Vikki Entwistle

Developing a quality criteria framework for patient decision aids: online international Delphi consensus process

Abstract 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.

Decision aids for patients facing health treatment or screening decisions: systematic review

Abstract Objective: To conduct a systematic review of randomised trials of patient decision aids in improving decision making and outcomes. Design: We included randomised trials of interventions providing structured, detailed, and specific information on treatment or screening options and outcomes to aid decision making. Two reviewers independently screened and extracted data on several evaluation criteria. Results were pooled by using weighted mean differences and relative risks. Results: 17 studies met the inclusion criteria. Compared with the controls, decision aids produced higher knowledge scores (weighted mean difference=19/100, 95% confidence interval 14 to 25); lower decisional conflict scores (weighted mean difference=−0.3/5, −0.4 to −0.1); more active patient participation in decision making (relative risk = 2.27, 95% confidence interval 1.3 to 4); and no differences in anxiety, satisfaction with decisions (weighted mean difference=0.6/100, −3 to 4), or satisfaction with the decision making process (2/100,−3 to 7). Decision aids had a variable effect on decisions. When complex decision aids were compared with simpler versions, they were better at reducing decisional conflict, improved knowledge marginally, but did not affect satisfaction. Conclusions: Decision aids improve knowledge, reduce decisional conflict, and stimulate patients to be more active in decision making without increasing their anxiety. Decision aids have little effect on satisfaction and a variable effect on decisions. The effects on outcomes of decisions (persistence with choice, quality of life) remain uncertain.

What is an adequate sample size? Operationalising data saturation for theory-based interview studies

In interview studies, sample size is often justified by interviewing participants until reaching ‘data saturation’. However, there is no agreed method of establishing this. We propose principles for deciding saturation in theory-based interview studies (where conceptual categories are pre-established by existing theory). First, specify a minimum sample size for initial analysis (initial analysis sample). Second, specify how many more interviews will be conducted without new ideas emerging (stopping criterion). We demonstrate these principles in two studies, based on the theory of planned behaviour, designed to identify three belief categories (Behavioural, Normative and Control), using an initial analysis sample of 10 and stopping criterion of 3. Study 1 (retrospective analysis of existing data) identified 84 shared beliefs of 14 general medical practitioners about managing patients with sore throat without prescribing antibiotics. The criterion for saturation was achieved for Normative beliefs but not for other beliefs or studywise saturation. In Study 2 (prospective analysis), 17 relatives of people with Pagets disease of the bone reported 44 shared beliefs about taking genetic testing. Studywise data saturation was achieved at interview 17. We propose specification of these principles for reporting data saturation in theory-based interview studies. The principles may be adaptable for other types of studies.

What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

BackgroundA commonly reported problem with the conduct of multicentre randomised controlled trials (RCTs) is that recruitment is often slower or more difficult than expected, with many trials failing to reach their planned sample size within the timescale and funding originally envisaged. The aim of this study was to explore factors that may have been associated with good and poor recruitment in a cohort of multicentre trials funded by two public bodies: the UK Medical Research Council (MRC) and the Health Technology Assessment (HTA) Programme.MethodsThe cohort of trials was identified from the administrative databases held by the two funding bodies. 114 trials that recruited participants between 1994 and 2002 met the inclusion criteria. The full scientific applications and subsequent trial reports submitted by the trial teams to the funders provided the principal data sources. Associations between trial characteristics and recruitment success were tested using the Chi-squared test, or Fishers exact test where appropriate.ResultsLess than a third (31%) of the trials achieved their original recruitment target and half (53%) were awarded an extension. The proportion achieving targets did not appear to improve over time. The overall start to recruitment was delayed in 47 (41%) trials and early recruitment problems were identified in 77 (63%) trials. The inter-relationship between trial features and recruitment success was complex. A variety of strategies were employed to try to increase recruitment, but their success could not be assessed.ConclusionRecruitment problems are complex and challenging. Many of the trials in the cohort experienced recruitment difficulties. Trials often required extended recruitment periods (sometimes supported by additional funds). While this is of continuing concern, success in addressing the trial question may be more important than recruitment alone.

Lay perspectives: advantages for health research

Although involvement of the consumer is increasingly being advocated in health related research, it is not welcome universally. Furthermore, the underlying rationale is rarely made explicit. Policy makers, health care professionals, and researchers need to be clear about the benefits and ways of including lay perspectives and the criteria for evaluating these. Examples of lay involvement in setting research agendas,1 2 3 4 methodological debate,5 and specific projects4 6 4 are accumulating, but little clear evidence about the benefits and costs of different ways of incorporating lay input into health services research is available. We outline two basic reasons for incorporating lay perspectives into research and discuss some common objections. A framework is offered to help clarify the dimensions of lay involvement in health research. We use the term “lay” to mean people who are neither health care professionals nor health services researchers, but who may have specialised knowledge related to health. This includes patients, the general public, and consumer advocates. The current interest in incorporating lay perspectives into health services research reflects broad social and political trends and developments in health care that have involved some breaching of the boundaries between medical professionals and others. The assumptions that the “experts”–doctors and biomedical researchers—are the best judges of what research is needed and should be exempt from democratic accountability are questioned. In addition, theoretical and empirical work on the philosophy and sociology of science has shown that the culture and values of those involved can influence research and the knowledge derived from it.8 The relevance of much research that has been driven by narrow professional and academic interests is increasingly being questioned.9 10 ![][1] #### Summary points Including lay people in health services research has been mandated politically and could improve the quality and impact of research Patients and … [1]: /embed/graphic-1.gif

Do Patient Decision Aids Meet Effectiveness Criteria of the International Patient Decision Aid Standards Collaboration? A Systematic Review and Meta-analysis

Objective. To describe the extent to which patient decision aids (PtDAs) meet effectiveness standards of the International Patient Decision Aids Collaboration (IPDAS). Data sources. Five electronic databases (to July 2006) and personal contacts (to December 2006). Results. Among 55 randomized controlled trials, 38 (69%) used at least 1 measure that mapped onto an IPDAS effectiveness criterion. Measures of decision quality were knowledge scores (27 trials), accurate risk perceptions (12 trials), and value congruence with the chosen option (3 trials). PtDAs improved knowledge scores relative to usual care (weighted mean difference [WMD] = 15.2%, 95% confidence interval [CI] = 11.7 to 18.7); detailed PtDAs were somewhat more effective than simpler PtDAs (WMD = 4.6%, 95% CI = 3.0 to 6.2). PtDAs with probabilities improved accurate risk perceptions relative to those without probabilities (relative risk = 1.6, 95% CI = 1.4 to 1.9). Relative to simpler PtDAs, detailed PtDAs improved value congruence with the chosen option. Only 2 of 6 IPDAS decision process criteria were measured: feeling informed (15 trials) and feeling clear about values (13 trials). PtDAs improved these process measures relative to usual care (feeling uninformed WMD = —8.4, 95% CI = —11.9 to —4.8; unclear values WMD = —6.3, 95% CI = —10.0 to —2.7). There was no difference in process measures when detailed and simple PtDAs were compared. Conclusions. PtDAs improve decision quality and the decision processs measures of feeling informed and clear about values; however, the size of the effect varies across studies. Several IPDAS decision process measures have not been used. Future trials need to use a minimum data set of IPDAS evaluation measures. The degree of detail PtDAs require for positive effects on IPDAS criteria should be explored.

Supporting Patient Autonomy: The Importance of Clinician-patient Relationships

Personal autonomy is widely valued. Recognition of its vulnerability in health care contexts led to the inclusion of respect for autonomy as a key concern in biomedical ethics. The principle of respect for autonomy is usually associated with allowing or enabling patients to make their own decisions about which health care interventions they will or will not receive. In this paper, we suggest that a strong focus on decision situations is problematic, especially when combined with a tendency to stress the importance of patients’ independence in choosing. It distracts attention from other important aspects of and challenges to autonomy in health care. Relational understandings of autonomy attempt to explain both the positive and negative implications of social relationships for individuals’ autonomy. They suggest that many health care practices can affect autonomy by virtue of their effects not only on patients’ treatment preferences and choices, but also on their self-identities, self-evaluations and capabilities for autonomy. Relational understandings de-emphasise independence and facilitate well-nuanced distinctions between forms of clinical communication that support and that undermine patients’ autonomy. These understandings support recognition of the value of good patient-professional relationships and can enrich the specification of the principle of respect for autonomy.

Evidence-Informed Patient Choice: Practical Issues of Involving Patients in Decisions About Health Care Technologies

Evidence-informed patient choice involves providing people with research-based information about the effectiveness of health care options and promoting their involvement in decisions about their treatment. Although the concept seems desirable, the processes and outcomes of evidence-informed patient choice are poorly understood, and it should be carefully evaluated.

A systematic review of the effectiveness of health service interventions aimed at reducing inequalities in health.

Objective: To review the available evidence in order to identify effective interventions which health services alone or in collaboration with other agencies could use to reduce inequalities in health. Methods: A search of the literature was undertaken using a number of databases including Medlin (from 1990), Applied Social Science Index and Abstracts (1987–1994), and the System for Information on Grey Literature in Europe (1984–1994), on a large range of key words. Studies were included if they assessed interventions designed to reduce inequalities in health or improve the health of a population group relevant to the review, and could be carried out by a health service alone or in collaboration with other agencies. Only studies evaluating interventions using an experimental design were included. Papers in any language were considered. In addition, systematic reviews of the research on the effectiveness of health promotion and the treatment of conditions where there are significant health inequalities were identified in order to illustrate the potential for reducing inequalities in health. Results: 94 studies were identified which satisfied all the inclusion criteria and 21 reviews were included. A number of interventions have been shown to improve the health of groups who are disadvantaged by socio-economic class, ethnicity or age and, if properly targeted, could be expected to reduce health inequalities. If a health intervention is being used, there should be evidence that it has an impact on health status. Attention should then be given to the way in which the intervention is delivered and the characteristics of a programme to promote implementation. Characteristics of successful interventions specifically aimed at reducing health differentials include: Systematic and intensive approaches to delivering effective health care; improvement in access and prompts to encourage the use of services; strategies employing a combination of interventions and those involving a multi-disciplinary approach; ensuring interventions address the expressed or identified needs of the target population; and the involvement of peers in the delivery of interventions. However, these characteristics alone are not sufficient for success, nor are they universally necessary. Conclusions: Although it is likely that the most significant contributions to reducing health inequalities will be in improving economic and social conditions and the physical environment, there are interventions which health services, either alone or in collaboration with other agencies, can use to reduce inequalities in health.

Treating patients as persons: a capabilities approach to support delivery of person-centered care.

Health services internationally struggle to ensure health care is “person-centered” (or similar). In part, this is because there are many interpretations of “person-centered care” (and near synonyms), some of which seem unrealistic for some patients or situations and obscure the intrinsic value of patients’ experiences of health care delivery. The general concern behind calls for person-centered care is an ethical one: Patients should be “treated as persons.” We made novel use of insights from the capabilities approach to characterize person-centered care as care that recognizes and cultivates the capabilities associated with the concept of persons. This characterization unifies key features from previous characterisations and can render person-centered care applicable to diverse patients and situations. By tying person-centered care to intrinsically valuable capability outcomes, it incorporates a requirement for responsiveness to individuals and explains why person-centered care is required independently of any contribution it may make to health gain.