PERSYVE - Design and validation of a questionnaire about adverse effects of antihypertensive drugs

  • Daniela Duarte-Silva
  • Adolfo Figueiras
  • Maria T. Herdeiro
  • Antonio Teixeira Rodrigues
  • Fabio Silva Branco
  • Jorge Polonia
  • Isabel V. Figueiredo
Keywords: Antihypertensive Agents, Drug-Related Side Effects and Adverse Reactions, Medication Adherence, Questionnaires, Validation Studies as Topic, Portugal


Objective: The aim of this study was to design and validate a questionnaire to measure perceived symptoms associated with antihypertensive drugs (PERSYVE).

Methods: The PERSYVE development and validation included four stages: 1) item development (bibliographic review and questionnaire elaboration); 2) face and content validation; 3) field testing (pre-test); and 4) test-retest validation, assessment of internal consistency (Cronbach’s alpha) and reproducibility over time (intraclass correlation coefficient and Cohen’s kappa coefficient).

Results: PERSYVE is divided into six sections according to results obtained from the literature review: (1) drug adherence, (2) perceived symptoms and how they affect quality of life (five-point Likert scale), (3) communication with health professionals, (4) perception of symptoms as adverse reactions, (5) influence on therapy compliance, and (6) adoption of non-pharmacological methods for blood pressure control. Content and face validation of the questionnaire led to some vocabulary changes and the introduction of section 2.1. Field-testing (n=26) revealed high comprehensibility of the questions. The Cronbach's alpha, calculated for section 2 (five-point Likert scale) was 0.850. PERSYVE was reproducible (n=167): kappa values presented fair to substantial reproducibility and, in section 2, ICC values resulted in good to excellent reproducibility.

Conclusion: Results showed that PERSYVE is a well-structured, objective, patient-friendly, valid and reliable questionnaire. PERSYVE can be a very useful instrument in hypertensive patients’ monitoring and in the screening of adverse effects.


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1. Whitworth JA; World Health Organization, International Society of Hypertension Writing Group.. 2003 World Health Organization (WHO)/International Society of Hypertension (ISH) statement on management of hypertension. J Hypertens. 2003;21(11):1983-1992. doi: 10.1097/01.hjh.0000084751.37215.d2

2. Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ. Selected major risk factors and global and regional burden of disease. Lancet. 2002;360(9343):1347-1360. doi: 10.1016/S0140-6736(02)11403-6

3. Poon IO. Effects of antihypertensive drug treatment on the risk of dementia and cognitive impairment. Pharmacotherapy. 2008;28(3):366-375. doi: 10.1592/phco.28.3.366

4. Cheung BM, Wong YL, Lau CP. Queen Mary Utilization of Antihypertensive Drugs Study: side-effects of antihypertensive drugs. J Clin Pharm Ther. 2005;30(4):391-399. doi: 10.1111/j.1365-2710.2005.00662.x

5. Ross SD, Akhras KS, Zhang S, Rozinsky M, Nalysnyk L. Discontinuation of antihypertensive drugs due to adverse events: a systematic review and meta-analysis. Pharmacotherapy. 2001;21(8):940-953.

6. Dusing R, Weisser B, Mengden T, Vetter H. Changes in antihypertensive therapy--the role of adverse effects and compliance. Blood Press. 1998;7(5-6):313-315.

7. Dragomir A, Côté R, Roy L, Blais L, Lalonde L, Bérard A, Perreault S. Impact of adherence to antihypertensive agents on clinical outcomes and hospitalization costs. Med Care. 2010;48(5):418-425. doi: 10.1097/MLR.0b013e3181d567bd

8. Fodor GJ, Kotrec M, Bacskai K, Dorner T, Lietava J, Sonkodi S, Rieder A, Turton P. Is interview a reliable method to verify the compliance with antihypertensive therapy? An international central-European study. J Hypertens. 2005;23(6):1261-1266.

9. Piñeiro F, Gil V, Donis M, Orozco D, Pastor R, Merino J. [The validity of 6 indirect methods for assessing drug treatment compliance in arterial hypertension]. Aten Primaria. 1997;19(7):372-376.

10. Simpson SH, Johnson JA, Farris KB, Tsuyuki RT. Development and validation of a survey to assess barriers to drug use in patients with chronic heart failure. Pharmacotherapy. 2002;22(9):1163-1172.

11. Gascon Canovas JJ, Saturno Hernandez PJ, Sanchez Sanchez JA. [Usefulness of patients' reports in monitoring rational use of medicines]. Aten Primaria. 2001;27(6):395-402.

12. Jarernsiripornkul N, Kakaew W, Loalukkana W, Krska J. Adverse drug reaction monitoring: comparing doctor and patient reporting for new drugs. Pharmacoepidemiol Drug Saf. 2009;18(3):240-245. doi: 10.1002/pds.1708

13. Jarernsiripornkul N, Krska J, Capps PA, Richards RM, Lee A. Patient reporting of potential adverse drug reactions: a methodological study. Br J Clin Pharmacol. 2002;53(3):318-325.

14. Baez Saldana AR, Chapela Mendoza R, Herrera Kiengelher L, Ortiz Siordia R, Salas Hernandez J. [Development of a questionnaire to measure asthmatic patients' knowledge of their disease]. Arch Bronconeumol. 2007;43(5):248-255.

15. Okun ML, Kravitz HM, Sowers MF, Moul DE, Buysse DJ, Hall M. Psychometric evaluation of the Insomnia Symptom Questionnaire: a self-report measure to identify chronic insomnia. J Clin Sleep Med. 2009;5(1):41-51.

16. Bengtsson M, Ohlsson B, Ulander K. Development and psychometric testing of the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS). BMC Gastroenterol. 2007;7:16. doi: 10.1186/1471-230X-7-16

17. Sackett DL, Haynes RB, Gibson ES, Hackett BC, Taylor DW, Roberts RS, Johnson AL. Randomised clinical trial of strategies for improving medication compliance in primary hypertension. Lancet. 1975;1(7918):1205-1207.

18. Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012

19. Alumran A, Hou XY, Hurst C. Validity and reliability of instruments designed to measure factors influencing the overuse of antibiotics. J Infect Public Health. 2012;5(3):221-232. doi: 10.1016/j.jiph.2012.03.003

20. Marx RG, Menezes A, Horovitz L, Jones EC, Warren RF. A comparison of two time intervals for test-retest reliability of health status instruments. J Clin Epidemiol. 2003;56(8):730-735.

21. dos Santos Pernas SI, Herdeiro MT, Lopez-Gonzalez E, da Cruz e Silva OA, Figueiras A. Attitudes of Portuguese health professionals toward adverse drug reaction reporting. Int J Clin Pharm. 2012;34(5):693-698. doi: 10.1007/s11096-012-9675-6

22. Cronbach LJ. Coefficient alpha and the internal structure of tests. Psychometrika. 1951;16(3):297-334.

23. Tavakol M, Dennick R. Making sense of Cronbach' alpha. Int J Med Educ. 2011;2:53-55. doi: 10.5116/ijme.4dfb.8dfd

24. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33(1):159-174.

25. World Health Organization. Adherence to long-term therapies: evidence fo action. Geneva: WHO;2003.

26. Stone DH. Design a questionnaire. BMJ. 1993;307(6914):1264-1266.

27. Basch E, Jia X, Heller G, Barz A, Sit L, Fruscione M, Appawu M, Iasonos A, Atkinson T, Goldfarb S, Culkin A, Kris MG, Schrag D. Adverse symptom event reporting by patients vs clinicians: relationships with clinical outcomes. J Natl Cancer Inst. 2009;101(23):1624-1632. doi: 10.1093/jnci/djp386

28. Blenkinsopp A, Wilkie P, Wang M, Routledge PA. Patient reporting of suspected adverse drug reactions: a review of published literature and international experience. Br J Clin Pharmacol. 2007;63(2):148-156. doi: 10.1111/j.1365-2125.2006.02746.x

29. Bengtsson M, Ohlsson B, Ulander K. Development and psychometric testing of the Visual Analogue Scale for Irritable Bowel Syndrome (VAS-IBS). BMC Gastroenterol. 2007;7:16. doi:10.1186/1471-230X-7-16

30. García Delgado P, Gastelurrutia Garralda MA, Baena Parejo MI, Fisac Lozano F, Martínez Martínez F. [Validation of a questionnaire to assess patient knowledge of their medicines]. Aten Primaria. 2009;41(12):661-668. doi: 10.1016/j.aprim.2009.03.011

31. Saldaña ARB, Mendoza RC, Kiengelher LH, Rebeca Ortiz Siordia, Hernández JS. Development of a Questionnaire to Measure Asthmatic Patients’ Knowledge of Their Disease. Arch Bronconeumol. 2007;43(5):248-255.

32. Simpson SH, Johnson JA, Farris KB, Tsuyuki RT. Development and validation of a survey to assess barriers to drug use in patients with chronic heart failure. Pharmacotherapy. 2002;22(9):1163-1172.

33. Bharmal M, Payne K, Atkinson M, Desrosiers M-P, Morisky D, Gemmen E. Validation of an abbreviated Treatment Satisfaction Questionnaire for Medication (TSQM-9) among patients on antihypertensive medications. Health Qual Life Outcomes. 2009;7:36. doi: 10.1186/1477-7525-7-36

34. Brown JB, Adams ME. Patients as Reliable Reporters of Medical Care Process: Recall of Ambulatory Encounter Events. Med Care. 1992;30(5):400-411.

35. Johnson T, Fendrich M. Modeling Sources of Self-report Bias in a Survey of Drug Use Epidemiology. Ann Epidemiol. 2005;15(5):381-389.
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