bluuebunny/crossref_metadata_2025_split huggingface dataset:
Endometrial factors in the implantation failure spectrum: protocol of a MUltidisciplinary observational cohort study in women with Repeated Implantation failure and recurrent Miscarriage (MURIM Study)
Authors: Stevens Brentjens Linda , Habets Denise , Den Hartog Janneke , Al-Nasiry Salwan , Wieten Lotte , Morré Servaas , Van Montfoort Aafke , Romano Andrea , van Golde Ron 
Published: June 2022

IntroductionWomen with repeated implantation failure (RIF) and unexplained recurrent miscarriage (RM) are proposed to be at opposite ends of the implantation spectrum, with RM representing an overly receptive endometrium (implantation of genetically aberrant or poor-quality embryos) versus RIF representing an overly selective endometrium (no implantation even with good quality embryos). In both cases, often no explanation for reproductive failure can be found and although promising add-on treatments have been introduced, therapeutic options are frequently limited to supportive care. Both RM and RIF are multifactorial and research indicates that the interplay between steroidogenesis, uterine natural killer (uNK) cells and the microbiome determine the capacity of the endometrium to be a biosensor for invading embryos. Our objective is to elucidate whether there is a difference in endometrial receptivity parameters (ie, steroid metabolism, uNK cells and the microbiome) between women aged 18–38 years with reproductive failure (RIF and RM), and fertile controls.Methods and analysisSingle-centre, observational cohort study. Endometrial biopsies, vaginal swabs and peripheral blood will be collected during the window of implantation and menstrual blood in the subsequent menstruation. The study parameters are the steroid profile (steroid levels and mRNA levels, protein expression and activity of steroid enzymes) in endometrial tissue and peripheral blood, as well as the activating or inhibitory phenotype of uNK cells based on receptor expression in menstrual blood and endometrial tissue and determination of the vaginal and endometrial microbiome using the inter spacer bacterial profiling technique.Ethics and disseminationThe protocol is approved by the local medical ethical review committee at the Maastricht University Medical Centre. Findings from this study will be shared with the academic and medical community and the patient organisations to optimise and individualise medical care of patients with implantation failure and miscarriages.Trial registration numberNTR7571, registered 28 February 2019.
Systematic review of educational interventions to improve the menstrual health of young adolescent girls
Authors: Evans Rebecca Lane , Harris Bronwyn , Onuegbu Chinwe , Griffiths Frances 
Published: June 2022

ObjectivesTo systematically review interventions that include an element of menstrual education delivered to young adolescent girls.DesignThis was a systematic review and meta-analysis. Selected articles were quality assessed using the Mixed Methods Appraisal Tool quality appraisal checklist. A meta-analysis was conducted on a subset of articles, and the effect size of the intervention was calculated using Cohen’s d. A logic model was constructed to frame the effect of menstrual education interventions on menstrual health.SettingPapers reporting on interventions in high-income and low-income and middle-income countries were sought.Information sourcesSeven electronic databases were searched for English-language entries that were published between January 2014 and May 2020.ParticipantsThe interventions were aimed at younger adolescent girls aged 10–14 years old.InterventionsThe interventions were designed to improve the menstrual health of the recipients, by addressing one or more elements of menstrual knowledge, attitude or practices (KAP).Eligibility criteriaInterventions that had not been evaluated were excluded.Primary and secondary outcomesThe most common type of output was a difference in knowledge or skill score ascertained from a pre and post test. Some studies measured additional outcomes, such as attitude or confidence.ResultsTwenty-four eligible studies were identified. The number of participants varied from 1 to 2564. All studies reported improvements in menstrual KAP. The meta-analysis indicates that larger effect sizes were attained by those that encouraged discussion than those that distributed pamphlets.ConclusionsEducation interventions are effective in increasing the menstrual knowledge of young adolescent girls and skills training improves competency to manage menstruation more hygienically and comfortably. Interactive interventions are more motivating than didactic or written. Sharing concerns gives girls confidence and helps them to gain agency on the path to menstrual health.Trial registration numberFor this review, a protocol was not prepared or registered.
The impact of the COVID-19 pandemic on the research activity and working experience of clinical academics, with a focus on gender and ethnicity: a qualitative study in the UK
Authors: Finn Gabrielle M , Crampton Paul , Buchanan John AG , Balogun Abisola Olatokunbo , Tiffin Paul Alexander , Morgan Jessica Elizabeth , Taylor Ellie , Soto Carmen , Kehoe Amelia 
Published: June 2022

ObjectiveTo investigate the impact of the COVID-19 pandemic on the research activity and working experience of clinical academics, with a focus on gender and ethnicity.DesignQualitative study based on interviews and audio/written diary data.SettingUK study within clinical academia.ParticipantsPurposive sample of 82 clinical academics working in medicine and dentistry across all career stages ranging from academic clinical fellows and doctoral candidates to professors.MethodsQualitative semistructured interviews (n=68) and audio diary data (n=30; including 16 participants who were also interviewed) collected over an 8-month period (January–September 2020), thematically analysed.Results20 of 30 (66.6%) audio diary contributors and 40 of 68 (58.8%) interview participants were female. Of the participants who disclosed ethnicity, 5 of 29 (17.2%) audio diary contributors and 19/66 (28.8%) interview participants identified as Black, Asian or another minority (BAME). Four major themes were identified in relation to the initial impact of COVID-19 on clinical academics: opportunities, barriers, personal characteristics and social identity, and fears and uncertainty. COVID-19 presented opportunities for new avenues of research. Barriers included access to resources to conduct research and the increasing teaching demands. One of the most prominent subthemes within ‘personal characteristics’ was that of the perceived negative impact of the pandemic on the work of female clinical academics. This was attributed to inequalities experienced in relation to childcare provision and research capacity. Participants described differential experiences based upon their gender and ethnicity, noting intersectional identities.ConclusionsWhile there have been some positives afforded to clinical academics, particularly for new avenues of research, COVID-19 has negatively impacted workload, future career intentions and mental health. BAME academics were particularly fearful due to the differential impact on health. Our study elucidates the direct and systemic discrimination that creates barriers to women’s career trajectories in clinical academia. A flexible, strategic response that supports clinical academics in resuming their training and research is required. Interventions are needed to mitigate the potential lasting impact on capacity from the pandemic, and the potential for the loss of women from this valuable workforce.
Economic evaluation of pan-genotypic generic direct-acting antiviral regimens for treatment of chronic hepatitis C in Iran: a cost-effectiveness study
Authors: Tasavon Gholamhoseini Mohammad , Sharafi Heidar , HL Borba Helena , Alavian Seyed Moayed , Sabermahani Asma , Hajarizadeh Behzad 
Published: June 2022

IntroductionLow-cost generic direct-acting antiviral (DAA) regimens for treatment of hepatitis C virus (HCV) are available in several low-income/middle-income countries, important for treatment scale-up. This study evaluated the cost-effectiveness of genotype-dependent and pan-genotypic DAA regimens in Iran as an example of a resource-limited setting.MethodsA Markov model was developed to simulate HCV natural history. A decision tree was developed for HCV treatment, assuming four scenarios, including scenario 1: genotyping, sofosbuvir/ledipasvir (SOF/LDV) for genotype 1, and sofosbuvir/daclatasvir (SOF/DCV) for genotype 3; scenario 2: genotyping, SOF/LDV for genotype 1, and sofosbuvir/velpatasvir (SOF/VEL) for genotype 3; scenario 3: no genotyping and SOF/DCV for all; and scenario 4: no genotyping and SOF/VEL for all. A 1-year cycle length was used to calculate the cumulative cost and effectiveness over a lifetime time horizon. We calculated quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) using a health system perspective. Costs were converted to US dollars using purchasing power parity exchange rate ($PPP). All costs and outcomes were discounted at an annual rate of 3%.ResultsAmong people with no cirrhosis, scenario 3 had the minimum cost, compared with which scenario 4 was cost-effective with an ICER of 4583 $PPP per QALY (willingness-to-pay threshold: 9,311 $PPP per QALY). Among both people with compensated or decompensated cirrhosis, scenario 4 was cost saving. In sensitivity analysis, scenario 4 would be also cost-saving among people with no cirrhosis provided a 39% reduction in the cost of 12 weeks SOF/VEL.ConclusionInitiating all patients on pan-genotypic generic DAA regimens with no pretreatment genotyping was cost-effective compared with scenarios requiring pretreatment HCV genotype tests. Among generic pan-genotypic DAA regimens, SOF/VEL was cost-effective, for people with no cirrhosis and cost-saving for those with cirrhosis.
Effect of traditional Chinese exercise on abnormal lipid metabolism in patients with atherosclerosis: a protocol for meta-analysis of randomised controlled trials
Authors: Wang Chen , Zhang Peizhen , Yang Yuting 
Published: June 2022

IntroductionAtherosclerosis (AS) is an abnormal response within the vessel wall to endothelial dysfunction and inflammatory cellular processes. Taijiquan exercise as a moderate-intensity aerobic exercise can control or reverse AS by gradually reducing the deposition of cholesterol on the walls of blood vessels. Similarly, performing Baduanjin exercise, Liuzijue Qigong, Wuqinxi exercise and Yijinjing exercise has been found to have a positive effect on lipid metabolism in patients with AS. However, these studies focused only on middle-aged and older populations over 50 years of age and had short intervention periods, poor quality control and patient compliance, and no stratification by age and gender to observe the effects of traditional Chinese exercise (TCE) on patients with AS. Therefore, this meta-analysis will explore the specific effects of different TCE interventions on lipid metabolism in patients with AS through subgroup analysis of factors such as age, gender, intervention cycle and training method and lay the foundation of evidence-based medicine for the promotion of TCE in both clinical practice and the community.Methods and analysisA systematic approach will be completed to search the literature published up to 30 September 2021 in the following databases: Web of Science, PubMed, Embase, Cochrane Library, EBSCO and CNKI. Other databases will also be searched manually. Lipid metabolism is the primary outcome indicator. Data synthesis, sensitivity analysis, regression analysis, subgroup analysis and risk bias evaluation will be performed using RevMan V.5.3 software. In addition, funnel plots generated by Begg’s and Egger’s tests will be used to assess reporting bias.Ethics and disseminationEthical approval and consent are not necessary as no primary data will be collected. The results of the study will be disseminated through carefully reviewed publications.PROSPERO registration numberCRD42022304283.
Body mass index, proteinuria and total lymphocyte counts in predicting treatment responses among ART naïve individuals with HIV initiated on antiretroviral treatment in Dar es Salaam, Tanzania, 2019: a cohort study
Authors: Munseri Patricia , Jassely Lazaro , Tumaini Basil , Hertzmark Ellen 
Published: June 2022

ObjectivesTo explore the potential use of body mass index (BMI), proteinuria and total lymphocyte count changes in predicting immunological and virological response in individuals with HIV initiated on antiretroviral treatment (ART).DesignProspective cohort study.SettingThree urban HIV care and treatment centres in Dar es Salaam.ParticipantsIndividuals with HIV initiating ART.Outcome measuresHIV viral load ≥1000 copies/mL (viral non-suppression) at 6 months after ART initiation.ResultsOf 215 (out of 220 enrolled) participants who returned for evaluation at 6 months, 147 (66.8%) were women. At 6 months of follow-up, 89.4% (76/85) of participants with sustained weight gain were virally suppressed compared with 31.8% (7/22) with sustained loss, p<0.001. In participants who were lymphopaenic at baseline, an increase to normal total lymphocyte counts at 6 months was associated with an increase in CD4 count compared with participants who remained lymphopaenic, 96.2% (50/52) versus 54.8% (17/31), p<0.001. At baseline, 50.0% (110/220) had proteinuria. In participants without proteinuria from baseline to 6 months, 89.8% (79/88) were virally suppressed compared with participants with proteinuria at baseline and/or 3 months, 85.6% (77/90), those with persistent proteinuria, 30.8% (8/26), and proteinuria at 6 months only, 45.5% (5/11), p<0.001. In modified Poisson regression, the independent predictors other than CD4 cell counts for viral non-suppression at 6 months among individuals with HIV initiating on ART were BMI loss >5% from baseline to 6 months (adjusted RR 2.73, 95% CI (1.36 to 5.47)), lymphopaenia at 6 months (adjusted RR=4.54, 95% CI (2.19 to 9.39)) and proteinuria at 6 months (adjusted RR=2.63, 95% CI (1.25 to 5.54)).ConclusionsChange in BMI, total lymphocyte count and presence of proteinuria can monitor and predict ART response and may be particularly helpful in settings when CD4 counts and viral load monitoring are unavailable.
Primary motivations for and experiences with paediatric minimally invasive tissue sampling (MITS) participation in Malawi: a qualitative study
Authors: Lawrence Sarah , Namusanya Dave , Mohamed Sumaya B , Hamuza Andrew , Huwa Cornelius , Chasweka Dennis , Kelley Maureen , Molyneux Sassy , Voskuijl Wieger , Denno Donna , Desmond Nicola 
Published: June 2022

ObjectiveTo understand family member consent decision-making influences and experiences in Malawi in order to inform future minimally invasive tissue sampling (MITS) studies.DesignQualitative study.SettingQueen Elizabeth Central Hospital (QECH) in Blantyre, Malawi, which serves as the central referral hospital for southern Malawi and where MITS participants were recruited from.ParticipantsFamilies of paediatric MITS participants.MethodsWe conducted in-depth interviews with 16 families 6 weeks after the death of paediatric MITS participants. Data were analysed using a combination of thematic content and theoretical framework approaches to explain the findings.ResultsImproved cause of death (CoD) ascertainment was the principal motivator for participation to protect remaining or future children. Community burial norms, religious doctrine and relationships with healthcare workers (HCWs) were not reported influencers among family members who consented to the procedure. Primary consenters varied, with single mothers more likely to consent independently or with only female family members present. Clear understanding of MITS procedures appeared limited 6 weeks postprocedure, but research was described as voluntary and preconsent information satisfactory for decision-making. Most families intended to share about MITS only with those involved in the consent process, for fear of rumours or judgement by extended family members and the wider community.ConclusionAmong those who consented to MITS, decision-making was informed by individual and household experiences and beliefs, but not by religious affiliation or experiences with HCWs. While understanding of the MITS procedure was limited at the time of interview, families found informed consent information sufficient for decision-making. Future MITS studies should continue to explore information presentation best practices to facilitate informed consent during the immediate grieving period.
Intervening to eliminate the centre-effect variation in home dialysis use: protocol for Inter-CEPt—a sequential mixed-methods study designing an intervention bundle
Authors: Tshimologo Maatla , Allen Kerry , Coyle David , Damery Sarah , Dikomitis Lisa , Fotheringham James , Hill Harry , Lambie Mark , Phillips-Darby Louise , Solis-Trapala Ivonne , Williams Iestyn , Davies Simon J 
Published: June 2022

IntroductionUse of home dialysis by centres in the UK varies considerably and is decreasing despite attempts to encourage greater use. Knowing what drives this unwarranted variation requires in-depth understanding of centre cultural and organisational factors and how these relate to quantifiable centre performance, accounting for competing treatment options. This knowledge will be used to identify components of a practical and feasible intervention bundle ensuring this is realistic and cost-effective.Methods and analysisUnderpinned by the non-adoption, abandonment, scale-up, spread and sustainability framework, our research will use an exploratory sequential mixed-methods approach. Insights from multisited focused team ethnographic and qualitative research at four case study sites will inform development of a national survey of 52 centres. Survey results, linked to patient-level data from the UK Renal Registry, will populate a causal graph describing patient and centre-level factors, leading to uptake of home dialysis and multistate models incorporating patient-level treatment modality history and mortality. This will inform a contemporary economic evaluation of modality cost-effectiveness that will quantify how modification of factors facilitating home dialysis, identified from the ethnography and survey, might yield the greatest improvements in costs, quality of life and numbers on home therapies. Selected from these factors, using the capability, opportunity and motivation for behaviour change framework (COM-B) for intervention design, the optimal intervention bundle will be developed through workshops with patients and healthcare professionals to ensure acceptability and feasibility. Patient and public engagement and involvement is embedded throughout the project.Ethics and disseminationEthics approval has been granted by the Health Research Authority reference 20-WA-0249. The intervention bundle will comprise components for all stake holder groups: commissioners, provider units, recipients of dialysis, their caregivers and families. To reache all these groups, a variety of knowledge exchange methods will be used: short guides, infographics, case studies, National Institute for Health and Care Excellence guidelines, patient conferences, ‘Getting it Right First Time’ initiative, Clinical Reference Group (dialysis).
Artificial intelligence-derived gut microbiome as a predictive biomarker for therapeutic response to immunotherapy in lung cancer: protocol for a multicentre, prospective, observational study
Authors: Shoji Fumihiro , Yamashita Takanori , Kinoshita Fumihiko , Takamori Shinkichi , Fujishita Takatoshi , Toyozawa Ryo , Ito Kensaku , Yamazaki Koji , Nakashima Naoki , Okamoto Tatsuro 
Published: June 2022

IntroductionImmunotherapy is the fourth leading therapy for lung cancer following surgery, chemotherapy and radiotherapy. Recently, several studies have reported about the potential association between the gut microbiome and therapeutic response to immunotherapy. Nevertheless, the specific composition of the gut microbiome or combination of gut microbes that truly predict the efficacy of immunotherapy is not definitive.Methods and analysisThe present multicentre, prospective, observational study aims to discover the specific composition of the gut microbiome or combination of gut microbes predicting the therapeutic response to immunotherapy in lung cancer using artificial intelligence. The main inclusion criteria are as follows: (1) pathologically or cytologically confirmed metastatic or postoperative recurrent lung cancer including non-small cell lung cancer and small cell lung cancer; (2) age≥20 years at the time of informed consent; (3) planned treatment with immunotherapy including combination therapy and monotherapy, as the first-line immunotherapy; and (4) ability to provide faecal samples. In total, 400 patients will be enrolled prospectively. Enrolment will begin in 2021, and the final analyses will be completed by 2024.Ethics and disseminationThe study protocol was approved by the institutional review board of each participating centre in 2021 (Kyushu Cancer Center, IRB approved No. 2021-13, 8 June 2021 and Kyushu Medical Center, IRB approved No. 21-076, 31 August 2021). Study results will be disseminated through peer-reviewed journals and national and international conferences.Trial registration numberUMIN000046428.
Oral glucose tolerance testing as a complement to fasting plasma glucose in screening for type 2 diabetes: population-based cross-sectional analyses of 146 000 health examinations in Västerbotten, Sweden
Authors: Rosén Anna , Otten Julia , Stomby Andreas , Vallin Simon , Wennberg Patrik , Brunström Mattias 
Published: June 2022

ObjectiveTo assess the effect of adding an oral glucose tolerance test (OGTT) to fasting plasma glucose (FPG) in terms of detection of type 2 diabetes (T2D) and impaired glucose tolerance (IGT).DesignRetrospective analysis of serial cross-sectional screening study.SettingPopulation-based health examinations within primary care in Västerbotten County, Sweden.ParticipantsIndividuals aged 40- 50 and 60 years with participation from 1985 to 2017. Those with previously diagnosed diabetes and FPG≥7 mmol/L were excluded.Primary and secondary outcome measuresPrevalence of hyperglycaemia on the OGTT (IGT and T2D defined as 2-hour postload capillary plasma glucose of 8.9–12.1 mmol/L and ≥12.2 mmol/L, respectively). Analyses were further stratified by age, sex and risk factor burden to identify groups at high or low risk of IGT and T2D on testing. The numbers needed to screen (NNS) to prevent one case of T2D through detection and treatment of IGT was estimated, combining prevalence numbers with average progression rates and intervention effects from previous meta-analyses.ResultsThe prevalence of IGT ranged from 0.9% (95% CI 0.7% to 1.1%) to 29.6% (95% CI 27.4% to 31.7%), and the prevalence of T2D ranged from 0.06% (95% CI 0.02% to 0.11%) to 7.0% (95% CI 5.9% to 8.3%), depending strongly on age, sex and risk factor burden. The estimated NNS to prevent one case of T2D through detection and lifestyle treatment of IGT ranged from 1332 among 40-year-old men without risk factors, to 39 among 60-year-old women with all risk factors combined.ConclusionsThe prevalence of hyperglycaemia on OGTT is highly dependent on age, sex and risk factor burden; OGTT should be applied selectively to high-risk groups to avoid unnecessary testing in the general population.