There is a need for evidence of clinical effectiveness of foot orthosis therapy. This study evaluated the effect of foot orthoses made by ten podiatrists, ten pedorthists and eleven orthotists on plantar pressure and walking convenience for three patients with metatarsalgia. Aims were to assess differences and variability between and within the disciplines. The relationship between the importance of pressure reduction and the effect on peak pressure was also evaluated.Each therapist examined all three patients and was asked to rate the 'importance of pressure reduction' through a visual analogue scale. The orthoses were evaluated twice in two sessions while the patient walked on a treadmill. Plantar pressures were recorded with an in-sole measuring system. Patients scored walking convenience per orthosis. The effects of the orthoses on peak pressure reduction were calculated for the whole plantar surface of the forefoot and six regions: big toe and metatarsal one to five.Within each discipline there was an extensive variation in construction of the orthoses and achieved peak pressure reductions. Pedorthists and orthotists achieved greater maximal peak pressure reductions calculated over the whole forefoot than podiatrists: 960, 1020 and 750 kPa, respectively (p < .001). This was also true for the effect in the regions with the highest baseline peak pressures and walking convenience rated by patients A and B. There was a weak relationship between the 'importance of pressure reduction' and the achieved pressure reduction for orthotists, but no relationship for podiatrists and pedorthotists.The large variation for various aspects of foot orthoses therapy raises questions about a consistent use of concepts for pressures management within the professional groups. A variety of foot impairments such as rheumatoid arthritis and diabetes are associated with elevated plantar forefoot peak pressures and metatarsalgia. ReductiDutch medical specialists and general practitioners prescribe foot orthoses which are mainly provided by podiatrists, pedorthists (orthopaedic shoemaker) and orthotists (orthopaedic technician). These disciplines have separate vocational training. They differ regarding diagnostic procedures, construction of orthoses and therapeutic approach e.g.: pedorthists are specialized in foot orthosis therapy for orthopaedic shoe wear, whereas podiatrists and orthotists mainly provide foot orthoses for non-orthopaedic shoe wear. In general, orthotists take care of more severe disorders than podiatrists. AlthougAs representatives of their professional groups, ten podiatrists, ten pedorthists and eleven orthotists from the southern part of The Netherlands were asked to construct foot orthoses for three patients with metatarsalgia and elevated forefoot peak pressure. Podiatrists were approached through telephone directories. Companies of pedorthists and orthotic workshops were approached through member lists of the professional associations. Each delegated between one and three therapists for the study. The median professional experience in years was 7.5; 16.5 and 20, respectively for podiatrists, pedorthists and orthotists.Three patients, 2 females of 60 and 61 years old and a 37 years old male, with forefoot complaints, elevated plantar peak pressures and an indication for foot orthoses were selected from an orthopaedic outpatient clinic. The male patient had foot problems related to psoriatic arthritis, which was inactive during the study period. The specific diagnosis for both female patients was bilateral metatarsalgia due to overloading of the forefoot as consequence of structural defects  was used to measure plantar pressures[®' software[Per patient 31 pairs of foot orthoses were evaluated twice in two sessions. Two pairs of sham orthoses were added to create eleven blocks of three pair of orthoses, one from each discipline. The blocks were randomized to determine the measurement sequence and this sequence was reversed for the second session. All orthoses were evaluated in the patient's own shoes and wearing standard thin socks while walking on a treadmill. The Pedar Insole-systempressures,27. The  software. BaselinDifferences in plantar pressure reduction amongst the professional groups were evaluated for the region with the highest peak pressure measured under the forefoot without orthosis table . For patVariance of the maximal pressure reduction was used to show the within-group variation and to test for equality of these within group variations between the three disciplines. For this purpose a homogeneity of variance analysis was performed with a repeated measures ANOVA, using the GENOVA computer program.® software (SPSS Inc.). An alpha level of 0.05 was chosen to judge statistical significance.For the assessment of the relationship between achieved pressure reduction and 'importance of pressure reduction' we used the maximal pressure reduction. For this purpose linear regression analysis was performed for the cases were there was a wide distribution of the 'importance of pressure reduction' ratings. Statistical analysis was carried out with SPSS 12.01Orthoses made by podiatrists clearly differ from orthoses from pedorthists and orthotists. All podiatrists constructed thin insoles out of rubber, leather and cork, but they varied in the application of corrective and/or supportive elements. In broad outlines, orthoses of pedorthists and orthotists were similar. The pedorthists and orthotists made orthoses that look more like the 'Root style' orthoses,30. HoweFor all three patients, the changes of the plantar pressure measurements without orthoses, from before to after the test series, were very small. The change during session 1 for patient A was 0.4, patient B -4.5, patient C 5.1 kPa. During session 2: patient A -0.3, patient B -4.3, patient C -2.1 kPa. We concluded that there was no relevant effect of fatigue on peak pressures in the course of the measurement sessions.Results for each region for pair wise statistical testing are listed in the figure The highest baseline peak pressures for patient B were measured in both mt-3 regions table . OrthotiThe highest baseline peak pressures for patient C were also measured in both mt-3 regions table . OrthoseFor patient B and C, a high peak pressure was measured in the corresponding right and left BT region table . OrthoseThe maximal reduction of peak pressure calculated for the whole plantar surface over all forefeet was greater with orthoses of pedorthists (p = .005) and orthotists (p < .001) than orthoses of podiatrists: -96 and -102 versus -75 kPa respectively. The within-group variability, expressed as standard deviation, of the maximal local peak pressure reduction for the whole forefoot were 16.0, 14.2 and 16.3 kPa for podiatrists, pedorthists and orthotists respectively  and 48% (p = .019) of the variance of the effect on peak pressure, respectively figure . There wPodiatrists had less years of professional experience than pedorthists (p = .037) and orthotists (p = .008), while orthotists and pedorthists did not differ in years professional experience. Multiple regression analysis showed that there was no, or a very weak, relationship between achieved pressure reduction and years professional experience, number of constructed orthoses per week, or importance of pressure reduction (data not shown).The appreciation of walking convenience by the patients is shown in table We studied the effect of 186 custom-made foot orthoses  made by podiatrists, pedorthists and orthotists on plantar pressure and walking convenience for three patients with elevated forefoot peak pressures and metatarsalgia. Within the three disciplines there was a large variation in construction of the orthoses and achieved peak pressure reductions. On average, the pedorthists and orthotists achieved slightly greater pressure reductions and a better walking convenience than podiatrists.In accordance with what was reported in other studies, it turned out to be impossible to categorize the constructed orthoses in general orthotic classifications, such as 'functional' or 'accommodative'. TherefoWe assessed the pressure reduction effect of orthoses for the region with the largest peak pressure. This is where the largest effects should be achieved. In general, pedorthists and orthotists achieve greater reductions, than podiatrists. However, these differences in peak pressure reductions between podiatrists versus pedorthists and orthotists were statistically significant for only one of the patients. In addition, the maximal local reduction of peak pressure calculated for the whole plantar surface over all forefeet was statistically significantly greater with orthoses of pedorthists and orthotists than orthoses of podiatrists.In one of the patients, at the location of the highest baseline peak pressure, the podiatric orthoses even resulted in a increase of the peak pressure. Such an increase of plantar pressure could be dangerous, especially in neuropathic feet,40.According to the ratings for 'importance of pressure reduction', optimizing pressure distribution was a main treatment goal for most therapists figure . HoweverWalking convenience is important for the patient's preference and acceptance of an orthosis for daily use. Two patients scored walking convenience better for orthoses of pedorthists and orthotists compared to orthoses of podiatrists. For patient C there were no clear differences. However, because walking convenience was judged immediately after the measurement session, it remains unclear whether the patient's preference will stay the same after getting used to the orthosis.The general theoretical and practical concepts of foot orthoses therapy should be common to the therapists of each discipline concerned. The situation in the Netherlands for establishing this professional uniformity is optimal because there is only one school for each discipline. Nevertheless, there is a large variation in orthoses construction and treatment effects within each discipline, while there were no differences in the variation in effect on peak pressure among the three disciplines.We evaluated the effects of foot orthoses therapy on plantar pressure and walking convenience for only three patients. We did not set out to examine patient-specific therapy outcome. Although the effects of orthoses for patients with other foot pathologies and plantar pressure patterns could be different, we see no reasons why the differences between the professional groups and the variation within professional groups would be substantially different for other patients. We are of the opinion that the therapists who participated in our study are a fair representation of their national colleagues. There could even be some underestimation of the variation within professional groups because some of the therapists work within the same company.Variation in plantar pressure management could be the result of inconsistent application of diagnostic procedures, of setting treatment goals and methods of constructing orthoses. In a previous study we indeed showed that therapists often disagree about the locations with high plantar pressures. InformaWe showed a large variation among therapists for the Dutch situation. It is difficult to say whether these results can be generalised to professional groups in other countries. However, we do not know of any study showing that the situation is better elsewhere. Insofar as variation has been studied, specific aspects like diagnostic procedures and orthoses prescription show similar variability problems,23,44-52This study showed differences between three disciplines that construct custom foot orthoses for patients in The Netherlands with respect to construction, presumed importance of plantar pressure reduction, achieved pressure reduction and walking convenience. On average, pedorthists and orthotists achieved a slightly larger pressure reduction in high peak pressure regions and a better walking convenience than podiatrists did. There was a weak relationship between the 'importance of pressure reduction' and the achieved pressure reduction for orthotists, but no relationship for podiatrists and orthotists. The large variation in construction of the orthoses and in peak pressure reduction within the professional groups raises questions about a consistent application of therapeutic concepts for the management of elevated peak pressures.A better understanding of and consensus about the mechanisms underpinning the effectiveness of foot orthoses therapy is needed in order to improve foot orthoses therapy, This must lead to unambiguous guidelines that enable improved education and consequently less variation between therapists.The author(s) declare that they have no competing interests.All authors designed the study. NG collected and prepared the data. NG, PL and FN analyzed the data. All authors interpreted and discussed the data. NG, PL and GW drafted the manuscript. NA and PL revised the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:


Rupture of a renal artery aneurysm (RAA) during pregnancy is a rare event, with a high mortality rate for both mother and fetus. Increased blood flow and intra-abdominal pressure, and vascular changes secondary to increased steroid production are postulated as contributory to the increased risk of rupture during pregnancy.We present here a case report of total avulsion of solitary kidney secondary to rupture of RAA in a pregnant patient with congenital absence of the contralateral kidney. The main indication for nephrectomy was severely damaged kidney. Diagnosis was made during operation and both mother and fetus were saved. There are no previous reports of an intact renal artery aneurysm diagnosed either antepartum or postpartum.The possibility of a ruptured RAA should be considered in pregnant women with evidence of retroperitoneal hemorrhage. This case was unusual because it occurred in a solitary kidney, during the third trimester of pregnancy. Renal artery aneurysm (RAA) occurs due to focal dilatation of the artery secondary to weakness of the arterial intima and media. In most of the cases it is present as a small (1–2 cm) and unilateral one. Renal artery aneurysm is a rare clinical entity with an incidence of 0.015–1%. The aetiology of RAA is either, congenital or acquired secondary to atherosclerosis, malignancy, etc. Solitary kidney is an abnormally heavy one, due to compensatory hypertrophy and also it is more liable to have other congenital anomalies like RAA. Rupture or total avulsion of the kidney secondary to rupture RAA during pregnancy is an extremely rare event, even more the obstetric and urological literatures are Deficient in this regard. Predisposing factors of rupture RAA are, incomplete calcification, size > 2 cm, and presence of hypertension and if pregnancy co-exists. Diagnosis of rupture RAA during pregnancy is very difficult as there is no path gnomonic pain or presentation. When rupture occurs during pregnancy the clinical presentation is easy to be confused with those more common conditions like placental abruption or rupture uterus. Most of the cases are discovered incidentally; even sometimes it is only diagnosed after autopsy. When rupture RAA occurs during pregnancy it carries a high fatality or poor feto-maternal outcomes. When RAA is diagnosed during pregnancy the treatment modalities, are conservative if non calcified and small < 2 cm or aneurismal resection and vascular reconstruction, end to end anastomosis or nephrectomy if the patients has extensive renal injury or haemodynamically unstable or it is usually done as a life saving procedure.A 40 year old woman, gravida 10 para 9, unbooked, presented to the emergency room, severely ill, complaining of severe acute abdominal pain since 1 hour. According to her given expected date of confinement, she was 35 weeks and four days of gestation. On admission, she had no history of medical disorders or trauma. Generally, she was very pale, conscious, agitated, hypotensive and with severe tachycardia . Abdominally, marked tenderness and rigidity all over the abdomen was found, fetal heart sounds showed severe bradycardia 100/bpm. Vaginal examination revealed no bleeding and the cervix was closed, firm and posterior. Laboratory studies, included a complete blood cell count, chemistry, coagulation profile, and arterial blood gases, were undertaken. In view of her clinical presentation, as BP was decreasing and the pulse was increasing, the provisional diagnosis was query placental abruption or rupture uterus. Rapid infusion of 2 L of crystalloid was started. Cesarean section was done immediately, there was no signs of placental abruption as the placenta was upper, posterior and fully attached to the uterine wall. She gave birth of a baby boy (2.2 Kg), Apgar score , admitted to the NICO. After closure of the uterus, the pelvis and abdomen were explored. A huge retroperitoneal haematoma was found extending behind the descending colon. The general and vascular surgeons were called, they advised conservative treatment as the haematoma was neither expanding nor pulsating. The abdomen was closed and 2 intra-peritoneal drains were left. During the operation she received 4 units FFP, 2 units blood 4 units of packed cells and remained haemodynamically stable. The patient was kept in recovery room for close monitoring. Within one hour BP dropped again to 100/60 mm Hg, pulse increased to 110/bpm, blood was coming from the drains and the patient was deteriorating. Both surgeons were called again for re-assessment; they decided to re-explore the abdomen. The retroperitoneal haematoma was found to be expanded via the left paracolic gutter, the posterior peritoneum over the haematoma was opened. A voluminous retroperitoneal haematoma (about 3000 ml blood and clot), due to an undiagnosed totally avulsed left kidney, was found. There was severe bleeding from the hilar vessels. The bleeding vessels were clamped and the urologist was called and shared the operating team. A decision of nephrectomy was taken, after a committee, as the left kidney was severely damaged and as a life saving procedure. The urologist tried to feel the other kidney but he failed because of the extensive haematoma. During re-exploration she received, 6 units packed cells, 6 units FFP and IV fluids. After closure of the abdomen the patient was found to be anuric. The urologist preferred to do cystoscopic examination versus right ureteric catheterization but he failed to visualize the right ureteric orifice. Abdominal and pelvic ultrasound was done at the theatre and failed to visualize the right kidney. The patient was transferred to ICU, anuric, under sedation on ventilator. She stayed anuric for 2 days in the ICU, after that she was transferred to the postoperative ward. Her postpartum recovery was uneventful apart from progressively increasing kidney function tests. CT was done in the second postoperative day and confirmed the absence of right kidney. She was discharged after 10 days from admission and a haemodialysis twice sitting per week was scheduled for her. The patient now is waiting for compatible kidney transplant. Histopathological report revealed degenerative aneurysmal changes of the renal artery and acute tubular necrosis of the left kidney.We reported on a pregnant patient at 35 weeks of gestation, who had total avulsion of a solitary kidney secondary to spontaneous rupture of RAA, treated by nephrectomy with favorable outcomes.To our knowledge this is the first case report in the literature, of total avulsion of a solitary kidney late in pregnancy.The natural history of the RAA, is not known with certainty, but it has potential complications including embolization and rupture . Renal aPrior to 1970, reported rupture of RAA occurred most often on the left side, during the third trimester, and was associated with a 92% maternal mortality and a 100% fetal mortality rate. Since 1970, published reports have not shown a left-sided predominance, and survival after this catastrophic event has greatly improved, even though preoperative diagnosis is still rare .Twenty six cases of RAA during pregnancy have been reported in the English medical literature. Renal salvage with in situ repair of the renal artery has been documented in only four cases, and successful ex situ repair and auto transplantation in only two cases ,7,8.There are no previous reports of diagnosis of an intact RAA during pregnancy and only one postpartum case was diagnosed and treated successfully by Pliskin et al. . They reMartin et al. , reporteThe clinical presentation of our case was easily confused with those more common conditions, as she was thought to have either a placental abruption or ruptured uterus. Satoh et al. , reporteDuring re-exploration the urologist failed to palpate the contralateral kidney from the extensive retroperitoneal haematoma she had. Dayton et al. , reporteSpontaneous rupture of RAA is more likely to occur during pregnancy and when it does, there is an associated high mortality for the mother and fetus. Increased blood flow and intra-abdominal pressure, and vascular changes secondary to increased steroid production are postulated as contributory to the increased risk of rupture of RAA during pregnancy .Dancing effect), make the kidney more liable to injury during pregnancy. Franz et al. [In a trial to solve the puzzle, what are the causes of total avulsion of the kidney in the current pregnancy? We proposed the following: (1) Our patient was grand multipara, and it is well known that, every single pregnancy does anatomical and physiological changes in the kidney. (2) The physiological changes gave the impression of obstructive uropathy. (3) Solitary kidney, is an abnormally heavy one, due to compensatory hypertrophy and also it is more liable to have other congenital anomalies like RAA. (4) The effect of hyperdynamic circulation on an already existing RAA together with an abnormal solitary kidney. (5) The resultant increase intra-ureteral pressure acts as an axis, in addition, to the presence of an abnormal heavy kidney  and in aneurysms exceeding 2 cm in diameter ,14.Lumsden et al. , concludThe possibility of a ruptured RAA and/or kidney, should be considered in pregnant women with evidence of retroperitoneal hemorrhage. This case was unique because, the spontaneous rupture of RAA resulted in total avulsion of the solitary kidney.The author(s) declare that they have no competing interests.Khaled B. Soliman. MT, FG Yaser Shawky., FG Mohamed M. Abbas., FG Mohamed Ammary. FG, Allaa Shaaban. FG. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:


Among patients with hypertension, those with established left ventricular hypertrophy (LVH) represent a high risk cohort with poor prognosis. We aimed to investigate differences in characteristics and health care management of such patients treated as inpatients or outpatients by cardiac specialists.Prospective cross-sectional study in patients with hypertension and LVH who were referred to either inpatient care  or to outpatient care (cardiology practices).A total of 6358 inpatients  and 2246 outpatients  were followed up for a mean of 23 vs. 52 days, respectively. Inpatients compared to outpatients had a significantly higher prevalence of coronary heart disease, history of stroke, renal failure or diabetes. Mean blood pressure of inpatients compared to outpatients was significantly lower both at entry (150/84 vs. 161/93 mmHg) and at end of follow-up (129/75 vs. 139/83 mmHg). After adjustment for baseline blood pressure and a propensity score, differences between out- and inpatients at end of follow-up were 8.0/5.1 mmHg in favour of inpatients. Blood pressure goals as specified by guidelines were not met by 32% of inpatients and 55% of outpatients.Inpatients had a higher rate of comorbidities and more advanced atherosclerotic disease than outpatients. Control of hypertension of inpatients was already better on admission than in outpatients, and treatment intensity in this group was also higher during the observation period. While blood pressure lowering was substantial in both groups, there were still a high proportion of patients who did not achieve treatment goals at discharge. Cardiovascular (CV) diseases such as coronary heart disease, heart failure and stroke are the leading causes of death in industrialized nations,2. From In order to promote evidence-based therapy for hypertension, a number of guidelines have been issued by national and international societies, -9 and suThese studies addressed the situation in the community or in the primary care setting. Specialist care might be better than care from general practitioners . The GerAnother option for specialist care is provided in an outpatient setting. Primary care physicians may refer patients with high CV risk – independent of a previous CV event – to a cardiac specialist in an outpatient setting for diagnostic and therapeutic support and risk stratification.To date it has not been investigated whether patients referred to cardiac specialists in an inpatient versus an outpatient setting differ from each other in terms of demographics or comorbidities, are treated differently, or have different outcomes. Therefore we addressed these questions in a large-scale prospective study. We focused on hypertensive patients with comorbid LVH as high risk group easily identified by cardiac specialists, with high prevalence and thus substantial public health implication.This was an observational epidemiological prospective study , performed between September 2002 and January 2003 in a convenience sample of cardiac experts throughout Germany. A total of 251 certified cardiologists (treating outpatients only) participated, as well as 100 rehabilitation centers that specialized on the management of patients with CV diseases (and recruiting inpatients only). They documented a total of 12 273 patients who met the entry criteria. Of those, 7 095 (58%) were from inpatient facilities and 5 178 (42%) were from outpatient practices.Male and female patients were eligible for inclusion in the present analysis, if they were aged 18 years or older, had a physician diagnosis of arterial hypertension and concomitant LVH, provided informed consent and if their clinical follow-up duration was scheduled to be at least 3 days. LVH was assessed according to standard criteria in the electrocardiogram , in the echocardiography or both -20. No fTwo visits were foreseen, on admission and at discharge, to document patient data on case report forms. The schedule according to which outpatients were followed up was not regulated in the study protocol but left to the physicians in order to demonstrate real life patient care. Physicians in both settings recorded demographic data, medical history, details on cardiovascular risk factors and comorbidities, results of physical examination, laboratory and procedural test results, medications and the dosages of their patients. Reasons for the initiation of antihypertensive drugs and any changes in medications were noted. Blood pressure was recorded by trained nurses with a certified device on admission and at discharge with the patient sitting for at least 3 minutes. The blood pressure at the fifth Korotkoff sound was taken as the diastolic pressure. Heart failure was diagnosed with standard clinical methods detailed elsewhere . The docData were stored in a Microsoft Access 97 database and analyzed with the SAS statistical program (release 8.2), SPSS (release 13.0) or SYSTAT (release 11.0), respectively. Descriptive statistics were derived and comparisons between inpatients and outpatients were conducted by t-tests or chi square tests as appropriate. Significance was accepted at the p < 0.05 level. Furthermore, local regression lines (LOWESS regressions) were com2.8604 of the recruited patients met the hypertension/LVH criteria, namely 6358 (74%) inpatients and 2246 (26%) outpatients. In terms of demographics, there were no major differences between groups. Inpatients had a mean age of 66.6 (± 12.1) years, and 59.6% were male; outpatients were 63.2 (± 11.3) years of age; and 59.7% were male. In both cohorts, mean BMI was 28.2 kg/mAlmost all patients (99%) were currently hypertensive and all had LVH. In 70%, LVH diagnosis was established with echocardiography, in 8% with electrocardiography, and in the remainder with both procedures. Additional risk factors, target organ damage and atherosclerotic manifestations were highly prevalent in both groups, as presented in Figure Twenty-two baseline characteristics contributed to the propensity score. Of these, 4 variables accounted for 85% of the variation in the propensity score: abnormal renal function, diastolic and systolic blood pressure and family history for hypertension. After adjustment for the score, 21 out of the 22 baseline variables were not significantly different between groups, indicating that the propensity score explained the referral effects rather well.Inpatients were discharged after a mean of 23 days (3.3 weeks), outpatients were followed up over a mean of 52 days (7.4 weeks), and then referred back to primary care.Mean blood pressure (BP) values on admission was 150.5/84.4 mmHg for inpatients and thus substantially lower than in outpatients . BP goals at admission (defined as systolic/diastolic BP < 140/90) were not met in 72% of inpatients and 92% of outpatients, respectively, as displayed in Figure Figure Drug treatment rates increased between the beginning and end of the survey from 91% to 98% in inpatients and from 88% to 95% in outpatients. Figure 1 blockers in this group. In total, the prescription rates of inhibitors of the renin-angiotensin system were increased in both groups at discharge.On admission, conventional drugs  were most frequently prescribed. Usage of all drug classes was increased at discharge, with the exception of ACE inhibitors that were reduced in outpatients. However, this was compensated for by a substantial increase in ATNumerous medication changes were made in both individual inpatients and outpatients, and in only 25% (inpatients) and 21% (outpatients) medications at entry were maintained without any changes. Table The present study was conducted to assess whether high-risk patients (hypertensive with LVH) treated by cardiac specialists in the community setting (outpatients) differ from patients treated by specialists in cardiac rehabilitation centers (inpatients) in terms of patient characteristics and comorbidities, process of care, and clinical outcomes. The principle findings of the study are as follows: First, inpatients had a higher rate of comorbidities and more advanced atherosclerotic disease. Second, control of hypertension of inpatients was already better on admission than in outpatients, and treatment intensity in this group was also higher during the observation period. Third, while blood pressure lowering was substantial in both groups, there were still a high proportion of patients that did not achieve treatment goals at discharge.Current guidelines for the management of hypertension such as the one of the European Hypertension Society/European Society of Cardiology stress the importance of searching for comorbidities , as they substantially influence prognosis of the patient . These a1 blockers in patients with LVH [The present study focused primarily on LVH as this condition in cardiac specialist care, when diagnosed, should trigger intensive blood lowering treatment. This approach is clearly evidence-based, as a number of studies have documented substantial, however variably strong, regression of LVH with various antihypertensive drugs . The larwith LVH .Our study found that hypertensive patients with LVH when referred as inpatients were generally sicker than outpatients when taking into account comorbidities . Obviously, referring primary care physicians trust that these patients will benefit from the characteristics of an inpatient setting .1 receptor blockers were much more frequently used in outpatients than in inpatients (54% versus 37%), whereas the opposite held true for ACE inhibitors (66% versus 37%). Potential reasons for this difference might include cost considerations. Interestingly outpatients seemed more difficult to manage, as they had much higher medication switch rates with lack of tolerability being three-fold increased compared to inpatients, and lack of compliance being substantially increased. It is known from the controlled study setting [1 blockers seem to be associated under study as well as clinical practice conditions with better tolerability and consequently, higher persistence rates among treated patients [1 receptor blockers were preferred in outpatients. Nonetheless, previous reports from the primary care setting suggest that there is wide-spread reluctance of physicians to treat hypertension aggressively enough. Underlying reasons might be, at least in the elderly, the fear of doing harm by applying too-intensive treatment [Regarding general hypertension management and medication choice, cardiac specialists treating inpatients or outpatients seemed to follow guideline recommendations to a substantial extent. Antihypertensive treatment during the observation was intensified, as evidenced by the increased proportion of medically treated patients, by the increased number of drugs (2.5 at the discharge), and the preference of inhibitors of the renin angiotensin system. The LOWESS regression suggests that inpatients were somewhat more aggressively treated than outpatients; however, this was seen only in patients with SBP values above 160 mmHg. Notably, AT setting  as well  setting ,28. All patients ,29. Thisreatment , and as reatment . "Clinicreatment , may alsreatment . Reimburreatment ) may alsIn terms of treatment outcomes, the mean absolute BP lowering effect achieved was substantial in both groups . In a recent metaanalysis of 354 randomised controlled trials including all current first-line antihypertensives, the mean BP lowering effect across all drug classes in the standard doses was SBP/DBP -9.1/-5.5 mmHg . Thus, eThe general BP target of <140/90 mmHg were achieved by inpatients more frequently than by outpatients. This might be due to the fact that outpatient practitioners had to manage higher blood pressures at entry. However, even with comparable baseline values, in the inpatient setting more pronounced blood pressure reductions were achieved in the outpatient setting. While control rates as such in both groups were suboptimal, it has to be stressed that physicians had to treat "difficult" patients with multiple comorbidities within the constrictions of a challenging time frame.The present study was not designed to answer the question whether cardiac specialists in the hospital setting compared to those in the community setting provide better care for patients. A number of studies compared certified cardiologist care with internists or primary care physicians, and found improved care for cardiology conditions, mainly in the treatment of patients with acute myocardial infarction or heart failure -43. HoweWe found that high-risk hypertensive patients with LVH treated as inpatients versus as outpatients differed in terms of their profiles, and comorbidities. While their blood pressure treatment is intensified by cardiac specialists in both settings, there is still substantial room for improvement in blood pressure and corresponding risk reduction. There was a substantial gap in blood pressure control rates to published targets. This data confirm the difficulties reported in achieving treatment goals in other settings and indications. As the results are more than three years old, a similar study should be initiated shortly to assess whether the situation has improved.KB is as Director of Medical Research employed by MSD Sharp&Dohme GmbH, Haar, Germany, and is also affiliated with the Institute for Clinical Pharmacology, Technical University of Dresden. All other authors declare that they have no competing interests. MSD funded the study with an educational grant and covered the publication costs.HV and KB designed the study, SF, JT, and FCL were advisors to study design and interpretation of the study, KW was the statistical advisor and performed all analyses. KB and HV wrote the first draft of the manuscript, and all authors contributed to the revisions and gave their consent to the final manuscript.The pre-publication history for this paper can be accessed here:


Non-invasive assessment of arterial pressure wave forms using applanation tonometry of the radial or carotid arteries can be technically challenging and has not found wide clinical application. 2D imaging of the common carotid arteries is routinely used and we sought to determine whether arterial waveform measurements could be derived from tissue Doppler imaging (TDI) of the carotid artery.We studied 91 subjects  with and without cardiovascular disease. Tonometry was performed on the carotid artery simultaneously with pulsed wave Doppler of the LVOT and acquired digitally. Longitudinal 2D images of the common carotid artery with and without TDI were also acquired digitally and both TDI and tonometry were calibrated using mean and diastolic cuff pressure and analysed off line.Correlation between central pressure by TDI and tonometry was excellent for maximum pressure . The mean differences between central pressures derived by TDI and tonometry were minimal .Imaging of the common carotid artery motion with tissue Doppler may permit acquisition of a waveform analogous to that from tonometry. This method may simplify estimation of central arterial pressure and calculation of total arterial compliance. Blood pressure has been shown to be a strong predictor of cardiovascular risk–increased systolic blood pressure (SBP) reflecting stiffening of the arterial walls and changes in vascular structure, and increased pulse pressure (PP) reflecting stiffening of conduit vessels ,2. ArterIn contrast, carotid imaging is very familiar. Assessment of carotid intima-media thickness (IMT) is well established ,9, has bWe studied 91 subjects  with and without cardiovascular disease. Of these patients, 33 were normal controls (NL), 28 were patients with isolated systolic hypertension (HTN), 10 were normotensive patients with diabetes mellitus (DM), 10 were patients with systolic heart failure (CHF), and 10 were patients who had undergone renal transplantation (RT). Clinical data, blood pressure, and cardiovascular risk factors were gathered and all patients were then studied with simultaneous applanation tonometry and pulsed-wave Doppler and then had 2D ultrasound and tissue Doppler performed on their carotid artery.Applanation tonometry was performed on the right carotid artery in all patients after they had been allowed to rest for 5–10 minutes. Tonometry uses a transcutaneously applied, micro-manometer-tipped probe which is placed against an arterial wall. Application of sufficient pressure to distort, or applanate the artery creates a signal which approximates instantaneous arterial pressure  was derived using the pulse pressure method, using a combination of stroke volume (derived by echocardiography from the dimensions and pulsed-wave Doppler measurement of flow in the left ventricular outflow tract (LVOT)) and the pressure waveform obtained from applanation tonometry of the radial artery . These wFor calculation of total arterial compliance, the binary files were processed and analyzed using a custom analysis program written in MatLab 4. Between five and ten cardiac cycles of tonometry and Doppler were chosen from the raw dataset based on data quality and averaged for analysis. With the use of cursors to identify the beginning and end of aortic ejection, peak ejection, and peak pulse pressure on both the reconstructed Doppler and central pressure waveforms, the analysis program determined mean values for pressure and flow and calculated a mean aortic pressure figure . Based oThe carotid arteries were scanned longitudinally in the anterior, lateral and posterior aspects 2–10 cm below the bifurcation, and digital cine loops are acquired for offline analysis. The image was then optimized for TDI using the smallest possible region of interest (ROI) box to achieve the highest frame rate, which was usually between 160–220 frames per second. The 2D and color Doppler settings were also customized for extraction of vessel displacement: for 2D imaging – dynamic range of 150 dB, the 2D option is set to penetration, persistence is set at low and frame rate is set at maximum; for the color tissue Doppler – the gain was set at 100%, with a PRF of >200 Hz. Care was taken not to include any discrete plaques in the tissue Doppler measurements. Loops of 3–5 cardiac cycles with TDI were then acquired digitally for offline analysis  which extracts the velocity information for the ROI area over the cardiac cycle, and with a processing algorithm, generates values for vessel wall displacement (in microns) over time . These dBoth the extracted TDI displacement curves and the tonometric curves were then imported into a custom written MatLab program for analysis and once calibrated, a comparison was done between the waveforms figure . CarotidPearson's correlation was used to determine the concordance between central pressure determined by TDI and by tonometry, paired t-tests were used to determine the mean differences between the two techniques and Bland-Altman analysis was used to determine the differences from the mean for central pressure between the two techniques.Table Correlation between central pressure by TDI and tonometry was excellent for maximum pressure . In paired t-tests the mean differences between central pressures derived by the two techniques was minimal, although there was a 5 mmHg difference between maximum pressure derived by TDI and tonometry table . Bland-ABecause of the calibration with mean and diastolic pressure, only maximum pressure was compared in a subgroup analysis. The HTN group had the highest maximum pressure and the CHF patients had the lowest pressure, as would be expected. The controls, DM group and RT groups all had maximum pressure within a normal range. In paired t-tests comparing the TDI and tonometry the HTN group had the highest paired difference  and the controls had the smallest paired difference  table .The TDI technique underestimated systolic pressure in about a third of cases resulting in a higher than acceptable difference in the Bland-Altman analysis. The causes of this appear to be related to inappropriate TDI settings and other technical problems, and therefore this may be avoided with experience and guidelines. Failure to use a sufficiently high pulse repetition frequency caused aliasing of the velocity signals and the resulting displacement waveforms and calibration by the technique described above produced a pressure waveform which does not reflect accurate maximum pressure when compared to the carotid tonometry in several cases Figure . ExcessiThe results of this study suggest that carotid TDI can be used to approximate central blood pressure and that the resulting waveform is analogous to that obtained with applanation tonometry. This would obviate the need for a transfer function and the waveform could be used to calculate total arterial compliance from central rather than peripheral pressure. The advantage of TDI imaging is that vascular imaging is available, feasible in a clinical setting, and can be incorporated into any cardiovascular imaging examination without extra equipment.Total arterial compliance is reduced with age, vascular disease and hypertension -21, and While brachial blood pressure has been shown to be a strong predictor of cardiovascular morbidity, mortality and outcome ,22,34,35While applanation tonometry is considered the "gold standard" for use in assessing arterial stiffness it is not without limitations. The major limitation of pressure measurement with tonometry is the use of brachial cuff pressure to calibrate the signals. Past studies have shown poor inter-observer variability in taking brachial pressure and a poor correlation between reported and actual pressure ,39. OperThe results of this study suggest that tissue Doppler may be useful in assessing central arterial pressure and in the estimation of total arterial compliance. Carotid imaging for IMT is familiar and feasible and has already been incorporated into many cardiovascular imaging laboratories. The use of the same imaging test to obtain arterial waveforms could enhance the evaluation of carotid IMT with information about arterial function as well. In addition, calibration of the arterial displacement waveforms obtained from TDI may simplify the estimation of total arterial compliance and alleviate the technical considerations of tonometry.The author(s) declare that they have no competing interests.BAH conceived the study design, gathered and analyzed the data, interpreted the results and drafted the manuscriptLJ assisted in gathering the tonometry and TDI dataPMM assisted in gathering the carotid tonometry and in recruiting patients for the study.SGC developed the acquisition and analysis software for the tonometry and wrote the analysis program to compare the tonometry and TDITHM was instrumental in study design and implementation, helped to interpret the results and edited the final manuscript


Poor adherence is one of the biggest obstacles in therapeutic control of high blood pressure. The objectives of this study were (i) to measure adherence to antihypertensive therapy in a representative sample of the hypertensive Pakistani population and (ii) to investigate the factors associated with adherence in the studied population.P<0.02) and whether he/she was taking medication regularly or only for symptomatic relief (P<0.00001).A cross-sectional study was conducted on a simple random sample of 460 patients at the Aga Khan University Hospital (AKUH) and National Institute of Cardiovascular Diseases, Karachi, from September 2005–May 2006. Adherence was assessed using the Morisky Medication Adherence Scale (MMAS), with scores ranging from 0 (non-adherent) to 4 (adherent). In addition to MMAS, patient self-reports about the number of pills taken over a prescribed period were used to estimate adherence as a percentage. AKU Anxiety and Depression Scale (AKU-ADS) was incorporated to find any association between depression and adherence. At a cut-off value of 80%, 77% of the cases were adherent. Upon univariate analyses, increasing age, better awareness and increasing number of pills prescribed significantly improved adherence, while depression showed no association. Significant associations, upon multivariate analyses, included number of drugs that a patient was taking (Similar to what has been reported worldwide, younger age, poor awareness, and symptomatic treatment adversely affected adherence to antihypertensive medication in our population. In contrast, monotherapy reduced adherence, whereas psychosocial factors such as depression showed no association. These findings may be used to identify the subset of population at risk of low adherence who should be targeted for interventions to achieve better blood pressure control and hence prevent complications. Hypertension is an overwhelming global challenge which ranks third as a cause of disability-adjusted life-years The National Health Survey of Pakistan (NHSP), conducted from 1990 to 1994, showed that hypertension affects 18% of adolescents above 15 years of age and 33% of adults above 45 years of age; less than 3% hypertensive patients, however, have their BP controlled to 140/90 mm Hg or below and more than 70% of all hypertensive patients  in Pakistan are not even aware of their disease Studies worldwide indicate that despite the availability of effective medical therapy, over half of all hypertensives do not take any treatment It has been well documented that uncontrolled blood pressure increases the risk of ischemic heart disease 3-to 4-fold Adherence is defined by WHO as “the extent to which a person's behavior–taking medication, following a diet, and/or executing lifestyle changes-corresponds with agreed recommendations from a health care provider” We undertook this research with the objectives of (i) measuring adherence through the use of validated tools and (ii) investigating the demographic, social and personal factors affecting patient adherence to antihypertensive therapy in the Pakistani population.This descriptive study was a questionnaire-based cross sectional analysis. A simple random sample of 460 patients was selected between September 2005 and May 2006 from two tertiary care hospitals in Karachi, Pakistan, namely Aga Khan University Hospital (AKUH) and National Institute of Cardiovascular Diseases (NICVD).AKUH is one of the most advanced private tertiary care centers of Pakistan, and caters to a large number of people from all over the country. NICVD is a government-run, tertiary care hospital and as such, is approached by a population more indicative of the country's health status. Pakistan, as a developing country, is home to a vast majority of people living at or below poverty line. Low-cost services at this institute attract a greater number of patients. NICVD was thus chosen for sample selection to increase the reliability of our results and for better generalization of our data to the Pakistani population.The inclusion criteria were 1) patients of age 18 years and above, 2) those who had been diagnosed with ‘essential’ hypertension and 3) those who were on prescribed antihypertensive medications since at least the previous one month. Patients with co-existing medical conditions were also included. All people who fulfilled the inclusion criteria were then assessed for familiarity with Urdu, which is the national language of Pakistan and is understood and spoken by most people throughout the country, irrespective of ethnicity. Patients who could not converse in Urdu were excluded, due to the lack of appropriate translators.Patients who agreed to participate were explained the nature and the objectives of the study, and informed consent was formally obtained. The study was approved by the Ethical Review Committees of AKUH and NICVD. The information about patient's identity was not included with the other data and only the principal investigator had access to this information. No reference to the patient's identity was made at any stage during data analysis or in the paper.The data collection tool was a questionnaire, designed-based on an extensive literature review of similar studies Blood pressure was measured twice by the hospital health physicians and trained investigators using aneroid sphygmomanometers and stethoscopes. Blood pressure was measured in all subjects after they were in the resting state for 10 minutes and in sitting position in the right arm place at the level of the heart. An appropriate-sized cuff (cuff bladder encircling at least 80% of the arm) was used to ensure accuracy Patients were asked about details of their prescribed medication regimen. The information obtained was tabulated. All information was based on self-reporting and included number of prescribed antihypertensive drugs, trade names of all prescribed drugs along with the drug class, doses in milligrams (mg), frequency per day, duration of intake in months, time of intake of the drug , and any side effects associated with the drug. A standard drug manual was used to find out the generic class of the drug. Prescriptions, whenever they were available at the time of the interview, were used in getting reliable data, particularly from illiterate patients.The Aga Khan University Anxiety and Depression Scale (AKU-ADS) Adherence was defined as ‘the extent to which patients followed their medication schedules as prescribed by their health care providers’ To further increase the strength and consistency of our results, we included an adherence assessment through the Morisky Medication Adherence Scale (MMAS) vs. non-adherent status as the outcome variable, while various study variables were used as independent variables. Associations of study variables with the MMAS score were checked with the help of linear regression using MMAS score as the dependant variable and study variables as independent variables. A p-value of less than 0.05 was considered to be statistically significant for all analyses.All statistical analyses were performed using SPSS 13.0 for Windows. The questionnaire was pre-coded and all data was entered and checked twice by two different investigators. Based on a recent meta-analysis After pilot-testing and refining the questionnaire with 50 individuals, we interviewed 460 patients at both study centers. After exclusion of cases in which adherence could not be calculated, we included data on 438 cases. In this sample, 71% of the cases were recruited and interviewed at the NICVD, while 29% were recruited from AKUH. There were no statistically significant differences in the adherence and the study variables between the cases recruited from the two hospitals hence combined analysis of the data was done (data not shown). Due to significant difference in prevalence of hypertension in the various ethnic groups in Pakistan, we also recorded the ethnicity as provided by the patient. Ethnicity, however, was not associated with adherence or other study variables and therefore was not analyzed as a risk factor. According to the 80% cutoff level, 77% of the cases were adherent  and 23% were non-adherent .P<0.02), age remained only marginally different after division of cases into adherent and non-adherent groups. Subjects who were less than 40 years old were less adherent than those older than 70. The highest mean adherence rate was observed in the age group 70–80 years (mean adherence = 91±14%). Although mean adherence showed an overall increase with increasing monthly income and increasing level of education, no significant difference was observed. P<0.001). Although the presence of a single co-morbid condition slightly increased the adherence, the presence of two or more co-morbids led to a gradual decrease in adherence (P>0.05). The most frequently reported co-morbids were diabetes (23.1%) and ischemic heart disease (25.8%). Associations between co-morbidities and adherence, however, were not statistically significant.There were 199 males (mean age 54±10 years) and 239 females (mean age 50±11 years); 20% of the total cases were younger than 40 and 19% older than 60 years. Although we found adherence to increase with increasing age (P>0.05). A large proportion of our study sample had never been hospitalized (45%). The patients who had been hospitalized in the previous two years had significantly higher adherence (P<0.05). Surprisingly adherence increased with increasing number of anti-hypertensive drugs that a person was taking (P<0.05).A greater proportion of the cases suffering from hypertension-related complications were adherent (P<0.001) and lower systolic and diastolic blood pressures. A very small proportion of patients were aware of the risk factors for hypertension and an even smaller proportion knew about the complications. Greater awareness was associated with higher adherence.The overall level of awareness about hypertension and its treatment was very low. As shown in P<0.001) in the adherent group (2.7±1.2) compared to the non-adherent group (1.7±1). vs. 53 years), were illiterate or at a lower level of education (P<0.05), belonged to a lower income subgroup (P<0.05), and had higher systolic  and diastolic  pressures. A significantly greater proportion of patients with MMAS score ≤2 were depressed , according to AKU-ADS.The mean MMAS score in the overall sample was 2.5±1.3. MMAS score was significantly higher (P<0.02) and whether he/she was taking medication regularly or only for symptomatic relief (P<0.00001)Upon multivariate analysis, the only factors associated with adherence were the number of drugs that a patient was taking  Among the studies conducted on various populations of the world, using a similar cut-off, the adherence we observe is higher than what has been reported in a similar study in Malaysia (44.2%) Age was found to be significantly and independently associated with adherence in our study, with better adherence observed in older people. This finding is consistent with a number of other studies vs. 83.2%, respectively, P<0.001) An inverse relationship was observed between adherence and number of pills prescribed. Patients on monotherapy had a mean adherence of 79% compared to 90% for those on three drugs or more . This is in contrast to what has been frequently reported so far. A recent meta-analysis of eight studies reports that the average adherence for once-daily dosing was significantly higher than for multiple daily dosing (91.4% et al, showed a significant correlation between education and QOL among patients with hypertension in Gaza Strip and hypothesized that educational interventions would be essential in preventing high blood pressures and consequent mortality Baune et al. found forgetfulness, adverse effects and not liking to take medication among the reasons for poor adherence in a nationally representative sample in the United States Patients' beliefs and attitudes have been explored in studies worldwide to explain not taking medication as prescribed et al. Depression has recently been added to the list of factors associated with non-adherence to anti-hypertensive medication Our study design was limited in several aspects. Self-reporting was used as the only method of measuring adherence. Although this method has the disadvantages of recall bias, of eliciting only socially acceptable responses and hence, may overestimate adherence The adherence goal of 80% of prescribed dose is used conventionally in clinical trials of safety and efficacy The use of validated tools in our study further strengthens the reliability of our results. MMAS had a significant linear relation with adherence measured as a continuum. Most of the factors associated with non-adherence discussed above were associated with low MMAS scores of ≤2, including those which did not show an association with adherence at the cut-off of 80%, such as depression. More studies, however, are needed to demonstrate the validity of MMAS in the Pakistani population. Hence, we have reported only those factors as significantly affecting adherence that were common to both our criteria for measurement of adherence.In conclusion, we found younger age, monotherapy, poor awareness and symptomatic treatment to be the strongest factors affecting adherence to anti-hypertensive medication amongst Pakistani patients. Future studies are recommended to confirm our findings, as adherence to medication predicts better outcomes and indicators of poor adherence to a medication regimen are a useful resource for physicians to help identify patients who are most in need of interventions to improve adherence.We recommend the implementation of education campaigns to increase awareness about the risk factors, natural history, complications and treatment of hypertension. Global events, such as World Hypertension Day, could be used as a forum to highlight these issues. Patient support groups can be employed to help the non-adherent. Patients who have suffered complications due to non-adherence could be requested to voluntarily share their experiences. Print and audiovisual media would be very helpful in dissemination of information. Most importantly, though, physicians have to pay special attention to patient education and counseling when treating hypertensive patients.


Many studies have demonstrated that health related quality of life (HRQoL) improves, on average, after coronary artery bypass graft surgery (CABGS). However, this average improvement may not be realized for all patients, and it is possible that there are two or more distinctive groups with different, possibly non-linear, trajectories of change over time. Furthermore, little is known about the predictors that are associated with these possible HRQoL trajectories after CABGS.182 patients listed for elective CABGS at The Royal Melbourne Hospital completed a postal battery of questionnaires which included the Short-Form-36 (SF-36), Profile of Mood States (POMS) and the Everyday Functioning Questionnaire (EFQ). These data were collected on average a month before surgery, and at two months and six months after surgery. Socio-demographic and medical characteristics prior to surgery, as well as surgical and post-surgical complications and symptoms were also assessed. Growth curve and growth mixture modelling were used to identify trajectories of HRQoL.improvers and non-improvers). A series of logistic regression analyses identified different predictors of group membership for PCS and MCS trajectories. For the PCS the most significant predictors of non-improver membership were lower scores on POMS vigor-activity and higher New York Heart Association dyspnoea class; for the MCS the most significant predictors of non-improver membership were higher scores on POMS depression-dejection and manual occupation.For both the physical component summary scale (PCS) and the mental component summary scale (MCS) of the SF-36, two groups of patients with distinct trajectories of HRQoL following surgery could be identified (It is incorrect to assume that HRQoL will improve in a linear fashion for all patients following CABGS. Nor was there support for a single response trajectory. It is important to identify characteristics of each patient, and those post-operative symptoms that could be possible targets for intervention to improve HRQoL outcomes. Coronary artery bypass graft surgery (CABGS) is aimed at alleviating patients' morbidity and prolonging their lives. Given the high success rate of such surgery in achieving these aims, it is clear why the assessment of health related quality of life (HRQoL) is of such importance. Longitudinal studies -3 have cMost studies that have investigated change over time in CABGS patients ,3,8-10 hWilson and Cleary  provide The biological/physiological or medical characteristics that have been consistently associated with poorer HRQoL outcomes after CABGS include pre-surgical cardiac functional status, such as the New York Heart Association (NYHA) classification of dyspnoea ,15,16, cIt is not surprising that symptoms of depression or anxiety have been associated with a marked alteration in mental HRQoL and worse outcomes after CABGS. Among patients scheduled for CABGS, the prevalence of depressive symptoms is high, with a recent Australian study finding that over half of bypass candidates were diagnosed as depressed . PreoperDecreased cognitive function has been recognized to be a major, although probably partly reversible, unintended outcome of CABGS . A growiAmong the individual characteristics that have been associated with poorer HRQoL outcomes after coronary interventions are age and gender. Younger patients ,25 have One possible environmental influence on HRQoL outcomes is cardiac rehabilitation (CR) program attendance. Despite its efforts to improve the psychological, as well as the physical, well-being of patients , CR atteThe aims of the present study were:a. to identify the general form of change of HRQoL over time, i.e. linear or non-linear, using growth curve modelling (GCM)b. to identify the different trajectories of HRQoL over a six month period for both physical health and mental health, using growth mixture modelling (GMM)c. to identify the socio-demographic, medical, psychological or cognitive variables that predict group membership of HRQoL trajectories.Eligible patients were adults on the waiting list for CABGS at The Royal Melbourne Hospital, Australia, between July 2001 and April 2004. Patients were excluded from the study if they were under the age of 18 or over 85 years of age; were subsequently assigned to a non-CABGS procedure; or refused consent. Patients could withdraw from the study at any stage between consent to participate and the final follow-up assessment at six months. The following were criteria for withdrawal: failure to return postal questionnaires, death, physical illness or frailty preventing participation, occurrence of a major medical or neurological illness that would independently affect cognitive outcome, refusal, and unavailability for follow-up for other reasons.2 = 10.6, df = 1, p =.001) or a positive family history of cardiovascular disease . There were no significant differences in all other medical variables, gender and age. Of the 183 returned questionnaires, HRQoL data were available for 182 patients.Of a consecutive sample of 444 patients to whom a questionnaire package was posted, 220 (49%) returned the questionnaires. The mean interval between completion of the baseline questionnaire and surgery was 33 days . Of the returned questionnaires, 37 were excluded because, based on medical records, it was ascertained that the patient had not undergone CABGS. In order to ascertain reasons for non-completion or non-return of questionnaires, a random sample of one in three patients (n = 78) was contacted by telephone. Amongst these patients, reasons for non-completion of the questionnaire were language difficulties (42%), refusal (38%), death (12%) or disability (8%). The 261 patients who were either excluded or did not return questionnaires were compared with the 183 included patients on all medical variables, gender and age. Excluded patients were less likely to have either high cholesterol (χn = 117) were compared with those of the patients who did not complete it at any of these time points (n = 65). There were no significant differences between dropouts and completers on any pre-operative medical or socio-demographic characteristics.To determine whether there was any systematic bias to the analyses due to participant dropout over the six months, the socio-demographic and pre-operative medical characteristics of patients who completed the HRQoL measure at all three time points . Very high PCS scores indicate no physical limitations, disabilities or decrements in well-being as well as a high energy level. Very low PCS scores indicate substantial limitations in self-care, physical, social and role activities; severe bodily pain; or frequent tiredness. Very high MCS scores indicate frequent positive affect, absence of both psychological distress and limitations in usual social/role activities due to emotional problems, while very low MCS scores indicate frequent psychological distress and substantial social and role disability due to emotional problems. A comprehensive literature review [The (Short-Form) SF-36 . The PCSe review  of the pe review .Patient mood was assessed by the Profile of Mood States (POMS) . The POMA modified 28-item version of the Everyday Functioning Questionnaire (EFQ)  was usedA range of pre-surgical, surgical and post-surgical variables was obtained from hospital medical records. Many of these variables were identified in the published literature as risk variables for mortality and health outcomes after CABGS ,8-10,44.For each SF-36 summary scale, modelling was carried out in two stages. At Stage 1 GCM was undertaken. With GCM, individuals are assumed to come from one population and a mean growth curve can be estimated using all individuals. The latent variables representing the intercept (i.e. estimated baseline scores) and trajectory (i.e. estimated change over time) for each sub-scale were derived from the sub-scale scores obtained at the three time points.2 value and Comparative Fit Index (CFI) [2 values and higher CFI scores are indicative of a better fit of the model to the data. More specifically, CFI values greater than .900 indicate a good model fit [Three separate trajectory shapes were tested: linear, square root and quadratic. While a linear function assumes constant change, a square root function assumes more rapid change in the early months, and a quadratic function assumes more rapid change in the later months. These functions were selected from a larger number of possible functions because they represented the most likely trajectory shapes. Selection of the best trajectory shape for each summary scale was based on two commonly used measures of model fit: χex (CFI) . Lower χodel fit .In order to examine the extent to which the intercept and slope were related to the medical socio-demographic and emotional variables the two model parameters were regressed on the 16 potential predictors. A significant coefficient for the term "Intercept regressed on predictor" indicates that the baseline  HRQoL varies according to the level of the predictor. A significant coefficient for the term "Slope regressed on predictor" indicates that the change over time in HRQoL varies according to the levels of the predictor.The second stage of analysis involved GMM. Unlike GCM, GMM calculates fit statistics for sub-groups of individuals called "mixtures", each described by a different growth curve. Hence, GMM utilises more fully the heterogeneity that results from variation in sub-scale scores over time . Lower BIn order to determine the predictors of PCS and MCS sub-groups, a screening process and a series of logistic regression analyses were undertaken. The screening process aimed to optimize the number of potential predictors to be included in the multivariate analysis in order to reach a satisfactory compromise between making Type I and Type II errors. Two screening strategies were adopted. First, dichotomous variables were excluded from further consideration if there were fewer than 10 cases endorsed in any of the two response categories. Second, Chi-square and one-way analysis of variance were used to explore differences between identified sub-groups for variables measured using nominal and interval scales, respectively. Removing those variables that had p > .10 resulted in a reduction of pool predictors from 48 to 12 for PCS and from 48 to 17 for MCS, thereby reducing the probability for type I errors. Using a p-value of > .10 rather than >.05 reduced the likelihood of type II errors.The remaining independent variables associated with the outcome variables with a p-value of = .10 were then included in a series of logistic regression analyses. For each SF-36 summary scale logistic regression analyses were run separately for socio-demographic variables, medical variables, psychosocial scores and cognitive symptoms. The significant predictors from these analyses were included in two final logistic regression analyses; one for PCS and one for MCS. A backwards regression approach (p < .05 to remain in model) was used for all logistic regression analyses.Descriptive statistics including mean, standard deviations, frequencies and percentages were used to summarize and present the data. These analyses were performed using SPSS version 13.0 .Pre-operative characteristics of the study population are detailed in Table Table 2 values and CFIs well above the acceptable level of .900, indicating very good model fit. For both sub-scales the intercept and slope parameters were highly significant.For the PCS, a linear trajectory was found to provide the best fit of the data. Combined with a positive slope parameter, this suggests that PCS scores improved at a steady rate (1.37 units per month) over the six months. For the MCS, a square root function provided the best model fit. Again, combined with the positive slope parameter this indicates that MCS scores improved more rapidly in the first two months followed by relatively less improvement between two and six months. As shown in Table Table For the PCS, lower baseline HRQoL was associated with poorer NYHA functional class; peripheral vascular disease; higher POMS tension-anxiety, depression-dejection, fatigue-inertia, confusion-bewilderment; and lower vigor-activity. No variables were significantly associated with change in physical HRQoL over time.For the MCS, lower baseline HRQoL was associated with previous cardiac surgery; higher POMS tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusion-bewilderment; and lower vigor-activity. Greater improvement in mental HRQoL over time was associated with having a partner and higher scores on POMS tension-anxiety, depression-dejection, anger-hostility, and fatigue-inertia.Table Figure The predicted and actual group trajectories for the two-group model for the MCS are presented in figure non-improver group was the presence of atrial fibrillation (p < .10), having chronic heart failure (p < .05), higher BMI (p < .10), having a previous MI (p < .05), higher NYHA functional status (p < .001), having cardiac arrhythmia after surgery (p < .05), and higher pulmonary pressure recorded during surgery (p < .05). For the socio-demographic variables non-improver status was associated with being female (p < .10), being born outside of Australia (p < .05), and not being in the workforce (p < .05). For the psychosocial variable only lower scores on POMS vigor-activity (p < .001) and higher scores on POMS fatigue-inertia (p < .05) were associated with non-improver status. No cognitive variables distinguished improvers from non-improvers for the PCS.The screening process found that three categories of variables were significant bivariate predictors of PCS group status. For the medical variables, a greater likelihood of being in the non-improver membership. Of the three socio-demographic variables, being not in the workforce was a significant unique predictor of non-improvement. From the psychosocial variables, both POMS (lower) vigor-activity and (higher) fatigue-inertia, remained significant predictors in the third multivariate analysis.When the seven medical variables were included in a logistic regression to predict PCS group, three  were significant unique predictors of non-improvers) were: non-participation in the workforce, lower POMS vigor-activity scores, higher NYHA dyspnoea class, experiencing a new cardiac arrhythmia during or following the operation, and higher pulmonary pressure recorded during the procedureTable non-improver group was the presence of atrial fibrillation (p < .10), having off-pump surgery (p < .10), having had previous cardiac surgery (p < .001), having a previous MI (p < .10), and non-attendance at CR (p < .05). For the socio-demographic variables non-improver status was predicted by not having a current partner (p < .10) and having a manual occupation (p < .05). For the psychosocial variables non-improver status was associated with POMS tension-anxiety anger-hostility, vigor-activity, fatigue-inertia, confusion-bewilderment and depression-dejection . For the cognitive variables non-improver status was associated with higher EFQ memory (p < .05), organisation (p < .001), communication (p < .05), and concentration (p < .001).The screening process found that there were significant bivariate predictors of MCS group status from all four categories of variables. For the medical variables, a greater likelihood of being in the The four separate logistic regressions identified the following variables as significant unique predictors of non-improvement: previous cardiac surgery, previous MI, lower CR attendance, manual occupation, higher (poorer) scores on POMS depression-dejection, and higher (poorer) scores on EFQ concentration.non-improvers) included: previous cardiac surgery, manual occupation, higher scores on POMS depression-dejection and higher scores on EFQ concentration.Table The present study supports previous findings -3,7,50 tFor the total sample there were significant medical and psychosocial predictors of baseline physical HRQoL including poorer NYHA functional class, having peripheral vascular disease and poorer emotional state. Baseline mental HRQoL was predicted by only previous cardiac surgery among the medical variables and poorer scores on all emotional scales. No cognitive variables significantly predicted baseline HRQoL. For the total sample there were no significant predictors of change in physical HRQoL over time. The apparent contradictory findings that poorer emotional scores predicted greater improvement over time in mental HRQoL may be explained by the fact that these patients had much lower scores at baseline and had greater capacity to change over time. It does appear that having a partner was beneficial for recovery in mental HRQoL and this finding is consistent with previous studies ,51.It is important to note that these results only relate to the trajectory of the whole sample. These overall trends, may mask the true picture of recovery following CABGS. The findings of the present study support the hypothesis that identifiable sub-groups of patients exists, each described by a different growth curve, and that these different groups may have different outcomes. Indeed, in this sample, there are two distinct groups of patients for both the physical and mental components of HRQoL. The GMM has identified a larger proportion of the patient population who experience rapid and continued improvement in PCS and MCS scores over time. Of serious clinical relevance, however, the analysis has also identified a smaller group of patients who experience little or no improvement during the first six months following surgery.non-improver membership for the MCS. Characteristics of the individual, namely not being in the workforce and having a manual occupation, were predictive of non-improver membership for the PCS and the MCS respectively. These findings are consistent with those of past studies [The findings of this study lend support to investigation of a range of biopsychosocial predictors, such as that advocated by Wilson and Cleary , in expl studies ,52. It i studies . These f studies , may expnon-improver membership for the PCS is also supported by previous studies [Symptom status was also highly predictive of trajectory classification. The finding that higher NYHA dyspnoea class was predictive of  studies . Presuma studies  resultinnon-improver membership of the PCS, and that higher scores on the POMS depresssion-dejection scale predicted non-improver membership for the MCS. These findings are consistent with two recent studies that have also found higher pre-operative depression scores to predict lower HRQoL six months after surgery [It is also not surprising that lower scores on the POMS vigor-activity scale indicated  surgery ,56. It i surgery , are les surgery , and mor surgery , all facnon-improver membership for the MCS. This finding is supported by a previous study which showed that perceived cognitive function, reflecting ability to concentrate, was a major determinant of HRQoL outcomes in a cross-sectional study of Swedish CABGS patients [This study adds weight to the growing body of evidence that patients' perceived cognitive abilities may influence HRQoL outcomes. Lower scores on EFQ concentration were predictive of patients . It has patients . Furtherpatients  which reimprover group when medical variables were analysed separately, but was not significant in the presence of competing variables. This finding is consistent with other studies that have found little or no difference between CR attenders and non-attenders in HRQoL measured by the SF-36 [The present study also improved upon previous studies by assessing the impact of operational and post-surgical variables. It has been argued that HRQoL in the months after CABGS may be affected by environmental factors such as processes and structures of care, complications of the surgery, or interim life change or health events ,14. The he SF-36 ,32. It hhe SF-36 . CR was he SF-36 .The main limitations of the present study concern the fact that it relied on postal collection of data with over half of the questionnaires not being returned. This limitation raises the possibility that the results may not be generalisable to all CABGS patients. Those who did not return the questionnaire had lower rates of high cholesterol and were less likely to have a positive family history of heart disease. However, in all other medical variables there were no significant differences between questionnaire returners and non-returners. Moreover, there were no differences with regard to gender and age. Other socio-demographic measures such as education level and employment status, were not investigated in excluded patients, so the possibility that non participants differed in these characteristics has not been examined.The present study relied upon self-report for psychosocial measures and HRQoL rather than formal diagnostic criteria. Although the questionnaire order was varied, the possibility of a self-report bias exists. It has been shown that patients with depressive symptoms may over-report negative aspects of HRQoL and a spurious exposure-outcome association may be generated . The incAnother possible limitation of the study is the reported lack of responsiveness of the SF-36. Hawkes and colleagues argue that the SF-36 may not be sufficiently responsive as an outcome measure with CR patients . Devon  comparedThe findings of the present study highlight the probability that sub-groups of patients exist within the CABGS population, each with its own trajectory of HRQoL following surgery, which may not necessarily be linear. The results further imply that particular socio-demographic, medical and symptom-related variables are useful in predicting membership of these sub-groups. When considering these predictors of HRQoL outcomes, it is important to consider a comprehensive model that incorporates pre-operative, operative and post-operative variables, psychosocial and cognitive symptoms, and characteristics of the individual and the environment. Furthermore, development of interventions to improve HRQoL outcomes and enhanced clinical decision making may result from improved identification of predictors of HRQoL after CABGS.CABGS Coronary artery bypass graft surgeryHRQoL Health related quality of lifeNYHA New York Heart AssociationGCM Growth curve modellingGMM Growth mixture modellingSF-36 The (Short-Form) SF-36PCS Physical component summaryMCS Mental component summaryPOMS Profile of Mood StatesEFQ Functioning QuestionnaireBMI Body mass indexCR Cardiac rehabilitationCFI Comparative Fit IndexBIC Bayesian Information CriterionMI Myocardial infarctionThe author(s) declare that they have no competing interests.MLG drafted the manuscript and analysed the data using SPSS. PE supervised the data analysis, assisted with the interpretation of findings, and analysed the data using M-Plus. MW, BM and AJG participated in the design of the study. CE and RH participated in the coordination of the study. All authors read and approved the final manuscript.


Clinical trials show that asthma can be controlled in the majority of patients, but poorly controlled asthma still imposes a considerable burden. The level of asthma control achieved reflects the behaviour of both healthcare professionals and patients. A key challenge for healthcare professionals is to help patients to engage in self-management behaviours with optimal adherence to appropriate treatment. These issues are particularly relevant in primary care, where most asthma is managed. An international panel of experts invited by the International Primary Care Respiratory Group considered the evidence and discussed the implications for primary care practice.Causes of poor controlClinical factors such as exposure to triggers and concomitant rhinitis are important but so are patient behavioural factors. Behaviours such as smoking and nonadherence may reduce the efficacy of treatment and patients' perceptions influence these behaviours. Perceptual barriers to adherence include doubting the need for treatment when symptoms are absent and concerns about potential adverse effects. Under-treatment may also be related to patients' underestimation of the significance of symptoms, and lack of awareness of achievable control.ImplicationsThree key implications for healthcare professionals emerged from the debate. First, the need for simple tools to assess asthma control. Two approaches considered were the monitoring of biometric markers of control and questionnaires to record patient-reported outcomes. Second, to understand the reasons for poor control for individual patients, identifying both clinical (e.g. rhinitis) and behavioural factors (e.g. smoking and nonadherence to treatment). Third was the need to incorporate, within asthma review, an assessment of patient perspectives including their goals and aspirations and to elicit their beliefs and concerns about asthma and its treatment. This can be used as a basis for agreement between the healthcare professional and patient on a predefined target regarding asthma control and a treatment plan to achieve this.Optimum review of asthma is essential to improve control. A key priority is the development of simple and effective tools for identifying poor control for individual patients coupled with a tailored approach to treatment to enable patients to set and achieve realistic goals for asthma control. Asthma is a chronic inflammatory disease of the airways, resulting in widespread but variable airflow obstruction in response to a variety of stimuli. AirflowNational and international guidelines clearly state that the aim of asthma management is to achieve and maintain control,2. ContrWith the medical treatments currently available, it is possible to achieve control in the majority of patients with asthma, at least in the artificial setting of a clinical trial. HoweverThere is evidence, from a 10 year Finish study, that enhancing the delivery of healthcare services, can improve asthma control but, in There are many possible reasons for poor control Table . HoweverThese issues are of particular relevance in primary care, where the majority of patients with asthma are managed. An international panel of general practitioners, respiratory physicians, patient representatives and others with an interest in asthma control, under the auspices of the International Primary Care Respiratory Group (IPCRG), considered the evidence about patient perspectives and discussed the resulting implications. This report summarises the discussion.Presentations by group members on different aspects of asthma control resulted in a wide ranging discussion that crystallised around three key questions.1. What levels of asthma control are patients currently achieving?2. What are the common causes of poor control?3. What are the main patient-related determinants of asthma control?Each of these questions is addressed, below.Large population-based studies, varying in methodology and funding, suggest that a substantial proportion of patients with asthma currently experience suboptimal levels of asthma control. The AIRE  study, involving over 2,800 people with asthma in France, Germany, Italy, Netherlands, Spain, Sweden and UK, found that asthma symptoms are part of everyday life for many patients. More thFindings consistent with the AIRE study have been reported from the INSPIRE  study. This stThere are many reasons why asthma may be poorly controlled, both clinical and behavioural. Important clinical factors include the genetic characteristics of the individual, type of asthma , co-morbidity ,14. The The behaviour of clinicians is vital in making an accurate diagnosis and prescribing the best treatment but also in carrying out appropriate review of progress and subsequent control. HealthcPatient behaviours are also key as the level of asthma control is influenced by adherence to treatment and other self-management behaviours and smokPatients may unnecessarily accept symptoms, assuming that frequent symptoms, exacerbations and lifestyle limitations are an inevitable consequence of having asthma. In the When asked about the things that they most dislike about asthma, patients most report symptoms such as cough, breathlessness, and lifestyle restrictions. In a stA discrete choice experiment showed that patients were willing to experience higher levels of wheeze and sleep disturbance to avoid cough and breathlessness . HoweverCurrently, asthma control is measured in ways defined by healthcare professionals . However, these standard methods use surrogate markers that do not seem to be necessarily relevant to the individual patient. In contrast, psychological treatments routinely use patient-defined goals, achievement of which can be seen by both patient and healthcare professional as markers of improvement. For example, an agoraphobic patient may set a goal of walking to the shop to buy a newspaper each day. Identifying and using patient goals has been shown to encourage patient involvement, which may lead to better adherence with therapy. It is aFew published studies have explored this issue in asthma with the exception of two recent studies. In the first study in 329 aIn the second study of 83 patients with exercise-induced asthma treated using montelukast or placebo, patients were also able to set their own goals. The natPatients may not take the medications they have been prescribed, contributing to poor disease control. Regardless of age, gender and socioeconomic status of patients, and type and severity of disease, non-adherence rates of over 30% have consistently been noted across chronic illnesses and withNonadherence is best thought of as a variable behaviour, rather than a trait characteristic: most people are nonadherent some of the time. Nonadherence can have both intentional and unintentional causes. Unintentional nonadherence arises from capacity and resource limitations that prevent patients from implementing their decisions to follow treatment recommendations and involves individual constraints  and aspects of their environment . Intentional nonadherence arises from the beliefs, attitudes and expectations that influence patients' motivation to begin and persist with the treatment regimen.need for medication relative to their concerns about potential negative effects of taking it. The utility of this simple necessity-concerns framework in explaining nonadherence has been shown in studies across a range of chronic illnesses  may  may 65] There are a number of asthma-specific patient-based measures available that vary in characteristics, technical validity and ease of use. The Rule of Two™ consists of three items covering asthma symptoms and rescue medication use, each of which is answered with 'yes' (= 2 points) or 'no' (= 1 point) so that summing the answers gives a score ranging from 3 (= poor control) to 6 (= good control). AlthougIdentifying poor asthma control is the first step in improving it. The next step is to establish the reasons for poor control in individual patients. This should include an assessment of whether patient behaviours such as smoking or treatment nonadherence might be contributory factors. Patients may be reluctant to admit smoking or nonadherence if they believe that this will offend the clinician. However, asking adherence questions in a supportive manner, which sanctions nonadherence, can overcome this problem leading to more accurate reports.It is also important to identify the specific reasons for nonadherence in individual patients. One of the reasons why previous interventions to improve adherence have met with limited success is that Healthcare professionals can provide information about illness and treatment. However, unless the information given has an impact on patients' common-sense beliefs about the illness and treatment, it will not change patient behaviour. Healthcare professionals should ask about current illness and treatment beliefs. Although patient beliefs govern attitudes towards therapy, these beliefs are not fixed and can be changed through education and negotiation, leading to a better understanding of asthma that may promote more effective self-care behaviours. In shor1) provide a common-sense rationale for the necessity of treatment that is consistent with the patient's common-sense model of asthma and their goals for asthma control2) elicit and address specific concerns about treatment3) prescribe a convenient treatment regimen tailored to address practical barriers to adherence ).Identifying and addressing misplaced health beliefs (e.g. asthma is an episodic disease) may be helped by tailoring education to the patient's own needs and goals. Explicitly eliciting patient goals and using these as a basis for treatment and education may allow professionals to identify more effectively what is important to the patient and allow the patient to assess meaningful changes in their asthma. The importance of the patient in their own self-care is increasingly recognised, with development of initiatives to support self-care. TeachinThe identification of non-adherence as a cause of poor control, and the factors contributing to poor adherence, has increased recognition of the need for individual patient-centred reviews. However, there are increasing resource constraints in primary care. Currently, asthma reviews are often not standardised in structure and data collection, are not comprehensive, fail to address the needs and expectations of patients, are ineffective at reducing morbidity and mortality, and are poorly attended.The Minimal Asthma Assessment Tool (MAAT) is under development as a method to address some of these issues, and to help prioritise patients for primary care review by identifying poor asthma control and the causes of poor control for individual patients. The MAAIt is possible to improve current levels of asthma control if healthcare professionals do four things:1) use appropriate, patient-centred tools to assess control2) identify the reasons for poor control in individual patients3) work with patients to design individual treatment plans that address poor control and the causes of poor control, taking account of patient goals and aspirations4) monitor outcomes and take appropriate action through regular reviewMost of the authors or their research teams have received honoraria at various times for their involvement in advisory panels or meetings, and/or funding for research projects from a number of companies marketing respiratory products. However, the authors declare that they have no competing interests that have affected their views expressed in this paper.All authors were present for the full duration of the discussion and contributed by making presentations and/or participating in the ensuing discussion. All authors have had the opportunity to read and amend draft versions of the manuscript.The pre-publication history for this paper can be accessed here: