Patient-centered measures for achalasia.

BACKGROUND: Various instruments may be used to measure health-related quality of life in patients with achalasia. METHODS: We administered four patient-centered measures used for evaluation of achalasia severity [an achalasia severity questionnaire we developed previously, an achalasia symptom checklist, the Gastrointestinal Quality-of-Life Index (GIQLI), and the Medical Outcomes Study 36-item Short-Form survey (SF-36)] to 25 subjects enrolled in a randomized controlled trial comparing pneumatic dilatation and laparoscopic Heller myotomy. We estimated correlations between the different measures. RESULTS: Twenty-five patients (13 male, 12 female) were studied; 12 were treated by pneumatic dilatation and 13 by laparoscopic myotomy. The average age of patients was 48.5 [range 25-69, standard deviation (SD) 13.7] years. Baseline scores demonstrated a substantial burden of impairment. The mean (SD) score on the achalasia severity measure [ranges from 0 (best) to 100 (worst)] was 62.3 (13.4). The mean (SD) symptom checklist score [ranges from 0 (best) to 36 (worst)] was 23.2 (6.6). The mean (SD) GIQLI [ranges from 0 (worst) to 144 (best)] was 77.04 (19.4). The SF-36 mean (SD) for the physical component score (PCS) was 45.29 (9.21) and the mean for the mental component score (MCS) was 37.61 (14.97). The achalasia severity measure correlated highly with the GIQLI (r = -0.57, p = 0.01), and the symptom checklist (r = 0.65, p = 0.004). The achalasia severity measure correlated well with the SF-36 PCS (r = -0.42, p = 0.039), but not with the MCS (r = -0.14, p = 0.501). CONCLUSION: Subjects recruited to a randomized controlled trial of achalasia treatment demonstrated impairment in both generic quality-of-life and disease-specific measures. Scores on achalasia-specific measures correlated well with each other, but less well with measures of generic quality-of-life and mental health scales. Because of the multidimensional nature of achalasia, disease-specific measures should be combined with generic health measures for the best assessment of patient outcome.

Effect of surgeon on outcome of antireflux surgery.

BACKGROUND: We sought to determine whether subjective outcomes one or more years after antireflux surgery are affected by the operating surgeon. METHODS: We reviewed records of patients who had antireflux surgery from June 2000 to June 2002 and mailed the patients a 19-item survey that focused on current medication use, postoperative symptom improvement, and satisfaction with surgery. We tested the significance of predictor variables using chi-squared and Fisher exact tests for categorical variables and analysis of variance for continuous variables. RESULTS: We mailed the survey to 74 patients. Ninety-one percent of the operations were initially laparoscopic, with 5 (7%) subsequently converting to open. Ninety-five percent of patients were taking protein pump inhibitors (PPIs) preoperatively. Surgeons (n = 7) were divided into four groups, with the four surgeons who did two or fewer procedures in one group. Fifty-two of 74 patients (70%) responded to the survey (mean age, [SD] 44 [21] years, 37% male). The mean duration of followup was 2.1 [0.46] years. Thirty-eight percent of patients were taking medications for gastroesophageal reflux disease at the time of survey completion. It was found that the surgeon had an influence on patients' perceptions of the success of the surgery and whether having surgery was a good idea. We did not identify a statistically significant effect of the surgeon on preoperative symptom severity, postoperative ability to belch, dysphagia, medication use, and lifestyle. CONCLUSION: A patient's surgeon has an effect on satisfaction with antireflux surgery. Further research should clarify specific practices of the surgeon (patient selection, operative technique, followup) associated with best outcome.

Factors affecting the number of lymph nodes retrieved in colorectal cancer specimens.

BACKGROUND: Staging of colorectal cancer is dependent on the number of lymph nodes in a surgical specimen that are positive for metastatic cancer. It is generally recommended that a minimum of 12 lymph nodes be examined to ensure adequate staging. It is unclear which factors specifically contribute to variation in the number of lymph nodes retrieved from surgical specimens. This study aims to understand the factors affecting the number of lymph nodes identified in surgical colorectal cancer specimens. METHODS: A total of 264 retrospectively collected cases of colorectal cancer surgically treated at the University Health Network in Toronto from 2004 to 2006 were analyzed. We used univariate analyses of variance (ANOVA), and univariate and multivariable linear and logistic regression analyses to study variation in the lymph node number associated with a variety of explanatory variables. RESULTS: The average number of lymph nodes retrieved per case was 18.1, with 70 (26.5%) cases containing fewer than 12. Variation in the lymph node number was greatest between different pathology assistants (p = or< 0.001). The mean number of nodes retrieved by different pathology assistants ranged from 12.6 to 29.7. On average, surgery for recurrent cancer removed 6.0 (95% CI 1.2 to 10.9, p = 0.02) fewer lymph nodes than for primary cancer. Each additional year of patient age was associated with retrieval of 0.1 (95% CI 0.04 to 0.2, p = 0.005) fewer nodes, and rectal cancer specimens had 2.7 (95% CI 0.04 to 5.4, p = 0.05) fewer lymph nodes than colon cancer specimens. CONCLUSION: Most of the variation in the number of lymph nodes identified in surgical specimens from colorectal cancer operations was accounted for by differences between pathology assistants.

Adoption of an innovation to repair aortic aneurysms at a Canadian hospital: a qualitative case study and evaluation.

BACKGROUND: Priority setting in health care is a challenge because demand for services exceeds available resources. The increasing demand for less invasive surgical procedures by patients, health care institutions and industry, places added pressure on surgeons to acquire the appropriate skills to adopt innovative procedures. Such innovations are often initiated and introduced by surgeons in the hospital setting. Decision-making processes for the adoption of surgical innovations in hospitals have not been well studied and a standard process for their introduction does not exist. The purpose of this study is to describe and evaluate the decision-making process for the adoption of a new technology for repair of abdominal aortic aneurysms (endovascular aneurysm repair [EVAR]) in an academic health sciences centre to better understand how decisions are made for the introduction of surgical innovations at the hospital level. METHODS: A qualitative case study of the decision to adopt EVAR was conducted using a modified thematic analysis of documents and semi-structured interviews. Accountability for Reasonableness was used as a conceptual framework for fairness in priority setting processes in health care organizations. RESULTS: There were two key decisions regarding EVAR: the decision to adopt the new technology in the hospital and the decision to stop hospital funding. The decision to adopt EVAR was based on perceived improved patient outcomes, safety, and the surgeons' desire to innovate. This decision involved very few stakeholders. The decision to stop funding of EVAR involved all key players and was based on criteria apparent to all those involved, including cost, evidence and hospital priorities. Limited internal communications were made prior to adopting the technology. There was no formal means to appeal the decisions made. CONCLUSION: The analysis yielded recommendations for improving future decisions about the adoption of surgical innovations. ese empirical findings will be used with other case studies to help develop guidelines to help decision-makers adopt surgical innovations in Canadian hospitals.

Attitudes of patients and care providers toward a surgical site marking policy.

BACKGROUND: In the fall of 2005, the University Health Network in Toronto, Canada, initiated a policy requiring the surgeon-or his or her delegate-to sign the incision site for all operations. Little is known about what health care providers and patients think about official surgical site marking policy. METHOD: Twenty-one patients and health care providers were interviewed, and the authors conducted field observations of surgeons while they marked their patients. The data were analyzed using grounded theory methods. FINDINGS: Surgical site marking was perceived to be a safety precaution for operations involving multiple sides and structures but not for cases where there is no uncertainty about the intended operative site. Participants believed that marking could also facilitate error if the wrong side was marked. Site marking was perceived to have the effect of ensuring that the surgeon meets with the patient prior to the operation on the day of surgery. Concerns were raised with respect to who should mark patients and marking surgical sites for genital surgery or other private body sites. CONCLUSIONS: For operations that involve multiple possible surgical sites, site marking should be carried out by individuals who are knowledgeable about the patient and the proposed procedure. For operations in which there is no uncertainty about the intended site, interventions other than site marking could be implemented to ensure patient-surgeon interactions on the day of surgery. Surgical site marking procedures should respect patient dignity and privacy.

Risk factors for bile duct injury during laparoscopic cholecystectomy: a case-control study.

Common bile duct injury is a serious but uncommon complication of laparoscopic cholecystectomy. A case-control epidemiologic study of patients who had undergone cholecystectomy in Ontario, Canada, between 1991 and 1997 was performed. Four patients who had undergone a laparoscopic cholecystectomy at the same hospital 2 months prior to a case were selected as controls. The risk of bile duct injury associated with various exposures was estimated by unconditional logistic regression. There were 28 cases and 88 controls. Emergency operation (adjusted odds ratio = 5.0; 95% confidence interval, 1.4-17.8) and failure to identify the cystic duct (adjusted odds ratio = 13.7; 95% confidence interval, 2.5-76.3) were statistically significant risk factors for operative bile duct injury. No other characteristics were independent risk factors for bile duct injury. Failure to identify the cystic duct and the emergency surgery are independent risk factors for bile duct injury.

How are decisions to introduce new surgical technologies made? Advanced laparoscopic surgery at a Canadian community hospital: A qualitative case study and evaluation.

The introduction of many new surgical technologies is associated with increased costs and uncertainty regarding risks and benefits. Currently, little is known about how decisions are made regarding the adoption of surgical innovations. To study the decision-making process for adoption of advanced laparoscopic surgical procedures at a community hospital in Toronto, Canada, we used qualitative case study methods. Data were collected using semi-structured interviews with key informants. We performed a modified thematic analysis of the data, using the conceptual framework for priority setting known as accountability for reasonableness, which consists of 4 conditions: relevance, publicity, appeals, and enforcement. Several advanced laparoscopic surgical procedures were introduced at the hospital between 2000 and 2005. During that time, there was no structured, explicit process for making decisions about introducing new surgical technologies. Use of the new surgical technologies was relevant, as measured by the perception of patient benefit and alignment with the hospital's strategic priorities. There was no systematic structure in place to oversee publicity, appeals, or enforcement. The decision to adopt advanced laparoscopic surgery at a community hospital in Toronto, Canada, was made primarily on the basis of its relevance to patient care. The process for making decisions about the adoption of new surgical technologies can be improved.

A measure of quality of life after abdominal surgery.

OBJECTIVE: To develop a reliable and valid measure of short-term quality of life after abdominal surgery. SUMMARY BACKGROUND DATA: A major limitation of clinical trials evaluating laparoscopic surgical procedures has been the lack of a measure of short-term quality of life after abdominal surgery. METHODS: We used existing health status measures, focus groups, and semi-structured patient interviews to generate a prototype questionnaire of 51 items, which was administered to patients within 2 weeks after an abdominal surgical procedure. We used structural equations modeling to reduce the number of items, retaining the three items with the highest factor loadings on each of the factors that accounted for one or more eigenvalue. RESULTS: We administered the prototype questionnaire to 500 patients (mean age [SD] 53.4 [16.0], 51.4% male, 73.0% inpatient) at a mean 4.1 days after an abdominal surgical procedure. Item reduction yielded an 18-item measure with 6 sub-scales. The final instrument demonstrated good model fit in relation to our hypothesized factors (root mean square error of approximation 0.085, goodness-of-fit index 0.89). CONCLUSIONS: We developed a reliable and valid 18-item, 6-subscale measure of health-related quality of life after abdominal surgery, for use as an outcome measure in studies comparing laparoscopic and conventional abdominal surgery.

Short-term health-related quality of life after abdominal surgery: a conceptual framework.

We sought to develop a conceptual framework of health-related quality of life (QOL) after abdominal surgery to assist in the development of a QOL measure suitable for use in clinical trials comparing laparoscopic and conventional surgery. We conducted semi-structured interviews with 21 patients within 2 weeks after an abdominal surgical procedure. Responses were transferred into an electronic spreadsheet and coded to facilitate analysis. We tabulated the frequency of similar responses and grouped response items into areas of QOL impairment. The patients ranged in age from 19 to 78 years. Six had laparoscopic procedures. Patients identified the following areas of QOL impairment (examples of specific items and frequency of response): (1) physical limitations (difficulty getting in and out of bed 52%, difficulty walking 48%), (2) functional impairment (inability to perform usual activities 100%, difficulty bathing 90%), (3) pain (pain in incision 48%, pain with coughing or movement 28%), (4) visceral function (inability to eat 48%, lack of appetite 43%), (5) sleep (frequent nighttime awakening 62%, difficulty falling asleep 33%), and (6) mood (helplessness 28%, anxiety 24%). Acute health status after abdominal surgery constitutes a unique, dynamic health state characterized by impairment in a number of different health domains. A measure of QOL after abdominal surgery should have adequate coverage of these health concepts.

A measure of disease-specific health-related quality of life for achalasia.

OBJECTIVES: To develop a measure of disease-specific health-related quality of life for achalasia for use as an outcome measure in clinical trials. METHODS: We generated a list of potential items for a measure of disease-specific health-related quality of life for achalasia by semistructured interviews with seven persons with achalasia, and by expert opinion. We then used factor analysis and item response theory methods for item reduction, using responses on the long-form questionnaire from 70 persons with achalasia. The severity measure underlying the item responses was constructed using a Rasch model. RESULTS: We developed a 10-item measure of disease-specific health-related quality of life that sampled the concepts of food tolerance, dysphagia-related behavior modifications, pain, heartburn, distress, lifestyle limitation, and satisfaction. The measure was reliable (person separation reliability 0.79, Cronbach's alpha 0.83), showed evidence of construct validity and good data-to-model fit (mean infit and outfit statistics for items, 1.00 and 0.98, respectively), and had a wide effective measurement range (able to discriminate between 87% of subjects with achalasia). The measure was recalibrated onto a 0-100 interval-level scale. CONCLUSIONS: We describe a reliable measure of achalasia disease-specific health-related quality of life that has a broad effective measurement range, interval-level properties, and evidence of construct validity. This measure is appropriate for use as an outcome measure in clinical trials and other evaluative studies on the effectiveness of treatment for achalasia.