Reporting of Clinical Trial Interventions Published in Leading Otolaryngology–Head and Neck Surgery Journals

Torgerson, Trevor; Johnson, Austin; Jellison, Samuel; Tanghetti, Margo; Langley, Jean Maria; Nguyen, Lily H. P.; Vassar, Matt

doi:10.1002/lary.28404

Cited by 12 publications

(7 citation statements)

References 27 publications

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“…Our analysis suggests that intervention reporting is quite variable in our sample of obesity trials. These results are consistent with previous research conducted in our lab in otolaryngology (12), anesthesiology (15), cardiothoracic surgery (29), and urology (30) in that we found suboptimal reporting in all fields regarding the expertise of the provider and fidelity assessment, making the determination of treatment integrity difficult. JaKa et al (31) found that 69% of obesity studies inadequately described the expertise of treatment providers.…”

Section: Discussionsupporting

confidence: 92%

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Completeness of Intervention Reporting of Clinical Trials Published in Highly Ranked Obesity Journals

Rauh

Turner

Jellison

et al. 2020

Obesity

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Objective: Randomized controlled trials (RCTs) play a crucial role in the research and advancement of medical treatment. A cross-sectional study design was utilized to analyze the completeness of intervention reporting using the Template for Intervention Description and Replication (TIDieR) checklist and to evaluate factors associated with intervention reporting. A comparison of the completeness of intervention reporting before and after the publication of TIDieR was sought. Methods: PubMed was searched for RCTs in the top 10 obesity journals per the Google h5-index. After excluding non-RCTs, 300 articles were randomly sampled. After assessing each publication for eligibility, two authors (SLR and DT) extracted data related to intervention reporting from records in an independent, masked fashion. Data were then verified and analyzed. Results: The analysis revealed that the quality of intervention reporting is quite variable. Overall, no statistically significant difference in the quality of intervention reporting before and after the release of TIDieR guidelines was found. In general, obesity research has good intervention reporting in areas such as the mode of delivery, material lists for intervention, and procedure lists. However, four main areas in which obesity researchers can improve reporting quality were determined. These include providing the expertise and background of intervention providers and providing statements regarding the assessment of fidelity of the intervention. Conclusions: Urgent intervention is warranted to improve the quality of research reporting in obesity research, which is a fundamental component of obesity management. This will likely require a unified approach from researchers, journals, and funding sources.

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Section: Discussionsupporting

confidence: 92%

“…This study was conducted in tandem with other studies that evaluated the completeness of intervention reporting across clinical specialties. Since these studies used a common methodology, these methods have also been described elsewhere (12)(13)(14)(15).…”

Section: Methodsmentioning

confidence: 99%

Completeness of Intervention Reporting of Clinical Trials Published in Highly Ranked Obesity Journals

Rauh

Turner

Jellison

et al. 2020

Obesity

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“…20 The degree to which nonpharmacological trials complied with TIDieR reporting standards, including Items 11 and 12, were comparable with our study findings. We further note similar rates of compliance with TIDieR reporting guidelines in other studies beyond SARS-CoV-2, 18,19 including otolaryngology/head and neck clinical trials, 104 diabetes 105 and acute lymphocytic leukaemia. 17…”

Section: Intervention Adherencesupporting

confidence: 72%

Clinical trials of pharmacological interventions for SARS‐CoV‐2 published in leading medical journals report adherence but not how it was assessed

Lee,

Otunla,

Brennan

et al. 2024

Brit J Clinical Pharma

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BackgroundAdherence to pharmacological interventions in clinical trials is crucial for accurate identification of beneficial and adverse outcomes. The ways in which adherence to interventions should be reported in trial publications are described in the Template for Intervention Description and Replication (TIDieR), a 12‐item extension of the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines.ObjectiveTo assess compliance with TIDieR items 11 and 12 of randomised controlled trials (RCTs) of interventions in SARS‐CoV‐2 infection published in five selected journals during 2021.MethodsWe assessed pharmacological interventions for SARS‐CoV‐2 infection reported in RCTs published in 2021 in the Annals of Internal Medicine, The BMJ, JAMA, The Lancet, and The New England Journal of Medicine for compliance with TIDieR items addressing intervention adherence (items 11 and 12). We calculated proportional adherence for pharmacological and comparator interventions where available.ResultsWe found 75 eligible RCTs. 28 (37%) reported results of SARS‐CoV‐2 vaccinations. Compliance with items 11 and 12 could be assessed in 71 of these 75. Of the 71 RCTs, 37 (52%) reported how adherence was assessed (item 11) and 70 reported adherence rates (item 12). Only one of the 71 RCTs (1.4%, 0–7.6%) fully complied with TIDieR items 11and 12.ConclusionsHalf of RCTs of SARS‐CoV‐2 pharmacological interventions published in leading medical journals in 2021 complied with reporting of how adherence assessments were made and almost none complied with both TIDieR items 11 and 12. The implications for interpretation, application, and replication of findings based on these publications warrant consideration.

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“…50 There has been extensive criticism regarding the lack of interest in surgeons in performing randomized clinical trials. [51][52][53][54][55][56] In recent years, there has been increasing evidence that the surgeon and hospital volumes and specializations play a major role in postoperative complications, mortality, and survival after cancer surgery. [57][58][59][60][61][62][63][64][65][66][67][68][69][70][71][72][73][74] Theodore Kocher, who won a Nobel prize for his work in thyroid surgery, reported a 13% mortality rate in 101 operations performed during the first 10 years of practice; later on, this rate decreased to less than 1%.…”

Section: Prognostic Factors and Treatment Decisionsmentioning

confidence: 99%

“… 50 There has been extensive criticism regarding the lack of interest in surgeons in performing randomized clinical trials. 51 52 53 54 55 56 …”

Section: The Surgeon's Influence On Prognosismentioning

confidence: 99%

Eugene Nicholas Myers' Lecture on Head and Neck Cancer, 2020: The Surgeon as a Prognostic Factor in Head and Neck Cancer Patients Undergoing Surgery*

Kowalski

2023

Int Arch Otorhinolaryngol

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This paper is a transcript of the 29th Eugene N. Myers, MD International Lecture on Head and Neck Cancer presented at the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) in 2020. By the end of the 19th century, the survival rate in treated patients was 10%. With the improvements in surgical techniques, currently, about two thirds of patients survive for > 5 years. Teamwork and progress in surgical reconstruction have led to advancements in ablative surgery; the associated adjuvant treatments have further improved the prognosis in the last 30 years. However, prospective trials are lacking; most of the accumulated knowledge is based on retrospective series and some real-world data analyses. Current knowledge on prognostic factors plays a central role in an efficient treatment decision-making process. Although the influence of most tumor- and patient-related prognostic factors in head and neck cancer cannot be changed by medical interventions, some environmental factors—including treatment, decision-making, and quality—can be modified. Ideally, treatment strategy decisions should be taken in dedicated multidisciplinary team meetings. However, evidence suggests that surgeons and hospital volume and specialization play major roles in patient survival after initial or salvage head and neck cancer treatment. The metrics of surgical quality assurance (surgical margins and nodal yield) in neck dissection have a significant impact on survival in head and neck cancer patients and can be influenced by the surgeon's expertise. Strategies proposed to improve surgical quality include continuous performance measurement, feedback, and dissemination of best practice measures.

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Reporting of Clinical Trial Interventions Published in Leading Otolaryngology–Head and Neck Surgery Journals

Cited by 12 publications

References 27 publications

Completeness of Intervention Reporting of Clinical Trials Published in Highly Ranked Obesity Journals

Completeness of Intervention Reporting of Clinical Trials Published in Highly Ranked Obesity Journals

Clinical trials of pharmacological interventions for SARS‐CoV‐2 published in leading medical journals report adherence but not how it was assessed

Eugene Nicholas Myers' Lecture on Head and Neck Cancer, 2020: The Surgeon as a Prognostic Factor in Head and Neck Cancer Patients Undergoing Surgery*

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