Conceptual framework and systematic review of the effects of participants' and professionals' preferences in randomised controlled trials.

OBJECTIVES: To develop a conceptual framework of preferences for interventions in the context of randomised controlled trials (RCTs), as well as to examine the extent to which preferences affect recruitment to RCTs and modify the measured outcome in RCTs through a systematic review of RCTs that incorporated participants' and professionals' preferences. Also to make recommendations on the role of participants' and professionals' preferences in the evaluation of health technologies. DATA SOURCES: Electronic databases. REVIEW METHODS: The conceptual review was carried out on published papers in the psychology and economics literature concerning concepts of relevance to patient decision-making and preferences, and their measurement. For the systematic review, studies across all medical specialities meeting strict criteria were selected. Data were then extracted, synthesised and analysed. RESULTS: Key elements for a conceptual framework were found to be that preferences are evaluations of an intervention in terms of its desirability and these preferences relate to expectancies and perceived value of the process and outcome of interventions. RCTs differed in the information provided to patients, the complexity of techniques used to provide that information and the degree to which preference elicitation may simply produce pre-existing preferences or actively construct them. Most current RCTs used written information alone. Preference can be measured in many different ways and most RCTs did not provide quantitative measures of preferences, and those that did tended to use very simple measures. The second part of the study, the systematic review included 34 RCTs. The findings gave support to the hypothesis that preferences affect trial recruitment. However, there was less evidence that external validity was seriously compromised. There was some evidence that preferences influenced outcome in a proportion of trials. However, evidence for preference effects was weaker in large trials and after accounting for baseline differences. Preference effects were also inconsistent in direction. There was no evidence that preferences influenced attrition. Therefore, the available evidence does not support the operation of a consistent and important 'preference effect'. Interventions cannot be categorised consistently on degree of participation. Examining differential preference effects based on unreliable categories ran the risk of drawing incorrect conclusions, so this was not carried out. CONCLUSIONS: Although patients and physicians often have intervention preferences, our review gives less support to the hypothesis that preferences significantly compromise the internal and external validity of trials. This review adds to the growing evidence that when preferences based on informed expectations or strong ethical objections to an RCT exist, observational methods are a valuable alternative. All RCTs in which participants and/or professionals cannot be masked to treatment arms should attempt to estimate participants' preferences. In this way, the amount of evidence available to answer questions about the effect of treatment preferences within and outwith RCTs could be increased. Furthermore, RCTs should routinely attempt to report the proportion of eligible patients who refused to take part because of their preferences for treatment. The findings also indicate a number of approaches to the design, conduct and analysis of RCTs that take account of participants' and/or professionals' preferences. This is referred to as a methodological tool kit for undertaking RCTs that incorporate some consideration of patients' or professionals' preferences. Future research into the amount and source of information available to patients about interventions in RCTs could be considered, with special emphasis on the relationship between sources inside and outside the RCT context. Qualitative research undertaken as part of ongoing RCTs might be especially useful. The processes by which this information leads to preferences in order to develop or extend the proposed expectancy--value framework could also be examined. Other areas for consideration include: how information about interventions changes participants' preferences; a comparison of the feasibility and effectiveness of different informed consent procedures; how strength of preference varies for different interventions within the same RCT and how these differences can be taken account of in the analysis; the differential effects of patients' and professionals' preferences on evidence arising from RCTs; and whether the standardised measurement of preferences within all RCTs (and analysis of the effect on outcome) would allow the rapid development of a significant evidence base concerning patient preferences, albeit in relation to a single preference design.

Substitution of doctors by nurses in primary care.

BACKGROUND: Demand for primary care services has increased in developed countries due to population ageing, rising patient expectations, and reforms that shift care from hospitals to the community. At the same time, the supply of physicians is constrained and there is increasing pressure to contain costs. Shifting care from physicians to nurses is one possible response to these challenges. The expectation is that nurse-doctor substitution will reduce cost and physician workload while maintaining quality of care. OBJECTIVES: Our aim was to evaluate the impact of doctor-nurse substitution in primary care on patient outcomes, process of care, and resource utilisation including cost. Patient outcomes included: morbidity; mortality; satisfaction; compliance; and preference. Process of care outcomes included: practitioner adherence to clinical guidelines; standards or quality of care; and practitioner health care activity (e.g. provision of advice). Resource utilisation was assessed by: frequency and length of consultations; return visits; prescriptions; tests and investigations; referral to other services; and direct or indirect costs. SEARCH STRATEGY: The following databases were searched for the period 1966 to 2002: Medline; Cinahl; Bids, Embase; Social Science Citation Index; British Nursing Index; HMIC; EPOC Register; and Cochrane Controlled Trial Register. Search terms specified the setting (primary care), professional (nurse), study design (randomised controlled trial, controlled before-and-after-study, interrupted time series), and subject (e.g. skill mix). SELECTION CRITERIA: Studies were included if nurses were compared to doctors providing a similar primary health care service (excluding accident and emergency services). Primary care doctors included: general practitioners, family physicians, paediatricians, general internists or geriatricians. Primary care nurses included: practice nurses, nurse practitioners, clinical nurse specialists, or advanced practice nurses. DATA COLLECTION AND ANALYSIS: Study selection and data extraction was conducted independently by two reviewers with differences resolved through discussion. Meta-analysis was applied to outcomes for which there was adequate reporting of intervention effects from at least three randomised controlled trials. Semi-quantitative methods were used to synthesize other outcomes. MAIN RESULTS: 4253 articles were screened of which 25 articles, relating to 16 studies, met our inclusion criteria. In seven studies the nurse assumed responsibility for first contact and ongoing care for all presenting patients. The outcomes investigated varied across studies so limiting the opportunity for data synthesis. In general, no appreciable differences were found between doctors and nurses in health outcomes for patients, process of care, resource utilisation or cost. In five studies the nurse assumed responsibility for first contact care for patients wanting urgent consultations during office hours or out-of-hours. Patient health outcomes were similar for nurses and doctors but patient satisfaction was higher with nurse-led care. Nurses tended to provide longer consultations, give more information to patients and recall patients more frequently than did doctors. The impact on physician workload and direct cost of care was variable. In four studies the nurse took responsibility for the ongoing management of patients with particular chronic conditions. The outcomes investigated varied across studies so limiting the opportunity for data synthesis. In general, no appreciable differences were found between doctors and nurses in health outcomes for patients, process of care, resource utilisation or cost. AUTHORS' CONCLUSIONS: The findings suggest that appropriately trained nurses can produce as high quality care as primary care doctors and achieve as good health outcomes for patients. However, this conclusion should be viewed with caution given that only one study was powered to assess equivalence of care, many studies had methodological limitations, and patient follow-up was generally 12 months or less. While doctor-nurse substitution has the potential to reduce doctors' workload and direct healthcare costs, achieving such reductions depends on the particular context of care. Doctors' workload may remain unchanged either because nurses are deployed to meet previously unmet patient need or because nurses generate demand for care where previously there was none. Savings in cost depend on the magnitude of the salary differential between doctors and nurses, and may be offset by the lower productivity of nurses compared to doctors.

A subtle governance: 'soft' medical leadership in English primary care.

In many countries governments are recruiting the medical profession into a more active, transparent regulation of clinical practice. Consequently the medical profession adapts the ways it regulates itself and its relationship to health system managers changes. This paper uses empirical research in English Primary Care Groups (PCGs) and Primary Care Trusts (PCTs) to assess the value of Courpasson's concept of soft bureaucracy as a conceptualisation of these changes. Clinical governance in PCGs and PCTs displays important parallels with governance in soft bureaucracies, but the concept of soft bureaucracy requires modification to make it more applicable to general practice. In English primary care, governance over rank-and-file doctors is exercised by local professional leaders rather than general managers, harnessing their colleagues' perception of threats to professional autonomy and self-regulation rather than fears of competition as the means of 'soft coercion'.

Team structure, team climate and the quality of care in primary care: an observational study.

OBJECTIVES: To determine whether practice structure (for example, list size, number of staff) predicts team processes and whether practice structure and team process in turn predict team outcomes DESIGN: Observational study using postal questionnaires and medical note audit. Team process was assessed through a measure of "climate" which examines shared perceptions of organisational policies, practices, and procedures. SETTING: Primary care. SUBJECTS: Members of the primary health care team from 42 practices. MAIN OUTCOME MEASURES: Objective measures of quality of chronic disease management, patients' evaluations of practices, teams' self-reported ratings of effectiveness, and innovation. RESULTS: Team climate was better in singlehanded practices than in partnerships. Practices with longer booking intervals provided superior chronic disease management. Higher team climate scores were associated with superior clinical care in diabetes, more positive patient evaluations of practice and self-reported innovation and effectiveness. CONCLUSIONS: Although the conclusions are preliminary because of the limited sample size, the study suggests that there are important relationships between team structure, process, and outcome that may be of relevance to quality improvement initiatives in primary care. Possible causal mechanisms that might underlie these associations remain to be determined.

Patient-practitioner agreement: does it matter?

BACKGROUND: Good communication is a crucial clinical skill. Previous research demonstrated better clinical outcomes when practitioners and patients agree about the nature of patients' core presenting complaints. We investigated the nature of this agreement and its impact on outcome among depressed primary care patients. METHOD: We compared presenting problem formulations completed by patients, GPs and therapists in a primary care randomized controlled trial of cognitive-behavioural therapy and non-directive counselling for depression. Participants compiled formulations from a list of 13 potential problems of self-completed questionnaires. Subjects scored at least 14 on the Beck Depression Inventory (BDI) at baseline. Outcome measure for this study included BDI at 4 and 12 months, failure to attend for therapy when referred, dropout from therapy and patient satisfaction. RESULTS: Among 464 trial patients, 395 received therapy. Patient baseline problem formulations included significantly more items than GPs, who identified significantly more items than therapists. Agreement levels varied according to a range of patient and professional variables. While patients in complete agreement with their therapists about their main problem after assessment had lower average BDI scores at 12 months (9.7 v. 12.8, P=0.03); we found no other significant associations between the extent of agreement and clinical outcome. There were significant (but relatively weak) associations between agreement and aspects of patient satisfaction. CONCLUSION: Our results suggest that detailed mutual understanding of the presenting complaints may be less important than agreement that the core problem is psychological, and that referral for psychological therapy is appropriate.

Job satisfaction, work-related stress and intentions to quit of Scottish GPS.

UNLABELLED: Job satisfaction and work-related stress influence physician retention, turnover, and patient satisfaction. This study purports to elicit the views of Scottish GPs on job satisfaction, stress, intentions to quit, and to examine any patterns by demographic, job, and practice characteristics. A descriptive, cross-sectional study was undertaken by postal questionnaire on a random sample of 1,000 GP principals, 359 GP non-principals, and 62 PMS GPs. The response rate was 56%. GPs were most satisfied with their colleagues, variety in the job, and amount of responsibility given. The most frequently mentioned sources of job stress were increasing workloads, paperwork, insufficient time to do justice to the job, increased and inappropriate demands from patients. White, female, young (under 40 years) and old (55 years and over) GP non-principals and PMS GPs who work less than 50 hours per week as a GP were more likely to be satisfied with their job and reported lower levels of stress. CONCLUSIONS: GP participation in the workforce could be promoted by introducing more flexible working patterns (e.g. part-time work), by expanding the scope of contractual arrangements, and by making patient expectations more realistic by clearly communicating what the role of a GP actually encompasses.

Solving inequities in provider distribution: loan repayment.

The distribution of primary health care professionals in England and Wales is inequitable, with relatively lower concentrations of professionals in deprived areas. The objective of the present study was to determine whether graduate health professionals would be willing to work in under-served areas in return for educational loan repayment. The study group consisted of a convenience sample of 50 newly qualified and trainee general practitioners, and 50 newly qualified community nurses and health visitors in mid- and west Wales. At interview, the subjects were presented with descriptions of general practices and asked to indicate their preferred practice. Practice descriptions varied systematically in terms of location (i.e. urban, suburban and rural), population deprivation (i.e. deprived or mixed affluent/deprived) and availability of loan repayment (i.e. none or loans paid off over a period of between one and 4 years). The main outcome was the probability that a practice with loan repayment was chosen. Compared with a suburban practice, a one-year loan repayment option made the rural and urban deprived practices 1.6 times and 1.2 times more likely to be chosen, respectively. Nurses were generally more willing than doctors to work in a deprived area in return for loan repayment. The findings suggest that loan repayment may offset health professionals' aversion to working in deprived areas. Such a scheme needs to be piloted to see whether it does offer value for money in recruiting health professionals to under-served areas.

Implementing clinical governance in English primary care groups/trusts: reconciling quality improvement and quality assurance.

OBJECTIVES: To investigate the concept of clinical governance being advocated by primary care groups/trusts (PCG/Ts), approaches being used to implement clinical governance, and potential barriers to its successful implementation in primary care. DESIGN: Qualitative case studies using semi-structured interviews and documentation review. SETTING: Twelve purposively sampled PCG/Ts in England. PARTICIPANTS: Fifty senior staff including chief executives, clinical governance leads, mental health leads, and lay board members. MAIN OUTCOME MEASURES: Participants' perceptions of the role of clinical governance in PCG/Ts. RESULTS: PCG/Ts recognise that the successful implementation of clinical governance in general practice will require cultural as well as organisational changes, and the support of practices. They are focusing their energies on supporting practices and getting them involved in quality improvement activities. These activities include, but move beyond, conventional approaches to quality assessment (audit, incentives) to incorporate approaches which emphasise corporate and shared learning. PCG/Ts are also engaged in setting up systems for monitoring quality and for dealing with poor performance. Barriers include structural barriers (weak contractual levers to influence general practices), resource barriers (perceived lack of staff or money), and cultural barriers (suspicion by practice staff or problems overcoming the perceived blame culture associated with quality assessment). CONCLUSION: PCG/Ts are focusing on setting up systems for implementing clinical governance which seek to emphasise developmental and supportive approaches which will engage health professionals. Progress is intentionally incremental but formidable challenges lie ahead, not least reconciling the dual role of supporting practices while monitoring (and dealing with poor) performance.

Completeness and accuracy of the birth registry data on congenital anomalies in Alberta, Canada.

Vital statistics and other administrative data are becoming an increasingly important source for epidemiologic research and surveillance. This study, the first in Canada, evaluated the usefulness of birth registry data on congenital anomalies in Alberta. We compared the number of birth defects recorded in the birth registry with the number collected through the Alberta Congenital Anomalies Surveillance System (ACASS) between 1985 and 1996. In addition, records of 3,881 (99.9 %) babies with (a) birth defect(s) from the ACASS during 1994--1996 were matched to the birth registry by deterministic linkage. Of these, 2,969 babies had single anomalies that were used for validity analysis. The anomalies were grouped by those within International Classification of Disease (ICD) ICD-9 Section XIV (ICD-9=740.0-759.9) and those outside the Section XIV. For those within Section XIV, 24 summary diagnostic categories were examined. As shown, the total case count from the birth registry was on average about 3 % lower than that from the ACASS between 1985 and 1996. The validity of diagnostic categories is high for the 24 categories examined, with an overall agreement of between 80 % and 100 %. The sensitivity, positive predictive value, and kappa are also high for all these anomalies combined during 1994 and 1996, showing 95.7 %, 99.8, and 0.81 respectively.

The treatment of child and adolescent mental health problems in primary care: a systematic review.

BACKGROUND: There is significant potential to increase the accessibility and effectiveness of child and adolescent mental health services through the involvement of primary care professionals and the delivery of interventions in the primary care setting. However, little is known about the actual clinical and cost-effectiveness of such service delivery. OBJECTIVE: The aim of the study was to review systematically the evidence concerning the effectiveness of interventions for child and adolescent mental health problems in primary care, and interventions designed to improve the skills of primary care staff. METHODS: Searches were made of The Cochrane Clinical Trials Register, MEDLINE, PSYCINFO, EMBASE and CINAHL, together with correspondence with subject experts and authors of studies, and checking of references in identified papers. RESULTS AND CONCLUSIONS: There was some preliminary evidence that treatments by specialist staff working in primary care were effective, although the quality of included studies was variable and no data were available on the cost-effectiveness of interventions. Equally, some educational interventions show potential for increasing the skills and confidence of primary care staff, but controlled evaluations were rare and few studies reported actual changes in professional behaviour or patient health outcomes. A significant programme of research is required if the potential for child and adolescent mental health services in primary care is to be realized in an effective and efficient way.