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figures/calculations and conclusions still valid). Meanwhile, we would advise database researchers handling datasets in excess of 65 535 rows of patient records to use later versions of Microsoft Excel, and to confirm their denominator data through secondary, independent analysis. S. M. White Royal Sussex County Hospital Brighton, UK Email:
[email protected] I. K. Moppett University of Nottingham, Queen’s Medical Centre Campus Nottingham University Hospitals NHS Trust Nottingham, UK R. Griffiths Peterborough and Stamford Hospitals NHS Trust Peterborough, UK Competing interests as given in reference [2]. We are grateful to Mr Tim Bunning, Principal Consultant, Crown Informatics Limited, for alerting us to the possible error in the numbers. Previously posted on the Anaesthesia correspondence website: www.anaesthesiacorrespondence.com
References
1. Sessler DI. Big Data – and its contributions to peri-operative medicine. Anaesthesia 2014; 69: 100–5. 2. White SM, Moppett IK, Griffiths R. Outcome by mode of anaesthesia for hip fracture surgery. An observational audit of 65 535 patients in a national dataset. Anaesthesia 2014; 69: 224–30. 3. Microsoft Excel specifications and limits. http://office.microsoft.com/en-gb/exc el-help/excel-specifications-and-limitsHP005199291.aspx (accessed 06/02/ 2014). 4. Correction. Anaesthesia 2014; 69. doi:10.1111/anae.12652
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Big Data – ethical perspectives Large, linked databases (‘Big Data’ [1]) use pseudonymised personal confidential data that have been anonymised but retain a residual risk of re-identification. Sessler outlines the potential benefits of these databases in his editorial [1], with regard to rapid improvements in the quality and affordability of healthcare. However, there are ethical aspects that must be considered when balancing potential benefits against potential harms. Non-maleficence describes ‘an obligation not to inflict harm on others’ [2]. The potential for harm in epidemiological database research is not as immediately apparent as for clinical trials, but individuals can still be wronged when they have not suffered direct harm per se. There are two main ethical areas of concern: firstly, that vulnerable groups may become stigmatised; and secondly that people are ‘treated’ as a means to an end, rather than as an end in themselves. Although the aim of collecting data about vulnerable groups is to improve care, information could be used to discriminate against them, or stigmatise them. Retained identifiers such as postcodes can provide information about disease burden linked to geographical socio-economic deprivation. In rare conditions, the possibility of re-identification becomes very real. Boyd [3] uses the example of an ethnic minority with an inheritable condition deemed potentially harmful to the majority population, who are coerced into
birth control. Public concerns often centre around inadvertent disclosure of information to third parties, including employers, insurance companies [4], drug companies or criminal organisations. Personal autonomy is recognised and protected through the process of providing consent, such that “patients must be fully informed of, and agree without coercion to, any participation in medical research” [5]. The Data Protection Act 1998 states that consent is not needed for anonymised data, and it has been argued that seeking formal consent for data inclusion within health databases could cause harm. The Academy of Medical Sciences has suggested that any insistence on formal consent could cause such significant selection, recruitment and participation bias that it would skew the data to such an extent as to make it not worth collecting [6]. It would also use precious resources such as time and money, and prohibit large studies. In addition to this, a traditional informed consent process, where a researcher asks for permission to do something to a participant at a single point in time, is likely to be unfit for purpose – the initial researcher is unlikely to know the nature of research to be carried out in the future, and future research would require re-consent, and therefore the necessity for patient contact identifiers to be held simultaneously on any database. Non-consensual use even of pseudonymised data risks damaging trust between patients, healthcare professionals and government bodies. NHS England has proposed
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an ‘opt out’ option, whereby all patients using NHS services are provided with information about how their data will be used for health services research and their consent assumed unless they specify their refusal [7]. However, public awareness and engagement are essential, and the recent decision by NHS England to delay introduction of their ‘care.data’ program indicates that there is considerable work still to be done in this area [8]. The aims of ‘Big Data’ are impressive, and the potential benefit is significant. Reversible anonymisation in a secure environment, supported by sanctions and regulations, helps to protect individual privacy. Coupled with ongoing engagement with the public and ultimately positive public approval and trust, this maintains individual autonomy. By training researchers and governors to high ethical standards, and fostering the virtuous character traits, maleficent breaches of confidentiality should be minimised. Finally, by emphasising the principles of solidarity, altruism and unselfishness, with an acceptance that there will be some trade-offs in the pursuit of these goals, we should seek to use the opportunities that ‘Big Data’ offers to research and clinical practice.
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References
1. Sessler DI. Big Data – and its contributions to peri-operative medicine. Anaesthesia 2014; 69: 100–5. 2. Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 6th edn. New York: Oxford University Press, 2008. 3. Boyd KM. Ethnicity and the ethics of data linkage. BMC Public Health 2007; 7: 318. 4. Scottish Government. Public acceptability of Data Sharing Between the Public, Private and Third Sectors for Research Purposes, 2013. http://www.scotland. gov.uk/Publications/2013/10/1304/8 (accessed 20/02/2014). 5. 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. 6. Academy of Medical Sciences. Personal data for public good: using health information in medical research, 2002. http://issuu.com/acmedsci/docs/personal (accessed 20/02/2014). 7. NHS England. Better information means better care. www.england.nhs.uk/ourwork/tsd/care-data/ (accessed 20/02/ 2014). 8. Triggle N. Care.data: How did it go so wrong? 19 Feb 2014. www.bbc.co.uk/ news/health-26259101 (accessed 20/ 02/2014). doi:10.1111/anae.12656
Co-amoxiclav discolouration Further to the experience of Kearsley et al. [1], whilst reconstituting
1.2 g amoxicillin sodium/clavulanic acid (co-amoxiclav, Wockhardt UK Ltd, Wrexham, UK) in water (Fannin, Leopardstown, Dublin), I noted an unusually dark colour of the resultant solution (Fig. 1). Close inspection of the co-amoxiclav vial revealed a crack in the glass around the neck. The solution was discarded and not administered. Co-amoxiclav changes colour slowly after reconstitution, due to changes in the pH of the solution [2]. Presumably, oxidation of the vial contents altered their pH, resulting in early discolouration. After reconstitution in 20 ml water, the manufacturer recommends intravenous injection within 20 minutes [3]. This incident serves to remind anaesthetists to check for defective drugs packaging, which could result in chemical/physical degradation and subsequently ineffective drug action, or in potential microbial contamination of that drug. J. S. Dawson Nottingham University Hospitals NHS Trust Nottingham, UK Email:
[email protected]
A. Docherty Royal Infirmary of Edinburgh Edinburgh, UK Email:
[email protected] No external funding and no competing interests declared. Previously posted on the Anaesthesia correspondence website: www.anaesthesia correspondence.com.
Figure 1 Discoloured co-amoxiclav (top) drawn up from cracked vial, compared with normal co-amoxiclav (bottom).
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