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Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.
Treatment for hoarding disorder is typically performed by mental health professionals, potentially limiting access to care in underserved areas.
We aimed to conduct a non-inferiority trial of group peer-facilitated therapy (G-PFT) and group psychologist-led cognitive–behavioural therapy (G-CBT).
We randomised 323 adults with hording disorder 15 weeks of G-PFT or 16 weeks of G-CBT and assessed at baseline, post-treatment and longitudinally (≥3 months post-treatment: mean 14.4 months, range 3–25). Predictors of treatment response were examined.
G-PFT (effect size 1.20) was as effective as G-CBT (effect size 1.21; between-group difference 1.82 points, t = −1.71, d.f. = 245, P = 0.04). More homework completion and ongoing help from family and friends resulted in lower severity scores at longitudinal follow-up (t = 2.79, d.f. = 175, P = 0.006; t = 2.89, d.f. = 175, P = 0.004).
Peer-led groups were as effective as psychologist-led groups, providing a novel treatment avenue for individuals without access to mental health professionals.
Declaration of interest
C.A.M. has received grant funding from the National Institutes of Health (NIH) and travel reimbursement and speakers’ honoraria from the Tourette Association of America (TAA), as well as honoraria and travel reimbursement from the NIH for serving as an NIH Study Section reviewer. K.D. receives research support from the NIH and honoraria and travel reimbursement from the NIH for serving as an NIH Study Section reviewer. R.S.M. receives research support from the National Institute of Mental Health, National Institute of Aging, the Hillblom Foundation, Janssen Pharmaceuticals (research grant) and the Alzheimer's Association. R.S.M. has also received travel support from the National Institute of Mental Health for Workshop participation. J.Y.T. receives research support from the NIH, Patient-Centered Outcomes Research Institute and the California Tobacco Related Research Program, and honoraria and travel reimbursement from the NIH for serving as an NIH Study Section reviewer. All other authors report no conflicts of interest.
The authors developed a practical and clinically useful model to predict the risk of psychosis that utilizes clinical characteristics empirically demonstrated to be strong predictors of conversion to psychosis in clinical high-risk (CHR) individuals. The model is based upon the Structured Interview for Psychosis Risk Syndromes (SIPS) and accompanying clinical interview, and yields scores indicating one's risk of conversion.
Baseline data, including demographic and clinical characteristics measured by the SIPS, were obtained on 199 CHR individuals seeking evaluation in the early detection and intervention for mental disorders program at the New York State Psychiatric Institute at Columbia University Medical Center. Each patient was followed for up to 2 years or until they developed a syndromal DSM-4 disorder. A LASSO logistic fitting procedure was used to construct a model for conversion specifically to a psychotic disorder.
At 2 years, 64 patients (32.2%) converted to a psychotic disorder. The top five variables with relatively large standardized effect sizes included SIPS subscales of visual perceptual abnormalities, dysphoric mood, unusual thought content, disorganized communication, and violent ideation. The concordance index (c-index) was 0.73, indicating a moderately strong ability to discriminate between converters and non-converters.
The prediction model performed well in classifying converters and non-converters and revealed SIPS measures that are relatively strong predictors of conversion, comparable with the risk calculator published by NAPLS (c-index = 0.71), but requiring only a structured clinical interview. Future work will seek to externally validate the model and enhance its performance with the incorporation of relevant biomarkers.
Posthodiplostomum minimum utilizes a three-host life cycle with multiple developmental stages. The metacercarial stage, commonly known as ‘white grub’, infects the visceral organs of many freshwater fishes and was historically considered a host generalist due to its limited morphological variation among a wide range of hosts. In this study, infection data and molecular techniques were used to evaluate the host and tissue specificity of Posthodiplostomum metacercariae in centrarchid fishes. Eleven centrarchid species from three genera were collected from the Illinois portion of the Ohio River drainage and necropsied. Posthodiplostomum infection levels differed significantly by host age, host genera and infection locality. Three Posthodiplostomum spp. were identified by DNA sequencing, two of which were relatively common within centrarchid hosts. Both common species were host specialists at the genus level, with one species restricted to Micropterus hosts and the other preferentially infecting Lepomis. Host specificity is likely dictated by physiological compatibility and deviations from Lepomis host specificity may be related to host hybridization. Posthodiplostomum species also differed in their utilization of host tissues. Neither common species displayed strong genetic structure over the scale of this study, likely due to their utilization of bird definitive hosts.
Aguinis et al. (2017) contribute interesting analyses of cited sources in contemporary undergraduate industrial-organizational (I-O) psychology textbooks and continue their ongoing investigation into the long-term viability of I-O psychology as a unique discipline (see Aguinis, Bradley, & Brodersen, 2014). These analyses, conducted by authors who are members of business schools, attempt to answer questions related to the nature of work conducted by I-O psychologists, comparing the quality and importance of work conducted by faculty in business schools with that conducted by faculty in psychology departments. One of their general themes is that members of business schools are conducting important research that is influencing the future of I-O psychology by overtaking undergraduate textbooks. As such, the article has the feel of a conquering hero taunting its vanquished foe.
The Taipan galaxy survey (hereafter simply ‘Taipan’) is a multi-object spectroscopic survey starting in 2017 that will cover 2π steradians over the southern sky (δ ≲ 10°, |b| ≳ 10°), and obtain optical spectra for about two million galaxies out to z < 0.4. Taipan will use the newly refurbished 1.2-m UK Schmidt Telescope at Siding Spring Observatory with the new TAIPAN instrument, which includes an innovative ‘Starbugs’ positioning system capable of rapidly and simultaneously deploying up to 150 spectroscopic fibres (and up to 300 with a proposed upgrade) over the 6° diameter focal plane, and a purpose-built spectrograph operating in the range from 370 to 870 nm with resolving power R ≳ 2000. The main scientific goals of Taipan are (i) to measure the distance scale of the Universe (primarily governed by the local expansion rate, H0) to 1% precision, and the growth rate of structure to 5%; (ii) to make the most extensive map yet constructed of the total mass distribution and motions in the local Universe, using peculiar velocities based on improved Fundamental Plane distances, which will enable sensitive tests of gravitational physics; and (iii) to deliver a legacy sample of low-redshift galaxies as a unique laboratory for studying galaxy evolution as a function of dark matter halo and stellar mass and environment. The final survey, which will be completed within 5 yrs, will consist of a complete magnitude-limited sample (i ⩽ 17) of about 1.2 × 106 galaxies supplemented by an extension to higher redshifts and fainter magnitudes (i ⩽ 18.1) of a luminous red galaxy sample of about 0.8 × 106 galaxies. Observations and data processing will be carried out remotely and in a fully automated way, using a purpose-built automated ‘virtual observer’ software and an automated data reduction pipeline. The Taipan survey is deliberately designed to maximise its legacy value by complementing and enhancing current and planned surveys of the southern sky at wavelengths from the optical to the radio; it will become the primary redshift and optical spectroscopic reference catalogue for the local extragalactic Universe in the southern sky for the coming decade.
Methiozolin is a selective herbicide that has been reported to control annual bluegrass in creeping bentgrass putting greens. Golf course managers frequently tank-mix fertilizers with herbicides to reduce time and labor, but no information is available regarding such mixtures with methiozolin. Research was conducted to evaluate methiozolin for annual bluegrass control and creeping bentgrass safety when tank-mixed with ammonium sulfate or iron sulfate. Mixtures with ammonium sulfate did not influence annual bluegrass control while they did reduce creeping bentgrass injury in some instances. Mixtures with iron sulfate varied by experimental run but annual bluegrass control was either similar or increased while creeping bentgrass injury did not vary. Paclobutrazol was included as an alternative agrochemical comparison for annual bluegrass management; its application resulted in similar control and injury with and without iron sulfate addition, and injury and control were similar to methiozolin at appropriate rates. While some differences were observed, overall annual bluegrass and creeping bentgrass response to methiozolin was not affected by tank-mix nutrient partner relative to methiozolin applied alone.
The Coronal Solar Magnetism Observatory (CoSMO) is a proposed new facility led by the High Altitude Observatory and a consortium of partners to measure magnetic field and plasma properties in a large (one degree) field of view extending down to the inner parts of the solar corona. CoSMO is intended as a research facility that will advance the understanding and prediction of space weather. The instrumentation elements of CoSMO are: a white-light coronagraph (KCor), already operational at the Mauna Loa Solar Observatory (MLSO); the Chromosphere and Prominence Magnetometer (ChroMag), due for deployment to MLSO next year; and the CoSMO Large Coronagraph (LC) which has completed Preliminary Design Review.
Military personnel generally under-consume n-3 fatty acids and overconsume n-6 fatty acids. In a placebo-controlled, double-blinded study, we investigated whether a diet suitable for implementation in military dining facilities and civilian cafeterias could benefit n-3/n-6 fatty acid status of consumers. Three volunteer groups were provided different diets for 10 weeks. Control (CON) participants consumed meals from the US Military’s Standard Garrison Dining Facility Menu. Experimental, moderate (EXP-Mod) and experimental-high (EXP-High) participants consumed the same meals, but high n-6 fatty acid and low n-3 fatty acid containing chicken, egg, oils and food ingredients were replaced with products having less n-6 fatty acids and more n-3 fatty acids. The EXP-High participants also consumed smoothies containing 1000 mg n-3 fatty acids per serving, whereas other participants received placebo smoothies. Plasma and erythrocyte EPA and DHA in CON group remained unchanged throughout, whereas EPA, DHA and Omega-3 Index increased in EXP-Mod and EXP-High groups, and were higher than in CON group after 5 weeks. After 10 weeks, Omega-3 Index in EXP-High group had increased further. No participants exhibited changes in fasting plasma TAG, total cholesterol, LDL, HDL, mood or emotional reactivity. Replacing high linoleic acid (LA) containing foods in dining facility menus with similar high oleic acid/low LA and high n-3 fatty acid foods can improve n-6/n-3 blood fatty acid status after 5 weeks. The diets were well accepted and suitable for implementation in group feeding settings like military dining facilities and civilian cafeterias.
The main question that Firestone & Scholl (F&S) pose is whether “what and how we see is functionally independent from what and how we think, know, desire, act, and so forth” (sect. 2, para. 1). We synthesize a collection of concerns from an interdisciplinary set of coauthors regarding F&S's assumptions and appeals to intuition, resulting in their treatment of visual perception as context-free.
Objectives: To summarize the clinical characteristics and outcomes of pediatric sports-related concussion (SRC) patients who were evaluated and managed at a multidisciplinary pediatric concussion program and examine the healthcare resources and personnel required to meet the needs of this patient population. Methods: We conducted a retrospective review of all pediatric SRC patients referred to the Pan Am Concussion Program from September 1st, 2013 to May 25th, 2015. Initial assessments and diagnoses were carried out by a single neurosurgeon. Return-to-Play decision-making was carried out by the multidisciplinary team. Results: 604 patients, including 423 pediatric SRC patients were evaluated at the Pan Am Concussion Program during the study period. The mean age of study patients was 14.30 years (SD: 2.32, range 7-19 years); 252 (59.57%) were males. Hockey (182; 43.03%) and soccer (60; 14.18%) were the most commonly played sports at the time of injury. Overall, 294 (69.50%) of SRC patients met the clinical criteria for concussion recovery, while 75 (17.73%) were lost to follow-up, and 53 (12.53%) remained in active treatment at the end of the study period. The median duration of symptoms among the 261 acute SRC patients with complete follow-up was 23 days (IQR: 15, 36). Overall, 25.30% of pediatric SRC patients underwent at least one diagnostic imaging test and 32.62% received referral to another member of our multidisciplinary clinical team. Conclusion: Comprehensive care of pediatric SRC patients requires access to appropriate diagnostic resources and the multidisciplinary collaboration of experts with national and provincially-recognized training in TBI.
Annual bluegrass is a weed species in turfgrass environments known for exhibiting resistance to multiple herbicide modes of action, including photosystem II (PSII) inhibitors. To evaluate populations of annual bluegrass for susceptibility to PSII inhibitors of varied chemistries, populations were treated with herbicides from triazolinone, triazine, and substituted urea families: amicarbazone, atrazine, and diuron, respectively. Sequencing of the psbA gene confirmed the presence of a Ser264 to Gly amino acid substitution within populations that exhibited resistance to both atrazine and amicarbazone. A single biotype, DR3, which lacked any previously reported psbA gene point mutation, exhibited resistance to diuron, atrazine, and amicarbazone. DR3 had a significantly lower rate of absorption and translocation of atrazine and had enhanced atrazine metabolism when compared with both the Ser264 to Gly resistant mutant and susceptible biotypes. We thus report possible nontarget mechanisms of resistance to PSII-inhibiting herbicides in annual bluegrass.
Varved sediments of the tropical Cariaco Basin provide a new 14C calibration data set for the period of deglaciation (10,000 to 14,500 years before present: 10–14.5 cal ka bp). Independent evaluations of the Cariaco Basin calendar and 14C chronologies were based on the agreement of varve ages with the GISP2 ice core layer chronology for similar high-resolution paleoclimate records, in addition to 14C age agreement with terrestrial 14C dates, even during large climatic changes. These assessments indicate that the Cariaco Basin 14C reservoir age remained stable throughout the Younger Dryas and late Allerød climatic events and that the varve and 14C chronologies provide an accurate alternative to existing calibrations based on coral U/Th dates. The Cariaco Basin calibration generally agrees with coral-derived calibrations but is more continuous and resolves century-scale details of 14C change not seen in the coral records. 14C plateaus can be identified at 9.6, 11.4, and 11.7 14C ka bp, in addition to a large, sloping “plateau” during the Younger Dryas (∼10 to 11 14C ka bp). Accounting for features such as these is crucial to determining the relative timing and rates of change during abrupt global climate changes of the last deglaciation.
WSe2 films have been fabricated using a low-temperature, two-step method involving the reaction of W(CO)6 and elemental selenium in refluxing (110 °C) toluene to form a nanocrystalline precursor consisting of amorphous tungsten and trigonal crystalline selenium. Drop cast or airbrush-deposited films of this precursor were annealed in an argon atmosphere using a two-step temperature ramp (250 °C for 15 min followed by 550 °C for 30 min). Raman and x-ray diffraction (XRD) characterization as well as the measured bandgaps of the resulting films are consistent with (002)-oriented WSe2 and are compared to the characterization of films produced via selenization of sputtered tungsten films in closed quartz tubes at 875 °C.