bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy of positive psychotherapy in reducing negative and enhancing positive psychological outcomes: a meta-analysis of randomised controlled trials
Authors: Hoppen Thole Hilko , Morina Nexhmedin 
Published: September 2021

ObjectivePositive psychotherapy (PPT) aims at increasing positive affect, meaning and engagement. We aimed to synthesise the available evidence on PPT efficacy.DesignWe conducted a preregistered systematic literature search and meta-analysis of randomised controlled trials examining the efficacy of PPT for increasing positive (eg, satisfaction with life) or decreasing negative psychological outcomes (eg, depression).Data sourcesMedline, PsycINFO and Web of Science from 2006 (ie, inception of PPT) to February 2020 as well as related systematic reviews and meta-analyses.ResultsWe included 20 randomised controlled trial with a total of 1360 participants. Moderate effect sizes were found for increasing positive outcomes (g=−0.72, 95% CI: −1.31 to −0.14, k=10, numbers needed to treat (NNT)=2.55) and reducing negative outcomes (g=0.48, 95% CI: 0.18 to 0.78, k=8, NNT=3.76) when PPT was compared with waitlist control conditions at post-treatment assessment. When compared with active control conditions, PPT yielded large effect sizes for increasing positive outcomes (g=−0.92, 95% CI: −1.74 to −0.11, k=6, NNT=2.05) and reducing depression (g=0.94, 95% CI: 0.18 to 1.70, k=6, NNT=2.03) at post-treatment assessment. No significant differences in efficacy were found when compared with established treatments such as cognitive–behavioural therapy. Evidence was found to support an association between trial quality and effect sizes. For positive outcomes, higher trial quality was related to larger effect size. Whereas higher trial quality was associated with smaller effect size for depression. Follow-up assessments remained too scarce for most planned analyses.ConclusionsOur findings support the short-term efficacy of PPT. However, results are to be regarded with due caution in the light of low number of trials. More high-quality trials that assess efficacy at follow-ups are needed to draw firmer conclusions on the long-term efficacy of PPT.PROSPERO registration numberCRD42020173567.
Characterising fetal alcohol spectrum disorder in Canada: a national database protocol study
Authors: Cook Jocelynn , Unsworth Kathy , Flannigan Katherine 
Published: September 2021

IntroductionFetal alcohol spectrum disorder (FASD) is one of the most common neurodevelopmental disorders in North America. It is a complex disability, associated with challenges in cognitive, behavioural and socialemotional functioning, as well as an increased risk of physical and mental health comorbidities, and difficulties in daily living across the lifespan. Previous attempts to characterise the profile of this population have been hampered by differences in data collected across studies, regional discrepancies in terminology and definitions, and a lack of tools to integrate comprehensive datasets.Methods and analysisThe goals of this study are to use the Canadian National FASD Database, a national repository of FASD assessment-related information, to better understand the functional profile, comorbidities, intervention needs and difficulties in daily living experienced by individuals assessed for FASD across the lifespan. We will also examine what factors may be the most sensitive predictors of receiving an FASD diagnosis. Data will be analysed from over 3500 records collected between 2010 and 2021 (ongoing) from 26 FASD diagnostic clinics in seven provinces and territories. Data collection is ongoing, and analysis will be performed on a biannual basis to continue to hone our understanding of the profiles, needs and outcomes of individuals assessed for FASD in Canada. This research is critical for refining FASD assessment and diagnostic practice, enabling accurate and early identification of individuals with FASD, and connecting individuals with FASD and their families to comprehensive and effective services and resources to support healthy developmental trajectories.Ethics and disseminationEthics approval for the National FASD Database Project was obtained from the Ottawa Health Science Network Research Ethics Board. As new knowledge is gained from this project, findings will be disseminated through publications, presentations and feedback to participating clinics, with the ultimate goal of informing FASD research, practice and policy.
Predictors of district nursing care utilisation for community-living people in the Netherlands: an exploratory study using claims data
Authors: Veldhuizen Jessica Desirée , Mikkers Misja Chiljon , Schuurmans Marieke J , Bleijenberg Nienke 
Published: September 2021

ObjectiveTo explore predictors of district nursing care utilisation for community-living (older) people in the Netherlands using claims data. To cope with growing demands in district nursing care, knowledge about the current utilisation of district nursing care is important.SettingDistrict nursing care as a part of primary care.ParticipantsIn this nationwide study, claims data were used from the Dutch risk adjustment system and national information system of health insurers. Samples were drawn of 5500 pairs of community-living people using district nursing care (cases) and people not using district nursing care (controls) for two groups: all ages and aged 75+ years (total N=22 000).Outcome measuresThe outcome was district nursing care utilisation and the 114 potential predictors included predisposing factors (eg, age), enabling factors (eg, socioeconomic status) and need factors (various healthcare costs). The random forest algorithm was used to predict district nursing care utilisation. The performance of the models and importance of predictors were calculated.ResultsFor the population of people aged 75+ years, most important predictors were older age, and high costs for general practitioner consultations, aid devices, pharmaceutical care, ambulance transportation and occupational therapy. For the total population, older age, and high costs for pharmaceutical care and aid devices were the most important predictors.ConclusionsPeople in need of district nursing care are older, visit the general practitioner more often, and use more and/or expensive medications and aid devices. Therefore, close collaboration between the district nurse, general practitioner and the community pharmacist is important. Additional analyses including data regarding health status are recommended. Further research is needed to provide an evidence base for district nursing care to optimise the care for those with high care needs, and guide practice and policymakers’ decision-making.
Effect of melatonin and melatonin agonists on postoperative sleep quality in adult patients: a protocol for systematic review and meta-analysis with trial sequential analysis
Authors: Tsukinaga Akito , Mihara Takahiro , Takeshima Teppei , Tomita Makoto , Goto Takahisa , Yamanaka Takeharu 
Published: September 2021

IntroductionThe circadian rhythm of melatonin secretion is disturbed after general anaesthesia, leading to postoperative sleep disturbance. Small studies investigating the preventive effect of melatonin administration on postoperative sleep disturbance have not reached any conclusions. Therefore, we will conduct a systematic review and meta-analysis to obtain conclusive results.Methods and analysisWe prepared this protocol following the 2015 Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols guidelines. We will conduct a search for randomised controlled trials that evaluated the effect of melatonin and melatonin agonists on postoperative sleep quality in adult patients undergoing general anaesthesia or regional anaesthesia with sedation. We will exclude patients undergoing regional anaesthesia without sedation. Relevant studies will be searched in the following eight databases: MEDLINE, the Cochrane Central Register of Controlled Trials, Embase, Web of Science and four preregistration sites from inception to 1 January 2021. No language restrictions will be applied. Two authors will independently scan and select eligible studies and perform data extraction and assessment of the risk of bias. The Visual Analogue Scale scores for sleep quality will be combined as the mean difference with a 95% CI using a random-effect model; we will use I2to assess heterogeneity. We will evaluate the quality of trials using the Cochrane methodology and assess the quality of evidence using the Grading of Recommendation Assessment, Development and Evaluation approach. If appropriate, trial sequential analysis will be performed.Ethics and disseminationNo ethical approval is required for this meta-analysis, as it does not include individual patient data. We will disseminate the results of this meta-analysis in a peer-reviewed journal.PROSPERO registration numberCRD42020180167.
Outcomes evaluating quality of life and their measurement properties in early-onset scoliosis: protocol for a systematic review
Authors: Baird Charles , Archer James , Gardner Adrian , Rushton Alison B , Heneghan Nicola R 
Published: September 2021

IntroductionEarly-onset scoliosis (EOS) is a rare spinal deformity affecting children under the age of 10. Both the condition and its treatment have associated morbidity and can impact quality of life. Understanding this impact can be achieved by using appropriate patient-reported and/or carer-reported outcome measures. The aim of the review described in this protocol is to evaluate the evidence on measurement properties relevant to health-related quality of life outcomes in the EOS population. The focus will be on outcome measures relevant to patients undergoing treatment of EOS under the age of 10.Methods/analysisThis protocol is reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol and COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) methodology. The MEDLINE, EMBASE, EMCARE, PubMed, PsychINFO and CINAHL databases will be searched using a two-stage search strategy. The first stage will identify measures of HRQoL used in EOS through screening of titles and abstracts. The second stage will assess the measurement properties of those measures identified through screening of full-text articles. The measurement properties of interest are the ‘reliability’, ‘validity’ and ‘responsiveness’ of the instrument. Only English language articles will be considered. Two reviewers will independently review the search results against the eligibility criteria, perform data extraction and assess for risk of bias, with disputes handled by a third reviewer. Data will be quantitatively pooled where possible or reported as a narrative synthesis. The summarised results for each measurement property will be rated against the criteria for good measurement properties following the COSMIN methodology. Two reviewers will assess the body of evidence for each measurement property using modified Grading of Recommendations, Assessment, Development and Evaluation guidelines.Ethics and disseminationNo ethical approval is required for this review and the results will be submitted for publication in peer-reviewed publications.PROSPERO registration numberCRD42020219721.
Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT)
Authors: Pal Abhijit , Stapleton Sarah , Yap Christina , Lai-Kwon Julia , Daly Robert , Magkos Dimitrios , Baikady Bindumalini Rao , Minchom Anna , Banerji Udai , De Bono Johann , Karikios Deme , Boyle Frances , Lopez Juanita 
Published: September 2021

IntroductionEarly phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures—this is reflected in the increasing length of participant information sheets (PIS). Informed consent for early phase clinical trials has been contentious due to the potential ethical issues associated with performing experimental research on a terminally ill population which has exhausted standard treatment options. Empirical studies have demonstrated significant gaps in patient understanding regarding the nature and intent of these trials. This study aims to test whether enhanced informed consent for patient education can improve patient scores on a validated questionnaire testing clinical trial comprehension.Methods and analysisThis is a randomised controlled trial that will allocate patients who are eligible to participate in one of four investigator-initiated clinical trials at the Royal Marsden Drug Development Unit to either a standard arm or an experimental arm, stratified by age and educational level. The standard arm will involve the full length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A and B (QuIC-A and QuIC-B). The experimental arm will involve the full length trial PIS, exposure to a two-page study aid and 10 online educational videos, followed by administration of the QuIC-A and QuIC-B. The primary endpoint will be the difference (using a one-sided two-sample t-test) in the QuIC-A score, which measures objective understanding, between the standard and experimental arm. Accrual target is at least 17 patients per arm to detect an 8 point difference (80% power, alpha 0.05).Ethics and disseminationEthics approval was granted by the National Health Service Health Research Authority on 15 June 2020—IRAS Project ID 277065, Protocol Number CCR5165, REC Reference 20/EE/0155. Results will be disseminated via publication in a relevant journal.Trial registration numberNCT04407676; Pre-results.
Cost-effectiveness analysis of different screening strategies for colorectal cancer in Guangzhou, southern China: a Markov simulation analysis based on natural community screening results
Authors: Zhou Qin , Li Hai-lin , Li Yan , Gu Yu-ting , Liang Ying-ru , Liu Hua-zhang , Li Ke , Dong Hang , Chen Yuan-yuan , Lin Guo-zhen 
Published: September 2021

ObjectivesTo evaluate the cost-effectiveness of four different primary screening strategies: high-risk factor questionnaire (HRFQ) alone, single immunochemical faecal occult blood test (iFOBT), double iFOBT and HRFQ+double iFOBT for colorectal cancer (CRC) screening compared with no screening using the Markov model.MethodsTreeage Pro V.2011 software was used to simulate the Markov model. The incremental cost-effectiveness ratio, which was compared with the willingness-to-pay (WTP) threshold, was used to reflect the cost-effectiveness of the CRC screening method. One-way sensitivity analysis and probabilistic sensitivity analysis were used for parameter uncertainty.ResultsAll strategies had greater effectiveness because they had more quality-adjusted life years (QALYs) than no screening. When the WTP was ¥435 762/QALY, all screening strategies were cost-effective compared with no screening. The double iFOBT strategy was the best-buy option compared with all other strategies because it had the most QALYs and the least cost. One-way sensitivity analysis showed that the sensitivity of low-risk adenoma, compliance with colonoscopy and primary screening cost were the main influencing factors comparing single iFOBT, double iFOBT and HRFQ+double iFOBT with no screening. However, within the scope of this study, there was no fundamental impact on cost-effectiveness. Probabilistic sensitivity analysis showed that when the WTP was ¥435 762/QALY, the probabilities of the cost-effectiveness acceptability curve with HRFQ alone, single iFOBT, double iFOBT and HRFQ+double iFOBT were 0.0%, 5.3%, 69.3% and 25.4%, respectively.ConclusionsAll screening strategies for CRC were cost-effective compared with no screening strategy. Double iFOBT was the best-buy option compared with all other strategies. The significant influencing factors were the sensitivity of low-risk polyps, compliance with colonoscopy and cost of primary screening.
Which strategy for using medical and community masks? A prospective analysis of their environmental impact
Authors: Bouchet Alexandre , Boucher Julien , Schutzbach Kevin , Senn Nicolas , Genton Blaise , Vernez David 
Published: September 2021

IntroductionThe use of personal protective equipment, especially medical masks, increased dramatically during the COVID-19 crisis. Medical masks are made of synthetic materials, mainly polypropylene, and a majority of them are produced in China and imported to the European market. The urgency of the need has so far prevailed over environmental considerations.ObjectiveAssess the environmental impact of different strategies for the use of face mask.MethodA prospective analysis was conducted to assess the environmental impact of different strategies for the use of medical and community masks. Eight scenarios, differentiating the typologies of masks and the modes of reuse are compared using three environmental impact indicators: the Global Warming Potential (GWP100), the ecological scarcity (UBP method, from German ‘Umweltbelastungpunkte’) and the plastic leakage (PL). This study attempts to provide clear recommendations that consider both the environmental impact and the protective effectiveness of face masks used in the community.ResultsThe environmental impact of single-use masks is the most unfavourable, with a GWP of 0.4–1.3 kg CO2eq., depending on the transport scenario, and a PL of 1.8 g, for a 1 month protection against COVID-19. The use of home-made cotton masks and prolonged use of medical masks through wait-and-reuse are the scenarios with the lowest impact.ConclusionThe use of medical masks with a wait and reuse strategy seems to be the most appropriate when considering both environmental impact and effectiveness. Our results also highlight the need to develop procedures and the legal/operational framework to extend the use of protective equipment during a pandemic.
Risk of harm in synthetic and biological intervention trials in patients with inflammatory arthritis: protocol for a metaepidemiological study focusing on contextual factors
Authors: Malm Esben , Nielsen Sabrina Mai , Berg Johannes , Ioannidis John P. A. , Furst Daniel , Smolen Josef S. , Taylor Peter C. , Kristensen Lars Erik , Tarp Simon , Ellingsen Torkell , Christensen Robin 
Published: September 2021

IntroductionInflammatory arthritis (IA) conditions, including rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, are characterised by inflammatory infiltration of the joints. Biological disease-modifying antirheumatic drugs (bDMARDs) and targeted synthetic disease-modifying antirheumatic drugs (tsDMARDs), respectively, reduce the effects of proinflammatory cytokines and immune cells to ameliorate disease. However, immunosuppression can be associated with high rates of serious adverse events (SAEs), including serious infections, and maybe an increased risk of malignancies and cardiovascular events. Currently, there is no empirical evidence on the extent to which contextual factors and risk of bias (RoB) domains may modify these harm signals in randomised trials.Methods and analysisWe will search MEDLINE (via PubMed) for systematic reviews published since April 2015 and all Cochrane reviews. From these reviews, randomised trials will be eligible if they include patients with an IA condition with at least one group randomly allocated to bDMARD and/or tsDMARD treatments. A predefined form will be used for extracting data on population characteristics (eg, baseline characteristics or eligibility criteria, such as medication background) and specific harm outcome measures, such as number of withdrawals, numbers of patients discontinuing due to adverse events and number of patients having SAEs. RoB in individual trials will be assessed using a modified Cochrane RoB tool. We will estimate the potentially causal harm effects related to the experimental intervention compared with control comparator as risk ratios, and heterogeneity across randomised comparisons will be assessed statistically and evaluated as inconsistency using the I2Index. Our metaregression analyses will designate population and trial characteristics and each RoB domain as independent variables, whereas the three harm domains will serve as dependent variables.Ethics and disseminationEthics approval is not required for this study. Results will be disseminated through publication in international peer-reviewed journals.PROSPERO registration numberCRD42020171124.
Relapse prevention group therapy via video-conferencing for substance use disorder: protocol for a multicentre randomised controlled trial in Indonesia
Authors: Yamada Chika , Siste Kristiana , Hanafi Enjeline , Ophinni Youdiil , Beatrice Evania , Rafelia Vania , Alison Peter , Limawan Albert , Shinozaki Tomohiro , Matsumoto Toshihiko , Sakamoto Ryota 
Published: September 2021

BackgroundSubstance use disorder (SUD) is a leading contributor to the global burden of disease. In Indonesia, the availability of formal treatment for SUD falls short of the targeted coverage. A standardised therapeutic option for SUD with potential for widespread implementation is required, yet evidence-based data in the country are scarce. In this study, we developed a cognitive behavioural therapy (CBT)-based group telemedicine model and will investigate effectiveness and implementability in a multicentre randomised controlled trial.MethodsA total of 220 participants will be recruited from the social networks of eight sites in Indonesia: three hospitals, two primary healthcare centres and three rehabilitation centres. The intervention arm will participate in a relapse prevention programme called the Indonesia Drug Addiction Relapse Prevention Programme (Indo-DARPP), a newly developed 12-week module based on CBT and motivational interviewing constructed in the Indonesian context. The programme will be delivered by a healthcare provider and a peer counsellor in a group therapy setting via video-conferencing, as a supplement to participants’ usual treatments. The control arm will continue treatment as usual. The primary outcome will be the percentage increase in days of abstinence from the primarily used substance in the past 28 days. Secondary outcomes will include addiction severity, quality of life, motivation to change, psychiatric symptoms, cognitive function, coping, and internalised stigma. Assessments will be performed at baseline (week 0), post-treatment (week 13), and 3 and 12 months post-treatment completion (weeks 24 and 60). Retention, participant satisfaction, and cost-effectiveness will be assessed as the implementation outcomes.Ethics and disseminationThe study protocol was reviewed and approved by the Ethics Committees of Universitas Indonesia and Kyoto University. The results will be disseminated via academic journals and international conferences. Depending on trial outcomes, the treatment programme will be advocated for adoption as a formal healthcare-based approach for SUD.Trial registration numberUMIN000042186.