Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study).

BACKGROUND: Trials involving adults who lack capacity to provide consent rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measures limits evaluation of these interventions. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation. METHODS: We used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020. RESULTS: A total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items from the scoping review (n = 36) and additional items proposed by participants (n = 1). Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group (n = 2). We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting. CONCLUSIONS: The study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. These relate to the process of decision-making, proxies' experience of decision-making, and factors that influence decision-making such as understanding. Further work with people with impairing conditions and their families is needed to explore their views about the COS and to identify appropriate outcome measures and timing of measurement. TRIAL REGISTRATION: The study is registered on the COMET database ( https://www.comet-initiative.org/Studies/Details/1409 ).

Patient-reported outcome measures (PROMs) use in post-stroke patient care and clinical practice: a realist synthesis protocol.

BACKGROUND: There is growing interest in the use of routine patient-reported outcome measures (PROMs) to influence the care of individual patients with stroke. However, there are significant gaps in our understanding as to how PROMs influence post-stroke patient care and clinical practice. This is due to factors including the number of purported uses for PROMs and that PROMs are complex interventions, which attempt to stimulate varied actions or behaviours. Therefore, the objective of this realist synthesis is to offer theory-based explanations as to how PROMs influence post-stroke clinical practice and patient care. METHODS: This is a protocol for a realist synthesis, which involves three distinct phases: theory building (phase 1), theory testing and refinement (phase 2) and synthesis (phase 3). Phase 1 will develop initial rough programme theories (IRPTs), through literature searches (from January 2000 onwards) of MEDLINE, EMBASE, PsycINFO, CINAHL, Cochrane Library and the grey literature. Only secondary sources will be included that contribute to the development of IRPTs. Only two IRPTs, prioritised by the stakeholder group, will be taken forward to be tested and refined during phase 2. Further novel searches will be employed in phase 2, utilising the same criteria as phase 1; however, phase 2 searches will not utilise grey literature searches, and only primary research studies that contribute to the refinement of programme theories under investigation will be included. Two independent reviewers will screen and select all returned results. The reviewers will code and annotate relevant sources, resulting in 'fragments' to be extracted and graded based on the richness of their contribution to explanation and causal insight. Further, these fragments will be organised into 'Context-Mechanism-Outcome' configurations. Phase 3 of the review will involve the synthesis of context-mechanism-outcome configurations to form middle-range theory-based explanations and developed logic models for stakeholders to understand how PROMs in post-stroke clinical practice and patient care work for whom, how and under what circumstances. DISCUSSION: The resulting realist synthesis will provide guidance on the implementation of PROMs within routine post-stroke clinical practice and patient care and act as a touchstone for further testing and refinement of PROMs programmes. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020138649 .

Evaluation of the effectiveness of the Family Nurse Partnership home visiting programme in first time young mothers in Scotland: a protocol for a natural experiment.

INTRODUCTION: Individual, social and economic circumstances faced by young mothers (19 years or under) can challenge a successful start in life for their children. Intervening early might enhance life chances for both mother and child. The Family Nurse Partnership (FNP) is an intensive nurse-led home visiting programme developed in the US which aims to improve prenatal health behaviours, birth outcomes, child development and health outcomes, and maternal life course. Establishing evidence of effectiveness beyond the original US setting is important to understand where further adaptation is required within a country specific context. OBJECTIVE: This study will form one strand of the Scottish Government's plan to evaluate the effectiveness of FNP as compared to usual care for mothers and their children in Scotland and will focus only on outcomes that can be identified using routine administrative data systems. METHODS: This study is a natural experiment with a case-cohort design using linked anonymised routine health, educational and social care data. Cases will be women enrolled as FNP Clients in ten NHS Health Boards in Scotland and Controls will be women who met FNP eligibility criteria but were pregnant at a time when the programme was not recruiting. Outcomes are mapped to the Scottish FNP logic model. All comparative analyses will be pre-specified, conducted on an intention to treat basis and will use multilevel regression models to compare outcomes between groups. DISCUSSION: The study protocol is based upon the specification of FNP commissioned by the Scottish Government. This study design is novel for the evaluation of the FNP/NFP programmes which are primarily evaluated with an RCT. Outcomes included within the study have been selected on the basis that they are outcomes FNP aims to influence and where there is routine data available to assess the outcome.

Doctors' decisions when disclosing their mental ill-health.

BACKGROUND: Understanding of what prevents doctors from seeking help for mental ill-health has improved. However, less is known about what promotes timely disclosure and the nature of doctors' decision making. AIMS: This study aimed to define how doctors make decisions about their own mental ill-health, and what facilitates disclosure. It explored the disclosure experiences of doctors and medical students; their attitudes to their decisions, and how they evaluate potential outcomes. METHODS: Qualitative, semi-structured interviews with UK doctors and medical students with personal experience of mental ill-health. Participants were recruited through relevant organizations, utilizing regular communications such as newsletters, e-mails and social media. Data were subject to a thematic analysis. RESULTS: Forty-six interviews were conducted. All participants had disclosed their mental ill-health to someone; not all to their workplace. Decision making was complex, with many participants facing multiple decisions throughout their careers. Disclosures were made despite the many obstacles identified in the literature; participants described enablers to and benefits of disclosing. The importance of appropriate responses to first disclosures was highlighted. CONCLUSIONS: Motivations to disclose mental ill-health are complex and multifactorial. An obstacle for one was an enabler for another. Understanding this and the importance of the first disclosure has important implications for how best to support doctors and medical students in need.

Establishing the feasibility of a community and primary health care intervention to raise awareness of symptoms of Type 1 Diabetes-The Early Detection of Type 1 Diabetes in Youth (EDDY) study.

AIMS: To design, develop, and evaluate the feasibility of delivering a multi-component community based intervention to parents and primary health care professionals to raise awareness of the symptoms of Type 1 diabetes (T1D) in childhood in 3 adjoining borough counties of South Wales. MATERIALS AND METHODS: Parent and primary health care advisory groups were established to design the intervention. Qualitative interviews with stakeholders and parents assessed the acceptability, feasibility and any potential impact of the intervention. RESULTS: The parent component of the intervention developed was a re-useable shopping bag with the 4 main symptoms of T1D illustrated on the side, based on the road traffic system of red warning triangles and an octagon "stop" sign stating "Seek Medical Help". Accompanying the bag was an A5 leaflet giving further information. Both were overwrapped with clear plastic and delivered to 98% (323/329) schools, equating to 101 371 children. The primary health care professional component was a dual glucose/ketone meter, single use lancets, stickers, the A5 parent leaflet displayed as a poster and an educational visit from a Community Diabetes Liaison Nurse. 87% (73/84) of GP practices received the intervention, 100% received the materials. The intervention was delivered within Cardiff, the Vale of Glamorgan and Bridgend. Qualitative analyses suggest that the intervention raised awareness and had some impact. CONCLUSION: This study showed that it is feasible and acceptable to design, develop and deliver a community based intervention to raise awareness of T1D. There is some suggestion of impact but a definitive evaluation of effectiveness is still required.

Quality of life Evaluation in patients receiving Steroids (the QuESt tool): initial development in children and young people with acute lymphoblastic leukaemia.

BACKGROUND: The powerful cytotoxic and immunomodulatory effects of corticosteroids are an important element of the success that has been achieved in the treatment of acute lymphoblastic leukaemia (ALL). In addition to physical side effects, corticosteroids can adversely influence behaviour, cognitive function and mood leading to significantly impaired quality of life (QoL). A number of tools exist for assessing QoL, but none of these specifically examines changes attributable to steroids. METHODS: Children and young adults aged 8-24 years and parents of children receiving maintenance therapy for ALL from four UK centres were invited to participate. The study comprised three stages carried out over 2 years: (1) focus groups and interviews where participants were asked to describe their experiences of dexamethasone; (2) analysis of questionnaires sent to healthcare professionals and patients to evaluate the importance and relevance of the questions; and (3) cognitive interviewing. RESULTS: Interpretative phenomenological analysis of focus group and interview transcripts identified that dexamethasone adversely influenced behaviour, appetite, body image, mood and family relationships. 157 electronic survey responses were analysed leading to further item development. Cognitive interviewing confirmed face validity and internal consistency. QuESt comprises 28 questions within four domains and has three age-specific versions. CONCLUSIONS: QuESt is the first treatment-specific QoL measure for children and young adults receiving corticosteroids. It can be completed in 10-15 min by children aged ≥8 years. Further validity and reliability testing will be undertaken. Although the initial application is for ALL, QuESt may also be a valuable tool for understanding the impact of corticosteroids in other paediatric conditions.

Mode of data elicitation, acquisition and response to surveys: a systematic review.

BACKGROUND: Many studies in health sciences research rely on collecting participant-reported outcomes and attention is increasingly being paid to the mode of data collection. Consideration needs to be given to the validity of response via different modes and the impact that choice of mode might have on study conclusions. OBJECTIVES: (1) To provide an overview of the theoretical models of survey response and how they relate to health research; (2) to review all studies comparing two modes of administration for subjective outcomes and assess the impact of mode of administration on response quality; (3) to explore the impact of findings for key identified health-related measures; and (4) to inform the analysis of multimode studies. DATA SOURCES: A broad range of databases (for example EMBASE, PsychINFO, MEDLINE, EconLit, SPORTDiscus, etc.) were chosen to allow as comprehensive a selection as possible, and they were searched up until the end of 2004. REVIEW METHODS: The abstracts were reviewed against inclusion/exclusion criteria. Full papers were retrieved for all selected abstracts and then screened again using more detailed inclusion criteria related to the measures used. Papers that were still included were reviewed in full and detailed data extracted. At each stage, abstracts or papers were reviewed by a single reviewer. RESULTS: The search strategy identified 39,253 unique references, of which 2156 were considered as full papers, with 381 finally included in the review. Two features of mode were clearly associated with bias in response; however, none of the features of mode was associated with changes in precision. How the measure was administered, by an interviewer or by the person themselves, was highly significantly associated with bias (p < 0.001). A difference in sensory stimuli was also significant (p = 0.03). When both of these were present the average overall bias was < 1 point on a percentage scale. In terms of mediating factors, there was some suggestion that there was an interaction between both telephone and computer for data collection and date of publication, supporting the theory that differences disappear as new technologies become commonplace. Single-item measures were also related to greater degrees of bias than multi-item scales (p = 0.01). Individual analysis of the Short Form questionnaire-36 items and Minnesota Multiphasic Personality Inventory (MMPI) showed a varied pattern across the different subscales, with conflicting results between the two types of study. None of the MMPI measures used to detect deviant responding showed a relationship with the mode features tested. The limits of agreement analysis showed how variable measures were between modes at an individual rather than a group mean level. LIMITATIONS: The search strategy covered the period up to 2004, so any new and emerging technologies were not included. Not all potential mode features were tested and there was limited information on potential mediating factors. CONCLUSIONS: Researchers need to be aware of the different mode features that could have an impact on their results when selecting a mode of data collection for subjective outcomes. Further mode comparison studies, which manipulate mode features and directly assess impact over time, would be beneficial.

Development and evaluation by a cluster randomised trial of a psychosocial intervention in children and teenagers experiencing diabetes: the DEPICTED study.

OBJECTIVE: To develop and evaluate a health-care communication training programme to help diabetes health-care professionals (HCPs) counsel their patients more skilfully, particularly in relation to behaviour change. DESIGN: The HCP training was assessed using a pragmatic, cluster randomised controlled trial. The primary and secondary analyses were intention-to-treat comparisons of outcomes using multilevel modelling to allow for cluster (service) and individual effects, and involved two-level linear models. SETTING: Twenty-six UK paediatric diabetes services. PARTICIPANTS: The training was delivered to HCPs (doctors, nurses, dietitians and psychologists) working in paediatric diabetes services and the effectiveness of this training was measured in 693 children aged 4-15 years and families after 1 year (95.3% follow-up). INTERVENTIONS: A blended learning programme was informed by a systematic review of the literature, telephone and questionnaire surveys of professional practice, focus groups with children and parents, experimental consultations and three developmental workshops involving a stakeholder group. The programme focused on agenda-setting, flexible styles of communication (particularly guiding) and a menu of strategies using web-based training and practical workshops. MAIN OUTCOME MEASURES: The primary trial outcome was a change in glycosylated haemoglobin (HbA1c) levels between the start and finish of a 12-month study period. Secondary trial outcomes included change in quality of life, other clinical [including body mass index (BMI)] and psychosocial measures (assessed at participant level as listed above) and cost (assessed at service level). In addition, patient details (HbA1c levels, height, weight, BMI, insulin regimen), health service contacts and patient-borne costs were recorded at each clinic visit, along with details of who patients consulted with, for how long, and whether or not patients consulted on their own at each visit. Patients and carers were also asked to complete an interim questionnaire assessing patient enablement (or feelings towards clinic visit for younger patients aged 7-10 years) at their first clinic visit following the start of the trial. The cost of the intervention included the cost of training intervention teams. RESULTS: Trained staff showed better skills than control subjects in agenda-setting and consultation strategies, which waned from 4 to 12 months. There was no effect on HbA1c levels (p = 0.5). Patients in intervention clinics experienced a loss of confidence in their ability to manage diabetes, whereas controls showed surprisingly reduced barriers (p = 0.03) and improved adherence (p = 0.05). Patients in intervention clinics reported short-term increased ability (p = 0.04) to cope with diabetes. Parents in the intervention arm experienced greater excitement (p = 0.03) about clinic visits and improved continuity of care (p = 0.01) without the adverse effects seen in their offspring. The mean cost of training was £13,145 per site or £2163 per trainee. There was no significant difference in total NHS costs (including training) between groups (p = 0.1). CONCLUSIONS: Diabetes HCPs can be trained to improve consultation skills, but these skills need reinforcing. Over 1 year, no benefits were seen in children, unlike parents, who may be better placed to support their offspring. Further modification of this training is required to improve outcomes that may need to be measured over a longer time to see effects. TRIAL REGISTRATION: Current Controlled Trials ISRCTN61568050. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 15, No. 29. See the HTA programme website for further project information.

The experiences of children and their parents in paediatric diabetes services should inform the development of communication skills for healthcare staff (the DEPICTED Study).

AIMS: The aims of this study were to describe users' experience of paediatric diabetes services to inform development of an intervention to improve communication between staff and patients in secondary care within a wider study (the DEPICTED Study). METHODS: Methods adapted for paediatric settings were used to set up six audio-recorded focus discussion groups with a total of 32 participants. Transcriptions and notes were coded thematically (supported by NVivo software) and analytic themes developed with discussion between researchers. RESULTS: Three main themes developed: the lack of two-way conversation about glycaemic control in clinic settings; the restricting experience of living with diabetes; and the difficult interactions around diabetes the children had with their schools. Doctors in particular were seen as struggling to link these themes of everyday life in their consultations with children and their parents. Children felt marginalized in clinics, despite active involvement in their own blood glucose management at home. CONCLUSIONS: Health professionals need to balance a requirement for good glycaemic control with realism and appreciation of their patients' efforts. There is a need for a systematic approach to consulting, in particular using agenda setting to ensure that the issues of both the patient and the professional are addressed. A framework for a conceptual approach is discussed. How a patient is involved is as important as what is communicated during a consultation.

Meeting the psychosocial needs of children with diabetes within routine clinical practice.

AIMS: There is little guidance for paediatric diabetes teams on how best to meet their patients' psychosocial needs. The aims of conducting this survey of practitioners were to examine the challenges they face in delivering routine care, elicit their approaches to encouraging behaviour change and to inform the development of a training package to be evaluated in the Development and Evaluation of a Psychosocial Intervention with Children and Teenagers Experiencing Diabetes (DEPICTED) Study. METHODS: A semi-structured telephone interview was completed with 44 doctors and seven paediatric diabetes specialist nurses and emergent themes identified. RESULTS: The key challenges for practitioners were categorized as engagement and communication, meeting the needs of different ages and helping patients and their families integrate diabetes into their everyday life. Approaches to behaviour change were described in terms of education, advice and listening. CONCLUSIONS: The survey demonstrates the complexities of communication with such a heterogeneous patient group and the range of approaches taken by practitioners in addressing behaviour change within routine care.

Communication skills of healthcare professionals in paediatric diabetes services.

AIMS: To identify training needs in communication skills and to assess training preferences of staff working in paediatric diabetes services, which will inform the development of a learning programme in behaviour change counselling for healthcare professionals. METHODS: Three hundred and eighty-five staff in 67 UK paediatric diabetes services were sent questionnaires to determine their previous communication skills training, to measure their self-reported view of the importance of and confidence in addressing common clinical problems and to assess the perceived feasibility of training methods to improve skillfulness. RESULTS: Two hundred and sixty-six questionnaires (69%) were returned from 65 services. Sixteen per cent of doctors, nurses and dietitians reported no previous training in communication skills and 47% had received no training since graduating. Respondents rated psychosocial issues as more important to address than medical issues within consultations (t = 8.93, P < 0.001), but felt less confident addressing such issues (t = 15.85, P < 0.001). One-day workshops and monthly team meetings were the most popular of the training options considered (65% and 77%, respectively). CD ROM and web-based learning were considered feasible for 54% and 56% of respondents, respectively, although lack of time (55%) and privacy (34%) were potential barriers. CONCLUSIONS: Addressing psychosocial issues is an important component of consultations involving young people with diabetes, but healthcare professionals find it easier to address medical issues. This represents a key training need in communication skills for diabetes professionals. The survey will inform the development of a tailored learning programme for health professionals in UK paediatric diabetes clinics.

Time to talk? Patient experiences of waiting for clinical management of knee injuries.

BACKGROUND: People with knee problems face long waits for elective surgery in many parts of the world. However, there is little evidence about the impact of delays in such treatment, especially for patients with mechanical knee injuries. OBJECTIVE: To conduct a detailed exploration of patient experiences of waits for specialist diagnosis and surgery for knee injuries at one UK centre. RESEARCH DESIGN: In-depth qualitative paired interviews with a range of patients at baseline and 6 months later. SUBJECTS: Patients awaiting imminent therapeutic arthroscopy of the knee (n = 20) or recently referred from primary care for specialist opinion or imaging for a knee injury (n = 19). Sample stratified to maximise variation by gender and age. RESULTS: 36 patients completed both interviews. Four topic areas were identified. First, problems in the healthcare system were highlighted, including a lack of adequate information, which made it difficult for patients to make decisions about their lives. Second, patients experienced a social and psychological cost of waiting. Third, patients varied in their ability to cope and demonstrated both passive and proactive coping strategies. Fourth, patients described the management effectiveness of clinicians and their ability or otherwise to provide support. CONCLUSIONS: A detailed qualitative approach has identified broad physical and psycho-social consequences for patients with knee injuries experiencing delays in clinical management. An overarching theme was the important potential of both systemic and interpersonal communication to improve patient well-being. A managed care pathway which enhanced information provision may provide immediate opportunities for improving patient well-being.

Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice.

BACKGROUND: A consulting method known as 'shared decision making' (SDM) has been described and operationalized in terms of several 'competences'. One of these competences concerns the discussion of the risks and benefits of treatment or care options-'risk communication'. Few data exist on clinicians' ability to acquire skills and implement the competences of SDM or risk communication in consultations with patients. OBJECTIVE: The aims of this study were to evaluate the effects of skill development workshops for SDM and the use of risk communication aids on the process of consultations. 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. Half the consultations were randomly selected for audio-taping, of which 352 patients attended and were audio-taped successfully. 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 allocated randomly to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations were audio-taped from each phase. Raters (independent, trained and blinded to study phase) assessed the audio-tapes using a validated scale to assess levels of patient involvement (OPTION: observing patient involvement), and to analyse the nature of risk information discussed. Clinicians completed questionnaires after each consultation, assessing perceived clinician-patient agreement and level of patient involvement in decisions. Multilevel modelling was carried out with the OPTION score as the dependent variable, and rater, consultation and clinician levels of data, standardized by rater within clinician. RESULTS: Following each of the interventions, the clinicians significantly increased their involvement of patients in decision making (OPTION score increased by 10.6 following risk communication training [95% confidence interval (CI) 7.9 -13.3; P < 0.001] and by 12.9 after SDM skill development (95% CI 10 -15.8, P < 0.001), a moderate effect size. The level of involvement achieved by the risk communication aids was significantly increased by the subsequent introduction of the skill development workshops (7.7 increase in OPTION score, 95% CI 3.4-12; P < 0.001). The alternative sequence (skills followed by risk communication aids) did not achieve this effect. The use of most risk information formats increased after the provision of specific risk communication aids (P < 0.001). Clinicians using the risk communication tools perceived significantly higher patient and clinician agreement on treatment (P < 0.001), patient satisfaction with information (P < 0.01), clinician satisfaction with decision (P < 0.01) and general overall satisfaction with the consultation (P < 0.001) than those who were exposed to SDM skill development workshops. CONCLUSIONS: These clinicians were able to acquire the skills to implement SDM competences and to use risk communication aids. Each intervention provided independent effects. Further progress towards greater patient involvement in health care decision making is possible, and skill development in this area should be incorporated into postgraduate professional development programmes.

Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice.

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.

Public attitudes towards the use of primary care patient record data in medical research without consent: a qualitative study.

OBJECTIVES: Recent legislative changes within the United Kingdom have stimulated professional debate about access to patient data within research. However, there is currently little awareness of public views about such research. The authors sought to explore attitudes of the public, and their lay representatives, towards the use of primary care medical record data for research when patient consent was not being sought. METHODS: 49 members of the public and four non-medical members of local community health councils in South Wales, UK gave their views on the value and acceptability of three current research scenarios, each describing access to data without patient consent. RESULTS: Among focus group participants, awareness of research in primary care was low, and the appropriateness of general practitioners as researchers was questioned. There was general support for research but also concerns expressed about data collection without consent. These included lack of respect and patient control over the process. Unauthorised access to data by external agencies was a common fear. Current data collection practices, including population based disease registers elicited much anxiety. The key informants were equally critical of the scenarios and generally less accepting. CONCLUSIONS: This exploratory study has highlighted a number of areas of public concern when medical records are accessed for research without patient consent. Public acceptability regarding the use of medical records in research cannot simply be assumed. Further work is required to determine how widespread such views are and to inform those advising on confidentiality issues.

A literature and medicine special study module run by academics in general practice: two evaluations and the lessons learnt.

This paper describes the design, delivery and evaluation of a nine week special study module on literature and medicine for third year undergraduate medical students, by tutors from an academic department of general practice. Three weeks of taught seminars are followed by three weeks of one on one meetings between individual students and tutors, leading to a seminar led by, and based on, materials prepared by the student. The final three weeks of the course are dedicated to completion of essays about areas chosen by students for in depth study.The course was evaluated on two separate occasions, using two different techniques: the first evaluation used a focus group technique to identify and explore relevant themes; the second used nominal group theory to assess whether the course worked educationally, and how it could be improved.In the main, the course was judged to meets its aims, with generally positive student comments, albeit with caveats and reservations. The subject matter was intellectually challenging for students and tutors. Further research into the optimal size for such groups, and a more formal evaluation of tutors' experiences is required.

Welsh women's comments about breast problems and the care given: a qualitative study in the community.

The aim of this study was to undertake a systematic analysis, using qualitative software, of the free text comments from a postal survey exploring women's experiences of breast symptoms, their expectations of treatment, knowledge of breast cancer risk factors and perceptions of risk, in 34 group general practices in South Wales. The 959 women who returned the questionnaire, out of 1126 (response rate 85%), comprised 497 women who consulted their general practitioner (GP) with a new breast symptom during the baseline data collection period and 462 controls who had not. When the survey was conducted the researchers did not know whether these women had cancer or had previously been treated for it. One-third (33.1%) of those returning the survey (n = 318) wrote comments. Compared to the rest, they were significantly more likely to have consulted their GP for a new breast symptom and to have stayed on at school and/or gone on to more education or training. The majority wrote about their own experience of breast symptoms and/or the care received in primary and secondary settings. The general tone was factual and when evaluation took place positive comments were more frequent than negative ones. Nothing suggested that the respondents had been upset or made more anxious by the preceding questions on such a potentially sensitive topic. Free text comments gathered in surveys can provide valuable data if systematically analysed. Doctors, particularly GPs, can be reassured that more women in this community sample who expressed an opinion on care were positive. The negative comments, however, highlight issues that still need to be addressed in therapeutic relationships.

The development of a new site-specific measure of quality of life for breast problems: the Cardiff breast scales.

The management of women presenting to primary care with symptoms of breast disease is of increasing interest given recent organisational changes aimed at improving accuracy and speed of referrals. As part of a randomised controlled trial, 1063 women were recruited following a primary care consultation for a variety of breast-related problems. In the absence of a suitable outcome measure for such women, a site-specific instrument was developed to complement a generic quality of life scale (SF-36). Items were generated using key informant interviews with health professionals. Draft scale items were piloted using a postal questionnaire and subsequent patient debrief interviews. A sample of respondents were also sent the same questionnaire I month later to assess test-retest reliability. Across the whole sample (n = 848), three factors were identified: 'general well-being', 'concerns' and 'relationships'. These factors accounted for 60% of total variance. Evidence of scale validity, reliability and responsiveness are reported for this new outcome measure for use in women presenting with breast problems.

It doesn't cost anything just to ask, does it? The ethics of questionnaire-based research.

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.