Original articleComparing Morbidities of Testing With a New Index: Screening Colonoscopy Versus Core-Needle Breast Biopsy
Introduction
As we increasingly focus on providing patient-centered health care, measuring outcomes and specifically “utility” for outcomes of care becomes increasingly important. Utility refers to a preference for a given state of health and disutility to a toll on a health state; a utility scale generally ranges from 0 = dead to 1.0 = full health [1]. Utility for outcomes can be measured directly with multiple methods, such as visual analog scales, standard gamble, or time trade-off assessments or indirectly with various indexes with subscales for specific aspects of a health state (eg, EQ-5D, HUI2/3, and SF-6D) 2, 3. However, intermediate points in care processes that entail such aspects as pain or other side effects, risk for complications, inconvenience, and anxiety also matter to patients [4]. These aspects and others are generally referred to as nonoutcome components of care. Even so, patients derive utility or disutility from such processes [4], and in certain circumstances, “process utility” [5] can affect adherence to treatment or health maintenance guidelines and also longer term outcomes. Therefore, improved measurement of process utility may offer an additional area of opportunity to guide the application of interventions and to improve outcomes 4, 6. Opmeer et al [4] compiled the breadth of health care interventions in the literature that involve nonhealth outcomes. Besides offering a taxonomy for nonhealth outcomes, Opmeer et al also noted the diversity of methods that have been used to value patient preferences in these studies and called for standardization. The National Institute for Health and Care Excellence in the United Kingdom now allows the submission of such process-related data in evaluating health care programs as of its 2013 guidelines [7].
An aspect of interest in medical care process utility is the morbidity of the diagnostic testing or screening experience 8, 9, 10, 11, 12. A recently developed instrument called the Testing Morbidities Index (TMI) is available to quantify the disutility toll from any diagnostic or screening procedure 13, 14. In this investigation, we compared data from two prior studies 14, 15 on differing cancer-related procedures to further assess the construct (known groups) validity of the TMI.
Section snippets
Clinical Patients
Data from patients having undergone recent breast core-needle biopsies were used from a study that was used to develop the TMI [14]. The data used were from a separate group of patients (n = 100) within that study that had been designated for first validation of the index. These patients completed 3 evaluations of their biopsy experiences on a scale ranging from dead (0) to full health (1.0), including a visual analog scale assessment, a waiting trade-off [10] assessment, and the TMI. All
Results
Table 3 summarizes the patient experience scores for screening colonoscopy and breast biopsy, stratified by individual TMI domain and overall summary scores. Five of 7 domains and the overall summary score comparisons were significant. Only 2 domains were not significant given the Bonferroni correction (embarrassment and mental status afterward), but were close to significance. Breast biopsy showed greater morbidity in all domains except pain and discomfort before the test. Breast biopsy,
Discussion
Although the primary emphasis of health service evaluations is on health outcomes, there is a body of literature questioning whether this focus results in “narrow consequentialism,” defined by Mooney as “the monopolization of the utility of welfare function…by health and health alone [21]. Brennan and Dixon [6] further cited Gerard and Mooney’s [22] query as to whether this consequentialism “has led to researchers ignoring other consequence and process issues whose inclusion would take into
Take-Home Points
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There is a growing interest in the quality-of-life effects of the process of medical care (process utility), which may enhance patient-centered outcomes measurement.
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Because millions of people undergo testing and screening, the TMI was developed to assess process utility during the diagnostic process.
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We evaluated data from two prior studies using the TMI and compared two tests: core-needle biopsy of the breast and screening colonoscopy. The comparison showed the expected differing morbidity
Acknowledgments
The authors gratefully acknowledge the assistance of Karen Donelan, ScD, Beverly Gerade, NP, and Katy Marttila.
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This study was supported by the American Cancer Society (114130-RSGHP-07-266-01-CPHPS) and the Massachusetts General Hospital Executive Committee on Research Bridge Fund (1200-218421).