Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment in primary care (ATLANTIS): a randomised, double-blind, placebo-controlled, phase 3 trial.

BACKGROUND: Most patients with irritable bowel syndrome (IBS) are managed in primary care. When first-line therapies for IBS are ineffective, the UK National Institute for Health and Care Excellence guideline suggests considering low- dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown, and they are infrequently prescribed in this setting. METHODS: This randomised, double-blind, placebo-controlled trial (Amitriptyline at Low-Dose and Titrated for Irritable Bowel Syndrome as Second-Line Treatment [ATLANTIS]) was conducted at 55 general practices in England. Eligible participants were aged 18 years or older, with Rome IV IBS of any subtype, and ongoing symptoms (IBS Severity Scoring System [IBS-SSS] score ≥75 points) despite dietary changes and first-line therapies, a normal full blood count and C-reactive protein, negative coeliac serology, and no evidence of suicidal ideation. Participants were randomly assigned (1:1) to low-dose oral amitriptyline (10 mg once daily) or placebo for 6 months, with dose titration over 3 weeks (up to 30 mg once daily), according to symptoms and tolerability. Participants, their general practitioners, investigators, and the analysis team were all masked to allocation throughout the trial. The primary outcome was the IBS-SSS score at 6 months. Effectiveness analyses were according to intention-to-treat; safety analyses were on all participants who took at least one dose of the trial medication. This trial is registered with the ISRCTN Registry (ISRCTN48075063) and is closed to new participants. FINDINGS: Between Oct 18, 2019, and April 11, 2022, 463 participants (mean age 48·5 years [SD 16·1], 315 [68%] female to 148 [32%] male) were randomly allocated to receive low-dose amitriptyline (232) or placebo (231). Intention-to-treat analysis of the primary outcome showed a significant difference in favour of low-dose amitriptyline in IBS-SSS score between groups at 6 months (-27·0, 95% CI -46·9 to -7·10; p=0·0079). 46 (20%) participants discontinued low-dose amitriptyline (30 [13%] due to adverse events), and 59 (26%) discontinued placebo (20 [9%] due to adverse events) before 6 months. There were five serious adverse reactions (two in the amitriptyline group and three in the placebo group), and five serious adverse events unrelated to trial medication. INTERPRETATION: To our knowledge, this is the largest trial of a tricyclic antidepressant in IBS ever conducted. Titrated low-dose amitriptyline was superior to placebo as a second-line treatment for IBS in primary care across multiple outcomes, and was safe and well tolerated. General practitioners should offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration, such as the self-titration document developed for this trial. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme (grant reference 16/162/01).

Opportunities to improve feedback to reduce blood component wastage: Results of a national scheme evaluation.

BACKGROUND: Blood components are costly and scarce. The Blood Stocks Management Scheme (BSMS) was established in the United Kingdom (UK) to support hospital transfusion services and national blood services through collection, analysis, and monthly feedback of data on blood component inventory and wastage management. There is a growing evidence base on how best to deliver feedback for quality improvement. We assessed the quality and utility of the monthly BSMS component reports. METHODS: We assessed the content of BSMS reports issued in March 2023 against established criteria for effective feedback. Two researchers independently rated whether criteria spanning the five domains of goal setting, data collection, feedback content, feedback display and feedback delivery were fully, partially or not met. Disagreements were resolved through discussion. We conducted an online questionnaire survey of recipients of BSMS reports during March 2023 to assess their use of reports and seek suggestions for improvement. RESULTS: Five out of 20 criteria for effective feedback were fully met. Areas for improvement included placing more emphasis in the feedback on positive change, linking data and summary messages, and including specific suggestions for action. Respondents highlighted the value of benchmarked comparisons with other hospital transfusion services. CONCLUSION: There is scope for enhancing the effectiveness and utility of BSMS feedback reports and hence reducing wastage of blood components. This methodology for evaluation of feedback could be utilized to improve other areas of transfusion practice.

A pilot randomised controlled trial of acceptance and commitment therapy for medication decision-making and quality of life in women with breast cancer: The ACTION trial.

OBJECTIVE: Non-adherence to adjuvant endocrine therapy (AET) in women with breast cancer is common and associated with medication side-effects and distress. We co-designed an Acceptance and Commitment Therapy intervention (ACTION) to enhance medication decision-making and quality of life (QoL). We undertook a pilot trial of ACTION to inform the feasibility of a phase III trial, and to examine intervention acceptability. METHODS: This was a multi-site, exploratory, two-arm, individually randomised external pilot trial. Women with early breast cancer prescribed AET were randomised (1:1) to receive usual care (UC) or UC + ACTION. The ACTION intervention comprised a remotely delivered one-to-one ACT session followed by three group sessions delivered by clinical psychologists, alongside a website containing ideas for the self-management of side effects. RESULTS: Of the 480 women screened for eligibility, 260 (54.2%) were approached and 79 (30.4%) randomised. 71 (89.9%) women provided data at 3-month and 70 (88.6%) at 6-month 40 women were randomised to receive UC + ACTION and 32 (80.0%) completed the intervention. Most (75.0%) accessed the website at least once. ACTION was acceptable to participants (Borkovec & Nau Scale: mean = 7.8 [SD = 2.7] out of 10). Signals of effectiveness in favour of the UC + ACTION arm were observed for medication adherence (Adherence Starts with Knowledge questionnaire-12), QoL (work and social adjustment scale), health-related QoL (functional assessment of cancer therapy[FACT] general and FACT-ES-19/23), distress (generalised anxiety disorder -7, patient health questionnaire-9) and psychological flexibility (valuing questionnaire). CONCLUSIONS: The ACTION intervention was acceptable to patients. There were promising signals for effectiveness on primary and secondary outcomes. A phase III randomised controlled trial is feasible. TRIAL REGISTRATION: ISRCTN12027752.

Qualitative research in dental traumatology-A narrative review.

This review highlights the recent contributions of qualitative research in advancing understanding of dental trauma injury and the barriers and enablers to guide policy for improved patient-centred care including transitional care. It summarises the common approaches and methods used and outlines the key factors that guide the appraisal of qualitative studies. It highlights the importance of the application of qualitative research methods in dental research to generate rich and detailed data to provide explanations and insights into people's experiences, beliefs and attitudes and the complexity of human decision-making and behaviour. In the past decade while there have been a growing number of publications of qualitative studies in dental journals, qualitative studies remain a small percentage of the published dental traumatology research. This may be because of limited understanding about the background, methods and rigour of qualitative research.

Priorities for implementation research on diagnosing cancer in primary care: a consensus process.

BACKGROUND: The early detection and diagnosis of cancer to reduce avoidable mortality and morbidity is a challenging task in primary health care. There is a growing evidence base on how to enable earlier cancer diagnosis, but well-recognised gaps and delays exist around the translation of new research findings into routine clinical practice. Implementation research aims to accelerate the uptake of evidence by health care systems and professionals. We aimed to identify priorities for implementation research in early cancer diagnosis in primary care. METHODS: We used a RAND/UCLA modified Delphi consensus process to identify and rank research priorities. We asked primary care physicians, patients and researchers to complete an online survey suggesting priorities for implementation research in cancer detection and diagnosis. We summarised and presented these suggestions to an 11-member consensus panel comprising nine primary care physicians and two patients. Panellists independently rated the importance of suggestions on a 1-9 scale (9 = very high priority; 1 = very low priority) before and after a structured group discussion. We ranked suggestions using median ratings. RESULTS: We received a total of 115 suggested priorities for implementation research from 32 survey respondents (including 16 primary care professionals, 11 researchers, and 4 patient and public representatives; 88% of respondents were UK-based). After removing duplicates and ineligible suggestions, we presented 37 suggestions grouped within 17 categories to the consensus panel. Following two rounds of rating, 27 suggestions were highly supported (median rating 7-9). The most highly rated suggestions concerned diagnostic support (e.g., access to imaging) interventions (e.g., professional or patient education), organisation of the delivery of care (e.g., communication within and between teams) and understanding variations in care and outcomes. CONCLUSIONS: We have identified a set of priorities for implementation research on the early diagnosis of cancer, ranked in importance by primary care physicians and patients. We suggest that researchers and research funders consider these in directing further efforts and resources to improve population outcomes.

Improving data quality from routine clinical appointments-Development of a minimum dataset for traumatic dental injuries in children and adolescents.

BACKGROUND/AIMS: It is currently difficult to evaluate the success or not of treatment for dental injuries due to poor recording of diagnostic and treatment codes in clinical dentistry. A minimum dataset comprises a standardised minimum set of outcomes along with a specified outcome measurement instrument, to allow aggregated use of data from routine clinical care appointments. This study aimed to determine which outcomes should be included in a minimum dataset for traumatic dental injuries (TDI). MATERIALS AND METHODS: This is a three-stage sequential, mixed-methods study, using evidence-based best practice for dataset development. Normalisation process theory informed the development of the study protocols. In Stage 1, semi-structured interviews with patients and their parent or guardian were undertaken to identify outcomes of importance to patients. In Stage 2, an online Delphi survey was undertaken to identify outcomes of importance to clinicians. In Stage 3, a National Consensus Meeting was undertaken involving patient representatives, clinicians and other stakeholders, to agree which outcomes should be included in the minimum dataset. RESULTS: Stage 1: Eleven participants were recruited, five children and six parents. Two key themes emerged from the analysis-communication and aesthetics. In Stage 2, 34 dentists were recruited, and 32 completed both rounds of the survey (97% retention). Most outcomes were deemed by participants to be of 'critical importance', with three outcomes deemed 'important' and none to be 'of limited importance'. In Stage 3, 15 participants took part in the consensus meeting. Participants agreed that the dataset should comprise a list of clinician-important outcomes (pulp healing, periodontal healing, discolouration, tooth loss) and a list of patient-important outcomes (communication, aesthetics, pain, quality of life). CONCLUSION: A Minimum Dataset for TDI has been developed using a robust and transparent methodology.

Implementing personalised care planning for older people with frailty: a process evaluation of the PROSPER feasibility trial.

BACKGROUND: Personalised Care Planning (PCP) is a collaborative approach used in the management of chronic conditions. Core components of PCP are shared decision making to achieve joint goal setting and action planning by the clinician and patient. We undertook a process evaluation within the PROSPER feasibility trial to understand how best to implement PCP for older people with frailty in the community. METHODS: The trial was set in two localities in England. We observed training sessions and intervention delivery at three time points during the 12-week intervention period. We interviewed delivery teams before, during and after the intervention period, as well as primary care staff. We interviewed older people who had received, declined or withdrawn from PCP. We explored training of staff delivering PCP, structures, mechanisms and resources needed for delivery, and influences on uptake. We undertook a framework approach to data analysis. FINDINGS: We observed thirteen training sessions and interviewed seven delivery staff, five primary care staff, and twenty older people, including seven who had declined or withdrawn from the intervention. Delivery teams successfully acquired skills and knowledge, but felt underprepared for working with people with lower levels of frailty. Timing of training was critical and 'top-ups' were needed. Engagement with primary care staff was tenuous. Older people with lower frailty were unclear of the intervention purpose and benefits, goal setting and action planning. CONCLUSIONS: PCP has the potential to address the individualised needs of older people with frailty. However, training requires careful tailoring and is ideally on-going. Considerable efforts are required to integrate statutory and voluntary stakeholders, understanding the expectations and contributions of each agency from the outset. In addition, older people with frailty need time and support to adjust to new ways of thinking about their own health now and in the future so they can participate in shared decision making. These key factors will be essential when developing models of care for delivering PCP to support older people with frailty to sustain their independence and quality of life. TRIAL REGISTRATION: ISRCTN 12,363,970 - 08/11/2018.

Factors influencing follow-up care post-TIA and minor stroke: a qualitative study using the theoretical domains framework.

BACKGROUND: Follow-up care after transient ischaemic attack (TIA) and minor stroke has been found to be sub-optimal, with individuals often feeling abandoned. We aimed to explore factors influencing holistic follow-up care after TIA and minor stroke. METHODS: Qualitative semi-structured interviews with 24 healthcare providers (HCPs): 5 stroke doctors, 4 nurses, 9 allied health professionals and 6 general practitioners. Participants were recruited from three TIA clinics, seven general practices and one community care trust in the West Midlands, England. Interview transcripts were deductively coded using the Theoretical Domains Framework and themes were generated from coded data. RESULTS: There was no clear pathway for supporting people with TIA or minor stroke after rapid specialist review in hospital; consequently, these patients had limited access to HCPs from all settings ('Environmental context and resources'). There was lack of understanding of potential needs post-TIA/minor stroke, in particular residual problems such as anxiety/fatigue ('Knowledge'). Identification and management of needs was largely influenced by HCPs' perceived role, professional training ('Social professional role and identity') and time constraints ('Environmental context and resources'). Follow-up was often passive - with onerous on patients to seek support - and predominantly focused on acute medical management ('Intentions'/'Goal'). CONCLUSIONS: Follow-up care post-TIA/minor stroke is currently sub-optimal. Through identifying factors which influence follow-up, we can inform guidelines and practical strategies to improve holistic healthcare.

Supporting adjuvant endocrine therapy adherence in women with breast cancer: the development of a complex behavioural intervention using Intervention Mapping guided by the Multiphase Optimisation Strategy.

BACKGROUND: Adjuvant endocrine therapy (AET) reduces the risk of breast cancer recurrence and mortality. However, up to three-quarters of women with breast cancer do not take AET as prescribed. Existing interventions to support adherence to AET have largely been unsuccessful, and have not focused on the most salient barriers to adherence. This paper describes the process of developing four theory-based intervention components to support adherence to AET. Our aim is to provide an exemplar of intervention development using Intervention Mapping (IM) with guidance from the Multiphase Optimisation Strategy (MOST). METHODS: Iterative development followed the six-stage IM framework with stakeholder involvement. Stage 1 involved a literature review of barriers to adherence and existing interventions, which informed the intervention objectives outlined in Stage 2. Stage 3 identified relevant theoretical considerations and practical strategies for supporting adherence. Stage 4 used information from Stages 1-3 to develop the intervention components. Stages 1-4 informed a conceptual model for the intervention package. Stages 5 and 6 detailed implementation considerations and evaluation plans for the intervention package, respectively. RESULTS: The final intervention package comprised four individual intervention components: Short Message Service to encourage habitual behaviours surrounding medication taking; an information leaflet to target unhelpful beliefs about AET; remotely delivered Acceptance and Commitment Therapy-based guided self-help to reduce psychological distress; and a website to support self-management of AET side-effects. Considerations for implementation within the NHS, including cost, timing and mode of delivery were outlined, with explanation as to how using MOST can aid this. We detail our plans for the final stage of IM which involve feasibility testing. This involved planning an external exploratory pilot trial using a 24-1 fractional factorial design, and a process evaluation to assess acceptability and fidelity of intervention components. CONCLUSIONS: We have described a systematic and logical approach for developing a theoretically informed intervention package to support medication adherence in women with breast cancer using AET. Further research to optimise the intervention package, guided by MOST, has the potential to lead to more effective, efficient and scalable interventions.

Barriers and facilitators to using aspirin for preventive therapy: a qualitative study exploring the views and experiences of people with Lynch syndrome and healthcare providers.

BACKGROUND: The National Institute for Health and Care Excellence (NG151) recommends considering daily aspirin for people with Lynch syndrome to reduce colorectal cancer risk. However, deciding whether to initiate aspirin could be a complex decision for patients and their healthcare providers, as both the potential benefits and harms need to be considered. METHODS: We conducted semi-structured interviews to explore the barriers and facilitators to using aspirin for preventive therapy. We recruited 15 people with Lynch syndrome, and 23 healthcare providers across multiple professions in primary, and specialist care (e.g. clinical genetics) in the United Kingdom. Interview schedules were informed by the Theoretical Domains Framework. RESULTS: There were three themes: 1) Considering potential harms and benefits; 2) Healthcare pathway; 3) Patients' level of interest in aspirin. All healthcare providers, across primary and specialist care, viewed general practitioners (GPs) as being responsible for prescribing and overseeing the use of aspirin. However, GPs were unfamiliar with aspirin for preventive therapy, and concerned about prescribing at higher doses (300-600 mg). To support decision-making, GPs wanted clarification from specialist clinicians on the evidence and dose to prescribe. Not all participants with Lynch syndrome received information on aspirin from their healthcare provider, and several were unsure who to discuss aspirin with. GPs were more inclined to prescribe aspirin for patients with expressed preferences for the medication, however several patients were uncertain and wanted further guidance. CONCLUSIONS: Coordinated and multilevel strategies are needed, addressing the needs of both GPs and people with Lynch syndrome, to ensure consistent implementation of national guidance on aspirin for preventive therapy.

The effects of an evidence- and theory-informed feedback intervention on opioid prescribing for non-cancer pain in primary care: A controlled interrupted time series analysis.

BACKGROUND: The rise in opioid prescribing in primary care represents a significant international public health challenge, associated with increased psychosocial problems, hospitalisations, and mortality. We evaluated the effects of a comparative feedback intervention with persuasive messaging and action planning on opioid prescribing in primary care. METHODS AND FINDINGS: A quasi-experimental controlled interrupted time series analysis used anonymised, aggregated practice data from electronic health records and prescribing data from publicly available sources. The study included 316 intervention and 130 control primary care practices in the Yorkshire and Humber region, UK, serving 2.2 million and 1 million residents, respectively. We observed the number of adult patients prescribed opioid medication by practice between July 2013 and December 2017. We excluded adults with coded cancer or drug dependency. The intervention, the Campaign to Reduce Opioid Prescribing (CROP), entailed bimonthly, comparative, and practice-individualised feedback reports to practices, with persuasive messaging and suggested actions over 1 year. Outcomes comprised the number of adults per 1,000 adults per month prescribed any opioid (main outcome), prescribed strong opioids, prescribed opioids in high-risk groups, prescribed other analgesics, and referred to musculoskeletal services. The number of adults prescribed any opioid rose pre-intervention in both intervention and control practices, by 0.18 (95% CI 0.11, 0.25) and 0.36 (95% CI 0.27, 0.46) per 1,000 adults per month, respectively. During the intervention period, prescribing per 1,000 adults fell in intervention practices (change -0.11; 95% CI -0.30, -0.08) and continued rising in control practices (change 0.54; 95% CI 0.29, 0.78), with a difference of -0.65 per 1,000 patients (95% CI -0.96, -0.34), corresponding to 15,000 fewer patients prescribed opioids. These trends continued post-intervention, although at slower rates. Prescribing of strong opioids, total opioid prescriptions, and prescribing in high-risk patient groups also generally fell. Prescribing of other analgesics fell whilst musculoskeletal referrals did not rise. Effects were attenuated after feedback ceased. Study limitations include being limited to 1 region in the UK, possible coding errors in routine data, being unable to fully account for concurrent interventions, and uncertainties over how general practices actually used the feedback reports and whether reductions in prescribing were always clinically appropriate. CONCLUSIONS: Repeated comparative feedback offers a promising and relatively efficient population-level approach to reduce opioid prescribing in primary care, including prescribing of strong opioids and prescribing in high-risk patient groups. Such feedback may also prompt clinicians to reconsider prescribing other medicines associated with chronic pain, without causing a rise in referrals to musculoskeletal clinics. Feedback may need to be sustained for maximum effect.

An adaptable implementation package targeting evidence-based indicators in primary care: A pragmatic cluster-randomised evaluation.

BACKGROUND: In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators. METHODS AND FINDINGS: We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used 'opt-out' recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67-0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89-1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96-1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75-1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39-0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve. CONCLUSIONS: In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement. TRIAL REGISTRATION: The study is registered with the ISRCTN registry (ISRCTN91989345).

TIA and minor stroke: a qualitative study of long-term impact and experiences of follow-up care.

BACKGROUND: Transient ischaemic attack (TIA) and minor stroke are often considered transient events; however, many patients experience residual problems and reduced quality of life. Current follow-up healthcare focuses on stroke prevention and care for other long-term problems is not routinely provided. We aimed to explore patient and healthcare provider (HCP) experiences of residual problems post-TIA/minor stroke, the impact of TIA/minor stroke on patients' lives, and current follow-up care and sources of support. METHODS: This qualitative study recruited participants from three TIA clinics, seven general practices and one community care trust in the West Midlands, England. Semi-structured interviews were conducted with 12 TIA/minor stroke patients and 24 HCPs from primary, secondary and community care. Data was analysed using framework analysis. RESULTS: A diverse range of residual problems were reported post-TIA/minor stroke, including psychological, cognitive and physical impairments. Consultants and general practitioners generally lacked awareness of these long-term problems; however, there was better recognition among nurses and allied HCPs. Residual problems significantly affected patients' lives, including return to work, social activities, and relationships with family and friends. Follow-up care was variable and medically focused. While HCPs prioritised medical investigations and stroke prevention medication, patients emphasised the importance of understanding their diagnosis, individualised support regarding stroke risk, and addressing residual problems. CONCLUSION: HCPs could better communicate information about TIA/minor stroke diagnosis and secondary stroke prevention using lay language, and improve their identification of and response to important residual impairments affecting patients.

General practitioners' perceptions of irritable bowel syndrome: a Q-methodological study.

Background: Irritable bowel syndrome (IBS) is a common disorder that imposes a significant burden upon societies, health care and quality of life, worldwide. While a diverse range of patient viewpoints on IBS have been explored, the opinions of the GPs they ideally need to develop therapeutic partnerships with are less well defined. Objective: To explore how GPs perceive IBS, using Q-methodology, which allows quantitative interpretation of qualitative data. Design and Setting: A Q-methodological study of GPs in Leeds, UK. Method: Thirty-three GPs completed an online Q-sort in which they ranked their level of agreement with 66 statements. Factor analysis of the Q-sorts was performed to determine the accounts that predominated in understandings of IBS. Ten of the GPs were interviewed in person and responses to the statements recorded to help explain the accounts. Results: Analysis yielded one predominant account shared by all GPs-that IBS was a largely psychological disorder. This account overshadowed a debate represented by a minority, polarized between those who viewed IBS as almost exclusively psychological, versus those who believed IBS had an organic basis, with a psychological component. The overwhelming similarity in responses indicates that all GPs shared a common perspective on IBS. Interviews suggested degrees of uncertainty and discomfort around the aetiology of IBS. Conclusion: There was overwhelming agreement in the way GPs perceived IBS. This contrasts with the range of patient accounts of IBS and may explain why both GPs and their patients face difficult negotiations in achieving therapeutic relationships.

Primary palliative care team perspectives on coordinating and managing people with advanced cancer in the community: a qualitative study.

BACKGROUND: Primary health care teams are key to the delivery of care for patients with advanced cancer during the last year of life. The Gold Standards Framework is proposed as a mechanism for coordinating and guiding identification, assessment, and support. There are still considerable variations in practice despite its introduction. The aim of this qualitative study is to improve understanding of variations in practice through exploring the perspectives and experiences of members of primary health care teams involved in the care of patients with advanced cancer. METHODS: Qualitative, semi-structured interviews, focus groups, and non-participatory observations involving 67 members of primary health care teams providing palliative care. Data were analysed using a grounded theory approach. RESULTS: We identified distinct differences in the drivers and barriers of community advanced cancer care coordination, which relate to identification and management, and access to effective pain management, and go some way to understanding variations in practice. These include proactive identification processes, time and resource pressures, unclear roles and responsibilities, poor multidisciplinary working, and inflexible models for referral and prescribing. These provide valuable insight into how professionals work together and independently within an infrastructure that can both support and hinder the provision of effective community palliative care. CONCLUSIONS: Whilst the GSF is a guide for good practice, alone it is not a mechanism for change. Rather it provides a framework for describing quality of practice that was already occurring. Consequently, there will continue to be variations in practice.

Optimizing primary care research participation: a comparison of three recruitment methods in data-sharing studies.

BACKGROUND: Recruitment of representative samples in primary care research is essential to ensure high-quality, generalizable results. This is particularly important for research using routinely recorded patient data to examine the delivery of care. Yet little is known about how different recruitment strategies influence the characteristics of the practices included in research. OBJECTIVE: We describe three approaches for recruiting practices to data-sharing studies, examining differences in recruitment levels and practice representativeness. METHODS: We examined three studies that included varying populations of practices from West Yorkshire, UK. All used anonymized patient data to explore aspects of clinical practice. Recruitment strategies were 'opt-in', 'mixed opt-in and opt-out' and 'opt-out'. We compared aggregated practice data between recruited and not-recruited practices for practice list size, deprivation, chronic disease management, patient experience and rates of unplanned hospital admission. RESULTS: The opt-out strategy had the highest recruitment (80%), followed by mixed (70%) and opt-in (58%). Practices opting-in were larger (median 7153 versus 4722 patients, P = 0.03) than practices that declined to opt-in. Practices recruited by mixed approach were larger (median 7091 versus 5857 patients, P = 0.04) and had differences in the clinical quality measure (58.4% versus 53.9% of diabetic patients with HbA1c ≤ 59 mmol/mol, P < 0.01). We found no differences between practices recruited and not recruited using the opt-out strategy for any demographic or quality of care measures. CONCLUSION: Opt-out recruitment appears to be a relatively efficient approach to ensuring participation of typical general practices. Researchers should, with appropriate ethical safeguards, consider opt-out recruitment of practices for studies involving anonymized patient data sharing.

Developing 'high impact' guideline-based quality indicators for UK primary care: a multi-stage consensus process.

BACKGROUND: Quality indicators (QIs) are an important tool for improving clinical practice and are increasingly being developed from evidence-based guideline recommendations. We aimed to identify, select and apply guideline recommendations to develop a set of QIs to measure the implementation of evidence-based practice using routinely recorded clinical data in United Kingdom (UK) primary care. METHODS: We reviewed existing national clinical guidelines and QIs and used a four-stage consensus development process to derive a set of 'high impact' QIs relevant to primary care based upon explicit prioritisation criteria. We then field tested the QIs using remotely extracted, anonymised patient records from 89 randomly sampled primary care practices in the Yorkshire region of England. RESULTS: Out of 2365 recommendations and QIs originally reviewed, we derived a set of 18 QIs (5 single, 13 composites - comprising 2-9 individual recommendations) for field testing. QIs predominantly addressed chronic disease management, in particular diabetes, cardiovascular and renal disease, and included both processes and outcomes of care. Field testing proved to be critical for further refinement and final selection. CONCLUSIONS: We have demonstrated a rigorous and transparent methodology to develop a set of high impact, evidence-based QIs for primary care from clinical guideline recommendations. While the development process was successful in developing a limited set of QIs, it remains challenging to derive robust new QIs from clinical guidelines in the absence of established systems for routine, structured recording of clinical care.

Understanding long-term opioid prescribing for non-cancer pain in primary care: a qualitative study.

BACKGROUND: The place of opioids in the management of chronic, non-cancer pain is limited. Even so their use is escalating, leading to concerns that patients are prescribed strong opioids inappropriately and alternatives to medication are under-used. We aimed to understand the processes which bring about and perpetuate long-term prescribing of opioids for chronic, non-cancer pain. METHODS: We held semi-structured interviews with patients and focus groups with general practitioners (GPs). Participants included 23 patients currently prescribed long-term opioids and 15 GPs from Leeds and Bradford, United Kingdom (UK). We used a grounded approach to the analysis of transcripts. RESULTS: Patients are driven by the needs for pain relief, explanation, and improvement or maintenance of quality of life. GPs' responses are shaped by how UK general practice is organised, available therapeutic choices and their expertise in managing chronic pain, especially when facing diagnostic uncertainty or when their own approach is at odds with the patient's wishes. Four features of the resulting transaction between patients and doctors influence prescribing: lack of clarity of strategy, including the risk of any plans being subverted by urgent demands; lack of certainty about locus of control in decision-making, especially in relation to prescribing; continuity in the doctor-patient relationship; and mutuality and trust. CONCLUSIONS: Problematic prescribing occurs when patients experience repeated consultations that do not meet their needs and GPs feel unable to negotiate alternative approaches to treatment. Therapeutic short-termism is perpetuated by inconsistent clinical encounters and the absence of mutually-agreed formulations of underlying problems and plans of action. Apart from commissioning improved access to appropriate specialist services, general practices should also consider how they manage problematic opioid prescribing and be prepared to set boundaries with patients.

Does a local financial incentive scheme reduce inequalities in the delivery of clinical care in a socially deprived community? A longitudinal data analysis.

BACKGROUND: Socioeconomic deprivation is associated with inequalities in health care and outcomes. Despite concerns that the Quality and Outcomes Framework pay-for-performance scheme in the UK would exacerbate inequalities in primary care delivery, gaps closed over time. Local schemes were promoted as a means of improving clinical engagement by addressing local health priorities. We evaluated equity in achievement of target indicators and practice income for one local scheme. METHODS: We undertook a longitudinal survey over four years of routinely recorded clinical data for all 83 primary care practices. Sixteen indicators were developed that covered five local clinical and public health priorities: weight management; alcohol consumption; learning disabilities; osteoporosis; and chlamydia screening. Clinical indicators were logit transformed from a percentage achievement scale and modelled allowing for clustering of repeated measures within practices. This enabled our study of target achievements over time with respect to deprivation. Practice income was also explored. RESULTS: Higher practice deprivation was associated with poorer performance for five indicators: alcohol use registration (OR 0.97; 95 % confidence interval 0.96,0.99); recorded chlamydia test result (OR 0.97; 0.94,0.99); osteoporosis registration (OR 0.98; 0.97,0.99); registration of repeat prednisolone prescription (OR 0.98; 0.96,0.99); and prednisolone registration with record of dual energy X-ray absorptiometry (DEXA) scan/referral (OR 0.92; 0.86,0.97); practices in deprived areas performed better for one indicator (registration of osteoporotic fragility fracture (OR 1.26; 1.04,1.51). The deprivation-achievement gap widened for one indicator (registered females aged 65-74 with a fracture referred for a DEXA scan; OR 0.97; 0.95,0.99). Two other indicators indicated a similar trend over two years before being withdrawn (registration of fragility fracture and over-75 s with a fragility fracture assessed and treated for osteoporosis risk). For one indicator the deprivation-achievement gap reduced over time (repeat prednisolone prescription (OR 1.01; 1.01,1.01). Larger practices and those serving more affluent areas earned more income per patient than smaller practices and those serving more deprived areas (t = -3.99; p =0.0001). CONCLUSIONS: Any gaps in achievement between practices were modest but mostly sustained or widened over the duration of the scheme. Given that financial rewards may not reflect the amount of work undertaken by practices serving more deprived patients, future pay-for-performance schemes also need to address fairness of rewards in relation to workload.

How can we recognize continuous quality improvement?

OBJECTIVE: Continuous quality improvement (CQI) methods are foundational approaches to improving healthcare delivery. Publications using the term CQI, however, are methodologically heterogeneous, and labels other than CQI are used to signify relevant approaches. Standards for identifying the use of CQI based on its key methodological features could enable more effective learning across quality improvement (QI) efforts. The objective was to identify essential methodological features for recognizing CQI. DESIGN: Previous work with a 12-member international expert panel identified reliably abstracted CQI methodological features. We tested which features met rigorous a priori standards as essential features of CQI using a three-phase online modified-Delphi process. SETTING: Primarily United States and Canada. PARTICIPANTS: 119 QI experts randomly assigned into four on-line panels. INTERVENTION: Participants rated CQI features and discussed their answers using online, anonymous and asynchronous discussion boards. We analyzed ratings quantitatively and discussion threads qualitatively. Main outcome measure(s) Panel consensus on definitional CQI features. RESULTS: /st> Seventy-nine (66%) panelists completed the process. Thirty-three completers self-identified as QI researchers, 18 as QI practitioners and 28 as both equally. The features 'systematic data guided activities,' 'designing with local conditions in mind' and 'iterative development and testing' met a priori standards as essential CQI features. Qualitative analyses showed cross-cutting themes focused on differences between QI and CQI. CONCLUSIONS: We found consensus among a broad group of CQI researchers and practitioners on three features as essential for identifying QI work more specifically as 'CQI.' All three features are needed as a minimum standard for recognizing CQI methods.