Characteristics of the patients. Fig. 1 shows the 133 patients that were randomized. Twenty-one girls were excluded from the analysis: four were non-compliant and lost to follow-up, nine were still treated, and eight refused to start Ox/Pl therapy. The voices of 24 girls were either not recorded or not analyzed due to logistic and/or technical problems. Of the remaining 88 patients, a total of 418 voice recordings were available for the analysis. Table I shows the characteristics of the patients at starting GH and Ox/Pl, which were similar between the three dosage groups. The questionnaire concerning ear, nose & throat history was filled out by 88% (77/88) of the patients. It revealed that 42% (32/77) of the patients had received logopedic therapy prior to their first voice recording and that these patients were evenly distributed over the three dosage groups. Logopedic therapy was started at a mean age of 6.0±1.6 years and was continued for a mean of 1.6±1.1 years, with five patients still following therapy when Ox/Pl was started. The yearly questionnaire regarding recent ear, nose & throat history was filled out before 75% (314/418) of the voice recordings. It revealed that none of the patients had voice complaints due to a concurrent respiratory tract infection. Two patients, one on GH+Ox 0.03 and one on GH+Ox 0.06, confirmed smoking sigarettes (fifteen and four sigarettes per day, respectively). 51 Were excluded 19 Had a bone age > 12 yr 13 Had Y chromosomal material 6 Had used drugs which could negatively influence growth 13 Refused to participate 133 Underwent randomization 184 Patients were assessed for eligibility 30 Were included in the analysis of whom: 3 Reported to be non- compliant 4 Used more estrogens than intended. 8 No voice recordings performed (1 due to MR) or analyzed 4 Refused to start Ox/Pl 4 Have yet to reach adult height 2 Were lost to follow-up 48 Were assigned to receive GH+Pl 27 Were included in the analysis of whom: 1 Reported to be non- compliant 7 Discontinued Ox/Pl prematurely due to 1 Hypertension 1 Difficulty in swallowing the capsule 5 Virilization 1 Used more estrogens than intended 1 Used Lucrin therapy. 9 No voice recordings performed or analyzed 7 No voice recordings performed or analyzed 4 Refused to start Ox/Pl 3 Have yet to reach adult height 2 Have yet to reach adult height 2 Were lost to follow-up 39 Were assigned to receive GH+Ox 0.06 mg/kg/day 46 Were assigned to receive GH+Ox 0.03 mg/kg/day 31 Were included in the analysis of whom: 1 Reported ...
Characteristics of the patients. The clinicopathologic characteristics of the 361 patients in the study cohort are summarized in Table 1. Author Manuscript Interobserver Agreement for Predominant Histologic Subtype and Presence or Absence of Histologic Patterns Using Frozen Sections Among the 3 pathologists, there was substantial agreement on predominant histologic subtype (κ = 0.662): in 64% of cases, all pathologists made the same diagnosis (Table 2). With regard to the presence or absence of histologic patterns, there was also substantial agreement, with a κ value of > 0.6 for four of the 5 histologic patterns (all but acinar pattern). For acinar pattern, although the κ value was only 0.337, all pathologists agreed on a high percentage of cases (82%). Accuracy of Frozen Section for Prediction of Predominant Histologic Subtype and Presence or Absence of Histologic Patterns The accuracy of frozen section for prediction of predominant histologic subtype was 68% (κ Author Manuscript = 0.565 [moderate agreement]; Table 3). With regard to the presence or absence of histologic patterns, the highest accuracy rate was for acinar pattern (89%), followed by solid (84%), lepidic (80%), papillary (72%), and micropapillary (67%). The sensitivity of frozen section for detection of the presence of histologic patterns was highest for acinar pattern (90%), followed by lepidic (75%), papillary (70%), solid (69%), and micropapillary (37%). The specificity of frozen section was highest for solid pattern (96%), followed by micropapillary (94%), lepidic (91%), papillary (79%), and acinar (67%). Author Manuscript Yeh et al. Page 6 Reasons for the Discrepancy between Frozen Section Diagnoses and Permanent Section Diagnoses The reasons for the discrepancy between frozen section diagnoses and permanent section diagnoses of predominant histologic subtype are summarized in Table 4. We found that sampling error, which accounted for 62.7% to 74.1% of errors, was the major reason for discrepancy. Interpretation error was the second most common reason for discrepancy, accounting for 20.2% to 37.3% of errors. Sampling error plus interpretation error was rare, accounting for 10.7% of errors.
Characteristics of the patients. Variable Frequencies Gender: N (%male) 35 (54%) Age: Mean (SD) 56 (12) Duration of complaints in weeks: Median (IQR) 12 (6-29) Medication use: N (%yes) 31 (52%) Pain Score1: Median (IQR) 6 (5-7) SPADI2: Median (IQR) 51 (35-67) SDQ3: Median (IQR) 71 (50-87) EQ5D health status4: Median (IQR) 7 (6-8) Data of the questionnaires of three patients missing. Abbreviations: N, Number; SD, Standard deviation; IQR, Interquartile range. Legend:
