bluuebunny/crossref_metadata_2025_split huggingface dataset:
Interpretation of change scores for the National Eye Institute Visual Function Questionnaire-25: the minimally important difference
Authors: Burr Jennifer M , Cooper David , Ramsay Craig R , Che Hamzah Jemaima , Azuara-Blanco Augusto 
Published: May 2021

AimTo estimate the minimally important difference (MID) in change in National Eye Institute Visual Function Questionnaire-25 (VFQ-25) composite score using methods aligned with patient perception.MethodsRetrospective analysis of prospectively collected data from adults with primary angle closure or primary angle closure glaucoma enrolled in the Effectiveness, in Angle-closure Glaucoma, of Lens Extraction study. We included data from 335 participants with patient reported visual function (VFQ-25) and health status measured by the EQ-5D-3L over 36 months. We used the recommended anchor-based methods (receiver operating characteristic (ROC), predictive modelling and mean change) to determine the MID of the VFQ-25. EQ-5D-3L anchor change was defined as none (<0.065); minimal (0.065≤EQ-5D-3L change ≤0.075 points) and greater change (>0.075 points).ResultsMean baseline VFQ-25 score was 87.6 (SD 11.8). Estimated MIDs in the change in VFQ-25 scores (95% CI) were 10.5 (1.9 to 19.2); 3.9 (−2.3 to 10.1); 5.8 (1.9 to 7.2) and 8.1 (1.7 to 14.8) for the ‘within-patient’, ‘between-patient’ change, ROC and predictive modelling anchor methods respectively. Excluding estimates from the methodologically weaker ‘within-patient’ method, the MID of a change in VFQ-25 composite score is 5.8 (median value).ConclusionsEstimates of the MID using multiple methods assist in the interpretation of the VFQ scores. In the context of early glaucoma related visual disability, a change score of around six points on the VFQ-25 is likely to be important to patients. Further confirmatory research is required. Studies comparing changes in patient-reported outcome measure scores with a global measure of patients’ perceived change are required.
Three-year results of phase I retinal gene therapy trial for CNGA3-mutated achromatopsia: results of a non randomised controlled trial
Authors: Reichel Felix Friedrich , Michalakis Stylianos , Wilhelm Barbara , Zobor Ditta , Muehlfriedel Regine , Kohl Susanne , Weisschuh Nicole , Sothilingam Vithiyanjali , Kuehlewein Laura , Kahle Nadine , Seitz Immanuel , Paquet-Durand Francois , Tsang Stephen H , Martus Peter , Peters Tobias , Seeliger Mathias , Bartz-Schmidt Karl Ulrich , Ueffing Marius , Zrenner Eberhard , Biel Martin , Wissinger Bernd , Fischer Dominik 
Published: May 2021

AimsTo determine long-term safety and efficacy outcomes of a subretinal gene therapy for CNGA3-associated achromatopsia. We present data from an open-label, nonrandomised controlled trial (NCT02610582).MethodsDetails of the study design have been previously described. Briefly, nine patients were treated in three escalating dose groups with subretinal AAV8.CNGA3 gene therapy between November 2015 and October 2016. After the first year, patients were seen on a yearly basis. Safety assessment constituted the primary endpoint. On a secondary level, multiple functional tests were carried out to determine efficacy of the therapy.ResultsNo adverse or serious adverse events deemed related to the study drug occurred after year 1. Safety of the therapy, as the primary endpoint of this trial, can, therefore, be confirmed. The functional benefits that were noted in the treated eye at year 1 were persistent throughout the following visits at years 2 and 3. While functional improvement in the treated eye reached statistical significance for some secondary endpoints, for most endpoints, this was not the case when the treated eye was compared with the untreated fellow eye.ConclusionThe results demonstrate a very good safety profile of the therapy even at the highest dose administered. The small sample size limits the statistical power of efficacy analyses. However, trial results inform on the most promising design and endpoints for future clinical trials. Such trials have to determine whether treatment of younger patients results in greater functional gains by avoiding amblyopia as a potential limiting factor.
Behavioral interventions to improve population health outreach for hepatitis C screening: randomized clinical trial
Authors: Mehta Shivan J , Day Susan C , Norris Anne H , Sung Jessica , Reitz Catherine , Wollack Colin , Snider Christopher K , Shaw Pamela A , Asch David A 
Published: May 2021

Abstract

Objective
To evaluate whether opt out framing, messaging incorporating behavioral science concepts, or electronic communication increases the uptake of hepatitis C virus (HCV) screening in patients born between 1945 and 1965.

Design
Pragmatic randomized controlled trial.

Setting
43 primary care practices from one academic health system (Philadelphia, PA, USA) between April 2019 and May 2020.

Participants
Patients born between 1945 and 1965 with no history of screening and at least two primary care visits in the two years before the enrollment period.

Interventions
This multilevel trial was divided into two studies. Substudy A included 1656 eligible patients of 17 primary care clinicians who were randomized in a 1:1 ratio to a mailed letter about HCV screening (letter only), or a similar letter with a laboratory order for HCV screening (letter+order). Substudy B included the remaining 19 837 eligible patients followed by 417 clinicians. Active electronic patient portal users were randomized 1:5 to receive a mailed letter about HCV screening (letter), or an electronic patient portal message with similar content (patient portal); inactive patient portal users were mailed a letter. In a factorial design, patients in substudy B were also randomized 1:1 to receive standard content (usual care), or content based on principles of social norming, anticipated regret, reciprocity, and commitment (behavioral content).

Main outcome measures
Proportion of patients who completed HCV testing within four months.

Results
21 303 patients were included in the intention-to-treat analysis. Among the 1642 patients in substudy A, 19.2% (95% confidence interval 16.5% to 21.9%) completed screening in the letter only arm and 43.1% (39.7% to 46.4%) in the letter+order arm (P<0.001). Among the 19 661 patients in substudy B, 14.6% (13.9% to 15.3%) completed screening with usual care content and 13.6% (13.0% to 14.3%) with behavioral science content (P=0.06). Among active patient portal users, 17.8% (16.0% to 19.5%) completed screening after receiving a letter and 13.8% (13.1% to 14.5%) after receiving a patient portal message (P<0.001).

Conclusions
Opt out framing and effort reduction by including a signed laboratory order with outreach increased screening for HCV. Behavioral science messaging content did not increase uptake, and mailed letters achieved a greater response rate than patient portal messages.

Trial registration

ClinicalTrials.gov
NCT03712553
.
Face-to-face physiotherapy compared with a supported home exercise programme for the management of musculoskeletal conditions: protocol of a multicentre, randomised controlled trial—the REFORM trial
Authors: Withers Hannah G , Glinsky Joanne V , Chu Jackie , Jennings Matthew D , Hayes Alison J , Starkey Ian J , Palmer Blake A , Szymanek Lukas , Cruwys Jackson J , Wong David , Duong Kitty , Barnett Anne , Tindall Matthew J , Lucas Barbara R , Lambert Tara E , Sherrington Catherine , Maher Christopher G , Ferreira Manuela L , Taylor Deborah A , Harvey Lisa A 
Published: May 2021

IntroductionExercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise programme, while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively.Methods and analysisThe aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. Two hundred and ten participants will be recruited from five public hospitals in Sydney, Australia. Participants will be randomised to either the supported home exercise group or the face-to-face physiotherapy group. Participants allocated to the supported home exercise group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the face-to-face physiotherapy group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be nine secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome, and all analyses will be conducted on an intention-to-treat basis. A health economic evaluation will be conducted from a health funder plus patient perspective.Ethics and disseminationEthical approval was obtained on the 17 March 2017 from the Northern Sydney Local Health District HREC, trial number HREC/16HAWKE/431-RESP/16/287. The results of this study will be submitted for publication to peer-reviewed journals and be presented at national and international conferences. Recruitment commenced in March 2019, and it is anticipated that the trial will be completed by December 2021. This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions.Trial registration numberCPMP/ICH-135/95.Protocol versionThe most recent version of the protocol is V.1.2 dated November 2019.
Mortality attributable to fine particulate matter in Asia, 2000–2015: a cross-sectional cause-of-death analysis
Authors: Somboonsin Pattheera , Canudas-Romo Vladimir 
Published: May 2021

ObjectivesTo investigate the effect that particulate matter with a diameter of 2.5 μg (PM2.5) had on mortality in Asian populations in years 2000–2015.SettingMortality and level of PM2.5data from the United Nations, Global Burden of Disease and University of Chicago were used.Outcome measuresAge pattern of mortality and the number of life-years lost (LYL) attributable to PM2.5in years 2000–2015. LYL were further separated into causes of death to quantify the contribution of each cause.ResultsIschaemic heart disease (IHD) mortality increased to represent over 31% of the LYL attributable to PM2.5between 2005–2010 and 2010–2015 in Asia (females 31% and males 35%). However, great diversity in LYL attributable to PM2.5by causes-of-death were found across the region, with IHD proportions of LYL ranging from 25% to 63% for males from Eastern and Central Asia, respectively. Similar diversity was observed for mortality attributable to PM2.5for other causes of death across Asia: chronic obstructive pulmonary disease (LYL ranging from 6% to 28%), lung cancer (4% to 20%) and stroke (11% to 22%).ConclusionPM2.5is a crucial component in the rising health effects in Asia. The diverse trends in cause-specific mortality attributable to PM2.5creates a further challenge for health systems in the region. These findings highlight that immediate interventions are needed to mitigate the increasing levels of air pollution and with that reduce its detrimental effect on the health and mortality of Asian populations.
Comparison of trauma management between two major trauma services in Riyadh, Kingdom of Saudi Arabia and Melbourne, Australia
Authors: Alsenani Mohammad , A Alaklobi Faisal , Ford Jane , Earnest Arul , Hashem Waleed , Chowdhury Sharfuddin , Alenezi Ahmed , Fitzgerald Mark , Cameron Peter 
Published: May 2021

IntroductionThe burden of injury in the Kingdom of Saudi Arabia (KSA) has increased in recent years, but the country has lacked a consistent methodology for collecting injury data. A trauma registry has been established at a large public hospital in Riyadh from which these data are now available.ObjectivesWe aimed to provide an overview of trauma epidemiology by reviewing the first calendar year of data collection for the registry. Risk-adjusted analyses were performed to benchmark outcomes with a large Australian major trauma service in Melbourne. The findings are the first to report the trauma profile from a centre in the KSA and compare outcomes with an international level I trauma centre.MethodsThis was an observational study using records with injury dates in 2018 from the registries at both hospitals. Demographics, processes and outcomes were extracted, as were baseline characteristics. Risk-adjusted endpoints were inpatient mortality and length of stay. Binary logistic regression was used to measure the association between site and inpatient mortality.ResultsA total of 2436 and 4069 records were registered on the Riyadh and Melbourne databases, respectively. There were proportionally more men in the Saudi cohort than the Australian cohort (86% to 69%). The Saudi cohort was younger, the median age being 36 years compared with 50 years, with 51% of injuries caused by road traffic incidents. The risk-adjusted length of stay was 4.4 days less at the Melbourne hospital (95% CI 3.95 days to 4.86 days, p<0.001). The odds of in-hospital death were also less (OR 0.25; 95% CI 0.15 to 0.43, p<0.001).ConclusionsThis is the first hospital-based study of trauma in the kingdom that benchmarks with an individual international centre. There are limitations to interpreting the comparisons, however the findings have established a baseline for measuring continuous improvement in outcomes for KSA trauma services.
Tai Chi postural training for dyskinesia rehabilitation: a study protocol for a randomised controlled trial in convalescent ischaemic stroke patients
Authors: Jing Chengyang , Li Kuangshi , Li Zongheng , Sun Yiting , Wu Jiabao , Li Yingjie , Li Yuyue , Zhou Li , Zhang Zhe , Zhao Mingzhi , Zhang Yong 
Published: May 2021

IntroductionAcute ischaemic stroke (AIS) is not only seriously damaging to the physical and mental health of patients, but also has become a major social public health problem. Effective dyskinesia rehabilitation treatment in convalescence is of great significance for AIS patients’ prognosis and quality of life. Tai Chi (TC) shows great potential in improving motor function. This trial aims to evaluate the clinical efficacy of modified TC postural training (TPT), and to explore the related central-peripheral neurotransmitter mechanisms.Methods/designThe proposed study will be a multicentre randomised controlled trial. The trial will randomise 120 eligible AIS patients in a 1:1 ratio to receive TPT or Bobath rehabilitation training. Each training session will last 40 min and will be implemented once a day and five times per week (from Monday to Friday) in a duration of 4 weeks. After finishing the 4-week treatment, another 3-month follow-up period will be seen. Root mean square generated from the surface electromyogram (sEMG) will be the primary outcome. Other sEMG time-domain parameters and frequency-domain parameters and clinical scales assessment will be the secondary outcomes. Peripheral blood samples will be collected at baseline and at the end of 4-week treatment, which will be used to explore the related therapeutic mechanisms. Intention-to-treat analysis and per-protocol analysis will both be implemented in this trial.Ethics and disseminationThe study has been approved by Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, being granted approval numbers DZMEC-KY-2020–22. The research results will be disseminated through (open access) peer-reviewed publications and presentations at conferences.Trial registration numberChiCTR2000032999.
Critical care work during COVID-19: a qualitative study of staff experiences in the UK
Authors: Montgomery Catherine M , Humphreys Sally , McCulloch Corrienne , Docherty Annemarie B , Sturdy Steve , Pattison Natalie 
Published: May 2021

ObjectiveTo understand National Health Service (NHS) staff experiences of working in critical care during the first wave of the COVID-19 pandemic in the UK.DesignQualitative study using semistructured telephone interviews and rapid analysis, interpreted using Baehr’s sociological lens of ‘communities of fate’.ParticipantsForty NHS staff working in critical care, including 21 nurses, 10 doctors and advanced critical care practitioners, 4 allied health professionals, 3 operating department practitioners and 2 ward clerks. Participants were interviewed between August and October 2020; we purposefully sought the experiences of trained and experienced critical care staff and those who were redeployed.SettingFour hospitals in the UK.ResultsCOVID-19 presented staff with a situation of extreme stress, duress and social emergency, leading to a shared set of experiences which we have characterised as a community of fate. This involved not only fear and dread of working in critical care, but also a collective sense of duty and vocation. Caring for patients and families involved changes to usual ways of working, revolving around: reorganisation of space and personnel, personal protective equipment, lack of evidence for treating COVID-19, inability for families to be physically present, and the trauma of witnessing extreme patient acuity and death on a large scale. The stress and isolation of working in critical care during COVID-19 was mitigated by strong teamwork, camaraderie, pride and fulfilment.ConclusionCOVID-19 has changed working practices in critical care and profoundly affected staff physically, mentally and emotionally. Attention needs to be paid to the social and organisational conditions in which individuals work, addressing both practical resourcing and the interpersonal dynamics of critical care provision.
Positive psychological profiles based on perceived health clustering in patients with cardiovascular disease: a longitudinal study
Authors: Castillo-Mayén Rosario , Luque Bárbara , Rubio Sebastián Jesús , Cuadrado Esther , Gutiérrez-Domingo Tamara , Arenas Alicia , Delgado-Lista Javier , Pérez-Martínez Pablo , Tabernero Carmen 
Published: May 2021

ObjectivesPsychological well-being and sociodemographic factors have been associated with cardiovascular health. Positive psychological well-being research is limited in the literature; as such, this study aimed to investigate how patients with cardiovascular disease could be classified according to their perceived mental and physical health, and to identify positive psychological profiles based on this classification and test their stability over time.Design and settingLongitudinal study with patients from a public hospital located in Córdoba (Spain).ParticipantsThis study comprised 379 cardiovascular patients (87.3% men) tested at three measurement points.Outcome measuresParticipants reported their sociodemographic variables (age, sex, educational level, employment and socioeconomic status) at phase 1, while their perceived health and variables relating to positive psychological well-being were tested at this and two subsequent time points (average interval time: 9 months).ResultsThe two-step cluster analysis classified participants into three groups according to their mental and physical health levels, p<0.001: high (n=76), moderate (n=113) and low (n=189) perceived health clusters. Low perceived health was the largest cluster, comprising almost half of patients. Clusters significantly differed according to sex, p=0.002, and socioeconomic level, p=0.004. The profile analysis indicated that participants in the high perceived health cluster showed high positive affect, positivity, life satisfaction, and self-efficacy in emotion regulation, and less negative affect and use of passive strategies over the three measurement points (95% CI, all ps<0.01). Moreover, psychological profile stability for each cluster was generally found over an 18-month period, all ps<0.05.ConclusionCardiovascular patients may differ in terms of their perceived health and, accordingly, in terms of other relevant variables. Perceived health clusters generated varying and generally stable psychological profiles based on positive psychological well-being variables. Psychological interventions should be adapted to patients’ requirements.
Ginseng polysaccharides alter the gut microbiota and kynurenine/tryptophan ratio, potentiating the antitumour effect of antiprogrammed cell death 1/programmed cell death ligand 1 (anti-PD-1/PD-L1) immunotherapy
Authors: Huang Jumin , Liu Di , Wang Yuwei , Liu Liang , Li Jian , Yuan Jing , Jiang Zhihong , Jiang Zebo , Hsiao WL Wendy , Liu Haizhou , Khan Imran , Xie Ying , Wu Jianlin , Xie Yajia , Zhang Yizhong , Fu Yu , Liao Junyi , Wang Wenjun , Lai Huanling , Shi Axi , Cai Jun , Luo Lianxiang , Li Runze , Yao Xiaojun , Fan Xingxing , Wu Qibiao , Liu Zhongqiu , Yan Peiyu , Lu Jingguang , Yang Mingrong , Wang Lin , Cao Yabing , Wei Hong , Leung Elaine Lai-Han 
Published: May 2021

ObjectiveProgrammed death 1 and its ligand 1 (PD-1/PD-L1) immunotherapy is promising for late-stage lung cancer treatment, however, the response rate needs to be improved. Gut microbiota plays a crucial role in immunotherapy sensitisation and Panax ginseng has been shown to possess immunomodulatory potential. In this study, we aimed to investigate whether the combination treatment of ginseng polysaccharides (GPs) and αPD-1 monoclonal antibody (mAb) could sensitise the response by modulating gut microbiota.DesignSyngeneic mouse models were administered GPs and αPD-1 mAb, the sensitising antitumour effects of the combination therapy on gut microbiota were assessed by faecal microbiota transplantation (FMT) and 16S PacBio single-molecule real-time (SMRT) sequencing. To assess the immune-related metabolites, metabolomics analysis of the plasma samples was performed.ResultsWe found GPs increased the antitumour response to αPD-1 mAb by increasing the microbial metabolites valeric acid and decreasing L-kynurenine, as well as the ratio of Kyn/Trp, which contributed to the suppression of regulatory T cells and induction of Teff cells after combination treatment. Besides, the microbial analysis indicated that the abundance of Parabacteroides distasonis and Bacteroides vulgatus was higher in responders to anti-PD-1 blockade than non-responders in the clinic. Furthermore, the combination therapy sensitised the response to PD-1 inhibitor in the mice receiving microbes by FMT from six non-responders by reshaping the gut microbiota from non-responders towards that of responders.ConclusionOur results demonstrate that GPs combined with αPD-1 mAb may be a new strategy to sensitise non-small cell lung cancer patients to anti-PD-1 immunotherapy. The gut microbiota can be used as a novel biomarker to predict the response to anti-PD-1 immunotherapy.