Tools to Assess the External Validity of Randomized Controlled Trials in Systematic Reviews: a Systematic Review of Measurement Properties

2021 ◽  
Author(s):  
Andres Jung ◽  
Julia Balzer ◽  
Tobias Braun ◽  
Kerstin Luedtke
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
External Validity ◽  
Measurement Properties ◽  
Controlled Trials ◽  
Measurement Instruments ◽  
Health Measurement ◽  
Quality Of Evidence ◽  
Randomized Controlled

Abstract Background: Internal and external validity are the most relevant components when critically appraising randomized controlled trials (RCTs) for systematic reviews. However, there is no gold standard to assess external validity. This might be related to the heterogeneity of terminology as well as to unclear evidence of the measurement properties of available tools. The aim of this review was to identify tools to assess the external validity of RCTs in systematic reviews and to evaluate the quality of evidence regarding their measurement properties.Methods: A two-phase systematic literature search was performed in four databases: MEDLINE via PubMed, Scopus, PsycINFO via OVID, and CINAHL via EBSCO. First, tools to assess the external validity of RCTs were identified. Second, studies aiming to investigate the measurement properties of these tools were selected. The measurement properties of each included tool were appraised using an adapted version of the COnsensus based Standards for the selection of health Measurement INstruments (COSMIN) guidelines.Results: 34 publications reporting on the development or validation of 26 included tools were included. For 62% of the included tools, there was no evidence of any measurement property. For the remaining tools, reliability was assessed most frequently. Reliability was judged as “sufficient” for three tools (very low quality of evidence). Content validity was rated as “sufficient” for one tool (moderate quality of evidence).Conclusions: Based on these results, no available tool can be fully recommended to assess the external validity of RCTs in systematic reviews. Several steps are required to overcome the identified difficulties to either adapt and validate available tools or to develop a new one. There is a need for more research for this purpose.Trial registration: Prospective registration at Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/PTG4D

scholarly journals A Comprehensive Evaluation Between Dexmedetomidine and Midazolam for Intraoperative Sedation in the Elderly: Protocol for a Systematic Review and Meta-analysis of Randomized Controlled Trials

2021 ◽  
Author(s):  
Chunxia Huang ◽  
Zunjiang Li ◽  
Yingxin Long ◽  
Dongli Li ◽  
Manhua Huang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
The Elderly ◽  
Sedative Effect ◽  
Controlled Trials ◽  
Safety And Efficacy ◽  
Quality Of Evidence ◽  
Randomized Controlled

Abstract Background: The sedative effect of intraoperative sedation in elderly surgery exerts critical influence on the prognosis. Comparison on the safety and efficacy between Dexmedetomidine and Midazolam in many clinical randomized controlled trials (RCTs) were inconsistent and suspicious. We aimed to comprehensively evaluate the safety and efficacy between Dexmedetomidine and Midazolam for intraoperative sedation in the elderly via meta-analysis and systematic reviews.Methods: RCTs regarding to the comparison of sedative effects and safety between Dexmedetomidine and Midazolam in elderly patients (aged ≥ 60 years) will be comprehensively searched from 2000.10 to 2021.05 through 4 English databases and 4 Chinese databases. After extraction in duplicate, the systematic review and meta-analysis will be performed on the primary outcomes (hemodynamic changes, sedative effect, cognitive function) and secondary outcomes (analgesic effect, surgical characteristics, complications or adverse reactions) for assessing the two therapy methods using Review manage software (Version 5.3). Sensitivity analysis will be conducted to evaluate the heterogeneity of the results, funnel plot and Egger’s test will be performed to analyze publication bias of the included studies, and test sequential analysis will be applied to assess the robustness and reliability of preliminary meta-analysis results. Finally, rating quality of evidence and strength of recommendations on the meta results will be summarized by rating quality of evidence and strength of recommendations (GRADE) approach. Discussion: This systematic review and meta-analysis will evaluate the safety and efficacy between Dexmedetomidine and Midazolam for intraoperative sedation in the elderly, it will give an insight on the application of Dexmedetomidine and Midazolam, and will provide evidences-based reference for clinical decision makings.Systematic review registration: PROSPERO (CRD42021221897).

scholarly journals Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review

2020 ◽  
Author(s):  
Verena Regauer ◽  
Eva Seckler ◽  
Martin Müller ◽  
Petra Bauer
Keyword(s):  
Physical Therapy ◽  
Randomized Controlled Trials ◽  
Outcome Measures ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Balance Disorders ◽  
Quality Of Evidence ◽  
Randomized Controlled ◽  
Therapy Interventions

Abstract Background: Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes. Methods: A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥ 65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted. Results: A total of 20 randomized and 2 non-randomized controlled trials with 1,876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms. Conclusion: To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.

Randomized controlled trials

2003 ◽  
pp. 177-202
Author(s):  
Sube Banerjee
Keyword(s):  
Randomized Controlled Trials ◽  
Case Control ◽  
Controlled Trials ◽  
History Taking ◽  
Cross Sectional ◽  
Quality Of Evidence ◽  
Laboratory Science ◽  
Randomized Controlled ◽  
Why Questions

There are three main questions in health care: ‘what is going on?’, ‘why?’ and ‘what do we do about it?’. ‘What is going on?’ forms the basis for clinical assessment including history taking, examination, and diagnosis. The question ‘why?’ underlies all aetiological research from laboratory science to epidemiology. The cross-sectional, case–control and cohort methodologies discussed in other chapters in this book provide the methodology for addressing ‘why?’ questions. However, just as medicine is more than diagnosis it also covers treatment, medical research is more than aetiology: it also necessarily extends to the evaluation of interventions. Aetiological research which cannot be translated into health benefits through new or improved interventions is at best sterile and at worse selfindulgent, begging another important question: ‘so what?’. Flawed evaluations of interventions can be even more problematic since these may harm rather than help. Intervention studies (of which randomized controlled trials (RCTs) are the most important type, on the basis of quality of evidence available from them) take aetiological insights into action and provide the best evidence upon which to found clinical practice. In this chapter we will consider some of the more important factors in the design, conduct, analysis, and interpretation of RCTs.

scholarly journals Berberine for diarrhea in children and adults: a systematic review and meta-analysis

2020 ◽  
Vol 13 ◽  
pp. 175628482096129
Author(s):  
Mingkun Yu ◽  
Xuejing Jin ◽  
Changhao Liang ◽  
Fanlong Bu ◽  
Deng Pan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Controlled Trials ◽  
Cure Rate ◽  
Control Groups ◽  
Quality Of Evidence ◽  
Randomized Controlled

Background: Diarrhea is a ubiquitous digestive system disease, leading to loss of fluid and electrolytes, and may be life-threatening, especially in children and adults who are immunosuppressed or malnourished. Berberine has a broad-spectrum antibiotic activity and is very widely used to treat diarrhea in China. No systematic review has been carried out to evaluate the evidence presented in clinical trials. The aim of this study was to assess the effectiveness and safety of berberine in diarrhea treatment among children and adults. Methods: Seven databases and two clinical trial registries were searched on 1 September 2019. Randomized controlled trials were included, where participants were diagnosed (first diagnosed) as having diarrhea according to clear diagnostic criteria. Berberine alone or in combination with Western medication as intervention were included. Subgroup analyses were conducted based on children or adults, acute or persistent diarrhea, infectious or noninfectious and treatment courses. Primary outcomes were clinical cure rate and duration of diarrhea. The GRADE tool was used to assess the quality of evidence. Results: A total of 38 randomized controlled trials were included involving 3948 participants (including 27 trials on 2702 children) were included. Compared with antibiotics, berberine plus antibiotics showed better results in both adults and in children in general, especially when given for 7 days or 3 days in acute infectious diarrhea of children. Compared with the control groups, using berberine alone or in combination with montmorillonite, probiotics, and vitamin B increased the clinical cure rate of diarrhea. The use of berberine alone or berberine combined with montmorillonite reduced the duration of hospitalization. Using berberine had significantly better laboratory indicators (isoenzyme, inflammatory factors, myocardial enzyme, and fecal trait) and fewer systemic symptoms than the no berberine groups. Overall, 22 of 27 trials on children used berberine as an enema. No deaths and serious adverse events were reported. The quality of evidence of included trials was moderate to low or very low. The impact of different dosages, frequencies and treatment durations on the outcomes was not evaluated due to insufficient number of trials. Conclusion: This review demonstrated that berberine was generally effective in improving clinical cure rates and shortening the duration of diarrhea compared with control groups. No severe adverse event was reported. However, there is still a lack of high-quality evidence for evaluating the efficacy and safety of berberine. Trial registration: PROSPERO CRD42020151001 (available from http://www.crd.york.ac.uk/PROSPERO/ ).

scholarly journals PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials

Cartilage ◽  
2020 ◽  
pp. 194760352093117 ◽  
Author(s):  
Giuseppe Filardo ◽  
Davide Previtali ◽  
Francesca Napoli ◽  
Christian Candrian ◽  
Stefano Zaffagnini ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Randomized Controlled Trials ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Quality Of Evidence ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Clinically Significant

Objective To evaluate effectiveness, in terms of patient-reported outcome measures, of platelet-rich plasma (PRP) injections for knee osteoarthritis compared to placebo and other intraarticular treatments. Design PubMed, Cochrane Library, Scopus, Embase, Web of Science, as well as the gray literature were searched on January 17, 2020. Randomized controlled trials (RCTs) comparing PRP injections with placebo or other injectable treatments, in any language, on humans, were included. Risk of bias was assessed following the Cochrane guidelines; quality of evidence was graded using the GRADE guidelines. Results Thirty-four RCTs, including 1403 knees in PRP groups and 1426 in control groups, were selected. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score favored PRP, with a statistically and clinically significant difference versus placebo at 12-month follow-up ( P = 0.02) and versus HA (hyaluronic acid) at 6-month ( P < 0.001) and 12-month ( P < 0.001) follow-ups. A clinically significant difference favoring PRP versus steroids was documented for VAS (Visual Analogue Scale) pain ( P < 0.001), KOOS (Knee Injury and Osteoarthritis Outcome Score) pain ( P < 0.001), function in daily activities ( P = 0.001), and quality of life ( P < 0.001) at 6-month follow-up. However, superiority of PRP did not reach the minimal clinically important difference for all outcomes, and quality of evidence was low. Conclusions The effect of platelet concentrates goes beyond its mere placebo effect, and PRP injections provide better results than other injectable options. This benefit increases over time, being not significant at earlier follow-ups but becoming clinically significant after 6 to 12 months. However, although substantial, the improvement remains partial and supported by low level of evidence. This finding urges further research to confirm benefits and identify the best formulation and indications for PRP injections in knee OA.

scholarly journals Compound Danshen Dripping Pill for Treating Nonproliferative Diabetic Retinopathy: A Meta-Analysis of 13 Randomized Controlled Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-10 ◽  
Author(s):  
Wenjing Huang ◽  
Qi Bao ◽  
De Jin ◽  
Fengmei Lian
Keyword(s):  
Diabetic Retinopathy ◽  
Randomized Controlled Trials ◽  
Methodological Quality ◽  
Vision Loss ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Fundus Fluorescein Angiography ◽  
Quality Of Evidence ◽  
Randomized Controlled

Objective. We assess the clinical effect of compound Danshen dripping pill (CDDP) for treating diabetic retinopathy (DR). Methods. Electronic databases were searched from January 2001 to October 2016 to locate randomized controlled trials (RCTs). Efficacy was measured as main outcome and microaneurysms, hemorrhage, exudate, vision, and fundus fluorescein angiography (FFA) were measured as second outcomes. Methodological quality for each study was evaluated, RevMan 5 software was used to assess treatment effects, and GRADE was used to rate quality of evidence. Results. We located 13 RCTs and methodological quality was evaluated as high risk. Statistics indicated CDDP for treating DR was better than controls and DR risk was reduced 64% with CDDP (RR: 0.36, P=0.68); retinal microaneurysms (MD = −4.32NO, P<0.00001); retinal hemorrhages (MD = −0.70PD, P=0.03); exudate improvements (MD = −0.09PD, P=0.79); visual changes (MD = −0.12 letter, P=0.006); FFA (RR: 0.40, P=0.003). About GRADE, quality of evidence was “low.” Conclusion. CDDP may be safe and efficacious for treating or delaying DR and may improve vision or delay vision loss.

scholarly journals Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review

2020 ◽  
Author(s):  
Verena Regauer ◽  
Eva Seckler ◽  
Martin Müller ◽  
Petra Bauer
Keyword(s):  
Physical Therapy ◽  
Randomized Controlled Trials ◽  
Outcome Measures ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Balance Disorders ◽  
Quality Of Evidence ◽  
Randomized Controlled ◽  
Therapy Interventions

Abstract Background: Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes.Methods: A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥ 65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted.Results: A total of 20 randomized and 2 non-randomized controlled trials with 1,876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms.Conclusion: To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.Trial Registration: PROSPERO 2017 CRD42017080291.

scholarly journals Physical therapy interventions for older people with vertigo, dizziness and balance disorders addressing mobility and participation: a systematic review

2020 ◽  
Author(s):  
Verena Regauer ◽  
Eva Seckler ◽  
Martin Müller ◽  
Petra Bauer
Keyword(s):  
Physical Therapy ◽  
Randomized Controlled Trials ◽  
Outcome Measures ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Balance Disorders ◽  
Quality Of Evidence ◽  
Randomized Controlled ◽  
Therapy Interventions

Abstract Background Vertigo, dizziness and balance disorders (VDB) are among the most relevant contributors to the burden of disability among older adults living in the community and associated with immobility, limitations of activities of daily living and decreased participation. The aim of this study was to identify the quality of evidence of physical therapy interventions that address mobility and participation in older patients with VDB and to characterize the used primary and secondary outcomes. Methods A systematic search via MEDLINE (PubMed), Cochrane Library, CINAHL, PEDro, forward citation tracing and hand search was conducted initially in 11/2017 and updated in 7/2019. We included individual and cluster-randomized controlled trials and trials with quasi-experimental design, published between 2007 and 2017/2019 and including individuals ≥ 65 years with VDB. Physical therapy and related interventions were reviewed with no restrictions to outcome measurement. Screening of titles, abstracts and full texts, data extraction and critical appraisal was conducted by two independent researchers. The included studies were heterogeneous in terms of interventions and outcome measures. Therefore, a narrative synthesis was conducted. Results A total of 20 randomized and 2 non-randomized controlled trials with 1,876 patients met the inclusion criteria. The included studies were heterogeneous in terms of complexity of interventions, outcome measures and methodological quality. Vestibular rehabilitation (VR) was examined in twelve studies, computer-assisted VR (CAVR) in five, Tai Chi as VR (TCVR) in three, canal repositioning manoeuvres (CRM) in one and manual therapy (MT) in one study. Mixed effects were found regarding body structure/function and activities/participation. Quality of life and/or falls were assessed, with no differences between groups. VR is with moderate quality of evidence superior to usual care to improve balance, mobility and symptoms. Conclusion To treat older individuals with VDB, VR in any variation and in addition to CRMs seems to be effective. High-quality randomized trials need to be conducted to inform clinical decision making.

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