Validation of two global impression questionnaires for incontinence

doi:10.1067/mob.2003.379

American Journal of Obstetrics and Gynecology

Volume 189, Issue 1, July 2003, Pages 98-101

Presented at the Twenty-Third Annual Meeting of the American UroGynecologic Society, San Francisco, Calif, October 6-118, 2002.

https://doi.org/10.1067/mob.2003.379 Get rights and content

Abstract

Objective: The purpose of this study was to assess the construct validity of two global assessment questions, the Patient Global Impression of Severity and of Improvement, in female patients with stress urinary incontinence. Study Design: This was a secondary analysis of data from two double-blind, placebo-controlled studies that evaluated duloxetine for the treatment of predominant stress urinary incontinence in the United States (n = 1133 patients). Assessment variables included incontinence episode frequency, the Incontinence Quality of Life Questionnaire results, fixed volume (400 mL) stress pad test results, and the Patient Global Impression of Improvement and of Severity question results. Results: Spearman correlation coefficients were 0.36, 0.20, and −0.50 among the Patient Global Impression of Severity question and incontinence episode frequency, stress pad test, and Incontinence Quality of Life Questionnaire results, respectively (all P <.0001). Mean incontinence episode frequency and median stress pad test results increased and mean Incontinence Quality of Life Questionnaire results decreased with increasing Patient Global Impression of Severity question severity levels. Similarly, significant (P <.0001) correlations were observed between the Patient Global Impression of Improvement question response categories and the three independent measures of improvement in stress urinary incontinence (0.49, 0.33, and −0.43 with incontinence episode frequency, stress pad test, and Incontinence Quality of Life Questionnaire results, respectively). As with the Patient Global Impression of Severity question, differences in mean changes for Incontinence Quality of Life Questionnaire and median percent changes for incontinence episode frequency and stress pad test among the Patient Global Impression of Improvement question response categories were highly significant (P <.0001). These relationships indicate appropriate and significant associations between the Patient Global Impression of Severity and of Improvement questions and the three independent measures of stress urinary incontinence severity and improvement, respectively. Conclusion: The Patient Global Impression of Severity and of Improvement question responses were correlated significantly with incontinence episode frequency, stress pad test, and Incontinence Quality of Life Questionnaire measures, which established the construct validity of these two global assessment questions for baseline severity and treatment response, respectively. (Am J Obstet Gynecol 2003;189:98-101.)

Section snippets

Participants

Women with urinary incontinence of at least 3 months duration were enrolled in two double-blind, placebo-controlled, randomized clinical trials. The first trial was a phase II dose finding study (duloxetine 20, 40, and 80 mg/d) that was conducted at 48 study centers in the United States, the details of which have been previously published (n = 553 patients).⁹ The second study was a phase III study that was conducted in United States (n = 580 patients, 52 study centers) and Canada (n = 103

Results

A total of 1133 women entered the trials in the United States and were assigned randomly to receive duloxetine 20 mg/d (n = 138 women), duloxetine 40 mg/d (n = 137 women), duloxetine 80 mg/d (n = 433 women), or placebo (n = 425 women) therapy. Overall, the mean age was 51.1 ± 9.8 (SD) years, and the mean body mass index was 29.3 ± 6.5 kg/m². Most of the subjects (91%) were white. None of these characteristics differed significantly among treatment groups. Self-reported ratings of urinary tract

Comment

The data from these combined studies indicate that the PGI-S and PGI-I responses were correlated significantly with incontinence episode frequency, stress pad test, and I-QOL measures, which established the construct validity of the 2 global assessment indexes for baseline severity and for treatment response, respectively, in a population of women in the United States with SUI. The PGI-I and PGI-S were modeled after scales that were described previously and used successfully in

References (13)

LL Wall et al.
Evaluating the outcome of surgery for pelvic organ prolapse
Am J Obstet Gynecol
(1998)
PA Norton et al.
Duloxetine versus placebo in the treatment of stress urinary incontinence
Am J Obstet Gynecol
(2002)
TH Wagner et al.
Quality of life of persons with urinary incontinence: development of a new measure
Urology
(1996)
DL Patrick et al.
Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL)
Urology
(1999)
J Donovan et al.
Symptom and quality of life assessment
A Mattiasson et al.
Research methodology in incontinence

There are more references available in the full text version of this article.

Cited by (706)

Mid- to long-term results of Polyacrylamide Hydrogel (Bulkamid®) as recourse for female stress urinary incontinence
2024, Continence
We aimed to assess the mid- to long-term outcome of Polyacrylamide Hydrogel urethral injections as a treatment for women with stress urinary incontinence (SUI), who are not eligible for treatment with midurethral slings.
We performed a single-arm, patient cohort study using the subjective improvement rate as primary outcome, defined as an answer “(very) much better” on the Patient Global Impression of Improvement. Secondary outcomes were the subjective cure rate (a negative answer to the Urogenital Distress Inventory stress subscale question 4), patient satisfaction (Visual Analogue Scale of $\geq$ 8.0), complication rate, the amount of Hydrogel injected, the number of reinjections and to what extent patients would recommend this treatment.
A total of 357 women with pure SUI, or mixed urinary incontinence with predominant SUI were included. Adverse events were retrieved from their patient records and all received a questionnaire, which was completed and returned by 153 (42.9%) women. After a median follow-up of two and a half years, the subjective improvement rate was 52.1%. The subjective cure rate was 30.9%. A satisfaction score of $\geq$ 8.0 was achieved in 48.6% of the patient group. Minor adverse events due to the procedure were reported in 21% of patients. No serious adverse events were noted.
This study demonstrates that Polyacrylamide Hydrogel, even after a mid- to long-term follow-up, is a valuable treatment option for women with SUI, who are ineligible for midurethral sling surgery. No serious adverse events related to the procedure were reported during the follow-up period.
Assessment of voiding difficulties in men with idiopathic Parkinson ’s disease
2024, Continence
Distinction between the impact of Parkinson’s disease (PD) or age-related lower urinary tract disorders such as benign prostatic hyperplasia (BPH) can be difficult in patients reporting voiding difficulties (VD). This study aimed to describe the causes of VD in men with PD, and to compare clinical and urodynamic parameters according to the mechanism.
This retrospective study included men with PD reporting VD, for whom pressure-flow studies were performed. Findings of urodynamics, voiding cystourethrogram (VCUG), and prostatic weight were collected. BPH was defined as a prostatic weight >30 cc. Urodynamic obstruction and underactivity were defined using the Bladder Outlet Obstruction Index >40 and the Bladder Contractility Index <100 respectively.
Forty-one patients were included (median age 70 (IQR: 66-74)). Twenty-nine (71%) had bladder obstruction. The maximum flow rate was lower (6.8 ± 2.6 ml/s vs 13.6 ± 2.3 ml/s; p<0.001) and the post-void residual was higher in the obstructed group (99 ± 133 ml vs 9 ± 16 ml; p $=$ 0.002). Ten patients (24%) had detrusor underactivity.
Among patients with obstruction, eighteen (62%) had BPH and seven (24%) did not. Eleven obstructed patients underwent a VCUG: only one patient among the seven with BPH presented incomplete bladder neck opening compared to six among the seven patients without BPH (p $=$ 0.02).
VD in patients with PD is more frequently related to bladder outlet obstruction. BPH is the primary cause, but tight bladder neck and detrusor underactivity, probably secondary to PD, must be considered. Thus, a detailed assessment of urinary disorders in this population is crucial.
Safety and Efficacy Report for the Use of Poly-4-Hydroxybutyrate as a Retropubic Mid-Urethral Sling (MUS) for Stress Urinary Incontinence: A Prospective 24 Months Follow-Up of New Poly-4-Hydroxybutyrate TephaFlex SUI Bioresorbable MUS
2024, Journal of Minimally Invasive Gynecology
To investigate the feasibility and safety of the retropubic mid-urethral sling (MUS) procedure with a resorbable mesh implant made of poly-4-hydroxybutyrate (P4HB).
A prospective clinical cohort study with 24 months follow-up.
A tertiary academic hospital.
Seventeen women with moderate to severe stress urinary incontinence (SUI).
A retropubic MUS procedure with P4HB sling.
Seventeen women underwent an uncomplicated MUS procedure with a new sling made of resorbable P4HB. Following safety criteria, there has been no need to stop the study before 24 months’ end point. Three serious adverse events were reported during follow-up: (1) inability to void urine after 1 week postsurgery, (2) a hysterectomy and bilateral oophorectomy performed due to a precancerous endometrial lesion at 16 months after initial MUS procedure and (3) exposed mesh with a part of device sheath left behind. These participants underwent an uncomplicated reintervention with no additional and/or permanent harm. Reinterventions because of failure of cure contained 3 second MUS procedures and one admission of urethral bulking agent. Seventy-six percent and 47 percent of patients were objectively cured of SUI at 12 and 24 months, respectively.
Preliminary evidence suggests that a sling made of P4HB can be safely used for MUS procedures and could be an alternative for permanent polypropylene slings in patients that prefer the use of nonpermanent material.
Algorithmic Midline Approach to Perineal Urethrostomy is Associated With Long-term Success and High Patient Satisfaction
2024, Urology
To assess surgical success and patient-reported outcomes of perineal urethrostomy via midline approach.
Charts of patients undergoing primary perineal urethrostomy between May 2008 and June 2022 were reviewed. Background characteristics were assessed; success was defined as freedom from re-intervention. Patient-reported outcome measures were assessed using a cross-sectional phone survey. Several validated questionnaires were used to assess lower urinary tract symptoms, quality of life, and erectile dysfunction.
Among 1768 urethroplasties performed over the study period, 103 patients (5.8%) underwent midline perineal urethrostomy. Surgery was successful in 95.1% of cases (98/103); 5 patients (4.9%) required re-intervention at a median of 8.7 months. Post-operative complications occurred in 5.8% of cases (6/103) and were both mild and self-limited. Forty-nine patients (47.6%) were reached via phone survey at a median of 61 months post-operatively. Some questions were not answered by all patients. Most patients (42/49, 86%) were satisfied or very satisfied with surgical results, and 82% (40/49) reported an improvement in their overall health. Most patients (31/41, 76%) were unbothered by sitting to urinate. Although 20% of patients (10/49) reported post-operative urinary symptoms that interfered “a lot” with their daily life, only 3 (6%) of these patients reported dissatisfaction with the outcome. Regarding sexual function, 64% (27/42) reported indifference to or increased satisfaction with sexual encounters vs before surgery. The rate of de novo erectile dysfunction was 24% (12/49).
The midline approach to perineal urethrostomy provides excellent, durable success rates with high levels of patient satisfaction.
Physician awareness of patients’ preferred level of involvement in decision-making at the initial urogynecology visit: a randomized trial
2024, American Journal of Obstetrics and Gynecology
Studies have shown up to a 40% discordance between patients’ preferred roles in decision-making before and their perceived roles after their visit. This can negatively affect patients’ experiences; interventions to minimize this discordance may significantly improve patient satisfaction.
We aimed to determine whether physicians’ awareness of patients’ preferred involvement in decision-making before their initial urogynecology visit affects patients’ perceived level of involvement after their visit.
This randomized controlled trial enrolled adult English-speaking women presenting for their initial visit at an academic urogynecology clinic from June 2022 to September 2022. Before the visit, participants completed the Control Preference Scale to determine the patient’s preferred level of decision-making: active, collaborative, or passive. The participants were randomized to either the physician team being aware of their decision-making preference before the visit or usual care. The participants were blinded. After the visit, participants again completed a Control Preference Scale and the Patient Global Impression of Improvement, CollaboRATE, patient satisfaction, and health literacy questionnaires. Fisher exact, logistic regression, and generalized estimating equations were used. Based on a 21% difference in preferred and perceived discordance, we calculated the sample size to be 50 patients in each arm to achieve 80% power.
Women (n=100) with a mean age of 52.9 years (standard deviation=15.8) participated in the study. Most participants identified as White (73%) and non-Hispanic (70%). Before the visit, most women preferred an active role (61%) and few preferred a passive role (7%). There was no significant difference between the 2 cohorts in the discordance between their pre- and post-Control Preference Scale responses (27% vs 37%; P=.39) or whether their symptoms were much better or very much better following the visit (18% vs 37%; P=.06). However, when asked whether they were completely satisfied with the visit, those assigned to the physician awareness cohort reported higher satisfaction than those in the treatment as usual cohort (100% vs 90%; P=.03).
Although there was no significant decrease in discordance between the patient's desired and perceived level of decision-making following physician awareness, it had a significant effect on patient satisfaction. All patients whose physicians were aware of their preferences reported complete satisfaction with their visit. Although patient-centered care does not always entail meeting all of the patients' expectations, the mere understanding of their preferences in decision-making can lead to complete patient satisfaction.
Patient Global Impression of Severity Scale in Chronic Cough: Validation and Formulation of Symptom Severity Categories
2023, Journal of Allergy and Clinical Immunology: In Practice
The Patient Global Impression of Severity (PGI-S) scale is a self-reported, single-item categorical scale that is increasingly used when assessing chronic cough (CC).
This study aimed to establish validity, repeatability, and responsiveness of the PGI-S scale in CC and use the scale to define discrete categories of severity when measured with other commonly used patient-reported outcome (PRO) tools.
Consecutive patients with CC completed the PGI-S scale, cough severity and urge to cough visual analog scales (VAS), and cough-specific health status Leicester Cough Questionnaire (LCQ) at a clinic visit. Validity, repeatability, and responsiveness were assessed, and threshold scores for PRO severity categories determined.
A total of 482 participants completed the assessments; the median (interquartile range [IQR]) age was 57 (46-67) years, 71% were female, and the median (IQR) duration of cough was 48 (24-120) months. They reported a median (IQR) PGI-S score of 3 (3-4; moderate severity), cough severity VAS of 57 (31-75) mm, urge to cough VAS of 62 (40-81) mm, and LCQ of 11.5 (8.7-14.4). There were strong associations between PGI-S scores and cough severity VAS (ρ = 0.81), urge to cough VAS (ρ = 0.73), and LCQ (ρ = −0.73) (all P < .001). Repeatability of the PGI-S scale was high (n = 77); the intraclass correlation coefficient (95% confidence interval) was 0.85 (0.77-0.91) (P < .001). The PGI-S scale was responsive in participants with a treatment response (P < .001). The suggested PRO thresholds to define severe cough are ≥61 mm (cough severity VAS), ≥71 mm (urge to cough VAS), and ≤10 (LCQ).
The PGI-S scale is a simple and valid tool that characterizes cough severity and is repeatable and responsive in CC. The proposed categorical severity thresholds for VAS and LCQ can provide intuitive meaning for patients and clinicians.

View all citing articles on Scopus

^☆: Supported by Eli Lilly and Company.

^☆☆: Reprint requests: Ilker Yalcin, Eli Lilly and Company Corporate Center, DC 6114, Indianapolis, IN 46285. E-mail: [email protected]

View full text

General Obstetrics and Gynecology GynecologyValidation of two global impression questionnaires for incontinence☆,☆☆

Abstract

Section snippets

Participants

Results

Comment

Am J Obstet Gynecol

Am J Obstet Gynecol

Urology

Urology

Symptom and quality of life assessment

Research methodology in incontinence

General Obstetrics and Gynecology Gynecology
Validation of two global impression questionnaires for incontinence☆,☆☆