bluuebunny/crossref_metadata_2025_split huggingface dataset:
SmartPill®as an objective parameter for determination of severity and duration of postoperative ileus: study protocol of a prospective, two-arm, open-label trial (the PIDuSA study)
Authors: Vilz Tim O , Pantelis Dimitrios , Lingohr Philipp , Fimmers Rolf , Esmann Anke , Randau Thomas , Kalff Jörg C , Coenen Martin , Wehner Sven 
Published: July 2016

IntroductionPostoperative ileus (POI) is a frequent complication after abdominal surgery (AS). Until today, neither a prophylaxis nor an evidence-based therapy exists. This originates from the absence of objective parameters evaluating the severity and duration of POI resulting in clinical trials of modest quality. The SmartPill®, a capsule which frequently measures pH value, temperature and intraluminal pressure after swallowing, offers an elegant option for analysing gastrointestinal (GI) transit times and smooth muscle activity in vivo. As the use in patients in the first months after AS is not covered by the marketing authorisation, we aim to investigate the safety and feasibility of the SmartPill®immediately after surgery. Additionally, we analyse the influence of prokinetics and laxatives as well as standardised physiotherapy on postoperative bowel contractility, as scientific evidence of its effects is still lacking.Methods and analysisThe PIDuSA study is a prospective, single-centre, two-arm, open-label trial. The SmartPill®will be applied to 55 patients undergoing AS having a high risk for POI and 10 patients undergoing extra-abdominal surgery rarely developing POI. The primary objective is the safety of the SmartPill®in patients after surgery on the basis of adverse device effects/serious adverse device effects (ADE/SADE). The sample size suggests that events with a probability of 3% could be seen with a certainty of 80% for at least once in the sample. Secondary objective is the analysis of postoperative intestinal activity in the GI tract in both groups. Furthermore, clinical signs of bowel motility disorders will be correlated to the data measured by the SmartPill®to evaluate its significance as an objective parameter for assessing POI severity. Additionally, effects of prokinetics, laxatives and physiotherapy on postoperative peristaltic activity recorded by the SmartPill®will be analysed.Ethics and disseminationThe protocol was approved by the federal authority (94.1.05-5660-8976) and the local ethics committee (092/14-MPG). Findings will be disseminated through publications and conference presentations.Trial registration numberNCT02329912; Pre-results.
Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care
Authors: Slok Annerika H M , Kotz Daniel , van Breukelen Gerard , Chavannes Niels H , Rutten-van Mölken Maureen P M H , Kerstjens Huib A M , van der Molen Thys , Asijee Guus M , Dekhuijzen P N Richard , Holverda Sebastiaan , Salomé Philippe L , Goossens Lucas M A , Twellaar Mascha , in ‘t Veen Johannes C C M , van Schayck Onno C P 
Published: July 2016

ObjectiveAssessing the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with chronic obstructive pulmonary disease (COPD) measured with the St. George's Respiratory Questionnaire (SGRQ), compared with usual care.MethodsA pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care).ResultsAt 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50).ConclusionsThis study showed that use of the ABC tool may increase quality of life and perceived quality of care.Trial registration numberNTR3788; Results.
Understanding the role of the immune system in adolescent idiopathic scoliosis: Immunometabolic CONnections to Scoliosis (ICONS) study protocol
Authors: Samaan M Constantine , Missiuna Paul , Peterson Devin , Thabane Lehana 
Published: July 2016

IntroductionAdolescent idiopathic scoliosis (AIS) affects up to 3% of children around the world. There is limited knowledge of AIS aetiopathogenesis, and this evidence is needed to develop new management strategies. Paraspinal muscle in AIS demonstrates evidence of differential fibrosis based on curve sidedness. Fibrosis is the hallmark of macrophage-driven inflammation and tissue remodelling, yet the mechanisms of fibrosis in paraspinal muscle in AIS are poorly understood.ObjectivesThe primary objective of this study is to determine the influence of curve sidedness on paraspinal muscle inflammation. Secondary objectives include defining the mechanisms of macrophage homing to muscle, and determining muscle–macrophage crosstalk in muscle fibrosis in AIS.Methods and analysisThis is a cross-sectional study conducted in a tertiary paediatric centre in Hamilton, Ontario, Canada. We will recruit boys and girls, 10–17 years of age, who are having surgery to correct AIS. We will exclude children who have an active infection or are on immunosuppressive therapies within 2 weeks of surgery, smokers and pregnant girls. Paraspinal muscle biopsies will be obtained at the start of surgery. Also, blood and urine samples will be collected from participants, who will fill questionnaires about their lifestyle. Anthropometric measures will also be collected including height, weight, waist and hip circumferences.Ethics and disseminationThis study has received ethics authorisation by the institutional review board. This work will be published in peer-reviewed journals and will be presented in oral and poster formats at scientific meetings.DiscussionThis study will explore the mechanisms of paraspinal muscle inflammation, remodelling and fibrosis in AIS. This will help identify pathways and molecules as potential therapeutic targets to treat and prevent AIS. It may also yield markers that predict scoliosis progression and response to treatment in these children.
Glycosylated haemoglobin as a predictor of cardiovascular events and mortality: a protocol for a systematic review and meta-analysis
Authors: Cavero-Redondo I , Peleteiro B , Álvarez-Bueno C , Rodríguez-Artalejo F , Martínez-Vizcaíno V 
Published: July 2016

IntroductionGlycosylated haemoglobin level (HbA1c) is an indicator of the average blood glucose concentrations over the preceding 2–3 months and is used as a convenient and well-known biomarker in clinical practice. Currently, epidemiological evidence suggests that HbA1c level is an independent risk factor for cardiovascular events such as myocardial infarction, stroke, coronary heart disease and heart failure. This protocol aim is to conduct a systematic review and meta-analysis to determine relationships of HbA1c levels with cardiovascular outcomes and cause of death, and to analyse the range of HbA1c levels that is a predictor of cardiovascular disease and/or mortality based on data from published observational studies.Methods and analysisThe search will be conducted using Medline, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Web of Science databases from their inception. Observational studies written in Portuguese, Spanish or English will be included. The Quality In Prognosis Studies tool will be used to assess the risk of bias for the studies included in the systematic review or meta-analysis. HRs for cardiovascular outcomes and causes of death with 95% CIs will be determined as primary outcomes. Subgroup analyses will be performed based on cardiovascular outcomes, cause of death studied, and type of population included in the studies.Ethics and disseminationThis systematic review will synthesise evidence on the potential of using HbA1c level as a prognostic marker for cardiovascular disease outcomes and/or mortality. The results will be disseminated by publication in a peer-reviewed journal. Ethics approval will not be needed because the data used for this systematic review will be obtained from published studies and there will be no concerns about privacy.Trial registration numberPROSPERO CRD42015032552.
Diagnosis and management of polycystic ovary syndrome in the UK (2004–2014): a retrospective cohort study
Authors: Ding Tao , Baio Gianluca , Hardiman Paul J , Petersen Irene , Sammon Cormac 
Published: July 2016

ObjectiveTo estimate the incidence and prevalence of polycystic ovary syndrome (PCOS) in UK primary care and investigate prescribing patterns before and after a PCOS diagnosis.DesignRetrospective cohort study.SettingUK primary care (2004–2014).ParticipantsWomen aged 15–45 years.Primary and secondary outcome measuresThe incidence and prevalence of diagnosed PCOS and probable PCOS (ie, those without a confirmed diagnosis but with at least 2 PCOS features recorded within 3 years). Among women with diagnosed or probable PCOS, the prevalence of prescribing of drugs typically used to treat PCOS was calculated prior to and in the 24 months after the diagnosis of PCOS.ResultsWe identified 7233 women with PCOS diagnoses and 7057 women with records suggestive of probable PCOS, corresponding to incidence rates of 0.93 and 0.91 per 1000 person-years at risk (PYAR) and an overall rate of 1.84 per 1000 PYAR. Women aged 20–24 years and women living in deprived areas had the highest incidence of PCOS. The prevalence of PCOS in 2014 was ∼2%. The proportion of women with a prescription in the 24 months after their PCOS index date varied by drug type: 10.2% metformin, 15.2% combined oral contraceptives, 18.8% acne-related treatments, 1.93% clomiphene, 1.0% spironolactone, 0.28% cyproterone and 3.11% eflornithine. Acne-related treatments were more commonly used to treat probable (28.3%) than diagnosed (12.3%) cases, while metformin was prescribed much more commonly in diagnosed cases.ConclusionsIn conclusion, compared to rates estimated in community samples, the incidence and prevalence of women presenting in primary care with PCOS diagnoses and features are low, indicating that PCOS is an under-recognised condition. Although considerable variation is observed in treatments prescribed to women with PCOS, the treatments initiated following a confirmed diagnosis generally reflect the long-term prognostic concerns raised in PCOS consensuses.
Reaction time and onset of psychological distress: the UK Health and Lifestyle Survey
Authors: Gale Catharine R , Harris Alicia , Deary Ian J 
Published: July 2016

BackgroundCross-sectional studies have shown that depression is often accompanied by less efficient cognitive function, as indicated by slower speed of information processing. The direction of effect is unclear. We investigated prospectively whether slower processing speed, as indexed by longer simple or choice reaction time, is associated with an increased risk of psychological distress.MethodsParticipants were 3088 men and women aged 18 and over who had taken part in the UK Health and Lifestyle Survey. Simple and choice reaction time was measured in the baseline survey. Symptoms of psychological distress were assessed at baseline and at the 7-year follow-up survey with the 30-item General Health Questionnaire (GHQ).ResultsIn unadjusted models, a SD slower simple or choice reaction time at baseline was associated with ORs for psychological distress (≥5 on GHQ) at follow-up of 1.14 (1.06 to 1.23; p<0.001) or 1.13 (1.04 to 1.22; p=0.002), respectively. Further adjustment for age, sex, social class, educational attainment, health behaviours, number of chronic physical illnesses present, neuroticism and GHQ score at baseline had only slight attenuating effects on these associations. In fully adjusted models, a SD slower simple or choice reaction time at baseline was associated with ORs for psychological distress of 1.11 (1.02 to 1.21; p=0.017) or 1.11 (1.00 to 1.24; p=0.048), respectively.ConclusionsSlower processing speed may be a risk factor for the development of psychological distress. Future studies should explore the extent to which slower processing speed explains previously demonstrated associations between lower intelligence and poorer mental health.
Is regular drinking in later life an indicator of good health? Evidence from the English Longitudinal Study of Ageing
Authors: Holdsworth Clare , Mendonça Marina , Pikhart Hynek , Frisher Martin , de Oliveira Cesar , Shelton Nicola 
Published: July 2016

BackgroundOlder people who drink have been shown to have better health than those who do not. This might suggest that moderate drinking is beneficial for health, or, as considered here, that older people modify their drinking as their health deteriorates. The relationship between how often older adults drink and their health is considered for two heath states: self-rated health (SRH) and depressive symptoms.MethodsData were analysed from the English Longitudinal Study of Ageing (ELSA), a prospective cohort study of older adults, using multilevel ordered logit analysis. The analysis involved 4741 participants present at wave 0, (1998/1999 and 2001), wave 4 (2008/2009) and wave 5 (2010/2011). The outcome measure was frequency of drinking in last year recorded at all three time points.ResultsOlder adults with fair/poor SRH at the onset of the study drank less frequently compared with adults with good SRH (p<0.05). Drinking frequency declined over time for all health statuses, though respondents with both continual fair/poor SRH and declining SRH experienced a sharper reduction in the frequency of their drinking over time compared with older adults who remained in good SRH or whose health improved. The findings were similar for depression, though the association between depressive symptoms and drinking frequency at the baseline was not significant after adjusting for confounding variables.ConclusionsThe frequency of older adults’ drinking responds to changes in health status and drinking frequency in later life may be an indicator, rather than a cause, of health status.
Effect of Calorie or Exercise Labels on Menus on Calories and Macronutrients Ordered and Calories from Specific Foods in Hispanic Participants: A Randomized Study
Authors: Shah Meena , Bouza Brooke , Adams-Huet Beverley , Jaffery Manall , Esposito Phil , Dart Lyn 
Published: July 2016

The effect of menu labels on food choices is unknown in Hispanics. This study evaluated the impact of menu labels on calories and macronutrients ordered in Hispanics. 372 Hispanics (18–65 years) were randomly assigned to menus with no labels (NL) (n=127), rank-ordered calorie labels plus a statement on energy needs per meal (CL) (n=123), or rank-ordered exercise labels showing minutes of brisk walking necessary to burn the food calories (EL) (n=122). The menus had identical food choices. Participants were instructed to select foods from the assigned menu as if having lunch in a fast food restaurant. One-way analysis of variance found no difference in calories ordered (median (25th and 75th centiles)) by menu condition (NL: 785.0 (465.0, 1010.0) kcal; CL: 790.0 (510.0, 1020.0) kcal; EL: 752.5 (520.0, 1033.8) kcal; p=0.75). Calories from specific foods and macronutrient intake were not different by menu condition. Menu label use was 26.8% in the CL and 25.4% in the EL condition. Calories ordered were not different between those who used and those who did not use the labels. Regression analysis showed that perception of being overweight (p=0.02), selecting foods based on health value (p<0.0001), and meeting exercise guidelines (p<0.0001) were associated with fewer calories ordered. Logistic regression showed that selecting foods based on health value (p=0.01) was associated with higher food label use. Menu labels did not affect food choices in Hispanic participants. Future studies should determine if nutrition, exercise, and weight perception counseling prior to menu labels intervention would result in better food choices. Trial registration number NCT02804503; post-results.
Long term durability and outcomes of carotid stenting and carotid endarterectomy
Authors: Jung Jin-Man , Choi Jeong-Yoon , Kim Hyun Jung , Suh Sang-il , Seo Woo-Keun 
Published: July 2016

PurposeTo evaluate the long term durability and outcomes of carotid angioplasty and stenting (CAS) compared with carotid endarterectomy (CEA).MethodsUsing multiple comprehensive databases, we searched for randomized controlled trials comparing CAS with CEA for carotid stenosis. Studies were classified according to symptom status: symptomatic, asymptomatic, or all inclusive stenosis. Postprocedural ipsilateral stroke, restenosis/occlusion after revascularization, procedural stroke/death/myocardial infarction (MI), and postprocedural ipsilateral stroke were evaluated. Subgroup analysis was performed according to follow-up duration.Results22 studies were included and classified for meta-analyses in relation to specific outcomes. The maximum follow-up duration was 10 years. The risk of postprocedural ipsilateral stroke in CEA was equivalent to that in CAS, irrespective of symptom status or follow-up time points. The CAS group had a greater risk of restenosis/occlusion after revascularization compared with CEA in studies of all inclusive stenosis. A similar tendency was found in studies of symptomatic stenosis, but without statistical significance. However, subgroup analysis showed that the risk of restenosis/occlusion in CAS decreased gradually with time, to the extent that these risks became comparable 1 year after the procedure. Procedural stroke/death/MI and postprocedural ipsilateral stroke occurred more frequently in the CAS group in studies of symptomatic stenosis although not in studies of asymptomatic or all inclusive stenosis. However, this association did not persist when studies were divided according to follow-up time points.ConclusionsAlthough CAS may be more strongly associated with periprocedural stroke/death compared with CEA, it could be a good alternative to CEA in terms of long term durability and outcomes.
Endovascular treatment of acute ischemic stroke in nonagenarians compared with younger patients in a multicenter cohort
Authors: Khan Muhib A , Baird Grayson L , Miller David , Patel Anand , Tsekhan Shawn , Yaghi Shadi , Puri Ajit , Jayaraman Mahesh , Henninger Nils , Silver Brian 
Published: July 2016

BackgroundRecent studies have demonstrated the superiority of endovascular therapy (EVT) for emergent large vessel occlusion.ObjectiveTo determine the effectiveness of EVT in nonagenarians, for whom data are limited.MethodsWe retrospectively reviewed clinical and imaging data of all patients who underwent EVT at two stroke centers between January 2012 and August 2014. The 90-day functional outcome (modified Rankin Scale (mRS) score) was compared between younger patients (age 18–89 years; n=175) and nonagenarians (n=18). The relationship between pre-stroke and 90-day post-stroke mRS was analyzed in these two groups. Multivariable analysis of age, recanalization grade, and admission National Institutes of Health Stroke Scale (NIHSS) for predicting outcome was performed.ResultsAge ≥90 years was associated with a poor (mRS >2) 90-day outcome relative to those under 90 (89% vs 52%, OR=8, 95% CI 1.7 to 35.0; p=0.0081). Nonagenarians had a higher pre-stroke mRS score (0.77; 95% CI 0.44 to 1.30) than younger patients (0.24; 95% CI 0.17 to 0.35; p=0.005). No difference was observed between nonagenarians and younger patients in the rate of mRS change from pre-stroke to 90 days (p=0.540). On multivariable regression, age (OR=1.05, 95% CI 1.03 to 1.08; p<0.0001), recanalization grade (OR=0.62 95% CI 0.42 to 0.91; p=0.015), and admission NIHSS (OR=1.07 95% CI 1.02 to 1.13; p=0.01) were associated with a poor 90-day outcome.ConclusionsNonagenarians are at a substantially higher risk of a poor 90-day outcome after EVT than younger patients. However, a small subset of nonagenarians may benefit from EVT, particularly if they have a good pre-stroke functional status. Further research is needed to identify factors associated with favorable outcome in this age cohort.
Decreasing procedure times with a standardized approach to ELVO cases
Authors: McTaggart Ryan A , Yaghi Shadi , Baird Grayson , Haas Richard A , Jayaraman Mahesh V 
Published: July 2016

BackgroundEmbolectomy is the standard of care for emergent large vessel occlusion (ELVO), and needs to be done as quickly as possible for the best possible outcomes. Optimization of workflow and process is certainly paramount. One aspect of this is process improvement to standardize as much as possible the procedure in order to decrease variability among operators, which breeds familiarity for the entire team.ObjectiveTo evaluate the impact of a standardized approach to ELVO cases in decreasing times from groin puncture to first deployment of a stent-retriever and final recanalization.MethodsA retrospective review of 83 consecutive patients consisting of a pre-standardization phase (group 1) and those after standardization (group 2). The standardization process involved all three neurointerventional radiologists agreeing on a standard approach to the cases and to the equipment to be used. Times from groin puncture to first deployment of the stent-retriever and from puncture to final reperfusion were evaluated. Angiographic outcomes were scored using the Modified Thrombolysis in Cerebral Ischemia (mTICI) score. Complications from intracranial catheter manipulation (such as wire perforation) were also recorded. Clinical outcomes were assessed based on admission and discharge National Institute of Health Stroke Scale score.ResultsThere were 22 patients in group 1 and 61 patients in group 2. Mean times from groin puncture to first deployment were 39.8 min in group 1 and 20 min in group 2, a difference which was statistically significant (p<0.0001). Overall times from puncture to final recanalization were reduced from 68.2 to 37 min, also a statistically significant difference (p<0.001). There were no cases of intraprocedural complications such as wire perforation or subarachnoid hemorrhage.ConclusionsA standardized approach to the equipment used and process for ELVO cases at a single institution can dramatically reduce procedure times.