Skip to main content
Top
Published in: Health and Quality of Life Outcomes 1/2011

Open Access 01-12-2011 | Research

Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ)

Authors: Dorothy Keininger, Geoffroy Coteur

Published in: Health and Quality of Life Outcomes | Issue 1/2011

Login to get access

Abstract

Background

Subcutaneous self-injection of medication has benefits for the patient and healthcare system, but there are barriers such as dexterity problems and injection anxiety that can prevent self-injection being used effectively. An accurate method of evaluating patients' experiences with self-injection would enable assessment of their success in giving self-injections and the likelihood of them adhering to a self-injection regimen. The aim of this study was to develop a questionnaire to measure overall patient experience with subcutaneous self-injection (the Self-Injection Assessment Questionnaire [SIAQ]), and to investigate its psychometric properties.

Methods

The construct validity and reliability of the SIAQ were tested in patients with rheumatoid arthritis who volunteered to inject certolizumab pegol using a standard syringe during an open-label multinational extension trial of the long-term safety and efficacy of this drug. The SIAQ PRE module was self-completed before the first self-injection, and the POST module was self-completed following each of three fortnightly self-injections.

Results

Ninety-seven patients completed the SIAQ. All items correlated well with their respective domains in confirmatory factor analysis. As predicted, compared with other participants, patients with very low scores (less than 3 out of 10) in PRE causal domains (Feelings about injections and Self-confidence) were significantly less satisfied with their first self-injection, as were patients with a very low score in any POST causal domain (Self-confidence, Feelings about injections, Injection-site reactions and Ease of use), demonstrating known-groups validity. Causal domain scores generally correlated most strongly with the Satisfaction with self-injection domain, supporting convergent validity. The SIAQ demonstrated internal consistency and reproducibility; Cronbach's α and the test-retest coefficient were > 0.70 for all domains. Sensitivity and responsiveness were also shown, where measurable. Each language version showed structural validity.

Conclusion

The SIAQ was demonstrated to be a valid, reliable tool in patients with rheumatoid arthritis.
Appendix
Available only for authorised users
Literature
1.
go back to reference Sacks JJ, Helmick CG, Langmaid G: Deaths from arthritis and other rheumatic conditions, United States, 1979–1998. J Rheumatol 2004, 31: 1823–1828.PubMed Sacks JJ, Helmick CG, Langmaid G: Deaths from arthritis and other rheumatic conditions, United States, 1979–1998. J Rheumatol 2004, 31: 1823–1828.PubMed
2.
go back to reference Lee DM, Weinblatt ME: Rheumatoid arthritis. Lancet 2001, 358: 903–911. 10.1016/S0140-6736(01)06075-5PubMedCrossRef Lee DM, Weinblatt ME: Rheumatoid arthritis. Lancet 2001, 358: 903–911. 10.1016/S0140-6736(01)06075-5PubMedCrossRef
3.
go back to reference Mili F, Helmick CG, Moriarty DG: Health related quality of life among adults reporting arthritis: analysis of data from the Behavioral Risk Factor Surveillance System, US, 1996–99. J Rheumatol 2003, 30: 160–166.PubMed Mili F, Helmick CG, Moriarty DG: Health related quality of life among adults reporting arthritis: analysis of data from the Behavioral Risk Factor Surveillance System, US, 1996–99. J Rheumatol 2003, 30: 160–166.PubMed
4.
go back to reference Strand V, Singh JA: Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care 2007,13(Suppl 9):S237–251.PubMed Strand V, Singh JA: Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care 2007,13(Suppl 9):S237–251.PubMed
5.
go back to reference Donahue KE, Gartlehner G, Jonas DE, Lux LJ, Thieda P, Jonas BL, Hansen RA, Morgan LC, Lohr KN: Systematic review: comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis. Ann Intern Med 2008, 148: 124–134.PubMedCrossRef Donahue KE, Gartlehner G, Jonas DE, Lux LJ, Thieda P, Jonas BL, Hansen RA, Morgan LC, Lohr KN: Systematic review: comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis. Ann Intern Med 2008, 148: 124–134.PubMedCrossRef
6.
go back to reference Schwartzman S, Fleischmann R, Morgan GJ Jr: Do anti-TNF agents have equal efficacy in patients with rheumatoid arthritis? Arthritis Res Ther 2004,6(Suppl 2):S3-S11. 10.1186/ar1013PubMedCentralPubMedCrossRef Schwartzman S, Fleischmann R, Morgan GJ Jr: Do anti-TNF agents have equal efficacy in patients with rheumatoid arthritis? Arthritis Res Ther 2004,6(Suppl 2):S3-S11. 10.1186/ar1013PubMedCentralPubMedCrossRef
7.
go back to reference Kivitz A, Cohen S, Dowd JE, Edwards W, Thakker S, Wellborne FR, Renz CL, Segurado OG: Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial. Clin Ther 2006, 28: 1619–1629. 10.1016/j.clinthera.2006.10.006PubMedCrossRef Kivitz A, Cohen S, Dowd JE, Edwards W, Thakker S, Wellborne FR, Renz CL, Segurado OG: Clinical assessment of pain, tolerability, and preference of an autoinjection pen versus a prefilled syringe for patient self-administration of the fully human, monoclonal antibody adalimumab: the TOUCH trial. Clin Ther 2006, 28: 1619–1629. 10.1016/j.clinthera.2006.10.006PubMedCrossRef
8.
go back to reference Chilton F, Collett RA: Treatment choices, preferences and decision-making by patients with rheumatoid arthritis. Musculoskeletal Care 2008, 6: 1–14. 10.1002/msc.110PubMedCrossRef Chilton F, Collett RA: Treatment choices, preferences and decision-making by patients with rheumatoid arthritis. Musculoskeletal Care 2008, 6: 1–14. 10.1002/msc.110PubMedCrossRef
10.
go back to reference Hamm R, Patel B, Whittlestone T, Persad R: Patient self-injection: a new approach to administering luteinizing hormone-releasing hormone analogues. BJU Int 2000, 86: 840–842. 10.1046/j.1464-410x.2000.00910.xPubMedCrossRef Hamm R, Patel B, Whittlestone T, Persad R: Patient self-injection: a new approach to administering luteinizing hormone-releasing hormone analogues. BJU Int 2000, 86: 840–842. 10.1046/j.1464-410x.2000.00910.xPubMedCrossRef
11.
go back to reference Nir Y, Paz A, Sabo E, Potasman I: Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg 2003, 68: 341–344.PubMed Nir Y, Paz A, Sabo E, Potasman I: Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg 2003, 68: 341–344.PubMed
12.
go back to reference Willershausen B, Azrak A, Wilms S: Fear of dental treatment and its possible effects on oral health. Eur J Med Res 1999, 4: 72–77.PubMed Willershausen B, Azrak A, Wilms S: Fear of dental treatment and its possible effects on oral health. Eur J Med Res 1999, 4: 72–77.PubMed
13.
go back to reference Smolen JS, Landewe RB, Mease PJ, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff MH, Burmester GR, et al.: Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. Ann Rheum Dis 2009, 68: 797–804. 10.1136/ard.2008.101659PubMedCentralPubMedCrossRef Smolen JS, Landewe RB, Mease PJ, Brzezicki J, Mason D, Luijtens K, van Vollenhoven RF, Kavanaugh A, Schiff MH, Burmester GR, et al.: Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. Ann Rheum Dis 2009, 68: 797–804. 10.1136/ard.2008.101659PubMedCentralPubMedCrossRef
14.
go back to reference Turner RR, Quittner AL, Parasuraman BM, Kallich JD, Cleeland CS: Patient-reported outcomes: instrument development and selection issues. Value Health 2007,10(Suppl 2):S86–93. 10.1111/j.1524-4733.2007.00271.xPubMedCrossRef Turner RR, Quittner AL, Parasuraman BM, Kallich JD, Cleeland CS: Patient-reported outcomes: instrument development and selection issues. Value Health 2007,10(Suppl 2):S86–93. 10.1111/j.1524-4733.2007.00271.xPubMedCrossRef
16.
go back to reference Acquadro C, Conway K, Giroudet C, Mear I: Linguistic validation manual for patient-reported outcomes instruments. Lyon: Mapi Research Institute; 2004. Acquadro C, Conway K, Giroudet C, Mear I: Linguistic validation manual for patient-reported outcomes instruments. Lyon: Mapi Research Institute; 2004.
17.
go back to reference Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD: What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health 2007,10(Suppl 2):S94-S105. 10.1111/j.1524-4733.2007.00272.xPubMedCrossRef Frost MH, Reeve BB, Liepa AM, Stauffer JW, Hays RD: What is sufficient evidence for the reliability and validity of patient-reported outcome measures? Value Health 2007,10(Suppl 2):S94-S105. 10.1111/j.1524-4733.2007.00272.xPubMedCrossRef
18.
go back to reference Fang J: Medical statistics and computer experiments. Singapore: Stallion Press; 2005.CrossRef Fang J: Medical statistics and computer experiments. Singapore: Stallion Press; 2005.CrossRef
19.
go back to reference Bentler PM, Bonett DG: Significance tests and goodness-of-fit in the analysis of 22 covariance structures. Psychol Bull 1980, 88: 588–606. 10.1037/0033-2909.88.3.588CrossRef Bentler PM, Bonett DG: Significance tests and goodness-of-fit in the analysis of 22 covariance structures. Psychol Bull 1980, 88: 588–606. 10.1037/0033-2909.88.3.588CrossRef
20.
go back to reference Brown TA: Confirmatory factor analysis for applied research. 1st edition. New York: Guilford Press; 2006. Brown TA: Confirmatory factor analysis for applied research. 1st edition. New York: Guilford Press; 2006.
21.
go back to reference Jöreskog KG, Sörbom D: LISREL VI; Analysis of linear structural relationships by maximum likelihood, instrumental variables, and least squares. Uppsala: University of Uppsala; 1985. Jöreskog KG, Sörbom D: LISREL VI; Analysis of linear structural relationships by maximum likelihood, instrumental variables, and least squares. Uppsala: University of Uppsala; 1985.
22.
go back to reference Fayers PM, Machin D: Quality of life: assessment, analysis and interpretation. Chichester: John Wiley & Sons, Ltd; 2000.CrossRef Fayers PM, Machin D: Quality of life: assessment, analysis and interpretation. Chichester: John Wiley & Sons, Ltd; 2000.CrossRef
23.
go back to reference Ouwerkerk JW, van Pelt PA, Takken T, Helders PJ, Net J: Evaluating score distributions in the revised Dutch version of the Childhood Health Assessment Questionnaire. Pediatr Rheumatol Online J 2008, 6: 14. 10.1186/1546-0096-6-14PubMedCentralPubMedCrossRef Ouwerkerk JW, van Pelt PA, Takken T, Helders PJ, Net J: Evaluating score distributions in the revised Dutch version of the Childhood Health Assessment Questionnaire. Pediatr Rheumatol Online J 2008, 6: 14. 10.1186/1546-0096-6-14PubMedCentralPubMedCrossRef
24.
go back to reference Cronbach LJ: Coefficient alpha and the internal structure of tests. Psychometrika 1951, 16: 297–334. 10.1007/BF02310555CrossRef Cronbach LJ: Coefficient alpha and the internal structure of tests. Psychometrika 1951, 16: 297–334. 10.1007/BF02310555CrossRef
25.
go back to reference Nunnally JC, Bernstein I: Psychometric theory. 3rd edition. New York: McGraw-Hill; 1993. Nunnally JC, Bernstein I: Psychometric theory. 3rd edition. New York: McGraw-Hill; 1993.
26.
go back to reference Fitzpatrick R, Davey C, Buxton MJ, Jones DR: Evaluating patient-based outcome measures for use in clinical trials. Health Technology Assessment 1998, 2: 1–74.PubMed Fitzpatrick R, Davey C, Buxton MJ, Jones DR: Evaluating patient-based outcome measures for use in clinical trials. Health Technology Assessment 1998, 2: 1–74.PubMed
27.
go back to reference Nakagawa S, Cuthill IC: Effect size, confidence interval and statistical significance: a practical guide for biologists. Biol Rev Camb Philos Soc 2007, 82: 591–605. 10.1111/j.1469-185X.2007.00027.xPubMedCrossRef Nakagawa S, Cuthill IC: Effect size, confidence interval and statistical significance: a practical guide for biologists. Biol Rev Camb Philos Soc 2007, 82: 591–605. 10.1111/j.1469-185X.2007.00027.xPubMedCrossRef
28.
go back to reference Bruce B, Fries JF: The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol 2003, 30: 167–178.PubMed Bruce B, Fries JF: The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol 2003, 30: 167–178.PubMed
29.
go back to reference Keystone E, Heijde D, Mason D Jr, Landewe R, Vollenhoven RV, Combe B, Emery P, Strand V, Mease P, Desai C, et al.: Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 2008, 58: 3319–3329. 10.1002/art.23964PubMedCrossRef Keystone E, Heijde D, Mason D Jr, Landewe R, Vollenhoven RV, Combe B, Emery P, Strand V, Mease P, Desai C, et al.: Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum 2008, 58: 3319–3329. 10.1002/art.23964PubMedCrossRef
30.
go back to reference Fleischmann R, Vencovsky J, van Vollenhoven R, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V: Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis 2009, 68: 805–811. 10.1136/ard.2008.099291PubMedCentralPubMedCrossRef Fleischmann R, Vencovsky J, van Vollenhoven R, Borenstein D, Box J, Coteur G, Goel N, Brezinschek HP, Innes A, Strand V: Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis 2009, 68: 805–811. 10.1136/ard.2008.099291PubMedCentralPubMedCrossRef
31.
go back to reference Szeinbach SL, Barnes JH, Summers KH, Lenox SM: Development of an instrument to assess expectations of and preference for an insulin injection pen compared with the vial and syringe. Clin Ther 2004, 26: 590–597. 10.1016/S0149-2918(04)90061-6PubMedCrossRef Szeinbach SL, Barnes JH, Summers KH, Lenox SM: Development of an instrument to assess expectations of and preference for an insulin injection pen compared with the vial and syringe. Clin Ther 2004, 26: 590–597. 10.1016/S0149-2918(04)90061-6PubMedCrossRef
32.
go back to reference Green J, Kleinman L, Ciesla G, Huang J, Wintfeld N, Revicki D: Subcutaneous injection survey: psychometric evaluation of a treatment satisfaction instrument associated with a novel HIV medication. HIV Clin Trials 2002, 3: 387–395. 10.1310/TT4M-WKFF-JTJ7-VQU6PubMedCrossRef Green J, Kleinman L, Ciesla G, Huang J, Wintfeld N, Revicki D: Subcutaneous injection survey: psychometric evaluation of a treatment satisfaction instrument associated with a novel HIV medication. HIV Clin Trials 2002, 3: 387–395. 10.1310/TT4M-WKFF-JTJ7-VQU6PubMedCrossRef
33.
go back to reference Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH: Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes 2009, 7: 21. 10.1186/1477-7525-7-21PubMedCentralPubMedCrossRef Chevat C, Viala-Danten M, Dias-Barbosa C, Nguyen VH: Development and psychometric validation of a self-administered questionnaire assessing the acceptance of influenza vaccination: the Vaccinees' Perception of Injection (VAPI) questionnaire. Health Qual Life Outcomes 2009, 7: 21. 10.1186/1477-7525-7-21PubMedCentralPubMedCrossRef
34.
go back to reference Mollema ED, Snoek FJ, Pouwer F, Heine RJ, van der Ploeg HM: Diabetes Fear of Injecting and Self-Testing Questionnaire: a psychometric evaluation. Diabetes Care 2000, 23: 765–769. 10.2337/diacare.23.6.765PubMedCrossRef Mollema ED, Snoek FJ, Pouwer F, Heine RJ, van der Ploeg HM: Diabetes Fear of Injecting and Self-Testing Questionnaire: a psychometric evaluation. Diabetes Care 2000, 23: 765–769. 10.2337/diacare.23.6.765PubMedCrossRef
35.
go back to reference Snoek FJ, Mollema ED, Heine RJ, Bouter LM, van der Ploeg HM: Development and validation of the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ): first findings. Diabet Med 1997, 14: 871–876. 10.1002/(SICI)1096-9136(199710)14:10<871::AID-DIA457>3.0.CO;2-YPubMedCrossRef Snoek FJ, Mollema ED, Heine RJ, Bouter LM, van der Ploeg HM: Development and validation of the Diabetes Fear of Injecting and Self-Testing Questionnaire (D-FISQ): first findings. Diabet Med 1997, 14: 871–876. 10.1002/(SICI)1096-9136(199710)14:10<871::AID-DIA457>3.0.CO;2-YPubMedCrossRef
36.
go back to reference Guadagnoli E, Velicer WF: Relation of sample size to the stability of component patterns. Psychol Bull 1988, 103: 265–275. 10.1037/0033-2909.103.2.265PubMedCrossRef Guadagnoli E, Velicer WF: Relation of sample size to the stability of component patterns. Psychol Bull 1988, 103: 265–275. 10.1037/0033-2909.103.2.265PubMedCrossRef
37.
go back to reference Locker D, Jokovic A, Allison P: Direction of wording and responses to items in oral health-related quality of life questionnaires for children and their parents. Community Dent Oral Epidemiol 2007, 35: 255–262. 10.1111/j.1600-0528.2007.00320.xPubMedCrossRef Locker D, Jokovic A, Allison P: Direction of wording and responses to items in oral health-related quality of life questionnaires for children and their parents. Community Dent Oral Epidemiol 2007, 35: 255–262. 10.1111/j.1600-0528.2007.00320.xPubMedCrossRef
Metadata
Title
Assessment of self-injection experience in patients with rheumatoid arthritis: psychometric validation of the Self-Injection Assessment Questionnaire (SIAQ)
Authors
Dorothy Keininger
Geoffroy Coteur
Publication date
01-12-2011
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2011
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/1477-7525-9-2

Other articles of this Issue 1/2011

Health and Quality of Life Outcomes 1/2011 Go to the issue