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Introduction: This exploratory review aimed to provide empirical evidence on the definitions of labor, the statistical approaches and measures reported in randomized controlled trials (RCTs) and observational studies measuring the duration of labor. Methods: A systematic electronic literature search was conducted using different databases. An extraction form was designed and used to extract relevant data. English, French, and German studies published between 1999 and 2019 have been included. Only RCTs and observational studies analyzing labor duration (or a phase of labor duration) as a primary outcome have been included. Results: Ninety‐two RCTs and 126 observational studies were eligible. No definition of the onset of labor was provided in 21.7% (n = 20) of the RCTs and 23.8% (n = 30) of the observational studies. Mean was the most frequently applied measure of labor duration in the RCTs (89.1%, n = 82), and median in the observational studies (54.8%, n = 69). Most RCTs (83%, n = 76) and observational studies (70.6%, n = 89) analyzed labor duration using a bivariate method, with the t‐test being the most frequently applied (45.7% and 27%, respectively). Only 10.8% (n = 10) of the RCTs and 52.4% (n = 66) of the observational studies conducted a multivariable regression: 3 (30%; out of 10) RCTs and 37 (56%; out of 66) observational studies used a time‐to‐event adapted model. Conclusion: This survey reports a lack of agreement with respect to how the onset of labor and phases of labor duration are presented. Concerning the statistical approaches, few studies used survival analysis, which is the appropriate statistical framework to analyze time‐to‐event data. [ABSTRACT FROM AUTHOR]

Abstract Objective This meta-analysis and systematic review were conducted to comprehensively evaluate the efficacy and safety of mesenchymal stem cells in patients with acute ischemic stroke. Method We conducted a manual search of electronic databases, including PubMed, Embase, the Cochrane Library, and Web of Science, with a search deadline set for February 1, 2023. Data analysis was performed using Stata version 15.0. Result A total of 9 randomized controlled studies were included, involving a total of 316 people, including 159 mesenchymal stem cells and 147 control groups. Results of meta-analysis: Compared to a placebo group, the administration of mesenchymal stem cells resulted in a significant reduction in the National Institutes of Health Stroke Scale (NIHSS) scores among patients diagnosed with acute ischemic stroke [SMD=-0.99,95% CI (-1.93, -0.05)]. Compared to placebo, barthel index [SMD = 0.48,95% CI (-0.55,1.51)], modified rankin score [SMD = 0.45, 95% CI (1.11, 0.21)], adverse events (RR = 0.68, 95% CI (0.40, 1.17)] the difference was not statistically significant. Conclusion Based on current studies, mesenchymal stem cell transplantation can ameliorate neurological deficits in patients with ischemic stroke to a certain extent without increasing adverse reactions. However, there was no significant effect on Barthel index and Modified Rankin score.

Objective: This meta-analysis and systematic review were conducted to comprehensively evaluate the efficacy and safety of mesenchymal stem cells in patients with acute ischemic stroke. Method: We conducted a manual search of electronic databases, including PubMed, Embase, the Cochrane Library, and Web of Science, with a search deadline set for February 1, 2023. Data analysis was performed using Stata version 15.0. Result: A total of 9 randomized controlled studies were included, involving a total of 316 people, including 159 mesenchymal stem cells and 147 control groups. Results of meta-analysis: Compared to a placebo group, the administration of mesenchymal stem cells resulted in a significant reduction in the National Institutes of Health Stroke Scale (NIHSS) scores among patients diagnosed with acute ischemic stroke [SMD=-0.99,95% CI (-1.93, -0.05)]. Compared to placebo, barthel index [SMD = 0.48,95% CI (-0.55,1.51)], modified rankin score [SMD = 0.45, 95% CI (1.11, 0.21)], adverse events (RR = 0.68, 95% CI (0.40, 1.17)] the difference was not statistically significant. Conclusion: Based on current studies, mesenchymal stem cell transplantation can ameliorate neurological deficits in patients with ischemic stroke to a certain extent without increasing adverse reactions. However, there was no significant effect on Barthel index and Modified Rankin score. [ABSTRACT FROM AUTHOR]

Self-compassion interventions may be able to reduce anxiety symptoms. However, the clinical implications of self-compassion interventions remain unclear due to a large variability in treatment protocols. This study was therefore designed to quantify and delineate the effects of self-compassion interventions on anxiety symptoms. Forty-two randomized controlled studies were included through systematic searches. The overall synthesis indicated a moderate effect (42 trials; SMD, −0.73; 95% CI, −0.94 to −0.53; I 2 = 88.7%), and this effect could be maintained to as long as six months following treatment (15 trials; SMD, −0.65; 95% CI, −0.86 to −0.44; I 2 = 72.6%). Specifically, self-compassion interventions were more efficacious in reducing anxiety in samples with mental disorders compared to these with physical illnesses. In terms of treatment delivery, there was comparable efficacy between Internet-based and face-to-face interventions. There was also a positive relationship between treatment sessions and improvement in anxiety symptoms. In addition, we found that an increased but not baseline self-compassion score was associated with better treatment outcomes. Overall, these findings provide direct implications for the management of anxiety symptoms with self-compassion interventions. • We characterized the effects of self-compassion interventions on anxiety symptoms. • Self-compassion interventions had a medium effect on anxiety for up to six months. • Number of sessions was associated with better treatment outcomes. • Self-compassion interventions largely reduced anxiety in samples with mental illness. • Increased self-compassion score was associated with better treatment outcomes. [ABSTRACT FROM AUTHOR]

Objective: To assess whether nonsurgical therapies were related with clearance of cervical infection of high‐risk human papilloma virus (hr‐HPV) or regression of mild abnormal cytology related with hr‐HPV. Methods: Until March 2023, we identified a total of 10 424 women with cervical infection of hr‐HPV and 1966 women with mild abnormal cytology related with hr‐HPV from 44 studies that met the inclusion criteria. Results: After systematically retrieving literature, we identified 2317 citations and 44 randomized controlled studies (RCT) were enrolled. Cumulative results suggested women with cervical infection of hr‐HPV might benefit from nonsurgical therapies. Both the clearance of hr‐HPV (OR: 3.83, I2 = 99%, p < 0.00001) and regression of mild abnormal cytology related with hr‐HPV (OR: 3.12, I2 = 63%, p < 0.00001) were significantly higher than control group. Subgroup analysis stratified by systematic therapy, topical therapy, traditional Chinese medicines (TCMs), and presistent hr‐HPV got consistent results. There was substantial heterogeneity between trials (I2 = 87% for clearance of hr‐HPV and 63% for regression of cytology), sensitivity analysis was performed by excluding single study one by one, and found the cumulative results were stable and dependable. Both the funnel plots for clearance of hr‐HPV and regression of abnormal cytology were asymmetrical, significant publication bias might exist. Conclusion: Nonsurgical therapies might benefit women who had a cervical infection of hr‐HPV with/without mild abnormal cytology related with hr‐HPV. Both the clearance of hr‐HPV and regression of abnormal cytology were significantly higher than control group. More studies with less heterogeneity were needed urgently to draw concrete conclusion. [ABSTRACT FROM AUTHOR]

Yu Huang,1,2 Yilian Xie,1,3 Lei Huang,1 Zhen Han1,2 1Department of Cardiovascular Surgery, Peking University Shenzhen Hospital, Guangdong, 518036, People’s Republic of China; 2Anhui Medical University, Hefei, Anhui, 230032, People’s Republic of China; 3Shantou University Medical College, Shantou, Guangdong, 515041, People’s Republic of ChinaCorrespondence: Zhen Han, Email 2498159698@qq.comPurpose: No consensus has been established on the safety and effectiveness of out-of-hospital management of Vitamin K antagonists (VKA) therapy combining portable coagulometers and telemedicine. The present meta-analysis investigated the safety and effectiveness of this hybrid anticoagulants management model.Methods: The PubMed, Embase, Cochrane, and Web of Science databases were searched for papers published before May 1, 2022. To reduce bias, only randomized controlled trials were included. RevMan 5.3 (Cochrane) software was used to evaluate and analyze clinical outcomes, including the effectiveness and safety of patient management approaches, determined by the time in the therapeutic range (TTR) and occurrence of thrombotic and bleeding events.Results: Eight studies, comprising 3853 patients, were selected. The meta-analysis showed that anticoagulant management combining portable coagulometers and telemedicine significantly improved frequency of testing (mean difference [MD]= 12.95 days; 95% CI, 8.77– 17.12; I2= 92%; P< 0.01) and TTR (MD= 9.50%; 95% CI, 3.16– 15.85; I2= 87%; P< 0.01). Thromboembolism events were reduced (RR= 0.72; 95% CI, 0.51– 1.01; I2= 0%; P= 0.05), but the results were not statistically significant. And no significant differences in major bleeding events, rehospitalization rate, mortality, or overall treatment cost existed between the two groups.Conclusion: Although the safety of remote cardiovascular disease management is not superior to that of conventional outpatient anticoagulant management, it provides a more stable monitoring of coagulation status.Keywords: VKA therapy, warfarin, telemedicine, self-testing, randomized controlled studies, meta-analysis

Copyright of Die Orthopädie is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective To determine the placebo response rate in PsA randomized clinical trials (RCTs), its contributing factors and impact on the effect size of active treatments. Methods We searched multiple databases, from inception to 20 December 2020, for placebo-controlled RCTs in PsA. We used a random-effects meta-analysis to pool the response rates for the ACR20 criteria in the placebo arm, determined the risk difference for treatment vs placebo, and used meta-regression to determine the factors associated with placebo response rates. The risk of bias was assessed in duplicate. The study protocol was registered with PROSPERO: CRD42021226000. Results We included 42 RCTs (5050 patients receiving placebo) published between 2000 and 2020. The risk of bias was low in 28 trials, high in four, and with some concerns in 10. The pooled placebo response rate was 20.3% (95% CI: 18.6%, 22.1%; predicted intervals, 11.7–29.0%), with significant between-trial heterogeneity (I 2 = 56.8%, P  < 0.005). The pooled risk difference for treatment vs placebo was 27% (95% CI: 24%, 31%). In the multivariable meta-regression, there was a 15% (95% CI: 2.9%, 29.8%) increase in the odds of achieving the placebo response for each 5-year increment in publication year (P  = 0.016). In addition, the active treatment risk difference decreased for every 5-year increment in publication year (β = −0.053, 95% CI: −0.099, −0.007; P  = 0.024) but was not associated with the placebo response. Conclusion Despite increasing over time, the placebo response for ACR20 in PsA RCTs was not associated with the active treatment effect size. [ABSTRACT FROM AUTHOR]

Recent studies have found potential benefits of vitamin D in relieving pain, and the results from randomized controlled trials of vitamin D for fibromyalgia have been promising. We conducted a comprehensive systematic review and meta-analysis to evaluate the efficacy of vitamin D for treating fibromyalgia. PubMed, Web of Science, Embase, and Cochrane Library databases were systematically searched for English-language articles. Based on the inclusion and exclusion criteria, we selected only randomized controlled studies that reported vitamin D versus placebo-controlled cure for fibromyalgia. After extracting valid data, a meta-analysis was performed using Stata 12.0. The major outcome in the pooled analysis was the Fibromyalgia Impact Questionnaire and Visual Analogue Scale (VAS) changes. Five studies including 315 participants were identified. These studies found that vitamin D was effective in reducing Fibromyalgia Impact Questionnaire scores compared with those of the control group, with significant differences (weighted mean difference = −7.82, 95% confidence interval: −12.05 to −3.59, P < 0.001). However, there was no statistical difference in VAS between the two groups (weighted mean difference = −0.60, 95% confidence interval: −1.38 to 0.17, P > 0.05). Vitamin D supplementation may be an effective fibromyalgia therapeutic approach. [ABSTRACT FROM AUTHOR]

Background: There are various treatment modalities for chronic subdural hematoma (CSDH) and there is extensive debate surrounding pharmaceutical interventions. There is no consensus regarding the relative efficacy and safety of multiple treatment modalities. This study aims to investigate this issue and offer potential clinical recommendations., Methods: We searched PubMed, Web of Science, Embase and the Cochrane Library from January 2000 to May 2023 to identify randomized and nonrandomized controlled studies reporting one or more outcomes associated with the pharmacologic management of CSDH. The primary outcomes of interest included recurrence, favorable prognosis and adverse events, while the secondary outcomes included a reduction in hematoma volume and mortality. Pooled estimates, credible intervals and odds ratios were calculated for all outcomes using a fixed effects model. Confidence in network meta-analysis judgments were employed to stratify the evidential quality. This study was registered with PROSPERO: CRD42023406599., Results: The search strategy yielded 656 references; ultimately, 36 studies involving 8082 patients fulfilled our predefined inclusion criteria. The findings suggested that statins + glucocorticoids (GCs) ranked highest for preventing recurrence, improving prognosis and facilitating hematoma absorption. Tranexamic acid ranked second highest for preventing recurrence. Statins were found to be the preferred drug intervention for decreasing mortality and preventing adverse events. Antithrombotic agents ranked lowest in terms of decreasing mortality and improving prognosis., Conclusions: Our findings indicate that statins + GCs may be the most effective treatment modality for preventing recurrence, improving patient prognosis and facilitating hematoma absorption. In terms of reducing mortality and preventing adverse events, statins may be superior to other pharmacological interventions. Routine use of GCs is not suggested for patients with CSDH. Further prospective research is needed to directly compare the efficacy and superiority of various pharmaceutical interventions targeting CSDH to reinforce and validate our findings., Competing Interests: The authors declare no financial affiliations with entities that may hold vested interests in the submitted research; further, no additional associations or engagements have exerted an influence on the content of the submitted work., (© The Author(s) 2024. Published by Oxford University Press.)

The question of the possibility of the most effective drug choosing within one class from the standpoint of evidence-based medicine is considered in the article. Drugs belonging to the same class may have both great similarities and significant differences. This is demonstrated by the example of different classes of drugs (beta-blockers, angiotensin-converting enzyme inhibitors, and new oral anticoagulants). The choice of the most effective (from the standpoint of evidence-based medicine) is impossible if there are no direct comparisons in randomized controlled studies between drugs of the same class that have demonstrated their effectiveness separately. Analysis of observational studies (large databases, registers) to identify the most effective drug in a class cannot be used to solve the problem of the superiority of a drug within a class.

Chronic pain increases the risk of sleep disturbances, depression and disability. Even though medical treatments have limited value, the use of prescription-based analgesics have increased over the recent years. It is therefore important to evaluate the effect of non-pharmacological treatments. A systematic search for studies evaluating the effect of relaxation techniques on chronic pain was conducted. Randomized controlled trials were included. Significant effects on pain, or on pain and one or more secondary outcome measure, were found in 21 studies. Four studies found significant effects on secondary outcome measures only. Four studies showed no significant effects on any outcome measure. Thus, most of the studies reported that relaxation techniques reduced pain and/or secondary outcome measures. However, the included studies have evaluated effects across a wide variety of chronic pain conditions and relaxation techniques. Hence, there is a large degree of heterogeneity among the included studies. This complicates the effect evaluation and makes it difficult to draw a clear and unambiguous conclusion. Relaxation techniques are probably most effective when used through regular and continued practice. Future studies should therefore investigate long-term effects of relaxation technique interventions, evaluate the dose-response relationship and examine efficacy differences across pain conditions and interventions.

Background: In 2015, randomized controlled trials (RCT) provided high-level evidence for the efficacy of endovascular thrombectomy in selected patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation. Ever since, thrombectomy is strongly recommended for these patients and has been broadly implemented in clinical practice. Objective: To determine whether registry studies depicting real-life data provide additional information beyond RCTs. Material and methods: Literature review of RCTs and registry studies related to thrombectomy. Results: Data from registry studies on thrombectomy are important to 1. evaluate whether RCT results can be directly transferred into clinical practice, 2. comparatively describe the efficacy of thrombectomy in patient groups underrepresented in RCTs, such as older patients, 3. compare device performances and assess technical developments, and 4. determine how treatment processes and outcomes change over time. Conclusion: Beyond RCTs, registry studies are imperative for the continuous analysis and improvement of treatment processes and outcomes as well as technical devices in daily clinical practice. [ABSTRACT FROM AUTHOR]

Background: This study aims to explore the role of low-dose rivaroxaban (≤10 mg daily) for the treatment of atherosclerotic cardiovascular disease (ASCVD).Methods: PubMed, Embase and the Cochrane Library were searched for randomized controlled trials (RCTs) of low-dose rivaroxaban in patients with ASCVD including coronary artery disease (CAD) and peripheral artery disease (PAD). Literature screening, data extraction, and risk of bias assessment were carried out independently by two researchers. Hazard ratio (HR) and 95% confidence interval (CI) were calculated using random-effect models to determine risks of outcomes in ASCVD patients treated with rivaroxaban and comparators, and meta-analysis was conducted via Review Manager 5.3.5 software.Results: 3,768 records were obtained through literature search, and 9 articles representing 6 RCTs ultimately qualified for this study. The meta-analysis indicated that for patients with CAD, the addition of rivaroxaban (5 mg daily) to aspirin could significantly reduce the risk of major adverse cardiovascular events (MACEs) compared with aspirin alone (HR 0.81, 95% CI, 0.72 to 0.91, p = 0.0004, I2 = 60%, 4 studies). For PAD patients receiving rivaroxaban (5 mg daily) plus aspirin, there was no significant reduction in the risk of MACEs (HR 0.84, 95% CI, 0.63 to 1.13, p = 0.25, I2 = 74%, 2 studies); however, there was significant reduction in major adverse limb events (MALEs) (HR 0.54, 95% CI, 0.35 to 0.83, p = 0.005, one studies) and in the composite of MACEs or MALEs (HR 0.78, 95% CI, 0.64 to 0.95, p = 0.02, I2 = 66%, 2 studies) when compared with patients receiving aspirin alone. Meanwhile, rivaroxaban combined with aspirin significantly increased the risk of International Society on Thrombosis and Haemostasis (ISTH) major bleeding compared with aspirin alone in patients with CAD (HR 1.74, 95% CI, 1.43 to 2.13, p < 0.00001, I2 = 0%, 2 studies) and PAD (HR 1.47, 95% CI, 1.19 to 1.83, p = 0.0004, I2 = 0%, 2 studies).Conclusions: Compared with standard antiplatelet therapy, the addition of a 5 mg daily dose of rivaroxaban to standard antiplatelet therapy may improve cardiovascular or limb outcomes of patients with ASCVD, with an increase in major bleeding. Patients who would benefit from the addition of low-dose rivaroxaban to antiplatelet agents and appropriate dual-pathway antithrombotic strategies should be identified in clinical practice to individualize antithrombotic therapy.

Purpose To conduct a meta-analysis based on the results of prospective cohort clinical studies that compare the outcomes of minimally invasive and open transforaminal lumbar interbody fusion in surgical treatment of patients with lumbar spine degenerative disease. Material and methods Pubmed, EMBASE, ELibrary and Cochrane Library databases were searched for randomized clinical trials published from 2008 to November 2018, which compared the results of minimally invasive (MIS-TLIF) and open (O-TLIF) techniques of transforaminal interbody fusion in treating patients with degenerative diseases of the lumbar spine. For dichotomous variables, the relative risk and 95% confidence interval were calculated; in turn, a standardized difference in mean values and their 95 % confidence intervals were used for continuous variables, using the random effects model. Results This meta-analysis included 14 prospective cohort studies, three of which were randomized controlled clinical trials. The results of surgical treatment of 1,324 patients with degenerative diseases of the lumbar spine were assessed. In the MIS-TLIF group, a reliably lower level of pain in the lumbar spine (p < 0.00001), better functional status by ODI (p < 0.0001), lower number of adverse effects (p = 0.01) were verified. At the same time, the rate of fusion (p = 0.98) and of secondary surgical procedures (p = 0.52) between the compared groups had no significant differences. Conclusion The MIS-TLIF method has significantly better long-term clinical outcomes in comparison with the O-TLIF method in terms of pain relief and functional status and a lower risk of consequences. There were no statistically significant differences in the rates of interbody fusion and repeated sur gical interventions between the compared groups of respondents.

The mean age and gender distribution of patients seeking help for mental disorders have not yet been investigated systematically. Epidemiological surveys can provide data on gender distribution of disorders and an age range in which a disorder is most frequent, but do not offer data on the average help-seeking patient, and they are usually conducted by lay interviewers with non-clinical subjects. However, this information on age and gender can be simply extracted from randomized clinical trials (RCTs) in which consecutive clinical patients are included. As it can be assumed that the average patient tends to participate in a clinical trial when her/his illness severity has reached its highpoint, the mean age of patients in RCTs is a good estimator of the peak severity of a disorder. In RCTs, diagnoses are made by psychiatrists and only clinical patients fulfilling a minimum degree of severity are included. From 10.465 records found by electronic and hand search, we extracted 832 eligible RCTs with 151,336 patients with the 19 most relevant mental disorders. We provide a table with the mean age, standard deviation and gender distributions of all major mental disorders. These results can be used in scientific articles and educational materials and can help health care providers or researchers planning treatment programs. Patients can be informed about the natural course of the disorder. By determining the reasons why some disorders occur predominantly in a certain age or have an unbalanced gender distribution information the aetiology of these disorders may further be elucidated. [ABSTRACT FROM AUTHOR]

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The paper analyzes the main problems associated with randomized controlled studies in medical rehabilitation: patient selection; use of simulation devices as placebo; standardization of methods; blinding procedure. It presents methodological considerations for improving the quality of studies.

Die obstruktive Schlafapnoe (OSA) ist eine der häufigsten schlafbezogenen Atmungsstörungen. Sie betrifft 2-26 % der Gesamtbevölkerung. Die Überdruckbeatmung mittels „continuous positive airway pressure“ (CPAP) wird nach wie vor als Goldstandard in der Therapie angesehen, wobei die Evidenz anderer Behandlungsverfahren stetig wächst. Die am häufigsten durchgeführte chirurgische Therapie der OSA ist die Uvulopalatopharyngoplastik (UPPP). Bisher existiert jedoch keine systematische Übersichtsarbeit hierzu.Es wurden ein systematisches Review und eine Metaanalyse zur Erfassung des Effekts der UPPP bei Patienten mit OSA durchgeführt. Studien jedweden Designs, welche sich auf erwachsene OSA-Patienten bezogen, deren Diagnose mittels Polysomnographie oder mittels vergleichbarer Messung gestellt wurde, wurden in die Analyse einbezogen, solange eine isolierte „Standard-UPPP“ durchgeführt wurde.92 Studien wurden in das systematische Review einbezogen, 53 waren prospektiver und 36 retrospektiver Natur, 3 waren Fallberichte. 18 Studien verwendeten eine Kontrollgruppe zum Vergleich, davon waren 7 randomisiert kontrollierte Studien (RCT). Von diesen qualifizierten sich 3 für die quantitative Metaanalyse. Alle außer 2 (96,4 %) Studien konnten eine Reduktion in der Frequenz der respiratorischen Ereignisse zeigen. Die Erfolgs‑/Ansprechraten variierten zwischen 31,3 und 96 %. In den 7 Studien, die einen prä- und postoperativen Mittelwert der Epworth Sleepiness Scale (ESS) berichteten, konnte eine Reduktion der Schläfrigkeitsscores gezeigt werden. Kombiniert man die Daten der Studien, welche einen Effekt der UPPP im Vergleich mit einer Kontroll- oder unbehandelten Gruppe ausweisen, war die UPPP bezüglich einer Reduktion des Apnoe-Hypopnoe-Index (AHI) sowie des ESS gegenüber einer Kontroll- oder unbehandelten Gruppe signifikant überlegen. Verschiedene andere positive Effekte konnten bezüglich der UPPP in nicht randomisierten Studien nachgewiesen werden.Zusammenfassend reduziert die UPPP sowohl die respiratorischen Ereignisse als auch die Tagesschläfrigkeit bei erwachsenen OSA-Patienten. Die UPPP zeigte sich einer nicht-behandelten Kontrollgruppe in dieser Hinsicht überlegen. Weitere Studien sollten zur differenzierteren Erfassung des Langzeiteffekts, des Einflusses auf die kardiovaskuläre Mortalität und der Rolle der UPPP im verfügbaren Kanon der Therapien der OSA erfolgen. [ABSTRACT FROM AUTHOR]

Accumulation of medical knowledge related to diagnosis and management over the last 5-6 decades has altered the course of diseases, improved clinical outcomes and increased survival. Thus, it has become difficult for the practicing physician to evaluate the long-term effects of a particular therapy on survival of an individual patient. Further, the approach by each physician to an individual patient with the same disease is not always uniform. In an attempt to assist physicians in applying newly acquired knowledge to patients, clinical practice guidelines were introduced by various scientific societies. Guidelines assist in facilitating the translation of new research discoveries into clinical practice; however, despite the improvements over the years, there are still several issues related to guidelines that often appear 'lost in translation'. Guidelines are based on the results of randomized clinical trials, other nonrandomized studies, and expert opinion (i.e. the opinion of most members of the guideline committees). The merits and limitations of randomized clinical trials, guideline committees, and presentation of guidelines will be discussed. In addition, proposals to improve guidelines will be presented. © 2015 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

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This systematic review and meta-analysis investigated whether gonadotrophin-releasing hormone (GnRH) antagonist protocols reduce the risk of ovarian hyperstimulation syndrome (OHSS) in women with polycystic ovary syndrome undergoing IVF compared with the long agonist protocol. Searches were conducted on MEDLINE, EMBASE, Cochrane Library, National Research Register and ISI Conference Proceedings. Primary outcome was OHSS incidence. Secondary outcomes were total duration and dose of gonad- otrophin, number of oocytes retrieved and clinical pregnancy and miscarriage rates. A total of 966 women were included in nine randomized controlled trials. There was inconsistency in definition, classification of severity and reporting of the OHSS rate. There was no difference in the incidence of severe OHSS in the antagonist group compared with the long agonist group (relative risk 0.61; 95% CI 0.23 to 1.64). However, when all moderate and severe OHSS cases were pooled, the antagonist protocol was associated with significantly lower risk of OHSS (relative risk 0.60; 95% CI 0.48--0.76; P < 0.0001). A possible reduction in the incidence of severe OHSS with the GnRH antagonist protocol should be viewed with caution since the data is inconclusive. Larger randomized trials with adequate sample size and standardized definition, classification and diagnosis of OHSS remain necessary. [ABSTRACT FROM AUTHOR]

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This article provides an overview of the major findings of psychotherapy research and discusses the possible implications of these findings for substance user treatment researchers and practitioners. While the centrality of relationship for human change processes was historically understood, twentieth century research tended to see relationship and person variables as secondary to operationalized “mechanisms of action” unique to particular psychotherapies. Interestingly, recent meta-analytic investigations have uncovered the weakness of randomized controlled trials (RCT) comparison investigations that have, until recently, represented the “gold standard” for the field. There has been a resurgent interest in the “common factors” that appear to be important across many effective psychotherapies. In addition, psychiatric anthropologists have contributed important information about the problems of client noncompliance with mental health treatment that parallel quantitative investigations. Substance misuse researchers have also found that client characteristics, especially clients' readiness to engage treatment, are important to investigate. The importance of the “therapeutic alliance” and the characteristics of clients and clinicians have become central areas for study, rather than variables to be controlled or excluded. Emphasis on these factors may represent the future for research in psychotherapy and substance user treatment, especially if researchers and community practitioners can join together to overcome methodological feasibility and dissemination problems that plague effectiveness research. However, the continued attractiveness of comparative studies and treatment efficacy studies may represent longstanding epistemological assumptions and responses to economic incentives that will be difficult to challenge. [ABSTRACT FROM AUTHOR]

Abstract: Although type 2 diabetes is determined primarily by lifestyle and genes, dietary composition may affect both its development and complications. Dietary fat is of particular interest because fatty acids influence glucose metabolism by altering cell membrane function, enzyme activity, insulin signaling, and gene expression. This paper focuses on the prevention of type 2 diabetes and summarizes the epidemiologic literature on associations between types of dietary fat and diabetes risk. It also summarizes controlled feeding studies on the effects of dietary fats on metabolic mediators, such as insulin resistance. Taken together, the evidence suggests that replacing saturated fats and trans fatty acids with unsaturated (polyunsaturated and/or monounsaturated) fats has beneficial effects on insulin sensitivity and is likely to reduce risk of type 2 diabetes. Among polyunsaturated fats, linoleic acid from the n-6 series improves insulin sensitivity. On the other hand, long-chain n-3 fatty acids do not appear to improve insulin sensitivity or glucose metabolism. In dietary practice, foods rich in vegetable oils, including non-hydrogenated margarines, nuts, and seeds, should replace foods rich in saturated fats from meats and fat-rich dairy products. Consumption of partially hydrogenated fats should be minimized. Additional controlled, long-term studies are needed to improve our knowledge on the optimal proportion of different types of fats to prevent diabetes. [Copyright &y& Elsevier]

In a previous double-blind randomized controlled study, subjects with a history of temporomandibular disorder (TMD) reacted to artificial interference with more signs of TMD than did subjects with no TMD history. In the present study, we analysed the subjective reactions of these individuals on several symptom scales. Every day during the 2-week follow-up period, the subjects rated the intensity of their symptoms on 9 VAS scales (occlusal discomfort, chewing difficulties, tender teeth, fatigue in the jaws, headache, facial pain, opening difficulty, bruxism, ear symptoms). Subjects with a history of TMD and true interferences reported stronger symptoms than subjects with no TMD history and placebo interferences. The most prominent symptoms were occlusal discomfort and chewing difficulties. The difference in outcome between the groups with and without a TMD history suggests that there are individual differences in vulnerability to occlusal interferences. It is likely that the etiological role of occlusal interferences in TMD has not been correctly addressed in previous studies on artificial interferences. [ABSTRACT FROM AUTHOR]

Abstract: The provision of prescribed heroin to chronic heroin-dependent individuals failing other treatments has been supported during the last 70 years on the ground that the first goal of interventions on drug users is to keep them in treatment to protect them from criminal activities and to promote social integration. To assess heroin prescription effectiveness, we conducted a Cochrane systematic review of all relevant randomized controlled trials. We searched MEDLINE, EMBASE, CINAHL, and the Cochrane Library and contacted leading researchers for ongoing studies. We found 19 eligible studies, of which 4 met our inclusion criteria (577 patients). In 1 study, patients in the heroin arm remained in treatment longer than those in the methadone arm (n = 96, RR = 2.82, 95% CI = 1.70–4.68); in 2 studies, there was no difference; and in 1 study, patients given heroin left the study earlier than those given methadone (n = 235, RR = 0.79, 95% CI = 0.68–0.90). Heroin was more effective than methadone in refraining people from using street heroin in 2 studies (n = 96, RR = 1.10, 95% CI = 0.79–1.53; n = 51, RR = 0.33, 95% CI = 0.15–0.72). In 1 study, heroin reduced the risk of being charged (RR = 0.32, 95% CI = 0.14–0.78); 2 studies showed no difference, and another 2 studies adopted a multidomain outcome enclosing criminal offense and social functioning and found improvements with heroin + methadone over methadone only. It is unclear if heroin attracts people in treatment; those in treatment use less street heroin and are likely to have less criminal activities. This review systematizes and compares studies showing some inconsistencies between their aims, their adopted outcomes, and their conclusions drawn from results. [Copyright &y& Elsevier]

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A letter to the editor is presented in response to the article "Drug use, health and social outcomes of hard-to-treat heroin addicts receiving Supervised Injectable Opiate Treatment: Secondary outcomes from the Randomized Injectable Opioid Treatment Trial (RIOTT)" by N. Metrebian, T. Groshkowa, J. Hellier, and others which was published in a previous issue.

Background: This study aims to explore the role of low-dose rivaroxaban (≤10 mg daily) for the treatment of atherosclerotic cardiovascular disease (ASCVD). Methods: PubMed, Embase and the Cochrane Library were searched for randomized controlled trials (RCTs) of low-dose rivaroxaban in patients with ASCVD including coronary artery disease (CAD) and peripheral artery disease (PAD). Literature screening, data extraction, and risk of bias assessment were carried out independently by two researchers. Hazard ratio (HR) and 95% confidence interval (CI) were calculated using random-effect models to determine risks of outcomes in ASCVD patients treated with rivaroxaban and comparators, and meta-analysis was conducted via Review Manager 5.3.5 software. Results: 3,768 records were obtained through literature search, and 9 articles representing 6 RCTs ultimately qualified for this study. The meta-analysis indicated that for patients with CAD, the addition of rivaroxaban (5 mg daily) to aspirin could significantly reduce the risk of major adverse cardiovascular events (MACEs) compared with aspirin alone (HR 0.81, 95% CI, 0.72 to 0.91, p = 0.0004, I2 = 60%, 4 studies). For PAD patients receiving rivaroxaban (5 mg daily) plus aspirin, there was no significant reduction in the risk of MACEs (HR 0.84, 95% CI, 0.63 to 1.13, p = 0.25, I2 = 74%, 2 studies); however, there was significant reduction in major adverse limb events (MALEs) (HR 0.54, 95% CI, 0.35 to 0.83, p = 0.005, one studies) and in the composite of MACEs or MALEs (HR 0.78, 95% CI, 0.64 to 0.95, p = 0.02, I2 = 66%, 2 studies) when compared with patients receiving aspirin alone. Meanwhile, rivaroxaban combined with aspirin significantly increased the risk of International Society on Thrombosis and Haemostasis (ISTH) major bleeding compared with aspirin alone in patients with CAD (HR 1.74, 95% CI, 1.43 to 2.13, p < 0.00001, I2 = 0%, 2 studies) and PAD (HR 1.47, 95% CI, 1.19 to 1.83, p = 0.0004, I2 = 0%, 2 studies). Conclusions: Compared with standard antiplatelet therapy, the addition of a 5 mg daily dose of rivaroxaban to standard antiplatelet therapy may improve cardiovascular or limb outcomes of patients with ASCVD, with an increase in major bleeding. Patients who would benefit from the addition of low-dose rivaroxaban to antiplatelet agents and appropriate dual-pathway antithrombotic strategies should be identified in clinical practice to individualize antithrombotic therapy. [ABSTRACT FROM AUTHOR]

The Objective: Of the work was to describe the basics of a meta-analysis with features for evaluating models with fixed and random effects, to present principles for interpreting the graphical results of a meta-analysis (forest plot or blobogram) of comparative reviews of randomized clinical trials (RCTs)., Material and Methods: To illustrate the possibility of efficient use of the R software environment for meta-analysis, we used the results of RCTs of various tonsillectomy methods already published in the Cochrane Database review., Results: The article provides explanations for the calculation of effect size, heterogeneity statistic, and other meta-analysis statistics and their interpretation for evaluating RCTs and recommendations for choosing a model depending on the on the general research concept., Conclusion: The described method allows meta-analysis and gives an idea of the principles for preparing the results of clinical trials with the expectation of their subsequent use in systematic reviews and meta-analysis.

Tardive dyskinesia (TD) risk with D2/serotonin receptor antagonists or D2 receptor partial agonists (second-generation antipsychotics, SGAs) is considered significantly lower than with D2 antagonists (first-generation antipsychotics, FGAs). As some reports questioned this notion, we meta-analyzed randomized controlled studies (RCTs) to estimate the risk ratio (RR) and annualized rate ratio (RaR) of TD comparing SGAs vs. FGAs and SGAs vs. SGAs. Additionally, we calculated raw and annualized pooled TD rates for each antipsychotic. Data from 57 head-to-head RCTs, including 32 FGA and 86 SGA arms, were meta-analyzed, yielding 32 FGA-SGA pairs and 35 SGA-SGA pairs. The annualized TD incidence across FGA arms was 6.5% (95% CI: 5.3-7.8%) vs. 2.6% (95% CI: 2.0-3.1%) across SGA arms. TD risk and annualized rates were lower with SGAs vs. FGAs (RR=0.47, 95% CI: 0.39-0.57, p<0.0001, k=28; RaR=0.35, 95% CI: 0.28-0.45, p<0.0001, number-needed-to-treat, NNT=20). Meta-regression showed no FGA dose effect on FGA-SGA comparisons (Z=-1.03, p=0.30). FGA-SGA TD RaRs differed by SGA comparator (Q=21.8, df=7, p=0.003), with a significant advantage of olanzapine and aripiprazole over other non-clozapine SGAs in exploratory pairwise comparisons. SGA-SGA comparisons confirmed the olanzapine advantage vs. non-clozapine SGAs (RaR=0.66, 95% CI: 0.49-0.88, p=0.006, k=17, NNT=100). This meta-analysis confirms a clinically meaningfully lower TD risk with SGAs vs. FGAs, which is not driven by high dose FGA comparators, and documents significant differences with respect to this risk between individual SGAs., (© 2018 World Psychiatric Association.)

An inventory on the two critical dimensions that structure the Randomized Controlled Trial in Psychiatry, namely the definition of inclusion criteria for eligible patients for testing and the choice of psychometric methods of pathology assessment and its evolution during the experiment, considers the importance of increasingly numerous and precise international recommendations. Taking into account the formal constraints of industrial, questioning the cultural differences of the methodological approach of the tests, meeting the requirements of feasibility and ever increasing security, frequent cumbersome procedure often contrasts with the modest nature of the results. A better definition to include patients in randomized trials is desirable and it asks to return to the clinic studying the expectations of patients and their response to the therapeutic situation. Excessive standardization otherwise required for ensuring the objective nature of the assessment hampers the collection of original and varied clinical features of importance in the further definitions of indications. On the way to a resumption of the single case study, we can expect from qualitative methods applied to small groups of subjects, optimization principles of patient selection for the upcoming randomized trial and greater chance to address the relevant details of clinical response to the therapeutic situation. This is what has led to the discovery of psychotropic drugs and which is involved in the various modalities of the qualitative approach. For example, and beyond the exploration of clinical drug effects, the study of the experience of psychiatric inpatient care in the Healing Garden, conducted on a small group and on the basis of the narrative analysis of their experience, notes several operating thematic dimensions: a reduction in the perception of symptoms of the disease, the impression of regaining a foothold into reality, the interest of a differently perceived doctor-patient relationship, the advantage of renewed power to act and the recognition of the importance of support from others, patients recovering somehow « vitality » of touch with reality. This suggests the possibility to establish an appropriate rating scale for such a specific therapeutic situation and to provide a more accurate and efficient recruitment for a comparative objective demonstration. Moreover, this construction of meaning reinforces the therapeutic benefit of treatment in Healing Garden and offers new dimensions for research., (© L’Encéphale, Paris, 2016.)

Quetiapine has demonstrated efficacy in schizophrenia, bipolar disorder and in the treatment of specific symptom clusters such as agitation and sleep problems in mood disorders. In this review, randomized controlled studies demonstrating efficacy, safety and tolerability of quetiapine in major depressive disorder (MDD) and general anxiety disorder (GAD) are evaluated. The results show that quetiapine monotherapy and quetiapine augmentation of antidepressant treatment in MDD and GAD are efficacious for short-term and maintenance treatment at a dose range between 50 and 300 mg/day. Quetiapine appears to have a specific but overall mild side-effect profile, though, some adverse effects such as sedation and somnolence may lead to withdrawal from treatment in some patients. Overall, the available evidence suggests that there is a significant role for quetiapine in the treatment of MDD and GAD.