Utilizing a quality of life tool to examine the presence of fatigue in subjects with diabetes mellitus.

Introduction: The prevalence of fatigue in patients with diabetes mellitus (DM) can be as high as 50 %. Physical, mental, and psychosocial components of fatigue negatively impact quality of life (QOL), morbidity and mortality. Several tools have been developed to address fatigue, but none specifically for measuring fatigue in DM.

Predictive value of a novel sub-item mortality risk score derived from the Norfolk Quality of Life in Diabetic Neuropathy questionnaire in Romanian participants with diabetes mellitus.

Aims: To evaluate whether the Norfolk Quality of Life in Diabetic Neuropathy (QOL-DN) questionnaire and the novel Norfolk Mortality Risk Score (NMRS), comprising Norfolk QOL-DN items, can identify 4-year mortality risk in individuals with diabetes.

Methods: Of 21,756 adults completing Norfolk QOL-DN in 2012, two groups of surviving and deceased patients were identified in 2016: Group 1, from a county capital and Group 2, from six small cities. NMRS was calculated in Group 1 using the 2012 scores of Norfolk QOL-DN items that discriminate between deceased and surviving participants (p < 0.

Factors influencing the quality of life over a 4-year period of time in Romanian patients with diabetes mellitus.

Aim: To evaluate the changes in quality of life (QOL), diabetic neuropathy (DN) and amputations over 4 years in patients with diabetes.

Methods: In 2012, 25,000 Romanian-translated Norfolk QOL-DN self-administered questionnaires were distributed during a cross-sectional study. Between March-December 2016, all patients identified from the 2012 cohort and enrolled in this follow-up study completed the Norfolk QOL-DN questionnaire; amputations suffered since 2012 were recorded.

Case-Control Study of Paresthesia Among World Trade Center-Exposed Community Members.

Objective: To investigate whether paresthesia of the lower extremities following exposure to the World Trade Center (WTC) disaster was associated with signs of neuropathy, metabolic abnormalities, or neurotoxin exposures.

Methods: Case-control study comparing WTC-exposed paresthesia cases with "clinic controls" (WTC-exposed subjects without paresthesias), and "community controls" (WTC-unexposed persons).

Results: Neurological histories and examination findings were significantly worse in cases than controls.

Development and Validation of the Norfolk Quality of Life Fatigue Tool (QOL-F): A New Measure of Perception of Fatigue.

Objectives: To design a questionnaire to evaluate and distinguish between cognitive and physical aspects of fatigue in different age groups of "nondiseased" people and guide appropriate prevention and interventions for the impact of frailty occurring in normative aging.

Study Design And Participants: The Norfolk QOL-Fatigue (QOL-F) with items of cognitive and physical fatigue, anxiety, and depression from validated questionnaires including items from the Patient-Reported Outcomes Measure Information System (PROMIS) databank was developed. The preliminary QOL-F was administered to 409 healthy multiethnic local participants (30-80 years old) in 5 age groups.

Delay between Onset of Symptoms and Seeking Physician Intervention Increases Risk of Diabetic Foot Complications: Results of a Cross-Sectional Population-Based Survey.

We present a post hoc analysis of 17,530 questionnaires collected as part of the 2012 screening for neuropathy using Norfolk Quality of Life tool in patients with diabetes in Romania, to assess the impact on foot complications of time between the onset of symptoms of diabetes/its complications and the physician visit. Odds ratios (ORs) for self-reporting neuropathy increased from 1.16 (95% CI: 1.

Capsaicin 8% patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy: a randomised, 52-week, open-label, safety study.

Background: This 52-week study evaluated the long-term safety and tolerability of capsaicin 8% w/w (179 mg) patch repeat treatment plus standard of care (SOC) versus SOC alone in painful diabetic peripheral neuropathy (PDPN).

Methods: Phase 3, multinational, open-label, randomised, controlled, 52-week safety study, conducted in Europe. Patients were randomised to capsaicin 8% patch repeat treatment (30 or 60 min; 1-7 treatments with ≥ 8-week intervals) to painful areas of the feet plus SOC, or SOC alone.

Clinical measures in transthyretin familial amyloid polyneuropathy.

Introduction: This observational, cross-sectional, single-center study aimed to identify instruments capable of measuring disease progression in transthyretin familial amyloid polyneuropathy (TTR-FAP).

Methods: The relationship between disease stage and Neuropathy Impairment Score-Lower Limbs (NIS-LL) and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) total score was assessed in 61 (stages 1-3) patients with TTR-FAP (V30M variant) and 16 healthy controls. Composite measures of large- and small-nerve fiber function, and modified body mass index (mBMI) were also assessed.

Epidemiology of Diabetic Foot Ulcers and Amputations in Romania: Results of a Cross-Sectional Quality of Life Questionnaire Based Survey.

This is a post hoc analysis of quality of life in diabetic neuropathy patients in a cross-sectional survey performed in 2012 in Romania, using the Norfolk QOL-DN in which 21,756 patients with self-reported diabetes were enrolled. This current analysis aims to expand research on the diabetic foot and to provide an update on the number of foot ulcers found in Romania. Of the 21,174 patients included in this analysis, 14.

Walking-Induced Fatigue Leads to Increased Falls Risk in Older Adults.

Background: For older adults, falls are a serious health problem, with more than 30% of people older than 65 suffering a fall at least once a year. One element often overlooked in the assessment of falls is whether a person's balance, walking ability, and overall falls risk is affected by performing activities of daily living such as walking.

Objective: This study assessed the immediate impact of incline walking at a moderate pace on falls risk, leg strength, reaction time, gait, and balance in 75 healthy adults from 30 to 79 years of age.

Detection of undisclosed neuropathy and assessment of its impact on quality of life: a survey in 25,000 Romanian patients with diabetes.

Aims: The objective of this cross-sectional survey was to capture undiagnosed neuropathy in Romanian patients with self-reported diabetes using Norfolk QoL-DN as a screening tool and to assess its impact on quality of life (QoL).

Methods: 25,000 Romanian-translated, validated Norfolk QoL-DN questionnaires were distributed between June and December 2012. 21,261 patients who self-reported diabetes and answered questions related to neuropathy, ulceration, gangrene and amputation were included in the analysis.

Falls risk in older adults with type 2 diabetes.

Falls are a major health issue for older adults, especially for those who develop type 2 diabetes who must contend with age-related declines in balance, muscle strength, and walking ability. They must also contend with health-related issues specific to the disease process. Given the general association between these variables and falls, being able to identify which measures negatively impact on balance in older diabetic persons is a critical step.

Norfolk QOL-DN: validation of a patient reported outcome measure in transthyretin familial amyloid polyneuropathy.

The Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire is an instrument to assess QOL in diabetic polyneuropathy. The objective of this observational, cross-sectional study in 61 patients with V30M transthyretin familial amyloid polyneuropathy (TTR-FAP) and 16 healthy volunteers was to validate the Norfolk QOL-DN for assessment of QOL in TTR-FAP. Comparisons were conducted to identify the best items to discriminate disease stages and assess which individual Norfolk domains (symptoms, large fiber, small fiber, autonomic, and activities of daily living) would be most affected by disease stage.

Quality of life and objective measures of diabetic neuropathy in a prospective placebo-controlled trial of ruboxistaurin and topiramate.

Background: The Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QOL-DN) is a validated comprehensive questionnaire designed to capture the entire spectrum of DN related to large fiber, small fiber, and autonomic neuropathy not captured in existing instruments. We aimed to determine if the Norfolk QOL-DN could be used to capture changes in QOL that correlate with nerve fiber-specific objective measures in a placebo-controlled trial of two agents that affect different nerve fibers.

Methods: Sixty patients with DN were allocated to treatment on ruboxistaurin (RBX) (n = 18), topiramate (TPX) (n = 18), or placebo (n = 18).

Measuring the relationship of quality of life and health status, including tumor burden, symptoms, and biochemical measures in patients with neuroendocrine tumors.

The measurement of health-related quality of life (HRQOL) has become essential for evaluating the impact of neuroendocrine tumors (NETs) on symptoms and social, emotional, psychological, and physical functioning of patients who harbor these tumors. This article describes instruments that have been developed to capture the spectrum of symptoms and the impact of the disease on their overall well-being. The authors discuss the importance of adequate sensitivity, specificity, and reproducibility and the value of psychometric factor analysis to explore the domains that embrace the manifestations of these tumors as well as aspects of the instruments that reflect tumor burden, biochemical, and hormonal status.

German-translated Norfolk quality of life (QOL-DN) identifies the same factors as the English version of the tool and discriminates different levels of neuropathy severity.

Background: The development and validation of Norfolk QOL-DN, a fiber-specific, quality-of-life tool for diabetic neuropathy, was published previously (Part 1). This study (Part 2) defines the psychometric properties of the German-translated Norfolk QOL-DN in a large multicenter (96 sites) population with neuropathy ranging from minimal to severe, comparing them with those in the original English/American version in a 30-center European/North American population with mild neuropathy; determines the power of the German-translated version in a five-staged diabetic peripheral neuropathy (DPN) German population to discriminate different levels of neuropathy severity; and establishes factors having the greatest impact on QOL.

Methods: One hundred eighty-six German patients were assessed: asymptomatic of DPN (n = 40), symptomatic (n = 46), DN with foot-ulcer history (n = 32), DN with amputations (n = 22), and DN amputation history (n = 46).

Development of the Norfolk quality of life tool for assessing patients with neuroendocrine tumors.

Objective: To develop a disease-specific questionnaire for identifying domains having the greatest impact on the quality of life (QOL) of patients with neuroendocrine tumors (NETS).

Methods: Patient responses to clinical interviews provided an 80-item initial pool for the development of the QOL-NET. The Delphi panel reviewed the items for content validity; the patient focus group reviewed the items for content/readability.

Validation of serum versus plasma measurements of chromogranin a levels in patients with carcinoid tumors: lack of correlation between absolute chromogranin a levels and symptom frequency.

Objective: Chromogranin A (CGA) levels are used to confirm the diagnosis and monitor the course of patients with neuroendocrine tumors. Chromogranin A levels are significantly reduced when patients are acutely treated with octreotide; however, limited data are available that correlates octreotide long-acting repeatable (LAR) dose or steady state octreotide blood levels to the absolute value of serum or plasma CGA.

Methods: Plasma, serum, and clinical information on carcinoid syndrome symptoms were collected anonymously from 40 patients treated with long-term octreotide LAR therapy for carcinoid syndrome.

Effect of octreotide LAR dose and weight on octreotide blood levels in patients with neuroendocrine tumors.

Objectives: Octreotide long acting repeatable (LAR) is widely used for the control of symptoms of functional neuroendocrine tumors. At doses of 30 mg/mo, up to 40% of patients require subcutaneous octreotide "rescue" and up to 40% of patients are given more than 30 mg of LAR/mo. Octreotide acetate binds to the sst2 receptor with an affinity (Kd) of approximately 1 x 10(-9) mol/L (approximately equal to 1000 pg/mL), but higher (approximately equal to 10,000 pg/mL) concentrations of octreotide are required to completely saturate this receptor.

The development and validation of the Norfolk QOL-DN, a new measure of patients' perception of the effects of diabetes and diabetic neuropathy.

Background: This study was designed to develop and validate a patient-reported outcomes measure, sensitive to the different features of diabetic neuropathy (DN)-small fiber, large fiber, and autonomic nerve function.

Methods: The review of 1,000 structured patient interviews guided the development of 28 items pertaining specifically to the symptoms and impact of large fiber, small fiber, and autonomic nerve function. These items, in addition to 14 generic health status items and five general information items formed the 47-item Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (QOL-DN).

Prevention of the complications of diabetes.

For patients with diabetes mellitus (DM), chronic complications can be devastating. Cardiovascular illness, the major cause of morbidity and mortality among these patients, encompasses macrovascular disease, with heart attacks, strokes, and gangrene; and microvascular disease, with retinopathy, nephropathy, and neuropathy (somatic and autonomic). Macrovascular events occur earlier in individuals with DM than in people without DM, and the underlying pathologies are often more diffuse and severe.