Patient-reported outcomes in meta-analyses -Part 2: methods for improving interpretability for decision-makers
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Patient-reported outcomes in meta-analyses – Part 2: methods for improving interpretability for decision-makers Bradley C Johnston1,2*, Donald L Patrick3,4, Kristian Thorlund5, Jason W Busse5,6,9, Bruno R da Costa7, Holger J Schünemann5,8 and Gordon H Guyatt5,8
Abstract Systematic reviews and meta-analyses of randomized trials that include patient-reported outcomes (PROs) often provide crucial information for patients, clinicians and policy-makers facing challenging health care decisions. Based on emerging methods, guidance on improving the interpretability of meta-analysis of patient-reported outcomes, typically continuous in nature, is likely to enhance decision-making. The objective of this paper is to summarize approaches to enhancing the interpretability of pooled estimates of PROs in meta-analyses. When differences in PROs between groups are statistically significant, decision-makers must be able to interpret the magnitude of effect. This is challenging when, as is often the case, clinical trial investigators use different measurement instruments for the same construct within and between individual randomized trials. For such cases, in addition to pooling results as a standardized mean difference, we recommend that systematic review authors use other methods to present results such as relative (relative risk, odds ratio) or absolute (risk difference) dichotomized treatment effects, complimented by presentation in either: natural units (e.g. overall depression reduced by 2.4 points when measured on a 50-point Hamilton Rating Scale for Depression); minimal important difference units (e.g. where 1.0 unit represents the smallest difference in depression that patients, on average, perceive as important the depression score was 0.38 (95% CI 0.30 to 0.47) units less than the control group); or a ratio of means (e.g. where the mean in the treatment group is divided by the mean in the control group, the ratio of means is 1.27, representing a 27% relative reduction in the mean depression score).
Introduction Clinical trials evaluating medical treatments and health interventions increasingly incorporate self-reported measures from patients, often referred to as patient-reported outcomes (PROs). A PRO is defined as “any report of the status of a patient’s health condition that comes directly from the patient without interpretation of the patient’s response by a clinician or anyone else” [1]. Systematic reviews and meta-analyses of clinical trials often include PROs. In Part 1 of this series, we addressed the importance of PROs for health care decision-making, illustrated the key risk of bias issues that systematic reviews of PROs * Correspondence: [email protected] 1 Department of Anesthesia and Pain Medicine, and Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, Canada 2 Child Health Evaluative Sciences, Hospital for Sick Children Research Institute, Toronto, ON, Canada Full list of author information is available at the end of the article
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