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      Written informed consent and selection bias in observational studies using medical records: systematic review

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          Abstract

          Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies.

          Design Systematic review.

          Data sources Embase, Medline, and the Cochrane Library up to March 2008, reference lists from pertinent articles, and searches of electronic citations.

          Study selection Prospective observational studies reporting characteristics of participants and non-participants approached for informed consent to use their medical records. Studies were selected independently in duplicate; a third reviewer resolved disagreements.

          Data extraction Age, sex, race, education, income, or health status of participants and non-participants, the participation rate in each study, and susceptibility of these calculations to threats of selection and reporting bias.

          Results Of 1650 citations 17 unique studies met inclusion criteria and had analysable data. Across all outcomes there were differences between participants and non-participants; however, there was a lack of consistency in the direction and the magnitude of effect. Of 161?604 eligible patients, 66.9% consented to use of data from their medical records.

          Conclusions Significant differences between participants and non-participants may threaten the validity of results from observational studies that require consent for use of data from medical records. To ensure that legislation on privacy does not unduly bias observational studies using medical records, thoughtful decision making by research ethics boards on the need for mandatory consent is necessary.

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          Most cited references11

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          Quality of reporting of observational longitudinal research.

          Observational longitudinal research is particularly useful for assessing etiology and prognosis and for providing evidence for clinical decision making. However, there are no structured reporting requirements for studies of this design to assist authors, editors, and readers. The authors developed and tested a checklist of criteria related to threats to the internal and external validity of observational longitudinal studies. The checklist criteria concerned recruitment, data collection, biases, and data analysis and descriptive issues relevant to study rationale, study population, and generalizability. Two raters independently assessed 49 randomly selected articles describing stroke research published from 1999 to 2003 in six journals: American Journal of Epidemiology, Journal of Epidemiology and Community Health, Stroke, Annals of Neurology, Archives of Physical Medicine and Rehabilitation, and American Journal of Physical Medicine and Rehabilitation. On average, 17 of the 33 checklist criteria were reported. Criteria describing the study design were better reported than those related to internal validity. No relation was found between study type (etiologic or prognostic) or word count and quality of reporting. A flow diagram for summarizing participant flow through a study was developed. Editors and authors should consider using a checklist and flow diagram when reporting on observational longitudinal research.
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            Methodologic guidelines for systematic reviews of randomized control trials in health care from the Potsdam Consultation on Meta-Analysis.

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              Tips for learners of evidence-based medicine: 4. Assessing heterogeneity of primary studies in systematic reviews and whether to combine their results.

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                Author and article information

                Contributors
                Role: registered physical therapist and PhD student
                Role: clinical pharmacist and assistant professor
                Role: associate professor
                Role: practising intensivist, clinical trialist, and professor
                Role: associate professor, Role: provincial director
                Journal
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1468-5833
                2009
                2009
                12 March 2009
                : 338
                : b866
                Affiliations
                [1 ]Department of Clinical Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Hamilton, ON, Canada L8S 4L8
                [2 ]Department of Critical Care, McMaster Children’s Hospital, Hamilton, ON, Canada
                [3 ]Department of Medicine, McMaster University, Hamilton, ON, Canada
                [4 ]Program in Evidence-based Care, Cancer Care Ontario, McMaster University, Canada
                Author notes
                Correspondence to: M E Kho khome@ 123456mcmaster.ca
                Article
                khom601724
                10.1136/bmj.b866
                2769263
                19282440
                4bd199b6-b1cf-47f3-bf9f-09075e9a154c
                © Kho et al 2009

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 2 December 2008
                Categories
                Research

                Medicine
                Medicine

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