Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study.

BACKGROUND: Previously published meta-epidemiological studies focused on Western medicine have identified some trial characteristics that impact the treatment effect of randomized controlled trials (RCTs). Nevertheless, it remains unclear if similar associations exist in RCTs on Chinese herbal medicine (CHM). Further, Chinese medicine-related characteristics have not been explored yet. OBJECTIVE: To investigate trial characteristics related to treatment effect estimates on CHM RCTs. SEARCH STRATEGY: This meta-epidemiological study searched 5 databases for systematic reviews on CHM treatment published between January 2011 and July 2021. INCLUSION CRITERIA: An eligible systematic review should only include RCTs of CHM and conduct at least one meta-analysis. DATA EXTRACTION AND ANALYSIS: Two reviewers independently conducted data extraction on general characteristics of systematic reviews, meta-analyses and included RCTs. They also assessed the risk of bias of RCTs using the Cochrane risk of bias tool. A two-step approach was used for data analyses. The ratio of odds ratios (ROR) and difference in standardized mean differences (dSMD) with 95% confidence interval (CI) were applied to present the difference in effect estimates for binary and continuous outcomes, respectively. RESULTS: Ninety-one systematic reviews, comprising 1338 RCTs were identified. For binary outcomes, RCTs incorporated with syndrome differentiation (ROR: 1.23; 95 % CI: [1.07, 1.39]), adopting Chinese medicine formula (ROR: 1.19; 95% CI: [1.03, 1.34]), with low risk of bias on incomplete outcome data (ROR: 1.29; 95% CI: [1.06, 1.52]) and selective outcome reporting (ROR: 1.12; 95% CI: [1.01, 1.24]), as well as a trial size ≥ 100 (ROR: 1.23; 95% CI: [1.04, 1.42]) preferred to show larger effect estimates. As for continuous outcomes, RCTs with Chinese medicine diagnostic criteria (dSMD: 0.23; 95% CI: [0.06, 0.41]), judged as high/unclear risk of bias on allocation concealment (dSMD: -0.70; 95% CI: [-0.99, -0.42]), with low risk of bias on incomplete outcome data (dSMD: 0.30; 95% CI: [0.18, 0.43]), conducted at a single center (dSMD: -0.33; 95% CI: [-0.61, -0.05]), not using intention-to-treat analysis (dSMD: -0.75; 95% CI: [-1.43, -0.07]), and without funding support (dSMD: -0.22; 95% CI: [-0.41, -0.02]) tended to show larger effect estimates. CONCLUSION: This study provides empirical evidence for the development of a specific critical appraisal tool for risk of bias assessments on CHM RCTs. Please cite this article as: Wang BH, Lin YL, Gao YY, Song JL, Qin L, Li LQ, et al. Trial characteristics and treatment effect estimates in randomized controlled trials of Chinese herbal medicine: A meta-epidemiological study. J Integr Med. 2024; Epub ahead of print.

Interaction of physical activity and low-level air pollution on cardiovascular disease: a prospective cohort study in UK Biobank.

To investigate the associations of physical activity (PA), low-level air pollution, and interaction on cardiovascular diseases (CVD) incidence based on the UK Biobank. PA was measured by the International Physical Activity Questionnaire and five air pollutants were estimated using Land Use Regression. All association estimates were based on Cox regression. Dose-response relationship was explored by restricted cubic spline, while multiplicative and additive interaction were examined by Pinteraction and relative excess risk due to interaction (RERI). As deviating proportional hazards assumption, we analyzed data as follow-up < 4 years and ≥ 4 years, separately. PA with 1000-4000 Metabolic Equivalent Task (MET) min/week showed the strongest protective impact on CVD incidence, while only low-level nitrogen dioxides (NO2) showed negative impact among five air pollutants and was considered for further analysis. Multiplicative interaction between PA and NO2 was observed during ≥ 4 years follow-up (Pinteraction = 0.049) while not during < 4 years (Pinteraction = 0.290). Positive additive interactions were found for high PA and low NO2 (< 20 µg/m3) group (RERI: 0.07, 95% confidence intervals: 0.02-0.11) during < 4 years, and for moderate PA with NO2 at 40- µg/m3 (0.07, 0.02-0.13) and < 20 µg/m3 (0.07, 0.02-0.12), while high PA showed similar results with NO2 at 40-, 20- and < 20 µg/m3 during ≥ 4 years. PA about 1000-4000 METs min/week showed the lowest CVD risk. Possibility of interaction with PA and NO2 is more likely to present with the increase in follow-up duration. We call for the optimal thresholds of PA, and exploring interaction thoroughly by considering types of PA.

Development and Validation of Knowledge Assessment Scales for Dementia and Urinary Incontinence in Community Older People.

To develop and validate scales for reliably assessing dementia and urinary incontinence knowledge of older adults in the community. Items were generated through a literature review, refined through a Delphi study (n = 19), and then revised through a pilot study (n = 29). Item analysis and exploratory factor analysis were applied to finalize the scales (n = 244). Construct validity, reliability, and acceptability were evaluated (n = 243). The two knowledge assessment scales for dementia and urinary incontinence, respectively, comprised 12 items and 8 items. Model fit indicators of both met the criteria of confirmatory factor analysis. Cronbach's α were .82 and .70, respectively. Completion ratio and completion time of the two scales was 83.51% and 4.22 ± 1.90 minutes. The knowledge assessment scales for dementia and urinary incontinence with satisfactory validity, reliability, and acceptability, could be served as valid tools for disease prevention and management among older adults in the community.

Immunological parameters of maternal peripheral blood as predictors of future pregnancy outcomes in patients with unexplained recurrent pregnancy loss.

INTRODUCTION: Unexplained recurrent pregnancy loss (URPL), affecting approximately 1%-5% of women, exhibits a strong association with various maternal factors, particularly immune disorders. However, accurately predicting pregnancy outcomes based on the complex interactions and synergistic effects of various immune parameters without an automated algorithm remains challenging. MATERIAL AND METHODS: In this historical cohort study, we analyzed the medical records of URPL patients treated at Xiangya Hospital, Changsha, China, between January 2020 and October 2022. The primary outcomes included clinical pregnancy and miscarriage. Predictors included complement, autoantibodies, peripheral lymphocytes, immunoglobulins, thromboelastography findings, and serum lipids. Least absolute shrinkage and selection operator (LASSO) analysis and logistic regression analysis was performed for model development. The model's performance, discriminatory, and clinical applicability were assessed using area under the curve (AUC), calibration curve, and decision curve analysis, respectively. Additionally, models were visualized by constructing dynamic and static nomograms. RESULTS: In total, 502 patients with URPL were enrolled, of whom 291 (58%) achieved clinical pregnancy and 211 (42%) experienced miscarriage. Notable differences in complement, peripheral lymphocytes, and serum lipids were observed between the two outcome groups. Moreover, URPL patients with elevated peripheral NK cells (absolute counts and proportion), decreased complement levels, and dyslipidemia demonstrated a significantly increased risk of miscarriage. Four models were developed in this study, of which Model 2 demonstrated superior performance with only seven predictors, achieving an AUC of 0.96 (95% CI: 0.93-0.99) and an accuracy of 0.92. A web-based platform was established to visually present model 2 and to facilitate its utilization by clinicians in outpatient settings (available from: https://yingrongli.shinyapps.io/liyingrong/). CONCLUSIONS: Our findings suggest that the implementation of such prediction models could serve as valuable tools for providing comprehensive information and facilitating clinicians in their decision-making processes.

Methodological quality of systematic reviews on sepsis treatments: A cross-sectional study.

OBJECTIVE: Systematic reviews (SRs) offer updated evidence to support decision-making on sepsis treatments. However, the rigour of SRs may vary, and methodological flaws may limit their validity in guiding clinical practice. This cross-sectional study appraised the methodological quality of SRs on sepsis treatments. METHODS: We searched MEDLINE, EMBASE, and Cochrane Database for eligible SRs on randomised controlled trials on sepsis treatments with at least one meta-analysis published between 2018 and 2023. We extracted SRs' bibliographical characteristics with a pre-designed form and appraised their methodological quality using AMSTAR (A MeaSurement Tool to Assess systematic Reviews) 2. We applied logistic regressions to explore associations between bibliographical characteristics and methodological quality ratings. RESULTS: Among the 102 SRs, two (2.0%) had high overall quality, while respectively four (3.9%), seven (6.9%) and 89 (87.3%) were of moderate, low, and critically low quality. Performance in several critical methodological domains was poor, with only 32 (31.4%) considering the risk of bias in primary studies in result interpretation, 22 (21.6%) explaining excluded primary studies, and 16 (15.7%) applying comprehensive searching strategies. SRs published in higher impact factor journals (adjusted odds ratio: 1.19; 95% confidence interval: 1.05 to 1.36) was associated with higher methodological quality. CONCLUSIONS: The methodological quality of recent SRs on sepsis treatments is unsatisfactory. Future reviewers should address the above critical methodological aspects. More resources should also be allocated to support continuous training in critical appraisal among healthcare professionals and other evidence users.

Development and validation of frailty and malnutrition knowledge assessment scale for community-dwelling older adults.

There is a lack of reliable tools to assess the knowledge of frailty and malnutrition in community-dwelling older adults. To develop and validate reliable frailty and malnutrition knowledge assessment scales for this population, two scales were developed and validated through five phases. Phase 1: the item pools were constructed through a literature review and research panel based on the symptom interpretation model. Phase 2: the expert consultation was performed to select the items. Phase 3: a pilot survey was conducted to assess the clarity of the items and further revise the scales. Phase 4: 242 older adults were surveyed to finalize the items. Phase 5: 241 older adults were surveyed to test the psychometric properties. The two scales each comprise 3 dimensions (symptoms, risk factors, and management strategies) and 11 items. They had good construct validity, with all indicators of correlation analysis and confirmatory factor analysis meeting their specific criteria. The reliability of the frailty and malnutrition knowledge assessment scales was good, with composite reliability coefficients all >0.60, Cronbach's alpha being 0.81 and 0.83, and the Spearman-Brown coefficient being 0.74 and 0.80, respectively. Their acceptability was good, with both having a completion rate of 92.18% and an average completion time of 3 min. The two scales are reliable tools to assess the knowledge of frailty and malnutrition among community-dwelling older adults, especially for large-scale surveys. They can help identify knowledge gaps in older adults and provide a basis for developing targeted educational interventions.

Medication Status and Related Factors in Essential Tremor Patients: A Cross-Sectional Study in China.

INTRODUCTION: Essential tremor (ET) is one of the most common movement disorders. Oral drugs play a crucial role in treating ET, with various available options such as propranolol, primidone, and topiramate. However, the medication status and related factors among Chinese ET patients are unknown yet. METHODS: This study used the baseline data from the National Survey of Essential Tremor Plus in China cohort. ET patients with information related to medication intake were included. Medication patients were defined as patients who were taking medication at the time of the survey. We further defined recommended medication users according to Chinese guideline recommendations and clinical knowledge. We used mean and standard deviation (SD), median and interquartile range (IQR), or frequencies and percentages when appropriate for descriptive analysis. We used multivariate logistic regression analyses to explore factors related to medication intake in all ET patients and in recommended medication users. RESULTS: Of 1,153 included ET participants, 207 (18.0%) took medication. Arotinolol (115, 55.6%) and propranolol (63, 30.4%) were the top 2 used medicines. Patients with middle school education (odds ratio 0.57, 95% confidence interval 0.39-0.83), college or higher level education (0.46, 0.28-0.76), and late-onset ET (LO-ET) (0.38, 0.23-0.63) were less likely to take medication. Patients with intention tremor (1.90, 1.38-2.62), every 10-unit increase in age (1.10, 1.00-1.21), Tremor Research Group Essential Tremor Rating Assessment Scale (TETRAS) Part 1 (1.63, 1.37-1.93), and TETRAS Part 2 (1.81, 1.48-2.22) were more likely to take medication. Among 332 recommended medication users, only 104 (31.3%) took medicine. The associations of LO-ET (0.36, 0.17-0.75), intention tremor (2.27, 1.35-3.81), TETRAS Part 1 (1.52, 1.09-2.13), and TETRAS Part 2 (1.59, 1.15-2.20) with medication were similar to all ET patients. CONCLUSION: The proportion of medication intake is low among both all ET patients and recommended medication users. The top 2 commonly used medications among all ET patients are arotinolol and propranolol. Influencing factors of medication intake are different between all ET patients and recommended medication users. Clinicians are suggested to provide counseling and education on ET medication to promote medication intake.

Initial low-dose computed tomography screening results and summary of participant characteristics: based on the latest Chinese guideline.

Background: Low-dose computed tomography (LDCT) has been promoted as a promising screening strategy for early detection of lung cancer. China released the latest lung cancer screening guideline in 2021. The compliance of the individuals who received LDCT for lung cancer screening with the guideline is unknown yet. It is necessary to summarize the distribution of guideline-defined lung cancer-related risk factors in the Chinese population so as to inform the selection of target population for the future lung cancer screening. Methods: A single-center, cross-sectional study design was adopted. All participants were individuals who underwent LDCT at a tertiary teaching hospital in Hunan, China, between 1 January and 31 December 2021. LDCT results were derived along with guideline-based characteristics for descriptive analysis. Results: A total of 5,486 participants were included. Over one-quarter (1,426, 26.0%) of the participants who received screening did not meet the guideline-defined high-risk population, even among non-smokers (36.4%). Most of the participants (4,622, 84.3%) were found to have lung nodules, while no clinical intervention was required basically. The detection rate of positive nodules varied from 46.8% to 71.2% when using different cut-off values for positive nodules. Among non-smoking women, ground glass opacity appeared to be more significantly common compared with non-smoking men (26.7% vs. 21.8%). Conclusion: Over one-quarter of individuals who received LDCT screening did not meet the guideline-defined high-risk populations. Appropriate cut-off values for positive nodules need to be continuously explored. More precise and localized criteria for high-risk individuals are needed, especially for non-smoking women.

Long-term exposure to ambient air pollutants and their interaction with physical activity on insomnia: A prospective cohort study.

Exposure to air pollution or lack of physical activity (PA) increases the risk of insomnia. However, evidence on joint exposure to air pollutants is limited, and the interaction of joint air pollutants and PA on insomnia is unknown. This prospective cohort study included 40,315 participants with related data from the UK Biobank, which recruited participants from 2006 to 2010. Insomnia was assessed by self-reported symptoms. The annual average air pollutant concentrations of particulate matter (PM2.5, PM10), nitrogen oxides (NO2, NOX), sulfur dioxide (SO2) and carbon monoxide (CO) were calculated based on participants' addresses. We applied a weighted Cox regression model to evaluate the correlation between air pollutants and insomnia and newly proposed an air pollution score to assess joint air pollutants effect using a weighted concentration summation after obtaining the weights of each pollutant in the Weighted-quantile sum regression. With a median follow-up of 8.7 years, 8511 participants developed insomnia. For each 10 µg/m³ increase in NO2, NOX, PM10, SO2, the average hazard ratios (AHRs) and 95% confidence interval (CI) of insomnia were 1.10 (1.06, 1.14), 1.06 (1.04, 1.08), 1.35 (1.25, 1.45) and 2.58 (2.31, 2.89), respectively; For each 5 µg/m³ increase in PM2.5 and each 1 mg/m³ increase in CO, the corresponding AHRs (95%CI) were 1.27 (1.21, 1.34) and 1.83 (1.10, 3.04), respectively. The AHR (95%CI) for insomnia associated with per interquartile range (IQR) increase in air pollution scores were 1.20 (1.15, 1.23). In addition, potential interactions were examined by setting cross-product terms of air pollution score with PA in the models. We observed an interaction between air pollution scores and PA (P = 0.032). The associations between joint air pollutants and insomnia were attenuated among participants with higher PA. Our study provides evidence on developing strategies for improving healthy sleep by promoting PA and reducing air pollution.

Comparative effectiveness of non-pharmacological interventions for frailty: a systematic review and network meta-analysis.

BACKGROUND: Frailty endangers the health of older adults. Furthermore, the prevalence of frailty continues to increase as the global population ageing. OBJECTIVE: To update evidence on the effectiveness of non-pharmacological interventions for frailty by conducting a network meta-analysis (NMA) of randomised controlled trials (RCTs). METHODS: Eight databases were searched from January 1, 2000, until September 24, 2021. RCTs of interventions for frailty among participants aged ≥60 years were considered eligible. The primary outcome was frailty. Pairwise meta-analysis and NMA were performed, with the pooled standardised mean difference (SMD) and 95% confidence interval (CI) being reported. RESULTS: A total of 69 RCTs were included after screening 16,058 retrieved citations. There were seven types of interventions (11 interventions) for frailty among the included RCTs. Physical activity (PA) (pooled SMD = 0.43, 95% CI: 0.34-0.51), multicomponent intervention (pooled SMD = 0.34, 95% CI: 0.23-0.45) and nutrition intervention (pooled SMD = 0.21, 95% CI: 0.06-0.35) were associated with reducing frailty compared to control, of which PA was the most effective type of intervention. In terms of specific types of PA, resistance training (pooled SMD = 0.58, 95% CI: 0.33-0.83), mind-body exercise (pooled SMD = 0.57, 95% CI: 0.24-0.90), mixed physical training (pooled SMD = 0.47, 95% CI: 0.37-0.57) and aerobic training (pooled SMD = 0.36, 95% CI: 0.09-0.62) were associated with a reduction in frailty compared to usual care. Resistance training was the most effective PA intervention. CONCLUSION: Resistance training has the best potential to reduce frailty in older adults. This finding might be useful to clinicians in selecting interventions for older adults with frailty.

Lifestyle trajectories and ischaemic heart diseases: a prospective cohort study in UK Biobank.

AIMS: To evaluate the associations of baseline and long-term trajectories of lifestyle with incident ischaemic heart diseases (IHDs). METHODS AND RESULTS: 29 164 participants in the UK Biobank who had at least one follow-up assessment and were free of IHD at the last follow-up assessment were included. We constructed a weighted unhealthy lifestyle score though summing five lifestyle factors [smoking, physical activity, diet, body mass index, and sleep duration]. Lifestyle assessed at baseline (2006-09), the first follow-up assessment (2012-13), and the second follow-up assessment (since 2014) were used to derive the trajectories of each individual. The joint categories were created through cross-classifying the three baseline lifestyle categories (ideal, intermediate, and poor) by the three lifestyle trajectory categories (improve, maintain, and decline). During a median follow-up period of 4.2 years, 868 IHD events were recorded. The hazard ratio (HR) of incident IHD associated with per unit increase in unhealthy lifestyle trajectory was 1.08 [95% confidence interval (CI): 0.99-1.17]. Subgroup analyses indicated such association was stronger among individuals with hypertension (HR: 1.13, 95% CI: 1.03-1.24), diabetes (HR: 1.23, 95% CI: 0.96-1.58), or hyperlipidaemia (HR: 1.09, 95% CI: 0.97-1.22). Compared with participants consistently adhering to an ideal lifestyle (ideal-maintain), the HRs of incident IHD were 1.30 (1.07-1.58) for intermediate-maintain, 1.52 (1.23-1.88) for poor-maintain, 1.25 (0.93-1.68) for intermedia-improve, 1.48 (1.17-1.88) for poor-improve, 1.46 (1.08-1.99) for intermedia-decline, and 1.77 (1.21-2.59) for poor-decline. CONCLUSIONS: A declined lifestyle trajectory increased the risk of incident IHD, irrespective of baseline lifestyle levels. Individuals with hypertension, diabetes, or hyperlipidaemia were more predisposed to the influence of lifestyle change.

It is known that an unhealthy lifestyle at baseline was associated with an increased risk of cardiovascular diseases (CVDs), but the risk attributed to the lifestyle changes (or trajectories) over the long term has not been well quantified. Meanwhile, the effects of lifestyle, either in baseline level or trajectories, on different CVD subtypes such as ischaemic heart diseases (IHDs) and stroke varied. Thus, this study used the data from UK Biobank to construct a weighted unhealthy lifestyle score and to evaluate the prospective associations of baseline and long-term trajectories of the unhealthy lifestyle score with the risk of incident IHD. A total of 352 251 and 29 164 participants were included in the unhealthy lifestyle construction and lifestyle trajectory analysis, respectively. We found a poorer lifestyle at baseline was significantly associated with an increased risk of incident IHD in a linear dose­response fashion. Besides, a declined lifestyle trajectory was associated with an increased risk of incident IHD, irrespective of baseline lifestyle levels, and such an association was stronger among individuals with hypertension, diabetes, or hyperlipidaemia. Compared with the maintainers, risks of incident IHD attenuated when individuals improved their lifestyle and strengthened when declined their lifestyle.A declined lifestyle trajectory increased the risk of incident IHD, irrespective of baseline lifestyle levels. Such association was stronger among participants with hypertension, diabetes, or hyperlipidaemia.Compared with the maintainers of lifestyle, risks of incident IHD attenuated when individuals improved their lifestyle and strengthened when declined their lifestyle.

Predictive models for the incidence of Parkinson's disease: systematic review and critical appraisal.

Numerous predictive models for Parkinson's disease (PD) incidence have been published recently. However, the model performance and methodological quality of those available models are yet needed to be summarized and assessed systematically. In this systematic review, we systematically reviewed the published predictive models for PD incidence and assessed their risk of bias and applicability. Three international databases were searched. Cohort or nested case-control studies that aimed to develop or validate a predictive model for PD incidence were considered eligible. The Prediction model Risk Of Bias ASsessment Tool (PROBAST) was used for risk of bias and applicability assessment. Ten studies covering 10 predictive models were included. Among them, four studies focused on model development, covering eight models, while the remaining six studies focused on model external validation, covering two models. The discrimination of the eight new development models was generally poor, with only one model reported C index > 0.70. Four out of the six external validation studies showed excellent or outstanding discrimination. All included studies had high risk of bias. Three predictive models (the International Parkinson and Movement Disorder Society [MDS] prodromal PD criteria, the model developed by Karabayir et al. and models validated by Faust et al.) are recommended for clinical application by considering model performance and resource-demanding. In conclusion, the performance and methodological quality of most of the identified predictive models for PD incidence were unsatisfactory. The MDS prodromal PD criteria, model developed by Karabayir et al. and model validated by Faust et al. may be considered for clinical use.

Comparing diagnostic performance of Cantonese-Chinese version of Rome IV criteria and a short Reference Standard for functional dyspepsia in China.

INTRODUCTION: Functional dyspepsia (FD) is diagnosed based on self-reported symptoms and negative upper gastrointestinal endoscopic findings. The Rome criteria were not adopted as a diagnostic instrument in clinical guidelines due to their complexity. Different guidelines used relatively simple symptom assessment schemes with contents that vary significantly. A previously evaluated short Reference Standard may serve as a more standardised tool for guidelines. We evaluated its diagnostic accuracy against the Rome IV criteria in a cross-sectional study in Hong Kong. METHODS: A total of 220 dyspeptic patients sampled consecutively from a tertiary hospital and the community completed the Rome IV diagnostic questionnaire, which was translated into Cantonese-Chinese, and the Reference Standard. Sensitivity, specificity, positive and negative likelihood ratios (LRs), and area under the receiver operating characteristics curve (AUC), with 95% confidence intervals (CIs), were calculated. RESULTS: Among the participants, 160 (72.7%) fulfilled the Reference Standard with negative upper gastrointestinal endoscopic results. The Reference Standard identified patients with Rome IV-defined FD with 91.1% (95% CI 82.6%-96.4%) sensitivity and 37.6% (95% CI 29.6%-46.1%) specificity. The positive and negative LRs were 1.46 (95% CI 1.26-1.69) and 0.24 (95% CI 0.11-0.49), respectively. The AUC value was 0.64 (95% CI 0.59-0.69). CONCLUSIONS: The Reference Standard can rule out patients without Rome IV-defined FD. It may be used as an initial screening tool for FD in settings where the use of the Rome IV criteria is impractical. It may also provide a uniform definition and diagnostic rule for future updates of clinical guidelines.

Methodological quality of systematic reviews on treatments for Alzheimer's disease: a cross-sectional study.

BACKGROUND: Carefully conducted systematic reviews (SRs) can provide reliable evidence on the effectiveness of treatment strategies for Alzheimer's disease (AD). Nevertheless, the reliability of SR results can be limited by methodological flaws. This cross-sectional study aimed to examine the methodological quality of SRs on AD treatments, along with potentially relevant factors. METHODS: To identify eligible SRs on AD treatments, four databases including the Cochrane Database of Systematic Reviews, MEDLINE, EMBASE, and PsycINFO were searched. The Assessing the Methodological Quality of Systematic Reviews 2 instrument was used for quality appraisal of SRs. Multivariable regression analyses were used to examine factors related to methodological quality. RESULTS: A total of 102 SRs were appraised. Four (3.90%) SRs were considered as high quality; 14 (13.7%), 48 (47.1%), and 36 (35.3%) were as moderate, low, and critically low quality, respectively. The following significant methodological limitations were identified: only 22.5% of SRs registered protocols a priori, 6.9% discussed the rationales of chosen study designs, 21.6% gave a list of excluded studies with reasons, and 23.5% documented funding sources of primary studies. Cochrane SRs (adjusted odds ratio (AOR): 31.9, 95% confidence interval (CI): 3.81-266.9) and SRs of pharmacological treatments (AOR: 3.96, 95%CI: 1.27-12.3) were related to the higher overall methodological quality of SRs. CONCLUSION: Methodological quality of SRs on AD treatments is unsatisfactory, especially among non-Cochrane SRs and SRs of non-pharmacological interventions. Improvement in the following methodological domains requires particular attention due to poor performance: registering and publishing protocols a priori, justifying study design selection, providing a list of excluded studies, and reporting funding sources of primary studies.

Quantification of prevalence, clinical characteristics, co-existence, and geographic variations of traditional Chinese medicine diagnostic patterns via latent tree analysis-based differentiation rules among functional dyspepsia patients.

BACKGROUND: Traditional Chinese Medicine (TCM) treatment strategies are guided by pattern differentiation, as documented in the eleventh edition of the International Classification of Diseases (ICD). However, no standards for pattern differentiation are proposed to ensure inter-rater agreement. Without standardisation, research on associations between TCM diagnostic patterns, clinical features, and geographical characteristics is also not feasible. This diagnostic cross-sectional study aimed to (i) establish the pattern differentiation rules of functional dyspepsia (FD) using latent tree analysis (LTA); (ii) compare the prevalence of diagnostic patterns in Hong Kong and Hunan; (iii) discover the co-existence of diagnostic patterns; and (iv) reveal the associations between diagnostic patterns and FD common comorbidities. METHODS: A total of 250 and 150 participants with FD consecutively sampled in Hong Kong and Hunan, respectively, completed a questionnaire on TCM clinical features. LTA was performed to reveal TCM diagnostic patterns of FD and derive relevant pattern differentiation rules. Multivariate regression analyses were performed to quantify correlations between different diagnostic patterns and between diagnostic patterns and clinical and geographical variables. RESULTS: At least one TCM diagnostic pattern was differentiated in 70.7%, 73.6%, and 64.0% of the participants in the overall (n = 400), Hong Kong (n = 250), and Hunan (n = 150) samples, respectively, using the eight pattern differentiation rules derived. 52.7% to 59.6% of the participants were diagnosed with two or more diagnostic patterns. Cold-heat complex (59.8%) and spleen-stomach dampness-heat (77.1%) were the most prevalent diagnostic patterns in Hong Kong and Hunan, respectively. Spleen-stomach deficiency cold was highly likely to co-exist with spleen-stomach qi deficiency (adjusted odds ratio (AOR): 53.23; 95% confidence interval (CI): 21.77 to 130.16). Participants with severe anxiety tended to have liver qi invading the stomach (AOR: 1.20; 95% CI: 1.08 to 1.33). CONCLUSIONS: Future updates of the ICD, textbooks, and guidelines should emphasise the importance of clinical and geographical variations in TCM diagnosis. Location-specific pattern differentiation rules should be derived from local data using LTA. In future, patients' pattern differentiation results, local prevalence of TCM diagnostic patterns, and corresponding TCM treatment choices should be accessible to practitioners on online clinical decision support systems to streamline service delivery.

Characteristics and Quality of Diagnostic and Risk Prediction Models for Frailty in Older Adults: A Systematic Review.

Several prediction models for frailty in older adults have been published, but their characteristics and methodological quality are unclear. This review aims to summarize and critically appraise the prediction models. Studies describing multivariable prediction models for frailty among older adults were included. PubMed, Embase, Web of Science, and PsycINFO were searched from outset to Feb 21, 2021. Methodological and reporting quality of included models were evaluated by PROBAST and TRIPOD, respectively. All results were descriptively summarized. Twenty articles including 39 models were identified. The included models showed good predictive discrimination with C indices ranging from 0.70 to 0.98. However, all studies except one were assessed as high risk of bias mainly due to inappropriate analysis; meanwhile, poor reporting quality was also frequently observed. Few mature prediction models can be used in practice. Researchers should pay more attention to external validation and improving the quality both in methodology and reporting.

Effectiveness and acceptability of non-pharmacological interventions in people with mild cognitive impairment: Overview of systematic reviews and network meta-analysis.

BACKGROUND: To explore effectiveness and acceptability of non-pharmacological interventions in mild cognitive impairment (MCI). METHODS: Overview of systematic reviews and network meta-analysis were conducted. Systematic reviews (SRs) were searched via seven databases from June 2015 to June 2020. Randomized controlled trials (RCTs) were retrieved. The Methodological quality was assessed by AMSTAR 2 and RoB 2. Outcomes were effectiveness and acceptability measured by standardized mean differences (SMDs) and odd ratios (ORs) with 95% confidence interval (CI). Pairwise meta-analysis was first conducted, followed by network meta-analysis. RESULTS: A total of 22 SRs and 42 RCTs with 4401 participants were included. The methodological quality of included SRs and RCTs were moderate. There were four interventions, with three types of physical activity (aerobic, muscle-strengthening, and mind-body), three types of cognitive (rehearsal-based, compensatory, and mixed), multicomponent (physical and cognitive component), and nutrition intervention. No significant inconsistency was identified. Regarding intervention effectiveness, muscle-strengthening (SMDs 0.87, 95% CI 0.31-1.43; rank 1), mind-body (0.76, 0.38-1.14; rank 2) and aerobic (0.34, 0.13-0.50; rank 3) were significantly better than the control group and there was no significant difference among these types of intervention . Cognitive intervention of rehearsal-based (1.33, 0.30-2.35; rank 1) and mixed (0.55, 0.00-1.11; rank 2) were significantly better than the control group and there was no significant difference among these types of intervention. Multicomponent intervention (0.32, 0.02-0.62) were significantly better than the control group but not better than the single component group. Regarding acceptability, there was no significant difference among types of intervention. CONCLUSION: Physical activity, cognitive, and multicomponent intervention could be provided regardless of their types and acceptability due to their effectiveness on improved cognitive function for people with MCI.

Methodological quality of systematic reviews on Chinese herbal medicine: a methodological survey.

BACKGROUND: Systematic reviews (SRs) synthesise the best evidence of effectiveness and safety on Chinese herbal medicine (CHM). Decision-making should be supported by the high-quality evidence of prudently conducted SRs, but the trustworthiness of conclusions may be limited by poor methodological rigour. METHODS: This survey aimed to examine the methodological quality of a representative sample of SRs on CHM published during January 2018 to March 2020. We conducted literature search in Cochrane Database of Systematic Reviews, MEDLINE via Ovid, and EMBASE via Ovid. Eligible SRs must be in Chinese or English with at least one meta-analysis on the treatment effect of any CHM documented in the 2015 Chinese Pharmacopoeia. Two reviewers extracted the bibliographical characteristics of SRs and appraised their methodological quality using AMSTAR 2 (Assessing the Methodological Quality of Systematic Reviews 2). The associations between bibliographical characteristics and methodological quality were investigated using Kruskal-Wallis tests and Spearman's rank correlation coefficients. RESULTS: We sampled and appraised one hundred forty-eight SRs. Overall, one (0.7%) was of high methodological quality; zero (0%), four (2.7%), and one-hundred forty-three (96.6%) SRs were of moderate, low, and critically-low quality. Only thirteen SRs (8.8%) provided a pre-defined protocol; none (0%) provided justifications for including particular primary study designs; six (4.1%) conducted a comprehensive literature search; two (1.4%) provided a list of excluded studies; nine (6.1%) undertook meta-analysis with appropriate methods; and seven (4.7%) reported funding sources of included primary studies. Cochrane reviews had higher overall quality than non-Cochrane reviews (P < 0.001). SRs with European funding support were less likely to have critically-low quality when compared with their counterparts (P = 0.020). SRs conducted by more authors (rs = 0.23; P = 0.006) and published in higher impact factor journals (rs = 0.20; P = 0.044) were associated with higher methodological quality. CONCLUSIONS: Our results indicated that the methodological quality of SRs on CHM is low. Future authors should enhance the methodological quality through registering a priori protocols, justifying selection of study designs, conducting comprehensive literature search, providing a list of excluded studies with rationales, using appropriate method for meta-analyses, and reporting funding sources among primary studies.

Chinese herbal medicine for functional dyspepsia: a network meta-analysis of prokinetic-controlled randomised trials.

BACKGROUND: Prokinetic is the first-line conventional treatment for functional dyspepsia (FD) in Asia despite potential adverse events. Chinese herbal medicine (CHM) may be an effective and safe substitution. This network meta-analysis (NMA) aimed to evaluate the comparative effectiveness of different CHM formulae for FD against prokinetics. METHODS: Seven international and Chinese databases were searched from their inception to July 2020 for randomised controlled trials (RCTs) on CHM versus prokinetics. Data from each RCT were first pooled using random-effect pairwise meta-analyses and illustrated as risk difference (RD) or standardised mean difference (SMD) with 95% confidence interval (CI). Random-effect NMAs were then performed to evaluate the comparative effectiveness of CHM formulae and displayed as RD with 95% CI or SMD with 95% credible interval (CrI). The GRADE partially contextualised framework was applied for NMA result interpretation. RESULTS: Twenty-six unique CHM formulae were identified from twenty-eight RCTs of mediocre quality. Pairwise meta-analyses indicated that CHM was superior to prokinetics in alleviating global symptoms at 4-week follow-up (pooled RD: 0.14; 95% CI: 0.10-0.19), even after trim and fill adjustment for publication bias. NMAs demonstrated that Modified Zhi Zhu Decoction may have a moderate beneficial effect on alleviating global symptoms at 4-week follow-up (RD: 0.28; 95% CI: - 0.03 to 0.75). Xiao Pi Kuan Wei Decoction may have a large beneficial effect on alleviating postprandial fullness (SMD: - 2.14; 95% CI: - 2.76 to 0.70), early satiety (SMD: - 3.90; 95% CI: - 0.68 to - 0.42), and epigastric pain (SMD: - 1.23; 95% CI: - 1.66 to - 0.29). No serious adverse events were reported. CONCLUSION: Modified Zhi Zhu Decoction and Xiao Pi Kuan Wei Decoction may be considered as an alternative for patients unresponsive to prokinetics. Confirmatory head-to-head trials should be conducted to investigate their comparative effectiveness against prokinetics.