Evaluating a systematic voiding programme for patients with urinary incontinence after stroke in secondary care using soft systems analysis and Normalisation Process Theory: findings from the ICONS case study phase.

BACKGROUND: Urinary incontinence (UI) affects between 40 and 60% of people in hospital after stroke, but is often poorly managed in stroke units. OBJECTIVES: To inform an exploratory trial by three methods: identifying the organisational context for embedding the SVP; exploring health professionals' views around embedding the SVP and measuring presence/absence of UI and frequency of UI episodes at baseline and six weeks post-stroke. DESIGN: A mixed methods single case study included analysis of organisational context using interviews with clinical leaders analysed with soft systems methodology, a process evaluation using interviews with staff delivering the intervention and analysed with Normalisation Process Theory, and outcome evaluation using data from patients receiving the SVP and analysed using descriptive statistics. SETTING: An 18 bed acute stroke unit in a large Foundation Trust (a 'not for profit' privately controlled entity not accountable to the UK Department of Health) serving a population of 370,000. PARTICIPANTS: Health professionals and clinical leaders with a role in either delivering the SVP or linking with it in any capacity were recruited following informed consent. Patients were recruited meeting the following inclusion criteria: aged 18 or over with a diagnosis of stroke; urinary incontinence (UI) as defined by the International Continence Society; conscious; medically stable as judged by the clinical team and with incontinence classified as stress, urge, mixed or 'functional'. All patients admitted to the unit during the intervention period were screened for eligibility; informed consent to collect baseline and outcome data was sought from all eligible patients. RESULTS: Organisational context: 18 health professionals took part in four group interviews. Findings suggest an environment not conducive to therapeutic continence management and a focus on containment of UI. Embedding the SVP into practice: 21 nursing staff took part in six group interviews. Initial confusion gave way to embedding of processes facilitated by new routines and procedures. Patient outcome: 43 patients were recruited; 28 of these commenced the SVP. Of these, 6/28 (21%) were continent at six weeks post-stroke or discharge. CONCLUSION: It was possible to embed the SVP into practice despite an organisational context not conducive to therapeutic continence care. Recommendations are made for introducing the SVP in a trial context.

A cluster randomised controlled trial of a web based decision aid to support parents' decisions about their child's Measles Mumps and Rubella (MMR) vaccination.

OBJECTIVE: To evaluate the effectiveness of a web based decision aid versus a leaflet versus, usual practice in reducing parents' decisional conflict for the first dose MMR vaccination decision. The, impact on MMR vaccine uptake was also explored. DESIGN: Three-arm cluster randomised controlled trial. SETTING: Fifty GP practices in the north of, England. PARTICIPANTS: 220 first time parents making a first dose MMR decision. INTERVENTIONS: Web, based MMR decision aid plus usual practice, MMR leaflet plus usual practice versus usual practice only, (control). MAIN OUTCOME MEASURES: Decisional conflict was the primary outcome and used as the, measure of parents' levels of informed decision-making. MMR uptake was a secondary outcome. RESULTS: Decisional conflict decreased post-intervention for both intervention arms to a level where, parents could make an informed MMR decision (decision aid: effect estimate=1.09, 95% CI -1.36 to -0.82; information leaflet: effect estimate=-0.67, 95% CI -0.88 to -0.46). Trial arm was significantly, associated (p<0.001) with decisional conflict at post-intervention. Vaccination uptake was 100%, 91%, and 99% in the decision aid, leaflet and control arms, respectively (χ(2) (1, N=203)=8.69; p=0.017). Post-hoc tests revealed a statistically significant difference in uptake between the information leaflet, and the usual practice arms (p=0.04), and a near statistically significant difference between the, decision aid and leaflet arms (p=0.05). CONCLUSIONS: Parents' decisional conflict was reduced in both, the decision aid and leaflet arms. The decision aid also prompted parents to act upon that decision and, vaccinate their child. Achieving both outcomes is fundamental to the integration of immunisation, decision aids within routine practice. TRIAL REGISTRATION: ISRCTN72521372.

A multi-professional UK wide survey of undergraduate continence education.

OBJECTIVES: Findings from national audits and enquiries continue to report that care for patients with continence problems is often substandard and inadequate education is often cited as one of the probable causes. These factors combined with the forecasted increase in the number of people with incontinence prompted us to undertake a survey of all UK Higher Education Institutes (HEIs) to establish the amount of undergraduate continence education within relevant healthcare programs--medical, adult nursing, mental health nursing, learning disabilities nursing, children's nursing, midwifery, physiotherapy, and occupational therapy. DESIGN: An on line questionnaire targeted course program leads (n = 362) in all 86 HEIs in which undergraduate professional healthcare programs were provided (n = 362). MAIN OUTCOME MEASURE: Eighty-six HEIs were approached, 85 agreed to participate in the survey. A response rate of 81% (n = 294/362 programs) was obtained: 14% (n = 42) of respondents reported that there was no continence-related education within their undergraduate program. The mean number of hours was 4.7 (SD 4.3), and ranged from 2.5 (SD 3.5) hr (Occupational Therapy) to 7.3 (SD 4.8) hr (Adult Nursing). CONCLUSION: The survey results indicate that the amount of undergraduate education has changed little. Further research is needed to identify the most appropriate methods of delivering continence education and translate knowledge into improved patient outcomes. Adequate undergraduate continence education directed by the General Medical Council, Royal Colleges and Health Professional Council is required.

Systematic review and evaluation of methods of assessing urinary incontinence.

OBJECTIVES: To identify and synthesise studies of diagnostic processes of urinary incontinence and to construct an economic model to examine the cost-effectiveness of simple, commonly used primary care tests. DATA SOURCES: The electronic databases MEDLINE (1966--2002), CINAHL (1982--2002) and EMBASE (1980--2002). REVIEW METHODS: Studies were selected and assessed using the Quality Assessment of Diagnostic Studies (QUADAS) tool. Studies that reported the results of applying the same diagnostic procedure using the same threshold value (cut-off) were pooled using a random effects meta-analysis model to produce pooled estimates of sensitivity, specificity and diagnostic odds ratio together with 95% confidence intervals. RESULTS: In total, 6009 papers were identified from the literature search, of which 129 were deemed relevant for inclusion in the review, and these papers compared two or more diagnostic techniques. The gold-standard diagnostic test for urinary incontinence with which each reference test was compared was multichannel urodynamics. In general, reporting in the primary studies was poor; there was a lack of literature in the key clinical areas and minimal literature dealing with diagnosis in men. Only a limited number of studies could be combined or synthesised, providing the following results when compared with multichannel urodynamics. A clinical history for diagnosing urodynamic stress incontinence (USI) in women was found to have a sensitivity of 0.92 and specificity of 0.56 and for detrusor overactivity (DO) a sensitivity of 0.61 and specificity of 0.87. For validated scales, question 3 of the Urogenital Distress Inventory was found to have a sensitivity of 0.88 and specificity of 0.60. Seven studies compared a pad test with multichannel urodynamics; however, four different pad tests were studied and therefore it was difficult to draw any conclusions about diagnostic accuracy. Of the four studies comparing urinary diary with multichannel urodynamics, only one presented data in a format that allowed sensitivity and specificity to be calculated. Their reported values of 0.88 and 0.83 suggest that a urinary diary may be effective in the diagnosis of DO in women. Examination of the incremental cost-effectiveness of three primary care tests used in addition to history found that the diary had the lowest cost-effectiveness ratio of between pound 35 and pound 77 per extra unit of effectiveness (or case diagnosed). Imaging by ultrasound to determine leakage was found to be effective in the diagnosis of USI in women, with a sensitivity of 0.94 and specificity of 0.83. CONCLUSIONS: This is the first systematic review of methods for diagnosing urinary incontinence. As reporting of the primary studies was poor, clinical interpretation was often difficult because few studies could be synthesised and conclusions made. The report found that a large proportion of women with USI can be correctly diagnosed in primary care from clinical history alone. On the basis of diagnosis the diary appears to be the most cost-effective of the three primary care tests (diary, pad test and validated scales) used in addition to clinical history. Ultrasound imaging may offer a valuable alternative to urodynamic investigation. The clinical stress test is effective in the diagnosis of USI. Adaptation of such a test so that it could be performed in primary care with a naturally filled bladder may prove clinically useful. If a patient is to undergo an invasive urodynamic procedure, multichannel urodynamics is likely to give the most accurate result in a secondary care setting. There is a dearth of literature on the diagnosis of urinary incontinence in men, with no studies meeting the study criteria for data extraction in the diagnosis of bladder outlet obstruction. There is a need for large-scale, high-quality primary studies evaluating the use of a number of diagnostic methods in a primary care setting to be undertaken so that the results of this systematic review can be verified or not. Such studies should include not only an assessment of clinical effectiveness, in this case diagnostic accuracy, but also an assessment of costs and quality of life/satisfaction to inform future health policy decisions. Studies carried out should be reported to a better standard. The recommendations of the Standards for Reporting Diagnostic Accuracy (STARD) initiative should be followed to ensure the accuracy and completeness of reporting design and results.

Tailored interventions to overcome identified barriers to change: effects on professional practice and health care outcomes.

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.

Are audits wasting resources by measuring the wrong things? A survey of methods used to select audit review criteria.

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.

Involving patients in treatment decisions: can we learn from clinical trials?

The delivery of information to patients with cancer is a primary responsibility of health professionals and it may improve patients' satisfaction with their involvement in treatment decisions. Clinical trials often involve more written and verbal information for patients. All patients who were receiving chemotherapy in Leicestershire during a 2-week period were asked to complete a questionnaire. The responses of clinical trial and non-trial patients were compared. Clinical trial patients were significantly more likely to have been informed about alternative treatment options and to feel that they had taken part in the decision to undergo chemotherapy. They were also significantly more likely to have received written and verbal information about diagnosis and treatment from a hospital nurse, and were more willing to approach a nurse with future questions. If greater patient participation in treatment decisions is advocated, more written and verbal information and closer involvement of hospital nurses should be considered for all forms of chemotherapy.

Expert consensus on the desirable characteristics of review criteria for improvement of health care quality.

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.

The Data Protection Act (1998): implications for health researchers.

AIMS: This paper reports on the methods used in two studies to obtain access to subjects to comply with the common law duty of confidence laid out in the Data Protection Act (1998) and discusses the researchers' problems in interpreting the procedures. RATIONALE: The amendments to the United Kingdom (UK) Data Protection Act (1998) are causing confusion within the health service and academic institutions. There is a need to balance patient confidentiality with the requirement to conduct vital, unbiased research in which health service professionals are not subject to ethical dilemmas. This paper examines the recruitment methods used in two studies in which the researchers' attempts to adhere to the requirements lengthened the study costs and may have produced less reliable results. METHODS: The methodological difficulties in two studies are presented. In Study 1, the difficulties encountered when the Multicentre Research Ethics Committee refused permission for researchers to recruit patients directly to a multicentre randomized controlled trial are discussed. In Study 2, the method used to compile a sampling frame for a national questionnaire survey following the eight principles of the Act are described. FINDINGS: Our experience has shown that health care professionals are increasingly required to recruit patients to intervention trials, and that researchers are not allowed access to the names of patients or other subjects to ask them for consent to participate in a study. The requirement for researchers to use "intermediaries" to obtain consent from and recruit subjects to studies increases the risk of selection bias, may expose the practitioner to ethical difficulties and may compromise the external validity of trial results. There is also a danger that research costs will soar when the Data Protection Act (1998) is fully realized. CONCLUSION: The Data Protection Act (1998) is currently being interpreted in a number of different ways. We conclude there is an urgent need for consensus within the health service and academic communities.

Qualitative study of pilot payment aimed at increasing general practitioners' antismoking advice to smokers.

OBJECTIVES: To elicit general practitioners' and practice nurses' accounts of changes in their clinical practice or practice organisation made to claim a pilot health promotion payment. To describe attitudes towards the piloted and previous health promotion payments. DESIGN: Qualitative, semistructured interview study. SETTING: 13 general practices in Leicester. PARTICIPANTS: 18 general practitioners and 13 practice nurses. RESULTS: Health professionals did not report substantially changing their clinical practice to claim the new payments and made only minimal changes in practice organisation. The new health promotion payment did not overcome general practitioners' resistance towards raising the issue of smoking when they felt that doing so could cause confrontation with patients. General practitioners who made the largest number of claims altered the way in which they recorded patients' smoking status rather than raising the topic of smoking more frequently with patients. PARTICIPANTS had strong negative views on the new payment, feeling it would also be viewed negatively by patients. They were, however, more positive about health promotion payments that rewarded "extra" effort-for example, setting up practice based smoking cessation clinics. CONCLUSIONS: General practitioners and practice nurses were negative about a new health promotion payment, despite agreeing to pilot it. Health promotion payments do not automatically generate effective health promotion activity, and policymakers should consider careful piloting and evaluation of future changes in health promotion payments.

The management of venous leg ulcers: a project to improve care.

This article describes a two-year project to develop resources for the improvement of leg ulcer management. It was felt that an audit tool and complementary resources, such as a resource pack and implementation guide, could help practitioners to implement clinical guidelines on leg ulcer management in practice. The audit results from the pilot project are briefly described and discussed in terms of informing future work.

An evaluation of a local clinical supervision scheme for practice nurses.

This paper presents the findings of an evaluation of a local clinical supervision scheme for practice nurses in Leicestershire, UK. A baseline and a follow-up postal questionnaire were sent to all practice nurses (including supervisors) and general practice senior partners to find out how far the objectives of the local scheme had been met during the first year of implementation. Two focus groups gathered qualitative data about the process of implementation. Twelve months after implementation 12% of practice nurses and over two thirds of GPs reported that they were unaware of the scheme. Forty-three percent of practice nurses did not know who their local supervisor was; most reported that they would like to have known. Eighteen percent of practice nurses reported uptake of supervision through the local scheme. The benefits of involvement were professional development tailored to individual learning needs and regular opportunities to share work-related problems with peers; about a third reported benefits for the practice as well. The existing availability of peer support and time needed to undertake clinical supervision were common reasons given for non-involvement in the scheme. Misconceptions about the purpose of clinical supervision presented further obstacles. At follow-up over half of the practice nurses remained undecided about their future involvement in the scheme. If the benefits associated with clinical supervision are to be realized, the obstacles that currrently hinder practice nurses' involvement need addressing.

Epidemiology and classification of urinary incontinence.

Urinary incontinence is a common symptom affecting the physical, psychological, social and economic well-being of individuals and their families. It also poses a considerable economic burden on health and social services. The literature reports widely varying prevalence rates for incontinence that are partially explained by methodological differences between studies. However, community-based studies indicate that approximately 6% of the population, particularly women and older people, will have urinary incontinence of sufficient severity to interfere with their quality of life. This represents a significant demand for health care. Although further research on prevalence is unlikely to add anything new to current knowledge on the size of the problem, more information is needed on the onset, progression and risk factors of urinary incontinence to inform methods of effective treatment and preventive strategies. In addition, there has been little investigation of the triggers to seeking professional help or of the response of health professionals to patients' demands for treatment, either for incontinence or other lower urinary tract symptoms. The aetiology of incontinence is multifactorial; incontinence is caused by pathophysiological impairments to the lower urinary tract and neurological system, as well as a range of external factors. The key to effective management, therefore, is a comprehensive assessment of the patient, including other lower urinary tract symptoms, so that appropriate intervention is tailored on a diagnosis and not on symptoms.

Factors influencing discussion of smoking between general practitioners and patients who smoke: a qualitative study.

BACKGROUND: Anti-smoking advice from general practitioners (GPs) is effective and recent evidence-based guidelines urge GPs to advise all patients against smoking at every opportunity. GPs do not exploit many opportunities to discuss smoking with patients and the reasons for this are unclear. AIM: To elicit, relate, and interpret GPs' accounts of why they discuss smoking with some patients and not others. METHOD: Thirty-nine Leicestershire GPs were purposively selected so as to have a range of attitudes towards discussing smoking with patients. Each GP had one surgery session video-recorded and afterwards participated in a qualitative, semi-structured interview. Prior to each interview, GPs were shown a video-recording of one of their consultations with a smoker to enhance their recall of events. RESULTS: Being aware of patients' smoking status did not necessarily result in GPs discussing smoking with patients. GPs were keen to preserve good doctor-patient relationships and avoid negative responses from patients once the topic of smoking had been raised, and this was felt to be best achieved by restricting most discussions about smoking to situations where patients presented with smoking-related problems and in circumstances where the doctors perceived the doctor-patient relationship was strong. Doctors also thought it important to address patients' agendas relating to the current consultation before discussing smoking. CONCLUSIONS: General practitioners have strong reasons for preferring to discuss smoking when patients present with smoking-related problems. Those wishing to increase the amount of advice-giving by GPs might be more successful if they encouraged GPs to make greater use of problem-orientated opportunities to discuss smoking.

Left in limbo: patients' views on care across the primary/secondary interface.

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.

Evidence for nursing practice: a clarification of the issues.

There has been considerable confusion and unease within the nursing profession about the emphatic push for all healthcare to be 'evidence-based'. In particular, there has been anxiety that the emphasis on evidence ignores practitioners' skills and individual patient preferences. This paper attempts to clarify the main issues surrounding evidence-based nursing. These include its epidemiological origins and purpose, the meaning and limits of 'evidence', the need for individual skills and expertise in the use of evidence, and the strengths and weaknesses of different kinds of evidence. It aims to debunk the misconception that randomized controlled trials are synonymous with evidence, and to increase critical awareness of the nature of evidence in nursing.

Measuring patients' attitudes to care across the primary/secondary interface: the development of the patient career diary.

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.