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 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 Comprehensive database and individual patient data meta-analysis of randomised controlled trials on psychotherapies reducing suicidal thoughts and behaviour: study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e037566
Author(s):  
Mandy Xian Hu ◽  
Christina Palantza ◽  
Kim Setkowski ◽  
Renske Gilissen ◽  
Eirini Karyotaki ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Suicidal Thoughts ◽  
Comprehensive Database ◽  
Randomised Controlled

IntroductionPsychotherapy may reduce suicidal thoughts and behaviour, but its effectiveness is not well examined. Furthermore, conventional meta-analyses are unable to test possible effects of moderators affecting this relationship. This protocol outlines the building of a comprehensive database of the literature in this research field. In addition, we will conduct an individual patient data meta-analysis (IPD-MA) to establish the effectiveness of psychotherapy in reducing suicidality, and to examine which factors moderate the efficacy of these interventions.Methods and analysisTo build a comprehensive database, randomised controlled trials examining the effect of any psychotherapy targeting any psychiatric disorder on suicidal thoughts or behaviour will be identified by running a systematic search in PubMed, Embase, PsycINFO, Web of Science, Scopus and The Cochrane Central Register of Controlled Trials from data inception to 12 August 2019. For the IPD-MA, we will focus on adult outpatients with suicidal ideation or behaviour. In addition, as a comparison group we will focus on a control group (waiting-list, care as usual or placebo). A 1-stage IPD-MA will be used to determine the effectiveness of psychotherapy on suicidal ideation, suicide attempts and/or suicide deaths, and to investigate potential patient-related and intervention-related moderators. Subgroup and sensitivity analyses will be conducted to test the robustness of the findings. Additionally, a conventional MA will be conducted to determine the differences between studies that provided IPD and those that did not. IPD-MA may determine the effectiveness of psychotherapy in reducing suicidality and provide insights into the moderating factors influencing the efficacy of psychotherapy. Answering these questions will inform mental healthcare practitioners about optimal treatments for different groups of individuals with suicidal ideation and/or behaviour and consequently help to reduce suicide risk.Ethics and disseminationAn ethical approval is not required for this study. The results will be published in a peer-review journal.PROSPERO registration numberCRD42020140573

Fever control in critically ill adults. An individual patient data meta-analysis of randomised controlled trials

2019 ◽  
Vol 45 (4) ◽  
pp. 468-476 ◽  
Author(s):  
Paul J. Young ◽  
Rinaldo Bellomo ◽  
Gordon R. Bernard ◽  
Daniel J. Niven ◽  
Frederique Schortgen ◽  
...  
Keyword(s):  
Critically Ill ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
Critically Ill Adults ◽  
Ill Adults

Abstract TMP40: Pharyngeal Electrical Stimulation for Early Decannulation in Tracheotomised Stroke Patients With Dysphagia: A Meta-analysis of Individual Patient Data From Randomised Controlled Trials

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Philip M Bath ◽  
Lisa J Woodhouse ◽  
Sonja Suntrup-Krueger ◽  
Shaheen Hamdy ◽  
Rainer Dziewas
Keyword(s):  
Electrical Stimulation ◽  
Randomised Controlled Trials ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Hospital Length Of Stay ◽  
Controlled Trials ◽  
Stroke Severity ◽  
Stroke Patients ◽  
Randomised Controlled

Background: Dysphagia is common after stroke and associated with a poor outcome. Pharyngeal electrical stimulation (PES) increased decannulation rates in tracheotomised stroke patients with dysphagia following ventilation in two trials. We report the results of an individual patient data meta-analysis assessing PES in severely dysphagic tracheotomised stroke patients. Methods: We searched for randomised controlled trials of PES in dysphagic tracheotomised stroke patients and obtained individual patient data for demographic and clinical (stroke severity, NIHSS; functional oral intake scale, FOIS; decannulation) variables from trialists. Data are number (%), median [interquartile range], mean (standard deviation) and mean difference (MD) or odds ratio (OR) with 95% confidence intervals (CI). Results: Two completed trials were identified (n=30, PHAST-TRAC n=69 [funded by Phagenesis Ltd]), with data for 99 participants (PES 55, 56%; sham 44, 44%). Mean age 64 (13) years, female 40 (40%), NIHSS 18 [14-21], time from onset to randomisation 27 days [20-38], and FOIS=1 (nil by mouth). As compared with sham, PES was associated with an increased proportion of patients who were ready for early decannulation, 59% versus 11% (OR 11.4, 95% CI 3.86-33.33; p<0.001) and improved FOIS score at discharge (MD 1.13, 95% CI 0.25-2.00; p=0.011). Treated participants who were ready for decannulation tended to have a shorter hospital length of stay: 23 vs 41 days (p=0.070) than those who were not ready. No device-related serious adverse events were reported. Conclusions: PES was associated with an increased proportion of stroke patients who were ready for decannulation and less dysphagia, in two randomised trials.

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