Percutaneous nephrolithotomy vs retrograde intrarenal surgery for renal stones: a Cochrane Review.

OBJECTIVES: To assess the effects of percutaneous nephrolithotomy (PCNL) vs retrograde intrarenal surgery (RIRS) for the treatment of renal stones in adults. METHODS: We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, three other databases, trials registries, other sources of the grey literature, and conference proceedings up to 23 March 2023. We applied no restrictions on publication language or status. Screening, data extraction, risk-of-bias assessment, and certainty of evidence (CoE) rating using the Grading of Recommendations Assessment, Development and Evaluations (GRADE) approach were done in duplicate by two independent reviewers. This co-publication focuses on the primary outcomes of this review only. RESULTS: We included 42 trials that met the inclusion criteria. Stone-free rate (SFR): PCNL may improve SFRs (risk ratio [RR] 1.13, 95% confidence interval [CI] 1.08-1.18; I2 = 71%; 39 studies, 4088 participants; low CoE). Major complications: PCNL probably has little to no effect on major complications (RR 0.86, 95% CI 0.59-1.25; I2 = 15%; 34 studies, 3649; participants; moderate CoE) compared to RIRS. Need for secondary interventions: PCNL may reduce the need for secondary interventions (RR 0.31, 95% CI 0.17-0.55; I2 = 61%; 21 studies, 2005 participants; low CoE) compared to RIRS. CONCLUSION: Despite shortcomings in most studies that lowered our certainty in the estimates of effect to mostly very low or low, we found that PCNL may improve SFRs and reduce the need for secondary interventions while not impacting major complications. Ureteric stricture rates may be similar compared to RIRS. We expect the findings of this review to be helpful for shared decision-making about management choices for individuals with renal stones.

Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults.

BACKGROUND: Kidney stones (also called renal stones) can be a source of pain, obstruction, and infection. Depending on size, location, composition, and other patient factors, the treatment of kidney stones can involve observation, shock wave lithotripsy, retrograde intrarenal surgery (RIRS; i.e. ureteroscopic approaches), percutaneous nephrolithotomy (PCNL), or a combination of these approaches. OBJECTIVES: To assess the effects of percutaneous nephrolithotomy (PCNL) versus retrograde intrarenal surgery (RIRS) for the treatment of renal stones in adults. SEARCH METHODS: We performed a comprehensive search of the Cochrane Library, MEDLINE, Embase, Scopus, and two trials registries up to 23 March 2023. We applied no restrictions on publication language or status. SELECTION CRITERIA: We included randomized controlled trials that evaluated PCNL (grouped by access size in French gauge [Fr] into three groups: ≥ 24 Fr [standard PCNL], 15-23 Fr [mini-PCNL and minimally invasive PCNL], and < 15 Fr [ultra-mini-, mini-micro-, super-mini-, and micro-PCNL]) versus RIRS. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and extracted data from the included studies. Our primary outcomes were stone-free rate, major complications, and need for secondary interventions. Our main secondary outcomes were unplanned medical visits to emergency/urgent care or outpatient clinic, length of hospital stay, ureteral stricture or injury, and quality of life. We performed statistical analyses using a random-effects model. We rated the certainty of evidence using GRADE criteria. We adopted a minimally contextualized approach with predefined thresholds for minimal clinically important differences (MCIDs). MAIN RESULTS: We included 42 trials assessing the effects of PCNL versus RIRS in 4571 randomized participants. Twenty-two studies were published as full-text articles, and 20 were published as abstract proceedings. The average size of stones ranged from 10.1 mm to 39.1 mm. Most studies did not report sources of funding or conflicts of interest. The main results for the most important outcomes are summarized below. Stone-free rate PCNL compared with RIRS may improve stone-free rates (risk ratio [RR] 1.13, 95% confidence interval [CI] 1.08 to 1.18; I2 = 71%; 39 studies, 4088 participants; low-certainty evidence). Based on 770 participants per 1000 being stone-free with RIRS, this corresponds to 100 more (62 more to 139 more) stone-free participants per 1000 with PCNL (an absolute difference of 10%, where the predefined MCID was 5%). Major complications PCNL compared with RIRS probably has little or no effect on major complications (RR 0.86, 95% CI 0.59 to 1.25; I2 = 15%; 34 studies, 3649 participants; moderate-certainty evidence). Based on 31 complications in the RIRS group, this corresponds to six fewer (13 fewer to six more) major complications per 1000 with PCNL (an absolute difference of 0.6%, where the predefined MCID was 2%). Need for secondary interventions PCNL compared with RIRS may reduce the need for secondary interventions (RR 0.31, 95% CI 0.17 to 0.55; I2 = 61%; 21 studies, 2005 participants; low-certainty evidence). Based on 222 secondary interventions in the RIRS group, this corresponds to 153 fewer (185 fewer to 100 fewer) secondary interventions per 1000 with PCNL (an absolute difference of 15.3%, where the predefined MCID was 5%). Unplanned medical visits No studies reported unplanned medical visits. Length of hospital stay PCNL compared with RIRS may extend length of hospital stay (mean difference 1.04 days more, 95% CI 0.27 more to 1.81 more; I2 = 100%; 26 studies, 2804 participants; low-certainty evidence). This effect size is greater than the predefined MCID of one day. Ureteral stricture or injury PCNL compared with RIRS may have little or no effect on the occurrence of ureteral strictures (RR 0.93, 95% CI 0.39 to 2.21; I2 = 0%; 13 studies, 1574 participants; low-certainty evidence). Based on 14 ureteral strictures in the RIRS group, this corresponds to one fewer (nine fewer to 17 more) ureteral strictures per 1000 with PCNL (an absolute difference of 0.1%, where the predefined MCID was 2%). Quality of life No studies reported quality of life. AUTHORS' CONCLUSIONS: Based on a large body of evidence from 42 trials, we found that PCNL compared with RIRS may improve stone-free rates and may reduce the need for secondary interventions, but probably has little or no effect on major complications. PCNL compared with RIRS may have little or no effect on ureteral stricture rates and may increase length of hospital stay. We found no evidence on unplanned medical visits or participant quality of life. Because of the considerable shortcomings of the included trials, the evidence for most outcomes was of low certainty. Access size for PCNL was less than 24 Fr in most studies that provided this information. We expect the findings of this review to be helpful for shared decision-making about management choices for individuals with renal stones.

Economic Cost and Sustainability of Oral Therapies in Precision Oncology.

PURPOSE: Precision oncology promises improved outcomes but the cost-effectiveness and accessibility of targeted therapies is debatable. We report price change patterns from 2015 to 2019 for several oral anticancer medications for common solid tumor malignancies. METHODS: We collected provider utilization and payment data from the public Medicare Part D database and extracted drug price information for commonly prescribed targeted oral anticancer agents for lung, breast, and prostate cancer. We then calculated median Pearson correlation coefficient values for various drugs (containing more than two data points) within each therapeutic class. We also calculated compound annual growth rates (CAGRs) for medication costs within each class and compared them with the consumer price index (CPI). RESULTS: Our study included six epidermal growth factor receptor inhibitors (EGFRi; one generic), five anaplastic lymphoma kinase inhibitors (ALKi), two B-Raf inhibitors (BRAFi), three hormonal agents (one generic), three cyclin-dependent kinases 4 and 6 inhibitors (CDK4/6i), two poly-ADP-ribose inhibitors (PARPi), and seven antiandrogen agents (two generic). The median (range) Pearson correlation coefficient values for cost of drugs within each therapeutic class were 0.967 (0.915-0.978) for EGFRi, 0.981 (0.966-0.989) for ALKi, 0.996 for BRAFi, 0.994 (0.992-0.999) for CDK4/6i, 0.855 for PARPi, and 0.442 (-0.522 to 0.962) for antiandrogens. Therapies with two or fewer data points (generic erlotinib, dacomitinib, abiraterone, apalutamide, and darolutamide) were excluded. The median CAGRs in costs over the 5-year period were 4.56% (EGFRi), 6.40% (ALKi), 2.58% (BRAFi), 5.48% (hormonal agents), 5.21% (CDK4/6i), 27.29% (PARPi), and 34.8% (antiandrogens). The CPI over 5 years was 2.26%/year, and the average inflation rate was 1.90%/year. CONCLUSION: The median CAGR in costs for modern oral precision-driven cancer therapeutic classes mostly outpaced CPI and the average inflation. Increase in cost within the same class should be weighed against incremental clinical benefit for the patients to ensure that rising costs do not limit access to targeted therapies.

Low Methodological Quality of Systematic Reviews Published in the Urological Literature (2016-2018).

OBJECTIVE: To investigate the methodological quality of systematic reviews (SRs) published in the urological literature. METHODS: PubMed was systematically searched for SRs related to questions of prevention and therapy published in 5 major urology journals (January, 2016 to December, 2018). Two reviewers followed a written a priori protocol to independently screen references in Rayyan and abstract data using a piloted form based on the 16 domains of AMSTAR-2. We performed preplanned statistical hypothesis testing by journal of publication in SPSS version 24.0. RESULTS: Our search identified 260 relevant references, 144 of which ultimately met inclusion criteria. The largest contributors by journal of publication were European Urology (53; 36.8%) followed by Urology (36; 25.0%), and BJU International (24; 16.6%). The most common clinical topics were oncology (64; 44.4%) and voiding dysfunction (32; 22.2%) followed by stones/endourology (14; 9.7%). Just over one-third (52; 36.2%) of reviews had a registered protocol. Nearly all studies (139; 96.5%) searched at least 2 databases. Less than one-third (46; 31.9%) also searched trial registries and one-fifth (30; 20.8%) consulted experts for additional trials. Few studies (14; 10.4%) provided a list of potentially relevant but excluded studies. Only 6 (4.2%) studies met all AMSTAR-2 critical domains as a prerequisite for high-quality reviews. CONCLUSION: A large number of SRs are published in the urological literature each year, yet their quality is suboptimal. There is a need for educating authors, peer reviewers, and editors alike on established standards for high-quality SRs to ensure improvement in the future.