PHP146 - The Frequency and Availability of Population-Specific Patient Reported Outcome Measures and Minimal Clinically Important Differences Among Approved Drugs in Canada

Al Soprovich,M Ingstrup,Dt Eurich

doi:10.1016/j.jval.2018.04.741

Al Soprovich, M Ingstrup + Show 1 more

Open Access

https://doi.org/10.1016/j.jval.2018.04.741

Copy DOI

Journal: Value in Health	Publication Date: May 1, 2018
License type: publisher-specific-oa

Affiliation: University of Alberta

Abstract

Patient reported outcome measures (PROMs) and minimal clinically important differences (MCIDs) are included in Canada’s Common Drug Review (CDR) process to approve new drugs. Often, the measures report on the health-related quality of life (HRQoL), but can also describe the symptoms, efficacy and harms important to patients. They can be generic or population/condition specific, validated or not. We examined the frequency, availability and accessibility of validated, specific PROMs and MCIDs reported in the CDR reports. We searched the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database for completed Common Drug Review, Clinical Review Reports (CDR-CRR) between November 2013 and February 2017. Two independent reviewers examined the reports and references for PROMs and MCIDs. Both reviewers separately categorized the PROMs and MICDs according to purpose, validation, availability and funding received. Discrepancies were rectified by consensus with a third investigator. One-hundred and five unique PROMs were extracted from 39 CDR-CRR, 57% with a HRQoL component. 91/105 (87%) referenced a validation study and 62/105 (59%) referenced a validation study in the study population of interest. Fifty-seven MCID references were extracted from 39 CDR-CRR. 34/57 (60%) were specific to the study population of interest, and 36% had a HRQoL component. 50% of PROM and 53% of MCID references were publicly available. PROMs and MCIDs referenced in CDR-CRR show similar trends. The majority are validated, but not necessarily in the study population of interest. Continued critical examination is required to evaluate new drugs specific to the population of interest.

Highlights

PHP146 The Frequency and Availability of Population-Specific Patient Reported Outcome Measures and Minimal Clinically Important Differences Among Approved Drugs in Canada Soprovich AL, Ingstrup M, Eurich DT University of Alberta, Edmonton, AB, Canada Objectives: Patient reported outcome measures (PROMs) and minimal clinically important differences (MCIDs) are included in Canada’s Common Drug Review (CDR) process to approve new drugs
While studying the trend in incremental quality-adjusted life year (QALY) reported in cost-effectiveness analyses (CEAs) would directly answer this question of declining marginal gains, we study here a potential behavioral response by researchers seeking to establish the value of interventions
Using a formula developed by Revicki et al and patient responses to the Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 assessment, as well as their demographic information, we were able to calculate the number of added QALYs for patients with chronic conditions that participated in a digital health coaching program

Summary

Introduction

PHP146 The Frequency and Availability of Population-Specific Patient Reported Outcome Measures and Minimal Clinically Important Differences Among Approved Drugs in Canada Soprovich AL, Ingstrup M, Eurich DT University of Alberta, Edmonton, AB, Canada Objectives: Patient reported outcome measures (PROMs) and minimal clinically important differences (MCIDs) are included in Canada’s Common Drug Review (CDR) process to approve new drugs. We explore whether utility weights used in CEAs show a trend toward more significant digits. Each year since 2002, the probability that a health-state utility weight was reported with three or more significant digits increased by 8.3% (95% CI: 7.2-9.4%, p < 0.001).

Objectives

Results

Conclusion