Use Of Data In Research Research Articles

Data sharing platforms for de-identified data from human clinical trials.

Data sharing of de-identified individual participant data is being adopted by an increasing number of sponsors of human clinical trials. In addition to standardizing data syntax for shared trial data, semantic integration of various data elements is the focus of several initiatives that define research common data elements. This perspective article, in the first part, compares several data sharing platforms for de-identified clinical research data in terms of their size, policies and supported features. In the second part, we use a case study approach to describe in greater detail one data sharing platform (Data Share from National Institute of Drug Abuse). We present data on the past use of the platform, data formats offered, data de-identification approaches and its use of research common data elements. We conclude with a summary of current and expected future trends that facilitate secondary research use of data from completed human clinical trials.

THE NATIONAL ALZHEIMER'S COORDINATING CENTER: QUERYING THE DATABASE AND REQUESTING DATA

The National Alzheimer's Coordinating Center (NACC) was established in 1999 to standardize data and facilitate collaborative research use of data across the approximately 32 Alzheimer's Disease Centers (ADCs) funded by the National Institute of Aging (NIA). Standardized, longitudinal data collection through the Uniform Data Set (UDS) was implemented in September of 2005. The NACC database includes the UDS, neuropathology, MRI, amyloid PET, CSF biomarker, APOE genotype, and the FTLD module. Using HTML, Javascript, and SAS, NACC has developed web-based query and data request systems for public access to these types of data. An intuitive web-based query system was developed for researchers to easily summarize NACC data. Researchers can choose up to 3 variables, which include derived variables that combine or categorize one or more data elements from the NACC database. Frequency tables are presented with descriptive table headings and titles in an easy-to-read format. Table footnotes provide links to source variables and documents for query selections. To take full advantage of the extensive database, researchers can also submit a data request online. NACC consultants will work directly with the researcher to customize a dataset to match their research question. Typically within a few days, the researcher will receive a password-protected link to download their personalized dataset. The NACC database currently has 34,748 subjects with 116,271 visits. The innovative query system design requires no knowledge of SQL or programming to access these data. With the large number of data elements, NACC consultants are available to assist researchers with their comprehensive knowledge of the NACC database. As the ADCs continue to collect more patient data, the NACC database continues to grow in size and value over time. The user-friendly web-based query system allows researchers to quickly assess whether NACC has sufficient sample size to address their research question. It is also recommended, for publication purposes, that researchers request a custom data file by completing a brief form on the NACC website (https://www.alz.washington.edu/WEB/researcher_home.html).

Improving Cancer Care Through the Patient Experience: How to Use Patient-Reported Outcomes in Clinical Practice.

Poorly controlled symptoms are common and debilitating during cancer treatment and can affect functional status and quality of life, health care resource utilization, treatment adherence, and cancer survivorship. Historically, the patient experience, including symptoms during treatment, has not been tracked or documented in the patient health record. Measurement of patient-reported outcomes (PROs), including symptoms, is an essential component to cancer care focused on the illness impact to the patient and family. PROs can be useful at the individual level for monitoring and promoting symptom care both in the clinic and remotely and at the population level for aggregating population data for use in research and quality improvement initiatives. Implementation of PROs in cancer clinical care requires a carefully thought out process to overcome challenges related to integrating PROs into existing electronic health records and clinical work flow. Issues with implementing PRO collection may include making decisions about measurement tools, modes of delivery, frequency of measurement, and interpretation that are guided by a clarification of the purpose for collecting PROs. We focus on three aspects of PRO use: (1) improving care for individual patients, (2) analyzing aggregated data to improve care and outcomes overall, and (3) considerations in implementing PRO collection.

Creating a Single Application and Approval Process to Enable Research; an example using CPRD Primary Care Data and Public Health England Cancer Registry Data

ABSTRACTObjectivesTo enhance the research value and capability of its primary care database, the Clinical Practice Research Datalink (CPRD) has collaborated with Public Health England (PHE)’s National Cancer Registration and Analysis Service to facilitate access to linked cancer registration data for use in research, pharmacovigilance, drug monitoring and health outcomes analysis. Since 2009, access to this linked resource has been co-managed by CPRD and PHE, through two parallel, independent approvals processes: (a) the MHRA Independent Scientific Advisory Committee (ISAC) and (b) the PHE Office for Data Release (ODR). In upholding the Office for Life Science Ministerial Industry Strategy Group (Health Data Programme)’s vision to minimise process barriers to accessing real world data, CPRD and PHE have worked together to unify and streamline these two processes into a single end-to-end application and approval process.
 ApproachEach organisation reviewed each other’s approval processes to achieve an improved mutual understanding of the respective organisation’s governance approach, the risk based assessments applied to disclosure risk, risk appetites and policies, with the goal to harmonise these into a single approval process.
 ResultsCPRD and PHE are finalising a contract establishing a clear operating framework allowing CPRD to grant approval to researchers for the use of linked cancer registry data. The contract names CPRD as a joint data controller and sets out the purposes for processing, the manner of processing and the means by which joint data controller responsibilities will be satisfied. An associated service level agreement is in discussion which will enable robust timelines and performance management for both organisations. These developments are important milestones towards achieving the single approval process by allowing CPRD to review applications for cancer registry data in-house, simultaneously to the ISAC review.
 ConclusionThe strong relationship built between CPRD and PHE, and willingness to develop a single application and approval process, will strengthen and streamline access to these data, whilst assuring patients and the public that scientific integrity is maintained and proportionate information governance checks are in place. Upon completion of this work, applicants will experience associated faster review and feedback time, ultimately leading to faster approvals. Researchers wishing to utilise these linked data will soon be able to submit one application to ISAC, have one point of contact and one approval.

Improving Cancer Care Through the Patient Experience: How to Use Patient-Reported Outcomes in Clinical Practice

Poorly controlled symptoms are common and debilitating during cancer treatment and can affect functional status and quality of life, health care resource utilization, treatment adherence, and cancer survivorship. Historically, the patient experience, including symptoms during treatment, has not been tracked or documented in the patient health record. Measurement of patient-reported outcomes (PROs), including symptoms, is an essential component to cancer care focused on the illness impact to the patient and family. PROs can be useful at the individual level for monitoring and promoting symptom care both in the clinic and remotely and at the population level for aggregating population data for use in research and quality improvement initiatives. Implementation of PROs in cancer clinical care requires a carefully thought out process to overcome challenges related to integrating PROs into existing electronic health records and clinical work flow. Issues with implementing PRO collection may include making decisions about measurement tools, modes of delivery, frequency of measurement, and interpretation that are guided by a clarification of the purpose for collecting PROs. We focus on three aspects of PRO use: (1) improving care for individual patients, (2) analyzing aggregated data to improve care and outcomes overall, and (3) considerations in implementing PRO collection.

COMBINING ELECTRONIC HEALTH RECORDS AND NEUROIMAGING DATA FOR RESEARCH USE

COMBINING ELECTRONIC HEALTH RECORDS AND NEUROIMAGING DATA FOR RESEARCH USE

Data quality assessment framework to assess electronic medical record data for use in research

IntroductionThe proliferation and use of electronic medical records (EMR) in the clinical setting now provide a rich source of clinical data that can be leveraged to support research on patient outcomes, comparative effectiveness, and health systems research. Once the large volume and variety of data that robust clinical EMRs provide is aggregated, the suitability of the data for research purposes must be addressed. Therefore, the purpose of this paper is two-fold. First, we present a stepwise framework capable of guiding initial data quality assessment when matching multiple data sources regardless of context or application. Then, we demonstrate a use case of initial analysis of a longitudinal data repository of electronic health record data that illustrates the first four steps of the framework, and report results. MethodsA six-step data quality assessment framework is proposed and described that includes the following data quality assessment steps: (1) preliminary analysis, (2) documentation–longitudinal concordance, (3) breadth, (4) data element presence, (5) density, and (6) prediction. The six-step framework was applied to the Transport Data Mart—a data repository that contains over 28,000 records for patients that underwent interhospital transfer that includes EMRs from the sending hospitalization, transport, and receiving hospitalization. ResultsThere were a total of 9557 log entries of which 8139 were successfully matched to corresponding hospital encounters. 2832 were successfully mapped to both the sending and receiving hospital encounters (resulting in a 93% automatic matching rate), with 590 including air medical transport EMR data representing a complete case for testing. Results from Step 2 indicate that once records are identified and matched, there appears to be relatively limited drop-off of additional records when the criteria for matching increases, indicating the a proportion of records consistently contain nearly complete data. Measures of central tendency used in Step 3 and 4 exhibit a right skewness suggesting that a small proportion of records contain the highest number of repeated measures for the measured variables. ConclusionsThe proposed six-step data quality assessment framework is useful in establishing the metadata for a longitudinal data repository that can be replicated by other studies. There are practical issues that need to be addressed including the data quality assessments—with the most prescient being the need to establish data quality metrics for benchmarking acceptable levels of EMR data inclusiveness through testing and application.

Virology research in a Latin American developing country: a bibliometric analysis of virology in Colombia (2000–2013)

Bibliometric analysis demonstrates that the virology research in Latin America has increased. For this reason, the objective of this study was to evaluate Colombian publications on viruses and viral diseases in indexed journals during the period from 2000 to 2013. The bibliographic data were collected from MedLine, SciELO, LILACS and Scopus databases. The database was constructed in Excel descriptive statistics. The SCImago Journal Rank (SJR) was evaluated using the SCImago Journal & Country Rank in 2013 and was used as an indicator of the quality of the journals used by the Colombian researchers. The total number of papers published was 711, of which 40.4% were published in local journals, and 59.6% were published in foreign journals. Most (89.2%) were original papers. Moreover, 34.2% of the papers were published in collaboration with international researchers, with the United States being the most represented. Of the journals used, 85.6% had an SJR, and 14.4% did not. The median SJR of the papers was 0.789, and the median of the papers with international collaborators was higher compared to the SJR of the papers without international collaboration. Papers were most frequently published in journals whose categories were medicine (miscellaneous), virology, and infectious diseases. The viruses that appeared in the papers more frequently were HIV, dengue, and papillomavirus. This study provides data for use in research, health planning, and policy analysis as it relates to virology in Colombia and other developing Latin American countries.

A comparative analysis of the requirements for the use of data in biobanks based in Finland, Germany, the Netherlands, Norway and the United Kingdom

To understand the causes of disease and improve diagnosis and treatment regimes, biomedical researchers need access to large numbers of well-characterized data and samples. Over the past decade, biobanks have been established across Europe to collect and manage access to data and samples. The challenge that we face is how to develop the tools and collaborations to enable researchers to access samples and data from a network of biobanks, rather than applying to individual biobanks. One of the perceived stumbling blocks to achieving this is represented by the different legal requirements in each country. The aim of the BioSHaRE-European Union (EU) project is to address these challenges by developing tools and methods for researchers to access and use pooled data from different cohort and biobank studies. The purpose of this article is to identify and compare the key legal requirements regarding research use of data across biobanks based in Finland, Germany, the Netherlands, Norway and the UK. Our investigation starts with the analysis of the key differences for the use of data between these countries. As a result, we identified three key areas where legal requirements differ across the five BioSHaRE-EU jurisdictions, namely, in the definition of personal data, the requirements regarding pseudonymization and processing for medical research purposes. This article provides an overview of these differences and describes them in the light of the proposed EU regulation on data protection.

Caregiver and Adolescent Responses to Food and Beverage Marketing Exposures Through an Online Survey

The Institute of Medicine noted that current food and beverage marketing practices promote unhealthful diets. However, little public health research has been conducted on food marketing directed toward adolescents, especially using caregiver- and adolescent-reported data. We assessed perceived frequency of food/beverage advertising exposure and common locations of food/beverage marketing exposure for adolescents using 2012 Summer ConsumerStyles and YouthStyles survey data on US adults ≥18 years of age and their children ages 12-17 (n=847), respectively. Exposure to advertisements for fast food, soda, fruit drinks, sports drinks, energy drinks, and bottled water were categorized as <1 time/week, 1-6 times/week, and ≥1 time/day, and don't know. Weighted chi-square tests were used to examine the difference between caregivers' and adolescents' responses. The majority of caregivers and adolescents reported that adolescents viewed advertisements ≥1 time/day across all food/beverage categories with the highest, at least daily, exposure reported for fast food. Caregivers more frequently reported that adolescents viewed all food/beverage advertisements ≥1 time/day than the adolescents reported (chi-square tests, p<0.0001). Both caregivers and adolescents reported that the adolescents view food/beverage marketing most frequently on television followed by at the supermarket. Our study showed that adolescents reported lower frequency of food and beverage advertising exposure than their caregivers. Further research may be needed to verify self-reported exposure data on food and beverage advertising as a way to obtain data for use in research on its relationship with diet quality and obesity.

HydroDesktop: Web services-based software for hydrologic data discovery, download, visualization, and analysis

Discovering and accessing hydrologic and climate data for use in research or water management can be a difficult task that consumes valuable time and personnel resources. Until recently, this task required discovering and navigating many different data repositories, each having its own website, query interface, data formats, and descriptive language. New advances in cyberinfrastructure and in semantic mediation technologies have provided the means for creating better tools supporting data discovery and access. In this paper we describe a freely available and open source software tool, called HydroDesktop, that can be used for discovering, downloading, managing, visualizing, and analyzing hydrologic data. HydroDesktop was created as a means for searching across and accessing hydrologic data services that have been published using the Consortium of Universities for the Advancement of Hydrologic Science, Inc. (CUAHSI) Hydrologic Information System (HIS). We describe the design and architecture of HydroDesktop, its novel contributions in web services-based hydrologic data search and discovery, and its unique extensibility interface that enables developers to create custom data analysis and visualization plug-ins. The functionality of HydroDesktop and some of its existing plug-ins are introduced in the context of a case study for discovering, downloading, and visualizing data within the Bear River Watershed in Idaho, USA.

Validation of an Online Data Registry for Midwifery Practices: A Pilot Project

The value of a data registry for research, benchmarking, and quality improvement activities depends on the underlying quality of the data. This pilot study was conducted to design and implement a validation process assessing data quality in the American Association of Birth Centers' online data registry, the Uniform Data Set (UDS). Site visits were conducted in 5 midwifery practices attending births in freestanding birth centers and hospitals to compare data from health records with data in the registry. Practices meeting the inclusion criteria and representative of the overall population of midwifery practices contributing data to the UDS were audited. Between 2% and 5% of each practice's total UDS records were randomly selected and then compared with their matched health records for 29 key variables from the 189 variables in the UDS. A total of 3966 variables were reviewed for 152 records. There were 126 records for which complete maternity care was provided; thus, all 4 parts of the UDS were expected. There were 26 records for women who left care during pregnancy; thus, only parts 1 and 2 of the UDS were expected. Quality of the UDS data was evaluated, with the health records serving as the criterion standard, and the 2 sources were found to be consistent for 97.1% of the variables. Results from the study suggest that the data registry can provide valid data for use in research describing the process and outcomes of midwifery care and for benchmarking and quality improvement activities.

The 36th meeting of the Pay and Conditions Committee of the Union of Philosophers, Sages and Other Luminaries (UK University Branch)orDoping and proportionality

This article presents an analysis of current anti-doping practices through considerations of the ethical issues raised by the World Academic Standards Agency's proposal for an Academic Passport. It specifically analyses whether the modern anti-doping regime exhibits proportionality, whether it infringes privacy in relation to secondary research use of data and samples and whether it perpetuates a problematic notion of ‘thought crime’.

Development of alternative methods of data collection in South Asians with Type 2 diabetes

Previous research in the UK has established the difficulty of recruiting and collecting information from individuals whose main language is spoken and does not have an agreed written form. The aims of this study were (i) to develop culturally competent translations of two questionnaires measuring diabetes self-care in languages with no written form and to establish their face validity and (ii) to develop acceptable methods of delivery with the potential for providing valid and reliable data for use in research studies. Adults with Type 2 diabetes from two minority ethnic groups whose main language is spoken (Sylheti and Mirpuri) were recruited via the Birmingham Heartlands hospital diabetes centre. Participants were invited to attend five focus groups to consider the content and method of delivery of two questionnaires measuring knowledge of diabetes and confidence in diabetes self-care. Delivery methods were (i) pen and paper self-completion in Bengali/Urdu, (ii) pen and paper assisted completion in spoken language, (iii) partially-assisted completion in spoken language, (iv) independent audio delivery in spoken language. Culturally competent content was achieved for both questionnaires in both languages. The Mirpuri men and women's groups preferred assisted or partially assisted completion in spoken language. The Sylheti groups' preference was for independent audio delivery in spoken language. The face validity of two questionnaires measuring diabetes self-care is established for Sylheti and Mirpuri, in four alternative delivery formats. The questionnaires are now ready for psychometric testing in minority ethnic populations and the methods available for use by researchers to establish within-study feasibility.

Developing a strategy to reduce the high morbidity of patients with long-term urinary catheters: the BioMed catheter research clinic

To assess the idea of managing patients having problems with long-term catheterization (LTC, normally used when all other methods of bladder management have failed or are unsuitable) in a dedicated clinic, to present a prospective analysis of consecutive new patients attending between February 2002 and October 2006, and to establish the incidence of bladder stones in patients who have recurrent catheter encrustation and blockage. Patients treated with LTC are a large heterogeneous group, mainly consisting of elderly people who have chronic disabilities, and catheter-associated complications occur in > 70% of them. In all, 260 consecutive new patients having problems with LTC were assessed; the evaluation consisted of basic demographics, a detailed history, clinical examination, urine analysis and flexible cystoscopy (FC) via the catheterization route. Patients with bladder stones were screened with FC for recurrence of stones at 3, 6 and 12 months after treatment. In all, 117 men and 143 women (mean age 67.7 years, range 23-97) were assessed; 147 (55.5%) had catheter encrustation. FC showed that 66 of the 147 patients (45%) had bladder stones. Forty-eight patients (73%) were successfully treated at the same clinic appointment and their stones were removed with the help of a tip-less stone basket. Eighteen patients (27%) were referred for inpatient treatment of bladder stones under general anaesthesia. Twenty of 66 patients with bladder stones (30%) formed recurrent bladder stones at a mean (range) follow-up of 8.1 (3-18 months). In addition, 36 patients had successful insertion of suprapubic catheter (SPC) under local anaesthetic in the clinic, and 11 were referred for SPC insertion under general anaesthesia. Two patients were diagnosed with bladder transitional cell carcinoma. The introduction of a dedicated catheter clinic, equipped with facilities such as FC and a hoist, enables patients to be treated in an environment that meets their needs and potentially reduces the risk of more complex stone removal and catheter problems at a later date. It can also act as a potential source of data for use in research and development. A significant proportion (45%) of patients with catheter encrustation and blockage had formed bladder stones. Our study provides a rationale for FC of all such patients to detect and remove stones.

A Combined TOA/MDF Technology Upgrade of the U.S. National Lightning Detection Network

The U.S. National Lightning Detection NetworkTM (NLDN) has provided lightning data covering the continental United States since 1989. Using information gathered from more than 100 sensors, the NLDN provides both real‐time and historical lightning data to the electric utility industry, the National Weather Service, and other government and commercial users. It is also the primary source of lightning data for use in research and climatological studies in the United States. In this paper we discuss the design, implementation, and data from the time‐of‐arrival/magnetic direction finder (TOA/MDF) network following a recent system‐wide upgrade. The location accuracy (the maximum dimension of a confidence region around the stroke location) has been improved by a factor of 4 to 8 since 1991, resulting in a median accuracy of 500 m. The expected flash detection efficiency ranges from 80% to 90% for those events with peak currents above 5 kA, varying slightly by region. Subsequent strokes and strokes with peak currents less than 5 kA can now be detected and located; however, the detection efficiency for these events is not quantified in this study because their peak current distribution is not well known.

Epidemiological research needs access to data.

Data protection laws and their implementation have led to serious restrictions on access to personal data for research purposes. This seriously affects the development of social medicine and public health by making effective prevention of illness, and rational planning of health services, and their evaluation impossible in many instances. The conflict between people's need for knowledge about prevention and cure of illness and the control over personal data must be solved. Therefore, it is necessary to change the laws and ensure access to data for research use in accordance with the guidelines laid down by the European Science Foundation.

A PRELIMINARY DESCRIPTION AND FACTOR ANALYSIS OF A BROAD SPECTRUM BATTERY FOR ASSESSING ‘PROGRESS TOWARD READING MATURITY’

The study of reading behavior is presumed to be arrested by low‐risk instrumentation. A battery is described which was assembled to advance study and definition of reading maturity. The battery is shown, by factor analysis, to have greater implicit construct similarity to a popular taxonomy and diagnostic system than conventional measures typically address. Suggestion for the wider use of such paradigms for assessment are shown to yield qualitatively richer data for use in research than current conventions tend to provide.