Patient Characteristics and Telemedicine Use in the US, 2022.

Importance: Telemedicine use was common during the COVID-19 pandemic, expanding many patients' approaches to accessing health care. Of concern is whether telemedicine access was poorer among higher-needs and disadvantaged populations. Objective: To assess patient characteristics associated with telemedicine use and telemedicine mode and describe telemedicine visit experiences by telemedicine mode. Design, Setting, and Participants: This cross-sectional study included data from the 2022 Health Information National Trends Survey and included US adults with a health care visit. Data were analyzed from May to September 2023. Exposure: Patient characteristics. Main Outcomes and Measures: Any telemedicine visits vs in-person visits only; telemedicine mode (video vs audio-only). Multivariable logistic models assessed patient characteristics associated with telemedicine visits and mode. Bivariate analyses compared telemedicine experiences by mode. Results: The study included 5437 adult patients (mean [SE] age, 49.4 [0.23] years; 3136 females [53.4%]; 1928 males [46.6%]). In 2022, 2384 patients (43%) had a telemedicine visit; 1565 (70%) had a video visit while 819 (30%) had an audio-only visit. In multivariable models, older age (≥75 years: adjusted odds ratio [aOR], 0.63; 95% CI, 0.42-0.94), no internet use (aOR, 0.62; 95% CI, 0.48-0.81), and living in the Midwest (aOR, 0.50; 95% CI, 0.35-0.70) were negatively associated with having telemedicine visits. Female sex (aOR, 1.43; 95% CI, 1.12-1.83), having chronic conditions (aOR, 2.13; 95% CI, 1.66-2.73), and multiple health care visits (2-4 visits: aOR, 1.77; 95% CI, 1.23-2.54; ≥5 visits: aOR, 3.29; 95% CI, 2.20-4.92) were positively associated. Among individuals who used telemedicine, older age (65-74 years: aOR, 2.13; 95% CI, 1.09-4.14; ≥75 years: aOR, 3.58; 95% CI, 1.60-8.00), no health insurance (aOR, 2.84; 95% CI, 1.42-5.67), and no internet use (aOR, 2.11; 95% CI, 1.18-3.78) were positively associated with having audio-only visits. We observed no significant differences in telemedicine use or mode by education, race and ethnicity, or income. Patients' experiences using telemedicine were generally similar for video and audio-only except more individuals who used audio-only had privacy concerns (20% vs 12%, P = .02). Conclusions and Relevance: In this cross-sectional study of adults with health care visits, many patients, including those with the greatest care needs, chose telemedicine even after in-person visits were available. These findings support continuing this care delivery approach as an option valued by patients. Differences were not observed by most common measures of socioeconomic status. Continued monitoring of telemedicine use is needed to ensure equitable access to health care innovations.

A tool to assess risk of bias in non-randomized follow-up studies of exposure effects (ROBINS-E).

BACKGROUND: Observational epidemiologic studies provide critical data for the evaluation of the potential effects of environmental, occupational and behavioural exposures on human health. Systematic reviews of these studies play a key role in informing policy and practice. Systematic reviews should incorporate assessments of the risk of bias in results of the included studies. OBJECTIVE: To develop a new tool, Risk Of Bias In Non-randomized Studies - of Exposures (ROBINS-E) to assess risk of bias in estimates from cohort studies of the causal effect of an exposure on an outcome. METHODS AND RESULTS: ROBINS-E was developed by a large group of researchers from diverse research and public health disciplines through a series of working groups, in-person meetings and pilot testing phases. The tool aims to assess the risk of bias in a specific result (exposure effect estimate) from an individual observational study that examines the effect of an exposure on an outcome. A series of preliminary considerations informs the core ROBINS-E assessment, including details of the result being assessed and the causal effect being estimated. The assessment addresses bias within seven domains, through a series of 'signalling questions'. Domain-level judgements about risk of bias are derived from the answers to these questions, then combined to produce an overall risk of bias judgement for the result, together with judgements about the direction of bias. CONCLUSION: ROBINS-E provides a standardized framework for examining potential biases in results from cohort studies. Future work will produce variants of the tool for other epidemiologic study designs (e.g. case-control studies). We believe that ROBINS-E represents an important development in the integration of exposure assessment, evidence synthesis and causal inference.

Delayed and Forgone Health Care Among Adults With Limited English Proficiency During the Early COVID-19 Pandemic.

BACKGROUND: Individuals with limited English proficiency (LEP) have long faced barriers in navigating the health care system. More information is needed to understand whether their care was limited further during the early period of the COVID-19 pandemic. OBJECTIVE: To assess the impact of English proficiency on delayed and forgone health care during the early COVID-19 pandemic. RESEARCH DESIGN: Multivariate logistic regression analysis of National Health Interview Survey data (July-December 2020; n=16,941). Outcomes were self-reported delayed and forgone health care because of cost or the COVID-19 pandemic. Delayed health care included medical, dental, mental health, and pharmacy care. Forgone health care also included care at home from a health professional. RESULTS: A greater percentage of LEP adults reported delayed (49%) and forgone (41%) health care than English-proficient adults (40% and 30%, respectively). However, English proficiency was not significantly associated with delayed or forgone health care, after adjusting for demographic, socioeconomic, and health factors. Among LEP adults, multivariate models showed that being uninsured, having a disability, and having chronic conditions increased the risk of delaying and forgoing health care. LEP adults of Asian race and Hispanic ethnicity were also more likely to forgo health care while those with 65+ years were less likely to forgo health care. CONCLUSIONS: Adults with LEP were more likely to experience challenges accessing health care early in the pandemic. Delayed and forgone health care were explained by low socioeconomic status and poor health. These findings highlight how during a period of limited health resources, deficiencies in the health care system resulted in an already disadvantaged group being at greater risk of inequitable access to care.

Differences in Telemedicine, Emergency Department, and Hospital Utilization Among Nonelderly Adults with Limited English Proficiency Post-COVID-19 Pandemic: a Cross-Sectional Analysis.

BACKGROUND: The unprecedented use of telemedicine during the COVID-19 pandemic provided an opportunity to examine its uptake among individuals with limited English proficiency (LEP). OBJECTIVE: To assess telemedicine use among nonelderly adults with LEP and the association between use of telehealth and emergency department (ED) and hospital visits. DESIGN: Cross-sectional study using the National Health Interview Survey (July 2020-December 2021) PARTICIPANTS: Adults (18-64 years), with LEP (N=1488) or English proficiency (EP) (N=25,873) MAIN MEASURES: Telemedicine, ED visits, and hospital visits in the past 12 months. We used multivariate logistic regression to assess (1) the association of English proficiency on having telemedicine visits; and (2) the association of English proficiency and telemedicine visits on having ED and hospital visits. KEY RESULTS: Between July 2020 and December 2021, 22% of adults with LEP had a telemedicine visit compared to 35% of adults with EP. After controlling for predisposing, enabling, and need factors, adults with LEP had 20% lower odds of having a telemedicine visit than adults with EP (p=0.02). While English proficiency was not associated with ED or hospital visits during this time, adults with telemedicine visits had significantly greater odds of having any ED (aOR: 1.80, p<0.001) and hospital visits (aOR: 2.03, p<0.001) in the past 12 months. CONCLUSIONS: While telemedicine use increased overall during the COVID-19 pandemic, its use remained much less likely among adults with LEP. Interventions targeting structural barriers are needed to address disparities in access to telemedicine. More research is needed to understand the relationship between English proficiency, telemedicine visits, and downstream ED and hospital visits.

Interventions to Improve Outcomes for High-Need, High-Cost Patients: A Systematic Review and Meta-Analysis.

BACKGROUND: Chronic disease patients who are the greatest users of healthcare services are often referred to as high-need, high-cost (HNHC). Payers, providers, and policymakers in the United States are interested in identifying interventions that can modify or reduce preventable healthcare use among these patients, without adversely impacting their quality of care and health. We systematically reviewed the evidence on the effectiveness of complex interventions designed to change the healthcare of HNHC patients, modifying cost and utilization, as well as clinical/functional, and social risk factor outcomes. METHODS: We searched 8 electronic databases (January 2000 to March 2021) and selected non-profit organization and government agency websites for randomized controlled trials and observational studies with comparison groups that targeted HNHC patients. Two investigators independently screened each study and abstracted data into structured forms. Study quality was assessed using standard risk of bias tools. Random-effects meta-analysis was conducted for outcomes reported by at least 3 comparable samples. RESULTS: Forty studies met our inclusion criteria. Interventions were heterogenous and classified into 7 categories, reflecting the predominant service location/modality (home, primary care, ambulatory intensive caring unit [aICU], emergency department [ED], community, telephonic/mail, and system-level). Home-, primary care-, and ED-based interventions resulted in reductions in high-cost healthcare services (ED and hospital use). ED-based interventions also resulted in greater use of primary care. Primary care- and ED-based interventions reduced costs. System-level transformation interventions did not reduce costs. DISCUSSION: We found limited evidence of intervention effectiveness in relation to cost and use, and additional evidence is needed to strengthen our confidence in the findings. Few studies reported patient clinical/functional or social risk factor outcomes (e.g., homelessness) or sufficient details for determining why individual interventions work, for whom, and when. Future evaluations could provide additional insights, by including intermediate process outcomes and patients' experiences, in assessing the impact of these complex interventions. PROSPERO REGISTRATION NUMBER: CRD42020161179.

Characteristics of High-Need, High-Cost Patients : A "Best-Fit" Framework Synthesis.

BACKGROUND: Accurately identifying high-need, high-cost (HNHC) patients to reduce their preventable or modifiable health care use for their chronic conditions is a priority and a challenge for U.S. policymakers, health care delivery systems, and payers. PURPOSE: To identify characteristics and criteria to distinguish HNHC patients. DATA SOURCES: Searches of multiple databases and gray literature from 1 January 2000 to 22 January 2022. STUDY SELECTION: English-language studies of characteristics and criteria to identify HNHC adult patients, defined as those with high use (emergency department, inpatient, or total services) or high cost. DATA EXTRACTION: Independent, dual-review extraction and quality assessment. DATA SYNTHESIS: The review included 64 studies comprising multivariate exposure studies (n = 47), cluster analyses (n = 11), and qualitative studies (n = 6). A National Academy of Medicine (NAM) taxonomy was an initial "best-fit" framework for organizing the synthesis of the findings. Patient characteristics associated with being HNHC included number and severity of comorbid conditions and having chronic clinical conditions, particularly heart disease, chronic kidney disease, chronic lung disease, diabetes, cancer, and hypertension. Patients' risk for being HNHC was often amplified by behavioral health conditions and social risk factors. The reviewers revised the NAM taxonomy to create a final framework, adding chronic pain and prior patterns of high health care use as characteristics associated with an increased risk for being HNHC. LIMITATION: Little evidence distinguished potentially preventable or modifiable health care use from overall use. CONCLUSION: A combination of characteristics can be useful for identifying HNHC patients. Because of the complexity of their conditions and circumstances, improving their quality of care will likely also require an individualized assessment of care needs and availability of support services. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality. (PROSPERO: CRD42020161179).

Unpacking complex interventions that manage care for high-need, high-cost patients: a realist review.

OBJECTIVE: Payers, providers and policymakers in the USA are interested in developing interventions that reduce preventable or modifiable healthcare use among high-need, high-cost (HNHC) patients. This study seeks to describe how and why complex interventions for HNHC patients lead to more appropriate use of healthcare services. DESIGN: A realist review which develops programme theories from causal explanations generated and articulated through the creation of context-mechanism-outcome configurations. METHODS: Electronic databases (including PubMed and Embase) and gray literature from January 2000 to March 2021 were searched. All study designs were included if the article provided data to develop our programme theories. Included studies were conducted in the USA and focused on interventions for adult, HNHC patients. RESULTS: Data were synthesised from 48 studies. Identifying HNHC patients for inclusion in interventions requires capturing a combination of characteristics including their prior use of healthcare services, complexity of chronic disease(s) profile, clinician judgment and willingness to participate. Once enrolled, engaging HNHC patients in interventions requires intervention care providers and patients to build a trusting relationship. Tailored, individualised assistance for medical and non-medical needs, emotional support and self-management education empowers patients to increase their participation in managing their own care. Engagement of care providers in interventions to expand support of HNHC patients is facilitated by targeted outreach, adequate staffing support with shared values and regular and open communication. CONCLUSIONS: Building relationships with HNHC patients and gaining their trust is a key component for interventions to successfully change HNHC patients' behaviors. Identifying HNHC patients for an intervention can be best achieved through a multipronged strategy that accounts for their clinical and psychosocial complexity and prior experiences with the healthcare system. Successful interventions recognise that relationships with HNHC patients require the sustained engagement of care providers. To succeed, providers need ongoing emotional, financial, logistical and practical resources. PROSPERO REGISTRATION NUMBER: CRD42020161179.

Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Meta-Analysis of Pharmacotherapy.

Objective: The authors systematically reviewed evidence on pharmacotherapy for perinatal mental health disorders. Methods: The authors searched for studies of pregnant, postpartum, or reproductive-age women with mental health disorders treated with pharmacotherapy in MEDLINE, EMBASE, PsycINFO, the Cochrane Library, and trial registries from database inception through June 5, 2020 and surveilled literature through March 2, 2021. Outcomes included symptoms; functional capacity; quality of life; suicidal events; death; and maternal, fetal, infant, or child adverse events. Results: 164 studies were included. Regarding benefits, brexanolone for third-trimester or postpartum depression onset may be associated with improved depressive symptoms at 30 days when compared with placebo. Sertraline for postpartum depression may be associated with improved response, remission, and depressive symptoms when compared with placebo. Discontinuing mood stabilizers during pregnancy may be associated with increased recurrence of mood episodes for bipolar disorder. Regarding adverse events, most studies were observational and unable to fully account for confounding. Evidence on congenital and cardiac anomalies for treatment compared with no treatment was inconclusive. Brexanolone for depression onset in the third trimester or the postpartum period may be associated with risk of sedation or somnolence, leading to dose interruption or reduction when compared with placebo. Conclusions: Evidence from few studies supports the use of pharmacotherapy for perinatal mental health disorders. Although many studies report on adverse events, they could not rule out underlying disease severity as the cause of the association between exposures and adverse events. Patients and clinicians need to make informed, collaborative decisions on treatment choices.

Direct-to-Consumer Advertising of Prescription Drugs and the Patient-Prescriber Encounter: A Systematic Review.

We systematically reviewed the research on patients' and prescribers' perceptions of, and self-reported behaviors prompted by, exposure to direct-to-consumer advertising (DTCA) (For ease of reading we use the term "advertising" to encompass advertising and promotional labeling. Broad use of this term does not imply endorsement by FDA) of prescription drugs that occurs in the context of a clinical encounter. This research offers an important perspective on the broader goal of incorporating patient and prescriber voices in decision-making. Outcomes included patient information seeking, medication adherence, patient requests for DTCA-promoted prescription drugs, prescribing behaviors, and perceptions of the patient-prescriber relationship and interactions. We searched PubMed and other databases from 1982-2017 and identified 38 studies meeting our study criteria. Of these, 24 studies used patient-reported outcomes and 18 used prescriber-reported outcomes (four used both). Studies suggested some potential benefits of exposure to DTCA, including patients' enhanced information-seeking, increased patient requests for appropriate prescriptions (when addressing potential underuse) and patients' perceptions of higher-quality interactions with prescribers. Most prescribers perceived a neutral influence on the quality of their clinical interactions with patients regarding DTCA. Harms included patients receiving prescriptions for drugs that were not appropriate for them or that the patients did not need, and the potential for DTCA to interfere with medication adherence in some populations, such as those with mental illness. The potential benefits of DTCA on the patient-provider encounter must be balanced with the potential for harms.

Recommendations for assessing the risk of bias in systematic reviews of health-care interventions.

OBJECTIVES: Risk-of-bias assessment is a central component of systematic reviews, but little conclusive empirical evidence exists on the validity of such assessments. In the context of such uncertainty, we present pragmatic recommendations that promote transparency and reproducibility in processes, address methodological advances in the risk-of-bias assessment, and can be applied consistently across review topics. STUDY DESIGN AND SETTING: Epidemiological study design principles; available empirical evidence, risk-of-bias tools, and guidance; and workgroup consensus. RESULTS: We developed recommendations for assessing the risk of bias of studies of health-care interventions specific to framing the focus and scope of risk-of-bias assessment; selecting the risk-of-bias categories; choosing assessment instruments; and conducting, analyzing, and presenting results of risk-of-bias assessments. Key recommendations include transparency and reproducibility of judgments, separating risk of bias from other constructs such as applicability and precision, and evaluating the risk of bias per outcome. We recommend against certain past practices, such as focusing on reporting quality, relying solely on study design or numerical quality scores, and automatically downgrading for industry sponsorship. CONCLUSION: Risk-of-bias assessment remains a challenging but essential step in systematic reviews. We presented standards to promote transparency of judgments.

AHRQ series on complex intervention systematic reviews-paper 3: adapting frameworks to develop protocols.

BACKGROUND: Once a proposed topic has been identified for a systematic review and has undergone a question formulation stage, a protocol must be developed that specifies the scope and research questions in detail and outlines the methodology for conducting the systematic review. RATIONALE: Framework modifications are often needed to accommodate increased complexity. We describe and give examples of adaptations and alternatives to traditional analytic frameworks. DISCUSSION: This article identifies and describes elements of frameworks and how they can be adapted to inform the protocol and conduct of systematic reviews of complex interventions. Modifications may be needed to adapt the population, intervention, comparators, and outcomes normally used in protocol development to successfully describe complex interventions; in some instances, alternative frameworks may be better suited. Possible approaches to analytic frameworks for complex interventions that illustrate causal and associative linkages are outlined, including time elements, which systematic reviews of complex interventions may need to address. The need for and specifics of the accommodations vary with details of a specific systematic review. This in turn helps determine whether traditional frameworks are sufficient, can be refined, or if alternate frameworks must be adopted.

Comparative Effectiveness of Treatments for Binge-Eating Disorder: Systematic Review and Network Meta-Analysis.

Psychological and pharmacological interventions for binge-eating disorder have previously demonstrated efficacy (compared with placebo or waitlist control); thus, we aimed to expand that literature with a review of comparative effectiveness. We searched MEDLINE,® EMBASE,® Cochrane Library, Academic OneFile, CINAHL® for binge-eating disorder treatment articles and selected studies using predetermined inclusion and exclusion criteria. Data were sufficient for network meta-analysis comparing two pharmacological interventions; psychological interventions were analysed qualitatively. In all, 28 treatment comparisons were included in this review: one pharmacological comparison (second-generation antidepressants versus lisdexamfetamine) and 26 psychological comparisons. Only three statistically significant differences emerged: lisdexamfetamine was better at increasing binge abstinence than second-generation antidepressants; therapist-led cognitive behavioural therapy was better at reducing binge-eating frequency than behavioural weight loss, but behavioural weight loss was better at reducing weight. The majority of other treatment comparisons revealed few significant differences between groups. Thus, patients and clinicians can choose from several effective treatment options. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.

Binge-Eating Disorder in Adults: A Systematic Review and Meta-analysis.

BACKGROUND: The best treatment options for binge-eating disorder are unclear. PURPOSE: To summarize evidence about the benefits and harms of psychological and pharmacologic therapies for adults with binge-eating disorder. DATA SOURCES: English-language publications in EMBASE, the Cochrane Library, Academic OneFile, CINAHL, and ClinicalTrials.gov through 18 November 2015, and in MEDLINE through 12 May 2016. STUDY SELECTION: 9 waitlist-controlled psychological trials and 25 placebo-controlled trials that evaluated pharmacologic (n = 19) or combination (n = 6) treatment. All were randomized trials with low or medium risk of bias. DATA EXTRACTION: 2 reviewers independently extracted trial data, assessed risk of bias, and graded strength of evidence. DATA SYNTHESIS: Therapist-led cognitive behavioral therapy, lisdexamfetamine, and second-generation antidepressants (SGAs) decreased binge-eating frequency and increased binge-eating abstinence (relative risk, 4.95 [95% CI, 3.06 to 8.00], 2.61 [CI, 2.04 to 3.33], and 1.67 [CI, 1.24 to 2.26], respectively). Lisdexamfetamine (mean difference [MD], -6.50 [CI, -8.82 to -4.18]) and SGAs (MD, -3.84 [CI, -6.55 to -1.13]) reduced binge-eating-related obsessions and compulsions, and SGAs reduced symptoms of depression (MD, -1.97 [CI, -3.67 to -0.28]). Headache, gastrointestinal upset, sleep disturbance, and sympathetic nervous system arousal occurred more frequently with lisdexamfetamine than placebo (relative risk range, 1.63 to 4.28). Other forms of cognitive behavioral therapy and topiramate also increased abstinence and reduced binge-eating frequency and related psychopathology. Topiramate reduced weight and increased sympathetic nervous system arousal, and lisdexamfetamine reduced weight and appetite. LIMITATIONS: Most study participants were overweight or obese white women aged 20 to 40 years. Many treatments were examined only in single studies. Outcomes were measured inconsistently across trials and rarely assessed beyond end of treatment. CONCLUSION: Cognitive behavioral therapy, lisdexamfetamine, SGAs, and topiramate reduced binge eating and related psychopathology, and lisdexamfetamine and topiramate reduced weight in adults with binge-eating disorder. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Twelve recommendations for integrating existing systematic reviews into new reviews: EPC guidance.

OBJECTIVES: As time and cost constraints in the conduct of systematic reviews increase, the need to consider the use of existing systematic reviews also increases. We developed guidance on the integration of systematic reviews into new reviews. METHODS: A workgroup of methodologists from Evidence-based Practice Centers developed consensus-based recommendations. Discussions were informed by a literature scan and by interviews with organizations that conduct systematic reviews. RESULTS: Twelve recommendations were developed addressing selecting reviews, assessing risk of bias, qualitative and quantitative synthesis, and summarizing and assessing body of evidence. CONCLUSIONS: We provide preliminary guidance for an efficient and unbiased approach to integrating existing systematic reviews with primary studies in a new review.

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.

Grading the strength of a body of evidence when assessing health care interventions: an EPC update.

OBJECTIVES: To revise 2010 guidance on grading the strength of evidence (SOE) of the effectiveness of drugs, devices, and other preventive and therapeutic interventions in systematic reviews produced by the Evidence-based Practice Center (EPC) program, established by the US Agency for Healthcare Research and Quality (AHRQ). STUDY DESIGN AND SETTING: A cross-EPC working group reviewed authoritative systems for grading SOE [primarily the approach from the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group] and conducted extensive discussions with GRADE and other experts. RESULTS: Updated guidance continues to be conceptually similar to GRADE. Reviewers are to evaluate SOE separately for each major treatment comparison for each major outcome. We added reporting bias as a required domain and retained study limitations (risk of bias), consistency, directness, and precision (and three optional domains). Additional guidance covers scoring consistency, precision, and reporting bias, grading bodies of evidence with randomized controlled trials and observational studies, evaluating single study bodies of evidence, using studies with high risk of bias, and presenting findings with greater clarity and transparency. SOE is graded high, moderate, low, or insufficient, reflecting reviewers' confidence in the findings for a specific treatment comparison and outcome. CONCLUSION: No single approach for grading SOE suits all reviews, but a more consistent and transparent approach to reporting summary information will make reviews more useful to the broad range of audiences that AHRQ's work aims to reach. EPC working groups will consider ongoing challenges and modify guidance as needed, on issues such as combining trials and observational studies in bodies of evidence, weighting domains, and combining qualitative and quantitative syntheses.

Quality assessment of observational studies in a drug-safety systematic review, comparison of two tools: the Newcastle-Ottawa Scale and the RTI item bank.

BACKGROUND: The study objective was to compare the Newcastle-Ottawa Scale (NOS) and the RTI item bank (RTI-IB) and estimate interrater agreement using the RTI-IB within a systematic review on the cardiovascular safety of glucose-lowering drugs. METHODS: We tailored both tools and added four questions to the RTI-IB. Two reviewers assessed the quality of the 44 included studies with both tools, (independently for the RTI-IB) and agreed on which responses conveyed low, unclear, or high risk of bias. For each question in the RTI-IB (n=31), the observed interrater agreement was calculated as the percentage of studies given the same bias assessment by both reviewers; chance-adjusted interrater agreement was estimated with the first-order agreement coefficient (AC1) statistic. RESULTS: The NOS required less tailoring and was easier to use than the RTI-IB, but the RTI-IB produced a more thorough assessment. The RTI-IB includes most of the domains measured in the NOS. Median observed interrater agreement for the RTI-IB was 75% (25th percentile [p25] =61%; p75 =89%); median AC1 statistic was 0.64 (p25 =0.51; p75 =0.86). CONCLUSION: The RTI-IB facilitates a more complete quality assessment than the NOS but is more burdensome. The observed agreement and AC1 statistic in this study were higher than those reported by the RTI-IB's developers.

Integration of existing systematic reviews into new reviews: identification of guidance needs.

BACKGROUND: An exponential increase in the number of systematic reviews published, and constrained resources for new reviews, means that there is an urgent need for guidance on explicitly and transparently integrating existing reviews into new systematic reviews. The objectives of this paper are: 1) to identify areas where existing guidance may be adopted or adapted, and 2) to suggest areas for future guidance development. METHODS: We searched documents and websites from healthcare focused systematic review organizations to identify and, where available, to summarize relevant guidance on the use of existing systematic reviews. We conducted informational interviews with members of Evidence-based Practice Centers (EPCs) to gather experiences in integrating existing systematic reviews, including common issues and challenges, as well as potential solutions. RESULTS: There was consensus among systematic review organizations and the EPCs about some aspects of incorporating existing systematic reviews into new reviews. Current guidance may be used in assessing the relevance of prior reviews and in scanning references of prior reviews to identify studies for a new review. However, areas of challenge remain. Areas in need of guidance include how to synthesize, grade the strength of, and present bodies of evidence composed of primary studies and existing systematic reviews. For instance, empiric evidence is needed regarding how to quality check data abstraction and when and how to use study-level risk of bias assessments from prior reviews. CONCLUSIONS: There remain areas of uncertainty for how to integrate existing systematic reviews into new reviews. Methods research and consensus processes among systematic review organizations are needed to develop guidance to address these challenges.