Letter to the editor from Dr Cathal Ó Súilliobháin, Blackrock, Co Dublin
The standard definition of clinical practice guidelines (CPGs) is that of “systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific circumstances” (US Institute of Medicine).
The words “systematically developed” are key in this definition and HIQA’s recently published document, Draft National Quality Assurance Criteria for Clinical Guidelines highlights the dangers of poorly devised guidelines. It states:
• Poor quality or out-of-date guidelines can encourage the delivery of ineffective, wasteful interventions that may do more harm than good.
• The evidence base that allows development of recommendations may be incomplete, misleading or misinterpreted.
• Guidelines can be viewed as being restrictive for healthcare professionals making it difficult to tailor care to service users’ specific condition and circumstances.
• Recommendations may be in–fluenced by the opinions, clinical experience and composition of the guideline development group.
• Recommendations for costly interventions may displace limited resources that are needed for other services of greater value to service users.
• The value judgement made by a guideline development group may be inappropriate for individual service users.
• There may be concerns that guidelines could be used as citable evidence for malpractice litigation against healthcare professionals, although there has not been significant use of guidelines for this purpose.
These caveats have a particular relevance to a set of clinical guidelines that were published in 2008 by the ICGP “Managing Opiate Users in Primary Care”. Serious concerns have been raised by a number of GPs, including myself, about the content of these guidelines and the process that led to their publication. The guidelines are the cornerstone of the compulsory audit of GPs treating opiate users. The audit is part of their contract with the HSE.
I believe the audit process is inherently flawed, relying heavily on indicators that are not evidence based e.g. urine testing. It does not properly measure outcomes for patients or the performance of the GP.
It was agreed at a meeting of GPs working in addiction that advice from the Medical Protection Society (MPS) be sought. The opinion of the MPS was that doctors should not follow clinical guidelines they believed to be flawed and to raise our concerns directly with the ICGP.
In July 2010, the HSE commissioned a review of the Methadone Treatment Protocol. Professor Michael Farrell, Professor of Addiction Psychiatry at King’s College London, carried out this review. Professor Farrell’s report recommends a significant reduction in urine testing. During oral submission to the review by GPSSA and the IMO we raised our concerns about the ICGP guidelines and audit. Prof Farrell’s advice, like the MPS, was to alert the ICGP of our concerns.
In October 2010, we wrote to the ICGP Director of Quality and Standards detailing our concerns around the guidelines and the process leading to their publication.
The 2008 version was a reviewed edition of guidelines first published in 2003. There were two changes in the 2008 version, which were of critical importance.
1. A decrease in the average methadone dosage range from 60-120mg (2003 version) to 60-80mg (2008 version).
2. A removal from the 2008 version of a caution regarding maximum dose increase in the first week of treatment.
The first change could lead to inadequate dosing and treatment failure. Increasing methadone dosage too quickly in the first week of treatment can and has led to fatalities.
Neither of these changes nor many others appeared in partial drafts circulated to “contributors”. The ICGP Director of Quality and Standards responded, having consulted the ICGP Director of the Substance Misuse Programme. The director conceded on many our points but gave no explanation for the inclusion or deletion of erroneous content. Neither did she explain or dispute the absence of adequate consultation with other contributors to the guidelines.
She did confirm that she could not locate a final draft, which should have been circulated prior to publication. Following this correspondence she agreed to meet us with the Chairperson of the ICGP Audit Review Group to discuss the matter further. We reiterated our concerns for patient safety and asked her for the following:
• An independent review of the process that led to the publication of the guidelines.
• An independent expert from abroad be consulted to assess their clinical content.
• The 2008 version be withdrawn until the review is completed and the 2003 guidelines be used as an alternative.
• My name be removed from the 2008 guidelines immediately and GPs who received the publication be notified.
After a delay of two months ICGP Director of Quality and Standards wrote to us to say that she had referred the matter to the Audit Review Group. We have heard nothing from her since.
Six months ago, the Chair of that committee wrote to say that the Audit Review Group was meeting and would be making a decision soon.
We have heard nothing from him since. We subsequently wrote to the CEO of the ICGP. In summary:
• He accepted that the review process was flawed but stated that the ICGP was satisfied that adequate consultation took place!
• He stated that he was sending our original letter back to the “Best Practice Committee” for their opinion. (This is puzzling as to my knowledge, there is no Best Practice Committee).
• He alluded to a “National Guide-line” which he claims will be built upon the work of the ICGP guidelines. This is particularly worrying in light of our concerns. He goes further and states that the current ICGP guidelines (notwithstanding our concerns around patient safety, including potential fatalities) will be left in place.
We first wrote to the CEO in April requesting a meeting with him. We have still to meet him. A HSE group, which includes representatives of the ICGP, has started to review these guidelines again recently.
We wrote to the HSE requesting the terms of reference of the group and its membership but have been refused this information or representation on the review group.
Recently, 36 GPs working in addiction, many of them Level 2 certified, signed a letter stating that they did not wish to be represented by the ICGP in any such group.
Since February this year when it became clear to me that my concerns, and those of a number of very experienced GPs, were not being acted upon by the College, I have requested the ICGP through the Director of Quality and Standards and the CEO to remove my name from the present version.
Although my name has been quietly removed from the College website version (I don’t know when, I was not informed), it is in the printed version which most GPs treating opiate users received and to my knowledge there has been no notification of the removal of my name or the reason, to those who received it.
I see no alternative other than attempting myself to inform GPs of my concerns and the fact that I am disassociating myself from these guidelines.
