Original Title: Prótesis electrónicas para la Disfemia. Efectividad y seguridad de las prótesis electrónicas en la mejora de la fluidez de la disfemia

Authors' objectives: Conduct a systematic review of the literature relative to the efficacy, effectiveness and safety of the electronic devices used in people with Stutter without other diseases and the cost-effectiveness from their use.

Authors' results and conclusions: Results: The systematic review of the efficacy, effectiveness and usefulness of devices for stuttering includes a total of 17 items. The majority, 15 of 17 studies provide evidence for the effectiveness evaluation while, available evidence about utility and acceptability is based on findings from five studies. Studies have methodological limitations in selected study population and in some cases related to the evaluation of the intervention. Selection bias was observed in the study population, more favorable to analyze the usefulness of the devices. Most studies have evaluated the effectiveness of control conditions (laboratory), and very limited in daily life Situations with the custom setting device and is based on short-term evaluations (mainly initial analysis after device’adjustment. Only one long-term study analyzes more than one year of use. To determine the usefulness of the device, the evidence is based on the answer given by questionnaires about perceived acceptability or tolerability, with at least 6 months of use of them. Any economic evaluation study on the devices for stuttering is identified. So, it is not possible to have information about the cost-effectiveness of these. In assessing the effectiveness and usefulness of devices for stuttering. All studies evaluating the effectiveness of experimental studies that are not randomized quasi-experimental design (Pre-Post). The evaluation is performed by trained and qualified personnel with the application of valid scales. The sample size of all these studies is limited to an average of 10 participants. In 4 of the 13 studies analyzed major losses occur during follow-up. Studies have methodological limitations in the study population selected. There is a lack of representativeness of the study population that is primarily seen by the presence of selection bias due to the existence of selective participation of the subjects included in the studies. And in some study limitations related to the evaluation of the intervention as improvement in the flow of speech, due to closely monitor inducing participants obtaining positive or favorable response on the effectiveness of the devices are observed. All this leads to overestimation of the actual effect and impact of the devices, quantified as reducing the rate or frequency of stuttering and improves the naturalness of speech. Although measures are taken with regard to the setting of altered auditory feedback signals are evaluated devices, such as randomization and masking sequences conditions or experimental configurations AFF evaluated with the device´s use. Not enough to reduce the limitations of the study. Another factor to consider is the small sample size in Clinical Trials; no conclusions can be extrapolated to large scale. The measure of effectiveness evaluation expressed as percentage changes or reductions marked, then correlated with mean reductions in the number of stuttering events per 100 or 300 syllables with limited clinical significance as well this potential benefit is observed only under conditions very controlled analysis in laboratories or soundproofed rooms. There is little evidence of effectiveness in real situations of everyday life. The magnitude of the observed effectiveness is high, higher for reading and monologue tasks than during conversation. In these studies demonstrated reductions are of great magnitude higher than 50%. In the study of Antipova et al demonstrated a maximum reduction during the first evaluation of 71% (95% CI 23-97% in the second evaluation and 50% (95% CI 3-88%) Meanwhile the magnitude effectiveness with the use of device for activities of daily life stands at 22%. In assessing the usefulness of the devices, selection bias is observed in the study population, more favorable to analyze the usefulness of the devices. The evidence regarding the usefulness and tolerability results observed show that overwhelmingly supports the utility of the same. Despite the widespread use of the devices by the findings of limited acceptance of its use in the future is limited. A third of the carriers refuse to continue to use devices or refer have no intention of buying one in the future. Although most of works highlight the perceived usefulness of the device, there are negative data regarding with tolerability due to presence of background noise or disturbance in a high percentage of users. Conclusions: Available evidence on the efficacy and effectiveness of devices for stuttering is based on intervention studies with methodological limitations.

Authors' methods: A systematic review of studies evaluating the efficacy, effectiveness, safety and cost-effectiveness of electronic devices for stuttering treatment has been carried out. A literature search of publications of articles, systematic reviews, in databases or data sources (EMBASE, Cochrane, Medline, Database HTA) has conducted and also it has realized a search and revision of Health Technologies Evaluations’ Reports conducted by Evaluation Agencies Health Technology, related with this topic. Stuttering patient associations and trade houses of these devices Web pages are reviewed. The studies found were initially evaluated for selection after reading the title and abstract, performing a critical reading of all selected and extraction of critical data literature, summarizing the available evidence. The search period includes studies published during the period from 2010 to January 2015. At first, studies were evaluated and were selected after reading the title and abstract, verifying the compliance with the objective of this report. Subsequently, all publications of selected literature are analyzed with critical appraisal methodology and criteria, extracting the most important data (critical data), and the available evidence are summarized.

Project Status: Completed

Year Published: 2016

URL for published report: https://www.iacs.es/wp-content/uploads/2018/03/01_IACS_Disfemias_DEF_NIPO-1.pdf

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es