ORIGINAL RESEARCH—OUTCOMES ASSESSMENT: Validation of the Erection Hardness Score
John P. Mulhall MD,
Irwin Goldstein MD,
Andrew G. Bushmakin MS,
Joseph C. Cappelleri PhD, MPH,
Kyle Hvidsten MPH,
Corresponding Author
John P. Mulhall MD
Weill Medical College of Cornell University and Memorial Sloan Kettering Cancer Center, New York, NY, USA;
John P. Mulhall, MD, Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital & Memorial Sloane Kettering Cancer Center, 525 East 68th Street, New York, NY 10021, USA. Tel: 212-746-5653; Fax: 212-746-0403; E-mail: [email protected]Search for more papers by this authorIrwin Goldstein MD
Sexual Medicine, Alvarado Hospital, San Diego, CA, USA;
Search for more papers by this authorAndrew G. Bushmakin MS
Pfizer Inc, Global Research & Development, Groton, CT, USA;
Search for more papers by this authorJoseph C. Cappelleri PhD, MPH
Pfizer Inc, Global Research & Development, Groton, CT, USA;
Search for more papers by this authorJohn P. Mulhall MD,
Irwin Goldstein MD,
Andrew G. Bushmakin MS,
Joseph C. Cappelleri PhD, MPH,
Kyle Hvidsten MPH,
Corresponding Author
John P. Mulhall MD
Weill Medical College of Cornell University and Memorial Sloan Kettering Cancer Center, New York, NY, USA;
John P. Mulhall, MD, Department of Urology, Weill Medical College of Cornell University, New York Presbyterian Hospital & Memorial Sloane Kettering Cancer Center, 525 East 68th Street, New York, NY 10021, USA. Tel: 212-746-5653; Fax: 212-746-0403; E-mail: [email protected]Search for more papers by this authorIrwin Goldstein MD
Sexual Medicine, Alvarado Hospital, San Diego, CA, USA;
Search for more papers by this authorAndrew G. Bushmakin MS
Pfizer Inc, Global Research & Development, Groton, CT, USA;
Search for more papers by this authorJoseph C. Cappelleri PhD, MPH
Pfizer Inc, Global Research & Development, Groton, CT, USA;
Search for more papers by this authorABSTRACT
Introduction. Erection hardness is a fundamental component of erectile function, and is a very specific and easily monitored outcome. The Erection Hardness Score (EHS) is a single-item, patient-reported outcome (PRO) for scoring erection hardness.
Aims. The aim of this article is to report the psychometric validation of the EHS.
Methods. The dataset (N = 307) was from a multinational sildenafil trial (efficacy in the treatment of erectile dysfunction [ED]) with a 2-week screening phase, a 6-week double-blind, placebo-controlled treatment phase, and a 6-week open-label extension.
Main Outcome Measures. Test–retest reliability (intraclass correlation coefficient), quality and distribution of responses, known-groups validity (ability to differentiate between ED severity groups defined by the International Index of Erectile Function [IIEF] questionnaire), convergent validity (Pearson correlation coefficients with domain scores of the IIEF and the Quality of Erection Questionnaire [QEQ]), treatment responsiveness, and clinically important difference.
Results. The EHS demonstrated good test–retest reliability, acceptable quality and distribution of responses, known-groups validity against the IIEF (including clear differentiation between normal and impaired erectile function), moderate-to-strong convergent validity against the prespecified domains of the IIEF and QEQ, and high treatment responsiveness.
Conclusion. The EHS has desirable measurement properties, including being highly responsive to treatment. This one-item PRO is robust and easy to use for evaluating erection hardness. Psychometric analysis supports the use of the EHS as a simple, reliable, and valid tool for the assessment of erection hardness in clinical trials research. Mulhall JP, Goldstein I, Bushmakin AG, Cappelleri JC, and Hvidsten K. Validation of the Erection Hardness Score. J Sex Med 2007;4:1626–1634.
References
- 1 Carson C, Giuliano F, Goldstein I, Hatzichristou D, Hellstrom W, Lue T, Montorsi F, Munarriz R, Nehra A, Porst H, Rosen R. The “effectiveness” scale–therapeutic outcome of pharmacologic therapies for ED: An international consensus panel report. Int J Impot Res 2004; 16: 207–13.
- 2 Udelson D, Nehra A, Hatzichristou D, Azadzoi K, Moreland R, Krane J, Saenz de Tejada I, Goldstein I. Engineering analysis of penile hemodynamic and structural-dynamic relationships: Part I–Clinical implications of penile tissue mechanical properties. Int J Impot Res 1998; 10: 15–24.
- 3 Udelson D, Nehra A, Hatzichristou D, Azadzoi K, Moreland R, Krane R, Saenz de Tejada I, Goldstein I. Engineering analysis of penile hemodynamic and structural-dynamic relationships: Part III–Clinical considerations of penile hemodynamic and rigidity erectile responses. Int J Impot Res 1998; 10: 89–99.
- 4 Udelson D, Nehra A, Hatzichristou D, Azadzoi K, Moreland R, Krane R, Saenz de Tejada I, Goldstein I. Engineering analysis of penile hemodynamic and structural-dynamic relationships: Part II–Clinical implications of penile buckling. Int J Impot Res 1998; 10: 25–35.
- 5 Nehra A, Azadzoi K, Moreland R, Pabby A, Siroky M, Krane R, Goldstein I, Udelson D. Cavernosal expandability is an erectile tissue mechanical property which predicts trabecular histology in an animal model of vasculogenic erectile dysfunction. J Urol 1998; 159: 2229–36.
- 6 Luo H, Goldstein I, Udelson D. A three-dimensional theoretical model of the relationship between cavernosal expandability and percent cavernosal smooth muscle. J Sex Med 2007; 4: 644–5; Discussion 651–5.
- 7 Allen RP, Smolev JK, Engel RM, BrendlerCB. Comparison of RigiScan and formal nocturnal penile tumescence testing in the evaluation of erectile rigidity. J Urol 1993; 149: 1265–8.
- 8 Goldstein I, Auerbach S, Padma-Nathan H, Rajfer J, Fitch W, Schmitt L. Axial penile rigidity as primary efficacy outcome during multi-institutional in-office dose titration clinical trials with alprostadil alfadex in patients with erectile dysfunction. Alprostadil Alfadex Study Group. Int J Impot Res 2000; 12: 205–11.
- 9 Karacan I, Moore C, Sahmay S. Measurement of pressure necessary for vaginal penetration. Sleep Res 1985; 14: 269A.
- 10 Lavoisier P, Courtois F, Proulx J, Durand L, De Carufel F. Validation of a non-invasive device to measure intracavernous pressure as an index of penile rigidity. Br J Urol 1990; 65: 624–8.
- 11 Licht MR, Lewis RW, Wollan PC, Harris CD. Comparison of RigiScan and sleep laboratory nocturnal penile tumescence in the diagnosis of organic impotence. J Urol 1995; 154: 1740–3.
- 12 Nofzinger E, Fasiczka A, Thase M, Reynolds C, Frank E, Jennings J, Garamoni G, Matzzie J, Kupfer D. Are buckling force measurements reliable in nocturnal penile tumescence studies? Sleep 1993; 16: 156–62.
- 13 Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PA. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 1998; 338: 1397–404.
- 14 Boolell M, Gepi-Attee S, Gingell JC, Allen MJ. Sildenafil, a novel effective oral therapy for male erectile dysfunction. Br J Urol 1996; 78: 257–61.
- 15 FDA. Guidance for Industry: Patient-reported outcome measures: Use in medical product development to support labeling claims. February 2006.
- 16 Fairclough DL. Patient reported outcomes as endpoints in medical research. Stat Methods Med Res 2004; 13: 115–38.
- 17 Guyatt GH, Jaeschke R. Measurements in clinical trials: Choosing the appropriate approach. In: B Spilker, ed. Quality of Life Assessments in Clinical Trials. Raven Press, Ltd.: New York, NY; 1990: 37–46.
- 18 DeVellis RF. Scale Development: Theory and Applications. Sage Publications: Newbury Park, CA; 1991.
- 19
McIver JP,
Carmines EG.
Unidimensional Scaling. Sage Publications: Newbury Park, CA; 1981.
10.4135/9781412986441 Google Scholar
- 20 SpectorPE. Summated Rating Scale Construction: An Introduction. Sage Publications: Newbury Park, CA; 1992.
- 21 Revicki DA, Osoba D, Fairclough D, Barofsky I, Berzon R, Leidy NK, Rothman M. Recommendations on health-related quality of life research to support labeling and promotional claims in the United States. Qual Life Res 2000; 9: 887–900.
- 22 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: 209–38.
- 23 Depko A, Kadioglu A, Grohmann W, Levinson I, Carlsson M, Collins S. Erection hardness and quality correlate with erectile function, emotional well-being, and treatment satisfaction: double-blind, placebo-controlled multinational trial of Viagra® (sildenafil citrate). J Sex Med 2007; 4(suppl 2): 134.
- 24
SingerJ.
Using SAS PROC MIXED to fix multilevel models, hierarchical models, and individual growth models.
J Educ Behav Stat
1998; 24: 323–55.
10.3102/10769986023004323 Google Scholar
- 25 Fleiss J. The Design and Analysis of Clinical Experiments. John Wiley & Sons Inc.: New York, NY; 1986: 49–51.
- 26 Streiner D, Norman G. Health Measurement Scales: A Practical Guide to Their Development and Use. 3rd edition. Oxford University Press: New York, NY; 1989.
- 27 Porst H, Gilbert C, Collins S, Huang X, Symonds T, Stecher V, Hvidsten K. Development and validation of the Quality of Erection Questionnaire. J Sex Med 2007; 4: 372–81.
- 28 Lowy M, Collins S, Bloch MT, Gillman M, Lording DW, Sutherland P, Wang H, Stecher V and the QEQ Study Group. Quality of erection questionnaire correlates: Change in erection quality with erectile function, hardness, and psychosocial measures in men treated with sildenafil for erectile dysfunction. J Sex Med 2007; 4: 83–92.
- 29 Cappelleri JC, Rosen RC, Smith MD, Mishra A, Osterloh IH. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology 1999; 54: 346–51.
- 30 Cappelleri JC, Siegel RL, Osterloh IH, Rosen RC. Relationship between patient self-assessment of erectile function and the erectile function domain of the international index of erectile function. Urology 2000; 56: 477–81.
- 31 Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd edition. Lawrence Erlbaum Associates: Hillsdale, NJ; 1988: 19–74.
- 32 Mulhall J, Althof S, Brock G, Goldstein I, Jünemann K-P, Kirby M. Erectile dysfunction: Monitoring response to treatment in clinical practice—recommendations of an international consensus panel. J Sex Med 2007; 4: 448–64.
- 33 Mulhall J, Land S, Parker M, Waters WB, Flanigan RC. The use of an erectogenic pharmacotherapy regimen following radical prostatectomy improves recovery of spontaneous erectile function. J Sex Med 2005; 2: 532–40; discussion 540–542.
- 34 Mulhall JP, Guhring P, Parker M, Hopps C. Assessment of the impact of sildenafil citrate on lower urinary tract symptoms in men with erectile dysfunction. J Sex Med 2006; 3: 662–7.
- 35 Mulhall J, Anderson M, Parker M. A surgical algorithm for men with combined Peyronie's disease and erectile dysfunction: Functional and satisfaction outcomes. J Sex Med 2005; 2: 132–8.
- 36 Mallis D, Moisidis K, Kirana PS, Papaharitou S, Simos G, Hatzichristou D. Moderate and severe erectile dysfunction equally affects life satisfaction. J Sex Med 2006; 3: 442–9.
- 37 Shamloul R, Ghanem H, Fahmy I, El-Meleigy A, Ashoor S, Elnashaar A, Kamel I. Testosterone therapy can enhance erectile function response to sildenafil in patients with PADAM: A pilot study. J Sex Med 2005; 2: 559–64.
- 38 Titta M, Tavolini IM, Moro FD, Cisternino A, Bassi P. Sexual counseling improved erectile rehabilitation after non-nerve-sparing radical retropubic prostatectomy or cystectomy–results of a randomized prospective study. J Sex Med 2006; 3: 267–73.
- 39 Althof SE, O'Leary MP, Cappelleri JC, Hvidsten K, Stecher VJ, Glina S, King R, Siegel RL. Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial. J Sex Med 2006; 3: 521–9.
- 40 Cappelleri JC, Bell SS, Althof SE, Siegel RS, Stecher VJ. Comparison between sildenafil-treated subjects with erectile dysfunction and control subjects on the Self-Esteem and Relationship Questionnaire. J Sex Med 2006; 3: 274–82.
- 41 Tolra JR, Campana JM, Ciutat LF, Miranda EF. Prospective, randomized, open-label, fixed-dose, crossover study to establish preference of patients with erectile dysfunction after taking the three PDE-5 inhibitors. J Sex Med 2006; 3: 901–9.
- 42 Akin-Olugbade O, Parker M, Guhring P, Mulhall J. Determinants of patient satisfaction following penile prosthesis surgery. J Sex Med 2006; 3: 743–8.
- 43 Mulhall JP, Levine LA, JünemannKP. Erection hardness, a unifying factor for defining response in the treatment of erectile dysfunction. Urology 2006; 68: 17–25.
- 44 King R, Juenemann KP, Levinson IP, Stecher VJ, Creanga DL. Correlations between increased erection hardness and improvements in emotional well-being and satisfaction outcomes in men treated with sildenafil citrate for erectile dysfunction. Int J Impot Res 2007; 19: 398–406.
- 45 Montorsi F, Padma-Nathan H, Glina S. Erectile function and assessments of erection hardness correlate positively with measures of emotional well-being, sexual satisfaction, and treatment satisfaction in men with erectile dysfunction treated with sildenafil citrate (Viagra). Urology 2006; 68: 26–37.
- 46 Rosen RC, Cappelleri JC, Gendrano N. The International Index of Erectile Function (IIEF): A state-of-the- science review. Int J Impot Res 2002; 14: 226–44.
- 47 Wincze J, Rosen R, Carson C, Korenman S, Niederberger C, Sadovsky R, McLeod L, Thibonnier M, Merchant S. Erection quality scale: Initial scale development and validation. Urology 2004; 64: 351–6.
- 48 DiBenedetti DB, Gondek K, Sagnier PP, Kubin M, Marquis P, Keininger D, Fugl-Meyer AR. The treatment satisfaction scale: A multidimensional instrument for the assessment of treatment satisfaction for erectile dysfunction patients and their partners. Eur Urol 2005; 48: 503–11.
- 49 Goldstein I, Kim E, Steers WD, Pryor JL, Wilde DW, Natanegara F, Wong DG, Ahuja S. Efficacy and safety of tadalafil in men with erectile dysfunction with a high prevalence of comorbid conditions: Results from MOMENTUS: Multiple observations in men with erectile dysfunction in National Tadalafil Study in the US. J Sex Med 2007; 4: 166–75.
