Sacral Resections for Primary Sacral Tumor - an Experience from a Tertiary Care Cancer Center in India.

Primary sacral tumors are uncommon and sacrectomy is a complex surgical procedure with substantial risk of morbidity. We conducted a retrospective study of patients who had undergone sacral resections for primary sacral tumors between 2010 and 2020. Ten sacral resections including five type 1 sacrectomy (S1 resected), four type 2 (S1 spared), and one type 3 (S3 spared) were performed during the above period. The median age was 47 years and the most common histologic diagnosis was chordoma (50%). The median operating time was 705 min (range 180-960 min) with a median blood loss of 3400 ml (range 500-7000 ml) and a median duration of hospital stay of 13.5 days (range 7-68 days). All patients who underwent type 1 sacrectomy experienced major complications (Clavien-Dindo grade 3 or above) including one death in the immediate perioperative period. Microscopically positive margins (R1) were noted in two patients (20%). All patients with type 1 sacrectomy had R0 resection. The median follow-up period was 31 months. The median MSTS score was 12 (range 4-27). A total of seven patients (70%) had a minimum follow-up of 2 years without disease recurrence. Sacral resection for primary tumors of the sacrum with oncologically safe margins is feasible. Although associated with substantial perioperative morbidity, a detailed preoperative planning and execution of the surgery by a team of orthopedic oncosurgeon, surgical oncologist, and plastic surgeon offer a hope for survival in patients with acceptable functional outcome.

Sexually Transmitted Infection Risks and Symptoms Heightened Among Female Sex Workers who Started Selling Sex Before the Age of 18 in Five Cities in Cameroon.

Many adolescents under 18 years old who sell sex are at elevated risk for sexually transmitted infection (STI) acquisition, which may persist into adulthood. There has been limited study of the burden of the risks and vulnerabilities among women who started selling sex as adolescents across Sub-Saharan Africa. In this study, a Adult female sex workers (FSW) recruited through respondent-driven sampling in five cities in Cameroon from December 2015 to October 2016 completed a questionnaire and human immunodeficiency virus (HIV) and syphilis testing. Multivariable logistic regression analysis controlling for age was used to identify factors associated with reporting selling sex before age 18. Selling sex before age 18 was reported by 11.5% (256/2,220) of FSW. Initiation of selling sex as an adolescent was positively associated with experiencing dysuria (adjusted odds ratio [aOR]:1.50, 95% confidence interval [CI]:1.08-2.10) or genital warts (aOR:1.78, 95% CI:1.08-2.94) and negatively associated with prior recent testing for HIV (aOR:0.71, 95% CI:0.53-0.96) or STIs (aOR:0.65, 95% CI:0.44-0.96). Consistent condom use with clients was negatively associated with early initiation of selling sex (aOR:0.58, 95% CI:0.42-0.80), while experience of recent sexual violence was positively associated with early initiation (aOR:1.74, 95% CI:1.15-2.63). There were no independent significant differences in HIV (24.5%) or syphilis (8.3%) prevalence. Given the limited use of HIV and STI testing services by women who sold sex as adolescents, the prevalence of forced sex, condomless sex, and STI symptoms were high. Programs serving FSW should more vigorously aim to serve adolescents and adults who began selling sex early.

Antiretroviral Treatment-Induced Galectin-9 Might Impact HIV Viremia in Addition to Contributing to Inflammaging.

BACKGROUND: Galectin-9 induces HIV reactivation and also contributes to non-AIDS events through inflammaging. Hence, it is important to assess its levels in HIV-infected individuals to determine their association with HIV viremia and other comorbidities. METHODS: Plasma galectin-9 levels were estimated in viremic (n = 152) and aviremic (n = 395) individuals on first-line antiretroviral therapy (ART). They were assessed for correlation with HIV-1 viral load (VL), CD4 count, and ART duration, as well as for receiver operating characteristic curve analysis. RESULT: Plasma galectin-9 levels correlated positively with VL (r = 0.507, p < 0.0001) and ART duration (r = 0.308, p = 0.002) and negatively with CD4 count (r = -0.186, p < 0.0001). Area under the curve for galectin-9/CD4 count ratio for identifying viremic individuals was 0.906. Sensitivity and specificity of the ratio at a cutoff of 14.47 were 90.13% and 70.05%, respectively, for detecting viremic individuals. Further, galectin-9 levels correlated with cystatin C (r = 0.239, p = 0.0183), IL-18 (r = 0.311, p = 0.006), and systolic blood pressure (r = 0.220, p = 0.0355). Galectin-9-induced HIV reactivation was significantly lower in individuals on long-term ART than those on short-term ART. CONCLUSION: The galectin-9-to-CD4 count ratio indicated the potential of galectin-9 as a cheaper monitoring tool to detect HIV viremia. Strategies for countering the effects of galectin-9 for controlling HIV viremia and non-AIDS events are urgently warranted.

Acceptability of HIV oral self-test among truck drivers and youths: a qualitative investigation from Pune, Maharashtra.

BACKGROUND: Ending AIDS by 2030 is a global target, to which India is a signatory. HIV-self-test (HIVST) coupled with counselling and AIDS-care, including antiretroviral therapy, has the potential to achieve this. However, national programs are at varying stages of acceptance of HIVST, as discussions around its introduction spark controversy and debates. HIV-self-test, as yet, is not part of the AIDS control program in India. Against this backdrop, we explored acceptability of an HIV oral self-test (HIVOST) among truckers and young men and women. METHODS: A qualitative investigation with 41 in-depth-interviews and 15 group discussions were conducted in the district of Pune, in the western state of Maharashtra, India. These interactions were built around a prototype HIVOST kit, helped in taking the discussions forward. The software N-vivo (version 11.0) was used to manage the volumes of data generated through the aforementioned process. The study was conducted during June through December, 2019. RESULTS: While the truckers belonged to the age bracket 21-67 year, the youths were in the age group 18-24 year. 'Ease of doing HIVOST' and 'fear of needle pricks' were the reasons behind acceptance around HIVOST by both the study groups. Truckers felt that HIVOST would encourage one to know one's HIV status and seek help as appropriate. Accuracy of HIVOST result and disposal of the kits following use were concerns of a few. Most of the participants preferred saliva over blood as the specimen of choice. Instructions in local language reportedly would enable test-use by self. The truck drivers preferred undertaking HIVOST at the truckers-friendly 'Khushi clinics' or in the vehicle, while youths preferred the privacy of home. Some of the young men mis-perceived the utility of HIVOST by referring to doing a test on a partner immediately prior to sexual encounter. On the other hand, a few truckers had wrong information on HIV cure. CONCLUSIONS: Overall, the study communities expressed their acceptance towards HIV-self-test. The National AIDS Control Program, India would benefit by drawing upon the findings of the current investigation. Existing myths and misconceptions around HIV test and treatment require program attention.

Impact of Surgery on Extramammary Paget's Disease Vulva: a Case Series.

Extramammary Paget's disease is a rare neoplasm that may affect the vulva. It usually presents as a pruritic red eczematous lesion with islands of hyperkeratosis that is often mistaken for other benign conditions. There are no specific guidelines for the management of this disease. Surgical excision is the standard treatment but recurrences are common in spite of extensive surgery with negative margins. We report here a series of 7 cases of Paget's disease vulva treated by primary surgery. The series highlights some of the challenges in the diagnosis and management of Paget's disease vulva.

Unsterile injection equipment associated with HIV outbreak and an extremely high prevalence of HCV-A case-control investigation from Unnao, India.

The integrated counseling and testing center (ICTC) located in the district hospital, Unnao in the northern state of Uttar Pradesh (UP), India witnessed an increased detection of HIV among its attendees in July 2017. Subsequently, health camps were organized by the UP State AIDS Control Society in the villages and townships contributing to such detection. We conducted a case-control study to identify factors associated with this increased detection; 33 cases and 125 controls were enrolled. Cases were individuals, detected HIV sero-reactive during November 2017-April 2018 from three locations namely Premganj, Karimuddinpur and Chakmeerapur in the Bangarmau block of the district of Unnao. Controls hailed from the same geographical setting and tested HIV sero-nonreactive either in health camps or at ICTC centers from where the cases were detected. Misclassification bias was avoided by confirming HIV sero-status of both cases as well as controls prior to final analysis. Study participants were interviewed on various risk practices and invasive treatment procedures. They were also tested for HIV and other bio-markers reflecting unsafe injecting and sexual exposures such as hepatitis B surface antigen (HBsAg), anti-HCV antibody (HCV Ab), anti-herpes simplex-2 Immunoglobulin G (HSV-2 IgG) and rapid plasma regain (RPR) test for syphilis. Secondary data analysis on three time points during 2015 through 2018 revealed a rising trend of HIV among attendees of the ICTCs (ICTC-Hasanganj, ICTC-Unnao district hospital and ICTC- Nawabganj) catering to the entire district of Unnao. While there was a seven fold rise of HIV among ICTC attendees of Hasanganj (χ2 value for trend 23.83; p < 0.001), the rise in Unnao district hospital was twofold (χ2 value for trend 4.37; p < 0.05) and was tenfold at ICTC-Nawabganj (χ2 value for trend 5.23; p < 0.05) indicating risk of infection prevailing throughout the district. Primary data was generated through interviews and laboratory investigations as mentioned above. The median age of cases and controls was 50 year (minimum 18 -maximum 68; IQR 31-57) and 38 year (minimum 18 -maximum 78; IQR 29-50) respectively. Thirty six percent of the cases and 47% of controls were male. A significantly higher proportion of cases (85%) had HCV Ab compared to controls (56%; OR 4.4, 95% CI 1.5-12.1); none reported injection drug use. However, cases and controls did not differ significantly regarding presence of HSV-2 IgG (6% versus 8% respectively). Neither any significant difference existed between cases and controls in terms of receiving blood transfusion, undergoing invasive surgical procedures, tattooing, tonsuring of head or skin piercing. In multivariate logistic regression model, 'unsafe injection exposure during treatment-seeking'(AOR 6.61, 95% CI 1.80-24.18) and 'receipt of intramuscular injection in last five years' (AOR 7.20, 95% CI 1.48-34.88) were independently associated with HIV sero-reactive status. The monophyletic clustering of HIV sequences from 14 cases (HIV-1 pol gene amplified) indicated a common ancestry. Availability of auto-disabled syringes and needles, empowerment of the local communities and effective regulatory practices across care settings would serve as important intervention measures in this context.

Evaluating the vertical HIV transmission risks among South African female sex workers; have we forgotten PMTCT in their HIV programming?

BACKGROUND: Female sex workers (FSW) have a greater HIV burden compared to other reproductive-aged women and experience high incidence of pregnancies. However, there are limited data on mother-to-child transmission of HIV in the context of sex work. This study assessed the uptake of prevention of mother-to-child transmission (PMTCT) services to understand the vertical HIV transmission risks among FSW in South Africa. METHODS: FSW ≥18 years were recruited into a cross-sectional study using respondent-driven sampling (RDS) between October 2014-April 2015 in Port Elizabeth, South Africa. An interviewer-administered questionnaire captured information on demographics, reproductive health histories, and HIV care, including engagement in PMTCT care and ART. HIV and pregnancy testing were biologically assessed. This analysis characterizes FSW engagement in HIV prevention and treatment cascades of the four prongs of PMTCT. RESULTS: Overall, 410 FSW were enrolled. The RDS-weighted HIV prevalence was 61.5% (95% bootstrapped confidence interval 54.1-68.0). A comprehensive assessment of the four PMTCT prongs showed gaps in cascades for each of the prongs. In Prongs 1 and 2, gaps of 42% in consistent condom use with clients among HIV-negative FSW and 43% in long-term high efficacy contraceptive method use among HIV-positive FSW were observed. The analyses for prongs three and four pertained to 192 women with children < 5 years; 101/192 knew their HIV diagnosis prior to the study, of whom 85% (86/101) had their children tested for HIV after birth, but only 36% (31/86) of those who breastfed retested their children post-breastfeeding. A substantial proportion (35%, 42/120) of all HIV-positive women with children < 5 years of age were HIV-negative at their last delivery and seroconverted after delivery. Less than half (45%) of mothers with children < 5 years (45/101) were on ART and 12% (12/101) reported at least one child under five living with HIV. CONCLUSION: These findings show significant gaps in engagement in the PMTCT cascades for FSW, evidenced by sub-optimal uptake of HIV prevention and treatment in the peri/post-natal periods and insufficient prevention of unintended pregnancies among FSW living with HIV. These gaps result in elevated risks for vertical transmission among FSW and the need for PMTCT services within FSW programs.

Predictors of early childhood HIV testing among children of sex workers living with HIV in Cameroon.

BACKGROUND: Despite recent progress, there exist gaps in the prevention of vertical HIV transmission program access and uptake in Cameroon. Female sex workers (FSW), many of whom are mothers, are disproportionately affected by HIV and have specific barriers to HIV testing and treatment access. Testing for HIV-exposed infants is crucial in monitoring for incident infection and timely intervention. This study explores the level of early childhood testing and also associations between antenatal care (ANC) attendance and other factors and early childhood HIV testing among FSW in Cameroon. METHODS: FSW were recruited to participate in an integrated biobehavioral survey in Cameroon between December 2015 and October 2016. Women were included in these analyses if they were living with HIV and had at least one living child. Both univariate and multivariable logistic regression were used to look at predictors of a child being tested for HIV before age five. RESULTS: A total of 481/2255 FSW were eligible for these analyses as they were HIV seropositive and had at least one living child at the time of the study. Women included in these analyses had a median age of 35(IQR 30-41). Nearly 70% reported none of their children had been tested for HIV before age five (326/481), and 3.5%(17/481) reported one or more of their children had been diagnosed with HIV. ANC attendance (adjusted OR 2.12, 95% CI: [1.02, 4.55]), awareness of HIV status (aOR 3.70[2.30, 5.93]), pregnancy intentions (aOR 1.89[1.16, 3.08]), and higher education (aOR 2.17[1.01, 4.71]) were all independently associated with increased odds of women having a greater proportion of children tested for HIV before age five. Regional differences in early childhood testing were also observed. CONCLUSION: Vertical transmission of HIV remains a challenge in Cameroon, and HIV testing among children of FSW living with HIV was very low. ANC attendance and promotion of the mother's health were associated with increased child HIV testing. For women at high risk of HIV and for whom engagement in the health system is low, strategies to promote and ensure ANC attendance are essential for their health and the health of their children.

Antenatal care presentation and engagement in the context of sex work: exploring barriers to care for sex worker mothers in South Africa.

BACKGROUND: Late presentation combined with limited engagement in antenatal care (ANC) increases risk of vertical transmission among mothers living with HIV. Female sex workers (FSW) have more than four times greater burden of HIV than other women of reproductive age in South Africa and the majority of FSW are mothers. For mothers who sell sex and are at increased HIV acquisition risk, timely and routine ANC seeking is especially vital for prevention of vertical transmission. This study represents a mixed-methods study with FSW in Port Elizabeth, South Africa, to characterize factors influencing ANC seeking behaviors in a high HIV prevalence context. METHODS: FSW (n = 410) were recruited into a cross-sectional study through respondent-driven sampling between October 2014 and April 2015 and tested for HIV and pregnancy. A sub-sample of pregnant and postpartum women (n = 30) were invited to participate in in-depth interviews (IDIs) to explore their current or most recent pregnancy experiences. IDIs were coded using a modified grounded theory approach and descriptive analyses assessed the frequency of themes explored in the qualitative analysis among the quantitative sample. RESULTS: In the quantitative survey, 77% of FSW were mothers (313/410); of these, two-thirds were living with HIV (212/313) and 40% reported being on antiretroviral therapy (ART) (84/212). FSW in the qualitative sub-sample reported unintended pregnancies with clients due to inconsistent contraceptive use; many reported discovering their unintended pregnancies between 4 and 7 months of gestation. FSW attributed delayed ANC seeking and ART initiation in the second or third trimesters to late pregnancy detection. Other factors limiting engagement in ANC included substance and alcohol use and discontent with previous healthcare-related experiences. CONCLUSIONS: Late pregnancy discovery, primarily because pregnancies were unplanned, contributed to late ANC presentation and delayed ART initiation, increasing risks of vertical HIV transmission. Given limited ART coverage among participants, addressing the broader sexual and reproductive health and rights needs of mothers who sell sex has important implications for preventing vertical transmission of HIV. Integrating comprehensive family planning services into FSW programming, as well as providing active linkage to ANC services may reduce barriers to accessing timely ANC, decreasing risks of vertical transmission.

Community Breast Health Education for Immigrants and Refugees: Lessons Learned in Outreach Efforts to Reduce Cancer Disparities.

Community-academic partnerships are vital to address cancer disparities in geographic areas with diverse socioeconomic, language, and cultural barriers. Regarding breast health, immigrant and refugee women are a particularly vulnerable population, with considerably lower mammography rates than most communities, including racial and ethnic minorities. To promote health care equity in this high-risk population, we developed a community-academic partnership (CAP) model to promote breast health education at community faith-based centers in the city of Milwaukee, WI. In this paper, we describe the success of our partnerships, our lessons learned, and future directions.

Increasing Mammography Uptake Through Academic-Community Partnerships Targeting Immigrant and Refugee Communities in Milwaukee.

INTRODUCTION: Milwaukee, a city characterized by high rates of racial segregation and a growing immigrant population, has large race-based breast cancer survival disparities. To address these disparities, breast health education workshops were offered through a community-academic partnership (CAP) to women from various ethnic backgrounds. This paper explores attendance, satisfaction, and rates of screening mammography among workshop attendees. METHODS: Partnerships were formed with community-based organizations, a mobile mammography unit, and the Wisconsin Well Woman Program, a state-supported program providing free mammograms. Multilingual staff provided monthly breast health education workshops at community settings and coordinated transportation. Participants completed surveys that included demographics, prior screening history, barriers to screening, and program evaluation. Descriptive statistics were used to summarize and analyze data. RESULTS: Over a 24-month period, 493 women-most of whom sought services at partnering organizations that serve primarily immigrants, refugees, and racial minorities-attended breast health workshops, with 374 participants completing surveys (mean age = 45 years). A total of 360 were ≥ 40 years old. Among these women, 188 (113 insured [60%], 75 uninsured [40%]) reported no prior mammogram in the past 2 to 5 years. After attending the workshop, mammogram uptake was 100% among the insured and 80% among the uninsured. Satisfaction with the workshops was high; 73% of attendees rated them highly informative. CONCLUSIONS: Our CAP offered culturally tailored breast health education and access to screening via a mobile unit that was well attended, highly rated, and increased screening mammography.

Preoperative Incidence of Deep Venous Thrombosis in Patients With Bladder Cancer Undergoing Radical Cystectomy.

OBJECTIVE: To determine the preoperative incidence of subclinical lower-extremity deep vein thrombosis (DVT), as well as to evaluate the utility of preoperative DVT screening in patients with bladder cancer before undergoing radical cystectomy. MATERIALS AND METHODS: Beginning in 2014, we prospectively instituted a policy of obtaining a screening lower-extremity duplex ultrasound on all patients within 7 days before undergoing radical cystectomy. We reviewed the electronic medical records of all patients at our institution who underwent radical cystectomy for bladder cancer from January 2012 through December 2015. The screened group (n = 65) underwent preoperative screening; the historical control group (n = 78) did not. Primary outcome was a lower-extremity duplex ultrasound positive screening. Secondary outcome measures included the development of symptomatic venous thromboembolism (VTE) postoperatively, and the rate and severity of complications. RESULTS: DVT was identified in 13.9% of patients before undergoing cystectomy. Univariate analysis demonstrated an increased risk of subclinical DVT in patients who were exposed to neoadjuvant chemotherapy (35.3% vs 5.1%, P = .008). Postoperatively, there was a nonsignificant trend of lower DVT rate in the screened group compared to historical control. Overall complication rate and severity were similar between the groups. CONCLUSION: Subclinical DVT is present in a significant number of pre-cystectomy patients, especially those exposed to neoadjuvant chemotherapy. Ultrasound screening in patients before undergoing radical cystectomy may identify opportunities for early intervention to reduce morbidity and mortality associated with perioperative DVT or venous thromboembolism in the cystectomy population.

Knob protein enhances epithelial barrier integrity and attenuates airway inflammation.

BACKGROUND: Altered epithelial physical and functional barrier properties along with TH1/TH2 immune dysregulation are features of allergic asthma. Regulation of junction proteins to improve barrier function of airway epithelial cells has the potential for alleviation of allergic airway inflammation. OBJECTIVE: We sought to determine the immunomodulatory effect of knob protein of the adenoviral capsid on allergic asthma and to investigate its mechanism of action on airway epithelial junction proteins and barrier function. METHODS: Airway inflammation, including junction protein expression, was evaluated in allergen-challenged mice with and without treatment with knob. Human bronchial epithelial cells were exposed to knob, and its effects on expression of junction proteins and barrier integrity were determined. RESULTS: Administration of knob to allergen-challenged mice suppressed airway inflammation (eosinophilia, airway hyperresponsiveness, and IL-5 levels) and prevented allergen-induced loss of airway epithelial occludin and E-cadherin expression. Additionally, knob decreased expression of TH2-promoting inflammatory mediators, specifically IL-33, by murine lung epithelial cells. At a cellular level, treatment of human bronchial epithelial cells with knob activated c-Jun N-terminal kinase, increased expression of occludin and E-cadherin, and enhanced epithelial barrier integrity. CONCLUSION: Increased expression of junction proteins mediated by knob leading to enhanced epithelial barrier function might mitigate the allergen-induced airway inflammatory response, including asthma.

Tolerability of Repeat Use of Blue Light Cystoscopy with Hexaminolevulinate for Patients with Urothelial Cell Carcinoma.

PURPOSE: Hexaminolevulinate hydrochloride with blue light cystoscopy is approved by the U.S. Food and Drug Administration as an adjunct to white light cystoscopy for the detection of urothelial cell carcinoma. In this study we examined the tolerability of the repeat use of white light cystoscopy with blue light cystoscopy. MATERIALS AND METHODS: We retrospectively reviewed the records of all patients who underwent white light cystoscopy with blue light cystoscopy using hexaminolevulinate hydrochloride during a 34-month period at 2 institutions. We compared the incidence of adverse events after initial and subsequent procedures. We grouped, graded and assigned the degree of attribution for all adverse events. RESULTS: A total of 180 patients underwent 269 white light cystoscopy with blue light cystoscopy procedures. Of those 180 patients 118 (65%) underwent white light cystoscopy with blue light cystoscopy only 1 time. The other 62 (35%) patients underwent white light cystoscopy with blue light cystoscopy 2 or more times, including 43 (24%) 2 times and 19 (10%) 3 or more times. We noted 89 adverse events out of 269 procedures (33%), of which 66 (74%) occurred after the first white light cystoscopy with blue light cystoscopy; 14 (16%) after the second time and 9 (10%) after the third time or more. We found no statistically significant difference in adverse events between those patients undergoing 1 vs 2 or more white light cystoscopy with blue light cystoscopy procedures (p=0.134). We observed 1 grade 3 adverse event and no grade 4 or 5 adverse events. None of the adverse events were classified as probably or definitely related to hexaminolevulinate hydrochloride. CONCLUSIONS: In this retrospective study we found no statistically significant difference in the frequency or the grade of adverse events between first and repeat use of white light cystoscopy with blue light cystoscopy using hexaminolevulinate hydrochloride.

High-fat diet promotes lung fibrosis and attenuates airway eosinophilia after exposure to cockroach allergen in mice.

Obesity is an important risk factor for asthma but the mechanistic basis for this association is not well understood. In the current study, the impact of obesity on lung inflammatory responses after allergen exposure was investigated. C57BL/6 mice maintained on a high-fat diet (HFD) or a normal diet (ND) after weaning were sensitized and challenged with cockroach allergen (CRA). Airway inflammation was assessed based on inflammatory cell recruitment, measurement of lung Th1-Th2 cytokines, chemokines, eicosanoids, and other proinflammatory mediators as well as airway hyperresponsiveness (AHR). CRA-challenged mice fed a HFD exhibited significantly decreased allergen-induced airway eosinophilia along with reduced lung IL-5, IL-13, LTC4, CCL11, and CCL2 levels as well as reduced mucus secretion and smooth muscle mass compared to ND fed mice. However, allergen-challenged HFD fed mice demonstrated significantly increased PAI-1 and reduced PGE2 levels in the lung relative to corresponding ND fed mice. Interestingly, saline-exposed HFD fed mice demonstrated elevated baseline levels of TGF-ß1, arginase-1, hypoxia-inducible factor-1α, and lung collagen expression associated with decreased lung function compared to corresponding ND fed mice. These studies indicate that a HFD inhibits airway eosinophilia while altering levels of PAI-1 and PGE2 in response to CRA in mice. Further, a HFD can lead to the development of lung fibrosis even in the absence of allergen exposure which could be due to innate elevated levels of specific profibrotic factors, potentially affecting lung function during asthma.

Validating a claims-based method for assessing severe rectal and urinary adverse effects of radiotherapy.

OBJECTIVE: To validate a claims-based algorithm for detecting severe rectal and urinary adverse effects (AEs) of radiotherapy (RT) to inform the design and interpretation of outcomes studies, using administrative datasets to detect such RT AEs. METHODS: An institutional billing analysis was performed to identify patients managed with RT for prostate or cervical cancer at the University of Minnesota, between 2000 and 2006. A priori, we identified Current Procedural Terminology procedural codes consistent with treatment for severe RT AEs. A retrospective chart review and a billing (ie "claims") analysis were performed to detect the procedures used to treat RT AEs. The accuracy of the claims-based algorithm was compared with chart review (the reference standard). RESULTS: On chart review, 31 patients (7.6%) with severe rectal and urinary RT AEs were detected among 406 patients with nonmetastatic cancer at diagnosis. The most common AE was ureteral stenosis (25% of all AEs). The sensitivity and specificity of the claims-based analysis were 75% and 100% respectively for urethral stricture, 100% and 99% respectively for ureteral stricture, 60% and 100% respectively for radiation cystitis, 88% and 100% respectively for rectal or urinary fistula, and 88% and 100% respectively for radiation proctitis. CONCLUSION: We demonstrated an excellent specificity and yet fairly good sensitivity of our claims-based algorithm for detecting treatment of urethral stricture, rectal or urinary fistulas, radiation proctitis, and ureteral stricture. These data might inform the design and interpretation of studies using claims-based methods for the detection of severe urinary AEs of pelvic RT.