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Comparative Effectiveness Research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care. Evidence is generated through research that uses various study designs (e.g., observational, clinical trial) and synthesized through systematic reviews.

What is Comparative Effectiveness Research?

Comparative Effectiveness Research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition, or to improve the delivery of care.

Evidence is generated through research that uses various study designs (e.g., observational, clinical trial) and synthesized through systematic reviews.

The purpose of CER, as stated by the Institute of Medicine in its 2009 report on Initial National Priorities for Comparative Effectiveness Research , is to assist consumers, clinicians, purchasers and policy makers in making informed decisions that will improve health care at both the individual and population levels.

CER addresses issues of relative effectiveness (comparing two or more tests, treatments/interventions, care delivery systems, or policies of interest). CER generally does not include placebo-controlled trials and often focuses on broader, more heterogeneous populations (i.e., "real world" populations).

The goal of CER is to provide stakeholders (patients, caregivers, providers, payers, policy makers) with information that can be used to make decisions about the benefits/tradeoffs between two or more tests, treatments/interventions, care delivery systems, or policies. As such, stakeholder engagement is often a part of the research process and the outcomes of CER should be relevant to these stakeholders. Dissemination of findings in a manner that is useful for stakeholders is also an important aspect of CER.

The Agency for Healthcare Research and Quality ( AHRQ ) identifies the following seven steps involved in conducting comparative effectiveness research:

• Identify new and emerging clinical interventions.
• Review and synthesize current medical research.
• Identify gaps between existing medical research and the needs of clinical practice.
• Promote and generate new scientific evidence and analytic tools.
• Train and develop clinical researchers.
• Translate and disseminate research findings to diverse stakeholders.
• Reach out to stakeholders via a citizens forum.

Patient-centered outcomes research (PCOR), a term closely related to CER, is defined as "research that helps people and their caregivers communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options." ( PCORI )

Why is CER important?

Comparative effectiveness research is designed to improve health care decision-making by providing evidence about the effectiveness, benefits and harms of different treatment options.

Although clinical trials conducted during the drug development process do provide evidence about the effectiveness of new medications, these studies are based on a small number of patients that meet a rigorous set of study entry criteria.

Both the European Medicines Agency and the FDA acknowledge the need for studies that examine the effectiveness of a drug in the 'real world'. Such studies tend to be large (to assess rare events and subgroup effects) and generalizable. They are also clinically more relevant because they address the question of which of the available treatments is best for a specific patient rather than the question whether a treatment works or not.

While these comparative effectiveness studies can be randomized studies, the great majority are not. Many rely on already collected data from large, automated healthcare databases.

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Comparative Effectiveness Research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor a clinical condition or improve care delivery. It is the methodology that determines what works best in medicine.

The goal of Comparative Effectiveness Research is to generate better information about the risks, benefits, and costs of different treatment options to provide healthcare decision-makers—including patients, clinicians, purchasers, and policymakers—with up-to-date, evidence-based information about their treatment options to make informed health care decisions.

Stakeholder engagement is often a part of the research process, and the outcomes of Comparative Effectiveness Research should be relevant to these stakeholders. Dissemination of findings in a manner that is useful for stakeholders is also an important aspect of Comparative Effectiveness Research.

Clinical Futures Projects Involving Pediatric Comparative Effectiveness Methodology:

Broad- vs. narrow-spectrum antibiotics for acute upper respiratory tract infections.

This  study , published in the Journal of the American Medical Association, found that narrow-spectrum antibiotics performed equally well or better than broad-spectrum antibiotics when assessed by both practical and clinical outcomes for acute upper respiratory tract infections (ARTIs). Specifically, children receiving narrow-spectrum antibiotics had a higher health-related quality of life and a reduced risk of antibiotic side effects as compared to children receiving broad-spectrum antibiotics.  

Faculty Contributors: Louis Bell, MD, Alexander Fiks, MD, MSCE, Jeffrey Gerber, MD, PhD, Julia Szymczak, PhD

PKIDS Care Improvement Network

Kidney stones are one of the fastest growing health conditions among children, adolescents, and young adults. The Pediatric KIDney Stone (PKIDS) Care Improvement Network will compare three approaches to removing kidney stones: ureteroscopy, shockwave lithotripsy, and percutaneous nephrolithotomy. The study leverages a network of over 25 pediatric healthcare systems in North America.

Faculty Contributor: Gregory Tasian, MD, MSCE

The PROMPT BOLUS study

The PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FLUid in Sepsis ( PRoMPT BOLUS ) study will compare the effectiveness and monitor safety of two treatments approved by the FDA to reverse septic shock. Preliminary work supported the feasibility of this pragmatic trial design, which will leverage networks in the U.S., Canada, Australia, and New Zealand to enroll more than 8,000 patients at more than 40 total sites.

Faculty Contributor: Fran Balamuth, MD, PhD

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Practical Guide to Comparative Effectiveness Research Using Observational Data

• 1 Surgical Outcomes and Quality Improvement Center, Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois
• 2 Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill
• 3 Department of Surgery, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
• Editorial Maximizing the Impact of Surgical Health Services Research Amir A. Ghaferi, MD, MS; Adil H. Haider, MD, MPH; Melina R. Kibbe, MD JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Qualitative Analysis Margaret L. Schwarze, MD, MPP; Amy H. Kaji, MD, PhD; Amir A. Ghaferi, MD, MS JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Mixed Methods Lesly A. Dossett, MD, MPH; Amy H. Kaji, MD, PhD; Justin B. Dimick, MD, MPH JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Cost-effectiveness Analysis Benjamin S. Brooke, MD, PhD; Amy H. Kaji, MD, PhD; Kamal M. F. Itani, MD JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Health Policy Evaluation Using Observational Data John W. Scott, MD, MPH; Todd A. Schwartz, DrPH; Justin B. Dimick, MD, MPH JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Survey Research Karen Brasel, MD, MPH; Adil Haider, MD, MPH; Jason Haukoos, MD, MSc JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Meta-analysis Shipra Arya, MD, SM; Todd A. Schwartz, DrPH; Amir A. Ghaferi, MD, MS JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Assessment of Patient-Reported Outcomes Giana H. Davidson, MD, MPH; Jason S. Haukoos, MD, MSc; Liane S. Feldman, MD JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Implementation Science Heather B. Neuman, MD, MS; Amy H. Kaji, MD, PhD; Elliott R. Haut, MD, PhD JAMA Surgery
• Guide to Statistics and Methods Practical Guide to Decision Analysis Dorry L. Segev, MD, PhD; Jason S. Haukoos, MD, MSc; Timothy M. Pawlik, MD, MPH, PhD JAMA Surgery

Evidence-based medicine in surgery is essential to the delivery of high-quality care. Comparative effectiveness research (CER) using observational study designs refers to the wide scope of research that allows for the generation of evidence to support one care strategy over another. Comparative effectiveness research is defined by the Institute of Medicine as the “generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.” 1 The purpose of CER is to provide actionable evidence to consumers, clinicians, purchasers, and policy makers to make informed decisions. 1

• Editorial Maximizing the Impact of Surgical Health Services Research JAMA Surgery

Read More About

Merkow RP , Schwartz TA , Nathens AB. Practical Guide to Comparative Effectiveness Research Using Observational Data. JAMA Surg. 2020;155(4):349–350. doi:10.1001/jamasurg.2019.4395

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Methods Guide for Effectiveness and Comparative Effectiveness Reviews [Internet]

• PMID: 21433403
• Bookshelf ID: NBK47095

Comparative Effectiveness Reviews are systematic reviews of existing research on the effectiveness, comparative effectiveness, and harms of different health care interventions. They provide syntheses of relevant evidence to inform real-world health care decisions for patients, providers, and policymakers. Strong methodologic approaches to systematic review improve the transparency, consistency, and scientific rigor of these reports. Through a collaborative effort of the Effective Health Care (EHC) Program, the Agency for Healthcare Research and Quality (AHRQ), the EHC Program Scientific Resource Center, and the AHRQ Evidence-based Practice Centers have developed a Methods Guide for Comparative Effectiveness Reviews. This Guide presents issues key to the development of Comparative Effectiveness Reviews and describes recommended approaches for addressing difficult, frequently encountered methodological issues.

The Methods Guide for Comparative Effectiveness Reviews is a living document, and will be updated as further empiric evidence develops and our understanding of better methods improves. Comments and suggestions on the Methods Guide for Comparative Effectiveness Reviews and the Effective Health Care Program can be made at www.effectivehealthcare.ahrq.gov .

• Comparing Medical Interventions: AHRQ and the Effective Health Care Program
• Principles in Developing and Applying Guidance
• Identifying, Selecting, and Refining Topics
• Developing and Selecting Topic Nominations for Systematic Reviews
• The Refinement of Topics for Systematic Reviews: Lessons and Recommendations From the Effective Health Care Program
• Finding Evidence for Comparing Medical Interventions
• Finding Grey Literature Evidence and Assessing for Outcome and Analysis Reporting Biases When Comparing Medical Interventions: AHRQ and the Effective Health Care Program
• Avoiding Bias in Selecting Studies
• Selecting Observational Studies for Comparing Medical Interventions
• Assessing the Risk of Bias in Systematic Reviews of Health Care Interventions
• Assessing the Applicability of Studies When Comparing Medical Interventions
• Prioritization and Selection of Harms for Inclusion in Systematic Reviews
• Assessing Harms When Comparing Medical Interventions
• Quantitative Synthesis—An Update
• Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective Health Care Program of the Agency for Healthcare Research and Quality: An Update
• Using Existing Systematic Reviews To Replace De Novo Processes in Conducting Comparative Effectiveness Reviews
• Integrating Bodies of Evidence: Existing Systematic Reviews and Primary Studies
• Updating Comparative Effectiveness Reviews: Current Efforts in AHRQ’s Effective Health Care Program
• Guidance for the Conduct and Reporting of Modeling and Simulation Studies in the Context of Health Technology Assessment

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Research Article

Comparative Effectiveness Research: An Empirical Study of Trials Registered in ClinicalTrials.gov

* E-mail: [email protected]

Affiliations Division of Emergency Medicine, Children's Hospital Boston, Boston, Massachusetts, United States of America, Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, United States of America

Affiliation Department of Pediatrics, Hospital for Sick Children, Toronto, Canada

Affiliations Division of Emergency Medicine, Children's Hospital Boston, Boston, Massachusetts, United States of America, Department of Pediatrics, Harvard Medical School, Boston, Massachusetts, United States of America, Children's Hospital Informatics Program at the Harvard-MIT Division of Health Sciences and Technology, Children's Hospital Boston, Boston, Massachusetts, United States of America

• Florence T. Bourgeois, 
• Srinivas Murthy, 
• Kenneth D. Mandl

• Published: January 9, 2012
• https://doi.org/10.1371/journal.pone.0028820
• Reader Comments

The $1.1 billion investment in comparative effectiveness research will reshape the evidence-base supporting decisions about treatment effectiveness, safety, and cost. Defining the current prevalence and characteristics of comparative effectiveness (CE) research will enable future assessments of the impact of this program.

We conducted an observational study of clinical trials addressing priority research topics defined by the Institute of Medicine and conducted in the US between 2007 and 2010. Trials were identified in ClinicalTrials.gov. Main outcome measures were the prevalence of comparative effectiveness research, nature of comparators selected, funding sources, and impact of these factors on results.

231 (22.3%; 95% CI 19.8%–24.9%) studies were CE studies and 804 (77.7%; 95% CI, 75.1%–80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%–39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%–44.1%) no control. The most common treatments examined in CE studies were drug interventions (37.2%), behavioral interventions (28.6%), and procedures (15.6%). Study findings were favorable for the experimental treatment in 34.8% of CE studies and greater than twice as many (78.6%) non-CE studies (P<0.001). CE studies were more likely to receive government funding (P = 0.003) and less likely to receive industry funding (P = 0.01), with 71.8% of CE studies primarily funded by a noncommercial source. The types of interventions studied differed based on funding source, with 95.4% of industry trials studying a drug or device. In addition, industry-funded CE studies were associated with the fewest pediatric subjects (P<0.001), the largest anticipated sample size (P<0.001), and the shortest study duration (P<0.001).

Conclusions

In this sample of studies examining high priority areas for CE research, less than a quarter are CE studies and the majority is supported by government and nonprofits. The low prevalence of CE research exists across CE studies with a broad array of interventions and characteristics.

Citation: Bourgeois FT, Murthy S, Mandl KD (2012) Comparative Effectiveness Research: An Empirical Study of Trials Registered in ClinicalTrials.gov. PLoS ONE 7(1): e28820. https://doi.org/10.1371/journal.pone.0028820

Editor: Laxmaiah Manchikanti, University of Louisville, United States of America

Received: October 24, 2011; Accepted: November 15, 2011; Published: January 9, 2012

Copyright: © 2012 Bourgeois et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Funding: Dr. Bourgeois was supported by a training grant (5T32HD040128) from the National Institute of Child Health and Human Development, and Dr. Mandl by a grant from the National Library of Medicine (5G08LM009778), National Institutes of Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

Introduction

Comparative effectiveness (CE) research is the “generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat and monitor health conditions in ‘real world’ settings”. [1] Recognizing that the evidence-base for the practice of medicine is often built on studies lacking active comparators and therefore falls short in supporting either high quality care or healthcare reform, there is now substantial focus on and investment in CE research. [2] In the United Kingdom, for instance, the National Institute for Health and Clinical Excellence compiles and disseminates CE and cost-effectiveness data to support diagnostic and therapeutic decisions. [3] , [4] Similar agencies in Canada and Australia—the Common Drug Review and the Pharmaceutical Benefits Advisory Committee, respectively—provide information on the effectiveness and cost of pharmaceuticals, specifically, compared to relevant alternatives. [5] , [6] , [7]

In the United States, CE research was recently appropriated $1.1 billion through the American Recovery and Reinvestment Act of 2009. [1] , [8] This funding reflects the growing awareness that improved data is needed on the relative benefits of therapies to enable patients and clinicians to make informed decisions and to reduce gross geographic variations in healthcare allocations seen across the United States. [9] , [10]

In order to envision how the evolution of CE research will shape the evidence-base for future healthcare delivery, we sought to leverage a novel data source of clinical trials—the web-based registry ClinicalTrials.gov—and measure the prevalence of CE research and characterize current CE research activity. We focus our empirical study on research conducted in the United States where the concerted effort to expand CE research has not yet had a substantial impact on studies performed. Specifically, we examine research areas highlighted in the 2009 Institute of Medicine (IOM) list of 100 priority topics deemed to be most pertinent to improving the health of the population, commissioned by the United States Congress to inform the initial investment in CE research. [11] Since we focus on research activity in the United States, we limit our study to trials registered in ClinicalTrials.gov, which is the primary registry employed by investigators in the United States and which has previously been used to define and study large trial cohorts. [12] , [13] To begin to anticipate the impact of the investment in CE research, we determine the prevalence of CE research to date, the types of interventions studied, and the role of funding sources sponsoring CE research.

Selection of Clinical Studies

We examined the 15 research areas among the top 25 topics on the IOM list of priority areas that addressed specific diseases or conditions as opposed to strategies for delivering care or diagnostic and treatment approaches for broad groups of conditions ( Table S1 ). [11] We identified studies pertaining to these research areas in ClinicalTrials.gov, selecting trials that were registered between January 1, 2007 and April 26, 2010 (date of data download from ClinicalTrials.gov) and that were conducted in the United States ( Figure 1 ).

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Selection of trials in ClinicalTrials.gov that address 15 research topics identified by the Institute of Medicine as being top priority for comparative effectiveness research.

https://doi.org/10.1371/journal.pone.0028820.g001

ClinicalTrials.gov is a web-based registry of clinical studies that provides a publicly available source of information on clinical studies conducted in the United States and internationally. [14] In 2005, the International Committee of Medical Journal Editors instituted a policy requiring prospective registration of all trials—regardless of intervention type—as a prerequisite for publication, resulting in a dramatic increase in the registration of trials and sustained wide-spread use since then. [15] , [16] In addition, under the FDA Amendments Act of 2007, the FDA requires the registration in ClincialTrials.gov of all clinical investigations (except phase I trials) of a drug, biologic, or device that is subject to FDA regulation, regardless of trial design. [17] Users can query the registry and identify specific types of trials using a search function that includes keyword searches. We employed keywords identified from published systematic reviews on the diseases or conditions of interest ( Table S1 ). Studies selected using this search strategy were individually reviewed and those included that directly addressed the research topics of interest.

Definitions and Data Extraction

CE studies were defined as those comparing the experimental intervention to another active therapy as opposed to a placebo control or no comparator. [18] Both the experimental treatment and the comparator were classified as an intervention involving a drug, device, procedure, behavioral change, or other treatment (e.g. dietary supplement). Active comparator studies were defined as studies that compared two treatment alternatives, including “optimal usual care” when these reflected appropriate current practice and standards. [2] , [11] In determining the type of comparator employed, we did not rely on the investigator-assigned study labels in ClinicalTrials.gov but rather examined the detailed description of the study in the record.

The data elements obtained from the ClincialTrials.gov entry and recorded for each study were registration date, study start and completion dates, experimental treatment under study, comparator type, trial phase for drug and device studies, funding source, outcome measures, anticipated enrollment number, subject age groups, and elements of the study design.

Study outcome measures are specifically listed in the study record as primary and secondary outcomes and we determined whether these included measures of safety, including any side effects, adverse events, or other potential harms or risks related to the intervention, or cost assessments, including formal cost-analyses and general measures of resource utilization. For 17 studies that did not include specific outcome measures in the study record, we reviewed the study descriptions to identify the inclusion of safety and cost assessments.

Funding source was classified as government, industry, or nonprofit based on the funding sponsors listed in the record. We categorized “NIH”, “U.S. federal”, and “other government” as government funding; “industry” as industry funding; and “network”, “individual”, and “other” (which includes universities, hospitals, foundations, and other nonprofit organizations) as nonprofit funding. [12] We applied this classification to primary and secondary funding sources. Subject ages are categorized in the registry as “Child” (up to 17 years), “Adult” (18 to 65 years), “Senior” (66 years and older), and combinations of these groups. We re-coded these data into a three-level variable of children only, children and adults/seniors, and adults/seniors.

Classification of experimental intervention, comparator type, and safety and cost assessments were performed independently by two of the authors (F.B. and S.M.) and disagreements resolved by consensus.

Assessment of Study Outcomes

Publications associated with studies were identified using a previously described method. [12] Briefly, for studies that did not include results or a reference to a publication within the CinicalTrials.gov record, four electronic databases were searched. These included PubMed, the Cochrane Library, EMBASE, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). All searches were finalized by August 31, 2010. Each publication was reviewed and the results for the primary outcome classified as favorable (i.e. statistically significant based on P values or confidence intervals) or not favorable (i.e. not statistically significant) for the experimental treatment. For studies without a comparator or statistical analysis, the classification was based on the interpretation of the results provided in the study conclusions. Publications that did not describe results pertaining to the efficacy or safety of the intervention were classified as “neither”. Two of the authors (F.B. and S.M.) independently performed the outcome classification and resolved disagreements by consensus. Inter-coder agreement for assigning study outcomes was good with a kappa of 0.78 (95% CI, 0.65–0.91).

Statistical Analysis

We calculated the proportion of studies that were CE studies and compared study characteristics for CE and non-CE studies. Sub-analyses were performed on CE studies based on funding source. Trials examining a pharmaceutical intervention were also specifically examined and CE and non-CE studies compared. Chi-square and Kruskal-Wallis tests were used to compare categorical and median values, respectively. We used the Cochran-Mantel-Haenszel test to control for funding source when examining study outcomes. All data were analyzed with SAS software (version 9.2, SAS Institute Inc., Cary, North Carolina).

Of the 3167 studies retrieved from ClinicalTrials.gov, 1035 were included in the final study sample after reviewing the study description ( Figure 1 ). Among these, 231 (22.3%; 95% confidence interval [CI], 19.8%–24.9%) were CE studies and 804 (77.7%; 95% CI, 75.1%–80.2%) were non-CE studies, with 379 (36.6%; 95% CI, 33.7%–39.6%) employing a placebo control and 425 (41.1%; 95% CI, 38.1%–44.1%) no control.

Study characteristics are presented in Table 1 . In half the studies examined (49.9%), the experimental treatment consisted of a pharmacological therapy and in 18.3% a behavioral intervention. The distribution of experimental treatments differed for the different study types, with drug treatments more likely to be studied with a placebo or no intervention (P<0.001). Studies with active comparators were more likely to be in advanced phases (Phase 3 or 4; P<0.001), to employ larger sample sizes (P<0.001), and to be longer in duration (P = 0.02). Fewer studies with active comparators included a primary safety outcome (8.2% vs. 14.0% and 23.8% for placebo-controlled and no comparator studies; P<0.001) and only 3.5% included a cost assessment.

https://doi.org/10.1371/journal.pone.0028820.t001

Impact of Funding Source on Characteristics of CE Studies

The distribution of primary funding sources was similar among CE and non-CE studies ( Table 2 ). Overall, 71.8% (n = 166) of CE studies were funded by non-commercial sources, including government and nonprofit organizations. CE studies were more likely to include government funding (32.5% compared with 22.9% of non-CE studies, P = 0.003) and less likely to include industry funding (37.2% compared with 46.4% of non-CE studies, P = 0.01).

https://doi.org/10.1371/journal.pone.0028820.t002

We further examined study interventions and other characteristics for CE studies based on funding source ( Table 3 ). Among CE studies funded primarily by industry, 95.4% involved the study of a drug or device and most compared the intervention to another drug or device (90.8%). Primarily industry-funded CE studies involved the largest anticipated sample size (median of 324 subjects vs. 175 and 100 subjects for government and nonprofit funding, respectively; P<0.001), were the least likely to enroll pediatric subjects (7.6% vs. 37.5% and 17.3% for government and nonprofit funding, respectively; P<0.001), and were the shortest in duration (median length 1.8 years vs. 3.0 and 2.4 years for government and nonprofit funding, respectively; P<0.001).

https://doi.org/10.1371/journal.pone.0028820.t003

Studies with any type of government funding were less likely to study a drug or device (P<0.001) and more likely to include children (P<0.001) and be longer in duration (P<0.001). Government funding was not associated with an increase in the study of safety or cost outcomes.

Pharmaceutical and Device Studies and CE Research

Among the subset of 516 studies examining a pharmaceutical intervention, 86 (16.7%; 95% CI, 13.4%–19.9%) were CE studies and 430 (83.3%; 95% CI, 80.1%–86.6%) were non-CE studies.

Government sources provided primary funding for 11.6% (n = 10) and industry for 52.3% (n = 45) of CE drug studies ( Table 4 ). CE studies were less likely to include a safety outcome compared with non-CE studies (P<0.001), involved larger anticipated sample sizes (median of 238 subjects vs. 80 subjects; P<0.001), and were less likely to be double-blinded (66.7% vs. 92.7%; P<0.001). Device studies included 32 (26.4%; 95% CI, 18.6%–34.3%) CE studies and 89 (73.6%; 95% CI, 65.7%–81.4%) non-CE studies. Government was the primary funding source for 6.2% (n = 2) and industry 53.1% (n = 17) of the CE device studies.

https://doi.org/10.1371/journal.pone.0028820.t004

CE Study Outcomes

Results were identified for 115 (11.1%) studies. A total of 8/23 (34.8%) reports described positive findings for studies with active controls compared with 66/84 (78.9%) among non-CE studies (12/32 [73.9%] placebo-controlled trials and 6/32 [84.2%] trials without controls) (P<0.001). Among trials primarily funded by industry, 33/41 (80.5%) reported positive findings compared with 41/66 (61.7%) among all others (P = 0.04). After controlling for primary funding source, CE studies remained less likely to report positive findings (P<0.007 for Cochran-Mantel-Haenszel test). Among CE studies involving a drug therapy, findings were positive for 30.0% (n = 3) of CE studies compared with 81.6% (n = 40) of non-CE studies (P<0.001, Cochran-Mantel-Haenszel test controlling for primary funding source). None of the CE studies examining devices and 71.4% (n = 5) of non-CE studies involving devices reported findings favorable for the device (P = 0.04).

We provide a benchmark for the current state of CE research, demonstrating that for conditions deemed as highest priority by the IOM, less than a quarter of studies examined comparative effectiveness. The majority of CE studies were funded by government and nonprofit sources and outcomes were less likely to be positive for the experimental intervention among CE trials compared with non-CE trials. Funding sources had a substantial impact on the characteristics of CE studies, with industry-funded trials focusing primarily on drugs and devices and those funded by noncommercial sources addressing more diverse types of interventions. Industry-funded trials also differed in trial design with larger sample sizes, fewer studies involving pediatric patients, and shorter study periods.

Only a small proportion of CE studies address safety and cost outcomes, highlighting an opportunity for government-sponsored CE research to play a significant role. [2] , [19] , [20] , [21] Regardless of funding source, CE studies are less likely to examine safety outcomes, particularly among drug studies, demonstrating an emphasis on measuring treatment efficacy over measuring treatment risks and adverse events. Cost assessments are currently rare for both CE and non-CE studies across all funding sources.

Hochman et al previously found low prevalence of CE studies and a higher rate of positive outcomes among non-CE studies of pharmaceuticals compared with CE studies. [18] Using a comprehensive and growing data source of recent and ongoing research activity, our results corroborate those findings. We further demonstrate that the low prevalence of CE research and differences in outcomes exist across CE studies with a broad array of interventions and that characteristics of CE studies vary substantially based on the funding source sponsoring the study.

With an ever-expanding list of diagnostic and therapeutic options, CE studies fill an important gap in informing clinicians whether an intervention is superior to existing and familiar alternatives. Our findings suggest characteristics of CE research that may produce specific shifts in the evidence-base towards more critical and comprehensive assessments of the intervention under study. From our findings, we extrapolate that the projected increase in the number of CE studies—particularly studies of drugs and devices funded by noncommercial sources—will increase the proportion of studies that fail to support adoption of the experimental treatment. We base this prediction on two findings.

The first is that CE studies are less likely than non-CE studies to report results that promote the use of the experimental intervention, reinforcing that this study design may produce more conservative results in terms of the superiority of a therapy compared to other treatments. Trials with inactive comparators have previously been shown to have a greater likelihood of achieving favorable findings. [18] , [22] , [23] Drug and device studies that employ non-active comparators and yield favorable outcomes may encourage the adoption and use of the experimental intervention even though information is lacking on how the drug or device compares to current standards of care. [23]

Secondly, while noncommercial sources funded 71% of CE studies overall, industry funded the majority of CE drug and device studies, which biases toward results supporting the use of a product. [24] , [25] , [26] , [27] Industry trials investigating drugs and devices are typically designed and conducted by the company marketing the product and there is substantial and well-documented evidence that these studies are more likely to report findings supporting the efficacy and safety of the product than noncommercially funded studies. [12] , [24] , [25] , [28] , [29] , [30] In our study sample, industry-funded studies were more likely to report an outcome favoring the use of the intervention than noncommercially-funded studies, and only 17% of drug studies and 26% of device studies used an active comparator. Research on drugs and devices would benefit from greater participation of non-stakeholders—such as government sponsors—as well as greater oversight in study design in order to ensure rigorous and valid assessments of the effectiveness of these treatments. [31]

There are several factors critical to ensuring the success of the new CE research initiative and the ability of CE research to improve clinical decision-making. Methodologically, CE studies must be large enough and have a sufficient patient follow up period to demonstrate not only equivalence, but superiority of one treatment compared to another. [32] Randomized controlled trials, which are typically designed to ascertain the efficacy of an intervention in select patient populations and tightly controlled settings, may not reflect real-world outcomes or be generalizable to routine clinical practice, which is one of the defining principles of CE research. By contrast, pragmatic clinical trials and observational studies may provide results that are directly pertinent to clinicians and patients choosing between available therapies. [33] In addition, comparative efficacy data must be timely and available prior to the widespread adoption of new products or interventions, as the lack of comparative evidence has resulted in the extensive use of a number of treatments later found to be less efficacious or safe than existing alternatives. [20] , [31]

A limitation of our study is that outcomes data are not available for all studies since we chose to examine recent and ongoing studies, in order to ensure that our findings are most pertinent to the current state of CE research. However, it is unlikely that systematic bias produced our finding that CE studies are more likely to yield favorable outcomes. This finding is supported in prior literature and the sample of published results is of sufficient magnitude to demonstrate important and statistically significant differences in reported outcomes. [18] , [22] We were not able to verify the accuracy of data provided by investigators, but information such as experimental treatment, comparator type, and funding source, are likely properly and reliably reported. Finally, there are some missing data in ClincialTrials.gov, including anticipated sample size for 1% of trials and study duration for 17% of trials.

In conclusion, less than a quarter of studies use an active comparator to measure the CE of the treatment under investigation. Based on outcomes reported in CE and non-CE studies, CE studies in general appear to provide more rigorous assessments of the interventions under study. Boosting noncommercial funding of CE studies may be particularly critical to drug and device studies in order to ensure unbiased data on how the intervention compares to other available treatments. Further study is necessary to understand the impact of CE research on healthcare reform and cost, as there is a risk when new treatments face a higher barrier to acceptance that some innovation may be slowed and development costs increased. On the other hand, we can expect that CE research will provide physicians and patients with substantially stronger evidence about which therapies are effective.

Supporting Information

Study Topics and Keywords for Study Selection. Clinical trials examined in the study pertained to these 15 research areas. The corresponding keywords were used to identify the trials in ClinicalTrials.gov using the embedded search function.

https://doi.org/10.1371/journal.pone.0028820.s001

Acknowledgments

We would like to thank Professor Enrico Coiera, director of the Centre for Health Informatics, University of New South Wales, for his time in providing an insightful critical review of the manuscript.

Author Contributions

Conceived and designed the experiments: FTB SM KDM. Performed the experiments: FTB SM. Analyzed the data: FTB SM. Contributed reagents/materials/analysis tools: FTB SM KDM. Wrote the paper: FTB SM KDM.

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A Comparative Analysis of Gamified and Non-gamified Interventions’ Effectiveness in Teaching Adolescent Students About Healthy Sexual Practices in Tanzania

• Published: 27 March 2024

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• Hussein Haruna   ORCID: orcid.org/0000-0001-9089-2847 1  

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Introduction

This study primarily evaluated the effectiveness of gamified learning particularly serious game and gamification platforms aimed to improve sexual health education in a resource-limited setting of Tanzania. The need for the study arose because many adolescent students have little knowledge on sexual and reproductive health, which makes them vulnerable to engaging in unhealthy and high-risk sexual practices, hence prompting global public health researchers to find innovative approaches to addressing the problem.

The study applied a participatory research design that involved active users and other key stakeholders in developing the “My Future Begins Today” digital game. A quasi-experiment-controlled study enabled the use of two gamified learning conditions—serious game and gamification platforms—with a traditional non-gamified teaching method) serving as control. In all, 108 students aged 11–15 drawn from one secondary school in Dar es Salaam, Tanzania, participated in a series of sexual health education. The age mean of participants was 13, whereby males were 61 (56.5%) and females were 47 (43.5%). Results: Overall, the gamified learning students demonstrated a significant improvement in knowledge acquisition and change of attitude on all five topics of sexual health education than the non-gamified students: F (2, 105) = 71.866, p  < .001). Moreover, the gamified students perceived more positively over the whole MAKE evaluation than the non-gamified students ( p  < .001).

The study found that gamified systems can effectively reduce risky sexual behaviours and improve health outcomes by providing meaningful knowledge through activities, competitions, awards, and leaderboards, which are otherwise unavailable in non-gamified classes.

Policy Implications

Innovative teaching strategies like gamified learning can help decision-makers and policymakers create guidelines and regulations that improve services for adolescents’ sexual and reproductive health.Thus, this study has demonstrated how gamified can impact teenagers’ sexual behaviour decision-making and support cognitive development.

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Haruna, H. A Comparative Analysis of Gamified and Non-gamified Interventions’ Effectiveness in Teaching Adolescent Students About Healthy Sexual Practices in Tanzania. Sex Res Soc Policy (2024). https://doi.org/10.1007/s13178-024-00961-0

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Comparative effectiveness research is designed to inform health-care decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options. The evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care.

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• 269. Respectful Maternity Care: Dissemination and Implementation of Perinatal Safety Culture To Improve Equitable Maternal Healthcare Delivery and Outcomes
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• 266. Cervical Degenerative Disease Treatment: A Systematic Review
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• 253. Maternal and Child Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)
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• 249. Malnutrition in Hospitalized Adults: A Systematic Review
• 248. Prehabilitation and Rehabilitation for Major Joint Replacement
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• 240. Treatments for Acute Pain: A Systematic Review
• 239. Acute Treatments for Episodic Migraine
• 238. Cervical Ripening in the Outpatient Setting
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• 236. Maternal, Fetal, and Child Outcomes of Mental Health Treatments in Women: A Systematic Review of Perinatal Pharmacologic Interventions
• 235. Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD-Repository Evidence Base
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• 226. Labor Dystocia
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• 224. Treatment of Depression in Children and Adolescents: A Systematic Review
• 223. Diagnosis and Treatment of Clinical Alzheimer’s-Type Dementia: A Systematic Review
• 222. Achieving Health Equity in Preventive Services
• 221. Pharmacologic and Nonpharmacologic Therapies in Adult Patients With Exacerbation of COPD: A Systematic Review
• 220. Comparative Effectiveness of Analgesics To Reduce Acute Pain in the Prehospital Setting
• 219. Antipsychotics for the Prevention and Treatment of Delirium
• 218. Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review
• 216. Telehealth for Acute and Chronic Care Consultations
• 215. Adverse Effects of Pharmacologic Treatments of Major Depression in Older Adults
• 214. Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update
• 213. Lower Limb Prostheses: Measurement Instruments, Comparison of Component Effects by Subgroups, and Long-Term Outcomes
• 212. Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update
• 211. Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update
• 210. Breastfeeding Programs and Policies, Breastfeeding Uptake, and Maternal Health Outcomes in Developed Countries
• 209. Noninvasive Nonpharmacological Treatment for Chronic Pain: A Systematic Review
• 208. Treatment for Bipolar Disorder in Adults: A Systematic Review
• 207. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder: A Systematic Review Update
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• 205. Physiologic Predictors of Severe Injury: Systematic Review
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• 203. Attention Deficit Hyperactivity Disorder: Diagnosis and Treatment in Children and Adolescents
• 202. Effectiveness and Safety of Bronchial Thermoplasty in Management of Asthma
• 201. Effectiveness of Indoor Allergen Reduction in Management of Asthma
• 200. Diagnostic Accuracy of Screening and Treatment of Post–Acute Coronary Syndrome Depression: A Systematic Review
• 199. Treatments for Basal Cell and Squamous Cell Carcinoma of the Skin
• 198. Treatments for Schizophrenia in Adults: A Systematic Review
• 197. The Clinical Utility of Fractional Exhaled Nitric Oxide (FeNO) in Asthma Management
• 196. The Role of Immunotherapy in the Treatment of Asthma
• 195. Management of Uterine Fibroids
• 194. Intermittent Inhaled Corticosteroids and Long-Acting Muscarinic Antagonists for Asthma
• 193. Management of Suspected Opioid Overdose With Naloxone by Emergency Medical Services Personnel
• 192. Anxiety in Children
• 191. Venous Thromboembolism Prophylaxis in Major Orthopedic Surgery: Systematic Review Update
• 190. Treatment of Osteoarthritis of the Knee: An Update Review
• 189. Medical Therapies for Children With Autism Spectrum Disorder—An Update
• 188. Interventions to Prevent Age-Related Cognitive Decline, Mild Cognitive Impairment, and Clinical Alzheimer’s-Type Dementia
• 187. Preventing Complications and Treating Symptoms of Diabetic Peripheral Neuropathy
• 186. Interventions Targeting Sensory Challenges in Children With Autism Spectrum Disorder—An Update
• 185. Tympanostomy Tubes in Children With Otitis Media
• 184. First- and Second-Generation Antipsychotics in Children and Young Adults: Systematic Review Update
• 183. Tonsillectomy for Obstructive Sleep-Disordered Breathing or Recurrent Throat Infection in Children
• 182. Glasgow Coma Scale for Field Triage of Trauma: A Systematic Review
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• 180. Strategies To De-escalate Aggressive Behavior in Psychiatric Patients
• 179. Renal Artery Stenosis Management Strategies: An Updated Comparative Effectiveness Review
• 178. Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostaic Hyperplasia: A Review
• 177. Nonpharmacologic Interventions for Agitation and Aggression in Dementia
• 176. Management of Gout
• 175. Total Worker Health ®
• 174. Imaging for the Pretreatment Staging of Small Cell Lung Cancer
• 173. Diabetes Medications for Adults With Type 2 Diabetes: An Update
• 172. Early Diagnosis, Prevention, and Treatment of Clostridium difficile : Update
• 171. Noninvasive Testing for Coronary Artery Disease
• 170. Improving Cultural Competence to Reduce Health Disparities
• 169. Noninvasive Treatments for Low Back Pain
• 168. Diagnosis and Management of Infantile Hemangioma
• 167. Management of Renal Masses and Localized Renal Cancer
• 166. Calcineurin Inhibitors for Renal Transplant
• 165. Treatments for Fecal Incontinence
• 164. Home-Based Primary Care Interventions
• 163. Improving Antibiotic Prescribing for Uncomplicated Acute Respiratory Tract Infections
• 162. Diagnosis of Celiac Disease
• 161. Nonpharmacological Versus Pharmacological Treatments for Adult Patients With Major Depressive Disorder
• 160. Management and Outcomes of Binge-Eating Disorder
• 159. Management of Insomnia Disorder
• 158. Diagnosis of Gout
• 157. Diagnosis of Right Lower Quadrant Pain and Suspected Acute Appendicitis
• 156. Contrast-Induced Nephropathy: Comparative Effectiveness of Preventive Measures
• 155. Contrast-Induced Nephropathy: Comparative Effects of Different Contrast Media
• 154. Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents
• 153. Emerging Approaches to Diagnosis and Treatment of Non–Muscle-Invasive Bladder Cancer
• 152. Treatment of Nonmetastatic Muscle-Invasive Bladder Cancer
• 151. Management of Postpartum Hemorrhage
• 150. Decisional Dilemmas in Discontinuing Prolonged Disease-Modifying Treatment for Multiple Sclerosis
• 149. Treatments for Ankyloglossia and Ankyloglossia With Concomitant Lip-Tie
• 148. Treatments for Fibromyalgia in Adult Subgroups
• 147. Menopausal Symptoms: Comparative Effectiveness of Therapies
• 146. Therapies for Clinically Localized Prostate Cancer: Update of a 2008 Systematic Review
• 145. Decision Aids for Cancer Screening and Treatment
• 144. Radiotherapy Treatments for Head and Neck Cancer Update
• 143. Imaging Techniques for the Diagnosis and Staging of Hepatocellular Carcinoma
• 142. Imaging Tests for the Staging of Colorectal Cancer
• 141. Imaging Tests for the Diagnosis and Staging of Pancreatic Adenocarcinoma
• 140. Chronic Urinary Retention: Comparative Effectiveness and Harms of Treatments
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• 138. Medication Therapy Management Interventions in Outpatient Settings
• 137. Therapies for Children With Autism Spectrum Disorder: Behavioral Interventions Update
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• 133. Transitional Care Interventions To Prevent Readmissions for People With Heart Failure
• 132. Combination Therapy Versus Intensification of Statin Monotherapy: An Update
• 131. Pharmacologic Therapies for the Management of Crohn's Disease: Comparative Effectiveness
• 130. Benefits and Harms of Routine Preoperative Testing: Comparative Effectiveness
• 129. Antiplatelet and Anticoagulant Treatments for Unstable Angina/Non–ST Elevation Myocardial Infarction
• 128. Oral Mechanical Bowel Preparation for Colorectal Surgery
• 127. Chronic Venous Ulcers: A Comparative Effectiveness Review of Treatment Modalities
• 126. Use of Natriuretic Peptide Measurement in the Management of Heart Failure
• 125. Testing of CYP2C19 Variants and Platelet Reactivity for Guiding Antiplatelet Treatment
• 124. Meditation Programs for Psychological Stress and Well-Being
• 123. Stroke Prevention in Atrial Fibrillation
• 122. Evaluation and Treatment of Tinnitus: Comparative Effectiveness
• 121. Interventions for Adult Offenders With Serious Mental Illness
• 120. Treatments for Seasonal Allergic Rhinitis
• 119. Treatment of Atrial Fibrillation
• 118. Treatment Strategies for Patients With Peripheral Artery Disease
• 117. Pulmonary Arterial Hypertension: Screening, Management, and Treatment
• 116. Pharmacologic and Mechanical Prophylaxis of Venous Thromboembolism Among Special Populations
• 115. Childhood Obesity Prevention Programs: Comparative Effectiveness Review and Meta-Analysis
• 114. Local Therapies for Unresectable Primary Hepatocellular Carcinoma
• 113. Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment: Comparative Effectiveness Update
• 112. Local Nonsurgical Therapies for Stage I and Symptomatic Obstructive Non–Small-Cell Lung Cancer
• 111. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review
• 110. Wireless Motility Capsule Versus Other Diagnostic Technologies for Evaluating Gastroparesis and Constipation: A Comparative Effectiveness Review
• 109. Interventions for the Prevention of Posttraumatic Stress Disorder (PTSD) in Adults After Exposure to Psychological Trauma
• 108. Migraine in Children: Preventive Pharmacologic Treatments
• 107. Child and Adolescent Exposure to Trauma: Comparative Effectiveness of Interventions Addressing Trauma Other Than Maltreatment or Family Violence
• 106. Efficacy and Safety of Screening for Postpartum Depression
• 105. Interventions To Improve Cardiovascular Risk Factors in People With Serious Mental Illness
• 104. Intravascular Diagnostic Procedures and Imaging Techniques Versus Angiography Alone in Coronary Artery Stenting: Comparative Effectiveness Review
• 103. Migraine in Adults: Preventive Pharmacologic Treatments
• 102. Screening for Methicillin-Resistant Staphylococcus Aureus (MRSA)
• 101. Otitis Media With Effusion: Comparative Effectiveness of Treatments
• 100. Assessment and Management of Chronic Cough
• 99. Outpatient Case Management for Adults With Medical Illness and Complex Care Needs
• 98. PCA3 Testing for the Diagnosis and Management of Prostate Cancer
• 97. Strategies to Prevent Weight Gain Among Adults
• 96. Primary Care Management of Abnormal Uterine Bleeding
• 95. Interventions to Modify Health Care Provider Adherence to Asthma Guidelines
• 94. Interventions for Feeding and Nutrition in Cerebral Palsy
• 93. Local Hepatic Therapies for Metastases to the Liver From Unresectable Colorectal Cancer
• 92. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD)
• 91. Interventions to Improve Patient Adherence to Hepatitis C Treatment: Comparative Effectiveness
• 90. Pressure Ulcer Treatment Strategies: Comparative Effectiveness
• 89. Child Exposure to Trauma: Comparative Effectiveness of Interventions Addressing Maltreatment
• 88. Evaluation and Treatment of Cryptorchidism
• 87. Pressure Ulcer Risk Assessment and Prevention: Comparative Effectiveness
• 86. Treatment for Restless Legs Syndrome
• 85. Biologic and Nonbiologic Systemic Agents and Phototherapy for Treatment of Chronic Plaque Psoriasis
• 84. Acute Migraine Treatment in Emergency Settings
• 83. Biomarkers for Assessing and Managing Iron Deficiency Anemia in Late-Stage Chronic Kidney Disease
• 82. Bariatric Surgery and Nonsurgical Therapy in Adults With Metabolic Conditions and a Body Mass Index of 30.0 to 34.9 kg/m 2
• 81. Long-Term Care for Older Adults: A Review of Home and Community-Based Services Versus Institutional Care
• 80. Strategies to Reduce Cesarean Birth in Low-Risk Women
• 79. Comparison of Characteristics of Nursing Homes and Other Residential Long-Term Care Settings for People With Dementia
• 78. Procalcitonin-Guided Antibiotic Therapy
• 77. Physical Therapy Interventions for Knee Pain Secondary to Osteoarthritis
• 76. Treatment for Hepatitis C Virus Infection in Adults
• 75. Practice-Based Interventions Addressing Concomitant Depression and Chronic Medical Conditions in the Primary Care Setting
• 74. Progestogens for Prevention of Preterm Birth
• 73. Serum Free Light Chain Analysis for the Diagnosis, Management, and Prognosis of Plasma Cell Dyscrasias
• 72. Multidisciplinary Postacute Rehabilitation for Moderate to Severe Traumatic Brain Injury in Adults
• 71. Breathing Exercises and/or Retraining Techniques in the Treatment of Asthma: Comparative Effectiveness
• 70. Surgical Options for Inguinal Hernia: Comparative Effectiveness Review
• 69. Screening for Hepatitis C Virus Infection in Adults
• 68. Noninvasive Positive-Pressure Ventilation (NPPV) for Acute Respiratory Failure
• 67. Nitrous Oxide for the Management of Labor Pain
• 66. Treatment Strategies for Women With Coronary Artery Disease
• 65. Interventions for Adolescents and Young Adults With Autism Spectrum Disorders
• 64. Screening, Behavioral Counseling, and Referral in Primary Care To Reduce Alcohol Misuse
• 63. First-Generation Versus Second-Generation Antipsychotics in Adults: Comparative Effectiveness
• 62. Treatment for Depression After Unsatisfactory Response to SSRIs
• 61. Recurrent Nephrolithiasis in Adults: Comparative Effectiveness of Preventive Medical Strategies
• 60. Treatment for Glaucoma: Comparative Effectiveness
• 59. Screening for Glaucoma: Comparative Effectiveness
• 58. Noninvasive Technologies for the Diagnosis of Coronary Artery Disease in Women
• 57. Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness
• 56. Adjuvant Treatment for Phenylketonuria (PKU)
• 55. Drug Therapy for Rheumatoid Arthritis in Adults: An Update
• 54. Drug Therapy for Psoriatic Arthritis in Adults: Update of a 2007 Report
• 53. Treatment To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis: Update of a 2007 Report
• 52. Fecal DNA Testing in Screening for Colorectal Cancer in Average-Risk Adults
• 51. Dietary Supplements in Adults Taking Cardiovascular Drugs
• 50. Antinuclear Antibody, Rheumatoid Factor, and Cyclic-Citrullinated Peptide Tests for Evaluating Musculoskeletal Complaints in Children
• 49. Venous Thromboembolism Prophylaxis in Orthopedic Surgery
• 48. Hematopoietic Stem-Cell Transplantation in the Pediatric Population
• 47. Noninvasive Diagnostic Tests for Breast Abnormalities: Update of a 2006 Review
• 46. Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression: An Update of the 2007 Comparative Effectiveness Review
• 45. Self-Measured Blood Pressure Monitoring: Comparative Effectiveness
• 44. Attention Deficit Hyperactivity Disorder: Effectiveness of Treatment in At-Risk Preschoolers; Long-Term Effectiveness in All Ages; and Variability in Prevalence, Diagnosis, and Treatment
• 43. Off-Label Use of Atypical Antipsychotics: An Update
• 42. Adjunctive Devices for Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention
• 41. Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness
• 40. Effectiveness and Safety of Antiepileptic Medications in Patients With Epilepsy
• 39. First- and Second-Generation Antipsychotics for Children and Young Adults
• 38. Analgesics for Osteoarthritis: An Update of the 2006 Comparative Effectiveness Review
• 37. Chronic Kidney Disease Stages 1–3: Screening, Monitoring, and Treatment
• 36. Nonsurgical Treatments for Urinary Incontinence in Adult Women: Diagnosis and Comparative Effectiveness
• 35. Terbutaline Pump for the Prevention of Preterm Birth
• 34. Angiotensin-Converting Enzyme Inhibitors (ACEIs), Angiotensin II Receptor Antagonists (ARBs), and Direct Renin Inhibitors for Treating Essential Hypertension: An Update
• 33. Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults
• 32. Diagnosis and Treatment of Obstructive Sleep Apnea in Adults
• 31. Effectiveness of Early Diagnosis, Prevention, and Treatment of Clostridium difficile Infection
• 30. Pain Management Interventions for Hip Fracture
• 29. Comparative Effectiveness of Management Strategies for Gastroesophageal Reflux Disease: Update
• 28. Disease-Modifying Antirheumatic Drugs (DMARDs) in Children With Juvenile Idiopathic Arthritis (JIA)
• 27. Oral Diabetes Medications for Adults With Type 2 Diabetes: An Update
• 26. Therapies for Children With Autism Spectrum Disorders
• 25. Traumatic Brain Injury and Depression
• 24. Screening and Treatment of Subclinical Hypothyroidism or Hyperthyroidism
• 23. Effectiveness of Recombinant Human Growth Hormone (rhGH) in the Treatment of Patients With Cystic Fibrosis
• 22. Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears
• 21. Comparative Effectiveness of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications vs. Usual Care
• 20. Comparative Effectiveness and Safety of Radiotherapy Treatments for Head and Neck Cancer
• 19. Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions
• 18. Comparative Effectiveness of Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease
• 17. Comparative Effectiveness of Medications To Reduce Risk of Primary Breast Cancer in Women
• 16. Comparative Effectiveness of Lipid-Modifying Agents
• 15. Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation
• 14. Comparative Effectiveness, Safety, and Indications of Insulin Analogues in Premixed Formulations for Adults With Type 2 Diabetes
• 13. Comparative Effectiveness of Therapies for Clinically Localized Prostate Cancer
• 12. Comparative Effectiveness of Treatments To Prevent Fractures in Men and Women With Low Bone Density or Osteoporosis
• 11. Comparative Effectiveness of Drug Therapy for Rheumatoid Arthritis and Psoriatic Arthritis in Adults
• 10. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs) for Treating Essential Hypertension
• 9. Comparative Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Grafting for Coronary Artery Disease
• 8. Comparative Effectiveness and Safety of Oral Diabetes Medications for Adults With Type 2 Diabetes
• 7. Comparative Effectiveness of Second-Generation Antidepressants in the Pharmacologic Treatment of Adult Depression
• 6. Efficacy and Comparative Effectiveness of Off-Label Use of Atypical Antipsychotics
• 5. Comparative Effectiveness of Management Strategies for Renal Artery Stenosis: 2007 Update
• 5. Comparative Effectiveness of Management Strategies for Renal Artery Stenosis
• 4. Comparative Effectiveness and Safety of Analgesics for Osteoarthritis
• 3. Comparative Effectiveness of Epoetin and Darbepoetin for Managing Anemia in Patients Undergoing Cancer Treatment
• 2. Effectiveness of Noninvasive Diagnostic Tests for Breast Abnormalities
• 1. Comparative Effectiveness of Management Strategies For Gastroesophageal Reflux Disease
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