Comparing morbidities of testing with a new index: screening colonoscopy versus core-needle breast biopsy.

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.

Percutaneous breast biopsy: effect on short-term quality of life.

PURPOSE: To examine the effects of percutaneous breast biopsy on short-term quality of life. MATERIALS AND METHODS: The institutional review board approved this HIPAA-compliant prospective study. From December 1, 2007, through February 28, 2010, women undergoing percutaneous breast biopsy in an academic medical center were recruited to participate in a mixed-mode survey 2-4 days after biopsy. Patients described their biopsy experience by using the Testing Morbidities Index (TMI), a validated instrument for assessing short-term quality of life related to diagnostic testing. The scale ranged from 0 (worst possible experience) to 100 (no adverse effects). Seven attributes were assessed: pain or discomfort before and during testing, fear or anxiety before and during testing, embarrassment during testing, and physical and mental function after testing. Demographic and clinical information were also collected. Univariate and multivariate linear regression analyses were performed to identify significant predictors of TMI score. RESULTS: In 188 women (mean age, 51.4 years; range, 22-80 years), the mean TMI score (±standard deviation) was 82 ± 12. Univariate analysis revealed age and race as significant predictors of the TMI score (P < .05). In the multivariate model, only patient age remained a significant independent predictor (P = .001). TMI scores decreased by approximately three points for every decade decrease in patient age, which suggests that younger women were more adversely affected by the biopsy experience. CONCLUSION: Younger patient age is a significant predictor of decreased short-term quality of life related to percutaneous breast biopsy procedures. Tailored prebiopsy counseling may better prepare women for percutaneous biopsy procedures and improve their experience.

Patient and societal value functions for the testing morbidities index.

BACKGROUND: We developed preference-based and summated scale scoring for the Testing Morbidities Index (TMI) classification, which addresses short-term effects on quality of life from diagnostic testing before, during, and after testing procedures. METHODS: The two TMI preference functions use multiattribute value techniques; one is patient-based and the other has a societal perspective, informed by 206 breast biopsy patients and 466 (societal) subjects. Because of a lack of standard short-term methods for this application, we used the visual analog scale (VAS). Waiting tradeoff (WTO) tolls provided an additional option for linear transformation of the TMI. We randomized participants to 1 of 3 surveys: The first derived weights for generic testing morbidity attributes and levels of severity with the VAS; a second developed VAS values and WTO tolls for linear transformation of the TMI to a "dead-healthy" scale; the third addressed initial validation in a specific test (breast biopsy). The initial validation included 188 patients and 425 community subjects. Direct VAS and WTO values were compared with the TMI. Alternative TMI scoring as a nonpreference summated scale was included, given evidence of construct and content validity. RESULTS: The patient model can use an additive function, whereas the societal model is multiplicative. Direct VAS and the VAS-scaled TMI were correlated across modeling groups (r = 0.45-0.62). Agreement was comparable to the value function validation of the Health Utilities Index 2. Mean absolute difference (MAD) calculations showed a range of 0.07-0.10 in patients and 0.11-0.17 in subjects. MAD for direct WTO tolls compared with the WTO-scaled TMI varied closely around 1 quality-adjusted life day. CONCLUSIONS: The TMI shows initial promise in measuring short-term testing-related health states.