Publishing the findings of clinical research.

Current regulations and practice may not prevent a sponsor of clinical research from delaying or preventing the dissemination of findings that do not support his or her commercial, professional, or managerial interests. Pharmaceutical trials are particularly subject to this concern, but the issue of non-publication has a wider significance. Patients participate in research on the understanding that it will be of public benefit. To be fair to these patients we must confirm that data will be analysed without bias and that findings will be regarded as being in the public domain and hence available to interested reviewers even if the results do not justify publication. Clinical investigators and ethics committees have the power and the duty to enforce this outcome.     

Implementing the ten steps to successful breastfeeding in multiple hospitals serving low-wealth patients in the US: innovative research design and baseline findings

Background

The Ten Steps to Successful Breastfeeding are maternity practices proven to support successful achievement of exclusive breastfeeding. They also are the basis for the WHO/UNICEF Baby-Friendly Hospital Initiative (BFHI). This study explores implementation of these steps in hospitals that serve predominantly low wealth populations.

Methods

A quasi-experimental design with mixed methods for data collection and analysis was included within an intervention project. We compared the impact of a modified Ten Steps implementation approach to a control group. The intervention was carried out in hospitals where: 1) BFHI designation was not necessarily under consideration, and 2) the majority of the patient population was low wealth, i.e., eligible for Medicaid. Hospitals in the research aspect of this project were systematically assigned to one of two groups: Initial Intervention or Initial Control/Later Intervention. This paper includes analyses from the baseline data collection, which consisted of an eSurvey (i.e., Carolina B-KAP), Maternity Practices in Infant Nutrition and Care survey tool (mPINC), the BFHI Self-Appraisal, key informant interviews, breastfeeding data, and formatted feedback discussion.

Results

Comparability was ensured by statistical and non-parametric tests of baseline characteristics of the two groups. Additional findings of interest included: 1) a universal lack of consistent breastfeeding records and statistics for regular monitoring/review, 2) widespread misinterpretation of associated terminology, 3) health care providers’ reported practices not necessarily reflective of their knowledge and attitudes, and 4) specific steps were found to be associated with hospital breastfeeding rates. A comprehensive set of facilitators and obstacles to initiation of the Ten Steps emerged, and hospital-specific practice change challenges were identified.

Discussion

This is one of the first studies to examine introduction of the Ten Steps in multiple hospitals with a control group and in hospitals that were not necessarily interested in BFHI designation, where the population served is predominantly low wealth, and with the use of a mixed methods approach. Limitations including numbers of hospitals and inability to adhere to all elements of the design are discussed.

Conclusions

For improvements in quality of care for breastfeeding dyads, innovative and site-specific intervention modification must be considered.

     

Why most published research findings are false

There is increasing concern that most current published research findings are false. The probability that a research claim is true may depend on study power and bias, the number of other studies on the same question, and, importantly, the ratio of true to no relationships among the relationships probed in each scientific field. In this framework, a research finding is less likely to be true when the studies conducted in a field are smaller; when effect sizes are smaller; when there is a greater number and lesser preselection of tested relationships; where there is greater flexibility in designs, definitions, outcomes, and analytical modes; when there is greater financial and other interest and prejudice; and when more teams are involved in a scientific field in chase of statistical significance. Simulations show that for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias. In this essay, I discuss the implications of these problems for the conduct and interpretation of research.     

Implementing community-based provider participation in research: an empirical study

ABSTRACT: BACKGROUND: Since 2003, the United States National Institutes of Health (NIH) has sought to restructure the clinical research enterprise in the United States by promoting collaborative research partnerships between academically-based investigators and community-based physicians. By increasing community-based provider participation in research (CBPPR), the NIH seeks to advance the science of discovery by conducting research in clinical settings where most people get their care, and accelerate the translation of research results into everyday clinical practice. Although CBPPR is seen as a promising strategy for promoting the use of evidencebased clinical services in community practice settings, few empirical studies have examined the organizational factors that facilitate or hinder the implementation of CBPPR. The purpose of this study is to explore the organizational start-up and early implementation of CBPPR in community-based practice. METHODS: We used longitudinal, case study research methods and an organizational model of innovation implementation to theoretically guide our study. Our sample consisted of three community practice settings that recently joined the National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP) in the United States. Data were gathered through site visits, telephone interviews, and archival documents from January 2008 to May 2011. RESULTS: The organizational model for innovation implementation was useful in identifying and investigating the organizational factors influencing start-up and early implementation of CBPPR in CCOP organizations. In general, the three CCOP organizations varied in the extent to which they achieved consistency in CBPPR over time and across physicians. All three CCOP organizations demonstrated mixed levels of organizational readiness for change. Hospital management support and resource availability were limited across CCOP organizations early on, although they improved in one CCOP organization. As a result of weak IPPs, all three CCOPs created a weak implementation climate. Patient accrual became concentrated over time among those groups of physicians for whom CBPPR exhibited a strong innovation-values fit. Several external factors influenced innovation use, complicating and enriching our intra-organizational model of innovation implementation. CONCLUSION: Our results contribute to the limited body of research on the implementation of CBPPR. They inform policy discussions about increasing and sustaining community clinician involvement in clinical research and expand on theory about organizational determinants of implementation effectiveness.     

Implementing large-scale and long-term functional biodiversity research: The Biodiversity Exploratories

Functional biodiversity research explores drivers and functional consequences of biodiversity changes. Land use change is a major driver of changes of biodiversity and of biogeochemical and biological ecosystem processes and services. However, land use effects on genetic and species diversity are well documented only for a few taxa and trophic networks. We hardly know how different components of biodiversity and their responses to land use change are interrelated and very little about the simultaneous, and interacting, effects of land use on multiple ecosystem processes and services. Moreover, we do not know to what extent land use effects on ecosystem processes and services are mediated by biodiversity change. Thus, overall goals are on the one hand to understand the effects of land use on biodiversity, and on the other to understand the modifying role of biodiversity change for land-use effects on ecosystem processes, including biogeochemical cycles. To comprehensively address these important questions, we recently established a new large-scale and long-term project for functional biodiversity, the Biodiversity Exploratories (www.biodiversity-exploratories.de). They comprise a hierarchical set of standardized field plots in three different regions of Germany covering manifold management types and intensities in grasslands and forests. They serve as a joint research platform for currently 40 projects involving over 300 people studying various aspects of the relationships between land use, biodiversity and ecosystem processes through monitoring, comparative observation and experiments. We introduce guiding questions, concept and design of the Biodiversity Exploratories – including main aspects of selection and implementation of field plots and project structure – and we discuss the significance of this approach for further functional biodiversity research. This includes the crucial relevance of a common study design encompassing variation in both drivers and outcomes of biodiversity change and ecosystem processes, the interdisciplinary integration of biodiversity and ecosystem researchers, the training of a new generation of integrative biodiversity researchers, and the stimulation of functional biodiversity research in real landscape contexts, in Germany and elsewhere.     

Meta-analysis: synthesizing research findings in ecology and evolution

The growing number of empirical studies performed in ecology and evolution creates a need for quantitative summaries of research domains to generate higher-order conclusions about general trends and patterns. Recent developments In meta-analysis (the area of statistics that is designed for summarizing and analyzing multiple independent studies) have opened up new and exciting possibilities. Unlike more traditional qualitative and narrative reviews, meta-analysis allows powerful quantitative analyses of the magnitude of effects and has a high degree of objectivity because it is based on a standardized set of statistical procedures. The first pioneering applications in ecology and evolution demonstrate that meta-analysis is both tractable and powerful.     

HIV research in Australia: linking basic research findings with clinical and public health outcomes

H9-T-cells do not support the replication of mutant HIV-1 encoding Env protein lacking its long cytoplasmic C-terminal domain (Env-CT). Here we describe the generation of a H9-T-cell population constitutively expressing the HIV-1 Env-CT protein domain anchored in the cellular membrane by it homologous membrane-spanning domain (TMD). We confirmed that the Env-TMD-CT protein was associated with cellular membranes, that its expression did not have any obvious cytotoxic effects on the cells and that it did not affect wild-type HIV-1 replication. However, as measured in both a single-round assay as well as in spreading infections, replication competence of mutant pNL-Tr712, lacking the Env-CT, was not restored in this H9 T-cell population. This means that the Env-CT per se cannot transcomplement the replication block of HIV-1 virions encoding C-terminally truncated Env proteins and suggests that the Env-CT likely exerts its function only in the context of the complete Env protein.