Tag: pubmed

BMJ Open. 2021 Sep 2;11(9):e049878. doi: 10.1136/bmjopen-2021-049878.

ABSTRACT

INTRODUCTION: Given the complex causal origins of many non-communicable diseases (NCDs), and the complex landscapes in which policies designed to tackle them are made and unfold, the need for systems thinking and complexity science (STCS) in developing effective policy solutions has been emphasised. While numerous methods informed by STCS have been applied to the policy process in NCD prevention, these applications have not been systematically catalogued. The aim of this scoping review is to identify existing applications of methods informed by STCS to the policy process for NCD prevention, documenting which domains of the policy process they have been applied to.

METHODS AND ANALYSIS: A systematic scoping review methodology will be used.

IDENTIFICATION: We will search Medline, SCOPUS, Embase and Web of Science using search terms combining STCS, NCD prevention and the policy process. All records published in English will be eligible for inclusion, regardless of study design.

SELECTION: We will screen titles and abstracts and extract data according to published guidelines for scoping reviews. In order to determine the quality of the included studies, we will use the approach developed by Dixon-Woods et al, excluding studies identified as fatally flawed, and determining the credibility and contribution of included studies.

SYNTHESIS: We will identify relevant studies, summarising key data from each study and mapping applications of methods informed by STCS to different parts of the policy process. Review findings will provide a useful reference for policy-makers, outlining which domains of the policy process different methods have been applied to.

ETHICS AND DISSEMINATION: Formal ethical approval is not required, as the study does not involve primary data collection. The findings of this study will be disseminated through a peer-reviewed publication, presentations and summaries for key stakeholders.

PMID:34475176 | DOI:10.1136/bmjopen-2021-049878

BMJ Open. 2021 Sep 2;11(9):e049538. doi: 10.1136/bmjopen-2021-049538.

ABSTRACT

OBJECTIVES: To explore the mechanisms of reduction of suicide mortality in Japan (from 25.7 to 16.5 per 100 000 population) between 2009 and 2018, the present study determined the effects of execution amounts of regional suicide prevention programmes (Emergency Fund to Enhance Community-Based Suicide Countermeasure: EFECBSC) on gender-specific trends of suicide mortality by disaggregated methods.

DESIGN AND SETTING: Stepwise multiple regression analysis was used to determine the effects of execution amounts of 10 subdivisions of execution amounts of financial support for regional suicide prevention programmes (EFECBSC) on suicide methods and gender disaggregated suicide mortalities in Japan between 2009 and 2018 using the statistical data obtained from national governmental database.

RESULTS: The suicide mortalities by the most common/frequent suicide methods, hanging, charcoal burning and jumping were significantly decreased between 2009 and 2018. Male hanging suicide was decreased by prefectural enlightenment, municipal development programmes, but female hanging suicide was decreased by municipal personal consultation programmes. Municipal development and enlightenment programmes decreased male and female charcoal-burning suicide mortalities, respectively. Jumping suicide was decreased by prefectural telephone consultation programmes but was unexpectedly increased by municipal personal consultation and enlightenment programmes.

CONCLUSIONS: This study revealed the contribution of ECEFBSC on reduction of suicide mortalities, especially hanging, charcoal-burning and jumping suicides, via enhancement of regional suicide prevention programmes in Japan; however, notably, the ‘means substitution’ from parts of hanging and charcoal burning to jumping is probably generated by EFECBSC. Therefore, these findings provide important aspects for planning evidence-based and cost-effective regional suicide prevention programmes.

PMID:34475170 | DOI:10.1136/bmjopen-2021-049538

BMJ Open. 2021 Sep 2;11(9):e049610. doi: 10.1136/bmjopen-2021-049610.

ABSTRACT

OBJECTIVES: Management of cardiovascular disease (CVD) is an urgent challenge in low-income and middle-income countries, and interventions may require appraisal of patients’ social networks to guide implementation. The purpose of this study is to determine whether egocentric social network characteristics (SNCs) of patients with chronic disease in western Kenya are associated with overall CVD risk and individual CVD risk factors.

DESIGN: Cross-sectional analysis of enrollment data (2017-2018) from the Bridging Income Generation with GrouP Integrated Care trial. Non-overlapping trust-only, health advice-only and multiplex (trust and health advice) egocentric social networks were elicited for each participant, and SNCs representing social cohesion were calculated.

SETTING: 24 communities across four counties in western Kenya.

PARTICIPANTS: Participants (n=2890) were ≥35 years old with diabetes (fasting glucose ≥7 mmol/L) or hypertension.

PRIMARY AND SECONDARY OUTCOMES: We hypothesised that SNCs would be associated with CVD risk status (QRISK3 score). Secondary outcomes were individual CVD risk factors.

RESULTS: Among the 2890 participants, 2020 (70%) were women, and mean (SD) age was 60.7 (12.1) years. Forty-four per cent of participants had elevated QRISK3 score (≥10%). No relationship was observed between QRISK3 level and SNCs. In unadjusted comparisons, participants with any individuals in their trust network were more likely to report a good than a poor diet (41% vs 21%). SNCs for the trust and multiplex networks accounted for a substantial fraction of variation in measures of dietary quality and physical activity (statistically significant via likelihood ratio test, adjusted for false discovery rate).

CONCLUSION: SNCs indicative of social cohesion appear to be associated with individual behavioural CVD risk factors, although not with overall CVD risk score. Understanding how SNCs of patients with chronic diseases relate to modifiable CVD risk factors could help inform network-based interventions.

TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier: NCT02501746; https://clinicaltrials.gov/ct2/show/NCT02501746.

PMID:34475172 | DOI:10.1136/bmjopen-2021-049610

BMJ Open. 2021 Sep 2;11(9):e049123. doi: 10.1136/bmjopen-2021-049123.

ABSTRACT

OBJECTIVES: Derived neutrophil-to-lymphocytes ratio (dNLR) has recently been reported as a novel potential biomarker associated with prognosis of non-small cell lung cancer (NSCLC). However, evidence for the prognostic utility of dNLR in patients with NSCLC treated with immune checkpoint inhibitors (ICIs) remains inconsistent. The objective of this work was to evaluate the association between pretreatment dNLR and prognosis of patients with NSCLC treated with ICIs.

DESIGN: This study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

DATA SOURCES: PubMed, EMBASE, Web of Science and the Cochrane Library were searched for eligible studies up to 16 October 2020. ELIGIBILITY CRITERIA: (1) Human subjects receiving ICIs therapy and who had been diagnosed with NSCLC; (2) the baseline values of dNLR were obtained; (3) the objective of the study was to investigate the relationships between dNLR and overall survival (OS) or progression-free survival (PFS) in NSCLC and (4) HR and 95% CI were displayed in the original article or could be extracted from Kaplan-Meier curves.

DATA EXTRACTION AND SYNTHESIS: Two investigators extracted data independently. Data synthesis was performed via systematic review and meta-analysis of eligible cohort studies. Meta-analysis was performed with Cochran’s Q test and I² statistics. Publication bias of studies was assessed by Begg’s test and Egger’s test. We used V.12.0 of the Stata statistical software.

RESULTS: This analysis included eight studies (2456 cases) on the prognostic utility of dNLR in ICI therapy for NSCLC. The results indicate that higher dNLR significantly predicted poor OS (HR=1.65, 95% CI 1.46 to 1.88; p<0.001) and PFS (HR=1.38, 95% CI 1.23 to 1.55; p<0.001). Subgroup analyses of OS-related studies indicated that there were similar results in stratifications by ethnicity, sample size, type of HR and dNLR cut-off value. As for PFS-related studies, subgroup analyses showed no significant difference in Asian populations. Publication biases were not detected using Begg’s test and Egger’s linear regression test.

CONCLUSIONS: This meta-analysis indicated that elevated pretreatment dNLR may be a negative prognostic predictor for patients with NSCLC treated with ICIs. More large-sample and higher-quality studies are warranted to support our findings.

PROSPERO REGISTRATION NUMBER: CRD42021214034.

PMID:34475167 | DOI:10.1136/bmjopen-2021-049123

BMJ Open. 2021 Sep 2;11(9):e049212. doi: 10.1136/bmjopen-2021-049212.

ABSTRACT

INTRODUCTION: Idiopathic congenital talipes equinovarus (CTEV) is the most common congenital limb deformity. Non-operative intervention using the Ponseti method has shown to be superior to soft tissue release and has become the gold standard for first-line treatment. However, numerous deviations from the Ponseti protocol are still reported following incomplete correction or deformity relapse. Significant variation in treatment protocols and management is evident in the literature. Reducing geographical treatment variation has been identified as one of The James Lind Alliance priorities in children’s orthopaedics. For this reason, the British Society of Children’s Orthopaedic Surgery (BSCOS) commissioned a consensus document to form a benchmark for practitioners and ensure consistent high quality care for children with CTEV.

METHODS AND ANALYSIS: The consensus will follow an established Delphi approach aiming at gaining an agreement on the items to be included in the consensus statement for the management of primary idiopathic CTEV up to walking age. The process will include the following steps: (1) establishing a steering group, (2) steering group meetings, (3) a two-round Delphi survey aimed at BSCOS members, (4) final consensus meeting and (5) dissemination of the consensus statement. Degree of agreement for each item will be predetermined. Descriptive statistics will be used for analysis of the Delphi survey results.

ETHICS AND DISSEMINATION: No patient involvement is required for this project. Informed consent will be assumed from participants taking part in the Delphi survey. Study findings will be published in an open access journal and presented at relevant national and international conferences. Charities and associations will be engaged to promote awareness of the consensus statement.

PMID:34475168 | DOI:10.1136/bmjopen-2021-049212

BMJ Open. 2021 Sep 2;11(9):e047142. doi: 10.1136/bmjopen-2020-047142.

ABSTRACT

INTRODUCTION: For over more than a decade, low-dose amitriptyline and mirtazapine are prescribed off-label for insomnia. However, placebo-controlled evidence on these antidepressants for insomnia is still lacking. Therefore, the present trial aims to assess the effectiveness of low-dose amitriptyline (10-20 mg/day) and mirtazapine (7.5-15 mg/day) in patients with insomnia disorder with difficulty maintaining sleep or early-morning awakening problems in general practice.

METHODS AND ANALYSIS: The Drug REdiscovery: low-dose Amitriptyline and Mirtazapine for INsomnia disorder in General practice (DREAMING) study is a randomised, double-blind, placebo-controlled trial in about 50 general practices. Adults (18-85 years) with insomnia disorder (Diagnostic and Statistical Manual of Mental Disorders-5) who ask their general practitioner (GP) for sleep medication when non-pharmacological treatment is deemed not effective, are eligible.

EXCLUSION CRITERIA: isolated sleep initiation problem, contraindications for or drug-drug interactions with either amitriptyline or mirtazapine. Participants (n=156) will be randomly assigned to three parallel treatment groups of 16-week treatment with either amitriptyline (one or two tablets of 10 mg/day) or mirtazapine (one or two tablets of 7.5 mg/day) or placebo (one or two tablets) alongside usual GP care. All participants start and end with single dose, but dose can be doubled following GP consultation in week 3. Questionnaire assessments will be conducted at baseline, week 6, 12, 20 and 52. The primary study outcome is self-reported insomnia severity at 6 weeks, measured with the Insomnia Severity Index (ISI) in an intention to treat analysis. Secondary outcomes include subjective sleep quality quantified by sleep indices, daytime functioning and symptoms, safety and treatment evaluation and other sleep care consumption.

ETHICS AND DISSEMINATION: The Medical Ethics Committee of the VU Medical Centre Amsterdam approved this trial. The results of this trial will be published in peer-reviewed scientific journals and presented at relevant academic conferences and to key stakeholders.

TRIAL REGISTRATION NUMBER: NTR7449.

PMID:34475156 | DOI:10.1136/bmjopen-2020-047142

BMJ Open. 2021 Sep 2;11(9):e045239. doi: 10.1136/bmjopen-2020-045239.

ABSTRACT

INTRODUCTION: The emphasis on aesthetic outcomes and quality of life (QoL) has motivated surgeons to develop skin-sparing or nipple-sparing mastectomy (SSM/ NSM) for breast cancer treatment or prevention. During the same operation, a so-called immediate breast reconstruction is performed. The breast can be reconstructed by positioning of a breast implant above (prepectoral) or below (subpectoral) the pectoralis major muscle or by using the patients’ own tissue (autologous reconstruction). The optimal positioning of the implant prepectoral or subpectoral is currently not clear. Subpectoral implant-based breast reconstruction (IBBR) is still standard care in many countries, but prepectoral IBBR is increasingly performed. This heterogeneity in breast reconstruction practice is calling for randomised clinical trials (RCTs) to guide treatment decisions.

METHODS AND ANALYSIS: International, pragmatic, multicentre, randomised, superiority trial. The primary objective of this trial is to test whether prepectoral IBBR provides better QoL with respect to long-term (24 months) physical well-being (chest) compared with subpectoral IBBR for patients undergoing SSM or NSM for prevention or treatment of breast cancer. Secondary objectives will compare prepectoral versus subpectoral IBBR in terms of safety, QoL and patient satisfaction, aesthetic outcomes and burden on patients. Total number of patients to be included: 372 (186 per arm).

ETHICS AND DISSEMINATION: This study will be conducted in compliance with the Declaration of Helsinki. Ethical approval has been obtained for the lead investigator’s site by the Ethics Committee ‘Ethikkommission Nordwest- und Zentralschweiz’ (2020-00256, 26 March 2020). The results of this study will be published in a peer-reviewed medical journal, independent of the results, following the Consolidated Standards of Reporting Trials standards for RCTs and good publication practice. Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on public repositories adhering to the FAIR (Findability, Accessibility, Interoperability, and Reuse) principles.

TRIAL REGISTRATION NUMBER: NCT04293146.

PMID:34475143 | DOI:10.1136/bmjopen-2020-045239

BMJ Open. 2021 Sep 2;11(9):e045623. doi: 10.1136/bmjopen-2020-045623.

ABSTRACT

OBJECTIVE: The central aim of this study was to assess the level of psychological problems among college students during school closure due to the emerging COVID-19 pandemic.

DESIGN: Institution-based, cross-sectional study.

SETTING: Colleges in the Amhara regional state of Ethiopia.

PARTICIPANTS: Participants were college students (N=422, >18 years) who were actively enrolled in the selected colleges preceding the survey.

METHODS: Data entry was done using Epi Info V.7.02 and data analysis was done using SPSS V.24.0. Variables with a p value less than 0.25 in the bivariate analysis were entered into the multivariable logistic regression model. Model fitness was checked using the Hosmer-Lemeshow model fitness test. Statistically significant level was declared at p<0.05.

OUTCOME: Level of psychological problem.

RESULTS: This study involved 408 students, with a response rate of 96.6%. In this study, 77.2%, 71.8% and 48.5% of students experienced depression, anxiety and stress-related psychological problems during the lockdown, respectively. The multivariable logistic regression model showed that being female (adjusted OR (AOR)=1.68, 95% CI 1.09 to 2.91), inadequate practice of prevention measures (AOR=1.74, 95% CI 1.01 to 3.02) and living in an urban residency (AOR=0.76, 95% CI 0.48 to 0.94) were independent predictors of psychological problems among students.

CONCLUSIONS: The study revealed that the level of anxiety, stress and depression disorders is optimally high among college students. Therefore, local governments should develop effective psychological interventions for students. Moreover, it is important to consider the educational enrolment type and the academic year of students.

PMID:34475145 | DOI:10.1136/bmjopen-2020-045623

BMJ Glob Health. 2021 Sep;6(Suppl 5):e005411. doi: 10.1136/bmjgh-2021-005411.

ABSTRACT

Phone surveys are a rapid and cost-effective way to collect primary data for research, monitoring and evaluation purposes. But for these data to be precise, reliable and unbiased, women’s perspectives must be accurately represented. Throughout 2020, we conducted seven household surveys in rural India to understand households’ experiences of the COVID-19 pandemic and contemporaneous relief programmes. Given social distancing protocols, we conducted these surveys over the phone, using household phone numbers collected during earlier, face-to-face research. Analysing metadata from these surveys (along with women’s responses to questions about phone use), we determine how gaps in phone access inhibit women’s representation in phone surveys. We find that the prevalence of male management of household phones significantly reduces access to female respondents. This is a problem for two reasons. Firstly, men are usually the first to pick up the phone: in two surveys in which we tracked the gender of the person who picked up, men picked up 63.2% and 71.1% of the time, respectively. Moreover, only a small minority of those we reached by phone were able and willing to pass the phone to a household member of the opposite gender, when prompted (with no statistically significant difference between pass rates for women and men). This low immediate pass rate, in combination with low female pickup, led to fewer women respondents. As such, we recommend that researchers dedicate time and resources to taking appointments and making call-backs to reach more women. We also show that the use of female enumerators improves households’ willingness to participate in women-centred surveys, and call for more investment into female enumerator teams.

PMID:34475116 | DOI:10.1136/bmjgh-2021-005411

BMJ Open. 2021 Sep 2;11(9):e044997. doi: 10.1136/bmjopen-2020-044997.

ABSTRACT

INTRODUCTION: Haemophilia A is a rare bleeding disorder caused by defects in coagulation factor VIII (FVIII). Damoctocog alfa pegol (BAY 94-9027, Jivi, Bayer, Germany) is a site-specifically PEGylated, extended-half-life, recombinant FVIII, approved for use in previously treated patients (PTPs) aged ≥12 years with haemophilia A. However, a real-world evidence regarding routine clinical use of damoctocog alfa pegol is limited.

METHODS AND ANALYSIS: HEM-POWR is a multinational, multicentre, non-interventional, prospective, postmarketing cohort study evaluating the effectiveness and safety of real-world treatment with damoctocog alfa pegol. Estimated enrolment is ≥200 PTPs with haemophilia A, receiving damoctocog alfa pegol (on-demand, prophylaxis or intermittent prophylaxis (as per local label)), observed for 36 months. Primary outcomes are total bleeding events and annualised bleeding rate; secondary outcomes include long-term safety, joint health, pharmacokinetics, patient-reported outcomes (PROs) from validated questionnaires and perioperative haemostasis. Where applicable, reasons for switching to damoctocog alfa pegol, choice of treatment regimen and dose will also be captured. Exploratory and descriptive statistical analyses will be performed, and will be stratified by parameters including, but not limited to, prophylaxis regimen and haemophilia severity. Patients can record bleeds and consumption in electronic (e) Diaries, ePROs, and can access non-promotional study information (videos explaining study procedures) via an online patient portal. Optionally, patients can enrol in the LIFE-ACTIVE substudy designed to investigate the relationship between activity (measured by the ActiGraph CP Insight watch) and effectiveness parameters collected from HEM-POWR.

ETHICS AND DISSEMINATION: Study approval was obtained by local independent ethics committees and authorities in participating study centres across Europe, the Americas and Asia. Informed consent from patients or their legal representative is a requirement for participation. The study results will be submitted for publication in a peer-reviewed scientific journal and presented at scientific conferences.

TRIAL REGISTRATION NUMBERS: NCT03932201, EUPAS26416.

PROTOCOL VERSION AND DATE: V.1.2, 27 September 2019.

PMID:34475142 | DOI:10.1136/bmjopen-2020-044997