bluuebunny/crossref_metadata_2025_split huggingface dataset:
EnDPoINT: protocol for an implementation research study to integrate a holistic package of physical health, mental health and psychosocial care for podoconiosis, lymphatic filariasis and leprosy into routine health services in Ethiopia
Authors: Semrau Maya , Ali Oumer , Deribe Kebede , Mengiste Asrat , Tesfaye Abraham , Kinfe Mersha , Bremner Stephen A , Hounsome Natalia , Kelly-Hope Louise A , MacGregor Hayley , Taddese Henock B , Banteyerga Hailom , HaileMariam Damen , Negussu Nebiyu , Fekadu Abebaw , Davey Gail 
Published: October 2020

IntroductionNeglected tropical diseases (NTDs) causing lower limb lymphoedema such as podoconiosis, lymphatic filariasis (LF) and leprosy are common in Ethiopia. Routine health services for morbidity management and disability prevention (MMDP) of lymphoedema caused by these conditions are still lacking, even though it imposes a huge burden on affected individuals and their communities in terms of physical and mental health, and psychosocial and economic outcomes. This calls for an integrated, holistic approach to MMDP across these three diseases.Methods and analysisThe ‘Excellence in Disability Prevention Integrated across NTDs’ (EnDPoINT) implementation research study aims to assess the integration and scale-up of a holistic package of care—including physical health, mental health and psychosocial care—into routine health services for people with lymphoedema caused by podoconiosis, LF and leprosy in selected districts in Awi zone in the North–West of Ethiopia. The study is being carried out over three phases using a wide range of mixed methodologies. Phase 1 involves the development of a comprehensive holistic care package and strategies for its integration into the routine health services across the three diseases, and to examine the factors that influence integration and the roles of key health system actors. Phase 2 involves a pilot study conducted in one subdistrict in Awi zone, to establish the care package’s adoption, feasibility, acceptability, fidelity, potential effectiveness, its readiness for scale-up, costs of the interventions and the suitability of the training and training materials. Phase 3 involves scale-up of the care package in three whole districts, as well as its evaluation in regard to coverage, implementation, clinical (physical health, mental health and psychosocial) and economic outcomes.Ethics and disseminationEthics approval for the study has been obtained in the UK and Ethiopia. The results will be disseminated through publications in scientific journals, conference presentations, policy briefs and workshops.
Couples-based approach to HIV prevention for transgender women and their partners: study protocol for a randomised controlled trial testing the efficacy of the ‘It Takes Two’ intervention
Authors: Gamarel Kristi E , Sevelius Jae M , Neilands Torsten B , Kaplan Rachel L , Johnson Mallory O , Nemoto Tooru , Darbes Lynae A , Operario Don 
Published: October 2020

IntroductionHIV transmission and acquisition risk among transgender women is particularly high in the context of primary partnerships. This project extends a previous pilot couples-focused HIV intervention programme, which was shown to be feasible, acceptable and promising in reducing sexual risk behaviour among transgender women and their partners. This randomised controlled trial (RCT) tests the efficacy of this culturally sensitive HIV prevention programme for HIV-serodiscordant and HIV-negative seroconcordant transgender women and their partners.Methods and analysisTo finalise the protocol for trial, we used qualitative methods to hone eligibility criteria, refine the intervention and control manuals, and name and brand the intervention (‘It Takes Two’). The RCT investigates the effects of the It Takes Two intervention on Composite Risk for HIV (CR-HIV) among 100 couples. CR-HIV is a binary indicator of couple HIV risk using validated measures of sexual behaviour, pre-exposure prophylaxis use among HIV-negative participants and viral suppression among participants living with HIV. Using a two-arm RCT, we will examine intervention effects on CR-HIV at 12-month follow-up comparing transgender women and their partners randomised to the intervention versus control (HIV prevention information only).Ethics and disseminationThis study has been reviewed and approved by the University of California, San Francisco (19-28624) and the University of Michigan (HUM00147690) Institutional Review Boards. Participants provide informed consent before taking part of the study activities. Results will be published in peer-reviewed journals and presented at scientific conferences. We will make our results available to the community of researchers and general public interested in transgender health to avoid unintentional duplication of research, as well as to others in the health and social services community, including LGBT community-based organisations, AIDS service organisations and other transgender-serving organisations. The full de-identified dataset and codebook will be shared at the University of Michigan Digital Repository.Trial registration numberNCT04067661.
Towards a multilevel governance framework on the implementation of patient rights in health facilities: a protocol for a systematic scoping review
Authors: Putturaj Meena , Van Belle Sara , Criel Bart , Engel Nora , Krumeich Anja , B Nagendrappa Prakash , Prashanth NS 
Published: October 2020

IntroductionPatient rights are “those rights that are attributed to a person seeking healthcare”. Patient rights have implications for quality of healthcare and acts as a key accountability tool. It can galvanise structural improvements in the health system and reinforces ethical healthcare. States are duty bound to respect, protect and promote patient rights. The rhetoric on patient rights is burgeoning across the globe. With changing modes of governance arrangements, a number of state and non-state actors and institutions at various levels play a role in the design and implementation of (patient rights) policies. However, there is limited understanding on the multilevel institutional mechanisms for patient rights implementation in health facilities. We attempt to fill this gap by analysing the available scholarship on patient rights through a critical interpretive synthesis approach in a systematic scoping review.MethodsThe review question is ‘how do the multilevel actors, institutional structures, processes interact and influence the patient rights implementation in healthcare facilities? How do they work at what level and in which contexts?” Three databases PubMed, LexisNexis and Web of Science will be systematically searched until 30th April 2020, for empirical and non-empirical literature in English from both lower middle-income countries and high-income countries. Targeted search will be performed in grey literature and through citation and reference tracking of key records. Using the critical interpretive synthesis approach, a multilevel governance framework on the implementation of patient rights in health facilities which is grounded in the data will be developed.Ethics and disseminationThe review uses published literature hence ethics approval is not required. The findings of the review will be published in a peer-reviewed journal.Registration numberPROSPERO 2020 CRD42020176939
Protocol description of the HOVON 141/VISION trial: a prospective, multicentre, randomised phase II trial of ibrutinib plus venetoclax in patients with creatinine clearance ≥30 mL/min who have relapsed or refractory chronic lymphocytic leukaemia (RR-CLL) with or without TP53 aberrations
Authors: Levin Mark-David , Kater Arnon , Mattsson Mattias , Kersting Sabina , Ranti Juha , Thi Tuyet Tran Hoa , Nasserinejad Kazem , Niemann Carsten Utoft 
Published: October 2020

IntroductionLiterature is scarce on the combination treatment of ibrutinib and venetoclax (IV) is scarce in relapsed or refractory chronic lymphocytic leukaemia (RR-CLL). Especially, the possibility of stopping ibrutinib in RR-CLL patients in deep remission is unclear.Methods and analysisIn the HOVON 141/VISION trial, patients with RR-CLL are treated with 12 cycles of IV after a short induction with ibrutinib. Patients reaching undetectable minimal residual disease (uMRD) after 12 cycles of IV are randomised 1:2 to continue ibrutinib or stop treatment. The persistence of uMRD after stopping IV is studied. In addition, in patients who become positive for MRD again after stopping, IV treatment is reinitiated. The efficacy of this approach with regard to progression-free survival 12 months after randomisation is the primary endpoint of the study.Ethics and disseminationThis protocol respects the Helsinki declaration and has been approved by the ethical committee of the Amsterdam Medical Center. Study findings will be disseminated through peer-reviewed papers. All patients who fulfil the inclusion criteria and no-exclusion criteria, and have signed the informed consent form are included in the study.Trial registration numberClinicalTrials.gov Registry (NCT03226301).
Cluster-randomised trial of community-based screening for eye disease in adults in Nepal: the Village-Integrated Eye Worker Trial II (VIEW II) trial protocol
Authors: O'Brien Kieran S , Stevens Valerie M , Byanju Raghunandan , Kandel Ram Prasad , Bhandari Gopal , Bhandari Sadhan , Melo Jason S , Porco Travis C , Lietman Thomas M , Keenan Jeremy D 
Published: October 2020

IntroductionThe majority of blindness worldwide could be prevented or reversed with early diagnosis and treatment, yet identifying at-risk and prevalent cases of eye disease and linking them with care remain important obstacles to addressing this burden. Leading causes of blindness like glaucoma, diabetic retinopathy and age-related macular degeneration have detectable early asymptomatic phases and can cause irreversible vision loss. Mass screening for such diseases could reduce visual impairment at the population level.Methods and analysisThis protocol describes a parallel-group cluster-randomised trial designed to determine whether community-based screening for glaucoma, diabetic retinopathy and age-related macular degeneration reduces population-level visual impairment in Nepal. A door-to-door population census is conducted in all study communities. All adults aged ≥60 years have visual acuity tested at the census visit, and those meeting referral criteria are referred to a local eye care facility for further diagnosis and management. Communities are subsequently randomised to a community-based screening programme or to no additional intervention. The intervention consists of a single round of screening including intraocular pressure and optical coherence tomography assessment of all adults ≥60 years old with enhanced linkage to care for participants meeting referral criteria. Four years after implementation of the intervention, masked outcome assessors conduct a repeat census to collect data on the primary outcome, visual acuity. Individuals with incident visual impairment receive a comprehensive ophthalmological examination to determine the cause of visual impairment. Outcomes are compared by treatment arm according to the originally assigned intervention.Ethics and disseminationThe trial has received ethical approval from the University of California San Francisco Institutional Review Board, Nepal Netra Jyoti Sangh and the Nepal Health Research Council. Results of this trial will be disseminated through publication in peer-reviewed journals and presentation at local and international meetings.Trial registration numberNCT03752840
Development and validation of a novel prognostic model for predicting AMD progression using longitudinal fundus images
Authors: Bridge Joshua , Harding Simon , Zheng Yalin 
Published: October 2020

ObjectiveTo develop a prognostic tool to predict the progression of age-related eye disease progression using longitudinal colour fundus imaging.Methods and analysisPrevious prognostic models using deep learning with imaging data require annotation during training or only use a single time point. We propose a novel deep learning method to predict the progression of diseases using longitudinal imaging data with uneven time intervals, which requires no prior feature extraction. Given previous images from a patient, our method aims to predict whether the patient will progress onto the next stage of the disease. The proposed method uses InceptionV3 to produce feature vectors for each image. In order to account for uneven intervals, a novel interval scaling is proposed. Finally, a recurrent neural network is used to prognosticate the disease. We demonstrate our method on a longitudinal dataset of colour fundus images from 4903 eyes with age-related macular degeneration (AMD), taken from the Age-Related Eye Disease Study, to predict progression to late AMD.ResultsOur method attains a testing sensitivity of 0.878, a specificity of 0.887 and an area under the receiver operating characteristic of 0.950. We compare our method to previous methods, displaying superior performance in our model. Class activation maps display how the network reaches the final decision.ConclusionThe proposed method can be used to predict progression to advanced AMD at some future visit. Using multiple images at different time points improves predictive performance.
Effect of BATHE interview technique on patient satisfaction in an ambulatory family medicine centre in South India
Authors: Chengappa Navnee , Rajkumar Honest Prince Christopher , David Kirubah , Pricilla Ruby Angeline , Rahman Sajitha MF , Rebecca Grace 
Published: October 2020

ObjectiveThe objective of the study is to determine the effect of background, affect, trouble, handling and empathy (BATHE) versus usual interview technique on patient satisfaction during regular consultation with family physicians in ambulatory care.DesignThe research design was a prospective, randomised control trial.SettingThe trial took place in a family practice unit in South India, which was one of the clinical service units of the academic Department of Family Medicine of a tertiary hospital.ParticipantThe eligible participants were adults above the age of 18 years, who did not have any acute presenting illness. The participants should have given consent and also not have any cognitive disability. A total of 138 participants took part in the trial, 70 in BATHE group and 68 in the non-BATHE group. All participants entering the trial completed the questionnaire.ResultThe BATHE group had a significantly higher mean score for questions grouped under professional satisfaction. This included questions on whether the patient felt that the physician treated them as a person and also whether they felt the appropriate clinical examination was communicated to them. The questionnaire used for scoring satisfaction had 18 questions with a maximum possible score of 90. When taking a cut-off of 75% (68) from the total possible score of 90, 72.9% (51) of the participants for whom the BATHE consultation technique was used were satisfied as compared with only 55.9% (30) for whom the routine consultation was carried out. This was statistically significant (χ2=11.15, p value=0.0006)ConclusionThe study suggests that using BATHE in this family practice centre is beneficial in improving the perception of person centeredness in the consultation. However, further studies ruling out all possible bias are needed in our setting before the range of probable benefits of the BATHE technique can be fully gauged.
Excess of cardiovascular deaths during the COVID-19 pandemic in Brazilian capital cities
Authors: Brant Luisa Campos Caldeira , Nascimento Bruno Ramos , Teixeira Renato Azeredo , Lopes Marcelo Antônio Cartaxo Queiroga , Malta Deborah Carvalho , Oliveira Glaucia Maria Moraes , Ribeiro Antonio Luiz Pinho 
Published: October 2020

IntroductionDuring the COVID-19 pandemic, excess mortality has been reported, while hospitalisations for acute cardiovascular events reduced. Brazil is the second country with more deaths due to COVID-19. We aimed to evaluate excess cardiovascular mortality during COVID-19 pandemic in 6 Brazilian capital cities.MethodsUsing the Civil Registry public database, we evaluated total and cardiovascular excess deaths, further stratified in specified cardiovascular deaths (acute coronary syndromes and stroke) and unspecified cardiovascular deaths in the 6 Brazilian cities with greater number of COVID-19 deaths (São Paulo, Rio de Janeiro, Fortaleza, Recife, Belém, Manaus). We compared observed with expected deaths from epidemiological weeks 12–22 of 2020. We also compared the number of hospital and home deaths during the period.ResultsThere were 65 449 deaths and 17 877 COVID-19 deaths in the studied period and cities for 2020. Cardiovascular mortality increased in most cities, with greater magnitude in the Northern capitals. However, while there was a reduction in specified cardiovascular deaths in the most cities, the Northern capitals showed an increase of these events. For unspecified cardiovascular deaths, there was a marked increase in all cities, which strongly correlated to the rise in home deaths (r=0.86, p=0.01).ConclusionExcess cardiovascular mortality was greater in the less developed cities, possibly associated with healthcare collapse. Specified cardiovascular deaths decreased in the most developed cities, in parallel with an increase in unspecified cardiovascular and home deaths, presumably as a result of misdiagnosis. Conversely, specified cardiovascular deaths increased in cities with a healthcare collapse.
Neurogenetic fetal akinesia and arthrogryposis: genetics, expanding genotype-phenotypes and functional genomics
Authors: Ravenscroft Gina , Clayton Joshua S , Faiz Fathimath , Sivadorai Padma , Milnes Di , Cincotta Rob , Moon Phillip , Kamien Ben , Edwards Matthew , Delatycki Martin , Lamont Phillipa J , Chan Sophelia HS , Colley Alison , Ma Alan , Collins Felicity , Hennington Lucinda , Zhao Teresa , McGillivray George , Ghedia Sondhya , Chao Katherine , O'Donnell-Luria Anne , Laing Nigel G , Davis Mark R 
Published: October 2020

BackgroundFetal akinesia and arthrogryposis are clinically and genetically heterogeneous and have traditionally been refractive to genetic diagnosis. The widespread availability of affordable genome-wide sequencing has facilitated accurate genetic diagnosis and gene discovery in these conditions.MethodsWe performed next generation sequencing (NGS) in 190 probands with a diagnosis of arthrogryposis multiplex congenita, distal arthrogryposis, fetal akinesia deformation sequence or multiple pterygium syndrome. This sequencing was a combination of bespoke neurogenetic disease gene panels and whole exome sequencing. Only class 4 and 5 variants were reported, except for two cases where the identified variants of unknown significance (VUS) are most likely to be causative for the observed phenotype. Co-segregation studies and confirmation of variants identified by NGS were performed where possible. Functional genomics was performed as required.ResultsOf the 190 probands, 81 received an accurate genetic diagnosis. All except two of these cases harboured class 4 and/or 5 variants based on the American College of Medical Genetics and Genomics guidelines. We identified phenotypic expansions associated with CACNA1S, CHRNB1, GMPPB and STAC3. We describe a total of 50 novel variants, including a novel missense variant in the recently identified gene for arthrogryposis with brain malformations—SMPD4.ConclusionsComprehensive gene panels give a diagnosis for a substantial proportion (42%) of fetal akinesia and arthrogryposis cases, even in an unselected cohort. Recently identified genes account for a relatively large proportion, 32%, of the diagnoses. Diagnostic-research collaboration was critical to the diagnosis and variant interpretation in many cases, facilitated genotype-phenotype expansions and reclassified VUS through functional genomics.
Development and application of an outcome-centric approach for conducting overviews of reviews
Authors: Kho Michelle E. , Poitras Veronica J. , Janssen Ian , Chaput Jean-Philippe , Saunders Travis J. , Giangregorio Lora M. , Tomasone Jennifer R. , Ross-White Amanda , Ross Robert 
Published: October 2020

There are gaps in current guidance concerning how to conduct overviews of systematic reviews in an outcome-centric manner. Herein we summarize the methods and lessons learned from conducting 4 outcome-centric overviews to help inform the Canadian 24-Hour Movement Guidelines for Adults aged 18–64 years and Adults aged 65 years or older on the topics of resistance training, balance and functional training, sedentary behaviour, sleep duration. We defined “critical” and “important” outcomes a priori. We used AMSTAR 2 to assess review quality and sought 1 systematic review per outcome. If multiple reviews were required to address subgroups for an outcome, we calculated the corrected covered area (CCA) to quantify overlap. We report our methodology in a PRISMA table. Across the 4 overviews, authors reviewed 1110 full texts; 45 were retained (low to high quality per AMSTAR 2), representing 950 primary studies, enrolling over 5 385 500 participants. Of 46 outcomes, we identified data for 35. Nineteen outcomes required >1 review (CCA range: 0% to 71.4%). Our outcome-centric overviews addressed unique aspects of overviews, including selection and quality assessment of included reviews, and overlap. Lessons learned included consistent application of methodological principles to minimize bias and optimize reporting transparency. Novelty Overviews of reviews synthesize systematic reviews in a rigorous and transparent manner. Outcome-centric systematic reviews assess the quality of evidence for primary studies contributing to an outcome. This manuscript describes the development and application of extending the concept of outcome-centric systematic reviews to the design and conduct of outcome-centric overviews.
The effect of regional quadriceps anatomical parameters on angle-specific isometric torque expression
Authors: Oranchuk Dustin J. , Hopkins William G. , Nelson André R. , Storey Adam G. , Cronin John B. 
Published: October 2020

The length–tension relationship affects knee extension performance; however, whether anatomical variations in different quadriceps regions affect this relationship is unknown. Regional (proximal, middle, distal) quadriceps thickness (MT), pennation angle, and fascicle length of 24 males (48 limbs) were assessed via ultrasonography. Participants also performed maximal voluntary isometric torque (MVIT) assessments at 40°, 70°, and 100° of knee flexion. Measures were recorded on 3 separate occasions. Linear regression models predicting angle-specific torque from regional anatomy provided adjusted simple and multiple correlations (√adjR2) with bootstrapped compatibility limits to assess magnitude. Middle vastus lateralis MT and MVIT at 100° (√adjR2 = 0.64) was the largest single correlation, with distal vastus lateralis MT having the greatest mean correlations regardless of angle (√adjR2 = 0.61 ± 0.05, mean ± SD). Lateral distal MT and architecture had larger (Δ√adjR2 = 0.01 to 0.43) single and multiple correlations with MVIT than the lateral proximal (√adjR2 = 0.15 to 0.69 vs −0.08 to 0.65). Conversely, middle anterior MT had greater (Δ√adjR2 = 0.08 to 0.38) single and multiple correlations than proximal MT (√adjR2 = 0.09 to 0.49 vs −0.21 to 0.14). The length–tension relationship was trivially affected by regional quadriceps architecture. The middle and distal quadriceps were the strongest predictors of MVIT at all joint angles. Therefore, researchers may wish to focus on middle and distal lateral quadriceps anatomy when performing ultrasonographic evaluations. Novelty: The length–tension relationship is minimally affected by regional quadriceps anatomical parameters. Middle and distal vastus lateralis and lateral vastus intermedius anatomy were consistently the best predictors of torque. Practitioners may focus their assessments on the middle and distal regions of the lateral quadriceps’ musculature.