Jennifer S Gewandter1, Roy Freeman2, Rachel A Kitt2, Guido Cavaletti2, Lynn R Gauthier2, Michael P McDermott2, Nimish A Mohile2, Supriya G Mohlie2, A Gordon Smith2, Mohamedtaki A Tejani2, Dennis C Turk2, Robert H Dworkin2. 1. From the Departments of Anesthesiology (J.S.G., R.A.K., R.H.D.), Biostatistics and Computational Biology (M.P.M.), Neurology (N.A.M., M.A.T.), and Medicine, Hematology/Oncology (S.G.M.), University of Rochester, NY; Department of Neurology (R.F.), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Experimental Neurology Unit (G.C.), School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy; Department of Family Medicine and Emergency Medicine (L.R.G.), Faculty of Medicine, Université Laval, Québec, Canada; Department of Neurology (A.G.S.), University of Utah, Salt Lake City; and Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle. jennifer_gewandter@urmc.rochester.edu. 2. From the Departments of Anesthesiology (J.S.G., R.A.K., R.H.D.), Biostatistics and Computational Biology (M.P.M.), Neurology (N.A.M., M.A.T.), and Medicine, Hematology/Oncology (S.G.M.), University of Rochester, NY; Department of Neurology (R.F.), Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; Experimental Neurology Unit (G.C.), School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy; Department of Family Medicine and Emergency Medicine (L.R.G.), Faculty of Medicine, Université Laval, Québec, Canada; Department of Neurology (A.G.S.), University of Utah, Salt Lake City; and Department of Anesthesiology and Pain Medicine (D.C.T.), University of Washington, Seattle.
Abstract
OBJECTIVE: To assess the design characteristics and reporting quality of published randomized controlled trials (RCTs) for treatments of chemotherapy-induced peripheral neuropathy (CIPN) initiated before or during chemotherapy. METHODS: In this systematic review of RCTs of preventive or symptomatic pharmacologic treatments for CIPN initiated before or during chemotherapy treatment, articles were identified by updating the PubMed search utilized in the CIPN treatment guidelines published in the Journal of Clinical Oncology in 2014. RESULTS: Thirty-eight articles were identified. The majority included only patients receiving platinum therapies (61%) and used a placebo control (79%). Common exclusion criteria were preexisting neuropathy (84%), diabetes (55%), and receiving treatments that could potentially improve neuropathy symptoms (45%). Ninety-five percent of studies initiated the experimental treatment before CIPN symptoms occurred. Although 58% of articles identified a primary outcome measure (POM), only 32% specified a primary analysis. Approximately half (54%) of the POMs were patient-reported outcome measures of symptoms and functional impairment. Other POMs included composite measures of symptoms and clinician-rated signs (23%) and vibration tests (14%). Only 32% of articles indicated how data from participants who prematurely discontinued chemotherapy were analyzed, and 21% and 29% reported the number of participants who discontinued chemotherapy due to neuropathy or other/unspecified reasons, respectively. CONCLUSIONS: These data identify reporting practices that could be improved in order to enhance readers' ability to critically evaluate RCTs of CIPN treatments and use the findings to inform the design of future studies and clinical practice. Reporting recommendations are provided.
OBJECTIVE: To assess the design characteristics and reporting quality of published randomized controlled trials (RCTs) for treatments of chemotherapy-induced peripheral neuropathy (CIPN) initiated before or during chemotherapy. METHODS: In this systematic review of RCTs of preventive or symptomatic pharmacologic treatments for CIPN initiated before or during chemotherapy treatment, articles were identified by updating the PubMed search utilized in the CIPN treatment guidelines published in the Journal of Clinical Oncology in 2014. RESULTS: Thirty-eight articles were identified. The majority included only patients receiving platinum therapies (61%) and used a placebo control (79%). Common exclusion criteria were preexisting neuropathy (84%), diabetes (55%), and receiving treatments that could potentially improve neuropathy symptoms (45%). Ninety-five percent of studies initiated the experimental treatment before CIPN symptoms occurred. Although 58% of articles identified a primary outcome measure (POM), only 32% specified a primary analysis. Approximately half (54%) of the POMs were patient-reported outcome measures of symptoms and functional impairment. Other POMs included composite measures of symptoms and clinician-rated signs (23%) and vibration tests (14%). Only 32% of articles indicated how data from participants who prematurely discontinued chemotherapy were analyzed, and 21% and 29% reported the number of participants who discontinued chemotherapy due to neuropathy or other/unspecified reasons, respectively. CONCLUSIONS: These data identify reporting practices that could be improved in order to enhance readers' ability to critically evaluate RCTs of CIPN treatments and use the findings to inform the design of future studies and clinical practice. Reporting recommendations are provided.
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