Electronic Monitoring of Medication Adherence in a 1-year Clinical Study of 2 Dosing Regimens of Mesalazine for Adults in Remission with Ulcerative Colitis

Gillespie, David; Hood, Kerenza; Farewell, Daniel; Stenson, Rachel; Probert, Chris; Hawthorne, A. B.

doi:10.1097/01.mib.0000437500.60546.2a

Cited by 19 publications

(39 citation statements)

References 31 publications

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“…Of note, when a continuous outcome was used, a correlation approach was considered in 36 comparisons to assess agreement between measurement methods leading to an average correlation of 0.35, ranging from À0.67 to 0.76 [5,8,16,19,24,29,33,34,41,43,55,62,63,65,67,69,86,88,90,91]. For 31 of those correlations, the null hypothesis of no correlation was formally tested and rejected (P < 0.05) in 24 cases (77%) leading to the conclusion that there is a significant linear association between the measurement methods.…”

Section: Analysis Of Extracted Datamentioning

confidence: 99%

A scoping review of studies comparing the medication event monitoring system (MEMS) with alternative methods for measuring medication adherence

Alili

Vrijens

Demonceau

et al. 2016

Brit J Clinical Pharma

142

100

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Different methods are available for measuring medication adherence. In this paper, we conducted a scoping review to identify and summarize evidence of all studies comparing the Medication Event Monitoring System (MEMS) with alternative methods for measuring medication adherence. A literature search was performed using the open database www.iAdherence.org that includes all original studies reporting findings from the MEMS. Papers comparing methods for measuring adherence to solid oral formulations were included. Data was extracted using a standardized extraction table. A total of 117 articles fulfilled the inclusion criteria, including 251 comparisons. Most frequent comparisons were against self-report (n = 119) and pill count (n = 59). Similar outcome measures were used in 210 comparisons (84%), among which 78 used dichotomous variables (adherent or not) and 132 used continuous measures (adherence expressed as percentage). Furthermore, 32% of all comparisons did not estimate adherence over the same coverage period and 44% of all comparisons did not use a statistical method or used a suboptimal one. Only eighty-seven (35%) comparisons had similar coverage periods, similar outcome measures and optimal statistical methods. Compared to MEMS, median adherence was grossly overestimated by 17% using self-report, by 8% using pill count and by 6% using rating. In conclusion, among all comparisons of MEMS versus alternative methods for measuring adherence, only a few used adequate comparisons in terms of outcome measures, coverage periods and statistical method. Researchers should therefore use stronger methodological frameworks when comparing measurement methods and be aware that non-electronic measures could lead to overestimation of medication adherence.

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Section: Analysis Of Extracted Datamentioning

confidence: 99%

A scoping review of studies comparing the medication event monitoring system (MEMS) with alternative methods for measuring medication adherence

Alili

Vrijens

Demonceau

et al. 2016

Brit J Clinical Pharma

142

100

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“…This substudy demonstrated that adherence to study medication was generally lower and more varied for participants allocated to the TDS regimen. However, as this type of measure was not used for all trial participants, it will not be considered further in this paper [16]. …”

Section: Methodsmentioning

confidence: 99%

The use of randomisation-based efficacy estimators in non-inferiority trials

Gillespie

Farewell

Barrett-Lee

et al. 2017

Trials

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BackgroundIn a non-inferiority (NI) trial, analysis based on the intention-to-treat (ITT) principle is anti-conservative, so current guidelines recommend analysing on a per-protocol (PP) population in addition. However, PP analysis relies on the often implausible assumption of no confounders. Randomisation-based efficacy estimators (RBEEs) allow for treatment non-adherence while maintaining a comparison of randomised groups. Fischer et al. have developed an approach for estimating RBEEs in randomised trials with two active treatments, a common feature of NI trials. The aim of this paper was to demonstrate the use of RBEEs in NI trials using this approach, and to appraise the feasibility of these estimators as the primary analysis in NI trials.MethodsTwo NI trials were used. One comparing two different dosing regimens for the maintenance of remission in people with ulcerative colitis (CODA), and the other comparing an orally administered treatment to an intravenously administered treatment in preventing skeletal-related events in patients with bone metastases from breast cancer (ZICE). Variables that predicted adherence in each of the trial arms, and were also independent of outcome, were sought in each of the studies. Structural mean models (SMMs) were fitted that conditioned on these variables, and the point estimates and confidence intervals compared to that found in the corresponding ITT and PP analyses.ResultsIn the CODA study, no variables were found that differentially predicted treatment adherence while remaining independent of outcome. The SMM, using standard methodology, moved the point estimate closer to 0 (no difference between arms) compared to the ITT and PP analyses, but the confidence interval was still within the NI margin, indicating that the conclusions drawn would remain the same. In the ZICE study, cognitive functioning as measured by the corresponding domain of the QLQ-C30, and use of chemotherapy at baseline were both differentially associated with adherence while remaining independent of outcome. However, while the SMM again moved the point estimate closer to 0, the confidence interval was wide, overlapping with any NI margin that could be justified.ConclusionDeriving RBEEs in NI trials with two active treatments can provide a randomisation-respecting estimate of treatment efficacy that accounts for treatment adherence, is straightforward to implement, but requires thorough planning during the design stage of the study to ensure that strong baseline predictors of treatment are captured. Extension of the approach to handle nonlinear outcome variables is also required.Trial registrationThe CODA study: ClinicalTrials.gov, identifier: NCT00708656. Registered on 8 April 2008. The ZICE study trial: ClinicalTrials.gov, identifier: NCT00326820. Registered on 16 May 2006.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1837-3) contains supplementary material, which is available to authorized users.

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“…Tablet count was defined as the number of tablets taken (not present in the container) expressed as the percentage of the correct number of tablets advised by the physician for the study period, that is, 90 tablets. 24 , 25 …”

Section: Methodsmentioning

confidence: 99%

Drug holidays: the most frequent type of noncompliance with calcium plus vitamin D supplementation in persistent patients with osteoporosis

Touskova¹,

Vytrisalova²,

Palička³

et al. 2015

PPA

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PurposeAll current recommendations include calcium and vitamin D (Ca–D) as an integrated part of osteoporosis treatment. The purpose of this pilot study was to analyze compliance with a fixed combination of Ca–D in women persistent with the treatment.Patients and methodsAn observational study was carried out in three osteocenters in the Czech Republic. Women with osteoporosis ≥55 years of age concurrently treated with oral ibandronate were eligible. Compliance was evaluated in a period of 3 months by Medication Event Monitoring System (MEMS), tablet count, and self-report. Nonpersistence was defined as a MEMS-based gap in the use of Ca–D to be 30 days or more.ResultsA total of 73 patients were monitored, of which 49 patients were analyzed (target population). Based on MEMS, mean overall compliance was 71%; good compliance (≥80%) was observed in 59% of the patients. As many as 71% of the patients took drug holidays (≥3 consecutive days without intake); overall compliance of these patients was 59% and was slightly lower on Fridays and weekends. Patients without drug holidays were fully compliant (did not omit individual doses). Compliance differed according to daily time at which the patients mostly used the Ca–D. Afternoon/evening takers showed a mean overall compliance of 82% while morning/night takers only 51% (P=0.049). Based on MEMS, tablet count, and self-report, compliance ≥75% was observed in 59%, 100%, and 87% of the patients, respectively. Outcomes obtained by the three methods were not associated with each other. Undesirable concurrent ingestion of Ca–D and ibandronate was present only twice.ConclusionDespite almost perfect self-reported and tablet count-based compliance, MEMS-based compliance was relatively poor. Consecutive supplementation-free days were common; more than two-thirds of the patients took at least one drug holiday. This pilot study showed drug holiday to be the most important type of noncompliance with Ca–D in those who are persistent with the treatment.

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Electronic Monitoring of Medication Adherence in a 1-year Clinical Study of 2 Dosing Regimens of Mesalazine for Adults in Remission with Ulcerative Colitis

Cited by 19 publications

References 31 publications

A scoping review of studies comparing the medication event monitoring system (MEMS) with alternative methods for measuring medication adherence

A scoping review of studies comparing the medication event monitoring system (MEMS) with alternative methods for measuring medication adherence

The use of randomisation-based efficacy estimators in non-inferiority trials

Drug holidays: the most frequent type of noncompliance with calcium plus vitamin D supplementation in persistent patients with osteoporosis

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