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INTRODUCTION Equitable access to HIV pre- and postexposure prophylaxis for women is essential to ending the HIV epidemic. Providers' lack of knowledge and comfort in discussing and prescribing pre-exposure prophylaxis to women persist as barriers. METHODS From May to November 2019, the New York City Health Department conducted its first public health detailing campaigns among women's healthcare providers to promote pre- and postexposure prophylaxis and the associated best practices. Over 2 campaigns (10 weeks each), trained Health Department representatives visited providers for 1-on-1 visits at select practices to promote key messages. Representatives distributed an Action Kit that addressed knowledge gaps and practice needs on providing pre-exposure prophylaxis and postexposure prophylaxis to cisgender and transgender women. Providers completed an assessment at the beginning of initial and follow-up visits, used to compare responses across visits. Statistically significant changes were evaluated by generalized linear models of bivariate outcomes, adjusted for nonindependence of providers at the same practice. RESULTS Representatives visited 1,348 providers specializing in primary care (47%), women's health (30%), adolescent health (7%), infectious disease (4%), and other (12%) at 860 sites; 1,097 providers received initial and follow-up visits. Provider report of ever prescribing pre-exposure prophylaxis increased by 12% (n=119 providers); increases were reported in measures of taking sexual history, asking about partners' HIV status, providing postexposure prophylaxis, recognizing pre-exposure prophylaxis's effectiveness, and discussing and referring for pre-exposure prophylaxis. CONCLUSIONS After public health detailing, women's healthcare providers report increased adoption of recommended practices that promote pre- and postexposure prophylaxis uptake and sexual wellness among women. Detailing may be adaptable to other regions and contexts to reach providers.

We examined recent pre-exposure prophylaxis (PrEP) use (past 6 months) and its correlates among a large sample of men who have sex with men and transgender and gender non-conforming persons participating in a home HIV self-testing program conducted by the New York City Health Department between 11/2016 and 1/2017. Correlates examined included demographic characteristics and HIV-related behaviors in the past 6 months. Associations with recent PrEP use were assessed using log-binomial regression. 400 (22.5%) of 1776 participants reported recent PrEP use. In adjusted models, recent PrEP use was associated with Manhattan residence [adjusted prevalence ratio (aPR) 1.26; 95% confidence interval (CI) (1.04, 1.53)], higher income [aPR 1.29; 95% CI (1.03, 1.62)], and having insurance [aPR 1.89; 95% CI (1.33, 2.69)]. All HIV-related behaviors, except for injection drug use, were individually associated with PrEP use. More research is needed to better understand barriers to PrEP use among patients who are low income and/or uninsured as this may help improve current public health efforts to increase PrEP uptake among disproportionately impacted populations.

BACKGROUND: Preexposure prophylaxis (PrEP) for HIV prevention requires engagement throughout the PrEP care continuum. Using data from a PrEP navigation program, we examine reasons for PrEP discontinuation. SETTING: Participants were recruited from New York City Health Department Sexual Health Clinics with PrEP navigation programs. METHODS: Participants completed a survey and up to three interviews about PrEP navigation and use. This analysis includes 94 PrEP initiators that were PrEP-naïve prior to their clinic visit, started PrEP during the study, and completed at least two interviews. Interview transcripts were reviewed to assess reasons for PrEP discontinuation. RESULTS: Approximately half of PrEP initiators discontinued PrEP during the study period (n=44; 47%). Most participants (71%) noted systemic issues (insurance or financial problems, clinic or pharmacy logistics, and scheduling barriers) as reasons for discontinuation. One-third cited medication concerns (side effects, potential long-term side effects, and medication beliefs; 32%) and behavioral factors (low relevance of PrEP due to sexual behavior change; 34%) as contributing reasons. Over half (53.5%) highlighted systemic issues alone, while an additional 19% attributed discontinuation to systemic issues in combination with other factors. Of those who discontinued, approximately one-third (30%) restarted PrEP during the follow-up period, citing resolution of systemic issues or behavior change that increased PrEP relevance. CONCLUSION: PrEP continuation is dependent on interacting factors and often presents complex hurdles for patients to navigate. To promote sustained engagement in PrEP care, financial, clinic, and pharmacy barriers must be addressed and counseling and navigation should acknowledge factors beyond sexual risk that influence PrEP use.

Objectives The aim of this study was to find out the correlation and evaluate the accuracy of labial minor salivary gland biopsy as a diagnostic tool in the multidisciplinary management of patients with Sjogren syndrome. Materials and methods Patients, referred to our outpatient office between January 2014 and December 2018 from a rheumatologist for biopsy examination, as part of the complex diagnostic plan for suspected Sjogren syndrome, were included in the current study. Each specimen was examined histomorphometrically by the pathologist to calculate the focus score describing the degree of salivary gland inflammatory infiltration. Results Fifty patients met the inclusion criteria. From the total number of patients, 39 presented with an established Sjogren syndrome by fulfilling the revised American-European criteria. From those, 27 had a positive lip biopsy. The remaining 12 patients from the total group, who were diagnosed with Sjogren syndrome based on the same criteria, had a negative lip biopsy. Conclusion The labial minor salivary gland biopsy is a valuable diagnostic tool to establish the diagnosis of Sjogren syndrome. However, a positive biopsy result must always be correlated with all the other diagnostic criteria to prove the exact diagnosis (Tab. 1, Fig. 4, Ref. 49). Text in PDF www.elis.sk Keywords: Sjogren syndrome, keratoconjunctivitis sicca, xerostomia, labial minor salivary glands, biopsy, focal lymphocytic infiltration, focus score.

PurposeAwareness raising campaigns have been used to promote HIV prevention messages, including the expansion of HIV testing, but initiating such campaigns de novo can be costly. Both the Bronx, New York and Washington, DC have significant local HIV epidemics and a history of efforts to scale-up HIV testing. To build on prior HIV testing campaigns and create new messages based on consultation with diverse stakeholders, a partnership with a community-based clinical trial to enhance HIV testing and treatment was established. The purpose of this paper is to describe the history of HIV testing campaigns in the two jurisdictions, the awareness raising conducted in collaboration with the HIV Prevention Trials Network (HPTN) study (HPTN 065) and provide evidence of its effect in these two communities.Design/methodology/approachThe foundation of prior campaigns allowed for expansion of social mobilization efforts to specific priority populations (gay men and other men who have sex with men), the most severely affected groups in both communities, and to expand the efforts to include clinical settings. New compelling and acceptable messages were shaped through engagement with community members and based on input from focus groups with target populations in each city.FindingsBy engaging the target population in the development of new messaging, HPTN 065 study successfully built on campaigns that were already underway in both jurisdictions and was able to use those messages and platforms to further normalize HIV testing.Practical implicationsModifying and adapting existing messages saved time and resources, which can be important factors to consider in settings with limited resources or high media purchasing costs.Originality/valueEfforts of this kind may ultimately help to decrease HIV transmission in large urban settings.

The main topic of this case study is local community response to environmental contamination resulting from corruption and waste mismanagement. The field research was carried out in part of a massive Italian district colloquially referred to as the "land of fires” where illegal wastes dumped by the mafia routinely burned. A document analysis, participant observation and semi-structured interviews were conducted. Abandoned by those tasked with protecting public and environmental health, one might expect widespread concern, activism and protest. The case study supports the theory in terms of citizen mobilization while clarifying conditions that discourage public protest and action. The waste companies and the governmental institutions intended to regulate them were perceived as jointly complicit. Those who did not protest appeared to be caught in a classic double bind in which any response they made was wrong. Fear that the contamination and fires were harming their health demanded action. Yet, citizens dreaded that such efforts would bring mob and institutions' reprisal and did not have practical effective outcomes. This dilemma is fully explored, and the results are discussed within an eco-historical perspective. The case study is also updated to reflect more recent conditions that inspired widespread protest in the same affected region.

This study includes three patients with various peripheral neuropathies after contracting coronavirus disease 2019 (COVID-19) infection, treated both conservatively and surgically. While cases of neurological complications have been described, neuropathy associated with COVID-19 is under-reported in orthopaedic literature. These patients presented with ulnar neuropathy, critical care polyneuropathy (CCP) with anterior interosseous nerve (AIN) neuropathy, and lateral femoral cutaneous nerve (LFCN) neuropathy. COVID-19 infection may be associated with peripheral neuropathy in addition to various neurological sequelae. Orthopaedic surgeons should screen patients for recent infections and evaluate the severity of the illness to assess for risk of neurological sequelae of COVID-19 infection.

Thirty-eight tracheostomies were performed on patients with respiratory failure secondary to SARS-CoV-2 infection over the month of April at North Shore University Hospital and Lenox Hill Hospital (members of Northwell Health System in Long Island and New York City). Follow-up by May 14 revealed that 21 (55.2%) had been weaned from ventilators and 7 (18.4%) underwent decannulation. Two patients (5.3%) expired in the weeks following tracheostomy. Between the 2 institutions, 10 attending surgeons performed all of the tracheostomies using appropriate personal protective equipment, and none demonstrated seroconversion within 1 to 2 weeks of this article.

Although HIV pre-exposure prophylaxis can decrease new cases of HIV by up to 99%, many patients who could benefit from pre-exposure prophylaxis never receive prescriptions for it. Because pre-exposure prophylaxis is indicated for patients who do not have an infectious disease, increasing pre-exposure prophylaxis prescribing by primary care and generalist clinicians represents a key element of the Ending the HIV Epidemic in the U.S. initiative. This review provides an overview of academic detailing and how it is currently being used to increase pre-exposure prophylaxis prescribing. Academic detailing is outreach education that engages with clinicians in 1-to-1 or small group interactions focused on identifying and addressing an individual clinician's needs to increase their use of evidence-based practices. Academic detailing has been proven in multiple previous research studies, and the principles required for successful implementation include interactivity, clinical relevance of content, and focus on defined behavior change objectives. Clinician barriers to pre-exposure prophylaxis prescribing may occur in the domains of knowledge, attitudes, or behavior, and academic detailing has the potential to address all of these areas. State and local health departments have developed academic detailing programs focused on pre-exposure prophylaxis prescribing and other elements of HIV prevention-sometimes describing the approach as public health detailing. Few studies of academic detailing for pre-exposure prophylaxis have been published to date; rigorous evaluation of HIV-specific adaptations and innovations of the approach would represent an important contribution. In the setting of the COVID-19 pandemic, interest in virtual delivery of academic detailing has grown, which could inform efforts to implement academic detailing in rural communities and other underserved areas. Increasing this capacity could make an important contribution to Ending the HIV Epidemic in the U.S. and other HIV prevention efforts.

Background HIV self-tests increase HIV status awareness by providing convenience and privacy, although cost and access may limit use. Since 2015, the New York City (NYC) Health Department has conducted 5 waves of an online Home Test Giveaway. Methods We recruited adult cisgender men who have sex with men (MSM) and transgender and gender-nonconforming (TGNC) individuals who had sex with men, who were living in NYC, not previously HIV diagnosed, and using paid digital advertisements (4-8 weeks per wave). Eligible respondents were e-mailed a code to redeem on the manufacturer's website for a free HIV self-test and an online follow-up survey ~2 months later. For key process and outcome measures, we present means across 5 waves. Results Across the 5 waves of Home Test Giveaway, there were 28,921 responses to the eligibility questionnaire: 17,383 were eligible, 12,182 redeemed a code for a free HIV self-test, and 7935 responded to the follow-up survey (46% of eligible responses). Among eligible responses, approximately half were Latino/a (mean, 32%) or non-Latino/a, black (mean, 17%). Mean report of never testing before was 16%. Among 5903 follow-up survey responses who reported test use, 32 reported reactive results with no known previous diagnosis (0.54%), of whom 78% reported receiving confirmatory testing. Report of likelihood of recommending the Home Test Giveaway to friends was high (mean, 96%). Conclusions We recruited diverse NYC MSM and TGNC and distributed a large number of HIV self-tests to them. Among respondents who reported newly reactive tests, the majority reported confirmatory testing. This seems to be one acceptable way to reach MSM and TGNC for HIV testing, including those who have never tested before.

Health care providers in New York City can prescribe treatment for Chlamydia trachomatis (Ct) for a patient's partner without the partner having a medical evaluation ("prescription-expedited partner therapy" [EPT]), and use of prescription-EPT is common. However, there is little known about pharmacists' knowledge and practices surrounding EPT.Two cross-sectional surveys, in 2012 and 2014, were conducted with representative samples of supervising pharmacists in NYC neighborhoods with high rates of Ct infection.In both survey years, the majority of pharmacists who agreed to participate returned a survey (2012: 81% [83/103], 2014: 61% [106/173]), and pharmacist and pharmacy characteristics were similar across the 2 surveys. Pharmacists' EPT-related knowledge and practice was generally low, with little change between 2012 and 2014. In both years, fewer than half of pharmacists knew EPT was legal (2012, 46%; 2014, 42%). There were even decreases in specific content knowledge; in 2014, significantly fewer of the pharmacists who knew EPT was legal, knew that the initials "EPT" must be written in the body of the prescription (2012: 58%; 2014: 36%, P0.05). Most pharmacists in both survey years reported they had never received an EPT prescription, and those who had reported only infrequent receipt.NYC pharmacists had low levels of knowledge and familiarity with EPT law and reported infrequent receipt of EPT prescriptions. Pharmacists and providers should be further educated about EPT laws and regulations so that prescription-EPT use can be accurately monitored, and to assure the success of this partner treatment strategy.

The purpose of this study was to assess outcomes in patients who have undergone celiac plexus neurolysis (CPN) as treatment for refractory abdominal visceral pain at a tertiary care medical center. This study involved retrospective analysis of all patients who had undergone computed tomography (CT)-guided CPN over a 7-year period, as identified in the medical record. Cases were categorized into 1 of 3 groups—group 1: patients getting at least moderate improvement in pain but with improvements subsiding within 2 days; group 2: patients with some sustained pain relief but still requiring heavy doses of narcotics; group 3: patients with major or complete sustained reduction in pain where the narcotic dose was able to be reduced. One hundred thirty-eight cases were identified, 51 of which had no or insufficient follow-up, leaving 87 cases for analysis. Of the 87 cases, 31 (36%) were categorized as group 1, 21 (24%) as group 2, and 35 (40%) as group 3. There were no statistical differences in outcomes based on patient age, gender, time since diagnosis, or type of cancer. Documented postoperative complications were diarrhea (11 cases) and 1 case each of obtundation, hypotension, and presyncopal event. We conclude that patients undergoing CT-guided CPN for abdominal visceral pain achieve moderate or major short-term pain relief in a majority of cases. The procedure is safe with minimal complications.

The scale-up of preexposure prophylaxis (PrEP) represents a paradigm shift in HIV prevention that poses unique challenges for public health programs. Monitoring of PrEP implementation at the population level is a national priority, with particular significance in New York City (NYC) given the substantial HIV burden and the prominence of PrEP in state and local Ending the Epidemic program plans. We highlight the importance of local monitoring and evaluation of PrEP implementation outcomes and describe the experience at the NYC Health Department, which includes engaging communities, triangulating a variety of data sources regarding PrEP implementation, and leveraging those data to help guide programming. In NYC, we used data from national surveillance systems and incorporated PrEP-related indicators into existing local data collection systems to help illustrate gaps in PrEP awareness and use. Ultimately, ensuring that PrEP achieves the desired impact at the population level depends on identifying disparities through appropriate and accurate measurement, and addressing them through evidence-based programs.

Recent biomedical advances inspire hope that an end to the epidemic of HIV is in sight. Adopting new approaches and paradigms for treatment and prevention in terms of both messaging and programming is a priority to accelerate progress. Defining the key sequential steps that comprise engagement in HIV care has provided a useful framework for clinical programs and motivated quality improvement initiatives. Recently, the same approach has been applied to use of pre-exposure prophylaxis for HIV prevention. Building on the various prevention and care continua previously proposed, we present a novel schematic that incorporates both people living with HIV and people at risk, making it effectively “status-neutral” in that it proposes the same approach for engagement, regardless of one’s HIV status. This multidirectional continuum begins with an HIV test and offers 2 divergent paths depending on the results; these paths end at a common final state. To illustrate how this continuum can be utilized for program planning as well as for monitoring, we provide an example using data for New York City men who have sex with men, a population with high HIV incidence and prevalence.

Despite the promise of human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), PrEP remains underutilized, often due to clinician factors. Academic or public health detailing is a process by which university and/or government groups employ the marketing practices of pharmaceutical companies to improve clinical practice. We describe the novel application of detailing to increase PrEP prescribing and related care in New York City and New England. Detailing can play a crucial role in PrEP implementation.

Factors associated with prevalent and incident HIV infection were compared among sexually experienced Ugandans aged 15–24. Most factors were similar. However, in women, older age and current marriage were associated with prevalent, but not incident, infection. It is important to recognize the limitations of prevalence analyses for identifying at-risk youth.

Objective To develop a clinical consensus statement on the use of sinus ostial dilation (SOD) of the paranasal sinuses. Methods An expert panel of otolaryngologists was assembled to represent general otolaryngology and relevant subspecialty societies. The target population is adults 18 years or older with chronic or recurrent rhinosinusitis (with or without nasal polyps, with or without prior sinus surgery) for whom SOD is being recommended, defined as endoscopic use of a balloon device to enlarge or open the outflow tracts of the maxillary, frontal, or sphenoid sinuses, as a standalone procedure or with endoscopic surgery. A modified Delphi method was used to distill expert opinion into clinical statements that met a standardized definition of consensus. Results After 3 iterative Delphi method surveys, 13 statements met the standardized definition of consensus while 45 statements did not. The clinical statements were grouped into 3 categories for presentation and discussion: (1) patient criteria, (2) perioperative considerations, and (3) outcomes. Strong consensus was obtained for not performing SOD in patients without sinonasal symptoms or positive findings on computed tomography (CT) in patients with symptoms only of headache or sleep apnea without criteria for sinusitis. In addition, strong consensus was met that CT scan of the sinuses was necessary before performing SOD and that surgeons need to understand and abide by regulations set forth by the US Food and Drug Administration if they choose to reuse/reprocess devices. Conclusion Expert panel consensus may provide helpful information for the otolaryngologist considering the use of SOD for the management of patients with a diagnosis of rhinosinusitis. This panel reached consensus on a number of statements that defined the use of SOD as inappropriate in the management of a variety of symptoms or diseases in the absence of underlying sinusitis. When patients meet the definition of chronic sinusitis as confirmed by CT scan, SOD of the sinuses can be indicated and/or effective in certain scenarios. Additional consensus statements regarding proper setting and safeguards for performing the procedure are described.

Introduction In 2010, the New York State Legislature made it mandatory to offer an HIV test to people aged 13-64 years receiving hospital or primary care services, with limited exceptions. In this study, we used data from New York City practices to evaluate the impact of the law on HIV testing rates in ambulatory care. Methods We collected quarterly testing data from the electronic health records of 218 practices. We calculated overall and stratified crude testing rates. Using univariate and multivariate generalized estimating equation models, we assessed the odds of testing in the year before the law (baseline) versus the first and second year after the law's implementation (year 1 and year 2). Results During baseline, the odds of testing did not increase significantly. During year 1, the odds of testing significantly increased by 50% in the univariate model and 200% after adjusting for confounders. During year 2, the odds of testing increased 10%. This was only significant in the univariate model. The crude quarterly testing rate increased from 2.8% to 5.7% from baseline to year 2. Conclusions Our evaluation showed that after the implementation of the HIV testing law, there was an increase in HIV testing among NYC ambulatory practices. Testing rates remained modest, but considerable improvement was seen in community health centers, in age ranges targeted by the law and in practices that were screening for HIV at baseline. This study suggests that legislation may be effective when used in a comprehensive prevention strategy.

Background. Fracture resulting from household electric shock is uncommon. When it occurs, it is usually the result of a fall; however, electricity itself can cause sufficient tetany to produce a fracture. We present the case of bilateral fractures of the distal radii of a 12-year-old boy which were sustained after accidental shock. The literature regarding fractures after domestic electric shock is also reviewed.Methods. An Ovid-Medline search was conducted. The resultant articles and their bibliographies were surveyed for cases describing fractures resulting from a typical household-level voltage (110–220 V, 50–60 Hertz) and not a fall after the shock. Twenty-one articles describing 22 patients were identified.Results. Twenty-two cases were identified. Thirteen were unilateral injuries; 9 were bilateral. Proximal humerus fractures were most frequent (8 cases), followed by scapula fractures (7 cases), forearm fractures (4 cases), femoral neck fractures (2 cases), and vertebral body fracture (1 case). Eight of the 22 cases were diagnosed days to weeks after the injury.Conclusions. Fracture after electric shock is uncommon. It should be suspected in patients with persistent pain, particularly in the shoulder or forearm area. Distal radius fractures that occur during electrocution are likely due to tetany.

Adolescent risk-taking may have long-term consequences for adult cancer risk. Behaviors such as smoking and sexual activity, commonly initiated during adolescence, may result—decades later—in cancer. Life course epidemiology focuses on unique vulnerabilities at specific development periods and their importance to later development of disease. A life course epidemiological perspective that integrates social and biological risk processes can help frame our understanding how specific adult cancers develop. Moreover, life course perspectives augment traditional public health approaches to prevention by emphasizing the importance of unique windows of opportunity for prevention.

According to libertarian homesteading theory, in order to convert unowned virgin territory into ownership status, one must mix one’s labor with it, thus transforming it through his efforts into land that can be better used by humanity than what was initially there. But, what about acreage whose sole purpose is the contemplation of nature; a nature preserve, that is, untouched by human hands or feet? How can that be taken out of nature and converted into ownership if through this very process, the land is no longer untouched? The present paper attempts to wrestle with this vexing issue

Human papillomavirus (HPV) is a common sexually transmitted infection in men [1], and high-risk HPV (hrHPV) is an etiologic agent for male anogenital cancers [2]. Although these cancers are rare worldwide, hrHPV infection in heterosexual men is also important because it can be transmitted to women. In women, the most common clinical sequelae of hrHPV infections are cervical lesions, which can lead to cervical cancer, the second most common cancer in women worldwide [3]. The prevalence of genital HPV infection is equally high in both genders [1, 4], and the incidence is as high in males as it is in females, or higher [5, 6]. However, HPV seroprevalence is lower in males than in females, in both general [7, 8] and high-risk populations [9–13]. In one of the few studies of HPV seroconversion in women (a cohort study of female university students aged 18–20 years [14]), 94% of women with prevalent genital HPV-16 infection at enrollment seroconverted within 13 months, and 67% of women with incident HPV-16 infection seroconverted within 24 months of incident detection. A similar study of antibody response has not been conducted in men, with most serologic investigations limited by their cross-sectional design. In this longitudinal study, we examined HPV type-specific seroconversion among heterosexual male university students infected in the genital tract with one or more α9 HPV type (HPV-16, -31, -33, -35, -52, -58, or -67)[15].

Background. Viral load may influence the course of human papillomavirus type 16 (HPV-16) infection. Methods. This case-control study was nested within the 2-year Atypical Squamous Cells of Undetermined Significance and Low-Grade Squamous Intraepithelial Lesion Triage Study, in which women were followed semiannually for HPV and cervical intraepithelial neoplasia (CIN). Case patients (n 5 62) were women diagnosed with CIN3 following HPV-16–positive detection at a follow-up visit. HPV-16–positive controls (n 5 152) without CIN2 or CIN3 were matched to cases based on the follow-up visit in which viral load was measured. Real-time polymerase chain reaction was used for HPV-16 DNA quantification. Results. The risk of CIN3 increased with increasing HPV-16 DNA load at the follow-up visit (odds ratio, 1.63; 95% confidence interval, 1.33–1.99 per 1 log10 unit increase); the association was not affected by whether HPV-16 was present at enrollment. When HPV-16 was present at both enrollment and follow-up, viral load remained high among cases (P 5 .77) but decreased substantially among controls (P 5 .004). Among women with HPV-16 found initially during follow-up, viral load in the first HPV-16–positive sample was associated with shortterm persistence; load was higher in those with infection, compared with those without infection, 1 visit after the initial positivity (P 5 .001). Conclusions. Viral load of newly detected infections and changes in viral load predict persistence and progression of HPV-16 infections.

Studies of viral load-associated persistence of human papillomavirus (HPV) infection are rare, with inconsistent results reported.The study subjects were 741 and 289 women who were positive for HPV type 16 (HPV-16) and HPV type 18 (HPV-18), respectively, at the time of enrollment into in the ASCUS-LSIL (Atypical Squamous Cells of Undetermined Significance-Low-Grade Squamous Intraepithelial Lesion) Triage Study and who returned 1 or more times for HPV testing during a biannual 2-year follow-up. The numbers of HPV-16 and HPV-18 copies per nanogram of cellular DNA at baseline were measured by use of real-time polymerase chain reaction.Women with, compared with women without, persistent infection at month 6 of follow-up had a higher viral load at enrollment (P.001, for HPV-16; P=.01, for HPV-18). The association of each 1-log(10) increase in viral load with persistence of HPV-16 or HPV-18 during the first 6 months of the study was statistically significant among women with multiple HPV types at enrollment (for HPV-16: odds ratio [OR], 1.53 [95% confidence interval {CI}, 1.29-1.82]; for HPV-18: OR, 1.35 [95% CI, 1.09-1.68]) but not among women with monotype infections (in tests assessing the interaction between viral load and coinfection, P=.002 for HPV-16 and P=.34 for HPV-18). Among women who continued to have positive results at month 6, 12, or 18, persistence of infection for another 6 months was unassociated with the viral load at baseline.Prevalent infection with a higher viral load of HPV-16 or HPV-18 was associated with short- but not long-term persistence.

Background & Aims: Aside from chronic reflux, the etiology of Barrett's esophagus (BE) remains largely unknown. This case-control study investigated body mass index (BMI), central adiposity, and cigarette smoking and risk of BE. Methods: Washington residents newly diagnosed with specialized intestinal metaplasia on at least 1 of 4 esophageal biopsy specimens taken at community gastroenterology clinics (cases [n = 193]) were compared with matched population controls (n = 211). Case subgroups included those with any visible columnar epithelium (visible BE) and those with at least 2 cm of columnar epithelium (long-segment BE [LSBE]). Interviewers conducted personal interviews and took anthropometric measurements. Results: All measures of central adiposity were strongly related to BE risk, particularly for LSBE. For the high category of waist-to-hip ratio (WHR), the adjusted odds ratios were 2.4 (95% confidence interval [CI]: 1.4–3.9) for all cases, 2.8 (95% CI: 1.5–5.1) for visible BE, and 4.3 (95% CI: 1.9–9.9) for LSBE. In contrast, the associations with BMI were weaker. When BMI and WHR were modeled simultaneously, the associations with BMI were greatly attenuated, whereas those with WHR remained strong. Further adjustment for frequency of heartburn did not change these results. Cigarette smoking moderately increased risk but with no evidence of a dose-dependent response or increasing strength by case group. Conclusions: These observations indicate the importance of identifying the mechanisms underlying obesity's role in BE and esophageal adenocarcinoma, and suggest that weight loss might be a fruitful approach to the prevention of these diseases.

SummaryEvidence for the efficacy of a drug can be obtained through a controlled trial involving groups of comparable individuals studied simultaneously. Variations between individuals may suffice to account for differences observed between groups (sampling error) and such variations must be taken into account when interpreting the results.In addition to statistical errors (false differences : type I error; concealed differences: type II error), systematic errors, or bias, favoring one treatment to the detriment of another may distort the comparison.Before undertaking a trial, a single, clear and explicit question must be formulated.A difference can only be proven (with an acceptable risk of error) by rejecting a working "null" hypothesis of no difference. If the difference is substantial compared to the variability of the responses, the probability that this difference is due to sampling error is low. Such a difference is said to be statistically significant and the null hypothesis may be rejected.In the opposite case, all that can be said is that there is no evidence for any difference (unless with the alternative hypothesis a power calculation has been done or if the sample size chosen a priori was large enough to allow rejection of this hypothesis with a sufficient degree of probability).The results of a trial can only be extrapolated to similar patients receiving the same treatments under similar conditions. A trial can only answer the question it was designed for.Finally, non-reproducible results may be due to bias, statistical errors or differences in the quality of similar trials.

SummaryPatient compliance with therapy should not be overestimated. During a clinical trial, it is good practice to evaluate compliance by discussing it with the patient, counting unconsumed pills, su

SummaryAssignment of patients to treatment groups by randomization is the only way to insure that the assigned treatment cannot be predicted, that the treatment is independent of the patient’s characteristics and that uncontrolled variability factors are distributed at random between the groups. In practice, tables of random numbers are used, or better still tables of random permutations, which balance the number of patients in each group.Stratification enables separate randomization within subsets of patients that share a common prognostic factor. This procedure permits broader recruitment of patients but it is limited by the number of prognostic factors that can be used.Finally, adaptive or sequential procedures for treatment assignment can be used either to balance the distribution of prognostic factors as the trial proceeds, or to assign a progressively increasing number of patients to the treatment which stands out as the most effective.

SummaryPerforming a “controlled” trial of a given treatment modality means comparing it either with a placebo or with a standard reference treatment. It must be kept in mind that the smaller the diffe

SummaryThe sample size determines the probability of detecting a difference between the treatments compared in a controlled trial. A large number of subjects is required in the following circumstances

SummaryAn experiment may be designed in several different ways.Parallel groups represent a simple, though often relatively ineffective procedure with a risk of bias if prognostic factors are overlooke

SummaryThe purpose of blind trials is to reduce observer bias (subjective interpretation of results and heterosuggestion) and patient bias (subjective interpretation of symptoms and autosuggestion) by concealing the identity of the treatment administered either from the patient, the physician (which entails examination of the patient by a “blind” observer), or from both.When the identity of the treatment is concealed from both patient and physician, the trial is termed “double-blind”. The following conditions must be observed when performing a double-blind trial: •the drugs compared should be as indistinguishable as possible;•the code should be accessible in case of an emergency;•strict precautions should be taken to avoid leaks.Sometimes, an “open” (non-blind) study may provide for “blind” interpretation of results by a third person who remains unaware of treatment assignment. It is preferable to conduct an open trial rather than a false double blind trial in which the treatments have been made blatantly obvious by “leaks” or by their characteristic effects.

SummaryThe life table method is used in therapeutic trials where patients are included at different times, followed up for variable periods of time and where the evaluation criterion is the time it ta

SummaryIn addition to the actual pharmacological effect of a drug, its efficacy depends on a number of non-specific factors globally termed the placebo effect. To distinguish the pharmacological effect from the non-specific effect it may be justified to compare a supposedly active drug to a placebo, a “pseudo-drug” identical in appearance but pharmacologically inert.Factors underlying the placebo effect include the patient’s personality (placebo reactor or non-reactor), the convictions and enthusiasm of the medical staff, the conditions of administration and the appearance of the drug.The placebo effect does not appear to present distinctive characteristics which distinguish it from a true pharmacological effect and it may even be associated with adverse effects, known as a nocebo effect.A placebo may be used in comparison with a pharmacologically active preparation or it may form a three-way comparison with two supposedly active preparations to ensure that the criterion for assessment is sufficiently sensitive. Placebos can also be used for a double-blind comparison of two drugs that cannot be made to look alike (double-dummy technique), to compare drug combinations with their individual constituents, and finally during run-in, withdrawal or wash-out periods.Selecting placebo non-reactors for a therapeutic trial is sometimes possible to make the comparison more sensitive.It is extremely important that the placebo match the active preparation as closely as possible.So-called “impure placebos” (i.e. drugs of dubious efficacy or preparations producing the same side-effects as the active drug under study) should be avoided since the results may subsequently prove impossible to interpret.Finally, the ethics of using a placebo should be given due consideration, if possible by an independent committee.