Expert consensus, as an important supplement to clinical practice guidelines, supports clinical decision-making when evidence is lacking or controversial. Compared to clinical practice guidelines, the presentation of expert consensus is more diverse. Currently, there are no reporting guidelines for expert consensus in clinical and public health decision-making. The RIGHT (Reporting Items for Practice Guidelines in Healthcare) checklist is the most commonly used international guideline reporting standard, and is often referred to when writing expert consensus. However, the RIGHT checklist does not include a section on consensus formation methods; while the ACCORD (ACcurate COnsensus Reporting Document) checklist includes reporting requirements for consensus formation methods, but not for reporting recommendations. Therefore, this article integrates the RIGHT and ACCORD reporting checklists and proposes an integrated reporting framework (TIMER-DO) to help authors combine these two commonly used international reporting standards and complete the standardized reporting of expert consensus.

Objective To study the effects of vision on human postural control and the connection mechanisms of the brain's functional network.Methods 15 healthy male adults were required to perform 30 s of balanced standing on both legs with eyes open and eyes closed.The center of pressure(COP)and electroencephalograph(EEG)were recorded during balance.The sample entropy(sample En)of the COP was calculated.The phase lag index(PLI)in θ-,α-,β-band of EEG was calculated to construct the brain functional networks,and the clustering coefficient(C),characteristic path length(L),and the criteria(σ)of the small-world network were calculated based on graph theory.Results During balanced standing on both legs,the SampleEn of the COPY with eyes closed was significantly higher than that with eyes open(P＜0.05).The mean value of PLI in the α-band under the eyes closed state was significantly higher than that under the eyes open state(P＜0.05).The C and σ values in the α-band under the eyes closed state were significantly higher than those under the eyes open state,and the L value was significantly lower than that under the eyes open state(P＜0.05).The frontal-central-parietal connectivity and the central-parietal connectivity strength in the α-band under the eyes closed state were significantly higher than those under the eyes open state(P＜0.05).The average PLI and C values in the α-band were moderately negatively correlated with the SampleEn of COPY (P＜0.05).The average PLI of the left prefrontal area,left parietal area,and left occipital area in the α-band under the eyes closed state had a moderate negative correlation with the SampleEn of COPY.The average PLI of the left central region and the right occipital area in the eyes-closed state was moderately negatively correlated with the SampleEn of COPY.Conclusions During the standing balance,when there is no visual input,the stability of body balance decreases,accompanied by enhanced brain network connectivity in α-band and the requirement for efficiency enhancement in information processing in the brain.The brain adopts different neural strategies when performing postural control under various visual conditions.

Objective Explore a non-contact physiological and psychological detection model based on facial video in simulations of weightlessness effects,research new methods for non-contact heart rate and negative mood state detection in long-term simulations of weightlessness effect analysis.Methods Construct a non-contact physiological and psychological data collection system for fusion analysis of visible light and thermal infrared videos.Collect physiological and psychological data of volunteers in the"Earth Star-Ⅱ"90-day head-down bed rest experiment.A non-contact heart rate detection model based on GCN facial multi-region feature fusion and a non-contact negative mood state detection model considering data reliability were constructed,and the effectiveness of the models were validated with finger clip heart rate and POMS-SF scale as labels.Results The experimental results show that the average difference in the Bland-Altman plot of the non-contact heart rate detection model is-1.26 bpm,and 96.3%of value error detection data falls within the 95%confidence interval,indicating a high consistency between the model detected heart rate and the finger clip heart rate.The non-contact negative mood state detection model achieves an accuracy of>0.85 for detecting tension,depression,anger,and fatigue.Features such as heart rate,AU06,eye gaze,and head pose were observed to be important to mood state detection.Conclusion Non-contact physiological and psychological detection methods not only can be utilized for long-term physiological analysis in simulations of weightlessness effects,but also provide a novel technical approach for on-orbit astronauts health assurance during long-term space flight in the future.

CRISPR-Associated Protein 9 ; Gene Editing ; CRISPR-Cas Systems/genetics*

Objective:To provide consistent data basis for the application of reference intervals for children blood cell analysis in different testing systems.Methods:According to the requirements of American Institute for Clinical and Laboratory Standardization (CLSI) EP9-A3 document, 45 samples were collected and Sysmex XN20-A1 were used as reference system. Beckman DxH800, Siemens ADVIA 2120i, and Mindray BC5310 were comparison systems. Complete blood count and leukocyte classification were performed by four systems. The outliers of the detection results were tested by the generalized extreme student deviate (ESD) method. An optimal regression model was selected by scatter diagram, deviation diagram and frequency distribution diagram, which was used to fit the regression equation and calculate the deviation at the medical decision level and reference interval. The acceptable range for blood count deviation was cited from the Analytical Quality Specifications for Routine Tests in Clinical Hematology. The acceptable range for leukocyte classification was based on the EQA program of Royal College of Pathologists of Australasia (RCPA).Results:After the outliers were deleted, the scatter plot showed a linear relationship between the reference system and the three comparison systems. The deviation plot showed that the differences were variable. Deming regression or Passing-Bablok regression was selected according to the data distribution. The determination coefficient R2 of reference system and three comparison systems ranged from 0.95 to 0.99 in blood count and leukocyte classification. At the upper and lower limits of the reference interval, the deviations between XN-20A1 and ADVIA 2120 system were all acceptable, except for MONO# at 0.12×10 9/L. The deviations of all parameters at medical decision level were within acceptable ranges. The lower limit of PLT is partially unacceptable at the level of medical decision related to treatment and prognosis. Conclusions:The results of complete blood count and leukocyte classification in reference system and the comparison system had good consistency within the children′s reference interval. Our study provided a scientific basis for the feasibility of adopting a unified reference interval for different detection systems.

The evolution throughout the whole supervision history of Class II/III safety and effectiveness related NMPA submission dossier requirements was studied in this study, meanwhile elaborating the revolution progress of clinical evaluation domestically. The relationship between submission dossier requirements and Essential Principles of Safety and Performance of Medical Devices as well as IMDRF relevant documents was deeply analyzed and illustrated, in order to comprehensively understanding the background and future reform direction of NMPA submission dossier requirements under the background of the government's deepening reform of medical device evaluation and approval system strategy.
China ; Device Approval ; Humans

OBJECTIVE: To investigate the correlation between the severity of obstructive sleep apnea syndrome (OSAS) and red cell distribution width (RDW) in elderly patients. METHODS: A cross-sectional study was conducted among 311 elderly patients diagnosed with OSAS in the snoring clinic between January, 2015 and October, 2016 and 120 healthy controls without OSAS from physical examination populations in the General Hospital of PLA. The subjects were divided into control group with apnea-hypopnea index (AHI) <5 (=120), mild OSAS group (AHI of 5.0-14.9; =90), moderate OSAS group (AHI of 15.0-29.9; =113) and severe OSAS group (AHI ≥ 30; =108). The clinical characteristics and the results of polysomnography, routine blood tests and biochemical tests of the subjects were collected. Multiple linear regression analysis was used to examine the correlation between OSAS severity and RDW. RESULTS: The levels of RDW and triglyceride were significantly higher in severe OSAS group than in the other groups ( < 0.01). The levels of fasting blood glucose and body mass index were significantly higher in severe and moderate OSAS groups than in mild OSAS group and control group ( < 0.05 or < 0.01). Multiple linear regression analysis showed that AHI was positively correlated with body mass index (β=0.111, =0.032) and RDW (β=0.106, =0.029). The area under ROC curve of RDW for predicting the severity of OSAS was 0.687 (=0.0001). CONCLUSIONS The RDW increases as OSAS worsens and may serve as a potential marker for evaluating the severity of OSAS.
Aged ; Cross-Sectional Studies ; Erythrocyte Indices ; Humans ; Polysomnography ; Severity of Illness Index ; Sleep Apnea, Obstructive

Objective: To evaluate the efficacy and safety of sofosbuvir (Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.) combined with ribavirin in patients with genotype 2 chronic hepatitis C virus infection. Methods: Treatment-naïve or treatment experienced genotype 2 chronic hepatitis C patients from sixteen research centers of China were screened. All subjects received once-daily dose of sofosbuvir (400 mg) combined with ribavirin (body weight < 75 kg, 1 000 mg/day, 400 mg in the morning and 600 mg in the evening; body weight > 75 kg, 1 200 mg/d, 600 mg in the morning and 600 mg in the evening) for 12 weeks. Patients were followed-up for a period of 12 weeks after discontinuation of treatment. Continuous variables were expressed as mean ± standard deviation. The proportion of subjects with virologic response at different follow-up time points and 95% confidence intervals were estimated by maximum likelihood ratio and Clopper-Pearson interval. Results: 132 cases with genotype 2 chronic hepatitis C virus infection from sixteen research centers of China were included, 12 cases of whom were associated with cirrhosis, and the remaining 120 cases were not associated with cirrhosis. One hundred and thirty-one cases completed the study, and one patient lost to follow-up at week 4 after the end of treatment. The sustained virological response rate was 96.2% (95% confidence interval: 92.37% - 99.16%) after 12 weeks of drug withdrawal. Virological relapse occurred in four cases. Of the 132 subjects enrolled in the study, 119 (90.2%) reported 617 adverse events during treatment, of which 359 (76.5%) were TEAE related to sofosbuvir and/or ribavirin. There were nine TEAEs of grade 3 and above, and six cases (4.5%) of them had six severe adverse events. Only one serious adverse event was associated with sofosbuvir and ribavirin (unstable angina pectoris). There were no adverse events leading to drug discontinuation or death. Conclusion Sofosbuvir combined with ribavirin has a high SVR rate in the treatment of genotype 2 chronic hepatitis C virus infection, and most of the adverse events occurred were mild with acceptable safety profile.

Objective To explore the relationship between anhedonia,alexithymia and self-efficacy in college students.Methods 260 college students were tested with Snaith-Hamilton Pleasure Scale (SHAPS),Temporal Experience of Pleasure Scale (TEPS),20-item Toronto Alexithymia Scale (TAS-20)and General Self-Efficacy Scale (GSES).Results (1) Males showed obviously higher level of SHAPS scores (24.91±5.14) and lower level of anticipatory pleasure of TEPS (TEPS-ANT) scores(31.81±5.79)than females (22.97±5.34 and 33.36±5.71,respectively).(2)Significant difference existed between the high-scoring,the middle-scoring and the low-scoring anhedonia group in TAS factor 1 (difficulty in identifying feelings) and GSES (F=3.11,5.30,P＜0.05 or 0.01),the scores of TAS factor 1 (difficulty in identifying feelings) in high-scoring anhedonia group were higher than that in low-scoring anhedonia group (20.24±4.94 vs 18.10±5.07,P＜0.01),and the scores of GSES in high-scoring anhedonia group were lower than that in low-scoring anhedonia group (24.97±6.72 vs 27.90±4.37,P＜0.01).(3)The SHAPS scores were positively related to TAS factor 2 (difficulty in describing feelings) and factor 3 (externally oriented thinking) (r =0.18,0.27,both P＜0.01),negatively related to GSES scores(r=-0.33,P＜0.01).Both TEPS-ANT and consummatory pleasure of TEPS (TEPS-CON) were negatively related to TAS factor1 (difficulty in identifying feelings)scores (r=-0.22,P＜ 0.01;r =-0.15,P＜ 0.05),positively related to GSES scores (r =0.28,0.26,both P＜0.01).(4)Layer multivariate linear regression analysis showed that the SHAPS scores were significant predictors of the general self-efficacy(β=-0.33,P＜0.01).Conclusions The anhedonia in college students has a closely relationship with alexithymia and self-efficacy,college students with high anhedonia have high level of alexithymia and low level of self-efficacy.

Objective To investigate perceptions of patient safety culture(PSC) among nurses in tertiary hospitals in Kunming. Methods Totally 2629 nurses were recruited by convenience sampling method from 7 tertiary hospi-tals in Kunming between July 2015 to January 2016. Hospital Survey on Patient Safety Culture (HSOPS) was used to assess PSC. Results The top three superior dimensions of PSC were Organizational Learning-Continuous Im-provement(86.60%),Teamwork within Hospital Units(83.34%) and Feedback and Communication about Error(75.98%). The last three inferior dimensions of PSC wereNonpunitive response to error(23.74%),Staffing(33.71%) and Teamwork across hospital units(49.45%). There were significant differences in certain items among nurses with different educational level,academic title,working hour per week(P<0.05). Conclusion Establishing nonpunitive re-sponse culture,reasonably arranging staffing and working hours,and encouraging nurses with high educational level and title to play their full role,are critical measures to improve patient safety culture in hospital.