Jodi Lapidus

The Human Immunodeficiency Virus (HIV) epidemic is a serious yet under-addressed health concern for Native American communities across Indian Country (a reclaimed governmental reference for the con...

Research studies involving human subjects require collection of and reporting on demographic data related to race and ethnicity. However, existing practices lack standardized guidelines, leading to misrepresentation and biased inferences and conclusions for underrepresented populations in research studies. For instance, sometimes there is a misconception that self-reported racial or ethnic identity may be treated as a biological variable with underlying genetic implications, overlooking its role as a social construct reflecting lived experiences of specific populations. In this manuscript, we use the We All Count data equity framework, which organizes data projects across seven stages: Funding, Motivation, Project Design, Data Collection, Analysis, Reporting, and Communication. Focusing on data collection and analysis, we use examples – both real and hypothetical – to review common practice and provide critiques and alternative recommendations. Through these examples and recommendations, we hope to provide the reader with some ideas and a starting point as they consider embedding a lens of justice, equity, diversity, and inclusivity from research conception to dissemination of findings.

Background/aims To examine demographic and clinical factors associated with ocular pain 1 day after refractive surgery. Methods Prospective study of individuals undergoing refractive surgery. Participants rated their ocular pain on a 0–10 numerical rating scale (NRS) presurgery and 1 day after surgery. Presurgery, participants completed questionnaires on demographics, comorbidities, medications and dry eye and ocular pain symptoms; and an anaesthetised Schirmer test was performed. Acute ocular pain 1 day after surgery was defined as an NRS score of worst pain since surgery ≥3 and this group was compared with individuals with NRS scoresResults 251 individuals underwent refractive surgery (89% laser-assisted in situ keratomileusis, n=222; 11% PRK, n=29). Mean age was 35±8 years (range 19 to 60); 60% (n=150) self-identified as female, 80% (n=203) as White, and 36% (n=89) as Hispanic. Thirteen (5%) individuals reported ocular pain (NRS ≥3) prior to surgery and 67% (n=168) reported ocular pain 1 day after surgery (nine individuals had pain at both time points). Factors that were associated with pain 1 day after surgery included Hispanic ethnicity (adjusted relative risk (aRR) 1.42, 95% CI 1.21 to 1.68, pConclusion A majority of individuals report moderate or greater pain within 24 hours of refractive surgery. Hispanic ethnicity and eye pain prior to surgery were associated with self-reported acute postsurgical pain.

Objective measures of balance and gait have the potential to improve prediction of future fallers because balance and gait impairments are common precursors. We used the Instrumented Stand and Walk Test (ISAW) with wearable, inertial sensors to maximize the domains of balance and gait evaluated in a short test. We hypothesized that ISAW objective measures across a variety of gait and balance domains would improve fall prediction beyond history of falls and better than gait speed or dual-task cost on gait-speed. We recruited 214 high-functioning older men (mean 82 years), of whom 91 participants (42.5%) had one or more falls in the 12 months following the ISAW test. The ISAW test involved 30 s of stance followed by a 7-m walk, turn, and return. We examined regression models for falling using 17 ISAW metrics, with and without age and fall history, and characterize top-performing models by AUC and metrics included. The ISAW test improved distinguishing between future fallers and non-fallers compared to age and history of falls, alone (AUC improved from 0.69 to 0.75). Models with 1 ISAW metric usually included a postural sway measure, models with 2 ISAW measures included a turning measure, models with 3 ISAW measures included a gait variability measure, and models with 4 or 5 measures added a gait initiation measure. Gait speed and dual-task cost did not distinguish between fallers and non-fallers in this high-functioning cohort. The best fall-prediction models support the notion that older people may fall due to a variety of balance and gait impairments.

The gut microbiome has important effects on human health, yet its importance in human aging remains unclear. Using two independent cohorts comprising 4582 individuals across the adult lifespan we demonstrate that, starting in mid-to-late adulthood, gut microbiomes become increasingly unique with age. This uniqueness pattern is strongly associated with gut microbial amino acid derivatives circulating within the bloodstream, many of which have been previously identified as longevity biomarkers. At the latest stages of human life, two distinct patterns emerge wherein individuals in good health show continued microbial drift toward a unique compositional state, while the same drift is absent in individuals who perform worse on a number of validated health measures. The identified healthy aging pattern is characterized by an overall depletion of core genera found across most humans - primarily a depletion in the nearly ubiquitous genus Bacteroides . Consistently, retaining a high Bacteroides dominance into extreme age, or, equivalently, having a low gut microbiome uniqueness score, predicts decreased survival in a four-year follow-up. Our comprehensive analysis identifies the gut microbiome as a novel component of healthy aging, with important implications for the world’s growing older population.

: Measurement of serum testosterone (T) levels is recommended in the evaluation of osteoporosis in older men and estradiol (E2) and sex hormone binding globulin (SHBG) levels are associated with the rate of bone loss and fractures, but the clinical utility of sex steroid and SHBG measurements for the evaluation of osteoporosis in men has not been examined. To evaluate whether measurements of T, E2, and/or SHBG are useful for the prediction of fracture risk or the rate of bone loss in older men, we analyzed longitudinal data from 5487 community-based men participating in the Osteoporotic Fractures in Men (MrOS) study in the United States, Sweden, and Hong Kong. Serum T, E2, and SHBG levels were assessed at baseline; incident fractures were self-reported at 4-month intervals with radiographic verification (US), or ascertained via national health records (Sweden, Hong Kong). Rate of bone loss was assessed by serial measures of hip bone mineral density (BMD). We used receiver operating characteristic (ROC) curves, net reclassification improvement (NRI), and integrated discrimination improvement (IDI) to assess improvement in prediction. Mean age at baseline was 72 to 75 years and the prevalence of low T levels (<300 ng/dL) was 7.6% to 21.3% in the three cohorts. There were 619 incident major osteoporotic and 266 hip fractures during follow-up of approximately 10 years. Based on ROC curves, there were no improvements in fracture risk discrimination for any biochemical measure when added to models, including the Fracture Risk Assessment Tool (FRAX) with BMD. Although minor improvements in NRI were observed for the dichotomous parameters low bioavailable E2 (BioE2) (59.1 nM), neither sex steroids nor SHBG provided clinically useful improvement in fracture risk discrimination. Similarly, they did not contribute to the prediction of BMD change. In conclusion, there is limited clinical utility of serum E2, T, and SHBG measures for the evaluation of osteoporosis risk in elderly men. © 2016 American Society for Bone and Mineral Research.

Impaired mobility and falls are clinically important complications of Parkinson’s disease (PD) and a major detractor from quality of life for which there are limited therapies. Pathological, neuroimaging and clinical evidence suggest that degeneration of cholinergic systems may contribute to impairments of balance and gait in PD. The proposed trial will examine the effects of augmentation of the cholinergic system on balance and gait. The study is a single-site, proof of concept, randomized, double-blind, cross-over trial in patients with PD. Each treatment period will be 6 weeks with a 6-week washout between treatments for a total of 18 weeks for each subject. Donepezil in 2.5 mg capsules or identical appearing placebo capsules will be increased from two per day (5 mg) to four capsules (10 mg) after 3 weeks, if tolerated. Subjects will have idiopathic Parkinson’s disease, Hoehn and Yahr stages 2 to 4. We anticipate recruiting up to 100 subjects for screening to have 54 enrolled and 44 subjects complete both phases of treatment. Dropouts will be replaced. As this is a crossover trial, all subjects will be exposed to both donepezil and to placebo. The primary outcome measures will be the root mean square of the mediolateral sway when standing and the variability of the stride duration when walking for two minutes. Secondary outcomes will be the computerized Attention Network Test to examine three domains of attention and the Short-latency Afferent Inhibition (SAI), a physiological marker obtained with transcranial magnetic stimulation as a putative marker of cholinergic activity. The results of this study will be the most direct test of the hypothesized role of cholinergic neurotransmission in gait and balance. The study is exploratory because we do not know whether donepezil will affect gait, balance or attention, nor which measures of gait, balance or attention will be sensitive to drug manipulation. We hypothesize that change in cholinergic activity, as measured with SAI, will predict the relative effectiveness of donepezil on gait and balance. Our immediate goal is to determine the potential utility of cholinergic manipulation as a strategy for preventing or treating balance and gait dysfunction in PD. The findings of this trial are intended to lead to more sharply focused questions about the role of cholinergic neurotransmission in balance and gait and eventually to Phase II B trials to determine clinical utility of cholinergic manipulation to prevent falls and improve mobility. This trial is registered at clinical trials.gov ( NCT02206620 ).

We systematically characterized maternal serum proteome in women with clinical preeclampsia (PE) and asymptomatic women in early pregnancy that subsequently developed PE. Clinical PE cohort comprised 30 patients with mild PE, 30 with severe PE, and 58 normotensive women. Preclinical PE cohort included 149 women whose serum samples were collected at 8−14 gestational weeks and in whom 30 women later developed mild and 40 severe PE. Serum proteome was analyzed and enzyme-linked immunosorbent assays were used for protein quantification. In Clinical PE, fibronectin, pappalysin-2, choriogonadotropin-β, apolipoprotein C-III, cystatin-C, vascular endothelial growth factor receptor-1, and endoglin were more abundant compared to normotensive women. In preclinical PE, differently expressed proteins included placental, vascular, transport, matrix, and acute phase proteins. Angiogenic and antiangiogenic proteins were not significant. We conclude that placental and antiangiogenic proteins are abundant in clinical PE. In preclinical PE, proteomic profile is distinct and different from that in clinical PE.