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AnteayerBMJ Open

Flap sparing in postoperative radiotherapy versus standard flap-agnostic radiotherapy of oral cavity cancers (OPTIFLAP): protocol for a de-escalation, randomised, non-inferiority, phase III trial

Por: Thariat · J. · Leconte · A. · Lequesne · J. · Vela · A. · Carsuzaa · F. · Dejean · C. · Renard · S. · Pereira · S. · Lebars · S. · Nadin · L. · Plisson · L. · Bastit · V. · Woisard · V. · Hervieu-Klisnick · Z. · Lasne-Cardon · A. · Clarisse · B.
Introduction

The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.

Methods and analysis

The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.

Ethics and dissemination

The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.

Trial registration number

NCT06798922.

Are client and provider preferences for HIV care coordination programme features concordant? Discrete choice experiments in Ryan White part A-funded New York City care coordination programmes

Por: Zimba · R. · Fong · C. · Conte · M. · Guarino · H. · Avoundjian · T. · Carmona · J. · Herndon · G. · Gambone · G. · Irvine · M. K. · Nash · D.
Objectives

The New York City (NYC) HIV Care Coordination Programme (CCP) is designed to help people with HIV (PWH) overcome barriers to care and treatment engagement. We assessed preferences for CCP components among programme enrollees (’clients’) and providers. Our objective is to compare client and provider preferences, which were previously analysed separately.

Design

We used a discrete choice experiment to assess preferences for four CCP features (‘attributes’): Help with Adherence to Antiretroviral Therapy (ART), Help with Primary Care Appointments, Help with Issues other than Primary Care and Where Programme Visits Happen. Each of these attributes had 3–4 variants (‘levels’). In the original surveys, levels within Where Programme Visits Happen varied by participant type (client vs provider). We recoded the levels by visit location (VL) or by travel time (TT) to make them comparable and report results from both approaches.

Setting

25 Ryan White Part A-funded NYC CCPs participated.

Participants

152 providers and 181 clients completed the survey.

Primary and secondary outcome measures

Preferences were quantified using the relative importance of the attributes and utility of the levels.

Results

From January 2020 to March 2021, 152 providers and 181 clients completed the survey. Most of the providers (52%) were

Conclusions

Client and provider preferences clearly diverged regarding CCP service intensity: in the aggregate, clients tended to prefer lower-intensity services, whereas providers endorsed higher-intensity services. These results highlight the importance of engaging clients as partners in decisions about programme services to facilitate alignment with client values.

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