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A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain.

ABSTRACT: To examine the efficacy and safety of Prosaptide (PRO) for the treatment of painful HIV-associated sensory neuropathies (HIV-SN).A randomized, double-blind, placebo-controlled, multicenter study in participants with sensory neuropathy. Pain modulating therapy was discontinued prior to baseline. Participants were stratified by sural sensory nerve action potential (SNAP) amplitude. Participants were trained to use an electronic diary (ED) to record pain.Peripheral neuropathies are common complications of HIV infection. The pathogenesis is unknown and currently treatments are restricted to symptomatic measures. We examined PRO against placebo (PBO) for treatment of painful HIV-SN and performed a post-hoc evaluation of an electronic diary (ED) to record HIV-associated neuropathic pain.Eligible participants included adults with neurologist-confirmed painful HIV-SN.2, 4, 8, or 16 mg/d PRO or PBO administered via subcutaneous (SC) injection for six weeks. Neurotoxic antiretroviral drug usage was held constant.Changes from baseline in the weekly average of evaluable daily random prompts measuring pain using the Gracely pain scale and adverse events.237 participants were randomized. The study was stopped after a planned futility analysis. There were no between-group differences in the frequency of adverse events or laboratory toxicities. The 6-week mean (sd) Gracely pain scale changes were -0.12 (0.23), -0.24 (0.35), -0.15 (0.32), -0.18 (0.34), and -0.18 (0.32) for the 2, 4, 8, 16 mg, and PBO arms respectively. A similar variability of pain changes recorded using the ED were noted compared to previous trials that used paper collection methods.6-week treatment with PRO was safe but not effective at reducing HIV-associated neuropathic pain. Use of an ED to record neuropathic pain is novel in HIV-SN, resulted in reasonable compliance in recording pain data, but did not decrease the variability of pain scores compared to historical paper collection methods.Current Controlled Trials NCT00286377.

SUBMITTER: Evans SR

PROVIDER: S-EPMC1919427 | biostudies-literature | 2007 Jul

REPOSITORIES: biostudies-literature

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A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain.

Evans Scott R SR Simpson David M DM Kitch Douglas W DW King Agnes A Clifford David B DB Cohen Bruce A BA McArthur Justin C JC

PloS one 20070725 6

<h4>Objectives</h4>To examine the efficacy and safety of Prosaptide (PRO) for the treatment of painful HIV-associated sensory neuropathies (HIV-SN).<h4>Design</h4>A randomized, double-blind, placebo-controlled, multicenter study in participants with sensory neuropathy. Pain modulating therapy was discontinued prior to baseline. Participants were stratified by sural sensory nerve action potential (SNAP) amplitude. Participants were trained to use an electronic diary (ED) to record pain.<h4>Settin ...[more]

PMID: 17653259

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Project description:BACKGROUND:The transition to the electronic health record (EHR) has brought forth a rapid cultural shift in the world of medicine, presenting both new challenges as well as opportunities for improving health care. As clinicians work to adapt to the changes imposed by the EHR, identification of best practices around the clinically excellent use of the EHR is needed. OBJECTIVE:Using the domains of clinical excellence previously defined by the Johns Hopkins Miller Coulson Academy of Clinical Excellence, this review aims to identify best practices around the clinically excellent use of the EHR. METHODS:The authors searched the PubMed database, using keywords related to clinical excellence domains and the EHR, to capture the English-language, peer-reviewed literature published between January 1, 2000, and August 2, 2016. One author independently reviewed each article and extracted relevant data. RESULTS:The search identified 606 titles, with the majority (393/606, 64.9%) in the domain of communication and interpersonal skills. Twenty-eight of the 606 (4.6%) titles were excluded from full-text review, primarily due to lack of availability of the full-text article. The remaining 578 full-text articles reviewed were related to clinical excellence generally (3/578, 0.5%) or the specific domains of communication and interpersonal skills (380/578, 65.7%), diagnostic acumen (31/578, 5.4%), skillful negotiation of the health care system (4/578, 0.7%), scholarly approach to clinical practice (41/578, 7.1%), professionalism and humanism (2/578, 0.4%), knowledge (97/578, 16.8%), and passion for clinical medicine (20/578, 3.5%). CONCLUSIONS:Results suggest that as familiarity and expertise are developed, clinicians are leveraging the EHR to provide clinically excellent care. Best practices identified included deliberate physical configuration of the clinical space to involve sharing the screen with patients and limiting EHR use during difficult and emotional topics. Promising horizons for the EHR include the ability to augment participation in pragmatic trials, identify adverse drug effects, correlate genomic data to clinical outcomes, and follow data-driven guidelines. Clinician and patient satisfaction with the EHR has generally improved with time, and hopefully continued clinician, and patient input will lead to a system that satisfies all.

Dataset Information

A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain.

Publications

A randomized trial evaluating Prosaptide for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain.

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