Dataset Information

Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users.

ABSTRACT: To characterise experiences using clinical research data shared through the National Institutes of Health (NIH)'s Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) clinical research data repository, along with data recipients' perceptions of the value, importance and challenges with using BioLINCC data.Cross-sectional web-based survey.All investigators who requested and received access to clinical research data from BioLINCC between 2007 and 2014.Reasons for BioLINCC data request, research project plans, interactions with original study investigators, BioLINCC experience and other project details.There were 536 investigators who requested and received access to clinical research data from BioLINCC between 2007 and 2014. Of 441 potential respondents, 195 completed the survey (response rate=44%); 89% (n=174) requested data for an independent study, 17% (n=33) for pilot/preliminary analysis. Commonly cited reasons for requesting data through BioLINCC were feasibility of collecting data of similar size and scope (n=122) and insufficient financial resources for primary data collection (n=76). For 95% of respondents (n=186), a primary research objective was to complete new research, as opposed to replicate prior analyses. Prior to requesting data from BioLINCC, 18% (n=36) of respondents had contacted the original study investigators to obtain data, whereas 24% (n=47) had done so to request collaboration. Nearly all (n=176; 90%) respondents found the data to be suitable for their proposed project; among those who found the data unsuitable (n=19; 10%), cited reasons were data too complicated to use (n=5) and data poorly organised (n=5). Half (n=98) of respondents had completed their proposed projects, of which 67% (n=66) have been published.Investigators were primarily using clinical research data from BioLINCC for independent research, making use of data that would otherwise have not been feasible to collect.

SUBMITTER: Ross JS

PROVIDER: S-EPMC5051517 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users.

Ross Joseph S JS Ritchie Jessica D JD Finn Emily E Desai Nihar R NR Lehman Richard L RL Krumholz Harlan M HM Gross Cary P CP

BMJ open 20160926 9

<h4>Objective</h4>To characterise experiences using clinical research data shared through the National Institutes of Health (NIH)'s Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) clinical research data repository, along with data recipients' perceptions of the value, importance and challenges with using BioLINCC data.<h4>Design and setting</h4>Cross-sectional web-based survey.<h4>Participants</h4>All investigators who requested and received access to clinical re ...[more]

PMID: 27670522

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Project description:BackgroundCalls have been made for increased access to individual participant data (IPD) from clinical trials, to ensure that complete evidence is available. However, despite the obvious benefits, progress towards this is frustratingly slow. In the meantime, many systematic reviews have already collected IPD from clinical trials. We propose that a central repository for these IPD should be established to ensure that these datasets are safeguarded and made available for use by others, building on the strengths and advantages of the collaborative groups that have been brought together in developing the datasets.ObjectiveEvaluate the level of support, and identify major issues, for establishing a central repository of IPD.DesignOn-line survey with email reminders.Participants71 reviewers affiliated with the Cochrane Collaboration's IPD Meta-analysis Methods Group were invited to participate.Results30 (42%) invitees responded: 28 (93%) had been involved in an IPD review and 24 (80%) had been involved in a randomised trial. 25 (83%) agreed that a central repository was a good idea and 25 (83%) agreed that they would provide their IPD for central storage. Several benefits of a central repository were noted: safeguarding and standardisation of data, increased efficiency of IPD meta-analyses, knowledge advancement, and facilitating future clinical, and methodological research. The main concerns were gaining permission from trial data owners, uncertainty about the purpose of the repository, potential resource implications, and increased workload for IPD reviewers. Restricted access requiring approval, data security, anonymisation of data, and oversight committees were highlighted as issues under governance of the repository.ConclusionThere is support in this community of IPD reviewers, many of whom are also involved in clinical trials, for storing IPD in a central repository. Results from this survey are informing further work on developing a repository of IPD which is currently underway by our group.

Project description:BACKGROUND:A number of research funders, biomedical journals, pharmaceutical companies, and regulatory agencies have adopted policies advocating or mandating that clinical trialists share data with external investigators. We therefore sought to determine whether certain characteristics of trialists or their trials are associated with more unfavorable perceptions of data sharing. To date, no prior research has addressed this issue. METHODS:We conducted an exploratory analysis of responses to a cross-sectional, web-based survey. The survey sample consisted of trialists who were corresponding authors of clinical trials published in 2010 or 2011 in one of six general medical journals with the highest impact factors in 2011. The following key characteristics were examined: trialists' academic productivity and geographic location, trial funding source and size, and the journal in which it was published. Main outcome measures included: support for data sharing in principle, concerns with data sharing through repositories, and reasons for granting or denying requests. Chi-squared tests and Fisher's exact tests were used to assess statistical significance. RESULTS:Of 683 potential respondents, 317 completed the survey (response rate 46%). Both support for data sharing and reporting of specific concerns with sharing data through repositories exceeded 75%, but neither differed by trialist or trial characteristics. However, there were some significant differences in explicit reasons to share or withhold data. Respondents located in Western Europe more frequently indicated they have or would share data in order to receive academic benefits or recognition when compared with respondents located in the United States or Canada (58 versus 31%). In addition, respondents who were the most academically productive less frequently indicated they have or would withhold data in order to protect research subjects when compared with less academically productive respondents (24 versus 40%), as did respondents who received industry funding when compared with those who had not (24 versus 43%). CONCLUSIONS:Respondents indicated strong support for data sharing overall. There were few notable differences in how trialists viewed the benefits and risks of data sharing when categorized by trialists' academic productivity and geographic location, trial funding source and size, and the journal in which it was published.

Project description:BackgroundThere has been significant effort in attempting to use health care data. However, laws that protect patients' privacy have restricted data use because health care data contain sensitive information. Thus, discussions on privacy laws now focus on the active use of health care data beyond protection. However, current literature does not clarify the obstacles that make data usage and deidentification processes difficult or elaborate on users' needs for data linking from practical perspectives.ObjectiveThe objective of this study is to investigate (1) the current status of data use in each medical area, (2) institutional efforts and difficulties in deidentification processes, and (3) users' data linking needs.MethodsWe conducted a cross-sectional online survey. To recruit people who have used health care data, we publicized the promotion campaign and sent official documents to an academic society encouraging participation in the online survey.ResultsIn total, 128 participants responded to the online survey; 10 participants were excluded for either inconsistent responses or lack of demand for health care data. Finally, 118 participants' responses were analyzed. The majority of participants worked in general hospitals or universities (62/118, 52.5% and 51/118, 43.2%, respectively, multiple-choice answers). More than half of participants responded that they have a need for clinical data (82/118, 69.5%) and public data (76/118, 64.4%). Furthermore, 85.6% (101/118) of respondents conducted deidentification measures when using data, and they considered rigid social culture as an obstacle for deidentification (28/101, 27.7%). In addition, they required data linking (98/118, 83.1%), and they noted deregulation and data standardization to allow access to health care data linking (33/98, 33.7% and 38/98, 38.8%, respectively). There were no significant differences in the proportion of responded data needs and linking in groups that used health care data for either public purposes or commercial purposes.ConclusionsThis study provides a cross-sectional view from a practical, user-oriented perspective on the kinds of data users want to utilize, efforts and difficulties in deidentification processes, and the needs for data linking. Most users want to use clinical and public data, and most participants conduct deidentification processes and express a desire to conduct data linking. Our study confirmed that they noted regulation as a primary obstacle whether their purpose is commercial or public. A legal system based on both data utilization and data protection needs is required.

Project description:ObjectivesTo gather knowledge on the current debate, opinions and attitudes of Italian patient and citizen groups on individual participant data (IPD) sharing from clinical studies.DesignCross-sectional online survey.Setting and participantsA 22-item online questionnaire was sent by email to 2003 contacts of patient and citizen groups in Italy. We received 311 responses, checked for duplicate respondents (16); 295 single groups responded, 280 providing questionnaires eligible for analysis (response rate 15%). Ninety (32.1%) dealt with oncology and palliative care, 175 (46.2%) operated locally or regionally and 136 (48.6%) were involved in clinical research.Outcome measureData on Italian patient and citizen groups' self-reported knowledge, attitudes and opinions on IPD sharing, mechanisms for IPD access, advantages and risks.ResultsHalf the respondents (144 out of 280, 51%) had some knowledge about the IPD sharing debate, and 60 (42%) stated they had an official position (35 in favour, 19 in favour with restrictions, 2 against, 1 neither for nor against, 3 missing). Nineteen discussed the topic encouraged by this survey; 39% approved broad access by researchers and other professions and identified information to participants, data de-identification, secure archives, access agreements and sanctions for misuse as important aspects of IPD sharing models. Respondents highlighted re-identification, privacy and re-use of data for purposes that participants do not agree on, as main risks, advancement of innovation and reducing waste in research as main advantages. Around half believed IPD sharing would not discourage study participation.ConclusionsHalf the respondents were aware of the debate. Those who had an official position were mainly in favour of IPD sharing. Many supported broad access, asking for conditions important for building trust in entities that handle IPD sharing.Although limited by the low response rate, these findings reinforce the demand for reliable and transparent processes where accountabilities are clear.

Project description:BACKGROUND:The Public Private Interface-Electronic Patient Record (PPI-ePR) system was implemented as a new electronic platform to facilitate collaboration between the public and private sectors in Hong Kong. However, its barriers to participate and benefits have not been comprehensively assessed. OBJECTIVE:This study aimed to evaluate the awareness, acceptance, perceived benefits, and obstacles to participation among private doctors and the general public. METHODS:From December 2012 to January 2013, 2435 telephone interviews were performed by trained interviewers to survey randomly selected patients who were enrolled or not enrolled in the PPI-ePR system. In addition, self-administered surveys were sent by postal mail to 4229 registered doctors in Hong Kong. The questionnaires for both patients and doctors contained questions on subjects' awareness, acceptance, and perceptions of the PPI-ePR, perceived benefits and obstacles of participating in the program, reasons for not using the system after enrolling, and perceived areas for service improvement of the system. RESULTS:More than 53.1% (266/501) of enrolled patients believed that the PPI-ePR system would improve health care quality by reducing duplicate tests and treatments, while more than 76.8% (314/409) of enrolled doctors emphasized timely access to patients' medical records as the biggest benefit of their enrollment. Among nonenrolled patients, unawareness of the project was the most popular obstacle to enrolling in the PPI-ePR system (483/1200, 40.3%). Regarding nonenrolled doctors, the complicated registration process hindered them from participating in the program the most (95/198, 48.0%). Television, newspaper, and magazine advertisements and medical profession newsletters or journals were suggested as the most effective means to encourage participation in the program among surveyed patients (1297/1701, 76.2%) and doctors (428/610, 70.2%), respectively. Lack of clinical indication requiring data extraction from other hospitals was the main reason for low level of PPI-ePR use. CONCLUSIONS:This study comprehensively assessed the popularity, perceived benefits, and hindering factors of enrolling in the PPI-ePR system in Hong Kong. Low levels of awareness, few privacy concerns, and inactive use of the PPI-ePR system were among the key features for patients and physicians. Public promotions, simplified logistics, and a user-friendly online interface were suggested to improve the coverage and effectiveness of health information exchange between private and public health care sectors.

Dataset Information

Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users.

Publications

Data sharing through an NIH central database repository: a cross-sectional survey of BioLINCC users.

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