Supported self-management for all with musculoskeletal pain: an inclusive approach to intervention development: the EASIER study.

BACKGROUND: Supported self-management interventions for patients with musculoskeletal (MSK) conditions may not adequately support those with limited health literacy, leading to inequalities in care and variable outcomes. The aim of this study was to develop a model for inclusive supported self-management intervention(s) for MSK pain that take account of health literacy. METHODS: A mixed methods study with four work-packages was conducted: work package 1: secondary analysis of existing data to identify potential targets for intervention; work package 2: evidence synthesis to assess effective components of self-management interventions taking into account health literacy; work package 3: views of community members and healthcare professionals (HCPs) on essential components; work package 4: triangulation of findings and an online modified Delphi approach to reach consensus on key components of a logic model. FINDINGS: Findings identified targets for intervention as self-efficacy, illness perceptions, and pain catastrophizing. A range of intervention components were identified (e.g. information in diverse formats offered at specific times, action planning and visual demonstrations of exercise). Support should be multi-professional using a combination of delivery modes (e.g. remote, face-to-face). CONCLUSIONS: This research has developed a patient-centred model for a multi-disciplinary, multi-modal approach to supported self-management for patients with MSK pain and varying levels of health literacy. The model is evidence-based and acceptable to both patients and HCPs, with potential for significant impact on the management of MSK pain and for improving patient health outcomes. Further work is needed to establish its efficacy.

Risk-based stratified primary care for common musculoskeletal pain presentations: qualitative findings from the STarT MSK cluster randomised controlled trial.

BACKGROUND: The STarT MSK cluster randomised controlled trial (RCT) investigated the clinical- and cost-effectiveness of risk-based stratified primary care versus usual care for patients with back, neck, shoulder, knee or multi-site pain. Trial quantitative results showed risk-based stratified care was not superior to usual care for patients' clinical outcomes, but the intervention led to some changes in GP clinical decision-making. This paper reports a linked qualitative study exploring how risk-based stratified care was perceived and used in the trial, from the perspectives of clinicians and patients. METHODS: Semi-structured interviews were conducted with 27 patients, and focus groups and interviews with 20 clinicians (GPs and physiotherapists) in the intervention arm of the trial. Data were analysed thematically and findings explored using Normalisation Process Theory (NPT) and the COM-B model. MAIN FINDINGS: Risk-based stratified care (subgrouping and matching treatments) was found to have 'coherence' (i.e. made sense) to several clinicians and patients, in that it was well-integrated in practice, and supported clinical decision-making. However, for some GPs stratified care was less 'meaningful', as the risk-stratification tool did not fit with usual ways of consulting and added to already time-pressured consultations. GPs reported giving more patients written information/advice due to easier access to electronic information leaflets through the trial template and were motivated to refer patients to physiotherapy as they believed the trial resulted in faster physiotherapy access (although this was not the case). Patients and clinicians reported that risk-based stratified care influenced conversations in the consultation, prompting greater attention to psychosocial factors, and facilitating negotiation of treatment options. Physiotherapists saw benefits in receiving information about patients' risk subgroup on referral forms. CONCLUSION: These findings provide context for interpreting some of the trial outcomes, particularly in relation to changes in clinical decision-making when risk-based stratified care was used. Findings also indicate potential reasons for lack of GP engagement with risk-based stratified care. Positive outcomes were identified that were not captured in the quantitative data, specifically that risk-based stratified care positively influenced some GP-patient conversations and facilitated negotiation of treatment options. TRIAL REGISTRATION: ISRCTN15366334 (26/04/2016).

Student assistantship programme: an evaluation of impact on readiness to transit from medical student to junior doctor.

BACKGROUND: Studies report that medical graduates are not prepared for practice as expected, and interventions have been developed to prepare them for practice. One such intervention is the assistantship, which provides hands-on opportunities to hone clinical skills and undertake responsibilities under supervision. The Lee Kong Chian School of Medicine (LKCMed) is Singapore's newest medical school, and students undergo a Student Assistantship Programme (SAP) to prepare for practice as junior doctors (PGY1). This study evaluated the SAP from the students' and clinical supervisors' perspectives. METHODS: Students completed online questionnaires to assess readiness for practice before and after SAP, and a subsample were interviewed about their experiences of SAP and its impact on their preparedness for PGY1. In addition, after our graduates had begun work as PGY1 doctors, their clinical supervisors completed an online questionnaire and were interviewed about the perceived benefits of SAP and the attributes of our graduates as junior doctors. RESULTS: Fifty (96%) students completed the pre-SAP questionnaire and 46 (92%) completed the post-SAP questionnaire. Levels of preparedness increased post-SAP (mean scores range pre-SAP: 2.38 to 4.32 vs post-SAP: 3.08 to 4.48); so did opportunities to undertake PGY1 duties (pre-SAP: 56% vs post-SAP: 96%), and hands-on experience in medical emergencies (pre-SAP: 76% vs post-SAP: 89%).Experience of acute care situations increased except "paracetamol overdose". Readiness to be first respondents in ten acute situations improved (statistically significant for asthma, chronic obstructive pulmonary disease exacerbation, gastrointestinal bleed, sepsis, and adverse drug reactions). Three themes emerged from twenty-five student interviews: learning about the work environment, opportunities to learn in a safe environment, and enhancing SAP for future students. Thirty-three supervisors completed the questionnaire, and 70% rated SAP positively in preparing students for PGY1. Eight supervisors interviewed shared positively about the content, timing, and duration of SAP; and suggested future SAPs help students to develop coping and reflective skills. CONCLUSIONS: The SAP improved students' preparedness and experience across clinical areas, and students felt the SAP helped bridge undergraduate curriculum and work, provided opportunities to hone their skills and learn from junior doctors. Most clinical supervisors rated the SAP effective in preparing students for PGY1. This is the first formal evaluation of an assistantship in Singapore, and the findings are encouraging from the perspective of students and PGY1 supervisors.

Role of social comparison in preparedness for practice as a junior doctor in Singapore: a longitudinal qualitative study.

OBJECTIVES: To date, most research on medical graduates' preparedness for practice has conceptualised preparedness as something possessed by the individual. However, new doctors work within social settings with other people and, given this, we argue that preparedness has a social and comparative dimension. The aim of this paper is to explore medical students'/graduates' self-assessments of their preparedness for practice using the lens of social comparison theory. SETTING: We invited medical students from one of Singapore's three medical schools who were in their final-year Student Assistantship Programme to participate in semi-structured interviews, and follow-up interviews 6 months later when they were working as junior doctors. Data was collected from two cohorts, in 2018 and 2019. Initial analysis of interview transcripts was inductive and thematic. Social comparison theory was used for subsequent theory-driven analysis. PARTICIPANTS: 31 participants took part, of whom 21 also engaged in follow-up interviews. RESULTS: We identified three uses of social comparison: as coping strategy to manage uncertainties in transitions where there was no formal, objective testing of their performance; as a means to confirm their self-perceived preparedness (upwards or downwards, eg, being better or worse prepared than comparator others); and as the basis for decision-making (eg, changing career choices). CONCLUSIONS: Senior medical students and newly-graduated doctors compare themselves with peers and near-peers in terms of prior learning and current performance to evaluate and understand their own performance at work. Future studies need to examine further how the feeling of preparedness or unpreparedness generated from social comparisons may affect subsequent clinical performance and professional development.

Health literacy and health outcomes in patients with low back pain: a scoping review.

BACKGROUND: Low back pain is a leading cause of disability worldwide. Health literacy has been associated with pain intensity and pain control. However, there is a paucity of evidence regarding this association. In the field of low back pain research, inconsistent reporting of outcomes has been highlighted. To address this issue a Core Outcome Set has been developed. OBJECTIVES: The objectives of this scoping review were: (1) The health literacy measures currently employed for low back pain and the aspects of health literacy they include. (2) The low back pain health outcomes included in such work. (3) The extent to which these health outcomes reflect the Core Outcome Set for Clinical Trials in Non-Specific Low Back Pain. METHODS: The search included thirteen bibliographic databases, using medical subject heading terms for low back pain and health literacy, and followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. The eligibility criteria were defined by the Joanna Briggs Institute PCC mnemonic. A thematic framework approach was used for analysis. RESULTS: The search yielded ten relevant studies for inclusion, amongst which a total of nine health literacy measures and 50 health outcome measures were used. Most health literacy measures focused on functional health literacy, with few assessing communicative and critical health literacy. The health outcomes assessed by the included studies could be broadly categorised into: Pain, Disability, Behaviour, Knowledge and Beliefs, and Resource Utilisation. Most of these outcome measures studied (36 out of 50) did not directly reflect the Core Outcome Set for Clinical Trials in Non-Specific Low Back Pain. CONCLUSIONS: To allow for comparison across findings and the development of a rigorous evidence base, future work should include the Core Outcome Set for Clinical Trials in Non-Specific Low Back Pain. There is an urgent need to broaden the evidence-base to include regions where low back pain morbidity is high, but data is lacking. Such work demands the incorporation of comprehensive measures of health literacy that have both generic and culturally sensitive components.

Integrating clinician support with intervention design as part of a programme testing stratified care for musculoskeletal pain in general practice.

BACKGROUND: Stratified care involves subgrouping patients based on key characteristics, e.g. prognostic risk, and matching these subgroups to early treatment options. The STarT-MSK programme developed and tested a new stratified primary care intervention for patients with common musculoskeletal (MSK) conditions in general practice. Stratified care involves changing General Practitioners' (GPs) behaviour, away from the current 'stepped' care approach to identifying early treatment options matched to patients' risk of persistent pain. Changing healthcare practice is challenging, and to aid the successful delivery of stratified care, education and support for GPs was required. This paper details the iterative development of a clinician support package throughout the lifespan of the programme, to support GPs in delivering the stratified care intervention. We argue that clinician support is a crucial aspect of the intervention itself, which is often overlooked. METHODS: Qualitative research with patients and GPs identified barriers and facilitators to the adoption of stratified care, which were mapped onto the Theoretical Domains Framework (TDF). Identified domains were 'translated' into an educational paradigm, and an initial version of the support package developed. This was further refined following a feasibility and pilot RCT, and a finalised support package was developed for the main RCT. RESULTS: The clinician support package comprised face-to-face sessions combining adult-learning principles with behaviour change theory in a multimethod approach, which included group discussion, simulated consultations, patient vignettes and model consultation videos. Structured support for GPs was crucial to facilitate fidelity and, ultimately, a successful trial. Clinician support is a two-way process- the study team can learn from and adapt to specific local factors and issues not previously identified. The support from senior clinicians was required to ensure 'buy in'. Monitoring of GP performance, provision of regular feedback and remedial support are important aspects of effective clinician support. CONCLUSION: Designing effective clinician support from the onset of trial intervention design, in an evidence-based, theory-informed manner, is crucial to encourage active engagement and intervention fidelity within the trial, enabling the delivery of a robust and reliable proof-of-principle trial. We offer practical recommendations for future general practice interventions.

"When nothing happens, nobody is afraid!" beliefs and perceptions around self-care and health-seeking behaviours: Voices of patients living with diabetic lower extremity amputation in primary care.

Self-management and self-care are the cornerstone of diabetes care and an essential part of successfully preventing or delaying diabetes complications. Yet, despite being armed with the required information and guidance for self-management, self-care and adherence to foot self-care recommendations and compliance to medication among patients with diabetic foot ulcer and diabetic lower extremity amputations remain low and suboptimal. This study reveals in-depth account of nine such patients' beliefs and perceptions around their illness, their self-care, and their health-seeking behaviours. Patients living with diabetic lower extremity amputation displayed profound lack of knowledge of self-care of diabetes and foot and passive health-related behaviours. The overarching sense that "when nothing happens, nobody is afraid," points to a lack of motivation in taking charge of one's own health, whether this is with reference to treatment or care adherence, following recommended self-care advice, or seeking timely treatment. The Health Beliefs Model provides the theoretical framework for probing into the factors for the participants' suboptimal self-care and passive health-seeking behaviours. Two themes emerged from data analysis: profound knowledge deficit and passive health-related behaviours. The beliefs and perceptions around self-care and health-seeking behaviours for patients with lower extremity amputation are interpreted as the "ignorant self" with passive health-seeking behaviours. Patients with diabetes and diabetic foot diseases may benefit from personalized education, motivational interviewing, and family support.

Implementing patient direct access to musculoskeletal physiotherapy in primary care: views of patients, general practitioners, physiotherapists and clinical commissioners in England.

PURPOSE: Musculoskeletal problems are the leading cause of chronic disability. Most patients in the UK seek initial care from general practitioners (GPs), who are struggling to meet demand. Patient direct access to National Health Service physiotherapy is one possible solution. The purpose of this study was to understand the experiences of patients, GPs, physiotherapists and clinical commissioners on direct access in a region in England with it commissioned. METHODS: The study was informed by Normalisation Process Theory (NTP). Data collection was via semi-structured individual face-to-face and telephone interviews with 22 patients and 20 health care professionals (HCPs). Data were analysed thematically using NPT. RESULTS: Three themes emerged: understanding physiotherapy and the direct access pathway; negotiating the pathway; making the pathway viable. HCPs saw direct access as acceptable. Whilst patients found the concept of direct access, those with complex conditions continued to see their GP as first point of contact. Some GPs and patients reported a lack of clarity around the pathway, reflected in ambiguous paperwork and inconsistent promotion. Operational challenges emerged in cross-disciplinary communication and between HCPs and patients, and lack of adequate resources. CONCLUSION: Direct access to NHS musculoskeletal physiotherapy is acceptable to patients and HCPs. There is need to ensure: effective communication between HCPs and with patients, clarity on the scope of physiotherapy and the direct access pathway, and sufficient resources to meet demand. Patient direct access can free GPs to focus on those patients with more complex health conditions who are most in need of their care.

Struggling for normality: experiences of patients with diabetic lower extremity amputations and post-amputation wounds in primary care.

AIM: To explore the experiences of patients living with diabetic lower extremity amputation (DLEA) and its post-amputation wound in primary care. BACKGROUND: DLEA, including both minor and major amputation, is a life-altering condition that brings numerous challenges to an individual's life. Post-amputation physical wound healing is complicated and challenging because of wound dehiscence and prolonged healing times. Understanding patients' experiences after DLEA with a post-amputation wound will enable healthcare professionals to develop interventions to assist patients in physical healing and psychosocial recovery. METHODS: This study employs a qualitative design using interpretative phenomenological analysis (IPA). A purposive maximum variation sample of nine patients who had had lower extremity amputations and post-amputation wound attributed to diabetes in the previous 12 months was recruited from a primary care setting in Singapore. Semi-structured audio recorded one-to-one interviews with a duration of 45-60 min each were conducted between September 2018 and January 2019. The interviews were transcribed verbatim and analysed using IPA. FINDINGS: The essential meaning of the phenomenon 'the lived experiences for patients with DLEA and post-amputated wound' can be interpreted as 'struggling for "normality"' which encompasses four domains of sense making: physical loss disrupted normality, emotional impact aggravated the disrupted normality, social challenges further provoked the disrupted normality, and attempt to regain normality. The study highlights the complex physical and psychosocial transition facing patients after DLEA before post-amputation wound closure. In primary care, an amputation, whether minor or major, is a life-altering experience that requires physical healing, emotional recovery, and social adaptation to regain normality. Patients living with DLEA and a post-amputation wound may benefit from an interdisciplinary team care model to assist them with physical and psychosocial adjustment and resume normality.

Stratified versus usual care for the management of primary care patients with sciatica: the SCOPiC RCT.

BACKGROUND: Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics. OBJECTIVES: The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care. DESIGN: This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial. SETTING: Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK. PARTICIPANTS: Eligible patients were aged ≥ 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery. INTERVENTIONS: In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service. MAIN OUTCOME MEASURES: The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist. RESULTS: A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy. CONCLUSIONS: The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration. LIMITATIONS: Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results. FUTURE WORK: Other approaches to stratified care may provide superior outcomes for sciatica. TRIAL REGISTRATION: Current Controlled Trials ISRCTN75449581. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.

Sciatica is pain that spreads into the leg because of a trapped nerve in the lower back. It can be a very painful condition that affects everyday life and ability to work. People with sciatica usually see their general practitioner first; if they do not get better over time, they may be referred to a physiotherapist or, eventually, to a spinal specialist. It is difficult to know which sciatica patient will do well without much treatment and who might need to see a physiotherapist or spinal specialist sooner. Stratified care is an approach aiming to help decide, early on, which patients need to see which health professionals. It has previously been shown to be helpful for patients with lower-back pain. In a trial of 476 patients with sciatica a stratified care model was tested to see if it led to faster improvements in sciatica-related leg pain, when compared with usual care. Adults seeing their general practitioner with sciatica were invited to attend a research clinic. Those willing to take part were randomly assigned to stratified care or usual care. Patients in the stratified care arm were referred either to physiotherapy for a short or a longer course of treatment, or to undergo magnetic resonance imaging and see a spinal specialist with the magnetic resonance imaging results within 4 weeks. Pain, function and quality-of-life data were collected over 12 months using text messages and questionnaires. Although patients in the stratified care arm improved slightly more quickly (2 weeks, on average), we did not find convincing evidence that stratified care led to better results than usual care. On average, most patients in both trial arms improved in a similar way over 12 months. The stratified care model tested in this trial did not lead to faster recovery for patients with sciatica than usual care.

Patients' and clinicians' perspectives on a 'fast-track' pathway for patients with sciatica in primary care: qualitative findings from the SCOPiC stratified care trial.

BACKGROUND: Sciatica is common and associated with significant impacts for the individual and society. The SCOPiC randomised controlled trial (RCT) (trial registration: ISRCTN75449581 ) tested stratified primary care for sciatica by subgrouping patients into one of three groups based on prognostic and clinical indicators. Patients in one group were 'fast-tracked' for a magnetic resonance imaging (MRI) scan and spinal specialist opinion. This paper reports qualitative research exploring patients' and clinicians' perspectives on the acceptability of this 'fast-track' pathway. METHODS: Semi-structured interviews were conducted with 20 patients and 20 clinicians (general practitioners, spinal specialist physiotherapists, spinal surgeons). Data were analysed thematically and findings explored using Normalisation Process Theory (NPT) and 'boundary objects' concept. RESULTS: Whilst the 'fast-track' pathway achieved a degree of 'coherence' (i.e. made sense) to both patients and clinicians, particularly in relation to providing early reassurance based on MRI scan findings, it was less 'meaningful' to some clinicians for managing patients with acute symptoms, reflecting a reluctance to move away from the usual 'stepped care' approach. Both groups felt a key limitation of the pathway was that it did not shorten patient waiting times between their spinal specialist consultation and further treatments. CONCLUSION: Findings contribute new knowledge about patients' and clinicians' perspectives on the role of imaging and spinal specialist opinion in the management of sciatica, and provide important insights for understanding the 'fast-track' pathway, as part of the stratified care model tested in the RCT. Future research into the early referral of patients with sciatica for investigation and specialist opinion should include strategies to support clinician behaviour change; as well as take into account the role of imaging in providing reassurance to patients with severe symptoms in cases where imaging reveals a clear explanation for the patient's pain, and where this is accompanied by a thorough explanation from a trusted clinical expert.

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.

BACKGROUND: Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. METHODS: We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as "completely recovered" or "much better" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. FINDINGS: Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care. INTERPRETATION: The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica. FUNDING: National Institute for Health Research.

Perspectives on public involvement in health research from Singapore: The potential of a supported group model of involvement.

BACKGROUND: Singapore is an international research hub, with an emphasis on translational clinical research. Despite growing evidence of the positive impact of public involvement (PPI) in research, it remains rare in Singapore. AIMS: To investigate Singaporean public perspectives around the rationale, role and scope for being involved in health research To identify the potential, challenges, facilitators and strategies for implementing PPI in Singapore. DESIGN: Semi-structured qualitative interviews with members of the public, analysed using thematic framework analysis. RESULTS: Twenty people participated. Four main themes emerged: potential benefits; challenges; facilitators; and strategies for implementation. Whilst initially unfamiliar with the concept, all interviewees recognized potential benefits for the research itself and those involved, including researchers. PPI was seen to offer opportunities for public empowerment and strengthening of relationships and understanding between the public, academics and health professionals, resulting in more impactful research. Challenges included a Singaporean culture of passive citizenship and an education system that inculcates deferential attitudes. Facilitators comprised demographic and cultural changes, including trends towards greater individual openness and community engagement. Implementation strategies included formal government policies promoting involvement and informal community-based collaborative approaches. CONCLUSION: Given the socio-political framework in Singapore, a community-based approach has potential to address challenges to PPI and maximize impact. Careful consideration needs to be given to issues of resource and support to enable members of the public to engage in culturally sensitive and meaningful ways that will deliver research best placed to effectively address patient needs.

Computer-Based Stratified Primary Care for Musculoskeletal Consultations Compared With Usual Care: Study Protocol for the STarT MSK Cluster Randomized Controlled Trial.

BACKGROUND: Musculoskeletal (MSK) pain is a major cause of pain and disability. We previously developed a prognostic tool (Start Back Tool) with demonstrated effectiveness in guiding primary care low back pain management by supporting decision making using matched treatments. A logical next step is to determine whether prognostic stratified care has benefits for a broader range of common MSK pain presentations. OBJECTIVE: This study seeks to determine, in patients with 1 of the 5 most common MSK presentations (back, neck, knee, shoulder, and multisite pain), whether stratified care involving the use of the Keele Start MSK Tool to allocate individuals into low-, medium-, and high-risk subgroups, and matching these subgroups to recommended matched clinical management options, is clinical and cost-effective compared with usual nonstratified primary care. METHODS: This is a pragmatic, two-arm parallel (stratified vs nonstratified care), cluster randomized controlled trial, with a health economic analysis and mixed methods process evaluation. The setting is UK primary care, involving 24 average-sized general practices randomized (stratified by practice size) in a 1:1 ratio (12 per arm) with blinding of trial statistician and outcome data collectors. Randomization units are general practices, and units of observation are adult MSK consulters without indicators of serious pathologies, urgent medical needs, or vulnerabilities. Potential participant records are tagged and individuals invited using a general practitioner (GP) point-of-consultation electronic medical record (EMR) template. The intervention is supported by an EMR template (computer-based) housing the Keele Start MSK Tool (to stratify into prognostic subgroups) and the recommended matched treatment options. The primary outcome using intention-to-treat analysis is pain intensity, measured monthly over 6 months. Secondary outcomes include physical function and quality of life, and an anonymized EMR audit to capture clinician decision making. The economic evaluation is focused on the estimation of incremental quality-adjusted life years and MSK pain-related health care costs. The process evaluation is exploring a range of potential factors influencing the intervention and understanding how it is perceived by patients and clinicians, with quantitative analyses focusing on a priori hypothesized intervention targets and qualitative approaches using focus groups and interviews. The target sample size is 1200 patients from 24 general practices, with >5000 MSK consultations available for anonymized medical record data comparisons. RESULTS: Trial recruitment commenced on May 18, 2018, and ended on July 15, 2019, after a 14-month recruitment period in 24 GP practices. Follow-up and interview data collection was completed in February 2020. CONCLUSIONS: This trial is the first attempt, as far as we know, at testing a prognostic stratified care approach for primary care patients with MSK pain. The results of this trial should be available by the summer of 2020. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15366334; http://www.isrctn.com/ISRCTN15366334. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17939.

The challenge of pain identification, assessment, and management in people with dementia: a qualitative study.

BACKGROUND: Painful conditions are common in older adults, including people with dementia. The symptoms associated with dementia (for example, diminished language capacity, memory impairment, and behavioural changes), however, may lead to the suboptimal identification, assessment, and management of pain. Research has yet to qualitatively explore pain management for community-dwelling people with dementia. AIM: To explore pain identification, assessment, and management for community-dwelling people with dementia. DESIGN & SETTING: A qualitative study was undertaken, set in England. METHOD: Semi-structured interviews took place with people with dementia, family caregivers, GPs, and old-age psychiatrists. Data were analysed thematically. RESULTS: Interviews were conducted with eight people with dementia, nine family caregivers, nine GPs, and five old-age psychiatrists. Three themes were identified that related to pain identification and assessment: gathering information to identify pain; the importance of knowing the person; and the use of pain assessment tools. A further three themes were identified that related to pain management: non-drug strategies; concerns related to analgesic medications; and responsibility of the caregiver to manage pain. CONCLUSION: Identifying and assessing the pain experienced by people with dementia was challenging. Most people with dementia, family caregivers, and healthcare professionals supported non-drug strategies to manage pain. The minimal concerns associated with non-drug strategies contrasted the multifactorial concerns associated with analgesic treatment for people with dementia. Given the complexity of pain identification, assessment, and management, primary care should work together with family caregivers and community services, with case finding for pain being considered in all assessment and management plans.

Stratified primary care versus non-stratified care for musculoskeletal pain: qualitative findings from the STarT MSK feasibility and pilot cluster randomized controlled trial.

BACKGROUND: Stratified care involves subgrouping patients based on key characteristics, e.g. prognostic risk, and matching these subgroups to appropriate early treatment options. The STarT MSK feasibility and pilot cluster randomised controlled trial (RCT) examined the feasibility of a future main trial and of delivering prognostic stratified primary care for patients with musculoskeletal pain. The pilot RCT was conducted in 8 UK general practices (4 stratified care; 4 usual care) with 524 patients. GPs in stratified care practices were asked to use i) the Keele STarT MSK development tool for risk-stratification and ii) matched treatment options for patients at low-, medium- and high-risk of persistent pain. This paper reports on a nested qualitative study exploring the feasibility of delivering stratified care ahead of the main trial. METHODS: 'Stimulated-recall' interviews were conducted with patients and GPs in the stratified care arm (n = 10 patients; 10 GPs), prompted by consultation recordings. Data were analysed thematically and mapped onto the COM-B behaviour change model; exploring the Capability, Opportunity and Motivation GPs and patients had to engage with stratified care. RESULTS: Patients reported positive views that stratified care enabled a more 'structured' consultation, and felt tool items were useful in making GPs aware of patients' worries and concerns. However, the closed nature of the tool's items was seen as a barrier to opening up discussion. GPs identified difficulties integrating the tool within consultations (Opportunity), but found this easier as it became more familiar. Whilst both groups felt the tool had added value, they identified 'cumbersome' items which made it more difficult to use (Capability). Most GPs reported that the matched treatment options aided their clinical decision-making (Motivation), but identified some options that were not available to them (e.g. pain management clinics), and other options that were not included in the matched treatments but which were felt appropriate for some patients (e.g. consider imaging). CONCLUSION: This nested qualitative study, using the COM-B model, identified amendments required for the main trial including changes to the Keele STarT MSK tool and matched treatment options, targeting the COM-B model constructs, and these have been implemented in the current main trial. TRIAL REGISTRATION: ISRCTN 15366334.

Embracing a 'new normal': the construction of biographical renewal in young adults' narratives of living with a stoma.

Stoma surgery can be a life-changing procedure due to bodily changes and related psychological responses. Despite previous literature identifying unique challenges for young adults living with a long-term condition, no studies have explored the biographical implications of stoma formation. Drawing on interviews with 13 young adults, aged 18-29 years, with a stoma resulting from inflammatory bowel disease, this article aims to generate new theoretical insights in understanding the process of biographical (re)construction and the wider implications of stoma formation among this group. Data analysis combined constructivist grounded theory and narrative analysis. Whilst two narratives display 'biographical suspension' characterised by a distancing of self from their stoma, the majority of narratives highlight positive transformations in the young adults' conceptions of self; which we explain through the concept of 'biographical renewal'. The liberating effects of stoma surgery allowed young adults to reclaim aspects of their pre-illness selves, yet also reconfigure a new, altered sense of self, culminating in a 'new normal'. However, psychological distress also co-existed alongside these positive representations, revealing a tension that young adults attempt to reconcile through narrativising their experiences. Our findings have implications for the identification and management of the psychological needs of young people with a stoma.

Role of primary care in supporting older adults who self-harm: a qualitative study in England.

BACKGROUND: Self-harm and suicide are major public health concerns. Self-harm is the strongest risk factor for suicide, with the highest suicide rates reported in older populations. Little is known about how older adults access care following self-harm, but they are in frequent contact with primary care. AIM: To identify and explore barriers and facilitators to accessing care within primary care for older adults who self-harm. DESIGN AND SETTING: An exploratory qualitative methods study using semi-structured interviews with older adults and third-sector workers in England. Older adults were invited to participate in one follow-up interview. METHOD: Interviews occurred between September 2017 and September 2018. These were audio-recorded, transcribed verbatim, and data analysed thematically. A patient and public involvement and engagement group contributed to the study design, data analysis, and interpretation. RESULTS: A total of 24 interviews with nine older adults and seven support workers, including eight follow-up interviews with older adults, were conducted. Three themes emerged: help-seeking decision factors; sources of support; and barriers and facilitators to accessing primary care. CONCLUSION: Despite older adults' frequent contact with GPs, barriers to primary care existed, which included stigma, previous negative experiences, and practical barriers such as mobility restrictions. Older adults' help-seeking behaviour was facilitated by previous positive experiences. Primary care is a potential avenue for delivering effective self-harm support, management, and suicide prevention in older adults. Given the complex nature of self-harm, there is a need for primary care to work with other sectors to provide comprehensive support to older adults who self-harm.

Healthcare professionals' perspectives on identifying and managing perinatal anxiety: a qualitative study.

BACKGROUND: Perinatal mental health problems are those that occur during pregnancy or up to 12 months postpartum, and affect up to 20% of women. Perinatal anxiety (PNA) is at least as common as depression during the perinatal phase and can adversely impact on both mother and child. Despite this, research into anxiety has received less attention than depression. The National Institute for Health and Care Excellence guidance on perinatal mental health has identified PNA as a research priority. AIM: To explore the perspectives and experiences of healthcare professionals (HCPs) in the identification and management of PNA. DESIGN AND SETTING: This was a qualitative study in primary and secondary care set in the West Midlands from February 2017 to December 2017. METHOD: Semi-structured interviews (n = 23) with a range of HCPs. Iterative approach to data generation and analysis, using principles of constant comparison. Patient and Public Involvement and Engagement (PPIE) group was involved throughout the study. RESULTS: Twenty-three HCPs interviewed: 10 GPs, seven midwives, five health visitors, and one obstetrician. Four themes were uncovered: PNA as an 'unfamiliar concept'; reliance on clinical intuition and not clinical tools; fragmentation of care; and opportunities to improve care. CONCLUSION: Awareness and understanding of PNA among HCPs is variable, with debate over what is 'normal' anxiety in pregnancy. HCPs suggested that PNA can be challenging to identify, with mixed views on the use and value of case-finding tools. Opportunistic identification was noted to be significant to aid diagnosis. Care for women diagnosed with PNA was reported to be fragmented and interprofessional communication poor. Potential solutions to improve care were identified.