ESPACOMP Medication Adherence Reporting Guidelines (EMERGE): a reactive-Delphi study protocol.

INTRODUCTION: Medication adherence is fundamental to achieving optimal patient outcomes. Reporting research on medication adherence suffers from some issues-including conceptualisation, measurement and data analysis-that thwart its advancement. Using the ABC taxonomy for medication adherence as the conceptual basis, a steering committee of members of the European Society for Patient Adherence, COMpliance, and Persistence (ESPACOMP) launched an initiative to develop ESPACOMP Medication Adherence Reporting Guidelines (EMERGE). This paper is a protocol for a Delphi study that aims to build consensus among a group of topic experts regarding an item list that will support developing EMERGE. METHODS AND ANALYSIS: This study uses a reactive-Delphi design where a group of topic experts will be asked to rate the relevance and clarity of an initial list of items, in addition to suggesting further items and/or modifications of the initial items. The initial item list, generated by the EMERGE steering committee through a structured process, consists of 26 items distributed in 2 sections: 4 items representing the taxonomy-based minimum reporting criteria, and 22 items organised according to the common reporting sections. A purposive sample of experts will be selected from relevant disciplines and diverse geographical locations. Consensus will be achieved through predefined decision rules to keep, delete or modify the items. An iterative process of online survey rounds will be carried out until consensus is reached. ETHICS AND DISSEMINATION: An ethics approval was not required for the study according to the Swiss federal act on research involving human beings. The participating experts will be asked to give an informed consent. The results of this Delphi study will feed into EMERGE, which will be disseminated through peer-reviewed publications and presentations at conferences. Additionally, the steering committee will encourage their endorsement by registering the guidelines at the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network and other relevant organisations.

Predictors of adherence in the Women's Health Initiative Calcium and Vitamin D Trial.

The authors analyzed data from the Women's Health Initiative (WHI) Calcium and Vitamin D Supplementation Trial (CaD) to learn more about factors affecting adherence to clinical trial study pills (both active and placebo). Most participants (36,282 postmenopausal women aged 50-79 years) enrolled in CaD 1 year after joining either a hormone trial or the dietary modification trial of WHI. The WHI researchers measured adherence to study pills by weighing the amount of remaining pills at an annual study visit; adherence was primarily defined as taking > or = 80% of the pills. The authors in this study examined a number of behavioral, demographic, procedural, and treatment variables for association with study pill adherence. They found that relatively simple procedures (ie, phone contact early in the study [4 weeks post randomization] and direct social contact) later in the trial may improve adherence. Also, at baseline, past pill-use experiences, personal supplement use, and relevant symptoms may be predictive of adherence in a supplement trial.

Treatment adherence in chronic disease.

Research has addressed the problem of poor adherence for the past 4 decades. Much of the research has focused on the prevalence and predictors of adherence, research methodologies, and the development of measures of adherence. To a much lesser extent, attention has been given to intervention studies designed to evaluate strategies to improve adherence to treatment regimens. This article provides an up-to-date review of the literature on medication adherence in chronic disease.

Primary care patients' personal illness models for depression: a preliminary investigation.

BACKGROUND: Despite the fact that more than half of depressed persons are treated for this disorder by primary care physicians, depression is often under-recognized or treated inadequately. There is continued emphasis on effective treatment of depression in primary care patients, but little attention has been paid to the role of the depressed person's illness cognitions in coping with this disorder. Given the often recurring and chronic nature of depression, the individual's self-management strategies may be critical to effective treatment, recovery and remaining well. OBJECTIVES: The purpose of this pilot study was to determine whether primary care patients' personal illness cognitions for depression are associated with depression coping strategies and treatment-related behaviour. METHODS: Forty-one primary care patients with depressive symptoms or disorder completed interviews and questionnaires assessing illness cognitions for depression, depression coping strategies and other treatment-related behaviour. Descriptive statistics are used to present patients' illness cognitions for depression. t-tests and correlational analyses were completed to assess the relationship between illness cognitions, depression coping strategies and treatment-related behaviour. RESULTS: Preliminary data describing illness cognitions for depression are presented. Participants' illness cognitions for depression were significantly associated with current and past treatment-seeking behaviour, medication adherence and coping strategies. CONCLUSIONS: Although preliminary, these findings indicate that patients' understanding of depression and its consequences are associated with how they manage this illness. Future research is needed to examine the mediating and moderating effects of illness cognitions for depression on medication adherence and other self-management behaviours of depressed primary care patients. Knowledge about primary care patients' personal illness models will aid in the development of adherence interventions, self-management training and support services appropriate to patients' needs in the primary care setting.

Accuracy of children's self-reported adherence to treatment.

PURPOSE: To examine the relationship between self-reported and electronically monitored adherence to a recommended asthma treatment and to assess the accuracy of the diary data reported by school-age children. DESIGN: A randomized, controlled clinical trial of the effectiveness of an asthma self-management program. The relationship between self-reported and electronically recorded daily peak expiratory flow rate (PEFR) adherence was assessed in a sample of 42 children, ages 7 through 11 years with moderate to severe asthma in one community in West Virginia, USA. Cognitive social learning theory served as the framework for the intervention. METHODS: At-home adherence to PEFR monitoring during the 5-week study was evaluated using the self-report Asthma Diary and an electronic PEFR meter. Recommended twice daily (morning and evening) PEFR monitoring was measured. RESULTS: Self-reported and electronically recorded PEFR adherence were modestly correlated. Self-reported adherence was significantly higher than electronically monitored adherence during Week 5. Accuracy of the self-reported PEFR declined over time, and over half of the children fabricated at least one PEFR value during the final week of the study. CONCLUSIONS: Clinicians often evaluate the efficacy of prescribed treatment for children with chronic conditions based on the children's self-reported diary data. The findings indicate that these children's self-reported adherence behaviors contained errors. Parent education regarding supervision of children's adherence, including validating the accuracy of diary data, is critical for successful self-management in children with chronic conditions.

Who will adhere? Key issues in the study and prediction of adherence in randomized controlled trials.

Adherence determinants and key adherence research issues are discussed for three types of randomized controlled trials: pharmacological, dietary, and physical activity. This article highlights theoretical and methodological limitations that have hampered the ability to identify patients at risk for poor treatment compliance. Control Clin Trials 2000;21:195S-199S

Adherence in chronic disease.

Nonadherence to treatment regimen is a prevalent problem of patients with chronic disorders. Approximately half of the patients with a chronic disease have problems following their prescribed regimen to the extent that they are unable to obtain optimum clinical benefit. This chapter reviews the state of knowledge regarding adherence to chronic disease regimens across the life span and demonstrates that the extent and nature of the adherence problems are similar across diseases, across regimens, and across age groups. Adherence to the commonly prescribed regimens is addressed, including pharmacological therapies, therapeutic diets, and therapeutic exercise. Randomized, controlled studies focusing on various educational, behavioral, cognitive, and affective interventions to improve adherence are included. Based on this review, further work is needed to better understand and improve adherence. New strategies for analysis and measurement will support these needed advances in the field of adherence.

Cognitive function and quality of life in interferon therapy for melanoma.

The purpose of this pilot study was to describe short- and long-term changes in cognitive function and quality of life in patients with melanoma receiving interferon (IFN) alpha-2b. This study used a three-group, repeated measures design in which cognitive function and quality of life were evaluated prior to initiation of treatment at 3-month intervals during treatment and 3 months following the completion of treatment. The sample consisted of 16 adults with Stage II or III melanoma, randomized to one of three treatment groups. Participants in Arm A received high-dose IFN alpha-2b, those in Arm B received low-dose IFN alpha-2b, and those in Arm C received no therapy (control). No significant changes in cognitive function were detected. In participants in Arm A, there was a significant deterioration in the physical well-being dimension of quality of life from baseline to 3 months after beginning therapy.

Compliance with inhaled medications: the relationship between diary and electronic monitor.

Self-report is a frequently-used method of assessing compliance with prescribed medications in patients with chronic illnesses. Most researchers agree, however, that self-report misrepresents patient adherence to regimen prescription. In this randomized, controlled study evaluating inhaler medication compliance, diary data was compared to electronic monitoring in 55 adults with asthma. Subjects randomized to the treatment group received a six-week self-management program. An electronic monitor, the MDI Chronolog, was used in this study to assess inhaler use. The MDI Chronolog records the date and time of each inhaled activation. The self-report measure used was a daily asthma diary. Subjects were asked to use their inhaled medications as usual and record the date and time they administered their medication over a one-week period. Moderate correlations (rs = .55, Mdnd = 95.8, Mdnc = 91.6) were found when comparing the number of administrations calculated using the MDI Chronolog to the number of administrations reported in the subject's diary. When the dosing interval was examined, however, the correlation was weaker (rs = .44, Mdndiary = 92.8, Mdnchronolog = 37.5). In each case, self-reported compliance was higher than monitored adherence.

Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36.

The purpose of this report is to examine health-related quality of life (HRQoL) as measured by the Medical Outcomes Study Short Form-36, across patient populations with chronic disorders and to compare quality of life (QoL) in these subjects with normative data on healthy persons. Six studies, within the Center for Research in Chronic Disorders at the University of Pittsburgh School of Nursing, in patients with urinary incontinence, prostate cancer, chronic obstructive pulmonary disease (COPD), acquired immune deficiency syndrome (AIDS), fibromyalgia and hyperlipidaemia provided the data for analysis. The results demonstrated that not only did the prostate cancer and hyperlipidaemia patients have the highest QoL across the chronic disorders, but their QoL was comparable to normative data on healthy persons. Homebound, elderly, incontinent patients had the lowest QoL for physical functioning, whereas patients hospitalized with AIDS had the lowest QoL in general health and social functioning. Patients with COPD had the lowest QoL in role-physical, role-emotional and mental health. Patients with fibromyalgia had the lowest QoL in bodily pain and vitality. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia generally had lower QoL. Prostate cancer and hyperlipidaemia patients had QoL comparable to normative data. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia had more variability for role-emotional. AIDS patients had more variability on physical functioning, bodily pain and social functioning compared to the normative data. These data suggest that patients with various chronic disorders may have QoL that is lower in most domains compared to a healthy population. However, there may be differences in the domains affected as well as the extent of variation across specific chronic disorders.

An evaluation of a self-management program for adults with asthma.

The purpose of this study was to evaluate the impact of a self-management program for adults with moderate to severe asthma on compliance with inhaled, prescribed, nonemergency medications; asthma symptoms; and airway obstruction. In this controlled experimental study, 55 subjects from a rural community were randomized to one of two groups. Self-efficacy theory served as the framework for this study. Primary measures included the Metered Dose Inhaler (MDI) Chronolog, a journal of daily asthma concerns, and a peak-flow meter to appraise airway obstruction. Secondary measures included the Asthma Self-Management Assessment Tool (ASMAT) and the Self-Efficacy for Asthma Management Scale (SEAMS). These measures were completed pre- and post-intervention. Data analysis using descriptive and inferential statistics revealed that subjects receiving the self-management program increased compliance with inhaled medications (U = 271, p = .043).

Compliance with cardiovascular disease prevention strategies: a review of the research.

The efficacy of cardiovascular risk-reduction programs has been established. However, the extent to which risk-reduction interventions are effective may depend on adherence. Non-compliance, or non-adherence, may occur with any of the recommended or prescribed regimens and may vary across the treatment course. Compliance problems, whether occurring early or late in the treatment course, are clinically significant, as adherence is one mediator of the clinical outcome. This article, which is based on a review of the empirical literature of the past 20 years, addresses compliance across four regimens of cardiovascular risk reduction: pharmacological therapy, exercise, nutrition, and smoking cessation. The criteria for inclusion of a study in this review were: (a) focus on cardiovascular disease risk reduction; (b) report of a quantitative measure of compliance behavior; and (c) use of a randomized controlled design. Forty-six studies meeting these criteria were identified. A variety of self-report, objective, and electronic measurement methods were used across these studies. The interventions employed diverse combinations of cognitive, educational, and behavioral strategies to improve compliance in an array of settings. The strategies demonstrated to be successful in improving compliance included behavioral skill training, self-monitoring, telephone/mail contact, self-efficacy enhancement, and external cognitive aids. A series of tables summarize the intervention strategies, compliance measures, and findings, as well as the interventions demonstrated to be successful. This review reflects the progress made over two decades in compliance measurement and research and, further, advances made in the application of behavioral strategies to the promotion of cardiovascular risk reduction.

Adherence to medication, diet, and activity recommendations: from assessment to maintenance.

Inadequate adherence to treatment regimens has been a concern of health care providers for more than two decades. However, it continues to have a significant impact on morbidity and health care cost. Poor adherence crosses ethnic and age groups, socioeconomic strata, acute and chronic diseases, and treatment regimens. Depending on the population, the prescribed regimen, and the definition or measure of adherence used, rates vary from 10% to 85%. The consequences of absent or partial adherence are observed in the research arena and all types of clinical settings. Educational and behavioral strategies may prevent or remediate adherence problems.

Contributions to patient adherence: is it time to share the blame?

Poor adherence to treatment is well recognized and contributes significantly to treatment failures in medical care. Studies examining contributing factors have focused predominantly on the patient. Studies examining provider influences have primarily examined communication styles or educational practices. Di Matteo et al. show, in this issue of Health Psychology, that other characteristics of the provider may influence patient behavior. Particularly interesting is the finding that baseline adherence predicts adherence 2 years later. Although this study opens the door to an examination of provider characteristics and their influence on patient behavior, care needs to be taken to avoid too rapid an acceptance of the discrete findings. The study used self-report by interview, a measure that can be significantly biased. However, this study provides future avenues to explore using more objective measures of patient adherence.