Search

Objectives Pneumoperitoneum with peritonitis, although uncommon, is a serious injury encountered in the pediatric emergency department. Although the patients may often appear ill or toxic, they can have normal vital signs at initial presentation. Patients with such injury can present with a variety of complaints because of the nature of referred pain. As a result, some patients may be more or less straightforward, thus illustrating the importance of obtaining a detailed history and performing a thorough physical examination. Methods We discuss an uncommon case report of pneumoperitoneum with peritonitis in an adolescent patient presenting with vaginal bleeding and abdominal pain hours after vigorous coitus. Results Examination under anesthesia, flexible sigmoidoscopy, and exploratory laparoscopy revealed a vaginal laceration and a 2- to 3-cm perforated area at the left edge of the vaginal laceration that involved the rectovaginal septum entering the peritoneal cavity. Conclusions Pneumoperitoneum resulting from vaginal intercourse in an otherwise healthy adolescent female is a rare cause of peritonitis. Although it has been described in the adult literature, this case illustrates the importance of considering sexual history as a contributory factor in pediatric patients presenting with an acute abdomen.

PURPOSE: Little is known about the provision of oncologic services by Project Access safety net care coordination programs. MATERIALS AND METHODS: Information on safety net care coordination program locations, health services, and patient eligibility was obtained via program Web sites and calls. For programs not offering oncologic care, program directors were interviewed to identify oncologic care barriers. RESULTS: Web sites of 29 safety net care coordination programs in 22 states were identified; 62% (n = 18) offered oncologic services. Programs were in 65% (n = 11) of states that did not expand Medicaid. Of those offering oncologic services, 83% (n = 15) offered free chemotherapy, and 93% (n = 27) of all programs offered oncologic imaging. Program director interviews revealed costs, longitudinal care, and multiple-physician buy-in as barriers limiting oncologic care. CONCLUSION: Third-party care coordination centers provide a novel and potentially unrecognized approach to increasing oncology service access. Further research should identify strategies to overcome the relative lack of oncologic care offerings.

Portrayals of productive outcomes of learning often contrast sharply with actual outcomes of learning. Confronted with problems cloaked in the garb of the real world, the students evidently lack the resources to frame the problems with reference to principled knowledge structures, and thus to solve them on their own. This chapter describes prospects and problems associated with the development of autonomous learning proficiency. It discusses some of the educational policies and practices that stand in the way of improving autonomous learning proficiency. The chapter presents a projection of the characteristics of courses that act to promote or impede students’ engagement in autonomous learning and the development of autonomous learning proficiency. The psychometric approach has largely relied on the administration of questionnaires designed to assess students’ styles of or approaches to learning.

Primary myelofibrosis (PMF) is associated with morbidity and mortality. Ruxolitinib gained US FDA approval for treatment of intermediate/high-risk PMF in November 2011. We evaluated differences in survival and second primary malignancy (SPM) incidence among US PMF patients in the years before and after ruxolitinib approval.We conducted a retrospective study utilizing the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER)-18 database for PMF patients. We divided patients into five-year cohorts pre- (2007-2011) and post-ruxolitinib (2012-2016) approval and compared relative survival rates (RSRs) to the standard population and standardized incidence rates (SIRs) of SPMs between cohorts.We included 2020 patients diagnosed with PMF from 2007-2016 in this study. There was no difference in the four-year RSRs between cohorts (54 % vs. 57 %, p = 0.776). More patients developed SPMs in the post-ruxolitinib cohort (8% vs. 6%, p = 0.041). The majority of SPMs were hematologic with higher incidence of AML transformation in the post-ruxolitinib cohort (SIR 125.29 vs. 70.55).PMF prognosis remains poor in the years following ruxolitinib's approval. SPM incidence including AML transformation is higher in the years after approval. Further studies are needed to determine the true impact of ruxolitnib on population outcomes.

Myelodysplastic syndromes (MDS), a spectrum of heterogeneous hematopoietic stem cell diseases, vary in clinical severity, response to therapy, and propensity toward progression to acute myeloid leukemia. These are acquired clonal disorders resulting from somatic mutations within the hematopoietic stem or progenitor cell population. Understanding the natural history and the risk of developing leukemia and other adverse outcomes is dependent on access to well-annotated biospecimens linked to robust clinical and molecular data. To facilitate the acquisition and distribution of MDS biospecimens to the wider scientific community and support scientific discovery in this disease, the National MDS Natural History study was initiated by the National Heart, Lung, and Blood Institute (NHLBI) and is being conducted in collaboration with community hospitals and academic medical centers supported by the National Cancer Institute (NCI). The study will recruit up to 2000 MDS patients or overlapping myeloproliferative neoplasms (MDS/MPN) and up to 500 cases of idiopathic cytopenia of undetermined significance (ICUS). The National MDS Natural History Study (NCT02775383) will offer the world's largest disease-focused tissue biobank linked to longitudinal clinical and molecular data in MDS. Here, we report on the study design features and describe the vanguard phase of 200 cases. The study assembles a comprehensive clinical database, quality of life results, laboratory data, histopathology slides and images, genetic information, hematopoietic and germline tissues representing high-quality biospecimens and data from diverse centers across the United States. These resources will be available to the scientific community for investigator-initiated research.

Background: Primary myelofibrosis (PMF) has the worst prognosis of the classical BCR-ABL1 negative myeloproliferative neoplasms, with a median overall survival of six years. Factors affecting survival include age, symptom burden, cytopenias, mutation profile, and development of second malignancies including transformation to acute myeloid leukemia (AML). Ruxolitinib, a selective JAK1 and JAK2 inhibitor, was granted approval by the United States (US) Food and Drug Administration for treatment of intermediate and high-risk PMF in November 2011 based on reduction in spleen volume and demonstration of symptom improvement. The impact of ruxolitinib on PMF survival is unknown. In this study, we aimed to evaluate whether there has been a change in survival and patterns of second primary malignancies (SPMs) including AML transformation among PMF population in US after ruxolitinib approval. Methods: Using the National Cancer Institute's Surveillance, Epidemiology, and End Results (SEER)-18 survival and Multiple Primary Standardized Incidence Ratio (MP-SIR) registries, we conducted a retrospective study with patients diagnosed with PMF between the years of 2007 and 2016. We divided these patients into two five-year cohorts, pre-ruxolitinib approval (2007-2011) and post-ruxolitinib approval (2012-2016), and compared relative survival rates (RSRs) and standardized incidence ratios (SIRs) of SPMs between the cohorts. SIRs were calculated as the ratio of observed to expected malignancy cases over the specified time periods. Median follow-up duration was five years for each cohort. RSRs and SIRs were compared between cohorts using two-proportion Z-tests. Results: We included 2164 patients diagnosed with PMF between 2007 and 2016 with data available in the SEER-18 survival and MP-SIR registries. Of these, 1051 (49%) patients were included in the pre-ruxolitinib cohort and 1113 (51%) patients were included in the post-ruxolitinib cohort. There was no significant difference in the four-year RSRs between the pre-ruxolitinib and post-ruxolitinib cohorts (55% vs. 56%, p = 0.719). A higher proportion of SPMs occurred in the post-ruxolitinib cohort when compared with the pre-ruxolitinib cohort (60% vs. 40%, p < 0.001). Hematologic malignancies comprised a majority of all SPMs (AML 39% and non-Hodgkin lymphoma 16%). A higher incidence of AML transformation occurred in the post-ruxolitinib cohort when compared with the pre-ruxolitinib cohort (SIR 121.48 vs. 72.22, p = 0.037). Non-hematologic malignancies were also more common in the post-ruxolitinib cohort when compared with the pre-ruxolitinib cohort (SIR 1.09 vs. 0.94, p < 0.001). The most common non-hematologic malignancies were cancers of the respiratory tract, urinary tract, and prostate gland, though their SIRs were not significant in either cohort. Conclusions: Our study results suggest that despite improvements in prognostication and the approval of ruxolitinib, the prognosis of PMF remains poor in the US. These results may be due to low uptake of ruxolitinib in practice or a lack of benefit from the drug itself. Additionally, for reasons that are unclear, SPM incidence has increased in the five years following the approval of this drug. Further studies should be conducted to determine the cause of these findings. Figure Disclosures Shah: Dren Bio: Consultancy. Vachhani:astellas: Speakers Bureau; agios, blueprint medicines, jazz pharmaceuticals, daiichi sankyo: Membership on an entity's Board of Directors or advisory committees; incyte: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; abbvie: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau.

Introduction: Polycythemia Vera (PV), Essential Thrombocythemia (ET), and Primary Myelofibrosis (PMF) are BCR/ABL1-negative myeloproliferative neoplasms (MPN) that are associated with morbidity and increased mortality. Limited data regarding population-based outcomes for these MPNs have been reported. Our aim was to use the Surveillance, Epidemiology, and End Results (SEER) registry to investigate population based outcomes for PV, ET, and PMF. Methods: The SEER 18 registries were used to identify patients with ICD-O-3 diagnosis codes for PV (9950/3), ET (9962/3), and PMF (9961/3) from 2001-2015. For ET and PMF, histologic diagnosis was required for inclusion. Incidence was age-adjusted to the U.S. 2000 standard population. Causes of death were obtained and MPN-related death was defined as death from any myeloid disorder (ET, PV, PMF, acute myeloid leukemia [AML], acute monocytic leukemia, other myeloid/monocytic leukemia, and aleukemic, subleukemic and NOS). Relative survival (RS) was defined as the ratio of the proportion of observed survivors in a cohort of PV, ET, PMF patients to the proportion of expected survivors in a comparable set of individuals that did not respectively have PV, ET, or PMF, adjusting for the general survival of the US population for race, sex, age, and time when the diagnosis was established. Time to leukemic transformation was calculated using the left-truncated life tables session with a 3-month latency period used to prevent misattribution. Overall survival (OS) was calculated between the date of diagnosis and the date of death, date last known to be alive, or date of the study cut-off (31 December 2018). Variables significant in univariate analysis were included in a multivariate analysis. The Kaplan-Meier method was used to calculate overall survival (OS), and Cox regression model was used to identify predictors of survival. Statistical analyses were performed using JMP version 14.0. Results: 10,988 patients with PV, 9,146 with ET, and 4,022 with PMF were identified in SEER. The median age of diagnosis (interquartile range [IQR]) was 65 years (IQR 54-76), 67 years (IQR 54-77), and 69 years (IQR 60-78) for PV, ET, and PMF respectively. Overall incidence rates (cases/100,000) were 0.86 for PV, 0.72 for ET, and 0.30 for PMF. With a median follow up (in years, 95% confidence interval [CI]) of 7.6 (7.4-7.8), 7.9 (7.8-8.2), and 7.25 (7.0-7.5), the median OS was 11.4 (11.2-11.7), 11.75 (11.3-12.0), and 3.5 (3.3-3.7), for PV, ET, and PMF respectively. RS was better than expected survival for PV and ET, while less than expected survival for PMF (Figure 1). 3853 of PV patients died (35.1%) by the end of the study period, with 4.1% and 34.1% of deaths from PV-related and cardiovascular disease respectively (Table 1). 3142 of ET patients died (34.4%), with 7.2% and 32.2% of deaths from ET-related and cardiovascular disease respectively. 2578 patients with MF died (64.1%), with 13.2%, and 51.9% of deaths from PMF-related and other malignancies respectively. 106 patients (1.0%) with PV, 135 patients (1.5%) with ET, and 127 patients (3.2%) with PMF transformed to AML. Median time to transformation was 4.8, 6.3, and 2.3 years for PV, ET, and PMF respectively. Factors indicating inferior OS on multivariate analysis (Table 2) included age ≥ 65, female sex, and year of diagnosis for PV, age ≥ 65, male sex, and year of diagnosis for ET, and age ≥ 65, and male sex for PMF. Conclusion: Incidence rates for PV, ET, and PMF were similar to previous reports. RS was better than expected survival for PV and ET, while less than expected survival for PMF. The majority of deaths in ET and PV occurred from cardiovascular disease; a finding likely related to these MPNs. Patients with PMF were more likely to die from their disease or a subsequent malignancy. Transformation to AML occurred less frequently than prior large case series, noting a limitation in the current study. Patients with PMF were more likely to transform to AML with a shorter time interval. Older age was associated with worse OS in all patients. Male sex was predictive of worse survival for ET and PMF, while female sex was associated with worse survival in PV. Over the years, survival has improved for PV and remained essentially unchanged for ET and PMF. Figure Disclosures Shah: Dren Bio: Consultancy.

The objective of this study is to evaluate the impact of certified child life specialists (CCLSs) on the emotional responses of children undergoing laceration repair in the emergency department (ED).Patients 4 to 12 years of age who required laceration repair by suturing were prospectively enrolled at an urban tertiary pediatric ED. Certified child life specialists are not available at all times in our institution, allowing for a priori categorization of subjects into 2 comparison groups, those with and those without CCLS involvement. Subjects requiring anxiolysis, pharmacologic sedation, narcotics, or physical restraint were excluded. The Children's Emotional Manifestation Scale, a previously validated Likert-like tool, was used to quantify the patients' distress, with a higher score reflecting a more emotional child. Just before placement of the first suture, subjects were scored by trained independent observers. Baseline data included age, sex, race, type of local anesthetic, length and location of laceration, and analgesics administered. The primary endpoint of emotional score was compared with a 2-tailed Mann-Whitney U test, with a P0.05 considered statistically significant.Two hundred one patients constituted the final study cohort, with 103 (51%) having CCLS involvement. Study groups did not differ in regards to any baseline demographic or clinical characteristics. The median emotional score for patients with child life services was 7 (interquartile range, 6-9) versus 9 (interquartile range, 7.5-12) for those without (P0.0005).Certified child life specialist involvement is associated with less emotional distress for children undergoing laceration repair in the ED.

Rational replacement of the alkyne linker of mGluR5 antagonist MPEP gave 7-arylquinolines. SAR optimization gave an orally active compound with high affinity for the MPEP binding site.

Arthroscopic techniques for the hip joint have evolved into endoscopic methods for extra-articular disorders. These endoscopic strategies provide a less invasive alternative to open procedures for traditionally recognized forms of pathology. Endoscopy has defined new disorders amenable to surgical correction and has redefined some of these existing disorders. The peritrochanteric and deep gluteal regions represent 2 of the most currently active areas of exploration. Peritrochanteric problems include trochanteric bursitis, full-thickness and partial-thickness tears of the abductors including the gluteus medius and minimus, and external coxa saltans (snapping iliotibial band). Deep gluteal disorders include piriformis syndrome, and other variations of deep gluteal syndrome, and ischiofemoral impingement. Each of these evolving areas is highlighted in this chapter.

A structured survey of transit agency staff and interviews with agency executives and other local leaders were conducted in areas that have undertaken a major transit investment project in the past 5 years. The purpose was to identify methods and procedures used to evaluate and select projects and, in particular, to document how land use considerations are being incorporated into project decisions. Staff members responsible for 41 projects were contacted, and 28 completed the survey, discussing projects in 23 regions of the United States. Supplementary interviews were conducted for 10 of the regions. The study found that most agencies use federal guidance and regulations on the evaluation of transit investment as a starting point, but give equal weight in project design and selection to state and local policy objectives such as social equity, economic development, and fair-share distribution of projects among local communities. A number of transit agencies give priority to projects in jurisdictions with transit-supportive land use patterns or plans. The availability of public or private funding contributions is increasingly important in prioritizing projects. Increasingly, transit agencies are hiring staff to work with local governments on land use planning and on funding partnerships and are working with them to develop a shared understanding of the area’s transit needs and related development objectives. Staff and political leaders deem these efforts at least as important as technical evaluations of cost-effectiveness.

Despite over 50 years of research into the states of consciousness induced by various meditation practices, no clear neurophysiological signatures of these states have been found. Much of this failure can be attributed to the narrow range of variables examined in most meditation studies, with the focus being restricted to a search for correlations between neurophysiological measures and particular practices, without documenting the content and context of these practices. We contend that more meaningful results can be obtained by expanding the methodological paradigm to include multiple domains including: the cultural setting (‘the place’), the life situation of the meditator (‘the person’), details of the particular meditation practice (‘the practice’), and the state of consciousness of the meditator (‘the phenomenology’). Inclusion of variables from all these domains will improve the ability to predict the psychophysiological variables (‘the psychophysiology’) associated with specific meditation states and thus explore the mysteries of human consciousness.

Meditation proficiency is related to trait-like (learned) effects on brain function, developed over time. Previous studies show increases in EEG power in lower frequency bands (theta, alpha) in experienced meditators in both meditation states and baseline conditions. Higher gamma band power has been found in advanced Buddhist meditators, yet it is not known if this occurs in Yoga meditation practices. This study used eLORETA to compare differences in cortical source activity underlying scalp EEG from intermediate (mean experience 4 years) and advanced (mean experience 30 years) Australian meditators from the Satyananda Yoga tradition during a body-steadiness meditation, mantra meditation, and non-meditation mental calculation condition. Intermediate Yoga meditators showed greater source activity in low frequencies (particularly theta and alpha1) during mental calculation, body-steadiness and mantra meditation. A similar spatial pattern of significant differences was found in all conditions but the number of significant voxels was double during body-steadiness and mantra meditation than in the non-meditation (calculation) condition. These differences were greatest in right (R) superior frontal and R precentral gyri and extended back to include the R parietal and occipital lobes. Advanced Yoga meditators showed greater activity in high frequencies (beta and especially gamma) in all conditions but greatly expanded during meditation practice. Across all conditions (meditation and non-meditation) differences were greatest in the same regions: R insula, R inferior frontal gyrus and R anterior temporal lobe. Distinct R core networks were identified in alpha1 (8-10 Hz) and gamma (25-42 Hz) bands, respectively. The voxels recruited to these networks greatly expanded during meditation practice to include homologous regions of the left hemisphere. Functional interpretation parallels traditionally described stages of development in Yoga proficiency.

Persons with behavioral disorders incur higher healthcare costs. Although they utilize behavioral health (BH) services others do not, they also have higher utilization of medical services: To determine the degree to which higher costs for persons with BH disorders are attributable to utilization of BH services, multiple chronic medical conditions (CMCs) or other issues specific to populations with BH disorders.Data base consisted of claims for 63,141 Medicaid beneficiaries, 49% of whom had one of 5 categories of BH disorder. Generalized linear models were used to identify relative impact of demographics, BH status, multiple CMCs and primary care access on total, behavioral, nonbehavioral, and medical/surgical costs.Number of CMCs was associated with significant increases in all cost categories, including behavioral costs. Presence of any BH disorder significantly influenced these same costs, including those not associated with BH care. Effect size in each cost category varied by BH group.BH status has a large impact on all healthcare costs, including costs of medical and other non-BH services. The number of CMCs affects BH costs independent of BH disorder. Results suggest that costs might be reduced through better integration of behavioral and medical health services.

Background —These studies were initiated to confirm that high-level thrombomodulin overexpression is sufficient to limit neointima formation after mechanical overdilation injury. Methods and Results —An adenoviral construct expressing thrombomodulin (Adv/RSV-THM) was created and functionally characterized in vitro and in vivo. The impact of local overexpression of thrombomodulin on neointima formation 28 days after mechanical overdilation injury was evaluated. New Zealand White rabbit common femoral arteries were treated with buffer, viral control, or Adv/RSV-THM and subjected to mechanical overdilation injury. The treated vessels (n=4 per treatment) were harvested after 28 days and evaluated to determine intima-to-media (I/M) ratios. Additional experiments were performed to determine early (7-day) changes in extracellular elastin and collagen content; local macrophage, T-cell, and neutrophil infiltration; and local thrombus formation as potential contributors to the observed impact on 28-day neointima formation. The construct significantly decreased neointima formation after mechanical dilation injury in this model. By histological analysis, buffer controls exhibited mean I/M ratios of 0.76±0.06%, whereas viral controls reached 0.77±0.08%; in contrast, Adv/RSV-THM reduced I/M ratios to 0.47±0.06%. Local inflammatory infiltrate decreased in the Adv/RSV-THM group relative to controls, whereas matrix remained relatively preserved. Rates of early thrombus formation also decreased in Adv/RSV-THM animals. Conclusions —This construct thus offers a viable technique for promoting a locally neointima-resistant small-caliber artery via decreased thrombus bulk, normal matrix preservation, and decreased local inflammation without the inflammatory damage that has limited many other adenoviral applications.

A combinatorial mutagenesis strategy was used to create a collection of nearly 500 variants of human interleukin 3 (IL-3), each with four to nine amino acid substitutions clustered within four linear, nonoverlapping regions of the polypeptide. The variants were secreted into the periplasm of Escherichia coli and supernatants were assayed for IL-3 receptor-dependent cell proliferation activity. Sixteen percent of the variants, containing "region-restricted" substitutions, retained substantial proliferative activity through two rounds of screening. A subset of these was combined to yield variants with substitutions distributed through approximately half of the polypeptide. With one exception, "half-substituted" variants exhibited proliferative activity within 3.5-fold of native IL-3. A subset of the "half-substituted" variants was combined to yield "fully substituted" IL-3 variants having 27 or more substitutions. The combination of the substitutions resulted in a set of polypeptides, some of which exhibit increased proliferative activity relative to native IL-3. The elevated hematopoietic potency was confirmed in a methylcellulose colony-forming unit assay using freshly isolated human bone marrow cells. A subset of the multiply substituted proteins exhibited only a modest increase in inflammatory mediator (leukotriene C4) release. The molecules also exhibited 40- to 100-fold greater affinity for the alpha subunit of the IL-3 receptor and demonstrated a 10-fold faster association rate with the alpha-receptor subunit. The multiply substituted IL-3 variants described in this study provide a unique collection of molecules from which candidates for clinical evaluation may be defined and selected.

Purpose To compare and investigate the rate of infection in patients with and without human immunodeficiency virus (HIV) who have implantable venous access devices placed by interventional radiologists. Materials and Methods Three hundred ninety-one patients undergoing radiologically guided placement of peripheral arm ports were grouped according to their HIV serologic status. Findings were prospectively reviewed in 393 peripherally placed arm ports that were implanted in the basilic, cephalic, or brachial vein under fluoroscopic or sonographic guidance over a 4-year span. Infectious complications were categorized according to severity (local or systemic) and time (periprocedural or late). Results Three hundred ninety-three ports have been indwelling for a total of 97,256 patient days (range, 1–694; mean duration, 247 days). Among the 30 catheter placements in 29 HIV-positive patients with a total exposure time of 7,242 days, five (one local and four systemic) infections occurred, resulting in a 16.6% overall infection rate, yielding 0.069 infections per 100 catheter days at risk (95% confidence interval [CI], 0.032–0.127). In the remaining 362 HIV-negative patients, 27 (14 local and 13 systemic) infectious complications (7.4%) occurred, translating into 0.030 infections per 100 catheter days (95% CI, 0.021–0.042). The odds ratio of getting an infection from the implantable arm ports in the HIV-positive group was 2.5 times higher than that of the HIV-negative group. The relative risk was similar and was calculated to be 2.3. The P value was .084 ( P Conclusions These results suggest a significant difference in the infectious complication rate encountered in HIV-positive patients compared with the general population. However, the HIV-positive peripheral arm port infection rate compares favorably with the surgically placed catheters and ports. Many more arm ports in HIV-positive patients must be evaluated for the data to achieve an acceptable level of statistical significance.

Aortic or brachiocephalic vessel injuries secondary to blunt thoracic trauma are relatively common and can occur throughout the length of the thoracic aorta or in various locations in the brachiocephalic vessels. Aortography remains the standard of reference for the diagnosis of these injuries despite recent technologic advances in other imaging modalities. The classic aortographic finding in aortic or brachiocephalic vessel injury consists of a large false aneurysm, typically protruding from the medial aspect of the aortic isthmus. However, intrathoracic aortic or brachiocephalic vessel injury can and does occur at any intrathoracic location and may exhibit a wide variety of radiographic appearances, thereby presenting a diagnostic challenge even for experienced trauma angiographers. Large false aneurysms may appear oval or rounded, tubular, or asymmetrically globular and may manifest in unusual locations such as the ascending aorta. Although smaller, irregularly shaped false aneurysms at atypical locations may be obscure or mimic ductus diverticula, their irregular, sharp margins allow them to be distinguished as injuries. The subtlety of aortic or brachiocephalic vessel injuries necessitates a high degree of suspicion along with meticulous imaging technique in all cases and the use of additional projections in equivocal cases for definitive diagnosis.

Introduction Many products labeled “herbal” or “all natural” (herbal/natural) that claim to enhance sexual performance and imply use for the treatment of erectile dysfunction (ED) are marketed as over-the-counter (OTC) dietary supplements. However, adulteration with undeclared phosphodiesterase type 5 (PDE5) inhibitors appears widespread. Aim To assess the availability, cost, origin, categorical content, and adulteration with PDE5 inhibitors of purported herbal/natural OTC dietary supplements claiming to naturally enhance sexual performance. Methods Pfizer Global Security coordinated sample collection (all from convenience stores and filling stations in two U.S. metropolitan areas except for seven from U.S. Customs seizures) and liquid chromatography/mass spectrometry examination. Main Outcome Measure Adulteration with synthetic PDE5 inhibitors. Results Ninety-one samples labeled as 58 distinct products and priced from $2.99 to $17.99 were evaluated. Origin/manufacture was claimed as United States (n = 62), apparently Asian (n = 15), and not clearly identified (n = 14). Although no sample claimed to include synthetic substances, 74 (81%) contained PDE5-inhibitor pharmaceutical ingredients, including tadalafil and/or sildenafil (n = 40, of which 18 contained >110% of the highest approved drug product strength) or PDE5-inhibitor analogs (n = 34). Pronounced heterogeneity of contents between samples within individual products indicated minimal quality control during manufacture. Labeling was inadequate (e.g., lacking lot number and/or expiry date) for 17 products (23 samples) and inconsistent between samples within a given product (e.g., in manufacturer, lot number, and/or expiry date) for seven of 17 products having multiple samples. Only 14 samples warned against concomitant nitrate use. Conclusions Ethical pharmaceutical companies are concerned for an unsuspecting public when their products are counterfeited, mislabeled, and illegally offered for sale in an unsafe manner. Because of the dangers of adulteration with synthetic PDE5 inhibitors, absent safety warnings, and lack of quality or consistent manufacture, men with ED unknowingly risk their health by using OTC herbal/natural products that claim to enhance sexual performance. Campbell N, Clark JP, Stecher VJ, Thomas JW, Callanan AC, Donnelly BF, Goldstein I, and Kaminetsky JC. Adulteration of purported herbal and natural sexual performance enhancement dietary supplements with synthetic phosphodiesterase type 5 inhibitors.