scholarly journals Response to physical rehabilitation and recovery trajectories following critical illness: individual participant data meta-analysis protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e035613
Author(s):  
Jennifer R A Jones ◽  
Sue Berney ◽  
Michael J Berry ◽  
D Clark Files ◽  
David M Griffith ◽  
...  

IntroductionThe number of inconclusive physical rehabilitation randomised controlled trials for patients with critical illness is increasing. Evidence suggests critical illness patient subgroups may exist that benefit from targeted physical rehabilitation interventions that could improve their recovery trajectory. We aim to identify critical illness patient subgroups that respond to physical rehabilitation and map recovery trajectories according to physical function and quality of life outcomes. Additionally, the utilisation of healthcare resources will be examined for subgroups identified.Methods and analysisThis is an individual participant data meta-analysis protocol. A systematic literature review was conducted for randomised controlled trials that delivered additional physical rehabilitation for patients with critical illness during their acute hospital stay, assessed chronic disease burden, with a minimum follow-up period of 3 months measuring performance-based physical function and health-related quality of life outcomes. From 2178 records retrieved in the systematic literature review, four eligible trials were identified by two independent reviewers. Principal investigators of eligible trials were invited to contribute their data to this individual participant data meta-analysis. Risk of bias will be assessed (Cochrane risk of bias tool for randomised trials). Participant and trial characteristics, interventions and outcomes data of included studies will be summarised. Meta-analyses will entail a one-stage model, which will account for the heterogeneity across and the clustering between studies. Multiple imputation using chained equations will be used to account for the missing data.Ethics and disseminationThis individual participant data meta-analysis does not require ethical review as anonymised participant data will be used and no new data collected. Additionally, eligible trials were granted approval by institutional review boards or research ethics committees and informed consent was provided for participants. Data sharing agreements are in place permitting contribution of data. The study findings will be disseminated at conferences and through peer-reviewed publications.PROSPERO registration numberCRD42019152526.

2020 ◽  
Author(s):  
Or Dagan ◽  
Pasco Fearon ◽  
Carlo Schuengel ◽  
Marije Verhage ◽  
Glenn I. Roisman ◽  
...  

Since the seminal 1992 paper by van IJzendoorn, Sagi, and Lambermon, putting forward the “The multiple caretaker paradox”, relatively little attention has been given to the potential joint effects of the role early attachment network to mother and father play in development. Recently, Dagan and Sagi-Schwartz (2018) have published a paper that attempts to revive this unsettled issue, calling for research on the subject and offering a framework for posing attachment network hypotheses. This Collaboration for Attachment Research Synthesis project attempts to use an Individual Participant Data meta-analyses to test the hypotheses put forward in Dagan and Sagi-Schwartz (2018). Specifically, we test (a) whether the number of secure attachments (0,1, or 2) matter in predicting a range of developmental outcomes, and (b) whether the quality of attachment relationship with one parent contributes more than the other to these outcomes.


2021 ◽  
Author(s):  
Jean-Charles Roy ◽  
Chloé Rousseau ◽  
Alexis Jutel ◽  
Florian Naudet ◽  
Gabriel Robert

Abstract BackgroundDuloxetine is an antidepressant that benefits from a wide range of approval in the elderly population, while its safety for use in the elderly population, compared to younger adults, is not clearly assessed. This protocol outlines a systematic review and individual participant data meta-analysis comparing the tolerability of duloxetine between elderly and younger adults. MethodsOnly randomised controlled clinical trials, comparing duloxetine to placebo, will be included in this meta-analysis. The studies will be selected if participants were adults of less and more than 65 years old, in conditions of use of duloxetine approved by the European Medical Agency (EMA) and the Food and Drug Administration (FDA). The primary outcome will be the rate ratio of serious adverse events under duloxetine compared to placebo, between participants at least 65 years old and younger adults. Second, the number of any adverse events, clinical efficacy and quality of life will be compared between elderly and younger adults under both interventions. The quality of evidence in the tolerability of duloxetine will be assessed using the GRADE system. A two-step random effect meta-analysis will be conducted. Preliminary searches and formal screening of search results against eligibility criteria on have been completed using predefined search term on electronic databases. DiscussionThis study represents the first meta-analysis investigating the safety of duloxetine in the elderly population across all conditions approved by European and American regulatory authorities. The results from this meta-analysis are intended to help prescribers to provide better care for the elderly population.Systematic review registrationThe protocol has been registered at the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42019130488).


Thorax ◽  
2021 ◽  
pp. thoraxjnl-2020-215613
Author(s):  
Marius Lebret ◽  
Antoine Léotard ◽  
Jean Louis Pépin ◽  
Wolfram Windisch ◽  
Emelie Ekkernkamp ◽  
...  

BackgroundThe optimal interface for the delivery of home non-invasive ventilation (NIV) to treat chronic respiratory failure has not yet been determined. The aim of this individual participant data (IPD) meta-analysis was to compare the effect of nasal and oronasal masks on treatment efficacy and adherence in patients with COPD and obesity hypoventilation syndrome (OHS).MethodsWe searched Medline and Cochrane Central Register of Controlled Trials for prospective randomised controlled trials (RCTs) of at least 1 month’s duration, published between January 1994 and April 2019, that assessed NIV efficacy in patients with OHS and COPD. The main outcomes were diurnal PaCO2, PaO2 and NIV adherence (PROSPERO CRD42019132398).FindingsOf 1576 articles identified, 34 RCTs met the inclusion criteria and IPD were obtained for 18. Ten RCTs were excluded because only one type of mask was used, or mask data were missing. Data from 8 RCTs, including 290 IPD, underwent meta-analysis. Oronasal masks were used in 86% of cases. There were no differences between oronasal and nasal masks for PaCO2 (0.61 mm Hg (95% CI −2.15 to 3.38); p=0.68), PaO2 (−0.00 mm Hg (95% CI −4.59 to 4.58); p=1) or NIV adherence (0·29 hour/day (95% CI −0.74 to 1.32); p=0.58). There was no interaction between the underlying pathology and the effect of mask type on any outcome.InterpretationOronasal masks are the most used interface for the delivery of home NIV in patients with OHS and COPD; however, there is no difference in the efficacy or tolerance of oronasal or nasal masks.


2020 ◽  
Author(s):  
Kurinchi Selvan Gurusamy ◽  
Claire Vale ◽  
Elena Pizzo ◽  
R Bhanot ◽  
Brian Davidson ◽  
...  

Abstract Background There is uncertainty about whether cytoreductive surgery (CRS) + hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared to standard of care (SoC) in people with peritoneal metastases who can withstand major surgery. Primary objectives To compare the relative benefits and harms of CRS+HIPEC versus SoC in people with peritoneal metastases from colorectal, ovarian, or gastric cancers eligible to undergo CRS+HIPEC by a systematic review and individual participant data (IPD) meta-analysis. Secondary objectives To compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services (PSS) perspective using a model-based cost-utility analysis. Methods We will perform a systematic review of literature by updating the searches from MEDLINE, EMBASE, Cochrane library, Science Citation Index as well as trial registers. Two members of our team will independently screen the search results and identify randomised controlled trials (RCTs) comparing CRS+HIPEC versus SoC for inclusion based on full texts for articles shortlisted during screening. We will assess the risk of bias in the trials and obtain data related to baseline prognostic characteristics, details of how CRS+HIPEC and SoC were performed, how long people were followed-up, and outcome data related to overall survival, disease progression, health-related quality of life, treatment related complications, and resource utilisation data by contacting the study authors and obtaining data at the individual participant level. Using individual participant data (IPD), we will perform a two-step IPD, i.e. calculate the adjusted effect estimate from each included study and then perform a random-effects model meta-analysis. We will perform various subgroup analyses and metaregression to investigate potential sources of heterogeneity and identify whether a subset of participants benefits from CRS+HIPEC and perform sensitivity analyses to test the robustness of results to assumptions. We will also perform a model-based cost-utility analysis to assess whether CRS+HIPEC is cost-effective in the NHS setting.


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