Sara Brookes

A randomized trial comparing transurethral resection of the prostate, laser therapy and conservative treatment of men with symptoms associated with benign prostatic enlargement: The CLasP study.

PURPOSEnWe evaluated the effectiveness of a new technology (noncontact laser therapy) versus that of standard surgery (transurethral prostatic resection) and conservative management for lower urinary tract symptoms associated with benign prostatic enlargement.nnnMATERIALS AND METHODSnMen with uncomplicated lower urinary tract symptoms, that is no acute or chronic urinary retention, were randomized to receive laser therapy with a noncontact, side firing neodymium:YAG probe, standard transurethral prostatic resection or conservative management, including monitoring without active intervention, in a large multicenter pragmatic randomized controlled trial called the CLasP study. Primary outcomes were International Prostate Symptom Score (I-PSS), maximum urinary flow rate, a composite measure of success based on I-PSS and maximum urinary flow rate categories, I-PSS quality of life score and post-void residual urine volume. Secondary outcomes included treatment failure, hospital stay and major complications. Followup was 7.5 months after randomization. Intent to treat analysis was done using analysis of covariance, proportional odds models and the Newman-Keuls multiple comparisons procedure.nnnRESULTSnOf symptomatic patients 117, 117 and 106 were randomized to receive laser therapy, transurethral prostatic resection and conservative management, respectively. Baseline characteristics were similar. All primary outcomes indicated that transurethral prostatic resection and laser therapy were superior to conservative management, and resection was superior to laser therapy. As measured by combined improved symptoms and maximum urinary flow, a successful outcome was achieved in 81%, 67% and 15% of men who underwent transurethral prostatic resection, laser therapy and conservative management, respectively. Hospital stay was significantly shorter and complications fewer for laser therapy than for resection but catheters were in place significantly longer. Men treated conservatively did not have deterioration or treatment failure.nnnCONCLUSIONSnLaser therapy and transurethral prostatic resection are effective for decreasing lower urinary tract symptoms and post-void residual urine volume as well as improving quality of life and maximum urinary flow in the short term in men presenting with moderate to severe symptoms. Transurethral prostatic resection is superior to laser therapy in terms of effectiveness but some patients may elect laser therapy due to the shorter hospital stay and lower risk of complications. Conservative management may be acceptable and safe in men with lower urinary tract symptoms since we observed no marked deterioration in the short term.

The Bristol Shared Care Glaucoma Study: reliability of community optometric and hospital eye service test measures

BACKGROUND/AIMS Primary open angle glaucoma patients and glaucoma suspects make up a considerable proportion of outpatient ophthalmological attendances and require lifelong review. Community optometrists can be suitably trained for assessment of glaucoma. This randomised controlled trial aims to assess the ability of community optometrists in the monitoring of this group of patients. METHODS Measures of cup to disc ratio, visual field score, and intraocular pressure were taken by community optometrists, the hospital eye service and a research clinic reference “gold” standard in 405 stable glaucoma patients and ocular hypertensives. Agreement between and within the three centres was assessed using mean differences and intraclass correlation coefficients. Tolerance limits for a change in status at the level of individual pairs of measurements were also calculated. RESULTS Compared with a research clinic reference standard, measurements made by community optometrists and those made in the routine hospital eye service were similar. Mean measurement differences and variability were similar across all three groups compared for each of the test variables (IOP, cup to disc ratio, and visual field). Overall, the visual field was found to be the most reliable measurement and the cup to disc ratio the least. CONCLUSIONS Trained community optometrists are able to make reliable measurements of the factors important in the assessment of glaucoma patients and glaucoma suspects. This clinical ability should allow those optometrists with appropriate training to play a role in the monitoring of suitable patients.

A PROSPECTIVE RANDOMIZED TRIAL COMPARING TRANSURETHRAL RESECTION OF THE PROSTATE AND LASER THERAPY IN MEN WITH CHRONIC URINARY RETENTION: THE CLasP STUDY

PURPOSEnWe assessed the effectiveness of laser therapy versus transurethral prostatic resection in men with symptomatic chronic urinary retention secondary to benign prostatic enlargement.nnnMATERIALS AND METHODSnThis trial was multicenter, pragmatic and randomized. Analysis was done by intent to treat. Laser therapy involved neodymium:YAG noncontact visual prostate ablation, while transurethral prostatic resection was performed by standard electroresection. Patients were included in our study if they reported moderate to severe lower urinary tract symptoms with an International Prostate Symptom Score (I-PSS) of 8 or more, benign prostatic enlargement and a persistent post-void residual urine volume of more than 300 ml. Followup was 7.5 months. Primary outcome measures included the I-PSS, I-PSS quality of life score, maximum urinary flow and post-void residual urine volume. Secondary outcome measures included treatment failure, complications, hospital stay and catheterization time.nnnRESULTSnA total of 82 patients agreed to be randomized to receive laser therapy (38) or transurethral prostatic resection (44). There were significant improvements in all primary outcomes in each group from randomization to followup. Transurethral prostatic resection was significantly better than laser therapy for I-PSS and maximum urinary flow values (p = 0.035 and 0.029, respectively) but there were no differences in post-void residual urine volume and I-PSS quality of life score between the groups. We noted significantly more treatment failures with laser therapy than resection (8 versus 0, p = 0.0014), although only 3 patients required resection after laser therapy because of persistent symptoms. In addition, hospital stay after resection was 2-fold that after laser therapy (ratio of geometric means 2.01, 95% confidence interval 1.54 to 2.61, p <0.0001). However, time to catheter removal was 9 times longer in the laser therapy group (p <0. 0001). Complication rates were significantly higher for transurethral prostatic resection (chi-square 5.05, 1 df, p = 0.025).nnnCONCLUSIONSnTransurethral prostatic resection is more effective than laser ablation in men with chronic urinary retention in terms of symptom score, maximum urinary flow and failure. However, men who underwent resection had significantly more treatment complications and were hospitalized longer than those who received laser therapy. This finding implies that laser ablation therapy may have a role in patients at higher risk who are willing to accept a lower level of effectiveness in exchange for decreased complication rates and hospital stay.

The development and validation of a questionnaire to assess visual symptoms/dysfunction and impact on quality of life in cataract patients: the Visual Symptoms and Quality of life (VSQ) Questionnaire

The aim of the study was to develop a new questionnaire to assess visual symptoms/dysfunction and impact on vision-specific quality of life for those undergoing second eye cataract extraction. Items for the VSQ questionnaire were devised with reference to existing literature and following consultation with eye care experts (n = 18) and interviews with cataract patients (n = 40). Piloting work conducted with 53 patients indicated that the questionnaire was promising, with a high level of internal consistency, low levels of missing data and indications that it was responsive to surgery. A modified version of the questionnaire was completed by 105 patients having received ‘early’ surgery and 103 scheduled for routine surgery within a randomized controlled trial evaluating the effectiveness of second eye cataract surgery. Analyses showed that the internal consistency of both the visual symptoms/dysfunction and quality of life areas was high (Cronbachs alpha 0.82 and 0.83, respectively). Highly significant improvements were found for early surgery patients (p < 0.0001), with little change among routine surgery patients. Two final versions of the VSQ questionnaire have been produced for future use in assessing visual symptoms/dysfunction and impact on vision-specific quality of life: a scoreable short form and more detailed and sensitive long form.

TRANSURETHRAL PROSTATIC RESECTION OR LASER THERAPY FOR MEN WITH ACUTE URINARY RETENTION: THE CLASP RANDOMIZED TRIAL

PURPOSEnTransurethral resection of the prostate is the standard operation for acute urinary retention, although laser prostatectomy is reportedly effective and safe. The ClasP (conservative management, laser, transurethral resection of the prostate) study compared transurethral prostatic resection and noncontact neodymium (Nd):YAG visual laser assisted prostatectomy for treatment of acute urinary retention.nnnMATERIALS AND METHODSnThis study was a multicenter randomized controlled trial, analyses were by intention to treat and followup was at 7.5 months after randomization. Primary outcomes were treatment failure, and included International Prostate Symptom Score, International Prostate Symptom Score quality of life score, residual urine and flow rate. Secondary outcomes included complications, and duration of catheterization and hospitalization.nnnRESULTSnA total of 148 men were randomized to transurethral prostatic resection (74) and laser (74). There were fewer treatment failures after prostatic resection (p = 0.008) and fewer men after resection required secondary surgery for poor results (1 versus 7, p = 0.029). Maximum flow rates after transurethral prostatic resection were better than after laser (mean difference 4.4 ml. per second). Comparison of symptom and quality of life scores demonstrated that any clinically significant advantage for laser could be ruled out. Patients stayed a mean of 2 extra days in the hospital after resection. The duration of catheterization was greater after laser but significantly fewer major treatment complications were found with laser therapy.nnnCONCLUSIONSnTransurethral prostatic resection was more effective, resulted in fewer failures than laser treatment and remains the procedure of choice for men with acute urinary retention.

Transurethral Prostate Resection, Noncontact Laser Therapy or Conservative Management in Men With Symptoms of Benign Prostatic Enlargement? An Economic Evaluation

PURPOSEnWe evaluated the cost-effectiveness of noncontact laser therapy compared with transurethral prostate resection and conservative treatment in men with symptoms associated with benign prostatic enlargement.nnnMATERIALS AND METHODSnA total of 340 men with uncomplicated lower urinary tract symptoms participated in a large multicenter pragmatic randomized trial called the CLasP (Conservative management, Laser therapy, transurethral resection of the Prostate) study. Costs to the United Kingdom National Health Service and patients were determined from the time of randomization to the 7.5-month followup. Incremental cost-effectiveness ratios using conservative management as the base case were calculated for certain trial outcomes, including International Prostate Symptom Score (I-PSS), I-PSS quality of life score, maximum urinary flow, post-void residual urine volume, quality adjusted life-years and a composite measure of success based on I-PSS and maximum urinary flow. One-way sensitivity analysis of the basic costs and incremental cost-effectiveness ratios were done from the NHS viewpoint.nnnRESULTSnMean costs per patient were greatest for noncontact laser therapy and least for conservative management. The incremental cost-effectiveness ratios showed that transurethral prostate resection was more cost-effective than noncontact laser treatment for all primary trial outcomes. The incremental cost-effectiveness ratios of transurethral prostate resection compared with conservative management were pound 81 per unit decrease in the I-PSS score and pound 1,338 per additional successful case per 100 patients. Sensitivity analysis showed that the initial results were robust.nnnCONCLUSIONSnNoncontact laser was the mostly costly treatment option. Transurethral prostate resection was more cost-effective than noncontact laser therapy in terms of symptomatic improvement. In men wishing to delay treatment conservative treatment appears to provide a cost-effective alternative in the short term.

Mortality at ages 50–59 and deprivation at early and late stages of the life course in Wales

Background: Most previous studies have examined the association between mortality and deprivation at only one point in time. However, risk accumulates over the life course. The design of the study was ecological. Its aims were to explain inequalities in total and cause-specific mortality between geographical areas in relation to the lifestyle and health behaviours of the resident populations and the area levels of deprivation in 1981 and in 1921–40. Methods: Data on health behaviour from the 1985 Heartbeat Wales Community Survey were evaluated in light of Welsh mortality rates for the period 1981–99, 1981 census data on socioeconomic position and the infant mortality rates in 1921–40. Negative binomial models were carried out to investigate the district-level association of mortality with deprivation (infant mortality in 1921–40, Carstairs score in 1981, combined index of deprivation) independently from the personal habits and characteristics of the resident population. Results: There was an increased risk of death in deprived areas compared with more wealthy ones. Both infant mortality (a proxy of material deprivation during the time in which the 50–59-year-old individuals were born or were children) and Carstairs scores (a proxy of deprivation during adulthood) were strongly associated with recent mortality. Deprivation had stronger effects in women than in men, the only exception being the effects of later life deprivation on lung cancer. Conclusions: Area characteristics at different points of time may help to explain geographical inequality in mortality.