Understanding non-recreational prescription medication-sharing behaviours: a systematic review.

BACKGROUND: Prescription medication sharing refers to the lending or borrowing of prescription medications where the recipient is someone other than the person for whom the prescription is intended. Sharing prescription medication can cause significant harm. Adverse consequences include an increased risk of side effects, delayed health seeking, and severity of disease. Prevalence estimates vary across different populations and people's reasons for, and perceptions of risks from, sharing are poorly understood. AIM: To better understand prescription medication-sharing behaviours and practices - specifically, the prevalence, types of medications, reasons, perceived benefits and risks, and factors associated with medication sharing. DESIGN AND SETTING: This systematic review included primary studies in any setting, focusing on people who engage in medication sharing. METHOD: Electronic databases were searched from inception of databases to February 2023. RESULTS: In total, 19 studies were included. Prevalence of lifetime sharing ranged from 13% to 78%. All 19 studies reported that analgesics were the most shared, followed by antibiotics (n = 12) and allergy medication (n = 9). Common reasons for sharing were running out of medication (n = 7), cost (n = 7), and emergency (n = 6). Perceived benefits included resolution of the problem and convenience. Perceived risks included adverse drug reactions and misdiagnosis. Characteristics associated with sharing included age, female sex, having asthma, and unused medicines stored at home. CONCLUSION: Findings suggest that medication-sharing behaviour is common and involves a range of medicines for a variety of reasons. Data on the prevalence and predictors of prescription medication sharing are inconsistent. A better understanding of non-modifiable and potentially modifiable behavioural factors that contribute to sharing is needed to support development of effective interventions aimed at mitigating unsafe sharing practices.

Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review.

BACKGROUND: Pragmatic trials evaluating complex health interventions often compare them to usual care. This comparator should resemble care as provided in everyday practice. However, usual care can differ for the same condition, between patients and practitioners, across clinical sites and over time. Heterogeneity within a usual care arm can raise methodological and ethical issues. To address these it may be necessary to standardise what usual care entails, although doing so may compromise a trial's external validity. Currently, there is no guidance detailing how researchers should decide the content of their usual care comparators. We conducted a methodology review to summarise current thinking about what should inform this decision. METHODS: MEDLINE, Embase, CINAHL and PsycINFO were searched from inception to January 2022. Articles and book chapters that discussed how to identify or develop usual care comparators were included. Experts in the field were also contacted. Reference lists and forward citation searches of included articles were screened. Data were analysed using a narrative synthesis approach. RESULTS: One thousand nine hundred thirty records were identified, 1611 titles and abstracts screened, 112 full texts screened, and 16 articles included in the review. Results indicated that the content of a usual care comparator should be informed by the aims of the trial, existing care practices, clinical guidelines, and characteristics of the target population. Its content should also be driven by the trial's requirements to protect participants, inform practice, and be methodologically robust, efficient, feasible and acceptable to stakeholders. When deciding the content of usual care, researchers will need to gather information about these drivers, balance tensions that might occur when responding to different trial objectives, and decide how usual care will be described and monitored in the trial. DISCUSSION: When deciding the content of a usual care arm, researchers need to understand the context in which a trial will be implemented and what the trial needs to achieve to address its aim and remain ethical. This is a complex decision-making process and trade-offs might need to be made. It also requires research and engagement with stakeholders, and therefore time and funding during the trial's design phase. TRIAL REGISTRATION: PROSPERO CRD42022307324.

Co-designing a nature-based intervention to promote postnatal mental health for mothers and their infants: a complex intervention development study in England.

OBJECTIVES: There is burgeoning evidence for the potential of nature-based interventions to improve wellbeing. However, the role of nature in enhancing maternal mental health, child development and early relationships remains relatively unexplored. This study aimed to develop a co-designed nature-based intervention to improve postnatal mothers' and infants' wellbeing. DESIGN, SETTING AND PARTICIPANTS: Person-based and co-design approaches informed the planning and design of the postnatal nature-based intervention. In stage 1, a multidisciplinary team was formed to agree research questions and appropriate methodology, and a scoping review was conducted. Six qualitative focus groups were then held with 30 mothers and 15 professional stakeholders. In stage 2, intervention guiding principles and a logic model were developed, and a stakeholder consensus meeting was convened to finalise the prototype intervention. The research was conducted in Bristol, UK, across voluntary, educational and community-based healthcare settings. RESULTS: Stakeholder consultation indicated significant enthusiasm for a postnatal nature-based intervention. A scoping review identified little existing research in this area. Focus group data are reported according to four broad themes: (1) perceived benefits of a group postnatal nature-based intervention, (2) potential drawbacks and barriers to access, (3) supporting attendance and implementation, and (4) ideas for intervention content. The developed intervention was tailored for mothers experiencing, or at risk of, postnatal mental health difficulties. It was identified that the intervention should facilitate engagement with the natural world through the senses, while taking into account a broad range of postnatal-specific practical and psychological needs. CONCLUSIONS: To our knowledge, this is the first reported use of person-based and co-design approaches to develop a postnatal nature-based intervention. The resulting intervention was perceived by target users to address their needs and preferences. Further research is needed to determine the feasibility, clinical and cost-effectiveness of this approach.

Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP): Protocol for a multicentre cluster randomised trial comparing a complex intervention for medication optimization against usual care.

Introduction: Polypharmacy is increasingly common, and associated with undesirable consequences. Polypharmacy management necessitates balancing therapeutic benefits and risks, and varying clinical and patient priorities. Current guidance for managing polypharmacy is not supported by high quality evidence. The aim of the Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) trial is to evaluate the effectiveness of an intervention to optimise medication use for patients with polypharmacy in a general practice setting. Methods: This trial will use a multicentre, open-label, cluster-randomised controlled approach, with two parallel groups. Practices will be randomised to a complex intervention comprising structured medication review (including interprofessional GP/pharmacist treatment planning and patient-facing review) supported by performance feedback, financial incentivisation, clinician training and clinical informatics (intervention), or usual care (control). Patients with polypharmacy and triggering potentially inappropriate prescribing (PIP) indicators will be recruited in each practice using a computerised search of health records. 37 practices will recruit 50 patients, and review them over a 26-week intervention delivery period. The primary outcome is the mean number of PIP indicators triggered per patient at 26 weeks follow-up, determined objectively from coded GP electronic health records. Secondary outcomes will include patient reported outcome measures, and health and care service use. The main intention-to-treat analysis will use linear mixed effects regression to compare number of PIP indicators triggered at 26 weeks post-review between groups, adjusted for baseline (pre-randomisation) values. A nested process evaluation will explore implementation of the intervention in primary care. Ethics and dissemination: The protocol and associated study materials have been approved by the Wales REC 6, NHS Research Ethics Committee (REC reference 19/WA/0090), host institution and Health Research Authority. Research outputs will be published in peer-reviewed journals and relevant conferences, and additionally disseminated to patients and the public, clinicians, commissioners and policy makers. ISRCTN Registration: 90146150 (28/03/2019).

Trauma-informed approaches to primary and community mental health care: protocol for a mixed-methods systematic review.

INTRODUCTION: Exposure to different types of psychological trauma may lead to a range of adverse effects on trauma survivors, including poor mental and physical health, economic, social and cognitive functioning outcomes. Trauma-informed (TI) approaches to care are defined as a service system grounded in and directed by an understanding of how trauma affects the survivors' neurological, biological, physiological and social development. TI service system involves training of all staff, service improvements and sometimes screening for trauma experiences. The UK started incorporating TI approaches into the National Health Service. While policies recommend it, the evidence base for TI approaches to healthcare is not well established. We aim to conduct a systematic review to synthesise evidence on TI approaches in primary and community mental healthcare globally. METHODS AND ANALYSIS: We will undertake a systematic search for primary studies in Medline, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, Cochrane library, websites of organisations involved in the development and implementation of TI approaches in healthcare, and databases of thesis and dissertation. Included studies will be in English published between 1990 and February 2020. Two reviewers will independently perform study selection with data extraction and quality appraisal undertaken by one reviewer and checked for accuracy by a second reviewer. A results-based convergent synthesis will be conducted where quantitative (narratively) and qualitative (thematically) evidence will be analysed separately and then integrated using another method of synthesis. We set up a trauma survivor group and a professional group to consult throughout this review. ETHICS AND DISSEMINATION: There is no requirement for ethical approval for this systematic review as no empirical data will be collected. The findings will be disseminated through a peer-reviewed publication, scientific and practitioner conferences, and policy briefings targeted at local and national policy makers. PROSPERO REGISTRATION NUMBER: CRD42020164752.

General practitioners' views and experiences in caring for patients after sepsis: a qualitative interview study.

BACKGROUND: Patients surviving critical illnesses, such as sepsis, often suffer from long-term complications. After discharge from hospital, most patients are treated in primary care. Little is known how general practitioners (GPs) perform critical illness aftercare and how it can be improved. Within a randomised controlled trial, an outreach training programme has been developed and applied. OBJECTIVES: The aim of this study is to describe GPs' views and experiences of caring for postsepsis patients and of participating a specific outreach training. DESIGN: Semistructured qualitative interviews. SETTING: 14 primary care practices in the metropolitan area of Berlin, Germany. PARTICIPANTS: 14 GPs who had participated in a structured sepsis aftercare programme in primary care. RESULTS: Themes identified in sepsis aftercare were: continuity of care and good relationship with patients, GP's experiences during their patient's critical illness and impact of persisting symptoms. An outreach education as part of the intervention was considered by the GPs to be acceptable, helpful to improve knowledge of the management of postintensive care complications and useful for sepsis aftercare in daily practice. CONCLUSIONS: GPs provide continuity of care to patients surviving sepsis. Better communication at the intensive care unit-GP interface and training in management of long-term complications of sepsis may be helpful to improve sepsis aftercare. TRIAL REGISTRATION NUMBER: ISRCTN61744782.

Feasibility study of eye movement desensitisation and reprocessing (EMDR) in people with an at-risk mental state (ARMS) for psychosis: study protocol.

INTRODUCTION: Trauma can play an important role in the development of psychosis, yet no studies have investigated whether a trauma-focused psychological therapy could prevent the onset of psychosis in people at high risk of developing this condition. This study aims to establish whether it would be feasible to conduct a multicentre randomised controlled trial (RCT) to investigate the clinical and cost-effectiveness of eye movement desensitisation and reprocessing (EMDR) therapy to prevent the onset of psychosis in people with an at-risk mental state (ARMS). METHODS/ANALYSIS: This is a single-arm trial with a nested qualitative study where all participants (target n=20) will be offered EMDR. Eligible participants are those who meet criteria for ARMS; have experienced a traumatic event before the onset of ARMS symptomatology; and have at least one symptom of post-traumatic stress disorder (PTSD). Participants will be followed up at 4, 8 and 12 months after the baseline assessment. The primary outcome measure is transition to psychosis, and secondary outcome measures include severity of psychotic symptoms, PTSD, depression, anxiety, impaired functioning, health status and resource use. The analysis will aim to establish the rates of recruitment and retention for a large-scale RCT. Interviews with therapists and patients will explore their views of the study and their experiences of delivering or receiving EMDR. ETHICS AND DISSEMINATION: This protocol has been approved by the South West-Cornwall and Plymouth Research Ethics Committee (Reference 18/SW/0037). Findings will be disseminated through journal publications, conference presentations and meetings with service users, their families, mental health professionals and commissioners. TRIAL REGISTRATION NUMBER: ISRCTN31976295.

Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study.

OBJECTIVE: To improve the quality and consistency of intervention development reporting in health research. DESIGN: This was a consensus exercise consisting of two simultaneous and identical three-round e-Delphi studies (one with experts in intervention development and one with wider stakeholders including funders, journal editors and public involvement members), followed by a consensus workshop. Delphi items were systematically derived from two preceding systematic reviews and a qualitative interview study. PARTICIPANTS: Intervention developers (n=26) and wider stakeholders (n=18) from the UK, North America and Europe participated in separate e-Delphi studies. Intervention developers (n=13) and wider stakeholders (n=13) participated in a 1-day consensus workshop. RESULTS: e-Delphi participants achieved consensus on 15 reporting items. Following feedback from the consensus meeting, the final inclusion and wording of 14 items with description and explanations for each item were agreed. Items focus on context, purpose, target population, approaches, evidence, theory, guiding principles, stakeholder contribution, changes in content or format during the development process, required changes for subgroups, continuing uncertainties, and open access publication. They form the GUIDED (GUIDance for the rEporting of intervention Development) checklist, which contains a description and explanation of each item, alongside examples of good reporting. CONCLUSIONS: Consensus-based reporting guidance for intervention development in health research is now available for publishers and researchers to use. GUIDED has the potential to lead to greater transparency, and enhance quality and improve learning about intervention development research and practice.

Attending to design when developing complex health interventions: A qualitative interview study with intervention developers and associated stakeholders.

BACKGROUND: Guidance and frameworks exist to assist those developing health interventions but may offer limited discussion of 'design', the part of development concerned with generating ideas for and making decisions about an intervention's content, format and delivery. The aim of this paper is to describe and understand the views and experiences of developers and associated stakeholders in relation to how design occurs in health intervention development. METHODS: Semi-structured interviews were conducted with 21 people who had developed complex interventions to improve health and/or who were relevant stakeholders (e.g. funders and publishers of intervention development work), regarding their views, experiences and approaches to intervention design. Sampling was purposive in terms of maximising diversity. A thematic inductive analysis was conducted. RESULTS: Approaches to design varied substantially between intervention developers. This contrasted with consistency in other activities undertaken during development, such as literature review. Design also posed more challenges than other parts of development. We identified six 'modes' of design: informed; negotiated; structured; delegated; 'my baby'; and creative partnership. In understanding the differences between these different modes, and the challenges posed by intervention design, we identified three key themes: enabling creativity during the design process; working with different types of knowledge; and 'stabilising' (developing clear shared understandings of) the intervention development to enable design. CONCLUSIONS: Design has received less attention than other activities undertaken when developing interventions to improve health. Developers take a variety of approaches to design and often find it challenging. Guidance for intervention development in health has tended to see design as proceeding in a predictable and controlled manner from acquired knowledge. Our study suggests that design rarely reflects this rational ideal. Future guidance on intervention development in healthcare should support developers to work effectively with different types of knowledge, to help design progress more smoothly and to maximise creativity.

Guidance on how to develop complex interventions to improve health and healthcare.

OBJECTIVE: To provide researchers with guidance on actions to take during intervention development. SUMMARY OF KEY POINTS: Based on a consensus exercise informed by reviews and qualitative interviews, we present key principles and actions for consideration when developing interventions to improve health. These include seeing intervention development as a dynamic iterative process, involving stakeholders, reviewing published research evidence, drawing on existing theories, articulating programme theory, undertaking primary data collection, understanding context, paying attention to future implementation in the real world and designing and refining an intervention using iterative cycles of development with stakeholder input throughout. CONCLUSION: Researchers should consider each action by addressing its relevance to a specific intervention in a specific context, both at the start and throughout the development process.

Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions.

BACKGROUND: Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. Although there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions. METHODS: We used a stepped approach to develop a practical framework for researchers. This consisted of (1) a systematic review of the innovative qualitative methods mentioned in the health literature, (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries, and (3) a framework development and group consensus-building process. RESULTS: The findings are presented in accordance with the CONSORT (Consolidated Standards of Reporting Trials) Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories, and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and short message service, community mapping, spiral walks, pair interviews and visual participatory analysis. CONCLUSIONS: The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention or process (or both) of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.

Understanding successful development of complex health and healthcare interventions and its drivers from the perspective of developers and wider stakeholders: an international qualitative interview study.

OBJECTIVE: Identify how individuals involved in developing complex health and healthcare interventions (developers), and wider stakeholders in the endeavour, such as funders, define successful intervention development and what factors influence how interventions are developed. DESIGN: In-depth interviews with developers and wider stakeholders to explore their views and experiences of developing complex health and healthcare interventions. SETTING: Interviews conducted with individuals in the UK, Europe and North America. PARTICIPANTS: Twenty-one individuals were interviewed: 15 developers and 6 wider stakeholders. Seventeen participants were UK based. RESULTS: Most participants defined successful intervention development as a process that resulted in effective interventions that were relevant, acceptable and could be implemented in real-world contexts. Accounts also indicated that participants aimed to develop interventions that end users wanted, and to undertake a development process that was methodologically rigorous and provided research evidence for journal publications and future grant applications. Participants' ambitions to develop interventions that had real-world impact drove them to consider the intervention's feasibility and long-term sustainability early in the development process. However, this process was also driven by other factors: the realities of resource-limited health contexts; prespecified research funder priorities; a reluctance to deviate from grant application protocols to incorporate evidence and knowledge acquired during the development process; limited funding to develop interventions and the need for future randomised controlled trials (RCTs) to prove effectiveness. Participants expressed concern that these drivers discouraged long-term thinking and the development of innovative interventions, and prioritised evaluation over development and future implementation. CONCLUSIONS: Tensions exist between developers' goal of developing interventions that improve health in the real world, current funding structures, the limited resources within healthcare contexts, and the dominance of the RCT for evaluation of these interventions. There is a need to review funding processes and expectations of gold standard evaluation.

GPs' views and experiences of managing patients with personality disorder: a qualitative interview study.

OBJECTIVE: The aim of this study was to explore GPs' views and experiences of managing patients with personality disorder (PD), and their views on the role of the Improving Access to Psychological Therapies (IAPT) programme as a support service. DESIGN: In-depth interviews, analysed thematically. PARTICIPANTS: Fifteen GPs (7 women and 8 men) of varying age and clinical experience, working in practices that differed in terms of the socio-demographic characteristics of their patient populations. SETTING: Twelve general practices based in the West of England, UK. RESULTS: GPs described patients with PD as being challenging to work with and that this work required dedicated time and care. They described experiencing particular difficulty with monitoring their patient's mental health, as well as having little knowledge about the efficacy or availability of treatments for their attenders with PD. They were aware that this patient population often experienced poor mental health and reported a propensity for them to fall into the gap between primary and secondary mental health services, leaving GPs with little choice but to improvise their own management plans, which occasionally involved funding third-sector treatment options. In terms of IAPT services' role in managing these patients, GPs wanted shorter waiting times, better inter-agency communication, more highly trained therapists and more treatment options for patients with PD. They also wanted the service to be able to 'hold' patients with PD in treatment over a longer period than currently offered. CONCLUSIONS: Findings suggest that, overall, GPs did not consider National Health Service mental health services to offer an effective treatment for patients with PD. While they considered the IAPT programme to be a valuable service for patients with less complex mental health needs, such as depression and anxiety; they felt that the current service provision struggled to meet the needs of patients with more complex mental health needs, as exemplified by people with PD.

Synthesizing Qualitative Data Sets to Improve the Design of Trials and Complex Health Interventions: A Worked Example.

Qualitative researchers are increasingly reanalyzing and synthesizing data sets from different studies, and this method has now been used across trials to inform trial methodology and delivery. Despite this work, however, limited guidance exists about how this method should be employed. This article details an example in which interview data collected during three primary care depression trials were brought together to explore trial participants' study and treatment journeys. It details the process involved and the decisions made. It also presents findings from this synthesis to illustrate how this method can be used to inform the development of future trials and complex interventions, through raising questions about how researchers currently define and design treatment arms and indicating what factors may improve or hinder participants' engagement with their allocated treatment.

Interventions to support shared decision making for hypertension: A systematic review of controlled studies.

BACKGROUND: Hypertension (high blood pressure) is a common long-term health condition. Patient involvement in treating and monitoring hypertension is essential. Control of hypertension improves population cardiovascular outcomes. However, for an individual, potential benefits and harms of treatment are finely balanced. Shared decision making has the potential to align decisions with the preferences and values of patients. OBJECTIVE: Determine the effectiveness of interventions to support shared decision making in hypertension. SEARCH STRATEGY: Searches in MEDLINE, EMBASE, CINAHL, Web of Science and PsycINFO up to 30 September 2017. ELIGIBILITY CRITERIA: Controlled studies evaluating the effects of shared decision-making interventions for adults with hypertension compared with any comparator in any setting and reporting any outcome measures. RESULTS: Six studies (five randomized controlled trials) in European primary care were included. Main intervention components were as follows: training for health-care professionals, decision aids, patient coaching and a patient leaflet. Four studies, none at low risk of bias, reported a measure of shared decision making; the intervention increased shared decision making in one study. Four studies reported blood pressure between 6 months and 3 years after the intervention; there was no difference in blood pressure between intervention and control groups in any study. Lack of comparability between studies prevented meta-analysis. CONCLUSIONS: Despite widespread calls for shared decision making to be embedded in health care, there is little evidence to inform shared decision making for hypertension, one of the most common conditions managed in primary care.

Assessing the effectiveness of Enhanced Psychological Care for patients with depressive symptoms attending cardiac rehabilitation compared with treatment as usual (CADENCE): a pilot cluster randomised controlled trial.

BACKGROUND: Around 17% of people attending UK cardiac rehabilitation programmes have depression. Optimising psychological wellbeing is a rehabilitation goal, but provision of psychological care is limited. We developed and piloted an Enhanced Psychological Care (EPC) intervention embedded within cardiac rehabilitation, aiming to test key areas of uncertainty to inform the design of a definitive randomised controlled trial (RCT) and economic evaluation. METHODS: An external pilot randomised controlled trial (RCT) randomised eight cardiac rehabilitation teams (clusters) to either usual care of cardiac rehabilitation provision (UC), or EPC in addition to UC. EPC comprised mental health care coordination and patient-led behavioural activation with nurse support. Adults eligible for cardiac rehabilitation following an acute coronary syndrome and identified with new-onset depressive symptoms during an initial nurse assessment were eligible. Measures were performed at baseline and 5- and 8-month follow-ups and compared between EPC and UC. Team and participant recruitment and retention rates, and participant outcomes (clinical events, depression, anxiety, health-related quality of life, patient experiences, and resource use) were assessed. RESULTS: Eight out of twenty teams were recruited and randomised. Of 614 patients screened, 55 were eligible and 29 took part (5%, 95% CI 3 to 7% of those screened), with 15 patient participants cluster randomised to EPC and 14 to UC. Nurse records revealed that 8/15 participants received the maximum number of EPC sessions offered; and 4/15 received no sessions. Seven out of fifteen EPC participants were referred to another NHS psychological service compared to none in UC. We followed up 27/29 participants at 5 months and 17/21 at 8 months. The mean difference (EPC minus UC) in depressive symptoms (Beck Depression Inventory) at follow-up (adjusting for baseline score) was 1.7 (95% CI - 3.8 to 7.3; N = 26) at 5 months and 4.4 (95% CI - 1.4 to 10.2; N = 17) at 8 months. DISCUSSION: While valued by patients and nurses, organisational and workload constraints are significant barriers to EPC implementation. There remains a need to develop and test new models of psychological care within cardiac rehabilitation. Our study offers important data to inform the design of future trials of similar interventions. TRIAL REGISTRATION: ISRCTN34701576 . Registered on 29 May 2014. Funding details: UK NIHR HTA Programme (project 12/189/09).

"I've made this my lifestyle now": a prospective qualitative study of motivation for lifestyle change among people with newly diagnosed type two diabetes mellitus.

BACKGROUND: Diagnosis with Type 2 Diabetes is an opportunity for individuals to change their physical activity and dietary behaviours. Diabetes treatment guidelines recommend theory-based, patient-centred care and advocate the provision of support for patient motivation but the motivational experiences of people newly diagnosed with diabetes have not been well studied. Framed in self-determination theory, this study aimed to qualitatively explore how this patient group articulate and experience different types of motivation when attempting lifestyle change. METHODS: A secondary analysis of semi-structured interview data collected with 30 (n female = 18, n male = 12) adults who had been newly diagnosed with type two diabetes and were participants in the Early ACTID trial was undertaken. Deductive directed content analysis was performed using NVivo V10 and researcher triangulation to identify and describe patient experiences and narratives that reflected the motivation types outlined in self-determination theory and if/how these changed over time. RESULTS: The findings revealed the diversity in motivation quality both between and within individuals over time and that patients with newly-diagnosed diabetes have multifaceted often competing motivations for lifestyle behaviour change. Applying self-determination theory, we identified that many participants reported relatively dominant controlled motivation to comply with lifestyle recommendations, avoid their non-compliance being "found out" or supress guilt following lapses in behaviour change attempts. Such narratives were accompanied by experiences of frustrating slow behaviour change progress. More autonomous motivation was expressed as something often achieved over time and reflected goals to improve health, quality of life or family time. Motivational internalisation was evident and some participants had integrated their behaviour change to a new way of life which they found resilient to common barriers. CONCLUSIONS: Motivation for lifestyle change following diagnosis with type two diabetes is complex and can be relatively low in self-determination. To achieve the patient empowerment aspirations of current national health care plans, intervention developers, and clinicians would do well to consider the quality not just quantity of their patients' motivation. TRIAL REGISTRATION: ISRCTN ISRCTN92162869 . Retrospectively registered.

Patients' and nurses' views on providing psychological support within cardiac rehabilitation programmes: a qualitative study.

OBJECTIVE: To explore patients' and nurses' views on the feasibility and acceptability of providing psychological care within cardiac rehabilitation services. DESIGN: In-depth interviews analysed thematically. PARTICIPANTS: 18 patients and 7 cardiac nurses taking part in a pilot trial (CADENCE) of an enhanced psychological care intervention delivered within cardiac rehabilitation programmes by nurses to patients with symptoms of depression. SETTING: Cardiac services based in the South West of England and the East Midlands, UK. RESULTS: Patients and nurses viewed psychological support as central to good cardiac rehabilitation. Patients' accounts highlighted the significant and immediate adverse effect a cardiac event can have on an individual's mental well-being. They also showed that patients valued nurses attending to both their mental and physical health, and felt this was essential to their overall recovery. Nurses were committed to providing psychological support, believed it benefited patients, and advocated for this support to be delivered within cardiac rehabilitation programmes rather than within a parallel healthcare service. However, nurses were time-constrained and found it challenging to provide psychological care within their existing workloads. CONCLUSIONS: Both patients and nurses highly value psychological support being delivered within cardiac rehabilitation programmes but resource constraints raise barriers to implementation. Consideration, therefore, should be given to alternative forms of delivery which do not rely solely on nurses to enable patients to receive psychological support during cardiac rehabilitation. TRIAL REGISTRATION NUMBER: ISCTRN34701576.

Children's, parents' and health professionals' views on the management of childhood asthma: a qualitative study.

The management of childhood asthma is often sub-optimal. Parents and other caregivers are primarily responsible for disease management and this responsibility includes communication with health professionals. The aim of this multi-perspective qualitative study was to explore the views of children, parents and health professionals to gain insight into the approach to clinical care in the management of childhood asthma. Interviews were held with nine parent-child (6-8 years) dyads, and 13 health professionals working in primary and secondary care. Interviews were transcribed verbatim and analysed thematically. Three key themes emerged that were common to all data sets; (1) Child and parent awareness of symptoms; (2) Management and child wellbeing; and (3) Professional communication education and consultation with families. Although some children demonstrate good awareness of symptoms and appropriate use of medication, some parents expressed difficulty in identifying triggers and symptoms of asthma. Furthermore, parents lacked awareness regarding appropriate use of medication for preventing and managing symptoms of asthma. Health professionals believed that communication and education was lacking. Data from all participants suggested that consultations could be enhanced with greater emphasis on children's and parents' perceptions of asthma in the development of asthma management plans. CHILDHOOD ASTHMA: GUIDING FAMILIES THROUGH DISEASE MANAGEMENT: Both parents' and children's perceptions and understanding of childhood asthma should be considered when developing asthma management plans. The management of asthma is challenging and can result in poor disease outcomes if care is not taken. An individual's perception of their (or their child's) asthma can also affect the efficacy of treatment. Aidan Searle at the Bristol Biomedical Research Centre, UK, and co-workers, interviewed nine parent-child groups and thirteen health professionals to determine their perceptions of childhood asthma management in primary care. While some children had a strong awareness of symptoms and appropriate medication use, some parents found it difficult to identify asthma triggers and symptoms. Parents also displayed a lack of understanding of management through medication. Health professionals focused on the need for clearer information for families when guiding management of childhood asthma.

Exploring patients' treatment journeys following randomisation in mental health trials to improve future trial conduct: a synthesis of multiple qualitative data sets.

BACKGROUND: The way in which pragmatic trials are designed suggests that there are differences between the experiences of participants randomised to usual care and intervention arms. These potential differences relate not only to which treatment participants receive but also how they access and engage with their allocated treatment. Such differences could affect trial results. The aim of this study was to assess whether such differences exist and, if they do, to consider their implications for the design of future trials. METHODS: Interview transcripts were sampled from data sets gathered during three qualitative studies, all of which had been nested within large, primary care depression trials. Each study had explored trial participants' views and experiences of treatments received following randomisation. Transcripts from 37 participants were purposefully sampled, 20 of which were from interviews held with individuals allocated to receive usual GP care. Data were analysed thematically. RESULTS: There was evidence of differences between trial arms across all three data sets. Intervention participants were willing and able to engage with the treatment to which they had been allocated. Randomisation had led to them embarking upon a clear treatment pathway and receiving care in a context where they felt comfortable discussing their mental health and had sufficient time to do so. Intervention participants also had continuity with and confidence in the practitioners they saw. A few usual-care participants talked about having continuity with and confidence in their GPs. However, most of the usual-care participants reported a reluctance to consult GPs about mental health, difficulties in securing treatment appointments, and little or no changes in care following randomisation. Additionally, most reported a lack of continuity of care and a lack confidence in the treatment available to them. CONCLUSIONS: There are important differences between usual-care and intervention arms that go beyond treatment received, and they relate to how participants experience accessing and engaging with their allocated care. As these differences could affect trial results, researchers may want to measure or reduce them in order to fully appreciate or control for the range of factors that might affect treatment outcomes.