Quality of Research on Treatment Harms in Cancer

癌症治疗危害的研究质量

• 批准号: 7287954
• 负责人: Benjamin Djulbegovic
• 金额: $ 25.67万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-28 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7287954
• 关键词: Address; Classification; Clinical; Clinical Research; Clinical Research Protocols; Clinical Trials; Data; Data Reporting; Decision Making; Equilibrium; Evaluation; Failure; Funding; Funding Agency; Goals; Healthcare; Human; Intervention; Knowledge; Malignant Neoplasms; Maps; Measures; Meta-Analysis; Methods; Morbidity - disease rate; National Cancer Institute; Outcome; Outcome Measure; Paper; Patients; Physicians; Policy Maker; Population; Protocols documentation; Public Domains; Publications; Publishing; Randomized; Randomized Controlled Trials; Recommendation; Reporting; Research; Research Personnel; Review, Systematic (PT); Risk; Role; Safety; Specific qualifier value; Standards of Weights and Measures; Testing; United States Agency for Healthcare Research and Quality; Writing; base; cancer therapy; design; improved; journal article; mortality; programs; research study

DESCRIPTION (provided by applicant): Informed decision making in health care requires a balancing of information on benefit and harms associated with treatments. If data on harms are not valid, not recorded, or suppressed in the published findings, then doctors will not have all data that are needed for optimal prescribing. Therefore, having accurate, reliable, and adequately reported data on both benefits and harms is an important research-integrity issue. The National Cancer Institute (NCI) via its cooperative group (COG) mechanism in the USA conducts the majority of the publicly funded randomized controlled trials (RCTs). Hence, we propose to evaluate a comprehensive population of RCTs conducted by the NCI-COGs to assess the adequacy of collecting and reporting data on harms. We propose to study the following specific aims related to treatment-associated harms in cancer randomized controlled trials: 1. We will determine the quality of reporting of data on harms from published reports by summarizing data on the most important quality domains related to harm. 2. We will assess the extent to which outcome reporting bias exists in the NCI-sponsored clinical research. We will measure outcome reporting bias by determining how often the assessment of harms was a priority specified in the original COG research protocols, and then comparing the protocols against the final publications. 3. We will evaluate whether investigators favored one treatment over another on the basis of simultaneous assessment of benefits and harms versus selective consideration of benefits only. The proposed research will provide the first systematic data on failures to adequately report harms in randomized clinical triasl, a significant questionable research practice. The findings will also inform considerations of research quality standards by both researchers and funding agency/policy-makers (including the NCI and the Agency for Healthcare Research and Quality, which funds systematic reviews on cancer treatments). If we find systematic inadequate reporting of treatment harms, the NCI will be able to undertake immediate corrective actions to improve methodological quality of RCTs and the standards of reporting of clinical trials it funds. Finally, the improvement of the reporting of harms would benefit physicians and above all patients, who need to understand the potential harms of the treatments they receive.

描述（由申请人提供）：医疗保健中的知情决策需要平衡与治疗相关的获益和危害信息。如果有关危害的数据无效、未记录或在已发布的发现中被抑制，那么医生将无法获得最佳处方所需的所有数据。因此，拥有准确、可靠和充分报告的获益和危害数据是一个重要的研究完整性问题。美国国家癌症研究所（NCI）通过其合作小组（COG）机制进行了大多数公共资助的随机对照试验（RCT）。因此，我们建议对NCI-COG开展的RCT的综合人群进行评价，以评估收集和报告伤害数据的充分性。我们建议在癌症随机对照试验中研究以下与治疗相关危害相关的特定目标：1。我们将通过总结与伤害相关的最重要质量领域的数据，确定已发表报告中伤害数据的报告质量。 2.我们将评估在NCI申办的临床研究中存在的结局报告偏倚的程度。我们将通过确定危害评估在原始COG研究方案中的优先级，然后将方案与最终出版物进行比较，来衡量结果报告偏倚。3.我们将评估研究者是否倾向于一种治疗而不是另一种治疗，其基础是同时评估获益和危害，而不是仅选择性地考虑获益。拟议的研究将提供第一个系统性数据，说明在随机临床试验中未能充分报告危害，这是一个重大的有问题的研究实践。这些发现还将为研究人员和资助机构/政策制定者（包括NCI和医疗保健研究和质量机构，该机构资助癌症治疗的系统性评价）对研究质量标准的考虑提供信息。如果我们发现对治疗危害的系统性报告不足，NCI将能够立即采取纠正措施，以提高RCT的方法学质量及其资助的临床试验报告标准。最后，改进危害报告将使医生受益，尤其是患者，他们需要了解他们接受的治疗的潜在危害。