[To evaluate the quality of life and peristomal skin ostomy patient with the new device Sensura].
Bibliographic record
Abstract
UNLABELLED: In 2006, Coloplast launched in several European countries a new device for ostomy care called Sensura. This clinical research report includes only the results of the subpopulation included in Spain as a part of an international study involving many countries such as Denmark, United States, Canada, Australia, Poland, Netherlands, France, Slovakia, Germany, UK, Italy, Iceland, Japan, Czech Republic, Portugal, South Korea and Argentina. OBJECTIVES AND STUDY VARIABLES: The main purpose of the study is to evaluate the experience with Sensura, under normal conditions of use, with special attention to skin condition and quality of life. The main objective of the study is to evaluate the quality of life, through Quality of Life Questionnaire called "Stoma QoL". A secondary objective, is to study the correlation between quality of life and the peristomal skin condition. Other Secondary objectives include the evaluation of the patient's current device at the time of entering the study and by the other hand, the device Sensura and safety evaluation throughout the study. DESIGN STUDY: The study was designed as an open label non-comparative, multi-national Post Market study. The study period for each patient is 6 to 8 weeks +/- 4 days, which includes an initial visit and a final visit. The study population included people who carry a colostomy or ileostomy. METHODOLOGY: Regarding Spain, a total of 10 sites participated and included a total of 131 patients. This report only presents results for nine sites and a total of 123 patients. The reason is that the last participating site began the study with a considerable delay The remaining subjects included in this site together with the other centers in Spain and the other participating countries will be included in the final international report, that will present the overall results. MEASUREMENT TOOLS. Stoma-QoL (Quality of Life Questionnaire for people with an ostomy). OST (Ostomy Skin Tool) instrument for the assessment of peristomal skin. RESULTS: As for the quality of life, at baseline we found a mean of 59 out of 100 (SD = 8.8), while the final study visit, mean score was 59.6 out of 100 (SD = 9.3), although the final results on this variable will be presented in the global report, since it has not reached sufficient population in Spain for the analysis of this variable. The study revealed a significant improvement in the peristomal skin condition at the end of the study, measured by the tool OST (Ostomy Skin Tool). Regarding the evaluation of the SenSura device, there was a significant improvement related to the appearance of leakage of effluent, as well as other items evaluated in relation with the device.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".