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Generic medicines have been associated with less efficacy compared to originator products. Educational videos explaining generic medicines can have a positive effect on perceptions of generic drugs and their pain-relieving effect. The central aim of the current study was to examine whether trust in the governmental approval process of medicines mediates the effect of educational video interventions on the pain-relieving effect induced by a generic medicine and whether trust can be built by improving individuals' understanding of generic medication. This is a secondary analysis of a randomized controlled trial where participants with frequent tension headaches were randomly assigned to either watching a video explaining generic drugs (n = 69) or a video informing about headaches (control group: n = 34). After watching the video, participants took an originator and a generic pain analgesic in a randomized order to treat their next two consecutive headaches. Pain severity was measured before and 1 h after taking the medicine. A multiple serial mediator model showed that improving individuals' understanding of generic medicines is associated with increased trust in medicines. Both factors together, understanding and trust, significantly mediated the effect of the video education about generic drugs on the generic's pain-relieving effect (total indirect effect: coefficient: 0.20, 95% CI: 0.42, −0.0001). Results of this study show that improving individuals' understanding of generic medication and trust in the process of approving medicines should be considered as important mechanisms of future educational interventions about generic medicines. • Educational videos on generic drugs can increase individuals' trust in medicines. • Educational videos can improve individuals' understanding of generic medicines. • Individuals' understanding of medicines and trust in medicines are associated. • Understanding of and trust in generics are mechanisms educational videos' effects. [ABSTRACT FROM AUTHOR]

As more biosimilars enter the pharmaceutical market, patient acceptance remains a significant barrier to their uptake. Psychological factors, such as negative expectations, are important causes of patient hesitancy. As a result, patients can develop nocebo responses following a transition, discontinue biosimilar treatment early, or have poor adherence. These negative outcomes may offset some of the cost-saving potential of biosimilars. Key healthcare professionals such as pharmacists, physicians, and nurses already play a noteworthy role in educating and transitioning patients. However, given the psychological aspect of biosimilar acceptance, it is logical for healthcare professionals and researchers to draw on research and theory from health psychology. This commentary outlines how a multidisciplinary approach can add to the understanding of the mechanisms behind patient resistance to biosimilars and help engage patients in the transitioning process. It also explores how health psychology strategies that have been successful in similar areas can be translated to help conduct more effective transitions. Future directions in research are discussed. [ABSTRACT FROM AUTHOR]

Background: Generic medicines have been associated with less perceived efficacy and more side effects compared to brand name drugs. Educational interventions to improve individuals' negative perceptions of generic medicines show contradictory effects.Objective: This study investigated whether an interventional video that informs about the approval process of releasing medicines has better effects on outcomes related to perceptions and effectiveness of generic medicines in participants with headaches, in comparison with another interventional video that addresses bioequivalence between brand name and generic drugs or a control video.Methods: Participants with frequent tension headaches were randomized to one of three groups (one of two interventional videos or the control video). One of the interventional videos explained the process of approval of generic medicines (n = 34), the other one explained the bioequivalence between brand name and generic drugs (n = 35). The control video informed participants about the epidemiology and etiology of headaches (n = 34). After watching the video, participants treated their next two consecutive episodes of headache with a brand name and a generic analgesic in randomized order.Main Outcome Measures: Self-report measures of understanding and perceptions of and preference for medicines, pain severity and side effects.Results: Linear mixed models showed that both interventional videos improved participants' understanding of generic medicines. The generic drug approval process video enhanced the perceived effectiveness, safety and quality of generic drugs. The bioequivalence video positively influenced the preference for generic drugs. The brand name and generic drug were equally effective in relieving pain in participants who watched either the generic drug approval process or the bioequivalence video.Conclusions: Information about both, approving a switch from brand name medicines to generic counterparts and bioequivalence, can be important and should be addressed in future educational interventions. [ABSTRACT FROM AUTHOR]

Treatment expectations alter the probability of experiencing unpleasant side effects from an intervention, including vaccinations. To date, expectations have mostly been assessed explicitly bearing the risk of bias. This study aims to compare implicit expectations of side effects from COVID-19 and flu vaccinations and to examine their relationships with vaccine attitudes and intentions. N = 248 participants took part in a cross-sectional online survey assessing explicit and implicit expectations, as well as vaccine-related attitudes and personal characteristics. A Single Category Implicit Association Test (SC-IAT) was developed to assess implicit side effect expectations. Explicit side effect expectations were measured with the Treatment Expectation Questionnaire (TEX-Q). Whereas explicit and implicit expectations regarding COVID-19 vaccine were significantly correlated (r = −0.325, p <.001), those correlations could not be found regarding flu vaccine (r = −0.072, p =.32). Explicit measures (COVID-19: β = −0.576, p <.001; flu: β = −0.301, p <.001) predicted the intention to receive further vaccinations more than implicit measures (COVID-19: β = −0.005, p =.93; flu: β = 0.004, p =.96). Explicit measures (COVID-19: OR = 0.360, p <.001; flu: OR = 0.819, p =.03) predicted vaccination status, while implicit measures did not (COVID- 19: OR = 2.643, p =.35; flu: OR = 0.829, p =.61). Expectations to experience side effects from vaccinations can be measured implicitly, in addition to explicit measures. Further investigation needs to determine the relative contribution and additive value of using implicit measures to assess treatment expectations. • An implicit measure assessing expectations of vaccination side effects was developed. • Implicit side effect expectation measures can be used in addition to explicit measures. • Both measures correlated positively for COVID-19, not for flu. • Explicit expectations seem more predictive of vaccination intention and status. [ABSTRACT FROM AUTHOR]

Objective: To examine if insomnia before and after childbirth predicts the development of postpartum bodily pain.Methods: This study is part of a longitudinal cohort study, the Akershus Birth Cohort Study, which targeted all women giving birth at Akershus University Hospital in Norway. The current sample is comprised of 1480 women who participated at all three time points, yielding a participation rate of 32% of the 4662 women who originally consented to participate. The Bergen Insomnia Scale (BIS) was used to measure insomnia and a latent profile analysis (LPA) was used to identify subsets of women who shared a similar pattern of responses on the BIS-scale across the three time points. Pain was measured using the bodily pain scale, derived from the Primary Care Evaluation of Mental Disorders (PRIME-MD) and symptoms of depression were measured by the Edinburgh Postnatal Depression Scale (EPDS).Results: Using a latent profile analysis a three class model showed the best fit and identified one major group (55.6%) with a low BIS scores across all three time points, one group with intermediate BIS scores (32.9%), and a smaller group (11.5%) with higher BIS scores across all three times. The chronic high insomnia group had a 2.8-fold increased risk of reporting high levels of bodily pain. The chronic intermediate group was associated with a 2.2-fold increased risk of bodily pain at two years postpartum. Adjusting for demographics and lifestyle behaviors did not reduce any of the associations, while adjusting for depression significantly attenuated the associations. Additional adjustment for pain at eight weeks postpartum further reduced the magnitude of the associations, but both chronic intermediate insomnia and chronic high insomnia remained strongly associated with the onset of bodily pain in the fully adjusted models (RR=1.75, 95% CI: 1.37-2.23) and RR=1.63, 95% CI: 1.15-2.32, respectively).Conclusions: The high prevalence of insomnia among women during and after childbirth, in combination with the strong prospective association with impaired physical health, emphasizes the importance of adequately identifying, preventing and treating insomnia for this population. [ABSTRACT FROM AUTHOR]

Objective The Internet has expanded the scope for creating health scares and increased the risk of nocebo responding in individuals exposed to misinformation about threats to personal health posed by aspects of modern life, such as exposure to new technologies. It was the aim of this experiment to investigate whether the delivery of positive expectations might reduce or reverse symptoms triggered by negative expectations formed from such misinformation. Method In the context of a study investigating symptoms during exposure to windfarm sound, 64 volunteers assessed their symptomatic experiences during two discrete sessions, throughout which they listened to wind turbine sound containing audible and sub-audible (infrasound) components. Participants were randomly assigned to watch either positive or negative information about the health effects of infrasound prior to their first infrasound exposure session. They were then shown the alternate information and exposed to infrasound during their second session. Results Participants receiving negative expectations were less symptomatic during exposure if they had previously received positive expectations about infrasound. Further, participants given positive expectations after the earlier delivery of negative expectations exhibited a placebo response, reversing the nocebo response exhibited in their first exposure session. Conclusion Results suggest accessing positively framed health information may reverse or dilute the effect of negative expectations formed from exposure to media warnings about health risks posed by new technologies, such as wind turbines. [ABSTRACT FROM AUTHOR]

Objective: The nocebo effect is the adverse effects of treatment that cannot be attributed to a medicine. We investigated if we could increase or decrease nocebo responding following medicine taking. A nocebo explanation to reduce side effects was compared with a negative medication news item designed to increase side effects and a control condition.Methods: 108 healthy participants enrolled in a between-subjects study purportedly testing the effect of lamotrigine (actually placebo) on mood and cognition. Participants were randomised to watch either a video explaining the nocebo effect; a negative media item on lamotrigine, or control video prior to receiving the tablet. Side effects were assessed at 45-min and 48-h.Results: The negative media group reported significantly more side effects (M = 0.78, SD = 1.53) than the control group (M = 0.46, SD = 1.80, p = .035) at the end of session and a greater proportion of the negative media group (33%) reported at least one side effect compared to the nocebo explanation (11%) and control group (11%, p = .020). The nocebo explanation group reported significantly fewer side effects (M = 0.38, SD = 1.16) than the control group (M = 1.37, SD = 2.98, p = .038) at the 48-h follow-up.Conclusion: Explaining the nocebo effect may be a beneficial addition to standard medicine information for reducing side effect reporting. Negative media coverage about a drug is likely to generate increased side effects. Future research should examine the benefit of nocebo explanation in patients starting new medicines. [ABSTRACT FROM AUTHOR]

Objective: Adherence continues to be a major challenge in healthcare but there is still limited understanding of all the factors which can influence adherence behaviour. The present study was designed to identify a range of factors associated with intentional non-adherence and to see if they could be formed into a psychometrically sound scale.Methods: Patients in three different clinical groups (Hypertension (N = 175); Oncology (N = 115); Gout (N = 196)) were given the new scale together with an adherence self-report and/or biomarker measure. Other, more established measures of factors known to be associated with adherence (BMQ, PAM, BIPQ), were also completed by patients for comparative and validation purposes. Exploratory Factor Analysis (EFA) was conducted to examine the factor structure of the new scale, and other statistical analyses were used for testing the psychometric properties of the new scale.Results: EFA revealed two factors, which were labelled "Resisting illness" and "Testing treatment". Both scales were found to have good psychometric properties and explained unique variance in adherence in all three clinical groups.Conclusion: This new scale shows promise in describing and explaining some relatively novel factors underlying treatment non-adherence. Further work in different patient groups and clinical contexts is needed to confirm the factor structure and predictive value of these scales. [ABSTRACT FROM AUTHOR]

Objective: Failure to effectively reassure patients can lead to patients becoming distressed and seeking further medical care. Whilst existing studies have identified that patients' psychological and demographic characteristics can impact patient reassurance, little research has explored specific predictors of patient reassurance following a colonoscopy. This study investigates demographic and psychological predictors of patient reassurance after receiving normal test results following a colonoscopy.Methods: Eighty-five participants receiving colonoscopies due to gastrointestinal symptoms were recruited from two endoscopy clinics. Patients provided demographic information and completed questionnaires assessing illness perceptions, health-related anxiety, hypochondriasis, somatisation and state and trait anxiety prior to the colonoscopy, as well as reassurance the day after the colonoscopy. Seventy-three participants provided complete data and were included in the analyses. Pearson's correlations and hierarchical linear regression were conducted to examine the associations between the baseline variables and patient reassurance after the colonoscopy.Results: Health-related anxiety, hypochondriasis and four items from the Brief Illness Perceptions Questionnaire (consequence, identity, concern, and emotional response beliefs) were negatively correlated with reassurance (r's ranged from -0.28 to -0.54, P < .05). The hierarchical linear regression demonstrated that in the fully adjusted model, only consequence beliefs (i.e. negative beliefs regarding the impact of gastrointestinal symptoms) remained a robust predictor of reassurance (β = -0.56, P = .005).Conclusion: This study extends existing research on patient reassurance and is the first study to demonstrate that illness beliefs predicted reassurance following a colonoscopy. These findings suggest that targeting consequence beliefs may be a useful intervention for improving patient reassurance following clinical investigations. [ABSTRACT FROM AUTHOR]

Objectives: Symptom misattribution is a central process in the nocebo effect but it is not accurately assessed in current side effect measures. We have developed a new measure, the Side Effect Attribution Scale (SEAS), which examines the degree to which people believe their symptoms are treatment side effects.Methods: The SEAS was tested in three New Zealand studies: a vaccination sample (n = 225), patients with gout or rheumatoid arthritis (n = 102), and patients switching to a generic medicine (n = 69). The internal reliability of the scale was examined using Cronbach's alpha. To assess validity, the Side Effect Attribution Total Score and Side Effect Attribution Binary Score were related to a number of psychological measures associated with side effect reporting.Results: The scale showed good internal reliability across the three studies, with Cronbach alphas ranging from 0.840 to 0.943. Analysis of the effect sizes showed that the Attribution Total Score was generally more strongly associated with nocebo responding than Attribution Binary Score. Participants had greater Side Effect Attribution Total Scores if they had higher expectations for vaccination side effects (r = 0.18, p = .028), more worry about future vaccine effects (r = 0.16, p = .046), a higher perceived sensitivity to medicines (r = 0.50, p < .001), greater anxiety (r = 0.25, p = .016), greater intentional non-adherence (r = 0.30, p = .003), greater medicine information seeking (r = 0.26, p = .010), lower trust in pharmaceutical agencies (r = -0.29, p = .026), and lower medicine efficacy beliefs (r = -0.46, p < .001).Conclusions: The SEAS provides a more nuanced assessment of symptom attribution beliefs. It appears to be more sensitive measure than just a side effect total, as it is associated with a greater number of relevant psychological variables. Future research should examine the scale in other populations and settings. [ABSTRACT FROM AUTHOR]