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Challenges in Design of Multicenter Trials : End points assessed longitudinally for change and monotonicity
Oleh:
Dyck, Peter J.
;
Norell, Jane E.
;
Tritschler, Hans
;
Schuette, Klemens
;
Samigullin, Rustem
;
and Others
Jenis:
Article from Journal - ilmiah internasional
Dalam koleksi:
Diabetes Care vol. 30 no. 10 (Oct. 2007)
,
page 2619.
Topik:
DCCT
;
Diabetes Control and Complications Trial
;
DSPN
;
diabetic sensorimotor polyneuropathy
;
NC
;
nerve conduction
;
NIS(LL)
;
neuropathy impairment score of lower limbs
;
NSC
;
neuropathy symptom and change score
;
QST
;
quantitative sensation test
Ketersediaan
Perpustakaan FK
Nomor Panggil:
D05.K.2007.04
Non-tandon:
1 (dapat dipinjam: 0)
Tandon:
tidak ada
Lihat Detail Induk
Isi artikel
OBJECTIVE—Assessing clinimetric performance of diabetic sensorimotor polyneuropathy (DSPN) end points in single and multicenter trials. RESEARCH DESIGN AND METHODS—Assessed were placebo-treated patients with DSPN in the Viatris and Eli Lilly trials and an epidemiologic cohort. RESULTS—Test reproducibility in clinical trial cohorts (rI 0.7–0.85) approached that in the epidemiologic cohort (rI 0.85–0.95). Associations between pairs of end points explained <10% of the variability of data (sometimes 15–35%), being higher in the epidemiologic cohort and the Viatris trial than in the Lilly trial. Most end points did not show monotonic worsening over 4 years. However, sural nerve amplitude and peroneal motor conduction velocity did. A nerve conduction score ( 5 NC nds [5 attributes of nerve conduction expressed as normal deviates]) did not show monotonic worsening in established DSPN. In the epidemiologic cohort followed for 9.5 years, monotonic worsening of small magnitude occurred for sural amplitude, vibration detection threshold, and especially for composite quantitative sensation. CONCLUSIONS—The main reason why it is difficult to demonstrate monotonic worsening of neuropathic end points appears to be a very slow worsening of DSPN, a placebo effect for symptoms and signs, and measurement noise. Demonstrating disease progression in controlled trials of DSPN is more likely when 1) patients with developing rather than established DSPN are selected, 2) type 1 diabetic patients are preferentially recruited, 3) patients are selected who cannot or will not achieve ideal glycemic control, 4) end points chosen are known to show monotonic worsening, and 5) a restricted number of centers and expert examiners (trained, certified, using standard approaches, and reference values and interactive surveillance of tests) are used.
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