Use of patient-reported outcomes in the context of different levels of data

Journal Journal of Bone and Joint Surgery, American Volume
Authors Rolfson, Ola; Rothwell, Alastair; Sedrakyan, Art; Chenok, Kate Eresian; Bohm, Eric; Bozic, Kevin; Garellick, Göran
Year Published 2011
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Abstract

There is increasing interest in measuring patient-reported outcomes as part of routine medical practice, particularly in fields like total joint replacement surgery, where pain relief, satisfaction, function, and health-related quality of life, as perceived by the patient, are primary outcomes. We review some well-known outcome instruments, measurement issues, and early experiences with large-scale collection of patient-reported outcome measures in joint registries. The patient-reported outcome measures are reviewed in the context of multidimensional outcome assessment that includes the traditional clinical outcome parameters as well as disease-specific and general patient-reported outcome measures.

Review of clinical outcomes-based anchors of minimum clinically important differences in hip and knee registry-based reports and publications

Journal Journal of Bone and Joint Surgery, American Volume
Authors Romero, Lucas; Nieuwenhuijse, Marc; Carr, Andrew; Sedrakyan, Art
Year Published 2014
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Abstract

Patient-reported outcome measures are tools that allow clinicians and researchers to gauge patients’ level of satisfaction and quality of life after a medical intervention. The use of patient-reported outcome measures and the clinically relevant score differentials over time as they relate to outcomes (minimum clinically important differences) has been proposed as a way to understand success and failure rates in orthopaedics. We conducted a systematic appraisal of literature in peer-reviewed journals and registry reports to measure the use that registries and other large data repositories make of minimum clinically important differences and to understand methodological approaches for such uses. Of the nineteen registry reports and 1052 articles examined, we found that only one report and two studies mentioned the use of patient-reported outcome measures and minimum clinically important differences in the context of revision rates of total knee arthroplasty and total hip arthroplasty. We conclude that although the infrastructure and efforts to routinely collect patient-reported outcome measures at registry levels do exist, there is limited use of minimum clinically important differences to understand and potentially predict clinical outcomes. We suggest advancing the global infrastructure such as the International Consortium of Orthopaedic Registries to address how research related to patient-reported outcome measures can help individual registries collaborate in the development of tools and allow aggregation of data.

Beyond joint implant registries: a patient-centered research consortium for comparative effectiveness in total joint replacement.

Journal JAMA
Authors Franklin, Patricia; Allison, Jeroan; Ayers, David
Year Published  2012
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Introduction

Despite the proven effectiveness of total joint replacement (TJR) surgery in relieving advanced knee and hip arthritis pain, TJR outcomes have come under intense public scrutiny in recent years. The 2010 recall of ASR metal-on-metal hip implants1 heightened awareness of the importance for implant safety surveillance for this high-cost and high-use procedure and exposed the need for a national systematic patient-centered outcomes monitoring system. These safety concerns and the exponential growth in TJR use—given the demographics of the baby boomer generation—emphasize the need for systematic comparative effectiveness research (CER) to inform patients, physicians, and policy makers about the optimal practices in TJR surgery.

Evaluation of an automated safety surveillance system using risk adjusted sequential probability ratio testing

Journal  BMC Medical Informatics and Decision Making
Authors Matheny ME; Normand SL; Gross TP; Marinac-Dabic D; Loyo-Berríos N,; Vidi VD; Donnelly S; Resnic FS.
Year Published 2011
Link to Publication

 

Background

Automated adverse outcome surveillance tools and methods have potential utility in quality improvement and medical product surveillance activities. Their use for assessing hospital performance on the basis of patient outcomes has received little attention. We compared risk-adjusted sequential probability ratio testing (RA-SPRT) implemented in an automated tool to Massachusetts public reports of 30-day mortality after isolated coronary artery bypass graft surgery.

Methods

A total of 23,020 isolated adult coronary artery bypass surgery admissions performed in Massachusetts hospitals between January 1, 2002 and September 30, 2007 were retrospectively re-evaluated. The RA-SPRT method was implemented within an automated surveillance tool to identify hospital outliers in yearly increments. We used an overall type I error rate of 0.05, an overall type II error rate of 0.10, and a threshold that signaled if the odds of dying 30-days after surgery was at least twice than expected. Annual hospital outlier status, based on the state-reported classification, was considered the gold standard. An event was defined as at least one occurrence of a higher-than-expected hospital mortality rate during a given year.

Results

We examined a total of 83 hospital-year observations. The RA-SPRT method alerted 6 events among three hospitals for 30-day mortality compared with 5 events among two hospitals using the state public reports, yielding a sensitivity of 100% (5/5) and specificity of 98.8% (79/80).

Conclusions

The automated RA-SPRT method performed well, detecting all of the true institutional outliers with a small false positive alerting rate. Such a system could provide confidential automated notification to local institutions in advance of public reporting providing opportunities for earlier quality improvement interventions.