Role of drug-eluting bead bronchial arterial chemoembolisation in the treatment of non-small cell lung cancer: protocol for a meta-analysis.

BACKGROUND: Non-small cell lung cancer (NSCLC) has a poor prognosis. Transvascular intervention is an important approach for treating NSCLC. Drug-eluting bead bronchial artery chemoembolisation (DEB-BACE) is a technique of using DEBs loaded with chemotherapeutic drugs for BACE. This study aims to conduct a meta-analysis to comprehensively assess the effectiveness and safety of DEB-BACE in treating NSCLC and investigate a novel therapeutic strategy for NSCLC. METHODS AND ANALYSIS: Wanfang, China National Knowledge Infrastructure, Medline (via PubMed), Cochrane Library, Scopus and Embase databases will be searched in November 2024. A meta-analysis will be conducted to assess the effectiveness and safety of DEB-BACE in the treatment of NSCLC. The following keywords will be applied: "Carcinoma, Non-Small-Cell Lung", "Non-Small Cell Lung Cancer", "Drug-Eluting Bead Bronchial Arterial Chemoembolization" and "drug-eluting beads". Reports in Chinese or English comparing the efficacy of DEB-BACE with other NSCLC treatment options will be included. Case reports, single-arm studies, conference papers, abstracts without full text and reports published in languages other than English and Chinese will not be considered. The Cochrane Handbook for Systematic Reviews of Interventions will be used to independently assess the risk of bias for each included study. In case of significant heterogeneity between studies, possible sources of heterogeneity will be explored through subgroup and sensitivity analysis. For the statistical analysis of the data, RevMan V.5.3 will be used. ETHICS AND DISSEMINATION: This meta-analysis will seek publication in a peer-reviewed journal on completion. Ethical approval is not required for this study as it is a database-based study. PROSPERO REGISTRATION NUMBER: CRD42023411392.

Integrating evidence and causal mapping of help-seeking behaviour of migrant women with postpartum depression in Shanghai, China: a scoping review protocol.

INTRODUCTION: The estimated prevalence of postpartum depression (PPD) worldwide, in China, and Shanghai is 17.2%, 18.0% and 23.2%, respectively. In 2021, Shanghai housed a population of 3.2 million childbearing-age migrant women, most of whom migrated to the city with their husbands for economic reasons. There is a general lack of help-seeking behaviour for mental disorders in China due to the perceived risk of social stigmatisation. In Shanghai, 70% of women did not seek professional help for perinatal mental health problems. We aim to gather information from multiple perspectives, such as the migrant women with PPD and perinatal depression (PND), their caregivers, health service providers and communities, to understand the help-seeking behaviour of postpartum migrant women with PPD or PND in China. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework for Scoping Reviews will guide this review. A bilingual research librarian developed a comprehensive search strategy to retrieve published and unpublished English and Chinese studies involving factors influencing women's PPD or PND help-seeking behaviour in China. This literature includes perceptions, views, patterns, acceptance and refusal, tendencies, probability, service accessibility and utilisation, and facts. We will search PubMed, Embase, Web of Science and CINAHL for English literature and CINKI for Chinese literature. Backward and forward snowball approaches will be used to identify additional relevant papers from the reference lists of selected papers. Two independent reviewers will screen the title and abstract and review the full text of selected papers to identify eligible articles for data extraction. We will build a Microsoft Access database to record the extracted data. The results will be presented in tables and a causal map to demonstrate the relationships between extracted variables and help-seeking behaviours for PPD and PND. A conceptual simulation model will be formulated based on the information from the literature to validate the logic of the relationships between variables, identify knowledge gaps and gain insights into potential intervention approaches. Experts and stakeholders will be invited to critique and comment on the results during group model building (GMB) workshops in Shanghai. These comments will be essential to validate the findings, receive feedback and obtain additional insights. ETHICS AND DISSEMINATION: The literature review component of our study does not require ethical approval because the information and data collected will be obtained from publicly available sources and will not involve human subjects. Our collaborating research partner, International Peach Maternal Child Hospital, obtained the IRB approval (GKLW-A-2023-020-01) for screening and enrolling participants in GMB workshops. Stanford University received IRB approval under protocol number 67 419. The full review will be presented at a relevant conference and submitted to a peer-reviewed scientific journal for publication to report findings.

Health literacy - study protocol for LiSa cohort study.

BACKGROUND: Health literacy is the degree to which individuals have the ability to find, understand, and use information and services to inform health-related decisions and actions for themselves and others, whether at home, at the workplace, in the community, marketplace, healthcare sector, or the political arena. The main aim of this project is to measure health literacy in the adult population living in the municipality of Leiria over the next 10 years. As secondary objectives it is intended to characterize anxiety and depression, metabolic risk and health behaviors in the same population and over the same period. METHODS: This is a prospective cohort study that collects data on HL, anxiety and depression, health characteristics, health behavior and sociodemographic data. The study population will be composed by adults (≥ 18 years old) who are non-institutionalized and living in private households in Leiria. The random sample is stratified by gender and age groups. A face-to-face interview will be conducted with the Computer Assisted Personal Interview at baseline. Follow-up will be carried out every 2 years via telephone call. The association between independent variables and health literacy is examined by means of variance analysis with measurement repetition, and taking into consideration follow-up. DISCUSSION: The LiSa project is a population-based study, derived from a random sampling technique that will allow the analysis of health outcomes in a representative sample of the population of the municipality of Leiria. The LiSa study will be a valuable resource for epidemiological research, as it will provide fundamental information to improve public health policies regarding health literacy in Portugal. TRIAL REGISTRATION: Clinical trials: NCT05558631 (registered on 26/09/2022).

InCHARGE: Co-creating, implementing and evaluating interventions to utilize nurses' competence and achieve person-centred fundamental care-A research protocol describing an action research approach.

AIM AND OBJECTIVES: This research protocol presents an action research project with the aim to demonstrate the value of person-centred fundamental care to nurses and nurse managers in surgical care units to encourage a far-reaching change in this direction. The objectives are to describe this process and to evaluate the effects on missed nursing care and person-centred fundamental care. METHODS: In a novel collaboration between nursing science and medical humanities the action research design will be used to interact with nursing staff and leaders in three surgical care units and design interventions with the purpose to affect the direction of nursing. Initially, the care units will be presented with interactive workshops including evidence-based education on person-centered fundamental care, person-centredness, nurse role responsibility and leadership. This will be followed by cocreation of interventions to stimulate person-centered fundamental care. The Fundamentals of Care framework will be used as the overarching theoretical framework. Data on missed nursing care, person-centred climate and person-centered fundamental care will be collected repeatedly from patient- and nursing stakeholders through interviews and validated questionnaires. Additionally, data from written reflections following clinical observations and focus group interviews will be included. The duration of the study will be approximately five years from ethical approval. DISCUSSION: It has been previously reported that the current working environments of registered nurses are forcing them to ration their caring responsibilities, leading to a lack of fulfillment of patients' fundamental care needs, with possible severe consequences for patients. The action research design helps researchers gain an understanding of the contextual factors important for forthcoming interventions, enabling reflective processes and cocreation of interventions with stakeholders. This may lead to feasible interventions and strengthen nursing leadership in the involved units.

Just-in-time adaptive interventions for adolescent and young adult health and well-being: protocol for a systematic review.

INTRODUCTION: Health behaviours such as exercise and diet strongly influence well-being and disease risk, providing the opportunity for interventions tailored to diverse individual contexts. Precise behaviour interventions are critical during adolescence and young adulthood (ages 10-25), a formative period shaping lifelong well-being. We will conduct a systematic review of just-in-time adaptive interventions (JITAIs) for health behaviour and well-being in adolescents and young adults (AYAs). A JITAI is an emerging digital health design that provides precise health support by monitoring and adjusting to individual, specific and evolving contexts in real time. Despite demonstrated potential, no published reviews have explored how JITAIs can dynamically adapt to intersectional health factors of diverse AYAs. We will identify the JITAIs' distal and proximal outcomes and their tailoring mechanisms, and report their effectiveness. We will also explore studies' considerations of health equity. This will form a comprehensive assessment of JITAIs and their role in promoting health behaviours of AYAs. We will integrate evidence to guide the development and implementation of precise, effective and equitable digital health interventions for AYAs. METHODS AND ANALYSIS: In adherence to Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines, we will conduct a systematic search across multiple databases, including CENTRAL, MEDLINE and WHO Global Index Medicus. We will include peer-reviewed studies on JITAIs targeting health of AYAs in multiple languages. Two independent reviewers will conduct screening and data extraction of study and participant characteristics, JITAI designs, health outcome measures and equity considerations. We will provide a narrative synthesis of findings and, if data allows, conduct a meta-analysis. ETHICS AND DISSEMINATION: As we will not collect primary data, we do not require ethical approval. We will disseminate the review findings through peer-reviewed journal publication, conferences and stakeholder meetings to inform participatory research. PROSPERO REGISTRATION NUMBER: CRD42023473117.

Improving laboratory animal genetic reporting: LAG-R guidelines.

The biomedical research community addresses reproducibility challenges in animal studies through standardized nomenclature, improved experimental design, transparent reporting, data sharing, and centralized repositories. The ARRIVE guidelines outline documentation standards for laboratory animals in experiments, but genetic information is often incomplete. To remedy this, we propose the Laboratory Animal Genetic Reporting (LAG-R) framework. LAG-R aims to document animals' genetic makeup in scientific publications, providing essential details for replication and appropriate model use. While verifying complete genetic compositions may be impractical, better reporting and validation efforts enhance reliability of research. LAG-R standardization will bolster reproducibility, peer review, and overall scientific rigor.

Optimization of the extraction process for Shenshou Taiyi powder based on Box-Behnken experimental design, standard relation, and FAHP-CRITIC methods.

BACKGROUND: Ancient classic prescription play a crucial role in the preservation and advancement of traditional Chinese medicine (TCM) theories. They represent a significant milestone in the ongoing development and transmission of TCM knowledge and practices and are considered one of the breakthroughs in the development of TCM inheritance. In the process of developing ancient classic prescriptions, many problems may still arise in ensuring quality consistency between traditional methods and modern production processes, among which the extraction process poses major challenges. This paper introduces a practical approach extracting an ancient classic prescription using a modern extraction process. The technique is demonstrated through the study of the extraction process of Shenshou Taiyi powder (STP). METHODS: This study focuses on optimising the STP extraction process to ensure consistency in the quality of the product obtained through ancient and modern processes using the standard relation and fuzzy analytic hierarchical process (FAHP) and criteria importance through intercriteria correlation (CRITIC) method integrated weights combined with the Box-Behnken response surface test. Using the contents of rosmarinic acid, isoimperatorin, puerarin, as well as the extract yield and fingerprint similarity as evaluation indexes of STP, the Box-Behnken response surface method was employed to examine the varying extraction parameters, including water addition ratio, extraction duration, and number of extractions. The weighted coefficients for each parameter were calculated by combining the benchmark correlation and FAHP-CRITIC method, deriving a comprehensive score. RESULTS: The optimal extraction process for STP consisted of a two extractions, each using at a tenfold quantity of water, performed for one hour. Process verification across three separate batches yielded a comprehensive score of 94.7, with a relative standard deviation of 0.76%. CONCLUSIONS: The application of the Box-Behnken response surface method combined with standard relation and FAHP-CRITIC approach proved to be stable and feasible for optimising the extraction process of STP.

Tutorial on Biostatistics: Sample Size and Power Calculation for Ophthalmic Studies With Correlated Binary Eye Outcomes.

Purpose: To describe and demonstrate sample size and power calculation for ophthalmic studies with a binary outcome from one or both eyes. Methods: We describe sample size and power calculation for four commonly used eye designs: (1) one-eye design or person-design: one eye per subject or outcome is at person-level; (2) paired design: two eyes per subject and two eyes are in different treatment groups; (3) two-eye design: two eyes per subject and both eyes are in the same treatment group; and (4) mixture design: mixture of one eye and two eyes per subject. For each design, we demonstrate sample size and power calculations in real ophthalmic studies. Results: Using formulas and commercial or free statistical packages including SAS, STATA, R, and PS, we calculated sample size and power. We demonstrated that different statistical packages require different parameters and provide similar, yet not identical, results. We emphasize that studies using data from two eyes of a subject need to account for the intereye correlation for appropriate sample size and power calculations. We demonstrate the gain in efficiency in designs that include two eyes of a subject compared to one-eye designs. Conclusions: Ophthalmic studies use different eye designs that include one or both eyes in the same or different treatment groups. Appropriate sample size and power calculations depend on the eye design and should account for intereye correlation when two eyes from some or all subjects are included in a study. Calculations can be executed using formulas and commercial or free statistical packages.

Ngulluk Moort, Ngulluk Boodja, Ngulluk Wirin (our family, our country, our spirit): An Aboriginal Participatory Action Research study protocol.

Globally, Indigenous children have historical and contemporary connections with government child protection services that have caused significant harm to their long-term health and wellbeing. Innovative, culturally secure and recovery focussed service provision is required. This paper describes a research protocol that has been designed by Indigenous researchers led by Indigenous Elders, to explore culturally secure care planning and service delivery in out-of-home care agencies in Australia. Using participatory action research methods, we will collect data using a variety of forums, including focus groups and semi-structured interviews. These data will explore the challenges for out-of-home care agencies in providing culturally secure care-planning, cultural activity and resources, and explore solutions to address factors that influence health and can assist to redress social inequities for Indigenous children. We aim to recruit approximately 100 participants for the qualitative study and 40 participants for the quantitative survey. Study participants will initially be recruited using purposive sampling, and as the study progresses will be recruited using a mixture of purposive and convenience sampling techniques. The rich data that this study is expected to yield, will inform ways to collect cultural information about Indigenous children and ways to provide cultural connections and activities that will have benefit to Indigenous children and families, and a broad range of social services.

Targeted psychological and psychosocial interventions for auditory hallucinations in persons with psychotic disorders: Protocol for a systematic review and meta-analysis.

BACKGROUND: In recent years, a growing body of evidence has demonstrated the efficacy of non-pharmacological interventions for schizophrenia spectrum disorders (SSD) including positive symptoms such as auditory hallucinations (AH). However, clinical trials predominantly examine general treatment effects for positive symptoms. Therefore, previous research is lacking in comprehensive and clear evidence about psychological and psychosocial approaches that are primarily tailored to treat AH. To overcome this knowledge gap in the current literature, we will conduct a systematic review and meta-analysis to assess the efficacy of clearly targeted psychological and psychosocial interventions for AH in persons with SSD. METHODS AND ANALYSIS: This study protocol has been developed according to the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. We will include all randomized controlled trials analyzing the efficacy of targeted psychological and psychosocial interventions especially aimed at treating AH in SSD. We will include studies on adult patients with SSD experiencing AH. The primary outcome will be the change on a published rating scale measuring AH. Secondary outcomes will be delusions, overall symptoms, negative symptoms, depression, social functioning, quality of life, and acceptability (drop-out). We will search relevant databases and the reference lists of included literature. The study selection process will be conducted by two independent reviewers. We will conduct a random-effect meta-analysis to consider heterogeneity across studies. Analyses will be carried out by software packages in R. The risk of bias in each study will be evaluated using the Cochrane Risk of Bias tool. Assessment of heterogeneity and sensitivity analysis will be conducted. DISCUSSION: The proposed study will augment the existing evidence by providing an overview of effective treatment approaches and their overall efficacy at treating AH in SSD. These findings will complement existing evidence that may impact future treatment implementations in clinical practice by addressing effective strategies to treat AH and therefore improve outcomes for the addressed population. ETHICS AND DISSEMINATION: No ethical issues are foreseen. We will publish the results from this study in peer-reviewed journals and at relevant scientific conferences. TRIAL REGISTRATION: PROSPERO registration number: CRD42023475704.

Sample size calculation for data reliability and diagnostic performance: a go-to review.

Sample size, namely the number of subjects that should be included in a study to reach the desired endpoint and statistical power, is a fundamental concept of scientific research. Indeed, sample size must be planned a priori, and tailored to the main endpoint of the study, to avoid including too many subjects, thus possibly exposing them to additional risks while also wasting time and resources, or too few subjects, failing to reach the desired purpose. We offer a simple, go-to review of methods for sample size calculation for studies concerning data reliability (repeatability/reproducibility) and diagnostic performance. For studies concerning data reliability, we considered Cohen's κ or intraclass correlation coefficient (ICC) for hypothesis testing, estimation of Cohen's κ or ICC, and Bland-Altman analyses. With regards to diagnostic performance, we considered accuracy or sensitivity/specificity versus reference standards, the comparison of diagnostic performances, and the comparisons of areas under the receiver operating characteristics curve. Finally, we considered the special cases of dropouts or retrospective case exclusions, multiple endpoints, lack of prior data estimates, and the selection of unusual thresholds for α and ß errors. For the most frequent cases, we provide example of software freely available on the Internet.Relevance statement Sample size calculation is a fundamental factor influencing the quality of studies on repeatability/reproducibility and diagnostic performance in radiology.Key points• Sample size is a concept related to precision and statistical power.• It has ethical implications, especially when patients are exposed to risks.• Sample size should always be calculated before starting a study.• This review offers simple, go-to methods for sample size calculations.

Sample Size Determination and Study Design Impact on Dose-Scale Pharmacodynamic Bioequivalence: a Case Study Using Orlistat.

Dose-scale pharmacodynamic bioequivalence is recommended for evaluating the consistency of generic and innovator formulations of certain locally acting drugs, such as orlistat. This study aimed to investigate the standard methodology for sample size determination and the impact of study design on dose-scale pharmacodynamic bioequivalence using orlistat as the model drug. A population pharmacodynamic model of orlistat was developed using NONMEM 7.5.1 and utilized for subsequent simulations. Three different study designs were evaluated across various predefined relative bioavailability ratios of test/reference (T/R) formulations. These designs included Study Design 1 (2×1 crossover with T1 60 mg, R1 60 mg, and R2 120 mg), Study Design 2 (2×1 crossover with T2 120 mg, R1 60 mg, and R2 120 mg), and Study Design 3 (2×2 crossover with T1 60 mg, T2 120 mg, R1 60 mg, and R2 120 mg). Sample sizes were determined using a stochastic simulation and estimation approach. Under the same T/R ratio and power, Study Design 3 required the minimum sample size for bioequivalence, followed by Study Design 1, while Study Design 2 performed the worst. For Study Designs 1 and 3, a larger sample size was needed on the T/R ratio < 1.0 side for the same power compared to that on the T/R ratio > 1.0 side. The opposite asymmetry was observed for Study Design 2. We demonstrated that Study Design 3 is most effective for reducing the sample size for orlistat bioequivalence studies, and the impact of T/R ratio on sample size shows asymmetry.

Development of the DONOR prediction model on the risk of hypertensive complications in oocyte donation pregnancy: study protocol for a multicentre cohort study in the Netherlands.

INTRODUCTION: Oocyte donation (OD) pregnancy is accompanied by a high incidence of hypertensive complications, with serious consequences for mother and child. Optimal care management, involving early recognition, optimisation of suitable treatment options and possibly eventually also prevention, is in high demand. Prediction of patient-specific risk factors for hypertensive complications in OD can provide the basis for this. The current project aims to establish the first prediction model on the risk of hypertensive complications in OD pregnancy. METHODS AND ANALYSIS: The present study is conducted within the DONation of Oocytes in Reproduction project. For this multicentre cohort study, at least 541 OD pregnancies will be recruited. Baseline characteristics and obstetric data will be collected. Additionally, one sample of maternal peripheral blood and umbilical cord blood after delivery or a saliva sample from the child will be obtained, in order to determine the number of fetal-maternal human leucocyte antigen mismatches. Following data collection, a multivariate logistic regression model will be developed for the binary outcome hypertensive complication 'yes' and 'no'. The Prediction model Risk Of Bias ASsessment Tool will be used as guide to minimise the risk of bias. The study will be reported in line with the 'Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis' guideline. Discrimination and calibration will be determined to assess model performance. Internal validation will be performed using the bootstrapping method. External validation will be performed with the 'DONation of Oocytes in Reproduction individual participant data' dataset. ETHICS AND DISSEMINATION: This study is approved by the Medical Ethics Committee LDD (Leiden, Den Haag, Delft), with protocol number P16.048 and general assessment registration (ABR) number NL56308.058.16. Further results will be shared through peer-reviewed journals and international conferences.

Role of central endpoint adjudication and challenges in trials on neonatal sepsis-a case of ProSPoNS trial.

Despite progress in reducing the infant mortality in India, the neonatal mortality decline has been slower, necessitating concerted efforts to achieve Sustainable Development Goal-3. A promising strategy aiming to prevent neonatal sepsis in high-risk, vulnerable, low birth weight neonates through an innovative intervention includes probiotic supplementation. This article communicates the decision by the ProSPoNS trial investigators to establish a Central Endpoint Adjudication Committee (CEAC) as an addendum to the protocol published in Trials in 2021 for the purpose of clarifying the primary outcome. In the published protocol, the study hypothesis and primary objective are based on "sepsis," the primary outcome has been specified as sepsis/PSBI, whereas the sample size estimation was performed based on the "physician diagnosed sepsis." To align all the three above, the investigators meeting, held on 17th-18th August 2023, at MGIMS Sevagram, Wardha, deliberated and unanimously agreed that "physician diagnosed sepsis" is the primary study outcome which includes sepsis/PSBI. The CEAC, chaired by an external subject expert and members including trial statistician, a microbiologist, and all site principal investigators will employ four criteria to determine "physician diagnosed sepsis": (1) blood culture status, (2) sepsis screen status, (3) PSBI/non-PSBI signs and symptoms, and (4) the clinical course for each sickness event. Importantly, this clarification maintains consistency with the approved study protocol (Protocol No. 5/7/915/2012 version 3.1 dated 14 Feb 2020), emphasizing the commitment to methodological transparency and adherence to predefined standards. The decision to utilize the guidance of a CEAC is recommended as the gold standard in multicentric complex clinical trials to achieve consistency and accuracy in assessment of outcomes.Trial registrationClinical Trial Registry of India (CTRI) CTRI/2019/05/019197. Registered on 16 May 2019.

Reporting quality of published reviews of commercial and publicly available mobile health apps (mHealth app reviews): a scoping review protocol.

INTRODUCTION: Reviews of commercial and publicly available smartphone (mobile) health applications (mHealth app reviews) are being undertaken and published. However, there is variation in the conduct and reporting of mHealth app reviews, with no existing reporting guidelines. Building on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we aim to develop the Consensus for APP Review Reporting Items (CAPPRRI) guidance, to support the conduct and reporting of mHealth app reviews. This scoping review of published mHealth app reviews will explore their alignment, deviation, and modification to the PRISMA 2020 items for systematic reviews and identify a list of possible items to include in CAPPRRI. METHOD AND ANALYSIS: We are following the Joanna Briggs Institute approach and Arksey and O'Malley's five-step process. Patient and public contributors, mHealth app review, digital health research and evidence synthesis experts, healthcare professionals and a specialist librarian gave feedback on the methods. We will search SCOPUS, CINAHL Plus, AMED, EMBASE, Medline, APA PsycINFO and the ACM Digital Library for articles reporting mHealth app reviews and use a two-step screening process to identify eligible articles. Information on whether the authors have reported, or how they have modified the PRISMA 2020 items in their reporting, will be extracted. Data extraction will also include the article characteristics, protocol and registration information, review question frameworks used, information about the search and screening process, how apps have been evaluated and evidence of stakeholder engagement. This will be analysed using a content synthesis approach and presented using descriptive statistics and summaries. This protocol is registered on OSF (https://osf.io/5ahjx). ETHICS AND DISSEMINATION: Ethical approval is not required. The findings will be disseminated through peer-reviewed journal publications (shared on our project website and on the EQUATOR Network website where the CAPPRRI guidance has been registered as under development), conference presentations and blog and social media posts in lay language.

Homes Heat Health protocol: an observational cohort study measuring the effect of summer temperatures on sleep quality.

INTRODUCTION: Quality sleep is essential to our health and well-being. Summertime temperatures in the bedrooms of homes in temperate climates are increasing, especially in city apartments. There is very little empirical evidence of the effect of temperature on sleep when people are sleeping in their own bedroom. The Homes Heat Health project seeks to develop a measurable definition of temperature-related sleep disturbance and the effects on health, and so produce a credible criterion for identifying overheating in new and existing homes. METHODS AND ANALYSIS: A cohort of at least 95 people that live in London apartments and who are free of significant personal and health factors that could affect sleep are being recruited for an ongoing observational cohort study. A baseline questionnaire determines their customary sleep patterns and health. The geometrical form and thermal characteristics of their apartments is being recorded along with temperature, relative humidity and in some apartments CO2 levels, throughout one summer. Actigraphy records nightly sleep disturbance and every morning an app-based diary captures perceived sleep quality. Questionnaires following spells of hot weather capture changes in sleep pattern, sleep quality, and consequential health and well-being. ETHICS AND DISSEMINATION: The study protocol was approved by the Loughborough University ethics committee. The participants will receive both verbal and written information explaining the purpose of the study, what is expected of them, the incentives for participating and the feedback that will be provided. The results will be reported bi-annually to a project advisory board. Presentations will be made at conferences and the methods, intermediary and final results, in academic journals. Informing government bodies, professional organisations, construction industry representatives and housing providers is of particular importance.

Suicidal behaviours and associated factors among medical students in Bangladesh: a protocol for systematic review and meta-analysis (2000-2024).

INTRODUCTION: Suicidal behaviour is common among medical students, and the prevalence rates might vary across various regions. Even though various systematic reviews have been conducted to assess suicidal behaviours among medical students in general, no review has ever assessed or carried out a sub-analysis to show the burden of suicidal behaviours among Bangladeshi medical students. METHODS AND ANALYSIS: The research team will search the PubMed (Medline), Scopus, PsycINFO and Google Scholar databases for papers published between January 2000 and May 2024 using truncated and phrase-searched keywords and relevant subject headings. Cross-sectional studies, case series, case reports and cohort studies published in English will be included in the review. Review papers, commentaries, preprints, meeting abstracts, protocols and letters will be excluded. Two reviewers will screen the retrieved papers independently. Disagreements between two reviewers will be resolved by a third reviewer. Exposure will be different factors that initiate suicidal behaviours among medical students. The prevalence of suicidal behaviours (suicidal ideation, suicide plans and suicide attempts) in addition to the factors responsible, and types of suicide method will be extracted. Narrative synthesis and meta-analysis will be conducted and the findings will be summarised. For enhanced visualisation of the included studies, forest plots will be constructed. Heterogeneity among the studies will be assessed and sensitivity analysis will be conducted based on study quality. Included studies will be critically appraised using Joanna Briggs's Institutional critical appraisal tools developed for different study designs. ETHICS AND DISSEMINATION: The study will synthesise evidence extracted from published studies. As the review does not involve the collection of primary data, ethical approval will not be required. Findings will be disseminated orally (eg, conferences, webinars) and in writing (ie, journal paper). PROSPERO REGISTRATION NUMBER: CDR 42023493595.

Community perspective and healthcare assessment in malaria endemic states of India: a cross-sectional study protocol.

INTRODUCTION: India's contribution to the malaria burden was highest in South-East Asia Region in 2021, accounting for 79% of the estimated malaria cases and 83% of malaria-related deaths. Intensified Malaria Control Programme supported by Global Funds to Fight against AIDS, Tuberculosis and Malaria has deployed crucial interventions to reduce the overall burden of malaria in India. Evaluation of utilisation of malaria elimination interventions by the community and assessment of the healthcare system is underway in eleven high malaria endemic states in India. Health system preparedness for malaria elimination, logistics, and supply chain management of diagnostic kits and anti-malarial drugs in addition to the knowledge, attitude and practice of the healthcare workers is also being assessed. METHODS AND ANALYSIS: The study is being undertaken in 11 malaria endemic states with a variable annual parasite incidence of malaria. In total, 47 districts (administrative unit of malaria control operations) covering 37 976 households are to be interviewed and assessed. We present here the protocol following which the study is being undertaken at the behest and approval of Ministry of Health and Family Welfare in India. ETHICS AND DISSEMINATION: No patients were involved in the study. Study findings will be shared with Institutional ethics board of National Institute for Malaria Research New Delhi (NIMR) in a timely, comprehensive, accurate, unbiased, unambiguous and transparent manner and to the National Vector-borne Disease (Malaria) Control Programme officers and the Community public who participated. Important findings will be communicated through community outreach meetings which are existing in the Health system. Results will be informed to study participants via local fieldwork supervised by District Malaria Officers. Also findings will be published in reputed journals based on Indian Council of Medical Research (ICMR) publication policy.The ICMR-NIMR ethics committee approved the study via letter No. NIMR/ECM/2023/Feb/14 dated 24 April 2023 for version 5. All standard ethical practices will be followed.

Ginseng supplementation and cardiovascular disease risk factors: a protocol for GRADE-assessed systematic review and dose-response meta-analysis.

INTRODUCTION: Heart diseases constitute a significant global public health concern. Cardiovascular diseases (CVDs) are characterised by disruptions in blood circulation and are notably prevalent among adults exposed to Westernised diets. Ginseng, a medicinal plant, has been recognised for its healing properties and has a history of use spanning thousands of years. This systematic review aims to evaluate the efficacy of ginseng in modifying risk factors for CVD, including lipid profiles, glycaemic control, anthropometric indices, inflammation indicators, blood pressure, oxidative stress, liver function tests, adipokines and heart rate among individuals aged 18 and above, encompassing both genders. METHODS AND ANALYSIS: We will conduct an electronic search for articles published from inception to September 2023 using a predefined search strategy in PubMed, Scopus, Web of Science, CENTRAL and EMBASE. Our search will focus exclusively on randomised controlled clinical trials involving both healthy and unhealthy participants. The process of reviewing articles, extracting pertinent information and assessing the quality of studies using the Cochrane risk of bias tool will be carried out independently by two reviewers. Any discrepancies will be resolved through discussion with a third party. If a sufficient number of eligible studies are identified, a meta-analysis will be conducted using these outcomes. ETHICS AND DISSEMINATION: This study serves as the procedural framework for a comprehensive examination and does not require ethical approval. Additionally, the study adhered to the guidelines outlined in the Declaration of Helsinki. Ethical approval for the study was obtained from the Ethics Committee of Golestan University of Medical Sciences (IR.GOUMS.REC.1402.298). PROSPERO REGISTRATION NUMBER: CRD42023465688.