bluuebunny/crossref_metadata_2025 huggingface dataset:
Helicobacter pylorieradication treatment for gastric carcinoma prevention in asymptomatic or dyspeptic adults: systematic review and Bayesian meta-analysis of randomised controlled trials
Authors: Terasawa Teruhiko , Hamashima Chisato , Kato Katsuaki , Miyashiro Isao , Yoshikawa Takaki , Takaku Reo , Nishida Hiroshi
Published: September 2019

Objectives

Recent meta-analyses of eradication therapy inHelicobacter pylori-infected adults reported significant reductions in gastric carcinoma risk. However, concerns about supporting unfocused screening and eradication programme in healthy, asymptomatic populations have arisen. We performed a systematic review and Bayesian meta-analysis to provide an accurate interpretation of randomised evidence on the preventive effectiveness of eradication therapy on gastric carcinoma risk.

Methods

We searched databases including PubMed, Cochrane Central and Embase for reference and citation tracking without language restrictions, from inception through 31 July 2018. Paired investigators independently selected randomised controlled trials (RCTs) comparing eradication therapy with placebo or no treatment for asymptomatic or dyspepticH. pylori-infected adults with no previous gastric carcinoma. The main outcome was gastric carcinoma incidence; secondary outcomes included gastric carcinoma-specific, non-gastric carcinoma and all-cause mortality.

Results

A total of 5 population-based and 2 outpatient care-based RCTs involving 7303 adults were eligible. Eradication algorithms were heterogeneous, and unsuccessful eradication and reinfection were frequently observed. A Bayesian meta-analysis with competing risk outcomes found low-certainty evidence that eradication therapy might be more likely than control to reduce gastric carcinoma risk (HR=0.65; 95% credible interval (CrI) 0.41 to 1.0;I2=11%). The CrIs included the null effects across the subgroup and sensitivity analyses, apart from those based on particular models that excluded two RCTs that enrolled subjects with specific histological findings only (HR=0.55; CrI 0.30 to 0.89;I2=14%). The uncertainty of the average 41% risk reduction in gastric carcinoma-specific mortality included a clinically important mortality risk increase (HR=0.59 favouring eradication therapy; CrI 0.25 to 1.20;I2=13%; low certainty).

Conclusions

There is insufficient evidence to support or refute the effectiveness of eradication therapy in preventing gastric carcinoma inH. pylori-infected, high-risk populations. Rigorously conducted large RCTs of healthy infected adults only would provide evidence of the true efficacy of successful eradication.

PROSPERO registration number:CRD42014009245.
Effectiveness and safety of oral Chinese patent medicines as adjuvant treatment for unstable angina pectoris on the national essential drugs list of China: a protocol for a systematic review and network meta-analysis
Authors: Hua Zhen , Zhai Feng-Ting , Tian Jinhui , Gao Cheng-Fei , Xu Peng , Zhang Fan , Liu Si-jia , Dong Kun , Du Xiao-Feng , Zhang Zhe , Yang Guanlin
Published: September 2019

Introduction

Achieving efficacious and safe treatments for unstable angina pectoris (UAP) is still a challenging clinical problem. The availability of different oral Chinese patent medicines frequently poses a practical challenge to clinicians, namely, which one to choose as first-line regimen for treatment. This study aims to examine the comparative effectiveness and safety of oral Chinese patent medicines for UAP on the national essential drugs list of China.

Methods and analysis

We will conduct a network meta-analysis (NMA) of all randomised controlled trials to evaluate the use of oral Chinese patent medicines as adjuvant for the treatment of UAP. We will explore eight electronic databases from their inception to June 2018 and search for grey literature. Primary outcomes include mortality and the cardiovascular events. Secondary outcomes include: (1) symptom improvement; (2) ECG improvement; (3) frequency of acute angina attack; (4) duration of angina; (5) adverse effects. Two independent authors will screen titles and abstracts, review full texts, extract data, assess the risk of bias using the Cochrane risk of bias tool and assess the quality of evidence and strength of the recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE). If adequate data are available, NMA will be performed with Bayesian analysis methods.

Ethics and dissemination

The NMA will help us to reduce the uncertainty of interventions and help clinicians to make optimal and more accurate therapeutic decisions for adults with UAP. Therefore, we will publish the findings of this study in a peer-reviewed journal. No ethics approval is necessary for this study based on the nature of its design.

Trial registration number

CRD42018092822.
Taking a systems approach to explore the impacts and outcomes of a research and evaluation capacity building partnership: a protocol
Authors: Tobin Rochelle , Hallett Jonathan , Lobo Roanna , Maycock Bruce Richard
Published: September 2019

Introduction

Partnership models that bring researchers, policymakers and service providers closer together are gaining traction as a strategy to improve public health practice. Yet, there is little evidence of how these models work, or indeed if they do work. The Sexual Health and Blood-borne Virus Applied Research and Evaluation Network (SiREN) is one such model. SiREN is a partnership between researchers, policymakers and service providers that aims to develop the research and evaluation capacity and evidence-informed decision making capability of professionals working to address sexual health and bloodborne virus issues in Western Australia. This study will use a systems approach to identify the mechanisms of action, impacts and outcomes of SiREN and inform the development of evaluation tools.

Methods and analysis

Data will be collected from organisational documents, surveys, in-depth interviews and a workshop. It will be analysed using a complex adaptive systems lens and findings will be used to inform the development of a type of qualitative systems model called a causal loop diagram. The causal loop diagram will illustrate the: contextual factors influencing engagement; mechanisms of action; and impacts and outcomes of SiREN. Evaluation tools will then be developed that can be used to assess the indicators identified in the causal loop diagram.

Ethics and dissemination

Ethics approval was obtained from the Curtin University Human Research Ethics Committee (approval number: HRE2017-0090). Participants will be free to withdraw from the study at any point and confidentiality will be maintained by de-identifying participant responses in any published or shared data. The findings from this study will be shared in conference presentations, reports, peer-reviewed journals and online through websites and social media.
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

Objective

The 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 analysis

This 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 dissemination

Approval 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 number

NCT03239639; 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

Introduction

The 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 analysis

We 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 dissemination

We 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 number

NCT03448861; 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

Objective

This 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).

Design

A retrospective cohort study of patients with new-onset LBP from 2008 to 2013.

Setting

The study evaluated outpatient and inpatient claims from patient visits, pharmacy claims and inpatient and outpatient procedures with initial providers seen for new-onset LBP.

Participants

216 504 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.

Exposures

The primary independent variable is type of initial healthcare provider including physicians and conservative therapists (physical therapists, chiropractors, acupuncturists).

Main outcome measures

Short-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).

Results

Short-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).

Conclusions

Initial 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

Objective

The 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.

Design

Observational study.

Setting

Online.

Participants

Adults registered in the PCORI Reviewer Database as a patient stakeholder.

Intervention

A new online training in peer review.

Main outcome measures

Changes in reviewers’ knowledge and skills; change in self-efficacy and attitudes, satisfaction with the training and perceived benefits and relevance of the training.

Results

Before-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.

Conclusions

Training 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

Objectives

This study examines ethnic disparities in prevalence and patterns of smoking and nicotine dependence in rural southwest China.

Design

This was a cross-sectional design.

Setting

This study was conducted in rural Yunnan Province of China.

Participants

7027 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.

Results

Males 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).

Conclusion

Future 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

Background

Cancer 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 analysis

A 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 dissemination

Ethical 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 number

Clinicaltrials.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

Objectives

Hodgkin’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.

Design

Population-based cohort study.

Setting

Clinical Practice Research Datalink (CPRD) electronic primary care records linked to Hospital Episode Statistics and Index of Multiple Deprivation data were used.

Participants

Data on 10 million individuals in the UK from 1992 to 2016 were analysed.

Primary and secondary outcome measures

Poisson 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.

Results

A 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).

Conclusions

This 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

Objective

To evaluate uptake, risk factor detection and management from the National Health Service (NHS) Health Check (HC).

Design

This 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.

Setting

151 general practices in Hampshire, England, UK.

Participants

366 005 participants born 1 April 1940–31 March 1976 eligible for an NHS HC.

Intervention

NHS HC invitation.

Main outcome measures

HC 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).

Results

HC 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.

Conclusions

HC 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

Introduction

Creatine 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 analysis

This 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 dissemination

The 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 number

ACTRN12619000099123
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

Introduction

A 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 analysis

To 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 dissemination

The 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.
Population-based cross-sectional study of 11 645 Spanish nonagenarians with type 2 diabetes mellitus: cardiovascular profile, cardiovascular preventive therapies, achievement goals and sex differences
Authors: Salinero-Fort Miguel Angel , Mostaza-Prieto Jose M , Lahoz-Rallo Carlos , Vicente Díez José Ignacio , Cárdenas-Valladolid Juan
Published: September 2019

Objectives

To evaluate the risk profile, achievement of cardiometabolic goals, and frequency and optimal use of cardiovascular preventive therapies among nonagenarians with type 2 diabetes mellitus (T2DM). To investigate possible sex differences.

Design and setting

A cross-sectional population study of 11 645 persons aged ≥90 years with T2DM living in Madrid (Spain). Sociodemographic, clinical and therapy profiles were collected through electronic records in primary care. We considered antihypertensive therapy and lipid-lowering therapy to be optimal when known patients with hypertension with albuminuria received renin–angiotensin system blockers and statins had been prescribed for overt cardiovascular disease.

Results

The prevalence of coronary artery disease was higher in males than in females (21.5% vs 12.6%, p<0.01), as was that of peripheral artery disease (8.5% vs 2.3%, p<0.01). However, the prevalence of cerebrovascular disease was similar in both sexes (16.5% vs 16%; p=0.44). Haemoglobin A1c was lower than 7% in 64.4% of cases, with female predominance in patients with known dementia (67.1% female vs 59.9% male; p<0.01). Antiplatelet therapy was significantly more frequent in males than in females (48.1% vs 44.3%; p<0.01), as were statins (43.2% vs 40.2%; p<0.01). Both in primary and in secondary prevention, rates for simultaneous achievement of the HbA1c, blood pressure, LDL-C goals were significantly lower among females (p<0.01). For each criterion of optimal use of cardiovascular preventive therapies, adherence was significantly better in males than in females.

Conclusion

Our study showed that the risk of cerebrovascular disease was similar in both male and female Spanish nonagenarians. Adherence was poorer in females for all criteria of optimal use of cardiovascular preventive therapies. Our findings indicate that the known sex differences in younger patients with T2DM persist in patients aged ≥90 years. There is considerable room for improvement in standards of preventive care in nonagenarians with T2DM, especially in females.
Variations in hospital resource use across stroke care teams in England, Wales and Northern Ireland: a retrospective observational study
Authors: Lugo-Palacios David G , Gannon Brenda , Gittins Matthew , Vail Andy , Bowen Audrey , Tyson Sarah
Published: September 2019

Objective

To identify the main drivers of inpatient stroke care resource use, estimate the influence of stroke teams on the length of stay (LoS) of its patients and analyse the variation in relative performance across teams.

Design

For each of four types of stroke care teams, a two-level count data model describing the variation in LoS and identifying the team influence on LoS purged of patient and treatment characteristics was estimated. Each team effect was interpreted as a measure of stroke care relative performance and its variation was analysed.

Setting

This study used data from 145 396 admissions in 256 inpatient stroke care teams between June 2013 and July 2015 included in the national stroke register of England, Wales and Northern Ireland—Sentinel Stroke National Audit Programme.

Results

The main driver of LoS, and thus resource use, was the need for stroke therapy even after stroke severity was taken into account. Conditional on needing the therapy in question, an increase in the average amount of therapy received per inpatient day was associated with shorter LoS. Important variations in stroke care performance were found within each team category.

Conclusions

Resource use was strongly associated with stroke severity, the need for therapy and the amount of therapy received. The variations in stroke care performance were not explained by measurable patient or team characteristics. Further operational and financial analyses are needed to unmask the causes of this unexplained variation.
Assessing the global risk of cardiovascular disease among a group of university students: population-based cross-sectional study in Yaoundé, Cameroon
Authors: Nansseu Jobert Richie , Assah Felix , Petnga Saint-Just , Kameni Bibiane Siaheu , Tene Hebert Donald Fosso , Nang Francial Terrenstra , Wouna Dominic Leandry Angong , Noubiap Jean Jacques , Kamgno Joseph
Published: September 2019

Objective

To describe the global cardiovascular disease (CVD) risk distribution in a young adult-aged population living in Yaoundé, Cameroon and depict factors likely influencing this risk distribution.

Design

A cross-sectional study between May and July 2017.

Setting

The University of Yaoundé I, Cameroon.

Participants

Any university student aged 18 years and above, with no known history of CVD, found at the campus during recruitment and who voluntarily agreed to be included in the study.

Primary and secondary outcome measures

The global risk of CVD was measured with the non-laboratory-based INTERHEART Modifiable Risk Score.

Results

A total of 949 participants (54% males) were recruited; the median age was 23 (IQR 21–26) years. The CVD risk varied between 2 and 21, with a median of 9 (IQR 7–12); 51.2% of students had a low risk of CVD, 43.7% had a moderate risk and 5.1% presented a high risk of CVD. The number of years since first registration at the university (β=0.08), history of sudden death among biological parents (β=1.28), history of hypertension among brothers/sisters (β=1.33), history of HIV infection (β=4.34), the Alcohol Use Disorder Identification Test-Consumption score (β=0.13), regular exposure to firewood smoke (β=1.29), eating foods/drinks with too much sugar ≥1 time/day (β=0.96), eating foods/snacks with too much oil ≥3 times/week (β=1.20) and eating dairy products≥1 time/day (β=0.61) were the independent factors likely influencing participants’ global risk of CVD.

Conclusion

Almost 50% of participants had moderate or high risk of CVD. Specific interventions targeting major CVD risk factors should be put in place among young adults to prevent or reduce this upcoming overburdened picture of CVD.
Effects of antihypertensives, lipid-modifying drugs, glycaemic control drugs and sodium bicarbonate on the progression of stages 3 and 4 chronic kidney disease in adults: a systematic review and meta-analysis
Authors: Taylor Kathryn S , Mclellan Julie , Verbakel Jan Y , Aronson Jeffrey K , Lasserson Daniel S , Pidduck Nicola , Roberts Nia , Fleming Susannah , O'Callaghan Christopher A , Bankhead Clare R , Banerjee Amitava , Hobbs FD Richard , Perera Rafael
Published: September 2019

Objective

To evaluate the effects of drug interventions that may modify the progression of chronic kidney disease (CKD) in adults with CKD stages 3 and 4.

Design

Systematic review and meta-analysis.

Methods

Searching MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, International Clinical Trials Registry Platform, Health Technology Assessment, Science Citation Index, Social Sciences Citation Index, Conference Proceedings Citation Index and Clinical Trials Register, from March 1999 to July 2018, we identified randomised controlled trials (RCTs) of drugs for hypertension, lipid modification, glycaemic control and sodium bicarbonate, compared with placebo, no drug or a drug from another class, in ≥40 adults with CKD stages 3 and/or 4, with at least 2 years of follow-up and reporting renal function (primary outcome), proteinuria, adverse events, maintenance dialysis, transplantation, cardiovascular events, cardiovascular mortality or all-cause mortality. Two reviewers independently screened citations and extracted data. For continuous outcomes, we used the ratio of means (ROM) at the end of the trial in random-effects meta-analyses. We assessed methodological quality with the Cochrane Risk of Bias Tool and confidence in the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.

Results

We included 35 RCTs and over 51 000 patients. Data were limited, and heterogeneity varied. Final renal function (estimated glomerular filtration rate) was 6% higher in those taking glycaemic control drugs (ROM 1.06, 95% CI 1.02 to 1.10, I2=0%, low GRADE confidence) and 4% higher in those taking lipid-modifying drugs (ROM 1.04, 95% CI 1.00 to 1.08, I2=88%, very low GRADE confidence). For RCTs of antihypertensive drugs, there were no significant differences in renal function. Treatment with lipid-modifying drugs led to a 36% reduction in cardiovascular disease and 26% reduction in all-cause mortality.

Conclusions

Glycaemic control and lipid-modifying drugs may slow the progression of CKD, but we found no pooled evidence of benefit nor harm from antihypertensive drugs. However, given the data limitations, further research is needed to confirm these findings.

PROSPERO registration number

CRD42015017501.
Early invasive strategy in senior patients with non-ST-segment elevation myocardial infarction: is it cost-effective? - a decision-analytic model and value of information analysis
Authors: Simpson Julija , Javanbakht Mehdi , Vale Luke
Published: September 2019

Background

Non-ST-elevation myocardial infarction (NSTEMI) is the most common type of heart attack in the UK and it is becoming increasingly prevalent among older people. An early invasive treatment strategy may be effective and cost-effective for treating NSTEMI but evidence is currently unclear.

Objectives

To assess the cost-effectiveness of the early invasive strategy versus medical management in elderly patients with NSTEMI and to provide guidance for future research in this area.

Methods

A long-term Markov state transition model was developed. Model inputs were systematically derived from a number of sources most appropriate to a UK relevant analysis, such as published studies and national routine data. Costs were estimated from the perspective of National Health Service and Personal Social Services. The model was developed using TreeAge Pro software. Based on a probabilistic sensitivity analysis, a value of information analysis was carried out to establish the value of decision uncertainty both overall and for specific input parameters.

Results

In 2017 UK £, the incremental cost-effectiveness ratio of the early invasive strategy was £46 916 for each additional quality-adjusted life-year (QALY) gained, with a probability of being cost-effective of 23% at a cost-effectiveness threshold of £20 000/QALY. There was a considerable decision uncertainty with these results. The value of removing all this uncertainty was up to £1 920 000 annually. Most uncertainty related to clinical effectiveness parameters and the optimal study design to remove this uncertainty would be a randomised controlled trial.

Conclusion

Based on current evidence, the early invasive strategy is not likely to be cost-effective for elderly patients with NSTEMI. This conclusion should be interpreted with caution mainly due to the absence of NSTEMI-specific data and long-term clinical effectiveness estimates.
Group interventions for amyotrophic lateral sclerosis caregivers in Ireland: a randomised controlled trial protocol
Authors: Burke Tom , Wilson O'Raghallaigh Jennifer , Maguire Sinead , Galvin Miriam , Heverin Mark , Hardiman Orla , Pender Niall
Published: September 2019

Introduction

Amyotrophic lateral sclerosis (ALS) is a rapid and fatal motor disease marked by progressive physical impairment due to muscle weakness and wasting. It is multidimensional with many patients presenting with cognitive and/or behavioural impairment. Caregivers of patients with ALS, commonly non-paid immediate family members, often take primary responsibility for the complex care needs of patients in non-medicalised setting, and many as a consequence experience caregiver burden, anxiety, and/or depression.

Methods and analysis

This randomised controlled trial (RCT) will use randomisation to allocate n=75 caregivers of patients with ALS from the national ALS clinic into three groups with an equal distribution. The RCT consists of two intervention groups and a wait list control (treatment as usual [TAU]) group. The intervention arms of the trial consist of a ‘mindfulness-based stress reduction’ and ‘building better caregivers’ manualised group-based intervention, with 9 and 6 weekly sessions, respectively. The TAU group will have access to intervention at the end of the trial period. Primary outcomes are self-report questionnaires on anxiety and depression symptoms, with caregiver burden and quality of life considered secondary outcomes. Assessment will commence at baseline, immediately following the intervention period, and after a period of 12 weeks to assess the effectiveness and efficacy of participating in an intervention. Patient cognitive and behavioural data will also be considered. Means of treatment and control groups at Time 0 and 1 will be analysed using mixed model multivariate analysis of variance followed by analysis of variance, and treatment effect-sizes will be calculated. This RCT protocol is pre-results and has been registered with an international database resulting in an International Standard Randomised Controlled Trials Number (ISRCTN53226941).

Ethics and dissemination

Ethics approval was obtained from the Beaumont Hospital Medical Research Ethics Committee. Results of the main trial will be submitted for publication in a peer-reviewed journal.
Feasibility of individualised severe traumatic brain injury management using an automated assessment of optimal cerebral perfusion pressure: the COGiTATE phase II study protocol
Authors: Beqiri Erta , Smielewski Peter , Robba Chiara , Czosnyka Marek , Cabeleira Manuel Teixeira , Tas Jeanette , Donnelly Joseph , Outtrim Joanne G , Hutchinson Peter , Menon David , Meyfroidt Geert , Depreitere Bart , Aries Marcel J , Ercole Ari
Published: September 2019

Introduction

Individualising therapy is an important challenge for intensive care of patients with severe traumatic brain injury (TBI). Targeting a cerebral perfusion pressure (CPP) tailored to optimise cerebrovascular autoregulation has been suggested as an attractive strategy on the basis of a large body of retrospective observational data. The objective of this study is to prospectively assess the feasibility and safety of such a strategy compared with fixed thresholds which is the current standard of care from international consensus guidelines.

Methods and analysis

CPPOpt Guided Therapy: Assessment of Target Effectiveness (COGiTATE) is a prospective, multicentre, non-blinded randomised, controlled trial coordinated from Maastricht University Medical Center, Maastricht (The Netherlands). The other original participating centres are Cambridge University NHS Foundation Trust, Cambridge (UK), and University Hospitals Leuven, Leuven (Belgium). Adult severe TBI patients requiring intracranial pressure monitoring are randomised within the first 24 hours of admission in neurocritical care unit. For the control arm, the CPP target is the Brain Trauma Foundation guidelines target (60–70 mm Hg); for the intervention group an automated CPP target is provided as the CPP at which the patient’s cerebrovascular reactivity is best preserved (CPPopt). For a maximum of 5 days, attending clinicians review the CPP target 4-hourly. The main hypothesis of COGiTATE are: (1) in the intervention group the percentage of the monitored time with measured CPP within a range of 5 mm Hg above or below CPPopt will reach 36%; (2) the difference in between groups in daily therapy intensity level score will be lower or equal to 3.

Ethics and dissemination

Ethical approval has been obtained for each participating centre. The results will be presented at international scientific conferences and in peer-reviewed journals.

Trial registration number

NCT02982122
Healthcare resource use and costs of diabetic macular oedema for patients with antivascular endothelial growth factor versus a dexamethasone intravitreal implant in Korea: a population-based study
Authors: Cho HyunJeong , Choi Kyung Seek , Lee Joo Yong , Lee Donghwan , Choi Nam-Kyong , Lee YouKyung , Bae SeungJin
Published: September 2019

Objectives

To estimate the costs and healthcare resources of patients with diabetic macular oedema (DME) who received intravitreal antivascular endothelial growth factor (anti-VEGF) agents or a dexamethasone intravitreal implant (DEX-implant) in Korea.

Design

Retrospective cohort study.

Setting

The Korean National Health Insurance claim data from 1 January 2015 to 30 June 2017 were retrieved from the Health Insurance Review and Assessment Service.

Participants

Adult patients with DME who were diagnosed with diabetic retinopathy or DME and received ranibizumab, aflibercept or a DEX-implant in conjunction with intravitreal injection were included. Patients whose primary diagnoses were age-related macular degeneration or retinal vein occlusion were excluded.

Main outcome measures

Healthcare resource utilisation and costs related to DME in the 12-month postindex period.

Results

During the study period, 182 patients and 414 patients were identified in the anti-VEGF and DEX-implant groups, respectively, and there was no significant difference in the demographic characteristics between the two groups. The outpatient eye care-related medical costs were US$3002.33 for the anti-VEGF group vs US$2250.35 for the DEX-implant group (p<0.0001). After adjusting the relevant covariates based on the generalised linear model, the estimated outpatient eye care-related medical costs were 33% higher in the anti-VEGF group than in the DEX-implant group (p<0.0001, 95% CI 22% to 45%). The utilisation pattern of the two groups showed no significant difference except for the number of intravitreal injections, which was higher in the anti-VEGF group (2.69±2.29) than in the DEX-implant group (2.09±1.37, p<0.001).

Conclusion

The average annual eye-related medical cost of the DEX-implant group was significantly lower than that of the anti-VEGF group during the study period, which was mainly due to decreased utilisation of eye care-related injections. Further long-term studies are needed.