scholarly journals Exclusion Criteria as Measurements I: Identifying Invalid Responses

2019 ◽  
Vol 39 (6) ◽  
pp. 693-703
Author(s):  
Barry Dewitt ◽  
Baruch Fischhoff ◽  
Alexander L. Davis ◽  
Stephen B. Broomell ◽  
Mark S. Roberts ◽  
...  
Keyword(s):  
Online Survey ◽  
Health State Valuation ◽  
Measurement Information ◽  
Health State ◽  
Exclusion Criteria ◽  
Health States ◽  
Patient Reported ◽  
Measurement Information System ◽  
Nationally Representative ◽  
Very High

Background. In a systematic review, Engel et al. found large variation in the exclusion criteria used to remove responses held not to represent genuine preferences in health state valuation studies. We offer an empirical approach to characterizing the similarities and differences among such criteria. Setting. Our analyses use data from an online survey that elicited preferences for health states defined by domains from the Patient-Reported Outcomes Measurement Information System (PROMIS®), with a U.S. nationally representative sample ( N = 1164). Methods. We use multidimensional scaling to investigate how 10 commonly used exclusion criteria classify participants and their responses. Results. We find that the effects of exclusion criteria do not always match the reasons advanced for applying them. For example, excluding very high and very low values has been justified as removing aberrant responses. However, people who give very high and very low values prove to be systematically different in ways suggesting that such responses may reflect different processes. Conclusions. Exclusion criteria intended to remove low-quality responses from health state valuation studies may actually remove deliberate but unusual ones. A companion article examines the effects of the exclusion criteria on societal utility estimates.

scholarly journals Exclusion Criteria as Measurements II: Effects on Utility Functions

2019 ◽  
Vol 39 (6) ◽  
pp. 704-716
Author(s):  
Barry Dewitt ◽  
Baruch Fischhoff ◽  
Alexander L. Davis ◽  
Stephen B. Broomell ◽  
Mark S. Roberts ◽  
...  
Keyword(s):  
Online Survey ◽  
Standard Gamble ◽  
Utility Functions ◽  
Measurement Information ◽  
Exclusion Criteria ◽  
Health States ◽  
Companion Article ◽  
Patient Reported ◽  
Health Domains ◽  
Standard Gamble Method

Background. Researchers often justify excluding some responses in studies eliciting valuations of health states as not representing respondents’ true preferences. Here, we examine the effects of applying 8 common exclusion criteria on societal utility estimates. Setting. An online survey of a US nationally representative sample ( N = 1164) used the standard gamble method to elicit preferences for health states defined by 7 health domains from the Patient-Reported Outcomes Measurement Information System (PROMIS®). Methods. We estimate the impacts of applying 8 commonly used exclusion criteria on mean utility values for each domain, using beta regression, a form of analysis suited to double-bounded scales, such as utility. Results. Exclusion criteria have varied effects on the utility functions for the different PROMIS health domains. As a result, applying those criteria would have varied effects on the value of treatments (and side effects) that change health status on those domains. Limitations. Although our method could be applied to any health utility judgments, the present estimates reflect the features of the study that produced them. Those features include the selected health domains, standard gamble method, and an online format that excluded some groups (e.g., visually impaired and illiterate individuals). We also examined only a subset of all possible exclusion criteria, selected to represent the space of possibilities, as characterized in a companion article. Conclusions. Exclusion criteria can affect estimates of the societal utility of health states. We use those effects, in conjunction with the results of the companion article, to make suggestions for selecting exclusion criteria in future studies.

scholarly journals Estimation of a Preference-Based Summary Score for the Patient-Reported Outcomes Measurement Information System: The PROMIS®-Preference (PROPr) Scoring System

2018 ◽  
Vol 38 (6) ◽  
pp. 683-698 ◽  
Author(s):  
Barry Dewitt ◽  
David Feeny ◽  
Baruch Fischhoff ◽  
David Cella ◽  
Ron D. Hays ◽  
...  
Keyword(s):  
Scoring System ◽  
Patient Reported Outcomes ◽  
Online Survey ◽  
Measurement Information ◽  
Scoring Functions ◽  
Health States ◽  
Outcomes Measurement ◽  
Patient Reported ◽  
Single Attribute ◽  
Measurement Information System

Background. Health-related quality of life (HRQL) preference-based scores are used to assess the health of populations and patients and for cost-effectiveness analyses. The National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS®) consists of patient-reported outcome measures developed using item response theory. PROMIS is in need of a direct preference-based scoring system for assigning values to health states. Objective. To produce societal preference-based scores for 7 PROMIS domains: Cognitive Function–Abilities, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Ability to Participate in Social Roles and Activities. Setting. Online survey of a US nationally representative sample ( n = 983). Methods. Preferences for PROMIS health states were elicited with the standard gamble to obtain both single-attribute scoring functions for each of the 7 PROMIS domains and a multiplicative multiattribute utility (scoring) function. Results. The 7 single-attribute scoring functions were fit using isotonic regression with linear interpolation. The multiplicative multiattribute summary function estimates utilities for PROMIS multiattribute health states on a scale where 0 is the utility of being dead and 1 the utility of “full health.” The lowest possible score is –0.022 (for a state viewed as worse than dead), and the highest possible score is 1. Limitations. The online survey systematically excludes some subgroups, such as the visually impaired and illiterate. Conclusions. A generic societal preference-based scoring system is now available for all studies using these 7 PROMIS health domains.

The Patient-Reported Outcomes Measurement Information System in spine surgery: a systematic review

2019 ◽  
Vol 30 (3) ◽  
pp. 405-413 ◽  
Author(s):  
Brittany E. Haws ◽  
Benjamin Khechen ◽  
Mundeep S. Bawa ◽  
Dil V. Patel ◽  
Harmeet S. Bawa ◽  
...  
Keyword(s):  
Systematic Review ◽  
Information System ◽  
Patient Reported Outcomes ◽  
Neck Disability Index ◽  
Measurement Information ◽  
Strong Correlations ◽  
Comprehensive Overview ◽  
Outcomes Measurement ◽  
Patient Reported ◽  
Measurement Information System

OBJECTIVEThe Patient-Reported Outcomes Measurement Information System (PROMIS) was developed to provide a standardized measure of clinical outcomes that is valid and reliable across a variety of patient populations. PROMIS has exhibited strong correlations with many legacy patient-reported outcome (PRO) measures. However, it is unclear to what extent PROMIS has been used within the spine literature. In this context, the purpose of this systematic review was to provide a comprehensive overview of the PROMIS literature for spine-specific populations that can be used to inform clinicians and guide future work. Specifically, the authors aimed to 1) evaluate publication trends of PROMIS in the spine literature, 2) assess how studies have used PROMIS, and 3) determine the correlations of PROMIS domains with legacy PROs as reported for spine populations.METHODSStudies reporting PROMIS scores among spine populations were identified from PubMed/MEDLINE and a review of reference lists from obtained studies. Articles were excluded if they did not report original results, or if the study population was not evaluated or treated for spine-related complaints. Characteristics of each study and journal in which it was published were recorded. Correlation of PROMIS to legacy PROs was reported with 0.1 ≤ |r| < 0.3, 0.3 ≤ |r| < 0.5, and |r| ≥ 0.5 indicating weak, moderate, and strong correlations, respectively.RESULTSTwenty-one articles were included in this analysis. Twelve studies assessed the validity of PROMIS whereas 9 used PROMIS as an outcome measure. The first study discussing PROMIS in patients with spine disorders was published in 2012, whereas the majority were published in 2017. The most common PROMIS domain used was Pain Interference. Assessments of PROMIS validity were most frequently performed with the Neck Disability Index. PROMIS domains demonstrated moderate to strong correlations with the legacy PROs that were evaluated. Studies assessing the validity of PROMIS exhibited substantial variability in PROMIS domains and legacy PROs used for comparisons.CONCLUSIONSThere has been a recent increase in the use of PROMIS within the spine literature. However, only a minority of studies have incorporated PROMIS for its intended use as an outcomes measure. Overall, PROMIS has exhibited moderate to strong correlations with a majority of legacy PROs used in the spine literature. These results suggest that PROMIS can be effective in the assessment and tracking of PROs among spine populations.

Evaluation of PROMIS Outcomes for Surgical Treatment of Cubital Tunnel Syndrome With and Without Carpal Tunnel Syndrome

Hand ◽  
2021 ◽  
pp. 155894472110289
Author(s):  
Amy Phan ◽  
Warren Hammert
Keyword(s):  
Carpal Tunnel Syndrome ◽  
Carpal Tunnel ◽  
Postoperative Period ◽  
Cubital Tunnel Syndrome ◽  
Cubital Tunnel ◽  
Measurement Information ◽  
Level Of Evidence ◽  
Patient Reported ◽  
Tunnel Syndrome ◽  
Measurement Information System

Background: Assessment of outcomes for cubital tunnel syndrome (CuTS) surgeries has been difficult due to heterogeneity in outcome reporting. Our objective was to evaluate the outcomes for 2 cohorts treated surgically for isolated CuTS and for combined CuTS and carpal tunnel syndrome (CTS) using Patient Reported Outcomes Measurement Information System (PROMIS). Methods: There were 29 patients in the isolated CuTS cohort and 30 patients in the combined CuTS and CTS cohort. PROMIS Physical Function (PF), Pain Interference (PI), Depression, and Upper Extremity (UE) were completed preoperatively and 1-week, 6-weeks, and 3-months postoperatively. Responsiveness was evaluated by standardized response means (SRM). Results: Significant improvements from the 1-week to 6-week postoperative period are shown in the isolated CuTS cohort for PROMIS PF ( P = .002), PI ( P = .0002), and UE ( P = .02), but scores plateau after 6-weeks postoperatively. A similar pattern for the same time points was seen for the combined CuTS and CTS group for PROMIS PF ( P = .001), PI ( P = .02), and UE ( P = .04), with a plateau of scores beyond 6 weeks postoperatively. PROMIS UE was more responsive (SRM range: 0.11-1.03) than the PF (SRM range: 0.02-0.52) and PI (SRM range: 0.11-0.40), which were both mildly responsive for both cohorts. Conclusions: PROMIS lacks the sensitivity to show improvement beyond 6-weeks postoperatively for both isolated CuTS and combined CuTS and CTS. Patients with combined nerve compressions follow similar trajectories in the postoperative period as those with isolated CuTS. Level of Evidence: Level IV.

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