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INTRODUCTION: Children who are deaf or hard-of-hearing (DHH) are at risk for speech and language delay. Language outcomes are worse in DHH children from lower socioeconomic backgrounds, due in part to disparities in access to specialised speech-language therapy. Teletherapy may help improve access to this specialised care and close this language gap. Inclusion of diverse DHH children in prospective randomised clinical trials has been challenging but is necessary to address disparities and pursue hearing health equity. Stakeholder input regarding decisions on study design elements, including comparator groups, masking, assessments and compensation, is necessary to design inclusive studies. We have designed an inclusive, equitable comparativeness effectiveness trial to address disparities in paediatric hearing health. The specific aims of the study are to determine the effect of access to and utilisation of speech-language teletherapy in addressing language disparities in low-income children who are DHH. METHODS AND ANALYSIS: After stakeholder input and pilot data collection, we designed a randomised clinical trial and concurrent longitudinal cohort trial to be conducted at four tertiary childrens hospitals in the USA. Participants will include 210 DHH children aged 0-27 months. 140 of these children will be from lower income households, who will be randomised 1:1 to receive usual care versus usual care plus access to supplemental speech-language teletherapy. 70 children from higher income households will be simultaneously recruited as a comparison cohort. Primary outcome measure will be the Preschool Language Scales Auditory Comprehension subscale standard score, with additional speech, language, hearing and quality of life validated measures as secondary outcomes. ETHICS AND DISSEMINATION: This study was approved by the Institutional Review Boards of the participating sites: the University of California, San Francisco (19-28356), Rady Childrens Hospital (804651) and Seattle Childrens Hospital (STUDY00003750). Parents of enrolled children will provide written informed consent for their childs participation. Professional and parent stakeholder groups that have been involved throughout the study design will facilitate dissemination and implementation of study findings via publication and through national and regional organisations. TRIAL REGISTRATION NUMBER: NCT04928209.

ObjectivesThis study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico.DesignWe conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention's effect on patients' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention's benefits and barriers and understand its feasibility.Participants50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers.SettingOncology services in three public hospitals of the Mexican Social Security Institute.InterventionThe ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks.Results50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms.ConclusionsThis pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation.Trial registration numberClinicalTrials.gov ID: NCT05925257.

INTRODUCTION: A greater extent of resection of the contrast-enhancing (CE) tumour part has been associated with improved outcomes in glioblastoma. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in high-grade glioma (HGG) patients in terms of survival, functional, neurological, cognitive and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively. METHODS AND ANALYSIS: This study is an international, multicentre, prospective, two-arm cohort study of observational nature. Consecutive glioblastoma patients will be operated with SMR or maximal resection at a 1:1 ratio. Primary endpoints are (1) overall survival and (2) proportion of patients with National Institute of Health Stroke Scale deterioration at 6 weeks, 3 months and 6 months postoperatively. Secondary endpoints are (1) residual CE and NCE tumour volume on postoperative T1-contrast and FLAIR (Fluid-attenuated inversion recovery) MRI scans; (2) progression-free survival; (3) receipt of adjuvant therapy with chemotherapy and radiotherapy; and (4) quality of life at 6 weeks, 3 months and 6 months postoperatively. The total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. ETHICS AND DISSEMINATION: The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.

INTRODUCTION: Depression occurs in over 50% of individuals living with multiple sclerosis (MS) and can be treated using many modalities. Yet, it remains: under-reported by patients, under-ascertained by clinicians and under-treated. To enhance these three behaviours likely to promote evidence-based depression care, we engaged multiple stakeholders to iteratively design a first-in-kind digital health tool. The tool, MS CATCH (Care technology to Ascertain, Treat, and engage the Community to Heal depression in patients with MS), closes the communication loop between patients and clinicians. Between clinical visits, the tool queries patients monthly about mood symptoms, supports patient self-management and alerts clinicians to worsening mood via their electronic health record in-basket. Clinicians can also access an MS CATCH dashboard displaying patients mood scores over the course of their disease, and providing comprehensive management tools (contributing factors, antidepressant pathway, resources in patients neighbourhood). The goal of the current trial is to evaluate the clinical effect and usability of MS CATCH in a real-world clinical setting. METHODS AND ANALYSIS: MS CATCH is a single-site, phase II randomised, delayed start, trial enrolling 125 adults with MS and mild to moderately severe depression. Arm 1 will receive MS CATCH for 12 months, and arm 2 will receive usual care for 6 months, then MS CATCH for 6 months. Clinicians will be randomised to avoid practice effects. The effectiveness analysis is superiority intent-to-treat comparing MS CATCH to usual care over 6 months (primary outcome: evidence of screening and treatment; secondary outcome: Hospital Anxiety Depression Scale-Depression scores). The usability of the intervention will also be evaluated (primary outcome: adoption; secondary outcomes: adherence, engagement, satisfaction). ETHICS AND DISSEMINATION: University of California, San Francisco Institutional Review Board (22-36620). The findings of the study are planned to be shared through conferences and publishments in a peer-reviewed journal. The deidentified dataset will be shared with qualified collaborators on request, provision of CITI and other certifications, and data sharing agreement. We will share the results, once the data are complete and analysed, with the scientific community and patient/clinician participants through abstracts, presentations and manuscripts. TRIAL REGISTRATION NUMBER: NCT05865405.

IntroductionNearly 30 000 Mexican women develop breast cancer annually, frequently presenting unmet supportive care needs. In high-income countries, incorporating electronic patient-reported outcomes (ePROs) into cancer care has demonstrated potential for increasing patient-centred care and reducing unmet needs. No such ePRO interventions have been implemented in Mexico. This paper presents the study protocol for designing and evaluating an ePRO digital health application combined with proactive follow-up by nurses.Methods and analysisWe designed a two-component intervention for women receiving breast cancer treatment: a responsive web application for monitoring ePROs and clinical algorithms guiding proactive follow-up by nurses. We will conduct a pilot test of the intervention with 50 patients with breast cancer for 6 weeks to assess feasibility and adjust the application. We will conduct a parallel arm randomised controlled trial assigning 205 patients each to intervention and control in one of Mexico's largest public oncology hospitals. The intervention will be provided for 6 months, with additional 3 months of post-intervention observation. The control group will receive usual healthcare and a list of breast cancer information sources. Women diagnosed with stages I, II or III breast cancer who initiate chemotherapy and/or radiotherapy will be invited to participate. The primary study outcome will be supportive care needs; secondary outcomes include global quality of life and breast symptoms. Information on the outcomes will be obtained through web-based self-administered questionnaires collected at baseline, 1, 3, 6 and 9 months.Ethics and disseminationThe National Research and Ethics Committees of the Mexican Institute of Social Security approved the study (R-2021-785-059). Participants will sign an informed consent form prior to their inclusion. Findings will be disseminated through a policy brief to the local authorities, a webinar for patients, publications in peer-reviewed journals and presentations at national and international conferences.Trial registration numberNCT05925257.

IntroductionPhysical activity (PA) promotes significant physical and psychosocial benefits for breast cancer survivors. While evidence exists regarding recommendations for the frequency, duration and intensity of exercise that optimise PA benefits for cancer survivors, the role of the environment in achieving optimal outcomes has yet to be determined. This paper presents a protocol for a clinical trial to evaluate the feasibility of a 3-month nature-based walking programme for breast cancer survivors. Secondary outcomes assessed include the impact of the intervention on fitness, quality of life outcomes, and biomarkers of ageing and inflammation.Methods and analysisThe trial is a 12-week single-arm pilot study. Twenty female breast cancer survivors will engage in a supervised moderate intensity walking intervention in small groups in a nature reserve for 50 minutes three times per week. Data will be collected at baseline and end of study, and include assessment of inflammatory cytokines and anti-inflammatory myokines (TNF-α, IL-1ß, IL-6, CRP, TGF-ß, IL-10, IL-13), as well as ageing (DNA methylation, ageing genes) biomarkers; surveys (Patient-Reported Outcomes Measurement Information System-29, Functional Assessment of Cancer Therapy-General, Post-Traumatic Growth Inventory); and fitness assessments (6 min Walk Test, Grip-Strength, One Repetition-Maximum Leg Press). Participants will also complete weekly surveys assessing social support and participate in an exit interview. This is an important first step for future research on the influence of exercise environment on cancer survivor PA outcomes.Ethics and disseminationThis study was approved by the Cedars Sinai Medical Center Institutional Review Board (IIT2020-20). Findings will be disseminated through academic manuscripts, conferences, and community presentations.Trial registration numberNCT04896580.

INTRODUCTION: There are unmet mental health needs of depressed adolescents and young adults (AYAs) across the USA. Behavioural technology adequately integrated into clinical care delivery has potential to improve care access and efficiency. This multisite randomised controlled trial evaluates how a coach-enhanced digital cognitive behavioural intervention (dCBI) enhances usual care for depressed AYAs in paediatric practices with minority enriched samples. METHODS AND ANALYSIS: Participants (n=750) ages 16-22 who meet threshold criteria for depressive severity (Patient Health Questionnaire-9; PHQ-9 score 10-24) will be recruited through paediatric practices across three academic institutions (Boston, Pittsburgh and San Diego). Participants will be randomised to 12 weeks of dCBI+treatment as usual (TAU) (n=450) or TAU alone (n=300) in outpatient paediatric practices. Assessments will be completed at baseline, 6 weeks and 12 weeks with the primary outcome being improvement in clinician-rated and self-reported depressive severity (Childrens Depression Rating Scale-Revised and PHQ-9) and secondary outcomes being self-reported suicidal ideation (item 9 on PHQ-9), anxiety severity (Generalised Anxiety Disorder), general quality of life (Satisfaction with Life Scale) and general functioning (Childrens Global Assessment Scale). The study design is an intent-to-treat mixed effects regression with group, and covariates nested within the sites. ETHICS AND DISSEMINATION: All participants or their parent/guardian (under 18 years or unemancipated) will give informed consent to a study team member. All data are expected to be collected over 18 months. The Institutional Review Board (IRB) is a board at each institution in the United States that reviews and monitors research involving human subjects. IRB approval from the University of Pittsburgh was obtained on 30 November 2021 (STUDY21080150), from the University of California San Diegos Human Research Protection Program IRB on 14 July 2022 (802047), and from the Boston Childrens Hospital IRB on 25 October 2022 (P00040987). Full study results are planned to be published within 2 years of initial study recruitment (October 2024). Dissemination of findings will occur in peer-reviewed journals, professional conferences and through reports to participating entities and stakeholders. TRIAL REGISTRATION NUMBER: NCT05159713; ClinicalTrials.gov.

IntroductionPain, comorbid fatigue and sleep disturbances are common and distressing symptoms for patients with advanced cancer, negatively impacting their quality of life. Clinical guidelines recommend non-pharmacological interventions, including acupuncture and massage, for pain management in adult patients with cancer in adjunct to conventional care. However, high-quality evidence about the comparative effectiveness and long-term durability of these therapies for symptom management is limited.Methods and analysisWe describe the design of a two-arm, parallel group, multicentre randomised controlled trial that investigates the use of acupuncture versus massage for musculoskeletal pain among 300 patients with diverse types of advanced cancer. The primary aim is to evaluate the long-term effectiveness (26 weeks from randomisation) of acupuncture vs massage for pain (primary outcome) and comorbid symptoms (fatigue, sleep disturbance and quality of life). The secondary aim is to identify patient-level demographic characteristics (eg, sex, race, age), clinical factors (eg, insomnia, pain severity) and psychological attributes that are associated with a greater reduction in pain for either acupuncture or massage. Patients will receive weekly acupuncture or massage treatments for 10 weeks, followed by monthly booster sessions up to 26 weeks. The primary endpoint will be the change in worst pain intensity score from baseline to 26 weeks. We will collect validated patient-reported outcomes at multiple time points over 26 weeks.Ethics and disseminationThe Institutional Review Board at Memorial Sloan Kettering Cancer Center in New York approved this protocol. Results will be disseminated via peer-reviewed scientific journals and conference presentations. Our findings will help patients and healthcare providers make informed decisions about incorporating non-pharmacological treatments to manage pain for patients with advanced cancer.Trial registration numberNCT04095234.

IntroductionPersonal digital devices that provide health information, such as the Apple Watch, have developed an increasing array of cardiopulmonary tracking features which have received regulatory clearance and are directly marketed to consumers. Despite their widespread and increasing use, data about the impact of personal digital device use on patient-reported outcomes and healthcare utilisation are sparse. Among a population of patients with atrial fibrillation and/or atrial flutter undergoing cardioversion, our primary aim is to determine the impact of the heart rate measurement, irregular rhythm notification, and ECG features of the Apple Watch on quality of life and healthcare utilisation.Methods and analysisWe are conducting a prospective, open-label multicentre pragmatic randomised clinical trial, leveraging a unique patient-centred health data sharing platform for enrolment and follow-up. A total of 150 patients undergoing cardioversion for atrial fibrillation or atrial flutter will be randomised 1:1 to receive the Apple Watch Series 6 or Withings Move at the time of cardioversion. The primary outcome is the difference in the Atrial Fibrillation Effect on QualiTy-of-life global score at 6 months postcardioversion. Secondary outcomes include inpatient and outpatient healthcare utilisation. Additional secondary outcomes include a comparison of the Apple Watch ECG and pulse oximeter features with gold-standard data obtained in routine clinical care settings.Ethics and disseminationThe Institutional Review Boards at Yale University, Mayo Clinic, and Duke University Health System have approved the trial protocol. This trial will provide important data to policymakers, clinicians and patients about the impact of the heart rate, irregular rhythm notification, and ECG features of widely used personal digital devices on patient quality of life and healthcare utilisation. Findings will be disseminated to study participants, at professional society meetings and in peer-reviewed journals.Trial registration numberNCT04468321.

IntroductionImmune thrombocytopaenia (ITP) is an acquired disorder of low platelets and risk of bleeding. Although many children can be observed until spontaneous remission, others require treatment due to bleeding or impact on health-related quality of life. Standard first-line therapies for those who need intervention include corticosteroids, intravenous immunoglobulin and anti-D globulin, though response to these agents may be only transient. Eltrombopag is an oral thrombopoietin receptor agonist approved for children with chronic ITP who have had an insufficient response to corticosteroids, intravenous immunoglobulin or splenectomy. This protocol paper describes an ongoing open-label, randomised trial comparing eltrombopag to standard first-line management in children with newly diagnosed ITP.Methods and analysisRandomised treatment assignment is 2:1 for eltrombopag versus standard first-line management and is stratified by age and by prior treatment. The primary endpoint of the study is platelet response, defined as ≥3 of 4 weeks with platelets >50×109/L during weeks 6-12 of therapy. Secondary outcomes include number of rescue therapies needed during the first 12 weeks, proportion of patients who do not need ongoing treatment at 12 weeks and 6 months, proportion of patients with a treatment response at 1 year, and number of second-line therapies used in weeks 13-52, as well as changes in regulatory T cells, iron studies, bleeding, health-related quality of life and fatigue. A planned sample size of up to 162 randomised paediatric patients will be enrolled over 2 years at 20 sites.Ethics and disseminationThe study has been approved by the centralised Baylor University Institutional Review Board. The results are expected to be published in 2023.Trial registration numberNCT03939637.

Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs.

IntroductionDigital behavioural weight loss interventions have the potential to improve public health; however, these interventions are often not adequately tailored to the needs of the participants. This is the protocol for a trial that aims to determine the effectiveness and cost-effectiveness of the Choosing Health programme as a means to promote weight loss and weight loss maintenance among overweight/obese adults.Methods and analysisThe proposed study is a two-group randomised controlled trial with a nested interrupted time series (ITS) within-person design. Participants (n=285) will be randomly assigned to either the Choosing Health digital intervention or a control group. For intervention participants, ecological momentary assessment will be used to identify behavioural determinants for each individual in order to tailor evidence-based behaviour change techniques and intervention content.Control group participants will receive non-tailored weight loss advice via e-book and generic emails. The primary outcome is the mean difference in weight loss between groups at 6 months controlled for baseline. Secondary outcomes include blood pressure and percentage of body fat; self-reported measures of physical activity, sitting time, quality of life, cost and theory-derived correlates of weight loss. Secondary outcomes will be measured at baseline, 3, 6 and 12 months. The primary outcome for ITS will be daily weight loss plan adherence. Data will be analysed using regression and time series analyses.Ethics and disseminationEthics approval was granted by Faculty of Psychology, SWPS University of Social Sciences and Humanities, Wroclaw, Poland, approval number 03/P/12/2019. The project results will be disseminated through structured strategy implemented in collaboration with the Ministry of Health.Trial registration detailsThis trial was registered with www.clinicaltrials.gov; registration number NCT04291482.

IntroductionObesity is a major public health challenge and exacerbates economic disparities through employment discrimination and increased personal health expenditures. Financial incentives for weight management may intensify individuals' utilisation of evidence-based behavioural strategies while addressing obesity-related economic disparities in low-income populations. Trials have focused on testing incentives contingent on achieving weight loss outcomes. However, based on social cognitive and self-determination theories, providing incentives for achieving intermediate behavioural goals may be more sustainable than incentivising outcomes if they enhance an individual's skills and self-efficacy for maintaining long-term weight loss. The objective of this paper is to describe the rationale and design of the Financial Incentives foR Weight Reduction study, a randomised controlled trial to test the comparative effectiveness and cost-effectiveness of two financial incentive strategies for weight loss (goal directed vs outcome based) among low-income adults with obesity, as well as compared with the provision of health behaviour change resources alone.Methods and analysisWe are recruiting 795 adults, aged 18-70 years with a body mass index ≥30 kg/m2, from three primary care clinics serving residents of socioeconomically disadvantaged neighbourhoods in New York City and Los Angeles. All participants receive a 1-year commercial weight loss programme membership, self-monitoring tools (bathroom scale, food journal and Fitbit Alta HR), health education and monthly check-in visits. In addition to these resources, those in the two intervention groups can earn up to $750 over 6 months for: (1) participating in an intensive weight management programme, self-monitoring weight and diet and meeting physical activity guidelines (goal-directed arm); or (2) a ≥1.5% to ≥5% reduction in baseline weight (outcome-based arm). To maximise incentive efficacy, we incorporate concepts from behavioural economics, including immediacy of payments and framing feedback to elicit regret aversion. We will use generalised mixed effect models for repeated measures to examine intervention effects on weight at 6, 9 and 12 months.Ethics and disseminationHuman research protection committees at New York University School of Medicine, University of California Los Angeles (UCLA) David Geffen School of Medicine and Olive-View-UCLA Medical Center granted ethics approval. We will disseminate the results of this research via peer-reviewed publications, conference presentations and meetings with stakeholders.Trial registration numberNCT03157713.

INTRODUCTION: Aortic stenosis is a significant cause of morbidity and mortality in older patients. The advent of transcatheter aortic valve implantation (TAVI) offers an alternative to surgical aortic valve replacement for patients with severe symptomatic aortic stenosis who are at high or intermediate risk of adverse events. Existing evidence highlights the importance of frailty as a predictor of poor outcomes post-TAVI. The objective of this study is to review the operationalisation of frailty instruments for TAVI recipients and determine clinical outcomes and the change in quality of life in frail patients undergoing TAVI. METHODS AND ANALYSIS: Methods are reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 checklist. We will search relevant databases to identify published, completed but unpublished and ongoing studies. We will include studies of patients with aortic stenosis, diagnosed as frail and who underwent a TAVI procedure that report mortality, clinical outcomes or health-related quality of life. Retrospective or prospective cohort studies, randomised controlled trials and non-randomised controlled trials will be eligible for inclusion. Two researchers will independently screen articles for inclusion, with disagreements resolved by a third reviewer. One researcher will extract data with audit by a second researcher. The risk of bias in studies will be evaluated using the Quality in Prognosis Studies tool. Meta-analysis of mortality, survival curve and the change in quality of life will be performed if appropriate. Subgroup analysis, sensitivity analysis and meta-regression will be performed if necessary. ETHICS AND DISSEMINATION: Due to the nature of this study, no ethical issues are foreseen. We will disseminate the results of our systematic review through a peer-reviewed journal. TRIAL REGISTRATION NUMBER: CRD42018090597.

INTRODUCTION:Approximately 400 000 Americans and 36 000 Canadians undergo cardiac surgery annually, and up to 56% will develop chronic postsurgical pain (CPSP). The primary aim of this study is to explore the association of pain-related beliefs and gender-based pain expectations on the development of CPSP. Secondary goals are to: (A) explore risk factors for poor functional status and patient-level cost of illness from a societal perspective up to 12 months following cardiac surgery; and (B) determine the impact of CPSP on quality-adjusted life years (QALYs) borne by cardiac surgery, in addition to the incremental cost for one additional QALY gained, among those who develop CPSP compared with those who do not. METHODS AND ANALYSES:In this prospective cohort study, 1250 adults undergoing cardiac surgery, including coronary artery bypass grafting and open-heart procedures, will be recruited over a 3-year period. Putative risk factors for CPSP will be captured prior to surgery, at postoperative day 3 (in hospital) and day 30 (at home). Outcome data will be collected via telephone interview at 6-month and 12-month follow-up. We will employ generalised estimating equations to model the primary (CPSP) and secondary outcomes (function and cost) while adjusting for prespecified model covariates. QALYs will be estimated by converting data from the Short Form-12 (version 2) to a utility score. ETHICS AND DISSEMINATION:This protocol has been approved by the responsible bodies at each of the hospital sites, and study enrolment began May 2015. We will disseminate our results through CardiacPain.Net, a web-based knowledge dissemination platform, presentation at international conferences and publications in scientific journals. TRIAL REGISTRATION NUMBER:NCT01842568.

INTRODUCTION: Emergency department (ED)-initiated palliative care has been shown to improve patient-centred outcomes in older adults with serious, life-limiting illnesses. However, the optimal modality for providing such interventions is unknown. This study aims to compare nurse-led telephonic case management to specialty outpatient palliative care for older adults with serious, life-limiting illness on: (1) quality of life in patients; (2) healthcare utilisation; (3) loneliness and symptom burden and (4) caregiver strain, caregiver quality of life and bereavement. METHODS AND ANALYSIS: This is a protocol for a pragmatic, multicentre, parallel, two-arm randomised controlled trial in ED patients comparing two established models of palliative care: nurse-led telephonic case management and specialty, outpatient palliative care. We will enrol 1350 patients aged 50+ years and 675 of their caregivers across nine EDs. Eligible patients: (1) have advanced cancer (metastatic solid tumour) or end-stage organ failure (New York Heart Association class III or IV heart failure, end-stage renal disease with glomerular filtration rate

IntroductionPreliminary evidence supports the beneficial role of physical activity on prostate cancer outcomes. This phase III randomised controlled trial (RCT) is designed to determine if supervised high-intensity aerobic and resistance exercise increases overall survival (OS) in patients with metastatic castrate-resistant prostate cancer (mCRPC).Methods and analysisParticipants (n=866) must have histologically documented metastatic prostate cancer with evidence of progressive disease on androgen deprivation therapy (defined as mCRPC). Patients can be treatment-naïve for mCRPC or on first-line androgen receptor-targeted therapy for mCRPC (ie, abiraterone or enzalutamide) without evidence of progression at enrolment, and with no prior chemotherapy for mCRPC. Patients will receive psychosocial support and will be randomly assigned (1:1) to either supervised exercise (high-intensity aerobic and resistance training) or self-directed exercise (provision of guidelines), stratified by treatment status and site. Exercise prescriptions will be tailored to each participant's fitness and morbidities. The primary endpoint is OS. Secondary endpoints include time to disease progression, occurrence of a skeletal-related event or progression of pain, and degree of pain, opiate use, physical and emotional quality of life, and changes in metabolic biomarkers. An assessment of whether immune function, inflammation, dysregulation of insulin and energy metabolism, and androgen biomarkers are associated with OS will be performed, and whether they mediate the primary association between exercise and OS will also be investigated. This study will also establish a biobank for future biomarker discovery or validation.Ethics and disseminationValidation of exercise as medicine and its mechanisms of action will create evidence to change clinical practice. Accordingly, outcomes of this RCT will be published in international, peer-reviewed journals, and presented at national and international conferences. Ethics approval was first obtained at Edith Cowan University (ID: 13236 NEWTON), with a further 10 investigator sites since receiving ethics approval, prior to activation.Trial registration numberNCT02730338.

Background and Objectives: Violence against women (VAW) is widespread and can have serious physical and mental health consequences, including post-traumatic stress disorder (PTSD) and sleep disorders. Victim-survivors often face barriers in accessing specialised care, highlighting the need for a multidisciplinary response, especially in healthcare settings. The Maison des Femmes (MdF) model provides holistic support to women experiencing VAW, including medical, psychological, social and legal support. The aim of this study is to examine whether the MdF's comprehensive intervention programme offers advantages over standard care in improving mental health indicators, such as PTSD., Method and Analysis: Our pragmatic quasi-experimental study uses a non-randomised controlled cluster design. The intervention group comprises women enrolled in MdFs in five French cities, while the comparison group includes women receiving usual care in sociomedical structures located geographically close to MdF centres. Our study aims to recruit 360 women (180 per group), aged 18 years or older, who have experienced intimate partner violence or sexual violence and who seek care at the study centres. The primary analysis will compare the change in PTSD Checklist for DSM-5 (PCL-5) scores over 6 months in the two groups using multivariable linear regression with propensity score adjustment. Secondary outcomes include sleep disorders, quality of life, symptoms of anxiety and depression, self-esteem, sense of safety and well-being, initiation of legal and socioprofessional proceedings, and healthcare utilisation., Ethics and Dissemination: The study was approved by the 'Comité de protection des personnes Ile de France III' (CPP Committee for the Protection of Persons Ile de France III; institutional review board on 20 December 2023; Ref no. (Numéro SI): 23.04197.000491).The results of the study will be communicated via academic publications; easily understandable briefs for a broader public; and proactive involvement with medical institutions, journalists and advocacy groups., Trial Registration Number: NCT06226818. Version Number 1- february2024., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: People with cancer and other chronic illnesses, their families and caregivers report financial burden as a problem that affects multiple aspects of daily life. While cancer research has coined the term 'financial toxicity' to describe the financial consequences, the understanding, development and operationalisation of the concept of financial burden are still incomplete, particularly regarding subjective financial burden and its relationship with well-being. The overall aim is to investigate financial burden and its implications for the well-being of people living with chronic illness, their families, and caregivers in Switzerland., Methods and Analysis: Transdisciplinary discussion groups and a participatory action design element frame: (1) a conceptualisation using a hybrid concept analysis approach and (2) an assessment of financial burden of chronic illness in relation to well-being. The hybrid concept analysis combines the results of a scoping review with a secondary analysis of existing interviews using computational linguistics and qualitative analysis. The assessment phase will investigate the extent and nature of financial burden through a nationwide survey. Results from mobile diaries/interviews will contribute to both-the conceptualisation and assessment phases., Ethics and Dissemination: The Ethics Committee of the Canton Zurich, Switzerland, did not consider the research project to fall under the Swiss Law on Human Subjects research and issued a waiver (Req-2O23-01496). The project respects all the rules and regulations in the Swiss Federal Act on Data Protection and those by the Swiss Federal Official Responsible for Data Protection and Transparency. Results will be disseminated through presentations at conferences and publications in peer-reviewed journals and through the established multi-stakeholder network., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Autism is a lifelong neurodevelopmental condition diagnosed on the basis of differences in social communication, interaction and repetitive behaviours, including sensory sensitivities. Autistic individuals without intellectual disabilities often face barriers to positive adult outcomes and are at high risk for poor health, including mental health issues, which could be mitigated by improving well-being. Young people should receive support to increase their well-being during the transition to adulthood, when social and family support often reduces. This is the protocol for a feasibility randomised controlled trial (RCT) of an online peer-group intervention, 'Understanding You, Discovering You' (UYDY). Objectives included assessing recruitment and retention rates, acceptability of procedures, characterising usual care, assessing the acceptability of UYDY and care as usual (CAU) and calculating outcome measure variances for a full trial., Methods and Analysis: This two-arm parallel feasibility RCT includes a nested qualitative evaluation. Seventy participants aged 16-25 years old with a clinical autism diagnosis will be randomised on a 1:1 basis to UYDY or CAU. Exclusion criteria include risk of harm to self or others, receipt of postdiagnostic support in the past 12 months, and literacy levels such that the written session materials are not accessible. UYDY, a 6-week online peer-group intervention, will cover topics such as understanding autism, problem-solving and accessing services, and is facilitated by an autistic person and social care professionals. The main outcomes from the feasibility trial will be collecting data on (1) recruitment and retention rates; (2) the acceptability of randomisation and outcome measurement procedures; (3) CAU accessed by participants; (4) acceptability of the interventions; (5) clinical outcome measure variances (see below). See the Statistical methods section below for how this will be assessed in the current study. Clinical outcomes will be measured at baseline, and 8, 16 and 24 weeks post-randomisation. The primary clinical outcome is well-being, assessed using the Warwick Edinburgh Mental Wellbeing Scale. Secondary clinical outcomes include autism social identification, quality of life, social support and loneliness. Adverse events will be monitored and reported. Carer impact will also be measured. Participants will be recruited from England and Wales via charities and NHS services. Qualitative interviews will be conducted to explore the acceptability of trial participation including randomisation and the interventions., Ethics and Dissemination: Ethical approval has been obtained from the HRA and NHS REC (23/WA/0113). Informed consent will be collected from all participants (see online supplemental material for an example consent form). Results will inform the design of a full RCT and will be disseminated through peer-reviewed journals, conferences, and stakeholder events., Trial Registration Number: ISRCTN10513626., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Evidence shows that resistance training (RT) reduces lymphoedema in patients with breast cancer-related lymphoedema (BRCL), making it a safe and efficient intervention. However, it is uncertain if RT is safe and effective in patients at risk of developing BRCL. This systematic review (SR) protocol aims to describe all methodological aspects in order to evaluate the short-, medium- and long-term effects of RT on the prevention of BCRL., Materials and Methods: Throughout 2024, randomised clinical trials (RCTs) will be identified in electronic databases MEDLINE/PubMed, Embase, Cochrane Central Register of Controlled Trials, PEDro and LILACS. Only studies in English, Spanish and Portuguese will be included. Grey literature and clinical trial registration will also be reviewed. The primary outcome will be the occurrence of lymphoedema and quality of life. Second, pain intensity, upper limb function, range of movement, grip strength and adverse events will be considered. The individual studies' risk of bias will be evaluated using the Cochrane Risk of Bias 2.0 tool. Pairwise meta-analyses using a frequentist approach and random effects model will be conducted. The Grading of Recommendations Assessment, Development and Evaluation system will be used to evaluate the certainty of the evidence., Ethics and Dissemination: This protocol does not require the approval of an ethics committee, as it is a secondary study. The results will be disseminated through peer-reviewed publications., Prospero Registration Number: CRD42023455720., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Routine collection of patient-reported outcome measures (PROMs) has the potential to inform and improve cancer care. It is now feasible for patients to complete PROMs electronically (ePROMs) providing information about their current levels of symptoms, side effects of treatment and other concerns. PROM scores can be tracked over time allowing more timely identification of problems and more appropriate intervention. Studies have reported clear benefits in patient-clinician communication when PROMs are used and trials in the USA and France found patients randomised to complete regular ePROMs reported better health-related quality of life, had fewer unplanned hospital visits and, importantly, significantly better survival than those randomised to usual care. However, information about the effects on health outcomes and, particularly, the cost-effectiveness of incorporating this information into practice is limited., Methods and Analysis: PROMISE (Patient Reported Outcome Measures in cancer care: a hybrid effectiveness-Implementation trial to optimise Symptom control and health service Experience) is a multicentre, randomised hybrid effectiveness/implementation trial to evaluate the clinical and cost-effectiveness of using ePROMs in routine cancer care to improve patient outcomes. Participants (target sample=572; randomised 1:1 to intervention and control) are adults aged 18 years or older diagnosed with a solid cancer and starting treatment at one of the four study hospitals. The primary outcomes are unplanned hospital presentations and physical/functional well-being at 6 months. We hypothesise that, compared with usual care, patients randomised to use an ePROM tool will have fewer unplanned hospital presentations, report better health-related quality of life and greater satisfaction with their care and that the ePROM tool will be cost-effective. We will also assess implementation and process outcomes consistent with the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) Framework., Ethics and Dissemination: This trial has been approved by the Metro South Human Research Ethics Committee (HREC/2020/QMS/67441). Participants provide written informed consent, including consent for record linkage, prior to completing the baseline questionnaire. Study results will be disseminated via peer-reviewed journals and presentations at scientific conferences and clinical meetings., Trial Registration Number: ACTRN12620001290987., Competing Interests: Competing interests: PMW has received a speaker’s fee from AstraZeneca (December, 2021). ME and DW were part of the Metro North Health team that developed AboutMe and BB and LRW were part of the PAH team that developed My Health My Way but neither tool has been commercialised and none of the authors have any financial interests in the tools. RL has received grant funding from MSD for an unrelated study and sits on Advisory Boards for/has received honoraria and travel funding from MSD, L’Oreal and Sanofi. BB has been a member of the Metro South Human Research Ethics Committee since 2018 but was not involved in the review of this study., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To investigate the prevalence, associated factors, treatment status and burden of constipation in workers with depression or anxiety., Study Design: This was a retrospective observational study using a pre-existing database., Setting: Claims data from October to November 2022 and data from the survey conducted in November 2022 were extracted from the database., Participants: This study included self-reported workers who completed the survey, after excluding those with major mental disorders diagnosed as distinct from depression or anxiety and constipation due to organic diseases identified by International Classification of Diseases (ICD-10) codes., Outcome Measures: The subjects were divided into three groups: treated depression/anxiety, untreated depression/anxiety and no depression/anxiety. The prevalence of constipation, factors associated with constipation and medications prescribed for constipation were analysed. Work productivity and quality of life (QOL) were compared between three subgroups based on constipation status: treated constipation, untreated constipation and no constipation subgroup., Results: Of the 18 585 respondents in the analysis population, 950 respondents (5.1%) were classified into the treated depression/anxiety group, 6035 respondents (32.5%) into the untreated depression/anxiety group and the remaining respondents into the no depression/anxiety group (11 600 (62.4%)). The prevalence of constipation was 22.5% in the treated group, 22.3% in the untreated group and 10.4% in the no depression/anxiety group, respectively. Depression and anxiety severity were independently associated with an increased risk of constipation. In all groups, the most commonly prescribed drug class was osmotic laxatives. Work productivity and QOL tended to indicate a greater burden in the untreated constipation subgroup than in the treated or no constipation subgroups., Conclusions: The prevalence of constipation was twice as high if workers had depression/anxiety. Considering that the comorbidity of constipation with mental disorders may increase multiple burdens, appropriate medical interventions are required to treat both mental (depression/anxiety) and physical (constipation) conditions. This should be widely recognised by physicians and employers., Competing Interests: Competing interests: YK, KNoz, and KNom are employees of Viatris Pharmaceuticals Japan Inc. SF declares lecture fees from Viatris Pharmaceutical during the conduct of the study and they had no relation to this study. Relationship between Dr. SF and Viatris Pharmaceutical was officially approved by the bureau of conflict of interest management of Tohoku University., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Depression is three to four times more prevalent in autistic people and is related to reduced quality of life. There is a need for empirically supported psychological interventions for depression specifically adapted to meet the needs of autistic adults. ADEPT-2 aims to establish the clinical and cost-effectiveness of an adapted low-intensity psychological intervention (guided self-help) for depression in autistic adults., Methods and Analysis: A two parallel-group multicentre pragmatic randomised controlled trial investigating the effectiveness of GSH for depression in autistic adults. Participants (n=248) aged ≥18 years with a clinical diagnosis of autism currently experiencing depression will be randomised to GSH or treatment as usual (TAU). GSH is a low-intensity psychological intervention based on the principles of behavioural activation adapted for autism. GSH comprises informational materials for nine individual sessions facilitated online by a GSH coach who has received training and supervision in delivering the intervention. The primary outcome will be Beck Depression Inventory-II depression scores at 16 weeks post randomisation with follow-up measures at 32 and 52 weeks. Additional measures of anxiety, patient-rated global improvement, quality of life, work and social adjustment, positive and negative affect will be measured 16 and 52 weeks post randomisation. The primary health economic analysis will assess the cost-effectiveness of GSH compared with TAU over 52 weeks, from a societal perspective including the National Health Service, personal social services, personal expenses, voluntary services and productivity. An embedded qualitative study will explore the acceptability, experiences and adherence of participants and therapists to treatment principles., Ethics and Dissemination: This trial has been approved by the East of England - Essex Research Ethics Committee on 10 June 2022 (REC Reference number: 22/EE/0091). The findings of the research will be submitted for publication in peer-reviewed journals and disseminated in an appropriate format to trial participants and the wider public., Trial Registration Number: ISRCTN17547011., Competing Interests: Competing interests: PL is a member of the Board of Directors for the International Association for the Scientific Study of Intellectual and Developmental Disability. CM receives grant funding from University of Bristol from UK National Institute for Health and Care Research, Health Technology Assessment Programme. DR reports funding for autism and mental health research awarded to the University of Bristol from a range of public and charity funders. He is the chief investigator of the STRATA trial (NIHR127337). There are no other competing interests from the authors., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Purpose: The current study aimed to investigate the associations between metabolic syndrome (MetS) with health-related quality of life (HRQoL) using multilevel analysis among the Iranian adult population., Methods: This cross-sectional study was conducted in the framework of the Tehran Lipid and Glucose Study (TLGS). Participants were 6113 participants (3318 women and 2795 men) aged≥20 years of the TLGS seventh phase who had completed data on HRQoL and MetS. HRQoL was assessed using the short-form 12-item health survey V.2 and MetS defined based on the guidelines outlined in the Joint Interim Statement. The two-level model was fitted to assess the association between MetS and HRQoL., Results: The prevalence of MetS and its components was higher in men, and regardless of metabolic status, men exhibited higher HRQoL values. The deleterious impact of MetS on HRQoL was more pronounced in women, while the detrimental effects of MetS on men's HRQoL were confined to specific subscales. These results were obtained through multilevel analysis, considering both familial and individual variation levels. Moreover, our investigation highlighted the positive influence of leisure-time physical activity on both the physical and mental component summaries (PCS and MCS, respectively), regardless of gender. Education had a greater positive impact on PCS in both sexes. Additionally, a history of cardiovascular diseases was associated with a decline in mental and physical HRQoL, while age was linked to a decline in PCS and MCS, and smoking was associated with a decline in MCS., Conclusion: This study revealed the significant influence of gender, as well as the unique characteristics and circumstances of individuals, on the relationship between MetS and HRQoL in a general population with low/middle income., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Life satisfaction is a key indicator of successful ageing and reflects well-being. There is evidence of the association between life satisfaction and health behaviours among older adults. Therefore, this systematic review and meta-analysis protocol seeks to determine the strength and direction of the association between life satisfaction and health behaviours among older adults., Methods and Analysis: This protocol followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. We will search the electronic databases (MEDLINE, APA PsycINFO, Web of Science, CINAHL and Global Health) from inception to date. Only observational studies that described the association between life satisfaction and health behaviours-smoking, alcohol drinking, physical activity, diet/nutrition and sleep-will be included. Two independent reviewers will conduct screening, data extraction and risk of bias assessment of the articles. The risk of bias will be assessed using the Joanna Briggs Institute critical appraisal tools for cohort and analytical cross-sectional studies. Studies will be included in the meta-analysis if they report zero-order associations between life satisfaction and health behaviours; otherwise, a narrative synthesis will be presented., Ethics and Dissemination: This study does not require ethics approval, as it involves analysing secondary data from published studies. The completed review will be published in a peer-reviewed journal and presented at conferences., Trial Registration Number: PROSPERO (CRD42023441386)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Healthcare workers (HCWs) have been of particular relevance for overcoming the SARS-CoV-2 pandemic. At the same time they have been affected by SARS-CoV-2 infections with above average probability. Around 6.5% of the overall infected persons are likely to develop persistent symptoms resulting from the infection, known as long-COVID or post-COVID syndrome (PCS). The aim of this study is (1) to investigate the prevalence, course and characteristics of PCS in German HCWs, (2) to examine its effects on psychosocial variables, (3) to identify rehabilitation and healthcare needs and (4) to analyse treatment experiences., Methods and Analysis: In a cohort study with a randomised selection of participants (N=20 000) from the Employer's Liability Insurance Association for Health and Welfare Care, the health status of HCWs, who had COVID-19 in their professional context will be examined. There will be two measurement points: baseline (T 1 ) and a 12-month follow-up (T2). The outcome measures are the health status with a particular focus on persistent or newly occurring symptoms after a SARS-CoV-2 infection, health-related quality of life, functional capacity, the subjective need for and utilisation of healthcare services. Pre-existing conditions, the course of the acute infection and sociodemographic factors are considered as predictors. An advisory board made up of affected HCWs supports the study by contributing to the surveys' contents., Ethics and Dissemination: The study has been approved by the Local Ethics Committee of the Center for Psychosocial Medicine at the University Hospital Hamburg-Eppendorf (LPEK-0518). For dissemination, the results will be published in peer-reviewed journals, presented at conferences and communicated to relevant stakeholders in general and rehabilitation medicine., Trail Registration Number: https://drks.de/search/de/trial/DRKS00029314., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Somatic symptom disorder (SSD) is a distressing mental disorder characterised by the presence of at least one persistent somatic symptom and a significant psychological burden due to the symptom(s), as well as excessive thoughts, feelings or behaviours related to them or associated health concerns. The primary aim of our study is to deepen the understanding of risk factors and mechanisms for somatic symptom persistence. Specifically, we will investigate the role of patients' expectations and somatic comorbidity regarding symptom persistence., Methods and Analysis: In a prospective 12-month cohort study, n=240 patients with SSD will be recruited from the outpatient clinics of the Department of Psychosomatic Medicine and Psychotherapy at the University Medical Center Hamburg-Eppendorf. The roles of two hypothesised predictors (ie, expectations and comorbidity) will be analysed together with known predisposing and maintaining factors of persistent somatic symptoms. The study entails macrolevel and microlevel assessments to investigate symptom severity over different timespans. Assessments at the macrolevel take place at baseline, 6 and 12 months. At the microlevel, a 10-day ecological momentary assessment study will be implemented to elucidate patients' dynamic experience with somatic symptoms in their natural environments. In order to elicit possible framing effects on the 10-day course of symptom severity, participants are randomised to either a positive or a negative expectation framing group. Cross-lagged panel models will be used to analyse data at the macrolevel. At the microlevel, multivariate latent growth curve models will be conducted to relate temporal changes in predictor and outcome variables to one another., Ethics and Dissemination: The study was approved by the Ethics Committee of the Medical Associations Hamburg, Germany (2020-10197-BO-ff). The results will enable us to draw conclusions regarding the role of expectations for future targeted treatment options and regarding the utility of somatic comorbidity as a potential diagnostic specifier of SSD. Dissemination of our results will be achieved through scientific publications, and lay summaries for study participants, patient advocacy groups and the general public., Trial Registration Number: ISRCTN36251388., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This systematic review aims to evaluate the methodology used in pancreatic cancer (PC) randomised controlled trials (RCTs) measuring quality of life (QOL) and focuses on the type, frequency, survey compliance and duration of these assessments., Design: Systematic review of PC RCTs measuring QOL., Data Sources: A search of PubMed.gov and ClinicalTrials.gov was conducted for PC RCTs measuring QOL from inception to 21 March 2023. Only phase III RCTs were included. Studies were excluded if QOL was not measured, the study was phase I/II, in the second-line setting or unavailable in English. Data were independently extracted by two reviewers in a standardised fashion., Primary and Secondary Outcome Measures: Primary outcomes included the type of QOL instrument used, the timing and frequency of assessments, methods of analysis and survey completion rates (SCRs) over time. Secondary outcomes included patient demographics, significant QOL improvements and the frequency of trials measuring QOL., Results: Out of 269 studies screened, 54 RCTs were identified, and 24 measured QOL (involving 11 229 patients). Instruments used included the EORTC QLQ-C30 (n=15), FACT-HEP (n=3), Spitzer-QOL-Index (n=2), EQ-5D (n=2), LASA (n=1) and FACT-PA (n=1). Most trials assessed QOL until disease progression or death (10/24), with 4-week intervals being the most common (7/24). SCRs were reported in 15/24 trials, with disease stage influencing SCRs over time. In trials with metastatic, locally advanced/metastatic, and resectable disease, the median times to reach a 50% response rate-defined as the point where the number of surveys completed was half of the enrolled participants-were 12.41 weeks (n=2), 14.14 weeks (n=10), and 54.2 weeks (n=3), respectively." Only 2/24 trials reported significant QOL improvements between treatment arms. Patient age was reported in all trials, while race/ethnicity was only reported in 4/24 trials., Conclusions: Significant variability exists in the timing, methods and reporting of QOL assessments in PC trials. There is a need for further research to assess the implications of missing data and consider the temporality of QOL assessment in patients with advanced cancers and poor prognosis., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Musculoskeletal joint complaints (MSCs) are the most common extraintestinal manifestation of inflammatory bowel disease (IBD). We aimed to investigate the effect of MSC on the health-related quality of life (QoL) in patients with IBD., Design: A survey-based cross-sectional study among adult Dutch IBD patients., Setting: Primary care, secondary care and patient association., Participants: In total, 635 IBD patients were included. The mean age was 46.3 (SD 14.2) years, and 35% were male., Outcome: MSC was defined as suffering from any joint complaints. QoL was measured using the IBD questionnaire and a 36-item short form health survey questionnaire., Methods: A univariate analysis was performed to estimate the impact of various factors, such as demographic characteristics, setting, type of IBD and fatigue, which was followed by a multiple regression analysis to adjust for the confounding factors., Results: Of the 635 IBD patients, 332 suffered from Crohn's disease (CD) and 303 from ulcerative colitis (UC). After adjusting for confounding factors, MSC was independently associated with reduced QoL among IBD patients (β=-10.6, 95% CI -15.2 to -6.1), both in CD (β=-8.3, 95% CI -14.6 to -2.1) and UC (β=-13.9, 95% CI -20.5 to -7.3). 11% of the IBD patients had a rheumatological diagnosis. QoL in these patients was significantly lower compared with IBD patients with non-rheumatological MSC., Conclusions: IBD patients with MSC are associated with a lower QoL, explicitly in patients with a rheumatological diagnosis. Prospective research is necessary to evaluate the causality and suitable interventions to increase QoL in these multimorbid patients., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Atrial fibrillation (AF) is the prevalent cardiac arrhythmia and can significantly impair the quality of life (QoL). Although catheter ablation (CA) is an established treatment for AF,post-procedural complications or perceived inadequate control of AF may diminish the QoL for some patients, potentially even to levels lower than pre-procedure. Preliminary findings from our previous pilot trial indicate that acupuncture may positively influence QoL in AF patients post-CA. This study aims to increase the sample size to evaluate the efficacy of acupuncture as an adjunctive treatment to conventional medical therapy in improving QoL of patients with AF after CA., Methods and Design: This multicentre randomised clinical trial will be conducted in China. A total of 146 eligible patients will be randomly assigned in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. All patients will receive standard postablation care and undergo 18 sessions of acupuncture/sham acupuncture within 12 weeks following CA, followed by a 9-month follow-up period. The primary outcome is the change in the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) summary score from baseline to months 6 after CA. Secondary outcomes include the changes in the AFEQT subscale scores at months 6, the AFEQT summary and subscale score at months 3 and 12, AF burden, AF recurrence, heart rate variability, number of cardioversions, repeat CA procedures, European Heart Rhythm Association score, number of arrhythmia-related hospitalisations, average heart rate, use of Six-Dimensional Health State Short Form to assess health status, costs incurred by disease treatment, Credibility/Expectancy Questionnaire and blinded assessments. Adverse events will also be meticulously recorded throughout the trial., Ethics and Dissemination: Ethics approval has been granted by the Ethics Committee of Beijing University of Traditional Chinese Medicine (approval no: 2020BZYLL0802) and seven other subcentres. The findings of the study results will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals., Trial Registration Number: ChiCTR2100049323., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To assess the effect of goal-directed mobilisation (GDM) on physical functioning in medical inpatients., Design: Randomised, controlled, single-centre, parallel, superiority trial with a 3-month follow-up and blinded outcome assessment., Setting: General internal medicine wards of a Swiss tertiary acute hospital, September 2021 to April 2023., Participants: Adults with expected hospitalisation of ≥5 days, physiotherapy prescription and ability to follow study procedures., Intervention: GDM during hospitalisation, which includes personal goal setting and a short session of patient education through a physiotherapist (experimental group), versus standard care (control group)., Outcome Measures: The primary outcome was the change in physical activity between baseline and day 5 (De Morton Mobility Index (DEMMI)). Secondary outcomes included in-hospital accelerometer-measured mobilisation time; in-hospital falls; delirium; length of stay; change in independence in activities of daily living, concerns of falling and quality of life; falls, readmission and mortality within 3 months., Results: The study was completed by 123 of 162 (76%) patients enrolled, with the primary outcome collected at day 5 in 126 (78%) participants. DEMMI Score improved by 8.2 (SD 15.1) points in the control group and 9.4 (SD 14.2) in the intervention group, with a mean difference of 0.3 (adjusted for the stratification factors age and initial DEMMI Score, 95% CI -4.1 to 4.8, p=0.88). We did not observe a statistically significant difference in effects of the interventions on any secondary outcome., Conclusions: The patient's physical functioning improved during hospitalisation, but the improvement was similar for GDM and standard of care. Improving physical activity during an acute medical hospitalisation remains challenging. Future interventions should target additional barriers that can be implemented without augmenting resources., Trial Registration Number: NCT04760392., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Sleep-disordered breathing affects 1.6 million people in the UK. The recognised treatment is positive airway pressure (PAP) therapy, delivered via a generic conventional interface (mask). PAP therapy improves morbidity, mortality and quality of life, but treatment effectiveness depends on interface fit and tolerance. Interface side effects include pressure ulcers, skin reactions and interface leak. Three-dimensional (3D) printing is an innovative technology that can produce customised interfaces., Aims: The primary aim is to assess the impact of customised versus conventional interfaces on residual Apnoea Hypopnea Index at 6 months., Methods and Analysis: This is a randomised control trial via block randomisation, minimised by age >65 and ethnicity, using a computerised random number generator. Patients with sleep-disordered breathing under the care of the Royal Free London NHS Foundation Trust will be recruited. Patients new to therapy will be randomised to customised interface or conventional interface for 6 months. A sample size of 160 is required for 80% power with a significance of 5%, accounting for a 20% dropout rate. Descriptive statistics will report demographics. The primary and secondary outcomes will be compared using linear regression adjusted for baseline score., Ethics and Dissemination: This protocol has been approved by the Hampshire B Research Ethics Committee (REC reference: 22/SC/0405). Results will be disseminated to healthcare professionals and patients through conferences, open-access journals, newsletters, a study webpage, infographics, animations, social media and healthcare awards., Isrctn Registration Number: 74082423., Competing Interests: Competing interests: SKM: consultancy for Philips Respironics, educational grants from Philips Respironics and Dolby Vivisol, Research grants from Philips Respironics. SM: consultancy for Philips Respironics, educational grants from Dolby Vivisol., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Pain is one of the most debilitating symptoms of cancer, substantially diminishing one's quality of life. The level of pain experienced is eventually determined by the pain coping strategies adopted by patients individually. The awareness of the 'self-coping methods of pain' of individual patients would be beneficial for the multidisciplinary pain team to consider such methods when planning future interventions to manage pain., Objectives: This study explores the pain perception and coping strategies used by patients with cancer pain in Sri Lanka., Design: A descriptive qualitative study., Setting: Pain management unit, Apeksha Hospital, Maharagama, Sri Lanka., Participants: The study was conducted among purposively selected patients with cancer and registered at the pain management unit. 21 semi-structured interviews were conducted until data saturation. Data were analysed using Graneheim and Lundman's content analysis method., Results: Most participants were between 51 and 60 years old and identified as Sinhalese Buddhists. The study's findings revealed two subthemes under 'Understanding pain', namely 'Physical and emotional impact' and 'Cultural and spiritual interpretations', and five subthemes under 'Coping strategies for living with pain', namely 'Medication and self-control', 'Seeking spiritual support', 'Receiving social support', 'Exploring alternative treatments' and 'Adapting daily life'., Conclusion: Coping strategies were adopted especially in achieving essential life aspirations and participating in preferred activities. Goals or activities were often adjusted to fall within their health limits. Acceptance and progress in life were considered more important than pain control. We recommend giving due consideration to the 'self-coping strategies' of individual patients in designing interventions to mitigate cancer pain., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Teleworking is one of the most significant legacies of the pandemic. Great attention is now being paid to its effects on workers' health. One of the arguments that emerged on this issue is that 'working away from the office' affects the time we spend with significant others. This calls into question all those processes that make relatives and colleagues important to our health, such as forms of mentoring and social support, but also conflicts, work interruptions or control over workers' activities. So far, no study has evaluated the impact that teleworking has on these processes using data on personal networks. The Empty Office is the first study to use social network analysis to measure the impact that telework has on social relations and, in turn, workers' health and well-being., Methods and Analysis: The project draws on a total sample of 4400 participants from Switzerland, the Netherlands, Spain and Germany (n=1100 per country). The choice of these countries is due to their specificity and diversity in socioeconomic features, which make them particularly interesting for studying teleworking from a comparative point of view. The research is conceived as a sequential mixed-method design. First, quantitative data collection will administer an online questionnaire to gather information on telework modalities, health and well-being markers, and data on personal networks collected by a name generator. A qualitative module, administered one year later, will consist of in-depth interviews with a subsample (n=32) of teleworkers selected for delving narratively into the mechanisms identified with the quantitative analyses., Ethics and Dissemination: This study has obtained 2 years of funding from the Swiss Network for International Study and was approved by the Ethics Committee of the University of Geneva (CUREG-20230920-292-2). All participants will be asked to provide informed consent to participate in this study. The results will be shared with international organisations and disseminated in scientific journals and conferences. Fully anonymised data will be made available on the Open Science Framework (OSF) data-repository platform., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To examine trajectories of functional limitations, fatigue, health-related quality of life (HRQL) and societal costs of patients referred to long COVID clinics., Design: A population-based longitudinal cohort study using real-time user data., Setting: 35 specialised long COVID clinics in the UK., Participants: 4087 adults diagnosed with long COVID in primary or secondary care deemed suitable for rehabilitation and registered in the Living With Covid Recovery (LWCR) programme between 4 August 2020 and 5 August 2022., Main Outcome Measures: Generalised linear mixed models were fitted to estimate trajectories of functional limitations, using the Work and Social Adjustment Scale (WSAS); scores of ≥20 indicate moderately severe limitations. Other outcomes included fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) reversed score (scores of ≥22 indicate impairment), HRQL using the EQ-5D-5L, and long COVID-related societal costs, encompassing healthcare costs and productivity losses., Results: The mean WSAS score at 6 months after registration in the LWCR was 19.1 (95% CI 18.6, 19.6), with 46% of the participants (95% CI 40.3%, 52.4%) reporting a WSAS score above 20 (moderately severe or worse impairment). The mean change in the WSAS score over the 6-month period was -0.86 (95% CI -1.32, -0.41). The mean reversed FACIT-F score at 6 months was 29.1 (95% CI 22.7, 35.5) compared with 32.0 (95% CI 31.7, 32.3) at baseline. The mean EQ-5D-5L score remained relatively constant between baseline (0.63, 95% CI 0.62, 0.64) and 6 months (0.64, 95% CI 0.59, 0.69). The monthly societal cost per patient related to long COVID at 6 months was £931, mostly driven by the costs associated with working days lost., Conclusions: Individuals referred to long COVID clinics in the UK reported small improvements in functional limitations, fatigue, HRQL and ability to work within 6 months of registering in the LWCR programme., Competing Interests: Competing interests: KB's research portfolio is partly funded by National Institute for Health & and Care Research (NIHR) Applied Research Collaboration Wessex. HG reports working as a clinical safety officer for Living With. JRH reports receiving personal fees and fees to institution for honorariums and consultancy payments from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline and Takeda, and also sponsorship for attending meetings from AstraZeneca and GlaxoSmithKline. PP reports grants from the Medical Research Council and NIHR outside the submitted work. All other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Cancer-related fatigue (CRF) is one of the most common and painful symptoms in patients with prostate cancer (PCa). Moreover, PCa patients who receive the androgen deprivation therapy (ADT) are more likely to develop CRF. Baduanjin exercise has been shown to improve CRF in some cancers. However, such effects have not been verified in patients with PCa treated with the ADT. So, this study was designed as a randomised controlled trial (RCT) to explore the effects of Baduanjin exercise on CRF in PCa patients treated with the ADT., Methods and Analysis: This study will be a single-centre, assessor and statistician blinded, RCT consisting of a 12 week intervention and 12 week follow-up. Patients with PCa who meet the inclusion criteria will be recruited from Shanghai Hudong Hospital. Participants will be randomly assigned to Baduanjin exercise group (n=42) and the control group (n=42), performing 12 weeks of Baduanjin exercise or reeiving the standard care. The primary outcome will be the clinical effect of Baduanjin exercise on CRF in PCa patients, which will be measured using the Piper Fatigue Self-Assessment (PFS) scale, a multidimensional measure of CRF using three different dimensions: somatic, emotional and cognitive. The secondary outcome will be the clinical effect of the Baduanjin exercise on the patient's level of fatigue, sleep, depression and life quality at the time, which will be assessed by the Brief Fatigue Inventory (BFI), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI) and the Functional Assessment of Cancer Therapy-Prostate (FACT-P)., Ethics and Dissemination: This study has been approved by Shanghai Hudong Hospital Ethics Committee, Shanghai province (2022 SHHDKY08). The trial results will be submitted to conferences and peer-reviewed journals., Trail Registration Number: ChiCTR2300074293., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Emotion dysregulation is a transdiagnostic characteristic that affects many people with many psychopathological problems. Two mechanisms that have been frequently associated with emotional regulation are immersion and distancing. Focusing is a task that combines these two mechanisms of emotion regulation through the phase of creating a working distance and subsequently the phase of reassigning meaning. However, the benefit of its use in Portuguese population without a moderate to severe symptomatology for promoting mental health remains unclear., Methods and Analysis: Participants aged between 18 and 65 years who wish to improve their awareness and understanding of their emotions will be recruited and then, randomised into two groups: the intervention group (IG) and the control group (CG; delayed intervention). The IG will have access to two focusing sessions and the CG will only have access to the intervention 4 weeks later. Both groups will be evaluated at five different times. Primary outcomes include positive and negative affect, attitudes towards focusing (emotions and bodily sensations), the ability to perform focusing and emotion regulation. Secondary outcomes include mental health and psychological well-being, depression and anxiety symptoms and self-esteem., Ethics and Dissemination: Our study has been approved by the Council of Ethics and Deontology of the University of Maia. Findings will be disseminated via manuscripts, presentations and the lead author's thesis., Trial Registration Number: ISRCTN16974329., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Olfactory dysfunction (OD) is a prevalent nasal affliction that has detrimental effects on the patients' quality of life and safety. Conventional therapeutic strategies have various limitations such as high costs, prolonged treatment durations and adverse side effects. Intranasal insulin is a novel intervention for the management of OD. To date, few systematic reviews have been conducted to evaluate the efficacy of this intervention. This study aims to critically assess the therapeutic efficacy and safety profile of intranasal insulin administration in patients with OD., Methods and Analysis: A systematic literature search will be performed on several databases, including PubMed, the Cochrane Central Register of Controlled Trials, Embase, SinoMed and China National Knowledge Infrastructure (CNKI), to identify studies investigating the efficacy of intranasal insulin in treating OD. The search will span from database inception to 1 April 2024, including publication in Chinese and English languages. Data will be retrieved from the literature by two independent investigators. Subsequently, the data will be processed using RevMan V.5.3.5. The meta-analysis will be performed in line with the Cochrane Handbook guidelines. The clinical efficacy and safety of intranasal insulin for OD will be appraised based on various outcomes, including overall symptom improvement, the Connecticut Chemosensory Clinical Research Center score, variations in serum glucose levels, body mass index variations and the incidence of adverse events., Ethics and Dissemination: This will be a systematic review of available literature; thus, no ethical clearance is required. The results of this study will be shared through journal publication or presented at an academic conference., Trial Registration Number: According to the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 16 May 2024 (registration number CRD42024543438)., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Post-intensive care syndrome (PICS) seriously affects the quality of life of intensive care unit (ICU) survivors, their ability to return to work and society and the quality of life of their families, increasing overall care costs and healthcare expenditures. ICU follow-up services have important potential to improve PICS. However, the best clinical practice model of ICU follow-up service has not been fully defined and its benefits for ICU survivors are not clear. This review will synthesise and map the current types of follow-up services for ICU survivors and summarise the impact of follow-up services on PICS., Methods and Analysis: This scoping review will be conducted by applying the five-stage protocol proposed by Arksey and O'Malley in an updated version of the Joanna Briggs Institute. Eight academic databases including the Cochrane Library, MEDLINE, Web of Science, Embase, EBSCO Academic, CINAHL, PsycInfo and SinoMed (China Biology Medicine) will be systematically searched from inception to the present. Peer-reviewed literature and grey literature will be included. Qualitative, quantitative and mixed methods studies will be included. Studies published in English or Chinese will be included. There will be no time restriction. Two reviewers will screen and select the articles independently and if there is any disagreement, the two reviewers will discuss or invite a third reviewer to make decisions together. Descriptive analysis will be used to conduct an overview of the literature. The results will be presented in a descriptive format in response to the review questions accompanied by the necessary tables or charts., Ethics and Dissemination: Ethical approval is not required for this scoping review because data could be obtained by reviewing published primary study results and do not involve human participants. Findings should be disseminated at scientific meetings and published in peer-reviewed journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: To explore the postsurgery lived experiences of patients with colorectal cancer with a permanent ostomy for informing initiatives to improve patient care and future quantitative research., Design: A descriptive qualitative phenomenological study., Setting: We conducted this study in the Colorectal Cancer Division at the Cancer Center of West China Hospital, Sichuan University, a premier institution renowned for its comprehensive cancer care and research., Participants: 12 patients who had undergone surgeries for colorectal cancer with a permanent ostomy., Results: Our interviews revealed profound adjustments in the lives of colorectal cancer survivors living with permanent ostomies. Participants articulated a transition to a 'new normal', characterised by extensive daily life adjustments, psychological adaptation and ongoing management challenges. Key themes identified included the adaptation to a reshaped daily routine and altered perceptions of quality of life. Many faced substantial challenges in stoma care, requiring significant learning and adaptation. Psychological adaptations were marked by a redefinition of body autonomy and personal identity, alongside a recalibration of social interactions and privacy. The need for robust professional guidance and a comprehensive social support system was universally emphasised., Conclusions: Patients with colorectal cancer with permanent ostomies navigate significant changes in their lives postsurgery, undertaking a complex process of reconstructing and adapting to a new normalcy. They recalibrate their physical, psychological and social well-being, demonstrating resilience and adaptability in the face of these challenges. Their pervasive expression of needs for information and support may reflect gaps in the existing patient education and support measures and communication strategies. Healthcare professionals and policy-makers should adopt a patient-centred approach acknowledging the multifaceted nature of postsurgery recovery and adaptation by fostering open communication, tailoring personalised education and facilitating supportive community networks., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Differential target multiplexed spinal cord stimulation (DTM SCS) is a new stimulation paradigm for chronic pain management with the aim of modulating glial cells and neurons in order to rebalance their interactions. Animal studies revealed positive effects of this type of stimulation; however, studies in humans are still scarce, pointing towards the need for an evaluation of the effectiveness and safety of DTM SCS in clinical settings. Furthermore, the differential target multiplexed (DTM) algorithm consists of a combination of several programmes, which will presumably consume more energy from the spinal cord stimulation (SCS) battery. Therefore, the objective of DETECT is to investigate the feasibility, effectiveness and safety of DTM SCS in patients with Persistent Spinal Pain Syndrome Type II through a longitudinal cohort study., Methods and Analysis: DETECT is a prospective multicentre cohort study (n≥250) with a follow-up until 12 months after receiving DTM SCS. The study initiated in October 2021 and is currently still recruiting patients. Self-reporting outcome variables were evaluated at baseline (before SCS) and at 1, 6 and 12 months of DTM SCS. The primary effectiveness endpoint is overall pain intensity, measured with the visual analogue scale. Secondary effectiveness outcome measures are back pain intensity, leg pain intensity, disability, health-related quality of life, pain medication use, functional disability, clinical holistic responder status, self-management, impression of change, work status, pain catastrophising, symptoms of central sensitisation, anxiety, depression and healthcare utilisation. Time spent in different body postures and SCS stimulation parameters will be read out from the pulse generator. The prevalence of technical issues, recharge frequency, (serious) adverse events and the proportion of successful DTM trials will be collected as well. Longitudinal mixed models will be calculated to evaluate the effectiveness of DTM SCS over time., Ethics and Dissemination: The study protocol was approved by the central Ethics Committee of the Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel (B.U.N.1432021000563) and the Ethics Committees of each participating centre. Research findings will be disseminated to key stakeholders through peer-reviewed publications in scientific journals and presentations to clinical audiences., Trial Registration Number: NCT05068011., Competing Interests: Competing interests: The principal investigator (MM) has no financial or competing interests that might influence the design, conduct or reporting of the trial. He has no ownership interest related to the medical device. He has received speaker fees from Medtronic. SE has received consulting fees from Medtronic, Mainstay Medical and Saluda Medical. His department has received research funding from Medtronic, Nevro and Boston Scientific. MB reported grants from Medtronic, Abbott and Boston Scientific. MR reported grants from Medtronic, Abbott and Boston Scientific. PR reports grants from Medtronic, Abbott and Boston Scientific and consultant fees and payments for lectures from Medtronic and Boston Scientific, outside the submitted work. LG is a postdoctoral research fellow funded by the Research Foundation Flanders (FWO), Belgium (project number 12ZF622N). STIMULUS has received independent research grants from Medtronic., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: The relationship between a healthy lifestyle and depression in radiology residents remains poorly understood. This study aims to investigate the relationship between a healthy lifestyle and depressive symptoms in radiology residents in a nationwide survey., Design: Cross-sectional study., Setting: The survey was conducted among radiology residents undergoing training in China between December 2020 and April 2021. This encompassed a total of 215 municipalities and 406 training centres., Participants: 3677 radiology residents in 31 provinces of China., Primary and Secondary Outcome Measures: The primary outcome was Healthy Lifestyle Score (HLS). A multiple logistic regression analysis was performed to evaluate the association between lifestyle factors and depressive symptoms. Additionally, the weighted quantile sum (WQS) index was utilised to identify the lifestyle factor that had the greatest impact on depressive symptoms., Results: The study sample consisted of 3677 participants, among whom the prevalence of depression was 34.7%. Participants were categorised based on their Health Lifestyle Score (HLS) into three groups: low HLS (LHLS), moderate HLS (MHLS) and high HLS (HHLS), with proportions of 8.0%, 79.8% and 12.2%, respectively. Those with LHLS were found to have a significantly higher risk of depression (OR: 5.21, 95% CI: 3.72 to 7.30) and a more severe level of depression (p for trend<0.001) compared with those with HHLS. Furthermore, the Well-being Quality of Life Index (WQS) showed a significant association with depression (OR: 0.34, 95% CI: 0.28 to 0.40), with sleep being identified as the most significant factor contributing to a healthy lifestyle., Conclusion: The study establishes a significant association between an LHLS (long and irregular work hours) and an elevated risk of depressive symptoms among the participants, emphasising the crucial role of sleep in this relationship. These findings underline the importance of promoting a healthy lifestyle, specifically emphasising the need for adequate sleep, among radiology residents., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Post-COVID-19 condition, or syndrome, also known as long COVID, is an infection-associated chronic condition that can develop after a SARS-CoV-2 infection and last at least 3 months to years. Despite representing a high burden for the Unified Health System (SUS), which has affected millions of Brazilians, it has received limited attention in Brazil. Prevalence studies to date have failed to include a broad representation of the population, and there has been insufficient exploration of the impact on people's lives and the burden of and barriers to accessing health services. This article presents the research protocol for the quantitative component of a mixed methods project to produce evidence to inform SUS's provision of care for long COVID. The protocol was designed to study long COVID in SUS patients hospitalised for COVID-19 in a large city in Southeast Brazil to capture symptoms and factors associated with the syndrome, effects on quality of life and employment, health needs, use of health services and barriers to accessing necessary healthcare., Methods and Analysis: An ambidirectional cohort study to capture data retrospectively and prospectively from adults previously discharged from SUS hospitals for COVID-19. The study involves up to two telephone surveys with the patients or proxies selected from a sampling plan for population estimates. Survey questions include baseline and follow-up data on demographic, socioeconomic, comorbidities, work status, health-related quality of life, vaccination status, long COVID symptoms, healthcare needs, use and barriers to access. Descriptive and appropriate multivariable analyses will be employed., Ethics and Dissemination: The project was approved by the Research Ethics Committees of participant institutions and by the Brazilian National Research Ethics Commission. All participants provided verbal consent. We plan to publish articles in scientific journals and multimedia resources for SUS professionals and the general population., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: During 2015-2018, a randomised controlled trial (RCT) evaluated eRAPID, an eHealth intervention designed to capture patient-reported symptoms online during cancer treatment. eRAPID provides patients with advice on when to self-manage or seek medical support. Clinicians accessed symptom reports within electronic patient records. 508 participants starting systemic cancer treatment were recruited and followed for 18 weeks. The intervention group (n=256) was asked to access eRAPID and complete weekly online symptom reports. Clinicians received training on accessing and interpreting symptom reports. Overall, eRAPID had a positive impact on patients' symptoms, quality of life and self-efficacy, particularly early in treatment and for patients with early-stage disease. Using mixed methods, we aimed to gather insight from patients and clinicians on how eRAPID worked to facilitate the interpretation of RCT findings., Methods: Following a concurrent triangulation design, patient experiences of eRAPID were gathered via end-of-study interviews (n=45) and questionnaires (n=186). Clinician experiences were obtained by end-of-study interviews (n=18) and completion, throughout the trial, of feedback questionnaires (n=787 from n=55 clinicians). Framework analysis was applied to examine qualitative data and close-ended questions were descriptively summarised. Findings were mapped against results from the RCT., Setting: Medical oncology services, UK cancer centre., Results: Patient feedback indicated eRAPID was easy to use. Adherence to weekly reporting was influenced by health status, reminders, perceived value and clinical use. Patient-reported benefits of eRAPID included an enhanced connection with the hospital, provision of practical advice and personal monitoring, which provided reassurance and empowerment. Clinicians were positive about the potential for online symptom monitoring but had mixed levels of direct experience with using eRAPID during the trial. Patients echoed this and recommended more explicit clinician use of symptom data., Conclusions: The mixed-method approach to capturing patient and clinician opinions provided valuable insight into the eRAPID intervention and complementary information on how the intervention was received and functioned., Competing Interests: Competing interests: GV has received honoraria from Eisai, Pfizer, Novartis and has provided consulting/advisory roles for Roche UK, Eisai, Novartis, Sanofi, Pfizer, AstraZeneca, Seagen. JB has received institutional funding from National Institute for Health and Care Research, Roche, European Union, Janssen, AbbVie, Pierre Fabre. We declare no other competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: Evidence suggests that sedentary behaviour (SB) and physical activity (PA) are important indicators of well-being and quality of life in older adults (OAs). However, OAs are the least active and highly sedentary of all the age groups. The present study intends to examine the feasibility of a wearable gadget to remind users to break sitting time (by standing up and moving more), coupled with a brief health coaching session, pamphlet and reminder messages to decrease SB and improve PA., Methods and Analysis: This study will employ a multi-methods approach that generates quantitative data from questionnaires and qualitative data from semi-structured interviews following OAs' involvement in the study. This intervention will be informed by the socio-ecological model (SEM) and the habit formation model. The quantitative and qualitative data will be analysed separately and then integrated for interpretation and reporting, which will assist our knowledge of the feasibility of the programme., Ethics and Dissemination: Ethical approval for this study has been obtained from Swansea University (NM&#95; 2023 6667 6123). Informed consent will be obtained from participants. The findings of the study will be disseminated to the scientific community through conference presentations and scientific publications. The findings of the current study will determine the suitability of a future effectiveness trial., Trial Registration Number: NCT06407557., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Introduction: This study aims to evaluate the efficacy of a computer vision system in guiding exercise management for patients with knee osteoarthritis (OA) by comparing functional improvement between a tele-rehabilitation versus an outpatient intervention program., Methods and Analysis: This is a prospective, single-blind, randomised controlled trial of 60 patients with knee OA who will be randomly assigned to exercise therapy (n=30) or control (n=30) . Both groups will receive treatment two times per week for 12 weeks. The primary outcome of the study will be assessed using the University of Western Ontario and McMaster University Osteoarthritis Index (WOMAC). The Knee Injury and Osteoarthritis Outcome Score will be assessed, as well as the visual analogue scale, quality of life score and physical fitness score. All observations will be collected at baseline and at weeks 4, 8 and 12 during the intervention period, as well as at weeks 4, 8, 12 and 24 during the follow-up visits after the end of the intervention., Ethics and Dissemination: This evaluator-blinded, prospective, randomised controlled study was approved by the Biomedical Ethics Review Committee of West China Hospital of Sichuan University., Trial Registration Number: ChiCTR2300070319., Competing Interests: Competing interests: Di Liu is the employee of Jiakang Zhongzhi Technology Company. The remaining authors declare that they have no conflicts of interest., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Cancer-related insomnia (CRI), a significant concurrent symptom of cancer, profoundly impacts patients. Non-pharmacological interventions include cognitive behavioural therapy, mindfulness-based stress reduction programmes, bright light, acupuncture, exercise and music therapies and tai chi. These approaches, unlike pharmacological treatments, exhibit minimal adverse effects, without drug-drug interactions. They are a promising treatment strategy for CRI patients. However, a comprehensive comparative study evaluating the efficacy and safety of all non-pharmacological interventions for CRI is lacking. Accordingly, we aim to conduct a relatively comprehensive systematic review and network meta-analysis., Methods and Analysis: We will conduct an extensive search across various databases, including Pubmed, Web of Science, Cochrane Library, Embase, Google Scholar, China National Knowledge Infrastructure (CNKI), China Biomedical Literature Database (CBM), Wanfang and Vip databases (VIP). The search will focus on non-pharmacological therapeutic interventions related to CRI in randomised controlled trials published from the inception of these databases until 15 May 2024. The primary outcomes of this study will encompass the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI), while the secondary outcomes will evaluate sleep parameters, fatigue levels, anxiety-depressive mood, quality of life and any potential adverse effects. Paired meta-analyses and network meta-analyses will be conducted utilising ADDIS V.1.16.8, Stata V.14.2 and V.R4.1.2. Bias risk will be independently assessed using the Cochrane Risk of Bias tool (ROB V.2.0), and the evidence quality will be evaluated according to Grading of Recommendations Assessment, Development, and Evaluation (GRADE) standards., Ethics and Dissemination: There are no ethical issues as this study did not conduct any experiments, surveys, or human trials. We will ensure that the findings are shared through pertinent channels., Prospero Registration Number: CRD42023427752., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Introduction: Preoperative inspiratory muscle training (IMT) is recognised as an important component of the preoperative management of lung cancer, although there is limited evidence for the delivery of a home-based IMT programme combined with preoperative education. We developed a programme combining short-term home-based IMT and preoperative physiotherapy education ('the programme'). This study aims to evaluate the effectiveness of this programme in reducing postoperative pulmonary complications (PPCs) after lung cancer resection compared with standard care., Methods and Analysis: In this randomised controlled trial, 114 participants scheduled for lung cancer surgery at the First Affiliated Hospital of Fujian Medical University will be randomly assigned (1:1) to either receive usual care (information booklet) or usual care combined with the programme, which consist of short-term home-based IMT and preoperative physiotherapy education. The primary outcome measure will be PPCs using the Melbourne Group Score. Secondary outcomes will include health-related quality of life, maximal inspiratory pressure, 6 min walk distance, length of hospital stay, anxiety and depression levels, and hospital costs., Ethics and Dissemination: The study has received ethics approval from the ethics committee of the first affiliated hospital of Fujian Medical University (approval no: MRCTA, ECFAH of MFU [2021]569). Participants will be required to provide written informed consent. The results of the study will be submitted for publication in peer-reviewed journals., Trial Registration Number: ChiCTR2300067464., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)