Category Archives: Health services

The Cerberus of science – dealing with ethics committees

We asked a colleage, Hannah Rosebrock, to write a blog for us, thank you Hannah.

In Greek mythology, Cerberus guards the gate of the underworld to prevent the dead from leaving. In social and clinical science, this role is fulfilled by ethics committees who stand as guardian between researchers and Cerberusparticipants and prevent the latter to be exploited by the former for the sake of science. The role of the Cerberus is a necessary one – although not very flattering, Cerberus is depicted as a three-headed beast. In the context of ethics committees, its three heads are called bureaucracy, officialdom and inefficiency.

According to the National Health and Medical Research Council (NHMRC) there are more than 200 HRECs operating in organisations and institutions throughout Australia (find a list of human Research Ethics Committees registered with NHMRC here). Although all HRECs base their decisions on the same principles deprived from the same National Statement on Ethical Conduct in Human Research, every HREC has its own application procedures, forms and processes. Further, gaining approval from one ethics committee is no vouch for approval from another ethics committee.

This lack of standardisation specifically affects multi-site projects which led to the founding of the National Mutual Acceptance Scheme (NMA) in 2013. Under the NMA scheme, multi-site research projects do not have to gain ethics approval from every site the project is conducted at but only once, from a NMA certified HREC. As of August 2017 the scope of the NMA scheme covers all human research conducted at a public health organisation in Queensland, New South Wales, the Australian Capital Territory, Victoria, South Australia, and – the latest addition to the scheme – Western Australia. Note: Northern Territory, Tasmania, and private health organisations are not included in the NMA scheme. Still, you might be tempted to think, that the NMA scheme has de-bureaucratised the ethics application process, and to some extent, this is true. There is certainly less duplication (if you don’t count private health organisations, Northern Territory and Tasmania). However, researchers are still fighting with a lack of standardisation, as every state has multiple NMA certified HRECs[1] and application procedures vary between and within states. This multitude in ethics committees, applications processes and forms, seems unnecessarily confusing, given that they are all assessed and certified by the same body (the NHMRC) for their compliance with the same criteria based on the same National Statement of Responsible Conduct in Human Research.

Independent of the HREC approval, researchers have to seek approval from the relevant Research Governance office (RGO) for each site the project is conducted at. There is no such thing as a mutual acceptance scheme for research governance approval, every site has its own assessing criteria for determining the site’s suitability for conducting a given research project. This adds to the generally labour-some and tedious process of gaining ethics approval.  In terms, this uses resources, and most commonly tax payer funded resources. In one Australian study, the cost of obtaining ethics and relevant approvals was $348,000 or 38% of study budget.

Applications for HREC approval are often no less than 63 pages; applications for Research Governance approval encompass about 23 pages – exclusive the extensive supporting documentation required, which can be up to another 150+ pages. Applications to both, HREC and RGO’s vary, with some still requiring submission in hardcopy by snail-mail, (additionally to email, USB and online forms) and will only be assessed, once received in hardcopy. This method is unnecessarily prone to error. To simplify, you must take steps away, rather than adding additional steps. The entire process is so focussed on detail that researchers, as well as assessing HREC and RGO officials can’t see the wood for the trees anymore. So much information is requested that even low-risk research projects that involve none to minimal involvement with participants, and thus hardly justify the use of the term ‘participants’, seem to turn into a second Stanford prison experiment throughout the process.

 

[1] Queensland has 7 NMA certified HRECs, New South Wales has 11, Victoria has 7, South Australia has 5 and Western Australia has 3 (Australian Capital Territory has 1). Find a full list here.

Spending Money to Harm Patients

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Professor Nick Graves is a leading health economist. He has done some fantastic work in the area of infection prevention and control and has an interest in improving health services. I invited Nick to write a blog and he hasn’t disappointed with a blog to stimulate debate and discussion. @Nick_disco_G

Thanks for the blog Nick – Brett

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The notion that scarce health care resources are used to fund technologies and clinical services that harm patients is difficult. Common sense tells us this would never happen. Yet up to 1/3 of all spending in the US is on medical spending for services that do not improve health (1), and evidence that Australia pays for low value or even harmful care is emerging (2, 3).

That fact we do this as part of infection prevention practice is a worry. The community prides itself on improving safety and saving costs, rather than the opposite. The culprit is the continued use of laminar air flow in operating rooms.

In 1969 Charnley and Eftekhar published evidence for reduced numbers of airborne bacterial counts and lower rates of sepsis when laminar air flow was used (4), and in 1978 Lowbury and Lidwell published the findings of a multi-centre randomised trial that showed the incidence rate of joint sepsis was 50% lower in patients that had surgery in an ultraclean environment (5). The Achilles heal of the randomised study was that antibiotic prophylaxis was not included in the analysis, and this might confound the finding about laminar air. Since this study, evidence against laminar air flow has emerged from Germany (6), New Zealand (7), the US (8) and Norway (9). All these data were synthesised in a meta-analysis that provides effectiveness estimates for a wide range of infection prevention bundles for joint replacement (10). It showed that adding laminar airflow to systemic antibiotics and antibiotic-impregnated cement, when compared to conventional ventilation attracted an odds ratio of 1.96 (95% CI 0.52-5.37). So laminar airflow increases risk of infection in joint replacement. And before you worry about statistical significance, remember that a p-value of 0.05 is arbitrary and tells us nothing useful about whether laminar air flow should be part of health services (11, 12).

A decision to continue to use laminar air flow and the impact this has for health services was shown by a recent HTA report completed for the NHS (13).

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An extra 260 patients will suffer a deep infection each year. Treating them will require 127 extra one stage revisions, an extra 150 DAIR procedures (debridement, antibiotics, irrigation, and retention) and 50 extra two stage revisions. This will cost the NHS £5,053,528 in treatment and services and patient health outcomes will of course be worse. A study for Australia (14) showed that continuing with laminar air flow could result in an extra 179 cases, increased costs of $4,592,200AUD and four extra deaths.

There are likely to be many reasons why this practice is not stopped: making a change is risky for altruistic individuals, and I cannot think of anyone who would really want to blow this whistle; the evidence for a making a change can be poked for holes by supporters of laminar airflow; patients are poorly informed and cannot adequately express their preference for safety. This problem is common among health services, and this is one example.

 

References

  1. Fisher ES, McClellan MB, Bertko J, Lieberman SM, Lee JJ, Lewis JL, et al. Fostering accountable health care: moving forward in medicare. Health Aff (Millwood). 2009;28(2):w219-31.
  2. Elshaug AG. Over 150 potentially low-value health care practices: an Australian study. Reply. Med J Aust. 2013;198(11):597-8.
  3. Runciman WB, Hunt TD, Hannaford NA, Hibbert PD, Westbrook JI, Coiera EW, et al. CareTrack: assessing the appropriateness of health care delivery in Australia. Med J Aust. 2012;197(2):100-5.
  4. Charnley J, Eftekhar N. Postoperative infection in total prosthetic replacement arthroplasty of the hip-joint. With special reference to the bacterial content of the air of the operating room. Br J Surg. 1969;56(9):641-9.
  5. Lowbury EJ, Lidwell OM. Multi-hospital trial on the use of ultraclean air systems in orthopaedic operating rooms to reduce infection: preliminary communication. J R Soc Med. 1978;71(11):800-6.
  6. Brandt C, Hott U, Sohr D, Daschner F, Gastmeier P, Ruden H. Operating room ventilation with laminar airflow shows no protective effect on the surgical site infection rate in orthopedic and abdominal surgery. Annals of surgery. 2008;248(5):695-700.
  7. Hooper GJ, Rothwell AG, Frampton C, Wyatt MC. Does the use of laminar flow and space suits reduce early deep infection after total hip and knee replacement?: the ten-year results of the New Zealand Joint Registry. The Journal of bone and joint surgery British volume. 2011;93(1):85-90.
  8. Miner AL, Losina E, Katz JN, Fossel AH, Platt R. Deep infection after total knee replacement: impact of laminar airflow systems and body exhaust suits in the modern operating room. Infect Control Hosp Epidemiol. 2007;28(2):222-6.
  9. Engesaeter LB, Lie SA, Espehaug B, Furnes O, Vollset SE, Havelin LI. Antibiotic prophylaxis in total hip arthroplasty: effects of antibiotic prophylaxis systemically and in bone cement on the revision rate of 22,170 primary hip replacements followed 0-14 years in the Norwegian Arthroplasty Register. Acta orthopaedica Scandinavica. 2003;74(6):644-51.
  10. Zheng H, Barnett AG, Merollini K, Sutton A, Cooper N, Berendt T, et al. Control strategies to prevent total hip replacement-related infections: a systematic review and mixed treatment comparison. BMJ Open. 2014;4(3):e003978.
  11. Claxton K. The irrelevance of inference: a decision-making approach to the stochastic evaluation of health care technologies. J Health Econ. 1999;18(3):341-64.
  12. Goodman SN. Toward evidence-based medical statistics. 1: The P value fallacy. Ann Intern Med. 1999;130(12):995-1004.
  13. Graves N, Wloch C, Wilson J, Barnett A, Sutton A, Cooper N, et al. A cost-effectiveness modelling study of strategies to reduce risk of infection following primary hip replacement based on a systematic review. Health Technol Assess. 2016;20(54):1-144.
  14. Merollini KM, Crawford RW, Whitehouse SL, Graves N. Surgical site infection prevention following total hip arthroplasty in Australia: a cost-effectiveness analysis. Am J Infect Control. 2013;41(9):803-9.