scholarly journals Inclusion and Exclusion Criteria of Clinical Trials for Insomnia

2018 ◽  
Vol 7 (8) ◽  
pp. 206 ◽  
Author(s):  
Hendrikje Huls ◽  
Smedra Abdulahad ◽  
Marlou Mackus ◽  
Aurora van de Loo ◽  
Timothy Roehrs ◽  
...  
Keyword(s):  
External Validity ◽  
Patient Population ◽  
Theoretical Basis ◽  
Controlled Trials ◽  
Current Analysis ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Randomized Controlled ◽  
Insomnia Patient ◽  
Phase Ii And Iii

Randomized controlled trials (RCTs) have eligibility criteria for the inclusion of participants. Ideally, the RCT sample would be representative for the patient population that will use the drug under investigation. However, external validity may be at stake when applying too many or too restrictive eligibility criteria. The current two-part study examined (1) the currently applied eligibility criteria in Phase II and III RCTs examining sleep medication; (2) how these criteria match with the insomnia population as a whole; and (3) how inclusion rates can be changed by an adaptation of these criteria. In the first study, insomnia RCTs were screened at www.clinicaltrials.gov, and relevant eligibility criteria were identified. The second study comprised a survey among self-reported insomnia patients. It was determined to what extent RCT eligibility criteria match the characteristics of this patient population. Of the n = 519 patients that completed the survey only n = 2 (0.4%) met all eligibility criteria of current RCTs. RCT enrolment criteria are not representative for the insomnia patient population as a whole. Being less rigorous in applying upper or lower criteria limits results in a significant increase in the number of eligible patients, and increases the representativeness of RCTs for the insomnia patient population as a whole. The current analysis demonstrates that is important to thoroughly reconsider the use eligibility criteria and their inclusion ranges, and to have a theoretical basis for using them.

Examining the adherence to CONSORT guidelines and the reporting of the enrollment process in clinical oncology randomized controlled trials: A review of trials published between 2013 and 2015.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e14026-e14026
Author(s):  
Sophie Audet ◽  
Catherine Doyle ◽  
Christopher Lemieux ◽  
Julie Lemieux
Keyword(s):  
Randomized Controlled Trials ◽  
Clinical Oncology ◽  
External Validity ◽  
Flow Diagram ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Randomized Controlled ◽  
Number Needed To Screen ◽  
Number Of Patients ◽  
Enrollment Process

e14026 Background: Due to eligibility criteria, most, if not all, randomized controlled trials (RCTs) exclude patients at the outset, before randomization. Understanding which patients are excluded is important to evaluate the external validity of the results. The proportion of trials that report the entire flow diagram of patient enrollment, in accordance with the CONSORT 2010 statement, is unknown. Failure to do so makes it more difficult to discuss the generalizability of the trial findings. Methods: We performed the systematic retrieval and analysis of all phases II and III RCTs published in paper form between 2013 and 2015, in four high impact factor journals, in the field of clinical oncology. Our main objective was to determine the proportion of trials that report the number of patients assessed for eligibility before randomization. We further aimed to identify the variables that affect this reporting as well as the reasons for patient exclusion, to calculate the recruitment fraction and the number needed to screen and to determine the proportion of trials that include a discussion on the generalizability of the trial findings. Results: 462 RCTs were reviewed. Among them, 426 (92.2%) included the flow diagram in the article and 224 (48.5%) reported the number of patients assessed for eligibility. This proportion varied significantly between the journals studied, but it did not increase over time. A total of 116 (25.1%) included a discussion of generalizability. Among the trials that reported the entire enrollment process, the reason for patient exclusion could not be found in 50 (22.3%). Conclusions: There is still room for improvement in the reporting of the determinants of external validity in clinical oncology RCTs. Increasing the reporting of the enrollment process could help clinicians and health policy makers establish to whom the results of a trial apply.

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 The Effect of Acupuncture in Breast Cancer–Related Lymphoedema (BCRL): A Systematic Review and Meta-Analysis

2019 ◽  
Vol 18 ◽  
pp. 153473541986691 ◽  
Author(s):  
Tsai-Ju Chien ◽  
Chia-Yu Liu ◽  
Ching-Ju Fang
Keyword(s):  
Breast Cancer ◽  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Large Scale ◽  
Meta Analysis ◽  
Lymphatic Drainage ◽  
Controlled Trials ◽  
Breast Cancer Patients ◽  
Eligibility Criteria ◽  
Randomized Controlled

Background: Breast cancer–related lymphedema (BCRL) is hard to control. Management may include lymphatic drainage, skin care, bandaging, or even surgery. Since acupuncture has been proven to affect the neurophysiology and neuroendocrine systems, it has the potential to control BCRL. Aim: To evaluate the effect of acupuncture in BCRL in randomized controlled trials. Design: A literature search was performed, following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement and without language restrictions. Data Sources: Five databases were searched from inception tthrough September 2018. Only studies that fulfilled the eligibility criteria of evaluating the effect of acupuncture on lymphedema in breast cancer were included. The methodological quality of these trials was assessed using the Cochrane criteria, and meta-analysis software (RevMan 5.3) was used for analysis. Results: We examined 178 breast cancer patients from 6 trials. All included randomized controlled trials had medium to high quality, based on the modified Jadad scale. The systematic review showed that acupuncture is safe and has a trend to improve symptoms, but trials did not consistently measure outcomes. The meta-analysis showed that acupuncture produced no significant improvement in the extent of lymphedema as compared with the control intervention (−1.90; 95% confidence interval = −5.39 to 1.59, P = .29). None of the studies reported severe adverse events. Conclusions: Acupuncture is safe and has a trend to improve the lymphedema related to breast cancer, yet it did not significantly change arm circumference in BCRL. Future studies should include both subjective and objective measurements and large-scale studies are warranted.

scholarly journals Current Evidence on Traditional Chinese Exercise for Cancers: A Systematic Review of Randomized Controlled Trials

2020 ◽  
Vol 17 (14) ◽  
pp. 5011
Author(s):  
Yang Song ◽  
Dong Sun ◽  
Bíró István ◽  
Anand Thirupathi ◽  
Minjun Liang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Cancer Patients ◽  
Systematic Evaluation ◽  
Current Evidence ◽  
Controlled Trials ◽  
Eligibility Criteria ◽  
Randomized Controlled ◽  
Conventional Medical Treatment ◽  
Larger Sample

Traditional Chinese exercise (TCE) has gradually become one of the widespread complementary therapies for treatment and recovery of cancers. However, evidence based on the systematic evaluation of its efficacy is lacking, and there appears to be no conclusion regarding the setting of TCE interventions. The purpose of this systematic review is to summarize the current randomized controlled trials (RCTs) that outline the effects of TCE on cancer patients. Relevant studies were searched by GOOGLE SCHOLAR, SCIENCEDIRECT, and WEB OF SCIENCE using “traditional Chinese exercise” and “cancer.” Only RCTs published in peer-reviewed English journals were included. A total of 27 studies covering 1616 cancer patients satisfied the eligibility criteria for this review. Despite the methodological limitation and relatively high risk of bias possessed by some included studies, positive evidence was still detected on the effects of TCE on these cancer-related health outcomes in physical, psychological, and physiological parameters. The 60-min or 90-min course of TCE intervention for two to three times per week for 10 to 12 weeks was found to be the most common setting in these studies and has effectively benefited cancer patients. These findings add scientific support to encourage cancer patients to practice TCE during or after conventional medical treatment. Nevertheless, future well-designed RCTs with improved methodology and larger sample size on this field are much warranted for further verification.

Is intramedullary nailing better than the use of volar locking plates for fractures of the distal radius? A meta-analysis of randomized controlled trials

2016 ◽  
Vol 41 (5) ◽  
pp. 543-552 ◽  
Author(s):  
J. Wang ◽  
L. Zhang ◽  
J. Ma ◽  
Y. Yang ◽  
H. Jia ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Intramedullary Nailing ◽  
Meta Analysis ◽  
Cochrane Collaboration ◽  
Controlled Trials ◽  
Locking Plates ◽  
Distal Radial Fractures ◽  
Eligibility Criteria ◽  
Level Of Evidence ◽  
Randomized Controlled

We conducted a meta-analysis of randomized controlled trials that compared the use of intramedullary nails and volar locking plates in distal radial fractures. PubMed, EMBASE and the Cochrane Collaboration Central database were used to find randomized controlled trials that met the eligibility criteria. Two reviewers screened the studies, extracted the data, evaluated the methodological quality and analysed the data with RevMan 5.1 software. No statistically significant differences were detected in the disability of the arm, shoulder and hand and the Gartland and Werley scores, radiographic parameters, wrist range of motion, grip strength, total complication rate and incidence of tendon rupture between the two groups. However, carpal tunnel syndrome occurred less often after intramedullary nailing. The two fixation methods achieved equal clinical, functional and radiological outcomes for primary fixation of the indicated types of distal radial fractures. Level of evidence: Therapeutic/LevelI

scholarly journals External validity of randomized controlled trials in COPD

2007 ◽  
Vol 101 (6) ◽  
pp. 1313-1320 ◽  
Author(s):  
Justin Travers ◽  
Suzanne Marsh ◽  
Brent Caldwell ◽  
Mathew Williams ◽  
Sarah Aldington ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
External Validity ◽  
Controlled Trials ◽  
Randomized Controlled
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