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Development and Validation of a Novel Instrument for Assessing the Quality of Individual Patient Data Meta-Analysis

Date and Location




Saturday 21 September 2013 - 13:30 - 15:00


Presenting author and contact person

Presenting author

Francesco Chiappelli

Contact person

Francesco Chiappelli
Abstract text
Background: Sackett (1998) proposed that healthcare is a complex enterprise in practice and in theory. It is viewed as a scientific endeavor by some, and a service targeted to individuals in need by others. Patient-centered healthcare aims to improve the quality of healthcare by individualizing clinician-patient interactions. Patient-centered clinical approaches help clinicians interact with their patients across different social or cultural backgrounds, and national boundaries. Patient-centered care improves treatments effectiveness. Patient-centered outcomes research is central to evidence-based healthcare, which rests on the best available evidence obtained through research synthesis and meta-analysis. Evidence-based patient-centered outcomes research requires meta-analysis of individual patient data, in which the raw individual level data for each study are obtained and used for synthesis and analysis. Objectives: Several tools are available for evaluating the quality of systematic reviews, the relevance of the clinical consensus statements, and the overall stringency of the meta-analytical protocol (e.g., QUOROM, PRISMA). We developed a novel Tool to establish the quality of individual patient data meta-analysis, and subjected it to rigorous psychometric validation. Methods: We used content items of the QUOROM and the PRISMA to construct a 9-item instrument to assess the quality of individual patient data meta-analysis. We identified 3-5 sine-qua-non criteria for each item, and scored each item based on how many criteria were satisfied. Three readers, trained to use of the PRISMA and this new Tool, independently scored 13 independent patient data meta-analysis with the Tool and with the PRISMA. The sequence of the test used (Tool or PRISMA) was random for each paper across the readers. Results: We obtained construct, content and criterion validity (r=0.94, p<0.05), as well as coefficient of agreement and inter-rater reliability for the Tool (0.91, p<0.05). Conclusions: We present a novel, simple, valid and reliable instrument to quantify the quality of individual patient data meta-analysis.