Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Generalizability
- Albert J. Kirshen (17 February 2003)
-
patients' views change
- Elizabeth M Russell (18 February 2003)
-
Study should have been placed in context of previous knowledge and current practice
- Richard Baker, Robin C Fraser (19 February 2003)
-
Did survey respondents make a fully informed choice about consent?
- Ruth G Jepson, Roma Robertson (24 February 2003)
-
Medical Research- NOT an authorised abuse of personal data
- Sachin Maiti (24 February 2003)
|
|
|||
|
Albert J. Kirshen, University of Toronto The Temmy Latner Centre for Palliative Care, Suite 3000, 700 University Ave., Toronto, ON CA M5G 1Z5
Send response to journal:
|
Willison et al have done us great service by beginning to explore patient preferences about the secondary use of data. Regrettably, their small sample size and lack of personal descriptors forces this article into the category of "appetizer" rather than "main course". The authors have not presented data on ethnicity, first language, educational and economic status, information that would have enhanced our ability to generalize to our own population. I look forward to a very much larger study taking into account these and other factors. Competing interests: None declared |
|||
|
|
|||
|
Elizabeth M Russell, emeritus Prof. of Scoial medicine AB15 9NX
Send response to journal:
|
Dear Sir It is very helpful to have a published example of elicited patients’ views, even if it is culture and context specific. The authors report that interviewees formulated and revised their opinions during the interviews. It would be useful to know the direction of change and whether it was consistent. In two small focus group discussions done in Scotland in 2001(1) the participants became less anxious about potential misuse of their medical records when they understood more about how their information is already processed but keener to be asked for consent; this shift has been reinforced by anecdotal information from researchers in consumer participation. 1.Confidentiality and Security Advisory Group for Scotland. Protecting Patient Confidentiality. April 2002. Competing interests: None declared |
|||
|
|
|||
|
Richard Baker, Director, Clinical Governance Research & Development Unit Department of General Practice & Primary Health Care, University of Leicester, LE5 4PW, Robin C Fraser
Send response to journal:
|
Editor - We were dismayed that the BMJ allowed the article by Willison et al's1 to occupy 3.5 pages since it both ignored and added little to what is currently known. In the limited study of the views of only 106 patients, they assert that their study discovered that ‘patients are willing to allow personal information to be used for research purposes, but want to be actively consulted first’ and that ‘Little empirical information exists about patients concerns and preferences for consent for use of (personal) information for research’. Surely it is already well established that it is mandatory to obtain consent for access to personal records for research purposes, unless exceptional circumstances apply. Indeed, in the UK, the GMC places an explicit obligation on doctors to this effect, or to ensure that members of the health care team anonymise the records.2 Furthermore, Doyal3 has previously highlighted the ‘determinants of impracticability for obtaining consent for research’ identified by Willison et al.1 The questionnaire used by Willison et al suggests that their study was concerned with patients’ views on the use of anonymised data, although this is not clear from the article itself. In a study involving 81 general practices and 5069 patients with either asthma or angina, and in which data were anonymised before removal from practices, we wrote to all patients seeking consent to access their primary care records (whether on paper or computer).4 Of the 3429 responders, 9.8% refused consent, even though the research did not concern sensitive issues. Willison et al1 mention neither this evidence, the GMC requirements placed on UK doctors, nor the debate in the BMJ in 1997. We are disappointed that your journal's peer review process did not ensure a more concise article which acknowledged current evidence and practice. Professor Richard Baker
Professor Robin C Fraser
1. Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM, for COMPETE investigators. Patients' consent preferences for research uses of information in electronic medical records: interview and survey data. BMJ 2003;326:373-6. 2. GMC. Confidentiality: Protecting and Providing Information. London: General Medical Council, 2000. 3. Doyal L. Journals should not publish research to which patients have not given fully informed consent - with three exceptions. BMJ 1997;314:1107-1111. 4. Baker R, Shiels C, Stevenson K, Fraser R, Stone M. What proportion of patients refuse consent to data collection from their records for research purposes? Br J Gen Pract 2000;50:655-6. Competing interests: None declared |
|||
|
|
|||
|
Ruth G Jepson, Reseach Fellow Dept General Practice, University of Edinburgh, 20 West Richmond Street, Edinburgh EH8 9DX, Roma Robertson
Send response to journal:
|
Editor, Willison et el report that most patients would prefer the opportunity to provide consent (either written or verbal) before anonymised information from their electronic medical records was used for research.1 They point out there are major logistical challenges to obtaining such informed consent. This is especially true in the primary care setting where ethical concerns prohibit researchers from contacting patients directly.2 Gaining informed consent from each individual in a research study involving thousands of patients may fall to GPs and practice staff, who already have a heavy workload. The additional resource and financial costs would be considerable. In fact, it is unlikely that GPs would agree to do this, and thus primary care research using anonymised electronic data may grind to a halt and one of the advantages of electronic patient records may be lost. Willison's study exemplifies another of the difficulties of obtaining informed choice - that of giving people all the relevant information about a complex issue. As far as we are aware, the participants in the Willison study were not provided with information about the costs of obtaining their consent or the possible consequence of the research being discontinued. Would their responses have been the same if they had been aware of the wider implications? Many patients may not want time and resources to be spent this way, and may also agree with the duty of social responsibility.3 We recognise that patient autonomy is important, and consent is generally the best approach, but perhaps there are times when it is inappropriate.3 Other countries have tried different approaches to this problem. For example, in New Zealand patients are assumed to have given consent if they are registered with practices affiliated with the computer research network of the Royal New Zealand College of General Practitioners.4 These practices put notices in their offices stating that information from a patient's consultation, investigation or referral may be used for research once it is stripped of identifying data. This is only one solution - we need to think about others which respect patient autonomy, yet at the same time do not stifle primary care research. Finding ways of improving public knowledge about the research process using anonymised data is also required. 1. Willison DJ, Keshavjee K, Nair K, Goldsmith C, Holbrook AM. Patients' consent preferences for research uses of information in electronic medical records: interview and survey data. BMJ 2003;326:373. 2. Rogers WA,.Schwartz L. Supporting ethical practice in primary care research: strategies for action. British Journal of General Practice.52(485):1007-11, 2002. 3. Cassell J,.Young A. Why we should not seek individual informed consent for participation in health services research. Journal of Medical Ethics. 2002;28:313-7. 4. Dovey SM,.Tilyard MW. The computer research network of the Royal New Zealand College of General Practitioners: an approach to general practice research in New Zealand. British Journal of General Practice. 1996;46:749- 52. Competing interests: None declared |
|||
|
|
|||
|
Sachin Maiti, Research Registrar Arrowe Park Hospital,Wirral,CH49 5PE
Send response to journal:
|
Retrieval and access of more comprehensive detailed personal medical information are much easier now from electronic records than from hard copies stored in the archives of care-providing institutions. Question arises- who owns the health information? Obviously, healthcare consumers own their medical information 1. Sadan addresses the issues of medical data co-ownership and empower the patient to decide when and to whom to give authorization for its use by a third party and for research.2 The progress of medicine has long been depended on studies of collections of data about individuals protecting their privacy and maintaining the confidentiality. Association of American Medical Colleges states that the ‘’free flow of identifiable medical information within the boundaries of the health care system is essential to the optimum provision of patient care and its payment’’3. Though Willison et al concluded with a very small sample size, a large-scale study with a proper distinction between identifiable and anonymised data collection, will be definitely interesting. 1. Knapp TR, Walter J, Renaudin CP. Property rights and privacy principles. J Healthc Inf Manag 2000 ;14(4):83-93 2. Sadan B. Patient data confidentiality and patient rights Int J Med Inf 2001 ;62(1):41-9 3. Korn D. Medical information privacy and the conduct of biomedical research. Acad Med 2000 ;75(10):963-8 Competing interests: None declared |
|||