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Use of Electronic Monitoring in Clinical Nursing Research
Abstract
In the past decade, the introduction of electronic monitoring systems for monitoring medication adherence has contributed to the dialog about what works and what does not work in monitoring adherence. The purpose of this article is to describe the use of the Medication Event Monitoring System (MEMS) in a study of patients receiving isoniazid for latent tuberculosis infection. Three case examples from the study illustrate the data that are obtained from the electronic device compared to self-reports and point to the disparities that may occur in electronic monitoring. The strengths and limitations of using the MEMS and ethical issues in utilizing this technology are discussed. Nurses need to be aware of these challenges when using electronic measuring devices to monitor medication adherence in clinical nursing practice and research.
... Monitoring Systems to measure medication adherence (55). This device is used to monitor medication adherence through a cap that fits on a standard medication bottle and records the date and time when it is opened (55). ...
... Monitoring Systems to measure medication adherence (55). This device is used to monitor medication adherence through a cap that fits on a standard medication bottle and records the date and time when it is opened (55). The automated timing and dosing history provide a characterization of patients' medication adherence and a clear distinction between initiation and interruption (55). ...
... This device is used to monitor medication adherence through a cap that fits on a standard medication bottle and records the date and time when it is opened (55). The automated timing and dosing history provide a characterization of patients' medication adherence and a clear distinction between initiation and interruption (55). When 11 articles were analyzed, median adherence was overestimated in selfreports compared to MEMS, 8% using pill count and 6% using rating (54). ...
Introduction: The number of medicines prescribed to a patient can be an obstacle to medicine adherence. CLEAN Meds randomized clinical trial aimed to determine the provision of essential medicines at no charge. Providing free medicines improved adherence. However, free medicine provision, might have different effects depending on the number of medicines prescribed to a patient. Objective: To determine whether the number of prescribed medicines modifies the beneficial effect of free medicine distribution.
Methods: Using binary logistic regression, the analysis determines whether the number of medications modified the intervention of free medicine distribution while correcting for confounders. Results: While providing medicines free of charge improves adherence (P= 0.02), this effect was not modified by the number of medicines prescribed (p = 0.52).
Conclusion: The beneficial effect of free medicine distribution does not depend on the number of medicines prescribed. These findings can help inform changes to medicine access policies in Canada.
... Self-report adherence, however, has been shown to overestimate adherence [15]. The use of medication event monitoring system (MEMS) caps, a relatively new innovation that records date and time that the cap of a pill bottle is removed as a surrogate for taking a dose of the medication inside, has revealed that patient self-report, as well as pill count, generally overestimate adherence [15,16]. This indirect approach currentlyprovides the most reliable data on adherence [17]. ...
... Adherence score was 50% according to the composite calculation method, whereas with the usual method, the adherence score was 97.5o/o d:urine the 6 and a composite adherence score that takes into account not only the number of doses per day but also the intake interval between 2 doses and between meals. Our observations with a mean adherence score of 95% with usual calculation or 83o/o with the composite index are consistent with scores of adherence to oral cancer therapies that have been documented to range between 16 and 100% in the adult population (for review see [l]). ...
Purpose:
Patient nonadherence to oral antineoplastic therapy is a well-recognized barrier to effective treatment. In order to identify patients who may need additional support to become adherent, it is important to have a useful tool that takes into account all the parameters of adherence to prescription. The aim of this prospective study was to evaluate adherence of oral antineoplastic agents and to investigate two calculation methods of adherence score.
Patients and methods:
Twenty-nine cancer patients were enrolled in this study. Fourteen were treated by capecitabine and 15 patients by aromatase inhibitors. Adherence was measured using a medication event monitoring system and adherence score was calculated by a usual method and a composite adherence score that takes into account missed doses and also intake interval errors (between 2 doses and between meals).
Results:
Across the 6-month evaluation period, average adherence was 95% with the standard calculation (capecitabine group: 89%; aromatase inhibitor group: 99%) versus 83% with the composite index (capecitabine group: 62%; aromatase inhibitor group: 99%) (p = 0.030). The composite calculation permits to highlight more nonadherent patients (29.6 vs. 7.4%), particularly in the capecitabine group (73 vs. 18%, p = 0.001). We report 2 cases identified as nonadherent with composite adherence rate.
Conclusion:
The composite adherence score permits to better evaluate adherence to prescription and to identify barriers to adherence and persistence.
... First, adherence is notoriously challenging to measure. Although EDM adherence data are often considered the gold standard, the technique has drawbacks that include participant resistance and misuse or misunderstanding, which may result in overestimates of low adherence [42]. Some researchers have speculated that using EDM devices may alter adherence behavior, since participants are aware that it is being tracked, and some may already have a pill-taking routine that is disrupted by using a new device [27,42]. ...
... Although EDM adherence data are often considered the gold standard, the technique has drawbacks that include participant resistance and misuse or misunderstanding, which may result in overestimates of low adherence [42]. Some researchers have speculated that using EDM devices may alter adherence behavior, since participants are aware that it is being tracked, and some may already have a pill-taking routine that is disrupted by using a new device [27,42]. Furthermore, self-reported adherence also is subject to limitations, including general overestimation of adherence, retrospective biases, and inaccuracy, and may be especially inaccurate among participants reporting perfect adherence [43,44]. ...
Antiretroviral therapy (ART) greatly reduces morbidity and mortality for people with HIV/AIDS. However, for optimal effectiveness patients must achieve strict adherence to dosing regimens, which is difficult to maintain over the long term. Interventions to improve adherence have shown promising results, but with small effects. One explanation for small overall effects is that some patient subgroups are less able to benefit from current interventions; however, this explanation lacks empirical support. This study used multilevel modeling of data from a randomized controlled trial in an exploratory analysis to assess whether patient factors moderated the impact of peer support and pager reminders on ART adherence and biological markers of HIV. According to 272 interaction models using an alpha-corrected significance criteria, none of 34 patient characteristics significantly moderated either intervention. Findings suggest that intervention research might more profitably focus on other ways of improving effects, like individual patient needs, rather than target subgroups.
... In the studies included in this review, MEMS and clinical cure were indirect methods that were always used together with other methods (Rocha, 2008;Steury, 2016). Electronic pillboxes are capable of recording the date and time when the bottle was opened, making it possible to recognize patterns of medication use such as only opening the pillbox before the follow-up visits ("White Coat Adherence") (Schwed et al., 1999;Ailinger et al., 2008). However, pillbox opening does not guarantee ingestion of the pills and, just as failure to open the pillbox does not mean the pills are not being taken. ...
Malaria is a curable disease for which early diagnosis and treatment, together with the elimination of vectors, are the principal control tools. Non-adherence to antimalarial treatment may contribute to therapeutic failure, development of antimalarial resistance, introduction or resurgence of malaria in non-endemic areas, and increased healthcare costs. The literature describes several methods to directly or indirectly assess adherence to treatment, but no gold standard exists. The main purpose of this review is to systematize the methods used to assess patient adherence to antimalarial treatment. A systematic review was performed, in accordance with the PRISMA statement, of the following databases: LILACS, EMBASE, PUBMED, COCHRANE, GOOGLE SCHOLAR, WEB OF SCIENCE, SCOPUS, and OPENGREY, through 14 December 2021. A snowball search was also performed by screening the references of the included studies as well as those cited in relevant reviews. Inclusion criteria were reporting assessment of the patient’s adherence to antimalarials in individuals with laboratory diagnosis of malaria, the description of antimalarials prescribed, and adherence estimates. Exclusion criteria were studies exclusively about directly observed therapy, studies of populations ≤12 yo and guidelines, commentaries, reviews, letters, or editorials. Study quality was assessed using MINORS and the Cochrane Risk of Bias Tool. Proportions were calculated to measure frequencies considering the number of articles as the denominator. Twenty-one studies were included in this review. Most of them (76.5%) assessed adherence to falciparum malaria treatment. Seventeen studies (80.9%) used a combination of methods. The methods described were pill counts, self-reports, biological assays, use of electronic pillboxes, and clinical cure. It was possible to identify different adherence classifications for all the methods used. Our review found that indirect methods like pill counts and self-reports are the most commonly used. Combining an method that gives solid proof of the ingestion of medication and a method that completes the research with information regarding factors, beliefs or barrier of adherence seems to be the best approach. Future studies of antimalarial treatment should standardize adherence classifications, and collect data on the types and causes of nonadherence, which can contribute to the development of tools to promote medication adherence. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020148054, identifier CRD42020148054
... The medication event monitoring of medication implementation adherence was conducted with the MEMS Smart Cap (AARDEX Group). The MEMS cap includes an electronic chip that digitally records the time when pill bottles are opened and thus indirectly measures the time when a medication is being dispensed [30]. The participants' Google Assistant profiles were reviewed to ensure that daily reminders for the scheduled medication doses were executed on time. ...
Background:
Pain is difficult to manage in older adults. It has been recommended that pain management in older adults should include both nonpharmacologic and pharmacologic strategies. Unfortunately, nonadherence to pain medication is more prevalent than nonadherence to any other chronic disease treatment. Technology-based reminders have some benefit for medication adherence, but adherence behavior outcomes have mostly been verified by self-reports.
Objective:
We aimed to describe objective medication adherence and the latency of medication use after a voice assistant reminder prompted participants to take pain medications for chronic pain.
Methods:
A total of 15 older adults created a voice assistant reminder for taking scheduled pain medications. A subsample of 5 participants were randomly selected to participate in a feasibility study, in which a medication event monitoring system for pain medications was used to validate medication adherence as a health outcome. Data on the subsample's self-assessed pain intensity, pain interference, concerns and necessity beliefs about pain medications, self-confidence in managing pain, and medication implementation adherence were analyzed.
Results:
In the 5 participants who used the medication event monitoring system, the overall latency between voice assistant reminder deployment and the medication event (ie, medication bottle cap opening) was 55 minutes. The absolute latency (before or after the reminder) varied among the participants. The shortest average time taken to open the cap after the reminder was 17 minutes, and the longest was 4.5 hours. Of the 168 voice assistant reminders for scheduled pain medications, 25 (14.6%) resulted in the opening of MEMS caps within 5 minutes of the reminder, and 107 (63.7%) resulted in the opening of MEMS caps within 30 minutes of the reminder.
Conclusions:
Voice assistant reminders may help cue patients to take scheduled medications, but the timing of medication use may vary. The timing of medication use may influence treatment effectiveness. Tracking the absolute latency time of medication use may be a helpful method for assessing medication adherence. Medication event monitoring may provide additional insight into medication implementation adherence during the implementation of mobile health interventions.
... Second, we relied on participants to indicate the time when they collected saliva samples, as opposed to using MEMS Caps or other electronic devices to record collection time. However, methods to electronically record times when containers holding saliva collection supplies (or medications) are opened and have also been found to suffer from limitations (Ailinger et al., 2008;Hall et al., 2011). Third, the sample used in this pilot included survivors with different cancer treatment histories, and informal caregivers of varying ages and sex. ...
Introduction: To date, no study has explored associations between objective stress-related biomarkers (i.e., inflammatory markers, diurnal rhythm of cortisol) and health-related quality of life (HRQOL) in Latina breast cancer survivors and their informal caregivers (i.e., family, friends). Method: This cross-sectional feasibility study assessed saliva C-reactive protein, saliva diurnal cortisol rhythm (cortisol slope), and self-reported HRQOL (psychological, physical, and social domains) in 22 Latina survivor–caregiver dyads. Feasibility was defined as ≥85% samples collected over 2 days (on waking, in afternoon, and in evening). Associations between biomarkers and HRQOL were examined with correlational analyses. Results: Collection of saliva was feasible. Strongest associations were observed between survivor evening cortisol (as well as cortisol slope) and fatigue, a component of physical HRQOL. Discussion: Associations presented may help promote investigations of mechanisms linking stress-related biomarkers and HRQOL in Latina breast cancer survivor–caregiver dyads, which will facilitate development of culturally congruent interventions for this underserved group.
... Once EAMDs with acceptable accuracy have been identified, differences in EAMD design (e.g., pill boxes versus bottles), medication capacity, data storage capacity, battery life, data transmission capabilities, on-board reminder features, interface with other products or services (e.g., mobile applications), and cost can be reviewed. 9,[25][26][27] We encourage researchers to obtain this information from multiple sources including: EAMD manufacturerprovided materials, discussions with manufacturer representatives, and/or consultations with researchers with experience using the EAMD. A framework for considering the impact of these features on EAMD performance is detailed by de Bleser et al. 20 Particularly when EAMD features (e.g., real-time remote data transmission) are essential for the study aims or feasibility, pilot field testing is recommended prior to finalizing EAMD selection (see examples 23, 28-31 ). ...
While electronic adherence monitoring devices (EAMDs) are the preferred and most objective medication adherence measurement strategy for many populations and research questions, there is no comprehensive methodological framework for EAMD use. We synthesize recommendations from experts in adherence science and the scientific literature to create a temporal framework of EAMD research methods. The goal of this framework is to provide a step-by-step guide that will enable researchers to design, prepare, implement, and clean data from rigorous, high-quality studies using EAMDs to assess adherence. Resources including a checklist of methodological considerations and example protocols have been created to assist readers in using this framework.
... Further enquiry of the kind we have carried out is necessary among groups of patients whose circumstances further compromise opportunities for adherence [26]. In addition, given the relatively small sample size, the findings may not be representative of how all drug-susceptible pulmonary TB patients use the MERM device, nor is the inconsistent predictive validity of digital dosing histories an original finding [7,9,27]. ...
Background:
Despite the criticality of adherence to tuberculosis treatment, there is paucity of rigorous experimental research exploring the efficacy of interventions to promote adherence and a greater lack of inquiry addressing the integral role of adherence behaviour. The aim of this formative study was to examine the way in which the Wisepill evriMED Medication Event Reminder Monitor (MERM) was used among outpatients with drug susceptible pulmonary tuberculosis.
Methods:
In depth interviews were conducted with 20 outpatients receiving treatment from two public healthcare facilities in Thanh Hoa, a rural province in northern Viet Nam. Patients had been enrolled in a randomized controlled trial evaluating the effect of using the MERM device upon adherence for between 1-3 months. The control group used the device without an alert, while the intervention group used the device with a daily alert and scheduled dosing history review.
Findings:
All 20 patients interviewed were supportive of using the MERM device. Those able to be at home at the time that their treatment was due (50%) used the device as intended. Patients who worked all reported separating the time when the box was opened from the time at which they ingested their medication. Patients expressed fidelity to the prescribed medication taking time and concerns regarding the portability of the device. Limitations of the study surround the inclusion of a small sample population that did not experience factors that further compromise adherence.
Conclusions:
Data recorded by the box did not always accurately reflect usage patterns. The alert in the intervention arm was able to support adherence only in patients who did not work while completing their treatment. MERM implementation can be improved by better aligning prescriber instructions with patients' daily routines, and increasing the use of adherence data to guide adherence support practices. Healthcare staff need to be aware of potential barriers to optimal use of MERM devices. A rigorous qualitative approach to formative assessment is essential to inform the scale up of new digital technologies.
... It consists of a computer chip in the bottle cap, which records the date and time each time the pill bottle is opened. 41,42 Moreover, MedSignals ® (MedSignals/VitalSignals LLC, Lexington, KY, USA) is an electronic pill box which aids in the management of medication intake by providing real-time feedback on the patients adherence. 41 Examples of inhaled medication monitors consist of the DOSER (MediTrack Products LLC, South Easton, MA, USA), Medtrack metered-dose inhaler (MDI) Chronolog, MDILog (Westmed, Inc., Tucson, AZ, USA) and the Smartinhaler Tracker (Adherium Ltd, Auckland, New Zealand). ...
Nonadherence in children who use long-term medication is a serious problem and assessing adherence is an important step to provide solutions to this problem. Medication adherence can be measured by several methods, including (a) self-report questionnaires or structured interviews, (b) therapeutic drug monitoring (TDM), (c) electronic devices, and (d) pick-up/refill rates. The objective of this narrative review is to provide an overview of the literature about methods for the measurement of medication adherence in chronically ill children and adolescents. Therefore, we conducted a literature search by using multiple databases. Four methods of monitoring medication adherence are presented for the most described chronic diseases: asthma, HIV/AIDS, epilepsy, diabetes mellitus and ADHD. First, 10 commonly used self-report questionnaires and structured interviews are described, including the main characteristics, (dis)advantages and their validation studies. Second, the use of TDM in pediatric trials for medication adherence measurement is discussed. New sampling methods (e.g. dried blood spot) and sampling matrices (e.g. hair, saliva and urine) have shown their benefits for TDM in children. Third, electronic devices to measure medication adherence in children are presented, being developed for several drug administration routes. Fourth, the analyses, advantages and disadvantages of pharmacy data are discussed. The usage of this data requires specific calculations and interpretations to assess adherence. As presented in this review, every adherence method has specific (dis)advantages. When deciding which adherence method is applicable, validity and generalizability should be taken into account. Combining multiple methods seems to offer the best solution in the daily clinical practice.
... These gaps in coverage are compared to the length of time a person is observed to account for the proportion of days covered on treatment. Although the PDC has been validated against other commonly used measures of medication adherence such as patient self-report and medication electronic monitoring systems (MEMS) [21,22], they do not measure actual consumption of medication by patients and are imperfect metrics of actual adherence. ...
Adherence to renin angiotensin system antagonists (RASA), non-insulin diabetes medications (NIDM) and statins has been included in the Medicare Star Ratings program since 2012. The long-term use of these measures emphasizes adherence to a limited number of chronic medications and may present opportunities for Part D plan sponsors to misuse the measures to influence their Medicare Part D Star Rating. It also does not capture the adherence needs of high-risk patients with multiple chronic conditions. The objective of this study was to describe the development of a new measure to capture adherence to multiple medications for chronic conditions (MMCC). The MMCC measure captures adherence to 71 different therapeutic categories of medication and was constructed using North Carolina Medicaid prescription claims data from 2015 to 2017. This measure was validated against the existing RASA, NIDM and statin adherence measures. This new measure was highly correlated with Star Rating measures, captured a greater number of eligible patients than these existing measures and had a lower proportion of patients meet the adherence threshold than the existing Star Ratings adherence measures. There is an opportunity to develop new measures, which include adherence to multiple medications in populations with multiple chronic conditions.
... • Configuration management and reconfigurable manufacturing systems for the development of microsystems during lifecycle[65]. • Ethics: ethical issues in the activities of criteria-based decision making autonomous micro-manipulators in the medical, biological, aerospace and industrial fields[66][67][68][69][70]. ...
Manipulating micro objects has become an important task in several applications. Actuation is a crucial aspect of micromanipulation because there are physical restrictions which affect actuators’ performances at the micro or nano scale. One way of getting rid of these limitations is the use of an appropriate mechanical structure which enhances the elasticity of the material or provides mechanical advantage. This Special Issue of Actuators, which is dedicated to micromanipulation, offers a contribution to the development of some promising methods to actuate a microsystem for micromanipulation.
... Prior studies have assessed AET adherence using selfreport measures, which may limit the validity of the adherence data [113,114]. While Medication Event Monitoring Systems (MEMs) are frequently used as an objective measure of adherence, data obtained from these devices must be downloaded in-person and then examined on a computer [115]. There is no way to obtain the data if the MEMs Cap is not returned. ...
Adjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). Adherence to AET will be assessed in real-time for 18 months using wireless smart pill bottles. Symptom interference (i.e., pain, vasomotor symptoms, sleep problems, vaginal dryness) and cost-effectiveness of the intervention protocol will be examined as secondary outcomes. Participants (N = 400) will be recruited from a tertiary care medical center or community clinics in medically underserved or rural areas. Participants will be randomized to receive CST-AET or a general health education intervention (comparison condition). CST-AET includes ten nurse-delivered calls delivered over 6 months. CST-AET provides systematic training in coping skills for managing symptoms that interfere with adherence. Interactive voice messaging provides reinforcement for skills use and adherence that is tailored based on real-time adherence data from the wireless smart pill bottles. Given the high rates of non-adherence and recent recommendations that women remain on AET for 10 years, we describe a timely trial. If effective, the CST-AET protocol may not only reduce the burden of AET use but also lead to cost-effective changes in clinical care and improve breast cancer outcomes. Trials registration: ClinicalTrials.gov, NCT02707471, registered 3/3/2016.
... estudo apresentou limites em relação à perda amostral durante os dois meses do estudo, principalmente quanto ao uso dos frascos de monitoramento eletrônico. Parte dos abandonos podem também estar relacionadas a dificuldades no uso dos MEMS, já relatadas previamente na literatura24 . Em futuros estudos, o treinamento prévio dos participantes para facilitar a manipulação dos frascos poderia minimizar o número de perdas. ...
... estudo apresentou limites em relação à perda amostral durante os dois meses do estudo, principalmente quanto ao uso dos frascos de monitoramento eletrônico. Parte dos abandonos podem também estar relacionadas a dificuldades no uso dos MEMS, já relatadas previamente na literatura24 . Em futuros estudos, o treinamento prévio dos participantes para facilitar a manipulação dos frascos poderia minimizar o número de perdas. ...
OBJECTIVE
To present the development and validation of the WebAd-Q Questionnaire, a self-report instrument to monitor adherence to antiretroviral therapy in HIV/AIDS centers in Brazil.
METHODS
The WebAd-Q is an electronic questionnaire that has three questions about the use of antiretrovirals in the last week. It was constructed from interviews and focus groups with 38 patients. Its validity was tested in a study with a sample of 90 adult patients on antiretroviral therapy for at least three months. We used electronic monitoring bottles, pill counting, and self-report interview to compare adherence. The WebAd-Q was answered on the sixtieth day, twice, with at least one hour of interval. The viral load of the patients was obtained from the service records. We have analyzed the agreement between the answers to the WebAd-Q, the associations, and the correlations with viral load and performance compared to other measures of adherence.
RESULTS
Among the invited patients, 74 (82.2%) answered the WebAd-Q. No difficulties were reported to answer the questionnaire. The average answer time was 5 min 47 sec. The set of three questions of the WebAd-Q obtained agreement of 89.8%, with Kappa of 0.77 (95%CI 0.61–0.94). The non-adherence answers of the WebAd-Q were associated with detectable viral load. We obtained moderate viral load correlations with the non-adherence scale according to the WebAd-Q. For the three questions of the WebAd-Q, patients with non-adherence answers were also reported as less adherent according to the other measures of adherence.
CONCLUSIONS
The WebAd-Q answered all the issues considered relevant in the validation of questionnaires, was well understood by patients, was associated with viral load, and obtained good agreement and good performance compared to the other measures. The feasibility analysis of its implementation still depends on a national study on its applicability.
... 11 eMEMS, on the other hand, can underestimate adherence when several doses of medications are removed from bottles at a single time, as was observed in the present and other studies. 12,13 Similar to what was observed in our cohort, self-reported rates of adherence are higher than the rates derived from electronic monitoring; however, the 40% -50% difference between the two measures is greater than the 10% -30% reported in other settings. 14,15 This result may be owing to limited validity of the eMEMS data, given the numerous challenges when implementing eMEMS into routine care in a resource-limited setting, including batteries of eMEMS caps running flat, power cuts during the transfer of eMEMS data to computer, errors made by pharmacists when filling the containers, and breakage of the container lids. ...
Background
Healthcare workers are often reluctant to start combination antiretroviral therapy (ART) in patients receiving tuberculosis (TB) treatment because of the fear of high pill burden, immune reconstitution inflammatory syndrome, and side-effects.
Object
To quantify changes in adherence to tuberculosis treatment following ART initiation.
Design
A prospective observational cohort study of ART-naïve individuals with baseline CD4 count between 50 cells/mm³ and 350 cells/mm³ at start of TB treatment at a primary care clinic in Johannesburg, South Africa. Adherence to TB treatment was measured by pill count, self-report, and electronic Medication Event Monitoring System (eMEMS) before and after initiation of ART.
Results
ART tended to negatively affect adherence to TB treatment, with an 8% – 10% decrease in the proportion of patients adherent according to pill count and an 18% – 22% decrease in the proportion of patients adherent according to eMEMS in the first month following ART initiation, independent of the cut-off used to define adherence (90%, 95% or 100%). Reasons for non-adherence were multifactorial, and employment was the only predictor for optimal adherence (adjusted odds ratio 4.11, 95% confidence interval 1.06–16.0).
Conclusion
Adherence support in the period immediately following ART initiation could optimise treatment outcomes for people living with TB and HIV.
... Considering the low number of studies that used objective methods, no firm conclusions can be drawn with respect to objective self-care. Critically, objective measures are also complicated by several practical (e.g., high costs, technical and logistic problems) and methodological limitations (94). For instance, The Medication Event Monitoring System registers when the bottle is opened, but this does not ensure that medication is actually taken. ...
Objective:
Psychological distress has been associated with poor outcomes in patients with chronic heart failure (HF), which is assumed to be partly due to poor HF self-care behavior. This systematic review and meta-analysis describes the current evidence concerning psychological determinants of self-care in patients with chronic HF.
Methods:
Eligible studies were systematically identified by searching electronic databases PubMed, PsycINFO, and the Conference Proceedings Citation Index (Web of Science) for relevant literature (1980-October 17, 2014). Study quality was assessed according to the level of risk of bias. Quantitative data were pooled using random-effects models.
Results:
Sixty-five studies were identified for inclusion that varied considerably with respect to sample and study characteristics. Risk of bias was high in the reviewed studies and most problematic with regard to selection bias (67%). Depression (r = -0.19, p < .001), self-efficacy (r = 0.37, p < .001), and mental well-being (r = 0.14, p = .030) were significantly associated with self-reported self-care. Anxiety was not significantly associated with either self-reported (r = -0.18, p = .24) or objective self-care (r = -0.04, p = .79), neither was depression associated with objectively measured medication adherence (r = -0.05, p = .44).
Conclusions:
Psychological factors (depression, self-efficacy, and mental well-being) were associated with specific self-care facets in patients with chronic HF. These associations were predominantly observed with self-reported indices of self-care and not objective indices. Methodological heterogeneity and limitations preclude definite conclusions about the association between psychological factors and self-care and should be addressed in future research.
... All of these studies were conducted in developing countries or in resource limited settings, which could be a contributing factor to the use of self-report rather than "gold standard" methods such as MEMS caps or pharmacy refill data. Usage of MEMS caps in resource limited settings is most likely constrained due to their high costs (approximately $100 USD per cap) [35][36][37] . Only 1 study in our review included the use of MEMS caps, in a region where the gross national income per capita is $1483 USD, which is the lowest in the world [38] . ...
Aim:
To review methods of assessing adherence and strategies to improve adherence to cardiovascular disease (CVD) medications, among South Asian CVD patients.
Methods:
We conducted a systematic review of English language studies that examined CVD medication adherence in South Asian populations from 1966 to April 1, 2015 in SCOPUS and PubMed. Working in duplicate, we identified 61 studies. After exclusions, 26 studies were selected for full text review. Of these, 17 studies were included in the final review. We abstracted data on several factors including study design, study population, method of assessing adherence and adherence rate.
Results:
These studies were conducted in India (n = 11), Pakistan (n = 3), Bangladesh (n = 1), Nepal (n = 1) and Sri Lanka (n = 1). Adherence rates ranged from 32%-95% across studies. Of the 17 total publications included, 10 focused on assessing adherence to CVD medications and 7 focused on assessing the impact of interventions on medication adherence. The validated Morisky Medication Adherence Scale (MMAS) was used as the primary method of assessing adherence in five studies. Three studies used validated questionnaires similar to the MMAS, and one study utilized Medication Event Monitoring System caps, with the remainder of the studies utilizing pill count and self-report measures. As expected, studies using non-validated self-report measures described higher rates of adherence than studies using validated scale measurements and pill count. The included intervention studies examined the use of polypill therapy, provider education and patient counseling to improve medication adherence.
Conclusion:
The overall medication adherence rates were low in the region, which suggest a growing need for future interventions to improve adherence.
... 11 eMEMS, on the other hand, can underestimate adherence when several doses of medications are removed from bottles at a single time, as was observed in the present and other studies. 12,13 Similar to what was observed in our cohort, self-reported rates of adherence are higher than the rates derived from electronic monitoring; however, the 40% -50% difference between the two measures is greater than the 10% -30% reported in other settings. 14,15 This result may be owing to limited validity of the eMEMS data, given the numerous challenges when implementing eMEMS into routine care in a resource-limited setting, including batteries of eMEMS caps running flat, power cuts during the transfer of eMEMS data to computer, errors made by pharmacists when filling the containers, and breakage of the container lids. ...
Background: Healthcare workers are often reluctant to start combination antiretroviral therapy (ART) in patients receiving tuberculosis (TB) treatment because of the fear of high pill burden, immune reconstitution inflammatory syndrome, and side-effects. Object: To quantify changes in adherence to tuberculosis treatment following ART initiation. Design: A prospective observational cohort study of ART-naive individuals with baseline CD4 count between 50 cells/mm(3) and 350 cells/mm(3) at start of TB treatment at a primary care clinic in Johannesburg, South Africa. Adherence to TB treatment was measured by pill count, self-report, and electronic Medication Event Monitoring System (eMEMS) before and after initiation of ART. Results: ART tended to negatively affect adherence to TB treatment, with an 8% - 10% decrease in the proportion of patients adherent according to pill count and an 18% - 22% decrease in the proportion of patients adherent according to eMEMS in the first month following ART initiation, independent of the cut-off used to define adherence (90%, 95% or 100%). Reasons for non-adherence were multifactorial, and employment was the only predictor for optimal adherence (adjusted odds ratio 4.11, 95% confidence interval 1.06-16.0). Conclusion: Adherence support in the period immediately following ART initiation could optimise treatment outcomes for people living with TB and HIV.
... Electronic monitoring is recommended for objective assessment [77]; MEMS has been used in past schizophrenia studies with success [78]. We follow published guidelines for training patients to use MEMS and for analyzing data ( [79,80]). Patients are instructed to bring their prescribed antipsychotic medication to our clinic and are trained by study staff to use MEMS at the start of the study. The research assistant demonstrates the use of MEMS in front of the patient and answers any questions the patient may have. ...
Severe mental illnesses, including schizophrenia and other psychotic-spectrum disorders, are a major cause of disability worldwide. Although efficacious pharmacological and psychosocial interventions have been developed for treating patients with schizophrenia, relapse rates are high and long-term recovery remains elusive for many individuals. Furthermore, little is still known about the underlying mechanisms of these illnesses. Thus, there is an urgent need to better understand the contextual factors that contribute to psychosis so that they can be better targeted in future interventions. Ecological Momentary Assessment (EMA) is a dynamic procedure that permits the measurement of variables in natural settings in real-time through the use of brief assessments delivered via mobile electronic devices (i.e., smart phones). One advantage of EMA is that it is less subject to retrospective memory biases and highly sensitive to fluctuating environmental factors. In the current article, we describe the research-to-date using EMA to better understand fluctuating symptoms and functioning in patients with schizophrenia and other psychotic disorders and potential applications to treatment. In addition, we describe a novel EMA protocol that we have been employing to study the outcomes of patients with schizophrenia following a hospital discharge. We also report the lessons we have learned thus far using EMA methods in this challenging clinical population.
... Multiple published reviews compare EMD data to other forms of adherence measurement [31,34,42,45]. Studies support the notion that EMD data correlate with PCs, pharmacy refill and self report. ...
A decade after widespread recognition that adherence to medication regimens is key to antiretroviral effectiveness, considerable controversy remains regarding a "gold standard" for adherence measurement. Each adherence measurement approach has strengths and weaknesses and each rests on specific assumptions. The range of assumptions regarding adherence measurement and the diversity with which each approach is implemented strongly suggest that the evaluation of a particular measure outside of the context in which it was used (e.g. the study's operational protocol) may result in undeserved confidence or lack of confidence in study results. The purpose of this paper is to propose a set of best practices across commonly used measurement methods. Recommendations regarding what information should be included in published reports regarding how adherence was measured are provided to promote improvement in the quality of measurement of medication adherence in research.
... [15][16][17] Few studies report on the use of MEMS to monitor adherence to tuberculosis treatment. [18][19][20][21] Because of the high cost involved, MEMS is not feasible for use in routine practice in most settings with a high tuberculosis burden but could be used as a reference standard to validate simple and affordable measures that can be used in patients on community-based DOT. 8,21 In this pilot study, we used MEMS to: (i) describe adherence rates among Tanzanian tuberculosis patients on community-based DOT and (ii) determine the validity of several direct and indirect adherence measures of potential use in resource-limited settings. ...
To assess adherence to community-based directly observed treatment (DOT) among Tanzanian tuberculosis patients using the Medication Event Monitoring System (MEMS) and to validate alternative adherence measures for resource-limited settings using MEMS as a gold standard.
This was a longitudinal pilot study of 50 patients recruited consecutively from one rural hospital, one urban hospital and two urban health centres. Treatment adherence was monitored with MEMS and the validity of the following adherence measures was assessed: isoniazid urine test, urine colour test, Morisky scale, Brief Medication Questionnaire, adapted AIDS Clinical Trials Group (ACTG) adherence questionnaire, pill counts and medication refill visits.
The mean adherence rate in the study population was 96.3% (standard deviation, SD: 7.7). Adherence was less than 100% in 70% of the patients, less than 95% in 21% of them, and less than 80% in 2%. The ACTG adherence questionnaire and urine colour test had the highest sensitivities but lowest specificities. The Morisky scale and refill visits had the highest specificities but lowest sensitivities. Pill counts and refill visits combined, used in routine practice, yielded moderate sensitivity and specificity, but sensitivity improved when the ACTG adherence questionnaire was added.
Patients on community-based DOT showed good adherence in this study. The combination of pill counts, refill visits and the ACTG adherence questionnaire could be used to monitor adherence in settings where MEMS is not affordable. The findings with regard to adherence and to the validity of simple adherence measures should be confirmed in larger populations with wider variability in adherence rates.
... Within our sample, MEMS data suggested that many subjects withdrew all straws at the beginning of data collection or on a daily basis, resulting in numerous missing data points. Other studies investigating adherence have also reported missing data resulting from MEMS use (Ailinger et al., 2008;Llabre et al., 2006;Samet et al., 2001). Thus self-report of times for salivary collections were used in these analyses. ...
Cortisol, a stress-related hormone, has been measured in many psychoimmunological studies via collection of saliva; however, patterns of participant adherence to protocol procedures are rarely described in the literature.
In this paper we examine adherence to a cortisol morning rise collection protocol and explore its associations with demographic predictors and fatigue.
Participants included 262 breast cancer survivors enrolled in a National Institute of Nursing Research funded longitudinal intervention study (5R01NR010190, M. Mishel, P.I.). Self-reported times of salivary cortisol collection were recorded for each of 12 saliva samples. Adherence was assessed with respect to various demographic factors and fatigue. Participants were categorized as having high, moderate, or low adherence to the saliva collection protocol.
Overall, 117 (45%) participants had high adherence to the protocol, 117 (45%) participants had moderate adherence, and 28 (∼11%) participants had low adherence. Tests for proportionality for the polytomous logistic regression indicated that demographic predictors in our model had a similar association with each level of participant adherence. Women who did not adhere to the saliva collection were more likely to be African American (OR .50, CI .29-.88) and to report a high impact of fatigue on their behaviors (OR .88, CI .79-.98). Though other predictors in the model were not statistically significant (working full-time and living with at least one child under 18 years of age), the overall model was significant (χ(2)(4)=17.35, p<.01).
To our knowledge, this is the first study to examine profiles of participant adherence to a cortisol sampling protocol over multiple timepoints. By conceptualizing adherence as a polytomous outcome, future studies may give us insights into adherence trends in other populations with the aim of promoting adherence and designing more informed saliva collection protocols.
... 3,4 The use of microelectronic monitoring system (MEMS) caps, a relatively new innovation that records date and time that the cap of a pill bottle is removed as a surrogate for taking a dose of the medication inside, has revealed that patient self-report, as well as pill count, generally overestimate adherence. 3,[5][6][7] Valid assessment of patient adherence, the extent to which a patient acts in accordance with the prescribed interval and dose of a regimen, is critical in evaluating the effectiveness of an oral therapy. 8 In cancer, as with other diseases, there may be substantial variability in adherence to prescribed oral drug regimens, including taking fewer or more doses than prescribed or variation in timing of doses from day-to-day. ...
Patient adherence is critical in evaluating the effectiveness of an oral therapy. We sought to measure adherence among women randomly assigned to capecitabine in a preplanned substudy of a multicenter clinical trial.
Cancer and Leukemia Group B study CALGB 49907 was a randomly assigned trial comparing standard chemotherapy versus oral chemotherapy with capecitabine in patients age 65 years or older with early-stage breast cancer. We used microelectronic monitoring system (MEMS) caps on participants' capecitabine bottles to record pill bottle openings. Capecitabine was given in two divided daily doses for 14 consecutive days of a 21-day cycle for six cycles. Adherence was calculated as the number of doses taken divided by doses expected, taking into account toxicity-related dosing changes. A participant was defined as adherent if 80% or more of expected doses were recorded by MEMS.
Overall, 161 patients were enrolled. Median age was 71 years (range, 65 to 89 years); 124 patients (83%) persisted with capecitabine to completion of planned protocol therapy. Adherence was 78% across all cycles, and adherence did not vary by cycle (P = .32). Twenty-five percent of participants took fewer than 80% of expected doses and were nonadherent. In a logistic regression model, participants with node-negative disease (P = .01) and mastectomy (P = .01) were more likely to be nonadherent. Adherence was not related to age, tumor stage, or hormone receptor status. Adherence was not significantly associated with relapse-free survival or grade 3 or 4 toxicity.
Most older women with early-stage breast cancer were adherent to short-term oral chemotherapy in a randomized clinical trial. Age was not associated with adherence.
... In many diseases, pharmacy refill data is reviewed, sometimes covertly, where adherence is of concern in individual patients but we are not aware of this being undertaken routinely in whole clinics. Attempts at assessing and improving adherence in selected patients to treatments in an HIV or TB setting using electronic pillboxes have also been described [12,13]. Most of these studies involve either isolated measurements or short-term assessments of adherence. ...
Adaptive aerosol delivery (AAD) nebuliser devices can reduce treatment times whilst enabling adherence to be monitored using inbuilt data logs. Using one such device, we have monitored nebulised antibiotic adherence in children with Cystic Fibrosis (CF).
In CF children infected with Pseudomonas aeruginosa, downloaded data from an AAD device was used to calculate morning, evening and overall monthly adherence to antibiotic therapy over a year.
Overall monthly adherence to nebulised antibiotic therapy in 28 children was maintained between 60 and 70% over the year. Considerable variation in adherence, both between and within patients, was evident (Mean [SD] coefficient of variation, 37[44]%). Evening adherence (75[37]%) was better than morning adherence (58[34]%: p=0.012). Treatment regimens were changed in 8/28 patients based on adherence data.
Routine adherence monitoring can be implemented in an outpatient setting. Using this type of information it is possible to identify which aspects of treatment can be improved and to work together with families to individualize treatments.
Background:
Unhealthy alcohol use is associated with increased progression to tuberculosis (TB) disease, but its effect on adherence to isoniazid (INH) preventive therapy (IPT) is not known.
Methods:
This was a prospective study of persons with HIV (PWH) with latent TB in Southwestern Uganda reporting any current (prior 3 months) alcohol use or no alcohol consumption in prior year (2:1 ratio). All received INH. We defined sub-optimal adherence as <90% of days with at least one Medication Event Monitoring System (MEMS) cap opening, over the prior 90 days. Alcohol use was categorized as: none: no self-report, and phosphatidylethanol (PEth) <8 ng/mL; moderate: Alcohol Use Disorders Identification Test - Consumption (AUDIT-C) 1-2 (women) or 1-3 (men), and/or PEth 8-<50 ng/mL; unhealthy: AUDIT-C ≥3 (women) or ≥4 (men), and/or PEth ≥50 ng/mL. We used generalized estimating equations logistic regression analyses to assess the association between the level of alcohol use and sub-optimal INH adherence.
Results:
Three hundred and two persons were enrolled; 279 were on INH for three or more months. The prevalence of sub-optimal INH adherence was 31.3% at 3 months and 43.9% at 6 months. The odds of sub-optimal INH adherence were higher for unhealthy (adjusted odds ratio [aOR] 2.78 (95% CI: 1.62-4.76) and moderate [aOR] 1.59 (95% CI: 0.94-2.71) compared to no alcohol consumption.
Conclusions:
Sub-optimal adherence to INH at 3- and 6-months was high among PWH and associated with unhealthy alcohol use. Adherence support and/or alcohol reduction strategies are needed for this group at high risk for active TB.
Ingestible smart pills have the potential to be a powerful clinical tool in the diagnosis and treatment of gastrointestinal disease. Though examples of this technology, such as capsule endoscopy, have been successfully translated from the lab into clinically used products, there are still numerous challenges that need to be overcome. This review gives an overview of the research being done in the area of ingestible smart pills and reports on the technical challenges in this field.
The identifcation of vulnerable children following contact with an infectious tuberculosis source case, and their subsequent treatment with effective preventive therapy, reduces the risk of tuberculosis disease progression. The majority of countries in the world recommend preventive therapy for young and human immunodefciency virus-infected children, and yet in most low-resource countries, where the highest burden of tuberculosis exists, delivery is incomplete and inadequate. This opinion paper discusses the provision of preventive therapy in children living in a high-burden setting. It presents the arguments offered by both sides in the debate, and provides the evidence cited by both positions. Finally, the article suggests interventions that could be investigated to improve the uptake of preventive therapy should it be advocated.
Background:
Adherence to antiplatelet medications is critical to prevent life threatening complications (ie, stent thrombosis) after percutaneous coronary interventions (PCIs), yet rates of nonadherence range from 21-57% by 12 months. Mobile interventions delivered via text messaging or mobile apps represent a practical and inexpensive strategy to promote behavior change and enhance medication adherence.
Objective:
The Mobile4Meds study seeks to determine whether text messaging or a mobile app, compared with an educational website control provided to all Veterans, can improve adherence to antiplatelet therapy among patients following acute coronary syndrome (ACS) or PCI. The three aims of the study are to: (1) determine preferences for content and frequency of text messaging to promote medication adherence through focus groups; (2) identify the most patient-centered app that promotes adherence, through a content analysis of all commercially available apps for medication adherence and focus groups centered on usability; and (3) compare adherence to antiplatelet medications in Veterans after ACS/PCI via a randomized clinical trial (RCT).
Methods:
We will utilize a mixed-methods design that uses focus groups to achieve the first and second aims (N=32). Patients will be followed for 12 months after being randomly assigned to one of three arms: (1) customized text messaging, (2) mobile app, or (3) website-control groups (N=225). Medication adherence will be measured with electronic monitoring devices, pharmacy records, and self-reports.
Results:
Enrollment for the focus groups is currently in progress. We expect to enroll patients for the RCT in the beginning of 2018.
Conclusions:
Determining the efficacy of mobile technology using a Veteran-designed protocol to promote medication adherence will have a significant impact on Veteran health and public health, particularly for individuals with chronic diseases that require strict medication adherence.
Trial registration:
ClinicalTrials.gov NCT03022669.
OBJECTIVE: To assess adherence to community-based directly observed treatment (DOT) among Tanzanian tuberculosis patients using the Medication Event Monitoring System (MEMS) and to validate alternative adherence measures for resource-limited settings using MEMS as a gold standard. METHODS: This was a longitudinal pilot study of 50 patients recruited consecutively from one rural hospital, one urban hospital and two urban health centres. Treatment adherence was monitored with MEMS and the validity of the following adherence measures was assessed: isoniazid urine test, urine colour test, Morisky scale, Brief Medication Questionnaire, adapted AIDS Clinical Trials Group (ACTG) adherence questionnaire, pill counts and medication refill visits. FINDINGS: The mean adherence rate in the study population was 96.3% (standard deviation, SD: 7.7). Adherence was less than 100% in 70% of the patients, less than 95% in 21% of them, and less than 80% in 2%. The ACTG adherence questionnaire and urine colour test had the highest sensitivities but lowest specificities. The Morisky scale and refill visits had the highest specificities but lowest sensitivities. Pill counts and refill visits combined, used in routine practice, yielded moderate sensitivity and specificity, but sensitivity improved when the ACTG adherence questionnaire was added. CONCLUSION: Patients on community-based DOT showed good adherence in this study. The combination of pill counts, refill visits and the ACTG adherence questionnaire could be used to monitor adherence in settings where MEMS is not affordable. The findings with regard to adherence and to the validity of simple adherence measures should be confirmed in larger populations with wider variability in adherence rates.
Introduction:
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.
Methods:
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.
Results:
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.
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 use stronger methodological frameworks when comparing measurement methods and be aware that non-electronic measures could lead to overestimation of medication adherence.
The measurement of medication adherence is important in both clinical practice and research settings to offer effective medical therapy, improve clinical outcomes, and determine the efficacy of therapy. The aims of this article are to (a) present an overview of current and developing electronic methods of medication measurement, (b) explore the advantages and disadvantages to each approach, and (c) discuss the implications of using electronic monitoring devices for clinical practice and research. A comprehensive review of electronic forms of medication measurement was performed. A description of each method is presented including oral medication monitors, personal electronic devices, electronic blisters, wirelessly observed therapy, inhaled medication monitors, mobile phones, video/photo-assisted observation, and electronic health records. Familiarity with using electronic devices and advances in technology will continue to develop and influence the measurement of medication adherence.
Purpose:
Non-adherence to chronic medication remains an important problem with vast consequences and without solutions to date. Nurses are well positioned to provide adherence care, yet currently represent an underutilised force in improving adherence and outcomes. This review aims to synthesise the effect of nurse-led interventions on adherence to chronic medication.
Methods:
Using Review Manager software, a meta-analysis was conducted. The search term medication adherence was combined with random* and nurse in PubMed and ISI Web of Knowledge. Retrieved articles' reference lists were hand searched. Included were randomised controlled trials on nurse-led interventions, aiming to improve chronic medication adherence. Articles were to be in English and published from 2006 to 2011. Quality was assessed using an adapted version of the CONSORT tool.
Results:
Ten studies met the selection criteria, seven of which were on HIV-positive patients. Their quality was acceptable to high. Counselling was the intervention most frequently assessed, mostly given face-to-face, but also in groups and via electronic messages. All interventions enhanced adherence. Of the five studies reporting adherence as mean percentage of adherence, pooled mean differences were +5.39 (1.70-9.07) (short term) and +9.49 (4.68-14.30) (long term), favouring the intervention groups. Of the studies reporting adherence dichotomously, odd's ratios were 1.55 (1.04-2.29) (short term) and 1.87 (1.35-2.61) (long term). The longer counselling was effectuated, the better the results.
Conclusions:
Counselling appears to be an effective approach that nurses can use to supplement other methods, building a multifaceted strategy to enhance adherence. Tackling non-adherence seems to demand continuous efforts and follow-up.
At the University Centre for Chronic Diseases Dekkerswald, a tertiary tuberculosis (TB) referral hospital in The Netherlands, therapeutic drug monitoring (TDM) is used in patients in case of relapse TB, when there is delayed response to TB treatment, and when abnormal TB drug concentrations are suspected for other reasons. In this article, a case series is presented to illustrate the value of individualized TB drug dosing in four patients with low TB drug concentrations. Increased doses of the TB drugs, especially of rifampicin, resulted in adequate peak plasma concentrations and improved clinical response to treatment in these patients, while no adverse events occurred.
Aims and objectives:
To investigate whether nurse-led education and counselling enhance phosphate binder adherence in chronic dialysis patients.
Background:
One in two chronic dialysis patients experiences difficulties in adhering to phosphate binders. The reasons for non-adherence are multifactorial and accordingly require a multifaceted strategy. To date, investigations have been confined primarily to single interventions to promote adherence. This study examines the effect of a multifaceted approach.
Design:
The design was interventional.
Method:
Adherence to phosphate binders was blindly and electronically monitored for 17 consecutive weeks with the Medication Event Monitoring System (MEMS). After four weeks baseline monitoring, the effects of the intervention were studied for an additional 13 weeks. In week 5, the study nurse gave all 41 participating patients education on phosphate binders. Thereafter, the study nurse gave bi-weekly personalised counselling to enhance adherence to phosphate binders. The evolution of adherence over time was assessed and compared with historical control data. Secondary outcome variables included serum values of phosphate, calcium and parathyroid hormone and phosphate binder knowledge.
Results:
In week 1, mean adherence was 83% in this study (intervention group), compared with 86% in the historical control group. In the intervention group, mean adherence increased from 83-94% after 13 weeks. By contrast, in the historical control group, mean adherence declined from 86-76%. In the intervention group, serum phosphate values decreased from 4·9-4·3 mg/dl and phosphate binder knowledge increased from a mean score of 53-75%.
Conclusions:
Combining education and continuous counselling holds promise in enhancing phosphate binder adherence. Large-scaled and long-term field studies are indicated to determine which nurse-led practices lead to an integral and sustained medication adherence management.
Relevance to clinical practice:
Nursing strategies to scale up adherence should at least include educating patients and regularly reinforcing adherence behaviour.
Improving treatment adherence in patients with diabetes remains an important objective of behavioral science research. However, progress is often limited by the heterogeneity in methods used to measure treatment adherence and difficulties in generalizing across methodologies. Various measurement methods are often used with little attention paid to questions regarding validity. Doubts about validity of adherence measurement often lead investigators to measure distal clinical outcomes instead, such as glycemic control, resulting in a loss of information. This article provides an overview of the literature on diabetes medication adherence, with a focus on measurement issues. We also consider work conducted in other chronic illnesses, particularly HIV/AIDS, that may have value in guiding future directions of diabetes medication adherence research. We highlight the need for focused investigation on how characteristics of self-report methodologies affect the validity of patient responses and conclude with practical recommendations based on the current state of the science.
Imatinib mesylate is currently the standard therapy for chronic myelogenous leukemia patients. Despite the remarkable results achieved with imatinib, the emergence of resistance to this drug has become a significant problem. Actually, two other second-generation tyrosine kinase inhibitors have been used for resistant/intolerant patients to imatinib. With the availability of oral tyrosine kinase inhibitors for the treatment of chronic myelogenous leukemia, questions relating to adherence to prescribed therapy have become an important issue. It has been demonstrated that the effectiveness of the treatment with imatinib requires high compliance to the prescribed dose of the drug for an indefinite period of time, whereas reduced adherence to therapy has been associated with delay in achieving cytogenetic or molecular response and/or possible development of resistance. The aim of this review is to discuss the importance of adherence, and the possible tools that we have to measure it, to improve our knowledge on possible underlying causes of non-adherence and the impact of non-adherence on hospitalization risk and healthcare cost through a systematic review of the data published to date.
The purpose of this paper is to describe electronic monitoring device (EMD) (e.g., MEMS caps) use among HIV-infected adults enrolled in a randomized clinical trial and to make explicit some of the benefits and caveats of using electronic monitoring device technology. This is a descriptive, exploratory study of EMD use among 128 HIV-infected adults treated with at least three antiretroviral agents. Thirty-six percent of the sample admitted that they did not use the EMD consistently. Forty-one percent of the subjects reported taking out more than one dose at a time and 26% reported opening the EMD but not taking the medication. Special subject-related issues accounted for only a small percentage of all reported problems with EMD use (e.g., transient housing, incarceration, substance abuse relapse and drug treatment). Results of this study suggest that EMDs may underestimate antiretroviral adherence among HIV-infected adults. Recommendations for improving EMD data quality are presented.
The objectives of this study were to describe and pilot-test a theory- and evidence-based intervention to improve adherence of HIV-infected patients with antiretroviral medication. Twenty-six treatment-experienced patients (>6 months on treatment) participated in a within-subject comparison design. Adherence was measured electronically with Medication Event Monitoring System (MEMS) caps for at least 5 months: 2 months before the intervention and 3 months during the intervention. MEMS data were used to measure the outcome of the intervention, but also served as feedback to participants during the intervention. Mean adherence during the month before intervention was compared to mean adherence during the third month of intervention. Data for the process evaluation were gathered through direct observation and semi-structured interviews. Adherence improved significantly during the intervention (Z = -2.1, p < 0.05). Mean adherence (percentage of prescribed doses taken within correct time interval) before the intervention was 81.8% compared to 92.5% during the third month of the intervention. More than 65% of the nonadherent patients (<95% adherence) before the intervention were adherent during the third month of the intervention. Both health care professionals and patients positively evaluated the intervention protocol and the electronic measurement of adherence. The only critique from some patients was the lack of userfriendliness of the MEMS cap and its medication container (size and shape). It can be concluded that the proposed intervention fits in standard care procedures, can be executed by trained HIV nurses, seems to improve adherence to antiretroviral medication, and is positively evaluated by the users. Large-scale and long-term research is warranted.
The relationship between patient adherence and treatment outcomes has been documented across chronic health conditions, but the evidence base for effective adherence interventions in human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) requires more rigorous research and reporting.
The aims of this study were to determine whether a tailored, nurse-delivered adherence intervention program--Client Adherence Profiling and Intervention Tailoring (CAP-IT)--improved adherence to HIV medications, compared with standard care, and to identify the relationship among adherence measures.
A randomized controlled trial (RCT) with repeated measures was used to test the efficacy of CAP-IT over a 6-month period. A convenience sample of 240 participants was recruited from a freestanding public HIV/AIDS clinic in Houston, TX, that provides medical, psychological, and pharmaceutical services for over 5,000 clients. Study instruments and measures included demographics; chart audit to capture CD4 count, viral load, and prescribed medications; health literacy; and five measures of adherence (AIDS Clinical Trial Group-Revised Reasons for Missing Medications, Morisky Self-Report of Medication Non-Adherence, Pill Count, Medication Event Monitoring System [MEMS] caps, and Pharmacy Refill).
A logistic regression using generalized estimating equations method showed no significant differences over time on the five medication-adherence measures between the experimental and control groups. Little correlation was documented among the five different adherence measures, and there was minimal correlation with clinical markers.
It is unclear why the tailored adherence intervention was not efficacious in improving medication adherence. The findings suggest that these measures of medication adherence did not perform as expected and that, perhaps, they are not adequate measures of adherence. Effective and efficient adherence interventions are needed to address the barriers to medication adherence in HIV/AIDS.
In the United States, the number of annual reported cases of tuberculosis (TB) among U.S.-born persons declined by 62% from 1993 to 2004, but increased by 5% among foreign-born persons. Over half of all reported cases of TB in the United States occur among foreign-born persons, most of these due to activation of latent TB infection (LTBI). Current guidelines recommend targeting only foreign-born persons who entered the United States within the previous 5 yr for LTBI testing.
We sought to assess the epidemiologic basis for this guideline.
We calculated TB case rates among foreign-born persons, stratified by duration of United States residence and world region of origin. We determined the number of cases using 2004 U.S. TB surveillance data, and calculated case rates using population data from the 2004 American Community Survey.
In 2004, a total of 14,517 cases of TB were reported; 3,444 (24%) of these were among foreign-born persons who had entered the United States more than 5 yr previously. The rate of TB disease among foreign-born persons was 21.5/100,000, compared with 2.7/100,000 for U.S.-born persons, and varied by duration of residence and world region of origin.
Almost one-quarter of all TB cases in the United States occur among foreign-born persons who have resided in the United States for longer than 5 yr; case rates for such persons from selected regions of origin remain substantially elevated. To eliminate TB, we must address the burden of LTBI in this high-risk group.
The measurement of adherence to antiretroviral medications has become a major focus of HIV research. Accurate means of assessing adherence is critical. The HIV epidemic has provided unique challenges in the quest to accurately determine adherence to medications. The strengths and weaknesses of the most common means for assessing adherence are briefly reviewed. Case studies from a research study assessing adherence in alcohol abusing patients with HIV are presented to illustrate the actual use of the Medication Events Monitoring System (MEMS) and patient self-report in a clinical research setting. Practical recommendations for optimizing measurement of adherence are provided. In research studies examining adherence to HIV medications, MEMS's potential to provide detailed accurate adherence information may be quite limited because of the complexity of the regimen, patient lifestyle factors, and the use of adherence aids such as pill boxes. Innovative measurement of medication adherence remains a critical research priority.
Previous reviews of the literature on medication compliance have confirmed the inverse relationship between number of daily doses and rate of compliance. However, compliance in most of these studies was based on patient self-report, blood-level monitoring, prescription refills, or pill count data, none of which are as accurate as electronic monitoring (EM).
In this paper, we review studies in which compliance was measured with an EM device to determine the associations between dose frequency and medication compliance.
Articles included in this review were identified through literature searches of MEDLINE, PsychInfo, HealthStar, Health & Psychosocial Instruments, and the Cochrane Library using the search terms patient compliance, patient adherence, electronic monitoring, and MEMS (medication event monitoring systems). The review was limited to studies reporting compliance measured by EM devices, the most accurate compliance assessment method to date. Because EM was introduced only in 1986, the literature search was restricted to the years 1986 to 2000. In the identified studies, data were pooled to calculate mean compliance with once-daily, twice-daily, 3-times-daily, and 4-times-daily dosing regimens. Because of heterogeneity in definitions of compliance, 2 major categories of compliance rates were defined: dose-taking (taking the prescribed number of pills each day) and dose-timing (taking pills within the prescribed time frame).
A total of 76 studies were identified. Mean dose-taking compliance was 71% +/- 17% (range, 34%-97%) and declined as the number of daily doses increased: 1 dose = 79% +/- 14%, 2 doses = 69% +/- 15%, 3 doses = 65% +/- 16%, 4 doses = 51% +/- 20% (P < 0.001 among dose schedules). Compliance was significantly higher for once-daily versus 3-times-daily (P = 0.008), once-daily versus 4-times-daily (P < 0.001), and twice-daily versus 4-times-daily regimens (P = 0.001); however, there were no significant differences in compliance between once-daily and twice-daily regimens or between twice-daily and 3-times-daily regimens. In the subset of 14 studies that reported dose-timing results, mean dose-timing compliance was 59% +/- 24%; more frequent dosing was associated with lower compliance rates.
A review of studies that measured compliance using EM confirmed that the prescribed number of doses per day is inversely related to compliance. Simpler, less frequent dosing regimens resulted in better compliance across a variety of therapeutic classes.
This study examined the validity of the Arkansas urine test. One hundred ninety-four adolescents submitted an unannounced urine specimen monthly (for 6 to 8 months). Duplicate specimens were blindly tested with high agreement (kappa >90%). Sensitivity and specificity were estimated. In 68% of test runs, adolescents recalled taking INH within 24 hr of specimen collection. For recall intervals of 24, 48, and 72 hr, sensitivity was 87, 85, and 83%, respectively. Females were less likely to test positive when INH was taken within the previous 24 hr (sensitivity 84 versus 92% males). Specificity was 57, 91, and 95% at 24, 48, and 72 hr, respectively. The Arkansas urine test was practical to use, and results correlated well with self-reported adherence to INH for treatment of latent tuberculosis infection (LTBI), over several months of follow-up. The test may be useful as part of an adherence-monitoring program when used in conjunction with self-reported measures.
Adherence is a factor in the outcome of medical treatment, but the strength and moderators of the adherence-outcome association have not been systematically assessed.
A quantitative review using meta-analysis of three decades of empirical research correlating adherence with objective measures of treatment outcomes.
Sixty-three studies assessing patient adherence and outcomes of medical treatment were found involving medical regimens recommended by a nonpsychiatrist physician, and measuring patient adherence and health outcomes. Studies were analyzed according to disease (acute/chronic, severity), population (adult/child), type of regimen (preventive/treatment, use of medication), and type and sensitivity of adherence and outcomes measurements.
Overall, the outcome difference between high and low adherence is 26%. According to a stringent random effects model, adherence is most strongly related to outcomes in studies of nonmedication regimens, where measures of adherence are continuous, and where the disease is chronic (particularly hypertension, hypercholesterolemia, intestinal disease, and sleep apnea). A less stringent fixed effects model shows a trend for higher adherence-outcome correlations in studies of less serious conditions, of pediatric patients, and in those studies using self-reports of adherence, multiple measures of adherence, and less specific measures of outcomes. Intercorrelations among moderator variables in multiple regression show that the best predictor of the adherence-outcome relationship is methodological-the sensitivity/quality of the adherence assessment.
Although the use of highly active antiretroviral therapy in the treatment of HIV infection has led to considerable improvement in morbidity and mortality, unless patients are adherent to their drug regimen (i.e., at least 90 to 95% of doses taken), viral replication may ensue and drug-resistant strains of the virus may emerge.
The authors studied the extent to which neuropsychological compromise and medication regimen complexity are predictive of poor adherence in a convenience sample of 137 HIV-infected adults. Medication adherence was tracked through the use of electronic monitoring technology (MEMS caps).
Two-way analysis of variance revealed that neurocognitive compromise as well as complex medication regimens were associated with significantly lower adherence rates. Cognitively compromised participants on more complex regimens had the greatest difficulty with adherence. Deficits in executive function, memory, and attention were associated with poor adherence. Logistic regression analysis demonstrated that neuropsychological compromise was associated with a 2.3 times greater risk of adherence failure. Older age (>50 years) was also found to be associated with significantly better adherence.
HIV-infected adults with significant neurocognitive compromise are at risk for poor medication adherence, particularly if they have been prescribed a complex dosing regimen. As such, simpler dosing schedules for more cognitively impaired patients might improve adherence.
To apply the Arkansas color method in order to evaluate drug compliance and factors that can predict treatment adherence in patients being treated for latent tuberculosis infection (LTBI) with a single daily dose of isoniazid (INH).
Prospective study of adherence of 105 patients aged 1 to 75 years who were treated with a single daily dose of INH for LTBI.
Patients or their parents were interviewed regarding parameters that may affect compliance. Urine samples were collected and tested for INH metabolites with the Arkansas color method.
Nonadherence to treatment was found in 28.5% of patients. There was no statistically significant correlation among the following parameters: gender; age; diagnosis; mode of administration (self or parents); duration of treatment; dose of INH per weight; or interval since last intake of dose. Twenty-six patients were randomly checked for treatment adherence on two separate visits, and nonadherent patients were informed immediately and their condition was fully explained to them. Five of six patients who were nonadherent in the first visit and were examined twice became adherent in the second visit. Three of 20 patients who were adherent in the first visit became nonadherent.
Almost one third of the patients who received LTBI treatment with INH were nonadherent to treatment. No factor was found to predict adherence. The Arkansas method can be used by the family physician and is a simple, immediate method to follow-up patients with LTBI who are treated with INH.
San Francisco TB Clinic instituted a directly observed preventive therapy (DOPT) program for treatment of persons with latent TB infection in 1996.
To examine therapy completion for latent tuberculosis infection before and after implementation of the DOPT program.
Medical records were analyzed for patients at the San Francisco TB Clinic referred from high-risk sites for the periods 1993-1994 (n = 619) and 1997-June 1998 (n = 460). Treatment completion and time of therapy were analyzed comparing DOPT to self-administered therapy (SAT).
More DOPT patients completed treatment (70.3%) than SAT patients (47.9%) (P < 0.001). Controlling for sex, age, race/ethnic group and cohort, patients on DOPT were nearly twice as likely to complete therapy (OR 1.93, 95% CI 1.25-3.00).
DOPT is a successful strategy. Combined with targeted testing, DOPT can have an important impact in areas with traditionally low rates of treatment adherence.
A variety of methods have been used to measure medication compliance. Although electronic monitoring has been considered to be the best method, it has some potential for error and its high cost may limit its feasibility. This study examined the concordance of data on medication compliance that was obtained by using an electronic monitoring system (Medication Event Monitoring System, or MEMS), daily diary reports, and tablet counts.
Subjects were 150 problem drinkers participating in a pharmacotherapy trial. Subjects were randomly assigned to receive naltrexone 50 mg (n = 75) or placebo (n = 75) and to receive either daily (n = 72) or targeted (n = 78) medication administration. Comparisons between methods were conducted at the aggregate and individual daily levels, and the association between compliance and three alcohol-related outcomes was evaluated.
Daily diaries showed good day-to-day concordance with MEMS and a higher correlation with MEMS than did tablet counts. However, high-compliance subjects did no better than low-compliance subjects on any of three alcohol-related outcome measures.
Compliance measurement using a daily diary method yielded results that are comparable to those obtained with electronic monitoring, which served as a criterion measure. In contrast, tablet counts provided data that were less concordant with the criterion measure. The unique nature of the study sample (i.e., the majority of subjects were not committed to a goal of abstinence), combined with the targeted approach to treatment, may explain the lack of association between compliance and alcohol-related outcomes. Further research should aim to ascertain the factors affecting the relationship between compliance and outcomes.
Non-adherence in hypertension is a global problem and promoting adherence is necessary to decrease cardiovascular mortality.
The purpose of this paper is to examine the measurement of adherence to medication taking in hypertensive patients. Adherence was evaluated primarily by means of MEMS (Medication Event Monitoring System, Aprex Corporation, Fremont, California) an electronic system that records the date and time of opening of the study medication container. Additional measurements such as change in urinary potassium level, capsule count, client self report and physician estimate of adherence were recorded.
A randomised clinical trial was used to assign patients to receive the study medication (potassium) or placebo. Descriptive statistics were used to answer the research questions. Frequency and percentage of responses to different measures of adherence were carried out as well as correlation between the measures.
One hundred and seven subjects between the ages of 26 and 80 participated in the clinical trial. The results showed that adherence measures varied with lowest adherence from two items of self-report related to forgetfulness (46 and 55%) and stringent electronic monitoring with the MEMS (58%) to percentages in the 80-90 range for other self-report items and the general adherence scale. Electronic monitoring correlated best with capsule count at visit 5. Implications for health care providers are discussed.
The prevention of active tuberculosis through the treatment of latent tuberculosis infection is a major element of the national strategy for eliminating tuberculosis in the United States. Targeted treatment for persons who are at the highest risk for reactivation tuberculosis will be needed to achieve this goal. A more precise assessment of the lifetime risk of reactivation tuberculosis, usually estimated at 5 to 10 percent, could help to identify patients who are at the highest risk and motivate them to complete treatment. Currently, the rate of completion of treatment is low.
Published reports were reviewed to obtain estimates of the risk of tuberculosis among persons with a positive tuberculin skin test. Using these data, I constructed a model to estimate the lifetime risk of tuberculosis among persons with specific medical conditions.
The lifetime risk of reactivation tuberculosis is 20 percent or more among most persons with induration of 10 mm or more on a tuberculin skin test and either human immunodeficiency virus infection or evidence of old, healed tuberculosis. The lifetime risk is 10 to 20 percent among persons with recent conversion of a tuberculin skin test and among most persons younger than 35 years of age who are receiving infliximab therapy and have induration of 15 mm or more on a tuberculin skin test. The risk is also 10 to 20 percent among children five years of age or younger who have induration of 10 mm or more on a tuberculin skin test.
Persons with these characteristics should be targeted for intensive efforts to ensure full treatment of latent tuberculosis. Improved rates of completion of treatment among such persons could help to eliminate tuberculosis in the United States.
To test the reliability and validity of 8-day and 30-day self-report measures of adherence to daily isoniazid (INH) for treatment of latent tuberculosis infection (LTBI).
Participants were 286 Latino adolescents (ages 13-18, 55.6% male) with LTBI recruited from 10 public middle and high schools in San Diego County. INH adherence was measured monthly for up to 9 months by interview and urine specimens at unannounced visits. Reliability and validity analyses were performed within 5 consecutive months. Reliability was assessed by correlating: (1) 8- and 30-day INH adherence measures within each month; and (2) each of the two adherence measures across months. Validity was assessed by correlating reported measures with biological assays within each month.
Reliability tests yielded significant correlation coefficients (p < .05 to .001), both across measures (r = 0.71-0.93) and across time (r = 0.29-0.64 for 8-day recall; r = 0.32-0.69 for 30-day recall). Validity tests of both adherence measures were also significant (p < .05 to .001): 8-day recall (r(pb) = 0.52-0.72) and 30-day recall (r(pb) = 0.37-0.71).
Results suggest that impromptu recall measures of INH adherence, combined with urine collection, are reliable and valid in Latino adolescents.
Current therapy for latent TB infection (LTBI) is long, and requires close follow-up. This results in sub-optimal adherence-the major reason for failure of therapy.
In an open label randomised trial comparing 4 months of rifampicin with 9 months of isoniazid, the proportion and regularity of doses taken, measured with an electronic monitoring system (MEMS), and provider estimates of adherence in the first month of therapy, were assessed as predictors of treatment completion.
Of 104 patients analysed, 86 took more than 80% of doses within the expected interval, 11 took more than 80% of doses but over a longer time interval than usually allowed, and seven did not complete treatment. Treatment completion was associated with the number of doses taken, and the variability of intervals between doses during the first month of treatment.
Adherence in the first month, based on the number of doses and variability of times when taken, could be useful to predict completion of LTBI therapy. Interventions could be targeted to patients with suboptimal adherence in the first month.
Few rigorously designed studies have documented the efficacy of interventions to improve medication adherence among patients prescribed highly active antiretroviral. Data are needed to justify the use of limited resources for these programs.
A 2-arm, randomized, controlled trial evaluated the efficacy of a community-based, home-visit intervention to improve medication adherence. Participants were 171 HIV-infected adults prescribed a minimum of 3 antiretroviral agents. The majority had a past or current history of substance abuse. Subjects were randomly assigned to receive home visits for 1 year or usual care. Medication adherence was assessed with Medication Event Monitoring stem caps at 3-month intervals from randomization through 3 months after the conclusion of the intervention.
A larger proportion of subjects in the intervention group demonstrated adherence greater than 90% compared with the control group at each time point after baseline. The difference over time was statistically significant (Extended Mantel-Haenszel test: 5.80, P = 0.02). A statistically significant intervention effect on HIV-RNA level or CD4 cell count was not seen, but there was a statistically significant association between greater than 90% adherence and an undetectable HIV-RNA over time (P < 0.03).
Home visits from a nurse and a community worker were associated with medication adherence greater than 90% among a cohort of socially vulnerable people living with HIV/AIDS in northeastern United States.
One third of the world population is infected with Mycobacterium tuberculosis. In the United States, a key component for eliminating tuberculosis (TB) is treating latent TB infection (LTBI) in high-risk persons such as immigrants.
Examine the prevalence of adherence to LTBI therapy and the influence of basic conditioning factors on adherence among Latino immigrants, guided by Orem's Self-Care Deficit Theory. Adherence was treated as a health deviation self-care requisite; the self-care practice of taking daily medication for 9 months is essential to LTBI adherence. Conditioning factors include gender, age, sociocultural factors, environment, and health state.
Exploratory, cross-sectional.
Nonprobability sample (n=53) of Latino immigrants attending an urban public health clinic in the Washington, DC metropolitan area.
Participants completed a brief questionnaire documenting selected conditioning factors, and 9-month adherence to LTBI therapy was determined from their medical records.
Adherence dropped from 98% in month 2 to 72% at 9 months. The mean number of months adherent was 7.4. Adherence was not significantly associated with gender, country of origin, languages spoken, age, education, or years in the United States. Adherence was slightly lower (t=2.059, p=.059) in persons who knew someone with TB.
Nurses should emphasize the importance of adherence for the full 9 months to this population.
Tuberculosis among foreign-born persons in the United States achieving tuberculosis elimination Guide for primary health care providers: Targeted tuberculin testing and treatment of latent tuberculosis infection
- Kp Cain
- Ca Haley
- Lr Armstrong
- Kn Garman
- Cc Wells
- Mf Lademarco
Cain KP, Haley CA, Armstrong LR, Garman KN, Wells CC, Lademarco MF, et al. Tuberculosis among
foreign-born persons in the United States achieving tuberculosis elimination. American Journal of
Respiratory & Critical Care Medicine 2007;175:75–79. [PubMed: 17038659]
Centers for Disease Control and Prevention. Guide for primary health care providers: Targeted tuberculin
testing and treatment of latent tuberculosis infection 2005. 2005. Retrieved May 22, 2006, from
http://www.cdc.gov/tb/pubs/LTBI/treatment.htm