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ObjectiveTo evaluate the extent to which uterine fibroids are associated with antimüllerian hormone (AMH) concentrations.DesignCross-sectional study.SettingBaseline data from the Study of the Environment, Lifestyle, and Fibroids, which is a 5-year longitudinal study of African American women.Patient(s)A total of 1,643 women aged 23-35 years without a known history of fibroids.ExposureFibroid presence.Intervention(s)None.Main outcome measure(s)The primary outcome was percent difference in the mean AMH concentration between participants with fibroids and those without fibroids. The secondary outcomes were percent differences in the mean AMH concentrations in participants with different numbers, sizes, types, and positions of fibroids and the percent difference in the mean AMH concentration in participants with different uterine volumes.Result(s)At least 1 fibroid was identified on ultrasound in 362 (22%) participants. There was a small difference in the mean AMH concentrations in participants with fibroids (age-adjusted model: -4.6%, 95% confidence interval (CI): -14.5% to 6.5%; multivariable model: -4.6%, 95% CI: -14.4% to 6.3%). The mean AMH concentrations were found to decrease with increasing fibroid number. Although differences in AMH concentrations were not statistically significant, compared with no fibroids, the mean percent differences in AMH concentrations for 1, 2-3, and ≥4 fibroids were -1.2% (95% CI: -13.2% to 12.5%), -7.1% (95% CI: -23.3% to 12.5%), and -17.5% (95% CI: -38.2% to 10.0%), respectively. There were no consistent associations between AMH concentrations and fibroid location, size, or uterine volume.Conclusion(s)The presence of fibroids was not materially associated with AMH concentrations. Other than a monotonic inverse relationship between fibroid number and AMH concentrations, no other fibroid characteristics were consistently or appreciably associated, although associations were imprecise.

BackgroundThe urban-rural designation has been an important risk factor in infectious disease epidemiology. Many studies rely on a politically determined dichotomization of rural versus urban spaces, which fails to capture the complex mosaic of infrastructural, social and environmental factors driving risk. Such evaluation is especially important for Plasmodium transmission and malaria disease. To improve targeting of anti-malarial interventions, a continuous composite measure of urbanicity using spatially-referenced data was developed to evaluate household-level malaria risk from a house-to-house survey of children in Malawi.MethodsChildren from 7564 households from eight districts throughout Malawi were tested for presence of Plasmodium parasites through finger-prick blood sampling and slide microscopy. A survey questionnaire was administered and latitude and longitude coordinates were recorded for each household. Distances from households to features associated with high and low levels of development (health facilities, roads, rivers, lakes) and population density were used to produce a principal component analysis (PCA)-based composite measure for all centroid locations of a fine geo-spatial grid covering Malawi. Regression methods were used to test associations of the urbanicity measure against Plasmodium infection status and to predict parasitaemia risk for all locations in Malawi.ResultsInfection probability declined with increasing urbanicity. The new urbanicity metric was more predictive than either a governmentally defined rural/urban dichotomous variable or a population density variable. One reason for this was that 23% of cells within politically defined rural areas exhibited lower risk, more like those normally associated with "urban" locations.ConclusionsIn addition to increasing predictive power, the new continuous urbanicity metric provided a clearer mechanistic understanding than the dichotomous urban/rural designations. Such designations often ignore urban-like, low-risk pockets within traditionally rural areas, as were found in Malawi, along with rural-like, potentially high-risk environments within urban areas. This method of characterizing urbanicity can be applied to other infectious disease processes in rapidly urbanizing contexts.

There is increasing appreciation that latrine access does not imply use-many individuals who own latrines do not consistently use them. Little is known, however, about the determinants of latrine use, particularly among those with variable defecation behaviors. Using the integrated behavior model of water, sanitation, and hygiene framework, we sought to characterize determinants of latrine use in rural Ecuador. We interviewed 197 adults living in three communities with a survey consisting of 70 psychosocial defecation-related questions. Questions were excluded from analysis if responses lacked variability or at least 10% of respondents did not provide a definitive answer. All interviewed individuals had access to a privately owned or shared latrine. We then applied adaptive elastic nets (ENET) and supervised principal component analysis (SPCA) to a reduced dataset of 45 questions among 154 individuals with complete data to select determinants that predict self-reported latrine use. Latrine use was common, but not universal, in the sample (76%). The SPCA model identified six determinants and adaptive ENET selected five determinants. Three indicators were represented in both models-latrine users were more likely to report that their latrine is clean enough to use and also more likely to report daily latrine use; while those reporting that elderly men were not latrine users were less likely to use latrines themselves. Our findings suggest that social norms are important predictors of latrine use, whereas knowledge of the health benefits of sanitation may not be as important. These determinants are informative for promotion of latrine adoption.

OBJECTIVE:In a pilot study, our group showed that an internet-based self-management program improves self-efficacy in systemic sclerosis (SSc). The objective of the current study was to compare an internet-based self-management program to a patient-focused educational book developed to assess measures of self-efficacy and other patient-reported outcomes in patients with SSc. METHODS:We conducted a 16-week randomized, controlled trial. RESULTS:Of the 267 participants who completed baseline questionnaires and were randomized to the intervention (internet: www.selfmanagescleroderma.com) or control (book) group, 123 participants (93%) in the internet group and 124 participants (94%) in the control group completed the 16-week randomized controlled trial (RCT). The mean ± SD age of all participants was 53.7 ± 11.7 years, 91% were women, and 79.4% had some college or a higher degree. The mean ± SD disease duration after diagnosis of SSc was 8.97 ± 8.50 years. There were no statistical differences between the 2 groups for the primary outcome measure (Patient-Reported Outcomes Measurement Information System Self-Efficacy for Managing Symptoms: mean change of 0.35 in the internet group versus 0.94 in the control group; P = 0.47) and secondary outcome measures, except the EuroQol 5-domain instrument visual analog scale score (P = 0.05). Internet group participants agreed that the self-management modules were of importance to them, the information was presented clearly, and the website was easy to use and at an appropriate reading level. CONCLUSION:Our RCT showed that the internet-based self-management website was not statistically superior to an educational patient-focused book in improving self-efficacy and other measures. The participants were enthusiastic about the content and presentation of the self-management website.

ObjectiveTo determine the inter/intraobserver reliability of the tender and swollen joint counts (TJC, SJC) and the modified Rodnan Skin Score (mRSS) in diffuse cutaneous systemic sclerosis (dcSSc) and to assess content validity of the TJC/SJC.MethodsTen rheumatologists completed the SJC, TJC, and mRSS on 7 patients. Musculoskeletal ultrasound (MSUS) was performed.ResultsInterobserver and intraobserver reliability for the TJC was 0.97 and 0.99, for the SJC was 0.24 and 0.71, and for the mRSS was 0.81 and 0.94, respectively. MSUS abnormalities did not correspond with SJC/TJC.ConclusionWe demonstrate excellent inter- and intraobserver reliability for the mRSS and TJC in dcSSc. However, the SJC and TJC did not correspond to MSUS.

ObjectiveEarly diffuse cutaneous systemic sclerosis (dcSSc) is characterized by rapid changes in the skin and internal organs. The objective of this study was to develop a composite response index in dcSSc (CRISS) for use in randomized controlled trials (RCTs).MethodsWe developed 150 paper patient profiles with standardized clinical outcome elements (core set items) using patients with dcSSc. Forty scleroderma experts rated 20 patient profiles each and assessed whether each patient had improved or not improved over a period of 1 year. Using the profiles for which raters had reached a consensus on whether the patients were improved versus not improved (79% of the profiles examined), we fit logistic regression models in which the binary outcome referred to whether the patient was improved or not, and the changes in the core set items from baseline to followup were entered as covariates. We tested the final index in a previously completed RCT.ResultsSixteen of 31 core items were included in the patient profiles after a consensus meeting and review of test characteristics of patient-level data. In the logistic regression model in which the included core set items were change over 1 year in the modified Rodnan skin thickness score, the forced vital capacity, the patient and physician global assessments, and the Health Assessment Questionnaire disability index, sensitivity was 0.982 (95% confidence interval 0.982-0.983) and specificity was 0.931 (95% confidence interval 0.930-0.932), and the model with these 5 items had the highest face validity. Subjects with a significant worsening of renal or cardiopulmonary involvement were classified as not improved, regardless of improvements in other core items. With use of the index, the effect of methotrexate could be differentiated from the effect of placebo in a 1-year RCT (P = 0.02).ConclusionWe have developed a CRISS that is appropriate for use as an outcome assessment in RCTs of early dcSSc.

Built environment factors constrain individual level behaviors and choices, and thus are receiving increasing attention to assess their influence on health. Traditional regression methods have been widely used to examine associations between built environment measures and health outcomes, where a fixed, prespecified spatial scale (e.g., 1 mile buffer) is used to construct environment measures. However, the spatial scale for these associations remains largely unknown and misspecifying it introduces bias. We propose the use of distributed lag models (DLMs) to describe the association between built environment features and health as a function of distance from the locations of interest and circumvent a-priori selection of a spatial scale. Based on simulation studies, we demonstrate that traditional regression models produce associations biased away from the null when there is spatial correlation among the built environment features. Inference based on DLMs is robust under a range of scenarios of the built environment. We use this innovative application of DLMs to examine the association between the availability of convenience stores near California public schools, which may affect children's dietary choices both through direct access to junk food and exposure to advertisement, and children's body mass index z scores.

ObjectiveDyspnoea is a common, multifactorial source of functional impairment among patients with dcSSc. Our objective was to assess the reliability, construct validity and responsiveness to change of the Saint George's Respiratory Questionnaire (SGRQ) in patients with early dcSSc participating in a multicentre prospective study.MethodsAt enrolment and 1 year, patients completed the SGRQ (a multi-item instrument with four scales: symptoms, activity, impact and total), a visual analogue scale (VAS) for breathing and the HAQ Disability Index (HAQ-DI) and underwent 6 min walk distance and pulmonary function tests, physician and patient global health assessments and high-resolution CT (HRCT). We assessed internal consistency reliability using Cronbach's α. For validity we examined the ability of the SGRQ to differentiate the presence vs absence of interstitial lung disease (ILD) on HRCT or restrictive lung disease and evaluated the 1 year responsiveness to change using pulmonary function tests and patient- and physician-reported anchors. Correlation coefficients of 0.24-0.36 were considered moderate and >0.37 was considered large.ResultsA total of 177 patients were evaluated. Reliability was satisfactory for all SGRQ scales (0.70-0.93). All scales showed large correlations with the VAS for breathing and diffusing capacity of the lung for carbon monoxide in the overall cohort and in the subgroup with ILD. Three of the four scales in the overall cohort and the total scale in the ILD subgroup showed moderate to large correlation with the HAQ-DI and the predicted forced vital capacity (r = 0.33-0.44). Each scale discriminated between the presence and absence of ILD and restrictive lung disease (P ≤ 0.0001-0.03). At follow-up, all scales were responsive to change using different anchors.ConclusionThe SGRQ has acceptable reliability, construct validity and responsiveness to change for use in a dcSSc population and differentiates between patients with and without ILD.

ObjectiveSkin and musculoskeletal involvement are frequently present early in diffuse cutaneous systemic sclerosis (dcSSc). The current study examined the correlates for skin and musculoskeletal measures in a 1-year longitudinal observational study.MethodsPatients with dcSSc were recruited at 4 US centers and enrolled in a 1-year study. Prespecified and standardized measures included physician and patient assessments of skin involvement, modified Rodnan skin score (MRSS), durometer score, Health Assessment Questionnaire disability index, serum creatine phosphokinase, tender joint counts, and presence/absence of tendon friction rubs, small joint contractures, and large joint contractures. Additionally, physician and patient global health assessments and health-related quality of life assessments were recorded. Correlations were computed among the baseline global assessments, skin variables, and musculoskeletal variables. Using the followup physician and patient anchors, effect sizes were calculated.ResultsA total of 200 patients were studied: 75% were women, mean ± SD age was 50.0 ± 11.9 years, and mean ± SD disease duration from first non-Raynaud's phenomenon symptom was 1.6 ± 1.4 years. Physician global health assessment had large correlations with MRSS (r = 0.60) and physician-reported skin involvement visual analog scale in the last month (r = 0.74), whereas patient global assessment had large correlations with MRSS, the Short Form 36 health survey physical component scale, skin interference, and skin involvement in the last month (r = 0.37-0.72). Four of 9 skin variables had moderate to large effect sizes (0.51-1.09).ConclusionPhysician and patient global assessments have larger correlations with skin measures compared to musculoskeletal measures. From a clinical trial perspective, skin variables were more responsive to change than musculoskeletal variables over a 1-year period, although both provide complementary information.

ObjectiveTo evaluate routinely collected non-invasive tests from 2 systemic sclerosis (SSc) cohorts to determine their predictive value alone and in combination versus right heart catheterization (RHC)-confirmed pulmonary arterial hypertension (PAH).MethodsWe evaluated 2 cohorts of patients who were at risk or with incident PAH: (1) The Pulmonary Hypertension Assessment and Recognition Outcomes in Scleroderma (PHAROS) cohort and (2) an inception SSc cohort at Cochin Hospital, Paris, France. Estimated right ventricular systolic pressure (eRVSP) as determined by transthoracic echocardiogram (TTE) and pulmonary function test (PFT) measures was evaluated, and the predictive values determined. We then evaluated patients with PAH missed on TTE cutoffs that were subsequently identified by a PFT measure.ResultsIn the PHAROS cohort (n = 206), 59 (29%) had RHC-defined PAH. An eRVSP threshold of 35-50 mm Hg failed to diagnose PAH in 7% to 31% of patients, 50% to 70% of which (n = 2-13) were captured by PFT measures. In the Cochin cohort (n = 141), 10 (7%) patients had RHC confirmed PAH. An eRVSP threshold of 35-50 mm Hg missed 0% to 70% (n = 0-7) of patients, of which 0% to 68% (n = 0-6) were met by PFT measures. The combination of TTE and PFT improved the negative predictive value for diagnosing PAH.ConclusionIn 2 large SSc cohorts, screening with TTE and PFT captured a majority of patients with PAH. TTE and PFT complement each other for the diagnosis of PAH.