Cancer constitutes an enormous burden on society in more and less economically developed countries alike. The occurrence of cancer is increasing because of the growth and aging of the population, as well as an increasing prevalence of established risk factors such as smoking, overweight, physical inactivity, and changing reproductive patterns associated with urbanization and economic development. Based on GLOBOCAN estimates, about 14.1 million new cancer cases and 8.2 million deaths occurred in 2012 worldwide. Over the years, the burden has shifted to less developed countries, which currently account for about 57% of cases and 65% of cancer deaths worldwide. Lung cancer is the leading cause of cancer death among males in both more and less developed countries, and has surpassed breast cancer as the leading cause of cancer death among females in more developed countries; breast cancer remains the leading cause of cancer death among females in less developed countries. Other leading causes of cancer death in more developed countries include colorectal cancer among males and females and prostate cancer among males. In less developed countries, liver and stomach cancer among males and cervical cancer among females are also leading causes of cancer death. Although incidence rates for all cancers combined are nearly twice as high in more developed than in less developed countries in both males and females, mortality rates are only 8% to 15% higher in more developed countries. This disparity reflects regional differences in the mix of cancers, which is affected by risk factors and detection practices, and/or the availability of treatment. Risk factors associated with the leading causes of cancer death include tobacco use (lung, colorectal, stomach, and liver cancer), overweight/obesity and physical inactivity (breast and colorectal cancer), and infection (liver, stomach, and cervical cancer). A substantial portion of cancer cases and deaths could be prevented by broadly applying effective prevention measures, such as tobacco control, vaccination, and the use of early detection tests.

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Global cancer statistics, 2012

Chronic obstructive pulmonary disease (COPD) remains a major public health problem. It is the fourth leading cause of chronic morbidity and mortality in the United States, and is projected to rank fifth in 2020 in burden of disease worldwide, according to a study published by the World Bank/World Health Organization. Yet, COPD remains relatively unknown or ignored by the public as well as public health and government officials. In 1998, in an effort to bring more attention to COPD, its management, and its prevention, a committed group of scientists encouraged the U.S. National Heart, Lung, and Blood Institute and the World Health Organization to form the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Among the important objectives of GOLD are to increase awareness of COPD and to help the millions of people who suffer from this disease and die prematurely of it or its complications. The first step in the GOLD program was to prepare a consensus report, Global Strategy for the Diagnosis, Management, and Prevention of COPD, published in 2001. The present, newly revised document follows the same format as the original consensus report, but has been updated to reflect the many publications on COPD that have appeared. GOLD national leaders, a network of international experts, have initiated investigations of the causes and prevalence of COPD in their countries, and developed innovative approaches for the dissemination and implementation of COPD management guidelines. We appreciate the enormous amount of work the GOLD national leaders have done on behalf of their patients with COPD. Despite the achievements in the 5 years since the GOLD report was originally published, considerable additional work is ahead of us if we are to control this major public health problem. The GOLD initiative will continue to bring COPD to the attention of governments, public health officials, health care workers, and the general public, but a concerted effort by all involved in health care will be necessary.

https://www.who.int/respiratory/copd/GOLD_WR_06.pdf

Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary.

https://caltcm.memberclicks.net/assets/documents/acc_aha_chf_2013_guidelines.pdf

2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines

XI. STRATEGIES FOR IMPROVING DIABETES CARE D iabetes is a chronic illness that requires continuing medical care and patient self-management education to prevent acute complications and to reduce the risk of long-term complications. Diabetes care is complex and requires that many issues, beyond glycemic control, be addressed. A large body of evidence exists that supports a range of interventions to improve diabetes outcomes. These standards of care are intended to provide clinicians, patients, researchers, payors, and other interested individuals with the components of diabetes care, treatment goals, and tools to evaluate the quality of care. While individual preferences, comorbidities, and other patient factors may require modification of goals, targets that are desirable for most patients with diabetes are provided. These standards are not intended to preclude more extensive evaluation and management of the patient by other specialists as needed. For more detailed information, refer to Bode (Ed.): Medical Management of Type 1 Diabetes (1), Burant (Ed): Medical Management of Type 2 Diabetes (2), and Klingensmith (Ed): Intensive Diabetes Management (3). The recommendations included are diagnostic and therapeutic actions that are known or believed to favorably affect health outcomes of patients with diabetes. A grading system (Table 1), developed by the American Diabetes Association (ADA) and modeled after existing methods, was utilized to clarify and codify the evidence that forms the basis for the recommendations. The level of evidence that supports each recommendation is listed after each recommendation using the letters A, B, C, or E.

Standards of Medical Care in Diabetes

Background In patients with high cholesterol levels, lowering the cholesterol level reduces the risk of coronary events, but the effect of lowering cholesterol levels in the majority of patients with coronary disease, who have average levels, is less clear. Methods In a double-blind trial lasting five years, we administered either 40 mg of pravastatin per day or placebo to 4159 patients (3583 men and 576 women) with myocardial infarction who had plasma total cholesterol levels below 240 mg per deciliter (mean, 209) and low-density lipoprotein (LDL) cholesterol levels of 115 to 174 mg per deciliter (mean, 139). The primary end point was a fatal coronary event or a nonfatal myocardial infarction. Results The frequency of the primary end point was 10.2 percent in the pravastatin group and 13.2 percent in the placebo group, an absolute difference of 3 percentage points and a 24 percent reduction in risk (95 percent confidence interval, 9 to 36 percent; P = 0.003). Coronary bypass surgery was needed in 7.5 per...

The Effect of Pravastatin on Coronary Events after Myocardial Infarction in Patients with Average Cholesterol Levels

A number of new biological markers are being studied as predictors of disease or adverse medical events among those who already have a disease. Systematic reviews of this growing literature can help determine whether the available evidence supports use of a new biomarker as a prognostic test that can more accurately place patients into different prognostic groups to improve treatment decisions and the accuracy of outcome predictions. Exemplary reviews of prognostic tests are not widely available, and the methods used to review diagnostic tests do not necessarily address the most important questions about prognostic tests that are used to predict the time-dependent likelihood of future patient outcomes. We provide suggestions for those interested in conducting systematic reviews of a prognostic test. The proposed use of a prognostic test should serve as the framework for a systematic review and help define the key questions. The outcome probabilities or level of risk and other characteristics of prognostic groups are the most salient statistics for review and perhaps meta-analysis. Reclassification tables can help determine how a prognostic test affects the classification of patients into different prognostic groups, and hence helps determine their treatment. However, review of studies of the association between a potential prognostic test and patient outcomes would have little impact other than to determine whether further development as a prognostic test might be warranted.

Systematic Review of Prognostic Tests

Introduction: Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that health care recommendations are informed by the best available research evidence. This is the fifth of a series of 14 articles that were prepared by an international panel to advise guideline developers in respiratory and other diseases on approaches for guideline development. This article focuses on what type of evidence and outcomes to include in guidelines.Methods: In this review we addressed the following topics and questions. (1) What methods should be used to select important outcomes? (2) What types of outcomes should be considered? (3) What sources of evidence should be considered? (4) How should the importance of outcomes be ranked? (5) How to deal with surrogate outcomes. (6) What issues related to outcomes should be considered in the evidence review? (7) What quality of evidence should be used? (8) How to interpret the effect on outcomes. (...

https://www.atsjournals.org/doi/pdf/10.1513/pats.201208-058ST

Deciding what type of evidence and outcomes to include in guidelines: article 5 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

https://www.amjmed.com/article/S0002-9343(98)00127-2/pdf

Prostate Cancer Screening: Practice What the Evidence Preaches

/pdf/expanded-access-to-lung-cancer-screening-implementing-wisely-2f6n1zxmku.pdf

Expanded Access to Lung Cancer Screening—Implementing Wisely to Optimize Health

s Triaged: 6,334 Abstracts Excluded: 5,775s Excluded: 5,775 Full Text Review: 559 Articles Excluded: 539 Articles Not an included study design: 260 No intervention: 108 Outpatient setting: 71 Not stewardship: 57 Other: 43 Hand Search: 15 Articles Included: 35 Studies Evidence-based Synthesis Program (ESP) Results • Existing Cochrane Review (Davey 2013) • Included 89 studies published through 2009 • Focused on prescribing outcomes • Categorized interventions as: • Persuasive (education, reminders, audit and feedback) • Restrictive (order forms, formulary restriction) • Structural (EMR, decision support systems) Evidence-based Synthesis Program (ESP) Results (Davey 2013) • Patient-Centered Outcomes Mortality • Interventions to increase guideline compliance for patients with community acquired pneumonia reduced mortality: • (4 studies, RR 0.89 [0.82, 0.97]) • Interventions to increase effective prescribing (3 studies) and interventions to decrease excessive prescribing (11 studies) were not significantly associated with mortality Evidence-based Synthesis Program (ESP) Results (Davey 2013) • Patient-Centered Outcomes Other • Interventions to decrease excessive prescribing : • No effect length of stay • (6 studies, mean difference, -0.04 days [-0.34, 0.25]) • Associated with increased hospital readmissions • (5 studies, 1.26 [1.02, 1.57]) • Reduction in C. difficile infection: • 15% to 65% at one month post-intervention • 4 interrupted time series studies Evidence-based Synthesis Program (ESP) Results (Davey 2013) • Prescribing Outcomes • Calculated median effect size with all prescribing outcomes; positive sign = change in intended direction • Persuasive, restrictive, and structural interventions: • Associated with improved prescribing • Median change in prescribing ranged from 4% to 46% across intervention types and study design types Evidence-based Synthesis Program (ESP) Results • VA-ESP Evidence o 9 RCTs, 4 CCTs, 2 CBAs, 20 ITS studies o Categorized studies by intervention type: • 14 audit and feedback • 5 formulary restriction and preauthorization • 4 guideline implementation with feedback • 4 guideline implementation with no feedback • 4 computerized decision support • 4 protocol or policy implementation Evidence-based Synthesis Program (ESP) ASP Intervention (# studies) Mortality Length of Stay Readmission CDI Prospective Audit and Feedback (14) + 1 study ≈ 9 studies ≈ 9 studies + 1 study ≈ 2 studies p=NR, 1 study Formulary Restriction and Preauthorization (5) ≈ 3 studies ≈ 2 studies NR + 1 study Guidelines with Feedback (4) ≈ 3 studies ≈ 3 studies NR + 2 studies Guidelines without Feedback (4) + 1 study ≈ 1study 1 study + 1 study ≈ 1study 1 study ≈ 1 study NR Computerized Decision Support (4) ≈ 3 studies + 1 study ≈ 2 studies ≈ 1 study + 1 study ≈ 1 study Protocols (4) + 1 study ≈ 2 studies + 2 studies ≈ 1 study ≈ 1 study NR KQ1 – Program Effectiveness: Clinical Outcomes Evidence-based Synthesis Program (ESP) KQ1 – Program Effectiveness: Prescribing Outcomes ASP Intervention (# studies) Use Selection Timing Duration Prospective Audit and Feedback (14) Decreased: + 8 studies Appropriate: + 1 study, ≈ 1 study + 1 study ≈ 1 study NR + 5 studies Formulary Restriction and Preauthorization (5) Decreased: + 4 studies NR NR + 1 study Guidelines with Feedback (4) Decreased: + 1 study Compliant/appropriate: + 2 studies ≈ 1 study + 1 study ≈ 2 studies Guidelines without Feedback (4) Decreased: + 1 study Compliant/ appropriate: + 2 studies, ≈ 1 study NR 1 study + 1 study ≈ 1 study Computerized Decision Support (4) Decreased: + 1 study, ≈ 1 study NR NR NR Protocols (4) Appropriate: ≈ 1 study NR ≈ 1 study + 2 studies Evidence-based Synthesis Program (ESP) KQ1 Program Effectiveness • Microbial Outcomes (9 studies) o 6 reported improvement  decreased infection or resistance o 3 reported no differences • Cost Outcomes (5 studies) o 4 reported decreased costs o 1 reported no difference Evidence-based Synthesis Program (ESP) KQ2 Results – Key Implementation Components • All author opinion (6 studies) o Consistent and persistent effort from qualified personnel o Effective communication skills o Support from electronic medical records or computerized decision support systems Evidence-based Synthesis Program (ESP) KQ3 Results – Effectiveness in Different Settings or Different Suspected Conditions • Davey 2013 review o 9 from VA Medical Centers o Similar results (unchanged mortality [1], decreased CDI [2], mixed results prescribing [3], decreased infection [3]) • No recent studies from VA eligible • Most studies from University-affiliated hospitals Evidence-based Synthesis Program (ESP) KQ3 Results – Effectiveness in Different Settings or Different Suspected Conditions • ICU programs (9 studies) o Similar to overall results • Most studies included “any suspected infection” • Respiratory infection (7 studies) o Similar to overall results Evidence-based Synthesis Program (ESP) KQ4 Results – Harms of Programs • 2 studies reported possible harms (other than patient, prescribing, and microbial harms from KQ1) o Anecdotal evidence of inappropriate switch to narrow-spectrum antimicrobial o Termination of program speculated to be due to provider dissatisfaction with prescribing restrictions Evidence-based Synthesis Program (ESP) KQ5 Results – Barriers to Implementation, Sustainability, Scalability • Barriers (4 studies; 2 with interview/survey data) o Lack of familiarity, experience, awareness o Disagreement with guidelines/conflicting guidelines o Lack of communication between professionals o Organizational constraints • Sustainability (1 study) o Use and costs decreased over 5 years of study and increased when study was terminated • Scalability (No studies) Evidence-based Synthesis Program (ESP) Discussion • Antimicrobial stewardship strategies can decrease antimicrobial prescribing and limit costs, without substantial harms • Greatest body of recent evidence is from audit and feedback programs • Systematic review of earlier studies provided evidence of comparable effects for persuasive and restrictive interventions • Evidence base for KQ1 was substantial; much less substantial for KQ2-5 Evidence-based Synthesis Program (ESP) Discussion • Studies not designed to adequately assess impact on mortality or other clinical outcomes • Suggestions for improving adherence to ASPs: o Involvement of stakeholders and opinion leaders in guideline and program development o Addition of quality improvement cycles o Understanding the prescribing culture o Collaboration between physicians and pharmacists (mostly opinion rather than evidence-based) Evidence-based Synthesis Program (ESP) Discussion • Limitations: • Quality of evidence: Low • Few randomized controlled trials • Limited ability to control for secular trends or other confounding variables • Possibility of regression to the mean in C. difficile rates • Findings for specific interventions have not been replicated Evidence-based Synthesis Program (ESP) Discussion • Limitations (continued): • Prescribing improvements often not sustained or long-term follow-up not reported • Most studies done in academic medical centers; generalizability to other settings is difficult. Evidence-based Synthesis Program (ESP) Discussion • Limitations (continued): • Within academic centers, substantial variation in settings, structures, patient bases, culture o Strength: stewardship has impact in diverse settings o Weakness: Hard to be sure that each specific intervention works across all settings • Few studies reported on harms of stewardship interventions; most not designed to identify harms, and most would not have been adequately powered to recognize them Evidence-based Synthesis Program (ESP) Future Research Needs • Given the complexity of antimicrobial prescribing, conducting well-designed studies is difficult • Large healthcare organizations should consider organizing stewardship activities (that are likely on-going within the organization) to provide useful information on comparative effectiveness of different intervention types Evidence-based Synthesis Program (ESP) Overall Conclusions • Despite these many shortcomings, the overall evidence suggests that antimicrobial stewardship interventions are associated with improved intended outcomes, mostly antimicrobial usage, over short time periods (1-3 years) • The literature supports hospital and healthcare system implementation of sensible, practical antimicrobial stewardship interventions to improve outcomes Evidence-based Synthesis Program (ESP) Recommendations • Data on antimicrobial use by clinical unit, type of patients, provider groups, and by individual providers should be gathered to determine where antimicrobial use might be less than ideal or is in need of improvement Evidence-based Synthesis Program (ESP) Recommendations • Existing infection prevention programs, microbiology laboratories, pharmacy services, infectious disease physicians, electronic medical record systems, continuous improvement programs, and staff or trainee education and certification programs should be utilized to contribute to stewardship activities • Leadership should also be informed and involved in planning; leadership support is essential Evidence-based Synthesis Program (ESP) Recommendations • Formative evaluation should be used to identify effective stewardship programs and programs in need of modification Evidence-based Synthesis Program (ESP)

Timothy J Wilt

Papers

Systematic Review of Prognostic Tests

Deciding what type of evidence and outcomes to include in guidelines: article 5 in Integrating and coordinating efforts in COPD guideline development. An official ATS/ERS workshop report.

Prostate Cancer Screening: Practice What the Evidence Preaches

Expanded Access to Lung Cancer Screening—Implementing Wisely to Optimize Health

Antimicrobial Stewardship Programs in Inpatient Settings