bluuebunny/crossref_metadata_2025_split huggingface dataset:
Assessment of a patient-reported outcome measure in men with prostate cancer who had radical surgery: a Rasch analysis
Authors: Protopapa Eva , van der Meulen Jan , Moore Caroline M , Smith Sarah C 
Published: November 2020

ObjectivesTo evaluate the psychometric properties (and identify specific anomalies to be resolved) of urinary and sexual function scales of the Symptom Tracking and Reporting (STAR) instrument for use in clinical practice with individual men using Rasch analysis.DesignProspective cohort study.Setting9 UK surgery centres in secondary care.Participants403 men diagnosed with prostate cancer and completed at least one questionnaire immediately before and at 1 or 3 months after radical prostatectomy.Primary and secondary outcomesSTAR instrument before surgery and 1 and 3 months afterwards.ResultsNeither scale fitted the Rasch model (both scales p<0.001). Both urinary (seven items) and sexual function (six items) had disordered thresholds, suggesting response categories are not working as intended. Both scales (three urinary items; five sexual function items) showed problems with item fit (large fit residuals, significant χ2, an inspection of item characteristic curves). Both scales showed items that were unstable over time (differential item functioning (DIF) by time). Both scales (four pairs of items in each scale) showed local response dependency (residual correlations >0.2 above the average). Internal consistency was acceptable at the group level for both scales. Targeting was poor for both scales, indicating an inadequate match between the location of items and the distribution of the patients, suggesting that the underlying constructs that the scales purport to measure are not clear.ConclusionUsing Rasch analysis as a diagnostic tool, we identified that both the urinary and the sexual function scales have issues that need to be resolved before STAR can be used with confidence in clinical practice. The sexual function scale, in particular, is unlikely to provide precise estimates for the outcomes experienced by men after radical prostatectomy. These results demonstrate the need to evaluate the suitability of any patient-reported outcome measure before implementation in routine clinical practice, preferably using modern psychometric methods.
Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial
Authors: Masse Marie-Hélène , Battista Marie-Claude , Wilcox Mary Elizabeth , Pinto Ruxandra , Marinoff Nicole , D'Aragon Frédérick , St-Arnaud Charles , Mayette Michael , Leclair Marc-André , Quiroz Martinez Hector , Grondin-Beaudoin Brian , Poulin Yannick , Carbonneau Élaine , Seely Andrew J E , Watpool Irene , Porteous Rebecca , Chassé Michaël , Lebrasseur Martine , Lauzier François , Turgeon Alexis F , Bellemare David , Mehta Sangeeta , Charbonney Emmanuel , Belley-Côté Émilie , Botton Édouard , Cohen Dian , Lamontagne François , Adhikari Neill K J ,   OVATION-65 team members
Published: November 2020

IntroductionVasodilatory hypotension is common among intensive care unit (ICU) patients; vasopressors are considered standard of care. However, optimal mean arterial pressure (MAP) targets for vasopressor titration are unknown. The objective of the Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65) trial is to ascertain the effect of permissive hypotension (vasopressor titration to achieve MAP 60–65 mm Hg) versus usual care on biomarkers of organ injury in hypotensive patients aged ≥65 years.Methods and analysisOVATION-65 is an allocation-concealed randomised trial in 7 Canadian hospitals. Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12 hours to maintain MAP ≥65 mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours. Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise. Patients are randomised to permissive hypotension versus usual care for up to 28 days. The primary outcome is high-sensitivity troponin T, a biomarker of cardiac injury, on day 3. Secondary outcomes include biomarkers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months). Assessors of biomarkers, mortality and cognitive function are blinded to allocation.Ethics and disseminationThis protocol has been approved at all sites. Consent is obtained from the eligible patient, the substitute decision-maker if the patient is incapable, or in a deferred fashion where permitted. End-of-grant dissemination plans include presentations, publications and social media platforms and discussion forums.Trial registration numberNCT03431181.
Effect of adjunctive glucose-lowering drugs on body weight in people with type 1 diabetes: a systematic review and network meta-analysis protocol
Authors: Laugesen Christian , Ranjan Ajenthen G. , Schmidt Signe , Rasmussen Lauge Neimann , Nørgaard Ole , Christensen Robin , Nørgaard Kirsten 
Published: November 2020

IntroductionObesity increases the risk of comorbidities and diabetes-related complications and, consequently, efforts to prevent and reduce excess weight in people with type 1 diabetes are essential. The aim of this systematic review and network meta-analysis is to assess the effect of adjunctive glucose-lowering drugs on body weight and other important health outcomes in people with type 1 diabetes.Methods and analysisThis systematic review and network meta-analysis will include randomised controlled trials (RCTs) evaluating the use of adjunctive glucose-lowering drugs for treatment of people with type 1 diabetes. MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform will be searched from inception to present. Key eligibility criteria include: RCT study design; adult participants with type 1 diabetes; treatment with a glucose-lowering drug for ≥24 weeks; and comparison of the intervention to placebo, usual care or another glucose-lowering drug. The primary outcome is change in body weight. Other major outcomes include change in HbA1c and total daily insulin dose and risk of hypoglycaemia and other adverse events. Dual study selection, data extraction and risk of bias assessment will be performed. Results from the meta-analysis will be presented as weighted mean differences for continuous outcomes and risk ratios for dichotomous outcomes. Sources of heterogeneity will be explored by subgroup and sensitivity analysis. A network meta-analysis for the primary outcome will be performed using an arm-based random-effects model based on the Bayesian framework while assessing for transitivity across studies and consistency between direct and indirect estimates. The overall quality of the evidence will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation approach for each outcome.Ethics and disseminationNo ethical assessment is required. The results of this review will be disseminated through peer-reviewed publication and conference presentation.PROSPERO registration numberCRD42020158676
Predictive role of vitamin B12 in acute kidney injury in living donor liver transplantation: a propensity score matching analysis
Authors: Park Jaesik , Choi Jung Hee , Choi Ho Joong , Hong Sang Hyun , Park Chul Soo , Choi Jong Ho , Chae Min Suk 
Published: November 2020

ObjectivesWe examine the association between vitamin B12 level and risk for acute kidney injury (AKI) in patients undergoing living donor liver transplantation (LDLT).DesignRetrospective observational cohort study.SettingUniversity hospital, from January 2009 to December 2018.ParticipantsA total of 591 patients who underwent elective LDLT were analysed in this study. Those with a preoperative history of kidney dysfunction, vitamin B12 supplementation due to alcoholism, low vitamin B12 (<200 pg/mL) or missing laboratory data were excluded.Primary and secondary outcome measuresThe population was classified into AKI and non-AKI groups according to Kidney Disease Improving Global Outcomes (KDIGO) criteria, and associations between perioperative factors and AKI were analysed. After 1:1 propensity score (PS) matching, the association between high vitamin B12 (>900 pg/mL) and postoperative AKI was evaluated.ResultsPreoperative vitamin B12 was higher in the AKI group. Potentially significant perioperative factors from univariate analyses were entered into multivariate analyses, including preoperative factors (vitamin B12, diabetes), intraoperative factors (hourly urine output) and donor graft fatty change in LDLT patients. PS matching analyses with adjustment using PS revealed that high serum vitamin B12 (>900 pg/mL) was associated with risk for AKI, and the risk was 2.8-fold higher in patients with high vitamin B12 than in those with normal vitamin B12. Higher vitamin B12 was also related to a higher AKI stage. In addition, inflammatory factors (C reactive protein, white blood cells and albumin) were associated with vitamin B12 level.ConclusionsOur study may improve the accuracy of predicting postoperative AKI by introducing preoperative vitamin B12 into risk assessments for patients undergoing LDLT.
Inequalities in the uptake of, adherence to and effectiveness of behavioural weight management interventions: systematic review protocol
Authors: Birch Jack Michael , Griffin Simon J , Kelly Michael P , Ahern Amy L 
Published: November 2020

IntroductionIt has been suggested that interventions focusing on individual behaviour change, such as behavioural weight management interventions, may exacerbate health inequalities. These intervention-generated inequalities may occur at different stages, including intervention uptake, adherence and effectiveness. We will synthesise evidence on how different measures of inequality moderate the uptake, adherence and effectiveness of behavioural weight management interventions in adults.Methods and analysisWe will update a previous systematic literature review from the United States Preventive Services Taskforce to identify trials of behavioural weight management interventions in adults aged 18 years and over that were, or could feasibly be, conducted in or recruited from primary care. Medline, Cochrane database (CENTRAL) and PsycINFO will be searched. Only randomised controlled trials (RCTs) and cluster-RCTs will be included. Two investigators will independently screen articles for eligibility and conduct risk of bias assessment. We will curate publication families for eligible trials. The PROGRESS-Plus acronym (place of residence, race/ethnicity, occupation, gender, religion, education, socioeconomic status, social capital, plus other discriminating factors) will be used to consider a comprehensive range of health inequalities. Data on trial uptake, intervention adherence, weight change and PROGRESS-Plus-related data will be extracted. Data will be synthesised narratively. We will present a Harvest plot for each PROGRESS-Plus criterion and whether each trial found a negative, positive or no health inequality gradient. We will also identify potential sources of unpublished original research data on these factors which can be synthesised through a future individual participant data meta-analysis.Ethics and disseminationEthical approval is not required as no primary data are being collected. The completed systematic review will be disseminated in a peer-reviewed journal, at conferences, and contribute to the lead author’s PhD thesis. Authors of trials included in the completed systematic review may be invited to collaborate on a future individual participant data meta-analysis.PROSPERO registration numberCRD42020173242.
Psychometric properties of the Chinese version of the TeamSTEPPS teamwork perceptions questionnaire to measure teamwork perceptions of Chinese residents: a cross-sectional study
Authors: Qu Jinglou , Zhu Yaxin , Cui Liyuan , Yang Libin , Lai Yanni , Ye Xuechen , Qu Bo 
Published: November 2020

ObjectivesThe purpose of this research was to evaluate the psychometric properties of the TeamSTEPPS Teamwork Perception Questionnaire (T-TPQ) among the Chinese residents.DesignCross-sectional study.SettingA clinical hospital of the China Medical University in Liaoning Province, China.ParticipantsA total of 664 residents were enrolled in this research. The valid response rate was 83.0% (664 of 800 residents).Main outcome measuresInternal consistency and test–retest reliability were used to assess the reliability of the questionnaire. The construct validity of the Chinese T-TPQ was evaluated by confirmatory factor analysis. Furthermore, the concurrent, convergent and discriminant validity were analysed.ResultsCronbach’s α coefficient of the T-TPQ in Chinese language was 0.923. Except for the communication dimension (0.649), the Cronbach’s α coefficient of all dimensions were satisfactory. The T-TPQ and its five dimensions reported a good test–retest reliability (0.740–0.881, p<0.01). Moreover, the results of the confirmatory factor analysis demonstrated that the construct validity of the Chinese T-TPQ was satisfactory. All dimensions significantly correlated with the Hospital Survey on Patient Safety Culture (HSOPSC) teamwork within units dimension and the Safety Attitudes Questionnaire (SAQ) teamwork climate dimension (p<0.01), and the questionnaire showed satisfactory convergent and discriminant validity.ConclusionsThe T-TPQ in Chinese language demonstrated good psychometric characteristics and was a reliable and valid questionnaire to measure the Chinese health professionals’ perception of teamwork. Thus, the Chinese version of the T-TPQ could be applied in teamwork training programmes and medical education research.
ASPIRE trial: study protocol for a double-blind randomised controlled trial of aspirin for overheating during exercise in multiple sclerosis
Authors: Kever Anne , Nelson Katherine E , Aguerre Ines M , Riley Claire S , Boehme Amelia , Lee Nancy W , Strauss Farber Rebecca , Levin Seth N , Stein Joel , Leavitt Victoria M 
Published: November 2020

IntroductionThe many benefits of exercise for persons with multiple sclerosis (MS) are well established, yet patients often refrain from exercise due to overheating and exhaustion. The present randomised controlled trial tests aspirin (acetylsalicylic acid (ASA)) as a convenient method to prevent overheating and improve exercise performance in persons with MS. The effects of ASA are compared with those of acetaminophen (APAP) and placebo.Methods and analysisParticipants are seen for a laboratory maximal exercise test on 3 separate days separated by at least 1 week. At each session, body temperature is measured before oral administration of a standard adult dose (650 mg) of ASA, APAP or placebo. One hour after drug administration, participants perform a maximal ramp test on a cycle ergometer. Primary outcomes are (a) time to exhaustion (that is, time spent cycling to peak exertion) and (b) body temperature change. Crossover analyses will include tests for effects of treatment, period, treatment–period interaction (carryover effect) and sequence.Ethics and disseminationEthical approval was granted by the institutional review board at Columbia University Irving Medical Center (reference: AAAS2529). Results of the trial will be published in peer-reviewed scientific journals and presented at national and international conferences. Neurologists, physiatrists, primary care physicians and physiotherapists are important stakeholders and will be targeted during dissemination. Positive trial results have the potential to promote aspirin therapy, an inexpensive and readily available treatment, to reduce overheating and allow more persons with MS to benefit from exercise.Trial registration numberNCT03824938.
Association of nephrolithiasis with the risk of cardiovascular diseases: a longitudinal follow-up study using a national health screening cohort
Authors: Kim So Young , Bang Woo Jin , Min Chanyang , Choi Hyo Geun 
Published: November 2020

ObjectivesThe aim of this study was to explore the associations of stroke and ischaemic heart disease in patients with nephrolithiasis.DesignA longitudinal follow-up study.SettingData from the Korean National Health Insurance Service–Health Screening Cohort (2002–2013) were retrieved to identify the occurrence of nephrolithiasis.Participants and interventionsIn total, 19 103 patients with nephrolithiasis were matched at a 1:4 ratio with control participants for age, sex, income and region of residence.Primary and secondary outcome measuresThe occurrence of stroke and ischaemic heart disease was analysed in both patients with nephrolithiasis and control participants. The primary outcome was HRs of stroke and ischaemic heart disease in a stratified Cox proportional hazards model. Smoking, alcohol consumption, obesity and Charlson Comorbidity Index were adjusted for as covariates. Subgroup analyses according to age and sex were also performed.ResultsEight per cent (1615/19 103) of patients with nephrolithiasis and 7.2% (5476/76 412) of control participants had stroke. Nine per cent (1879/19 103) of patients with nephrolithiasis and 7.7% (5895/76 412) of control participants had ischaemic heart disease. Patients with nephrolithiasis had risks of stroke and ischaemic heart disease that were 1.18 times (95% CI=1.11 to 1.24) and 1.24 times (95% CI=1.18 to 1.31) those of the control participants, respectively. The age and sex subgroups showed consistent results.ConclusionsNephrolithiasis was associated with increased risks of stroke and ischaemic heart disease.
Uptake and use of a minimum data set (MDS) for older people living and dying in care homes in England: a realist review protocol
Authors: Musa Massirfufulay Kpehe , Akdur Gizdem , Hanratty Barbara , Kelly Sarah , Gordon Adam , Peryer Guy , Spilsbury Karen , Killett Anne , Burton Jennifer , Meyer Julienne , Fortescue Sue , Towers Ann-Marie , Irvine Lisa , Goodman Claire 
Published: November 2020

IntroductionCare homes provide nursing and social care for older people who can no longer live independently at home. In the UK, there is no consistent approach to how information about residents’ medical history, care needs and preferences are collected and shared. This limits opportunities to understand the care home population, have a systematic approach to assessment and documentation of care, identifiy care home residents at risk of deterioration and review care. Countries with standardised approaches to residents’ assessment, care planning and review (eg, minimum data sets (MDS)) use the data to understand the care home population, guide resource allocation, monitor services delivery and for research. The aim of this realist review is to develop a theory-driven understanding of how care home staff implement and use MDS to plan and deliver care of individual residents.Methods and analysisA realist review will be conducted in three research stages.Stage 1 will scope the literature and develop candidate programme theories of what ensures effective uptake and sustained implementation of an MDS.Stage2 will test and refine these theories through further iterative searches of the evidence from the literature to establish how effective uptake of an MDS can be achieved.Stage 3 will consult with relevant stakeholders to test or refine the programme theory (theories) of how an MDS works at the resident level of care for different stakeholders and in what circumstances. Data synthesis will use realist logic to align data from each eligible article with possible context–mechanism–outcome configurations or specific elements that answer the research questions.Ethics and disseminationThe University of Hertfordshire Ethics Committee has approved this study (HSK/SF/UH/04169). Findings will be disseminated through briefings with stakeholders, conference presentations, a national consultation on the use of an MDS in UK long-term care settings, publications in peer-reviewed journals and in print and social media publications accessible to residents, relatives and care home staff.PROSPERO registration numberCRD42020171323; this review protocol is registered on the International Prospective Register of Systematic Reviews.
Utilisation, expenditure and cost-effectiveness of cystic fibrosis drugs in Ireland: a retrospective analysis of a national pharmacy claims database
Authors: Smith Amelia , Barry Michael 
Published: November 2020

ObjectivesTo determine the use and expenditure associated with cystic fibrosis (CF) modulator therapies in Ireland since their reimbursement in 2013.DesignA retrospective analysis of a national drug claims database.SettingThe data included in this study are nationally representative (Ireland).ParticipantsData on all persons receiving CF modulator therapies were included.MethodsWe obtained national claims data for CF therapies from the Health Service Executive’s Primary Care Reimbursement Service. We determined the use and expenditure associated with CF therapies from January 2012 to March 2020.ResultsThe increased prescribing of CF modulator therapies was associated with an approximate fivefold increase in expenditure from €23 million in 2013 to €113 million in 2019. Many patients who initiated lumacaftor/ivacaftor in 2017 went on to receive symptomatic therapies, and subsequently initiated tezacaftor/ivacaftor in 2019.ConclusionDespite none of these modulator therapies demonstrating value for money when subjected to health technology assessment, the associated Irish expenditure reached €113 million in 2019 alone.
Are the needs of people with multiple long-term conditions being met? Evidence from the 2018 General Practice Patient Survey
Authors: Rolewicz Lucina , Keeble Eilís , Paddison Charlotte , Scobie Sarah 
Published: November 2020

ObjectivesTo investigate individual, practice and area level variation in patient-reported unmet need among those with long-term conditions, in the context of general practice (GP) appointments and support from community-based services in England.DesignCross-sectional study using data from 199 150 survey responses.SettingPrimary care and community-based services.ParticipantsRespondents to the 2018 English General Practice Patient Survey with at least one long-term condition.Primary and secondary outcome measuresThe primary outcomes were the levels of unmet need in GP and local services among patients with multiple long-term conditions. Secondary outcomes were the proportion of variation explained by practice and area-level factors.ResultsThere was no relationship between needs being fully met in patients’ last practice appointment and number of long-term conditions once sociodemographic characteristics and health status were taken into account (5+conditions−OR=1.04, 95% CI 0.99 to 1.09), but there was a relationship for having enough support from local services to manage conditions (5+conditions−OR=0.84, 95% CI 0.80 to 0.88). Patients with multimorbidity that were younger, non-white or frail were less likely to have their needs fully met, both in GP and from local services. Differences between practices and local authorities explained minimal variation in unmet need.ConclusionsLevels of unmet need are high, particularly for support from community services to manage multiple conditions. Patients who could be targeted for support include people who feel socially isolated, and those who have difficulties with their day-to-day living. Younger patients and certain ethnic groups with multimorbidity are also more likely to have unmet needs. Increased personalisation and coordination of care among these groups may help in addressing their needs.