Halle R Amick

Review: Conceptualization and Measurement of Organizational Readiness for Change A Review of the Literature in Health Services Research and Other Fields

Health care practitioners and change experts contend that organizational readiness for change is a critical precursor to successful change implementation. This article assesses how organizational readiness for change has been defined and measured in health services research and other fields. Analysis of 106 peer-reviewed articles reveals conceptual ambiguities and disagreements in current thinking and writing about organizational readiness for change. Inspection of 43 instruments for measuring organizational readiness for change reveals limited evidence of reliability or validity for most publicly available measures. Several conceptual and methodological issues that need to be addressed to generate knowledge useful for practice are identified and discussed.Health care practitioners and change experts contend that organizational readiness for change is a critical precursor to successful change implementation. This article assesses how organizational readiness for change has been defined and measured in health services research and other fields. Analysis of 106 peer-reviewed articles reveals conceptual ambiguities and disagreements in current thinking and writing about organizational readiness for change. Inspection of 43 instruments for measuring organizational readiness for change reveals limited evidence of reliability or validity for most publicly available measures. Several conceptual and methodological issues that need to be addressed to generate knowledge useful for practice are identified and discussed.

Screening for Asymptomatic Carotid Artery Stenosis: A Systematic Review and Meta-analysis for the U.S. Preventive Services Task Force

Stroke is a leading cause of death and disability (1). An estimated 7 million U.S. adults have had a stroke, and roughly 75% were first attacks (2). Ischemic strokes account for nearly 90% of all strokes in the United States (3). Carotid artery stenosis (CAS) causes approximately 10% of ischemic strokes (4). Carotid artery stenosis refers to atherosclerotic narrowing of the extracranial carotid arteriesspecifically, the internal carotid arteries or the common and internal carotid arteries. The best available data for the prevalence of asymptomatic CAS from large U.S.-based studies of the general population were published in the 1990s and enrolled adults aged 65 years or older (5, 6). Data published in 1992 showed a prevalence of just more than 1% for CAS of 75% to 99% (6), and those published in 1998 suggested a prevalence of 0.5% for CAS of 70% to 99% (5). Several studies have attempted to estimate the rate of progression of asymptomatic CAS and predict neurologic events (5, 711). The best available data from large U.S.-based studies of the general population revealed a 5-year risk for ipsilateral stroke of 5% for CAS of 70% or greater (5441 participants) (5). The main purpose of this review is to evaluate the current evidence on whether screening asymptomatic adults for CAS reduces the risk for ipsilateral stroke and on harms associated with screening and interventions for CAS. We also evaluated evidence on the incremental benefit of medical therapy and on risk-stratification tools. Despite a D recommendation from the U.S. Preventive Services Task Force in 2007 (12), many surgeries or interventions for asymptomatic CAS continue to be performed, and free or cash-on-the-barrel screenings are offered in public locations across the country (13). Methods We developed an analytic framework (Supplement 1) and key questions (Table 1 of Supplement 2) that guided the review. Detailed methods and additional results are publicly available in our full evidence report (www.uspreventiveservicestaskforce.org) (14). Supplement 1. Analytic Framework for Screening for Asymptomatic Carotid Artery Stenosis Supplement 2. Tables Data Sources and Searches We searched MEDLINE, the Cochrane Library, and EMBASE for English-language articles published through September 2013 (Tables 2 and 3 of Supplement 2). We conducted a targeted update search of MEDLINE for trials published through 31 March 2014 and searched clinical trial registries for unpublished literature. To supplement electronic searches, we reviewed reference lists of included studies and literature suggested by reviewers. Study Selection Two investigators independently reviewed abstracts and full-text articles against prespecified eligibility criteria (Table 4 of Supplement 2). We included studies that focused on asymptomatic adults with CAS and studies that analyzed the asymptomatic group separately. We included randomized, controlled trials (RCTs) of screening for CAS, RCTs and systematic reviews of treatment effectiveness, multi-institution trials or cohort studies that reported harms, and studies that attempted to externally validate risk-stratification tools. For evaluation of accuracy and reliability of ultrasonography, we focused on systematic reviews but also included primary studies that were published after the literature search cutoff of the most recent good-quality systematic review. Data Extraction and Quality Assessment One investigator extracted pertinent information from each article. Another investigator reviewed extractions for completeness and accuracy. Two independent investigators assigned quality ratings (good, fair, or poor) for each study using predefined criteria (14, 15). Disagreements were resolved with team discussion. Poor-quality studies are described in the full report (14). Data Synthesis and Analysis We qualitatively synthesized findings for each key question by summarizing the characteristics and results of included studies in tabular or narrative format. To determine whether meta-analyses were appropriate, we assessed the clinical and methodological heterogeneity of the studies following established guidance (16). We conducted meta-analysis of RCTs that compared carotid endarterectomy (CEA) with medical therapy for relevant outcomes reported by several studies. We used DerSimonianLaird random-effects models to estimate pooled effects (17) and calculated risk differences between CEA and medical therapy to show the absolute differences between groups. Absolute measures are more easily interpreted, show more directly relevant information, and better allow decision makers to assess tradeoffs between benefits and harms (1820). We calculated chi-square and I 2 statistics to assess statistical heterogeneity in effects among studies (21, 22). To allow the comparison of rates of perioperative harms reported in RCTs with those from sources that may be more representative of real-world clinical practice, we conducted meta-analyses of cohort studies that reported perioperative (30-day) stroke or death rates. We also conducted meta-analyses of such rates reported in trials that involved CEA or carotid angioplasty and stenting (CAAS), regardless of the comparator. We conducted sensitivity analyses using profile likelihood random-effects methods when our meta-analyses included few studies (2326). We did not include poor-quality studies in our analyses. Analyses were conducted using Stata, version 11.1 (StataCorp). Role of the Funding Source The Agency for Healthcare Research and Quality funded the review. Members of the U.S. Preventive Services Task Force and Agency for Healthcare Research and Quality assisted in developing the reviews scope and reviewed draft manuscripts, but the authors are solely responsible for the content. Results We included 78 published articles that reported on 56 studies (Figure 1) . Figure 1. Summary of evidence search and selection. WHO ICTRP = World Health Organization International Clinical Trials Registry Platform. Direct Evidence that Screening Reduces Ipsilateral Stroke We found no eligible studies that provided evidence on whether screening reduced ipsilateral stroke. Accuracy and Reliability of Duplex Ultrasonography We included 3 meta-analyses (2729) and 1 fair-quality primary study (30) (Table 5 of Supplement 2). The most recent good-quality meta-analysis (28) included 47 studies published through 2003 that used digital subtraction angiography as the reference standard. It reported sensitivity and specificity for detecting stenosis of 50% or greater (1716 participants) of 98% (95% CI, 97% to 100%) and 88% (CI, 76% to 100%), respectively. Sensitivity and specificity for detecting stenosis of 70% or greater (2140 participants) were 90% (CI, 84% to 94%) and 94% (CI, 88% to 97%). Using data from this meta-analysis, the last evidence report for the U.S. Preventive Services Task Force estimated the sensitivity and specificity for detecting stenosis of 60% or greater as 94% and 92%, respectively (31). The meta-analysis reported wide, clinically important variation in measurement properties among laboratories (28). The findings of the other meta-analyses were generally consistent with these results, but specificity in the primary study was lower (66% for detecting CAS of 70% to 99% [CI, 63% to 71%]; 503 participants) (30). Additional results are provided in our full report (14). Benefits of CEA or CAAS Beyond Medical Therapy We included 3 RCTs (Table 1) described in 12 publications (3243) that compared CEA with medical therapy and 3 systematic reviews described in 5 publications (31, 4447). We found no eligible studies that compared CAAS with medical therapy and no studies that compared CEA with current standard medical therapy. Table 1. Characteristics and Main Results of Included Fair- or Good-Quality Randomized, Controlled Trials of CEA Compared With MM for Asymptomatic CAS* The ACAS (Asymptomatic Carotid Atherosclerosis Study) and the VACS (Veterans Affairs Cooperative Study) were conducted in North America; the ACST (Asymptomatic Carotid Surgery Trial) involved 30 countries, primarily in Europe. Medical therapy varied across trials and was often not clearly defined or standardized. Surgeons with a history of low complication rates were selected. They submitted records of their last 50 cases or previous 24 months of experience with CEA and were selected on the basis of review by a committee or morbidity and mortality rates less than 3%. Our meta-analyses found that fewer persons treated with CEA had perioperative stroke or death or subsequent ipsilateral stroke, perioperative stroke or death or any subsequent stroke, any stroke or death, nonperioperative ipsilateral stroke, and any nonperioperative stroke than those in medical therapy groups (Table 2 and Figure 2). For all-cause mortality, we found no significant difference. Results for sensitivity analyses using profile likelihood methods were very similar to those of our main analyses, with only minor variation in width of CIs (Table 2). Table 2. Summary of Main Results of Meta-analyses Figure 2. Meta-analyses of randomized, controlled trials comparing CEA with medical therapy, by outcome. ACAS = Asymptomatic Carotid Atherosclerosis Study; ACST = Asymptomatic Carotid Surgery Trial; CEA = carotid endarterectomy; MM = medical management; RD = risk difference; VACS = Veterans Affairs Cooperative Study. In the ACST, more than one half (57.8% [166 of 287]) of nonperioperative strokes were disabling or fatal, and the proportional reduction in disabling or fatal stroke (relative risk, 0.61 [CI, 0.41 to 0.92]) was similar to that for any stroke (relative risk, 0.54 [CI, 0.43 to 0.68]) (37). Subgroup analyses of the ACAS showed a statistically significant reduction for men (relative risk reduction, 66% [CI, 36% to 82%]) but not for women (relative risk reduction, 17% [CI, 96% to 65%]) for estimated 5-year rate of perioperative stroke or death and subsequent ipsilateral stroke.

Implementing the Community Health Worker Model Within Diabetes Management Challenges and Lessons Learned From Programs Across the United States

Purpose The purpose of this qualitative study was to examine methods of implementation of the community health worker (CHW) model within diabetes programs, as well as related challenges and lessons learned. Methods Semi-structured interviews were conducted with program managers. Four databases (PubMed, CINAHL, ISI Web of Knowledge, PsycInfo), the CDCs 1998 directory of CHW programs, and Google Search Engine were used to identify CHW programs. Criteria for inclusion were: DM program; used CHW strategy; occurred in United States. Two independent reviewers performed content analyses to identify major themes and findings. Sixteen programs were assessed, all but 3 focused on minority populations. Most CHWs were recruited informally; 6 programs required CHWs to have diabetes. Results CHW roles and responsibilities varied across programs; educator was the most commonly identified role. Training also varied in terms of both content and intensity. All programs gave CHWs remuneration for their work. Common challenges included difficulties with CHW retention, intervention fidelity and issues related to sustainability. Cultural and gender issues also emerged. Examples of lessons learned included the need for community buy-in and the need to anticipate nondiabetes related issues. Conclusions Lessons learned from these programs may be useful to others as they apply the CHW model to diabetes management within their own communities. Further research is needed to elucidate the specific features of this model necessary to positively impact health outcomes.

Review: Use of Qualitative Methods in Published Health Services and Management Research: A 10-Year Review

Over the past 10 years, the field of health services and management research has seen renewed interest in the use of qualitative research methods. This article examines the volume and characteristics of qualitative research articles published in nine major health services and management journals between 1998 and 2008. Qualitative research articles comprise 9% of research articles published in these journals. Although the publication rate of qualitative research articles has not kept pace with that of quantitative research articles, citation analysis suggests that qualitative research articles contribute comparably to the field’s knowledge base. A wide range of policy and management topics has been examined using qualitative methods. Case study designs, interviews, and documentary sources were the most frequently used methods. Half of qualitative research articles provided little or no detail about key aspects the study’s methods. Implications are discussed and recommendations are offered for promoting the publication of qualitative research.

Screening for Obstructive Sleep Apnea in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force

Importance Many adverse health outcomes are associated with obstructive sleep apnea (OSA). Objective To review primary care–relevant evidence on screening adults for OSA, test accuracy, and treatment of OSA, to inform the US Preventive Services Task Force. Data Sources MEDLINE, Cochrane Library, EMBASE, and trial registries through October 2015, references, and experts, with surveillance of the literature through October 5, 2016. Study Selection English-language randomized clinical trials (RCTs); studies evaluating accuracy of screening questionnaires or prediction tools, diagnostic accuracy of portable monitors, or association between apnea-hypopnea index (AHI) and health outcomes among community-based participants. Data Extraction and Synthesis Two investigators independently reviewed abstracts and full-text articles. When multiple similar studies were available, random-effects meta-analyses were conducted. Main Outcomes and Measures Sensitivity, specificity, area under the curve (AUC), AHI, Epworth Sleepiness Scale (ESS) scores, blood pressure, mortality, cardiovascular events, motor vehicle crashes, quality of life, and harms. Results A total of 110 studies were included (N = 46 188). No RCTs compared screening with no screening. In 2 studies (n = 702), the screening accuracy of the multivariable apnea prediction score followed by home portable monitor testing for detecting severe OSA syndrome (AHI ≥30 and ESS score >10) was AUC 0.80 (95% CI, 0.78 to 0.82) and 0.83 (95% CI, 0.77 to 0.90), respectively, but the studies oversampled high-risk participants and those with OSA and OSA syndrome. No studies prospectively evaluated screening tools to report calibration or clinical utility for improving health outcomes. Meta-analysis found that continuous positive airway pressure (CPAP) compared with sham was significantly associated with reduction of AHI (weighted mean difference [WMD], −33.8 [95% CI, −42.0 to −25.6]; 13 trials, 543 participants), excessive sleepiness assessed by ESS score (WMD, −2.0 [95% CI, −2.6 to −1.4]; 22 trials, 2721 participants), diurnal systolic blood pressure (WMD, −2.4 points [95% CI, −3.9 to −0.9]; 15 trials, 1190 participants), and diurnal diastolic blood pressure (WMD, −1.3 points [95% CI, −2.2 to −0.4]; 15 trials, 1190 participants). CPAP was associated with modest improvement in sleep-related quality of life (Cohen d, 0.28 [95% CI, 0.14 to 0.42]; 13 trials, 2325 participants). Mandibular advancement devices (MADs) and weight loss programs were also associated with reduced AHI and excessive sleepiness. Common adverse effects of CPAP and MADs included oral or nasal dryness, irritation, and pain, among others. In cohort studies, there was a consistent association between AHI and all-cause mortality. Conclusions and Relevance There is uncertainty about the accuracy or clinical utility of all potential screening tools. Multiple treatments for OSA reduce AHI, ESS scores, and blood pressure. Trials of CPAP and other treatments have not established whether treatment reduces mortality or improves most other health outcomes, except for modest improvement in sleep-related quality of life.

Applying the Community Health Worker Model to Diabetes Management: Using Mixed Methods to Assess Implementation and Effectiveness

Introduction. The community health worker (CHW) model is a popular method for reaching vulnerable populations with diabetes. This study assessed implementation and effectiveness of the model within diabetes programs. Methods. Four databases were searched to identify diabetes programs implementing the CHW model. Corresponding articles were reviewed and semi-structured interviews were conducted with directors of each program. Results. Eight studies met inclusion criteria for review and their program managers were interviewed. Five CHW roles were identified: educator, case manager, role model, program facilitator, and advocate. Roles, responsibilities and training varied greatly across programs. Selected outcomes also varied, ranging from physiologic measures, to health behaviors, to measures of health care utilization and cost. Conclusions. Research regarding application of the community health worker model in diabetes management is limited and consensus regarding the scope of the CHW’s role is lacking. Future studies should rigorously examine how best to integrate this promising model into chronic disease management.

Comparative benefits and harms of second generation antidepressants and cognitive behavioral therapies in initial treatment of major depressive disorder: systematic review and meta-analysis

Study question What are the benefits and harms of second generation antidepressants and cognitive behavioral therapies (CBTs) in the initial treatment of a current episode of major depressive disorder in adults? Methods This was a systematic review including qualitative assessment and meta-analyses using random and fixed effects models. Medline, Embase, the Cochrane Library, the Allied and Complementary Medicine Database, PsycINFO, and the Cumulative Index to Nursing and Allied Health Literature were searched from January1990 through January 2015. The 11 randomized controlled trials included compared a second generation antidepressant CBT. Ten trials compared antidepressant monotherapy with CBT alone; three compared antidepressant monotherapy with antidepressant plus CBT. Summary answer and limitations Meta-analyses found no statistically significant difference in effectiveness between second generation antidepressants and CBT for response (risk ratio 0.91, 0.77 to 1.07), remission (0.98, 0.73 to 1.32), or change in 17 item Hamilton Rating Scale for Depression score (weighted mean difference, −0.38, −2.87 to 2.10). Similarly, no significant differences were found in rates of overall study discontinuation (risk ratio 0.90, 0.49 to 1.65) or discontinuation attributable to lack of efficacy (0.40, 0.05 to 2.91). Although more patients treated with a second generation antidepressant than receiving CBT withdrew from studies because of adverse events, the difference was not statistically significant (risk ratio 3.29, 0.42 to 25.72). No conclusions could be drawn about other outcomes because of lack of evidence. Results should be interpreted cautiously given the low strength of evidence for most outcomes. The scope of this review was limited to trials that enrolled adult patients with major depressive disorder and compared a second generation antidepressant with CBT, and many of the included trials had methodological shortcomings that may limit confidence in some of the findings. What this study adds Second generation antidepressants and CBT have evidence bases of benefits and harms in major depressive disorder. Available evidence suggests no difference in treatment effects of second generation antidepressants and CBT, either alone or in combination, although small numbers may preclude detection of small but clinically meaningful differences. Funding, competing interests, data sharing This project was funded under contract from the Agency for Healthcare Research and Quality by the RTI-UNC Evidence-based Practice Center. Detailed methods and additional information are available in the full report, available at http://effectivehealthcare.ahrq.gov/.

Practice-Based Interventions Addressing Concomitant Depression and Chronic Medical Conditions in the Primary Care Setting A Systematic Review and Meta-Analysis

Background: Depression concomitant with chronic medical conditions is common and burdensome in primary care. Objective: To assess the effectiveness of practice-based interventions for improving depression and chronic medical outcomes. Data Sources: MEDLINE, Embase, the Cochrane Library, CINAHL, and PsycINFO from inception to June 11, 2012. Study Selection, Appraisal, and Synthesis: Two reviewers independently selected, extracted data from, and rated the quality of trials and systematic reviews. Strength of evidence (SOE) was graded using established criteria. Results: Twenty-four published articles reported data from 12 studies, all at least 6 months long. All studies compared a form of collaborative care with usual or enhanced usual care. Studies evaluated adults with arthritis, cancer, diabetes, heart disease, HIV, or multiple medical conditions. Meta-analyses found that intervention recipients achieved greater improvement than controls in depression symptoms, response, remission, and depression-free days (moderate SOE); satisfaction with care (moderate SOE); and quality of life (moderate SOE). Few data were available on outcomes for chronic medical conditions. Meta-analyses revealed that patients with diabetes receiving collaborative care exhibited no difference in diabetes control compared with control groups (change in HbA1c: weighted mean difference 0.13, 95% confidence interval = −0.22 to 0.48 at 6 months; 0.24, 95% confidence interval = −0.14 to 0.62 at 12 months; low SOE). The only study to use HbA1c as a predefined outcome measure and a “treat-to-target” intervention for diabetes as well as depression, TEAMcare, reported significant reductions in HbA1c (7.42 vs 7.87 at 6 months; 7.33 vs 7.81 at 12 months; overall P < .001). Limitations: Few relevant trials reported on medical outcomes. Conclusions: Collaborative care interventions improved outcomes for depression and quality of life in primary care patients with varying medical conditions. Few data were available on medical outcomes. Future studies of concomitant depression and chronic medical conditions should consider measures of medical outcomes as primary outcomes.

Primary Care Screening and Treatment for Latent Tuberculosis Infection in Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force

IMPORTANCE Five to ten percent of individuals with latent tuberculosis infection (LTBI) progress to active tuberculosis (TB) disease. Identifying and treating LTBI is a key component of the strategy for reducing the burden of TB disease. OBJECTIVE To review the evidence about targeted screening and treatment for LTBI among adults in primary care settings to support the US Preventive Services Task Force in updating its 1996 recommendation. DATA SOURCES MEDLINE, Cochrane Library, and trial registries, searched through August 3, 2015; references from pertinent articles; and experts. Literature surveillance was conducted through May 31, 2016. STUDY SELECTION English-language studies of LTBI screening, LTBI treatment with recommended pharmacotherapy, or accuracy of the tuberculin skin test (TST) or interferon-gamma release assays (IGRAs). Studies of individuals for whom LTBI screening and treatment is part of public health surveillance or disease management were excluded. DATA EXTRACTION AND SYNTHESIS Two investigators independently reviewed abstracts and full-text articles. When at least 3 similar studies were available, random-effects meta-analysis was used to generate pooled estimates of outcomes. MAIN OUTCOMES AND MEASURES Sensitivity, specificity, reliability, active TB disease, mortality, hepatotoxicity, and other harms. RESULTS The review included 72 studies (n = 51 711). No studies evaluated benefits and harms of screening compared with no screening. Pooled estimates for sensitivity of the TST at both 5-mm and 10-mm induration thresholds were 0.79 (5-mm: 95% CI, 0.69-0.89 [8 studies, n = 803]; 10 mm: 95% CI, 0.71-0.87 [11 studies; n = 988]), and those for IGRAs ranged from 0.77 to 0.90 (57 studies; n = 4378). Pooled estimates for specificity of the TST at the 10-mm and 15-mm thresholds and for IGRAs ranged from 0.95 to 0.99 (34 studies; n = 23 853). A randomized clinical trial (RCT) of 24 weeks of isoniazid in individuals with pulmonary fibrotic lesions and LTBI (n = 27 830) found a reduction in absolute risk of active TB at 5 years from 1.4% to 0.5% (relative risk [RR], 0.35 [95% CI, 0.24-0.52]) and an increase in absolute risk for hepatoxicity from 0.1% to 0.5% (RR, 4.59 [95% CI, 2.03-10.39]) for 24 weeks of daily isoniazid compared with placebo. An RCT (n = 6886) found that 3 months of once-weekly rifapentine plus isoniazid was noninferior to 9 months of isoniazid alone for preventing active TB. The risk difference for hepatoxicity comparing isoniazid with rifampin ranged from 3% to 7%, with a pooled RR of 3.29 (95% CI, 1.72-6.28 [3 RCTs; n = 1327]). CONCLUSIONS AND RELEVANCE No studies evaluated the benefits and harms of screening compared with no screening. Both the TST and IGRAs are moderately sensitive and highly specific within countries with low TB burden. Treatment reduced the risk of active TB among the populations included in this review. Isoniazid is associated with higher rates of hepatotoxicity than placebo or rifampin.

Genetic polymorphisms and response to medications for alcohol use disorders: a systematic review and meta-analysis

AIM To assess whether response to medications for alcohol use disorders varies by genotype. METHODS Systematic review and meta-analysis. RESULTS We found no studies that assessed the clinical utility of genotype-guided dosing strategies or genotype-guided medication selection, and none randomized by genotype. All included studies assessed the association between genotype and response to medication. Of 15 included studies, eight (n = 1365 participants) assessed variation in naltrexone response and polymorphisms of OPRM1. Our meta-analyses for return to heavy drinking found no significant difference between A allele homozygotes and those with at least one G allele, both without (risk difference: 0.26; 95% CI: -0.01-0.53; n = 174) and with inclusion of studies rated as high or unclear risk of bias (risk difference: 0.14; 95% CI: -0.03-0.3; n = 382). For all other polymorphism-medication pairs, we found just one eligible study. CONCLUSION Estimates of effect for return to heavy drinking suggest it is possible that patients with at least one G allele of A118G polymorphism of OPRM1 might be more likely to respond to naltrexone, but confidence intervals were wide; additional studies are needed to improve confidence in the estimates.