Stakeholders\u27 views on data sharing in multicenter studies

AIM: To understand stakeholders\u27 views on data sharing in multicenter comparative effectiveness research studies and the value of privacy-protecting methods. MATERIALS and METHODS: Semistructured interviews with five US stakeholder groups. RESULTS: We completed 11 interviews, involving patients (n = 15), researchers (n = 10), Institutional Review Board and regulatory staff (n = 3), multicenter research governance experts (n = 2) and healthcare system leaders (n = 4). Perceptions of the benefits and value of research were the strongest influences toward data sharing; cost and security risks were primary influences against sharing. Privacy-protecting methods that share summary-level data were acknowledged as being appealing, but there were concerns about increased cost and potential loss of research validity. CONCLUSION: Stakeholders were open to data sharing in multicenter studies that offer value and minimize security risks

The positive predictive value of a hyperkalemia diagnosis in automated health care data

Our objectives were to determine performance of coded hyperkalemia diagnosis at identifying 1) clinically-evident hyperkalemia and 2) serum potassium ≥ 6 mmol/liter

Planning for Implementation Success Using RE-AIM and CFIR Frameworks: A Qualitative Study

Background: RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) and CFIR (Consolidated Framework for Implementation Research) dissemination and implementation frameworks define theory-based domains associated with the adoption, implementation and maintenance of evidence-based interventions. Used together, the two frameworks identify metrics for evaluating implementation success, i.e., high reach and effectiveness resulting in sustained practice change (RE-AIM), and modifiable factors that explain and enhance implementation outcomes (CFIR). We applied both frameworks to study the implementation planning process for a technology-delivered asthma care intervention called Breathewell within an integrated care organization. The goal of the Breathewell intervention is to increase the efficiency of delivering resource-intensive asthma care services. Methods: We reviewed historical documents (i.e., meeting agendas; minutes) from 14 months of planning to evaluate alignment of implementation team priorities with RE-AIM domains. Key content was extracted and analyzed on topics, frequency and amount of discussion within each RE-AIM domain. Implementation team members were interviewed using questions adapted from the CFIR Interview Guide Tool to focus their reflection on the process and contextual factors considered during pre-implementation planning. Documents and transcripts were initially coded using RE-AIM domain definitions, and recoded using CFIR constructs, with intent to help explain how team decisions and actions can contribute to adoption, implementation and maintenance outcomes. Results: Qualitative analysis of team documents and interviews demonstrated strong alignment with the RE-AIM domains: Reach, Effectiveness, and Implementation; and with the CFIR constructs: formal inclusion of provider and staff stakeholders in implementation planning, compatibility of the intervention with workflows and systems, and alignment of the intervention with organizational culture. Focus on these factors likely contributed to RE-AIM outcomes of high implementation fidelity. However, team members expressed low confidence that Breathewell would be adopted and maintained post-trial. A potential explanation was weak alignment with several CFIR constructs, including tension for change, relative priority, and leadership engagement that contribute to organizational receptivity and motivation to sustain change. Conclusions: While RE-AIM provides a practical framework for planning and evaluating practice change interventions to assure their external validity, CFIR explains why implementation succeeded or failed, and when used proactively, identifies relevant modifiable factors that can promote or undermine adoption, implementation, and maintenance.Ye

Changes in antidepressant use by young people and suicidal behavior after FDA warnings and media coverage: quasi-experimental study

Objective To investigate if the widely publicized warnings in 2003 from the US Food and Drug Administration about a possible increased risk of suicidality with antidepressant use in young people were associated with changes in antidepressant use, suicide attempts, and completed suicides among young people. Design Quasi-experimental study assessing changes in outcomes after the warnings, controlling for pre-existing trends. Setting Automated healthcare claims data (2000-10) derived from the virtual data warehouse of 11 health plans in the US Mental Health Research Network. Participants Study cohorts included adolescents (around 1.1 million), young adults (around 1.4 million), and adults (around 5 million). Main outcome measures Rates of antidepressant dispensings, psychotropic drug poisonings (a validated proxy for suicide attempts), and completed suicides. Results Trends in antidepressant use and poisonings changed abruptly after the warnings. In the second year after the warnings, relative changes in antidepressant use were −31.0% (95% confidence interval −33.0% to −29.0%) among adolescents, −24.3% (−25.4% to −23.2%) among young adults, and −14.5% (−16.0% to −12.9%) among adults. These reflected absolute reductions of 696, 1216, and 1621 dispensings per 100 000 people among adolescents, young adults, and adults, respectively. Simultaneously, there were significant, relative increases in psychotropic drug poisonings in adolescents (21.7%, 95% confidence interval 4.9% to 38.5%) and young adults (33.7%, 26.9% to 40.4%) but not among adults (5.2%, −6.5% to 16.9%). These reflected absolute increases of 2 and 4 poisonings per 100 000 people among adolescents and young adults, respectively (approximately 77 additional poisonings in our cohort of 2.5 million young people). Completed suicides did not change for any age group. Conclusions Safety warnings about antidepressants and widespread media coverage decreased antidepressant use, and there were simultaneous increases in suicide attempts among young people. It is essential to monitor and reduce possible unintended consequences of FDA warnings and media reporting

Can digital communication technology reduce health system personnel time? An evaluation of personnel requirements and costs in a randomized controlled trial

Use of digital communication technologies (DCT) shows promise for enhancing outcomes and efficiencies in asthma care management. However, little is known about the impact of DCT interventions on healthcare personnel requirements and costs, thus making it difficult for providers and health systems to understand the value of these interventions. This study evaluated the differences in healthcare personnel requirements and costs between usual asthma care (UC) and a DCT intervention (Breathewell) aimed at maintaining guidelines-based asthma care while reducing health care staffing requirements. We used data from a pragmatic, randomized controlled trial conducted in a large integrated health system involving 14,978 patients diagnosed with asthma. To evaluate differences in staffing requirements and cost between Breathewell and UC needed to deliver guideline-based care we used electronic health record (EHR) events, provider time tracking surveys, and invoicing. Differences in cost were reported at the patient and health system level. The Breathewell intervention significantly reduced personnel requirements with a larger percentage of participants requiring no personnel time (45% vs. 5%, p < .001) and smaller percentage of participants requiring follow-up outreach (44% vs. 68%, p < .001). Extrapolated to the total health system, cost for the Breathewell intervention was $16,278 less than usual care. The intervention became cost savings at a sample size of at least 957 patients diagnosed with asthma. At the population level, using DCT to compliment current asthma care practice presents an opportunity to reduce healthcare personnel requirements while maintaining population-based asthma control measures.Ye

Computerized clinical decision support systems for drug prescribing and management: A decision-maker-researcher partnership systematic review

<p>Abstract</p> <p>Background</p> <p>Computerized clinical decision support systems (CCDSSs) for drug therapy management are designed to promote safe and effective medication use. Evidence documenting the effectiveness of CCDSSs for improving drug therapy is necessary for informed adoption decisions. The objective of this review was to systematically review randomized controlled trials assessing the effects of CCDSSs for drug therapy management on process of care and patient outcomes. We also sought to identify system and study characteristics that predicted benefit.</p> <p>Methods</p> <p>We conducted a decision-maker-researcher partnership systematic review. We updated our earlier reviews (1998, 2005) by searching MEDLINE, EMBASE, EBM Reviews, Inspec, and other databases, and consulting reference lists through January 2010. Authors of 82% of included studies confirmed or supplemented extracted data. We included only randomized controlled trials that evaluated the effect on process of care or patient outcomes of a CCDSS for drug therapy management compared to care provided without a CCDSS. A study was considered to have a positive effect (<it>i.e.</it>, CCDSS showed improvement) if at least 50% of the relevant study outcomes were statistically significantly positive.</p> <p>Results</p> <p>Sixty-five studies met our inclusion criteria, including 41 new studies since our previous review. Methodological quality was generally high and unchanged with time. CCDSSs improved process of care performance in 37 of the 59 studies assessing this type of outcome (64%, 57% of all studies). Twenty-nine trials assessed patient outcomes, of which six trials (21%, 9% of all trials) reported improvements.</p> <p>Conclusions</p> <p>CCDSSs inconsistently improved process of care measures and seldomly improved patient outcomes. Lack of clear patient benefit and lack of data on harms and costs preclude a recommendation to adopt CCDSSs for drug therapy management.</p

Quality of anticoagulation and use of warfarin-interacting medications in long-term care: A chart review

<p>Abstract</p> <p>Background</p> <p>Maintenance of therapeutic International Normalized Ratio (INR) in the community is generally poor. The supervised environment in long-term care facilities may represent a more ideal setting for warfarin therapy since laboratory monitoring, compliance, dose adjustment, and interacting medications can all be monitored and controlled. The objectives of this study were to determine how effectively warfarin was administered to a cohort of residents in long-term care facilities, to identify the proportion of residents prescribed warfarin-interacting drugs and to ascertain factors associated with poor INR control.</p> <p>Methods</p> <p>A chart review of 105 residents receiving warfarin therapy in five long-term care facilities in Hamilton, Ontario was performed. Data were collected on INR levels, warfarin prescribing and monitoring practices, and use of interacting medications.</p> <p>Results</p> <p>Over a 12 month period (28,555 resident-days, 78.2 resident years) 3065 INR values were available. Residents were within, below and above the therapeutic range 54%, 35% and 11% of the time, respectively. Seventy-nine percent of residents were prescribed at least one warfarin-interacting medication during the period in review. Residents receiving interacting medications spent less time in the therapeutic range (53.0% vs. 58.2%, OR = 0.93, 95% confidence interval 0.88 to 0.97, P = 0.002). Adequacy of anticoagulation varied significantly between physicians (time in therapeutic range 45.9 to 63.9%).</p> <p>Conclusion</p> <p>In this group of long-term care residents, warfarin control was suboptimal. Both prescriber and co-prescription of interacting medications were associated with poorer INR control. Future studies should seek strategies to improve prescriber skill and decrease use of interacting medications.</p

When is the Best Time to Sample Aquatic Macroinvertebrates in Ponds for Biodiversity Assessment?

Ponds are sites of high biodiversity and conservation value, yet there is little or no statutory monitoring of them across most of Europe. There are clear and standardized protocols for sampling aquatic macroinvertebrate communities in ponds but the most suitable time(s) to undertake the survey(s) remains poorly specified. This paper examined the aquatic macroinvertebrate communities from 95 ponds within different landuse types over three seasons (spring, summer and autumn) to determine the most appropriate time to undertake sampling to characterise biodiversity. The combined samples from all three seasons provided the most comprehensive record of the aquatic macroinvertebrate taxa recorded within ponds (alpha and gamma diversity). Samples collected during the autumn survey yielded significantly greater macroinvertebrate richness (76% of the total diversity) than either spring or summer surveys. Macroinvertebrate diversity was greatest during autumn in meadow and agricultural ponds but taxon richness among forest and urban ponds did not differ significantly temporally. The autumn survey provided the highest measures of richness for Coleoptera, Hemiptera and Odonata. However, richness of the aquatic insect order Trichoptera was highest in spring and lowest in autumn. The results illustrate that multiple surveys, covering more than one season, provide the most comprehensive representation of macroinvertebrate biodiversity. When sampling can only be undertaken on one occasion, the most appropriate time to undertake surveys to characterise the macroinvertebrate community biodiversity is during the autumn; although this may need to be modified if other floral and faunal groups need to be incorporated in to the sampling programme