A person-centred consultation intervention to improve shared decision-making about, and uptake of, osteoporosis medicines (iFraP): a pragmatic, parallel-group, individual randomised controlled trial protocol.

Background: Good quality shared decision-making (SDM) conversations involve people with, or at risk of osteoporosis and clinicians collaborating to decide, where appropriate, which evidence-based medicines best fit the person's life, beliefs, and values. We developed the improving uptake of Fracture Prevention drug treatments (iFraP) intervention comprising a computerised Decision Support Tool (DST), clinician training package and information resources, for use in UK Fracture Liaison Service consultations.Two primary objectives to determine (1) the effect of the iFraP intervention on patient-reported ease in decision-making about osteoporosis medicines, and (2) cost-effectiveness of iFraP intervention compared to usual NHS care. Secondary objectives are to determine the iFraP intervention effect on patient reported outcome and experience measures, clinical effectiveness (osteoporosis medicine adherence), and to explore intervention acceptability, mechanisms, and processes underlying observed effects, and intervention implementation. Methods: The iFraP trial is a pragmatic, parallel-group, individual randomised controlled trial in patients referred to a Fracture Liaison Service, with nested mixed methods process evaluation and health economic analysis. Participants aged ≥50 years (n=380) are randomised (1:1 ratio) to one of two arms: (1) iFraP intervention (iFraP-i) or (2) comparator usual NHS care (iFraP-u) and are followed up at 2-weeks and 3-months. The primary outcome is ease of decision-making assessed 2 weeks after the consultation using the Decisional Conflict Scale (DCS). The primary objectives will be addressed by comparing the mean DCS score in each trial arm (using analysis of covariance) for patients given an osteoporosis medicine recommendation, alongside a within-trial cost-effectiveness and value of information (VoI) analysis. Process evaluation data collection includes consultation recordings, semi-structured interviews, and DST analytics. Discussion: The iFraP trial will answer important questions about the effectiveness of the new 'iFraP' osteoporosis DST, coupled with clinician training, on SDM and informed initiation of osteoporosis medicines. Trial registration ISRCTN: 10606407, 21/11/2022 https://doi.org/10.1186/ISRCTN10606407.

Background: For people with osteoporosis, broken bones (called 'fragility fractures') can occur from low or no trauma and cause significant disability. Medicines can strengthen bone and lower the chance of fragility fractures. However, many people who experience a fragility fracture do not start or continue taking osteoporosis medicines. People commonly choose not to take osteoporosis medicines because they are unsure what medicines are for, confused about fracture 'risk' and/or worried about side-effects. To address this, we developed the 'iFraP intervention': 1. The iFraP 'decision-support tool': to support patients and healthcare professionals talk together to make decisions about medicines2. iFraP training for healthcare professionals to:a. use the tool in appointments with patientsb. give understandable, clear and consistent information c. listen to and address patient concerns This trial investigates whether the iFraP intervention makes decision-making about osteoporosis medicines easier, and whether it is cost-effective, acceptable and practical to deliver. Methods: 380 patients will take part who will be 50 years and older and referred to a fracture prevention service, because they have broken a bone. Patients taking part will be allocated to receive either a usual NHS appointment or an appointment using the iFraP intervention. Patients will complete a questionnaire before their appointment, and 2 weeks and 3 months afterwards. Some patients will be asked if they consent to have their appointment recorded and/or be interviewed, to understand how the decision-support tool is being used, and patient's views of the iFraP intervention. Outputs: If successful, the iFraP intervention will benefit patients and the NHS by helping patients make decisions about osteoporosis medicine. If the iFraP intervention increases the number of people with osteoporosis that start and continue taking osteoporosis medicines, iFraP will lower the number of future fractures, and reduce the negative outcomes that result from fractures (e.g. significant disability).

Effectiveness of pneumococcal vaccination in adults with common immune-mediated inflammatory diseases in the UK: a case-control study.

BACKGROUND: People with immune-mediated inflammatory disease are at increased risk of pneumococcal pneumonia. The effectiveness of pneumococcal vaccination in people with immune-mediated inflammatory diseases has not been evaluated. We investigated the effectiveness of pneumococcal vaccination in preventing morbidity and mortality associated with pneumonia in patients with immune-mediated inflammatory diseases. METHODS: In this matched case-control study, we used primary-care electronic health record data from the Clinical Practice Research Datalink Gold database in the UK, with linked hospitalisation and mortality data. Adults with incident common immune-mediated inflammatory diseases diagnosed between April 1, 1997, and Dec 31, 2019, were followed up from the first diagnosis date to the occurrence of an outcome or date of last follow-up. Cases (ie, those with an outcome of interest) were age-matched and sex-matched to up to ten contemporaneous controls by use of incidence density sampling. Outcomes were hospitalisation due to pneumonia, death due to pneumonia, or primary-care consultation for lower respiratory tract infection requiring antibiotics. We defined hospital admission for pneumonia using hospital discharge diagnoses, death due to pneumonia using death certification data, and lower respiratory tract infection as present when primary-care consultation and antibiotic prescription occurred on the same date. We used multivariable, unconditional, logistical regression and constructed three models to examine the association between pneumococcal vaccination as an exposure and each of the three outcomes. FINDINGS: The first nested case-control analysis included 12 360 patients (7326 [59·3%] women and 5034 [40·7%] men): 1884 (15·2%) who were hospitalised due to pneumonia and 10 476 (84·8%) who were not admitted to hospital due to pneumonia. The second analysis included 5321 patients (3112 [58·5%] women and 2209 [41·5%] men): 781 (14·7%) who died due to pneumonia and 4540 (85·3%) who were alive on the index date. The third analysis included 54 530 patients (33 605 [61·6%] women and 20 925 [38·4%] men): 10 549 (19·3%) with lower respiratory tract infection treated with antibiotics and 43 981 (80·7%) without infection. In the multivariable analysis, pneumococcal vaccination was negatively associated with hospitalisation due to pneumonia (adjusted odds ratio 0·70 [95% CI 0·60-0·81]), death due to pneumonia (0·60 [0·48-0·76]), and lower respiratory tract infection treated with antibiotics (0·76 [0·72-0·80]). INTERPRETATION: Pneumococcal vaccination is associated with protection against hospitalisation and death due to pneumonia in patients with immune-mediated inflammatory diseases, without apparent residual confounding. However, residual unmeasured confounding cannot be fully excluded in observational research, which includes nested case-control studies. These findings should also be corroborated with data from other countries, given that this study used UK-based data. FUNDING: National Institute for Health and Care Research.

The relationship between obesity and patient-reported outcome measures in people with polymyalgia rheumatica.

Objective: To examine the association between obesity and patient-reported outcome measures (PROMs) in a primary care-based cohort of people with PMR. Methods: The PMR Cohort Study recruited people with incident PMR from 382 general practices. Self-completed questionnaires (0, 12, 24 months) captured a range of PROMs for pain, stiffness, anxiety, depression, fatigue, function and quality of life, alongside data on BMI. People were categorized as underweight/normal weight (BMI < 25kg/m2), overweight (25-29.99 kg/m2) or obese (≥30 kg/m2). Piecewise, multilevel, linear mixed-effects regression models examined relationships between BMI categories and PROMs over time, adjusting for confounding variables. Chi-squared tests examined the relationship between obesity and glucocorticoid persistence. Results: 644 people with PMR were included. At baseline, 33.9% were normal/underweight, 40.6% overweight and 25.5% obese. Compared with normal/underweight people, those with obesity had significantly worse scores for the following: pain and stiffness at 12 months; fatigue at 12 and 24 months; depression at baseline; physical function at all time points; and quality of life at baseline and 12 months. They also had significantly smaller improvements in stiffness (1.13 units on an 11-point numeric rating scale; P = 0.001) and physical function (0.14 units measured using the modified Health Assessment Questionnaire; P = 0.025) between 0 and 12 months. BMI categories did not relate to persistent glucocorticoid use at 12 months (P = 0.110) or 24 months (P = 0.166). Conclusion: Obesity associates with poorer outcomes for a range of PROMs in people with PMR. Consideration should be given to providing weight management support to people with PMR and obesity.

Relationship between research activity and general practice performance: cross sectional and longitudinal analyses.

BACKGROUND: Research activity usually improves outcomes by being translated into practice. However, there is developing evidence that research activity itself may improve the overall performance of health care organisations. However, evidence that these relationships represent a causal impact of research activity is less clear. Additionally, the bulk of the existing evidence relates to hospital settings, and it is not known if those relationships would also be found in general practice, where most patient contacts occur. AIM: We sought to (a) test whether there were significant relationships between research activity in general practice and organisational performance (b) test whether those relationships were plausibly causal. DESIGN AND SETTING: We analysed national data between 2008 and 2019 using cross sectional and longitudinal analyses, on general practices in England. METHODS: We used cross-sectional, panel and instrumental variable analyses to explore relationships between research activity (including measures from the NIHR Clinical Research Network and the Royal College of General Practitioners) and practice performance (including clinical quality of care, patient reported experience of care, prescribing quality and hospital admissions) Results: In cross-sectional analyses, research activity was positively associated with several measures of practice performance, including clinical quality of care, patient reported experience of care, and reduced hospital admissions. The associations were generally modest in magnitude. However, longitudinal analyses did not support a reliable causal relationship. CONCLUSION: Similar to findings from hospital settings, research activity in general practice is associated with practice performance. There is less evidence that research is causing those improvements, although this may reflect the limited level of research activity in most practices. We identified no negative impacts, suggesting that research activity is a potential marker of quality and something that high quality practices can deliver alongside their core responsibilities.

Uptake, safety and effectiveness of inactivated influenza vaccine in inflammatory bowel disease: a UK-wide study.

OBJECTIVE: To investigate (1) the UK-wide inactivated influenza vaccine (IIV) uptake in adults with inflammatory bowel disease (IBD), (2) the association between vaccination against influenza and IBD flare and (3) the effectiveness of IIV in preventing morbidity and mortality. DESIGN: Data for adults with IBD diagnosed before the 1 September 2018 were extracted from the Clinical Practice Research Datalink Gold. We calculated the proportion of people vaccinated against seasonal influenza in the 2018-2019 influenza cycle. To investigate vaccine effectiveness, we calculated the propensity score (PS) for vaccination and conducted Cox proportional hazard regression with inverse-probability treatment weighting on PS. We employed self-controlled case series analysis to investigate the association between vaccination and IBD flare. RESULTS: Data for 13 631 people with IBD (50.4% male, mean age 52.9 years) were included. Fifty percent were vaccinated during the influenza cycle, while 32.1% were vaccinated on time, that is, before the seasonal influenza virus circulated in the community. IIV was associated with reduced all-cause mortality (aHR (95% CI): 0.73 (0.55,0.97) but not hospitalisation for pneumonia (aHR (95% CI) 0.52 (0.20-1.37), including in the influenza active period (aHR (95% CI) 0.48 (0.18-1.27)). Administration of the IIV was not associated with IBD flare. CONCLUSION: The uptake of influenza vaccine was low in people with IBD, and the majority were not vaccinated before influenza virus circulated in the community. Vaccination with the IIV was not associated with IBD flare. These findings add to the evidence to promote vaccination against influenza in people with IBD.

Exploring practice and perspectives on shared decision-making about osteoporosis medicines in Fracture Liaison Services: the iFraP development qualitative study.

Interviews and focus groups with patients, FLS clinicians, and GPs identified challenges relating to clinical and shared decision-making about bone health and osteoporosis medicines. Findings will inform the development of the multicomponent iFraP intervention to address identified training needs and barriers to implementation to facilitate SDM about osteoporosis medicines. PURPOSE: The iFraP (improving uptake of Fracture Prevention treatments) study aimed to develop a multicomponent intervention, including an osteoporosis decision support tool (DST), to support shared decision-making (SDM) about osteoporosis medicines. To inform iFraP intervention development, this qualitative study explored current practice in relation to communication about bone health and osteoporosis medicines, anticipated barriers to, and facilitators of, an osteoporosis DST, and perceived training needs. METHODS: Patients attending an FLS consultation (n = 8), FLS clinicians (n = 9), and general practitioners (GPs; n = 7) were purposively sampled to participate in a focus group and/or telephone interview. Data were transcribed, inductively coded, and then mapped to the Theoretical Domains Framework (TDF) as a deductive framework to systematically identify possible barriers to, and facilitators of, implementing a DST. RESULTS: Inductive codes were deductively mapped to 12 TDF domains. FLS clinicians were perceived to have specialist expertise (knowledge). However, clinicians described aspects of clinical decision-making and risk communication as difficult (cognitive skills). Patients reflected on decisional uncertainty about medicines (decision processes). Discussions about current practice and the proposed DST indicated opportunities to facilitate SDM, if identified training needs are met. Potential individual and system-level barriers to implementation were identified, such as differences in FLS configuration and a move to remote consulting (environmental context and resources). CONCLUSIONS: Understanding of current practice revealed unmet training needs, indicating that using a DST in isolation would be unlikely to produce a sustained shift to SDM. Findings will shape iFraP intervention development to address unmet needs.

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot.

INTRODUCTION AND OBJECTIVES: There is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) versus enhanced treatment as usual (ETAU) in improving depressive symptoms in people with TB and comorbid depression, enhancing adherence with anti-TB treatment (ATT) and its implementation in the real-world setting of Pakistan. METHODS: We will conduct a pragmatic parallel arm randomised control trial with an internal pilot. A brief psychological intervention based on CBT has been developed using a combination of qualitative and ethnographic studies. The inbuilt pilot trial will have a sample size of 80, while we plan to recruit 560 (280 per arm) participants in the definitive trial. Participants who started on ATT within 1 month of diagnosis for pulmonary and extrapulmonary TB or multidrug resistant TB (MDR-TB) and meeting the criteria for depression on Patient Health Questionnaire-9 (PHQ-9) will be randomised with 1:1 allocation to receive six sessions of CBT (delivered by TB healthcare workers) or ETAU. Data on the feasibility outcomes of the pilot will be considered to proceed with the definitive trial. Participants will be assessed (by a blinded assessor) for the following main trial primary outcomes: (1) severity of depression using PHQ-9 scale (interviewer-administered questionnaire) at baseline, weeks 8, 24 and 32 postrandomisation and (2) ATT at baseline and week 24 at the end of ATT therapy. ETHICS AND DISSEMINATION: Ethical approval has been obtained from Keele University Research Ethics Committee (ref: 2023-0599-792), Khyber Medical University Ethical Review Board (ref: DIR/KMU-EB/CT/000990) and National Bioethics Committee Pakistan (ref: No.4-87/NBC-998/23/587). The results of this study will be reported in peer-reviewed journals and academic conferences and disseminated to stakeholders and policymakers. TRIAL REGISTRATION NUMBER: ISRCTN10761003.

Acceptability of a proposed practice pharmacist-led review for opioid-treated patients with persistent pain: A qualitative study to inform intervention development.

Introduction: Regular review of patients prescribed opioids for persistent non-cancer pain (PCNP) is recommended but not routinely undertaken. The PROMPPT (Proactive clinical Review of patients taking Opioid Medicines long-term for persistent Pain led by clinical Pharmacists in primary care Teams) research programme aims to develop and test a pharmacist-led pain review (PROMPPT) to reduce inappropriate opioid use for persistent pain in primary care. This study explored the acceptability of the proposed PROMPPT review to inform early intervention development. Methods: Interviews (n = 15) and an online discussion forum (n = 31) with patients prescribed opioids for PCNP and interviews with pharmacists (n = 13), explored acceptability of a proposed PROMPPT review. A prototype PROMPPT review was then tested and refined through 3 iterative cycles of in-practice testing (IPT) (n = 3 practices, n = 3 practice pharmacists, n = 13 patients). Drawing on the Theoretical Framework of Acceptability (TFA), a framework was generated (including a priori TFA constructs) allowing for deductive and inductive thematic analysis to identify aspects of prospective and experienced acceptability. Results: Patients felt uncertain about practice pharmacists delivering the proposed PROMPPT review leading to development of content for the invitation letter for IPT (introducing the pharmacist and outlining the aim of the review). After IPT, patients felt that pharmacists were suited to the role as they were knowledgeable and qualified. Pharmacists felt that the proposed reviews would be challenging. Although challenges were experienced during delivery of PROMPPT reviews, pharmacists found that they became easier to deliver with time, practise and experience. Recommendations for optimisations after IPT included development of the training to include examples of challenging consultations. Conclusions: Uptake of new healthcare interventions is influenced by perceptions of acceptability. Exploring prospective and experienced acceptability at multiple time points during early intervention development, led to mini-optimisations of the prototype PROMPPT review ahead of a non-randomised feasibility study.

2023 EULAR classification criteria for hand osteoarthritis.

OBJECTIVES: The objective of this study is to develop classification criteria for overall hand osteoarthritis (OA), interphalangeal OA and thumb base OA based on self-reported data and radiographic features. METHODS: The classification criteria sets were developed in three phases. In phase 1, we identified criteria that discriminated hand OA from controls. In phase 2, we used a consensus-based decision analysis approach to derive a clinician-based evaluation of the relative importance of the criteria. In phase 3, we refined the scoring system, determined the cut-offs for disease classification and compared the sensitivity and specificity of the European Alliance of Associations for Rheumatology (EULAR) criteria with the 1990 American College of Rheumatology (ACR) criteria. RESULTS: In persons with hand symptoms and no other disease (including psoriasis) or acute injury that can explain the hand symptoms (mandatory criteria), hand OA can be classified based on age, duration of morning stiffness, number of joints with osteophytes and joint space narrowing, and concordance between symptoms and radiographic findings. Using a sum of scores based on each diagnostic element, overall hand OA can be classified if a person achieves 9 or more points on a 0-15 scale. The cut-off for interphalangeal OA and thumb base OA is 8 points. While the EULAR criteria demonstrated better sensitivity than the ACR criteria in the phase 1 data set, the performance of the two criteria sets was similar in two external cohorts. CONCLUSIONS: International experts developed the EULAR criteria to classify overall hand OA, interphalangeal OA and thumb base OA in clinical studies using a rigorous methodology.

Designing a primary care pharmacist-led review for people treated with opioids for persistent pain: a multi-method qualitative study.

BACKGROUND: Opioids are frequently prescribed for persistent non-cancer pain despite limited evidence of long-term effectiveness and risk of harm. Evidence-based interventions to address inappropriate opioid prescribing are lacking. AIM: To explore perspectives of people living with persistent pain to understand barriers and facilitators in reducing opioids in the context of a pharmacist-led primary care review, and identify review components and features for optimal delivery. DESIGN & SETTING: A multi-method qualitative study undertaken in the primary care setting in the UK. METHOD: Adults with experience of persistent pain and taking opioids participated in semi-structured interviews (n = 15, 73% female) and an online discussion forum (n = 31). The Theoretical Domains Framework (TDF) provided a framework for data collection and thematic analysis, involving deductive analysis to TDF domains, inductive analysis within domains to generate sub-themes, and sub-theme comparison to form across-domain overarching themes. The behaviour change technique taxonomy (v1) and motivational behaviour change technique classification system were used to systematically map themes to behaviour change techniques to identify potential review components and delivery features. RESULTS: Thirty-two facilitator and barrier sub-themes for patients reducing opioids were identified across 13 TDF domains. These combined into the following six overarching themes: learning to live with pain; opioid reduction expectations; assuming a medical model; pharmacist-delivered reviews; pharmacist-patient relationship; and patient engagement. Sub-themes mapped to 21 unique behaviour change techniques, yielding 17 components and five delivery features for the proposed PROMPPT review. CONCLUSION: This study generated theoretically informed evidence for design of a practice pharmacist-led PROMPPT review. Future research will test the feasibility and acceptability of the PROMPPT review and pharmacist training.

Indirect impact of the war in Ukraine on primary percutaneous coronary intervention for ST-segment elevation myocardial infarction in Poland.

INTRODUCTION: The Russian invasion of Ukraine in February 2022 resulted in displacement of approximately 12.5 million refugees to adjacent countries, including Poland, which may have strained health care service delivery. OBJECTIVES: Using the ST­segment elevation myocardial infarction (STEMI) data, we aimed to evaluate whether the Russian invasion of Ukraine has indirectly impacted delivery of acute cardiovascular care in Poland. PATIENTS AND METHODS: We analyzed all adult patients undergoing percutaneous coronary interventions (PCIs) for STEMI across Poland between February 25, 2017 and May 24, 2022. The investigated health care centers were allocated to regions below and over 100 km from the Polish-Ukrainian border. Mixed­effect generalized linear regression models with random effects per hospital were used to explore the associations between the war in Ukraine and several parameters, and whether these associations differed across the regions below and over 100 km from the border. RESULTS: A total of 90 115 procedures were included in the analysis. The average number of procedures per month was similar to the predicted volume for centers over 100 km from the border, while it was higher than expected (by an estimated median of 15 [interquartile range, 11-19]) for the region below 100 km from the border. There was no difference in adjusted fatality rate or quality of care outcomes for pre- and during­war time in both regions, with no evidence of a difference­in­difference across the regions. CONCLUSIONS: Following the Russian invasion of Ukraine, there was only a modest and temporary increase in the number of primary PCIs, predominantly in the centers situated within 100 km of the Polish-Ukrainian border, although no significant impact on in­hospital fatality rate was found.

Health literacy and gout characteristics in a primary care cohort.

Objectives: To examine the cross-sectional association between health literacy and gout characteristics. Methods: In a primary care cohort of adults living with gout, the prevalence of poor health literacy was defined using the Single-Item Literacy Screener (SILS). Multiple logistic regression was used to obtain adjusted odds ratios (ORs) for the cross-sectional associations between health literacy and individual gout characteristics (frequency of flares, age at gout onset, history of oligo-/polyarticular flares, allopurinol use, allopurinol dose and serum urate level) with 95% CIs and adjustment for age, sex, deprivation and further education. Results: Of 551 participants [mean age 54.4 years (s.d. 11.2), 498 (90.4%) male], 163 (30.1%) reported two or more flares in the previous 12 months. Fifty-one (9.4%) had poor health literacy. Poor health literacy was associated with having two or more flares in the preceding 12 months [adjusted OR 4.10 (95% CI 2.04, 8.19)] and a history of oligo-/polyarticular flares [OR 1.93 (95% CI 1.06, 3.55)]. No associations were identified between health literacy and age at gout onset [OR 0.99 (95% CI 0.96, 1.01)], allopurinol use [OR 0.88 (95% CI 0.46, 1.65)] or dose [OR 1.00 OR (95% CI 1.00, 1.00)] or serum urate [most recent serum urate OR 1.0 (95% CI 1.00, 1.00)]. Conclusions: Frequent flares and a history of oligo-/polyarticular flares were associated with poor health literacy. Since health literacy is an important determinant of health outcomes, it is important to consider health literacy when providing information and education to people with gout.

Risk of adverse outcomes during gabapentinoid therapy and factors associated with increased risk in UK primary care using the clinical practice research datalink: a cohort study.

ABSTRACT: Growing evidence from pharmacovigilance data and postmortem toxicology reports highlights the misuse potential of gabapentinoids. This study aimed to investigate the risk of serious adverse outcomes (drug misuse, overdose, major trauma), and their risk factors, in primary care patients who are prescribed gabapentinoids. Using the UK Clinical Practice Research Datalink, a matched cohort study calculated adverse event rates separately for gabapentinoid-exposed and unexposed cohorts. In the exposed cohort, event rates for exposure to a range of potential risk factors were calculated. Event rates were compared using Cox proportional hazards models, adjusted for age, sex, deprivation, previous mental health diagnosis, and coprescribing with potentially interacting medicines. Substance misuse (gabapentin adjusted hazard ratio [95% CI]: 2.40 [2.25-2.55]), overdose (2.99 [2.56-3.49]), and major trauma (0-2.5 years: 1.35 [1.28-1.42]; 2.5 to 10 years: 1.73 [1.56-1.95]) were more common among patients prescribed gabapentinoids than matched individuals who were not. The association with overdose was stronger for pregabalin than gabapentin. All adverse outcomes were significantly associated with smoking, history of substance misuse, overdose, or a mental health condition and prescription of opioids, benzodiazepines, antidepressants, and Z-drug hypnotics (eg, gabapentin hazard ratios for association of concurrent opioid use: misuse 1.49 [1.47-1.51]; overdose 1.87 [1.78-1.96]; major trauma 1.28 [1.26-1.30]). Our findings highlight the importance of careful patient selection when prescribing gabapentinoids and the need to educate prescribers about the risks of these drugs, particularly in combination with other central nervous system depressants.

Identifying carers in general practice (STATUS QUO): a multicentre, cross-sectional study in England.

OBJECTIVES: To determine General Practice (GP) recording of carer status and the number of patients self-identifying as carers, while self-completing an automated check-in screen prior to a GP consultation. DESIGN: A descriptive cross-sectional study. SETTING: 11 GPs in the West Midlands, England. Recruitment commenced in September 2019 and concluded in January 2020. PARTICIPANTS: All patients aged 10 years and over, self-completing an automated check-in screen, were invited to participate during a 3-week recruitment period. PRIMARY AND SECONDARY OUTCOME MEASURES: The current coding of carers at participating GPs and the number of patients identifying themselves as a carer were primary outcome measures. Secondary outcome measures included the number of responses attained from automated check-in screens as a research data collection tool and whether carers felt supported in their carer role. RESULTS: 80.3% (n=9301) of patients self-completing an automated check-in screen participated in QUantifying the identification Of carers in general practice (STATUS QUO Study) (62.6% (n=5822) female, mean age 52.9 years (10-98 years, SD=20.3)). Prior to recruitment, the clinical code used to denote a carer was identified in 2.7% (n=2739) of medical records across the participating GPs.10.1% (n=936) of participants identified themselves as a carer. They reported feeling supported with their own health and social care needs: always 19.3% (n=150), a lot of the time 13.2% (n=102), some of the time 40.8% (n=317) and never 26.7% (n=207). CONCLUSIONS: Many more participants self-identified as a carer than were recorded on participating GP lists. Improvements in the recording of the population's caring status need to be actioned, to ensure that supportive implementation strategies for carers are effectively received. Using automated check-in facilities for research continues to provide high participation rates.

Characteristics of primary care practices associated with patient education during COVID-19: results of the cross-sectional PRICOV-19 study in 38 countries.

BACKGROUND: In response to the COVID-19 pandemic, the World Health Organization established a number of key recommendations such as educational activities especially within primary care practices (PCPs) which are a key component of this strategy. This paper aims to examine the educational activities of PCPs during COVID-19 pandemic and to identify the factors associated with these practices across 38 countries. METHODS: A "Patient Education (PE)" score was created based on responses to six items from the self-reported questionnaire among PCPs (n = 3638) compiled by the PRICOV-19 study. Statistical analyses were performed on 3638 cases, with PCPs with missing PE score values were excluded. RESULTS: The PE score features a mean of 2.55 (SD = 0.68) and a median of 2.50 (2.16 - 3.00), with a maximum of 4.00, and varies quite widely between countries. Among all PCPs characteristics, these factors significantly increase the PE score: the payment system type (with a capitation payment system or another system compared to the fee for service), the perception of average PCP with patients with chronic conditions and the perception of adequate governmental support. CONCLUSION: The model presented in this article is still incomplete and requires further investigation to identify other configuration elements favorable to educational activities. However, the results already highlight certain levers that will enable the development of this educational approach appropriate to primary care.

Prognostic factors for colchicine prophylaxis-related adverse events when initiating allopurinol for gout: retrospective cohort study.

OBJECTIVES: Colchicine is commonly used to prevent flares when starting urate-lowering therapy for gout. Patients with gout are frequently concurrently prescribed other medications (such as statins) that may interact with colchicine, increasing the risk of adverse events. The aim of this study was to describe potential prognostic factors for adverse events in patients prescribed colchicine when initiating allopurinol. METHODS: We conducted a retrospective cohort study in linked UK Clinical Practice Research Datalink and Hospital Episode Statistics datasets. Adults initiating allopurinol for gout with colchicine (01/04/1997-30/11/2016) were included. Potential prognostic factors were defined, and the likelihood of adverse events, including diarrhoea, nausea or vomiting, myocardial infarction (MI), neuropathy, myalgia, myopathy, rhabdomyolysis, and bone marrow suppression, were estimated. RESULTS: From 01/04/1997-30/11/2016, 13 945 people with gout initiated allopurinol with colchicine prophylaxis (mean age 63.9 (SD 14.7) years, 78.2% male). One quarter (26%, 95% CI 25% to 27%) were prescribed ≥1 potentially interacting medicines, most commonly statins (21%, 95% CI 20% to 22%). Statins were not associated with increased adverse events, although other drugs were associated with some adverse outcomes. Diarrhoea and MI were associated with more comorbidities and more severe CKD. CONCLUSION: People were given colchicine prophylaxis despite commonly having preexisting prescriptions for medications with potential to interact with colchicine. Adverse events were more common in people who had more comorbidities and certain potentially interacting medications. Our findings will provide much-needed information about prognostic factors for colchicine-related adverse events that can inform treatment decisions about prophylaxis when initiating allopurinol.

Impact of research activity on performance of general practices: a qualitative study.

BACKGROUND: There is evidence that engaging in research is directly associated with better performance. If this relationship is to be strengthened, it is necessary to understand the mechanisms which might underlie that relationship. AIM: To explore the perspectives of staff and wider stakeholders about mechanisms by which research activity might impact on the performance of general practices. DESIGN & SETTING: Qualitative study using semi-structured interviews with general practice professionals and wider stakeholders in England. METHOD: Individual interviews with 41 purposively sampled staff in 'research ready' or 'research active' general practices and 21 other stakeholders. Interviews were independently coded by three researchers using a Framework approach. RESULTS: Participants described potential 'direct' and 'indirect' impacts on their work. 'Direct' impacts included research changing practice work (eg, additional records searches for particular conditions), bringing in additional resources (eg, access to investigations or staff) and improving relationships with patients. 'Indirect' impacts included job satisfaction (eg, perception of practice as a centre of excellence and innovation, and the variety afforded by research activity reducing burnout) and staff recruitment (increasing the attractiveness of the practice as a place to work). Respondents identified few negative impacts. CONCLUSIONS: Staff and stakeholders identified a range of potential impacts of research activity on practice performance, with impacts on their working lives most salient. Negative impacts were not generally raised. Nevertheless, respondents generally discussed potential impacts rather than providing specific examples of those impacts. This may reflect the type of research activity conducted in general practice, often led by external collaborators.

Systematic Review of the Association of the Hospital Frailty Risk Score with Mortality in Patients with Cerebrovascular and Cardiovascular Disease.

BACKGROUND: There is limited systematic data on the association between the Hospital Frailty Risk Score (HFRS) and characteristics and mortality in patients with cerebrovascular and cardiovascular disease (CVD). This systematic review aimed to summarise the use of the HFRS in describing the prevalence of frailty in patients with CVD, the clinical characteristics of patients with CVD, and the association between frailty on the likelihood of mortality in patients with CVD. METHODS: A systematic literature search for observational studies using terms related to CVD, cerebrovascular disease, and the HFRS was conducted using 6 databases in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were appraised using the Newcastle-Ottawa Scale (NOS). RESULTS: Seventeen observational studies were included, all rated 'good' quality according to the NOS. One study investigated 5 different CVD cohorts (atrial fibrillation (AF), heart failure (HF), hypotension, hypertension, and chronic ischemic heart disease), 1 study investigated 2 different CVD cohorts (AF and acute myocardial infarction (AMI)), 6 studies investigated HF, 3 studies investigated AMI, 4 studies investigated stroke, 1 study investigated AF, and 1 study investigated cardiac arrest. Increasing frailty risk category was associated with increased age, female sex, and non-white racial group across all CVD. Increasing frailty risk category is also associated with increased length of hospital stay, total costs, and increased odds of 30-day all-cause mortality across all CVD. CONCLUSIONS: The HFRS is an efficient and effective tool for stratifying frailty in patients with CVD and predicting adverse health outcomes.

"We have to change our mindsets": a qualitative study of barriers and facilitators in research collaboration across integrated care system organisations.

The introduction of Integrated Care Systems (ICS) in England aimed to increase joint planning and delivery of health and social care, and other services, to better meet the needs of local communities. There is an associated duty to undertake collaborative research across ICS partners to inform this new integrated approach, which might be challenging given that organisations span health, local authority, voluntary and community sector, and research. This study aimed to explore the appetite for collaborative Research and Innovation (R&I) across ICSs, potential barriers and solutions. This qualitative study involved semi-structured interviews with 24 stakeholders who held senior positions within organisations across two ICS areas (Staffordshire and Stoke-on-Trent; Shropshire, Telford and Wrekin). Interview transcripts were analysed using inductive and deductive analysis, first mapping to the Theoretical Domains Framework (TDF), then considering key influences on organisational behaviour in terms of Capability, Opportunity and Motivation from the COM-B Behaviour Change Wheel. There were fundamental limitations on organisational opportunities for collaborative R&I: a historical culture of competition (rather than collaboration), a lack of research culture and prioritisation, compounded by a challenging adverse economic environment. However, organisations were motivated to undertake collaborative R&I. They recognised the potential benefits (e.g., skill-sharing, staff development, attracting large studies and funding), the need for collaborative research that mirrors integrated care, and subsequent benefits for care recipients. Related barriers included negative experiences of collaboration, fear of failing and low confidence. Capability varied across organisations in terms of research skills and confidence, which reflected the range of partners (from local authorities to NHS Trusts, primary care, and academic institutions). These findings indicate a need to shift from a culture of competition to collaboration, and to help organisations across ICS to prioritise research, and share resources and skills to mitigate the limiting effects of a constrained economic environment. This could be further explored using a systems change approach, to develop the collaborative research efforts alongside the overarching move towards integrated care.

Risk-stratified monitoring for sulfasalazine toxicity: prognostic model development and validation.

BACKGROUND: Sulfasalazine-induced cytopenia, nephrotoxicity and hepatotoxicity is uncommon during long-term treatment. Some guidelines recommend 3 monthly monitoring blood tests indefinitely during long-term treatment while others recommend stopping monitoring after 1 year. To rationalise monitoring, we developed and validated a prognostic model for clinically significant blood, liver or kidney toxicity during established sulfasalazine treatment. DESIGN: Retrospective cohort study. SETTING: UK primary care. Data from Clinical Practice Research Datalink Gold and Aurum formed independent development and validation cohorts. PARTICIPANTS: Age ≥18 years, new diagnosis of an inflammatory condition and sulfasalazine prescription. STUDY PERIOD: 1 January 2007 to 31 December 2019. OUTCOME: Sulfasalazine discontinuation with abnormal monitoring blood-test result. ANALYSIS: Patients were followed up from 6 months after first primary care prescription to the earliest of outcome, drug discontinuation, death, 5 years or 31 December 2019. Penalised Cox regression was performed to develop the risk equation. Multiple imputation handled missing predictor data. Model performance was assessed in terms of calibration and discrimination. RESULTS: 8936 participants were included in the development cohort (473 events, 23 299 person-years) and 5203 participants were included in the validation cohort (280 events, 12 867 person-years). Nine candidate predictors were included. The optimism adjusted R2 D and Royston D statistic in the development data were 0.13 and 0.79, respectively. The calibration slope (95% CI) and Royston D statistic (95% CI) in validation cohort was 1.19 (0.96 to 1.43) and 0.87 (0.67 to 1.07), respectively. CONCLUSION: This prognostic model for sulfasalazine toxicity uses readily available data and should be used to risk-stratify blood-test monitoring during established sulfasalazine treatment.