Summary Background: Vaccinations often elicit significant distress in school-aged children, which can impact pain perception and future medical experiences. This study examined the effects of three stages of a video-based magic intervention on self-reported distress and pain in children receiving HPV vaccinations. Methods: This cluster-randomized controlled trial randomized 412 children (aged 9–11 years) who received their first HPV vaccination at five mass-vaccination sites in The Netherlands. Based on vaccination date and time, children were assigned to one of four groups: 1. watching a magic trick video during the vaccination, 2. watching the trick with revelation of the secret, 3. watching the trick with revelation of the secret, followed by a brief post-vaccination video-training, and 4. a regular care control. Children completed questionnaires before (T0) and after (T1) the first vaccination in April 2024, and before the second vaccination six months later (T2) in September/October 2024. The primary outcome of child-reported distress was assessed at T0, T1, and T2 using the Facial Image Scale (FIS) and the short form of the State-Trait Anxiety Inventory (STAI-6). The study was preregistered on OSF (https://doi.org/10.17605/OSF.IO/5ASM9, registered April 4, 2024). Findings: All randomized participants were analyzed according to the intention-to-treat principle. Children in the combined magic-intervention groups (groups 1–3) reported less distress and lower pain after the first vaccination compared to the control group (group 4; distress: p < 0.0001, partial η2 = 0.11; pain: p = 0.0039, η2 = 0.02, 95% CI [0.002–0.058]). The most extensive magic intervention (group 3) showed the largest distress reduction as compared to all other groups (p < 0.0001). No significant differences in distress were observed preceding the second vaccination, indicating a lack of sustained effects. Interpretation: The video-based magic intervention reduced distress and pain immediately following the vaccination, with the largest effect found for the most elaborate intervention group involving active engagement. These findings suggest a promising, easily implementable intervention to improve children’s vaccination experiences during mass vaccinations. Funding: LUMC Foundation (non-profit).

Background: Remote patient management (RPM) using smartphone-enabled health monitoring devices (SHMDs) can be an effective, value-added part of cardiovascular care. However, cardiac patients’ adherence to RPM is variable. Personas are fictional representations of users with common behaviors, needs, and motivation and can thereby help guide tailoring of interventions to be meaningful and possibly more effective. Personas can be used to understand the needs of the patient group and guide tailoring toward more personalized and effective eHealth intervention. Objective: The aim of this study was to develop data-driven personas for patients with myocardial infarction (MI) based on both quantitative and qualitative results. Methods: This study used a mixed methods design involving (1) database analysis of patients with MI (N=261) SHMD usage data (blood pressure [BP], weight, step count) over the course of a one-year care track and (2) semistructured interviews with patients with MI (N=16) currently using SHMDs. Overall, 12-month adherence rates were calculated based on the number of weeks patients performed the prescribed home measurements with the SHMDs. Results: A cluster analysis was conducted on the self-monitoring data resulting in four distinctive usage patterns labeled as stiff starting (low adherent in first 6 weeks: 13%, 34/261 of users), temporary persisting (decreasing adherence: 24%, 62/261), loyally persisting (continuously adherent: 26%, 68/261), and negligent quitting (nonadherent: 37%, 97/261). Health outcomes (BP, step count, and weight) were analyzed based on these patterns. More adherent usage patterns show better controlled BP when compared to less adherent usage patterns, suggesting that adherence is associated with health outcomes. Patient experiences regarding adherence or nonadherence to the RPM relating to the four distinctive usage patterns were uncovered by means of semistructured interviews, providing insight into adherence factors most relevant for each of the clusters. Thus, 4 distinct personas were developed by data collection (database analysis and semistructured interviews), persona segmentation, and persona creation, named Tamara, Sam, Peter, and Kim. Conclusions: This study identified 4 personas regarding adherence experiences and usage patterns of patients within an RPM care track. Adherent usage patterns were characterized by improved BP and step count. These personas can guide future tailoring of eHealth interventions to maximize patient adherence.

Complex eHealth interventions - featuring multiple components within dynamic systems - are used for healthcare improvement. Public-private partnerships (PPPs), combining resources, expertise, and technology, are crucial in this context. Yet, integrating these interventions into practice remains challenging. This study identifies barriers and facilitators affecting implementation of the BENEFIT programme, a complex eHealth intervention targeting cardiovascular disease patients, by PPP within practice. A qualitative study design was employed. Ten key stakeholders from four cardiac rehabilitation (CR) sites, who were all PPP partners involved in developing and implementing the BENEFIT programme, were interviewed semistructured. Transcripts were analysed using Consolidated Framework for Implementation Research. Facilitators included programme adaptability, communication and planning within teams, digital healthcare needs, dedicated PPP leadership, PPP meeting structure and PPP's ability to quickly modify the implementation strategy. Barriers involved specific PPP challenges (frequently changing roles, unclear roles and responsibilities and limited staffing), workplace disruptions, poor information technology (IT) integration, and ambiguous implementation goals amongst CR sites. This case study highlights challenges in implementing complex eHealth interventions by PPPs within practice. The findings underscore the need for a comprehensive implementation approach considering specific PPP dynamics, including combined expertise and resources, transparent role definition, sufficient staffing, clear goal communication and adaptable strategies for sustainable implementation.

Importance: General practitioners (GPs) sometimes initiate a treatment despite not expecting it to improve patients' symptoms by any physiological mechanism. These essentially placebo treatments are ethically controversial, and their frequency is unclear. They involve risks for patients, but to estimate these, more data are needed. Objective: To develop a more precise overview of the rate at which GPs prescribe essentially placebo treatments. Design, Setting, and Participants: This cross-sectional survey study included currently practicing GPs from 20 European countries and Israel who responded to online questionnaires. The online questionnaires were taken between December 12, 2019, and August 4, 2021, and analyzed on April 28, 2022. Respondents were contacted by national representatives, either through personal networks (convenience sampling) or an existing database (volunteer sampling). Main Outcomes and Measures: The main outcome was the rate of essentially placebo prescriptions, given as the rate per week and the proportion of consultations. Secondary outcomes were the associations between this rate and GP background characteristics (gender, age, education about placebos, years of experience, patients seen, and working hours per week). Results: A total of 952 practicing GPs responded (453 of 745 [61%] female; mean [SD] age of 48.02 [11.95] years), and 669 answered all questions. Overall, 689 of 818 respondents (84%) indicated they had prescribed an essentially placebo treatment at least once. Overall, the median (IQR) rate of essentially placebo prescriptions was 0.5 (0.1 to 2.0) per week or 0.67% (0.06% to 2.50%) of consultations. The prescription rate was higher in men (β = 1.94 [95% CI, 0.58 to 3.29]; P = .005), those with more work experience (β = 0.12 [95% CI, 0.06 to 0.18]; P < .001), and those who work fewer hours per week (β = -0.08 [95% CI, -0.13 to -0.03]; P = .001). Conclusions and Relevance: In this survey study of GPs across 21 countries, essentially placebo prescriptions featured in a small minority of consultations, but they nevertheless occurred regularly for most GPs. Rates varied only slightly by GP background characteristics. This suggests that essentially placebo prescriptions were common at a population level, which poses risks for the patient-GP relationship and creates medical risks for patients. Future research should further investigate the decision-making process behind these prescriptions and their effects on patients.

Objectives: Placebo effects can relieve acute and chronic pain in both research and clinical treatments by learning mechanisms. However, the application of placebo-based treatment strategies in routine medical care is questioned. The current study investigated the opinions of patients with fibromyalgia and healthy controls regarding learning of placebo effects and their practical applications. Method: An online survey asked 158 age- and sex-matched adult patients and controls (79 per group) to rate the perceived influence of various placebo learning mechanisms on pain relief, and the acceptability and perceived effectiveness of placebo-based strategies (open-label, closed-label, dose-extending, and treatment-enhancing strategies). Respondents' knowledge about placebo effects was obtained through a 7-item quiz. Results: The groups did not differ in the perceived influence of placebo learning mechanisms on pain relief (p = 0.217). Controls considered closed-label and treatment-enhancing strategies more acceptable than patients (p = 0.003 and p < 0.001), whereas controls perceived all strategies more effective. In both groups, closed-label strategies were significantly less acceptable than any other strategy (p-values < 0.001), and treatment-enhancing or dose-extending strategies were most acceptable. Higher acceptability was predicted by higher perceived effectiveness ratings (p < 0.001). Also, increased placebo knowledge was related to higher acceptability (p = 0.03) and perceived effectiveness (p < 0.001). Discussion: This survey suggests that both the medical history of patients and knowledge about placebo effects affect the acceptability and perceived effectiveness of placebo-based strategies. Furthermore, strategies that are transparent, assumed effective, or combined with existing medical treatments are deemed most acceptable. Keeping these factors in mind is essential for the clinical implementation of placebo-based strategies in routine medical care.

Objective: Expectancies are known to shape pain experiences, but it remains unclear how different types of expectancies contribute to daily pain fluctuations in fibromyalgia. This combined experimental and diary study aims to provide insights into how experimentally-derived nocebo hyperalgesia and other, diary-derived, expectancy-related factors are associated with each other and with daily pain in fibromyalgia. Methods: Forty-one female patients with fibromyalgia first participated in a lab procedure measuring nocebo hyperalgesia magnitude, then filled out an electronic diary 3 times a day over 3 weeks regarding the expectancy-related factors of pain expectancy, anxiety, optimism, and pain-catastrophizing thoughts, and current pain intensity. Results: Our results indicate that experimentally-induced nocebo hyperalgesia was not significantly related to diary-assessed expectancy-related factors and did not predict daily fibromyalgia pain. Higher levels of the self-reported expectancy-related factors pain expectancy and pain catastrophizing, but not anxiety and optimism, predicted moment-to-moment pain increases in fibromyalgia, after controlling for current pain, moment-of-day and all other expectancy-related factors. Conclusion: Our exploratory research findings indicate that self-reported expectancy-related factors, particularly pain expectancy and pain catastrophizing, are potentially more relevant for predicting daily pain experience than experimentally-induced nocebo hyperalgesia. Further translation of nocebo hyperalgesia is needed from experimental to Ecological Momentary Assessment research. Our findings imply that targeting the decrease in pain expectancy and catastrophizing thoughts e.g., via Cognitive Behavioral Therapy, have potential for improving daily pain levels in fibromyalgia.

Background: Financial incentives are a promising tool to help people increase their physical activity, but they are expensive to provide. Deposit contracts are a type of financial incentive in which participants pledge their own money. However, low uptake is a crucial obstacle to the large-scale implementation of deposit contracts. Therefore, we investigated whether (1) matching the deposit 1:1 (doubling what is deposited) and (2) allowing for customizable deposit amounts increased the uptake and short term effectiveness of a deposit contract for physical activity. Methods: In this randomized controlled trial, 137 healthy students (age M = 21.6 years) downloaded a smartphone app that provided them with a tailored step goal and then randomized them to one of four experimental conditions. The deposit contract required either a €10 fixed deposit or a customizable deposit with any amount between €1 and €20 upfront. Furthermore, the deposit was either not matched or 1:1 matched (doubled) with a reward provided by the experiment. During 20 intervention days, daily feedback on goal progress and incentive earnings was provided by the app. We investigated effects on the uptake (measured as agreeing to participate and paying the deposit) and effectiveness of behavioral adoption (measured as participant days goal achieved). Findings: Overall, the uptake of deposit contracts was 83.2%, and participants (n = 113) achieved 14.9 out of 20 daily step goals. A binary logistic regression showed that uptake odds were 4.08 times higher when a deposit was matched (p = .010) compared to when it was not matched. Furthermore, uptake odds were 3.53 times higher when a deposit was customizable (p = .022) compared to when it was fixed. Two-way ANCOVA showed that matching (p = .752) and customization (p = .143) did not impact intervention effectiveness. However, we did find a marginally significant interaction effect of deposit matching X deposit customization (p = .063, ηp2 = 0.032). Customization decreased effectiveness when deposits were not matched (p = .033, ηp2 = 0.089), but had no effect when deposits were matched (p = .776, ηp2 = 0.001). Conclusions: We provide the first experimental evidence that both matching and customization increase the uptake of a deposit contract for physical activity. We recommend considering both matching and customization to overcome lack of uptake, with a preference for customization since matching a deposit imposes significant additional costs. However, since we found indications that customizable deposits might reduce effectiveness (when the deposits are not matched), we urge for more research on the effectiveness of customizable deposit contracts. Finally, future research should investigate which participant characteristics are predictive of deposit contract uptake and effectiveness. Pre-registration: OSF Registries, https://osf.io/cgq48.