Efficiency and contribution of strategies for finding randomized controlled trials: a case study from a systematic review on therapeutic interventions of chronic depression

Background. Identifying all existing evidence is a crucial aspect in conducting systematic reviews. Since the retrieval of electronic database searches alone is limited, guidelines recommend the use of addi- tional search strategies. The aim of this investigation was to assess the efficiency and contribution of additional search strategies for identifying randomized controlled trials in conducting a systematic review on interventions after performing a sensitive electronic database search. Design and Methods. Seven electronic databases, 3 journals and 11 systematic reviews were searched. All first authors of the included studies were contacted; citation tracking and a search in clinical trial registers were performed. A priori defined evaluation criteria were calculated for each search strategy. Results. A total of 358 full-text articles were identified; 50 studies were included in the systematic review, wherefrom 84.0% (42) were acquired by the sensitive electronic database search and 16.0% (8) through additional search strategies. Screening reference lists of related systematic reviews was the most beneficial additional search strategy, with an efficiency of 31.3% (5) and a contribution of 10.0% (5/50), whereas hand-searching and author contacts contributed two and one additional studies, respectively. Citation tracking and searching clinical trial registers did not lead to any further inclusion of primary studies. Conclusions. Based on our findings, hand-searching contents of relevant journals and screening reference lists of related systematic reviews may be helpful additional strategies to identify an extensive body of evidence. In case of limited resources, a sensitive electronic database search may constitute an appropriate alternative for identifying relevant trials

Psychometric evaluation of the German version of the patient activation measure (PAM13)

BACKGROUND: The Patient Activation Measure (PAM) consists of 13 items and assesses patient (or consumer) self-reported knowledge, skills, and confidence for self-management of one’s health or chronic condition. The aim of this study was to translate the original American version of the PAM13 into German and to test the psychometric properties of the German version in an elderly, multimorbid population with various chronic conditions. METHODS: Translation was performed by a standardized forward-backward translation process. The PAM13 was sent to 9.075 participants enrolled in a randomized controlled study. 4.306 participants responded to the questionnaire. Descriptive and reliability analyses were carried out. To examine scale properties, Andrich’s Rasch Rating Scale Model was fitted. RESULTS: The internal consistency is good (α = 0.88) and the item-rest-correlations were found as strong to moderate. The unidimensionality of the construct was confirmed, with a variance explanation of 40.9% and good model-fits for the Rasch model. However, the lowest response options were very rarely used across all items (below 5%) and ranking order of items according to their difficulty was substantially different from that of the American version. Differential item functioning (DIF) was found in subgroups (sex, age, health status), but differences were small. CONCLUSION: The German version of the PAM13 showed acceptable reliability and the model-fit statistics confirmed the Rasch model. The different ranking order of the items and the unfair distribution of the response options suggest further research on validation and revision of the construct

Study protocol of a randomized controlled trial on two new dissemination strategies for a brief, shared-decision-making (SDM) training for oncologists: web-based interactive SDM online-training versus individualized context-based SDM face-to-face training

Background: Oncological patients often feel left out of important treatment decisions. However, when physicians engage them in shared decision-making (SDM), patients benefit in many ways and the situation is improved. SDM can effectively be taught to physicians, but participation barriers for SDM physician group trainings are high, making it hard to convince physicians to participate. With this in mind, we aim to develop and evaluate two new dissemination strategies for a brief, SDM training program based upon a proven SDM group-training concept: an individualized context-based SDM face-to-face training (IG I) and a web-based interactive SDM online training (IG II). We aim to analyze which improvements can be achieved by IG I and II compared to a control group (CG) in physician SDM competence and performance as well as the impact on the physician-patient relationship. Furthermore, we analyze differences in satisfaction concerning the two dissemination strategies by means of a training evaluation. Methods/design: We examine – based on a three-armed randomized controlled trial (IG I, IG II, CG) – the effectiveness of two new dissemination strategies for a SDM training program compared to a CG receiving no SDM training (voluntary access to SDM training as an incentive for participation after completion of the study). We aim to include 162 physicians randomized to one of the three arms. There will be two assessment points in time (before intervention: T0 and post-training: T1). The main outcome is the SDM competence of physicians as measured by an established observational assessment rating system (OPTION-12) by means of consultations with Standardized Patients. Standardized Patients are individuals trained to act as “real” patients. Secondary outcome measures are the SDM performance (SDM-Q-9) and the Questionnaire on the Quality of Physician-Patient-Interaction (QQPPI) both rated by Standardized Patients as well as the physicians’ training evaluation. Discussion: This trial will assess the effectiveness and acceptability of two new dissemination strategies for a brief, SDM training program for physicians. Opportunities and challenges regarding implementation in daily routines will be discussed. Trial registration: ClinicalTrials.gov, Identifier: NCT02674360. Prospectively registered on 4 February 2016

Crystallization of octadecane solutions treated by ultrasound, in presence of oil resins

Ultrasonic treatment of octadecane solution in hexane was carried out. The influence of acoustic action duration and concentration of resins on the process of crystallization of octadecane solutions is shown

Reboxetine for acute treatment of major depression: systematic review and meta-analysis of published and unpublished placebo and selective serotonin reuptake inhibitor controlled trials

Objectives To assess the benefits and harms of reboxetine versus placebo or selective serotonin reuptake inhibitors (SSRIs) in the acute treatment of depression, and to measure the impact of potential publication bias in trials of reboxetine

Guideline-based stepped and collaborative care for patients with depression in a cluster-randomised trial

Guidelines recommend stepped and collaborative care models (SCM) for depression. We aimed to evaluate the effectiveness of a complex guideline-based SCM for depressed patients. German primary care units were cluster-randomised into intervention (IG) or control group (CG) (3:1 ratio). Adult routine care patients with PHQ-9 ≥ 5 points could participate and received SCM in IG and treatment as usual (TAU) in CG. Primary outcome was change in PHQ-9 from baseline to 12 months (hypothesis: greater reduction in IG). A linear mixed model was calculated with group as fixed effect and practice as random effect, controlling for baseline PHQ-9 (intention-to-treat). 36 primary care units were randomised to IG and 13 to CG. 36 psychotherapists, 6 psychiatrists and 7 clinics participated in SCM. 737 patients were included (IG: n = 569 vs. CG: n = 168); data were available for 60% (IG) and 64% (CG) after 12 months. IG showed 2.4 points greater reduction [95% confidence interval (CI): -3.4 to -1.5, p < 0.001; Cohen's d = 0.45] (adjusted PHQ-9 mean change). Odds of response [odds ratio: 2.8; 95% CI: 1.6 to 4.7] and remission [odds ratio: 3.2; 95% CI: 1.58 to 6.26] were higher in IG. Guideline-based SCM can improve depression care

Testing the Treatment Integrity of the Managing Cancer and Living Meaningfully Psychotherapeutic Intervention for Patients With Advanced Cancer

Introduction: The Managing Cancer and Living Meaningfully (CALM) therapy for patients with advanced cancer was tested against a supportive psycho-oncological counseling intervention (SPI) in a randomized controlled trial (RCT). We investigated whether CALM was delivered as intended (therapists’ adherence); whether CALM therapists with less experience in psycho-oncological care show higher adherence scores; and whether potential overlapping treatment elements between CALM and SPI can be identified (treatment differentiation). Methods: Two trained and blinded raters assessed on 19 items four subscales of the Treatment Integrity Scale covering treatment domains of CALM (SC: Symptom Management and Communication with Health Care Providers; CSR: Changes in Self and Relationship with Others; SMP: Spiritual Well-being and Sense of Meaning and Purpose; FHM: Preparing for the Future, Sustaining Hope and Facing Mortality). A random sample of 150 audio recordings (75 CALM, 75 SPI) were rated on a threepoint Likert scale with 1 = “adherent to some extent,” 2 = “adherent to a sufficient extent,” 3 = “very adherent.” Results: All 19 treatment elements were applied, but in various frequencies. CALM therapists most frequently explored symptoms and/or relationship to health care providers (SC_1: n_applied = 62; 83%) and allowed expression of sadness and anxiety about the progression of disease (FHM_2: n_applied = 62; 83%). The exploration of CALM treatment element SC_1 was most frequently implemented in a satisfactory or excellent manner (n_sufficient or very adherent = 34; 45%), whereas the treatment element SMP_4: Therapist promotes acknowledgment that some life goals may no longer be achievable (n_sufficient or very adherent = 0; 0%) was not implemented in a satisfactory manner. In terms of treatment differentiation, no treatment elements could be identified which were applied significantly more often by CALM therapists than by SPI therapists. Conclusion: Results verify the application of CALM treatment domains. However, CALM therapists’ adherence scores indicated manual deviations. Furthermore, raters were not able to significantly distinguish CALM from SPI, implying that overlapping treatment elements were delivered to patients