Health technology assessment

Citation

(2006), "Health technology assessment", Clinical Governance: An International Journal, Vol. 11 No. 2. https://doi.org/10.1108/cgij.2006.24811baf.001

Health technology assessment

The following are executive summaries of monographs published recently by the NHS R&D Health Technology Assessment programme, which publishes around 50 such reports a year. All the executive summaries and full reports are available at www.ncchta.org where they may be viewed and downloaded free of charge.Printed full versions of all monographs can be obtained at a cost of £20 each from: York Publishing Services Ltd, PO Box 642, York, YO31 7WX. Tel: 0870 1616662; Fax: 0870 1616663; E-mail: ncchta@yps-publishing.co.ukA fully searchable CD-ROM containing all the HTA monographs is also available free of charge from the above address.

The British Rheumatoid Outcome Study Group (BROSG) randomised controlled trial to compare the effectiveness and cost-effectiveness of aggressive versus symptomatic therapy in established rheumatoid arthritisD. Symmons, K. Tricker, C. Roberts, L. Davies, P. Dawes and D.L. Scott

Objectives

To examine the effectiveness and cost-effectiveness of symptomatic versus aggressive treatment in patients with established, stable rheumatoid arthritis (RA).

Design

A randomised observer-blinded controlled trial and economic evaluation with an initial assessment at randomisation and follow-ups at 12, 24 and 36 months.

Setting

Five rheumatology centres in England. The “symptomatic care” patients were managed predominantly in primary care with regular visits by a rheumatology specialist nurse. The “aggressive care” patients were managed predominantly in the hospital setting.

Patients

Patients with RA for more than five years’ duration were screened in rheumatology clinics. They were asked to participate if they had been on stable therapy for at least six months and had no evidence of systemic rheumatoid disease or other serious co-morbidity.

Interventions

The symptomatic care patients were seen at home every four months by a rheumatology specialist nurse and annually by the rheumatologist. The aim of treatment was symptom control. The aggressive care patients were seen at least every four months in hospital. Their treatment was altered (following predefined algorithms) with the aim of suppressing both clinical and laboratory evidence of joint inflammation.

Outcome measures

The main outcome measure was the Health Assessment Questionnaire (HAQ). Others included the patient and physician global assessment, pain, tender and swollen joint counts, the erythrocyte sedimentation rate and the OSRA (overall status in rheumatoid arthritis) score. X-rays of the hands and feet were performed at the beginning and end of the study. The EQ-5D was used in the health economic evaluation. Comprehensive costs were also estimated and were combined with measures of outcome to examine between-group differences.

Results

A total of 466 patients were recruited; 399 patients completed the three years of follow-up. There was a significant deterioration in physical function (HAQ) in both arms. There was no significant difference between the groups for any of the clinical outcome measures except the physician global assessment (adjusted mean difference 3.76; 95 per cent CI 0.03-7.52) and the OSRA disease activity component (adjusted mean difference 0.41; 95 per cent CI 0.01-0.71), both in favour of the aggressive arm. During the trial, second-line drug treatment was changed in 77.1 per cent of the aggressive arm and 59.0 per cent of the symptomatic arm. There were instances when the rheumatologist should have changed treatment but did not do so, usually because of mild disease activity. The symptomatic arm was associated with higher costs and higher quality-adjusted life-years (QALYs). There was a net cost of £1,517 per QALY gained for the symptomatic arm. Overall, the primary economic analysis and sensitivity analyses of the cost and QALY data indicate that symptomatic treatment is likely to be more cost-effective than aggressive treatment in 58-90 per cent of cases.

Conclusions

This trial showed no benefit of aggressive treatment in patients with stable established RA. However, it was difficult to persuade the rheumatologist and/or the patient to change treatment if the evidence of disease activity was minimal. Patients in the symptomatic arm were able to initiate changes of therapy when their symptoms deteriorated, without frequent hospital assessment. Approximately one-third of current clinic attenders with stable RA could be managed in a shared care setting with annual review by a rheumatologist and regular contact with a rheumatology nurse.

Recommendations for further research

The following areas are suggested for further research:

• •

  A trial to establish whether disease progression can be retarded in patients with mild, stable established RA using biological agents. There is evidence from the TEMPO Trial that the combination of methotrexate and etanercept can halt radiological progression in patients with active established RA. Would the same effect be seen in patients with relatively inactive disease?

• •

  Refinement of the model of shared care that was found to be cost-effective in this trial. For example, is contact with a nurse every four months (based in either hospital or primary care) essential? Could the contact be replaced by a telephone call or a postal questionnaire?

• •

  Development of a robust and fail-safe system of disease-modifying anti-rheumatic drug (DMARD) monitoring that is primary care based. If patients are going to be managed in shared care with annual review by a rheumatologist, then the DMARD monitoring should also be able to detect non-attendance for blood tests, should be able to prevent prescriptions from being issued if monitoring is not taking pace, should be able to detect abnormal results and bring them to the prescriber’s attention and should protect the nurse or doctor from having to check large numbers of normal results. Such a system should be computerised and link into both GP and hospital systems. The rheumatologist should be available to provide advice in the case of abnormal results.

• •

  Further studies to predict response to DMARDs.

• •

  Further research to establish whether there is a minimum disease activity level below which disease progression does not occur.

©2005 Crown Copyright

(D. Symmons and K. Tricker are based at the ARC Epidemiology Unit, University of Manchester, Manchester, UK. C. Roberts is based at the Biostatistics Group, University of Manchester, Manchester, UK. L. Davies is based at the Health Economics Research Unit, University of Manchester, Manchester, UK. P. Dawes is based at the Staffordshire Rheumatology Centre, Stoke-on-Trent, UK. D.L. Scott is based at the Academic Rheumatology Unit, King’s College Hospital, London, UK.)