A.W.M. Evers
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88 records found
1
Placebo and nocebo in clinical practice
An online cross-sectional survey of healthcare professionals from European countries on views, practices and training needs
“Magical relief”
The effectiveness of three stages of a video-based magic intervention on distress and pain in children aged 9–11 years during HPV mass vaccinations—a cluster-randomized trial
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).
The overwhelming evidence of nocebo effects adversely affecting the experience of physical symptoms, such as pain, puts emphasis on the study of possible strategies to reduce nocebo effects. Counterconditioning, during which a previously conditioned effect is reversed, has been shown to be a possible promising strategy in a previous study in an open-label design, in which people were informed about the use of inert treatments and the counterconditioning procedure. However, it is unclear whether open-label counterconditioning is as effective as closed-label procedures in comparison to extinction.
Methods
In a randomised controlled trial, we investigated in 66 healthy female participants whether conditioned nocebo effects on pressure pain can be reduced via open-label counterconditioning, closed-label counterconditioning, or extinction.
Results
A significant reduction of nocebo effects was found after open-label counterconditioning (d = 1.13), closed-label counterconditioning (d = 0.69), and extinction (d = 0.66). Open-label counterconditioning was more effective than extinction (d = 0.85), reversed the nocebo effect, and also resulted in a placebo effect. Closed-label counterconditioning was more effective than extinction (d = 0.45) in the sensitivity analyses of nocebo responders only. Finally, larger placebo expectancies predicted a higher response to the open- and closed-label counterconditioning procedures, but not extinction.
Conclusions
These results show that particularly open-label counterconditioning is an effective method to modulate nocebo effects on pressure pain. This provides promise in designing non-deceptive learning-based treatments to reduce nocebo effects in diverse patient groups, including chronic pain disorders.
Significance Statement
Few studies have investigated the efficacy open-label counterconditioning to reduce nocebo effects or have compared it to deceptive reduction strategies. The current study demonstrates that open-label counterconditioning is as effective as more deceptive nocebo-reducing strategies and may thus be a promising new method for reducing nocebo effects in a non-deceptive and ethical manner. Results can be helpful while designing learning-based treatments to reduce nocebo effects in patients with, for example, chronic pain disorders. ...
The overwhelming evidence of nocebo effects adversely affecting the experience of physical symptoms, such as pain, puts emphasis on the study of possible strategies to reduce nocebo effects. Counterconditioning, during which a previously conditioned effect is reversed, has been shown to be a possible promising strategy in a previous study in an open-label design, in which people were informed about the use of inert treatments and the counterconditioning procedure. However, it is unclear whether open-label counterconditioning is as effective as closed-label procedures in comparison to extinction.
Methods
In a randomised controlled trial, we investigated in 66 healthy female participants whether conditioned nocebo effects on pressure pain can be reduced via open-label counterconditioning, closed-label counterconditioning, or extinction.
Results
A significant reduction of nocebo effects was found after open-label counterconditioning (d = 1.13), closed-label counterconditioning (d = 0.69), and extinction (d = 0.66). Open-label counterconditioning was more effective than extinction (d = 0.85), reversed the nocebo effect, and also resulted in a placebo effect. Closed-label counterconditioning was more effective than extinction (d = 0.45) in the sensitivity analyses of nocebo responders only. Finally, larger placebo expectancies predicted a higher response to the open- and closed-label counterconditioning procedures, but not extinction.
Conclusions
These results show that particularly open-label counterconditioning is an effective method to modulate nocebo effects on pressure pain. This provides promise in designing non-deceptive learning-based treatments to reduce nocebo effects in diverse patient groups, including chronic pain disorders.
Significance Statement
Few studies have investigated the efficacy open-label counterconditioning to reduce nocebo effects or have compared it to deceptive reduction strategies. The current study demonstrates that open-label counterconditioning is as effective as more deceptive nocebo-reducing strategies and may thus be a promising new method for reducing nocebo effects in a non-deceptive and ethical manner. Results can be helpful while designing learning-based treatments to reduce nocebo effects in patients with, for example, chronic pain disorders.
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.
Perspective
This article found that negative expectancies can lead to hyperalgesia but not necessarily to more pain avoidance behavior in individuals without chronic pain. Findings from this article support the ample studies indicating that expectancies provide a strong target for pain treatment. ...
Perspective
This article found that negative expectancies can lead to hyperalgesia but not necessarily to more pain avoidance behavior in individuals without chronic pain. Findings from this article support the ample studies indicating that expectancies provide a strong target for pain treatment.
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.
Implementation of a complex eHealth intervention by a public-private partnership in clinical practice
A qualitative multicentre analysis using CFIR
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.
Adherence Patterns of Patients Using Remote Patient Management After Myocardial Infarction
Mixed Methods Persona Approach
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.
Content evaluation of the inclusive eHealth guide
How to develop interventions for people with a lower socioeconomic position?
Methods: This mixed-method study used qualitative research through semi-structured interviews and the think-aloud method with 13 professionals involved in eight different eHealth lifestyle interventions using the eHealth guide. Quantitative feedback was obtained through a survey with evaluative multiple-choice questions. Participants evaluated the IeG at various stages. They identified positive aspects and points for improvement, and provided recommendations for the guide's content and structure.
Results: Participants valued the IeG's practicality and comprehensiveness, noting its usefulness in developing accessible eHealth solutions for populations with lower SEP. They suggested improving content clarity, expanding informational depth, and refining the guide's structure.
Conclusions: The IeG has potential as a valuable tool for professionals developing eHealth interventions for lower SEP populations. Continuous refinement is crucial to ensure the guide remains relevant and effective, contributing to reducing health disparities. ...
Methods: This mixed-method study used qualitative research through semi-structured interviews and the think-aloud method with 13 professionals involved in eight different eHealth lifestyle interventions using the eHealth guide. Quantitative feedback was obtained through a survey with evaluative multiple-choice questions. Participants evaluated the IeG at various stages. They identified positive aspects and points for improvement, and provided recommendations for the guide's content and structure.
Results: Participants valued the IeG's practicality and comprehensiveness, noting its usefulness in developing accessible eHealth solutions for populations with lower SEP. They suggested improving content clarity, expanding informational depth, and refining the guide's structure.
Conclusions: The IeG has potential as a valuable tool for professionals developing eHealth interventions for lower SEP populations. Continuous refinement is crucial to ensure the guide remains relevant and effective, contributing to reducing health disparities.
To improve lifestyle guidance within cardiac rehabilitation (CR), a comprehensive understanding of the motivation and lifestyle-supporting needs of patients with cardiovascular disease (CVD) is required.
Objectives
This study's purpose is to evaluate patients’ lifestyle and their motivation, self-efficacy and social support for change when starting CR.
Methods
1782 CVD patients (69 % male, mean age 62 years) from 7 Dutch outpatient CR centers participated between 2020 and 2022. Modifiable risk factors were assessed with a survey and interviews by healthcare professionals during CR intake.
Results
Most patients exhibited an elevated risk in 3–4 domains. Elevated risks were most prominent in domains of (1) waist circumference and BMI (2) physical exercise (3) healthy foods intake and (4) sleep duration. Most patients chose to focus on increasing physical exercise, but about 20 % also wanted to focus on a healthy diet and/or decrease stress levels. Generally, motivation, self-efficacy and social support to reach new lifestyle goals were high. However, patients with an unfavorable risk profile had lower motivation and self-efficacy to work on lifestyle changes, while patients with lower social support had a higher chance to quit the program prematurely.
Conclusions
Our results underscore the need to begin CR with a comprehensive lifestyle assessment and highlight the importance of offering lifestyle interventions tailored to patients’ specific modifiable risk factors and lifestyle-supporting needs, targeting multiple lifestyle domains. Expanding the current scope of CR programs to address diverse patient needs and strengthening support may enhance motivation and adherence and lead to significant long-term benefits for cardiovascular health. ...
To improve lifestyle guidance within cardiac rehabilitation (CR), a comprehensive understanding of the motivation and lifestyle-supporting needs of patients with cardiovascular disease (CVD) is required.
Objectives
This study's purpose is to evaluate patients’ lifestyle and their motivation, self-efficacy and social support for change when starting CR.
Methods
1782 CVD patients (69 % male, mean age 62 years) from 7 Dutch outpatient CR centers participated between 2020 and 2022. Modifiable risk factors were assessed with a survey and interviews by healthcare professionals during CR intake.
Results
Most patients exhibited an elevated risk in 3–4 domains. Elevated risks were most prominent in domains of (1) waist circumference and BMI (2) physical exercise (3) healthy foods intake and (4) sleep duration. Most patients chose to focus on increasing physical exercise, but about 20 % also wanted to focus on a healthy diet and/or decrease stress levels. Generally, motivation, self-efficacy and social support to reach new lifestyle goals were high. However, patients with an unfavorable risk profile had lower motivation and self-efficacy to work on lifestyle changes, while patients with lower social support had a higher chance to quit the program prematurely.
Conclusions
Our results underscore the need to begin CR with a comprehensive lifestyle assessment and highlight the importance of offering lifestyle interventions tailored to patients’ specific modifiable risk factors and lifestyle-supporting needs, targeting multiple lifestyle domains. Expanding the current scope of CR programs to address diverse patient needs and strengthening support may enhance motivation and adherence and lead to significant long-term benefits for cardiovascular health.
Although the multifactorial nature of chronic pain is well established, research has predominantly examined isolated variables or singular pathways that may contribute to this condition. We use a complex systems perspective to examine the interplay of psychological factors in the context of chronic pain.
Methods:
We analyzed 2 cross-sectional data sets (N=935 and 1366) collected at a pain clinic and rehabilitation center in Belgium from individuals primarily with musculoskeletal pain. These included self-reported data on pain-related fear and avoidance beliefs, depression and anxiety symptoms, pain intensity, and disability. We used Gaussian Graphical Models to examine conditional associations between these variables, their relative importance (having more/stronger relationships), and how they are moderated by pain-related fear and pain intensity.
Results:
Our analyses revealed highly interrelated networks, with several unique, positive associations between the included factors. Depressive symptoms and pain intensity were most strongly related to pain disability. Fear-avoidance beliefs featured less prominently than previous studies looking at this concept in isolation have suggested. Apart from differences in 2 associations between samples, and 2 moderation effects of pain intensity in 1 sample, the network structure was similar across the 2 samples.
Discussion:
Overall, our results show that psychological factors related to disability have intricate interrelations, highlighting the complexity of chronic pain and the need to study its many components in relation to each other. The consistency across the 2 samples provides encouraging evidence that the results reflect a stable pattern within this complex system. ...
Although the multifactorial nature of chronic pain is well established, research has predominantly examined isolated variables or singular pathways that may contribute to this condition. We use a complex systems perspective to examine the interplay of psychological factors in the context of chronic pain.
Methods:
We analyzed 2 cross-sectional data sets (N=935 and 1366) collected at a pain clinic and rehabilitation center in Belgium from individuals primarily with musculoskeletal pain. These included self-reported data on pain-related fear and avoidance beliefs, depression and anxiety symptoms, pain intensity, and disability. We used Gaussian Graphical Models to examine conditional associations between these variables, their relative importance (having more/stronger relationships), and how they are moderated by pain-related fear and pain intensity.
Results:
Our analyses revealed highly interrelated networks, with several unique, positive associations between the included factors. Depressive symptoms and pain intensity were most strongly related to pain disability. Fear-avoidance beliefs featured less prominently than previous studies looking at this concept in isolation have suggested. Apart from differences in 2 associations between samples, and 2 moderation effects of pain intensity in 1 sample, the network structure was similar across the 2 samples.
Discussion:
Overall, our results show that psychological factors related to disability have intricate interrelations, highlighting the complexity of chronic pain and the need to study its many components in relation to each other. The consistency across the 2 samples provides encouraging evidence that the results reflect a stable pattern within this complex system.
Music therapy with adults in the subacute phase after stroke
A study protocol
Human cues in eHealth to promote lifestyle change
An experimental field study to examine adherence to self-help interventions
Can Pharmacological Conditioning as an Add-On Treatment Optimize Standard Pharmacological Treatment in Patients with Recent-Onset Rheumatoid Arthritis?
A Proof-of-Principle Randomized Clinical Trial
Erasing stigmas through storytelling
Why interactive storytelling environments could reduce health-related stigmas