A randomised clinical study on the postoperative use of two commercially available ostomy seals (STEPS study)

2021 ◽  
Vol 19 (Sup4a) ◽  
pp. S21-S32
Author(s):  
Liz Harris ◽  
George Skountrianos ◽  
Colleen Drolshagen

Background: Ostomy seals are an accessory product used to enhance the fit of an ostomy skin barrier. Research into the clinical and health economic impact of ostomy seals is limited. Aims: To evaluate the clinical and economic impact of two commercially available ostomy seals when used on patients with a newly created stoma, 1–2 days postoperatively. Methods: A non-powered, exploratory, multi-centre, two-country, open-label, parallel-randomised clinical study was conducted. Patients were randomised to the Dansac TRE Seal (Dansac A/S, Fredensborg, Denmark) or the Coloplast Brava Protective Seal (Coloplast A/S, Humlebæk, Denmark) and were followed up to 9 weeks after the stoma was created. Clinical outcomes were primarily assessed via the validated Pittman Ostomy Complication Severity Index (OCSI). Economic outcomes were assessed via the collection of stoma-related healthcare resource use. Satisfaction measures with seal performance were also collected. Findings: In total, 42 participants were enrolled (20 TRE and 22 Brava). Lower peristomal skin complication (PSC) incidence (TRE 50.0% vs Brava 72.7%; p=.16), greater PSC resolution (TRE 70.0% vs Brava 43.8%; p=.22) and slightly less severe peristomal and stomal complications (average OCSI score TRE 2.2 vs Brava 3.4; p=.19) were observed in the TRE group. On average, participants in the TRE group used 1.3 seals per day compared with 1.4 seals per day for those in the Brava group (p=.83). Lastly, 100% of clinicians and 100% of patients reported positive satisfaction with the overall performance of TRE and Brava seals. Conclusions: Participants randomised to TRE seal were observed to have lower PSC incidence, greater PSC resolution and slightly less severe peristomal and stomal complications relative to participants using the Brava seal. No substantive differences were found in stoma-related healthcare resource use. Positive satisfaction was noted for both ostomy seals. Study results provided valuable insights into the postoperative use of ostomy seals for individuals with newly created ostomies.

2020 ◽  
pp. neurintsurg-2020-016930
Author(s):  
Osama O Zaidat ◽  
Marc Ribo ◽  
Heinrich Paul Mattle ◽  
Jeffrey L Saver ◽  
Hormozd Bozorgchami ◽  
...  

BackgroundFirst-pass effect (FPE), restoring complete or near complete reperfusion (modified Thrombolysis in Cerebral Infarction (mTICI) 2c-3) in a single pass, is an independent predictor for good functional outcomes in the endovascular treatment of acute ischemic stroke. The economic implications of achieving FPE have not been assessed.ObjectiveTo assess the economic impact of achieving complete or near complete reperfusion after the first pass.MethodsPost hoc analyses were conducted using ARISE II study data. The target population consisted of patients in whom mTICI 2c–3 was achieved, stratified into two groups: (1) mTICI 2c–3 achieved after the first pass (FPE group) or (2) after multiple passes (non-FPE group). Baseline characteristics, clinical outcomes, and healthcare resource use were compared between groups. Costs from peer-reviewed literature were applied to assess cost consequences from the perspectives of the United States (USA), France, Germany, Italy, Spain, Sweden, and United Kingdom (UK).ResultsAmong patients who achieved mTICI 2c–3 (n=172), FPE was achieved in 53% (n=91). A higher proportion of patients in the FPE group reached good functional outcomes (90-day modified Rankin Scale score 0–2 80.46% vs 61.04%, p<0.01). The patients in the FPE group had a shorter mean length of stay (6.10 vs 9.48 days, p<0.01) and required only a single stent retriever, whereas 35% of patients in the non-FPE group required at least one additional device. Driven by improvement in clinical outcomes, the FPE group had lower procedural/hospitalization-related (24–33% reduction) and annual care (11–27% reduction) costs across all countries.ConclusionsFPE resulted in improved clinical outcomes, translating into lower healthcare resource use and lower estimated costs.


Author(s):  
Valentina Perrone ◽  
Diego Sangiorgi ◽  
Stefano Buda ◽  
Margherita Andretta ◽  
Silvio Borrè ◽  
...  

AIM: The aim of the study was to evaluate healthcare resource use and related costs for the management of people living with Human Immunodeficiency Virus (PLWHIV) with and without comorbidities, and to compare the burden of comorbidities in PLWHIV to the general population.METHODS: An observational retrospective analysis, based on administrative and laboratory databases from 6 Italian Local Health Units (LHUs) was performed. Individuals receiving either an HIV treatment [Antiretroviral therapy (ART) – ATC code: J05A)], or with an HIV positive laboratory test result between January 1st, 2014 and December 31st, 2014 were included. The date of first ART prescription or positive test of HIV was used as the Index Date (ID). Patients enrolled were followed-up for all time available from the ID (follow-up period) and their clinical characteristics were investigated from one year prior to the ID (characterization period). Comorbidities were measured by using the Charlson Comorbidity Index; findings were compared with those of a sample of the general population with the same age and sex distribution (OsMed 2015). Healthcare resource use and related cost was evaluated during the follow-up period.RESULTS: 1,214 patients were included, 837 were PLWHIV without any comorbidities and 377 were PLWHIV with at least one comorbidity. Mean prevalence of prescriptions for treatment of comorbidities was higher in the HIV-infected population than in the Italian general population. The annual healthcare cost of managing HIV patients with comorbidities, was significantly higher than that for patients without comorbidities (€ 10,615 vs. € 8,665, p < 0.001).CONCLUSIONS: Study results showed that 30% of PLWHIV had at least one comorbidity. The cost of managing PLWHIV who have comorbidities was significantly higher than that of managing PLWHIV without comorbidities. Our data confirm that care and treatment services should be adapted to address the specific needs of people living with both HIV and comorbidities.


BMJ Open ◽  
2021 ◽  
Vol 11 (4) ◽  
pp. e049623
Author(s):  
Leona K Shum ◽  
Herbert Chan ◽  
Shannon Erdelyi ◽  
Lulu X Pei ◽  
Jeffrey R Brubacher

IntroductionRoad trauma (RT) is a major public health problem affecting physical and mental health, and may result in prolonged absenteeism from work or study. It is important for healthcare providers to know which RT survivors are at risk of a poor outcome, and policy-makers should know the associated costs. Unfortunately, outcome after RT is poorly understood, especially for RT survivors who are treated and released from an emergency department (ED) without the need for hospital admission. Currently, there is almost no research on risk factors for a poor outcome among RT survivors. This study will use current Canadian data to address these knowledge gaps.Methods and analysisWe will follow an inception cohort of 1500 RT survivors (16 years and older) who visited a participating ED within 24 hours of the accident. Baseline interviews determine pre-existing health and functional status, and other potential risk factors for a poor outcome. Follow-up interviews at 2, 4, 6, and 12 months (key stages of recovery) use standardised health-related quality of life tools to determine physical and mental health outcome, functional recovery, and healthcare resource use and lost productivity costs.Ethics and disseminationThe Road Trauma Outcome Study is approved by our institutional Research Ethics Board. This study aims to provide healthcare providers with knowledge on how quickly RT survivors recover from their injuries and who may be more likely to have a poor outcome. We anticipate that this information will be used to improve management of all road users following RT. Healthcare resource use and lost productivity costs will be collected to provide a better cost estimate of the effects of RT. This information can be used by policy-makers to make informed decisions on RT prevention programmes.


2015 ◽  
Vol 18 (7) ◽  
pp. A466
Author(s):  
F Lopes ◽  
MJ Passos ◽  
A Raimundo ◽  
PA Laires

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