Phillip Staibano

Background: Human papillomavirus (HPV) vaccine effectiveness against HPV-related head and neck cancer (HNC) remains unclear. We aimed to quantify the association between HPV vaccination, oral HPV infection, and HNC.Methods: We performed a systematic review and meta-analysis that was registered in PROSPERO (CRD420261366821). We searched Medline, Embase, CINAHL, and Web of Science from January 2000 to April 2026, for studies of HPV vaccination in oral HPV infection and HNC. We assessed risk of bias (RoB) with Cochrane RoB 2.0 for randomized trials and ROBINS-I for non-randomized studies. We generated pooled risk ratios (RR) with random effects models, conducted meta-regression for effect modifiers, and evaluated the certainty of evidence using Grading of Recommendations Assessment, Development, and Evaluation (GRADE).Findings: Out of 470 unique citations, 42 studies met eligibility criteria. Twenty-three studies including 32,595 participants investigated oral HPV infection. High certainty evidence demonstrated that HPV vaccination prevented oral HPV-16/HPV-18 infection [RR: 0.16, 95% confidence interval (CI): 0.08, 0.32; absolute risk reduction (ARR): 0.9% (95% CI: 0.7%, 1%)] and moderate certainty evidence suggested that HPV vaccination prevented oral HPV-16/HPV-18 infection when there was at least 40% vaccine coverage amongst females [RR = 0.35 (95% CI: 0.21, 0.57); ARR: 1.1% (95% CI: 0.7%, 1.3%)]. Low certainty evidence from over 2 million participants suggested that HPV vaccination prevents HNC in females [RR: 0.21 (95% CI: 0.11, 0.39); ARR: 7.7/100,000 (95% CI: 6/100,000, 8.7/100,000)] and very low certainty evidence suggested that HPV vaccination may prevent HNC in males. Interpretation: HPV vaccination probably prevents oral HPV infection when at least 40% of females are vaccinated, and may reduce HNC in women. The effect of HPV vaccination to prevent HNC amongst men is uncertain: this may be secondary to the low HPV vaccination rate amongst males and is urgently troublesome since oropharyngeal cancer is rising in prevalence globally.

Introduction Creativity is important in surgery for problem-solving in the operating room and the development of surgical innovations that improve patient outcomes. However, our limited understanding of what the characteristics and competencies of the highly creative surgeon are has inhibited our ability to develop the tools, programs and interventions necessary for cultivating the creativity of surgeons. We present the protocol for the INSPIRE Study, which aims to identify the factors associated with high creative achievement in surgeons. Methods and Analysis We have designed a sequential mixed-method study, including a cohort study accompanied by qualitative semi-structured interviews. The primary objective of this study will be to identify factors associated with high creative achievement in surgeons, to be assessed through direct involvement in innovation or invention, or a top score (10 out of 10) on any domain in the Inventory of Creative Activities and Achievements questionnaire. We plan to measure 39 different personal, domain-specific, domain-general, and environmental/motivational variables, chosen based on previous literature and on exploratory grounds, to be assessed as possible factors of creative potential. Multivariable logistic regression is planned, with high creative achievement as the dependent variable and all 39 potential factors of creative potential as independent variables. Ethics and Dissemination Ethics approval from the Hamilton Integrated Research Ethics Board has been obtained and no harm is expected due to participation in this study. To facilitate knowledge translation, we plan to publish the feasibility data and results in peer-reviewed journals, and present at international surgical and creativity conferences.

Background: Cancer is a significant psychological burden for patients. Previous evidence syntheses suggest creative arts therapies (CATs) may improve psychological outcomes, but are limited by heterogeneity in intervention types, study designs, and outcomes, and the lack of a certainty of evidence assessment. Aims: We conducted a robust systematic review and meta‐analysis of current randomized trial literature to explore the efficacy of CATs in improving anxiety, depression, and quality of life in cancer patients. Methods: We searched PubMed, Embase, and PsycInfo databases for peer‐reviewed randomized trials evaluating the effectiveness of CATs against a control in patients with current cancer diagnoses. We performed pairwise random‐effects meta‐analyses of standardized mean differences (SMD) for anxiety, depression, and quality of life, stratified by time‐interval. We conducted subgroup analyses by session frequency, intervention type, treatment setting, and region. For studies not pooled quantitatively, results were qualitatively summarized. Results: 67 randomized trials with 6259 patients were included. The majority of interventions were music‐based (80.6%), multi‐session (59.7%), inpatient‐based (73.1%), and conducted in North America (29.9%). Meta‐analyses demonstrated positive effects of CATs on anxiety at < 7 days (SMD = −0.62 [95% CI −1.01, −0.24]), 4–6 weeks (−1.21 [−2.08, −0.34]), and 2–3 months (−1.19 [−2.14, −0.24]); depression at 1–3 weeks (−0.44 [−0.87, −0.00]) and 4–6 weeks (−1.14 [−1.76, −0.52]); and quality of life at 1–3 weeks (0.65 [0.05, 1.25]), 4–6 weeks (1.17 [0.02, 2.32]), 2–3 months (1.42 [0.55, 2.29]), and 4–6 months (0.42 [0.04, 0.80]. Qualitative results corroborate these findings. GRADE assessment revealed low‐to‐very‐low certainty of evidence. Conclusion: Creative arts therapies may improve anxiety, depression, and quality of life among cancer patients.

Background: Noninferiority (NI) trial designs that investigate whether an experimental intervention is no worse than the standard of care have been used increasingly in recent years. The robustness of the conclusions depends in part on the analysis population set used. In NI settings, the intention-to-treat (ITT) and per-protocol (PP) analysis sets are most common. The ITT analysis has been considered anticonservative compared with the PP analysis. Objective: This study aimed to conduct a methodological review assessing the analysis population sets used in contemporary NI trials. Methods: A comprehensive electronic search strategy will be conducted to identify studies indexed in MEDLINE, Embase, Emcare, and Cochrane CENTRAL. Studies will be included if they are NI trials published in 2024. The primary outcome is the analysis population used for the primary analysis of the trial (ITT, PP, or as-treated). Secondary outcomes include the NI margin, effect estimates, point estimates, and corresponding CIs. Analyses will be performed using descriptive statistics. Results: The comprehensive search initially identified 1209 studies, of which 403 trials were eligible for data extraction. Data extraction began in January 2025 and is expected to be completed in January 2026. Conclusions: This methodological survey of NI trials will describe the analysis population used in the primary analysis and assess factors that may be associated with each analysis method.

Objective: Alginate therapies are a promising option for managing gastroesophageal reflux (GERD), but most treatments are not recommended during pregnancy. This scoping review aimed to summarize the current outcomes research on the use of alginate therapy for treating GERD during pregnancy. Data Sources: EMBASE, MEDLINE, CINAHL, and Web of Science were searched from database inception to November 1, 2024. Reference lists of included studies were also searched. Review Methods: We included randomized controlled trials (RCTs) and non‐randomized studies evaluating alginate use in pregnant individuals with GERD. Screening and data extraction were performed by three reviewers in duplicate. Extracted data included study design, location, population, study group allocation, and clinical outcomes. Descriptive statistics were calculated using Microsoft Excel. Results: Two RCTs and two prospective cohort studies met the inclusion criteria. Of the two RCTs identified, one evaluated an alginate formulation against a proton pump inhibitor (PPI), and the other against a magnesium–aluminum antacid. Cohort studies reported investigator‐ and patient‐rated treatment success at 89.7% and 90.0%, respectively, with 92.2% of participants having symptom relief within 20 min. Similar improvements in heartburn intensity and frequency were found when comparing alginates and antacids. Few maternal adverse effects were reported, and no fetal or neonatal outcomes were related to treatment. Safety profiles of alginates were comparable to PPIs and antacids. Conclusion: Current literature on alginate therapy in pregnant women may suggest potential for symptom relief and favorable tolerability, but current evidence is limited by the few available prospective studies. Level of Evidence: N/A.

Background: Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT. Methods/design: Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50–69% modify protocol before proceeding; <50% fail to proceed. Secondary feasibility outcomes include the percentage of enrolled participants with complete data at 6 months trial follow-up (ie, ≥90% proceed; 80–89% modify protocol before proceeding; <80% fail to proceed) and the recruitment rate during the trial (ie, ≥5 patients per month to proceed; 2–4 patients per month to modify protocol before proceeding; <2 patients per month to fail to proceed). We estimate that 60 patients will be needed to achieve the primary feasibility outcome. Descriptive analysis will be conducted for feasibility outcomes. The results of our pilot study will inform the feasibility of a definitive trial, and if no major changes to our protocol are indicated, we will treat this study as a vanguard trial and enrol the 60 pilot patients into the definitive trial. Ethics and dissemination: Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals. Trial registration number: NCT06542315 , registered on 6 August 2024.