Exercise-Based Dysphagia Treatment: A Proposed Checklist

Abstract

Purpose:

Oropharyngeal swallowing exercise-based interventions are frequently utilized to target physiologic mechanisms with the goal of improving swallowing function. However, study replicability and evidence synthesis regarding effects of interventions are limited due to inconsistent reporting on factors known to influence treatment delivery. In order to promote consistency of reporting factors associated with replicability, the authors constructed a set of preferred parameters focused on dysphagia as part of the initial version of the larger tool (Framework for RigOr aNd Transparency In REseaRch on Swallowing or FRONTIERS).

Method:

Thirty-eight initial questions were assembled by the authors as part of the treatment subsection. Questions were then reviewed by individuals in the FRONTIERS collaborative who have expertise in research, clinical practice, or both.

Result:

Twenty-four questions were removed following review, reducing the final set of treatment-focused questions to 14 questions.

Conclusions:

The revised set of questions provides users of the exercise-based treatment section of the FRONTIERS checklist with an initial checklist to promote transparency and rigor to improve study replicability and evidence synthesis. We intend for this treatment section of FRONTIERS to undergo further refinement following commentary and feedback.

Oropharyngeal dysphagia (or dysphagia) may develop as a result of a variety of etiologies, requiring the use of therapeutic intervention to target swallow physiology with the goal of improving swallowing function and related health and quality-of-life outcomes. The dysphagia treatment literature includes the use of behavioral therapeutic interventions to address bolus flow, safety, and efficiency as well as oropharyngeal muscle strengthening exercises with the aim of modifying swallowing biomechanics. Dysphagia treatment typically incorporates a variety of factors (i.e., treatment factors, patient factors, and clinician factors), which should be clearly outlined to ensure transparent reporting for replication across settings and patient populations. Inconsistent reporting of these factors has been cited as a barrier to evidence synthesis and study replicability (Abell et al., 2015; Hoffmann et al., 2013; Moher et al., 2010).

A number of treatment-specific reporting checklists and recommendations have been developed to improve reporting quality and consistency of treatment outcomes research, including, but not limited to, the Template for Intervention Description and Replication checklist and guide (Hoffman et al., 2014), the Transparent Reporting of Evaluations with Nonrandomized Designs Statement (Des Jarlais et al., 2004), the STrengthening the Reporting of OBservational Studies in Epidemiology statement (Von Elm et al., 2007), the Quality Appraisal Checklist for Case Series Studies (Institute of Health Economics, 2014), and the Methodological Index for Non-Randomized Studies (Slim et al., 2003). Despite the utility of these tools across many disciplines, their use for reporting dysphagia treatment studies may miss important dysphagia-specific methodological aspects.

The goal of this article is to promote rigor and transparency for reporting factors that may impact the design and reporting of exercise-based treatment studies focused on oropharyngeal dysphagia using a critical appraisal tool in the form of a checklist. The items presented here are specifically focused on exercise-based treatment as part of the broader FRONTIERS (Framework for RigOr aNd Transparency In REseaRch on Swallowing) Checklist. We present an initial version of this checklist with the goal of inviting interdisciplinary commentary and feedback that will lead to further refinement of the tool. The focus of this article is on considerations for the design and reporting of dysphagia-specific treatment research; readers should refer to resources such as the EQUATOR network documents (https://www.equator-network.org/) for guidance on optimal clinical trial design and reporting more broadly.

Method

Detailed description of the methods utilized in the creation of the FRONTIERS tool are described in the prologue chapter of this forum (Rogus-Pulia et al., 2024). As a brief description of the methods used for the treatment portion of FRONTIERS, the authors of this subgroup assembled an initial set of 38 questions related to exercise-based treatment following review of current literature addressing dysphagia interventions (see Figure 1). These questions were initially reviewed by members of the steering committee of the FRONTIERS collaborative (four principal investigators of dysphagia-focused labs) and subsequently included in a larger survey of potential questions that were reviewed by the entire FRONTIERS collaborative (consisting of collaborators and trainees across six labs internationally). This group comprised individuals across who have expertise in research, clinical practice, or both, including treatment for swallowing disorders. Questions were rated as “mandatory,” “optional,” “redundant” (e.g., repetitious of a question posed elsewhere in the list), “not needed,” or “reword” (e.g., in the case where the question may not have been clear to the responder). Following the survey, the initial list of treatment-focused questions was reduced to 24 mandatory or required questions. Questions were further iteratively reviewed and revised until consensus was reached with the entire FRONTIERS group. This final set of agreed-upon items were composed of 14 mandatory or required questions.

Figure 1.

Framework for RigOr aNd Transparency In REseaRch on Swallowing treatment checklist development.

Results

The following 14 questions and their subquestions (see Figure 2) were confirmed for the treatment section of the FRONTIERS tool to support critical appraisal of the transparency and rigor of reporting of exercise-based dysphagia treatment interventions. For each question and any relevant subquestions, we provide a rationale for including the question, examples of adequate reporting from studies in the dysphagia or related literature, and an explanation as needed to guide readers through the checklist. A glossary of key terms (see Table 1) is included to provide definition to terms used here.

Figure 2.

Framework for RigOr aNd Transparency In REseaRch on Swallowing (FRONTIERS) framework treatment questions.

Table 1.

Glossary of key terms.

Key term	Definition
Treatment rationale	Purpose for which treatment was recommended
Primary and secondary treatment outcomes	Dependent variables of the treatment
Swallow or swallowing-related treatment target	The physiologic objective that is the focus of the intervention being investigated
Resistance load	Typically a percentage of a maximum value used to determine an appropriate level for treatment
Biofeedback	A method of providing information to the participant regarding a body function that would not normally be known; this method aids the participant in tracking their performance as exercises are completed
Treatment regimen	The treatment plan and its components being used to target physiology and function
Repetitions	The number of times an exercise is completed
Frequency	How often an exercise is completed
Intensity	The percentage of maximum strength, pressure, or flow used for completing a particular exercise or task
Duration	The length of time a participant was engaged in an activity or a session
Total treatment duration	The total length of time that a participant was actively followed as part of intervention
Adherence	The degree to which a participant follows the recommendations of a prescription, intervention, and/or scheduled regimen
Concurrent therapies	Other dysphagia-focused therapies that were prescribed or completed during the intervention period
Home exercise program	A program prescribed by the treatment clinician to the participant to be conducted in the participant's residence

Question 1. Was the Rationale for Providing Treatment Reported?

Rationale: The justification for providing a proposed exercise-based treatment program needs to be clearly stated and contextualized to the reader. A number of guidelines cite the critical importance of having an explicitly stated scientific background, rationale, and purpose for treatment studies (Craig et al., 2013; Downs & Black, 1998; Hoffman et al., 2014; Slim et al., 2003; Von Elm et al., 2007). This question is intended to ensure that users are clearly identifying their rationale for treatment as a key component of transparency.

Example: “Although animal and human studies suggest that exercise may have a beneficial impact on motor function and motor neurons serving the extremities, the role of targeted exercise in ameliorating the effects of motor neuron degeneration in the bulbar and respiratory systems of ALS patients has not been studied systematically. In this study, we assessed the feasibility and impact of expiratory muscle strength training (EMST) on expiratory force-generating ability, swallow kinematics, cough physiology, and airway protection in individuals with ALS” (Plowman et al., 2016, p. 2).

Question 3. Were Secondary Outcomes Identified Prior to Treatment?

Rationale: Outcomes that the authors consider endpoints of either primary interest or secondary interest must be clearly stated as they relate to the treatment program to promote clarity of indicators of treatment efficacy and/or effectiveness. Primary and secondary outcomes should be stated to provide accurate comparison between studies specific to any change that may be measured related to treatment. These may include validated patient-reported outcome measures, physiologic-based measures (e.g., durational measures, rating scales such as the Modified Barium Swallowing Impairment Profile or pixel-based measures such as Analysis of Swallowing Events, Kinematics, and Timing), scales intended to capture changes in safety and/or efficiency of swallowing (e.g., Dynamic Imaging Grade of Swallowing Toxicity, Visual Analysis of Swallowing Efficiency and Safety), or scales that capture functional changes in oral intake or health-related outcomes (e.g., Functional Oral Intake Scale [FOIS], International Dysphagia Diet Standardisation Initiative-Functional Diet Scale, Medical Outcomes of Dysphagia; Crary et al., 2005; Curtis et al., 2022; Hutcheson et al., 2017; Martin-Harris et al., 2008; Martino et al., 2009; Steele et al., 2018). Descriptions of outcome measures used to characterize change prior to and following treatment are highlighted by other intervention-focused frameworks (Craig et al., 2013; Des Jarlais et al., 2004; Hoffman et al., 2014; Von Elm et al., 2007).

Example: “The goals of the current study are to examine the impact of TSE in RAD on the evolution of:

• Strength (expressed as MIP and Pswal).

• Swallowing function (measured by the Mann Assessment of Swallowing Ability—Cancer [MASA-C], Functional Oral Intake Scale [FOIS], and a self-evaluation)

• QoL (measured by the Swallowing Quality of Life Questionnaire [SwalQoL] and the Dysphagia Handicap Index [DHI])” (Van den Steen et al., 2020, p. 2300).

  Note: TSE = tongue strengthening exercises; RAD = radiation associated dysphagia; MIP = Maximum Isometric Pressure; Pswal = Tongue strength during swallowing

Question 4. Were Characteristics of Swallowing Physiology for the Participant Group(s) Described?

Rationale: The reporting of baseline swallowing function may be associated with outcomes of interest, and the chosen treatment should ideally be targeted toward these swallowing impairments. Their addition provides context for the interpretation of study results.

Example: “All patients were randomized to either traditional swallowing therapy as described below or the Shaker exercise. Seven institutions participated in the trial: Northwestern University, Evanston Northwestern Healthcare, Froedtert Hospital, St. Joseph's Hospital of Atlanta, St. Joseph Regional Medical Center, Walter Reed Army Medical Center, and H. Lee Moffitt Cancer Center. Data management and randomization were done by the Communication Sciences and Disorders Research Group within the American Speech Language and Hearing Association in Rockville, Maryland. The inclusion criteria were as follows and were all required: 1. Patients with pharyngeal phase dysphagia (as defined in points 2–4 below) of at least 3 months' duration due to stroke or chemoradiation for head and neck cancer (without surgical intervention to the strap muscles, including the mylohyoid, geniohyoid, anterior digastric, and thyrohyoid muscles). All head and neck cancer patients had chemoradiation and some had secondary surgical intervention after chemoradiation. Patients with head and neck cancer had to be at least 3 months post chemoradiation therapy and at 1 month postsurgery before study entry. 2. Incomplete UES opening and postdeglutitive aspiration, or incomplete UES opening with pre- and postdeglutitive aspiration, as defined on videofluorography (VFG). 3. Hypopharyngeal (pyriform sinus) residue or vallecular residue alone or in combination. 4. Videofluorographically documented aspiration of at least a 3-month duration. 5. Able to comply with protocol mandates, willing to perform the exercise programs, and ability to attend study sessions” (Logemann et al., 2009, p. 2).

Explanation: It is important to understand whether a specific swallow impairment being targeted with the chosen treatment is improving as a result of the treatment. Therefore, it is important to specify the pathophysiology being addressed through the chosen treatment paradigm. This clarifies the “why” aspect of the rationale for which treatment is being provided (Langmore & Pisegna, 2015).

Question 5. Were Swallow or Swallowing-Related Treatment Targets for the Participant Group(s) Described?

Rationale: The rationale for providing the specific treatment as well as the expected mechanisms of action (e.g., strength, endurance, skill, range of motion) should be described. Specificity in the selection of swallowing or swallowing-related treatment targets is important for subsequent measurement of treatment results. This description should include the physiologic goals for treatment, if appropriate, as highlighted by Langmore and Pisegna (2015). This is consistent with other guidelines that indicate that identification and description of the intended target is critical for accurate measurement of posttreatment change (Craig et al., 2008; Hoffman et al., 2014; Von Elm et al., 2007).

Example: “The swallowing exercises (Online resource 1) included range of motion drills to maintain and improve the range of motion of relevant structures and muscle groups [23–25], and resistance exercises to strengthen the same muscles, to overcome increased resistance in the tissue and maintain or improve range of motion (jaw, base of tongue, pharyngeal constrictors, laryngeal elevators and adductors including supra-hyoid muscles” (Mortensen et al., 2015, p. 306).

Question 6. Was a Device/Tool Utilized to Facilitate Treatment?

If yes:

Question 6.1. Was the specific type of device reported (make, model)?

Question 6.2. Was the resistance load setting on the device described (as appropriate)?

If yes:

Question 6.2.1. Were the methods for determining resistance load described (i.e., average, maximum values, or duration across a specified number of trials)?

Question 6.3. Was biofeedback offered as part of treatment?

If yes:

Question 6.3.1. Was the type of biofeedback reported?

Rationale: Descriptions of device specifications and components (hardware/software, make/model, version, year, operating system, peripherals, device calibration) allow for transparency, reproducibility of methodology, and precision for comparative analyses across research studies. Several frameworks and guidelines highlight the importance of describing all physical and informational components used as part of the studied intervention as this can influence on the reproducibility of results observed (Hoffman et al., 2014; Van Stan et al., 2019).

Example 1: “The sEMG activity was measured from electrodes secured over the patient's submental muscles (collectively the mylohyoid, geniohyoid, anterior belly of digastric, and genioglossus). The sEMG data were rectified, low-pass filtered at 50 Hz, sampled at 10 Hz, digitized, and sent to the computer via a Universal Serial Bus port. The BiSSkiT software then processed the data from the sEMG device and plotted it in real time as time by amplitude waveforms that were then displayed on the computer monitor. At the start of each therapy session patients performed 5 hard/effortful swallows to calibrate targeted amplitude range during swallowing. The goal of skill training was to improve the precision of swallowing muscle contraction by developing conscious control over timing and strength of swallowing. This intensive protocol involved increasing levels of difficulty and required proficiency at a particular level before moving to the next level. The practice targets were task-specific, and immediate feedback was provided. The swallowing target was a green square, which moved randomly within the amplitude and temporal range of the computer monitor. The initial size of the square was calculated by taking 50% of the average amplitude of 5 effortful swallows with its height to width ratio fixed at 1:1 (Figure 2). Subsequent size varied according to a patient's performance. Instructions were to “swallow so that the peak of the waveform falls within the square” (also referred to as a hit). This task required precision of swallowing movements to meet the amplitude and temporal aspects of the target. After 3 consecutive successful hits, the size of the target/square reduced by 10%; thus requiring greater amplitude and temporal precision of swallowing. Conversely, after 3 consecutive misses, the square size increased by 10%” (Athukorala et al., 2014).

Explanation: The example indicates a specific type of device utilized for treatment in addition to hardware and software components for setup, which are key for study replication.

Question 7. Were Therapy Sessions Conducted in Groups?

If yes:

Question 7.1. Was the number of participants per group described?

Question 7.2. Was the ratio of clinicians and/or aides to participants reported?

Rationale: Comprehensive descriptions of the composition of the therapy groups allows for reproducibility of the treatment program. To our knowledge, no studies exist to date that describe a group approach to exercise-based dysphagia treatment; therefore, future studies evaluating the efficacy of treatment groups should characterize the number of participants and/or the ratio of clinicians or aides. This question pertains to the setting in which the participant may have received treatment, particularly the unit to which treatment would have been applied (Des Jarlais et al., 2004).

Example: “Of study patients in the participant group, the minimum number of group meetings attended was 2, the maximum number attended was 17, and the mean number attended was 6. The support group meetings included patients with head and neck cancer, a head and neck nurse, a dietitian, a speech pathologist, and a social worker” (Vakharia et al., 2007, p. 407).

Explanation: The example included here comes from the head and neck cancer literature and describes the composition of support groups for patients, including clinical providers participating in the groups.

Question 8. Did the Study Report Any of the Following Items Related to Treatment Regimen? Repetitions, Frequency, Intensity, Duration

Rationale: Dose administration parameters that relate to the treatment regimen should be clearly outlined to fully describe the program. A scoping review performed to characterize the state of current literature on parameters pertaining to dose administration found that there was inconsistent reporting of dose prescription despite recommendations from the American College of Sports Medicine (Krekeler et al., 2020). These are also described in several frameworks as critical ingredients necessary for accurate translation and application in a clinical environment (Des Jarlais et al., 2004; Van Stan et al., 2019).

Example 1: “Participants in the exercise group were instructed on a set of active exercises, completed twice daily, 7 days per week during chemoradiation (CRT) (exception CRT break week in week 4) and up to 3 months post-CRT. The set of exercises included oro-motor strength/stretch exercises and swallow maneuvers. Also, each day participants completed the TheraBite® exercise according to the 7-7-7 protocol (7 passive range of motion stretches, performed 7 times, repeated 7 times each day)” (Messing et al., 2017, p. 409).

Example 2: “The therapy protocol was based on the principles of motor learning, derived from earlier research. Subjects performed 3 therapy sessions per week (totaling 24 sessions) on nonconsecutive days to allow for sufficient rest periods. Each therapy session consisted of 120 tongue presses: 60 anterior repetitions and 60 posterior repetitions. These 60 repetitions were divided into 12 sets of 5 repetitions with obligatory rest periods of 60 seconds between sets. Therapy sessions started in alternating order with either anterior or posterior repetitions. In accordance with the principle of progressive overload, the level of resistance was determined based on 1-repetition maximum (RM) at baseline and subsequently every 2 weeks during training. All subjects trained at 80% 1-RM” (Van den Steen et al., 2020, p. 2300).

Question 9. Was Participant Adherence to the Clinician Schedule and/or Treatment Plan Reported?

Rationale: To ensure that the correct dose of treatment is delivered toward the desired goal related to therapy, data specific to intervention adherence are important to capture. As described by Krekeler and colleagues, “Poor adherence to clinical recommendations may render evidence-based interventions ineffective, ultimately causing immense financial burden on the health-care system as a whole” (Krekeler et al., 2018). It is additionally important to capture whether adherence is reported subjectively (i.e., as reported by patients and/or caregivers) or objectively (i.e., as captured by an external device utilized by treatment), as patient-reported adherence is subject to inaccurate reporting (either underreporting or overreporting).

If yes:

Question 9.1. Was the method of recording and tracking patient adherence to the clinician schedule and/or treatment plan reported (i.e., device recorded vs. patient reported)?

Example 1: “Therapy adherence was first examined across the cohort (n = 71) and then subsequently by group. Adherence was reported descriptively in two ways: percent exercise completed, determined as the total number of exercise cycles completed in relation to total number of cycles in the Pharyngocise protocol (240 cycles); and the proportion of participants completing defined levels of practice (4 levels) including negligible practice (<25% exercise completed), low practice (25–50%), moderate practice (50–75%) or high practice (≥75%)” (Wall et al., 2017, p. 285).

Example 2: “The software installed on these devices recorded lingual press repetition and pressure data. These data included number of repetitions completed, accuracy with which therapeutic targets were met (based on the established maximum isometric lingual pressure, or MIP, threshold), and the date exercises were completed. These data were stored in a section of the program accessible only by clinicians, ensuring that participants were not able to view or tamper with recorded session data” (Krekeler et al., 2021, p. 3).

Question 10. Were the Instructions That Were Provided to the Participant(s) for Completing the Treatment Described?

Rationale: Similar to the description of any device or tool utilized to facilitate therapy, a full description of any informational materials or instructions provided to the participants during the study should be included. The quality and clarity of instructions and materials provided to participants may present as a variable that could impact intervention effects.

Example 1: “Patients were instructed to keep a log of their daily performance to further encourage adherence to the swallowing exercise protocol and to provide a record of individuals who were unable to complete them. Each patient was given written instructions on how to perform the individual swallowing exercises (Figure 1)” (Kotz et al., 2012, p. 377).

Explanation: Informational materials or instructions should be reported and may be included in tables alongside the text, as in the work of Kotz et al. (2012) or as supplemental materials. Incorporating these details can further support replication by other investigators.

Question 11. Did Participants Receive Additional/Concurrent Therapies During the Course of Treatment in Addition to the Treatment Being Studied?

If yes:

Question 11.1. Were the additional/concurrent therapies described?

Rationale: It is important to identify any influence other treatment programs may have on the specific physiology that prescribed interventions are aiming to address (Van Stan et al., 2019).

Example: “The control group received no direct SLP contact during treatment and did not complete any study exercise sets. However, all participants received a TheraBite® prophylactically as per minimum standard of care set at the institution where the study was conducted. Following initial instruction on how to use the device, actual ongoing use of the device during and post-CRT was not monitored. No other prophylactic therapy was provided. If a participant in the control group was subsequently identified as having swallowing problems post-CRT by their medical care team (n = 4), they were provided with swallow therapy exercises as indicated. All were analyzed in the control group” (Messing et al., 2017, p. 491).

Question 12. Was There a Home Exercise Component Prescribed as Part of Treatment?

If yes:

Question 12.1. Was participant adherence to their home program measured/reported?

Rationale: Similar to the rationale for reporting adherence to a clinician schedule or treatment plan, accuracy in reporting patients' completion of their home exercise program is necessary to understand the full dose administered (Krekeler et al., 2020). Furthermore, these details can yield valuable information as to the feasibility of conducting exercises in patients' daily environments (Van Stan et al., 2019).

Example 1: “In addition, caregivers and patients were provided with a binder including daily logs with step-by-step instructions and exercise log sheets. To encourage accurate completion of the home sessions, the following procedures were followed: the patients and the caregivers were instructed to complete the logs together (therefore both would be accountable); at the beginning of the in-clinic sessions, the clinician asked the patients and caregivers to review their log and the exercises/tasks performed during the previous days and made corrections/adjustments to the logs if needed; and at random times (once per week), the clinicians contacted the patients and caregivers (via telephone or e-mail) to ask questions and check whether the protocol was completed as prescribed for that particular day” (Malandraki et al., 2016, p. 570).

Example 2: “Adherence was self-reported at each clinic visit. Participants were prescribed a 5-5-5 training schedule for 8 weeks, totaling 1,000 breaths through the trainer (25 breaths per day, 125 breaths per week)” (Hutcheson et al., 2018, p. 1045).

Question 13. Were the Number Of Clinicians Administering the Treatment Reported?

Rationale: The number of clinicians or study team members providing treatment should be reported as a factor that may influence internal consistency, reliability, and treatment fidelity (Dijkers, 2015; Van Stan et al., 2019).

Example: “Four speech language pathologists from Forsyth Rehabilitation Center, located in various settings, were trained and certified in VitalStim therapy between March and June 2003. The experimental group was made up of 11 patients with pharyngeal or oral/pharyngeal dysphagia who were treated by VitalStim certified speech language pathologists between July and December 2003” (Kiger et al., 2006, p. 244).

Question 14. If There Was More Than One Clinician Administering Treatment, Was the Training Protocol Ensure Consistency Reported?

Rationale: Similar to understanding and accurately characterizing treatment dose of applied dysphagia interventions, it is critical that consistency be maintained among any members of the study team who would have provided treatment interventions as it pertains to administration instructions and clinician responses.

Example 1: “A standardized behavioural swallowing intervention, MDTP, combined with NMES. A single dedicated NMES therapist provided all treatment” (Carnaby et al., 2020, p. 503).

Example 2: “Intervention was administered by 2 experienced speech-language pathologists who were blind to the results of patients' baseline assessments and conducted therapy sessions as per the predefined protocol. The only information available to the treating clinicians was a list of clinical indicators of aspiration, previously identified from instrumental baseline examinations, and the starting material and volume of food or liquid to be used during therapy” (Carnaby-Mann & Crary, 2008, p. 281–282).

Discussion

The goal of the treatment section of the FRONTIERS tool is to outline components that should be reported to ensure rigor and transparency in conducting and reporting exercise-based treatment studies for dysphagia research. The guide and the examples listed are extracted from exercise-based treatment studies conducted in the dysphagia literature that have met the criteria for the component under which they are referenced. This tool is crucial in furthering treatment research in dysphagia as it guides readers and authors to the necessary elements that should be addressed to ensure adequate appraisal of treatment studies when exploring larger questions pertaining to treatment effects and efficacy and for replication of these studies in future cohorts.

A few limitations of our tool must be acknowledged. First, FRONTIERS does not currently include any mention of mobile health exercise systems or telehealth treatment modalities, as guidelines continue to emerge for best practices when it comes to these domains. The accuracy of such applications, and the vast variations in data storage and record keeping must be adequately reported should such applications be utilized for the administration of dysphagia treatment. We acknowledge the efforts put forth to develop dysphagia-specific guidelines for clinicians providing virtual treatments or teletherapy (Malandraki et al., 2021; Sevitz et al., 2022). A second limitation is the variety of devices and technologies being developed for dysphagia treatment, which will require device-specific guidelines for reporting. The ongoing refinement and expansion of the FRONTIERS tool will aim to incorporate this information to provide guidance to users of the tool.

One unique challenge faced by our group when selecting components for transparent and rigorous reporting lies in the current lack of consensus on the efficacy of specific treatments or treatment regimens for dysphagia. This debate is often attributed to a lack of standardization in methodology and data reduction/analyses across studies. Additionally, no clear consensus has been reached in the field regarding the dosage of specific dysphagia treatments or treatment programs. This poses a risk to the success of these treatments for different patient populations but also further highlights the importance of including chosen dosage parameters in the reporting of treatment studies. We also fully acknowledge that this initial version of the FRONTIERS tool requires commentary and feedback and will need to undergo a formal interdisciplinary consensus process prior to broad use. However, a tool such as this is necessary for reporting in dysphagia research to facilitate efforts to build evidence for these dysphagia-specific treatments.

Conclusions

This article provides detailed instructions to users of the treatment section of the FRONTIERS critical appraisal tool in the form of a checklist when used for study design and reporting. The treatment section may be combined with other sections of the FRONTIERS tool (e.g., instrumental assessments) when examining or conducting studies that utilize multiple components of the FRONTIERS framework. Further refinement of this treatment section will occur following feedback on this initial version of FRONTIERS.

Data Availability Statement

All data generated or analyzed during this study are included in this published article.

Funding Statement

The article was partially prepared at the William S. Middleton Memorial Veterans Hospital in Madison, WI (GRECC Manuscript 08-2024). Development of Framework for RigOr aNd Transparency In REseaRch on Swallowing and the preparation of this article was not directly supported by funding to any of the authors. The authors acknowledge funding support as follows: Joanne Yee: Department of Veterans Affairs, Office of Rural Health; William S. Middleton Veterans Affairs Hospital, Madison, WI; Advancing Diversity and Equity in Pre-doctoral Trainees Program as part of the University of Washington School of Medicine and Public Health Institute for Clinical and Translational Research through the Wisconsin partnership Program. Sana Smaoui: The George Washington University; Nicole Rogus-Pulia: University of Wisconsin–Madison; William S. Middleton Veteran Affairs Hospital, Madison, WI; and National Institutes of Health grant number K76AG068590. The views and content expressed in this article are solely the responsibility of the authors and do not necessarily reflect the position, policy, or official views of the National Institutes of Health or the Department of Veterans Affairs.