Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire

Catherine Chevat, Muriel Viala-Danten, Carla Dias-Barbosa, Van Hung Nguyen, Catherine Chevat, Muriel Viala-Danten, Carla Dias-Barbosa, Van Hung Nguyen

Abstract

Background: Influenza is among the most common infectious diseases. The main protection against influenza is vaccination. A self-administered questionnaire was developed and validated for use in clinical trials to assess subjects' perception and acceptance of influenza vaccination and its subsequent injection site reactions (ISR).

Methods: The VAPI questionnaire was developed based on interviews with vaccinees. The initial version was administered to subjects in international clinical trials comparing intradermal with intramuscular influenza vaccination. Item reduction and scale construction were carried out using principal component and multitrait analyses (n = 549). Psychometric validation of the final version was conducted per country (n = 5,543) and included construct and clinical validity and internal consistency reliability. All subjects gave their written informed consent before being interviewed or included in the clinical studies.

Results: The final questionnaire comprised 4 dimensions ("bother from ISR"; "arm movement"; "sleep"; "acceptability") grouping 16 items, and 5 individual items (anxiety before vaccination; bother from pain during vaccination; satisfaction with injection system; willingness to be vaccinated next year; anxiety about vaccination next year). Construct validity was confirmed for all scales in most of the countries. Internal consistency reliability was good for all versions (Cronbach's alpha ranging from 0.68 to 0.94), as was clinical validity: scores were positively correlated with the severity of ISR and pain.

Conclusion: The VAPI questionnaire is a valid and reliable tool, assessing the acceptance of vaccine injection and reactions following vaccination.

Trial registration: ClinicalTrials.gov NCT00258934 NCT00383526 NCT00383539.

Figures

Figure 1
Figure 1
Conceptual framework.
Figure 2
Figure 2
VAPI scores according to maximum severity of pain reported for 8 days after injection. Mean scores and standard deviation of the mean (STDm); p = p-value of Kruskal-Wallis test; N = 6,092.
Figure 3
Figure 3
VAPI scores according to maximum severity of erythema reported for 8 days after injection. Mean scores and standard deviation of the mean (STDm); p = p-value of Kruskal-Wallis test; N = 6,092.

References

    1. Influenza. 2008.
    1. Glezen WP, Couch RB. Interpandemic influenza in the Houston area, 1974–76. N Engl J Med. 1978;298:587–592.
    1. Glezen WP, Greenberg SB, Atmar RL, Piedra PA, Couch RB. Impact of respiratory virus infections on persons with chronic underlying conditions. JAMA. 2000;283:499–505. doi: 10.1001/jama.283.4.499.
    1. Monto AS, Kioumehr F. The Tecumseh Study of Respiratory Illness. IX. Occurence of influenza in the community, 1966–1971. Am J Epidemiol. 1975;102:553–563.
    1. Barker WH. Excess pneumonia and influenza associated hospitalization during influenza epidemics in the United States, 1970–78. Am J Public Health. 1986;76:761–765. doi: 10.2105/AJPH.76.7.761.
    1. Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003;289:179–186. doi: 10.1001/jama.289.2.179.
    1. Bridges CB, Thompson WW, Meltzer MI, Reeve GR, Talamonti WJ, Cox NJ, Lilac HA, Hall H, Klimov A, Fukuda K. Effectiveness and cost-benefit of influenza vaccination of healthy working adults: A randomized controlled trial. JAMA. 2000;284:1655–1663. doi: 10.1001/jama.284.13.1655.
    1. Nichol KL, Lind A, Margolis KL, Murdoch M, McFadden R, Hauge M, Magnan S, Drake M. The effectiveness of vaccination against influenza in healthy, working adults. N Engl J Med. 1995;333:889–893. doi: 10.1056/NEJM199510053331401.
    1. Fiore AE, Shay DK, Broder K, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NS. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2008. MMWR Recomm Rep. 2008;57:1–60.
    1. Start of "influenza season". 2008.
    1. Hak E, Nordin J, Wei F, Mullooly J, Poblete S, Strikas R, Nichol KL. Influence of high-risk medical conditions on the effectiveness of influenza vaccination among elderly members of 3 large managed-care organizations. Clin Infect Dis. 2002;35:370–377. doi: 10.1086/341403.
    1. Nichol KL, Margolis KL, Wouremna J, von ST. Effectiveness of influenza vaccine in the elderly. Gerontology. 1996;42:274–279.
    1. Nichol KL, Wuorenma J, von ST. Benefits of influenza vaccination for low-, intermediate-, and high-risk senior citizens. Arch Intern Med. 1998;158:1769–1776. doi: 10.1001/archinte.158.16.1769.
    1. Nichol KL. Influenza vaccination in the elderly: impact on hospitalisation and mortality. Drugs Aging. 2005;22:495–515. doi: 10.2165/00002512-200522060-00004.
    1. Glenn GM, Scharton-Kersten T, Alving CR. Advances in vaccine delivery: transcutaneous immunisation. Expert Opin Investig Drugs. 1999;8:797–805. doi: 10.1517/13543784.8.6.797.
    1. Mereckiene J, Cotter S, Nicoll A, Levy-Bruhl D, Ferro A, Tridente G, Zanoni G, Berra P, Salmaso S, O'Flanagan D, et al. National seasonal influenza vaccination survey in Europe, 2008. Euro Surveill. 2008;13:pii–19017.
    1. Brooks JH, Criep LH, Ruben FL. Intradermal administration of bivalent and monovalent influenza vaccines. Ann Allergy. 1977;39:110–112.
    1. Halperin W, Weiss WI, Altman R, Diamond MA, Black KJ, Iaci AW, Black HC, Goldfield M. A comparison of the intradermal and subcutaneous routes of influenza vaccination with A/New Jersey/76 (swine flu) and A/Victoria/75: report of a study and review of the literature. Am J Public Health. 1979;69:1247–1251. doi: 10.2105/AJPH.69.12.1247.
    1. Alarcon JB, Hartley AW, Harvey NG, Mikszta JA. Preclinical evaluation of microneedle technology for intradermal delivery of influenza vaccines. Clin Vaccine Immunol. 2007;14:375–381. doi: 10.1128/CVI.00387-06.
    1. Belshe RB, Newman FK, Cannon J, Duane C, Treanor J, Van HC, Howe BJ, Dubin G. Serum antibody responses after intradermal vaccination against influenza. N Engl J Med. 2004;351:2286–2294. doi: 10.1056/NEJMoa043555.
    1. Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004;351:2295–2301. doi: 10.1056/NEJMoa043540.
    1. Nicolas JF, Guy B. Intradermal, epidermal and transcutaneous vaccination: from immunology to clinical practice. Expert Rev Vaccines. 2008;7:1201–1214. doi: 10.1586/14760584.7.8.1201.
    1. Holland D, Booy R, De LF, Eizenberg P, McDonald J, Karrasch J, McKeirnan M, Salem H, Mills G, Reid J, et al. Intradermal influenza vaccine administered using a new microinjection system produces superior immunogenicity in elderly adults: a randomized controlled trial. J Infect Dis. 2008;198:650–658. doi: 10.1086/590434.
    1. al-Mazrou A, Scheifele DW, Soong T, Bjornson G. Comparison of adverse reactions to whole-virion and split-virion influenza vaccines in hospital personnel. CMAJ. 1991;145:213–218.
    1. Allsup SJ, Gosney M, Regan M, Haycox A, Fear S, Johnstone FC. Side effects of influenza vaccination in healthy older people: a randomised single-blind placebo-controlled trial. Gerontology. 2001;47:311–314. doi: 10.1159/000052820.
    1. Govaert TM, Dinant GJ, Aretz K, Masurel N, Sprenger MJ, Knottnerus JA. Adverse reactions to influenza vaccine in elderly people: randomised double blind placebo controlled trial. BMJ. 1993;307:988–990.
    1. Staquet MJ, Hays RD, Fayers PM. Quality of Life Assessment ine Clinical Trials: Methods and Practice. Oxford: Oxford University Press; 1998.
    1. Campbell DT, Fiske DW. Convergent and discriminant validation by the multitrait-multimethod matrix. Psychol Bull. 1959;56:81–105. doi: 10.1037/h0046016.
    1. Hays RD, Hayashi T. Beyond internal consistency reliability: rationale and user's guide for Multitrait analysis program on the microcomputer. Behav Res Methods Instrum Comput. 1990;22:167–175.
    1. Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N. Patient-reported outcomes: The example of health-related quality of life: A European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J. 2002;36:209–238.
    1. Cronbach LJ. Coefficient Alpha and the Internal Structure of Tests. Psychometrika. 1951;16:297–334. doi: 10.1007/BF02310555.
    1. Nunnally JC, Bernstein IH. Psychometric theory. New York: McGraw-Hill Inc; 1994.
    1. Hannoun C, Megas F, Piercy J. Immunogenicity and protective efficacy of influenza vaccination. Virus Res. 2004;103:133–138. doi: 10.1016/j.virusres.2004.02.025.
    1. Blue CL, Valley JM. Predictors of influenza vaccine. Acceptance among healthy adult workers. AAOHN J. 2002;50:227–233.
    1. Bovier PA, Chamot E, Bouvier GM, Loutan L. Importance of patients' perceptions and general practitioners' recommendations in understanding missed opportunities for immunisations in Swiss adults. Vaccine. 2001;19:4760–4767. doi: 10.1016/S0264-410X(01)00223-7.
    1. Chapman GB, Coups EJ. Predictors of influenza vaccine acceptance among healthy adults. Prev Med. 1999;29:249–262. doi: 10.1006/pmed.1999.0535.
    1. Evans MR, Prout H, Prior L, Tapper-Jones LM, Butler CC. A qualitative study of lay beliefs about influenza immunisation in older people. Br J Gen Pract. 2007;57:352–358.
    1. Fiebach NH, Viscoli CM. Patient acceptance of influenza vaccination. Am J Med. 1991;91:393–400. doi: 10.1016/0002-9343(91)90157-S.
    1. Delore V, Salamand C, Marsh G, Arnoux S, Pepin S, Saliou P. Long-term clinical trial safety experience with the inactivated split influenza vaccine, Vaxigrip. Vaccine. 2006;24:1586–1592. doi: 10.1016/j.vaccine.2005.10.008.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe