Assessing the illegal hunting of native wildlife in China.

Illegal harvesting and trading of wildlife have become major threats to global biodiversity and public health1-3. Although China is widely recognized as an important destination for wildlife illegally obtained abroad4, little attention has been given to illegal hunting within its borders. Here we extracted 9,256 convictions for illegal hunting from a nationwide database of trial verdicts in China spanning January 2014 to March 2020. These convictions involved illegal hunting of 21% (n = 673) of China's amphibian, reptile, bird and mammal species, including 25% of imperilled species in these groups. Sample-based extrapolation indicates that many more species were taken illegally during this period. Larger body mass and range size (for all groups), and proximity to urban markets (for amphibians and birds) increase the probability of a species appearing in the convictions database. Convictions pertained overwhelmingly to illegal hunting for commercial purposes and involved all major habitats across China. A small number of convictions represented most of the animals taken, indicating the existence of large commercial poaching operations. Prefectures closer to urban markets show higher densities of convictions and more individual animals taken. Our results suggest that illegal hunting is a major, overlooked threat to biodiversity throughout China.

Nationwide law enforcement impact on the pet bird trade in China.

Conservation enforcement is a direct strategy to combat illegal wildlife trade in open markets. Yet, its large-scale effectiveness has not been widely assessed due to the lack of extensive market data. Between August 2016 and June 2017, a national coordinated enforcement campaign led by the leading Chinese authority to combat illegal migratory bird trade coincided with the largest-ever pet bird market survey across China by voluntary birdwatchers before and after the enforcement, which served as a unique natural experiment. Across 73 markets from 22 Chinese provinces, the dataset contains 140,723 birds of 346 species from 48 families and recorded a drastic decline in bird abundance traded after enforcement. Notably, species protected under China's Wildlife Protection Law declined significantly, while commercially bred species increased, although responses to enforcement were spatially heterogeneous. Our model showed that the national protection level was the best predictor for the trend of traded species, even after accounting for confounding factors such as regional baseline enforcement pressure and wild native bird populations. However, the widely traded native songbirds were not offered adequate national protection. Future policies should consider the pet bird trade patterns, target key areas of trade, and develop a more systematic market survey design to monitor trade.

First-night effect in insomnia disorder: a systematic review and meta-analysis of polysomnographic findings.

Polysomnographic studies have been performed to investigate the first-night effect in insomnia disorder. However, these studies have revealed discrepant findings. This meta-analysis aimed to summarise and quantify the characteristics of the first-night effect in insomnia disorder. We performed a systematic search of the PubMed, Medline, EMBASE, Web of Science and PsycINFO databases to identify studies published through October 2019. A total of 11,862 articles were identified, and seven studies with eight independent populations were included in the meta-analysis. A total of 639 patients with insomnia disorder and 171 healthy controls underwent more than 2 consecutive nights of in-laboratory polysomnography. Pooled results demonstrated that both variables of sleep continuity and sleep architecture, other than slow-wave sleep were significantly altered in the first-night effect in insomnia disorder. Furthermore, the results indicated that patients with insomnia disorder had a disruption of sleep continuity in the first-night effect, including increased sleep onset latency and reduced total sleep time, compared to healthy controls. Overall, the findings show that patients with insomnia disorder experience the first-night effect, rather than reverse first-night effect, and the profiles of the first-night effect in patients with insomnia are different from healthy controls. These indicate that an adaptation night is necessary when sleep continuity and sleep architecture is to be studied in patients with insomnia disorder. More well-designed studies with large samples are needed to confirm the results.

Quantifying species biases among multidata sources on illegal wildlife trade and its implications for conservation.

Unsustainable wildlife consumption and illegal wildlife trade (IWT) threaten biodiversity worldwide. Although publicly accessible data sets are increasingly used to generate insights into IWT, little is known about their potential bias. We compared three typical and temporally corresponding data sets (4204 court verdicts, 926 seizure news reports, and 219 bird market surveys) on traded birds native to China and evaluated their possible species biases. Specifically, we evaluated bias and completeness of sampling for species richness, phylogeny, conservation status, spatial distribution, and life-history characteristics among the three data sets when determining patterns of illegal trade. Court verdicts contained the largest species richness. In bird market surveys and seizure news reports, phylogenetic clustering was greater than that in court verdicts, where songbird species (i.e., Passeriformes) were detected in higher proportions in market surveys. The seizure news data set contained the highest proportion of species of high conservation priority but the lowest species coverage. Across the country, all data sets consistently reported relatively high species richness in south and southwest regions, but markets revealed a northern geographic bias. The species composition in court verdicts and markets also exhibited distinct geographical patterns. There was significant ecological trait bias when we modeled whether a bird species is traded in the market. Our regression model suggested that species with small body masses, large geographical ranges, and a preference for anthropogenic habitats and those that are not nationally protected were more likely to be traded illegally. The species biases we found emphasize the need to know the constraints of each data set so that they can optimally inform strategies to combat IWT.

Cuantificación del sesgo por especies entre fuentes de datos múltiples para el mercado ilegal de fauna y lo que implica para la conservación Resumen El consumo insostenible y el comercio ilegal de fauna y flora silvestres amenazan la biodiversidad en todo el mundo. Aunque los conjuntos de datos de acceso público se utilizan cada vez más para obtener información sobre el mercado ilegal de especies silvestres, se sabe poco sobre su posible sesgo. Comparamos tres conjuntos de datos típicos con correspondencia temporal (4,204 sentencias judiciales, 926 informes de noticias sobre incautaciones y 219 encuestas sobre mercados de aves) de aves autóctonas de China objeto de comercio y evaluamos sus posibles sesgos por especie. En concreto, evaluamos el sesgo y la exhaustividad del muestreo de la riqueza de especies, la filogenia, el estado de conservación, la distribución espacial y las características del ciclo vital entre los tres conjuntos de datos a la hora de determinar los patrones del mercado ilegal. Las sentencias judiciales contenían la mayor riqueza de especies. En los estudios de mercado de aves y en los informes de noticias sobre incautaciones, la agrupación filogenética fue mayor que en las sentencias judiciales, donde las especies de aves canoras (Passeriformes) se detectaron en mayor proporción en los estudios de mercado. El conjunto de datos de noticias sobre decomisos contenía la mayor proporción de especies de alta prioridad para la conservación, pero la menor cobertura de especies. En todo el país, todos los conjuntos de datos informaron sistemáticamente de una riqueza de especies relativamente alta en las regiones sur y suroeste, pero los mercados revelaron un sesgo geográfico septentrional. La composición por especies en los veredictos judiciales y en los mercados también mostró patrones geográficos distintos. Hubo un sesgo significativo de rasgos ecológicos cuando modelamos si una especie de ave se comercializa en el mercado. Nuestro modelo de regresión sugería que las especies con masas corporales pequeñas, grandes áreas de distribución geográfica y preferencia por los hábitats antropogénicos y las especies que no están protegidas a nivel nacional tenían más probabilidades de ser objeto de comercio ilegal. Los sesgos de las especies que hallamos resaltan la necesidad de conocer las limitaciones de cada conjunto de datos para poder informar de manera óptima las estrategias de lucha contra el comercio ilegal de especies silvestres.

The insensitivity of sleep to an unfamiliar sleeping environment in patients with insomnia disorder.

BACKGROUND: Sleeping in an unfamiliar environment, such as a sleep laboratory, is thought to disturb sleep in healthy individuals and could express a hyperarousal state called the first night effect. Insomnia disorder (ID) is a highly prevalent health problem characterized by increased arousal during the night and daytime. Whether or not a similar phenomenon occurs in patients with ID is unclear. This study aimed to investigate the effect of an unfamiliar environment on the sleep of patients with ID. METHODS: In an unfamiliar sleep laboratory, polysomnographic recording testing was performed for two consecutive nights in patients with ID and age- and sex-matched healthy control subjects (HC). We collected sleep diaries and questionnaires regarding sleep, medical conditions, psychological status, and health history. Sleep continuity and architecture in both groups were compared and analyzed for two consecutive nights. RESULTS: Participants with ID (n = 39)  and HC (n = 35) demonstrated differentially poor sleep on laboratory adaptation after exposure to the sleep laboratory. Patients with ID had longer rapid eye movement (REM) latency on the first night than on the second sleep night. HC showed increased duration and percentage of N1, decreased duration and percentage of N3, and decreased REM percentage during initial nights compared to subsequent nights. The other sleep variables showed no differences between the first and second sleep nights in patients with ID and HC. CONCLUSIONS: An unfamiliar sleep environment does not aggravate the disruption of sleep continuity and sleep architecture but only affects the REM latency in patients with ID compared with HC.

Citrus FRIGIDA cooperates with its interaction partner dehydrin to regulate drought tolerance.

Drought is a major environmental stress that severely affects plant growth and crop productivity. FRIGIDA (FRI) is a key regulator of flowering time and drought tolerance in model plants. However, little is known regarding its functions in woody plants, including citrus. Thus, we explored the functional role of the citrus FRI ortholog (CiFRI) under drought. Drought treatment induced CiFRI expression. CiFRI overexpression enhanced drought tolerance in transgenic Arabidopsis and citrus, while CiFRI suppression increased drought susceptibility in citrus. Moreover, transcriptomic profiling under drought conditions suggested that CiFRI overexpression altered the expression of numerous genes involved in the stress response, hormone biosynthesis, and signal transduction. Mechanistic studies revealed that citrus dehydrin likely protects CiFRI from stress-induced degradation, thereby enhancing plant drought tolerance. In addition, a citrus brassinazole-resistant (BZR) transcription factor family member (CiBZR1) directly binds to the CiFRI promoter to activate its expression under drought conditions. CiBZR1 also enhanced drought tolerance in transgenic Arabidopsis and citrus. These findings further our understanding of the molecular mechanisms underlying the CiFRI-mediated drought stress response in citrus.

Depression, anxiety, and burnout among psychiatrists during the COVID-19 pandemic: a cross-sectional study in Beijing, China.

BACKGROUND: With the rise of reported mental disorders and behavioral issues after the outbreak of the coronavirus disease 2019 (COVID-19) pandemic, psychiatrists and mental health care are urgently needed more than ever before. The psychiatric career carries a high emotional burden and stressful demands, which bring issues on psychiatrists' mental health and well-being into question. To investigate the prevalence and risk factors of depression, anxiety, and work burnout among psychiatrists in Beijing during the COVID-19 pandemic. METHODS: This cross-sectional survey was conducted from January 6 to January 30, 2022, two years after COVID-19 was declared a global pandemic. Recruitment was performed using a convenience sample approach by sending online questionnaires to psychiatrists in Beijing. The symptoms of depression, anxiety, and burnout were evaluated using the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Maslach Burnout Inventory-General Survey (MBI-GS). The perceived stress and social support were measured by the Chinese Perceived Stress Scale (CPSS) and Social Support Rating Scale (SSRS), respectively. RESULTS: The data of 564 psychiatrists (median [interquartile range] age, 37 [30-43] years old) of all 1532 in Beijing were included in the statistical analysis. The prevalence of symptoms of depression, anxiety and burnout were 33.2% (95% CI, 29.3-37.1%, PHQ-9 ≥ 5), 25.4% (95% CI, 21.8-29.0%, GAD-7 ≥ 5) and 40.6% (95% CI, 36.5-44.7%, MBI-GS ≥ 3 in each of the three subdimensions), respectively. The psychiatrist with a higher score on perceived stress was more likely to suffer from depressive symptoms (adjusted odds ratios [ORs]: 4.431 [95%CI, 2.907-6.752]); the anxiety symptoms (adjusted ORs: 8.280 [95%CI, 5.255-13.049]), and the burnout conditions (adjusted ORs: 9.102 [95%CI, 5.795-14.298]). Receiving high social support was an independent protective factor against symptoms of depression (adjusted ORs: 0.176 [95%CI, [0.080-0.386]), anxiety (adjusted ORs: 0.265 [95%CI, 0.111-0.630]) and burnout (adjusted ORs: 0.319 [95%CI, 0.148-0.686]). CONCLUSIONS: Our data suggest a considerable proportion of psychiatrists also suffer from depression, anxiety, and burnout. Perceived stress and social support influence depression, anxiety, and burnout. For public health, we must work together to reduce the pressure and increase social support to mitigate mental health risks in psychiatrists.

Workforce situation of the Chinese mental health care system: results from a cross-sectional study.

BACKGROUND: High-quality mental health services can improve outcomes for people with mental health problems and abate the burden of mental disorders. We sought to identify the challenges the country's mental health system currently faces and the human resource situation related to psychological services and to provide recommendations on how the mental health workforce situation could be addressed in China. METHODS: This study used a cross-sectional survey design. A web-based questionnaire approach and a convenience sampling method were adopted. It was carried out from September 2020 to January 2021 in China, and we finally included 3824 participants in the analysis. Descriptive statistical analysis of the characteristics of the study sample was performed. The risk factors for competence in psychological counseling/psychotherapy were assessed using multiple linear regression analysis. RESULTS: Workforce related to psychotherapy is scarce in China, especially in Western China and community mental health sectors. Psychiatrists (39.1%) and nurses (38.9%) were the main service providers of psychotherapy in psychiatric hospitals, and clinical psychologists (6.9%) and counsellors (5.0%) were seriously scarce in mental health care sectors. A total of 74.2% of respondents had no systematic psychological training, and 68.4 and 69.2% of them had no self-experience and professional supervision, respectively. Compared with clinical psychologists and counselors, psychiatrists and nurses had less training. Systematic psychological training (ß = - 0.88), self-experience (ß = - 0.59) and professional supervision (ß = - 1.26) significantly influenced psychotherapy capacity (P<0.001). CONCLUSIONS: Sustained effort will be required to provide a high-quality, equitably distributed psychotherapy workforce in China, despite challenges for community mental health sectors and western China being likely to continue for some time. Because mental illness is implicated in so many burgeoning social ills, addressing this shortfall could have wide-ranging benefits.

Two citrus KNAT-like genes, CsKN1 and CsKN2, are involved in the regulation of spring shoot development in sweet orange.

Shoot-tip abortion is a very common phenomenon in some perennial woody plants and it affects the height, architecture, and branch orientation of trees; however, little is currently known about the underlying mechanisms. In this study, we identified a gene in sweet orange (Citrus sinensis) encoding a KNAT-like protein (CsKN1) and found high expression in the shoot apical meristem (SAM). Overexpression of CsKN1 in transgenic plants prolonged the vegetative growth of SAMs, whilst silencing resulted in either the loss or inhibition of SAMs. Yeast two-hybrid analysis revealed that CsKN1 interacted with another citrus KNAT-like protein (CsKN2), and overexpression of CsKN2 in lemon and tobacco caused an extreme multiple-meristem phenotype. Overexpression of CsKN1 and CsKN2 in transgenic plants resulted in the differential expression of numerous genes related to hormone biosynthesis and signaling. Yeast one-hybrid analysis revealed that the CsKN1-CsKN2 complex can bind to the promoter of citrus floral meristem gene LEAFY (CsLFY) and inhibit its expression. These results indicated that CsKN1 might prolong the vegetative growth period of SAMs by delaying flowering. In addition, an ethylene-responsive factor (CsERF) was found to bind to the CsKN1 promoter and suppresses its transcription. Overexpression of CsERF in Arabidopsis increased the contents of ethylene and reactive oxygen species, which might induce the occurrence of shoot-tip abscission. On the basis of our results, we conclude that CsKN1 and CsKN2 might work cooperatively to regulate the shoot-tip abscission process in spring shoots of sweet orange.

Suppressor of rid1 (SID1) shares common targets with RID1 on florigen genes to initiate floral transition in rice.

The transition from vegetative to reproductive growth is a critical process in the life cycle of higher plants. Previously, we cloned Rice Indeterminate 1 (RID1), which acts as the master switch for the transition from the vegetative to reproductive phase in rice. Although the photoperiod pathway of RID1 inducing expression of the florigen genes Hd3a and RFT1 via Ehd1 has been established, the alternative pathways for the essential flowering transition need to be further examined. Here, we identified a Suppressor of rid1 (SID1), which rescues the never-flowering phenotype of rid1. SID1 encodes an INDETERMINATE DOMAIN (IDD) transcription factor. Mutation in SID1 showed the delayed flowering phenotype. Gain-of-function of SID1, OsIDD1, or OsIDD6 could restore the rid1 to flowering. Further analyses showed SID1 and RID1 directly target the promoter regions of Hd3a and RFT1, two florigen genes in rice. Taken together, our results reveal an autonomous flowering pathway might be mediated by RID1, thereby controlling the phase transition from vegetative to reproductive development in rice.

Benefits of napping habits in healthy adults: Maintaining alerting performance and cortisol levels change within 90 min of habitual napping time.

BACKGROUND: Napping is garnering increased attention as a strategy for adults to sustain alertness and alleviate stress in contemporary society. The nuances of napping habits are emerging as an independent factor influencing the extent of individual benefits. This study aimed to demonstrate the long-term benefits of napping and explore the impact of napping habits on individual alertness, as well as whether this effect was correlated with cortisol levels. METHODS: The study involved 80 healthy adults categorized into two groups based on self-reported napping habits: habitual nappers (n = 49) and non-habitual nappers (n = 31). Karolinska Sleepiness Scale (KSS), psychomotor vigilance task (PVT), and saliva collection were performed every 30 min within 90 min in the absence of napping during the afternoon dip. The measurements were analyzed using repeated measures ANOVA and Pearson correlation analyses. RESULTS: There was an interaction between groups and time in reaction speed and lapse number of PVT and cortisol (all p < 0.05). Post hoc analysis found that habitual nappers maintained higher objective alertness and experienced more significant increases in cortisol over time (all p < 0.05). The cortisol levels at sleepiness time were negatively associated with the slowest 10 % reaction speed of PVT in non-habitual nappers (r = -0.409, p = 0.022). CONCLUSION: Under the premise of mitigating the impacts of acute nap deprivation on sleep homeostasis and rhythm, napping habits emerge as a potential factor influencing the ability of individuals to sustain heightened alertness.

Increased connectivity of the anterior cingulate cortex is associated with the tendency to awakening during N2 sleep in patients with insomnia disorder.

STUDY OBJECTIVES: To investigate the relationship between sleep transition dynamics and stage-specific functional connectivity (FC) of the anterior cingulate cortex (ACC) in patients with insomnia disorder (ID). METHODS: Simultaneous electroencephalography-functional magnetic resonance imaging (EEG-fMRI) data from 37 patients with ID and 30 well-matched healthy controls (HCs) were recorded during wakefulness and different sleep stages and subsequently analyzed. A Markov chain model was used to estimate the transition probability between each stage. The FC between the ACC (set as the seed) and voxels across the whole brain was calculated. A linear mixed effect model was used to determine the group-by-stage interaction of the seed-based connectivity. The correlation between the sleep-stage transition probability and the ACC-based connectivity was explored. RESULTS: Patients with ID exhibited a higher likelihood of transitioning from N2 to wakefulness than HCs. A significant group-by-stage interaction of connectivity with the bilateral ACC was observed in the cerebellar, subcortical, and cortical regions. Moreover, a significant positive correlation was found in patients with ID between the transition probability from N2 to wakefulness and the FC of the ACC with the anterior cerebellum in N2 (r = 0.48). CONCLUSIONS: This exploratory analysis indicates that enhanced FC between the ACC and cerebellum represents a potential neural pathway underlying the greater likelihood of patients with ID waking during N2 sleep. These findings contribute to an emerging framework that reveals the link between sleep maintenance difficulty and ACC function, further highlighting the possibility that N2 sleep is a therapeutic target for meaningfully reducing sleep disruption.

Disrupted diurnal oscillations of the gut microbiota in patients with alcohol dependence.

Background: Patients with alcohol dependence (AD) can exhibit gut dysbacteria. Dysbacteria may co-occur with disruptions of circadian rhythmicity of the gut flora, which can aggravate AD. Herein, this study aimed to investigate diurnal oscillations of the gut microbiota in AD patients. Methods: Thirty-two patients with AD, based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, and 20 healthy subjects were enrolled in this study. Demographic and clinical data were collected by self-report questionnaires. Fecal samples at 7:00 AM, 11:00 AM, 3:00 PM, and 7:00 PM were collected from each subject. 16S rDNA sequencing was conducted. Wilcoxon and Kruskal-Wallis tests were performed to characterize alterations and oscillations of the gut microbiota. Results: We found that ß-diversity of the gut microbiota in AD patients oscillated diurnally compared with healthy subjects (p = 0.01). Additionally, 0.66% of operational taxonomic units oscillated diurnally in AD patients versus 1.68% in healthy subjects. At different taxonomic levels, bacterial abundance oscillated diurnally in both groups, such as Pseudomonas and Prevotella pallens (all p < 0.05). ß-diversity of the gut microbiota in AD patients with high daily alcohol consumption, high-level cravings, short AD durations, and mild withdrawal symptoms oscillated diurnally compared with other AD patients (all p < 0.05). Conclusion: The gut microbiota in AD patients exhibits disruptions of diurnal oscillation, which may provide novel insights into mechanisms of AD and the development of therapeutic strategies.

Thalamic network under wakefulness after sleep onset and its coupling with daytime fatigue in insomnia disorder: An EEG-fMRI study.

BACKGROUND: Fatigue is the most common daytime impairment of insomnia disorder (ID). Thalamus is acknowledged as the key brain region closely associated with fatigue. However, the thalamus-based neurobiological mechanisms of fatigue in patients with ID remain unknown. METHODS: Forty-two ID patients and twenty-eight well-matched healthy controls (HCs) underwent simultaneous electroencephalography--functional magnetic resonance imaging. We calculated the functional connectivity (FC) between the thalamic seed and each voxel across the whole brain in two conditions of wakefulness--after sleep onset (WASO) and before sleep onset. A linear mixed effect model was used to determine the condition effect of the thalamic FC. The correlation between daytime fatigue and the thalamic connectivity was explored. RESULTS: After sleep onset, the connectivity with the bilateral thalamus was increased in the cerebellar and cortical regions. Compared with HCs, ID patients showed significantly lower FC between left thalamus and left cerebellum under the WASO condition. Furthermore, thalamic connectivity with cerebellum under the WASO condition was negatively correlated with Fatigue Severity Scale scores in the pooled sample. CONCLUSIONS: These findings contribute to an emerging framework that reveals the link between insomnia-related daytime fatigue and the altered thalamic network after sleep onset, further highlighting the possibility that this neural pathway is a therapeutic target for meaningfully mitigating fatigue.

Understanding the social impacts of enforcement activities on illegal wildlife trade in China.

Illegal wildlife trade enforcement is a cornerstone conservation strategy worldwide, yet we have a limited understanding on its social impacts. Using Chinese online wildlife seizure news (2003-2018), we evaluated the interactions among enforcement operations, news frequency, and social engagement (i.e., whistle-blowing) frequency. Our results showed that intensive enforcement operations, which commenced after 2012, have social impacts by increasing the frequency of all seizure news significantly by 28% [95% Confidence Interval (CI): 5%, 51%] and those via whistle-blowing by 24% [95% CI: 2%, 45%], when compared to counterfactual models where possible confounding factors were accounted for. Furthermore, we revealed the potential interaction between enforcement seizure news with and without social engagement, and the consequential social feedback process. Of the species identified from 'whistle-blowing' news, up to 28% are considered as high conservation priorities. Overall, we expanded our understanding of the enforcement impacts to social dimensions, which could contribute to improving the cost-effectiveness of such conservation efforts.

Sleep discrepancy is associated with alterations in the salience network in patients with insomnia disorder: An EEG-fMRI study.

BACKGROUND: Positron emission tomography - computed tomography (PET-CT) research has shown that sleep discrepancy recorded by self-report and polysomnography (PSG) may be related to the altered metabolic rate of the anterior insula (aINS) during non-rapid eye movement (NREM) sleep in patients with insomnia disorder. We aim to explore the functional connectivity of aINS across wake and NREM sleep in the patients and to reveal the association between aINS connectivity and sleep discrepancy. METHODS: Patients with insomnia disorder (n = 33) and healthy controls (n = 31) underwent simultaneous electroencephalography and functional magnetic resonance imaging (EEG-fMRI) during nighttime sleep, and aINS-based connectivity was calculated across wake and NREM sleep. A linear mixed-effects model was used to assess the main effect of group and group-by-stage (wake, NREM stages 1-3) interaction effect on aINS connectivity. Similar mixed models were used to assess the potential correlation between aINS connectivity and the sleep misperception index (MI). RESULTS: A significant group-by-stage interaction effect on aINS-based connectivity was observed in the bilateral frontal gyrus, right inferior temporal gyrus, bilateral middle occipital gyrus and right postcentral gyrus (p < 0.05, corrected). There was also a significant group-by-MI interaction effect on aINS connectivity with the putamen and thalamus during wakefulness (p < 0.05 corrected); MI was significantly associated with aINS-putamen/thalamus connectivity in the control group, whereas the association was weak or even nonsignificant in the patient group. There was no significant main effect of group. CONCLUSION: The waking activity of a neural pathway containing the aINS, putamen, and thalamus may underlie sleep perception, potentially providing important perspectives to reveal complex mechanisms of sleep discrepancy between self-report and PSG.

The use of real-world data/evidence in regulatory submissions.

The 21st Century Cures Act passed by the United States (US) Congress in December 2016 requires the US Food and Drug Administration (FDA) shall establish a program to evaluate the potential use of real-world evidence (RWE) which is generated from real-world data (RWD) to (i) support approval of new indication for a drug approved under section 505 (c) and (ii) satisfy post-approval study requirements. RWE offers the opportunities to develop robust evidence using high-quality data and sophisticated methods for producing causal-effect estimates regardless randomization is feasible. In this article, we have demonstrated that the assessment of treatment effect (RWE) based on RWD could be biased due to the potential selection and information biases of RWD. Although fit-for-purpose RWE may meet regulatory standards under certain assumptions, it is not the same as substantial evidence (current regulatory standard in support of approval of regulatory submission). In practice, it is then suggested that when there are gaps between fit-for-purpose RWE and substantial evidence, we should make efforts to fill these gaps based on a comprehensive evaluation of the treatment effect. We also review two RWE examples to show some potential use of RWE in clinical studies.

Status and Correlates of Hypersomnia in Hospitalized Patients with Unipolar Depression - Beijing, Henan, and Shandong, China, August 2019-March 2021.

WHAT IS ALREADY KNOWN ABOUT THIS TOPIC?: Hypersomnia is an atypical characteristic of unipolar depression (UD), indicating a high risk of bipolar depression. Identifying the symptom should be prioritized in patients with UD. However, the status and correlated factors of hypersomnia greatly varied across investigations. WHAT IS ADDED BY THIS REPORT?: Among inpatients with UD, the rate of hypersomnia was roughly 28.1% (39/139). Younger age (18-35 years) and recurrent depression were independent correlates of hypersomnia in hospitalized patients with UD. WHAT ARE THE IMPLICATIONS FOR PUBLIC HEALTH PRACTICE?: Understanding the high rate and independent correlates of hypersomnia in hospitalized patients with UD will help clinicians and policymakers to identify characteristics of depression, strengthen the management capacity and improve the quality of treatment and control programs.

The influence of placebo administration on the first- night effect in patients with insomnia disorder.

OBJECTIVE: We aimed to investigate the effects of placebo on the first-night effect (FNE) in insomniacs. METHODS: In sum, 36 patients with insomnia disorder who met the DSM-5 criteria were enrolled in this study. Sixteen patients with insomnia disorder were given two days of placebo intervention (placebo-administration group, PL). Twenty patients with insomnia disorder (drug-free group, DF) were not given any interventions. All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory. Sleep diaries were recorded during one week at home before the PSG nights and on two subsequent nights. RESULTS: The results demonstrated that compared with the DF group, sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO) significantly increased and sleep efficiency (SE) significantly decreased in the first sleep lab night in the PL group (all p < 0.05). Moreover, compared with the second night, significant differences were observed in lower self-reported total sleep time (TST) and more subjective WASO during the first night in the PL group (all p < 0.05). However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups. CONCLUSION: In patients with insomnia disorder, placebo administration may increase the occurrence of worse sleep without causing a change in the duration and percentage of N1, N2, N3 and REM on the first sleep lab night. In some cases, a placebo may not serve as treatment but may result in a nocebo effect.