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Patient Reported Outcomes clinical trials

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NCT ID: NCT06100978 Not yet recruiting - Clinical trials for Patient Satisfaction

Patient-reported Outcome and Patient-reported Experience After Status Epilepticus

POSEIDON2
Start date: March 1, 2024
Phase:
Study type: Observational

Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress. Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.

NCT ID: NCT06012318 Not yet recruiting - Esophageal Cancer Clinical Trials

Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)

Start date: September 10, 2023
Phase:
Study type: Observational

Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer. Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy and radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients' functional status during treatment. However, the spectrum of symptoms in esophageal cancer patients receiving immunotherapy is uncertain, and there are no studies applying the symptom bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective study, the investigators aimed to preliminarily screen for symptoms associated with immunotherapy for esophageal cancer through a systematic literature review and expert evaluation, and build a symptom item bank for esophageal cancer patients receiving immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were collected prospectively. The distribution and severity of the symptoms, as well as the trajectory of symptom change were further analyzed to demonstrate the validity and reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal cancer patients receiving immunotherapy and provide a foundation for assessing the specific symptom burden in patients with esophageal cancer receiving immunotherapy regimens.

NCT ID: NCT06002516 Not yet recruiting - Clinical trials for Irritable Bowel Syndrome

RELIEF-pathway in Patients With Upper Abdominal Pain

RELIEF
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Upper abdominal pain (UAP) is a common symptom and frequently the reason to visit the hospital. The prevalence of epigastric pain in the Dutch population is estimated to be as high as 37%. Moreover, Dutch hospitals yearly record >100.000 diagnoses related to UAP. In most patients, UAP can be attributed to symptomatic (functional) dyspepsia (FD), Irritable Bowel Syndrome (IBS) or uncomplicated gallstone disease (cholecystolithiasis), with a prevalence in the general population of 20-30%, 20%, and 6-9%, respectively. However, these conditions may have overlapping symptom patterns and generally affect similar populations. which contributes to ineffective (diagnostic) interventions. Patients are generally not aware of the similarity of symptoms and the poor outcome of some treatments. Education positively influences patients' self-management and health judgment. In a recent open-label, multicentre trial the effectiveness of web-based patients' education is applied to reduce overuse of upper gastrointestinal endoscopies in patients with dyspepsia. This study illustrated that an web-based education tool safely reduced 40% in upper gastrointestinal endoscopies. Lifestyle interventions (such as change of diet and/or physical activity) are widely incorporated in treatment programs for cardio-vascular diseases including diabetes mellitus and obesity. An web-based education tool on upper abdominal pain and other complaints combined with a lifestyle interventions for patients may be an effective treatment option for this large group of patients. This study investigates the potential of an individualized web-based education tool as intervention for patients with functional dyspepsia, irritable bowel syndrome and uncomplicated symptomatic cholecystolithiasis with the possibility to visit the Prevention and Lifestyle clinic (RELIEF pathway). The RELIEF pathway aims to reduce unnecessary health care utilization and, secondly, to maintain and improve quality of life by educating patients on lifestyle improvement.

NCT ID: NCT04397627 Not yet recruiting - Colorectal Surgery Clinical Trials

ERAS Program Items Adherence, PROMs and RIOT After Colorectal Surgery

iCral3
Start date: November 1, 2020
Phase:
Study type: Observational

Prospective multicenter observational no-profit study evaluating the impact of ERAS program items adherence rates on patient-reported outcomes (PRO) and return to intendend oncologic therapy (RIOT) after colorectal resection. Prospective enrollment from November 2020 to October 2021 in 60 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent. A total of 3,000 patients is expected based on a mean of 50 cases per center.

NCT ID: NCT03871920 Not yet recruiting - Clinical trials for Patient Reported Outcomes

Psychometric Evaluation of the Short Patient Evaluation Questionnaire

Start date: June 1, 2019
Phase:
Study type: Observational

It is important for physiotherapy in general and for the individual physio-therapist to demonstrate the result of the interventions in physiotherapy. The new short (4 items) generic questionnaire Short Patient Evaluation Questionnaire SPEQ was especially developed for use in private practices to answer the main questions for evaluation of treatment. This research project aims at evaluating the reliability, validity and responsiveness of the SPEQ and at providing an estimate for Minimal Important Difference MID that may be used as threshold for clinical relevant changes.