Validation of the Patient Global Impression scales for use in detrusor overactivity: secondary analysis of the RELAX study

Abstract

Objective To assess construct validity of the Patient Global Impression scales (Severity [PGI-S], Bother [PGI-B] and Improvement [PGI-I]) for symptoms of detrusor overactivity (DO).Design Secondary analysis of a randomised trial of onabotulinum toxin A.Setting Eight UK urogynaecology departments.Population A total of 240 women with DO refractory to medical treatment randomised to receive 200 iu onabotulinum toxin A or placebo in the RELAX trial and followed up for 6 months.Main outcome measures Urinary diaries and disease-specific quality of life (QoL) questionnaires were completed at baseline and during follow up. Discriminatory ability of the PGI-S, PGI-B and PGI-I scales to identify symptom severity and change in severity was assessed by comparing mean diary and QoL outcomes across the response categories, analysed by one-way analysis of variance.Results Data were available from 237 women (98.8%) for validation of PGI-S and PGI-B at baseline, and 192 women (80%) at 6 weeks follow up for validation of PGI-I. Leakage episodes (P = 0.01), urgency episodes (P = 0.019), urgency severity (P = 0.012), and QoL scores (all P < 0.001) were greater in women with more severe problems on PGI-S. Similar results were seen for PGI-B: leakage (P = 0.051), urgency episodes (P < 0.001), urgency severity (P < 0.001), and QoL scores (all P < 0.001). PGI-I responses demonstrated significant relationships with size of change of all variables (P < 0.001). The generic instrument EQ-5D had weaker relationships (PGI-S, P = 0.09; PGI-B, P = 0.004; PGI-I, P = 0.06), suggesting that it was less sensitive.Conclusions The PGI scales are robust and valid instruments to assess disease severity, bother and improvement after treatment in women with detrusor overactivity.

Quality of life after suprapubic catheter placement in patients with neurogenic bladder conditions

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Is self‐reported adherence associated with clinical outcomes in women treated with anticholinergic medication for overactive bladder?

“…The Patient Global Impression of Improvement is a validated 7‐point scale, ranging from “very much better” to “very much worse” that compares symptoms at 8 weeks to before treatment. It has been validated for use in women undergoing treatment for OAB . Women were defined as having improvement in their symptoms if they reported that their symptoms were “little better,” “much better,” or “very much better” compared to baseline.…”

The Effect of Vaginal Oestriol Cream on Subjective and Objective Symptoms of Stress Urinary Incontinence and Vaginal Atrophy: An International Multi-Centre Pilot Study

“…The PGI-I is a 1-item questionnaire with a 7-point Likert scale developed and validated to measure the change of symptoms [16] . The PGI-I response has been shown to correlate 17 significantly with the frequency of incontinence episodes, coughtest results, pad-test results, and scores on several incontinence quality of life questionnaires [17] .…”