bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prevention Of Breast and Endometrial cancer using Total Diet Replacement (PROBE-TDR) trial: protocol for a randomised controlled trial
Authors: Clarke Helen , Harvie Michelle , Lombardelli Cheryl , Krizak Suzanne , Sellers Katharine , Harrison Hannah , Lim Yit Y , Parkin Caroline , Patel Shruthi , Issa Basil G , Maxwell Anthony J , Wisely Julie , Belcher John , Clarke Robert , Howell Anthony , Crosbie Emma J , Howell Sacha J 
Published: July 2022

IntroductionObesity and overweight are strong potentially modifiable risk factors for postmenopausal breast and endometrial cancer. Bariatric surgery can achieve considerable weight loss and risk reduction of weight-related cancer but is unlikely to be a feasible cancer prevention strategy. Total diet replacement (TDR) can also lead to significant weight reduction. This study aims to examine the cellular and molecular changes in breast and endometrial tissue in high-risk women following TDR-induced weight loss, as well as longer-term adherence to a 12-month TDR weight loss intervention.Methods and analysisPROBE-TDR (PRevention Of Breast and Endometrial cancer using Total Diet Replacement) is a prospective, non-blinded, randomised controlled trial of 47 women at increased risk of breast and/or endometrial cancer. Randomisation is 2:1 to either an immediate 12-month TDR weight loss programme (n=31) or delayed dietary intervention (control) (n=16). The TDR programme includes an initial 12-week period of TDR (850 kcal/day) followed by a 40-week food-based diet, based on the nutritional principles of a Mediterranean diet, as either continued weight loss (~1500 kcal/day) or weight loss maintenance (~2000 kcal/day). Menstrual phase-matched biopsies of the breast and endometrium will be assessed at baseline and at the end of the 12-week TDR in the immediate diet group, compared with women randomised to the control group following their usual diet. The trial will also assess longer-term adherence and weight loss success across the 12-month programme in both the immediate and control groups.Ethics and disseminationApproval for this study has been obtained from the Health Research Authority and Health and Care Research Wales (approval 20/NW/0095). Results will be published in peer-reviewed journals, presented at conferences and shared with trial participants.Trial registration numberInternational Standard Randomised Controlled Trial Number Registry (ISRCTN15358157).
Views of nurses and other healthcare workers on interventions to reduce disrespectful maternity care in rural health facilities in Kilifi and Kisii counties, Kenya: analysis of a qualitative interview study
Authors: Lusambili Adelaide M , Obure Jerim , Wisofschi Stefania , Nyaga Lucy , Mulama Kennedy , Temmerman Marleen 
Published: July 2022

ObjectiveThere is an abundance of evidence illuminating the factors that contribute to disrespectful maternity care in sub-Saharan Africa. However, there is limited documented evidence on how some of the key influences on the mistreatment of women could be addressed. We aimed to document the perspectives of nurses and other healthcare workers on existing and potential strategies embedded at the health facility level to promote respectful delivery of healthcare for women during delivery and on what interventions are needed to promote respectful and equitable treatment of women receiving maternity care in rural Kenya.Design, setting and participantsWe analysed relevant data from a qualitative study based on in-depth interviews with 24 healthcare workers conducted between January and March 2020, at health facilities in rural Kilifi and Kisii counties, Kenya. The facilities had participated in a project (AQCESS) to reduce maternal and child mortality and morbidity by improving the availability and the use of essential reproductive maternal and neonatal child health services. The participants were mostly nurses but included five non-nurse healthcare workers. We analysed data using NVivo V.12, guided by a reflective thematic analysis approach.ResultsHealthcare workers identified four interconnected areas that were associated with improving respectful delivery of care to women and their newborns. These include continuous training on the components of respectful maternity care through mentorships, seminars and organised training; gender-responsive services and workspaces; improved staffing levels; and adequate equipment and supplies for care.ConclusionsThese findings demonstrate some of the solutions, from the perspectives of healthcare workers, that could be implemented to improve the care that women receive during pregnancy, labour and delivery. The issues raised by healthcare workers are common in sub-Saharan African countries, indicating the need to create awareness at the policy level to highlight the challenges identified, potential solutions, and application or implementation in different contexts.
Estradiol and progesterone levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer cycle: a randomised controlled trial protocol
Authors: Mørch Nina Freiesleben , Lauritsen Mette Petri , Svendsen Pernille Fog 
Published: July 2022

IntroductionFrozen embryo transfer is being increasingly used for assisted reproductive therapy and offers similar pregnancy rates as treatment with fresh embryo transfer. In women with regular menstrual cycles, transfer of a frozen thawed blastocyst can be performed in either natural cycle or substituted cycle. Anovulatory women can only be offered a substituted or a stimulated cycle. Knowledge on fetal exposure to estradiol in early pregnancy is very limited, but studies on mice and rats have shown hormonal and metabolic disturbances in cubs born from estradiol-exposed mothers. We aim to investigate serum estradiol and progesterone levels in women who conceived after natural, estradiol and progesterone, or gonadotrophin stimulated frozen embryo transfer.Methods and analysisThe study is an open-label, randomised controlled trial with normo-ovulatory women being randomised to natural cycle or estradiol and progesterone substitution and anovulatory women being randomised to estradiol and progesterone substitution or gonadotrophin stimulation. Serum estradiol and progesterone will be measured every 2 weeks from cycle days 2–3 until gestational age 9+6. Serum levels will be compared according to treatment regimens and cycle length. Furthermore, obstetric outcomes (live birth rates, birth weight, gestational age at birth, complications and malformations) and a possible association with serum estradiol and progesterone levels will be evaluated.Ethics and disseminationThe three treatment regimens are all standard treatments and are comparable with regard to pregnancy rates. Patients will be following routine treatments and thus discomforts are limited to routine transvaginal ultrasound scans and additional blood testing. The study is approved by the Scientific Ethical Committee of the Capital Region of Denmark and the Danish Medicines Agency. The study will be carried out in accordance with the Declaration of Helsinki and monitored by a good clinical practice unit. Positive, negative and inconclusive findings will be published in international peer-reviewed journals.Trial registration numberNCT04997525, 2020-001218-39.
Experiences and practices of people categorised as being ‘at risk’ based on age during the COVID-19 pandemic: a qualitative study in the UK and Germany
Authors: Wabnitz Katharina , Drössler Stephanie , Mayhew Susannah 
Published: July 2022

ObjectivesThe aim of this study was to comparatively explore the social representations of risk in individuals categorised ‘at risk’ based on age during the COVID-19 pandemic. What characterised their sense-making of being at risk and what effects did this have on their lives, behaviour and identities?DesignInterview-based qualitative study.SettingUK and Germany, July–August 2020.Participants11 individuals from Germany and eight from the UK were recruited purposively. Inclusion criteria: to be at risk for a severe course of COVID-19 due to age ≥50 years (Germany) and ≥70 years (UK) based on official communication by the respective national public health authority.Exclusion criteria: any form of dementia, pre-existing mental health issues, congenital physical or mental disabilities, being resident in a care home, having a personal relationship to the principal investigator.MethodsSemistructured in-depth interviews were conducted remotely. Reflexive thematic analysis was carried out to inductively develop themes illustrative of shared patterns of meaning across the whole data set.ResultsThree main themes are reported. ‘Establishing safe spaces’ (perceiving safety and risk in relation to others and implementing prevention measures to maintain safe spaces); ‘Assessing and responding to risk’ (risk as danger relative to others and risk management as a responsibility of the individual) and ‘Considerations on the value of a life’ (in relation to quality of life, length of life and capacity to contribute to society). Cross cutting all of these, is the notion of relational assessment.ConclusionsThe experience of risk and related behaviour is contingent on the individuals’ mindset, body and the setting (geographical, political and sociocultural) one is positioned in. Negotiating identities is an inevitable process accompanying sense-making of (new) risks. Public health practice and communication could benefit from at least being informed by and at best being based on the meanings and representations of those whose health and well-being we want to ensure.
Early prediction of in-hospital mortality in patients with congestive heart failure in intensive care unit: a retrospective observational cohort study
Authors: Han Didi , Xu Fengshuo , Zhang Luming , Yang Rui , Zheng Shuai , Huang Tao , Yin Haiyan , Lyu Jun 
Published: July 2022

ObjectiveCongestive heart failure (CHF) is a clinical syndrome in which the heart disease progresses to a severe stage. Early diagnosis and risk assessment of death of patients with CHF are critical to prognosis and treatment. The purpose of this study was to establish a nomogram that predicts the in-hospital death of patients with CHF in the intensive care unit (ICU).DesignA retrospective observational cohort study.Setting and participantsData for the study were from 30 411 patients with CHF in the Medical Information Mart for Intensive Care database and the eICU Collaborative Research Database (eICU-CRD).Primary outcomeIn-hospital mortality.MethodsUnivariate logistic regression analysis was used to select risk factors associated with in-hospital mortality of patients with CHF, and multivariate logistic regression was used to build the prediction model. Discrimination, calibration and clinical validity of the model were evaluated by AUC, calibration curve, Hosmer-Lemeshow χ2 test and decision curve analysis, respectively. Finally, data from 15 503 patients with CHF in the multicentre eICU-CRD were used for external validation of the established nomogram.ResultsThe inclusion criteria were met by 15 983 subjects, whose in-hospital mortality rate was 12.4%. Multivariate analysis determined that the independent risk factors were age, race, norepinephrine, dopamine, phenylephrine, vasopressin, mechanical ventilation, intubation, hepatic failure (HepF), heart rate, respiratory rate, temperature, systolic blood pressure (SBP), anion gap (AG), blood urea nitrogen (BUN), creatinine, chloride, mean corpuscular volume (MCV), red blood cell distribution width (RDW) and white cell count (WCC). The C-index of the nomogram (0.767, 95% CI 0.759 to 0.779) was superior to that of the traditional Sequential Organ Failure Assessment, Acute Physiology Score III and Get With The Guidelines Heart Failure scores, indicating its discrimination power. Calibration plots demonstrated that the predicted results are in good agreement with the observed results. The decision curves of the derivation and validation sets both had net benefits.ConclusionThe 20 independent risk factors for in-hospital mortality of patients with CHF were age, race, norepinephrine, dopamine, phenylephrine, vasopressin, mechanical ventilation, intubation, HepF, heart rate, respiratory rate, temperature, SBP, AG, BUN, creatinine, chloride, MCV, RDW and WCC. The nomogram, which included these factors, accurately predicted the in-hospital mortality of patients with CHF. The novel nomogram has the potential for use in clinical practice as a tool to predict and assess mortality of patients with CHF in the ICU.
Vaginal hysterectomy versus vaginal assisted NOTES hysterectomy (VANH): a protocol for a randomised controlled trial
Authors: Bekkers Ilse , Hoen Lynn , van Vliet Huib A A M , Smeets Nicol A C , Damoiseaux Anne , Kimman Merel , Wassen Martine M L H 
Published: July 2022

IntroductionNatural Orifice Transluminal Endoscopic Surgery is a minimal invasive technique using natural body orifices like the vagina. Benefits of a vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less blood loss, shorter surgery time and it allows more women to undergo a hysterectomy in a day-care setting compared with the total laparoscopic hysterectomy. Trials comparing vaginal hysterectomy (VH) and VANH are lacking. The aim of this study is to compare hysterectomy by VANH versus VH for same-day discharge (SDD), complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Methods and analysisThe study is a single-blinded, multicentre, randomised controlled trial. Eligible women with benign indication for hysterectomy will be randomly allocated to the VH (control) group or the VANH (intervention) group. The primary outcome is SDD. We calculated a sample size of 124 women assuming 27% SDD difference with an alpha of 0.05 and power of 0.8. A total of 83 patients will be included in the VANH-group and 41 patients in the VH-group, using an enrolment ratio of 2:1. Secondary outcomes are; surgery-related complications, surgical outcomes, postoperative recovery, quality of life, costs and cost-effectiveness.Ethics and disseminationThe study was approved on 27 May 2021 by the Ethics Committee of the Zuyderland Medical Centre Heerlen. The first patient was randomised on 8 July 2021. The last participant randomised should be treated before 31 December 2022. The results will be presented in peer-reviewed journals and at scientific meetings within 4 years after starting recruitment.Trial registration numberNCT04886791.
Reducing dementia-related stigma and discrimination among community health workers in Brazil: protocol for a randomised controlled feasibility trial
Authors: Oliveira Déborah , Godoy Carolina , da Mata Fabiana A F , Mateus Elaine , Franzon Ana Carolina Arruda , Farina Nicolas , Evans-Lacko Sara , Ferri Cleusa P 
Published: July 2022

IntroductionStigma and discrimination among healthcare workers can hinder diagnosis and the provision of appropriate care in dementia. This study is aimed at developing, delivering and evaluating the feasibility of a group antistigma intervention to improve knowledge, attitudes and behaviours in relation to people living with dementia among community health workers (CHWs).Methods and analysisThis will be a randomised controlled feasibility trial conducted with 150 CHWs from 14 primary care units (PCUs) in São Paulo, Brazil. PCUs will be randomly allocated (1:1) in two parallel groups—experimental group or control group. Participants from PCUs allocated to the experimental group will receive a 3-day group intervention involving audio-visual and printed materials as well as elements of social contact. The control group will keep their usual routine. Knowledge, attitude and intended behaviour stigma-based outcomes will be assessed at baseline and at follow-up (30 days after intervention) to both groups, with additional questions on feasibility for the experimental group at follow-up. Around 10–15 participants will take part in follow-up semistructured interviews to further explore feasibility. Quantitative analyses will follow an ‘intention to treat’ approach. Qualitative data will be analysed using content analysis.Ethics and disseminationThis study was approved by the National Commission for Ethics in Research in Brazil (n. 5.510.113). Every participant will sign a consent form. Results will be disseminated through academic journals and events related to dementia. The intervention materials will be made available online.
What is the evidence for efficacy of advance care planning in improving patient outcomes? A systematic review of randomised controlled trials
Authors: Malhotra Chetna , Shafiq Mahham , Batcagan-Abueg Ada Portia Macarubbo 
Published: July 2022

ObjectivesTo conduct an up-to-date systematic review of all randomised controlled trials assessing efficacy of advance care planning (ACP) in improving patient outcomes, healthcare use/costs and documentation.DesignNarrative synthesis conducted for randomised controlled trials. We searched electronic databases (MEDLINE/PubMed, Embase and Cochrane databases) for English-language randomised or cluster randomised controlled trials on 11 May 2020 and updated it on 12 May 2021 using the same search strategy. Two reviewers independently extracted data and assessed methodological quality. Disagreements were resolved by consensus or a third reviewer.ResultsWe reviewed 132 eligible trials published between 1992 and May 2021; 64% were high-quality. We categorised study outcomes as patient (distal and proximal), healthcare use and process outcomes. There was mixed evidence that ACP interventions improved distal patient outcomes including end-of-life care consistent with preferences (25%; 3/12 with improvement), quality of life (0/14 studies), mental health (21%; 4/19) and home deaths (25%; 1/4), or that it reduced healthcare use/costs (18%; 4/22 studies). However, we found more consistent evidence that ACP interventions improve proximal patient outcomes including quality of patient–physician communication (68%; 13/19), preference for comfort care (70%; 16/23), decisional conflict (64%; 9/14) and patient-caregiver congruence in preference (82%; 18/22) and that it improved ACP documentation (a process outcome; 63%; 34/54).ConclusionThis review provides the most comprehensive evidence to date regarding the efficacy of ACP on key patient outcomes and healthcare use/costs. Findings suggest a need to rethink the main purpose and outcomes of ACP.PROSPERO registration numberCRD42020184080.
Development and validation of risk models to predict chronic kidney disease among people living with HIV: protocol for a systematic review
Authors: Odubela Oluwatosin Olaseni , Odunukwe Nkiruka , Peer Nasheeta , Musa Adesola Z , Salako Babatunde L , Kengne A P 
Published: July 2022

IntroductionChronic kidney disease (CKD) is estimated to affect about 9.1% of the global population with a substantially increased risk of the condition (6.8%–17.2%) among people living with HIV (PLWH). This increased risk is attributed to HIV infection itself, antiretroviral therapy, coexisting viral infections, non-infectious comorbidities and traditional risk factors for CKD. Predictive models have been employed in the estimation of prevalent and incident CKD risk in both PLWH and the general population. A predictive model showing an individual’s risk of prevalent and/or progression to kidney failure is useful for initiating timely interventions that prevent further worsening of kidney function. This study will systematically review published prediction models developed and/or validated for prevalent and incident CKD in PLWH, describe their characteristics, compare performance and assess methodological quality and applicability.Methods and analysisStudies with predictive models of interest will be identified by searching MEDLINE, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Cochrane library and Scopus from inception to May 2022. Title and abstract screening, full-text review and data extraction will be completed independently by two reviewers. Using appropriate tools designed for predictive modelling investigations, the included papers will be rigorously assessed for bias and applicability. Extracted data will be presented in tables, so that published prediction models can be compared qualitatively. Quantitative data on the predictive performance of these models will be synthesised with meta-analyses if appropriate.Ethics and disseminationThe findings of the review will be disseminated in peer-reviewed journals and seminar presentations. Ethical approval is not required as this is a protocol for a systematic review.PROSPERO registration numberCRD42021279694.
Insight into Nigeria’s progress towards the universal coverage of reproductive, maternal, newborn and child health services: a secondary data analysis
Authors: Mafiana Joy James , Shen Xiping , Hu Wenping , Wang Xiaohui 
Published: July 2022

ObjectiveThis study investigated the progress towards the universal coverage of reproductive, maternal, newborn and child health (RMNCH) services in Nigeria after universal health coverage (UHC) adoption.DesignA descriptive observational approach was used based on secondary data analysis. Representative data generated from publicly accessible databases and reports were used to describe the coverage trend and estimate the absolute inequality. Analysis was conducted using Excel and the WHO’s Health Equity Assessment Toolkit software.SettingThe study setting is Nigeria.ParticipantsAggregated health service coverage data of women aged 15–49 years and children under 5 years of age.Outcome measuresThe outcome of interest is the level of coverage of RMNCH services in Nigeria and the difference in equity gaps among subgroups before and after UHC adoption.ResultsThe RMNCH index increased by 6.4% points with a difference of 33.7% points to attain the minimum 80.0% target. The widest inequality was by economic status with the difference ranging from 21.9% points (95% CI 10.1% to 33.8%) to 56.3% points (95% CI 51.5% to 61.2%), Absolute Concentration Index from 3.5% points (95% CI 1.6% to 5.5%) to 11.3% points (95% CI 10.4% to 12.2%), Slope Index of Inequality from 23.1% points (95% CI 11.9% to 34.2%) to 65.5% points (95% CI 62.6% to 68.5%) and population attributable risk from 9.3% points (95% CI 7.3% to 11.4%) to 31.2% points (95% CI 29.0% to 33.3%). Among the indicators, three doses of diphtheria–tetanus–toxoid–pertussis immunisation had the widest absolute inequality across the subgroups.ConclusionThe poor coverage of RMNCH services in Nigeria and persistent inequalities pinpoint the need to investigate further the country-level determinant of RMNCH service coverage. In addition, it emphasises the need to formulate effective policies focusing on marginalised groups and improving resource allocation to ensure sustainable service coverage.