bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessment of patient-reported outcomes after polytrauma – instruments and methods: a systematic review
Authors: Ritschel Michaela , Kuske Silke , Gnass Irmela , Andrich Silke , Moschinski Kai , Borgmann Sandra Olivia , Herrmann-Frank Annegret , Metzendorf Maria-Inti , Wittgens Charlotte , Flohé Sascha , Sturm Johannes , Windolf Joachim , Icks Andrea 
Published: December 2021

ObjectivesWe (1) collected instruments that assess health-related quality of life (HRQoL), activities of daily living (ADL) and social participation during follow-up after polytrauma, (2) described their use and (3) investigated other relevant patient-reported outcomes (PROs) assessed in the studies.DesignSystematic Review using the Preferred Reporting Items for Systematic Review and Meta-Analysis guideline.Data sourcesMEDLINE, Embase, CINAHL, PsycINFO, CENTRAL, as well as the trials registers ClinicalTrials.gov and WHO ICTRP were searched from January 2005 to April 2018.Eligibility criteriaAll original empirical research published in English or German including PROs of patients aged 18–75 years with an Injury Severity Score≥16 and/or an Abbreviated Injury Scale≥3. Studies with defined injuries or diseases (e.g. low-energy injuries) and some text types (e.g. grey literature and books) were excluded. Systematic reviews and meta-analyses were excluded, but references screened for appropriate studies.Data extraction and synthesisData extraction, narrative content analysis and a critical appraisal (e.g. UK National Institute for Health and Care Excellence) were performed by two reviewers independently.ResultsThe search yielded 3496 hits; 54 publications were included. Predominantly, HRQoL was assessed, with Short Form-36 Health Survey applied most frequently. ADL and (social) participation were rarely assessed. The methods most used were postal surveys and single assessments of PROs, with a follow-up period of one to one and a half years. Other relevant PRO areas reported were function, mental disorders and pain.ConclusionsThere is a large variation in the assessment of PROs after polytrauma, impairing comparability of outcomes. First efforts to standardise the collection of PROs have been initiated, but require further harmonisation between central players. Additional knowledge on rarely reported PRO areas (e.g. (social) participation, social networks) may lead to their consideration in health services provision.PROSPERO registration numberCRD42017060825.
Living conditions, HIV and gender affirmation care pathways of transgender people living with HIV in France: a nationwide, comprehensive, cross-sectional, community-based research protocol (ANRS Trans&HIV)
Authors: Mora Marion , Rincon Giovanna , Bourrelly Michel , Maradan Gwenaëlle , Freire Maresca Anaenza , Michard Florence , Rouveix Elisabeth , Pannetier Julie , Leriche Diane , Alain Tristan , Yazdanpanah Yazdan , Michels David , Spire Bruno 
Published: December 2021

IntroductionTransgender identity is poorly accepted in France, and data on living conditions and the daily difficulties transgender people encounter are scarce. This lack of data reinforces their invisibility in social life, contributes to their stigmatisation and probably increases the burden of HIV infection, especially for HIV-positive transgender people (TRHIV). The main objective of the community-based research study ANRS Trans&HIV is to identify personal and social situations of vulnerability in TRHIV, the obstacles they encounter in terms of access to and retention in medical care, and their gender affirmation and HIV care needs.Methods and analysisANRS Trans&HIV is a national, comprehensive, cross-sectional survey of all TRHIV currently being followed in HIV care units in France. TRHIV women are exclusively included in the quantitative component, and TRHIV men in the qualitative component. Data are collected by community-based interviewers and will be analysed to explore patient care pathways and living conditions in the TRHIV population with regard to gender affirmation and HIV. Data collection began in October 2020 and should be completed in December 2021. The statistical analyses techniques used will be adapted to each of the study’s objectives and to the type of data collected (cross-sectional (questionnaires) and retrospective (biographical trajectory)). The study’s results will provide a greater understanding of TRHIV health needs in order to suggest possible national recommendations for comprehensive HIV and gender affirmation medical care.Ethics and disseminationANRS Trans&HIV was approved by Inserm’s Ethical Evaluation Committee (no 20-694 on 12 May 2020) and is registered with the National Commission on Informatics and Liberty under number 2518030720. Potential participants are informed about the study through an information note provided by their attending HIV physician. All results published in peer-reviewed journals will be disseminated to the HIV transgender community, institutional stakeholders and healthcare providers.Trial registration numberNCT04849767.
Cohort profile: demographic and clinical characteristics of the MILESTONE longitudinal cohort of young people approaching the upper age limit of their child mental health care service in Europe
Authors: Gerritsen Suzanne E , Maras Athanasios , van Bodegom Larissa S , Overbeek Mathilde M , Verhulst Frank C , Wolke Dieter , Appleton Rebecca , Bertani Angelo , Cataldo Maria G , Conti Patrizia , Da Fonseca David , Davidović Nikolina , Dodig-Ćurković Katarina , Ferrari Cecilia , Fiori Federico , Franić Tomislav , Gatherer Charlotte , De Girolamo Giovanni , Heaney Natalie , Hendrickx Gaëlle , Kolozsvari Alfred , Levi Flavia Micol , Lievesley Kate , Madan Jason , Martinelli Ottaviano , Mastroianni Mathilde , Maurice Virginie , McNicholas Fiona , O'Hara Lesley , Paul Moli , Purper-Ouakil Diane , de Roeck Veronique , Russet Frédérick , Saam Melanie C , Sagar-Ouriaghli Ilyas , Santosh Paramala J , Sartor Anne , Schandrin Aurélie , Schulze Ulrike M E , Signorini Giulia , Singh Swaran P , Singh Jatinder , Street Cathy , Tah Priya , Tanase Elena , Tremmery Sabine , Tuffrey Amanda , Tuomainen Helena , van Amelsvoort Therese A M J , Wilson Anna , Walker Leanne , Dieleman Gwen C 
Published: December 2021

PurposeThe presence of distinct child and adolescent mental health services (CAMHS) and adult mental health services (AMHS) impacts continuity of mental health treatment for young people. However, we do not know the extent of discontinuity of care in Europe nor the effects of discontinuity on the mental health of young people. Current research is limited, as the majority of existing studies are retrospective, based on small samples or used non-standardised information from medical records. The MILESTONE prospective cohort study aims to examine associations between service use, mental health and other outcomes over 24 months, using information from self, parent and clinician reports.ParticipantsSeven hundred sixty-three young people from 39 CAMHS in 8 European countries, their parents and CAMHS clinicians who completed interviews and online questionnaires and were followed up for 2 years after reaching the upper age limit of the CAMHS they receive treatment at.Findings to dateThis cohort profile describes the baseline characteristics of the MILESTONE cohort. The mental health of young people reaching the upper age limit of their CAMHS varied greatly in type and severity: 32.8% of young people reported clinical levels of self-reported problems and 18.6% were rated to be ‘markedly ill’, ‘severely ill’ or ‘among the most extremely ill’ by their clinician. Fifty-seven per cent of young people reported psychotropic medication use in the previous half year.Future plansAnalysis of longitudinal data from the MILESTONE cohort will be used to assess relationships between the demographic and clinical characteristics of young people reaching the upper age limit of their CAMHS and the type of care the young person uses over the next 2 years, such as whether the young person transitions to AMHS. At 2 years follow-up, the mental health outcomes of young people following different care pathways will be compared.Trial registration numberNCT03013595.
Novel longitudinal Multiple Overall Toxicity (MOTox) score to quantify adverse events experienced by patients during chemotherapy treatment: a retrospective analysis of the MRC BO06 trial in osteosarcoma
Authors: Spreafico Marta , Ieva Francesca , Arlati Francesca , Capello Federico , Fatone Federico , Fedeli Filippo , Genalti Gianmarco , Anninga Jakob , Gelderblom Hans , Fiocco Marta 
Published: December 2021

ObjectivesThis study aims at exploring and quantifying multiple types of adverse events (AEs) experienced by patients during cancer treatment. A novel longitudinal score to evaluate the Multiple Overall Toxicity (MOTox) burden is proposed. The MOTox approach investigates the personalised evolution of high overall toxicity (high-MOTox) during the treatment.DesignRetrospective analysis of the MRC-BO06/EORTC-80931 randomised controlled trial for osteosarcoma.SettingInternational multicentre population-based study.ParticipantsA total of 377 patients with resectable high-grade osteosarcoma, who completed treatment within 180 days after randomisation without abnormal dosages (+25% higher than planned).InterventionsPatients were randomised to six cycles of conventional versus dose-intense regimens of doxorubicin and cisplatin. Non-haematological toxicity data were collected prospectively and graded according to the Common Terminology Criteria for Adverse Events (CTCAE).Main outcome measuresThe MOTox score described the overall toxicity burden in terms of multiple toxic AEs, maximum-severity episode and cycle time-dimension. Evolution of high-MOTox was assessed through multivariable models, that investigated the impact of personalised characteristics (eg, achieved chemotherapy dose, previous AEs or biochemical factors) cycle-by-cycle.ResultsA cycle-by-cycle analysis identifies different evolutions of MOTox levels during treatment, detecting differences in patients’ health. Mean MOTox values and percentages of patients with high-MOTox decreased cycle-by-cycle from 2.626 to 1.953 and from 57.8% to 36.6%, respectively. High-MOTox conditions during previous cycles were prognostic risk factors for a new occurrence (ORs range from 1.522 to 4.439), showing that patient’s history of toxicities played an important role in the evolution of overall toxicity burden during therapy. Conventional regimen may be preferred to dose-intense in terms of AEs at cycles 2–3 (p<0.05).ConclusionsThe novel longitudinal method developed can be applied to any cancer studies with CTCAE-graded toxicity data. After validation in other studies, the MOTox approach may lead to improvements in healthcare assessment and treatment planning.Trial registration numberISRCTN86294690; Post-results.
Cannabis and cannabidiol use among autistic and non-autistic adults in the UK: a propensity score-matched analysis
Authors: Hua Daniel Ying-Heng , Lees Rachel , Brosnan Mark , Freeman Tom P 
Published: December 2021

ObjectivesTo assess whether autistic and non-autistic adults differ in their cannabis and cannabidiol (CBD) use, their perceptions of cannabinoid products and their cannabinoid-related support-seeking behaviours.DesignCross-sectional survey.ParticipantsRespondents to an online survey, who self-reported an autism-spectrum disorder diagnosis (autistic participants) or no issues relating to autism (controls). Exclusion criteria were: related/subclinical issues relating to autism, non-UK residence, under 16 years old. Propensity score matching was used to match autistic participants and controls on age, gender and ethnicity. The full-sample analysis included 269 participants and the propensity-matched sample analysis included 166 participants. Propensity-matched analysis was used for primary analysis and was considered robust if supported by triangulation with full-sample analysis.ResultsAutistic participants were more likely to have used CBD in the past 12 months compared with controls (OR=3.52, 95% CI 1.57 to 7.87, p=0.002). They used CBD on more days in the past 12 months (M=34, SD=93) compared with controls (M=17, SD=69, p=0.002). Autistic participants reported trusting the news and doctors less as sources of cannabinoid-related information than controls (p=0.024 and p=0.003, respectively). Autistic participants endorsed the following barriers to cannabinoid-related support seeking more than controls: ‘worrying they won’t understand me’ (OR=3.25, 95% CI 1.67 to 6.33, p<0.001), ‘going somewhere unfamiliar’ (OR=5.29, 95% CI 2.62 to 10.67, p<0.001) and ‘being in a crowded or chaotic place’ (OR=9.79, 95% CI 4.18 to 22.89, p<0.001).ConclusionResults indicate a higher prevalence and frequency of CBD use, but not cannabis use, among autistic individuals compared with controls. Findings also suggest appropriate methods to disseminate cannabinoid-related support to autistic individuals, and indicate differences in the potential barriers autistic and non-autistic individuals may face when seeking cannabinoid-related support.
Bronchial Thermoplasty Global Registry (BTGR): 2-year results
Authors: Torrego Alfons , Herth Felix J , Munoz-Fernandez Ana M , Puente Luis , Facciolongo Nicola , Bicknell Stephen , Novali Mauro , Gasparini Stefano , Bonifazi Martina , Dheda Keertan , Andreo Felipe , Votruba Praha , Langton David , Flandes Javier , Fielding David , Bonta Peter I , Skowasch Dirk , Schulz Christian , Darwiche Kaid , McMullen Edmund , Grubb G. Mark , Niven Robert 
Published: December 2021

ObjectivesBronchial thermoplasty (BT) is a device-based treatment for subjects ≥18 years with severe asthma not well controlled with inhaled corticosteroids and long-acting beta-agonists. The Bronchial Thermoplasty Global Registry (BTGR) collected real-world data on subjects undergoing this procedure.DesignThe BTGR is an all-comer, prospective, open-label, multicentre study enrolling adult subjects indicated for and treated with BT.SettingEighteen centres in Spain, Italy, Germany, the UK, the Netherlands, the Czech Republic, South Africa and AustraliaParticipantsOne hundred fifty-seven subjects aged 18 years and older who were scheduled to undergo BT treatment for asthma. Subjects diagnosed with other medical conditions which, in the investigator’s opinion, made them inappropriate for BT treatment were excluded.Primary and secondary outcome measuresBaseline characteristics collected included demographics, Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Test (ACT), medication usage, forced expiratory volume in one second and forced vital capacity, medical history, comorbidities and 12-month baseline recall data (severe exacerbations (SE) and healthcare utilisation). SE incidence and healthcare utilisation were summarised at 1 and 2 years post-BT.ResultsSubjects’ baseline characteristics were representative of persons with severe asthma. A comparison of the proportion of subjects experiencing events during the 12 months prior to BT to the 2-year follow-up showed a reduction in SE (90.3% vs 56.1%, p<0.0001), emergency room visits (53.8% vs 25.5%, p<0.0001) and hospitalisations (42.9% vs 23.5 %, p=0.0019). Reductions in asthma maintenance medication dosage were also observed. AQLQ and ACT scores improved from 3.26 and 11.18 at baseline to 4.39 and 15.54 at 2 years, respectively (p<0.0001 for both AQLQ and ACT).ConclusionsThe BTGR demonstrates sustained improvement in clinical outcomes and reduction in asthma medication usage 2 years after BT in a real-world population. This is consistent with results from other BT randomised controlled trials and registries and further supports improvement in asthma control after BT.Trial registration numberNCT02104856.
Assessing the impact of screening, early identification and intervention programmes for chronic kidney disease: protocol for a scoping review
Authors: Okpechi Ikechi G , Caskey Fergus J , Gaipov Abduzhappar , Tannor Elliot K , Hamonic Laura N , Ashuntantang Gloria , Donner Jo-Ann , Figueiredo Ana , Inagi Reiko , Madero Magdalena , Malik Charu , Moorthy Monica , Pecoits-Filho Roberto , Tesar Vladimir , Levin Adeera , Jha Vivekanand 
Published: December 2021

IntroductionChronic kidney disease (CKD) is a major threat to public health, especially in low-income and lower middle-income countries, where resources for treating patients with advanced CKD are scarce. Although early CKD identification and intervention hold promise for reducing the burden of CKD and risk factors, it remains unclear if an uniform strategy can be applicable across all income groups. The aim of this scoping review is to synthesise available evidence on early CKD identification programmes in all world regions and income groups. The study will also identify efforts that have been made to use interventions and implementation of early identification programmes for CKD across countries and income groups.Methods and analysisThis review will be guided by the methodological framework for conducting scoping studies developed by Arksey and O’Malley. Empirical (Medline, Embase, Cochrane Library, CINAHL, ISI Web of Science and PsycINFO) and grey literature references will be searched to identify studies on CKD screening, early identification and interventions across all populations. Two reviewers will independently screen references in consecutive stages of title/abstract screening and then full-text screening. We will use a general descriptive overview, tabular summaries and content analysis on extracted data.Ethics and disseminationThe findings from our planned scoping review will enable us to identify items in early identification programmes that can be used in developing screening toolkits for CKD. We will disseminate our findings using traditional approaches that include open-access peer-reviewed publication, scientific presentations and a white paper (call to action) report. Ethical approval will not be required for this scoping review as the data will be extracted from already published studies.
CTN 328: immunogenicity outcomes in people living with HIV in Canada following vaccination for COVID-19 (HIV-COV): protocol for an observational cohort study
Authors: Costiniuk Cecilia T , Singer Joel , Langlois Marc-André , Kulic Iva , Needham Judy , Burchell Ann , Jenabian Mohammad-Ali , Walmsley Sharon , Ostrowski Mario , Kovacs Colin , Tan Darrell , Harris Marianne , Hull Mark , Brumme Zabrina , Brockman Mark , Margolese Shari , Mandarino Enrico , Angel Jonathan B , Routy Jean-Pierre , Anis Aslam H , Cooper Curtis 
Published: December 2021

IntroductionMost existing vaccines require higher or additional doses or adjuvants to provide similar protection for people living with HIV (PLWH) compared with HIV-uninfected individuals. Additional research is necessary to inform COVID-19 vaccine use in PLWH.Methods and analysisThis multicentred observational Canadian cohort study will enrol 400 PLWH aged>16 years from Montreal, Ottawa, Toronto and Vancouver. Subpopulations of PLWH of interest will include individuals: (1) >55 years of age; (2) with CD4 counts <350 cells/mm3; (3) with multimorbidity (>2 comorbidities) and (4) ‘stable’ or ‘reference’ PLWH (CD4 T cells >350 cells/mm3, suppressed viral load for>6 months and<1 comorbidity). Data for 1000 HIV-negative controls will be obtained via a parallel cohort study (Stop the Spread Ottawa), using similar time points and methods. Participants receiving>1 COVID-19 vaccine will attend five visits: prevaccination; 1 month following the first vaccine dose; and at 3, 6 and 12 months following the second vaccine dose. The primary end point will be the percentage of PLWH with COVID-19-specific antibodies at 6 months following the second vaccine dose. Humoral and cell-mediated immune responses, and the interplay between T cell phenotypes and inflammatory markers, will be described. Regression techniques will be used to compare COVID-19-specific immune responses to determine whether there are differences between the ‘unstable’ PLWH group (CD4 <350 cells/mm3), the stable PLWH cohort and the HIV-negative controls, adjusting for factors believed to be associated with immune response. Unadjusted analyses will reveal whether there are differences in driving factors associated with group membership.Ethics and disseminationResearch ethics boards at all participating institutions have granted ethics approval for this study. Written informed consent will be obtained from all study participants prior to enrolment. The findings will inform the design of future COVID-19 clinical trials, dosing strategies aimed to improve immune responses and guideline development for PLWH.Trial registration numberNCT04894448.
Sodium selenate as a disease-modifying treatment for progressive supranuclear palsy: protocol for a phase 2, randomised, double-blind, placebo-controlled trial
Authors: Vivash Lucy , Bertram Kelly L , Malpas Charles B , Marotta Cassandra , Harding Ian H , Kolbe Scott , Fielding Joanne , Clough Meaghan , Lewis Simon J G , Tisch Stephen , Evans Andrew H , O’Sullivan John D , Kimber Thomas , Darby David , Churilov Leonid , Law Meng , Hovens Christopher M , Velakoulis Dennis , O’Brien Terence J 
Published: December 2021

IntroductionProgressive supranuclear palsy (PSP) is a neurodegenerative disorder for which there are currently no disease-modifying therapies. The neuropathology of PSP is associated with the accumulation of hyperphosphorylated tau in the brain. We have previously shown that protein phosphatase 2 activity in the brain is upregulated by sodium selenate, which enhances dephosphorylation. Therefore, the objective of this study is to evaluate the efficacy and safety of sodium selenate as a disease-modifying therapy for PSP.Methods and analysisThis will be a multi-site, phase 2b, double-blind, placebo-controlled trial of sodium selenate. 70 patients will be recruited at six Australian academic hospitals and research institutes. Following the confirmation of eligibility at screening, participants will be randomised (1:1) to receive 52 weeks of active treatment (sodium selenate; 15 mg three times a day) or matching placebo. Regular safety and efficacy visits will be completed throughout the study period. The primary study outcome is change in an MRI volume composite (frontal lobe+midbrain–3rd ventricle) over the treatment period. Analysis will be with a general linear model (GLM) with the MRI composite at 52 weeks as the dependent variable, treatment group as an independent variable and baseline MRI composite as a covariate. Secondary outcomes are change in PSP rating scale, clinical global impression of change (clinician) and change in midbrain mean diffusivity. These outcomes will also be analysed with a GLM as above, with the corresponding baseline measure entered as a covariate. Secondary safety and tolerability outcomes are frequency of serious adverse events, frequency of down-titration occurrences and frequency of study discontinuation. Additional, as yet unplanned, exploratory outcomes will include analyses of other imaging, cognitive and biospecimen measures.Ethics and disseminationThe study was approved by the Alfred Health Ethics Committee (594/20). Each participant or their legally authorised representative and their study partner will provide written informed consent at trial commencement. The results of the study will be presented at national and international conferences and published in peer-reviewed journals.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12620001254987).