INTENTION TO TREAT ANALYSIS IN CLINICAL RESEARCH: BASIC CONCEPTS FOR CLINICIANS.

ABSTRACT: This review presents a comprehensive summary and critical evaluation of Intention to Treat (ITT) analysis, with a particular focus on its application to randomized controlled trials (RCTs) within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 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. Additionally, 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 ITT, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for ITT, which can lead to misinterpretations and inappropriate application when analyzing RCT results, potentially resulting in misleading findings with significant implications for healthcare decision-making. Authors should clearly report the specific ITT 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 (CONSORT) for RCTs, is essential to standardize ITT information, ensuring the delivery of accurate and informative results for healthcare decision-making.

The effectiveness of different types of acupuncture to reduce symptoms and disability for patients with orofacial pain. A systematic review and meta-analysis.

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 < 0.00001) and jaw dysfunction (SMD = 1.62, I2 = 88%, p = 0.010) in mixed TMD when compared to sham/no treatment. However, the overall certainty of the evidence was very low for all outcomes as evaluated by GRADE. CONCLUSION: The overall results in this review should be interpreted with caution as there was a high risk of bias across the majority of randomized controlled trial (RCTs), and the overall certainty of the evidence was very low. Therefore, future studies with high-quality RCTs are warranted evaluating the use of acupuncture in patients with orofacial pain.

Acupuncture could potentially reduce subjective pain intensity and sensitivity of masticatory muscles, improve mouth opening, and reduce dysfunction in orofacial pain, specifically in patients with temporomandibular disorder (TMD).Acupuncture points such as LI4, ST6, ST7, GB20, SI19, ST36 were the most commonly used acupuncture points to treat patients with orofacial pain, especially TMDs.Clinicians can use the information in this review with caution to develop an effective and appropriate treatment regimen for the acupuncture treatment of patients with TMDs.

Effectiveness of Manual Trigger Point Therapy in Patients with Myofascial Trigger Points in the Orofacial Region-A Systematic Review.

The objective was to compile, synthetize, and evaluate the quality of the evidence from randomized controlled trials (RCTs) regarding the effectiveness of manual trigger point therapy in the orofacial area in patients with or without orofacial pain. This project was registered in PROSPERO and follows the PRISMA guidelines. Searches (20 April 2021) were conducted in six databases for RCTs involving adults with active or latent myofascial trigger points (mTrPs) in the orofacial area. The data were extracted by two independent assessors. Four studies were included. According to the GRADE approach, the overall quality/certainty of the evidence was very low due to the high risk of bias of the studies included. Manual trigger point therapy showed no clear advantage over other conservative treatments. However, it was found to be an equally effective and safe therapy for individuals with myofascial trigger points in the orofacial region and better than control groups. This systematic review revealed a limited number of RCTs conducted with patients with mTrPs in the orofacial area and the methodological limitations of those RCTs. Rigorous, well-designed RCTs are still needed in this field.

Effectiveness of electrotherapy for the treatment of orofacial pain: A systematic review and meta-analysis.

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.

What are the best parameters of low-level laser therapy to reduce pain intensity and improve mandibular function in orofacial pain? A systematic review and meta-analysis.

PURPOSE: To determine the effectiveness of laser therapy for managing patients with orofacial pain (OFP). In addition, to determine which parameters provide the best treatment effects to reduce pain, improve function, and quality of life in adults with OFP. METHODS: Systematic review. Searches were conducted in six databases; no date or language restrictions were applied. Studies involving adults with OFP treated with laser therapy were included. The risk of bias (RoB) was performed with the Revised Cochrane RoB-2. A meta-analysis was structured around the OFP type, and outcomes. Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) assessed the overall certainty of the evidence. RESULTS: Eighty-nine studies were included. Most studies (n = 72, 80.9%) were considered to have a high RoB. The results showed that laser therapy was better than placebo in improving pain, maximal mouth open (MMO), protrusion, and tenderness at the final assessment, but with a low or moderate level of evidence. The best lasers and parameters to reduce pain are diode or gallium-aluminum-arsenide (GaAlAs) lasers, a wavelength of 400-800 or 800-1500 nm, and dosage of <25 J/cm2. CONCLUSIONS: Laser therapy was better than placebo to improve pain, MMO, protrusion, and tenderness. Also, it was better than occlusal splint to improve pain, but not better than TENS and medication.Implications for rehabilitationLaser therapy was found to be good in improving pain, maximal mouth opening, jaw protrusion, and tenderness at the end of the treatment.For patients with all types of temporomandibular disorders (TMDs) (myogenous, arthrogenous, and mixed), the following lasers and parameters are recommended: diode or gallium-aluminum-arsenide (GaAlAs) laser, wavelength of 400-800 or 800-1500 nm, and a dosage <25 J/cm2.For patients with arthrogenous TMDs, the following lasers and parameters are recommended: Diode laser and a wavelength between 400 and 800 nm.For patients with myogenous TMDs, the following lasers and parameters are recommended: diode laser, wavelength between 800 and 1500 nm, and dosage of <25 J/cm2.For patients with mixed TMDs, the following lasers and parameters are recommended: diode, GaAlAs, or infrared laser, a wavelength of 800-1500 nm, a dosage >100 J/cm2, and an application time between 15 and 30 s or >60 seconds.

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.

ABSTRACT: 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.

Selection, Confounding, and Attrition Biases in Randomized Controlled Trials of Rehabilitation Interventions: What Are They and How Can They Affect Randomized Controlled Trials Results? Basic Information for Junior Researchers and Clinicians.

ABSTRACT: A thorough knowledge of biases in intervention studies and how they influence study results is essential for the practice of evidence-based medicine. The objective of this review was to provide a basic knowledge and understanding of the concept of biases and associated influence of these biases on treatment effects, focusing on the area of rehabilitation research. This article provides a description of selection biases, confounding, and attrition biases. In addition, useful recommendations are provided to identify, avoid, or control these biases when designing and conducting rehabilitation trials. 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. If not addressed appropriately, biases related to intervention research are a threat to internal validity and consequently to external validity. By addressing these biases, ensuring appropriate randomization, allocation concealment, appropriate retention techniques to avoid dropouts, appropriate study design and statistical analysis, among others, will generate more accurate treatment effects. Based on their impact on clinical results, a proper understanding of these concepts is central for researchers, rehabilitation clinicians, and other stakeholders working on this field.

Understanding Clinical Significance in Rehabilitation: A Primer for Researchers and Clinicians.

ABSTRACT: 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.