scholarly journals Effects of a 12-week cardiovascular rehabilitation programme on systemic inflammation and traditional coronary artery disease risk factors in patients with rheumatoid arthritis (CARDIA trial): a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e018540
Author(s):  
Stefan Heinze-Milne ◽  
Volodko Bakowsky ◽  
Nicholas Giacomantonio ◽  
Scott A Grandy
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factors ◽  
Heart Rate ◽  
Randomised Controlled Trial ◽  
Systemic Inflammation ◽  
Controlled Trial ◽  
Disease Assessment ◽  
Cvd Risk ◽  
Increased Risk ◽  
Randomised Controlled

IntroductionPatients with systemic inflammatory diseases such as rheumatoid arthritis (RA) have an increased risk of cardiovascular disease (CVD) above the baseline risk attributable to traditional CVD risk factors seen in the general population. Exercise in cardiac rehabilitation (CR) is designed specifically for high-risk primary prevention and those with established CVD. Even though the European League Against Rheumatism guidelines state that exercise is safe for individuals with RA and exercise can reduce CVD risk, patients with RA rarely participate in CR. Thus, little is known about CR’s impact on inflammatory and CVD risk in the RA population. The purpose of this trial is to determine the feasibility of a 12-week CR programme for patients with RA and whether it decreases CVD risk without exacerbating RA.Methods and analysisThis is a randomised controlled trial whereby 60 participants with RA will be recruited and randomly assigned to either standard of care (SOC) treatment or SOC plus a 12-week CR programme (60 min of education plus two 60 min aerobic exercise sessions/week). Exercise will be performed at 60%–80% of heart rate reserve. Outcome measures (Framingham Risk Score, resting heart rate, blood pressure, blood lipids, markers of systemic inflammation (ie, interleukin (IL) 6 and tumour necrosis factor-α (TNF-α), Clinical Disease Assessment Index, Disease Activity Score-28, physical activity levels and peak cardiorespiratory fitness) will be assessed preintervention (week-0), postintervention (week-13) and 6 months postintervention.Ethics and disseminationEthical approval was obtained from the Nova Scotia Health Authority Research Ethics Board. Results will be submitted for publication in an appropriate peer-reviewed journal.Trial registration numberNCT01534871; Pre-results

scholarly journals Evaluating the effectiveness of the NHS Health Check programme in South England: a quasi-randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029420
Author(s):  
Oliver Kennedy ◽  
Fangzhong Su ◽  
Robert Pears ◽  
Emily Walmsley ◽  
Paul Roderick
Keyword(s):  
Risk Factors ◽  
Randomised Controlled Trial ◽  
Multivariate Analyses ◽  
Controlled Trial ◽  
Health Check ◽  
Cvd Risk ◽  
General Practices ◽  
Randomised Controlled ◽  
Nhs Health Check

ObjectiveTo evaluate uptake, risk factor detection and management from the National Health Service (NHS) Health Check (HC).DesignThis 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.Setting151 general practices in Hampshire, England, UK.Participants366 005 participants born 1 April 1940–31 March 1976 eligible for an NHS HC.InterventionNHS HC invitation.Main outcome measuresHC 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).ResultsHC 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.ConclusionsHC invitation increased detection of cardiovascular risk factors, but corresponding increases in evidence-based interventions were modest.

Cardiovascular Risk in Rheumatoid Arthritis and Mechanistic Links: From Pathophysiology to Treatment

2020 ◽  
Vol 18 (5) ◽  
pp. 431-446 ◽  
Author(s):  
George E. Fragoulis ◽  
Ismini Panayotidis ◽  
Elena Nikiphorou
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factors ◽  
Current Evidence ◽  
Pharmacological Intervention ◽  
Cvd Risk ◽  
The Past ◽  
Increased Risk ◽  
Cv Disease ◽  
Obesity Hypertension ◽  
Inflammatory Burden

Rheumatoid arthritis (RA) is an autoimmune inflammatory arthritis. Inflammation, however, can spread beyond the joints to involve other organs. During the past few years, it has been well recognized that RA associates with increased risk for cardiovascular (CV) disease (CVD) compared with the general population. This seems to be due not only to the increased occurrence in RA of classical CVD risk factors and comorbidities like smoking, obesity, hypertension, diabetes, metabolic syndrome, and others but also to the inflammatory burden that RA itself carries. This is not unexpected given the strong links between inflammation and atherosclerosis and CVD. It has been shown that inflammatory cytokines which are present in abundance in RA play a significant role in every step of plaque formation and rupture. Most of the therapeutic regimes used in RA treatment seem to offer significant benefits to that end. However, more studies are needed to clarify the effect of these drugs on various parameters, including the lipid profile. Of note, although pharmacological intervention significantly helps reduce the inflammatory burden and therefore the CVD risk, control of the so-called classical risk factors is equally important. Herein, we review the current evidence for the underlying pathogenic mechanisms linking inflammation with CVD in the context of RA and reflect on the possible impact of treatments used in RA.

scholarly journals Cardiovascular Disease in Rheumatoid Arthritis: Risk Factors, Autoantibodies, and the Effect of Antirheumatic Therapies

2021 ◽  
Vol 14 ◽  
pp. 117954412110287
Author(s):  
Mir Sohail Fazeli ◽  
Vadim Khaychuk ◽  
Keith Wittstock ◽  
Boris Breznen ◽  
Grace Crocket ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Risk Factors ◽  
Cardiovascular Disease ◽  
Literature Review ◽  
Rheumatoid Factor ◽  
Qualitative Evidence Synthesis ◽  
Cvd Risk ◽  
Rheumatoid Arthritis Risk ◽  
Published Evidence ◽  
Increased Risk

Objective: To scope the current published evidence on cardiovascular risk factors in rheumatoid arthritis (RA) focusing on the role of autoantibodies and the effect of antirheumatic agents. Methods: Two reviews were conducted in parallel: A targeted literature review (TLR) describing the risk factors associated with cardiovascular disease (CVD) in RA patients; and a systematic literature review (SLR) identifying and characterizing the association between autoantibody status and CVD risk in RA. A narrative synthesis of the evidence was carried out. Results: A total of 69 publications (49 in the TLR and 20 in the SLR) were included in the qualitative evidence synthesis. The most prevalent topic related to CVD risks in RA was inflammation as a shared mechanism behind both RA morbidity and atherosclerotic processes. Published evidence indicated that most of RA patients already had significant CV pathologies at the time of diagnosis, suggesting subclinical CVD may be developing before patients become symptomatic. Four types of autoantibodies (rheumatoid factor, anti-citrullinated peptide antibodies, anti-phospholipid autoantibodies, anti-lipoprotein autoantibodies) showed increased risk of specific cardiovascular events, such as higher risk of cardiovascular death in rheumatoid factor positive patients and higher risk of thrombosis in anti-phospholipid autoantibody positive patients. Conclusion: Autoantibodies appear to increase CVD risk; however, the magnitude of the increase and the types of CVD outcomes affected are still unclear. Prospective studies with larger populations are required to further understand and quantify the association, including the causal pathway, between specific risk factors and CVD outcomes in RA patients.

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 Communicating personalised statin therapy-effects as 10-year CVD-risk or CVD-free life-expectancy: does it improve decisional conflict? Three-armed, blinded, randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e041673
Author(s):  
Nicole E M Jaspers ◽  
Frank L J Visseren ◽  
Yolanda van der Graaf ◽  
Yvo M Smulders ◽  
Olga C Damman ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Life Expectancy ◽  
Statin Therapy ◽  
Controlled Trial ◽  
Decisional Conflict ◽  
P Value ◽  
Cvd Risk ◽  
Secondary Outcomes ◽  
Randomised Controlled

ObjectiveTo determine whether communicating personalised statin therapy-effects obtained by prognostic algorithm leads to lower decisional conflict associated with statin use in patients with stable cardiovascular disease (CVD) compared with standard (non-personalised) therapy-effects.DesignHypothesis-blinded, three-armed randomised controlled trialSetting and participants303 statin users with stable CVD enrolled in a cohortInterventionParticipants were randomised in a 1:1:1 ratio to standard practice (control-group) or one of two intervention arms. Intervention arms received standard practice plus (1) a personalised health profile, (2) educational videos and (3) a structured telephone consultation. Intervention arms received personalised estimates of prognostic changes associated with both discontinuation of current statin and intensification to the most potent statin type and dose (ie, atorvastatin 80 mg). Intervention arms differed in how these changes were expressed: either change in individual 10-year absolute CVD risk (iAR-group) or CVD-free life-expectancy (iLE-group) calculated with the SMART-REACH model (http://U-Prevent.com).OutcomePrimary outcome was patient decisional conflict score (DCS) after 1 month. The score varies from 0 (no conflict) to 100 (high conflict). Secondary outcomes were collected at 1 or 6 months: DCS, quality of life, illness perception, patient activation, patient perception of statin efficacy and shared decision-making, self-reported statin adherence, understanding of statin-therapy, post-randomisation low-density lipoprotein cholesterol level and physician opinion of the intervention. Outcomes are reported as median (25th– 75th percentile).ResultsDecisional conflict differed between the intervention arms: median control 27 (20–43), iAR-group 22 (11–30; p-value vs control 0.001) and iLE-group 25 (10–31; p-value vs control 0.021). No differences in secondary outcomes were observed.ConclusionIn patients with clinically manifest CVD, providing personalised estimations of treatment-effects resulted in a small but significant decrease in decisional conflict after 1 month. The results support the use of personalised predictions for supporting decision-making.Trial registrationNTR6227/NL6080.

scholarly journals Clinical and cost effectiveness of arthritis gloves in rheumatoid arthritis (A-GLOVES): randomised controlled trial with economic analysis

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Alison Hammond ◽  
Yeliz Prior ◽  
Sarah Cotterill ◽  
Chris Sutton ◽  
Elizabeth Camacho ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Recent Change ◽  
Control Group ◽  
Dominant Hand ◽  
Night Time ◽  
Hand Pain ◽  
Randomised Controlled

Abstract Background Arthritis (or compression) gloves are widely prescribed to people with rheumatoid arthritis and other forms of hand arthritis. They are prescribed for daytime wear to reduce hand pain and improve hand function, and/or night-time wear to reduce pain, improve sleep and reduce morning stiffness. However, evidence for their effectiveness is limited. The aims of this study were to investigate the clinical and cost effectiveness of arthritis gloves compared to placebo gloves on hand pain, stiffness and function in people with rheumatoid arthritis and persistent hand pain. Methods A parallel randomised controlled trial, in adults (≥ 18 years) with rheumatoid or undifferentiated inflammatory arthritis at 16 National Health Service sites in the UK. Patients with persistent hand pain affecting function and/or sleep were eligible. Randomisation (1:1) was stratified by recent change (or not) in medication, using permuted blocks of random sizes. Three-quarter-finger length arthritis gloves (Isotoner®: applying 23-32 mmHg pressure) (intervention) were compared to loose-fitting placebo gloves (Jobskin® classic: providing no/minimal pressure) (control). Both gloves (considered to have similar thermal qualities) were provided by occupational therapists. Patients and outcome assessors were blinded; clinicians were not. The primary outcome was dominant hand pain on activity (0–10) at 12 weeks, analysed using linear regression and intention to treat principles. Results Two hundred six participants were randomly assigned (103 per arm) and 163 (84 intervention: 79 control) completed 12-week follow-up. Hand pain improved by 1.0 (intervention) and 1.2 (control), an adjusted mean difference of 0.10 (95% CI: − 0.47 to 0.67; p = 0.72). Adverse events were reported by 51% of intervention and 36% of control group participants; with 6 and 7% respectively, discontinuing glove wear. Provision of arthritis gloves cost £129, with no additional benefit. Conclusion The trial provides evidence of no clinically important effect of arthritis gloves on any of the trial outcomes (hand pain, function and stiffness) and arthritis gloves are not cost-effective. The clinical and cost-effectiveness results support ceasing provision of arthritis gloves in routine clinical practice. Funding: National Institute for Health Research. Trial registration ISRCTN, ISRCTN25892131; Registered 05/09/2016: retrospectively registered.

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