A score for predicting risk of death from cardiovascular disease in adults with raised blood pressure, based on individual patient data from randomised controlled trials

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.

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Obtaining Individual Patient Data from Randomised Controlled Trials

Systematic Reviews in Health Care ◽

10.1002/9780470693926.ch6 ◽

2008 ◽

pp. 109-121 ◽

Cited By ~ 23

Author(s):

Michael J Clarke ◽

Lesley A Stewart

Keyword(s):

Randomised Controlled Trials ◽

Individual Patient Data ◽

Patient Data ◽

Controlled Trials ◽

Randomised Controlled

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

BMJ Open ◽

10.1136/bmjopen-2020-038765 ◽

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.

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