Status epilepticus (SE) in adults is a serious neurological emergency that can lead to high morbidity and mortality rates. Although functional outcomes are often assessed using general scoring systems, limited data on health-related quality of life (HRQoL) in patients admitted to intensive care units (ICUs) are still limited. Furthermore, comprehensive evaluations of patient-reported physical, cognitive, mental health and psychological outcomes are lacking in this population. POSEIDON 2 aims to assess HRQoL and cognitive, physical and psychological impairments at 3 and 12 months after ICU discharge following SE and quantify caregiver burden.
POSEIDON 2 is a prospective, multicentre, longitudinal study conducted in 19 French ICUs. The study combines data from the SE ICTAL Registry with data from patients who survived admission to the ICU for SE, who will be recruited for the study. The study also includes patient-reported outcome (PRO) data collected 3 (M3) and 12 (M12) months after discharge from the ICU using validated instruments. The Zarit scale will be used to measure the burden on caregivers at M3 and M12. The primary endpoint is the prevalence of overall HRQOL impairment at M3 and M12, as defined by dichotomous scores on the physical and mental components of the 36-Item Short Form Health Survey compared with those of the general population. Secondary endpoints include domain-specific impairments, such as cognitive function, dependence, mental health and patient experiences. The sample size has been calculated based on an estimated prevalence of 75% for HRQoL impairment, with a planned sample size of 140 patients.
The POSEIDON 2 study protocol received ethical approval from the ethics committee ‘Comité de Protection des Personnes Ouest VI’ on 5 October 2023 (#2023-A01223-42). The study is conducted in accordance with the Declaration of Helsinki, Good Clinical Practice and the regulatory requirements of France. Written informed consent is obtained from participants, who are able to decline participation or withdraw from the study at any time. Findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences.
The Shoulder Instability Registry (SIR) was established in 2019 to systematically capture and monitor outcomes following surgical treatment of shoulder instability (SI). The aim of this cohort profile is to describe the purpose, design, data structure and baseline characteristics of the SIR, and to outline how the registry supports longitudinal assessment of safety, functional recovery, quality of life and patient-reported outcomes after surgical treatment of SI.
The registry includes all patients treated surgically for SI. Data collection includes medical history of instability, surgical techniques and intraoperative findings. Clinical assessments include range of motion, instability-specific tests, hyperlaxity signs, Constant Score, subjective shoulder value and SI-specific scores such as the ROWE Score and the Western Ontario Shoulder Instability Index. Radiological evaluations included initial and follow-up imaging via X-rays and CT to assess bony lesions and SI-related arthropathy, as well as MRI for soft tissue injuries. Data are documented preoperatively, at 6 months and at 24 months postoperatively. Although the SIR is an observational cohort rather than a randomised clinical trial, treatment effectiveness is evaluated through longitudinal changes in validated patient-reported outcomes, clinical performance measures and imaging findings.
Between January 2019 and December 2024, 668 patients have been registered (mean age 31 years, 82% men, mean body mass index of 25). According to the American Association of Anesthesiology (ASA) Classification, 66% of patients were classified as ASA I, 33% as ASA II and only 1% as ASA III. 69% of admissions were due to accidents and 31% due to illness. Mean surgery duration was 75 min, and the median hospital stay was 2 days. 38% of patients were insured privately and had general insurance in 62%. 85% of cases were treated arthroscopically, and 15% were treated openly. Baseline clinical scores showed a mean Constant Score of 77 points, mean subjective shoulder value of 49%, mean ROWE Score of 46 points and mean Western Ontario Shoulder Instability Index of 53. Based on Gerber’s classification, 68% of cases were type B2, 29% B3, 2% B5 and fewer than 2% were classified as B4 or B1. 85% of cases suffered from anterior instability, while only 13% experienced posterior instability, the remaining 2% showed multidirectional instability. Among posterior cases, Moroder’s classification identified 58% as type B2, 19% as A2, 7% as A1, 6% as B1, 6% as C1 and 4% as C2. Regarding osteochondral lesions, 20% showed none, 31% showed a glenoid defect, 54% showed a Hill-Sachs lesion and 13% showed a cartilage defect. Scheibel’s classification identified glenoid defects as type 3a in 38% of cases, type 2 in 24%, type 1a in 13% of cases, type 3b in 11%, type 1b in 8% and type 1c in 5% of cases. Positive Gagey and Walch signs were observed in 29% and 27% of cases, respectively. Dislocations presented as primary events in 24% of cases, while 76% were recurrent. Surgical interventions included 459 (70%) Bankart repairs, 6 Bankart plus repairs (
We will continue prospectively enrolling and monitoring patients that receive surgical treatment of SI. There are no current plans to halt the data collection in the near future, thereby consistently increasing the number of patients in the registry. A larger availability of data will additionally allow us to apply machine learning modelling and develop risk-prediction tools with the goal of aiding surgical decision making.