scholarly journals Systematic review and network meta-analysis with individual participant data on Cord Management at Preterm Birth (iCOMP): study protocol

2019 ◽  
Author(s):  
Anna Lene Seidler ◽  
Lelia Duley ◽  
Anup Katheria ◽  
Catalina De Paco Matallana ◽  
Eugene Dempsey ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Preterm Infants ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Management Strategies ◽  
Individual Participant Data ◽  
Cord Clamping ◽  
Individual Participant ◽  
Participant Characteristics ◽  
Meta Analyses

ABSTRACTIntroductionTiming of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups such as those who usually receive immediate neonatal care. Previous and current trials compare various policies, including immediate cord clamping, time- or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enables exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons.Objectives1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis; and 2) to evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA.Methods and analysisWe will conduct a systematic search of Medline, Embase, clinical trial registries, and other sources for all planned, ongoing and completed randomised controlled trials comparing alternative cord management strategies at preterm birth (before 37 weeks’ gestation). IPD will be sought for all trials. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for pre-specified subgroups of participants. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes intraventricular haemorrhage (any grade) and infant blood transfusions (any). Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored.Ethics and disseminationApproved by University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline-developers and policy-makers, and will be disseminated via publications, presentations, and media releases.RegistrationAustralian New Zealand Clinical Trials Registry: ACTRN12619001305112.STRENGTH AND LIMITATIONS OF THIS STUDYThis will be the most comprehensive review to date of interventions for umbilical cord management in preterm infants and the findings will be highly relevant to clinicians and guideline developersThe use of individual participant data will allow assessment of the best treatment option for key subgroups of participantsNetwork meta-analysis will enable the comparison and ranking of all available treatment options using direct and indirect evidenceFor some of the trials it will not be possible to obtain individual participant data, so published aggregate results will be used insteadRisk of bias in the primary trials will be assessed using Cochrane criteria, and certainty of evidence for the meta-analyses will be appraised using the GRADE approach for the pairwise comparisons, and the CINeMA approach for the network meta-analysis

scholarly journals Systematic review and network meta-analysis with individual participant data on cord management at preterm birth (iCOMP): study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e034595
Author(s):  
Anna Lene Seidler ◽  
Lelia Duley ◽  
Anup C Katheria ◽  
Catalina De Paco Matallana ◽  
Eugene Dempsey ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Management Strategies ◽  
Preterm Births ◽  
Individual Participant Data ◽  
Mortality And Morbidity ◽  
Cord Clamping ◽  
Individual Participant ◽  
Participant Characteristics

IntroductionTiming of cord clamping and other cord management strategies may improve outcomes at preterm birth. However, it is unclear whether benefits apply to all preterm subgroups. Previous and current trials compare various policies, including time-based or physiology-based deferred cord clamping, and cord milking. Individual participant data (IPD) enable exploration of different strategies within subgroups. Network meta-analysis (NMA) enables comparison and ranking of all available interventions using a combination of direct and indirect comparisons.Objectives(1) To evaluate the effectiveness of cord management strategies for preterm infants on neonatal mortality and morbidity overall and for different participant characteristics using IPD meta-analysis. (2) To evaluate and rank the effect of different cord management strategies for preterm births on mortality and other key outcomes using NMA.Methods and analysisSystematic searches of Medline, Embase, clinical trial registries, and other sources for all ongoing and completed randomised controlled trials comparing cord management strategies at preterm birth (before 37 weeks’ gestation) have been completed up to 13 February 2019, but will be updated regularly to include additional trials. IPD will be sought for all trials; aggregate summary data will be included where IPD are unavailable. First, deferred clamping and cord milking will be compared with immediate clamping in pairwise IPD meta-analyses. The primary outcome will be death prior to hospital discharge. Effect differences will be explored for prespecified participant subgroups. Second, all identified cord management strategies will be compared and ranked in an IPD NMA for the primary outcome and the key secondary outcomes. Treatment effect differences by participant characteristics will be identified. Inconsistency and heterogeneity will be explored.Ethics and disseminationEthics approval for this project has been granted by the University of Sydney Human Research Ethics Committee (2018/886). Results will be relevant to clinicians, guideline developers and policy-makers, and will be disseminated via publications, presentations and media releases.Registration numberAustralian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN12619001305112) and International Prospective Register of Systematic Reviews (PROSPERO, CRD42019136640).

scholarly journals Arm Based on LEg blood pressures (ABLE-BP): can systolic leg blood pressure measurements predict systolic brachial blood pressure? Protocol for an individual participant data meta-analysis from the INTERPRESS-IPD Collaboration

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e040481
Author(s):  
Sinead T J McDonagh ◽  
James P Sheppard ◽  
Fiona C Warren ◽  
Kate Boddy ◽  
Leon Farmer ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Prognostic Models ◽  
Individual Participant Data ◽  
Dissemination Strategy ◽  
Cross Sectional ◽  
Individual Participant ◽  
Meta Analyses

IntroductionBlood pressure (BP) is normally measured on the upper arm, and guidelines for the diagnosis and treatment of high BP are based on such measurements. Leg BP measurement can be an alternative when brachial BP measurement is impractical, due to injury or disability. Limited data exist to guide interpretation of leg BP values for hypertension management; study-level systematic review findings suggest that systolic BP (SBP) is 17 mm Hg higher in the leg than the arm. However, uncertainty remains about the applicability of this figure in clinical practice due to substantial heterogeneity.AimsTo examine the relationship between arm and leg SBP, develop and validate a multivariable model predicting arm SBP from leg SBP and investigate the prognostic association between leg SBP and cardiovascular disease and mortality.Methods and analysisIndividual participant data (IPD) meta-analyses using arm and leg SBP measurements for 33 710 individuals from 14 studies within the Inter-arm blood pressure difference IPD (INTERPRESS-IPD) Collaboration. We will explore cross-sectional relationships between arm and leg SBP using hierarchical linear regression with participants nested by study, in multivariable models. Prognostic models will be derived for all-cause and cardiovascular mortality and cardiovascular events.Ethics and disseminationData originate from studies with prior ethical approval and consent, and data sharing agreements are in place—no further approvals are required to undertake the secondary analyses proposed in this protocol. Findings will be published in peer-reviewed journal articles and presented at conferences. A comprehensive dissemination strategy is in place, integrated with patient and public involvement.PROSPERO registration numberCRD42015031227.

scholarly journals An individual participant data (IPD) meta-analysis on the attachment network to multiple caregivers

2020 ◽  
Author(s):  
Or Dagan ◽  
Pasco Fearon ◽  
Carlo Schuengel ◽  
Marije Verhage ◽  
Glenn I. Roisman ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Developmental Outcomes ◽  
Research Synthesis ◽  
Individual Participant Data ◽  
Attachment Relationship ◽  
Attachment Research ◽  
Individual Participant ◽  
The Subject ◽  
Meta Analyses

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.

scholarly journals Retrieval of Individual Participant Data for Exercise Meta-Analyses May Not Be Worth the Time and Effort

2016 ◽  
Vol 2016 ◽  
pp. 1-5 ◽  
Author(s):  
George A. Kelley ◽  
Kristi S. Kelley
Keyword(s):  
Logistic Regression ◽  
Rheumatic Diseases ◽  
Gold Standard ◽  
Odds Ratio ◽  
Meta Analysis ◽  
Individual Participant Data ◽  
Individual Participant ◽  
Using Data ◽  
Meta Analyses

Purpose. While individual participant data (IPD) meta-analyses are considered the gold standard for meta-analysis, the feasibility of obtaining IPD may be problematic.Methods. Using data from a previous meta-analysis of 29 studies on exercise in adults with arthritis and other rheumatic diseases, the percentage of studies in which useable IPD was provided was calculated.Results. Eight of 29 authors (28%, 95% CI = 11% to 44%) provided IPD. Using logistic regression, neither year of publication (odds ratio = 1.05, 95% CI = 0.90 to 1.27,p=0.58) nor country (odds ratio = 1.36, 95% CI = 0.20 to 10.9,p=1.00) was significantly associated with the obtainment of IPD.Conclusions. The retrieval of IPD for exercise meta-analyses may not be worth the time and effort. However, further research is needed before any final recommendations can be made.

scholarly journals Protocol for individual participant data meta-analysis of randomised controlled trials of patients with psychosis to investigate treatment effect modifiers for CBT versus treatment as usual or other psychosocial interventions

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e035062
Author(s):  
Maria Sudell ◽  
Catrin Tudur-Smith ◽  
Xiaomeng Liao ◽  
Eleanor Longden ◽  
Graham Dunn ◽  
...  
Keyword(s):  
Treatment Effect ◽  
Meta Analysis ◽  
Psychosocial Interventions ◽  
Controlled Trials ◽  
Individual Participant Data ◽  
Potential Treatment ◽  
Treatment As Usual ◽  
Schizophrenia Spectrum ◽  
Individual Participant ◽  
Meta Analyses

IntroductionAggregate data meta-analyses have shown heterogeneous treatment effects for cognitive–behavioural therapy (CBT) for patients with schizophrenia spectrum diagnoses. This heterogeneity could stem from specific intervention or patient characteristics that could influence the clinical effectiveness of CBT, termed treatment effect modifiers. This individual participant data meta-analysis will investigate a range of potential treatment effect modifiers of the efficacy of CBT.Methods and analysisWe will perform a systematic review and meta-analysis of studies investigating CBT versus treatment as usual, or CBT versus other psychosocial interventions, for patients with schizophrenia spectrum diagnoses. The Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, EMBASE and the online clinical trials registers of the US government, European Union, WHO and Current Controlled Trials will be searched. Two researchers will screen titles and abstracts identified by the search. Individual participant data will be requested for any eligible study, for the primary outcome (overall psychotic symptoms), secondary outcomes and treatment effect modifiers. Data will be checked and recoded according to an established statistical analysis plan. One-stage and two-stage random effects meta-analyses investigating potential treatment effect modifiers will be conducted. A list of potential treatment effect modifiers for CBT will be produced, motivating future research into particular modifiers.Ethics and disseminationThis study does not require ethical approval as it is based on data from existing studies, although best ethical practice for secondary analysis of clinical data will be followed. The findings will be submitted for publication in peer-reviewed journals, and promoted to relevant stakeholders.PROSPERO registration numberCRD42017060068.

scholarly journals The efficacy of antidepressant medication and interpersonal psychotherapy for adult acute-phase depression: study protocol of a systematic review and meta-analysis of individual participant data

BJPsych Open ◽  
2021 ◽  
Vol 7 (2) ◽  
Author(s):  
Ellen Driessen ◽  
Zachary D. Cohen ◽  
Myrna M. Weissman ◽  
John C. Markowitz ◽  
Erica S. Weitz ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Acute Phase ◽  
Meta Analysis ◽  
Antidepressant Medication ◽  
Depression Treatment ◽  
Individual Participant Data ◽  
Individual Participant ◽  
Meta Analyses

Background Antidepressant medication and interpersonal psychotherapy (IPT) are both recommended interventions in depression treatment guidelines based on literature reviews and meta-analyses. However, ‘conventional’ meta-analyses comparing their efficacy are limited by their reliance on reported study-level information and a narrow focus on depression outcome measures assessed at treatment completion. Individual participant data (IPD) meta-analysis, considered the gold standard in evidence synthesis, can improve the quality of the analyses when compared with conventional meta-analysis. Aims We describe the protocol for a systematic review and IPD meta-analysis comparing the efficacy of antidepressants and IPT for adult acute-phase depression across a range of outcome measures, including depressive symptom severity as well as functioning and well-being, at both post-treatment and follow-up (PROSPERO: CRD42020219891). Method We will conduct a systematic literature search in PubMed, PsycINFO, Embase and the Cochrane Library to identify randomised clinical trials comparing antidepressants and IPT in the acute-phase treatment of adults with depression. We will invite the authors of these studies to share the participant-level data of their trials. One-stage IPD meta-analyses will be conducted using mixed-effects models to assess treatment effects at post-treatment and follow-up for all outcome measures that are assessed in at least two studies. Conclusions This will be the first IPD meta-analysis examining antidepressants versus IPT efficacy. This study has the potential to enhance our knowledge of depression treatment by comparing the short- and long-term effects of two widely used interventions across a range of outcome measures using state-of-the-art statistical techniques.

scholarly journals Induction of labour at 41 weeks or expectant management until 42 weeks: A systematic review and an individual participant data meta-analysis of randomised trials

PLoS Medicine ◽  
2020 ◽  
Vol 17 (12) ◽  
pp. e1003436
Author(s):  
Mårten Alkmark ◽  
Judit K. J. Keulen ◽  
Joep C. Kortekaas ◽  
Christina Bergh ◽  
Jeroen van Dillen ◽  
...  
Keyword(s):  
Perinatal Outcome ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Perinatal Outcomes ◽  
Expectant Management ◽  
Neonatal Morbidity ◽  
Individual Participant Data ◽  
Nulliparous Women ◽  
Multiparous Women ◽  
Individual Participant

Background The risk of perinatal death and severe neonatal morbidity increases gradually after 41 weeks of pregnancy. Several randomised controlled trials (RCTs) have assessed if induction of labour (IOL) in uncomplicated pregnancies at 41 weeks will improve perinatal outcomes. We performed an individual participant data meta-analysis (IPD-MA) on this subject. Methods and findings We searched PubMed, Excerpta Medica dataBASE (Embase), The Cochrane Library, Cumulative Index of Nursing and Allied Health Literature (CINAHL), and PsycINFO on February 21, 2020 for RCTs comparing IOL at 41 weeks with expectant management until 42 weeks in women with uncomplicated pregnancies. Individual participant data (IPD) were sought from eligible RCTs. Primary outcome was a composite of severe adverse perinatal outcomes: mortality and severe neonatal morbidity. Additional outcomes included neonatal admission, mode of delivery, perineal lacerations, and postpartum haemorrhage. Prespecified subgroup analyses were conducted for parity (nulliparous/multiparous), maternal age (<35/≥35 years), and body mass index (BMI) (<30/≥30). Aggregate data meta-analysis (MA) was performed to include data from RCTs for which IPD was not available. From 89 full-text articles, we identified three eligible RCTs (n = 5,161), and two contributed with IPD (n = 4,561). Baseline characteristics were similar between the groups regarding age, parity, BMI, and higher level of education. IOL resulted overall in a decrease of severe adverse perinatal outcome (0.4% [10/2,281] versus 1.0% [23/2,280]; relative risk [RR] 0.43 [95% confidence interval [CI] 0.21 to 0.91], p-value 0.027, risk difference [RD] −57/10,000 [95% CI −106/10,000 to −8/10,000], I2 0%). The number needed to treat (NNT) was 175 (95% CI 94 to 1,267). Perinatal deaths occurred in one (<0.1%) versus eight (0.4%) pregnancies (Peto odds ratio [OR] 0.21 [95% CI 0.06 to 0.78], p-value 0.019, RD −31/10,000, [95% CI −56/10,000 to −5/10,000], I2 0%, NNT 326, [95% CI 177 to 2,014]) and admission to a neonatal care unit ≥4 days occurred in 1.1% (24/2,280) versus 1.9% (46/2,273), (RR 0.52 [95% CI 0.32 to 0.85], p-value 0.009, RD −97/10,000 [95% CI −169/10,000 to −26/10,000], I2 0%, NNT 103 [95% CI 59 to 385]). There was no difference in the rate of cesarean delivery (10.5% versus 10.7%; RR 0.98, [95% CI 0.83 to 1.16], p-value 0.81) nor in other important perinatal, delivery, and maternal outcomes. MA on aggregate data showed similar results. Prespecified subgroup analyses for the primary outcome showed a significant difference in the treatment effect (p = 0.01 for interaction) for parity, but not for maternal age or BMI. The risk of severe adverse perinatal outcome was decreased for nulliparous women in the IOL group (0.3% [4/1,219] versus 1.6% [20/1,264]; RR 0.20 [95% CI 0.07 to 0.60], p-value 0.004, RD −127/10,000, [95% CI −204/10,000 to −50/10,000], I2 0%, NNT 79 [95% CI 49 to 201]) but not for multiparous women (0.6% [6/1,219] versus 0.3% [3/1,264]; RR 1.59 [95% CI 0.15 to 17.30], p-value 0.35, RD 27/10,000, [95% CI −29/10,000 to 84/10,000], I2 55%). A limitation of this IPD-MA was the risk of overestimation of the effect on perinatal mortality due to early stopping of the largest included trial for safety reasons after the advice of the Data and Safety Monitoring Board. Furthermore, only two RCTs were eligible for the IPD-MA; thus, the possibility to assess severe adverse neonatal outcomes with few events was limited. Conclusions In this study, we found that, overall, IOL at 41 weeks improved perinatal outcome compared with expectant management until 42 weeks without increasing the cesarean delivery rate. This benefit is shown only in nulliparous women, whereas for multiparous women, the incidence of mortality and morbidity was too low to demonstrate any effect. The magnitude of risk reduction of perinatal mortality remains uncertain. Women with pregnancies approaching 41 weeks should be informed on the risk differences according to parity so that they are able to make an informed choice for IOL at 41 weeks or expectant management until 42 weeks. Study Registration: PROSPERO CRD42020163174

scholarly journals Compliance With Preferred Reporting Items for Systematic Review and Meta-Analysis Individual Participant Data Statement for Meta-Analyses Published for Stroke Studies

Stroke ◽  
2021 ◽  
Author(s):  
Fareed Jumah ◽  
Silky Chotai ◽  
Omar Ashraf ◽  
Michael S. Rallo ◽  
Bharath Raju ◽  
...  
Keyword(s):  
Systematic Review ◽  
Impact Factor ◽  
Evidence Synthesis ◽  
Meta Analysis ◽  
Interquartile Range ◽  
Individual Participant Data ◽  
Related Factors ◽  
Scoping Reviews ◽  
Individual Participant ◽  
Meta Analyses

Background and Purpose: Individual-participant data meta-analyses (IPD-MA) are powerful evidence synthesis studies which are considered the gold-standard of MA. The quality of reporting in these studies is guided by the 2015 Preferred Reporting Items for Systematic Review and Meta-Analysis of Individual Participant Data (PRISMA-IPD) guidelines. The growing number of IPD-MA published for stroke studies calls for an assessment of the compliance of these studies with the PRISMA-IPD statement. Methods: PubMed and EMBASE were searched for MA in stroke published between January 1, 2016, and March 30, 2020, in journals with impact factor >2. Literature reviews, scoping reviews, and aggregate MA were excluded. The final articles were scored using the 31-item PRISMA-IPD checklist. Results were depicted using descriptive statistics. Compliance with each item in PRISM-IPD guideline was recorded. The study was defined as compliant to IPD analyses if it satisfied all IPD specific items. Results: From an initial set of 321 articles, 31 met the final eligibility for data extraction. Only 4 (13%) described the use of PRISMA-IPD guidelines in their methodology, while 8/31 (26%) used the old PRISMA guidelines and 19/31 (61%) followed none. Regardless of mention of using IPD specific guidelines, 42% (n=13) of studies were compliant with all 4 IPD specific domains. The poorest areas of compliance were bias assessment within (32%) and across (39%) studies, reporting protocol and registration (42%), and reporting of IPD integrity (48%). The median journal impact factor was similar between the compliant (median, 8.1 [interquartile range, 5.4–39.9]) and noncompliant (median, 6 [interquartile range, 4.5–16.2]) groups ( P =0.24). Similarly, the journal, country of correspondence, number of authors, number of studies included in MA, study sample size, and funding source were statistically similar between the groups. Conclusions: For the published IPD-MA stroke studies, the compliance with PRISMA-IPD statement and compliance with 4 IPD specific items was suboptimal. The journal, author, and study-related factors were not associated with compliance. Additional scrutiny measures to ensure adherence to mandated guidelines might increase the compliance. Several avenues to improve compliance and ensure optimal adherence are discussed.

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