Alexandra C. Maschino

Acupuncture for chronic pain: individual patient data meta-analysis

BACKGROUND Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value. We aimed to determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain. METHODS We conducted a systematic review to identify randomized controlled trials (RCTs) of acupuncture for chronic pain in which allocation concealment was determined unambiguously to be adequate. Individual patient data meta-analyses were conducted using data from 29 of 31 eligible RCTs, with a total of 17 922 patients analyzed. RESULTS In the primary analysis, including all eligible RCTs, acupuncture was superior to both sham and no-acupuncture control for each pain condition (P < .001 for all comparisons). After exclusion of an outlying set of RCTs that strongly favored acupuncture, the effect sizes were similar across pain conditions. Patients receiving acupuncture had less pain, with scores that were 0.23 (95% CI, 0.13-0.33), 0.16 (95% CI, 0.07-0.25), and 0.15 (95% CI, 0.07-0.24) SDs lower than sham controls for back and neck pain, osteoarthritis, and chronic headache, respectively; the effect sizes in comparison to no-acupuncture controls were 0.55 (95% CI, 0.51-0.58), 0.57 (95% CI, 0.50-0.64), and 0.42 (95% CI, 0.37-0.46) SDs. These results were robust to a variety of sensitivity analyses, including those related to publication bias. CONCLUSIONS Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option. Significant differences between true and sham acupuncture indicate that acupuncture is more than a placebo. However, these differences are relatively modest, suggesting that factors in addition to the specific effects of needling are important contributors to the therapeutic effects of acupuncture.

Contemporary Open and Robotic Radical Prostatectomy Practice Patterns Among Urologists in the United States

PURPOSE We describe current trends in robotic and open radical prostatectomy in the United States after examining case logs for American Board of Urology certification. MATERIALS AND METHODS American urologists submit case logs for initial board certification and recertification. We analyzed logs from 2004 to 2010 for trends and used logistic regression to assess the impact of urologist age on robotic radical prostatectomy use. RESULTS A total of 4,709 urologists submitted case logs for certification between 2004 and 2010. Of these logs 3,374 included 1 or more radical prostatectomy cases. Of the urologists 2,413 (72%) reported performing open radical prostatectomy only while 961 (28%) reported 1 or more robotic radical prostatectomies and 308 (9%) reported robotic radical prostatectomy only. During this 7-year period we observed a large increase in the number of urologists who performed robotic radical prostatectomy and a smaller corresponding decrease in those who performed open radical prostatectomy. Only 8% of patients were treated with robotic radical prostatectomy by urologists who were certified in 2004 while 67% underwent that procedure in 2010. Median age of urologists who exclusively performed open radical prostatectomy was 43 years (IQR 38-51) vs 41 (IQR 35-46) for those who performed only robotic radical prostatectomy. CONCLUSIONS While the rate was not as high as the greater than 85% industry estimate, 67% of radical prostatectomies were done robotically among urologists who underwent board certification or recertification in 2010. Total radical prostatectomy volume almost doubled during the study period. These data provide nonindustry based estimates of current radical prostatectomy practice patterns and further our understanding of the evolving surgical treatment of prostate cancer.

Role of Prostate Specific Antigen and Immediate Confirmatory Biopsy in Predicting Progression During Active Surveillance for Low Risk Prostate Cancer

PURPOSE We evaluated predictors of progression after starting active surveillance, especially the role of prostate specific antigen and immediate confirmatory prostate biopsy. MATERIALS AND METHODS A total of 238 men with prostate cancer met active surveillance eligibility criteria and were analyzed for progression with time. Cox proportional hazards regression was used to evaluate predictors of progression. Progression was evaluated using 2 definitions, including no longer meeting 1) full and 2) modified criteria, excluding prostate specific antigen greater than 10 ng/ml as a criterion. RESULTS Using full criteria 61 patients progressed during followup. The 2 and 5-year progression-free probability was 80% and 60%, respectively. With prostate specific antigen included in progression criteria prostate specific antigen at confirmatory biopsy (HR 1.29, 95% CI 1.14-1.46, p <0.0005) and positive confirmatory biopsy (HR 1.75, 95% CI 1.01-3.04, p = 0.047) were independent predictors of progression. Of the 61 cases 34 failed due to increased prostate specific antigen, including only 5 with subsequent progression by biopsy criteria. When prostate specific antigen was excluded from progression criteria, only 32 cases progressed, and 2 and 5-year progression-free probability was 91% and 76%, respectively. Using modified criteria as an end point positive confirmatory biopsy was the only independent predictor of progression (HR 3.16, 95% CI 1.41-7.09, p = 0.005). CONCLUSIONS Active surveillance is feasible in patients with low risk prostate cancer and most patients show little evidence of progression within 5 years. There is no clear justification for treating patients in whom prostate specific antigen increases above 10 ng/ml in the absence of other indications of tumor progression. Patients considering active surveillance should undergo confirmatory biopsy to better assess the risk of progression.

Predictive Value of Four Kallikrein Markers for Pathologically Insignificant Compared With Aggressive Prostate Cancer in Radical Prostatectomy Specimens: Results From the European Randomized Study of Screening for Prostate Cancer Section Rotterdam

BACKGROUND Treatment decisions can be difficult in men with low-risk prostate cancer (PCa). OBJECTIVE To evaluate the ability of a panel of four kallikrein markers in blood-total prostate-specific antigen (PSA), free PSA, intact PSA, and kallikrein-related peptidase 2-to distinguish between pathologically insignificant and aggressive disease on pathologic examination of radical prostatectomy (RP) specimens as well as to calculate the number of avoidable surgeries. DESIGN, SETTING, AND PARTICIPANTS The cohort comprised 392 screened men participating in rounds 1 and 2 of the Rotterdam arm of the European Randomized Study of Screening for Prostate Cancer. Patients were diagnosed with PCa because of an elevated PSA ≥3.0 ng/ml and were treated with RP between 1994 and 2004. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS We calculated the accuracy (area under the curve [AUC]) of statistical models to predict pathologically aggressive PCa (pT3-T4, extracapsular extension, tumor volume >0.5cm(3), or any Gleason grade ≥4) based on clinical predictors (age, stage, PSA, biopsy findings) with and without levels of four kallikrein markers in blood. RESULTS AND LIMITATIONS A total of 261 patients (67%) had significant disease on pathologic evaluation of the RP specimen. While the clinical model had good accuracy in predicting aggressive disease, reflected in a corrected AUC of 0.81, the four kallikrein markers enhanced the base model, with an AUC of 0.84 (p < 0.0005). The model retained its ability in patients with low-risk and very-low-risk disease and in comparison with the Steyerberg nomogram, a published prediction model. Clinical application of the model incorporating the kallikrein markers would reduce rates of surgery by 135 of 1000 patients overall and 110 of 334 patients with pathologically insignificant disease. A limitation of the present study is that clinicians may be hesitant to make recommendations against active treatment on the basis of a statistical model. CONCLUSIONS Our study provided proof of principle that predictions based on levels of four kallikrein markers in blood distinguish between pathologically insignificant and aggressive disease after RP with good accuracy. In the future, clinical use of the model could potentially reduce rates of immediate unnecessary active treatment.

The Surgical Learning Curve for Artificial Urinary Sphincter Procedures Compared to Typical Surgeon Experience

BACKGROUND The artificial urinary sphincter (AUS) is a well-established treatment for male stress urinary incontinence. OBJECTIVE We aimed to characterize the surgical learning curve for reoperation rates after AUS implantation. DESIGN, SETTING, AND PARTICIPANTS The study cohort consisted of 65 602 adult males who received an AUS between 1988 and 2008, constituting close to 90% of all operations conducted during that time. Data on reoperations were obtained from the manufacturer, which requires documentation for warranty coverage. MEASUREMENTS Surgeon experience was calculated as the number of original AUS implants performed prior to the index patients surgery. Multivariable logistic regression models were used to examine the association between experience and reoperative rates, adjusted for case mix. RESULTS AND LIMITATIONS There was a slow but steady decrease in reoperative rates with increasing surgeon experience (p=0.020), showing no plateau through 200 procedures. The risk of reoperation for a surgeon with five prior cases was 24.0%, which decreased to 18.1% for a surgeon with 100 prior implants (absolute risk difference [ARD]: 5.9%; 95% confidence interval [CI], 1.3-10.1%) and to 13.2% for a surgeon with 200 prior implants (ARD: 10.7%; 95% CI, 2.6-16.6%). Two-thirds of contemporary patients (having AUS procedure between years 2000 and 2008) saw a surgeon who had done ≤25 prior AUS implants; only 9% saw a surgeon with ≥100 prior procedures. CONCLUSIONS The learning curve for AUS surgery appears to be very long and without an obvious plateau. This is in contrast to typical surgeon experience, suggesting a considerable burden of avoidable reoperations. Efforts to flatten the learning are urgently needed.

Characteristics of Acupuncture Treatment Associated with Outcome: An Individual Patient Meta-Analysis of 17,922 Patients with Chronic Pain in Randomised Controlled Trials

Background Recent evidence shows that acupuncture is effective for chronic pain. However we do not know whether there are characteristics of acupuncture or acupuncturists that are associated with better or worse outcomes. Methods An existing dataset, developed by the Acupuncture Trialists’ Collaboration, included 29 trials of acupuncture for chronic pain with individual data involving 17,922 patients. The available data on characteristics of acupuncture included style of acupuncture, point prescription, location of needles, use of electrical stimulation and moxibustion, number, frequency and duration of sessions, number of needles used and acupuncturist experience. We used random-effects meta-regression to test the effect of each characteristic on the main effect estimate of pain. Where sufficient patient-level data were available, we conducted patient-level analyses. Results When comparing acupuncture to sham controls, there was little evidence that the effects of acupuncture on pain were modified by any of the acupuncture characteristics evaluated, including style of acupuncture, the number or placement of needles, the number, frequency or duration of sessions, patient-practitioner interactions and the experience of the acupuncturist. When comparing acupuncture to non-acupuncture controls, there was little evidence that these characteristics modified the effect of acupuncture, except better pain outcomes were observed when more needles were used (p=0.010) and, from patient level analysis involving a sub-set of five trials, when a higher number of acupuncture treatment sessions were provided (p<0.001). Conclusion There was little evidence that different characteristics of acupuncture or acupuncturists modified the effect of treatment on pain outcomes. Increased number of needles and more sessions appear to be associated with better outcomes when comparing acupuncture to non-acupuncture controls, suggesting that dose is important. Potential confounders include differences in control group and sample size between trials. Trials to evaluate potentially small differences in outcome associated with different acupuncture characteristics are likely to require large sample sizes.

Long‐term follow‐up of 3‐month neoadjuvant hormone therapy before radical prostatectomy in a randomized trial

Study Type – Therapy (RCT)
Level of Evidence 1b

Changes in Pelvic Organ Prolapse Surgery in the Last Decade among United States Urologists

PURPOSE Surgical correction of pelvic organ prolapse underwent transformation in the last decade. Training in pelvic organ prolapse surgery, the ease of mesh kit use, and Food and Drug Administration warnings about mesh have influenced practice patterns. We investigated trends in pelvic organ prolapse procedures. MATERIALS AND METHODS Case logs of pelvic organ prolapse procedures, mesh use and pessary placement were obtained from the American Board of Urology for 2003 to 2012. We evaluated associations between surgeon characteristics and the use of pelvic organ prolapse procedures. RESULTS Of 6,355 nonpediatric urologists applying for certification or recertification 2,192, representing a 10% annual sample of all urologists, reported performing pelvic organ prolapse procedures during the study period. The number of procedures increased steadily from 930 in 2003 to 6,978 in 2012. The number of colporrhaphies increased from 806 to 2,670 and the number of colpopexies increased from 32 to 1,414 between 2003 and 2012. The number of vaginal colpopexies increased from 24 to 1,016 during the study period. The number of sacrocolpopexies increased from 8 to 398 with exponential increases in laparoscopic sacrocolpopexy (282 cases by 2012). Mesh insertion increased from 10 cases reported by applicants in 2005 to 1,552 reported in 2012 (p <0.0005). Mesh revision, first reported in 2007 with 52 performed, consistently increased to 214 in 2012. Urologists trained in female urology performed a median of 16 pelvic organ prolapse procedures, double the number reported by surgeons trained in other urological fellowships. Urologists of the female gender also reported performing approximately 8 more procedures annually than male urologists. CONCLUSIONS The number of pelvic organ prolapse operations done by urologists increased dramatically in the last decade with a similar increase in mesh use. More colpopexies are now performed with laparoscopic sacrocolpopexy showing an exponential increase. The recent trend of mesh revision is notable with a much faster rate of increase than mesh insertion.

Comparative Outcomes of Pure Squamous Cell Carcinoma and Urothelial Carcinoma With Squamous Differentiation in Patients Treated With Radical Cystectomy

PURPOSE We compared clinical outcomes, and identified predictors of cancer specific and overall survival after radical cystectomy in patients with urothelial carcinoma with squamous differentiation and those with pure squamous cell carcinoma. MATERIALS AND METHODS We reviewed data on 2,031 patients treated with radical cystectomy and pelvic lymph node dissection at a single high volume referral center. Of these patients 78 had squamous cell carcinoma and 67 had squamous differentiation. Survival estimates by histological subtype were described using Kaplan-Meier methods. Within histological subtypes pathological stage, nodal invasion, soft tissue margins, age and gender were evaluated as predictors of cancer specific survival and overall survival using univariate Cox regression. RESULTS Median followup was 44 months. Of 104 patient deaths 60 died of their disease. We did not find a statistically significant difference between survival curves of patients with squamous cell carcinoma and squamous differentiation (log rank overall survival p = 0.6, cancer specific survival p = 0.17). Positive soft tissue margins were associated with worse cancer specific survival (HR 6.92, 95% CI 2.98-16.10, p ≤0.0005) and overall survival (HR 3.68, 95% CI 1.84-7.35, p ≤0.0005) in patients with pure squamous cell carcinoma. Among patients with squamous differentiation, pelvic lymphadenopathy was associated with decreased overall survival (HR 2.52, 95% CI 1.33-4.77, p = 0.004) and cancer specific survival (HR 3.23, 95% CI 1.57-6.67, p = 0.002). CONCLUSIONS There appears to be no evidence of a difference in cancer specific survival or overall survival between patients with squamous cell carcinoma and those with squamous differentiation treated with radical cystectomy and pelvic lymph node dissection. Patients with squamous differentiation and tumor metastases to pelvic lymph nodes should be followed more closely, and adjuvant treatment should be considered to improve survival. Wide surgical resection is critical to achieve local tumor control and improve survival in patients with squamous cell carcinoma.

Midurethral sling is the dominant procedure for female stress urinary incontinence: analysis of case logs from certifying American Urologists.

OBJECTIVE To investigate contemporary trends in the use of midurethral sling procedures for the surgical correction of female stress urinary incontinence over the past decade. METHODS Annualized case log data for female incontinence surgeries from certifying and recertifying urologists were obtained from the American Board of Urology. Descriptive analysis of the number and type of cases per year was performed. Associations between surgeon characteristics and the use of female incontinence procedures were evaluated. RESULTS A total of 6355 nonpediatric urologists applied for certification or recertification between 2003 and 2012. Two-thirds (4185) reported performing any procedures for female incontinence. Procedures sharply increased from 4632 in 2003 to 7548 in 2004, then remained relatively stable between 2005 and 2012 (range, 8014-10,238 cases). Traditional procedures decreased from 17% of female incontinence procedures in 2003 to 5% in 2004 to <1% since 2010 (P <.0005). Midurethral sling procedures have risen sharply from 3210 procedures in 2003 to 7200 in 2012 (P <.0005). Endoscopic injection treatments have remained stable. CONCLUSION Midurethral slings have been widely adopted by urologists over the last decade. Increase in sling usage coincided with a drastic decline in traditional repairs, implying that the newer midurethral slings were replacing these traditional procedures for the treatment of female incontinence. In addition, the fact that the use of periurethral injections did not change significantly during this time period indicates that increased sling usage is responsible for most of the decline in traditional repairs.