overall OSDI score, TBUT, and meibum score. This is the first demonstration of an induced change in the fatty acid saturation content in meibum as a result of dietary supplementation with omega-3 fatty acids. To investigate the efficacy of topical cyclosporine A 0.05% (tCsA) (Restasis, Allergan Pharmaceuticals) in the treatment of meibomian gland dysfunction (posterior blepharitis).
                Thirty-three patients with symptomatic meibomian gland dysfunction were randomized in a prospective study to either tCsA or placebo (Refresh Plus preservative-free artificial tears), 2 times daily for 3 months. They were evaluated at baseline and at 1, 2, and 3 months for subjective symptoms and objective signs including meibomian gland inclusions, lid margin vascular injection, tarsal telangiectasis, fluorescein staining, tear breakup time, and Schirmer scores.
                Twenty-six patients completed the study. All patients were tested for ocular symptoms, lid margin vascularity, tarsal telangiectasis, meibomian gland inclusions, tear breakup time, and fluorescein staining. At the 3-month visit, the tCsA group showed a greater improvement in ocular symptoms than the placebo group, but this difference was not statistically significant. At the 3-month visit, several objective examination findings were statistically significantly (P < 0.05) improved in the tCsA group compared with the placebo group. These differences included lid margin vascular injection, tarsal telangiectasis, and fluorescein staining. The most significant finding (P = 0.001) was the greater decrease in the number of meibomian gland inclusions in the tCsA group compared with the placebo group.
                Topical CsA may be helpful in the treatment of meibomian gland dysfunction (posterior blepharitis). Topical CsA did not induce an improvement in the symptoms, but it did decrease the number of meibomian gland inclusions in patients with meibomian gland dysfunction. A double-masked, placebo-controlled, randomized study was done to assess the safety and clinical and quantitative microbiologic efficacy of 1% mercuric oxide (yellow) ophthalmic ointment in the treatment of eyelid infections, i.e., bacterial blepharitis. A total of 39 patients with bacterial counts and clinical signs indicative of eyelid infection were treated twice daily for 7 days. Clinical biomicroscopic examination and quantitative microbiologic cultures were done just prior to initiation of treatment and again on days 3 and 7. Statistical analysis revealed a significant improvement in the clinical signs, bacterial count, cure rate, and improvement rate for subjects taking the active medication, compared with those taking the placebo on days 3 and 7. In addition, the medication was well tolerated. To evaluate the safety and efficacy of an original warm moist air device on tear functions and ocular surface of patients with simple meibomian gland dysfunction (MGD).
                Fifteen patients with simple MGD and 20 healthy volunteers were recruited in an initial prospective interventional clinical trial to evaluate the safety and short-term effects of the warm moist air device. The device was applied to the eyes of the subjects for 10 minutes. Temperatures of the eye lids and corneas were measured with an infrared thermometer. Symptoms of ocular fatigue were scored using visual analog scales (VASs). Schirmer test, tear film break-up time (BUT), DR-1 tear film lipid layer interferometry, fluorescein staining, and rose bengal staining were also performed before and after the application of the eye steamer. After the initial study, another 2-week prospective clinical trial was carried out in 10 patients with MGD who received the warm moist air treatment. Ten other patients were also recruited and received warm compress treatment with hot towels for 2 weeks to evaluate the long-term effects of the warm moist air device and the warm compresses on tear film lipid layer thickness and ocular surface health. The warm moist air device and the warm compresses were applied for 10 minutes twice a day. The changes in VAS scores for symptoms, BUT values, fluorescein, and rose bengal staining scores were examined before and after each treatment during the second trial.
                VAS scores of ocular fatigue improved significantly with short- and long-term applications of the warm moist air device in both studies. The mean corneal surface and eye lid temperatures showed significant elevation within safe limits 10 minutes after the moist air application. The mean BUT prolonged significantly in the patients receiving warm moist air applications but did not change significantly in those treated with warm compresses. DR-1 tear film lipid layer interference showed evidence of lipid expression in the patients and controls, with thickening of the tear film lipid layer after 10 minutes of warm moist air device use. In the 2-week trial, tear film lipid layer thickness increased in both warm moist air device and warm compress groups, with a greater extent of increase in the warm moist air device group.
                Warm moist air device use provided symptomatic relief of ocular fatigue and improvement of tear stability in patients with MGD. The new warm moist air device seems to be a safe and promising alternative in the treatment of MGD. We assessed the efficacy of topical cyclosporin 0.05% ophthalmic emulsion versus tobramycin 0.3%/dexamethasone 0.1% in patients with posterior blepharitis. Posterior blepharitis improved significantly from the initial study visit with both cyclosporin treatment and tobramycin/dexamethasone. Cyclosporin provided greater improvements in Schirmer's scores (P < 0.001) and tear break-up time (P = 0.018) than tobramycin/dexamethasone after 12 weeks of treatment. Eyelid health also improved in both groups, but the mean improvement in meibomian gland secretion quality was significantly greater with cyclosporin than with tobramycin/dexamethasone (P = 0.015). Moreover, a higher percentage of patients in the cyclosporin treatment group had improvements in symptoms of blurred vision, burning, and itching and more cyclosporin-treated patients experienced resolution of lid telangiectasia. The findings in this prospective study suggest that posterior blepharitis can be more effectively treated with cyclosporin than with tobramycin/dexamethasone. These findings should be further evaluated in large-scale, controlled, clinical trials. The growing public concern with the adverse effects on health of a high fat intake has led to a proliferation on the market of reduced fat products. However, no consensus exists on the effectivity of reduced fat products to decrease energy intake. The studies that have investigated this topic have included small numbers of subjects, studied under laboratory conditions and over a relatively short period of time. Therefore, we have executed a long-term study in which volunteers had free access to both reduced fat, commercially available products in the laboratory as well as to products obtained from regular shops. We here report the feasibility of such a type of study and the effects of consumption of reduced fat products on blood levels of cholesterol, haemostasis variables, antioxidants and parameters of the immune system. The study was a multicentre parallel comparison trial of six months (so-called MSFAT-study). 241 volunteers received either reduced fat products or full-fat products and the products were clearly labelled as such. Two months before the start of the study, a 1 month adaptation period was executed to optimize the experimental procedures. Food intake was recorded before the start of the adaptation period and 2-4 weeks, 3 months and 6 months after the start of the study. Blood samples were taken before, after 2, 4 and 6 months of the study. In addition, a selection of the reduced fat and full-fat products was sensorically evaluated three times during the study by a subgroup of the volunteers. 220 volunteers completed the study. The reduced fat group consumed on average 46% less fat from the so-called MSFAT-products obtained from the shop at the laboratory than the control group and consumption of these MSFAT-products did not decrease in either of the groups during the time course of the study. The palatability of the reduced fat and full-fat products was similar and as expected, the perceived fattiness of the full-fat products was higher than that of the reduced fat products. No effects were found on blood levels of cholesterol, haemostasis variables, parameters of antioxidant status and immune system characteristics. In conclusion, the experimental manipulation of the fat content of the diet that was achieved and that remained stable throughout the 6 months of the study indicates that this type of set-up is feasible to assess the effects of long-term nutritional intervention in large groups of volunteers under semi-controlled conditions. The regular use of reduced fat products did not positively but also not adversely affect blood cholesterol levels, antioxidant status, haemostasis factors and the body's immune system. Blockage of long-term indwelling catheters with mineral deposit is an ongoing management issue, but evidence on optimal management is lacking. Our purpose was to examine whether catheter washouts prevent or reduce catheter blockage.
                A multisite randomized controlled trial.
                Adults with long-term indwelling catheters that required changing every 3 weeks or less, living in the community, and requiring supportive or continuing care were recruited. Participants were randomly assigned to 1 of 3 groups: control (usual care, no washout), saline washout, or commercially available acidic washout solution (Contisol Maelor Pharmaceuticals Ltd, Wrexham, UK).
                At baseline visit, the catheter was changed and participants were followed weekly for 8 weeks, with checks for catheter patency and urine pH. Participants randomized to saline or commercial solution had a weekly washout with the appropriate solution. Endpoints were 8 weeks (completion data), 3 or more catheter changes in the 8-week period, or symptomatic urinary tract infection (UTI) requiring antibiotics. The study hypothesis was that catheter life would be extended by 25% in the commercial solution group. It was not possible to blind participants or research nurses to washout versus no intervention, but participants in the saline and washout solution groups were blinded to solution type.
                One hundred twelve potential participants were screened; 73 were enrolled, randomized, and included in the final analysis. Of these, 53 completed the full 8 weeks of data collection; 16 terminated early because of 3 catheter changes or self-reported 'UTI'. Other reasons for termination were hematuria, latex sensitivity, deceased/severe illness, or personal choice. Analysis of variance was used to analyze mean differences on demographic variables and mean number of weeks in study. Kaplan-Meier survival curve analysis showed no statistical difference between the groups in time to first catheter change.
                At this time, the evidence is insufficient to state whether catheter washout with saline or Contisol is more effective than usual care with no washout in preventing blocking. No increased risk of UTI was associated with washout regimes. A randomized clinical trial (Study 1) and consumer usage test (Study 2) were conducted to evaluate the acceptability and efficacy of OASIS Mouth Moisturizing Spray in subjects experiencing dry mouth.
                Study 1: A randomized, single-blind, four-arm crossover clinical trial was conducted in 24 subjects, ranging from 50-84 years of age, to evaluate OASIS Mouth Moisturizing Spray and two experimental mouth spray formulations, and compare their performance to a reference (marketed) mouth spray, SALIVEZE. Following a three-day acclimatization phase, subjects used all four products at home for three days. Each treatment phase was separated by a three-day washout period. Study 2: One-hundred twenty subjects participated in a three-week home usage consumer test using OASIS Mouth Moisturizing Spray, after which they completed a 52-question online survey exploring sensory, efficacy, and resultant quality of life attributes of the product.
                Study 1: On average, subjects used the four test products 2-3 times per day. OASIS Mouth Moisturizing Spray was found to be effective in relieving dry mouth in the study population, as evidenced by a statistically significant feeling of coating the mouth (p < 0.05), and statistically significantly longer dry mouth relief (p < 0.005) than the commercial control. The OASIS Mouth Moisturizing Spray was statistically significantly (p < 0.05) better and preferred over the other product tested. All the products used in the study were well-tolerated. Study 2: On a five-point scale, 73% of respondents perceived the OASIS Mouth Moisturizing Spray as "very good" or "excellent," and more than 60% gave the product an "excellent" or "very good" rating on sensory, efficacy, and quality of life attributes.
                These studies show that OASIS Mouth Moisturizing Spray helped provide dry mouth relief and was well liked by the study population. After more than a century of reliance on latex condoms, male condoms fabricated from new materials are finally becoming commercially available to consumers. This study was an open label acceptability study that compared three lubricated condom products during vaginal intercourse: a natural rubber latex condom, a polyurethane condom, and a new non-latex (styrene ethylene butylene styrene, SEBS) condom. Fifty-four couples who were using condoms for birth control were enrolled in this three-way crossover study. Each couple tested three condoms of each type in a randomized sequence. Couples reported condom performance after each use and rated condom acceptability after use of three condoms of each type. At the completion of the study, participants selected their preferred condom type for overall acceptability, sensitivity, ease of use, appearance, and comfort. All three condom types had low clinical breakage and slippage rates (</= 3.3%) although the polyurethane condom did not perform as well in other measures of performance including unrolling, discomfort, stretching, bunching, and sliding along the penis during intercourse. None of the condom types were statistically preferred overall [males: natural rubber latex 37%, polyurethane 24%, new non-latex (SEBS) 37%, no preference 2%; females: natural rubber latex 33%, polyurethane 27%, new non-latex 37%, no preference 2%]. A statistically higher proportion of couples preferred both the natural rubber latex condom and the new non-latex condom above the polyurethane condom for ease of unrolling, and the natural rubber latex condom above the other condom types for perceived safety. Approximately two-thirds of both male and female participants preferred one of the two condoms made of synthetic materials suggesting that consumers will appreciate the availability of these products. A prospective, randomised, double blind, partial crossover, placebo controlled trial has been conducted to compare the performance of topical fusidic acid gel (Fucithalmic) and oral oxytetracycline as treatment for symptomatic chronic blepharitis. Treatment success was judged both by a reduction in symptoms and clinical examination before and after therapy. Seventy five per cent of patients with blepharitis and associated rosacea were symptomatically improved by fusidic acid gel and 50% by oxytetracycline, but fewer (35%) appeared to benefit from the combination. Patients with chronic blepharitis of other aetiologies did not respond to fusidic acid gel but 25% did benefit from oxytetracycline and 30% from the combination. Our results demonstrate the need to investigate patients with blepharitis for concomitant rosacea as they respond well to targeted therapy. Bibrocathol (Noviform) 5% ointment is a frequently used therapy for blepharitis. The study included 197 patients who were randomized to be treated over 2 weeks with bibrocathol or an ointment vehicle, respectively. Slit lamp examinations were performed on day 1 (baseline) and day 14 (end of study) to assess lid edema, lid erythema, debris, and pouting of Meibomian glands; patients rated their subjective complaints. Bibrocathol was superior to the control treatment in improving the sum score of the 5 scales (by 7.0 vs 4.7 points, p<0.001), especially in patients with primarily severe symptoms (by 8.3 vs 4.8, p<0.0001). Antiseptic therapy with bibrocathol eye ointment 3 times daily over 2 weeks was found to be efficacious in the treatment of acute forms of blepharitis which do not require antibiotic therapy. Bibrocathol treatment is well tolerated and safe. To assess the published research base for interventions for osteoarthritis of the knee, and to identify areas in need of further research.
                Literature searches were conducted on electronic databases (Medline, Embase, ISI, and Cochrane library), bibliographies of existing review articles were hand searched, and a postal questionnaire was sent to members of the Osteoarthritis Research Society International. All relevant articles were copied and searched for treatment type, study methodology, statistical results, conclusions, funding source, researcher affiliations, and year of publication, using a predetermined data extraction form.
                There have been marked changes in the literature over the period studied (1950-98), with a recent rise in trials of physical therapy, educational interventions, and complementary treatments. However, overall, most research was either drug (59.1%) or surgically (25.6%) related. Most of the studies reported positive results (94%). Research on oral drugs was significantly more likely to provide a positive result than research on any other intervention (p<0.001 by chi(2) test). Commercially funded studies were significantly more likely to produce a positive result than non-commercially funded research (p=0.0027 by chi(2) test).
                Analysis of time trends indicates that the research agenda does shadow changes in consumer demands. However, there are significant gaps in the research base that need to be considered. Computerized physician order entry with clinical decision support has been shown to improve medication safety in adult inpatients, but few data are available regarding its usefulness in the long-term care setting. The objective of this study was to examine opportunities for improving medication safety in that clinical setting by determining the proportion of medication orders that would generate a warning message to the prescriber via a computerized clinical decision support system and assessing the extent to which these alerts would affect prescribers' actions.
                The study was set within a randomized controlled trial of computerized clinical decision support conducted in the long-stay units of a large, academically-affiliated long-term care facility. In March 2002, a computer-based clinical decision support system (CDSS) was added to an existing computerized physician order entry (CPOE) system. Over a subsequent one-year study period, prescribers ordering drugs for residents on three resident-care units of the facility were presented with alerts; these alerts were not displayed to prescribers in the four control units.
                We assessed the frequency of drug orders associated with various categories of alerts across all participating units of the facility. To assess the impact of actually receiving an alert on prescriber behavior during drug ordering, we calculated separately for the intervention and control units the proportion of the alerts, within each category, that were followed by an appropriate action and estimated the relative risk of an appropriate action in the intervention units compared to the control units.
                During the 12 months of the study, there were 445 residents on the participating units of the facility, contributing 3,726 resident-months of observation time. During this period, 47,997 medication orders were entered through the CPOE system-approximately 9 medication orders per resident per month. 9,414 alerts were triggered (2.5 alerts per resident-month). The alert categories most often triggered were related to risks of central nervous system side-effects such as over-sedation (20%). Alerts for risk of drug-associated constipation (13%) or renal insufficiency/electrolyte imbalance (12%) were also common. Twelve percent of the alerts were related to orders for warfarin. Overall, prescribers who received alerts were only slightly more likely to take an appropriate action (relative risk 1.11, 95% confidence interval 1.00, 1.22). Alerts related to orders for warfarin or central nervous system side effects were most likely to engender an appropriate action, such as ordering a recommended laboratory test or canceling an ordered drug.
                Long-term care facilities must implement new system-level approaches with the potential to improve medication safety for their residents. The number of medication orders that triggered a warning message in this study suggests that CPOE with a clinical decision support system may represent one such tool. However, the relatively low rate of response to these alerts suggests that further refinements to such systems are required, and that their impact on medication errors and adverse drug events must be carefully assessed. Previous studies have noted the prevalence of errors in journal reference lists, including nursing journals, but an in-depth study of nursing research journals has not been repeated.
                The purpose of this study was to determine the number and types of errors in nursing research journal reference lists.
                A stratified random sample of 262 references from three nursing research journals was obtained. References were compared with the actual articles, books, and chapters cited, or with photocopies obtained via interlibrary loan. Error rates were calculated.
                The overall error rate was 45.8%; 38.3% of all references contained at least one major error, and 13.8% of all references contained at least one minor error.
                The overall rate of reference errors falls within the range exhibited by recent studies of the medical and dental literature but exceeds the rates found in studies of nursing journals and veterinary medicine journals. Researchers need to consider the number and types of errors involved when using reference lists in their research. Warm-compress therapy applied to the skin of the closed eyelids has been recommended as a treatment for meibomian gland dysfunction (MGD). Previous studies have evaluated the effects of warm-compress therapy on tear-film fluorescein break-up time and tear evaporation rate. The purpose of this study was to determine if tear-film lipid layer thickness (TFLLT) was altered following 5, 15, and 30 minutes of warm, moist compress therapy.
                Twenty patients with a diagnosis of dry eye associated with MGD and a baseline TFLLT of <or= 90 nm (baseline difference between experimental and control eyes <or= 25 nm) were studied. The skin of the closed eyelids of one eye of each subject was treated for a total of 30 minutes with a compress saturated with warm (40.0 +/- 2.0 degrees C) water used as a compress; and the skin of the closed eyelids of the contralateral control eye was treated for a total of 30 minutes with a compress saturated with room-temperature (24.0 degrees C +/- 1.0 degrees C) water used as a compress. The subjects' eyes were randomized into experimental and control eyes. TFLLT was measured at the following time points: 5, 15, and 30 minutes during the 30-minute treatment period, and after 5 minutes following the 30-minute treatment period.
                The mean baseline TFLLT of the experimental eye prior to treatment with a warm, moist compress was 57.8 +/- 12.9 (standard error) nm; after 5 minutes of treatment, TFLLT was 105.8 +/- 23.7 nm; after 15 minutes of treatment, 117.8 +/- 26.4 nm; after 30 minutes of treatment, 121.5 +/- 27.1 nm; and after 5 minutes following the 30-minute treatment, 96.0 +/- 21.5 nm. The mean baseline TFLLT of the control eye prior to treatment with a room temperature, moist compress was 63.0 +/- 14.1 nm; after 5 minutes of treatment, TFLLT was 63.8 +/- 14.3 nm; after 15 minutes of treatment, 62.3 +/- 13.9 nm; after 30 minutes of treatment, 64.5 +/- 14.4 nm; and after 5 minutes following the 30-minute treatment period, 58.5 +/- 13.1 nm. Using a paired-data t-test, the results demonstrated a significant increase in mean TFLLT in the experimental eye after 5 minutes (P < 0.001), 15 minutes (P < 0.001), and 30 minutes (P < 0.001) of treatment, and after 5 minutes following the 30-minute treatment period (P < 0.001) when compared to baseline TFLLT. In comparison, there was no significant increase in TFLLT of the control eye after 5 minutes (P = 0.79), 15 minutes (P = 0.77), and 30 minutes (P = 0.81) of treatment, and after 5 minutes following the 30-minute treatment period (P = 0.20) when compared to baseline TFLLT.
                Warm, moist compress therapy applied to the skin of the closed eyelids increases TFLLT for subjects with MGD by more than 80%, 5 minutes after initiating treatment and an additional 20% after 15 minutes of treatment. This study supports clinical experience and previous reports on warm, moist compress therapy as an effective treatment for meibomian gland dysfunction. Genital tract trauma after spontaneous vaginal childbirth is common, and evidence-based prevention measures have not been identified beyond minimizing the use of episiotomy. This study randomized 1211 healthy women in midwifery care at the University of New Mexico teaching hospital to 1 of 3 care measures late in the second stage of labor: 1) warm compresses to the perineal area, 2) massage with lubricant, or 3) no touching of the perineum until crowning of the infant's head. The purpose was to assess whether any of these measures was associated with lower levels of obstetric trauma. After each birth, the clinical midwife recorded demographic, clinical care, and outcome data, including the location and extent of any genital tract trauma. The frequency distribution of genital tract trauma was equal in all three groups. Individual women and their clinicians should decide whether to use these techniques on the basis of maternal comfort and other considerations. The purpose of this randomized pilot study was to evaluate a possible design for a 6-week modified hatha yoga protocol to study the effects on participants with chronic low back pain.
                Twenty-two participants (M = 4; F = 17), between the ages of 30 and 65, with chronic low back pain (CLBP) were randomized to either an immediate yoga based intervention, or to a control group with no treatment during the observation period but received later yoga training.
                A specific CLBP yoga protocol designed and modified for this population by a certified yoga instructor was administered for one hour, twice a week for 6 weeks. Primary functional outcome measures included the forward reach (FR) and sit and reach (SR) tests. All participants completed Oswestry Disability Index (ODI) and Beck Depression Inventory (BDI) questionnaires. Guiding questions were used for qualitative data analysis to ascertain how yoga participants perceived the instructor, group dynamics, and the impact of yoga on their life.
                To account for drop outs, the data were divided into better or not categories, and analyzed using chi-square to examine differences between the groups. Qualitative data were analyzed through frequency of positive responses.
                Potentially important trends in the functional measurement scores showed improved balance and flexibility and decreased disability and depression for the yoga group but this pilot was not powered to reach statistical significance. Significant limitations included a high dropout rate in the control group and large baseline differences in the secondary measures. In addition, analysis of the qualitative data revealed the following frequency of responses (1) group intervention motivated the participants and (2) yoga fostered relaxation and new awareness/learning.
                A modified yoga-based intervention may benefit individuals with CLB, but a larger study is necessary to provide definitive evidence. Also, the impact on depression and disability could be considered as important outcomes for further study. Additional functional outcome measures should be explored. This pilot study supports the need for more research investigating the effect of yoga for this population. To test whether a system of screening, assessment, referral, and follow-up provided within primary care for high-risk older outpatients improves recognition of geriatric conditions and healthcare outcomes.
                Controlled clinical trial with 3-year follow-up; intervention versus control group allocation based on practice group assignment.
                Department of Veterans Affairs (VA) ambulatory care center.
                Seven hundred ninety-two community-dwelling patients aged 65 and older identified by postal screening survey.
                The intervention combined a structured telephone geriatric assessment by a physician assistant, individualized referrals and recommendations, selected referral to outpatient geriatric assessment, and ongoing telephone case management.
                Main outcomes were VA medical record evidence of recognition and evaluation of target geriatric conditions (depression, cognitive impairment, urinary incontinence, falls, functional impairment), functional status (Functional Status Questionnaire, FSQ), and hospitalization (VA databases and self-reported non-VA usage).
                Intervention participants were more likely to have target conditions recognized, evaluated, and referred to specialized services within 12 months of enrollment, although there were no significant differences in FSQ scores or acute hospitalization between intervention and control groups at 1, 2, or 3 years follow-up. Subgroup analyses suggested improvements in depression symptoms and functional impairment at 1-year follow-up in intervention participants with these problems at baseline, but these findings were not evident at later follow-up.
                The intervention increased recognition and evaluation of target geriatric conditions but did not improve functional status or decrease hospitalization. Innovative screening methods can identify older people in need of geriatric services, but achieving measurable improvement in functional status or hospitalization rates will likely require a more-intensive intervention than a program involving primarily unsolicited referrals and short-term consultations. The Consumer Satisfaction Questionnaire (CSQ) was developed by Larsen, Atkisson, Hargreaves, and Nguyen (1979) and has been mentioned as a possible "standard scale" for the evaluation of consumer satisfaction with mental health treatment because of its unidimensionality, reliability, validity and ease of use. A mail survey of ex-clients who had terminated treatment during the preceding year from one of six offices of a regional mental health center in the Rocky Mountain area strongly cross-validated these characteristics as well as other results from the consumer satisfaction literature. In addition, based upon evidence from marketing research, a randomly selected half of the ex-clients surveyed was offered a token inducement of two cents for returning the questionnaire while the other half was not. A significantly greater proportion of ex-clients who received the token inducement returned their questionnaires than did those who had not. This approach appears to be promising and further research with it is indicated. Autologous chondrocyte implantation (ACI) is an expensive treatment option for focal cartilage defects, and commercial funding of research is associated with a study reaching a positive conclusion. The purpose of this analysis is to compare outcomes (and levels of evidence) between published ACI outcome studies that were commercially funded and studies that were not commercially funded.
                Commercially funded ACI literature could be commercially biased.
                Comparative meta-analysis.
                MEDLINE was searched for human, knee, ACI, nonmembrane, English language, and clinical outcome studies. Studies were evaluated with regard to funding status (commercially funded or not commercially funded), outcomes, and levels of evidence. Outcomes and levels of evidence were evaluated and compared for commercially funded studies versus those that were not commercially funded.
                Twenty-three studies were included; 16 (70%) were commercially funded. Pooled clinical outcome measures data were not significantly different (Lysholm, Modified Cincinnati, patient-reported Cincinnati, Tegner, pain Visual Analog Scale) when comparing commercially funded studies with those that were not commercially funded. However, distribution of levels of evidence was significantly lower (P = .045) for commercially funded studies.
                Reassuringly, commercial funding of ACI studies did not result in a difference in published clinical outcomes versus those that were not commercially funded. However, the lower levels of evidence of commercially funded studies suggests that commercially funded ACI studies may be of less value to surgeons desiring to practice evidence-based medicine, and, in the future, commercial entities funding medical research could selectively fund studies of the highest levels of evidence. Burns are associated with longer hospital stay, permanent disfigurement and emotional stress disorders, and represent a health problem, especially among economically and socially deprived populations, such as the Bedouin population in Israel, hence the importance of intervention programmes. The objective of this research was to examine the extent to which the effect of a visual one-session burn prevention programme was determined by the type of medium used. We also examined the possibility that fear motivates action only when someone feels confident in his/her ability to control the threat. Data were based on the pre-/post-programme self-report questionnaires administered to a randomly selected three-group sample of 12- to 13-year-old Bedouin children (n=179). All three sessions were identical, but differed in the type of medium used: slides (S), video (V), or slides and video consecutively (S + V). We measured health beliefs (perceived threat, internal/external control, self-efficacy) and sense of coherence (SOC), both before and 2 months after completion of the intervention. We also measured post-programme fear reaction and the improvement in burn-related knowledge, understanding and safety behaviour as the outcome measure. No significant post-programme differences between intervention groups were found, either in terms of outcome measure or in terms of health beliefs and SOC. However, within- person analysis indicated that the S group participants had the highest level of post-exposure fear and a decrease in luck control over injuries. The S + V group demonstrated the lowest within change. The hierarchical regression analysis revealed that self-efficacy, fear, higher socio-economic status and female gender predicted improvement. As hypothesized, the interaction between fear and self-efficacy added significantly to prediction. It seems that health beliefs and demographic characteristics were more powerful in predicting the effect of the intervention than the choice of medium per se. A multifaceted approach and more comprehensive interventions are needed in order to promote health among disadvantaged populations. In our practice, blepharitis is one of the more common eyelid abnormalities and one of the most difficult to treat. We introduce a new treatment that we have found to be helpful. A prospective study was devised to test its efficacy using 20 patients distributed randomly into three different treatment protocols. Our new protocol, using lyophilized collagen pads as adjunctive treatment, significantly improved results compared with controls. We had a 79% improvement in symptomatology and a 78% improvement in objective findings. To determine the effects of training on the quality of peer review.
                Single blind randomised controlled trial with two intervention groups receiving different types of training plus a control group.
                Reviewers at a general medical journal. Interventions Attendance at a training workshop or reception of a self taught training package focusing on what editors want from reviewers and how to critically appraise randomised controlled trials.
                Quality of reviews of three manuscripts sent to reviewers at four to six monthly intervals, evaluated using the validated review quality instrument; number of deliberate major errors identified; time taken to review the manuscripts; proportion recommending rejection of the manuscripts.
                Reviewers in the self taught group scored higher in review quality after training than did the control group (score 2.85 v 2.56; difference 0.29, 95% confidence interval 0.14 to 0.44; P = 0.001), but the difference was not of editorial significance and was not maintained in the long term. Both intervention groups identified significantly more major errors after training than did the control group (3.14 and 2.96 v 2.13; P < 0.001), and this remained significant after the reviewers' performance at baseline assessment was taken into account. The evidence for benefit of training was no longer apparent on further testing six months after the interventions. Training had no impact on the time taken to review the papers but was associated with an increased likelihood of recommending rejection (92% and 84% v 76%; P = 0.002).
                Short training packages have only a slight impact on the quality of peer review. The value of longer interventions needs to be assessed. Despite the growing number of studies of imagery and the use of complementary and alternative modalities as treatments for asthma, research on mental imagery in adults with asthma is practically, nonexistent. The purpose of this feasibility study was to lay groundwork for a larger follow-up clinical trial.
                To determine whether pulmonary function, asthma symptoms, quality of life, depression, anxiety, and power differ over time in adults with asthma who do and do not practice mental imagery (MI). (Power is the ability to make aware choices with the intention of freely involving oneself in creating desired change.)
                Randomized controlled study using univariate repeated measures analysis of variance (ANOVA) and replacement through block design.
                Lenox Hill Hospital, an affiliate of New York University Medical School, New York, NY.
                Sixty-eight adults with symptomatic asthma, after 4 weeks of baseline data collection and analysis, met requirements for this randomized controlled study. Thirty-three completed pulmonary function as well as self-report tests at 4 time points over 17 weeks. The 16 experimental participants also completed the 4-session imagery protocol.
                Individual imagery instruction (week 1) and follow-up (weeks 4, 9, 15). Participants were given 7 imagery exercises to select from and practice 3 times a day for a total of 15 minutes.
                1) Spirometry (FEV1); 2) medication use; 3) Asthma Quality of Life Questionnaire; 4) Beck Depression Inventory; 5) Spielberger Anxiety Scales (A-State and A-Trait); 6) Barrett Power as Knowing Participation in Change Tool, Version II; 7) Epstein Balloon Test of Ability to Image.
                There was little evidence of statistical change in this feasibility study; yet, valuable lessons were learned. Paired t-tests indicated there was a significant difference in the total power scores in the imagery group, and in the expected direction (two-tailed, t-statistic = -2.3, P = 0.035) and the choices sub-scale (two-tailed, tstatistic = -2.93, P = 0.01) of the power instrument from weeks one to 16 of the study. Eight of 17 (47%) participants in the MI group reduced or discontinued their medications. Three of 16 (19%) participants in the control group reduced their medications; none discontinued. Chi-square indicated differences between groups (X2 = 4.66, P = 0.05). Persons who reduced or discontinued their medications showed neither an increase in pulmonary function prior to medication discontinuation, nor a fall in these parameters following discontinuation.
                Findings related to major outcome measures must be viewed with caution due to the small sample size resulting from attrition related to labor intensiveness and, therefore, low statistical power. However, the study did provide significant data to plan a larger scale study of the use of mental imagery with adult asthmatics. The study also demonstrated that imagery is inexpensive, safe and, with training, can be used as an adjunct therapy by patients themselves. Its efficacy needs additional exploration. Further research for adults with asthma who practice imagery is important, as current treatments are not entirely efficacious. Lessons learned in this study may facilitate improvement in research designs. Randomized controlled trials (RCTs) of interventions provide the highest level of evidence about efficacy but their value either alone or within a meta-analysis is dependent on its methodological quality. For this reason recent RCTs in organ transplantation were assessed for quality. RCTs published between 2004 and 2006 (n = 332) were assessed, after excluding duplicate and nonEnglish reports. Quality was evaluated using the Jadad score plus allocation concealment and intention to treat analysis. We noted journal type, journal author instructions, funding source, sample size and number and location of study centres. Around one-third of RCTs had a Jadad score of 3 or greater (indication of a methodologically good quality trial) and the other two parameters were satisfied in just over one third. Although the majority of trials were published in speciality journals the quality of those published in general journals was superior. Commercially sponsored trials were of better quality as were multicentre trials in contrast to single centre trials. Overall quality of reporting of RCTs in organ transplantation is poor and as RCTs provide the highest level of evidence in evaluations of interventions there needs to be a concerted effort within the transplant community to improve the standards of RCTs. This study compared breakage and slippage rates of three male condom styles made of Tactylon(TM), a synthetic elastomer, to those of a marketed latex condom during vaginal intercourse. Safety and acceptability outcomes were also assessed. This two-center, prospective, crossover study enrolled 443 couples. Each couple was randomly assigned to use three condoms of each type in one of 24 use sequences. Couples completed questionnaires after using each condom, all of one condom type, and all four condom types. The percentage and standard error (SE, in parentheses) of latex condoms with clinical breakage was 0.86% (0.295). Percentages for Tactylon condoms were not equivalent to the latex study condom, ranging from 3.50% to 4.17%. The percentage and SE of latex condoms with complete slippage was 1.11% (0.328). Percentages for Tactylon condoms were equivalent to those for latex, ranging from 0.70% to 1.31%. The Low-Modulus Tactylon condom was the most preferred. Fewer medical events were reported with the Tactylon condoms than with the latex condom. It was concluded that Tactylon condoms were equivalent to the latex condom in terms of slippage but not breakage. However, safety and acceptability seemed to be better for Tactylon condoms. This may improve consistency of use and may attract new users.
Despite identifying 34 trials related to treatments for blepharitis, there is no strong evidence for any of the treatments in terms of curing chronic blepharitis. Commercial products are marketed to consumers and prescribed to patients without substantial evidence of effectiveness. Further research is needed to evaluate the effectiveness of such treatments. Any RCT designed for this purpose should separate participants by type of condition (e.g. staphylococcal blepharitis or MGD) in order to minimize imbalances between groups (type I errors) and to achieve statistical power for analyses (prevent type II errors). Medical interventions and commercial products should be compared with conventional lid hygiene measures, such as warm compresses and eyelid margin washing, to determine effectiveness, as well as head-to-head to show comparative effectiveness between treatments. Outcomes of interest should be patient-centered and measured using validated questionnaires or scales. It is important that participants be followed long-term, at least one year, to assess chronic outcomes properly.