Search

Background: Vaginal practices (VP) may adversely affect normal vaginal flora and mucosal integrity, and increase acquisition risk of HIV and other genital tract infections., Objective: The aim of this study was to describe self-reported VP, changes in the reported number of VP over time and factors associated with VP in a cohort of young Sowetan women enrolled in the HVTN 915 observational study., Method: We longitudinally assessed self-reported VP in 50 young women at risk of HIV acquisition aged 18-25 years in a prospective study over 3 months in Soweto, South Africa. Interviewer-administered HIV behavioural risk questionnaires were completed. No intervention to reduce VP was specified per protocol, but clinicians provided education at their discretion. The generalised estimating equation with inverse probability weights assessed VP over time., Results: The mean age at screening was 22 years; women reported multiple sexual partnerships with a mean of one main and 2 casual partners in the last 30 days. Consistent condom use was 2% ( n = 1), 25% ( n = 12) and 43% ( n = 3) with main, casual and new partners, respectively. Commonly reported VP included washing the vagina with water (44%) and using fingers (48%). VP decreased significantly over time ( p < 0.001). Women who used condoms inconsistently or whose last sex was with a casual partner were 3 times more likely to report VP ( p = 0.001)., Conclusion: Despite the high incidence of HIV in our setting, VP are still common and are associated with other behavioural risks for HIV. Further study is needed to assess whether clinician education may reduce VP and therefore should be included in HIV risk reduction counselling., Competing Interests: The authors declare that they have no financial or personal relationship(s) that may have inappropriately influenced them in writing this article.

Recall and social desirability bias undermine self-report of paper-and-pencil questionnaires. Mobile phone questionnaires may overcome these challenges. We assessed and compared sexual risk behavior reporting via in-clinic paper-and-pencil and mobile phone questionnaires. HVTN 915 was a prospective cohort study of 50 adult women in Soweto, who completed daily mobile phone, and eight interviewer-administered in-clinic questionnaires over 12 weeks to assess sexual risk. Daily mobile phone response rates were 82% (n = 3486/4500); 45% (n = 1565/3486) reported vaginal sex (median sex acts 2 (IQR: 1-3)) within 24 h and 40% (n = 618/1565) consistent condom. Vaginal sex reporting was significantly higher via mobile phone across all visits (p < 0.0001). There was no significant difference in condom use reporting by mobile phone and in-clinic paper-based questionnaires across all visits (p = 0.5134). The results show high adherence and reporting of sex on the mobile phone questionnaire. We demonstrate feasibility in collecting mobile phone sexual risk data.

Objectives:  To compare cancer specific survival after thoracoscopic sublobar lung resection and stereotactic ablative radiotherapy (SABR) for tumors ≤2 cm in size and thoracoscopic resection (sublobar resection or lobectomy) and SABR for tumors ≤5 cm in size., Design:  National population based retrospective cohort study with propensity matched comparative analysis., Setting:  Surveillance, Epidemiology, and End Results (SEER) registry linked with Medicare database in the United States., Participants:  Patients aged ≥66 with lung cancer undergoing SABR or thoracoscopic lobectomy or sublobar resection from 1 Oct 2007 to 31 June 2012 and followed up to 31 December 2013., Main Outcome Measures:  Cancer specific survival after SABR or thoracoscopic surgery for lung cancer., Results:  690 (275 (39.9%) SABR and 415 (60.1%) thoracoscopic sublobar lung resection) and 2967 (714 (24.1%) SABR and 2253 (75.9%) thoracoscopic resection) patients were included in primary and secondary analyses. The average age of the entire cohort was 76. Follow-up of the entire cohort ranged from 0 to 6.25 years, with an average of three years. In the primary analysis of patients with tumors sized ≤2 cm, 37 (13.5%) undergoing SABR and 44 (10.6%) undergoing thoracoscopic sublobar resection died from lung cancer, respectively. The cancer specific survival diverged after one year, but in the matched analysis (201 matched patients in each group) there was no significant difference between the groups (SABR v sublobar lung resection mortality: hazard ratio 1.32, 95% confidence interval 0.77 to 2.26; P=0.32). Estimated cancer specific survival at three years after SABR and thoracoscopic sublobar lung resection was 82.6% and 86.4%, respectively. The secondary analysis (643 matched patients in each group) showed that thoracoscopic resection was associated with improved cancer specific survival over SABR in patients with tumors sized ≤5 cm (SABR v resection mortality: hazard ratio 2.10, 1.52 to 2.89; P<0.001). Estimated cancer specific survival at three years was 80.0% and 90.3%, respectively., Conclusions:  This propensity matched analysis suggests that patients undergoing thoracoscopic surgical resection, particularly for larger tumors, might have improved cancer specific survival compared with patients undergoing SABR. Despite strategies used in study design and propensity matching analysis, there are inherent limitations to this observational analysis related to confounding, similar to most studies in healthcare of non-surgical technologies compared with surgery. As the adoption of SABR for the treatment of early stage operable lung cancer would be a paradigm shift in lung cancer care, it warrants further thorough evaluation before widespread adoption in practice., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Importance: For early-stage breast cancer, breast conservation surgery (BCS) is a conservative option for women and involves removing the tumor with a margin of surrounding breast tissue. If margins are not tumor free, patients undergo additional surgery to avoid local recurrence., Objectives: To investigate the use of BCS in New York State and to determine rates of reoperation, procedure choice, and the effect of surgeon experience on the odds of a reoperation 90 days after BCS., Design, Setting, and Participants: A population-based sample of 89 448 women undergoing primary BCS for cancer were selected and examined from January 1, 2003, to December 31, 2013, in New York State mandatory reporting databases. All hospitals and ambulatory surgery centers in New York State were included. Data were analyzed from December 15, 2014, to November 1, 2015., Main Outcomes and Measures: Rate of reoperations within 90 days of the initial BCS procedure., Results: During the study period, 89 448 women 20 years or older (mean [SD] age, 61.7 [13.7] years) underwent primary BCS. In 2013, 1416 women in New York aged 20 to 49 years underwent BCS compared with 3068 women aged 50 to 64 years and 3644 women 65 years or older. These numbers represent a significant decrease from 1960 women younger than 50 years in 2003 who underwent BCS (P < .001 for trend) but little change from the 2899 women aged 50 to 64 years and 3270 women 65 years or older who underwent BCS in 2003. Mean overall rate of 90-day reoperation was 30.9% (27 010 of 87 499 patients) and decreased over time from 39.5% (6630 of 16 805 patients) in 2003 to 2004 to 23.1% (5148 of 22 286 patients) in 2011 to 2013. Rates of reoperation were highest in women aged 20 to 49 years (37.7% [6990 of 18 524]) and lowest in women 65 years or older (26.3% [9656 of 36 691]) (P < .001 for trend). Over time, more patients underwent BCS as a subsequent procedure, from 4237 of 6630 patients (63.9%) in 2003 to 2004 to 4258 of 5148 (82.7%) in 2011 to 2013 (P < .001 for trend). Among the 19 466 women who underwent BCS as a second procedure, 2429 (12.5%) required a third intervention (2.7% of all women included). Significant surgeon-level variation was found in the data; 90-day rates of reoperations by surgeon ranged from 0% to 100%. Low-volume surgeons (<14 cases per year) had an unadjusted rate of 35.2% compared with 29.6% in middle-volume (14-33 cases per year) and 27.5% in high-volume (≥34 cases per year) surgeons. The difference persisted in adjusted analyses (odds ratio for low-volume surgeons, 1.49 [95% CI, 1.19-1.87]; for middle-volume surgeons, 1.20 [95% CI, 0.93-1.56]) compared with high-volume surgeons (used as the reference category)., Conclusions and Relevance: Use of BCS has decreased overall, most steeply in younger women. Nearly 1 in 4 women underwent a reoperation within 90 days of BCS across New York State from 2011 to 2013, compared with 2 in 5 from 2003 to 2004. Rates vary significantly by surgeon, and initial BCS performed by high-volume surgeons was associated with a 33% lower risk for a reoperation.

Background: The hospital volume-outcome relationship for complex procedures has led to the suggestion that care should be centralized. This study was performed to investigate whether centralization is occurring for pancreatoduodenectomy (PD) and to examine its effect on short-term postoperative outcomes., Methods: We queried the New York State Statewide Planning and Research Cooperative System database (n = 6,185, 2002-2011) and the California and Florida State Inpatient Databases (n = 6,766 and 4,810, respectively, 2002-2011) for PD. Hospitals were divided into low (≤10), medium (11-25), high (25-60), and very high (≥61) groups depending on annual volume. Hierarchical logistic modeling accounted for patient clustering within hospitals., Results: A migration of cases from low-volume to medium, high, and very high-volume (MHVH) hospitals occurred in these 3 states (P < .01). There was an increase in the number of MHVH hospitals and a decrease in the number of low-volume hospitals performing PD across all states over time, with a large number of hospitals ceasing to perform PD cases entirely. Comorbidities such as congestive heart failure and diabetes were more prevalent in low-volume hospitals. After we adjusted for all predictors, MHVH hospitals had less rates of mortality and morbidity and shorter durations of stay than low-volume hospitals (P < .05); 30-day readmission rates were similar across all volume groups., Conclusion: Centralization of PD is occurring in these 3 states and probably across the nation. After PD, MHVH hospitals had statistically better outcomes (mortality, morbidity, and duration of stay) than low-volume hospitals. Readmission rates were not affected by volume., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Previous studies have shown that high-volume centers and laparoscopic techniques improve outcomes of colectomy. These evidence-based measures have been slow to be accepted, and current trends are unknown. In addition, the current rates and outcomes of robotic surgery are unknown., Objective: The purpose of this study was to examine current national trends in the use of minimally invasive surgery and to evaluate hospital volume trends over time., Design: This was a retrospective study., Settings: This study was conducted in a tertiary referral hospital., Patients: Using the National Inpatient Sample, we evaluated trends in patients undergoing elective open, laparoscopic, and robotic colectomies from 2009 to 2012. Patient and institutional characteristics were evaluated and outcomes compared between groups using multivariate hierarchical-logistic regression and nonparametric tests. The National Inpatient Sample includes patient and hospital demographics, admission and treating diagnoses, inpatient procedures, in-hospital mortality, length of hospital stay, hospital charges, and discharge status., Main Outcome Measures: In-hospital mortality and postoperative complications of surgery were measured., Results: A total of 509,029 patients underwent elective colectomy from 2009 to 2012. Of those 266,263 (52.3%) were open, 235,080 (46.2%) laparoscopic, and 7686 (1.5%) robotic colectomies. The majority of minimal access surgery is still being performed at high-volume compared with low-volume centers (37.5% vs 28.0% and 44.0% vs 23.0%; p < 0.001). A total of 36% of colectomies were for cancer. The number of robotic colectomies has quadrupled from 702 in 2009 to 3390 (1.1%) in 2012. After adjustment, the rate of iatrogenic complications was higher for robotic surgery (OR = 1.73 (95% CI, 1.20-2.47)), and the median cost of robotic surgery was higher, at $15,649 (interquartile range, $11,840-$20,183) vs $12,071 (interquartile range, $9338-$16,203; p < 0.001 for laparoscopic)., Limitations: This study may be limited by selection bias by surgeons regarding the choice of patient management. In addition, there are limitations in the measures of disease severity and, because the database relies on billing codes, there may be inaccuracies such as underreporting., Conclusions: Our results show that the majority of colectomies in the United States are still performed open, although rates of laparoscopy continue to increase. There is a trend toward increased volume of laparoscopic procedures at specialty centers. The role of robotics is still being defined, in light of higher cost, lack of clinical benefit, and increased iatrogenic complications, albeit comparable overall complications, as compared with laparoscopic colectomy.

Background: Insulin resistance and glucose intolerance have been associated with increased plasma levels of branched-chain amino acids (BCAA). BCAA levels do not predict T2DM in the population. We determined the discriminative ability of fasting BCAA levels for glucose intolerance in nondiabetic relatives of patients with T2DM of two different ethnicities., Methods: Based on oral glucose tolerance test (OGTT), first-degree relatives of patients with T2DM were categorized as normal glucose tolerance, prediabetes, or T2DM. Included were 34, 12, and 18 Caucasian and 22, 12, and 23 Asian Indian participants, respectively. BCAA levels were measured in fasting plasma together with alanine, phenylalanine, and tyrosine. Insulin sensitivity and beta-cell function were assessed by indices derived from an extended OGTT and their relationship with plasma BCAA levels was assessed in multivariate regression analysis. The value of the amino acids for discriminating prediabetes among nondiabetic family members was determined with the area under the curve of receiver-operated characteristics (c-index)., Results: BCAA levels were higher in diabetic than in normoglycemic family members in the Caucasians (P = 0.001) but not in the Asian Indians. In both groups, BCAA levels were associated with waist-hip ratio (β = 0.31; P = 0.03 and β = 0.42; P = 0.001, respectively) but not with indices of insulin sensitivity or beta-cell function. The c-index of BCAA for discriminating prediabetes among nondiabetic participants was 0.83 and 0.74 in Caucasians and Asian Indians, respectively, which increased to 0.84 and 0.79 by also including the other amino acids. The c-index of fasting glucose for discriminating prediabetes increased from 0.91 to 0.92 in Caucasians and 0.85 to 0.97 (P = 0.04) in Asian Indians by inclusion of BCAA+alanine, phenylalanine, and tyrosine., Conclusions: Adding fasting plasma BCAA levels, combined with phenylalanine, tyrosine and alanine to fasting glucose improved discriminative ability for the prediabetic state within Asian Indian families at risk for T2DM. BCAA levels may serve as biomarkers for early development of glucose intolerance in these families.

Aims: We explored re-interventions and short and long term adverse events associated with procedures for male incontinence among Medicare beneficiaries., Methods: All inpatient and outpatient claims for a simple random sample of Medicare beneficiaries for 2000-2011 were queried to identify patients of interest. All male patients with an International Classification of Diseases, 9th Edition (ICD-9) diagnosis code for stress incontinence or mixed incontinence were included. Artificial urinary sphincter recipients, patients who underwent a sling operation and those receiving an injection of a bulking agent were identified with Current Procedure Terminology (CPT-4) and ICD-9 Procedure Codes., Results: The entire cohort of 1,246 patients were operated on between 2001 and 2011. 34.9% of them received an artificial urinary sphincter (AUS), 28.7% with a bulking agent, and 36.4% with a sling. There were no statistically significant differences in demographics or comorbidities between the treatment groups, except that more sling patients were obese (P = 0.006) and fewer bulk patients had diabetes (P = 0.007). There are, however, significant changes in procedures selected over time (P < 0.001). In the first year and over the entire follow-up after surgery, patients treated with bulking agents had the most subsequent interventions (40.1% and 52.9%), followed by sling (10.4% and 15.5%), and AUS (2.3% and 20%) (P < 0.001). Post-operative and 90 day complications were low., Conclusions: All three treatments seem to be safe among Medicare beneficiaries with multiple comorbidities. The urological, infectious, and neurological complication occurrences were low., (© 2014 Wiley Periodicals, Inc.)

Background: We aimed to determine the relationship between hospital volume and use of dual aortic and mitral valve surgical procedures., Methods: Patients who underwent both aortic and mitral valve repair or replacement during the same hospital stay were identified from the Nationwide Inpatient Sample (NIS). We compared patients' characteristics and in-hospital outcomes by the average annual center volume for multiple-heart valve surgical procedures, grouped into tertiles of patients with low (1 to 8), medium (9 to 18), and high (19+) volume categories using χ(2) tests and adjusted hierarchical logistic regression models., Results: From 1998 to 2011 an estimated total of 87,675 patients underwent combined aortic and mitral valve surgical procedures across the United States. Although most patients' characteristics were similar across volume groups, high-volume centers were more likely to treat older patients with coronary artery disease and to perform concomitant tricuspid valve operations. Low-volume centers replaced the aortic and mitral valves concomitantly more frequently with mechanical valves compared with high-volume centers (66.1% vs 45.5%), and this difference persisted across age groups. Compared with low-volume centers, the risk-adjusted odds ratios for in-hospital mortality at medium- and high-volume centers were 0.85 (95% confidence interval [CI]: 0.74 to 0.99) and 0.66 (95% CI: 0.55 to 0.80), respectively. No significant interaction was found between overall facility major cardiac surgery volume and multiple-valve procedure volume with respect to mortality (p = 0.143)., Conclusions: Hospital volume remains an important factor influencing risk-adjusted mortality after combined aortic and mitral valve surgical procedures. Hospitals that perform more than eight combined aortic and mitral heart valve operations demonstrate a superior statistical hospital survival compared with those that perform less than eight multiple-heart valve operations a year. Further policy interventions aimed to lower hospital mortality in low-volume centers may offer possibilities for quality improvement in the field of valve surgery., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background and Purpose: Endovascular coiling therapy is increasingly popular for obliteration of unruptured intracranial aneurysms, but older patients face higher procedural risks and shorter periods during which an untreated aneurysm may rupture causing subarachnoid hemorrhage (SAH). We assessed trends in clipping and coiling of unruptured intracranial aneurysms, outcomes after clipping and coiling of unruptured intracranial aneurysms, and in SAH among Medicare beneficiaries., Methods: Using 2000 to 2010 Medicare Provider Analysis and Review data, we identified 2 cohorts of patients admitted electively for clipping or coiling of an unruptured aneurysm: (1) utilization cohort (2000-2010): patients ≥65 years enrolled ≥1 month in a given year and (2) outcomes cohort (2001-2010): patients ≥66 years of age enrolled in Medicare for ≥1 year. We calculated rates of clipping, coiling, and SAH per 100 000 Medicare beneficiaries. We tested for trends in the risk of in-hospital mortality and complications, discharge destination, 30-day mortality, 30-day readmissions, and length of hospitalization., Results: Characteristics of patients undergoing clipping (n=4357) or coiling (n=7942) did not change appreciably. Overall, 30-day mortality, in-hospital complications, and 30-day readmissions decreased, generally reaching their lowest levels in 2008 to 2010 (1.6%, 25.0%, and 14.5% for clipping and 1.5%, 13.8%, and 11.0% for coiling, respectively). Procedural treatment rates per 100 000 beneficiaries increased from 1.4 in 2000 to 6.0 in 2010, driven mainly by increased use of coiling but SAH rates did not decrease., Conclusions: Although outcomes tended to improve over time, increased preventative treatment of unruptured intracranial aneurysms among Medicare beneficiaries did not result in a population-level decrease in SAH rates., (© 2015 American Heart Association, Inc.)

Background: Robotic-assisted mitral valve repair is becoming more frequently performed in cardiac surgery. However, little is known about its utilization and safety at a national level., Methods: Patients undergoing mitral valve repair in the United States from 2008 to 2012 were identified in the National Inpatient Sample. Inhospital mortality, complications, length of stay, and cost for patients undergoing robotic-assisted mitral valve repair were compared with patients undergoing nonrobotic procedures., Results: We identified 50,408 isolated mitral valve repair surgeries, of which 3,145 were done with robotic assistance. In a propensity score matched analysis of 631 pairs of patients, we found no difference between patients undergoing robotic-assisted and nonrobotic-assisted mitral valve repair with respect to inhospital mortality, complications, or composite outcomes in unadjusted or multivariable analyses. Robotic-assisted mitral valve repair surgery was associated with a shorter median length of stay (4 versus 6 days, p < 0.001), and there was no difference in median total costs between the two procedures., Conclusions: In our analysis of a large national database with its inherent limitations, robotic-assisted mitral valve repair was found to be safe, with an acceptable morbidity and mortality profile., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Substantial controversy surrounds the choice between a mechanical versus bioprosthetic prosthesis for aortic valve replacement (AVR), based on age. This study aims to investigate national trends and in-hospital outcomes of the 2 prosthesis choices., Methods: All patients aged >18 years in the National Inpatient Sample who received an AVR between 1998 and 2011 were considered. Valve-type use was examined by patient, procedural, and hospital characteristics, after which we matched patients based on their propensity score for receiving a bioprosthetic valve and compared their in-hospital outcomes., Results: Bioprosthetic valves comprised 53.3% of 767,375 implanted valves, an increase in use from 37.7% in the period 1998 to 2001 to 63.6% in the period 2007 to 2011. The median age was 74 years for patients receiving bioprosthetic valves, and 67 years for those receiving mechanical valves. Use of bioprosthetic valves increased across all age groups, most markedly in patients age 55 to 64 years. Compared with patients receiving mechanical valves, these patients had a higher incidence of renal disease (8.0% vs 4.2%), coronary artery disease (58.5% vs 50.5%), concomitant coronary artery bypass grafting (46.7% vs 41.9%), and having surgery in a high-volume (>250 cases per year) center (31.3% vs 18.5%). Patients receiving bioprosthetic valves had a higher occurrence of in-hospital complications (55.9% vs 48.6%), but lower in-hospital mortality (4.4% vs 4.9%) than patients receiving mechanical valves. This difference was confirmed in propensity-matched analyses (complications: 52.7% vs 51.5%; mortality: 4.3% vs 5.2%)., Conclusions: Use of bioprosthetic valves in AVR increased dramatically from 1998 to 2011, particularly in patients age 55 to 64 years. Prosthesis selection varied significantly by facility, with low-volume facilities favoring mechanical valves. Aortic valve replacement with a bioprosthetic valve, compared with a mechanical valve, was associated with lower in-hospital mortality., (Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

We performed an extended oral glucose tolerance test (OGTT) to investigate the relationship between early and late beta-cell response and type 2 diabetes (T2D) in families of South Asian origin and indigenous Dutch, burdened by T2D. Based on the OGTT, 22 individuals were normoglycemic, 12 glucose intolerant and 23 had T2D in the South Asian families; these numbers were 34, 12 and 18 in the Caucasian families, respectively. The OGTT had 11 blood samplings in 3.5 h for glucose, insulin and C-peptide measurements. Through early and late insulin secretion rate (ISR), the above basal glucose area-under-the-curve after glucose load (glucose disposal) and insulin sensitivity index (ISI), we obtained early and late disposition indices (DI). South Asians on average had lower ISI than Caucasians (3.8 ± 2.9 vs. 6.5 ± 4.7, respectively, P < 0.001), with rapid decline of their early and late DI between normal glucose tolerance versus impaired fasting glucose/impaired glucose tolerance (late DI; P < 0.0001). Adjusted for ISI, age, gender and waist-to-hip ratio, early ISR was significantly associated with glucose disposal in South Asians (β = 0.55[0.186; 0.920]), but not in Caucasians (β = 0.09[-0.257; 0.441]). Similarly, early ISR was strongly associated with late ISR (β = 0.71[0.291; 1.123]; R (2) = 45.5 %) in South Asians, but not in Caucasians (β = 0.27[-0.035; 0.576]; R (2) = 17.4 %), with significant interaction between ethnicity and early ISR (β = 0.341[0.018; 0.664]). Ordinal regression analyses confirmed that all South Asian OGTT subgroups were homogenously resistant to insulin and solely predicted by early ISR (β = -0.782[-1.922; 0.359], β = -0.020[-0.037; -0.002], respectively), while in Caucasian families both ISI and early ISR were related to glucose tolerance state (β = -0.603[-1.105; -0.101], β = -0.066[-0.105; -0.027], respectively). In South Asian individuals, rapid beta-cell deterioration might occur under insulin resistant conditions. As their early insulin response correlates strongly with both glucose disposal and late insulin response, alterations in beta-cell dynamics may give an explanation to their extreme early onset of T2D, although larger prospective studies are required.

Objective: To assess national trends of iatrogenic complications and associated burden of care among patients undergoing open and minimally invasive prostatectomy using a population-based cohort., Methods: Using the nationally representative cohort, we identified patients who were diagnosed with prostate cancer, and underwent prostatectomy during 2001 and 2011. We determined the risk of iatrogenic complication and length of stay (LOS) over time among open and minimally invasive surgery (MIS) patients. Hierarchical multivariable logistic regression was performed to assess the changes over time and elucidate independent predictors of iatrogenic complications., Results: We identified 556,932 and 219,434 prostate cancer patients undergoing open and minimally invasive prostatectomy. We found that iatrogenic complications for MIS were less frequent in later years (years 09-11 vs. year 01-02 odds ratio (OR), 0.21; 95% confidence intervals (CI), 0.09-0.40). MIS was associated with higher risk of iatrogenic complications in early period (years 01-02 OR, 3.81; 95% CI, 1.72-8.41), but lower risk in late period (years 09-11 OR 0.72 95% CI 0.61-0.86). Patients who experienced iatrogenic complications tended to have longer LOS (Median: Open vs. MIS, 4 days vs. 3 day) than those who didn't (Median: Open vs. MIS, 2 days vs. 1 day), regardless of procedure type., Conclusion: We found that minimally invasive prostatectomy is associated with lower risk of iatrogenic complications when compared with open surgery (OS). However, as "learning curve" is overcome over time, MIS becomes safer than OS. Iatrogenic complications are not benign and seem to be associated with higher burden of inpatient care.

Background: Fixation in total hip replacements remains a controversial topic, despite the high level of its success. Data obtained from major orthopaedic registries indicate that there are large differences among preferred fixation and survival results., Methods: Using a distributed registry data network, primary total hip arthroplasties performed for osteoarthritis from 2001 to 2010 were identified from six national and regional total joint arthroplasty registries. A multivariate meta-analysis was performed using linear mixed models with the primary outcome revision for any reason. Survival probabilities and their standard errors were extracted from each registry for each unique combination of the covariates. Fixation strategies were compared with regard to age group, sex, bearing, and femoral-head diameter. All comparisons were based on the random-effects model and the fixed-effects model., Results: In patients who were seventy-five years of age and older, uncemented fixation had a significantly higher risk of revision (p < 0.001) than hybrid fixation, with a hazard ratio of 1.575 (95% confidence interval, 1.389 to 1.786). We found a similar, if lesser, effect in the intermediate age group of sixty-five to seventy-four years (hazard ratio, 1.16 [95% confidence interval, 1.023 to 1.315]; p = 0.021) and in the younger age group of forty-five to sixty-four years (hazard ratio, 1.205 [95% confidence interval, 1.008 to 1.442]; p = 0.041). There were no significant differences between hybrid and cemented bearings across age groups., Conclusions: We conclude that cementless fixation should be avoided in older patients (those seventy-five years of age or older), although this evidence is less strong in patients of intermediate and younger ages., (Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.)

Background: Posterior-stabilized total knee prostheses were introduced to address instability secondary to loss of posterior cruciate ligament function, and they have either fixed or mobile bearings. Mobile bearings were developed to improve the function and longevity of total knee prostheses. In this study, the International Consortium of Orthopaedic Registries used a distributed health data network to study a large cohort of posterior-stabilized prostheses to determine if the outcome of a posterior-stabilized total knee prosthesis differs depending on whether it has a fixed or mobile-bearing design., Methods: Aggregated registry data were collected with a distributed health data network that was developed by the International Consortium of Orthopaedic Registries to reduce barriers to participation (e.g., security, proprietary, legal, and privacy issues) that have the potential to occur with the alternate centralized data warehouse approach. A distributed health data network is a decentralized model that allows secure storage and analysis of data from different registries. Each registry provided data on mobile and fixed-bearing posterior-stabilized prostheses implanted between 2001 and 2010. Only prostheses associated with primary total knee arthroplasties performed for the treatment of osteoarthritis were included. Prostheses with all types of fixation were included except for those with the rarely used reverse hybrid (cementless tibial and cemented femoral components) fixation. The use of patellar resurfacing was reported. The outcome of interest was time to first revision (for any reason). Multivariate meta-analysis was performed with linear mixed models with survival probability as the unit of analysis., Results: This study includes 137,616 posterior-stabilized knee prostheses; 62% were in female patients, and 17.6% had a mobile bearing. The results of the fixed-effects model indicate that in the first year the mobile-bearing posterior-stabilized prostheses had a significantly higher hazard ratio (1.86) than did the fixed-bearing posterior-stabilized prostheses (95% confidence interval, 1.28 to 2.7; p = 0.001). For all other time intervals, the mobile-bearing posterior-stabilized prostheses had higher hazard ratios; however, these differences were not significant., Conclusions: Mobile-bearing posterior-stabilized prostheses had an increased rate of revision compared with fixed-bearing posterior-stabilized prostheses. This difference was evident in the first year., (Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.)

The International Consortium for Orthopaedic Registries is a multinational initiative established by the United States Food and Drug Administration to develop a health data network aimed at providing a robust infrastructure to facilitate evidence-based decision-making on performance of medical devices. Through the International Consortium for Orthopaedic Registries, individual data holders have complete control of their data and can choose to participate in studies of their choice. In this article, we present an overview of the data extraction process and the analytic strategy employed to answer several device performance-related questions in total hip arthroplasty and total knee arthroplasty. In the process, we discuss some nuances pertinent to International Consortium for Orthopaedic Registries data that pose certain statistical challenges, and we briefly suggest strategies to be adopted to address them., (Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.)

Background: Robotic-assisted lobectomy is being offered increasingly to patients. However, little is known about its safety, complication profile, or effectiveness., Methods: Patients undergoing lobectomy in in the United States from 2008 to 2011 were identified in the Nationwide Inpatient Sample. In-hospital mortality, complications, length of stay, and cost for patients undergoing robotic-assisted lobectomy were compared with those for patients undergoing thoracoscopic lobectomy., Results: We identified 2,498 robotic-assisted and 37,595 thoracoscopic lobectomies performed from 2008 to 2011. The unadjusted rate for any complication was higher for those undergoing robotic-assisted lobectomy than for those undergoing thoracoscopic lobectomy (50.1% vs 45.2%, P < .05). Specific complications that were higher included cardiovascular complications (23.3% vs 20.0%, P < .05) and iatrogenic bleeding complications (5.0% vs 2.0%, P < .05). The higher risk of iatrogenic bleeding complications persisted in multivariable analyses (adjusted OR, 2.64; 95% CI, 1.58-4.43). Robotic-assisted lobectomy costs significantly more than thoracoscopic lobectomy ($22,582 vs $17,874, P < .05)., Conclusions: In this early experience with robotic surgery, robotic-assisted lobectomy was associated with a higher rate of intraoperative injury and bleeding than was thoracoscopic lobectomy, at a significantly higher cost.

Objective: To compare long term survival after minimally invasive lobectomy and thoracotomy lobectomy., Design: Propensity matched analysis., Setting: Surveillance, Epidemiology and End Results (SEER)-Medicare database., Participants: All patients with lung cancer from 2007 to 2009 undergoing lobectomy., Main Outcome Measure: Influence of less invasive thoracoscopic surgery on overall survival, disease-free survival, and cancer specific survival., Results: From 2007 to 2009, 6008 patients undergoing lobectomy were identified (n=4715 (78%) thoracotomy). The median age of the entire cohort was 74 (interquartile range 70-78) years. The median length of follow-up for entire group was 40 months. In a matched analysis of 1195 patients in each treatment category, no statistical differences in three year overall survival, disease-free survival, or cancer specific survival were found between the groups (overall survival: 70.6% v 68.1%, P=0.55; disease-free survival: 86.2% v 85.4%, P=0.46; cancer specific survival: 92% v 89.5%, P=0.05)., Conclusion: This propensity matched analysis showed that patients undergoing thoracoscopic lobectomy had similar overall, cancer specific, and disease-free survival compared with patients undergoing thoracotomy lobectomy. Thoracoscopic techniques do not seem to compromise these measures of outcome after lobectomy., (© Paul et al 2014.)

Objective: The goal of this curriculum was to train residents in measurement-based care (MBC)., Method: Third-year psychiatry residents were educated in MBC through didactic seminars and a quality-improvement (QI) initiative with the goal of implementing the Patient Health Questionnaire Depression Scale (PHQ-9) to screen and monitor patients for symptoms of depression., Results: Residents suggested strategies for integrating the PHQ-9 into the clinic. Over the first 6 months, residents showed an increase in rate of depression screening from 4% to 92% of patients. Also, they increased monthly monitoring of outpatients with a diagnosis of depression from 1% to 76%. Residents who used the PHQ-9 to monitor patients with depression were significantly more likely to use additional standardized assessments., Conclusions: Combining an educational intervention with QI strategies can significantly affect residents' use of standardized assessments in an outpatient setting. Using standardized measures allows residents to assess their own clinical effectiveness, an emerging priority in training.

The use of standardized patient assessments (SPAs) in psychiatry is an emerging best practice. This column describes a survey of resident and faculty supervisors at a large academic department examining current practices, attitudes, and perceived barriers to incorporating SPAs into clinical practice. Although the study found that SPAs were not routinely used in clinical practice or supervision, residents and faculty were fairly optimistic about their potential value. The results suggest that educational initiatives should be integrated into clinical practice, start early within training, include both trainees and faculty supervisors, and set use of SPAs as an expected standard of care.

Objectives: To evaluate and compare the effectiveness and cost-effectiveness of a leisure centre-based exercise programme, an instructor-led walking programme and advice-only in patients referred for exercise by their GPs., Design: A single-centre, parallel-group, randomised controlled trial, consisting of three arms, with the primary comparison at 6 months., Setting: Assessments were carried out at Copthall Leisure Centre in Barnet, an outer London borough, and exercise programmes conducted there and at three other leisure centres and a variety of locations suitable for supervised walking throughout the borough., Participants: Participants were aged between 40 and 74 years, not currently physically active and with at least one cardiovascular risk factor., Interventions: The 943 patients who agreed to participate in the trial were assessed in cohorts and randomised to one of the following three arms: a 10-week programme of supervised exercise classes, two to three times a week in a local leisure centre; a 10-week instructor-led walking programme, two to three times a week; an advice-only control group who received tailored advice and information on physical activity including information on local exercise facilities. After 6 months the control group were rerandomised to one of the other trial arms. Assessments took place before randomisation, at 10 weeks (in a random 50% subsample of participants), 6 months and 1 year in the leisure centre and walking arms. The control participants were similarly assessed up to 6 months and then reassessed at the same intervals as those initially randomised to the leisure centre and walking groups., Main Outcome Measures: The primary outcome measures were changes in self-reported exercise behaviour, blood pressure, total cholesterol and lipid subfractions. Secondary outcomes included changes in anthropometry, cardiorespiratory fitness, flexibility, strength and power, self-reported lifestyle behaviour, general and psychological health status, quality of life and health service usage. The costs of providing and making use of the service were quantified for economic evaluation., Results: There was a net increase in the proportion of participants achieving at least 150 minutes per week of at least moderate activity in the sport/leisure and walking categories in all three study groups: at 6 months, the net increases were 13.8% in the leisure centre group, 11.1% in the walking group and 7.5% in the advice-only group. There were significant reductions in systolic and diastolic blood pressure in all groups at each assessment point compared with baseline. There were also significant and sustained improvements in cardiorespiratory fitness and leg extensor power, and small reductions in total and low-density lipoprotein cholesterol in all groups, but there were no consistent differences between the groups for any parameter over time. All three groups showed improvement in anxiety and mental well-being scores 6 months after the beginning of the trial. Leisure centre and walking groups maintained this improvement at 1 year. There were no differences between groups. Costs to the participants amounted to pound 100 for the leisure centre scheme and pound 84 for the walking scheme, while provider costs were pound 186 and pound 92, respectively. Changes in overall Short Form 36 scores were small and advice only appeared the most cost-effective intervention., Conclusions: The results of this trial suggest that referral for tailored advice, supported by written materials, including details of locally available facilities, supplemented by detailed assessments may be effective in increasing physical activity. The inclusion of supervised exercise classes or walks as a formal component of the scheme may not be more effective than the provision of information about their availability. On cost-effectiveness grounds, assessment and advice alone from an exercise specialist may be appropriate to initiate action in the first instance. Subsidised schemes may be best concentrated on patients at higher absolute risk, or with specific conditions for which particular programmes may be beneficial. Walking appears to be as effective as leisure centre classes and is cheaper. Efforts should be directed towards maintenance of increased activity, with proven measures such as telephone support. Further research should include an updated meta-analysis of published exercise interventions using the standardised mean difference approach.

Functional metastatic adrenocortical carcinoma is an uncommon cause of Cushing's syndrome, which rarely responds to conventional treatment. A patient presenting with Cushing's syndrome secondary to adrenocortical carcinoma underwent surgical resection. Postoperatively, she developed metastatic disease resistant to conventional chemotherapy. Octreotide, a somatostatin analogue which is effective in the treatment of several types of neuroendocrine tumour, was tried to ameliorate her secretory symptoms, but without any therapeutic effect.

Metabolic disturbances associated with insulin resistance are present in most women with polycystic ovary syndrome. This has led to suggestions that women with polycystic ovary syndrome may be at increased risk of cardiovascular disease in later life. We undertook a long-term follow-up study to test whether cardiovascular mortality is increased in these women. A total of 786 women diagnosed with polycystic ovary syndrome in the United Kingdom between 1930 and 1979 were traced from hospital records and followed for an average of 30 years. Standardized mortality ratios (SMRs) were calculated to compare the death rates of these women with national rates. The SMR for all causes was 0.90 (95% CI, 0.69-1.17), based on 59 deaths. There were 15 deaths from circulatory disease, yielding an SMR of 0.83 (95% CI, 0.46-1.37). Of these 15 deaths, 13 were from ischemic heart disease (SMR 1.40; 95% CI, 0.75-2.40) and two were from other circulatory disease (SMR 0.23; 95% CI, 0.03-0.85). There were six deaths from diabetes mellitus as underlying or contributory cause, compared with 1.7 expected (odds ratio 3.6; 95% CI, 1.5-8.4). Breast cancer was the commonest cause of death (SMR 1.48 based on 13 deaths; 95% CI, 0.79-2.54). We conclude that women with polycystic ovary syndrome do not have markedly higher than average mortality from circulatory disease, even though the condition is strongly associated with diabetes, lipid abnormalities, and other cardiovascular risk factors. The characteristic endocrine profile of women with polycystic ovary syndrome may protect against circulatory disease in this condition.

Study Objectives: To ascertain the determinants and experiences of hormone replacement therapy (HRT) use by menopausal women doctors., Design: Postal questionnaire., Setting: UK., Patients: A randomized stratified sample of women doctors who obtained full registration between 1952 and 1976, taken from the current Principal List of the UK Medical Register., Main Outcome Measures: Current and previous use of HRT; reasons for and against HRT use; menopausal status; hormonal contraceptive use; lifestyle patterns; family and personal history of disease., Main Results: While 73.2% of 471 users had started HRT for symptom relief, 60.9% cited prevention of osteoporosis and 32.7 prevention of cardiovascular disease. Altogether 18.7% had started for preventive purposes alone. Significant predisposing factors to starting HRT were the presence and severity of menopausal symptoms, surgical menopause, past use of hormonal contraception, and a family history of osteoporosis. HRT users were also more likely to use skimmed rather than full fat milk, to try to increase their intake of fruit, vegetables, and fibre, and to undertake vigorous physical activity at least once a week. They were less likely to have had breast cancer. Long duration users were more likely than short duration users to be past users of hormonal contraception and to be using HRT for prevention of osteoporosis as well as symptom relief; they were less likely to have experienced side effects., Conclusions: The high usage of HRT by women doctors reflects the fact that many started HRT on their own initiative and with long term prevention in mind. The results may become generalisable to the wider population as information on the potential benefits of HRT is disseminated and understood. However, HRT users may differ slightly from non-users in health-related behaviour and a substantial minority may never take up HRT, at least until the benefit-risk ratio is more clearly established.

A community-based survey was undertaken to ascertain current hormone replacement therapy (HRT) prescription rates in postmenopausal diabetic women. From age/sex and disease registers linked to prescription data which covered 144,237 patients, details on 6867 women aged 50-60 years were obtained. Of this group, 1684 (24.5%) were receiving prescriptions for HRT; the comparable figures for the 537 patients with hypertension and 135 (insulin-dependent and non-insulin dependent) diabetic patients were 117 (21.8%) and 15 (11.1%) respectively. While the presence of hypertension did not affect the likelihood of being prescribed HRT (odds ratio 0.85 [95% CI 0.68-1.05], p > 0.1), women with diabetes were less than half as likely as those from the general population to be prescribed HRT (odds ratio 0.38 [95% CI 0.21-0.67], p < 0.001). These data indicate that proportionately greater numbers of postmenopausal diabetic women, even compared with those with hypertension, another group at high risk of cardiovascular disease, are denied the potential benefits of HRT.

Objectives: To ascertain the prevalence and duration of use of hormone replacement therapy by menopausal women doctors., Design: Postal questionnaire., Setting: General practices in the United Kingdom., Subjects: Randomised stratified sample of women doctors who obtained full registration between 1952 and 1976, taken from the current principal list of the Medical Register., Main Outcome Measures: Prevalence and duration of use of hormone replacement therapy; menopausal status., Results: Overall, 45.7% (436/954) of women doctors aged between 45 and 65 years had ever used hormone replacement therapy. When the results from women still menstruating regularly were excluded, 55.2% (428) were ever users and 41.2% (319) current users. The cumulative probability of remaining on hormone replacement therapy was 0.707 at five years and 0.576 at 10 years., Conclusions: Women doctors have a higher prevalence of use of hormone replacement therapy than has been reported for other women in the United Kingdom, and most users seem to be taking hormone replacement therapy for more than five years. The results may become generalisable to the wider population as information on the potential benefits of hormone replacement therapy is disseminated.

A luteinizing hormone/follicle-stimulating hormone-releasing hormone (LH/FSH-RH) test was performed in 70 women with amenorrhoea or anovulatory infertility, or both, and a clomiphene stimulation test was also performed in 24 of these patients. Most patients responded to LH/FSH-RH with significant increases in LH and FSH. In women with gonadal dysgenesis or premature ovarian failure exaggerated responses were observed after LH/FSH-RH and there was no change in high basal LH levels after clomiphene. Patients with absent or impaired responses to LH/FSH-RH failed to respond to clomiphene. All patients with anovulatory menstrual cycles responded to both LH/FSH-RH and clomiphene, while seven out of 13 amenorrhoeic patients with a normal LH/FSH-RH response showed an early LH rise during clomiphene treatment and six were unresponsive. These results suggest a difference between the two groups at hypothalamic level with consequent therapeutic implications.

A 37-year-old female, weighing 194.1 kg, is described. Her gross obesity was in part due to a massive ovarian dermoid cyst weighing at least 42 kg, which had been overlooked in the past. A dermoid tumour of this size has not previously been reported. The possible presence of cystic ovarian tumours should be considered in patients presenting with severe generalized obesity.

Serum levels of gonadotrophins and prolactin and their response to luteinizing hormone/follicle stimulating hormone--releasing hormone (LRH) and thyrotrophin releasing hormone (TRH) were measured in 14 females with anorexia nervosa when at low body weight and again in 6 cases during, and 12 cases after weight gain. Mean serum luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels were low initially and whereas FSH increased significantly with weight gain, LH levels remained subnormal in most patients. LH responses to LRH were grossly impaired or absent in patients whose weight was below 75% of the ideal, but increased dramatically above this weight over-shadowing the more modest increase in FSH response. In three patients, however, impaired LH responses persisted as ideal weight was approached. Basal prolactin levels were well within the normal range in all patients. During weight gain there was no change in basal levels but the prolactin level 20 min after TRH was significantly increased.

Between April and October 1983, 443 subjects were offered a month's course of Modifast by their general practitioners. Modifast is a very low calorie formula diet containing 1.7MJ (410 kcal) and 70g protein per day. Results available on 335 of these individuals indicate that 217 completed a four week course and achieved an average weight loss of 6.6 kg, whilst those that did not complete the course achieved a 2.6 kg weight loss. Concurrent disease was present in 44.5% of subjects. The product was rated on average, tolerable, but side effects, albeit generally minor and transient, were reported by one third. Nearly two-thirds of the initially hypertensive patients became normotensive. Modified fasting is an acceptable and effective initial approach to weight loss in general practice.

The UK Licensing Authority, aided by advice from expert committees, has the statutory duty to evaluate new medicines in respect of quality, safety and efficacy. All drug applications in the EC must now be accompanied by a summary of product characteristics which includes a statement on the effects of the products on the ability to drive and operate machinery. Any claims or warnings made in this or other respects must be based on data resulting from scientific experiments and will appear in data sheets. Appropriate label warnings may also be required, in some cases imposed by the Labelling Regulations, such as the standard antihistamine warning. The use of package inserts to give further warning to the public is currently under study.

Twenty menopausal women and 2 women with gonadal dysgenesis were treated with piperazine oestrone sulphate 1.5-3 mg dialy on a cyclical basis for a period of 6 months. Fasting serum lipids and lipoprotein esterified fatty acid indices (EFI) were estimated before starting treatment and after 3 and 6 months. There were small falls in serum cholesterol (significant at 3 months) and beta-lipoprotein EFI (significant at 6 months). Serum triglyceride and pre-beta-lipoprotein EFI rose significantly at both 3 and 6 months. Serum total phospholipid levels were reduced (significant at 6 months) with most marked changes in the sphingomyelin fraction. Other parameters were not significantly altered.

The functional state of the hypothalamo-pituitary-thyroid axis was assessed in 14 women and girls with anorexia nervosa when at low body weight and again in 12 cases after they had gained weight. Mean serum thyroxine concentrations were low before and after weight gain. Mean serum triiodothyronine (T3) concentrations were substantially reduced at low weight and doubled after weight gain, the absolute values being linearly correlated with body weight expressed as a percentage of the ideal. Concentrations of reverse T3 were greatly increased in some patients initially and fell with weight gain. Basal concentrations of thyroid-stimulating hormone (TSH) were unchanged after weight gain but the TSH response to thyrotrophin-releasing hormone was significantly augmented; delayed patterns of response were found in seven out of 12 patients tested before and three out of 12 patients tested after weight gain. Changes in the hypothalamo-pituitary-thyroid axis are common in anorexia nervosa and probably represent both peripheral and central adaptations to the altered nutritional state.

A group of 149 diabetics and 98 healthy subjects without evidence of diabetes or ischaemic heart disease were studied. Untreated diabetics under 40 years old and 40 years of age and over showed statistically raised fasting serum turbidity, triglycerides, and raised beta and pre-beta lipoprotein levels but not raised cholesterol levels over the age and sex matched normal subjects. Further, some 63% of all diabetics showed a distinct split pre-beta lipoprotein pattern as seen on polyacrylamide disc electrolphoresis as compared with 17% in the control group. Raised lecithin and phosphatidylethanolamine (PE) levels were found in male diabetics and raised PE levels in young diabetic women. In patients under treatment with insulin, chlorpropamide, or phenformin the diabetes was well controlled in most cases, but these patients did not have significantly lower lipid levels. Diabetics on a low carbohydrate diet showed improvement in triglycerides and pre-beta lipoprotein levels, but beta lipoproteins were not lowered. It is suggested that diabetics may benefit by the inclusion of clofibrate in the treatment.

Thirty-three post-menopausal women were treated with piperazine oestrone sulphate 1.5--3.0 mg daily on a cyclical basis for 3--6 months. Serum luteinising hormone (LH), follicle-stimulating hormone (FSH), oestrone and oestradiol were measured on two occassions prior to starting treatment, and several times during the course of therapy. Initial mean concentrations of oestrone and oestradiol of 59 and 14 pg/ml rose to 528 and 83 pg/ml, respectively, and this was associated with a dose-related suppression of LH (from 57.1 to 50.3 u/l) and more particularly FSH (from 25.8 to 16.5 u/l). There was a highly significant correlation between the decrease in FSH and the oestradiol concentration during treatment, but no correlation with oestrone.