Implementing an innovative consent form: the PREDICT experience

Background

This article describes the process used by the authors in developing an implementation intervention to assist VA substance use disorder clinics in adopting guideline-based practices for treating depression. This article is one in a Series of articles documenting implementation science frameworks and tools developed by the U.S. Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI).

Methods

The process involves two steps: 1) diagnosis of site-specific implementation needs, barriers, and facilitators (i.e., formative evaluation); and 2) the use of multi-disciplinary teams of local staff, implementation experts, and clinical experts to interpret diagnostic data and develop site-specific interventions. In the current project, data were collected via observations of program activities and key informant interviews with clinic staff and patients. The assessment investigated a wide range of macro- and micro-level determinants of organizational and provider behavior.

Conclusion

The implementation development process described here is presented as an optional method (or series of steps) to consider when designing a small scale, multi-site implementation study. The process grew from an evidence-based quality improvement strategy developed for – and proven efficacious in – primary care settings. The authors are currently studying the efficacy of the process across a spectrum of specialty care treatment settings.     

Tailoring an intervention to the context and system redesign related to the intervention: A case study of implementing shared medical appointments for diabetes

Background

Health care organizations exert significant influence on the manner in which clinicians practice and the processes and outcomes of care that patients experience. A greater understanding of the organizational milieu into which innovations will be introduced, as well as the organizational factors that are likely to foster or hinder the adoption and use of new technologies, care arrangements and quality improvement (QI) strategies are central to the effective implementation of research into practice. Unfortunately, much implementation research seems to not recognize or adequately address the influence and importance of organizations. Using examples from the U.S. Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI), we describe the role of organizational research in advancing the implementation of evidence-based practice into routine care settings.

Methods

Using the six-step QUERI process as a foundation, we present an organizational research framework designed to improve and accelerate the implementation of evidence-based practice into routine care. Specific QUERI-related organizational research applications are reviewed, with discussion of the measures and methods used to apply them. We describe these applications in the context of a continuum of organizational research activities to be conducted before, during and after implementation.

Results

Since QUERI's inception, various approaches to organizational research have been employed to foster progress through QUERI's six-step process. We report on how explicit integration of the evaluation of organizational factors into QUERI planning has informed the design of more effective care delivery system interventions and enabled their improved "fit" to individual VA facilities or practices. We examine the value and challenges in conducting organizational research, and briefly describe the contributions of organizational theory and environmental context to the research framework.

Conclusion

Understanding the organizational context of delivering evidence-based practice is a critical adjunct to efforts to systematically improve quality. Given the size and diversity of VA practices, coupled with unique organizational data sources, QUERI is well-positioned to make valuable contributions to the field of implementation science. More explicit accommodation of organizational inquiry into implementation research agendas has helped QUERI researchers to better frame and extend their work as they move toward regional and national spread activities.     

Role of "external facilitation" in implementation of research findings: a qualitative evaluation of facilitation experiences in the Veterans Health Administration

Background

Facilitation has been identified in the literature as a potentially key component of successful implementation. It has not, however, either been well-defined or well-studied. Significant questions remain about the operational definition of facilitation and about the relationship of facilitation to other interventions, especially to other change agent roles when used in multi-faceted implementation projects. Researchers who are part of the Quality Enhancement Research Initiative (QUERI) are actively exploring various approaches and processes, including facilitation, to enable implementation of best practices in the Veterans Health Administration health care system – the largest integrated healthcare system in the United States. This paper describes a systematic, retrospective evaluation of implementation-related facilitation experiences within QUERI, a quality improvement program developed by the US Department of Veterans Affairs.

Methods

A post-hoc evaluation was conducted through a series of semi-structured interviews to examine the concept of facilitation across several multi-site QUERI implementation studies. The interview process is based on a technique developed in the field of education, which systematically enhances learning through experience by stimulating recall and reflection regarding past complex activities. An iterative content analysis approach relative to a set of conceptually-based interview questions was used for data analysis.

Findings

Findings suggest that facilitation, within an implementation study initiated by a central change agency, is a deliberate and valued process of interactive problem solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship. Facilitation was described primarily as a distinct role with a number of potentially crucial behaviors and activities. Data further suggest that external facilitators were likely to use or integrate other implementation interventions, while performing this problem-solving and supportive role.

Preliminary Conclusions

This evaluation provides evidence to suggest that facilitation could be considered a distinct implementation intervention, just as audit and feedback, educational outreach, or similar methods are considered to be discrete interventions. As such, facilitation should be well-defined and explicitly evaluated for its perceived usefulness within multi-intervention implementation projects. Additionally, researchers should better define the specific contribution of facilitation to the success of implementation in different types of projects, different types of sites, and with evidence and innovations of varying levels of strength and complexity.     

Resource utilization and cost-effectiveness of counselor- vs. provider-based rapid point-of-care HIV screening in the emergency department

Background

Routine HIV screening in emergency department (ED) settings may require dedicated personnel. We evaluated the outcomes, costs and cost-effectiveness of HIV screening when offered by either a member of the ED staff or by an HIV counselor.

Methods

We employed a mathematical model to extend data obtained from a randomized clinical trial of provider- vs. counselor-based HIV screening in the ED. We compared the downstream survival, costs, and cost-effectiveness of three HIV screening modalities: 1) no screening program; 2) an ED provider-based program; and 3) an HIV counselor-based program. Trial arm-specific data were used for test offer and acceptance rates (provider offer 36%, acceptance 75%; counselor offer 80%, acceptance 71%). Undiagnosed HIV prevalence (0.4%) and linkage to care rates (80%) were assumed to be equal between the screening modalities. Personnel costs were derived from trial-based resource utilization data. We examined the generalizability of results by conducting sensitivity analyses on offer and acceptance rates, undetected HIV prevalence, and costs.

Results

Estimated HIV screening costs in the provider and counselor arms averaged $8.10 and $31.00 per result received. The Provider strategy (compared to no screening) had an incremental cost-effectiveness ratio of $58,700/quality-adjusted life year (QALY) and the Counselor strategy (compared to the Provider strategy) had an incremental cost-effectiveness ratio of $64,500/QALY. Results were sensitive to the relative offer and acceptance rates by strategy and the capacity of providers to target-screen, but were robust to changes in undiagnosed HIV prevalence and programmatic costs.

Conclusions

The cost-effectiveness of provider-based HIV screening in an emergency department setting compares favorably to other US screening programs. Despite its additional cost, counselor-based screening delivers just as much return on investment as provider based-screening. Investment in dedicated HIV screening personnel is justified in situations where ED staff resources may be insufficient to provide comprehensive, sustainable screening services.     

Ethical issues in implementation research: a discussion of the problems in achieving informed consent

Background

Implementation of research into practice in health care systems is a challenging and often unsuccessful endeavor. The United States Department of Veterans Affairs (VA) Quality Enhancement Research Initiative (QUERI) research teams include formative evaluations (FE) in their action-oriented VA implementation projects to identify critical information about the processes of implementation that can guide adjustments to project activities, in order to better meet project goals. This article describes the development and use of FE in an action-oriented implementation research project.

Methods

This two-year action-oriented implementation research project was conducted at 23 VA Spinal Cord Injury (SCI) Centers, and targeted patients, staff and the system of care, such as administration and information technology. Data for FE were collected by electronic and paper surveys, semi-structured and open-ended interviews, notes during conference calls, and exchange of e-mail messages. Specific questions were developed for each intervention (designed to improve vaccination rates for influenza in veterans with spinal cord injury and disorder); informants were selected for their knowledge of interventions and their use in SCI Centers.

Results

Data from FE were compiled separately for each intervention to describe barriers to progress and guide adjustments to implementation activities. These data addressed the processes of implementing the interventions, problem-solving activities and the status of interventions at SCI Centers.

Conclusion

Formative evaluations provided the project team with a broad view of the processes of implementing multi-targeted interventions as well as the evolving status of the related best practice. Using FE was useful, although the challenges of conducting FE for non-field researchers should be addressed. Work is needed to develop methods for conducting FE across multiple sites, as well as acknowledging variations in local contexts that affect implementation of interventions.     

The effect of a controlled manipulation of maternal dietary fat intake on medium and long chain fatty acids in human breast milk in Saskatoon, Canada

Background

For HIV infected mothers in developing countries, choosing to enroll in a prevention of mother to child transmission (PMTCT) of HIV program is supposed to represent the first step towards protecting their child from possible transmission of HIV from mother to child. Counseling and testing enable HIV infected mothers to learn about their status and to obtain the benefits of a PMTCT package. The study on which this article is based explored experiences of HIV positive women and their partners linked to Prevention of Mother to Child Transmission of HIV (PMTCT) programs in Chiradzulu district, Southern Malawi.

Methods

A qualitative study using in-depth interviews (IDIs), focus group discussion (FGDs) and case studies was carried at two PMTCT sites. IDIs and FGDs were recorded and transcribed. The case studies involved a deeper inquiry into the past, present and situational factors of selected participants.

Results

In a context of customary matrilineal kinship, matrilocal residence patterns and complete male absence from the PMTCT program, the demand by the PMTCT program for partner disclosure played up fears of rejection among men given accusations of infidelity by the wives' relatives. This situation led many men to abandon their families. Mothers enrolled in PMTCT programs hence faced not only the fear of transmitting the virus to their infants, but also the loss of income and support associated with a departed husband and the social disgrace of a ruined family. Community members referred to the PMTCT program as 'the divorce program'

Conclusions

PMTCT programs may vary in effectiveness in different contexts unless they fundamentally respond to socio-cultural factors as lived out in communities they intend to serve. The PMTCT program in rural southern Malawi is a case in point.     

Recodon: Coalescent simulation of coding DNA sequences with recombination, migration and demography

Background

Coalescent simulations have proven very useful in many population genetics studies. In order to arrive to meaningful conclusions, it is important that these simulations resemble the process of molecular evolution as much as possible. To date, no single coalescent program is able to simulate codon sequences sampled from populations with recombination, migration and growth.

Results

We introduce a new coalescent program, called Recodon, which is able to simulate samples of coding DNA sequences under complex scenarios in which several evolutionary forces can interact simultaneously (namely, recombination, migration and demography). The basic codon model implemented is an extension to the general time-reversible model of nucleotide substitution with a proportion of invariable sites and among-site rate variation. In addition, the program implements non-reversible processes and mixtures of different codon models.

Conclusion

Recodon is a flexible tool for the simulation of coding DNA sequences under realistic evolutionary models. These simulations can be used to build parameter distributions for testing evolutionary hypotheses using experimental data. Recodon is written in C, can run in parallel, and is freely available from http://darwin.uvigo.es/.     

The organizational social context of mental health services and clinician attitudes toward evidence-based practice: a United States national study

Background

Collaborative-care management is an evidence-based practice for improving depression outcomes in primary care. The Department of Veterans Affairs (VA) has mandated the implementation of collaborative-care management in its satellite clinics, known as Community Based Outpatient Clinics (CBOCs). However, the organizational characteristics of CBOCs present added challenges to implementation. The objective of this study was to evaluate the effectiveness of evidence-based quality improvement (EBQI) as a strategy to facilitate the adoption of collaborative-care management in CBOCs.

Methods

This nonrandomized, small-scale, multisite evaluation of EBQI was conducted at three VA Medical Centers and 11 of their affiliated CBOCs. The Plan phase of the EBQI process involved the localized tailoring of the collaborative-care management program to each CBOC. Researchers ensured that the adaptations were evidence based. Clinical and administrative staff were responsible for adapting the collaborative-care management program for local needs, priorities, preferences and resources. Plan-Do-Study-Act cycles were used to refine the program over time. The evaluation was based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) Framework and used data from multiple sources: administrative records, web-based decision-support systems, surveys, and key-informant interviews.

Results

Adoption: 69.0% (58/84) of primary care providers referred patients to the program. Reach: 9.0% (298/3,296) of primary care patients diagnosed with depression who were not already receiving specialty care were enrolled in the program. Fidelity: During baseline care manager encounters, education/activation was provided to 100% (298/298) of patients, barriers were assessed and addressed for 100% (298/298) of patients, and depression severity was monitored for 100% (298/298) of patients. Less than half (42.5%, 681/1603) of follow-up encounters during the acute stage were completed within the timeframe specified. During the acute phase of treatment for all trials, the Patient Health Questionnaire (PHQ9) symptom-monitoring tool was used at 100% (681/681) of completed follow-up encounters, and self-management goals were discussed during 15.3% (104/681) of completed follow-up encounters. During the acute phase of treatment for pharmacotherapy and combination trials, medication adherence was assessed at 99.1% (575/580) of completed follow-up encounters, and side effects were assessed at 92.4% (536/580) of completed follow-up encounters. During the acute phase of treatment for psychotherapy and combination trials, counseling session adherence was assessed at 83.3% (239/287) of completed follow-up encounters. Effectiveness: 18.8% (56/298) of enrolled patients remitted (symptom free) and another 22.1% (66/298) responded to treatment (50% reduction in symptom severity). Maintenance: 91.9% (10/11) of the CBOCs chose to sustain the program after research funds were withdrawn.

Conclusions

Provider adoption was good, although reach into the target population was relatively low. Fidelity and maintenance were excellent, and clinical outcomes were comparable to those in randomized controlled trials. Despite the organizational barriers, these findings suggest that EBQI is an effective facilitation strategy for CBOCs.

Trial registration

Clinical trial # NCT00317018.     

Development and prospective validation of a model for predicting weaning in chronic ventilator dependent patients

Background

HTLV-I infection has been linked to lung pathology and HTLV-II has been associated with an increased incidence of pneumonia and acute bronchitis. However it is unknown whether HTLV-I or -II infection alters pulmonary function.

Methods

We performed pulmonary function testing on HTLV-I, HTLV-II and HTLV seronegative subjects from the HTLV outcomes study (HOST), including vital capacity (VC), forced expiratory volume in one second (FEV₁), and diffusing lung capacity for carbon monoxide (DLCO) corrected for hemoglobin and lung volume. Multivariable analysis adjusted for differences in age, gender, race/ethnicity, height and smoking history.

Results

Mean (standard deviation) pulmonary function values among the 257 subjects were as follows: FVC = 3.74 (0.89) L, FEV₁ = 2.93 (0.67) L, DLCO_corr = 23.82 (5.89) ml/min/mmHg, alveolar ventilation (VA) = 5.25 (1.20) L and DLCO_corr/VA = 4.54 (0.87) ml/min/mmHg/L. There were no differences in FVC, FEV1 and DLCO_corr/VA by HTLV status. For DLCO_corr, HTLV-I and HTLV-II subjects had slightly lower values than seronegatives, but neither difference was statistically significant after adjustment for confounding.

Conclusions

There was no difference in measured pulmonary function and diffusing capacity in generally healthy HTLV-I and HTLV-II subjects compared to seronegatives. These results suggest that previously described HTLV-associated abnormalities in bronchoalveolar cells and fluid may not affect pulmonary function.     

Azelnidipine prevents cardiac dysfunction in streptozotocin-diabetic rats by reducing intracellular calcium accumulation, oxidative stress and apoptosis

Background

In the general population, peripheral metabolic complications (MC) increase the risk for left ventricular dysfunction. Human immunodeficiency virus infection (HIV) and combination anti-retroviral therapy (cART) are associated with MC, left ventricular dysfunction, and a higher incidence of cardiovascular events than the general population. We examined whether myocardial nutrient metabolism and left ventricular dysfunction are related to one another and worse in HIV infected men treated with cART vs. HIV-negative men with or without MC.

Methods

Prospective, cross-sectional study of myocardial glucose and fatty acid metabolism and left ventricular function in HIV+ and HIV-negative men with and without MC. Myocardial glucose utilization (GLUT), and fatty acid oxidation and utilization rates were quantified using ¹¹C-glucose and ¹¹C-palmitate and myocardial positron emission tomography (PET) imaging in four groups of men: 23 HIV+ men with MC+ (HIV+/MC+, 42 ± 6 yrs), 15 HIV+ men without MC (HIV+/MC-, 41 ± 6 yrs), 9 HIV-negative men with MC (HIV-/MC+, 33 ± 5 yrs), and 22 HIV-negative men without MC (HIV-/MC-, 25 ± 6 yrs). Left ventricular function parameters were quantified using echocardiography.

Results

Myocardial glucose utilization was similar among groups, however when normalized to fasting plasma insulin concentration (GLUT/INS) was lower (p < 0.01) in men with metabolic complications (HIV+: 9.2 ± 6.2 vs. HIV-: 10.4 ± 8.1 nmol/g/min/μU/mL) than men without metabolic complications (HIV+: 45.0 ± 33.3 vs. HIV-: 60.3 ± 53.0 nmol/g/min/μU/mL). Lower GLUT/INS was associated with lower myocardial relaxation velocity during early diastole (r = 0.39, p < 0.001).

Conclusion

Men with metabolic complications, irrespective of HIV infection, had lower basal myocardial glucose utilization rates per unit insulin that were related to left ventricular diastolic impairments, indicating that well-controlled HIV infection is not an independent risk factor for blunted myocardial glucose utilization per unit of insulin.

Trial Registration

NIH Clinical Trials NCT00656851     

HIV infection of thymocytes inhibits IL-7 activity without altering CD127 expression

Background

Thymic function is altered in HIV infection and characterized by dysregulation of the thymic epithelial network, reduced thymic output and ultimately an impaired naïve T-cell pool. The IL-7/IL-7 receptor (IL-7R) signalling pathway is critical for the maturation and differentiation of thymocytes. HIV infection is associated with a decrease in IL-7Rα (CD127) expression and impaired CD127 signalling in circulating CD8⁺ T-cells; however, little is known about the effect of HIV on CD127 expression and IL-7 activity in the thymus. Therefore, the effect of in vitro HIV infection on CD127 expression and IL-7-mediated function in thymocytes was investigated.

Findings

In vitro HIV infection of thymocytes did not affect CD127 expression on either total thymocytes or on single positive CD4 or single positive CD8 subsets. However, HIV infection resulted in a decrease in the level of IL-7-induced STAT-5 phosphorylation and Bcl-2 expression in unfractionated thymocytes.

Conclusion

These findings indicate that HIV infection alters IL-7 responsiveness of thymocytes by a mechanism other than CD127 downregulation and potentially explain the disruption in thymopoiesis observed in HIV infection.     

Primary antibiotic resistance and associated mechanisms in Helicobacter pylori isolates from Senegalese patients

Background

Antibiotic combination therapy for Helicobacter pylori eradication must be adapted to local resistance patterns, but the epidemiology of H. pylori resistance to antibiotics is poorly documented in Africa. The aim was to determine the antibiotic resistance rates, as well as the associated molecular mechanisms, of strains isolated in Dakar, Senegal.

Methods

One hundred and eight H. pylori strains were isolated between 2007 and 2009 from 108 patients presenting with upper abdominal pain to the Gastroenterology Department of Le Dantec Hospital. Antimicrobial susceptibility testing was performed for amoxicillin, clarithromycin, metronidazole, levofloxacin and tetracyclin using the E-test method. Mutations in the 23S rRNA gene of clarithromycin-resistant strains and in gyrA and gyrB of levofloxacin-resistant strains were investigated.

Results

Isolates were characterized by no resistance to amoxicillin (0%), tetracycline (0%), and very low rate of resistance to clarithromycin (1%), but a high rate of resistance to metronidazole (85%). The clarithromycin-resistant strain displayed the A2143G mutation. A worrying rate of levofloxacin resistance was detected (15%). N87I and D91N were the most common mutations in the quinolone-resistance-determining region of gyrA.

Conclusions

The first-line empirical regimen for H. pylori eradication in Senegal should include clarithromycin. Increasing rates of fluoroquinolone resistance detected should discourage the use of levofloxacin-containing regimens without prior antimicrobial susceptibility testing.     

Individual patient data meta-analysis of acupuncture for chronic pain: protocol of the Acupuncture Trialists' Collaboration

Objectives

To evaluate the use and reporting of adjusted analysis in randomised controlled trials (RCTs) and compare the quality of reporting before and after the revision of the CONSORT Statement in 2001.

Design

Comparison of two cross sectional samples of published articles.

Data Sources

Journal articles indexed on PubMed in December 2000 and December 2006.

Study Selection

Parallel group RCTs with a full publication carried out in humans and published in English

Main outcome measures

Proportion of articles reported adjusted analysis; use of adjusted analysis; the reason for adjustment; the method of adjustment and the reporting of adjusted analysis results in the main text and abstract.

Results

In both cohorts, 25% of studies reported adjusted analysis (84/355 in 2000 vs 113/422 in 2006). Compared with articles reporting only unadjusted analyses, articles that reported adjusted analyses were more likely to specify primary outcomes, involve multiple centers, perform stratified randomization, be published in general medical journals, and recruit larger sample sizes. In both years a minority of articles explained why and how covariates were selected for adjustment (20% to 30%). Almost all articles specified the statistical methods used for adjustment (99% in 2000 vs 100% in 2006) but only 5% and 10%, respectively, reported both adjusted and unadjusted results as recommended in the CONSORT guidelines.

Conclusion

There was no evidence of change in the reporting of adjusted analysis results five years after the revision of the CONSORT Statement and only a few articles adhered fully to the CONSORT recommendations.     

Quantification of the virus-host interaction in human T lymphotropic virus I infection

Background

Cellular infection with human immunodeficiency virus (HIV) both in vitro and in vivo requires a member of the chemokine receptor family to act as a co-receptor for viral entry. However, it is presently unclear to what extent the interaction of HIV proteins with chemokine receptors generates intracellular signals that are important for productive infection.

Results

In this study we have used a recently described family of chemokine inhibitors, termed BSCIs, which specifically block chemokine-induced chemotaxis without affecting chemokine ligands binding to their receptors. The BSCI termed Peptide 3 strongly inhibited CCR5 mediated HIV infection of THP-1 cells (83 ± 7% inhibition assayed by immunofluoresence staining), but had no effect on gp120 binding to CCR5. Peptide 3 did not affect CXCR4-dependent infection of Jurkat T cells.

Conclusion

These observations suggest that, in some cases, intracellular signals generated by the chemokine coreceptor may be required for a productive HIV infection.     

ETB receptor polymorphism is associated with airway obstruction

Background

Cardiopulmonary exercise testing (CPET) has become an important modality for the evaluation and management of patients with a diverse array of medical problems. However, interpreting these tests is often difficult and time consuming, requiring significant expertise.

Methods

We created a computer software program (XINT) that assists in CPET interpretation. The program uses an integrative approach as recommended in the Official Statement of the American Thoracic Society/American College of Chest Physicians (ATS/ACCP) on Cardiopulmonary Exercise Testing. In this paper we discuss the principles behind the software. We also provide the detailed logic in an accompanying file (Additional File 1). The actual program and the open source code are also available free over the Internet at http://www.xint.org. For convenience, the required download files can also be accessed from this article.

Results

To test the clinical usefulness of XINT, we present the computer generated interpretations of the case studies discussed in the ATS/ACCP document in another accompanying file (Additional File 2). We believe the interpretations are consistent with the document's criteria and the interpretations given by the expert panel.

Conclusion

Computers have become an integral part of modern life. Peer-reviewed scientific journals are now able to present not just medical concepts and experimental studies, but actual functioning medical interpretive software. This has enormous potential to improve medical diagnoses and patient care. We believe XINT is such a program that will give clinically useful interpretations when used by the medical community at large.     

Morphological and growth altering effects of Cisplatin in C. albicans using fluorescence microscopy

Background

Extrapulmonary manifestations of tuberculosis have become increasingly important in the era of HIV/AIDS.

Case presentation

We describe a case of tuberculosis (TB) dactylitis in a patient with AIDS who originated from the Ivory Coast. The diagnosis was established by direct visualization of acid-fast bacilli on joint fluid and bone biopsy of the proximal phalanx. Imaging of the chest revealed multiple bilateral nodules. Confirmation of the diagnosis was made by isolation of Mycobacterium tuberculosis from sputum and bone cultures.

Conclusion

Tuberculosis should be considered in patients with unusual soft tissue or skeletal lesions, especially when an immunosuppressive condition is present. Ziehl-Neelsen staining and culture of tissue obtained via surgical biopsy offer the most direct approach to diagnosis.     

Improved analysis of bacterial CGH data beyond the log-ratio paradigm

Background

While the theory of enzyme kinetics is fundamental to analyzing and simulating biochemical systems, the derivation of rate equations for complex mechanisms for enzyme-catalyzed reactions is cumbersome and error prone. Therefore, a number of algorithms and related computer programs have been developed to assist in such derivations. Yet although a number of algorithms, programs, and software packages are reported in the literature, one or more significant limitation is associated with each of these tools. Furthermore, none is freely available for download and use by the community.

Results

We have implemented an algorithm based on the schematic method of King and Altman (KA) that employs the topological theory of linear graphs for systematic generation of valid reaction patterns in a GUI-based stand-alone computer program called KAPattern. The underlying algorithm allows for the assumption steady-state, rapid equilibrium-binding, and/or irreversibility for individual steps in catalytic mechanisms. The program can automatically generate MathML and MATLAB output files that users can easily incorporate into simulation programs.

Conclusion

A computer program, called KAPattern, for generating rate equations for complex enzyme system is a freely available and can be accessed at http://www.biocoda.org.     

A Guide for applying a revised version of the PARIHS framework for implementation

Background

Clinical prediction rules (CPRs) represent well-validated but underutilized evidence-based medicine tools at the point-of-care. To date, an inability to integrate these rules into an electronic health record (EHR) has been a major limitation and we are not aware of a study demonstrating the use of CPR's in an ambulatory EHR setting. The integrated clinical prediction rule (iCPR) trial integrates two CPR's in an EHR and assesses both the usability and the effect on evidence-based practice in the primary care setting.

Methods

A multi-disciplinary design team was assembled to develop a prototype iCPR for validated streptococcal pharyngitis and bacterial pneumonia CPRs. The iCPR tool was built as an active Clinical Decision Support (CDS) tool that can be triggered by user action during typical workflow. Using the EHR CDS toolkit, the iCPR risk score calculator was linked to tailored ordered sets, documentation, and patient instructions. The team subsequently conducted two levels of 'real world' usability testing with eight providers per group. Usability data were used to refine and create a production tool. Participating primary care providers (n = 149) were randomized and intervention providers were trained in the use of the new iCPR tool. Rates of iCPR tool triggering in the intervention and control (simulated) groups are monitored and subsequent use of the various components of the iCPR tool among intervention encounters is also tracked. The primary outcome is the difference in antibiotic prescribing rates (strep and pneumonia iCPR's encounters) and chest x-rays (pneumonia iCPR only) between intervention and control providers.

Discussion

Using iterative usability testing and development paired with provider training, the iCPR CDS tool leverages user-centered design principles to overcome pervasive underutilization of EBM and support evidence-based practice at the point-of-care. The ongoing trial will determine if this collaborative process will lead to higher rates of utilization and EBM guided use of antibiotics and chest x-ray's in primary care.

Trial Registration

ClinicalTrials.gov Identifier NCT01386047