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      A Medicoeconomic Evaluation of a Telehealth Platform for Elective Outpatient Surgeries: Protocol for a Randomized Controlled Trial

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          Abstract

          Background

          The number of elective outpatient surgeries in Canada has increased markedly in the last 10 years. However, unanticipated cancellations on the day of surgery and adverse postoperative events are frequent. Modern technologies have been shown to be of great help in the medical field in improving patient care. Thus, it is likely that dedicated technologies could also significantly improve surgical outpatients’ pathways. Therefore, the department of anesthesiology at the University of Montreal Medical Center, in collaboration with LeoMed, a telemedicine platform, has developed a telehealth solution to offer more efficient perioperative support and follow-up for patients undergoing ambulatory surgery.

          Objective

          The objective is to evaluate the medicoeconomic benefit of a dedicated perioperative telehealth platform for patients undergoing day surgery. Our hypothesis is that this dedicated telecare solution will allow more efficient patient care, which will reduce all types of medical costs related to day surgery pathways.

          Methods

          This study is a single-center, single-blinded, 2-group randomized controlled trial. One thousand patients aged over 18 years with internet access who are scheduled to undergo ambulatory surgery will be enrolled and randomized either to follow a perioperative path that includes a patient-tailored perioperative digital app via the LeoMed telecare platform for 1 month or to follow the standard of care, which does not offer personalized digital support. The primary outcome will be to evaluate the cost-effectiveness of the telecare platform, assessing direct costs from factors such as unanticipated cancellations on the day of surgery due to preoperative instructions not being followed, calls to the local health information line, calls to the provincial health information line, emergency department consultations, unplanned readmissions, or medical visits for problems related to the surgical procedure within the first 30 days after the intervention. The secondary outcome will be to evaluate cost utility using a questionnaire assessing quality-adjusted life years. A blinded independent research team will analyze outcomes. All data will be analyzed according to the intention-to-treat principle. A sample size of 500 subjects in each group was calculated to detect a 21% reduction in postoperative complications with a power of 90%. This study has been approved by the ethics board of Centre hospitalier de l’Université de Montréal (University of Montreal Health Centre). No employee of LeoMed was involved in the study conception, and none will be involved in either data collection or analysis.

          Results

          Results of this trial will be useful to determine the economic benefit of a telecare platform specifically developed for surgical outpatient pathways.

          Conclusions

          We believe that the deployment of a dedicated perioperative telehealth app will lead to better patient care and fewer postoperative complications, which will lower all types of costs related to surgical outpatient care.

          Trial Registration

          ClinicalTrials.gov NCT04948632; https://ClinicalTrials.gov/ct2/show/NCT04948632

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/44006

          Related collections

          Most cited references35

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          Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)

          Purpose This article introduces the new 5-level EQ-5D (EQ-5D-5L) health status measure. Methods EQ-5D currently measures health using three levels of severity in five dimensions. A EuroQol Group task force was established to find ways of improving the instrument’s sensitivity and reducing ceiling effects by increasing the number of severity levels. The study was performed in the United Kingdom and Spain. Severity labels for 5 levels in each dimension were identified using response scaling. Focus groups were used to investigate the face and content validity of the new versions, including hypothetical health states generated from those versions. Results Selecting labels at approximately the 25th, 50th, and 75th centiles produced two alternative 5-level versions. Focus group work showed a slight preference for the wording ‘slight-moderate-severe’ problems, with anchors of ‘no problems’ and ‘unable to do’ in the EQ-5D functional dimensions. Similar wording was used in the Pain/Discomfort and Anxiety/Depression dimensions. Hypothetical health states were well understood though participants stressed the need for the internal coherence of health states. Conclusions A 5-level version of the EQ-5D has been developed by the EuroQol Group. Further testing is required to determine whether the new version improves sensitivity and reduces ceiling effects.
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            SPIRIT 2013 statement: defining standard protocol items for clinical trials.

            The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.
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              The impact of pain management on quality of life.

              Although its inclusion in medical research is relatively recent and its interpretation is often variable, quality of life is increasingly being recognized as one of the most important parameters to be measured in the evaluation of medical therapies, including those for pain management. Pain, when it is not effectively treated and relieved, has a detrimental effect on all aspects of quality of life. This negative impact has been found to span every age and every type and source of pain in which it has been studied. Effective analgesic therapy has been shown to improve quality of life by relieving pain. Opioid analgesics, cyclooxygenase (COX)-2 inhibitors (or coxibs), and several adjuvant analgesics for neuropathic pain have been demonstrated to significantly improve quality-of-life scores in patients with pain. Coxibs provide effective, well-tolerated analgesia without some of the issues faced with opioids-benefits that should translate into improved quality of life. Recent studies have demonstrated that the COX-2 inhibitor rofecoxib significantly improves quality of life in patients with osteoarthritis and chronic, lower back pain. Quality-of-life measurements, especially symptom distress scales, can also be used as sensitive means of differentiating one agent from another in the same class. In future pharmacotherapeutic research, quality of life should be included as an outcome domain as are the traditionally measured variables of efficacy and safety. In particular, future studies of coxibs should include symptom distress scores as important quality-of-life measurements, to identify meaningful differences between this new class of analgesics and nonselective nonsteroidal anti-inflammatory drugs.
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                Author and article information

                Contributors
                Journal
                JMIR Res Protoc
                JMIR Res Protoc
                ResProt
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                1929-0748
                2023
                24 April 2023
                : 12
                : e44006
                Affiliations
                [1 ] Department of Anesthesiology and Pain Medicine University of Montreal Montreal, QC Canada
                [2 ] Department of Anesthesiology Centre hospitalier de l'Université de Montréal Montreal, QC Canada
                [3 ] Research Center Centre hospitalier de l'Université de Montréal Montreal, QC Canada
                [4 ] École des Hautes Études Commerciales Montréal, QC Canada
                [5 ] School of Public Health University of Montreal Montréal, QC Canada
                Author notes
                Corresponding Author: Florian Robin florianrobin.bdx@ 123456gmail.com
                Author information
                https://orcid.org/0000-0002-5813-1164
                https://orcid.org/0000-0002-0387-2395
                https://orcid.org/0000-0002-0401-8713
                https://orcid.org/0000-0002-9988-0399
                https://orcid.org/0000-0001-7061-1032
                https://orcid.org/0000-0002-7102-9893
                https://orcid.org/0000-0001-5180-8139
                https://orcid.org/0000-0001-8202-0395
                https://orcid.org/0000-0001-7425-1994
                Article
                v12i1e44006
                10.2196/44006
                10167590
                37093634
                bd563169-36b9-4c95-ae44-c380541d4b90
                ©Florian Robin, Maxim Roy, Alexandre Kuftedjian, Laurelie Perret, Frédéric Lavoie, Alexandre Castonguay, Marie-Pascale Pomey, Cedrick Zaouter, Guy Pare. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 24.04.2023.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

                History
                : 2 November 2022
                : 5 January 2023
                : 15 February 2023
                : 20 February 2023
                Categories
                Protocol
                Protocol

                outpatient surgery,cost-effectiveness,telehealth solution,surgery,technologies,quality,safety,support,patient,cost,telecare,telehealth,platform,development

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