Développement et évaluation des propriétés psychométriques d’un questionnaire mesurant les impacts organisationnels de dispositifs médicaux selon le personnel soignant : le QPIO-DM-UP

Mathy, caryn and Favez, Lauriane (2024): Développement et évaluation des propriétés psychométriques d’un questionnaire mesurant les impacts organisationnels de dispositifs médicaux selon le personnel soignant : le QPIO-DM-UP.

Abstract

Context

Health technology assessment is mainly based on clinical and economic criteria. Since 2020, the French assessment agency has also sometimes been taking into consideration organizational impacts of health technologies, such as medical devises, that are used routinely by nursing staff. These impacts are however difficult to measure on a routine basis, as many are intangible and no tool exists to measure them.

Objective

To develop and test a questionnaire measuring nursing staff perception of the organizational impacts of medical devices in use. Method: Mixed methods were used to develop and validate the questionnaire. Literature reviews, semi-structured interviews, focus groups and a cross-sectional pilot study were used to develop a questionnaire, The questionnaire’s psychometric properties were tested (Cronbach’s alpha, factorial analysis).

Results

A questionnaire of perception of organisational impacts of medical devices for professional users (i.e., staff) (the QPOI-MD-PU) of 13 dimensions, including 12 sub-dimensions, and 50 items was developed and tested with 204 nursing staff members using a glucometer. Psychometric analyses demonstrated the preliminary validity of the questionnaire.

Conclusion

This study proposes a questionnaire to assess nurses’ perceptions of organizational impacts of medical devices, filling a gap in the field. The qualitative and quantitative methods used enabled the development and preliminary validation of this questionnaire in French. Its use can only be recommended following larger-scale confirmatory studies, using different types of medical devices.

• Item Type: MPRA Paper
• English Title: Development and evaluation of the psychometric properties of a questionnaire measuring nursing staff's perception of the organizational impact of medical devices: the QPOI-MD-PU
• Language: French
• Keywords: Medical devices; Nurses; Dimension; Questionnaire; Health technology Assessment; Organisational Impacts
• Subjects: B - History of Economic Thought, Methodology, and Heterodox Approaches > B4 - Economic Methodology > B41 - Economic Methodology; C - Mathematical and Quantitative Methods > C8 - Data Collection and Data Estimation Methodology ; Computer Programs > C83 - Survey Methods ; Sampling Methods; I - Health, Education, and Welfare > I1 - Health > I19 - Other; O - Economic Development, Innovation, Technological Change, and Growth > O3 - Innovation ; Research and Development ; Technological Change ; Intellectual Property Rights > O33 - Technological Change: Choices and Consequences ; Diffusion Processes

References

[1] Oortwijn W, Sampietro-Colom L, Habens F. Developments in value frameworks to inform the allocation of healthcare resources. Int J Technol Assess Health Care 2017;33(2):323‑9.

[2] Tanios N, Wagner M, Tony M, Baltussen R, van Til J, Rindress D, et al. Which criteria are considered in healthcare decisions? Insights from an international survey of policy and clinical decision makers. Int J Technol Assess Health Care 2013;29(4):456‑65.

[3] Organisation de Coopération et de Développement Economique (OECD). Technologies de la santé et prise de décision [Internet]. Paris: Organisation for Economic Co-operation and Development; 2005. Available from: https://www.oecd-ilibrary.org/science-and-technology/technologies-de-la-sante-et-prise-de-decision_9789264108394-fr

[4] Velasco M, Perleth M, Drummond M, Gürtner F, Jørgensen T, Jovell A, et al. Best practice in undertaking and reporting health technology assessments. Working group 4 report. Int J Technol Assess Health Care 2002;18(2):361‑422.

[5] Wouters OJ, Naci H, Samani NJ. QALYs in cost-effectiveness analysis: an overview for cardiologists. Heart Br Card Soc 2015;101(23):1868‑73.

[6] Brouwer W, van Exel J, Baker R, Donaldson C. The new myth: the social value of the QALY. PharmacoEconomics 2008;26(1):1‑4.

[7] Goldman D, Lakdawalla D, Philipson TJ, Yin W. Valuing health technologies at NICE: recommendations for improved incorporation of treatment value in HTA. Health Econ 2010;19(10):1109‑16.

[8] Porter ME. What is value in health care? N Engl J Med. 23 déc 2010;363(26):2477‑81.

[9] World Health Organization. Antigen-detection in the diagnosis of SARS-CoV-2 infection [Internet]. 2021 oct p. 20. (COVID-19: Laboratory and diagnosis). Disponible sur: https://www.who.int/publications-detail-redirect/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays

[10] World Health Organization. Note d’orientation de l’OMS : Tests de diagnostic de la COVID-19, 14 septembre 2022 [Internet]. 2022 09 p. 7. (Document de politique). Disponible sur: https://www.who.int/fr/publications-detail/WHO-2019-nCoV-Policy_Brief-Testing-2022.1

[11] Australian Commission on Safety and Quality in Health Care. Patient-reported outcome measures. Literature review. Australian Commission on Safety and Quality in Health Care; 2016 p. 91.

[12] Desomer, A, Van den Heede, K, Triemstra, M, Paget, J, De Boer, D, Kohn, L, et al. Use of patient-reported outcome and experience measures in patient care and policy. Brussels: Belgian Health Care Knowledge Centre (KCE) 2018. Report No.: 303.

[13] European Network for Health Technology Assessment. Joint Action 2, Work Package 8, HTA Core Model [Internet]. National Institute for Helath and Welfare 2016. Report No.: Version 3.0. Disponible sur: https://www.htacoremodel.info/BrowseModel.aspx

[14] Craig JA, Carr L, Hutton J, Glanville J, Iglesias CP, Sims AJ. A review of the economic tools for assessing new medical devices. Appl Health Econ Health Policy 2015;13(1):15‑27.

[15] Tarricone R, Torbica A, Drummond M. Challenges in the Assessment of Medical Devices: The MedtecHTA Project. Health Econ 2017;26 Suppl 1:5‑12.

[16] Dubromel A, Duvinage-Vonesch MA, Geffroy L, Dussart C. Organizational aspect in healthcare decision-making: a literature review. J Mark Access Health Policy 2020;8(1):1810905.

[17] Pascal C, Mathy C, Bongiovanni I, Konishi M. Integrating organizational impacts into health technology assessment (HTA): an analysis of the content and use of existing evaluation frameworks. Int J Technol Assess Health Care 2022;38(1):e80.

[18] Haute Autorité de Santé. Guide méthodologique - Cartographie des impacts organisationnels pour l’évaluation des technologies de santé [Internet]. 2020. Disponible sur: https://www.has-sante.fr/upload/docs/application/pdf/202012/

[19] Mathy C, Pascal C, Bongiovanni-Delarozière I, Favez L. Proposing a health-specific organizational impact framework to evaluate organizational impacts in health technology assessments. Int J Technol Assess Health Care 2023;39(1):e60.

[20] Brynjolfsson E, Hitt LM, Yang S. Intangible Assets: Computers and Organizational Capital. Brook Pap Econ Act [Internet].2002(1):137‑81. Disponible sur: https://www.jstor.org/stable/1209176

[21] de Veer AJE, Fleuren MAH, Bekkema N, Francke AL. Successful implementation of new technologies in nursing care: a questionnaire survey of nurse-users. BMC Med Inform Decis Mak 2011;11:67.

[22] Hatz MHM, Schreyögg J, Torbica A, Boriani G, Blankart CRB. Adoption Decisions for Medical Devices in the Field of Cardiology: Results from a European Survey. Health Econ 2017;26 Suppl 1:124‑44.

[23] Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, et al. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 2010;19(4):539‑49.

[24] Mokkink LB, de Vet HCW, Prinsen CAC, Patrick DL, Alonso J, Bouter LM, et al. COSMIN Risk of Bias checklist for systematic reviews of Patient-Reported Outcome Measures. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 2018;27(5):1171‑9.

[25] Terwee CB, Prinsen CAC, Chiarotto A, Westerman MJ, Patrick DL, Alonso J, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res Int J Qual Life Asp Treat Care Rehabil 2018;27(5):1159‑70.

[26] Brod M, Tesler LE, Christensen TL. Qualitative research and content validity: developing best practices based on science and experience. Qual Life Res. 2009 Nov;18(9):1263-78.

[27] Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, Ring L. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health. 2011 Dec;14(8):978-88.

[28] Mokkink LB, Prinsen CAC, Patrick DL, Alonso J, Bouter LM, de Vet HCW, Terwee CB. COSMIN Study Design checklist for Patient-reported outcome measurement instruments. Version July 2019. Amsterdam Public Health research institute, Amsterdam University Medical Centers, location VUmc. Disponible sur : www.cosmin.nl.

[29] Wohlin, C., Kalinowski, M., Romero Felizardo, K., & Mendes, E. Successful combination of database search and snowballing for identification of primary studies in systematic literature studies. Information and Software Technology, (2022). 106908. https://doi.org/10.1016/j.infsof.2022.106908

[30] Rogers E. Diffusion of innovation. Free Press. New York; 1995.

[31] Goodhue DL, Thompson RL. Task-Technology Fit and Individual Performance. MIS Q [Internet]. 1995;19(2):213‑36. Disponible sur: https://www.jstor.org/stable/249689

[32] Tavakol M, Dennick R. Making sense of Cronbach’s alpha. Int J Med Educ [Internet] 2011 [cité 8 juin 2024];2:53‑5. Disponible sur: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4205511/

[33] Streiner DL. Starting at the beginning: An introduction to coefficient alpha and internal consistency. J Pers Assess 2003;80(1):99‑103.

[34] Commission européenne. Santé Publique- Commission européenne - Dispositif médicaux - Secteur - Présentation [Internet]. Disponible sur: https://health.ec.europa.eu/medical-devices-sector/overview_fr

[35] Parlement europééen. Médicaments et dispositifs médicaux | Fiches thématiques sur l’Union européenne | Parlement européen [Internet]. 2024. Disponible sur: https://www.europarl.europa.eu/factsheets/fr/sheet/50/medicaments-et-dispositifs-medicaux