Prevalence of Adverse Event Reporting in Adolescents and Young Adults Enrolled in Cancer Clinical Trials.

PURPOSE: Survival for adolescents and young adults (AYAs) with cancer has improved over the past few decades, and targeted approaches are needed to further improve outcomes. Limited reports suggest that AYAs tolerate cancer treatment differently than older and younger patients. Lack of adverse event (AE) data prevents the optimization of treatment regimens for AYAs by maximizing drug delivery and minimizing treatment-related toxicity. The extent to which the frequency and severity of AEs are reported for AYAs in cancer trials is unknown. METHODS: Using a retrospective, observational design we reviewed all phase II/III clinical trials published in 2021 that included cancer-directed therapy and enrolled at least one patient age 15-39 years diagnosed with one of the five common AYA cancers: breast cancer, colorectal cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, or melanoma. The primary outcome was to determine the proportion of phase II/III trials that report AEs for the AYA population. RESULTS: Of 2,540 publications identified, 182 were included in the final analysis. No studies reported AE data for AYAs separate from older adults. Given the lack of reporting of AEs by age, it was not possible to assess differences in AE frequency or severity or whether AEs were associated with differences in dose reductions, treatment delays, or discontinuation for AYAs. CONCLUSION: Reporting of AEs for AYAs with cancer is absent in the public domain. Failure to account for differences in treatment tolerance between AYAs and older adults may lead to undertreatment or overtreatment and delay progress toward further improving outcomes for AYAs.

Quality of content reporting on two major oncology media websites: OncLive and Targeted Oncology.

INTRODUCTION: Oncology media websites such as Oncology Live (OncLive) and Targeted Oncology (TargetedOnc) play an important role in the dissemination of oncology news to patients and clinicians; however, the quality of the content on these websites has not been assessed. Our study aimed to analyze content from these websites and assess financial conflicts of interest (FCOI) amongst speakers interviewed on these websites. METHODS: Articles published on OncLive and TargetedOnc during October 2021, were prospectively captured and analyzed. The primary outcome of our study was the quality of oncology news reporting in OncLive and TargetedOnc. We assessed the FCOI amongst speakers using data from Open Payments. RESULTS: We examined 196 articles (OncLive 108, TargetedOnc 88). Limitations of cited research were reported in 7% (7/105) of OncLive and zero TargetedOnc articles. Benefit and risks in absolute numbers were reported in 28% (28/99) of OncLive and 16% (7/45) of TargetedOnc articles. Independent experts were quoted in 47% (51/108) and 51% (44/86) of the OncLive and TargetedOnc articles, respectively (Table 3). Pharmaceutical executives were quoted in 18% (20/108) and 11% (10/88) of OncLive and TargetedOnc articles, respectively. No FCOI disclosures were listed or reported for any articles. The mean general payment received from industry by United States physicians was $63,861 in 2019 and $39,639 in 2020. CONCLUSION: Our study demonstrates low quality and potentially biased reporting of oncology news on OncLive and TargetedOnc. Careful safeguards, oversight and reporting of relevant FCOI are needed to maintain the quality and transparency of content being provided.

Editorial conflicts of interest related to the management of stable ischemic heart disease.

OBJECTIVE: Our study examines the association between the favorability of percutaneous coronary intervention (PCI) and/or coronary artery bypass surgery (CABG) and the presence of conflicts of interest (COIs) among authors. METHODS: We used the "Citing Articles" tool on the New England Journal of Medicine website to identify editorials on the use of PCI/CABG for stable ischemic heart disease. Authors were rated as "supportive," "neutral," or "critical" of these interventions based on the content of their editorials. COIs for each author were identified using past publications found on Scopus, PubMed, or a general internet search. RESULTS: A total of 606 articles were identified, and data were extracted from 56 of them. Among the 149 authors, 64 (43.0%) had a COI. Of these 64 authors, 19 (29.7%) disclosed their COI, while 45 (70.3%) did not. Overall, among authors with a COI, there was no association between disclosed and undisclosed COIs and the authors' view of PCI/CABG [χ2 (2, N = 64) = 1.63, p = .44]. If an author was associated with Medtronic, Abbott, or Boston Scientific, they were more likely to favor PCI/CABG if they had an undisclosed COI relative to authors who disclosed COIs [χ2 (1, N = 31) = 5.04, p = .025]. Authors publishing in a cardiology journal were more likely to view PCI/CABG favorably relative to those publishing in a general medicine journal [χ2 (2, N = 62) = 7.17, p = .028]. CONCLUSION: Editors should adopt policies to counteract the unbalancing effects that COIs have on medical opinions and evidence.

Ten years later: a review of the US 2009 institute of medicine report on conflicts of interest and solutions for further reform.

Conflicts of interest (COIs) in healthcare are increasingly discussed in the literature, yet these relationships continue to influence healthcare. Research has consistently shown that financial COIs shape prescribing practices, medical education and guideline recommendations. In 2009, the Institute of Medicine (IOM, now the National Academy of Medicine) published Conflicts of Interest in Medical Research, Practice, and Education-one of the most comprehensive reviews of empirical research on COIs in medicine. Ten years after publication of theIOM's report, we review the current state of COIs within medicine. We also provide specific recommendations for enhancing scientific integrity in medical research, practice, education and editorial practices.

Evaluation of Patient-Reported Outcome Measures of Positive Psychosocial Constructs in Children and Adolescent/Young Adults with Cancer: A Systematic Review of Measurement Properties.

Introduction: Children, adolescents, and young adults with cancer are a vulnerable population in whom improvements in psycho-oncology care would be valuable. We previously published a scoping review exploring what is known about positive psychological constructs in this population. A key finding was that evidence-based patient-reported outcome measures (PROMs) were needed to standardize psycho-oncology research. Methods: We undertook a systematic review of measurement properties focused on PROMs in the pediatric and adolescent/young adults (AYAs) with cancer populations. We searched for PROMs that measured at least 1 of 15 previously identified, key positive constructs. This systematic review followed COSMIN guidelines, considered the gold standard manual for systematic reviews of measurement properties. Results: We identified 20 (22 if proxy reports are counted separately) unique PROMs that met inclusion criteria. Of those, only five were recommended for use given the current evidence. The remainder may be used if no alternative exists. Only eight PROMs had any evidence of content validity, considered the most important psychometric property by COSMIN. Many studies were at risk of bias owing to incomplete or suboptimal methods. Discussion: Five PROMs are considered reliable for the pediatric and AYA with cancer populations. A number of PROMs require additional research to ensure their items and instructions are comprehensive, relevant, and comprehensible to children and AYAs. Given the overall lack of research, this review may be considered a starting point for the future refinement of a core set of PROMs to measure positive psychological constructs.

Electronic cigarettes and public health awareness: a cross-sectional analysis of Google search inquiries.

The number of American adults who use electronic nicotine delivery systems (ENDS) increased by 3 million people in 2018, up 38.3% from 8.1 to 11.2 million. Search data for ENDS were analyzed against relevant traits including state longitude, tobacco tax rate and national tobacco program funding. Searches increased 88% (95% CI, 70-100) over the last 5 years and peaked on 8 September 2019, after the CDC issued a warning about the link between ENDS and high-profile lung damage cases. Searches aimed at buying ENDS subsequently dropped 25% (95% CI, 20.1-29.6), while health-related ENDS searches spiked to their all-time high, increasing 22% (95% CI, -6 to 55) compared with the first half of 2019. ENDS searches are now more concentrated than 5 years ago, reversing the trend of the early 2010s, likely because certain states have passed laws to curb the use of ENDS. The public prefers searching for 'vaping' over 'e-cigarette' in a phenomenon similar to 'high fructose corn syrup' versus 'sugar'. Consequently, public policy discussions and public education campaigns need to use 'vaping' terms, and more states should enact policies that are strongly associated with lower ENDS usage, many of which we identify.

A Reliability Generalization Meta-Analysis of 17 Patient-Reported Outcome Measures for Positive Psychosocial Constructs in Children, Adolescents, and Young Adults with Cancer.

Introduction: Children, adolescents, and young adults (AYAs) with cancer are a special population who are subjected to a number of unique challenges, stressors, and barriers to high-quality psychological care. In a recent systematic review of measurement properties, we found that 5 of 18 identified patient-reported outcome measures (PROMs) had sufficient psychometric properties to justify their use. A next step is to analyze the reliability of these scale scores in a reliability-generalization meta-analysis. Methods: We conducted a systematic review of three databases for all studies reporting reliability data for previously identified PROMs. Included studies were further required to include patients with cancer, or survivors of cancer, ages 2-39. We next synthesized alpha and test-retest coefficients using best statistical practices, according to prespecified subgroups, where possible. We considered a threshold of 0.7 to represent sufficient evidence of reliability. Results: Seventy-one studies were included. Overall, reliability coefficients for scale and subscale scores exceeded 0.7. Subgroup analyses were limited by incomplete reporting and a lack of sufficient studies for each subgroup; however, where conducted, these subgroup analyses showed significant differences in the reliability of self-reports versus proxy reports and original versus adapted versions of PROMs. Discussion: We recommend better reporting of reliability data in future studies of children and AYAs with cancer. We discourage relying on historical reliability data in different samples and the reporting of only ranges of reliability coefficients for subscales. Our study suggests that significant differences in the reliability of PROMs may be associated with the PROM respondent and the version of the PROM, thus highlighting the need for further investigation.

An analysis of the evidence underpinning the national comprehensive cancer network practice guidelines.

OBJECTIVE: This study assesses the quality and completeness of systematic reviews (SRs) included by the National Comprehensive Cancer Network (NCCN) cancer screening clinical practice guidelines (CPGs). METHODS: We evaluated SRs according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) and AMSTAR-2 (A Measurement Tool to Assess systematic Reviews). RESULTS: Seven NCCN CPGs were included with 109 SRs. The mean PRISMA percent completeness of included SRs was 71 % (range 0.1-1.0). The mean AMSTAR-2 percent completeness was 56 % (range 0.05-0.99). Of the 70 SRs assessed via AMSTAR-2, 42 (60 %) received a "critically low" rating, 11 (15.7 %) received "low" ratings, and 17 (24.3 %) received "moderate". None of the SRs received a "high" rating. CONCLUSION: Lack of adherence to AMSTAR-2 and PRISMA reporting standards among the SRs included is prevalent. We suggest improved reporting of SR inclusion criteria and evaluation to bolster the reporting quality of SRs underpinning CPG recommendations.

Evaluation of spin in the abstracts of orthopedic trauma literature: A cross-sectional review.

OBJECTIVES: A cross-sectional analysis of orthopedic trauma randomized controlled trial (RCT) abstracts to assess the frequency and manifestations of spin, the misrepresentation or distortion of research findings, in orthopedic trauma clinical trials. METHODS: The top 5 orthopedic trauma journals were searched from January 1, 2012, to December 31, 2017. RCTs with nonsignificant endpoints (p > .05) were analyzed for spin in the abstract. The primary endpoint of our investigation was the frequency and type of spin. The secondary endpoint was to assess whether funding source was associated with the presence of spin. Due to the low reporting of funding sources no statistics were able to be computed for this outcome. RESULTS: Our PubMed search yielded 517 articles. Primary screening excluded 303 articles, and full text evaluation excluded an additional 161. Overall, 53 articles were included. Spin was identified in 35 of the 53 (66.0%) abstracts analyzed. Evidence of spin was found in 21 (39.6%) abstract results sections and 22 (41.5%) abstract conclusion sections. Of the 21 RCTs reporting a clinical trial registry, 3 (14.3%) had evidence of selective reporting bias. CONCLUSIONS: Orthopedic trauma RCTs from highly ranked journals with nonsignificant endpoints published from 2012 to 2017 frequently have spin in their abstracts. Abstracts with evidence of spin may influence a reader's perception of new drugs or procedures. In orthopedic trauma, the implications of spin may affect the treatment of patients with orthopedic trauma, so efforts to mitigate spin in RCT abstracts must be prioritized.

STARD Adherence in an Interventional Radiology Guideline for Diagnostic Arteriography.

Objective: To assess the quality of reporting in diagnostic accuracy studies (DAS) referenced by the Quality Improvement Guidelines for Diagnostic Arteriography and their adherence to the Standards for Reporting of Diagnostic Accuracy (STARD) statement.Materials and Methods: Citations specific to the Society of Interventional Radiology's Quality Improvement Guidelines for Diagnostic Arteriography were collected. Using the 34-item STARD checklist, two authors in a duplicate and blinded fashion documented the number of items reported per diagnostic accuracy study. Authors met, and any discrepancies were resolved in a resolution meeting.Results: Of the 26 diagnostic accuracy studies included, the mean number of STARD items reported was 17.8 (SD ± 3.1). The median adherence was 18 (IQR, 17-19) items. Ten articles were published prior to 2003, the original date of STARD publication, and 16 articles were published after 2003. The mean number of reported items for the articles published prior to STARD 2003, and after STARD 2003 was 17.4 (SD ± 2.4) and 18.1 (SD ± 3.5), respectively. There were 14 STARD items that demonstrated an adherence of < 25%, and 13 an adherence > 75%.Conclusion: The dichotomous distribution of adherence to the STARD statement by DAS investigated demonstrates that areas of deficient reporting may be present and require attention to ensure complete and transparent reporting in the future.

Identification of Evidence for Key Positive Psychological Constructs in Pediatric and Adolescent/Young Adult Patients with Cancer: A Scoping Review.

Introduction: Children and adolescents/young adults (AYAs) with cancer are a vulnerable population susceptible to numerous late effects, such as fatigue and depression, which may diminish their long-term psychological, physical, spiritual, and emotional health. A well-rounded understanding of how positive psychological constructs affect the quality of care and treatment outcomes is therefore warranted. Methods: We conducted a scoping review of 15 positive psychological constructs in children and AYAs with cancer. The primary research questions were (1) what is known about positive psychological constructs in children and AYAs with cancer; (2) what value is ascribed to these constructs by patients? Results: Two hundred seventy-six articles were included after database search and screening. These studies were mostly observational or qualitative and conducted in North America. Constructs were often poorly defined, and measurement tools used to gather data were wide ranging. Numerous factors were correlated with increased or decreased expression of certain constructs, but overall themes were difficult to identify. Similarly, patients often spoke of what increased or decreased expression of a construct, with less emphasis on what they implicitly value. Discussion: This scoping review found ample evidence for what increases or decreases expression of positive psychological constructs, but this evidence was observational and often conflicting. In the future, we recommend the development of a core set of psychological outcomes, with definitions and corresponding measurement tools. We further recommend an emphasis on randomized trials to more rigorously study how expression of constructs can be improved and what effect this has on the quality of life.

Citation bias in otolaryngology systematic reviews.

OBJECTIVE: Reproducibility of systemic reviews (SRs) can be hindered by the presence of citation bias. Citation bias may occur when authors of SRs conduct hand-searches of included study reference lists to identify additional studies. Such a practice may lead to exaggerated SR summary effects. The purpose of this paper is to examine the prevalence of hand-searching reference lists in otolaryngology SRs. METHODS: The authors searched for systematic reviews published in eight clinical otolaryngology journals using the Cochrane Library and PubMed, with the date parameter of January 1, 2008, to December 31, 2017. Two independent authors worked separately to extract data from each SR for the following elements: whether reference lists were hand-searched, other kinds of supplemental searching, PRISMA adherence, and funding source. Following extraction, the investigators met to review discrepancies and achieve consensus. RESULTS: A total of 539 systemic reviews, 502 from clinical journals and 37 from the Cochrane library, were identified. Of those SRs, 72.4% (390/539) hand-searched reference lists, including 97.3% (36/37) of Cochrane reviews. For 228 (58.5%) of the SRs that hand-searched reference lists, no other supplemental search (e.g., search of trial registries) was conducted. CONCLUSIONS: These findings indicate that hand-searching reference lists is a common practice in otolaryngology SRs. Moreover, a majority of studies at risk of citation bias did not attempt to mitigate the bias by conducting additional supplemental searches. The implication is that summary effects in otolaryngology systematic reviews may be biased toward statistically significant findings.

Evaluation of the completeness of intervention reporting in Cochrane surgical systematic reviews using the TIDieR-SR checklist: a cross-sectional study.

INTRODUCTION: Complete reporting of systematic reviews of interventions is essential to the interpretation of research findings and the reproducibility of research results. The Template for Intervention Description and Replication (TIDieR) checklist-and the version specific to systematic reviews (TIDieR-SR)-was created to provide authors and researchers an evidence-based guide for reporting trial and systematic review interventions. In this study, we apply TIDieR-SR to Cochrane systematic reviews of surgical interventions. METHODS: We searched the Cochrane Database for relevant systematic reviews. Two investigators applied inclusion/exclusion criteria to all titles/abstracts and full texts. These same investigators extracted all data in duplicate while masked to the other's data. The primary outcome was adherence to TIDieR-SR items. RESULTS: Two hundred and thirty-eight systematic reviews were included. Overall, included SRs adhered to a median of 6 (IQR 5-7) out of eight TIDieR-SR items. The item with the lowest adherence was item 7 (share intervention materials, 1/238 (0.4%). DISCUSSION: Our results are encouraging, but the generalisability of our findings is compromised by the inclusion of only Cochrane systematic reviews. Future reporting of intervention materials is likely to improve the application of effective surgical interventions in the clinical practice.

Evaluation of 'spin' in the abstracts and articles of randomized controlled trials in pain literature and general anesthesia.

Aim: To evaluate the abstracts and articles of randomized controlled trials (RCTs) in pain literature and general anesthesia for the evidence of spin. Materials & methods: Following a priori protocol, we used a PubMed search for RCTs from a 2-year period. Data extracted using the Boutron spin definition for criteria. Results: A total of 163 articles were identified as RCTs with clear primary and secondary end points. A total of 33 trials were identified with nonsignificant primary end points. An 18/33 were found to have spin (54.5%). The spin was identified in the results, title and conclusion 12/18, 3/18 and 3/18, respectively. Conclusion: Spin was found in 54% of pain RCTs. With sensitive clinical concerns, such as chronic pain, any misrepresentation of validity could prove to have significant clinical consequences.

Evaluation of Risks of Bias in Addiction Medicine Randomized Controlled Trials.

AIMS: Perhaps the most important step when designing and conducting randomized controlled trials (RCTs) in addiction is to put methodological safeguards in place to minimize the likelihood for bias to affect trial outcomes. In this study, we applied the revised Cochrane risk of bias tool (ROB 2) to RCTs of drug, alcohol or tobacco interventions. METHODS: We searched for trials published in 15 addiction medicine journals over a 7-year period. Our primary endpoint is the risk of bias of included studies. We conducted a sensitivity analysis of publicly funded trials. RESULTS: Overall, included RCTs were most often at high risk of bias per our judgments (244/487, 50.1%). However, significant proportions of included RCTs were at low risk of bias (123/487, 25.3%) or some concerns for bias (120/497, 24.6%). RCTs with behavioral modification interventions (19/44, 43.2%) and alcohol interventions (80/150, 53.3%) had the highest proportion of high-risk judgments. In a sensitivity analysis of publicly funded RCTs), 195/386 (50.5%) were at high risk of bias. CONCLUSIONS: Approximately half of included drug, alcohol or tobacco RCTs in our sample were judged to be at high risk of bias with the most common reason being a lack of proper blinding or proper description of blinding. Key action items to reduce bias in future addiction RCTs include adequate randomization, blinding and inclusion of a trial registry number and protocol.