Advanced Dental Cleaning is Associated with Reduced Risk of COPD Exacerbations – A Randomized Controlled Trial

Abstract BackgroundChronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory disease whose evolution depends on the patient’s adherence to inhaler devices. Pharmacists may play a role in adherence to medication therapy in hospital and in primary care interacting with patients to provide advice on proper use. This paper presents the protocol for a randomized controlled trial conducted at a university hospital to assess the clinical impact of pharmaceutical consultations on COPD exacerbations, medical care, adherence to inhaler devices and quality of life. MethodsThis trial will include 226 COPD patients treated with inhaler devices: 94 in a control group with the usual hospital care, 66 receiving a pharmaceutical consultation at the hospital and 66 receiving several pharmaceutical consultations at their community pharmacy. The aim of these interventions is to inform patients about COPD and medication therapy, train them in the proper use of inhaler devices and make them aware of good therapeutic adherence. Patients will be randomized to either the control group or the experimental hospital group by the clinical pharmacist at the hospital. Community pharmacists will include patients in the experimental community group. All patients will be monitored for 12 months by their community pharmacists (CPs). The primary outcome is the mean number of COPD exacerbations. Secondary outcomes include the number of medical consultations, emergency visits and hospitalizations; patients’ adherence to inhaler devices and ability to use them and quality of life. DiscussionOur study is the first randomized controlled trial in France to assess the effect of pharmaceutical interventions on COPD exacerbations. Study limitations include patient recruitment and the CPs’ adherence to follow-up. Indeed, the success of this trial depends on the willingness of CPs to collect the data. However, we envisage this work as the first step towards building a network of CPs trained for clinical research. Trial registrationClinicaltrials.gov, NCT03704545. Registered on October 12th, 2018. https://clinicaltrials.gov/ct2/show/NCT03704545?cond=COPD&cntry=FR&city=nimes&draw=2&rank=1

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Circumcision and Reduced Risk of Self-Reported Penile Coital Injuries: Results From a Randomized Controlled Trial in Kisumu, Kenya

The Journal of Urology ◽

10.1016/j.juro.2010.03.015 ◽

2010 ◽

Vol 184 (1) ◽

pp. 203-209 ◽

Cited By ~ 18

Author(s):

Supriya D. Mehta ◽

John N. Krieger ◽

Kawango Agot ◽

Stephen Moses ◽

Jeckoniah O. Ndinya-Achola ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Randomized Controlled ◽

Reduced Risk

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Time-to-treatment failure in the Belgian randomized controlled trial with azithromycin for acute COPD exacerbations requiring hospitalization

10.1183/13993003.congress-2016.oa1506 ◽

2016 ◽

Author(s):

Kristina Vermeersch ◽

Stephanie Everaerts ◽

Vincent Ninane ◽

Maria Gabrovska ◽

Joseph Aumann ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Treatment Failure ◽

Controlled Trial ◽

Time To Treatment ◽

Copd Exacerbations ◽

Randomized Controlled ◽

Time To Treatment Failure

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Circumcision and Reduced Risk of Self-Reported Penile Coital Injuries: Results From a Randomized Controlled Trial in Kisumu, Kenya

Yearbook of Obstetrics Gynecology and Women s Health ◽

10.1016/j.yobg.2011.05.174 ◽

2011 ◽

Vol 2011 ◽

pp. 191-192

Author(s):

L.P. Shulman

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Randomized Controlled ◽

Reduced Risk

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Treatment Fidelity Procedures for an Aphasia Intervention Within a Randomized Controlled Trial: Design, Feasibility, and Results

American Journal of Speech-Language Pathology ◽

10.1044/2019_ajslp-cac48-18-0227 ◽

2020 ◽

Vol 29 (1S) ◽

pp. 412-424

Author(s):

Elissa L. Conlon ◽

Emily J. Braun ◽

Edna M. Babbitt ◽

Leora R. Cherney

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Treatment Protocol ◽

Treatment Fidelity ◽

Protocol Adherence ◽

Study Condition ◽

Randomized Controlled ◽

Aphasia Therapy ◽

Percent Accuracy ◽

Over Time

Purpose This study reports on the treatment fidelity procedures implemented during a 5-year randomized controlled trial comparing intensive and distributed comprehensive aphasia therapy. Specifically, the results of 1 treatment, verb network strengthening treatment (VNeST), are examined. Method Eight participants were recruited for each of 7 consecutive cohorts for a total of 56 participants. Participants completed 60 hr of aphasia therapy, including 15 hr of VNeST. Two experienced speech-language pathologists delivered the treatment. To promote treatment fidelity, the study team developed a detailed manual of procedures and fidelity checklists, completed role plays to standardize treatment administration, and video-recorded all treatment sessions for review. To assess protocol adherence during treatment delivery, trained research assistants not involved in the treatment reviewed video recordings of a subset of randomly selected VNeST treatment sessions and completed the fidelity checklists. This process was completed for 32 participants representing 2 early cohorts and 2 later cohorts, which allowed for measurement of protocol adherence over time. Percent accuracy of protocol adherence was calculated across clinicians, cohorts, and study condition (intensive vs. distributed therapy). Results The fidelity procedures were sufficient to promote and verify a high level of adherence to the treatment protocol across clinicians, cohorts, and study condition. Conclusion Treatment fidelity strategies and monitoring are feasible when incorporated into the study design. Treatment fidelity monitoring should be completed at regular intervals during the course of a study to ensure that high levels of protocol adherence are maintained over time and across conditions.

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Phonomotor Versus Semantic Feature Analysis Treatment for Anomia in 58 Persons With Aphasia: A Randomized Controlled Trial

Journal of Speech Language and Hearing Research ◽

10.1044/2019_jslhr-l-18-0257 ◽

2019 ◽

Vol 62 (12) ◽

pp. 4464-4482 ◽

Cited By ~ 9

Author(s):

Diane L. Kendall ◽

Megan Oelke Moldestad ◽

Wesley Allen ◽

Janaki Torrence ◽

Stephen E. Nadeau

Keyword(s):

Randomized Controlled Trial ◽

Response Latency ◽

Controlled Trial ◽

Semantic Knowledge ◽

Semantic Feature ◽

Feature Analysis ◽

Group Differences ◽

Randomized Controlled ◽

Confrontation Naming ◽

Semantic Feature Analysis

Purpose The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session, as well as generalization to untrained exemplars and contexts. The purpose of this study was to test the efficacy of phonomotor treatment, a treatment focusing on enhancement of phonological sequence knowledge, against semantic feature analysis (SFA), a lexical-semantic therapy that focuses on enhancement of semantic knowledge and is well known and commonly used to treat anomia in aphasia. Method In a between-groups randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56–60 hr of intensively delivered treatment over 6 weeks with testing pretreatment, posttreatment, and 3 months posttreatment termination. Results There was no significant between-groups difference on the primary outcome measure (untrained nouns phonologically and semantically unrelated to each treatment) at 3 months posttreatment. Significant within-group immediately posttreatment acquisition effects for confrontation naming and response latency were observed for both groups. Treatment-specific generalization effects for confrontation naming were observed for both groups immediately and 3 months posttreatment; a significant decrease in response latency was observed at both time points for the SFA group only. Finally, significant within-group differences on the Comprehensive Aphasia Test–Disability Questionnaire ( Swinburn, Porter, & Howard, 2004 ) were observed both immediately and 3 months posttreatment for the SFA group, and significant within-group differences on the Functional Outcome Questionnaire ( Glueckauf et al., 2003 ) were found for both treatment groups 3 months posttreatment. Discussion Our results are consistent with those of prior studies that have shown that SFA treatment and phonomotor treatment generalize to untrained words that share features (semantic or phonological sequence, respectively) with the training set. However, they show that there is no significant generalization to untrained words that do not share semantic features or phonological sequence features.

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