scholarly journals Tolerability of Duloxetine in the Elderly and in Young Adults: A Protocol and Preliminary Results of a Systematic Review and Individual Participant Data Meta-Analysis of Randomised Placebo-Controlled Trials.

2021 ◽  
Author(s):  
Jean-Charles Roy ◽  
Chloé Rousseau ◽  
Alexis Jutel ◽  
Florian Naudet ◽  
Gabriel Robert
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Elderly Population ◽  
Meta Analysis ◽  
The Elderly ◽  
Search Term ◽  
Individual Participant Data ◽  
Younger Adults ◽  
Individual Participant

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).

scholarly journals Tolerability of duloxetine in the elderly and in adults: a protocol and preliminary results of a systematic review and individual participant data meta-analysis of randomized placebo-controlled trials

2020 ◽  
Author(s):  
Jean-Charles ROY ◽  
Chloé Rousseau ◽  
Alexis Jutel ◽  
Florian Naudet ◽  
Gabriel Robert
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Elderly Population ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Individual Participant Data ◽  
Younger Adults ◽  
Randomized Controlled ◽  
Individual Participant

Abstract Background. Duloxetine is an antidepressant which benefits from a wide range of approval in elderly population while its safety of use in elderly population, compared to younger adults, is not clearly assessed. A comparison of tolerability of duloxetine between elderly and younger adults would help to rule on this issue. Methods and Design. This protocol outlines a systematic review and meta-analysis of individual participant data (IPD) of all double-blind randomized controlled trials comparing the number of serious adverse events among individuals taking duloxetine in comparison to placebo between participants at least 65 years and younger adults in conditions approved by the European Medical Agency (EMA) and the Food Drug Administration (FDA). Secondarily, will be compared the number of any adverse events, clinical efficacy and quality of life between elderly and younger adults under duloxetine, in comparison to placebo. Relevant studies were selected on ClinicalTrials.gov, Clinicaltrialsregister.eu, data sharing platforms, FDA and EMA websites, and from systematic reviews and meta-analyses of duloxetine on PubMed, following Cochrane’s recommendations. Sponsors and authors from eligible studies were invited to share IPD on data sharing platform or directly with our research team. As data cannot be aggregate into a unique database, a two step-approach meta-analysis will be undertaken. Qualitative results from available data. 77 eligible randomized controlled trials were identified, representing 25303 participants. From online available data, 35 trials were assessed as being at an overall low risk of bias, 31 trials at an unclear risk of bias and 1 at high risk of bias. Evaluation of risk of bias was not feasible for 10 studies. Conclusion. This study would represent the first meta-analysis investigating the safety of duloxetine in elderly population across all conditions approved by European and American regulatory authorities with an overall low risk of bias. Registration. PROSPERO: 2019 CRD42019130488.

scholarly journals Cytoreductive surgery (CRS) with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care (SoC) in people with peritoneal metastases from colorectal, ovarian or gastric origin: protocol for a systematic review and individual participant data (IPD) meta-analyses of effectiveness and cost-effectiveness

2020 ◽  
Author(s):  
Kurinchi Selvan Gurusamy ◽  
Claire Vale ◽  
Elena Pizzo ◽  
R Bhanot ◽  
Brian Davidson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Standard Of Care ◽  
Cost Utility ◽  
Peritoneal Metastases ◽  
Cost Utility Analysis ◽  
Individual Participant Data ◽  
Utility Analysis ◽  
Individual Participant

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.

scholarly journals Cytoreductive surgery (CRS) with hyperthermic intraoperative peritoneal chemotherapy (HIPEC) versus standard of care (SoC) in people with peritoneal metastases from colorectal, ovarian or gastric origin: protocol for a systematic review and individual participant data (IPD) meta-analyses of effectiveness and cost-effectiveness

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e039314
Author(s):  
Kurinchi Gurusamy ◽  
Claire L Vale ◽  
Elena Pizzo ◽  
R Bhanot ◽  
Brian R Davidson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Standard Of Care ◽  
Cost Utility ◽  
Peritoneal Metastases ◽  
Cost Utility Analysis ◽  
Individual Participant Data ◽  
Utility Analysis ◽  
Individual Participant

IntroductionThere is uncertainty about whether cytoreductive surgery (CRS)+hyperthermic intraoperative peritoneal chemotherapy (HIPEC) improves survival and/or quality of life compared with standard of care (SoC) in people with peritoneal metastases who can withstand major surgery.Primary objectivesTo 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 objectivesTo compare the cost-effectiveness of CRS+HIPEC versus SoC from a National Health Service (NHS) and personal social services perspective using a model-based cost–utility analysis.Methods and analysisWe 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 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 intervention and control, and outcome data related to overall survival, disease progression, health-related quality of life, treatment related complications and resource utilisation data. Using IPD, we will perform a two-step IPD, that is, calculate the adjusted effect estimate from each included study and then perform a random-effects model meta-analysis. We will perform various subgroup analyses, meta-regression and sensitivity analyses. We will also perform a model-based cost–utility analysis to assess whether CRS+HIPEC is cost-effective in the NHS setting.Ethics and disseminationThis project was approved by the UCL Research Ethics Committee (Ethics number: 16023/001). We aim to present the findings at appropriate international meetings and publish the review, irrespective of the findings, in a peer-reviewed journal.PROSPERO registration numberCRD42019130504.

scholarly journals Long working hours and alcohol use: systematic review and meta-analysis of published studies and unpublished individual participant data

BMJ ◽  
2015 ◽  
Vol 350 (jan12 13) ◽  
pp. g7772-g7772 ◽  
Author(s):  
M. Virtanen ◽  
M. Jokela ◽  
S. T. Nyberg ◽  
I. E. H. Madsen ◽  
T. Lallukka ◽  
...  
Keyword(s):  
Systematic Review ◽  
Alcohol Use ◽  
Meta Analysis ◽  
Working Hours ◽  
Individual Participant Data ◽  
Long Working Hours ◽  
Individual Participant

scholarly journals Effects of mechanical interventions in the management of knee osteoarthritis: protocol for an OA Trial Bank systematic review and individual participant data meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043026
Author(s):  
Erin M Macri ◽  
Michael Callaghan ◽  
Marienke van Middelkoop ◽  
Miriam Hattle ◽  
Sita M A Bierma-Zeinstra
Keyword(s):  
Systematic Review ◽  
Knee Osteoarthritis ◽  
Broad Class ◽  
Meta Analysis ◽  
Individual Participant Data ◽  
Knee Oa ◽  
International Regulations ◽  
Individual Participant ◽  
Registration Number ◽  
Mechanical Intervention

IntroductionKnee osteoarthritis (OA) is a prevalent and disabling musculoskeletal condition. Biomechanical factors may play a key role in the aetiology of knee OA, therefore, a broad class of interventions involves the application or wear of devices designed to mechanically support knees with OA. These include gait aids, bracing, taping, orthotics and footwear. The literature regarding efficacy of mechanical interventions has been conflicting or inconclusive, and this may be because certain subgroups with knee OA respond better to mechanical interventions. Our primary aim is to identify subgroups with knee OA who respond favourably to mechanical interventions.Methods and analysisWe will conduct a systematic review to identify randomised clinical trials of any mechanical intervention for the treatment of knee OA. We will invite lead authors of eligible studies to share individual participant data (IPD). We will perform an IPD meta-analysis for each type of mechanical intervention to evaluate efficacy, with our main outcome being pain. Where IPD are not available, this will be achieved using aggregate data. We will then evaluate five potential treatment effect modifiers using a two-stage approach. If data permit, we will also evaluate whether biomechanics mediate the effects of mechanical interventions on pain in knee OA.Ethics and disseminationNo new data will be collected in this study. We will adhere to institutional, national and international regulations regarding the secure and confidential sharing of IPD, addressing ethics as indicated. We will disseminate findings via international conferences, open-source publication in peer-reviewed journals and summaries posted on websites serving the public and clinicians.PROSPERO registration numberCRD42020155466.

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