Shared decision-making interventions: An overview and a meta-analysis of their impact on vaccine uptake.

BACKGROUND: The interest in shared decision making (SDM) and the use of patient decision aids have increased significantly. Research indicates that this approach has benefits, and yet, implementation remains a challenge. To illustrate this development, we focus on vaccine hesitancy which has become a serious public health challenge during the COVID-19 pandemic. Various strategies have been used in healthcare, with limited success, to help patients overcome vaccine hesitancy. It is unclear whether SDM interventions can increase vaccination rates. AIMS: Our aim was two-fold: to provide an overview of SDM and the use of patient decision aids and to determine the effect of SDM interventions on vaccine uptake. METHODS: To provide an overview, we drew on our knowledge of the field and summarized the most recent systematic reviews. We examined the impact on vaccine hesitancy by searching for randomized controlled trials (RCTs) of SDM interventions, conducted a meta-analysis and calculated a pooled odds ratio. Additional outcomes were reported in a narrative synthesis. RESULTS: SDM is viewed as the pinnacle of patient-centred care, supported by an ethical imperative and by empirical evidence of benefits. We found 10 RCTs that met our inclusion criteria. SDM interventions significantly increased vaccine uptake compared to control groups (odds ratio = 1.45; 95% confidence interval [1.17-1.80]; p < 0.01). Some RCTs also reported significantly decreased decisional conflict and increased decision confidence. CONCLUSION: Future healthcare delivery systems will need to consider how to support the implementation of SDM. Interventions designed to facilitate this approach can represent a helpful, ethically defensible, strategy to increase vaccination rates.

Shared decision-making in epilepsy management.

Policy makers, clinicians, and patients increasingly recognize the need for greater patient involvement in clinical decision-making. Shared decision-making helps address these concerns by providing a framework for clinicians and patients to make decisions together using the best evidence. Shared decision-making is applicable to situations where several acceptable options exist (clinical equipoise). Such situations occur commonly in epilepsy, for example, in decisions regarding the choice of medication, treatment in pregnancy, and medication withdrawal. A talk model is a way of implementing shared decision-making during consultations, and decision aids are useful tools to assist in the process. Although there is limited evidence available for shared decision-making in epilepsy, there are several benefits of shared decision-making in general including improved decision quality, more informed choices, and better treatment concordance.

Interventions to improve risk communication in clinical genetics: systematic review.

OBJECTIVE: Effective risk communication may enable clients to participate effectively in decision-making about their health and health care. A systematic review of existing literature on risk communication in genetics, and its effects on key outcomes for clients, was undertaken. METHOD: Systematic searching of six electronic databases and data extraction from included studies; narrative synthesis of results. RESULTS: Twenty-eight studies were included, principally from cancer genetics. Sixteen communication interventions have been evaluated, generally showing improvements in cognitive outcomes for users, such as knowledge, understanding and risk perception, and without adverse effects on anxiety, cancer-related worry and depression. However, often it was the supportive or emotional elements of counselling that provided benefits to users, rather than the informational or educational elements. Similar results were found in 12 further studies of decision aids which also appear to achieve shorter consultations that can focus more on the supportive elements of counselling. CONCLUSION: For both communication models and decision aids, the supportive or emotional elements of counselling provided more benefits to users than the informational or educational elements. PRACTICE IMPLICATIONS: Debate is required on how to strike a balance between the medical model, its agenda and perceived requirements to disclose or discuss a range of issues and the sometimes competing goals of addressing users' concerns, needs for support, issues of loss and relationship problems.

Understanding patient experience of out-of-hours general practitioner services in South Wales: a qualitative study.

BACKGROUND: In the light of recent changes in the structure and provision of out-of-hours service in the UK, there is a need to re-assess the quality of care. One way to assess the quality of care is through patient experience. OBJECTIVES: This study aimed to explore patient expectations and help-seeking behaviour, in order to understand their relationship with satisfaction and experience of out-of-hours care. METHODS: 30 semistructured telephone interviews were carried out with users of the general practitioner out-of-hours service in Gwent, South Wales. The interviews explored users' experiences of using the service. A thematic analysis of transcripts was carried out using NUD*IST software. Comparison of data within and across codes facilitated the identification of explanatory constructs. Double coding of a sample of transcripts and discussion of emerging themes by members of the research team ensured the reliability of findings. RESULTS: Most (n = 25, 83%) respondents reported satisfaction with the overall service received but a few (n = 5, 17%) were dissatisfied. Patients generally had specific expectations of their consultation and there was a mismatch between patients' expectations of the service and what the service actually provides in some specific user groups. Unmet expectations resulted in subsequent, and in some cases, multiple consultations. CONCLUSIONS: Users' views and expectations may be used to inform service design and improve services, but the data also indicated a need to address user expectations of services, for example by enhanced information provision. Any such interventions to improve patient experience of out-of-hours care will need to be evaluated.

Personalised risk communication for informed decision making about taking screening tests.

BACKGROUND: There is a trend towards greater patient involvement in healthcare decisions. Adequate discussion of the risks and benefits associated with different choices is often required if involvement is to be genuine and effective. Achieving both the adequate involvement of consumers and informed decision making are now seen as important goals for any screening programme. Personalised risk estimates have been shown to be effective methods of risk communication in general, but the effectiveness of different strategies has not previously been examined. OBJECTIVES: To assess the effects of different types of personalised risk communication for consumers making decisions about taking screening tests. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2004), MEDLINE (1985 to December 2005), EMBASE (1985 to December 2005), CINAHL (1985 to December 2005), and PsycINFO (1989 to December 2005). Follow-up searches involved hand searching Preventive Medicine, citation searches on seven authors, and searching reference lists of articles. For the original version of this review (Edwards 2003c) we also searched CancerLit (1985 to 2001) and Science Citation Index Expanded (searched March 2002). SELECTION CRITERIA: Randomised controlled trials addressing the decision by consumers of whether or not to undergo screening, incorporating an intervention with a 'personalised risk communication element' and reporting cognitive, affective, or behavioural outcomes. A 'personalised risk communication element' is based on the individual's own risk factors for a condition (such as age or family history). It may be calculated from an individual's risk factors using formulae derived from epidemiological data, and presented as an absolute or relative risk or as a risk score, or it may be categorised into, for example, high, medium or low risk groups. It may be less detailed still, involving a listing, for example, of a consumer's risk factors as a focus for discussion and intervention. DATA COLLECTION AND ANALYSIS: Two authors independently assessed each trial for quality and extracted data. We extracted data about the nature and setting of the intervention, and relevant outcome data, along with items relating to methodological quality. We then used standard statistical methods of the Consumers and Communication Review Group to combine data using MetaView, including analysis according to different levels of detail of personalised risk communication, different condition for screening, and studies based only on high risk participants rather than people at 'average' risk. MAIN RESULTS: Twenty-two studies were included, nine of which were added in the 2006 update of this review. There was weak evidence, consistent with a small effect, that personalised risk communication (whether written, spoken or visually presented) increases uptake of screening tests (odds ratio (OR) 1.31 (random effects, 95% confidence interval (CI) 0.98 to 1.77). In three studies the interventions showed a trend towards more accurate risk perception (OR 1.65 (95% CI 0.96 to 2.81), and three other trials with heterogenous outcome measures showed improvements in knowledge with personalised risk interventions. There was little other evidence from these studies that the interventions promoted or achieved informed decision making by consumers about participation in screening. More detailed personalised risk communication may be associated with a smaller increase in uptake of tests. That is, for personalised risk communication which used and presented numerical calculations of risk, the OR for test uptake was 0.82 (95% CI 0.65 to 1.03). For risk estimates or calculations which were categorised into high, medium or low strata of risk, the OR was 1.42 (95% CI 1.07 to 1.89). For risk communication that simply listed personal risk factors the OR was 1.42 (95% CI 0.95 to 2.12). Over half of the included studies assessed interventions in the context of mammography. These studies showed similar effects to the overall dataset. The five studies examining risk communication in high risk individuals (individuals at higher risk due to, for example, a family history of breast cancer or other conditions) showed larger odds ratios for uptake of tests than the other studies (random effects OR 1.74; 95% CI 1.05 to 2.88). There were insufficient data from the included studies to report odds ratios on other key outcomes such as: intention to take tests, anxiety, satisfaction with decisions, decisional conflict, knowledge and resource use. AUTHORS' CONCLUSIONS: Personalised risk communication (as currently implemented in the included studies) may have a small effect on increasing uptake of screening tests, and there is only limited evidence that the interventions have promoted or achieved informed decision making by consumers.

Research on patients' views in the evaluation and improvement of quality of care.

The identification of methods for assessing the views of patients on health care has only developed over the last decade or so. The use of patients' views to improve healthcare delivery requires valid and reliable measurement methods. Four approaches are recognised: inclusion of patients' views in the information to those seeking health care, identification of patient preferences in episodes of care, patient feedback on delivery of health care, and patients' views in decision making on healthcare systems. Outcome measures for the evaluation of the use of patients' views should reflect the aims in terms of processes or outcomes of care, including possible negative consequences. Rigorous methodologies for the evaluation of methods have yet to be implemented.

"Doing prescribing": how might clinicians work differently for better, safer care.

Prescribing medicines is a cornerstone of medical practice. There is, however, ample evidence that the prescribing process is far from ideal when viewed from the perspective of patients who wish to understand why they should take medicine, what potential harm they might face, and how they might integrate medicine taking into the pattern of their life, beliefs, and attitudes. Misalignment between clinicians and patients about medicine taking leads to a multitude of problems. Recently, a concept known as concordance has been suggested, where the prescribing interaction is seen as a process where both the patient and professional views and beliefs about medication, and the associated harms and benefits, are shared and negotiated. This interaction depends on a communication process that is becoming known as shared decision making between clinicians and patients. Although there is as yet little evidence that this approach leads to improved clinical outcomes, ethical principles and the core values of medical practice suggest that involving patients in the prescribing process will lead to better, safer care.

Organisational change theory and the use of indicators in general practice.

General practices are making greater use of indicators to help shape and develop organisational arrangements supporting the delivery of health care. Debate continues concerning what exactly such indicators should measure and how they should be used to achieve improvement. Organisational theories can provide an analytical backdrop to inform the design of indicators, critique their construction, and evaluate their use. Systems theory, organisational development, social worlds theory, and complexity theory each has a practical contribution to make to our understanding of how indicators work in prompting quality improvements and why they sometimes don't. This paper argues that systems theory exerts the most influence over the use of indicators. It concludes that a strategic framework for quality improvement should take account of all four theories, recognising the multiple realities that any one approach will fail to reflect.

Assessing organisational development in primary medical care using a group based assessment: the Maturity Matrix.

OBJECTIVE: To design and develop an instrument to assess the degree of organisational development achieved in primary medical care organisations. DESIGN: An iterative development, feasibility and validation study of an organisational assessment instrument. SETTING: Primary medical care organisations. PARTICIPANTS: Primary care teams and external facilitators. MAIN OUTCOME MEASURES: Responses to an evaluation questionnaire, qualitative process feedback, hypothesis testing, and quantitative psychometric analysis (face and construct validity) of the results of a Maturity Matrix assessment in 55 primary medical care organisations. RESULTS: Evaluations by 390 participants revealed high face validity with respect to its usefulness as a review and planning tool at the practice level. Feedback from facilitators suggests that it helped practices to prioritise their organisational development. With respect to construct validity, there was some support for the hypothesis that training and non-training status affected the degree and pattern of organisational development. The size of the organisation did not have a significant impact on the degree of organisational development. CONCLUSION: This practice based facilitated group evaluation method was found to be both useful and enjoyable by the participating organisations. Psychometric validation revealed high face validity. Further developments are in place to ensure acceptability for summative work (benchmarking) and formative feedback processes (quality improvement).

Shared decision making: developing the OPTION scale for measuring patient involvement.

BACKGROUND: A systematic review has shown that no measures of the extent to which healthcare professionals involve patients in decisions within clinical consultations exist, despite the increasing interest in the benefits or otherwise of patient participation in these decisions. AIMS: To describe the development of a new instrument designed to assess the extent to which practitioners involve patients in decision making processes. DESIGN: The OPTION (observing patient involvement) scale was developed and used by two independent raters to assess primary care consultations in order to evaluate its psychometric qualities, validity, and reliability. STUDY SAMPLE: 186 audiotaped consultations collected from the routine clinics of 21 general practitioners in the UK. METHOD: Item response rates, Cronbach's alpha, and summed and scaled OPTION scores were calculated. Inter-item and item-total correlations were calculated and inter-rater agreements were calculated using Cohen's kappa. Classical inter-rater intraclass correlation coefficients and generalisability theory statistics were used to calculate inter-rater reliability coefficients. Basing the tool development on literature reviews, qualitative studies and consultations with practitioner and patients ensured content validity. Construct validity hypothesis testing was conducted by assessing score variation with respect to patient age, clinical topic "equipoise", sex of practitioner, and success of practitioners at a professional examination. RESULTS: The OPTION scale provided reliable scores for detecting differences between groups of consultations in the extent to which patients are involved in decision making processes in consultations. The results justify the use of the scale in further empirical studies. The inter-rater intraclass correlation coefficient (0.62), kappa scores for inter-rater agreement (0.71), and Cronbach's alpha (0.79) were all above acceptable thresholds. Based on a balanced design of five consultations per clinician, the inter-rater reliability generalisability coefficient was 0.68 (two raters) and the intra-rater reliability generalisability coefficient was 0.66. On average, mean practitioner scores were very similar (and low on the overall scale of possible involvement); some practitioner scores had more variation around the mean, indicating that they varied their communication styles to a greater extent than others. CONCLUSIONS: Involvement in decision making is a key facet of patient participation in health care and the OPTION scale provides a validated outcome measure for future empirical studies.

When is a shared decision not (quite) a shared decision? Negotiating preferences in a general practice encounter.

We consider whether there are situations in which 'shared decision making' in primary care is inherently problematic, such as in the demand for antibiotics to treat viral disorders. In such an instance there might be a lack of the equipoise necessary for a decision-making context in which apparent choices are genuine options. Using the techniques of discourse analysis on the transcript of a consultation with the parents of an infant with tonsillitis, we illustrate how a general practitioner's (GP's) efforts to reach a 'shared decision' come unstuck through a combination of the embedded power imbalance and the conflict between the GP's own prescription preferences and those of the parent.

How should effectiveness of risk communication to aid patients' decisions be judged? A review of the literature.

Risk-communication interventions are associated with benefits at both the individual and the public health level. However, the types of outcomes used to assess the effectiveness of risk-communication interventions vary greatly. This makes synthesis of the research in systematic review difficult, and limits both the implementation of advances in clinical practice and further research. This article reviews the outcomes used in risk-communication publications, particularly those addressing individual decisions about treatment. From the traditional cognitive and behavioral research outcomes of patient knowledge, risk perception, and compliance, the emphasis has shifted towards more affective outcomes, including satisfaction, assessment of the information provided and the decision-making process, and certainty about whether the best option has been chosen. These affective outcomes may be more specific and sensitive measures for risk-communication research. Further development and validation of measurement scales to address these issues is needed.

Shared decision-making in primary care: the neglected second half of the consultation.

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.

Shared decision making and the concept of equipoise: the competences of involving patients in healthcare choices.

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.

Personalised risk communication for informed decision making about entering screening programs.

BACKGROUND: There is a trend towards greater patient involvement in health care decisions. Adequate discussion of the risks and benefits associated with different choices is often required if involvement is to be genuine and effective. Achieving adequate involvement of consumers and informed decision making are now seen as important goals for any screening programme. Individualised risk estimates have been shown to be effective methods of risk communication in general, but the effectiveness of different strategies has not previously been examined. OBJECTIVES: To assess the effects of different types of individualised risk communication for consumers making decisions about participating in screening. SEARCH STRATEGY: We searched the Cochrane Consumers and Communication Review Group specialised register (searched March 2001), MEDLINE (1985 to 2001), EMBASE (1985 to 2001), CancerLit (1985 to 2001), CINAHL (1985 to 2001), ClinPSYC (1989 to 2001), and the Science Citation Index Expanded (searched March 2002). Follow-up searches involved hand searching Preventive Medicine, citation searches on seven authors, and searching reference lists of articles. SELECTION CRITERIA: Randomised controlled trials addressing the decision by consumers of whether or not to undergo screening, incorporating an intervention with a 'personalised risk communication element' and reporting cognitive, affective, or behavioural outcomes. A 'personalised risk communication element' is based on the individual's own risk factors for a condition (such as age or family history). It may be calculated from an individual's risk factors using formulae derived from epidemiological data, and presented as an absolute risk or as a risk score, or it may be categorised into, for example, high, medium or low risk groups. It may be less detailed still, involving a listing, for example, of a consumer's risk factors as a focus for discussion and intervention. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. Data about the nature and setting of the intervention, and the relevant outcome data were extracted, along with items relating to methodological quality. MAIN RESULTS: Thirteen studies were included. Personalised risk communication (whether written, spoken or visually presented) was associated with increased uptake of screening tests (odds ratio (OR) 1.5 (95% confidence interval (CI) 1.11 to 2.03). There was no evidence from these studies that this increase in uptake of tests was related to informed decision making by consumers. More detailed personalised risk communication was associated with a smaller increase in uptake of tests. That is, for personalised risk communication which used and presented numerical calculations of risk, the OR for test uptake was 1.22 (95% CI 0.56 to 2.68). For risk estimates or calculations which were categorised into high, medium or low strata of risk, the OR was 1.42 (95% CI 1.07 to 1.88). For risk communication that simply listed risk personal risk factors the OR was 1.7 (95% CI 1.17 to 2.48). Most of the included studies addressed mammography programmes. These studies showed slightly smaller effects than the overall dataset, again with numerical calculated risk estimates being associated with lower ORs for uptake of tests (OR 1.13; 95% CI 0.98 to 1.29) than the other categories of (less detailed) personalised risk communication. The four studies examining risk communication in high risk individuals showed larger odds ratios for uptake of tests than the other studies. The OR for numerical calculated risk estimates was 1.48 (95% CI 1.06 to 2.07), compared to 4.66 (95% CI 2.24 to 9.69) for categorised risk estimates and 2.64 (95% CI 1.42 to 4.9) for listed personal risk factors. There were insufficient data from the included studies to report odds ratios on other key outcomes such as: intention to take tests, anxiety, satisfaction with decisions, decisional conflict, knowledge and risk perception. REVIEWER'S CONCLUSIONS: Personalised risk communication (as currently implemented in the included studies) is associated with increased uptake of screening programmes, but this may not be interpretable as evidence of informed decision making by consumers.

Measuring the involvement of patients in shared decision-making: a systematic review of instruments.

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.

Organisational development in general practice: lessons from practice and professional development plans (PPDPs).

BACKGROUND: Improving the quality and effectiveness of clinical practice is becoming a key task within all health services. Primary medical care, as organised in the UK is composed of clinicians who work in independent partnerships (general practices) that collaborate with other health care professionals. Although many practices have successfully introduced innovations, there are no organisational development structures in place that support the evolution of primary medical care towards integrated care processes. Providing incentives for attendance at passive educational events and promoting 'teamwork' without first identifying organisational priorities are interventions that have proved to be ineffective at changing clinical processes. A practice and professional development plan feasibility study was evaluated in Wales and provided the experiential basis for a summary of the lessons learnt on how best to guide organisational development systems for primary medical care. RESULTS: Practice and professional development plans are hybrids produced by the combination of ideas from management (the applied behavioural science of organisational development) and education (self-directed adult learning theories) and, in conceptual terms, address the lack of effectiveness of passive educational strategies by making interventions relevant to identified system wide needs. In the intervention, each practice participated in a series of multidisciplinary workshops (minimum 4) where the process outcome was the production of a practice development plan and a set of personal portfolios, and the final outcome was a realised organisational change. It was apparent during the project that organisational admission to a process of developmental planning needed to be a stepwise process, where initial interest can lead to a fuller understanding, which subsequently develops into motivation and ownership, sufficient to complete the exercise. The advantages of introducing expert external facilitation were clear: evaluations of internal group processes were possible, strategic issues could be raised and explored and financial probity ensured. These areas are much more difficult to examine when only internal stakeholders are engaged in a planning process. CONCLUSIONS: It is not possible to introduce practice and professional development plans (organisational development and organisational learning projects) in a publicly funded health care system without first addressing existing educational and management structures. Existing systems are based on educational credits for attendance and emerging accountability frameworks (criteria checklists) for clinical governance. Moving to systems that are less summative and more formative, and based on the philosophies of continual quality improvement, require changes to be made in the relevant support systems in order achieve policy proposals.

Practice and professional development plans (PPDPs): results of a feasibility study.

BACKGROUND: Dissatisfaction with uniprofessional education structures as a means of improving the quality of healthcare has led to proposals to develop ways of integrating professional learning and organisational development. AIMS: Test the feasibility of introducing practice and professional development plans using a centrally sponsored project in Wales. DESIGN: Qualitative observational study. STUDY SAMPLE: All 541 practices in Wales were alerted to the project and invited to apply. A selection process was suggested to Health Authorities but not always efficiently conducted: 23 practices were selected and 18 participated in the process. METHOD: Central funding was made available to health authorities. The project framework was designed by an educational department and conceptualised as the development of personal portfolios linked to one key organisation change in each practice, facilitated by external consultants who would typically hold workshops or other events. An independent researcher using non-participant observation techniques at workshops and practices undertook documentary analysis and fieldwork in four health authorities. RESULTS: Difficulties were encountered with the process of implementing the project: marketing and practice selection inconsistencies delayed the work and it was difficult to recruit practices into the project. The lack of experienced individuals to do the work and practitioner suspicion about perceived 'management' agendas were significant problems. After initial hesitancies most practices appreciated the value of developing wider ownership and commitment to proposed practice changes. Organisations found it difficult to support individual completion of the personal portfolio component of the plans. The ability to develop systems for clinical services was dependent on having already established a culture of effective teamwork in the organisation. CONCLUSIONS: This work supports the view that organisational development has considerable potential for bringing about effective change, and individual contributions could form a valuable component of personal portfolios. We believe that the existing structures in education and management in the health service are not yet able to support these processes. Evidence from the fields of risk management and quality improvement all point to the need to develop effective organisational systems and the results of this feasibility study indicate that alternative models of sustaining organisational development need careful evaluation.

Understanding risk and lessons for clinical risk communication about treatment preferences.

This paper defines risk and its component elements and describes where clinical practice may be starting from in terms of what is reported in the literature about understanding risks and the information requirements of consumers. It notes briefly how theoretical models in the literature contribute to our understanding by providing a basis from which to summarise current evidence about the effects of healthcare interventions which address risks and risk behaviour. The situations or types of interventions in which risk related interventions are most effective are described, but a significant caveat is noted about the types of outcomes which have been reported in the literature and which are most appropriate to evaluate. The effects of "framing" variations in the information given to consumers and the ethical dilemmas these raise for a debate about "informed choice" in healthcare programmes are discussed. In response to both the practical and ethical dilemmas that arise from the current evidence, some of the areas where attention should be focused in the future are outlined so that both health gain and informed choice might be achieved. These include the use of decision aids, although their implementation is not widespread at present. Lessons from the current literature on how further progress can be made towards improved communication, discussion between professionals and consumers, and enhancing informed choice are discussed.

Judging the 'weight of evidence' in systematic reviews: introducing rigour into the qualitative overview stage by assessing Signal and Noise.

The 'weight of evidence' in a topic area can be judged by assessing the 'Signal' from available research publications and tempering the importance attached by the level of 'Noise' (the inverse of methodological quality). This assessment process has validity and reliability and can be applied to the 'qualitative overview' stage of systematic reviews. This enables the important themes and areas of relevance to the research question to be identified. Important findings from individual papers may also be identified providing further information which may not be evident from quantitative analysis. The findings from these more qualitative stages of analysis complement, but do not replace, quantitative analysis.