Katrina E Donahue

Low health literacy and health outcomes: an updated systematic review.

BACKGROUND Approximately 80 million Americans have limited health literacy, which puts them at greater risk for poorer access to care and poorer health outcomes. PURPOSE To update a 2004 systematic review and determine whether low health literacy is related to poorer use of health care, outcomes, costs, and disparities in health outcomes among persons of all ages. DATA SOURCES English-language articles identified through MEDLINE, CINAHL, PsycINFO, ERIC, and Cochrane Library databases and hand-searching (search dates for articles on health literacy, 2003 to 22 February 2011; for articles on numeracy, 1966 to 22 February 2011). STUDY SELECTION Two reviewers independently selected studies that compared outcomes by differences in directly measured health literacy or numeracy levels. DATA EXTRACTION One reviewer abstracted article information into evidence tables; a second reviewer checked information for accuracy. Two reviewers independently rated study quality by using predefined criteria, and the investigative team jointly graded the overall strength of evidence. DATA SYNTHESIS 96 relevant good- or fair-quality studies in 111 articles were identified: 98 articles on health literacy, 22 on numeracy, and 9 on both. Low health literacy was consistently associated with more hospitalizations; greater use of emergency care; lower receipt of mammography screening and influenza vaccine; poorer ability to demonstrate taking medications appropriately; poorer ability to interpret labels and health messages; and, among elderly persons, poorer overall health status and higher mortality rates. Poor health literacy partially explains racial disparities in some outcomes. Reviewers could not reach firm conclusions about the relationship between numeracy and health outcomes because of few studies or inconsistent results among studies. LIMITATIONS Searches were limited to articles published in English. No Medical Subject Heading terms exist for identifying relevant studies. No evidence concerning oral health literacy (speaking and listening skills) and outcomes was found. CONCLUSION Low health literacy is associated with poorer health outcomes and poorer use of health care services. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Systematic Review: Comparative Effectiveness and Harms of Disease-Modifying Medications for Rheumatoid Arthritis

Context Which disease-modifying antirheumatic drugs (DMARDs) best reduce symptoms, improve function, and prevent radiographic progression in patients with rheumatoid arthritis? Contribution This systematic review of trials that compared DMARDs in adults with rheumatoid arthritis found few direct comparisons of different agents but no important differences among synthetic DMARDs or antitumor necrosis factor drugs. Combination therapy improved response rates and functional outcomes in patients whose monotherapy failed. Numbers and types of short-term adverse events were similar among DMARDs. Implication Of several monotherapies for adults with rheumatoid arthritis, no regimen is clearly superior. Combination therapies improve response rates in some patients previously receiving monotherapy. The Editors Rheumatoid arthritis is an autoimmune disease that affects more than 2 million adults in the United States. Disease onset generally occurs between 30 and 55 years of age, and women are affected more often than men. Disease hallmarks are inflammation of the synovium, progressive bone erosion, joint malalignment and destruction, and subsequent weakness of surrounding tissues and muscles. Presentations range from mild to severe, although the typical patient has a progressive course leading to functional limitations. Treatment aims at controlling pain and inflammation and slowing or arresting the progression of joint destruction. Therapies generally used in the United States include corticosteroids; synthetic disease-modifying antirheumatic drugs (DMARDs), such as hydroxychloroquine, leflunomide, methotrexate, and sulfasalazine; and biological DMARDs, such as abatacept, adalimumab, anakinra, etanercept, infliximab, and rituximab. The American College of Rheumatology (ACR) recommends beginning DMARD therapy within 3 months of diagnosis (1). Often, treatment with a single DMARD does not adequately control symptoms, leading clinicians to consider various combination strategies. Experts do not agree about the comparative benefits of different combination therapies. Many questions remain about the risks of these agents across a spectrum of adverse events from relatively minor side effects to severe and possibly life-threatening problems. Given this uncertainty, the Agency for Healthcare Research and Quality (AHRQ) commissioned a systematic review to compare the benefits and safety of rheumatoid arthritis drugs (2). Methods We developed and followed a standardized protocol for all steps of the review. The full technical report (2) describes study methods in detail and gives evidence tables of individual studies. Literature Search We searched MEDLINE, EMBASE, The Cochrane Library, and the International Pharmaceutical Abstracts for studies from 1980 to September 2007. Search terms included Medical Subject Headings or keywords when appropriate. We combined terms for rheumatoid arthritis with 11 drugs of interest (corticosteroid, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, etanercept, infliximab, adalimumab, abatacept, anakinra, and rituximab). We limited electronic searches to studies involving adults and humans and studies in English. We manually searched reference lists of review articles and letters to the editor. In addition, we searched the Center for Drug Evaluation and Research database (September 2007) to identify unpublished research submitted to the U.S. Food and Drug Administration. In early to mid-2006, the Oregon Scientific Resource Center invited pharmaceutical manufacturers to submit dossiers on all published and unpublished studies on a specific drug. Five companies (Abbott, Amgen, Bristol-Myers Squibb, Centocor, and Genentech) provided dossiers. Study Selection Two persons, each blinded to the others results, independently reviewed titles, abstracts, and sometimes full text to identify studies meeting preestablished criteria. To assess efficacy regarding symptoms, quality of life, functional capacity, and radiographic progression, we included head-to-head controlled trials and prospective cohort studies comparing any of the therapies. For harms (specific adverse events, rates of adverse events, and discontinuation attributable to adverse events) and subgroups, we also examined data from retrospective observational studies and placebo-controlled trials. For efficacy and harm data, we selected studies with 100 or more participants and at least 12 weeks of follow-up. Finally, if we found no evidence about efficacy from direct head-to-head comparison studies, we included evidence from fair- or good-quality meta-analyses that indirectly compared placebo-controlled trial data across drugs. Data Abstraction and Quality Assessment Trained reviewers abstracted each study by using a Web-based system (SRS 4.0, TrialStat, Ottawa, Ontario, Canada). A senior reviewer read each abstracted article and evaluated completeness of data extraction. We recorded intention-to-treat results if available. We assessed the internal validity (quality) of trials on the basis of predefined criteria from the U.S. Preventive Services Task Force (rating of good, fair, or poor) (3) and the National Health Service Centre for Reviews and Dissemination (4). Elements of internal validity for trials included randomization, allocation concealment, similarity of compared groups at baseline, intention-to-treat analysis, and overall and differential loss to follow-up. To assess the quality of observational studies, we used criteria outlined by Deeks and colleagues (5). Items assessed included sample selection, adjustment for confounders, methods of outcomes assessment, length of follow-up, and statistical analysis. Data Synthesis We primarily synthesized the literature qualitatively; we reported some quantitative syntheses from fair- to good-quality meta-analyses. Drug comparisons that were not quantitatively analyzed in meta-analyses had insufficient data or noncomparable study samples and did not merit additional quantitative analyses. We examined data within 3 main drug classes (corticosteroids, synthetic DMARDs, and biological DMARDs) and between drug classes and combination therapies. Strength of Evidence Ratings We rated the strength of the available evidence in a 3-part hierarchy (high, moderate, and low) (2) based on a modified Grading of Recommendations, Assessment, Development, and Evaluation approach (6, 7). Grades reflect the strength of evidence for a given comparison with respect to specific outcomes, such as 20% improvement in ACR response criteria (ACR 20), radiographic changes, or adverse events. Role of the Funding Source Agency for Healthcare Research and Quality staff participated in formulating initial study questions and reviewed methods, data analysis, and the draft report. The funding source did not participate in the literature search, determination of study eligibility, or evaluation of individual studies. Results Characteristics of Reviewed Studies We identified 2395 citations (Figure). Working from 635 articles retrieved for full review, we included 143 published articles reporting on 101 studies (Table 1). Of the 101 included studies, 49 (48.5%) were supported by pharmaceutical companies, 20 (19.8%) by governmental or independent funds, and 11 (10.9%) by a combination of pharmaceutical and governmental funding. We could not determine the source of support for 21 (20.8%) studies. Table 1. Summary of Head-to-Head Reviewed Studies, by Drug Comparison* Figure. Study flow diagram. Numbers of included articles and included studies differ because some studies have multiple publications. RCT = randomized, controlled trial. Comparative Effectiveness and Harms We found few fair- or good-quality head-to-head trials for each drug comparison (Table 1). Most trials were efficacy trials in highly selected populations with few comorbid conditions. Most trials used ACR 20, disease activity scores to measure clinical improvement, and Sharp or Sharpvan der Heijde scores to measure radiologic progression of the disease. Trials examining quality of life used the Health Assessment Questionnaire (HAQ) or Medical Outcomes Study Short Form 36 (SF-36). Table 2 summarizes results. Table 2. Summary of Comparative Findings on Efficacy and Harms of Rheumatoid Arthritis Drugs Monotherapy versus Monotherapy Synthetic DMARDs One good systematic review that included a meta-analysis of 2 trials suggested that more patients receiving methotrexate achieved ACR 20 at 1 year than did patients receiving leflunomide (odds ratio, 1.43 [95% CI, 1.15 to 1.77]). The ACR 20 benefit was lower and more uncertain at 2 years (odds ratio, 1.28 [CI, 0.98 to 1.67]) (8). However, patients receiving methotrexate showed less improvement in health-related quality of life than did patients receiving leflunomide (odds ratio for SF-36 physical component, 3.00 [CI, 5.41 to 0.59]). Radiographic outcomes over 2 years seemed similar. For leflunomide versus sulfasalazine, data are limited to 1 trial (9) involving 358 participants with 2-year follow-up (10, 11). Leflunomide yielded more patients achieving ACR 20, ACR 50, and greater improvement in functional capacity (ACR 20, 82% vs. 60% [P= 0.008]; ACR 50, 52% vs. 25% [P= 0.040]; HAQ, 0.50 vs. 0.29 [P 0.030]). Radiographic changes were similar for the 2 drugs (Larsen score change at 2 years, 0.010 for either drug) (9). Three trials involving 479 participants and lasting up to 52 weeks compared methotrexate with sulfasalazine and found similar response rates in ACR 20, disease activity scores, or functional capacity (1214). Two trials included patients with disease for longer than 1 year and used a lower dose of weekly methotrexate (7.5 mg) than that generally used in the United States (13, 14). The overall attrition rate for these studies ranged from 19% to 28.5%. We found no statistically significant differences in frequency of serious adverse events for leflunomide, methotrexate, and sulfasalazine in 3 efficacy trial

Interventions for Individuals with Low Health Literacy: A Systematic Review

The U.S. Department of Health and Human Services recently called for action on health literacy. An important first step is defining the current state of the literature about interventions designed to mitigate the effects of low health literacy. We performed an updated systematic review examining the effects of interventions that authors reported were specifically designed to mitigate the effects of low health literacy. We searched MEDLINE®, The Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Educational Resources Information Center (ERIC), and the Cochrane Library databases (2003 forward for health literacy; 1966 forward for numeracy). Two reviewers independently reviewed titles, abstracts, and full-text articles for inclusion and included studies that examined outcomes by health literacy level and met other pre-specified criteria. One reviewer abstracted article information into evidence tables; a second checked accuracy. Two reviewers independently rated study quality using predefined criteria. Among 38 included studies, we found multiple discrete design features that improved comprehension in one or a few studies (e.g., presenting essential information by itself or first, presenting information so that the higher number is better, adding icon arrays to numerical information, adding video to verbal narratives). In a few studies, we also found consistent, direct, fair or good-quality evidence that intensive self-management interventions reduced emergency department visits and hospitalizations; and intensive self- and disease-management interventions reduced disease severity. Evidence for the effects of interventions on other outcomes was either limited or mixed. Multiple interventions show promise for mitigating the effects of low health literacy and could be considered for use in clinical practice.

Screening for type 2 diabetes mellitus: A cost-effectiveness analysis

Context In 2003, the U.S. Preventive Services Task Force recommended screening for type 2 diabetes in adults with hypertension or hyperlipidemia. The economic implications of this recommendation are unclear. Contribution Diabetes screening for 55-year-old hypertensive persons would cost the U.S. health care system

Screening adults for type 2 diabetes: A review of the evidence for the U.S. Preventive Services Task Force

34 375 per quality-adjusted life-year gained. Expanding screening to all adults regardless of the presence of hypertension would cost an additional

Context Matters: The Experience of 14 Research Teams in Systematically Reporting Contextual Factors Important for Practice Change

360 966 per quality-adjusted life-year. Implications The cost-effectiveness of targeting diabetes screening to hypertensive adults older than 55 years of age is similar to the cost-effectiveness of many accepted health care interventions. Universal diabetes screening is far more costly. The Editors Although many adults who meet criteria for type 2 diabetes (hereafter, diabetes) have not been identified (1), screening for diabetes remains controversial (2-11). Direct evidence indicates that various treatments to reduce complications are effective among people with clinically detected diabetes (12-14), but no direct evidence tells us the magnitude of any further benefit from starting these treatments earlier, after detection by screening (15). In the absence of direct evidence, researchers have applied mathematical models of diabetes progression to the issue of screening. One analysis found that the cost per quality-adjusted life-year (QALY) gained by universal diabetes screening was lower for younger than for older people:

Bridging Primary Care Practices and Communities to Promote Healthy Behaviors

13 376 at age 25 to 34 years, increasing to

Screening for high blood pressure: a review of the evidence for the U.S. Preventive Services Task Force.

116 908 at age 55 to 64 years (16). This conclusion followed from the models focus on the provision of glycemic control after screening to prevent microvascular complications. The analysis did not consider treatments to reduce the risks for complications of cardiovascular disease (CVD). More recent research suggests that the benefits of CVD risk reduction may be substantial for people with diabetes. The Hypertension Optimal Treatment (HOT) trial found that the optimal blood pressure target is lower for people with hypertension and diabetes than for people with hypertension without diabetes (14). Other research supports the finding that intensive control of hypertension is beneficial among people with diabetes (15, 17-19). Because the benefit may be greater for older people (at greater risk for CVD), the conclusion of the previous analysis, that diabetes screening is most cost-effective among younger people, needs to be reconsidered. We performed a new cost-effectiveness analysis to compare universal diabetes screening (universal screening) and diabetes screening targeted to patients with hypertension (targeted screening). When an updated version of the model used in the previous analysis that includes benefits from intensive treatment of hypertension was applied, we estimated the incremental cost-effectiveness of these 2 strategies for people in different age groups. Our analysis considers a one-time opportunistic screening for men and women of all races and ethnicities. Methods The Model We used a Markov model of diabetes disease progression to simulate lifetime diabetes-related health care costs and QALYs for people with diabetes (Appendix Figure 1). Demographic characteristics of the simulated cohort are based on 1997 population estimates projected from the 1990 U.S. Census and data on the distribution of people with diabetes by hypertension, cholesterol level, and smoking status (20). As people progress through the simulation model from the onset of diabetes to death, they can develop 5 types of complications: nephropathy, neuropathy, retinopathy, coronary heart disease (CHD), and stroke. People can die of some of these complications or of other causes. The model includes transition probabilities between disease stages on each of the 5 complication paths. The basic model structure has been described previously (16, 21). Key model parameters are presented in the Appendix Tables 1 to 10. To incorporate screening into the model, we first added a screening module in which some patients with diabetes are identified earlier than they would usually have been in the absence of screening. Second, we made assumptions about the transition probabilities between disease stages from the onset of diabetes to the time of usual clinical diagnosis of diabetes on the basis of the knowledge that progression is relatively slow during this period (15). After clinical diagnosis, disease progression depends on the number of years after normal diagnosis. Screening allows for earlier diagnosis, which in turn allows for earlier treatment interventions, such as intensive glycemic control and intensive hypertension control. These interventions decrease the transition probabilities, thereby delaying or preventing progression to diabetes complications. Costs are incurred for screening and diagnostic testing; standard glycemic control and, if the person is hypertensive, standard hypertension control; interventions (intensive glycemic control and, if the person is hypertensive, intensive hypertension control); and complications over the remaining lifetime of each person with diabetes. The sum of these costs and the models estimate of the expected QALYs for each screening strategy are used to calculate the incremental cost-effectiveness ratio of screening relative to no screening. We discounted future costs and QALYs at a 3% annual rate. Costs are measured in 1997 U.S. dollars. Interventions We assumed that, in the absence of screening, diabetes would be diagnosed 10 years after its onset (15). With one-time opportunistic screening, diabetes would be diagnosed on average 5 years after onset and therefore patients would begin treatment 5 years earlier. After diabetes diagnosis, all patients are treated with intensive glycemic control and, if they have hypertension, with intensive hypertension control. With targeted screening, only people with hypertension are screened. Those who screen positive and receive a diagnosis of diabetes begin intensive glycemic control and intensive hypertensive control 5 years earlier than they would in the absence of screening. With universal screening, all people, regardless of hypertension status, are screened. Those who screen positive and receive a diagnosis of diabetes begin intensive glycemic control 5 years earlier than in the absence of screening and begin intensive hypertension control 5 years earlier if they have hypertension. We defined hypertension as a blood pressure of 140/90 mm Hg or higher. We assumed that 19% of people age 25 to 44 years, 47% of people age 45 to 64 years, and 60% of people age 65 to 74 years had hypertension and therefore were included in targeted screening (20). Treatment of hypertension is modeled as standard (with a target diastolic blood pressure of 90 mm Hg) or intensive (with a target diastolic blood pressure of 80 mm Hg), as in the HOT trial (14). All persons with hypertension receive standard hypertension treatment until they receive a diagnosis of diabetes, after which they receive intensive hypertension treatment. The incremental cost of intensive hypertension control relative to standard control is

A Comparison of Live Counseling With a Web-Based Lifestyle and Medication Intervention to Reduce Coronary Heart Disease Risk A Randomized Clinical Trial

149 per year. In the HOT trial, the relative risk reduction for CHD events (fatal and nonfatal myocardial infarction) was 51%, and the relative risk reduction for stroke was about 30%. Although neither of these separate relative risk reductions was statistically significant, the relative risk reduction (51%) for the aggregate outcome of major CVD events was statistically significant (P = 0.005). We initially modeled the relative risk reduction for CHD events for intensive hypertension control to be 51%, with no risk reduction for stroke. We conducted a sensitivity analysis that included a 30% relative risk reduction for stroke on the basis of other studies showing that intensive hypertension control reduces risk among people with diabetes (17, 19). Model estimates of the effects of glycemic control are based on the United Kingdom Prospective Diabetes Study (UKPDS), a 10-year randomized, controlled trial of intensive versus conventional glycemic control (12). On the basis of the UKPDS, the reduction in hemoglobin A1c from intensive glycemic treatment is modeled as slowing the progression of microvascular complications (12). The incremental cost of intensive glycemic control (relative to standard control) ranges from

Infrastructure for large‐scale quality‐improvement projects: Early lessons from North Carolina improving performance in practice

900 to