A non-randomized controlled stepped wedge trial to evaluate the effectiveness of a multi-level mammography intervention in improving appointment adherence in underserved women.

BACKGROUND: Considerable racial and socio-economic disparities exist in breast cancer. In spite of the existence of numerous evidence-based interventions (EBIs) aimed at reducing breast cancer screening barriers among the underserved, there is a lack of uptake or sub-optimal uptake of EBIs in community and clinical settings. This study evaluates a theoretically based, systematically designed implementation strategy to support adoption and implementation of a patient navigation-based intervention, called Peace of Mind Program (PMP), aimed at improving breast cancer screening among underserved women. METHODS/DESIGN: The PMP will be offered to federally qualified health centers and charity clinics in the Greater Houston area using a non-randomized stepped wedge design. Due to practical constraints of implementing and adopting in the real-world, randomization of start times and blinding will not be used. Any potential confounding or bias will be controlled in the analysis. Outcomes such as appointment adherence, patient referral to diagnostics, time to diagnostic referral, patient referral to treatment, time to treatment referral, and budget impact of the intervention will be assessed. Assessment of constructs from the consolidated framework for implementation research (CFIR) will be assessed during implementation and at the end of the study (sustainment) from each participating clinic. Data will be analyzed using descriptive statistics (chi-square tests) and generalized estimating equations (GEE). DISCUSSION: While parallel group randomized controlled trials (RCT) are considered the gold standard for evaluating EBI efficacy, withholding an effective EBI in practice can be both unethical and/or impractical. The stepped wedge design addresses this issue by enabling all clinics to eventually receive the EBI during the study and allowing each clinic to serve as its own control, while maintaining strong internal validity. We expect that the PMP will prove to be a feasible and successful strategy for reducing appointment no-shows in underserved women. CLINICAL TRIALS REGISTRATION NUMBER: NCT02296177.

Hiperparatireoidismo em gatos com hipertireoidismo experimental / Hyperparathyroidism in cats with experimental hyperthyroidism

Os efeitos do hipertireoidismo experimental, 150µg/kg/dia/42 dias de levotiroxina sódica, na homeostase do cálcio foram estudados em 14 gatos sem raça definida, com idades entre um e três anos. A cada 14 dias foram colhidas amostras de soro para a determinação da concentração da tiroxina total (T4), tiroxina livre (FT4), paratormônio intacto (PTH), cálcio total e ionizado, fósforo e, além disso, realizaram-se radiografias para a determinação da densidade mineral óssea (DMO). Observou-se aumento das concentrações séricas do PTH a partir do momento inicial (M0), com diferença significativa deste em relação às concentrações obtidas aos 14 (M1), 28 (M2) e 42 (M3) dias. Não houve diferença significativa nas concentrações séricas de cálcio total e fósforo entre todos os momentos. O cálcio ionizado diminui de M0 para M1 e de M1 para M3, com diferença significativa. Os hormônios tireoidianos apresentaram correlação positiva com o PTH e negativa com o cálcio ionizado. A correlação entre DMO e PTH a partir de M2 foi negativa e entre DMO e fósforo foi negativa somente em M2. Não se observou correlação entre DMO e as demais variáveis. Em M1, M2 e M3 foi observada correlação negativa entre o PTH e o cálcio ionizado. Conclui-se que o hipertireoidismo em gatos adultos jovens está associado ao hiperparatireoidismo secundário devido ao aumento do PTH e diminuição do cálcio ionizado. Os efeitos combinados dos hormônios tireoidianos e do PTH contribuíram para a diminuição da DMO.

The effect of experimental hyperthyroidism, 150µg/kg/day/42 days, on calcium homeostasis was studied in 14 mongrel cats aging from one to three-year-old. Total thyroxine (T4), free thyroxine (FT4), parathyroid hormone (PTH), total and ionized calcium, phosphorus, bone mineral density were measured. Serum concentrations of PTH of increased from the initial moment (MO), with significant differences to when measured after 14(M1), 28(M2), and 42(M3) days. However, significant differences on serum concentrations were not observed among the values of M1, M2, and M3. The ionized calcium significantly decreased from M0 to M1 and from M1 to M3. Thyroid hormones showed positive correlation with PTH and negative with ionized calcium. Bone mineral density showed negative correlation with PTH from M2 to M3 and with phosphorus on M2, with no correlation with the other variables. Negative correlation of PTH with ionized calcium was observed on M1, M2, and M3. In conclusion, hyperthyroidism in young adult cats is associated to secondary hyperparathyroidism due to increase of PTH and decrease of ionized calcium. The combined effects of thyroid hormones and PTH contributed to the reduction of bone mineral density.

Evaluation of varicella-zoster immune globulin: protection of immunosuppressed children after household exposure to varicella.

Varicella-zoster immune globulin (VZIG), an immunoglobulin prepared from normal donor plasma selected for high titer of antibody to varicella-zoster virus (VZV), and zoster immune globulin (ZIG), prepared from the plasma of donors convalescing from herpes zoster, were compared in a double-blind, randomized clinical trial to determine their relative efficacy in protecting immunosuppressed children from severe varicella. VZV infection occurred in 49 (60.4%) of 81 recipients of VZIG and in 57 (68.6%) of 83 recipients of ZIG. These rates and the clinical severity of varicella were not significantly different; however, the subclinical infection rate was significantly higher in ZIG recipients (31.3% vs. 16.0%). This difference was accounted for by a subgroup of patients receiving immunosuppressive therapy for nonneoplastic diseases. Doubling the dose of VZIG administered reduced the rate of subclinical infection. These data indicate that VZIG can be used to protect immunosuppressed children from severe chicken pox.

Infection of human peripheral blood mononuclear cells by varicella-zoster virus.

The infection of human peripheral blood leukocytes by varicella-zoster virus (VZV) was studied using an infectious center assay, indirect immunofluorescence and electron microscopy. Subsets of freshly isolated leukocytes were prepared, including granulocytes, mononuclear cells from Ficoll-Hypaque gradients, lymphocytes, and glass-adherent monocytes. When each of these populations was inoculated with VZV (MOI = 0.1), there was no evidence of effective infection. However, when monocytes were cultured in vitro for 7 days, they differentiated into macrophages that were productively infected with VZV. Peak percentages of infectious macrophages were detected 8-24 h after inoculation (mean 17.5%; range 10.2-30.4%). Using indirect immunofluorescence, viral antigens were detected in the cytoplasm and at the nuclear membranes of infected macrophages between 24 and 72 h after infection. Electron microscopy demonstrated the appearance of viral particles in the nucleus by 24 h. Large numbers of virions, often collected in tubules or vacuoles, were present in the cytoplasm at 48 h. The difference between the infection of fresh monocytes and cultured macrophages by VZV might reflect differences in their metabolic or differentiation state. The possible significance of these observations to VZV infection of immunocompromised hosts is discussed.