Beyond efficacy and effectiveness: conducting economic analyses during clinical trials.

Few studies have examined cost issues in the field of dysphagia. This study presents cost data collected during a clinical trial in speech-language pathology, demonstrating the types of cost analyses that can be conducted and highlighting obstacles and issues facing investigators who seek to conduct economic analyses in this arena. Seventy-nine patients were enrolled in the clinical trial to assess the impact of a swallowing intervention on swallowing and speech function. The patients were at least one year past treatment for head and neck cancer. No significant intervention differences were detected in these outcomes. A companion economic analysis was conducted in 37 of these patients using patient diaries and followup with identified health care providers. Analyses indicated that (1) the intervention did not significantly reduce health care expenditures; (2) indirect costs and costs of hospitalizations are both important factors to consider during a trial; and (3) health care costs of this population are high relative to the rest of the U.S. population. Attrition from the overall study population can pose a serious threat to the viability of an economic study. The article concludes with a discussion of how these issues can be addressed in future studies.

Swallow function and perception of dysphagia in patients with head and neck cancer.

BACKGROUND: The relationship between subjective complaints of dysphagia and objective measures of swallow function in patients with cancers of the oral cavity, pharynx, or larynx, treated with radiotherapy +/- chemotherapy has not been well documented in the literature. METHODS: Swallowing function in 132 patients with various lesions was evaluated using videofluoroscopy and analyzed by patient complaint of dysphagia grouping. RESULTS: Patients with complaints of dysphagia demonstrated significantly worse swallow function as indicated by lower oropharyngeal swallow efficiency (OPSE), longer transit times, larger residues, and more swallows with aspiration. Patients with complaints of dysphagia also tended to take less of their nutrition by mouth and less variety of food consistencies in their diet compared with those without complaint. CONCLUSIONS: Patients were able to perceive decrements in their swallowing function as dysphagia and may have limited their oral intake in response to that perception. The ability to accurately perceive swallowing function may be useful for self-monitoring changes in dysphagia status during a course of swallow therapy.

Swallowing and speech ability after treatment for head and neck cancer with targeted intraarterial versus intravenous chemoradiation.

OBJECTIVE: RADPLAT (concurrent selective supradose intraarterial cisplatin and external-beam irradiation) delivers extraordinarily high cisplatin concentration to head and neck structures. This study was designed to quantify and compare RADPLAT and systemic chemoradiation treatment effects on swallowing and speech. METHODS: Videofluorographic swallowing studies and articulation testing of 14 head and neck cancer patients treated with RADPLAT were compared with 16 treated with systemic chemoradiation 1 month after treatment. RESULTS: RADPLAT and systemic chemoradiation patients did not differ significantly on most swallow outcome measures, and there was significantly less aspiration on 1 and 3 mL liquid for RADPLAT individuals. Speech function was comparable except for RADPLAT's significantly worse /s, z/ productions. CONCLUSIONS: Increased concentration of cisplatin to the head and neck did not result in generally reduced swallowing or articulatory function.