Constructing a database of individual clinical trials for longitudinal analysis

Schmid, Christopher H.; Landa, Marcia; Jafar, Tazeen H.; Giatras, Ioannis; Karim, Tauqeer; Reddy, Manoj; Stark, Paul C.; Levey, Andrew S.

doi:10.1016/s0197-2456(02)00319-7

Cited by 20 publications

(12 citation statements)

References 29 publications

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“…Therefore, we did not require confirmation of the doublings for our analysis. Reasons for withdrawal were categorized as described previously [11,19]. [12] et al [13] et al a et al [14] et al [15] et al [5] et al [18] …”

Section: Discussionmentioning

confidence: 99%

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The effect of angiotensin-converting-enzyme inhibitors on progression of advanced polycystic kidney disease

Jafar

Stark

Schmid

et al. 2005

Kidney International

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As in other causes of non-diabetic kidney disease, antihypertensive regimens with ACE inhibitors are more effective in lowering urine protein excretion in patients with advanced PKD compared to regimens without ACE inhibitors, and this benefit is greater in patients with higher levels of baseline urine protein excretion. The effect of ACE inhibitors to slow kidney disease progression in PKD is inconclusive.

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Section: Discussionmentioning

confidence: 99%

“…The database contains blood pressure, urine protein excretion, serum creatinine, and onset of kidney failure during 22,610 visits. Inclusion and exclusion criteria, search strategies for identification of clinical trials, and details of database formulation have been described previously [11,19].…”

Section: Methodsmentioning

confidence: 99%

The effect of angiotensin-converting-enzyme inhibitors on progression of advanced polycystic kidney disease

Jafar

Stark

Schmid

et al. 2005

Kidney International

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“…Seven of the 53 articles (13.2%) described the methods used for statistical harmonization [54,59,71,73,83,84,98] (Table 1). Ten articles (18.9 %) focused on the conduct of IPD meta-analysis [2,3,60,64,70,76,90,92,99,100] and 6 articles (11.3%) focused on IPD meta-analysis methodology [8,18,57,74,77,79]. Six articles (11.3%) reviewed imputation methods and the appropriateness of their use [58,66,86,91,94,95] and 2 articles (3.8%) described methods for evaluating equivalence of item functioning across study subgroups [62,96].…”

Section: Resultsmentioning

confidence: 99%

Statistical approaches to harmonize data on cognitive measures in systematic reviews are rarely reported

Griffith

Heuvel

Fortier

et al. 2015

Journal of Clinical Epidemiology

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Objectives To identify statistical methods for harmonization which could be used in the context of summary data and individual participant data meta-analysis of cognitive measures. Study Design and Setting Environmental scan methods were used to conduct two reviews to identify: 1) studies that quantitatively combined data on cognition, and 2) general literature on statistical methods for data harmonization. Search results were rapidly screened to identify articles of relevance. Results All 33 meta-analyses combining cognition measures either restricted their analyses to a subset of studies using a common measure or combined standardized effect sizes across studies; none reported their harmonization steps prior to producing summary effects. In the second scan, three general classes of statistical harmonization models were identified: 1) standardization methods, 2) latent variable models, and 3) multiple imputation models; few publications compared methods. Conclusions Although it is an implicit part of conducting a meta-analysis or pooled analysis, the methods used to assess inferential equivalence of complex constructs are rarely reported or discussed. Progress in this area will be supported by guidelines for the conduct and reporting of the data harmonization and integration and by evaluating and developing statistical approaches to harmonization.

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“…Methods for pooling multiple independent studies have been previously described [18,19]. Steps include: 1) selection of participating clinical trials and databases; 2) development of a collaborative investigative team including clinicians, statisticians and programmers; 3) preliminary determination of the availability and characteristics of data in each of the component databases; 4) complete specification of the dependent (outcome) variable used in each study and in the pooled analyses; 5) determination and specification of the independent (explanatory) variables; 6) specification of the inclusion/exclusion criteria for the studies; 7) verification of variable definitions; 8) acquisition of new data if required; 9) checking for consistency of effects across study databases.…”

Section: Design/methodsmentioning

confidence: 99%

The Risk of Paradoxical Embolism (RoPE) Study: Developing risk models for application to ongoing randomized trials of percutaneous patent foramen ovale closure for cryptogenic stroke

Kent

Thaler

2011

Trials

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BackgroundDespite the diffusion into practice of percutaneous closure of a patent foramen ovale (PFO) in patients with cryptogenic stroke (CS), the benefits have not been demonstrated, and remain unclear. For any individual presenting with a PFO in the setting of CS, it is not clear whether the PFO is pathogenically-related to the index event or an incidental finding. Further, the overall rate of stroke recurrence is low in patients with CS and PFO. How patient-specific factors affect the likelihood that a discovered PFO is related to an index stroke or affect the risk of recurrence is not well understood. These probabilities are likely to be important determinants of the benefits of PFO closure in CS.Design/MethodsThe goal of the Risk of Paradoxical Embolism (RoPE) Study is to develop and test a set of predictive models that can identify those patients most likely to benefit from preventive treatments for PFO-related stroke recurrence, such as PFO closure. To do this, we will construct a database of patients with CS, both with and without PFO, by combining existing cohort studies. We will use this pooled database to identify patient characteristics associated with the presence (versus the absence) of a PFO, and to use this "PFO propensity" to estimate the patient-specific probability that a PFO was pathogenically related to the index stroke (Model #1). We will also develop, among patients with both a CS and a PFO, a predictive model to estimate patient-specific stroke recurrence risk based on clinical, radiographic and echocardiographic characteristics. (Model #2). We will then combine Models #1 and #2 into a composite index that can rank patients with CS and PFO by their conditional probability that their PFO was pathogenically related to the index stroke and the risk of stroke recurrence. Finally, we will apply this composite index to completed clinical trials (currently on-going) testing endovascular PFO closure against medical therapy, to stratify patients from low-expected-benefit to high-expected-benefit.

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Constructing a database of individual clinical trials for longitudinal analysis

Cited by 20 publications

References 29 publications

The effect of angiotensin-converting-enzyme inhibitors on progression of advanced polycystic kidney disease

The effect of angiotensin-converting-enzyme inhibitors on progression of advanced polycystic kidney disease

Statistical approaches to harmonize data on cognitive measures in systematic reviews are rarely reported

The Risk of Paradoxical Embolism (RoPE) Study: Developing risk models for application to ongoing randomized trials of percutaneous patent foramen ovale closure for cryptogenic stroke

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