Etanercept therapy in rheumatoid arthritis and the risk of malignancies: a systematic review and individual patient data meta-analysis of randomised controlled trials

2008 ◽  
Vol 68 (7) ◽  
pp. 1177-1183 ◽  
Author(s):  
T Bongartz ◽  
F C Warren ◽  
D Mines ◽  
E L Matteson ◽  
K R Abrams ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Controlled Trials ◽  
Etanercept Therapy ◽  
Randomised Controlled

scholarly journals Vasopressin in septic shock: an individual patient data meta-analysis of randomised controlled trials

2019 ◽  
Vol 45 (6) ◽  
pp. 844-855 ◽  
Author(s):  
Myura Nagendran ◽  
James A. Russell ◽  
Keith R. Walley ◽  
Stephen J. Brett ◽  
Gavin D. Perkins ◽  
...  
Keyword(s):  
Septic Shock ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Controlled Trials ◽  
Randomised Controlled

scholarly journals Lowering blood pressure after acute intracerebral haemorrhage: protocol for a systematic review and meta-analysis using individual patient data from randomised controlled trials participating in the Blood Pressure in Acute Stroke Collaboration (BASC)

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e030121 ◽  
Author(s):  
Tom J Moullaali ◽  
Xia Wang ◽  
Lisa J Woodhouse ◽  
Zhe Kang Law ◽  
Candice Delcourt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Blood Pressure ◽  
Acute Stroke ◽  
Intracerebral Haemorrhage ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Patient Data ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomised Controlled

IntroductionConflicting results from multiple randomised trials indicate that the methods and effects of blood pressure (BP) reduction after acute intracerebral haemorrhage (ICH) are complex. The Blood pressure in Acute Stroke Collaboration is an international collaboration, which aims to determine the optimal management of BP after acute stroke including ICH.Methods and analysisA systematic review will be undertaken according to the Preferred Reporting Items for Systematic review and Meta-Analysis of Individual Participant Data (IPD) guideline. A search of Cochrane Central Register of Controlled Trials, EMBASE and MEDLINE from inception will be conducted to identify randomised controlled trials of BP management in adults with acute spontaneous (non-traumatic) ICH enrolled within the first 7 days of symptom onset. Authors of studies that meet the inclusion criteria will be invited to share their IPD. The primary outcome will be functional outcome according to the modified Rankin Scale. Safety outcomes will be early neurological deterioration, symptomatic hypotension and serious adverse events. Secondary outcomes will include death and neuroradiological and haemodynamic variables. Meta-analyses of pooled IPD using the intention-to-treat dataset of included trials, including subgroup analyses to assess modification of the effects of BP lowering by time to treatment, treatment strategy and patient’s demographic, clinical and prestroke neuroradiological characteristics.Ethics and disseminationNo new patient data will be collected nor is there any deviation from the original purposes of each study where ethical approvals were granted; therefore, further ethical approval is not required. Results will be reported in international peer-reviewed journals.PROSPERO registration numberCRD42019141136.

scholarly journals Data sharing: experience of accessing individual patient data from completed randomised controlled trials in vascular and cognitive medicine

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e038765
Author(s):  
Polly Scutt ◽  
Lisa J Woodhouse ◽  
Alan A Montgomery ◽  
Philip M Bath
Keyword(s):  
Outcome Measures ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Secondary Outcome ◽  
Controlled Trials ◽  
Randomised Trials ◽  
Vascular Events ◽  
Randomised Controlled

ObjectivesMeta-analysis based on individual patient data (IPD) from randomised trials is superior to using published summary data since it facilitates subgroup and multiple variable analyses. Guidelines and funders expect that researchers share IPD for bona fide analyses, but in practice, this is done variably. Here, we report the experience of obtaining IPD for two collaborative analysis studies.SettingTwo linked studies required IPD from published randomised trials. The leading researchers for eligible trials were approached and asked to share IPD including trial characteristics, patient demographics, baseline clinical data and outcome measures.ParticipantsParticipants in eligible randomised controlled trials included patients with or at risk of cognitive decline/vascular events.Primary and secondary outcome measuresNumbers (%) of trials where the leading researcher responded favourably/negatively or did not respond. If negative, reasons behind the response were collected. If positive, methods used to share IPD were recorded.ResultsAcross the two studies, 391 completed trials were identified. Email addresses for researchers were found for 313 (80%) of the trials. One hundred and forty-eight (47%) researchers did not respond despite being sent multiple emails. Following contact, positive initial responses were received from 92 researchers, resulting in IPD being shared for 78 trials. Eighty-seven (28%) researchers declined to share data; justifications were recorded. The median time from first request to accessing data in one study was 241 (IQR 383.3) days. IPD sources included: direct from researcher, via academic trial funders repository and a website requiring remote analysis of commercial data. Where data were shared, a variety of methods were used to transfer data.ConclusionSharing of IPD from trials is desirable and a requirement of many funding bodies. However, accessing IPD faces multiple challenges including refusals to share, delays in access to data and having to perform analyses on a remote website.Trial registrationNot applicable.

scholarly journals Predictors of response to TNF inhibitors in rheumatoid arthritis: an individual patient data pooled analysis of randomised controlled trials

RMD Open ◽  
2021 ◽  
Vol 7 (3) ◽  
pp. e001882
Author(s):  
Johan Law-Wan ◽  
Marc-Antoine Sparfel ◽  
Sophie Derolez ◽  
Nicolas Azzopardi ◽  
Philippe Goupille ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Treatment Group ◽  
Disease Activity ◽  
Randomised Controlled Trials ◽  
Disease Duration ◽  
Individual Patient Data ◽  
Patient Data ◽  
Response To Treatment ◽  
Controlled Trials ◽  
Randomised Controlled

ObjectiveTo identify patient characteristics associated with responsiveness to tumour necrosis factor inhibitors (TNFi) in rheumatoid arthritis (RA).Materials and methodsIndividual patient data from 29 randomised controlled trials (RCTs) evaluating the efficacy of a TNFi versus placebo or conventional therapy were obtained. Response to treatment was assessed in subgroups according to the following baseline characteristics: smoking status, physical activity, sex, age, body mass index, autoantibody profile, disease duration, high initial disease activity defined by Disease Activity Score on 28 joints (DAS28)(C reactive protein (CRP)) >5.1. The primary outcome was the between-treatment group difference in DAS28(CRP) change from baseline to 6 months. The secondary endpoints were the between-treatment group difference in final DAS28(CRP) measured until 6 months and EULAR response criteria until 6 months. Data from each RCT were then pooled by the Mantel-Haenszel method using a random effects model. A linear metaregression was also carried out on two data-sharing platforms separately to support the results.ResultsIndividual data of 11 617 patients from 29 RCTs were analysed. Until 6 months, a significantly higher EULAR non-response rate was observed in obese patients (OR 0.52 vs 0.36 for non-obese, p=0.01). A multivariable regression model performed on 7457 patients indicated that patients treated by TNFi had a final DAS28(CRP) decreased by 0.02 for each year of disease duration (p<0.001), and a 0.21 decreased for patients with a baseline DAS28(CRP) >5.1 (p<0.001).ConclusionsIn RA, patients who are more responsive to TNFi are those who are non-obese, have a long disease duration and have a high initial disease activity.

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