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Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.

ABSTRACT: BACKGROUND AND OBJECTIVES:The objective of this study was to assess the reporting of randomized clinical trials investigating procedural treatments (eg, nerve blocks, targeted drug delivery) for cancer pain, with a focus on aspects that are particularly challenging in these trials. METHODS:This article presents results from a systematic review of reporting of randomized clinical trials of procedural interventions for cancer pain. Articles were identified by searching PubMed from 1966 to June 2014. Data related to quality of reporting are presented for early (1985-2004) and late periods (2005-2014). RESULTS:A total of 35 published trials were included. Approximately two-thirds of the articles clearly indicated the level of blinding. Only 26% reported a primary outcome measure. Less than half explicitly reported the number of patients who completed the trial, and only 1 reported a method that was used to accommodate missing data. Almost one-third of articles included a responder analysis, all of which specified the definition of a responder. CONCLUSIONS:The goal of highlighting these deficiencies in reporting is to promote transparent reporting of details affecting the completion and interpretation of procedural cancer pain trials so that their quality can be more easily evaluated.

SUBMITTER: Rothstein D

PROVIDER: S-EPMC6784314 | biostudies-literature | 2017 May/Jun

REPOSITORIES: biostudies-literature

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Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.

Rothstein Daniel D Kitt Rachel A RA Smith Shannon M SM Abdi Salahadin S Engle Mitchell P MP McDermott Michael P MP Raja Srinivasa N SN Turk Dennis C DC Dworkin Robert H RH Gewandter Jennifer S JS

Regional anesthesia and pain medicine 20170501 3

<h4>Background and objectives</h4>The objective of this study was to assess the reporting of randomized clinical trials investigating procedural treatments (eg, nerve blocks, targeted drug delivery) for cancer pain, with a focus on aspects that are particularly challenging in these trials.<h4>Methods</h4>This article presents results from a systematic review of reporting of randomized clinical trials of procedural interventions for cancer pain. Articles were identified by searching PubMed from 1 ...[more]

PMID: 28085789

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Project description:Objective: The occurrence, development, and prognosis of serious adverse events (SAEs) associated with anticancer drugs in clinical trials have important guiding significance for real-world clinical applications. However, to date, there have been no studies investigating SAEs reporting in randomized clinical trials of colorectal cancer treatments. This article systematically reviewed the SAEs reporting of phase III randomized clinical trials of colorectal cancer treatments and analyzed the influencing factors. Methods: We reviewed all articles about phase III randomized clinical trials of colorectal cancer treatments published in the PubMed, Embase, Medline, and New England Journal of Medicine databases from January 1, 1993, to December 31, 2018, and searched the registration information of clinical trials via the internet sites such as "clinicaltrials.gov". We analyzed the correlation between the reported proportion (RP) of SAEs in the literature and nine elements, including the clinical trial sponsor and the publication time. Chi-square tests and binary logistic regression were used to identify the factors associated with improved SAEs reports. This study was registered on PROSPERO. Results: Of 1560 articles identified, 160 were eligible, with an RP of SAEs of 25.5% (41/160). In forty-one publications reporting SAEs, only 14.6% (6/41) described the pattern of SAEs in detail. In clinical trials sponsored by pharmaceutical companies, the RP of SAEs was significantly higher than that in those sponsored by investigators (57.6 versus 20.7%, p < 0.001). From 1993 to 2018, the RP of SAEs gradually increased (none (0/6) before 2000, 17.1% (12/70) from 2000 to 2009, and 34.5% (29/84) after 2009). The average RP of SAEs published in the New England Journal of Medicine (N Engl J Med), the Lancet, the Journal of the American Medical Association (JAMA), the Lancet Oncology (Lancet Oncol), and the Journal of Clinical Oncology (J Clin Oncol) was significantly higher than that published in other journals (31.9 versus 16.7%, p = 0.030). In the clinical trials referenced by clinical guidelines, the RP of SAEs was higher than that in non-referenced clinical trials (32.0 versus 15.9%, p = 0.023). Binary logistic regression analysis showed that pharmaceutical company sponsorship, new drug research, and sample size greater than 1000 were positive influencing factors for SAEs reporting. Conclusion: Although the RP of SAEs increased over time, SAEs reporting in clinical trials needs to be further improved. The performance, outcomes and prognosis of SAEs should be reported in detail to guide clinical practice in the real world.

Dataset Information

Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.

Publications

Reporting of Design Features and Analysis Details in Randomized Clinical Trials of Procedural Treatments for Cancer Pain: An ACTTION Systematic Review.

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