Trends in the prevalence and incidence of Crohn's disease in Japan and the United States.

PURPOSE: This study is to describe patient demographic characteristics and estimate annual prevalence and incidence rates of Crohn's disease (CD) in Japan and the United States (US). METHODS: Two large employment-based healthcare claims databases (Japan Medical Data Center [JMDC] in Japan and Merative MarketScan [Merative] in the US) were used to identify patients with CD from 2010 to 2019. Cases were confirmed using an algorithm based on diagnostic with/without treatment codes. The Merative population was used for sex and age standardization of annual prevalence and incidence rates estimated from the JMDC. RESULTS: Patients with CD were generally younger in Japan than in the US at diagnosis (mean 33.6 vs. 39.4 years) and 71.5% were male versus 45.1% in the US. Annual prevalence per 100,000 population increased substantially in both countries, from 34.2 in 2010 to 54.5 in 2019 in Japan (standardized) and 163.3 to 224.2 in the US. Prevalence rates increased in both males and females in all age groups between 6 and < 65 years. Annual incidence rate per 100,000 person-years was almost fourfold higher in the US than Japan (21.0 vs. 5.5 [standardized] in 2019) but remained stable in both countries over time in both sexes and in all age groups. CONCLUSION: The epidemiology of CD differs between Japan and the US. Research to understand the basis of these differences could help to identify at-risk groups in each country, and guide implementation of preventive measures.

Trends in the prevalence and incidence of ulcerative colitis in Japan and the US.

PURPOSE: To estimate and compare annual prevalence and incidence, and demographic characteristics of patients with ulcerative colitis (UC) in Japan and the United States (US). METHODS: All patients with UC were identified from large employment-based healthcare claims databases (Japan Medical Data Center [JMDC] in Japan and IBM MarketScan Commercial Claims and Encounters database [CCAE] in the US), from 2010 to 2019. Cases were confirmed using International Classification of Disease-9/10 codes with/without Anatomical Therapeutic Chemical codes. Annual age-standardized prevalence and incidence rates were estimated for the JMDC by direct standardization using the CCAE as the standard population. RESULTS: Patients with UC were younger in Japan than in the US and men were affected more than women, whereas the reverse was true in the US. Annual prevalence per 100,000 population increased significantly from 5 in 2010 to 98 in 2019 in Japan and from 158 to 233 in the US. Prevalence increased in men more than in women and in all age groups in Japan, whereas increases were observed similarly in men and women, and in the 6 to < 65-year age groups in the US. Annual incidence per 100,000 person-years increased significantly over time in both sexes and in all age groups in Japan, with higher increases in women and in ≥ 18 year-olds. UC incidence rates did not change over time in the US. CONCLUSION: Ten-year trends in epidemiology of UC differ between Japan and the US. The data point to a growing disease burden in both countries that warrants investigation of measures for prevention and treatment.

Baseline risk characterization of early versus later adopters of long-acting paliperidone palmitate formulations.

Early Post-Marketing Phase Vigilance (EPPV) is a unique system that encourages reporting of serious adverse reactions for medications newly introduced to Japan. When a once-monthly paliperidone palmitate formulation (PP1M) was introduced in Japan in 2013, EPPV detected a signal of increased mortality, but this signal was not subsequently confirmed. To clarify whether that signal reflected increased adverse event reporting or an atypically high baseline mortality risk among early adopters of PP1M, we evaluated the baseline risk characteristics of early, mid, and later adopters of PP1M in a Japanese database and did a similar evaluation of PP1M and the three-monthly formulation (PP3M) in two US databases. In Japan, early adopters compared with later adopters were older (mean 39.16 vs 33.70 years) but had a lower proportion of male patients (32.0% vs 44.44%), and a lower mean number of antipsychotic medications (distinct active medical substances) other than paliperidone (2.62 vs 2.85). In the United States, the baseline characteristics of early adopters of PP1M and PP3M did not suggest higher mortality risk than later adopters. These results offer no convincing evidence that the unconfirmed early signal of increased mortality with PP1M was due to increased baseline mortality risk among early adopters.

Effect of obesity on the effectiveness of hormonal contraceptives: an individual participant data meta-analysis.

OBJECTIVE: The objective of this investigation was to assess the potential effect of obesity on the effectiveness of hormonal contraceptives (HCs). STUDY DESIGN: A meta-analysis was conducted using individual participant data directly from the Phase 3 clinical trials of combination oral contraceptives (COCs) rather than extracting summary data from literature. Trials selected were reviewed by the US Food and Drug Administration (FDA) between 2000 and 2012, conducted in North America, had more than six 28-day cycle equivalents of exposure, and had readily retrievable participant-level data. Contraceptive effectiveness was measured by the Pearl Index (PI: the number of pregnancies per 100 woman-years) in women aged 18-35 at risk of unintended pregnancy. The incidence rate ratio (IRR), a ratio of PIs for obese women (defined as body mass index [BMI] ≥30 kg/m(2)) compared to non-obese women (BMI <30 kg/m(2)) was calculated. A Cox proportional-hazard regression model with fixed and random-effects were used to estimate hazard ratios (HRs) for unintended pregnancy in obese women compared to non-obese women. RESULTS: Seven clinical trials with COCs (N=14,024: 2707 obese and 11,317 non-obese women) met the inclusion criteria for the meta-analysis. The PI for each trial varied: 2.05-5.08 for obese and 1.84-3.80 for non-obese women. The pooled PI estimated using direct weighted average method was 3.14 (95% CI: 2.33-4.22) for obese and 2.53 (95% CI: 1.88-3.41) for non-obese women. The pooled IRRs estimated using direct weighted average and Mantel-Haenszel adjustment methods were comparable: 1.37 (95% CI: 1.02-1.84) and 1.43 (95% CI: 1.07-1.92), respectively. The overall HR of 1.44 (95% CI: 1.06-1.95; p=.018) in the meta-analysis suggested a 44% higher pregnancy rate during COC use for obese women after adjusting for age and race. IMPLICATIONS STATEMENT: Obesity may increase the risk of unintended pregnancy in women using COCs; more data on obese women from ongoing and future Phase 3 clinical trials are necessary to allow further evaluation of this topic. CONCLUSIONS: Results of this meta-analysis suggest that obese women may have a higher pregnancy rate during COC use compared to non-obese women. Future analysis should assess differences in pharmacodynamics or compliance that could potentially account for the observed difference in unintended pregnancy rates.

Social Support and Human Immunodeficiency Virus-Status Disclosure to Friends and Family: Implications for Human Immunodeficiency Virus-Positive Youth.

PURPOSE: The fear of negative reactions from friends and family members affects many human immunodeficiency virus (HIV)-positive adolescents' decisions regarding disclosure of their HIV status. The complex relationships and interplay among social support, fear of stigma, and disclosure of HIV status need to be better understood among youth living with HIV (YLHIV). METHODS: Social support from friends and family members and HIV status disclosure were examined among 402 youth, aged 12-24 years, living with HIV. RESULTS: In separate analyses, (1) HIV-positive youth who reported more than one close friend and (2) HIV-positive youth who reported that friends and family members continued to socialize with them after disclosure of their HIV diagnosis, had higher levels of perceived social support overall (both p < .05). Furthermore, perceived social support did not differ significantly between those participants for whom no family member knew their HIV status and those for whom at least one family member knew their status (p = .13). Race/ethnicity, sexual orientation, education level, and current living situation were not associated with family's knowledge of the participants' HIV infection status (p > .07). CONCLUSION: This investigation adds important information concerning YLHIV, whose early disclosure experiences may influence their resilience and future coping mechanisms regarding experienced stigma, and thus influence the length of time they conceal their HIV status, their decision to disclose their status, and potentially their decisions regarding treatment. Interventions and support systems to assist YLHIV with disclosure, as well as medical care, may improve their overall quality of life.

Asthma treatment decisions by pediatric residents do not consistently conform to guidelines or improve with level of training.

OBJECTIVE: To compare asthma treatment decisions by pediatric residents to current asthma guidelines and to learn whether treatment decisions vary by postgraduate year in training. METHODS: We conducted a Web-based survey of residents from 10 training programs through the Continuity Research Network of the Academic Pediatric Association (CORNET). Surveys included 6 vignettes of patients receiving low-dose inhaled steroids with guideline- and non-guideline-based indicators of asthma status and 1 stable patient on high-intensity medication. RESULTS: There were 369 resident respondents (65% response rate), 26% postgraduate year (PGY) 1, 38% PGY2, and 36% PGY3+. Seventy-five percent of each resident group reported seeing fewer than 1 asthma patient per continuity clinic session. A majority of residents made appropriate treatment recommendations in 2 of 4 vignettes of guideline-based indicators of asthma status: first, 97% overall stepping up treatment for mild persistent asthma; and second, 52% overall stepping down treatment for a patient with well-controlled asthma on high-intensity medications. Inconsistent with guideline recommendations, 82% of residents overall did not step down treatment for a patient with well-controlled asthma receiving low-intensity therapy; 75% of residents did not step up treatment for a patient with a recent hospitalization for asthma. Of the 3 vignettes evaluating non-guideline-based indicators of asthma status, a majority of residents (60%) stepped up treatment for parental reports of worse asthma, while a minority did so for a parental report of being bothered by their child's asthma (27%) or when wheezing was reported at physical examination (43%). There were no statistically significant differences for any of the comparisons by year in training. CONCLUSIONS: Pediatric residents' management of asthma is consistent with national guidelines in some cases but not in others. There were no differences in the outpatient asthma management decisions between residents by years in training. Educational efforts should be focused on strategies to facilitate pediatric resident adherence to national asthma guideline recommendations for outpatient asthma management.

Abdominally based free flap planning in breast reconstruction with computed tomographic angiography: systematic review and meta-analysis.

BACKGROUND: Computed tomographic angiography is often used for preoperative mapping. The authors aimed to systematically assess breast reconstruction outcomes after abdominally based free flaps planned with preoperative computed tomographic angiography versus Doppler ultrasonography. METHODS: A search of the PubMed, EMBASE, and Scopus databases and an additional hand-search of relevant articles until June of 2012 rendered 442 English-language citations. Three authors independently reviewed these citations and included all the studies comparing preoperative computed tomographic angiography versus Doppler ultrasonography with regard to short-term postoperative outcomes and operative times. A meta-analysis was performed to evaluate the incidence of flap-related complications (seven studies), donor-site morbidity (four studies), and operative times (five studies) between preoperative computed tomographic angiography and Doppler ultrasonography. A pooled relative risk was calculated using a random-effect model to compare complication rates between the computed tomographic angiography and Doppler ultrasonography groups. RESULTS: A total of 13 studies met inclusion criteria. Preoperative computed tomographic angiography was associated with significantly fewer flap-related complications (relative risk, 0.87; 95 percent CI, 0.78 to 0.97), reduced donor-site morbidity (relative risk, 0.84; 95 percent CI, 0.76 to 0.94), and shorter reconstruction operative time by 87.7 minutes (mean difference, 87.7 minutes; 95 percent CI, 78.3 to 97.1 minutes). CONCLUSIONS: The use of preoperative computed tomographic angiography reduces the operative time, postoperative flap-related complications, and donor-site morbidity compared with Doppler ultrasonography. Preoperative computed tomographic angiography has the potential to reduce operative cost and increase efficiency in the operating room. Thus, preoperative mapping by computed tomographic angiography should be strongly considered for abdominally based free flap breast reconstruction.

Patient-Reported Assessment of Functional Gait Outcomes following Superior Gluteal Artery Perforator Reconstruction.

BACKGROUND: Harvesting the superior gluteal artery perforator (SGAP) flap involves dissection of vessels through the gluteal muscle, potentially compromising gait and ambulation. We compared patient-reported gait and ambulation problems between SGAP flap and deep inferior epigastric perforator (DIEP) flap reconstructions. METHODS: Forty-three patients who underwent bilateral free flap breast reconstruction (17 SGAP, 26 DIEP) participated in the study. The Lower Extremity Functional Score (LEFS) was administered with a supplementary section evaluating gait, balance, fatigue, and pain. Patients evaluated how they felt 2 months postoperatively and at time of survey administration. Multivariate regressions were fit to assess association between type of reconstruction and self-reported lower extremity function controlling for potential confounding factors. RESULTS: Although there was no significant difference in overall LEFS between the cohorts on the date of survey, the SGAP patients reported greater difficulty performing the following activities after surgery (P < 0.05): work, usual hobbies, squatting, walking a mile, walking up stairs, sitting for an hour, running, turning, and hopping. The SGAP patients also reported easier fatigue (P < 0.01) both during the early postoperative period and on the date of survey. CONCLUSIONS: SGAP flap surgery causes no statistically significant differences in overall LEFS. However, SGAP patients did report donor-site morbidity with decreased ability to perform certain activities and increased fatigue and pain in the longer follow-up period. We feel that patients should be educated regarding gait issues and undergo physical therapy during the early postoperative period.

Pilot programme using social network interviews to screen high-risk adolescents and young adults.

OBJECTIVE: To describe a pilot programme that consisted of identifying, contacting and providing HIV testing to members of social and sexual networks of HIV-infected youth patients as a part of routine clinical care at an adolescent HIV clinic in Baltimore, Maryland, USA. METHODS: Forty-nine sexually active HIV-infected adolescent patients were interviewed about their social and sexual contacts at a routine HIV clinic visit. A trained community health worker located these referred social and sexual contacts, and encouraged them to make an appointment for HIV counselling, testing and referral (CTR) services. RESULTS: During a period of 18 months, 26 index youths provided locating information on 53 first-generation contacts and these 53 contacts provided information on 16 second-generation contacts. A total of 32 contacts received counselling services and 25 were tested for HIV infection, yielding three new HIV-positive individuals. CONCLUSION: As a part of standard care for regular visits of HIV-infected youth patients, interviewing about their social and sexual contacts could be a viable strategy in identifying high-risk youths for HIV infection and subsequent CTR services.

Identification of HIV-infected 12- to 24-year-old men and women in 15 US cities through venue-based testing.

OBJECTIVE: To test whether "venue-based testing" could identify human immunodeficiency virus (HIV) infection in US youth, 12 to 24 years of age, who were otherwise not aware of their infection. Racial and ethnic minority women and men who have sex with men (WSM and MSM) compose the majority of new HIV cases among adolescents and young adults. DESIGN: Cross-sectional study. SETTING: Selected venues in communities surrounding the 15 Adolescent Trials Network for HIV/AIDS Interventions (ATN) clinical sites over a 3-month period. PARTICIPANTS: At each venue, ATN sites recruited 20 to 30 English- or Spanish-speaking at-risk youth (12 to 24 years of age), resulting in a total of 1217 study participants, including 611 MSM and 606 WSM. Intervention Venue-based HIV testing with 2 components: an anonymous audio computer-assisted self-administered interview and an anonymous HIV antibody assay. MAIN OUTCOME MEASURE: The prevalence of HIV infection in MSM and WSM. RESULTS: The prevalence of HIV infection in MSM and WSM was 15.3% and 0.3%, respectively. Sixty percent of the MSM and 100% of the WSM claimed to not know of their infection. CONCLUSION: Venue-based testing may be an important strategy to identify HIV-infected younger MSM; however, other strategies are needed for WSM.

Concordance in perceived partner types and unprotected sex among couples of adolescents and young adults: analysis of reciprocally nominated heterosexual dyads.

OBJECTIVES: The objectives of this study were to examine the reciprocity of adolescents' heterosexual relationships, the concordance in perceived partner types reported by partners among reciprocal dyads, and the association between dyad-level unprotected sex and relationship types. SETTINGS AND METHODS: Data were obtained from the Bayview Network Study (San Francisco, California, USA), designed to examine the prevalence of STI risk behaviours and transmission patterns among adolescents between July 2000 and October 2001. For reciprocal dyads, Kappa statistics was used to determine the level of agreement between partner types reported by two sex partners. Multivariate logistic regressions were used to determine the odds of couple's unprotected sex. RESULTS: A total of 782 unique heterosexual relationships were identified. Less than one-third were reciprocally nominated heterosexual dyads. A total of first observed 211 reciprocal dyads were reported by 198 females and 179 males. Agreement on partner type between adolescents and their sex partners among reciprocal dyads was poor, although main-main concordant relationships were the most frequent group (66.4%). Male partner's age and length of relationship significantly increased the odds of a couple's unprotected sex (adjusted OR=1.4, and 1.2, p<0.05), and male partner's frequency of sex significantly decreased the odds (adjusted OR=0.69, p<0.05). The concordance of partner type by two sex partners was not significantly related to couples' unprotected sex when other covariates were taken into account. CONCLUSIONS: This unique study advances knowledge about individuals' perception of their heterosexual partner types in reported relationships: the majority of adolescent couples were not reciprocally acknowledged, and whether or not two sex partners agreed on partner type did not change the odds of a couple's unprotected sex even among reciprocal dyads.

Electrospinning processed nanofibrous TiO(2) membranes for photovoltaic applications.

We have recently fabricated dye-sensitized solar cells (DSSCs) comprising nanofibrous TiO(2) membranes as electrode materials. A thin TiO(2) film was pre-deposited on fluorine doped tin oxide (FTO) coated conducting glass substrate by immersion in TiF(4) aqueous solution to reduce the electron back-transfer from FTO to the electrolyte. The composite polyvinyl acetate (PVac)/titania nanofibrous membranes can be deposited on the pre-deposited thin TiO(2) film coated FTO by electrospinning of a mixture of PVac and titanium isopropoxide in N,N-dimethylformamide (DMF). The nanofibrous TiO(2) membranes were obtained by calcining the electrospun composite nanofibres of PVac/titania as the precursor. Spectral sensitization of the nanofibrous TiO(2) membranes was carried out with a ruthenium (II) complex, cis-dithiocyanate-N,N(')-bis(2,2(')-bipyridyl-4,4(')-dicarboxylic acid) ruthenium (II) dihydrate. The results indicated that the photocurrent and conversion efficiency of electrodes can be increased with the addition of the pre-deposited TiO(2) film and the adhesion treatment using DMF. Additionally, the dye loading, photocurrent, and efficiency of the electrodes were gradually increased by increasing the average thickness of the nanofibrous TiO(2) membranes. The efficiency of the fibrous TiO(2) photoelectrode with the average membrane thickness of 3.9 µm has a maximum value of 4.14%.