scholarly journals Automatic Placement of Genomic Research Results in Medical Records: Do Researchers Have a Duty? Should Participants Have a Choice?

2015 ◽  
Vol 43 (4) ◽  
pp. 827-842
Author(s):  
Anya E.R. Prince ◽  
John M. Conley ◽  
Arlene M. Davis ◽  
Gabriel Lázaro-Muñoz ◽  
R. Jean Cadigan
Keyword(s):  
Medical Record ◽  
Medical Records ◽  
Genomic Research ◽  
Research Results ◽  
Research Participants ◽  
Difficult Question ◽  
Automatic Placement ◽  
Study Participants ◽  
Research Studies

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored.

A Literature Review of Medical Record Keeping by Foreign Medical Teams in Sudden Onset Disasters

2015 ◽  
Vol 30 (2) ◽  
pp. 216-222 ◽  
Author(s):  
Anisa J. N. Jafar ◽  
Ian Norton ◽  
Fiona Lecky ◽  
Anthony D. Redmond
Keyword(s):  
Literature Review ◽  
Medical Record ◽  
Medical Records ◽  
Sudden Onset ◽  
World Health ◽  
Publication Type ◽  
Data Set ◽  
Record Keeping ◽  
Medical Teams

AbstractBackgroundMedical records are a tenet of good medical practice and provide one method of communicating individual follow-up arrangements, informing research data, and documenting medical intervention.MethodsThe objective of this review was to look at one source (the published literature) of medical records used by foreign medical teams (FMTs) in sudden onset disasters (SODs). The published literature was searched systematically for evidence of what medical records have been used by FMTs in SODs.FindingsThe style and content of medical records kept by FMTs in SODs varied widely according to the published literature. Similarly, there was great variability in practice as to what happens to the record and/or the data from the record following its use during a patient encounter. However, there was a paucity of published work comprehensively detailing the exact content of records used.InterpretationWithout standardization of the content of medical records kept by FMTs in SODs, it is difficult to ensure robust follow-up arrangements are documented. This may hinder communication between different FMTs and local medical teams (LMTs)/other FMTs who may then need to provide follow-up care for an individual. Furthermore, without a standard method of reporting data, there is an inaccurate picture of the work carried out. Therefore, there is not a solid evidence base for improving the quality of future response to SODs. Further research targeting FMTs and LMTs directly is essential to inform any development of an internationally agreed minimum data set (MDS), for both recording and reporting, in order that FMTs can reach the World Health Organization (WHO) standards for FMT practice.JafarAJN, NortonI, LeckyF, RedmondAD. A literature review of medical record keeping by foreign medical teams in sudden onset disasters. Prehosp Disaster Med. 2015;30(2):1-7.

scholarly journals Effect of Public Deliberation on Patient Attitudes Regarding Consent and Data Use in a Learning Health Care System for Oncology

2019 ◽  
Vol 37 (34) ◽  
pp. 3203-3211 ◽  
Author(s):  
Reshma Jagsi ◽  
Kent A. Griffith ◽  
Rochelle D. Jones ◽  
Chris Krenz ◽  
Michele Gornick ◽  
...  
Keyword(s):  
Health Care ◽  
Medical Record ◽  
Medical Records ◽  
Health Care Systems ◽  
Insurance Companies ◽  
Future Research ◽  
Democratic Deliberation ◽  
Recommended Care ◽  
Care Systems

PURPOSE We sought to generate informed and considered opinions regarding acceptable secondary uses of deidentified health information and consent models for oncology learning health care systems. METHODS Day-long democratic deliberation sessions included 217 patients with cancer at four geographically and sociodemographically diverse sites. Patients completed three surveys (at baseline, immediately after deliberation, and 1-month follow-up). RESULTS Participants were 67.3% female, 21.7% black, and 6.0% Hispanic. The most notable changes in perceptions after deliberation related to use of deidentified medical-record data by insurance companies. After discussion, 72.3% of participants felt comfortable if the purpose was to make sure patients receive recommended care ( v 79.5% at baseline; P = .03); 24.9% felt comfortable if the purpose was to determine eligibility for coverage or reimbursement ( v 50.9% at baseline; P < .001). The most notable change about secondary research use related to believing it was important that doctors ask patients at least once whether researchers can use deidentified medical-records data for future research. The proportion endorsing high importance decreased from baseline (82.2%) to 68.7% immediately after discussion ( P < .001), and remained decreased at 73.1% ( P = .01) at follow-up. At follow-up, non-Hispanic whites were more likely to consider it highly important to be able to conduct medical research with deidentified electronic health records (96.8% v 87.7%; P = .01) and less likely to consider it highly important for doctors to get a patient’s permission each time deidentified medical record information is used for research (23.2% v 51.6%; P < .001). CONCLUSION This research confirms that most patients wish to be asked before deidentified medical records are used for research. Policies designed to realize the potential benefits of learning health care systems can, and should be, grounded in informed and considered public opinion.

scholarly journals Practices and Attitudes toward Returning Genomic Research Results to Low-Resource Research Participants

2021 ◽  
pp. 1-12
Author(s):  
Megan B. Raymond ◽  
Kayla E. Cooper ◽  
Lisa S. Parker ◽  
Vence L. Bonham
Keyword(s):  
Low Income ◽  
Clinical Care ◽  
Genomic Research ◽  
Research Results ◽  
Low Resource ◽  
Research Participants ◽  
Research Programs ◽  
Ancillary Care ◽  
Genomic Results ◽  
Resource Research

<b><i>Introduction:</i></b> Many research programs are challenged to accommodate low-resource research participants’ (LRRP) ancillary care needs when returning genomic research results. We define LRRP as those who are low income, uninsured, underinsured, or facing barriers to act upon the results returned. This study evaluates current policies and practices surrounding return of results (RoR) to LRRP, as well as the attitudes of investigators toward providing ancillary care to LRRP. <b><i>Methods:</i></b> A semi-structured interview study was conducted with representatives of 35 genomic research programs nationwide. Eligible programs were returning, or planning to return, medically actionable genomic results to participants. <b><i>Results:</i></b> Three content categories emerged from this study, including: (1) RoR structures, (2) barriers to RoR to LRRP, and (3) solutions to meet community and LRRP needs. Three major structures of RoR emerged: (1) RoR Embedded in Clinical Care, (2) RoR Independent of Clinical Care, and (3) Reliance on Clinical Partnerships to Facilitate RoR. Inadequacy of program resources to address the needs of LRRP was commonly considered a significant obstacle. The attitudes and views of informants regarding responsibility to provide ancillary care for LRRP receiving genomic results were highly varied. Some informants believed that genomic sequencing and testing was not a priority for LRRP because of other pressing issues in their lives, such as housing and food insecurity. Research programs differ regarding whether clinical and social support for LRRP is considered within the purview of the research team. Some programs instituted accommodations for LRRP, including social work referral and insurance enrollment assistance. <b><i>Conclusion:</i></b> Support to access downstream treatment is not readily available for LRRP in many genomic research programs. Development of best practices and policies for managing RoR to LRRP is needed.

scholarly journals Pragmatic Tools for Sharing Genomic Research Results with the Relatives of Living and Deceased Research Participants

2018 ◽  
Vol 46 (1) ◽  
pp. 87-109 ◽  
Author(s):  
Susan M. Wolf ◽  
Emily Scholtes ◽  
Barbara A. Koenig ◽  
Gloria M. Petersen ◽  
Susan A. Berry ◽  
...  
Keyword(s):  
Pediatric Research ◽  
Genomic Research ◽  
Return Of Results ◽  
Exploratory Research ◽  
Clinical Sequencing ◽  
Research Results ◽  
Participant Preferences ◽  
Author Group ◽  
Flow Charts

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research (CSER) Consortium. The authors then negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death.

Accuracy of Healthcare Worker Recall and Medical Record Review for Identifying Infectious Exposures to Hospitalized Patients

2006 ◽  
Vol 27 (7) ◽  
pp. 722-728 ◽  
Author(s):  
M. Aquino ◽  
J. M. Raboud ◽  
A. McGeer ◽  
K. Green ◽  
R. Chow ◽  
...  
Keyword(s):  
Medical Record ◽  
Healthcare Worker ◽  
Medical Records ◽  
Medical Record Review ◽  
Contact Tracing ◽  
Surgical Intensive Care Unit ◽  
Surgical Intensive Care ◽  
Memory Aids ◽  
Record Review

Objective.To determine the validity of using healthcare worker (HCW) recall of patient interactions and medical record review for contact tracing in a critical care setting.Design.Trained observers recorded the interactions of nurses, respiratory therapists, and service assistants with study patients in a medical-surgical intensive care unit. These observers' records were used as the reference standard to test the criterion validity of using HCW recall data or medical record review data to identify exposure characteristics. We assessed the effects of previous quarantine of the HCW (because of possible exposure) and the availability of patients' medical records for use as memory aids on the accuracy of HCW recall.Setting.A 10-bed medical-surgical intensive care unit at Mount Sinai Hospital in Toronto, Ontario.Patients.Thirty-six HCWs observed caring for 16 patients, for a total of 55 healthcare worker shifts.Results.Recall accuracy was better among HCWs who were provided with patient medical records as memory aids (P<.01). However, HCWs tended to overestimate exposures when they used patient medical records as memory aids. For 6 of 26 procedures or care activities, this tendency to overestimate was statistically significant (P<.05). Most HCWs with true exposures were identified by means of this technique, despite the overestimations. Documentation of the activities of the 4 service assistants could not be found in any of the patients' medical records. Similarly, the interactions between 6 (19%) of 32 other patient–HCW pairs were not recorded in patients' medical records.Conclusions.Data collected from follow-up interviews with HCWs in which they are provided with patient medical records as memory aids should be adequate for contact tracing and for determining exposure histories. Neither follow-up interviews nor medical record review alone provide sufficient data for these purposes.

scholarly journals Electronic Surveillance of Testicular Cancer: Understanding Patient Perspectives on Access to Electronic Medical Records

2009 ◽  
Vol 5 (4) ◽  
pp. 177-181 ◽  
Author(s):  
Ryan J. Groll ◽  
Kevin J. Leonard ◽  
Joan Eakin ◽  
Padraig Warde ◽  
Jackie Bender ◽  
...  
Keyword(s):  
Testicular Cancer ◽  
Medical Record ◽  
Electronic Medical Records ◽  
Medical Records ◽  
Early Stage ◽  
Reference Source ◽  
Medical Record Data ◽  
Electronic Medical Record Data ◽  
Record Data

This study explores the basis for providing effective access to electronic medical record data as a reference source for patients with early-stage testicular cancer undergoing surveillance follow-up programs.

scholarly journals Recommendations for the Return of Research Results to Study Participants and Guardians: A Report From the Children's Oncology Group

2012 ◽  
Vol 30 (36) ◽  
pp. 4573-4579 ◽  
Author(s):  
Conrad V. Fernandez ◽  
Kathleen Ruccione ◽  
Robert J. Wells ◽  
Jay B. Long ◽  
Wendy Pelletier ◽  
...  
Keyword(s):  
Task Force ◽  
Return Of Results ◽  
Personal Contact ◽  
Oncology Group ◽  
Cooperative Research ◽  
Group Setting ◽  
Research Results ◽  
Research Participants ◽  
Study Results ◽  
Study Participants

Purpose The Children's Oncology Group (COG) strongly supports the widely recognized principle that research participants should be offered a summary of study results. The mechanism by which to do so in a cooperative research group setting has not been previously described. Methods On the basis of a review of the available empirical and theoretic literature and on iterative, multidisciplinary discussion, a COG Return of Results Task Force (RRTF) offered detailed recommendations for the return of results to research study participants. Results The RRTF established guidelines for the notification of research participants and/or their parents/guardians about the availability of research results, a mechanism for and timing of sharing results via registration on the COG public Web site, the scope of the research to be shared, the target audience, and a process for creating and vetting lay summaries of study results. The RRTF recognized the challenges in adequately conveying complex scientific results to audiences with varying levels of health literacy and recommended that particularly sensitive or complex results be returned using direct personal contact. The RRTF also recommended evaluation of the cost, effectiveness, and impact of sharing results. Conclusion These recommendations provide a framework for the offering and returning of results to participants. They can be used by individual investigators, multi-investigator research collaboratives, and large cooperative groups.

scholarly journals Text messaging research participants as a follow-up strategy to decrease emergency department study attrition

CJEM ◽  
2017 ◽  
Vol 20 (1) ◽  
pp. 148-153 ◽  
Author(s):  
Catherine Varner ◽  
Shelley McLeod ◽  
Negine Nahiddi ◽  
Bjug Borgundvaag
Keyword(s):  
Emergency Department ◽  
Randomized Trial ◽  
Text Messaging ◽  
Text Message ◽  
Text Messages ◽  
Communication Strategy ◽  
Research Participants ◽  
Patient Reported ◽  
Study Participants

AbstractObjectiveCollecting patient-reported follow-up data for prospective studies in the emergency department (ED) is challenging in this minimal continuity setting. The objective of this study was to determine whether text messaging study participants involved in an ongoing randomized trial resulted in a lower rate of attrition as compared to conventional telephone follow-up.MethodsThis was a nested cohort analysis of research participants enrolled in a randomized controlled trial assessing head injury discharge instructions. During the first 4 months of study follow-up, participants were contacted by a conventional telephone call. For the final 3 months, participants were contacted by text messaging following the first failed telephone attempt.ResultsA total of 118 patients were enrolled in the study (78 underwent conventional follow-up, and 40 received text messages). During the period of conventional follow-up, 3 participants withdrew from the study. Of the remaining 75 participants, 24 (32.0%) at 2 weeks and 32 (42.7%) at 4 weeks were unable to be contacted. Of the 40 participants receiving a reminder text message, 4 (10.0%) at 2 weeks and 10 (25.0%) at 4 weeks were unable to be contacted. Overall, text messaging study participants decreased attrition by 22% (95% CI: 5.9%, 34.7%) and 17.7% (95% CI: -0.8%, 33.3%) at 2- and 4-week follow-ups, respectively.ConclusionsIn this ED cohort participating in a randomized trial, text message reminders of upcoming telephone follow-up interviews decreased the rate of attrition. Text messaging is a viable, low-cost communication strategy that can improve follow-up participation in prospective research studies.

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