Faculty Opinions recommendation of Risk factors associated with a decrease ≥2 g/dL in haemoglobin and/or ≥10% haematocrit in osteoarthritis patients taking celecoxib or a nonselective NSAID plus a PPI in a large randomised controlled trial (CONDOR).

2012 ◽  
Author(s):  
Joanne Jordan ◽  
Amanda Nelson
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Nonselective Nsaid ◽  
Factors Associated ◽  
Randomised Controlled

scholarly journals Swāsthya, an integrated chronic condition management programme for families of patients with hypertension and diabetes mellitus: a study protocol for a randomised controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M D Saju ◽  
Bindiya M Varghese ◽  
Lorane Scaria ◽  
Anuja Maria Benny ◽  
Shilpa V Yohannan ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Social Cohesion ◽  
Chronic Conditions ◽  
Chronic Condition ◽  
Controlled Trial ◽  
Risk Groups ◽  
Care Model ◽  
Randomised Controlled

Abstract Background Kerala is known as the diabetes mellitus (DM) and hypertension (HTN) capital of the world, thus compelling health professionals to model strategies, addressing their social, behavioural, and cognitive risk factors and eliminating various barriers to management. This paper describes the protocol of our study that aims to examine the effectiveness and sustainability of an integrated care model for the management of chronic conditions and their risk factors through a family-based intervention. The proposed care model targets to modify systems and processes that predispose to chronic conditions by enhancing social cohesion and social networks, preventing lifestyle risks, developing iterative cognitive interventions, and engaging the family into customised treatment adherence strategies navigated by community health social workers (CHSWs). Methods A cluster randomised controlled trial (RCT) in selected participants will be conducted involving additional assessments prior to the baseline assessment. The assessment will identify and categorise patients into four risk groups, namely behavioural, social, cognitive, and multiple, based on dominant risks identified. Eligible participants will be randomly allocated (at a ratio of 1:1) into the intervention or control arm. The intervention arm will receive social, behavioural, and cognitive or multiple interventions corresponding to the identified risk groups, whereas the control arm will receive general intervention. Both the groups will be followed up at 6 months and 12 months post baseline to measure outcomes. The primary outcome will be the control of HTN and DM, and secondary outcomes include decreased depression and anxiety and improved functioning, social cohesion, and social network linkages. The sustainability and scalability of this intervention will be assessed through cost effectiveness, acceptability, and user friendliness of the integrated approach by performing a qualitative evaluation. Discussion This RCT will inform the potential paradigm shift from a medical model of chronic condition management to a multidimensional, multisystem, and multidisciplinary convergence model navigated by CHSWs. Such a model is not currently considered in the management of chronic conditions in Kerala. Trial registration Trial has been prospectively registered on Clinical Trial Registry of India- CTRI/2020/12/029474 on 1st December 2020.

scholarly journals Shoe cushioning, body mass and running biomechanics as risk factors for running injury: a study protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e017379 ◽  
Author(s):  
Laurent Malisoux ◽  
Nicolas Delattre ◽  
Axel Urhausen ◽  
Daniel Theisen
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Injury Prevention ◽  
Body Mass ◽  
Injury Risk ◽  
Cox Regression ◽  
Controlled Trial ◽  
Study Groups ◽  
Self Report ◽  
Randomised Controlled

IntroductionRepetitive loading of the musculoskeletal system is suggested to be involved in the underlying mechanism of the majority of running-related injuries (RRIs). Accordingly, heavier runners are assumed to be at a higher risk of RRI. The cushioning system of modern running shoes is expected to protect runners again high impact forces, and therefore, RRI. However, the role of shoe cushioning in injury prevention remains unclear. The main aim of this study is to investigate the influence of shoe cushioning and body mass on RRI risk, while exploring simultaneously the association between running technique and RRI risk.Methods and analysisThis double-blinded randomised controlled trial will involve about 800 healthy leisure-time runners. They will randomly receive one of two running shoe models that will differ in their cushioning properties (ie, stiffness) by ~35%. The participants will perform a running test on an instrumented treadmill at their preferred running speed at baseline. Then they will be followed up prospectively over a 6-month period, during which they will self-report all their sports activities as well as any injury in an internet-based database TIPPS (Training and Injury Prevention Platform for Sports). Cox regression analyses will be used to compare injury risk between the study groups and to investigate the association among training, biomechanical and anatomical risk factors, and injury risk.Ethics and disseminationThe study was approved by the National Ethics Committee for Research (Ref: 201701/02 v1.1). Outcomes will be disseminated through publications in peer-reviewed journals, presentations at international conferences, as well as articles in popular magazines and on specialised websites.Trial registration numberNCT03115437, Pre-results.

scholarly journals Major GI bleeding in older persons using aspirin: incidence and risk factors in the ASPREE randomised controlled trial

Gut ◽  
2020 ◽  
pp. gutjnl-2020-321585 ◽  
Author(s):  
Suzanne E Mahady ◽  
Karen L Margolis ◽  
Andrew Chan ◽  
Galina Polekhina ◽  
Robyn L Woods ◽  
...  
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Bleeding Risk ◽  
The Elderly ◽  
Community Dwelling ◽  
Gi Bleeding ◽  
Prophylactic Use ◽  
Randomised Controlled

ObjectiveThere is a lack of robust data on significant gastrointestinal bleeding in older people using aspirin. We calculated the incidence, risk factors and absolute risk using data from a large randomised, controlled trial.DesignData were extracted from an aspirin versus placebo primary prevention trial conducted throughout 2010–2017 (‘ASPirin in Reducing Events in the Elderly (ASPREE)’, n=19 114) in community-dwelling persons aged ≥70 years. Clinical characteristics were collected at baseline and annually. The endpoint was major GI bleeding that resulted in transfusion, hospitalisation, surgery or death, adjudicated independently by two physicians blinded to trial arm.ResultsOver a median follow-up of 4.7 years (88 389 person years), there were 137 upper GI bleeds (89 in aspirin arm and 48 in placebo arm, HR 1.87, 95% CI 1.32 to 2.66, p<0.01) and 127 lower GI bleeds (73 in aspirin and 54 in placebo arm, HR 1.36, 95% CI 0.96 to 1.94, p=0.08) reflecting a 60% increase in bleeding overall. There were two fatal bleeds in the placebo arm. Multivariable analyses indicated age, smoking, hypertension, chronic kidney disease and obesity increased bleeding risk. The absolute 5-year risk of bleeding was 0.25% (95% CI 0.16% to 0.37%) for a 70 year old not on aspirin and up to 5.03% (2.56% to 8.73%) for an 80 year old taking aspirin with additional risk factors.ConclusionAspirin increases overall GI bleeding risk by 60%; however, the 5-year absolute risk of serious bleeding is modest in younger, well individuals. These data may assist patients and their clinicians to make informed decisions about prophylactic use of aspirin.Trial registration numberASPREE. NCT01038583.

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