Data safety and monitoring for research involving remote health monitoring

Telemedicine and e-Health

Volumn 17, Issue 7, 2011, Pages 574-579

  Kovach, Karen A ^a   Aubrecht, Jill Ann ^a   Dew, Mary Amanda ^a   Myers, Brad ^b   Dabbs, Annette DeVito ^a  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b CARNEGIE MELLON UNIVERSITY   (United States)

Author keywords

data safety and monitoring; exemplar; human subject protection; Pocket PATH ; remote health monitoring

Indexed keywords

ADVERSE EVENTS; CLINICAL DATA; DATA SAFETY AND MONITORING; EXEMPLAR; FEDERAL REGULATIONS; HEALTH MONITORING; HEALTH PROJECTS; HUMAN SUBJECTS; ON-GOING MONITORING; PERSONAL ASSISTANTS; PRACTICAL GUIDANCE; REMOTE HEALTH MONITORING; SAFETY MONITORING; WELLBEING;

HEALTH; INVESTMENTS; RESEARCH; SECURITY OF DATA;

PATIENT MONITORING;

ARTICLE; COMPUTER SECURITY; CONFIDENTIALITY; ELECTRONIC MEDICAL RECORD; ETHICS; HUMAN; HUMAN EXPERIMENT; MEDICAL INFORMATICS; STANDARD; TELECONSULTATION;

COMPUTER SECURITY; CONFIDENTIALITY; ELECTRONIC HEALTH RECORDS; HUMAN EXPERIMENTATION; HUMANS; MEDICAL INFORMATICS; REMOTE CONSULTATION;

EID: 80052011968     PISSN: 15305627     EISSN: 15563669     Source Type: Journal    
DOI: 10.1089/tmj.2010.0219     Document Type: Review

References (14)

1. ACM (Association of Computing Machinery). ACM code of ethics and professional conduct. Commun ACM 1993;36:99-103.
2. American Psychological Association. Ethical principles of psychologists and code of conduct. 1992. Available at www.apa.org/ethics/code.html (last accessed January 28, 2010).
3. AoIR (Association of Internet Researchers) AoIR Ethics Working Committee. Ethical decision making and internet research. 2002. Available at www cddc.vt.edu/aoir/ethics/public/draftthree.html (last accessed January 28, 2010).
4. Frankel MS, Siang S. Ethical and legal aspects of human subjects research on the internet: A report of a workshop June 10-11, 1999. American Association for the Advancement of Science (AAAS). 1999. Available at www.aaas.org/spp/ sfrl/projects/intres/report.pdf (last accessed January 15, 2010).
5. Brownsell S, Blackburn S, Hawley MS. An evaluation of second and third generation telecare services in older people's housing. J Telemed Telecare 2008;14:8-12.
6. Conley EC, Owens DR, Luzio SL, Subramanian M, Ali AS, Hardisty A, Rana O. Simultaneous trend analysis for evaluating outcomes in patient-centered health monitoring services. Health Care Manag Sci 2008;11:152-166.
7. Dabbs Ade V, Myers B, McCurry K, Dunbar-Jacob J, Hawkins R, Begey A, Dew MA. User-centered design and interactive health technologies for patients. Comput Inform Nurs 2009;27:175-183.
8. Dabbs Ade V, Dew MA, Meyers B, Begey A, Hawkins R, Ren D, Dunbar-Jacob J, Oconnell E, McCurry KR. Evaluation of a hand-held, computer-based interventions to promote early self-care behaviors after lung transplant. Clin Transpl 2009;23:537-545.
9. Sim J, Wright C. The Kappa Statistic in reliability studies: Use, interpretation, and sample size requirements. Phys Ther 2005;85:257-268.
10. Goldberg LR, Piette JD, Walsh MN, Frank TA, Jaski BE, Smith AL, Rodriguez R, Mancini, DM, Hopton LA, Orav EJ, Loh E. Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure: The weight monitoring in heart failure (WHARF) trial. Am Heart J 2003;146:705-712.
11. Rogers MAM, Small D, Buchan DA, Butch CA, Stewart CM, Krenzer BE, Husovsky HL. Home monitoring service improves mean arterial pressure in patients with essential hypertension. Ann Intern Med 2001;134:1024-1032.
12. Finkelstein J, Cabrera MR, Hripcsak G. Internet-based home asthma telemonitoring. Chest J 2000;148-155. Available at www.chestjournal.org (last accessed May 11, 2009).
13. Christensen H, Griffiths KM, Jorm AF. Delivering interventions for depression by using the Internet: Randomized controlled trial. BMJ 2004;328:265-267.
14. Hoek W, Schuurmans J, Koot HM, Cuijpers P. Prevention of depression and anxiety in adolescents: A randomized controlled trial testing the efficacy and mechanisms of Internet-based self-help problem-solving therapy. Trials 2009;10:93.