What has been the effect on trial outcome assessments of a decade of patient participation in OMERACT?

OBJECTIVE: Since 2002, 58 patients have participated as collaborating partners in 6 Outcome Measures in Rheumatology (OMERACT) conferences. Little is known about how they engage with researchers and how they have influenced conference outcomes. METHODS: A responsive evaluation was carried out, including a thematic document analysis of conference proceedings and gray literature, participant observation, and 38 interviews with patients and professionals representing research, industry, and regulators. Interview transcripts were subjected to an inductive content analysis. RESULTS: The role of patients has evolved from a single focus group in 2002 to full integration in all parts of the conference in 2012. Longterm engagement has made a significant change in the scope and conduct of rheumatology research. It has enriched the research agenda by identifying previously neglected outcome domains such as fatigue, sleep disturbances, and flares, and it has contributed to more patient-relevant outcomes in clinical trials. Facilitating factors have been a strong commitment of the leadership, adequate selection procedure, inclusive conference design, interactive and encouraging moderation style, and self-organized support. The intensity of the program and doubts regarding the representativeness of the patient group were still seen as challenges for the future. CONCLUSION: Making patient participation an integral part of the vision and procedures of OMERACT has significantly contributed to the success of OMERACT. It has changed the perceptions and beliefs of many participants. Full use of patients' experiential knowledge before and during the conference is still challenging.

Facilitating and inhibiting factors for long-term involvement of patients at outcome conferences--lessons learnt from a decade of collaboration in OMERACT: a qualitative study.

OBJECTIVE: Several studies have provided insights into the conditions for successful patient involvement in health research. We recently demonstrated that long-term engagement with people with rheumatic conditions in international outcome research led to significant changes in the research agenda in the field of rheumatology. This article explores facilitating and inhibiting factors for long-term involvement of patients as collaborative partners at five Outcome Measures in Rheumatology (OMERACT) conferences. DESIGN: Responsive evaluation, starting with a thematic document analysis of conference proceedings and the grey literature, followed by 38 qualitative interviews. Interview transcripts were subjected to inductive content analysis. SETTING: 5 international OMERACT conferences between 2002 and 2012. PARTICIPANTS: Patient delegates (n=16) and professional delegates representing researchers (n=14), pharmaceutical industry and regulators (n=2). RESULTS: Combined review of the document analysis and interview data revealed five main facilitators and three main barriers. Patient engagement as full participants at OMERACT conferences was enhanced by: strong leadership commitment and the presence of change agents, a clear selection procedure, an inclusive consensus-based conference design, individualised and self-organised support, an interactive and encouraging moderation style during discussion groups. Barriers were related to the intensity of the conference programme, scepticism among researchers and doubts about the representativeness of the patient group. CONCLUSIONS: This study concludes that developing a sustainable structure for funding, selection and support of patient delegates, as well as adjusting conference design and moderation style, contributes not only towards facilitating direct dialogue between all stakeholders but also towards enhancing mutual understanding and the successful incorporation of the patient perspective in an outcome conference such as OMERACT.

How can clinical practice guidelines be adapted to facilitate shared decision making? A qualitative key-informant study.

BACKGROUND: To explore how clinical practice guidelines can be adapted to facilitate shared decision making. METHODS: This was a qualitative key-informant study with group discussions and semi-structured interviews. First, 75 experts in guideline development or shared decision making participated in group discussions at two international conferences. Next, health professionals known as experts in depression or breast cancer, experts on clinical practice guidelines and/or shared decision making, and patient representatives were interviewed (N=20). Using illustrative treatment decisions on depression or breast cancer, we asked the interviewees to indicate as specifically as they could how guidelines could be used to facilitate shared decision making. RESULTS: Interviewees suggested some generic strategies, namely to include a separate chapter on the importance of shared decision making, to use language that encourages patient involvement, and to develop patient versions of guidelines. Recommendation-specific strategies, related to specific decision points in the guideline, were also suggested: These include structuring the presentation of healthcare options to increase professionals' option awareness; structuring the deliberation process between professionals and patients; and providing relevant patient support tools embedded at important decision points in the guideline. CONCLUSIONS: This study resulted in an overview of strategies to adapt clinical practice guidelines to facilitate shared decision making. Some strategies seemed more contentious than others. Future research should assess the feasibility and impact of these strategies to make clinical practice guidelines more conducive to facilitate shared decision making.

"If i wasn't this robust": patients' expectations and experiences at the Outcome Measures in Rheumatology Conference 2010.

BACKGROUND: Patients are incidentally involved in scientific conferences as collaborating partners. Little is known about how they engage with researchers. OBJECTIVE: The purpose of this study was to explore the expectations and experiences of new patients to better understand the specific features of collaborative research during conferences in its complexity. STUDY DESIGN: After a thematic literature review, we conducted fourteen interviews with eight delegates: four men and four women with three rheumatic diseases and representing five countries. They participated for the first time in the biannual conference on Outcome Measures in Rheumatology (OMERACT) in 2010. Data were subjected to a thematic content analysis. RESULTS: Before the conference, patient participants had felt privileged to be invited but felt insufficiently prepared and uncertain about what was expected from their participation. They had anticipated a learning experience and had hoped to be able to make a contribution. Most experienced the conference program as physically and mentally challenging, partially due to poor moderation or lack of individual support. They doubted their input had been beneficial. After the conference these patients also described their participation as having been a valuable, meaningful, and learning experience. Although they presumed that they had not been very productive, they expected their contribution would be more effective at future conferences. CONCLUSIONS: Patient delegates attending a scientific conference need clear information about their role prior to the event. Personalized support and a facilitative moderation style during sessions are advantageous for maximizing valuable contributions. Participation leads to personal learning curves and various benefits.

Involving patient research partners has a significant impact on outcomes research: a responsive evaluation of the international OMERACT conferences.

OBJECTIVE: To assess the inclusion of patients as international research partners in Outcome Measures in Rheumatology (OMERACT) conferences and how this has influenced the scope and conduct of outcomes research in rheumatology. DESIGN: A thematic content analysis of OMERACT internal documents, publications and conference proceedings, followed by a responsive evaluation including 32 qualitative semistructured interviews. SETTING: The international, biannual research conference OMERACT 10 (Malaysia, 2010). PARTICIPANTS: Senior researchers (n=10), junior researchers (n=2), representatives of the pharmaceutical industry and regulators (n=2), conference staff (n=2), new patient delegates (n=8) and experienced patient delegates (n=8). RESULTS: The role of patients evolved over 10 years from a single patient focus group to full participation in all areas of the meeting and inclusion in research group meetings between conferences. Five main categories of impact emerged: widening the research agenda; including patient relevant outcomes in core sets; enhancing patient reported instruments; changing the culture of OMERACT and consequences outside OMERACT. Patient participants identified previously neglected outcome domains such as fatigue, sleep disturbances and flares which prompted collaborative working on new programmes of research. Specific benefits and challenges for patients and professionals were identified, such as personal fulfilment, widening of research interests, difficulties in establishing equal partnerships and concerns about loss of research rigour. CONCLUSIONS: Including patients as partners in OMERACT conferences has widened its focus and adjusted the way of working. It has resulted in new developments in the research agenda and the use of more patient-relevant outcomes in clinical trials. These collaborations have influenced perceptions and beliefs among many patients and researchers, and led to wider patient involvement as partners in research.

Interprofessional education about shared decision making for patients in primary care settings.

With an increasingly complex array of interventions facing healthcare professionals and patients, coupled with a potentially diverse number of professionals operating within the primary care team, the adoption of shared decision making (SDM) - with or without patients' decision aids - in an interprofessional manner is essential to ensure the highest quality of care for patients. In this article, we propose a framework for interprofessional education about SDM targeted to primary care settings. Five areas of knowledge and skills were agreed to be essential for all relevant stakeholders for interprofessional education in SDM to be successful: understanding the concept of SDM; acquiring relevant communication skills to facilitate SDM; understanding interprofessional sensitivities; understanding the roles of different professions within the relevant primary care group; and acquiring relevant skills to implement SDM. We suggest a series of teaching methods for the aforementioned areas, using principles from adult learning.

Shared decision making in the Netherlands, is the time ripe for nationwide, structural implementation?

WHAT ABOUT POLICY REGARDING SDM? The Dutch health care system has been reformed in 2006 to make it more patient-oriented and demand-driven. We shortly describe four strategies of this health care reform. Although research projects are now fully spread over the country, a coordinated research agenda on SDM is lacking. WHAT ABOUT TOOLS - DECISION SUPPORT FOR PATIENTS? The Dutch governmental healthcare internet portal for patients hosts 16 patient decision aids. WHAT ABOUT PROFESSIONAL INTEREST AND IMPLEMENTATION? There is quite a strong patient participation movement in the Netherlands, on macro and meso level. Limited effort, related to the local research projects has been put into training professionals in SDM skills. WHAT DOES THE FUTURE LOOK LIKE? We need concerted action on the level of educating health care professionals, empowering patients, making patient decision aids easily accessible, supporting the professionals in this new task, and measuring the process of SDM in performance indicators used in quality assurance. The Dutch Platform for SDM that will be launched in Maastricht in June 2011 is therefore a timely and relevant initiative.

Measurement of shared decision making - a review of instruments.

The last years have seen a clear move towards shared decision making (SDM) and increased patient involvement in many countries. However, as the field of SDM research is still relatively young, new instruments for the measurement of (shared) decision making (process, outcome and surrounding elements) are constantly being developed. Thus, the aims of this structured review were to give an update on current developments regarding the measurement in the field of SDM, as well as to give a short overview of published and unpublished instruments. We conducted an electronic literature search in PubMed and the Web of Science database, performed hand searches of relevant journals and contacted key authors in the field. We found eight scales that have been subjected to further psychometric testing, eleven new and psychometrically tested instruments and nine developments that are still in the publishing process. The results show that there is a trend towards measuring SDM processes from a dyadic approach (assessing both the patient's and the clinician's perspective). More and more scales have been developed and tested in languages other than English, which indicates the growing research efforts in various countries. While reliability of most scales is good, they differ in their extent of validation. Further psychometric testing is needed, as well as the development of a theoretical measurement framework in order to improve consistency of measured constructs across research groups.

Small but important errors in cardiovascular risk calculation by practice nurses: a cross-sectional study in randomised trial setting.

BACKGROUND: Practice nurses play an increasingly important role in the prevention of cardiovascular diseases but we do not have evidence about the accuracy of their cardiovascular risk assessments during real practice consultations. OBJECTIVES: To examine how nurses perform with regard to absolute 10-year cardiovascular risk assessment in actual practice. DESIGN: Cross-sectional study. SETTING: This study was nested in the IMPALA study, a clustered randomised controlled trial involving 24 general practices in The Netherlands. PARTICIPANTS: 24 practice nurses, trained in 10-year cardiovascular risk assessment, calculated the risk of a total of 421 patients without established cardiovascular diseases but eligible for cardiovascular risk assessment. METHODS: The main outcome measure was the accuracy of risk assessments, defined as (1) the difference between the 10-year cardiovascular risk percentage calculated by nurses and an independent assessor, and (2) the agreement between the treatment categories assigned by the nurses (low, moderate or high risk) and those assigned by the independent assessor. RESULTS: Thirty-one (7.4%) of the calculated risk percentages differed by more than our preset limits, 25 (81%) being underestimations. Elderly patients (OR 1.1, 95% CI 1.0-1.1), male patients (vs. female OR 3.1, 95% CI 1.2-7.3), and smoking patients (vs. non-smoking OR 3.8, 95% CI 1.7-8.9) were more likely to have their cardiovascular risk miscalculated. Ten (28%) of the 36 patients who should be assigned to the high-risk treatment category according to the independent calculation, were missed as high-risk patients by the practice nurses. CONCLUSIONS: The overall standard of accuracy of cardiovascular risk assessment by trained practice nurses in actual practice is high. However, a significant number of high-risk patients were misclassified, with the probability that it led to missed opportunities for risk-reducing interventions. As cardiovascular risk assessments are frequently done by nurses in general practice, further specific training should be considered to prevent undertreatment.

Improving lifestyle and risk perception through patient involvement in nurse-led cardiovascular risk management: a cluster-randomized controlled trial in primary care.

OBJECTIVE: To determine if lifestyle improved at a short term through an intervention to involve patients in cardiovascular risk management by the practice nurse. METHODS: The IMPALA study (2006, the Netherlands) was a cluster-randomised controlled trial involving 25 general practices and 615 patients who were eligible for cardiovascular risk management. The intervention consisted of (1) individual 10-year cardiovascular risk assessment, (2) risk communication, (3) use of a decision aid and (4) adapted motivational interviewing, applied by practice nurses in two consultations. Outcomes were smoking, alcohol, diet, physical activity and the secondary outcomes risk perception, anxiety, confidence about the decision and satisfaction with the communication, measured at baseline and after 12 weeks. RESULTS: Patients of both groups improved their lifestyle, but no relevant significant differences between the groups were found. Intervention group patients improved in terms of the appropriateness of risk perception, although not significantly. Intervention group patients improved significantly in terms of appropriateness of anxiety and were more satisfied with the communication compared to control group patients. CONCLUSION: The intervention seems to have improved the patients' risk perception, anxiety and satisfaction with the communication, which are important conditions for shared decision making. However, we found no additional effect of the intervention on lifestyle.

Involving patients in cardiovascular risk management with nurse-led clinics: a cluster randomized controlled trial.

BACKGROUND: Preventive guidelines on cardiovascular risk management recommend lifestyle changes. Support for lifestyle changes may be a useful task for practice nurses, but the effect of such interventions in primary prevention is not clear. We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk. METHODS: We performed a cluster randomized controlled trial in 25 practices that included 615 patients. The intervention consisted of nurse-led cardiovascular risk management, including risk assessment, risk communication, a decision aid and adapted motivational interviewing. The control group received a minimal nurse-led intervention. The self-reported outcome measures at one year were smoking, alcohol use, diet and physical activity. Nurses assessed 10-year cardiovascular mortality risk after one year. RESULTS: There were no significant differences between the intervention groups. The effect of the intervention on the consumption of vegetables and physical activity was small, and some differences were only significant for subgroups. The effects of the intervention on the intake of fat, fruit and alcohol and smoking were not significant. We found no effect between the groups for cardiovascular 10-year risk. INTERPRETATION: Nurse-led risk communication, use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk, despite significant within-group differences.

Lonely patients in general practice: a call for revealing GPs' emotions? A qualitative study.

BACKGROUND: Loneliness is a universal phenomenon that influences one's health and health perception. GPs are confronted with lonely people quite often. Yet, what GPs think of this phenomenon and how they deal with emotions lonely patients evoke is not known. OBJECTIVE: We aimed to explore GPs' experiences with lonely patients. We wanted to gain insight in GPs' feelings regarding consultations with lonely patients and potential resulting behaviour from these feelings. METHODS: We performed a qualitative study based on semi-structured interviews. We interviewed 20 Dutch GPs. Transcripts were analysed according to a grounded theory-like method in order to bring to surface key concepts and relations between them. RESULTS: GPs considered loneliness as something subjective, a feeling. They found it relevant to know whether their patients were lonely. However, they had difficulty defining their task and experienced a lack of therapeutic options. Beside feelings of pity and interest, lonely patients could evoke feelings of frustration and powerlessness. These feelings were more pronounced when patients were chronically lonely and could cause GPs to spend less time on these patients or refer them more often. GPs did not constructively use their own emotions during consultation. CONCLUSIONS: When confronted with lonely patients, a helpful distinction could be made between transitory and chronic loneliness. Chronically lonely patients are more likely to evoke negative feelings and behaviour in their GPs. GPs should try to recognize these emotions and make sure they do not harmfully influence consultation.

Primary care patients' recognition of their own risk for cardiovascular disease: implications for risk communication in practice.

PURPOSE OF REVIEW: Guidelines on primary prevention of cardiovascular disease emphasize identifying high-risk patients for intensive risk-reducing management. These guidelines recommend the identification of individuals with high risk using risk score sheets or risk tables. Patients' misperceptions of risk seem to hamper implementation of the high-risk approach. How appropriate are the risk perceptions of patients? What is known about effective ways of risk communication? RECENT FINDINGS: Cardiovascular risk is often perceived inappropriately in primary care populations; by nearly four in five high-risk patients (incorrect optimism), and by one in five low-risk patients (incorrect pessimism). Communicating cardiovascular risk by means of natural frequencies seems effective to correct inappropriate risk perception, though effects are small. SUMMARY: In communicating cardiovascular disease risk, primary care physicians must be aware that they mostly encounter low-risk patients and that the perceived risk does not necessarily correspond with the actual risk. Professionals should be skilled in the use of effective formats for risk communication that are ideally integrated within patient decision aids for cardiovascular risk management.

Improving patient adherence to lifestyle advice (IMPALA): a cluster-randomised controlled trial on the implementation of a nurse-led intervention for cardiovascular risk management in primary care (protocol).

BACKGROUND: Many patients at high risk of cardiovascular diseases are managed and monitored in general practice. Recommendations for cardiovascular risk management, including lifestyle change, are clearly described in the Dutch national guideline. Although lifestyle interventions, such as advice on diet, physical exercise, smoking and alcohol, have moderate, but potentially relevant effects in these patients, adherence to lifestyle advice in general practice is not optimal. The IMPALA study intends to improve adherence to lifestyle advice by involving patients in decision making on cardiovascular prevention by nurse-led clinics. The aim of this paper is to describe the design and methods of a study to evaluate an intervention aimed at involving patients in cardiovascular risk management. METHODS: A cluster-randomised controlled trial in 20 general practices, 10 practices in the intervention arm and 10 in the control arm, starting on October 2005. A total of 720 patients without existing cardiovascular diseases but eligible for cardiovascular risk assessment will be recruited. In both arms, the general practitioners and nurses will be trained to apply the national guideline for cardiovascular risk management. Nurses in the intervention arm will receive an extended training in risk assessment, risk communication, the use of a decision aid and adapted motivational interviewing. This communication technique will be used to support the shared decision-making process about risk reduction. The intervention comprises 2 consultations and 1 follow-up telephone call. The nurses in the control arm will give usual care after the risk estimation, according to the national guideline. Primary outcome measures are self-reported adherence to lifestyle advice and drug treatment. Secondary outcome measures are the patients' perception of risk and their motivation to change their behaviour. The measurements will take place at baseline and after 12 and 52 weeks. Clinical endpoints will not be measured, but the absolute 10-year risk of cardiovascular events will be estimated for each patient from medical records at baseline and after 1 year. DISCUSSION: The combined use of risk communication, a decision aid and motivational interviewing to enhance patient involvement in decision making is an innovative aspect of the intervention. TRIAL REGISTRATION: Current Controlled Trials ISRCTN51556722.