IMPAIRMENT, DISABILITY, OR HANDICAP IN PERIPHERAL NEUROPATHY - ANALYSIS OF THE USE OF OUTCOME MEASURES IN CLINICAL-TRIALS IN PATIENTS WITH PERIPHERAL NEUROPATHIES

被引:19
作者
MOLENAAR, DSM [1 ]
DEHAAN, R [1 ]
VERMEULEN, M [1 ]
机构
[1] UNIV AMSTERDAM, ACAD MED CTR, DEPT CLIN EPIDEMIOL & BIOSTAT, AMSTERDAM, NETHERLANDS
关键词
TREATMENT OUTCOME; PERIPHERAL NERVOUS SYSTEM DISEASES; RANDOMIZED CONTROLLED TRIAL;
D O I
10.1136/jnnp.59.2.165
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Outcome measures can be classified into measures of impairment, disability, and handicap. To investigate the biological effect of treatment, measures of impairment are appropriate. Studies investigating whether patients benefit from treatment in terms of improvement of functional health, however, require disability or handicap measures. In a review of the medical Literature between 1978, and 1993, 73 controlled intervention studies in patients with peripheral neuropathies were found. Disability or handicap measures were used in two of 54 studies in patients with diabetic neuropathy, in two of six studies in patients with chronic inflammatory demyelinating polyneuropathy, in none of five studies in a mixed group of patients, and in all eight studies in patients with Guillain-Barre syndrome. The limited use of disability and handicap measures in patients with diabetic and mixed neuropathies can be explained by the experimental nature of most studies. In four of six studies, however, in patients with chronic inflammatory demyelinating polyneuropathy or neuropathy associated with monoclonal gammopathy that were designed to assess effectiveness of treatment, the choice of outcome measures was not appropriate. It is concluded that in the design of intervention studies in patients with peripheral neuropathy more attention should be paid to a proper choice of suitable outcome measures to assess the effectiveness of treatment.
引用
收藏
页码:165 / 169
页数:5
相关论文
共 34 条
[1]  
Liniger C., Pemet A., Moody J.F., Assal J.P., Effect of gangliosides on diabetic peripheral neuropathy. Diabetes Res Clin Prac, 7, (1989)
[2]  
Martyn C.N., Reid W., Young R.J., Ewing D.J., Clarke B.F., Six-month treatment with sorbinil in asymptomatic diabetic neuropathy. Failure to improve abnormal nerve function, Diabetes, 36, (1987)
[3]  
Max M.B., Culnane M., Schafer S.C., Gracely R.H., Walther D.J., Smoller B., Amitriptyline relieves diabetic neuropathy pain in patients with normal or depressed mood, Neurology, 37, (1987)
[4]  
Max M.B., Lynch S.A., Muir J., Shoaf S.E., Smoller B., Dubner R., Effects of desipramine, amitriptyline, and fluoxetine on pain in diabetic neuropathy, 326, (1992)
[5]  
Max M.B., Kishore-Kumar R., Schafer S.C., Meister B., Gracely R.H., Efficacy of desipramine in painful diabetic neuropathy: a placebo-controlled trial, Pain, 45, (1991)
[6]  
Mendel C.M., Klein R.F., Chappell D.A., A trial of amitriptyline and fluphenazine in the treatment of painful diabetic neuropathy, JAMA, 255, (1986)
[7]  
Naarden A., Davidson J., Harris L., Moore J., DeFelice S., Treatment of painful diabetic polyneuropathy with mixed gangliosides, Adv Exp Med Biol, 174, (1984)
[8]  
O'Hare J.P., Morgan M.H., Alden P., Chissel S., O'Brien I.A., Corrall R.J., Aldose reductase inhibition in diabetic neuropathy: clinical and neurophysiological studies of one year's treatment with sorbinil, Diabet Med, 5, (1988)
[9]  
Sachse G., Wilhms B., Efficacy of thioctic acid in the therapy of peripheral diabetic neuropathy, Horm Metab Res Suppl, 9, (1980)
[10]  
Salway J.G., Whitehead L., Finnegan J.A., Karunanayaka A., Barnett D., Payne R.B., Effect of myo-inositol on peripheral-nerve function in diabetes, Lancet, ii:, (1978)