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Performance, Detection, Contamination, Compliance, and Cointervention Biases in Rehabilitation Research: What Are They and How Can They Affect the Results of Randomized Controlled Trials? Basic Information for Junior Researchers and Clinicians

Armijo-Olivo S, Mohamad N, Sobral de Oliveira-Souza AI, de Castro-Carletti EM, Ballenberger N, Fuentes J

Am J Phys Med Rehabil, 2022 Sep 01;101(9):864-878.
PMID: 35978455 DOI: 10.1097/PHM.0000000000001893

Bias is a systematic error that can cause distorted results leading to incorrect conclusions. Intervention bias (i.e., contamination bias, cointervention bias, compliance bias, and performance bias) and detection bias are the most common biases in rehabilitation research. A better understanding of these biases is essential at all stages of research to enhance the quality of evidence in rehabilitation trials. Therefore, this narrative review aims to provide insights to the readers, clinicians, and researchers about contamination, cointervention, compliance, performance, and detection biases and ways of recognizing and mitigating them. The literature selected for this review was obtained mainly by compiling the information from several reviews looking at biases in rehabilitation. In addition, separate searches by biases and looking at reference lists of selected studies as well as using Scopus forward citation for relevant references were used.This review provides several strategies to guard against the impact of bias on study results. Clinicians, researchers, and other stakeholders are encouraged to apply these recommendations when designing and conducting rehabilitation trials.
Effectiveness of electrotherapy for the treatment of orofacial pain: A systematic review and meta-analysis

de Castro-Carletti EM, Müggenborg F, Dennett L, Sobral de Oliveira-Souza AI, Mohamad N, Pertille A, et al.

Clin Rehabil, 2023 Jul;37(7):891-926.
PMID: 36594219 DOI: 10.1177/02692155221149350

OBJECTIVE: Summarize the evidence from randomized controlled trials and controlled trials that examined the effectiveness of electrotherapy in the treatment of patients with orofacial pain.
DATA SOURCE: Medline, Embase, CINAHL PLUS with Full text, Cochrane Library Trials, Web of Science, and Scopus.
REVIEW METHODS: A data search (last update, July 1, 2022) and a manual search were performed (October 5, 2022). Trials involving adults with orofacial pain receiving electrotherapy compared with any other type of treatment were included. The main outcome was pain intensity; secondary outcomes were mouth opening and tenderness. The reporting was based on the new PRISMA Guidelines.
RESULTS: From the electronics databases and manual search 43 studies were included. Although this study was open to including any type of orofacial pain, only studies that investigated temporomandibular disorders were found. The overall quality of the evidence for pain intensity was very low. Although the results should be carefully used, transcutaneous electric nerve stimulation therapy showed to be clinically superior to placebo for reducing pain after treatment (2.63 [-0.48; 5.74]) and at follow-up (0.96 [-0.02; 1.95]) and reduce tenderness after treatment (1.99 [-0.33; 4.32]) and at follow-up (2.43 [-0.24; 5.10]) in subjects with mixed temporomandibular disorders.
CONCLUSION: The results of this systematic review support the use of transcutaneous electric nerve stimulation therapy for patients with mixed temporomandibular disorders to improve pain intensity, and tenderness demonstrating that transcutaneous electric nerve stimulation is superior to placebo. There is inconsistent evidence supporting the superiority of transcutaneous electric nerve stimulation against other therapies.
Understanding Clinical Significance in Rehabilitation: A Primer for Researchers and Clinicians

Armijo-Olivo S, de Castro-Carletti EM, Calixtre LB, de Oliveira-Souza AIS, Mohamad N, Fuentes J

Am J Phys Med Rehabil, 2022 Jan 01;101(1):64-77.
PMID: 34091470 DOI: 10.1097/PHM.0000000000001799

The objective of this review was to summarize the concept of clinical significance and associated methods focusing on the area of rehabilitation to provide a resource to rehabilitation researchers and clinicians. Studies were searched on electronic databases from inception until July 28, 2020, with no date or language limits. Manual searches as well as Scopus forward citation for relevant references were performed. Narrative synthesis of study results was performed. Definitions of the concepts related to clinical significance, ways of calculating, and interpreting each method were provided using rehabilitation examples. An explanation of methods to evaluate clinical significance (distribution, anchor, and opinion-based methods) and their advantages and disadvantages were also provided. Considering the limitations of statistical significance in assuring meaningfulness of results, clinical interpretation of research outcomes and the report of clinical significance in intervention trials should be a priority in rehabilitation research. When possible, the use of multiple methods (distribution, anchor, and opinion based) is recommended. Thus, clinical researchers are encouraged to present results in a manner that allow the rehabilitation professionals to easily interpret and implement those results in their clinical practice.
The effectiveness of different types of acupuncture to reduce symptoms and disability for patients with orofacial pain. A systematic review and meta-analysis

Mohamad N, de Oliveira-Souza AIS, de Castro-Carletti EM, Müggenborg F, Dennett L, McNeely ML, et al.

Disabil Rehabil, 2024 Feb 15.
PMID: 38357796 DOI: 10.1080/09638288.2024.2310766

PURPOSE: To determine the effectiveness of different types of acupuncture in reducing pain, improving maximum mouth opening and jaw functions in adults with orofacial pain.
METHODS: Six databases were searched until 15 June 2023. The Cochrane risk of bias tool and GRADE were employed to evaluate bias and overall evidence certainty.
RESULTS: Among 52 studies, 86.5% (n = 45) exhibited high risk of bias. Common acupoints, including Hegu LI 4, Jiache ST 6, and Xiaguan ST 7, were used primarily for patients with temporomandibular disorder [TMDs]. Meta-analyses indicated that acupuncture significantly reduced pain intensity in individuals with myogenous TMD (MD = 26.02 mm, I2=89%, p = 0.05), reduced tenderness in the medial pterygoid muscle (standardised mean differences [SMD] = 1.72, I2 = 0%, p
Intention-to-Treat Analysis in Clinical Research: Basic Concepts for Clinicians

Armijo-Olivo S, Barbosa-Silva J, de Castro-Carletti EM, de Oliveira-Souza AIS, Pelai EB, Mohamad N, et al.

Am J Phys Med Rehabil, 2024 Sep 01;103(9):845-857.
PMID: 38320245 DOI: 10.1097/PHM.0000000000002444

This review presents a comprehensive summary and critical evaluation of intention-to-treat analysis, with a particular focus on its application to randomized controlled trials within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. In addition, we included studies from manual searches that were already cataloged within the first author's personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of intention to treat, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for intention to treat, which can lead to misinterpretations and inappropriate application when analyzing randomized controlled trial results, potentially resulting in misleading findings with significant implications for healthcare decision making. Authors should clearly report the specific intention-to-treat definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials for randomized controlled trials, is essential to standardize intention-to-treat information, ensuring the delivery of accurate and informative results for healthcare decision making.