Original article
Comparing Morbidities of Testing With a New Index: Screening Colonoscopy Versus Core-Needle Breast Biopsy

https://doi.org/10.1016/j.jacr.2014.08.014Get rights and content

Abstract

Purpose

Focusing on outcomes of care alone may be too restrictive. Patients can experience morbidity that is important to them from health care processes themselves. However, many processes, such as testing and screening, have been little evaluated. This study’s purpose was to assess the construct validity of a new preference-based index, the Testing Morbidities Index (TMI), by comparing two common cancer-related procedures in prior publications: screening colonoscopy and core-needle breast biopsy.

Methods

Women evaluating their breast biopsies (n = 100) were compared with men and women who had undergone screening colonoscopy (n = 109) after both groups completed the TMI. The TMI addresses physical and mental or emotional quality of life affected by test-specific aspects occurring before, during, or after any test. It has 7 domains and survey items. TMI scores can be scaled in various ways, including multi-attribute value theory–based patient or societal preferences, where 0 = dead and 1.0 = full health, as used here.

Results

There was significantly greater morbidity from breast biopsy (mean, 0.84) than from screening colonoscopy (mean, 0.88) comparing overall TMI preference scores (P < .0001). Breast biopsy showed significantly worse morbidity (P = .005 to P < .0001) in most domains. Pain or discomfort before testing was worse for colonoscopy because of bowel preparation. The TMI showed no floor effect and an acceptable ceiling effect.

Conclusions

The TMI provides the first objective evidence comparing the morbidity of one cancer-related testing procedure with another. The TMI may be useful in assessments of medical care processes informative to institutions and imaging departments, shared decision-making scenarios, and economic analyses.

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

  • 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.

  • Because millions of people undergo testing and screening, the TMI was developed to assess process utility during the diagnostic process.

  • 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.

References (26)

  • J.S. Swan et al.

    Patient preference for magnetic resonance versus conventional angiography. Assessment methods and implications for cost-effectiveness analysis: an overview

    Invest Radiol

    (1998)
  • J.S. Swan et al.

    A time-tradeoff method for cost-effectiveness models applied to radiology

    Med Decis Making

    (2000)
  • J.S. Swan et al.

    Process utility in breast biopsy

    Med Decis Making

    (2006)
  • Cited by (12)

    • Temporary Health Impact of Prostate MRI and Transrectal Prostate Biopsy in Active Surveillance Prostate Cancer Patients

      2019, Journal of the American College of Radiology
      Citation Excerpt :

      SF-12® is a registered trademark of Medical Outcomes Trust (a part of Optum, Eden Prairie, MN). TMI [10,14,15] is a validated survey instrument designed to measure transient testing-related health utility (testing-related quality-of-life measure). The methodology and scoring of the TMI have been described previously by Swan et al [14].

    • Patient-Centered Assessment of the Value of Oral Contrast Material

      2017, Journal of the American College of Radiology
      Citation Excerpt :

      A total of 234 subjects were approached, and 218 subjects consented to participate. The survey was composed of items derived from the Testing Morbidities Index [12-14], as well as oral contrast material–specific questions developed in conjunction with patient advocates and contrast media experts. The full Testing Morbidities Index [12-14] was not administered because portions of the index were not applicable to the patient population.

    View all citing articles on Scopus

    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).

    View full text