Surgical restabilization reduces the progression of post-traumatic osteoarthritis initiated by ACL rupture in mice.

OBJECTIVE: People who sustain joint injuries such as anterior cruciate ligament (ACL) rupture often develop post-traumatic osteoarthritis (PTOA). In human patients, ACL injuries are often treated with ACL reconstruction. However, it is still unclear how effective joint restabilization is for reducing the progression of PTOA. The goal of this study was to determine how surgical restabilization of a mouse knee joint following non-invasive ACL injury affects PTOA progression. DESIGN: In this study, 187 mice were subjected to non-invasive ACL injury or no injury. After injury, mice underwent restabilization surgery, sham surgery, or no surgery. Mice were then euthanized on day 14 or day 49 after injury/surgery. Functional analyses were performed at multiple time points to assess voluntary movement, gait, and pain. Knees were analyzed ex vivo with micro-computed tomography, RT-PCR, and whole-joint histology to assess articular cartilage degeneration, synovitis, and osteophyte formation. RESULTS: Both ACL injury and surgery resulted in loss of epiphyseal trabecular bone (-27-32%) and reduced voluntary movement at early time points. Joint restabilization successfully lowered OA score (-78% relative to injured at day 14, p < 0.0001), and synovitis scores (-37% relative to injured at day 14, p = 0.042), and diminished the formation of chondrophytes/osteophytes (-97% relative to injured at day 14, p < 0.001, -78% at day 49, p < 0.001). CONCLUSIONS: This study confirmed that surgical knee restabilization was effective at reducing articular cartilage degeneration and diminishing chondrophyte/osteophyte formation after ACL injury in mice, suggesting that these processes are largely driven by joint instability in this mouse model. However, restabilization was not able to mitigate the early inflammatory response and the loss of epiphyseal trabecular bone, indicating that these processes are independent of joint instability.

Reducing saturated fat intake lowers LDL-C but increases Lp(a) levels in African Americans: the GET-READI feeding trial.

Reducing dietary saturated fatty acids (SFA) intake results in a clinically significant lowering of low-density lipoprotein cholesterol (LDL-C) across ethnicities. In contrast, dietary SFA's role in modulating emerging cardiovascular risk factors in different ethnicities remains poorly understood. Elevated levels of lipoprotein(a) [Lp(a)], an independent cardiovascular risk factor, disproportionally affect individuals of African descent. Here, we assessed the responses in Lp(a) levels to dietary SFA reduction in 166 African Americans enrolled in GET-READI (The Gene-Environment Trial on Response in African Americans to Dietary Intervention), a randomized controlled feeding trial. Participants were fed two diets in random order for 5 weeks each: 1) an average American diet (AAD) (37% total fat: 16% SFA), and 2) a diet similar to the Dietary Approaches to Stop Hypertension (DASH) diet (25% total fat: 6% SFA). The participants' mean age was 35 years, 70% were women, the mean BMI was 28 kg/m2, and the mean LDL-C was 116 mg/dl. Compared to the AAD diet, LDL-C was reduced by the DASH-type diet (mean change: -12 mg/dl) as were total cholesterol (-16 mg/dl), HDL-C (-5 mg/dl), apoA-1 (-9 mg/dl) and apoB-100 (-5 mg/dl) (all P < 0.0001). In contrast, Lp(a) levels increased following the DASH-type diet compared with AAD (median: 58 vs. 44 mg/dl, P < 0.0001). In conclusion, in a large cohort of African Americans, reductions in SFA intake significantly increased Lp(a) levels while reducing LDL-C. Future studies are warranted to elucidate the mechanism(s) underlying the SFA reduction-induced increase in Lp(a) levels and its role in cardiovascular risk across populations.

Same-day testing with initiation of antiretroviral therapy or tuberculosis treatment versus standard care for persons presenting with tuberculosis symptoms at HIV diagnosis: A randomized open-label trial from Haiti.

BACKGROUND: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population. METHODS AND FINDINGS: We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov NCT03154320.

Perinatal Hospital Practices Are Associated with Breastfeeding through 5 Months Postpartum among Women and Infants from Low-Income Households.

BACKGROUND: Breastfeeding (BF) provides optimal nutrition during the first 6 mo of life and is associated with reduced infant mortality and several health benefits for children and mothers. However, not all infants in the United States are breastfed, and sociodemographic disparities exist in BF rates. Experiencing more BF-friendly maternity care practices at the hospital is associated with better BF outcomes, but limited research has examined this association among mothers enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), a population at risk of low BF rates. OBJECTIVES: We assessed the association between BF-related hospital practices (rooming-in, support from hospital staff, and provision of a pro-formula gift pack) and the odds of any or exclusive BF through 5 mo among infants and mothers enrolled in WIC. METHODS: We analyzed data from the WIC Infant and Toddler Feeding Practices Study II, a nationally representative cohort of children and caregivers enrolled in WIC. Exposures included maternal experience of hospital practices reported at 1 mo postpartum, and BF outcomes were surveyed at 1, 3, and 5 mo. ORs and 95% CIs were obtained using survey-weighted logistic regression, adjusting for covariates. RESULTS: Rooming-in and strong hospital staff support were associated with higher odds of any BF at 1, 3, and 5 mo postpartum. Provision of a pro-formula gift pack was negatively associated with any BF at all time points and with exclusive BF at 1 mo. Each additional BF-friendly hospital practice experienced was associated with 47% to 85% higher odds of any BF over the first 5 mo and 31% to 36% higher odds of exclusive BF over the first 3 mo. CONCLUSIONS: Exposure to BF-friendly hospital practices was associated with BF beyond the hospital stay. Expanding BF-friendly policies at the hospital could increase BF rates in the United States WIC-served population.

Evaluation of pharmacist guided intervention using procalcitonin and respiratory virus testing.

INTRODUCTION: Acute respiratory infections make up a sizable percentage of emergency department (ED) visits and many result in antibiotics being prescribed. Procalcitonin (PCT) has been found to reduce antibiotic use in both outpatient and critical care settings, yet remains underused in the ED. This study aimed to evaluate whether point of care molecular influenza and Respiratory Syncytial Virus (RSV) testing, PCT, and a pharmacist driven educational intervention in aggregate optimizes antibiotic and antiviral prescribing in the ED setting. METHODS: A randomized trial of the Cobas Liat Flu/RSV Assay, procalcitonin, and the use of pharmacist-led education in patients 0-50 years of age being seen in the ED for Influenza Like Illness (ILI) or acute respiratory illness. The study enrolled 200 ED patients between March 2018 and April 2022. RESULTS: There was little difference in antibiotic or antiviral prescribing between the intervention and control groups in this study (39%-32% = 7.0%, 95% CI: -6.2, 20.2, P = 0.30). However, a post-hoc analysis of the use of procalcitonin showed results were used as indicated in the ED (P = 0.001). CONCLUSION: PCT can be used in both adult and pediatric populations to help guide the decision of whether to treat with antibiotics in the ED setting. Pharmacist guided education may not be a driving factor.

Outcomes of random-start letrozole protocol with PGT-A in women with breast cancer undergoing fertility preservation.

PURPOSE  : To compare the cycle characteristics and outcomes of random-start-controlled ovarian stimulation (RSCOS) protocols to the outcomes of standard-start-controlled ovarian stimulation (SSCOS) cycles and to report the utility of PGT-A in these cycles. METHODS: One hundred and seventeen who underwent SSCOS and 39 who underwent RSCOS for oocyte and/or embryo cryopreservation before breast cancer chemotherapy were retrospectively evaluated. Mean number of embryos and blastocyst euploidy rates were the main outcome measures. RESULTS: A majority of RSCOS cycles were initiated in the luteal phase (66.6% luteal vs. 33.3% follicular). While the total dose of gonadotropins was significantly higher in the RSCOS (3720.8 ± 1230.0 vs. 2345.1 ± 803.6 IU; P < 0.001), the mean number of mature oocytes and embryos was similar to SSCOS. However, there was a trend for a higher number of mean embryos with luteal start RSCOS (6.9 ± 2.7 in late follicular start vs. 9.4 ± 4.2 in luteal start, P = 0.08). PGT-A was performed in 48% of the cases that underwent embryo cryopreservation in RSCOS (12 women, mean age = 35.3 ± 4.1; 87 blastocysts), revealing a euploidy rate of 36.2 ± 22.3% per patient. This rate was comparable to a 45% aneuploidy rate from similarly aged published data. Of the 7 RSCOS patients who returned for frozen embryo transfer, 5 delivered and one has an ongoing pregnancy, while in SSCOS, 18 out of 40 cycles resulted in live birth. CONCLUSION: Our data suggests that RSCOS fertility preservation cycle outcomes are similar to those with SSCOS and result in age-appropriate euploidy rates.

Effectiveness of a worksite lifestyle intervention to reduce BMI among farmworkers in California: a cluster randomised controlled trial.

OBJECTIVE: To evaluate the effectiveness of PASOS SALUDABLES, a culturally tailored lifestyle intervention to prevent obesity and diabetes among Latino farmworkers, when implemented at large scale in the worksite. DESIGN: This study was a two-arm parallel group, cluster randomised controlled trial, where participants received either a twelve-session lifestyle intervention (intervention) or six-session leadership training (control) at their worksite. The intervention was delivered by Promotoras in Spanish. All sessions were conducted at the worksites (ranches) during meal breaks. Blinded, trained research assistants collected socio-demographic and outcome data (i.e. BMI as primary outcome and waist circumference, glycated Hb (HbA1c), cholesterol and blood pressure as secondary outcomes) at baseline and follow-up assessments (i.e. 3 months, 6 months, 1 year and 1·5 years). SETTING: Recruitment and intervention delivery occurred at twelve study ranches in Oxnard, California. PARTICIPANTS: We enrolled farmworkers hired by a large berry grower company, who were ≥18 years old, spoke Spanish and were free of diabetes at screening. RESULTS: A total of 344 workers were enrolled in the intervention and 271 in the control group. The intervention resulted in attenuated increase of BMI over time; however, the difference in trend between groups was not significant (ß = -0·01 for slope difference, P = 0·29). No significantly different trend by group was observed in secondary outcomes (P > 0·27). CONCLUSIONS: The worksite intervention, implemented during meal breaks, did not reduce BMI or other clinical indicators. Nevertheless, this study supports the feasibility of recruiting and engaging the Latino farmworker population in workplace health promotion interventions.

Assessing local California trends in emergency physician opioid prescriptions from 2012 to 2020: Experiences in a large academic health system.

OBJECTIVES: There has been increased focus nationally on limiting opioid prescriptions. National data demonstrates a decrease in annual opioid prescriptions among emergency medicine physicians. We analyzed data from 2012 to 2020 from a large academic health system in California to understand trends in opioid prescribing patterns for emergency department (ED) discharged patients and assessed the potential impact of two initiatives at limiting local opioid prescriptions. METHODS: In 2012-2020, monthly ED visit data was used to evaluate the total number of outpatient opioid prescriptions and percent of ED visits with opioid prescriptions (as primary outcomes). Descriptive statistics, graphic representation, and segmented regression with interrupted times series were used based on two prespecified time points associated with intensive local initiatives directed at limiting opioid prescribing1) comprehensive emergency medicine resident education and 2) electronic health record (EHR)-based intervention. RESULTS: Between March 2012 and July 2020, a total of 41,491 ED discharged patients received an opioid prescription. The three most commonly prescribed drugs were hydrocodone (84.1%), oxycodone (10.8%), and codeine (2.8%). After implementing comprehensive emergency medicine resident education, the total number of opioid prescriptions, the percentage of opioid prescriptions over total ED visit numbers and the total tablet number showed decreasing trends (p's ≤ 0.01), in addition to the natural (pre-intervention) decreasing trends. In contrast, later interventions in the EHR tended to show attenuated decreasing trends. CONCLUSIONS: From 2012 to 2020, we found that total opioid prescriptions decreased significantly for discharged ED patients. This trend is seen nationally. However, our specific interventions further heightened this downward trend. Evidence-based legislation, policy changes, and educational initiatives that impact prescribing practices should guide future efforts.

Impact of adjuvant chemotherapy or tamoxifen-alone on the ovarian reserve of young women with breast cancer.

PURPOSE: To determine the longitudinal impact of adjuvant chemotherapy and tamoxifen-only treatments on the reproductive potential of women with breast cancer by using a sensitive ovarian reserve marker anti-Mullerian hormone (AMH) as a surrogate. METHODS: One-hundred-and-forty-two women with a primary diagnosis of breast cancer were prospectively followed with serum AMH assessments before the initiation, and 12, 18 and 24 months after the completion of adjuvant chemotherapy or the start of tamoxifen-only treatment. The chemotherapy regimens were classified into Anthracycline-Cyclophosphamide-based (AC-based) and Cyclophosphamide-Methotrexate + 5-Fluorouracil (CMF). Longitudinal data were analyzed by mixed effects model for treatment effects over time, adjusting for baseline age and BMI. RESULTS: Both chemotherapy regimens resulted in significant decline in ovarian reserve compared to the tamoxifen-only treatment (p < 0.0001 either regimen vs. tamoxifen for overall trend). AMH levels sharply declined at 12 months but did not show a significant recovery from 12 to 18 and 18 to 24 months after the completion of AC-based or CMF regimens. The degree of decline did not differ between the two chemotherapy groups (p = 0.53). In contrast, tamoxifen-only treatment did not significantly alter the age-adjusted serum AMH levels over the 24-month follow up. Likewise, the use of adjuvant tamoxifen following AC-based regimens did not affect AMH recovery. CONCLUSIONS: Both AC-based regimens and CMF significantly compromise ovarian reserve, without a recovery beyond 12 months post-chemotherapy. In contrast, tamoxifen-only treatment does not seem to alter ovarian reserve. These data indicate that the commonly used chemotherapy regimens but not the hormonal therapy compromise future reproductive potential.

Blinding, sham, and treatment effects in randomized controlled trials for back pain in 2000-2019: A review and meta-analytic approach.

BACKGROUND: Blinding aims to minimize biases from what participants and investigators know or believe. Randomized controlled trials, despite being the gold standard to evaluate treatment effect, do not generally assess the success of blinding. We investigated the extent of blinding in back pain trials and the associations between participant guesses and treatment effects. METHODS: We did a review with PubMed/OvidMedline, 2000-2019. Eligibility criteria were back pain trials with data available on treatment effect and participants' guess of treatment. For blinding, blinding index was used as chance-corrected measure of excessive correct guess (0 for random guess). For treatment effects, within- or between-arm effect sizes were used. Analyses of investigators' guess/blinding or by treatment modality were performed exploratorily. RESULTS: Forty trials (3899 participants) were included. Active and sham treatment groups had mean blinding index of 0.26 (95% confidence interval: 0.12, 0.41) and 0.01 (-0.11, 0.14), respectively, meaning 26% of participants in active treatment believed they received active treatment, whereas only 1% in sham believed they received sham treatment, beyond chance, that is, random guess. A greater belief of receiving active treatment was associated with a larger within-arm effect size in both arms, and ideal blinding (namely, "random guess," and "wishful thinking" that signifies both groups believing they received active treatment) showed smaller effect sizes, with correlation of effect size and summary blinding indexes of 0.35 (p = 0.028) for between-arm comparison. We observed uniformly large sham treatment effects for all modalities, and larger correlation for investigator's (un)blinding, 0.53 (p = 0.046). CONCLUSION: Participants in active treatments in back pain trials guessed treatment identity more correctly, while those in sham treatments tended to display successful blinding. Excessive correct guesses (that could reflect weaker blinding and/or noticeable effects) by participants and investigators demonstrated larger effect sizes. Blinding and sham treatment effects on back pain need due consideration in individual trials and meta-analyses.

Exploring the implications of the new ICD-10-CM classification system for injury surveillance: analysis of dually coded data from two medical centres.

INTRODUCTION: External cause of injury matrices is used to classify mechanisms/causes of injuries for surveillance and research. Little is known about the performance of the Centers for Disease Control and Prevention's new external cause of injury matrix for Clinical Modification of the 10th Revision of the International Classification of Diseases (ICD-10-CM), compared with the ICD-9-CM version. METHODS: Dually coded (ICD-9-CM and ICD-10-CM) administrative data were obtained from two major academic trauma centres. Injury-related cases were identified and categorised by mechanism/cause and manner/intent. Comparability ratios (CR) were used to estimate the net impact of changing from ICD-9-CM to ICD-10-CM on the number of cases classified to each mechanism/cause category. Chamberlain's percent positive agreements (PPA) were calculated and McNemar's test was used to assess the significance of observed classification differences. RESULTS: Of 4832 and 5211 dual-coded records from the two centres, 632 and 520 with injury-related principal diagnoses and external cause codes in both ICD-9-CM and ICD-10-CM were identified. CRs for the mechanisms/causes with at least 20 records ranged from 0.85 to 1.9 at one centre and from 0.97 to 1.07 at the other. Among these mechanisms/causes, PPAs ranged from 33% for 'other transport' to 94% for poisoning at one centre, and from 75% for 'other transport' to 100% for fires/burns at the other centre. Case assignment differed significantly for falls, motor vehicle traffic, other transport, and 'struck by/against' injuries at one centre, and for 'other pedal cyclist' at the other centre. CONCLUSION: Switching to ICD-10-CM and the new external cause of injury matrix may affect injury surveillance and research, especially for certain mechanisms/causes.

Risk for Coccidioidomycosis among Hispanic Farm Workers, California, USA, 2018.

To determine occupational risk factors for coccidioidomycosis among adult Hispanic outdoor agricultural workers in California, USA, we conducted a case-control study of workers seen at the Kern County medical facility and referred to the public health laboratory for coccidioidomycosis serologic testing. Participants completed an interviewer-administered health and work questionnaire. Among 203 participants (110 case-patients with positive and 93 controls with negative serologic results), approximately half were women, and more than three quarters were born in Mexico. Associated with coccidioidomycosis were self-reported dust exposure and work with root and bulb vegetable crops. A protective factor was leaf removal, an activity associated with grape cultivation. We conclude that subjective dust exposure and work with root and bulb vegetable crops are associated with increased risk for coccidioidomycosis among Hispanic farm workers. The agricultural industry should evaluate and promote dust-reduction measures, including wetting soil and freshly harvested products.

Catastrophic costs of tuberculosis care in a population with internal migrants in China.

BACKGROUND: The internal rural-to-urban migration is one of the major challenges for tuberculosis (TB) control in China. Patient costs incurred during TB diagnosis and treatment could cause access and adherence barriers, particularly among migrants. Here, we estimated the prevalence of catastrophic costs of TB patients and its associated factors in an urban population with internal migrants in China. METHODS: A cross-sectional survey was conducted to enroll culture-confirmed pulmonary TB patients in Songjiang district, Shanghai, between December 1, 2014, and December 31, 2015. Consenting participants completed a questionnaire, which collected direct and indirect costs before and after the diagnosis of TB. The catastrophic cost was defined as the annual expenses of TB care that exceeds 20% of total household disposable income. We used logistic regression to identify factors associated with catastrophic costs. RESULTS: Overall, 248 drug-susceptible TB patients were enrolled, 70% (174/248) of them were from migrants. Migrant patients were significantly younger compared to resident patients. The total costs were 25,824 ($3689) and 13,816 ($1974) Chinese Yuan (RMB) in average for resident and migrant patients, respectively. The direct medical cost comprised about 70% of the total costs among both migrant and resident patients. Overall, 55% (132 of 248) of patients experienced high expenses (>10% of total household income), and 22% (55 of 248) experienced defined catastrophic costs. The reimbursement for TB care only reduced the prevalence of catastrophic costs to 20% (49 of 248). Meanwhile, 52% (90 of 174) of the internal migrants had no available local health insurance. Hospitalizations, no available insurance, and older age (> 45-year-old) contributed significantly to the occurrence of catastrophic costs. CONCLUSIONS: The catastrophic cost of TB service cannot be overlooked, despite the free policy. Migrants have difficulties benefiting from health insurance in urban cities. Interventions, including expanded medical financial assistance, are needed to secure universal TB care.

Effect of continued metabolic acidification into the first 3 days of lactation on blood calcium status in postpartum dairy cattle: A randomized controlled trial.

Although incidence of clinical hypocalcemia in postpartum dairy cows is low in US dairies, subclinical hypocalcemia after calving is common and has been associated with metabolic and infectious disease. It is widespread farm practice to feed a diet rich in anions to prepartum dairy cattle to support calcium homeostasis. However, this diet is typically discontinued at parturition, when calcium needs are still high. The objective of this trial was to determine the effects of extending metabolic acidification into the first 3 d of lactation in multiparous Holstein cows with the use of magnesium chloride (MgCl2) hexahydrate drenches on blood ionized calcium concentrations. Adult Holstein cows at a commercial dairy in their second or higher lactation, with a urine pH of 6.8 or less on the day of calving, were randomly assigned to either treatment or control groups, resulting in 13 cows in the treatment group and 14 cows in the control group. Treatment cows received 480 g of oral MgCl2 hexahydrate once daily for 3 d for continued acidification starting on the day of calving, whereas cows in the control group received no treatment. Urine pH was measured daily for 5 d, starting on the day of calving (0 DIM), to assess acidification status; blood was collected on day of calving (0 DIM), 2 DIM, and 4 DIM and analyzed for ionized calcium concentrations. Differences in blood ionized calcium and urine pH over time were compared using longitudinal data analysis. Urine pH was lower in treatment cows compared with control cows at 1, 2, and 3 DIM. Blood ionized calcium concentrations were different from baseline, taken at enrollment (0 DIM) and at 2 and 4 DIM in both treatment and control cows. However, no difference was detectable between treatment and control cows at 2 or 4 DIM with respect to blood ionized calcium concentrations. Oral supplementation with MgCl2 hexahydrate resulted in the desired acidification of urine pH in the treatment group, similar to feeding of an anionic close-up diet. Continued acidification of dairy cows until 2 DIM did not result in clinically meaningful higher blood calcium concentrations compared with controls, and further research is needed, to identify physiological reasons for this finding.

Repurposing Clinical Decision Support System Data to Measure Dosing Errors and Clinician-Level Quality of Care.

We aimed to develop and validate an instrument to detect hospital medication prescribing errors using repurposed clinical decision support system data. Despite significant efforts to eliminate medication prescribing errors, these events remain common in hospitals. Data from clinical decision support systems have not been used to identify prescribing errors as an instrument for physician-level performance. We evaluated medication order alerts generated by a knowledge-based electronic prescribing system occurring in one large academic medical center's acute care facilities for patient encounters between 2009 and 2012. We developed and validated an instrument to detect medication prescribing errors through a clinical expert panel consensus process to assess physician quality of care. Six medication prescribing alert categories were evaluated for inclusion, one of which - dose - was included in the algorithm to detect prescribing errors. The instrument was 93% sensitive (recall), 51% specific, 40% precise, 62% accurate, with an F1 score of 55%, positive predictive value of 96%, and a negative predictive value of 32%. Using repurposed electronic prescribing system data, dose alert overrides can be used to systematically detect medication prescribing errors occurring in an inpatient setting with high sensitivity.

The FANMI ("my FAMILY" in Creole) study to evaluate community-based cohort care for adolescent and young women living with HIV in Haiti: protocol for a randomized controlled trial.

BACKGROUND: Adolescent girls and young women living with HIV in resource-limited settings have the poorest health outcomes of any age group, due in part to poor retention in care. Differentiated models of HIV care that target the specific challenges of young people living with HIV are urgently needed. METHODS: The FANMI study is an unblinded randomized controlled trial designed to evaluate the efficacy of an adolescent-specific model of HIV care in Port-au-Prince, Haiti. The FANMI intervention places newly young women living with HIV who are not currently on ART or on ART ≤ 3 months, in cohorts of 5-10 peers to receive monthly group HIV care in a community location. In contrast, participants in the standard care arm receive routine HIV care and individual counseling each month in GHESKIO's Adolescent Clinic. A total of 160 participants ages 16-23 years old are being randomized on a 1:1 basis. The primary outcome is retention in HIV care defined as being alive and in care at 12 months after enrollment. Secondary outcomes include viral suppression at 12 months, sexual risk behaviors, acceptability of the FANMI intervention, and health care utilization and costs. DISCUSSION: The FANMI study evaluates a novel community-based cohort model of HIV care aimed at improving retention in care and reducing risk behaviors for HIV transmission among adolescent girls and young women living with HIV. Specifically, the FANMI model of care addresses social isolation by placing participants in cohorts of 5-10 peers to provide intensified peer support and makes HIV health management a group norm; reduces stigma and improves convenience by providing care in a community setting; and integrates clinical care and social support by the same providers to streamline care and promote long-term patient-provider relationships. If shown to be effective, the FANMI intervention may serve as a model of HIV care for improving retention among hard-to-reach adolescents and young adults in Haiti and could be adapted for other high-risk groups globally. TRIAL REGISTRATION: Identifier: NCT03286504, Registered September 18, 2017.

Angioplasty vs stent in the treatment of transplant renal artery stenosis.

OBJECTIVE: To compare outcomes between percutaneous transluminal angioplasty and stent placement in the treatment of transplant renal artery stenosis (TRAS). METHODS: We retrospectively studied patients who underwent angiography for TRAS between 1/1/2008 and 9/20/2016 at 1 center. We compared the rates of restenosis in patients who were treated with angioplasty alone vs those who were treated with stenting. Secondary outcomes included serum creatinine and blood pressure after intervention and graft and patient survival. RESULTS: A total of 82 patients were identified as having TRAS after angiography. Restenosis occurred in 28% (16 of 58) of the angioplasty patients compared with 8% (2 of 24) of the stented patients (P = .04). Repeat angiography occurred in 14% (8 of 58) of angioplasty patients vs 13% (3 of 24) of stented patients (P = .9). The stented group had significantly higher pre-intervention stenosis (71% vs 64%, P = .01) and lower postintervention stenosis (4% vs 30%, P < .001). Serum creatinine and blood pressures were not significantly different between the 2 groups at 30, 90, or 360 days postintervention. There was no statistically significant difference in graft or patient survival between groups (P = .37). CONCLUSIONS: Stent placement resulted in fewer cases of restenosis compared with angioplasty alone, although no benefit in terms of serum creatinine, blood pressure, or patient and graft survival was shown.

Sample size calculations for blinding assessment.

Blinding is a critical component in randomized clinical trials along with treatment effect estimation and comparisons between the treatments. Various methods have been proposed for the statistical analyses of blinding-related data, but there is little guidance for determining the sample size for this type of data, especially if blinding assessment is done in pilot studies. In this paper, we try to fill this gap and provide simple methods to address sample size calculations for a "new" study with different research questions and scenarios. The proposed methods are framed in terms of estimation/precision or statistical testing to allow investigators to choose the best suited method for their goals. We illustrate the methods using worked examples with real data.

Protocol for a cluster randomized controlled trial to study the effectiveness of an obesity and diabetes intervention (PASOS) in an immigrant farmworker population.

BACKGROUND: Studies have shown that the prevalence of overweight, obesity and diabetes are higher in the largely Hispanic, immigrant farmworker population in California. Though to date, few interventional studies have focused on these issues in this at-risk population. The objective of this paper is to describe the study design of a cluster randomized controlled trial aimed at evaluating the effectiveness of an obesity and diabetes work place intervention in an immigrant farm worker population. METHODS: PASOS is an obesity and diabetes intervention program that will be implemented on ranches where immigrant farmworkers spend a considerable amount of time each day. This cluster randomized controlled study will enroll approximately 600 farmworkers. Using a uniform distribution for random number generation, ranches are randomized using a 1:1 ratio as either control or intervention. Baseline data will be taken from eligible participants and analyzed against data collected at the post-intervention, 6-month, 1-year, and 1.5-year follow-ups. The enrollment period is 1.5 years. DISCUSSION: Few studies have been conducted that aim to evaluate the effectiveness of a worksite intervention for obesity and diabetes prevention in a largely Hispanic, farmworker population. This study has been tailored to this population in order to enhance the feasibility of implementation and retention. If successful in reducing obesity and increasing healthy lifestyle choices to reduce diabetes, this study design can be implemented on a larger scale. TRIAL REGISTRATION: NCT02480244 . Registered 24 June 2015.

Regional and Temporal Variations in Comorbidity Among US Dialysis Patients: A Longitudinal Study of Medicare Claims Data.

Medicare claims data are commonly used to query comorbidities for case-mix adjustment in research of patients with end-stage renal disease (ESRD) in the United States. These adjustments may affect reimbursement and quality rating through comparative profiling and ranking of dialysis facilities. We studied regional and temporal variations in comorbidity from claims data in the United States Renal Data System. Patients with a previous 1-year Medicare history who initiated dialysis therapy between 2006 and 2009 were examined with a follow-up period until 2012. By linking pre- and post-ESRD Medicare claims with the Dartmouth Atlas, we carried out a longitudinal data analysis with multivariable adjustment to investigate regional and temporal variations in the Liu comorbidity index. We identified 23 336 incident hemodialysis patients who were covered by Medicare the year prior to dialysis initiation and had survived with complete 3 years of follow-up data. With the United States divided into 4 geographic regions, the Western region was found to have the lowest Liu index over all 3 follow-up years, compared with the respective years in the other regions (Midwest, Northeast, and South). In comparison with the first year, the Liu index dropped significantly during the second and third years of follow-up across all 4 regions. Significant regional and temporal variations observed in the comorbidity index cannot be explained by differences in reimbursement (average per state) or predialysis comorbidity. Based on our exploratory study, future studies should focus on identifying the factors and reasons for these variations which have the potential to affect health care policy and research.