Expected Side Effect Research Articles

8690 Severe Hypocalcemia Following Treatment with Venetoclax for AML

Abstract Disclosure: K. Ruddiman: None. C. Price: None. Background: Venetoclax is a chemotherapeutic agent which has known side effects of tumor lysis syndrome, but few reports of isolated hypocalcemia. Clinical case: A 73 year old male with medical history pertinent for myeloproliferative and myelodysplastic disease was admitted for evaluation of failure to thrive. Workup revealed progression to acute myeloid leukemia. Following treatment with decitabine 34mg/day for 5 doses and initiation of venetoclax 100mg daily, he developed progressive, severe, symptomatic hypocalcemia with positive Trousseau and Chvostek sign. The patient was normocalcemic prior to admission with serum calcium ranging between 8.6-9.7mg/dL. Corrected calcium at admission was 8.8mg/dL. Serum calcium decreased steadily following venetoclax, requiring repletion with 3 doses of calcium chloride and gluconate 1gm IV and initiation of oral calcium carbonate 1900mg TID. At its nadir, corrected calcium was 6.1mg/dL on day 19 of treatment with venetoclax despite oral and IV repletion. Further workup showed undetectable 25 hydroxy vitamin D, PTH 62pg/mL, normal range uric acid, low phosphorus (lowest 2.2mg/dL), mild hypokalemia (lowest 3.2mg/dL), and mild hypomagnesemia of 1.8mg/dL. GFR was >90mL/min. Hypocalcemia improved after 3 infusions of calcium gluconate 10gm IV in 1 L normal saline to 7.2mg/dL. Oral repletion with calcium carbonate was transitioned to calcium citrate due to concomitant PPI use. PO calcium citrate titrated to 2850 mg TID to target corrected calcium 7.5 - 8.5 and limit further need for diuresis following calcium gluconate infusions. Ergocalciferol 50,000 IU was given thrice weekly in addition to daily cholecalciferol 5,000 IU with improvement in 25 hydroxy vitamin D to 17ng/mL. This patient was suspected to have multifactorial etiology for hypocalcemia, secondary to undetectable 25 hydroxy vitamin D as well as diuresis with furosemide during the admission, but the most strongly attributed factor was initiation of venetoclax prior to development of progressive hypocalcemia. FDA prescribing information reports hypocalcemia as a side effect of venetoclax when used in treatment for CML, but in phase 2 and 3 studies of venetoclax used alone and in combination with low dose cytarabine to treat AML, no significant episodes of hypocalcemia were reported. Tumor lysis syndrome (TLS) is a known adverse effect of venetoclax in which hypocalcemia is an expected feature, however, this patient did not have laboratory to support this diagnosis. His other electrolyte deficiencies were mild and transient. Conclusion: While electrolyte abnormalities associated with TLS are an expected side effect of venetoclax, isolated severe hypocalcemia is a rarely reported side effect. Calcium should be closely monitored during treatment. Presentation: 6/1/2024

Omalizumab for Treatment of Anti-GD2 Antibody-related Urticaria.

Outcomes for high-risk neuroblastoma have improved with the addition of antidisialoganglioside (GD2) antibody-mediated immunotherapy to multimodality therapy. Urticaria is an expected side effect of anti-GD2 immunotherapy. Rarely, despite maximal use of antihistamines and H2 receptor antagonists, refractory urticaria can result in impaired quality of life, and delays or discontinuation of immunotherapy. The anti-IgE monoclonal antibody, omalizumab, is approved for the treatment of asthma and chronic spontaneous urticaria. We successfully managed grade 3, naxitamab-related urticaria refractory to standard management in 2 patients using omalizumab, allowing for continued anti-GD2 immunotherapy. Omalizumab did not impact antitumor activity or immunogenicity of naxitamab.

Identifying the psychological effects of nocebo education: results from two pre-registered experiments

Providing treatment side effect information to patients increases the risk of harm due to the nocebo effect. Nocebo education, in which patients learn about nocebo effects, is a novel strategy that can be used across a variety of situations and individuals to decrease unpleasant treatment side effects. It is currently unclear which psychological changes are induced by nocebo education, which is information required to maximize this intervention. Two pre-registered studies investigated the effects of nocebo education on side effect expectations, side effect control beliefs, feelings toward treatments, intentions to avoid or seek side effect information, and perceptions of treatment efficacy. In Study 1 (N = 220), adult participants either watched or did not watch a nocebo education intervention video prior to reading vignettes about receiving a surgical treatment for pain and a medication for pain. Study 2 (N = 252) was similar to Study 1, with the inclusion of a health behavior video control group and participants only reading about a medication treatment for pain. In both experiments, nocebo education reduced global side effect expectations and increased side effect self-efficacy beliefs. Nocebo education also increased intentions to avoid side effect information and decreased intentions to seek more side effect information. Evidence was inconclusive on whether nocebo education changes affective associations with the treatments. The findings demonstrate that nocebo education has a multi-faceted influence with the potential to change patient behavior. The results can be used to improve the management of adverse treatment side effects.

Pancytopenie en drug fever bij olanzapine

Olanzapine-induced pancytopenia and drug fever Olanzapine is a frequently used antipsychotic. Despite the structural similarity, olanzapine is considered a safer alternative for clozapine in terms of side effects. Hematological suppression, particularly neutropenia, is generally not associated with olanzapine. Furthermore, fever in the absence of a malignant neuroleptic syndrome is not an expected side effect of olanzapine. This case reports the occurrence of olanzapine-induced pancytopenia and fever in a 74-year-old woman with acute psychosis. Both side effects developed a few days after starting olanzapine and resolved after its discontinuation. Extensive investigations did not reveal any satisfactory alternative explanation for both phenomena. This article describes other cases with similar findings and discusses the possible pathogenesis. This case, in addition to other case reports, suggests that olanzapine can also lead to hematological suppression. Whether hematological monitoring, as with clozapine, is required, needs further investigation. Furthermore, this case illustrates that fever can occur with olanzapine in the absence of a malignant neuroleptic syndrome. Increased vigilance for both side effects is therefore indicated.

Side-effect expectations are associated with disability, physical fitness, and somatic symptoms 3 months after post-COVID neurological inpatient rehabilitation

IntroductionThe COVID-19 pandemic, caused by SARS-CoV-2, has led to long-term health issues known as post-COVID-19 condition, including fatigue and cognitive disruptions. Despite its recognition as a public health concern, the efficacy of therapeutic interventions, especially in neurological rehabilitation, remains unclear. This study examines how treatment expectations are associated with psychological and physical outcomes in post-COVID-19 condition neurological rehabilitation. MethodsIn an observational cohort study 61 patients with confirmed post-COVID-19 condition were included. Baseline (T0) data on treatment and side effect expectations were collected, before participants underwent a 4–6 week multidisciplinary rehabilitation program. Primary outcome was illness-related disability (Pain Disability Index). Secondary outcomes included depressive symptoms (PHQ-9), anxiety levels (GAD-7), functional status (PCFS), fatigue (CFS), and physical fitness (6MWT). Regression models analyzed the associations of baseline expectations with outcomes at the end of rehabilitation (T1) and three months post-rehabilitation (T2). ResultsAfter adjusting for multiple testing, higher baseline side-effect expectations were associated with greater illness-related disability (β = 0.42, p = 0.007), reduced physical fitness (β = − 0.24, p = 0.04), and more somatic symptoms (β = 0.33, p = 0.006) at follow-up (T2). Positive treatment expectations were associated with poorer functional status (β = 0.35, p = 0.011) at T2. ConclusionThis study highlights the associations of side-effect expectations with post-COVID-19 condition rehabilitation outcomes. Higher side-effect expectations were associated to poorer outcomes, indicating a nocebo effect. Surprisingly, positive expectations were linked to worse outcomes, possibly due to unrealistic optimism. Managing patient expectations realistically and addressing side-effect concerns seems crucial for optimizing rehabilitation outcomes.

Statin intolerance and the drucebo effect.

Hypercholesterolemia is a well-described risk factor for atherosclerotic cardiovascular disease (ASCVD). Statins remain the cornerstone of therapy. Statin intolerance (SI) particularly statin associated muscle symptoms (SAMS) and inappropriate stopping of treatment is associated with increased cardiovascular risk. A significant proportion of reported SAMS relates to expectation of side effects and can be termed the 'negative drucebo effect'. Patients should be educated about SI, the negative drucebo effect, in addition to the benefits of adherence to the therapy when first prescribed a statin. The aim of this commentary is to discuss the issue of statin intolerance, the negative drucebo effect and to suggest some interventions that may be used to address this issue.

NURS-20. A PATIENT AND FAMILY EDUCATION PROJECT: COMPREHENSIVE RESOURCE FOR MEK INHIBITOR-INDUCED PARONYCHIA

Abstract BACKGROUND Targeted therapies for pediatric tumors of the central nervous system have recently brought promising results as well as new challenges in the clinical management of these patients. FDA approval of MEK inhibitors has prompted a significant increase in use of these agents in pediatric neuro-oncology patients. MEK inhibitors are commonly used for treatment of pediatric low and high-grade gliomas, as well being a proven treatment for plexiform neurofibromas. Cutaneous reactions to targeted therapy occur frequently, with paronychia arising in more than half the patients. METHODS Despite providing a robust MEK inhibitor skin care in-service at the start of treatment, the multidisciplinary neuro-oncology team identified a need for specific paronychia education for patients undergoing therapy with MEK inhibitors. The education content was developed following a thorough literature review of MEK inhibitors and associated side effects. Evidence-based information was selected to create a clear, concise, one-page educational resource. RESULTS The educational flyer addressed five key educational objectives including defining and reviewing paronychia as an expected side effect of MEK inhibitor therapy, discussing strategies for prevention and management of paronychia, and identifying when to contact a healthcare provider for paronychia support. Content included written and pictorial definitions to aid in recognition of paronychia, bulleted list and visual guide for preventive nail maintenance, recommendations and instructions for over-the-counter management strategies, review of therapies that may be prescribed, and specific guidelines on when to seek prompt medical attention. This flyer served as a valuable educational tool, equipping individuals undergoing MEK inhibitor therapy with knowledge about paronychia, prevention, and effective management. CONCLUSION MEK inhibitor-induced paronychia is an undesirable side effect that can impact adherence to treatment. By empowering patients and families with this educational resource, healthcare providers may enhance patient engagement, promote adherence to treatment, and optimize quality of life.

Media coverage of COVID-19 vaccination-associated cerebral venous sinus thrombosis was followed by a surge in emergency presentations due to headache – observations from a university hospital in Germany

Nocebo effects describe all negative outcomes for well-being brought about by negative health-related expectations. Media coverage of drug side effects can fuel nocebo effects and lead to increased symptom reports. This retrospective observational analysis of emergency reports at the neurological emergency room at University Hospital Essen, Germany, examines whether media communication about a cumulation of very rare cases of cerebral venous sinus thrombosis (CVST) after COVID-19 vaccination with the AstraZeneca compound (ChAdOx-1 nCoV-19) was followed by an increase in weekly presentation rates of patients with the main complaint of headache, a symptom commonly occurring as a vaccination reaction but also communicated as a warning symptom for CVST. The rate of headache presentations increased by 171.7% during the five weeks after the first announcement of CVSTs in Germany on 11 March 2021, compared to the five weeks immediately prior. Furthermore, more young women sought consultation for headache, reflecting the communicated at-risk profile for CVST. The increased rate of headache presenters contributed to a 32.1% rise in total neurological emergency cases, causing an increased strain on the emergency facility after the side effect risk was publicized. We discuss a causal role of negative side effect expectations after vaccination with AstraZeneca as a driver for this increase. While transparent communication about benefits and potential side effects is crucial for vaccination acceptance, increased vigilance toward nocebo effects in health-related media communication is needed due to its potential harm to the individual and society, especially when emergency medical resources are stretched thin.

Abstract ED08-02: Next generation therapeutics in hormone positive breast cancer: balancing efficacy and tolerability

Abstract The past several years have brought a wealth of new and emerging novel agents for the management of both early and advanced hormone repcetor positive breast cancer, including inhibitors of PIK3CA, mTOR, AKT, CDK4/6, PARP, as well as oral SERDs. These agents have significantly improved survival outcomes for many patients, but progress may come at the cost of specific and sometimes challeging side effects, whcih may threaten the ability to keep a patient on a therapy that is providing benefit. We will review a spectrum of agents, the expected side effect profiles, and strategies to mitigate toxicity and maximize therapeutic index. Citation Format: E. Mayer. Next generation therapeutics in hormone positive breast cancer: balancing efficacy and tolerability [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr ED08-02.

Measuring the Influence of Side Effect Expectations, Beliefs, and Incident Side Effects on the Risk for Drug Discontinuation Among Individuals Starting New Medications, a Cross-sectional Study.

To measure the impact of beliefs, expectations, side effects, and their combined effects on the risk for medication nonpersistence. Using a cross-sectional design, individuals from Saskatchewan, Canada who started a new antihypertensive, cholesterol-lowering, or antihyperglycemic medication were surveyed about risk factors for nonpersistence including: (a) beliefs measured by a composite score of three questions asking about the threat of the condition, importance of the drug, and harm of the drug; (b) incident side effects attributed to treatment; and (c) expectations for side effects before starting treatment. Descriptive statistics and logistic regression models were used to quantify the influence of these risk factors on the outcome of nonpersistence. Odds ratios (ORs) and 95% confidence intervals (CIs) were estimated. Among 3,029 respondents, 5.8% (n=177) reported nonpersistence within four months after starting the new drug. After adjustment for numerous covariates representing sociodemographics, health-care providers, medication experiences and beliefs, both negative beliefs (OR: 7.26, 95%CI: 4.98-10.59) and incident side effects (OR: 8.00, 95%CI: 5.49-11.68) were associated with the highest odds of nonpersistence with no evidence of interaction. In contrast, expectations for side effects before starting treatment exhibited an important interaction with incident side effects following treatment initiation. Among respondents with incident side effects (n=741, 24.5%), the risk for early nonpersistence was 11.5% if they indicated an expectation for side effects before starting the medication compared to 23.6% if they did not (adjusted OR: 0.38, 95%CI: 0.25-0.60). Expectations for side effects may be a previously unrecognized but important marker of the probability to persist with treatment. A high percentage of new medication users appeared unprepared for the possibility of side effects from their new medication making them less resilient if side effects occur.

Persistent Gynecomastia due to Short-term Low-dose Finasteride for Androgenetic Alopecia.

We report a case of persistent gynecomastia in a healthy 20-year-old man after 1 month of low-dose finasteride. Finasteride was discontinued after 2 months, and gynecomastia was unchanged 5 months after drug withdrawal. The gynecomastia regressed but did not resolve after 6 months of treatment with raloxifene, a selective estrogen receptor modulator. One year later, bilateral mammoplasty was performed to remove the remaining breast tissue. Finasteride, a 5-alpha-reductase inhibitor, is widely used for the treatment of androgenetic alopecia. Gynecomastia is an expected side effect of this therapy given its mechanism of action. However, only 8 cases of gynecomastia have been reported with low-dose (1 mg daily) finasteride treatment since its approval for androgenetic alopecia in 1997. This raises the concern that gynecomastia resulting from low-dose finasteride is significantly underreported, causing inadequately informed patients. Further, because of the risk of gynecomastia, it is important for prescribing physicians to counsel patients regarding this complication and to consider early intervention when finasteride-induced gynecomastia first arises to prevent fibrosis and thus irreversible gynecomastia.

Can side effect expectations be assessed implicitly? A comparison of explicit and implicit expectations of vaccination side effects

ObjectiveTreatment 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. MethodsN = 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). ResultsWhereas 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). ConclusionExpectations 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.

The influence of psychological traits and prior experience on treatment expectations

BackgroundPlacebo and nocebo responses are modulated by the treatment expectations of participants and patients. However, interindividual differences predicting treatment expectations and placebo responses are unclear. In this large-scale pooled analysis, we aim to investigate the influence of psychological traits and prior experiences on treatment expectations. MethodsThis paper analyses data from six different placebo studies (total n = 748). In all studies, participants' sociodemographic information, treatment expectations and prior treatment experiences and traits relating to stress, somatization, depression and anxiety, the Big Five and behavioral inhibition and approach tendencies were assessed using the same established questionnaires. Correlation coefficients and structural equation models were calculated to investigate the relationship between trait variables and expectations. ResultsWe found small positive correlations between side effect expectations and improvement expectations (r = 0.187), perceived stress (r = 0.154), somatization (r = 0.115), agitation (r = 0.108), anhedonia (r = 0.118), and dysthymia (r = 0.118). In the structural equation model previous experiences emerged as the strongest predictors of improvement (β = 0.32, p = .005), worsening (β = −0.24, p = .005) and side effect expectations (β = 0.47, p = .005). Traits related to positive affect (β = − 0.09; p = .007) and negative affect (β = 0.04; p = .014) were associated with side effect expectations. DiscussionThis study is the first large analysis to investigate the relationship between traits, prior experiences and treatment expectations. Exploratory analyses indicate that experiences of symptom improvement are associated with improvement and worsening expectations, while previous negative experiences are only related to side effect expectations. Additionally, a proneness to experience negative affect may be a predictor for side effect expectation and thus mediate the occurrence of nocebo responses.

Is Injectable Platelet-Rich Fibrin Really Effective in Reducing Expected Side Effects of Removing Impacted Third Molar Surgery?

Common side effects of third molar (M3) operations including pain, edema, and trismus have an adverse effect on patient quality of life. Injectable platelet-rich fibrin (i-PRF) may ameliorate some of the side effects of the operation. The primary purpose of this study is to measure and compare differences in pain, swelling, trismus, and quality of life between i-PRF side and a control side of subjects undergoing M3 removal. This study is a single-center, split-mouth, randomized prospective clinical trial conducted at Ordu University Faculty of Dentistry. Patients who presented between March and August 2022 for the extraction of impacted third molars due to various reasons were included in the study. The exclusion criteria were local conditions and systematic comorbidities. Additionally, patients with differences that could cause bias between the sides were excluded from the study. The predictor variable is treatment i-PRF or control. The outcome variables of interest are the pain level and analgesic consumption values on the Visual Analog Scale, the distance between determined reference points, maximum mouth opening, and the Postoperative Symptom Severity scale data. A Postoperative Symptom Severity scale was created using questions commonly employed in the clinical evaluation of patients following the extraction of third molars. This scale was further divided into subscales corresponding to the 7 primary adverse effects identified in a prior study. Covariate variables, sex, age, and operation times. The normality of the distribution of the study data was assessed using the Kolmogorov-Smirnov test. Depending on whether the data exhibited a normal distribution or not, the data were analyzed using either the paired t-test or the Wilcoxon test. A P value < .05 was considered statistically significant. The study included 35 patients with a mean age of 19.97±2.07years. The i-PRF side significant success in postoperative edema measurements. There was a statistically significant difference observed between the control side and the i-PRF side on the second day (control: 9.74±0.57mm, i-PRF: 9.46±0.51mm) and seventh day (control: 9.33±0.59mm, i-PRF: 9.12±0.50mm) in lateral canthus-angulus measurements (P: .01 and P: .04, respectively). Additionally, on the second day, there was a statistically significant difference in tragus-commisura measurements (control: 11.53±0.62mm, i-PRF: 11.31±0.58mm) with a P value of .02. There was no significant difference observed between the sides in terms of postoperative pain (P>.05). However, analgesic consumption in the i-PRF side was significantly lower at the sixth hour (control: 1.8±0.58 dose, i-PRF: 1.14±0.35 dose), 24th hour (control: 1.77±0.54 dose, i-PRF: 1.14±0.35 dose), and second day (control: 1.8±0.47 dose, i-PRF: 1.4±0.73 dose) postoperatively (P: .000, P: .000, and P: .012). Mouth opening was significantly lower in the i-PRF side on the second day (control: 27.88±6.48mm, i-PRF: 25.51±5.56mm) (P: .025). However, i-PRF had no significant effect on postoperative quality of life (P>.05). According to the study results, i-PRF had a limited effect on the management of postoperative pain, but i-PRF was effective in reducing postoperative edema. Further studies with larger patient sides are now needed to yield more detailed findings on the subject.

Influence of side effect information on patient willingness to take medication: consequences for informed consent and medication adherence.

Medication side effect information can create negative patient expectations of side effects, but such information is considered crucial to informed consent. The current study investigated the effect of informing participants of different numbers of medication side effects. Willingness to take the medication was highest for those informed of one or four compared with none or 26 side effects, and memory of side effects was also more accurate. Findings suggest that informing patients of some, but not several, side effects may optimise both medication adherence and accuracy of informed consent.

The effect of nocebo explanation and empathy on side-effect expectations of medication use following a fictional GP consultation

ABSTRACT The simple act of informing patients about side-effects increases the likelihood they will experience them (i.e. the nocebo effect). Explaining this psychological phenomenon could help to reduce side-effect experience, however, it is yet to be explored if this can be applied to clinical settings where new medication is prescribed. In addition, the degree to which a health-care provider empathetically communicates this to patients may have an impact. To investigate this, we carried out 2 × 2 factorial trial to assess the effect of nocebo explanation and empathy (plus their interaction) on side-effect expectations following a fictional GP consultation prescribing a new medication. Overall, 208 participants were randomised to watch one of the four fictive GP consultations and play the role of the patient. In all videos, participants received information about the reason for the consultation, the recommendation of a new fictive medicine, how to take it, benefits and side-effects. The videos differed in whether the GP provided an explanation of the nocebo effect (yes/no) and whether they communicated in an empathetic style (yes/no). After watching the video, participants were asked about their side-effect expectations and rated the quality of the GP’s communication. Two-way ANOVAs revealed no main effect of nocebo explanation on expectation of side-effects warned or not warned about in the consultation. However, there was a main effect of empathy, with participants watching the empathetic consultations having significantly lower expectations of non-warned-about side-effects. There was no significant interaction. Findings suggest that explaining the nocebo effect and GP empathy did little to allay expectations of side-effects that were specifically mentioned in the consultation. However, GP empathy had an effect by helping to reduce additional side-effect expectations participants still had. Future work should extend these findings to real GP consultations where the full dimensions of empathy can be explored.

What Is the Benefit of Adding Placebo Side-Effect Information to Positively Framed Patient Leaflets?

Abstract: Background: Positively framing side-effect risk in patient information leaflets (PILs) can reduce side-effect expectations and resulting nocebo effects (nonspecific medication side effects unrelated to the drug’s pharmacological action). There is scope to educate patients about nocebo effects in PILs to minimize their occurrence further. Aims: To investigate if incorporating information on placebo-reported side effects reduces side-effect expectations compared to a positively framed-only or standard PIL. Methods: Participants ( N = 443) completed an online study and were randomized to read one of three PILs for a hypothetical antibiotic: standard PIL ( n = 140), positively framed PIL ( n = 151), or positively framed PIL with placebo side-effect information ( n = 152). Participants’ side-effect expectations, absolute risk perceptions, and intended adherence were recorded. Results: The standard PIL resulted in significantly higher side-effect expectations compared to the positively framed + placebo side-effect information PIL. Including the placebo side-effect results had no effect on side-effect expectations compared to the positive framing only PIL, however, there was a significant interaction between health literacy and PIL condition on side-effect expectations. Both positively framed PILs produced more accurate risk estimates for the more common side effects. There was no difference in intended adherence between the three PILs. Limitations: Our findings are limited by the highly educated sample and hypothetical context. Conclusions: There was no benefit of adding placebo side-effect information, however alternative ways of explaining nocebo effects in PILs should be explored utilizing clinical contexts and samples with a wider range of participant ages, and health literacy.

Social communication pathways to COVID-19 vaccine side-effect expectations and experience

ObjectiveNegative beliefs about medication and vaccine side-effects can spread rapidly through social communication. This has been recently documented with the potential side-effects from the COVID-19 vaccines. We tested if pre-vaccination social communications about side-effects from personal acquaintances, news reports, and social media predict post-vaccination side-effect experiences. Further, as previous research suggests that side-effects can be exacerbated by negative expectations, we assessed if personal expectations mediate the relationships between social communication and side-effect experience. MethodIn a prospective longitudinal survey (N = 551), COVID-19 vaccine side-effect information from three sources—social media posts, news reports, and first-hand accounts from personal acquaintances—as well as side-effect expectations, were self-reported pre-vaccination. Vaccination side-effect experience was assessed post-vaccination. ResultsIn multivariate regression analyses, the number of pre-vaccination social media post views (β = 0.17) and impressions of severity conveyed from personal acquaintances (β = 0.42) significantly predicted an increase in pre-vaccination side-effect expectations, and the same variables (βs = 0.11, 0.14, respectively) predicted post-vaccination side-effect experiences. Moreover, pre-vaccination side-effect expectations mediated the relationship between both sources of social communication and experienced side-effects from a COVID-19 vaccination. ConclusionsThis study identifies links between personal acquaintance and social media communications and vaccine side-effect experiences and provides evidence that pre-vaccination expectations account for these relationships. The results suggest that modifying side-effect expectations through these channels may change the side-effects following a COVID-19 vaccination as well as other publicly discussed vaccinations and medications.

Optimized Informed Consent for Psychotherapy: Protocol for a Randomized Controlled Trial.

BackgroundInformed consent is a legal and ethical prerequisite for psychotherapy. However, in clinical practice, consistent strategies to obtain informed consent are scarce. Inconsistencies exist regarding the overall validity of informed consent for psychotherapy as well as the disclosure of potential mechanisms and negative effects, the latter posing a moral dilemma between patient autonomy and nonmaleficence.ObjectiveThis protocol describes a randomized controlled web-based trial aiming to investigate the efficacy of a one-session optimized informed consent consultation.MethodsThe optimized informed consent consultation was developed to provide information on the setting, efficacy, mechanisms, and negative effects via expectation management and shared decision-making techniques. A total of 122 participants with an indication for psychotherapy will be recruited. Participants will take part in a baseline assessment, including a structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-fifth edition (DSM-5) disorders. Eligible participants will be randomly assigned either to a control group receiving an information brochure about psychotherapy as treatment as usual (n=61) or to an intervention group receiving treatment as usual and the optimized informed consent consultation (n=61). Potential treatment effects will be measured after the treatment via interview and patient self-report and at 2 weeks and 3 months follow-up via web-based questionnaires. Treatment expectation is the primary outcome. Secondary outcomes include the capacity to consent, decisional conflict, autonomous treatment motivation, adherence intention, and side-effect expectations.ResultsThis trial received a positive ethics vote by the local ethics committee of the Center for Psychosocial Medicine, University-Medical Center Hamburg-Eppendorf, Hamburg, Germany on April 1, 2021, and was prospectively registered on June 17, 2021. The first participant was enrolled in the study on August 5, 2021. We expect to complete data collection in December 2022. After data analysis within the first quarter of 2023, the results will be submitted for publication in peer-reviewed journals in summer 2023.ConclusionsIf effective, the optimized informed consent consultation might not only constitute an innovative clinical tool to meet the ethical and legal obligations of informed consent but also strengthen the contributing factors of psychotherapy outcome, while minimizing nocebo effects and fostering shared decision-making.Trial RegistrationPsychArchives; http://dx.doi.org/10.23668/psycharchives.4929International Registered Report Identifier (IRRID)DERR1-10.2196/39843

Possible alleviation of symptoms and side effects through clinicians’ nocebo information and empathy in an experimental video vignette study

To alleviate anti-cancer treatment burden in advanced breast cancer, patient-clinician communication strategies based on nocebo-effect mechanisms are promising. We assessed distinct/combined effects on psychological outcomes (e.g. anxiety; main outcome) and side-effect expectations of (1) nocebo information about the (non)pharmacological origin of side effects, and (2) clinician-expressed empathy through reassurance of continuing support. Furthermore, we explored whether information and empathy effects on side-effect expectations were mediated by decreased anxiety. In a two-by-two experimental video-vignette design, 160 cancer patients/survivors and healthy women watched one of four videos differing in level of nocebo information (±) and empathy (±). Regression and mediation analysis were used to determine effects of information/empathy and explore anxiety’s mediating role. Anxiety was not influenced by empathy or information (Stai-state: p = 0.281; p = 0.410, VAS p = 0.387; p = 0.838). Information improved (specific) side-effect coping expectations (p < 0.01). Empathy improved side-effect intensity expectations (p < 0.01 = specific; p < 0.05 = non-specific/partial) and specific side-effect probability expectations (p < 0.01), and increased satisfaction, trust, and self-efficacy (p < 0.001). No mediating effects were found of anxiety on expectations. Mainly empathy, but also nocebo information improved psychological outcomes and—mainly specific—side-effect expectations. Exploring the power of these communication elements in clinical practice is essential to diminish the anti-cancer treatment burden in advanced breast cancer.