Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Obstructing evaluation harms patients
- Steve Goodacre (2 August 2004)
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Re: Obstructing evaluation harms patients
- Tony Soteriou (4 August 2004)
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Negative effect of ethics on NHS funded voluntary sector based projects
- Ann Kenyon (7 August 2004)
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Steve Goodacre, Senior Lecturer University of Sheffield
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Soteriou states that “Research not meeting these ethical and quality standards can represent a potential risk to patients, researchers, and wider NHS research…” and cites the Royal Liverpool Children’s Inquiry, the Bristol Royal Infirmary Inquiry, and the Isaacs Report to support this assertion. He may as well also have cited Shipman, the Hutton Inquiry and the sinking of the Titanic for all the relevance these reports have to the kind of project this article relates to. At worst, Jones and Bamford made an honest mistake that resulted in the participants in their project being slightly misled as to the kind of follow-up they would receive. How does this relate to harvesting organs without consent? Unfortunately, the use of scandals, such as Alder Hey, to justify every kind of bureaucratic over-reaction is widespread. I recently encountered a member of an ethics committee who insisted that our intention to use anonymised data without explicit consent was similar to removing organs without consent. I wondered if he would like to explain this “ethical” standpoint to the families of children who had their organs harvested? The reference to Bristol is even more absurd. Surely the lessons of Bristol are that rigorous evaluation of patient outcomes is essential to ensuring a quality service? The Report stated that “Information about performance in the NHS is the basic building block of any system of standards and quality”. How can this possibly be achieved when we are driving a wedge between research and audit? We seem to have developed systems for research ethics and governance that are appropriate for high-risk or highly sensitive areas of research, such as human volunteer studies and clinical trials, but are now applying them unthinkingly to all other areas. Health service research doesn’t work like that. If we suspend a project for two months we may miss our chance to evaluate a new service. The change will have happened, the new service will be in place and we will have no idea whether it worked or not. Patients will have been badly served and will continue to be badly served, but who will be held accountable? Competing interests: None declared |
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Tony Soteriou, Director of Research Avon and Wiltshire Mental Health Partnership NHS Trust, Bristol BS16 1QY
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It is hoped everyone would agree with Goodacre's argument that evaluations of services and treatment are fundamental to quality care. However, Goodacre appears to rather have missed the point. The cases of Royal Liverpool Children’s Inquiry, the Bristol Royal Infirmary Inquiry, and the Isaacs Report cite issues surrounding lack of consent, and may have contributed to damaged public perception of research in the NHS, and to patients' and public trust. In the Bristol Royal Infirmary Inquiry, the report quotes one parent stating: "You cannot trust people if you do not think they are being honest, even if they are being nice. Once you think that they might not say the thing as it is, then you can never believe quite - there is no working relationship from that point on.". It is therefore surprising and worrying that Goodacre appears to say that by having only "slightly misled" patients, there is no problem. Would Goodacre like to explain this ethical standpoint to the patients in question, who were people with eating disorders and in many cases with co- existing mental support needs. Furthermore, Goodacre appears to ignore that in the case highlighted by Jones and Bamford, the Trust itself provided funding to conduct a small pilot quantitative study to explore whether quantitative measures could be used to predict outcomes. The pilot was not statistically powered to produce an answer, but merely to explore the choice of quantitative measures. The researchers deciding to add a qualitative aspect to this work, substantially changed the nature of the work funded. The project was not an evaluation or an audit, but a pilot research project. There is a difference, methodologically and ethically. Finally, Goodacre does not balance his argument with the fact that Trust assisted the researchers to redesign the research to their preferences, although the researchers were not familiar with the demands of qualitative research, and provided further funding to continue the project. Competing interests: TS Chairs the NHS R&D Forum Research Governance Working Group |
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Ann Kenyon, Project Coordinator Warrington CAB GP Outreach Service, 46 Benson Road, Birchwood, Warrington WA3 7PQ
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We gained funding in August 2003 from our local primary care trust to provide a Citizen’s Advice Bureau Outreach Service in GP surgeries, tackling the wider determinants of health i.e. by resolving debt problems, employment and relationship issues. We hope our 18 months’ funding will be extended, however this largely depends on preliminary results of an independent evaluation due in October 2004. This evaluation has had to go through ethical approval which took until May 2004, by which time we had seen 291 clients. Evaluation of this sample would have given a good indication of the type and depth of work we do, however due to the delay with ethics, preliminary findings can only be based on cases opened and closed within a three month period. This sample is already vastly reduced due to the summer holidays when both referrers and patients are away. More importantly, as it takes a lot longer than three months to resolve complex debt cases or tribunals, few, if any, of these cases will appear in the preliminary outcomes. Resolving complex social problems brings the greatest improvement in health and wellbeing for our clients and we as a team are frustrated by the fact decisions on our future funding could be made using outcomes which do not truely represent our work. We are well aware our service is working well from our internal evaluation, increasing referrals from GPs and other health professionals, financial gains, clients telling us they are less stressed and practice staff saying they value the service. As for the risks to taking part in research; these should always be considered in all studies but as Goodacre argued, ethics for service evaluation using questionnaire based data collection are not the same as those for drug trials, surgical outcomes and pathological investigation of body parts. In our study, despite the fact all cases could be included, we always put our clients first. For example, if a client has lost a loved one during the course of our help, it would be extremely insensitive to send them a questionnaire asking if their health has improved. We use our discretion and common sense. Clinical governance is in place to protect patients yet takes no account for the data collector’s relationship with their clients/patients. It also lacks any mechanism to differentiate or expedite studies measuring health improvement and quality of life from those involving invasive medical interventions. This needs to be addressed to prevent considerable time, money and effort being wasted in all sectors and to secure the continuation of quality health-related research. Competing interests: None declared |
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