The need for systematic reviews of reasons

Bioethics

Volumn 26, Issue 6, 2012, Pages 315-328

  Sofaer, Neema ^a   Strech, Daniel ^b  

^a KING'S COLLEGE LONDON   (United Kingdom)

^b HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

Bioethics; Delivery of health care; Ethics; Human experimentation; Policy making; Review literature as topic; Systematic review

Indexed keywords

ARTICLE; DECISION MAKING; ETHICS; HEALTH CARE DELIVERY; HUMAN; HUMAN EXPERIMENT; LITERATURE; MANAGEMENT; THEORETICAL MODEL;

DECISION MAKING; DELIVERY OF HEALTH CARE; ETHICAL ANALYSIS; HUMAN EXPERIMENTATION; HUMANS; MODELS, THEORETICAL; POLICY MAKING; REVIEW LITERATURE AS TOPIC;

EID: 79960488047     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2011.01858.x     Document Type: Article

References (101)

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18. McCullough et al., op. cit. note 1.
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20. Other possible outcomes presumably include the ethical permissibility or impermissibility of the intervention, and whether or not the intervention should be required by guidelines.
21. McCullough et al., op. cit. note 1, p. 69.
22. McCullough et al., op. cit. note 1, p. 67. We find the measure of adequacy confusing, because the summary score and score for the third feature measure the same thing: the quality of the ethical analysis and argument.
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24. The paper expresses non-standard concepts of validity and soundness. A standard definition of validity holds that an argument is valid if and only if it is necessary that, if all the premises are true, then the conclusion is true (A.P. Martinich. 2005. Philosophical Writing. An Introduction. Malden: Blackwell Publishing: 20). Validity does not imply that the premises are true and does not imply non-circularity. However, for McCullough, a valid argument must be more than logically valid: it must also be the case that 'relevant clinical and other facts [are] clearly identified and supported' and that the argument comprises 'a coherent whole' (p. 1100)
25. Similarly, '[a] sound argument is an argument which is valid and which contains only true premises' (Martinich, op. cit. note 16, p. 20). But, for McCullough, a sound argument is, among other things, one with a conclusion on which the physician can act with confidence that patient care will be improved as a result. Such an argument must be more than sound: for example, it must also be relevant to the clinical decision.
26. The operational definition of informal review is given in our systematic review: N. Sofaer & D. Strech. Reasons why Post-trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review. Unpublished Manuscript.
27. Decision-makers who may benefit from such systematic reviews include regulators, Institutional Review Boards (Research Ethics Committees) and designers of research protocols, for example researchers, sponsors of research, and Contract Research Organizations.
28. McCullough et al., op. cit. note 1, p. 73.
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31. Sofaer & Strech, op. cit. note 17.
32. N. Sofaer & D. Strech, op. cit. note 17.
33. To be precise, in our systematic review, we recorded whether reason occurrences were used to argue that post-trial access should, or need not be provided.
34. D. Strech & N. Sofaer. How to Write a Systematic Review of Reasons. Unpublished manuscript; Sofaer & Strech, op. cit. note 17.
35. Strech & Sofaer, op. cit. note 24.
36. There is need for research to determine how best to distil and to construct a suitable measure of quality.
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38. These wide disparities were only slightly reduced when types of reason were broadened to ensure that the disparity was not an artifact of having very narrowly individuated reasons. The informal reviews included in our systematic review were: R. Ashcroft. 2005. After the Trial is over: What are the Sponsor's Obligations? Available at: [Accessed 6 July 2010]
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52. We lack evidence that neglect of relevant reasons leads to poor decision-making. However, this seems to us to be a probable assumption, particularly when - as revealed by our systematic review of reasons -many and entire classes of published reasons are ignored. The content of the decision, which might be the selection of a policy, plausibly depends on the reasons considered. The fact that official bodies place such emphasis on collecting the relevant literature and giving voice to different groups of stakeholders suggest that they share this assumption. Furthermore, even if ignoring a relevant reason makes no difference to the content of the decision, it does make a difference to its perceived legitimacy. Particularly when the reason is associated with particular stakeholder groups, its omission will lay decision-makers open to the criticism that they ignored those stakeholders' perspective.
53. Of course, this is only true to the extent that such reasons are found by the systematic review. It is true that a systematic review increases the pool of findable reasons. However, since a systematic review relies on specific sources of data, such as particular databases, these in turn become the gate-keepers and must be scrutinized for comprehensiveness.
54. Admittedly, the risk arises that readers presented with what purports to be a comprehensive review will be less likely to wonder what it omits. The review's limitations must be clearly identified so that readers remain alive to the possibility that there may be relevant reasons which have never been published.
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56. It was also necessary to conduct an extensive consultation because the systematic review did not adequately capture the views, for example, of industry and patients, and because of the need for legitimacy. Further limitations are given in the text.
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58. Systematic reviews of reasons should be updated frequently, as is recommended in the case of classical systematic reviews. J.P.T. Higgins, S. Green & R.J.P.M. Scholten. 2008. Chapter 3: Maintaining Reviews: Updates, Amendments and Feedback. In Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 (updated September 2008). J.P.T. Higgins & S. Green (eds). The Cochrane Collaboration. Available at: [Accessed 3 Feb 2010].
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75. Even if a McCullough Model systematic review discloses that the literature's all-things-considered ethical conclusion may not be the truth, and the disclosure prevents readers from thinking that the conclusion is the truth, a systematic review of reasons is still preferable, in that only it presents the detailed data on reasons that decision-makers, scientists and academics need.
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88. B. Greenwood & W.P. Hausdorff. 2003. After a Trial is Over: The Ethical Issues. Available at: [Accessed 6 July 2010]
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95. Z. Zong. Should Post-trial Provision of Beneficial Experimental Interventions be Mandatory in Developing Countries? J Med Ethics 2008; 34: 188-192.
96. Such multidisciplinary research should include the identification of an appropriate, measurable concept of cost as well as empirical research.
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100. We thank Leif Wenar for this point.
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