To develop decision trees based on prospectively collected data for determining the appropriatene... more To develop decision trees based on prospectively collected data for determining the appropriateness of cataract extraction. Prospective observational cohort study. Consecutive patients with a diagnosis of cataract who are on waiting lists to undergo cataract extraction by phacoemulsification. 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. Preintervention VA and changes 6 weeks after the intervention. 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. 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.
To develop decision trees based on prospectively collected data for determining the appropriatene... more To develop decision trees based on prospectively collected data for determining the appropriateness of cataract extraction. Prospective observational cohort study. Consecutive patients with a diagnosis of cataract who are on waiting lists to undergo cataract extraction by phacoemulsification. 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. Preintervention VA and changes 6 weeks after the intervention. 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. 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.
International Journal of Technology Assessment in Health Care, 2008
The aim of this study was to explore the needs and requirements of decision makers in our regiona... more 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. 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. 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. 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.
BACKGROUND An increasing number of initiatives involve patients in the development of Clinical Pr... more BACKGROUND An increasing number of initiatives involve patients in the development of Clinical Practice Guidelines (CPGs). However, the method used for patient involvement is fundamental to achieving a quality patient-oriented CPG. The objective is to present a strategy for patient involvement that includes both robust patient consultation and participation. This strategy is based on the authors' experience in the development of four CPGs included in the Spanish National CPG Development Program, which deemed it a valuable nation-wide patient involvement initiative. METHODS Patient consultation in the CPG preparation phase combines quantitative and qualitative primary research techniques as well as a systematic review of patient-perspective studies. Participation relies on patients and patient representatives as members of the guideline development groups in all development phases at the same level as professionals. NVivo 8 software was used to analyse discourses of qualitative data. RESULTS Patients and patient representatives provided relevant information on their perspectives, experiences with the illness, social circumstances, habits, values and preferences. They collaborated in different CPG development phases, including setting the scope and objectives, defining key research questions, writing and reviewing recommendations, developing patients' versions and the dissemination of CPGs. CONCLUSIONS The authors' strategy allows for patient-oriented CPG development, but it requires appropriate training and knowledge of qualitative research techniques (primary research and systematic review of qualitative evidence) for developers. It is also crucial to have specific support for patients, previously selected with eligibility criteria, to facilitate an effective engagement, providing clear guidance on their roles and ensuring opportunities to attend training events.
International Journal of Technology Assessment in Health Care, 2009
Health Technology Assessment (HTA) is a relatively new concept in Latin America (LA). The objecti... more 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. 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. 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). 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.
Objetive To assess the safety and efficacy of FDG-PET in breast cancer in the diagnostic of prima... more Objetive To assess the safety and efficacy of FDG-PET in breast cancer in the diagnostic of primary tumours, lymph node staging, the detection of recurrent disease/metastases, and the assessment of chemotherapy treatment. Methods A systematic review was undertaken. A search was made for primary studies, other systematic reviews, and health technology assessment reports in different databases. Results A total of 73 reports were included. FDG-PET does not appear to be sufficiently accurate to be used in isolation for ruling out the presence of a primary tumour. In lymph gland staging, FDG-PET does not appear to be accurate enough to detect occult axillary metastases or micrometastases (sensitivity 20 and 50%, respectively); sentinel node biopsy is required for confirmation. In the detection of bone metastases, FDG-PET should be complemented with other tests such as bone gammagraphy or SPECT. The assessment of response to chemotherapy, there seems to be no uniform criterion for establishing a standardized uptake value (SUV) for FDG that would allow responders and non-responders to be distinguished. Conclusions FDG-PET is insufficiently sensitive to rule out small primary tumours. Due to the high number of false positives returned, it cannot replace axillary dissection in axillary lymph gland staging. A complete biochemical response identified by FDG-PET should not be relied upon to mean an absence of disease since the technique cannot detect residual microscopic elements.
To develop decision trees based on prospectively collected data for determining the appropriatene... more To develop decision trees based on prospectively collected data for determining the appropriateness of cataract extraction. Prospective observational cohort study. Consecutive patients with a diagnosis of cataract who are on waiting lists to undergo cataract extraction by phacoemulsification. 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. Preintervention VA and changes 6 weeks after the intervention. 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. 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.
To develop decision trees based on prospectively collected data for determining the appropriatene... more To develop decision trees based on prospectively collected data for determining the appropriateness of cataract extraction. Prospective observational cohort study. Consecutive patients with a diagnosis of cataract who are on waiting lists to undergo cataract extraction by phacoemulsification. 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. Preintervention VA and changes 6 weeks after the intervention. 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. 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.
International Journal of Technology Assessment in Health Care, 2008
The aim of this study was to explore the needs and requirements of decision makers in our regiona... more 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. 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. 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. 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.
BACKGROUND An increasing number of initiatives involve patients in the development of Clinical Pr... more BACKGROUND An increasing number of initiatives involve patients in the development of Clinical Practice Guidelines (CPGs). However, the method used for patient involvement is fundamental to achieving a quality patient-oriented CPG. The objective is to present a strategy for patient involvement that includes both robust patient consultation and participation. This strategy is based on the authors' experience in the development of four CPGs included in the Spanish National CPG Development Program, which deemed it a valuable nation-wide patient involvement initiative. METHODS Patient consultation in the CPG preparation phase combines quantitative and qualitative primary research techniques as well as a systematic review of patient-perspective studies. Participation relies on patients and patient representatives as members of the guideline development groups in all development phases at the same level as professionals. NVivo 8 software was used to analyse discourses of qualitative data. RESULTS Patients and patient representatives provided relevant information on their perspectives, experiences with the illness, social circumstances, habits, values and preferences. They collaborated in different CPG development phases, including setting the scope and objectives, defining key research questions, writing and reviewing recommendations, developing patients' versions and the dissemination of CPGs. CONCLUSIONS The authors' strategy allows for patient-oriented CPG development, but it requires appropriate training and knowledge of qualitative research techniques (primary research and systematic review of qualitative evidence) for developers. It is also crucial to have specific support for patients, previously selected with eligibility criteria, to facilitate an effective engagement, providing clear guidance on their roles and ensuring opportunities to attend training events.
International Journal of Technology Assessment in Health Care, 2009
Health Technology Assessment (HTA) is a relatively new concept in Latin America (LA). The objecti... more 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. 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. 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). 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.
Objetive To assess the safety and efficacy of FDG-PET in breast cancer in the diagnostic of prima... more Objetive To assess the safety and efficacy of FDG-PET in breast cancer in the diagnostic of primary tumours, lymph node staging, the detection of recurrent disease/metastases, and the assessment of chemotherapy treatment. Methods A systematic review was undertaken. A search was made for primary studies, other systematic reviews, and health technology assessment reports in different databases. Results A total of 73 reports were included. FDG-PET does not appear to be sufficiently accurate to be used in isolation for ruling out the presence of a primary tumour. In lymph gland staging, FDG-PET does not appear to be accurate enough to detect occult axillary metastases or micrometastases (sensitivity 20 and 50%, respectively); sentinel node biopsy is required for confirmation. In the detection of bone metastases, FDG-PET should be complemented with other tests such as bone gammagraphy or SPECT. The assessment of response to chemotherapy, there seems to be no uniform criterion for establishing a standardized uptake value (SUV) for FDG that would allow responders and non-responders to be distinguished. Conclusions FDG-PET is insufficiently sensitive to rule out small primary tumours. Due to the high number of false positives returned, it cannot replace axillary dissection in axillary lymph gland staging. A complete biochemical response identified by FDG-PET should not be relied upon to mean an absence of disease since the technique cannot detect residual microscopic elements.
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