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Published in: International Urogynecology Journal 7/2011

01-07-2011 | Original Article

Validity and reliability of patient selected goals as an outcome measure in overactive bladder

Authors: Rufus Cartwright, Sushma Srikrishna, Linda Cardozo, Dudley Robinson

Published in: International Urogynecology Journal | Issue 7/2011

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Abstract

Introduction and hypothesis

The purpose of this study is to assess the validity of patient goal achievement in overactive bladder (OAB).

Methods

Data were taken from a placebo-controlled randomised trial of transdermal oxybutynin and open label extension study. Face validity was assessed using qualitative analysis. Convergent validity was assessed by comparison with objective symptom improvement. Responsiveness was assessed at 4 s, using the standardised effect size. Reliability was assessed between 4 and 12 weeks of treatment.

Results

Ninety-six women were randomised. There were moderate correlations (0.50–0.51) between goal achievement and symptom improvement for urinary urgency and urge incontinence. Mean goal achievement demonstrated good reliability (intraclass correlation = 0.82) but low responsiveness (r = 0.14) between transdermal oxybutynin and placebo-treated groups.

Conclusions

Although patient goals have good face validity and can be reliably measured, they have limited convergence with conventional measures of OAB severity and improvement and low responsiveness.
Literature
1.
go back to reference Khullar V, Chapple C, Gabriel Z, Dooley JA (2006) The effects of antimuscarinics on health-related quality-of-life in overactive bladder: a systematic review and meta-analysis. Urology 68:38–48PubMedCrossRef Khullar V, Chapple C, Gabriel Z, Dooley JA (2006) The effects of antimuscarinics on health-related quality-of-life in overactive bladder: a systematic review and meta-analysis. Urology 68:38–48PubMedCrossRef
2.
go back to reference Lowenstein L, Fitzgerald MP, Kenton K, Dooley Y, Templehof M, Mueller ER et al (2007) Patient-selected goals: the fourth dimension in assessment of pelvic floor disorders. Int Urogynecol J Pelvic Floor Dysfunct 19:81–84PubMedCrossRef Lowenstein L, Fitzgerald MP, Kenton K, Dooley Y, Templehof M, Mueller ER et al (2007) Patient-selected goals: the fourth dimension in assessment of pelvic floor disorders. Int Urogynecol J Pelvic Floor Dysfunct 19:81–84PubMedCrossRef
3.
go back to reference Brubaker L, Shull B (2005) EGGS for patient-centered outcomes. Int Urogynecol J Pelvic Floor Dysfunct 16:171–173PubMedCrossRef Brubaker L, Shull B (2005) EGGS for patient-centered outcomes. Int Urogynecol J Pelvic Floor Dysfunct 16:171–173PubMedCrossRef
4.
go back to reference Hullfish KL, Bovbjerg VE, Gibson J, Steers WD (2002) Patient-centered goals for pelvic floor dysfunction surgery: what is success, and is it achieved? Am J Obstet Gynecol 187:88–92PubMedCrossRef Hullfish KL, Bovbjerg VE, Gibson J, Steers WD (2002) Patient-centered goals for pelvic floor dysfunction surgery: what is success, and is it achieved? Am J Obstet Gynecol 187:88–92PubMedCrossRef
5.
go back to reference Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L (2003) Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol 189:1551–1557, discussion 1557–1558PubMedCrossRef Elkadry EA, Kenton KS, FitzGerald MP, Shott S, Brubaker L (2003) Patient-selected goals: a new perspective on surgical outcome. Am J Obstet Gynecol 189:1551–1557, discussion 1557–1558PubMedCrossRef
6.
go back to reference Hullfish KL, Bovbjerg VE, Steers WD (2004) Patient-centered goals for pelvic floor dysfunction surgery: long-term follow-up. Am J Obstet Gynecol 191:201–205PubMedCrossRef Hullfish KL, Bovbjerg VE, Steers WD (2004) Patient-centered goals for pelvic floor dysfunction surgery: long-term follow-up. Am J Obstet Gynecol 191:201–205PubMedCrossRef
7.
go back to reference Bovbjerg VE, Trowbridge ER, Barber MD, Martirosian TE, Steers WD, Hullfish KL (2009) Patient-centered treatment goals for pelvic floor disorders: association with quality-of-life and patient satisfaction. Am J Obstet Gynecol 200:568.e1–568.e6CrossRef Bovbjerg VE, Trowbridge ER, Barber MD, Martirosian TE, Steers WD, Hullfish KL (2009) Patient-centered treatment goals for pelvic floor disorders: association with quality-of-life and patient satisfaction. Am J Obstet Gynecol 200:568.e1–568.e6CrossRef
8.
go back to reference Payne C, Allee T (2009) Goal achievement provides new insights into interstitial cystitis/painful bladder syndrome symptoms and outcomes. Neurourol Urodyn 28:13–17PubMedCrossRef Payne C, Allee T (2009) Goal achievement provides new insights into interstitial cystitis/painful bladder syndrome symptoms and outcomes. Neurourol Urodyn 28:13–17PubMedCrossRef
9.
go back to reference Komesu YM, Rogers RG, Rode MA, Craig EC, Schrader RM, Gallegos KA et al (2008) Patient-selected goal attainment for pessary wearers: what is the clinical relevance? Am J Obstet Gynecol 198:577.e1–577.e5CrossRef Komesu YM, Rogers RG, Rode MA, Craig EC, Schrader RM, Gallegos KA et al (2008) Patient-selected goal attainment for pessary wearers: what is the clinical relevance? Am J Obstet Gynecol 198:577.e1–577.e5CrossRef
10.
go back to reference Hullfish KL, Bovbjerg VE, Gurka MJ, Steers WD (2008) Surgical versus nonsurgical treatment of women with pelvic floor dysfunction: patient centered goals at 1 year. J Urol 179:2280–2285, discussion 2285PubMedCrossRef Hullfish KL, Bovbjerg VE, Gurka MJ, Steers WD (2008) Surgical versus nonsurgical treatment of women with pelvic floor dysfunction: patient centered goals at 1 year. J Urol 179:2280–2285, discussion 2285PubMedCrossRef
11.
go back to reference Brubaker L, Shott S, Tomezsko J, Goldberg RP (2008) Pelvic floor fitness using lay instructors. Obstet Gynecol 111:1298–1304PubMedCrossRef Brubaker L, Shott S, Tomezsko J, Goldberg RP (2008) Pelvic floor fitness using lay instructors. Obstet Gynecol 111:1298–1304PubMedCrossRef
12.
go back to reference Choo MS, Doo CK, Lee KS (2007) Satisfaction with tolterodine: assessing symptom-specific patient-reported goal achievement in the treatment of overactive bladder in female patients (STARGATE study). Int J Clin Pract 62:191–196PubMedCrossRef Choo MS, Doo CK, Lee KS (2007) Satisfaction with tolterodine: assessing symptom-specific patient-reported goal achievement in the treatment of overactive bladder in female patients (STARGATE study). Int J Clin Pract 62:191–196PubMedCrossRef
13.
go back to reference Brubaker G, Sand D (2009) Botulinum toxin type A (Botox®) demonstrates dose-dependent efficacy and improvements in quality-of-life measures in patients with idiopathic overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct 20:S191–S192 Brubaker G, Sand D (2009) Botulinum toxin type A (Botox®) demonstrates dose-dependent efficacy and improvements in quality-of-life measures in patients with idiopathic overactive bladder. Int Urogynecol J Pelvic Floor Dysfunct 20:S191–S192
14.
go back to reference Chapple CR, Artibani W, Cardozo LD, Castro-Diaz D, Craggs M, Haab F et al (2005) The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospects. BJU Int 95:335–340PubMedCrossRef Chapple CR, Artibani W, Cardozo LD, Castro-Diaz D, Craggs M, Haab F et al (2005) The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospects. BJU Int 95:335–340PubMedCrossRef
15.
go back to reference Mahajan ST, Elkadry EA, Kenton KS, Shott S, Brubaker L (2006) Patient-centered surgical outcomes: the impact of goal achievement and urge incontinence on patient satisfaction 1 year after surgery. Am J Obstet Gynecol 194:722–728PubMedCrossRef Mahajan ST, Elkadry EA, Kenton KS, Shott S, Brubaker L (2006) Patient-centered surgical outcomes: the impact of goal achievement and urge incontinence on patient satisfaction 1 year after surgery. Am J Obstet Gynecol 194:722–728PubMedCrossRef
16.
go back to reference Srikrishna R, Cardozo C (2007) Defining surgical cure: do surgical goals meet patient expectations? Neurourol Urodyn 26:596–597 Srikrishna R, Cardozo C (2007) Defining surgical cure: do surgical goals meet patient expectations? Neurourol Urodyn 26:596–597
17.
go back to reference Lee S, Malhotra B, Creanga D, Carlsson M, Glue P (2009) A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder. BMC Med Res Methodol 22(9):55CrossRef Lee S, Malhotra B, Creanga D, Carlsson M, Glue P (2009) A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder. BMC Med Res Methodol 22(9):55CrossRef
18.
go back to reference Cartwright R, Srikrishna S, Cardozo L, Robinson D (2010) Patient-selected goals in overactive bladder: a placebo controlled randomized double-blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence. BJU Int 107(1):70–76CrossRef Cartwright R, Srikrishna S, Cardozo L, Robinson D (2010) Patient-selected goals in overactive bladder: a placebo controlled randomized double-blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence. BJU Int 107(1):70–76CrossRef
19.
go back to reference Cardozo L, Heßdörfer E, Milani R, Arañó P, Dewilde L, Slack M et al (2008) Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int 102:1120–1127PubMedCrossRef Cardozo L, Heßdörfer E, Milani R, Arañó P, Dewilde L, Slack M et al (2008) Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int 102:1120–1127PubMedCrossRef
20.
go back to reference Kelleher CJ, Cardozo LD, Khullar V, Salvatore S (1997) A new questionnaire to assess the quality-of-life of urinary incontinent women. Br J Obstet Gynaecol 104:1374–1379PubMedCrossRef Kelleher CJ, Cardozo LD, Khullar V, Salvatore S (1997) A new questionnaire to assess the quality-of-life of urinary incontinent women. Br J Obstet Gynaecol 104:1374–1379PubMedCrossRef
21.
go back to reference Kelleher CJ, Pleil AM, Reese PR, Burgess SM, Brodish PH (2004) How much is enough and who says so? BJOG 111:605–612PubMedCrossRef Kelleher CJ, Pleil AM, Reese PR, Burgess SM, Brodish PH (2004) How much is enough and who says so? BJOG 111:605–612PubMedCrossRef
22.
go back to reference Lowenstein L, Kenton K, Pierce K, Fitzgerald MP, Mueller ER, Brubaker L (2007) Patients’ pelvic goals change after initial urogynecologic consultation. Am J Obstet Gynecol 197:640.e1–640.e3CrossRef Lowenstein L, Kenton K, Pierce K, Fitzgerald MP, Mueller ER, Brubaker L (2007) Patients’ pelvic goals change after initial urogynecologic consultation. Am J Obstet Gynecol 197:640.e1–640.e3CrossRef
23.
go back to reference Srikrishna S, Robinson D, Cardozo L, Cartwright R (2008) Experiences and expectations of women with urogenital prolapse: a quantitative and qualitative exploration. BJOG 115:1362–1368PubMedCrossRef Srikrishna S, Robinson D, Cardozo L, Cartwright R (2008) Experiences and expectations of women with urogenital prolapse: a quantitative and qualitative exploration. BJOG 115:1362–1368PubMedCrossRef
24.
go back to reference Milne JL, Robert M, Tang S, Drummond N, Ross S (2009) Goal achievement as a patient-generated outcome measure for stress urinary incontinence. Health Expect 12:288–300PubMedCrossRef Milne JL, Robert M, Tang S, Drummond N, Ross S (2009) Goal achievement as a patient-generated outcome measure for stress urinary incontinence. Health Expect 12:288–300PubMedCrossRef
25.
go back to reference Cotterill N, Norton C, Avery KN, Abrams P, Donovan JL (2008) A patient-centered approach to developing a comprehensive symptom and quality-of-life assessment of anal incontinence. Dis Colon Rectum 51:82–87PubMedCrossRef Cotterill N, Norton C, Avery KN, Abrams P, Donovan JL (2008) A patient-centered approach to developing a comprehensive symptom and quality-of-life assessment of anal incontinence. Dis Colon Rectum 51:82–87PubMedCrossRef
26.
go back to reference Hróbjartsson A, Gøtzsche PC (2004) Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med 256:91–100PubMedCrossRef Hróbjartsson A, Gøtzsche PC (2004) Is the placebo powerless? Update of a systematic review with 52 new randomized trials comparing placebo with no treatment. J Intern Med 256:91–100PubMedCrossRef
27.
go back to reference Meissner K, Distel H, Mitzdorf U (2007) Evidence for placebo effects on physical but not on biochemical outcome parameters: a review of clinical trials. BMC Med 5:3PubMedCrossRef Meissner K, Distel H, Mitzdorf U (2007) Evidence for placebo effects on physical but not on biochemical outcome parameters: a review of clinical trials. BMC Med 5:3PubMedCrossRef
28.
go back to reference von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP et al (2007) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 147:573–577 von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP et al (2007) The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med 147:573–577
Metadata
Title
Validity and reliability of patient selected goals as an outcome measure in overactive bladder
Authors
Rufus Cartwright
Sushma Srikrishna
Linda Cardozo
Dudley Robinson
Publication date
01-07-2011
Publisher
Springer-Verlag
Published in
International Urogynecology Journal / Issue 7/2011
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-011-1360-0

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