Development and validation of a disease-specific quality of life questionnaire (EQOL) for potentially curable patients with carcinoma of the esophagus.

The objective was to develop, pretest and validate a disease-specific quality of life questionnaire for potentially curable patients with esophageal carcinoma, for use with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in order to assess the quality of life associated with the various treatment modalities available for this disease. Questionnaire development phase Patients were enrolled in three centres. Literature reviews, patients, family members, and health care professionals generated 195 items: symptoms (55); emotions (53); physical functioning (17); activities of daily living (ADL) (48); and leisure/social (22). Thirty-eight patients identified items of importance and assigned importance ratings on a 5-point Likert scale. Impact scores were calculated as frequency times mean item importance. Item impact scores<20/100 were excluded. Pearson's correlation co-efficients compared domains with the Medical Outcomes Study SF-20 (MOS SF-20). Fifteen items remained. Questionnaire validation phase EORTC QLQ-C30, Esophageal Quality of Life Questionnaire (EQOL), MOS SF-36 and a Global Rating of Change Questionnaire were completed at baseline, 1 week after baseline but prior to any treatment, 1 month, 3 months, and 6 months after treatment began. Reliability was assessed using paired samples correlations. Responsiveness was assessed between mean scores of changed and unchanged patients, and a responsiveness index was calculated. The MOS SF-36 was used for criterion validity. Construct validity included four a priori predictions. Sixty-five patients were enrolled in four centres in the validation phase. Paired samples correlations were high for all domains (0.749-0.889) indicating good reliability. Symptom, physical function and social domains were responsive to change at all time intervals (P<0.05). Emotional function was responsive at 1 and 3 months, activities of daily living (ADLs) at 1 and 6 months. Magnitude of change was significant when direction of change was stated. Between better and worse, magnitude of change was significant in all domains except at 6 months in symptoms, emotional and physical domains. The minimal clinically important difference was consistently around 0.5 for all domains. Minimal, moderate and large effect ranges were established. Only 2/16 time intervals had poor correlations with the SF-36, establishing criterion validity. Of the four a priori predictions for construct validity, only the second part of one prediction, in the emotional function domain, was not confirmed. We have developed a 15-item questionnaire (EQOL) which has good reliability, responsiveness and validity and is now in use in studies in Canadian centres with the EORTC QLQ-C30.

Quality-of-life measurement in surgical randomized controlled trials.

Quality-of-life measurement in controlled clinical trials assessing medical treatment has increased drammatically over the past decades. Although the experience with quality-of-life measurement in surgical clinical trials has been more recent, it has demonstrated the important role of these measures in determining the best treatment options as well as in clinical decisions. Two types of instruments are available to measure quality of life: generic instruments, and specific instruments. Both follow a rigorous scientific methodology that includes both a development and a validation phase. In the validation phase, instruments are assessed for their reproducibility, responsiveness, and validity. Ad hoc instruments, on the other hand, follow no such methodology and results can be open to interpretation. This review demonstrates that quality-of-life measurement in surgical clinical trials is both possible and clinically important. More study investigators will consider measuring quality of life using well-validated instruments when designing future surgical randomized controlled trials.

Laparoscopic Heller myotomy improves esophageal emptying and the symptoms of achalasia.

HYPOTHESIS: Laparoscopic Heller esophageal myotomy improves esophageal clearance and symptoms of achalasia in the early and late postoperative periods. DESIGN: We followed up 98 consecutive patients attending a referral center between February 1, 1994, and July 1, 2000, who underwent laparoscopic myotomy. Operative time, complications, and length of stay were recorded. Postoperative outcomes were assessed using Van Trappen symptom scores (1 indicates no symptoms; 2, symptoms occurring less than once a week; 3, symptoms occurring more than once weekly; and 4, persistent symptoms) and scintigraphic esophageal transit studies. RESULTS: Of 98 patients, 91 underwent anterior fundoplication. There were no open conversions and 1 mucosal perforation, which was closed laparoscopically without complications. Mean operative times and postoperative days were 3.2 hours and 4.3 days, respectively, in the first 32 patients and 1.7 hours and 2.3 days, respectively, in the last 32 patients (P<.001). Postoperative complications included pneumothorax (4% of patients), atelectasis (5%), and delayed gastric emptying (1%). Seventy-five percent of patients gained weight after surgery. At longest follow-up, 91% of patients were satisfied with the outcome of the procedure. Mean Van Trappen scores for dysphagia improved from 4.0 in the preoperative period to 1.2 at early and late follow-up (P<.001). Fluid retention at 10 minutes in the upright position was 47% in the preoperative period and improved at early and late follow-up to 21% and 20%, respectively (P<.001). CONCLUSIONS: Laparoscopic Heller myotomy can safely reverse the symptoms of achalasia and improve esophageal transit. These benefits, realized during the early postoperative period, were maintained at longest follow-up.

Surveillance for carbon monoxide poisoning using a national media clipping service.

Using a novel method to review carbon monoxide (CO) exposures in the US, the role of CO detectors in prevention of CO-related deaths was studied. Using a national media clipping service, CO poisonings reported in the US were analyzed. The impact of CO detectors was investigated through nonfatal outcomes attributable to the presence of CO detectors and case fatality rate comparison among cities with and without CO detector ordinances. There were 4,564 CO exposures resulting in 406 (8.9%) fatalities. Of the exposures 2,617 (57.3%) occurred in the home, accounting for 374 (92.1%) deaths. Faulty heating systems constituted 2,540 (55.6%) exposures and 186 (45.8%) deaths, with alternate heating sources responsible for 389 (8.5%) exposures and 104 (25.6%) deaths. Cities with CO detector ordinances showed lower case fatality rates as reported in the media than those cities without ordinances (P <.001). There were 1,008 (24.2%) survivors who attributed their survival to the presence of a CO detector. A media clipping service provided insight into CO poisoning demographics. Despite its limitations, this tool may calibrate the positive impact of CO detectors on the prevention of CO-related deaths.

Thoracoscopic versus laparoscopic modified Heller Myotomy for achalasia: efficacy and safety in 87 patients.

BACKGROUND: The ideal treatment for achalasia permanently eliminates the dysfunctional lower esophageal sphincter, relieving dysphagia and regurgitation; prevents gastroesophageal reflux; and has an acceptable morbidity rate. Controversy exists concerning whether the thoracoscopic Heller Myotomy (THM) or laparoscopic Heller myotomy (LHM) technique is the best approach to a modified Heller myotomy for achalasia. STUDY DESIGN: We performed a retrospective comparison of the patient characteristics, operative results, postoperative symptoms, and the learning curves for the procedures of 24 patients undergoing THM and 63 patients undergoing LHM between 1991 and 1998. RESULTS: Preoperative patient variables in each group revealed similar distributions for age, gender, and prevalence of previous pneumatic dilation. Mean operating room (OR) times were 4.3 hours (range 2.9 to 5.6 hours) for THM and 3.0 hours (range 1.5 to 6.5 hours) for LHM (p = 0.01). Three esophageal perforations occurred in the THM group and two in the LHM group. Conversion to an open procedure took place in five THM operations (21%) and one LHM operation (2%) (p = 0.005). There were no postoperative esophageal leaks. Mean postoperative length of stay (LOS) for THM was 6.1 days (range 1 to 17 days) and for LHM was 4.0 days (range 1 to 12 days) (p = 0.03). Learning-curve analysis of the first 24 LHM patients compared with the most recent 24 revealed greater OR time in the first 24 mean 3.6 hours, (range 2.0 to 6.5 hours) versus mean 2.3 hours, (range 1.5 to 3.7 hours; p = 0.01), and greater LOS mean 5.5 days, (range 3 to 12 days) versus mean 3.1 days, (range 1 to 8 days; p < 0.01). One esophageal perforation occurred in each subgroup. A similar analysis in the first 12 THM patients compared with the most recent 12 revealed no significant improvement in OR times or LOS. Three esophageal perforations occurred in the latter subgroup only. All patients had preoperative daily dysphagia to solids. Followup data for LHM (n = 49) (median 17 months, range 1 to 39 months) and THM (n = 15) (median 42 months, range 1 to 69 months) revealed no or minimal dysphagia in 90% (44 of 49) after LHM and 31% (4 of 13) after THM (p < 0.01). No or minimal heartburn was present in 89% (41 of 46) after LHM and 67% (8 of 12) after THM (p < 0.05). Regurgitation was absent or minimal in 94% (46 of 49) after LHM and 86% (12 of 14) after THM (p = 0.3). CONCLUSIONS: LHM was associated with decreased OR time, decreased rate of conversion to an open procedure, and shorter LOS compared with THM. LHM was superior to THM in relieving dysphagia and preventing heartburn. LHM may be the preferred surgical treatment of achalasia in some patients.

Surgical management of adenocarcinoma of the cardia.

BACKGROUND: The incidence of adenocarcinoma of the cardia is increasing. The surgical management remains controversial. The present study reviews our experience with surgically resected adenocarcinoma of the cardia. METHODS: A retrospective review of 153 cases of surgically resected adenocarcinoma of the cardia was performed. Preoperative radiotherapy was used in 31 patients. The surgical approach, morbidity, mortality, impact of preoperative radiotherapy, and survival were determined. RESULTS: The type of resection performed was a transhiatal esophagogastrectomy in 78%, a transthoracic esophagogastrectomy in 21%, and a transabdominal esophagogastrectomy in 1%. The in-hospital mortality rate was 4%. The frequency of complications was not associated with the use of preoperative radiotherapy or surgical approach. The 1-year (61%), 2-year (38%), 3-year (23%), and 5-year (16%) survival were not affected by the use of preoperative radiotherapy or surgical approach. Survival was significantly associated with stage and the presence of lymph node metastasis. CONCLUSIONS: Adenocarcinoma of the cardia is associated with a poor long-term prognosis. The long-term survival does not appear to be affected by the use of preoperative radiotherapy or by surgical approach.

Laparoscopic esophageal myotomy and anterior partial fundoplication for the treatment of achalasia.

BACKGROUND: The purpose of this study was to determine the initial results of laparoscopic esophageal myotomy and anterior fundoplication in the treatment of 26 patients with achalasia. METHODS: Operative time, complications, and length of hospitalization were recorded for each patient. Postoperative outcomes were assessed by a standardized patient questionnaire, 24-hour esophageal pH studies, and esophageal transit studies. RESULTS: Twenty-six consecutive patients with class IV dysphagia underwent a laparoscopic esophageal myotomy and anterior partial fundoplication, with a single incidence of intraoperative esophageal perforation. The mean operative time was 3.5 hours. The median length of hospitalization was 5 days. Of the 21 patients for whom follow-up was available (median follow-up, 4 months), 19 (90%) were satisfied and 2 (10%) were somewhat satisfied with their surgery. After operation, 14 of the 21 patients (67%) reported no dysphagia (class I), whereas 6 (28%) had class II dysphagia (less than once per week) and only 1 (5%) had class III dysphagia (greater than once per week). Liquid-phase esophageal transit studies (n = 14) revealed a significant improvement in esophageal clearance in the supine position from 18% before operation to 44% after operation (p = 0.006). Distal esophageal acid exposure was normal in 6 of 7 patients. CONCLUSIONS: These early results suggest that laparoscopic esophageal myotomy and anterior partial fundoplication provides efficacious treatment of achalasia.