The development of an EORTC quality of life questionnaire to assess chemotherapy-induced peripheral neuropathy: The QLQ-CIPN20

ArticleinEuropean Journal of Cancer 41(8):1135-9 · June 2005with175 Reads
DOI: 10.1016/j.ejca.2005.02.012 · Source: PubMed
Abstract
Chemotherapy-induced peripheral neuropathy (CIPN) is a common phenomenon, often resulting in serious limitations in daily functioning and compromised quality of life. Currently available toxicity grading systems typically use a combination of clinical and paraclinical parameters and relies on the judgment of clinicians and/or nurses. However, because many of the symptoms of CIPN are subjective in nature, it is only logical that an assessment of CIPN be based, at least in part, on patient self-report data. We report on the development of a patient self-report questionnaire, the CIPN20, intended to supplement the core quality of life questionnaire of the European Organization for Research and Treatment of Cancer (EORTC). Following EORTC guidelines, relevant CIPN-related issues were identified from a literature survey and interviews with health professionals (n=15) and patients (n=112). The resulting 20-item questionnaire was pre-tested in three languages and four countries and is currently being examined in a large, international clinical trial. The EORTC CIPN20 should provide valuable information on CIPN-related symptoms and functional limitations of patients exposed to potentially neurotoxic chemotherapeutic and/or neuroprotective agents.
    • "Testing also needs to be done with other neurotoxic drugs to determine the validity and reliability of the tools with other populations. Several studies collected data on patients who had received neurotoxic chemotherapy previously (Cavaletti et al., 2007; Oldenburg et al., 2006; Postma et al., 2005; Shimozuma et al., 2009; Smith et al., 2010; Wampler et al., 2006). Confounding variables may have affected the CIPN scores and skewed the data. "
    [Show abstract] [Hide abstract] ABSTRACT: Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common and often dose-limiting side effect of chemotherapy that can result in disability and poorer quality of life. However, no standardized measurement for CIPN exists. Clinicians often base decisions for dose modification or discontinuation of a chemotherapeutic agent on patient report of subjective symptoms and physical examination. Objectives: This review is designed to identify valid and reliable assessment tools that measure or assess CIPN in adult patients receiving chemotherapy. Methods: A systematic literature review was conducted using PubMed, CINAHL®, and Cochrane Library. Articles were included if their primary purpose was to evaluate the psychometric properties of scales to measure CIPN in adult patients with cancer receiving neurotoxic chemotherapeutic agents. Findings: The search yielded 143 results, with 16 articles meeting criteria for inclusion in the review. Seven unique scales and their reduced and modified versions were examined. The majority of the questionnaires were evaluated in a single tumor type, primarily with taxanes and platinum compounds. No consensus exists on the most appropriate patient self-report scale for use in the general oncology population.
    Full-text · Article · Apr 2016
    • "Additionally, early trials often relied on clinicianassessment of neuropathy, with methods such as CTCAE criteria, which have been shown to be less sensitive than patient reported outcomes. Newer trials have included patient-reported outcomes as the primary endpoints with instruments such as the EORTC QLQ-CIPN 20 or FACT/GOG-Ntx to more accurately characterize the incidence and severity of neuropathy [46, 47]. The NCI-supported trials have also exposed the inefficacy of some traditional practice approaches, thereby facilitating the abandonment of therapies that are unnecessary, costly, and potentially harmful. "
    [Show abstract] [Hide abstract] ABSTRACT: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common and debilitating complications of cancer treatment. Due to a lack of effective management options for patients with CIPN, the National Cancer Institute (NCI) sponsored a series of trials aimed at both prevention and treatment. A total of 15 such studies were approved, evaluating use of various neuro-modulatory agents which have shown benefit in other neuropathic pain states. Aside from duloxetine, none of the pharmacologic methods demonstrated therapeutic benefit for patients with CIPN. Despite these disappointing results, the series of trials revealed important lessons that have informed subsequent work. Some examples of this include the use of patient-reported symptom metrics, the elimination of traditional-yet unsubstantiated-practice approaches, and the discovery of molecular genetic predictors of neuropathy. Current inquiry is being guided by the results from these large-scale trials, and as such, stands better chance of identifying durable solutions for this treatment-limiting toxicity.
    Full-text · Article · Dec 2015
    • "Six patients in total were excluded due to biochemical features of diabetes (three), impaired glucose tolerance (one), subclinical hypothyroidism (one), and raised triglycerides (>1.7 mmol/L; one). For the grading of CIPN severity, we used the EORTC QLQ-CIPN20 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapyinduced Peripheral Neuropathy 20 module) questionnaire (Postma et al. 2005) as current evidence recognizes this as a validated 'patient-oriented' evaluation of CIPN symptoms and functional impairment (Wolf et al. 2012; Lavoie Smith et al. 2013 ). The current version of CIP20 is a 20- item patient self-reported CIPN-specific questionnaire that includes three subscales assessing sensory (nine items), motor (eight items), and autonomic symptoms (three items) with each item measured on a 1–4 Likert scale (1 being " not at all " and 4 being " very much " ). "
    [Show abstract] [Hide abstract] ABSTRACT: IntroductionThe diagnosis and quantification of chemotherapy-induced peripheral neuropathy (CIPN) remains a challenge. Conventional methods including quantitative sensory testing (QST), nerve conduction tests, and biopsy are unable to detect subclinical changes, and do not consistently correlate with severity of patients' symptoms and functional impairment. This study aims to determine the utility of the LDI (laser Doppler imager) FLARE technique in the diagnosis of CIPN and whether it correlates with symptom severity.Materials and Methods We assessed 24 patients with established CIPN [12 due to platinum analogs (PA) and 12 to Taxanes (TX)] and 24 matched healthy controls (HC). All underwent neurophysiological examination including vibration perception threshold (VPT), sural nerve amplitude (SNAP) and conduction velocity (SNCV), LDIFLARE, and fasting biochemistry. The QLQ-CIPN20 questionnaire was used to assess symptom severity.ResultsHC, combined chemotherapy (CG), PA, and TX groups were matched for age, sex, BMI, and blood pressure. The LDIFLARE was significantly reduced in CG compared to HC (P =< 0.0001), whereas SNAP (P = 0.058) and SNCV (P = 0.054) were not. The LDIFLARE correlated with the QLQ-CIPN20 symptom scores in all three categories namely, CG (P =< 0.0001), PA (P = 0.001) and TX (P = 0.027) whilst, VPT, SNAP, and SNCV did not.Conclusion Our findings suggest that the LDIFLARE technique is more helpful in confirming the diagnosis of CIPN in patients with distal sensory symptoms than current commonly used methods. Moreover, this novel test fulfils the unmet need for a diagnostic test that relates to the severity of symptoms. This may be useful in quantifying early changes in small fibre function indicating early CIPN.
    Full-text · Article · May 2015
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