[Show abstract][Hide abstract] ABSTRACT: This article walks through some of the ideas behind patient-reported outcome measurement and quality-of-life research against the backdrop of urethral stricture disease and conditions of the lower urinary tract, more generally, why measurement matters at all, future areas for research and development and potential opportunities for misuse and manipulation.
It is the authors' opinion that only one published study has substantially advanced our understanding of the way men with urethral stricture disease manage this condition in the real world, and, in turn, the outcomes those men seek when they consent to surgery and its associated risks. There is, however, almost certainly greater acceptance now by reconstructive urologists of the utility of patient-reported outcome measures in audit; surgical performance evaluation; clinical research; and fair, logical and transparent healthcare resource allocation at a population level. This is evidenced by the recent proliferation of studies incorporating patient-reported outcomes, which appear today to be on parity at least with those that surgeons historically gave priority to.
The next frontier in urethral stricture disease outcomes research is a better understanding of the impact of this condition on men's daily lives. That level of insight is likely to be gained through a mixture of qualitative and quantitative research methods applied to collaborative research ventures with men with the condition who, as those that have the most to gain and lose, must be majority stakeholders in this process.
Current opinion in urology 04/2015; 25(4). DOI:10.1097/MOU.0000000000000179 · 2.33 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND:
Intermittent urethral self-dilatation is sometimes recommended to reduce the risk of recurrent urethral stricture. There is no consensus as to whether it is a clinically effective or cost-effective intervention in the management of this disease.
The purpose of this review is to evaluate the clinical effectiveness and cost-effectiveness of intermittent self-dilatation after urethral stricture surgery in males compared to no intervention. We also compared different programmes of, and devices for, intermittent self-dilatation. . SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register (searched 7 May 2014), CENTRAL (2014, Issue 4), MEDLINE (1 January 1946 to Week 3April 2014), PREMEDLINE (covering 29 April 2014), EMBASE (1 January 1947 to Week 17 2014), CINAHL (31 December 1981 to 30 April 2014) OpenGrey (searched 6 May 2014), ClinicalTrials.gov (6 May 2014), WHO International Clinical Trials Registry Platform (6 May 2014), Current Controlled Trials (6 May 2014) and the reference lists of relevant articles.
Randomised and quasi-randomised trials where one arm was a programme of intermittent self-dilatation for urethral stricture were identified. Studies were excluded if they were not randomised or quasi-randomised trials, or if they pertained to clean intermittent self-catheterisation for bladder emptying.
DATA COLLECTION AND ANALYSIS:
Two authors screened the records for relevance and methodological quality. Data extraction was performed according to predetermined criteria using data extraction forms. Analyses were carried out in Cochrane Review Manager (RevMan 5). The primary outcomes were patient-reported symptoms and health-related quality of life, and risk of recurrence; secondary outcomes were adverse events, acceptability of the intervention to patients and cost-effectiveness. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Eleven trials were selected for inclusion in the review, including a total of 776 men. They were generally small; all were of poor quality and all were deemed to have high risk of bias. Performing intermittent self-dilatationversus not performing intermittent self-dilatationThe data from six trials were heterogeneous, imprecise and had a high risk of bias, but indicated that recurrent urethral stricture was less likely in men who performed intermittent self-dilatation than men who did not perform intermittent self-dilatation (RR 0.70, 95% CI 0.48 to 1.00; very low quality evidence). Adverse events were generally poorly reported: two trials did not report adverse events and two trials reported adverse events only for the intervention group. Meta-analysis of the remaining two trials found no evidence of a difference between performing intermittent self-dilatation and not performing it (RR 0.60, 95% CI 0.11 to 3.26). No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness. One programme of intermittent self-dilatationversus anotherWe identified two trials that compared different durations of intermittent self-dilatation, but data were not combined. One study could not draw robust conclusions owing to cross-over, protocol deviation, administrative error, post-hoc analysis and incomplete outcome reporting. The other study found no evidence of a difference between intermittent self-dilatation for six months versus for 12 months after optical urethrotomy (RR 0.67, 95% CI 0.12 to 3.64), although again the evidence is limited by the small sample size and risk of bias in the included study. Adverse events were reported narratively and were not stratified by group. No trials formally assessed acceptability, and no trials reported on patient-reported lower urinary tract symptoms, patient-reported health-related quality of life, or cost-effectiveness. One device for performing intermittent self-dilatationversus anotherThree trials compared one device for performing intermittent self-dilatation with another. Results from one trial at a high risk of bias were too uncertain to determine the effects of a low friction hydrophilic catheter and a standard polyvinyl chloride catheter on the risk of recurrent urethral stricture (RR 0.32, 95% CI 0.07 to 1.40). Similarly one study did not find evidence of a difference between one percent triamcinolone gel for lubricating the intermittent self-dilatation catheter versus water-based gel on risk of recurrent urethral stricture (RR 0.68, 95% CI 0.35 to 1.32). Two trials reported adverse events, but one did not provide sufficient detail for analysis. The other small study reported fewer instances of prostatitis, urethral bleeding or bacteriuria with a low friction hydrophilic catheter compared with a standard polyvinyl chloride catheter (RR 0.13, 95% CI 0.02 to 0.98). 'Happiness with the intervention' was assessed using a non-validated scale in one study, but no trials formally assessed patient-reported health-related quality of life or acceptability. No trials reported on patient-reported lower urinary tract symptoms or cost-effectiveness. GRADE quality assessmentThe evidence that intermittent self-dilatation reduces the risk of recurrent urethral stricture after surgical intervention was downgraded to 'very low' on the basis that the studies comprising the meta-analysis were deemed to have high risk of bias, and the data was imprecise and inconsistent. Insufficient evidenceNo trials provided cost-effectiveness data or used a validated patient-reported outcome measure, and adverse events were not reported rigorously. Acceptability of the intervention to patients has not been assessed quantitatively or qualitatively.
Performing intermittent self-dilatation may confer a reduced risk of recurrent urethral stricture after endoscopic treatment. We have very little confidence in the estimate of the effect owing to the very low quality of the evidence. Evidence for other comparisons and outcomes is limited. Further research is required to determine whether the apparent benefit is sufficient to make the intervention worthwhile, and in whom.
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Studies of interventions for urethral stricture have inferred patient benefit from clinician-driven outcomes or questionnaires lacking scientifically robust evidence of their measurement properties for men with this disease. OBJECTIVE: To evaluate urethral reconstruction from the patients' perspective using a validated patient-reported outcome measure (PROM). DESIGN, SETTING, AND PARTICIPANTS: Forty-six men with anterior urethral stricture at four UK urology centres completed the PROM before (baseline) and 2 yr after urethroplasty. INTERVENTION: A psychometrically robust PROM for men with urethral stricture disease. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Lower urinary tract symptoms (LUTS), health status, and treatment satisfaction were measured, and paired t and Wilcoxon matched-pairs tests were used for comparative analysis. RESULTS AND LIMITATIONS: Thirty-eight men underwent urethroplasty for bulbar stricture and eight for penile stricture. The median (range) follow-up was 25 (20-30) mo. Total LUTS scores (0 = least symptomatic, 24 = most symptomatic) improved from a median of 12 at baseline to 4 at 2 yr (mean [95% confidence interval (CI)] of differences 6.6 [4.2-9.1], p < 0.0001). A total of 33 men (72%) felt their urinary symptoms interfered less with their overall quality of life, 8 (17%) reported no change, and 5 (11%) were worse 2 yr after urethroplasty. Overall, 40 men (87%) remained "satisfied" or "very satisfied" with the outcome of their operation. Health status visual analogue scale scores (100 = best imaginable health, 0 = worst) 2 yr after urethroplasty improved from a mean of 69 at baseline to 79 (mean [95% CI] of differences 10 [2-18], p = 0.018). Health state index scores (1 = full health, 0 = dead) improved from 0.79 at baseline to 0.89 at 2 yr (mean [95% CI] of differences 0.10 [0.02-0.18), p = 0.012]). CONCLUSIONS: This is the first study to prospectively evaluate urethral reconstruction using a validated PROM. Men reported continued relief from symptoms with related improvements in overall health status 2 yr after urethroplasty. These data can be used as a provisional reference point against which urethral surgeons can benchmark their performance.
European Urology 05/2013; 64(5). DOI:10.1016/j.eururo.2013.04.037 · 13.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: A systematic literature review did not identify a formally validated patient-reported outcome measure (PROM) for urethral stricture surgery.
Devise a PROM for urethral stricture surgery and evaluate its psychometric properties in a pilot study to determine suitability for wider implementation.
Constructs were identified from existing condition-specific and health-related quality of life (HRQoL) instruments. Men scheduled for urethroplasty were prospectively enrolled at five centres.
Participants self-completed the draft PROM before and 6 mo after surgery.
Question sets underwent psychometric assessment targeting criterion and content validity, test-retest reliability, internal consistency, acceptability, and responsiveness.
A total of 85 men completed the preoperative PROM, with 49 also completing the postoperative PROM at a median of 146 d; and 31 the preoperative PROM twice at a median interval of 22 d for test-retest analysis. Expert opinion and patient feedback supported content validity. Excellent correlation between voiding symptom scores and maximum flow rate (r = -0.75), supported by parallel improvements in EQ-5D visual analogue and time trade-off scores, established criterion validity. Test-retest intraclass correlation coefficients ranged from 0.83 to 0.91 for the total voiding score and 0.93 for the construct overall; Cronbach's α was 0.80, ranging from 0.76 to 0.80 with any one item deleted. Item-total correlations ranged from 0.44 to 0.63. These values surpassed our predefined thresholds for item inclusion. Significant improvements in condition-specific and HRQoL components following urethroplasty demonstrated responsiveness to change (p < 0.0001). Wider implementation and review of the PROM will be required to establish generalisability across different disease states and for more complex interventions.
This pilot study has defined a succinct, practical, and psychometrically robust PROM designed specifically to quantify changes in voiding symptoms and HRQoL following urethral stricture surgery.
European Urology 03/2011; 60(1):60-8. DOI:10.1016/j.eururo.2011.03.003 · 13.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Patient-reported outcome measures (PROMs) are now recognised as the most appropriate instruments to assess the effectiveness of healthcare interventions from the patient's perspective. The purpose of this review was to identify recent publications describing the use of PROMs following reconstructive urological surgery.
A wide systematic search identified only three original articles published in the last 2 years that prospectively assessed effectiveness using a patient-completed condition-specific or generic health-related quality of life (HRQoL) instrument. These publications illustrate the need to administer PROMs at a postoperative interval relevant to the anticipated recovery phase of individual procedures. They also highlight the difference in responsiveness of generic HRQoL instruments to symptomatic improvement between straightforward conditions such as pelviureteric junction obstruction and complex multidimensional conditions such as meningomyelocele.
PROMs uptake and awareness is increasing in reconstructive urology but more work is required to demonstrate the effectiveness of surgical procedures for patients and healthcare funders alike. Healthcare policy-makers now rely on these measures to determine whether specific treatments are worth financing and to compare outcomes between institutions.
Current opinion in urology 11/2010; 20(6):495-9. DOI:10.1097/MOU.0b013e32833cf4a5 · 2.33 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Leydig cell tumors are the most common interstitial neoplasm of the testes. Metastatic progression is historically quoted at over 10%, fuelling uncertainty as to the safety of testis sparing surgery. Between June 1998 and March 2009, 29 patients underwent surgery for Leydig cell tumor of the testis in our cancer network. We reviewed their histological features and clinical outcomes. Four patients with sub-5 millimetre lesions underwent testis sparing surgery and 25 were treated with radical orchidectomy. Histopathological characteristics that have been linked with risk of malignant progression were seen infrequently in our cohort: diameter greater than 50 mm, 0%; nuclear atypia, 14%; >3 mitoses per 10 high-power fields, 3%; infiltrative borders, 10%; necrosis, 3%; and vascular invasion 0%. No patient developed local or distant recurrent disease over a median follow up of 49 months, including seven and four patients disease-free at 5 and 10 years, respectively. The rate of metastatic progression is likely to be significantly less than 10%. Our data suggest that, in the absence of high-risk histopathological features, this tumor can be safely regarded as benign, pending a longer-term follow-up evaluation.
International Journal of Urology 10/2010; 17(10):886-9. DOI:10.1111/j.1442-2042.2010.02616.x · 2.41 Impact Factor