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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
Opt-in versus universal codeine provision for medical abortion up to 10 weeks of gestation at British Pregnancy Advisory Service: a cross-sectional evaluation
ObjectiveTo assess patient experiences of pain management during medical abortion up to 10 weeks’ gestation with opt-in versus universal codeine provision.MethodsWe invited patients who underwent medical abortion up to 10 weeks of gestation to participate in an online, anonymous, English-language survey from November 2021 to March 2022. We performed ordinal regression analyses to compare satisfaction with pain management (5-point Likert scale) and maximum abortion pain score (11-point numerical rating scale) in the opt-in versus universal codeine provision groups.ResultsOf 11 906 patients invited to participate, 1625 (13.6%) completed the survey. Participants reported a mean maximum pain score of 6.8±2.2. A total of 1149 participants (70.7%) reported using codeine for pain management during their abortion. Participants in the opt-in codeine provision group were significantly more likely to be satisfied with their pain management than those in the universal group (aOR 1.48, 95% CI 1.12 to 1.96, p<0.01). Maximum abortion pain scores were lower on average among the opt-in codeine provision group (OR 0.80, 95% CI 0.66 to 0.96, p=0.02); however, this association was not statistically significant in the model adjusted for covariates (aOR 0.85, 95% CI 0.70 to 1.03, p=0.09).ConclusionOur findings suggest that patients have a better experience with pain management during medical abortion when able to opt-in to codeine provision following counselling versus receiving this medication routinely.
Framework for understanding movement and physical activity in patients diagnosed with psychosis.
BACKGROUND: Patients diagnosed with psychosis often spend less time than others engaged in exercise and more time sitting down, which likely contributes to poorer physical and mental health. OBJECTIVE: The aim of this study was to develop a comprehensive framework from the perspective of patients, carers, and staff for understanding what promotes movement and physical activity. METHODS: A critical realist approach was taken to design the study. Interviews (n=23) and focus groups (n=12) were conducted with (1) outpatients aged 16 years or older diagnosed with psychosis, and under the care of a mental health team, (2) carers and (3) mental health staff working in the community. Purposive sampling was used to maximise variation in participant characteristics. Data were analysed using reflexive thematic analysis. FINDINGS: 19 patients (9 women and 10 men, mean age=45·0 (SD=12·2) years, 15 White British, 2 Black African, 1 Pakistani and 1 other ethnic group), 14 carers (11 women and 3 men, mean age=59·9 (SD=12·7) years, 13 White British and 1 Asian) and 18 staff (14 women and 4 men, mean age=38·7 (SD=12·3) years, 15 White British, 1 White other, 1 Asian Bangladeshi and 1 other Asian) participated in the study. Five factors were found to promote movement and physical activity. Patients must be able to find a purpose to moving which is meaningful to them (Factor 1: Purpose). Patients need to have an expectation of the positive consequences of movement and physical activity, which can be influenced by others' expectations (Factor 2: Predictions). A patient's current physical (eg, pain) and emotional state (eg, distress about voices) needs to be addressed to allow movement and physical activity (Factor 3: Present state). Movement and physical activity can also be encouraged by the availability of effective and tailored support, provided by engaged and supported people (Factor 4: Provision). Finally, through the identification and interruption of vicious cycles (eg, between inactivity and mood states) more positive cycles can be put in place (Factor 5: Process). CONCLUSIONS AND CLINICAL IMPLICATIONS: The 5 P (Purpose, Predictions, Present state, Provision and Process Physical Activity Framework) for understanding movement and physical activity for people diagnosed with psychosis has the potential to inform future research and guide interventions. A checklist is provided for clinicians to help foster change in activity levels.
Clinical and cost-effectiveness of DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives) for people living with dementia and their carers: a study protocol for a parallel multicentre randomised controlled trial.
INTRODUCTION: Many people living with dementia experience sleep disturbance and there are no known effective treatments. Non-pharmacological treatment options should be the first-line sleep management. For family carers, relatives' sleep disturbance leads to interruption of their sleep, low mood and breakdown of care. Our team developed and delivered DREAMS START (Dementia RElAted Manual for Sleep; STrAtegies for RelaTives), a multimodal non-pharmacological intervention, showing it to be feasible and acceptable. The aim of this randomised controlled trial is to establish whether DREAMS START is clinically cost-effective in reducing sleep disturbances in people living with dementia living at home compared with usual care. METHODS AND ANALYSIS: We will recruit 370 participant dyads (people living with dementia and family carers) from memory services, community mental health teams and the Join Dementia Research Website in England. Those meeting inclusion criteria will be randomised (1:1) either to DREAMS START or to usual treatment. DREAMS START is a six-session (1 hour/session), manualised intervention delivered every 1-2 weeks by supervised, non-clinically trained graduates. Outcomes will be collected at baseline, 4 months and 8 months with the primary outcome being the Sleep Disorders Inventory score at 8 months. Secondary outcomes for the person with dementia (all proxy) include quality of life, daytime sleepiness, neuropsychiatric symptoms and cost-effectiveness. Secondary outcomes for the family carer include quality of life, sleep disturbance, mood, burden and service use and caring/work activity. Analyses will be intention-to-treat and we will conduct a process evaluation. ETHICS AND DISSEMINATION: London-Camden & Kings Cross Ethics Committee (20/LO/0894) approved the study. We will disseminate our findings in high-impact peer-reviewed journals and at national and international conferences. This research has the potential to improve sleep and quality of life for people living with dementia and their carers, in a feasible and scalable intervention. TRIAL REGISTRATION NUMBER: ISRCTN13072268.
Clinical trials of pharmacological interventions for SARS-CoV-2 published in leading medical journals report adherence but not how it was assessed
Aims: Adherence to pharmacological interventions in clinical trials is crucial for accurate identification of beneficial and adverse outcomes. The ways in which adherence to interventions should be reported in trial publications are described in the Template for Intervention Description and Replication (TIDieR), a 12-item extension of the Consolidated Standards of Reporting Trials reporting guidelines. The objective of this study was to assess compliance with TIDieR Items 11 and 12 of randomized controlled trials (RCTs) of interventions in SARS-CoV-2 infection published in 5 selected journals during 2021. Methods: We assessed pharmacological interventions for SARS-CoV-2 infection reported in RCTs published in 2021 in the Annals of Internal Medicine, The BMJ, JAMA, The Lancet and The New England Journal for Medicine for compliance with TIDieR items addressing intervention adherence (Items 11 and 12). We calculated proportional adherence for pharmacological and comparator interventions where available. Results: We found 75 eligible RCTs. Twenty-eight (37%) reported results of SARS-CoV-2 vaccinations. Compliance with Items 11 and 12 could be assessed in 71 of these 75. Of the 71 RCTs, 37 (52%) reported how adherence was assessed (Item 11), and 70 reported adherence rates (Item 12). Only 1 of the 71 RCTs (1.4%, 0–7.6%) fully complied with TIDieR Items 11 and 12. Conclusion: Half of RCTs of SARS-CoV-2 pharmacological interventions published in leading medical journals in 2021 complied with reporting of how adherence assessments were made and almost none complied with both TIDieR Items 11 and 12. The implications for interpretation, application and replication of findings based on these publications warrant consideration.
Safety of direct-acting oral anticoagulant (DOAC) prescribing: OpenSAFELY-TPP analysis of 20.5 million adults' electronic health records.
BACKGROUND: During the COVID-19 pandemic many patients were switched from warfarin to DOACs which require the creatinine clearance calculated to ensure the correct dose is prescribed to avoid bleeding or reduced efficacy. AIM: To identify the study population proportion prescribed a DOAC. Of these, the proportion with recorded: weight, estimated Glomerular Filtration Rate (eGFR), creatinine, creatinine clearance (CrCl) and atrial fibrillation (AF). To analyse the proportion of patients with recorded AF and CrCl prescribed a recommended DOAC dose. DESIGN & SETTING: A retrospective cohort study of 20.5 million adult NHS patients' electronic health records (EHRs) in England in the OpenSAFELY-TPP platform (January 2018 to February 2023). METHOD: Patients on DOACs were analysed for age, sex, recorded weight, eGFR, creatinine, CrCl and AF. Prescribed DOAC doses in patients with recorded AF were compared to recommended doses for recorded CrCl and determined as either recommended, underdose or overdose. RESULTS: In February 2023, weight, eGFR, creatinine, CrCl, AF and, AF and CrCl were recorded in 72.8%; 92.4%; 94.3%; 73.5%; 73.9% of study population respectively. Both AF and CrCl were recorded for 56.7% of patients. Of these, 86.2% received the recommended and 13.8% non-recommended DOAC doses. CONCLUSIONS: CrCl is not recorded for a substantial number of patients on DOACs. We recommend that national organisations tasked with safety, collectively update guidance on the appropriate weight to use in the Cockcroft-Gault equation, clarify that CrCl is not equivalent to eGFR and work with GP clinical system suppliers to standardise the calculation of CrCl in the EHR.
What does social prescribing look like in practice? A qualitative case study informed by practice theory.
Social prescribing (SP) typically involves linking patients in primary care with a range of local, community-based, non-clinical services. While there is a growing body of literature investigating the effectiveness of SP in improving healthcare outcomes, questions remain about how such outcomes are achieved within the everyday complexity of community health systems. This qualitative case study, informed by practice theory, aimed to investigate how SP practices relevant to people at high risk of type 2 diabetes (T2D) were enacted in a primary care and community setting serving a multi-ethnic, socioeconomically deprived population. We collected different types of qualitative data, including 35 semi-structured interviews with primary care clinicians, link workers and SP organisations; 30 hours of ethnographic observations of community-based SP activities and meetings; and relevant documents. Data analysis drew on theories of social practice, including Feldman's (2000) notion of the organisational routine, which emphasises the creative and emergent nature of routines in practice. We identified different, overlapping ways of practising SP: from highly creative, reflective and adaptive ('I do what it takes'), to more constrained ('I do what I can') or compliant ('I do as I'm told') approaches. Different types of practices were in tension and showed varying degrees of potential to support patients at high risk of T2D. Opportunities to adapt, try, negotiate, and ultimately reinvent SP to suit patients' own needs facilitated successful SP adoption and implementation, but required specific individual, relational, organisational, and institutional resources and conditions. Feldman, M.S., 2000. Organizational Routines as a Source of Continuous Change. Organ. Sci. 11, 611-629.
Quality use of publicly subsidised tapentadol in Australia: a population‐based analysis
AbstractBackgroundSustained‐release (SR) tapentadol was listed on Australia's Pharmaceutical Benefits Scheme (PBS) in 2014 for chronic severe pain requiring long‐term opioid treatment. Dispensings have increased since listing despite declining trends in other PBS‐listed opioids. Preferential prescribing of SR opioids may increase the risk of dependence and accidental overdose, particularly when used to treat acute pain.AimsTo explore the quality use of publicly subsidised tapentadol in Australia.MethodsWe examined annual initiation rates and patterns of use of tapentadol (SR) in the dispensing records of a 10% random sample of PBS‐eligible Australians (2014–2021). We used national tapentadol sales data to assess the proportion of sales attributable to the PBS.ResultsTapentadol initiation increased from 2014, peaking at 7.5/1000 adult population in 2019 before declining to 5.3/1000 in 2021. We identified 63 766 new users between 2014 and 2020, of whom 92.8% discontinued in the first year following initiation, 58.0% had only a single dispensing and 34.3% had no other opioids dispensed in the 3 months before or after initiation. 27.8% of new users were dispensed tapentadol on the same day as potentially interacting medicines. There was a sustained drop in the proportion of sales attributable to the PBS from June 2020 onwards, from an average of 69.1%, to 63.9% of pack sales.ConclusionsPatterns of use suggest tapentadol (SR) is generally used for short duration. Although most tapentadol sold in Australia is subsidised, there is evidence of a shift towards private sales.
CHARIOT: a phase I study of berzosertib with chemoradiotherapy in oesophageal and other solid cancers using time to event continual reassessment method
Background: Berzosertib (M6620) is a highly potent (IC50 = 19 nM) and selective, first-in-class ataxia telangiectasia-mutated and Rad3-related protein kinase (ATR) inhibitor. This trial assessed the safety, preliminary efficacy, and tolerance of berzosertib in oesophageal cancer (A1 cohort) with RT and advanced solid tumours (A2 cohort) with cisplatin and capecitabine. Methods: Single-arm, open-label dose-escalation (Time-to-Event Continual Reassessment Method) trial with 16 patients in A1 and 18 in A2. A1 tested six dose levels of berzosertib with RT (35 Gy over 15 fractions in 3 weeks). Results: No dose-limiting toxicities (DLTs) in A1. Eight grade 3 treatment-related AEs occurred in five patients, with rash being the most common. The highest dose (240 mg/m2) was determined as the recommended phase II dose (RP2D) for A1. Seven DLTs in two patients in A2. The RP2D of berzosertib was 140 mg/m2 once weekly. The most common grade ≥3 treatment-related AEs were neutropenia and thrombocytopenia. No treatment-related deaths were reported. Conclusions: Berzosertib combined with RT is feasible and well tolerated in oesophageal cancer patients at high palliative doses. Berzosertib with cisplatin and capecitabine was well tolerated in advanced cancer. Further investigation is warranted in a phase 2 setting. Clinical trials identifier: EU Clinical Trials Register (EudraCT) - 2015-003965-27 ClinicalTrials.gov - NCT03641547.
Cost-utility analysis of molnupiravir plus usual care versus usual care alone as early treatment for community-based adults with COVID-19 and increased risk of adverse outcomes in the UK PANORAMIC trial.
BACKGROUND: The cost-effectiveness of molnupiravir, an oral antiviral for early treatment of SARS-CoV-2, has not been established in vaccinated populations. AIM: To evaluate the cost-effectiveness of molnupiravir relative to usual care alone among mainly vaccinated community-based people at higher risk of severe outcomes from COVID-19 over six months. DESIGN AND SETTING: Economic evaluation of the PANORAMIC trial in the UK. METHOD: A cost-utility analysis that adopted a UK National Health Service and personal social services perspective and a six-month time horizon was performed using PANORAMIC trial data. Cost-effectiveness was expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. Sensitivity and subgroup analyses assessed the impacts of uncertainty and heterogeneity. Threshold analysis explored the price for molnupiravir consistent with likely reimbursement. RESULTS: In the base case analysis, molnupiravir had higher mean costs of £449 (95% confidence interval [CI] 445 to 453) and higher mean QALYs of 0.0055 (95% CI 0.004 to 0.007) than usual care (mean incremental cost per QALY of £81190). Sensitivity and subgroup analyses showed similar results, except those aged ≥75 years with a 55% probability of being cost-effective at a £30000 per QALY threshold. Molnupiravir would have to be priced around £147 per course to be cost-effective at a £15000 per QALY threshold. CONCLUSION: Molnupiravir at the current cost of £513 per course is unlikely to be cost-effective relative to usual care over a six-month time horizon among mainly vaccinated COVID-19 patients at increased risk of adverse outcomes, except those aged ≥75 years.
Community initiatives for well-being in the United Kingdom and their role in developing social capital and addressing loneliness: A scoping review
Introduction: Loneliness can have a negative impact on people's physical and psychological well-being; building social capital is a potential means of addressing this connection. Community initiatives (e.g. groups, clubs, neighbourhood activities) may be a route that enables people to build social capital to tackle loneliness. Understanding what is known, and where gaps in knowledge exist, is important for advancing research on this topic. Methods: A scoping review was undertaken to explore the question – What community initiatives, with a focus on well-being, have been evaluated in the United Kingdom that include information about social capital and loneliness? Four databases (Medline, CINAHL, ASSIA and Embase) were searched for relevant research papers. References were screened by two researchers to identify if they met the review's inclusion criteria. Data were summarised as a narrative and in tables. Results: Five papers met the review's inclusion criteria. They all used qualitative methods. Findings suggested that social capital could be developed through creating a sense of trust, group cohesion and reciprocity among participants in the community initiatives. This connection enabled people to experience a sense of belonging and to feel they had a meaningful relationship with others, which appeared to alleviate feelings of loneliness. Conclusion: More research is warranted on the review topic, including studies that have employed quantitative or mixed methods. Clarity around definitions of social capital and loneliness in future research is required. Engagement with community initiatives can provide a formalised route to help people develop connections and counteract limitations in their social networks. However, individuals may be wary about attending community initiatives, needing support and encouragement to do so. Social prescribing link workers are one means of motivating people to access groups, events or organisations that could improve their well-being.
Supporting people with type 2 diabetes in effective use of their medicine through mobile health technology integrated with clinical care (SuMMiT-D pilot): results of a feasibility randomised trial
Background: The purpose of this 6-month intervention pilot feasibility randomised trial was to test sending brief messages using mobile phones to promote self-management through taking medication as prescribed to people with type 2 diabetes. This was to inform the design and conduct of a future large-scale United Kingdom-based clinical trial and establish the feasibility of recruitment, the technology used, follow-up, and data collection. Methods: A multicentre individually randomised, controlled parallel group trial in primary care, recruiting adults (≥ 35 years) with type 2 diabetes in England. Consenting participants were randomly allocated to receive short message system text messages up to four times a week, or usual care, for a period of 6 months; messages contained behavioural change techniques targeting medication use. The primary outcome was the rate of recruitment to randomisation of participants to the trial with a planned rate of 22 participants randomised per month. The study also aimed to establish the feasibility of follow-up at 6 months, with an aim of retaining more than 80% of participants. Data, including patient-reported measures, were collected at baseline and the end of the 6-month follow-up period, and a notes review was completed at 24 months. Results: The trial took place between 26 November 2018 and 30 September 2019. In total 209 participants were randomly allocated to intervention (n = 103) or usual care (n = 106). The maximum rate of monthly recruitment to the trial was 60–80 participants per month. In total, 12,734 messages were sent to participants. Of these messages, 47 were identified as having failed to be sent by the service provider. Participants sent 2,864 messages to the automated messaging system. Baseline data from medical records were available for > 90% of participants with the exception of cholesterol (78.9%). At 6 months, a further HbA1c measurement was reported for 67% of participants. In total medical record data were available at 6 months for 207 (99.0%) of participants and completed self-report data were available for 177 (84.7%) of participants. Conclusion: The feasibility of a large-scale randomised evaluation of brief message intervention for people with type 2 diabetes appears to be high using this efficient design. Failure rate of sending messages is low, rapid recruitment was achieved among people with type 2 diabetes, clinical data is available on participants from routine medical records and self-report of economic measures was acceptable. Trial registration: ISCTRN ISRCTN13404264. Registered on 10 October 2018.
Understanding and Improving Older People’s Well-Being through Social Prescribing Involving the Cultural Sector: Interviews from a Realist Evaluation
Social prescribing is a non-clinical approach to addressing social, environmental, and economic factors affecting how people feel physical and/or emotionally. It involves connecting people to “community assets” (e.g., local groups, organizations, and charities) that can contribute to positive well-being. We sought to explain in what ways, for whom, and why the cultural sector can support social prescribing with older people. We conducted semi-structured interviews with 28 older people (aged 60+) and 25 cultural sector staff. The following nine concepts, developed from interview data, progressed the understanding of tailoring cultural offers, which came from our previous realist review—immersion, buddying, café culture, capacity, emotional involvement, perseverance, autonomy, elitism, and virtual cultural offers. Through tailoring, we propose that older people might experience one or more of the following benefits from engaging with a cultural offer as part of social prescribing—being immersed, psychological holding, connecting, and transforming through self-growth.
Responses to real-world and hypothetical menthol flavor bans among US young adults who smoke menthol cigarettes.
IntroductionMenthol cigarette bans have been implemented in some US states and localities, and a federal ban is being proposed by the FDA. This study asks how young adults who use menthol cigarettes respond to changes in menthol cigarette availability.MethodsAn online survey of young adults ages 18-34 who reported smoking menthol cigarettes on ≥7 of 30 days around Thanksgiving 2019 (n=734), oversampling Massachusetts-the first state with a menthol ban. Participants reported their tobacco use behavior following real-world menthol cigarette bans or predicted their behavior under a hypothetical federal ban.ResultsMost respondents who exclusively smoked vs. dual used with e-cigarettes continued smoking/using combustible tobacco following real-world bans (95.3% vs. 86.9%), accessing menthol cigarettes from other jurisdictions. Fewer who smoked exclusively responded by using e-cigarettes compared to those who dual used (3.9% vs. 43.7%). Quitting all tobacco use (i.e. no smoking, vaping, or any tobacco use) was uncommon for both groups (3.6% vs. 9.0%). Under a hypothetical ban, majorities of those who exclusively smoke and who dual use predicted they would continue smoking (72.2% vs. 71.8%); fewer who smoke exclusively would use e-cigarettes compared to those who dual use (14.7% vs. 41.4%). Those who smoke exclusively were more likely to report quitting all tobacco compared to those who dual use (29.6% vs. 12.4%).ConclusionsUnder real-world and hypothetical menthol cigarette bans, most respondents continued smoking. However more young adults continued smoking following real-world bans, reflecting the limitations of local/state restrictions when menthol cigarettes are available in other jurisdictions.ImplicationsThis survey asked young adults who use menthol cigarettes how they responded to real-world changes in the availability of menthol cigarettes; 89% reported continuing to smoke. Those who smoked exclusively were far less likely to respond by switching to e-cigarettes compared to people who dual used both products. Under a hypothetical federal menthol cigarette ban, 72% of young adults predicted that they would continue smoking. Quitting all tobacco was less common in the real-world scenario compared to the hypothetical ban. Access to menthol cigarettes in other jurisdictions and flavored cigars likely dampen the public health benefit of menthol cigarette bans.