Roberta Shanman

Probiotics for the Prevention and Treatment of Antibiotic-Associated Diarrhea: A Systematic Review and Meta-analysis

CONTEXT Probiotics are live microorganisms intended to confer a health benefit when consumed. One condition for which probiotics have been advocated is the diarrhea that is a common adverse effect of antibiotic use. OBJECTIVE To evaluate the evidence for probiotic use in the prevention and treatment of antibiotic-associated diarrhea (AAD). DATA SOURCES Twelve electronic databases were searched (DARE, Cochrane Library of Systematic Reviews, CENTRAL, PubMed, EMBASE, CINAHL, AMED, MANTIS, TOXLINE, ToxFILE, NTIS, and AGRICOLA) and references of included studies and reviews were screened from database inception to February 2012, without language restriction. STUDY SELECTION Two independent reviewers identified parallel randomized controlled trials (RCTs) of probiotics (Lactobacillus, Bifidobacterium, Saccharomyces, Streptococcus, Enterococcus, and/or Bacillus) for the prevention or treatment of AAD. DATA EXTRACTION Two independent reviewers extracted the data and assessed trial quality. RESULTS A total of 82 RCTs met inclusion criteria. The majority used Lactobacillus-based interventions alone or in combination with other genera; strains were poorly documented. The pooled relative risk in a DerSimonian-Laird random-effects meta-analysis of 63 RCTs, which included 11 811 participants, indicated a statistically significant association of probiotic administration with reduction in AAD (relative risk, 0.58; 95% CI, 0.50 to 0.68; P < .001; I(2), 54%; [risk difference, -0.07; 95% CI, -0.10 to -0.05], [number needed to treat, 13; 95% CI, 10.3 to 19.1]) in trials reporting on the number of patients with AAD. This result was relatively insensitive to numerous subgroup analyses. However, there exists significant heterogeneity in pooled results and the evidence is insufficient to determine whether this association varies systematically by population, antibiotic characteristic, or probiotic preparation. CONCLUSIONS The pooled evidence suggests that probiotics are associated with a reduction in AAD. More research is needed to determine which probiotics are associated with the greatest efficacy and for which patients receiving which specific antibiotics.

Meta-analysis: Effect of Interactive Communication Between Collaborating Primary Care Physicians and Specialists

BACKGROUND Whether collaborative care models that enable interactive communication (timely, 2-way exchange of pertinent clinical information directly between primary care and specialist physicians) improve patient outcomes is uncertain. PURPOSE To assess the effects of interactive communication between collaborating primary care physicians and key specialists on outcomes for patients receiving ambulatory care. DATA SOURCES PubMed, PsycInfo, EMBASE, CINAHL, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, and Web of Science through June 2008 and secondary references, with no language restriction. STUDY SELECTION Studies that evaluated the effects of interactive communication between collaborating primary care physicians and specialists on outcomes for patients with diabetes, psychiatric conditions, or cancer. DATA EXTRACTION Contextual, intervention, and outcome data from 23 studies were extracted by one reviewer and checked by another. Study quality was assessed with a 13-item checklist. Disagreement was resolved by consensus. Main outcomes for analysis were selected by reviewers who were blinded to study results. DATA SYNTHESIS Meta-analysis indicated consistent effects across 11 randomized mental health studies (pooled effect size, -0.41 [95% CI, -0.73 to -0.10]), 7 nonrandomized mental health studies (pooled effect size, -0.47 [CI, -0.84 to -0.09]), and 5 nonrandomized diabetes studies (pooled effect size, -0.64 [CI, -0.93 to -0.34]). These findings remained robust to sensitivity analyses. Meta-regression indicated studies that included interventions to enhance the quality of information exchange had larger effects on patient outcomes than those that did not (-0.84 vs. -0.27; P = 0.002). LIMITATIONS Because collaborative interventions were inherently multifaceted, the efficacy of interactive communication by itself cannot be established. Inclusion of study designs with lower internal validity increased risk for bias. No studies involved oncologists. CONCLUSION Consistent and clinically important effects suggest a potential role of interactive communication for improving the effectiveness of primary care-specialist collaboration. PRIMARY FUNDING SOURCE RAND Healths Comprehensive Assessment of Reform Options Initiative, the Veterans Affairs Center for the Study of Provider Behavior, The Commonwealth Fund, and the Health Foundation.

Safety of Vaccines Used for Routine Immunization of US Children: A Systematic Review

BACKGROUND: Concerns about vaccine safety have led some parents to decline recommended vaccination of their children, leading to the resurgence of diseases. Reassurance of vaccine safety remains critical for population health. This study systematically reviewed the literature on the safety of routine vaccines recommended for children in the United States. METHODS: Data sources included PubMed, Advisory Committee on Immunization Practices statements, package inserts, existing reviews, manufacturer information packets, and the 2011 Institute of Medicine consensus report on vaccine safety. We augmented the Institute of Medicine report with more recent studies and increased the scope to include more vaccines. Only studies that used active surveillance and had a control mechanism were included. Formulations not used in the United States were excluded. Adverse events and patient and vaccine characteristics were abstracted. Adverse event collection and reporting was evaluated by using the McHarm scale. We were unable to pool results. Strength of evidence was rated as high, moderate, low, or insufficient. RESULTS: Of 20 478 titles identified, 67 were included. Strength of evidence was high for measles/mumps/rubella (MMR) vaccine and febrile seizures; the varicella vaccine was associated with complications in immunodeficient individuals. There is strong evidence that MMR vaccine is not associated with autism. There is moderate evidence that rotavirus vaccines are associated with intussusception. Limitations of the study include that the majority of studies did not investigate or identify risk factors for AEs; and the severity of AEs was inconsistently reported. CONCLUSIONS: We found evidence that some vaccines are associated with serious AEs; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide.

Hospital fall prevention: a systematic review of implementation, components, adherence, and effectiveness

To systematically document the implementation, components, comparators, adherence, and effectiveness of published fall prevention approaches in U.S. acute care hospitals.

Quality measures for supportive cancer care: the Cancer Quality-ASSIST Project.

Patients and physicians often cite symptom control as one of their most important goals in cancer care. Despite this, a previous systematic review found few tools for evaluating the quality of supportive cancer management. We developed a comprehensive set of quality indicators for evaluating pain and nonpain symptom management as well as care planning needs in cancer patients. Based on the prevalence and quality-of-life data, clinician-researchers prioritized pain, psychosocial distress, dyspnea, nausea and vomiting, fatigue and anorexia, treatment-associated toxicities, and information and care planning for quality-indicator development. Using search terms and selection criteria, we identified English-language documents from Medline (1997-2007) and Internet-based searches. Based on this evidence, clinician-reviewers proposed process quality indicators. We then used the VA Health Services Research and Development (VA HSR & D) appropriateness methods to compile the ratings of a multidisciplinary, international expert panel of the validity and feasibility of each indicator. The panel judged 92 out of 133 (69%) proposed quality indicators valid and feasible (15 out of 23 pain, 5 out of 6 depression, 8 out of 11 dyspnea, 15 out of 19 nausea and vomiting, 13 out of 26 fatigue and anorexia, 23 out of 32 other treatment-associated toxicities, and 13 out of 16 information and care planning). Of the final indicators, 67 are potentially useful for inpatient and 81 for outpatient evaluation, and 26 address screening, 12 diagnostic evaluation, 20 management, and 21 follow-up. These quality indicators provide evidence-explicit tools for measuring processes critical to ensuring high-quality supportive cancer care. Research is needed to characterize adherence to recommended practices and to evaluate the use of these measures in quality improvement efforts.

Mindfulness Meditation for Chronic Pain: Systematic Review and Meta-analysis

BackgroundChronic pain patients increasingly seek treatment through mindfulness meditation.PurposeThis study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults.MethodWe conducted a systematic review on randomized controlled trials (RCTs) with meta-analyses using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the GRADE approach. Outcomes included pain, depression, quality of life, and analgesic use.ResultsThirty-eight RCTs met inclusion criteria; seven reported on safety. We found low-quality evidence that mindfulness meditation is associated with a small decrease in pain compared with all types of controls in 30 RCTs. Statistically significant effects were also found for depression symptoms and quality of life.ConclusionsWhile mindfulness meditation improves pain and depression symptoms and quality of life, additional well-designed, rigorous, and large-scale RCTs are needed to decisively provide estimates of the efficacy of mindfulness meditation for chronic pain.

Wrong-Site Surgery, Retained Surgical Items, and Surgical Fires : A Systematic Review of Surgical Never Events

IMPORTANCE Serious, preventable surgical events, termed never events, continue to occur despite considerable patient safety efforts. OBJECTIVE To examine the incidence and root causes of and interventions to prevent wrong-site surgery, retained surgical items, and surgical fires in the era after the implementation of the Universal Protocol in 2004. DATA SOURCES We searched 9 electronic databases for entries from 2004 through June 30, 2014, screened references, and consulted experts. STUDY SELECTION Two independent reviewers identified relevant publications in June 2014. DATA EXTRACTION AND SYNTHESIS One reviewer used a standardized form to extract data and a second reviewer checked the data. Strength of evidence was established by the review team. Data extraction was completed in January 2015. MAIN OUTCOMES AND MEASURES Incidence of wrong-site surgery, retained surgical items, and surgical fires. RESULTS We found 138 empirical studies that met our inclusion criteria. Incidence estimates for wrong-site surgery in US settings varied by data source and procedure (median estimate, 0.09 events per 10,000 surgical procedures). The median estimate for retained surgical items was 1.32 events per 10,000 procedures, but estimates varied by item and procedure. The per-procedure surgical fire incidence is unknown. A frequently reported root cause was inadequate communication. Methodologic challenges associated with investigating changes in rare events limit the conclusions of 78 intervention evaluations. Limited evidence supported the Universal Protocol (5 studies), education (4 studies), and team training (4 studies) interventions to prevent wrong-site surgery. Limited evidence exists to prevent retained surgical items by using data-matrix-coded sponge-counting systems (5 pertinent studies). Evidence for preventing surgical fires was insufficient, and intervention effects were not estimable. CONCLUSIONS AND RELEVANCE Current estimates for wrong-site surgery and retained surgical items are 1 event per 100,000 and 1 event per 10,000 procedures, respectively, but the precision is uncertain, and the per-procedure prevalence of surgical fires is not known. Root-cause analyses suggest the need for improved communication. Despite promising approaches and global Universal Protocol evaluations, empirical evidence for interventions is limited.

Meditation for Posttraumatic Stress: Systematic Review and Meta-analysis.

Objective: We conducted a systematic review and meta-analysis that synthesized evidence from randomized controlled trials of meditation interventions to provide estimates of their efficacy and safety in treating adults diagnosed with posttraumatic stress disorder (PTSD). This review was based on an established protocol (PROSPERO: CRD42015025782) and is reported according to PRISMA guidelines. Outcomes of interest included PTSD symptoms, depression, anxiety, health-related quality of life, functional status, and adverse events. Method: Meta-analyses were conducted using the Hartung-Knapp-Sidik-Jonkman method for random-effects models. Quality of evidence was assessed using the Grade of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Results: In total, 10 trials on meditation interventions for PTSD with 643 participants met inclusion criteria. Across interventions, adjunctive meditation interventions of mindfulness-based stress reduction, yoga, and the mantram repetition program improve PTSD and depression symptoms compared with control groups, but the findings are based on low and moderate quality of evidence. Effects were positive but not statistically significant for quality of life and anxiety, and no studies addressed functional status. The variety of meditation intervention types, the short follow-up times, and the quality of studies limited analyses. No adverse events were reported in the included studies; only half of the studies reported on safety. Conclusions: Meditation appears to be effective for PTSD and depression symptoms, but in order to increase confidence in findings, more high-quality studies are needed on meditation as adjunctive treatment with PTSD-diagnosed participant samples large enough to detect statistical differences in outcomes.

Efficacy of mindfulness meditation for smoking cessation: A systematic review and meta-analysis

BACKGROUND Smokers increasingly seek alternative interventions to assist in cessation or reduction efforts. Mindfulness meditation, which facilitates detached observation and paying attention to the present moment with openness, curiosity, and acceptance, has recently been studied as a smoking cessation intervention. AIMS This review synthesizes randomized controlled trials (RCTs) of mindfulness meditation (MM) interventions for smoking cessation. METHODS Five electronic databases were searched from inception to October 2016 to identify English-language RCTs evaluating the efficacy and safety of MM interventions for smoking cessation, reduction, or a decrease in nicotine cravings. Two independent reviewers screened literature using predetermined eligibility criteria, abstracted study-level information, and assessed the quality of included studies. Meta-analyses used the Hartung-Knapp-Sidik-Jonkman method for random-effects models. The quality of evidence was assessed using the GRADE approach. FINDINGS Ten RCTs of MM interventions for tobacco use met inclusion criteria. Intervention duration, intensity, and comparison conditions varied considerably. Studies used diverse comparators such as the American Lung Associations Freedom from Smoking (FFS) program, quitline counseling, interactive learning, or treatment as usual (TAU). Only one RCT was rated as good quality and reported power calculations indicating sufficient statistical power. Publication bias was detected. Overall, mindfulness meditation did not have significant effects on abstinence or cigarettes per day, relative to comparator groups. The small number of studies and heterogeneity in interventions, comparators, and outcomes precluded detecting systematic differences between adjunctive and monotherapy interventions. No serious adverse events were reported. CONCLUSIONS MM did not differ significantly from comparator interventions in their effects on tobacco use. Low-quality evidence, variability in study design among the small number of existing studies, and publication bias suggest that additional, high-quality adequately powered RCTs should be conducted.

Incorporating evidence review into quality improvement: meeting the needs of innovators

Background Achieving quality improvement (QI) aims often requires local innovation. Without objective evidence review, innovators may miss previously tested approaches, rely on biased information, or use personal preferences in designing and implementing local QI programmes. Aim To develop a practical, responsive approach to evidence review for QI innovations aimed at both achieving the goals of the Patient Centered Medical Home (PCMH) and developing an evidence-based QI culture. Design Descriptive organisational case report. Methods As part of a QI initiative to develop and spread innovations for achieving the Veterans Affairs (VA) PCMH (termed Patient Aligned Care Team, or PACT), we involved a professional evidence review team (consisting of review experts, an experienced librarian, and administrative support) in responding to the evidence needs of front-line primary care innovators. The review team developed a systematic approach to responsive innovation evidence review (RIER) that focused on innovator needs in terms of time frame, type of evidence and method of communicating results. To assess uptake and usefulness of the RIERs, and to learn how the content and process could be improved, we surveyed innovation leaders. Results In the first 16 months of the QI initiative, we produced 13 RIERs on a variety of topics. These were presented as 6–15-page summaries and as slides at a QI collaborative. The RIERs focused on innovator needs (eg, topic overviews, how innovations are carried out, or contextual factors relevant to implementation). All 17 innovators who responded to the survey had read at least one RIER; 50% rated the reviews as very useful and 31%, as probably useful. Conclusions These responsive evidence reviews appear to be a promising approach to integrating evidence review into QI processes.