2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group.

The 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program Coordinating Committee Expert Panel Working Group was coordinated and supported by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. It is designed to improve patient care and support informed decision making about asthma management in the clinical setting. This update addresses six priority topic areas as determined by the state of the science at the time of a needs assessment, and input from multiple stakeholders:A rigorous process was undertaken to develop these evidence-based guidelines. The Agency for Healthcare Research and Quality's (AHRQ) Evidence-Based Practice Centers conducted systematic reviews on these topics, which were used by the Expert Panel Working Group as a basis for developing recommendations and guidance. The Expert Panel used GRADE (Grading of Recommendations, Assessment, Development and Evaluation), an internationally accepted framework, in consultation with an experienced methodology team for determining the certainty of evidence and the direction and strength of recommendations based on the evidence. Practical implementation guidance for each recommendation incorporates findings from NHLBI-led patient, caregiver, and clinician focus groups. To assist clincians in implementing these recommendations into patient care, the new recommendations have been integrated into the existing Expert Panel Report-3 (EPR-3) asthma management step diagram format.

2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapy.

A panel of experts was convened by the Infectious Diseases Society of America (IDSA) to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare professionals who prescribe and oversee the provision of OPAT. It considers various patient features, infusion catheter issues, monitoring questions, and antimicrobial stewardship concerns. It does not offer recommendations on the treatment of specific infections. The reader is referred to disease- or organism-specific guidelines for such support.

2018 Infectious Diseases Society of America Clinical Practice Guideline for the Management of Outpatient Parenteral Antimicrobial Therapy.

A panel of experts was convened by the Infectious Diseases Society of America to update the 2004 clinical practice guideline on outpatient parenteral antimicrobial therapy (OPAT) [1]. This guideline is intended to provide insight for healthcare professionals who prescribe and oversee the provision of OPAT. It considers various patient features, infusion catheter issues, monitoring questions, and antimicrobial stewardship concerns. It does not offer recommendations on the treatment of specific infections. The reader is referred to disease- or organism-specific guidelines for such support.

Determining the Association Between End-of-Life Care Resources and Patient Outcomes in Pennsylvania ICUs.

OBJECTIVES: As ICUs are increasingly a site of end-of-life care, many have adopted end-of-life care resources. We sought to determine the association of such resources with outcomes of ICU patients. DESIGN: Retrospective cohort study. SETTING: Pennsylvania ICUs. PATIENTS: Medicare fee-for-service beneficiaries. INTERVENTIONS: Availability of any of one hospital-based resource (palliative care consultants) or four ICU-based resources (protocol for withdrawal of life-sustaining therapy, triggers for automated palliative care consultation, protocol for family meetings, and palliative care clinicians embedded in ICU rounds). MEASUREMENTS AND MAIN RESULTS: In mixed-effects regression analyses, admission to a hospital with end-of-life resources was not associated with mortality, length of stay, or treatment intensity (mechanical ventilation, hemodialysis, tracheostomy, gastrostomy, artificial nutrition, or cardiopulmonary resuscitation); however, it was associated with a higher likelihood of discharge to hospice (odds ratio, 1.58; 95% CI, 1.11-2.24), an effect that was driven by ICU-based resources (odds ratio, 1.37; 95% CI, 1.04-1.81) rather than hospital-based resources (odds ratio, 1.19; 95% CI, 0.83-1.71). Instrumental variable analysis using differential distance (defined as the additional travel distance beyond the hospital closest to a patient's home needed to reach a hospital with end-of-life resources) demonstrated that among those for whom differential distance would influence receipt of end-of-life resources, admission to a hospital with such resources was not associated with any outcome. CONCLUSIONS: ICU-based end-of-life care resources do not appear to change mortality but are associated with increased hospice utilization. Given that this finding was not confirmed by the instrumental variable analysis, future studies should attempt to verify this finding, and identify specific resources or processes of care that impact the care of ICU patients at the end of life.

Clinician Perception of a Machine Learning-Based Early Warning System Designed to Predict Severe Sepsis and Septic Shock.

OBJECTIVE: To assess clinician perceptions of a machine learning-based early warning system to predict severe sepsis and septic shock (Early Warning System 2.0). DESIGN: Prospective observational study. SETTING: Tertiary teaching hospital in Philadelphia, PA. PATIENTS: Non-ICU admissions November-December 2016. INTERVENTIONS: During a 6-week study period conducted 5 months after Early Warning System 2.0 alert implementation, nurses and providers were surveyed twice about their perceptions of the alert's helpfulness and impact on care, first within 6 hours of the alert, and again 48 hours after the alert. MEASUREMENTS AND MAIN RESULTS: For the 362 alerts triggered, 180 nurses (50% response rate) and 107 providers (30% response rate) completed the first survey. Of these, 43 nurses (24% response rate) and 44 providers (41% response rate) completed the second survey. Few (24% nurses, 13% providers) identified new clinical findings after responding to the alert. Perceptions of the presence of sepsis at the time of alert were discrepant between nurses (13%) and providers (40%). The majority of clinicians reported no change in perception of the patient's risk for sepsis (55% nurses, 62% providers). A third of nurses (30%) but few providers (9%) reported the alert changed management. Almost half of nurses (42%) but less than a fifth of providers (16%) found the alert helpful at 6 hours. CONCLUSIONS: In general, clinical perceptions of Early Warning System 2.0 were poor. Nurses and providers differed in their perceptions of sepsis and alert benefits. These findings highlight the challenges of achieving acceptance of predictive and machine learning-based sepsis alerts.

A Machine Learning Algorithm to Predict Severe Sepsis and Septic Shock: Development, Implementation, and Impact on Clinical Practice.

OBJECTIVES: Develop and implement a machine learning algorithm to predict severe sepsis and septic shock and evaluate the impact on clinical practice and patient outcomes. DESIGN: Retrospective cohort for algorithm derivation and validation, pre-post impact evaluation. SETTING: Tertiary teaching hospital system in Philadelphia, PA. PATIENTS: All non-ICU admissions; algorithm derivation July 2011 to June 2014 (n = 162,212); algorithm validation October to December 2015 (n = 10,448); silent versus alert comparison January 2016 to February 2017 (silent n = 22,280; alert n = 32,184). INTERVENTIONS: A random-forest classifier, derived and validated using electronic health record data, was deployed both silently and later with an alert to notify clinical teams of sepsis prediction. MEASUREMENT AND MAIN RESULT: Patients identified for training the algorithm were required to have International Classification of Diseases, 9th Edition codes for severe sepsis or septic shock and a positive blood culture during their hospital encounter with either a lactate greater than 2.2 mmol/L or a systolic blood pressure less than 90 mm Hg. The algorithm demonstrated a sensitivity of 26% and specificity of 98%, with a positive predictive value of 29% and positive likelihood ratio of 13. The alert resulted in a small statistically significant increase in lactate testing and IV fluid administration. There was no significant difference in mortality, discharge disposition, or transfer to ICU, although there was a reduction in time-to-ICU transfer. CONCLUSIONS: Our machine learning algorithm can predict, with low sensitivity but high specificity, the impending occurrence of severe sepsis and septic shock. Algorithm-generated predictive alerts modestly impacted clinical measures. Next steps include describing clinical perception of this tool and optimizing algorithm design and delivery.

Effectiveness of indoor allergen reduction in asthma management: A systematic review.

BACKGROUND: This review will inform updated National Asthma Education and Prevention Program clinical practice guidelines. OBJECTIVE: We sought to evaluate the effectiveness of allergen reduction interventions on asthma outcomes. METHODS: We systematically searched the "gray literature" and 5 bibliographic databases. Eligible studies included systematic reviews, randomized controlled trials, and nonrandomized interventional studies. Risk of bias was assessed by using the Cochrane Risk of Bias instrument and the Newcastle-Ottawa scale. The evidence base was assessed by using the approach of the Agency for Healthcare Research and Quality's Evidence-based Practice Center program. RESULTS: Fifty-nine randomized and 8 nonrandomized trials addressed 8 interventions: acaricide, air purification, carpet removal, high-efficiency particulate air filtration (HEPA) vacuums, mattress covers, mold removal, pest control, and pet removal. Thirty-seven studies evaluated single-component interventions, and 30 studies assessed multicomponent interventions. Heterogeneity precluded meta-analysis. For most interventions and outcomes, the evidence base was inconclusive or showed no effect. No interventions were associated with improvement in validated asthma control measures or pulmonary physiology. Exacerbations were diminished in multicomponent studies that included HEPA vacuums or pest control (moderate strength of evidence [SOE] for both). Quality of life improved in studies of air purifiers (SOE: low) and in multicomponent studies that included HEPA vacuums (SOE: moderate) or pest control (SOE: low). CONCLUSIONS: Single interventions were generally not associated with improvement in asthma measures, with most strategies showing inconclusive results or no effect. Multicomponent interventions improved various outcomes, but no combination of specific interventions appears to be more effective. The evidence was often inconclusive because of a lack of studies. Further research is needed comparing the effect of indoor allergen reduction interventions on validated asthma measures, with sufficient population sizes to detect clinically meaningful differences.

Impact of a Hospital Evidence-Based Practice Center (EPC) on Nursing Policy and Practice.

BACKGROUND: In 2006, our healthcare system created a hospital Evidence-based Practice Center (EPC) to support the local delivery of high-quality, safe and high value patient care. Since then, the importance of healthcare staff work life has also been highlighted, and together these four elements form the Quadruple Aim framework. Synergistic to this Aim, the Magnet® program promotes and recognizes organizational nursing excellence. OBJECTIVE: To examine the EPC's work to inform nursing policy and practice in support of the goals of the Quadruple Aim framework and Magnet® designation. METHODS: Methods used included the following: (1) descriptive analysis of the hospital EPC's database of rapid reviews; and (2) administration of a 40-item electronic questionnaire to nurses who requested an EPC review during fiscal years (FY) 2015 and 2016. RESULTS: Of 308 rapid reviews completed in the EPC's first 10 years, 59 (19%) addressed nursing topics. The proportion of reviews relevant to nursing increased from 5% (2/39) in the center's first 2 years to 44% (25/60) in FY 2015-2016. The majority of nursing reviews (39/59) examined processes of care. Of 23 nurses eligible to participate in the survey, 21 responded (91%). Nurses with administrative or managerial responsibilities requested 70% of reviews; clinical nurse specialists and bedside nurses requested 17% and 9%, respectively. Reviews were used to support clinical program development (48%), provide clinical guidance (33%), update nursing policies or procedures (24%) and develop training and curricula (24%). Nurses were satisfied with the hospital EPC reviews (mean; 4.7/5), and 95% indicated they were likely to request a future review. LINKING EVIDENCE TO ACTION: A dedicated hospital EPC in partnership with nursing offers a unique mechanism for promoting a culture of evidence-based practice. Nurses at all organizational levels use the services of a hospital EPC to inform nursing policy and practice and are highly satisfied with the process, supporting the Quadruple Aim and Magnet® designation.

Risk of complications with use of aspirin during renal biopsy: A systematic review.

BACKGROUND: Bleeding is a well-known complication of percutaneous renal biopsy (PRB). Thus, antiplatelet agents are routinely held for most patients undergoing elective PRB to decrease bleeding risk. MATERIALS AND METHODS: In this systematic review, we examine the association between antiplatelet use and bleeding during PRB. MEDLINE and EMBASE were searched from inception to December 2016 using terms that included "renal biopsy", "antiplatelet","aspirin", and "bleeding". Guidelines and systematic reviews were identified primarily through large databases, including the National Guideline Clearinghouse and Cochrane Database of Systematic Reviews. Two authors independently screened the results, and appraised and graded the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: Out of 371 guidelines, 40 systematic reviews, and 709 primary studies originally identified, 4 guidelines, 1 systematic review, and 2 primary studies met inclusion criteria. The guidelines recommend halting aspirin for elective PRB. The systematic review found no difference in major outcomes for PRB in patients for whom aspirin was continued versus halted, but was of low quality. The 2 nonrandomized primary studies in PRB patients managed with and without aspirin found no difference in major bleeds but a higher risk of minor bleeds. CONCLUSIONS: There is low-quality evidence on the effect of aspirin on bleeding risk from PRB. It is reasonable to discontinue aspirin 7 - 10 days prior to nonemergent biopsies, in accordance with guidelines. Given the results from the primary studies, it is reasonable to perform randomized controlled trials to obtain high-quality evidence to inform clinical practice.
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Brain-Type Natriuretic Peptide and Amino-Terminal Pro-Brain-Type Natriuretic Peptide Discharge Thresholds for Acute Decompensated Heart Failure: A Systematic Review.

BACKGROUND: Acute decompensated heart failure (ADHF) requiring hospitalization is associated with high postdischarge mortality and readmission rates. PURPOSE: To examine the association between achieving predischarge natriuretic peptide (NP) thresholds and mortality and readmission rates in adults hospitalized for ADHF. DATA SOURCES: Multiple databases from 1947 to October 2016 (English-language studies only). STUDY SELECTION: Trials and observational studies that compared mortality and readmission outcomes between patients with ADHF achieving a specific predischarge NP goal and those not achieving the goal. DATA EXTRACTION: Two investigators independently extracted study characteristics and assessed study risk of bias. One author graded the overall strength of evidence, with review by a second author. DATA SYNTHESIS: One randomized trial, 3 quasi-experimental studies, and 40 observational studies were identified. The most commonly used thresholds were a brain-type NP (BNP) level of 250 pg/mL or less or an amino-terminal pro-brain-type NP (NT-proBNP) decrease of at least 30%. Achievement of absolute BNP thresholds reduced postdischarge all-cause mortality (7 of 8 studies) and the composite outcome of mortality and readmission (12 of 14 studies). Achievement of percentage-change BNP thresholds reduced the composite outcome (5 of 6 studies), and achievement of percentage-change NT-proBNP thresholds reduced all-cause and cardiovascular mortality (2 of 4 studies) and the composite outcome (9 of 9 studies). All findings were low-strength. The randomized trial, assessed as having high risk of bias, suggested that a predischarge decrease in NT-proBNP level was associated with lower risk for the composite outcome. Two quasi-experimental studies and 5 observational studies had low risk of bias. Low-risk-of-bias studies had outcome estimates similar in magnitude and direction to estimates from high-risk-of-bias studies. LIMITATION: Most studies failed to adjust for critical confounders and had inadequate definition or assessment of exposures and outcomes. CONCLUSION: Low-strength evidence suggests an association between achieving NP predischarge thresholds and reduced ADHF mortality and readmission. PRIMARY FUNDING SOURCE: None.

Transfusion Thresholds for Major Orthopedic Surgery: A Systematic Review and Meta-analysis.

BACKGROUND: More than a million surgeries are performed annually in the United States for hip or knee arthroplasty or hip fracture stabilization. One-fifth of these patients have blood transfusions during their hospital stay. Increases in transfusion rates have caused concern about increased adverse events from unnecessary transfusions. METHODS: We systematically reviewed randomized trials examining the effect of restrictive vs liberal transfusion thresholds on patients having major orthopedic surgery. Study results were meta-analyzed with a random-effects model and heterogeneity was tested with the I2 statistic. Study risk of bias was assessed using a modified Jadad scale and evidence strength was measured using the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) system. RESULTS: A total of 504 published articles were screened, and 15 met inclusion criteria. The articles described 9 randomized trials, most comparing transfusion thresholds of 8 vs 10 g/dL hemoglobin. All involved hip or knee arthroplasty and/or hip fracture patients. Moderate-strength evidence suggested a reduction in need for transfusion (relative risk, 0.53; 95% confidence interval [CI], 0.39-0.71; I2 = 95%) and mean number of units transfused (-0.95 units, 95% CI, -1.48 to -0.41, I2 = 98%). There was a possible reduction in overall infections with more restrictive transfusion thresholds, although the result was not statistically significant (relative risk, 0.71; 95% CI, 0.47-1.06; I2 = 54%). Moderate-strength evidence suggested no differences in other clinical outcomes between the groups. Limitations included incomplete blinding, inconsistency, and imprecision. CONCLUSION: Moderate-strength evidence suggests that restrictive transfusion practices reduce utilization of transfusions and may decrease infections without increasing adverse outcomes in major orthopedic surgery.

Neuromuscular Blocking Agents and Neuromuscular Dysfunction Acquired in Critical Illness: A Systematic Review and Meta-Analysis.

OBJECTIVE: The relationship between neuromuscular blocking agents and neuromuscular dysfunction acquired in critical illness remains unclear. We examined the association between neuromuscular blocking agents and ICU-acquired weakness, critical illness polyneuropathy, and critical illness myopathy. DATA SOURCES: PubMed, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, Cumulative Index of Nursing and Allied Health Literature, and bibliographies of included studies were searched from database inception until September 24, 2015. STUDY SELECTION: Randomized controlled trials and prospective observational studies examining the association between neuromuscular blocking agents and ICU-acquired weakness, critical illness polyneuropathy, or critical illness myopathy. DATA EXTRACTION: One author screened titles/abstracts. Two authors independently reviewed full text and extracted data from included studies. Meta-analysis was performed using the DerSimonian-Laird random effects model (OpenMetaAnalyst 10.10 for OS.X). We assessed reporting bias with funnel plots and heterogeneity with the I statistic. DATA SYNTHESIS: Of 2,170 titles/abstracts screened, 99 full texts were selected for review, yielding one randomized controlled trial and 18 prospective observational studies, for a total of 2,254 patients. The randomized controlled trial did not show an association between neuromuscular blocking agents and neuromuscular dysfunction acquired in critical illness (odds ratio, 1.21; 95% CI, 0.67-2.19), but pooled data from all included studies suggested a modest association (odds ratio, 1.25; 95% CI, 1.06-1.48; I = 16%). Funnel plots suggested reporting bias, and sensitivity analyses showed a disproportionate contribution from critical illness polyneuropathy/critical illness myopathy and severe sepsis/septic shock studies. CONCLUSIONS: This meta-analysis suggests a modest association between neuromuscular blocking agents and neuromuscular dysfunction acquired in critical illness; limitations include studies with a high risk of bias and a disproportionate contribution from studies examining patients for critical illness polyneuropathy/critical illness myopathy and those with severe sepsis/septic shock.

Cleaning Hospital Room Surfaces to Prevent Health Care-Associated Infections: A Technical Brief.

The cleaning of hard surfaces in hospital rooms is critical for reducing health care-associated infections. This review describes the evidence examining current methods of cleaning, disinfecting, and monitoring cleanliness of patient rooms, as well as contextual factors that may affect implementation and effectiveness. Key informants were interviewed, and a systematic search for publications since 1990 was done with the use of several bibliographic and gray literature resources. Studies examining surface contamination, colonization, or infection with Clostridium difficile, methicillin-resistant Staphylococcus aureus, or vancomycin-resistant enterococci were included. Eighty studies were identified-76 primary studies and 4 systematic reviews. Forty-nine studies examined cleaning methods, 14 evaluated monitoring strategies, and 17 addressed challenges or facilitators to implementation. Only 5 studies were randomized, controlled trials, and surface contamination was the most commonly assessed outcome. Comparative effectiveness studies of disinfecting methods and monitoring strategies were uncommon. Future research should evaluate and compare newly emerging strategies, such as self-disinfecting coatings for disinfecting and adenosine triphosphate and ultraviolet/fluorescent surface markers for monitoring. Studies should also assess patient-centered outcomes, such as infection, when possible. Other challenges include identifying high-touch surfaces that confer the greatest risk for pathogen transmission; developing standard thresholds for defining cleanliness; and using methods to adjust for confounders, such as hand hygiene, when examining the effect of disinfecting methods.

Using educational prescriptions to teach medical students evidence-based medicine.

PURPOSE: To evaluate feasibility and impact of evidence-based medicine (EBM) educational prescriptions (EPs) in medical student clerkships. METHODS: Students answered clinical questions during clerkships using EPs, which guide learners through the "four As" of EBM. Epidemiology fellows graded EPs using a rubric. Feasibility was assessed using descriptive statistics and student and fellow end-of-study questionnaires, which also measured impact. In addition, for each EP, students reported patient impact. Impact on EBM skills was assessed by change in EP scores over time and scores on an EBM objective structured clinical exam (OSCE) that were compared to controls from the prior year. RESULTS: 117 students completed 402 EPs evaluated by 24 fellows. Average score was 7.34/9.00 (SD 1.58). 69 students (59%) and 21 fellows (88%) completed questionnaires. Most students thought EPs improved "Acquiring" and "Appraising". Almost half thought EPs improved "Asking" and "Applying". Fellows did not value grading EPs. For 18% of EPs, students reported a "change" or "potential change" in treatment. 56% "confirmed" treatment. EP scores increased by 1.27 (95% CI: 0.81-1.72). There were no differences in OSCE scores between cohorts. CONCLUSIONS: Integrating EPs into clerkships is feasible and has impact, yet OSCEs were unchanged, and research fellows had limitations as evaluators.

Evidence-based risk communication: a systematic review.

BACKGROUND: Effective communication of risks and benefits to patients is critical for shared decision making. PURPOSE: To review the comparative effectiveness of methods of communicating probabilistic information to patients that maximize their cognitive and behavioral outcomes. DATA SOURCES: PubMed (1966 to March 2014) and CINAHL, EMBASE, and the Cochrane Central Register of Controlled Trials (1966 to December 2011) using several keywords and structured terms. STUDY SELECTION: Prospective or cross-sectional studies that recruited patients or healthy volunteers and compared any method of communicating probabilistic information with another method. DATA EXTRACTION: Two independent reviewers extracted study characteristics and assessed risk of bias. DATA SYNTHESIS: Eighty-four articles, representing 91 unique studies, evaluated various methods of numerical and visual risk display across several risk scenarios and with diverse outcome measures. Studies showed that visual aids (icon arrays and bar graphs) improved patients' understanding and satisfaction. Presentations including absolute risk reductions were better than those including relative risk reductions for maximizing accuracy and seemed less likely than presentations with relative risk reductions to influence decisions to accept therapy. The presentation of numbers needed to treat reduced understanding. Comparative effects of presentations of frequencies (such as 1 in 5) versus event rates (percentages, such as 20%) were inconclusive. LIMITATION: Most studies were small and highly variable in terms of setting, context, and methods of administering interventions. CONCLUSION: Visual aids and absolute risk formats can improve patients' understanding of probabilistic information, whereas numbers needed to treat can lessen their understanding. Due to study heterogeneity, the superiority of any single method for conveying probabilistic information is not established, but there are several good options to help clinicians communicate with patients. PRIMARY FUNDING SOURCE: None.

The next organizational challenge: finding and addressing diagnostic error.

BACKGROUND: Although health care organizations (HCOs) are intensely focused on improving the safety of health care, efforts to date have almost exclusively targeted treatment-related issues. The literature confirms that the approaches HCOs use to identify adverse medical events are not effective in finding diagnostic errors, so the initial challenge is to identify cases of diagnostic error. WHY HEALTH CARE ORGANIZATIONS NEED TO GET INVOLVED: HCOs are preoccupied with many quality- and safety-related operational and clinical issues, including performance measures. The case for paying attention to diagnostic errors, however, is based on the following four points: (1) diagnostic errors are common and harmful, (2) high-quality health care requires high-quality diagnosis, (3) diagnostic errors are costly, and (4) HCOs are well positioned to lead the way in reducing diagnostic error. FINDING DIAGNOSTIC ERRORS: Current approaches to identifying diagnostic errors, such as occurrence screens, incident reports, autopsy, and peer review, were not designed to detect diagnostic issues (or problems of omission in general) and/or rely on voluntary reporting. The realization that the existing tools are inadequate has spurred efforts to identify novel tools that could be used to discover diagnostic errors or breakdowns in the diagnostic process that are associated with errors. New approaches--Maine Medical Center's case-finding of diagnostic errors by facilitating direct reports from physicians and Kaiser Permanente's electronic health record--based reports that detect process breakdowns in the followup of abnormal findings--are described in case studies. CONCLUSION: By raising awareness and implementing targeted programs that address diagnostic error, HCOs may begin to play an important role in addressing the problem of diagnostic error.

Statins and cognitive function: a systematic review.

BACKGROUND: Despite the U.S. Food and Drug Administration (FDA) warning regarding cognitive impairment, the relationship between statins and cognition remains unknown. PURPOSE: To examine the effect of statins on cognition. DATA SOURCES: PubMed, Embase, and Cochrane Library from inception through October 2012; FDA databases from January 1986 through March 2012. STUDY SELECTION: Randomized, controlled trials (RCTs) and cohort, case-control, and cross-sectional studies evaluating cognition in patients receiving statins. DATA EXTRACTION: Two reviewers extracted data, 1 reviewer assessed study risk of bias, and 1 reviewer checked all assessments. DATA SYNTHESIS: Among statin users, low-quality evidence suggested no increased incidence of Alzheimer disease and no difference in cognitive performance related to procedural memory, attention, or motor speed. Moderate-quality evidence suggested no increased incidence of dementia or mild cognitive impairment or any change in cognitive performance related to global cognitive performance scores, executive function, declarative memory, processing speed, or visuoperception. Examination of the FDA postmarketing surveillance databases revealed a low reporting rate for cognitive-related adverse events with statins that was similar to the rates seen with other commonly prescribed cardiovascular medications. LIMITATIONS: The absence of many well-powered RCTs for most outcomes resulted in final strengths of evidence that were low or moderate. Imprecision, inconsistency, and risk of bias also limited the strength of findings. CONCLUSION: Larger and better-designed studies are needed to draw unequivocal conclusions about the effect of statins on cognition. Published data do not suggest an adverse effect of statins on cognition; however, the strength of available evidence is limited, particularly with regard to high-dose statins.