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

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

Shared decision-making in epilepsy management.

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

Technology identity: the role of sociotechnical representations in the adoption of medical devices.

This study explored the sociotechnical influences shaping the naturally-occurring adoption and non-adoption of device technologies in the UK's National Health Service (NHS), amid increasing policy interest in this area. The study was informed by Science and Technology Studies and structuration and Actor Network Theory perspectives, drawing attention to the performative capacities of the technology alongside human agentic forces such as agendas and expectations, in the context of structural and macro conditions. Eight technologies were studied using a comparative ethnographic case study design and purposive and snowball sampling to identify relevant NHS, academic and industry participants. Data were collected between May 2009 and February 2012, included in-depth interviews, conference observations and printed and web-based documents and were analysed using constructivist grounded theory methods. The study suggests that while adoption decisions are made within the jurisdiction of healthcare organisations, they are shaped within a dynamic and fluid 'adoption space' that transcends organisational and geographic boundaries. Diverse influences from the industry, health care organisation and practice, health technology assessment and policy interact to produce 'technology identities.' Technology identities are composite and contested attributes that encompass different aspects of the technology (novelty, effectiveness, utility, risks, requirements) and that give a distinctive character to each. We argue that it is these socially constructed and contingent heuristic identities that shape the desirability, acceptability, feasibility and adoptability of each technology, a perspective that policy must acknowledge in seeking to intervene in health care technology adoption.

Shared decision making: really putting patients at the centre of healthcare.

Although many clinicians feel they already use shared decision making, research shows a perception-reality gap. A M Stiggelbout and colleagues discuss why it is important and highlight some best practices.

The quality, safety and content of telephone and face-to-face consultations: a comparative study.

INTRODUCTION: Telephone consulting is increasingly used to improve access to care and optimise resources for day-time work. However, there remains a debate about how such consultations differ from face-to-face consultations in terms of content quality and/or safety. To investigate this, a comparison of family doctors' telephone and face-to-face consultations was conducted. METHODS: 106 audio-recordings (from 19 doctors in nine practices) of telephone and face-to-face consultations, stratified at doctor level, were compared using the Roter Interaction Analysis Scale (RIAS) (content measure), the OPTION (observing patient involvement in decision making scale) and a modified scale based on the Royal College of General Practitioners (RCGP) consultation assessment instrument (measuring quality and safety). Patient satisfaction and enablement were measured using validated instruments. The Roter Interaction Analysis Scale scores were compared by multiple linear regression adjusting for covariates; other continuous measures by chi(2) and Student t tests and binary measures as odds ratios. RESULTS: Telephone consultations were shorter (4.6 vs 9.7 min, p<0.001), presented fewer problems (1.2 vs 1.8, p<0.001) and included less data gathering, counselling/advice and rapport building (all p<0.001) than face-to-face consultations. These differences remained significant when consultation length and number of problems were taken into account. Telephone consultations were judged less likely to include sufficient information to exclude important serious illnesses. Patient involvement and satisfaction outcomes were similar in both consultation types. CONCLUSION: Although telephone consultations are convenient and judged satisfactory by patients and doctors, they may compromise patient safety more than face-to-face consultations and further research is required to elucidate this. Telephone consultations may be more suited to follow-up and management of long-term conditions than for in-hours acute management.

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

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

A review of decision support technologies for amniocentesis.

BACKGROUND: There is an increasing interest in designing decision tools [decision support technologies (DSTs)] that support patients when they have to decide about health matters. The purpose of this review was to describe and evaluate existing DSTs for amniocentesis testing. METHODS: Ten medical and psychological databases were searched up to January 2008 and key authors and organizations contacted to identify DSTs for amniocentesis (published or otherwise). DSTs that described amniocentesis testing were included. RESULTS: Six DSTs met the inclusion criteria and were evaluated using the International Patient Decision Aids Standards Instrument. The evaluation suggested that most DSTs provided a satisfactory level of information on the index decision and, on the specific features of a diagnostic test; provided structured guidance in making a decision; were based on scientific evidence and disclosed the funding sources and authors' credentials. However, most DSTs failed to communicate probabilistic information, to clarify patient values and use plain language. The majority of DSTs did not use a systematic development process. Furthermore, the DSTs' evaluation often lacked scientific rigour. In most cases, neither the quality nor the effectiveness of the DST could be inferred from the evaluations. CONCLUSIONS: The review highlights variations in the development, evaluation and quality of existing DSTs for amniocentesis. We do not know what impact DSTs may have when implemented in clinical settings. Decisions in this context have high stakes and strong emotional impacts. It is important to ensure that DSTs achieve high standards.

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

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

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

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

Preferences for shared decision making in chronic pain patients compared with patients during a premedication visit.

BACKGROUND: There is some evidence that patients' outcomes improve if they are involved in shared decision making (SDM). A chronic pain clinic or premedication visit could be adequate settings for the implementation of SDM. So far, the patients' preference for involvement in decision making and their desire for information have not been tested in anesthesiological settings. METHODS: A group of chronic pain patients was compared with a group of patients in the premedication visit with respect to SDM, the desire for information and perceived involvement in care. The autonomy preference index (API, measuring preference for involvement and desire for information) and the perceived involvement in care scale (PICS, measuring patients' perception of easier involvement by doctors and information exchange) were administered. RESULTS: In total, 190 chronic pain patients and 151 patients of premedication were included in this study. Patient of the premedication visit had significantly higher SDM scores. Desire for information was high, but there were no differences between groups. Younger patients [B (estimate) =- 0.3; 95% CI (-0.4) - (-0.1)], women (B = 10.9; 95% CI 6.3-15.4) and patients with higher educational level (B = 10.1; 95% CI 5.6-14.6) had more desire for SDM. PICS scores were basically influenced by groups: chronic pain patients felt more facilitated by doctors [B =- 0.185; 95% CI (-0.4) - (-0.1)] and had more information exchange [B =- 19.5; 95% CI (-15.8) - (-2.4)] than patients in the premedication visit. CONCLUSION: In both anesthesiological settings, the desire for information was high, but patients in the premedication visit had higher SDM scores, especially young female patients with higher educational level. Real patient-physician interaction showed that premedication patients felt less involved by doctors and had less information exchange compared with the chronic pain patients. Therefore, premedication visits should be focussed more on adequate information exchange and involvement of the patient in the shared decision making process.

Are patients morally responsible for their errors?

Amid neglect of patients' contribution to error has been a failure to ask whether patients are morally responsible for their errors. This paper aims to help answer this question and so define a worthy response to the errors. Recent work on medical errors has emphasised system deficiencies and discouraged finding people to blame. We scrutinize this approach from an incompatibilist, agent causation position and draw on Hart's taxonomy of four senses of moral responsibility: role responsibility; capacity responsibility; causal responsibility; and liability responsibility. Each sense is shown to contribute to an overall theoretical judgment as to whether patients are morally responsible for their errors (and success in avoiding them). Though how to weight the senses is unclear, patients appear to be morally responsible for the avoidable errors they make, contribute to or can influence.

"Of the edgelands": broadening the scope of qualitative methodology.

In an editorial in a previous issue of this journal Rapport et al introduced the metaphor of the edgelands, arguing that the area between urban and rural landscapes serves to illustrate some of the difficulties of interdisciplinarity experienced by those who work in the medical humanities. In this paper the authors explore some specific issues of qualitative research methodology in health care research. The paper describes a broadening out of the scope of qualitative inquiry in social scientific research in health and social care. The paper explains why some new methodologies have emerged and how both old and new methodologies are grouped around three interlocking strands: narrative based, arts based, and redefined, methodology. In order to illustrate developments in this field, the authors present three examples of the use of these methodologies in practice: photo elicitation technique; discourse analytic, and interpretive anthropological, method. Finally the authors illustrate how these methodologies can give added value to health services research.

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

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

Achieving involvement: process outcomes from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice.

BACKGROUND: A consulting method known as 'shared decision making' (SDM) has been described and operationalized in terms of several 'competences'. One of these competences concerns the discussion of the risks and benefits of treatment or care options-'risk communication'. Few data exist on clinicians' ability to acquire skills and implement the competences of SDM or risk communication in consultations with patients. OBJECTIVE: The aims of this study were to evaluate the effects of skill development workshops for SDM and the use of risk communication aids on the process of consultations. METHODS: A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. Half the consultations were randomly selected for audio-taping, of which 352 patients attended and were audio-taped successfully. After baseline, participating doctors were randomized to receive training in (i) SDM skills or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were allocated randomly to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations were audio-taped from each phase. Raters (independent, trained and blinded to study phase) assessed the audio-tapes using a validated scale to assess levels of patient involvement (OPTION: observing patient involvement), and to analyse the nature of risk information discussed. Clinicians completed questionnaires after each consultation, assessing perceived clinician-patient agreement and level of patient involvement in decisions. Multilevel modelling was carried out with the OPTION score as the dependent variable, and rater, consultation and clinician levels of data, standardized by rater within clinician. RESULTS: Following each of the interventions, the clinicians significantly increased their involvement of patients in decision making (OPTION score increased by 10.6 following risk communication training [95% confidence interval (CI) 7.9 -13.3; P < 0.001] and by 12.9 after SDM skill development (95% CI 10 -15.8, P < 0.001), a moderate effect size. The level of involvement achieved by the risk communication aids was significantly increased by the subsequent introduction of the skill development workshops (7.7 increase in OPTION score, 95% CI 3.4-12; P < 0.001). The alternative sequence (skills followed by risk communication aids) did not achieve this effect. The use of most risk information formats increased after the provision of specific risk communication aids (P < 0.001). Clinicians using the risk communication tools perceived significantly higher patient and clinician agreement on treatment (P < 0.001), patient satisfaction with information (P < 0.01), clinician satisfaction with decision (P < 0.01) and general overall satisfaction with the consultation (P < 0.001) than those who were exposed to SDM skill development workshops. CONCLUSIONS: These clinicians were able to acquire the skills to implement SDM competences and to use risk communication aids. Each intervention provided independent effects. Further progress towards greater patient involvement in health care decision making is possible, and skill development in this area should be incorporated into postgraduate professional development programmes.

Patient-based outcome results from a cluster randomized trial of shared decision making skill development and use of risk communication aids in general practice.

BACKGROUND: Shared decision-making (SDM) between professionals and patients is increasingly advocated from ethical principles. Some data are accruing about the effects of such approaches on health or other patient-based outcomes. These effects often vary substantially between studies. OBJECTIVE: Our aim was to evaluate the effects of training GPs in SDM, and the use of simple risk communication aids in general practice, on patient-based outcomes. METHODS: A cluster randomized trial with crossover was carried out with the participation of 20 recently qualified GPs in urban and rural general practices in Gwent, South Wales. A total of 747 patients with known atrial fibrillation, prostatism, menorrhagia or menopausal symptoms were invited to a consultation to review their condition or treatments. After baseline, participating doctors were randomized to receive training in (i) SDM skills; or (ii) the use of simple risk communication aids, using simulated patients. The alternative training was then provided for the final study phase. Patients were randomly allocated to a consultation during baseline or intervention 1 (SDM or risk communication aids) or intervention 2 phases. A randomly selected half of the consultations took place in 'research clinics' to evaluate the effects of more time for consultations, compared with usual surgery time. Patient-based outcomes were assessed at exit from consultation and 1 month follow-up. These were: COMRADE instrument (principal measures; subscales of risk communication and confidence in decision), and a range of secondary measures (anxiety, patient enablement, intention to adhere to chosen treatment, satisfaction with decision, support in decision making and SF-12 health status measure). Multilevel modelling was carried out with outcome score as the dependent variable, and follow-up point (i.e. exit or 1 month later for each patient), patient and doctor levels of explanatory variables. RESULTS: No statistically significant changes in patient-based outcomes due to the training interventions were found: COMRADE risk communication score increased 0.7 [95% confidence interval (CI) -0.92 to 2.32] after risk communication training and 0.9 (95% CI -0.89 to 2.35) after SDM training; and COMRADE satisfaction with communication score increased by 1.0 (95% CI -1.1 to 3.1) after risk communication, and decreased by 0.6 (95% CI 2.7 to -1.5) after SDM training. Patients' confidence in the decision (2.1 increase, 95% CI 0.7-3.5, P < 0.01) and expectation to adhere to chosen treatments (0.7 increase, 95% CI 0.04-1.36, P < 0.05) were significantly greater among patients seen in the research clinics (when more time was available) compared with usual surgery time. Most outcomes deteriorated between exit and 1 month later. There was no interaction between intervention effects. CONCLUSION: Patients can be more involved in treatment decisions, and risks and benefits of treatment options can be explained in more detail, without adversely affecting patient-based outcomes. SDM and risk communication may be advocated from values and ethical principles even without evidence of health gain or improvement in patient-based outcomes, but the resources required to enhance these professional skills must also be taken into consideration. These data also indicate the benefits of extra consultation time.

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

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