Core Outcome Set for IgE ‐mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study ‘ COMFA ’

Background: IgE‐mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. Methods: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two‐round online‐modified Delphi process followed by hybrid consensus meeting to finalize the COS. Results: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in‐person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, ‘allergic symptoms’ and ‘quality of life’ achieved consensus for inclusion as ‘core’ outcomes. Conclusion: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes

Use of fat-modified food products to change dietary fat intake of young people

Food purchasing and preparation practices were modified in two boarding high schools to increase the polyunsaturated-to-saturated fat ratio (P/S) of the diet of students by changing food products rather than attempting to change eating behaviors. During years when fat-modified products were served, the P/S of males increased by 75 percent, versus a decrease of 6 percent during control years. For females, P/S increased by 53 percent during intervention years, versus an increase of 6 percent during control years

Effects of alterations in fatty acid intake on the blood pressure of adolescents: the Exeter-Andover Project

To judge the effect on blood pressure, the ratio of polyunsaturated to saturated fatty acids (P:S) of foods served to students at two boarding high schools was modified alternately at each school for one school year. The average P:S of the diet of males increased from 0.53 to 0.93 during the intervention whereas among females it increased from 0.64 to 0.98. Comparison of repeated systolic and diastolic blood pressure measurements near the end of the school year did not demonstrate a beneficial effect of the dietary fat changes on the blood pressure of these normotensive adolescents. Compared with the blood pressure patterns during control years, the dietary intervention resulted in slightly higher systolic (+0.88 mm Hg; 95% CI -0.66, +2.42) and diastolic (+1.23 mm Hg; 95% CI = +0.04, +2.42) blood pressure readings among males. Among females the intervention resulted in slightly lower systolic (-0.54 mm Hg; 95% CI = -1.95, +0.88) and diastolic (-0.80 mm Hg (95% CI -2.18, +0.58) blood pressure readings

Effects of alterations in fatty acid intake on the blood pressure of adolescents: the Exeter-Andover Project

To judge the effect on blood pressure, the ratio of polyunsaturated to saturated fatty acids (P:S) of foods served to students at two boarding high schools was modified alternately at each school for one school year. The average P:S of the diet of males increased from 0.53 to 0.93 during the intervention whereas among females it increased from 0.64 to 0.98. Comparison of repeated systolic and diastolic blood pressure measurements near the end of the school year did not demonstrate a beneficial effect of the dietary fat changes on the blood pressure of these normotensive adolescents. Compared with the blood pressure patterns during control years, the dietary intervention resulted in slightly higher systolic (+0.88 mm Hg; 95% CI -0.66, +2.42) and diastolic (+1.23 mm Hg; 95% CI = +0.04, +2.42) blood pressure readings among males. Among females the intervention resulted in slightly lower systolic (-0.54 mm Hg; 95% CI = -1.95, +0.88) and diastolic (-0.80 mm Hg (95% CI -2.18, +0.58) blood pressure readings

Effects on blood pressure of a decrease in sodium use in institutional food preparation: the Exeter-Andover Project

To judge the effect on blood pressure, sodium intake of students at two boarding high schools was reduced by 15-20% through changes in food purchasing and in preparation practices in the schools\u27 kitchens. Students were not asked to change their usual eating habits. Each school served alternately as the control or intervention school for one school year. Blood pressure was monitored among 341 subjects during control years and 309 subjects during intervention years. Analysis of blood pressure differences between early in the school year and near the end of the school year, with adjustment for sex and initial blood pressure, showed the effect of the dietary intervention to be -1.7 mmHg for systolic (95% CI = -0.6, -2.9, p = 0.003) and -1.5 mmHg for diastolic pressure (95% CI = -0.6, -2.5, p = 0.002). Such modest and easily attainable changes in sodium intake, if maintained, could have a significant effect on the future risk of essential hypertension among young people

Clinical outcomes, Kadish-INSICA staging and therapeutic targeting of somatostatin receptor 2 in olfactory neuroblastoma

Introduction: olfactory neuroblastoma (ONB) is a rare cancer of the sinonasal region. We provide a comprehensive analysis of this malignancy with molecular and clinical trial data on a subset of our cohort to report on the potential efficacy of somatostatin receptor 2 (SSTR2)-targeting imaging and therapy.Methods: we conducted a retrospective analysis of 404 primary, locally recurrent, and metastatic olfactory neuroblastoma (ONB) patients from 12 institutions in the United States of America, United Kingdom and Europe. Clinicopathological characteristics and treatment approach were evaluated. SSTR2 expression, SSTR2-targeted imaging and the efficacy of peptide receptor radionuclide therapy [PRRT](177Lu-DOTATATE) were reported in a subset of our cohort (LUTHREE trial; NCT03454763).Results: dural infiltration at presentation was a significant predictor of overall survival (OS) and disease-free survival (DFS) in primary cases (n = 278). Kadish-Morita staging and Dulguerov T-stage both had limitations regarding their prognostic value. Multivariable survival analysis demonstrated improved outcomes with lower stage and receipt of adjuvant radiotherapy. Prophylactic neck irradiation significantly reduces the rate of nodal recurrence. 82.4% of the cohort were positive for SSTR2; treatment of three metastatic cases with SSTR2-targeted peptide-radionuclide receptor therapy (PRRT) in the LUTHREE trial was well-tolerated and resulted in stable disease (SD).Conclusions: this study presents pertinent clinical data from the largest dataset, to date, on ONB. We identify key prognostic markers and integrate these into an updated staging system, highlight the importance of adjuvant radiotherapy across all disease stages, the utility of prophylactic neck irradiation and the potential efficacy of targeting SSTR2 to manage disease.</p