Background

Risk communication is an integral part of shared decision-making in health care. In the context of interventions for chronic diseases it represents a particular challenge for all health practitioners. By using two different quantitative formats to communicate risk level and effectiveness of a cholesterol-lowering drug, we posed the research question: how does the format of risk information influence patients’ decisions concerning therapy, patients’ satisfaction with the communication as well as confidence in the decision. We hypothesise that patients are less prone to accept therapy when the benefits of long-term intervention are presented in terms of prolongation of life (POL) in months compared to the absolute risk reduction (ARR). We hypothesise that patients presented with POL will be more satisfied with the communication and confident in their decision, suggesting understanding of the time-related term.

Methods/Design

In 2009 a sample of 328 general practitioners (GPs) in the Region of Southern Denmark was invited to participate in a primary care-based clinical trial among patients making real-life clinical decisions together with their GP. Interested GPs were cluster-randomised to inform patients about cardiovascular disease (CVD) risk and the effectiveness of statin therapy using either POL or ARR. The GPs attended a training session before informing their patients. Before training and after the trial period they received a questionnaire about their attitudes to risk communication and the use of numerical information. Patients’ redemptions of statin prescriptions will be registered in a regional prescription database to evaluate a possible association between redemption rates and effectiveness format. The Combined Outcome Measure for Risk Communication And Treatment Decision Making Effectiveness (COMRADE) questionnaire will be used to measure patients’ confidence and satisfaction with the risk communication immediately after the conversation with their GPs.

Discussion

This randomised clinical trial compares the impact of two effectiveness formats on real-life risk communication between patients and GPs, including affective patient outcomes and actual choices about acceptance of therapy. Though we found difficulties in recruiting GPs, according to the study protocol we have succeeded in engaging sufficient GPs for the trial, enabling us to perform the planned analyses.

Trial registration

ClinicalTrials.gov Protocol Registration System http://ww.clinicaltrials.gov/NCT01414751

Background

Shared decision-making and patients’ choice of interventions are areas of increasing importance, not least seen in the light of the fact that chronic conditions are increasing, interventions considered important for public health, and still non-acceptance of especially risk-reducing treatments of cardiovascular diseases (CVD) is prevalent. A better understanding of patients’ medication-taking behavior is needed and may be reached by studying the reasons why people accept or decline medication recommendations. The aim of this paper was to identify factors that may influence people’s decisions and reasoning for accepting or declining a cardiovascular preventive medication offer.

Methods

From a random sample of 4,000 people aged 40–59 years in a Danish population, 1,169 participants were asked to imagine being at increased risk of cardiovascular disease and being offered a preventive medication. After receiving ‘complete’ information about effectiveness of the medication they were asked whether they would accept medication. Finally, they were asked about reasons for the decision.

Results

A total of 725 (67%) of 1,082 participants accepted the medication offer. Even quite large effects of medication (up to 8 percentage points absolute risk reduction) had a smaller impact on acceptance to medication than personal experience with cardiovascular disease. Furthermore, increasing age of the participant and living with a partner were significantly associated with acceptance. Some 45% of the respondents accepting justified their choice as being for health reasons, and they were more likely to be women, live alone, have higher income and higher education levels. Among those who did not accept the medication offer, 56% indicated that they would rather prefer to change lifestyle.

Conclusions

Medication effectiveness seems to have a moderate influence on people’s decisions to accept preventive medication, while factors such as personal experience with cardiovascular disease may have an equally strong or stronger influence, indicating that practitioners could do well to carefully identify the reasons for their patients’ treatment decisions.

The principles of shared decision making are well documented but there is a lack of guidance about how to accomplish the approach in routine clinical practice. Our aim here is to translate existing conceptual descriptions into a three-step model that is practical, easy to remember, and can act as a guide to skill development. Achieving shared decision making depends on building a good relationship in the clinical encounter so that information is shared and patients are supported to deliberate and express their preferences and views during the decision making process. To accomplish these tasks, we propose a model of how to do shared decision making that is based on choice, option and decision talk. The model has three steps: a) introducing choice, b) describing options, often by integrating the use of patient decision support, and c) helping patients explore preferences and make decisions. This model rests on supporting a process of deliberation, and on understanding that decisions should be influenced by exploring and respecting “what matters most” to patients as individuals, and that this exploration in turn depends on them developing informed preferences.

Background

Despite policy and financial support for patient-experience surveys as feedback to modify clinical practice, their benefits and other effects remain unclear.

Aim

This study aimed to examine the perspective of GPs who have engaged with such tools.

Method

Qualitative semi-structured interviews with 30 GPs across south Wales, UK. The transcripts were analysed using a constant comparative method.

Results

The participants regarded patient feedback as highly important but felt that patient-experience surveys, as currently implemented, were hard to interpret. Reflecting on the doctor–patient interaction, participants perceived ambiguity about whether results were evaluating the individual or the GP practice, and whether they were directed towards the ‘practitioner-as-person’ or towards specific behaviours. A potential threat was posed in both interpretations, with the risk of damaging consequences for the practitioner and the nature of general practice. The tension between satisfying patients and performing good health care was a clearly voiced dilemma. Doctors did not feel confident in their ability to change in response to feedback, particularly outside a formal training environment.

Conclusion

Patient evaluation is seen as a key part of multisource feedback for practising doctors. Clarity is needed about the purpose of evaluation – whether for organisational or personal ‘feedback’, and whether formative or summative – and there is a need for attention to the process, with trained facilitators, to ensure that doctors gain from structured reflection, and can minimise the potential negative effects of evaluation.

Background

Inadequate health literacy has been associated with poor management of long-term health conditions and has been identified as a key social determinant of health outcomes. However, little is understood about how health literacy might develop over time or the processes by which people may become more health literate. Our objectives were to describe how patients with a long-term condition practice health literacy in the management of their health and communication with health professionals, how they become more health literate over time and their experience of using health services. We also sought to identify and describe the motivations, facilitators and barriers in the practice of health literacy in healthcare consultations.

Methods

We designed a longitudinal qualitative study using serial interviews with 18 participants to explore their experiences of learning to manage their condition and their experiences of health literacy when participating in healthcare processes. Participants were recruited from patient education programmes and were interviewed three times over a period of 9 months. A framework approach was used to analyse data.

Results

A model is presented that illustrates the development of health literacy along a trajectory that includes the development of knowledge, health literacy skills and practices, health literacy actions, abilities in seeking options and informed and shared decision making opportunities. Motivations and barriers to developing and practising health literacy skills partly reflected participants' characteristics but were also influenced by health professionals. Some participants developed their health literacy to a point where they became more involved in healthcare processes (including informed and shared decision-making).

Conclusions

Patients with a long-term condition can develop health literacy skills over time and put their skills into practice in becoming more active in healthcare consultations. Our findings have implications for developing health literacy interventions aimed at patient involvement in healthcare processes and improved self-management of long-term conditions.

Could be reduced by identifying and remedying poor communication skills early on

Background

Several models of GP out-of-hours provision exist in the UK but there is little detail about their effectiveness to meet users' needs and expectations.

Aim

To explore users' needs, expectations, and experiences of out-of-hours care, and to identify proposals for service redesign.

Setting

Service providers in urban (GP cooperative), mixed (hospital based), rural (private) locations in Wales.

Participants

Sixty recent service users or carers (20 in each location).

Method

Semi-structured telephone interviews; thematic analysis.

Results

Users' concerns were generally consistent across the three different services. Efficiency was a major concern, with repetitive triage procedures and long time delays at various stages in the process being problematic. Access to a doctor when required was also important to users, who perceived an obstructive gatekeeping function of preliminary contacts. Expectations moderated the relationship between user concerns and satisfaction. Where expectations of outcome were unfulfilled, participants reported greater likelihood of reconsulting with the same or alternative services for the same illness episode. Accurate expectations concerning contacts with the next administrative, nursing, or medical staff professional were managed by appropriate information provision.

Conclusion

Users require more streamlined and flexible triage systems. Their expectations need to be understood and incorporated into how services advise and provide services for users, and actively managed to meet the aims of both enhancing satisfaction and enabling users to cope with their condition. Better information and education about services are needed if users are to derive the greatest benefit and satisfaction. This may influence choices about using the most appropriate forms of care.

Background

Due to the non-specific nature of symptoms of UTI in children and low levels of urine sampling, the prevalence of UTI amongst acutely ill children in primary care is unknown.

Objectives

To undertake an exploratory study of acutely ill children consulting in primary care, determine the feasibility of obtaining urine samples, and describe presenting symptoms and signs, and the proportion with UTI.

Design

Exploratory, observational study.

Setting

Four general practices in South Wales.

Subjects

A total of 99 sequential attendees with acute illness aged less than five years.

Main outcome measure

UTI defined by >105 organisms/ml on laboratory culture of urine.

Results

Urine samples were obtained in 75 (76%) children. Three (4%) met microbiological criteria for UTI. GPs indicated they would not normally have obtained urine samples in any of these three children. However, all had received antibiotics for suspected alternative infections.

Conclusion

Urine sample collection is feasible from the majority of acutely ill children in primary care, including infants. Some cases of UTI may be missed if children thought to have an alternative site of infection are excluded from urine sampling. A larger study is needed to more accurately determine the prevalence of UTI in children consulting with acute illness in primary care, and to explore which symptoms and signs might help clinicians effectively target urine sampling.

Background and objective. Out-of-hours services for primary care provision are increasing in policy relevance. The aim of this qualitative study was to explore service users’ recent experiences of out-of-hours services and to identify suggestions for improvement for services and practitioners involved.

Methods. We used data from a cross-sectional survey of service users’ self-reported experiences of 13 out-of-hours centres in Wales. Three hundred and forty-one respondents provided free-text comments focusing on suggestions for improvement within the survey instrument (the Out-of-hours Patient Questionnaire). A coding framework was based on previous literature focusing on patients’ experiences of out-of-hours services, built upon and refined as it was systematically applied to the data. Emergent themes and subthemes were charted and interpreted to comprise the findings.

Results. Central themes emerged from users’ perspectives of the structure of out-of-hours services, process of care and outcomes for users. Themes included long waiting times, perceived quality of service user–practitioner communication, consideration for parents and children and accessibility of the service and medication. Suggestions for improving care were made across these themes, including triaging patients more effectively and efficiently, addressing specific aspects of practitioners’ communication with patients, reconsidering the size of areas covered by services and number of professionals required for the population covered, extending GP and pharmacy opening times and medication delivery services.

Conclusions. It is important to consider ways to address service users’ principal concerns surrounding out-of-hours services. Debate is required about prioritizing and implementing potential improvements to out-of-hours services in the light of resource constraints.

Background

General practitioners (GPs) and patients find it difficult to talk about risk of future disease, especially when patients have asymptomatic conditions, and treatment options are unlikely to cause immediate perceptible improvements in well-being. Further studies in risk communication training are needed. Aim:1) to systematically develop, describe and evaluate a complex intervention comprising a training programme for GPs in risk communication and shared decision-making, 2) to evaluate the effect of the training programme on real-life consultations between GPs and patients with high cholesterol levels, and 3) to evaluate patients' reactions during and after the consultations.

Methods/Design

The effect of the complex intervention, based around a training programme, will be evaluated in a cluster-randomised controlled trial with an intervention group and an active control group with 40 GPs and 280 patients in each group.

The GPs will receive a questionnaire at baseline and after 6 months about attitudes towards risk communication and cholesterol-reducing medication. After each consultation with a participating high cholesterol-patient, the GPs will complete a questionnaire about decision satisfaction (Provider Decision Process Assessment Instrument). The patients will receive a questionnaire at baseline and after 3 and 6 months. It includes questions about adherence to chosen treatment (Morisky Compliance Scale), self-rated health (SF-12), enablement (Patient Enablement Instrument), and risk communication and decision-making effectiveness (COMRADE Scale). Prescriptions, contacts to the health services, and cholesterol level will be drawn from the registers.

In each group, 12 consultations will be observed and tape-recorded. The patients from these 24 consultations will be interviewed immediately after the consultation and re-interviewed after 6 months.

Eight purposefully selected GPs from the intervention group will be interviewed in a focus group 6 months after participation in the training programme.

The process and context of the RISAP-study will be investigated in detail using an action research approach, in order to analyse adaptation of the intervention model to the specific context.

Discussion

This study aims at providing GPs and patients with a firm basis for active deliberation about preventive treatment options, with a view to optimising adherence to chosen treatment.

Trial registration

ClinicalTrials.gov Protocol Registration System NCT01187056

Background

Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours.

Methods/Design

This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse) from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted.

Discussion

Opportunistic engagement by health professionals potentially represents a cost effective medical intervention. This study integrates an existing, innovative intervention method with an innovative training model to enable clinicians to routinely use BCC, providing them with new tools to encourage and support people to make healthier choices. This trial will evaluate effectiveness in primary care and determine costs of the intervention.

Trial Registration

ISRCTN22495456

Background

Men considering the prostate specific antigen (PSA) test for prostate cancer, an increasingly common male cancer, are encouraged to make informed decisions, as the test is limited in its accuracy and the natural history of the condition is poorly understood. The Web-based PSA decision aid, Prosdex, was developed as part of the UK Prostate Cancer Risk Management Programme in order to help men make such informed decisions.

Objectives

The aim of this study was to evaluate the effect of the Web-based PSA decision aid, Prosdex, on informed decision making.

Methods

A Web-based randomized controlled trial was conducted in South Wales, United Kingdom. Men aged 50 to 75 who had not previously had a PSA test were randomly allocated to two intervention and two control groups. Participants in the intervention groups either viewed Prosdex or were given a paper version of the text. The main outcome measures were the three components of informed decision making: (1) knowledge of prostate cancer and PSA, (2) attitude toward PSA testing, (3) behavior using a proxy measure, intention to undergo PSA testing. Decisional conflict and anxiety were also measured as was uptake of the PSA test. Outcomes were measured by means of an online questionnaire for the Prosdex group, the paper version group, and one of two control groups. Six months later, PSA test uptake was ascertained from general practitioners’ records, and the online questionnaire was repeated. Results are reported in terms of the Mann-Whitney U-statistic divided by the product of the two sample sizes (U/mm), line of no effect 0.50.

Results

Participants were 514 men. Compared with the control group that completed the initial online questionnaire, men in the Prosdex group had increased knowledge about the PSA test and prostate cancer (U/mn 0.70; 95% CI 0.62 - 0.76); less favourable attitudes to PSA testing (U/mn 0.39, 95% CI 0.31 - 0.47); were less likely to undergo PSA testing (U/mn 0.40, 95% CI 0.32 - 0.48); and had less decisional conflict (U/mn 0.32, 95% CI 0.25 - 0.40); while anxiety level did not differ (U/mn 0.50, 95% CI 0.42 - 0.58). For these outcomes there were no significant differences between men in the Prosdex group and the paper version group. However, in the Prosdex group, increased knowledge was associated with a less favourable attitude toward testing (Spearman rank correlation [ρ] = -0.49, P < .001) and lower intention to undergo testing (ρ = -0.27, P = .02). After six months, PSA test uptake was lower in the Prosdex group than in the paper version and the questionnaire control group (P = .014). Test uptake was also lower in the control group that did not complete a questionnaire than in the control group that did, suggesting a possible Hawthorne effect of the questionnaire in favour of PSA testing.

Conclusions

Exposure to Prosdex was associated with improved knowledge about the PSA test and prostate cancer. Men who had a high level of knowledge had a less favourable attitude toward and were less likely to undergo PSA testing. Prosdex appears to promote informed decision making regarding the PSA test.

Trial Registration

ISRCTN48473735; http://www.controlled-trials.com/ISRCTN48473735 (Archived by WebCite at http://www.webcitation.org/5r1TLQ5nK)

Background

Web-based decision aids are known to have an effect on knowledge, attitude, and behavior; important components of informed decision making. We know what decision aids achieve in randomized controlled trials (RCTs), but we still know very little about how they are used and how this relates to the informed decision making outcome measures.

Objective

To examine men's use of an online decision aid for prostate cancer screening using website transaction log files (web-logs), and to examine associations between usage and components of informed decision making.

Methods

We conducted an observational web-log analysis of users of an online decision aid, Prosdex. Men between 50 and 75 years of age were recruited for an associated RCT from 26 general practices across South Wales, United Kingdom. Men allocated to one arm of the RCT were included in the current study. Time and usage data were derived from website log files. Components of informed decision making were measured by an online questionnaire.

Results

Available for analysis were 82 web-logs. Overall, there was large variation in the use of Prosdex. The mean total time spent on the site was 20 minutes. The mean number of pages accessed was 32 (SD 21) out of a possible 60 pages. Significant associations were found between increased usage and increased knowledge (Spearman rank correlation [ρ] = 0.69, P < .01), between increased usage and less favorable attitude towards PSA testing (ρ = -0.52, P < .01), and between increased usage and reduced intention to undergo PSA testing (ρ = -0.44, P < .01). A bimodal distribution identified two types of user: low access and high access users.

Conclusions

Increased usage of Prosdex leads to more informed decision making, the key aim of the UK Prostate Cancer Risk Management Programme. However, developers realistically have roughly 20 minutes to provide useful information that will support informed decision making when the patient uses a web-based interface. Future decision aids need to be developed with this limitation in mind. We recommend that web-log analysis should be an integral part of online decision aid development and analysis.

Trial Registration

ISRCTN48473735; http://www.controlled-trials.com/ISRCTN48473735 (Archived by WebCite at http://www.webcitation.org/5pqeF89tS)

Background

Communicating risk is part of primary prevention of coronary heart disease and stroke, collectively referred to as cardiovascular disease (CVD). In Australia, health organisations have promoted an absolute risk approach, thereby raising the question of suitable standardised formats for risk communication.

Methods

Sixteen formats of risk representation were prepared including statements, icons, graphical formats, alone or in combination, and with variable use of colours. All presented the same risk, i.e., the absolute risk for a 55 year old woman, 16% risk of CVD in five years. Preferences for a five or ten-year timeframe were explored. Australian GPs and consumers were recruited for participation in focus groups, with the data analysed thematically and preferred formats tallied.

Results

Three focus groups with health consumers and three with GPs were held, involving 19 consumers and 18 GPs.

Consumers and GPs had similar views on which formats were more easily comprehended and which conveyed 16% risk as a high risk. A simple summation of preferences resulted in three graphical formats (thermometers, vertical bar chart) and one statement format as the top choices. The use of colour to distinguish risk (red, yellow, green) and comparative information (age, sex, smoking status) were important ingredients. Consumers found formats which combined information helpful, such as colour, effect of changing behaviour on risk, or comparison with a healthy older person. GPs preferred formats that helped them relate the information about risk of CVD to their patients, and could be used to motivate patients to change behaviour.

Several formats were reported as confusing, such as a percentage risk with no contextual information, line graphs, and icons, particularly those with larger numbers.

Whilst consumers and GPs shared preferences, the use of one format for all situations was not recommended. Overall, people across groups felt that risk expressed over five years was preferable to a ten-year risk, the latter being too remote.

Conclusions

Consumers and GPs shared preferences for risk representation formats. Both groups liked the option to combine formats and tailor the risk information to reflect a specific individual's risk, to maximise understanding and provide a good basis for discussion.

Objectives

To describe the development, validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies (decision aids).

Design

Scale development study, involving construct, item and scale development, validation and reliability testing.

Setting

There has been increasing use of decision support technologies – adjuncts to the discussions clinicians have with patients about difficult decisions. A global interest in developing these interventions exists among both for-profit and not-for-profit organisations. It is therefore essential to have internationally accepted standards to assess the quality of their development, process, content, potential bias and method of field testing and evaluation.

Methods

Scale development study, involving construct, item and scale development, validation and reliability testing.

Participants

Twenty-five researcher-members of the International Patient Decision Aid Standards Collaboration worked together to develop the instrument (IPDASi). In the fourth Stage (reliability study), eight raters assessed thirty randomly selected decision support technologies.

Results

IPDASi measures quality in 10 dimensions, using 47 items, and provides an overall quality score (scaled from 0 to 100) for each intervention. Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sampled (n = 30), enabling discrimination. The inter-rater intraclass correlation for the overall quality score was 0.80. Correlations of dimension scores with the overall score were all positive (0.31 to 0.68). Cronbach's alpha values for the 8 raters ranged from 0.72 to 0.93. Cronbach's alphas based on the dimension means ranged from 0.50 to 0.81, indicating that the dimensions, although well correlated, measure different aspects of decision support technology quality. A short version (19 items) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 (CI 0.79 to 0.92).

Conclusions

This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies. The existing IPDASi provides an assessment of the quality of a DST's components and will be used as a tool to provide formative advice to DSTs developers and summative assessments for those who want to compare their tools against an existing benchmark.

Background

Decision support technologies (DSTs, also known as decision aids) help patients and professionals take part in collaborative decision-making processes. Trials have shown favorable impacts on patient knowledge, satisfaction, decisional conflict and confidence. However, they have not become routinely embedded in health care settings. Few studies have approached this issue using a theoretical framework. We explained problems of implementing DSTs using the Normalization Process Model, a conceptual model that focuses attention on how complex interventions become routinely embedded in practice.

Methods

The Normalization Process Model was used as the basis of conceptual analysis of the outcomes of previous primary research and reviews. Using a virtual working environment we applied the model and its main concepts to examine: the 'workability' of DSTs in professional-patient interactions; how DSTs affect knowledge relations between their users; how DSTs impact on users' skills and performance; and the impact of DSTs on the allocation of organizational resources.

Results

A conceptual analysis using the Normalization Process Model provided insight on implementation problems for DSTs in routine settings. Current research focuses mainly on the interactional workability of these technologies, but factors related to divisions of labor and health care, and the organizational contexts in which DSTs are used, are poorly described and understood.

Conclusion

The model successfully provided a framework for helping to identify factors that promote and inhibit the implementation of DSTs in healthcare and gave us insights into factors influencing the introduction of new technologies into contexts where negotiations are characterized by asymmetries of power and knowledge. Future research and development on the deployment of DSTs needs to take a more holistic approach and give emphasis to the structural conditions and social norms in which these technologies are enacted.

Background

Motivational interviewing approaches are currently recommended in primary prevention and treatment of cardiovascular disease (CVD) in general practice in Denmark, based on an empirical and multidisciplinary body of scientific knowledge about the importance of motivation for successful lifestyle change among patients at risk of lifestyle related diseases. This study aimed to explore and describe motivational aspects related to potential lifestyle changes among patients at increased risk of CVD following preventive consultations in general practice.

Methods

Individual interviews with 12 patients at increased risk of CVD within 2 weeks after the consultation. Grounded theory was used in the analysis.

Results

Ambivalence related to potential lifestyle changes was the core motivational aspect in the interviews, even though the patients rarely verbalised this experience during the consultations. The patients experienced ambivalence in the form of conflicting feelings about lifestyle change. Analysis showed that these feelings interacted with their reflections in a concurrent process. Analysis generated a typology of five different ambivalence sub-types: perception, demand, information, priority and treatment ambivalence.

Conclusion

Ambivalence was a common experience in relation to motivation among patients at increased risk of CVD. Five different ambivalence sub-types were found, which clinicians may use to explore and resolve ambivalence in trying to aid patients to adopt lifestyle changes. Future research is needed to explore whether motivational interviewing and other cognitive approaches can be enhanced by exploring ambivalence in more depth, to ensure that lifestyle changes are made and sustained. Further studies with a wider range of patient characteristics are required to investigate the generalisability of the results.

Objective To assess the effects on patients, clinicians, and the healthcare system of interventions before consultations to help patients or their representatives gather information in consultations by question asking.

Design Systematic review with meta-analysis.

Data sources Electronic literature searches of seven databases and hand searching of one journal and bibliographies of relevant articles.

Review methods Inclusion criteria included randomised controlled trials.

Main outcome measures Primary outcomes were question asking; patients’ anxiety, knowledge, and satisfaction; and length of consultation.

Results 33 randomised trials of variable quality involving 8244 patients were identified. A few studies showed positive effects. Meta-analyses showed small and statistically significantly increases in question asking (standardised mean difference 0.27, 95% confidence interval 0.19 to 0.36) and patients’ satisfaction (0.09, 0.03 to 0.16). Non-statistically significant changes occurred in patients’ anxiety before consultations (weighted mean difference −1.56, −7.10 to 3.97), patients’ anxiety after consultations (standardised mean difference −0.08, −0.22 to 0.06), patients’ knowledge (−0.34, −0.94 to 0.25), and length of consultation (0.10, −0.05 to 0.25). Interventions comprising written materials had similar effects on question asking, consultation length, and patients’ satisfaction as those comprising the coaching of patients. Interventions with additional training of clinicians had little further effect than those targeted at patients alone for patients’ satisfaction and consultation length.

Conclusions Interventions for patients before consultations produce small benefits for patients. This may be because patients and clinicians have established behaviours in consultations that are difficult to change. Alternatively small increases in question asking may not be sufficient to make notable changes to other outcomes.

Background

Prostate specific antigen (PSA) testing in primary care is an important and contentious issue. Due to concerns about the test and the value of early detection, countries such as the UK advocate ‘informed choice’ instead of population screening. It is not known whether this policy is actually adhered to in primary care. Furthermore, little is known of the experiences of men who face this decision.

Aim

To explore the experiences, understanding, and views of men who considered or undertook PSA testing in UK primary care.

Design of study

Qualitative interview-based study.

Setting

Primary care, Wales, UK.

Method

Semi-structured one-to-one interviews were conducted with 28 men, representing a range of clinical outcomes. Transcripts were coded and subjected to thematic analysis.

Results

Three themes were identified: the decision-making context, the locus of decision making, and uncertainty related to the PSA test.

Conclusion

The decision to undertake PSA testing was affected by both social and media factors and it did not appear to be a patient-led decision. The decision created considerable uncertainty for men and this uncertainty persisted after the test, even if the result was normal. Raised PSA led to further investigations and this exacerbated the uncertainty. Anxiety and regret were consequences of this uncertainty.

Background

To identify the benefits of a network in emergency and unscheduled care research, a six week scoping study was undertaken. Objectives were to: draw together stakeholders; identify and prioritise research topics; identify sites for recruitment to studies; and agree a research strategy for a network.

Methods

A workshop was held to discuss and agree a research strategy based on results from four activities: visits to established research centres in emergency and unscheduled care; a literature overview; interviews with stakeholders in a GP out-of-hours service; and an exploration of the potential for routine data to support research in emergency care.

Results

Participants attended the workshop from user groups, primary care, the ambulance service, social care, the national telephone based health helpline, the Welsh Assembly Government and the academic sector. Site visits identified opportunities for collaboration. Gaps in knowledge were identified concerning the effectiveness of alternative models of emergency care delivery. Interview data highlighted a lack of evidence related to the quality of out-of-hours provision of primary care. The All Wales Injury Surveillance System (AWISS) was found to offer the potential to use routine data to support quantitative studies in emergency care. Three key issues emerged across all activities: working across boundaries; patient involvement; and triage.

Conclusion

The study included views from patient, provider, policy and academic perspectives and built the case for a research network in emergency care. Now funded, TRUST (Thematic Research network for emergency and UnScheduled Treatment) will allow the development of research proposals, building of research teams and recruitment of sites and patients both in Wales and across the UK. It aims to address the imbalance between investment and research in this area and help support provision of 'the right care to the right people at the right time'.

Background

Shared decision making is an important aspect of patient centredness. Lack of this consulting behaviour is a common reason for failure in the Membership of the Royal College of General Practitioners (MRCGP) consulting skills examination.

Aim

To investigate candidates' performance in shared decision making and overall performance in the MRCGP consulting skills assessment compared with an independently validated measure, the OPTION (‘observing patient involvement’) scale.

Design

Cross-sectional study.

Setting

MRCGP examination, UK.

Participants

Two hundred and fifty-two consultations submitted by 36 GPs submitting seven consultations per videotape.

Method

A stratified sample of 63 candidates, 21 each from fail, pass and merit selected from candidates in the MRCGP consulting skills examination, were approached for participation. Participants' examination videotapes were independently assessed for shared decision making using the OPTION scale by two non-clinical raters.

Results

Thirty-six candidates (of 63; 57%) who participated were no different from non-participants. Candidates who passed the ‘sharing management options’ in the MRCGP had significantly higher OPTION scores than those who did not (35.4 versus 27.3; mean difference = 8.1, P = 0.044). There was a significant difference between OPTION scores of MRCGP candidates with ‘fail’ and ‘pass’ (including pass with merit): 28.6 versus 36.1, 95% confidence interval CI = 1.13 to 13.87. Scores decreased as clinician age increased but were not significantly associated with sex of GP, age or sex of patient or consultation duration. The probability of passing the MRGCP increased as OPTION scores increased.

Conclusion

This study demonstrated concurrent validity of the MRCGP consulting skills assessment of sharing management options against an independent validated instrument for shared decision making, the OPTION scale. Candidates who performed best in the MRCGP exhibited high scores with OPTION. This study provides the basis for further work to demonstrate evidence for the potential of training for professional assessment to improve consulting competence.

Background

Informed decision making is the theoretical basis in the UK for men's decisions about Prostate Specific Antigen (PSA) testing for prostate cancer testing. The aim of this study is to evaluate the effect of a web-based PSA decision-aid, Prosdex, on informed decision making in men. The objective is to assess the effect of Prosdex on six specific outcomes: (i) knowledge of PSA and prostate cancer-related issues – the principal outcome of the study; (ii) attitudes to testing; (iii) decision conflict; (iv) anxiety; (v) intention to undergo PSA testing; (vi) uptake of PSA testing. In addition, a mathematical simulation model of the effects of Prosdex will be developed.

Methods

A randomised controlled trial with four groups: two intervention groups, one viewing Prosdex and the other receiving a paper version of the site; two control groups, the second controlling for the potential Hawthorn effect of the questionnaire used with the first control group. Men between the ages of 50 and 75, who have not previously had a PSA test, will be recruited from General Practitioners (GPs) in Wales, UK. The principal outcome, knowledge, and four other outcome measures – attitudes to testing, decision conflict, anxiety and intention to undergo testing – will be measured with an online questionnaire, used by men in three of the study groups. Six months later, PSA test uptake will be ascertained from GP records; the online questionnaire will then be repeated. These outcomes, and particularly PSA test uptake, will be used to develop a mathematical simulation model, specifically to consider the impact on health service resources.

Trial registration

Current Controlled Trial: ISRCTN48473735.

Background

Field-testing is a quality assurance criterion in the development of patient decision-support technologies (PDSTs), as identified in the consensus statement of the International Patient Decision Aids Standards Collaboration. We incorporated field-testing into the development of a Web-based, prostate-specific antigen PDST called Prosdex, which was commissioned as part of the UK Prostate Cancer Risk Management Programme.

Objectives

The aim of this study was to develop a model for the future field-testing of PDSTs, based on the field-testing of Prosdex. Our objectives were (1) to explore the reactions of men to evolving prototypes of Prosdex, (2) to assess the effect of these responses on the development process, and (3) to develop a model for field-testing PDSTs based on the responses and their effect on the development process.

Methods

Semistructured interviews were conducted with the men after they had viewed evolving prototypes of Prosdex in their homes. The men were grouped according to the prototype viewed. Men between 40 and 75 years of age were recruited from two family practices in different parts of Wales, United Kingdom. In the interviews, the men were asked for their views on Prosdex, both as a whole and in relation to specific sections such as the introduction and video clips. Comments and technical issues that arose during the viewings were noted and fed back to the developers in order to produce subsequent prototypes.

Results

A total of 27 men were interviewed, in five groups, according to the five prototypes of Prosdex that were developed. The two main themes from the interviews were the responses to the information provided in Prosdex and the responses to specific features of Prosdex. Within these themes, two of the most frequently encountered categories were detail of the information provided and balance between contrasting viewpoints. Criticisms were encountered, particularly with respect to navigation of the site. In addition, we found that participants made little use of the decision-making scale. The introduction of an interactive contents page to prototype 2 was the main change made to Prosdex as a result of the field-testing. Based on our findings, a model for the field-testing of PDSTs was developed, involving an exploratory field-testing stage between the planning stage and the development of the first prototype, and followed by the prototype field-testing stage, leading to the final PDST.

Conclusions

In the field-testing of Prosdex, a Web-based prostate-specific antigen PDST, the responses of interviewed men were generally favorable. As a consequence of the responses, an interactive contents page was added to the site. We developed a model for the future field-testing of PDSTs, involving two stages: exploratory field-testing and prototype field-testing.

Background

Shared decision making (SDM) involves patients and doctors contributing as partners to treatment decisions. It is not known whether or to what extent SDM contributes to the welfare arising from a consultation, and how important this contribution is relative to other attributes of a consultation.

Aim

To identify patient preferences for SDM relative to other utility bearing attributes of a consultation.

Design of study

In parallel with a randomised trial in training GPs in SDM competencies and risk communication skills, a discrete choice experiment exercise was conducted to assess patients' utilities.

Setting

Twenty general practices in South Wales, UK

Method

Five hundred and eighty-four responders from 747 patients attending the randomised trial (response rate = 78%). All patients had one of four conditions (atrial fibrillation, menorrhagia, menopausal symptoms or prostatism) and attended a consultation with a doctor in their own practice. Patients were randomised to attend a consultation either with a doctor who had received no training in the study or risk communication training alone or SDM training alone, or both combined.

Results

Five key utility bearing attributes of a consultation were identified. All significantly influenced patient's choice of preferred consultation style (P<0.001). Larger increases in utility were associated with changes on ‘doctor listens’ attribute, followed by easily understood information, a shared treatment decision, more information and longer consultation. Utilities were influenced by whether the doctor had received risk communication training alone or SDM training alone, or both combined, prior to the consultations. The randomised trial itself had identified that the communication processes of these consultations changed significantly, with greater patient involvement in decision making, after the training interventions.

Conclusion

Shared treatment decisions were valued less than some other attributes of a consultation. However, patient utilities for such involvement appeared responsive to changes in experiences of consultations. This suggests that SDM may gain greater value among patients once they have experienced it.

Objective To develop a set of quality criteria for patient decision support technologies (decision aids).

Design and setting Two stage web based Delphi process using online rating process to enable international collaboration.

Participants Individuals from four stakeholder groups (researchers, practitioners, patients, policy makers) representing 14 countries reviewed evidence summaries and rated the importance of 80 criteria in 12 quality domains ona1to9 scale. Second round participants received feedback from the first round and repeated their assessment of the 80 criteria plus three new ones.

Main outcome measure Aggregate ratings for each criterion calculated using medians weighted to compensate for different numbers in stakeholder groups; criteria rated between 7 and 9 were retained.

Results 212 nominated people were invited to participate. Of those invited, 122 participated in the first round (77 researchers, 21 patients, 10 practitioners, 14 policy makers); 104/122 (85%) participated in the second round. 74 of 83 criteria were retained in the following domains: systematic development process (9/9 criteria); providing information about options (13/13); presenting probabilities (11/13); clarifying and expressing values (3/3); using patient stories (2/5); guiding/coaching (3/5); disclosing conflicts of interest (5/5); providing internet access (6/6); balanced presentation of options (3/3); using plain language (4/6); basing information on up to date evidence (7/7); and establishing effectiveness (8/8).

Conclusions Criteria were given the highest ratings where evidence existed, and these were retained. Gaps in research were highlighted. Developers, users, and purchasers of patient decision aids now have a checklist for appraising quality. An instrument for measuring quality of decision aids is being developed.