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Karim Keshavjee

Publications and source records attributed to Karim Keshavjee.

5 recordsLinked to original sources
PubMed2005

Can current electronic systems meet drug safety and effectiveness requirements?

BACKGROUND: Every health policy jurisdiction is endeavoring to enhance its ability to evaluate drug effectiveness, safety and cost in the real world (pharmacosurveillance). METHODS: A nominal group consensus conference of stakeholders finalized data items deemed necessary for pharmacosurveillance. Large administrative datasets (LADs), electronic health records (EHRs) and electronic patient registries (PRs), were investigated as sources of this information and for their vulnerability to methodologic bias. Health data privacy legislation and research guidelines were systematically reviewed for their constraint to linked data resource analyses. RESULTS: More than 129 data items were strongly recommended for routine pharmacosurveillance. LADs had very complete information, but restricted to a small number of required data items. EHRs, especially with e-pharmacy links, offer by far the most complete set of health information domains but data entry completeness is highly variable. Adjustment methods for channeling bias are inadequate to mimic randomized trials. Anonymized, linked data held within a secure academic research environment, poses the least privacy concerns. CONCLUSIONS: Notwithstanding major technical, methodologic and privacy challenges, individual-level linkage of health data resources poses the best option for pharmacosurveillance today. In future, drug regulators and reimbursement agencies should consider mandatory post-marketing randomized trials.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Patients' consent preferences regarding the use of their health information for research purposes: a qualitative study.

OBJECTIVE: To explore the consent preferences of patients whose health data are currently being used for research purposes. METHODS: Semi-structured interviews were conducted with 17 patients whose primary physicians were taking part in a study that utilized de-identified individual-level health information from their electronic medical record. All physicians practised in southwestern Ontario. All interviews were taped, transcribed verbatim and analysed using a constant comparative method. All transcripts and debriefing notes were read and reread to elicit general themes. RESULTS: Three main themes emerged from the data: patients recognized the need to balance their consent preferences with time pressures in the clinical encounter when deciding the nature of consent for a study; patients generally regarded the seeking of consent as being an issue of respect for them as individuals; and patients were also weighing their perceived benefits and concerns related to the research. For these patients, seeking their consent was an important step in research participation. For some patients, the sponsor and the research topic were factors that would influence their decision to provide consent. CONCLUSION: Patients want their consent to be sought when their data are used for research purposes. This will involve explicitly informing patients that a study is taking place, providing written consent and offering regular updates about the study.

Access to Information↗
PubMed2003

Patients' consent preferences for research uses of information in electronic medical records: interview and survey data.

OBJECTIVES: To assess patients' preferred method of consent for the use of information from electronic medical records for research. DESIGN: Interviews and a structured survey of patients in practices with electronic medical records. SETTING: Family practices in southern Ontario, Canada. PARTICIPANTS: 123 patients: 17 were interviewed and 106 completed a survey. MAIN OUTCOME MEASURES: Patients' opinions and concerns on use of information from their medical records for research and their preferences for method of consent. RESULTS: Most interviewees were willing to allow the use of their information for research purposes, although the majority preferred that consent was sought first. The seeking of consent was considered an important element of respect for the individual. Most interviewees made little distinction between identifiable and anonymised data. Research sponsored by private insurance firms generated the greatest concern, and research sponsored by foundation the least. Sponsorship by drug companies evoked negative responses during interview and positive responses in the survey. CONCLUSIONS: Patients are willing to allow information from their medical records to be used for research, but most prefer to be asked for consent either verbally or in writing.

Access to Information↗
PubMed2003

Applying methodology to electronic medical record selection.

BACKGROUND: Given the potential for electronic medical records (EMRs) to influence every aspect of health care, there has been surprisingly little rigorous research applied to this emerging health technology. An initial phase of the COMPETE (computerization of medical practices for the enhancement of therapeutic efficacy) program, which investigates the impact of EMRs and electronic decision support on efficiency, quality of care and privacy concerns, developed and used a rigorous approach to EMR selection. METHODS: A multidisciplinary team with clinical, technical and research expertise led an eight-stage evaluation process with direct input from potential clinical users at each stage. An iterative sequence of review of EMR specifications and features, live product demonstrations, site visits, and negotiations with vendors led to a progressive narrowing of the field of eligible EMR systems. Final scoring was based on three main themes of clinical usability, data quality and vendor maturity issues. RESULTS: The field of eligible EMR systems was relatively easily narrowed to a few finalists. Determination of the important strengths and weaknesses of these systems' usability, data extraction capabilities and vendor viability, required the full suite of evaluation steps. Preferences varied amongst clinicians and between clinicians and technical specialists, particularly regarding the importance of user interface versus database issues. However, the final scoring process showed consensus amongst clinical and technical experts. CONCLUSION: A rigorous, multidisciplinary process is useful in EMR selection. While prolonged and laborious, it is transparent, enhances buy in and realism of expectations by multiple potential users and IT support staff and may, therefore, improve the ultimate success of any EMR implementation project.

Computer Systems↗