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1.
Trop Anim Health Prod ; 54(5): 332, 2022 Sep 30.
Article in English | MEDLINE | ID: mdl-36175571

ABSTRACT

Agricultural use of antimicrobials in food animal production may contribute to the global emergence of antimicrobial resistance (AMR). However, considerable gaps exist in research on the use of antimicrobial drugs (AMDs) in food animals in small-scale production systems in low- and middle-income countries, despite the minimal regulation of antimicrobials in such regions. The aim of this study was to identify factors that may influence AMD use in livestock among pastoral communities in Kenya. We collected data related to household and herd demographics, herd health, and herd management from 55 households in the Maasai Mara ecosystem, Kenya, between 2018 and 2019. We used multi-model logistic regression inference (supervised machine learning) to ascertain trends in AMD use within these households. AMD use in cattle was significantly associated with AMD use in sheep and goats (p = 0.05), implying that decisions regarding AMD use in cattle or sheep and goats were interdependent. AMD use in sheep and goats was negatively associated with vaccination against the foot and mouth disease (FMD) virus in cattle (OR = 0.06, 95% CI 0.01-0.67, p = 0.02). Less AMD use was observed for vaccine-preventable diseases like contagious ecthyma when households had access to state veterinarians (OR = 0.06, p = 0.05, 95% CI 0.004-0.96). Overall, decisions to use AMDs were associated with vaccine usage, occurrence of respiratory diseases, and access to animal health advice. This hypothesis-generating study suggests that applying community-centric methods may be necessary to understand the use of AMDs in pastoral communities.


Subject(s)
Anti-Infective Agents , Foot-and-Mouth Disease Virus , Veterinarians , Animals , Anti-Infective Agents/therapeutic use , Cattle , Ecosystem , Goats , Humans , Kenya/epidemiology , Sheep
2.
JAMA Netw Open ; 5(3): e224488, 2022 03 01.
Article in English | MEDLINE | ID: mdl-35353168

ABSTRACT

Importance: Although iron deficiency is common, it remains unclear which iron repletion strategy is associated with the lowest rate of infusion-related adverse events, and how patients with history of infusion reaction should be managed. Objective: To evaluate rates of infusion reactions among 4 commonly used intravenous iron repletion strategies and determine how readministration was managed in patients with history of reaction. Design, Setting, and Participants: This cohort study included all patients receiving intravenous iron infusion from January 1, 2015, to September 7, 2021, at 6 centers in Portland, Oregon. Participants included a total of 12 237 patients with iron deficiency, not restricted by etiology. Statistical analysis was performed from September to October 2021. Exposures: Type of intravenous iron formulation and concurrent administration of diphenhydramine, epinephrine, famotidine, and/or hydrocortisone, used as surrogate maker of infusion reaction. Main Outcomes and Measures: Incidence of adverse events, including severe events requiring epinephrine, stratified by type of iron formulation, and in patients who received premedication or with history of infusion-related reaction receiving subsequent doses. Results: Among 35 737 unique iron infusions (12 237 patients [9480 (77.5%) women; 717 (5.9%) Black; 10 250 (83.7%) White; mean (SD) age of 51 (20) years]), comprising 22 309 iron sucrose doses, 9067 iron dextran total doses (1771 preceded by test dose, 56 test doses alone), 3147 ferumoxytol doses, and 1214 ferric carboxymaltose doses, incidence of adverse events was 3.9% (n = 1389; 95% CI, 3.7%-4.1%). Rate of infusion events differed among iron formulations: 4.3% (n = 970; 95% CI, 4.1%-4.6%) iron sucrose, 3.8% (n = 345, 95% CI: 3.4%-4.2%) iron dextran (test and full doses or test dose alone), 1.8% (n = 57; 95% CI, 1.4%-2.3%) ferumoxytol, and 1.4% (n = 17, 95% CI, 0.8%-2.3%) ferric carboxymaltose (P < .001). Severe adverse events were exceedingly rare with only 2 documented epinephrine administrations, both associated with iron dextran. Incidence of adverse events among those who received premedication was 23-fold higher compared with those who did not (38.6% vs 1.7%, χ21 = 7324.8; P < .001). Among 873 patients with history of infusion reaction who underwent readministration, the majority received the same formulation, which was associated with significantly higher reaction rate particularly if premedication was administered (68% [95% CI, 64%-72%] vs 32% [95% CI, 26%-41%], respectively), compared with those who received an alternate formulation (21% [95% CI, 11%-35%] vs 5% [95% CI, 2%-12%], respectively) (P < .001). Conclusions and Relevance: These data, and the preponderance of published evidence, suggest that intravenous iron is generally well tolerated with exceedingly low risk of severe reaction, use of premedication and test doses are unnecessary, and that optimal prevention and management of infusion-related reactions warrant further study.


Subject(s)
Ferrosoferric Oxide , Iron , Administration, Intravenous , Adult , Cohort Studies , Female , Ferrosoferric Oxide/adverse effects , Humans , Infusions, Intravenous , Iron/adverse effects , Male , Middle Aged
3.
Platelets ; 33(4): 570-576, 2022 May 19.
Article in English | MEDLINE | ID: mdl-34355646

ABSTRACT

Extracorporeal membrane oxygenation (ECMO) provides lifesaving circulatory support and gas exchange, although hematologic complications are frequent. The relationship between ECMO and severe thrombocytopenia (platelet count <50 × 109/L) remains ill-defined. We performed a cohort study of 67 patients who received ECMO between 2016 and 2019, of which 65.7% received veno-arterial (VA) ECMO and 34.3% received veno-venous (VV) ECMO. All patients received heparin and 25.4% received antiplatelet therapy. In total, 23.9% of patients had a thrombotic event and 67.2% had a hemorrhagic event. 38.8% of patients developed severe thrombocytopenia. Severe thrombocytopenia was more common in patients with lower baseline platelet counts and increased the likelihood of thrombosis by 365% (OR 3.65, 95% CI 1.13-11.8, P = .031), while the type of ECMO (VA or VV) was not predictive of severe thrombocytopenia (P = .764). Multivariate logistic regression controlling for additional clinical variables found that severe thrombocytopenia predicted thrombosis (OR 3.65, CI 1.13-11.78, P = .031). Over a quarter of patients requiring ECMO developed severe thrombocytopenia in our cohort, which was associated with an increased risk of thrombosis and in-hospital mortality. Additional prospective observation is required to clarify the clinical implications of severe thrombocytopenia in the ECMO patient population.


Subject(s)
Extracorporeal Membrane Oxygenation , Thrombocytopenia , Thrombosis , Adult , Anticoagulants/therapeutic use , Cohort Studies , Extracorporeal Membrane Oxygenation/adverse effects , Humans , Prospective Studies , Retrospective Studies , Thrombocytopenia/chemically induced , Thrombocytopenia/therapy , Thrombosis/drug therapy , Thrombosis/etiology
4.
Thromb Res ; 207: 96-98, 2021 Sep 20.
Article in English | MEDLINE | ID: mdl-34592628

ABSTRACT

Erythrocytosis is a well-recognized consequence of exogenous testosterone, however its prevalence and contributions to thrombosis remain unknown in the context of gender-affirming hormonal therapy. We undertook a retrospective study of transgender and non-binary (TGNB) adults receiving exogenous testosterone. In the retrospective sample, 923 transgender individuals receiving testosterone were identified with 519 having documented pre- and post-testosterone hemoglobin and hematocrit (Hgb/Hct). The mean peak Hgb/Hct was 15.7 g/dL, and 47.0%. Mean time-to-peak Hgb/Hct was 31.2 months; 7.8% developed a hemoglobin >17.5 g/dL, whereas 20% developed a hematocrit of >50%. Testosterone dose reduction occurred in 42% of patients with erythrocytosis and 4.8% underwent phlebotomy. Thromboembolic events occurred in 0.9%, of which 80% had developed erythrocytosis by either Hgb or Hct, including two cases each of superficial and calf vein thrombosis as well as one ischemic stroke. We then performed an analysis of 14,294,784 hospitalizations from the 2016-17 US National Inpatient Sample (NIS), which identified 4141 admissions involving transgender individuals. Of those, seven had erythrocytosis with one concurrent venous thromboembolic event. Hematocrit >50% occurs in up to 20% of transgender individuals receiving testosterone. Despite the high incidence of erythrocytosis, thromboembolic events and hospitalizations involving erythrocytosis were uncommon.

5.
Neuro Endocrinol Lett ; 42(3): 200-212, 2021 Jul.
Article in English | MEDLINE | ID: mdl-34279863

ABSTRACT

BACKGROUND: Emotionally unstable personality disorder (EUPD) is a challenging condition with a prevalence of 20% in inpatient services. Psychotherapy is the preferred treatment; nevertheless, off-license medications are widely used. OBJECTIVES: To identify socio-demographics, clinical and service-delivery characteristics of people with EUPD admitted to inpatient services between 1st January 2017 and 31st December 2018. METHODS: A retrospective review using data from patients' records. Individuals, age 18-65 were included. Statistical analysis was conducted by the Mann-Whitney-Wilcoxon test and Chi-squared test with Yates's continuity correction. RESULTS: Of 1646 inpatients, 201 (12.2%); had the diagnosis of EUPD; 133 (66.0%) women, 68 (44.0%). EUPD was significantly (P < .001) more prevalent in women (18.2%) than men (7.4%). EUPD patients were significantly (P < .001) younger (32.2 years) than patients without EUPD (46 years), and had significantly (P < .001) more admissions (1.74) than patients without EUPD (1.2 admission). 70.5% of patients had one and 17.0% two Axis-I psychiatric co-morbidities. Substance use was significantly (P < .001) more often in men (57.3%) than in women (28.5%). Significantly (P = 0.047) more women (68.4%) than men (53.0%) reported sexual abuse. 87.5% used polypharmacy. Antidepressants were significantly (P = 0.02) often prescribed to women (76.6%) than men (69.1%). Significantly (P = 0.02) more women (83.5%) than men (67.6%) were on antipsychotics. 57.2% of the patients were on anxiolytics, 40.0% on hypnotics and 25.8% on mood stabilisers. CONCLUSION: EUPD is a complex condition with widespread comorbidity. The term EUPD, Borderline Personality Disorder is unsuitable, stigmatising and too simplistic to reflect the nature, gravity and psychopathology of this syndrome.


Subject(s)
Borderline Personality Disorder , Inpatients , Adolescent , Adult , Aged , Borderline Personality Disorder/drug therapy , Borderline Personality Disorder/epidemiology , Comorbidity , Female , Humans , Male , Middle Aged , Psychotherapy , Retrospective Studies , Young Adult
6.
ASAIO J ; 67(8): 899-906, 2021 08 01.
Article in English | MEDLINE | ID: mdl-33528163

ABSTRACT

Extracorporeal membrane oxygenation (ECMO) protocols generally require systemic anticoagulation with heparin to prevent circuit thrombosis. The prevalence, risk factors, and outcomes of heparin resistance in this setting are ill-defined. To better understand the prevalence and clinical consequences of heparin resistance in this population, we conducted a retrospective analysis of all patients treated with ECMO at a single academic medical center between 2016 and 2019. Univariate and multivariate analyses were used to evaluate predictors and outcomes of heparin resistance. Of 67 patients in our study, 50.7% met the threshold for heparin resistance for at least 1 day, which was managed in all cases with increases in heparin dose. Patients with heparin resistance were more likely to be male (82.4% vs. 48.5%, p = 0.005) and to have a higher mean platelet count (132 vs. 104 × 103/mL, p = 0.027) compared with those without heparin resistance. Multivariate logistic regression found no significant association between the development of heparin resistance and rates of thrombosis, hemorrhage, or overall survival. Additional prospective studies are required to clarify the clinical implications of heparin resistance in this population.


Subject(s)
Extracorporeal Membrane Oxygenation , Anticoagulants/adverse effects , Extracorporeal Membrane Oxygenation/adverse effects , Female , Hemorrhage , Heparin , Humans , Male , Retrospective Studies
7.
Eur J Haematol ; 106(1): 19-31, 2021 Jan.
Article in English | MEDLINE | ID: mdl-32946632

ABSTRACT

Extracorporeal circulatory devices such as hemodialysis and extracorporeal membrane oxygenation can be lifesaving; however, they are also prone to pathologic events including device failure, venous and arterial thrombosis, hemorrhage, and an accelerated risk for atherosclerotic disease due to interactions between blood components and device surfaces of varying biocompatibility. While extracorporeal devices may be used acutely for limited periods of time (eg, extracorporeal membrane oxygenation, continuous venovenous hemofiltration, therapeutic apheresis), some patients require chronic use of these technologies (eg, intermittent hemodialysis and left ventricular assist devices). Given the substantial thrombotic risks associated with extracorporeal devices, multiple antiplatelet and anticoagulation strategies-including unfractionated heparin, low-molecular-weight heparin, citrate, direct thrombin inhibitors, and direct oral anticoagulants, have been used to mitigate the thrombotic milieu within the patient and device. In the following manuscript, we outline the current data on anticoagulation strategies for commonly used extracorporeal circulatory devices, highlighting the potential benefits and complications involved with each.


Subject(s)
Anticoagulants/administration & dosage , Extracorporeal Circulation/instrumentation , Adult , Age Factors , Anticoagulants/adverse effects , Blood Coagulation , Clinical Decision-Making , Disease Management , Duration of Therapy , Extracorporeal Circulation/adverse effects , Extracorporeal Circulation/methods , Hemorrhage/etiology , Humans , Thrombosis/etiology
9.
EGEMS (Wash DC) ; 5(1): 28, 2017 Dec 07.
Article in English | MEDLINE | ID: mdl-29881744

ABSTRACT

Learning health systems use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning. Even without randomization, observational studies can play a central role as the nation's health care system embraces comparative effectiveness research and patient-centered outcomes research. However, neither the breadth, timeliness, volume of the available information, nor sophisticated analytics, allow analysts to confidently infer causal relationships from observational data. However, depending on the research question, careful study design and appropriate analytical methods can improve the utility of EHD. The introduction to a series of four papers, this review begins with a discussion of the kind of research questions that EHD can help address, noting how different evidence and assumptions are needed for each. We argue that when the question involves describing the current (and likely future) state of affairs, causal inference is not relevant, so randomized clinical trials (RCTs) are not necessary. When the question is whether an intervention improves outcomes of interest, causal inference is critical, but appropriately designed and analyzed observational studies can yield valid results that better balance internal and external validity than typical RCTs. When the question is one of translation and spread of innovations, a different set of questions comes into play: How and why does the intervention work? How can a model be amended or adapted to work in new settings? In these "delivery system science" settings, causal inference is not the main issue, so a range of quantitative, qualitative, and mixed research designs are needed. We then describe why RCTs are regarded as the gold standard for assessing cause and effect, how alternative approaches relying on observational data can be used to the same end, and how observational studies of EHD can be effective complements to RCTs. We also describe how RCTs can be a model for designing rigorous observational studies, building an evidence base through iterative studies that build upon each other (i.e., confirmation across multiple investigations).

10.
EGEMS (Wash DC) ; 5(1): 29, 2017 Dec 07.
Article in English | MEDLINE | ID: mdl-29881745

ABSTRACT

The second paper in a series on how learning health systems can use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning, this review summarizes study design approaches, including choosing appropriate data sources, and methods for design and analysis of natural and quasi-experiments. The primary strength of study design approaches described in this section is that they study the impact of a deliberate intervention in real-world settings, which is critical for external validity. These evaluation designs address estimating the counterfactual - what would have happened if the intervention had not been implemented. At the individual level, epidemiologic designs focus on identifying situations in which bias is minimized. Natural and quasi-experiments focus on situations where the change in assignment breaks the usual links that could lead to confounding, reverse causation, and so forth. And because these observational studies typically use data gathered for patient management or administrative purposes, the possibility of observation bias is minimized. The disadvantages are that one cannot necessarily attribute the effect to the intervention (as opposed to other things that might have changed), and the results do not indicate what about the intervention made a difference. Because they cannot rely on randomization to establish causality, program evaluation methods demand a more careful consideration of the "theory" of the intervention and how it is expected to play out. A logic model describing this theory can help to design appropriate comparisons, account for all influential variables in a model, and help to ensure that evaluation studies focus on the critical intermediate and long-term outcomes as well as possible confounders.

11.
EGEMS (Wash DC) ; 5(1): 30, 2017 Dec 07.
Article in English | MEDLINE | ID: mdl-29881746

ABSTRACT

The third paper in a series on how learning health systems can use routinely collected electronic health data (EHD) to advance knowledge and support continuous learning, this review describes how analytical methods for individual-level electronic health data EHD, including regression approaches, interrupted time series (ITS) analyses, instrumental variables, and propensity score methods, can also be used to address the question of whether the intervention "works." The two major potential sources of bias in non-experimental studies of health care interventions are that the treatment groups compared do not have the same probability of treatment or exposure and the potential for confounding by unmeasured covariates. Although very different, the approaches presented in this chapter are all based on assumptions about data, causal relationships, and biases. For instance, regression approaches assume that the relationship between the treatment, outcome, and other variables is properly specified, all of the variables are available for analysis (i.e., no unobserved confounders) and measured without error, and that the error term is independent and identically distributed. The instrumental variables approach requires identifying an instrument that is related to the assignment of treatment but otherwise has no direct on the outcome. Propensity score methods approaches, on the other hand, assume that there are no unobserved confounders. The epidemiological designs discussed also make assumptions, for instance that individuals can serve as their own control. To properly address these assumptions, analysts should conduct sensitivity analyses within the assumptions of each method to assess the potential impact of what cannot be observed. Researchers also should analyze the same data with different analytical approaches that make alternative assumptions, and to apply the same methods to different data sets. Finally, different analytical methods, each subject to different biases, should be used in combination and together with different designs, to limit the potential for bias in the final results.

12.
J Am Vet Med Assoc ; 248(12): 1404-13, 2016 Jun 15.
Article in English | MEDLINE | ID: mdl-27270064

ABSTRACT

OBJECTIVE To develop a cattle herd risk-profiling system that could potentially inform risk-based surveillance strategies for Mycobacterium bovis infection in cattle and provide information that could be used to help direct resource allocation by a state agency for this purpose. DESIGN Cross-sectional study. SAMPLE Records for any size movement (importation) of cattle into Minnesota from other US states during 2009 (n = 7,185) and 2011 (8,107). PROCEDURES Data from certificates of veterinary inspection were entered into a spreadsheet. Movement data were summarized at premises and county levels, and for each level, the distribution of cattle moved and number of movements were evaluated. Risk profiling (assessment and categorization of risk for disease introduction) for each import movement was performed on the basis of known risk factors. Latent class analysis was used to assign movements to risk classifications with adjustment on the basis of expert opinions from personnel knowledgeable about bovine tuberculosis; these data were used to classify premises as very high, high, medium, or low risk for disease introduction. RESULTS In each year, approximately 1,500 premises imported cattle, typically beef and feeder types, with the peak of import movements during the fall season. The risk model identified 4 risk classes for cattle movements. Approximately 500 of the estimated 27,406 (2%) cattle premises in Minnesota were in the very high or high risk groups for either year; greatest density of these premises was in the southeast and southwest regions of the state. CONCLUSIONS AND CLINICAL RELEVANCE A risk-profiling approach was developed that can be applied in targeted surveillance efforts for bovine tuberculosis, particularly in disease-free areas.


Subject(s)
Animal Husbandry/methods , Cattle Diseases/microbiology , Mycobacterium bovis/isolation & purification , Tuberculosis, Bovine/prevention & control , Animals , Cattle , Cattle Diseases/prevention & control , Models, Biological , Population Surveillance , Risk Factors , Transportation
13.
JMIR Mhealth Uhealth ; 4(2): e35, 2016 Apr 13.
Article in English | MEDLINE | ID: mdl-27076486

ABSTRACT

BACKGROUND: Physical activity contributes to older adults' autonomy, mobility, and quality of life as they age, yet fewer than 1 in 5 engage in activities as recommended. Many older adults track their exercise using pencil and paper, or their memory. Commercially available physical activity monitors (PAM) have the potential to facilitate these tracking practices and, in turn, physical activity. An assessment of older adults' long-term experiences with PAM is needed to understand this potential. OBJECTIVE: To assess short and long-term experiences of adults >70 years old using a PAM (Fitbit One) in terms of acceptance, ease-of-use, and usefulness: domains in the technology acceptance model. METHODS: This prospective study included 95 community-dwelling older adults, all of whom received a PAM as part of randomized controlled trial piloting a fall-reducing physical activity promotion intervention. Ten-item surveys were administered 10 weeks and 8 months after the study started. Survey ratings are described and analyzed over time, and compared by sex, education, and age. RESULTS: Participants were mostly women (71/95, 75%), 70 to 96 years old, and had some college education (68/95, 72%). Most participants (86/95, 91%) agreed or strongly agreed that the PAM was easy to use, useful, and acceptable both 10 weeks and 8 months after enrolling in the study. Ratings dropped between these time points in all survey domains: ease-of-use (median difference 0.66 points, P=.001); usefulness (median difference 0.16 points, P=.193); and acceptance (median difference 0.17 points, P=.032). Differences in ratings by sex or educational attainment were not statistically significant at either time point. Most participants 80+ years of age (28/37, 76%) agreed or strongly agreed with survey items at long-term follow-up, however their ratings were significantly lower than participants in younger age groups at both time points. CONCLUSIONS: Study results indicate it is feasible for older adults (70-90+ years of age) to use PAMs when self-tracking their physical activity, and provide a basis for developing recommendations to integrate PAMs into promotional efforts. TRIAL REGISTRATION: Clinicaltrials.gov NCT02433249; https://clinicaltrials.gov/ct2/show/NCT02433249 (Archived by WebCite at http://www.webcitation.org/6gED6eh0I).

14.
Am J Addict ; 22(3): 218-25, 2013.
Article in English | MEDLINE | ID: mdl-23617862

ABSTRACT

BACKGROUND AND OBJECTIVES: The aim of the study was to estimate prevalence rates of pathological gambling and problem gambling among veterans receiving VA care, since several studies have suggested that VA patients may be at increased risk to these conditions. SAMPLE: consisted of 1,999 veterans randomly selected from VA centers and community clinics in the Albuquerque and Minneapolis catchment areas. Women and younger veterans were oversampled, due to anticipated low rates in these two groups. RESULTS: revealed that the lifetime prevalence rate of pathological gambling weighted for current VA patients was 2.0%, twice the general adult population rate. Current 1-year weighted prevalence of pathological gambling was .9%, with an additional .2% having continued problem gambling and .9% recovered. Lifetime weighted problem gambling rate was 8.8%. Altogether, 10.7% had lifetime pathological gambling or problem gambling. Women had higher rates of pathological gambling, but similar rates of problem gambling compared to men. The greater prevalence of pathological gambling for younger veterans aged 20-29 (1.3%) compared to veterans aged 30-39 (.8%) was unusual and warrants further investigation. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE: Veterans in VA care have higher rates of gambling problems than the general adult population. Female and young veterans have rates higher than those observed in other surveys of women and young adults.


Subject(s)
Gambling/epidemiology , Mental Disorders/epidemiology , Veterans/statistics & numerical data , Adult , Age Factors , Aged , Aged, 80 and over , Comorbidity , Female , Gambling/psychology , Humans , Logistic Models , Male , Middle Aged , Minnesota/epidemiology , New Mexico/epidemiology , Prevalence , Sex Factors , United States , United States Department of Veterans Affairs , Veterans/psychology
15.
BMC Med Inform Decis Mak ; 12 Suppl 1: S6, 2012 Apr 30.
Article in English | MEDLINE | ID: mdl-22595091

ABSTRACT

BACKGROUND: This paper describes the analysis of a database of over 180,000 patient records, collected from over 23,000 patients, by the hearing aid clinic at James Cook University Hospital in Middlesbrough, UK. These records consist of audiograms (graphs of the faintest sounds audible to the patient at six different pitches), categorical data (such as age, gender, diagnosis and hearing aid type) and brief free text notes made by the technicians. This data is mined to determine which factors contribute to the decision to fit a BTE (worn behind the ear) hearing aid as opposed to an ITE (worn in the ear) hearing aid. METHODS: From PCA (principal component analysis) four main audiogram types are determined, and are related to the type of hearing aid chosen. The effects of age, gender, diagnosis, masker, mould and individual audiogram frequencies are combined into a single model by means of logistic regression. Some significant keywords are also discovered in the free text fields by using the chi-squared (χ(2)) test, which can also be used in the model. The final model can act a decision support tool to help decide whether an individual patient should be offered a BTE or an ITE hearing aid. RESULTS: The final model was tested using 5-fold cross validation, and was able to replicate the decisions of audiologists whether to fit an ITE or a BTE hearing aid with precision in the range 0.79 to 0.87. CONCLUSIONS: A decision support system was produced to predict the type of hearing aid which should be prescribed, with an explanation facility explaining how that decision was arrived at. This system should prove useful in providing a "second opinion" for audiologists.


Subject(s)
Audiology/methods , Choice Behavior , Data Mining , Hearing Aids/psychology , Principal Component Analysis , Adult , Aged , Aged, 80 and over , Auditory Threshold , Bayes Theorem , Chi-Square Distribution , Equipment Design , Female , Hearing Tests , Humans , Logistic Models , Male , Middle Aged , Patient Acceptance of Health Care , Perceptual Masking , Tinnitus/psychology , Tinnitus/rehabilitation
16.
Chest ; 140(5): 1274-1283, 2011 Nov.
Article in English | MEDLINE | ID: mdl-21546436

ABSTRACT

BACKGROUND: The long-term safety and tolerability of sildenafil treatment of pulmonary arterial hypertension (PAH) were assessed. METHODS: Two hundred fifty-nine of 277 randomized and treated patients completed a 12-week, double-blind, placebo-controlled trial (SUPER-1 [Sildenafil Use in Pulmonary Arterial Hypertension]) of oral sildenafil in treatment-naive patients with PAH (96% functional class II/III) and entered an open-label uncontrolled extension study (SUPER-2) that continued until the last patient completed 3 years of sildenafil treatment. Patients titrated to sildenafil 80 mg tid; one dose reduction for tolerability was allowed during the titration phase. RESULTS: The median duration of sildenafil treatment across SUPER-1 and SUPER-2 was 1,242 days (range, 1-1,523 days); 170 patients (61%) completed both studies, and 89 patients discontinued from SUPER-2. After 3 years, 87% of 183 patients on treatment were receiving sildenafil 80 mg tid. Of patients remaining under follow-up, 3%, 10%, and 18% were receiving a second approved PAH therapy at 1, 2, and 3 years, respectively. At 3 years post-SUPER-1 baseline, 127 patients had an increased 6-min walk distance (6MWD); 81 improved and 86 maintained functional class. Most adverse events were of mild or moderate severity. At 3 years, 53 patients had died (censored, n = 37). Three-year estimated survival rate was 79%; if all censored patients were assumed to have died, 3-year survival rate was 68%. No deaths were considered to be treatment related. CONCLUSIONS: Long-term treatment of PAH initiated as sildenafil monotherapy was generally well tolerated. After 3 years, the majority of patients (60%) who entered the SUPER-1 trial improved or maintained their functional status, and 46% maintained or improved 6MWD.


Subject(s)
Hypertension, Pulmonary/drug therapy , Piperazines/therapeutic use , Sulfones/therapeutic use , Vasodilator Agents/therapeutic use , Administration, Oral , Adolescent , Adult , Aged , Aged, 80 and over , Double-Blind Method , Female , Humans , Male , Middle Aged , Piperazines/administration & dosage , Piperazines/adverse effects , Placebos , Proportional Hazards Models , Purines/administration & dosage , Purines/adverse effects , Purines/therapeutic use , Sildenafil Citrate , Sulfones/administration & dosage , Sulfones/adverse effects , Survival Rate , Treatment Outcome , Vasodilator Agents/administration & dosage , Vasodilator Agents/adverse effects
17.
Intensive Care Med ; 37(3): 502-9, 2011 Mar.
Article in English | MEDLINE | ID: mdl-21069290

ABSTRACT

PURPOSE: To evaluate the efficacy and safety of intravenous sildenafil for immediate postoperative pulmonary hypertension (PH) in pediatric patients undergoing congenital heart surgery. METHODS: A double-blind, multicenter, placebo-controlled, dose-ranging, parallel-group trial was conducted. Patients were randomized to one of three doses of intravenous sildenafil, or placebo, for a minimum of 24 h. RESULTS: The study was heavily underpowered. Whereas enrollment of 228 patients (57 per treatment arm) was required to achieve the sample size estimate to detect difference between arms, the sponsor terminated the study after 15 months owing to slow patient accrual. Seventeen patients (median age 5 months) experiencing postoperative PH were randomized and treated, five with placebo and four each with low-, medium-, and high-dose sildenafil. In the first 24 h, 40% of placebo and 17% of sildenafil patients required additional therapy (p = 0.330). Median time to extubation (3 versus 8 days, p = 0.023) and intensive care unit stay (6 versus 15 days, p = 0.008) were shorter for sildenafil patients. Mean ± standard deviation systolic pulmonary artery pressure was reduced with sildenafil (46 ± 11 to 35 ± 6 mmHg, p = 0.027 versus placebo). No adverse events or systemic hypotension were attributed to sildenafil. CONCLUSION: Intravenous sildenafil reduced pulmonary artery pressure and shortened time to extubation and intensive care unit stay in children with postoperative PH.


Subject(s)
Heart Defects, Congenital , Hypertension, Pulmonary/drug therapy , Piperazines/pharmacology , Postoperative Complications , Sulfones/pharmacology , Vasodilation/drug effects , Vasodilator Agents/pharmacology , Adolescent , Child , Child, Preschool , Dose-Response Relationship, Drug , Drug-Related Side Effects and Adverse Reactions , Female , Heart Defects, Congenital/surgery , Humans , Infant , Infusions, Intravenous , Male , Piperazines/administration & dosage , Piperazines/pharmacokinetics , Purines/administration & dosage , Purines/pharmacokinetics , Purines/pharmacology , Sildenafil Citrate , Sulfones/administration & dosage , Sulfones/pharmacokinetics , Vasodilator Agents/administration & dosage , Vasodilator Agents/pharmacokinetics
18.
Arch Sex Behav ; 39(5): 1045-53, 2010 Oct.
Article in English | MEDLINE | ID: mdl-19588239

ABSTRACT

The present study explored the relationship between compulsive sexual behavior (CSB) and unprotected anal intercourse (UAI) for men who have sex with men (MSM) across a number of ethnic/racial groups and who used the Internet to seek sexual partners. A sample of 2,716 MSM (512 Asian, 445 Black, 683 Latino, 348 Other, 728 White) completed on online survey that collected information about their sexual behaviors with partners met online and offline. The survey also included the Compulsive Sexual Behavior Inventory (CSBI). Consistent with the notion that CSB is a stable trait, higher scores on the CSBI were associated with greater odds for engaging in UAI, regardless of the context in which sex partners were met (online or offline). Differences in median CSB scores were generally similar across racial and ethnic groups. The median CSB score was significantly higher for HIV-positive participants than for HIV-negative participants. HIV-prevention interventions are needed among MSM, but should take into account that some may be resistant to risk reduction strategies because of CSB.


Subject(s)
Compulsive Behavior/psychology , Homosexuality, Male/statistics & numerical data , Internet , Sexual Behavior/statistics & numerical data , Unsafe Sex/statistics & numerical data , Adolescent , Adult , Aged , Aged, 80 and over , HIV Infections/prevention & control , Health Surveys , Homosexuality, Male/psychology , Humans , Male , Men/psychology , Middle Aged , Risk Factors , Risk-Taking , Sexual Behavior/psychology , Surveys and Questionnaires , Unsafe Sex/psychology
19.
J Pediatr ; 155(6): 841-847.e1, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19836028

ABSTRACT

OBJECTIVE: To evaluate the safety of intravenous (IV) sildenafil, an inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase, in treating near-term and term newborns with persistent pulmonary hypertension of the newborn (PPHN). STUDY DESIGN: This was an open-label, dose-escalation trial in newborns with PPHN and an oxygenation index (OI) > 15. Sildenafil was delivered by continuous IV infusion for at least 48 hours and up to 7 days. RESULTS: Five centers enrolled a total of 36 neonates with PPHN at a mean of 34 +/- 17 hours of age; 29 of these neonates were already receiving inhaled nitric oxide (iNO). A significant improvement in OI (28.7 to 19.3; P = .0002) was observed after 4 hours of sildenafil infusion in the higher dose cohorts. Thirty-five neonates survived; 1 neonate required extracorporeal membrane oxygenation (ECMO) support. In 4 neonates, sildenafil was stopped due to adverse events. Seven neonates were enrolled before developing the need for iNO. In these neonates, OI improved significantly by 4 hours after initiation of sildenafil infusion (24.6 to 14.7; P = .009); 6 neonates completed treatment without the need for iNO or ECMO. CONCLUSIONS: IV sildenafil was well tolerated, and acute and sustained improvements in oxygenation were noted in those neonates who received the higher infusion doses.


Subject(s)
Persistent Fetal Circulation Syndrome/drug therapy , Phosphodiesterase Inhibitors/administration & dosage , Piperazines/administration & dosage , Sulfones/administration & dosage , Cohort Studies , Dose-Response Relationship, Drug , Female , Humans , Infant , Infant, Newborn , Infusions, Intravenous , Male , Persistent Fetal Circulation Syndrome/metabolism , Persistent Fetal Circulation Syndrome/physiopathology , Phosphodiesterase Inhibitors/pharmacokinetics , Pilot Projects , Piperazines/pharmacokinetics , Pulmonary Gas Exchange , Purines/administration & dosage , Purines/pharmacokinetics , Sildenafil Citrate , Sulfones/pharmacokinetics , Treatment Outcome
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