The Following List Contains Items That Can Be Subjected To Audit Before And After Renal Transplantation.

A3.3 (Para 7.42)  
Pre-transplant

Number of organ donors each year/million population

Number of renal transplants performed per million population per annum, both cadaver and living, related and unrelated

Proportion of patients on dialysis entered on to the transplantation waiting list

Waiting time of patients on dialysis

Equity of access to: (a) the transplant waiting list; (b) transplanted kidneys (Particular attention should be paid to patients from ethnic minorities and older patients, and the age range on the transplant waiting list should be reviewed)

Number of patients on the transplant waiting list and their degree of sensitisation against common HLA antigens (see Appendix 4)

Proportion of patients receiving a 'favourable match' kidney

Number of kidneys that are unsuitable for use because of their anatomy or damage during retrieval

Early (first year) post-transplant

Cold storage times of transplanted kidneys

Proportion of cadaver transplant recipients with immediate function, delayed function and failure in function

Number of days hospitalisation in the first subsequent years after transplantation

Proportion of patients with urological problems after grafting

Proportion of patients with renal vascular problems after grafting

Incidence of wound infections after transplantation

Number of other serious infections (abscesses, septicaemia, serious fungal or viral disease) in the post-operative period and later

Proportion of patients with one or more histologically diagnosed rejection episodes in the first 3 months

Percentage of these episodes that were resistant to corticosteroid treatment
Incidence of graft loss from acute rejection in the first 3 months
Plasma creatinine concentration in those with functioning grafts
Incidence of death with a functioning graft in the first 3 months

   
Long term post-transplant

Frequency and causes of death

Frequency and attributed causes of graft failure

Plasma creatinine concentration in those with functioning grafts

Prevalence of hypertension requiring treatment

Prevalence of cardiovascular events and disease (see Appendix 4)

Plasma cholesterol (whether is it useful to measure and/or treat raised plasma cholesterol concentrations post-transplant remains controversial. Until the results of long term controlled trials are available, plasma cholesterol should be measured annually to allow correlation with outcome)

Prevalence of malignant disease of all types, including skin cancers

Number of pregnancies, spontaneous and therapeutic abortion rates and complications of pregnancy (eg Caesarian section rate)

   
A4.7 (Para 7.46)

Survival remains the ultimate measure of the success of renal replacement therapy for end stage renal failure (ESRF), a universally fatal condition. It is used therefore as a measure of quality to compare performance, both within and between centres providing such treatment. However, the cost and outcomes of providing the service are influenced by the age and general health of patients accepted for treatment (see 4.10), so any comparative audit or setting of standards in dialysis or transplantation must take account of factors present in the patients, other than the renal failure itself.

It is important also to include survival and other information on very frail or very ill patients who die within a few weeks of beginning dialysis treatment (see Chapters 5 and 6). This has not been universal practice either in the UK or internationally. For example, European data from the ERA Registry include such patients, whereas the US Renal Data System excludes all those who do not survive to 90 days from beginning dialysis. However, the ERA Registry, although it has analysed the effects of age in some detail (Valderrábano et al 1995), has not taken comorbid conditions into account other than diabetes mellitus and systemic disease involving the kidney (eg lupus).

The importance of these considerations continues to increase as older patients and those with other comorbid illnesses or disabilities are accepted for treatment of their ESRF. For example, the median age of those accepted for dialysis in the UK rose from 47 years in 1977 to 60 years in 1992 (Department of Health 1996a; Roderick 1997). This population includes , inevitably, a higher proportion of socially deprived, frail patients with decreased mobility and more mental disability. Comparison of global survival rate between centres or regions will be meaningless unless the influences of comorbodity and age are considered.

Survival of patients during treatment for ESRF, and general idices of mobility and well-being, have been shown to be influenced by age and by many comorbid conditions such as diabetes mellitus, ischaemic heart disease, congestive heart failure, liver disease, respiratory disease and peripheral vascular disease. The publications have emanated mostly from the United States (McLellan et al 1991, 1992; Wright 1991; Us Renal Data System 1992; Collins et al 1994) but also from the UK (Khan et al 1993, 1996) and other countries (Nicolucci et al 1992). If the severity of each condition is taken into account as well, then the complexity of the problem is evident.

The Index of Coexisting Disease (ICED) has been use in a number other medical conditions, particularly cancers (Charleson et al 1987; Bennett et al 1991), as well as hip replacement (Greenfield et al 1993), to determine its effect upon outcome. This involves calculating a weighted index of comorbidity taking into account several levels of severity; so far it has been little applied to renal disease (Nicolucci et al 1992; Athienites et al 1994).

The first edition of this standards document (Renal Association 1995) quoted the review of renal services in England completed in 1994 (Department of Health 1996a) which identified a very simplified classification of relative risk for patients undergoing treatment of ESRF, which (slightly modified) is:

Standard risk: non-diabetics under the age of 55

Medium risk: non-diabetics aged 55-64 and diabetics aged 15-54

High risk: non-diabetics 65 and older, diabetics 55 and older, and all HIV positive patients

This simple approach still seems applicable in making comparisons, and the targets throughout this present document have been set only for standard risk patients, ie non-diabetic, HIV negative, <55 years can be regarded only as an interim classification until individual comorbidities can be allocated specific weightings in calculating overall risk. The UK Renal Registry intends to collect comorbidity data, both at entry and annually thereafter, to refine this simple approach; these data are shown below.

   
Recommendation

Data should be collected separately, medium and high risk patients under treatment for ESRF as suggested above.

The presence of the comorbid conditions listed below should be noted for all patients receiving ESRF, and the assessment repeated at least annually.

The data upon which the following definitions are based are included in the data set being collected for the UK Renal Registry.

Diabetes mellitus

Hyperglycaemia requiring treatment
OR
Diabetic microvasculopathy

   
Peripheral vascular disease

Missing peripheral pulse(s)
OR
Claudication
OR
Ischaemic ulcers
OR
Revascularisation
OR
Amputation

   
Ischaemic heart disease Known myocardial infarction
OR
Revascularisation/angioplasty
OR
Documented angina
   
Heart failure Clinical signs of congestive heart failure
OR
Ejection fraction <40% on echocardiography
   

Cerebral vascular disease

Documented cerebrovascular accident
OR
Transient ischaemic attacks
   
Liver disease Persistent enzyme evidence of hepatic dysfunction
OR
Biopsy evidence
OR
HbeAg or hepatitis C antigen(polymerase chain reaction)positive serology
   

Chronic obstructive
airways disease (COAD)/
Respiratory failure

Diagnosis no exclusion in a patient with chronic bronchiolar obstruction and hyperinflated lungs
   
Malignancy Presence of any malignant condition, other than basal cell carcinoma of the skin
   
HIV positive Positive with any recognised serological test for HIV
   
Other Inherited or congenital disorders with an impact on
survival, eg oxalosis, cystic fibrosis, Down's syndrome,
congenital heart disease
   

The position of smoking per se as a risk factor for patients with renal failure is still not clear. It will be expressed by the presence of COAD and vascular disease but for the moment it is being recorded as a separate item of data in the Renal Registry set.

We hope that the collation of these data by the UK Renal Registry will provide more accurate assessment of comorbidity than the current method which takes account only of age and diabetes.

 
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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