Equity issues rarely addressed in the development of COVID-19 formal recommendations and good practice statements: a cross-sectional study.

BACKGROUND AND OBJECTIVE: To identify COVID-19 actionable statements (e.g., recommendations) focused on specific disadvantaged populations in the living map of COVID-19 recommendations (eCOVIDRecMap) and describe how health equity was assessed in the development of the formal recommendations. METHODS: We employed the place of residence, race or ethnicity or culture, occupation, gender or sex, religion, education, socio-economic status, and social capital-Plus framework to identify statements focused on specific disadvantaged populations. We assessed health equity considerations in the evidence to decision frameworks (EtD) of formal recommendations for certainty of evidence and impact on health equity criteria according to the Grading of Recommendations, Assessment, Development, and Evaluations criteria. RESULTS: We identified 16% (124/758) formal recommendations and 24% (186/819) good practice statements (GPS) that were focused on specific disadvantaged populations. Formal recommendations (40%, 50/124) and GPS (25%, 47/186) most frequently focused on children. Seventy-six percent (94/124) of the recommendations were accompanied with EtDs. Over half (55%, 52/94) of those considered indirectness of the evidence for disadvantaged populations. Considerations in impact on health equity criterion most frequently involved implementation of the recommendation for disadvantaged populations (17%, 16/94). CONCLUSION: Equity issues were rarely explicitly considered in the development COVID-19 formal recommendations focused on specific disadvantaged populations. Guidance is needed to support the consideration of health equity in guideline development during health emergencies.

Using Deep Neural Network Approach for Multiple-Class Assessment of Digital Mammography.

According to the Health Promotion Administration in the Ministry of Health and Welfare statistics in Taiwan, over ten thousand women have breast cancer every year. Mammography is widely used to detect breast cancer. However, it is limited by the operator's technique, the cooperation of the subjects, and the subjective interpretation by the physician. It results in inconsistent identification. Therefore, this study explores the use of a deep neural network algorithm for the classification of mammography images. In the experimental design, a retrospective study was used to collect imaging data from actual clinical cases. The mammography images were collected and classified according to the breast image reporting and data-analyzing system (BI-RADS). In terms of model building, a fully convolutional dense connection network (FC-DCN) is used for the network backbone. All the images were obtained through image preprocessing, a data augmentation method, and transfer learning technology to build a mammography image classification model. The research results show the model's accuracy, sensitivity, and specificity were 86.37%, 100%, and 72.73%, respectively. Based on the FC-DCN model framework, it can effectively reduce the number of training parameters and successfully obtain a reasonable image classification model for mammography.

[Cross-scale spatiotemporal characteristics of landscape ecological conditions index in coastal zone of Jiangsu Province, China during 1990-2020.] / 1990­2020年江苏省海岸带景观生态状况指数跨尺度时空特征.

Coastal zone ecosystems in Jiangsu have produced different degrees of spatial response and degradation characteristics under complex external disturbances, especially significant spatiotemporal evolution of landscape pattern in recent decades. It is urgent to carry out comprehensive assessment on landscape ecology covering landscape composition, configuration, and function at multiple scales. We analyzed the spatial and temporal variations of landscape ecological condition index (LECI) in large-scale coastal zone of Jiangsu Province from 1990 to 2020, assessed landscape ecological conditions of 14 county-level districts, and selected evaluation units with side lengths of 100, 200,…, 1000 m to understand the spatial scale effects of LECI. The results showed that the indicators of landscape composition, configuration and function could sensitively reflect the changes of LECI, which could comprehensively evaluate landscape ecological condition of Jiangsu coastal zone during the study period, with 300 m evaluation unit being the best spatial scale. The LECI value in the study area fluctuated. Landscape ecological condition was the best in 1990 and the worst in 2020. Landscape composition and configuration had a greater impacts on the changes of landscape ecological condition. The fluctuation of LECI in different counties and cities was closely related to intense human activities. Human activities, such as industrial development and urban expansion, had damaged landscape ecological status. The establishment of nature reserves had restored landscape ecological status to a certain extent. LECI could effectively indicate the changes of landscape ecological status of large-scale coastal zone, and provide multi-perspective suggestions for space utilization and protection.

Island development suitability evaluation for supporting the spatial planning in archipelagic areas.

The study of island development suitability can provide important reference for island ecosystem-based management and sustainable development, as well as technical foundation for land development suitability evaluation and spatial planning in other areas. In this study, two typical China's archipelagos, namely, Miaodao Archipelago and Dongtou Archipelago, were selected to demonstrate the study. The carrying capacities of the three major development types, that is, ecological conservation, agricultural production, and urban construction, served as basic data; the controlling factors of island development suitability were identified in aspects of terrain, sea, and soil, and their influences on the three development types were separately measured in the two archipelagos and on different types of islands; and the island development suitability index (IDSI) was established for each of the three development types. Then, four schemes, namely, Schemes A-D, were designed based on the IDSIs and for purposes of free development, ecological conservation, agricultural production, and coordinated development, respectively, to conduct the island functional zoning, and the optimum scheme was finally selected. The results indicated that the influence natures and degrees of controlling factors showed distinct spatial heterogeneities across different archipelagos and across different types of islands within the same archipelago. Area proportions of the planned zones varied in different schemes for different purposes, and the optimum scheme was generated by assigning Schemes A, B, C, and D to the reclamation areas within the islands, the uninhabited islands, the sandy island, and the remaining islands, respectively. The present study validated two hypotheses: First, the factual influences of controlling factors on the land development suitability varied across different areas and might not be in accordance with the empirical cognitions. Second, the method of multiple schemes for different development purposes could contribute to solving the problem of disconnection of land development suitability with spatial planning.

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial. OBJECTIVE: The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care. METHODS: The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4-percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention. RESULTS: The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024. CONCLUSIONS: This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32918.

Use of ICD-10-CM T codes in hospital claims data to identify adverse drug events in Taiwan.

WHAT IS KNOWN AND OBJECTIVE: Adverse drug events (ADEs) are a major public health concern worldwide and may prolong hospital stays, causing a burden on the healthcare system and increasing the associated costs. Therefore, optimizing medication use and reducing ADEs are priorities for public health. Medication safety can be monitored and improved by identifying ADEs. The utilization of diagnoses coded according to the International Statistical Classification of Diseases and Related Health Problems (ICD) system for the identification of ADEs has been firmly established. In Taiwan, however, the validity of recording ADEs on the basis of inpatient ICD-10-CM T codes has not been evaluated. Therefore, this study investigated the potential usefulness of ICD-10-CM T codes in routine hospital data for the identification of ADEs and for increasing the rate of reporting. METHODS: We use hospital claims data of hospitalized patients from one medical centre in northern Taiwan between 1 July 2016 and 30 June 2018. We defined an ADE to have taken place if an ICD-10-CM T code was present among the primary or secondary diagnosis codes. The inpatients who were discharged with T codes in a primary or secondary diagnosis were identified by the computerized T code information platform, and the retrospective review of the medical charts was performed by pharmacists to confirm the ADEs. RESULTS AND DISCUSSION: 1384 inpatients who were discharged with the relevant T codes in a primary or secondary diagnosis were identified during the study period. Code T36 (poisoning by, adverse effect of or underdosing of systemic antibiotics) was the most common code, accounting for 56.6%, followed by T42 (17.7%; poisoning by, adverse effect of or underdosing of antiepileptic, sedative-hypnotic or antiparkinsonism drug). Overall, 789 clinically significant ADEs were identified after medical chart review. The dermatologic system was the most commonly involved. The overall positive predictive value for a flagged code representing an ADE was 57%. Furthermore, the use of T codes to confirm the number of ADE cases increased the ADE reporting rate by 9.17%. WHAT IS NEW AND CONCLUSION: The PPV of ICD-10-CM T codes analysed in our study was insufficient for identifying ADEs during hospitalization. The sensitivity and specificity of this were inadequate. However, the T code system can be used as an auxiliary resource for pharmacists to identify potential ADEs and report the information as prompts on the physician order entry system. When a physician prescribes a drug that may cause an ADE in a patient, an alert is issued to ensure medication safety. In conclusion, the T codes did not perform well in our study and caution should be exercised in their use to identify ADEs on their own.

Periodontitis and the subsequent risk of glaucoma: results from the real-world practice.

Periodontitis is a multifactorial inflammatory disease that can cause tooth loss and contribute to systemic inflammation. It is suggested that periodontitis may be associated with the development of glaucoma. Based on data from Taiwan's National Health Insurance Research Database, a retrospective cohort study was conducted to investigate the risk of developing glaucoma in patients with periodontitis. The periodontitis cohort consisted of newly diagnosed adult patients (n = 194,090, minimum age = 20 years) between 2000 and 2012. The comparison group included age-, gender-, and diagnosis date-matched people without periodontitis (n = 194,090, minimum age = 20 years). Incident glaucoma was monitored until the end of 2013. Hazard ratios (HRs) with confidence intervals (CIs) were established based on the Cox proportional hazard models. The risk of developing glaucoma was higher in patients with periodontitis than those without periodontitis (31.2 vs. 23.3 patients per 10,000 person-years, with an adjusted HR of 1.26 [95% CI 1.21-1.32]). A high risk was evident even after stratifying by age (adjusted HRs = 1.34 [1.26-1.44] for ages 20-49, 1.24 [1.13-1.36] for ages ≥ 65, and 1.20 [1.12-1.29] for ages 50-64 years), sex (adjusted HRs = 1.33 [1.24-1.41] and 1.21 [1.14-1.28] for men and women, respectively), presence of comorbidity (adjusted HRs = 1.38 [1.29-1.47] and 1.18 [1.12-1.25] for without and with comorbidity, respectively), and corticosteroid use (adjusted HRs = 1.27 [1.21-1.33] and 1.21 [1.08-1.35] for without and with corticosteroid use, respectively). Specifically, patients with periodontitis exhibited a significantly high risk of primary open-angle glaucoma (adjusted HR = 1.31 [1.21-1.32]) but not for primary closed-angle glaucoma (adjusted HR = 1.05 [0.94-1.17]). People with periodontitis are at a greater risk of glaucoma than individuals without periodontitis. Ocular health should be emphasized for such patients, and the underlying mechanisms need further investigation.

Post-Acute Kidney Injury Proteinuria and Subsequent Kidney Disease Progression: The Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury (ASSESS-AKI) Study.

Importance: Among patients who had acute kidney injury (AKI) during hospitalization, there is a need to improve risk prediction such that those at highest risk for subsequent loss of kidney function are identified for appropriate follow-up. Objective: To evaluate the association of post-AKI proteinuria with increased risk of future loss of renal function. Design, Setting, and Participants: The Assessment, Serial Evaluation, and Subsequent Sequelae in Acute Kidney Injury (ASSESS-AKI) Study was a multicenter prospective cohort study including 4 clinical centers in North America included 1538 patients enrolled 3 months after hospital discharge between December 2009 and February 2015. Exposures: Urine albumin-to-creatinine ratio (ACR) quantified 3 months after hospital discharge. Main Outcomes and Measures: Kidney disease progression defined as halving of estimated glomerular filtration rate (eGFR) or end-stage renal disease. Results: Of the 1538 participants, 769 (50%) had AKI durring hospitalization. The baseline study visit took place at a mean (SD) 91 (23) days after discharge. The mean (SD) age was 65 (13) years; the median eGFR was 68 mL/min/1.73 m2; and the median urine ACR was 15 mg/g. Overall, 547 (37%) study participants were women and 195 (13%) were black. After a median follow-up of 4.7 years, 138 (9%) participants had kidney disease progression. Higher post-AKI urine ACR level was associated with increased risk of kidney disease progression (hazard ratio [HR], 1.53 for each doubling; 95% CI, 1.45-1.62), and urine ACR measurement was a strong discriminator for future kidney disease progression (C statistic, 0.82). The performance of urine ACR was stronger in patients who had had AKI than in those who had not (C statistic, 0.70). A comprehensive model of clinical risk factors (eGFR, blood pressure, and demographics) including ACR provided better discrimination for predicting kidney disease progression after hospital discharge among those who had had AKI (C statistic, 0.85) vs those who had not (C statistic, 0.76). In the entire matched cohort, after taking into account urine ACR, eGFR, demographics, and traditional chronic kidney risk factors determined 3 months after discharge, AKI (HR, 1.46; 95% CI, 0.51-4.13 for AKI vs non-AKI) or severity of AKI (HR, 1.54; 95% CI, 0.50-4.72 for AKI stage 1 vs non-AKI; HR, 0.56; 95% CI, 0.07-4.84 for AKI stage 2 vs non-AKI; HR, 2.24; 95% CI, 0.33-15.29 for AKI stage 3 vs non-AKI) was not independently associated with more rapid kidney disease progression. Conclusions and Relevance: Proteinuria level is a valuable risk-stratification tool in the post-AKI period. These results suggest there should be more widespread and routine quantification of proteinuria after hospitalized AKI.

Response evaluation for immunotherapy through semi-automatic software based on RECIST 1.1, irRC, and iRECIST criteria: comparison with subjective assessment.

BACKGROUND: Pseudoprogression is difficult to diagnose in patients undergoing immunotherapy. Subjective response assessment is still common in clinical practice. PURPOSE: To evaluate the differences between response evaluation criteria in solid tumors version 1.1 (RECIST 1.1), immune-related response criteria (irRC), and modified RECIST 1.1 for immunotherapy (iRECIST) through semi-automatic software, and to compare iRECIST-based response evaluation with subjective assessment. MATERIAL AND METHODS: The best overall response of each patient based on RECIST 1.1, irRC, and iRECIST was determined on CT scans through semi-automatic software and the differences between the criteria were evaluated. Criteria-based response evaluation through semi-automatic software was compared with subjective assessment on radiology report by correlating the best overall response to overall survival. RESULTS: A total of 21 patients were included (five patients with melanoma, 12 patients with non-small-cell lung cancer, and four patients with hepatocellular carcinoma). Two patients with progressive disease by RECIST 1.1 but non-progressive disease by irRC and iRECIST eventually experienced tumor response and had favorable outcomes, indicating pseudoprogression. The survival difference between patients with non-progressive disease and progressive disease was better stratified through iRECIST-based response evaluation (P = 0.078) than that through subjective assessment (P = 0.501). CONCLUSION: Pseudoprogression in immunotherapy may be captured through semi-automatic software utilizing irRC or iRECIST criteria. iRECIST-based response evaluation may provide a better survival stratification compared with subjective assessment.

Metformin for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus.

BACKGROUND: The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether metformin can prevent or delay T2DM and its complications in people with increased risk of developing T2DM is unknown. OBJECTIVES: To assess the effects of metformin for the prevention or delay of T2DM and its associated complications in persons at increased risk for the T2DM. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, Scopus, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was March 2019. SELECTION CRITERIA: We included randomised controlled trials (RCTs) with a duration of one year or more comparing metformin with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or standard care in people with impaired glucose tolerance, impaired fasting glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or combinations of these. DATA COLLECTION AND ANALYSIS: Two review authors read all abstracts and full-text articles and records, assessed risk of bias and extracted outcome data independently. We used a random-effects model to perform meta-analysis and calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included 20 RCTs randomising 6774 participants. One trial contributed 48% of all participants. The duration of intervention in the trials varied from one to five years. We judged none of the trials to be at low risk of bias in all 'Risk of bias' domains. Our main outcome measures were all-cause mortality, incidence of T2DM, serious adverse events (SAEs), cardiovascular mortality, non-fatal myocardial infarction or stroke, health-related quality of life and socioeconomic effects.The following comparisons mostly reported only a fraction of our main outcome set. Fifteen RCTs compared metformin with diet and exercise with or without placebo: all-cause mortality was 7/1353 versus 7/1480 (RR 1.11, 95% CI 0.41 to 3.01; P = 0.83; 2833 participants, 5 trials; very low-quality evidence); incidence of T2DM was 324/1751 versus 529/1881 participants (RR 0.50, 95% CI 0.38 to 0.65; P < 0.001; 3632 participants, 12 trials; moderate-quality evidence); the reporting of SAEs was insufficient and diverse and meta-analysis could not be performed (reported numbers were 4/118 versus 2/191; 309 participants; 4 trials; very low-quality evidence); cardiovascular mortality was 1/1073 versus 4/1082 (2416 participants; 2 trials; very low-quality evidence). One trial reported no clear difference in health-related quality of life after 3.2 years of follow-up (very low-quality evidence). Two trials estimated the direct medical costs (DMC) per participant for metformin varying from $220 to $1177 versus $61 to $184 in the comparator group (2416 participants; 2 trials; low-quality evidence). Eight RCTs compared metformin with intensive diet and exercise: all-cause mortality was 7/1278 versus 4/1272 (RR 1.61, 95% CI 0.50 to 5.23; P = 0.43; 2550 participants, 4 trials; very low-quality evidence); incidence of T2DM was 304/1455 versus 251/1505 (RR 0.80, 95% CI 0.47 to 1.37; P = 0.42; 2960 participants, 7 trials; moderate-quality evidence); the reporting of SAEs was sparse and meta-analysis could not be performed (one trial reported 1/44 in the metformin group versus 0/36 in the intensive exercise and diet group with SAEs). One trial reported that 1/1073 participants in the metformin group compared with 2/1079 participants in the comparator group died from cardiovascular causes. One trial reported that no participant died due to cardiovascular causes (very low-quality evidence). Two trials estimated the DMC per participant for metformin varying from $220 to $1177 versus $225 to $3628 in the comparator group (2400 participants; 2 trials; very low-quality evidence). Three RCTs compared metformin with acarbose: all-cause mortality was 1/44 versus 0/45 (89 participants; 1 trial; very low-quality evidence); incidence of T2DM was 12/147 versus 7/148 (RR 1.72, 95% CI 0.72 to 4.14; P = 0.22; 295 participants; 3 trials; low-quality evidence); SAEs were 1/51 versus 2/50 (101 participants; 1 trial; very low-quality evidence). Three RCTs compared metformin with thiazolidinediones: incidence of T2DM was 9/161 versus 9/159 (RR 0.99, 95% CI 0.41 to 2.40; P = 0.98; 320 participants; 3 trials; low-quality evidence). SAEs were 3/45 versus 0/41 (86 participants; 1 trial; very low-quality evidence). Three RCTs compared metformin plus intensive diet and exercise with identical intensive diet and exercise: all-cause mortality was 1/121 versus 1/120 participants (450 participants; 2 trials; very low-quality evidence); incidence of T2DM was 48/166 versus 53/166 (RR 0.55, 95% CI 0.10 to 2.92; P = 0.49; 332 participants; 2 trials; very low-quality evidence). One trial estimated the DMC of metformin plus intensive diet and exercise to be $270 per participant compared with $225 in the comparator group (94 participants; 1 trial; very-low quality evidence). One trial in 45 participants compared metformin with a sulphonylurea. The trial reported no patient-important outcomes. For all comparisons there were no data on non-fatal myocardial infarction, non-fatal stroke or microvascular complications. We identified 11 ongoing trials which potentially could provide data of interest for this review. These trials will add a total of 17,853 participants in future updates of this review. AUTHORS' CONCLUSIONS: Metformin compared with placebo or diet and exercise reduced or delayed the risk of T2DM in people at increased risk for the development of T2DM (moderate-quality evidence). However, metformin compared to intensive diet and exercise did not reduce or delay the risk of T2DM (moderate-quality evidence). Likewise, the combination of metformin and intensive diet and exercise compared to intensive diet and exercise only neither showed an advantage or disadvantage regarding the development of T2DM (very low-quality evidence). Data on patient-important outcomes such as mortality, macrovascular and microvascular diabetic complications and health-related quality of life were sparse or missing.

Utilization and medical costs of outpatient rehabilitation among children with autism spectrum conditions in Taiwan.

BACKGROUND: We examined the utilization of rehabilitation resources among children with autism spectrum condition (ASC), a neurodevelopmental condition, in Taiwan. METHODS: We derived from the National Health Insurance Research Database of Taiwan data pertaining to 3- to 12-year-old children for the period 2008-2010. Based on diagnoses executed in accordance with the International Classification of Diseases, Ninth Revision, Clinical Modification, we classified these data into the ASC and non-ASC groups and analyzed them through multiple linear regression model, negative binomial model, independent sample t testing, and χ2 testing. RESULTS: Compared with the non-ASC group, the ASC group exhibited higher utilization of rehabilitation resources. Because hospitals are constrained by overall expenditure limits, expenditure on rehabilitation resources has plateaued, preventing any increase in the utilization of rehabilitation resources. In our ASC group, preschool-aged children significantly outnumbered (p < 0.001) school-aged children. When stratified by the hospital level, district hospitals reported the highest utilization (p < 0.001). When stratified by region, the highest utilization was in Taipei, whereas the lowest was in the East region (p < 0.001). The total annual cost, average frequency of visits, utilization of rehabilitation resources, and average cost were all affected by such elements as patient demographics, hospital type and location (p < 0.001). CONCLUSIONS: For improving treatment outcomes among children with ASC and decreasing treatment expenditure, policies that promote the timely ASC detection and treatment should be implemented.

Statistical methods for building better biomarkers of chronic kidney disease.

The last two decades have witnessed an explosion in research focused on the development and assessment of novel biomarkers for improved prognosis of diseases. As a result, best practice standards guiding biomarker research have undergone extensive development. Currently, there is great interest in the promise of biomarkers to enhance research efforts and clinical practice in the setting of chronic kidney disease, acute kidney injury, and glomerular disease. However, some have questioned whether biomarkers currently add value to the clinical practice of nephrology. The current state of the art pertaining to statistical analyses regarding the use of such measures is critical. In December 2014, the National Institute of Diabetes and Digestive and Kidney Diseases convened a meeting, "Toward Building Better Biomarker Statistical Methodology," with the goals of summarizing the current best practice recommendations and articulating new directions for methodological research. This report summarizes its conclusions and describes areas that need attention. Suggestions are made regarding metrics that should be commonly reported. We outline the methodological issues related to traditional metrics and considerations in prognostic modeling, including discrimination and case mix, calibration, validation, and cost-benefit analysis. We highlight the approach to improved risk communication and the value of graphical displays. Finally, we address some "new frontiers" in prognostic biomarker research, including the competing risk framework, the use of longitudinal biomarkers, and analyses in distributed research networks.

Distribution and pollution assessment of heavy metals in the intertidal zone environments of typical sea areas in China.

The heavy metals (Cu, Cr, Zn, Cd, Pb) were analysed for 217 surface sediment samples collected across 14 typical intertidal zone areas in China. The data reveals the heavy metals spatial distribution patterns and correlations among their concentrations. Cu, Zn, Cd and Cr showed similar trends of spatial variation and the correlations between the concentrations of every two heavy metals were significantly positive except for the correlation between Pb and Cr concentrations. By using Nemerow index method, Enrichment factor and Sediment Quality Guidelines, it is found that Hangzhou Bay and Jiulong River Estuary were polluted, Yingluo Bay and Dongzhaigang Bay were Cd-rich areas. Except Beidaihe shoal, Sishili Bay and Yingluo Bay that were not exposed to any ecological risk of heavy metals and had no adverse biotoxic effects, the other 11 typical intertidal zone areas were exposed to moderate ecological risk of heavy metals in the sediment with potential adverse biotoxic effects.

Interventions to Improve Blood Pressure Control Among Socioeconomically Disadvantaged Patients With CKD: Kidney Awareness Registry and Education Pilot Randomized Controlled Trial.

RATIONALE & OBJECTIVE: Sustainable interventions that enhance chronic kidney disease (CKD) management are not often studied in safety-net primary care, in which populations bear a disproportionate burden of disease and experience translational gaps between research and practice. We tested the feasibility of implementing and the impact of 2 technology-enhanced interventions designed to enhance CKD care delivery. STUDY DESIGN: A 2×2 randomized controlled pilot trial. SETTING & PARTICIPANTS: Primary care provider teams (n = 6) and 137 patients with CKD aged 18 to 75 years from 2 safety-net primary care clinics, 2013 to 2015. INTERVENTIONS: Primary care provider teams were randomly assigned to access a CKD registry with point-of-care notifications and quarterly feedback or a usual-care registry for 12 months. Patients within provider teams were randomly assigned to participate in a CKD self-management support program or usual care for 12 months. OUTCOMES: We examined recruitment, randomization, and participation in each intervention. We also examined the impact of each intervention and their combination on change in systolic blood pressure (SBP), albuminuria, and patient self-reported behavioral measures after 12 months. RESULTS: Among potentially eligible patients identified using the electronic health record, 24% were eligible for study participation, of whom 35% (n = 137) were enrolled. Mean age was 55 years, 41% were non-English speaking, and 93% were of racial/ethnic minority. Mean baseline estimated glomerular filtration rate was 70.5 (SD = 30.3) mL/min/1.73 m2; mean baseline SBP was 131 (SD = 21.8) mm Hg. Nearly 90% of clinicians reported that the CKD registry influenced their CKD management. More than 95% of patients randomly assigned to CKD self-management support engaged regularly with the intervention. Estimated changes in SBP over 1 year were nonstatistically different in each of the 3 intervention groups compared with usual care: (usual care: 0.5 [95% CI, -5.2 to 6.3] mm Hg; CKD registry only: -5.4 [95% CI, -12.2 to 1.4] mm Hg; CKD self-management support only: -6.4 [95% CI, -13.7 to 1.0] mm Hg; and CKD registry plus CKD self-management support: -0.5 [-5.5 to 4.5] mm Hg), though differences were larger among those with baseline SBPs > 140/90 mm Hg. Decreases in albuminuria were similarly nonstatistically different in each of the intervention groups compared with usual care. No differences were observed in patient self-reported behaviors. LIMITATIONS: Single health system. CONCLUSIONS: Patient and provider interventions to improve CKD care are feasible to implement in low-income settings with promising results among those with uncontrolled blood pressure. FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: ClinicalTrials.gov, number: NCT01530958.

Risk Factors for Recurrent Acute Kidney Injury in a Large Population-Based Cohort.

RATIONALE & OBJECTIVE: Acute kidney injury (AKI) has numerous sequelae. Repeated episodes of AKI may be an important determinant of adverse outcomes, including chronic kidney disease and death. In a population-based cohort study, we sought to determine the incidence of and predictors for recurrent AKI. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: 38,659 hospitalized members of Kaiser Permanente Northern California who experienced an episode of AKI from 2006 to 2013. PREDICTORS: Demographic, clinical, and laboratory data, including baseline kidney function, proteinuria, hemoglobin level, comorbid conditions, and severity of AKI. OUTCOMES: Incidence and predictors of recurrent AKI. ANALYTICAL APPROACH: Multivariable Cox proportional hazard regression. RESULTS: 11,048 (28.6%) experienced a second hospitalization complicated by AKI during follow-up (11.2 episodes/100 person-years), with the second episode of AKI occurring a median of 0.6 (interquartile range, 0.2-1.9) years after the first hospitalization. In multivariable analyses, older age, black race, and Hispanic ethnicity were associated with recurrent AKI, along with lower estimated glomerular filtration rate, proteinuria, and anemia. Concomitant conditions, including heart failure, acute coronary syndrome, diabetes, and chronic liver disease, were also multivariable predictors of recurrent AKI. Those who had higher acuity of illness during the initial hospitalization were more likely to have recurrent AKI, but greater AKI severity of the index episode was not independently associated with increased risk for recurrent AKI. In multivariable analysis of matched patients, recurrent AKI was associated with an increased rate of death (HR, 1.66; 95% CI, 1.57-1.77). LIMITATIONS: Analyses were based on clinically available data, rather than protocol-driven timed measurements of kidney function. CONCLUSIONS: Recurrent AKI is a common occurrence after a hospitalization complicated by AKI. Based on routinely available patient characteristics, our findings could facilitate identification of the subgroup of patients with AKI who may benefit from more intensive follow-up to potentially avoid recurrent AKI episodes.

A 12-year analysis of closed medical malpractice claims of the Taiwan civil court: A retrospective study.

Malpractices lawsuits cause increased physician stress and decreased career satisfaction, which might result in defensive medicine for avoiding litigation. It is, consequently, important to learn experiences from previous malpractice claims. The aim of this study was to examine the epidemiologic factors related to medical malpractice claims, identify specialties at high risk of such claims, and determine clinical which errors tend to lead to medical malpractice lawsuits, by analyzing closed malpractice claims in the civil courts of Taiwan.The current analysis reviewed the verdicts of the Taiwan judicial system from a retrospective study using the population-based databank, focusing on 946 closed medical claims between 2002 and 2013.Among these medical malpractice claims, only 14.1% of the verdicts were against clinicians, with a mean indemnity payment of $83,350. The most common single specialty involved was obstetrics (10.7%), while the surgery group accounted for approximately 40% of the cases. In total, 46.3% of the patients named in the claims had either died or been gravely injured. Compared to the $75,632 indemnity for deceased patients, the mean indemnity payment for plaintiffs with grave outcomes was approximately 4.5 times higher. The diagnosis groups at high risk of malpractice litigation were infectious diseases (7.3%), malignancies (7.2%), and limb fractures (4.9%). A relatively low success rate was found in claims concerning undiagnosed congenital anomalies (4.5%) and infectious diseases (5.8%) group. A surgery dispute was the most frequent argument in civil malpractice claims (38.8%), followed by diagnosis error (19.3%).Clinicians represent 85.9% of the defendants who won their cases, but they spent an average of 4.7 years to reach final adjudication. Increased public education to prevent unrealistic expectations among patients is recommended to decrease frivolous lawsuits. Further investigation to improve the lengthy judicial process is also necessary to relieve the stress of medical malpractice claims on clinicians and practitioners, as well as on the judicial system and rightful claimants.

Evaluation on island ecological vulnerability and its spatial heterogeneity.

The evaluation on island ecological vulnerability (IEV) can help reveal the comprehensive characteristics of the island ecosystem and provide reference for controlling human activities on islands. An IEV evaluation model which reflects the land-sea dual features, natural and anthropogenic attributes, and spatial heterogeneity of the island ecosystem was established, and the southern islands of Miaodao Archipelago in North China were taken as the study area. The IEV, its spatial heterogeneity, and its sensitivities to the evaluation elements were analyzed. Results indicated that the IEV was in status of mild vulnerability in the archipelago scale, and population pressure, ecosystem productivity, environmental quality, landscape pattern, and economic development were the sensitive elements. The IEV showed significant spatial heterogeneities both in land and surrounding waters sub-ecosystems. Construction scale control, optimization of development allocation, improvement of exploitation methods, and reasonable ecological construction are important measures to control the IEV.

Learning from an analysis of closed malpractice litigation involving myocardial infarction.

OBJECTIVE: To examine the epidemiologic data, identify the pattern of dispute, and determine clinical litigious errors by analyzing closed malpractice claims involving myocardial infarction (MI) in Taiwanese courts. METHODS: A retrospective descriptive study was performed to analyze the verdicts pertaining to MI from the population-based database of the Taiwan judicial system between 2002 and 2013. The results of adjudication, involved specialists, primary dispute leading to lawsuits, and litigious errors were recorded. RESULTS: A total of 36 closed malpractice claims involving MI were included. The mean interval between the incident and litigation closure was 65.5 ± 28.3 months. Nearly 20% of the cases were judged against clinicians and the mean payment was $100639 ± 49617, while the mean imprisonment sentence was 4.3 ± 1.8 months. Cardiologists and emergency physicians were involved in 56.3% of cases, but won 92.6% of lawsuits, while other specialists lost nearly 25% of lawsuits. The most common dispute was misdiagnosis (38.9%), but this dispute had the lowest percentage of loss (7.1%). Disputes regarding delayed diagnosis were judged against the defendants in 50% of claims. Clinicians lost the lawsuit in the following conditions: 1) misdiagnosis of MI in patients with typical chest pain and known coronary artery risk factors; 2) failure to perform thoughtful evaluation and series investigations in patients suspicious of ischemic heart disease; 3) failure to perform indicated treatment to avoid disease progression. CONCLUSIONS: Medical practitioners should keep a high index of MI suspicion, especially if the diagnosis and treatment of MI are beyond their daily practice. Prudent patient reevaluation, serial ECG and cardiac enzyme testing, and early consultation are suggested to reduce malpractice liability.