BACKGROUND: Medication non-adherence is a common issue in chronic illness. The World Health Organization has recognized a need for a valid and reliable method of measuring adherence to understand and mitigate non-adherence. This study aimed to psychometrically evaluate the English version of the Adelphi Adherence Questionnaire (ADAQ©), a questionnaire designed to assess patient-reported medication adherence across multiple therapy areas, in patients with Osteoarthritis (OA). METHODOLOGY: Data from the Adelphi OA Disease Specific Programme™, a survey of physicians and their consulting adult patients with OA conducted in the United States, November 2020 to March 2021, was used to assess the psychometric properties of the ADAQ. Patients completed the ADAQ, Adherence to Refills and Medication Scale (ARMS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), and EQ-5D-3L. The measurement model of the 13-item ADAQ was assessed and refined using latent variable modelling (Multiple Indicator Multiple Cause, confirmatory and exploratory factor analyses, item response theory, Mokken scaling, and bifactor analyses). Correlational analyses (Spearman's rank and polyserial as appropriate) with ARMS, WOMAC, and EQ-5D-3L scores assessed construct validity. Anchor- and distribution-based analyses were performed to estimate between-group clinically important differences (CID). RESULTS: Overall, 723 patients were included in this analysis (54.5% female, 69.0% aged ≥ 60). Latent variable modelling indicated a unidimensional reflective model was appropriate, with a bifactor model confirming an 11-item essentially unidimensional score. Items 12 and 13 were excluded from scoring as they measured a different concept. The ADAQ had high internal reliability with omega hierarchical and Cronbach's alpha coefficients of 0.89 and 0.97, respectively. Convergent validity was supported by moderate correlations with items of the ARMS, and physician-reported adherence and compliance. Mean differences in ADAQ score between high and low adherence groups yielded CID estimates between 0.49 and 1.05 points, with a correlation-weighted average of 0.81 points. CONCLUSION: This scoring model showed strong construct validity and internal consistency reliability when assessing medication adherence in OA. Future work should focus on confirming validity across a range of disease areas.

Adelphi Real World Bollington UK

Adelphi Values Adelphi Mill Grimshaw Lane Bollington Macclesfield SK10 5JB UK

Department of Kinanthropology Charles University Prague Czechia

Zobrazit více v PubMed

National Instititute for Health and Care Excellence (2009) Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. Available via https://www.nice.org.uk/guidance/cg76/chapter/introduction. Accessed: 16 Aug 2023

Mir TH (2023) Adherence Versus Compliance. HCA Healthc J Med 4(2):219–220. 10.36518/2689-0216.1513 PubMed PMC

DiMatteo MR (2004) Variations in patients’ adherence to medical recommendations: a quantitative review of 50 years of research. Med Care Mar 42(3):200–209. 10.1097/01.mlr.0000114908.90348.f9 PubMed

Jüngst C, Gräber S, Simons S, Wedemeyer H, Lammert F (2019) Medication adherence among patients with chronic diseases: a survey-based study in pharmacies. QJM: Int J Med 112(7):505–512. 10.1093/qjmed/hcz058 PubMed

Brown MT, Bussell JK (2011) Medication Adherence: WHO Cares? Mayo Clin Proc;86(4):304–314. 10.4065/mcp.2010.0575 PubMed PMC

Cea-Calvo L, Marín-Jiménez I, de Toro J et al (2020) Different associations of intentional and non-intentional non-adherence behaviors with patient experience with Healthcare and Patient beliefs in medications: a survey of patients with chronic conditions. Patient Prefer Adherence 14:2439–2450. 10.2147/ppa.S281985 PubMed PMC

Brown MT, Bussell JK (2011) Apr. Medication adherence: WHO cares? Mayo Clin Proc 86(4):304– 14. 10.4065/mcp.2010.0575 PubMed PMC

Lam WY, Fresco P (2015) Medication adherence measures: an overview. Biomed Res Int 2015:217047. 10.1155/2015/217047 PubMed PMC

Lomper K, Chabowski M, Chudiak A, Białoszewski A, Dudek K, Jankowska-Polańska B (2018) Psychometric evaluation of the Polish version of the adherence to refills and medications Scale (ARMS) in adults with hypertension. Patient Prefer Adherence 12:2661–2670. 10.2147/ppa.S185305 PubMed PMC

Kripalani S, Risser J, Gatti ME, Jacobson TA (2009) Development and evaluation of the adherence to refills and medications Scale (ARMS) among low-literacy patients with chronic disease. Value Health Jan-Feb 12(1):118–123. 10.1111/j.1524-4733.2008.00400.x PubMed

Thompson K, Kulkarni J, Sergejew AA (2000) Reliability and validity of a new Medication Adherence Rating Scale (MARS) for the psychoses. Schizophr Res May 5(3):241–247. 10.1016/s0920-9964(99)00130-9 PubMed

Morisky DE, Green LW, Levine DM (1986) Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care Jan 24(1):67–74. 10.1097/00005650-198601000-00007 PubMed

Culig J, Leppée M (2014) From Morisky to Hill-bone; self-reports scales for measuring adherence to medication. Coll Antropol Mar 38(1):55–62 PubMed

Patrick DL, Burke LB, Gwaltney CJ et al (2011) Content validity—establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1—eliciting concepts for a new PRO instrument. Value Health 14(8):967–977 PubMed

Committee for Medicinal Products for Human Use (2005) Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. Eur Med Agency, London

FDA (2019) Patient-focused drug development: methods to identify what is important to patients guidance for industry, food and drug administration staff, and other stakeholders [DRAFT]. US Food and Drug Administration

FDA (2020) Patient-focused drug development: collecting comprehensive and representative input; guidance for industry, food and drug administration staff, and other stakeholders. US Food and Drug Administration

FDA (2012) Guidance for Industry. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims PubMed PMC

Willis GB (2004) Cognitive interviewing: a tool for improving questionnaire design. sage

Morgan L, Exall E, Bentley S et al (2020) AD2 qualitative interviews to explore drivers and Behaviours Associated with Medication NON-Adherence across a range of diseases, Treatment modalities, and Countries. Value Health 23:S399

Bentley S, Morgan L, Exall E et al (2022) Qualitative interviews to Support Development and Cognitive Debriefing of the Adelphi Adherence Questionnaire (ADAQ©): a patient-reported measure of Medication Adherence developed for Use in a range of diseases, Treatment modalities, and Countries. Patient Prefer Adherence 16:2579–2592. 10.2147/ppa.S358046 PubMed PMC

Bentley S, Exall E, Morgan L et al Improving Assessment of Adherence behaviors and drivers: targeted Literature Review and Concept Elicitation interviews in multiple countries and Disease populations. Patient Prefer Adherence. 2024/12/31 2024;18(null):1231–1242. 10.2147/PPA.S433662 PubMed PMC

United States Bone and Joint Initiative. The Burden of Musculoskeletal Diseases in the United States (BMUS). In: Fourth ed. Rosemont, IL (2018): https://www.boneandjointburden.org/fourth-edition. Accessed 16 Mar 2023

Hunter DJ, Schofield D, Callander E (2014) The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol 2014;10(7):437–441. 10.1038/nrrheum.2014.44 PubMed

Park KK, Choi CH, Ha CW, Lee MC (2016) The effects of Adherence to non-steroidal anti-inflammatory drugs and factors influencing drug adherence in patients with knee osteoarthritis. J Korean Med Sci May 31(5):795–800. 10.3346/jkms.2016.31.5.795 PubMed PMC

Anderson P, Benford M, Harris N, Karavali M, Piercy J (2008) Real-world physician and patient behaviour across countries: Disease-Specific programmes - a means to understand. Curr Med Res Opin Nov 24(11):3063–3072. 10.1185/03007990802457040 PubMed

Anderson P, Higgins V, Courcy J et al (2023) Real-world evidence generation from patients, their caregivers and physicians supporting clinical, regulatory and guideline decisions: an update on Disease Specific Programmes. Curr Med Res Opin Dec 39(12):1707–1715. 10.1080/03007995.2023.2279679 PubMed

Babineaux SM, Curtis B, Holbrook T, Milligan G, Piercy J (2016) Evidence for validity of a national physician and patient-reported, cross-sectional survey in China and UK: the Disease Specific Programme. BMJ Open 6(8):e010352. 10.1136/bmjopen-2015-010352 PubMed PMC

Higgins V, Piercy J, Roughley A et al (2016) Trends in medication use in patients with type 2 diabetes mellitus: a long-term view of real-world treatment between 2000 and 2015. Diabetes Metab Syndr Obes 9:371–380. 10.2147/dmso.S120101 PubMed PMC

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW (1988) Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol Dec 15(12):1833–1840 PubMed

EuroQol Group (1990) EuroQol–a new facility for the measurement of health-related quality of life. Health Policy 16(3):199–208. 10.1016/0168-8510(90)90421-9 PubMed

Voils CI, Maciejewski ML, Hoyle RH et al (2012) Initial validation of a self-report measure of the extent of and reasons for medication nonadherence. Med Care Dec 50(12):1013–1019. 10.1097/MLR.0b013e318269e121 PubMed PMC

Voils CI, Hoyle RH, Thorpe CT, Maciejewski ML, Yancy WS Jr (2011) Improving the measurement of self-reported medication nonadherence. J Clin Epidemiol Mar 64(3):250–254. 10.1016/j.jclinepi.2010.07.014 PubMed PMC

Bollen K, Lennox R (1991) Conventional wisdom on measurement: a structural equation perspective. Psychol Bull 110:305–314

Kline RB (2005) Principles and practice of structural equation modeling, 2nd ed. Principles and practice of structural equation modeling, 2nd ed. New York, NY, US: Guilford Press; p. xviii, 366-xviii, 366

Hu L-t, Bentler PM (1999) Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives. Struct Equ Model 6:1–55. 10.1080/10705519909540118

Shi D, Maydeu-Olivares A, Rosseel Y (2020) Assessing Fit in Ordinal Factor Analysis Models: SRMR vs. RMSEA. Struct Equ Modeling 27(1):1–15. 10.1080/10705511.2019.1611434

Stochl J, Fried EI, Fritz J et al (2022) On dimensionality, Measurement Invariance, and suitability of Sum scores for the PHQ-9 and the GAD-7. Assess Apr 29(3):355–366. 10.1177/1073191120976863 PubMed

Stochl J, Jones PB, Croudace TJ (2012) Mokken scale analysis of mental health and well-being questionnaire item responses: a non-parametric IRT method in empirical research for applied health researchers. BMC Med Res Methodol Jun 11:12:74. 10.1186/1471-2288-12-74 PubMed PMC

Christensen AP, Garrido LE, Guerra-Peña K, Golino H (2020) Comparing community detection algorithms in psychological data: a Monte Carlo simulation. 10.31234/osf.io/hz89e PubMed

Friedman J, Hastie T, Tibshirani R (2008) Sparse inverse covariance estimation with the graphical lasso. Biostatistics 9(3):432–441. 10.1093/biostatistics/kxm045 PubMed PMC

Golino HF, Epskamp S (2017) Exploratory graph analysis: a new approach for estimating the number of dimensions in psychological research. PLoS ONE 12(6):e0174035. 10.1371/journal.pone.0174035 PubMed PMC

Reise SP, Moore TM, Haviland MG (2010) Bifactor models and rotations: exploring the extent to which multidimensional data yield univocal scale scores. J Pers Assess Nov 92(6):544–559. 10.1080/00223891.2010.496477 PubMed PMC

McDonald RP (1999) Test theory: a unified treatment. Lawrence Erlbaum Associates Publishers, vol xi. p 485

Steiger JH (1980) Tests for comparing elements of a correlation matrix. Psychol Bull 87(2):245–251

Revicki D, Hays RD, Cella D, Sloan J (2008) Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol Feb 61(2):102–109. 10.1016/j.jclinepi.2007.03.012 PubMed

Mamolo C, Bushmakin A, Cappelleri J (2014) Application of the itch severity score in patients with moderate-to-severe plaque psoriasis: clinically important difference and responder analyses*. J Dermatolog Treat 04/10(26). 10.3109/09546634.2014.906033 PubMed

Trigg A, Griffiths P (2021) Triangulation of multiple meaningful change thresholds for patient-reported outcome scores. Qual Life Res Oct 30(10):2755–2764. 10.1007/s11136-021-02957-4 PubMed

Revelle W (2021) psych: Procedures for Personality and Psychological Research. Northwestern University, Evanston, Illinois, USA. https://CRAN.R-project.org/package=psych Version = 2.1.9

Rosseel Y (2012) Lavaan: an R Package for Structural equation modeling. J Stat Softw 48(2):1–36. https://www.jstatsoft.org/v48/i02/

Philip Chalmers R (2012) Mirt: a Multidimensional Item Response Theory Package for the R environment. J Stat Softw 1–29. 10.18637/jss.v048.i06

Hallquist MN, Wiley JF (2018) MplusAutomation: an R Package for Facilitating large-scale latent variable analyses in Mplus. Struct Equ Model 25(4):621–638. 10.1080/10705511.2017.1402334 PubMed PMC

Dueber D (2021) BifactorIndicesCalculator Bifactor Indices Calculator. R package version 0.2.2. https://CRAN.R-project.org/package=BifactorIndicesCalculator

Golino H, Christensen AP (2021) EGAnet: exploratory graph analysis– a framework for estimating the number of dimensions in multivariate data using network psychometrics. R package version 0.9.9

van der Ark LA (2012) New Developments in Mokken Scale Analysis in R. J Stat Softw 05/24 48(5):1–27. 10.18637/jss.v048.i05

Suda T, Traxler A (2020) concorR: CONCOR and Supplemental Functions. R package version 0.2.1, https://github.com/ATraxLab/concorR

Streiner DL, Norman GR, Cairney J (2015) Health measurement scales: a practical guide to their development and use, 5th ed, vol xiii. Oxford University Press, p 399

Widaman KF, Revelle W (2024/08/01 2023) Thinking About Sum Scores Yet Again, Maybe the Last Time, We Don’t Know, Oh No.: A Comment on. Educ Psychol Meas 84(4):637–659. 10.1177/00131644231205310 PubMed PMC

McNeish D, Wolf MG (2020) Thinking twice about sum scores. Behav Res Methods Dec 52(6):2287–2305. 10.3758/s13428-020-01398-0 PubMed

McNeish D, Wolf MG (2020) Corrigendum to: Thinking twice about sum scores. Behav Res Methods 52(6):2674–2674. 10.3758/s13428-020-01468-3 PubMed

McNeish D (2023) Psychometric properties of sum scores and factor scores differ even when their correlation is 0.98: a response to Widaman and Revelle. Behav Res Methods Dec 55(8):4269–4290. 10.3758/s13428-022-02016-x PubMed

Widaman KF, Revelle W (2023) Thinking thrice about sum scores, and then some more about measurement and analysis. Behav Res Methods 2023;55(2):788–806. 10.3758/s13428-022-01849-w PubMed PMC

Barbosa CD, Balp MM, Kulich K, Germain N, Rofail D (2012) A literature review to explore the link between treatment satisfaction and adherence, compliance, and persistence. Patient Prefer Adherence 6:39–48. 10.2147/ppa.S24752 PubMed PMC

Robinson RL, Schnitzer TJ, Barlow S et al (2022) Satisfaction with medications prescribed for Osteoarthritis: a cross-sectional survey of patients and their Physicians in the United States. Pain Ther Mar 11(1):191–208. 10.1007/s40122-021-00350-0 PubMed PMC

Sidorkiewicz S, Tran VT, Cousyn C, Perrodeau E, Ravaud P (Sep 2016) Discordance between drug adherence as reported by patients and drug importance as assessed by Physicians. Ann Fam Med 14(5):415–421. 10.1370/afm.1965 PubMed PMC

Stirratt MJ, Dunbar-Jacob J, Crane HM et al (2015) Self-report measures of medication adherence behavior: recommendations on optimal use. Transl Behav Med Dec 5(4):470–482. 10.1007/s13142-015-0315-2 PubMed PMC

Lee W-Y, Ahn J, Kim J-H et al (2013) Reliability and validity of a self-reported measure of medication adherence in patients with type 2 diabetes mellitus in Korea. J Int Med Res 41(4):1098–1110 PubMed

Schepman P, Thakkar S, Robinson R, Malhotra D, Emir B, Beck C (2021) Moderate to severe osteoarthritis pain and its impact on patients in the United States: a National Survey. J Pain Res 14:2313–2326. 10.2147/JPR.S310368 PubMed PMC

European Pharmaceutical Market Research Association (EphMRA). Code of Conduct. Accessed 21 Mar 2022. https://www.ephmra.org/media/4857/ephmra-2020-code-of-conduct-final.pdf

US Department of Health and Human Services. Summary of the HIPAA Privacy Rule. Accessed 21 Mar 2023. http://www.hhs.gov/sites/default/files/privacysummary.pdf

Health Information Technology (HITECH). Health Information Technology Act. Accessed 21 Mar 2023. https://www.healthit.gov/sites/default/files/hitech_act_excerpt_from_arra_with_index.pdf

World Health Association (2013) World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 310(20):2191–2194 PubMed