Resection for colorectal cancer in the very old: are the risks too high?

Altogether 277 consecutive patients aged 70 or more who were admitted for resection of colorectal cancer between 1975 and 1985 were studied. The postoperative complications and mortality in the 175 patients aged 70-79 were compared with those in the 102 patients aged 80 or more. The overall mortality was 11%. Mortality was significantly higher after resection in the older age group even when deaths from widespread malignancy were excluded from the analysis. After curative resection mortality was 2% (2/120) in the younger group and 7% (4/60) in the older group, but after palliative resection of tumours with local or distant spread mortality was significantly higher, at 21% (9/44) and 38% (12/32), respectively. An equal but high proportion of patients in both age groups suffered major complications, but complications caused significantly more deaths in the older group. The length of stay in hospital was not significantly different between the age groups. Patients should not be denied resection of a colorectal cancer because of age alone, especially if a curative operation is possible. The increased risk of death from major complications, particularly after palliative resection, should, however, be taken into account when an operation on patients over 80 is being considered.     

WebDISCO: a web service for distributed cox model learning without patient-level data sharing

Objective The Cox proportional hazards model is a widely used method for analyzing survival data. To achieve sufficient statistical power in a survival analysis, it usually requires a large amount of data. Data sharing across institutions could be a potential workaround for providing this added power.Methods and materials The authors develop a web service for distributed Cox model learning (WebDISCO), which focuses on the proof-of-concept and algorithm development for federated survival analysis. The sensitive patient-level data can be processed locally and only the less-sensitive intermediate statistics are exchanged to build a global Cox model. Mathematical derivation shows that the proposed distributed algorithm is identical to the centralized Cox model.Results The authors evaluated the proposed framework at the University of California, San Diego (UCSD), Emory, and Duke. The experimental results show that both distributed and centralized models result in near-identical model coefficients with differences in the range 10^?15 to 10^?12. The results confirm the mathematical derivation and show that the implementation of the distributed model can achieve the same results as the centralized implementation.Limitation The proposed method serves as a proof of concept, in which a publicly available dataset was used to evaluate the performance. The authors do not intend to suggest that this method can resolve policy and engineering issues related to the federated use of institutional data, but they should serve as evidence of the technical feasibility of the proposed approach.Conclusions WebDISCO (Web-based Distributed Cox Regression Model; https://webdisco.ucsd-dbmi.org:8443/cox/) provides a proof-of-concept web service that implements a distributed algorithm to conduct distributed survival analysis without sharing patient level data.     

Difference of sociodemographic characteristics among the disabled population in Cambodia: a cross-sectional study of the demographic and health survey data

Objective: There is an urgent need to raise awareness of the significance of the social security system for vulnerable populations in developing countries and identify the widening disparities among people with disabilities. This study determined the sociodemographic characteristics of people with disabilities in Cambodia.Materials and Methods: This was a cross-sectional study. Data from the Cambodia Demographic and Health Survey were used to determine the association between disability and sociodemographic characteristics such as age, gender, number of family members, residence (rural/urban), and economic status.Results: The results showed that the proportion of people with disabilities greatly increased with age. The rural-urban residence difference affected the disability proportion in univariate analysis; however, the effect was not significant after adjusting for covariables in multivariate analysis. The odds of having a disability were 0.85 times lower for the high economic status group than for the low economic status group.Conclusion: Raising awareness to expand the capacity of social support for older adults with disabilities, especially those who do not receive care from their families, may be an urgent issue in Cambodia. Therefore, a well-designed and disease-specific study is required. This study was the first to determine the sociodemographic disparities among people with disabilities in Cambodia.     

Gastroparesis and the gastric pacemaker: a revolutionary treatment for an old disease

Gastroparesis--or delayed gastric emptying--can apply to either solids or liquids but the term (gastroparesis) usually refers to delayed solid emptying, in an appropriate clinical setting. Impaired gastric emptying can occur acutely in a variety of conditions from neurologic to metabolic. Intractable nausea and vomiting, and the inability to tolerate oral intake, occurs frequently in patients with severe gastroparesis. The patients' nutritional status is adversely affected by gastroparesis as are the socioeconomic aspects of patient's lives. The previous treatments of gastroparesis, such as medications and surgery, were often not successful. Our recent understanding of the normal gastric electro-mechanical function and its abnormalities/dysrythmias has led to the development of a gastric electrical stimulator, analagous to other devices used to stimulate dysfunctional organs. Gastric electrical stimulation is associated with improvements in symptomatic relief, nutritional status, health resource utilization and costs and is now approved by the FDA as a humanitarian use device. It offers a new and hopeful therapy for patients with refractory gastroparesis where none have existed before.     

A system to build distributed multivariate models and manage disparate data sharing policies: implementation in the scalable national network for effectiveness research

Background Centralized and federated models for sharing data in research networks currently exist. To build multivariate data analysis for centralized networks, transfer of patient-level data to a central computation resource is necessary. The authors implemented distributed multivariate models for federated networks in which patient-level data is kept at each site and data exchange policies are managed in a study-centric manner.Objective The objective was to implement infrastructure that supports the functionality of some existing research networks (e.g., cohort discovery, workflow management, and estimation of multivariate analytic models on centralized data) while adding additional important new features, such as algorithms for distributed iterative multivariate models, a graphical interface for multivariate model specification, synchronous and asynchronous response to network queries, investigator-initiated studies, and study-based control of staff, protocols, and data sharing policies.Materials and Methods Based on the requirements gathered from statisticians, administrators, and investigators from multiple institutions, the authors developed infrastructure and tools to support multisite comparative effectiveness studies using web services for multivariate statistical estimation in the SCANNER federated network.Results The authors implemented massively parallel (map-reduce) computation methods and a new policy management system to enable each study initiated by network participants to define the ways in which data may be processed, managed, queried, and shared. The authors illustrated the use of these systems among institutions with highly different policies and operating under different state laws.Discussion and Conclusion Federated research networks need not limit distributed query functionality to count queries, cohort discovery, or independently estimated analytic models. Multivariate analyses can be efficiently and securely conducted without patient-level data transport, allowing institutions with strict local data storage requirements to participate in sophisticated analyses based on federated research networks.     

Brief communication: Developing a data infrastructure for a learning health system: the PORTAL network

The Kaiser Permanente & Strategic Partners Patient Outcomes Research To Advance Learning (PORTAL) network engages four healthcare delivery systems (Kaiser Permanente, Group Health Cooperative, HealthPartners, and Denver Health) and their affiliated research centers to create a new national network infrastructure that builds on existing relationships among these institutions. PORTAL is enhancing its current capabilities by expanding the scope of the common data model, paying particular attention to incorporating patient-reported data more systematically, implementing new multi-site data governance procedures, and integrating the PCORnet PopMedNet platform across our research centers. PORTAL is partnering with clinical research and patient experts to create cohorts of patients with a common diagnosis (colorectal cancer), a rare diagnosis (adolescents and adults with severe congenital heart disease), and adults who are overweight or obese, including those with pre-diabetes or diabetes, to conduct large-scale observational comparative effectiveness research and pragmatic clinical trials across diverse clinical care settings.     

Codesigning a community-based participatory research project to assess tribal perspectives on privacy and health data sharing: A report from the Strong Heart Study

Broad health data sharing raises myriad ethical issues related to data protection and privacy. These issues are of particular relevance to Native Americans, who reserve distinct individual and collective rights to control data about their communities. We sought to gather input from tribal community leaders on how best to understand health data privacy and sharing preferences in this population. We conducted a workshop with 14 tribal leaders connected to the Strong Heart Study to codesign a research study to assess preferences concerning health data privacy for biomedical research. Workshop participants provided specific recommendations regarding who should be consulted, what questions should be posed, and what methods should be used, underscoring the importance of relationship-building between researchers and tribal communities. Biomedical researchers and informaticians who collect and analyze health information from Native communities have a unique responsibility to safeguard these data in ways that align to the preferences of specific communities.     

Quantifying the federal minimal risk standard: implications for pediatric research without a prospect of direct benefit

David Wendler, PhD; Leah Belsky, AB; Kimberly M. Thompson, ScD; Ezekiel J. Emanuel, MD, PhD

JAMA. 2005;294:826-832.

United States federal regulations allow institutional review boards (IRBs) to approve pediatric research that does not offer participants a "prospect of direct" benefit only when the risks are minimal or a "minor" increase over minimal. The federal regulations define minimal risks based on the risks "ordinarily encountered in daily life or during routine physical or psychological examinations or tests." In the absence of empirical data, IRB members may assume they are familiar with the risks of daily life and with the risks of routine examinations and tests and rely on their own intuitive judgment to make these assessments. Yet intuitive judgment of risk is subject to systematic errors, highlighting the need for empirical data to guide IRB review and approval of pediatric research. Current data reveal that car trips pose the highest risk of mortality ordinarily encountered by healthy children. On average, these risks are approximately 0.06 per million for children aged 14 years and younger, and approximately 0.4 per million for children aged 15 through 19 years. Riskier, but still ordinary, car trips pose an approximately 0.6 per million chance of death for children aged 14 years and younger and an approximately 4 per million chance of death for children aged 15 through 19 years. Participation in sports represents the upper end of the range of morbidity risks for healthy children. For every million instances of playing basketball, approximately 1900 individuals will sustain injuries, including 180 broken bones and 58 permanent disabilities. These findings suggest IRBs are implementing the federal minimal risk standard too cautiously in many cases. These data also raise the question of whether the federal minimal risk standard may sometimes fail to provide sufficient protection for children, prompting the need to consider alternative standards.

     

Reducing the radiation dose with the adaptive statistical iterative reconstruction technique for chest CT in adults: a parameter study

Background Currently there is a trend towards reducing radiation dose while maintaining image quality during computer tomography （CT） examination.This results from the concerns about radiation exposure from CT and the potential increase in the incidence of radiation induced carcinogenesis.This study aimed to investigate the lowest radiation dose for maintaining good image quality in adult chest scanning using GE CT equipment.Methods Seventy-two adult patients were examined by Gemstone Spectral CT.They were randomly divided into six groups.We set up a different value of noise index （NI） when evaluating each group every other number from 13.0 to 23.0.The original images were acquired with a slice of 5 mm thickness.For each group,several image series were reconstructed using different levels of adaptive statistical iterative reconstruction （ASIR） （30％,50％,and 70％）.We got a total of 18 image sequences of different combinations of NI and ASIR percentage.On one hand,quantitative indicators,such as CT value and standard deviation （SD）,were assessed at the region of interest.The signal-to-noise ratio （SNR） and contrast-to-noise ratio （CNR） were calculated.The volume CT dose index （CTDI） and dose length product （DLP） were recorded.On the other hand,two radiologists with ＞5 years of experience blindly reviewed the subjective image quality using the standards we had previously set.Results The different combinations of noise index and ASIR were assessed.There was no significant difference in CT values among the 18 image sequences.The SD value was reduced with the noise index＇s reduction or ASIR＇s increase.There was a trend towards gradually lower SNR and CNR with an NI increase.The CTDI and DLP were diminishing as the NI increased.The scores from subjective image quality evaluation were reduced in all groups as the ASIR increased.Conclusions Increasing NI can reduce radiation dose.With the premise of maintaining the same image quality,using a suitable percentage of ASIR can increase the value of NI.To assure image quality,we concluded that when the NI was set at 17.0 and ASlR was 50％,the image quality could be optimal for not only satisfying the requirements of clinical diagnosis,but also achieving the purpose of low-dose scanning.     

The technology behind TB DEPOT: a novel public analytics platform integrating tuberculosis clinical,genomic, and radiological data for visual and statistical exploration

ObjectiveClinical research informatics tools are necessary to support comprehensive studies of infectious diseases. The National Institute of Allergy and Infectious Diseases (NIAID) developed the publicly accessible Tuberculosis Data Exploration Portal (TB DEPOT) to address the complex etiology of tuberculosis (TB).Materials and MethodsTB DEPOT displays deidentified patient case data and facilitates analyses across a wide range of clinical, socioeconomic, genomic, and radiological factors. The solution is built using Amazon Web Services cloud-based infrastructure, .NET Core, Angular, Highcharts, R, PLINK, and other custom-developed services. Structured patient data, pathogen genomic variants, and medical images are integrated into the solution to allow seamless filtering across data domains.ResultsResearchers can use TB DEPOT to query TB patient cases, create and save patient cohorts, and execute comparative statistical analyses on demand. The tool supports user-driven data exploration and fulfills the National Institute of Health’s Findable, Accessible, Interoperable, and Reusable (FAIR) principles.DiscussionTB DEPOT is the first tool of its kind in the field of TB research to integrate multidimensional data from TB patient cases. Its scalable and flexible architectural design has accommodated growth in the data, organizations, types of data, feature requests, and usage. Use of client-side technologies over server-side technologies and prioritizing maintenance have been important lessons learned. Future directions are dynamically prioritized and key functionality is shared through an application programming interface.ConclusionThis paper describes the platform development methodology, resulting functionality, benefits, and technical considerations of a clinical research informatics application to support increased understanding of TB.     

如何阅读医学论文(四)供非统计学家使用的统计学:不同类型数据要用不同统计方法检验

HowtoreadapaperStatisticsforthenon－statistician：DifferenttypesofdataneeddifferentStatisticaltestsTrishaGreenhalgh随着医学对数学依赖程度的日益增加,任何医生都不能将论文的统计处理全交给统计专家来做。如果你有一定的数学基础,不妨读一下加拿大医学会杂志中的“临床医生基础统计”系列讲座‘“,或更专业的统计教课书’。另外,如果你觉得统计学太难,本文和随后的系列文章可提供初步问题的一览表,以帮助你评价论文中统计方法的正确性。作者正确地设置了统计对象吗？他们确定的分组是可比的吗？需要对基线的差异作调整吗…     

Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review

ObjectiveReal-world data (RWD), defined as routinely collected healthcare data, can be a potential catalyst for addressing challenges faced in clinical trials. We performed a scoping review of database-specific RWD applications within clinical trial contexts, synthesizing prominent uses and themes.Materials and MethodsQuerying 3 biomedical literature databases, research articles using electronic health records, administrative claims databases, or clinical registries either within a clinical trial or in tandem with methodology related to clinical trials were included. Articles were required to use at least 1 US RWD source. All abstract screening, full-text screening, and data extraction was performed by 1 reviewer. Two reviewers independently verified all decisions.ResultsOf 2020 screened articles, 89 qualified: 59 articles used electronic health records, 29 used administrative claims, and 26 used registries. Our synthesis was driven by the general life cycle of a clinical trial, culminating into 3 major themes: trial process tasks (51 articles); dissemination strategies (6); and generalizability assessments (34). Despite a diverse set of diseases studied, <10% of trials using RWD for trial process tasks evaluated medications or procedures (5/51). All articles highlighted data-related challenges, such as missing values.DiscussionDatabase-specific RWD have been occasionally leveraged for various clinical trial tasks. We observed underuse of RWD within conducted medication or procedure trials, though it is subject to the confounder of implicit report of RWD use.ConclusionEnhanced incorporation of RWD should be further explored for medication or procedure trials, including better understanding of how to handle related data quality issues to facilitate RWD use.     

Clinical research data warehouse governance for distributed research networks in the USA: a systematic review of the literature

Objective

To review the published, peer-reviewed literature on clinical research data warehouse governance in distributed research networks (DRNs).

Materials and methods

Medline, PubMed, EMBASE, CINAHL, and INSPEC were searched for relevant documents published through July 31, 2013 using a systematic approach. Only documents relating to DRNs in the USA were included. Documents were analyzed using a classification framework consisting of 10 facets to identify themes.

Results

6641 documents were retrieved. After screening for duplicates and relevance, 38 were included in the final review. A peer-reviewed literature on data warehouse governance is emerging, but is still sparse. Peer-reviewed publications on UK research network governance were more prevalent, although not reviewed for this analysis. All 10 classification facets were used, with some documents falling into two or more classifications. No document addressed costs associated with governance.

Discussion

Even though DRNs are emerging as vehicles for research and public health surveillance, understanding of DRN data governance policies and procedures is limited. This is expected to change as more DRN projects disseminate their governance approaches as publicly available toolkits and peer-reviewed publications.

Conclusions

While peer-reviewed, US-based DRN data warehouse governance publications have increased, DRN developers and administrators are encouraged to publish information about these programs.     

Research Integrated Network of Systems (RINS): a virtual data warehouse for the acceleration of translational research

ObjectiveIntegrated, real-time data are crucial to evaluate translational efforts to accelerate innovation into care. Too often, however, needed data are fragmented in disparate systems. The South Carolina Clinical & Translational Research Institute at the Medical University of South Carolina (MUSC) developed and implemented a universal study identifier—the Research Master Identifier (RMID)—for tracking research studies across disparate systems and a data warehouse-inspired model—the Research Integrated Network of Systems (RINS)—for integrating data from those systems.Materials and MethodsIn 2017, MUSC began requiring the use of RMIDs in informatics systems that support human subject studies. We developed a web-based tool to create RMIDs and application programming interfaces to synchronize research records and visualize linkages to protocols across systems. Selected data from these disparate systems were extracted and merged nightly into an enterprise data mart, and performance dashboards were created to monitor key translational processes.ResultsWithin 4 years, 5513 RMIDs were created. Among these were 726 (13%) bridged systems needed to evaluate research study performance, and 982 (18%) linked to the electronic health records, enabling patient-level reporting.DiscussionBarriers posed by data fragmentation to assessment of program impact have largely been eliminated at MUSC through the requirement for an RMID, its distribution via RINS to disparate systems, and mapping of system-level data to a single integrated data mart.ConclusionBy applying data warehousing principles to federate data at the “study” level, the RINS project reduced data fragmentation and promoted research systems integration.     

Circumferential decompression via the posterior approach for the surgical treatment of multilevel thoracic ossification of the posterior longitudinal ligaments: a single institution comparative study

Background The treatment strategies for multilevel thoracic ossification of the posterior longitudinal ligaments (T-OPLL) were rarely reported. The aim of this study was to investigate the clinical outcomes and complications of circumferential decompression for multilevel T-OPLL and compare two different methods in the management of the OPLL (resection or floating).

Methods Data of sequentially treated patients who received surgical treatment for thoracic spinal stenosis caused by multilevel T-OPLL from January 2005 to February 2012 were retrospectively reviewed. Based on the surgical approaches applied, the patients were divided into two groups. Group A consisted the patients who received posterior decompression and group B consisted the patients who received circumferential decompression via the posterior approach. Group B was further divided into two subgroups: subgroup 1 (the resection group) where the OPLL was completely resected and subgroup 2 (the floating group) where the OPLL was floated.

Results A total of 49 patients were included in the study. Fourteen patients with single posterior decompression were included in group A and 35 patients who received circumferential decompression were included in group B. In group B, 29 patients had complete resection of the ossified posterior longitudinal ligaments, while the other six underwent a flotation procedure. The follow-up data were available in 39 patients. Mean JOA scores improved from 5.4 ± 1.8 to 7.5 ± 2.8 in group A and from 3.7 ± 1.8 to 7.9 ± 2.4 in group B. The main complications included cerebrospinal fluid (CSF) leakage and postoperative neurologic deterioration (ND). Twenty-three of the 25 cases with postoperative CSF leakage achieved a complete recovery at the last follow-up and 12 of the 15 cases with ND achieved some neurological improvement at the last follow-up.

Conclusions Circumferential decompression via the posterior approach is an effective surgical method for thoracic spinal stenosis caused by multilevel OPLL of the thoracic spine. Patients who receive complete resection of the ossified posterior longitudinal ligaments may have better recovery rate than the “floating” group.

     

Bridging the integration gap between imaging and information systems: a uniform data concept for content-based image retrieval in computer-aided diagnosis

It is widely accepted that content-based image retrieval (CBIR) can be extremely useful for computer-aided diagnosis (CAD). However, CBIR has not been established in clinical practice yet. As a widely unattended gap of integration, a unified data concept for CBIR-based CAD results and reporting is lacking. Picture archiving and communication systems and the workflow of radiologists must be considered for successful data integration to be achieved. We suggest that CBIR systems applied to CAD should integrate their results in a picture archiving and communication systems environment such as Digital Imaging and Communications in Medicine (DICOM) structured reporting documents. A sample DICOM structured reporting template adaptable to CBIR and an appropriate integration scheme is presented. The proposed CBIR data concept may foster the promulgation of CBIR systems in clinical environments and, thereby, improve the diagnostic process.     

神经激肽1受体拮抗剂替代地塞米松二联方案预防中度致吐风险化疗所致恶心呕吐的随机对照试验

[摘要] 目的 探索MEC-CINV治疗中NK-1受体拮抗剂（阿瑞匹坦或福沙匹坦）联合托烷司琼的二联止吐方案非劣效于地塞米松联合托烷司琼的标准阳性二联止吐方案,为MEC-CINV治疗去糖皮质激素化提供参考依据。方法 将接受MEC-CINV治疗的患者,随机分配进入A组（NK-1受体拮抗剂+托烷司琼）和B组（托烷司琼+地塞米松）并给予对应的止吐方案。主要评价指标：两组患者总体期(0-120h)恶心呕吐完全缓解（CR）率、两组患者延迟期(24-120h)、急性期(0-24h)的CR率。次要评价指标：两组患者各期恶心完全控制（CC）率及总缓解（TR）率。NK-1受体拮抗剂（阿瑞匹坦或福沙匹坦）联合托烷司琼止吐的安全性。结果 主要评价指标：总体期CR率：58.8% vs 56.0%,P非劣效=0.035＞0.025,RD[95%CI]=2.80[-16.5 to 22.1],非劣效性检验无统计学意义;延迟期CR率：62.7% vs 58.0%,P非劣效=0.021＜0.025,RD[95%CI]=4.70[-14.4 to 23.8]、急性期CR率：80.4% vs 78.0%,P非劣效=0.016＜0.025,RD[95%CI]=2.40[-13.4 to 18.2]延迟、急性期非劣效性检验具有统计学意义。进一步行差异性卡方检验,两组间各期有效率P卡方＞0.05,差异皆无统计学意义。次要评价指标：对恶心症状的控制,A组各期略优于B组,P非劣效＜0.025。各安全性指标在两组间卡方检验P＞0.05,无统计学差异。结论 在MEC-CINV中,NK-1受体拮抗剂（阿瑞匹坦或福沙匹坦）联合托烷司琼的止吐方案对恶心呕吐的控制疗效良好,在急性期和延迟期非劣效于含地塞米松标准二联治疗,安全性也与标准治疗组相似。