From Quality of Publication to Quality of Care: Translating Trials to Practice

Results from randomized controlled trials (RCTs) can have an immediate impact on patient care. Accurate and complete reporting is essential to determine whether trial design, conduct, and analyses are scientifically creditable. Consolidated Standards of Reporting Trials (CONSORT) require explicit reporting of specific components of trial methodology necessary to allow readers to accurately assess trial validity ( 1–3 ). Trial information should also be informative, allowing readers to determine whether the results are able to be generalized to non-trial patients and whether the risk to benefit ratio of the intervention is medically acceptable. Although adherence to CONSORT guidelines allows reviewers, journal editors, and readers to judge the quality of trial methodology and validity of results, these guidelines do not necessarily ensure the reporting of sufficient information for quality application of treatment within the broad clinical community following trial publication. After reading the trial publication, the oncology care provider should be able to judge the credibility of the results and the risks and benefits and decide on whether to begin recommending the new treatment to patients within his or her practice. The need for clinicians to understand all trial details is especially important for trials of oncology therapeutics, which are often toxic and complex. Cancer treatment regimens may require combinations of drugs, radiation, and surgery applied in certain sequences and time frames. Treatment modifications, delays, and interruptions and supportive care measures that were specified within the protocol assure a degree of uniform application within the trial that might not be applied in broad clinical practice. Increased toxicities and reduced efficacy of new agents following trial publication may be partially explained by differences in patient populations, difference in treatment administration, and clinician experience ( 4 ). In this issue of the Journal, Duff et al. ( 5 ) describe an additional possible explanation for the lower effectiveness of treatments in clinical use relative to trial reports: a lack of description of the experimental treatment within the trial publication that might limit the replication of the protocol-specified trial intervention in clinical practice. Duff et al. identified 10 essential elements, including drug name, dose, route, cycle length, maximum number of cycles, premedication, growth factor support, dosing adjustments for hematologic and organ-specific toxicity, and monitoring parameters for response to treatment and development of toxicities ( 5 ). They reviewed the reporting of these elements in the most prominent biomedical journals that publish cancer trials. Overall, only 11% of articles reported all 10 essential elements. Less than half of the articles examined reported supportive care use, patient monitoring, and dosing modifications for organ-specific dysfunction or hematologic toxicity. The lack of information may not be as problematic as the above numbers imply. The authors acknowledge that trials that reported drug interventions that only had one mode of administration, for example, orally for pills, which totaled 6% of the reviewed publications, were considered deficient in reporting of this element if it was not explicitly addressed. In addition, such drug-specific information may be available from a variety of sources, such as oncology texts, monographs, and evidence-based standards of practice. However, as the authors point out, consistent reporting of these elements is preferable because of the rapidly changing treatment options for cancer therapy, the number of therapies successfully evaluated in RCTs that are taken up into clinical practice, and the variable experience of oncology providers with emerging treatment regimens. A growing number of publications have suggested that the quality of trial reporting is suboptimal in the areas of general methodology, adverse events, supportive care, and nonpharmacological interventions. For example, Pitrou et al. convincingly demonstrated that suboptimal reporting of adverse events continues to plague randomized trials, even after the publication of an expanded CONSORT statement that recommended reporting of harms ( 6 , 7 ). A review of surgical trials warned that better reporting of surgical RCTs is required if those studies are to meet CONSORT criteria ( 8 ). The clinical value and scientific validity of trials that compared an investigational treatment to best supportive care have been called into question ( 9 ). A review of these trials indicated that best supportive care is often inadequately described, is not consistent with validated standards, and may be substandard and/or delivered by physicians who were possibly inadequately skilled for the task ( 9 ). Because of the complexities of cancer treatments, which may involve multiple chemotherapy drugs, treatment modalities, and supportive care measures, a more detailed description of these treatment-related interventions may assist with the smoother transition of trial results into clinical practice. The lack of information in trial publications about treatment administration, monitoring, and supportive management is troubling, given the growing interest in assuring quality medical care. Standardized practice guidelines and electronic chemotherapy orders have been developed and implemented to improve the quality of care and the management of risk related to the prescription, preparation, and administration of chemotherapy ( 10–13 ). Studies have indicated that young adults treated at pediatric facilities do better than those treated at adult facilities for pediatric cancers and that the reverse is true for young adults treated for adult cancers ( 14 , 15 ). These results suggest that a degree of familiarity and consistency with treatment protocols may result in better outcomes for patients. The translation of knowledge into action would benefit from better reporting of trial-related interventions and procedures in RCTs. The CONSORT guidelines cover the elements necessary to judge the quality of a trial's evidence to support claims of efficacy, but they do not include the elements that would ensure the replication of a trial treatment protocol in the “real world.” In part because of word limits in journal articles, authors are left to determine which elements should be included in the trial publication, which may limit details about the trial intervention and will introduce variability in reporting of publications. Oncology care providers could contact trialists for more information and review research protocols to improve the translation of knowledge from research results into clinical practice. However, such a mode of information gathering is likely beyond what can be expected of the busy practicing clinician. As noted by Duff et al., it would be helpful to modify journal guidelines to ensure that key information about treatment administration, monitoring, and supportive care is provided consistently. If word limits in journal publications are limiting, the use of online appendices to report these elements or the provision of open access to trial protocols seem to be reasonable alternatives in this digital age. Thoughtful consideration of reporting trial-related procedures that could assist with turning “best evidence” to “best practice” would be worthwhile ( 16 ). Such a discussion to identify key elements would include trial methodologists and journal editors as well as health-care providers and health service experts with interest in the quality of care. Careful and consistent reporting would help to promote safe and effective clinical application of oncology therapeutics by assisting in the development and uptake of practice standards for new oncology treatments for the benefit of patients.

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