Primary Care Interventions to Prevent Child Maltreatment: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: Child maltreatment, also referred to as child abuse and neglect, can result in lifelong negative consequences. Objective: To update the evidence on interventions provided in or referable from primary care to prevent child maltreatment for the US Preventive Services Task Force. Data Sources: PubMed, Cochrane Library, EMBASE, and trial registries through December 18, 2017; references; experts; literature surveillance through July 17, 2018. Study Selection: English-language fair- and good-quality randomized clinical trials that (1) included children with no known exposure to maltreatment and no signs or symptoms of current or past maltreatment, (2) evaluated interventions feasible in a primary care setting or that could result from a referral from primary care, and (3) reported abuse or neglect outcomes or proxies for abuse or neglect (eg, injury with a specificity for abuse, visits to the emergency department, hospitalization). Data Extraction and Synthesis: Two reviewers independently assessed titles/abstracts, full-text articles, and study quality; a third resolved conflicts when needed. When at least 3 similar trials were available, random-effects meta-analyses were conducted. Main Outcomes and Measures: Direct measures (including reports to child protective services and removal of the child from the home) or proxy measures of abuse or neglect; behavioral, emotional, mental, or physical well-being; and harms. Results: Twenty-two trials (33 publications) were included (N = 11 132). No significant association was found between interventions and reports to child protective services within 1 year of intervention completion (10.6% vs 11.9%; pooled odds ratio [OR], 0.94 [95% CI, 0.72-1.23]; 10 trials [n = 2444]) or removal of the child from the home within 1 to 3 years of follow-up (3.5% vs 3.7%; pooled OR, 1.09 [95% CI, 0.16-7.28]; 4 trials [n = 609]). No statistically significant associations were observed between interventions and outcomes for emergency department visits in the short term (<2 years), hospitalizations, child development, school performance, and prevention of death. Nonsignificant results from single trials led to a conclusion of insufficient evidence for injuries, failure to thrive, failure to immunize, school attendance, and other measures of abuse or neglect. Inconsistent results led to a conclusion of insufficient evidence for long-term (≥2 years) outcomes for reports to child protective services (ORs range from 0.48 to 1.13; 3 trials [n = 1690]), emergency department visits (1 of 2 trials reported significant differences) and internalizing and externalizing behavior symptoms (3 of 6 trials reported reductions in behavior difficulties). No eligible trials on harms of interventions were identified. Conclusions and Relevance: Interventions provided in or referable from primary care did not consistently prevent child maltreatment. No evidence on harms is available.

Comparative Benefits and Harms of Complementary and Alternative Medicine Therapies for Initial Treatment of Major Depressive Disorder: Systematic Review and Meta-Analysis.

OBJECTIVES: To report the comparative benefits and harms of exercise and complementary and alternative medicine (CAM) treatments with second-generation antidepressants (SGA) for major depressive disorder (MDD). DESIGN: Systematic review and meta-analysis. SETTINGS: Outpatient clinics. SUBJECTS: Adults, aged 18 years and older, with MDD receiving an initial treatment attempt with SGA. INTERVENTIONS: Any CAM or exercise intervention compared with an SGA. OUTCOME MEASURES: Treatment response, remission, change in depression rating, adverse events, treatment discontinuation, and treatment discontinuation due to adverse events. RESULTS: We found 22 randomized controlled trials for direct comparisons and 127 trials for network meta-analyses, including trials of acupuncture, omega-3 fatty acids, S-adenosyl methionine, St. John's wort, and exercise. For most treatment comparisons, we found no differences between treatment groups for response and remission. However, the risk of bias of these studies led us to conclude that the strength of evidence for these findings was either low or insufficient. The risk of treatment harms and treatment discontinuation attributed to adverse events was higher for selective serotonin receptor inhibitors than for St. John's wort. CONCLUSIONS: Although we found little difference in the comparative efficacy of most CAM therapies or exercise and SGAs, the overall poor quality of the available evidence base tempers any conclusions that we might draw from those trials. Future trials should incorporate patient-oriented outcomes, treatment expectancy, depressive severity, and harms assessments into their designs; antidepressants should be administered over their full dosage ranges; and larger trials using methods to reduce sampling bias are needed.

The Effectiveness of Total Worker Health Interventions: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.

BACKGROUND: The Total Worker Health (TWH) program of the National Institute for Occupational Safety and Health aims to advance worker well-being by integrating injury and illness prevention efforts with work-related safety and health hazard efforts. PURPOSE: To evaluate evidence on the benefits and harms of integrated TWH interventions. DATA SOURCES: MEDLINE, Cochrane Library, and PsycINFO (January 1990 through September 2015); clinical trial registries; and reference lists. STUDY SELECTION: English-language studies that enrolled employed adults and compared integrated interventions with usual work practice, no intervention, or another intervention. DATA EXTRACTION: Dual abstraction and risk-of-bias (ROB) assessment. DATA SYNTHESIS: Ten of the 15 included studies had high ROB, primarily because of selection and attrition bias. Findings graded as having low strength of evidence (SOE) supported the effectiveness of TWH interventions for improving smoking cessation, as measured by self-reported 7-day abstinence over 22 to 26 weeks (2 randomized, controlled trials [RCTs]; n = 737), and increasing consumption of fruits and vegetables over 26 to 104 weeks (3 RCTs; n = 6056); results apply to populations of blue-collar manufacturing and construction workers. Findings graded as having low SOE supported the effectiveness of TWH interventions for reducing sedentary work behavior in office workers over 16 to 52 weeks (2 RCTs; n = 262). Evidence was insufficient or lacking for other outcomes of interest, such as rates of work injuries, quality of life, and harms. LIMITATION: Small, diverse body of evidence with many methodological limitations; possible publication bias. CONCLUSION: Integrated TWH interventions might improve health behaviors (for example, reduce tobacco use and sedentary behavior and improve diet) of workers, but effects of these interventions on injuries and overall quality of life are not known. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Screening for Speech and Language Delay in Children 5 Years Old and Younger: A Systematic Review.

BACKGROUND AND OBJECTIVES: No recommendation exists for or against routine use of brief, formal screening instruments in primary care to detect speech and language delay in children through 5 years of age. This review aimed to update the evidence on screening and treating children for speech and language since the 2006 US Preventive Services Task Force systematic review. METHODS: Medline, the Cochrane Library, PsycInfo, Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov, and reference lists. We included studies reporting diagnostic accuracy of screening tools and randomized controlled trials reporting benefits and harms of treatment of speech and language. Two independent reviewers extracted data, checked accuracy, and assigned quality ratings using predefined criteria. RESULTS: We found no evidence for the impact of screening on speech and language outcomes. In 23 studies evaluating the accuracy of screening tools, sensitivity ranged between 50% and 94%, and specificity ranged between 45% and 96%. Twelve treatment studies improved various outcomes in language, articulation, and stuttering; little evidence emerged for interventions improving other outcomes or for adverse effects of treatment. Risk factors associated with speech and language delay were male gender, family history, and low parental education. A limitation of this review is the lack of well-designed, well-conducted studies addressing whether screening for speech and language delay or disorders improves outcomes. CONCLUSIONS: Several screening tools can accurately identify children for diagnostic evaluations and interventions, but evidence is inadequate regarding applicability in primary care settings. Some treatments for young children identified with speech and language delays and disorders may be effective.

Surgical treatments for otitis media with effusion: a systematic review.

BACKGROUND AND OBJECTIVE: The near universality of otitis media with effusion (OME) in children makes a comparative review of treatment modalities important. This study's objective was to compare the effectiveness of surgical strategies currently used for managing OME. METHODS: We identified 3 recent systematic reviews and searched 4 major electronic databases. Eligible studies included randomized controlled trials, nonrandomized trials, and cohort studies that compared myringotomy, adenoidectomy, tympanostomy tubes (tubes), and watchful waiting. Using established criteria, pairs of reviewers independently selected, extracted data, rated risk of bias, and graded strength of evidence of relevant studies. We incorporated meta-analyses from the earlier reviews and synthesized additional evidence qualitatively. RESULTS: We identified 41 unique studies through the earlier reviews and our independent searches. In comparison with watchful waiting or myringotomy (or both), tubes decreased time with OME and improved hearing; no specific tube type was superior. Adenoidectomy alone, as an adjunct to myringotomy, or combined with tubes, reduced OME and improved hearing in comparison with either myringotomy or watchful waiting. Tubes and watchful waiting did not differ in language, cognitive, or academic outcomes. Otorrhea and tympanosclerosis were more common in ears with tubes. Adenoidectomy increased the risk of postsurgical hemorrhage. CONCLUSIONS: Tubes and adenoidectomy reduce time with OME and improve hearing in the short-term. Both treatments have associated harms. Large, well-controlled studies could help resolve the risk-benefit ratio by measuring acute otitis media recurrence, functional outcomes, quality of life, and long-term outcomes. Research is needed to support treatment decisions in subpopulations, particularly in patients with comorbidities.

Health literacy interventions and outcomes: an updated systematic review.

OBJECTIVES: To update a 2004 systematic review of health care service use and health outcomes related to differences in health literacy level and interventions designed to improve these outcomes for individuals with low health literacy. Disparities in health outcomes and effectiveness of interventions among different sociodemographic groups were also examined. DATA SOURCES: We searched MEDLINE®, the Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library, PsychINFO, and the Educational Resources Information Center. For health literacy, we searched using a variety of terms, limited to English and studies published from 2003 to May 25, 2010. For numeracy, we searched from 1966 to May 25, 2010. REVIEW METHODS: We used standard Evidence-based Practice Center methods of dual review of abstracts, full-text articles, abstractions, quality ratings, and strength of evidence grading. We resolved disagreements by consensus. We evaluated whether newer literature was available for answering key questions, so we broadened our definition of health literacy to include numeracy and oral (spoken) health literacy. We excluded intervention studies that did not measure health literacy directly and updated our approach to evaluate individual study risk of bias and to grade strength of evidence. RESULTS: We included good- and fair-quality studies: 81 studies addressing health outcomes (reported in 95 articles including 86 measuring health literacy and 16 measuring numeracy, of which 7 measure both) and 42 studies (reported in 45 articles) addressing interventions. Differences in health literacy level were consistently associated with increased hospitalizations, greater emergency care use, lower use of mammography, lower receipt of influenza vaccine, poorer ability to demonstrate taking medications appropriately, poorer ability to interpret labels and health messages, and, among seniors, poorer overall health status and higher mortality. Health literacy level potentially mediates disparities between blacks and whites. The strength of evidence of numeracy studies was insufficient to low, limiting conclusions about the influence of numeracy on health care service use or health outcomes. Two studies suggested numeracy may mediate the effect of disparities on health outcomes. We found no evidence concerning oral health literacy and outcomes. Among intervention studies (27 randomized controlled trials [RCTs], 2 cluster RCTs, and 13 quasi-experimental designs), the strength of evidence for specific design features was low or insufficient. However, several specific features seemed to improve comprehension in one or a few studies. The strength of evidence was moderate for the effect of mixed interventions on health care service use; the effect of intensive self-management inventions on behavior; and the effect of disease-management interventions on disease prevalence/severity. The effects of other mixed interventions on other health outcomes, including knowledge, self-efficacy, adherence, and quality of life, and costs were mixed; thus, the strength of evidence was insufficient. CONCLUSIONS: The field of health literacy has advanced since the 2004 report. Future research priorities include justifying appropriate cutoffs for health literacy levels prior to conducting studies; developing tools that measure additional related skills, particularly oral (spoken) health literacy; and examining mediators and moderators of the effect of health literacy. Priorities in advancing the design features of interventions include testing novel approaches to increase motivation, techniques for delivering information orally or numerically, "work around" interventions such as patient advocates; determining the effective components of already-tested interventions; determining the cost-effectiveness of programs; and determining the effect of policy and practice interventions.

Enhancing the use and quality of colorectal cancer screening.

OBJECTIVES: To conduct a systematic review of the use and quality (including underuse, overuse, and misuse) of appropriate colorectal cancer (CRC) screening, including factors associated with screening, effective interventions to improve screening rates, current capacity, and monitoring and tracking the use and quality. Trends in the use and quality of CRC screening tests is also presented. DATA SOURCES: We searched MEDLINE, the Cochrane Library, and the Cochrane Central Trials Registry, supplemented by handsearches, for studies published in English from January 1998 through September 2009. REVIEW METHODS: We used standard Evidence-based Practice Center methods of dual review of abstracts, full text articles, abstractions, quality rating, and quality grading. We resolved disagreements by consensus. RESULTS: We found multiple problems of underuse, overuse, and misuse of CRC screening. We identified a total of 116 articles for inclusion into the systematic review, including a total of 72 studies qualified for inclusion for key question (KQ) 2, 21 for KQ 3, 12 for KQ 4, and 8 for KQ 5. A number of patient-level factors are associated with lower screening rates, including having low income or less education, being uninsured or of Hispanic or Asian descent, not being acculturated into the United States, and having less or reduced access to care. Being insured, of higher income or education, and non-Hispanic white, participating in other cancer screenings, having a family history of CRC or personal history of another cancer, as well as receiving a physician recommendation to be screened, are associated with higher screening rates. Interventions that effectively increased CRC screening with high strength of evidence include patient reminders, one-on-one interactions, eliminating structural barriers, and system-level changes. The largest magnitude of improvement came from one-on-one interactions and eliminating barriers. Purely educational small-media interventions do not improve screening rates. Evidence is mixed for decision aids, although certain designs may be effective. No studies tested interventions to reduce overuse or misuse of CRC screening. We found no studies that assessed monitoring systems for underuse, overuse, and misuse of CRC screening. Modeling studies, using various assumptions, show that if the United States were to adopt a colonoscopy-only approach to CRC screening and everyone were to agree to be screened in this way, it is likely that colonoscopy capacity would need to be substantially increased. CONCLUSIONS: Both CRC screening and patient-physician discussions of CRC screening are underused, and important problems of overuse and misuse also exist. Some interventions hold promise for improvement. The research priority is to design and test interventions to increase screening and CRC screening discussions, building on the effective approaches identified in this review, and tailored to specific population needs. In addition, new interventions to reduce overuse and misuse should be designed and tested, along with studies of ongoing monitoring systems that are linked to feedback and continued improvement efforts.

Communication message strategies for increasing knowledge about prostate cancer screening.

BACKGROUND: This community-based intervention study examined the effects of 2 different message strategies for presenting information about the prostate specific antigen (PSA) test. METHODS: A quasi-experimental longitudinal design with 2 intervention and 1 control group. RESULTS: Knowledge increased significantly among participants who received either version of the intervention message and remained elevated at 12 months. Presenting information in the context of other men's health issues was associated with greater increases in knowledge relative to PSA only. CONCLUSIONS: Community-based interventions can increase knowledge about prostate cancer screening. Clinicians need to take careful account of what their patients understand and correct misperceptions.

Outcomes of community health worker interventions.

OBJECTIVES: To conduct a systematic review of the evidence on characteristics of community health workers (CHWs) and CHW interventions, outcomes of such interventions, costs and cost-effectiveness of CHW interventions, and characteristics of CHW training. DATA SOURCES: We searched MEDLINE, Cochrane Collaboration resources, and the Cumulative Index to Nursing and Allied Health Literature for studies published in English from 1980 through November 2008. REVIEW METHODS: We used standard Evidence-based Practice Center methods of dual review of abstracts, full-text articles, abstractions, quality ratings, and strength of evidence grades. We resolved disagreements by consensus. RESULTS: We included 53 studies on characteristics and outcomes of CHW interventions, 6 on cost-effectiveness, and 9 on training. CHWs interacted with participants in a broad array of locations, using a spectrum of materials at varying levels of intensity. We classified 8 studies as low intensity, 18 as moderate intensity, and 27 as high intensity, based on the type and duration of interaction. Regarding outcomes, limited evidence (five studies) suggests that CHW interventions can improve participant knowledge when compared with alternative approaches such as no intervention, media, mail, or usual care plus pamphlets. We found mixed evidence for CHW effectiveness on participant behavior change (22 studies) and health outcomes (27 studies): some studies suggested that CHW interventions can result in greater improvements in participant behavior and health outcomes when compared with various alternatives, but other studies suggested that CHW interventions provide no statistically different benefits than alternatives. Low or moderate strength of evidence suggests that CHWs can increase appropriate health care utilization for some interventions (30 studies). The literature showed mixed results of effectiveness when analyzed by clinical context: CHW interventions had the greatest effectiveness relative to alternatives for some disease prevention, asthma management, cervical cancer screening, and mammography screening outcomes. CHW interventions were not significantly different from alternatives for clinical breast examination, breast self-examination, colorectal cancer screening, chronic disease management, or most maternal and child health interventions. Six studies with economic and cost information yielded insufficient data to evaluate the cost-effectiveness of CHW interventions relative to other community health interventions. Limited evidence described characteristics of CHW training; no studies examined the impact of CHW training on health outcomes. CONCLUSIONS: CHWs can serve as a means of improving outcomes for underserved populations for some health conditions. The effectiveness of CHWs in numerous areas requires further research that addresses the methodological limitations of prior studies and that contributes to translating research into practice.

Biologics for the treatment of juvenile idiopathic arthritis: a systematic review and critical analysis of the evidence.

Biologics are an important therapeutic option for treating patients with juvenile idiopathic arthritis (JIA). In adults, they are associated with rare but severe adverse events such as serious infections and malignancies. We reviewed systematically the evidence on the efficacy and safety of biologics for the treatment of JIA. We searched electronic databases up to August 2006. We limited evidence to prospective studies for efficacy but included retrospective observational evidence for safety. Outcomes of interest were clinical response, radiographic progression, quality of life, and adverse events. One randomized controlled trial (RCT) and 11 uncontrolled prospective studies provided data on efficacy; three additional studies assessed safety. The only RCT and six uncontrolled trials support the general efficacy of etanercept for the treatment of JIA. Internal and external validity of these studies are limited. The evidence on other biologic agents such as adalimumab, abatacept, anakinra, infliximab, rituximab, and tocilizumab is sparse or entirely missing. Because of the lack of sound long-term safety data, evidence is insufficient to draw firm conclusions about the balance of risks and benefits of any biologic agent for the treatment of JIA. Clinicians have to be aware of the lack of evidence supporting a long-term net benefit when considering biologics for patients with JIA.

Systematic review: comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis.

BACKGROUND: The comparative effectiveness of rheumatoid arthritis therapies is uncertain. PURPOSE: To compare the benefits and harms of disease-modifying antirheumatic drugs (DMARDs) for adults with rheumatoid arthritis. DATA SOURCES: Records limited to the English language and studies of adults were identified by using MEDLINE, EMBASE, The Cochrane Library, and International Pharmaceutical Abstracts from 1980 to September 2007. STUDY SELECTION: Two persons independently selected relevant head-to-head trials and prospective cohort studies with at least 100 participants and 12-week follow-up and relevant good- or fair-quality meta-analyses that compared benefits or harms of 11 drug therapies. For harms, they included retrospective cohort studies. DATA EXTRACTION: Information on study design, interventions, outcomes, and quality were extracted according to a standard protocol. DATA SYNTHESIS: Head-to-head trials (n = 23), mostly examining synthetic DMARDs, showed no clinically important differences in efficacy among synthetic DMARDs (limited to methotrexate, leflunomide, and sulfasalazine) or among anti-tumor necrosis factor drugs (adalimumab, etanercept, and infliximab). Monotherapy with anti-tumor necrosis factor drugs resulted in better radiographic outcomes than did methotrexate but no important differences in clinical outcomes (for example, 20%, 50%, or 70% improvement according to American College of Rheumatology response criteria). Various combinations of biological DMARDs plus methotrexate improved clinical response rates and functional outcomes more than monotherapy with either methotrexate or biological DMARDs. In patients whose monotherapy failed, combination therapy with synthetic DMARDs improved response rates. Numbers and types of short-term adverse events were similar for biological and synthetic DMARDs. The evidence was insufficient to draw conclusions about differences for rare but serious adverse events for biological DMARDs. LIMITATION: Most studies were short-term efficacy trials conducted in selected populations with few comorbid conditions. CONCLUSION: Limited available comparative evidence does not support one monotherapy over another for adults with rheumatoid arthritis. Although combination therapy is more effective for patients whose monotherapy fails, the evidence is insufficient to draw firm conclusions about whether one combination or treatment strategy is better than another or is the best treatment for early rheumatoid arthritis.

Management of uterine fibroids: an update of the evidence.

OBJECTIVES: The RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center (RTI-UNC EPC) systematically updated evidence on the management of uterine fibroids, specifically incidence and prevalence of fibroids, treatment outcomes, comparisons of treatment, modifiers of outcomes, and costs. DATA SOURCES: We searched MEDLINE(R), Cochrane Collaboration resources, and Embase. REVIEW METHODS: We included studies published in English from February 2000 through August 2006. We excluded studies with low sample size (based on study design, cases series < 100 and cohorts < 40) or lack of relevance to uterine fibroids. Of 107 included studies, 3 were good quality, 56 fair, and 48 poor. RESULTS: The cumulative incidence by age 50 is 70 percent to 80 percent; black women are more likely to get fibroids at younger ages. Appearance of new fibroids and growth of existing fibroids after treatment are poorly studied. Trials of preoperative medical management indicate that treatment reduces fibroid volume but do not provide sufficient evidence of improvement in important operative outcomes. When women are treated for reasons other than symptom relief, such as when pregnancy is desired, weak evidence supports treating submucous fibroids via hysteroscopy. No well-conducted trials in U.S. populations directly compared treatment options, including the option of expectant management, or followed women to determine whether the intervention met their treatment objectives. Common procedures such as hysterectomy and myomectomy, including choice among types of myomectomy, still cannot be meaningfully compared. Studies comparing uterine artery embolization (UAE) with other procedures reported procedure time and length of stay favoring UAE, but inconsistency of the direction of effect for complications and absence of key information on longer-term outcomes suggest that this evidence base is inadequate to comment on the relative risks and benefits of UAE versus hysterectomy or myomectomy. Costs of fibroid treatment, despite shorter average lengths of stay, are rising. CONCLUSIONS: The dearth of high-quality evidence supporting the effectiveness of most interventions for uterine fibroids is remarkable, given how common this problem is. The current state of the literature does not permit definitive conclusions about benefit, harm, or relative costs to help guide women's choices. Significant research gaps include well-conducted trials in U.S. populations that directly compare interventions on short- and, especially, long-term outcomes, studies on therapeutics for medical management, and information on treatment decisions for women who desire a pregnancy.

Systematic review: smoking cessation intervention strategies for adults and adults in special populations.

BACKGROUND: While smoking cessation interventions have been shown to work, questions remain about how to increase their efficacy. PURPOSE: To examine strategies for effective tobacco treatment in adults and special populations. DATA SOURCES: MEDLINE, Cumulative Index to Nursing and Applied Health (CINAHL), Cochrane Library, Cochrane Clinical Trials Register, Psychological Abstracts, and Sociological Abstracts (1 January 1980 to 10 June 2005). STUDY SELECTION: Systematic reviews; randomized, controlled trials; and observational studies. DATA EXTRACTION: Two reviewers independently abstracted data on study design, population, sample size, treatment, outcomes, and quality. DATA SYNTHESIS: Findings from systematic reviews were summarized and compared with findings from original research published beyond date ranges included in the reviews. Strength of evidence was used to assess the body of evidence. Our review included studies evaluating the efficacy of cessation strategies, such as self-help, counseling, single pharmaceutical agents, combined pharmacotherapies, and pharmacotherapies combined with psychological counseling. Research findings consistent with previous reviews show that self-help strategies alone are ineffective, but counseling and pharmacotherapy used either alone or in combination can improve rates of success with quit attempts. Two studies of self-help materials reported discrepancies across effects. Five studies provided mixed results for counseling interventions. Fourteen studies provided sufficient evidence of the efficacy of single pharmacotherapy, combined pharmacotherapy, and psychological interventions either with or without pharmacotherapy. Few studies focused on ways to reach or treat special populations. Three studies with hospitalized patients had findings consistent with a previous review showing no strong evidence that clinical diagnosis affected the likelihood of quitting. New evidence was insufficient to address the effectiveness of interventions for persons with coexisting psychiatric conditions and substance abuse problems. LIMITATIONS: Previous systematic reviews variably cover the range of issues we addressed. More recent studies do not fill all gaps, especially those for persons with coexisting disease. CONCLUSIONS: Although self-help strategies alone marginally affect quit rates, individual and combined pharmacotherapies and counseling either alone or in combination can significantly increase cessation. Using effective smoking treatments is strongly encouraged for all populations, especially those with high and heavy rates of smoking, such as psychiatric and substance abuse populations.

Tobacco use: prevention, cessation, and control.

OBJECTIVES: The RTI International-University of North Carolina at Chapel Hill Evidence-based Practice Center (RTI-UNC EPC) systematically reviewed the evidence on (a) the effectiveness of community- and population-based interventions to prevent tobacco use and to increase consumer demand for and implementation of effective cessation interventions; (b) the impacts of smokeless tobacco marketing on smoking, use of those products, and population harm; and (c) the directions for future research. DATA SOURCES: We searched MEDLINE, Cumulative Index to Nursing and Applied Health (CINAHL), Cochrane libraries, Cochrane Clinical Trials Register, Psychological Abstracts, and Sociological Abstracts from January 1980 through June 10, 2005. We included English-language randomized controlled trials, other trials, and observational studies, with sample size and follow-up restrictions. We used 13 Cochrane Collaboration systematic reviews, 5 prior systematic reviews, and 2 meta-analyses as the foundation for this report. REVIEW METHODS: Trained reviewers abstracted detailed data from included articles into evidence tables and completed quality assessments; other senior reviewers confirmed accuracy and resolved disagreements. RESULTS: We identified 1,288 unique abstracts; 642 did not meet inclusion criteria, 156 overlapped with prior reviews, and 2 were not published articles. Of 488 full-text articles retrieved and reviewed, we excluded 298 for several reasons, marked 88 as background, and retained 102. Evidence (consistent with previous reviews) showed that (a) school-based prevention interventions have short-term (but not long-term) effects on adolescents; (b) multicomponent approaches, including telephone counseling, increase the number of users who attempt to quit; (c) self-help strategies alone are ineffective, but counseling and pharmacotherapy used either alone or in combination can improve success rates of quit attempts; and (d) provider training and academic detailing improve provider delivery of cessation treatments, but evidence is insufficient to show that these approaches yield higher quit rates. New evidence was insufficient to address the following: (a) effectiveness of population-based prevention interventions; (b) effectiveness of provider-based interventions to reduce tobacco initiation; (c) effectiveness of community- and provider-based interventions to increase use of proven cessation strategies; (d) effectiveness of marketing campaigns to switch tobacco users from smoking to smokeless tobacco products; and (e) effectiveness of interventions in populations with comorbidities and risk behaviors (e.g., depression, substance and alcohol abuse). No evidence was available on the way in which smokeless tobacco product marketing affects population harm. CONCLUSIONS: The evidence base has notable gaps and numerous study deficiencies. We found little information to address some of the issues that previous authoritative reviews had not covered, some information to substantiate earlier conclusions and recommendations from those reviews, and no evidence that would overturn any previous recommendations.

The comparative efficacy and safety of biologics for the treatment of rheumatoid arthritis: a systematic review and metaanalysis.

OBJECTIVE: Biologics are an important therapeutic option for treating patients with rheumatoid arthritis (RA). However, they are associated with rare but severe adverse events such as serious infections, lymphoma, or chronic heart failure. In addition, dosing regimens and routes of administration differ substantially among biologics. In a systematic review, we assessed the comparative efficacy and safety of biologic agents for RA. METHODS: We searched electronic databases up to May 2006. We limited evidence to controlled trials for efficacy but included observational evidence for safety. Outcomes of interest were clinical response, radiographic progression, and quality of life. Given the paucity of head-to-head evidence, we conducted adjusted, indirect comparisons of placebo-controlled trials. RESULTS: Twenty-six controlled trials provided efficacy data; 18 additional studies assessed safety. The only evidence directly comparing 2 biologic agents was a nonrandomized, open-label trial that found no differences in effectiveness and safety between etanercept and infliximab. Adjusted indirect comparisons indicate no significant differences in efficacy between anti-tumor necrosis factor (TNF) drugs. However, anti-TNF drugs appear to be more efficacious than anakinra, although not all comparisons reached statistical significance. Because of the lack of sound longterm safety data, evidence is insufficient to draw firm conclusions about the comparative safety of biologics. CONCLUSION: Anti-TNF drugs appear to be more efficacious than anakinra but do not differ significantly among each other. Clinical considerations such as comorbidities, route of administration, dosing regimens, and specific side effect profiles may guide the choice of an anti-TNF drug.

Challenges in systematic reviews of economic analyses.

Economic analyses can provide valuable information for health care decision makers. Systematic reviews of economic analyses can integrate information from multiple studies and provide important insights by systematically examining how differences between models lead to different results. We use our experience in developing and implementing systematic reviews of economic analyses for the U.S. Preventive Services T ask Force, particularly our systematic review of the cost-effectiveness of colorectal cancer screening, to illustrate key methodologic challenges and suggest a framework for other researchers in this area.

Discontinuation rates for selective serotonin reuptake inhibitors and other second-generation antidepressants in outpatients with major depressive disorder: a systematic review and meta-analysis.

The present study aimed to systematically compare overall loss to follow-up, discontinuation rates because of adverse events and discontinuation rates because of a lack of efficacy in published studies assessing the efficacy and tolerability of selective serotonin reuptake inhibitors (SSRIs) compared to other second-generation antidepressants in treating outpatients with major depressive disorder (MDD). We searched MEDLINE, Embase, The Cochrane Library, PsychLit and the International Pharmaceutical Abstracts from 1980 to 2004 (April). Twenty double-blinded, randomized controlled trials met our eligibility criteria and compared SSRIs to other second-generation antidepressants in adult outpatients with MDD. Pooled relative risks of discontinuation rates because of (i) any reason (overall loss to follow-up), (ii) adverse events and (iii) a lack of efficacy did not differ substantially between SSRIs as a class and other second-generation antidepressants. Taking the similar efficacy of second-generation antidepressant into account, our findings suggest that clinicians can focus on other practically or clinically relevant considerations such as costs, differences in side-effect profiles, onset of action or aspects of health-related quality of life to tailor a treatment to an individual patient's needs.

Assessing the need to update prevention guidelines: a comparison of two methods.

BACKGROUND: An important concern for developers of clinical practice guidelines is how best to determine when guidelines require updating to ensure they remain current and evidence based. Because of the high costs associated with updating guidelines, recent attention has focused on approaches that can reliably assess the extent of updating required. Recently, Shekelle and colleagues proposed a model of limited literature searches with modest expert involvement as a way to reduce the cost and time requirements for assessing whether a guideline needs updating. METHODS: The main objective of this study was to compare the Shekelle et al. assessment model (review approach) and a conventional process using typical systematic review methods (traditional approach) in terms of comprehensiveness and effort. We modeled the review approach on that by Shekelle and colleagues but refined it iteratively over three phases to achieve greater efficiency. Using both methods independently, we assessed the need to update six topics from the 1996 Guide to Clinical Preventive Services from the US Preventive Services Task Force. Main outcomes included completeness of study identification, importance of missed studies and the effort involved. RESULTS: Although the review approach identified fewer eligible studies than the traditional approach, none of the studies missed was rated as important by task force members acting as liaisons to the project with respect to whether the topic required an update. On average, the review approach produced substantially fewer citations to review than the traditional approach. The effort involved and potential time saving depended largely on the scope of the topic. CONCLUSIONS: The revised review approach provides an efficient and acceptable method for judging whether a guideline requires updating.

Screening for suicide risk in adults: a summary of the evidence for the U.S. Preventive Services Task Force.

BACKGROUND: Suicide is the 11th leading cause of death and the seventh leading cause of years of potential life lost in the United States. Although suicide is of great public health significance, its clinical management is complicated. PURPOSE: The authors systematically reviewed the literature to determine whether screening for suicide risk in primary care settings decreases morbidity, mortality, or both. DATA SOURCES: MEDLINE (1966 to 17 October 2002), PsycINFO, Cochrane databases, hand-searched bibliographies, and experts. STUDY SELECTION: For screening, only English-language studies performed in primary care settings were examined. For treatment, randomized, controlled trials and cohort studies were included if they were performed in any setting where suicide completions, suicide attempts, or suicidal ideation were reported. DATA EXTRACTION: A primary reviewer abstracted data on key variables of study sample, design, and outcomes; a second reviewer checked information accuracy against the original articles. DATA SYNTHESIS: No study directly addressed whether screening for suicide in primary care reduces morbidity and mortality. The remainder of the review focused on the questions of reliable screening tests for suicide risk and the effectiveness of interventions to decrease depression, suicidal ideation, and suicide attempts or completion. One screening study provided limited evidence for the accuracy of suicide screening in a primary care setting. Intervention studies provided fair and mixed evidence that treating those at risk for suicide reduces the number of suicide attempts or completions. The evidence suggests mild to moderate improvement for interventions addressing intermediate outcomes such as suicidal ideation, decreased depressive severity, decreased hopelessness, or improved level of function. CONCLUSION: Because of the complexity of studying the risk for suicide and the paucity of well-designed research studies, only limited evidence guides the primary care clinician's assessment and management of suicide risk.

Physicians' roles in preventing dental caries in preschool children: a summary of the evidence for the U.S. Preventive Services Task Force.

CONTEXT: Almost 20% of children aged 2 to 5 years have untreated dental caries. Physician interventions to prevent and manage dental caries in preschool children could help address this common problem. OBJECTIVE: To review the evidence for effectiveness of five possible physician interventions- (1) screening and risk assessment, (2) referral, (3) provision of dietary supplemental fluoride, (4) application of fluoride varnish, and (5) counseling-for the prevention of dental caries for the U.S. Preventive Services Task Force. DATA SOURCES: Articles from 1966 to 2001 addressing the effectiveness of primary care clinicians' interventions to prevent or manage dental caries were identified in MEDLINE. The evidence for effectiveness of supplemental fluorides, fluoride varnish, and counseling for caries prevention performed by dental personnel was also examined through existing and new systematic reviews. DATA SYNTHESIS: For most key questions related to the five interventions, the evidence for primary care clinician effectiveness was rated as poor owing to the scarcity of studies. Ten surveys of physicians' knowledge and behavior about fluoride supplementation provided fair evidence, suggesting that supplementation decisions were often made without consideration of other fluoride exposures. Reviews of the dental literature identified fair evidence supporting the effectiveness of both fluoride supplements and varnish, although information describing effectiveness and adverse outcomes of supplementation with the most recent dosage schedule is not available. CONCLUSIONS: Evidence for the effectiveness of traditionally recommended primary care clinician interventions (screening, referral, counseling) to prevent dental caries in preschool children is lacking. There is fair evidence for the effectiveness of two fluoride-based interventions (fluoride supplementation and varnish) applicable in primary care practice. However, there is also fair evidence indicating that physicians' consideration of fluoride exposure is incomplete, thus increasing the risk for fluorosis among those prescribed supplements.