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

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

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

Intensive Care Medicine ◽

10.1007/s00134-019-05620-2 ◽

2019 ◽

Vol 45 (6) ◽

pp. 844-855 ◽

Cited By ~ 22

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

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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 ◽

10.1136/bmjopen-2019-030121 ◽

2019 ◽

Vol 9 (7) ◽

pp. e030121 ◽

Cited By ~ 3

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.

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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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