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Introduction/Aims Methods Results Discussion The impact of treatment expectations on active treatment outcomes has not been specifically investigated in neuromuscular disorders. We thus explored in myasthenia gravis (MG) the contribution of patients' pre‐treatment expectations combined with an immunosuppressant drug on treatment outcomes.This pilot correlational study involved 17 patients with generalized MG, scheduled to start immunosuppressant azathioprine. At baseline, a healthcare professional administered: (i) the Stanford Expectations of Treatment Scale; (ii) a structured checklist paper form asking patients which side‐effects they expected to develop after starting azathioprine, coupled with a standardized framing of statements. Quantitative Myasthenia Gravis (QMG) score and daily dose of concomitant drugs were assessed by neurologists as clinical outcomes. Clinical outcomes and side‐effects were re‐assessed at 3 and 6 months, and clinical outcomes were monitored at 18 months.Clinically significant improvement in the QMG scores was achieved at 3 or 6 months. The level of state anxiety appeared to act as moderator of pre‐treatment negative expectations (strong, positive, indicative correlation, rs = .733, p = .001). The latter were, in turn, associated with the fulfillment of side‐effects that patients expected to develop with the new treatment (moderate, positive, indicative correlation, rs = .699, p = .002). No significant correlation emerged between positive and negative expectations.Our findings show a very quick clinical response and also suggest that patients' expectations and anxiety contributed to treatment outcomes, highlighting the importance of promoting safety messages and education strategies around newly introduced treatments. Future goals include evaluating a larger cohort that includes a matched control group. [ABSTRACT FROM AUTHOR]

AbstractMethods:Results:Conclusion:Objective: Patients and therapists possess psychotherapy-related expectations, such as their forecast of what processes will promote improvement. Yet, there remains limited research on such change process expectations, including their independent and dyadic associations with psychotherapy outcome. In this study, we explored the predictive influence of participants’ change process expectations, and their level of congruence, on therapeutic outcomes.Patients (N = 75) and therapists (N = 17) rated their change process expectations at baseline, and patients rated their psychological distress at baseline and three months into treatment.Multilevel models indicated that patients’ expectations for therapy to work through sharing sensitive contents openly and securely were positively related to subsequent improvement (B = −1.097; p = .007). On the other hand, patients’ expectations for therapy to work through the exploration of unexpressed contents were negatively related to improvement (B = 1.388; p = .049). When patients rated the sharing of sensitive contents openly and securely higher than their therapists, they reported better outcomes (B = −16.528; p = .035).These findings suggest that patients’ expectations produce diverse effects during early stages of treatment, and that patients’ belief in their ability to share sensitive contents may constitute a potential target to improve therapy effectiveness. [ABSTRACT FROM AUTHOR]

Background: Chronic pelvic pain is a complex condition. Few studies have focused on patient expectations of diagnosis and treatment in female chronic pelvic pain populations. Not knowing this information can lead to disparity and frustration between provider care and patient expectations resulting in poor patient outcomes. The aim of this study was to explore patient expectations and understanding of diagnosis prior to engaging in an interdisciplinary pelvic pain program. Methods: This is a cross sectional study of women enrolled in a tertiary Chronic Pain Center pelvic pain program in May 2019. Data were extracted from intake questionnaires to classify demographic variables and analyzed using descriptive statistics. Expectations and diagnoses were clustered in themes. Student's t -test was used to compare biomedical focus and biopsychosocial focus groups to the Pain Disability Index (PDI) and the EQ-5D results, and to compare self-reported diagnoses with treatment expectations between groups. Results: When asked about perceived diagnosis, 74% reported a gynecologic cause for their pain, 25.7% reported musculoskeletal causes, and 21.9% reported other health conditions. For treatment expectations: 46.6% believed they required rehabilitation, 30.8% responded "I don't know", and 21.2% reported perceived need for medication. There was no difference in PDI or EQ-5D scores between patients who identified perceived treatment options and those who reported "I don't know". Conclusions: Most patients identified a perceived cause for their pain, but there was uncertainty and ambiguity about treatment options. Understanding and addressing the perception and expectations of individuals is imperative to patient-centered care and can lead to improved outcomes. [ABSTRACT FROM AUTHOR]

Simple Summary: This study provides an insight into newly diagnosed patients with MF on patients' expectations, quality of life, and treatment satisfaction. These data can be used for adequate expectation management and provide a rationale for further evaluation of treatment regimens in these 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. [ABSTRACT FROM AUTHOR]

Asian American (AA) families remain critically underrepresented in clinical trials for ADHD interventions. Little is known about AA families' engagement in and outcomes of behavioral treatment (BT). Comparing AA families to other minoritized (OM) families and White families, this study examined parental cognitions, treatment engagement, and child outcomes of BT for ADHD inattentive type (ADHD-I). Path analyses were conducted utilizing data from a randomized controlled trial of BT for ADHD-I (N = 199 children, ages 7–11). Racial/ethnic differences in pretreatment parental self-competence and treatment expectations were examined for AA (n = 29) compared to OM (n = 35) and White (n = 135) parents. Two additional path models were conducted to examine the relations among race/ethnicity, pretreatment parental cognitions, treatment engagement, and posttreatment child outcomes. Direct effects of race/ethnicity and parental cognitions on posttreatment child outcomes as well as their indirect effects via treatment engagement were estimated. At pretreatment, AA parents endorsed lower parental self-competence and treatment expectations compared to OM and White parents. At posttreatment, AA parents reported fewer improvements in ADHD symptoms than White parents and lower global psychosocial improvement than OM parents. For all parents, treatment expectations positively predicted parent- and observer-rated treatment engagement, which in turn predicted child global psychosocial improvement. Path analyses indicated that the relationship between treatment expectations and posttreatment child global improvement was fully mediated by treatment engagement. These findings suggest that treatment expectations impede AA parents' engagement and success in BT. Implications for cultural adaptations of BT to improve AA families' treatment experience are discussed. [ABSTRACT FROM AUTHOR]

Objective: The objective of this research was to determine the efficacy and safety of an optimized informed consent (OIC) consultation for psychotherapy. Method: We performed a randomized controlled superiority online trial involving 2 weeks of treatment and 3 months of follow-up. One hundred twenty-two adults with mental disorders confirmed by structured interview currently neither in out- nor inpatient psychotherapy (mean age: 32, gender identity: 51.6% female, 1.6% diverse), were randomized. Participants received an information brochure about psychotherapy for self-study (treatment as usual [TAU]; n = 61) or TAU plus a one-session OIC utilizing expectation management, contextualization, framing, and shared decision making (n = 61). The primary outcome was treatment expectations at 2-week follow-up. Results: At 2-week follow-up, participants receiving OIC showed more positive treatment expectations compared to those receiving TAU only (mean difference: 0.70, 95% CI [0.36, 1.04]) with a medium effect size (d = 0.73). Likewise, OIC positively influenced motivation (d = 0.74) and adherence intention (d = 0.46). OIC entailed large effects on reduction of decisional conflict (d = 0.91) and increase of knowledge (d = 0.93). Participants receiving OIC showed higher capacity to consent to treatment (d = 0.63) and higher satisfaction with received information (d = 1.34) compared to TAU. No statistically significant group differences resulted for expected adverse effects of psychotherapy. Results were maintained at 3-month follow-up. Data sets for n = 10 cases (8.2%) were missing (postassessment n = 4, 2-week n = 6, 3-month follow-up n = 8). Conclusions: Explaining to patients how psychotherapy works via a short consultation was effective in strengthening treatment expectations and decision making in a nonharmful way. Further trials clarifying whether this effectively translates to better treatment outcomes are required. What is the public health significance of this article?: Among patients with mental disorders, an optimized informed consent consultation was superior to treatment as usual in promoting adequate treatment expectations, motivation, and capacity to consent to treatment while decreasing decisional conflict. Results support the efficacy and safety of an optimized informed consent using expectation management, contextualization, framing, and shared decision making among patients with mental disorders. The 35-min informed consent consultation can be easily implemented within trial sessions for a psychotherapy. This study highlights the clinical relevance of explaining to patients how psychotherapy works. [ABSTRACT FROM AUTHOR]

Abstract Background The treatment expectations of patients with psoriasis are essential for clinical outcomes. Objectives To examine disease‐ and treatment related intra‐ and interpersonal factors and their relation to treatment expectations among patients with psoriasis who initiate or switch biological therapy. Methods Consecutive adult patients with moderate to severe psoriasis who initiated or switched biological therapy completed a questionnaire regarding their disease‐ and treatment‐related expectations. Additionally, they filled out Patients' Attitudes and Beliefs Scale (PABS), Trust in Physician Scale (TPS) and Dermatology Life Quality Index (DLQI) questionnaires. Psoriasis Area Severity Index (PASI) was scored before and 3 months after treatment initiation. Results A total of 65 patients participated; 28% expected

Abstract Background Duchenne muscular dystrophy (DMD) is a rare, severe, fatal neuromuscular disease characterized by progressive atrophy and muscle weakness, resulting in loss of ambulation, decreased upper body function, and impaired cardiorespiratory function. This study aimed to generate qualitative evidence to describe the primary symptoms and impacts of DMD in ambulatory and non-ambulatory patients as reported by patient/caregiver dyads. Information was also gathered on expectations for future DMD treatments. Methods Forty-six dyads (caregiver and patients with DMD aged 4 to 22 years) participated in 60-min semi-structured video interviews. Interview transcripts were analyzed using thematic analysis. Differences in experiences with DMD by ambulation status were examined. Results Mean ages of ambulatory (n = 28) and non-ambulatory participants (n = 18) were 8.7 and 11.3 years, respectively, with an average age of diagnosis of 3.7 years (SD = 2.3). The primary symptoms reported by both groups were lack of strength (ambulatory: n = 28, 100.0%; non-ambulatory: n = 17, 94.4%) and fatigue (ambulatory: n = 24, 85.7%; non-ambulatory: n = 14, 77.8%). Physical function was the domain that was most impacted by DMD, with participants describing progressive decline of physical function due to loss of physical strength as the primary defining feature of the disease across all stages of ambulatory ability. For those who maintained ambulatory ability at the time of the interview, physical function impacts described impaired mobility (e.g., climbing stairs: n = 16, 57.1%; running: n = 13, 46.4%), impaired upper body function, in particular fine motor skills like holding a pen/pencil or buttoning clothes (n = 17, 60.7%), problem with transfers (e.g., getting off the floor: n = 10, 35.7%), and activities of daily living (ADLs; n = 15, 53.6%). For non-ambulatory participants, the functional impacts most frequently described were problems with transfers (e.g., getting in/out of bed: n = 13, 72.2%; getting in/out of chair or position in bed: both n = 10, 55.6%), impaired upper body function (reaching: n = 14, 77.8%), and ADLs (n = 15, 83.3%). Meaningful treatment goals differed by ambulatory status; for ambulatory participants, goals included maintaining current functioning (n = 20, 71.4%), improving muscle strength (n = 7, 25.9%), and reducing fatigue (n = 6, 22.2%). For non-ambulatory participants, these included increased upper body strength (n = 8, 42.1%) and greater independence in ADLs (n = 6, 31.6%). A preliminary conceptual model was developed to illustrate the primary symptoms and physical function impacts of DMD and capture their relationship to disease progression. Conclusion This study contributes to the limited qualitative literature by characterizing impacts of physical limitations and symptoms of DMD on disease progression and thus providing insights into the lived experience with DMD. Differences in treatment goals were also identified based on ambulatory status. Taken together, these findings can help inform patient-centered measurement strategies for evaluating outcomes in DMD clinical research.

RationalePsychedelic research continues to garner significant public and scientific interest with a growing number of clinical studies examining a wide range of conditions and disorders. However, expectancy effects and effective condition masking have been raised as critical limitations to the interpretability of the research.ObjectiveIn this article, we review the many methodological challenges of conducting psychedelic clinical trials and provide recommendations for improving the rigor of future research.ResultsAlthough some challenges are shared with psychotherapy and pharmacology trials more broadly, psychedelic clinical trials have to contend with several unique sources of potential bias. The subjective effects of a high-dose psychedelic are often so pronounced that it is difficult to mask participants to their treatment condition; the significant hype from positive media coverage on the clinical potential of psychedelics influences participants' expectations for treatment benefit; and participant unmasking and treatment expectations can interact in such a way that makes psychedelic therapy highly susceptible to large placebo and nocebo effects. Specific recommendations to increase the success of masking procedures and reduce the influence of participant expectancies are discussed in the context of study development, participant recruitment and selection, incomplete disclosure of the study design, choice of active placebo condition, as well as the measurement of participant expectations and masking efficacy.ConclusionIncorporating the recommended design elements is intended to reduce the risk of bias in psychedelic clinical trials and thereby increases the ability to discern treatment-specific effects of psychedelic therapy.

Background: Duchenne muscular dystrophy (DMD) is a rare, severe, fatal neuromuscular disease characterized by progressive atrophy and muscle weakness, resulting in loss of ambulation, decreased upper body function, and impaired cardiorespiratory function. This study aimed to generate qualitative evidence to describe the primary symptoms and impacts of DMD in ambulatory and non-ambulatory patients as reported by patient/caregiver dyads. Information was also gathered on expectations for future DMD treatments. Methods: Forty-six dyads (caregiver and patients with DMD aged 4 to 22 years) participated in 60-min semi-structured video interviews. Interview transcripts were analyzed using thematic analysis. Differences in experiences with DMD by ambulation status were examined. Results: Mean ages of ambulatory (n = 28) and non-ambulatory participants (n = 18) were 8.7 and 11.3 years, respectively, with an average age of diagnosis of 3.7 years (SD = 2.3). The primary symptoms reported by both groups were lack of strength (ambulatory: n = 28, 100.0%; non-ambulatory: n = 17, 94.4%) and fatigue (ambulatory: n = 24, 85.7%; non-ambulatory: n = 14, 77.8%). Physical function was the domain that was most impacted by DMD, with participants describing progressive decline of physical function due to loss of physical strength as the primary defining feature of the disease across all stages of ambulatory ability. For those who maintained ambulatory ability at the time of the interview, physical function impacts described impaired mobility (e.g., climbing stairs: n = 16, 57.1%; running: n = 13, 46.4%), impaired upper body function, in particular fine motor skills like holding a pen/pencil or buttoning clothes (n = 17, 60.7%), problem with transfers (e.g., getting off the floor: n = 10, 35.7%), and activities of daily living (ADLs; n = 15, 53.6%). For non-ambulatory participants, the functional impacts most frequently described were problems with transfers (e.g., getting in/out of bed: n = 13, 72.2%; getting in/out of chair or position in bed: both n = 10, 55.6%), impaired upper body function (reaching: n = 14, 77.8%), and ADLs (n = 15, 83.3%). Meaningful treatment goals differed by ambulatory status; for ambulatory participants, goals included maintaining current functioning (n = 20, 71.4%), improving muscle strength (n = 7, 25.9%), and reducing fatigue (n = 6, 22.2%). For non-ambulatory participants, these included increased upper body strength (n = 8, 42.1%) and greater independence in ADLs (n = 6, 31.6%). A preliminary conceptual model was developed to illustrate the primary symptoms and physical function impacts of DMD and capture their relationship to disease progression. Conclusion: This study contributes to the limited qualitative literature by characterizing impacts of physical limitations and symptoms of DMD on disease progression and thus providing insights into the lived experience with DMD. Differences in treatment goals were also identified based on ambulatory status. Taken together, these findings can help inform patient-centered measurement strategies for evaluating outcomes in DMD clinical research. [ABSTRACT FROM AUTHOR]

Background: Former studies demonstrated that negative outcome expectations (OE) toward psychotherapy predict unfavorable psychotherapy outcomes. Critically, the measurement of OE is limited to direct measures that could be subject to self-presentational distortions. This study aimed to validate an online single category implicit association test (SC-IAT) to measure OE toward psychotherapy indirectly. Methods: We conducted three direct measures of OE, the Therapy SC-IAT, and a (control) Flower SC-IAT in a large sample (N = 705). Results: The Therapy SC-IAT correlated with most direct measures of OE (convergent validity) but not with measures of flower associations (discriminant validity). In exploratory analyses, we found that direct and indirect measurements of OE were related to prior experiences with psychotherapy. Conclusion: We discuss ways to improve the indirect-direct correlations and suggest that our newly developed indirect measure could complement the assessment of expectations in research and clinical practice. [ABSTRACT FROM AUTHOR]

Background: Placebo effects are a well-established phenomenon in the treatment of depression. However, the mechanism underlying these effects are not fully understood. Treatment expectations are considered one explanation for why placebos work. Treatment expectations are likely to be affected by clinician-patient interactions. This study aims to investigate the role of the communicated treatment rationale in modulating treatment expectations and its effects on the treatment outcomes of a pharmacological and a psychological active placebo intervention for depression. In this study, treatment expectations are modulated by presenting illness models that are either congruent or incongruent with the treatment intervention that follows. Methods: This 2 × 2 randomized controlled trial will involve patients with major depression. Participants will either receive a biological or a psychological illness model from a clinician. Following this, they are randomly assigned to receive either a pharmacological or a psychological active placebo intervention. The illness model and the treatment are either congruent or incongruent with each other, resulting in four groups. In addition, a natural course control group will be included. Discussion: This study will provide insights into the mechanism of expectation modulation in active placebo treatments for major depression. The results may provide insights for clinicians to improve their communication with patients by focusing on treatment expectations. By identifying the factors that contribute to placebo effects, this study has the potential to improve the effectiveness of existing depression treatments and reduce the burden of this highly prevalent mental health condition. Trial registration: This trial has been registered prospectively at ClinicalTrials.gov under the identifier: NCT04719663. Registered on January 22, 2021. [ABSTRACT FROM AUTHOR]

The role of psychological factors in the pathophysiology and treatment of chronic visceral pain in disorders of gut-brain interactions (DGBI) is increasingly appreciated. Placebo research has underscored that expectations arising from the psychosocial treatment context and from prior experiences shape treatment responses. However, effects of negative expectations, i.e., nocebo effects, as they are likely crucial elements of DGBI patients' clinical reality, have thus far only rarely been investigated in the context of visceral pain, with untapped potential for improved prevention and treatment. The experimental randomized-controlled pain study "NoVis," carried out within the Collaborative Research Center (CRC) 289 ("Treatment Expectation"), aims to close gaps regarding the generation and persistence of nocebo effects in healthy volunteers. It is designed to elucidate effects of negative expectations in a multiple-threat paradigm with intensitymatched rectal distensions and cutaneous thermal stimuli, allowing to test nocebo effects in the visceral and somatic pain modalities. Negative expectations are experimentally induced by elements of doctor-patient communication (i.e., instruction) and/or by surreptitious amplification of symptom intensity (i.e., experience/learning) within a treatment context. Accordingly, the repeated measures between-subject design contains the between-group factors "treatment instruction" (negative vs. control) and "treatment experience" (negative vs. control), with volunteers randomized into four experimental groups undergoing several pain stimulation phases (repeated factor). This allows to compare the efficacy of instruction vs. experience, and more importantly, their combined effects on the magnitude of negative expectations and their impact on pain responses, which we expect will be greatest for the visceral modality. After a Baseline, short-term effects are assessed during a test phase accomplished on study day 1 (Test-1 Phase). To explore the persistence of effects, a second test phase is accomplished 1 week later (Test-2 Phase). Effects of negative expectations within and across pain modalities are assessed at the subjective and objective levels, with a focus on psychophysiological and neuroendocrine measures related to stress, fear, and anxiety. Since nocebo effects can play a considerable role in the generation, maintenance, or worsening of chronic visceral pain, and may even constitute risk factors for treatment failure, knowledge from experimental nocebo research has potential to improve treatment outcomes in DGBI and other clinical conditions associated with chronic visceral pain. [ABSTRACT FROM AUTHOR]

Background: Antidepressant placebos and, more generally, positive treatment expectations, have been shown to alter positive and negative affect in prior studies. However, much of this work has heavily relied on self-report measures which are prone to demand effects in the context of explicit expectation manipulations. In addition, there is little knowledge about personality variables which moderate antidepressant placebo responses and may help us identify individualized and targeted interventions. Methods: Inert pills were administered to N=56 healthy participants and treatment expectations were manipulated by labeling each pill as either an inactive placebo or an active antidepressant. Thereafter, participants underwent an experimental induction of depressed mood with a musical Velten approach and their affective states were assessed via ratings and heart rate. Furthermore, trait anhedonia was measured as a depression-related personality variable which may moderate antidepressant placebo responses. Results: While the depressed mood induction led to a general reduction of self-reported positive affect, antidepressant treatment expectations reduced cardiac slowing to depressed mood selectively in high vs. low anhedonic subjects. Limitations: No main effects of expectation manipulation were revealed, but an interaction with regard to cardiac response involving trait anhedonia not paralleled by self-reports. Conclusion: The present findings suggest that individuals with higher levels of trait anhedonia may benefit more from antidepressant placebo effects than low anhedonic individuals, and stress the importance of investigating placebo responses beyond self-reports at the physiological level.

Abstract Background Placebo effects are a well-established phenomenon in the treatment of depression. However, the mechanism underlying these effects are not fully understood. Treatment expectations are considered one explanation for why placebos work. Treatment expectations are likely to be affected by clinician-patient interactions. This study aims to investigate the role of the communicated treatment rationale in modulating treatment expectations and its effects on the treatment outcomes of a pharmacological and a psychological active placebo intervention for depression. In this study, treatment expectations are modulated by presenting illness models that are either congruent or incongruent with the treatment intervention that follows. Methods This 2 × 2 randomized controlled trial will involve patients with major depression. Participants will either receive a biological or a psychological illness model from a clinician. Following this, they are randomly assigned to receive either a pharmacological or a psychological active placebo intervention. The illness model and the treatment are either congruent or incongruent with each other, resulting in four groups. In addition, a natural course control group will be included. Discussion This study will provide insights into the mechanism of expectation modulation in active placebo treatments for major depression. The results may provide insights for clinicians to improve their communication with patients by focusing on treatment expectations. By identifying the factors that contribute to placebo effects, this study has the potential to improve the effectiveness of existing depression treatments and reduce the burden of this highly prevalent mental health condition. Trial registration This trial has been registered prospectively at ClinicalTrials.gov under the identifier: NCT04719663. Registered on January 22, 2021.

The role of psychological factors in the pathophysiology and treatment of chronic visceral pain in disorders of gut-brain interactions (DGBI) is increasingly appreciated. Placebo research has underscored that expectations arising from the psychosocial treatment context and from prior experiences shape treatment responses. However, effects of negative expectations, i.e., nocebo effects, as they are likely crucial elements of DGBI patients’ clinical reality, have thus far only rarely been investigated in the context of visceral pain, with untapped potential for improved prevention and treatment. The experimental randomized-controlled pain study “NoVis,” carried out within the Collaborative Research Center (CRC) 289 (“Treatment Expectation”), aims to close gaps regarding the generation and persistence of nocebo effects in healthy volunteers. It is designed to elucidate effects of negative expectations in a multiple-threat paradigm with intensity-matched rectal distensions and cutaneous thermal stimuli, allowing to test nocebo effects in the visceral and somatic pain modalities. Negative expectations are experimentally induced by elements of doctor-patient communication (i.e., instruction) and/or by surreptitious amplification of symptom intensity (i.e., experience/learning) within a treatment context. Accordingly, the repeated measures between-subject design contains the between-group factors “treatment instruction” (negative vs. control) and “treatment experience” (negative vs. control), with volunteers randomized into four experimental groups undergoing several pain stimulation phases (repeated factor). This allows to compare the efficacy of instruction vs. experience, and more importantly, their combined effects on the magnitude of negative expectations and their impact on pain responses, which we expect will be greatest for the visceral modality. After a Baseline, short-term effects are assessed during a test phase accomplished on study day 1 (Test-1 Phase). To explore the persistence of effects, a second test phase is accomplished 1 week later (Test-2 Phase). Effects of negative expectations within and across pain modalities are assessed at the subjective and objective levels, with a focus on psychophysiological and neuroendocrine measures related to stress, fear, and anxiety. Since nocebo effects can play a considerable role in the generation, maintenance, or worsening of chronic visceral pain, and may even constitute risk factors for treatment failure, knowledge from experimental nocebo research has potential to improve treatment outcomes in DGBI and other clinical conditions associated with chronic visceral pain.

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.

Background and Objectives: This study describes patients' prognostic awareness and palliative care use in the setting of immunotherapy for metastatic non-small cell lung cancer (mNSCLC). Design: We surveyed 60 mNSCLC patients receiving immunotherapy at a large academic medical center; conducted follow-up interviews with 12 survey participants; and abstracted palliative care use, advance directive completion, and death within a year of survey completion from the medical record. Results: Forty seven percent of patients surveyed thought they would be cured; 83% were not interested in palliative care. Interviews suggested oncologists emphasized therapeutic options when discussing prognosis and that commonly used descriptions of palliative care may exacerbate misperceptions. Only 7% had received outpatient palliative care and 8% had an advance directive a year after the survey; only 16% of the 19 patients who died had received outpatient palliative care. Conclusions: Interventions are needed to facilitate prognostic discussions and outpatient palliative care during immunotherapy. Clinical Trial Registration Number NCT03741868. [ABSTRACT FROM AUTHOR]

Introduction: Limb girdle muscular dystrophies (LGMDs) are a group of rare and heterogeneous disorders involving progressive wasting of shoulder and pelvic girdle musculature. This study aimed to generate qualitative evidence on patient and caregiver experiences with symptoms and impacts of LGMD on overall function and daily life for sarcoglycanopathy subtypes 2C/R5, 2D/R3, and 2E/R4. Methods: Twenty-three individuals with LGMD with (n = 5) or without (n = 18) a caregiver participated in 60-minute semi-structured video interviews. Interview transcripts were analyzed using thematic analysis. Differences in patient experience by ambulation status and LGMD subtype were examined. Results: Participants were ambulatory (n = 14) and non-ambulatory (n = 9), representing three subtypes: 2C/R5 (n = 4), 2D/R3 (n = 12), and 2E/R4 (n = 7), with mean age of 34.8 years (SD = 16.08). 56.5% identified as female. Conceptual saturation was achieved within 18/23 interviews. Ambulatory participants identified difficulty with complex physical activities, e.g., running (n = 11, 78.6%), physical strength (n = 14, 100%), and difficulty with transfers, e.g., difficulty getting off the floor (n = 10, 71.4%). All non-ambulatory participants discussed problems with activities of daily living (ADLs) and transfers, e.g., getting in/out of bed and upper extremity function, particularly reaching (n = 8, 88.9%) and fine motor skills (n = 6, 66.7%). Fatigue and pain were reported by the majority of participants (n = 16, 69.6% and n = 19, 82.6%, respectively). A conceptual disease model was developed illustrating symptoms and impacts and their relationships to disease stage, capturing the patient experience across LGMD disease trajectory. Conclusions: This study contributes to the limited evidence describing the patient experience of living with LGMD. The conceptual model can inform patient-centered assessment in future LGMD clinical trials. [ABSTRACT FROM AUTHOR]

Background: Exposure-based treatments have demonstrated some of the largest effect sizes in the treatment of specific phobias (SP). There are different ways of delivering exposure such as Augmented Reality Exposure which has become an interesting alternative to In Vivo Exposure for treating SP. The present study aimed to investigate the therapeutic alliance and treatment expectations as possible predictors of treatment outcomes in these two exposure treatment conditions. Methods: Participants were 63 adults who met diagnostic criteria for the diagnosis of a SP of cockroaches or spiders (animal subtype). Patients were randomized to receive a one-session treatment of either In Vivo Exposure (N = 31) or Augmented Reality Exposure (N = 32). The assessment protocol included diagnostic, as well as primary-, and secondary outcome measures. Materials included the Behavioral Avoidance Test for measuring symptoms and outcomes, the Expectations and Satisfaction Questionnaire, and the Working Alliance Inventory. We ran multilevel analyses for the study of predictors controlling for the treatment effect conditions. Results: Results showed a significant effect of expectations on treatment outcomes (specifically avoidance and beliefs scores). The therapeutic alliance did not have a significant effect on treatment outcome. Patients reduced their symptoms of phobia. Conclusion: These results empirically support treatment expectations as a relevant predictor of change in exposure treatments for SP. [ABSTRACT FROM AUTHOR]

Murlidhar Rajagopalan,1 Sunil Dogra,2 Kiran Godse,3 Bikash Ranjan Kar,4 Sai Krishna Kotla,5 Shekhar Neema,6 Abir Saraswat,7 Swapnil Deepak Shah,8 Nina Madnani,9,10 Vidyadhar Sardesai,11 Rajiv Sekhri,12 Sachin Varma,13 Sandeep Arora,14 Pallavi Kawatra15 1Department of Dermatology, Apollo Hospital, Chennai, India; 2Department of Dermatology Venereology & Leprology Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, 160012, India; 3DY Patil University School of Medicine, Navi Mumbai, India; 4Department of Dermatology, IMS and SUM Hospital, Bhubaneshwar, Odisha, India; 5Department of Dermatology, Yashodha Hospital, Secunderabad, India; 6Department of Dermatology, Armed Forces Medical College, Pune, Maharashtra, India; 7Indushree Skin Clinic, Lucknow, India; 8Department of Dermatology, Ashwini Rural Medical College, Solapur, India; 9Hinduja Hospital, Mumbai, India; 10Sir. H. N. Reliance Hospital, Mumbai, India; 11Bharati Vidyapeeth Medical College, Pune, India; 12Fortis Hospital, Noida, India; 13Skinvita Clinic, Kolkata, West Bengal, India; 14Army College of Medical Sciences, New Delhi, India; 15Novartis, Mumbai, IndiaCorrespondence: Murlidhar Rajagopalan, Department of Dermatology, Apollo Hospital, Chennai, India, Email docmurli@gmail.comPurpose: The primary objective of the study was to understand the therapeutic inertia in treatment and management of plaque psoriasis among dermatologists, along with determining the preferred treatment choices for management of plaque psoriasis; it also included the resulting treatment satisfaction among patients. The secondary objective was to identify the gaps in terms of knowledge and attitude among dermatologists and the expectations of patients.Patients and Methods: A multicentre, cross-sectional quantitative survey was conducted among dermatologists and patients with moderate to severe plaque psoriasis across India. The interviews were conducted either face to face or via telephone between September and November 2020, using structured and validated questionnaires based on specific themes. The data obtained were statistically analysed, wherever applicable.Results: Overall, 207 adult patients with moderate-to-severe plaque psoriasis and 303 dermatologists were interviewed. Post experiencing symptoms, 44% of the patients visited general physicians for treatment and there was an average 7.8-month delay by the patients to consult a dermatologist. Approximately one-fourth of patients used home remedies before seeking medical help. One-third of dermatologists used the Psoriasis Area and Severity Index (PASI) for assessing the disease severity. Majority of dermatologists preferred combination therapy for their patients. The lack of quick resolution and side effects were the major reasons for changing the treatment. Overall, only 35% of the patients complied to current treatment. Satisfaction with existing forms of therapies was highest for mild plaque psoriasis (62%) as confirmed by dermatologists, while 52% of the overall patients were satisfied with their therapy. Majority of the patients (64%) affirmed living with plaque psoriasis impacted their lives.Conclusion: This first-of-its-kind survey in India highlighted the gaps in terms of the disease journey between dermatologists and patients. The survey emphasises the need for shared decision-making and may benefit dermatologists in suggestive modifications of the treatment algorithm and disease management in clinical settings.Keywords: therapeutic inertia, psoriasis, adherence, treatment expectations, treatment goals, diagnosis

Objective: This study aimed to assess clinicians' attitudes and their current clinical practices regarding informed consent for psychotherapy. Method: A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey. Results: Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%). Conclusions: Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision‐making and might have a positive influence on treatment expectations and outcomes. [ABSTRACT FROM AUTHOR]

Simple Summary: Patients with erythrodermic cutaneous T-cell lymphoma often experience severe symptoms. This study provides an insight into the impact of the disease, mogamulizumab treatment, and essential patient-reported outcomes. The data on patients' expectation, quality of life, and treatment satisfaction can especially be used in the counseling of future patients. 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. [ABSTRACT FROM AUTHOR]

Background: Prevention of premature deaths due to asthma requires continued disease control through efforts of both patients and healthcare providers. The expectations of patients have been shown to influence treatment adherence and disease control. Methodology: We conducted a hospital-based sequential exploratory mixed methods study and used definitions of the Global Initiative for Prevention of Asthma (GINA). We recruited 80 asthma patients in a tertiary public health facility of central India. We assessed treatment expectations, health literacy, awareness, behavioural risk factors, self-care, treatment adherence, and disease control. We conducted a thematic analysis of qualitative data through manual inductive coding and used statistical software R version-3.6.1 for quantitative analysis. Results: Sixty-seven (83.75%) patients expected that the current doctor would help them achieve 'cure', while 28 (35%) expected to obtain information about asthma. 81.2% and 77.5% of participants had inadequate health literacy and inadequate awareness, respectively. 73.8% were using inhalers and 21.2% were not using any treatment. Forced expiratory volume in 1 (FEV1) and Forced vital capacity (FVC) values were available for only 46.25%, while a meagre 6.25% were using peak-flow meter for self-monitoring. Though 21.2% reported optimal treatment adherence, 27.5% had good control. We found the expectation of cure and poor health literacy being significantly related to sub-optimal treatment adherence. We didn't find any association between the expectations of patients and their disease control. Conclusion: Asthma patients in our setting mostly expected to get cured. The unrealistic expectation of 'cure' is related to poor treatment adherence and possibly poor disease control.

Positive treatment expectations demonstrably shape treatment outcomes regarding pain and disability in patients with chronic low back pain. However, knowledge about positive and negative treatment expectations as putative predictors of interindividual variability in treatment outcomes is sparse, and the role of other psychological variables of interest, especially of depression as a known predictor of long-term disability, is lacking. We present results of the first prospective study considering expectations in concert with depression in a sample of 200 patients with chronic low back pain undergoing an inpatient interdisciplinary multimodal pain therapy. We analyzed the characteristics of pain and disability, treatment expectation, and depression assessed at the beginning (T0), at the end of (T1), and at 3-month follow-up (T2) of interdisciplinary multimodal pain therapy. Treatment expectations did emerge as a significant predictor of changes in pain intensity and disability, respectively, showing that positive expectations were associated with better treatment outcomes. Mediation analyses revealed a partially mediating effect of treatment expectations on the relation between depression and pain outcomes. PERSPECTIVE: These results expand knowledge regarding the role of treatment expectations in individual treatment outcome trajectories in chronic pain patients, paving the way for much-needed efforts toward optimizing patient expectations and personalized approaches in clinical settings., (Copyright © 2024 United States Association for the Study of Pain, Inc. Published by Elsevier Inc. All rights reserved.)

Background: Prevention of premature deaths due to asthma requires continued disease control through efforts of both patients and healthcare providers. The expectations of patients have been shown to influence treatment adherence and disease control. Methodology: We conducted a hospital-based sequential exploratory mixed methods study and used definitions of the Global Initiative for Prevention of Asthma (GINA). We recruited 80 asthma patients in a tertiary public health facility of central India. We assessed treatment expectations, health literacy, awareness, behavioural risk factors, self-care, treatment adherence, and disease control. We conducted a thematic analysis of qualitative data through manual inductive coding and used statistical software R version-3.6.1 for quantitative analysis. Results: Sixty-seven (83.75%) patients expected that the current doctor would help them achieve 'cure', while 28 (35%) expected to obtain information about asthma. 81.2% and 77.5% of participants had inadequate health literacy and inadequate awareness, respectively. 73.8% were using inhalers and 21.2% were not using any treatment. Forced expiratory volume in 1 (FEV1) and Forced vital capacity (FVC) values were available for only 46.25%, while a meagre 6.25% were using peak-flow meter for self-monitoring. Though 21.2% reported optimal treatment adherence, 27.5% had good control. We found the expectation of cure and poor health literacy being significantly related to sub-optimal treatment adherence. We didn't find any association between the expectations of patients and their disease control. Conclusion: Asthma patients in our setting mostly expected to get cured. The unrealistic expectation of 'cure' is related to poor treatment adherence and possibly poor disease control. [ABSTRACT FROM AUTHOR]

There is limited research on the concordance between client perceptions and clinician standards of the degree of symptom change required to achieve meaningful therapeutic improvement. This was investigated in an adult sample (N = 147) who received trauma-focused cognitive-behavioral therapies for posttraumatic stress disorder (PTSD). We examined whether clients' benchmarks of change were related to actual outcomes and the relationship between client expectations and their treatment outcomes. Clients completed measures indexing the level of symptom reduction required (in their view) to reflect a benefit or recovery from treatment and treatment expectations. Actual PTSD severity was indexed pre- and posttreatment via self-report and clinician-administered interview. Results demonstrated that the amount of change clients said they required to experience a benefit or recovery was significantly larger than typical clinical research standards. Nonetheless, the majority of client benchmarks of change (79.7-81.8%) were consistent with clinical research standards of what constitutes benefit or recovery. Client benchmarks were generally positively correlated with their actual outcomes. Clients' belief that treatment would be successful was associated with greater reductions in PTSD symptoms. These findings provide preliminary evidence that the standards used to determine clinically significant change are somewhat consistent with clients' own perceptions of required symptom change. [ABSTRACT FROM AUTHOR]

The 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. In 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). After 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. This 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. • Post-COVID-19 condition is asscociated with long-term health issues. • A biopsychosocial approach seems necessary to enhance treatment of post-COVID. • We examined the impact of expectations on post-COVID neurological rehab outcomes. • Side-effect expectations predicted illness-related disability and patients'fitness. • Managing patient expectations is crucial for optimal rehab outcomes. [ABSTRACT FROM AUTHOR]

Introduction Positive treatment expectations among patients are associated with reduced symptoms and reduced negative emotions, stress and anxiety. Patient expectations may be influenced by practitioners who focus on increasing positive treatment effects and reducing psychological and physiological stress. Objectives This study examined clinicians’ self-reported utilization of expectancy effects as additive effects to active treatments. Methods We applied a questionnaire to investigate clinicians’ utilization of patients´ treatment expectations. The items mapped reasons for increasing patient expectations, ways through which this was done, the frequency and efficiency of increasing expectations, and the understanding of underlying mechanisms of increasing patient expectations. Nurses (N=84) and medical doctors (N=49) employed in general practitioners’ offices, hospitals, nursing homes and home health care services, responded anonymously. Results When asked if they had tried to influence patient’s expectations to achieve an additive effect to active treatment, 71.2% reported that they had done so at least one time over the last year, 18.5% at least once per month, 16.9% at least once per week and 32.3% at a daily basis. Neither profession nor practitioner sex influenced these results. The two most frequently reported reasons for trying to influence expectations were to increase the effect of an active treatment and to calm the patient. Optimism and empathy were the two most frequently reported ways through which expectations were influenced. Conclusions The strategy of utilizing expectation effects as additive effects to active treatment was frequent among the respondents. The main reported reasons were to increase treatment effects and reduce patients’ stress through expressing optimism and empathy. Disclosure No significant relationships.

Placebo research has established the pivotal role of treatment expectations in shaping symptom experience and patient-reported treatment outcomes. Perceived treatment efficacy constitutes a relevant yet understudied aspect, especially in the context of the gut-brain axis with visceral pain as key symptom. Using a clinically relevant experimental model of visceral pain, we elucidated effects of pre-treatment expectations on post-treatment perceived treatment efficacy as an indicator of treatment satisfaction in a translational placebo intervention. We implemented positive suggestions regarding intravenous treatment with a spasmolytic drug (in reality saline), herein applied in combination with two series of individually calibrated rectal distensions in healthy volunteers. The first series used distension pressures inducing pain (pain phase). In the second series, pressures were surreptitiously reduced, modeling pain relief (pain relief phase). Using visual analog scales (VAS), expected and perceived treatment efficacy were assessed, along with perceived pain intensity. Manipulation checks supported that the induction of positive pre-treatment expectations and the modeling of pain relief were successful. Generalized Linear Models (GLM) were implemented to assess the role of inter-individual variability in positive pre-treatment expectations in perceived treatment efficacy and pain perception. GLM indicated no association between pre-treatment expectations and perceived treatment efficacy or perceived pain for the pain phase. For the relief phase, pre-treatment expectations (p = 0.024) as well as efficacy ratings assessed after the preceding pain phase (p < 0.001) were significantly associated with treatment efficacy assessed after the relief phase, together explaining 54% of the variance in perceived treatment efficacy. The association between pre-treatment expectations and perceived pain approached significance (p = 0.057) in the relief phase. Our data from an experimental translational placebo intervention in visceral pain support that reported post-treatment medication efficacy is shaped by pre-treatment expectations. The observation that individuals with higher positive expectations reported less pain and higher treatment satisfaction after pain relief may provide first evidence that perceived symptom improvement may facilitate treatment satisfaction. The immediate experience of symptoms within a given psychosocial treatment context may dynamically change perceptions about treatment, with implications for treatment satisfaction, compliance and adherence of patients with conditions of the gut-brain axis. [ABSTRACT FROM AUTHOR]

Expectations can influence the outcome and the process of psychotherapy. Hence, this article aims to overview the types of expectations, i.e., outcome, treatment and change. Both patients' and therapists' expectations are considered. Furthermore, determinants of expectations and moderators/mediators of expectations-outcome relationship are described. We provided theories that try to explain the influence of expectations and their relationship with the psychotherapy process. Various instruments for measuring expectations and practical advice to manage expectations in psychotherapy will be discussed. Clinicians should become increasingly aware of their own and clients' expectations. Future studies should investigate the impact of every kind of expectation and its moderation/mediation role with other psychotherapy processes. [ABSTRACT FROM AUTHOR]

Objectives: The objective of this study was to describe self-care practice during radiotherapy for cancer and to identify potential differences between practitioners and non-practitioners of self-care regarding sociodemographic, clinical, functional, and quality-of-life-related characteristics. Methods: In this descriptive study, 439 patients (87% response rate) undergoing radiotherapy responded to a study questionnaire regarding self-care, sociodemographic, clinical (eg, experienced symptoms), functional, and quality-of-life-related characteristics. Results: Of the 439 patients, 189 (43%) practiced at least one self-care strategy, while 250 (57%) did not. In total, the patients described 332 self-care practices, resulting in 14 different categories of self-care strategies. The 5 most common indicators of practicing self-care were fatigue, general wellbeing, psychological symptoms, nausea, vomiting and improving physical condition. The 5 most common self-care strategies were physical activity, increased recovery, healthy eating, distraction, and skincare. Patients who were married, were older than 69, patients with less education than university education, patients undergoing a combination of internal and external radiotherapy, patients experiencing fewer than 8 symptoms, and better quality of life, practiced self-care to a lower extent than did other patients. Functional capacity did not differ between self-care practitioners and non-practitioners. Conclusion and Implications for Practice: Of the patients undergoing radiotherapy, slightly less than half practiced self-care during an ordinary week of radiotherapy. Because older and less-educated patients were less likely to practice self-care, cancer care practitioners should consider paying particular attention to helping such patients with their self-care practice. [ABSTRACT FROM AUTHOR]

Placebo research has established the pivotal role of treatment expectations in shaping symptom experience and patient-reported treatment outcomes. Perceived treatment efficacy constitutes a relevant yet understudied aspect, especially in the context of the gut-brain axis with visceral pain as key symptom. Using a clinically relevant experimental model of visceral pain, we elucidated effects of pre-treatment expectations on post-treatment perceived treatment efficacy as an indicator of treatment satisfaction in a translational placebo intervention. We implemented positive suggestions regarding intravenous treatment with a spasmolytic drug (in reality saline), herein applied in combination with two series of individually calibrated rectal distensions in healthy volunteers. The first series used distension pressures inducing pain (pain phase). In the second series, pressures were surreptitiously reduced, modeling pain relief (pain relief phase). Using visual analog scales (VAS), expected and perceived treatment efficacy were assessed, along with perceived pain intensity. Manipulation checks supported that the induction of positive pre-treatment expectations and the modeling of pain relief were successful. Generalized Linear Models (GLM) were implemented to assess the role of inter-individual variability in positive pre-treatment expectations in perceived treatment efficacy and pain perception. GLM indicated no association between pre-treatment expectations and perceived treatment efficacy or perceived pain for the pain phase. For the relief phase, pre-treatment expectations (p = 0.024) as well as efficacy ratings assessed after the preceding pain phase (p < 0.001) were significantly associated with treatment efficacy assessed after the relief phase, together explaining 54% of the variance in perceived treatment efficacy. The association between pre-treatment expectations and perceived pain approached significance (p = 0.057) in the relief phase. Our data from an experimental translational placebo intervention in visceral pain support that reported post-treatment medication efficacy is shaped by pre-treatment expectations. The observation that individuals with higher positive expectations reported less pain and higher treatment satisfaction after pain relief may provide first evidence that perceived symptom improvement may facilitate treatment satisfaction. The immediate experience of symptoms within a given psychosocial treatment context may dynamically change perceptions about treatment, with implications for treatment satisfaction, compliance and adherence of patients with conditions of the gut-brain axis.

Objectives: Fears of compassion are hypothesized to be associated with treatment attitudes, but this relationship has not yet been explored. Methods: Measures of fear of compassion and treatment expectations and ambivalence were administered to those with above‐average anxiety (N = 302) and those who met criteria for an anxiety or related disorder (N = 40). Results: In those with anxiety disorders, fear of receiving compassion and fear of self‐compassion were strongly correlated with treatment ambivalence. In both samples, higher fear of receiving compassion was associated with more negative expectations for treatment. Conclusions: Fear of compassion is associated with treatment ambivalence and treatment expectations and may be an important target early in treatment. Practitioner Points: Fears of receiving compassion and self‐compassion were related to treatment ambivalence and negative treatment expectationsThere may be benefit in targeting fear of compassion early in treatment [ABSTRACT FROM AUTHOR]

Background: Recent research suggests that a significant number of those who receive advanced treatments for Parkinson's disease (PD) do not report improvements for some symptoms, which may relate to their pre-treatment expectations. It is important that expectations of treatment are measured and discussed prior to advanced treatment. Objective: The primary aim of this study was to develop a measure of treatment expectations of two advanced-stage treatments in PD, deep brain stimulation (DBS), and Levodopa/Carbidopa Intestinal Gel (LCIG). A secondary aim was to explore potential predictors of treatment expectations. Methods: The questionnaire-based measure was developed by researchers in conjunction with a highly experienced clinician, and evaluated treatment expectations in 189 people aged 46–91 years (M = 71.35, SD = 8.73; 61% male) with idiopathic PD. Results: The overall measure demonstrated excellent internal consistency (α= 0.96). Exploratory factor analysis suggested the scale was unidimensional for both DBS and LCIG. Participant expectations of the two treatments differed significantly, with expectations being higher for DBS. Perceived symptom severity was the strongest predictor of treatment expectations. Conclusion: This scale has potential to inform clinicians about client expectations prior to advanced stage therapy for PD, with a view to the management of these expectations. Further evaluation of the scale is required across different treatment contexts. [ABSTRACT FROM AUTHOR]

Lea Schemer,1 Winfried Rief,2 Julia A Glombiewski1 1Department of Clinical Psychology and Psychotherapy, University Koblenz - Landau, Landau 76829, Germany; 2Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Marburg 35032, GermanyCorrespondence: Lea SchemerDepartment of Clinical Psychology and Psychotherapy, University Koblenz – Landau, Ostbahnstraße 10, Landau 76829, GermanyTel +49 6341 280-35627Email schemer@uni-landau.dePurpose: Accumulating evidence suggests an association between patient expectations and treatment success across various types of pain treatments. Expectations among treatment caregivers, however, are often neglected. Despite international treatment guidelines, only a small minority of chronic pain patients undergo psychological interventions. Therefore, our aim was to explore expectations among treatment receivers and caregivers especially concerning their attitudes towards psychological pain treatments.Methods: Two hundred ten (potential) treatment receivers (n=85 individuals suffering from chronic low back pain (CLBP); n=125 healthy controls) and 237 caregivers (n=75 physicians; n=64 psychotherapists; n=98 physiotherapists) provided ratings of expected treatment success for standardized vignettes describing patients suffering from CLBP and undergoing a pharmacological, psychological, or multimodal pain management program.Results: Individuals suffering from CLBP generally had lower treatment expectations than healthy controls. Both psychotherapists and physicians had higher treatment expectations from their own individual treatment approach. All participants expected the multimodal approach to be most effective. The psychological approach was expected to be more effective than the pharmacological approach – except for the physicians, who expected both treatment approaches to be equally effective.Conclusion: There is an urgent need to clarify, under which circumstances and how patient expectations can be altered among individuals suffering from CLBP. Our results appear to encourage the implementation of multimodal and psychological pain management approaches across various settings. We invite clinicians to reflect whether their own expectations are in line with the recommendations in international treatment guidelines.Keywords: treatment expectations, chronic pain management approaches, psychological pain treatments, attitudes of treatment receivers and caregivers

Abstract Background Metastatic prostate cancer is incurable, but systemic therapies can improve quality of life and prolong survival. Accurate perceptions of treatment risks and benefits are vital as patients with metastatic disease make treatment decisions. We assessed treatment‐related expectations for benefit among patients with metastatic prostate cancer and explored associated sociodemographic characteristics. Methods Men with metastatic prostate cancer (N = 100) completed surveys assessing their treatment‐related expectations for cancer cure, symptom relief, and prolonged life expectancy. Frequencies were used to describe the proportions of reported expectations. Fisher's exact tests were used to assess the associations of sociodemographic characteristics with treatment expectations. Results One third (33%) of participants believed treatment was at least a little likely to cure their metastatic cancer. Most participants believed treatment could provide symptom relief (76%) and extend life expectancy (95%). Among participants reporting that cancer cure was at least a little likely vs not at all, more men identified as non‐white (24% vs 5%; P = .01), self‐reported good health (90% vs 58%; P

Abstract Introduction The goal of psoriasis (PsO) treatment is to improve quality of life by lessening the extent and severity of the disease. Traditional systemic drugs and biologic agents are used for the treatment of moderate to severe PsO and recent research emphasizes understanding patient goals and preferences for treatment, to improve overall outcomes. Methods An online survey was administered to collect data from 500 adult patients with moderate to severe PsO in the USA. Patients were required to have current or previous systemic therapy use and were excluded if aged 75 or older. Data on demographics, disease burden, treatment use, and patients’ treatment goals and expectations were collected. Descriptive and multivariate analyses examined the factors that predict treatment goals. Subgroup analyses were performed for age, gender, severity, comorbid psoriatic arthritis (PsA), location of PsO, and biologic experience. All analyses were conducted using SAS v9.4 and R v3.4. Results Of the 500 adult patients included, 71.6% reported moderate PsO. Patients had a mean (SD) score of 62.4 (23.0) for skin pain, 60.0 (26.3) for fatigue, and 6.6 (2.1) for itch on a scale of 0–100, 0–100, and 0–10 respectively. Mean (SD) score for quality of life (QoL), assessed using Dermatology Life Quality Index (DLQI), was 18.3 (7.3), with more than 90% having moderate/very large/extremely large effect on life. The majority of patients considered “keeping skin clear for 2–3 years” (94%), “overall relief of symptoms” (93.8%), and effective in clearing certain areas” (92.2%) as important attributes of a systemic treatment. Overall, patients expected 50% clear skin in about 2 weeks and completely clear skin in about 4 weeks. Conclusions Overall, in this study with more than 70% of patients with moderate disease, patients reported high burden of disease and impact on QoL. This study demonstrates the importance of considering patient perspectives in treatment decisions that are critical for optimizing patient outcomes. Funding Eli Lilly and Company.

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.

Background and purpose: This was an investigation of treatment expectations and of the perception of therapy in adult patients with 5q‐associated spinal muscular atrophy (5q‐SMA) receiving nusinersen. Methods: A prospective, non‐interventional observational study of nusinersen treatment in adult 5q‐SMA patients was conducted at nine SMA centers in Germany. The functional status, treatment expectations and perceived outcomes were assessed using the Amyotrophic Lateral Sclerosis Functional Rating Scale—extended (ALS‐FRS‐ex), the Measure Yourself Medical Outcome Profile (MYMOP2), the Treatment Satisfaction Questionnaire for Medication (TSQM‐9) and the Net Promoter Score (NPS). Results: In all, 151 patients were included with a median age of 36 years (15–69 years). SMA type 3 (n = 90, 59.6%) prevailed, followed by type 2 (33.8%) and type 1 (6.6%). In SMA types 1–3, median ALS‐FRS‐ex scores were 25, 33 and 46 (of 60 scale points), respectively. MYMOP2 identified distinct treatment expectations: head verticalization (n = 13), bulbar function (n = 16), arm function (n = 65), respiration (n = 15), trunk function (n = 34), leg function (n = 76) and generalized symptoms (n = 77). Median symptom severity decreased during nusinersen treatment (median observational period 6.1 months, 0.5–16 months) from 3.7 to 3.3 MYMOP2 score points (p < 0.001). The convenience of drug administration was critical (49.7 of 100 TSQM‐9 points, SD 22); however, the overall treatment satisfaction was high (74.3, SD 18) and the recommendation rating very positive (NPS +66). Conclusions: Nusinersen was administered across a broad range of ages, disease durations and motor function deficits. Treatment expectations were highly differentiated and related to SMA type and functional status. Patient‐reported outcomes demonstrated a positive perception of nusinersen therapy in adult patients with 5q‐SMA. [ABSTRACT FROM AUTHOR]

Treatment expectations reportedly shape treatment outcomes, but have not been studied in the context of multimodal therapy in Crohn's disease (CD). Therefore, the current study investigated the role of treatment expectations for subjective symptom changes in CD patients who have undergone an integrative multimodal therapy program. Validated questionnaires were completed at the start of the treatment program and post intervention. Pre-treatment expectations and experienced symptom change were assessed with the Generic Rating Scale for Previous Treatment Experiences, Treatment Expectations, and Treatment Effects (GEEE); stress levels were quantified with the Perceived Stress Scale (PSS-10) and disease specific quality of life was quantified with the disease-specific Inflammatory Bowel Disease Questionnaire (IBDQ). We performed multiple linear and Bayesian regression to determine how expectations related to symptom change. N = 71 CD patients (66.2% female) were included. Stronger expectations regarding symptom improvement (b = 0.422, t = 3.70, p <.001) were associated with higher experienced symptom improvement. Additionally, Bayesian analysis provided strong evidence for including improvement expectations as a predictor of improvement experience (BF inclusion = 13.78). In line with research in other disorders, we found that positive treatment expectations were associated with experienced symptom improvement. In contrast, we found no indication that an experience of symptom worsening was associated with positive or negative baseline treatment expectations. Induction of positive expectations might be a potential avenue for improving treatment outcomes in CD therapy. • Positive expectations predict experienced improvement in Crohn's Disease symptoms. • Negative expectations were not associated with negative symptom changes. • Induction of positive expectations might facilitate Crohn's Disease treatment. [ABSTRACT FROM AUTHOR]

Background: Expectations may modify outcomes. However, studies often fail to measure expectations. This raises the need for a brief valid and reliable expectancy measure., Objectives: To study treatment expectations in individuals entering acupuncture or rest, validity and test re-test reliability of a single-item expectancy measure graded on a category scale, a Numeric Rating Scale (NRS) and a Visual Analog Scale (VAS), and to identify psychometric differences between the scales., Method: In this methodology study, treatment expectations were measured in 363 participants before they received acupuncture (genuine traditional penetrating or non-penetrating telescopic sham acupuncture, n = 239, 98%, responded) or a control treatment involving just rest (n = 120, 100%, responded), aimed to improve level of relaxation. A treatment expectancy measure, graded on a five-grade category scale, an eight-grade NRS and a 100 mm VAS, was tested for test re-test reliability. Level of expectation and relaxation was measured at baseline, pre- and post-therapy (n = 729 expectancy measurements)., Results: The participants scheduled for acupuncture or rest believed moderately (Inter Quartile Range, IQR, moderately-much) and much (IQR moderately-much) the treatment to be effective. The Intra-Class Correlation coefficient versus Kappa coefficient between test and re-test was .868/.868 for the category scale, .820/.820 for the NRS, and .856/.854 for the VAS. The middle step "Believe moderately the treatment to be effective" was equivalent with median 4 (IQR, 3-4) on NRS and median 52 mm (IQR 42-52) on VAS. The response rates were 708 (97%) on the category scale, 707 (97%) on the NRS, and 703 (96%) on the VAS. All three scales discriminated that pre-therapy expectations were more positive in the individuals who reported an improvement in relaxation level ( P < .001-.003). The VAS presented higher responsiveness to detect expectancy changes over time (71% increased expectation), compared to the NRS (52% increased) and the category scale (12% increased), P < .001., Conclusions: Individuals entering acupuncture, or a control intervention, presented positive treatment expectations, and the expectancy measure presented satisfactory reliability, validity, high response rates, sensitiveness, and responsiveness. Integrative cancer therapy researchers who want to control for expectancy-related bias in clinical trials should consider measuring expectation using the single-item expectancy measure., Competing Interests: Declaration of Conflicting InterestsThe author declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Abstract Background Accurate patient expectations are important to optimise treatment success, especially for complex conditions such as chronic pain. Communication may be the key to managing patient expectations. This study aimed to explore whether health care provider communication influences patient expectations and which communication aspects are most important. Methods We conducted secondary analyses on data that had been collected between September and November 2012. 2603 patients suffering from chronic pain were invited to complete a survey. Results Although 69.9% of patients achieved or surpassed their treatment goal, 30.2% of patients were unsatisfied. Even though overall health care provider communication and shared decision making were unrelated to patient expectations, several affective communication aspects were related. These aspects were attentive listening, taking enough time, building patient’s trust in the physician’s competence and giving patients the feeling that the physician is doing all he or she can (p’s

Abstract Background Patients undergoing chemotherapy are highly burdened by side effects. These may be caused by the pharmacodynamics of the drug or be driven by psychological factors such as negative expectations or pre-conditioning, which reflect nocebo effects. As such, negative pre-treatment expectations or prior experiences might exacerbate the burden of chemotherapy side effects. Educating patients about this nocebo effect has been put forward as a potential strategy to optimize patients’ pre-treatment expectations. In this study, we evaluate whether a briefing about the nocebo effect is efficacious in reducing side effects. Methods In this exploratory study, a total number of n = 100 outpatients with newly diagnosed gastrointestinal cancers are randomized 1:1 to an information session about the nocebo effect (nocebo-education) or an attention control group (ACG) with matching interaction time. Assessments take place before the intervention (T1 pre), post-intervention (T1 post), and 10 days (T2) and 12 weeks (T3) after the initial chemotherapy. The primary outcomes are the patient-rated number and intensity of side effects at 10-days and at 12-weeks follow-up. Secondary outcomes include coping with side effects, tendency to misattribute symptoms, compliance intention, attitude towards the chemotherapy, co-medication to treat side effects and the clinician-rated severity of toxicity. Further analyses are conducted to investigate whether a potential beneficial effect is mediated by a change of expectations before and after the intervention. Discussion Informing patients about the nocebo effect might be an innovative and feasible intervention to reduce the burden of side effects and strengthen patients’ perceived control over adverse symptoms. Trial registration The trial is registered at the German Clinical Trials Register (ID: DRKS00009501; retrospectively registered on March 27, 2018). The first patient was enrolled on September 29, 2015.

Background: It is common practice to inform patients about causes and treatment models when starting psychiatric treatment or psychotherapy for schizophrenia. However, previous research indicates that focusing on etiological models increases stigmatizing beliefs. This raises the question of whether contemporary, medical or cognitive behavioral therapy (CBT)-based treatment models share this negative side effect. Aim: This experiment tested whether providing information about medical vs. CBT-based vs. combined treatment models affects stigmatizing attitudes towards schizophrenia and the expected efficacy of these treatments. Methods: Participants received a case vignette of a person with schizophrenia including either: (1) no treatment details, or a description of treatment with (2) medication, (3) CBT, or (4) medication and CBT. Next, stigmatizing attitudes (stereotypes, affective reactions, and desired social distance) were assessed and participants rated the perceived effectiveness of different treatment methods. Results: No treatment model showed an effect on stigmatizing attitudes. Medical and CBT treatment information (alone or in combination) had a positive effect on subjective efficacy ratings for the respective treatment. Conclusion: There appear to be no negative side effects of (biogenetic) models when presented in a context emphasizing recovery. Moreover, medication and CBT treatment information showed additive positive effects on the rating of treatment strategies. A combined treatment model integrating various evidence-based methods appears to be most useful in clinical practice. [ABSTRACT FROM AUTHOR]

In the past few decades, research on pain and placebo analgesia has gained importance both scientifically and clinically. In this article, the current findings and focus of research as well as the significance of placebo research for assessing the effectiveness of pain medication are illustrated. The underlying mechanisms of placebo analgesia not only have implications for theoretical models but also offer clinically relevant guidelines for everyday interventions in pain treatment. However, many placebo phenomena are not fully understood and have to be investigated further in order to exploit the full potential of placebo effects. Interindividual differences and their inclusion in treatment will play a major role in this aspect. [ABSTRACT FROM AUTHOR]

Psychotherapists may offer patients more or less involvement when deciding on a treatment. The aim of the present research was to examine whether perceptions of the treatment and therapist differ when a therapist uses a paternalistic style in making treatment decisions or a more collaborative approach, in which the patient helps in selecting treatment. In the study, 172 participants, recruited from a university setting and a national sample, listened to a simulated conversation representing either a paternalism or informed-choice model of a therapist-patient interaction. The participants then rated their expectation the treatment would help the patient, their perception of the therapist's trustworthiness, and their own preference for relying on clinicians for knowledge and decisions. Analysis indicated that among participants preferring to rely on clinicians, perceptions did not differ reliably based on the type of interaction they heard. However, participants wanting more involvement in treatment choices perceived greater treatment effectiveness and clinician trustworthiness for the interaction in which the patient was offered treatment choices. These results suggest that if therapists adopt a collaborative approach, it has the potential to enhance perceptions of individuals preferring the collaborative style without negatively affecting those who prefer less involvement in treatment decisions. [ABSTRACT FROM AUTHOR]

Background: Metastatic prostate cancer is incurable, but systemic therapies can improve quality of life and prolong survival. Accurate perceptions of treatment risks and benefits are vital as patients with metastatic disease make treatment decisions. We assessed treatment‐related expectations for benefit among patients with metastatic prostate cancer and explored associated sociodemographic characteristics. Methods: Men with metastatic prostate cancer (N = 100) completed surveys assessing their treatment‐related expectations for cancer cure, symptom relief, and prolonged life expectancy. Frequencies were used to describe the proportions of reported expectations. Fisher's exact tests were used to assess the associations of sociodemographic characteristics with treatment expectations. Results: One third (33%) of participants believed treatment was at least a little likely to cure their metastatic cancer. Most participants believed treatment could provide symptom relief (76%) and extend life expectancy (95%). Among participants reporting that cancer cure was at least a little likely vs not at all, more men identified as non‐white (24% vs 5%; P =.01), self‐reported good health (90% vs 58%; P <.01), and had greater optimism (78% vs 47%; P <.01). Among participants reporting that symptom relief was at least a little likely vs not at all, more men were less than 70 years old (62% vs 0%; P =.01). Conclusion: A large proportion of patients with metastatic prostate cancer reported beliefs inconsistent with understanding that treatment was not curative. Race, better self‐reported health, and greater optimism were related to unrealistic expectations. Efforts to ensure alignment of patient and clinician expectations may facilitate more effective shared decision‐making for treating metastatic disease. [ABSTRACT FROM AUTHOR]

Introduction: The goal of psoriasis (PsO) treatment is to improve quality of life by lessening the extent and severity of the disease. Traditional systemic drugs and biologic agents are used for the treatment of moderate to severe PsO and recent research emphasizes understanding patient goals and preferences for treatment, to improve overall outcomes. Methods: An online survey was administered to collect data from 500 adult patients with moderate to severe PsO in the USA. Patients were required to have current or previous systemic therapy use and were excluded if aged 75 or older. Data on demographics, disease burden, treatment use, and patients' treatment goals and expectations were collected. Descriptive and multivariate analyses examined the factors that predict treatment goals. Subgroup analyses were performed for age, gender, severity, comorbid psoriatic arthritis (PsA), location of PsO, and biologic experience. All analyses were conducted using SAS v9.4 and R v3.4. Results: Of the 500 adult patients included, 71.6% reported moderate PsO. Patients had a mean (SD) score of 62.4 (23.0) for skin pain, 60.0 (26.3) for fatigue, and 6.6 (2.1) for itch on a scale of 0–100, 0–100, and 0–10 respectively. Mean (SD) score for quality of life (QoL), assessed using Dermatology Life Quality Index (DLQI), was 18.3 (7.3), with more than 90% having moderate/very large/extremely large effect on life. The majority of patients considered "keeping skin clear for 2–3 years" (94%), "overall relief of symptoms" (93.8%), and effective in clearing certain areas" (92.2%) as important attributes of a systemic treatment. Overall, patients expected 50% clear skin in about 2 weeks and completely clear skin in about 4 weeks. Conclusions: Overall, in this study with more than 70% of patients with moderate disease, patients reported high burden of disease and impact on QoL. This study demonstrates the importance of considering patient perspectives in treatment decisions that are critical for optimizing patient outcomes. Funding: Eli Lilly and Company. [ABSTRACT FROM AUTHOR]