The Baby Box scheme in Scotland: A study of public attitudes and social value.

BACKGROUND: The Scottish Government introduced a free Baby Box scheme for all new parents in 2017, modelled on the Finnish scheme, to give every baby 'an equal start in life'. There is little evidence that it results in better health outcomes, but there has been limited research into different perspectives and discourses on such schemes. METHODS: Four focus groups were conducted with 21 parents in North-East Scotland. Recordings were transcribed verbatim, anonymized and analysed thematically with NVivo 12 software. Our thematic analysis was both inductive and deductive-remaining open to themes identified by participants themselves but also informed by the social policy literature on universalism and social cohesion. RESULTS: Across all the focus groups, we found a high degree of positivity about the principle of the Baby Box scheme, and for the most part the practical value of the contents. This was remarkably consistent across different communities and backgrounds. There was little evidence of the strongly polarized views present in media reporting. Parents seemed considerably less focused than the media on safety and health outcomes, and more focused on practical, material and social impacts. They reported little in the way of feeling patronized or monitored by the government. CONCLUSION: Our findings have important implications for future economic evaluations of the baby box. Such evaluations should broaden the valuation space beyond health outcomes to allow for the value of feelings of inclusion, solidarity and being part of a community. PATIENT OR PUBLIC CONTRIBUTION: This small project was designed in response to parent views already collected in the early roll-out of the Baby Box scheme in Scotland, about their priorities and responses to the scheme. Additional views were sought on the topic guide for the focus groups, and local community groups advised us on recruitment and the best timing and location for the focus groups to be held. The focus groups themselves were conducted as research, but with the intent of ensuring parent views featured more prominently in a debate that has been largely dominated by clinical and public health perspectives.

We need to talk about purpose: a critical interpretive synthesis of health and social care professionals' approaches to self-management support for people with long-term conditions.

BACKGROUND: Health policies internationally advocate 'support for self-management', but it is not clear how the promise of the concept can be fulfilled. OBJECTIVE: To synthesize research into professional practitioners' perspectives, practices and experiences to help inform a reconceptualization of support for self-management. DESIGN: Critical interpretive synthesis using systematic searches of literature published 2000-2014. FINDINGS: We summarized key insights from 164 relevant papers in an annotated bibliography. The literature illustrates striking variations in approaches to support for self-management and interpretations of associated concepts. We focused particularly on the somewhat neglected question of the purpose of support. We suggest that this can illuminate and explain important differences between narrower and broader approaches. Narrower approaches support people to manage their condition(s) well in terms of disease control. This purpose can underpin more hierarchical practitioner-patient communication and more limited views of patient empowerment. It is often associated with experiences of failure and frustration. Broader approaches support people to manage well with their condition(s). They can keep work on disease control in perspective as attention focuses on what matters to people and how they can be supported to shape their own lives. Broader approaches are currently less evident in practice. DISCUSSION AND CONCLUSION: Broader approaches seem necessary to fulfil the promise of support for self-management, especially for patient empowerment. A commitment to enable people to live well with long-term conditions could provide a coherent basis for the forms and outcomes of support that policies aspire to. The implications of such a commitment need further attention.

"Was that a success or not a success?": a qualitative study of health professionals' perspectives on support for people with long-term conditions.

BACKGROUND: Support for self-management (SSM) is a prominent strand of health policy internationally, particularly for primary care. It is often discussed and evaluated in terms of patients' knowledge, skills and confidence, health-related behaviours, disease control or risk reduction, and service use and costs. However, these goals are limited, both as guides to professional practice and as indicators of its quality. In order to better understand what it means to support self-management well, we examined health professionals' views of success in their work with people with long-term conditions. This study formed part of a broader project to develop a conceptual account of SSM that can reflect and promote good practice. METHODS: Semi-structured individual interviews (n = 26) and subsequent group discussions (n = 5 groups, 30 participants) with diverse health professionals working with people with diabetes and/or Parkinson's disease in NHS services in London, northern England or Scotland. The interviews explored examples of more and less successful work, ways of defining success, and ideas about what facilitates success in practice. Subsequent group discussions considered the practical implications of different accounts of SSM. Interviews and group discussions were audio-recorded, transcribed and analysed thematically. RESULTS: Participants identified a wide range of interlinked aspects or elements of success relating to: health, wellbeing and quality of life; how well people (can) manage; and professional-patient relationships. They also mentioned a number of considerations that have important implications for assessing the quality of their own performance. These considerations in part reflect variations in what matters and what is realistically achievable for particular people, in particular situations and at particular times, as well as the complexity of questions of attribution. CONCLUSIONS: A nuanced assessment of the quality of support for self-management requires attention to the responsiveness of professional practice to a wide, complex range of personal and situational states, as well as actions and interactions over time. A narrow focus on particular indicators can lead to insensitive or even perverse judgements and perhaps counterproductive effects. More open, critical discussions about both success and the assessment of quality are needed to facilitate good professional practice and service improvement initiatives.

Decision aids for people considering taking part in clinical trials.

BACKGROUND: Several interventions have been developed to promote informed consent for participants in clinical trials. However, many of these interventions focus on the content and structure of information (e.g. enhanced information or changes to the presentation format) rather than the process of decision making. Patient decision aids support a decision making process about medical options. Decision aids support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes, and provide structured guidance on steps of decision making. They have been shown to be effective for treatment and screening decisions but evidence on their effectiveness in the context of informed consent for clinical trials has not been synthesised. OBJECTIVES: To assess the effectiveness of decision aids for clinical trial informed consent compared to no intervention, standard information (i.e. usual practice) or an alternative intervention on the decision making process. SEARCH METHODS: We searched the following databases and to March 2015: Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library; MEDLINE (OvidSP) (from 1950); EMBASE (OvidSP) (from 1980); PsycINFO (OvidSP) (from 1806); ASSIA (ProQuest) (from 1987); WHO International Clinical Trials Registry Platform (ICTRP) (http://apps.who.int/trialsearch/); ClinicalTrials.gov; ISRCTN Register (http://www.controlled-trials.com/isrctn/). We also searched reference lists of included studies and relevant reviews. We contacted study authors and other experts. There were no language restrictions. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials comparing decision aids in the informed consent process for clinical trials alone, or in conjunction with standard information (such as written or verbal) or alongside alternative interventions (e.g. paper-based versus web-based decision aids). Included trials involved potential trial participants, or their guardians, being asked to consider participating in a real or hypothetical clinical trial. DATA COLLECTION AND ANALYSIS: At least two authors independently assessed studies for inclusion, extracted reported data and assessed risk of bias. Findings were pooled where appropriate. We used GRADE to assess the quality of the evidence for each outcome. MAIN RESULTS: We identified one study (290 randomised participants) that investigated the effectiveness of decision aids compared to standard information in the informed consent process for clinical trials. This study reported two separate decision aid randomised controlled trials (RCTs). The decision aid trials were nested within two different parent trials focusing on breast cancer in postmenopausal women. One trial focused on informed consent for treatment in women who had previously had surgery for ductal carcinoma in situ (DCIS), the other on informed consent for prevention in women at high risk for breast cancer. Two different decision aids were used in these RCTs, and were compared with standard information.The pooled findings highlight the uncertainty surrounding most reported outcomes, including knowledge, decisional conflict, anxiety, trial participation and attrition. There was very low quality evidence that decision aids lower levels of decisional regret to a small degree (MD -5.53, 95% CI -10.29 to -0.76). No data were identified on several prespecified primary outcomes, including accurate risk perception, values-based decision, or whether potential participants recognised that a decision needed to be made, were able to identify features of options that matter most to individuals, or were involved in the decision. AUTHORS' CONCLUSIONS: There was insufficient evidence to determine whether decision aids to support the informed consent process for clinical trials are more effective than standard information. Additional well designed, adequately powered clinical trials in more diverse clinical and social populations are needed to strengthen the results of this review. More generally, future research on which outcomes are most relevant for assessment in this context would be helpful.

'I've used the word cancer but it's actually good news': discursive performativity of cancer and the identity of urological cancer services.

Drawing on the ethnographic study of urological cancer services, this article explores how a set of particular discourses embedded in the everyday clinical work in a large teaching hospital in the UK helps materialise particular configurations of cancer and related professional identities. Emerging on the intersection of specific socio-material arrangements (cancer survival rates, treatment regimens, cancer staging classifications, metaphors, clinical specialities) and operating across a number of differential relations (curable/incurable, treatable/untreatable, aggressive/nonaggressive), these configurations help constitute the categories of 'good' and 'bad' cancers as separate and contrasting entities. These categories help materialise particular distributions of power and are thus implicated in the making of specific claims about the identity of urological cancer services as unique and privileged. Exploring these issues in view of feminist and material-semiotic approaches to studying science, technology and medicine, this article seeks to move away from the understanding of cancer discourses as primarily linguistic performances, proposing to see them instead as arrangements of practices and relations simultaneously material and semiotic through which particular categories, entities and phenomena acquire their determinate nature. In doing so, it seeks to contribute to sociology's broader concern with discursive performativity of cancer.

Strengthening the ethical assessment of placebo-controlled surgical trials: three proposals.

BACKGROUND: Placebo-controlled surgical trials can provide important information about the efficacy of surgical interventions. However, they are ethically contentious as placebo surgery entails the risk of harms to recipients, such as pain, scarring or anaesthetic misadventure. This has led to claims that placebo-controlled surgical trials are inherently unethical. On the other hand, without placebo-controlled surgical trials, it may be impossible to know whether an apparent benefit from surgery is due to the intervention itself or to the placebo effect. DISCUSSION: In this paper we investigate justifications for placebo-controlled surgical trials and suggest three measures for strengthening their ethical acceptability. We argue that, given the extent, irreversibility and cost of surgical interventions, there is a need for the best possible evidence about their efficacy. In some cases, the strongest evidence will be from placebo-controlled surgical trials, especially where interventions are for outcomes (such as pain) that are likely to elicit a placebo response. In the second part of the paper, we propose three specific measures to increase the ethical acceptability of placebo-controlled surgical trials. The first is structured consultation with the relevant patient community about the risks and benefits of particular placebo-controlled surgical trials. The second seeks to address the therapeutic misconception through the use of educational materials, informed by patient consultation. Finally, we argue for ethical consideration of non-surgeon clinicians who are necessarily involved in the delivery of placebo-surgical interventions. SUMMARY: If there is no appropriate surgical comparator and the risks can be reduced to the absolute minimum (given the type of placebo procedure required), and the research has the support of the relevant patient community, there may be grounds for judging that the potential benefits of specific placebo-controlled surgical trials outweigh the risks. If so justified, the ethical acceptability of placebo-controlled surgical trials can be enhanced through using educational measures to address participant vulnerability, and by recognizing clinicians who are necessary participants in the research.

Rurality, healthcare and crises: Investigating experiences, differences, and changes to medical care for people living in rural areas.

Healthcare provision in rural areas is a global challenge, characterised by a dispersed patient population, difficulties in the recruitment and retention of healthcare professionals and a physical distance from hospital care. This research brings together both public and doctor perspectives to explore the experience of healthcare across rural Scotland, against the backdrop of contemporary crises, including a global pandemic and extreme weather events. We draw on two studies on rural healthcare provision to understand how healthcare services have been experienced, changed and might move on after periods of short- and longer-term change caused by such crises. We highlight the importance of communicating service changes to aid in setting healthcare expectations and advocate a mixed approach to the introduction of digital solutions to best balance access to services in rural areas with the challenges of digital connectivity and literacy.

Protective and risk factors of mental health of working age adults with adventitious total bilateral blindness and low vision: A scoping review protocol.

Vision loss has been associated with mental health problems such as depression, anxiety, and post-traumatic stress disorder, which significantly impact lives of working age adults with adventitious total bilateral blindness and low vision. It is imperative, therefore, to prioritize the mental health in this population by exploring and understanding the factors that impact on their mental health. Hence, the objective of this scoping review is to identify and chart existing literature on the protective and risk factors of mental health of working age adults with adventitious total bilateral blindness and low vision. We developed this scoping review protocol in line with the Joanna Briggs Institute guidance. This scoping review will include publications in English language with no date restrictions exploring the protective and risk factors of mental health of our study population. A three-step search strategy will be employed. Searches will be carried out in the following databases: Medline, Embase, PsycInfo, PsycArticles, CINAHL and Web of Science. Search for grey literature will be conducted in Google, Google Scholar and Websites dedicated to information on visual impairment. Collated results will be imported into Endnote Basic (Clarivate) for deduplication. Two reviewers will independently conduct double screening of all the titles and abstracts in Rayyan- a web application, and full texts in Endnote while three other reviewers will conduct screening of a subset of for example 10% of titles and abstracts and full texts. Furthermore, two reviewers will independently conduct double data extraction while three other reviewers will revise, cross check, and correct any extraction errors. Extracted data will be presented in tabular formats and summarized descriptively in line with the research objectives. This scoping review will generate evidence on factors impacting the mental health of the working age adults with adventitious total bilateral blindness and low vision as well as critically highlight gaps in the literature. The findings will inform and critically underpin future empirical research which will explore the lived experiences of working age people with adventitious total bilateral blindness. Additionally, evidence from this review will inform the development of interventions in the promotion of mental health as well as assisting rehabilitation specialists and workers, public health practitioners and other relevant stakeholders in addressing the mental health needs of working age adults with adventitious total bilateral blindness and low vision.

Determining information for inclusion in a decision-support intervention for clinical trial participation: a modified Delphi approach.

BACKGROUND: The use of decision-support interventions in the context of decisions about trial participation is an emergent field. There is a lack of evidence about what information is deemed important to support decisions about informed consent for clinical trials, and whether different groups agree on the information for inclusion. PURPOSE: The overall objective was to determine the items which different stakeholder groups viewed to be important for inclusion in a decision-support tool when making decisions about clinical trial participation, with a view to use these as a framework for developing decision-support tools in this context. This is the first study to have addressed this issue. METHODS: A modified Delphi method was used to determine agreement on importance of items. The 'stakeholder' panel was made up of 49 individuals from 5 groups: 11 trialists, 6 research nurses, 7 ethics committee chairs, 9 decision-support experts, and 16 patients (9 trial experienced and 7 trial non-experienced). Two rounds of rating were completed. Items with a median of 7-10 with ≥65% of any one group (from aggregate ratings) in agreement were considered important for inclusion. RESULTS: The stakeholder panel achieved consensus on the majority of items included (60/66), agreeing that these were important for inclusion in a decision-support tool for trial participation. These included items covering information about trial participation and standard care, information on the likelihood of receiving different treatments, information to help patients determine what matters most to them, ensuring that the information is balanced, guidance on how to make a decision, disclosure of any conflicts of interest, using plain language in the tool, and guidance on the decision-support development process. Some areas of divergence among the panel were also identified relating to the use of patient stories. LIMITATIONS: Selection bias may be a limitation in this study due to the manner in which the participants were invited to take part, and therefore, the representativeness, and reproducibility with another group of stakeholders, may differ. CONCLUSIONS: Agreement was obtained on a number of items, which we recommend should be used as a framework to develop useful tools to support decision-making about participation in clinical trials.

Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

BACKGROUND: Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. PURPOSE: We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. METHODS: An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. RESULTS: The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%-77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. LIMITATIONS: Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. CONCLUSIONS: CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.

Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristics.

OBJECTIVE: Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. STUDY DESIGN: Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication. RESULTS: 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. CONCLUSIONS: Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs.

Impact of Long Covid on the school experiences of children and young people: a qualitative study.

OBJECTIVES: To explore the impact of Long Covid (LC) on the school experiences of children and young people (CYP). DESIGN: Qualitative study using narrative interviews. PARTICIPANTS: 22 CYP (aged 10-18 years, 15 female) with LC and 15 parents/caregivers (13 female) of CYP (aged 5-18 years) with LC. SETTING: Interviews were conducted between October 2021 and July 2022 via online video call or telephone. Recruitment routes included social media, LC support groups, clinicians, community groups and snowballing. RESULTS: Three key findings were identified. Finding 1: Going to school is a valued part of CYP's lives and participants viewed educational attainment as important for their future trajectories. Returning to school full time was highlighted as a key part of regaining 'normal life'. Finding 2: Attending school (in-person or online) with LC is extremely difficult; even a gradual return required CYP to balance the impact of being at and engaging with school, with the need to manage symptoms to prevent relapse. Often this meant prioritising school and rest over other aspects of their lives. Finding 3: School responses to CYP with LC were reported to be mixed and hampered by difficulties communicating with healthcare professionals during the pandemic and a lack of awareness of LC among healthcare and education professionals. Participants viewed supportive school responses as staff believing, understanding and taking them seriously, alongside schools offering tailored and flexible adaptations which allowed engagement with school while limiting any deterioration of symptoms. CONCLUSIONS: This study describes how LC affects the school experiences of CYP and generates recommendations for supportive school responses alongside supportive healthcare professionals. Further research could explore the approaches that facilitate a successful return to school for CYP with LC and investigate education professionals' perspectives on support they require to positively engage with returning pupils.

Valuing place in doctors' decisions to work in remote and rural locations.

Recruitment and retention of medical practitioners is a challenging contemporary issue for rural and remote areas. In this paper, we explore the importance of what it is that doctors value in rural and remote places from their own personal, organisational, social and spatial lives. We do this by drawing on original research from Scotland that explored doctors' decisions on choosing, or not, to work in remote and rural locations. Three themes are explored: moving and staying, using place to think holistically about places beyond the language of work that recruitment and retention implies; how doctors' professional values and their capacity to enact those values change with time; and how policy landscapes interact and shape rural and remote locations as valued places for doctors to live and work. We end the paper by reiterating the World Health Organization findings that a whole-of-society approach is required to support rural and remote communities to flourish, thus, encouraging doctors and their families to value such places and, ultimately, move and stay.

'Using humanity to change systems' - understanding the work of online feedback moderation: A case study of Care Opinion Scotland.

OBJECTIVE: To gain a deeper understanding of online patient feedback moderation through the organisation of Care Opinion in Scotland. METHODS: An ethnographic study, initially using in-person participant observations, switching to remote methods due to the pandemic. This involved the use of remote observations and interviews. Interviews were carried out with the whole Scottish team (n = 8). RESULTS: Our results identify three major themes of work found in online patient feedback moderation. The first is process work, where moderators make decisions on how to edit and publish stories. The second is emotional labour from working with healthcare experiences and with NHS staff. The third is the brokering/mediation role of Care Opinion, where they must manage the relationships between authors, subscribing healthcare providers and Scottish Government. Our results also capture that these different themes are not independent and can at times influence the others. CONCLUSION: Our results build on previous literature on Care Opinion and provide novel insights into the emotional and brokering/mediation work they undertake. Care Opinion holds a unique position, where they must balance the interests of the key stakeholders. Care Opinion holds the power to amplify authors' voices but the power to make changes to services lies with NHS staff and services. Online moderation work is complex, and moderators require support to carry out their work especially given the emotional impact. Further research is planned to understand how patient stories are used by NHS Scotland, and the emotional labour involved with stories, from both the author and NHS staff perspective.

Behavioural optimisation to address trial conduct challenges: case study in the UK-REBOA trial.

BACKGROUND: Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to deliver complex trial interventions successfully. Few studies have utilised a behavioural framework to assess challenges and develop strategies for effective trial recruitment and delivery of trial interventions. This study reports the application of an innovative methodological approach to understand core trial processes, namely recruitment and intervention delivery, using a behavioural science approach to develop strategies designed to mitigate trial process problems. METHODS: The UK-REBOA trial aims to evaluate the clinical and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (a novel intervention) in injured patients with exsanguinating haemorrhage. A behavioural investigation ('diagnosis') was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to examine trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify influences on behaviour, which were then mapped to techniques for behaviour change and developed into potential solutions. RESULTS: The behavioural diagnosis of the challenges experienced during trial processes highlighted factors relevant to a range of TDF domains: Skills, Environmental context and resources, Beliefs about capabilities, Beliefs about consequences, Social influences, and Memory, attention, and decision-making processes. Within the solution development phase, we identified 24 suitable behaviour change techniques that were developed into proposed solutions to target reported process problems with the aim of changing behaviour to improve recruitment and/or intervention delivery. Proposed solutions included targeted changes to trial training content, suggestions to restructure the environment (e.g. reinforced the purpose of the trial with information about the social and environmental consequences) and other strategies to reduce barriers to recruitment and intervention delivery. CONCLUSIONS: This study demonstrates the feasibility of applying a behavioural approach to investigate ('diagnose') behavioural trial process problems and subsequently develop and implement targeted solutions ('treatment') in an active trauma trial. Understanding the factors that affected behaviour, attitudes and beliefs in this trauma trial allowed us to implement theoretically informed, evidence-based solutions designed to enhance trial practices. TRIAL REGISTRATION: ISRCTN 16,184,981.

Mental-physical multimorbidity treatment adherence challenges in Brazilian primary care: A qualitative study with patients and their healthcare providers.

Improved understanding of multimorbidity (MM) treatment adherence in primary health care (PHC) in Brazil is needed to achieve better healthcare and service outcomes. This study explored experiences of healthcare providers (HCP) and primary care patients (PCP) with mental-physical MM treatment adherence. Adults PCP with mental-physical MM and their primary care and community mental health care providers were recruited through maximum variation sampling from nine cities in São Paulo State, Southeast of Brazil. Experiences across quality domains of the Primary Care Assessment Tool-Brazil were explored through semi-structured in-depth interviews with 19 PCP and 62 HCP, conducted between April 2016 and April 2017. Through thematic conent analysis ten meta-themes concerning treatment adherence were developed: 1) variability and accessibility of treatment options available through PHC; 2) importance of coming to terms with a disease for treatment initation; 3) importance of person-centred communication for treatment initiation and maintenance; 4) information sources about received medication; 5) monitoring medication adherence; 6) taking medication unsafely; 7) perceived reasons for medication non-adherence; 8) most challenging health behavior change goals; 9) main motives for initiation or maintenance of treatment; 10) methods deployed to improve treatment adherence. Our analysis has advanced the understanding of complexity inherent to treatment adherence in mental-physical MM and revealed opportunities for improvement and specific solutions to effect adherence in Brazil. Our findings can inform research efforts to transform MM care through optimization.

'They're doing surgery on two people': a meta-ethnography of the influences on couples' treatment decision making for prostate cancer.

BACKGROUND: Current orthodoxy suggests that patients need to be provided with full information about their care and that treatment options should be discussed with patients and family members. This imperative is especially challenging when there is a lack of consensus about treatment effectiveness and equivocacy over different types of interventions. In the case of prostate cancer, evidence is contested as to the efficacy of different treatments. Thus, involving patients and their family members in treatment choices is complex and little is known about how patients and their partners process these decisions when there is uncertainty about different outcomes. This paper has reviewed the literature on the way couples approach such decision making in relation to treatment for prostate cancer. OBJECTIVE: A meta-ethnographic synthesis of published qualitative papers that focused on the influences on patients', and their partners' treatment decision making for prostate cancer, was conducted in order to identify and understand barriers and facilitators which impact on this process. RESULTS: Our synthesis indicates that the couples' relationship 'dynamic' provides a contextual background against which treatment decisions are negotiated and made. DISCUSSION AND CONCLUSIONS: We propose that the findings from this synthesis can enhance the potential for shared decision making for patients, and their partners, when facing a treatment decision for prostate cancer. By understanding the couples' relationship dynamic pre-diagnosis, clinicians may be able to tailor the communication and information provision to both patients and their partners, providing a personalized approach to treatment decision making.

Anonymity, veracity and power in online patient feedback: A quantitative and qualitative analysis of staff responses to patient comments on the 'Care Opinion' platform in Scotland.

OBJECTIVE: To analyse how staff in one Scottish hospital respond to anonymised patient feedback posted on the nationally endorsed feedback platform Care Opinion; and to understand staff experiences of, and attitudes towards, engaging with Care Opinion data. METHODS: This was a multi-method study comprising: (a) numerical and thematic analysis of stories posted during a six-month period, using a published framework; (b) thematic analysis of interviews with a range of 10 hospital staff responsible for organisational responses to feedback. RESULTS: Seventy-seven stories were published during the six-month period. All received a response, with a mean response time of 3.9 days. Ninety-six responses were made in total, from 20 staff members. Personalisation and tailoring was mostly assessed as performing well against the published framework. Only two 'changes made' were reported. While staff interviewed were mostly understanding of why patients might prefer giving anonymised feedback, some found it uncomfortable and challenging. Participants described instances where they might seek to de-anonymise the individual, in order to pass on personal thanks to the relevant staff member, or to investigate the issue raised and seek resolution offline. Patients did not always want to identify themselves; this could sometimes lead staff to query the veracity or importance of issues raised. Sometimes staff could identify individuals anyway, including one described as 'our regular person'. CONCLUSIONS: Staff used to engaging directly with patients and families, both clinically and in dealing with feedback, need support in dealing with anonymous feedback, and the uncomfortable situation of unequal power it may create.

Exploring non-retention in clinical trials: a meta-ethnographic synthesis of studies reporting participant reasons for drop out.

OBJECTIVES: To undertake a meta-ethnographic synthesis of findings from primary studies reporting qualitative data that have explored participant-reported factors influencing non-retention within a clinical trial context. DESIGN: A systematic search and meta-ethnography was conducted for published papers (from 1946 to July 2018) that contained qualitative data from trial non-retainers. PARTICIPANTS: We identified 11 studies reporting qualitative data from 13 trials. The studies were undertaken between 2008 and 2018. Each study included between 3 and 40 people who had dropped out from a trial, with findings from 168 people in total reported across the papers. RESULTS: Emergent from our synthesis was the significance of trial non-retainers' perceptions around the personal 'fit' of key aspects of the trial with their personal beliefs, preferences, capabilities or life circumstances. These related to their own health state; preferences for receiving trial 'care'; individual capabilities; beliefs about or experiences of trial medication and considerations whether trial participation could be accommodated into their broader lives. All these factors raise important issues around the extent to which initial decisions to participate were fully informed. CONCLUSIONS: To improve retention in clinical trials, researchers should work to reduce the burden on trial participants both through the design of the intervention itself as well as through simplified data collection processes. Providing more detail on the nature of the trial interventions and what can be expected by 'participation' at the consenting stage may prove helpful in order to manage expectations.

Acceptability and feasibility of weight management programmes for adults with severe obesity: a qualitative systematic review.

OBJECTIVES: To improve our understanding of the acceptability of behavioural weight management programmes (WMPs) for adults with severe obesity. DESIGN: A systematic review of qualitative evidence. DATA SOURCES: Medline, Embase, PsycINFO, CINAHL, SCI, SSCI and CAB abstracts were searched from 1964 to May 2017. ELIGIBILITY CRITERIA: Papers that contained qualitative data from adults with body mass index (BMI) ≥35 kg/m2 (and/or the views of providers involved in their care) and considered issues about weight management. DATA EXTRACTION AND SYNTHESIS: Two reviewers read and systematically extracted data from the included papers which were compared, and contrasted according to emerging issues and themes. Papers were appraised for methodological rigour and theoretical relevance using Toye's proposed criteria for quality in relation to meta-ethnography. RESULTS: 33 papers met our inclusion criteria from seven countries published 2007-2017. Findings were presented from a total of 644 participants and 153 programme providers. Participants described being attracted to programmes that were perceived to be novel or exciting, as well as being endorsed by their healthcare provider. The sense of belonging to a group who shared similar issues, and who had similar physiques and personalities, was particularly important and seemed to foster a strong group identity and related accountability. Group-based activities were enjoyed by many and participants preferred WMPs with more intensive support. However, some described struggling with physical activities (due to a range of physical comorbidities) and not everyone enjoyed group interaction with others (sometimes due to various mental health comorbidities). Although the mean BMI reported across the papers ranged from 36.8 to 44.7 kg/m2, no quotes from participants in any of the included papers were linked to specific detail regarding BMI status. CONCLUSIONS: Although group-based interventions were favoured, people with severe obesity might be especially vulnerable to physical and mental comorbidities which could inhibit engagement with certain intervention components.