Objectives The National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER) cancer registry covers almost half the US population. Clinical prediction models developed using the SEER cancer registry have rapidly grown in number. We sought to characterize and examine the extent to which this body of work reflects formulaic research practices, reflected by a lack of clear objectives, substandard methods, and practices with limited scientific value. Study Design and Setting We conducted a systematic review of clinical prediction model development studies using the SEER data. MEDLINE via PubMed was searched for studies published between January 1 and August 10, 2023. Studies were included if they developed a clinical prediction model using two or more predictors from the SEER database. Data extraction covered study context, intended use, predictor characteristics, reporting guideline adherence, external validation practices, and the rationale provided for using SEER. Results Of 436 eligible studies, 94% (n = 412) had first authors affiliated with institutions in China, while 3% (n = 14) were from the United States. Developed models mostly targeted lung (11%) and breast (10%) cancers, and most focused on prognosis (87%). Cox regression was the predominant modeling approach (59%), and nomograms were the most common presentation format (77%). Reporting guideline adherence was low (13%), and study protocols were rarely mentioned (3%). Nearly one-third of models included patients’ race as a predictor (32%). Of the China-affiliated studies, only 6% reported an intended clinical setting, and 3% specified the intended country of use. Discussion of the suitability of SEER was absent in 87% of included studies. Among China-affiliated studies, 22% carried out external validation using data from China. Over a 10-year period, expanding our search strategy identified more than 4000 SEER-based prediction model studies indexed in MEDLINE, with annual output growing from 37 in 2016 to over 700 in 2023. Conclusion Access to data alone does not justify model development. Most prediction models developed using SEER lack a clearly reported rationale, defined target population, an intended clinical purpose, and fail to address whether the models produced with the SEER data are appropriate for populations outside the United States. Readers should treat SEER-based prediction model studies with appropriate skepticism until evidence of rigorous methodology and clinical relevance is demonstrated. Many studies have limited scientific value and exhibit hallmarks of formulaic research created solely to boost researcher's resume. Journals, peer reviewers, and data custodians all have a responsibility to ensure high research standards for studies exploiting widely available datasets, as the growing volume of such output places editorial and peer review systems under increasing strain.
Background and Objective Clinical trials are essential for advancing healthcare, yet they often underrepresent key populations, which can limit the applicability of findings to populations for whom interventions are intended and perpetuate inequities in the evidence base. In Canada, practical, context-specific resources to support inclusive trial design and conduct remain limited. The objective was to explore barriers, facilitators, and strategies related to equitable participation in Canadian clinical trials and to gather stakeholder input to inform development of an Inclusion, Diversity, Equity, and Accessibility (IDEA) toolkit for researchers. Objective To explore barriers, facilitators, and strategies related to equitable participation in Canadian clinical trials and to gather stakeholder input to inform development of an inclusion, diversity, equity, and accessibility (IDEA) toolkit for researchers. Methods We conducted 2 in-person qualitative focus groups with 20 stakeholders, including researchers, healthcare providers, patient partners, Indigenous representatives, and other participants with lived or professional experience relevant to clinical-trial participation. Audio recordings were transcribed and analyzed in NVivo 15 using an inductive thematic-analysis approach. Results Participants identified 5 barriers to inclusive participation: lack of trust; limited clinical-trial knowledge and health research literacy; language and communication challenges; logistical and regulatory challenges; and study burden and gatekeeping. Facilitators included community engagement, culturally relevant representation and outreach, multilingual and accessible materials, flexible and accessible trial delivery, and recruitment and retention supports. Stakeholders also identified priorities for a practical, modular Canadian IDEA toolkit. Conclusion This exploratory study identifies structural, relational, and operational factors that shape inclusive trial participation and provides context-informed priorities for an IDEA toolkit. The findings are not intended to represent all underserved communities, but they offer practical lessons that can be adapted across trial settings.
OBJECTIVE Patient-reported outcomes (PROs) for individual patients with colorectal cancer (CRC) can be interpreted by using PRO scores with thresholds for clinical importance (TCIs). This study established TCIs for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Colorectal Cancer 29 (EORTC QLQ-CR29), a widely used PRO measure (PROM) in research and practice. STUDY DESIGN AND SETTING Patients with CRC from six countries completed the EORTC QLQ-CR29. To establish TCIs, patients completed anchor questions assessing limitations in daily life, need for help and/or care, and patient and partner/family worries for each item. Diagnostic accuracy for each scale was then determined using ROC analysis, along with the sensitivity and specificity of the TCIs. RESULTS In total, 240 patients (mean age: 62.2, 53% men) completed the EORTC QLQ-CR29 and anchor items on clinical importance. Area Under the ROC (AUC), a measure of diagnostic accuracy, was 0.80 or higher for 17 of the 22 QLQ-CR29 scales, with lower values observed for urinary frequency (0.79), blood and mucus in stool (0.79), dyspareunia (0.77), stoma care problems (0.74), and sexual interest (0.66). Sensitivity and specificity values for all TCIs ranged from 0.59 to 1.00, except for the sexual interest scale with a sensitivity of 0.35. CONCLUSION TCIs for the EORTC QLQ-CR29 supporting the interpretation of absolute PROMs scores of individual patients were established. These will facilitate the use of the QLQ-CR29 in clinical practice, supporting the identification of clinically important health domains of individual patients with CRC from absolute PROM scores.
