EXPLORATION AND PREFERENTIAL RANKING OF PATIENT BENEFITS OF MEDICAL DEVICES: A NEW AND GENERIC INSTRUMENT FOR HEALTH ECONOMIC ASSESSMENTS

• Published in: International journal of technology assessment in health care 2017-01, Vol.33 (4), p.463-471
• Main Authors: Lesén, Eva, Björholt, Ingela, Ingelgård, Anders, Olson, Fredrik J.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Clinical outcomes; Cognitive ability; Cost analysis; Diabetes; Disabilities; Disability; Disease; Environmental & Occupational; Equipment and Supplies - standards; Equipment Design; Exploration; Female; Health; Health care; Health Care Sciences & Services; Health economics; Health technology assessment; Healthcare evaluation mechanisms; Humans; Identification methods; Kirurgi; Male; Medical device; Medical device industry; Medical devices; Medical equipment; Medical Informatics; Medical technology; Methods; Middle Aged; Nursing science; Ostomy; Patient assessment; Patient Preference - psychology; Patient satisfaction; Patients; Personnel; perspective; Pilot projects; Preferences; Product development; Public; Quality of Life; questionnaire; Questionnaires; Reproducibility of Results; Security; Social Participation; Society; Socioeconomic Factors; states; Surgery; Surveys and questionnaires; Sweden; Technology Assessment, Biomedical - methods; Technology Assessment, Biomedical - standards; validation; Vårdvetenskap; Well being; Young Adult
• ISSN: 0266-4623; 1471-6348; 1471-6348
• DOI: 10.1017/S0266462317000848

Objectives: For medical devices, benefits other than direct clinical effects may have a large impact on the patients’ well-being, but a standardized method for measuring these benefits is unavailable. The objective was to explore potential patient benefits provided by medical devices, and to assess the relative preferences of these benefits in the general Swedish population. Methods: To identify attributes of patient benefit, healthcare personnel within a wide range of disease areas were interviewed. The generalized attributes were then validated among healthcare personnel, patient organizations, and manufacturers; in two pilot studies in the general population; and in two rounds of cognitive interviews. The general population's preferences of the attributes were measured with a usability-tested questionnaire in a final responding sample of 3,802 individuals, representative of the Swedish population. Results: Twenty attributes were identified, encompassing aspects of integrity, sense of security, social participation, and convenience. When measuring the relative preferences, the response rate was 37.0 percent, and the results showed that the attributes with the highest preferences concerned reliability, reduced need for assistance, and sense of control of the illness/disability. Conclusions: A set of twenty attributes of patient benefit relevant to users of medical devices was identified and validated. A questionnaire for patient-reported assessment of the benefits provided by a medical device was developed, based on the attributes. The questionnaire, designated MedTech20, provides a generic measurement method for the evaluation of medical devices used in a wide range of diseases/disabilities.