bluuebunny/crossref_metadata_2025_split huggingface dataset:
Do summaries of evidence enable informed decision-making about COVID-19 and influenza vaccination equitably across more and less disadvantaged groups? Study protocol for a multi-centre cluster randomised controlled trial of ‘fact boxes’ in health and social care in Germany
Authors: Ellermann Christin , Savaskan Nicolai , Rebitschek Felix G 
Published: November 2024

IntroductionEvidence summaries on the benefits and harms of treatment options support informed decisions under controlled conditions. However, few studies have investigated how such formats support decision-making across different social groups. There is a risk that only disadvantaged people will be able to make informed health decisions—possibly increasing the health equity gap. It is also unclear whether they support decision-making in the field at all. The aim of our study is to assess whether evidence summaries based on the fact box format can help people from different social groups make informed decisions about COVID-19 and influenza vaccinations, and thus reduce inequity in health communication.Methods and analysisIn a multi-centre, cluster-randomised, controlled trial, health educators from usual care and outreach work in Germany will be randomised in a 1:1 ratio to provide either usual health communication plus an evidence summary (‘fact box’) or usual health communication. Health educators provide a flyer about COVID-19 or influenza vaccination which contains a link to an online study either with (intervention) or without (control) fact box on the reverse side. Flyer and online study will be available in Arabic, German, Turkish and Russian language. The primary outcome is informed vaccination intention, based on vaccination knowledge, attitudes, intentions and behaviour. Secondary outcomes include risk perception, decisional conflict and shared decision-making. We will use linear mixed models to analyse the influence of both individual (eg, education status) and cluster level factors and account for the expected cluster variability in realising usual health communication or the intervention. The statistical analysis plan includes the selection of appropriate measures of effect size and power calculation, assuming a sample size of 800 patients.Ethics and disseminationThe trial has been approved by the Ethics Committee of the University of Potsdam, Germany (application numbers: 34/2021 and 57/2022).Results will be disseminated through peer-reviewed journals, conferences and to relevant stakeholders.Protocol versionVersion 6 (4 October 2024); Preprint available on Research Square:https://doi.org/10.21203/rs.3.rs-3401234/v3Trial registration numberNCT06076421.
Efficacy and long-term effects of the intervention of Zhan Zhuang Qigong on Pisa syndrome in Parkinson’s disease: the study protocol for a randomised control trial
Authors: Zhang Linlin , Chen Yuxiao , Zhang Yuqi , Xi Xiaoming , Bi Hongyan , Chen Pujian , Chen Fen , Wang Cheng , Huang Bin 
Published: November 2024

IntroductionPisa syndrome (PS) is a postural abnormality that frequently manifests in various neurological disorders. In recent years, the dangers associated with Parkinson’s disease (PD) and PS have been increasingly acknowledged, leading to heightened research efforts directed toward the treatment of PS. Nevertheless, the underlying causes of PS remain complex, and no clinically effective treatments have been established. While several studies have demonstrated the significant effects of Qigong in treating PD, there is currently no evidence to support the efficacy of Qigong in the treatment of PS.ObjectiveTo assess the immediate and long-term effects of Zhan Zhuang Qigong on PS in participants with PD using a rigorous randomised, parallel-control design with assignment concealment and evaluator-blinding methodologies.Methods60 PD participants meeting the inclusion criteria will be recruited and randomly assigned to one of two groups: conventional treatment (n=30) or Zhan Zhuang Qigong (n=30). The conventional treatment group will receive standard medications and physical therapy. The Zhan Zhuang Qigong group will receive conventional medicine plus 30 min of Zhan Zhuang Qigong practiced five times per week. The long-term effects of Qigong on PS will be evaluated after 6 months and 1 year of follow-up. Assessment tools will include the NeuroPostureApp, the B-PHY(A model of a balance testing system) balance check training system, the Unified Parkinson’s Disease Rating Scale and the Parkinson’s Disease Quality of Life Questionnaire, which will measure total camptocormia, upper hump degree, Pisa angles, plantar pressure distribution, motor function and quality of life in participants with PD.Ethics and disseminationThe local ethics committee approved this study (approval number: 2023-K068). The committee will oversee the study throughout its duration and will be notified of any protocol modifications. The results of the study will be disseminated through publication in an international journal or presentation at a conference.Trial registration numberChiCTR2400079696.
Effectiveness of non-pharmacological interventions for pain management in patients with cancer:a protocol for systematic review and network meta-analysis
Authors: Ye Lu , Li Yun-Hua , Huang Yu-He , Deng Qing Chuan , Huang Yu-Xin , Peng Yun-Han , Li Da 
Published: November 2024

IntroductionPain management in patients with cancer is a critical aspect of oncological care, yet remains challenging with current pharmacological therapies. Non-pharmacological interventions, offering potential benefits without the adverse effects of drugs, have gained attention. However, the effectiveness of these diverse non-pharmacological interventions is not well understood, creating a gap in clinical practice. This study aims to conduct a systematic review and network meta-analysis (NMA) to evaluate the efficacy of various non-pharmacological interventions for pain management in patients with cancer, providing evidence-based guidance for clinicians and patients.Methods and analysisA systematic review and Bayesian NMA will be performed. To assess the efficacy of interventions for cancer pain, we will search six electronic databases: Cochrane Library, Web of Science, PubMed, EMBASE, PsycINFO and the Cumulative Index to Nursing and Allied Health Literature, focusing on identifying randomised controlled trials. Literature screening should be independently performed by two reviewers. A NMA will evaluate the efficacy of various non-pharmacological interventions for cancer pain. A second NMA will compare the efficacy of different non-pharmacological interventions in relieving pain interference in patients with cancer pain. Bayesian 95% credible intervals will be used to estimate the pooled mean effect size for each treatment, and the surface under the cumulative ranking area will be employed to rank the effectiveness of the treatments.Ethics and disseminationEthical approval is not required for this systematic review of the published data. Findings will be disseminated via peer-reviewed publication.PROSPERO registration numberCRD42024483025.
Safety of diagnostic hysteroscopy for the investigation of type II endometrial cancer: systematic review with meta-analysis
Authors: Yang Wenmei , Zhao Xiaoqi , Pan Jingyi , Zhi Zhifu 
Published: November 2024

AimThe goal of this study is to evaluate the safety of diagnostic hysteroscopy (HSC) in type II endometrial cancer (EC).MethodsWe searched PubMed, the Cochrane Library and the Chinese Medical Journal Full-Text Database until December 2023. Eligible trials were all cohort studies in which patients were allocated to diagnostic HSC group or dilation and curettage (D&C) group. Quality assessments of eligible studies were performed using the Newcastle–Ottawa scales. Risk ratios (RRs) with 95% CIs were calculated as a measure of effects.ResultsThree trials were included in our analysis, which were all retrospective cohort studies. 696 patients with histologically proven type II EC were allocated to HSC or D&C before surgery. 257 patients underwent preoperative HSC, and 439 patients underwent D&C. The positive peritoneal cytology rate did not statistically differ between the groups (RR, 1.9; 95% CI, 1.00 to 3.61; p=0.05). There was no significant difference in the incidence of International Federation of Gynecology and Obstetrics (FIGO) stage between the HSC and D&C groups (stage I/II: RR, 1.08; 95% CI, 0.95 to 1.24; p=0.25; stage III/IV: RR, 0.82; 95% CI, 0.62 to 1.09; p=0.18). There was no significant difference in recurrence between the HSC and D&C groups (RR, 0.92; 95% CI, 0.66 to 1.32; p=0.66); the heterogeneity of the two included studies was acceptable (p=0.54, I2=0%).ConclusionsPreoperative HSC in patients with type II EC does not increase the risk for cancer cell dissemination within the peritoneal cavity. Preoperative HSC does not progress the FIGO staging in patients with type II EC and does not increase the risk of tumour recurrence. There is no reason to avoid HSC for the diagnosis of type II EC currently. However, type II tumours generally are less well differentiated and have poorer prognoses than type I tumours. More prospective and adequately powered trials are required to clarify whether preoperative HSC in patients with type II EC is safe.
Living systematic review and comprehensive network meta-analysis of ALS clinical trials: study protocol
Authors: Van Loon Floris T , Seitidis Georgios , Mavridis Dimitris , van Unnik Jordi W J , Weemering Daphne N , van den Berg Leonard H , Bethani Ilianna , Nikolakopoulos Stavros , van Eijk Ruben P A 
Published: November 2024

IntroductionAmyotrophic lateral sclerosis (ALS) is a fatal neurogenerative disease with no effective treatment to date. Despite numerous clinical trials, the majority of studies have been futile in their effort to significantly alter the course of the disease. However, these studies may still provide valuable information for identifying patient subgroups and generating new hypotheses for future research. Additionally, synthesising evidence from these studies may help overcome the limitations of individual studies. Network meta-analysis may refine the assessment of efficacy in specific patient subgroups, evaluate intervention characteristics such as mode of administration or biological mechanisms of action, and rank order promising therapeutic areas of interest. Therefore, we aim to synthesise the available evidence from ALS clinical trials.Methods and analysisWe will conduct a systematic review to identify all clinical trials that assessed disease-modifying pharmaceutical therapies, cell therapies, or supplements in patients with ALS. Outcomes of interest are clinical disease progression outcomes and survival. We will conduct this search in the period Q4 2024 in three databases: PubMed, Embase and ClinicalTrials.gov for studies from 1999 to 2023. Individual patient data and aggregate data will be collected and subsequentially synthesised in meta-analytical models. The final model will be presented as an open-source web application with biannual updates of the underlying data, thereby providing a ‘living’ overview of the ALS clinical trial landscape.Ethics and disseminationNo ethics approvals are required. Findings will be presented at relevant conferences and submitted to peer-reviewed journals. Data will be stored anonymously in secure repositories.
Evaluating the impact of needs assessment models on autistic children’s participation in the habilitation process: protocol for a prospective observational study
Authors: Lundqvist Lars-Olov , Sjödin Linda , Karvonen Evelina , Arnell Susann 
Published: November 2024

IntroductionThe rising prevalence of autism spectrum disorder (ASD) among children poses significant challenges for healthcare services. Research has underscored the crucial role of children’s involvement in their healthcare. However, due to the intricate nature of ASD, marked by communication and social interaction differences, healthcare providers face challenges in tailoring their services to accommodate these children. This project aims to explore the impact of two distinct needs assessment models on children’s participation in the needs assessment process.Methods and analysisWe will conduct a prospective observational study comparing responses from children subjected to two different needs assessment procedures: survey-based and meeting-based. Supplementary data will be collected from the children’s parents/guardians and healthcare professionals. Data collection methods will include questionnaires, interviews and document analysis of individual habilitation plans. We aim to recruit 120 children aged 7–17 diagnosed with ASD but without intellectual disability, with 60 undergoing the survey-based needs assessment and 60 undergoing the meeting-based assessment. The primary outcome measure will be the perception of participation in the needs assessment procedure. Secondary outcomes will include the children’s quality of life and mental health; the parents’ knowledge of their child’s strengths, abilities and special needs; and the parents’ perception of the quality of collaboration with the healthcare team.Ethics and disseminationThe study received ethics approval from the Swedish Ethical Review Authority on 4 March 2024 (reference number 2024-00227-01). All children and their caregivers will receive both verbal and written information about the study before being asked to provide written informed consent to participate. The findings will be disseminated through publication in peer-reviewed journals and presentation at conferences. Additionally, a popular science report summarising the data and its interpretation will be published.Trial registration numberNCT06381856.
Correlation between illness perceptions and self-reported degree-of-worry in somatic ill patients in emergency care: a Danish cross-sectional study
Authors: Jensen Andrea Nedergaard , Kallemose Thomas , Frostholm Lisbeth , Gamst-Jensen Hejdi 
Published: November 2024

Objectives
The study aimed to investigate the correlation between illness perceptions and self-reported degree-of-worry (DOW) in patients presenting to the emergency department with acute somatic illness.

Design
A cross-sectional survey study collected data from a survey on DOW, the Brief-illness Perception Questionnaire (B-IPQ) and demographics.

Setting
An emergency department at a university hospital in the Capital Region of Denmark.

Participants
944 patients (≥18 years) presenting to the emergency department with acute somatic illness. Data collection was conducted during day and evening shifts on weekdays from 13 January to 19 December 2020.

Methods

Correlations between B-IPQ scores and DOW, including (1) the total B-IPQ score, (2) emotional representations (emotion and illness concern combined) and (3) the single items, respectively.
Secondary analysis
: linear relationships between the single B-IPQ items and DOW. Analyses included the variables sex, age, reason for contact, self-reported comorbidity, employment, highest educational attainment, cohabitation status and region of origin.

Results
The study found moderate correlations between the total illness perceptions score and DOW of 0.47 (95% CI 0.42 to 0.52) and emotional representations and DOW of 0.57 (95% CI 0.52 to 0.61). Linear regression showed the largest and most significant changes in DOW with an increasing score of the B-IPQ items for consequence, illness concern and emotion.

Conclusion
Illness perceptions overall and perceptions of consequences of symptoms, illness concern and emotional representations are correlated with patients’ DOW, with increasing DOW related to more negative illness perceptions. This finding contributes to insight into how illness perceptions are related to illness worry when presenting to the emergency department. Incorporating the novel DOW scale may aid triage and clinical encounters in the emergency department.

Study registration

ClinicalTrails.gov reference:
NCT04226040
.
Augmentation of cognitive-behavioural therapy for obsessive-compulsive and anxiety disorders: a protocol for a systematic review and meta-analysis
Authors: Torbecke Jonathan , Langhammer Till , Mewes Lisa , Lueken Ulrike , Fendel Johannes Caspar 
Published: November 2024

IntroductionWhile cognitive-behavioural therapy (CBT) for obsessive-compulsive disorder (OCD) and anxiety disorders (ADs) has been proven to be effective and is commonly recommended, a considerable proportion of patients remain symptomatic, do not respond to treatment or discontinue it. Thus, augmentation strategies aimed at enhancing CBT outcomes are essential to reduce the burden of OCD and ADs on patients and society. Various augmentation strategies for CBT in OCD and ADs have been investigated, yet it remains unclear if they show robust beneficial effects beyond first-line CBT. With this systematic review and meta-analysis, we will provide an overview and critically assess the efficacy of non-pharmacological augmentation strategies in addition to first-line CBT treatment for symptom reduction, response rates and dropout rates in individuals with OCD or ADs.Methods and analysisWe will screen PubMed, Embase, PsycArticles, PsycInfo, CINAHL, PSYNDEX and Cochrane Register of Controlled Trials without restrictions on publication dates or languages. Additionally, forward, and backward searches of included studies and systematic reviews will be conducted. Two reviewers will independently screen the studies, extract data and assess the methodological quality of the studies. We will exclusively include randomised controlled trials. The primary outcomes will be symptom severity and response rates. Dropout rates will serve as a secondary outcome. Moreover, we will provide a narrative review of the results. We will use subgroup and meta-regression analyses to identify potential moderators and sources of between-study heterogeneity. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the overall quality of evidence.Ethics and disseminationEthical approval is not required. Results will be published in a peer-reviewed journal.PROSPERO registration numberCRD42024561027.
Impact of the COVID-19 pandemic on maternal, neonatal and child health service utilisation, delivery and health outcomes in Gauteng province, South Africa: an interrupted time series (ITS) analysis
Authors: Fonka Cyril Bernsah , Khamisa Natasha , Worku Eshetu , Blaauw Duane 
Published: November 2024

BackgroundGauteng was one of the provinces in South Africa most hit by COVID-19. However, there has been no assessment of the pandemic’s impact on essential maternal, neonatal and child health (MNCH) services in Gauteng, for planning against future emergencies. This study sought to assess the impact of the COVID-19 pandemic on essential MNCH service utilisation, delivery and health outcomes in Gauteng province.MethodsWe employed a quasi-experimental interrupted time series (ITS) study design, using the District Health Information System (DHIS) data set to evaluate the impact of COVID-19 on eight key MNCH indicators between March 2019 to February 2021. Using Stata V.17.0 and 5% alpha, a segmented linear regression (ITS) model quantified the trends of the indicators before COVID-19 (March 2019 to February 2020) (β1), the immediate change in level due to the March 2020 lockdown (β2), the post-lockdown (March 2020 to February 2021) trend (β4) and the change in gradient from before to after the lockdown (β3).ResultsCOVID-19 lockdown exerted a significant decline in primary healthcare headcount<5 years (n) (β2= −60 106.9 (95% CI, −116 710.4; −3503.3), p=0.039); and postnatal care visits within 6 days (rate) (β2=−8.2 (95% CI, −12.4; −4.1), p=0.001). Antenatal care first visits before 20 weeks (rate) declined during COVID-19 (β3=−0.4 (95% CI, −0.7; −0.1), p=0.013) compared with the pre-COVID-19 period. COVID-19 adverse effects on service delivery (measles second dose coverage and fully immunised<1 year) and health outcomes (facility deaths 0–6 days, maternal mortality ratio and pneumonia case fatality<1 year) were insignificant. While some indicators post-lockdown attempted to recover, others deteriorated.ConclusionIn Gauteng province, the COVID-19 pandemic significantly disrupted essential MNCH service utilisation, particularly during the March 2020 lockdown. The mechanism of MNCH service disruption by COVID-19 was induced by both supply and demand services. It is imperative to strike a balance between maintaining routine healthcare services and managing an outbreak.
Decision analytical modelling of strategies for investigating suspected acute aortic syndrome
Authors: Thokala Praveen , Goodacre Steve , Cooper Graham , Hinchliffe Robert , Reed Matthew J , Thomas Steven , Wilson Sarah , Fowler Catherine , Lechene Valérie 
Published: November 2024

BackgroundAcute aortic syndrome (AAS) requires urgent diagnosis with computed tomographic angiography (CTA). Diagnostic strategies need to weigh the benefits of detecting AAS against the costs of using CTA with a low yield of AAS when the prevalence of AAS is low. We aimed to estimate the cost-effectiveness of diagnostic strategies using clinical probability scoring and D-dimer to select patients with potential symptoms of AAS for CTA.MethodsWe developed a decision analytical model to simulate the management of patients attending hospital with possible AAS. We modelled diagnostic strategies that used the Aortic Dissection Detection Risk Score (ADD-RS) and D-dimer to select patients for CTA. We used estimates from our meta-analysis, existing literature and clinical experts to model the consequences of diagnostic strategies on survival, health utility, and health and social care costs. We estimated the incremental cost per quality-adjusted life-years gained by each strategy compared with the next most effective alternative on the efficiency frontier.ResultsA strategy based on the Canadian guideline (CTA if ADD-RS>1 or ADD-RS=1 with D-dimer >500 ng/mL) is cost-effective but would result in high rates of CTA if applied to an unselected population (AAS prevalence 0.26%). The strategy is also cost-effective and would result in lower rates of CTA if applied to a more selected population, such as those with a non-zero clinical suspicion of AAS (prevalence 0.61%). For patients currently receiving CTA, using ADD-RS>1 or D-dimer >500 ng/mL to select patients for CTA is cost-effective.ConclusionsA strategy using ADD-RS>1 or ADD-RS=1 with D-dimer >500 ng/mL to select patients for CTA appears cost-effective but primary research is required to evaluate this strategy in practice and determine how suspicion of AAS is identified.