Acceptability of 'as needed' biologic therapy in psoriasis: insights from a multi-stakeholder mixed methods study.

OBJECTIVES: Biologic therapies have led to increasing numbers of patients with psoriasis who have clear or nearly clear skin. Current practice is that biologic therapy is continued indefinitely in these patients, contributing to a substantial long-term drug and healthcare burden. 'As needed' biologic therapy in psoriasis may address this, however our understanding of patient and clinician perceptions of this strategy is limited. METHODS: We first conducted UK-wide online scoping surveys of patients with psoriasis and dermatology clinicians to explore their views on 'as needed' biologic therapy. Using topic guides informed by these survey findings, we then carried out qualitative focus groups with patients and clinicians. Themes were identified using reflexive thematic analysis. RESULTS: Of 67 patients and 27 clinicians completing the scoping surveys, 67% (43/64) and 78% (21/27), respectively, supported the use of 'as needed' biologic therapy. Respondents highlighted advantages such as a reduction in healthcare burden and greater ownership of care. Challenges included logistics of 'as needed' drug provision and potential risks of disease flare and drug immunogenicity. Focus groups comprised 15 patients with psoriasis (9 female [60%], average disease duration 32 years [range 9-64 years]) and 9 dermatology clinicians (8 female [89%], average dermatology experience 20 years [range 8-33 years]). Both patients and clinicians felt that an 'as needed' treatment approach will deliver a reduction in treatment burden and present an opportunity for patient-led ownership of care. Both groups highlighted the importance of ensuring ongoing access to medication and discussing the potential impact of psoriasis recurrence. Patient preferences were influenced by their lived experiences, particularly previous difficulties with medication delivery logistics and establishing disease control. Clinician perspectives were informed by personal experience of their patients adapting their own dosing schedules. Clinicians highlighted the importance of targeted patient selection for an 'as needed' approach, ongoing disease monitoring, and prompt re-access to medications upon psoriasis recurrence. CONCLUSION: These data indicate that 'as needed' biologic therapy in psoriasis is acceptable for both patients and clinicians. Formal assessment of clinical effectiveness and cost effectiveness is warranted, to enable the real-world potential of this approach to be realised.

Changing medication-related beliefs: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: Medication-related beliefs, for example, beliefs that medicines are unnecessary or that side effects are likely, can influence medication behaviors and experiences, potentially impacting quality of life and mortality. At times, it may be useful to change medication-related beliefs, for example, to reduce patients' concerns about side effects when extensive evidence suggests side effects are rare. Currently we do not know the most effective methods to address medication beliefs. METHOD: Systematic review and meta-analysis of randomized controlled trials that measured medication-related beliefs in people prescribed medication for long-term condition(s). We extracted data on behavior change techniques (BCTs), belief measure, study and patient characteristics, risk of bias, and quality of description. RESULTS: We identified 56 trials randomizing 8,714 participants. In meta-analysis, interventions led to small-to-medium effects (n = 36, Hedges' g = .362, 95% confidence interval [CI] [.20, .52], p < .001) in increasing beliefs about medication need/benefit and reducing concerns about medication (n = 21, Hedges' g = -.435, 95% CI [-0.72, -0.15], p < .01). Effect sizes were higher for interventions that reported a significant effect on adherence. Problem solving, information about health consequences, and social support (unspecified) were the most prevalent BCTs. Fourteen BCTs were associated with significant effects on need/benefit beliefs and four BCTs were associated with significant effects on concern beliefs. CONCLUSION: It is possible to modify medication-related beliefs using a range of interventions and techniques. Future research should explore the best ways to operationalize these BCTs for specific health conditions to support medication beliefs and improve adherence. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

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.

Utilization of the beliefs about medicine questionnaire and prediction of medication adherence in China: A systematic review and meta-analysis.

BACKGROUND: Beliefs about medicines have been proposed as a strong determinant of medication adherence. It has been widely assessed using a Belief about Medicines Questionnaire (BMQ) for 20 years outside of China. OBJECTIVES: To investigate the use of the BMQ in China, and to evaluate the association between beliefs about medicines and medication adherence in the Chinese population. METHODS: A systematic review of studies published before February 2019 was performed in PubMed, EMBASE, PsycINFO, CNKI and WANFANG DATA. Any quantitative study that measured Chinese adults' medicine beliefs using BMQ translations was included. Random-effects meta-analysis with 95% confidence interval (CI) was used to test the correlations between BMQ-Specific components (Necessity Belief or Concerns or their differential scores) and medication adherence. RESULTS: Fifty-eight eligible articles (n = 12,595) were identified with sample sizes ranged from 48 to 967. Three meta-analyses (n = 17, 18 & 19) containing total 22 studies were performed. Adherence was significantly correlated with necessity beliefs (pooled correlation coefficient = 0.32, 95% CI: 0.21, 0.43), concerns (-0.35, 95% CI: -0.42, -0.28), and the necessity-concerns differential score (0.25, 95% CI: 0.15, 0.36). There was significant heterogeneity between studies for necessity beliefs (I2 = 93%, p < .001), concerns (I2 = 83%, p < .001) and differential score (I2 = 95%, p < .001). CONCLUSION: The BMQ appears to be a reliable tool for assessing medication beliefs in the Chinese population. Chinese people's specific medicine beliefs about medicines were significantly correlated with medication adherence. The Necessity-Concerns Framework was suggested as a useful conceptual model to explain Chinese patients' medication adherence.

Depression and state anxiety scores during assisted reproductive treatment are associated with outcome: a meta-analysis.

This meta-analysis investigated whether state anxiety and depression scores during assisted reproductive technology (ART) treatment and changes in state anxiety and depression scores between baseline and during ART treatment are associated with treatment outcome. PubMed, PsycInfo, Embase, ScienceDirect, Web of Science and Scopus were searched and meta-analytic data analysed using random effects models to estimate standardized mean differences. Eleven studies (2202 patients) were included. Women who achieved pregnancy had significantly lower depression scores during treatment than women who did not become pregnant (-0.302; 95% CI: -0.551 to -0.054, z = -2.387, P = 0.017; I2 = 77.142%, P = 0.001). State anxiety scores were also lower in women who became pregnant (-0.335; 95% CI: -0.582 to -0.087, z = -2.649, P = 0.008; I2 = 81.339%, P = 0.001). However, changes in state anxiety (d = -0.056; 95% CI: -0.195 to 0.082, z = -0.794; I2 = 0.00%) and depression scores (d = -0.106; 95% CI: -0.296 to 0.085, z = -1.088; I2 = 0.00%) from baseline to treatment were not associated with ART outcome. Clinics should aim to promote better psychosocial care to help patients manage the psychological and physical demands of ART treatment, giving realistic expectations.

Beliefs About Pharmaceutical Medicines and Natural Remedies Explain Individual Variation in Placebo Analgesia.

This study examined whether placebo responses were predicted by a theoretical model of specific and general treatment beliefs. Using a randomized crossover, experimental design (168 healthy individuals) we assessed whether responses to a cold pressor task were influenced by 2 placebo creams described as pharmaceutical versus natural. We assessed whether placebo responses were predicted by pretreatment beliefs about the treatments (placebo) and by beliefs about the pain. The efficacy of pharmaceutical as well as natural placebos in reducing pain intensity was predicted by aspects of pain catastrophizing including feelings of helplessness (pharmaceutical: B = .03, P < .01, natural: B = .02, P < .05) and magnification of pain (pharmaceutical: B = .04, P < .05, natural: B = .05, P < .05) but also by pretreatment necessity beliefs (pharmaceutical: B = .21, P < .01, natural: B = .16, P < .05) and, for the pharmaceutical condition, by more general beliefs about personal sensitivity to pharmaceuticals (B = .14, P < .05). Treatment necessity beliefs also partially mediated the effects of helplessness on placebo responses. Treatment necessity beliefs for the pharmaceutical placebo were influenced by general pharmaceutical beliefs whereas necessity beliefs for the natural placebo were informed by general background beliefs about holistic treatments. Our findings show that treatment beliefs influence the placebo effect suggesting that they may offer an additional approach for understanding the placebo effect. PERSPECTIVE: Placebo effects contribute to responses to active analgesics. Understanding how beliefs about different types of treatment influence placebo analgesia may be useful in understanding variations in treatment response. Using the cold pressor paradigm we found that placebo analgesia was influenced by beliefs about natural remedies, pharmaceutical medicines, and about pain.

No blank slates: Pre-existing schemas about pharmaceuticals predict memory for side effects.

OBJECTIVES: Attribution of symptoms as medication side effects is informed by pre-existing beliefs about medicines and perceptions of personal sensitivity to their effects (pharmaceutical schemas). We tested whether (1) pharmaceutical schemas were associated with memory (recall/recognition) for side effect information (2) memory explained the attribution of a common unrelated symptom as a side effect. DESIGN: In this analogue study participants saw the patient leaflet of a fictitious asthma drug listing eight side effects. MAIN OUTCOME MEASURES: We measured recall and recognition memory for side effects and used a vignette to test whether participants attributed an unlisted common symptom (headache) as a side effect. RESULTS: Participants who perceived pharmaceuticals as more harmful in general recalled fewer side effects correctly (rCorrect Recall = -.273), were less able to differentiate between listed and unlisted side effects (rRecognition Sensitivity = -.256) and were more likely to attribute the unlisted headache symptom as a side effect (rside effect attribution = .381, ps < .01). The effect of harm beliefs on side effect attribution was partially mediated by correct recall of side effects. CONCLUSION: Pharmaceutical schemas are associated with memory for side effect information. Memory may explain part of the association between pharmaceutical schemas and the attribution of unrelated symptoms as side effects.

Beliefs about medication predict the misattribution of a common symptom as a medication side effect--Evidence from an analogue online study.

OBJECTIVE: Some perceived medication side effects may be 'normal' symptoms that patients misattribute to the medication. Using an analogue approach, we tested if medication beliefs predict whether participants misattribute a headache as a side effect and subsequently intend to stop medication. METHODS: We recruited 690 participants, 223 reporting a past asthma diagnosis. They received information about asthma and Molair, a fictitious asthma treatment modeled on a licensed treatment (montelukast). We varied the description of efficacy and side effects (which did not include headache). Pre-exposure to this information, participants completed the Beliefs about Medicine Questionnaire (BMQ)-General and the Perceived Sensitivity to Medicines Scale (PSM), post-exposure they completed the BMQ-Specific. Participants were asked to imagine they experienced a headache while taking Molair. Finally, they rated whether the headache was a side effect (misattribution) and if they would stop taking Molair (behavioral intention). RESULTS: Nearly a quarter (170) of participants misattributed the headache to Molair and 69 (10%) subsequently intended to stop Molair. Both outcomes were predicted by general and specific medication beliefs. Odds of misattribution (m) and behavioral intention (i) increased with higher General Harm (ORm=1.90, ORi=2.72), General Overuse (ORm=1.74, ORi=1.56) and Molair Concern beliefs (ORm=1.52, ORi=1.78, all p<.01), but decreased with General Benefit (ORm=0.72, ORi=0.53) and Molair Necessity beliefs (ORm=0.72, ORi=0.70, all p<.05). CONCLUSION: Symptom misattribution and subsequent intentions to stop Molair were predicted by pre-exposure beliefs about medicines in general and post-exposure beliefs about Molair. Patients with negative medication beliefs may be prone to misattribute symptoms and subsequently stop medication.

Applying a perceptions and practicalities approach to understanding nonadherence to antiepileptic drugs.

OBJECTIVE: Nonadherence to antiepileptic drugs (AEDs) is a common cause of poor seizure control. This study examines whether reported adherence to AEDs is related to variables identified in the National Institute for Health and Clinical Excellence (NICE) Medicines Adherence Guidelines as being important to adherence: perceptual factors (AED necessity beliefs and concerns), practical factors (limitations in capability and resources), and perceptions of involvement in treatment decisions. METHODS: This was a cross-sectional study of people with epilepsy receiving AEDs. Participants completed an online survey hosted by the Epilepsy Society (n = 1,010), or as an audit during inpatient admission (n = 118). Validated questionnaires, adapted for epilepsy, assessed reported adherence to AEDs (Medication Adherence Report Scale [MARS]), perceptions of AEDs (Beliefs about Medicines Questionnaire [BMQ]), and patient perceptions of involvement in treatment decisions (Treatment Empowerment Scale [TES]). RESULTS: Low adherence was related to AED beliefs (doubts about necessity: t(577) = 3.90, p < 0.001; and concerns: t(995) = 3.45, p = 0.001), reported limitations in capability and resources (t(589) = 7.78, p < 0.001), and to perceptions of a lack of involvement in treatment decisions (t(623) = 4.48, p < 0.001). In multiple logistic regression analyses, these factors significantly (p < 0.001) increased variance in reported adherence, above that which could be explained by age and clinical variables (seizure frequency, type, epilepsy duration, number of AEDs prescribed). SIGNIFICANCE: Variables identified in the NICE Medicines Adherence Guidelines as potentially important factors for adherence were found to be related to adherence to AEDs. These factors are potentially modifiable. Interventions to support optimal adherence to AEDs should be tailored to address doubts about AED necessity and concerns about harm, and to overcome practical difficulties, while engaging patients in treatment decisions.

Changing adherence-related beliefs about ICS maintenance treatment for asthma: feasibility study of an intervention delivered by asthma nurse specialists.

OBJECTIVES: The Necessity-Concerns Framework (NCF) posits that non-adherence to inhaled corticosteroids (ICS) in asthma is influenced by doubts about the necessity for ICS and concerns about their potential adverse effects. This feasibility study examined whether these beliefs could be changed by briefing asthma nurse specialists on ways of addressing necessity beliefs and concerns within consultations. DESIGN: Pre-post intervention study. SETTING: Secondary care. PARTICIPANTS: Patients with a diagnosis of moderate to severe asthma who were prescribed daily ICS were recruited to either a hospital care group (n=79; 71.0% female) or intervention group (n=57; 66.7% female). INTERVENTION: Asthma nurse specialists attended a 1.5-day NCF briefing. PRIMARY AND SECONDARY OUTCOME MEASURES: Beliefs about ICS (primary outcome) and self-reported adherence were measured preconsultation and 1 month postconsultation. Participants also rated their satisfaction with their consultations immediately after the consultation. Consultation recordings were coded to assess intervention delivery. RESULTS: After the NCF briefing, nurse specialists elicited and addressed beliefs about medicine more frequently. The frequency of using the NCF remained low, for example, open questions eliciting adherence were used in 0/59 hospital care versus 14/49 (28.6%) intervention consultations. Doubts about personal necessity for, and concerns about, ICS were reduced at 1 month postbriefing (p<0.05), but the intervention was not applied extensively enough to improve adherence. CONCLUSIONS: The intervention changed nurse consultations, but not sufficiently enough to fully address non-adherence or adherence-related ICS beliefs (necessity and concerns). More effective techniques are needed to support nurse specialists and other practitioners to apply the intervention in hospital asthma review consultations.

Understanding patients' adherence-related beliefs about medicines prescribed for long-term conditions: a meta-analytic review of the Necessity-Concerns Framework.

BACKGROUND: Patients' beliefs about treatment influence treatment engagement and adherence. The Necessity-Concerns Framework postulates that adherence is influenced by implicit judgements of personal need for the treatment (necessity beliefs) and concerns about the potential adverse consequences of taking it. OBJECTIVE: To assess the utility of the NCF in explaining nonadherence to prescribed medicines. DATA SOURCES: We searched EMBASE, Medline, PsycInfo, CDSR/DARE/CCT and CINAHL from January 1999 to April 2013 and handsearched reference sections from relevant articles. STUDY ELIGIBILITY CRITERIA: Studies using the Beliefs about Medicines Questionnaire (BMQ) to examine perceptions of personal necessity for medication and concerns about potential adverse effects, in relation to a measure of adherence to medication. PARTICIPANTS: Patients with long-term conditions. STUDY APPRAISAL AND SYNTHESIS METHODS: Systematic review and meta-analysis of methodological quality was assessed by two independent reviewers. We pooled odds ratios for adherence using random effects models. RESULTS: We identified 3777 studies, of which 94 (N = 25,072) fulfilled the inclusion criteria. Across studies, higher adherence was associated with stronger perceptions of necessity of treatment, OR = 1.742, 95% CI [1.569, 1.934], p<0.0001, and fewer Concerns about treatment, OR = 0.504, 95% CI: [0.450, 0.564], p<0.0001. These relationships remained significant when data were stratified by study size, the country in which the research was conducted and the type of adherence measure used. LIMITATIONS: Few prospective longitudinal studies using objective adherence measures were identified. CONCLUSIONS: The Necessity-Concerns Framework is a useful conceptual model for understanding patients' perspectives on prescribed medicines. Taking account of patients' necessity beliefs and concerns could enhance the quality of prescribing by helping clinicians to engage patients in treatment decisions and support optimal adherence to appropriate prescriptions.

Medication nonadherence and psychiatry.

PURPOSE OF REVIEW: Nonadherence to appropriately prescribed medication for psychiatric disorders prevents patients from realizing the full benefits of their treatment and negatively impacts on individuals, their families and the healthcare system. Understanding and reducing nonadherence is therefore a key challenge to quality care for patients with psychiatric disorders. This review highlights findings regarding the prevalence and consequence of nonadherence, barriers to adherence and new intervention methods from 2012 onwards. RECENT FINDINGS: Recent research has highlighted that nonadherence is a global challenge for psychiatry and has linked nonadherence to poorer outcomes, including hospital admissions, suicide and mortality. Optimizing medication regimens can reduce nonadherence; however, often a complex interplay of factors affects individuals' motivation and ability to follow their prescription. Psychiatrists can enable patients to develop an accurate model of their illness and treatment and facilitate adherence. However, nonadherence is often a hidden issue within consultations. Novel interventions using new technologies and tailoring techniques may have the potential to reduce nonadherence. SUMMARY: Nonadherence remains a significant challenge for patients with psychiatric disorders, physicians and healthcare systems. New developments demonstrate the importance of developing tailored interventions to enable patients to overcome perceptual and practical barriers to adherence.

Cognitive processing in putative functional gastrointestinal disorder: rumination yields orientation to social threat not pain.

Two possible roles of selective attention in the development and maintenance of functional gastrointestinal disorders (FGID) such as irritable bowel syndrome (IBS) were examined. First, hypervigilance to pain within FGID may exacerbate pain perception and pain-related distress. Second, hypervigilance to socially threatening stimuli could account for the disrupted social functioning reported by patients. Furthermore, stress-related variations in reported symptom severity and functioning impairments may reflect changes in cognitive bias with psychological state. Patterns of selective attention were probed within a sample of putative FGID participants (pFGID). The effect of rumination induction on performance on a modified exogenous cueing task was examined. Thirty-three women with pFGID and 27 matched controls responded to dot probes following pain, social threat and neutral word cues, both before and after rumination (passive self-focused thought), or distraction induction. Reaction times revealed that after rumination but not neutral distraction, pFGID participants showed enhanced attention to social threat words, but not to pain or neutral words. Between-group differences in mood, anxiety or depression could not account for these effects. These results implicate selective attention in social but not pain-related idiosyncrasies in FGID including IBS.