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).

The impact of seasonal operating room closures on wait times for oral cancer surgery.

BACKGROUND: Operating room slowdowns occur at specific intervals in the year as a cost-saving measure. We aim to investigate the impact of these slowdowns on the care of oral cavity cancer patients at a Canadian tertiary care centre. METHODS: A total of 585 oral cavity cancer patients seen between 1999 and 2015 at the London Health Science Centre (lhsc) Head and Neck Multidisciplinary Clinic were included in this study. Operating room hours and patient load from 2006 to 2014 were calculated. Our primary endpoint was the wait time from consultation to definitive surgery. Exposure variables were defined according to wait time intervals occurring during time periods with reduced operating room hours. RESULTS: Overall case volume rose significantly from 2006 to 2014 (p < 0.001), while operating room hours remained stable (p = 0.555). Patient wait times for surgery increased from 16.3 days prior to 2003 to 25.5 days in 2015 (p = 0.008). Significant variability in operating room hours was observed by month, with lowest reported for July and August (p = 0.002). The greater the exposure to these months, the more likely patients were to wait longer than 28 days for surgery (odds ratio per day [or]: 1.07, 95% confidence interval [ci]: 1.05 to 1.10, p < 0.001). Individuals seen in consultation preceding a month with below average operating room hours had a higher risk of disease recurrence and/or death (hazard ratio [hr]: 1.59, 95% ci: 1.10 to 2.30, p = 0.014). CONCLUSIONS: Scheduled reductions in available operating room hours contribute to prolonged wait times and higher disease recurrence. Further work is needed to identify strategies maximizing efficient use of health care resources without negatively affecting patient outcomes.

Functional MRI of oropharyngeal air-pulse stimulation.

Although the posterior oral cavity and oropharynx play a major role in swallowing, their central representation is poorly understood. High-field functional magnetic resonance imaging of the brain was used to study the central processing of brief air-pulses, delivered to the peritonsillar region of the lateral oropharynx, in six healthy adults. Bilateral air-pulse stimulation was associated with the activation of a bilateral network including the primary somatosensory cortex and the thalamus, classic motor areas (primary motor cortex, supplementary motor area, cingulate motor areas), and polymodal areas (including the insula and frontal cortex). These results suggest that oropharyngeal stimulation can activate a bilaterally distributed cortical network that overlaps cortical regions previously implicated in oral and pharyngeal sensorimotor functions such as tongue movement, mastication, and swallowing. The present study also demonstrates the utility of air-pulse stimulation in investigating oropharyngeal sensorimotor processing in functional brain imaging experiments.

Impact of a massive waterborne cryptosporidiosis outbreak on child care facilities in metropolitan Milwaukee, Wisconsin.

OBJECTIVE: We describe the impact of the 1993 waterborne cryptosporidiosis outbreak on metropolitan Milwaukee child care homes and centers. METHODS: Information on outbreak-related illness and changes in policies and practices was collected from directors of 117 facilities. Stool specimens from 129 diapered children from 11 centers were screened for Cryptosporidium. RESULTS: Most (74%) facility directors reported children or staff with diarrhea during the outbreak; however, only 4 (3.4%) facilities closed because of illness among staff or children. During the outbreak child care homes were less likely to exclude children with diarrhea than were child care centers. Among diapered children attending centers the Cryptosporidium prevalence was 30%; 29% of infected children had no history of diarrhea associated with the Milwaukee outbreak. CONCLUSIONS: Facilities continued to operate during the outbreak despite considerable illness among children and staff. The news media were effective means for providing public health information to child care facilities. Although secondary transmission undoubtedly took place in child care facilities, the presence of children with asymptomatic Cryptosporidium infections did not result in an increased risk of diarrhea in infant and toddler rooms.

Complications and results of phacoemulsification performed by residents.

The use of phacoemulsification by ophthalmic surgeons has increased markedly over the past five years. Previous studies have reported relatively high rates of vitreous loss by residents learning phacoemulsification. We retrospectively analyzed the complications and results in 300 cases of phacoemulsification with intraocular lens implantation performed by residents. The first 40 cases done by four residents in their second year of training were compared with approximately the last 40 cases done by each resident at the end of the third year. The overall rate of surgical complications was 6.3%, and the total rate of vitreous loss was 3.3%. The rate of surgical complications during the initial surgeries in the second year of residency was 9.3%; it was 3.3% by the end of the third year. The rate of vitreous loss was 5.3% in the second year and 1.3% during the third year. Postoperatively, 90.6% of all eyes had a final best corrected visual acuity of 20/40 or better (95% excluding patients with pre-existing ocular disease). With proper training and supervision, the rate of surgical complications for residents learning phacoemulsification is acceptably low when compared with the rate of extracapsular cataract extraction.