bluuebunny/crossref_metadata_2025_split huggingface dataset:
Decision support intervention (Plan Well Guide) for patients and their substitute decision-makers to improve engagement in advance care planning: protocol for a randomised trial
Authors: Howard Michelle , Slaven Marissa , Bernard Carrie , Borhan Sayem , Elston Dawn , Arora Neha , Tan Amy , Heyland Daren K 
Published: September 2019

ObjectiveThe purpose of this randomised trial is to evaluate the efficacy of a decision support intervention for serious illness decisions (the Plan Well Guide decision aid;www.PlanWellguide.com) in increasing the engagement of substitute decision-makers (SDMs) in the patient’s advance care planning process (ie, ‘ACP engagement’), specifically the SDM’s confidence and readiness for the role in the future.Methods and analysisThis study is a parallel group randomised controlled trial. We aim to enrol 90 participant dyads: patients aged 65 years and older attending outpatient healthcare settings and with indicators they would be at high risk of needing future medical decisions and their SDM. The intervention is the Plan Well Guide decision aid, administered to the patient by a facilitator, with the SDM present. The primary endpoint is change after 3 months in the SDM’s ACP engagement using a validated measure of behavioural change (SDM’s knowledge, contemplation, self-efficacy and readiness) to enact the role. The secondary endpoints are (1) ACP engagement of the patient measured by a validated survey; (2) change in SDM decisional conflict regarding involvement in future decision-making and (3) postintervention patient decisional conflict regarding preference for life-sustaining treatments. Primary and secondary continuous outcomes will be analysed using the linear regression. The mean difference and 95% CIs will be reported.Ethics and disseminationApproval was received August 2017 (2017-3714-GRA) from the Hamilton Integrated Research Ethics Board. We plan to disseminate trial results in peer-reviewed journals, at national and international conferences, and via our web-based knowledge translation platforms.Trial registration numberNCT03239639; Pre-results.
ChroniSense National Early Warning Score Study (CHESS): a wearable wrist device to measure vital signs in hospitalised patients—protocol and study design
Authors: Van Velthoven Michelle Helena , Adjei Felicia , Vavoulis Dimitris , Wells Glenn , Brindley David , Kardos Attila 
Published: September 2019

IntroductionThe National Early Warning Score is used as standard clinical practice in the UK as a track and trigger system to monitor hospitalised patients. Currently, nurses are tasked to take routine vital signs measurements and manually record these on a clinical chart. Wearable devices could provide an easier, reliable, more convenient and cost-effective method of monitoring. Our aim is to evaluate the clinical validity of Polso (ChroniSense Medical, Yokneam Illit, Israel), a wrist-based device, to provide National Early Warning Scores.Methods and analysisWe will compare Polso National Early Warning Score measurements to the currently used manual measurements in a UK Teaching District General Hospital. Patients aged 18 years or above who require recordings of observations of vital signs at least every 6 hours will be enrolled after consenting. The sample size for the study was calculated to be 300 participants based on the assumption that the final dataset will include four pairs of measurements per-patient and per-vital sign, resulting in a total of 1200 pairs of data points per vital sign. The primary outcome is the agreement on the individual parameter scores and values of the National Early Warning Score: (1) respiratory rate, (2) oxygen saturation, (3) body temperature, (4) systolic blood pressure and (5) heart rate. Secondary outcomes are the agreement on the aggregate National Early Warning Score. The incidence of adverse events will be recorded. The measurements by the device will not be used for the clinical decision-making in this study.Ethics and disseminationWe obtained ethical approval, reference number 18/LO/0123 from London—Hampstead Research Ethics Committee, through the Integrated Research Application System, (reference number: 235 034. The study received no objection from the Medicine and Health Regulatory Authority, reference number: CI/20018/005 and has National Institute for Health Research portfolio adoption status CPMS number: 32 532.Trial registration numberNCT03448861; Pre-results.
Observational retrospective study of the association of initial healthcare provider for new-onset low back pain with early and long-term opioid use
Authors: Kazis Lewis E , Ameli Omid , Rothendler James , Garrity Brigid , Cabral Howard , McDonough Christine , Carey Kathleen , Stein Michael , Sanghavi Darshak , Elton David , Fritz Julie , Saper Robert 
Published: September 2019

ObjectiveThis study examined the association of initial provider treatment with early and long-term opioid use in a national sample of patients with new-onset low back pain (LBP).DesignA retrospective cohort study of patients with new-onset LBP from 2008 to 2013.SettingThe study evaluated outpatient and inpatient claims from patient visits, pharmacy claims and inpatient and outpatient procedures with initial providers seen for new-onset LBP.Participants216 504 individuals aged 18 years or older across the USA who were diagnosed with new-onset LBP and were opioid-naïve were included. Participants had commercial or Medicare Advantage insurance.ExposuresThe primary independent variable is type of initial healthcare provider including physicians and conservative therapists (physical therapists, chiropractors, acupuncturists).Main outcome measuresShort-term opioid use (within 30 days of the index visit) following new LBP visit and long-term opioid use (starting within 60 days of the index date and either 120 or more days’ supply of opioids over 12 months, or 90 days or more supply of opioids and 10 or more opioid prescriptions over 12 months).ResultsShort-term use of opioids was 22%. Patients who received initial treatment from chiropractors or physical therapists had decreased odds of short-term and long-term opioid use compared with those who received initial treatment from primary care physicians (PCPs) (adjusted OR (AOR) (95% CI) 0.10 (0.09 to 0.10) and 0.15 (0.13 to 0.17), respectively). Compared with PCP visits, initial chiropractic and physical therapy also were associated with decreased odds of long-term opioid use in a propensity score matched sample (AOR (95% CI) 0.21 (0.16 to 0.27) and 0.29 (0.12 to 0.69), respectively).ConclusionsInitial visits to chiropractors or physical therapists is associated with substantially decreased early and long-term use of opioids. Incentivising use of conservative therapists may be a strategy to reduce risks of early and long-term opioid use.
Training patients to review scientific reports for the Patient-Centered Outcomes Research Institute: an observational study
Authors: Ivlev Ilya , Vander Ley Kelly J , Wiedrick Jack , Lesley Kira , Forester Amy , Webb Rebekah , Broitman Marina , Eden Karen B 
Published: September 2019

ObjectiveThe peer review of completed Patient-Centered Outcomes Research Institute (PCORI) funded research includes reviews from patient reviewers (patients, caregivers, and patient advocates). Very little is known about how best to support these reviewers in writing helpful comments from a patient-centred perspective. This study aimed to evaluate the effect of a new training in peer review for patient reviewers.DesignObservational study.SettingOnline.ParticipantsAdults registered in the PCORI Reviewer Database as a patient stakeholder.InterventionA new online training in peer review.Main outcome measuresChanges in reviewers’ knowledge and skills; change in self-efficacy and attitudes, satisfaction with the training and perceived benefits and relevance of the training.ResultsBefore-after training survey data were analysed for 37 (29.4% of 126) patient reviewers invited to participate in an online training as part of a quality improvement effort or as part of a PCORI peer review. The reviewers improved their answers to the knowledge questions (p<0.001, median number of answers improved 4 (95% CI 3 to 5), large effect size (ES) Cohen’sw=0.94) after the training, particularly in the questions targeting the specifics of PCORI peer review. Reviewers improved their skills in recognising helpful review comments, but those without peer-review background improved proportionally more (p=0.008, median number of answers improved 2 (95% CI 1 to 3), medium ESw=0.60). The use of training modestly increased reviewers’ confidence in completing a high-quality peer review (p=0.005, mean increase in 5-point Likert rating 0.51 (95% CI 0.17 to 0.86), small-to-medium ES Cliff’sdelta=0.32) and their excitement about providing a review slightly increased (p=0.019, mean increase in 5-point Likert rating 0.35 (95% CI 0.03 to 0.68), small ESdelta=0.19). All reviewers were satisfied with the training and would recommend it to other reviewers.ConclusionsTraining improved knowledge, skills and self-efficacy and slightly increased enthusiasm for completing a PCORI peer review.
Ethnic disparities in prevalence and patterns of smoking and nicotine dependence in rural southwest China: a cross-sectional study
Authors: Wang Xu-Ming , Wu Chao , Golden Allison Rabkin , Le Cai 
Published: September 2019

ObjectivesThis study examines ethnic disparities in prevalence and patterns of smoking and nicotine dependence in rural southwest China.DesignThis was a cross-sectional design.SettingThis study was conducted in rural Yunnan Province of China.Participants7027 consenting individuals aged ≥35 years among Han majority and four ethnic minority groups (Na Xi, Li Shu, Dai and Jing Po) participated in this study. Information about participants’ demographic characteristics as well as smoking habits and an assessment of nicotine dependence with the Fagerstrom Test for Nicotine Dependence (FTND) was obtained using a standard questionnaire.ResultsMales had significantly higher prevalence of current smoking than females (64.8% and 44.4%, p<0.01). Among current smokers, the prevalence of nicotine dependence was significantly higher in males compared with females (19.9% and 7.1%, p<0.01). Jing Po men and women had the highest prevalence of current smokers (72.2% vs 23.1%, p<0.01), whereas the highest prevalence of nicotine dependence was found in male Dai current smokers and female Li Shu current smokers (44.8% vs 32.5%, p<0.01). Filtered cigarettes were the most popular form of tobacco used across all five ethnic groups. Over 75% of tobacco users initiated smoking and regularly smoked during adolescence, and those of minority ethnicity smoked regularly at a younger age than those of Han descent (p<0.05). Individuals in all five ethnic groups with higher levels of education had a lower probability of current smoking status (p<0.05), whereas a negative association of level of education with nicotine dependence was only observed in current smokers in the Han majority and Dai ethnic minority groups. Among Han majority current smokers, higher annual household income was associated with a higher risk of nicotine dependence (p<0.05).ConclusionFuture interventions to control tobacco use should be tailored to address ethnicity and socioeconomic factors.
Resilience and quality of life (QoL) of head and neck cancer and brain tumour survivors in Pakistan: an analytical cross-sectional study protocol
Authors: Zahid Nida , Khalid Wardah , Ahmad Khabir , Bhamani Shireen Shehzad , Azam Iqbal , Asad Nargis , Jabbar Adnan Abdul , Khan Mumtaz , Enam Ather 
Published: September 2019

BackgroundCancer is a devastating disease and has detrimental effects on the quality of life (QoL) of cancer survivors and interferes with their treatment compliance. The aim of the study is to assess resilience and QoL among cancer survivors and to evaluate the important factors affecting their resilience and QoL, with respect to the Pakistani cultural context.Method and analysisA cross-sectional study will be conducted at a tertiary care hospital in Karachi, Pakistan. A minimum sample size of 250 head and neck cancers and 250 brain tumour survivors with 10% inflation for non-response rate will be required. The SD of QoL and resilience will range from 16.5 to 40.8 for head and neck cancer, and 12.7 to 34.1 for brain tumour, at 5% level of significance, with 2.5 precision. QoL will be assessed by European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-H&N35 and EORTC QLQ-BN20 and resilience will be evaluated by Wagnild and Young’s 14-item scale. Mean±SD will be reported for resilience and QoL scores. Unadjusted and adjusted β-coefficients, with 95% CI, will be reported by using multiple linear regression analysis. Correlation analysis will also be performed using Pearson or Spearman rank correlation coefficients. A p value of <0.05 will be considered significant.Ethics and disseminationEthical approval has been obtained from the Aga Khan University Pakistan’s Ethical Review Committee. Written informed consent will be taken from the participants by trained research assistants. A trained psychologist will provide on-spot counselling to the participants and those identified with severe depression will be referred to a psychiatrist. The study materials will be kept under lock and key and the electronic data base will be password protected and will only be accessed by the research team. The study findings will be disseminated through publications conferences and workshops and research briefs.Trial registration numberClinicaltrials.gov registry (NCT03466762).
Socioeconomic deprivation and regional variation in Hodgkin’s lymphoma incidence in the UK: a population-based cohort study of 10 million individuals
Authors: Rafiq Meena , Hayward Andrew , Warren-Gash Charlotte , Denaxas S , Gonzalez-Izquierdo Arturo , Lyratzopoulos Georgios , Thomas Sara 
Published: September 2019

ObjectivesHodgkin’s lymphoma (HL) is the the most common cancer in teenagers and young adults. This nationwide study conducted over a 25-year period in the UK investigates variation in HL incidence by age, sex, region and deprivation to identify trends and high-risk populations for HL development.DesignPopulation-based cohort study.SettingClinical Practice Research Datalink (CPRD) electronic primary care records linked to Hospital Episode Statistics and Index of Multiple Deprivation data were used.ParticipantsData on 10 million individuals in the UK from 1992 to 2016 were analysed.Primary and secondary outcome measuresPoisson models were used to explore differences in HL incidence by age, sex, region and deprivation. Age-specific HL incidence rates by sex and directly age-standardised incidence rates by region and deprivation group were calculated.ResultsA total of 2402 new cases of HL were identified over 78 569 436 person-years. There was significant variation in HL incidence by deprivation group. Individuals living in the most affluent areas had HL incidence 60% higher than those living in the most deprived (incidence rate ratios (IRR) 1.60, 95% CI 1.40 to 1.83), with strong evidence of a marked linear trend towards increasing HL incidence with decreasing deprivation (p=<0.001). There was significant regional variation in HL incidence across the UK, which persisted after adjusting for age, sex and deprivation (IRR 0.80–1.42, p=<0.001).ConclusionsThis study identified high-risk regions for HL development in the UK and observed a trend towards higher incidence of HL in individuals living in less deprived areas. Consistent with findings from other immune-mediated diseases, this study supports the hypothesis that an affluent childhood environment may predispose to development of immune-related neoplasms, potentially through fewer immune challenges interfering with immune maturation in early life. Understanding the mechanisms behind this immune dysfunction could inform prevention, detection and treatment of HL and other immune diseases.
Evaluating the effectiveness of the NHS Health Check programme in South England: a quasi-randomised controlled trial
Authors: Kennedy Oliver , Su Fangzhong , Pears Robert , Walmsley Emily , Roderick Paul 
Published: September 2019

ObjectiveTo evaluate uptake, risk factor detection and management from the National Health Service (NHS) Health Check (HC).DesignThis is a quasi-randomised controlled trial where participants were allocated to five cohorts based on birth year. Four cohorts were invited for an NHS HC between April 2011 and March 2015.Setting151 general practices in Hampshire, England, UK.Participants366 005 participants born 1 April 1940–31 March 1976 eligible for an NHS HC.InterventionNHS HC invitation.Main outcome measuresHC attendance and absolute percentage changes and ORs of (1) detecting cardiovascular disease (CVD) 10-year risk >10% and >20%, smokers, and total cholesterol (TC) >5.5 mmol/L and >7.5 mmol/L; (2) diagnosing hypertension, type 2 diabetes mellitus, chronic kidney disease (CKD) and atrial fibrillation (AF); and (3) new interventions with statins, antihypertensives, antiglycaemics and nicotine replacement therapy (NRT).ResultsHC attendance rose from 12% to 30% between 2011/2012 and 2014/2015 (p<0.001). HC invitation increased detection of CVD risk >10% (2.0%–3.6, p<0.001) and >20% (0.1%–0.6%, p<0.001–0.392), TC >5.5 mmol/L (4.1%–7.0%, p<0.001) and >7.5 mmol/L (0.3%–0.4% p<0.001), hypertension (0.3%–0.6%, p<0.001–0.003), and interventions with statins (0.2%–0.9%, p<0.001–0.017) and antihypertensives (0.1%–0.6%, p<0.001–0.205). There were no consistent differences in detection of smokers, NRT, or diabetes, AF or CKD. Multivariate analyses showed associations between HC invitation and detecting CVD risk >10% (OR 8.01, 95% CI 7.34 to 8.73) and >20% (5.86, 4.83 to 7.10), TC >5.5 mmol/L (3.72, 3.57 to 3.89) and >7.5 mmol/L (2.89, 2.46 to 3.38), and diagnoses of hypertension (1.33, 1.20 to 1.47) and diabetes (1.34, 1.12 to 1.61). OR of CVD risk >10% plus statin and >20% plus statin, respectively, was 2.90 (2.36 to 3.57) and 2.60 (1.92 to 3.52), and for hypertension plus antihypertensive was 1.33 (1.18 to 1.50). There were no associations with AF, CKD, antiglycaemics or NRT. Detection of several risk factors varied inversely by deprivation.ConclusionsHC invitation increased detection of cardiovascular risk factors, but corresponding increases in evidence-based interventions were modest.
Examining the effects of creatine supplementation in augmenting adaptations to resistance training in patients with prostate cancer undergoing androgen deprivation therapy: a randomised, double-blind, placebo-controlled trial
Authors: Fairman Ciaran M , Kendall Krissy L , Newton Robert U , Hart Nicolas H , Taaffe Dennis R , Chee Raphael , Tang Colin I , Galvão Daniel A 
Published: September 2019

IntroductionCreatine supplementation has consistently been demonstrated to augment adaptations in body composition, muscle strength and physical function in a variety of apparently healthy older adults and clinical populations. The effects of creatine supplementation and resistance training in individuals with cancer have yet to be investigated. This study aims to examine the effects of creatine supplementation in conjunction with resistance training on body composition, muscle strength and physical function in prostate cancer patients undergoing androgen deprivation therapy.Methods and analysisThis is a randomised, double-blind, placebo-controlled trial designed to examine the effects of creatine supplementation in addition to resistance training in patients with prostate cancer receiving androgen deprivation therapy. Both supplement and placebo groups will receive a 12-week supervised exercise programme comprising resistance training undertaken three times per week. The primary endpoint (fat-free mass) and secondary endpoints (fat mass, per cent body fat, physical fitness, quality of life and blood biomarkers) will be assessed at baseline and immediately following the intervention.Ethics and disseminationThe Human Research Ethics Committee of Edith Cowan University approved this study (ID: 22243 FAIRMAN). If the results of this trial demonstrate that creatine supplementation can augment beneficial adaptations of body composition, physical function and/or psychosocial outcomes to resistance training, this study will provide effect sizes that will inform the design of subsequent definitive randomised controlled trials. The results of this study will be published in peer-reviewed journals and presented at various national and international conferences.Trial registration numberACTRN12619000099123
Measuring changes in device use of a head-mounted low vision aid after personalised telerehabilitation: protocol for a feasibility study
Authors: Lorenzini Marie-Céline , Wittich Walter 
Published: September 2019

IntroductionA recent trend in low vision (LV) has been towards the use of portable head-mounted displays (HMDs) to enhance residual vision. The decision process around the (non-)use of such devices have been identified as multifactorial. Among important barriers identified in the context of magnifying LV aids were transportation issues and insufficient training. In recent years, telerehabilitation has become of growing interest in healthcare because it allows individuals to remain at home while receiving rehabilitation services. A recent pilot study indicated encouraging outcomes; however, very few applications of telerehabilitation for LV have been tested systematically.Methods and analysisTo help guide evidence-based practice recommendations for this modality, we will carry out a feasibility study to assess the recruitment, retention, accessibility and acceptability of an eventual fully randomised trial of telerehabilitation for people with LV using HMDs. We will recruit 60 participants aged 18+ years among prospective eSight Eyewear owners, randomised 1:1 into two parallel groups. The active intervention will be the telerehabilitation operated by a LV therapist; the control arm will be the current self-training standard provided by the device vendor. The primary feasibility outcome measures will be: time to recruit participants, loss to follow-up, accessibility and acceptability of the telerehabilitation (satisfaction of the users and LV therapist). Exploratory outcomes will be the impact of telerehabilitation on eSight Eyewear use behaviour (discontinuance rate), and validated measures of assistive-technology-related quality of life.Ethics and disseminationThe study was approved by the Ethics Review Board of theCentre de Recherche Interdisciplinaire en Réadaptation de Montréal métropolitain(CRIR# 1286–1217). Dissemination is planned via local, national and international healthcare conferences and peer-reviewed journal publications.