Most healthcare interventions tested in Cochrane Reviews are not effective according to high quality evidence: a systematic review and meta-analysis.

OBJECTIVE: To estimate the proportion of healthcare interventions tested within Cochrane Reviews that are effective according to high-quality evidence. METHODS: We selected a random sample of 2,428 (35%) of all Cochrane Reviews published between 1 January 2008 and 5 March 2021. We extracted data about interventions within these reviews that were compared with placebo, or no treatment, and whose outcome quality was rated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. We calculated the proportion of interventions whose benefits were based on high-quality evidence (defined as having high quality GRADE rating for at least one primary outcome, statistically significant positive results, and being judged by review authors as effective. We also calculated the proportion of interventions that suggested harm. RESULTS: Of 1,567 eligible interventions, 87 (5.6%) had high-quality evidence supporting their benefits. Harms were measured for 577 (36.8%) interventions. There was statistically significant evidence for harm in 127 (8.1%) of these. Our dependence on the reliability of Cochrane author assessments (including their GRADE assessments) was the main potential limitation of our study. CONCLUSION: More than 9 in 10 healthcare interventions studied within recent Cochrane Reviews are not supported by high-quality evidence, and harms are under-reported.

Prediction of outcome in internet-delivered cognitive behaviour therapy for paediatric obsessive-compulsive disorder: A machine learning approach.

BACKGROUND: There are no consistent predictors of treatment outcome in paediatric obsessive-compulsive disorder (OCD). One reason for this might be the use of suboptimal statistical methodology. Machine learning is an approach to efficiently analyse complex data. Machine learning has been widely used within other fields, but has rarely been tested in the prediction of paediatric mental health treatment outcomes. OBJECTIVE: To test four different machine learning methods in the prediction of treatment response in a sample of paediatric OCD patients who had received Internet-delivered cognitive behaviour therapy (ICBT). METHODS: Participants were 61 adolescents (12-17 years) who enrolled in a randomized controlled trial and received ICBT. All clinical baseline variables were used to predict strictly defined treatment response status three months after ICBT. Four machine learning algorithms were implemented. For comparison, we also employed a traditional logistic regression approach. RESULTS: Multivariate logistic regression could not detect any significant predictors. In contrast, all four machine learning algorithms performed well in the prediction of treatment response, with 75 to 83% accuracy. CONCLUSIONS: The results suggest that machine learning algorithms can successfully be applied to predict paediatric OCD treatment outcome. Validation studies and studies in other disorders are warranted.

Observation oriented modeling revised from a statistical point of view.

Observation Oriented Modeling was proposed to overcome some of the problems in the application of statistical inference methods in the behavioral sciences. In this paper, we refine one part of this approach and show how it is connected to methods that are well known in statistical learning. Specifically, we argue that the Moore-Penrose pseudo inverse is superior to the initial solution from a statistical point of view. With this we also show that Observation Oriented Modeling can indeed be appropriate for some tasks in the analysis of observed data. To provide a practical example, we demonstrate the revised method by analyzing the effect of mindfulness training on attentional processes.

[Psychological distress in medical students - a comparison of the Universities of Munich and Witten/Herdecke]. / Psychische Belastungen von Medizinstudierenden an den Universitäten München und Witten/Herdecke - ein Vergleich.

OBJECTIVES: This study compares the distress levels of medical students in two different academic settings. METHODS: Data were collected from N= 76 medical students at the Witten/Herdecke University (UW/H) and N = 343 medical students at Ludwig Maximilians University Munich (LMU) with an online questionnaire battery of established questionnaire instruments for assessing distress as well as life and study satisfaction (SWE, ADS-K, PSQ, SF-12, STQL-S). RESULTS: Data analysis revealed significant differences between the students with regard to self efficacy expectation, depression, psychological distress, and satisfaction. CONCLUSIONS: Because no differences in coping strategies were found between the two groups of students, with the exception of relaxation techniques, the impact of contextual and structural factors on medical students' well-being is discussed.

Quality of life in patients with fibromyalgia: validation and psychometric properties of the German Quality of Life Scale (QOLS-G).

Our objectives were to translate the Quality of Life Scale (QOLS) into German and to evaluate its reliability and validity for the use in patients with fibromyalgia (FMS). Together with German versions of the Fibromyalgia Impact Questionnaire (FIQ), the SF-36, a tender point count (TPC) and other questionnaires, we administered the QOLS to 146 patients with FMS. Patients were asked about the severity of pain today (VAS) and the duration of symptoms. Test-retest reliability was assessed using Spearman's correlations. Internal consistency was evaluated with Cronbach's alpha. Construct validity of the QOLS was evaluated by correlating the QOLS with the FIQ, the SF-36, the Beck Depression Inventory (BDI), and the Symptom Checklist (SCL-90-R) as well as with the pain variables. An exploratory factor analysis (EFA) was also conducted. Mean age was 53.1 years. Means were for pain today 6.8 and for duration of symptoms 11.8 years. Test-retest reliability for the total QOLS was rho = .91. Internal consistency was α = .90. Low-to-moderate correlations were obtained between the QOLS and the total FIQ (rho = -.42), the SF-36 (e.g. physical functioning rho = .37; mental health rho = .56) as well as the pain variables (VAS rho = -.11 ns; TPC rho = -.20). Psychological variables were moderately to substantially correlated with the QOLS (e.g. BDI rho = -.61). An EFA suggested a three-factor solution. The QOLS-G is a reliable and valid instrument for measuring quality of life in German patients with FMS.

Implicit and explicit emotional behavior and mindfulness.

The objective of this study was to examine whether the "step back and watch" attitude of mindfulness manifests in less emotional behavior. We hypothesized that the "acceptance" facet of mindfulness, but not the "presence" facet, is negatively associated with the magnitude of emotional behavior in four tests, i.e., (1) rating of words, (2) rating of aversive and neutral pictures, and (3) evaluative conditioning (EC). Additionally, we hypothesized that (4) the acceptance facet is associated with increased reaction time (RT) in an emotional Stroop test, and that the presence facet is associated with decreased RT and lower error rate. The sample consisted of N=247 non-clinical adults and was tested in a cross-sectional study. The results provide partial evidence that the acceptance facet of mindfulness may be associated with less aversive reactions towards aversive stimuli. Future studies should substantiate these findings but also determine their clinical relevance.

Spirituality: an overlooked predictor of placebo effects?

Empirical findings have identified spirituality as a potential health resource. Whereas older research has associated such effects with the social component of religion, newer conceptualizations propose that spiritual experiences and the intrapersonal effects that are facilitated by regular spiritual practice might be pivotal to understanding potential salutogenesis. Ongoing studies suggest that spiritual experiences and practices involve a variety of neural systems that may facilitate neural 'top-down' effects that are comparable if not identical to those engaged in placebo responses. As meaningfulness seems to be both a hallmark of spirituality and placebo reactions, it may be regarded as an overarching psychological concept that is important to engaging and facilitating psychophysiological mechanisms that are involved in health-related effects. Empirical evidence suggests that spirituality may under certain conditions be a predictor of placebo response and effects. Assessment of patients' spirituality and making use of various resources to accommodate patients' spiritual needs reflect our most current understanding of the physiological, psychological and socio-cultural aspects of spirituality, and may also increase the likelihood of eliciting self-healing processes. We advocate the position that a research agenda addressing responses and effects of both placebo and spirituality could therefore be (i) synergistic, (ii) valuable to each phenomenon on its own, and (iii) contributory to an extended placebo paradigm that is centred around the concept of meaningfulness.

Dialectics of mindfulness: implications for western medicine.

Mindfulness as a clinical and nonclinical intervention for a variety of symptoms has recently received a substantial amount of interest. Although the application of mindfulness appears straightforward and its effectiveness is well supported, the concept may easily be misunderstood. This misunderstanding may severely limit the benefit of mindfulness-based interventions. It is therefore necessary to understand that the characteristics of mindfulness are based on a set of seemingly paradoxical structures. This article discusses the underlying paradox by disentangling it into five dialectical positions - activity vs. passivity, wanting vs. non-wanting, changing vs. non-changing, non-judging vs. non-reacting, and active acceptance vs. passive acceptance, respectively. Finally, the practical implications for the medical professional as well as potential caveats are discussed.

Spirituality and the International Classification of Functioning, Disability and Health: content comparison of questionnaires measuring mindfulness based on the International Classification of Functioning.

PURPOSE: To identify and compare the concepts contained in questionnaires measuring mindfulness using the International Classification of Functioning (ICF) as external reference. METHOD: Questionnaires which are published in peer-reviewed journals and listed in Pubmed or PsycInfo were included. The questionnaires were analysed and, using a content-analytical approach, the respective items were categorised and linked to the ICF. RESULTS: Ten questionnaires were included. Ninety-four per cent (N = 341) of the concepts could be linked to 37 different ICF categories. One hundred and seventy-one (50.1%) concepts were linked to ICF categories of the component Body Function, 74 (21.7%) to categories of the component Activity and Participation and none to categories of the component Environmental Factors. In total, 28.2% of the linked concepts belonged to Personal factors, which are not yet classified in the ICF. The questionnaires exhibited considerable differences regarding content density (i.e. the average number of concepts per item) and content diversity (i.e. the number of ICF categories per concept). CONCLUSIONS: The ICF provides an useful external reference to identify and compare the concepts contained in mindfulness questionnaires. Also, mindfulness questionnaire concepts suggest potentially useful factors for classification within the ICF.