Skip to main content
Top
Published in: The Patient - Patient-Centered Outcomes Research 3/2017

Open Access 01-06-2017 | Original Research Article

Development and Content Validity of the Statin Experience Assessment Questionnaire (SEAQ)©

Authors: Terry A. Jacobson, Steven V. Edelman, Nina Galipeau, Alan L. Shields, Usha G. Mallya, Andrew Koren, Michael H. Davidson

Published in: The Patient - Patient-Centered Outcomes Research | Issue 3/2017

Login to get access

Abstract

Introduction

The National Lipid Association Statin Intolerance (SI) Panel recognized the need for better understanding of the patient SI experience.

Objective

The objective of this research was to develop a patient-reported outcome (PRO) questionnaire to assess a patient’s experience with SI.

Methods

Questionnaire development was informed via a series of research activities: literature review, concept elicitation, item generation, and content evaluation. Following the literature review and concept elicitation, a draft questionnaire was constructed and subsequently modified based on feedback from therapeutic area experts and patients via cognitive debriefing interviews.

Results

Muscle-related symptoms were the most commonly reported symptoms associated with SI in the literature review (35 of 41 articles reviewed [85%]) and in semi-structured interviews with experts (n = 5 [100%]) and patients (n = 17 of 20 [85.0%]). Physical and other impacts of SI symptoms on daily activities were also frequently reported. A 17-item draft questionnaire was created, and cognitive debriefing with experts (n = 5) and patients (n = 15) was conducted. Overall, the items, response options, and instructions were comprehensible and positively reviewed; minor changes resulted in the 15-item Statin Experience Assessment Questionnaire (SEAQ)©. Using a 30-day recall period, the SEAQ© assesses the severity and impact of six SI symptoms (muscle ache, muscle pain, muscle cramps, muscle weakness, tiredness, and joint pain) on an 11-point numeric scale. Statin discontinuation and likelihood of discontinuation due to symptoms are assessed and scored on a yes/no and five-point verbal response scale, respectively.

Conclusion

The SEAQ© is a novel content-valid PRO questionnaire that assesses patient SI experience and fosters dialogue about SI between patients and providers.
Appendix
Available only for authorised users
Literature
2.
go back to reference Anderson TJ, Grégoire J, Hegele RA, Couture P, Mancini GB, McPherson R, et al. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013;29(2):151–67. doi:10.1016/j.cjca.2012.11.032.CrossRefPubMed Anderson TJ, Grégoire J, Hegele RA, Couture P, Mancini GB, McPherson R, et al. 2012 update of the Canadian Cardiovascular Society guidelines for the diagnosis and treatment of dyslipidemia for the prevention of cardiovascular disease in the adult. Can J Cardiol. 2013;29(2):151–67. doi:10.​1016/​j.​cjca.​2012.​11.​032.CrossRefPubMed
3.
go back to reference European Association for Cardiovascular Prevention & Rehabilitation. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32(14):1769–818. doi:10.1093/eurheartj/ehr158.CrossRef European Association for Cardiovascular Prevention & Rehabilitation. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011;32(14):1769–818. doi:10.​1093/​eurheartj/​ehr158.CrossRef
5.
go back to reference Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2889–934. doi:10.1016/j.jacc.2013.11.002. Stone NJ, Robinson JG, Lichtenstein AH, Bairey Merz CN, Blum CB, Eckel RH, et al. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014;63(25 Pt B):2889–934. doi:10.​1016/​j.​jacc.​2013.​11.​002.
6.
go back to reference Teramoto T, Sasaki J, Ishibashi S, Birou S, Daida H, Dohi S, et al. Treatment B) drug therapy: executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan—2012 version. J Atheroscler Thromb. 2013;20(12):850–60. doi:10.5551/jat.19166.CrossRefPubMed Teramoto T, Sasaki J, Ishibashi S, Birou S, Daida H, Dohi S, et al. Treatment B) drug therapy: executive summary of the Japan Atherosclerosis Society (JAS) guidelines for the diagnosis and prevention of atherosclerotic cardiovascular diseases in Japan—2012 version. J Atheroscler Thromb. 2013;20(12):850–60. doi:10.​5551/​jat.​19166.CrossRefPubMed
7.
go back to reference Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol. 2014;21(4):464–74. doi:10.1177/2047487314525531.CrossRefPubMed Finegold JA, Manisty CH, Goldacre B, Barron AJ, Francis DP. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. Eur J Prev Cardiol. 2014;21(4):464–74. doi:10.​1177/​2047487314525531​.CrossRefPubMed
9.
11.
12.
go back to reference El-Salem K, Ababneh B, Rudnicki S, Malkawi A, Alrefai A, Khader Y, et al. Prevalence and risk factors of muscle complications secondary to statins. Muscle Nerve. 2011;44(6):877–81. doi:10.1002/mus.22205.CrossRefPubMed El-Salem K, Ababneh B, Rudnicki S, Malkawi A, Alrefai A, Khader Y, et al. Prevalence and risk factors of muscle complications secondary to statins. Muscle Nerve. 2011;44(6):877–81. doi:10.​1002/​mus.​22205.CrossRefPubMed
18.
go back to reference Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, et al. Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J. 2015;36(17):1012–22. doi:10.1093/eurheartj/ehv043.CrossRefPubMedPubMedCentral Stroes ES, Thompson PD, Corsini A, Vladutiu GD, Raal FJ, Ray KK, et al. Statin-associated muscle symptoms: impact on statin therapy—European Atherosclerosis Society Consensus Panel Statement on Assessment, Aetiology and Management. Eur Heart J. 2015;36(17):1012–22. doi:10.​1093/​eurheartj/​ehv043.CrossRefPubMedPubMedCentral
19.
go back to reference Sanchez RJ, Graham JH, Evans MA, Mallya UG, Panaccio MP, Steinhubl SR. Clinical and economic consequences of statin intolerance in the U.S.: Results from an integrated health system [abstract]. Circ Cardiovasc Qual Outcomes. 2015;8(Suppl 2):A146. Sanchez RJ, Graham JH, Evans MA, Mallya UG, Panaccio MP, Steinhubl SR. Clinical and economic consequences of statin intolerance in the U.S.: Results from an integrated health system [abstract]. Circ Cardiovasc Qual Outcomes. 2015;8(Suppl 2):A146.
21.
go back to reference Peterson ED, Ho PM, Barton M, Beam C, Burgess LH, Casey DE Jr, et al. ACC/AHA/AACVPR/AAFP/ANA concepts for clinician-patient shared accountability in performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2014;64(20):2133–45. doi:10.1016/j.jacc.2014.09.003.CrossRefPubMedPubMedCentral Peterson ED, Ho PM, Barton M, Beam C, Burgess LH, Casey DE Jr, et al. ACC/AHA/AACVPR/AAFP/ANA concepts for clinician-patient shared accountability in performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Cardiol. 2014;64(20):2133–45. doi:10.​1016/​j.​jacc.​2014.​09.​003.CrossRefPubMedPubMedCentral
23.
go back to reference Lamoureux RE, Shields A, Stokes J, Yaworsky A, Galipeau N. How many subjects are enough for symptom-focused concept elicitation studies? A retrospective analysis of saturation across twenty-six studies [abstract]. Value Health. 2015;18(3):A33. doi:10.1016/j.jval.2015.03.198.CrossRef Lamoureux RE, Shields A, Stokes J, Yaworsky A, Galipeau N. How many subjects are enough for symptom-focused concept elicitation studies? A retrospective analysis of saturation across twenty-six studies [abstract]. Value Health. 2015;18(3):A33. doi:10.​1016/​j.​jval.​2015.​03.​198.CrossRef
24.
go back to reference Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. 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 1—eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967–77. doi:10.1016/j.jval.2011.06.014.CrossRefPubMed Patrick DL, Burke LB, Gwaltney CJ, Leidy NK, Martin ML, Molsen E, et al. 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 1—eliciting concepts for a new PRO instrument. Value Health. 2011;14(8):967–77. doi:10.​1016/​j.​jval.​2011.​06.​014.CrossRefPubMed
25.
go back to reference Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health. 2009;12(8):1075–83. doi:10.1111/j.1524-4733.2009.00603.x.CrossRefPubMed Rothman M, Burke L, Erickson P, Leidy NK, Patrick DL, Petrie CD. Use of existing patient-reported outcome (PRO) instruments and their modification: the ISPOR Good Research Practices for Evaluating and Documenting Content Validity for the Use of Existing Instruments and Their Modification PRO Task Force Report. Value Health. 2009;12(8):1075–83. doi:10.​1111/​j.​1524-4733.​2009.​00603.​x.CrossRefPubMed
26.
go back to reference Friese S. ATLAS ti 7 User Manual. Berlin: ATLASti Scientific Software Development GmbH; 2013. Friese S. ATLAS ti 7 User Manual. Berlin: ATLASti Scientific Software Development GmbH; 2013.
27.
go back to reference Abdulrazzaq HA, Sulaiman SAS. Prediction of renal impairment induced by statin therapy in cardiac outpatients. Int J Pharm Pharm Sci. 2012;4(Suppl 1):371–3. Abdulrazzaq HA, Sulaiman SAS. Prediction of renal impairment induced by statin therapy in cardiac outpatients. Int J Pharm Pharm Sci. 2012;4(Suppl 1):371–3.
28.
go back to reference Abdulrazzaq HA, Sulaiman SAS. Neurological adverse drug reactions and statin therapy. Int J Pharm Pharm Sci. 2012;4:446–9. Abdulrazzaq HA, Sulaiman SAS. Neurological adverse drug reactions and statin therapy. Int J Pharm Pharm Sci. 2012;4:446–9.
31.
go back to reference Baykal D. An update on statin safety with an emphasis on differences. LipidSpin. 2013;11:5–8. Baykal D. An update on statin safety with an emphasis on differences. LipidSpin. 2013;11:5–8.
35.
go back to reference Chee YJ, Chan HHV, Tan NC. Understanding patients’ perspective of statin therapy: can we design a better approach to the management of dyslipidaemia? A literature review. Singapore Med J. 2014;55(8):416–21. doi:10.11622/smedj.2014099.CrossRef Chee YJ, Chan HHV, Tan NC. Understanding patients’ perspective of statin therapy: can we design a better approach to the management of dyslipidaemia? A literature review. Singapore Med J. 2014;55(8):416–21. doi:10.​11622/​smedj.​2014099.CrossRef
36.
go back to reference Cho L, Rocco M, Colquhoun D, Sullivan D, Rosenson RS, Dent R, et al. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy. Clin Cardiol. 2014;37(3):131–9. doi:10.1002/clc.22248.CrossRefPubMed Cho L, Rocco M, Colquhoun D, Sullivan D, Rosenson RS, Dent R, et al. Design and rationale of the GAUSS-2 study trial: a double-blind, ezetimibe-controlled phase 3 study of the efficacy and tolerability of evolocumab (AMG 145) in subjects with hypercholesterolemia who are intolerant of statin therapy. Clin Cardiol. 2014;37(3):131–9. doi:10.​1002/​clc.​22248.CrossRefPubMed
42.
go back to reference Friedrich DA. Vitamin D deficiency and statin intolerance. LipidSpin. 2013;11:21–2. Friedrich DA. Vitamin D deficiency and statin intolerance. LipidSpin. 2013;11:21–2.
43.
go back to reference Fujimoto M, Hosomi K, Takada M. Statin-associated lower urinary tract symptoms: data mining of the public version of the FDA adverse event reporting system, FAERS. Int J Clin Pharmacol Ther. 2014;52(4):259–66. doi:10.5414/CP202033.CrossRefPubMed Fujimoto M, Hosomi K, Takada M. Statin-associated lower urinary tract symptoms: data mining of the public version of the FDA adverse event reporting system, FAERS. Int J Clin Pharmacol Ther. 2014;52(4):259–66. doi:10.​5414/​CP202033.CrossRefPubMed
46.
go back to reference Harrison TN, Derose SF, Cheetham TC, Chiu V, Vansomphone SS, Green K, et al. Primary nonadherence to statin therapy: patients’ perceptions. Am J Manag Care. 2013;19(4):e133–9.PubMed Harrison TN, Derose SF, Cheetham TC, Chiu V, Vansomphone SS, Green K, et al. Primary nonadherence to statin therapy: patients’ perceptions. Am J Manag Care. 2013;19(4):e133–9.PubMed
48.
go back to reference Li JH, Joy SV, Haga SB, Orlando LA, Kraus WE, Ginsburg GS, et al. Genetically guided statin therapy on statin perceptions, adherence, and cholesterol lowering: a pilot implementation study in primary care patients. J Pers Med. 2014;4(2):147–62. doi:10.3390/jpm4020147.CrossRefPubMedPubMedCentral Li JH, Joy SV, Haga SB, Orlando LA, Kraus WE, Ginsburg GS, et al. Genetically guided statin therapy on statin perceptions, adherence, and cholesterol lowering: a pilot implementation study in primary care patients. J Pers Med. 2014;4(2):147–62. doi:10.​3390/​jpm4020147.CrossRefPubMedPubMedCentral
52.
go back to reference Nair RK, Karadi RL, Kirpatrick ES. Managing patients with ‘statin intolerance’: a retrospective study. Br J Cardiol. 2008;15(3):158–60. Nair RK, Karadi RL, Kirpatrick ES. Managing patients with ‘statin intolerance’: a retrospective study. Br J Cardiol. 2008;15(3):158–60.
53.
go back to reference Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C, et al. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. J Am Coll Cardiol. 2002;40(3):567–72.CrossRefPubMed Pasternak RC, Smith SC Jr, Bairey-Merz CN, Grundy SM, Cleeman JI, Lenfant C, et al. ACC/AHA/NHLBI clinical advisory on the use and safety of statins. J Am Coll Cardiol. 2002;40(3):567–72.CrossRefPubMed
54.
go back to reference Roberto G, Biagi C, Montanaro N, Koci A, Moretti U, Motola D. Statin-associated gynecomastia: evidence coming from the Italian spontaneous ADR reporting database and literature. Eur J Clin Pharmacol. 2012;68(6):1007–11. doi:10.1007/s00228-012-1218-5.CrossRefPubMed Roberto G, Biagi C, Montanaro N, Koci A, Moretti U, Motola D. Statin-associated gynecomastia: evidence coming from the Italian spontaneous ADR reporting database and literature. Eur J Clin Pharmacol. 2012;68(6):1007–11. doi:10.​1007/​s00228-012-1218-5.CrossRefPubMed
60.
go back to reference Tuccori M, Lapi F, Testi A, Coli D, Moretti U, Vannacci A, et al. Statin-associated psychiatric adverse events: a case/non-case evaluation of an Italian database of spontaneous adverse drug reaction reporting. Drug Saf. 2008;31(12):1115–23. doi:10.2165/0002018-200831120-00007.CrossRefPubMed Tuccori M, Lapi F, Testi A, Coli D, Moretti U, Vannacci A, et al. Statin-associated psychiatric adverse events: a case/non-case evaluation of an Italian database of spontaneous adverse drug reaction reporting. Drug Saf. 2008;31(12):1115–23. doi:10.​2165/​0002018-200831120-00007.CrossRefPubMed
61.
go back to reference Wei MY, Ito MK, Cohen JD, Brinton EA, Jacobson TA. Predictors of statin adherence, switching, and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013;7(5):472–83. doi:10.1016/j.jacl.2013.03.001.CrossRefPubMed Wei MY, Ito MK, Cohen JD, Brinton EA, Jacobson TA. Predictors of statin adherence, switching, and discontinuation in the USAGE survey: understanding the use of statins in America and gaps in patient education. J Clin Lipidol. 2013;7(5):472–83. doi:10.​1016/​j.​jacl.​2013.​03.​001.CrossRefPubMed
62.
go back to reference Welding JM, Ragheb B. Evidence-based approach to the use of CoQ10 to deal with statin intolerance. LipidSpin. 2013;11(4):13–4. Welding JM, Ragheb B. Evidence-based approach to the use of CoQ10 to deal with statin intolerance. LipidSpin. 2013;11(4):13–4.
64.
go back to reference Zetia [package insert]. Whitehouse Station: Merck and Co; 2013. Zetia [package insert]. Whitehouse Station: Merck and Co; 2013.
65.
go back to reference Lipitor [package insert]. New York: Pfizer; 2015. Lipitor [package insert]. New York: Pfizer; 2015.
66.
go back to reference Vytorin [package insert]. Whitehouse Station: Merck and Co; 2015. Vytorin [package insert]. Whitehouse Station: Merck and Co; 2015.
69.
72.
go back to reference Burke LB, Kennedy DL, Miskala PH, Papadopoulos EJ, Trentacosti AM. The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther. 2008;84(2):281–3. doi:10.1038/clpt.2008.128.CrossRefPubMed Burke LB, Kennedy DL, Miskala PH, Papadopoulos EJ, Trentacosti AM. The use of patient-reported outcome measures in the evaluation of medical products for regulatory approval. Clin Pharmacol Ther. 2008;84(2):281–3. doi:10.​1038/​clpt.​2008.​128.CrossRefPubMed
73.
go back to reference Kerr C, Nixon A, Wild D. Assessing and demonstrating data saturation in qualitative inquiry supporting patient-reported outcomes research. Expert Rev Pharmacoecon Outcomes Res. 2010;10(3):269–81. doi:10.1586/erp.10.30.CrossRefPubMed Kerr C, Nixon A, Wild D. Assessing and demonstrating data saturation in qualitative inquiry supporting patient-reported outcomes research. Expert Rev Pharmacoecon Outcomes Res. 2010;10(3):269–81. doi:10.​1586/​erp.​10.​30.CrossRefPubMed
Metadata
Title
Development and Content Validity of the Statin Experience Assessment Questionnaire (SEAQ)©
Authors
Terry A. Jacobson
Steven V. Edelman
Nina Galipeau
Alan L. Shields
Usha G. Mallya
Andrew Koren
Michael H. Davidson
Publication date
01-06-2017
Publisher
Springer International Publishing
Published in
The Patient - Patient-Centered Outcomes Research / Issue 3/2017
Print ISSN: 1178-1653
Electronic ISSN: 1178-1661
DOI
https://doi.org/10.1007/s40271-016-0211-y

Other articles of this Issue 3/2017

The Patient - Patient-Centered Outcomes Research 3/2017 Go to the issue
Live Webinar | 27-06-2024 | 18:00 (CEST)

Keynote webinar | Spotlight on medication adherence

Live: Thursday 27th June 2024, 18:00-19:30 (CEST)

WHO estimates that half of all patients worldwide are non-adherent to their prescribed medication. The consequences of poor adherence can be catastrophic, on both the individual and population level.

Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.

Prof. Kevin Dolgin
Prof. Florian Limbourg
Prof. Anoop Chauhan
Developed by: Springer Medicine
Obesity Clinical Trial Summary

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.

Developed by: Springer Medicine