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Implementation Science : IS Aug 2017Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual...
BACKGROUND
Implementation outcome measures are essential for monitoring and evaluating the success of implementation efforts. Yet, currently available measures lack conceptual clarity and have largely unknown reliability and validity. This study developed and psychometrically assessed three new measures: the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
METHODS
Thirty-six implementation scientists and 27 mental health professionals assigned 31 items to the constructs and rated their confidence in their assignments. The Wilcoxon one-sample signed rank test was used to assess substantive and discriminant content validity. Exploratory and confirmatory factor analysis (EFA and CFA) and Cronbach alphas were used to assess the validity of the conceptual model. Three hundred twenty-six mental health counselors read one of six randomly assigned vignettes depicting a therapist contemplating adopting an evidence-based practice (EBP). Participants used 15 items to rate the therapist's perceptions of the acceptability, appropriateness, and feasibility of adopting the EBP. CFA and Cronbach alphas were used to refine the scales, assess structural validity, and assess reliability. Analysis of variance (ANOVA) was used to assess known-groups validity. Finally, half of the counselors were randomly assigned to receive the same vignette and the other half the opposite vignette; and all were asked to re-rate acceptability, appropriateness, and feasibility. Pearson correlation coefficients were used to assess test-retest reliability and linear regression to assess sensitivity to change.
RESULTS
All but five items exhibited substantive and discriminant content validity. A trimmed CFA with five items per construct exhibited acceptable model fit (CFI = 0.98, RMSEA = 0.08) and high factor loadings (0.79 to 0.94). The alphas for 5-item scales were between 0.87 and 0.89. Scale refinement based on measure-specific CFAs and Cronbach alphas using vignette data produced 4-item scales (α's from 0.85 to 0.91). A three-factor CFA exhibited acceptable fit (CFI = 0.96, RMSEA = 0.08) and high factor loadings (0.75 to 0.89), indicating structural validity. ANOVA showed significant main effects, indicating known-groups validity. Test-retest reliability coefficients ranged from 0.73 to 0.88. Regression analysis indicated each measure was sensitive to change in both directions.
CONCLUSIONS
The AIM, IAM, and FIM demonstrate promising psychometric properties. Predictive validity assessment is planned.
Topics: Factor Analysis, Statistical; Feasibility Studies; Female; Health Plan Implementation; Humans; Male; Outcome Assessment, Health Care; Psychometrics; Reproducibility of Results; Surveys and Questionnaires
PubMed: 28851459
DOI: 10.1186/s13012-017-0635-3 -
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 -
JAMA Network Open Nov 2019Malnutrition affects a considerable proportion of the medical inpatient population. There is uncertainty regarding whether use of nutritional support during... (Meta-Analysis)
Meta-Analysis
Association of Nutritional Support With Clinical Outcomes Among Medical Inpatients Who Are Malnourished or at Nutritional Risk: An Updated Systematic Review and Meta-analysis.
IMPORTANCE
Malnutrition affects a considerable proportion of the medical inpatient population. There is uncertainty regarding whether use of nutritional support during hospitalization in these patients positively alters their clinical outcomes.
OBJECTIVE
To assess the association of nutritional support with clinical outcomes in medical inpatients who are malnourished or at nutritional risk.
DATA SOURCES
For this updated systematic review and meta-analysis, a search of the Cochrane Library, MEDLINE, and Embase was conducted from January 1, 2015, to April 30, 2019; the included studies were published between 1982 and 2019.
STUDY SELECTION
A prespecified Cochrane protocol was followed to identify trials comparing oral and enteral nutritional support interventions with usual care and the association of these treatments with clinical outcomes in non-critically ill medical inpatients who were malnourished.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently extracted data and assessed risk of bias; data were pooled using a random-effects model.
MAIN OUTCOMES AND MEASURES
The primary outcome was mortality. The secondary outcomes included nonelective hospital readmissions, length of hospital stay, infections, functional outcome, daily caloric and protein intake, and weight change.
RESULTS
A total of 27 trials (n = 6803 patients) were included, of which 5 (n = 3067 patients) were published between 2015 and 2019. Patients receiving nutritional support compared with patients in the control group had significantly lower rates of mortality (230 of 2758 [8.3%] vs 307 of 2787 [11.0%]; odds ratio [OR], 0.73; 95% CI, 0.56-0.97). A sensitivity analysis suggested a more pronounced reduction in the risk of mortality in recent trials (2015 or later) (OR, 0.47; 95% CI, 0.28-0.79) compared with that in older studies (OR, 0.94; 95% CI, 0.72-1.22), in patients with established malnutrition (OR, 0.52; 95% CI, 0.34-0.80) compared with that in patients at nutritional risk (OR, 0.85; 95% CI, 0.62-1.18), and in trials with high protocol adherence (OR, 0.67; 95% CI, 0.54-0.84) compared with that in trials with low protocol adherence (OR, 0.88; 95% CI, 0.44-1.76). Nutritional support was also associated with a reduction in nonelective hospital readmissions (14.7% vs 18.0%; risk ratio, 0.76; 95% CI, 0.60-0.96), higher energy intake (mean difference, 365 kcal; 95% CI, 272-458 kcal) and protein intake (mean difference, 17.7 g; 95% CI, 12.1-23.3 g), and weight increase (0.73 kg; 95% CI, 0.32-1.13 kg). No significant differences were observed in rates of infections (OR, 0.86; 95% CI, 0.64-1.16), functional outcome (mean difference, 0.32; 95% CI, -0.51 to 1.15), and length of hospital stay (mean difference, -0.24; 95% CI, -0.58 to 0.09).
CONCLUSIONS AND RELEVANCE
This study's findings suggest that despite heterogeneity and varying methodological quality among trials, nutritional support was associated with improved survival and nonelective hospital readmission rates among medical inpatients who were malnourished and should therefore be considered when treating this population.
Topics: Adult; Hospitalization; Humans; Inpatients; Malnutrition; Nutrition Therapy; Nutritional Status; Outcome Assessment, Health Care; Quality of Health Care
PubMed: 31747030
DOI: 10.1001/jamanetworkopen.2019.15138 -
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 Neurosurgical Anesthesiology Jan 2019The Pediatric Anesthesia and Neurodevelopment Assessment (PANDA) study team held its biennial symposium in April 2018 to discuss issues on anesthetic neurotoxicity in... (Review)
Review
The Pediatric Anesthesia and Neurodevelopment Assessment (PANDA) study team held its biennial symposium in April 2018 to discuss issues on anesthetic neurotoxicity in the developing brain. One of the sessions invited speakers with different areas of expertise to discuss "Outcomes Research in Vulnerable Pediatric Populations." The vulnerable populations included neonates, children with congenital heart disease, children from low socioeconomic status, and children with incarcerated parents. Each speaker presented some of the ongoing research efforts in these groups as well as the challenges encountered in studying them.
Topics: Anesthesia; Anesthetics; Developmental Disabilities; Heart Defects, Congenital; Humans; Infant; Infant, Newborn; Neurotoxicity Syndromes; Outcome Assessment, Health Care; Poverty; Socioeconomic Factors; United States; Vulnerable Populations
PubMed: 30767939
DOI: 10.1097/ANA.0000000000000544 -
Brain : a Journal of Neurology Dec 2023The capacity and power of data from cohorts, registries and randomized trials to provide answers to contemporary clinical questions in neurology has increased... (Review)
Review
The capacity and power of data from cohorts, registries and randomized trials to provide answers to contemporary clinical questions in neurology has increased considerably over the past two decades. Novel sophisticated statistical methods are enabling us to harness these data to guide treatment decisions, but their complexity is making appraisal of clinical evidence increasingly demanding. In this review, we discuss several methodological aspects of contemporary research of treatment effectiveness in observational data in neurology, aimed at academic neurologists and analysts specializing in outcomes research. The review discusses specifics of the sources of observational data and their key features. It focuses on the limitations of observational data and study design, as well as statistical approaches aimed to overcome these limitations. Among the examples of leading clinical themes typically studied with analyses of observational data, the review discusses methodological approaches to comparative treatment effectiveness, development of diagnostic criteria and definitions of clinical outcomes. Finally, this review provides a brief summary of key points that will help clinical audience critically evaluate design and analytical aspects of studies of disease outcomes using observational data.
Topics: Humans; Treatment Outcome; Outcome Assessment, Health Care; Registries; Research Design; Neurology
PubMed: 37587541
DOI: 10.1093/brain/awad278 -
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 Opinion in Anaesthesiology Dec 2022Recent advancements in big data analytical tools and large patient databases have expanded tremendously the opportunities to track patient and safety outcomes.We discuss... (Review)
Review
PURPOSE OF REVIEW
Recent advancements in big data analytical tools and large patient databases have expanded tremendously the opportunities to track patient and safety outcomes.We discuss the strengths and limitations of large databases and implementation in practice with a focus on the current opportunities to use technological advancements to improve patient safety.
RECENT FINDINGS
The most used sources of data for large patient safety observational studies are administrative databases, clinical registries, and electronic health records. These data sources have enabled research on patient safety topics ranging from rare adverse outcomes to large cohort studies of the modalities for pain control and safety of medications. Implementing the insights from big perioperative data research is augmented by automating data collection and tracking the safety outcomes on a provider, institutional, national, and global level. In the near future, big data from wearable devices, physiological waveforms, and genomics may lead to the development of personalized outcome measures.
SUMMARY
Patient safety research using large databases can provide actionable insights to improve outcomes in the perioperative setting. As datasets and methods to gain insights from those continue to grow, adopting novel technologies to implement personalized quality assurance initiatives can significantly improve patient care.
Topics: Humans; Databases, Factual; Electronic Health Records; Registries; Big Data; Outcome Assessment, Health Care
PubMed: 36302209
DOI: 10.1097/ACO.0000000000001201 -
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 -
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