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Betsema L, Yang M, Bohr A, Herrera A, Kaae S. Cystic fibrosis patients' preferences for electronic devices that monitor their inhalation - A qualitative study. Respir Med 2025; 238:107980. [PMID: 39894083 DOI: 10.1016/j.rmed.2025.107980] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2024] [Revised: 12/12/2024] [Accepted: 01/28/2025] [Indexed: 02/04/2025]
Abstract
BACKGROUND Patients with cystic fibrosis (CF) use inhaled medicines daily due to respiratory manifestations. However, only 31 % of users is inhaling correctly. Digital solutions targeting inhalation could help CF patients improve their technique and thus health outcomes. However, the use of electronic monitoring devices shows a decrease over time. Therefore, the aim of study was to investigate CF patients' preferences for the use of electronic devices on their inhalation technique on a regular basis and reasons behind these preferences. METHODS Semistructured interviews were conducted with 11 CF patients from four European countries to understand their disease history and experiences, daily use of inhaler medication, experiences with digital devices to achieve disease control, and expectations of new devices for monitoring inhalation. A conventional content analysis was applied. RESULTS CF patients knew their body well due to their lifelong experiences. However, some patients still experienced periods with more symptoms and need for support. Non-app support was preferred. CF patients reported that digital systems should provide high benefits for regular use. Patients differed in their interest in digital systems for inhalation. Such systems were mostly relevant to CF patients starting a new inhaled treatment/inhaler device or during periods in which the disease was out of control. CONCLUSIONS CF patients perceived limited value of digital systems to monitor their inhalation and mostly considered them necessary for specific periods. Extensive experience in using inhalers and existing daily routines to manage a high treatment burden appear involved in limited need of such systems.
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Affiliation(s)
- Lyan Betsema
- Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, København Ø, 2100, Denmark
| | - Mingshi Yang
- Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, København Ø, 2100, Denmark
| | - Adam Bohr
- Sonohaler, Diplomvej 373, 2800 Kongens Lyngby, Denmark
| | | | - Susanne Kaae
- Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Universitetsparken 2, København Ø, 2100, Denmark.
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Başkaya E, Demir S. The problems and information needs of patients with bipolar disorder during the treatment process: A qualitative study in Turkey. Arch Psychiatr Nurs 2023; 42:45-54. [PMID: 36842827 DOI: 10.1016/j.apnu.2022.12.007] [Citation(s) in RCA: 9] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/02/2022] [Revised: 11/22/2022] [Accepted: 12/10/2022] [Indexed: 12/23/2022]
Abstract
The objective of the present study was to determine the problems and information needs of patients with bipolar disorder during the treatment process. The present research is in the type of descriptive and qualitative study. In-depth individual interviews were conducted with 11 volunteer patients with bipolar disorder. The data collected from the interviews were evaluated using the descriptive analysis method. In the study, four categories (disease onset/diagnosis stage, adherence to treatment, interpersonal relationships, information needs) and nine main themes (symptoms, family support, factors that positively affect treatment adherence, factors that negatively affect treatment adherence, positive effects of treatment, negative effects of treatment, stigmatization, treatment, disease) were determined. Patients with bipolar disorder can be helped to cope with the problems they experience by providing information about the disease, adherence to treatment, the treatment process, and the effects of drugs.
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Affiliation(s)
- Ebru Başkaya
- Uşak University, Vocational School of Health Services, Department of Health Care Services, Uşak, Turkey.
| | - Satı Demir
- Gazi University, Faculty of Health Sciences, Department of Psychiatric Nursing, Ankara, Turkey
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Moulaei K, Bahaadinbeigy K, Mazhari S. Designing the minimum data set of bipolar disorder: A basis for introducing the effective factors in managing, controlling, and monitoring the bipolar disorder. JOURNAL OF EDUCATION AND HEALTH PROMOTION 2022; 11:147. [PMID: 35847134 PMCID: PMC9277744 DOI: 10.4103/jehp.jehp_971_21] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 07/02/2021] [Accepted: 08/09/2021] [Indexed: 06/15/2023]
Abstract
BACKGROUND AND AIM Bipolar disorder (BD) is one of the most challenging psychiatric disorders in the management area that can lead to functional, occupational, and cognitive disorders. Without proper care, this complication can lead to profound psychological challenges and even death. The aim of this study is to design a minimum data set (MDS) for BD. MATERIALS AND METHODS This descriptive cross-sectional study was conducted in two steps. In the first step, a survey was conducted in PubMed, Web of Science, and SCOPUS databases to identify the demographic, managerial, and clinical data elements. Then, the required data elements were extracted from the studies by the data extraction form and used in a questionnaire. In the second step, to confirm the data element set, the designed questionnaire was distributed and collected among 20 psychiatrists and subspecialists during a two-stage Delphi technique. Descriptive statistics (frequency and mean) were conducted to analyze the data. RESULTS Totally, 112 managerial and clinical data elements in 14 categories were extracted from the studies. Based on the experts' opinion and their consensus, 88 necessary data elements were considered to bipolar MDS. "Medication nonadherence," "history of suicide," and "substance abuse and addiction" were the most important data elements. CONCLUSION In this study, an MDS was designed for BD. Providing this MDS, in addition to improving the clinical processes, it is possible to help electronic system designers and health data managers to know what information should be included in the health systems or any kind of self-care or self-management software to meet the information needs of these patients.
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Affiliation(s)
- Khadijeh Moulaei
- Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
| | - Kambiz Bahaadinbeigy
- Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran
| | - Shahrzad Mazhari
- Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran
- Department of Psychiatry, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran
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A pilot trial of quetiapine, lithium, or placebo added to divalproex sodium for hypomanic or manic episodes in ambulatory adults with bipolar I disorder. Int J Bipolar Disord 2022; 10:7. [PMID: 35235061 PMCID: PMC8891404 DOI: 10.1186/s40345-022-00252-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2021] [Accepted: 01/18/2022] [Indexed: 11/10/2022] Open
Abstract
Background Many patients with bipolar I disorder do not respond to monotherapy treatment with mood-stabilizing medications, and combination regimens are commonly used in both inpatient and outpatient settings for the acute and maintenance treatment of bipolar disorder. We studied whether combination therapy is more effective than monotherapy for the acute treatment of subjects with bipolar I disorder currently experiencing manic symptoms. The primary hypothesis was that combination treatments would be associated with greater reductions in symptoms of mania and hypomania than monotherapy alone. The secondary hypothesis was that combination therapies would be associated with lower depression levels than monotherapy alone. Last, a post-hoc exploratory aim was used to examine whether the effect of side effect severity on risk-of-dropout would be greater in combination therapies than in monotherapy alone. Results In this 12-week, double-blind, placebo-controlled ambulatory pilot trial, participants (n = 75) with bipolar I disorder were randomly assigned to: (1) monotherapy divalproex plus placebo (DVP + PBO), (2) combination therapy of divalproex plus blinded lithium (DVP + Li) or (3) divalproex plus blinded quetiapine (DVP + QTP). Combination therapies (vs. monotherapy) were not associated with improved symptoms of mania, hypomania or depression. The effect of side effect severity on study retention did not differ between combination therapies and monotherapy. However, the risk-of-dropout was significantly greater in the DVP + Li arm versus the DVP + PBO arm. Conclusions No longitudinal differences in mania, hypomania or depression were found between combination therapies and monotherapy. The effect of side effect severity on study retention did not differ between groups. Due to the small sample size and differential rates of attrition between treatment arms, results of this pilot trial must be interpreted with caution. Trial registration ClinicalTrials.gov identifier: NCT00183443
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Levenberg K, Edris W, Levine M, George DR. Considering a Potential Role of Linalool as a Mood Stabilizer for Bipolar Disorder. Curr Pharm Des 2020; 26:5128-5133. [PMID: 32713332 DOI: 10.2174/1381612826666200724160742] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2020] [Accepted: 07/28/2020] [Indexed: 12/18/2022]
Abstract
Epidemiologic studies suggest that the lifetime prevalence of bipolar spectrum disorders ranges from 2.8 to 6.5 percent of the population. To decrease morbidity and mortality associated with disease progression, pharmacologic intervention is indicated for the majority of these patients. While a number of effective treatment regimens exist, many conventional medications have significant side effect profiles that adversely impact patients' short and long-term well-being. It is thus important to continue advancing and improving therapeutic options available to patients. This paper reviews the limitations of current treatments and examines the chemical compound Linalool, an alcohol found in many plant species, that may serve as an effective mood stabilizer. While relatively little is known about Linalool and bipolar disorder, the compound has been shown to have antiepileptic, anti-inflammatory, anxiolytic, anti-depressive, and neurotrophic effects, with mechanisms that are comparable to current bipolar disorder treatment options.
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Affiliation(s)
- Kate Levenberg
- College of Medicine, Penn State University College of Medicine, State College, Hershey, United States
| | - Wade Edris
- Department of Medicine, Penn State University College of Medicine, State College, Hershey, United States
| | - Martha Levine
- Department of Pediatrics, Penn State University College of Medicine, Hershey, United States
| | - Daniel R George
- Department of Pediatrics, Penn State University College of Medicine, Hershey, United States
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Narayanan D, Jith A, Bansal R. Nonadherence in bipolar disorder patients: A 14-year retrospective study. Indian J Psychiatry 2020; 62:290-294. [PMID: 32773872 PMCID: PMC7368454 DOI: 10.4103/psychiatry.indianjpsychiatry_357_19] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/13/2019] [Revised: 10/03/2019] [Accepted: 01/02/2020] [Indexed: 11/24/2022] Open
Abstract
BACKGROUND Bipolar disorder is a disabling psychiatric disorder. The existing literature suggests about 41% of patients to be nonadherent. Nonadherence leads to relapses, delay in recovery besides higher inpatient care cost as well as higher global cost of the disease. Nonadherence in bipolar affective disorder (BPAD) is a complex phenomenon, its critical determinants are yet to be identified with certainty. AIMS This study aims to assess the prevalence of nonadherence in BPAD and to delineate the factors associated with it. METHODS Medical records were reviewed in this study from 2005 to 2019 at a medical college in Kerala. Patients who were diagnosed with BPAD according to International Classification of Diseases 10 and who were needing or opting for prophylaxis were included. Patients who were not taking medications for at least 1 week were termed as nonadherent. We included 150 participants in our study. RESULTS To test the statistical significance of the association of categorical variables between H/O of adherence and nonadherence, Chi-square test was used. In the sample, 82.7% had at least 1 week of history of noncompliance in the past. The most common reason was poor understanding of illness by the family (56%) followed by a negative aspect of the patient toward the drug (20%). CONCLUSION Therefore, this study concludes that though majority of the patients have a history of nonadherence of at least 1 week on long-term follow-up, it was seen that majority of the patients were more than 80% adherent to medications.
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Affiliation(s)
- Dinesh Narayanan
- Department of Psychiatry, Amrita Institute of Medical Sciences, Kochi, Kerala, India
| | - Arya Jith
- Department of Psychiatry, Amrita Institute of Medical Sciences, Kochi, Kerala, India
| | - Rahul Bansal
- Department of Psychiatry, Amrita Institute of Medical Sciences, Kochi, Kerala, India
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Inder M, Lacey C, Crowe M. Participation in decision-making about medication: A qualitative analysis of medication adherence. Int J Ment Health Nurs 2019; 28:181-189. [PMID: 29956441 DOI: 10.1111/inm.12516] [Citation(s) in RCA: 12] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 06/11/2018] [Indexed: 12/28/2022]
Abstract
Rates of relapse in BD are high with medication nonadherence identified as an important contributor to relapse. Psychopharmacology remains a key component to the treatment of BD; therefore, increased understanding of medication use and ways to promote greater adherence is essential. The aim of the study was to identify how participants with BD experience taking prescribed medication. Participants had BD I or BD II, were users of specialist mental health services, aged 18-64 years, euthymic, mildly hypomanic or depressed, and on any combination of medication. Exclusion criteria were minimal. A semistructured interview was completed exploring patients' views of BD and factors influencing adherence based on the Subjective Experience of Medication Interview. An inductive thematic analysis was used to identify themes. The study participants (n = 36) had predominantly bipolar I (78%) and were female (69%), and of New Zealand European ethnicity (67%) with 14% Maori. The mean age was 41 years (SD: 12.0). Findings from the thematic analysis generated three themes: Learning about the clinical meaning of having BD, Understanding how to use medication, and Understanding what works for me. The qualitative nature of our study limits the generalizability of our findings to a broader population of individuals with BD. The participants developed confidence in being in charge of their BD through a process of learning about BD and medication and understanding what this meant for them. The findings support greater emphasis on collaborative approaches that recognize the expertise of the individual with BD and the clinician.
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Affiliation(s)
- Maree Inder
- Department of Psychological Medicine, University of Otago, Christchurch, New Zealand
| | - Cameron Lacey
- Department of Psychological Medicine, University of Otago, Christchurch, New Zealand
| | - Marie Crowe
- Department of Psychological Medicine, University of Otago, Christchurch, New Zealand
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Selvakumar N, Menon V, Kattimani S. A Cross-sectional Analysis of Patterns and Predictors of Medication Adherence in Bipolar Disorder: Single Center Experience from South India. CLINICAL PSYCHOPHARMACOLOGY AND NEUROSCIENCE 2018; 16:168-175. [PMID: 29739130 PMCID: PMC5953016 DOI: 10.9758/cpn.2018.16.2.168] [Citation(s) in RCA: 18] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Received: 01/25/2017] [Revised: 03/10/2017] [Accepted: 04/03/2017] [Indexed: 01/23/2023]
Abstract
Objective Our objective was to determine patterns and predictors of medication adherence in bipolar disorder. Methods Between August 2015 and December 2016, we recruited 160 patients with a diagnosis of bipolar disorder as per International Classification of Diseases-10: Clinical Descriptions and Diagnostic Guidelines. The diagnosis was further confirmed by using the MINI International Neuropsychiatric Inventory. All of them were currently in remission (confirmed by standard measures) and on stable dosing of medication for at least a year. Medication adherence was assessed using Tamil validated version of Morisky Medication Adherence Scale. Patients were dichotomized into low adherence (<6) and high adherence (≥6) groups and compared on various socio-demographic and clinical variables. Results Majority of the sample (n=97, 60.6%) demonstrated low adherence to treatment regimen. Being employed and having spent greater number of days in hospital were predictive of higher medication adherence (odds ratio [OR] 2.78, 95% confidence interval [CI] 1.019-7.585; and OR 1.02, 95% CI 1.003-1.037, respectively). Fewer number of lifetime depressive episodes and positive drug attitudes demonstrated trend level positive association with high medication adherence. Conclusion Non-adherence to prescribed medications is a common problem in bipolar disorder. Interventions targeting vocation, medication focused psychoeducation and promotion of positive drug attitudes are likely to enhance medication adherence in this group.
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Affiliation(s)
- Nivedhitha Selvakumar
- Department of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India
| | - Vikas Menon
- Department of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India
| | - Shivan Kattimani
- Department of Psychiatry, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India
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A study of the real-world effectiveness of group psychoeducation for bipolar disorders: Is change in illness perception a key mediator of benefit? J Affect Disord 2018; 227:713-720. [PMID: 29179141 DOI: 10.1016/j.jad.2017.11.072] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/19/2017] [Revised: 09/25/2017] [Accepted: 11/12/2017] [Indexed: 02/07/2023]
Abstract
BACKGROUND Findings from efficacy trials of group psychoeducation (PE) for bipolar disorders (BD) led to its inclusion in evidence-based guidelines as a first-line mandatory treatment. However, pragmatic trials and observational studies are needed to determine its real-world effectiveness, impact on outcomes deemed important to patients and to clarify potential mediators of any benefits. METHODS Individuals with BD were offered the opportunity to participate in 20h of PE and asked to complete pre- and post-intervention ratings of symptoms, knowledge about BD, medication adherence, and illness perception. A priori, two key patient outcomes were identified (social functioning and self-esteem); sample attrition due to dropout or relapse was recorded. RESULTS Of 156 individuals who completed the pre-PE assessments, 103 completed the program and post-PE assessments. Only 4 of 53 dropouts were associated with BD relapse. Post-intervention, the PE completers demonstrated a statistically significant improvement in social functioning (p = 0.003, Effect Size (ES) = 0.26) and a trend towards improved self-esteem (ES = 0.14). Whilst there were significant changes in medication adherence (p = 0.002, ES = 0.28), knowledge of BD (p < 0.001, ES = 1.20), and illness perception (p < 0.001, ES = -0.37), mediational analysis demonstrated that only change in illness perception was associated to change in functioning (p=0.03) with no contribution from changes in knowledge of BD or medication adherence. CONCLUSIONS In real-world settings, over 60% individuals completed 10-session course of PE. After controlling for demography and baseline clinical state, change in illness perception, rather than change in knowledge or medication adherence, emerged as a potential mediator of some benefits of PE.
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Homework in Cognitive Behavioral Therapy: A Systematic Review of Adherence Assessment in Anxiety and Depression (2011-2016). Psychiatr Clin North Am 2017; 40:625-639. [PMID: 29080590 DOI: 10.1016/j.psc.2017.08.001] [Citation(s) in RCA: 42] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
Treatment adherence has posed a substantial challenge not only for patients but also for the health profession for many decades. The last 5 years has witnessed significant attention toward adherence with cognitive behavioral therapy (CBT) homework for anxiety and depressive disorders, and adherence assessment methods have diversified. However, there remains a large component of the adherence process not assessed in CBT, with patient effort, engagement, and the known role for treatment appraisals and beliefs necessitating the pursuit of improved adherence assessment methods.
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Chakrabarti S. Medication non-adherence in bipolar disorder: Review of rates, demographic and clinical predictors. World J Meta-Anal 2017; 5:103. [DOI: 10.13105/wjma.v5.i4.103] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/28/2017] [Revised: 04/24/2017] [Accepted: 06/13/2017] [Indexed: 02/06/2023] Open
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Chakrabarti S. Treatment-adherence in bipolar disorder: A patient-centred approach. World J Psychiatry 2016; 6:399-409. [PMID: 28078204 PMCID: PMC5183992 DOI: 10.5498/wjp.v6.i4.399] [Citation(s) in RCA: 74] [Impact Index Per Article: 8.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/17/2016] [Revised: 10/31/2016] [Accepted: 11/22/2016] [Indexed: 02/05/2023] Open
Abstract
About half of the patients diagnosed with bipolar disorder (BD) become non-adherent during long-term treatment, a rate largely similar to other chronic illnesses and one that has remained unchanged over the years. Non-adherence in BD is a complex phenomenon determined by a multitude of influences. However, there is considerable uncertainty about the key determinants of non-adherence in BD. Initial research on non-adherence in BD mostly limited itself to examining demographic, clinical and medication-related factors impacting adherence. However, because of inconsistent results and failure of these studies to address the complexities of adherence behaviour, demographic and illness-related factors were alone unable to explain or predict non-adherence in BD. This prompted a shift to a more patient-centred approach of viewing non-adherence. The central element of this approach includes an emphasis on patients’ decisions regarding their own treatment based on their personal beliefs, life circumstances and their perceptions of benefits and disadvantages of treatment. Patients’ decision-making processes are influenced by the nature of their relationship with clinicians and the health-care system and by people in their immediate environment. The primacy of the patient’s perspective on non-adherence is in keeping with the current theoretical models and concordance-based approaches to adherence behaviour in BD. Research over the past two decades has further endorsed the critical role of patients’ attitudes and beliefs regarding medications, the importance of a collaborative treatment-alliance, the influence of the family, and the significance of other patient-related factors such as knowledge, stigma, patient satisfaction and access to treatment in determining non-adherence in BD. Though simply moving from an illness-centred to a patient-centred approach is unlikely to solve the problem of non-adherence in BD, such an approach is more likely to lead to a better understanding of non-adherence and more likely to yield effective solutions to tackle this common and distressing problem afflicting patients with BD.
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Nordon C, Karcher H, Groenwold RHH, Ankarfeldt MZ, Pichler F, Chevrou-Severac H, Rossignol M, Abbe A, Abenhaim L. The "Efficacy-Effectiveness Gap": Historical Background and Current Conceptualization. VALUE IN HEALTH : THE JOURNAL OF THE INTERNATIONAL SOCIETY FOR PHARMACOECONOMICS AND OUTCOMES RESEARCH 2016; 19:75-81. [PMID: 26797239 DOI: 10.1016/j.jval.2015.09.2938] [Citation(s) in RCA: 111] [Impact Index Per Article: 12.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/20/2015] [Revised: 09/01/2015] [Accepted: 09/30/2015] [Indexed: 05/22/2023]
Abstract
BACKGROUND The concept of the "efficacy-effectiveness gap" (EEG) has started to challenge confidence in decisions made for drugs when based on randomized controlled trials alone. Launched by the Innovative Medicines Initiative, the GetReal project aims to improve understanding of how to reconcile evidence to support efficacy and effectiveness and at proposing operational solutions. OBJECTIVES The objectives of the present narrative review were 1) to understand the historical background in which the concept of the EEG has emerged and 2) to describe the conceptualization of EEG. METHODS A focused literature review was conducted across the gray literature and articles published in English reporting insights on the EEG concept. The identification of different "paradigms" was performed by simple inductive analysis of the documents' content. RESULTS The literature on the EEG falls into three major paradigms, in which EEG is related to 1) real-life characteristics of the health care system; 2) the method used to measure the drug's effect; and 3) a complex interaction between the drug's biological effect and contextual factors. CONCLUSIONS The third paradigm provides an opportunity to look beyond any dichotomy between "standardized" versus "real-life" characteristics of the health care system and study designs. Namely, future research will determine whether the identification of these contextual factors can help to best design randomized controlled trials that provide better estimates of drugs' effectiveness.
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Affiliation(s)
| | | | - Rolf H H Groenwold
- Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands
| | | | | | | | - Michel Rossignol
- Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada
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Porzsolt F, Rocha NG, Toledo-Arruda AC, Thomaz TG, Moraes C, Bessa-Guerra TR, Leão M, Migowski A, Araujo da Silva AR, Weiss C. Efficacy and effectiveness trials have different goals, use different tools, and generate different messages. Pragmat Obs Res 2015; 6:47-54. [PMID: 27774032 PMCID: PMC5045025 DOI: 10.2147/por.s89946] [Citation(s) in RCA: 42] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/15/2022] Open
Abstract
The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe.
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Affiliation(s)
- Franz Porzsolt
- Health Care Research, Department of General and Visceral Surgery, University Hospital Ulm, Ulm, Germany
- Institute of Clinical Economics (ICE) eV, Ulm, Germany
| | - Natália Galito Rocha
- Department of Physiology and Pharmacology, Biomedical Institute, Universidade Federal Fluminense, Niterói
| | - Alessandra C Toledo-Arruda
- Department of Physiology and Pharmacology, Biomedical Institute, Universidade Federal Fluminense, Niterói
| | - Tania G Thomaz
- Department of Physiology and Pharmacology, Biomedical Institute, Universidade Federal Fluminense, Niterói
- Cardiovascular Sciences, Universidade Federal Fluminense, Niterói
| | - Cristiane Moraes
- Cardiovascular Sciences, Universidade Federal Fluminense, Niterói
| | | | - Mauricio Leão
- Institute of Nuclear Medicine, University Hospital Antonio Pedro, Niterói
| | - Arn Migowski
- National Cancer Institute (INCA), Rio de Janeiro, Brazil
- National Institute of Cardiology (INC), Rio de Janeiro, Brazil
| | - André R Araujo da Silva
- Department of Mother and Child, Faculty of Medicine, Universidade Federal Fluminense, Niterói, Rio de Janeiro, Brazil
| | - Christel Weiss
- Institute of Clinical Economics (ICE) eV, Ulm, Germany
- Department of Medical Statistics, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany
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Trajectories of medication attitudes and adherence behavior change in non-adherent bipolar patients. Compr Psychiatry 2015; 58:29-36. [PMID: 25617964 PMCID: PMC4369431 DOI: 10.1016/j.comppsych.2014.11.023] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/01/2014] [Revised: 11/26/2014] [Accepted: 11/27/2014] [Indexed: 02/04/2023] Open
Abstract
OBJECTIVES While medication treatment is necessary for the successful management of bipolar disorder (BD), non-adherence rates are up to 60%. Although medication attitudes are believed to be relevant to adherence behavior, few studies have investigated the trajectories of adherence change. This study evaluated attitudinal correlates of adherence conversion in 86 poorly adherent individuals with BD. METHODS This secondary analysis pooled data from two uncontrolled prospective trials of customized adherence enhancement (CAE), a psychosocial intervention delivered over 4-6 weeks. Poor adherence was defined as missing at least 20% of prescribed BD medication based on the self-reported Tablets Routine Questionnaire (TRQ). The sample was dichotomized into converters who achieved good adherence (N=44) and non-converters who remained poorly adherent (N=21). Converters vs. non-converters were compared on adherence, attitudes, and symptoms at baseline, 6 weeks and 3 months. RESULTS At baseline, converters and non-converters were similar demographically and clinically, but converters were less non-adherent (32% doses missed) than non-converters (59% missed). At 6 weeks, converters had better attitudes than non-converters. At 3 months, converters maintained improvements, but group differences were less pronounced due to some improvement in non-converters. Converters had better adherence at 3 months and trajectories differed for the groups on attitudes. Symptoms gradually improved for both converters and non-converters. CONCLUSIONS Over two-thirds of poorly adherent BD patients who received CAE converted to good adherence. Improved medication attitudes may be a driver of improved adherence behavior and ultimately reduce BD symptoms.
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Jacob SA, Ab Rahman AF, Hassali MAA. Attitudes and beliefs of patients with chronic depression toward antidepressants and depression. Neuropsychiatr Dis Treat 2015; 11:1339-47. [PMID: 26064052 PMCID: PMC4455848 DOI: 10.2147/ndt.s82563] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/03/2022] Open
Abstract
BACKGROUND Many patients have erroneous views with regard to depression and its management, and it was noted that these attitudes and beliefs significantly affected their adherence rates. OBJECTIVES The primary aim of this study was to determine the attitudes and beliefs of patients with depression toward depression and antidepressants. A secondary aim was to assess the influence of ethnicity on patients' attitudes and beliefs. PATIENTS AND METHODS The study involved patients with chronic depression being followed up at an outpatient clinic at a government-run hospital in Malaysia. Patients' attitudes and beliefs were assessed using the Antidepressant Compliance Questionnaire. RESULTS A total of 104 patients of Malay, Chinese, and Indian ethnic groups met the selection criteria. Chinese patients had significantly negative attitudes and beliefs toward depression and antidepressants compared to Malays and Indians (b=-8.96, t 103=-3.22; P<0.05). Component analysis revealed that 59% of patients believed that antidepressants can cause a person to have less control over their thoughts and feelings, while 67% believed that antidepressants could alter one's personality; 60% believed it was okay to take fewer tablets on days when they felt better, while 66% believed that antidepressants helped solve their emotional problems and helped them worry less. CONCLUSION Patients had an overall positive view as to the benefits of antidepressants, but the majority had incorrect views as to the acceptable dosing of antidepressants and had concerns about the safety of the medication. Assessing patients' attitudes and beliefs, as well as the impact of their respective cultures, can be used in tailoring psychoeducation sessions accordingly.
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Affiliation(s)
| | - Ab Fatah Ab Rahman
- Faculty of Health Sciences, Gong Badak Campus, Universiti Sultan Zainal Abidin (UniSZA), Kuala Terengganu, Malaysia
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Vargas-Huicochea I, Huicochea L, Berlanga C, Fresán A. Taking or not taking medications: psychiatric treatment perceptions in patients diagnosed with bipolar disorder. J Clin Pharm Ther 2014; 39:673-9. [PMID: 25252225 DOI: 10.1111/jcpt.12210] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/02/2014] [Accepted: 08/25/2014] [Indexed: 01/18/2023]
Abstract
WHAT IS KNOWN AND OBJECTIVE Bipolar disorder is a common and disabling condition. Although its negative impact may be limited in some way by the use of different treatment options, lack of adherence to psychiatric treatment is still an obstacle to overcome. Because there are many factors involved in non-adherence to treatment, in this study, we sought to examine the subjective aspect of this phenomenon. We analysed perceptions of both the disease and the treatment in a group of patients with bipolar disorder. METHODS We incorporated a qualitative design that included 50 outpatients diagnosed with bipolar disorder type 1. Through semi-structured interviews, we explored patients' perceptions of bipolarity and psychiatric medication management. RESULTS AND DISCUSSION The participants reported the use of medications as one of the most troubling aspects of having bipolar disorder. The fear of becoming addicted to psychiatric drugs was repeatedly mentioned among the patients as an argument for abandoning treatment. The main expectation of treatment was to achieve stable mood, but the patients considered that drugs were not the only way to be euthymic. WHAT IS NEW AND CONCLUSIONS The patients expressed ambivalence between the need to take medication to remain stable and the fear of negative consequences of using psychiatric drugs. Personal beliefs and environmental influences seem to determine each individual's final choice of whether to maintain or discontinue treatment; so, in everyday clinical practice, it would be necessary to discuss perceptions of the disease with patients and their families.
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Affiliation(s)
- I Vargas-Huicochea
- Sub-dirección de Investigaciones Clínicas, Instituto Nacional de Psiquiatría "Ramón de la Fuente", Mexico City, Mexico
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The utilization of psychopharmacological treatment and medication adherence among Medicaid enrolled children and adolescents with bipolar depression. J Affect Disord 2013; 150:424-9. [PMID: 23747210 DOI: 10.1016/j.jad.2013.04.034] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2013] [Accepted: 04/26/2013] [Indexed: 11/23/2022]
Abstract
BACKGROUND To examine the psychotropic medication utilization and compare adherence to treatment regimens in pediatric bipolar depression patients. METHODS 2003-2007 MAX data from four geographically diverse states were used. According to the regimen received by the patients (6-18 years) in the first month after the index bipolar depression diagnosis, patients were categorized into six mutually exclusive groups. The month to month change of treatment regimen in each group was then assessed during the 6 month post-index bipolar depression diagnosis. Adherence to each regimen was measured as continuation of the initial regimen, switch to a new regimen, augmentation with medication from a different therapeutic category, and discontinuation of all pharmacotherapies. Repeated measure analysis was conducted to compare the trend of each adherence measure across the study groups. RESULTS Of the 5,460 subjects identified, 15.39% received antipsychotic monotherapy, 9.43% received mood stabilizer monotherapy, 5.77% received antidepressant monotherapy, 26.48% received mood stabilizer-antipsychotic polytherapy, 22.51% received antidepressant polytherapy, and 19.89% received antipsychotic-mood stabilizer-antidepressant polytherapy. At the end of the follow-up period, over 50% of the 1st month polytherapy users and less than 50% of the monotherapy users were continuing their initial regimen. Repeated measure analysis using antipsychotic monotherapy as the reference group suggested differences in trend slopes (p<0.05). LIMITATIONS In absence of structured clinical evaluation, bipolar disorder diagnoses cannot be ascertained in this study. CONCLUSIONS Bipolar depression patients were predominantly treated with combinations of psychotropic drugs. Potentially questionable practice, such as antidepressant monotherapy was used only in a small fraction of patients. Combination regimens had better adherence as compared to monotherapies.
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Abstract
In psychiatry, one of the main factors contributing to poor response to pharmacological treatment is adherence. Noncompliance with maintenance treatments for chronic illnesses such as schizophrenia and affective disorders can exceed 50%, Poor adherence can be due to drug-related factors (tolerance, complexity of prescription, side effects, or cost), patient-related variables (illness symptoms, comorbidity, insight capacity, belief system, or sociocultural environment), and physician-related factors (communication or psychoeducational style). Psychosocial treatments must be used in conjunction with medication during the maintenance phase to improve adherence to treatment and to achieve - through the management of psychological variables - better social, work, and family functioning. This article reviews the concepts of adherence and noncompliance, and their impact on maintenance treatments, as well as the effect of dealing with psychosocial factors in psychiatric treatment.
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Affiliation(s)
- César Carvajal
- Professor of Psychiatry, Faculty of Medicine, Universiclacl de los Andes, and Hospital del Trabajador Santiago, Chile
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Crowe M, Porter R, Inder M, Lacey C, Carlyle D, Wilson L. Effectiveness of interventions to improve medication adherence in bipolar disorder. Aust N Z J Psychiatry 2012; 46:317-26. [PMID: 22508592 DOI: 10.1177/0004867411428101] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
OBJECTIVE To identify interventions that improve medication adherence in bipolar disorder. METHOD A review of the literature from 2004 to 2011 was conducted using Medline and manual searching. RESULTS Eleven studies were identified as meeting inclusion criteria. Five studies demonstrated improved medication adherence. No characteristics of the interventions, clinical characteristics of the groups or methodological factors distinguished those psychosocial interventions that demonstrated improvement from those that did not. CONCLUSIONS While only a few interventions improved adherence, most improved clinical outcomes. Issues were also identified about the way in which adherence is defined. It is proposed that incorporating patient preferences into measures of adherence within the context of a disorder-specific psychosocial intervention may provide an approach that demonstrates both improved adherence and improved clinical outcomes. However this requires further research.
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Affiliation(s)
- Marie Crowe
- Department of Psychological Medicine, University of Otago, New Zealand.
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Lobban F, Solis-Trapala I, Tyler E, Chandler C, Morriss RK. The Role of Beliefs About Mood Swings in Determining Outcome in Bipolar Disorder. COGNITIVE THERAPY AND RESEARCH 2012. [DOI: 10.1007/s10608-012-9452-9] [Citation(s) in RCA: 17] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
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Zeber JE, Miller AL, Copeland LA, McCarthy JF, Zivin K, Valenstein M, Greenwald D, Kilbourne AM. Medication adherence, ethnicity, and the influence of multiple psychosocial and financial barriers. ADMINISTRATION AND POLICY IN MENTAL HEALTH AND MENTAL HEALTH SERVICES RESEARCH 2011; 38:86-95. [PMID: 20549327 DOI: 10.1007/s10488-010-0304-1] [Citation(s) in RCA: 25] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
Medication adherence is critical for patients with bipolar disorder to avoid symptom exacerbation and diminished quality of life. Most analyses consider adherence barriers individually rather than conjointly, while neglecting potential ethnic differences. 435 patients in the Continuous Improvement for Veterans in Care--Mood Disorders study reported multiple financial and psychosocial factors influencing adherence. Logistic regression modeled adherence as a function of perceived barriers, including cost burden, access, binge drinking, poor therapeutic alliance, and medication beliefs. Nearly half the cohort experienced adherence difficulty, averaging 2.8 barriers, with minority veterans reporting lower adherence than white patients, particularly financial burden and treatment access. Total barriers were significantly associated with worse adherence (OR = 1.24 per barrier), notably poor medication beliefs, binge drinking, and difficulty accessing psychiatric specialists (ORs of 2.41, 1.95 and 1.73, respectively). Veterans with bipolar disorder experience numerous adherence barriers, with certain obstacles proving especially pernicious. Fortunately tailored clinical interventions can improve adherence, particularly by addressing modifiable risk factors.
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Affiliation(s)
- John E Zeber
- Veterans Affairs HSR&D: South Texas Veterans Health Care System (VERDICT), 7400 Merton Minter Boulevard, San Antonio, TX 78229-4404, USA.
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Patients' reports of the factors influencing medication adherence in bipolar disorder - an integrative review of the literature. Int J Nurs Stud 2011; 48:894-903. [PMID: 21481391 DOI: 10.1016/j.ijnurstu.2011.03.008] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2010] [Revised: 01/24/2011] [Accepted: 03/11/2011] [Indexed: 12/16/2022]
Abstract
BACKGROUND As with other long-term conditions patients with bipolar disorder are rarely totally adherent or non-adherent. Rates of non-adherence have not changed since the first introduction of psychotropic medications in the 1950s despite vast numbers of new compounds being marketed. Non-adherence with medication in bipolar disorder is associated with affective relapse and consequently poor quality of life. The reasons that patients are non-adherent with medication are not well understood by clinicians who often assume it is related to the illness itself. OBJECTIVES To identify patients' perceptions of medication adherence in bipolar disorder. DESIGN An integrated review of the literature published between 1999 and 2010. DATA SOURCES Ovid (Medline, CINAHL, Embase, PsycINFO) and manual searching. REVIEW METHODS An integrative review of the literature was conducted which included: (a) problem formation, (b) literature search and initial screening, (c) gathering data from studies, (d) evaluating study quality, (e) data analysis and integration, (f) data interpretation, and (g) presentation of the findings. RESULTS Thirteen articles met criteria for inclusion in the review. These articles identified how patients reported their perceptions on medication and were integrated into four categories: illness factors, personal attitudes and beliefs, medication factors and environmental factors. CONCLUSIONS These findings suggest a need to address adherence from the full range of influencing factors (patient, illness, medication and environmental). Clinicians need to utilise a collaborative approach to working together with patients in order to identify the meaning that patients attribute to the symptoms, diagnosis, prognosis and medication. Understanding patients' perceptions and accepting these may facilitate greater medication adherence and the consequent improved clinical outcomes for patients with bipolar disorder.
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Narasimhan M, Hardeman SM, Johnson AM. Nonadherence in mood disorders: A formidable challenge in clinical practice. Asian J Psychiatr 2011; 4:22-5. [PMID: 23050910 DOI: 10.1016/j.ajp.2010.10.005] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2010] [Revised: 09/23/2010] [Accepted: 10/10/2010] [Indexed: 01/09/2023]
Abstract
Nonadherence in mood disorders poses a significant obstacle to remission and recovery. A comprehensive approach that includes evidence-based strategies have been shown to improve adherence customized to the individual needs of the patient resulting in improved quality of life and reduced disease burden. This is further strengthened by identifying risk factors, establishing therapeutic alliances, and educating patients, families and other healthcare providers.
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Affiliation(s)
- Meera Narasimhan
- Department of Neuropsychiatry, University of South Carolina School of Medicine, Columbia, SC, USA
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Hardeman SM, Narasimhan M. Adherence according to Mary Poppins: strategies to make the medicine go down. Perspect Psychiatr Care 2010; 46:3-13. [PMID: 20051074 DOI: 10.1111/j.1744-6163.2009.00233.x] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/20/2023] Open
Abstract
PURPOSE This article reviews the prevalence, risk factors, and burden of nonadherence in mood and psychotic disorders, and presents evidence-based, disease-specific strategies shown to improve adherence. CONCLUSION A comprehensive approach based on the goal of remission, designed around the patient's individual needs, facilitates adherence, leads to improved quality of life, and reduces disease burden. PRACTICE IMPLICATIONS Adherence in mood and psychotic disorders can be improved when providers take time to build trusting relationships; identify risk factors; anticipate nonadherence; individualize treatment; and educate patients, families, and other healthcare providers.
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Affiliation(s)
- Suzanne M Hardeman
- Division of Biological Research and Department of Neuropsychiatry and Behavioral Science, University of South Carolina School of Medicine, Columbia, SC, USA.
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Clatworthy J, Bowskill R, Parham R, Rank T, Scott J, Horne R. Understanding medication non-adherence in bipolar disorders using a Necessity-Concerns Framework. J Affect Disord 2009; 116:51-5. [PMID: 19101038 DOI: 10.1016/j.jad.2008.11.004] [Citation(s) in RCA: 83] [Impact Index Per Article: 5.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/16/2008] [Revised: 11/06/2008] [Accepted: 11/06/2008] [Indexed: 12/17/2022]
Abstract
BACKGROUND Medication non-adherence is a major problem in patients with severe mental disorders and is associated with poor clinical outcomes and high resource utilization. This study examined the utility of the Necessity-Concerns Framework for understanding patient attitudes towards and levels of adherence with medications prescribed for bipolar disorders. METHOD A convenience sample of 223 individuals currently prescribed medication for bipolar disorders, recruited by advertisement in a Manic Depression Fellowship newsletter, completed the Beliefs about Medication Questionnaire and the Medication Adherence Report Scale. RESULTS Low adherence was reported by 30% (n=64) and was predicted by greater doubts about personal need for treatment (OR=.50; 95% CI: .31-.82) and stronger concerns about potential negative effects (OR=2.00; 95% CI: 1.20-3.34). These predictors were independent of current mood state, illness and demographic characteristics. LIMITATIONS Participants were a potentially biased sample of volunteers who had been recruited through a patient organisation newsletter. However, clinical characteristics and adherence rates in this study were similar to those reported in other studies conducted in Europe and the USA. CONCLUSIONS The Necessity-Concerns Framework is a useful theoretical model for understanding key attitudes towards medication in bipolar disorders. Interventions to facilitate adherence should elicit and address patients' beliefs about medication.
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Affiliation(s)
- Jane Clatworthy
- Centre for Behavioural Medicine, School of Pharmacy, University of London, UK
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Sajatovic M, Ignacio RV, West JA, Cassidy KA, Safavi R, Kilbourne AM, Blow FC. Predictors of nonadherence among individuals with bipolar disorder receiving treatment in a community mental health clinic. Compr Psychiatry 2009; 50:100-7. [PMID: 19216885 PMCID: PMC2746444 DOI: 10.1016/j.comppsych.2008.06.008] [Citation(s) in RCA: 108] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2007] [Revised: 06/12/2008] [Accepted: 06/19/2008] [Indexed: 12/17/2022] Open
Abstract
BACKGROUND Subjective experience of illness is a critical component of treatment adherence in populations with bipolar disorder (BPD). This cross-sectional analysis examined clinical and subjective variables in relation to adherence in 140 individuals with BPD receiving treatment with mood-stabilizing medication. METHODS Nonadherence was defined as missing 30% or more of medication on the Tablets Routine Questionnaire, a self-reported measure of medication treatment adherence. Adherent and nonadherent groups were compared on measures of attitudes toward illness and treatment including the Attitudes toward Mood Stabilizers Questionnaire, the Insight and Treatment Attitudes Questionnaire, the Rating of Medication Influences, and the Multidimensional Health Locus of Control Scale. RESULTS Except for substance abuse comorbidity, adherent individuals (n = 113, 80.7%) did not differ from nonadherent individuals (n = 27, 19.3%) on clinical variables. However, nonadherent individuals had reduced insight into illness, more negative attitudes toward medications, fewer reasons for adherence, and more perceived reasons for nonadherence compared with adherent individuals. The strongest attitudinal predictors for nonadherence were difficulties with medication routines (odds ratio = 2.2) and negative attitudes toward drugs in general (odds ratio = 2.3). LIMITATIONS Results interpretation is limited by cross-sectional design, self-report methodology, and sample size. CONCLUSIONS Comorbid substance abuse, negative attitudes toward mood-stabilizing medication, and difficulty managing to take medication in the context of one's daily schedule are primary determinants of medication treatment adherence. A patient-centered collaborative model of care that addresses negative attitudes toward medication and difficulty coping with medication routines may be ideally suited to address individual adherence challenges.
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Affiliation(s)
- Martha Sajatovic
- Case Western Reserve University School of Medicine, Cleveland, OH, USA.
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A framework for planning and critiquing medication compliance and persistence research using prospective study designs. Clin Ther 2009; 31:421-35. [DOI: 10.1016/j.clinthera.2009.02.021] [Citation(s) in RCA: 32] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/22/2008] [Indexed: 11/22/2022]
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Depp CA, Moore DJ, Patterson TL, Lebowitz BD, Jeste DV. Psychosocial interventions and medication adherence in bipolar disorder. DIALOGUES IN CLINICAL NEUROSCIENCE 2008. [PMID: 18689293 PMCID: PMC3181867 DOI: 10.31887/dcns.2008.10.2/cadepp] [Citation(s) in RCA: 31] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Recent research has indicated that psychosocial interventions can have a valuable role in reducing the substantial psychosocial disability associated with bipolar disorder. Randomized controlled trials of these interventions indicate that improvements are seen in symptoms, psychosocial functioning, and treatment adherence. These interventions, systematically presented in the form of standardized treatment manuals, vary in format, duration, and theoretical basis. All are meant to augment pharmacotherapy, which represents the standard of treatment in the field. Modalities that have gathered the most empirical support include cognitive-behavioral therapy, family-focused therapy, interpersonal and social rhythms therapy, and psychoeducation. The enhancement of adherence to pharmacotherapy is a common therapeutic target, due to the association of nonadherence with higher relapse rates, hospitalization, and health care costs among people with bipolar disorder. Given the complexity of nonadherence behavior, multicomponent interventions are often required. In this review, we provide an overview of the rationale, evidence base, and major psychotherapeutic approaches in bipolar disorder, focusing on the assessment and enhancement of medication adherence.
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Affiliation(s)
- Colin A Depp
- Sam and Rose Stein Institute for Research on Aging, Department of Psychiatry, University of California, San Gilman Drive, 0664 La Jolla, CA 92093-0664, USA.
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Gaudiano BA, Weinstock LM, Miller IW. Improving treatment adherence in bipolar disorder: a review of current psychosocial treatment efficacy and recommendations for future treatment development. Behav Modif 2008; 32:267-301. [PMID: 18391049 PMCID: PMC3691269 DOI: 10.1177/0145445507309023] [Citation(s) in RCA: 53] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
Treatment adherence is a frequent problem in bipolar disorder, with research showing that more than 60% of bipolar patients are at least partially nonadherent to medications. Treatment nonadherence is consistently predictive of a number of negative outcomes in bipolar samples, and the discontinuation of mood stabilizers places these patients at high risk for relapse. Several types of adjunctive treatment (family, psychoeducational, cognitive-behavioral) have been investigated for improving symptoms and functioning in bipolar patients with some success. To date, less attention has been paid to developing treatments specifically to promote treatment adherence to and engagement with pharmacological as well as behavioral treatments in patients with bipolar disorder. First, we review the effects of adjunctive interventions specifically on treatment adherence outcomes in 14 published clinical trials. Based on this empirical knowledge base, we present a preliminary description of the treatment strategies that appear most promising for improving adherence. The article also provides research recommendations for developing more effective interventions for the purpose of improving bipolar treatment adherence. Finally, special treatment considerations, including the potential impact of comorbid substance abuse and bipolar depression, are discussed.
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Affiliation(s)
- Brandon A Gaudiano
- Department of Psychiatry and Human Behavior, Brown Medical School Psychosocial Research Program, Butler Hospital, Providence, Rhode Island 02906, USA.
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Abstract
Despite the success of pharmacotherapy in the management of bipolar disorder, as many as one-half of those in treatment discontinue their medication over time. Currently, no self-report measure is available that predicts treatment engagement in bipolar disorder. The goal of the current study was to develop a measure of awareness of symptoms and attitudes toward treatment among those with bipolar disorder. Sixty-six participants diagnosed with bipolar I disorder on the SCID completed the Treatment Attitudes Questionnaire (TAQ) and were then followed for up to 2 years to assess symptom levels. Medication data were available for 37 participants. Analyses of the TAQ were conducted to examine reliability, predictors of subscales, and how well scores predicted medication and symptom levels over time. Results indicate that previous episodes of depression, but not episodes of mania, correlated with increased scores on the Insight and the Enjoyment of Mania subscales. Scores on the Nonbiological Attributions subscale predicted lower levels of lithium as well as increased depressive symptoms over time. Although the current study includes limited measurement of treatment engagement and a small sample size, this easily administered scale may help treatment planning for those with bipolar disorder.
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Depp CA, Cain AE, Palmer BW, Moore DJ, Eyler LT, Lebowitz BD, Patterson TL, Jeste DV. Assessment of medication management ability in middle-aged and older adults with bipolar disorder. J Clin Psychopharmacol 2008; 28:225-9. [PMID: 18344736 PMCID: PMC3593666 DOI: 10.1097/jcp.0b013e318166dfed] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
Medication nonadherence is a key clinical concern in bipolar disorder (BD) across the life span. Cognitive deficits in older adults with BD may hinder medication management ability, which, in turn, may lead to nonadherence. Using an innovative performance-based measure of medication management ability, the Medication Management Ability Assessment (MMAA), we compared performance of 29 middle-aged older community-dwelling outpatients with BD who were clinically stable (mean age, 61 years; SD, 11 years; range, 45-86 years) with those of 59 normal control subjects (NCs) and 219 outpatients with schizophrenia. The MMAA is a role-play task that simulates a medication regimen likely to be encountered by older adults. Within the BD group, we examined the relationships of MMAA scores to demographic, psychiatric symptoms severity, and the Mattis Dementia Rating Scale (DRS) scores. The BD group made 2.8 times the errors on the MMAA than NCs (BD group, 6.2; SD, 5.5 vs NCs, 2.2; SD, 2.5) and did not significantly differ from the Schizophrenia group in errors on the MMAA. Errors in the BD group were more likely to be taking in too few medications as taking in too many. Within the BD group, a significant correlation was seen between MMAA scores and the DRS Total score, but not with age, education, Brief Psychiatric Rating Scale, Hamilton Depression Rating Scale, number of psychiatric medications, or medical conditions. Among DRS subscales, the Memory Subscale correlated most strongly with MMAA errors. This small cross-sectional study suggests that deficits in medication management ability may be present in later-life BD. Neurocognitive deficits may be important in understanding problems with unintentional nonadherence.
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Affiliation(s)
- Colin A Depp
- Department of Psychiatry, University of California, San Diego, CA, USA.
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Abstract
BACKGROUND Adherence to treatment is a major determinant of outcome in bipolar disorder. Poor insight, attitudes towards treatment, and poor understanding of medications and the illness can all lead to reduced adherence. Nonadherence and partial adherence both also appear to play a significant role in relapse. Thirty to forty percent of patients with bipolar disorder who attempt to be adherent to treatment are actually only partially adherent. Clinicians frequently address the problem of poor adherence by adding an antipsychotic medication to the mood stabilizer regimen. The availability of a long-acting atypical antipsychotic raises the possibility of using this agent to prevent bipolar relapse. METHODS The literature on the use of depot antipsychotics in bipolar illness is reviewed, based on a search of PubMed and Ovid Medline. RESULTS No randomized, controlled trials of depot antipsychotics in bipolar illness have been performed. However, several case series and naturalistic trials that have used first generation agents suggest that depot antipsychotics are effective in reducing relapse in bipolar illness. CONCLUSIONS Depot antipsychotics, including long-acting first and second generation agents, can be important adjuncts in the long-term management of bipolar illness. Controlled trials with these agents in bipolar disorder are warranted.
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Affiliation(s)
- Rif S El-Mallakh
- Department of Psychiatry and Behavioral Sciences, University of Louisville School of Medicine, Louisville, KY 40202, USA.
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Colom F, Vieta E. Sudden glory revisited: cognitive contents of hypomania. PSYCHOTHERAPY AND PSYCHOSOMATICS 2007; 76:278-288. [PMID: 17700048 DOI: 10.1159/000104704] [Citation(s) in RCA: 13] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/01/2023]
Abstract
INTRODUCTION Cognitive aspects of hypomania have been historically neglected. Although they do not have an etiological role, they may be essential to understand factors underlying the hypomanic ascent in bipolar disorders and constitute key modulators of the course of illness. METHODS We have performed a critical review of the existing literature on the role of cognition during hypomania, considering outputs coming from very different fields of knowledge. RESULTS There is a nuclear cognitive change occurring in most hypomanic phases that we have defined as 'anastrophic' thinking. This key cognitive procedure has several implications--going from social sciences and philosophy to basic sciences. CONCLUSIONS Hypomania has received certain attention from cognitive theorists. Unfortunately, this attention has not been translated into a cognitive model that is as robust as the one seen in depression. The inclusion of certain psychological aspects in models of hypomania should give rise, as occurred with depression, to an increased emphasis on psychoeducation and cognitive modification of behavioral patterns in the management of this disorder with combined psychological and pharmacological tools.
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Affiliation(s)
- Francesc Colom
- Bipolar Disorders Program, Institute of Neuroscience, Hospital Clinic, University of Barcelona, IDIBAPS, Barcelona, Spain
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Veazie PJ, Cai S. A connection between medication adherence, patient sense of uniqueness, and the personalization of information. Med Hypotheses 2007; 68:335-42. [PMID: 17008025 DOI: 10.1016/j.mehy.2006.04.077] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/01/2006] [Accepted: 04/05/2006] [Indexed: 11/25/2022]
Abstract
Adherence to treatment regimens is important to achieve optimal disease management. However, nonadherence is evident across numerous clinical contexts, which leads to a higher disease burden on society. Among the various factors associated with patient adherence behavior, patient beliefs are the most influential set of factors. Several cognitive-social models and constructs that incorporate patient belief have been developed to explain patient health behaviors, such as the Health Belief Model, Self-Efficacy Model, Theory of Planned Behavior and so on. However, these models do not explain the formulation of health beliefs. The underlying mechanism accounting for patient variation in information processing that generates beliefs needs to be investigated, which will inform the development of interventions. We propose that patient's sense of uniqueness moderates the self-attribution of statistically-based information. Self-attribution is defined as a person's perceived probability that a statement applies to herself, and is influenced by experience and sense of uniqueness. Sense of uniqueness is a person's general belief regarding how unique she is. Statistically-based information is defined as information derived from or regarding aggregated effects or influences. Basically, the proposed hypothesis is that patients who have a stronger belief that they are unique are less likely to attribute to themselves statistically-based propositions regarding the majority of their group and are more likely to attribute to themselves statistically-based propositions regarding the minority. We further model the relationship between sense of uniqueness and self-attribution of information in terms of an idealized inexperienced person, and then extend the model to include the effect of personal experience. The estimation of hypothesis-specific effect parameters can be achieved by maximum likelihood. In conclusion, the sense of uniqueness hypothesis is general to the formulation of personal beliefs and consequently has implications for deliberate health behavior and indeed personal behavior in general.
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Affiliation(s)
- Peter J Veazie
- Department of Community and Preventive Medicine, University of Rochester, School of Medicine and Dentistry, 601 Elmwood Avenue, PO Box 644, Rochester, NY 14642, USA.
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Abstract
Estimates of adherence to long-term medication regimens range from 17% to 80%, and nonadherence (or nonpersistence) can lead to increased morbidity, mortality, and healthcare costs. Multifaceted interventions that target specific barriers to adherence are most effective, because they address the problems and reinforce positive behaviors. Providers must assess their patients' understanding of the illness and its treatment, communicate the benefits of the treatment, assess their patients' readiness to carry out the treatment plan, and discuss any barriers or obstacles to adherence that patients may have. A positive, supporting, and trusting relationship between patient and provider improves adherence. Individual patient factors also affect adherence. For example, conditions that impair cognition have a negative impact on adherence. Other factors--such as the lack of a support network, limited English proficiency, inability to obtain and pay for medications, or severe adverse effects or the fear of such effects--are all barriers to adherence. There are multiple reasons for nonadherence or nonpersistence; the solution needs to be tailored to the individual patient's needs. To have an impact on adherence, healthcare providers must understand the barriers to adherence and the methods or tools needed to overcome them. This report describes the barriers to medication adherence and persistence and interventions that have been used to address them; it also identifies interventions and compliance aids that practitioners and organizations can implement.
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