Abstract
BackgroundClinical registries, which capture information about the health and healthcare use of patients with a health condition or treatment, often contain patient-reported outcomes (PROs) that provide insights about the patient’s perspectives on their health. Missing data can affect the value of PRO data for healthcare decision-making. We compared the precision and bias of several missing data methods when estimating longitudinal change in PRO scores.MethodsThis research conducted analyses of clinical registry data and simulated data. Registry data were from a population-based regional joint replacement registry for Manitoba, Canada; the study cohort consisted of 5631 patients having total knee arthroplasty between 2009 and 2015. PROs were measured using the 12-item Short Form Survey, version 2 (SF-12v2) at pre- and post-operative occasions. The simulation cohort was a subset of 3000 patients from the study cohort with complete PRO information at both pre- and post-operative occasions. Linear mixed-effects models based on complete case analysis (CCA), maximum likelihood (ML) and multiple imputation (MI) without and with an auxiliary variable (MI-Aux) were used to estimate longitudinal change in PRO scores. In the simulated data, bias, root mean squared error (RMSE), and 95% confidence interval (CI) coverage and width were estimated under varying amounts and types of missing data.ResultsThree thousand two hundred thirty (57.4%) patients in the study cohort had complete data on the SF-12v2 at both occasions. In this cohort, mixed-effects models based on CCA resulted in substantially wider 95% CIs than models based on ML and MI methods. The latter two methods produced similar estimates and 95% CI widths. In the simulation cohort, when 50% of the data were missing, the MI-Aux method, in which a single hypothetical auxiliary variable was strongly correlated (i.e., 0.8) with the outcome, reduced the 95% CI width by up to 14% and bias and RMSE by up to 50 and 45%, respectively, when compared with the MI method.ConclusionsMissing data can substantially affect the precision of estimated change in PRO scores from clinical registry data. Inclusion of auxiliary information in MI models can increase precision and reduce bias, but identifying the optimal auxiliary variable(s) may be challenging.
Highlights
Clinical registries, which capture information about the health and healthcare use of patients with a health condition or treatment, often contain patient-reported outcomes (PROs) that provide insights about the patient’s perspectives on their health
PRO data in registries can be a useful tool for clinicians to assess quality of care and improvements in patient health status, beyond what can be captured from objective measures of health status such as complication rates and patient mortality [2]
The Registry captures more than 90% of all hip and knee replacement surgeries performed within the health region and approximately 75% of all replacement surgeries conducted in the province
Summary
Clinical registries, which capture information about the health and healthcare use of patients with a health condition or treatment, often contain patient-reported outcomes (PROs) that provide insights about the patient’s perspectives on their health. Clinical registries are databases that capture information about the health and healthcare use of patients having a specific health condition or healthcare treatment. Patientreported outcomes (PROs) are increasingly collected in clinical registries because they provide valuable information about the patient’s perspectives on their health, including pain, perceived functional abilities, and mental health [1]. Clinical registry data have a number of other potential uses, including evaluations of new programs and treatments. Clinical registry data collection and evaluation may not always follow the same methods or practices as are used in research studies involving primary data collection [3]. Clinics may not have the resources needed to routinely and thoroughly check the data for accuracy and completeness
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