Adherence measurement and patient recruitment methods are poor in intervention trials to improve patient adherence

Jeffery, Rebecca A.; Navarro, Tamara; Wilczynski, Nancy L.; Iserman, Emma; Keepanasseril, Arun; Sivaramalingam, Bhairavi; Agoritsas, Thomas; Haynes, R. Brian

doi:10.1016/j.jclinepi.2014.06.008

Cited by 38 publications

(34 citation statements)

References 13 publications

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“…15–17 Subjective methods such as patient reports are unreliable 2,16 and are considered to be inferior to objective methods. 18 On the other hand, objective methods, such as pill counts or electronic monitoring, frequently impose additional burden on the patient, and may require significant logistic support. 19,20 Increased patient burden matters because nonadherent patients are not likely to cooperate with a procedure that increases their burden.…”

Section: Introductionmentioning

confidence: 99%

The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study

Shemesh

Bucuvalas

Anand

et al. 2017

American Journal of Transplantation

110

189

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Nonadherence to immunosuppressant medications is a leading cause of poor long-term outcomes in transplant recipients. The Medication Level Variability Index (MLVI) provides a vehicle for transplant outcome risk-stratification through continuous assessment of adherence. The MALT (Medication Adherence in children who had a Liver Transplant) prospective multi-site study evaluated whether MLVI predicts Late Acute Rejection (LAR). 400 pediatric (1–17 year old) liver transplant recipients were enrolled and followed for 2 years. The a-priori hypothesis was that a higher MLVI predicts LAR. Pre-defined secondary analyses evaluated other outcomes such as liver enzyme levels, and sensitivity analyses compared adolescent to pre-adolescents. In the primary analysis sample of 379 participants, a higher pre-rejection MLVI predicted LAR [mean pre-rejection MLVI with LAR: 2.4 (3.6 SD) vs. without LAR, 1.6 (1.1); p=0.026]. 53% of the adolescents with MLVI>2 in year 1 had LAR by the end of year 2, as compared with 6% of those with year 1 MLVI≤2. A higher MLVI was significantly associated with all secondary outcomes. MLVI, a marker of medication adherence that uses clinically-derived information, predicts LAR in pediatric liver transplant recipients.

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Section: Introductionmentioning

confidence: 99%

The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study

Shemesh

Bucuvalas

Anand

et al. 2017

American Journal of Transplantation

110

189

View full text Add to dashboard Cite

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“…There are direct and indirect methods of adherence assessment; however, it seems impossible to point out one as clearly the best tool for measurement [23][24][25][26]. Observation of the treatment process and plasma concentrations of the medication or its metabolites, as well as biological markers, are proposed as direct methods allowing the assessment of adherence [27][28][29][30].…”

Section: Introductionmentioning

confidence: 99%

Self-reported questionnaires for assessment adherence to treatment in patients with cardiovascular diseases

Kubica

Kosobucka

Michalski

et al. 2018

Medical Research Journal

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“…There is a wide variety of methods to estimate adherence, each with their specific advantages and disadvantages . Methods that use electronic records (e.g.…”

Section: Introductionmentioning

confidence: 99%

Estimating time‐varying drug adherence using electronic records: extending the proportion of days covered (PDC) method

Bijlsma

Janssen

Hak

2015

Pharmacoepidemiology and Drug

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Abstract:Purpose: Accurate measurement of drug adherence is essential for valid risk-benefit assessments of pharmacologic interventions. To date, measures of drug adherence have almost exclusively been applied for a fixed-time interval, and without considering changes over time. However, patients with irregular dosing behavior commonly have a different prognosis than patients with stable dosing behavior. Methods: We propose a method, based on the Proportion of Days Covered (PDC) method, to measure time-varying drug adherence and drug potency using electronic records. We use an irregularly dosing patient and a patient with stable adherence as examples. For these patients, we compare both a static PDC method with the time varying PDC method. Results: We demonstrate that time varying PDC method better distinguishes an irregularly dosing patient from a stably dosing patient, and demonstrate how the static method can result in a biased estimate of drug adherence. Furthermore, the time varying PDC method may be better used to reduce certain types of confounding and misclassification of exposure. Conclusions: The time varying PDC method may improve longitudinal and time-to-event studies that associate adherence with a clinical outcome, or (intervention) studies that seek to describe changes in adherence over time.http://mc.manuscriptcentral.com/pds Pharmacoepidemiology and Drug Safety 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 4• We demonstrate a method to measure time varying drug adherence, which better 5 distinguishes an irregularly dosing patient from a stably dosing patient, and which is 6 less likely to produce biased estimates. 7• The time varying PDC method may improve longitudinal and time-to-event studies 8 that associate adherence with a clinical outcome, or (intervention) studies that seek to 9 describe changes in adherence over time. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 time interval has passed. In all, time-constant drug adherence measures are disadvantageous 22 both in studies assessing cumulative incidence ratios and incidence rate ratios. 23There is a wide variety of methods to estimate adherence, each with their specific 24 advantages and disadvantages [6,[9][10][11][12][13] The extended PDC method is intended to be applied to data from drug prescription or 3 dispensing records. Initially, data should be ordered such that each row represents a single 4 drug prescription (or dispensed prescription). The in...

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Adherence measurement and patient recruitment methods are poor in intervention trials to improve patient adherence

Cited by 38 publications

References 13 publications

The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study

The Medication Level Variability Index (MLVI) Predicts Poor Liver Transplant Outcomes: A Prospective Multi-Site Study

Self-reported questionnaires for assessment adherence to treatment in patients with cardiovascular diseases

Estimating time‐varying drug adherence using electronic records: extending the proportion of days covered (PDC) method

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