The psychological impact of Peyronie's disease: a retrospective analysis of 603 patients

Background: Peyronie’s disease (PD) impacts the penile albuginea, leading to deformity, pain, erectile dysfunction (ED), and an anxious-depressive state. Diagnosis of PD involves taking a detailed medical history; examining the penis by palpation; documenting any deformities; performing a dynamic Doppler ultrasound; and administering questionnaires to assess pain, erectile dysfunction (ED), and the patient’s psychological status. The aim of this study was to assess the symptoms of PD and their prevalence among patients in the active phase who were seen at our andrology clinic.
Methods: The inclusion criteria were: data must be available for patients diagnosed with active PD, including a comprehensive medical history, blood test results, penile examination information, photographic evidence of the deformity, color Doppler penile ultrasound, and completed questionnaires, including visual analog scale (VAS) for pain assessment, International Index of Erectile Function (IIEF) for assessing erectile function, and psychometric test. Exclusion criteria: Patients with PD who are in a stable phase or not having data requested for inclusion. 
Results: We detected penile curvature in 90.5%, penile pain in 54%; ED in 39.3%, significative anxiety in 89.0%, significative depression in 57.6%, and bother in 93.6%.
Conclusions: Our study revealed that a large number of patients with PD experience significant levels of anxiety and depression, with 38.3% of them experiencing severe anxiety. Psychotherapy should be included as part of the treatment plan for patients with PD to enhance their quality of life and adherence to treatment.

1. Ziegelmann MJ, Bajic P, Levine LA. Peyronie's disease: Contemporary evaluation and management. Int J Urol. 2020; 27:504-516. DOI: https://doi.org/10.1111/iju.14230

2. Dullea A, Efimenko I, Firdaus F, et al. Whole-genome sequencing identifies novel heterozygous mutation in ALMS1 in three men with both Peyronie's and Dupuytren's disease. Urology 2022; 166:76-78. DOI: https://doi.org/10.1016/j.urology.2022.02.023

3. Schwarzer U, Sommer F, Klotz T, et al. The prevalence of Peyronie's disease: results of a large survey. BJU Int. 2001; 88:727-730. DOI: https://doi.org/10.1046/j.1464-4096.2001.02436.x

4. La Pera G, Pescatori ES, Calabrese M, et al. SIMONA Study Group. Peyronie's disease: prevalence and association with cigarette smoking. A multicenter population-based study in men aged 50-69 years. Eur Urol. 2001; 40:525-530. DOI: https://doi.org/10.1159/000049830

5. Dibenedetti DB, Nguyen D, Zografos L, et al. A population-based study of Peyronie's disease: prevalence and treatment patterns in the United States. Adv Urol. 2011;2011:282503. DOI: https://doi.org/10.1155/2011/282503

6. Stuntz M, Perlaky A, des Vignes F, et al. The prevalence of Peyronie's disease in the United States: a population-based study. PLoS One 2016; 11:e0150157. DOI: https://doi.org/10.1371/journal.pone.0150157

7. Shiraishi K, Shimabukuro T, Matsuyama H. The prevalence of Peyronie's disease in Japan: a study in men undergoing maintenance hemodialysis and routine health checks. J Sex Med. 2012; 9:2716-2723. DOI: https://doi.org/10.1111/j.1743-6109.2012.02868.x

8. Wong A,Tsang SS, O RY, et al. Mp33-12 Prevalence of Peyronie’s disease and its psychosexual impact in the chinese population: A large cohort population-based cross-sectional study. J Urol 2020; 203:e499-e499. DOI: https://doi.org/10.1097/JU.0000000000000877.012

9. Devine CJ Jr, Somers KD, Ladaga LE. Peyronie's disease: pathophysiology. Prog Clin Biol Res. 1991; 370:355-358.

10. Devine CJ Jr, Somers KD, Jordan SG, et al. Proposal: trauma as the cause of the Peyronie's lesion. J Urol. 1997; 157:285-290. DOI: https://doi.org/10.1016/S0022-5347(01)65361-8

11. Jarow JP, Lowe FC. Penile trauma: an etiologic factor in Peyronie's disease and erectile dysfunction. J Urol. 1997; 158:1388-1390. DOI: https://doi.org/10.1016/S0022-5347(01)64222-8

12. Yousif A, Natale C, Hellstrom WJG. Conservative therapy for Peyronie's disease: a contemporary review of the literature. Curr Urol Rep. 2021; 22:6. DOI: https://doi.org/10.1007/s11934-020-01024-8

13. Natale C, McLellan DM, Yousif A, et al. Review of intralesional collagenase Clostridium histolyticum injection therapy and related combination therapies in the treatment of Peyronie's disease (an update). Sex Med Rev. 2021; 9:340-349. DOI: https://doi.org/10.1016/j.sxmr.2020.01.005

14. Nguyen HMT, Anaissie J, DeLay KJ, et al. Safety and efficacy of collagenase Clostridium histolyticum in the treatment of acute-phase Peyronie's disease. J Sex Med. 2017; 14:1220-1225. DOI: https://doi.org/10.1016/j.jsxm.2017.08.008

15. Levine LA, Larsen S. Diagnosis and management of Peyronie Disease. In: Campbell-Walsh Urology. 11th Ed., Wein AJ, Kavoussi LR, Partin AW, Peters CA, Eds. Elsevier Saunders: Philadelphia, 2015. Volume 1 (Chapter 31); pp 722-748.

16. Hauck EW, Diemer T, Schmelz HU, et al. A critical analysis of nonsurgical treatment of Peyronie's disease. Eur Urol. 2006; 49:987-997. DOI: https://doi.org/10.1016/j.eururo.2006.02.059

17. Levine LA, Estrada CR. Intralesional verapamil for the treatment of Peyronie's disease: a review. Int J Impot Res. 2002; 14:324-328. DOI: https://doi.org/10.1038/sj.ijir.3900917

18. Krieger JR, Rizk PJ, Kohn TP, et al. Shockwave therapy in the treatment of Peyronie's disease. Sex Med Rev. 2019; 7:499-507. DOI: https://doi.org/10.1016/j.sxmr.2019.02.001

19. Levine LA, Burnett AL. Standard operating procedures for Peyronie's disease. J Sex Med. 2013; 10:230-244. DOI: https://doi.org/10.1111/j.1743-6109.2012.03003.x

20. Martínez-Salamanca JI, Egui A, Moncada I, et al. Acute phase Peyronie's disease management with traction device: a nonrandomized prospective controlled trial with ultrasound correlation. J Sex Med. 2014; 11:506-515. DOI: https://doi.org/10.1111/jsm.12400

21. Raheem AA, Garaffa G, Raheem TA, et al. The role of vacuum pump therapy to mechanically straighten the penis in Peyronie's disease. BJU Int. 2010; 106:1178-1180. DOI: https://doi.org/10.1111/j.1464-410X.2010.09365.x

22. Sikka SC, Hellstrom WJ. Role of oxidative stress and antioxidants in Peyronie's disease. Int J Impot Res. 2002; 14:353-360. DOI: https://doi.org/10.1038/sj.ijir.3900880

23. Gonzalez-Cadavid NF, Magee TR, Ferrini M, et al. Gene expression in Peyronie's disease. Int J Impot Res. 2002; 14:361-374. DOI: https://doi.org/10.1038/sj.ijir.3900873

24. Bivalacqua TJ, Champion HC, Hellstrom WJ. Implications of nitric oxide synthase isoforms in the pathophysiology of Peyronie's disease. Int J Impot Res. 2002; 14:345-352. DOI: https://doi.org/10.1038/sj.ijir.3900872

25. Davila HH, Magee TR, Vernet D, et al. Gene transfer of inducible nitric oxide synthase complementary DNA regresses the fibrotic plaque in an animal model of Peyronie's disease. Biol Reprod. 2004; 71:1568-1577. DOI: https://doi.org/10.1095/biolreprod.104.030833

26. Paulis G, Brancato T. Inflammatory mechanisms and oxidative stress in Peyronie's disease: therapeutic "rationale" and related emerging treatment strategies. Inflamm Allergy Drug Targets 2012; 11:48-57. DOI: https://doi.org/10.2174/187152812798889321

27. El-Sakka AI, Salabas E, Dinçer M, et al. The pathophysiology of Peyronie's disease. Arab J Urol. 2013; 11:272-277. DOI: https://doi.org/10.1016/j.aju.2013.06.006

28. Paulis G, Romano G, Paulis L, et al. Recent pathophysiological aspects of Peyronie's disease: role of free radicals, rationale, and therapeutic implications for antioxidant treatment-Literature review. Adv Urol. 2017; 2017:4653512. DOI: https://doi.org/10.1155/2017/4653512

29. Paulis G, De Giorgio G, Paulis L. Role of oxidative stress in Peyronie's Disease: biochemical evidence and experiences of treatment with antioxidants. Int J Mol Sci. 2022; 23:15969. DOI: https://doi.org/10.3390/ijms232415969

30. Brant WO, Dean RC, Lue TF. Treatment of Peyronie's disease with oral pentoxifylline. Nat Clin Pract Urol. 2006; 3:111-115;quiz 116. DOI: https://doi.org/10.1038/ncpuro0409

31. Paulis G, Barletta D, Turchi P, et al. Efficacy and safety evaluation of pentoxifylline associated with other antioxidants in medical treatment of Peyronie's disease: a case-control study. Res Rep Urol. 2015; 8:1-10. DOI: https://doi.org/10.2147/RRU.S97194

32. Kendirci M, Hellstrom WJ. Critical analysis of surgery for Peyronie's disease. Curr Opin Urol. 2004; 14:381-388. DOI: https://doi.org/10.1097/00042307-200411000-00015

33. Kadioglu A, Akman T, Sanli O, et al. Surgical treatment of Peyronie's disease: a critical analysis. Eur Urol. 2006; 50:235-248. DOI: https://doi.org/10.1016/j.eururo.2006.04.030

34. Hatzimouratidis K, Eardley I, Giuliano F, et al. EAU guidelines on penile curvature. Eur Urol. 2012; 62:543-552. DOI: https://doi.org/10.1016/j.eururo.2012.05.040

35. Garaffa G, Trost LW, Serefoglu EC, et al. Understanding the course of Peyronie's disease. Int J Clin Pract. 2013; 67:781-788. DOI: https://doi.org/10.1111/ijcp.12129

36. Nehra A, Alterowitz R, Culkin DJ, et al. Peyronie's Disease: AUA Guideline. J Urol. 2015; 194:745-753. DOI: https://doi.org/10.1016/j.juro.2015.05.098

37. Chung E, Ralph D, Kagioglu A, et al. Evidence-based management guidelines on Peyronie’s disease. J Sex Med. 2016; 13:905-923. DOI: https://doi.org/10.1016/j.jsxm.2016.04.062

38. Osmonov D, Ragheb A, Ward S, et al. ESSM position statement on surgical treatment of Peyronie's disease. Sex Med. 2022;10:100459. DOI: https://doi.org/10.1016/j.esxm.2021.100459

39. Weidner W, Schroeder-Printzen I, Weiske WH, et al. Sexual dysfunction in Peyronie's disease: an analysis of 222 patients without previous local plaque therapy. J Urol. 1997; 157:325-328. DOI: https://doi.org/10.1016/S0022-5347(01)65370-9

40. Pryor JP, Ralph DJ. Clinical presentations of Peyronie's disease. Int J Impot Res. 2002; 14:414-417. DOI: https://doi.org/10.1038/sj.ijir.3900877

41. Kadioglu A, Sanli O, Akman T, et al. Factors affecting the degree of penile deformity in Peyronie disease: an analysis of 1001 patients. J Androl. 2011; 32:502-508. DOI: https://doi.org/10.2164/jandrol.110.011031

42. Paulis G, De Giorgio G, Paulis A. Clinical presentation of Peyronie's disease: a retrospective study of 564 cases. Diagnostics (Basel) 2024;14:1125. DOI: https://doi.org/10.3390/diagnostics14111125

43. Taylor FL, Levine LA. Peyronie's disease. Urol Clin North Am. 2007; 34:517-534, vi. DOI: https://doi.org/10.1016/j.ucl.2007.08.017

44. Rosen R, Catania J, Lue T, et al. Impact of Peyronie's disease on sexual and psychosocial functioning: qualitative findings in patients and controls. J Sex Med. 2008; 5:1977-1984. DOI: https://doi.org/10.1111/j.1743-6109.2008.00883.x

45. Smith JF, Walsh TJ, Conti SL, et al. Risk factors for emotional and relationship problems in Peyronie's disease. J Sex Med. 2008; 5:2179-2184. DOI: https://doi.org/10.1111/j.1743-6109.2008.00949.x

46. Nelson CJ, Diblasio C, Kendirci M, et al. The chronology of depression and distress in men with Peyronie's disease. J Sex Med. 2008; 5:1985-1990. DOI: https://doi.org/10.1111/j.1743-6109.2008.00895.x

47. Nelson CJ, Mulhall JP. Psychological impact of Peyronie's disease: a review. J Sex Med. 2013; 10:653-660. DOI: https://doi.org/10.1111/j.1743-6109.2012.02999.x

48. Levine LA. The clinical and psychosocial impact of Peyronie's disease. Am J Manag Care 2013; 19:S55-61.

49. Hartzell R. Psychosexual symptoms and treatment of Peyronie's disease within a collaborative care model. Sex Med. 2014; 2:168-177. DOI: https://doi.org/10.1002/sm2.45

50. Terrier JE, Nelson CJ. Psychological aspects of Peyronie's disease. Transl Androl Urol. 2016; 5: 290-295. DOI: https://doi.org/10.21037/tau.2016.05.14

51. Goldstein I, Hartzell R, Shabsigh R. The impact of Peyronie's disease on the patient: gaps in our current understanding. J Sex Marital Ther. 2016; 42:178-190. DOI: https://doi.org/10.1080/0092623X.2014.985351

52. Paulis G, Romano G, Paulis A. Prevalence, psychological impact, and risk factors of erectile dysfunction in patients with Peyronie's disease: a retrospective analysis of 309 cases. Res Rep Urol. 2016; 8:95-103. DOI: https://doi.org/10.2147/RRU.S109319

53. Salter CA, Nascimento B, Terrier JE, et al. Evaluating the impact of penile girth discrepancy on patient bother in men with Peyronie's disease: an observational Study. J Sex Med. 2020; 17:1560-1565. DOI: https://doi.org/10.1016/j.jsxm.2020.05.003

54. Kuja-Halkola R, Henningsohn L, D'Onofrio BM, et al. Mental disorders in Peyronie's disease: A Swedish cohort study of 3.5 million men. J Urol. 2021; 205:864-870. DOI: https://doi.org/10.1097/JU.0000000000001426

55. Punjani N, Nascimento B, Salter C, et al. Predictors of depression in men with Peyronie's disease seeking evaluation. J Sex Med. 2021;18:783-788. DOI: https://doi.org/10.1016/j.jsxm.2021.02.002

56. Low P, Wang L, Li KD, et al. Thematic analysis of the psycho-sexual symptoms in patients with Peyronie's disease present on online forums. Int J Impot Res. 2023; 35:533-538. DOI: https://doi.org/10.1038/s41443-022-00589-x

57. Kraglund R, Durukan E, Giraldi A, et al. The association between Peyronie's disease and depression: a scoping review. Sex Med Rev. 2024; 12:221-229. DOI: https://doi.org/10.1093/sxmrev/qead045

58. Lindhardt-Mejlholm SL, Mortensen KS, Andersen IT, et al. Peyronie's disease and risk of depression. A nationwide 25-year cohort study. J Sex Med. 2025; 22:1640-1646. DOI: https://doi.org/10.1093/jsxmed/qdaf168

59. Kelâmi A. Autophotography in evaluation of functional penile disorders. Urology 1983; 21:628-629. DOI: https://doi.org/10.1016/0090-4295(83)90210-8

60. Levine LA, Coogan CL. Penile vascular assessment using color duplex sonography in men with Peyronie's disease. J Urol. 1996;155:1270-1273. DOI: https://doi.org/10.1016/S0022-5347(01)66239-6

61. Kahl C, Cleland JA. Visual analogue scale, numeric pain rating scale and the McGill pain Questionnaire: An overview of psychometric properties. Phys Ther Rev. 2005; 10:123-128. DOI: https://doi.org/10.1179/108331905X55776

62. Rosen RC, Riley A, Wagner G, et al. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997; 49:822-830. DOI: https://doi.org/10.1016/S0090-4295(97)00238-0

63. Spitzer RL, Kroenke K, Williams JB, et al. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006; 166:1092-1097. DOI: https://doi.org/10.1001/archinte.166.10.1092

64. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med. 2001; 16:606-613. DOI: https://doi.org/10.1046/j.1525-1497.2001.016009606.x

65. Hellstrom WJ, Feldman R, Rosen RC, et al. Bother and distress associated with Peyronie's disease: validation of the Peyronie's disease questionnaire. J Urol. 2013; 190:627-634. DOI: https://doi.org/10.1016/j.juro.2013.01.090

66. Coyne KS, Currie BM, Thompson CL, et al. The test-retest reliability of the Peyronie's disease questionnaire. J Sex Med. 2015; 12:543-548. DOI: https://doi.org/10.1111/jsm.12769

67. Cilio S, Fallara G, Capogrosso P, et al. The symptomatic burden of Peyronie's disease at presentation according to patient age: A critical analysis of the Peyronie's disease questionnaire (PDQ) domains. Andrology 2023; 11:501-517. DOI: https://doi.org/10.1111/andr.13352

68. Traunero F, Di Grazia M, Ongaro L, et al. Validation of the Italian version of the Peyronie's Disease Questionnaire (PDQ). Int J Impot Res. 2024; 36:588-591. DOI: https://doi.org/10.1038/s41443-023-00792-4

69. Hellmann F, Verdi M, Schlemper BR Jr, et al. 50th anniversary of the Declaration of Helsinki: the double standard was introduced. Arch Med Res. 2014; 45:600-601. DOI: https://doi.org/10.1016/j.arcmed.2014.10.005

70. Zheng DC, Bao JW, Guo JH, et al. Effects of patients' understanding and choice of surgical types on postoperative outcomes of Peyronie's disease: a single-center retrospective study of 108 patients. Asian J Androl. 2021; 23:484-489. DOI: https://doi.org/10.4103/aja.aja_32_21

71. Lindsay MB, Schain DM, Grambsch P, et al. The incidence of Peyronie's disease in Rochester, Minnesota, 1950 through 1984. J Urol. 1991; 146:1007-1009. DOI: https://doi.org/10.1016/S0022-5347(17)37988-0

72. Cakan M, Akman T, Oktar T, et al. The clinical characteristics of Peyronie's patients with notching deformity. J Sex Med. 2007; 4:1174-1178. DOI: https://doi.org/10.1111/j.1743-6109.2006.00258.x

73. Paulis G, Cavallini G, Barletta D, et al. Clinical and epidemiological characteristics of young patients with Peyronie's disease: a retrospective study. Res Rep Urol. 2015; 7:107-111. DOI: https://doi.org/10.2147/RRU.S85708

74. Margolin EJ, Pagano MJ, Aisen CM, et al. Beyond curvature: prevalence and characteristics of penile volume-loss deformities in men with Peyronie’s disease. Sex Med. 2018; 6:309-315. DOI: https://doi.org/10.1016/j.esxm.2018.07.003

75. Kadioglu A, Tefekli A, Erol B, et al. A retrospective review of 307 men with Peyronie's disease. J Urol. 2002; 168:1075-1079. DOI: https://doi.org/10.1016/S0022-5347(05)64578-8

76. Bajic P, Wiggins AB, Ziegelmann MJ, et al. Characteristics of men with Peyronie's Disease and collagenase Clostridium histolyticum treatment failure: predictors of surgical intervention and outcomes. J Sex Med. 2020; 17:1005-1011. DOI: https://doi.org/10.1016/j.jsxm.2020.02.002

77. Seveso M, Melegari S, De Francesco O, et al. Surgical correction of Peyronie's disease via tunica albuginea plication: long-term follow-up. Andrology 2018;6:47-52. DOI: https://doi.org/10.1111/andr.12431

78. Liguori G, Salonia A, Garaffa G, et al. Objective measurements of the penile angulation are significantly different than self-estimated magnitude among patients with penile curvature. Int Braz J Urol. 2018;44:555-562. DOI: https://doi.org/10.1590/s1677-5538.ibju.2017.0418

79. Levine LA, Latchamsetty KC. Treatment of erectile dysfunction in patients with Peyronie's disease using sildenafil citrate. Int J Impot Res. 2002; 14:478-482. DOI: https://doi.org/10.1038/sj.ijir.3900912

80. Levine LA. Peyronie’s disease and erectile dysfunction: Current understanding and future direction. Indian J Urol. 2006; 22:246-250. DOI: https://doi.org/10.4103/0970-1591.27633

81. Deveci S, Palese M, Parker M, et al. Erectile function profiles in men with Peyronie's disease. J Urol. 2006; 175:1807-1811;discussion 1811. DOI: https://doi.org/10.1016/S0022-5347(05)01018-9

82. Liu M, Wang D, Fang J, et al. Validation of the generalized anxiety disorder-7 in patients with COPD: a cross-sectional study. BMC Psychiatry 2023; 23:593. DOI: https://doi.org/10.1186/s12888-023-05072-5

83. Liu M, Yang X, Wang D, et al. Development and validation of a screening tool for generalized anxiety and major depressive disorder in patients with chronic obstructive pulmonary disease. Lung 2024;203:6. DOI: https://doi.org/10.1007/s00408-024-00767-2

84. Hitchon CA, Zhang L, Peschken CA, et al. Validity and reliability of screening measures for depression and anxiety disorders in rheumatoid arthritis. Arthritis Care Res. (Hoboken) 2020; 72:1130-1139. DOI: https://doi.org/10.1002/acr.24011

85. Pettersson S, Lövgren M, Eriksson LE, et al. An exploration of patient-reported symptoms in systemic lupus erythematosus and the relationship to health-related quality of life. Scand J Rheumatol. 2012;41:383-390. DOI: https://doi.org/10.3109/03009742.2012.677857

86. Callhoff J, Berger K, Albrecht K, et al. Depression, anxiety and cognitive function in persons with inflammatory rheumatic diseases: cross-sectional results from the German National Cohort (NAKO). RMD Open 2024; 10:e004808. DOI: https://doi.org/10.1136/rmdopen-2024-004808

87. Seaton N, Wileman V, Norton C, et al. The relationships between depression, inflammation and self-reported disease activity in IBD and their impact on healthcare usage. BMC Gastroenterol. 2025; 25:140. DOI: https://doi.org/10.1186/s12876-025-03691-8

88. Paulis G, Paulis A, Romano G, et al. Rationale of combination therapy with antioxidants in medical management of Peyronie's disease: results of clinical application. Res Rep Urol. 2017; 9:129-139. DOI: https://doi.org/10.2147/RRU.S141748

89. Paulis G, Paulis A. Calcification in Peyronie's disease: Its role and clinical influence on the various symptoms and signs of the disease, including psychological impact. Our study of 551 patients. Arch Ital Urol Androl. 2023; 95:11549. DOI: https://doi.org/10.4081/aiua.2023.11549

90. Paulis G, Paulis A, De Giorgio G, et al. Measurement of oxidative stress index in 102 patients with Peyronie's disease. Metabolites 2025;15:503. DOI: https://doi.org/10.3390/metabo15080503

91. Levine L, Rybak J, Corder C, et al. Peyronie's disease plaque calcification--prevalence, time to identification, and development of a new grading classification. J Sex Med. 2013; 10:3121-3128. DOI: https://doi.org/10.1111/jsm.12334

92. Goldstein I, Knoll LD, Lipshultz LI, et al. Changes in the effects of Peyronie's disease after treatment with collagenase Clostridium histolyticum: male patients and their female partners. Sex Med. 2017;5:e124-e130. DOI: https://doi.org/10.1016/j.esxm.2017.02.001

93. Serefoglu EC, Smith TM, Kaufman GJ, et al. Factors associated with erectile dysfunction and the Peyronie's disease questionnaire in patients with Peyronie disease. Urology 2017; 107:155-160. DOI: https://doi.org/10.1016/j.urology.2017.05.029

94. Burri A, Porst H. The relationship between penile deformity, age, psychological bother, and erectile dysfunction in a sample of men with Peyronie's Disease (PD). Int J Impot Res. 2018; 30:171-178. DOI: https://doi.org/10.1038/s41443-018-0029-3

95. Sun H, Saeedi P, Karuranga S, et al. IDF Diabetes Atlas: Global, regional and country-level diabetes prevalence estimates for 2021 and projections for 2045. Diabetes Res Clin Pract. 2022;183:109119. DOI: https://doi.org/10.1016/j.diabres.2021.109119