Making a decision about trial participation : the feasibility of measuring deliberation during the informed consent process for clinical trials

Peer reviewedPublisher PD

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

Measurement Challenges in Shared Decision Making: Putting the ‘Patient’ in Patient‐Reported Measures

Measuring clinicians\u27 shared decision-making (SDM) performance is a key requirement given the intensity of policy interest in many developed countries - yet it remains one of the most difficult methodological challenges, which is a concern for many stakeholders. In this Viewpoint Article, we investigate the development of existing patient-reported measures (PRMs) of SDM identified in a recent review. We find that patients were involved in the development of only four of the 13 measures. This lack of patient involvement in PRM development is associated with two major threats to content validity, common to all 13 PRMs of SDM: (i) an assumption of patient awareness of \u27decision points\u27 and (ii) an assumption that there is only one decision point in each healthcare consultation. We provide detailed examples of these threats and their impact on accurate assessment of SDM processes and outcomes, which may hamper efforts to introduce incentives for SDM implementation. We propose cognitive interviewing as a recommended method of involving patients in the design of PRMs in the field of SDM and provide a practical example of this approach

Measurement Challenges in Shared Decision Making: Putting the ‘Patient’ in Patient‐Reported Measures

Measuring clinicians\u27 shared decision-making (SDM) performance is a key requirement given the intensity of policy interest in many developed countries - yet it remains one of the most difficult methodological challenges, which is a concern for many stakeholders. In this Viewpoint Article, we investigate the development of existing patient-reported measures (PRMs) of SDM identified in a recent review. We find that patients were involved in the development of only four of the 13 measures. This lack of patient involvement in PRM development is associated with two major threats to content validity, common to all 13 PRMs of SDM: (i) an assumption of patient awareness of \u27decision points\u27 and (ii) an assumption that there is only one decision point in each healthcare consultation. We provide detailed examples of these threats and their impact on accurate assessment of SDM processes and outcomes, which may hamper efforts to introduce incentives for SDM implementation. We propose cognitive interviewing as a recommended method of involving patients in the design of PRMs in the field of SDM and provide a practical example of this approach

The Two-Week Rule for NHS Gastrointestinal Cancer Referrals: A Systematic Review of Diagnostic Effectiveness

Aim: To systematically review the impact of the Two-Week Rule in increasing the pick-up rate of colorectal cancers and Upper Gastrointestinal (GI) cancers in the NHS.Materials and Methods: Data were combined for meta-analyses to determine (1) the Two-Week Rule pick-up rate for each cancer type and (2) the proportion of patients referred using the Two-Week Rule. Overall results were given as weighted averages.Results: There were 20 articles and 27 peer-reviewed abstracts included in this review. Colorectal Cancer: Only 9.5% of patients referred by the Two-Week Rule were eventually diagnosed with colorectal cancer (n = 24). When examining the referral origin of all colorectal cancer patients diagnosed during the time of 19 studies with this data, 32.2% had been referred using the Two-Week Rule. Upper GI Cancer: Only 5.5% of patients referred by the Two-Week Rule were eventually diagnosed with Upper GI cancer (n = 23). When examining the referral origin of all Upper GI cancer patients diagnosed during the time of 17 studies with this data, 23.6% had been referred using the Two-Week Rule.Conclusion: The Two-Week Rule is not sufficiently effective in diagnosing neither upper GI nor colorectal cancers in patients presenting to their General Practitioner

Pathways and prospects in cancer research: Securing futures and negotiating boundaries

This paper draws on literature from the sociology of expectations to explore accounts of experts in cancer research and clinical practice. The cancer specialists’ accounts presented in this article are taken from interviews undertaken as part of a project that aimed to develop a research agenda for the next ten to thirty years that will achieve early detection and prevention in the four main cancers: (i) bowel and colorectal, (ii) prostate, (iii) lung and (iv) breast. Drawing on secondary analysis of the interviews, this article provides a sociological exploration of both the experts’ versions of the future and the interactions between the interviewer and research participant to show expectation in the making: the competing stories of what is and what ought to be the focus of cancer research now and in the (near) future. The building of a cancer research agenda is shown to be a contested future, represented by a dominant and resistant view of the cancer problem, in which cancer specialists must engage in performative strategies and boundary work to frame the present problem: what cancer is and how it can be detected and, subsequently, to claim credibility for a future pathway

An independent evaluation of the modernization of NHS endoscopy services in England: data poverty and no improvement

Rationale, aims and objectives The Modernising Endoscopy Services (MES) programme introduced a focussed modernization drive and data collection regime to English NHS endoscopy services. We independently evaluated the MES programme by comparing routinely collected, service-related endoscopy data from sites that participated in the MES programme and sites that did not. Methods A random selection of 10 endoscopy units who had participated in the MES programme (intervention sites) were compared with a random selection of 10 endoscopy units who redesigned their services independently (control sites). Data on demand, numbers waiting, activity and cancellations were collected for eight time points between January 2003 and April 2006. Data were aggregated into intervention and control groups for statistical analysis using a two-way analysis of variance. Activity data were validated using an equivalent Hospital Episode Statistics dataset. Results Data were not routinely collected by 11 of 19 endoscopy units. Trust-held datasets were subsequently included to address problems with data availability. The accuracy of the Activity data was successfully validated. Statistical analysis of the data showed that neither the intervention group nor the control group were able to significantly improve their services over time. There was also no significant difference between the intervention group and the control group in the improvement of their endoscopy services at any point time. Conclusions Based on the data collected, the intervention programme did not significantly improve NHS endoscopy services in England over and above what could have been achieved independently with only the intention to redesign

Implementing Shared Decision-Making: Consider All the Consequences

The ethical argument that shared decision-making is “the right” thing to do, however laudable, is unlikely to change how healthcare is organized, just as evidence alone will be an insufficient factor: practice change is governed by factors such as cost, profit margin, quality, and efficiency. It is helpful, therefore, when evaluating new approaches such as shared decision-making to conceptualize potential consequences in a way that is broad, long-term, and as relevant as possible to multiple stakeholders. Yet, so far, evaluation metrics for shared decision-making have been mostly focused on short-term outcomes, such as cognitive or affective consequences in patients. The goal of this article is to hypothesize a wider set of consequences, that apply over an extended time horizon, and include outcomes at interactional, team, organizational and system levels, and to call for future research to study these possible consequences

Working with interpreters: the challenges of introducing Option Grid patient decision aids

Objective We aimed to observe how an Option GridTM decision aid for clinical encounters might be used where an interpreter is present, and to assess the impact of its use on shared decision making. Methods Data were available from three clinical consultations between patient, clinician (a physiotherapist), and interpreter about knee osteoarthritis. Clinicians were trained in the use of an Option Grid decision aid and the tool was used. Consultations were audio-recorded, transcribed, and translated by independent translators into English. Results Analysis revealed the difficulties with introducing a written decision aid into an interpreted consultation. The extra discussion needed between the clinician and interpreter around the principles and purpose of shared decision making and instructions regarding the Option Grid decision aid proved challenging and difficult to manage. Discussion of treatment options while using an Option Grid decision aid was predominantly done between clinician and interpreter. The patient appeared to have little involvement in discussion of treatment options. Conclusion Patients were not active participants within the discussion. Further work needs to be done on how shared decision making can be achieved within interpreted consultations. Practice Implications Option Grid decision aids are not being used as intended in interpreted consultations

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