This short chapter describes how we went about writing the 3rd Edition of the Standards Document. It was written by Paul Roderick and myself.

We would welcome comments on any aspect of the chapter. I would be most grateful for comments on any aspects of the chapter to be e-mailed to me at mmd175@abdn.ac.uk. We look forward to hearing your comments.
Thank you for your interest.

Alison MacLeod
Chairman, Standards & Audit Subcommittee of the Renal Association.

The Second edition of this document was reviewed by the Health Care Evaluation Unit of the Department of Public Health Sciences at St George's Hospital Medical School using their "Appraisal Instrument for Clinical Guidelines". Their suggestions were as far as possible incorporated into this document and the following process of development of this edition described using their schema⁽¹⁾.

2.1 Responsibility for guideline development. In November 1997 the Renal Association in conjunction with the Royal College of Physicians of London convened the Standards and Audit Subcommittee to produce the third edition of the "Treatment of Adult Patients with Renal Failure - Recommended standards and audit measures". The Renal Association provided funding for travel to meetings and for an small exploratory literature search. Members of the committee wrote the chapters in their own time. We decided to include the care of children fully in this document rather than as an appendix and hence the change in title. The chapter on Transplantation was written jointly by this committee and the British Transplantation Society. The chapter on acute renal failure in conjunction with the Intensive Care Society, a member of which was on our committee. All paediatric addenda were written along with members of the British Association of Paediatric Nephrology (BAPN) a member of which was also on our committee.

2.2 Guideline development group. The membership of the Committee was expanded for this edition of the document (for a full membership list see page x). There was representation from the Federation of Kidney Patients Associations, nursing staff, medical staff caring for adults and children with renal disease, public health medicine, the UK Renal Registry, NHS management, the Royal College of Physicians of London and the Renal Association. Members of the Departments of Health of England, Wales, Northern Ireland and Scotland were present as observers.

2.3 Identification and interpretation of the evidence. The recommendations in the Standards Document vary in their underlying nature and hence in the types of evidence required. They are of 6 main types:

(a) The optimal interventions to use (eg which membrane for haemodialysis)
(b) Target values of intermediate patient outcomes (eg haemoglobin, phosphate, bicarbonate)
(c) Epidemiological data (eg about population need).
(d) Statistical methodology (eg outcomes data).
(e) Organisation of services (eg how many transplant units for a given population base).
(f) Good clinical practice, particularly with regard to ethical issues (eg the decision to withhold or withdraw dialysis should be made after consultation with the patient and his/her family).

(a) For most interventions the best type of evidence is the randomised controlled trial. If several trials have addressed one question they can be subject to metanalysis or to systematic review that may or may not incorporate a metanalysis. These are available on the Cochrane database of reviews (www.cochrane.co.uk) or the York CRD DARE* database (www.york.ac.uk/inst/crd/clibsec2.doc). Compared with many areas of medicine particularly cardiology, stroke medicine and oncology there are relatively few trials with both patient centred outcomes (including survival, quality of life and hospitalisation rates) and sufficiently long follow up. The paucity of such trials may in part reflect the smaller number of patients with ESRD but there is a need routinely to trial new drugs and technologies for such patients as is done for those, for example, with haematological malignancy. This may be particularly difficult, however, for interventions in the small number of children with ESRD.

The above databases were searched for relevant topics for all chapters and subsequent papers retrieved and forwarded to the writers of the chapters for appraisal and inclusion where appropriate. We aimed also to review the evidence from relevant trials using databases such as Medline or Embase but we had insufficient resource; a formal search for publications on the treatment of hypertension was made. Our evidence based approach was supported by the National Institute of Clinical Excellence (NICE) although they had no funding available at that time. A grant application was therefore submitted to the National Kidney Research Fund to review the evidence base for questions selected by the Standards and Audit Subcommittee. This grant was awarded in December 2000 and the systematic reviews produced will provide an improved evidence base for future editions of this document.

The chapter authors therefore searched the literature often using Medline in the manner of the previous edition. Trials and retrospective and prospective cohort studies were the principle sources and the evidence was graded using the system of the US Department of Health and Human Services (1992) (Table 1)⁽²⁾.
* Centre for Reviews & Dissemination - Database of Abstracts of Reviews of Effectiveness

(b) Several of the standards are values of intermediate patient outcomes (eg haemoglobin, phosphate). Randomised trials can be carried out for such values particularly where one or two major interventions can markedly influence the value eg the influence of epoetin and iron therapies on haemoglobin values. Patients can be randomised to two target haemoglobin ranges and outcomes compared. In contrast potassium values must be kept within a narrow range to maintain life and hence a trial would be entirely inappropriate.

Other indices eg phosphate and bicarbonate values may be useful indicators of the quality of the overall process of dialysis care reflecting the effect of diet, drug therapy and/or length and nature of dialysis treatment. Trials of target ranges would be theoretically possible but such intermediate outcomes as phosphate are unlikely to be used as primary interventions. Achieved values may vary between countries and in part reflect the resources invested in dialysis therapy and hence cohort studies require cautious interpretation.

Trials were evaluated, where available, by chapter authors along with cohort studies. Evidence levels quoted in Table 1 are used where appropriate. Other recommendations are termed "good clinical practice - GP".

(c/d) Important standards concern the population needs for treatment and the ways in which data on patients with renal failure should be monitored and statistically analysed eg "data on patients with end stage renal disease should be recorded by the UK Renal Registry". Such standards have been defined as "good epidemiological practice".

(e) Several standards concern the organisation and delivery of services for patients with renal failure. Optimally the evidence based clinical standards should serve as building blocks for standards of service provision. For example a clinical standard indicating a target value for haemoglobin could translate into a service provision standard of adequate epoetin and iron provision and appropriate staffing to deliver that standard. The evidence base for many aspects of care of patients with renal failure still requires to be determined and hence the standards of service provision quoted are frequently based on consensus. For other service a standards consensus view is the appropriate and only sensible way to establish them and this was obtained, following discussion, at the meetings of the multidisciplinary Standards and Audit Subcommittee.

(f) Some standards concern ethical issues and recommendations are termed "good clinical practice" as described in section (b) above.

2.4 Formulation of recommendations. The document was divided into chapters and one or more frequently two members of the group who had a particular experience or interest in the area were selected. Collaborations with other societies are discussed in section 2.1. A presentation was initially made at early meetings of the group. With comments made at the presentation , available literature as described above and the second edition of the Standards Document a draft chapter was produced and circulated. The authors guided the rest of the committee through the chapter at subsequent meeting where the evidence was evaluated. Following extensive discussion at these multidisciplinary meetings a second draft was produced and any subsequent changes discussed at the next meeting. Where opinions differed, often because the evidence base was lacking, the group worked together to produce a form of words acceptable to the majority.

2.5 Peer Review. The various chapters were then placed on internet sites used by patients and healthcare workers including, nurses, doctors (both adult and paediatric physicians), dialysis technicians, and dieticians. All members of the Renal Association and BAPN and all UK renal units received notification of the websites and contact was made with the Irish Society of Nephrology. In addition a printed copy was sent to every renal unit in the UK for distribution to all interested staff members. One month was allowed for comment and these were forwarded to the chapter writers and to other members of the committee if appropriate.

Table 1

* Strength of recommendation:

1. Cluzeau F, Littlejohns P, Grimshaw J, Feder G. Appraisal instrument for clinical
guideslines (Version 1). St George's Hospital Medical School, London 1997

2. US Department of Health & Human Services. Public Health Service and Agency for
Health Care Policy & Research. Acute Pain Management: operative or medical procedures and trauma. Rockville, Maryland. Agency for Health Care Policy & Research (AHCPR publication 92-0038) 1992.

We would very much like your comments on this document

Please send them to Alison MacLeod, Chairman, Standards & Audit Subcommittee of the Renal Association, at: mmd175@abdn.ac.uk