bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multivariable fractional polynomial interaction to investigate continuous effect modifiers in a meta-analysis on higher versus lower PEEP for patients with ARDS
Authors: Kasenda Benjamin , Sauerbrei Willi , Royston Patrick , Mercat Alain , Slutsky Arthur S , Cook Deborah , Guyatt Gordon H , Brochard Laurent , Richard Jean-Christophe M , Stewart Thomas E , Meade Maureen , Briel Matthias 
Published: September 2016

ObjectivesA recent individual patient data (IPD) meta-analysis suggested that patients with moderate or severe acute respiratory distress syndrome (ARDS) benefit from higher positive end-expiratory pressure (PEEP) ventilation strategies. However, thresholds for continuous variables (eg, hypoxaemia) are often arbitrary and linearity assumptions in regression approaches may not hold; the multivariable fractional polynomial interaction (MFPI) approach can address both problems. The objective of this study was to apply the MFPI approach to investigate interactions between four continuous patient baseline variables and higher versus lower PEEP on clinical outcomes.SettingPooled data from three randomised trials in intensive care identified by a systematic review.Participants2299 patients with acute lung injury requiring mechanical ventilation.InterventionsHigher (N=1136) versus lower PEEP (N=1163) ventilation strategy.Outcome measuresPrespecified outcomes included mortality, time to death and time-to-unassisted breathing. We examined the following continuous baseline characteristics as potential effect modifiers using MFPI: PaO2/FiO2(arterial partial oxygen pressure/ fraction of inspired oxygen), oxygenation index, respiratory system compliance (tidal volume/(inspiratory plateau pressure−PEEP)) and body mass index (BMI).ResultsWe found that for patients with PaO2/FiO2below 150 mm Hg, but above 100 mm Hg or an oxygenation index above 12 (moderate ARDS), higher PEEP reduces hospital mortality, but the beneficial effect appears to level off for patients with very severe ARDS. Patients with mild ARDS (PaO2/FiO2above 200 mm Hg or an oxygenation index below 10) do not seem to benefit from higher PEEP and might even be harmed. For patients with a respiratory system compliance above 40 mL/cm H2O or patients with a BMI above 35 kg/m2, we found a trend towards reduced mortality with higher PEEP, but there is very weak statistical confidence in these findings.ConclusionsMFPI analyses suggest a nonlinear effect modification of higher PEEP ventilation by PaO2/FiO2and oxygenation index with reduced mortality for some patients suffering from moderate ARDS.Study registration numberCRD42012003129.
Understanding negative feedback from South Asian patients: an experimental vignette study
Authors: Burt Jenni , Abel Gary , Elmore Natasha , Lloyd Cathy , Benson John , Sarson Lara , Carluccio Anna , Campbell John , Elliott Marc N , Roland Martin 
Published: September 2016

ObjectivesIn many countries, minority ethnic groups report poorer care in patient surveys. This could be because they get worse care or because they respond differently to such surveys. We conducted an experiment to determine whether South Asian people in England rate simulated GP consultations the same or differently from White British people. If these groups rate consultations similarly when viewing identical simulated consultations, it would be more likely that the lower scores reported by minority ethnic groups in real surveys reflect real differences in quality of care.DesignExperimental vignette study. Trained fieldworkers completed computer-assisted personal interviews during which participants rated 3 video recordings of simulated GP–patient consultations, using 5 communication items from the English GP Patient Survey. Consultations were shown in a random order, selected from a pool of 16.SettingGeographically confined areas of ∼130 households (output areas) in England, selected using proportional systematic sampling.Participants564 White British and 564 Pakistani adults recruited using an in-home face-to-face approach.Main outcome measureMean differences in communication score (on a scale of 0–100) between White British and Pakistani participants, estimated from linear regression.ResultsPakistani participants, on average, scored consultations 9.8 points higher than White British participants (95% CI 8.0 to 11.7, p<0.001) when viewing the same consultations. When adjusted for age, gender, deprivation, self-rated health and video, the difference increased to 11.0 points (95% CI 8.5 to 13.6, p<0.001). The largest differences were seen when participants were older (>55) and where communication was scripted to be poor.ConclusionsSubstantial differences in ratings were found between groups, with Pakistani respondents giving higher scores than White British respondents to videos showing the same care. Our findings suggest that the lower scores reported by Pakistani patients in national surveys represent genuinely worse experiences of communication compared to the White British majority.
Long-term health effects of the Eyjafjallajökull volcanic eruption: a prospective cohort study in 2010 and 2013
Authors: Hlodversdottir Heidrun , Petursdottir Gudrun , Carlsen Hanne Krage , Gislason Thorarinn , Hauksdottir Arna 
Published: September 2016

ObjectivesTo examine the long-term development of physical and mental health following exposure to a volcanic eruption.DesignPopulation-based prospective cohort study.SettingIn spring 2010, the Icelandic volcano Eyjafjallajökull erupted. Data were collected at 2 time points: in 2010 and 2013.ParticipantsAdult residents in areas close to the Eyjafjallajökull volcano (N=1096), divided according to exposure levels, and a non-exposed sample (n=475), with 80% participation rate in 2013.Main outcome measuresPhysical symptoms in the previous year (chronic) and previous month (recent), and psychological distress (General Health Questionnaire-12-item version, GHQ-12), perceived stress (Perceived Stress Scale, PSS-4) and post traumatic stress disorder (PTSD) symptoms (Primary Care PTSD, PC-PTSD).ResultsIn the exposed group, certain symptoms were higher in 2013 than in 2010, for example, morning phlegm during winter (OR 2.14; 95% CI 1.49 to 3.06), skin rash/eczema (OR 2.86; 95% CI 1.76 to 4.65), back pain (OR 1.45; 95% CI 1.03 to 2.05) and insomnia (OR 1.53; 95% CI 1.01 to 2.30), in addition to a higher prevalence of regular use of certain medications (eg, for asthma (OR 2.80; 95% CI 1.01 to 7.77)). PTSD symptoms decreased between 2010 and 2013 (OR 0.33; 95% CI 0.17 to 0.61), while the prevalence of psychological distress and perceived stress remained similar. In 2013, the exposed group showed a higher prevalence of various respiratory symptoms than did the non-exposed group, such as wheezing without a cold (high exposure OR 2.35; 95% CI 1.27 to 4.47) and phlegm (high exposure OR 2.81; 95% CI 1.48 to 5.55), some symptoms reflecting the degree of exposure (eg, nocturnal chest tightness (medium exposed OR 3.09; 95% CI 1.21 to 10.46; high exposed OR 3.42; 95% CI 1.30 to 11.79)).ConclusionsThe findings indicate that people exposed to a volcanic eruption, especially those most exposed, exhibit increased risk of certain symptoms 3–4 years after the eruption.
Efficacy and safety ofPostoperativeIntravenousParecoxib sodiumFollowed byORalCElecoxib (PIPFORCE) post-total knee arthroplasty in patients with osteoarthritis: a study protocol for a multicentre, double-blind, parallel-group trial
Authors: Zhuang Qianyu , Bian Yanyan , Wang Wei , Jiang Jingmei , Feng Bin , Sun Tiezheng , Lin Jianhao , Zhang Miaofeng , Yan Shigui , Shen Bin , Pei Fuxing , Weng Xisheng 
Published: September 2016

IntroductionTotal knee arthroplasty (TKA) has been regarded as a most painful orthopaedic surgery. Although many surgeons sequentially use parecoxib and celecoxib as a routine strategy for postoperative pain control after TKA, high quality evidence is still lacking to prove the effect of this sequential regimen, especially at the medium-term follow-up. The purpose of this study, therefore, is to evaluate efficacy and safety of postoperative intravenous parecoxib sodium followed by oral celecoxib in patients with osteoarthritis (OA) undergoing TKA. The hypothesis is that compared to placebo with opioids as rescue treatment, sequential use of parecoxib and celecoxib can achieve less morphine consumption over the postoperative 2 weeks, as well as better pain control, quicker functional recovery in the postoperative 6 weeks and less opioid-related adverse events during the 12-week recovery phase.Methods and analysisThis study is designed as a multicentre, randomised, double-blind, parallel-group and placebo-controlled trial. The target sample size is 246. All participants who meet the study inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either the parecoxib/celecoxib group or placebo group. The randomisation and allocation will be study site based. The study will consist of three phases: an initial screening phase; a 6-week double-blind treatment phase; and a 6-week follow-up phase. The primary end point is cumulative opioid consumption during 2 weeks postoperation. Secondary end points consist of the postoperative visual analogue scale score, knee joint function, quality of life, local skin temperature, erythrocyte sedimentation rate, C reactive protein, cytokines and blood coagulation parameters. Safety end points will be monitored too.Ethics and disseminationEthics approval for this study has been obtained from the Ethics Committee, Peking Union Medical College Hospital, China (Protocol number: S-572) Study results will be available as published manuscripts and presentations at national and international meetings.Trial registration numberNCT02198924.
Associations between sitting time and non-alcoholic fatty liver diseases in Chinese male workers: a cross-sectional study
Authors: Wei Huili , Qu Hua , Wang Hang , Deng Huacong 
Published: September 2016

ObjectivesVarious studies have revealed a close association between sedentary behaviour and metabolic diseases, yet the association between sedentary time and non-alcoholic fatty liver disease (NAFLD) remains unclear. In this study, we investigated the association between sitting time and NAFLD in a Chinese male population and explored its underlying mechanism.Study designA cross-sectional study.SettingChongqing, China.ParticipantsOur study included 2054 male participants; all of the participants were of Han nationality.Primary outcome measuresSitting time was assessed using a self-reported questionnaire concerning the time devoted to sitting behaviour. Various clinical and demographic biomarkers were measured. Logistic regression analyses were used to investigate the ORs and the 95% CIs between sitting time and NAFLD.ResultsWe found a higher proportion of NAFLD across the tertiles of sitting time (p trend=0.003). Multivariate linear regression analyses showed sitting time independently correlated with homoeostasis model assessment for insulin resistance (HOMA-IR), alanine aminotransferase, γ-glutamyl transpeptidase, body mass index, triglyceride and the high-sensitive C reactive protein (hsCRP) (all p<0.05). Further logistic regression analyses showed that longer sitting time (>7.1 hours/day) was associated with a higher prevalence of NAFLD (OR 1.09; 95% CI (1.04 to 1.67)) after adjusting for confounders. However, this association was insignificant after further adjusting for hsCRP (OR 1.03; 95% CI (0.92 to 1.84)).ConclusionsSitting time was positively associated with the prevalence of NAFLD, and this association might be affected by inflammation.
Cost-efficiency of specialist hyperacute in-patient rehabilitation services for medically unstable patients with complex rehabilitation needs: a prospective cohort analysis
Authors: Turner-Stokes Lynne , Bavikatte Ganesh , Williams Heather , Bill Alan , Sephton Keith 
Published: September 2016

ObjectivesTo evaluate functional outcomes, care needs and cost-efficiency of hyperacute (HA) rehabilitation for a cohort of in-patients with complex neurological disability and unstable medical/surgical conditions.DesignA multicentre cohort analysis of prospectively collected clinical data from the UK Rehabilitation Outcomes Collaborative (UKROC) national clinical database, 2012–2015.SettingTwo HA specialist rehabilitation services in England, providing different service models for HA rehabilitation.ParticipantsAll patients admitted to each of the units with an admission rehabilitation complexity M score of ≥3 (N=190; mean age 46 (SD16) years; males:females 63:37%). Diagnoses were acquired brain injury (n=166; 87%), spinal cord injury (n=9; 5%), peripheral neurological conditions (n=9; 5%) and other (n=6; 3%).InterventionSpecialist in-patient multidisciplinary rehabilitation combined with management and stabilisation of intercurrent medical and surgical problems.Outcome measuresRehabilitation complexity and medical acuity: Rehabilitation Complexity Scale—version 13. Dependency and care costs: Northwick Park Dependency Scale/Care Needs Assessment (NPDS/NPCNA). Functional independence: UK Functional Assessment Measure (UK FIM+FAM). Primary outcomes: (1) reduction in dependency and (2) cost-efficiency, measured as the time taken to offset rehabilitation costs by savings in NPCNA-estimated costs of on-going care in the community.ResultsThe mean length of stay was 103 (SD66) days. Some differences were observed between the two units, which were in keeping with the different service models. However, both units showed a significant reduction in dependency and acuity between admission and discharge on all measures (Wilcoxon: p<0.001). For the 180 (95%) patients with complete NPCNA data, the mean episode cost was £77 119 (bootstrapped 95% CI £70 614 to £83 894) and the mean reduction in ‘weekly care costs’ was £462/week (95% CI 349 to 582). The mean time to offset the cost of rehabilitation was 27.6 months (95% CI 13.2 to 43.8).ConclusionsDespite its relatively high initial cost, specialist HA rehabilitation can be highly cost-efficient, producing substantial savings in on-going care costs, and relieving pressure in the acute care services.
Prevalence and factors associated with parental concerns about development detected by theParents’ Evaluation of Developmental Status (PEDS)at 6-month, 12-month and 18-month well-child checks in a birth cohort
Authors: Woolfenden Susan , Eapen Valsamma , Jalaludin Bin , Hayen Andrew , Kemp Lynn , Dissanyake Cheryl , Hendry Alexandra , Axelsson Emma , Overs Bronwyn , Eastwood John , Črnčec Rudi , McKenzie Anne , Beasley Deborah , Murphy Elisabeth , Williams Katrina 
Published: September 2016

ObjectivesEarly identification of developmental vulnerability is vital. This study aimed to estimate the prevalence of moderate or high developmental risk on theParents' Evaluation of Developmental Status(PEDS)at 6-month, 12-month and 18-month well-child checks; identify associated risk factors; and examine documentation of thePEDSat well-child checks.Design, participantsA prospective birth cohort of 2025 children with 50% of those approached agreeing to participate. Demographic data were obtained via questionnaires and linked electronic medical records. Telephone interviews were conducted with parents to collectPEDSdata.Primary and secondary outcomesMultiple logistic regression analyses identified risk factors for moderate or high developmental risk on thePEDS. A Cumulative Risk Index examined the impact of multiple risk factors on developmental risk and documentation of thePEDSat the well-child checks.ResultsOf the original cohort, 792 (39%) had 6-month, 649 (32%) had 12-month and 565 (28%) had 18-monthPEDSdata. Parental concerns indicating moderate or high developmental risk on thePEDSwere 27% (95% CI 24 to 30) at 6 months, 27% (95% CI 24 to 30) at 12 months and 33% (95% CI 29 to 37) at 18 months. Factors associated with moderate or high developmental risk were perinatal risk (OR 12 months: 1.7 (95% CI 1.1 to 2.7)); maternal Middle Eastern or Asian nationality (OR 6 months: 1.6 (95% CI 1.1 to 2.4)), (OR 12 months: 1.7 (95% CI 1.1 to 2.7)); and household disadvantage (OR 6 months: 1.5 (95% CI 1.0 to 2.2). As the number of risk factors increased the odds increased for high or moderate developmental risk and no documentation of thePEDSat well-child checks.ConclusionsChildren with multiple risk factors are more likely to have parental concerns indicating developmental vulnerability using thePEDSand for these concerns to not be documented.
Delay to mental healthcare in a cohort of Canadian Armed Forces personnel with deployment-related mental disorders, 2002–2011: a retrospective cohort study
Authors: Boulos David , Zamorski Mark A 
Published: September 2016

ObjectiveTo assess whether the delay to care among Canadian Armed Forces (CAF) personnel who sought care for a mental disorder changed over time and in association with CAF mental health system augmentations.DesignA stratified, random sample (n=2014) was selected for study from an Afghanistan-deployed cohort (N=30 513) and the 415 (weighted N=4108) individuals diagnosed with an Afghanistan service-related mental disorder were further assessed. Diagnosis-related data were abstracted from medical records (22 June 2010 to 30 May 2011). Other data were extracted from administrative databases. Delay to care was assessed across five mental health system eras: 2002/2004, 2005/2006, 2007, 2008 and 2009/2010. Weighted Cox proportional hazards regression assessed the association between era, handled as a time-dependent covariate, and the outcome while controlling for a broad range of potential confounders (ie, sociodemographic, military and clinical characteristics). Taylor series linearisation methods and sample design weights were applied in generating descriptive and regression analysis statistics.Primary outcomeThe outcome was the delay to mental healthcare, defined as the latency from most recent Afghanistan deployment return date to diagnosis date, among individuals with an Afghanistan service-related mental disorder diagnosis.ResultsMean delay to care was 551 days (95% CI 501 to 602); the median was 400 days. Delay to care decreased in subsequent eras relative to 2002/2004; however, only the most recent era (2009/2010) was statistically significant (adjusted HR (aHR): 3.01 (95% CI 1.91 to 4.73)). Men, operations support occupations, higher ranks, non-musculoskeletal comorbidities and fewer years of military service were also independently associated with longer delays to care.ConclusionsCAF mental health system changes were associated with reduced delays to mental healthcare. Further evaluation research is needed to identify the key system changes that were most impactful.
Investigating the effects of 6 months extended duration, in-centre nocturnal versus conventional haemodialysis treatment: a non-randomised, controlled feasibility study
Authors: Churchward Darren R , Graham-Brown Matthew P M , Preston Robert , Pickering Warren , McCann Gerry P , Burton James O 
Published: September 2016

IntroductionIn-centre nocturnal haemodialysis (INHD) is an underutilised dialysis regimen that can potentially provide patients with better clinical outcomes due to extended treatment times. We have established an INHD programme within our clinical network, fulfilling a previously unmet patient need. This feasibility study aims to gather sufficient data on numerous outcome measures to inform the design of a multicentre randomised controlled trial that will establish the potential benefits of INHD and increase the availability of this service nationally and internationally.Methods and analysisThis will be a non-randomised controlled study. Prevalent patients on haemodialysis (HD) will electively change from a conventional in-centre HD regimen of 4 hours thrice weekly to a regimen of extended treatment times (5–8 hours) delivered in-centre overnight thrice weekly. After recruitment of the INHD cohort, a group of patients matched for age, gender and dialysis vintage will be selected from patients remaining on a conventional daytime dialysis programme. Outcome measures will include left ventricular mass as measured by MRI, physical performance measured by the short physical performance battery and physical activity measured by accelerometry. Additionally we will measure quality of life using validated questionnaires, nutritional status by bioimpedance spectroscopy and food diaries, and blood sampling for markers of cardiovascular disease, systemic inflammation. Suitable statistical tests shall be used to analyse the data. We will use omnibus tests to observe changes over the duration of the intervention and between groups. We will also look for associations between outcome measures that may warrant further investigation. These data will be used to inform the power calculation for future studies.Ethics and disseminationA favourable opinion was granted by Northampton Research Ethics Committee (15/EM/0268). It is anticipated that results of this study will be presented at national and international meetings, with reports being published in journals during 2017.Trial registration numberISRCTN16672784.
Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study
Authors: Mackenzie Isla S , Ford Ian , Walker Andrew , Hawkey Chris , Begg Alan , Avery Anthony , Taggar Jaspal , Wei Li , Struthers Allan D , MacDonald Thomas M 
Published: September 2016

IntroductionIschaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD.Methods and analysisThe ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014.Ethics and disseminationThe study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups.Trial registration number32017426, pre-results.