Randomized Controlled Trials of Psychotherapy Quality Rating Scale

2010 ◽  
Author(s):  
James H. Kocsis ◽  
Andrew J. Gerber ◽  
Barbara Milrod ◽  
Steven P. Roose ◽  
Jacques Barber ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Rating Scale ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Quality Rating

scholarly journals Improving Power and Accuracy in Randomized Controlled Trials of Pain Treatments by Accounting for Concurrent Analgesic Use: Statistical Simulations and Analyses of Randomized Controlled Trial Data

2021 ◽  
Author(s):  
Pradeep Suri ◽  
Patrick J Heagerty ◽  
Anna Korpak ◽  
Mark P Jensen ◽  
Laura S Gold ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Pain Intensity ◽  
Rating Scale ◽  
Controlled Trial ◽  
Simulated Data ◽  
Alternative Methods ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Analytic Methods ◽  
Analgesic Use

The 0 to 10 numeric rating scale (NRS) of pain intensity is a standard outcome in randomized controlled trials (RCTs) of pain treatments. For individuals taking analgesics, there may be a disparity between 'observed' pain intensity (the NRS, irrespective of concurrent analgesic use), and 'underlying' pain intensity (what the NRS would be had concurrent analgesics not been taken). Using a contemporary causal inference framework, we compare analytic methods that can potentially account for concurrent analgesic use, first in statistical simulations, and second in analyses of real (non-simulated) data from an RCT of lumbar epidural steroid injections (LESI). The default analytic method was ignoring analgesic use, which is the most common approach in pain RCTs. Compared to ignoring analgesic use and other analytic methods, simulations showed that a quantitative pain and analgesia composite outcome based on adding 1.5 points to observed pain intensity for those who were taking an analgesic (the QPAC1.5) optimized power and minimized bias. Analyses of real RCT data supported the results of the simulations, showing greater power with analysis of the QPAC1.5 as compared to ignoring analgesic use and most other methods examined. We propose alternative methods that should be considered in the analysis of pain RCTs.

scholarly journals Cognitive training interventions and depression in mild cognitive impairment and dementia: a systematic review and meta-analysis of randomized controlled trials

2020 ◽  
Vol 49 (5) ◽  
pp. 738-747
Author(s):  
Joyce Y C Chan ◽  
Tak Kit Chan ◽  
Timothy C Y Kwok ◽  
Samuel Y S Wong ◽  
Allen T C Lee ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomized Controlled Trials ◽  
Scale Score ◽  
Cognitive Training ◽  
Rating Scale ◽  
Controlled Trials ◽  
Training Interventions ◽  
Randomized Controlled ◽  
Subgroup Analyses

Abstract Background Depression is common in people with cognitive impairment but the effect of cognitive training in the reduction of depression is still uncertain. Aims The purpose of this paper is to evaluate the effect of cognitive training interventions in the reduction of depression rating scale score in people with cognitive impairment. Methods Literature searches were conducted via OVID databases. Randomized controlled trials (RCTs) evaluated the effect of cognitive training interventions for the reduction of depression rating scale score in people with mild cognitive impairment (MCI) or dementia were included. Mean difference (MD) with 95% confidence interval (CI) was used to combine the results of Geriatric Depression Scale (GDS). Standardized mean difference (SMD) was used to combine the results of different depression rating scales. Subgroup analyses were conducted according to the types of cognitive training and severity of cognitive impairment, i.e. MCI and dementia. Results A total of 2551 people with MCI or dementia were extracted from 36 RCTs. The baseline mean score of GDS-15 was 4.83. Participants received cognitive training interventions had a significant decrease in depression rating scale score than the control group (MD of GDS-15 = -1.30, 95% CI = -2.14–−0.47; and SMD of eight depression scales was −0.54 (95% CI = −0.77–−0.31). In subgroup analyses, the effect size of computerized cognitive training and cognitive stimulation therapy were medium-to-large and statistically significant in the reduction of depression rating scale score. Conclusions Cognitive training interventions show to be a potential treatment to ameliorate depression in people with cognitive impairment.

scholarly journals The verbal, non-verbal and structural bases of functional communication abilities in aphasia

2020 ◽  
Vol 2 (2) ◽  
Author(s):  
Rahel Schumacher ◽  
Stefanie Bruehl ◽  
Ajay D Halai ◽  
Matthew A Lambon Ralph
Keyword(s):  
Randomized Controlled Trials ◽  
Language Production ◽  
Large Scale ◽  
Rating Scale ◽  
Full Range ◽  
Controlled Trials ◽  
Functional Communication ◽  
Positive Effects ◽  
Randomized Controlled ◽  
Verbal Cognition

Abstract The ability to communicate, functionally, after stroke or other types of acquired brain injury is crucial for the person involved and the people around them. Accordingly, assessment of functional communication is increasingly used in large-scale randomized controlled trials as the primary outcome measure. Despite the importance of functional communication abilities to everyday life and their centrality to the measured efficacy of aphasia interventions, there is little knowledge about how commonly used measures of functional communication relate to each other, whether they capture and grade the full range of patients’ remaining communication skills and how these abilities relate to the patients’ verbal and non-verbal impairments as well as the underpinning lesions. Going beyond language-only factors is essential given that non-verbal abilities can play a crucial role in an individual’s ability to communicate effectively. This study, based on a large sample of patients covering the full range and types of post-stroke aphasia, addressed these important, open questions. The investigation combined data from three established measures of functional communication with a thorough assessment of verbal and non-verbal cognition as well as structural neuroimaging. The key findings included: (i) due to floor or ceiling effects, the full range of patients’ functional communication abilities was not captured by a single assessment alone, limiting the utility of adopting individual tests as outcome measures in randomized controlled trials; (ii) phonological abilities were most strongly related to all measures of functional communication and (iii) non-verbal cognition was particularly crucial when language production was relatively impaired and other modes of communication were allowed, when patients rated their own communication abilities, and when carers rated patients’ basic communication abilities. Finally, in addition to lesion load being significantly related to all measures of functional communication, lesion analyses showed partially overlapping clusters in language regions for the functional communication tests. Moreover, mirroring the findings from the regression analyses, additional regions previously associated with non-verbal cognition emerged for the Scenario Test and for the Patient Communication Outcome after Stroke rating scale. In conclusion, our findings elucidated the cognitive and neural bases of functional communication abilities, which may inform future clinical practice regarding assessments and therapy. In particular, it is necessary to use more than one measure to capture the full range and multifaceted nature of patients’ functional communication abilities and a therapeutic focus on non-verbal cognition might have positive effects on this important aspect of activity and participation.

Acupuncture May Improve Quality of Life in Menopausal Women: A Meta-Analysis of Randomized Controlled Trials

2017 ◽  
Vol 25 (3) ◽  
pp. 183-190 ◽  
Author(s):  
Weihan Li ◽  
Yunyun Luo ◽  
Wenbin Fu ◽  
Rui Lei
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trials ◽  
Rating Scale ◽  
Data Extraction ◽  
Meta Analysis ◽  
Menopausal Symptoms ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Menopausal Women

Objective: This analysis aims to identify, on the basis of the results of randomized controlled trials (RCTs), whether acupuncture therapy can alleviate menopausal symptoms and promote health-related quality of life. Methods: We included RCTs that directly compared any type of acupuncture with sham acupuncture in treating menopause-related symptoms and which were published from January 1, 2010 to December 31, 2016 in 6 electronic databases. Two authors performed this work independently; ‘risk-of-bias' assessment and data extraction were also independently performed by these 2 review authors. The outcomes are presented as scores of the menopause rating scale (MRS), which represents the self-assessment of patients. Results: Six studies were included. Our analysis found that acupuncture can reduce the MRS score in menopausal women by the end of the treating period (2-3 months, on average) and even in the follow-up period (1-3 months), not only in the total score but also in each subscale score. But the grade of evidence is very low. Conclusions: Both the total score and the subgroup analysis strongly indicated that acupuncture can alleviate menopause-related symptoms. However, the evidence is not very strong. Thus, further studies about the efficiency of acupuncture on menopausal symptoms based on well-designed trials are needed.

scholarly journals Electroacupuncture is Beneficial for Primary Dysmenorrhea: The Evidence from Meta-Analysis of Randomized Controlled Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-14 ◽  
Author(s):  
Si-yi Yu ◽  
Zheng-tao Lv ◽  
Qing Zhang ◽  
Sha Yang ◽  
Xi Wu ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Rating Scale ◽  
Meta Analysis ◽  
Alternative Therapy ◽  
Controlled Trials ◽  
Primary Dysmenorrhea ◽  
Symptom Scale ◽  
Promising Alternative ◽  
Randomized Controlled ◽  
And Control

Electroacupuncture (EA) is considered to be a promising alternative therapy to relieve the menstrual pain for primary dysmenorrhea (PD), but the conclusion is controversial. Here, we conducted a systematic review and meta-analysis specifically to evaluate the clinical efficacy from randomized controlled trials (RCTs) on the use of EA in patients with PD. PubMed, Embase, ISI Web of Science, CENTRAL, CNKI, and Wanfang were searched to identify RCTs that evaluated the effectiveness of EA for PD. The outcome measurements included visual analogue scale (VAS), verbal rating scale (VRS), COX retrospective symptom scale (RSS), and the curative rate. Nine RCTs with high risk of bias were included for meta-analysis. The combined VAS 30 minutes after the completion of intervention favoured EA at SP6 when compared with EA at GB39, nonacupoints, and waiting-list groups. EA was superior to pharmacological treatment when the treatment duration lasted for three menstrual cycles, evidenced by significantly higher curative rate. No statistically significant differences between EA at SP6 and control groups were found regarding the VRS, RSS-COX1, and RSS-COX2. The findings of our study suggested that EA can provide considerable immediate analgesia effect for PD. Additional studies with rigorous design and larger sample sizes are needed.

scholarly journals Effectiveness and Safety of Botulinum Toxin Type A in Treatment of Restless Legs Syndrome: A Systematic Review and Meta-Analysis

Healthcare ◽  
2021 ◽  
Vol 9 (11) ◽  
pp. 1538
Author(s):  
Yu-Chi Su ◽  
Yao-Hong Guo ◽  
Chung-Lun Liao ◽  
Yu-Ching Lin
Keyword(s):  
Botulinum Toxin ◽  
Randomized Controlled Trials ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Botulinum Toxin Type A ◽  
Type A ◽  
Botulinum Toxin Type ◽  
Controlled Trials ◽  
Restless Legs ◽  
Randomized Controlled

Our study aimed to investigate the effectiveness and safety of botulinum toxin type A in patients with restless legs syndrome. We searched electronic databases, including PubMed, Cochrane Library, and Web of Science, up to 12 June 2021, for published articles. We enrolled randomized controlled clinical trials and non-randomized controlled studies involving patients with restless legs syndrome who were treated with botulinum toxin. Quality assessment was performed using the Cochrane risk of bias tool and Joanna Briggs Institute Critical Appraisal Checklist for Quasi-Experimental Studies. As for the results, we included four articles comprising 62 participants, two studies were randomized controlled trials. Improvement in International Restless Legs Syndrome Study Group (IRLSSG) rating scale was observed in three studies. Adverse events were temporary and self-limited. Meta-analyses were performed, including the two randomized controlled trials with 27 participants. Compared with placebo, botulinum toxin injection significantly reduced scores of IRLSSG rating scale (SMD, −0.819, 95% confidence interval [CI], −1.377 to −0.262). A total of 11.8% (95% CI, 0.7–72.4%) of patients reported at least one adverse event. In conclusion, botulinum toxin injection may relieve restless legs syndrome related symptoms. However, decisive conclusions cannot be drawn because of the small number of patients included in our meta-analysis. Large-scale, randomized controlled trials are warranted to discover the optimal dose, safety, and long-term effect of intervention with botulinum toxin type A for patients with restless legs syndrome.

scholarly journals EFFICACY AND SAFETY OF CARIPRAZINE IN ACUTE MANAGEMENT OF PSYCHIATRIC DISORDERS: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

2020 ◽  
Author(s):  
Petra ◽  
Hannah Cooper ◽  
Raafat Mishriky ◽  
Ayman Antoun Reyad
Keyword(s):  
Side Effects ◽  
Randomized Controlled Trials ◽  
Rating Scale ◽  
Meta Analysis ◽  
Mean Difference ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled ◽  
Symptom Intensity ◽  
Psychiatric Conditions

Background: Cariprazine is a new atypical antipsychotic drug approved for the treatment of schizophrenia and bipolar disorders.Methods: we searched the published randomized controlled-trials (RCT) to review cariprazine efficacy and tolerability using the databases (PubMed, EUDRACT, ClinicalTrials.gov and Cochrane Central Register of Controlled Trials) for cariprazine role in managing the following psychiatric conditions (schizophrenia, bipolar mania, bipolar depression and major depressive disorder). A meta-analysis was conducted using the identified 13 clinical trials to assess efficacy using with the outcomes: positive and negative syndrome scale (PANSS), clinical global impressions - severity of Illness (CGI-S), young mania rating scales (YMRS), Montgomery Asberg depression rating scale (MADRS) and Hamilton rating scale for depression (HAM-D). The risk of discontinuation due to adverse effects and common side effects were examined.Results: The mean difference in change from baseline for PANSS was -6.23 (95% Confidence Interval (CI) -7.18, -5.28) favoring cariprazine treatment (p<0.00001). Similarly, mean difference for CGI-S was -0.36 (95% CI -0.41, -0.30), YMRS -5.64 (95% CI - 6.86, -4.43), MADRS -1.43 (95% CI -1.88, -0.99) and HAM-D -1.52 (95% CI -2.28, -0.76). The risk ratio (RR) of discontinuing due to adverse events was 1.18 (95% CI 1.01, 1.38) meaning risk increased by 18% in cariprazine group with RR for EPS related side effects 2.82 (95% CI 2.47, 3.22) reflecting an increased risk of experiencing EPS related side effects by 182%. Cariprazine was also associated with an increased incidence of side effects such as akathisia, nausea and insomnia.Conclusion: Cariprazine demonstrates significant improvements in symptom intensity control in patients suffering from psychiatric conditions including schizophrenia, bipolar disorders and depression and is considered well-tolerated with similar rates of trials discontinuation; however, cariprazine was associated with a higher risk of EPS side effects. These findings will guide psychiatrists and pharmacists in their clinical role for supporting psychiatric patients care.

The Effect of Partly Missing Covariates on Statistical Power in Randomized Controlled Trials With Discrete-Time Survival Endpoints

Methodology ◽  
2017 ◽  
Vol 13 (2) ◽  
pp. 41-60
Author(s):  
Shahab Jolani ◽  
Maryam Safarkhani
Keyword(s):  
Randomized Controlled Trials ◽  
Discrete Time ◽  
Treatment Effect ◽  
Survival Data ◽  
Controlled Trials ◽  
Missing Covariates ◽  
Indicator Method ◽  
Imputation Methods ◽  
Randomized Controlled ◽  
Baseline Covariates

Abstract. In randomized controlled trials (RCTs), a common strategy to increase power to detect a treatment effect is adjustment for baseline covariates. However, adjustment with partly missing covariates, where complete cases are only used, is inefficient. We consider different alternatives in trials with discrete-time survival data, where subjects are measured in discrete-time intervals while they may experience an event at any point in time. The results of a Monte Carlo simulation study, as well as a case study of randomized trials in smokers with attention deficit hyperactivity disorder (ADHD), indicated that single and multiple imputation methods outperform the other methods and increase precision in estimating the treatment effect. Missing indicator method, which uses a dummy variable in the statistical model to indicate whether the value for that variable is missing and sets the same value to all missing values, is comparable to imputation methods. Nevertheless, the power level to detect the treatment effect based on missing indicator method is marginally lower than the imputation methods, particularly when the missingness depends on the outcome. In conclusion, it appears that imputation of partly missing (baseline) covariates should be preferred in the analysis of discrete-time survival data.

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