Development and content validation of measures assessing adherence barriers and behaviors for use in clinical care

R J Fredericksen; F M Yang; L E Gibbons; T C Edwards; S Brown; E Fitzsimmons; K Alperovitz-Bichell; M Godfrey; A Wang; A Church; C Gutierrez; E Paez; L Dant; S Loo; M Walcott; M J Mugavero; K H Mayer; W C Mathews; D L Patrick; P K Crane; H M Crane

doi:10.1016/j.sapharm.2018.10.001

Development and content validation of measures assessing adherence barriers and behaviors for use in clinical care

Res Social Adm Pharm. 2019 Sep;15(9):1168-1176. doi: 10.1016/j.sapharm.2018.10.001. Epub 2018 Oct 5.

Authors

R J Fredericksen¹, F M Yang², L E Gibbons³, T C Edwards⁴, S Brown³, E Fitzsimmons³, K Alperovitz-Bichell⁵, M Godfrey⁶, A Wang⁵, A Church³, C Gutierrez⁷, E Paez⁸, L Dant⁷, S Loo⁷, M Walcott⁹, M J Mugavero⁹, K H Mayer⁷, W C Mathews⁸, D L Patrick⁴, P K Crane³, H M Crane³

Affiliations

¹ University of Washington, Center for AIDS Research, 325 Ninth Avenue, Box 359931, Seattle, WA, 98104, USA. Electronic address: rfrederi@uw.edu.
² Augusta University, 1120 15th Street Augusta, GA, 30912, USA.
³ University of Washington, Center for AIDS Research, 325 Ninth Avenue, Box 359931, Seattle, WA, 98104, USA.
⁴ University of Washington, Quality of Life Group, Box 359455, Seattle, WA, 98195, USA.
⁵ Chase Brexton Health Care, 5500 Knoll N Dr #370, Columbia, MD, 21045, USA.
⁶ Beaufort Jasper Hampton Comprehensive Health Services, 1520 Grays Highway, Ridgeland, SC, 29936, USA.
⁷ Fenway Community Health, 1340 Boylston Street, Boston, MA, 02215, USA.
⁸ University of California-San Diego, The Owen Clinic, 4168 Front Street, San Diego, CA, 92103, USA.
⁹ University of Alabama-Birmingham, 1917 Clinic, Community Care Building, 908 South 20th Street, Birmingham, AL, 35294, USA.

Abstract

Background: Providers are often unaware of poor adherence to prescribed medications for their patients with chronic diseases.

Objective: To develop brief, computer-administered patient-reported measures in English and Spanish assessing adherence behaviors and barriers. Design, Participants, and Main Measures: Item pools were constructed from existing measures of medication adherence behaviors and barriers, which informed development of a patient concept elicitation interview guide to identify medication adherence behavior and barrier-related concepts. Two hundred six patients either living with HIV (PLWH) or without were interviewed. Interviews were coded, concepts matched to item pool content, and new items were developed for novel concepts. A provider/investigator team highlighted clinically relevant items. Cognitive interviews were conducted with patients on final candidate items (n = 37). The instruments were administered to 2081 PLWH.

Key results: Behavioral themes from concept elicitation interviews included routines incorporating time of day, placement, visual cues, and intentionality to miss or skip doses. Barrier themes included health-related (e.g. depressed mood, feeling ill), attitudes/beliefs (e.g., need for medication), access (e.g., cost/insurance problems), and circumstantial barriers (e.g., lack of privacy, disruption of daily routine). The final instruments included 6 behavior items, and 1 barrier item with up to 23 response options. PLWH endorsed a mean (SD) of 3.5 (1.1) behaviors. The 201 PLWH who missed ≥2 doses in the previous week endorsed a mean (SD) of 3.1 (2.5) barriers. The intraclass correlation coefficient (ICC) for the numbers of behaviors endorsed in 61 PLWH after 4-16 days was 0.54 and for the number of barriers for the 20 PLWH with ≥2 missed doses the ICC was 0.89, representing fair and excellent test-retest reliability.

Conclusion: Measures of medication adherence behaviors and barriers were developed for use with patients living with chronic diseases focusing on clinical relevance, brevity, and content validity for use in clinical care.

Keywords: Medication adherence; Patient-reported outcomes.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

Adult
Chronic Disease / drug therapy*
Female
HIV Infections / drug therapy*
Humans
Male
Medication Adherence / statistics & numerical data*
Middle Aged
Self Report

Abstract

Publication types

MeSH terms

Grants and funding