scholarly journals Unpublished rating scales: A major source of bias in randomised controlled trials of treatments for schizophrenia

2000 ◽  
Vol 176 (3) ◽  
pp. 249-252 ◽  
Author(s):  
Max Marshall ◽  
Austin Lockwood ◽  
Caroline Bradley ◽  
Clive Adams ◽  
Claire Joy ◽  
...  
Keyword(s):  
Gold Standard ◽  
Randomised Controlled Trials ◽  
Rating Scales ◽  
Significant Treatment Effect ◽  
Control Groups ◽  
Significant Treatment ◽  
Treatment Groups ◽  
Definition Of ◽  
Randomised Controlled ◽  
And Control

BackgroundA recent review suggested an association between using unpublished scales in clinical trials and finding significant results.AimsTo determine whether such an association existed in schizophrenia trials.MethodThree hundred trials were randomly selected from the Cochrane Schizophrenia Group's Register. All comparisons between treatment groups and control groups using rating scales were identified. The publication status of each scale was determined and claims of a significant treatment effect were recorded.ResultsTrials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison (relative risk 1.37 (95% C11.12–1.68)). This effect increased when a ‘gold-standard’ definition of treatment superiority was applied (RR 1.94 (95% C11.35–2.79)). In non-pharmacological trials, one-third of ‘gold-standard’ claims of treatment superiority would not have been made if published scales had been used.ConclusionsUnpublished scales are a source of bias in schizophrenia trials.

scholarly journals Effects of acupuncture on breast cancer-related lymphoedema: a systematic review and meta-analysis of randomised controlled trials

2019 ◽  
Vol 37 (1) ◽  
pp. 16-24
Author(s):  
Xinyan Zhang ◽  
Xiuli Wang ◽  
Bingyan Zhang ◽  
Sa Yang ◽  
Dongling Liu
Keyword(s):  
Breast Cancer ◽  
Elbow Joint ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Breast Cancer Treatment ◽  
Control Groups ◽  
Significant Difference ◽  
Effectiveness Index ◽  
Randomised Controlled ◽  
And Control

Objective: Breast cancer-related lymphoedema (BCRL) is a common complication after breast cancer treatment. We investigated whether acupuncture could be used to manage limb oedema in women after breast cancer surgery. Methods: The Cochrane Library, PubMed, Embase, Web of Science, CINAHL, and four Chinese databases were electronically searched for papers published through November 2017. Randomised controlled trials (RCTs) of acupuncture for BCRL were included. Results: In total, six RCTs with 318 patients were identified. The main analysis revealed a positive overall effect of acupuncture intervention on pre/post-treatment differences in the diameter of the elbow joint, reductions in upper limb lymphoedema and effectiveness index based on arm measurement data in patients with breast cancer. Two studies evaluating the outcome of acupuncture on the diameter of the elbow joint found a significant reduction in diameter between the acupuncture and control groups (weighted mean difference (WMD) 6 cm, 95% CI 5.11 to 6.89 cm; P<0.001). The same two studies investigated the effect of acupuncture on upper limb lymphoedema reduction and found a significant difference between the acupuncture and control groups (risk ratio 1.4, 95% CI 1.17 to 1.67; P<0.001). Two other studies used the effectiveness index to assess the arm and found a significant difference between the acupuncture and control groups (WMD 23.34, 95% CI 10.74 to 35.94; P<0.001). The fifth study used bioelectrical impedance spectroscopy to assess lymphoedema at several points on the arm before and after acupuncture; this study also reported a significant reduction in lymphoedema. The sixth study reported no significant difference in bioimpedance between the groups. Conclusions: The present meta-analysis and systematic review suggests that acupuncture is effective at reducing BCRL in patients after breast cancer treatment.

Indicated preventive interventions for anxiety in children and adolescents: a review and meta-analysis of school based programs

2019 ◽  
Author(s):  
Siobhan Hugh-Jones ◽  
Sophie Beckett ◽  
Pavan Mallikarjun
Keyword(s):  
Meta Analysis ◽  
Child And Adolescent ◽  
Sensitivity Analyses ◽  
Cochrane Library ◽  
Control Groups ◽  
Adolescent Anxiety ◽  
School Based ◽  
Intervention Intensity ◽  
Randomised Controlled ◽  
And Control

Schools are promising sites for the delivery of prevention and early intervention programs to reduce child and adolescent anxiety. It is unclear whether universal or targeted approaches are most effective. This review and meta-analysis examines the effectiveness of school-based indicated interventions and was registered with PROSPERO [CRD42018087628].MEDLINE, EMBASE, PsycINFO and the Cochrane Library were searched for randomised controlled trials comparing indicated school programs for child and adolescent anxiety to active or inactive control groups. Twenty original studies, with 2076 participants, met the inclusion criteria and 18 were suitable for meta-analysis. Sub-group and sensitivity analyses explored intervention intensity, delivery agent and control type. A small beneficial effect was found for indicated programs compared to controls on self-reported anxiety symptoms at post-test (g = -0.28, CI = -0.50, -0.05, k= 18). The small effect was maintained at 6 (g = -0.35, CI= -0.58, -0.13, k = 9) and 12 months (g = -0.24, CI = -0.48, 0.00, k = 4). Based on two studies, &gt;12 month effects were very small (g = -0.01, CI= -0.38, 0.36). No differences were found based on intervention intensity, delivery agent and control type. There was evidence of publication bias and a relatively high risk of contamination in studies. Findings support the value of school based indicated programs for child and adolescent anxiety. Effects at 12 months outperform many universal programs. High quality, randomised controlled and pragmatic trials are needed, with attention control groups and beyond 12 month diagnostic assessments are needed.

scholarly journals Measurement of long-term outcomes in observational and randomised controlled trials

2007 ◽  
Vol 191 (S50) ◽  
pp. s78-s84 ◽  
Author(s):  
Richard Hodgson ◽  
Chris Bushe ◽  
Robert Hunter
Keyword(s):  
Gold Standard ◽  
Observational Studies ◽  
Randomised Controlled Trials ◽  
Face Validity ◽  
Controlled Trials ◽  
Experimental Paradigm ◽  
Pragmatic Trials ◽  
Long Term Outcomes ◽  
Randomised Controlled

BackgroundRandomised controlled trials (RCTs) are the gold standard for evaluating treatment efficacy. However, the outcomes of RCTs often lackclinical utility and usually do not address real-world effectivenessAimsTo review how traditional RCTs may be triangulatedwith other methodologies such as observational studies and pragmatic trials by highlighting recently reported studies, outcomes used and their respective meritsMethodLiterature review focusing on drug treatmentResultsRecently reported observational and some pragmatic studies show a degree of consistency in reported results and use outcomes that have face validity for cliniciansConclusionsNo single experimental paradigm or outcome provides the necessary data to optimise treatment of mental illness in the clinical setting

scholarly journals Pengaruh Terapi AIUEO terhadap Kemampuan Bicara Pasien Stroke yang Mengalami Afasia Motorik

2019 ◽  
Vol 1 (2) ◽  
pp. 226-235
Author(s):  
Afnijar Wahyu ◽  
Liza Wati ◽  
Murad Fajri
Keyword(s):  
Wilcoxon Test ◽  
Control Group ◽  
Stroke Patients ◽  
Control Groups ◽  
Control Group Design ◽  
Treatment Groups ◽  
Group Design ◽  
Motor Aphasia ◽  
A Value ◽  
And Control

The purpose of this study was to determine the effect of AIUEO therapy on the speech ability of stroke patients who have motor aphasia in Raja Ahmad Thabib Hospital Tanjungpinang. The research design used was quasi experiment with the Nonequivalent Control Group Design approach to 9 respondents who were divided into 9 treatment groups and 9 control groups. The results showed that there were significant differences in the functional ability of communication between the control and treatment groups with a value of p <0.05 (p = 0.007 at a = 0.05) using the Wilcoxon Test statistical test. Conclusion, the influence of AIUEO therapy on the speech ability of stroke patients with motor aphasia in the treatment and control groups at Ahmad Thabib Hospital Tanjungpinang.   Keywords: Speech Ability, Motor Aphasia Stroke, AIUEO Therapy

scholarly journals Effect of Aprotinin in Adult Respiratory Distress Syndrome

1986 ◽  
Vol 14 (4) ◽  
pp. 390-399 ◽  
Author(s):  
D. V. Tuxen ◽  
J. F. Cade
Keyword(s):  
Distress Syndrome ◽  
Controlled Study ◽  
Treatment Groups ◽  
Randomised Controlled Study ◽  
Significant Difference ◽  
Patients At Risk ◽  
Seriously Ill Patients ◽  
Randomised Controlled ◽  
And Control ◽  
Seriously Ill

The possible beneficial effect of aprotinin, a broad protease inhibitor, on the incidence and outcome of ARDS was examined in two complementary studies. In the first study, the effect of aprotinin was assessed in 147 patients admitted with multiple trauma or shock. In the 57 patients who developed ARDS, mortality was significantly less in those who had previously received aprotinin (8/20, 40%) than in those who had not (26/37, 70%). Although both treatment groups were well matched, this was a retrospective study and a second prospective, randomised, controlled study was therefore carried out. In 78 patients at risk of ARDS, there was no significant difference between treated and control patients in the incidence, duration or severity of ARDS, or in mortality or other major complications. It is concluded that aprotinin is not effective in improving any aspect of ARDS or its outcome in seriously ill patients.

scholarly journals Lack of effect of supplementation with essential fatty acids on bone mineral density in healthy pre- and postmenopausal women:two randomized controlled trials of Efacal® v. calcium alone

2000 ◽  
Vol 83 (6) ◽  
pp. 629-635 ◽  
Author(s):  
E. Joan Bassey ◽  
Julie J. Littlewood ◽  
M. Claire Rothwell ◽  
David W. Pye
Keyword(s):  
Bone Turnover ◽  
Age Groups ◽  
Group Differences ◽  
Mineral Density ◽  
Control Groups ◽  
Treatment Groups ◽  
Markers Of Bone Turnover ◽  
Total Body ◽  
Age Range ◽  
And Control

Randomized controlled trials of the effects of the dietary supplement Efacal® (Scotia Pharmaceuticals Plc, Guildford, Surrey, UK) v. Ca only on total body bone mineral density (BMD) and markers of bone turnover were conducted in healthy pre- and postmenopausal women separately. Total daily dose for 12 months for the Efacal® groups was: Ca 1·0 g, evening primrose oil 4·0 g and marine fish oil 440 mg; and for the control groups was: Ca 1·0 g. Reported compliance was better than 90 % in both age groups. For the forty-three premenopausal women (age range 25–40 years), initial mean total body BMD values were similar for Efacal® and control groups and both groups showed highly significant mean increases of about 1 %; however, there were no significant between-group differences for the changes in BMD or markers of bone turnover. For the forty-two postmenopausal women (age range 50–65 years), initial mean total body BMD values were again well-matched across treatment groups. Both Efacal® and control groups showed highly significant decreases in total body BMD of about 1 %, but again there were no significant between-group differences in total body BMD or markers of bone turnover. Possible confounding variables such as initial total body BMD were explored but had no effect on the outcome in either age group. Nail quality improved in both age groups and in both Efacal® and control groups. Again, there was no significant difference between treatment groups. No evidence was found to support a beneficial effect of Efacal® on BMD in these women.

scholarly journals Efficacy of antidepressants in treating the negative symptoms of chronic schizophrenia: meta-analysis

2010 ◽  
Vol 197 (3) ◽  
pp. 174-179 ◽  
Author(s):  
Surendra P. Singh ◽  
Vidhi Singh ◽  
Nilamadhab Kar ◽  
Kelvin Chan
Keyword(s):  
Randomised Controlled Trials ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Negative Symptoms ◽  
Rating Scales ◽  
Meta Analysis ◽  
Chronic Schizophrenia ◽  
Mean Difference ◽  
Controlled Trials ◽  
Clinical Issue ◽  
Randomised Controlled

BackgroundTreatment of negative symptoms in chronic schizophrenia continues to be a major clinical issue.AimsTo analyse the efficacy of add-on antidepressants for the treatment of negative symptoms of chronic schizophrenia.MethodSystematic review and meta-analysis of randomised controlled trials comparing the effect of antidepressants and placebo on the negative symptoms of chronic schizophrenia, measured through standardised rating scales. Outcome was measured as standardised mean difference between end-of-trial and baseline scores of negative symptoms.ResultsThere were 23 trials from 22 publications (n = 819). The antidepressants involved were selective serotonin reuptake inhibitors, mirtazapine, reboxetine, mianserin, trazodone and ritanserin; trials on other antidepressants were not available. The overall standardised mean difference was moderate (–0.48) in favour of antidepressants and subgroup analysis revealed significant responses for fluoxetine, trazodone and ritanserin.ConclusionsAntidepressants along with antipsychotics are more effective in treating the negative symptoms of schizophrenia than antipsychotics alone.

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