[Placebo procedures in the operating room: necessary or an unnecessary risk for the patient?] / Placeboprocedures in de operatiekamer.

Sham surgeries, surgical procedures without actually carrying out the intended surgical intervention, are rarely used in research concerning a new surgical or invasive technique. The conflicting needs of minimizing operational risks and maximizing simulation present challenges in designing placebo-controlled surgical trials. It is important to thoroughly consider ethical considerations in the design of studies involving sham surgeries, including the importance of a transparent research design, objective reporting of results, challenges related to the informed consent procedure, and the inherent risks associated with surgical procedures. Furthermore, there exists a societal need to offer patients the most cost-effective intervention. Responsible sham surgeries are therefore crucial for understanding the potential and cost-effectiveness of surgical interventions compared to less invasive placebo conditions. Clinically high-quality studies involving placebo-based interventions can provide clarity regarding the balance between doing good and avoiding harm through surgical interventions.

Nocebo hyperalgesia and other expectancy-related factors in daily fibromyalgia pain: Combining experimental and electronic diary methods.

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.

Evaluation of Quality of Life and Treatment Satisfaction in Newly Diagnosed Cutaneous T-Cell Lymphoma Patients.

BACKGROUND: Little is known about the impact of MF on quality of life (QoL) in newly diagnosed patients. OBJECTIVES: To describe the impact of the MF diagnosis on QoL, patient expectations, and treatment satisfaction over the first 6 months after diagnosis. METHODS: Outcomes of this prospective cohort study of newly diagnosed MF patients conducted between 2020 and 2022 at the Leiden University Medical Center included the Skindex-29, RAND-12 Health Survey, degree of itch, pain, and fatigue (Visual Analogue Scale (VAS)), patient expectations, and Client Satisfaction Questionnaire-8 (CSQ-8), measured at baseline and after six months. RESULTS: A total of 28 patients with MF were included. At baseline, 66% (n = 18) "strongly-totally" expected positive effects of the treatment. At the time of diagnosis, 28% of the patients (n = 8) were moderately to severely affected. There was no statistical change in the Skindex-29 score sum score (20 [10-34] vs. 20 [9-36]; p = 0.81) or in the other three subdomains, the RAND-12 scores, and the VAS itch, pain, and fatigue over time. Treatment satisfaction was high overall. CONCLUSION: Despite that the newly diagnosed MF patients anticipate a positive treatment effect, few improvements in QoL and symptom reduction were found. These data can be used for adequate expectation management and provide a rationale for further evaluation of treatment regimens in these patients.

Unveiling the hidden struggles: Exploring the profound impact of advanced stage cutaneous T-cell lymphoma on quality of life.

Erythrodermic mycosis fungoides and Sézary syndrome are chronic, relapsing-remitting diseases that greatly impacts patients' quality of life (QoL). Mogamulizumab-kpkc (Mogamulizumab) is a novel therapeutic agent for cutaneous T-cell lymphomas with a notable impact on progression-free survival. Qualitative assessment methods allow a broader exploration and greater insight in individual patient experience than quantitative studies. However, there is limited data on the impact of mogamulizumab on health-related QoL. To investigate the impact of erythrodermic cutaneous T-cell lymphoma (E-CTCL) on QoL and the effect of mogamulizumab on the QoL. Semi-structured interview were conducted with seven patients with E-CTCL that were receiving mogamulizumab treatment. Five major themes arose: Diagnosis and the diagnostic delay and uncertainty experienced by participants; Physical functioning due to the high symptom burden; Psychological and social functioning considering the significant impact on daily life; Treatment and the effect of mogamulizumab; and Support by family, friends and health professionals. Mogamulizumab therapy resulted in a significant decrease of symptoms. The small sample size should also be taken into account although data saturation was reached. This study gives a broad insight into the large impact of E-CTCL and the major consequences on the physical functioning as well as on the emotional/psychological and social well-being. Mogamulizumab appears to have a positive effect on symptoms.

Harmful communication behaviors in cancer care: A systematic review of patients and family caregivers perspectives.

OBJECTIVE: Issues regarding clinician communication remain an important source of complaints within healthcare. This systematic review aims to determine cancer patients' and their family caregivers' views on which clinicians' communication behaviors can harm (i.e. eliciting negative feelings/consequences for patients/family caregivers). METHODS: We searched for all types of peer-reviewed studies that determined adult (≥18 years) cancer patients' and/or family caregivers' perspectives on which clinicians' communication behaviors can harm in several databases (PubMed, Embase, Web of Science, Cochrane Library, Emcare, PsycINFO and Academic Search Premier), supplemented by expert-consultation. Studies were screened using the Artificial intelligence screening tool of ASReview and data was analyzed using Thematic Analysis. To assess the quality of the studies the Qualsyst critical appraisal tool was used. RESULTS: A total of 47 studies were included. Four main themes of harmful communication behaviors were identified: (1) Lack of tailored information provision (e.g. giving too little or too much/specific information) (2) Lack of tailored decision making (ranging from; patient exclusion, to the patients' responsibility, and/or haste) (3) Lack of feeling seen and heard (seen as a disease, not as a human being; not listened to concerns and emotions) (4) Lack of feeling held and remembered (forgotten agreements; lack of care continuity). CONCLUSIONS: Our results reveal an overview of patients' and family caregivers' perspectives on which clinicians' communication behaviors can harm. Harm could be prevented when information and decision involvement are tailored and patients' and family caregivers' needs to feel seen, heard, held and remembered are met.

Psychological Distress and Self-Management in CKD: A Cross-Sectional Study.

Rationale & Objective: Patients with chronic kidney disease (CKD) not receiving dialysis, including kidney transplant recipients, often experience difficulties regarding self-management. An important barrier for adherence to self-management recommendations may be the presence of psychological distress, consisting of depressive and anxiety symptoms. We investigated relationships between psychological distress and adherence to self-management recommendations. Study Design: Cross-sectional online questionnaire data as part of the E-GOAL study. Setting & Participants: Patients with CKD (estimated glomerular filtration rate, 20-89 mL/min/1.73 m2) were recruited from April 2018 to October 2020 at 4 hospitals in The Netherlands and completed online screening questionnaires. Exposures: Psychological distress, depressive symptoms, and anxiety symptoms. Outcomes: Dietary adherence, physical activity, medication adherence, smoking, body mass index, and a CKD self-management index (ie, the sum of 5 binary indicators of nonadherence to the recommended self-management factors). Analytical Approach: Adjusted multivariable regression and ordinal logistic regression analyses. Results: In our sample (N = 460), 27.2% of patients reported psychological distress, and 69.8% were nonadherent to 1 or more recommendations. Higher psychological distress was significantly associated with poorer dietary adherence (ßadj, -0.13; 95% CI, -0.23 to -0.04), less physical activity (ßadj, -0.13; 95% CI, -0.22 to -0.03), and lower medication adherence (ßadj, -0.15; 95% CI, -0.24 to -0.05), but not with smoking and body mass index. Findings were similar for depressive symptoms, whereas anxiety was only associated with poorer dietary and medication adherence. Every 1-point higher psychological distress was also associated with a higher likelihood of being nonadherent to an accumulating number of different recommendations (adjusted OR, 1.04; 95% CI, 1.02-1.07). Limitations: Cross-sectional design, possible residual confounding, and self-report. Conclusions: Many people with CKD experience psychological distress, of whom most have difficulties self-managing their CKD. Given the relationship between psychological distress and adherence to CKD self-management recommendations, behavioral interventions are needed to identify and treat psychological distress as a potential barrier to CKD self-management. Plain-Language Summary: This online questionnaire study investigated relationships between psychological distress and self-management among 460 people with chronic kidney disease. Over a quarter of them reported mild-to-severe psychological distress. Alarmingly, 4 out of 5 patients with psychological distress were also nonadherent to 1 or more self-management recommendations, and higher levels of psychological distress were associated with poorer dietary and medication adherence and lower physical activity. Moreover, patients who suffered from moderate-to-severe distress were relatively more often nonadherent to 3 or more recommendations compared with patients with no or mild distress symptoms. So, it seems that psychological distress can be a barrier for self-management. To support patients in managing chronic kidney disease, researchers and health professionals should not overlook patients' mental health.

Nocebo Hyperalgesia in Patients With Fibromyalgia and Healthy Controls: An Experimental Investigation of Conditioning and Extinction Processes at Baseline and 1-Month Follow-up.

Nocebo effects are adverse treatment outcomes that are not ascribed to active treatment components. Potentially, their magnitude might be higher in patients with chronic pain compared to healthy controls since patients likely experience treatment failure more frequently. The current study investigated group differences in the induction and extinction of nocebo effects on pressure pain at baseline (N = 69) and 1-month follow-up (N = 56) in female patients with fibromyalgia and matched healthy controls. Nocebo effects were first experimentally induced via classical conditioning combined with instructions on the pain-increasing function of a sham transcutaneous electrical nerve stimulation device, then decreased via extinction. One month later, the same procedures were repeated to explore their stability. Results suggest that nocebo effects were induced in the healthy control group during baseline and follow-up. In the patient group, nocebo effects were only induced during follow-up, without clear group differences. Extinction was only observed during baseline in the healthy control group. Further comparisons of nocebo effects and extinction indicated no significant changes across sessions, possibly suggesting their overall magnitudes were stable over time and across groups. In conclusion, contrary to our expectations, patients with fibromyalgia did not have stronger nocebo hyperalgesia; instead, they might be less responsive to nocebo manipulations than healthy controls. PERSPECTIVE: The current study is the first to investigate group differences in experimentally manipulated nocebo hyperalgesia between chronic pain and healthy populations at baseline and 1-month follow-up. Since nocebo effects are common in clinical settings, their investigation in different populations is essential to explain and minimize their adverse effects during treatment.

Hydrocortisone to reduce dexamethasone-induced neurobehavioral side-effects in children with acute lymphoblastic leukaemia-results of a double-blind, randomised controlled trial with cross-over design.

BACKGROUND: Dexamethasone is a cornerstone of paediatric acute lymphoblastic leukaemia (ALL) treatment, although it can induce serious side-effects. Our previous study suggests that children who suffer most from neurobehavioural side-effects might benefit from physiological hydrocortisone in addition to dexamethasone treatment. This study aimed to validate this finding. METHODS: Our phase three, double-blind, randomised controlled trial with cross-over design included ALL patients (3-18 years) during medium-risk maintenance therapy in a national tertiary hospital between 17th May 2018 and 5th August 2020. A baseline measurement before and after a 5-day dexamethasone course was performed, whereafter 52 patients with clinically relevant neurobehavioural problems were randomised to receive an intervention during four subsequent dexamethasone courses. The intervention consisted of two courses hydrocortisone (physiological dose 10 mg/m2/d in circadian rhythm), followed by two courses placebo, or vice versa. Neurobehavioural problems were assessed before and after each course using the parent-reported Strengths and Difficulties Questionnaire (SDQ) as primary end-point. Secondary end-points were sleep problems, health-related quality of life (HRQoL), hunger feeling, and parental stress, measured with questionnaires and actigraphy. A generalised mixed model was estimated to study the intervention effect. RESULTS: The median age was 5.5 years (range 3.0-18.8) and 61.5% were boys. The SDQ filled in by 51 primary caregivers showed no difference between hydrocortisone and placebo in reducing dexamethasone-induced neurobehavioral problems (estimated effect -2.05 (95% confidence interval (CI) -6.00-1.90). Also, no benefit from hydrocortisone compared to placebo was found for reducing sleep problems, hunger, parental stress or improving HRQoL. CONCLUSIONS: Hydrocortisone, when compared to placebo, had no additional effect in reducing clinically relevant dexamethasone-induced neurobehavioural problems. Therefore, hydrocortisone is not advised as standard of care for children with ALL who experience dexamethasone-induced neurobehavioural problems. TRIAL REGISTRATION: Netherlands Trial Register NTR6695/NL6507 (https://trialsearch.who.int/) and EudraCT 2017-002738-22 (https://eudract.ema.europa.eu/).

Which Health-Related Quality of Life Items Most Affect Acne Patients?

BACKGROUND: Health-related quality of life (HRQoL) assessment in patients with acne is recommended by several national guidelines. There are several acne-specific HRQoL instruments. OBJECTIVES: Participants of the European Academy of Dermatology and Venereology (EADV) Task Forces (TFs) on QoL and Patient Oriented Outcomes (PO) and Acne, Rosacea, and Hidradenitis Suppurativa (ARHS) agreed to scrutinize aspects of existing acne-specific HRQoL instruments for their relevance in international study. METHODS: Consensus agreement on items related to QoL was reached after an independent assessment by seven experts from the EADV TFs on QoL and PO, and a list of 97 items was prepared and proposed to a group of acne patients. In order to have data from patients to check if any important topics were overseen, another group of acne patients from participating countries was asked to list how acne influenced different aspects of their lives. RESULTS: Based on results obtained from 601 acne patients from nine countries, most of the items and topics showed low relevance for acne patients especially during the previous month or shorter time periods. Based on percentage of relevance and factor analysis, short (6 items) and long (45 items) lists of the most relevant topics were formed. CONCLUSION: Most of the items and topics from the initial list showed low relevance for acne patients. None of the identified acne-specific HRQoL instruments contain all the items that were deemed most relevant to acne patients. For this reason, participating members of the EADV TFs on QoL and PO, and ARHs are in the process of developing a new acne-specific HRQoL instrument.

Predictors of Persistent Somatic Symptoms in the General Population: A Systematic Review of Cohort Studies.

OBJECTIVE: Up to 10% of the general population experiences persistent somatic symptoms (PSS). Numerous studies in a variety of health domains are dedicated to identifying factors that are associated with PSS onset. The present study aimed to provide an overview of predictors for PSS onset in the general population and the related health domains. METHODS: A systematic search was performed identifying longitudinal cohort studies that examined factors associated with PSS onset in the general population. Included studies measured potential predictors before PSS onset and were categorized according to the dynamic biopsychosocial model. Four levels of evidence were discerned for predictors, based on the number of studies and percentage of consistent findings. RESULTS: In the 154 articles eligible for analysis, 27 PSS subtypes were studied, with primary focus on fibromyalgia (25.0%) and irritable bowel syndrome (23.3%). Of the >250 predictors of PSS onset, 46 were investigated more than once and showed consistent results. Strong evidence identifies biological (e.g., infections, body weight-related metrics), psychological (e.g., sleep problems, psychopathology), interpersonal (life events, childhood/interpersonal stress), contextual (employment), and health behavioral (health care utilization) predictors. CONCLUSIONS: The results provide strong evidence for factors from all dynamic biopsychosocial domains, although interpersonal and health behavioral factors are relatively under investigated. Thus, evidence suggests that reduction of predictors of PSS onset to a specific factor/domain may be too restrictive. There is no evidence that this differs per PSS subtype. Exploring all domains and measuring common factors across subtypes are essential to improve the clinical course of PSS.

Itch in patients with cutaneous T-cell lymphoma as a quality of life indicator.

Background: Cutaneous T-cell lymphoma (CTCL) is a chronic and progressive disease that has a major impact on quality of life (QoL). Objectives: To describe the impact of the different stages of disease in patients with classical mycosis fungoides, folliculotropic mycosis fungoides, and Sézary syndrome on generic- and dermatology-specific QoL and the relation with itch. Methods: A cross-sectional cohort study of patients with classical mycosis fungoides, folliculotropic mycosis fungoides, and Sézary syndrome was performed. Outcomes were the Skindex-29 score, Impact of Chronic Skin Disease on Daily Life which includes a visual analogue scale itch, and RAND-12. Results: One hundred six patients with CTCL were included. Compared to the total mycosis fungoides group, patients with Sézary syndrome had significantly worse Skindex-29 scores. Patients with advanced disease had statistically higher scores for the symptom (P = .007), functioning (P = .002), and total score (P = .012). The degree of itching was strongly correlated with the total Skindex-29 score (R = 0.713, P < .001). Conclusion: The different stages of CTCL can have a significant effect on multiple domains of generic- and dermatology-specific QoL. Itch was strongly correlated with QoL and therefore can be used as an overall QoL indicator. The effect on QoL, even in patients with early-stage disease, should not be underestimated.

Counterconditioning as Treatment to Reduce Nocebo Effects in Persistent Physical Symptoms: Treatment Protocol and Study Design.

Persistent physical symptoms have a high prevalence and a large impact for patients and society. To date, treatment effects for these symptoms are often limited. Nocebo effects (i.e., negative outcomes that are not attributable to active treatment components) have a substantial influence on treatment success and can be established via learning through classical conditioning. Therefore, interventions aimed at reducing nocebo effects by means of counterconditioning, in which an alternative association (inhibiting the previous association) is learned, could be a promising method for improving physical symptoms. In experimental studies, counterconditioning has been shown promising in reducing experimentally-induced nocebo effects on pain and itch. Application of counterconditioning procedures to reduce nocebo effects on clinical symptoms has yet to be researched. This paper provides a protocol of a 6-week counterconditioning intervention aimed at reducing nocebo effects and clinical pain in patients with fibromyalgia. A study in patients with fibromyalgia is proposed to examine the feasibility and potential effectiveness of this counterconditioning intervention as a novel treatment method for reducing nocebo effects and generalization to clinical pain symptoms. Results can help design an optimized treatment protocol for reducing nocebo effects, based on the experiences of participants and the first indications of treatment efficacy.

Quality of Life in Cutaneous T-cell Lymphoma Patients Receiving Mogamulizumab: Important Factors to Consider.

BACKGROUND: Erythrodermic cutaneous T-cell lymphoma (E-CTCL) is associated with a poor prognosis and severe symptoms. OBJECTIVE: To establish insights into the quality of life (QoL), expectations, and treatment satisfaction of E-CTCL patients receiving mogamulizumab. METHODS: Outcomes of this prospective cohort study conducted between September 2020 and August 2021 at the Leiden University Medical Center included the dermatology-specific QoL (Skindex-29), health-related QoL (RAND-12), degree of itch, pain, and fatigue (Visual Analogue Scale), patient's expectations, and treatment satisfaction (Client Satisfaction Questionnaire-8 (CSQ-8)), measured at baseline and after six months. RESULTS: 13 patients with E-CTCL were included. Most patients anticipated a positive treatment effect on symptoms. Five patients (46%) improved one or more clinical categories regarding the symptoms domain, six (55%) regarding emotions, four (36%) regarding functioning, and four (36%) regarding the overall Skindex-29 score compared to baseline. The Mental Component Score clinically improved from 31 (IQR 29-51) at baseline to 38 (IQR 25-51). The median VAS itch improved significantly from baseline (8 (IQR 7-10) vs. 3 (IQR 1-8), p = 0.024). Most patients (n = 7) were "very satisfied" with their treatment. LIMITATIONS: There was a limited number of patients due to the rarity of the disease. CONCLUSION: In general, mogamulizumab has a favorable effect on biochemical- and dermatology-specific QoL and physical functioning in some patients, with high treatment satisfaction. Itch especially improved over time in most patients. The treatment satisfaction was generally high. Mogamulizumab seems to be an effective treatment that improves the QoL in patients with E-CTCL.

Mind your words: Oncologists' communication that potentially harms patients with advanced cancer: A survey on patient perspectives.

BACKGROUND: Many complaints in medicine and in advanced illnesses are about communication. Little is known about which specific communications harm. This study explored the perspectives of patients with advanced cancer about potentially harmful communication behaviors by oncologists and helpful alternatives. METHODS: An online survey design was used that was based on literature scoping and patient/clinician/researcher input. Patients with advanced cancer (n = 74) reflected on the potential harmfulness of 19 communication situations. They were asked whether they perceived the situation as one in which communication could be harmful (yes/no). If they answered "yes," they were asked whether they perceived the examples as harmful (yes/no) or helpful (yes/no) and to provide open comments. Results were analyzed quantitatively and qualitatively (content analysis). RESULTS: Communication regarding information provision, prognosis discussion, decision-making, and empathy could be unnecessarily potentially harmful, and this occurred in various ways, such as making vague promises instead of concrete ones (92%), being too directive in decision-making (qualitative), and not listening to the patient (88%). Not all patients considered other situations potentially harmful (eg, introducing the option of refraining from anticancer therapy [49%] and giving too much [prognostic] information [60%]). Exploring each individual patients' needs/preferences seemed to be a precondition for helpful communication. CONCLUSIONS: This article provides patient perspectives on oncologists' unnecessarily potentially harmful communication behaviors and offers practical tools to improve communication in advanced cancer care. Both preventable pitfalls and delicate challenges requiring an individualized approach, where exploration might help, are described. Although providing difficult and unwelcome news is a core task for clinicians, this study might help them to do so while preventing potentially unnecessary harm.

Food anticipatory hormonal responses: A systematic review of animal and human studies.

Food anticipatory hormonal responses (cephalic responses) are proactive physiological processes, that allow animals to prepare for food ingestion by modulating their hormonal levels in response to food cues. This process is important for digesting food, metabolizing nutrients and maintaining glucose levels within homeostasis. In this systematic review, we summarize the evidence from animal and human research on cephalic responses. Thirty-six animal and fifty-three human studies were included. The majority (88 %) of studies demonstrated that hormonal levels are changed in response to cues previously associated with food intake, such as feeding time, smell, and sight of food. Most evidence comes from studies on insulin, ghrelin, pancreatic polypeptide, glucagon, and c-peptide. Moreover, impaired cephalic responses were found in disorders related to metabolism and food intake such as diabetes, pancreatic insufficiency, obesity, and eating disorders, which opens discussions about the etiological mechanisms of these disorders as well as on potential therapeutic opportunities.

Integrating Placebo Effects in General Practice: A Cross-Sectional Survey to Investigate Perspectives From Health Care Professionals in the Netherlands.

Objectives: Placebo effects, beneficial treatment outcomes due to non-active treatment components, play an important role in the overall treatment response. To facilitate these beneficial effects it is important to explore the perspectives of health care professionals (HCPs) on the integration of placebo effects in clinical care. Three themes were investigated: knowledge about placebo effects and factors that contribute to these, frequency of placebo use, and attitudes toward acceptability and transparency of placebo use in treatment. Methods: A cross-sectional survey, according to the Checklist for Reporting Results of Internet E-Surveys guidelines and STrengthening the Reporting of OBservational Studies in Epidemiology (STROBE), was conducted in the Netherlands in 2020. The survey was conducted in two samples: a (nested) short survey in 78 nurses during working shifts (sample 1) and an extended online survey in 47 general HCPs e.g., medical psychologists, oncologists, surgeons (sample 2). Results: Respondents from both samples reported to be somewhat or quite familiar with placebo effects (24.0 and 47.2%, respectively). From the six placebo mechanisms that were presented, mind-body interaction, positive expectations, and brain activity involved in placebo effects were rated as the most influential factors in placebo effects [F(5,119) = 20.921, p < 0.001]. The use of placebo effects was reported in 53.8% (n = 42) of the nurses (e.g., by inducing positive expectations), and 17.4% of the HCPs (n = 8 reported to make use of pure placebos and 30.4% of impure placebos (n = 14). Attitudes toward placebo use in treatment were acceptant, and transparency was highly valued (both up to 51%). Conclusions: The findings from this study address knowledge gaps in placebo effects in practice and provide insights in attitudes toward the integration of placebo effects from HCPs. Altogether, integrating these findings may potentially optimize treatment outcomes.

Pre-consultation information about one's physician can affect trust and treatment outcome expectations.

OBJECTIVE: Information about physicians' skills is increasingly available on the internet and consulted by patients. The impact of such information on patient expectations is largely unknown. The aim of the present study was to investigate whether information about the competence and empathic skills of a physician may impact pre-consultation trust and treatment outcome expectations in mild and severe medical conditions. METHODS: In this experimental web-based study, participants (n = 237) read vignettes describing competence and empathic skills (low versus high) of a fictive physician who would surgically remove a mole or melanoma (low versus high severity) following a 2 × 2 × 2 between-subjects design. Participants rated trust in the physician and treatment outcome expectations. RESULTS: High competence and empathy raised trust in the physician, regardless of condition severity. High competence and high empathy both also increased expected surgery success, while only high competence reduced expected side effects. CONCLUSION: Pre-consultation information highlighting a physician's competence and/or empathy may lead to higher trust in that physician, higher expected surgery success, and lower expected side effects. PRACTICE IMPLICATIONS: Physicians and hospital staff should be aware of the effects of written information available and might, for example, provide profiles on hospital websites emphasizing healthcare providers' competence and empathy.

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls.

BACKGROUND: Placebo or sham controls are the standard against which the benefits and harms of many active interventions are measured. Whilst the components and the method of their delivery have been shown to affect study outcomes, placebo and sham controls are rarely reported and often not matched to those of the active comparator. This can influence how beneficial or harmful the active intervention appears to be. Without adequate descriptions of placebo or sham controls, it is difficult to interpret results about the benefits and harms of active interventions within placebo-controlled trials. To overcome this problem, we developed a checklist and guide for reporting placebo or sham interventions. METHODS AND FINDINGS: We developed an initial list of items for the checklist by surveying experts in placebo research (n = 14). Because of the diverse contexts in which placebo or sham treatments are used in clinical research, we consulted experts in trials of drugs, surgery, physiotherapy, acupuncture, and psychological interventions. We then used a multistage online Delphi process with 53 participants to determine which items were deemed to be essential. We next convened a group of experts and stakeholders (n = 16). Our main output was a modification of the existing Template for Intervention Description and Replication (TIDieR) checklist; this allows the key features of both active interventions and placebo or sham controls to be concisely summarised by researchers. The main differences between TIDieR-Placebo and the original TIDieR are the explicit requirement to describe the setting (i.e., features of the physical environment that go beyond geographic location), the need to report whether blinding was successful (when this was measured), and the need to present the description of placebo components alongside those of the active comparator. CONCLUSIONS: We encourage TIDieR-Placebo to be used alongside TIDieR to assist the reporting of placebo or sham components and the trials in which they are used.

The Use of Expectancy and Empathy When Communicating With Patients With Advanced Breast Cancer; an Observational Study of Clinician-Patient Consultations.

Background: Information provision about prognosis, treatments, and side-effects is important in advanced cancer, yet also associated with impaired patient well-being. To counter potential detrimental effects, communication strategies based on placebo and nocebo effect mechanisms might be promising to apply in daily practice. This study aimed to provide more insight into how often and how oncologists use expectancy and empathy expressions in consultations with patients with advanced breast cancer. Methods: Forty-five consultations between oncologists and patients were audiotaped. To determine how often expectancy and empathy expressions were used, a coding scheme was created. Most consultations (n = 33) were coded and discussed by two coders, and the remaining 13 were coded by one coder. To determine how expectancy and empathy expressions were used, principles of inductive content analysis were followed. Results: Discussed evaluation (i.e., scan) results were good (n = 26,58%) or uncertain (n = 12,27%) and less often bad (n = 7,15%). Uncertain expectations about prognosis, treatment outcomes, and side effects occurred in 13, 38, and 27 consultations (29%, 85%, and 56%), followed by negative expectations in 8, 26, and 28 consultations (18%, 58%, and 62%) and positive expectations in 6, 34, and 17 consultations (13%, 76%, and 38%). When oncologists provided expectancy expressions, they tapped into three different dimensions: relational, personal, and explicit. Positive expectations emphasized the doctor-patient relationship, while negative expectations focused on the severity of the illness, and uncertainty was characterized by a balance between (potential) negative outcomes and hope. Observed generic or specific empathy expressions were regularly provided, most frequently understanding (n = 29,64% of consultations), respecting (n = 17,38%), supporting (n = 16,36%), and exploring (n = 16,36%). A lack of empathy occurred less often and contained, among others, not responding to patients' emotional concerns (n = 13,27% of consultations), interrupting (n = 7,16%), and an absence of understanding (n = 4,9%). Conclusion: In consultations with mainly positive or uncertain medical outcomes, oncologists predominantly made use of uncertain expectations (hope for the best, prepare for the worst) and used several empathic behaviors. Replication studies, e.g., in these and other medical situations, are needed. Follow-up studies should test the effect of specific communication strategies on patient outcomes, to counter potential negative effects of information provision. Studies should focus on uncertain situations. Ultimately, specific placebo and nocebo effect-inspired communication strategies can be harnessed in clinical care to improve patient outcomes.