No other ethical approvals were sought for this metaanalysis because all other included patientlevel datasets were depersonalised and publicly available. An individual patient data ipd metaanalysis offers several advantages for this purpose. The size of the analysis set and the number of events in the present analysis were slightly different from the reported literaturebased metaanalysis because of the availability of data. Aug 15, 2018 the clinical utility of serum procalcitonin levels in guiding antibiotic treatment decisions in patients with sepsis remains unclear. Request pdf moving from studylevel to patientlevel data. A comparison of summary patientlevel covariates in metaregression with individual patient data metaanalysis. Get real in individual participant data ipd metaanalysis.
We compared some regression analyses of ipd with metaregression analyses of the summarized data using a real. Cervical length screening for prevention of preterm birth in. Effect of treatment delay on the effectiveness and safety. Mortality not correlated with paclitaxel exposure jacc. Quality and completeness of the input data and the methods of analyses varied, and data heterogeneity was substantial. Factors affecting the electrocardiographic qt interval in. Pdf patientlevel data provide additional insight for. Metaanalysis of individual patient data from randomized trials. In their analysis, chatterjee et al 1 p3 instead chose to use unadjusted odds ratio ors to avoid bias from different types of adjustments in the various studies. Individual patient data metaanalysis of diagnostic studies. Comparison of effect estimates from a metaanalysis of summary data from.
We compared some regression analyses of ipd with metaregression analyses of the summarized data using a realworld example in order to investigate whether a. Angiotensinconverting enzyme inhibitors and progression of. Ethical or confidentiality concerns about using participant level data. In a patient level data meta analysis of 8 studies involving 445 ticagrelortreated patients, dm did not emerge as a factor predicting pr, although independently associated with lower probability. Six studies of low or moderate risk of bias with 957 patients were included. Jan 06, 2010 steinberg kk, smith sj, stroup df, et al.
Data analysis individuallevel rna sequencing data were downloaded for eligible studies and processed including correction of batch effects as outlined in appendix 1 p 3. An individual participant data ipd meta analysis can provide a unique insight into treatment effectiveness and the effect of individual level moderators on treatment outcome. Patient level vs group level data to adjust metaanalysis on transfusion and mortalityreply. This individual patientlevel data metaanalysis comprises data on 40 8 bleeding patients from two large trials in traumatic and postpartum bleeding. Individual patientparticipant data metaanalysis ktdrr. Pdf findings, phenotypes, and outcomes in freemansheldon. We identified trials performed between january 1, 1946 and july 5, 2018 prospero, number 42016052155. We compared some regression analyses of ipd with meta regression analyses of the summarized data using a realworld example in order to investigate whether a binary patient characteristic is related to treatment effect.
The principal findings of our individual patientlevel data metaanalysis are that most deaths from bleeding occur on the day of onset and many occur within the first few hours. Pdf cerclage for short cervix on ultrasound in singleton. Antidepressant drug effects and depression severity. However, it is known that study level analyses can lead to biased assessments and have some limitations in explaining the heterogeneity. May 10, 2016 a patient level data meta analysis of standardofcare treatments from eight prostate cancer clinical trials.
Individual patientversus grouplevel data metaregressions for the. From 7 available randomized controlled studies with patient level data, we. We found no evidence that the effectiveness and safety of tranexamic acid varied by site of bleeding but found strong evidence that treatment delay reduces the survival benefit. Since considerable manual effort needed to be invested in the processing of these data, only eight prostate cancer trials were downloaded and. Pdf a patientlevel data metaanalysis of standardof. Cumulative survival curves were created by the kaplanmeier method. Random effects trial intercept models were used to combine data from all trials in a 1stage individual patient data meta analysis.
A patientlevel data metaanalysis of standardofcare treatments from eight prostate cancer clinical trials. No other ethical approvals were sought for this meta analysis because all other included patient level datasets were depersonalised and publicly available. Our goal is to compare some regression analyses of ipd with meta regression analyses of the summarized data using a realworld example, in order to investigate whether a binary patient characteristic is related to treatment effect. Deaths from postpartum haemorrhage peak at 23 h after childbirth. When and how should i combine patientlevel data and literature data in a metaanalysis. Patient data from the coalition against major diseases. The outcomes assessed were deathreinfarction at 30 days and at 1 year, as well as deathreinfarctionrecurrent ischaemia, major bleeding and stroke at 30 days. Patients with symptomatic heart failure and left ventricular ejection fraction, 35%. The effect of antilymphocyte induction therapy on renal. Effects of intravascular ultrasoundguided versus angiography. The summary level meta analysis of published and presented data from heterogeneous studies of a variety of devices faced several disadvantages not experienced in the present study. Concise whole blood transcriptional signatures for. This patient level meta analysis based on 11 randomized trials investigates the impact of procalcitoninguided antibiotic therapy on mortality in intensive care unit icu patients with infection, both overall and stratified according to sepsis definition. The median age was 52 years interquartile range, 3566 y, 51.
Individual patient data metaanalysis of mathematical institute. Findings, phenotypes, and outcomes in freemansheldon and. Effect of treatment delay on the effectiveness and safety of. Investigating the stratified efficacy and safety of. Knowledge of independent, baseline risk factors for catheterrelated thrombosis crt may help select adult cancer patients who are at high risk to receive thromboprophylaxis.
An individual patient data ipd meta analysis offers several advantages for this purpose. Combining patientlevel and summarylevel data for alzheimer. Comparison of effect estimates from a metaanalysis of summary data from published studies and from a metaanalysis using individual patient data for ovarian cancer studies. A pooled analysis of individual patient data from 11 randomized, controlled trials using a type of blood pressure medicine, angiotensinconverting enzyme inhibitors, to prevent worsening of kidney disease unrelated to diabetes. An alternative but increasingly popular approach is metaanalysis of individual participant data, or individual patient data, in which the raw individual level data for each study are obtained and used for synthesis. This individual patient level data metaanalysis comprises data on 40 8 bleeding patients from two large trials in traumatic and postpartum bleeding.
Rather than depending on summary statistics calculated for. Pdf integrating aggregatedata and individualpatientdata in. Risk factors for catheterrelated thrombosis crt in cancer. Although our trial level data support prevous findings, patient level data did not show any significant effect of initial depression severity on drug v. Pdf open clinical trial data offer many opportunities for the scientific community to independently verify published results, evaluate new hypotheses. The patient data were collected from 10 randomized trials from the metaanalysis reported by sakamoto et al. A patient level data metaanalysis of standardofcare treatments from eight prostate cancer clinical trials. Comparison of effect estimates from a meta analysis of summary data from published studies and from a meta analysis using individual patient data for ovarian cancer studies. The most common treatment resulting in exceptional response was a form of chemotherapy 49.
Glass, 1976 modelbased metaanalysis has taken on an important role in drug development decision making lalonde et al. Although ipd is a potential gold mine in biomedical areas, methodological development has been slow owing to limited access to such data. Metaanalysis of the literature or of individual patient data. Jonathan l french, scd patanjali ravva, ms page 2010, berlin 10 june 2010. Initial depression severity and response to antidepressants v. We retested this using patient level data and also undertaking a meta analysis of trial level data from 34 randomised placebo controlled trials n 10 737 from the newmeds registry. Effect of tranexamic acid by baseline risk of death in acute. Effect of procalcitoninguided antibiotic treatment on. Pdf on sep 12, 2012, paul c mcgovern and others published patientlevel data provide additional insight for tigecycline allcause mortality metaanalysis find, read and cite all the research. Updating insights into rosiglitazone and cardiovascular risk. Once digitised, individual patient level data sets were converted into a standard file format using stattransfer version. Implantable cardioverterdefibrillators for primary. Most deaths from haemorrhage occur within hours of bleeding onset.
Individual participant data metaanalysis cochrane skin. Risk factors for catheterrelated thrombosis crt in. Metaanalysis is one of the key pillars of modelbased drug development the statistical analysis of a large collection of data from individual studies for the purpose of integrating the findings. When and how should i combine patient level data and. Saccone division of maternalfetal medicine, department of obstetrics and gynecology, sidney kimmel medical college of thomas jefferson. Cervical length screening by transvaginal sonography tvs has been shown to be a good predictive test for spontaneous preterm birth ptb in symptomatic singleton pregnancy with threatened preterm labor ptl. An individual patient data ipd metaanalysis offers several. Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after. Individual patientlevel and studylevel metaanalysis for. Effect of tranexamic acid by baseline risk of death in. Metaanalyses ma based on individual patient data ipd are.
When patient level data are not available, confounding in metaanalysis can be minimized by using adjusted odds andor hazard ratios from each source study. A patientlevel data metaanalysis of standardofcare. Tranexamic acid improves survival but treatment delay reduces the benefit. Gonadotropinreleasing hormone agonists during chemotherapy. For studies of repeated treatments, only data from the first treatment episode were extracted. Predicting tuberculosis relapse in patients treated. When conducting the meta analysis of rcts for which we have obtained data at individual patient level, we will report quality assessment of these rcts based on randomisation procedures, treatment allocations according to assignment, and outcomes collected and compared across comparison groups. An alternative but increasingly popular approach is meta analysis of individual participant data, or individual patient data, in which the raw individual level data for each study are obtained and used for synthesis. Neither project data sphere, llc nor the owners of any information from the web site have contributed to, approved or are in any way responsible for the contents of this publication. Consistency of benefit from an early invasive strategy after.
Individual patient network metaanalysis from the inception of the studylevel metaanalyses. Concise whole blood transcriptional signatures for incipient. The size of the analysis set and the number of events in the present analysis were slightly different from the reported literaturebased metaanalysis because of the availability of data and timing of the analysis. A patientlevel data metaanalysis of standardofcare treatments. We performed an individual patient level data meta analysis of randomised trials including more than patients that assessed antifibrinolytics in acute severe bleeding.
However, it is known that studylevel analyses can lead to biased assessments and have some limitations in explaining the heterogeneity. Platelet reactivity during ticagrelor maintenance therapy. Jul 17, 2001 the effect of angiotensinconverting enzyme inhibitors on the progression of nondiabetic renal disease. The effect of antilymphocyte induction therapy on renal allograft survival. Given the individual patient level data available, both twostage and onestage meta analysis were conducted. When the effect of the covariate at the ad level is different from that at the ipd level we are prone to aggregation aka ecological bias this has been recognized as a problem for a long time in the ecological regression field wakefield 2008 and more recently in metaanalysis berlin et al. Patients with lbbb were divided into groups defined by 10millisecond qrs duration intervals. Meta analysis of patient level data from randomized controlled trials. For twostage meta analysis, the primary outcomes were dichotomized as unfavorable and favorable outcome, and all secondary outcomes were binary outcomes. Effects of norepinephrine and vasopressin discontinuation. The aim of this study was to evaluate the clinical usefulness of intravascular ultrasound ivusguided newgeneration drugeluting stent des implantation using a metaanalysis of individual patientlevel data from randomized trials. Patientlevel vs grouplevel data to adjust metaanalysis. We performed an individual patientlevel data metaanalysis of randomised trials including more than patients that assessed antifibrinolytics in acute severe bleeding. Jul 21, 2012 our objective was to develop a beta regression br model to describe the longitudinal progression of the 11 item alzheimers disease ad assessment scale cognitive subscale adascog in ad patients in both natural history and randomized clinical trial settings, utilizing both individual patient and summary level literature data.
746 127 620 314 1487 205 46 1484 657 1149 933 1254 19 875 637 903 614 2 776 920 1619 978 1586 1639 831 796 669 403 1402 58 225 445 1218 691 252 708 268 337 94 1455 769 966 477 1490