Lack of detail and uniformity in the reporting of adverse drug reactions in randomized controlled trials: important implications for systematic reviews

2001 ◽  
Vol 1 (S3) ◽  
Author(s):  
Yoon Kong Loke ◽  
Sheena Derry
Keyword(s):  
Randomized Controlled Trials ◽  
Adverse Drug Reactions ◽  
Systematic Reviews ◽  
Controlled Trials ◽  
Drug Reactions ◽  
Randomized Controlled

Differences in safety profiles of newly approved medications for multiple myeloma in real-world settings versus randomized controlled trials

2020 ◽  
pp. 107815522094193
Author(s):  
Eric P Borrelli ◽  
Conor G McGladrigan
Keyword(s):  
Multiple Myeloma ◽  
Randomized Controlled Trials ◽  
Adverse Drug Reactions ◽  
Malignant Neoplasm ◽  
Controlled Trials ◽  
Site Reaction ◽  
Drug Reactions ◽  
Infusion Site ◽  
Randomized Controlled ◽  
Fda Approval

Background Four new agents (elotuzumab, ixazomib, panobinostat, and daratumumab) were approved by the US Food and Drug Administration (FDA) in 2015 for the treatment of multiple myeloma. Our objective was to compare the safety profiles of these new medications in real-world settings and their randomized controlled trial(s). Material and methods An analysis was conducted of the FDA Adverse Event Reporting System (FAERS) for each drug consisting of the quarter that the drug received its FDA approval and the eight subsequent quarters. Reporting odds ratios and corresponding 95% confidence intervals were then calculated for each drug for each of the 10 most frequent adverse drug reactions. The randomized controlled trials that led to initial FDA approval for these medications were subsequently reviewed to assess the 10 most frequently reported adverse drug reactions in these trials. Results There were only two adverse drug reactions in the top 10 of both FAERS and its randomized controlled trials for elotuzumab (anaemia, diarrhoea) and for daratumumab (cough, back pain), five for ixazomib (diarrhoea, constipation, fatigue, nausea, peripheral neuropathy), and four panobinostat (diarrhoea, fatigue, nausea, constipation). Ixazomib had two adverse drug reactions with a significant reporting odds ratios greater than a 10-fold increased risk (plasma cell myeloma, peripheral neuropathy); elotuzumab had three adverse drug reactions (infusion site reaction, malignant neoplasm progression, deep vein thrombosis); daratumumab had three adverse drug reactions (infusion site reaction, bronchospasm, chills), while panobinostat had four (malignant neoplasm progression, decreased platelet count, diarrhoea, increased blood creatinine). Conclusion This analysis helps to highlight the importance of conducting postmarketing pharmacovigilance studies to better understand the potential adverse reactions of these medications.

scholarly journals Cochrane Schizophrenia Group’s Study-Based Register of Randomized Controlled Trials: Development and Content Analysis

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Farhad Shokraneh ◽  
Clive E Adams
Keyword(s):  
Content Analysis ◽  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Research Policy ◽  
Cochrane Review ◽  
Gis Mapping ◽  
Controlled Trials ◽  
Policy And Practice ◽  
Randomized Controlled ◽  
Review Team

Abstract Background Study-based registers facilitate systematic reviews through shortening the process for review team and reducing considerable waste during the review process. Such a register also provides new insights about trends of trials in a sub-specialty. This paper reports development and content analysis of Cochrane Schizophrenia Group’s Study-Based Register. Methods The randomized controlled trials were collected through systematic searches of major information sources. Data points were extracted, curated and classified in the register. We report trends using regression analyses in Microsoft Excel and we used GIS mapping (GunnMap 2) to visualize the geographical distribution of the origin of schizophrenia trials. Results Although only 17% of trials were registered, the number of reports form registered trials is steadily increasing and registered trials produce more reports. Clinical trial registers are main source of trial reports followed by sub-specialty journals. Schizophrenia trials have been published in 23 languages from 90 countries while 105 nations do not have any reported schizophrenia trials. Only 9.7% of trials were included in at least one Cochrane review. Pharmacotherapy is the main target of trials while trials targeting psychotherapy are increasing in a continuous rate. The number of people randomized in trials is on average 114 with 60 being the most frequent sample size. Conclusions Curated datasets within the register uncover new patterns in data that have implications for research, policy, and practice for testing new interventions in trials or systematic reviews.

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 Trigger Point Injections for Chronic Non-Malignant Musculoskeletal Pain: A Systematic Review

Pain Medicine ◽  
2009 ◽  
Vol 10 (1) ◽  
pp. 54-69 ◽  
Author(s):  
N. Ann Scott ◽  
Bing Guo ◽  
Pamela M. Barton ◽  
Robert D. Gerwin
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Musculoskeletal Pain ◽  
Systematic Reviews ◽  
Trigger Point ◽  
Small Sample ◽  
Controlled Trials ◽  
Safe Procedure ◽  
Randomized Controlled ◽  
Published Evidence

ABSTRACT Objective. This systematic review assessed the available published evidence on the efficacy and safety of using trigger point injection (TPI) to treat patients with chronic non-malignant musculoskeletal pain that had persisted for at least 3 months. Methods. All published systematic reviews or randomized controlled trials detailing the use of TPI in patients with chronic, non-malignant musculoskeletal pain (persisting for >3 months) were identified by systematically searching literature databases and the Websites of various health technology assessment agencies, research registers, and guidelines sites up to July 2006. Results. Although no systematic reviews were identified, 15 peer-reviewed randomized controlled trials met the inclusion criteria. However, deficiencies in reporting, small sample sizes, and marked inter-study heterogeneity precluded a definitive synthesis of the data. TPI is a safe procedure when used by clinicians with appropriate expertise and training. It relieved symptoms when used as a sole treatment for patients with chronic head, neck, shoulder, and back pain or whiplash syndrome, regardless of the injectant used, and may be a useful adjunct to intra-articular injection in the treatment of osteoarthritis pain. Although the addition of TPI to stretching exercises augments treatment outcomes, this was also true of other therapies such as ultrasound and laser. Conclusion. The efficacy of TPI is no more certain than it was a decade ago as, overall, there is no clear evidence of either benefit or ineffectiveness. The only advantage of injecting anesthetic into trigger points may be to reduce the pain of the needling process, which may not be an insignificant benefit.

scholarly journals An Overview of Systematic Reviews of Randomized Controlled Trials on Acupuncture Treating Migraine

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Xia-tian Zhang ◽  
Xin-yi Li ◽  
Chen Zhao ◽  
Ye-yin Hu ◽  
Yi-yi Lin ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Systematic Reviews ◽  
Preventive Treatment ◽  
Sham Acupuncture ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Overview Of Systematic Reviews ◽  
Meta Analyses ◽  
Pain Improvement

Objectives. To review the evidence of acupuncture for acute and preventive treatment of migraine for further awareness of the effect of acupuncture for migraine. Design. An overview of systematic reviews and meta-analyses (SR/MAs) for randomized controlled trials. Material and Methods. We searched PubMed, Embase, the Cochrane Library, China Knowledge Resource Integrated Database, VIP Chinese Journal Full Text Database, WANFANG Data, and China Biology Medicine disc from their establishment to May 27, 2018. SR/MAs of randomized controlled trials comparing the effect of the acupuncture intervention with another treatment control in migraine patients were included. Results. 428 SRs were identified, and 15 of them were included. Only 4 SR/MAs were assessed by GRADE, which showed certainty of most evidence being low or very low. Assessed by AMSTAR-2, fourteen was critically low rating overall confidence in the results, and 1 was low rating overall confidence in the results. Evidence suggested that acupuncture has a significant advantage of pain improvement, efficacy, and safety relative to blank control, sham acupuncture, or drug treatment, but some of these results are contradictory. Conclusions. We found that acupuncture on treating migraine has the advantage for pain improvement and safety, but the quality of SR/MAs of acupuncture for migraine remains to be improved.

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