The PRO-ACTIVE trial protocol: a randomized study comparing the effectiveness of PROphylACTic swallow InterVEntion for patients receiving radiotherapy for head and neck cancer.

BACKGROUND: Swallowing therapy is commonly provided as a treatment to lessen the risk or severity of dysphagia secondary to radiotherapy (RT) for head and neck cancer (HNC); however, best practice is not yet established. This trial will compare the effectiveness of prophylactic (high and low intensity) versus reactive interventions for swallowing in patients with HNC undergoing RT. METHODS: This multi-site, international randomized clinical trial (RCT) will include 952 adult patients receiving radiotherapy for HNC and who are at high risk for post-RT dysphagia. Participants will be randomized to receive one of three interventions for swallowing during RT: RE-ACTIVE, started promptly if/when dysphagia is identified; PRO-ACTIVE EAT, low intensity prophylactic intervention started before RT commences; or, PRO-ACTIVE EAT+EXERCISE, high intensity prophylactic intervention also started before RT commences. We hypothesize that the PRO-ACTIVE therapies are more effective than late RE-ACTIVE therapy; and, that the more intensive PRO-ACTIVE (EAT + EXERCISE) is superior to the low intensive PRO-ACTIVE (EAT). The primary endpoint of effectiveness is duration of feeding tube dependency one year post radiation therapy, selected as a pragmatic outcome valued equally by diverse stakeholders (e.g., patients, caregivers and clinicians). Secondary outcomes will include objective measures of swallow physiology and function, pneumonia and weight loss, along with various patient-reported swallowing-related outcomes, such as quality of life, symptom burden, and self-efficacy. DISCUSSION: Dysphagia is a common and potentially life-threatening chronic toxicity of radiotherapy, and a priority issue for HNC survivors. Yet, the optimal timing and intensity of swallowing therapy provided by a speech-language pathologist is not known. With no clearly preferred strategy, current practice is fraught with substantial variation. The pragmatic PRO-ACTIVE trial aims to specifically address the decisional dilemma of when swallowing therapy should begin (i.e., before or after a swallowing problem develops). The critical impact of this dilemma is heightened by the growing number of young HNC patients in healthcare systems that need to allocate resources most effectively. The results of the PRO-ACTIVE trial will address the global uncertainty regarding best practice for dysphagia management in HNC patients receiving radiotherapy. TRIAL REGISTRATION: The protocol is registered with the US Patient Centered Outcomes Research Institute, and the PRO-ACTIVE trial was prospectively registered at ClinicalTrials.gov , under the identifier NCT03455608 ; First posted: Mar 6, 2018; Last verified: Jun 17, 2021. Protocol Version: 1.3 (January 27, 2020).

Enteral tube feeding for amyotrophic lateral sclerosis/motor neuron disease.

BACKGROUND: Enteral feeding (tube feeding) is offered to many people with amyotrophic lateral sclerosis/motor neuron disease experiencing difficulty swallowing (dysphagia) and maintaining adequate nutritional intake leading to weight loss. OBJECTIVES: The aim of this review is to examine the efficacy of percutaneous endoscopic gastrostomy placement or other tube feeding placement on: (1) survival; (2) nutritional status; (3) quality of life. Another aim is to examine the minor and major complications of percutaneous endoscopic gastrostomy. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Group Trials Register (June 2005), MEDLINE (from January 1966 to June 2005), and EMBASE (from January 1980 to June 2005) for randomized controlled trials. In addition we searched MEDLINE (January 1966 to June 2005) and EMBASE (January 1980 to June 2005) to identify non-randomized studies that might be worthy of review and discussion. We checked references in published articles, proceedings of scientific meetings, and enlisted personal communications to identify any additional references. SELECTION CRITERIA: All randomized and quasi-randomized controlled trials were to have been selected. Since no such trials were discovered, all prospective and retrospective controlled studies were reviewed in the 'Background' or 'Discussion' sections of the review. DATA COLLECTION AND ANALYSIS: We independently assessed study methodological design and extracted data. We considered the following outcomes: (1) survival rate in months (of primary interest), (2) nutritional status measured by weight change, change in body mass index, or other quantitative index of nutritional status, and (3) self-perceived quality of life We were also interested in reports of safety of the procedure as indicated by (4) minor and major complications of percutaneous endoscopic gastrostomy or other feeding tube placement. MAIN RESULTS: We found no randomized controlled trials comparing the efficacy of enteral tube feeding with those people who continued to eat orally, without enteral feeding. We summarized the results of retrospective and prospective case controlled studies in the 'Discussion' section of this review. AUTHORS' CONCLUSIONS: There are no randomized controlled trials to indicate whether enteral tube feeding is beneficial compared to continuation of oral feeding for survival. The 'best' evidence to date, based on controlled prospective cohort studies, suggests an advantage for survival in all people with amyotrophic lateral sclerosis/motor neuron disease, but these conclusions are tentative. Evidence for improved nutrition is also incomplete but tentatively favorable. Quality of life has only been addressed by a few researchers and needs more serious attention.

The effects of executive and behavioral dysfunction on the course of ALS.

OBJECTIVE: To determine whether patients with ALS-frontotemporal lobar dementia (FTLD) have a shorter survival and are less compliant with recommended treatments than those with ALS who have normal executive and behavioral function (classic ALS). METHODS: Survival analysis from ALS symptom onset to death included 81 of 100 consecutive patients who could be classified definitely as ALS with abnormal executive or behavioral function or as classic ALS. Criteria were defined for compliance with noninvasive positive-pressure ventilation (NPPV) and percutaneous endoscopic gastrostomy (PEG). RESULTS: Median survival was 2 years 4 months for the 28 patients with FTLD and 3 years 3 months for the 53 patients with classic ALS (relative hazard for death 1.93, CI 1.09 to 3.43; p = 0.024). However, the relative hazard associated with FTLD (1.49) in the multivariate model was diminished by the association of FTLD with bulbar onset and older age and was not significant in this sample size. With bulbar onset, median survival was 2 years 0 months for the 14 with ALS-FTLD and 2 years 10 months for the 10 with classic ALS (relative hazard for death 2.78, CI 1.02 to 7.55; p = 0.045), and older age was not a significant risk. Noncompliance with NPPV and PEG were 75% and 72% in ALS-FTLD, respectively, vs 38% and 31% in classic ALS (relative risks 2.00 and 2.34; p = 0.013 and 0.022). CONCLUSIONS: Survival is significantly shorter among patients with ALS-FTLD than with classic ALS. Furthermore, patients with ALS-FTLD are twice as likely to be noncompliant.

Are amyotrophic lateral sclerosis patients cognitively normal?

BACKGROUND: Patients with ALS are often told that the disease spares cognition; however, recent evidence suggests deficits in frontal executive skills occur in a sizable minority of ALS patients. In many instances, the frontal executive deficits represent the co-occurrence of frontotemporal lobar dementia (FTLD) and ALS. METHODS: Word generation, a simple frontal task that takes <2 minutes, was tested in 100 consecutive patients with ALS seen in the authors' multidisciplinary clinic. Any patient with a prior dementia diagnosis was excluded from the study. A subset of 44 patients agreed to undergo further neuropsychological testing and clinical interview to confirm or deny a diagnosis of dementia. RESULTS: Diminished word generation was found in one-third. Of the patients with abnormal word generation who agreed to further evaluation, nearly all were shown to meet research criteria for FTLD. In addition, one-quarter of the patients with normal word generation who agreed to further evaluation met research criteria for FTLD; these patients had new-onset personality changes. CONCLUSIONS: This study suggests that frontal executive deficits are present in half of ALS patients, many of whom meet strict research criteria for FTLD. Word generation tests are a useful screening tool in this cohort.

Issues in the management of dysphagia.

Management of patients with dysphagia is a necessary part of our clinical intervention. Some areas of management include implementing dietary changes that the patient will accept and training caretakers to feed dependent patients safely and to provide oral care to dependent patients. The tube-fed patient has special needs in regard to quality of life and is at greater risk for pneumonia, requiring the effective skills of multiple disciplines to effectively manage this patient. The most successful dysphagia programs address these management concerns from a multidisciplinary perspective; the speech-language pathologist cannot function effectively as a sole provider.

Predictors of aspiration pneumonia: how important is dysphagia?

Aspiration pneumonia is a major cause of morbidity and mortality among the elderly who are hospitalized or in nursing homes. Multiple risk factors for pneumonia have been identified, but no study has effectively compared the relative risk of factors in several different categories, including dysphagia. In this prospective outcomes study, 189 elderly subjects were recruited from the outpatient clinics, inpatient acute care wards, and the nursing home care center at the VA Medical Center in Ann Arbor, Michigan. They were given a variety of assessments to determine oropharyngeal and esophageal swallowing and feeding status, functional status, medical status, and oral/dental status. The subjects were followed for up to 4 years for an outcome of verified aspiration pneumonia. Bivariate analyses identified several factors as significantly associated with pneumonia. Logistic regression analyses then identified the significant predictors of aspiration pneumonia. The best predictors, in one or more groups of subjects, were dependent for feeding, dependent for oral care, number of decayed teeth, tube feeding, more than one medical diagnosis, number of medications, and smoking. The role that each of the significant predictors might play was described in relation to the pathogenesis of aspiration pneumonia. Dysphagia was concluded to be an important risk for aspiration pneumonia, but generally not sufficient to cause pneumonia unless other risk factors are present as well. A dependency upon others for feeding emerged as the dominant risk factor, with an odds ratio of 19.98 in a logistic regression model that excluded tube-fed patients.

Geriatric oral health and its impact on eating.

OBJECTIVE: Adequate food and fluid intake and nutritional health are requisites for sustaining life. The oral-pharyngeal region has evolved multiple, highly regulated processes to ensure that the intake, chewing, and swallowing of foods and beverages is maintained. The objective of this paper is to identify the independent and collective roles of oral health on eating in older people. DESIGN: Research reports from peer-reviewed scientific journals. Hypothesis-driven research that objectively examined taste, smell, dental and oral mucosal health, dental prostheses, chewing, and swallowing in the context of aging. DATA EXTRACTION AND SYNTHESIS: Data results were extracted independently by multiple observers. A qualitative synthesis of data results from independent studies was made in order to form conclusions regarding the role of oral health on eating in older people. CONCLUSIONS: Many oral functions remain intact in healthy older adults. However, significant alterations arise from oral and systemic diseases and their treatments, and these may have a profound effect on eating, drinking, and the nutritional status of older individuals. The care of older persons with smell, taste, dental/alveolar, oral mucosal, chewing, and swallowing problems requires a multidisciplinary team of health care providers. Recognition of the interrelationship between oral, pharyngeal, and systemic physiological processes will help practitioners identify the etiology of these disorders and implement appropriate therapy.

The significance of accumulated oropharyngeal secretions and swallowing frequency in predicting aspiration.

This study retrospectively investigated the value of both endoscopically visible oropharyngeal secretions in the hypopharynx and swallowing frequency in the prediction of aspiration of food and liquid. Fiberoptic endoscopic evaluation of swallowing (FEES) was performed on a total of 69 individuals that included hospitalized elderly, nonhospitalized elderly, and young normal subjects. A four-level rating scale for determining the severity of accumulated oropharyngeal secretions was developed and employed to rate subjects prior to the presentation of food or liquid during the FEES. Spontaneous dry swallows were also counted during the observation period of the FEES. It was found that the accumulation of endoscopically visible oropharyngeal secretions located within the laryngeal vestibule was highly predictive of aspiration of food or liquid. There were significantly fewer spontaneous swallows in hospitalized subjects when compared with nonhospitalized subjects. There was also a significant decrease in the frequency of spontaneous swallows in aspirating hospitalized subjects when compared with nonaspirating hospitalized subjects. Results are discussed in terms of integrating this information with clinical bedside examination techniques.

Dental findings in geriatric populations with diverse medical backgrounds.

OBJECTIVE: To determine whether there is a difference in the oral/dental health in older persons with different life styles and medical status. STUDY DESIGN: Survey (cross-sectional study) included four groups: (1) subjects (n = 123) living in a residential retirement home or community dwelling; (2) subjects (n = 218) seeking dental treatment at a Veterans Affairs Dental Outpatient Clinic; (3) subjects (n = 132) resident in a VA long-term care facility; and (4) subjects (n = 81) recently admitted to a VA acute care ward with a diagnosis of cerebral vascular accident or other neurologic problem. Each subject answered questions on medical and dental health and dietary preferences in a comprehensive interview. They were given a comprehensive dental examination that included measurements of stimulated salivary flow and minor salivary gland output. RESULTS: The data from groups 2 and 3 confirmed previous reports that independent living subjects have better oral/dental health than dependent living subjects. The data from groups 1 and 4, obtained from geriatric populations on the opposite ends of the medical health/disease continuum provide new information that suggests that good medical health and good oral/dental health are linked. The subjects in group 1 were very healthy as judged by their longevity; 54% were > or = 80 years and they had low reported prevalence of medical disease. Only 6% were edentulous and the dentate persons were missing 4.5 teeth. In contrast, over 50% of the patients in group 4 were < 70 years; they had an edentulous rate of 49% and among the dentate persons had an average 12 missing and 5 decayed teeth. CONCLUSIONS: The medically healthy persons had excellent dental health whereas the sickest persons were either edentulous or had many missing teeth.

Xerostomia, xerogenic medications and food avoidances in selected geriatric groups.

OBJECTIVE: To study the relationship between complaints of xerostomia and salivary performance and food avoidances in four geriatric groups chosen to reflect a broad spectrum of individuals along the health-disease continuum. To determine whether xerogenic medications taken by these individuals could be associated with either complaints of xerostomia or with food avoidances. DESIGN: Cross-sectional survey. Clinical examinations and interview. SETTING: A VA dental clinic and a retirement home. PATIENTS AND OTHER PARTICIPANTS: Subjects were 529 individuals older than 56 years of age, living both in institutions and in the community (average age 70 years). Two hundred eight persons were recruited from a VA Dental Clinic, 114 from a residential retirement home, and 132 from a nursing/long-term-care facility; 75 were from an acute care ward and had a diagnosis of a cerebral vascular accident or other neurological condition. OUTCOME MEASURES: Prevalence of xerostomia, dental morbidity, salivary flow, and food avoidances. RESULTS: About 72% of the subjects experienced xerostomia sometime during the day. Stimulated salivary flow was found to be significantly lower in individuals who complained of xerostomia than in those who did not. Fifty-five percent of participants reported using one or more xerogenic medications, with an 86% prevalence in the nursing/long-term-care facility. Individuals with xerostomia had difficulty in chewing and in starting a swallow and were significantly more likely to avoid crunchy foods such as vegetables, dry foods such as bread, and sticky foods such as peanut butter in their diets. Specific medications such as the inhalants ipratropium and triamcinolone and the systemic agents oxybutynin and triazolam could be statistically associated with xerostomia and/or low salivary flow, and/or specific food avoidances. CONCLUSION: Xerostomia apparently affects the ability to chew and start a swallow. This leads to avoidance of certain foods, which raises the possibility that xerostomia could contribute to undernutrition in older persons. The topically applied ipratropium and triamcinolone and the systemic agents amitriptyline, oxybutynin and triazolam could be statistically associated with one or more complaints of xerostomia.

Efficacy of behavioral treatment for oropharyngeal dysphagia.

In this critique of research in behavioral treatment of dysphagia, three types of investigations are briefly reviewed: general management guides, specific behavioral treatments applied to single patients or a few patients, and dysphagia programs applied to large numbers of patients. Efficacy of treatment has been demonstrated in some of the single-case or small-group studies where specific techniques have been utilized. Unfortunately, efficacy has not been demonstrated in any of the studies where large groups of patients have been enrolled in dysphagia programs. Some of the critical factors that have been lacking in many of these studies are discussed and the need to include functional outcome measures in efficacy studies is emphasized.

Treatment efficacy for adults with oropharyngeal dysphagia.

Over the last 10 years, the literature in the area of oropharyngeal dysphagia has focused on treatment techniques for specific medical conditions and the documentation of treatment efficacy. Increasingly, there has been multidisciplinary involvement in the study of swallowing physiology and dysphagia. Investigators have used a wide range of technologies in quantifying changes in swallowing physiology as a result of imposed therapeutic adjustments and maneuvers. Group studies and single case design investigations have attempted to address the question of treatment efficacy. This article addresses the status of clinical treatment and the future needs for research.

Behavioral treatment for adults with oropharyngeal dysphagia.

Oropharyngeal dysphagia has been treated by various professionals for many years, with increasingly more attention paid to this disorder by speech-language pathologists in the past decade. There has been a gradual change in emphasis in the literature, from early anecdotal accounts to more scientific, controlled studies that have tested the outcomes and effectiveness of certain techniques or programs. This article reviews the literature in the area of behavioral treatment for oropharyngeal dysphagia, with a critical look at the current state of knowledge. General treatment programs and techniques developed to facilitate or compensate for specific swallowing disorders are summarized.

Physiologic deficits in the orofacial system underlying dysarthria in amyotrophic lateral sclerosis.

The purpose of this study was to delineate some of the physiological deficits in the orofacial musculature of patients with dysarthria associated with amyotrophic lateral sclerosis (ALS) and to relate the physiologic deficits to perceived severity of dysarthria. Strain gauge force transducers placed on the lower lip, jaw, and tongue tip were used to measure maximum strength and maximum rate of repeated contractions. Diadochokinetic rates for repeated /pe/ and and /te/ were also determined. Fourteen ALS patients and 15 normal subjects were tested. It was found that the ALS patients with dysarthria were impaired in all tasks compared to the normal subjects, and that some measures revealed impairment even in those ALS patients who were not yet dysarthric. Bulbar ALS patients were generally more severely affected than the corticobulbar or spinal ALS patients, and the tongue was generally the most affected structure in all ALS groups. Perceived severity of dysarthria was more highly correlated with the measures of repeated contraction rate than with the measures of strength, suggesting that more severe dysarthria may be largely due to slower movement of the orofacial structures until substantial muscle strength has been lost.

Indications and techniques of endoscopy in evaluation of cervical dysphagia: comparison with radiographic techniques.

The technique of fiberoptic endoscopic evaluation of swallowing disorders (FEES), and a comparison of its utility with that of videofluoroscopic examination in patients with dysphagia, was presented in a workshop session. Viewpoints were expressed by two speech pathologists and an otolaryngologist experienced in assessment and treatment of patients with dysphagia, and representative cases, illustrated with videotaped FEES and videofluoroscopic studies, were discussed. Some of the major advantages and disadvantages of each of these modalities are discussed in the following three articles.