Oncologist recommendation matters!-Predictors of psycho-oncological service uptake in oncology outpatients.

OBJECTIVE: Highly distressed cancer patients often do not use psycho-oncological services (POS). Research on predictors of POS uptake has mainly focused on patient-related variables and less on communication variables, so we examined the link between patient-oncologist communication (ie, talking about psychosocial distress, providing detailed information, and recommending POS) and POS uptake. METHODS: We conducted a prospective, observational study in an Oncology Outpatient Clinic in Switzerland. Predictors (ie, patient-related variables and patient's reports of the patient-oncologist communication) were assessed via semistructured interviews, and information on outpatient POS uptake was assessed after 4 months. For statistical analysis, a multivariate logistic regression was performed. RESULTS: Of 333 participants (mean age 61 years; 55% male; 54% distress thermometer ≥5), 77 (23%) had used POS during a 4-month period. Patients who reported an oncologist-recommended POS (odds ratio [OR] = 6.27, 95% confidence interval [CI] = 3.14-12.85) and those who were not sure if they had received a recommendation (OR = 4.64, 95% CI = 1.83-11.97) were more likely to attend POS than those who reported receiving no recommendation. Talking about psychosocial distress (OR = 0.74, 95% CI = 0.38-1.46) and providing detailed information about POS did not predict POS uptake (OR = 1.06, 95% CI = 0.46-2.38). CONCLUSIONS: Oncologists' expert recommendations to attend POS were strongly associated with patients' uptake of POS. The central role played by oncologists should be accounted for in stepped psycho-oncological care when POS referral pathways are defined.

Lay perspectives of the open-label placebo rationale: a qualitative study of participants in an experimental trial.

OBJECTIVES: To analyse participants' concepts about the open-label placebo (OLP) effect; to explore their views about the discussion points that are applied in conventional OLP trials and to examine their experiences of taking part in an OLP trial. DESIGN: A qualitative study using thematic analysis of semistructured interviews that were nested within a randomised controlled trial investigating experimental OLP analgesia (registered at ClinicalTrials.gov: NCT02578420). PARTICIPANTS: 30 healthy adults who took part in the randomised controlled trial. RESULTS: Participants mostly conceptualised placebo as something that is inert and requires deception in order to be effective. Interviewees used a broad definition of placebos, going beyond a conventional notion of sugar pills. In contrast to the conventional OLP rationale, participants seldom emphasised classical conditioning as a mechanism of placebo effects, stressing a variety of other well-established components through which placebos might be therapeutic, whereas the conventional OLP disclosures state that 'a positive attitude helps but is not necessary', participants in our study applied other attitudes, such as 'it's worth a try'. When asked about their experiences during the trial, the majority emphasised that the concept of OLP was completely novel to them. Participants were rather sceptical about the efficacy of the intervention. CONCLUSION: Integrating lay perspectives into the scientific rationale of OLP treatments might enhance the plausibility and credibility of the rationale in ethical treatments. TRIAL REGISTRATION NUMBER: NCT02578420.

Open-label placebo treatment of women with premenstrual syndrome: study protocol of a randomised controlled trial.

INTRODUCTION: Recent evidence suggests that for certain clinical conditions, placebos can improve clinical outcomes even without deception. These so-called open-label placebos (OLPs) bear the advantage of a significant lower risk of adverse events and comply with ethical principles. Although premenstrual syndrome (PMS) seems to be considerably susceptible to placebo effects, no study has examined open-OLP responses on PMS. METHODS AND ANALYSIS: To test the efficacy of OLPs in women suffering from PMS, a clinical randomised controlled trial including two OLP study groups (with and without treatment rationale) was designed to investigate on the effect on PMS. PMS symptoms are monitored on a daily basis via a symptom diary, adverse events are monitored intermittently. The study started in spring 2018 and patients will be included until a maximum of 150 participants are randomised. Besides the primary outcome PMS symptom intensity and interference, an array of further variables is assessed. Multilevel modelling will be used for data analyses. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Ethics Committee Northwest and Central Switzerland. Results of the main analysis and of secondary analyses will be submitted for publication in peer-reviewed journals. TRIAL REGISTRATION NUMBERS: (1) ClinicalTrials.gov (NCT03547661); (2) Swiss national registration (SNCTP000002809).

Open-label placebo response - Does optimism matter? A secondary-analysis of a randomized controlled trial.

OBJECTIVE: Open-label placebos (OLPs) have been found to elicit significant and clinical meaningful effects, but in comparison to deceptive placebo administration there is a lack of research regarding possible predictors. This study sets out to examine the effects of optimism and other personality-related variables on OLP responses. METHODS: We conducted a secondary-analysis of an OLP trial in healthy participants (N = 160), who were randomized to no treatment (NT), OLP without rationale (OPR-), OLP with rationale (OPR+), and deceptive placebo (DP) in an experimental heat pain paradigm. RESULTS: The association between objective posttreatment pain tolerance and optimism did not differ among groups. However, for subjective heat pain ratings at posttreatment, regression analyses showed a significant interaction between group and optimism scores in subjective intensity (F[3, 142] = 3.81, P = 0.012) and unpleasantness ratings (F[3, 142] = 2.95, P = 0.035), indicating that the association between optimism and subjective ratings differed among groups, in particular between OPR+ and NT (intensity: P = 0.012; unpleasantness: P = 0.037), and OPR+ and DP (intensity: P = 0.016). Thus, higher optimism scores were negatively associated with subjective ratings in the NT and DP groups but not in the OPR+ group. Additional exploratory analyses revealed no significant interactions between group and further personality-related variables on heat pain analgesia. CONCLUSION: Taken together, OLPs are effective, the underlying personality-related variables seem, however, to differ significantly from the deceptive placebo response. Therefore, the concept of "placebo responders" might depend on the route of placebo administration.

Is the rationale more important than deception? A randomized controlled trial of open-label placebo analgesia.

Research on open-label placebos questions whether deception is a necessary characteristic of placebo effects. Yet, comparisons between open-label and deceptive placebos (DPs) are lacking. We therefore assessed effects of open-label placebos and DPs in comparison with no treatment (NT) with a standardized experimental heat pain paradigm in a randomized controlled trial in healthy participants. Participants (N = 160) were randomly assigned to NT, open-label placebo without rationale (OPR-), open-label placebo with rationale (OPR), and DP. We conducted baseline and posttreatment measurements of heat pain threshold and tolerance. Apart from the NT, all groups received an application of a placebo cream. Primary outcomes were planned comparisons of heat pain tolerance and the corresponding intensity and unpleasantness ratings. Objective posttreatment pain tolerance did not differ among groups. However, for subjective heat pain ratings at the posttreatment tolerance level, groups with a rationale (OPR and DP) reported diminished heat pain intensity (t(146) = -2.15, P = 0.033, d = 0.43) and unpleasantness ratings (t(146) = -2.43, P = 0.016, d = 0.49) compared with the OPR-group. Interestingly, the OPR and the DP groups did not significantly differ in heat pain intensity (t(146) = -1.10, P = 0.272) or unpleasantness ratings (t(146) = -0.05, P = 0.961) at the posttreatment tolerance level. Our findings reveal that placebos with a plausible rationale are more effective than without a rationale. Even more, open-label placebos did not significantly differ in their effects from DPs. Therefore, we question the ubiquitously assumed necessity of concealment in placebo administration.