Background: Major gaps exist in the routine initiation and dose up-titration of guideline-directed medical therapies (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF). Without novel approaches to improve prescribing, the cumulative benefits of HFrEF treatment will be largely unrealized. Direct-to-consumer marketing and shared decision making reflect a culture where patients are increasingly involved in treatment choices, creating opportunities for prescribing interventions that engage patients. Methods: The Electronically delivered, Patient-activation tool for Intensification of medications for Chronic Heart Failure with reduced ejection fraction (EPIC-HF) trial randomized patients with HFrEF from a diverse health system to usual care versus patient-activation tools—a 3-minute video and 1-page checklist—delivered electronically 1 week prior, 3 days prior and 24 hours prior to a cardiology clinic visit. The tools encouraged patients to work collaboratively with their clinicians to "make one positive change" in HFrEF prescribing. The primary endpoint was the percent of patients with GDMT medication initiations and dose intensifications from immediately preceding the cardiology clinic visit to 30 days, compared to usual care during the same period. Results: EPIC-HF enrolled 306 patients, 290 of whom attended a clinic visit during the study period: 145 were sent the patient-activation tools and 145 were controls. Median age was 65 years, 29% female, 11% black, 7% Hispanic, median ejection fraction 32%. Pre-clinic data revealed significant GDMT opportunities, with no patients on target doses of beta-blocker, sacubitril/valsartan, and mineralocorticoid receptor antagonists. From immediately preceding the cardiology clinic visit to 30 days later, 49.0% in the intervention and 29.7% in control experienced an initiation or intensification of their GDMT (p=0.001). The majority of these changes were made at the clinician encounter itself and involved dose uptitrations. There were no deaths, and no significant differences in hospitalization or emergency department visits at 30 days between groups. Conclusions: A patient-activation tool delivered electronically prior to a cardiology clinic visit improved clinician intensification of GDMT. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT03334188
PHEN/TPM is a new, once-daily, controlled-release, combination weight-loss product approved as an adjunct to diet and exercise for chronic weight management of obese or overweight patients with weight-related comorbidities. PHEN/TPM is modestly effective and a viable option for patients interested in losing weight, although long-term safety data are lacking.
Background: Irritable bowel syndrome (IBS) is a complex syndrome that is difficult to manage. Here we present the evidence supporting medication treatments for specific IBS symptoms, discuss evidence-based management of IBS with medications including dose regimens and adverse effects and review progress on research for new IBS treatments. Summary: Currently, there is evidence to support improvements in specific IBS symptoms following treatment with loperamide, psyllium, bran, lubiprostone, linaclotide, amitriptyline, trimipramine, desipramine, citalopram, fluoxetine, paroxetine, dicyclomine, peppermint oil, rifaximin, ketotifen, pregabalin, gabapentin and octreotide and there are many new medications being investigated for the treatment of IBS. Key Message: Of the medications with demonstrated improvements for IBS symptoms, rifaximin, lubiprostone, linaclotide, fiber supplementation and peppermint oil have the most reliable evidence supporting their use for the treatment of IBS. Onset of efficacy for the various medications has been noted to be as early as 6 days after initiation; however, the efficacy of most medications was not assessed prospectively at predefined periods. Additional studies of currently available and new medications are ongoing and are needed to better define their place in therapy and expand therapeutic options for the treatment of IBS. The most promising new medications for IBS include a variety of novel pharmacologic approaches, most notably the dual μ-opioid receptor agonist and δ-opioid antagonist, JNJ-27018966.
BackgroundTo improve user-centred design efforts and efficiency; there is a need to disseminate information on modern day clinician preferences for technologies such as computerised clinical decision support (CDS).ObjectiveTo describe clinician perceptions regarding beneficial features of CDS for chronic medications in primary care.MethodsThis study included focus groups and clinicians individually describing their ideal CDS. Three focus groups were conducted including prescribing clinicians from a variety of disciplines. Outcome measures included identification of favourable features and unintended consequences of CDS for chronic medication management in primary care. We transcribed recordings, performed thematic qualitative analysis and generated counts when possible.ResultsThere were 21 participants who identified four categories of beneficial CDS features during the group discussion: non-interruptive alerts, clinically relevant and customisable support, presentation of pertinent clinical information and optimises workflow. Non-interruptive alerts were broadly defined as passive alerts that a user chooses to review, whereas interruptive were active or disruptive alerts that interrupted workflow and one is forced to review before completing a task. The CDS features identified in the individual descriptions were consistent with the focus group discussion, with the exception of non-interruptive alerts. In the individual descriptions, 12 clinicians preferred interruptive CDS compared with seven clinicians describing non-interruptive CDS.ConclusionClinicians identified CDS for chronic medications beneficial when they are clinically relevant and customisable, present pertinent clinical information (eg, labs, vitals) and improve their workflow. Although clinicians preferred passive, non-interruptive alerts, most acknowledged that these may not be widely seen and may be less effective. These features align with literature describing best practices in CDS design and emphasise those features clinicians prioritise, which should be considered when designing CDS for medication management in primary care. These findings highlight the disparity between the current state of CDS design and clinician-stated design features associated with beneficial CDS.
Background Clinical decision support (CDS) design best practices are intended to provide a narrative representation of factors that influence the success of CDS tools. However, they provide incomplete direction on evidence-based implementation principles. Objective This study aims to describe an integrated approach toward applying an existing implementation science (IS) framework with CDS design best practices to improve the effectiveness, sustainability, and reproducibility of CDS implementations. Methods We selected the Practical Robust Implementation and Sustainability Model (PRISM) IS framework. We identified areas where PRISM and CDS design best practices complemented each other and defined methods to address each. Lessons learned from applying these methods were then used to further refine the integrated approach. Results Our integrated approach to applying PRISM with CDS design best practices consists of 5 key phases that iteratively interact and inform each other: multilevel stakeholder engagement, designing the CDS, design and usability testing, thoughtful deployment, and performance evaluation and maintenance. The approach is led by a dedicated implementation team that includes clinical informatics and analyst builder expertise. Conclusions Integrating PRISM with CDS design best practices extends user-centered design and accounts for the multilevel, interacting, and dynamic factors that influence CDS implementation in health care. Integrating PRISM with CDS design best practices synthesizes the many known contextual factors that can influence the success of CDS tools, thereby enhancing the reproducibility and sustainability of CDS implementations. Others can adapt this approach to their situation to maximize and sustain CDS implementation success.
In recent years, the genomics community has witnessed the growth of large research biobanks, which collect DNA samples for research purposes. Depending on how and where the samples are genotyped, biobanks also offer the potential opportunity to return actionable genomic results to the clinical setting. We developed a preemptive clinical pharmacogenomic implementation initiative via a health system-wide research biobank at the University of Colorado. Here, we describe how preemptive return of clinical pharmacogenomic results via a research biobank is feasible, particularly when coupled with strong institutional support to maximize the impact and efficiency of biobank resources, a multidisciplinary implementation team, automated clinical decision support tools, and proactive strategies to engage stakeholders early in the clinical decision support tool development process.
Summary What is known and Objective: The complexity and diversity of irritable bowel syndrome’s (IBS) presentation make treatment difficult. Although there are reviews and guidelines for treating IBS, they focus on the efficacy of medications for IBS symptoms using high‐priority endpoints, leaving those of lower priority largely unreported. Therefore, the aim of this review is to provide a comprehensive evidence‐based review of the efficacy of medications to treat IBS symptoms, reported by IBS subtype, including secondary symptom endpoints that are often underreported. Methods: A review of PubMed for articles published through December 2009 using the keywords: ‘irritable bowel syndrome’, ‘therapeutics’, ‘antidiarrhoeals’, ‘laxatives’, ‘loperamide’, ‘dietary fibre’, ‘psyllium’, ‘calcium polycarbophil’, ‘bulking agents’, ‘lubiprostone’, ‘antidepressant agents, tricyclics’ and its representative entities, ‘serotonin reuptake inhibitors’ and its representative entities, ‘dicyclomine’, hyoscyamine’, ‘peppermint oil’, ‘parasympatholytics’ and its representative entities, ‘rifaximin’, ‘pregabalin’, ‘gabapentin’, ‘clonidine’, ‘octreotide’, ‘atropine’ and ‘probiotics’ is provided. Placebo‐controlled trials were evaluated for the strength of evidence supporting the efficacy of each medication for explicit IBS symptoms. The efficacy of each medication for the symptoms of abdominal pain, bloating, stool form, mucus, urgency, feeling of incomplete evacuation, flatulence, frequency, or borborgymi and overall symptoms are reported by IBS subtype. Results and Discussion: The literature search identified 58 placebo‐controlled trials of the efficacy of medications for treating IBS symptoms, which were critically evaluated and reported. The available studies suggest improvement in various IBS symptoms with loperamide, fibre supplements, lubiprostone, tricyclic antidepressants (TCAs), selective serotonin receptor inhibitors (SSRIs), antispasmotics, rifaximin, pregabalin, gabapentin, clonidine, octreotide and probiotic treatments. What is new and Conclusion: This review is the first to compile the available evidence on the efficacy of the various pharmacological treatments for IBS on the basis of IBS subtype and specific symptoms. This evidence is limited and more well‐designed studies are required to better inform therapeutic decision‐making in the management of this difficult syndrome.
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