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☐ ☆ ✇ BMJ Open

Nebulised furosemide for the treatment of patients with obstructive lung disease: a systematic review protocol

Por: Veldhoen · R. · Muscedere · J. — Noviembre 23rd 2023 at 17:23
Introduction

Obstructive lung diseases (OLDs) such as asthma and chronic obstructive pulmonary disease are major global sources of morbidity and mortality. Current treatments broadly include bronchodilators such as beta agonists/antimuscarinics and anti-inflammatory agents such as steroids. Despite therapy patients still experience exacerbations of their diseases and overall decline over time. Nebulised furosemide may have a novel use in the treatment of OLD. Multiple small studies have shown improvement in pulmonary function as well as dyspnoea. This systematic review will aim to summarise and analyse the existing literature on nebulised furosemide use in OLD to guide treatment and future studies.

Methods and analysis

We will identify all experimental studies using nebulised/inhaled furosemide in patients with asthma or chronic obstructive pulmonary disease that report any outcome. Databases will include EMBASE, MEDLINE, Cochrane Database of Systematic Reviews, ACP Journal Club, Database of Abstracts of Reviews of Effects, Cochrane Clinical Answers, Cochrane Central Register of Controlled Trials, Cochrane Methodology Register, Health Technology Assessment and the NHS Economic Evaluation Database (1995–2015). We will also search ClinicalTrials.gov and the WHO-International Clinical Trials Registry Platform. Two reviewers will independently determine trial eligibility. For each included trial, we will perform duplicate independent data extraction, risk of bias assessment and evaluation of the quality of evidence using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

Ethics and dissemination

Ethical approval will not be applicable to this systematic review. The results of the study will be communicated through publication in peer-reviewed journals.

PROSPERO registration number

CRD42021284680.

☐ ☆ ✇ BMJ Open

Factors associated with continuation of hormonal contraceptives among married women of reproductive age in Gilgit, Pakistan: a community-based case-control study

Por: Bibi · F. · Saleem · S. · Tikmani · S. S. · Rozi · S. — Noviembre 23rd 2023 at 17:23
Objective

This study aimed to determine the factors associated with continuation of hormonal contraceptive methods among married women of Gilgit, Pakistan at least 6 months after their initiation.

Design

Unmatched case–control study.

Setting

Community settings of Gilgit, Pakistan from 1 April 2021 to 30 July 2021.

Participants

The cases were married women of reproductive age who, at the time of interview, were using a hormonal method of contraception for at least 6 months continuously, and controls were married women of reproductive age who had used a hormonal method in the past and currently were using a non-hormonal method for at least 6 months.

Primary and secondary outcome measures

OR for continuation of hormonal contraceptive.

Results

The factors significantly associated with continuous use of hormonal contraceptive methods for our sample from Gilgit were the family planning centre’s distance from home (adjusted OR (AOR) 6.33, 95% CI 3.74 to 10.71), satisfaction with current method used (AOR 3.64, 95% CI 2.06 to 6.44), visits to the family planning centre to avail services (AOR 1.86, 95% CI 1.07 to 3.45) and relatively older age of women (AOR 1.07, 95% CI 1.02 to 1.12). In addition, women with formal education (AOR 0.27, 95% CI 0.12 to 0.6) were less likely to use a modern contraceptive method.

Conclusion

Continuation of using a hormonal method was associated with easy access to family planning centres, satisfaction with the current method and frequent visits to the family planning centres. Continuation of using a hormonal method was also seen in women with low education status. The importance of the presence of family planning centres near residential areas cannot be emphasised more. This does not only provide easy access to family planning methods, but also reassure women of continuation of modern methods when they face any unpleasant effects while using these.

☐ ☆ ✇ BMJ Open

Prevalence of psychological distress and associated factors among patients undergoing comprehensive genomic profiling testing: protocol for a multicentre, prospective, observational study

Por: Matsuoka · A. · Fujimori · M. · Koyama · T. · Sato · A. · Mori · K. · Hirata · M. · Tanabe · N. · Nakachi · K. · Kato · S. · Okamoto · H. · Ogawa · K. · Komatsu · H. · Iwasaku · M. · Miyaji · T. · Uchitomi · Y. — Noviembre 23rd 2023 at 17:23
Introduction

Since May 2019, comprehensive genomic profiling (CGP) has been covered by Japan’s health insurance system for patients with solid tumours that have progressed on standard chemotherapy, rare tumours or tumours of unknown primary origin. Although CGP has the potential to identify actionable mutations that can guide the selection of genomically matched therapies for patients with advanced cancer and limited treatment options, less than 10% of patients benefit from CGP testing, which may have a negative impact on patients’ mental status. The aim of this study is to investigate the prevalence of psychological distress and associated factors among patients with advanced cancer who are undergoing CGP testing across Japan.

Methods and analysis

This multicentre, prospective cohort study will enrol a total of 700 patients with advanced cancer undergoing CGP testing. Participants will be asked to complete questionnaires at three timepoints: at the time of consenting to CGP testing (T1), at the time of receiving the CGP results (T2; 2–3 months after T1) and 4–5 months after T2 (T3). Primary outcome is the prevalence of depression as measured by the Patient Health Questionnaire-9 at the three timepoints. Secondary outcomes are the prevalence of anxiety and Quality of Life Score. Associated factors with psychological distress will also be examined, including knowledge about CGP, attitudes, values and preferences towards CGP, satisfaction with oncologists’ communication and patient characteristics as well as medical information including CGP test results and genomically matched therapies if provided. The prevalence of depression and anxiety will be estimated using the unadjusted raw rates observed in the total sample. Longitudinal changes in measures will be explored by calculating differences between the timepoints. Multivariate associations between variables will be examined using multiple or logistic regression analysis depending on the outcomes to adjust for confounders and to identify outcome predictors.

Ethics and dissemination

This study was approved by the Institutional Review Board of the National Cancer Center Japan on 5 January 2023 (ID: 2022-228). Study findings will be disseminated through peer-reviewed journals and conference presentations.

Trial status

The study is currently recruiting participants and the enrolment period will end on 31 March 2025, with an expected follow-up date of 31 March 2026.

Trial registration number

UMIN000049964.

☐ ☆ ✇ BMJ Open

Factors associated with uptake of human papillomavirus vaccination among adolescent girls in Mettu town, southwest Ethiopia: a school-based cross-sectional study

Por: Dawud · A. · Kera · A. M. · Bekele · D. · Hiko · D. · Zewdie · A. — Noviembre 23rd 2023 at 17:23
Objective

This study was designed to assess the level of uptake of human papillomavirus (HPV) vaccination and its associated factors among school-age adolescent girls.

Design

School-based cross-sectional study.

Setting

High schools in Mettu town, southwest Ethiopia, from 5 February to 10 March 2022.

Participants

Data were collected using a pretested and structured questionnaire through face-to-face interviews with 667 adolescent girls selected via multistage random sampling. Data were entered into EpiData V.3.1 and exported to SPSS V.26 for analysis. Simple binary logistic regression was done, and variables with a p value less than 0.25 were entered into a multivariable logistic regression model; variables with a p value

Results

About half (48.6%) of adolescent girls aged 14–18 years had received the HPV vaccine. Being in the 16–18 years age group (adjusted OR 2.7, 95% CI 1.50 to 4.80), having good knowledge (2.14, 95% CI 1.29 to 3.52), having a positive attitude (5.86, 95% CI 3.51 to 9.76), and getting encouragement from healthcare workers (3.04, 95% CI 1.36 to 6.79), teachers (2.14, 95% CI 1.05 to 4.34) and parents (2.39, 95% CI 1.02 to 5.64) were significantly associated with vaccine uptake.

Conclusion

The uptake of HPV vaccination was low. Having good knowledge and positive attitude as well as encouragement from parents, healthcare workers and teachers were identified as factors associated with HPV vaccine uptake. Improving knowledge about HPV and involving teachers and parents in the immunisation campaign might help promote HPV vaccine uptake.

☐ ☆ ✇ BMJ Open

Prevention of psychosocial distress consequences in somatic hospital inpatients via a stepped and collaborative care model: protocol of SomPsyNet, a stepped wedge cluster randomised trial

Por: Meinlschmidt · G. · Frick · A. · Baenteli · I. · Karpf · C. · Studer · A. · Bachmann · M. · Dörner · A. · Tschudin · S. · Trost · S. · Wyss · K. · Fink · G. · Schwenkglenks · M. · Caviezel · S. · Rocco · T. · Schaefert · R. · The SomPsyNet consortium · Aebi · Bachmann · Caviezel · Baen — Noviembre 23rd 2023 at 17:23
Introduction

Approximately 30% of somatic hospital inpatients experience psychosocial distress, contributing to increased (re-)hospitalisation rates, treatment resistance, morbidity, and direct and indirect costs. However, such distress often remains unrecognised and unaddressed. We established ‘SomPsyNet’, a ‘stepped and collaborative care model’ (SCCM) for somatic hospital inpatients, aiming at alleviating this issue through early identification of distress and provision of appropriate care, providing problem-focused pathways and strengthening collaborative care. We report the protocol of the ‘SomPsyNet’ study, aiming to evaluate implementation and impact of the SCCM on distressed patients’ health-related quality of life. Secondary objectives include assessing efficacy of the screening procedures, influence of SCCM on other health outcomes and associated costs.

Methods and analysis

Our stepped wedge cluster randomised trial conducted at three tertiary hospitals comprises three conditions: treatment as usual (TAU) without screening for distress (phase 0), TAU with screening but without consequences (phase I, main comparator) and TAU with screening and psychosomatic-psychiatric consultations for those distressed (phase II). The time-of-transition between phases I and II was randomised. Sample size target is N=2200–2500 participants, with 6 month follow-up for distressed (anticipated n=640–700) and a subsample of non-distressed (anticipated n=200) patients. Primary outcome is mental health-related quality of life (SF-36 ‘Mental Health Component Summary score’); secondary outcomes include psychosocial distress, anxiety, depressive and somatic symptoms, symptom burden and distress, resilience, social support and qualitative of life, assessed by internationally accepted instruments, with good psychometric properties. Further, health claims data will be used to assess SCCM’s impact on direct and indirect costs.

Ethics and dissemination

SomPsyNet adheres to the Helsinki Declaration and is approved by the ‘Ethikkommission Nordwest- und Zentralschweiz’ (2019–01724). Findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public.

Trial registration number

Swiss National Clinical Trials Portal; ClinicalTrials.gov (NCT04269005, updated 19.09.2023).

☐ ☆ ✇ BMJ Open

Do community-based singing interventions have an impact on people living with dementia and their carers? A mixed-methods study protocol

Por: Polden · M. · Hanna · K. · Ward · K. · Ahmed · F. · Brown · H. · Holland · C. · Barrow · H. · Main · J. · Mann · S. · Pendrill · S. · Giebel · C. — Noviembre 23rd 2023 at 17:23
Introduction

Psychosocial interventions have been shown to improve mood, relieve stress and improve quality of life for people living with dementia (PwD). To date, most evaluations of singing interventions have focused on the benefits for PwD and not their carers. This research aims to evaluate the benefits of dementia singing groups for both PwD and their carers.

Methods and analysis

This 2-year project will observe the impact of two different singing intervention services, one combining singing alongside dance and another that includes a sociable lunch. This project will aim to recruit a total of n=150 PwD and n=150 carers across the two singing interventions. Using a mixed-methods approach, the influence of both services will be analysed via the following outcome measures: quality of life, neuropsychiatric symptoms, social isolation, loneliness, cognition, carer burden and depressive symptoms in PwD and their carers using a prestudy/poststudy design. Regression models will be used to analyse the data with time (pre/post) as the exposure variable. Semistructured interviews will be conducted with a subset of people (n=40) to further investigate the impact of singing services with a specific focus on the acceptability of the interventions, barriers to access and prolonged engagement and potential for remote delivery. Interview data will be analysed using Braun and Clarke’s reflexive thematic analysis, and public advisers will assist with coding the transcripts. A social return on investment analysis will be conducted to determine the social impact of the services.

Ethics and dissemination

This project has received ethical approval from the University of Liverpool’s Ethics Committee (App ref: 12374) and Lancaster University’s Ethics Committee (App ref: 3442). All participants will provide informed consent to participate. Results will be presented at national and international conferences, published in scientific journals and publicly disseminated to key stakeholders.

☐ ☆ ✇ BMJ Open

Prognostic significance of platelet-to-lymphocyte ratio (PLR) in patients with breast cancer treated with neoadjuvant chemotherapy: a meta-analysis

Por: Qi · X. · Chen · J. · Wei · S. · Ni · J. · Song · L. · Jin · C. · Yang · L. · Zhang · X. — Noviembre 23rd 2023 at 17:23
Objective

Platelet-to-lymphocyte ratio (PLR), known as a key systemic inflammatory parameter, has been proved to be associated with response to neoadjuvant therapy in breast cancer (BC); however, the results remain controversial. This meta-analysis was carried out to evaluate the prognostic values of PLR in patients with BC treated with neoadjuvant chemotherapy (NACT).

Design

Meta-analysis.

Data sources

Relevant literature published on the following databases: PubMed, Embase, Web of Science databases and the Cochrane Library.

Eligibility criteria

All studies involving patients with BC treated with NACT and peripheral blood pretreatment PLR recorded were included.

Data extraction and synthesis

Two researchers independently extracted and evaluated HR/OR and its 95% CI of survival outcomes, pathological complete response (pCR) rate and clinicopathological parameters.

Results

The last search was updated to 31 December 2022. A total of 22 studies with 5533 patients with BC treated with NACT were enrolled in the final meta-analysis. Our results demonstrate that elevated PLR value appears to correlate with low pCR rate (HR 0.77, 95% CI 0.67 to 0.88, p2=75.80%, Ph2=7.40%, Ph=0.365) and disease-free survival (HR 1.97, 95% CI 1.56 to 2.50, p2=0.0%, Ph=0.460). Furthermore, PLR level was associated with age (OR 0.86, 95% CI 0.79 to 0.93, p2=40.60%, Ph=0.096), menopausal status (OR 0.83, 95% CI 0.76 to 0.90, p2=50.80%, Ph=0.087) and T stage (OR 1.05, 95% CI 1.00 to 1.11, p=0.035; I2=70.30%, Ph=0.005) of patients with BC.

Conclusions

This meta-analysis demonstrated that high PLR was significantly related to the low pCR rate, poor OS and disease-free survival (DFS) of patients with BC treated with NACT. Therefore, PLR can be used as a potential predictor biomarker for the efficacy of NACT in BC.

☐ ☆ ✇ BMJ Open

Accelerometer derived physical activity and subclinical coronary and carotid atherosclerosis: cross-sectional analyses in 22 703 middle-aged men and women in the SCAPIS study

Por: Ekblom-Bak · E. · Börjesson · M. · Ekblom · O. · Angeras · O. · Bergman · F. · Berntsson · C. · Carlhäll · C.-J. · Engström · G. · Engvall · J. · Fagman · E. · Flinck · A. · Johansson · P. · Jujic · A. · Kero · T. · Lind · L. · Mannila · M. · Ostenfeld · E. · Persson · A. · Persson — Noviembre 23rd 2023 at 17:23
Objectives

The aim included investigation of the associations between sedentary (SED), low-intensity physical activity (LIPA), moderate-to-vigorous intensity PA (MVPA) and the prevalence of subclinical atherosclerosis in both coronaries and carotids and the estimated difference in prevalence by theoretical reallocation of time in different PA behaviours.

Design

Cross-sectional.

Setting

Multisite study at university hospitals.

Participants

A total of 22 670 participants without cardiovascular disease (51% women, 57.4 years, SD 4.3) from the population-based Swedish CArdioPulmonary bioImage study were included. SED, LIPA and MVPA were assessed by hip-worn accelerometer.

Primary and secondary outcomes

Any and significant subclinical coronary atherosclerosis (CA), Coronary Artery Calcium Score (CACS) and carotid atherosclerosis (CarA) were derived from imaging data from coronary CT angiography and carotid ultrasound.

Results

High daily SED (>70% 10.5 hours/day) associated with a higher OR 1.44 (95% CI 1.09 to 1.91), for significant CA, and with lower OR 0.77 (95% CI 0.63 to 0.95), for significant CarA. High LIPA (>55% 8 hours/day) associated with lower OR for significant CA 0.70 (95% CI 0.51 to 0.96), and CACS, 0.71 (95% CI 0.51 to 0.97), but with higher OR for CarA 1.41 (95% CI 1.12 to 1.76). MVPA above reference level, >2% 20 min/day, associated with lower OR for significant CA (OR range 0.61–0.67), CACS (OR range 0.71–0.75) and CarA (OR range 0.72–0.79). Theoretical replacement of 30 min of SED into an equal amount of MVPA associated with lower OR for significant CA, especially in participants with high SED 0.84 (95% CI 0.76 to 0.96) or low MVPA 0.51 (0.36 to 0.73).

Conclusions

MVPA was associated with a lower risk for significant atherosclerosis in both coronaries and carotids, while the association varied in strength and direction for SED and LIPA, respectively. If causal, clinical implications include avoiding high levels of daily SED and low levels of MVPA to reduce the risk of developing significant subclinical atherosclerosis.

☐ ☆ ✇ BMJ Open

Effectiveness of an online management platform (Joint Cloud) versus standard process for patients undergoing total knee arthroplasty: study protocol for a prospective randomised controlled trial

Por: Zhang · S. · Ma · H. · Wang · L. · Wang · M. · Li · B. · Liu · J. — Noviembre 23rd 2023 at 17:23
Introduction

Osteoarthritis (OA) is one of the main causes of mobility impairment in the elderly worldwide. Therefore, total knee arthroplasty (TKA) is often performed and is one of the most successful surgery and has resulted in substantial quality-of-life gains for people with end-stage arthritis. There is still room for improvement in the standard treatment process in the preoperative, intraoperative and postoperative period of TKA. Telerehabilitation has the potential to become a positive alternative to face-to-face rehabilitation nowadays. But it remains unclear how well telemedicine interventions cover the entire surgical pathway (preoperation, intraoperation, postoperation). This study aims to explore the effectiveness of Joint Cloud (JC, an online management platform) compared with existing standard process in regulating functional recovery, pain management, muscle strength changes and other health-related outcomes in patients undergoing total knee arthroplasty preoperation, intraoperation and postoperation.

Methods and analysis

A randomised controlled trial was designed to compare the online management platform (JC) with standard process (SP) in patients undergoing TKA. A total of 186 TKA patients will be randomly assigned to the intervention (n=93) or control (n=93) group. Patients in the intervention group will receive access to the ‘JC’ mini-program. This mini-program provides popular science information (eg, information about OA and TKA), functional exercise information and communication channels. Patients evaluate their condition and functional level through standardised digital questionnaires. The control group of patients will not accept any functions of this mini-program. The primary outcome is knee functional recovery, and the secondary outcomes are pain management, isometric knee extensor muscle strength, patient satisfaction and cost-benefit analysis. Assessments will be performed 1 month and 3 days before surgery (T0) and 1 month and 3 months after surgery. Data analysis will be performed according to the intent-to-treat (ITT) principle. Repeated measures of linear mixed models and parametric and non-parametric testing will be used for statistical analysis.

Ethics and dissemination

The study was reviewed and approved by the Tianjin Hospital Medical Ethics Review Committee on 10 February 2023 (2022YLS155). Test data are considered highly sensitive but are available upon request. The findings will be disseminated in peer-reviewed publications.

Trial registration number

ChiCTR2300068486.

☐ ☆ ✇ BMJ Open

Multicentre, national, investigator-initiated, randomised, parallel-group, register-based superiority trial to compare extended ECG monitoring versus standard ECG monitoring in elderly patients with ischaemic stroke or transient ischaemic attack and the e

Por: Engdahl · J. · Straat · K. · Isaksson · E. · Rooth · E. · Svennberg · E. · Norrving · B. · Euler · M. v. · Hellqvist · K. · Gu · W. · Ström · J. O. · Själander · S. · Eriksson · M. · Asberg · S. · Wester · P. — Noviembre 23rd 2023 at 17:23
Introduction

Atrial fibrillation (AF) is a major risk factor for ischaemic stroke and transient ischaemic attack (TIA), and AF detection can be challenged by asymptomatic and paroxysmal presentation. Long-term ECG monitoring after ischaemic stroke or TIA is recommended by all major societies in cardiology and cerebrovascular medicine as a secondary prophylactic measure. However, data on stroke reduction are lacking, and the recommendations show significant diversity.

Methods and analysis

AF SPICE is a multicentre, national, investigator-initiated, randomised, parallel-group, register-based trial comparing extended ECG monitoring versus standard ECG monitoring in patients admitted with ischaemic stroke or TIA, with a composite endpoint of stroke, all-cause-mortality and intracerebral bleeding. Patients aged ≥70 years without previous AF will be randomised 1:1 to control (standard ECG monitoring) or intervention (extended ECG monitoring). In the control arm, patients will undergo 48±24 hours (ie, a range of 24–72 hours) of continuous ECG monitoring according to national recommendations. In the intervention arm, patients will undergo 14+14 days of continuous ECG monitoring 3 months apart using an ECG patch device, which will provide an easy-accessed, well-tolerated 14-day continuous ECG recording. All ECG patch recordings will be read in a core facility. In cases of AF detection, oral anticoagulation will be recommended if not contraindicated. A pilot phase has been concluded in 2022, which will transcend into the main trial during 2023–2026, including approximately 30 stroke units. The sample size was calculated to be 3262 patients. The primary outcome will be collected from register data during a 36-month follow-up.

Ethics and dissemination

Ethical approval has been provided by the Swedish Ethical Review Authority, reference 2021–02770. The trial will be conducted according to the ethical principles of the Declaration of Helsinki and national regulatory standards. Positive results from the study have the potential for rapid dissemination in clinical practice.

Trial registration number

NCT05134454.

☐ ☆ ✇ BMJ Open

'Thats how we got around it: a qualitative exploration of healthcare professionals experiences of care provision for asylum applicants with limited English proficiency in UK contingency accommodation

Por: Tomkow · L. · Prager · G. · Drinkwater · J. · Morris · R. L. · Farrington · R. — Noviembre 23rd 2023 at 17:23
Objectives

The inadequate provision of language interpretation for people with limited English proficiency (LEP) is a determinant of poor health, yet interpreters are underused. This research explores the experiences of National Health Service (NHS) staff providing primary care for people seeking asylum, housed in contingency accommodation during COVID-19. This group often have LEP and face multiple additional barriers to healthcare access. Language discrimination is used as a theoretical framework. The potential utility of this concept is explored as a way of understanding and addressing inequities in care.

Design

Qualitative research using semistructured interviews and inductive thematic analysis.

Setting

An NHS primary care service for people seeking asylum based in contingency accommodation during COVID-19 housing superdiverse residents speaking a wide spectrum of languages.

Participants

Ten staff including doctors, nurses, mental health practitioners, healthcare assistants and students participated in semistructured online interviews. Some staff were redeployed to this work due to the pandemic.

Results

All interviewees described patients’ LEP as significant. Inadequate provision of interpretation services impacted the staff’s ability to provide care and compromised patient safety. Discrimination, such as that based on migration status, was recognised and challenged by staff. However, inequity based on language was not articulated as discrimination. Instead, insufficient and substandard interpretation was accepted as the status quo and workarounds used, such as gesticulating or translation phone apps. The theoretical lens of language discrimination shows how this propagates existing social hierarchies and further disadvantages those with LEP.

Conclusions

This research provides empirical evidence of how the inadequate provision of interpreters forces the hand of healthcare staff to use shortcuts. Although this innovative ‘tinkering’ allows staff to get the job done, it risks normalising structural gaps in care provision for people with LEP. Policy-makers must rethink their approach to interpretation provision which prioritises costs over quality. We assert that the concept of language discrimination is a valuable framework for clinicians to better identify and articulate unfair treatment on the grounds of LEP.

☐ ☆ ✇ BMJ Open

Continuation of education after marriage and its associated factors among young adult women: findings from the Bangladesh Demographic and Health Survey 2017-2018

Por: Howlader · S. · Rahman · M. A. · Rahman · M. M. — Noviembre 23rd 2023 at 17:23
Objective

To identify the individual and community-level variables associated with the continuation of education among currently married young adult women in Bangladesh.

Design

Cross-sectional data extracted from the Bangladesh Demographic and Health Survey (BDHS), 2017–2018. The BDHS is a stratified cluster sample of households conducted in two and three stages in both rural and urban settings. A multilevel multinomial logistic regression analysis was employed to identify the associated factors.

Setting

Bangladesh.

Participants

Currently married young adult women aged 15–29 years (n=4595).

Primary outcome

Continuation of education after marriage was measured in the BDHS by asking respondents, ‘Did you continue your studies after marriage?’ with the response options: no; yes, less than a year; yes, for 1–2 years; yes, for 3–4 years; and yes, for 5+ years.

Results

Among young adult women, 28.2% continued education after marriage for different durations of years (

Conclusions

The proportion of women continuing their education after marriage in this sample is low. This study provides insight into the individual-level and community-level barriers women encounter in continuing their education after marriage. The identification of these barriers helps policy-makers develop effective intervention programmes to promote women’s educational attainment.

☐ ☆ ✇ BMJ Open

Clinical validation of the 'C-arm rotational view (CARV): study protocol of a prospective randomised controlled trial

Por: Bleeker · N. J. · Doornberg · J. N. · ten Duis · K. · El Moumni · M. · Jaarsma · R. L. · IJpma · F. F. A. — Noviembre 22nd 2023 at 17:12
Introduction

Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined ‘C-arm rotational view (CARV)’ in order to reduce the risk of rotational malalignment during intramedullary nailing of tibial shaft fractures. The CARV includes predefined fluoroscopy landmark views of the uninjured side to obtain correct alignment of the injured side with use of the rotation of the C-arm.

Methods and analysis

This randomised controlled trial will be conducted in a level 1 trauma centre. Adult patients with an open or closed tibial fracture, eligible for intramedullary nailing, will be enrolled in the study. The interventional group will undergo intramedullary nailing guided by the CARV protocol to obtain accurate alignment. The control group is treated according to current clinical practice, in which alignment control of the tibia is based on clinical estimation of the treating surgeon. The primary endpoint is defined as the degree of rotation measured on low-dose postoperative CT scans.

Ethics and dissemination

The study protocol will be performed in line with local ethical guidelines and the Declaration of Helsinki. The results of this trial will be disseminated in a peer-reviewed manuscript. Future patients are likely to benefit from this trial as it aims to provide a clinically feasible and easy-to-use standardised fluoroscopy protocol to reduce the risk for rotational malalignment during intramedullary nailing of tibial shaft fractures.

Trial registration number

NCT05459038.

☐ ☆ ✇ BMJ Open

Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study

Por: Hirata · T. · Kawaguchi · T. · Azuma · K. · Torii · A. · Usui · H. · Kim · S. · Hayama · T. · Hirate · D. · Kawahara · Y. · Kumihashi · Y. · Chisaka · T. · Wako · T. · Yoshimura · A. · Miyaji · T. · Yamaguchi · T. — Noviembre 22nd 2023 at 17:12
Introduction

The use of immune checkpoint inhibitors (ICIs) is rapidly expanding in cancer treatment. ICIs have a unique safety profile, characterised by immune-related adverse events (irAEs). The safety profile of ICIs lacks patient experience and perspectives. This study primarily aims to obtain a database for descriptive research on the status of irAEs using the Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) in patients with gastrointestinal cancer, lung cancer and malignant pleural mesothelioma treated with regimens containing ICIs.

Methods and analysis

This is an ongoing, multicentre, observational study in Japan. Eligible patients must be at least 20 years old and have been diagnosed with lung cancer, malignant pleural mesothelioma or gastrointestinal cancer and plan to use ICIs. Participants will install the electronic PRO (ePRO) application and report adverse events via ePRO using PRO-CTCAE once weekly for up to 48 weeks. A registry will be established using background information obtained from medical records. The sample size is determined by 1 year projection without using statistical methods. Statistical analyses will include point estimates and 95% CIs for the incidence of each adverse event by cancer type and regimen at each time point.

Ethics and dissemination

This research will be conducted per the Declaration of Helsinki, the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare, and the revised Personal Information Protection Law. The study protocol was approved by the Ethics Committee (approval ID T2021-0180) of Tokyo Medical University Hospital on 15 October 2021.

Registration details

The study began enrolling patients in December 2021. The target enrolment is 260; as of October 2022, 141 have been enrolled, and the enrolment is scheduled to end on 30 June 2023.

Trial registration number

UMIN000046418

☐ ☆ ✇ BMJ Open

Feasibility interventional study investigating PAIN in neurorehabilitation through wearabLE SensorS (PAINLESS): a study protocol

Por: Moscato · S. · Orlandi · S. · Di Gregorio · F. · Lullini · G. · Pozzi · S. · Sabattini · L. · Chiari · L. · La Porta · F. — Noviembre 22nd 2023 at 17:12
Introduction

Millions of people survive injuries to the central or peripheral nervous system for which neurorehabilitation is required. In addition to the physical and cognitive impairments, many neurorehabilitation patients experience pain, often not widely recognised and inadequately treated. This is particularly true for multiple sclerosis (MS) patients, for whom pain is one of the most common symptoms. In clinical practice, pain assessment is usually conducted based on a subjective estimate. This approach can lead to inaccurate evaluations due to the influence of numerous factors, including emotional or cognitive aspects. To date, no objective and simple to use clinical methods allow objective quantification of pain and the diagnostic differentiation between the two main types of pain (nociceptive vs neuropathic). Wearable technologies and artificial intelligence (AI) have the potential to bridge this gap by continuously monitoring patients’ health parameters and extracting meaningful information from them. Therefore, we propose to develop a new automatic AI-powered tool to assess pain and its characteristics during neurorehabilitation treatments using physiological signals collected by wearable sensors.

Methods and analysis

We aim to recruit 15 participants suffering from MS undergoing physiotherapy treatment. During the study, participants will wear a wristband for three consecutive days and be monitored before and after their physiotherapy sessions. Measurement of traditionally used pain assessment questionnaires and scales (ie, painDETECT, Doleur Neuropathique 4 Questions, EuroQoL-5-dimension-3-level) and physiological signals (photoplethysmography, electrodermal activity, skin temperature, accelerometer data) will be collected. Relevant parameters from physiological signals will be identified, and AI algorithms will be used to develop automatic classification methods.

Ethics and dissemination

The study has been approved by the local Ethical Committee (285-2022-SPER-AUSLBO). Participants are required to provide written informed consent. The results will be disseminated through contributions to international conferences and scientific journals, and they will also be included in a doctoral dissertation.

Trial registration number

NCT05747040.

☐ ☆ ✇ BMJ Open

Protocol of a randomised trial of teriparatide followed by zoledronic acid to reduce fracture risk in adults with osteogenesis imperfecta

Por: Hald · J. D. · Keerie · C. · Weir · C. J. · Javaid · M. K. · Lam · W. · Osborne · P. · Walsh · J. · Langdahl · B. L. · Ralston · S. H. — Noviembre 22nd 2023 at 17:12
Introduction

Osteogenesis imperfecta (OI) is a rare genetic disease associated with multiple fractures throughout life. It is often treated with osteoporosis medications but their effectiveness at preventing fractures is unknown. The Treatment of Osteogenesis Imperfecta with Parathyroid Hormone and Zoledronic Acid trial will determine if therapy with teriparatide (TPTD) followed by zoledronic acid (ZA) can reduce the risk of clinical fractures in OI.

Methods and analysis

Individuals aged ≥18 years with a clinical diagnosis of OI are eligible to take part. At baseline, participants will undergo a spine X-ray, and have bone mineral density (BMD) measured by dual-energy X-ray absorptiometry (DXA) at the spine and hip. Information on previous fractures and previous bone targeted treatments will be collected. Questionnaires will be completed to assess pain and other aspects of health-related quality of life (HRQoL). Participants will be randomised to receive a 2-year course of TPTD injections 20 µg daily followed by a single intravenous infusion of 5 mg ZA, or to receive standard care, which will exclude the use of bone anabolic drugs. Participants will be followed up annually, have a repeat DXA at 2 years and at the end of study. Spine X-rays will be repeated at the end of study. The duration of follow-up will range between 2 and 8 years. The primary endpoint will be new clinical fractures confirmed by X-ray or other imaging. Secondary endpoints will include participant reported fractures, BMD and changes in pain and HRQoL.

Ethics and dissemination

The study received ethical approval in December 2016. Following completion of the trial, a manuscript will be submitted to a peer-reviewed journal. The results will inform clinical practice by determining if TPTD/ZA can reduce the risk of fractures in OI compared with standard care.

Trial registration number

ISRCTN15313991.

☐ ☆ ✇ BMJ Open

Health system barriers to timely routine measles vaccinations in rural southwest China: a qualitative study on the perspectives of township vaccination professionals and village doctors

Por: Cheng · M. · Lan · T. · Geater · A. · Deng · Q.-Y. · Lin · Y.-D. · Jiang · L.-Y. · Chen · N. · Zhu · M.-T. · Li · Q. · Tang · X.-Y. — Noviembre 22nd 2023 at 17:12
Objectives

A well-functioning health system ensures timely routine measles vaccinations for age-appropriate children, minimising measles risk. However, there is limited knowledge about the impact of the performance of immunisation programmes in health systems on the timeliness of measles vaccination. This study aimed to identify health system barriers to timely routine measles vaccination in rural southwest China, integrating the perspectives of township vaccination professionals and village doctors.

Design, setting and participants

Qualitative study among township vaccination professionals and village doctors in rural Guangxi, southwest China.

Methods

20 focus group discussions (FGDs) at township level and 120 in-depth interviews (IDIs) at village level, based on a four-theme framework. We used convenience sampling to recruit 60 township vaccination professionals and 120 village doctors in 2015. Instruments used were a semistructured questionnaire and interview outlines. We collected township and village-level data focusing on themes of health resources allocation, pattern of vaccination services, management and supervision of vaccination services, and perceptions of vaccination policy. The FGDs and IDIs were audio-recorded and transcribed. Braun and Clarke’s thematic analysis approach was adopted to synthesise findings into meaningful subthemes, narrative text and illustrative quotations.

Results

The health system barriers to timely routine vaccinations were explored across four themes. Barriers in the health resources allocation theme comprised (1) inadequacy of vaccination-related human resources (eg, lack of township vaccination professionals and lack of young village doctors), and (2) incompatible and non-identical information system of vaccination services across regions. Barriers in the pattern of vaccination services theme included inflexible vaccination services models, for example, routine vaccination services being offered monthly on fixed vaccination days, limited numbers of vaccination days per month, vaccination days being set on non-local market days, vaccination days being clustered into a specific period and absence of formal vaccination appointments. Ineffective economic incentive mechanism was identified as a barrier in the management and supervision of vaccination services theme. Low-degree participation of village doctors in routine vaccination services was identified as a barrier in the perceptions of vaccination policy theme.

Conclusions

We encourage policymakers and stakeholders to apply these findings to improve the timeliness of routine vaccination. Barriers to timely routine vaccination include inadequate allocation of vaccination-related resources and inflexible vaccination service delivery models. Financial and non-financial incentives should be used to retain and recruit vaccination professionals and village doctors. Strengthening information systems with unified data standards enables cross-regional data exchange. Optimising immunisation services and rationalising vaccination days could eliminate health system barriers and improve vaccination timeliness in rural China.

☐ ☆ ✇ BMJ Open

Why do some people with stroke not receive the recommended 45 min of occupational therapy and physiotherapy after stroke? A qualitative study using focus groups

Por: Clark · B. · Burridge · J. · Whitall · J. · Turk · R. · Hughes · A.-M. · Truman · J. — Noviembre 22nd 2023 at 17:12
Objectives

To generate qualitative data on the views of Occupational Therapists and Physiotherapists about why people do not receive the Royal College of Physicians’ recommended minimum of 45 minutes (min) of daily therapy after stroke, in order to inform a Delphi study.

Design

Focus group study.

Setting

Stroke services in the South of England.

Participants

A total of nine participants, in two groups, including therapists covering inpatient and Early Supported Discharge (ESD) services with awareness of the 45 min guideline.

Results

Thematic analysis of focus group data identified five factors that influence the amount of therapy a person receives: The Person (with stroke), Individual Therapist, Stroke Multidisciplinary Team, the Organisation and the Guideline. Study findings suggest that the reasons why a person does not receive the therapy recommendation in inpatient and ESD services relate to either the suitability of the guideline for the person with stroke, or the ability of the service to deliver the guideline.

Conclusion

This study provides evidence for possible reasons why some people do not receive a minimum of 45 minutes of therapy, 5 days per week, related to (1) the suitability of the guideline for people with stroke and (2) services’ ability to deliver this amount of intervention. These two factors are related; therapists decide who should receive therapy and how much in the context of (a) resource availability and (b) people’s need and the benefit they will experience. The study findings, combined with the findings from other studies, will be used to initiate a Delphi study, which will establish consensus among therapists regarding the reasons why some people do not receive the guideline amount of therapy.

☐ ☆ ✇ BMJ Open

Stratification of risk for emergent intracranial abnormalities in children with headaches: a Pediatric Emergency Care Applied Research Network (PECARN) study protocol

Por: Tsze · D. S. · Kuppermann · N. · Casper · T. C. · Barney · B. J. · Richer · L. P. · Liberman · D. B. · Okada · P. J. · Morris · C. R. · Myers · S. R. · Soung · J. K. · Mistry · R. D. · Babcock · L. · Spencer · S. P. · Johnson · M. D. · Klein · E. J. · Quayle · K. S. · Steele · D. W. · Cr — Noviembre 22nd 2023 at 17:12
Introduction

Headache is a common chief complaint of children presenting to emergency departments (EDs). Approximately 0.5%–1% will have emergent intracranial abnormalities (EIAs) such as brain tumours or strokes. However, more than one-third undergo emergent neuroimaging in the ED, resulting in a large number of children unnecessarily exposed to radiation. The overuse of neuroimaging in children with headaches in the ED is driven by clinician concern for life-threatening EIAs and lack of clarity regarding which clinical characteristics accurately identify children with EIAs. The study objective is to derive and internally validate a stratification model that accurately identifies the risk of EIA in children with headaches based on clinically sensible and reliable variables.

Methods and analysis

Prospective cohort study of 28 000 children with headaches presenting to any of 18 EDs in the Pediatric Emergency Care Applied Research Network (PECARN). We include children aged 2–17 years with a chief complaint of headache. We exclude children with a clear non-intracranial alternative diagnosis, fever, neuroimaging within previous year, neurological or developmental condition such that patient history or physical examination may be unreliable, Glasgow Coma Scale score

Ethics and dissemination

Ethics approval was obtained for all participating sites from the University of Utah single Institutional Review Board. A waiver of informed consent was granted for collection of ED data. Verbal consent is obtained for follow-up contact. Results will be disseminated through international conferences, peer-reviewed publications, and open-access materials.

☐ ☆ ✇ BMJ Open

Prevalence, correlates and common methods of non-suicidal self-injury in South Asia: a systematic review

Por: Haregu · T. · Chen · Q. · Arafat · S. M. Y. · Cherian · A. · Armstrong · G. — Noviembre 22nd 2023 at 17:12
Introduction

The dynamics of self-harm vary substantially around the world, yet it is severely under-researched outside of a small number of high-income ‘Western’ countries. South Asia is disproportionately impacted by suicide, yet we know less about non-suicidal self-injury (NSSI) in the region.

Objective

To review and summarise evidence on the prevalence, correlates and common methods of NSSI in South Asia.

Methods

We searched Medline, Embase and PsycINFO for the period 1 January 2000 to 31 August 2023, for peer-reviewed observational studies. A total of 11 studies from eight South Asian countries that reported prevalence and/or correlates of NSSI were included in this review. We assessed the quality of the studies using the Study Quality Assessment Tools for Observational Cohort and Cross-Sectional Studies. We used meta-regression to describe the sources of heterogeneity. Abstracted data were summarised using thematic synthesis.

Results

For non-clinical populations, the 12-month prevalence of NSSI ranged from 3.2% to 44.8%, and the lifetime prevalence ranged from 21% to 33%. For clinical populations, the 12-month prevalence of NSSI ranged from 5% to 16.4%, while the lifetime prevalence ranged from 2% to 27%. Male sex, unemployment, financial stress, history of suicidal behaviour and depression were associated with a higher risk of NSSI. Better access to counselling services, higher self-esteem and self-knowledge were associated with a lower risk of NSSI.

Conclusion

The burden of NSSI in South Asia appears to be high in both clinical and non-clinical populations. Further research, especially with general population samples, is needed to build evidence on the epidemiology, context and meaning of NSSI in South Asia to inform the design of context-specific interventions.

PROSPERO registration number

CRD42022342536.

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