Urinary Stones and Intervention Quality of Life (USIQoL): Development and Validation of a New Core Universal Patient-reported Outcome Measure for Urinary Calculi.

BACKGROUND: Urolithiasis has a significant impact on patients' health-related quality of life (HRQoL). OBJECTIVE: To develop a core patient-reported outcome measure (PROM) using modern psychometric methods to quantify the impact of urolithiasis and different treatments. DESIGN, SETTING, AND PARTICIPANTS: Adult patients with urinary calculi, attending urology departments, covering all index categories and treatment spectrum, participated during different development phases. The pilot instrument was created from potential items (phases 1 and 2) within the conceptual framework. The instrument was pretested (phase 3) and then underwent psychometric evaluation in two parts (phases 4 and 5). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The validity and reliability of the new PROM were assessed using Rasch measurement theory (RUMM 2030 statistical software) and traditional analyses. RESULTS AND LIMITATIONS: In total, 683 patients (median age 51 yr, range 18-92 yr) participated during different phases. The initial 60-item draft (five scales) was completed by 212 patients (phase 4). A revised 25-item draft was produced after removal of unstable items. In the second field test, the revised version was evaluated by 369 patients. This led to the final Urinary Stones and Intervention Quality of Life (USIQoL; 15 items) with summated logit scores. The PROM includes three scales: pain with physical health (six items), psychosocial health (seven items) and work performance (two items). Lower scores indicate better outcomes. Results demonstrate that USIQoL is reliable (r ≥ 0.8) and internally consistent (α ≥ 0.7), and has good construct validity (good hypothesised correlations, r > 0.3) and satisfactory sensitivity to change (p < 0.01). All scales demonstrated unidimensionality with good item fit and person separation indices. A limitation is that USIQoL was developed in the English language within the UK population. CONCLUSIONS: USIQoL is a short, unidimensional, valid, and reliable PROM for assessing the HRQoL impact of urinary calculi and treatments. It is expected to serve as a core PROM across the entire spectrum of urolithiasis. PATIENT SUMMARY: Kidney stones are a common condition for which various treatment options are available. The condition and treatments have a significant impact on a patient's quality of life. This can be measured objectively using a valid and reliable patient-reported outcome measure (PROM) developed using modern methods. We have developed a PROM that provides helpful and accurate measurement useful for all stakeholders.

Capturing the non-technical skills of a technical skills trainer (NTS-TeST) during simulation.

OBJECTIVE: To develop an assessment instrument that can be used as a comprehensive feedback record to convey to a trainer the non-technical aspects of skill acquisition and training. METHODS: The instrument was developed across three rounds. In Round 1, 6 endourological consultants undertook a modified Delphi process. Round 2 included 10 trainers who assessed each question's relevance and practicability. Round 3 involved a pilot study with fifteen urology residents who participated in a technical skills simulation session with the incorporation of the instrument. We report the content, face, and construct validity, and the internal consistency of an NTS instrument for trainers. RESULTS: The instrument had a consistent and a high positive average for each of the 4 sections of the instrument, regardless of the type of user. Positive Spearman's correlation coefficients (0.02 to .64) for content validity and Cronbach's alpha (a = 0.70) indicated good validity and moderate reliability of the instrument. CONCLUSION: We propose a novel NTS instrument for trainers during a simulation. This instrument can be used for benchmarking the quality of technical skills simulation training.

An Update on Evaluation and Management in Cystinuria.

Cystinuria is the most common cause of inherited stone disease and is caused by the failure of absorption of filtered dibasic amino acids including cystine in the proximal tubules. It is associated with a very high recurrence rate in affected patients, with the potential for significant morbidity in such patients due to the need for repeated surgical interventions. A multimodal and multispecialty approach in a dedicated centre is the key to improving treatment outcomes and patient adherence to the treatment. This article reviews the latest knowledge on the clinical and diagnostic features and summarises key developments to aid clinicians in diagnosis and management options, together with future directions for the care of these patients.

Antibiotic use and the prevention and management of infectious complications in stone disease.

The importance of assessing perioperative urine/stone cultures and providing appropriate antibiotic prophylaxis prior to shock wave lithotripsy (SWL) or endoscopic intervention cannot be minimized. Urinary tract infection (UTI) is the most common complication relating to stone intervention. Adequate assessment of culture data and adherence to appropriate guidelines may prevent the development of UTI and the potential for post-intervention urosepsis. This review outlines the current evidence for prophylaxis in the prevention of UTI and urosepsis, as well as the interpretation of stone culture data to provide an evidence-based approach for the judicious use of antibiotics in urologic stone practice.

Radiofrequency ablation (RFA) of renal cell carcinoma (RCC): experience in 200 tumours.

OBJECTIVES: To evaluate our clinical experience with percutaneous image-guided radiofrequency ablation (RFA) of 200 renal tumours in a large tertiary referral university institution. PATIENTS AND METHODS: Image-guided RFA (ultrasonography or computed tomography [CT]) of 200 renal tumours in 165 patients from June 2004 to 2012 was prospectively evaluated. Institutional Review Board approval was granted. The treatment response and technical success were defined by absence of contrast enhancement within the tumour on contrast enhanced CT or magnetic resonance imaging. Both major and minor complications, glomerular filtration rate (GFR) before and after RFA, the management and outcomes of the complications, as well as oncological outcome were prospectively documented. Multivariate analysis was used to determine variables associated with major complications and also the percentage GFR change after RFA. The overall (OS), 5-year cancer-specific (CSS), local recurrence-free (LRFS) and metastasis-free survival (MFS) rates are presented using the Kaplan-Meier curves. RESULTS: In all, 200 tumours were RF ablated with a mean (range) tumour size of 2.9 (1-5.6) cm and the mean (range) patient age was 67.7 (21-88.6) years with a mean follow-up period of 46.1 months. The primary technical and overall technical success rate was 95.5% and 98.5%, respectively. Two independent predictors of successful RFA in a single sitting were tumour size (<3 cm) and exophytic location in multivariate logistic regression analysis. Major complications included ureteric injury (six patients), calyceal-cutaneous fistula (one), acute tubular necrosis (one) and abscess (two). Two independent predictors of ureteric injury were central location and lower pole position. Within this cohort of patients, only four patients developed significant renal function deterioration i.e. >25% decreased in GFR. In all, 161 (98%) patients of the 165 patients have preservation of renal function. Any change in renal function after RFA was not influenced by tumour factors or solitary kidney status. In our clinical series, this yielded a 5-year OS, CSS, LRFS and MFS rates of 75.8%, 97.9%, 93.5% and 87.7% respectively. CONCLUSIONS: Image-guided RFA is a safe, nephron sparing and effective treatment for small renal cell carcinoma (RCC) tumours with a low rate of recurrence and has good 5-year CSS and MFS rates.

Assessment of Clavien-Dindo classification in patients >75 years undergoing nephrectomy/nephroureterectomy.

INTRODUCTION: There is a paucity of a standardized post-operative complications grading system in urology especially in the elderly population. Studies show satisfactory survival and oncological outcomes albeit with a slight increase in post-operative morbidity compared to younger patients. The Clavien-Dindo classification for post-operative complications is established as a valid system worldwide and applicable in many fields of surgery. PURPOSE: Retrospective assessment of post-operative complications in patients >75 years who underwent open/laparoscopic nephrectomy/nephroureterectomy for renal diseases and grading the post-operative complications according to the Clavien-Dindo classification. MATERIALS AND METHODS: Retrospective review of case notes was performed in patients >75 years who underwent a laparoscopic/open nephrectomy/nephroureterectomy between 2000 and 2008. Post-operative complications were graded according to the Clavien-Dindo classification. RESULTS: A total of 54 patients >75 years underwent nephrectomy/nephroureterectomy. 29 patients had laparoscopy and 25 had open surgery. Fifty one patients had a malignancy and 3 had benign diseases. Grade I, II, IIIa, IIIb and IVa were 25.6%, 41.1%, 7.7%, 7.7% and 17.9% respectively. No significant difference was noted in the 2 groups. CONCLUSIONS: We believe that in elderly patients, laparoscopic surgery can be offered safely without significantly increasing the surgical risks. The Clavien-Dindo classification is easy to use and effectively applied to categorize post-operative complications associated with nephrectomy/nephroureterectomy in elderly population. However, this system needs slight modification to incorporate intra-operative complications and large studies are needed to validate and standardize this classification for all urological procedures.

Minimally invasive surgical options for ureteropelvic junction obstruction: A significant step in the right direction.

Open pyeloplasty is the gold standard treatment for adult ureteropelvic junction obstruction (UPJO) with published success rates consistently over 90%. In recent years, the management of UPJO has been revolutionized by the introduction of endoscopic procedures and laparoscopic techniques. We analyzed the long-term results of endoscopic and other minimal access approaches for the treatment of UPJO.Early results for endopyelotomy were promising but long-term results were not encouraging. Laparoscopic pyeloplasty technique is well defined and duplicates the surgical principles of conventional open pyeloplasty. With such a large variety of minimally invasive procedures for the treatment of UPJO available, the treatment choice for UPJO must be based on the success and morbidity of the procedures, the surgeon's experience, the cost of the treatment, and the patient's choice. We feel that with the technological advances in instrumentation coupled with a decrease in cost and improved training of urological surgeons, laparoscopic pyeloplasty may evolve to be the new "gold" standard for the treatment of UPJO.

Updates in endourology.

Rapid urologic innovations in minimally invasive treatment are creating exciting new horizons in endourology. However, these new concepts are blurring the traditional boundary between endourology and oncology. Organ-sparing surgery, laparoscopy, robotics systems, and image-guided ablation techniques enable surgeons to develop specifically tailored treatments for patients. We examine recent developments and future prospects for how new technology will continue to advance the field of endourology.

The British Association of Urological Surgeons: guidelines for training in laparoscopy.

OBJECTIVE: To report the guidelines of the British Association of Urological Surgeons (BAUS), commissioned by the National Institute for Health and Clinical Excellence (NICE) in response to safety concerns about the rapid uptake of new, complex laparoscopic procedures. METHODS: A combination of expert opinion and review of published studies was used to produce a consensus document. RESULTS: Patient demand and excellent published reports have prompted many consultant urologists with little previous laparoscopic training to learn laparoscopic procedures. Laparoscopic urological surgery involves some of the most complex procedures in all of surgery and there has been a lack of formal training for consultants. The guidelines produced by BAUS are designed to help consultant urologists gain experience safely, by a combination of didactic learning and mentorship. We recommend that urologists work with a mentor and master ablative laparoscopic surgery before attempting more complex procedures such as prostatectomy, cystectomy, pyeloplasty and partial nephrectomy. These guidelines were approved by BAUS Council in October 2006. CONCLUSIONS: These guidelines are intended to be complementary to the NICE guidelines on specific procedures (available at http://www.nice.org.uk).

Limitations of extracorporeal shock wave lithotripsy.

PURPOSE OF REVIEW: Extracorporeal shock wave lithotripsy (ESWL) is the preferred modality for the treatment of renal and upper ureteric calculi. The present review focuses on the limitations of ESWL, where recent developments have tried to identify patients who are unlikely to succeed with ESWL and where improvements in shock wave delivery may increase successful stone fragmentation. RECENT FINDINGS: Evaluation of patients prior to ESWL is especially important, and the use of imaging in the decision process, with the use of computed tomography attenuation values and skin-to-stone distance, can help improve our ability to identify suitable patients for shock wave treatment. Continued research into the methods of shock wave delivery techniques and lithotripter designs will help achieve better stone fragmentation rates with reduced side effects. SUMMARY: The importance of traditional factors in predicting ESWL success, such as stone size, location, composition and renal anatomy, are well known. More recently, authors have created nomograms to predict stone-free outcome after ESWL. Others have used the information obtained from computed tomography to predict stone comminution. In addition, modifications in shock wave delivery by altering shock rate and voltage have been researched in an effort to improve shock wave efficacy.

Management of stones in neurological patients.

PURPOSE OF REVIEW: Patients with neurological disorders and urinary stone disease pose a significant challenge to the urologist, and possibly as a consequence, the literature is sparse about this small but important group of patients who are at an increased risk of urolithiasis, complications following surgical intervention and stone recurrence. Thus, this review has included publications from the last 5 years. RECENT FINDINGS: In the last few years several studies have reported the challenge for getting these patients stone-free and highlighted the risk management issues that need to be covered when considering surgical intervention. Similarly, these patients are at increased risk of stone recurrence and the published literature illustrates the need for consistent posttreatment regimens to minimize further stone formation--an area which presents great opportunities for research. All the publications emphasize the need for these patients to be assessed in dedicated stone centres with access to all the various modalities for treatment. SUMMARY: Patients with spinal neuropathy and urolithiasis pose a significant operative challenge, and there needs to be an established set of evidence-based guidelines to assist medical decision making for this high-risk population group. Unfortunately, the evidence to date is weak and more work is necessary to provide the basis for improving patient care.

Challenge of percutaneous nephrolithotomy in patients with spinal neuropathy.

OBJECTIVE: To assess the technical difficulties, associated complications and stone clearance rates in patients with spinal neuropathy undergoing percutaneous nephrolithotomy. METHODS: Twenty-nine patients with spinal neuropathy underwent percutaneous nephrolithotomy in the two centers studied between October 1995 and January 2002. They were nine patients with traumatic spinal cord injury, 10 patients with spina bifida and 10 with other heterogeneous causes for their spinal neuropathy. The group included 12 men and 17 women, with an average age of 44 years (14-80). Patients' medical records were reviewed retrospectively for data relating to their renal lithiasis. RESULTS: A total of 39 percutaneous nephrolithotomy procedures were undertaken on 32 kidneys. Thirteen procedures were for staghorn calculi. Preoperatively, eight kidneys required nephrostomy and 5 J stent decompression. The average American Society of Anesthesiologists (ASA) score was 3, and one patient had percutaneous nephrolithotomy performed under local anaesthetic as the risk of general anaesthetic was felt to be too high. The associated morbidity and mortality in this group is significant. There were two postoperative deaths. Major complications were associated with three procedures, and consisted of seizures, aspiration pneumonia and pressure necrosis. Nine patients experienced minor complications including fever, hypotension and nephrostomy site leakage. Nine patients required intensive therapy unit care postoperatively and the average hospital stay for the group was 13.32 days. Only 18 (62%) patients were rendered stone-free from their initial percutaneous nephrolithotomy. Seven patients required a further procedure for stone clearance: four underwent extracorporeal shock-wave lithotripsy, two ureteroscopy and one nephrectomy. CONCLUSIONS: Patients with spinal neuropathy and renal lithiasis pose a significant operative challenge. Technical difficulties and potential complications should be considered carefully before undertaking percutaneous nephrolithotomy in these patients.

Intrinsic chemotherapy resistance to the tubulin-binding antimitotic agents in renal cell carcinoma.

Renal cancer is one of the most chemoresistant tumor types. Using a panel of 10 established renal cancer cell lines that have not been subjected to prior drug selection, the range of functional resistance phenotypes to the tubulin-binding agents paclitaxel, vinblastine, vincristine and patupilone (epothilone B, EPO906) was determined, together with expression of P-glycoprotein (PgP), multidrug resistance associated protein-2 (MRP2) and major vault protein (MVP) proteins. The IC(50) values for vincristine correlated positively with PgP expression (r = 0.73; p = 0.031), with values for paclitaxel and vinblastine just failing to reach significance. A significant positive correlation was observed for sensitivity to paclitaxel and MRP2 expression only (r = 0.8; p = 0.013). MVP expression did not correlate with sensitivity to any of the drugs examined. All cell lines exhibited much greater sensitivity to patupilone, demonstrating for the first time the potential use of patupilone in this cancer. In tissue samples from chemotherapy-naive renal cell carcinoma (RCC) patients, marked downregulation or absence of PgP in many tumor cells with expression levels more similar to sensitive cell lines rather than the resistant lines was seen. Similarly, MRP2 was absent or only weakly present in tumor cells, whereas MVP was very strongly upregulated in most tumor samples. This study illustrating discrepancies between results exclusively based on studies in cell lines and findings in vivo suggests that the role of PgP and MRP2 in intrinsic resistance in RCC in vivo may be less than expected from the in vitro findings and supports a potential role for MVP on the basis of in vivo expression studies.