The primary objective of the Multi-, Inter-, and Cross-cultural Clinical Child Study (MIXCS) is to evaluate the hypothesis that the effects of cultural-adapted cognitive behavioural therapy (CA-CBT) and programme-adopted cognitive behavioural therapy (PA-CBT) for children and adolescents’ anxiety are both superior to a psychological control (moral education control: MEC) for reducing child and adolescent anxiety disorders and symptoms as well as related constructs. The secondary objective is to explore commonalities and differences in therapy factors between CA-CBT and PA-CBT.

The study has been designed as a randomised, controlled and assessor masked multicentre superiority trial with three groups: CA-CBT, PA-CBT and MEC. Primary outcome is remission of primary anxiety disorders evaluated by independent evaluators. Secondary outcomes are clinician’s severity ratings, child self-reported anxiety symptoms, depressive symptoms, cognitive errors and family accommodation, as well as parent-reported anxiety symptoms, and family accommodation. Competence and adherence of treatment, therapy factors in treatment sessions are also measured based on behavioural observation. Finally, satisfaction and comprehension are collected. We aim to recruit at least 99 families for the analysis. Treatment will be delivered weekly for 10 sessions and assessment will be conducted 2 weeks before the treatment (pre), 3 months after the base date when the treatment starts (post), 6 months (six months follow-up) and 12 months (12 months follow-up) after the postassessment.

The MIXCS study was approved by Doshisha University Research Ethics Review Committee, Kwansei Gakuin University Institutional Review Board for Medical and Biological Research Involving Human Subjects and Shinshu University Certified Review Board of Clinical Research. Regardless of the results, the primary outcome will be published in a journal, and if the efficacy and effectiveness of CA-CBT and/or PA-CBT are empirically supported, the authors will encourage dissemination of the programmes including the assessment system through key stakeholders in education, health, and welfare areas.

UMIN000038128

Transgender women experience disparities in sport participation that are exacerbated by policies from sport organisations and legislation in the USA regulating the participation of transgender women in the category that best aligns with their gender identity. Both transgender and cisgender women are affected by these policies because sport organisations do not have a clear understanding of the effects of gender-affirming hormone therapy on transgender women and the unfair advantage they may have over cisgender women athletes. This article describes a review protocol to understand disparities in sport participation of transgender women.

A systematic and scoping review is being conducted. Studies are included if they explore disparities in sport participation (ie, participation rates, real and/or perceived barriers to participation) of transgender women of any age. A search strategy has been developed for PubMed, EMBASE, Web of Science, Cochrane Library and CINAHL. Relevant grey literature will also be scanned. The planned search dates are July and August 2023.

This review does not directly involve human subjects, so ethical approval is not required. Findings from the systematic review will be disseminated via publications in peer-reviewed journals and conferences.

Although SARS-CoV-2 vaccines were first approved under Emergency Use Authorization by the Food and Drug Administration in late 2020 for adults, authorisation for young children 6 months to 6 months and adults aged

CASCADIA is a 4-year community-based prospective study of SARS-CoV-2 VE among 3500 adults and paediatric populations aged 6 months to 49 years in Oregon and Washington, USA. At enrolment and regular intervals, participants complete a sociodemographic questionnaire. Individuals provide a blood sample at enrolment and annually thereafter, with optional blood draws every 6 months and after infection and vaccination. Participants complete weekly self-collection of anterior nasal swabs and symptom questionnaires. Swabs are tested for SARS-CoV-2 and other respiratory pathogens by reverse transcription-PCR, with results of selected pathogens returned to participants; nasal swabs with SARS-CoV-2 detected will undergo whole genome sequencing. Participants who test positive for SARS-CoV-2 undergo serial swab collection every 3 days for 21 days. Serum samples are tested for SARS-CoV-2 antibody by binding and neutralisation assays.

The primary outcome is SARS-CoV-2 infection. Cox regression models will be used to estimate the incidence rate ratio associated with SARS-CoV-2 vaccination among the paediatric and adult population, controlling for demographic factors and other potential confounders.

All study materials including the protocol, consent forms, data collection instruments, participant communication and recruitment materials, were approved by the Kaiser Permanente Interregional Institutional Review Board, the IRB of record for the study. Results will be disseminated through peer-reviewed publications, presentations, participant newsletters and appropriate general news media.

Selecting effective implementation strategies to support guideline-concordant dental care is a complex process. For this research project, an online deliberative forum brought together staff from dental clinics to discuss the strengths and weaknesses of implementation strategies and barriers to implementation of a component of a dental (pit-and-fissure) guideline. The goal was to determine whether deliberative engagement enabled participants’ sharing of promotive and prohibitive voice about implementation strategies to promote guideline-concordant care.

Qualitative analysis of online chat transcripts of facilitated deliberations from 31 small group sessions.

Kaiser Permanente Dental (KP Dental) in the USA.

All staff from 16 dental offices.

The directed content analysis revealed that participants shared prohibitive and promotive voice when offering critique of the barriers and the implementation strategies suggested by the researchers. The analysis also revealed that the focus of the deliberations often was not on the aspect of the pit-and-fissure guideline intended by the research team for deliberation.

The deliberative forum discussions were a productive venue to ask staff in dental clinics to share their perspectives on strategies to promote guideline-concordant care as well as barriers. Participants demonstrated prohibitive voice and engaged critically with the materials the research team had put together. An important limitation of the deliberation was that the discussion often centred around an aspect of the pit-and-fissure guideline that already was implemented well. To ensure a deliberation oriented towards resolving challenging aspects of the pit-and-fissure guideline, greater familiarity with the guideline would have been important, as well as more intimate knowledge of the current discrepancies in guideline-concordant care.

This project is registered at ClinicalTrials.gov with ID NCT04682730. The trial was first registered on 18 December 2020. https://clinicaltrials.gov/ct2/show/NCT04682730.

The Australian population presenting with surgical pathology is becoming older, frailer and more comorbid. Shared decision-making is rapidly becoming the gold standard of care for patients considering high-risk surgery to ensure that appropriate, value-based healthcare decisions are made. Positive benefits around patient perception of decision-making in the immediacy of the decision are described in the literature. However, short-term and long-term holistic patient-centred outcomes and cost implications for the health service require further examination to better understand the full impact of shared decision-making in this population.

We propose a novel multidisciplinary shared decision-making model of care in the perioperative period for patients considering high-risk surgery in the fields of general, vascular and head and neck surgery. We assess it in a two arm prospective randomised controlled trial. Patients are randomised to either ‘standard’ perioperative care, or to a multidisciplinary (surgeon, anaesthetist and end-of-life care nurse practitioner or social worker) shared decision-making consultation. The primary outcome is decisional conflict prior to any surgical procedure occurring. Secondary outcomes include the patient’s treatment choice, how decisional conflict changes longitudinally over the subsequent year, patient-centred outcomes including life impact and quality of life metrics, as well as morbidity and mortality. Additionally, we will report on healthcare resource use including subsequent admissions or representations to a healthcare facility up to 1 year.

This study has been approved by the Hunter New England Human Research Ethics Committee (2019/ETH13349). Study findings will be presented at local and national conferences and within scientific research journals.

ACTRN12619001543178.

The implications of family presence during critical illness on clinical and psychosocial outcomes remain of great social, scientific and operational interest. Existing experimental and observational evidence demonstrates that policies supporting family presence decrease the prevalence and duration of delirium among patients with critical illness.1 Delirium is a fluctuating change in consciousness that occurs frequently among critically ill patients and is associated with poor outcomes. This study...

To (1) understand what behaviours, beliefs, demographics and structural factors predict US adults’ intention to get a COVID-19 vaccination, (2) identify segments of the population (‘personas’) who share similar factors predicting vaccination intention, (3) create a ‘typing tool’ to predict which persona people belong to and (4) track changes in the distribution of personas over time and across the USA.

Three surveys: two on a probability-based household panel (NORC’s AmeriSpeak) and one on Facebook.

The first two surveys were conducted in January 2021 and March 2021 when the COVID-19 vaccine had just been made available in the USA. The Facebook survey ran from May 2021 to February 2022.

All participants were aged 18+ and living in the USA.

In our predictive model, the outcome variable was self-reported vaccination intention (0–10 scale). In our typing tool model, the outcome variable was the five personas identified by our clustering algorithm.

Only 1% of variation in vaccination intention was explained by demographics, with about 70% explained by psychobehavioural factors. We identified five personas with distinct psychobehavioural profiles: COVID Sceptics (believe at least two COVID-19 conspiracy theories), System Distrusters (believe people of their race/ethnicity do not receive fair healthcare treatment), Cost Anxious (concerns about time and finances), Watchful (prefer to wait and see) and Enthusiasts (want to get vaccinated as soon as possible). The distribution of personas varies at the state level. Over time, we saw an increase in the proportion of personas who are less willing to get vaccinated.

Psychobehavioural segmentation allows us to identify why people are unvaccinated, not just who is unvaccinated. It can help practitioners tailor the right intervention to the right person at the right time to optimally influence behaviour.

There has been considerable debate about whether plant milks can support the nutritional requirements of growing children. The proposed systematic review aims to assess the evidence on the relationship between plant milk consumption and growth and nutritional status in childhood.

Ovid MEDLINE ALL (1946–present), Ovid EMBASE Classic (1947–present), CINAHL Complete (Cumulative Index to Nursing and Allied Health Literature), Scopus, the Cochrane Library and grey literature will be searched comprehensively (from 2000 to present; English language) to find studies that describe the association between plant milk consumption and growth or nutrition in children 1–18 years of age. Two reviewers will identify eligible articles, extract data and assess the risk of bias in individual studies. If a meta-analyses is not conducted, the evidence will be synthesised narratively and the overall certainty of evidence will be rated using the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethical approval is not required for this study since no data will be collected. Results of the systematic review will be published in a peer-reviewed journal. Findings from this study may be useful in informing future evidence-based recommendations about plant milk consumption in children.

CRD42022367269.

The National Clinical Excellence Awards (NCEAs) in England and Wales were designed, as a form of performance-related pay, to reward high-performing senior doctors and dentists. To inform future scoring of applications and subsequent schemes, we sought to understand how current assessors and other stakeholders would define excellence, differentiate between levels of excellence and ensure unbiased definitions and scoring.

Semistructured qualitative interview study.

25 key informants were identified from Advisory Committee on Clinical Excellence Awards subcommittees, and relevant professional organisations in England and Wales. Informants were purposively sampled to achieve variety in gender and ethnicity.

Participants reported that NCEAs had a role in incentivising doctors to strive for excellence. They were consistent in identifying ‘clinical excellence’ as involving making an exceptional difference to patients and the National Health Service, and in going over and above the expectations associated with the doctor’s job plan. Informants who were assessors reported: encountering challenges with the current scoring scheme when seeking to ensure a fair assessment; recognising tendencies to score more or less leniently; and the potential for conscious or unconscious bias in assessments. Particular groups of doctors, including women, doctors in some specialties and settings, doctors from minority ethnic groups, and doctors who work less than full time, were described as being less likely to self-nominate, lacking support in making applications or lacking motivation to apply on account of a perceived likelihood of not being successful. Practical suggestions were made for improving support and training for applicants and assessors.

Participants in this qualitative study identified specific concerns in respect of the current approaches adopted in applying for and in assessing NCEAs, pointing to the importance of equity of opportunity to apply, the need for regular training for assessors, and to improved support for applicants and potential applicants.

Electronic nicotine delivery systems (ENDS) products have emerged as the most popular alternative to combustible cigarettes. However, ENDS products contain potentially dangerous toxicants and chemical compounds, and little is known about their health effects. The aim of the present study was to examine the prospective association between cigarette and ENDS use on self-reported incident hypertension.

Longitudinal cohort study.

Nationally representative sample of the civilian, non-institutionalised population in the USA.

17 539 adults aged 18 or older who participated at follow-up and had no self-reported heart condition or previous diagnosis of hypertension or high cholesterol at baseline.

We constructed a time-varying tobacco exposure, lagged by one wave, defined as no use, exclusive established use (every day or some days) of ENDS or cigarettes, and dual use. We controlled for demographics (age, sex, race/ethnicity and household income), clinical risk factors (family history of heart attack, obesity, diabetes and binge drinking) and smoking history (cigarette pack-years).

Self-reported incident hypertension diagnosis.

The self-reported incidence of hypertension was 3.7% between wave 2 and wave 5. At baseline, 18.0% (n=5570) of respondents exclusively smoked cigarettes; 1.1% (n=336) exclusively used ENDS; and 1.7% (n=570) were dual users. In adjusted models, exclusive cigarette use was associated with an increased risk of self-reported incident hypertension compared with non-use (adjusted HR (aHR) 1.21, 95% CI 1.06 to 1.38), while exclusive ENDS use (aHR 1.00, 95% CI 0.68 to 1.47) and dual use (aHR 1.15, 95% CI 0.87 to 1.52) were not.

We found that smoking increased the risk of self-reported hypertension, but ENDS use did not. These results highlight the importance of using prospective longitudinal data to examine the health effects of ENDS use.

Ceramides have been associated with several ageing-related conditions but have not been studied as a general biomarker of multimorbidity (MM). Therefore, we determined whether ceramide levels are associated with the rapid development of MM.

Retrospective cohort study.

Mayo Clinic Biobank.

1809 persons in the Mayo Clinic Biobank ≥65 years without MM at the time of enrolment, and with ceramide levels assayed from stored plasma.

Persons were followed for a median of 5.7 years through their medical records to identify new diagnoses of 20 chronic conditions. The number of new conditions was divided by the person-years of follow-up to calculate the rate of accumulation of new chronic conditions.

Higher levels of C18:0 and C20:0 were associated with a more rapid rate of accumulation of chronic conditions (C18:0 z score RR: 1.30, 95% CI: 1.10 to 1.53; C20:0 z score RR: 1.26, 95% CI: 1.07 to 1.49). Higher C18:0 and C20:0 levels were also associated with an increased risk of hypertension and coronary artery disease.

C18:0 and C20:0 were associated with an increased risk of cardiometabolic conditions. When combined with biomarkers specific to other diseases of ageing, these ceramides may be a useful component of a biomarker panel for predicting accelerated ageing.

Although elective surgery is generally safe, some procedures remain associated with an increased risk of complications. Improved preoperative risk stratification and earlier recognition of these complications may ameliorate postoperative recovery and improve long-term outcomes. The perioperative longitudinal study of complications and long-term outcomes (PLUTO) cohort aims to establish a comprehensive biorepository that will facilitate research in this field. In this profile paper, we will discuss its design rationale and opportunities for future studies.

Patients undergoing elective intermediate to high-risk non-cardiac surgery are eligible for enrolment. For the first seven postoperative days, participants are subjected to daily bedside visits by dedicated observers, who adjudicate clinical events and perform non-invasive physiological measurements (including handheld spirometry and single-channel electroencephalography). Blood samples and microbiome specimens are collected at preselected time points. Primary study outcomes are the postoperative occurrence of nosocomial infections, major adverse cardiac events, pulmonary complications, acute kidney injury and delirium/acute encephalopathy. Secondary outcomes include mortality and quality of life, as well as the long-term occurrence of psychopathology, cognitive dysfunction and chronic pain.

Enrolment of the first participant occurred early 2020. During the inception phase of the project (first 2 years), 431 patients were eligible of whom 297 patients consented to participate (69%). Observed event rate was 42% overall, with the most frequent complication being infection.

The main purpose of the PLUTO biorepository is to provide a framework for research in the field of perioperative medicine and anaesthesiology, by storing high-quality clinical data and biomaterials for future studies. In addition, PLUTO aims to establish a logistical platform for conducting embedded clinical trials.

NCT05331118.

Acute kidney injury (AKI) is a common complication after cardiac surgery (CS) and is associated with adverse short-term and long-term outcomes. Alpha-1-microglobulin (A1M) is a circulating glycoprotein with antioxidant, heme binding and mitochondrial-protective mechanisms. RMC-035 is a modified, more soluble, variant of A1M and has been proposed as a novel targeted therapeutic protein to prevent CS-associated AKI (CS-AKI). RMC-035 was considered safe and generally well tolerated when evaluated in four clinical phase 1 studies.

This is a phase 2, randomised, double-blind, adaptive design, parallel group clinical study that evaluates RMC-035 compared with placebo in approximately 268 cardiac surgical patients at high risk for CS-AKI. RMC-035 is administered as an intravenous infusion. In total, five doses will be given. Dosing is based on presurgery estimated glomerular filtration rate (eGFR), and will be either 1.3 or 0.65 mg/kg.

The primary study objective is to evaluate whether RMC-035 reduces the incidence of postoperative AKI, and key secondary objectives are to evaluate whether RMC-035 improves postoperative renal function compared with placebo. A blinded interim analysis with potential sample size reassessment is planned once 134 randomised subjects have completed dosing. An independent data monitoring committee will evaluate safety and efficacy data at prespecified intervals throughout the trial. The study is a global multicentre study at approximately 30 sites.

The trial was approved by the joint ethics committee of the physician chamber Westfalen-Lippe and the University of Münster (code ‘2021-778 f-A’) and subsequently approved by the responsible ethics committees/relevant institutional review boards for the participating sites. The study is conducted in accordance with Good Clinical Practice, the Declaration of Helsinki and other applicable regulations. Results of this study will be published in a peer-reviewed scientific journal.

NCT05126303.

Geriatric guidelines strongly recommend avoiding benzodiazepines and non-benzodiazepine sedative hypnotics in older adults. Hospitalisation may provide an important opportunity to begin the process of deprescribing these medications, particularly as new contraindications arise. We used implementation science models and qualitative interviews to describe barriers and facilitators to deprescribing benzodiazepines and non-benzodiazepine sedative hypnotics in the hospital and develop potential interventions to address identified barriers.

We used two implementation science models, the Capability, Opportunity and Behaviour Model (COM-B) and the Theoretical Domains Framework, to code interviews with hospital staff, and an implementation process, the Behaviour Change Wheel (BCW), to codevelop potential interventions with stakeholders from each clinician group.

Interviews took place in a tertiary, 886-bed hospital located in Los Angeles, California.

Interview participants included physicians, pharmacists, pharmacist technicians, and nurses.

We interviewed 14 clinicians. We found barriers and facilitators across all COM-B model domains. Barriers included lack of knowledge about how to engage in complex conversations about deprescribing (capability), competing tasks in the inpatient setting (opportunity), high levels of resistance/anxiety among patients to deprescribe (motivation), concerns about lack of postdischarge follow-up (motivation). Facilitators included high levels of knowledge about the risks of these medications (capability), regular rounds and huddles to identify inappropriate medications (opportunity) and beliefs that patients may be more receptive to deprescribing if the medication is related to the reason for hospitalisation (motivation). Potential modes of delivery included a seminar aimed at addressing capability and motivation barriers in nurses, a pharmacist-led deprescribing initiative using risk stratification to identify and target patients at highest need for deprescribing, and the use of evidence-based deprescribing education materials provided to patients at discharge.

While we identified numerous barriers and facilitators to initiating deprescribing conversations in the hospital, nurse- and pharmacist-led interventions may be an appropriate opportunity to initiate deprescribing.

Ear pain is the most prominent symptom of childhood acute otitis media (AOM). To control the pain and reduce reliance on antibiotics, evidence of effectiveness for alternative interventions is urgently needed. This trial aims to investigate whether analgesic ear drops added to usual care provide superior ear pain relief over usual care alone in children presenting to primary care with AOM.

This is a pragmatic, two-arm, individually randomised, open, superiority trial with cost-effectiveness analysis and nested mixed-methods process evaluation in general practices in the Netherlands. We aim to recruit 300 children aged 1–6 years with a general practitioner (GP) diagnosis of AOM and ear pain. Children will be randomly allocated (ratio 1:1) to either (1) lidocaine hydrochloride 5 mg/g ear drops (Otalgan) one to two drops up to six times daily for a maximum of 7 days in addition to usual care (oral analgesics, with/without antibiotics); or (2) usual care. Parents will complete a symptom diary for 4 weeks as well as generic and disease-specific quality of life questionnaires at baseline and 4 weeks. The primary outcome is the parent-reported ear pain score (0–10) over the first 3 days. Secondary outcomes include proportion of children consuming antibiotics, oral analgesic use and overall symptom burden in the first 7 days; number of days with ear pain, number of GP reconsultations and subsequent antibiotic prescribing, adverse events, complications of AOM and cost-effectiveness during 4-week follow-up; generic and disease-specific quality of life at 4 weeks; parents’ and GPs’ views and experiences with treatment acceptability, usability and satisfaction.

The Medical Research Ethics Committee Utrecht, the Netherlands, has approved the protocol (21-447/G-D). All parents/guardians of participants will provide written informed consent. Study results will be submitted for publication in peer-reviewed medical journals and presented at relevant (inter)national scientific meetings.

The Netherlands Trial Register: NL9500; date of registration: 28 May 2021. At the time of publication of the study protocol paper, we were unable to make any amendments to the trial registration record in the Netherlands Trial Register. The addition of a data sharing plan was required to adhere to the International Committee of Medical Journal Editors guidelines. The trial was therefore reregistered in ClinicalTrials.gov (NCT05651633; date of registration: 15 December 2022). This second registration is for modification purposes only and the Netherlands Trial Register record (NL9500) should be regarded as the primary trial registration.

Many patients experience unrelieved neuropathic cancer-related pain. Most current analgesic therapies have psychoactive side effects, lack efficacy data for this indication and have potential medication-related harms. The local anaesthetic lidocaine (lignocaine) has the potential to help manage neuropathic cancer-related pain when administered as an extended, continuous subcutaneous infusion. Data support lidocaine as a promising, safe agent in this setting, warranting further evaluation in robust, randomised controlled trials. This protocol describes the design of a pilot study to evaluate this intervention and explains the pharmacokinetic, efficacy and adverse effects evidence informing the design.

A mixed-methods pilot study will determine the feasibility of an international first, definitive phase III trial to evaluate the efficacy and safety of an extended continuous subcutaneous infusion of lidocaine for neuropathic cancer-related pain. This study will comprise: a phase II double-blind randomised controlled parallel-group pilot of subcutaneous infusion of lidocaine hydrochloride 10% w/v (3000 mg/30 mL) or placebo (sodium chloride 0.9%) over 72 hours for neuropathic cancer-related pain, a pharmacokinetic substudy and a qualitative substudy of patients’ and carers’ experiences. The pilot study will provide important safety data and help inform the methodology of a definitive trial, including testing proposed recruitment strategy, randomisation, outcome measures and patients’ acceptability of the methodology, as well as providing a signal of whether this area should be further investigated.

Participant safety is paramount and standardised assessments for adverse effects are built into the trial protocol. Findings will be published in a peer-reviewed journal and presented at conferences. This study will be considered suitable to progress to a phase III study if there is a completion rate where the CI includes 80% and excludes 60%. The protocol and Patient Information and Consent Form have been approved by Sydney Local Health District (Concord) Human Research Ethics Committee 2019/ETH07984 and University of Technology Sydney ETH17-1820.

ANZCTR ACTRN12617000747325.

Synthesising evidence of the effects of interventions to improve work participation among people with health problems is currently difficult due to heterogeneity in outcome measurements. A core outcome set for work participation is needed.

Following the Core Outcome Measures in Effectiveness Trials methodology, we used a five-step approach to reach international multistakeholder consensus on a core outcome set for work participation. Five subgroups of stakeholders took part in two rounds of discussions and completed two Delphi voting rounds on 26 outcomes. A consensus of ≥80% determined core outcomes and 50%–80% consensus was required for candidate outcomes.

Fifty-eight stakeholders took part in the Delphi rounds. Core outcomes were: ‘any type of employment including self-employment’, ‘proportion of workers that return to work after being absent because of illness’ and ‘time to return to work’. Ten candidate outcomes were proposed, among others: ‘sustainable employment’, ‘work productivity’ and ‘workers’ perception of return to work’.

As a minimum, all studies evaluating the impact of interventions on work participation should include one employment outcome and two return to work outcomes if workers are on sick leave prior to the intervention.

To examine health behaviours of refugees and asylum seekers, in relation to their knowledge of public benefits and legal rights.

Qualitative study, utilising an open-ended, semi-structured interview guide to ensure information-rich data collection. Thematic content was analysed using qualitative research software.

Participants were drawn from the Weill Cornell Center for Human Rights (WCCHR) in New York City, a single-center, human rights clinic with a globally representative patient population. All interviews were conducted at the Weill Cornell Medicine Clinical and Translational Science Center, a multidisciplinary space within an urban academic medical center.

Twenty-four refugees and asylum seekers currently living in the greater New York City area. Eligible participants were 18 years of age or older and had previously sought services from the WCCHR. The recruitment rate was 55%.

Themes and concepts in participants’ health, knowledge, perceptions of and experiences with accessing healthcare and public benefits programmes.

Twenty-four participants represented 18 countries of origin and 11 primary languages. Several impediments to accessing healthcare and public benefits were identified, including pragmatic barriers (such as prohibitive costs or lack of insurance), knowledge gaps and mistrust of healthcare systems.

There is low health engagement by refugees and asylum seekers, as a result of multiple, complex factors impeding the ability of refugee and asylum seekers to access healthcare and other public benefits for which they are eligible—with resultant detrimental health effects. However, there is an opportunity to utilise novel approaches, such as digital technologies, to communicate relevant information regarding legal rights and public benefits to advance the health of vulnerable individuals such as refugees and asylum seekers.

To synthesise the qualitative evidence of embodied experiences of people who have survived a stroke, the experiences of making sense of oneself, others and the world in the poststroke bodies.

Design

Qualitative systematic review.

Five electronic databases, PsycINFO, PubMed, MEDLINE, CINAHL Plus and Cochrane Library, were employed to search for qualitative studies published up to February 2022.

Literature in English that employed qualitative methods to investigate the embodied experiences of people who have survived a stroke.

Two reviewers independently appraised the quality of the included studies based on the tool developed by Salter et al in 2008. It consists of seven questions assessing the credibility and relevance of the studies. Discrepancies were resolved until a consensus was reached.

Thematic synthesis was applied to synthesise the related findings from all the included studies. Two reviewers were involved in the process.

1482 records were identified. After the screening process, 34 studies were included in this review. Three analytical themes and their related descriptive themes emerged. Analytical themes included ‘disconnection between oneself, others and the world,’ ‘the transitional period: exploring and negotiating,’ and ‘reconnecting with oneself, others and the world’.

The findings demonstrated that the embodied experiences of people who have survived a stroke progressed from feeling disconnected to reconnecting with themselves, others and the world. Stroke recovery should not only be limited to functional restoration. Approaching ‘re-embodiment’, the realignment between oneself and one’s body, is crucial in reintegrating with others and the world on the trajectory toward recovery.

CRD42020183125

Opioid prescribing rates are disproportionately high in the North of England. In addition to patients’ complex health needs, clinician prescribing behaviour is also a key driver. Although strategies have been initiated to reduce opioid prescribing nationally, the COVID-19 pandemic has interrupted service provision and created challenges for the system and health professionals to tackle this complex issue. A pilot intervention using smartphone video messaging has been developed to remotely explain the rationale for opioid reduction and facilitate self-initiation of support. The aim of this study is to evaluate the potential benefits, risks and economic consequences of ‘at scale’ implementation.

This will be a mixed-methods study comprising a quasi-experimental non-randomised before-and-after study and qualitative interviews. The intervention arm will comprise 50 General Practitioner (GP) Practices using System 1 (a clinical computer system hosting the intervention) who will deliver the video to their patients via text message. The control arm will comprise 50 practices using EMIS (a different computer system) who will continue usual care. Monthly practice level prescribing and consultation data will be observed for 6 months postintervention. A general linear model will be used to estimate the association between the exposure and the main outcome (opioid prescribing; average daily quantity (ADQ)/1000 specific therapeutic group age-sex related prescribing unit). Semi-structured interviews will be undertaken remotely with purposively selected participants including patients who received the video, and health professionals involved in sending out the videos and providing additional support. Interviews will be audio recorded, transcribed and analysed thematically.

Ethics approval has been granted by the NHS Health Research Authority Research Ethics Committee (22/PR/0296). Findings will be disseminated to the participating sites, participants, and commissioners, and in peer-reviewed journals and academic conferences.

NCT05276089.