scholarly journals Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

2014 ◽  
Vol 74 (6) ◽  
pp. 963-969 ◽  
Author(s):  
Maya H Buch ◽  
Lucia Silva-Fernandez ◽  
Loreto Carmona ◽  
Daniel Aletaha ◽  
Robin Christensen ◽  
...  
Keyword(s):  
Ethical Issues ◽  
Task Force ◽  
Controlled Trial ◽  
Drop Out ◽  
Eular Recommendations ◽  
European League Against Rheumatism ◽  
Patient Representatives ◽  
Minimal Data ◽  
Definition Of ◽  
Randomised Controlled

ObjectivesOur initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports.MethodsWe formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance.ResultsSeven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations.ConclusionsThis EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes.

scholarly journals EULAR recommendations for the management of Sjögren’s syndrome with topical and systemic therapies

2019 ◽  
Vol 79 (1) ◽  
pp. 3-18 ◽  
Author(s):  
Manuel Ramos-Casals ◽  
Pilar Brito-Zerón ◽  
Stefano Bombardieri ◽  
Hendrika Bootsma ◽  
Salvatore De Vita ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Task Force ◽  
Systemic Disease ◽  
Immunosuppressive Agents ◽  
Collaborative Study ◽  
Muscarinic Agonists ◽  
Eular Recommendations ◽  
Logical Sequence ◽  
Patient Representatives ◽  
Saliva Substitutes

The therapeutic management of Sjögren syndrome (SjS) has not changed substantially in recent decades: treatment decisions remain challenging in clinical practice, without a specific therapeutic target beyond the relief of symptoms as the most important goal. In view of this scenario, the European League Against Rheumatism (EULAR) promoted and supported an international collaborative study (EULAR SS Task Force) aimed at developing the first EULAR evidence and consensus-based recommendations for the management of patients with SjS with topical and systemic medications. The aim was to develop a rational therapeutic approach to SjS patients useful for healthcare professionals, physicians undergoing specialist training, medical students, the pharmaceutical industry and drug regulatory organisations following the 2014 EULAR standardised operating procedures. The Task Force (TF) included specialists in rheumatology, internal medicine, oral health, ophthalmology, gynaecology, dermatology and epidemiology, statisticians, general practitioners, nurses and patient representatives from 30 countries of the 5 continents. Evidence was collected from studies including primary SjS patients fulfilling the 2002/2016 criteria; when no evidence was available, evidence from studies including associated SjS or patients fulfilling previous sets of criteria was considered and extrapolated. The TF endorsed the presentation of general principles for the management of patients with SjS as three overarching, general consensus-based recommendations and 12 specific recommendations that form a logical sequence, starting with the management of the central triplet of symptoms (dryness, fatigue and pain) followed by the management of systemic disease. The recommendations address the use of topical oral (saliva substitutes) and ocular (artificial tear drops, topical non-steroidal anti-inflammatory drugs, topical corticosteroids, topical CyA, serum tear drops) therapies, oral muscarinic agonists (pilocarpine, cevimeline), hydroxychloroquine, oral glucocorticoids, synthetic immunosuppressive agents (cyclophosphamide, azathioprine, methotrexate, leflunomide and mycophenolate), and biological therapies (rituximab, abatacept and belimumab). For each recommendation, levels of evidence (mostly modest) and TF agreement (mostly very high) are provided. The 2019 EULAR recommendations are based on the evidence collected in the last 16 years in the management of primary 2002 SjS patients and on discussions between a large and broadly international TF. The recommendations synthesise current thinking on SjS treatment in a set of overarching principles and recommendations. We hope that the current recommendations will be broadly applied in clinical practice and/or serve as a template for national societies to develop local recommendations.

PS02.177: EFFECT OF PREHABILITATION ON FITNESS IN PATIENTS UNDERGOING NEOADJUVANT TREATMENT AND OESOPHAGOGASTRIC CANCER SURGERY: A RANDOMISED CONTROLLED TRIAL

2018 ◽  
Vol 31 (Supplement_1) ◽  
pp. 172-172
Author(s):  
Sophie Allen ◽  
Vanessa Brown ◽  
Pradeep Prabhu ◽  
Timothy Rockall ◽  
Shaun Preston ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Standard Care ◽  
Conflicts Of Interest ◽  
Controlled Trial ◽  
Recovery Period ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Drop Out ◽  
Home Exercise ◽  
Randomised Controlled

Abstract Background Neoadjuvant chemotherapy (NAC) and surgery improves 5-year survival in patients with locally-advanced oesophagogastric (OG) cancer. NAC reduces fitness as assessed by cardiopulmonary exercise (CPX) testing. We aim to demonstrate improvement in CPX test performance in patients undergoing a 15-week ‘prehabilitation’ programme during and after NAC, compared those receiving ‘standard care’. Methods A single-centre, parallel-arm randomised controlled trial was conducted in patients undergoing NAC for OG cancer. Patients were assigned to a 15-week prehabilitation programme comprising twice weekly supervised aerobic and resistance training, a thrice weekly home exercise plan, and 6 Medical Coaching sessions (Prehab), or standard care (Control). CPX was performed at baseline (before NAC; Test 1), 2 weeks following NAC completion (Test 2), and during the preoperative week (Test 3). The primary outcome (anaerobic threshold (AT)) is powered for 48 patients (24 per group). Secondary outcomes include peak oxygen uptake (pVO2) and work rate (WR). Results Since December 2016, 46 patients have been recruited, with a 15% drop-out rate (7/46). All patients received NAC. To date, complete dataset is available for 27 subjects (Prehab n = 15; Control n = 12). Groups were matched for baseline demographics and AT/pVO2/WR (P = ns). At baseline: Mean AT 13.3 ± 2.91ml/kg/min, pVO2 797.85 ± 168.04ml/min/m2, and WR 148.63 ± 40.18watts. Effects of NAC (Tests 1 to 2): All subjects had a mean decline in AT (Prehab -1.41ml/kg/min vs. Control -1.69 ml/kg/min) with no difference in WR decline (Prehab -9.87watts vs. Control -9.66watts; P = 0.98). At Test 2, there was a trend towards pVO2 improvement with Prehab (+ 20.2ml/min/m2) whereas pVO2 in Controls deteriorated (-81.98ml/min/m2; P = 0.06). Effects of NAC and 5-week ‘recovery period’ (Tests 1 to 3): There was a tendency towards a smaller AT decrease from baseline with Prehab subjects (-0.6ml/kg/min) compared with Controls (-1.5ml/kg/min; P = 0.30). Compared with Test 1, Prehab patients demonstrated a non-significant trend towards improvement in pVO2 (+ 20.2ml/min/m2) and WR (+ 1.86watts) following a period of recovery. Controls observed a decrease in both parameters (pVO2 -16.48ml/min/m2, WR -3.5watts). Conclusion A prehabilitation programme is feasible during and after NAC. Interim analysis demonstrates a trend towards return of baseline pVO2 in patients receiving prehabilitation. Trial completion is warranted and the full dataset will be available by June 2018. Disclosure All authors have declared no conflicts of interest.

scholarly journals Targeted, structured text messaging to improve dietary and lifestyle behaviours for people on maintenance haemodialysis (KIDNEYTEXT): study protocol for a randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e023545 ◽  
Author(s):  
Jessica Stevenson ◽  
Katrina L Campbell ◽  
Mark Brown ◽  
Jonathan Craig ◽  
Kirsten Howard ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Text Messaging ◽  
Controlled Trial ◽  
Intervention Group ◽  
Text Messages ◽  
Dietary Guidelines ◽  
Drop Out ◽  
Local Health ◽  
Lifestyle Behaviours ◽  
Randomised Controlled

IntroductionManaging nutrition is critical for reducing morbidity and mortality in patients on haemodialysis but adherence to the complex dietary restrictions remains problematic. Innovative interventions to enhance the delivery of nutritional care are needed. The aim of this phase II trial is to evaluate the feasibility and effectiveness of a targeted mobile phone text messaging system to improve dietary and lifestyle behaviours in patients on long-term haemodialysis.Methods and analysisSingle-blinded randomised controlled trial with 6 months of follow-up in 130 patients on haemodialysis who will be randomised to either standard care or KIDNEYTEXT. The KIDNEYTEXT intervention group will receive three text messages per week for 6 months. The text messages provide customised dietary information and advice based on renal dietary guidelines and general healthy eating dietary guidelines, and motivation and support to improve behaviours. The primary outcome is feasibility including recruitment rate, drop-out rate, adherence to renal dietary recommendations, participant satisfaction and a process evaluation using semistructured interviews with a subset of purposively sampled participants. Secondary and exploratory outcomes include a range of clinical and behavioural outcomes and a healthcare utilisation cost analysis will be undertaken.Ethics and disseminationThe study has been approved by the Western Sydney Local Health District Human Research Ethics Committee—Westmead. Results will be presented at scientific meetings and published in peer-reviewed publications.Trial registration numberACTRN12617001084370; Pre-results.

scholarly journals Supervised pulmonary tele-rehabilitation versus pulmonary rehabilitation in severe COPD: a randomised multicentre trial

Thorax ◽  
2020 ◽  
Vol 75 (5) ◽  
pp. 413-421 ◽  
Author(s):  
Henrik Hansen ◽  
Theresa Bieler ◽  
Nina Beyer ◽  
Thomas Kallemose ◽  
Jon Torgny Wilcke ◽  
...  
Keyword(s):  
Pulmonary Rehabilitation ◽  
Controlled Trial ◽  
Drop Out ◽  
Group Differences ◽  
Primary Analysis ◽  
Intention To Treat ◽  
Registration Number ◽  
Randomised Controlled

RationalePulmonary rehabilitation (PR) is an effective, key standard treatment for people with COPD. Nevertheless, low participant uptake, insufficient attendance and high drop-out rates are reported. Investigation is warranted of the benefits achieved through alternative approaches, such as pulmonary tele-rehabilitation (PTR).ObjectiveTo investigate whether PTR is superior to conventional PR on 6 min walk distance (6MWD) and secondarily on respiratory symptoms, quality of life, physical activity and lower limb muscle function in patients with COPD and FEV1 <50% eligible for routine hospital-based, outpatient PR.MethodsIn this single-blinded, multicentre, superiority randomised controlled trial, patients were assigned 1:1 to 10 weeks of groups-based PTR (60 min, three times weekly) or conventional PR (90 min, two times weekly). Assessments were performed by blinded assessors at baseline, end of intervention and at 22 weeks’ follow-up from baseline. The primary analysis was based on the intention-to-treat principle.Measurements and main resultsThe primary outcome was change in 6MWD from baseline to 10 weeks; 134 participants (74 females, mean±SD age 68±9 years, FEV1 33%±9% predicted, 6MWD 327±103 metres) were included and randomised. The analysis showed no between-group differences for changes in 6MWD after intervention (9.2 metres (95% CI: −6.6 to 24.9)) or at 22 weeks’ follow-up (−5.3 metres (95% CI: −28.9 to 18.3)). More participants completed the PTR intervention (n=57) than conventional PR (n=43) (χ2 test p<0.01).ConclusionPTR was not superior to conventional PR on the 6MWD and we found no differences between groups. As more participants completed PTR, supervised PTR would be relevant to compare with conventional PR in a non-inferiority design.Trial registration numberClinicalTrials.gov (NCT02667171), 28 January 2016.

scholarly journals A Study to Inform the Design of a National Multicentre Randomised Controlled Trial to Evaluate If Reducing Serum Phosphate to Normal Levels Improves Clinical Outcomes including Mortality, Cardiovascular Events, Bone Pain, or Fracture in Patients on Dialysis

2015 ◽  
Vol 2015 ◽  
pp. 1-12 ◽  
Author(s):  
Ramya Bhargava ◽  
Philip A. Kalra ◽  
Paul Brenchley ◽  
Helen Hurst ◽  
Alastair Hutchison
Keyword(s):  
Randomised Controlled Trial ◽  
Clinical Outcomes ◽  
Cardiovascular Events ◽  
Controlled Trial ◽  
Drop Out ◽  
Phosphate Binders ◽  
Dialysis Patients ◽  
Definitive Trial ◽  
Registration Number ◽  
Randomised Controlled

Background. Retrospective, observational studies link high phosphate with mortality in dialysis patients. This generates research hypotheses but does not establish “cause-and-effect.” A large randomised controlled trial (RCT) of about 3000 patients randomised 50 : 50 to lower or higher phosphate ranges is required to answer the key question: does reducing phosphate levels improve clinical outcomes? Whether such a trial is technically possible is unknown; therefore, a study is necessary to inform the design and conduct of a future, definitive trial.Methodology. Dual centre prospective parallel group study: 100 dialysis patients randomized to lower (phosphate target 0.8 to 1.4 mmol/L) or higher range group (1.8 to 2.4 mmol/L). Non-calcium-containing phosphate binders and questionnaires will be used to achieve target phosphate. Primary endpoint: percentage successfully titrated to required range and percentage maintained in these groups over the maintenance period. Secondary endpoints: consent rate, drop-out rates, and cardiovascular events.Discussion. This study will inform design of a large definitive trial of the effect of phosphate on mortality and cardiovascular events in dialysis patients. If phosphate lowering improves outcomes, we would be reassured of the validity of this clinical practice. If, on the other hand, there is no improvement, a reassessment of resource allocation to therapies proven to improve outcomes will result.Trial Registration Number. This trial is registered with ISRCTN registration numberISRCTN24741445.

Impact of using different predictive equations on the prevalence of chronic byssinosis in textile workers in Pakistan

2021 ◽  
pp. oemed-2021-107680
Author(s):  
Asaad Ahmed Nafees ◽  
Muhammad Zia Muneer ◽  
Sara De Matteis ◽  
Andre Amaral ◽  
Peter Burney ◽  
...  
Keyword(s):  
Lung Function ◽  
Controlled Trial ◽  
Forced Expiratory Volume ◽  
Textile Workers ◽  
Middle Income ◽  
Low Middle Income Countries ◽  
Reference Equations ◽  
Predicted Values ◽  
Definition Of ◽  
Randomised Controlled

ObjectiveByssinosis remains a significant problem among textile workers in low/middle-income countries. Here we share our experience of using different prediction equations for assessing ‘chronic’ byssinosis according to the standard WHO classification using measurements of forced expiratory volume in 1 s (FEV1).MethodsWe enrolled 1910 workers in a randomised controlled trial of an intervention to improve the health of textile workers in Pakistan. We included in analyses the 1724 (90%) men who performed pre-bronchodilator spirometry tests of acceptable quality. We compared four different equations for deriving lung function percentage predicted values among those with symptoms-based byssinosis: the third US National Health and Nutrition Examination Survey (NHANES-III, with ‘North Indian and Pakistani’ conversion factor); the Global Lung Function Initiative (GLI, ‘other or mixed ethnicities’); a recent equation derived from survey of a western Indian population; and one based on an older and smaller survey of Karachi residents.Results58 men (3.4%) had symptoms-based byssinosis according to WHO criteria. Of these, the proportions with a reduced FEV1 (<80% predicted) identified using NHANES and GLI; Indian and Pakistani reference equations were 40%, 41%, 14% and 12%, respectively. Much of this variation was eliminated when we substituted FEV1/forced vital capacity (FVC) ratio (<lower limit of normality) as a measure of airway obstruction.ConclusionAccurate measures of occupational disease frequency and distribution require approaches that are both standardised and meaningful. We should reconsider the WHO definition of ‘chronic’ byssinosis based on changes in FEV1, and instead use the FEV1/FVC.

scholarly journals 2018 EULAR recommendations for physical activity in people with inflammatory arthritis and osteoarthritis

2018 ◽  
Vol 77 (9) ◽  
pp. 1251-1260 ◽  
Author(s):  
Anne-Kathrin Rausch Osthoff ◽  
Karin Niedermann ◽  
Jürgen Braun ◽  
Jo Adams ◽  
Nina Brodin ◽  
...  
Keyword(s):  
Physical Activity ◽  
Inflammatory Arthritis ◽  
Musculoskeletal Diseases ◽  
Task Force ◽  
The Public ◽  
Knee Oa ◽  
Eular Recommendations ◽  
Patient Representatives ◽  
Research And Education ◽  
Level Of Agreement

Regular physical activity (PA) is increasingly promoted for people with rheumatic and musculoskeletal diseases as well as the general population. We evaluated if the public health recommendations for PA are applicable for people with inflammatory arthritis (iA; Rheumatoid Arthritis and Spondyloarthritis) and osteoarthritis (hip/knee OA) in order to develop evidence-based recommendations for advice and guidance on PA in clinical practice. The EULAR standardised operating procedures for the development of recommendations were followed. A task force (TF) (including rheumatologists, other medical specialists and physicians, health professionals, patient-representatives, methodologists) from 16 countries met twice. In the first TF meeting, 13 research questions to support a systematic literature review (SLR) were identified and defined. In the second meeting, the SLR evidence was presented and discussed before the recommendations, research agenda and education agenda were formulated. The TF developed and agreed on four overarching principles and 10 recommendations for PA in people with iA and OA. The mean level of agreement between the TF members ranged between 9.8 and 8.8. Given the evidence for its effectiveness, feasibility and safety, PA is advocated as integral part of standard care throughout the course of these diseases. Finally, the TF agreed on related research and education agendas. Evidence and expert opinion inform these recommendations to provide guidance in the development, conduct and evaluation of PA-interventions and promotion in people with iA and OA. It is advised that these recommendations should be implemented considering individual needs and national health systems.

scholarly journals 2018 Update of the EULAR recommendations for the management of large vessel vasculitis

2019 ◽  
Vol 79 (1) ◽  
pp. 19-30 ◽  
Author(s):  
Bernhard Hellmich ◽  
Ana Agueda ◽  
Sara Monti ◽  
Frank Buttgereit ◽  
Hubert de Boysson ◽  
...  
Keyword(s):  
Task Force ◽  
Scientific Evidence ◽  
Clinical Care ◽  
Large Vessel Vasculitis ◽  
Large Vessel ◽  
High Dose ◽  
Eular Recommendations ◽  
European League Against Rheumatism ◽  
Increased Risk ◽  
European League

BackgroundSince the publication of the European League Against Rheumatism (EULAR) recommendations for the management of large vessel vasculitis (LVV) in 2009, several relevant randomised clinical trials and cohort analyses have been published, which have the potential to change clinical care and therefore supporting the need to update the original recommendations.MethodsUsing EULAR standardised operating procedures for EULAR-endorsed recommendations, the EULAR task force undertook a systematic literature review and sought opinion from 20 experts from 13 countries. We modified existing recommendations and created new recommendations.ResultsThree overarching principles and 10 recommendations were formulated. We recommend that a suspected diagnosis of LVV should be confirmed by imaging or histology. High dose glucocorticoid therapy (40–60 mg/day prednisone-equivalent) should be initiated immediately for induction of remission in active giant cell arteritis (GCA) or Takayasu arteritis (TAK). We recommend adjunctive therapy in selected patients with GCA (refractory or relapsing disease, presence of an increased risk for glucocorticoid-related adverse events or complications) using tocilizumab. Methotrexate may be used as an alternative. Non-biological glucocorticoid-sparing agents should be given in combination with glucocorticoids in all patients with TAK and biological agents may be used in refractory or relapsing patients. We no longer recommend the routine use of antiplatelet or anticoagulant therapy for treatment of LVV unless it is indicated for other reasons.ConclusionsWe have updated the recommendations for the management of LVV to facilitate the translation of current scientific evidence and expert opinion into better management and improved outcome of patients in clinical practice.

scholarly journals European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update

2015 ◽  
Vol 75 (3) ◽  
pp. 499-510 ◽  
Author(s):  
L Gossec ◽  
J S Smolen ◽  
S Ramiro ◽  
M de Wit ◽  
M Cutolo ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Expert Opinion ◽  
Pharmacological Treatment ◽  
Task Force ◽  
Local Therapy ◽  
Initial Therapy ◽  
Tnf Inhibitor ◽  
Eular Recommendations ◽  
European League Against Rheumatism ◽  
European League

BackgroundSince the publication of the European League Against Rheumatism recommendations for the pharmacological treatment of psoriatic arthritis (PsA) in 2012, new evidence and new therapeutic agents have emerged. The objective was to update these recommendations.MethodsA systematic literature review was performed regarding pharmacological treatment in PsA. Subsequently, recommendations were formulated based on the evidence and the expert opinion of the 34 Task Force members. Levels of evidence and strengths of recommendations were allocated.ResultsThe updated recommendations comprise 5 overarching principles and 10 recommendations, covering pharmacological therapies for PsA from non-steroidal anti-inflammatory drugs (NSAIDs), to conventional synthetic (csDMARD) and biological (bDMARD) disease-modifying antirheumatic drugs, whatever their mode of action, taking articular and extra-articular manifestations of PsA into account, but focusing on musculoskeletal involvement. The overarching principles address the need for shared decision-making and treatment objectives. The recommendations address csDMARDs as an initial therapy after failure of NSAIDs and local therapy for active disease, followed, if necessary, by a bDMARD or a targeted synthetic DMARD (tsDMARD). The first bDMARD would usually be a tumour necrosis factor (TNF) inhibitor. bDMARDs targeting interleukin (IL)12/23 (ustekinumab) or IL-17 pathways (secukinumab) may be used in patients for whom TNF inhibitors are inappropriate and a tsDMARD such as a phosphodiesterase 4-inhibitor (apremilast) if bDMARDs are inappropriate. If the first bDMARD strategy fails, any other bDMARD or tsDMARD may be used.ConclusionsThese recommendations provide stakeholders with an updated consensus on the pharmacological treatment of PsA and strategies to reach optimal outcomes in PsA, based on a combination of evidence and expert opinion.

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