Penile allotransplantation for penis amputation following ritual circumcision: a case report with 24 months of follow-up.

INTRODUCTION: Ritual circumcision complicated by gangrene is a leading cause of penile loss in young men in South Africa. This deeply rooted cultural tradition is unlikely to be abolished. Conventional reconstructive techniques using free vascularised tissue flaps with penile implants are undesirable in this often socioeconomically challenged group because donor site morbidity can hinder manual labour and vigorous sexual activity might lead to penile implant extrusion. The psychosociological effects of penile loss in a young man are devastating and replacing it with the same organ is likely to produce the maximum benefit. METHODS: We first performed a cadaver-to-cadaver penile transplantation as preparation. After approval from the Human Research Ethics Committee was obtained, we recruited potential recipients. We screened the potential participants for both physical and psychological characteristics, including penile stump length, and emotional suitability for the procedure. A suitable donor became available and the penis was harvested. We surgically prepared the penile stump of the recipient and attached the penile graft. Immunosuppression treatment with antithymyocyte globulin, methylprednisolone, tacrolimus, mycophenolate mofetil, and prednisone were commenced. Tadalafil at 5 mg once per day was commenced after 1 week as penile rehabilitation and was continued for 3 months. We collected on quality-of-life scores (Short Form 36 version 2 [SF-36v2] questionnaires) before surgery and during follow-up and measured erectile function (International Index for Erectile Function [IIEF] score) and urine flow rates at 24 months post transplant. FINDINGS: The warm ischaemia time for the graft after removal was 4 min and the cold ischaemia time was 16 h. The surgery lasted 9 h. An arterial thrombus required urgent revision 8 h after the operation. On post operative day 6, an infected haematoma and an area of proximal skin necrosis were surgically treated. The recipient was discharged after 1 month and first reported satisfactory sexual intercourse 1 week later (despite advice to the contrary). The recipient reported regular sexual intercourse from 3 months after the operation. An episode of acute kidney injury at 7 months was reversed by reducing the tacrolimus dose to 14 mg twice per day. At 8 months after surgery, the patient had a skin infection with phaeohyphomycosis due to Alternaria alternata, which we treated with topical antifungal medication. Quality-of-life scores improved substantially after the operation (SF-36v2 mental health scores improved from 25 preoperatively, to 57 at 6 months and 46 at 24 months post transplant; physical health scores improved from 37 at baseline to 60 at 6 months and 59 at 24 months post-transplant). At 24 months, measured maximum urine flow rate (16·3 mL/s from a volume voided of 109 mL) and IIEF score (overall satisfaction score of 8 from a maximum of 10) were normal, showing normal voiding and erectile function, respectively. INTERPRETATION: Penile transplantation restored normal physiological functions in this transplant recipient without major complications in the first 24 months. FUNDING: Department of Health, Western Cape Government.

The 1-year decline in estimated glomerular filtration rate (eGFR) after radical nephrectomy in patients with renal masses and matched living kidney donors is the same.

OBJECTIVES: To determine short-term differences in renal function evolution between patients with renal cell carcinoma (RCC) submitted to radical nephrectomy (RN) and living kidney donors matched for age and gender. To assess the role of co-morbidity as a risk factor for developing an estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m(2) . PATIENTS AND METHODS: In this retrospective study patients undergoing Radical Nefrectomy (RN) between January 2000 and February 2011 for suspicion of localised RCC were matched by age and gender to living kidney donors. Renal function was compared between the groups using the Modification in Diet and Renal Disease (MDRD) equation at 1 year after RN. Charlson co-morbidity score, incidence of hypertension, diabetes and cardiovascular disease were compared and assessed as predictors for developing an eGFR of <60 mL/min/1.73 m(2) . RESULTS: In all, 196 patients were included, 98 in each group. The mean age was respectively 60.6 (RCC group) and 59.1 years (donors). The 1-year postoperative mean eGFR (available in 89 patients with RCC and 87 donors) was similar, at a mean (sd) of 56.7 (16.4) mL/min/1.73 m(2) in patients with RCC and 56.2 (9.8) mL/min/1.73 m(2) in donors (P = 0.83). In patients with RCC the incidence and severity of co-morbidities was significantly higher. A preoperative eGFR of 60-89 mL/min/1.73 m(2) was the only independent risk factor for developing a postoperative eGFR of <60 mL/min/1.73 m(2) (odds ratio 4.4, confidence interval 2.1-9.5, P < 0.001, 95% confidence interval). CONCLUSIONS: In our cohorts with advanced age the 1-year follow-up eGFR was similar in both groups. Despite increased co-morbidity in the RCC group there was no increased decline in renal function. Only reduced preoperative eGFR could be identified as risk factor for developing a postoperative eGFR of <60 mL/min/1.73 m(2) .

Co-prescription of gastroprotective agents and their efficacy in elderly patients taking nonsteroidal anti-inflammatory drugs: a systematic review of observational studies.

BACKGROUND & AIMS: Guidelines recommend prescribing gastroprotective agents (proton pump inhibitors, misoprostol) to older patients (primarily ≥65 years old) taking nonsteroidal anti-inflammatory drugs (NSAIDs) to prevent gastrointestinal ulcers. Older individuals are underrepresented in clinical trials of these agents. We systematically reviewed evidence from observational studies on the use of gastroprotective agents in elderly patients and their ability to prevent NSAID-related ulcers in this population. METHODS: We performed a systematic search of Embase and MEDLINE and identified 23 observational studies that focused on elderly patients and reported data on co-prescription of gastroprotective agents and NSAIDs and/or the effectiveness of the agents in preventing gastrointestinal events in NSAID users. We collected data on rates of co-prescription and NSAID-related gastrointestinal events in patients with and without gastroprotection. RESULTS: A median of 24% (range, 10%-69%) of elderly patients taking NSAIDs received a co-prescription for gastroprotective agents; this percentage was only slightly higher in the oldest age groups. All studies of efficacy showed a positive effect of gastroprotection. However, the adjusted results were not suitable for synthesis, and the 5 studies reporting unadjusted results were too heterogeneous for meta-analysis (I(2) = 97%). The studies differed in outcomes, definitions of co-prescription, and differences in baseline risk factors between patients with and without gastroprotection. None of the studies assessed adverse effects of gastroprotective agents. The 2 cost-effectiveness studies reached opposing conclusions. CONCLUSIONS: In a systematic review, the observational evidence for the efficacy of gastroprotective agents in preventing NSAID-associated gastrointestinal events was in agreement with results of randomized controlled trials. However, because of heterogeneity of included studies, it is not clear what the effect would be if more patients were treated, or at what age gastroprotection should be recommended. We offer suggestions to facilitate comparison with other work and address the questions of risk and benefit in relation to age.

A nephrolithometric nomogram to predict treatment success of percutaneous nephrolithotomy.

PURPOSE: Imaging is routinely done preoperatively and postoperatively to assess patients treated with percutaneous nephrolithotomy. We developed a nomogram for percutaneous nephrolithotomy success. MATERIALS AND METHODS: From November 2007 to December 2009 the CROES (Clinical Research Office of the Endourological Society) collected data on consecutive patients at 96 centers globally. Patients were evaluated for stone-free status using plain x-ray of the kidneys, ureters and bladder. Treatment success was defined as no visible stones or residual fragments less than 4 mm. Multivariate regression was used to model the relationship between preoperative descriptors and the stone-free rate. Variables included case load, prior treatment, body mass index, staghorn stones, renal anomalies, and stone burden, location and count. Bootstrapping techniques were used to validate the model. Adjusted chi-square statistic values were used to rank the prognostic value of variables. A nomogram was developed using significant predictors from the model. We assessed the predictive accuracy of the nomogram using the ROC curve AUC. The nomogram was calibrated. RESULTS: Stone burden was the best predictor of the stone-free rate (chi-square = 30.27, p <0.001). Other factors associated with the stone-free rate were case volume (chi-square = 35.75, p <0.001), prior stone treatment (chi-square = 14.55, p <0.012), staghorn stone (adjusted chi-square = 4.73, p <0.029), stone location (chi-square = 14.74, p <0.001) and stone count (chi-square = 4.78, p <0.004). A nephrolithometric nomogram was developed with predictive accuracy (AUC 0.76). CONCLUSIONS: The percutaneous nephrolithotomy stone-free rate can be predicted using preclinical data and radiological information. We present a nephrolithometric nomogram for percutaneous nephrolithotomy.

Age and gender related differences in renal cell carcinoma in a European cohort.

PURPOSE: We evaluated the influence of age on gender related differences in the renal cell carcinoma presentation of patients operated on between 1995 and 2005 in a European country. We also assessed the trend of missing pathological data. MATERIALS AND METHODS: Data on all patients who underwent radical or partial nephrectomy for renal cell carcinoma during 1995 to 2005 in The Netherlands were retrospectively collected from the prospective PALGA (Pathological Anatomical National Automated Archive) database. Patients were divided into 5 cohorts based on age at surgery, including 40 or less, 41 to 50, 51 to 60, 61 to 70 and greater than 70 years. Variables evaluated were gender differences by age, and tumor size, subtype, stage and Fuhrman grade. RESULTS: A higher mean age in women was only observed in those older than 70 years (p <0.001). The male-to-female ratio was 2:1 at ages 41 to 60 years and 1.2:1 at greater than 70 years. Compared to men women had smaller tumors at ages 51 to 60 years (p = 0.03), stage pT3 was less common at age 41 years or greater (p = 0.02), and grade 2 was less common at age 61 years or greater (p <0.001). The incidence of tumors with missing data on stage (14.9%), subtype (52.2%) and grade (47.1%) decreased substantially during the study period (p <0.001). CONCLUSIONS: Older age in women than in men who present to surgery for RCC was only prevalent in those older than 70 years. The male-to-female ratio was almost equal in patients older than 70 years compared to a 2:1 ratio at ages 41 to 60 years. Women presented with fewer pT3 tumors than men at age 41 years or greater. Missing pathological data decreased significantly between 1995 and 2005.

Partial nephrectomy: is there an advantage of the self-retaining barbed suture in the perioperative period? A matched case-control comparison.

OBJECTIVE: To evaluate the efficacy of the self-retaining barbed suture (SRBS) in renal defect repair during partial nephrectomy (PN), by assessing perioperative outcomes. METHODS: From June 2010 on we have been using the SRBS for superficial layer closure during open and laparoscopic PN in two European centers. These data were collected prospectively and matched with historical PN cases performed with conventional suture. Cases were matched for PADUA score, surgical approach (laparoscopic or open) and the center where surgery was performed. Comparisons were made in patient characteristics and perioperative outcomes including warm ischemia time (WIT), changes in hemoglobin (Hb), changes in estimated glomerular filtration rate (eGFR) and perioperative complications between the SRBS and non-SRBS groups. Statistical tests of significance were performed using Student's t test and chi-square test for continuous and categorical variables, respectively. RESULTS: Thirty-one consecutive cases of PN under WIT were performed with SRBS. These cases were matched with cases from the historical database of PN performed with conventional suture. The rate of perioperative complications was statistically significantly lower in the SRBS cohort (6.5 vs. 22.6 %, p = 0.038). Mean ischemia time was 19.6 min (SD, 7.5) in the SRBS group versus 21.8 min (SD, 9.5) in the conventional suture group (p = 0.312). There were no significant differences between groups for postoperative changes in creatinine, eGFR and Hb. Limitations of this study include the absence of randomization and the relative small sample size. CONCLUSIONS: SRBS can be safely used during partial nephrectomy. SRBS reduces significantly the number of perioperative complications.

Application of the logical elements rule method for formalization of clinical rules: case study of ACOVE-NLI.

The Logical Elements Rule Method (LERM) is a step-wise method for formalizing if-then clinical rules. We applied LERM to a set of 40 clinical rules used in pharmacological quality assessment initiatives to assess (1) the amenability of the rules to formalization for decision support application (2) comparing adherence to rules that can and cannot be formalized, and (3) the usefulness of LERM as a tool for this task. Five rules could not be formalized, all due to unclear decision criteria. The adherence to ambiguous, non-formalizable rules was significantly lower than for formalizable ones (<0.001). We modified LERM with three additions for this task: (a) adding the sub-step of restating the rules in a consistent natural-language grammar before decomposing them into normal form, (b) creating rules to use in lieu of a controlled vocabulary, and (c) adding the requirement that a time frame must be defined for all medications (before hospitalization, current medication, new medication, or discharge medication). Although the clinical rules in this sample are all stated as semi-structured if-then recommendations and are used in quality assessment initiatives, many ambiguities and inconsistencies in the clinical rules were identified by using LERM.

Firearm injuries in Nairobi, Kenya: who pays the price?

Because firearm injuries affect the health and social fabric of Kenya, we investigated the problem in collaboration with Kenya's affiliate of International Physicians for the Prevention of Nuclear War. This public health problem has its roots in the civil strife and prevalence of small arms and light weapons in the Horn of Africa. We studied persons with firearm injuries who reached Kenyatta National Hospital in Nairobi during a 6-month period in 2006. We describe their demographic characteristics and speculate that many people injured with guns die before they reach the hospital. The people of Nairobi would benefit from better pre-hospital care, including ambulance transportation, and a public health insurance system to redistribute the burden of medical services.

Feasibility of automatic evaluation of clinical rules in general practice.

PURPOSE: To assess the extent to which clinical rules (CRs) can be implemented for automatic evaluation of quality of care in general practice. METHODS: We assessed 81 clinical rules (CRs) adapted from a subset of Assessing Care of Vulnerable Elders (ACOVE) clinical rules, against Dutch College of General Practitioners (NHG) data model. Each CR was analyzed using the Logical Elements Rule METHOD: (LERM). LERM is a stepwise method of assessing and formalizing clinical rules for decision support. Clinical rules that satisfied the criteria outlined in the LERM method were judged to be implementable in automatic evaluation in general practice. RESULTS: Thirty-three out of 81 (40.7%) Dutch-translated ACOVE clinical rules can be automatically evaluated in electronic medical record systems. Seven out of 7 CRs (100%) in the domain of diabetes can be automatically evaluated, 9/17 (52.9%) in medication use, 5/10 (50%) in depression care, 3/6 (50%) in nutrition care, 6/13 (46.1%) in dementia care, 1/6 (16.6%) in end of life care, 2/13 (15.3%) in continuity of care, and 0/9 (0%) in the fall-related care. Lack of documentation of care activities between primary and secondary health facilities and ambiguous formulation of clinical rules were the main reasons for the inability to automate the clinical rules. CONCLUSION: Approximately two-fifths of the primary care Dutch ACOVE-based clinical rules can be automatically evaluated. Clear definition of clinical rules, improved GP database design and electronic linkage of primary and secondary healthcare facilities can improve prospects of automatic assessment of quality of care. These findings are relevant especially because the Netherlands has very high automation of primary care.

Do urologists follow the golden rule? A global urolithiasis management study by the Clinical Research Office of the Endourological Society.

INTRODUCTION: The primary objective of this study was to compare surgical management options for various urolithiasis scenarios that urologists would choose for themselves vs. the options they would recommend for their patients. The secondary objective was to identify the common recommended treatments for upper urinary tract stones of various sizes and locations. METHODS: Two surveys were sent by the Clinical Research Office of the Endourological Society (CROES) to members of the Endourological Society. Standard demographic information was collected. The first survey asked the urologists to recommend treatment for urolithiasis in 10 different scenarios assuming that they were the patient with stone disease. The second survey, sent eight months later, asked urologists to recommend treatment for the same 10 scenarios for a theoretical patient. Only urologists who responded to the first and the second survey were included. Recommended treatment options were compared between the surveys. Agreement between the two scenarios was measured with Cohen's kappa. Surveys were conducted on the Internet using SurveyMonkey™. All statistical analyses were performed using R statistical program version 2.12.2. RESULTS: The two surveys had response rates of 78% (160/205) and 84% (172/205), respectively with urologists from 38 countries. Median experience of respondents was seven years (range: 2-30). The majority of respondents, 117 (75%), were affiliated with academic hospitals. Recommended treatments for stone disease in different scenarios were not entirely consistent when the urologists considered themselves as the patients compared to the choice they might recommend for their patients. Cohen's kappa ranged from 0.292-0.534 for the different scenarios. Overall, shock wave lithotripsy (SWL) and ureteroscopy (URS) were the most commonly chosen treatment options, with medical expulsive therapy (MET) and laparoscopy being the least recommended by urologists for themselves, as well as for their patients. CONCLUSIONS: Although urologists were not entirely consistent in their recommendations for stone treatment, they generally followed the "golden rule" and treated their patients as they would want to be treated. The most commonly recommended treatments for upper urinary tract stones were SWL and URS.

Quality of Co-Prescribing NSAID and Gastroprotective Medications for Elders in The Netherlands and Its Association with the Electronic Medical Record.

OBJECTIVE: To assess guideline adherence of co-prescribing NSAID and gastroprotective medications for elders in general practice over time, and investigate its potential association with the electronic medical record (EMR) system brand used. METHODS: We included patients 65 years and older who received NSAIDs between 2005 and 2010. Prescription data were extracted from EMR systems of GP practices participating in the Dutch NIVEL Primary Care Database. We calculated the proportion of NSAID prescriptions with co-prescription of gastroprotective medication for each GP practice at intervals of three months. Association between proportion of gastroprotection, brand of electronic medical record (EMR), and type of GP practice were explored. Temporal trends in proportion of gastroprotection between electronic medical records systems were analyzed using a random effects linear regression model. RESULTS: We included 91,521 patient visits with NSAID prescriptions from 77 general practices between 2005 and 2010. Overall proportion of NSAID prescriptions to the elderly with co-prescription of gastroprotective medication was 43%. Mean proportion of gastroprotection increased from 27% (CI 25-29%) in the first quarter of 2005 with a rate of 1.2% every 3 months to 55%(CI 52-58%) at the end of 2010. Brand of EMR and type of GP practice were independently associated with co-prescription of gastroprotection. CONCLUSION: Although prescription of gastroprotective medications to elderly patients who receive NSAIDs increased in The Netherlands, they are not co-prescribed in about half of the indicated cases. Brand of EMR system is associated with differences in prescription of gastroprotective medication. Optimal design and utilization of EMRs is a potential area of intervention to improve quality of prescription.

Standardization of patient outcomes reporting in percutaneous nephrolithotomy.

BACKGROUND AND PURPOSE: There exist no global standards for defining patient outcomes in renal stone surgery. The objective of this study was to evaluate the quality of reporting of outcomes in studies investigating percutaneous nephrolithotomy (PCNL) and to propose standardized consensus definitions for common outcomes. METHODS: We performed a literature search in PubMed for randomized controlled studies that investigated PCNL between 2002 and 2012. All outcomes reported were analyzed for each study. Each article was examined to identify the definition of each reported patient outcome. Various aspects of patient outcomes were presented to a panel of 85 experts in a Delphi process consisting of three rounds. The experts were asked to select options that they believed would best describe each outcome. Finally, we composed recommendations for definition of the most common outcomes reported in PCNL studies. RESULTS: Eighty-three RCTs were included in the review of patient outcomes. Stone-free rate (55, 63.9%), length of stay (47, 56.6%), complication rate (44, 53.0%), and changes in hemoglobin (40, 48.2%) were the most frequently reported outcomes in randomized controlled trials of PCNL. Only 24/53 (45.3%) studies had a formal definition of stone-free status. Only 31/40 (77.5%) studies, which reported change in hemoglobin, had a unit of measurement; however, 22/40 (55.0%) did not report the timing of postoperative hemoglobin measurement. A set of recommendations for defining patient outcomes in PCNL is presented for the 15 most commonly reported outcomes in PCNL. CONCLUSIONS: Wide variations and underspecification exist in the definition and reporting of outcomes in PCNL. We propose recommendations for the definition of outcomes based on a review of the literature and expert opinion. Standardization of outcome definition and reporting will improve the quality of urologic research.

Inappropriateness of medication prescriptions to elderly patients in the primary care setting: a systematic review.

BACKGROUND: Inappropriate medication prescription is a common cause of preventable adverse drug events among elderly persons in the primary care setting. OBJECTIVE: The aim of this systematic review is to quantify the extent of inappropriate prescription to elderly persons in the primary care setting. METHODS: We systematically searched Ovid-Medline and Ovid-EMBASE from 1950 and 1980 respectively to March 2012. Two independent reviewers screened and selected primary studies published in English that measured (in)appropriate medication prescription among elderly persons (>65 years) in the primary care setting. We extracted data sources, instruments for assessing medication prescription appropriateness, and the rate of inappropriate medication prescriptions. We grouped the reported individual medications according to the Anatomical Therapeutic and Chemical (ATC) classification and compared the median rate of inappropriate medication prescription and its range within each therapeutic class. RESULTS: We included 19 studies, 14 of which used the Beers criteria as the instrument for assessing appropriateness of prescriptions. The median rate of inappropriate medication prescriptions (IMP) was 20.5% [IQR 18.1 to 25.6%.]. Medications with largest median rate of inappropriate medication prescriptions were propoxyphene 4.52 (0.10-23.30)%, doxazosin 3.96 (0.32 15.70)%, diphenhydramine 3.30 (0.02-4.40)% and amitriptiline 3.20 (0.05-20.5)% in a decreasing order of IMP rate. Available studies described unequal sets of medications and different measurement tools to estimate the overall prevalence of inappropriate prescription. CONCLUSIONS: Approximately one in five prescriptions to elderly persons in primary care is inappropropriate despite the attention that has been directed to quality of prescription. Diphenhydramine and amitriptiline are the most common inappropriately prescribed medications with high risk adverse events while propoxyphene and doxazoxin are the most commonly prescribed medications with low risk adverse events. These medications are good candidates for being targeted for improvement e.g. by computerized clinical decision support.

Impact of case volumes on the outcomes of percutaneous nephrolithotomy.

BACKGROUND: Previous studies have demonstrated relationships between case volumes and outcomes in surgery. Little is known about the impact of case volumes on the outcomes of percutaneous nephrolithotomy (PCNL). OBJECTIVE: To investigate the influence of case volumes on the efficacy and safety outcomes of PCNL. DESIGN, SETTING, AND PARTICIPANTS: From November 2007 to December 2009, prospective data were collected by the Clinical Research Office of the Endourological Society from consecutive patients over a 1-yr period in 96 centers globally. Data of 3933 patients in the Global PCNL study database were included in this study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Patients were divided into low- and high-volume groups based on the median annual case volume of their respective treatment center. Preoperative characteristics and outcomes were compared between the two groups. Case volume was treated as a continuous variable. The relationship between case volume and stone-free (SF) rate, complication rate, and duration of hospital stay was explored using multivariate regression analysis. RESULTS AND LIMITATIONS: SF rates were higher in high-volume centers (82.5% vs 75.1%; p value <0.001). Complication rates were lower in high-volume centers (15.9% vs 21.7%; p value 0.002), whereas the mean (standard deviation [SD]) duration of stay was shorter in high-volume centers (3.4 [2.6] vs 4.9 [3.7] d; p value <0.001). SF rate increased with case volume, whereas complication rate and duration of stay diminished with increasing case volumes after adjusting for stone burden, urine culture status, American Society of Anesthesiologists score, and the presence of staghorn stones. The highest SF rates were observed in centers with >120 cases per year. CONCLUSIONS: Centers that perform high numbers of PCNLs per year achieve better results. Both the efficacy and safety outcomes of PCNL improve with the number of surgeries performed in a given center per year.

Categorisation of complications and validation of the Clavien score for percutaneous nephrolithotomy.

BACKGROUND: Although widely used, the validity and reliability of the Clavien classification of postoperative complications have not been tested in urologic procedures, such as percutaneous nephrolithotomy (PCNL). OBJECTIVE: To validate the Clavien score and categorise complications of PCNL. DESIGN, SETTING, AND PARTICIPANTS: Data for 528 patients with complications after PCNL were used to create a set of 70 unique complication-management combinations. Clinical case summaries for each complication-management combination were compiled in a survey distributed to 98 urologists, who rated each combination using the Clavien classification. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Interrater agreement for Clavien scores was estimated using Fleiss' kappa (κ). The relationship between Clavien score and the duration of postoperative hospital stay was analysed using multivariate nonlinear regression models that adjusted for operating time, preoperative urine microbial culture, presence of staghorn stone, and use of postoperative nephrostomy tube. RESULTS AND LIMITATIONS: Overall interrater agreement in grading postoperative complications was moderate (κ=0.457; p<0.001). Agreement was highest for Clavien score 5 and decreased with lower Clavien scores. Higher agreement was found for Clavien scores 3 and 4 than in subcategories of these scores. Postoperative stay increased with higher Clavien scores and was unaffected by inherent differences between study centres. A standard list of post-PCNL complications and their corresponding Clavien scores was created. CONCLUSIONS: Although the Clavien classification demonstrates high validity, interrater reliability is low for minor complications. To improve the reliability and consistency of reporting adverse outcomes of PCNL, we have assigned Clavien scores to complications of PCNL.

LERM (Logical Elements Rule Method): a method for assessing and formalizing clinical rules for decision support.

PURPOSE: The aim of this study was to create a step-by-step method for transforming clinical rules for use in decision support, and to validate this method for usability and reliability. METHODS: A sample set of clinical rules was identified from the relevant literature. Using an iterative approach with a focus group of mixed clinical and informatics experts, a method was developed for assessing and formalizing clinical rules. Two assessors then independently applied the method to a separate validation set of rules. Usability was assessed in terms of the time required and the error rate, and reliability was assessed by comparing the results of the two assessors. RESULTS: The resulting method, called the Logical Elements Rule Method, consists of 7 steps: (1) restate the rule proactively; (2) restate the rule as a logical statement (preserving key phrases); (3) assess for conflict between rules; (4) identify concepts which are not needed; (5) classify concepts as crisp or fuzzy, find crisp definitions corresponding to fuzzy concepts, and extract data elements from crisp concepts; (6) identify rules which are related by sharing patients, actions, etc.; (7) determine availability of data in local systems. Validation showed that the method was usable with rules from various sources and clinical conditions, and reliable between users provided that the users agree on a terminology and agree on when the rule will be evaluated. CONCLUSIONS: A method is presented to assist in assessing clinical rules for their amenability to decision support, and formalizing the rules for implementation. Validation shows that the method is usable and reliable between users. Use of a terminology increases reliability but also the error rate. The method is useful for future developers of systems which offer decision support based on clinical rules.