Dataset Information

RimabotulinumtoxinB in sialorrhea: systematic review of clinical trials.

ABSTRACT: OBJECTIVE:The aim of this study was to examine the efficacy, safety and dosing practices of rimabotulinumtoxinB (BoNT-B) for the treatment of patients with sialorrhea based on a systematic review of clinical trials. METHODS:A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of BoNT-B for the treatment of sialorrhea published in English between January 1999 and December 2015. Medical literature databases (PubMed, Cochrane Library, and EMBASE) were searched and a total of 41 records were identified. Of these, six primary publications that evaluated BoNT-B for the treatment of sialorrhea met criteria and were included in the final data report. SYNTHESIS:Total BoNT-B doses ranged from 1500 to 4000 units for sialorrhea. Most of the studies in sialorrhea showed statistically significant benefits of BoNT-B versus placebo (range 4-19.2 weeks). BoNT-B was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Adverse events considered potentially associated with BoNT-B included: dry mouth, change in saliva thickness, mild transient dysphagia, mild weakness of chewing and diarrhea. CONCLUSIONS:BoNT-B significantly reduces sialorrhea at doses between 1500 and 4000 units. The relatively mild dose-dependent adverse events suggest both direct and remote toxin effects.

SUBMITTER: Dashtipour K

PROVIDER: S-EPMC5460542 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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RimabotulinumtoxinB in sialorrhea: systematic review of clinical trials.

Dashtipour Khashayar K Bhidayasiri Roongroj R Chen Jack J JJ Jabbari Bahman B Lew Mark M Torres-Russotto Diego D

Journal of clinical movement disorders 20170606

<h4>Objective</h4>The aim of this study was to examine the efficacy, safety and dosing practices of rimabotulinumtoxinB (BoNT-B) for the treatment of patients with sialorrhea based on a systematic review of clinical trials.<h4>Methods</h4>A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of BoNT-B for the treatment of sialorrhea published in English between January 1999 and December 2015. Medical literature databases (Pub ...[more]

PMID: 28593050

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Project description:INTRODUCTION:Stakeholder engagement is an essential component of HIV clinical trials. We define stakeholder engagement as an input by individuals or groups with an interest in HIV clinical trials to inform the design or conduct of said trials. Despite its value, stakeholder engagement to inform HIV clinical trials has not been rigorously examined. The purpose of our systematic review is to examine stakeholder engagement for HIV clinical trials and compare it to the recommendations of the UNAIDS/AVAC Good Participatory Practice (GPP) guidelines. METHODS:We used the PRISMA checklist and identified English language studies describing stakeholder engagement to inform HIV clinical trials. Four databases (PubMed, Ovid, CINAHL and Web of Science) and six journals were searched, with additional studies identified using handsearching and expert input. Two independent reviewers examined citations, abstracts and full texts. Data were extracted on country, engagement methods, stakeholder types and purpose of stakeholder engagement. Based on the GPP guidelines, we examined how frequently stakeholder engagement was conducted to inform clinical trial research question development, protocol development, recruitment, enrolment, follow-up, results and dissemination. RESULTS AND DISCUSSION:Of the 917 citations identified, 108 studies were included in the analysis. Forty-eight studies (44.4%) described stakeholder engagement in high-income countries, thirty (27.8%) in middle-income countries and nine (8.3%) in low-income countries. Fourteen methods for stakeholder engagement were identified, including individual (e.g. interviews) and group (e.g. community advisory boards) strategies. Thirty-five types of stakeholders were engaged, with approximately half of the studies (60; 55.6%) engaging HIV-affected community stakeholders (e.g. people living with HIV, at-risk or related populations of interest). We observed greater frequency of stakeholder engagement to inform protocol development (49 studies; 45.4%) and trial recruitment (47 studies; 43.5%). Fewer studies described stakeholder engagement to inform post-trial processes related to trial results (3; 2.8%) and dissemination (11; 10.2%). CONCLUSIONS:Our findings identify important directions for future stakeholder engagement research and suggestions for policy. Most notably, we found that stakeholder engagement was more frequently conducted to inform early stages of HIV clinical trials compared to later stages. In order to meet recommendations established in the GPP guidelines, greater stakeholder engagement across all clinical trial stages is needed.

Project description:BACKGROUND: Misclassification of adverse events in clinical trials can sometimes have serious consequences. Therefore, each of the many steps involved, from a patient's adverse experience to presentation in tables in publications, should be as standardised as possible, minimising the scope for interpretation. Adverse events are categorised by a predefined dictionary, e.g. MedDRA, which is updated biannually with many new categories. The objective of this paper is to study interobserver variation and other challenges of coding. METHODS: Systematic review using PRISMA. We searched PubMed, EMBASE and The Cochrane Library. All studies were screened for eligibility by two authors. RESULTS: Our search returned 520 unique studies of which 12 were included. Only one study investigated interobserver variation. It reported that 12% of the codes were evaluated differently by two coders. Independent physicians found that 8% of all the codes deviated from the original description. Other studies found that product summaries could be greatly affected by the choice of dictionary. With the introduction of MedDRA, it seems to have become harder to identify adverse events statistically because each code is divided in subgroups. To account for this, lumping techniques have been developed but are rarely used, and guidance on when to use them is vague. An additional challenge is that adverse events are censored if they already occurred in the run-in period of a trial. As there are more than 26 ways of determining whether an event has already occurred, this can lead to bias, particularly because data analysis is rarely performed blindly. CONCLUSION: There is a lack of evidence that coding of adverse events is a reliable, unbiased and reproducible process. The increase in categories has made detecting adverse events harder, potentially compromising safety. It is crucial that readers of medical publications are aware of these challenges. Comprehensive interobserver studies are needed.

Dataset Information

RimabotulinumtoxinB in sialorrhea: systematic review of clinical trials.

Publications

RimabotulinumtoxinB in sialorrhea: systematic review of clinical trials.

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