The Development and Validation of the Norfolk QOL-DN, a New Measure of Patients' Perception of the Effects of Diabetes and Diabetic Neuropathy

Vinik, Etta J.; Hayes, Risa P.; Oglesby, Alan; Bastyr, Edward J.; Barlow, Patricia M.; Ford-Molvik, Stephanie L.; Vinik, Aaron I.

doi:10.1089/dia.2005.7.497

Cited by 202 publications

(166 citation statements)

References 15 publications

(12 reference statements)

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“…Neuropathy Impairment Score-Lower Limbs (NIS-LL) [25], total quality of life (TQOL) as measured using the Norfolk Quality of Life-Diabetic Neuropathy questionnaire (Norfolk QOL-DN) [26,27], Karnofsky performance status (not assessed in the ATTRV30M parent studies), body mass index (BMI) and modified BMI (mBMI) [28] were evaluated at 6-month intervals during the parent studies and at 12-month intervals during the on-going extension study. The NIS-LL and its three components (sensation, reflexes and muscle weakness) assess the severity of peripheral neuropathy in the lower limbs and are considered valid, reliable measures of disease severity [29].…”

Section: Outcome Measuresmentioning

confidence: 99%

“…c The NIS-LL, a clinical assessment scoring muscle weakness, sensory loss and decrease of muscle stretch reflexes, ranges from 0 (normal) to 88 (total impairment) [25]. d NIS-LL muscle weakness, a subscore of the NIS-LL, ranges from 0 to 64. e Norfolk QOL-DN TQOL, a 35-item patient-rated questionnaire to assess the impact of neuropathy on QOL, ranges from -2 (best QOL) to 138 (worst QOL) [26,27]. f One patient in the ATTRV30M placebo-to-tafamidis group had a missing baseline TQOL score.…”

Section: Attrv30mmentioning

confidence: 99%

See 1 more Smart Citation

Long-term safety and efficacy of tafamidis for the treatment of hereditary transthyretin amyloid polyneuropathy: results up to 6 years

Barroso

Judge

Ebede

et al. 2017

Amyloid

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Background: The objective of the present study was to evaluate the long-term safety and efficacy of tafamidis in treating hereditary transthyretin amyloid polyneuropathy. Methods: A prospectively planned interim analysis was conducted on an on-going, phase III, open-label extension study following an 18-month, randomized, controlled study and 12-month, open-label extension study in ATTRV30M patients and a single-arm, open-label study in non-ATTRV30M patients. Thirtyseven ATTRV30M patients received placebo for 18 months, then switched to tafamidis and 38 ATTRV30M patients and 18 non-ATTRV30M patients continuously received tafamidis from day 1, up to 6 years. Results: Long-term tafamidis was associated with a favourable safety/tolerability profile, without any unexpected adverse events. Patients initiating tafamidis at the start of the randomized study had less polyneuropathy progression versus those switching to tafamidis following 18 months of placebo and were less likely to progress to the next ambulatory stage after up to 6 years follow-up. In the patients who switched from placebo to tafamidis, polyneuropathy progression and deterioration in quality of life slowed significantly during long-term tafamidis treatment as compared with the previous placebo treatment. In non-ATTRV30M patients, some polyneuropathy progression was observed across all efficacy measures. Conclusions: These data provide evidence for the long-term (up to 6 years) safety and efficacy of tafamidis. ClinicalTrials.gov: NCT00925002

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Section: Outcome Measuresmentioning

confidence: 99%

Section: Attrv30mmentioning

confidence: 99%

Long-term safety and efficacy of tafamidis for the treatment of hereditary transthyretin amyloid polyneuropathy: results up to 6 years

Barroso

Judge

Ebede

et al. 2017

Amyloid

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show abstract

“…Patients completed the self-administered Norfolk Quality-of-Life Questionnaire for Diabetic Neuropathy (QOL-DN), which has been shown to provide good to excellent correlations between symptomatic DPN and quality of life from the patient's perspective (30). The Norfolk QOL-DN is composed of questions related to patients' signs and symptoms, as well as to the impact of DPN on patients' activities of daily life.…”

Section: Efficacy Measurementsmentioning

confidence: 99%

A 6-Month, Randomized, Double-Masked, Placebo-Controlled Study Evaluating the Effects of the Protein Kinase C-β Inhibitor Ruboxistaurin on Skin Microvascular Blood Flow and Other Measures of Diabetic Peripheral Neuropathy

et al. 2007

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OBJECTIVE -Diabetes leads to protein kinase C (PKC)-␤ overactivation and microvascular dysfunction, possibly resulting in disordered skin microvascular blood flow (SkBF) and other changes observed in diabetic peripheral neuropathy (DPN) patients. We investigate the effects of the isoform-selective PKC-␤ inhibitor ruboxistaurin mesylate on neurovascular function and other measures of DPN.RESEARCH DESIGN AND METHODS -Endothelium-dependent and C fibermediated SkBF, sensory symptoms, neurological deficits, nerve fiber morphometry, quantitative sensory and autonomic function testing, nerve conduction studies, quality of life (using the Norfolk Quality-of-Life Questionnaire for Diabetic Neuropathy [QOL-DN]), and adverse events were evaluated for 20 placebo-and 20 ruboxistaurin-treated (32 mg/day) DPN patients (aged Ն18 years; with type 1 or type 2 diabetes and A1C Յ11%) during a randomized, doublemasked, single-site, 6-month study.RESULTS -Endothelium-dependent (ϩ78.2%, P Ͻ 0.03) and C fiber-mediated (ϩ56.4%, P Ͻ 0.03) SkBF at the distal calf increased from baseline to end point. Significant improvements from baseline within the ruboxistaurin group were also observed for the Neuropathy Total Symptom Score-6 (NTSS-6) (3 months Ϫ48.3%, P ϭ 0.01; end point Ϫ66.0%, P Ͻ 0.0006) and the Norfolk QOL-DN symptom subscore and total score (end point Ϫ41.2%, P ϭ 0.01, and Ϫ41.0, P ϭ 0.04, respectively). Between-group differences in baseline-to-end point change were observed for NTSS-6 total score (placebo Ϫ13.1%; ruboxistaurin Ϫ66.0%, P Ͻ 0.03) and the Norfolk QOL-DN symptom subscore (placebo Ϫ4.0%; ruboxistaurin Ϫ41.2%, P ϭ 0.041). No significant ruboxistaurin effects were demonstrated for the remaining efficacy measures. Adverse events were consistent with those observed in previous ruboxistaurin studies.CONCLUSIONS -In this cohort of DPN patients, ruboxistaurin enhanced SkBF at the distal calf, reduced sensory symptoms (NTSS-6), improved measures of Norfolk QOL-DN, and was well tolerated. Diabetes Care 30:896 -902, 2007

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“…The central nervous system (CNS) signs score is the sum of the number of positive cerebellar signs. The total peripheral neuropathy impairment scores and sensory scores were obtained from our clinical evaluation scoring system (Vinik et al 2005b) modifi ed from the Rochester Diabetic Neuropathy Study (Dyck et al 1992) . In this system a score of 1 or 0 is given for the presence or absence of neuropathy symptom respectively.…”

Section: Figurementioning

confidence: 99%

A 70-year-old male with peripheral neuropathy, ataxia and antigliadin antibodies shows improvement in neuropathy, but not ataxia, after intravenous immunoglobulin and gluten-free diet

Anandacoomaraswamy

Ullal

Vinik

2008

JMDH

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This is a case of a 70-year-old man with severe peripheral neuropathy, type 2 diabetes and progressively worsening cerebellar ataxia. He was found to have circulating antigliadin and antireticulin antibodies compatible with celiac disease in the absence of intestinal pathology. The peripheral neuropathy improved with a gluten-free diet, antioxidants and intravenous immunoglobulin, whereas the ataxia did not. This case illustrates the need to test for celiac disease in patients with idiopathic ataxia and peripheral neuropathy and the need for alternative therapies for ataxia.

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The Development and Validation of the Norfolk QOL-DN, a New Measure of Patients' Perception of the Effects of Diabetes and Diabetic Neuropathy

Cited by 202 publications

References 15 publications

Long-term safety and efficacy of tafamidis for the treatment of hereditary transthyretin amyloid polyneuropathy: results up to 6 years

Long-term safety and efficacy of tafamidis for the treatment of hereditary transthyretin amyloid polyneuropathy: results up to 6 years

A 6-Month, Randomized, Double-Masked, Placebo-Controlled Study Evaluating the Effects of the Protein Kinase C-β Inhibitor Ruboxistaurin on Skin Microvascular Blood Flow and Other Measures of Diabetic Peripheral Neuropathy

A 70-year-old male with peripheral neuropathy, ataxia and antigliadin antibodies shows improvement in neuropathy, but not ataxia, after intravenous immunoglobulin and gluten-free diet

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