Evaluation of a training program using the SBAR communication tool for caregivers managing acute respiratory distress in lung cancer patients: A pilot randomized controlled trial protocol.

Background: Family-based caregivers are increasingly important in the management of non-hospitalized lung cancer patients. However, lack of training can negatively impact care including diagnostic errors that can lead to delays in providing appropriate medical treatment. Acute respiratory failure (ARF) is common symptom of lung cancer and requires urgent intervention as well as adequate communication with healthcare professionals (HCPs) to enable appropriate decision-making and improve patient outcomes. Standardized tools such as the Situation, Background, Assessment, Recommendation (SBAR) tool and its French adaptation SAED, standing for Situation, Antécédent, Évaluation et Demande, are designed to facilitate communication among (HCPs).Additionally, digital interventions, such as serious games, are increasingly used to train HCPs though its use for caregivers has not been studied. This pilot study aims to assess an innovative serious game training using the SAED tool combined with standard instructions on self-efficacy for family-based caregivers of lung cancer patients when facing a simulated situation of ARF. The study also aims to examine caregivers' emotional state, quality of life, satisfaction and knowledge about the SBAR tool. Methods: A monocentric, randomized, controlled, open-label, superiority, parallel-arm trial will be conducted for 18 months with 3 mid-study assessments (NCT05839353). Family caregivers of lung cancer patients will be recruited at the University Hospital Center of Saint Pierre, Reunion Island, France. Participants will be randomized (1:1) into two groups: the experimental group receiving training using the SBAR/SAED tool and standard instructions for managing respiratory distress/dyspnea, and the control group, receiving standard instructions only. The primary outcome will be to determine perceived self-efficacy as measured by the Generalized Self-Efficacy Scale. Discussion: This study will present a preliminary assessment of training family caregivers in using the SBAR/SAED tool in simulated episodes of ARF in lung cancer patients. Our findings may provide valuable insights into effective training methods for caregivers in critical home care situations and could be widely used for lung cancer management.

Psychometric properties of a Creole version of Medical Outcome Study - Short Form 36 among type II diabetes patients on Reunion Island.

Introduction: Health quality of life assessment is particularly important to measure the impact of chronic diseases. The aims of this study were to provide a cross-culturally adapted Creole-translation of the Medical Outcome Study Short-Form 36 (SF-36) and to assess psychometric performance of the Creole and French versions of the SF-36 among patients with type II diabetes in Reunion Island. Materials and methods: The Creole translation and cross-cultural adaptation processes were based on the International Quality Of Life Assessment (IQOLA) methods. Internal consistency, test-retest reliability, convergent and discriminant validity using Multi-Trait-Multi-Method analysis and structural validity using exploratory factor analysis of the SF-36 for both versions were performed. Results: In the Creole version of the SF-36, Cronbach's alpha exceeded 0.70 for all subscales except general health. In the French SF-36, Cronbach's alpha exceeded 0.70 on all subscales except general health and bodily pain. In the Creole SF-36, intraclass correlation coefficient (ICC) for reproducibility was suboptimal. Multi-trait multi-method analysis showed that item-scale correlation exceeded 0.4 for all items except two general health items of the Creole SF-36 and one of the French SF-36. Factor analysis of 2 versions showed that the physical functioning, vitality, and mental health were each divided into two subscales. Discussion: Overall, our findings provided evidence that the SF-36 is adapted to Reunion Island in both Creole and French versions. However, further research could be conducted to investigate French-Creole differences in perceived health status and a cultural adaptation of the French version will be considered.

Published registered reports are rare, limited to one journal group, and inadequate for randomized controlled trials in the clinical field.

OBJECTIVE: Registered reports (RR) are a publication format implying a peer-review of the protocol before the start of the study, followed by an in-principle acceptance (IPA) by the journal before the study starts. We aimed to describe randomized controlled trials (RCTs) in the clinical field published as RR. STUDY DESIGN AND SETTING: This cross-sectional study included RR results for RCTs, identified on PubMed/Medline and on a list compiled by the Center for Open Science. It explored the proportion of reports that received IPA (and/or published a protocol before inclusion of the first patient) and changes in the primary outcome. RESULTS: A total of 93 RCTs publications identified as RR were included. All but one were published in the same journal group. The date of the IPA was never documented. For most of these reports (79/93, 84.9%), a protocol was published after the date of inclusion of the first patient. A change in the primary outcome was noted in 40/93 (44%) of them. Thirteen of the 40 (33%) mentioned this change. CONCLUSIONS: RCTs in the clinical field identified as RR were rare, originated from a single journal group, and did not comply with the basic features of this format.