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Commentaries in Response to Controversies in Nephrology |
* Senior Project Officer, CARI Guidelines; Chair, CARI Steering Committee, Centre for Kidney Research, NHMRC Centre for Clinical Research Excellence, The Children’s Hospital at Westmead, Westmead, Australia; Medical Director, Kidney Health Australia, Adelaide, South Australia, Australia; and Executive Member, CARI Steering Committee, and Coordinating Editor, Cochrane Renal Group, Centre for Kidney Research, NHMRC Centre for Clinical Research Excellence, The Children’s Hospital at Westmead, Westmead, Australia
Address correspondence to:Address correspondence to: Dr. Jonathan Craig, CARI Guidelines, Centre for Kidney Research, Locked Bag 4001, Westmead, New South Wales, Australia 2145. Phone: 612-9351-4823; Fax: 612-9351-5049; E-mail: jonc{at}pub.health.usyd.edu.au
On behalf of CARI (Caring for Australasians with Renal Impairment; www.cari.org.au), the national kidney guidelines group of Australia-New Zealand, we would like to respond to the recent series of articles in CJASN on the role of industry in renal guideline development.
CARI is funded through unrestricted educational grants from the pharmaceutical industry and the Australian government through a National Health and Medical Research Council Centre of Clinical Research Excellence grant. Unlike the Kidney Disease Outcomes Quality Initiative, individual guidelines are not funded; rather all funding provides core infrastructure to support all guideline activities. The annual budget of AU$300,000 has been adequate to fund development of two new major guidelines each year, update old guidelines (published for more than three years), and commence active guideline implementation projects.
The evidence threshold we use for guideline statements is high. Unless there are data obtained from a systematic review of all relevant randomized clinical trials (RCT) (Level I), or at least one properly designed RCT (Level II), the guideline writers are unable to formulate a specific recommendation. Instead, the statement "No recommendations possible based on Level I or II evidence" appears in the guideline box. Recognizing the tension between scientific validity of statements based upon robust evidence and clinical usefulness of guidelines, we have a separate "Suggestions for Clinical Care" category of statements.
Here, management suggestions based on Level III and IV evidence (case series, cohort studies, etc.) are inserted.
We require all new guideline group members and convenors to sign a conflict of interest (COI) declaration before they commence work on a CARI guideline. We also ask members of the CARI Steering Committee, which oversees all guideline activity, to sign and forward the COI declaration. The COI document specifies two levels of conflict. Level I conflict, which includes a pecuniary interest in a relevant pharmaceutical company, precludes participation in the CARI process. Level II conflict does not preclude participation but the conflict has to be identified to the convenor and members of the guideline group and to the CARI Steering Committee. Details of the COI levels are on the CARI website. Furthermore, CARI requires individuals to declare all relevant financial affiliations, such as memberships of advisory boards, that have existed in the past three calendar years.
All details of CARI income sources are included in the Annual Report, which is circulated to the 12 Steering Committee members, and an abridged version is placed on the website. We acknowledge all sponsorships in our print publications and on our website. In the future, extracts of COI statements made by all guideline writers will be published with their guidelines.
Guideline topics are not chosen because they are fundable but because they are clinically relevant, as decided by the leadership of the Australia–New Zealand Society of Nephrology. The current new set of guidelines on renal vasculitis is unlikely to have little commercial value to any company. In addition, CARI does not have a separate evidence review team.
The writers are the evidence review team and so know the design and results of the relevant studies directly, which we believe leads to better linkages between the evidence and the guidelines.
Waiting for government to fund guidelines is ideal but unrealistic. Finding capable and willing guideline writers with no COI is also ideal but unrealistic. We believe that it is possible to have guidelines in which bias is minimized if industry funding is not linked to choice of topic, if a high-level COI policy that makes some guideline writers ineligible is in place, if a very structured approach to evidence synthesis is used, if a rigorous peer-review process occurs, and if the local nephrology community is increasingly evidence-aware and "expert"-skeptical.
The Australia-New Zealand renal community values the CARI guidelines that have been produced to date and trusts their credibility. A recent survey (unpublished observations) of all nephrologists in Australia and New Zealand (70% response rate) found that a majority of nephrologists support, use, and trust the CARI guidelines and feel that the guidelines have improved patient outcomes.
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