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OBJECTIVE: To evaluate, among medical students learning the female pelvic examination, the added benefits of training by gynaecological teaching associates compared with training involving a manikin only. DESIGN: Randomised controlled trial. SETTING: Nine university teaching hospitals. POPULATION: Ninety-four medical students recruited prior to commencing a 4-week obstetrics and gynaecology rotation. METHODS: The control training consisted of lectures, demonstration of the pelvic examination on a manikin, and opportunities to practise on this low-fidelity simulation (n = 40). The experimental group received additional gynaecological teaching associate training, delivered by pairs of experienced associates to groups of four medical students (n = 54). MAIN OUTCOME MEASURES: Outcomes measured at the end of the rotation included knowledge of the correct order of examination components (Yes/No), and student comfort [Likert scales anchored between 1 (very uncomfortable) and 4 (very comfortable) on four items] and confidence [Likert scales anchored between 1 (No) and 3 (Yes) on six items]. The primary outcome, measured at the end of the academic year, was the objective structured clinical examination of a female pelvis (score range 0-54). RESULTS: At baseline, the groups were similar in age, gender, and ethnicity. At the end of the clinical rotation, when compared with the control intervention, the experimental intervention had a moderate effect on student knowledge [difference 29.9% (95% CI 11.2-48.6%); P = 0.002] and confidence [difference 1 (95% CI 0-2); P < 0.001], and a large effect on student comfort [difference 1.8 (95% CI 0.6-3.0); P = 0.004]. At the end of the academic year, the experimental intervention had no impact on skills compared with the control [difference 2 (95% CI-1 to 4); P = 0.26]. CONCLUSIONS: Among medical students taught the female pelvic examination by low-fidelity simulation, additional training by gynaecology teaching associates improved knowledge, comfort, and confidence at the end of the clinical rotation but did not improve examination skills at end of the academic year.

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BACKGROUND: Evidence shows that patients with cancer have many information needs, but specific requirements of patients undergoing surgery for oesophago-gastric (OG) cancer have not been well explored. This study surveyed information needs of patients with OG cancer and explored associations between patient characteristics and information needs. PATIENTS: A validated questionnaire assessing the importance of information about i) the nature, process and prognosis of the cancer, ii) tests, iii) treatments, and iv) physical and psychosocial outcomes (quality of life information) was completed by patients before and after OG cancer treatment. Items responses were transformed to a 0-100 score and linear regression explored associations between clinical and socio-demographic patient characteristics and patient information needs. RESULTS: Questionnaires from 136 respondents were received (response rate 60%, 25% pre-operative, 77% men, mean age 66). Most types of information were rated as important, with information about prognosis and quality of life issues being scored as highly important by over 112 (82%) patients. Linear regression showed that women rated information relating to treatment and psychosocial effects as more important than men (p < 0.038), but no other associations were identified. CONCLUSIONS: Most patients with OG cancer want detailed information, especially information about prognosis and quality of life. It is recommended that surgeons provide this for patients alongside information that the surgeon considers important.

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BACKGROUND: Patients often do not get the information they require from doctors and nurses. To address this problem, interventions directed at patients to help them gather information in their healthcare consultations have been proposed and tested. OBJECTIVES: To assess the effects on patients, clinicians and the healthcare system of interventions which are delivered before consultations, and which have been designed to help patients (and/or their representatives) address their information needs within consultations. SEARCH STRATEGY: We searched: the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library (issue 3 2006); MEDLINE (1966 to September 2006); EMBASE (1980 to September 2006); PsycINFO (1985 to September 2006); and other databases, with no language restriction. We also searched reference lists of articles and related reviews, and handsearched Patient Education and Counseling (1986 to September 2006). SELECTION CRITERIA: Randomised controlled trials of interventions before consultations designed to encourage question asking and information gathering by the patient. DATA COLLECTION AND ANALYSIS: Two researchers assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of five outcomes. MAIN RESULTS: We identified 33 randomised controlled trials, from 6 countries and in a range of settings. A total of 8244 patients was randomised and entered into studies. The most common interventions were question checklists and patient coaching. Most interventions were delivered immediately before the consultations.Commonly-occurring outcomes were: question asking, patient participation, patient anxiety, knowledge, satisfaction and consultation length. A minority of studies showed positive effects for these outcomes. Meta-analyses, however, showed small and statistically significant increases for question asking (standardised mean difference (SMD) 0.27 (95% confidence interval (CI) 0.19 to 0.36)) and patient satisfaction (SMD 0.09 (95% CI 0.03 to 0.16)). There was a notable but not statistically significant decrease in patient anxiety before consultations (weighted mean difference (WMD) -1.56 (95% CI -7.10 to 3.97)). There were small and not statistically significant changes in patient anxiety after consultations (reduced) (SMD -0.08 (95%CI -0.22 to 0.06)), patient knowledge (reduced) (SMD -0.34 (95% CI -0.94 to 0.25)), and consultation length (increased) (SMD 0.10 (95% CI -0.05 to 0.25)). Further analyses showed that both coaching and written materials produced similar effects on question asking but that coaching produced a smaller increase in consultation length and a larger increase in patient satisfaction. Interventions immediately before consultations led to a small and statistically significant increase in consultation length, whereas those implemented some time before the consultation had no effect. Both interventions immediately before the consultation and those some time before it led to small increases in patient satisfaction, but this was only statistically significant for those immediately before the consultation. There appear to be no clear benefits from clinician training in addition to patient interventions, although the evidence is limited. AUTHORS' CONCLUSIONS: Interventions before consultations designed to help patients address their information needs within consultations produce limited benefits to patients. Further research could explore whether the quality of questions is increased, whether anxiety before consultations is reduced, the effects on other outcomes and the impact of training and the timing of interventions. More studies need to consider the timing of interventions and possibly the type of training provided to clinicians.

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BACKGROUND: Shared decision-making (SDM) between professionals and patients is increasingly advocated from ethical principles. Some data are accruing about the effects of such approaches on health or other patient-based outcomes. These effects often vary substantially between studies. OBJECTIVE: Our aim was to evaluate the effects of training GPs in SDM, and the use of simple risk communication aids in general practice, on patient-based outcomes. METHODS: A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. After baseline, participating doctors were randomized to receive training in (i) SDM skills; or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were randomly allocated to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations took place in 'research clinics' to evaluate the effects of more time for consultations, compared with usual surgery time. Patient-based outcomes were assessed at exit from consultation and 1 month follow-up. These were: COMRADE instrument (principal measures; subscales of risk communication and confidence in decision), and a range of secondary measures (anxiety, patient enablement, intention to adhere to chosen treatment, satisfaction with decision, support in decision making and SF-12 health status measure). Multilevel modelling was carried out with outcome score as the dependent variable, and follow-up point (i.e. exit or 1 month later for each patient), patient and doctor levels of explanatory variables. RESULTS: No statistically significant changes in patient-based outcomes due to the training interventions were found: COMRADE risk communication score increased 0.7 [95% confidence interval (CI) -0.92 to 2.32] after risk communication training and 0.9 (95% CI -0.89 to 2.35) after SDM training; and COMRADE satisfaction with communication score increased by 1.0 (95% CI -1.1 to 3.1) after risk communication, and decreased by 0.6 (95% CI 2.7 to -1.5) after SDM training. Patients' confidence in the decision (2.1 increase, 95% CI 0.7-3.5, P < 0.01) and expectation to adhere to chosen treatments (0.7 increase, 95% CI 0.04-1.36, P < 0.05) were significantly greater among patients seen in the research clinics (when more time was available) compared with usual surgery time. Most outcomes deteriorated between exit and 1 month later. There was no interaction between intervention effects. CONCLUSION: Patients can be more involved in treatment decisions, and risks and benefits of treatment options can be explained in more detail, without adversely affecting patient-based outcomes. SDM and risk communication may be advocated from values and ethical principles even without evidence of health gain or improvement in patient-based outcomes, but the resources required to enhance these professional skills must also be taken into consideration. These data also indicate the benefits of extra consultation time.

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Patient-based outcome measures are increasingly important in health care evaluations, often through the use of paper-based questionnaires. The likely impact of questionnaires upon patients is not often considered and therefore, the balance of benefit and harm not fully explored. Harms that might accrue for research staff are even less frequently considered. This paper describes the use of postal questionnaires within a study of breast disease management in primary care. Questionnaire responses are used to describe the nature of discomfort or harms that may occur in such studies. Ethical issues raised by the harms are discussed in relation to the benefits of the study. Practical suggestions for reducing harm to patients are proposed. A secondary consideration, discomfort to the researcher, is also identified and suggestions made to reduce its effect. Finally, the role of research questionnaires as a study intervention is discussed.

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OBJECTIVES: The aims of this study were to examine how GPs manage the consultation for upper resiratory tract infections (URTIs) and the prescribing of antibiotics, to understand what skills and strategies are used in managing URTIs without antibiotics, and to note evidence of pressure on doctors to prescribe and whether there are signs of overt disagreement about prescribing in the consultation. METHODS: A qualitative analysis of audiotaped consultations was carried out. The setting was a general practice in South Wales and the subjects were five GPs and 29 parents presenting children with URTIs over a 2-week period. The main outcome measures were skills and strategies identified from audiotapes of consultations. RESULTS: This group of GPs used a set of readily identifiable consulting skills for managing the consultation without prescribing. Their consultations had a highly routinized quality. There was little evidence of either conflict or overt pressure from parents to prescribe. The word 'antibiotics' was seldom mentioned. Clinicians did not elicit patient expectations for receiving antibiotics. CONCLUSIONS: Doctors use a set of readily identifiable skills in managing the URTI consultation. Avoiding the prescribing of antibiotics is not necessarily a simple and straightforward matter. Since patients apparently want antibiotics less than anticipated, eliciting expectations might be a way of reducing prescribing and broadening the approach to meeting patient needs. Whether doctors can adjust their routinized consulting patterns in the time-limited context of general practice remains an open question.

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Antibiotics are often prescribed to patients with respiratory tract infections who are unlikely to benefit. Models of physician-patient interaction may help understanding of this problem and inform the design of communication skills interventions to enhance appropriate prescribing. The 'paternalistic model' of the consultation remains common in the setting of acute respiratory tract infections. However, the four assumptions that could support this model are not valid for most of these patients, because: best treatment is controversial; management is inconsistent; physicians are not in the best position to evaluate trade-offs between management options without understanding patients' perspectives; and many pressures (apart from patients' agendas) intrude into the consultation. One alternative is the 'informed model' of consulting, but this does not take society's interests into account. The 'shared decision-making model', however, provides a framework for addressing both clinicians' and patients' agendas, and could guide the development and evaluation of specific consultation strategies to promote more appropriate use of antibiotics in primary care.

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'Benchmarking' clinical practice and integrating such data with national guidelines offers a way of establishing standards for use in clinical governance. We report on a feasibility project for benchmarking clinical practice in one topic area (otitis media) using simulated clinical scenarios. Consistency and variations in clinical management were identified for different scenarios. Participants perceived the process likely to reflect actual practice and effect change in clinical management.

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We wanted to determine whether research instruments exist which focus on measuring to what extent health professionals involve patients in treatment and management decisions. A systematic search and appraisal of the relevant literature was conducted by electronic searching techniques, snowball sampling and correspondence with field specialists. The instruments had to concentrate on assessing patient involvement in decision-making by observation techniques (either direct or using audio or videotaped data) and contain assessments of the core aspects of 'involvement', namely evidence of patients being involved (explicitly or implicitly) in decision-making processes, a portrayal of options and a decision-making or deferring stage. Eight instruments met the inclusion criteria. But we did not find any instruments that had been specifically designed to measure the concept of 'involving patients' in decisions. The results reveal that little attention has been given to a detailed assessment of the processes of patient involvement in decision-making. The existing instrumentation only includes these concepts as sub-units within broader assessments, and does not allow the construct of patient involvement to be measured accurately. Instruments developed to measure 'patient-centeredness' are unable to provide enough focus on 'involvement' because of their attempt to cover so many dimensions. The concept of patient involvement (shared decision-making; informed collaborative choice) is emerging in the literature and requires an accurate method of assessment.

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BACKGROUND: Nurses increasingly manage acute illness in United Kingdom (UK) general practice. Few data exist about patients routinely consulting with these nurses. There are concerns that providing this additional service will lower thresholds for consulting with an overall increase in workload. Upper respiratory tract infection (URTI) is the commonest reason for consulting. Inappropriate antibiotics promote resistant bacteria. Nurse management of URTI is an ideal opportunity to promote self-care and nonantibiotic management. AIMS: To describe the effects of a specially trained practice nurse managing URTI in a general practice in Cardiff, UK. METHODS: Descriptive study. RESULTS: Data were collected on 132 patients consulting with the nurse. We also collected data on 234 patients consulting general practitioners (GPs) in the same practice. Patients seen by the nurse were younger and less likely to be given antibiotics at the time of their index illness than those who saw GPs (7% vs. 93%; P < 0.001). During the year following the consultation with the nurse, patients consulted slightly less often and received antibiotics for URTI less often compared with the year preceding this consultation (P=0.02). Their consultation rate for all conditions did not change. The consultation rates for URTI of the patients managed by the GPs remained constant and consultations for all conditions increased (P < 0.01). CONCLUSIONS: Nurse management of URTI did not lower patients' threshold for future consulting, and patients who saw her were prescribed antibiotics less often.

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OBJECTIVE: To ascertain any differences between care from nurse practitioners and that from general practitioners for patients seeking "same day" consultations in primary care. DESIGN: Randomised controlled trial with patients allocated by one of two randomisation schemes (by day or within day). SETTING: 10 general practices in south Wales and south west England. SUBJECTS: 1368 patients requesting same day consultations. MAIN OUTCOME MEASURES: Patient satisfaction, resolution of symptoms and concerns, care provided (prescriptions, investigations, referrals, recall, and length of consultation), information provided to patients, and patients' intentions for seeking care in the future. RESULTS: Generally patients consulting nurse practitioners were significantly more satisfied with their care, although for adults this difference was not observed in all practices. For children, the mean difference between general and nurse practitioner in percentage satisfaction score was -4.8 (95% confidence interval -6.8 to -2.8), and for adults the differences ranged from -8.8 (-13.6 to -3.9) to 3.8 (-3.3 to 10.8) across the practices. Resolution of symptoms and concerns did not differ between the two groups (odds ratio 1.2 (95% confidence interval 0.8 to 1.8) for symptoms and 1.03 (0.8 to 1.4) for concerns). The number of prescriptions issued, investigations ordered, referrals to secondary care, and reattendances were similar between the two groups. However, patients managed by nurse practitioners reported receiving significantly more information about their illnesses and, in all but one practice, their consultations were significantly longer. CONCLUSION: This study supports the wider acceptance of the role of nurse practitioners in providing care to patients requesting same day consultations.

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BACKGROUND: Involving patients in healthcare decisions makes a potentially significant and enduring difference to healthcare outcomes. One difficulty (among many) is that the 'involvement' of patients in decisions has been left undefined. It is usually conceptualised as 'patient centredness', which is a broad and variably interpreted concept that is difficult to assess using current tools. This paper attempts to gauge general practitioners' (GPs') attitudes to patient involvement in decision making and their views about the contextual factors, competences, and stages required to achieve shared decisions within consultations. AIM: To explore and understand what constitutes the appropriate involvement of patients in decision making within consultations, to consider previous theory in this field, and to propose a set of competences (skills) and steps that would enable clinical practitioners (generalists) to undertake 'shared decision making' in their clinical environment. METHOD: Qualitative study using focus group interviews of key informants. RESULTS: Experienced GPs with educational roles have positive attitudes to the involvement of patients in decisions, provided the process matches the role individuals wish to play. They perceive some clinical problems as being more suited to a cooperative approach to decision making and conceptualised the existence of professional equipoise towards the existence of legitimate treatment options as an important facilitative factor. A sequence of skills was proposed as follows: 1) implicit or explicit involvement of patients in the decision-making process; 2) explore ideas, fears, and expectations of the problem and possible treatments; 3) portrayal of equipoise and options; 4) identify preferred data format and provide tailor-made information; 5) checking process: understanding of information and reactions (e.g. ideas, fears, and expectations of possible options); 6) acceptance of process and decision making role preference; 7) make, discuss or defer decisions; 8) arrange follow-up. CONCLUSIONS: These clinicians viewed involvement as an implicit ethos that should permeate medical practice, provided that clinicians respect and remain alert to patients' individual preferred roles in decision making. The interpersonal skills and the information requirements needed to successfully share decisions are major challenges to the clinical consultation process in medical practice. The benefits of patient involvement and the skills required to achieve this approach need to be given much higher priority at all levels: at policy, education, and within further professional development strategies.

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The second half of the consultation is where decisions are made and future management agreed. We argue that this part of the clinical interaction has been 'neglected' during a time when communication skill development has been focused on uncovering and matching agendas. There are many factors, such as the increasing access to information and the emphasis on patient autonomy, which have led to the need to give more attention to both the skills and the information required to appropriately involve patients in the decision-making process. This analysis, based on a literature review, considers the concept of 'shared decision-making' and asks whether this approach is practical in the primary care setting. This study, and our ongoing research programme, indicates that future developments in this area depend on increasing the time available within consultations, require improved ways of communicating risk to patients, and an acquisition of new communication skills.

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OBJECTIVES: We aimed to show how in multi-disciplinary research data collected to meet the needs of one discipline can provide information of value to another. METHODS: Using the critical incident technique, 25 GPs were interviewed about recent scans requested for patients with knee and lumbar spine complaints. Transcripts of the interviews were scrutinized from both a medical and an economic perspective. RESULTS: Five key economic issues where further research is needed were identified. CONCLUSIONS: The total value of the information provided by multi-disciplinary research may exceed the sum of the information collected to meet the requirements of the individual disciplines.

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BACKGROUND: Methods are needed to ensure that those patients referred from primary to secondary care are those most likely to benefit. In-house referral is the referral of a patient by a general practitioner to another general practitioner within the same practice for a second opinion on the need for secondary care referral. OBJECTIVE: To describe whether in-house referral is practical and acceptable to patients, and the health outcomes for patients. METHODS: Practices were randomized into an intervention or a control group. In intervention practices, patients with certain conditions who were about to be referred to secondary care were referred in-house. If the second clinician agreed referral was appropriate the patient was referred on to secondary care. In control practices patients were referred in the usual fashion. Patient satisfaction and health status was measured at the time of referral, 6 months and one year. RESULTS: Eight intervention and seven control practices took part. For the 177 patients referred in-house, 109 (61%) were judged to need referral on to secondary care. For patient satisfaction, the only difference between the groups studied was that at 12 months patients who had been referred in-house reported themselves as being more satisfied than those referred directly to hospital. For health status, the only difference found was that at the time of referral, patients who had been referred in-house and judged to need hospital referral reported themselves as being less able on the 'Physical function' subscale of the SF-36 than patients who were referred in-house and judged to not need hospital referral. CONCLUSION: In-house referral is acceptable to patients and provides a straightforward method of addressing uncertainty over the need for referral from primary to secondary care.

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