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Value in Health : the Journal of the... 2005In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create...
Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation.
In 1999, ISPOR formed the Quality of Life Special Interest group (QoL-SIG)--Translation and Cultural Adaptation group (TCA group) to stimulate discussion on and create guidelines and standards for the translation and cultural adaptation of patient-reported outcome (PRO) measures. After identifying a general lack of consistency in current methods and published guidelines, the TCA group saw a need to develop a holistic perspective that synthesized the full spectrum of published methods. This process resulted in the development of Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice (PGP), a report on current methods, and an appraisal of their strengths and weaknesses. The TCA Group undertook a review of evidence from current practice, a review of the literature and existing guidelines, and consideration of the issues facing the pharmaceutical industry, regulators, and the broader outcomes research community. Each approach to translation and cultural adaptation was considered systematically in terms of rationale, components, key actors, and the potential benefits and risks associated with each approach and step. The results of this review were subjected to discussion and challenge within the TCA group, as well as consultation with the outcomes research community at large. Through this review, a consensus emerged on a broad approach, along with a detailed critique of the strengths and weaknesses of the differing methodologies. The results of this review are set out as "Translation and Cultural Adaptation of Patient Reported Outcomes Measures--Principles of Good Practice" and are reported in this document.
Topics: Advisory Committees; Attitude to Health; Culture; Health Services Research; Humans; Outcome Assessment, Health Care; Psychometrics; Quality of Life; Reproducibility of Results; Sickness Impact Profile; Surveys and Questionnaires; Translating
PubMed: 15804318
DOI: 10.1111/j.1524-4733.2005.04054.x -
Journal of Clinical Epidemiology Aug 2021
Topics: Delivery of Health Care; Health Services Research; Humans; Outcome Assessment, Health Care
PubMed: 34489051
DOI: 10.1016/j.jclinepi.2021.08.015 -
Value in Health : the Journal of the... Jun 2011The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the...
BACKGROUND
The application of conjoint analysis (including discrete-choice experiments and other multiattribute stated-preference methods) in health has increased rapidly over the past decade. A wider acceptance of these methods is limited by an absence of consensus-based methodological standards.
OBJECTIVE
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Research Practices for Conjoint Analysis Task Force was established to identify good research practices for conjoint-analysis applications in health.
METHODS
The task force met regularly to identify the important steps in a conjoint analysis, to discuss good research practices for conjoint analysis, and to develop and refine the key criteria for identifying good research practices. ISPOR members contributed to this process through an extensive consultation process. A final consensus meeting was held to revise the article using these comments, and those of a number of international reviewers.
RESULTS
Task force findings are presented as a 10-item checklist covering: 1) research question; 2) attributes and levels; 3) construction of tasks; 4) experimental design; 5) preference elicitation; 6) instrument design; 7) data-collection plan; 8) statistical analyses; 9) results and conclusions; and 10) study presentation. A primary question relating to each of the 10 items is posed, and three sub-questions examine finer issues within items.
CONCLUSIONS
Although the checklist should not be interpreted as endorsing any specific methodological approach to conjoint analysis, it can facilitate future training activities and discussions of good research practices for the application of conjoint-analysis methods in health care studies.
Topics: Advisory Committees; Checklist; Delivery of Health Care; Economics, Pharmaceutical; Humans; Internationality; Outcome Assessment, Health Care; Research Design; Research Report
PubMed: 21669364
DOI: 10.1016/j.jval.2010.11.013 -
Archives of Disease in Childhood.... Jun 2018
Topics: Clinical Trials as Topic; Humans; Outcome Assessment, Health Care; Pediatrics; Practice Guidelines as Topic; Research Design
PubMed: 28667046
DOI: 10.1136/archdischild-2016-312117 -
Journal of Comparative Effectiveness... Mar 2016Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to... (Review)
Review
Policy makers have clearly indicated--through heavy investment in the Patient Centered Outcomes Research Institute--that reporting outcomes that are meaningful to patients is crucial for improvement in healthcare delivery and cost reduction. Better interpretation and generalizability of clinical research results that incorporate patient-centered outcomes research can be achieved by accelerating the development and uptake of core outcome sets (COS). COS provide a standardized minimum set of the outcomes that should be measured and reported in all clinical trials of a specific condition. The level of activity around COS has increased significantly over the past decade, with substantial progress in several clinical domains. However, there are many important clinical conditions for which high-quality COS have not been developed and there are limited resources and capacity with which to develop them. We believe that meaningful progress toward the goals behind the significant investments in patient-centered outcomes research and comparative effectiveness research will depend on a serious effort to address these issues.
Topics: Comparative Effectiveness Research; Delivery of Health Care; Humans; Outcome Assessment, Health Care; Research Design
PubMed: 26930385
DOI: 10.2217/cer-2015-0007 -
Value in Health : the Journal of the... Mar 2008
Topics: Asia, Southeastern; Economics, Medical; Economics, Pharmaceutical; Health Services Research; Humans; Outcome Assessment, Health Care
PubMed: 18387052
DOI: 10.1111/j.1524-4733.2008.00360.x -
Current Opinion in Anaesthesiology Jun 2019To review the developments within paediatric anaesthesia and describe the various factors that have contributed to the improvements in anaesthesia-related outcomes in... (Review)
Review
PURPOSE OF REVIEW
To review the developments within paediatric anaesthesia and describe the various factors that have contributed to the improvements in anaesthesia-related outcomes in children.
RECENT FINDINGS
During the years substantial improvements in paediatric anaesthesia-related outcomes has derived from safety advances in equipment, drugs, human factor analysis, professional standardization and organization, subspecialty care and regionalization. However, universally agreed outcome measures are lacking.
SUMMARY
Despite a steadily and significant improvement in paediatric anaesthesia-related outcomes over the years further and future improvements are still necessary in areas such as adverse-event reporting and long-term neurocognitive outcomes with much more focus on patient/family-centred outcomes. Clinical experts and stakeholders should meet and agree on a consensus to identify indicators that could act as outcome measures in future large-scale prospective observational studies and clinical trials. Such an approach will foster benchmarking and continuous quality assessment and improvement at individual, institutional, interinstitutional, regional, national and international levels and facilitate larger scale clinical research. Furthermore, it will attain a high public health importance and will facilitate comparisons between healthcare provision models leading to optimization of perioperative care delivery.
Topics: Anesthesia; Benchmarking; Child; Clinical Trials as Topic; Humans; Observational Studies as Topic; Outcome Assessment, Health Care; Perioperative Care; Quality Improvement
PubMed: 31045641
DOI: 10.1097/ACO.0000000000000720 -
Current Problems in Pediatric and... Dec 2021Healthcare and outcomes for children with medical complexity (CMC) and their families can be improved by conducting well-conceived, designed, implemented, and analyzed...
Healthcare and outcomes for children with medical complexity (CMC) and their families can be improved by conducting well-conceived, designed, implemented, and analyzed research studies of clinical interventions. This article presents a framework for how to approach the study of clinical interventions for CMC, including 7 key questions and example answers to each: (1) What intervention questions should be our focus? (2) What barriers to intervention research exist? (3) How do we design and optimize interventions? (4) How do we characterize and select patients to enroll? (5) How can we enhance data collection and integration? (6) How can we improve enrollment and participation? And (7) which intervention experimental designs should we choose? By exploring each of these key aspects of intervention-based research, we hope to expand thinking about and spark ideas for specific research projects focused on clinical interventions for CMC.
Topics: Child; Humans; Outcome Assessment, Health Care; Pediatrics
PubMed: 34996708
DOI: 10.1016/j.cppeds.2021.101126 -
Pain Mar 2022
Topics: Humans; Outcome Assessment, Health Care; Pain; Pain Management
PubMed: 35148287
DOI: 10.1097/j.pain.0000000000002373 -
Implementation Science : IS Jul 2023Proctor and colleagues' 2011 paper proposed a taxonomy of eight implementation outcomes and challenged the field to address a research agenda focused on... (Review)
Review
BACKGROUND
Proctor and colleagues' 2011 paper proposed a taxonomy of eight implementation outcomes and challenged the field to address a research agenda focused on conceptualization, measurement, and theory building. Ten years later, this paper maps the field's progress in implementation outcomes research. This scoping review describes how each implementation outcome has been studied, research designs and methods used, and the contexts and settings represented in the current literature. We also describe the role of implementation outcomes in relation to implementation strategies and other outcomes.
METHODS
Arksey and O'Malley's framework for conducting scoping reviews guided our methods. Using forward citation tracing, we identified all literature citing the 2011 paper. We conducted our search in the Web of Science (WOS) database and added citation alerts sent to the first author from the publisher for a 6-month period coinciding with the WOS citation search. This produced 1346 titles and abstracts. Initial abstract screening yielded 480 manuscripts, and full-text review yielded 400 manuscripts that met inclusion criteria (empirical assessment of at least one implementation outcome).
RESULTS
Slightly more than half (52.1%) of included manuscripts examined acceptability. Fidelity (39.3%), feasibility (38.6%), adoption (26.5%), and appropriateness (21.8%) were also commonly examined. Penetration (16.0%), sustainability (15.8%), and cost (7.8%) were less frequently examined. Thirty-two manuscripts examined implementation outcomes not included in the original taxonomy. Most studies took place in healthcare (45.8%) or behavioral health (22.5%) organizations. Two-thirds used observational designs. We found little evidence of progress in testing the relationships between implementation strategies and implementation outcomes, leaving us ill-prepared to know how to achieve implementation success. Moreover, few studies tested the impact of implementation outcomes on other important outcome types, such as service systems and improved individual or population health.
CONCLUSIONS
Our review presents a comprehensive snapshot of the research questions being addressed by existing implementation outcomes literature and reveals the need for rigorous, analytic research and tests of strategies for attaining implementation outcomes in the next 10 years of outcomes research.
Topics: Humans; Delivery of Health Care; Outcome Assessment, Health Care
PubMed: 37491242
DOI: 10.1186/s13012-023-01286-z