Carnoy's solution fixation with compression significantly increases the number of lymph nodes yielded from colorectal cancer specimens.

BACKGROUND AND OBJECTIVES: Carnoy's fixation and compression represents a novel technique to enhance lymph node evaluation and accuracy of staging after colorectal cancer resection. METHODS: This study was performed in all adults undergoing colorectal cancer operations by Kaiser Permanente surgeons at two separate facilities. Patients were assigned to either location based upon surgeon and patient availability. One group of patients had their lymph nodes examined with current standard manual technique (MT). The other group had their specimens fixed with Carnoy's solution and then compressed (CT) to assess for lymph nodes. RESULTS: A total of 157 patients were enrolled. Seventy-eight patient specimens underwent MT and 79 patient specimens underwent the new compression technique (CT). CT resulted in a significant increase in total lymph node yield per specimen (37.6 ± 18.5 nodes with CT vs 18.9 ± 8.8 nodes with MT; P < 0.0001). CT also resulted in sufficient lymph node sampling (>12 nodes) in all 79 patients in the group compared with 13 of 78 patients (17%) with an insufficient lymph node evaluation in the MT group ( P = 0.0002). CONCLUSION: This study demonstrated that Carnoy's fixation with compression can significantly increase lymph node yields in colorectal cancer specimens and allow for a higher rate of adequate lymph node sampling.

Key Determinants of the Value of Random Cervical Biopsy at Colposcopy.

OBJECTIVE: The aim of the study was to assess whether lower proportions of cervical intraepithelial neoplasia 2+ diagnosed by random biopsy are from lower cut points defining an abnormal colposcopic impression or obtaining only one random biopsy when colposcopic impression is normal. METHODS: We compared colposcopy experiences within Shanxi Province Cervical Cancer Screening Study (SPOCCS) (n = 1,383) and Shenzhen Cervical Cancer Screening Trial (SHENCCAST) (n = 631), which had instructive differences in the cut point defining an abnormal colposcopic impression. RESULTS: The proportion of CIN 2+ diagnosed by random biopsy in SPOCCS (35.0%, 141/403) was higher than SHENCCAST (18.4%, 35/190, p < .001). Quadrant-specific receiver operating characteristic curves for diagnosis of CIN 2+ by colposcopic impression in SPOCCS and SHENCCAST were similar; a lower cut point for an abnormal colposcopic impression in SHENCCAST resulted in lower proportion of CIN 2+ diagnosed by random biopsy. Normal colposcopic impression was found in 85.1% (120/141) of cases of CIN 2+ diagnosed by random biopsy in SPOCCS and in 57.1% (20/35) of such cases in SHENCCAST. Of CIN 2+ diagnosed by random cervical biopsy with normal colposcopic impression, one cervical quadrant was involved with CIN 2+ in 66.7% (80/120) of colposcopies in SPOCCS and 80% (16/20) of colposcopies in SHENCCAST. CONCLUSIONS: Colposcopy series with higher proportions of CIN 2+ diagnosed by random biopsy likely have more stringent cut points defining an abnormal colposcopic impression and have more random biopsies when the colposcopic impression is normal. At colposcopy, we advise multiple biopsies of all acetowhite epithelium or multiple random biopsies to increase the sensitivity of colposcopy.

Outcomes of Elbow Arthroscopic Osteocapsular Arthroplasty.

PURPOSE: To evaluate the results of elbow arthroscopic osteocapsular arthroplasty (AOA) and determine which factors influence the outcome in a large group of patients with primary osteoarthritis. METHODS: A consecutive series of 46 patients with elbow osteoarthritis underwent AOA by a single surgeon (N.G.H.) between December 2005 and January 2013. Thirty-one patients returned for a comprehensive physical examination an average of 3.4 years later. The outcomes measures included visual analog scale (VAS), Mayo Elbow Performance Scores (MEPS), Disabilities of the Arm, Shoulder, and Hand (DASH), and American Shoulder and Elbow Society (ASES) scores. Preoperative and postoperative continuous variables were compared and a multivariable regression analysis was performed. RESULTS: Thirty-one patients with a mean age of 48 years (range, 19-77 years) returned for final follow-up, including 27 men and 4 women. Statistically significant improvement was observed in extension deficit (24° before surgery to 12° after surgery), flexion (126° before surgery to 135° after surgery), visual analog scale (6.4 before surgery to 1.6 after surgery), and Mayo Elbow Performance Scores (57 [poor] before surgery to 88 [good] after surgery). Subjective scores included a mean postoperative Disabilities of the Arm, Shoulder, and Hand score of 13 and an American Shoulder and Elbow Society pain score of 40. No complications were noted at final follow-up. CONCLUSIONS: Elbow AOA is a safe, efficacious treatment for patients with mild to moderate osteoarthritis. Our retrospective review found significant improvement in elbow motion, pain and clinical outcomes.

Factors That Virtually Exclude Cervical Cancer at Colposcopy.

OBJECTIVES: The objective of this work was to determine the risk of invasive cervical cancer at colposcopy based on the woman's age, associated cervical cytology, and colposcopic impression. METHODS: Review of electronic medical records from colposcopy clinics followed by chart review of women with cervical cancer. RESULTS: Between March 1, 1996, and April 23, 2013, 27,381 cervical colposcopies for evaluation of abnormal cervical cytology and/or positive high-risk human papillomavirus tests were performed. Median age at colposcopy was 32 years (range, 11-91 years). Biopsy at colposcopy or at subsequent loop electrocautery excision procedure, cervical conization, or hysterectomy diagnosed cervical cancer in 0.5% (132/27,381) of women. At colposcopy, the risk of cervical cancer for women younger than 30 years was 0.07% (8/12,131), for women with Cytology-Lo (low-grade squamous intraepithelial lesion, atypical squamous cells of uncertain significance, benign endometrial cells, or negative), it was 0.17% (43/25,779); and for women with normal colposcopic impressions, it was 0.17% (18/11,389). The risk of cervical cancer for women younger than 30 years with Cytology-Lo was 0.01% (1/11,663). CONCLUSIONS: At colposcopy, cervical cancer is not excluded by a normal colposcopic examination result, Cytology-Lo, or age younger than 30 years, but is virtually excluded by the combination of age younger than 30 years and Cytology-Lo.

Which Colposcopies Should Include Endocervical Curettage?

OBJECTIVES: Although endocervical curettage (ECC) is often performed at colposcopy, it remains unclear whether it should be done in all women, only women over a certain age, only women with unsatisfactory colposcopy, or only in women with normal colposcopic impressions. To clarify the indications for ECC, we determined the proportion of colposcopies with CIN 3, or cancer (CIN 3+) detected only by ECC showing CIN 2, CIN 3, or cancer (CIN 2+). METHODS: Review of electronic medical records from colposcopy clinics. RESULTS: Between March 1, 1996, and April 23, 2013, approximately 18,537 cervical colposcopies with no missing results evaluated women with abnormal cervical cytology and/or positive high-risk human papillomavirus tests. In 7.5% (1,398/18,537) of colposcopies, the final diagnosis, based on the worst biopsy from cervix; ECC; or subsequent loop electrocautery excision procedure, cervical conization, or hysterectomy, was CIN 3+. The proportion of colposcopies with CIN 3+ detected only by ECC showing CIN 2+ was 0.5% (101/18,537). Limiting the ECC to women with unsatisfactory colposcopy, colposcopic impressions suggestive of CIN 2+, or impressions of normal resulted in fewer ECC performed but also greatly decreased the proportion of CIN 3+ that could have been detected only by ECC showing CIN 2+. Limiting the ECC to colposcopies in women age 25 years and older resulted in 29.3% (5,433/18,537) fewer ECCs while detecting 96.0% (97/101) of the CIN 3+ that could have been detected only by ECC showing CIN 2 + . CONCLUSIONS: Endocervical curettage should be performed at colposcopy in women age 25 and older.

Improved prenatal detection of congenital heart disease in an integrated health care system.

The reported prenatal detection rates (PDRs) for significant congenital heart disease (sCHD) have been suboptimal, even in the current era. Changes in prenatal ultrasound policy and training may lead to improved prenatal detection of sCHD. This study analyzed the results of a policy to assess fetal cardiac outflow tracts shown by screening prenatal ultrasound using the electronic medical record (EMR). During a 6-year period, fetuses and patients younger than 1 year with sCHD were identified. The EMR was used to gather detection and outcome data. As an internal control within the same health care system, the PDR of only the surgical cases was compared with that of a similar group in which documentation of the fetal cardiac outflow tracts was not standard policy. Among 25,666 births, sCHD was identified in 93 fetuses or patients, yielding an incidence of 3.6 per 1,000 births. The PDR was 74.1%. Detection after birth but before discharge was 20.4%, and detection after discharge was 5.4%. A significant improvement in the PDR of sCHD was found when a concerted effort was made to obtain fetal cardiac outflow tract views during pregnancy screening (59.3 vs. 28%). Within an integrated health care system and with the use of an EMR, a PDR of 74% can be obtained, and 94% of sCHD can be detected before discharge. A concerted program that includes documentation of fetal cardiac outflow tracts in the pregnancy screening can result in improved PDR of sCHD.

Regardless of skill, performing more biopsies increases the sensitivity of colposcopy.

OBJECTIVES: The objectives of this study were to compare the sensitivity of colposcopically directed biopsy (biopsy of cervical quadrants with colposcopic impressions of human papillomavirus, cervical intraepithelial neoplasia [CIN], or cancer) for CIN 3 or cancer (CIN 3+) among physicians and to estimate the increase in yield of CIN 3+ per colposcopy associated with "random" biopsies and/or endocervical curettage (ECC). METHODS: Two studies in which 7 physicians performed 1,383 colposcopic examinations on women with abnormal cervical cytology were reviewed. At colposcopy, the cervix was divided into quadrants by lines from the 12- to the 6-o'clock and from the 3- to the 9-o'clock positions. Each quadrant was assigned a colposcopic impression of normal, human papillomavirus or CIN 1, CIN 2 or CIN 3, or cancer. Each quadrant had biopsy of colposcopically detected lesions or "random" biopsy at the squamocolumnar junction if the colposcopic impression was normal. Lastly, ECC was obtained. RESULTS: Among the physicians, the sensitivity of colposcopically directed biopsy for CIN 3+ varied from 28.6% to 92.9% (p < .001). With logistic regression, the sensitivity of colposcopically directed biopsy for CIN 3+ increased as the number of cervical quadrants with CIN 3+ increased (p < .001); once corrected for the number of quadrants with CIN 3+, differences between the physician's sensitivities remained significant (p = .01). For 6 of 7 physicians, the yield of CIN 3+ per colposcopy was greater when colposcopically directed biopsy was augmented by up to 4 "random" biopsies plus ECC (p = .03 to p < .001). CONCLUSIONS: The sensitivity of colposcopy for CIN 3+ varies widely. Performing up to 4 "random" biopsies plus ECC increases the yield of CIN 3+.

The role of Ifosfamide-doxorubicin chemotherapy in histology-specific, high grade, locally advanced soft tissue sarcoma, a 14-year experience.

PURPOSE: To compare long-term outcomes of high-grade, primary soft-tissue-sarcoma (STS), using Ifosfamide-Doxorubicin vs local therapy alone, in histology-specific sarcomas. METHODS: Retrospective analysis was performed on 127 patients from 2005 to 2018, with high-grade STS of extremity or trunk, >5 cm, that were either Synovial-Cell, Dedifferentiated-Liposarcoma (DDL), Myxofibrosarcoma, Round-Cell-Liposarcoma (RCLS), Undifferentiated-Pleomorphic-Sarcoma (UPS), or Undifferentiated-Sarcoma-not-otherwise-specified (US-NOS), with central pathology review. Ifosfamide-Doxorubicin was generally given neoadjuvant over 5 cycles, followed by radiation and wide excision, with chemotherapy given in 38 patients, while 89 received local therapy alone. Multi-variable-analysis (MVA) of prognostic factors was performed, and local-recurrence-free-survival (LRFS), distant-metastases-free-survival (DMFS), disease-specific-survival (DSS), and overall-survival (OS) were estimated using Kaplan-Meier, and adjusted using propensity-score matching. RESULTS: Median follow-up was 4.5 years. Younger age (p < 0.0001) and Synovial histology (p = 0.0002) were more likely to undergo chemotherapy. Ifosfamide-Doxorubicin improved 5-year DMFS (p = 0.02), DSS (p = 0.01), and OS (p = 0.01), by univariate comparisons, as well as sub-analysis of non-synovial histology, but significance was lost after propensity-score matching for DMFS (p = 0.10), DSS (p = 0.09), and OS (p = 0.07). Size >10 cm, trunk location, and lack of chemotherapy significantly lowered DMFS, DSS, and OS on MVA, while DDL had more favorable survival; although size, trunk location, and DDL histology were not significantly different between treatment groups. Ifosfamide-Doxorubicin independently improved DMFS (p = 0.001), DSS (p = 0.01), and OS (p = 0.001) on MVA. CONCLUSION: Ifosfamide-Doxorubicin may be more beneficial in younger patients with >5 cm, high-grade, STS of the trunk or extremity in Synovial-Cell, DDL, Myxofibrosarcoma, RCLS, UPS, and US-NOS.

The Relationship Between Racial/Ethnic Concordance and Hypertension Control.

INTRODUCTION: Given the increasing impact of the healthcare cost of hypertension on the economy, understanding the control of high blood pressure is warranted, particularly as it pertains to racial/ethnic disparities in hypertension control. OBJECTIVE: To understand the relationship between hypertension control and racial/ethnic concordance, we investigated whether the racial/ethnic concordance between a patient's race/ethnicity and that of the individual's provider is a predictor of high blood pressure control. METHODS: Data was collected for 612,524 patients from Kaiser Permanente Southern California who were at least 18 year old and received a diagnosis of hypertension between January 1, 2016 and December 31, 2019. A multiple regression analysis was carried out to assess the correlation between hypertension control and patient-provider concordance. RESULTS: The independent variables proxying for patient-provider relationship are positive and statistically significant at the 5% level. Out of the 3 types of concordance, language has the highest standardized estimate, followed by gender and race. DISCUSSION: We found correlations between racial/ethnic patient-provider concordance and hypertension control. Consistent with previous studies, we found that Asian patients experience more time in hypertension control. By contrast, Black and Hispanic patients have less time in hypertension control. Having the same primary care provider for a longer span of time is also positively correlated with length of hypertension control. CONCLUSION: Correlation between racial/ethnic concordance, length of time under the primary provider's care, and length of time spent in hypertension control suggests that the patient-provider relationship remains a critical component of health outcomes.

Prevalence of type-specific human papillomavirus in endocervical, upper and lower vaginal, perineal and vaginal self-collected specimens: Implications for vaginal self-collection.

To determine why a vaginal self-collection tested for high-risk human papillomavirus (HR-HPV) by Hybrid Capture 2(R) (hc2) has lower sensitivity and specificity for cervical intraepithelial neoplasia Grade 2 or worse (> or = CIN 2), we collected 5 specimens (endocervix, upper and lower vagina, perineum, vaginal self-collection) from 2,625 women. Endocervical and self-collected specimens had HR-HPV tests by hc2. All 5 anogenital specimens were tested for 37 HPV genotypes [Linear Array(R), (LA)] from 397 women hc2 positive in endocervical or self-collected specimens and for a randomly selected 71 of 2,228 women hc2 negative on both specimens. Three hundred nintey-five women who screened positive by hc2 or had abnormal cytology underwent colposcopic evaluation. Of 47 women with > or = CIN 2, hc2 was positive in 97.9% (46/47) of endocervical and 80.9% (38/47), p = 0.008 of self-collected specimens. Seven of 9 women with > or = CIN 2 and negative self-collected hc2 tests were positive for HR-HPV by LA. Of 2,578 women without > or = CIN 2, hc2 was positive in 9.8% (253/2,578) of endocervical and 11.4% (294/2,578), p = 0.001 of self-collected specimens. Of the 41 more women without > or = CIN 2 that tested hc2 positive on the self-collected but negative on endocervical specimen, LA tested positive for HR-HPV in 24, negative for HPV in 11 and negative for HR-HPV but positive for low-risk HPV in 6. Lower sensitivity of self-collected specimens is secondary to lower levels of vaginal HR-HPV. The principal cause of the lower specificity of self-collected specimens is HR-HPV present solely in the vagina, which is not associated with > or = CIN 2.

Outpatient treatment of acute diverticulitis: rates and predictors of failure.

PURPOSE: Many patients with acute diverticulitis can be managed as outpatients, but the success rate of this approach has not been thoroughly studied. We analyzed a large cohort of patients treated on an outpatient basis for an initial episode of acute diverticulitis to test our hypothesis that outpatient treatment of acute diverticulitis is highly effective. METHODS: We analyzed patients within the Kaiser Permanente Southern California system (from 2006 to 2007) who were diagnosed with an initial episode of diverticulitis during an emergency room visit and subsequently discharged home. Each patient underwent a computed tomography (CT) scan for diagnosis or for confirmation of a diagnosis, and each radiologic report was evaluated regarding the presence of free fluid, phlegmon, perforation, and abscess. Treatment failure was defined as a return to the emergency room or an admission for diverticulitis within 60 days of the initial evaluation. RESULTS: Our study included 693 patients, of whom 54% were women, the average age was 58.5 years, and 6% failed treatment. In multivariate analysis, women (odds ratio, 3.08 [95% CI, 1.31-7.28]) and patients with free fluid on CT scan (odds ratio, 3.19 [95% CI, 1.45-7.05]) were at significantly higher risk for treatment failure. Age, white blood cell count, Charlson score, and duration of antibiotics were not significant predictive factors. CONCLUSIONS: In a retrospective analysis, among a cohort of patients who were referred for outpatient treatment, we found that such treatment was effective for the vast majority (94%) of patients. Women and those with free fluid on CT scan appear to be at higher risk for treatment failure.

Effect of prior abdominal surgery, peritonitis, and adhesions on catheter function and long-term outcome on peritoneal dialysis.

Adhesions from previous surgery and peritonitis can lead to peritoneal dialysis catheter insertion failure, visceral injury, and poor dialysis function. Employing a laparoscopic approach, the effect of adhesiolysis on mechanical catheter complications and long-term catheter survival was prospectively examined in 436 catheter placement procedures having a 57.8 per cent prevalence rate of previous surgery. Adhesiolysis was required in 31.8 per cent of cases with prior surgery and in 3.3 per cent of procedures without previous operations. The incidence of adhesiolysis was directly related to the number of prior surgeries (P < 0.0001). The incidence of catheter insertion failure from extensive adhesions was 1.8 per cent. Survival probability free from catheter obstruction was lower in patients requiring adhesiolysis compared with subjects with prior surgery not requiring adhesiolysis (P = 0.01). Laparoscopic rescue procedures limited catheter losses from flow obstruction to only 0.7 per cent. As a result, long-term catheter survival was not different among patients regardless of prior surgery and/or adhesion status (P = 0.2). Scars on the abdomen and prior peritonitis do not predict the extent of adhesions and should not be used to judge eligibility for peritoneal dialysis. Presently, laparoscopy is the only practical way to provide optimal peritoneal access in patients with a history of surgery and peritonitis.

Complications of Radial Column Plating of the Distal Radius.

Background: Distal radius fractures treated with open reduction and internal fixation are commonly stabilized with a volar locking plate; however, more complex fracture patterns may require supplemental fixation with fragment-specific implants. The objective of this study was to evaluate the outcomes of distal radius fractures treated with radial column plates. Methods: A consecutive series of 61 patients who sustained distal radius fractures underwent radial column plating alone or in conjunction with other implants between August 2006 and January 2014. Thirty-one patients returned for follow-up or returned a mailed questionnaire at an average of 4.1 years. The outcomes measures included Visual Analog Scale (VAS); Disabilities of the Arm, Shoulder and Hand (DASH); and Patient-Rated Wrist Evaluation (PRWE) scores. Results: Sixty-one patients with a mean age of 55 years (range, 20-87) met inclusion criteria and were available for follow-up or chart review at an average of 5.2 years (range, 1.6-9.0 years). Seventeen of 61 (28%) underwent radial column plate removal. Twenty patients returned for final follow-up examination, and 11 completed questionnaires via mail. Subjective scores included a mean postoperative VAS of 0.72, DASH score of 17.2, and PRWE score of 15.7. Hardware sensitivity and wrist stiffness were the most common complications at final follow-up. Conclusions: Radial column plating of the distal radius is a safe treatment modality and a valuable adjunct in the setting of complex distal radius fractures, but patients should be counseled that there is a 28% chance that hardware removal may be required. Our retrospective review found evidence of few complications and objective scores consistent with return to normal function.

Hospitalization rates in daily home hemodialysis versus peritoneal dialysis patients in the United States.

BACKGROUND: Daily hemodialysis (DHD) is associated with improvements in hypertension, left ventricular hypertrophy, mineral metabolism, nutrition, and quality of life, but efficacy is uncertain because of potential selection bias. To reduce the influence of selection bias, we sought to compare hospital admissions for our population of DHD patients with peritoneal dialysis (PD) patients who initiated training during the same period. We also compared our hospital data with the US Renal Data Service database. STUDY DESIGN: Prospective nonrandomized cohort study. SETTING & PARTICIPANTS: 22 (16 male) DHD and 64 (33 male) PD patients who initiated training between March 2003 and September 2007 at our center and remained in our program for at least 6 months. PREDICTORS: Dialysis modality (DHD or PD). OUTCOMES: Number of hospital admissions and length of stay. RESULTS: Median age at initiation of training was 52 years (range, 33 to 76 years) for DHD patients versus 54 years (range, 21 to 82 years) for PD patients (P = 0.5), and median vintage was 23 months (range, 0 to 145 months) for DHD patients versus 0 month (range, 0 to 244 months) for PD patients (P < 0.001). Fifty percent of DHD and 56% of PD patients had a diagnosis of diabetes mellitus (P = 0.8). We observed 27 DHD and 82 PD admissions (0.68 and 0.76 admissions/patient-year, respectively) during the study period (P = 0.5). We also observed 130 DHD and 605 PD hospital days (3.3 and 5.6 days/patient-year, respectively; P < 0.001). LIMITATIONS: Patients were not randomly assigned between the study group and control group; study group was small. CONCLUSIONS: Our study suggests that despite similar patient demographics, patients treated with DHD spend fewer days in the hospital than PD patients in the United States. Although selection bias could partially explain our lower hospitalization rate, other factors, including improvements in blood pressure control, nutrition, and fewer fluctuations in dry weight, probably contributed to the stability of our patients.

Performance of the GeneXpert enterovirus assay for detection of enteroviral RNA in cerebrospinal fluid.

BACKGROUND: The GeneXpert Dx System allows for automated extraction, processing, amplification and real-time detection of target nucleic acids. OBJECTIVES: To evaluate the performance of the Cepheid Xpert enterovirus (EV) assay for detection of EV RNA compared to a nucleic acid sequence based amplification (NASBA) assay and a user-developed TaqMan RT-PCR assay. STUDY DESIGN: Assays were evaluated using a 12-member proficiency panel and up to 138 CSF specimens. Samples in which EV RNA was detected by two or more assays were considered true positives. RESULTS: The GeneXpert, NASBA, and TaqMan assays correctly identified 10, 8, and 7 of 12 proficiency panel members, respectively. For detection of EV RNA in CSF, the sensitivities of the GeneXpert, NASBA, and TaqMan were 100%, 87.5%, and 96%, respectively. There were no false positives. Two samples tested by GeneXpert and NASBA yielded indeterminate or invalid results and could not be resolved. CONCLUSIONS: The Xpert EV assay is a sensitive and specific method for detection of EV RNA in CSF specimens. The ease of use, random access capability, and minimal hands-on time with the automated GeneXpert system affords laboratories with little molecular diagnostics expertise an opportunity to complete a clinically useful testing within 2.5 h.

Outcome after anterior vaginal prolapse repair: a randomized controlled trial.

OBJECTIVES: To report 1-year outcomes of a randomized controlled trial comparing polypropylene mesh-reinforced anterior vaginal prolapse repair with anterior colporrhaphy. METHODS: Seventy-six patients with stage II or greater anterior vaginal prolapse were randomly assigned to either colporrhaphy or polypropylene mesh repair. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events. RESULTS: Thirty-eight women had anterior colporrhaphy, and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study before surgery. Clinical and demographic data did not differ significantly between the two treatment groups. One year after surgery, optimal and satisfactory anterior vaginal support were obtained in 21 of 38 (55%) of the colporrhaphy group and 33 of 38 (87%) of the mesh group (P=.005). Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms. The rates of de novo dyspareunia were 4 of 26 (16%) and 2 of 23 (9%) in the colporrhaphy and mesh groups, respectively. Two of 37 (5%) patients had vaginal mesh extrusion. Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion. Neither serious adverse events nor deaths occurred in either group. CONCLUSION: Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year. However, quality of life and sexual symptoms scores improved in both groups.

Sodium bicarbonate vs sodium chloride for the prevention of contrast medium-induced nephropathy in patients undergoing coronary angiography: a randomized trial.

CONTEXT: Sodium bicarbonate has been suggested as a possible strategy for prevention of contrast medium-induced nephropathy, a common cause of renal failure associated with prolonged hospitalization, increased health care costs, and substantial morbidity and mortality. OBJECTIVE: To determine if sodium bicarbonate is superior to sodium chloride for preventing contrast medium-induced nephropathy in patients with moderate to severe chronic kidney dysfunction who are undergoing coronary angiography. DESIGN, SETTING, AND PATIENTS: Randomized, controlled, single-blind study conducted between January 2, 2006, and January 31, 2007, and enrolling 353 patients with stable renal disease who were undergoing coronary angiography at a single US center. Included patients were 18 years or older and had an estimated glomerular filtration rate of 60 mL/min per 1.73 m(2) or less and 1 or more of diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years. INTERVENTIONS: Patients were randomized to receive either sodium chloride (n = 178) or sodium bicarbonate (n = 175) administered at the same rate (3 mL/kg for 1 hour before coronary angiography, decreased to 1.5 mL/kg per hour during the procedure and for 4 hours after the completion of the procedure). MAIN OUTCOME MEASURE: The primary end point was a 25% or greater decrease in the estimated glomerular filtration rate on days 1 through 4 after contrast exposure. RESULTS: Median patient age was 71 (interquartile range, 65-76) years, and 45% had diabetes mellitus. The groups were well matched for baseline characteristics. The primary end point was met in 13.3% of the sodium bicarbonate group and 14.6% of the sodium chloride group (relative risk, 0.94; 95% confidence interval, 0.55-1.60; P = .82). In patients randomized to receive sodium bicarbonate vs sodium chloride, the rates of death, dialysis, myocardial infarction, and cerebrovascular events did not differ significantly at 30 days (1.7% vs 1.7%, 0.6% vs 1.1%, 0.6% vs 0%, and 0% vs 2.2%, respectively) or at 30 days to 6 months (0.6% vs 2.3%, 0.6% vs 1.1%, 0.6% vs 2.3%, and 0.6% vs 1.7%, respectively) (P > .10 for all). CONCLUSION: The results of this study do not suggest that hydration with sodium bicarbonate is superior to hydration with sodium chloride for the prevention of contrast medium-induced nephropathy in patients with moderate to severe chronic kidney disease who are undergoing coronary angiography. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00312117.

Knee replacement: epidemiology, outcomes, and trends in Southern California: 17,080 replacements from 1995 through 2004.

BACKGROUND AND PURPOSE: There are limited population-based data on utilization, outcomes, and trends in total knee arthroplasty (TKA). The purpose of this study was to examine TKA utilization and short-term outcomes in a pre-paid health maintenance organization (HMO), and to determine whether rates and revision burden changed over time. We also studied whether this population is representative of the general population in California and in the United States. METHODS: Using hospital utilization and membership databases from 1995 through 2004, we calculated incidence rates (IRs) of primary and revision TKA for every 10,000 health plan members. The demographics of the HMO population were compared to published census data from California and the United States. RESULTS: The age and sex distributions of the study population were similar to those of the general population in California and the United States. 15,943 primary TKAs and 1,137 revision TKAs were performed during the 10-year period. Patients below the age of 65 accounted for one-third of all primary replacements and one-third of all revision replacements. IRs of primary TKAs increased from 6.3 per 10,000 in 1995 to 11.0 per 10,000 in 2004, at a rate of 5% per year (p<0.001). IRs of revision TKAs increased from 0.41 per 10,000 in 1995 to 0.74 per 10,000 in 2004 (p=0.4). Revision burden remained stable over the 10-year observation period. Surgical complications were higher in revision TKA than in primary TKA (10% vs. 7.7%; p=0.007). 90 day complication rates for primary and revision TKA including death were 0.3% and 0.6% (p=0.1) and for pulmonary embolism 0.5% and 0.4% (p=0.6). 90 day re-admission rates for primary and revision TKA including infection were 0.5% and 4.2% (p<0.001), for myocardial infarction 0.1% each, and for pneumonia 0.2% and 0.4% (p=0.08). INTERPRETATION: The incidence of primary and revision TKA increased between 1995 and 2005. The rates of postoperative complications were low. Comparisons of the study population and the underlying general populations of interest indicate that this population can be used to predict the incidences and outcomes of TKA in the general population of California and of the United States as a whole.

Mail order pharmacy use and adherence to secondary prevention drugs among stroke patients.

BACKGROUND AND PURPOSE: Mail order pharmacies (MOP) are increasingly being used to deliver medications for chronic disease management. Their use is linked to similar or even greater medication adherence than local pharmacy (LP) use. We are unaware of any studies that have evaluated the association of mail order pharmacy use with drug adherence among stroke patients. METHODS: We conducted cross-sectional analyses of patients discharged with ischemic stroke from 24 hospitals in a managed care network, who received a new anticoagulant, antiplatelet, anti-glycemic, antihypertensive, and/or lipid-lowering medication between January 1, 2007 and June 30, 2015. We defined good adherence as medication availability ≥80% of the time, and compared adherence between mail-order users (≥66% of refills by mail) and local pharmacy users (all refills in person). Relationship between delivery method and adherence was evaluated using multivariate regression models. RESULTS: A total of 44,658 eligible patients refilled an index medication. Of these, 13,295 in the LP and 6801 in MOP groups met inclusion criteria. Patients in the MOP group were more likely to be white, and less likely to have hypertension, diabetes, and smoke tobacco. Continuous Medication Gap (CMG) adherence was 0.28 in the LP group and 0.11 in the MOP group (p < 0.001). At 90-days there were 893 hospital readmissions for the LP group and 375 for the MOP group for a rate of 0.07 vs 0.06 (p < 0.001). In the multivariable analysis, adherence was associated with MOP use, (OR 0.12, 95% CI 0.11-0.14) and decreased readmission at 90 days (OR 0.62, 95% CI 0.55-0.71). CONCLUSIONS: Stroke patients who use MOP vs. LP are more likely to have good medication adherence. Future studies should examine the impact of mail-order pharmacy use on vascular risk marker control and events after stroke.

Inappropriate gold standard bias in cervical cancer screening studies.

As acetic acid-aided visual inspection (VIA) and colposcopic-directed biopsy miss small >/=cervical intraepithelial neoplasia (CIN) 2, inflation of sensitivity of VIA may occur when colposcopic-directed biopsy is the gold standard for >/=CIN 2. To determine whether such inflation occurs, we reviewed 375 women with >/=CIN 2 from the Shanxi Province Cervical Cancer Screening Study II. These women had positive self or physician-collected tests for high-risk human papillomavirus or abnormal cervical cytology and had VIA followed by colposcopy with directed biopsy and endocervical curettage (ECC). If a cervical quadrant had no lesion, a random biopsy at the squamocolumnar junction within that quadrant was obtained. Sensitivity of colposcopic-directed biopsy was higher for >/=CIN 2 involving 3-4 cervical quadrants (81.3%) than for >/=CIN 2 involving 0-2 quadrants (49.0%, p < 0.001). Sensitivities of VIA, cytology of >/=ASC-US, >/=LSIL, and >/=HSIL were higher for >/=CIN 2 involving 3-4 quadrants than for >/=CIN 2 involving 0-2 quadrants. When a colposcopic-directed biopsy gold standard was compared with that of a 5-biopsy standard (which included >/=CIN 2 from colposcopic-directed biopsy, random biopsy, or ECC), the sensitivity for >/=CIN 2 of VIA was inflated by 20.0% (65.9% vs. 45.9%, p < 0.001). Sensitivities of other screening tests were not affected. Similar inflation of sensitivity of VIA was found with an endpoint of >/=CIN 3 (70.4% vs. 52.0%, p = 0.0013). Inflation of sensitivity of VIA depended upon agreement between colposcopic-directed biopsy and the screening tests as measured by kappa. Studies of VIA that used colposcopic-directed biopsy as the gold standard require reevaluation.