bluuebunny/crossref_metadata_2025_split huggingface dataset:
Guidelines for the development and validation of patient-reported outcome measures: a scoping review
Authors: Jung Andres , Challoumas Dimitris , Pagels Larissa , Armijo-Olivo Susan , Braun Tobias , Luedtke Kerstin 
Published: May 2024

ObjectiveThe objectives of this scoping review were to provide an overview of existing guidelines for the development and validation of patient-reported outcome measures (PROMs), review them for comprehensiveness and clarity and provide recommendations for their use based on the goals of the instrument developers.DesignScoping review.MethodsA literature search was performed in PubMed, Scopus, PsycInfo and Google Scholar up to 2 June 2023 to identify guidelines for the development and validation of PROMs. Screening of records and reports as well as data extraction were performed by two reviewers. To assess the comprehensiveness of the included guidelines, a mapping synthesis was performed and steps to develop and validate a measurement instrument outlined in the included guidelines were mapped to an a priori framework including 20 steps, which was based on the guideline by de Vetet al.ResultsA total of 40 guidelines were included. Statistical advice (at least partially) was provided in 98% of the guidelines (39/40) and 88% (35/40) of the guidelines included examples for steps required to develop and validate PROMs. However, 78% (31/40) of the guidelines were not comprehensive and two essential steps in PROM development (‘consideration and elaboration of the measurement model’ and ‘responsiveness’) were not included in 80% and 72% of the guidelines, respectively. Three guidelines included all 20 steps and six included almost all steps (≥90% of steps) for developing and validating a PROM.DiscussionMost guidelines on PROM development and validation do not appear to be comprehensive, and some crucial steps are missing in most guidelines. Nevertheless, for some purposes of PROMs, many guidelines provide helpful advice and support.ConclusionAt least 15 guidelines may be recommended, including three comprehensive guidelines that can be recommended for the development and validation of PROMs for most purposes (eg, to discriminate between subjects with a particular condition and subjects without that condition, to evaluate the effects of treatments (between a pre and post time-points) or to evaluate a status quo).
The state of mental health among Ebola virus disease survivors through a cross-sectional study in Sierra Leone
Authors: Schindell Brayden G , Fredborg Bev , Kowalec Kaarina , Shaw Souradet , Kangbai Jia B , Kindrachuk Jason 
Published: May 2024

BackgroundThe West African Ebola virus disease (EVD) epidemic resulted in >28 000 disease cases and >11 000 fatalities. The unprecedented number of survivors from this epidemic has raised questions about the long-term mental health impacts of EVD survivorship and the capacity to meet these needs.ObjectivesAssess the frequency and factors associated with mental health consequences of EVD survivorship in Sierra Leone.MethodsA cross-sectional study of 595 EVD survivors and 403 close contacts (n=998) from Sierra Leone assessed via in-person survey between November 2021 and March 2022. The assessment included validated mental health screening tools (Patient Health Questionnaire-9, PTSD Checklist-5, Alcohol Use Disorders Identification Test, Drug Abuse Screening Test-20) to indicate the presence/absence of disorder. The frequency of each disorder and factors associated with each disorder were assessed.FindingsEVD-associated post-traumatic stress disorder (PTSD) was reported by 45.7% (n=257) of EVD survivors. Moreover, 3.9% (n=22) and 12.0% (n=67) of EVD survivors reported major depression (MD) and substance use, respectively; all mental health outcomes were higher than baseline rates in the region (PTSD: 6%–16%, MD: 1.1%, substance use: 2.2%). PTSD among EVD survivors was associated with acute EVD duration of ≥21 days (adjusted OR, AOR 2.24, 95% CI 1.16 to 4.43), 35–44 years of age (AOR 3.31, 95% CI 1.33 to 8.24; AOR 2.99, 95% CI 1.09 to 8.24) and residential mobility (AOR 4.16, 95% CI 2.35 to 7.35).ConclusionsConcerningly, the levels of mental health disorders among EVD survivors in Sierra Leone remained elevated 6–8 years after recovery.Clinical implicationsResults can be used to inform policy efforts and target resources to address mental health in EVD survivors.
Illness perception in functional neurological disorder: low illness coherence and personal control
Authors: Joos Andreas , Popkirov Stoyan , Lahmann Claas , Jöbges Michael , Herrmann Christoph , Maner Philipp , Schörner Kai , Birke Gunnar , Hartmann Armin 
Published: May 2024

IntroductionIllness perception refers to patients’ subjective representations and appraisals of somatic and mental symptoms. These are relevant for self-management and outcome. In clinical practice, patients with functional neurological disorder (FND) often encounter a fragmented biomedical attitude, which leaves them without clear concepts. In this context, illness perception is relevant.MethodsIllness perception was assessed in FND patients and compared with samples of psychosomatic patients (PSM) as well as poststroke patients (STR). The three samples (FND, n=87; PSM, n=97 and STR, n=92) were almost all in inpatient treatment or rehabilitation. Illness perception was assessed with the revised German version of the Illness Perception Questionnaire (IPQ-R). For assessments of correlations, depressive symptoms were tested with the Patient Health Questionnaire-9, dissociative and functional neurological symptoms by the German adaption of the Dissociative Experiences Scale and biopsychosocial complexity by the INTERMED Self-Assessment questionnaire.ResultsApart from the chronicity subscale, all dimensions of the IPQ-R differed between groups. FND patients perceived lower illness coherence and personal control than both other groups and attributed their illness more to chance than to behavioural risk factors. PSM patients had the strongest emotional representations. There were only few correlations with dissociative scores and biopsychosocial complexity.ConclusionIllness perception is an important issue in patients with FND with particular emphasis on low illness coherence and personal control. Missing associations with biopsychosocial complexity suggest that subjective illness perception is an important complementary but separate issue, which likely influences therapeutic alliance and self-management in FND. Future studies should assess its influences on outcome.Trial registration numberDRKS00024685; German Clinical Trials Register;www.drks.de.
Inhaled Nitric Oxide ReDuce postoperatIve pulmoNAry complicaTions in patiEnts with recent COVID-19 infection (INORDINATE): protocol for a randomised controlled trial
Authors: Zheng Ziyu , Wang Lini , Wang Shuxiu , Fan Qianqian , Zhang Hui , Luo Gang , Gao Baobao , Yang Xue , Zhao Bingqing , Wang Xiaomei , Dong Hailong , Nie Huang , Lei Chong 
Published: May 2024

BackgroundA history of SARS-CoV-2 infection has been reported to be associated with an increased risk of postoperative pulmonary complications (PPCs). Even mild PPCs can elevate the rates of early postoperative mortality, intensive care unit (ICU) admission and prolong the length of ICU and/or hospital stays. Consequently, it is crucial to develop perioperative management strategies that can mitigate these increased risks in surgical patients who have recently been infected with SARS-CoV-2. Accumulating evidence suggests that nitric oxide (NO) inhalation might be effective in treating COVID-19. NO functions in COVID-19 by promoting vasodilation, anticoagulation, anti-inflammatory and antiviral effects. Therefore, our study hypothesises that the perioperative use of NO can effectively reduce PPCs in patients with recent SARS-CoV-2 infection.Method and analysisA prospective, double-blind, single-centre, randomised controlled trial is proposed. The trial aims to include participants who are planning to undergo surgery with general anaesthesia and have been recently infected with SARS-CoV-2 (within 7 weeks). Stratified allocation of eligible patients will be performed at a 1:1 ratio based on the predicted risk of PPCs using the Assess Respiratory Risk in Surgical Patients in Catalonia risk index and the time interval between infection and surgery.The primary outcome of the study will be the presence of PPCs within the first 7 days following surgery, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm and aspiration pneumonitis. The primary outcome will be reported as counts (percentage) and will be compared using a two-proportion χ2test. The common effect across all primary components will be estimated using a multiple generalised linear model.Ethics and disseminationThe trial is approved by the Institutional Review Board of Xijing Hospital (KY20232058-F1). The findings, including positive, negative and inconclusive results, will be published in scientific journals with peer-review processes.Trial registration numberNCT05721144.
Survival status and predictors of mortality among preterm neonates admitted in Bench Sheko Zone, Sheka Zone and Keffa Zone Governmental Hospitals, Southwest Ethiopia (2021): prospective follow-up study
Authors: Mihretu Esmelealem , Genie Yalemtsehay Dagnaw , Adugnaw Emebet , Shibabaw Aster Tadesse 
Published: May 2024

IntroductionPrematurity presents a significant challenge to the global community due to the rapid increase in its incidence and its disproportionate contribution to increased infant mortality rates.ObjectiveTo assess the survival status and predictors of mortality among preterm neonates.DesignA multicentre prospective follow-up study was used.Setting625 preterm neonates were admitted to hospitals for secondary level of care. The study covers the Bench Maji Zone, Keffa Zone, Sheka Zone, nearby woredas and portions of the Gambella area in Southwest Ethiopia.Participants614 preterm neonates with gestational age less than 37 weeks were entered for follow-up and 400 neonates were censored. Neonates with severe fetal malformations and neonates who need urgent referral were excluded from the study.ResultsOverall, 200 (32.57%) participants died with an incidence rate of 61.69 deaths per 1000 person-day observations (95% CI: 53.71 to 70.86). Poor kangaroo mother care (KMC) services (adjusted HR (AHR)=0.19, 95% CI: 0.12 to 0.29), sex (AHR=0.66, 95%, CI: 0.47 to 0.94), not initiating breast feeding (HR=2.78, 95% CI: 1.8 to 4.28), hypothermia (AHR=0.63, 95% CI: 0.44 to 0.92), anaemia (AHR=6.2, 95% CI: 2.34 to 16.43) and gestational age less than 28 weeks (AHR=9.28, 95% CI: 1.78 to 48.42) were independent predictors.Conclusion and recommendationThe rate of preterm neonatal mortality was high compared with the Ethiopia Demographic and Health Survey report nationally. Healthcare workers should encourage KMC services and breastfeeding initiation and prevent preterm neonates from being anaemic to increase their chances of survival.
Health risks of exposure to air pollution in areas where coal-fired power plants are located: protocol for a scoping review
Authors: Mahlangeni Nomfundo , Kapwata Thandi , Laban Tracey , Wright Caradee Yael 
Published: May 2024

IntroductionCoal-fired power plants are major sources of air pollution which impact human health. Coal combustion byproducts released into the air include particulate matter, nitrogen oxides and sulphur dioxide. Exposure to fine particulate matter is associated with increased risk of mortality. This scoping review will examine and summarise the current literature on the health risks of exposure to air pollution in areas in which coal-fired power plants exist.Methods and analysisThis scoping review will be conducted according to the Joanna Briggs Institute methodological framework and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Five electronic databases (PubMed, ScienceDirect, Scopus, Web of Science and Google Scholar) will be searched for relevant articles. Studies will be included up until 31 January 2024. There will be no restriction on geographical area. The searches will be limited to studies published in English. Title, abstract, full-text screening and data extraction of relevant articles will be done by two independent reviewers. Discrepancies will be resolved by group discussion. The findings will be presented in tables with a narrative summary. This review will consider epidemiological studies and grey literature that report on the health risks of exposure to air pollution in areas where coal-fired power plants exist.Ethics and disseminationAll data will be collected from published and grey literature. Ethics approval is therefore not required. We will submit our findings for publication in a peer-reviewed journal.
Artificial intelligence-based prediction of diabetic retinopathy evolution (EviRed): protocol for a prospective cohort
Authors: Tadayoni Ramin , Massin Pascale , Bonnin Sophie , Magazzeni Stéphanie , Lay Bruno , Le Guilcher Alexandre , Vicaut Eric , Couturier Aude , Quellec Gwenolé , Investigators EviRed 
Published: May 2024

IntroductionAn important obstacle in the fight against diabetic retinopathy (DR) is the use of a classification system based on old imaging techniques and insufficient data to accurately predict its evolution. New imaging techniques generate new valuable data, but we lack an adapted classification based on these data. The main objective of the Evaluation Intelligente de la Rétinopathie Diabétique, Intelligent evaluation of DR (EviRed) project is to develop and validate a system assisting the ophthalmologist in decision-making during DR follow-up by improving the prediction of its evolution.Methods and analysisA cohort of up to 5000 patients with diabetes will be recruited from 18 diabetology departments and 14 ophthalmology departments, in public or private hospitals in France and followed for an average of 2 years. Each year, systemic health data as well as ophthalmological data will be collected. Both eyes will be imaged by using different imaging modalities including widefield photography, optical coherence tomography (OCT) and OCT-angiography. The EviRed cohort will be divided into two groups: one group will be randomly selected in each stratum during the inclusion period to be representative of the general diabetic population. Their data will be used for validating the algorithms (validation cohort). The data for the remaining patients (training cohort) will be used to train the algorithms.Ethics and disseminationThe study protocol was approved by the French South-West and Overseas Ethics Committee 4 on 28 August 2020 (CPP2020-07-060b/2020-A01725-34/20.06.16.41433). Prior to the start of the study, each patient will provide a written informed consent documenting his or her agreement to participate in the clinical trial. Results of this research will be disseminated in peer-reviewed publications and conference presentations. The database will also be available for further study or development that could benefit patients.Trial registration numberNCT04624737
Perils and payoffs for patients in serious illness conversations as described by physicians: a qualitative study
Authors: Baxter Rebecca , Pusa Susanna , Andersson Sofia , Sandgren Anna 
Published: May 2024

BackgroundThe Serious Illness Care Programme was developed to promote more, better and earlier serious illness conversations. Conversations about goals and values are associated with improved experiences and outcomes for seriously ill patients. Clinicians’ attitudes and beliefs are thought to influence the uptake and performance of serious illness conversations, yet little is known about how clinicians perceive the impact of these conversations on patients. This study aimed to explore physicians’ perceptions regarding the impact of serious illness conversations for patients.MethodsThe Serious Illness Care Programme was implemented as a quality improvement project in two hospitals in Southern Sweden. Focus group evaluation discussions were conducted with 14 physicians and inductive thematic analysis was undertaken.ResultsThe results revealed that physicians considered potential perils and optimised potential payoffs for patients when engaging in serious illness conversations. Potential perils encompassed inappropriate timing, damaging emotions and shattering hopes. Potential payoffs included reflection time, secure space, and united understandings.ConclusionsPhysicians depicted a balance in evaluating the perils and payoffs of serious illness conversations for patients and recognised the interrelation of these possibilities through continual assessment and adjustment.
Impact of geographical cohorting, multidisciplinary rounding and incremental case management support on hospital length of stay and readmission rates: a propensity weighted analysis
Authors: Jolly Graham Aubrey , Platt Alyssa , Knutsen Kristian , Fletcher Emily , Gallagher David 
Published: May 2024

Hospital length of stay (LOS) in the USA has been increasing since the start of the COVID-19 pandemic, with numerous negative outcomes, including decreased quality of care, worsened patient satisfaction and negative financial impacts on hospitals. While many proposed factors contributing to prolonged LOS are challenging to modify, poor coordination of care and communication among clinical teams can be improved.Geographical cohorting of provider teams, patients and other clinical staff is proposed as a solution to prolonged LOS and readmissions. However, many studies on geographical cohorting alone have shown no significant impact on LOS or readmissions. Other potential benefits of geographical cohorting include improved quality of care, learning experience, communication, teamwork and efficiency.This paper presents a retrospective study at Duke University Hospital (DUH) on the General Medicine service, deploying a bundled intervention of geographical cohorting of patients and their care teams, twice daily multidisciplinary rounds and incremental case management support. The quality improvement study found that patients in the intervention arm had 16%–17% shorter LOS than those in the control arms, and there was a reduction in 30-day hospital readmissions compared with the concurrent control arm. Moreover, there was some evidence of improved accuracy of estimated discharge dates in the intervention arm.Based on these findings, the health system at DUH recognised the value of geographical cohorting and implemented additional geographically based medicine units with multidisciplinary rounds. Future studies will confirm the sustained impact of these care transformations on hospital throughput and patient outcomes, aiming to reduce LOS and enhance the quality of care provided to patients.
Swallowed topical steroid therapy for eosinophilic oesophagitis in children: practical, evidence-based guidance by the BSPGHAN Eosinophilic Oesophagitis Working Group
Authors: Chan Joseph , Flynn Diana M , Gordon Morris , Parmar Raj , Moolenschot Kerryn , Jackman Lucy , Gaynor Ed , Epstein Jenny , Cordell Amanda , Kannappan Hema , Furman Mark , Thompson Julie , Gasparetto Marco , Auth Marcus K H 
Published: May 2024

ObjectiveTo develop evidence-based guidance for topical steroid use in paediatric eosinophilic oesophagitis (pEoE) in the UK for both induction and maintenance treatment.MethodsA systematic literature review using Cochrane guidance was carried out by the British Society of Paediatric Gastroenterology, Hepatology and Nutrition (BSPGHAN) Eosinophilic Oesophagitis (EoE) Working Group (WG) and research leads to determine the evidence base for preparation, dosing and duration of use of swallowed topical steroid (STS) formulations in EoE. Seven themes relating to pEoE were reviewed by the WG, alongside the Cochrane review this formed the evidence base for consensus recommendations for pEoE in the UK. We provide an overview of practical considerations including treatment regimen and dosing. Oral viscous budesonide (OVB) and, if agreed by local regulatory committees, orodispersible budesonide (budesonide 1 mg tablets) were selected for ease of use and with most improvement in histology. A practical ‘how to prepare and use’ OVB appendix is included. Side effects identified included candidiasis and adrenal gland suppression. The use of oral systemic steroids in strictures is discussed briefly.Results2638 citations were identified and 18 randomised controlled trials were included. Evidence exists for the use of STS for induction and maintenance therapy in EoE, especially regarding histological improvement. Using the Appraisal of Guidelines, Research and Evaluation criteria, dosing of steroids by age (0.5 mg two times per day <10 years and 1 mg two times per day ≥10 years) for induction of at least 3 months was suggested based on evidence and practical consideration. Once histological remission is achieved, maintenance dosing of steroids appears to reduce the frequency and severity of relapse, as such a maintenance weaning regimen is proposed.ConclusionA practical, evidence-based flow chart and guidance recommendations with consensus from the EoE WG and education and research representatives of BSPGHAN were developed with detailed practical considerations for use in the UK.
Enhancing IgA-mediated neutrophil cytotoxicity against neuroblastoma by CD47 blockade
Authors: Chan Chilam , Stip Marjolein , Nederend Maaike , Jansen Marco , Passchier Elsemieke , van den Ham Femke , Wienke Judith , van Tetering Geert , Leusen Jeanette 
Published: May 2024

BackgroundApproximately half of the neuroblastoma patients develop high-risk neuroblastoma. Current treatment involves a multimodal strategy, including immunotherapy with dinutuximab (IgG ch14.18) targeting GD2. Despite achieving promising results, the recurrence rate remains high and poor survival persists. The therapeutic efficacy of dinutuximab is compromised by suboptimal activation of neutrophils and severe neuropathic pain, partially induced by complement activation.MethodsTo enhance neutrophil cytotoxicity, IgG ch14.18 was converted to the IgA isotype, resulting in potent neutrophil-mediated antibody-dependent cell-mediated cytotoxicity (ADCC), without complement activation. However, myeloid checkpoint molecules hamper neutrophil cytotoxicity, for example through CD47 that is overexpressed on neuroblastomas and orchestrates an immunosuppressive environment upon ligation to signal regulatory protein alpha (SIRPα) expressed on neutrophils. In this study, we combined IgA therapy with CD47 blockade.ResultsIn vitro killing assays showed enhanced IgA-mediated ADCC by neutrophils targeting neuroblastoma cell lines and organoids in comparison to IgG. Notably, when combined with CD47 blockade, both IgG and IgA therapy were enhanced, though the combination with IgA resulted in the greatest improvement of ADCC. Furthermore, in a neuroblastoma xenograft model, we systemically blocked CD47 with a SIRPα fusion protein containing an ablated IgG1 Fc, and compared IgA therapy to IgG therapy. Only IgA therapy combined with CD47 blockade increased neutrophil influx to the tumor microenvironment. Moreover, the IgA combination strategy hampered tumor outgrowth most effectively and prolonged tumor-specific survival.ConclusionThese promising results highlight the potential to enhance immunotherapy efficacy against high-risk neuroblastoma through improved neutrophil cytotoxicity by combining IgA therapy with CD47 blockade.