Zackary Berger

Meditation Programs for Psychological Stress and Well-being: A Systematic Review and Meta-analysis

IMPORTANCEnMany people meditate to reduce psychological stress and stress-related health problems. To counsel people appropriately, clinicians need to know what the evidence says about the health benefits of meditation.nnnOBJECTIVEnTo determine the efficacy of meditation programs in improving stress-related outcomes (anxiety, depression, stress/distress, positive mood, mental health-related quality of life, attention, substance use, eating habits, sleep, pain, and weight) in diverse adult clinical populations.nnnEVIDENCE REVIEWnWe identified randomized clinical trials with active controls for placebo effects through November 2012 from MEDLINE, PsycINFO, EMBASE, PsycArticles, Scopus, CINAHL, AMED, the Cochrane Library, and hand searches. Two independent reviewers screened citations and extracted data. We graded the strength of evidence using 4 domains (risk of bias, precision, directness, and consistency) and determined the magnitude and direction of effect by calculating the relative difference between groups in change from baseline. When possible, we conducted meta-analyses using standardized mean differences to obtain aggregate estimates of effect size with 95% confidence intervals.nnnFINDINGSnAfter reviewing 18 753 citations, we included 47 trials with 3515 participants. Mindfulness meditation programs had moderate evidence of improved anxiety (effect size, 0.38 [95% CI, 0.12-0.64] at 8 weeks and 0.22 [0.02-0.43] at 3-6 months), depression (0.30 [0.00-0.59] at 8 weeks and 0.23 [0.05-0.42] at 3-6 months), and pain (0.33 [0.03- 0.62]) and low evidence of improved stress/distress and mental health-related quality of life. We found low evidence of no effect or insufficient evidence of any effect of meditation programs on positive mood, attention, substance use, eating habits, sleep, and weight. We found no evidence that meditation programs were better than any active treatment (ie, drugs, exercise, and other behavioral therapies).nnnCONCLUSIONS AND RELEVANCEnClinicians should be aware that meditation programs can result in small to moderate reductions of multiple negative dimensions of psychological stress. Thus, clinicians should be prepared to talk with their patients about the role that a meditation program could have in addressing psychological stress. Stronger study designs are needed to determine the effects of meditation programs in improving the positive dimensions of mental health and stress-related behavior.

Comparative Effectiveness and Safety of Methods of Insulin Delivery and Glucose Monitoring for Diabetes Mellitus: A Systematic Review and Meta-analysis

BACKGROUNDnPatients with diabetes mellitus need information about the effectiveness of innovations in insulin delivery and glucose monitoring.nnnPURPOSEnTo review how intensive insulin therapy (multiple daily injections [MDI] vs. rapid-acting analogue-based continuous subcutaneous insulin infusion [CSII]) or method of monitoring (self-monitoring of blood glucose [SMBG] vs. real-time continuous glucose monitoring [rt-CGM]) affects outcomes in types 1 and 2 diabetes mellitus.nnnDATA SOURCESnMEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through February 2012 without language restrictions.nnnSTUDY SELECTIONn33 randomized, controlled trials in children or adults that compared CSII with MDI (n=19), rt-CGM with SMBG (n=10), or sensor-augmented insulin pump use with MDI and SMBG (n=4).nnnDATA EXTRACTIONn2 reviewers independently evaluated studies for eligibility and quality and serially abstracted data.nnnDATA SYNTHESISnIn randomized, controlled trials, MDI and CSII showed similar effects on hemoglobin A1c (HbA1c) levels and severe hypoglycemia in children or adults with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. In adults with type 1 diabetes mellitus, HbA1c levels decreased more with CSII than with MDI, but 1 study heavily influenced these results. Compared with SMBG, rt-CGM achieved a lower HbA1c level (between-group difference of change, 0.26% [95% CI, 0.33% to 0.19%]) without any difference in severe hypoglycemia. Sensor-augmented insulin pump use decreased HbA1c levels more than MDI and SMBG did in persons with type 1 diabetes mellitus (between-group difference of change, 0.68% [CI, 0.81% to 0.54%]). Little evidence was available on other outcomes.nnnLIMITATIONnMany studies were small, of short duration, and limited to white persons with type 1 diabetes mellitus.nnnCONCLUSIONnContinuous subcutaneous insulin infusion and MDI have similar effects on glycemic control and hypoglycemia, except CSII has a favorable effect on glycemic control in adults with type 1 diabetes mellitus. For glycemic control, rt-CGM is superior to SMBG and sensor-augmented insulin pumps are superior to MDI and SMBG without increasing the risk for hypoglycemia.nnnPRIMARY FUNDING SOURCEnAgency for Healthcare Research and Quality.

The "top 5" lists in primary care: Meeting the responsibility of professionalism

BACKGROUNDnPhysicians can adhere to the principles of professionalism by practicing high-quality, evidence-based care and advocating for just and cost-effective distribution of finite clinical resources. To promote these principles, the National Physicians Alliance (NPA) initiated a project titled Promoting Good Stewardship in Clinical Practice that aimed to develop a list of the top 5 activities in family medicine, internal medicine, and pediatrics where the quality of care could be improved.nnnMETHODSnWorking groups of NPA members in each of the 3 primary care specialties agreed that an ideal activity would be one that was common in primary care practice, that was strongly supported by the evidence, and that would lead to significant health benefits and reduce risks, harms, and costs. A modification of nominal group process was used to generate a preliminary list of activities. A first round of field testing was conducted with 83 primary care physicians, and a second round of field testing with an additional 172 physicians.nnnRESULTSnThe first round of field testing resulted in 1 activity being deleted from the family medicine list. Support for the remaining activities was strong. The second round of field testing showed strong support for all activities. The family medicine and internal medicine groups independently selected 3 activities that were the same, so the final lists reflect 12 unique activities that could improve clinical care.nnnCONCLUSIONSnPhysician panels in the primary care specialties of family medicine, internal medicine, and pediatrics identified common clinical activities that could lead to higher quality care and better use of finite clinical resources. Field testing showed support among physicians for the evidence supporting the activities, the potential positive impact on medical care quality and cost, and the ease with which the activities could be performed. We recommend that these Top 5 lists of activities be implemented in primary care practice across the United States.

Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes: A Systematic Review and Meta-analysis

Type 2 diabetes and its complications are a substantial public health burden, affecting 9.3% of the U.S. adult population (1, 2). Most patients with type 2 diabetes eventually require glucose-lowering pharmacologic therapy, with a goal of reducing long-term complications. More than 7 classes of diabetes medications, which differ in their effects on glucose-lowering, safety, and other important outcomes, are recommended as first- or second-line therapy (3, 4). The Agency for Healthcare Research and Quality (AHRQ) published 2 detailed reports comparing monotherapies and medication combinations for adults with type 2 diabetes (5, 6), but many new medications have been approved by the U.S. Food and Drug Administration (FDA) since then. These include medications in a new class, the sodiumglucose cotransporter 2 (SGLT-2) inhibitors, and several new dipeptidyl peptidase-4 (DPP-4) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists. Evidence on the newer versus older diabetes medications continues to amass, and we performed an updated systematic review of the comparative effectiveness and safety of medications for type 2 diabetes in terms of intermediate, long-term, and safety outcomes. This review focused on monotherapy comparisons and combination comparisons that include metformin, with the aim of providing the range of stakeholders, including patients and clinicians, a synthesis of the current evidence on the most common monotherapies and combination therapies used to treat type 2 diabetes. Methods With input from a technical expert panel and representatives from AHRQ, we developed a protocol (available at www.effectivehealthcare.ahrq.gov). The full evidence report (7) has additional details on the methods and results, including search strategies and evidence tables. Data Sources and Searches We searched MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. The search strategy included terms for the diabetes medications of interest and terms for type 2 diabetes (Appendix Table 1 provides the MEDLINE search strategy). Appendix Table 1. MEDLINE Search String We ran the search developed for the prior review with the date restrictions of April 2009 through March 2015. We ran an additional search that included the Medical Subject Heading terms and text words for all of the new medications included in this update, without any date restrictions. After completion of the evidence report (7), we searched MEDLINE through December 2015, and updated our findings where the strength of evidence changed from low or insufficient to moderate or high. We hand-searched the reference lists of all newly included articles and relevant systematic reviews. In addition, we searched ClinicalTrials.gov to identify relevant registered trials and reviewed the FDA Web site for any unpublished additional studies relevant to the topic as part of our gray-literature search. Study Selection Two reviewers independently screened titles, abstracts, and full-text articles for inclusion and resolved differences through consensus. We included English-language studies of nonpregnant adults with type 2 diabetes that evaluated at least 3 months of use of a diabetes medication or drug combination of interest. We included head-to-head monotherapy comparisons of metformin, thiazolidinediones, sulfonylureas, DPP-4 inhibitors, SGLT-2 inhibitors, and GLP-1 receptor agonists; comparisons of metformin alone with a metformin-based combination; and comparisons of metformin-based combinations where the second medication was one of the monotherapies described above or a basal or premixed insulin (Appendix Table 2). We excluded studies that did not specify adjunctive medications. We excluded acarbose because of its infrequent use and the absence of new key studies that would substantially change the conclusions from our original report (5, 8). Appendix Table 2. Priority Medication Comparisons Included for Each Key Question We included randomized, controlled trials (RCTs) that evaluated all-cause mortality, macrovascular outcomes, microvascular outcomes, intermediate outcomes, or safety (7). We also included observational studies that adequately accounted for confounding, although not for the intermediate outcomes. Data Extraction, Quality, and Applicability Assessment Using standardized forms, reviewers extracted information on the general study and participant characteristics, interventions, comparisons, and the outcome results. A second reviewer confirmed the abstracted data. Two independent reviewers assessed risk of bias in individual RCTs by using the criteria of Jadad and colleagues (9), as in our prior review (6). We used the Downs and Black tool for assessment of the risk of bias for the nonrandomized trials and observational studies (10). To assess study applicability, we evaluated whether the study population, interventions, outcomes, and settings were similar to usual care for people with type 2 diabetes in the United States. Data Synthesis and Analysis We created a set of detailed evidence tables. We conducted meta-analyses when data were sufficient (from at least 3 trials) and studies were sufficiently homogenous with respect to key variables (population characteristics, study duration, and medication dosing). When a trial had more than 1 study group, we included in the quantitative pooling the study group with drug doses and study durations most similar to the other studies for that comparison and outcome. We pooled the mean difference between groups for continuous outcomes and calculated pooled odds ratios for the dichotomous outcomes using the intention-to-treat denominator. We evaluated the heterogeneity among the trials by using the I 2 statistic (11). We generated summary treatment effects with the random-effects model estimated by using the DerSimonian and Laird method in settings of low heterogeneity (I 2< 50%) (12) and the profile likelihood estimate in settings of high heterogeneity (I 2 50%) (13). Grading of the Evidence Adapting an evidence grading scheme recommended in the AHRQ guide for conducting comparative effectiveness reviews (14), 2 reviewers sequentially graded the studies limitations, consistency, directness, precision, and potential reporting bias for the evidence on each outcome and comparison. We graded the evidence separately for RCTs and observational studies. The final evidence grade and conclusion were based on the RCTs and could be strengthened by evidence from observational studies with few study limitations. High strength of evidence indicates that the evidence probably reflects the true effect; moderate strength indicates that further research may change the result; and low strength indicates low confidence that the evidence reflects the true effect, and further research is very likely to change the result. Insufficient evidence indicates that evidence is unavailable or the body of evidence has unacceptable deficiencies, precluding a conclusion. Role of the Funding Source The AHRQ reviewed the protocol and report but did not participate in the literature search, determination of study eligibility, analysis, interpretation of findings, or preparation, review, or approval of the manuscript for publication. Results Study and Quality Characteristics We included 204 studies, 116 of which are newly identified, in this updated review (Appendix Figure). Eighty-one percent were RCTs. Appendix Table 3 shows the number and design of studies, by outcome. Fifty studies were multicontinental; the others were conducted in Europe (55 studies), Asia (39 studies), and the United States (34 studies). Study durations ranged from 3 months to 8 years, but only 22 studies (7 RCTs) lasted longer than 2 years. Only 1 RCT specified a cardiovascular outcome as a primary outcome (15). Appendix Table 3. Number of Studies for Each Type of Outcome* Appendix Figure. Summary of evidence search and selection. FDA = U.S. Food and Drug Administration; RCT = randomized, controlled trial. * Total may exceed the number in the corresponding box because articles could be excluded for >1 reason at this level. Comorbid condition restrictions were end-stage renal disease, end-stage liver disease, cancer, new-onset diabetes after transplant, or a cardiovascular event within 3 mo (such as acute coronary syndrome, acute myocardial infarction, postcoronary artery bypass graft surgery, or drug-eluting stents). Study participants were overweight or obese men and women with baseline hemoglobin A1c levels between 7% and 9%. About 45% of the RCTs did not report race/ethnicity. When reported, only 10% to 30% of the enrolled population was of nonwhite race. Most studies excluded older persons and those with clinically significant comorbid conditions. Of the randomized trials, approximately one half reported on their randomization scheme. Sixty-five percent reported double-blinding, but most did not report steps taken to ensure double-blinding. Of the newly included RCTs, losses to follow-up exceeded 20% in the majority (>70%) of trials lasting 1 year or more and in 24% of those lasting less than 1 year. Most studies used the last-observation-carried-forward approach for analysis of intermediate outcomes. Of the newly included trials, use of rescue therapy was reported in 35%, but 42% did not report on this. All included observational studies were at low risk of bias. Sixty-seven percent of studies reported receiving funding from pharmaceutical companies. We did not identify substantive reporting bias that would have affected our findings. All-Cause Mortality and Macrovascular and Microvascular Outcomes Although we included 65 new studies (52 RCTs and 13 observational studies) for these outcomes in this review, the trials were largely 1 year or less in duration, with few or no events; the evidence was insufficient or of low strength for almost all comparisons for these outcomes. However, we found moderate strength of evidence that metformin monoth

Application of “Less Is More” to Low Back Pain

An initiative of the National Physicians Alliance, the project titled Promoting Good Stewardship in Clinical Practice, developed a list of the top 5 activities in primary care for which changes in practice could lead to higher-quality care and better use of finite clinical resources. One of the top 5 recommendations was Dont do imaging for low back pain within the first 6 weeks unless red flags are present. This article presents data that support this recommendation. We selectively reviewed the literature, including recent reviews, guidelines, and commentaries, on the benefits and risks of routine imaging in low back pain. In particular, we searched PubMed for systematic reviews or meta-analyses published in the past 5 years. We also assessed the cost of spine imaging using data from the National Ambulatory Medical Care Survey. One high-quality systematic review and meta-analysis focused on clinical outcomes in patients with low back pain and found no clinically significant difference in pain or function between those who received immediate lumbar spine imaging vs usual care. Published data also document harms associated with early imaging for low back pain, including patient labeling, unneeded follow-up tests for incidental findings, irradiation exposure, unnecessary surgery, and significant cost. Routine imaging should not be pursued in acute low back pain. Not imaging patients with acute low back pain will reduce harms and costs, without affecting clinical outcomes.

Promoting engagement by patients and families to reduce adverse events in acute care settings: a systematic review

Introduction Patient-centeredness is central to healthcare. Hospitals should address patients’ unique needs to improve safety and quality. Patient engagement in healthcare, which may help prevent adverse events, can be approached as an independent patient safety practice (PSP) or as part of a multifactorial PSP. Objectives This review examines how interventions encouraging this engagement have been implemented in controlled trials. Methods We searched Medline, CINAHL, Embase and Cochrane from 2000 to 2012 for English language studies in hospital settings with prospective controlled designs, addressing the effectiveness or implementation of patient/family engagement in PSPs. We separately reviewed interventions implemented as part of selected broader PSPs by way of example: hand hygiene, ventilator-associated pneumonia, rapid response systems and care transitions. Results Six articles met the inclusion criteria for effectiveness with a primary focus on patient engagement. We identified 12 studies implementing patient engagement as an aspect of selected broader PSPs. A number of studies relied on patients’ possible function as a reporter of error to healthcare workers and patients as a source of reminders regarding safety behaviours, while others relied on direct activation of patients or families. Definitions of patient and family engagement were lacking, as well as evidence regarding the types of patients who might feel comfortable engaging with providers, and in what contexts. Conclusions While patient engagement in safety is appealing, there is insufficient high-quality evidence informing real-world implementation. Further work should evaluate the effectiveness of interventions on patient and family engagement and clarify the added benefit of incorporating engagement in multifaceted approaches to improve patient safety endpoints. In addition, strategies to assess and overcome barriers to patients’ willingness to actively engage in their care should be investigated.

What are health-related users tweeting? A qualitative content analysis of health-related users and their messages on Twitter

Background Twitter is home to many health professionals who send messages about a variety of health-related topics. Amid concerns about physicians posting inappropriate content online, more in-depth knowledge about these messages is needed to understand health professionals’ behavior on Twitter. Objective Our goal was to characterize the content of Twitter messages, specifically focusing on health professionals and their tweets relating to health. Methods We performed an in-depth content analysis of 700 tweets. Qualitative content analysis was conducted on tweets by health users on Twitter. The primary objective was to describe the general type of content (ie, health-related versus non-health related) on Twitter authored by health professionals and further to describe health-related tweets on the basis of the type of statement made. Specific attention was given to whether a tweet was personal (as opposed to professional) or made a claim that users would expect to be supported by some level of medical evidence (ie, a “testable” claim). A secondary objective was to compare content types among different users, including patients, physicians, nurses, health care organizations, and others. Results Health-related users are posting a wide range of content on Twitter. Among health-related tweets, 53.2% (184/346) contained a testable claim. Of health-related tweets by providers, 17.6% (61/346) were personal in nature; 61% (59/96) made testable statements. While organizations and businesses use Twitter to promote their services and products, patient advocates are using this tool to share their personal experiences with health. Conclusions Twitter users in health-related fields tweet about both testable claims and personal experiences. Future work should assess the relationship between testable tweets and the actual level of evidence supporting them, including how Twitter users—especially patients—interpret the content of tweets posted by health providers.

Shared Decision Making and Choice for Elective Surgical Care: A Systematic Review.

Objective Shared decision making (SDM), an integrative patient-provider communication process emphasizing discussion of scientific evidence and patient/family values, may improve quality care delivery, promote evidence-based practice, and reduce overuse of surgical care. Little is known, however, regarding SDM in elective surgical practice. The purpose of this systematic review is to synthesize findings of studies evaluating use and outcomes of SDM in elective surgery. Data Sources PubMed, Cochrane CENTRAL, EMBASE, CINAHL, and SCOPUS electronic databases. Review Methods We searched for English-language studies (January 1, 1990, to August 9, 2015) evaluating use of SDM in elective surgical care where choice for surgery could be ascertained. Identified studies were independently screened by 2 reviewers in stages of title/abstract and full-text review. We abstracted data related to population, study design, clinical dilemma, use of SDM, outcomes, treatment choice, and bias. Results Of 10,929 identified articles, 24 met inclusion criteria. The most common area studied was spine (7 of 24), followed by joint (5 of 24) and gynecologic surgery (4 of 24). Twenty studies used decision aids or support tools, including modalities that were multimedia/video (13 of 20), written (3 of 20), or personal coaching (4 of 20). Effect of SDM on preference for surgery was mixed across studies, showing a decrease in surgery (9 of 24), no difference (8 of 24), or an increase (1 of 24). SDM tended to improve decision quality (3 of 3) as well as knowledge or preparation (4 of 6) while decreasing decision conflict (4 of 6). Conclusion SDM reduces decision conflict and improves decision quality for patients making choices about elective surgery. While net findings show that SDM may influence patients to choose surgery less often, the impact of SDM on surgical utilization cannot be clearly ascertained.

A three-talk model for shared decision making: multistage consultation process

Objectives To revise an existing three-talk model for learning how to achieve shared decision making, and to consult with relevant stakeholders to update and obtain wider engagement. Design Multistage consultation process. Setting Key informant group, communities of interest, and survey of clinical specialties. Participants 19 key informants, 153 member responses from multiple communities of interest, and 316 responses to an online survey from medically qualified clinicians from six specialties. Results After extended consultation over three iterations, we revised the three-talk model by making changes to one talk category, adding the need to elicit patient goals, providing a clear set of tasks for each talk category, and adding suggested scripts to illustrate each step. A new three-talk model of shared decision making is proposed, based on “team talk,” “option talk,” and “decision talk,” to depict a process of collaboration and deliberation. Team talk places emphasis on the need to provide support to patients when they are made aware of choices, and to elicit their goals as a means of guiding decision making processes. Option talk refers to the task of comparing alternatives, using risk communication principles. Decision talk refers to the task of arriving at decisions that reflect the informed preferences of patients, guided by the experience and expertise of health professionals. Conclusions The revised three-talk model of shared decision making depicts conversational steps, initiated by providing support when introducing options, followed by strategies to compare and discuss trade-offs, before deliberation based on informed preferences.

Characteristics and Experiences of Patients with Localized Prostate Cancer Who Left an Active Surveillance Program

BackgroundUnderstanding the experiences of men leaving active surveillance programs is critical to making such programs viable for men with localized prostate cancer.ObjectiveTo generate hypotheses about the factors that influence patients’ decisions to leave an active surveillance program.MethodsUsing data from the Johns Hopkins active surveillance cohort, bivariate analyses and multinomial regression models examined characteristics of men who self-elected to leave, those who stayed in the program, and those who left because of disease reclassification. We interviewed patients who self-elected to leave.ResultsOf 1,159 men in active surveillance, 9xa0% self-elected to leave. In interviews with a sample of 14 men who self-elected to leave, uncertainty involved in active surveillance participation, existence of personal criteria—distinct from providers’ clinical criteria—and fear of cancer were important factors in decisions to leave.ConclusionMen leaving active surveillance were motivated by a number of factors, including patient-defined criteria, which might differ from clinical recommendations. To ensure active surveillance participation, it may be important to address cancer-related anxiety and personal criteria underlying patient decisions.