A latanoprost cationic emulsion (STN1013001) vs. other latanoprost formulations (Latanoprost) in open angle glaucoma/ocular hypertension and ocular surface disease: an Italian cost-utility analysis.

BACKGROUND: STN1013001 is an innovative latanoprost cationic emulsion for open-angle glaucoma/ocular hypertension (OAG/OHT) and ocular surface disease (OSD). METHODS AND FINDINGS: A 5-year, 7 health states, 1-year cycle early Markov model-supported cost-utility analysis (CUA) of STN1013001 vs. other latanoprost formulations (Latanoprost) followed the Italian National Health Service (INHS) perspective.One-way, probabilistic and scenario sensitivity analyses tested the uncertainty of the baseline results. Value of information analysis (VOIA) investigated the potential cost-effectiveness of collecting further evidence. RESULTS: Over 5 years, the Markov model-supported CUA predicts STN1013001 to be potentially highly cost-effective vs. Latanoprost (+€57.60 cost at €2020 values; +0.089 Quality-Adjusted Life Years).The Incremental Cost-Utility Ratio (€647.65) falls well below the lower limit of the acceptability range proposed for Italy (€25,000-€40,000).Sensitivity analyses confirmed the robustness of the baseline findings. VOIA highlighted that further information might only be cost-effective for OAG/OHT utilities and OSD-related disutility. CONCLUSION: STN1013001 is potentially highly cost-effective and strongly dominant vs. Latanoprost for OAG/OHT+OSD patients from the INHS perspective. These findings should be re-assessed using the data from the ongoing Phase III trial (NCT04133311) comparing the efficacy and safety of STN1013001 vs. Latanoprost and with future real-world CUAs upon the availability of STN1013001 on the Italian market.

A comparative cost analysis of transanal and laparoscopic total mesorectal excision for rectal cancer.

Despite proven clinical benefits in the short term, technical difficulties limit utilization of laparoscopy in rectal cancer surgery (RCS). Transanal Total Mesorectal Excision (taTME) overcomes many technical limitations of laparoscopic RCS. However, the costs of this procedure have not been addressed yet. Our goal was to perform a comparative cost analysis of taTME and laparoscopic TME (lapTME). Consecutive patients undergoing curative TME between 1 February 2014 and 31 October 2018 were selected from a prospectively maintained database and stratified, according to the type of procedure, into taTME and lapTME groups. Patient demographics, tumour characteristics, operative parameters, and short-term outcomes were analyzed. The main outcome measure was intraoperative costs of the two procedures. Secondary outcomes were short-term outcome and the utilization of hospital resources to manage the postoperative course. Hundred and fifty-two patients with rectal cancer (66 lapTME, 86 taTME) were included in the study. Surgical supplies required for taTME procedure exceeded the cost of lapTME of 754,54 €. The duration of surgery was not significantly different between the two approaches (266 ± 92.85 vs 271 ± 83.63, p = 0.50). Short-term outcomes were comparable including postoperative complication rate (17 vs 20%, p = 0.68), reintervention rate, and length of stay. There was no difference in hospital resources utilization to manage postoperative course including blood test, diagnostics, consultations, and medications. TaTME has higher intraoperative costs in terms of supplies with respect to lapTME. Short-term outcomes and hospital resources to manage postoperative course are comparable.

Assessment of the Quality of Patient-Orientated Information on Surgery for Crohn's Disease on the Internet.

BACKGROUND: The Internet is a vast resource for patients to search for health information on the treatment of Crohn's disease. OBJECTIVE: This study examines the quality of Web sites that provide information to adults regarding Crohn's disease, including treatment options and surgery. DESIGN: Two search engines (Google and Yahoo) and the search terms "surgery for Crohn's disease" were used. The first 50 sites of each search were assessed. Sites that fulfilled the inclusion criteria were evaluated for content and scored by using the DISCERN instrument, which evaluates the quality of health information on treatment choices. RESULTS: One hundred sites were examined, of which 13 were duplicates. Sixty-two sites provided patient-orientated information. The other sites included 7 scientific articles, 3 blogs, 2 links, 6 forums, 3 video links, and 4 dead links. Of the 62 Web sites that provided patient information for adults, only 15 (24.2%) had been updated within the past 2 years. Only 9 (14.5%) were affiliated with hospitals and clinics. The majority of sites (33, 53.2%) were associated with private companies with commercial interests. Only half of the Web sites provided details on treatment options, and most Web sites did not provide any information on symptoms and procedure details. Just 5 Web sites (8.1%) described the risks of surgery, and only 7 (11.3%) provided any information on the timescale for recovery. Overall, only 1 Web site (1.6%) was identified as being "good" or "excellent" with the use of the DISCERN criteria. LIMITATIONS: Although the internet is constantly evolving, this study captures data at a specific time point. Search results may vary depending on geographical location. This study only assessed English language websites. CONCLUSIONS: The quality of patient information on surgery for Crohn's disease is highly variable and generally poor. There is potential for the Internet to provide valuable information, and clinicians should identify high-quality Web sites to guide their patients.

Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial.

BACKGROUND: Currently there is no guideline for the treatment of patients with Crohn's disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs. METHODS/DESIGN: This is a multicentre, randomized controlled trial. Patients with Crohn's disease who are over 18 years of age, with newly diagnosed or recurrent active high perianal fistulas, with one internal opening and no anti-TNF usage in the past three months will be considered. Patients with proctitis, recto-vaginal fistulas or anal stenosis will be excluded. Prior to randomisation, an MRI and ileocolonoscopy are required. All treatment will start with seton placement and a course of antibiotics. Patients will then be randomised to: (1) chronic seton drainage (with oral 6-mercaptopurine (6MP)) for one year, (2) anti-TNF medication (with 6MP) for one year (seton removal after six weeks) or (3) advancement plasty after eight weeks of seton drainage (under four months anti-TNF and 6MP for one year). The primary outcome parameter is the number of patients needing fistula-related re-intervention(s). Secondary outcomes are the number of patients with closed fistulas (based on an evaluated MRI score) after 18 months, disease activity, quality of life and costs. DISCUSSION: The PISA trial is a multicentre, randomised controlled trial of patients with Crohn's disease and high perianal fistulas. With the comparison of three generally accepted treatment strategies, we will be able to comment on the efficiency of the various treatment strategies, with respect to several long-term outcome parameters. TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).