The "unknown territory" of goal-setting: Negotiating a novel interactional activity within primary care doctor-patient consultations for patients with multiple chronic conditions.

Goal-setting is widely recommended for supporting patients with multiple long-term conditions. It involves a proactive approach to a clinical consultation, requiring doctors and patients to work together to identify patient's priorities, values and desired outcomes as a basis for setting goals for the patient to work towards. Importantly it comprises a set of activities that, for many doctors and patients, represents a distinct departure from a conventional consultation, including goal elicitation, goal-setting and action planning. This indicates that goal-setting is an uncertain interactional space subject to inequalities in understanding and expectations about what type of conversation is taking place, the roles of patient and doctor, and how patient priorities may be configured as goals. Analysing such spaces therefore has the potential for revealing how the principles of goal-setting are realised in practice. In this paper, we draw on Goffman's concept of 'frames' to present an examination of how doctors' and patients' sense making of goal-setting was consequential for the interactions that followed. Informed by Interactional Sociolinguistics, we used conversation analysis methods to analyse 22 video-recorded goal-setting consultations with patients with multiple long-term conditions. Data were collected between 2016 and 2018 in three UK general practices as part of a feasibility study. We analysed verbal and non-verbal actions for evidence of GP and patient framings of consultation activities and how this was consequential for setting goals. We identified three interactional patterns: GPs checking and reframing patients' understanding of the goal-setting consultation, GPs actively aligning with patients' framing of their goal, and patients passively and actively resisting GP framing of the patient goals. These reframing practices provided "telling cases" of goal-setting interactions, where doctors and patients need to negotiate each other's perspectives but also conflicting discourses of patient-centredness, population-based evidence for treating different chronic illnesses and conventional doctor-patient relations.

The politics of ageing: health consumers, markets and hegemonic challenge.

In recent years ageing has travelled from the placid backwaters of politics into the mainstream of economic, social and cultural debate. What are the forces that have politicised ageing, creating a sustained opposition to the supply side hegemony of pharmaceuticals, medicine and state which has historically constructed, propagated and legitimised the understanding of ageing as decline in social worth? In addressing this question, the paper develops Gramsci's theory of hegemony to include the potentially disruptive demand side power of consumers and markets. It shows how in the case of ageing individuals acting in concert through the mechanisms of the market, and not institutionalised modes of opposition, may become the agents of hegemonic challenge through a combination of lifecourse choice and electoral leverage. In response, the hegemony is adapting through the promotion of professionally defined interpretations of 'active ageing' designed to retain hegemonic control. With the forces of hegemony and counter-hegemony nicely balanced and fresh issues such as intergenerational justice constantly emerging, the political tensions of ageing are set to continue.

A systematic review of the physical activity assessment tools used in primary care.

Background: Primary care is an ideal setting for physical activity interventions to prevent and manage common long-term conditions. To identify those who can benefit from such interventions and to deliver tailored support, primary care professionals (e.g. GPs, practice nurses, physiotherapists, health care assistants) need reliable and valid tools to assess physical activity. However, there is uncertainty about the best-performing tool. Objective: To identify the tools used in the literature to assess the physical activity in primary care and describe their psychometric properties. Method: A systematic review of published and unpublished literature was undertaken up to 1 December 2016). Papers detailing physical activity measures, tools or approaches used in primary care consultations were included. A synthesis of the frequency and context of their use, and their psychometric properties, was undertaken. Studies were appraised using the Downs and Black critical appraisal tool and the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) initiative checklist. Results: Fourteen papers reported 10 physical activity assessment tools. The General Practice Physical Activity Questionnaire (GPPAQ) was most frequently reported. None of the assessment tools identified showed high reliability and validity. Intra-rater reliability ranged from kappa: 0.53 [Brief Physical Activity Assessment Tool (BPAAT)] to 0.67 (GPPAQ). Criterion validity ranged from Pearson's rho: 0.26 (GPPAQ) to 0.52 (Physical Activity Vital Sign). Concurrent validity ranged from kappa: 0.24 (GPPAQ) to 0.64 (BPAAT). Conclusion: The evidence base about physical activity assessment in primary care is insufficient to inform current practice.

Methodological review: quality of randomized controlled trials in health literacy.

BACKGROUND: The growing move towards patient-centred care has led to substantial research into improving the health literacy skills of patients and members of the public. Hence, there is a pressing need to assess the methodology used in contemporary randomized controlled trials (RCTs) of interventions directed at health literacy, in particular the quality (risk of bias), and the types of outcomes reported. METHODS: We conducted a systematic database search for RCTs involving interventions directed at health literacy in adults, published from 2009 to 2014. The Cochrane Risk of Bias tool was used to assess quality of RCT implementation. We also checked the sample size calculation for primary outcomes. Reported evidence of efficacy (statistical significance) was extracted for intervention outcomes in any of three domains of effect: knowledge, behaviour, health status. Demographics of intervention participants were also extracted, including socioeconomic status. RESULTS: We found areas of methodological strength (good randomization and allocation concealment), but areas of weakness regarding blinding of participants, people delivering the intervention and outcomes assessors. Substantial attrition (losses by monitoring time point) was seen in a third of RCTs, potentially leading to insufficient power to obtain precise estimates of intervention effect on primary outcomes. Most RCTs showed that the health literacy interventions had some beneficial effect on knowledge outcomes, but this was typically for less than 3 months after intervention end. There were far fewer reports of significant improvements in substantive patient-oriented outcomes, such as beneficial effects on behavioural change or health (clinical) status. Most RCTs featured participants from vulnerable populations. CONCLUSIONS: Our evaluation shows that health literacy trial design, conduct and reporting could be considerably improved, particularly by reducing attrition and obtaining longer follow-up. More meaningful RCTs would also result if health literacy trials were designed with public and patient involvement to focus on clinically important patient-oriented outcomes, rather than just knowledge, behaviour or skills in isolation.

The feasibility of determining the effectiveness and cost-effectiveness of medication organisation devices compared with usual care for older people in a community setting: systematic review, stakeholder focus groups and feasibility randomised controlled trial.

BACKGROUND: Medication organisation devices (MODs) provide compartments for a patient's medication to be organised into the days of the week and the recommended times the medication should be taken. AIM: To define the optimal trial design for testing the clinical effectiveness and cost-effectiveness of MODs. DESIGN: The feasibility study comprised a systematic review and focus groups to inform a randomised controlled trial (RCT) design. The resulting features were tested on a small scale, using a 2 × 2 factorial design to compare MODs with usual packaging and to compare weekly with monthly supply. The study design was then evaluated. SETTING: Potential participants were identified by medical practices. PARTICIPANTS: Aged over 75 years, prescribed at least three solid oral dosage form medications, unintentionally non-adherent and self-medicating. Participants were excluded if deemed by their health-care team to be unsuitable. INTERVENTIONS: One of three MODs widely used in routine clinical practice supplied either weekly or monthly. OBJECTIVES: To identify the most effective method of participant recruitment, to estimate the prevalence of intentional and unintentional non-adherence in an older population, to provide a point estimate of the effect size of MODs relative to usual care and to determine the feasibility and acceptability of trial participation. METHODS: The systematic review included MOD studies of any design reporting medication adherence, health and social outcomes, resource utilisation or dispensing or administration errors. Focus groups with patients, carers and health-care professionals supplemented the systematic review to inform the RCT design. The resulting design was implemented and then evaluated through questionnaires and group discussions with participants and health-care professionals involved in trial delivery. RESULTS: Studies on MODs are largely of poor quality. The relationship between adherence and health outcomes is unclear. Of the limited studies reporting health outcomes, some reported a positive relationship while some reported increased hospitalisations associated with MODs. The pre-trial focus groups endorsed the planned study design, but suggested a minimum recruitment age of 50-60 years. A total of 35.4% of patients completing the baseline questionnaire were excluded because they already used a MOD. Active recruitment yielded a higher consent rate, but passive recruitment was more cost-effective. The prevalence of intentional non-adherence was 24.7% [n = 71, 95% confidence interval (CI) 19.7% to 29.6%] of participants. Of the remaining 76 participants, 46.1% (95% CI 34.8% to 57.3%) were unintentionally non-adherent. There was no indication of a difference in adherence between the study arms. Participants reported a high level of satisfaction with the design. Five adverse/serious adverse events were identified in the MOD study arms and none was identified in the control arms. There was no discernible difference in health economic outcomes between the four study arms; the mean intervention cost was £20 per month greater for MOD monthly relative to usual supply monthly. CONCLUSIONS: MOD provision to unintentionally non-adherent older people may cause medication-related adverse events. The primary outcome for a definitive MOD trial should be health outcomes. Such a trial should recruit patients by postal invitation and recruit younger patients. FUTURE WORK: A study examining the association between MOD initiation and adverse effects is necessary and a strategy to safely introduce MODs should be explored. A definitive study testing the clinical effectiveness and cost-effectiveness of MODs is also required. STUDY REGISTRATION: Current Controlled Trials ISRCTN 30626972 and UKCRN 12739. FUNDING: This project was funded by National Institute for Health Research (NIHR) Health Technology Assessment Programme and will be published in full in Health Technology Assessment; Vol. 20, No. 50. See the NIHR Journals Library website for further project information.

Bioethical ambition, political opportunity and the European governance of patenting: the case of human embryonic stem cell science.

Scientific progress in the life sciences is dependent on the governance of tensions between the economic potential of the innovation and the cultural response from society. Ownership of the scientific innovation through patenting is a necessary part of the realization of its economic value yet, in the case of human embryonic stem cell (hESC) science, ownership of the human body and human life may offend fundamental cultural values. In the case of transnational patenting governance by the European Patent Office (EPO) and the European Union (EU), cross-national cultural conflict in the field of hESC science has produced a political demand for a form of governance that can incorporate ethical as well as economic judgements in its decision making. This paper explores how bioethics has responded to this opportunity to establish itself as a form of expert authority for the negotiation and resolution of the cultural conflict. In so doing, it shows how the political struggle that has accompanied this bid for new governance territory has been influenced both by the political tensions between the EPO and EU systems of patenting governance and the resistance of competing experts in law and science to a bioethical presence.