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Subjective expectations are known to be associated with clinical outcomes. However, expectations exist about different aspects of recovery, and few studies have focused on expectations about specific treatments. Here, we present results from a prospective observational study of patients receiving lumbar steroid injections against low back pain (N = 252). Patients completed questionnaires directly before (T1), directly after (T2), and 2 weeks after (T3) the injection. In addition to pain intensity, we assessed expectations (and certainty therein) about treatment effects, using both numerical rating scale (NRS) and the Expectation for Treatment Scale (ETS). Regression models were used to explain (within-sample) treatment outcome (pain intensity at T3) based on pain levels, expectations, and certainty at T1 and T2. Using cross-validation, we examined the models' ability to predict (out-of-sample) treatment outcome. Pain intensity significantly decreased (P < 10−15) 2 weeks after injections, with a reduction of the median NRS score from 6 to 3. Numerical Rating Scale measures of pain, expectation, and certainty from T1 jointly explained treatment outcome (P < 10−15, R2 = 0.31). Expectations at T1 explained outcome on its own (P < 10−10,f2=0.19) and enabled out-of-sample predictions about outcome (P < 10−4), with a median error of 1.36 on a 0 to 10 NRS. Including measures from T2 did not significantly improve models. Using the ETS as an alternative measurement of treatment expectations (sensitivity analysis) gave consistent results. Our results demonstrate that treatment expectations play an important role for clinical outcome after lumbar injections and may represent targets for concomitant cognitive interventions. Predicting outcomes based on simple questionnaires might be useful to support treatment selection.

Objectives To revise a sex and gender appraisal tool for systematic reviews (SGAT-SR) and apply it to Cochrane sepsis reviews. Study design and setting The revision process was informed by existing literature on sex, gender, intersectionality, and feedback from an expert advisory board. We revised the items to consider additional factors associated with health inequities and appraised sex and gender considerations using the SGAT-SR-2 and female Participation-to-Prevalence Ratio (PPR) in Cochrane sepsis reviews. Results SGAT-SR-2 consists of 19 questions appraising the review's sections and use of the terms sex and gender. amongst 71 SRs assessed, 50.7% included at least one tool item, the most frequent being the number of participants by sex or gender at included study-level (24/71 reviews). Only four reviews provided disaggregated data for the full set of included trials, while two considered other equity-related factors. Reviews rarely appraised possible similarities and differences across sex and gender. In half of a subset of reviews, female participants were under-represented relative to their share of the sepsis population (PPR

Background: Most individuals affected by cancer who are treated with certain chemotherapies suffer of CIPN. Therefore, there is a high patient and provider interest in complementary non-pharmacological therapies, but its evidence base has not yet been clearly pointed out in the context of CIPN. Methods: The results of a scoping review overviewing the published clinical evidence on the application of complementary therapies for improving the complex CIPN symptomatology are synthesized with the recommendations of an expert consensus process aiming to draw attention to supportive strategies for CIPN. The scoping review, registered at PROSPERO 2020 (CRD 42020165851), followed the PRISMA-ScR and JBI guidelines. Relevant studies published in Pubmed/MEDLINE, PsycINFO, PEDro, Cochrane CENTRAL, and CINAHL between 2000 and 2021 were included. CASP was used to evaluate the methodologic quality of the studies. Results: Seventy-five studies with mixed study quality met the inclusion criteria. Manipulative therapies (including massage, reflexology, therapeutic touch), rhythmical embrocations, movement and mind–body therapies, acupuncture/acupressure, and TENS/Scrambler therapy were the most frequently analyzed in research and may be effective treatment options for CIPN. The expert panel approved 17 supportive interventions, most of them were phytotherapeutic interventions including external applications and cryotherapy, hydrotherapy, and tactile stimulation. More than two-thirds of the consented interventions were rated with moderate to high perceived clinical effectiveness in therapeutic use. Conclusions: The evidence of both the review and the expert panel supports a variety of complementary procedures regarding the supportive treatment of CIPN; however, the application on patients should be individually weighed in each case. Based on this meta-synthesis, interprofessional healthcare teams may open up a dialogue with patients interested in non-pharmacological treatment options to tailor complementary counselling and treatments to their needs.

We thank Merkaš and Lakušić for commenting on our recently published paper; in the paper, we suggested that resources in a patient’s social environment may moderate the benefit of one single-session trauma-focused counseling in the prevention of acute coronary syndrome (ACS)-induced posttraumatic stress disorder (PTSD) symptoms [...]

Objectives: Intervention integrity is the degree to which the study intervention is delivered as intended. This article presents the RIPI-f checklist (Reporting Integrity of Psychological Interventions delivered face-to-face) and summarizes its development methods. RIPI-f proposes guidance for reporting intervention integrity in evaluative studies of face-to-face psychological interventions. Study Design and Setting: We followed established procedures for developing reporting guidelines. We examined 56 documents (reporting guidelines, bias tools, and methodological guidance) for relevant aspects of face-to-face psychological intervention integrity. Eighty four items were identified and grouped as per the template for intervention description and replication (TIDieR) domains. Twenty nine experts from psychology and medicine and other scholars rated the relevance of each item in a single-round Delphi survey.Amultidisciplinary panel of 11 experts discussed the survey results in three online consensus meetings and drafted the final version of the checklist. Results: We propose RIPI-f, a checklist with 50 items. Our checklist enhances TIDieR with important extensions, such as therapeutic alliance, provider’s allegiance, and the adherence of providers and participants. Conclusion: RIPI-f can improve the reporting of face-to-face psychological interventions. The tool can help authors, researchers, systematic reviewers, and guideline developers. We suggest using RIPI-f alongside other reporting guidelines. post-print 504 KB

Background Chronic health conditions have a big impact on disability, morbidity, and mortality worldwide. Smartphone health applications (apps) can improve the health of patients with chronic conditions and enhance the quality and efficiency of healthcare. The number of randomized controlled trials (RCTs) of smartphone health apps is increasing, but a collection of the available evidence into a single database is still missing. The purpose of this study is to describe Smartphone-RCCT, which is an in-progress database of RCTs of smartphone apps for chronic conditions. Methods For a study to be included in the database, the following criteria had to be met: (a) RCT published in a peer-reviewed journal; (b) population: adult study participants with one or several chronic conditions that represent the main health problem addressed by the study intervention; (c) intervention: smartphone health app used by the patient; (d) comparator: any control condition; (e) outcomes: any patient-reported health outcome (studies exclusively measuring the patients’ knowledge about the chronic conditions or their satisfaction with the smartphone app were excluded); (f) sample size: at least 15 participants per study arm. We searched in electronic databases and other resources to identify relevant studies. Two reviewers selected the studies and extracted data independently. Annual updates are planned. Results The proposed database is called Smartphone-RCCT, an open-access repository collecting bibliographic references and important characteristics of RCTs of smartphone apps for chronic conditions. The database is available for free in Open Science Framework (OSF): https://osf.io/nxerf/. To date, it includes 70 trials. Their references can be exported to standard reference management software and the extracted data is available in a Microsoft Excel file. Conclusions Smartphone-RCCT is the first systematic open-access database collecting peer-reviewed publications of RCTs of smartphone apps for patients with chronic conditions. The database accelerates the delivery of evidence-based information in a dynamic research field. It represents an essential resource for different stakeholders, such as professionals working in evidence synthesis, meta-epidemiological studies, or planning an RCT.

PURPOSE The aim of this joint guideline is to provide evidence-based recommendations to practicing physicians and other health care providers on integrative approaches to managing pain in patients with cancer. METHODS The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation oncology, surgical oncology, palliative oncology, social sciences, mind-body medicine, nursing, and patient advocacy representatives. The literature search included systematic reviews, meta-analyses, and randomized controlled trials published from 1990 through 2021. Outcomes of interest included pain intensity, symptom relief, and adverse events. Expert panel members used this evidence and informal consensus to develop evidence-based guideline recommendations. RESULTS The literature search identified 227 relevant studies to inform the evidence base for this guideline. RECOMMENDATIONS Among adult patients, acupuncture should be recommended for aromatase inhibitor–related joint pain. Acupuncture or reflexology or acupressure may be recommended for general cancer pain or musculoskeletal pain. Hypnosis may be recommended to patients who experience procedural pain. Massage may be recommended to patients experiencing pain during palliative or hospice care. These recommendations are based on an intermediate level of evidence, benefit outweighing risk, and with moderate strength of recommendation. The quality of evidence for other mind-body interventions or natural products for pain is either low or inconclusive. There is insufficient or inconclusive evidence to make recommendations for pediatric patients. More research is needed to better characterize the role of integrative medicine interventions in the care of patients with cancer. Additional information is available at https://integrativeonc.org/practice-guidelines/guidelines and www.asco.org/survivorship-guidelines .

In this project, an e-Learning program for complementary and integrative medicine in oncology was systematically developed, implemented, and evaluated in a stepwise procedure. Learning objectives and content were defined within the KOKON project network, considering the educational competencies for integrative oncology. To design a valuable e-Learning, experts were involved in all relevant steps of the process, as well as stakeholders from various target groups (undergraduates: medicine students, postgraduates: oncology physicians). We used mixed methods including quantitative surveys, progress tests, and qualitative focus groups. The developed e-Learning program led to a significant measurable knowledge gain about complementary and integrative medicine. In parallel, physicians and students were subjectively satisfied with the training. For the majority of e-Learning elements, the needs of both target groups are comparable. Furthermore, both groups emphasized the value of formative assessment tools for gaining knowledge. From the various surveys and experiences collected in this project, we derive recommendations for others developing e-Learning programs.

Background Since establishing the first poison control centers (PCCs), there is a still ongoing debate regarding their relevance and financing. The present study aims to analyze whether a regional PCC can reduce the economic burden associated with utilization of health care structures due to low-risk poison exposures on the German health care system. Methods A decision-tree based cost–benefit analysis comparing a situation utilizing PCC consultation versus a hypothetical situation without PCC consultation for low-risk poison exposures from the German health care system's perspective was conducted. The model inputs were obtained by a representative telephone survey of lay callers supplemented by empirical PCC and literature data. A probabilistic and deterministic sensitivity analysis with varying input variables was performed to prove the robustness of the findings. Results In the underlying telephone survey, data of 378 lay callers could be considered and included in the decision tree model. As a result, the mean costs for handling one low-risk poison exposure case were €41.99 utilizing PCC consultation compared to €145.92 without PCC consultation, indicating a cost–benefit ratio of 3.48 for the existence of the PCC. The sensitivity analysis proved that the outcome of the decision analysis does not change significantly with varying inputs. Conclusion The existence of PCCs relieve the burden on other health care providers and reduce health care costs to a relevant extent. Therefore, PCCs should be considered as an important supporting structure of the German health care system.

BACKGROUND A one-size-fits-all approach might explain why early psychological interventions are largely ineffective in preventing the development of posttraumatic stress disorder (PTSD) symptoms triggered by acute medical events. We examined the hypothesis that social and health care resources are moderators of an intervention effect. METHODS Within 48 h of hospital admission, 129 patients (mean age 58 years, 83% men) with acute coronary syndrome (ACS) self-rated their social support and were randomized to one single session of trauma-focused counseling (TFC) or stress-focused counseling (SFC) (active control intervention). Clinician-rated PTSD symptoms, use of cardiac rehabilitation (CR) and use of psychotherapy were assessed at 3 and 12 months. Random mixed regression multivariable models were used to analyze associations with PTSD symptoms over time. RESULTS TFC did not prevent ACS-induced PTSD symptom onset better than SFC; yet, there were significant and independent interactions between "intervention" (TFC or SFC) and social support (p = 0.013) and between "intervention" and duration of CR in weeks (p = 0.034). Patients with greater social support or longer participation in CR had fewer PTSD symptoms in the TFC group compared with the SFC group. The number of psychotherapy sessions did not moderate the intervention effect. CONCLUSIONS Early psychological intervention after ACS with a trauma-focused approach to prevent the development of PTSD symptoms may be beneficial for patients who perceive high social support or participate in CR for several weeks.

BACKGROUND Elevated levels of C-reactive protein (CRP) are associated with both an increased risk of cardiovascular disease (CVD) and depression. We aimed to test the hypothesis that a self-report history of depression is associated with a smaller decrease in CRP levels from hospital admission to 3-month follow-up in patients with acute myocardial infarction (MI). METHODS We assessed 183 patients (median age 59 years; 84% men) with verified MI for a self-report history of lifetime depression and plasma CRP levels within 48 h of an acute coronary intervention and again for CRP levels at three months. CRP values were categorized according to their potential to predict CVD risk at hospital admission (acute inflammatory response: 0 to

Background Chronic neck pain is a highly prevalent condition. Learning a relaxation technique is recommended by numerous guidelines for chronic neck pain. Smartphone apps can provide relaxation exercises; however, their effectiveness, especially in a self-care setting, is unclear. Objective The aim of this pragmatic randomized trial is to evaluate whether app-based relaxation exercises, including audio-based autogenic training, mindfulness meditation, or guided imagery, are more effective in reducing chronic neck pain than usual care alone. Methods Smartphone owners aged 18 to 65 years with chronic (>12 weeks) neck pain and the previous week’s average neck pain intensity ≥4 on the Numeric Rating Scale (0=no pain to 10=worst possible pain) were randomized into either an intervention group to practice app-based relaxation exercises or a control group (usual care and app for data entry only). For both groups, the follow-up data were collected using app-based diaries and questionnaires. The primary outcome was the mean neck pain intensity during the first 3 months based on daily measurements. Secondary outcomes included neck pain based on weekly measurements, pain acceptance, neck pain–related stress, sick-leave days, pain medication intake, and adherence, which were all measured until the 6-month follow-up. For the primary analysis, analysis of covariance adjusted for baseline neck pain intensity was used. Results We screened 748 participants and enrolled 220 participants (mean age 38.9, SD 11.3 years; mean baseline neck pain 5.7, SD 1.3 points). The mean neck pain intensity in both groups decreased over 3 months; however, no statistically significant difference between the groups was found (intervention: 4.1 points, 95% CI 3.8-4.4; control: 3.8 points, 95% CI 3.5-4.1; group difference: 0.3 points, 95% CI −0.2 to 0.7; P=.23). In addition, no statistically significant between-group differences regarding neck pain intensity after 6 months, responder rate, pain acceptance, pain medication intake, or sick-leave days were observed. There were no serious adverse events that were considered related to the trial intervention. In week 12, only 40% (44/110) of the participants in the intervention group continued to practice the exercises with the app. Conclusions The study app did not effectively reduce chronic neck pain or keep the participants engaged in exercising in a self-care setting. Future studies on app-based relaxation interventions should take into account the most recent scientific findings for behavior change techniques. Trial Registration ClinicalTrials.gov NCT02019134; https://clinicaltrials.gov/ct2/show/NCT02019134 International Registered Report Identifier (IRRID) RR2-10.1186/1745-6215-15-490

Third molar extraction is a painful treatment for patients, and thus, it can be used to investigate the effects of analgesics on pain. Hypnosis can help to reduce pain and to decrease the intake of postoperative systemic analgesics. In this study, the effectiveness of a brief hypnotic induction for patients undergoing third molar extractions was investigated. Data were collected from 33 patients with third molar extractions on the right and left sides. Patients received 2 different types of pain interventions in this monocentric randomized crossover trial. Third molar extraction was conducted on 1 side with reduced preoperative local anesthetics and an additional brief hypnotic induction (Dave Elman technique). The other side was conducted with regular preoperative local anesthetics without a brief hypnotic induction (standard care). Intake of postoperative systemic analgesics was allowed in both treatments. Patients' expectations about hypnosis were assessed at baseline. The primary outcome was the area under the curve with respect to ground of pain intensity after the treatment. Secondary outcomes were the amount of postoperative analgesics consumed and the preferred treatment. There was no evidence that the area under the curve with respect to ground of pain differed between the 2 interventions (controlling for gender), but the patients' expectations affected the effectiveness of the brief hypnotic induction. This means that patients with high expectations about hypnosis benefit more from treatment with reduced preoperative local anesthetics and additional brief hypnotic induction. PERSPECTIVE: Hypnosis is used as a treatment to reduce pain in general and dental settings. In this study, additional a brief hypnotic induction with reduced preoperative local anesthetic use did not generally reduce posttreatment pain after third molar extraction more than regular local anesthetics. The expectation of the patients about the effectiveness of hypnosis affected the effectiveness of the brief hypnotic induction so that patients with high expectations had a larger benefit from a brief hypnotic induction than patients with low expectations.

Objective Psychological consequences of myocardial infarction (MI) are substantial, as 4% of all MI patients develop posttraumatic stress disorder (PTSD) and 12% clinically relevant posttraumatic stress symptoms (PTSS). The study investigated the course and development within 12 months of MI-induced PTSS to gain novel insights in potentially delayed response to early trauma-focused counseling aimed at preventing the incidence of MI-induced PTSS. Methods In the MI-SPRINT two-group randomized controlled trial, 190 MI-patients were randomly allocated to receive a single-session intervention of either trauma-focused counseling or an active control intervention targeting the general role of stress in patients with heart disease. Blind interviewer-rated PTSS (primary outcome) and additional health outcomes were assessed at 12-month follow-up. Results 12-month follow-up of outcomes were available for 106 (55.8%) of 190 participants: In the entire sample, one patient (0·5%, 1/190) who received trauma-focused counseling developed full PTSD. There was no significant difference between trauma-focused counseling and stress counseling regarding total score of interviewer-rated PTSS (p > 0.05). The only group difference emerged in terms of more severe hyperarousal symptoms in the trauma-focused counseling group in the ITT analysis, but not in the completer analysis. Conclusions No benefits were found for trauma-focused counseling after 12 months when compared with an active control intervention. PTSD prevalence in the present study was low highlighting a potential beneficial effect of both interventions. Further studies are needed to determine the most accurate approach of counseling.

Background: Ayurveda is widely practiced in South Asia in the treatment of osteoarthritis (OA). The aim of these secondary data analyses were to identify the most relevant variables for treatment response and group differences between Ayurvedic therapy compared to conventional therapy in knee OA patients. Methods: A total of 151 patients (Ayurveda n = 77, conventional care n = 74) were analyzed according to the intention-to-treat principle in a randomized controlled trial. Different statistical approaches including generalized linear models, a radial basis function (RBF) network, exhausted CHAID, classification and regression trees (CART), and C5.0 with adaptive boosting were applied. Results: The RBF network implicated that the therapy arm and the baseline values of the WOMAC Index subscales might be the most important variables for the significant between-group differences of the WOMAC Index from baseline to 12 weeks in favor of Ayurveda. The intake of nutritional supplements in the Ayurveda group did not seem to be a significant factor in changes in the WOMAC Index. Ayurveda patients with functional limitations > 60 points and pain > 25 points at baseline showed the greatest improvements in the WOMAC Index from baseline to 12 weeks (mean value 107.8 +/- 27.4). A C5.0 model with nine predictors had a predictive accuracy of 89.4% for a change in the WOMAC Index after 12 weeks > 10. With adaptive boosting, the accuracy rose to 98%. Conclusions: These secondary analyses suggested that therapeutic effects cannot be explained by the therapies themselves alone, although they were the most important factors in the applied models.

Background After acute coronary syndrome (ACS), one in eight patients develops clinically significant symptoms of Post-traumatic stress disorder (PTSD). We hypothesized that changes in cardiac symptoms from 3 to 12 months after ACS are associated with changes in ACS-induced PTSD symptoms. Methods At 3 (n = 154) and/or 12 months (n = 106) post-ACS, patients (n = 156, mean age 59 years, 85% men) completed a clinical interview assessing chest tightness/pain (at rest and/or during exertion), heartbeat symptoms (heart palpitations, racing of heart, heart stumbling or skipping a beat) and PTSD symptoms during the prior 4 weeks. Random mixed regression models examined the association between the onset (or remission) from 3 to 12 months in cardiac symptoms with changes in PTSD symptoms, adjusting for a range of potential predictors of ACS-induced PTSD symptoms. Results The onset of chest tightness/pain [estimate = 0.588, 95% confidence interval: 0.275, 0.090; p < 0.001] and of heartbeat symptoms [0.548 (0.165, 0.931); p = 0.005] from 3 to 12 months was independently associated with an increase in total PTSD symptoms. There were also independent associations between the onset of chest tightness/pain and heartbeat symptoms with an increase in PTSD symptom clusters. Specifically, the onset of chest tightness/pain showed associations with an increase in re-experiencing [0.450 (0.167, 0.733); p = 0.027] and avoidance/numbing [0.287 (0.001, 0.574); p = 0.049]. The onset of heartbeat symptoms showed associations with an increase in re-experiencing [0.392 (0.045, 0.739); p = 0.002], avoidance/numbing [0.513 (0.161, 0.864); p = 0.004] and hyperarousal [0.355 (0.051, 0.659); p = 0.022]. An increase in the total number of cardiac symptoms (score range 0-6) was also associated with an increase in total PTSD symptoms [0.343 (0.202, 0.484); p < 0.001]. Psychotherapy in the post-hospital period moderated the association between the change in heartbeat symptoms and the change in total PTSD symptoms [-0.813 (-1.553, -0.074); p = 0.031 for interaction]; the association between the onset of heart beat symptoms and an increase in total PTSD symptoms was weaker in patients who attended psychotherapy [0.437 (-0.178, 1.052); p = 0.16] than in those who did not [0.825 (0.341, 1.309); p < 0.001]. Conclusion Changes in cardiac symptoms between 3 and 12 months after hospitalization are associated with changes in ACS-induced PTSD symptoms. ClinicalTrials.gov #NCT01781247.

BACKGROUND Sleep disturbance has been associated with poor prognosis in patients with acute coronary syndrome (ACS). This study examined the course of sleep disturbance and associated factors in patients with ACS who were followed for one year. METHODS Study participants were 180 patients (mean age 59.6 years, 81.7% men) with ACS admitted to a tertiary hospital to undergo acute coronary intervention. Sleep disturbance was interviewer-assessed at admission (n = 180), at 3 months (n = 146), and at 12 months (n = 101) using the Jenkins Sleep Scale (JSS)-4, with a total of 414 assessments over one year. Random linear mixed regression models were used to evaluate the relationship between sociodemographic factors, cardiac diseases severity, perceived distress during ACS, comorbidities, medication, health behaviors, and sleep disturbance over time. RESULTS At admission, 3 months, and 12 months, 56.7%, 49.3%, and 49.5% of patients, respectively, scored above the mean value for sleep disturbance in the general population (JSS-4 score ≥5). There was a significant decrease in continuous JSS-4 scores over time [estimate (SE) = -0.211 (0.074), p = 0.005]. Female sex [0.526 (0.206), p = 0.012], greater fear of dying [0.074 (0.026), p = 0.004], helplessness during ACS [0.062 (0.029), p = 0.034], and a history of depression [0.422 (0.171), p = 0.015] were independently associated with higher JSS-4 scores over time. CONCLUSION Despite a decrease from admission to 3 months, sleep disturbance is prevalent in the first year after ACS. Female sex, depression history, and distress during ACS identify patients at increased risk of developing persistent sleep disturbance and may inform interventions to prevent sleep disturbance.

Museum engagement may be an effective approach for decreasing social disconnection and pain among individuals living with chronic pain. In October 2019, we launched a randomized controlled trial to assess the feasibility of museum engagement for individuals living with chronic pain; the study was halted in March, 2020 due to Covid-19-related safety concerns. This paper describes the process of transitioning from in-person to virtual museum programing in order to continue the study. Virtual museum programing is a feasible option for individuals living with chronic pain that is amenable to research and which may improve accessibility, inclusivity, and scalability relative to in-person programing.