A Systematic Review of Reported Outcomes in Randomized Controlled Trials Targeting Early Interventions in Moderate-to-Severe Traumatic Brain Injury.

Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Randomized controlled trials (RCTs) are the cornerstone to evaluate the efficacy of an intervention. To assess the methodology of clinical research, we performed a systematic review that evaluated the different outcomes used in RCTs targeting the early phase of moderate-to-severe adult TBI from 1983 to October 31, 2023. We extracted each outcome and organized them according to the COMET and OMERACT framework (core area, broad domains, target domains, and finally outcomes). A total of 190 RCTs were included, including 52,010 participants. A total of 557 outcomes were reported and classified between the following core areas: pathophysiological manifestations [169 RCTs (88.9%)], life impact [117 RCTs (61.6%)], death [94 RCTs (49.5%)], resource use [72 RCTs (37.9%)], and adverse events [41 RCTs (21.6%)]. We identified 29 broad domains and 89 target domains. Among target domains, physical functioning [111 (58.4%)], mortality [94 (49.5%)], intracranial pressure target domain [68 (35.8%)], and hemodynamics [53 (27.9%)] were the most frequent. Outcomes were mostly clinician-reported [177 (93.2%)], while patient-reported outcomes were rarely reported [11 (5.8%)]. In our review, there was significant heterogeneity in the choice of end-points in TBI clinical research. There is an urgent need for consensus and homogeneity to improve the quality of clinical research in this area.

Evaluation of the impact of pharmacist-led educational intervention on knowledge and skills of cancer patients with totally implantable venous access port: a single-centre, non-randomised controlled study.

BACKGROUND: Totally implantable venous access port (TIVAP) is a type of implantable medical device that enables repetitive access to the intravenous system through use of a Huber needle. This device facilitates the administration of aggressive or long-term treatments while ensuring the comfort and safety of the patient. To ensure proper use of the medical device and lower the risk of complications, it is essential that patients acquire the necessary knowledge and skills regarding TIVAP. OBJECTIVE: The main objective of the study was to assess the impact of a pharmaceutical interview on patients' knowledge and skills for patients with TIVAP. METHODS: To achieve this goal, a pharmaceutical interview guide and an 18-item questionnaire were developed, based on a three-part competency framework (knowledge, know-how and attitudes) previously constructed by a multidisciplinary team. The intervention consisted of a pharmacist-led interview with every patient on the day of the TIVAP insertion. Patients in the control group received usual care. Patients included were interviewed by telephone 14 days after implantation. χ2 tests were conducted to compare the scores obtained by each group. RESULTS: The average score obtained by the control group (n=30) was 8.97, while the intervention group (n=59) achieved an average score of 12.66 (p<0.001). The intervention group demonstrated increases in correct responses for all items, with eight questions displaying significantly higher scores. Six of these pertained to theoretical knowledge, one to know-how and one to attitudes. CONCLUSION: The interviews had a clear impact on the knowledge and skills of TIVAP patients.

Complications and risk factors on midline catheters' follow-up about non-ICU patients: study protocol for a multicentre observational study (the midDATA study).

INTRODUCTION: The midline catheter (MC) is an increasingly popular device used commonly for patients with difficult venous access or those who require infusion for more than 6 days. Little is known about complications such as infection, thrombosis or occlusion for inpatient and home care patient. This protocol presents the follow-up of non-intensive care unit patients with an MC. The aim is to identify complications and search for risk factors associated with these complications. METHOD AND ANALYSIS: A prospective observational design is used for the follow-up of 2000 patients from 13 centres in France. Each practitioner (inserting clinician, anaesthetist nurse, hospital nurse and home nurse) will fill out a logbook to report each care made (eg, number of saline flushes, dress maintenance) on the MC and if any complications occurred. The incidence of complications (ie, infections, thrombosis or occlusions) will be expressed by the total number of events per 1000 catheter days. The period of recruitment began in December 2019 for a duration of 2 years. An extension of the inclusion period of 1 year was obtained. ETHICS AND DISSEMINATION: This study received the approval of the Committee for the Protection of Persons of Nord Ouest IV (No EudraCT/ID-RCB : 2019-A02406-51). It was registered at clinical trials (NCT04131088). It is planned to communicate results at conferences and in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04131088.