bluuebunny/crossref_metadata_2025_split huggingface dataset:
Initial implementation of PrEP in Zambia: health policy development and service delivery scale-up
Authors: Claassen Cassidy W. , Mumba Daliso , Njelesani Mwansa , Nyimbili Derrick , Mwango Linah K , Mwitumwa Mundia , Mubanga Ellen , Mulenga Lloyd B. , Chisenga Tina , Nichols Brooke E. , Hendrickson Cheryl , Chitembo Lastone , Okuku Jackson , O'Bra Heidi 
Published: July 2021

IntroductionDaily pre-exposure prophylaxis (PrEP) for HIV prevention is highly effective, but not yet widely deployed in sub-Saharan Africa. We describe how Zambia developed PrEP health policy and then successfully implemented national PrEP service delivery.Policy developmentZambia introduced PrEP as a key strategy for HIV prevention in 2016, and established a National PrEP Task Force to lead policy advocacy and development. The Task Force was composed of government representatives, regulatory agencies, international donors, implementation partners and civil society organisations. Following an implementation pilot, PrEP was rolled out nationally using risk-based criteria alongside a national HIV prevention campaign.National Scale-upIn the first year of implementation, ending September 2018, 3626 persons initiated PrEP. By September 2019, the number of people starting PrEP increased by over sixfold to 23 327 persons at 728 sites across all ten Zambian provinces. In the first 2 years, 26 953 clients initiated PrEP in Zambia, of whom 31% were from key and priority populations. Continuation remains low at 25% and 11% at 6 and 12 months, respectively.Lessons learntRisk-based criteria for PrEP ensures access to those most in need of HIV prevention. Healthcare worker training in PrEP service delivery and health needs of key and priority populations is crucial. PrEP expansion into primary healthcare clinics and community education is required to reach full potential. Additional work is needed to understand and address low PrEP continuation. Finally, a task force of key stakeholders can rapidly develop and implement health policy, which may serve as a model for countries seeking to implement PrEP.
Health-related quality of life in patients with implantable cardioverter defibrillators in Sweden: a cross-sectional observational trial
Authors: Magnusson Peter , Mattsson Gustav , Wallhagen Marita , Karlsson Jan 
Published: July 2021

ObjectivesDecisions regarding implantable cardioverter defibrillators (ICDs) must consider information about presumed health-related quality of life (HRQL). The purpose of the study was to assess HRQL in patients with ICD and compare it to a Swedish age-matched and sex-matched population.DesignCross-sectional observational trial.SettingSwedish ICD cohort.InterventionsShort form 36 (SF-36) questionnaires from ICD recipients implanted 2007–2017 (response rate 77.2%) were analysed using Mann-Whitney U test and effect size (ES).ResultsIn total, 223 patients (mean age 71.1±9.7 years, 82.1% men) were included. In most SF-36 domains (physical functioning (PF), role physical, general health (GH), vitality, social functioning and mental health), the score for patients with ICD was significantly lower (ES range 0.23–0.41, ie, small difference) than norms, except for bodily pain and role emotional. Both the physical component summary (PCS) and the mental component summary (MCS) scores had ES=0.31. Men and women had similar scores. Primary and secondary prevention patients scored similarly, except for worse GH in primary prevention (p=0.016, ES=0.35). Atrial fibrillation was associated with worse PF (ES=0.41) and PCS (ES=0.38). Appropriate therapy, inappropriate shock or complications requiring surgery were not associated with lower scores in any domain. In primary prevention due to ischaemic versus non-ischaemic cardiomyopathy, no domain was significantly different. PCS decreased with higher age strata (p=0.002) in contrast to MCS (p=0.986).ConclusionsPatients with ICDs have lower physical and mental HRQL than age-matched and sex-matched norms; however, the ESs are small. HRQL is similar regardless of sex, primary/secondary prevention indication, appropriate therapy, inappropriate shock or complications, but decreases with advancing age.
Mixed-methods approach to develop an agreed concept on patient relevance: study protocol for the ‘PRO patients study’
Authors: Kersting Christine , Barzel Anne , Mortsiefer Achim 
Published: July 2021

IntroductionWith respect to patient-centred care and shared decision-making, measuring care effects based on outcomes relevant to patients is becoming increasingly important. Recently, a scoping review of the international literature revealed a wide range of supposedly patient-relevant outcomes and found that there is neither a sound definition of patient relevance nor a consistent set of outcomes relevant to patients. To close this gap, this study aims to develop an agreed concept on patient relevance including a set of outcomes relevant to patients irrespective of diseases, which grades outcomes according to their importance.Methods and analysisThis prospective mixed-methods study will integrate the perspectives of patients across diseases, healthcare professionals and researchers. The consensus process will consist of four phases. Based on the results of the recent scoping review, a patient survey will be conducted first, followed by a multiprofessional group discussion. Finally, a two-round online Delphi approach based on data from the previous phases will be applied to agree on a concept.Ethics and disseminationEthics approval for the study was granted on 26 August 2020 by the Ethics Commission of Witten/Herdecke University (reference number: 156/2020). In the long run, the implementation of an agreed concept on patient relevance will help improve the comparability of study results regarding the patient benefit and thereby strengthen the role of patients in the decision-making process. Also, the experiences regarding grading outcomes according to importance will help to develop a method on how to individualise clinical trial outcomes according to each patient’s individual specifics and priorities in order to more adequately represent the patient perspective in clinical research.Trial registration numberCore Outcome Measures in Effectiveness Trials Initiative (registration number: 1685).
Mixed methods study protocol to explore acculturation, lifestyles and health of immigrants from the Community of Portuguese-Speaking Countries in two Iberian contexts: how to face uncertainties amidst the COVID-19 pandemic
Authors: Alves Daniela , Craveiro Isabel , Basabe Nekane , Gonçalves Luzia 
Published: July 2021

IntroductionStudies which focus on the process of acculturation in the lifestyles, nutritional status and health of immigrants from the Community of Portuguese-Speaking Countries (CPLP) in the Iberian Peninsula are still scarce. This study aims to explore the influence of the acculturation process and dietary acculturation on the lifestyle and nutritional and health status of CPLP immigrants in Portugal and Spain, focusing on two Iberian contexts: Lisbon Metropolitan Area and the Basque Country.Methods and analysisA mixed methods sequential explanatory design, combining cross-sectional studies and semistructured interviews. Official data will also be analysed. Primary data will be collected through a questionnaire and assessment of nutritional status and body composition. The estimated samples sizes are 1061 adults (≥18 years old) in the Lisbon Metropolitan Area and 573 in the Basque Country. Time-location sampling will be used for the quantitative component and non-probabilistic sampling for the qualitative component. If safety conditions are not guaranteed due to the COVID-19 pandemic, online studies will be conducted. The semistructured interviews will complement the questionnaire data and extend knowledge about the process of acculturation of CPLP immigrants and their relationship with eating habits and physical activity. Thematic analysis will be used for qualitative data. Triangulation of data derived from different methods will be carried out. An integrative approach will be used to address potential discrepancies in findings and limitations inherent to the study design. As inter-method discrepancies may occur, triangulation protocol will be used, elaborating a ‘convergence coding matrix’ to display findings emerging from each component of the study.Ethics and disseminationEthical approval was obtained through the IHMT Ethics Council (Doc No 20/2020), Portugal, and it was submitted to the Ethics Committee of the UPV/EHU (Doc No under revision), Spain.
Impact of duration of antibiotic prophylaxis on rates of surgical site infection (SSI) in patients undergoing mastectomy without immediate reconstruction, comparing a single prophylactic dose versus continued antibiotic prophylaxis postoperatively: a multicentre, double-blinded randomised control trial protocol
Authors: Sattar Abida K , Zahid Nida , Shahzad Hania , Soomro Rufina , Saleem Omema , Mahmood Syed Faisal 
Published: July 2021

IntroductionIn breast surgeries, prophylactic antibiotics given before the surgical incision as per Joint Commission Surgical Care Improvement Project guidelines have been shown to decrease the rate of postoperative infections. There is, however, no clear consensus on postoperative antibiotic prophylaxis in patients undergoing mastectomy with indwelling drains. This trial protocol proposes to study the difference in rates of surgical site infection (SSI) with or without continuation of postoperative antibiotics in patients undergoing mastectomy without immediate reconstruction and with indwelling drains.Methods and analysisIn this multicentre, double-blinded clinical trial, all patients undergoing mastectomy (without immediate reconstruction) will receive a single prophylactic dose of preoperative antibiotics at induction of anaesthesia and will then get randomised to either continue antibiotic prophylaxis or a placebo postoperatively, for the duration of indwelling drains. The primary and secondary outcomes will be development of an SSI and antibiotic-associated adverse effects, respectively. Data will be collected through a standard questionnaire by wound assessors. Intention-to-treat analysis will be carried out using STATA V.12. For categorical variables, frequencies and percentages will be assessed by χ2test/Fisher’s exact test as appropriate. The quantitative variables will be computed by their mean±SD or median (IQR) and will be assessed by independent t-test/Mann-Whitney test as appropriate. Unadjusted and adjusted relative risk with their 95% CI will be reported using Cox proportional regression. A p value of <0.05 will be considered statistically significant.Ethics and disseminationEthical approval has been obtained from each site’s Ethical Review Board. The study background and procedure will be explained to the study participants and informed consent will be obtained. Participation in the study is voluntary. All data will be deidentified and kept confidential. The study findings will be published in scientific media and authorship guidelines of International Committee of Medical Journal Editors will be followed.Trial registration numberNCT04577846. (patient recruitment)
Ethnicity and COVID-19 outcomes among healthcare workers in the UK: UK-REACH ethico-legal research, qualitative research on healthcare workers’ experiences and stakeholder engagement protocol
Authors: Gogoi Mayuri , Reed-Berendt Ruby , Al-Oraibi Amani , Hassan Osama , Wobi Fatimah , Gupta Amit , Abubakar Ibrahim , Dove Edward , Nellums Laura B , Pareek Manish 
Published: July 2021

IntroductionAs the world continues to grapple with the COVID-19 pandemic, emerging evidence suggests that individuals from ethnic minority backgrounds may be disproportionately affected. The United Kingdom Research study into Ethnicity And COVID-19 outcomes in Healthcare workers (UK-REACH) project has been initiated to generate rapid evidence on whether and why ethnicity affects COVID-19 diagnosis and clinical outcomes in healthcare workers (HCWs) in the UK, through five interlinked work packages/work streams, three of which form the basis of this protocol. The ethico-legal work (Work Package 3) aims to understand and address legal, ethical and acceptability issues around big data research; the HCWs" experiences study (Work Package 4) explores their work and personal experiences, perceptions of risk, support and coping mechanisms; the stakeholder engagement work (Work Package 5) aims to provide feedback and support with the formulation and dissemination of the project recommendations.Methods and analysisWork Package 3 has two different research strands: (A) desk-based doctrinal research; and (B) empirical qualitative research with key opinion leaders. For the empirical research, in-depth interviews will be conducted digitally and recorded with participants’ permission. Recordings will be transcribed, coded and analysed using thematic analysis. In Work Package 4, online in-depth interviews and focus groups will be conducted with approximately 150 HCWs, from across the UK, and these will be recorded with participants’ consent. The recordings will be transcribed and coded and data will be analysed using thematic analysis. Work Package 5 will achieve its objectives through regular group meetings and in-group discussions.Ethics and disseminationEthical approval has been received from the London-Brighton & Sussex Research Ethics Committee of the Health Research Authority (Ref No 20/HRA/4718). Results of the study will be published in open-access journals, and disseminated through conference presentations, project website, stakeholder organisations, media and scientific advisory groups.Trial registration numberISRCTN11811602.
Mechanical bowel preparation and oral antibiotics versus mechanical bowel preparation only prior rectal surgery (MOBILE2): a multicentre, double-blinded, randomised controlled trial—study protocol
Authors: Koskenvuo Laura , Lunkka Pipsa , Varpe Pirita , Hyöty Marja , Satokari Reetta , Haapamäki Carola , Lepistö Anna , Sallinen Ville 
Published: July 2021

IntroductionMechanical bowel preparation (MBP) prior to rectal surgery is widely used. Based on retrospective data many guidelines recommend mechanical and oral antibiotic bowel preparation (MOABP) to reduce postoperative complications and specifically surgical site infections (SSIs). The primary aim of this study is to examine whether MOABP reduces complications of rectal surgery.Methods and analysisThe MOBILE2 (Mechanical Bowel Preparation and Oral Antibiotics vs Mechanical Bowel Preparation Only Prior Rectal Surgery) trial is a multicentre, double-blinded, parallel group, superiority, randomised controlled trial comparing MOABP to MBP among patients scheduled for rectal surgery with colorectal or coloanal anastomosis. The patients randomised to the MOABP group receive 1 g neomycin and 1 g metronidazole two times on a day prior to surgery and patients randomised to the MBP group receive identical placebo. Based on power calculations, 604 patients will be enrolled in the study. The primary outcome is Comprehensive Complication Index within 30 days after surgery. Secondary outcomes are SSIs within 30 days after surgery, the number and classification of anastomosis dehiscences, the length of hospital stay, mortality within 90 days after surgery and the number of patients who received adjuvant treatment if needed. Tertiary outcomes are overall survival, disease-specific survival, recurrence-free survival and difference in quality-of-life before and 1 year after surgery. In addition, the microbiota differences in colon mucosa are analysed.Ethics and disseminationThe Ethics Committee of Helsinki University Hospital approved the study. The findings will be disseminated in peer-reviewed academic journals.Trial registration numberNCT04281667.
How do children and adolescents experience healthcare professionals? Scoping review and interpretive synthesis
Authors: Davison Gail , Kelly Martina Ann , Conn Richard , Thompson Andrew , Dornan Tim 
Published: July 2021

ObjectiveExplore children’s and adolescents’ (CADs’) lived experiences of healthcare professionals (HCPs).DesignScoping review methodology provided a six-step framework to, first, identify and organise existing evidence. Interpretive phenomenology provided methodological principles for, second, an interpretive synthesis of the life worlds of CADs receiving healthcare, as represented by verbatim accounts of their experiences.Data sourcesFive key databases (Ovid Medline, Embase, Scopus, Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus, and Web of Science), from inception through to January 2019, reference lists, and opportunistically identified publications.Eligibility criteriaResearch articles containing direct first-person quotations by CADs (aged 0–18 years inclusive) describing how they experienced HCPs.Data extraction and synthesisTabulation of study characteristics, contextual information, and verbatim extraction of all ‘relevant’ (as defined above) direct quotations. Analysis of basic scope of the evidence base. The research team worked reflexively and collaboratively to interpret the qualitative data and construct a synthesis of children’s experiences. To consolidate and elaborate the interpretation, we held two focus groups with inpatient CADs in a children’s hospital.Results669 quotations from 99 studies described CADs’ experiences of HCPs. Favourable experiences were of forming trusting relationships and being involved in healthcare discussions and decisions; less favourable experiences were of not relating to or being unable to trust HCPs and/or being excluded from conversations about them. HCPs fostered trusting relationships by being personable, wise, sincere and relatable. HCPs made CADs feel involved by including them in conversations, explaining medical information, and listening to CADs’ wider needs and preferences.ConclusionThese findings strengthen the case for making CADs partners in healthcare despite their youth. We propose that a criterion for high-quality child-centred healthcare should be that HCPs communicate in ways that engender trust and involvement.
Scoping review of balanced scorecards for use in healthcare settings: development and implementation
Authors: Bohm Victoria , Lacaille Diane , Spencer Nicole , Barber Claire EH 
Published: July 2021

ObjectiveBalanced scorecards (BSCs) were developed in the early 1990s in corporate settings as a strategic performance management tool that emphasised measurement from multiple perspectives. Since their introduction, BSCs have been adapted for a variety of industries, including to healthcare settings. The aim of this scoping review was to describe the application of BSCs in healthcare.MethodsMedline, Embase and CINHAL databases were searched using keywords and medical subject headings for ‘balanced scorecard’ and related terms from 1992 to 17/04/2020. Title and abstract screening and full text review were conducted in duplicate by two reviewers. Studies describing the development and/or implementation of a BSC in a healthcare setting were included. Data were abstracted using pilot-tested forms and reviewed for key themes and findings.Results8129 records were identified and 841 underwent a full text review. 87 articles were included. Over 26 countries were represented and the majority of BSCs were applied at a local level (54%) in hospital settings (41%). While almost all discussed Kaplan and Norton’s original BSC (97%), only 69% described alignment with a strategic plan. Patients/family members were rarely involved in development teams (3%) which typically were comprised of senior healthcare leaders/administrators. Only 21% of BSCs included perspectives using identical formatting to the original BSC description. Lessons learnt during development addressed three main themes: scorecard design, stakeholder engagement and feasibility.ConclusionsBSC frameworks have been used in various healthcare settings but frequently undergo adaptation from the original description in order to suit a specific healthcare context. Future BSCs should aim to include patients/families to promote patient-centred healthcare systems. Considering the heterogeneity evident in development approaches, methodological guidance in this area is warranted.
Evaluation of Pregnancy Outcomes of Vitrified-Warmed Blastocyst Transfer before and after Endometrial Receptivity Analysis in Identical Patients with Recurrent Implantation Failure
Authors: Kasahara Yuta , Hashimoto Tomoko , Yokomizo Ryo , Takeshige Yuya , Yoshinaga Koki , Toya Mayumi , Igarashi Hideki , Kishi Hiroshi , Kyono Koichi 
Published: July 2021

Background: The clinical value of personalized embryo transfer (pET) guided by the endometrial receptivity analysis (ERA) tests for recurrent implantation failure (RIF) cases is still unclear. The aim of this study is to clarify the efficacy of ERA leading to personalization of the day of embryo transfer (ET) in RIF patients. Methods: A retrospective study was performed for 94 patients with RIF who underwent ERA between July 2015 and December 2019. Pregnancy outcomes in a previous vitrified-warmed blastocyst transfer (previous VBT) and a personalized vitrified-warmed blastocyst transfer (pVBT) in identical patients were compared. The details of each pVBT were further analyzed between patients in a non-displaced group, which indicated “receptive” cases in ERA results and those who were in the displaced group, which indicated “non-receptive” cases. Results: When the pregnancy rate, both per patient and per transfer cycle, of previous VBT and pVBT were compared, a significant increase in pVBT was observed between the two methods (5.3% vs. 62.8%, 4.4% vs. 47.9%, respectively). The pregnancy rates, implantation rates, and clinical pregnancy rates of the first pVBT were significantly higher in the displaced group than the non-displaced group. The cumulative ongoing pregnancy rate of the displaced group tended to be higher compared to that of the non-displaced group in the first pVBT, although the difference was not statistically significant (51.0% vs. 31.1%, [Formula: see text]). Conclusions: Our study demonstrates that pVBT guided by ERA tests may improve pregnancy outcomes in RIF patients whose window of implantation (WOI) is displaced, and its effect may be more pronounced at the first pVBT. The displacement of WOI may be considered to be one of the causes of RIF, and its adjustment may contribute to the improvement of pregnancy outcomes in RIF patients.