Dataset Information

Reporting of Postprotocol Therapies and Attrition in Multiple Myeloma Randomized Clinical Trials: A Systematic Review.

ABSTRACT:

Importance

A thorough understanding of the optimal role and sequence of agents for treatment of multiple myeloma (MM) requires knowledge of the use and rate of postprotocol therapies in randomized clinical trials (RCTs).

Objectives

To examine the proportion of MM RCTs that reported postprotocol therapies and, among those, the percentage of patients who received no further therapy and how treatments differed between the control and intervention arms.

Evidence review

The reporting of postprotocol therapies was systematically assessed in published MM RCTs using 3 databases (PubMed, Embase, and Cochrane Registry of Controlled Trials) for MM RCTs from January 1, 2005, to December 30, 2019. All MM RCTs were included, and all other studies, such as editorials, nonrandomized studies, and review articles, were excluded.

Findings

A total of 103 RCTs were identified (47 251 patients); of these, 45 (43.7%) reported subsequent treatments in that publication or in any subsequent publication. Trials funded by pharmaceutical companies (26 of 47 [55.3%]) were more likely to report subsequent treatments than cooperative group studies (19 of 56 [33.9%]) (χ21,103 = 4.8; P = .03). Differences were found in the treatments received between the intervention and control arms of RCTs. When data were reported, 5150 of 9351 patients (54.9%) in RCTs of newly diagnosed MM and 2197 of 4501 patients (48.8%) in RCTs of relapsed/refractory MM received any subsequent therapy.

Conclusions and relevance

Postprotocol therapies in MM RCTs are often not reported and, when they are, many patients receive no further therapy. Reporting guidelines for postprotocol therapies are needed.

SUBMITTER: Mohyuddin GR

PROVIDER: S-EPMC8082314 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveThe purpose of this study was to systematically evaluate the literature on the frequency of reporting of sociodemographic data (gender, race, ethnicity, education status, health insurance status, geographic location of residence, and socioeconomic status) among interventional clinical trials involving cochlear implant patients.Databases reviewedA systematic search was performed in PubMed, Cochrane Database of Systematic Reviews, Web of Science, and SCOPUS to identify peer reviewed research.MethodsA systematic review was performed, which included original prospective clinical trial research studies involving cochlear implantation and/or interventional trials involving cochlear implant patients. Collected data included funding type, level of evidence, race reporting, ethnicity reporting, socioeconomic status reporting, education level reporting, type of insurance, geographic location, and gender of patients.ResultsA total of 644 articles were included for review. Gender was the most reported sociodemographic factor (70% of included studies). Reporting of other data among included studies was low: educational level (6%), socioeconomic status (2%), race (1%), ethnicity (1%), insurance status (0.3%), and geography (1%). The odds of reporting gender (odds ratio [OR] = 1.51), education (OR = 1.81), and geography (OR = 2.72) increased with each subsequent publication date decade; however, this trend was not seen for reporting of race, ethnicity, socioeconomic status, or insurance. The reporting of gender was less likely to be reported in studies with the pediatric participants (OR = 0.62), level II evidence (OR = 0.14), and device programming interventional studies (OR = 0.26).ConclusionReporting of sociodemographic data, other than gender, is low among prospective clinical trials involving cochlear implant patients. The lack of reporting of this key data may limit research rigor and generalizability. Clinical researchers are advised to prospectively collect these data to promote equity in cochlear implant research and clinical care.