Optimizing placebo and minimizing nocebo effects through communication: e-learning and virtual reality training development.

BACKGROUND: The effects of many treatments in healthcare are determined by factors other than the treatment itself. Patients' expectations and the relationship with their healthcare provider can significantly affect treatment outcomes and thereby play a major role in eliciting placebo and nocebo effects. We aim to develop and evaluate an innovative communication training, consisting of an e-learning and virtual reality (VR) training, for healthcare providers across all disciplines, to optimize placebo and minimize nocebo effects through healthcare provider-patient communication. The current paper describes the development, mid-term evaluation, optimization, and final evaluation of the communication training, conducted in The Netherlands. METHODS: The development of both the e-learning and the VR training consisted of four phases: 1) content and technical development, 2) mid-term evaluation by healthcare providers and placebo/communication researchers, 3) optimization of the training, and 4) final evaluation by healthcare providers. To ensure the success, applicability, authenticity, and user-friendliness of the communication training, there was ongoing structural collaboration with healthcare providers as future end users, experts in the field of placebo/communication research, and educational experts in all phases. RESULTS: Placebo/communication researchers and healthcare providers evaluated the e-learning positively (overall 7.9 on 0-10 scale) and the content was perceived as useful, accessible, and interesting. The VR training was assessed with an overall 6.9 (0-10 scale) and was evaluated as user-friendly and a safe method for practicing communication skills. Although there were some concerns regarding the authenticity of the VR training (i.e. to what extent the virtual patient reacts like a real patient), placebo and communication researchers, as well as healthcare providers, recognized the significant potential of the VR training for the future. CONCLUSIONS: We have developed an innovative and user-friendly communication training, consisting of an e-learning and VR training (2D and 3D), that can be used to teach healthcare providers how to optimize placebo effects and minimize nocebo effects through healthcare provider-patient communication. Future studies can work on improved authenticity, translate the training into other languages and cultures, expand with additional VR cases, and measure the expected effects on providers communication skills and subsequently patient outcomes.

Shared decision-making performance of general practice residents: an observational study combining observer, resident, and patient perspectives.

BACKGROUND: Shared decision making (SDM) is considered fundamental to person-centred care. However, applying SDM may be a challenge for residents in general practice, since it is a complex competence that requires the integration of knowledge and skills from several competency domains. OBJECTIVE: To support learning of SDM during medical residency, we aimed to gain insight in Dutch residents' observed and perceived SDM performance in general practice. METHODS: We evaluated residents' SDM performance from an observer, resident, and patient perspective. Consultations of first- and third-year residents were recorded. Trained observers used the validated Observing Patient Involvement (OPTION5) scale to assess observed SDM performance of residents in 98 actual recorded consultations. Perceived SDM performance was evaluated by residents and patients completing validated SDM questionnaires, supplemented with questions about (the context of) the consultation and perceived relevance of SDM immediately after the consultation. The data were analysed using descriptive statistics (mean, SD, minimums, and maximums) and explorative bivariate analyses. RESULTS: The residents' observed mean SDM performance was 19.1 (range, 0-100, SD = 10.9), mean resident self-reported SDM performance was 56.9 (range, 0-100, SD = 18.5), and mean patient-reported SDM performance was 73.3 (range, 0-100, SD = 26.8). We found a significant and positive correlation between observed SDM performance and residents' perceived relevance of SDM for the consultation (t = 4.571, P ≤ 0.001) and the duration of the consultation (r = 0.390, P ≤ 0.001). CONCLUSIONS: This study showed that there is room for increasing awareness of the potential incongruence between observed and perceived SDM performance during medical residency, in order to facilitate the implementation of SDM in clinical practice.

THE PROBLEM: Shared decision making is an important process in which healthcare professional and patient work together to reach a decision on how to solve a health problem. This decision should include patients' needs and what matters most to them. We investigated if consultations between general practitioners in training (i.e. residents) and their patients demonstrate shared decision making. The research methods: We asked the residents and patients to respond to questions on their experience of shared decision making right after the consultation. We recorded 98 consultations of residents with their patients. Two researchers rated to what extent residents demonstrated shared decision-making behaviours during these consultations. THE RESULTS: The patients reported more shared decision making than the residents (patients: 73 versus residents: 57 on a 0­100 scale). The researchers observed low levels of SDM during the consultations (19 on a 0­100 scale). Our conclusion: Residents should be aware that shared decision making does not yet frequently occur in practice. To improve the extent to which residents share decisions with their patients in general practice, residents should learn why, when, and how to involve patients in decision making during consultations.

The effect of shared decision-making on recovery from non-chronic aspecific low back pain in primary care; a post-hoc analysis from the patient, physician and observer perspectives.

BACKGROUND: Although shared decision-making (SDM) is increasingly accepted in healthcare and has demonstrated merits for several psychological outcomes, the effect on recovery from somatic conditions is still subject to debate. The objective of this study is to measure the effect of SDM on recovery from non-chronic aspecific low back pain (LBP). METHODS: This study is a post-hoc analysis of data from a cluster-randomised trial that evaluated the effectiveness of SDM on recovery in patients with non-chronic aspecific LBP. In this analysis, we re-evaluate the impact of SDM from three perspectives: that of external observers, participating GPs and participating patients. Recovery was measured with the Visual Analogue Scale (VAS) for pain and with the Roland Morris Disability questionnaire (RMD) and defined as a VAS < 30 and an RMD < 4. Logistic regression was used to analyse the effect of SDM on recovery at 6 and 26 weeks. RESULTS: At 26 weeks, 105 (74%) of all 176 included patients had recovered. No significant effect of SDM on recovery at 6 or 26 weeks after the consultation was found when considering SDM from an observer perspective or a patient perspective. From a GP perspective SDM had a significant effect on recovery, but at 26 weeks only, and with the lowest probability of recovery observed at a medium level of GP-perceived SDM. CONCLUSIONS: We found no evidence that SDM as perceived by the patient or by external observation improves recovery from non-chronic aspecific low back pain. The long-term recovery may be better for patients in whom the GP perceives SDM during their consultations. Further research should highlight the hierarchy and the relation between the perspectives, which is needed to come to an integral effect evaluation of SDM. TRIAL REGISTRATION: The Netherlands National Trial Register (NTR) number: NTR1960 .

The effectiveness of shared decision-making followed by positive reinforcement on physical disability in the long-term follow-up of patients with nonspecific low back pain in primary care: a clustered randomised controlled trial.

BACKGROUND: Although the recovery of patients suffering from low back pain is highly context dependent, patient preferences about treatment options are seldom incorporated into the therapeutic plan. Shared decision-making (SDM) offers a tool to overcome this deficiency. The reinforcement by the general practitioner (GP) of a 'shared' chosen therapy might increase patients' expectations of favourable outcomes and thus contribute to recovery. METHODS: In the Netherlands, a clustered randomised controlled trial was performed to assess the effectiveness of shared decision-making followed by positive reinforcement of the chosen therapy (SDM&PR) on patient-related clinical outcomes. Overall, 68 GPs included 226 patients visiting their GP for a new episode of non-chronic low back pain. GPs in the intervention group were trained in implementing SDM&PR using a structured training programme with a focus on patient preferences in reaching treatment decisions. GPs in the control group provided care as usual. The primary outcome was the change in physical disability measured with the Roland-Morris disability questionnaire (RMD) during the six-month follow-up after the first consultation. Physical disability (RMD), pain, adequate relief, absenteeism and healthcare consumption at 2, 6, 12 and 26 weeks were secondary outcomes. A multivariate analysis with a mixed model was used to estimate the differences in outcomes. RESULTS: Of the patients in the intervention and the control groups, 66 and 62%, respectively, completed the follow-up. Most patients (77%) recovered to no functional restrictions due to back pain within 26 weeks. No significant differences in the mean scores for any outcome were observed between intervention patients and controls during the follow-up, and in multivariate analysis, there was no significant difference in the main outcome during the six-month follow-up. Patients in the intervention group reported more involvement in decision-making. CONCLUSION: This study did not detect any improvement in clinical outcome or in health care consumption of patients with non-chronic low back pain after the training of GPs in SDM&PR. The implementation of SDM merely introduces task-oriented communication. The training of the GPs may have been more effective if it had focused more on patient-oriented communication techniques and on stressing the expectation of favourable outcomes. TRIAL REGISTRATION: The Netherlands National Trial Register (NTR) number: NTR1960. The trial was registered in the NTR on August 20, 2009.

Effects of improved patient participation in primary care on health-related outcomes: a systematic review.

BACKGROUND: In primary care, many consultations address symptom-based complaints. Recovery from these complaints seldom exceeds placebo effects. Patient participation, because of its supposed effects on trust and patient expectancies, is assumed to benefit patients' recovery. While the idea is theoretically promising, it is still unclear what the effects of increased patient participation are on patient outcomes. Aim. To review the effects of controlled intervention studies aiming to improve patient participation in face-to-face primary care consultations on patient-oriented and/or disease-oriented outcomes. METHODS: This study is a systematic review. A systematic search was undertaken for randomized controlled trials designed to measure the effects of interventions that aimed to improve adult patients' participation in primary care visits. The CINAHL, Cochrane, EMBASE, PsycINFO and PubMed databases were searched. RESULTS: Seven different trials fulfilled the inclusion criteria. Three of the studies were related to symptom-based complaints. Five studies measured patient-oriented outcomes, the primary outcome of interest for this review. All studies suffered from substantial bias. Studies varied widely in their aims, types of complaints/diseases, strength of the interventions and their outcomes. The effects on patient-oriented outcomes and disease-oriented outcomes were ambiguous. CONCLUSION: Little research has been performed on health outcomes of interventions aiming to increase patient participation in general practice visits among patients suffering from symptom-based complaints. The results still are non-conclusive. The quality of the trials has been weak, possibly due to the complexity of the concept. This weak quality may explain the lack of conclusive results. Proposals for future research designs are offered.

The effects of physicians' affect-oriented communication style and raising expectations on analogue patients' anxiety, affect and expectancies.

OBJECTIVE: Patients' affect and expectancies can set off placebo effects and thus impact patients' health. We assessed the relative effects of physicians' affect-oriented communication style and raising expectations on patients' affective state and outcome expectancies. METHOD: Thirty healthy women presented severe menstrual pain in a scripted consultation with a general practitioner (GP). In a 2x2 randomized controlled trial, the GP communicated in a warm, empathic or cold, formal way and raised positive or uncertain expectations. Effects on subjects' state anxiety, affective state and outcome expectancies were assessed. RESULTS: Only warm, empathic communication combined with positive expectations led to a significant and relevant decrease in state anxiety. Subjects' positive and negative affects were influenced by GPs affect-oriented communication style. Negative affect and outcome expectancies are influenced by GP suggestions about outcomes. CONCLUSION: Manipulations in physicians' affect-oriented and expectancy-related communication can have a large impact on patients' affective state and outcome expectations. A combination of a warm, empathic communication style and raising positive expectations resulted in optimal subject outcomes. PRACTICE IMPLICATIONS: Physicians should take into account that communicating in warm, empathic way combined with raising positive expectations seems to lead to the most favorable effects on patients' state anxiety and outcome expectancies.