Effect of patient characteristics on posttraumatic stress disorder treatment retention among veterans: A systematic review.

To identify baseline patient characteristics (i.e., demographic and psychological factors, military background) associated with better posttraumatic stress disorder (PTSD) treatment retention among veterans, we conducted a systematic review. After an electronic database search for studies of PTSD treatment in veterans, two reviewers independently screened the literature for eligibility, abstracted study-level information, and assessed risk of bias. As most studies used multivariate models to assess multiple potential predictors of retention simultaneously, the results were described narratively. The GRADE approach, adapted for prognostic literature, was used to assess the overall quality of evidence (QoE). In total, 19 studies reported in 25 publications met the inclusion criteria (n = 6 good quality, n = 9 fair quality, n = 4 poor quality). Definitions of treatment completion and dropout varied, and some studies lumped different therapy approaches together. Older age and higher treatment expectations were associated with better retention (moderate QoE). In 5 of 6 studies, baseline PTSD severity was not associated with retention, and the remaining study reported an association between better retention and more severe PTSD symptoms; the presence of more co-occurring psychiatric disorders was associated with better retention (moderate QoE). QoE was low or insufficient to support conclusions for any other characteristics due to inconsistent results, imprecision, potential publication bias, possible study population overlap, study limitations, or lack of studies. More research is needed regarding the associations between modifiable factors (e.g., motivation, barriers, expectations) and retention, and consistent definitions of treatment completion and minimally adequate treatment should be adopted throughout the field.

Diagnosis of Gout: A Systematic Review in Support of an American College of Physicians Clinical Practice Guideline.

BACKGROUND: Alternative strategies exist for diagnosing gout that do not rely solely on the documentation of monosodium urate (MSU) crystals. PURPOSE: To summarize evidence regarding the accuracy of clinical tests and classification algorithms compared with that of a reference standard of MSU crystals in joint aspirate for diagnosing gout. DATA SOURCES: Several electronic databases from inception to 29 February 2016. STUDY SELECTION: 21 prospective cohort, cross-sectional, and case-control studies including participants with joint inflammation and no previous definitive gout diagnosis who had MSU analysis of joint aspirate. DATA EXTRACTION: Data extraction and risk-of-bias assessment by 2 reviewers independently; overall strength of evidence (SOE) judgment by group. DATA SYNTHESIS: Recently developed algorithms including clinical, laboratory, and imaging criteria demonstrated good sensitivity (up to 88%) and fair to good specificity (up to 96%) for diagnosing gout (moderate SOE). Three studies of dual-energy computed tomography (DECT) showed sensitivities of 85% to 100% and specificities of 83% to 92% for diagnosing gout (low SOE). Six studies of ultrasonography showed sensitivities of 37% to 100% and specificities of 68% to 97%, depending on the ultrasonography signs assessed (pooled sensitivity and specificity for the double contour sign: 74% [95% CI, 52% to 88%] and 88% [CI, 68% to 96%], respectively [low SOE]). LIMITATION: Important study heterogeneity and selection bias; scant evidence in primary and urgent care settings and in patients with conditions that may be confused with or occur with gout. CONCLUSION: Multidimensional algorithms, which must be validated in primary and urgent care settings, may help clinicians make a provisional diagnosis of gout. Although DECT and ultrasonography also show promise for gout diagnosis, accessibility to these methods may be limited. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (Protocol registration: https://effectivehealthcare.ahrq.gov/ehc/products/564/1937/gout-protocol-140716.pdf).

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

BACKGROUND: Chronic pain patients increasingly seek treatment through mindfulness meditation. PURPOSE: This study aims to synthesize evidence on efficacy and safety of mindfulness meditation interventions for the treatment of chronic pain in adults. METHOD: We 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. RESULTS: Thirty-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. CONCLUSIONS: While 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.

Stress Control for Military, Law Enforcement, and First Responders: A Systematic Review.

Military personnel, police officers, firefighters, and other first responders must prepare for and respond to life-threatening crises on a daily basis. This lifestyle places stress on personnel, and particularly so on military personnel who may be isolated from support systems and other resources. The authors conducted a systematic review of studies of interventions designed to prevent, identify, and manage acute occupational stress among military, law enforcement, and first responders. The body of evidence consisted of 38 controlled trials, 35 cohort comparisons, and 42 case studies with no comparison group, reported in 136 publications. Interventions consisted of resilience training, stress inoculation with biofeedback, mindfulness, psychological first aid, front-line mental health centers, two- to seven-day restoration programs, debriefing (including critical incident stress debriefing), third-location decompression, postdeployment mental health screening, reintegration programs, and family-centered programs. Study limitations (risk of bias), directness, consistency, precision, and publication bias were considered in rating the quality of evidence for each outcome area. Overall, interventions had positive effects on return to duty, absenteeism, and distress. However, there was no significant impact on symptoms of psychological disorders such as PTSD, depression, and anxiety. Because of study limitations, inconsistency of results, indirectness, and possible publication bias, there was insufficient evidence to form conclusions about the effects of most specific intervention types, components, settings, or specific populations.

Combat and Operational Stress Control Interventions and PTSD: A Systematic Review and Meta-Analysis.

INTRODUCTION: Military personnel must prepare for and respond to life-threatening crises on a daily basis. This lifestyle places stress on personnel, and particularly so on deployed service members who are isolated from support systems and other resources. As part of a larger systematic review on the acceptability, efficacy, and comparative effectiveness of interventions designed to prevent, identify, and manage stress reactions, we assessed posttraumatic stress disorder (PTSD) outcomes. MATERIALS AND METHODS: We searched the electronic databases PsycINFO, PubMed, PTSDPubs, the Defense Technical Information Center, and Cochrane Central, as well as bibliographies of existing systematic reviews, to identify English-language studies evaluating the efficacy or comparative effectiveness of stress control interventions published since 1990. Controlled trials and cohort comparisons of interventions with military, law enforcement, and first responders were included. Two independent reviewers screened literature using predetermined eligibility criteria. Researchers individually abstracted study-level information and outcome data and assessed the risk of bias of included studies; data were reviewed for accuracy by the project leader. Changes in PTSD symptom scores from baseline to post-intervention were converted to standardized mean differences for comparison across studies. Risk ratios were calculated for PTSD case rates post-deployment. When several studies that compared an intervention group with a similar control/comparator reported the same outcome category and measure type, we conducted meta-analysis. We conducted meta-regression by adding a categorical variable, representing setting (i.e., in theater) or population (military vs. law enforcement or first responders) to the meta-analysis model to assess whether this variable was associated with the outcome across studies. The quality of the body of evidence (QoE) was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, which considers study limitations (risk of bias), directness, consistency, precision, and publication bias. RESULTS: Sixteen controlled trials and 13 cohort comparisons reporting PTSD outcomes met inclusion criteria. Eight controlled trials and two cohort studies had high risk of bias, primarily due to poor, differential, or unknown response rate at follow-up. Twenty-four of the 29 studies included military personnel. Interventions included Acceptance-based Skills training, Attention Bias Modification training, stress inoculation with biofeedback, Critical Incident Stress Debriefing, group psychological debriefing, Eye Movement Desensitization and Reprocessing for sub-clinical stress, embedding mental health providers in theater, Third Location Decompression, reintegration programs, and a 3-week post-deployment residential program for psychological resource strengthening.Meta-analyses of studies comparing a group that received a stress control intervention to a group that did not receive an intervention found no significant difference in reduction in PTSD symptom scores (moderate QoE) or PTSD case rate post-deployment (low QoE). A meta-analysis of studies comparing a specific stress control intervention to an active comparator (usually standard stress management education) found no significant effect on PTSD symptom scores (moderate QoE). CONCLUSION: Although combat and operational stress control (COSC) interventions may play a valuable role in decreasing stress, decreasing absenteeism, and enabling return to duty, a systematic review of 29 studies that included a control/comparison group found little evidence that COSC is effective in preventing PTSD or decreasing PTSD symptom scores in military personnel.

Effects of Medication-Assisted Treatment (MAT) for Opioid Use Disorder on Functional Outcomes: A Systematic Review.

This systematic review addresses the question: What are the effects of medication-assisted treatment (MAT) that use buprenorphine, buprenorphine combined with naloxone, methadone, or naltrexone for opioid use disorder (OUD) on functional outcomes compared with wait-list, placebo, treatment without medication, any other comparator, or each other (e.g., buprenorphine versus naltrexone)? Functional outcomes investigated included cognitive (e.g., memory), physical (e.g., fatigue), occupational (e.g., employment status), social/behavioral (e.g., criminal activity), and neurological (e.g., balance) function. The authors searched five scientific research databases from inception to 2017 and reference mined existing reviews. Two independent literature reviewers screened 6,292 citations; 1,327 full-text publications were reviewed in detail and 37 studies met inclusion criteria. Critical appraisals assessed studies in detail, and quality of evidence was rated using established criteria. Results were synthesized in meta-analyses and presented in comprehensive evidence tables. Although MAT patients performed significantly better on some functional outcomes than persons with OUD who did not receive MAT, MAT patients performed worse on several cognitive measures than did matched "healthy" controls with no history of substance use disorder (SUD) or OUD. Because of the moderate-to-high risk of bias of most studies, quality of evidence is low or very low for all findings. The small number of studies reporting on outcomes of interest and the weaknesses in the body of evidence prevent making strong conclusions about MAT effects on functional outcomes. The literature shows that more research is needed that targets functional outcomes specifically, and there is, in particular, a lack of research evaluating potential differences in functional effects among medication types, the route of administration, treatment modality, and length of treatment.

Effects of medication assisted treatment (MAT) for opioid use disorder on functional outcomes: A systematic review.

This systematic review synthesizes evidence on the effects of Medication-Assisted Treatment (MAT) for opioid use disorder (OUD) on functional outcomes, including cognitive (e.g., memory), physical (e.g., fatigue), occupational (e.g., return to work), social/behavioral (e.g., criminal activity), and neurological (e.g., balance) function. Five databases were searched from inception to July 2017 to identify English-language controlled trials, case control studies, and cohort comparisons of one or more groups; cross-sectional studies were excluded. Two independent reviewers screened identified literature, abstracted study-level information, and assessed the quality of included studies. Meta-analyses used the Hartung-Knapp method for random-effects models. The quality of evidence was assessed using the GRADE approach. A comprehensive search followed by 1411 full text publication screenings yielded 30 randomized controlled trials (RCTs) and 10 observational studies meeting inclusion criteria. The studies reported highly diverse functional outcome measures. Only one RCT was rated as high quality, but several methodologically sound observational studies were identified. The statistical power to detect differences in functional outcomes was unclear in most studies. When compared with matched "healthy" controls with no history of substance use disorder (SUD), in two studies MAT patients had significantly poorer working memory and cognitive speed. One study found MAT patients scored worse in aggressive responding than did "healthy" controls. A large observational study found that MAT users had twice the odds of involvement in an injurious traffic accident as non-users. When compared with persons with OUD not on MAT, one cohort study found lower fatigue rates among buprenorphine-treated OUD patients. No differences were reported for occupational outcomes and results for criminal activity and other social/behavioral areas were mixed. There were few differences among MAT drug types. A pooled analysis of three RCTs found a significantly lower prevalence of fatigue with buprenorphine compared to methadone, while a meta-analysis of the same RCTs found no statistical difference in insomnia prevalence. Three RCTs that focused on cognitive function compared the effects of buprenorphine to methadone; no statistically significant differences in memory, cognitive speed and flexibility, attention, or vision were reported. The quality of evidence for most functional outcomes was rated low or very low. In sum, weaknesses in the body of evidence prevent strong conclusions about the effects of MAT for opioid use disorder on functional outcomes. Rigorous studies of functional effects would strengthen the body of literature.

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 Association's 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.

Managing Medicaid behavioral health care: findings of a national survey in the year 2000.

OBJECTIVE: Although Medicaid is the primary payer for public mental health systems, relatively little is known about managed care arrangements at the health plan level. METHODS: A brief cross-sectional survey was customized for each of the 51 Medicaid agencies. Survey data were collected and combined with Centers for Medicare and Medicaid Services data elements. Where possible, analyses were conducted at the state, waiver program, and health plan levels. RESULTS: Findings confirmed that most states were contracting to serve a broad range of Medicaid enrollees. The array of covered benefits was extensive. Health maintenance organization (HMO)-type arrangements accounted for most plans nationally, but 40 percent of plans were specialty carve-outs. Most states used capitation contracts, but a third shared risk with their vendors. A surprising number of states (41 percent) reported using governmental entities as vendors. CONCLUSIONS: By the year 2000, large numbers of public sector clients were being served by HMO-type arrangements. Benefit designs under managed care were perhaps more inclusive than some advocates had feared. The flexibility of capitation financing may have enhanced the ability of health plans to ration care in a clinically informed manner. However, large numbers of vulnerable individuals were receiving care through fully capitated health plans. This finding suggests the need for vigilance by public-sector mental health and substance abuse authorities. Authorities should aggressively pursue opportunities to influence Medicaid policy.

Hyaluronic acid injection therapy for osteoarthritis of the knee: concordant efficacy and conflicting serious adverse events in two systematic reviews.

BACKGROUND: The prevalence of knee osteoarthritis (OA)/degenerative joint disease (DJD) is increasing in the USA. Systematic reviews of treatment efficacy and adverse events (AEs) of hyaluronic acid (HA) injections report conflicting evidence about the balance of benefits and harms. We review evidence on efficacy and AEs of intraarticular viscosupplementation with HA in older individuals with knee osteoarthritis and account for differences in these conclusions from another systematic review. METHODS: We searched PubMed and eight other databases and gray literature sources from 1990 to December 12, 2014. Double-blind placebo-controlled randomized controlled trials (RCTs) reporting functional outcomes or quality-of-life; RCTs and observational studies on delay/avoidance of arthroplasty; RCTs, case reports, and large cohort studies and case series assessing safety; and systematic reviews reporting on knee pain were considered for inclusion. A standardized, pre-defined protocol was applied by two independent reviewers to screen titles and abstracts, review full text, and extract details on study design, interventions, outcomes, and quality. We compared our results with those of a prior systematic review and found them to be discrepant; our analysis of why this discrepancy occurred is the focus of this manuscript. RESULTS: Eighteen RCTs reported functional outcomes: pooled analysis of ten placebo-controlled, blinded trials showed a standardized mean difference of -0.23 (95 % confidence interval (CI) -0.45 to -0.01) favoring HA at 6 months. Studies reported few serious adverse events (SAEs) and no significant differences in non-serious adverse events (NSAEs) (relative risk (RR) [95 % CI] 1.03 [0.93-1.15] or SAEs (RR [95 % CI] 1.39 [0.78-2.47]). A recent prior systematic review reported similar functional outcomes, but significant SAE risk. Differences in SAE inclusion and synthesis accounted for the disparate conclusions. CONCLUSIONS: Trials show a small but significant effect of HA on function on which recent systematic reviews agree, but lack of AE synthesis standardization leads to opposite conclusions about the balance of benefits and harms. A limitation of the re-analysis of the prior systematic review is that it required imputation of missing data.

Omega-3 Fatty Acids and Maternal and Child Health: An Updated Systematic Review.

OBJECTIVES: To update a prior systematic review on the effects of omega-3 fatty acids (n-3 FA) on maternal and child health and to assess the evidence for their effects on, and associations with, additional outcomes. DATA SOURCES: MEDLINE®, Embase®, the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Centre for Agriculture and Biosciences (CAB) Abstracts from 2000 to August 2015; eligible studies from the original report; and relevant systematic reviews. REVIEW METHODS: We included randomized controlled trials (RCTs) of any defined dose of n-3 FA (or combination) compared to placebo, any other n-3 FA, or alternative dose with an outcome of interest conducted in pregnant or breastfeeding women or neonates (preterm or term). We also included prospective observational studies that analyzed the association between baseline n-3 FA intake or biomarker level and followup outcomes. Postnatal interventions began within a week of birth for term infants and within a week of beginning enteral or oral feeding for preterm infants. Standard methods were used for data abstraction and analysis, according to the Evidence-based Practice Center Methods Guide. RESULTS: We identified 4,275 potentially relevant titles from our searches, of which 95 RCTs and 48 observational studies met the inclusion criteria. Risk of bias was a concern with both RCTs and observational studies. Outcomes for which evidence was sufficient to draw a conclusion are summarized here with the Strength of Evidence (SoE). (Outcomes for which the evidence was insufficient to draw a conclusion are summarized in Appendix G of the report.).Maternal Exposures and Outcomes: Gestational length and risk for preterm birth: Prenatal algal docosahexaenoic acid (DHA) or DHA-enriched fish oil supplementation had a small positive effect on length of gestation (moderate SoE), but no effect on risk for preterm birth (low SoE). Prenatal EPA (eicosapentaenoic acid) plus DHA-containing fish oil supplementation has no effect on length of gestation (low SoE). Supplementation with DHA, or EPA plus DHA-, or DHA-enriched fish oil does not decreaserisk for preterm birth (low SoE).Birth weight and risk for low birth weight: Changes in maternal n-3 FA biomarkers were significantly associated with birth weight. Prenatal algal DHA or DHA-enriched fish oil supplementation had a positive effect on birth weight among healthy term infants (moderate SoE), but prenatal DHA supplementation had no effect on risk for low birth weight (low SoE). Prenatal EPA plus DHA or alpha-linolenic acid (ALA) supplementation had no effect on birth weight (low SoE).Risk for peripartum depression: Maternal n-3 FA biomarkers had no association with risk for peripartum depression. Maternal DHA, EPA, or DHA-enriched fish oil supplementation had no effect on risk for peripartum depression (low SoE).Risk for gestational hypertension/preeclampsia: Prenatal DHA supplementation among high-risk pregnant women had no effect on the risk for gestational hypertension or preeclampsia (moderate SoE). Prenatal supplementation of any n-3 FA in normal-risk women also had no significant effect on risk for gestational hypertension or preeclampsia (low SoE).Fetal, Infant, and Child Exposures and Outcomes: Postnatal growth patterns: Maternal fish oil or DHA plus EPA supplementation had no effect on postnatal growth patterns (attainment of weight, length, and head circumference) when administered prenatally (moderate SoE) or both pre- and postnatally (low SoE). Fortification of infant formulas with DHA plus arachidonic acid (AA, an n-6 FA) had no effect on growth patterns of preterm or term infants (low SoE).Visual acuity: Prenatal supplementation with DHA had no effect on development of visual acuity (low SoE). Supplementing or fortifying preterm infant formula with any n-3 FA had no significant effect on visual acuity assessed by visual evoked potentials (VEP) at 4 or 6 months corrected age (low SoE). Data conflicted on the effectiveness of supplementing infant formula for term infants with n-3 FA depending on when and how visual acuity was assessed (i.e. by VEP or by behavioral methods) and the type of essential FA provided (low SoE).Neurological development: Prenatal or postnatal n-3 FA supplementation had no consistent effect on neurological development (low SoE).Cognitive development: Prenatal DHA supplementation with AA or EPA had no effect on cognitive development (moderate SoE). Supplementing breastfeeding women with DHA plus EPA also had no effect on cognitive development in infants and children (low SoE). Supplementing or fortifying preterm infants' formula with DHA plus AA had a positive effect on infant cognition at some short-term followup times (moderate SoE). Supplementing or fortifying infant formula for term infants with any n-3 FA had no effect on cognitive development (low SoE). Evidence is insufficient to support any effect of n-3 FA infant supplementation on long-term cognitive outcomes.Autism spectrum disorder, attention deficit hyperactivity disorder (ADHD), and learning disorders: Maternal or infant n-3 FA supplementation had no effect on risk for autism spectrum disorders or ADHD (low SoE). No studies on other learning disorders were identified.Atopic dermatitis (AD), allergies, and respiratory disorders: Pre- and postnatal (maternal and infant) n-3 FA supplementation had no consistent effect on the risk for AD/eczema, allergies, asthma, and other respiratory illnesses (moderate SoE). Biomarkers and intakes had no consistent association with the risk for AD, allergies, and respiratory disorders (low SoE).Adverse events: Prenatal and infant supplementation with n-3 FA or fortification of foods with n-3 FA did not result in any serious or nonserious adverse events (moderate SoE); with the exception of an increased risk for mild gastrointestinal symptoms. CONCLUSIONS: Most studies in this report examined the effects of fish oil (or other combinations of DHA and EPA) supplements on pregnant or breastfeeding women or the effects of infant formula fortified with DHA plus AA. As with the original report, with the exception of small increases in birth weight and length of gestation,n-3 FA supplementation or fortification has no consistent evidence of effects on peripartum maternal or infant health outcomes. No effects of n-3 FA were seen on gestational hypertension, peripartum depression, or postnatal growth. Apparent effects of n-3 FA supplementation were inconsistent across assessment methods and followup times for outcomes related to infant visual acuity, cognitive development and prevention of allergy and asthma. Future RCTs need to assess standardized preparations of n-3 and n-6 FA, using a select group of clinically important outcomes, on populations with baseline n-3 FA intakes typical of those of most western populations.

Interventions that increase use of adult immunization and cancer screening services: a meta-analysis.

PURPOSE: The relative effectiveness of the diverse approaches used to promote preventive care activities, such as cancer screening and adult immunization, is unknown. Despite many high-quality published studies, practices and policymakers attempting to improve preventive care have little definitive information on which to base decisions. Thus, we quantitatively assessed the relative effectiveness of previously studied approaches for improving adherence to adult immunization and cancer screening guidelines. DATA SOURCES: MEDLINE, the Cochrane Effective Practice and Organization of Care Review Group register, previous systematic reviews, and the Medicare Health Care Quality Improvement Project database. STUDY SELECTION: Controlled clinical trials that assessed interventions to increase use of immunizations for influenza and pneumococcal pneumonia and screening for colon, breast, and cervical cancer in adults. DATA EXTRACTION: Two reviewers independently extracted data on characteristics and outcomes from unmasked articles. Intervention components to increase use of services were classified as reminder, feedback, education, financial incentive, legislative action, organizational change, or mass media campaign. DATA SYNTHESIS: Of 552 abstracts and articles, 108 met the inclusion criteria. To assess the effect of intervention components, meta-regression models were developed for immunizations and each cancer screening service by using 81 studies with a usual care or control group. The most potent intervention types involved organizational change (the adjusted odds ratios for increased use of services from organizational change ranged from 2.47 to 17.6). Organizational change interventions included the use of separate clinics devoted to prevention, use of a planned care visit for prevention, or designation of nonphysician staff to do specific prevention activities. The next most effective intervention components were patient financial incentives (adjusted odds ratios, 1.82 to 3.42) and patient reminders (adjusted odds ratios, 1.74 to 2.75); the adjusted odds ratios ranged from 1.29 to 1.53 for patient education and from 1.10 to 1.76 for feedback. CONCLUSIONS: Rates of adult immunization and cancer screening are most likely to improve when a health care organization supports performance of these activities through organizational changes in staffing and clinical procedures. Involving patients in self-management through patient financial incentives and reminders is also likely to positively affect performance.

Mass mailings have little effect on utilization of influenza vaccine among Medicare beneficiaries.

BACKGROUND: We reviewed published and unpublished studies of mass mailings designed to increase utilization of influenza vaccine among Medicare beneficiaries. METHODS: Search of computerized indexes for published studies and the Medicare Peer Review Organization Health Care Quality Improvement Project database for unpublished studies. Study selection criteria were: use of a controlled trial design and use of mass mailings direct to Medicare beneficiaries to increase receipt of influenza vaccinations. Study selection and data extraction were performed in duplicate by physician reviewers with consensus resolution. RESULTS: Six controlled trials of mass mailings were identified. One study, published in the Morbidity and Mortality Weekly Report (MMWR), reported a modest but statistically significant improvement in influenza vaccination rates among patients who received a letter relative to those who did not. This study was cited as justification for mail interventions performed in five subsequent studies, none of which reported clinically meaningful results. None of these five studies was published. CONCLUSIONS: Mass mailings have at best had clinically trivial effects on increasing influenza vaccination among Medicare beneficiaries. Publication bias has contributed to continued use of a relatively ineffective intervention.

Smoking-cessation interventions by type of provider: a meta-analysis.

OBJECTIVE: To synthesize the evidence on the effectiveness of smoking-cessation interventions by type of provider. METHODS: A random effects meta-regression was estimated to examine the effect of provider and whether the intervention contained nicotine replacement therapy (NRT), on the intervention's relative risk of quitting as compared to placebo or usual care from studies published in databases from inception to 2000. Thirty additional studies not included in the previous 1996 and 2000 U.S. Public Health Service clinical practice guidelines were used to provide the most comprehensive analysis to date of the comparative effectiveness of different types of providers in interventions for smoking cessation that have been published. RESULTS: The effectiveness without NRT follows: psychologist (1.94, 95% confidence interval [CI]: 1.04-3.62); physician (1.87, CI=1.42-2.45); counselor (1.82, CI=0.84-3.96); nurse (1.76, CI=1.21-2.57); unknown (1.27, CI=0.57-2.82); other (1.18, CI=0.67-2.10); and self-help (1.28, CI=0.89-1.82). Effectiveness of most providers increased by almost twofold with the use of NRT. CONCLUSIONS: Smoking-cessation interventions without NRT delivered by psychologists, physicians, or nurses are all effective. NRT increases the effectiveness of most providers.

Reporting of context and implementation in studies of global health interventions: a pilot study.

BACKGROUND: There is an increasing push for 'evidence-based' decision making in global health policy circles. However, at present there are no agreed upon standards or guidelines for how to evaluate evidence in global health. Recent evaluations of existing evidence frameworks that could serve such a purpose have identified details of program context and project implementation as missing components needed to inform policy. We performed a pilot study to assess the current state of reporting of context and implementation in studies of global health interventions. METHODS: We identified three existing criteria sets for implementation reporting and selected from them 10 criteria potentially relevant to the needs of policy makers in global health contexts. We applied these 10 criteria to 15 articles included in the evidence base for three global health interventions chosen to represent a diverse set of advocated global health programs or interventions: household water chlorination, prevention of mother-to-child transmission of HIV, and lay community health workers to reduce child mortality. We used a good-fair-poor/none scale for the ratings. RESULTS: The proportion of criteria for which reporting was poor/none ranged from 11% to 54% with an average of 30%. Eight articles had 'good' or 'fair' documentation for greater than 75% of criteria, while five articles had 'poor or none' documentation for 50% of criteria or more. Examples of good reporting were identified. CONCLUSIONS: Reporting of context and implementation information in studies of global health interventions is mostly fair or poor, and highly variable. The idiosyncratic variability in reporting indicates that global health investigators need more guidance about what aspects of context and implementation to measure and how to report them. This lack of context and implementation information is a major gap in the evidence needed by global health policy makers to reach decisions.

Safety of vaccines used for routine immunization of U.S. 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.

Safety of Vaccines Used for Routine Immunization in the United States.

OBJECTIVES: To conduct a systematic review of the literature on the safety of vaccines recommended for routine immunization of children, adolescents, and adults in the United States as of 2011. DATA SOURCES: We included placebo-controlled clinical trials and cohort studies comparing vaccinated and unvaccinated patients. We also included the following types of post-licensure analyses: case-control studies, self-controlled case series, and multivariate risk factor analyses. We conducted an electronic search of PubMed from inception through August 2013, and reviewed Advisory Committee for Immunization Practices statements, vaccine package inserts, and previously published reviews to identify studies. Scientific Information Packets were requested from vaccine manufacturers. REVIEW METHODS: We reviewed the methodology of the 2011 Institute of Medicine (IOM) consensus report "Adverse Effects of Vaccines: Evidence and Causality" and accepted their findings. We augmented their work with new studies and additional vaccines. For studies not included in the IOM report, we abstracted data on the presence or absence of adverse health outcomes, characteristics of patients, study design, and vaccine description, including brand, potency, dosage, timing, and formulation, where available. We excluded formulations not used in the United States. The McHarm instrument was used to evaluate the quality of adverse events collection and reporting in each study. We were unable to pool results; we rated the overall strength of evidence (SOE) as high, moderate, low, or insufficient by using guidance suggested by the Agency for Healthcare Research and Quality for its Effective Health Care Program. RESULTS: A total of 20,478 titles were identified; after title, abstract, and full-text review, 166 studies were accepted for abstraction. The vast majority of studies either did not investigate or could not identify risk factors for adverse events (AEs) associated with vaccination. Similarly, the severity of AEs was inconsistently reported, as was information that would make independent severity determination possible.SOE was high for the following associations in nonpregnant adults: seasonal influenza vaccine and arthralgia, myalgia, malaise, fever, pain at injection site; 2009 monovalent H1N1 vaccine and Guillain-Barré syndrome (GBS); and a lack of association between influenza and pneumococcal vaccines and cardiovascular events in the elderly. Risk of GBS was estimated at 1.6 excess cases per million persons vaccinated. SOE was high for the following associations in children and adolescents: measles, mumps, rubella (MMR) vaccine and febrile seizures in children under age 5; lack of association between MMR vaccine and autism spectrum disorders; and varicella vaccine and disseminated Oka strain varicella zoster virus with associated complications (i.e., meningitis, encephalitis) in individuals with demonstrated immunodeficiencies. There is moderate SOE that vaccines against rotavirus are associated with intussusception in children; risk was estimated as 1 to 5 cases per 100,000 vaccine doses, depending on brand. Moderate-strength evidence exists regarding human papillomavirus vaccine and a lack of association with onset of juvenile rheumatoid arthritis, type 1 diabetes, and GBS. Moderate-strength evidence shows no association between inactivated influenza vaccine and serious AEs in pregnant women.Evidence was insufficient to make conclusions regarding whether several routinely recommended vaccines are associated with serious conditions such as multiple sclerosis, transverse myelitis, and acute disseminated encephalomyelitis. CONCLUSIONS: There is evidence that some vaccines are associated with serious adverse events; however, these events are extremely rare and must be weighed against the protective benefits that vaccines provide. Careful consideration should be given to the investigation of research gaps, including patient risk factors that may be associated with AEs; however, important factors must be taken into account when determining whether studies are warranted, including the severity and frequency of the AE being studied and the challenges of conducting sufficiently powered studies when investigating rare events.

A proposed approach may help systematic reviews retain needed expertise while minimizing bias from nonfinancial conflicts of interest.

OBJECTIVES: Groups such as the Institute of Medicine emphasize the importance of attention to financial conflicts of interest. Little guidance exists, however, on managing the risk of bias for systematic reviews from nonfinancial conflicts of interest. We sought to create practical guidance on ensuring adequate clinical or content expertise while maintaining independence of judgment on systematic review teams. STUDY DESIGN AND SETTING: Workgroup members built on existing guidance from international and domestic institutions on managing conflicts of interest. We then developed practical guidance in the form of an instrument for each potential source of conflict. RESULTS: We modified the Institute of Medicine's definition of conflict of interest to arrive at a definition specific to nonfinancial conflicts. We propose questions for funders and systematic review principal investigators to evaluate the risk of nonfinancial conflicts of interest. Once risks have been identified, options for managing conflicts include disclosure followed by no change in the systematic review team or activities, inclusion on the team along with other members with differing viewpoints to ensure diverse perspectives, exclusion from certain activities, and exclusion from the project entirely. CONCLUSION: The feasibility and utility of this approach to ensuring needed expertise on systematic reviews and minimizing bias from nonfinancial conflicts of interest must be investigated.

A surveillance system to assess the need for updating systematic reviews.

BACKGROUND: Systematic reviews (SRs) can become outdated as new evidence emerges over time. Organizations that produce SRs need a surveillance method to determine when reviews are likely to require updating. This report describes the development and initial results of a surveillance system to assess SRs produced by the Agency for Healthcare Research and Quality (AHRQ) Evidence-based Practice Center (EPC) Program. METHODS: Twenty-four SRs were assessed using existing methods that incorporate limited literature searches, expert opinion, and quantitative methods for the presence of signals triggering the need for updating. The system was designed to begin surveillance six months after the release of the original review, and then ceforth every six months for any review not classified as being a high priority for updating. The outcome of each round of surveillance was a classification of the SR as being low, medium or high priority for updating. RESULTS: Twenty-four SRs underwent surveillance at least once, and ten underwent surveillance a second time during the 18 months of the program. Two SRs were classified as high, five as medium, and 17 as low priority for updating. The time lapse between the searches conducted for the original reports and the updated searches (search time lapse - STL) ranged from 11 months to 62 months: The STL for the high priority reports were 29 months and 54 months; those for medium priority reports ranged from 19 to 62 months; and those for low priority reports ranged from 11 to 33 months. Neither the STL nor the number of new relevant articles was perfectly associated with a signal for updating. Challenges of implementing the surveillance system included determining what constituted the actual conclusions of an SR that required assessing; and sometimes poor response rates of experts. CONCLUSION: In this system of regular surveillance of 24 systematic reviews on a variety of clinical interventions produced by a leading organization, about 70% of reviews were determined to have a low priority for updating. Evidence suggests that the time period for surveillance is yearly rather than the six months used in this project.