What are the effects of Teach For America on Math, English Language Arts, and Science outcomes of K-12 students in the USA?

This Campbell systematic review examines the impact of Teach For America (TFA) on learning outcomes. Four studies were included in the review. Studies had to be a quantitative evaluation of the effects of TFA on K-12 student academic outcomes. Studies also had to use a research design which: 1. allowed valid causal inferences about TFA's effects, 2. targeted participants K-12 students taught by TFA corps members or TFA alumni in the USA, 3. compared TFA corps members to novice teachers, or compared TFA alumni with veteran teachers, and 4. reported at least one academic student outcome in math, ELA, or science domains. A total of 919 citations were retrieved on TFA, of which 24 studies were eligible for review. However, when the research design and study quality along with types of TFA corps members and non-TFA teachers compared were reviewed, the evidence base for estimating the effects of TFA on student academic outcomes was reduced to just four studies. There is no significant effect on reading from teaching by TFA corps members in their first or second year of teaching elementary-grade students (PreK - grade 5) compared to non-TFA teachers who are also in their first or second year of teaching elementary-grade students. There is a small positive effect for early elementary-grade students (PreK to grade 2) in reading but not in math. However, given the small evidence base, these findings should be treated with caution. Plain language summary: There are too few well-designed studies to know the effects of Teach For America on Math, English Language Arts, and Science outcomes of K-12 students in the USA: Teach For America (TFA) is an alternate route teacher preparation program that aims to address the decades-long shortage of effective teachers in many rural and urban public schools for kindergarten through 12th grade (K-12), that serve the highest proportions of high-poverty students across the USA. This review finds that there are very few studies - just four - which reliably measure the effects of TFA on learning outcomes, so that no firm conclusions may be drawn.What is this review about?: This systematic review evaluated the impact of TFA prepared teachers (corps members) relative to novice teachers and alumni relative to veteran teachers on K-12 student outcomes in math, English Language Arts (ELA), and science.What are the main findings of this review?: Studies had to be a quantitative evaluation of the effects of TFA on K-12 student academic outcomes. Studies also had to use a research design which: 1. allowed valid causal inferences about TFA's effects, 2. targeted participants K-12 students taught by TFA corps members or TFA alumni in the USA, 3. compared TFA corps members to novice teachers, or compared TFA alumni with veteran teachers, and 4. reported at least one academic student outcome in math, ELA, or science domains.A total of 919 citations were retrieved on TFA, of which 24 studies were eligible for review. However, when the research design and study quality along with types of TFA corps members and non-TFA teachers compared were reviewed, the evidence base for estimating the effects of TFA on student academic outcomes was reduced to just four studies.There is no significant effect on reading from teaching by TFA corps members in their first or second year of teaching elementary-grade students (PreK - grade 5) compared to non-TFA teachers who are also in their first or second year of teaching elementary-grade students. There is a small positive effect for early elementary-grade students (PreK to grade 2) in reading but not in math.However, given the small evidence base, these findings should be treated with caution.What do the findings of this review mean?: TFA is the most evaluated program of its kind. Multiple quasi-experimental and experimental studies have been conducted on its effectiveness in improving student outcomes. However, this systematic review found that only a small number of these studies (1) met the evidence review standards and (2) compared the same type of TFA corps members and non-TFA teachers. So it is not possible to draw firm policy conclusions.Future research can contribute to this evidence base by designing, implementing, and reporting experiments and quasi-experiments to meet objective extant evidence standards and by comparing the same types of TFA and non-TFA teachers so that effect sizes can be included in a future systematic review and meta-analysis.How up-to-date is this review?: The review authors searched for studies published up to January 2015. This Campbell systematic review was published in June 2018.

Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries.

BACKGROUND: Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs' perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. METHODS: A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. RESULTS: A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. CONCLUSIONS: Research ethics committees identified a clear need for ethics guidelines for CRTs and education about distinct ethical issues in CRTs. There is disagreement among committees, even within the same countries, with respect to key questions in the ethics review of CRTs. This disagreement reflects variability of opinion and practices pointing toward possible gaps in knowledge, and supports the need for explicit guidelines for the ethical conduct and review of CRTs.

Survey of consent practices in cluster randomized trials: improvements are needed in ethical conduct and reporting.

BACKGROUND: Informed consent procedures in cluster randomized trials (CRTs) are considerably more complicated than in individually randomized trials. In a CRT, the units of randomization, intervention, and observation may differ in a single trial; there can be multiple levels of participants (individual and cluster level); consent may be required separately for intervention and data collection; and there may be practical constraints to seeking informed consent, for example, due to cluster-level interventions or the sheer size of clusters. PURPOSE: We aimed to document consent practices at individual and cluster levels, assess the adequacy of reporting consent in trial publications, and assess associations with two trial characteristics that may influence consent requirements in CRTs: presence or absence of study interventions and presence or absence of data collection procedures at individual and cluster levels. METHODS: We reviewed a random sample of 300 CRTs published during 2000-2008. We sent survey questionnaires to 285 unique authors of these trials to gather detailed information about consent procedures used in each trial. RESULTS: In all, 182 authors (64%) responded. Overall, 93% (95% confidence interval (CI): 88.8%-96.6%) indicated that participant consent had been sought for some aspects of the study. Consent was less frequently sought for a study intervention (70% of respondents) than for data collection (88%). More than half of the respondents (52%) indicated that consent had been sought at both cluster and individual levels. There was strong evidence for under-reporting of consent in trial publications: only 63% of all trial publications reported that informed consent had been sought for some aspect of the study. The odds ratios (ORs) summarizing the association of the two trial characteristics with cluster-level participant consent were weak (OR = 1.17, p = 0.70 for presence of cluster-level study intervention and OR = 1.54, p = 0.29 for data collection); on the other hand, the ORs summarizing the associations with individual-level consent were strong (OR = 6.2, p < 0.0001 for presence of individual-level intervention and OR = 14.7, p < 0.0001 for data collection). LIMITATIONS: In all, 36% of authors did not respond to the survey; to the extent that consent practices in their trials were different than in respondents' trials, our results may be biased. CONCLUSIONS: There is a need for improvements in research practices in CRTs as well as their reporting. There may be a lack of clarity about consent requirements at the cluster level in particular. With the publication of the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, researchers and research ethics committees now have access to comprehensive ethics guidelines specific to CRTs.

Henry W. Riecken Jr. (1917-2012).

Presents an obituary for Henry (Hank) W. Riecken Jr. In 1950, Riecken received his doctorate from Harvard University, having studied in the Department of Social Relations, which enjoyed a well-known relationship with the Department of Psychology. A thought leader, and a follower and booster of interesting thoughts (more prescience), Riecken was the first director of the National Science Foundation's (NSF's) Office of Social Sciences (later called a division) in 1959. As vice president and then president of the Social Science Research Council (SSRC) from 1966 to 1971, Hank led the development of the first state-of-the-art monograph on randomized controlled trials in the United States. Riecken was a member of the first Director's Advisory Committee at the National Institutes of Health. He became a member of the National Academy of Sciences' Board on Medicine in 1969 (one of two social scientists) and, as a founding member, assisted in the challenging effort to create the Institute of Medicine (IOM) in 1971. Hank is survived by his children Gilson, Susan, and Anne. He talked about them often, gently, and proudly and clearly loved them. The current Riecken Foundation, whose mission aims at substantial enhancements to libraries in Guatemala, is a testimony to Riecken's beneficence and to the intellectually generous spirit of him and his family.

Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

BACKGROUND: Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. PURPOSE: We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. METHODS: An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. RESULTS: The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or strongly agreed that there is a need to develop ethics guidelines for CRTs, and (70%; 95% CI: 63%-77%) that ethics committees could be better informed about distinct ethical issues surrounding CRTs. LIMITATIONS: Thirty-six percent of authors did not respond to the survey. Due to the absence of comparable results from a representative sample of authors of individually randomized trials, it is unclear to what extent the reported challenges result from the CRT design. CONCLUSIONS: CRT investigators are experiencing challenges in the research ethics review of their trials, including excessive delays, variability in process and outcome, and imposed requirements that can have negative consequences for study conduct. Investigators identified a clear need for ethics guidelines for CRTs and education of research ethics committees about distinct ethical issues in CRTs.

Researchers' perceptions of ethical challenges in cluster randomized trials: a qualitative analysis.

BACKGROUND: Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs. METHODS: Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers. RESULTS: Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees. CONCLUSIONS: Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.

Reporting of patient consent in healthcare cluster randomised trials is associated with the type of study interventions and publication characteristics.

OBJECTIVE: Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. STUDY DESIGN: Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication. RESULTS: 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. CONCLUSIONS: Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs.

What is the role and authority of gatekeepers in cluster randomized trials in health research?

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? 'Gatekeepers' are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster randomization, cluster-level interventions, and cluster size. In this paper, we call for a more restrictive understanding of the role and authority of gatekeepers.Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers. We considered that consent to randomization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data-collection procedures have started. Further, when cluster-level interventions or cluster size means that obtaining informed consent is not possible, a waiver of consent may be appropriate. In this paper, we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited. Generally, gatekeepers do not have the authority to provide proxy consent for cluster members. When a municipality or other community has a legitimate political authority that is empowered to make such decisions, cluster permission may be appropriate; however, gatekeepers may usefully protect cluster interests in other ways. Cluster consultation may ensure that the CRT addresses local health needs, and is conducted in accord with local values and customs. Gatekeepers may also play an important role in protecting the interests of organizations, such as hospitals, nursing homes, general practices, and schools. In these settings, permission to access the organization relies on resource implications and adherence to institutional policies.

When is informed consent required in cluster randomized trials in health research?

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?We set out a framework based on the moral foundations of informed consent and international regulatory provisions to address each of these questions. First, when informed consent is not possible, a study may proceed if a research ethics committee is satisfied that conditions for a waiver of consent are satisfied. Second, informed consent to randomization may not be required if it is not possible to approach subjects at the time of randomization. Third, when potential subjects are approached after cluster randomization, they must be provided with a detailed description of the interventions in the trial arm to which their cluster has been randomized; detailed information on interventions in other trial arms need not be provided. Fourth, while passive consent may serve a variety of practical ends, it is not a substitute for valid informed consent. Fifth, while health professionals may have a moral obligation to participate as subjects in research, this does not diminish the necessity of informed consent to study participation.

Who is the research subject in cluster randomized trials in health research?

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently.We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1) they are directly intervened upon by investigators; (2) they interact with investigators; (3) they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4) their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

Does clinical equipoise apply to cluster randomized trials in health research?

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act?In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial. Finally, clinical equipoise provides research ethics committees with formal and procedural guidelines that form an important part of the assessment of the benefits and harms of CRTs in health research.

Inadequate reporting of research ethics review and informed consent in cluster randomised trials: review of random sample of published trials.

OBJECTIVES: To investigate the extent to which authors of cluster randomised trials adhered to two basic requirements of the World Medical Association's Declaration of Helsinki and the International Committee of Medical Journal Editors' uniform requirements for manuscripts (namely, reporting of research ethics review and informed consent), to determine whether the adequacy of reporting has improved over time, and to identify characteristics of cluster randomised trials associated with reporting of ethics practices. DESIGN: Review of a random sample of published cluster randomised trials from an electronic search in Medline. SETTING: Cluster randomised trials in health research published in English language journals from 2000 to 2008. Study sample 300 cluster randomised trials published in 150 journals. RESULTS: 77 (26%, 95% confidence interval 21% to 31%) trials failed to report ethics review. The proportion reporting ethics review increased significantly over time (P<0.001). Trials with data collection interventions at the individual level were more likely to report ethics review than were trials that used routine data sources only (79% (n=151) v 55% (23); P=0.008). Trials that accounted for clustering in the design and analysis were more likely to report ethics review. The median impact factor of the journal of publication was higher for trials that reported ethics review (3.4 v 2.3; P<0.001). 93 (31%, 26% to 36%) trials failed to report consent. Reporting of consent increased significantly over time (P<0.001). Trials with interventions targeting participants at the individual level were more likely to report consent than were trials with interventions targeting the cluster level (87% (90) v 48% (41); P<0.001). Trials with data collection interventions at the individual level were more likely to report consent than were those that used routine data sources only (78% (146) v 29% (11); P<0.001). CONCLUSIONS: Reporting of research ethics protections in cluster randomised trials is inadequate. In addition to research ethics approval, authors should report whether informed consent was sought, from whom consent was sought, and what consent was for.

Replication in prevention science.

Replication research is essential for the advancement of any scientific field. In this paper, we argue that prevention science will be better positioned to help improve public health if (a) more replications are conducted; (b) those replications are systematic, thoughtful, and conducted with full knowledge of the trials that have preceded them; and (c) state-of-the art techniques are used to summarize the body of evidence on the effects of the interventions. Under real-world demands it is often not feasible to wait for multiple replications to accumulate before making decisions about intervention adoption. To help individuals and agencies make better decisions about intervention utility, we outline strategies that can be used to help understand the likely direction, size, and range of intervention effects as suggested by the current knowledge base. We also suggest structural changes that could increase the amount and quality of replication research, such as the provision of incentives and a more vigorous pursuit of prospective research registers. Finally, we discuss methods for integrating replications into the roll-out of a program and suggest that strong partnerships with local decision makers are a key component of success in replication research. Our hope is that this paper can highlight the importance of replication and stimulate more discussion of the important elements of the replication process. We are confident that, armed with more and better replications and state-of-the-art review methods, prevention science will be in a better position to positively impact public health.

Ethical issues posed by cluster randomized trials in health research.

The cluster randomized trial (CRT) is used increasingly in knowledge translation research, quality improvement research, community based intervention studies, public health research, and research in developing countries. However, cluster trials raise difficult ethical issues that challenge researchers, research ethics committees, regulators, and sponsors as they seek to fulfill responsibly their respective roles. Our project will provide a systematic analysis of the ethics of cluster trials. Here we have outlined a series of six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation: 1. Who is a research subject? 2. From whom, how, and when must informed consent be obtained? 3. Does clinical equipoise apply to CRTs? 4. How do we determine if the benefits outweigh the risks of CRTs? 5. How ought vulnerable groups be protected in CRTs? 6. Who are gatekeepers and what are their responsibilities? Subsequent papers in this series will address each of these areas, clarifying the ethical issues at stake and, where possible, arguing for a preferred solution. Our hope is that these papers will serve as the basis for the creation of international ethical guidelines for the design and conduct of cluster randomized trials.

Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study.

BACKGROUND: Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities--rather than individual themselves--are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1) identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2) understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK); (3) elicit the views and experiences of trial participants and cluster representatives; (4) develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5) disseminate the guidelines to researchers, research ethics boards (REBs), journal editors, and research funders. METHODS: We will use a mixed-methods (qualitative and quantitative) approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An Expert Panel of researchers, ethicists, health lawyers, consumer advocates, REB members, and representatives from low-middle income countries will be appointed. A consensus conference will be convened and draft guidelines will be generated by the Panel; an e-consultation phase will then be launched to invite comments from the broader community of researchers, policy-makers, and the public before a final set of guidelines is generated by the Panel and widely disseminated by the research team.

Associations between the Youth/Adolescent Questionnaire, the Youth/Adolescent Activity Questionnaire, and body mass index z score in low-income inner-city fourth through sixth grade children.

BACKGROUND: Diet and physical activity are important factors in the etiology, prevention, and treatment of chronic diseases such as obesity and its associated comorbidities. Accurate measures of diet and activity are critical in understanding how these lifestyle and behavioral factors covary to affect health status. OBJECTIVE: The purpose of this study was to investigate the relation between body mass index (BMI) z score and self-report measures of diet and activity, the Youth/Adolescent Questionnaire (YAQ) and the Youth/Adolescent Activity Questionnaire (YAAQ), respectively. DESIGN: Participants were 1092 students in grades 4 through 6 from 10 schools in a US city in the middle Atlantic region with >or=50% of students eligible for free or reduced-price meals. Students were assessed at baseline and again after 2 y. The relation between self-reported energy intake (YAQ) and activity (physical and sedentary) (YAAQ) and BMI z score was explored from both a cross-sectional and longitudinal perspective. RESULTS: The YAQ (energy intake) and YAAQ (physical and sedentary activity) did not relate to BMI z score in the expected directions from either a cross-sectional or longitudinal perspective. CONCLUSION: In this large, racially diverse sample, the YAQ and the YAAQ were not significantly associated with BMI z score or changes in BMI z score.

From randomized controlled trials to evidence grading schemes: current state of evidence-based practice in social sciences.

With the advance of web search and navigation technology, enormous amount of information, non-information, and misinformation may be obtained in milliseconds in response to questions about 'what works' in social sciences. Today, policy makers in non-medical public service arenas are under increasing pressure to make sound decisions based on scientific evidence. Some of these decisions are a matter of legal requirement. This paper shows how such movements are closely aligned with the evolution of organizations that develop and apply evidence standards and evidence grading schemes within the social science communities. The current state of evidence-based practice in social sciences is examined by reviewing the latest development of randomized trials and evidence grading schemes in the fields of education, criminal justice, and social welfare. Studies conducted under the auspices of the Campbell Collaboration and What Works Clearinghouse are used to illustrate ingredients of evidence grading schemes, graphic display of results of systematic reviews, and discrepancies of evidence derived from randomized trials and non-experimental trials. Furthermore, it is argued that the use of evidence on 'what works' depends on the potential users' awareness, understanding of the evidence, as well as their capacity and willingness to use it. Awareness and understanding depends on the world wide web and its augmentations, while capacity and willingness depends more on incentives to use good evidence and on political and ethical values. Implications for the future development of evidence grading organizations are discussed.

Standards of evidence: criteria for efficacy, effectiveness and dissemination.

Ever increasing demands for accountability, together with the proliferation of lists of evidence-based prevention programs and policies, led the Society for Prevention Research to charge a committee with establishing standards for identifying effective prevention programs and policies. Recognizing that interventions that are effective and ready for dissemination are a subset of effective programs and policies, and that effective programs and policies are a subset of efficacious interventions, SPR's Standards Committee developed overlapping sets of standards. We designed these Standards to assist practitioners, policy makers, and administrators to determine which interventions are efficacious, which are effective, and which are ready for dissemination. Under these Standards, an efficacious intervention will have been tested in at least two rigorous trials that (1) involved defined samples from defined populations, (2) used psychometrically sound measures and data collection procedures; (3) analyzed their data with rigorous statistical approaches; (4) showed consistent positive effects (without serious iatrogenic effects); and (5) reported at least one significant long-term follow-up. An effective intervention under these Standards will not only meet all standards for efficacious interventions, but also will have (1) manuals, appropriate training, and technical support available to allow third parties to adopt and implement the intervention; (2) been evaluated under real-world conditions in studies that included sound measurement of the level of implementation and engagement of the target audience (in both the intervention and control conditions); (3) indicated the practical importance of intervention outcome effects; and (4) clearly demonstrated to whom intervention findings can be generalized. An intervention recognized as ready for broad dissemination under these Standards will not only meet all standards for efficacious and effective interventions, but will also provide (1) evidence of the ability to "go to scale"; (2) clear cost information; and (3) monitoring and evaluation tools so that adopting agencies can monitor or evaluate how well the intervention works in their settings. Finally, the Standards Committee identified possible standards desirable for current and future areas of prevention science as the field develops. If successful, these Standards will inform efforts in the field to find prevention programs and policies that are of proven efficacy, effectiveness, or readiness for adoption and will guide prevention scientists as they seek to discover, research, and bring to the field new prevention programs and policies.

Quality of evidence: usefulness in measuring the quality of health care.

BACKGROUND: In 1998, the Committee on Health Care Quality in America was created and given the charge of devising a strategy to achieve substantial improvement in the quality of health care for all Americans. One strategy to move the quality agenda forward is the use of evidence by both providers of health care and consumers of health care. One feature of this agenda, evidence-based practice, refers to a hierarchy of evidence ranging from individual randomized, controlled trials to expert opinion. OBJECTIVES: The purposes of this article are to describe the evidence base in nursing, discuss the quality and strength of nursing's evidence, illustrate the application of the Quality Health Outcomes Model, and present recommendations for practice, research, and policy to increase nursing's contribution to quality health care. RESULTS AND RECOMMENDATIONS: Nurses everywhere must use innovative solutions to operationalize the "evidence" in evidence-based nursing. The Quality Health Outcomes Model (QHOM) provides a useful way of advancing research and evidence about the quality of health care in America. In concert with the conceptual framework for the National Health Care Quality Report, the QHOM provides a map for identifying evidence gaps and research questions arising from the model and conceptual framework, as well as evidence synthesis (integrating methodologic quality) driven by theoretical understanding.