Health technology assessment-based development of a Spanish breast cancer patient decision aid.

OBJECTIVES: The aim of this study was to develop a breast cancer Patient Decision Aid (PDA), using a Health Technology Assessment (HTA) process, to assist patients in their choice of therapeutic options, and to promote shared decision making among patients, healthcare professionals, and other interested parties. METHODS: A systematic review (SR) was conducted of existing breast cancer patient Decision Aids encountered in the main scientific journal databases and on institutional Web sites that create PDAs, together with a Qualitative Research (QR) study, using semi-structured interviews and focus group with stakeholders (patients, family members, and health professionals), with the aim of developing a PDA for breast cancer. RESULTS: The SR shows that PDAs in breast cancer not only increase patient knowledge of the illness, leading to more realistic expectations of treatment outcomes, but also reduce passivity in the decision-making process and facilitate the appropriate choice of treatment options in accordance with patient medical and personal preferences. The analysis of QR shows that both breast cancer patients and healthcare professionals agree that surgery, adjuvant treatments, and breast reconstruction represent the most important decisions to be made. Worry, anxiety, optimism, and trust in healthcare professionals were determined as factors that most affected patients subjective experiences of the illness. This HTA was used as the basis for developing a PDA software program. CONCLUSIONS: The SR and QR used in the development of this PDA for breast cancer allowed patients to access information, gain additional knowledge of their illness, make shared treatment decisions, and gave healthcare professionals a deeper insight into patient experiences of the disease.

Esophageal Doppler monitoring during colorectal resection offers cost-effective improvement of hemodynamic control.

OBJECTIVES: Hemodynamic control can improve the outcome of surgery. Esophageal Doppler monitoring measures blood flow by ultrasound waves. This work investigates the cost-effectiveness of this procedure during colorectal resection. METHODS: Meta-analyses of randomized controlled trials of esophageal Doppler monitoring used in colorectal resection were conducted to help determine its cost-effectiveness. An analytical decision model was used to compare the cost-effectiveness of strategies involving conventional clinical assessment with or without the measurement of central venous pressure, with or without esophageal Doppler monitoring. Avoided mortality and avoided major complications were used as measures of clinical effectiveness. RESULTS: In the meta-analyses comparing conventional clinical assessment plus central venous pressure monitoring with or without esophageal Doppler monitoring, statistically significant differences in total and major complications favoring the use of Doppler were found. No differences were seen in mortality. The use of esophageal Doppler monitoring was associated with lower costs, mainly due to fewer complications, shorter hospital stays and shorter surgery times. CONCLUSIONS: Although the information regarding the clinical effectiveness of esophageal Doppler monitoring in colorectal resection is limited, strategies including this form of blood flow monitoring may be cost-effective. Further comparisons of Doppler monitoring against other hemodynamic monitoring systems should be undertaken.

Efficacy of the Da Vinci surgical system in abdominal surgery compared with that of laparoscopy: a systematic review and meta-analysis.

AIM: The main aim of this review was to compare the safety and efficacy of the Da Vinci Surgical System (DVSS) and conventional laparoscopic surgery (CLS) in different types of abdominal intervention. SUMMARY OF BACKGROUND DATA: DVSS is an emerging laparoscopic technology. The surgeon directs the robotic arms of the system through a console by means of hand controls and pedals, making use of a stereoscopic viewing system. DVSS is currently being used in general, urological, gynecologic, and cardiothoracic surgery. METHODS: This systematic review analyses the best scientific evidence available regarding the safety and efficacy of DVSS in abdominal surgery. The results found were subjected to meta-analysis whenever possible. RESULTS: Thirty-one studies, 6 of them randomized control trials, involving 2166 patients that compared DVSS and CLS were examined. The procedures undertaken were fundoplication (9 studies, one also examining cholecystectomy), Heller myotomy (3 studies), gastric bypass (4), gastrectomy (2), bariatric surgery (1), cholecystectomy (4), splenectomy (1), colorectal resection (7), and rectopexy (1). DVSS was found to be associated with fewer Heller myotomy-related perforations, a more rapid intestinal recovery time after gastrectomy-and therefore a shorter hospital stay, a shorter hospital stay following cholecystectomy (although the duration of surgery was longer), longer colorectal resection surgery times, and a larger number of conversions to open surgery during gastric bypass. CONCLUSIONS: The publications reviewed revealed DVSS to offer certain advantages with respect to Heller myotomy, gastrectomy, and cholecystectomy. However, these results should be interpreted with caution until randomized clinical trials are performed and, with respect to oncologic indications, studies include variables such as survival.

Decision trees for indication of cataract surgery based on changes in visual acuity.

OBJECTIVE: To develop decision trees based on prospectively collected data for determining the appropriateness of cataract extraction. DESIGN: Prospective observational cohort study. PARTICIPANTS: Consecutive patients with a diagnosis of cataract who are on waiting lists to undergo cataract extraction by phacoemulsification. METHODS: Patients were randomly assigned to 1 of 2 independent cohorts: The derivation cohort included 3691 patients, and the validation cohort included 2416 patients. Sociodemographic and clinical data, including visual acuity (VA) and the Visual Function Index 14 (VF-14), were collected before and after cataract extraction. Univariate and multivariate linear regression, and regression trees analysis were performed in the derivation cohort. Decision trees obtained in the derivation cohort were validated in the validation cohort. Final results were divided into appropriate or inappropriate indications and compared with a previously established benchmark of desirable VA and VF-14 gain in relation to preintervention VA classes. MAIN OUTCOME MEASURES: Preintervention VA and changes 6 weeks after the intervention. RESULTS: Among patients with simple cataract, predictors of significant improvement in VA after cataract extraction were preintervention VA and negative surgical complexity. Among patients with cataract and other ocular comorbidity, preintervention visual function and expected postintervention VA also predicted change in VA. When compared with a benchmark based on the minimal clinically important difference in VA after cataract extraction, sensitivity for the decision trees was 83% for both diagnostic groups and specificities ranged from 36.2 to 54.8. CONCLUSIONS: A simple decision tree based on changes in VA can help identify appropriate patients for cataract extraction and be used to evaluate clinical practice or for quality control.

A content analysis of Health Technology Assessment programs in Latin America.

OBJECTIVES: Health Technology Assessment (HTA) is a relatively new concept in Latin America (LA). The objectives of this exploratory study were to identify HTA programs in LA, review HTA documents produced by those programs, and assess the extent to which HTA aims are being achieved. METHODS: An electronic search through two databases was performed to identify HTA programs in LA. A content analysis was performed on HTA documents (n = 236) produced by six programs between January 2000 and March 2007. Results were analyzed by comparing document content with the main goals of HTA. RESULTS: The number of HTA documents increased incrementally during the study period. The documents produced were mostly short HTA documents (82 percent) that assessed technologies such as drugs (31 percent), diagnostic and/or screening technologies (18 percent), or medical procedures (18 percent). Two-thirds (66 percent) of all HTA documents addressed issues related to clinical effectiveness and economic evaluations. Ethical, social, and/or legal issues were rarely addressed (<1 percent). The two groups most often targeted for dissemination of HTA information were third-party payers (55 percent) or government policy makers (41 percent). CONCLUSIONS: This study showed that while HTA programs in LA have attempted to address the main goals of HTA, they have done so through the production of short documents that focus on practical high-technology areas of importance to two specific target groups. Clinical and economic considerations still take precedence over ethical, social, and/or legal issues. Thus, an integrated conceptual framework in LA is wanting.

Responsiveness and clinically important differences for the VF-14 index, SF-36, and visual acuity in patients undergoing cataract surgery.

OBJECTIVE: To assess visual acuity (VA) and 2 questionnaires of health-related quality of life--the Visual Function 14 (VF-14) index and the Medical Outcomes Study Short Form 36 Health Survey (SF-36)--as instruments for capturing clinically important changes after cataract surgery. DESIGN: Prospective, observational study. PARTICIPANTS: Four thousand three hundred fifty-six consecutive patients attending ophthalmologic clinics in 17 hospitals in preparation for cataract surgery were recruited. METHODS: Clinical data were collected in the visit before the intervention and 6 weeks after surgery by ophthalmologists. Patients completed the questionnaires before surgery and 3 months after surgery. MAIN OUTCOME MEASURES: The VF-14 and SF-36 questionnaire results obtained before surgery and 3 months after the procedure and VA before the procedure and 6 weeks afterward. RESULTS: Positive mean changes in VA (+0.47) and VF-14 results (+24.03) indicated significant improvements after cataract surgery that were not reflected in changes in SF-36 domains (from 1.86 to 5.62). Responsiveness parameters demonstrated large changes in VA and VF-14 scores but not in SF-36 domains. The minimal clinically important differences (MCID) after surgery were 0.41 for VA and 15.57 for VF-14 results; the minimal detectable change (MDC) for VF-14 was 10.81. CONCLUSIONS: Visual acuity and VF-14 scores, but not SF-36 scores, are appropriate instruments for capturing clinically important changes after cataract surgery. The MCID and MDC values obtained herein, although not absolute thresholds, may aid in the interpretation of changes in VA and VF-14 scores.

Laparoscopic hysterectomy in the treatment of endometrial cancer: a systematic review.

We sought to compare the safety and efficacy of laparoscopic hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy and open surgery in women with endometrial cancer. A systematic review of the literature was undertaken. Bibliographic searches of the Health Technology Assessment, National Health Service Economic Evaluation, DARE, Cochrane Database of Systematic Reviews, MEDLINE, Embase, Pascal Biomed, and Cinahl databases were made. This study sought to include systematic reviews, health technology assessment reports, and randomized clinical trials comparing laparoscopic surgery (LS) with open surgery for the treatment of endometrial cancer. The quality of the included studies was assessed using a clinical trial checklist. The clinical studies finally included were 4 randomized clinical trials. The short-term results described show that LS offers advantages with respect to postoperative recovery, including reduced bleeding, a need for fewer days of intravenous fluid therapy, and a reduced need for pain killers. In addition, intraoperative and postoperative complications were fewer among those who underwent LS in all the studies consulted. The mean hospital stay of those who underwent LS was 3 to 4 days shorter, and they returned to normal activity sooner. The number of lymph glands resected was the same with both techniques. The LS was associated with a better quality of life after surgery. With respect to long-term results, no significant differences were found in relation to overall, disease-free or cause-specific survival, according to 1 study. The short-term results of LS are equivalent or better than those achieved with open surgery, whereas the long-term results obtained by both seems equivalent but more studies are needed assessing this outcome.

Defining products for a new health technology assessment agency in Madrid, Spain: a survey of decision makers.

OBJECTIVES: The aim of this study was to explore the needs and requirements of decision makers in our regional healthcare system for health technology assessment (HTA) products to support portfolio development planning for a new HTA agency in Madrid, Spain. METHODS: A Delphi study was conducted during 2003. Questionnaires were developed based on a review of products and services offered by other agency members of the International Network of Agencies for Health Technology Assessment, and included preference and prioritization questions to evaluate twenty-two different products and services. The initial Delphi panel involved eighty-seven experts from twenty-one public hospitals, eleven primary healthcare centers, six private hospitals, and eight departments of the Regional Ministry of Health of the Community of Madrid. RESULTS: The global participation rate was 83.9 percent. Ten of the twenty-two possible products were rated of high interest by more than 80 percent of respondents. Important differences in preferences and priorities were detected across different settings. Public hospitals and primary healthcare centers shared a more "micro" perspective, preferring classic technology-centered HTA products, whereas private hospitals and Ministry representatives demanded more "macro" products and services such as organizational model and information system assessments. CONCLUSIONS: The high participation rate supports the representativeness of the results for our regional context. The strategic development of an HTA portfolio based on decision makers' needs and requirements as identified in this type of exercise should help achieve a better impact on policy development and decision making.