bluuebunny/crossref_metadata_2025_split huggingface dataset:
Intensity and duration of lifestyle interventions for long-term weight loss and association with mortality: a meta-analysis of randomised trials
Authors: Singh Navneet , Stewart Ralph Alan Huston , Benatar Jocelyne Rachelle 
Published: August 2019

ObjectivesTo evaluate the importance of the frequency and duration of lifestyle interventions for achieving weight loss over ≥1 year and associations with all-cause mortality.DesignMeta-analysis of randomised trials using Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and RevMan software version 5·2 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen).Data sourcesMEDLINE, CENTRAL, Google and Science Direct databases alongside reference lists of appropriate articles and meta-analyses.Eligibility criteriaRandomised studies published in English-language journals from 1980 to June 2018 that assessed lifestyle compared with control interventions on weight loss and that included ≥100 subjects and reported weight change and mortality for ≥1 year.Data extraction and synthesisTwo independent reviewers extracted data and assessed risk of bias. Data were pooled using the generic inverse-variance method and expressed as mean differences (MDs) with 95% CI and OR with 95% CI as appropriate. Heterogeneity was assessed (Cochran Q statistic) and quantified (I2statistic). The Grading of Recommendations Assessment, Development, and Evaluation score was used to assess the certainty of the evidence.Results31 randomised trials with a total of 20 816 overweight or obese participants were included. 70% of participants had cardiometabolic risk factors. Body weight was lower for lifestyle intervention compared with the control at 1 year (3.63 kg, 95% CI 2.58 to 4.67) and at 3 years (2.45 kg, 95% CI 1.17 to 3.73). Weight loss at 1 year was greater in studies with >28 compared with ≤28 interventions per year (4.50 kg, 95% CI 3.03, 5.97 vs 2.38, 95% CI 0.78 to 3.98 kg, p=0.001). In all studies, there were 593 deaths (~0.3%/year). The ORs for mortality for weight loss interventions compared with the controls was 0.86 (95% CI 0.73 to 1.02), p=0.09.ConclusionIn predominantly healthy populations with risk factors, there is a dose response with number of lifestyle interventions and weight loss. Frequent and sustained interventions are needed to achieve a clinically significant 5% weight loss. There was insufficient evidence to reliably evaluate the benefits in persons with known cardiovascular disease or cancer.Trial registration numberCRD42018095067.
Age-specific and sex-specific reference intervals for non-fasting lipids and apolipoproteins in 7260 healthy Chinese children and adolescents measured with an Olympus AU5400 analyser: a cross-sectional study
Authors: Liu Junjie , Dai Yanpeng , Yuan Enwu , Li Yushan , Wang Quanxian , Wang Linkai , Su Yanhua 
Published: August 2019

AimsEthnic, demographic, lifestyle, genetic and environmental factors influence lipids and apolipoproteins. The aim of this study was to establish age-specific and gender-specific reference intervals for non-fasting lipids and apolipoproteins in healthy Chinese children and adolescents.MethodsThis study followed the Clinical and Laboratory Standards Institute EP28-A3c guidelines. Non-fasting samples were collected from 7260 healthy Chinese children and adolescents, and they were analysed using the Olympus AU5400 analyser for: triglycerides, total cholesterol (TC), high-density lipoprotein cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein A1 and apolipoprotein B (ApoB). The age-related and gender-related reference intervals were partitioned using the Harris-Boyd method. The non-parametric method was used to establish the lower limit (2.5th percentile) and the upper limit (97.5th percentile) for the reference intervals. The 90% CIs for the lower and upper limits were also calculated.ResultsBased on the Harris-Boyd method, gender partitions were required for TC, LDL-C and ApoB. Age differences were observed for all analytes. Paediatric reference intervals were established for non-fasting lipids and apolipoproteins based on a large population of healthy children and adolescents.ConclusionsPreviously used reference intervals did not take age and gender into account. These age-specific and gender-specific reference intervals established in this study may contribute to improved management and assessment of paediatric diseases.
Collaborative design of a decision aid for stroke survivors with multimorbidity: a qualitative study in the UK engaging key stakeholders
Authors: Porat Talya , Marshall Iain J , Sadler Euan , Vadillo Miguel A , McKevitt Christopher , Wolfe Charles D A , Curcin Vasa 
Published: August 2019

ObjectivesEffective secondary stroke prevention strategies are suboptimally used. Novel development of interventions to enable healthcare professionals and stroke survivors to manage risk factors for stroke recurrence are required. We sought to engage key stakeholders in the design and evaluation of an intervention informed by a learning health system approach, to improve risk factor management and secondary prevention for stroke survivors with multimorbidity.DesignQualitative, including focus groups, semistructured interviews and usability evaluations. Data was audio recorded, transcribed and coded thematically.ParticipantsStroke survivors, carers, health and social care professionals, commissioners, policymakers and researchers.SettingStroke survivors were recruited from the South London Stroke Register; health and social care professionals through South London general practices and King’s College London (KCL) networks; carers, commissioners, policymakers and researchers through KCL networks.Results53 stakeholders in total participated in focus groups, interviews and usability evaluations. Thirty-seven participated in focus groups and interviews, including stroke survivors and carers (n=11), health and social care professionals (n=16), commissioners and policymakers (n=6) and researchers (n=4). Sixteen participated in usability evaluations, including stroke survivors (n=8) and general practitioners (GPs; n=8). Eight themes informed the collaborative design of DOTT (Deciding On Treatments Together), a decision aid integrated with the electronic health record system, to be used in primary care during clinical consultations between the healthcare professional and stroke survivor. DOTT aims to facilitate shared decision-making on personalised treatments leading to improved treatment adherence and risk control. DOTT was found acceptable and usable among stroke survivors and GPs during a series of evaluations.ConclusionsAdopting a user-centred data-driven design approach informed an intervention that is acceptable to users and has the potential to improve patient outcomes. A future feasibility study and subsequent clinical trial will provide evidence of the effectiveness of DOTT in reducing risk of stroke recurrence.
Efficacy and safety of the combination of reduced duration prophylaxis followed by immuno-guided prophylaxis to prevent cytomegalovirus disease in lung transplant recipients (CYTOCOR STUDY): an open-label, randomised, non-inferiority clinical trial
Authors: Paez-Vega Aurora , Cantisan Sara , Vaquero José Manuel , Vidal Elisa , Luque-Pineda Antonio , Lobo-Acosta María Ángeles , Pérez Ana Belén , Alonso-Moralejo Rodrigo , Iturbe David , Monforte Victor , Otero-Gonzalez Isabel , Pastor Amparo , Ussetti Piedad , Torre-Cisneros Julian 
Published: August 2019

IntroductionProlonged use of antivirals to prevent the development of cytomegalovirus (CMV) disease in lung transplant patients has been shown to have significant side effects, for which alternatives are being sought to reduce their use. The monitoring of cell immunity against CMV could be an alternative as it has shown to be useful in identifying transplant patients at low risk of infection, who could benefit from shorter prophylaxis. Theaimof the CYTOCOR study is to demonstrate that the combination of a reduced prophylaxis strategy with subsequent CMV-specific immunological monitoring would allow CMV infection to be controlled in lung transplant patients as effectively as the usual strategy (prophylaxis followed by pre-emptive therapy), while reducing the side effects of antivirals due to the shorter duration of prophylaxis.Methods and analysisPhase III randomised, open, multicentre, parallel, non-inferiority clinical trial to study the efficacy and safety of the combination of a prophylaxis strategy up to month +3 post-transplant followed by immuno-guided prophylaxis using the QuantiFERON-CMV technique up to month +12 post-transplant to prevent CMV disease in CMV-seropositive lung transplant recipients. This strategy will be compared with a combination of a usual prophylaxis strategy up to month +6 post-transplant followed by pre-emptive therapy up to month +12. To study the incidence of CMV disease, patients will be followed up to 18 months post-transplantation. A total of 150 patients are expected to be recruited for the study.Ethics and public disseminationThe clinical trial has been approved by the Research Ethics Committees and authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS).If the hypothesis of this clinical trial is verified, the dissemination of the results could change clinical practice by increasing knowledge about the safety and efficacy of discontinuing valganciclovir prophylaxis in lung transplant recipients.Trial registration numberNCT03699254.
Hypertension management: experiences, wishes and concerns among older people—a qualitative study
Authors: van Bussel Emma , Reurich Leony , Pols Jeannette , Richard Edo , Moll van Charante Eric , Ligthart Suzanne 
Published: August 2019

ObjectivesSixty-five per cent of older people have hypertension, but little is known about their preferences and concerns regarding hypertension management. Guidelines on hypertension lack consensus on how to treat older people without previous cardiovascular disease (CVD). This asks for explicit consideration of patient preferences in decision making. Therefore, the aim of this study was to explore older peoples’ experiences, preferences, concerns and perceived involvement regarding hypertension management.DesignQualitative interview study.SettingParticipants were selected from 11 general practitioner (GP) practices in the Netherlands and purposively sampled until data saturation was achieved. Semistructured interviews were conducted, audio recorded and analysed by two researchers using thematic analysis.ParticipantsFifteen community dwelling older people aged 74–93 years with hypertension and without previous CVD participated.ResultsInterviewees rarely started the conversation about hypertension management with their GP, although they did have concerns. Reasons for not discussing the subject included low priority of hypertension concerns, reliance on GPs or trust in GPs to make the right decision on their behalf. Also, interviewees anticipated regret of reducing medication, fearing vascular incidents. Interviewees would like to discuss tailoring treatment to their needs, deprescription of medication and ways to reduce side effects. They expected GPs to be more transparent on treatment effects.ConclusionOlder people describe having little involvement in hypertension management, although they have several concerns. Since GPs are also known to be hesitant to bring up this subject, we signal a conspiracy of silence about antihypertensive medication. Through breaking this silence, GPs can facilitate shared decision-making on hypertension management and better tailored care.
Effects of adenotonsillectomy on the growth of children with obstructive sleep apnoea-hypopnea syndrome (OSAHS): protocol for a systematic review
Authors: Hua Fang , Zhao Tingting , Walsh Tanya , Sun Qiao , Chen Xiong , Worthington Helen , Jiang Fan , He Hong 
Published: August 2019

IntroductionObstructive sleep apnoea-hypopnea syndrome (OSAHS) is characterised by recurring episodes of complete or partial upper airway collapse during sleep. Persistent OSAHS is associated with long-term consequences, such as growth failure, cardiovascular and neurocognitive problems in children. Different from the aetiology of OSAHS in adults, the most common cause of paediatric OSAHS is adenotonsillar hypertrophy. Adenotonsillectomy (AT) has been recommended as the first-line treatment of paediatric OSAHS. Several studies have suggested that retarded growth caused by OSAHS can improve after AT during the prepubertal period. This review will systematically search and summarise the available evidence on the effects of AT on children’s growth.Methods and analysisWe will conduct electronic searches in MEDLINE (via PubMed), Embase, Google Scholar and the Cochrane Central Register of Controlled Trials for randomised controlled trials (RCTs) or cohort studies that included a control group. Additional records will be searched by checking the references included in the selected studies and relevant reviews. At least two authors will undertake selection of studies and data extraction independently and in duplicate. The Cochrane Risk of Bias tool and Risk Of Bias In Non-randomised Studies—of Interventions will be used to assess the risk of bias of RCT and cohort studies, respectively. A random-effects model will be used for meta-analyses. Data synthesis and other analyses will be carried out using the RevMan V.5.3 software. The Grades of Recommendation, Assessment, Development and Evaluation will be used to assess the quality of the supporting evidence behind each main comparison.Ethics and disseminationThere is no ethical issue in this systematic review given that we will only include published studies. The results will be disseminated via peer-reviewed publications and social networks.PROSPERO registration numberCRD42019125882
RESTORE—Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain: study protocol for a randomised controlled trial
Authors: Kent Peter , O'Sullivan P , Smith Anne , Haines Terry , Campbell Amity , McGregor Alison H , Hartvigsen Jan , O'Sullivan Kieran , Vickery Alistair , Caneiro JP , Schütze Robert , Laird Robert A , Attwell Stephanie , Hancock Mark 
Published: August 2019

IntroductionLow back pain (LBP) is the leading cause of disability globally and its costs exceed those of cancer and diabetes combined. Recent evidence suggests that individualised cognitive and movement rehabilitation combined with lifestyle advice (cognitive functional therapy (CFT)) may produce larger and more sustained effects than traditional approaches, and movement sensor biofeedback may enhance outcomes. Therefore, this three-arm randomised controlled trial (RCT) aims to compare the clinical effectiveness and economic efficiency of individualised CFT delivered with or without movement sensor biofeedback, with usual care for patients with chronic, disabling LBP.Methods and analysisPragmatic, three-arm, randomised, parallel group, superiority RCT comparing usual care (n=164) with CFT (n=164) and CFT-plus-movement-sensor-biofeedback (n=164). Inclusion criteria include: adults with a current episode of LBP >3 months; sought primary care ≥6 weeks ago for this episode of LBP; average LBP intensity of ≥4 (0–10 scale); at least moderate pain-related interference with work or daily activities. The CFT-only and CFT-plus-movement-sensor-biofeedback participants will receive seven treatment sessions over 12 weeks plus a ‘booster’ session at 26 weeks. All participants will be assessed at baseline, 3, 6, 13, 26, 40 and 52 weeks. The primary outcome is pain-related physical activity limitation (Roland Morris Disability Questionnaire). Linear mixed models will be used to assess the effect of treatment on physical activity limitation across all time points, with the primary comparison being a formal test of adjusted mean differences between groups at 13 weeks. For the economic (cost-utility) analysis, the primary outcome of clinical effect will be quality-adjusted life years measured across the 12-month follow-up using the EuroQol EQ-5D-5L .Ethics and disseminationApproved by Curtin University Human Research Ethics Committee (HRE2018-0062, 6 Feb 2018). Study findings will be disseminated through publication in peer-reviewed journals and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001396213).
Southampton Arm Fracture Frailty and Sarcopenia Study (SAFFSS): a study protocol for the feasibility of assessing frailty and sarcopenia among older patients with an upper limb fracture
Authors: Ibrahim Kinda , Mullee Mark , Yao Guiqing Lily , Zhu Shihua , Baxter Mark , Tilly Simon , Russell Cynthia , Roberts Helen C 
Published: August 2019

IntroductionFalls are a major health problem for older people; 35% of people aged 65+ years fall every year, leading to fractures in 10%–15%. Upper limb fractures are often the first sign of osteoporosis and routine screening for osteoporosis is recommended by the National Institute for Health and Care Excellence to prevent subsequent hip fractures. However, both frailty and sarcopenia (muscle weakness) are associated with increased risk of falling and fracture but are not routinely identified in this group. The aim of this study is to evaluate the feasibility of assessing and managing frailty and sarcopenia among people aged 65+ years with an upper limb fracture.Methods and analysisThis study will be conducted in three fracture clinics in one acute trust in England. 100 people aged 65+ years with an upper arm fracture will be recruited and assessed using six validated frailty measures and two sarcopenia tools. The prevalence of the two conditions and the best tools to use will be determined. Those with either condition will be referred to geriatric clinical teams for comprehensive geriatric assessment (CGA). We will document the proportion who are referred for CGA and those who receive CGA. Other outcome measures including falls, fractures and healthcare resource use over 6 months will be collected. In-depth interviews with a purposive sample of patients who undergo the frailty and sarcopenia assessments and healthcare professionals in fracture clinics and geriatric services will be carried out to their acceptability of assessing frailty and sarcopenia in a busy environment.Ethics and disseminationThe study was given the relevant ethical approvals from NHS Research Ethics Committee (REC No: 18/NE/0377), the University Hospital Southampton NHS Foundation Trust, and the University of Southampton, Faculty of Medicine Ethics Committee and Research Governance Office. Findings will be published in scientific journals and presented to local, national and international conferences.Trial registration numberISRCTN13848445
Subcutaneous sumatriptan for the treatment of postcraniotomy pain (SUPS trial): protocol for a randomised double-blinded placebo controlled trial
Authors: Licina Ana , Russell Jeremy , Silvers Andrew , Jin Xin , Denny Jason 
Published: August 2019

IntroductionPostcraniotomy pain protocols use opioids, which are considered suboptimal analgesia following this procedure. Multimodal analgesia components are sparse. Our null hypothesis states that sumatriptan is not different to placebo in addition to usual intravenous opioids, for the treatment of acute postcraniotomy pain.Methods and analysisThis is a prospective single-centre randomised double-blinded placebo-controlled phase III clinical trial comparing subcutaneous sumatriptan injection in the recovery area with placebo for the treatment of postcraniotomy pain. Eligible adult patients (18 years and older) undergoing craniotomy will be identified preoperatively. Both patient groups will receive a subcutaneous injection at a point where recovery-nursing staff would initiate the usual intravenous opioid analgesia as per standardised pain management protocol. In both groups, further pain management will be followed by the usual intravenous opioid administration. Primary outcome will consist of the difference in pain experienced by the two groups of patients in recovery area 60 min after the study drug administration. Postcraniotomy pain will be measured at regular intervals using the Visual Analogue Scale (VAS) in recovery area. The minimal clinically important difference of 10 mm on the VAS between the two groups will be considered as statistically significant. We will include selected clinical and patient-reported outcomes as secondary endpoints. Univariate regression will be conducted on each one of the clinically plausible potential confounders. We will enrol a total 136 patients, with the study duration of 2 years. This trial will commence recruitment on the 1 July 2019.Ethics and disseminationThis trial protocol has achieved approval by the Austin Health Research Committee, HREC/17/Austin/596. This trial was prospectively registered with Australian New Zealand Clinical Trials Registry on the 10/05/2018 with a unique trial identifier U1111-1209-9072 and registration Number ACTRN12618000793213P. Findings of this study will be disseminated in peer-reviewed academic journals.Trial registration numberU1111-1209-9072, ACTRN12618000793213P
Mental well-being, job satisfaction and self-rated workability in general practitioners and hospitalisations for ambulatory care sensitive conditions among listed patients: a cohort study combining survey data on GPs and register data on patients
Authors: Nørøxe Karen Busk , Pedersen Anette Fischer , Carlsen Anders Helles , Bro Flemming , Vedsted Peter 
Published: August 2019

BackgroundPhysicians’ work conditions and mental well-being may affect healthcare quality and efficacy. Yet the effects on objective measures of healthcare performance remain understudied. This study examined mental well-being, job satisfaction and self-rated workability in general practitioners (GPs) in relation to hospitalisations for ambulatory care sensitive conditions (ACSC-Hs), a register-based quality indicator affected by referral threshold and prevention efforts in primary care.MethodsThis is an observational study combining data from national registers and a nationwide questionnaire survey among Danish GPs. To ensure precise linkage of each patient with a specific GP, partnership practices were not included. Study cases were 461 376 adult patients listed with 392 GPs. Associations between hospitalisations in the 6-month study period and selected well-being indicators were estimated at the individual patient level and adjusted for GP gender and seniority, list size, and patient factors (comorbidity, sociodemographic characteristics).ResultsThe median number of ACSC-Hs per 1000 listed patients was 10.2 (interquartile interval: 7.0–13.7). All well-being indicators were inversely associated with ACSC-Hs, except for perceived stress (not associated). The adjusted incidence rate ratio was 1.26 (95% CI 1.13 to 1.42) for patients listed with GPs in the least favourable category of self-rated workability, and 1.19 (95% CI 1.05 to 1.35), 1.15 (95% CI 1.04 to 1.27) and 1.14 (95% CI 1.03 to 1.27) for patients listed with GPs in the least favourable categories of burn-out, job satisfaction and general well-being (the most favourable categories used as reference). Hospitalisations for conditions not classified as ambulatory care sensitive were not equally associated.ConclusionsACSC-H frequency increased with decreasing levels of GP mental well-being, job satisfaction and self-rated workability. These findings imply that GPs’ work conditions and mental well-being may have important implications for individual patients and for healthcare expenditures.