Objective: This study compares post-operative hearing outcomes and morbidity after pediatric total ossicular replacement prosthesis (TORP) ossiculoplasty with transcanal totally endoscopic ear surgery (TEES) versus a post-auricular microscope-guided (PAM) approach. Patients: Forty-four children who underwent ossiculoplasty with titanium TORP after previous cholesteatoma surgery Intervention: Ossiculoplasty using TEES or PAM approach. Main outcome measures: Hearing outcome after ossiculoplasty was determined by post-operative air-bone gap (ABG) on audiogram nearest to 1 year after surgery. Post-operative morbidity was measured by total number of opiate doses the child received during hospital stay, along with the highest documented post-operative pain score. Comparisons were made with Mann-Whitney U test. Results: Hearing data were available for 41 patients: 21 had undergone TEES (median preoperative ABG 39 dB) and 20 had PAM surgery (median preoperative ABG 39 dB). Postoperatively at 1 year, ABG closed significantly in each group (TEES 21 dB, p ¼ 0.003; PAM 23 dB, p ¼ 0.01), and there was no difference between groups ( p ¼ 0.6). 57% who underwent TEES and 50% who underwent PAM surgery experienced serviceable hearing post-operatively, defined as air conduction pure-tone average (PTA) 30 dB HL. Visual analogue pain scores from 0 (no pain) to 10 (worst pain imaginable) were available for 13 who underwent TEES and 18 who underwent PAM surgery. In children undergoing TEES, only two reported pain above 0, with the highest pain score being 4. Children undergoing PAM surgery had a median pain score of 3 (median difference ¼ 3, p < 0.001). Children undergoing TEES required fewer weight appropriate doses of opiate analgesic (median ¼ 0) than children who u n d e r w e n t P A M s u r g e r y ( m e d i a n ¼ 1 ) ( m e d i a n difference ¼ 1, p ¼ 0.003). Children undergoing TEES had a significantly shorter surgical time (median 135 min) than those who underwent PAM surgery (median 168 min) (median difference ¼ 33 min, p ¼ <0.006). Conclusion: Hearing outcomes in TORP ossiculoplasty are similar in TEES and PAM surgery, and TEES may decrease post-operative pain.
Objective: Despite increasing recognition of the importance of functional outcomes for patients with head and neck cancer, post-treatment neck fibrosis remains poorly understood. We sought to develop and validate a patient reported outcome measure for head and neck cancer patients with neck fibrosis.Study Design: Prospective multiphase cross-sectional study. Methods: To guide instrument development, we employed the World Health Organization International Classification of Functioning, Disability and Health as our conceptual framework. Items were generated using a composite strategy consisting of patient focus groups, literature review, and expert opinion from a multidisciplinary group. Candidate items were reduced through the item impact method. Preliminary psychometric properties of the finalized instrument were evaluated through measures of internal consistency, test-retest reliability, and construct validity.Results: Four in person focus groups were held with 13 head and neck cancer patients. The process of item generation led to 221 relevant citations and 68 unique items. An additional 17 items were identified from review of existing neck disability questionnaires and expert opinion. A draft instrument with 25 candidate items was generated and reduced to its final 15-item scale using item impact method. Early psychometric testing revealed excellent internal consistency (Cronbach's alpha = 0.95) and test-retest reliability [ICC = 0.95]. Internal consistency at the item level was good (>0.7) for 11/15 individual items. Four separate constructs were evaluated. Three of the four constructs matched our a priori hypotheses.
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