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(PPIR) of Rapid Fetal Fibronectin Testing for Preterm Labour in Alberta

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(PPIR) of Rapid Fetal Fibronectin Testing for Preterm Labour in Alberta IHE Report Post policy implementation review (PPIR) of rapid fetal fibronectin testing for preterm labour in Alberta March 2015 (updated July 7, 2015) INSTITUTE OF HEALTH ECONOMICS The Institute of Health Economics (IHE) is an independent, not-for-profit organization that performs research in health economics and synthesizes evidence in health technology assessment to assist health policy making and best medical practices. IHE BOARD OF DIRECTORS Chair Dr. Lorne Tyrrell – Professor & CIHR/GSK Chair in Virology, University of Alberta Government and Public Authorities Ms. Janet Davidson – Deputy Minister, Alberta Health Ms. Marcia Nelson – Deputy Minister, Alberta Innovation & Advanced Education Dr. Pamela Valentine – CEO, Alberta Innovates – Health Solutions Ms. Vickie Kaminski – President & CEO, Alberta Health Services Academia Dr. Walter Dixon – Associate VP Research, University of Alberta Dr. Jon Meddings – Dean of Medicine, University of Calgary Dr. Richard Fedorak – Dean of Medicine & Dentistry, University of Alberta Dr. Ed McAuley – VP Research, University of Calgary Dr. James Kehrer – Dean of Pharmacy & Pharmaceutical Sciences, University of Alberta Dr. Braden Manns – Svare Chair in Health Economics and Associate Professor, Departments of Medicine and Community Health Sciences, University of Calgary Dr. Doug West – Chair, Department of Economics, University of Alberta Industry Ms. Lisa Marsden –VP, Cornerstone & Market Access, AstraZeneca Ms. Lauren Fischer – VP, Corporate Affairs, Eli Lilly Canada Inc. Ms. Jennifer Chan – VP, Policy & Communications, Merck Canada IHE Mr. Doug Gilpin – Chair, Audit & Finance Committee Dr. Egon Jonsson – Executive Director & CEO, Institute of Health Economics Ms. Allison Hagen – Director of Finance, Operations & Administration, Institute of Health Economics IHE Report Post policy implementation review (PPIR) of rapid fetal fibronectin testing for preterm labour in Alberta IHE Report: Post Policy Implementation Review Report that examines the health system impact of technology adoption decision conducted by the Alberta Health Technologies Decision Process. The reports are written under contract with the Alberta Health Technologies Decision Process. Acknowledgements Post policy implementation review working group: Dr. Rhada Chari Ms. Selikke Janes-Kelley (Co-Chair) Ms. Bridget Smith Dr. James Wesenberg Dr. Doug Wilson Ms. Denise Brind Dr. Thomas Corbett Dr. Carolyn DeCoster Ms. Margo Galvon Ms. Heather Crosland CRM and Data Access, Alberta Health The Alberta Perinatal Health Program Lois Hole Hospital for Women – Royal Alexandra Hospital Calgary Laboratory Services Laboratory Services, Alberta Health Services Institute of Health Economics – Dr. Ann Scott, Ms. Christa Harstall, Ms. Dagmara Chojecki, Ms. Carla Martin and Ms. Stefanie Kletke Corresponding Author Please direct any inquiries about this report to: Dr. Anderson Chuck (Co-Chair, Working Group) Director of Economic Evaluation and Analytics, Institute of Health Economics [email protected] 780-448-4881 Funding This report was supported by a financial contribution from Alberta Health (AH) through the Alberta Health Technologies Decision Process, the Alberta model for health technology assessment and policy analysis. The views expressed herein do not necessarily represent the official policy of Alberta Health. Declared Competing Interest of Authors Competing interest is considered to be financial interest of non-financial interest, either direct or indirect, that would affect the research contained in this report or create a situation in which a person’s judgement could be unduly influenced by a secondary interest such as personal advancement. The authors of this publication claim no competing interest. Suggested Citation (ICMJE or Vancouver Style) Institute of Health Economics. Post policy implementation review (PPIR) of rapid fetal fibronectin testing for preterm labour in Alberta. Edmonton AB: Institute of Health Economics. 2015. Web Address This publication is available for free download from the IHE website at http://www.ihe.ca. Reproduction, redistribution, or modification of the information for any purposes is prohibited without the express written permission of the Institute of Health Economics Institute of Health Economics, 2015 www.ihe.ca Post policy implementation review of rapid fFN testing for preterm labour in Alberta i Executive Summary Background The ability of health care providers to accurately assign risk of imminent PTD among symptomatic women with intact membranes is still limited, as early detection of PTL remains a diagnostic challenge. Therefore, the timely diagnosis of PTL and accurate prediction of risk for imminent PTD in symptomatic women presenting for care at rural or urban clinical settings is an ongoing and important goal for health care providers, in order to enable targeting of effective treatments and avoidance of unnecessary interventions. The absence of fetal fibronectin (fFN) and of phosphorylated insulin-like growth factor binding protein-1 (phIGFBP-1) in cervicovaginal secretions have shown potential to become clinically useful tests to aid in diagnosing PTL for symptomatic women with intact membranes. These tests are readily available in the form of commercial rapid response testing (point-of-care/bedside) kits (devices/systems). Technology Three testing options for ruling out PTL are available in North America. A qualitative rapid assay ® ® (the Rapid fFN for the TLiIQ System), which gives a positive or negative result. A quantitative rapid assay (the Rapid fFN® 10Q System), which gives information about the fFN concentration level in the cervicovaginal secretion of the tested woman and a rapid response method for phIGFBP-1 detection (the Actim™ Partus test) which is a qualitative assay (www.medixbiochemica.com). Policy Decision A review of the evidence on the testing options to rule out PTL was conducted under the auspices of the Alberta Health Technologies Decision Process in 2006 (others were conducted in 2008). The evidence suggested that fFN had the potential to reduce health care utilization and unnecessary treatment by more accurately identifying women who were experiencing false PTL. On September 19, 2006, the Alberta Ministry of Health issued the following policy decision to the Chief Executive Officers of the Regional Health Authorities (RHAs) in Alberta: • fFN should be introduced as a publicly funded service available to all Alberta women and through all RHAs at the earliest possible date, but no later than April 1, 2008. • Given the potential for better and more appropriate care, potential savings, and the modest costs involved, RHAs are asked to fund the introduction and on-going operating costs of fFN testing from within existing budget allocations. The target date is intended to allow sufficient time for health regions to address implementation and budget issues. • Alberta Health and Wellness supports RHAs taking a provincial approach to developing appropriate quality assurance mechanisms alongside vigilant practice guidelines and standards for the introduction of this service. Regions may also wish to explore other opportunities for collaboration, for example, bulk purchasing arrangements. The Ministry of Health issued a subsequent letter to the RHAs in March 2008, indicating that health regions could choose the service delivery option that would best serve the needs of its residents. Post policy implementation review of rapid fFN testing for preterm labour in Alberta ii The rationale for issuing the policy was as follows: • The evidence (at the time) suggested that fFN had the potential to reduce health care utilization and unnecessary treatment (ambulance transfers and/or length of hospital stay) by more accurately identifying women who were experiencing false PTL. • Adopting fFN testing province wide would ensure women had equitable access to fFN testing. • fFN testing would result in cost savings to the provincial health system through the avoidance of ambulance transfers and decreased length of stay. Objective ® All RHAs adopted fFN testing (TLiIQ System) into the health system between 2006 and 2008. We report on the results of a post-policy implementation review (PPIR) to determine whether the policy achieved its objectives. Methods The PPIR consisted of the following components: ® • A literature review update was conducted to compare the effectiveness of the TLiIQ System (fFN), 10Q (fFN) system and he Actim™ Partus test. This was conducted to determine whether there was new evidence since the health technology assessment published in 2008 that more clearly identified differences in performance between the two systems. • Key informant interviews were conducted with health system implementers from the former Alberta health regions to determine how implementation was conducted in terms of inputs and outputs, and to identify barriers, facilitators, and unintended consequences. • Economic analysis of the impact on ambulance transfers, hospital admissions, hospital length of stay and health system costs. Key Findings/Insights Literature Review Update Three diagnostic accuracy studies recently conducted in Canada compared the performance of the ® Actim™ Partus test to that of the TLiIQ System for predicting PTD in symptomatic women. The following results were reported by these studies: • Specificity and negative predictive value estimates were high for both tests at most clinical endpoints of interest and did not differ greatly between the two tests, meaning they performed
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