DEVELOPMENT, PILOT TESTING, SCORING AND VALIDATION OF A MANAGEMENT TOOL FOR PATIENTS UNDERGOING SPECIFIC IMMUNO-THERAPY
Author(s)
Arnould B1, Benmedjahed K2, Fadel R3, Bos C3, Fontaine JF4, Haddad T5, Mathelier Fusade P5, Rufin P5, Saint Martin F6, Zekri J7, Viala M21Mapi Values, Lyon, Rhone, France; 2 Mapi Values, Lyon, France; 3 Stallergènes, Antony, France; 4 Private practice, Reims, France; 5 Private practice, Paris, France; 6 Private practice, Villebon sur Yvette, France; 7 Private practice, Toulouse, France
OBJECTIVES: Clinicians in charge of allergic rhinitis patients miss specific questionnaires assessing patients' expectations, satisfaction, adherence, persistence, attitudes toward Specific Immuno-therapy (SIT). Our aim was to provide them with a specific instrument allowing to better adapt care to the patient's characteristics, perceptions and behaviour. METHODS: A conceptual model was identified from a literature review, 5 clinician and 21 patient interviews. A test version of the questionnaire was developed and independently validated by an Advisory Committee (AC). Five patients suffering from allergic rhinitis and treated by SIT completed the questionnaire and were asked to comment the questionnaire in-depth. It was redrafted and included in a pilot study (10 clinicians, 30 patients) in real conditions of use. A revised questionnaire was administrated by 211 clinicians to 571 patients (380 having a SIT and 191 about to) between February and May 2005 in a cross-sectional, observational study. RESULTS: Fourteen global and 57 detailed concepts were included in the conceptual model. The test questionnaire contained 64 items. After cognitive debriefing, 7 items were excluded. The questionnaire was well-accepted by the patients in the pilot study. Clinicians were delighted to have a helpful patient-management tool. The pilot questionnaire contained 52 items in 10 sections (symptoms, allergy in daily life, motivations for SIT, advantages, constraints, intake, outcomes, satisfaction, intention, information). The majority of the 211 clinicians reported high patient acceptability and major interest in using the questionnaire routinely. The items presenting missing data, not clearly related to a specific domain, or redundant were not selected for final format and score calculation. The scores were assessed for internal consistency reliability, construct validity and predictive validity. CONCLUSION: This instrument covers the major domains impacting the patient's persistence in SIT. It is a promising patient-management tool for use in clinical practice.
Conference/Value in Health Info
2005-11, ISPOR Europe 2005, Florence, Italy
Value in Health, Vol. 8, No.6 (November/December 2005)
Code
PAL3
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Respiratory-Related Disorders