Beliefs About Medicines Predict Side-Effects of Placebo Modafinil.

BACKGROUND: Patients receiving placebo in clinical trials often report side-effects (nocebo effects), but contributing factors are still poorly understood. PURPOSE: Using a sham trial of the cognition-enhancing "smart pill" Modafinil we tested whether medication beliefs and other psychological factors predicted detection and attribution of symptoms as side-effects to placebo. METHODS: Healthy students (n = 201) completed measures assessing beliefs about medication, perceived sensitivity to medicines, negative affectivity, somatization, and body awareness; 66 were then randomized to receive Deceptive Placebo (told Modafinil-given placebo, 67 to Open Placebo (told placebo-given placebo, and 68 to No Placebo. Memory and attention tasks assessed cognitive enhancement. Nocebo effects were assessed by symptom checklist. RESULTS: More symptoms were reported in the Deceptive Placebo condition (M = 2.65; SD = 2.27) than Open Placebo (M = 1.92; SD = 2.24; Mann-Whitney U = 1,654, z = 2.30, p = .022) or No Placebo (M = 1.68; SD = 1.75, Mann-Whitney U = 1,640, z = 2.74, p = .006). Participants were more likely to attribute symptoms to Modafinil side-effects if they believed pharmaceuticals to be generally harmful (incidence rate ratio [IRR] = 1.70, p = .019), had higher perceived sensitivity to medicines (IRR = 1.68, p = .011), stronger concerns about Modafinil (IRR = 2.10, p < .001), and higher negative affectivity (IRR = 2.37, p < .001). CONCLUSIONS: Beliefs about medication are potentially modifiable predictors of the nocebo effect. These findings provide insight into side-effect reports to placebo and, potentially, active treatment.

Validation of the Swedish version of the Beliefs about Medicines Questionnaire, based on people with epilepsy.

TITLE: Validation of the Swedish version of the Beliefs about Medicines Questionnaire, based on people with epilepsy. PURPOSE: The aims of the study were to explore the latent structure of the Swedish Beliefs about Medicines Questionnaire (BMQ), to investigate its reliability and to identify the extent to which individual factors among people with epilepsy (PWE), as well as their general beliefs about medication, predict their beliefs about their specific anti-seizure drugs (ASDs). METHODS: One-hundred and fifty six included study participants diagnosed with epilepsy and with a well-established neurological follow-up completed an array of rating scales. Included were the Swedish BMQ, which captures beliefs about medicines, scales for symptoms of anxiety and depression and sense of self-efficacy, as well as a general questionnaire regarding their social situation in general. Statistical analysis included Principal Component Analyses (PCA) and hierarchical multiple regression analysis. RESULTS: The PCA revealed a two-factor structure for each of the BMQ-subscales with acceptable (BMQ-G) to high (BMQ-S) internal consistency. The only individual factor that predicted variance in beliefs about medication was patient gender, where levels of both anxiety and depression were elevated in women. CONCLUSION: The Swedish BMQ exhibits psychometric features indicating its reliable use in adult PWE. Our results suggest that the BMQ provides information about the patients' view of their medication regardless of their general mood and that women hold stronger beliefs of concern beyond influence from their levels of depression and anxiety.

The association between patients' perceived continuity of care and beliefs about oral anticancer treatment.

PURPOSE: To explore factors associated with necessity beliefs and concerns among patients receiving oral anticancer therapy (OACT) and, specifically, to examine the relationship between continuity of care (COC) and patients' beliefs about OACT. METHODS: A cross-sectional study was conducted among patients from four oncology centers receiving OACT (either targeted, hormonal, or chemotherapy). Two months after OACT initiation, patients were asked to participate in a face-to-face or telephone survey. The Beliefs about Medicines Questionnaire was used to examine patients' perceptions of their personal necessity for OACT and concerns about potential adverse effects. The Nijmegen Continuity Questionnaire was used to assess patients' perceived COC. Data on clinical characteristics were collected from medical records. RESULTS: Participants' beliefs about OACT necessity (n = 91) were found to be associated with COC within the oncology team, and with COC between the oncology specialist and the primary care physicians (ß = 0.27, p = 0.003; ß = 0.22, p = 0.02, respectively), beyond age, depression, and cancer type (ΔR2 = 0.14, p < 0.001). Additionally, the difference between participants' beliefs about OACT necessity and their OACT-related concerns was associated with COC within the oncology team (ß = 0.30, p = 0.001), beyond age, income, family status, and cancer type (ΔR2 = 0.09, p = 0.001). CONCLUSIONS: This study shows that cancer patients' perceptions about the COC between care providers are related to their beliefs about OACT necessity, thus providing evidence for the importance of health care delivery approaches that support COC within the oncology team and between the oncology specialist and the primary care physician.

The challenges of assessing patients' medication beliefs: a qualitative study.

BACKGROUND: An estimated 50% of patients do not take their medication as prescribed, with medication adherence associated with adverse outcomes and higher costs of care. The Necessity-Concerns Framework identified individual's beliefs about their medication as playing a key role in adherence, and UK Clinical Adherence Guidelines recommend eliciting and incorporating individual's perceptions of their medication within the consultation. The Beliefs about Medicines Questionnaire (BMQ) is widely used to assess medication beliefs, however, given the condition-specific nature of some self-management regimens, it is unknown whether this tool is able to fully capture beliefs about more complex medication regimens. METHODS: We examined the challenges of assessing medication beliefs using the BMQ in 20 people with a complex relapsing-remitting condition recruited from community sources. Data were collected from people with psoriasis; a patient group characterised by complex medication regimens, which include therapies that are applied topically, phototherapy/photochemotherapy, and therapies that are administered orally or via subcutaneous or intravenous injections. Semi-structured cognitive interviews were undertaken, with responses coded using established schedules and analysed using Content analysis. RESULTS: Individual's beliefs about their condition specific therapies were not accurately captured by the BMQ. Medication beliefs as expressed during 'real-time' completion of the BMQ were underestimated, or failed to be captured, by the corresponding scores given by participants. There was mismatch between the terminology used in the scale and individuals perceptions of their condition and the complexity of its management and treatment outcomes. Currently the BMQ cannot represent beliefs about medicines underuse, even though some individuals with psoriasis viewed access to therapies as overly restrictive. Some the BMQ items were misinterpreted in part due to ambiguous item wording or due to misreading by participants. CONCLUSIONS: This is the first study to identify general and condition-specific difficulties experienced by individuals completing the BMQ in 'real time'. The main implication of this research is the need to develop condition-specific versions of the BMQ in order that this important instrument can capture the full range of medication beliefs in individuals living with a complex relapsing-remitting condition. Access to condition-specific versions could significantly increase our understanding of beliefs which facilitate or reduce medication adherence.

Patients' perspectives on antiepileptic medication: relationships between beliefs about medicines and adherence among patients with epilepsy in UK primary care.

BACKGROUND: Nonadherence to antiepileptic drugs (AEDs) can result in suboptimal outcomes for patients. AIM: This study aimed to assess the utility of a theory-based approach to understanding patient perspectives on AEDs and adherence. METHOD: Patients with epilepsy, identified by a GP case note review, were mailed validated questionnaires assessing their perceptions of AEDs and their adherence to them. RESULTS: Most (84.9%) of the 398 AED-treated respondents accepted the necessity of AEDs, but over half expressed doubts, with 55% disagreeing or uncertain about the statement 'I would prefer to take epilepsy medication than risk a seizure'. Over a third (36.4%) expressed strong concerns about the potential negative effects of AEDs. We used self-report and medication possession ratio to classify 36.4% of patients as nonadherent. Nonadherence was related to beliefs about medicines and implicit attitudes toward AEDs (p<0.05). Adherence-related attitudes toward AEDs were correlated with general beliefs about pharmaceuticals (BMQ General: General Harm, General Overuse, and General Benefit scales) and perceptions of personal sensitivity to medicines (PSM scale). CONCLUSION: We identified salient, adherence-related beliefs about AEDs. Patient-centered interventions to support medicine optimization for people with epilepsy should take account of these beliefs.

Strengthening the Link between Vaccine Predispositions and Vaccine Advocacy through Certainty.

BACKGROUND: Instruments designed to assess individual differences in predispositions towards vaccination are useful in predicting vaccination-related outcomes. Despite their importance, there is relatively little evidence regarding the conditions under which these instruments are more predictive. The current research was designed to improve the ability of these kinds of instruments to predict vaccination advocacy by considering the certainty associated with the responses to vaccination scales. METHOD: Across two studies, participants completed the Beliefs about Medicines Questionnaire BMQ scale (Study 1) or the Vaccination Attitudes Examination (VAX) scale (Study 2). The certainty participants had in their responses to each scale was either measured (Study 1) or manipulated (Study 2). Intentions to advocate in favor of vaccination served as the criterion measure in both studies. RESULTS: As expected, the scales significantly predicted vaccination advocacy, contributing to enhancing the predictive validity of the instruments used in the studies. Most relevant, certainty moderated the extent to which these scales predicted vaccination advocacy, with greater consistency between the initial scores and the subsequent advocacy willingness obtained for those with higher certainty. CONCLUSIONS: Certainty can be useful to predict when the relationship between vaccination-related cognitions (i.e., beliefs or attitudes) and advocacy willingness is likely to be stronger.

Differences in Beliefs About Cholesterol-Lowering Medications Among the Visegrad Group Countries: A Cross-Sectional Study.

Background: New cholesterol guidelines highlight more personalized risk assessments and new cholesterol-lowering drugs for people at the highest risk for cardiovascular disease. Adherence due to fear of and lack of trust in medications prevents treatment to provide better health outcomes. Objectives: The aim of our study was to investigate the possible differences in the beliefs about the necessity and concerns regarding lipid-lowering drugs among the Visegrad Group countries. Methods: The Beliefs About Medicines Questionnaire (BMQ-Specific) was used in our research. The responses of 205 Hungarian, 200 Slovak, 235 Czech, and 200 Polish participants, all taking cholesterol-lowering medications, were compared to each other. Results: Hungarian participants' belief in the necessity of cholesterol-lowering drugs was significantly lower compared to the Slovak (P = 0.001), Czech (P = 0.037), and Polish (P < 0.001) participants. While no difference was observed between the Czech and Slovak responses (P = 0.154), both the Czech (P < 0.001) and Slovak (P = 0.006) respondents' belief regarding necessity was lower than that of the Polish. Regarding concerns, the only significant difference was observed between the Czech and the Polish respondents (P = 0.011). Conclusions: While the beliefs about benefits (necessity) are most prominent among the Polish participants, except in comparison to Czech responses, the Visegrad Group countries do not differ considerably regarding their beliefs about the fear (concerns) of the treatment.

Cultural Adaptation and Linguistic Validation of the Beliefs about Medicines Questionnaire in Malaysia.

BACKGROUND: Low rate of adherence was found strongly associated with patients' beliefs across the studies about chronic diseases with hypertension. A crucial move is needed to bridge the gap between appropriate assessment tools and local hypertensive patients' medication adherence. OBJECTIVE: To produce a translated version in Malay language of Beliefs about Medicines Questionnaire (BMQ) that was "conceptually equivalent" to the original English version for use in local clinical practice and research. METHODS: The forward translation process was conducted by two independent professional translators and back translation was done by two other independent translators. A reliability analysis was conducted on 238 conveniently selected hypertensive patients. Intraclass correlation coefficient (ICC) was used to assess test-retest reliability for the randomly selected 40 patients in a period of 2 weeks. Discriminant validity was tested through Necessity-Concerns differential, BMQ subscales, and other parameters. RESULTS: The overall Cronbach alpha for the internal consistency was good (0.860). The subscales of the BMQ demonstrated adequate internal consistency, with Cronbach alpha value of 0.759 for Specific-Necessity, 0.762 for Specific Concern, 0.624 for General-Overuse, and 0.756 for General-Harm. The ICC was excellent (0.922). Discriminant validity revealed that BMQ Specific-Necessity score was significantly inversely correlated with the systolic blood pressure level. Systolic and diastolic blood pressure levels (P = 0.038; P = 0.05) were reported to be significantly correlated with the Necessity-Concerns differential, with Necessity score equal or exceeding Concerns score. CONCLUSIONS: The Malay-translated version of BMQ is a reliable and valid tool to assess patient belief about medication, especially medication adherence among the hypertensive patients in Malaysia.

Psychometric properties of the Beliefs about Medicine Questionnaire-adjuvant endocrine therapy (BMQ-AET) for women taking AETs following early-stage breast cancer.

This study evaluated the Beliefs about Medicine Questionnaire to explore adherence to adjuvant endocrine therapy after treatment for breast cancer (BMQ-AET). Factor structure of the BMQ-AET was explored alongside internal consistency, convergent validity and acceptability. The BMQ-AET Specific Scale fitted the original 10 item model. Internal consistency of the BMQ-AET was much improved compared to the original BMQ and convergent validity showed predicted direction of correlation, although correlation with BMQ-AET concerns scale was low. Acceptability was good. The evaluation of the BMQ-AET is encouraging, and could facilitate future research around adherence to AET.

The necessity-concerns framework predicts adherence to medication in multiple illness conditions: A meta-analysis.

OBJECTIVE: This meta-analysis investigated whether beliefs in the necessity and concerns of medicine and the necessity-concerns differential are correlated with medication adherence on a population level and in different conditions. METHODS: An electronic search of Web of Science, EMBASE, PubMed and CINAHL was conducted for manuscripts utilising the Beliefs about Medicines Questionnaire and comparing it to any measure of medication adherence. Studies were pooled using the random-effects model to produce a mean overall effect size correlation. Studies were stratified for condition, adherence measure, power and study design. RESULTS: Ninety-four papers were included in the meta-analysis. The overall effect size(r) for necessity, concerns, and necessity-concerns differential was 0.17, -0.18 and 0.24 respectively and these were all significant (p<0.0001). Effect size for necessity was stronger in asthma and weaker in the cardiovascular group compared to the overall effect size. CONCLUSION: Necessity and concerns beliefs and the necessity-concerns differential were correlated with medication adherence on a population level and across the majority of included conditions. The effect sizes were mostly small with a magnitude comparable to other predictors of adherence. PRACTICE IMPLICATIONS: This meta-analysis suggests that necessity and concern beliefs about medicines are one important factor to consider when understanding reasons for non-adherence.

Predictors of adherence to treatment in bronchiectasis.

OBJECTIVES: We aimed to determine if beliefs about treatment, clinical factors and quality of life predicted adherence to treatment in patients with bronchiectasis. METHODS: We recruited participants with confirmed bronchiectasis to a one-year study. We calculated adherence to treatment using medication possession ratios and self-report. Baseline Beliefs about Medicines, clinical, demographic and Quality of Life Questionnaire-Bronchiectasis data were collected. We used logistic regression to determine predictors of adherence to treatment during the subsequent year. RESULTS: Seventy-five participants were recruited. Beliefs about harm, age and total number of prescribed medications were predictors of adherence to inhaled antibiotics. Concerns about medication, age and Quality of Life Questionnaire-Bronchiectasis Treatment Burden were predictors of adherence to other respiratory medicines. Beliefs about necessity of airway clearance and age were predictors of adherence to airway clearance. CONCLUSION: Beliefs about treatment, age, number of prescribed medications and perceived treatment burden predicted subsequent adherence in bronchiectasis, thereby, providing potential targets for future interventions in this population. Clinicians can use these data to identify patients with bronchiectasis who might be at risk of non-adherence i.e. those who are younger, have concerns about medications, who do not think airway clearance is necessary or who are prescribed numerous medications.

Chronically Ill Czech Patients' Beliefs About Medicines: The Psychometric Properties and Factor Structure of the BMQ-CZ.

The main objective of this study was to assess the factor structure and psychometric properties of the Czech translation of the Beliefs about Medicines Questionnaire (BMQ-CZ). It was hypothesized that the 4-factor structure of the BMQ-CZ would be confirmed and that psychometric properties would be verified by using positive or negative correlations with self-reported adherence, illness perceptions, and medication statements. A total of 627 people were approached, and 467 agreed to participate. The sample included chronically ill patients as well as patients seeking allopathic and homeopathic care. As a measure of criterion-related validity, the BMQ-CZ was administered along with the translated Czech versions of the Medication Adherence Report Scale (MARS-CZ) and the Brief Illness Perception Questionnaire (Brief IPQ-CZ) and additional assertions. The factor structure, reliability, and validity of the BMQ-CZ were evaluated. The internal consistency of the BMQ-CZ was satisfactory (Cronbach α = .69-.85). A factor analysis supported the BMQ-CZ's 4-factor structure, and the concurrrent validity of the BMQ-CZ was supported by positive correlations with self-reported measures of adherence and beliefs about medicines and disease. The BMQ-CZ demonstrated sufficient psychometric performance as a self-reported measure of medication beliefs among patients with hypertension, diabetes, and rheumatic disease.