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Microalbuminuria is the earliest sign of diabetic nephropathy, and is a marker of increased diabetic cardiovascular morbidity and mortality. We investigated the prevalence of albuminuria and associated risk factors among Type 2 diabetes (T2DM) patients, who were attending diabetes clinics at primary healthcare facilities in Bahrain. This was a cross-sectional study on 712 adult T2DM Bahraini patients screened for albuminuria using albumin:creatinine ratio test (ACR), in 9 selected primary healthcare centers in Bahrain in the period February-March 2006. Of the 702 participants, 196 (27.9%) were albuminuric. The prevalence of microalbuminuria (ACR>3.4 mg albumin/mmol creatinine) and macroalbuminuria (protein:creatinine ratio >22 mg protein/ mmol creatinine) were 22.0% (no.=155) and 5.8% (no.=41), respectively. Univariate analysis demonstrated significant associations between albuminuria and older age (>65 yr), longer duration of diabetes, high glycated hemoglobin (HbA1c), elevated triglycerides, total- and LDL-cholesterol, systolic (>160 mmHg) and diastolic (>90 mmHg) blood pressure (BP), and retinopathy. Multivariate regression analysis showed that high HbA1c, higher systolic BP, and long duration of diabetes, were significant predictors of albuminuria, while older age, male gender, and higher triglycerides were borderline predictors. Albuminuria in Bahraini T2DM patients was related to poor glycemic control, higher systolic BP, and longer duration of diabetes. Effective preventive and control strategies of those factors should be urgently implemented.

Aims: To determine the effects of the Diabetes Manual on glycaemic control, diabetes-related distress and confidence to self-care of patients with Type 2 diabetes., Methods: A cluster randomized, controlled trial of an intervention group vs. a 6-month delayed-intervention control group with a nested qualitative study. Participants were 48 urban general practices in the West Midlands, UK, with high population deprivation levels and 245 adults with Type 2 diabetes with a mean age of 62 years recruited pre-randomization. The Diabetes Manual is 1:1 structured education designed for delivery by practice nurses. Measured outcomes were HbA(1c), cardiovascular risk factors, diabetes-related distress measured by the Problem Areas in Diabetes Scale and confidence to self-care measured by the Diabetes Management Self-Efficacy Scale. Outcomes were assessed at baseline and 26 weeks., Results: There was no significant difference in HbA(1c) between the intervention group and the control group [difference -0.08%, 95% confidence interval (CI) -0.28, 0.11]. Diabetes-related distress scores were lower in the intervention group compared with the control group (difference -4.5, 95% CI -8.1, -1.0). Confidence to self-care Scores were 11.2 points higher (95% CI 4.4, 18.0) in the intervention group compared with the control group. The patient response rate was 18.5%., Conclusions: In this population, the Diabetes Manual achieved a small improvement in patient diabetes-related distress and confidence to self-care over 26 weeks, without a change in glycaemic control. Further study is needed to optimize the intervention and characterize those for whom it is more clinically and psychologically effective to support its use in primary care.

Objective: In the management of type 2 diabetes, a complex interaction takes place between medical professionals' treatment goals and patients' health beliefs about the disease and its treatment options. The contribution of self-management education to adherence in general or even more specifically to medicine taking is not known. We assessed educational interventions aimed at improving adherence to medical treatment recommendations, other than lifestyle advice., Study Design: Systematic literature review., Setting: This paper represents an analysis of eight articles describing an educational intervention as a subgroup of a Cochrane Review [E. Vermeire, J. Wens, P. Van Royen, Y. Biot, H. Hearnshaw, A. Lindenmeyer, Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus, Cochrane Database of Systematic Reviews 2005, Issue 2, Art. No.: CD003638, doi:10.1002/14651858.CD003638.pub2] on interventions to improve adherence to treatment recommendations in people with type 2 diabetes., Results: Four studies reported interventions using face-to-face education, two reported on the effects of group education and two on distance education by telemedicine. Due to poor quality of study designs, a variety of heterogeneous outcome measures in different time intervals, unclear definitions of adherence, and difficulties in evaluating different aspects of education performed, general conclusions could not be drawn., Conclusion: Consistent conclusions about the effectiveness of educational interventions on adherence to treatment recommendations were hard to be drawn. There is an urgent need for well-designed intervention studies on the effect of different aspects of education on adherence to treatment recommendations.

Objective: To assess the benefits of involving health-care users in diabetes research., Design and Participants: For this qualitative case study, semi-structured interviews were conducted with researchers who had worked extensively with the group. During regular meetings of the Research User Group, members discussed their views of the group's effectiveness as part of the meeting's agenda. Interviews and discussions were transcribed, coded using N-Vivo software and analysed using constant comparative methods., Results: Involvement of users in research was generally seen as contributing to effective and meaningful research. However, the group should not be considered to be representative of the patient population or participants of future trials. An important contributor to the group's success was its longstanding nature, enabling users to gain more insight into research and form constructive working relationships with researchers. The user-led nature of the group asserted itself, especially, in the language used during group meetings. A partial shift of power from researchers to users was generally acknowledged. Users' main contribution was their practical expertise in living with diabetes, but their involvement also helped researchers to remain connected to the 'real world' in which research would be applied. While the group's work fulfilled established principles of consumer involvement in research, important contributions relying on personal interaction between users and researchers were hard to evaluate by process measures alone., Conclusions: We demonstrated the feasibility, acceptability and effectiveness of this longstanding, experienced, lay-led research advisory group. Its impact on research stems from the continuing interaction between researchers and users, and the general ethos of learning from each other in an on-going process. Both process measures and qualitative interviews with stakeholders are needed to evaluate the contributions of service users to health research.

Background: The development of the Internet has created new opportunities for health care provision, including its use as a tool to aid the self-management of chronic conditions. We studied stakeholder reactions to an Internet-based "virtual clinic," which would allow people with diabetes to communicate with their health care providers, find information about their condition, and share information and support with other users., Objective: The aim of the study was to present the results of a detailed consultation with a variety of stakeholder groups in order to identify what they regard as the desirable, important, and feasible characteristics of an Internet-based intervention to aid diabetes self-management., Methods: Three focus groups were conducted with 12 people with type 1 diabetes who used insulin pumps. Participants were recruited through a local diabetes clinic. One-on-one interviews were conducted with 5 health care professionals from the same clinic (2 doctors, 2 nurses, 1 dietitian) and with 1 representative of an insulin pump company. We gathered patient consensus via email on the important and useful features of Internet-based systems used for other chronic conditions (asthma, epilepsy, myalgic encephalopathy, mental health problems). A workshop to gather expert consensus on the use of information technology to improve the care of young people with diabetes was organized., Results: Stakeholder groups identified the following important characteristics of an Internet-based virtual clinic: being grounded on personal needs rather than only providing general information; having the facility to communicate with, and learn from, peers; providing information on the latest developments and news in diabetes; being quick and easy to use. This paper discusses these characteristics in light of a review of the relevant literature. The development of a virtual clinic for diabetes that embodies these principles, and that is based on self-efficacy theory, is described., Conclusions: Involvement of stakeholders is vital early in the development of a complex intervention. Stakeholders have clear and relevant views on what a virtual clinic system should provide, and these views can be captured and synthesized with relative ease. This work has led to the design of a system that is able to meet user needs and is currently being evaluated in a pilot study.

Aims: To develop and validate an easy-to-use questionnaire to identify obstacles to self management in Type 2 diabetes., Methods: The Diabetes Obstacles Questionnaire (DOQ) was developed from earlier research and the literature. It was completed by 180 people with Type 2 diabetes, recruited from 22 general practices in the UK. Responders also completed a quality-of-life questionnaire (ADDQoL) and the Problem Areas in Diabetes (PAID) scale., Results: From analysis of the 176 usable questionnaires, 36 items of the original 113 items were deemed redundant. The remaining 77 items were assembled into eight sub-scales covering Medication, Self Monitoring, Knowledge and Beliefs, Diagnosis, Relationships with Health-Care Professionals, Lifestyle Changes, Coping, and Advice and Support. Each sub-scale had a factor structure of no more than three factors, had Cronbach's alpha of more than 0.75, and a Kaiser-Meyer-Olkin of more than 0.75. Each sub-scale correlated significantly with the PAID scale (P < 0.01), demonstrating criterion validity. Construct validity was shown by significant correlation between HbA(1c) and the sub-scales which relate to managing blood glucose levels: Self Monitoring, Relationship with Health-Care Professionals, Lifestyle Changes and Coping. Construct validity was further shown by significant correlation between QoL scores and Medication, Lifestyle Changes and Coping., Discussion: The DOQ, comprising eight sub-scales, is a usable, valid instrument for both clinical and research settings. It helps to identify in detail the obstacles which an individual finds in living with Type 2 diabetes.

Background: There is increasing interest in developing peer-led and 'expert patient'-type interventions, particularly to meet the support and informational needs of those with long term conditions, leading to improved clinical outcomes, and pressure relief on mainstream health services. There is also increasing interest in telephone support, due to its greater accessibility and potential availability than face to face provided support. The evidence base for peer telephone interventions is relatively weak, although such services are widely available as support lines provided by user groups and other charitable services., Methods/design: In a 3-arm RCT, participants are allocated to either an intervention group with Telecare service provided by a Diabetes Specialist Nurse (DSN), an intervention group with service provided by a peer supporter (also living with diabetes), or a control group receiving routine care only. All supporters underwent a 2-day training in motivational interviewing, empowerment and active listening skills to provide telephone support over a period of up to 6 months to adults with poorly controlled type 2 diabetes who had been recommended a change in diabetes management (i.e. medication and/or lifestyle changes) by their general practitioner (GP). The primary outcome is self-efficacy; secondary outcomes include HbA1c, total and HDL cholesterol, blood pressure, body mass index, and adherence to treatment. 375 participants (125 in each arm) were sought from GP practices across West Midlands, to detect a difference in self-efficacy scores with an effect size of 0.35, 80% power, and 5% significance level. Adults living with type 2 diabetes, with an HbA1c > 8% and not taking insulin were initially eligible. A protocol change 10 months into the recruitment resulted in a change of eligibility by reducing HbA1c to > 7.4%. Several qualitative studies are being conducted alongside the main RCT to describe patient, telecare supporter and practice nurse experience of the trial. DISCUSSION AND IMPLICATIONS OF THE RESEARCH: With its focus on self-management and telephone peer support, the intervention being trialled has the potential to support improved self-efficacy and patient experience, improved clinical outcomes and a reduction in diabetes-related complications., Trial Registration: Current Controlled Trials, ISRCTN63151946.

Quantitative studies failed to determine variables which consistently explain adherence or non-adherence to treatment recommendations. Qualitative studies identified issues such as the quality of the health provider-health receiver relationship and the patient's health beliefs. According to these findings, 39 focus groups of 246 people living with type-2 diabetes were conducted in seven European countries, assessing health beliefs, communication with caregivers and problems encountered in adhering to treatment regimens. Meta-ethnography was later applied to make a qualitative meta-analysis. Obstacles to adherence are common across countries, and seem to be related less to issues of the health-care system and more to patient's knowledge about diabetes, beliefs and attitudes and the relationship with health-care professionals. The resulting key themes are course of diabetes, information, person and context, body awareness and relationship with the health care provider. Meta-ethnography is a feasible tool for the meta-analysis of multilingual qualitative data and leads to a richer account.

Background and Objective: Pharmacists are now adopting a crucial role in the management of chronic illness in primary care, providing diabetes care and advice. This review aims to show whether a range of diabetes care interventions delivered by pharmacists is successful in improving adherence to medication., Methods: The studies reviewed formed a subgroup of a Cochrane review on interventions to improve adherence to medication in people with type 2 diabetes. Search terms were 'type 2 diabetes mellitus' and 'compliance' or 'adherence'. Studies were included if they assessed adherence to medical treatment specifically, rather than other aspects of self-management. Out of the 21 studies selected for review, five described an intervention delivered by a pharmacist., Results and Discussion: Two studies reported on attempts to improve adherence focused on the taking of medication. A system of reminders and packaging improved medication adherence, but measuring medicine taking through pill counts or Medication Event Monitoring System was not effective. Three studies evaluated pharmacist-led integrated management and education programmes designed to improve glycaemic control for under-served patient populations. They all succeeded in lowering glycated haemoglobin, but it remains unclear whether this resulted from improved patient adherence., Conclusion: This review indicates a potential benefit of pharmacist interventions to improve medication adherence in diabetes, especially in providing patient education.

Background: The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care., Methods/design: In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months) and following an agreed protocol change over 7% (months 13 to 18). Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside., Discussion: This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

Aims: In order to measure the effectiveness of interventions claiming to improve adherence in diabetes, valid measurement of adherence is necessary. Any measurement must first be based on a definition. This study aimed to identify and categorize definitions and measurements of adherence in living with diabetes, from a review of the literature., Methods: Publications were identified from the medline database. Adherence, compliance and concordance were used as terms in the search algorithm, along with diabetes, diabetes mellitus and treatment. Two hundred and ninety-three papers were identified. Abstracts of these papers were read by two researchers independently. Two hundred and thirty-nine papers did not contain definitions or measures of adherence and were discarded. Of the remaining 54 papers, 26 included definitions and 46 described measurements of adherence., Results: Definitions and measurements fell into five categories: coincidence of behaviour with professional advice, relationship as part of the process of care, outcome and process targets, taking the medication as prescribed and others. No single definition of adherence emerged. Many authors did not provide definitions of adherence. Glycated haemoglobin was the most common measurement of adherence, although this can raise problems., Conclusions: Research which claims to show an intervention has, or has not, improved adherence must be interpreted cautiously. Interventions which appear to fail may actually succeed in aspects of adherence which were not defined or measured in the study. Clinicians and researchers could use clear definitions and measurements, such as the ones presented in this review.

Aim: The aim of this paper is to present the development and evaluation of the Self-Efficacy Goal Achievement nursing intervention for type 2 diabetes., Background: Systematic reviews support the clinical effectiveness of diabetes self-management programmes that are collaborative, involve biomedical feedback and are goal focussed., Method: The self-efficacy goal achievement intervention comprises patient goal-setting consultations with practice nurses using the Diabetes Management Self-Efficacy Scale. The United Kingdom Medical Research Council framework for the evaluation of complex interventions by randomized controlled trial was used to develop and evaluate the intervention. The 'preclinical' study included literature analysis and findings from parallel studies. The 'phase I' study, carried out in spring 2003, was a small trial of the intervention, evaluation of its feasibility, identification of appropriate outcome measures for future trials and improvement of the components, with two nurses and eight patients., Findings: The 'preclinical' study supported continued intervention development. The 'phase I' intervention resulted in a mean reduction in participants' glycosylated haemoglobin of 0.93% between baseline and 3-months postintervention. It showed an increase in patient self-efficacy and some decline in patient diabetes treatment satisfaction. Qualitative data recorded therapeutically desirable behavioural changes in all participants. Follow-up consultations and goal evaluation were found to be important to patients. Nurses reported (i) reservations about the repeated use of components of the intervention, which were felt to be repetitive and restrictive; and (ii) the time commitment required to deliver the educational sessions., Conclusions: Most phase I components were effective in delivering a feasible nursing intervention. The intervention has been adjusted to remove the less effective components and enhance the more effective. The outcome measures were appropriate for the intervention. A phase II trial is being developed to further test both the intervention and research protocol for comparing the intervention to an alternative.

This 24-month exploratory study evaluated whether a 6-month programme supported by a trained external facilitator was feasible, acceptable and led to the adoption of a multidisciplinary approach to audit by secondary care staff. Undertaken in five acute hospital sites in the East Midlands UK, 22 multidisciplinary teams were randomised to either an intervention or control arm. Employing mixed methods, a range of outcomes, including collaborative behaviour, was measured. The intervention was feasible and acceptable to staff. Involvement in the facilitated programme had a positive impact on self-reported knowledge (P=0.000 post-intervention and at 4-months follow-up), skills (P=0.000 post-intervention and P=0.02 at 4-months follow-up) and attitudes (P<0.01 post-intervention), appeared to have some influence on improving self-reported (P<0.05 post-intervention) and observed collaborative behaviour (P=0.01) and led to better quality audit resulting in measurable improvements to care. Improved collaborative behaviour may have resulted from an increase in assertive behaviour by nurses. Research to test approaches to support teams to work effectively together is currently hampered by a lack of suitable research instruments and needs addressing before main (phase 111) trials are undertaken.

Background: Strategies to implement change in health professional performance have variable impact. A potential explanation is that the barriers to implementation are different in different settings and at different times. Change may be more likely if the strategies were specifically chosen to address the identified barriers., Objectives: To assess the effectiveness of strategies tailored to address specific, identified barriers to change in professional performance., Search Strategy: We searched the Cochrane Effective Practice and Organisation of Care Group (EPOC) specialised register and pending files until end of December 2002. English language articles only were included., Selection Criteria: Randomised controlled trials (RCTs) that reported objectively measured professional practice or health care outcomes in which at least one group received an intervention designed (or tailored) to address prospectively identified barriers to change., Data Collection and Analysis: Two reviewers independently extracted data and assessed quality. We also contacted study authors to obtain any missing information. Quantitative and qualitative analyses were undertaken., Main Results: We included 15 studies. For Comparison 1 (an intervention tailored to address identified barriers to change compared to no intervention or an intervention(s) not tailored to the barriers), there was no consistency in the results and the effect sizes varied both across and within studies.A meta-regression of a subset of the included studies, using a classical approach estimated a combined OR of 2.18 (95% CI: 1.09, 4.34), p = 0.026 in favour of tailored interventions. However, when a Bayesian approach was taken, meta-regression gave a combined OR of 2.27 (95% Credible Interval: 0.92, 4.75), which was not statistically significant., Authors' Conclusions: Interventions tailored to prospectively identify barriers may improve care and patient outcomes. However, from the studies included in this review, we were unable to determine whether the barriers were valid, which were the most important barriers, whether all barriers were identified and if they had been addressed by the intervention chosen. Based on the evidence presented in this review, the effectiveness of tailored interventions remains uncertain and more rigorous trials (including process evaluations) are needed. Further research needs to address explicitly the questions of identifying and addressing barriers.

Background: Research suggests adherence to treatment recommendations is low. In type 2 diabetes, which is a chronic condition slowly leading to serious vascular, nephrologic, neurologic and ophthalmological complications, it can be assumed that enhancing adherence to treatment recommendations may lead to a reduction of complications. Treatment regimens in type 2 diabetes are complicated, encompassing life-style adaptations and medication intake., Objectives: To assess the effects of interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus., Search Strategy: Studies were obtained from searches of multiple electronic bibliographic databases supplemented with hand searches of references. Date of last search: November 2002., Selection Criteria: Randomised controlled and controlled clinical trials, before-after studies and epidemiological studies, assessing changes in adherence to treatment recommendations, as defined in the objectives section, were included., Data Collection and Analysis: Two teams of reviewers independently assessed the trials identified for inclusion. Three teams of two reviewers assessed trial quality and extracted data. The analysis for the narrative part was performed by one reviewer (EV), the meta-analysis by two reviewers (EV, JW)., Main Results: Twentyone studies assessing interventions aiming at improving adherence to treatment recommendations, not to diet or exercise recommendations, in people living with type 2 diabetes in primary care, outpatient settings, community and hospital settings, were included. Outcomes evaluated in these studies were heterogeneous, there was a variety of adherence measurement instruments. Nurse led interventions, home aids, diabetes education, pharmacy led interventions, adaptation of dosing and frequency of medication taking showed a small effect on a variety of outcomes including HbA1c. No data on mortality and morbidity, nor on quality of life could be found., Authors' Conclusions: Current efforts to improve or to facilitate adherence of people with type 2 diabetes to treatment recommendations do not show significant effects nor harms. The question whether any intervention enhances adherence to treatment recommendations in type 2 diabetes effectively, thus still remains unanswered.

We assessed the feasibility of developing a virtual diabetes clinic for young people, using the Internet. The proposed content of the site would be based on self-efficacy theory, aiming to develop confidence in self-management of diabetes. A questionnaire about the proposed Website was delivered to 72 patients who attended a young person's outpatient clinic in a district hospital. Thirty-nine replies were received, a response rate of 54%. The mean age of the respondents was 13 years. A positive attitude to the potential clinic was reported by 95% of respondents. The items rated as most useful were: quick and easy access to up-to-date information about diabetes; the opportunity to ask an expert; good graphics; easy navigation; interactivity. Responses to open questions indicated that 24-hour access and anonymity in asking questions were also valued. A virtual clinic appears to be a possible method of health-care delivery to young people with diabetes.

Objectives: This study measured the extent to which a systematic approach was used to select criteria for audit, and identified problems in using such an approach with potential solutions., Design: A questionnaire survey using the Audit Criteria Questionnaire (ACQ), created, piloted, and validated for the purpose. Possible ACQ scores ranged from 0 to 1, indicating how systematically the criteria had been selected and how usable they were., Setting: A stratified random sample of 10 audit leads in each of 83 randomly selected NHS trusts and all practices in each of 11 randomly selected primary care audit group areas in England and Wales., Participants: Audit leads of ongoing audits in each organisation in which a first data collection had started less than 12 months earlier and a second data collection was not completed., Main Outcome Measures: ACQ scores, problems identified in the audit criteria selection process, and solutions found., Results: The mean ACQ score from all 83 NHS trusts and the 11 primary care audit groups was 0.52 (range 0.0-0.98). There was no difference between mean ACQ scores for criteria used in audits on clinical (0.51) and non-clinical (0.52) topics. The mean ACQ scores from nationally organised audits (0.59, n=33) was higher than for regional (0.51, n=21), local (0.53, n=77), or individual organisation (0.52, n=335) audits. The mean ACQ score for published audit protocols (0.56) was higher than for locally developed audits (0.49). There was no difference in ACQ scores for audits reported by general practices (0.49, n=83) or NHS trusts (0.53, n=383). Problems in criteria selection included difficulties in coordination of staff to undertake the task, lack of evidence, poor access to literature, poor access to high quality data, lack of time, and lack of motivation. Potential solutions include investment in training, protected time, improved access to literature, support staff and availability of published protocols., Conclusions: Methods of selecting review criteria were often less systematic than is desirable. Published usable audit protocols providing evidence based review criteria with information on their provenance enable appropriate review criteria to be selected, so that changes in practice based on these criteria lead to real improvement in quality rather than merely change. The availability and use of high quality audit protocols would be a valuable contribution to the evolution of clinical governance. The ACQ should be developed into a tool to help in selecting appropriate criteria to increase the effectiveness of audit.

Background: Chronic heart failure is a common clinical condition with high morbidity and mortality. Despite the evidence that appropriate treatment with angiotensin-converting enzyme inhibitors can improve morbidity, primary care studies show that patients with heart failure are incorrectly diagnosed and inadequately treated., Aim: To explore general practitioners' accounts of their management of patients with heart failure and identify the perceived obstacles to diagnosis and management., Methods: We conducted this qualitative study using semi-structured interviews in 18 general practices. The practices were stratified on the basis of size, location, and the level of practice development. The interviews were based on a schedule of open questions based on the literature on diagnosis and management of patients with heart failure. Transcriptions of the audiotaped interviews were independently analysed by two researchers and analysis was based on open coding using a constant comparative approach. Categories were reduced to major themes., Results: General practitioners suspect heart failure when patients present with breathlessness or ankle oedema. Many general practitioners reported that they would diagnose heart failure after respiratory examination and a positive finding of basal crepitations. Many general practitioners arrange a chest X-ray to establish the diagnosis and some arrange an electrocardiogram. A few general practitioners mentioned that they diagnosed heart failure with a trial of diuretics. Obstacles to diagnosis were mentioned by most general practitioners and included lack of facilities for appropriate investigations (especially echocardiography) and lack of time and expertise. Obstacles to management included lack of time, high cost of drugs, difficulty with diagnosis, selection bias towards younger patients and not having the confidence to initiate angiotensin-converting enzyme inhibitors. Many general practitioners were unaware of the impact angiotensin-converting enzyme inhibitors can have on morbidity and mortality., Conclusions: Although symptoms of heart failure are not sufficiently specific for diagnosing patients with heart failure, many general practitioners in European countries treat people with suspected heart failure on the basis of symptoms and signs alone. This study has identified many obstacles to the diagnosis and management of heart failure that may explain why patients are inadequately managed in primary care. Specific implementation strategies need to be tailored to overcome these obstacles., (Copyright 2002 European Society of Cardiology)

Objective: To identify associations between the characteristics of general practitioners and practices, and patients' evaluations of the availability of general practice., Design: Written surveys completed by patients., Setting: General practice care in nine European countries: Denmark, Germany, The Netherlands, Norway, UK, Belgium (Flanders and Wallonia), Switzerland, Slovenia and Spain., Study Participants: 15996 adult patients consecutively visiting the general practitioner (response rates per country varied between 47 and 89%)., Main Measures: The Europep instrument to assess patients' evaluations of five aspects of the availability of general practice care: (1) getting an appointment, (2) getting through on the phone, (3) being able to speak to the practitioner on the telephone, (4) waiting time in the waiting room, and (5) providing quick services for urgent health problems. Each general practitioner recorded age, sex, number of years in the practice, number of practitioners and other care providers in the practice, and urbanization level of the practice., Results: Patients' more positive evaluations were associated with fewer general practitioners in the practice, except for quick services for urgent health problems (range of conditional overall odds ratios, 1.69-2.02). In addition, a number of significant unconditional overall odds ratios were found, particularly those related to the number of general practitioners' working hours and the number of care providers in the practice. None of the associations was found consistently in all countries., Conclusion: Patients favour small practices and full-time general practitioners, which contradicts developments in general practice in many countries. Policy makers should consider how the tensions between patients' views and organizational developments can be solved.

Low compliance to prescribed medical interventions is an ever present and complex problem, especially for patients with a chronic illness. With increasing numbers of medications shown to do more good than harm when taken as prescibed, low compliance is a major problem in health care. Relevant studies were retrieved through comprehensive searches of different database systems to enable a thorough assessment of the major issues in compliance to prescribed medical interventions. The term compliance is the main term used in this review because the majority of papers reviewed used this term. Three decades have passed since the first workshop on compliance research. It is timely to pause and to reflect on the accumulated knowledge. The enormous amount of quantitative research undertaken is of variable methodological quality, with no gold standard for the measurement of compliance and it is often not clear which type of non-compliance is being studied. Many authors do not even feel the need to define adherence. Often absent in the research on compliance is the patient, although the concordance model points at the importance of the patient's agreement and harmony in the doctor-patient relationship. The backbone of the concordance model is the patient as a decision maker and a cornerstone is professional empathy. Recently, some qualitative research has identified important issues such as the quality of the doctor-patient relationship and patient health beliefs in this context. Because non-compliance remains a major health problem, more high quality studies are needed to assess these aspects and systematic reviews/meta-analyses are required to study the effects of compliance in enhancing the effects of interventions.

Objectives: To identify the desirable characteristics of review criteria for quality improvement and to determine how they should be selected., Background: Review criteria are the elements against which quality of care is assessed in quality improvement. Use of inappropriate criteria may impair the effectiveness of quality improvement activities and resources may be wasted in activities that fail to facilitate improved care., Methods: A two round modified Delphi process was used to generate consensus amongst an international panel of 38 experts. A list of 40 characteristics of review criteria, identified from literature searches, was distributed to the experts who were asked to rate the importance and feasibility of each characteristic. Comments and suggestions for characteristics not included in the list were also invited., Results: The Delphi process refined a comprehensive literature based list of 40 desirable characteristics of review criteria into a more precise list of 26 items. The expert consensus view is that review criteria should be developed through a well documented process involving consideration of valid research evidence, possibly combined with expert opinion, prioritisation according to health outcomes and strength of evidence, and pilot testing. Review criteria should also be accompanied by full clear information on how they might be used and how data might be collected and interpreted., Conclusion: The desirable characteristics for review criteria have been identified and will be of use in the development, evaluation, and selection of review criteria, thus improving the cost effectiveness of quality improvement activities in healthcare settings.

Background: Various methods are available for implementing change in the clinical behaviour of general practitioners (GPs). Although passive dissemination of information is generally ineffective, other methods can be variably effective. Few studies have investigated the impact of tailored methods., Aim: To determine whether methods tailored to overcome obstacles to change using psychological theories are more effective than dissemination alone in the implementation of guidelines for depression among GPs., Design of Study: Randomised controlled trial., Setting: Sixty general practices in England; 30 GPs in the control group, 34 in the intervention group., Method: Practitioners identified patients presenting with depression before and after the implementation of guidelines (control group n = 192 in the first data collection, n = 181 in the second; intervention group n = 210 in the first data collection and n = 197 in the second). The main outcome measures were: record of adherence to guideline recommendations in clinical records; proportion of patients with Beck Depression Inventory (BDI) score less than 11 at 16 weeks after diagnosis., Results: In comparison with the control group, in the group of GPs receiving tailored implementation, there were increases in the proportions of patients assessed for suicide risk. In the intervention group, the proportion of patients with BDI scores of less than 11 at 16 weeks increased., Conclusion: Obstacles to implementation can be identified and strategies tailored to address them. The findings indicate a new approach for research to understand and develop methods of implementation.

Background: Patients' evaluations can be used to improve health care and compare general practice in different health systems., Aim: To identify aspects of general practice that are generally evaluated positively by patients and to compare opinions of patients in different European countries on actual care provision., Method: An internationally-validated questionnaire was distributed to and completed by patients in 10 European countries. A stratified sample of 36 practices per country, with at least 1080 patients per country, was included. A set of 23 validated questions on evaluations of different aspects of care was used, as well as questions on age, sex, overall health status, and frequency of visiting the GP., Results: The patient sample included 17,391 patients in 10 different countries; the average response rate was 79% (range = 67% to 89%). In general, patients visiting their general practitioner (GP) were very positive about the care provided. For most of the 23 selected aspects of care more than 80% viewed care as good or excellent; in particular, keeping records confidential, GP listening to patients, time during consultations, and quick services in case of urgent problems were evaluated positively. Patients were relatively negative about organisational aspects of care. The evaluations in different countries were largely similar, with some interesting differences; for instance, service and organisational aspects were evaluated more positively in fee-for-service health systems., Conclusions: Patients in Europe are positive about general practice but improvements in practice management in some countries are requested. More research is needed to study the complex field of differences in expectations and evaluations between countries with different health systems.

The effect of electrical stimulation on protease activity (at approx. 3 h postmortem), sensory tenderness scores and shear force was determined on M. longissimus samples from three Bos indicus genotypes (0% Hereford, 50% Brahman×Hereford and 100% Brahman). The samples were divided and aged for 1 or 30 days. Electrical stimulation resulted in a general reduction in calpastatin activity suggesting that it accelerated proteolysis. Calpastatin activity increased commensurate with increasing Bos indicus content. Several significant interactions were shown, the most relevant of these was the interaction between Bos indicus content×electrical stimulation. In contrast to the other genotypes, calpain I and calpain II activities were shown to increase (significant for calpain II only) following stimulation in the purebred Brahmans (100%). There was a significant reduction in tenderness with increasing Bos indicus content. However, breed differences in shear force were reduced by electrical stimulation. The improvement in shear force following ageing was smaller for stimulated carcasses compared to the controls. This tends to reinforce the premise that electrical stimulation accelerates proteolysis. The results of this study show clear genotypic differences in proteolytic activity and tenderness. However, electrical stimulation can be employed to reduce breed differences in tenderness of the M. longissimus.

Background: A growing number of new ways of organising services across the primary/secondary interface are being introduced and evaluated. The principal motive for such reorganisation is to improve the efficiency of health care. However, unless the impact of the new services on patients is investigated and taken into account, it is possible that patients' reactions could be negative, a factor that could lead to unexpected consequences in the use and costs of services., Objective: To develop a measure of patients' attitudes towards care across the interface between primary and secondary care., Design: Generation of questions to be included in the measure from a qualitative study of patients' experiences of care across the interface; administration of pilot versions of the measure to samples of patients referred to secondary care; refinement of questions guided by analysis of response patterns, principal components analysis and internal consistency; administration of the final version of the patient career diary in complete form retrospectively to patients referred to secondary care, and one section alone to patients attending outpatient departments for follow up appointments. Face validity was assessed by analysis of open comments in a sample of 50 diaries, and review of the diary by 34 health professionals. Construct validity was assessed by investigation of levels of correlation between components of each section of the diary and the components of the healthcare section overall., Setting: In the final field test, patients were attending various hospital services, including cardiology, dermatology, neurology, gynaecology, general surgery, general medicine, ophthalmology, trauma and orthopaedics, and gastroenterology., Results: The final version of the diary included 109 questions in seven sections: general practitioner (GP) visits and referral, other GP visits, first outpatient visit, other outpatient visits, inpatient stay and discharge, care after discharge, and care overall. Response rates were poor for retrospective completion of the entire diary, but excellent when a section was given separately. Principal components analysis confirmed that components relating to issues identified as important to patients in the qualitative study had been included in the diary. Levels of internal consistency were good, and comments of patients and health professionals supported validity., Conclusion: The patient career diary is a valid and reliable measure of patients' attitudes to care across the interface. It should be given in sections to ensure adequate response rates, and is suitable for use in the evaluation or quality of patterns of care across the interface. In future, the impact on patients of new ways of organising services across the interface should be investigated by use of measures such as the patient career diary.

Objectives: To discover the views of patients about their experiences across the interface between primary and secondary health care, including referral from general practitioners, outpatient and inpatient care, discharge, and aftercare., Design: A qualitative study involving individual and focus group interviews of patients and interviews of carers., Subjects: 33 patients who had attended at least one outpatient appointment or had been an inpatient between two and four months previously, and eight carers of patients with chronic conditions., Setting: Three acute hospitals and one community health service in Leicestershire., Main Outcome Measures: Common themes in the views of patients and carers towards their experiences of care., Results: Five themes emerged. The first four were: "getting in" (access to appropriate care), "fitting in" (orientation of care to the patient's requirements), "knowing what's going on" (provision of information), and "continuity" (continuity of staff and coordination and communication among professionals). The fifth theme was "limbo" (difficulty in making progress through the system), which was influenced by failures in care in relation to the other four themes., Conclusions: The concept of progress is central to patients' views of care. It involves both progress through the healthcare system and progress towards recovery or adjustment to an altered health state. Patients' views on how well they progress through the healthcare system may be an appropriate indicator for monitoring health service performance.

Background and Objectives: Improving the sensitivity of general practice to patients' needs demands a good understanding of patients' expectations and priorities in care provision. Insight into differences in expectations of patients in different cultures and health care systems may support decision-making on desirable models for care provision in general practice. An international study was conducted to determine priorities of patients in general practice care: which views do patients in different countries have in common and which views differ?, Methods: Written surveys in general practices in the UK, Norway, Sweden, Denmark, The Netherlands, Germany, Portugal and Israel were performed. Samples of patients from at least 12 practices per country, stratified according to area and type of practice, were included. Patients rated the importance of 38 different aspects of general practice care, selected on the basis of literature analysis, qualitative studies and consensus discussions. Rankings between countries were compared., Results: A total number of 3540 patients (response rate on average 55%) completed the questionnaire. Patients in different countries had many opinions in common. Aspects that got the highest ranking were: getting enough time during the consultation; quick services in case of emergencies; confidentiality of information on patients; telling patients all they want to know about their illness; making patients feel free to talk about their problems; GPs going to courses regularly; and offering preventive services. However, differences between opinions of patients in different countries were also found for some of the selected aspects. A confounding effect of patients' characteristics may have played a role in these differences., Discussion: The study provides information on what patients expect of and value in general practice care. It shows that patients in different cultures and health care systems may have different views on some aspects of care, but most of all that they have many views in common, particularly as far as doctor-patient communication and accessibility of services are concerned.

Objectives: To evaluate a programme in which quality improvement was facilitated, based on principles of total quality management, in primary healthcare teams, and to determine its feasibility, acceptability, effectiveness, and the duration of its effect., Method: Primary healthcare teams in Leicestershire (n = 147) were invited to take part in the facilitated programme. The programme comprised seven team meetings, led by a researcher, plus up to two facilitated meetings of quality improvement subgroups, appointed by each team to consider specific quality issues., Outcome Measures: To assess the effect and feasibility of the programme on improving the quality of care provided, the individual quality improvement projects undertaken by the teams were documented and opportunities for improvement were noted at each session by the facilitator. The programme's acceptability was assessed with questionnaires issued in the final session to each participant. To assess the long term impact on teams, interviews with team members were conducted 3 years after the programme ended., Results: 10 of the 27 teams that initially expressed interest in the programme agreed to take part, and six started the programme. Of these, five completed their quality improvement projects and used several different quality tools, and three completed all seven sessions of the programme. The programme was assessed as appropriate and acceptable by the participants. Three years later, the changes made during the programme were still in place in three of the six teams. Four teams had decided to undertake the local quality monitoring programme, resourced and supported by the Health Authority., Conclusions: The facilitated programme was feasible, acceptable, and effective for a few primary healthcare teams. The outcomes of the programme can be sustained. Research is needed on the characteristics of teams likely to be successful in the introduction and maintenance of quality improvement programmes.

This qualitative study explored those behaviours of a general practitioner which were used by patients in their evaluations of 14 aspects of general practice care. Thirty patients were interviewed immediately after visiting their general practitioner. Interview transcripts were analyzed by two authors, who independently marked general practitioners' behaviours used by patients. Then, these text fragments were categorised into task or affective behaviours according to an existing taxonomy of doctor behaviour in consultations. The results showed that patients reported using task oriented behaviours when they evaluated task oriented aspects of general practice care. However, when they evaluated affective aspects they reported using both affective behaviours and task behaviours, although the latter to a lesser extent. The evaluations of "tell you all you wanted to know about your illness", "explain the purpose and the course of the treatment", "pay attention to your feelings" and "kind and attentive" are clearly linked to specific general practitioners' behaviour. Therefore, evaluations of these aspects can be interpreted straightforwardly. Evaluation of the aspects "GP understands you", "having faith in your GP" and "were you involved in decisions about your medical treatment?" were based on a large variety of physician behaviours which may lead to interpretation problems. Thus, this study gives some important considerations for a better understanding of patients' evaluations of general practice care.

Insight into patients' priorities with respect to health care should complement the views of professionals and policy makers on what is thought to be appropriate health care. To determine the strengths and weaknesses of general practice care from patients' perspectives written surveys were performed among patients in Denmark, Germany, Israel, Netherlands, Norway, Portugal, Sweden and United Kingdom (n = 3540). The potential quality problems identified were spread over the different countries: the low involvement of general practitioners in out-of-hours services in Portugal; the low provision of routine screening in Sweden, Norway and The Netherlands; the lack of a defined patient population in Germany; the lack of a formal gatekeeper role to secondary care in general practice in Germany and Sweden; and the low number of home visits in Sweden.

Background: Since 1991, all general practices have been encouraged to undertake clinical audit. Audit groups report that participation is high, and some local surveys have been undertaken, but no detailed national survey has been reported., Aim: To determine audit activities in general practices and the perceptions of general practitioners (GPs) regarding the future of clinical audit in primary care., Method: A questionnaire on audit activities was sent to 707 practices from 18 medical audit advisory group areas. The audit groups had been ranked by annual funding from 1992 to 1995. Six groups were selected at random from the top, middle, and lowest thirds of this rank order., Results: A total of 428 (60.5%) usable responses were received. Overall, 346 (85%) responders reported 125.7 audits from the previous year with a median of three audits per practice. There was no correlation between the number of audits reported and the funding per GP for the medical audit advisory group. Of 997 audits described in detail, changes were reported as 'not needed' in 220 (22%), 'not made' in 142 (14%), 'made' in 439 (44%), and 'made and remeasured' in 196 (20%). Thus, 635 (64%) audits were reported to have led to changes. Some 853 (81%) of the topics identified were on clinical care. Responders made 242 (42%) positive comments on the future of clinical audit in primary care, and 152 (26%) negative views were recorded., Conclusion: The level of audit activity in general practice is reasonably high, and most of the audits result in change. The number of audits per practice seems to be independent of the level of funding that the medical audit advisory group has received. Although there is room for improvement in the levels of effective audit activity in general practice, continued support by the professionally led audit groups could enable all practices to undertake effective audit that leads to improvement in patient care.

Background: Patient views are important in the evaluation of the quality of health care. The use of surveys needs to be evaluated to determine their cost-effectiveness and benefits., Objectives: To determine the costs of conducting patient opinion surveys in general practice and to find out how effective patient surveys are in stimulating changes which are beneficial for patient care., Method: Postal questionnaire to all 102 medical audit advisory groups (MAAGs) and 98 family health services authorities (FHSAs) in England and Wales, followed by postal questionnaire to 302 general practices reported to have conducted surveys, sampled by the type or questionnaire used. Numbers of MAAGs and FHSAs reporting surveys in general practice; types of questionnaire used; estimated costs; changes made; and benefits identified were measured., Results: Eighty-five (83%) MAAGs and 75 (77%) FHSAs responded. One hundred and fifty-four (96%) of MAAGs or FHSAs reported survey activity. Types of questionnaire used were 1) designed by the practice, 2) designed by the MAAG or FHSA, possibly in collaboration with a practice, or 3) standard 'off-the-shelf'. One hundred and thirty-three (44%) practices responded. Total costs to a practice of conducting a survey ranged from nothing to over 2200 Pounds. Questionnaires designed by the practice are likely to be more costly than other designs. Some practices had surveys provided free of charge by MAAG or FHSA. Sixty-one per cent of practices said changes had been implemented and a further 22% of practices said changes were planned. The most common change was to appointment systems. Benefits were identified for patients, staff, the practice, the MAAG or FHSA and the NHS. Surveys also brought benefits in relationships and understanding. Only 8.2% of practices felt the costs of surveys outweighed the benefits., Conclusions: Many practices are surveying patients' opinions. Surveys can be costly but MAAGs and FHSAs can provide expertise and resources. Surveys using any of the types of questionnaire are likely to lead to changes and identifiable benefits. Benefits of surveys are perceived by the majority of practices to outweigh the costs.

Objectives--To determine the role of medical audit advisory groups in audit activities in general practice. Design--Postal questionnaire survey. Subjects--All 104 advisory groups in England and Wales in 1994. Main measures--Monitoring audit: the methods used to classify audits, the methods used by the advisory group to collect data on audits from general practices, the proportion of practices undertaking audit. Directing and coordinating audits: topics and number of practices participating in multipractice audits. Results--The response rate was 86-5%. In 1993-4, 54% of the advisory groups used the Oxfordshire or Kirklees methods for classifying audits, or modifications of them. 99% of the advisory groups collected data on audit activities at least once between 1991-2 and 1993-4. Visits, questionnaires, and other methods were used to collect information from all or samples of practices in each of the advisory group's areas. Some advisory groups used different methods in different years. In 1991-2, 57% of all practices participated in some audit, in 1992-3, 78%, and in 1993-4, 86%. 428 multipractice audits were identified. The most popular topic was diabetes. Conclusions--Advisory groups have been active in monitoring audit in general practice. However, the methods used to classify and collect information about audits in general practices varied widely. The number of practices undertaking audit increased between 1991-2 and 1993 1. The large number of multipractice audits supports the view that the advisory groups have directed and coordinated audit activities. This example of a national audit programme for general practice may be helpful in other countries in which the introduction of quality assurance is being considered.

Ewes with permanent phyto-estrogenic infertility show oestrus less regularly than normal ewes, and the present study examines the extent to which this results from abnormal ovarian function. Forty-nine affected ewes and 53 controls were run with rams fitted with marking crayons and harnesses, and crayon marks were recorded and laparoscopy performed at weekly intervals for 3 weeks. Fewer affected ewes showed oestrus accompanied by ovulation (28 v. 49, P less than 0.001), and four of these affected ewes had a second ovulation during the experiment. More of the ovulations observed in affected ewes were unaccompanied by behavioural oestrus than in controls (8 out of 38 v. 2 out of 50; P less than 0.05). Six affected ewes had no corpus luteum or oestrus, and five of these had adhesions over the genitalia. Hydrops uteri in five other affected ewes was accompanied by prolonged maintenance of the corpus luteum. Some other abnormalities were also observed. In a second study, plasma progesterone concentrations were measured twice daily in 12 affected ewes which were run with rams. Five ewes had oestrous cycles of abnormal duration (two of more than 23 days, two of 21 days, and one of 11 days), and these were accompanied by plasma progesterone patterns different from those of the ewes with an oestrous cycle duration of 16-18 days. It is concluded that the irregular oestrous cycles in affected ewes are due mainly to abnormal life span and progesterone secretion by the corpus luteum, which in turn largely result from changes in the uterus.

Luteinizing hormone (LH) concentration was measured in the jugular plasma of six groups of ovariectomized ewes which were fed oestrogenic clover (Trifolium subterranean L. Gray cv. Yarloop) for 3 days. Ewes in groups B, D and F received an injection of oestradiol-17beta (E2) 24 h after first being offered clover, whilst ewes in groups A, C and E received no oestrogen treatment. Following the initial ingestion of clover, plasma LH concentrations for all groups fell within 3 h and then increased significantly. Each subsequent feeding of clover usually resulted in a temporary decrease and then an elevation of the LH concentrations. When ewes in groups B, D and F were injected with E2, LH concentrations fell and remained low for approximately 9 h, then increased to a peak of 72-3 +/- 10-4 ng/ml within 5 h. The LH concentrations remained elevated for a period of about 12 h. The present paper indicates that the ingestion of oestrogenic clover by ovariectomized ewes results in a depression and then a release of LH, and that this release does not appear to deplete the pituitary of LH or cause refractoriness to an oestrogenic stimulus.

Neither routine experimental procedures, including vascular cannulation and venipuncture, nor starvation or disturbance caused significant fluctuations in luteinizing hormone (LH) concentrations in ovariectomized ewes. Samples obtained at 5-min intervals revealed episodic LH releases occurring every 10-35 min. Hourly sampling over 3 days revealed large LH variations but no distinct diurnal variation.