Designing a research infrastructure on dietary intake and its determinants

Research on dietary intake and its determinants is crucial for an adequate response to the current epidemic of diet‐related non‐communicable chronic diseases. In order to respond to this challenge, the RICHFIELDS project was tasked with designing a research infrastructure (RI) that connects data on dietary intake of consumers in Europe, and its determinants, collected using apps and wearable sensors, from behavioural laboratories and experimental facilities and from other RIs. The main output of the project, an RI design, describes interfaces (portals) to collect data, a meta‐database and a data‐model to enable data linkage and sharing. The RICHFIELDS project comprises three phases, each consisting of three work packages, and an overarching methodological support work package. Phase 1 focused on data generated by consumers (e.g. collected by apps and sensors) relating to the purchase, preparation and consumption of food. Phase 2 focused on data generated by organisations such as businesses (e.g. retail data), government (e.g. procurement data) and experimental research facilities (e.g. virtual supermarkets). Phases 1 and 2 provided Phase 3 with insights on data types and design requirements, including the business models, data integration and management systems and governance and ethics. The final design will be used in the coming years to build an RI for the scientific research community, policy makers and businesses in Europe. The RI will boost interdisciplinary multi‐stakeholder research through harmonisation and integration of data on food behaviour.     

Policy implications intervention research: Research on the social context for intervention

Intervention research is of significance because the failure or success of particular interventions may have influence on policy and practice. Poorly designed interventions may impede progress in health and safety. Frequently, interventions are based on scientific/technical definitions of occupational health and safety problems but involve intrusion into complex sociotechnical work environments. Intervention research must be built on a solid foundation of social science research. An example of research useful to health and safety intervention is the Gray Institute study of management practices in the chemical industry that was commissioned by OSHA a few years ago. It focused on safety management in chemical manufacturing firms and their contractors, including a survey of managers and contractors and nine intensive case studies of particular plants. The study describes safety management practices in the best firms in the industry. Such research can provide the groundwork for effective safety interventions in the industry, including training and training requirements, experimentation with redefined managerial responsibilities, regulation of contractors, and others. It also suggests the kinds of useful data that might be collected by NIOSH in the normal course of health and safety studies. Finally, it suggests that the interdisciplinary teams currently investigating occupational health and safety should be expanded to include social scientists. © 1996 Wiley-Liss, Inc.     

Reporting of occupational and environmental research: use and misuse of statistical and epidemiological methods

OBJECTIVES—To report some of the most serious omissions and errors which may occur in papers submitted to Occupational and Environmental Medicine, and to give guidelines on the essential components that should be included in papers reporting results from studies of occupational and environmental health.
METHODS—Since 1994 Occupational and Environmental Medicine has used a panel of medical statisticians to review submitted papers which have a substantial statistical content. Although some studies may have genuine errors in their design, execution, and analysis, many of the problems identified during the reviewing process are due to inadequate and incomplete reporting of essential aspects of a study. This paper outlines some of the most important errors and omissions that may occur. Observational studies are often the preferred choice of design in occupational and environmental medicine. Some of the issues relating to design, execution, and analysis which should be considered when reporting three of the most common observational study designs, cross sectional, case-control, and cohort are described. An illustration of good reporting practice is given for each. Various mathematical modelling techniques are often used in the analysis of these studies, the reporting of which causes a major problem to some authors. Suggestions for the presentation of results from modelling are made.
CONCLUSIONS—There is increasing interest in the development and application of formal "good epidemiology practices". These not only consider issues of data quality, study design, and study conduct, but through their structured approach to the documentation of the study procedures, provide the potential for more rigorous reporting of the results in the scientific literature.


Keywords: research reporting; statistical methods; epidemiological methods     

Qualitative methods for intervention research

Intervention research takes place in field settings and requires understanding of social meanings and social processes. These are tasks for which qualitative research methods are well suited. The purpose of this paper is to provide a starting point for those who would like to learn more about the qualitative research methods used in disciplines where the study of social phenomena in naturalistic settings is common—particularly sociology, cultural anthropology, and human services program evaluation. The paper discusses some ways that qualitative and quantitative methodologies can usefully work together, outlines four key differences in the initial premises of quantitative and qualitative research approaches, briefly reviews some methodological techniques useful in gathering and analyzing qualitative data, and provides suggestions for further reading on various aspects of qualitative research. © 1996 Wiley-Liss, Inc.     

Intervention research: Science,skills, and strategies

Despite a rich history of etiological research, the field of occupational safety and health does not a have a rigorous history of research on what works and does not work to prevent and control occupational diseases and injuries. National and global transformations of economies and workplaces with enhanced competitiveness require more attention to options for interventions. A three-pronged approach to building a body of knowledge on intervention research in occupational health and safety is identified in this paper. The approach focuses on the science, skills, and strategies that can be useful in intervention research. Scientifically, researches can draw on constructs and techniques from epidemiology, evaluation practice, and clinical trials. Experimental and nonexperimental approaches have value for occupational studies. The skills needed represent a range of disciplines beyond those traditional of health and safety; social scientists, economists, and organizational theorists often need to be part of research teams. Strategic approaches involve more labor-management partnerships, prospective study designs, and the use of intermediate and surrogate indicators. The strategic challenge will be to conduct intervention research against a backdrop of overriding political and economic pressures. (This article is a US Government work and, as such, is in the public domain in the United States of America.) © 1996 Wiley-Liss, Inc.     

Photo methods for qualitative research in nursing: an ontological and epistemological perspective

Abstract  The use of photo research methods is influenced by underlying ontological and epistemological assumptions. Variant assumptions about reality and knowledge converge to conceive a relationship between the knower and what can be known. These assumptions provide the rationale for decided ways of engaging participants in the process of scientific inquiry. In this paper, we examine how perspectives of realism and relativism may shape epistemological understandings and influence type and use of photo methods in qualitative research. Based on deliberations about underlying ontological and epistemological assumptions and related strengths and challenges of photo methods, we assert that photo methods contribute to the development of knowledge that both matters to participants and informs nursing practice.     

加强临床医学研究管理促进临床研究良性发展

随着我国医学的发展,临床医学研究项目逐渐增多,管理的相关问题也逐渐显现.为了规范临床医学研究管理,使研究的结果真实可靠,研究结果真正受益于广大患者,中山大学孙逸仙纪念医院通过规范申请程序;发挥学术委员会及伦理委员会的作用;加强项目的过程管理;对研究者加强培训等几个方面严格临床研究项目的管理,促进了医院临床医学研究的良性发展.     

卫生政策与体系研究:界定范围，辨别方法

从中低收入国家到高收入国家,卫生服务和体系研究术语的使用混乱状况普遍存在。在卫生服务研究文献和近期卫生政策与体系研究成果的基础上,本文将讨论卫生政策与体系研究方法。本文初稿在卫生政策与体系研究联盟的会议上讨论过。该联盟成立于1998年,旨在促进和支持中低收入国家的卫生政策与体系研究。本文评价卫生政策与体系研究方法,建议优先发展策略,并指出了卫生政策与体系研究所面临的挑战。     

From health research to social research: privacy, methods, approaches

Information-rich environments in Canada, Australia, and the United Kingdom have been built using record linkage techniques with population-based health insurance systems and longitudinal administrative data. This paper discusses the issues in extending population-based administrative data from health to additional topics more generally connected with well being. The scope of work associated with a multi-faceted American survey, the Panel Study in Income Dynamics (PSID), is compared with that of the administrative data in Manitoba, Canada. Both the PSID and the Manitoba database go back over 30 years, include families, and have good information on residential location. The PSID has emphasized research design to maximize the opportunities associated with expensive primary data collection. Information-rich environments such as that in Manitoba depend on registries and record linkage to increase the range of variables available for analysis. Using new databases on education and income assistance to provide information on the whole Manitoba population has involved linking files while preserving privacy, scaling educational achievement, assessing exposure to a given neighborhood, and measuring family circumstances. Questions being studied concern the role of the socioeconomic gradient and infant health in child development, the comparative influence of family and neighborhood in later well being, and the long-term effects of poverty reduction. Issues of organization of research, gaps in the data, and productivity are discussed.     

Patient‐initiated recruitment for clinical research: Evaluation of an outpatient letter research statement

Background

UK Hospital Trusts are charged with increasing patients’ research awareness and willingness to take part in research. This includes implementing strategies to encourage patient‐initiated enquiries about participation.

Objectives

To evaluate the impact of a research statement inserted in outpatient letters in one clinical service, and to derive suggestions on potential steps towards increasing patient‐initiated recruitment.

Setting

A medical outpatient clinic of a research‐active hospital trust, serving an inner‐city multi‐ethnic population across two boroughs.

Methods

Pre‐intervention and post‐intervention questionnaires were administered face‐to‐face to new patients. Questionnaires included closed questions and one open comments section. Data were analysed for frequencies, with thematic coding of open‐ended responses.

Results

The response rates were 87% for the pre‐intervention survey and 92% for the post‐intervention survey. In the post‐intervention survey, 85% of patients did not notice the research statement in the letter. More than half found the statement “a little unclear,” whilst one‐third considered it “clear.” Three‐quarters of respondents perceived the statement to be “a little helpful.” Only one person enquired about participating in clinical research having read the statement in the outpatient letter.

Conclusion

The analysis suggests that simple, single‐solution approaches such as including research statements in outpatient letters are unlikely to be sufficient to significantly facilitate patient‐initiated recruitment. Recruitment efforts need to take into consideration the diversity of patient constituencies including the reasons they seek health care, and how patients can meaningfully access information (research literacy).     

Envisioning a learning health care system: the electronic primary care research network, a case study

PURPOSE

The learning health care system refers to the cycle of turning health care data into knowledge, translating that knowledge into practice, and creating new data by means of advanced information technology. The electronic Primary Care Research Network (ePCRN) was a project, funded by the US National Institutes of Health, with the aim to facilitate clinical research using primary care electronic health records (EHRs).

METHODS

We identified the requirements necessary to deliver clinical studies via a distributed electronic network linked to EHRs. After we explored a variety of informatics solutions, we constructed a functional prototype of the software. We then explored the barriers to adoption of the prototype software within US practice-based research networks.

RESULTS

We developed a system to assist in the identification of eligible cohorts from EHR data. To preserve privacy, counts and flagging were performed remotely, and no data were transferred out of the EHR. A lack of batch export facilities from EHR systems and ambiguities in the coding of clinical data, such as blood pressure, have so far prevented a full-scale deployment. We created an international consortium and a model for sharing further ePCRN development across a variety of ongoing projects in the United States and Europe.

CONCLUSIONS

A means of accessing health care data for research is not sufficient in itself to deliver a learning health care system. EHR systems need to use sophisticated tools to capture and preserve rich clinical context in coded data, and business models need to be developed that incentivize all stakeholders from clinicians to vendors to participate in the system.     

From efficacy to effectiveness: case studies in unemployment research

There have been few attempts to implement and disseminate programmes to address the psychological health impact of unemployment despite the burden of this problem upon public health and health services. One approach that has demonstrated efficacy in promoting both psychological health and employment for this group is based upon the principles of cognitive behavioural therapy (CBT). We have been involved in three interventions based upon CBT to improve the psychological health of people who are unemployed, delivered through existing service structures in Australia: employment support agencies, general practice and mental health services. In this paper, we examine our experiences in conducting research within these service organizations using a framework for collaboration between researchers and services based upon intersectoral action. While effective collaboration can facilitate the implementation of research within systems, poor collaboration can impact upon the integrity of research designs. In our experience, it was the capacity of service organizations to address the psychological health impact of unemployment in particular that had a significant effect upon adoption of the intervention. Service organizations did not have structures to support the rigorous evaluation of interventions nor did they have funding arrangements that facilitated effective collaboration on research to address psychological issues. The dissemination of evidence-based interventions like CBT to populations of people who are unemployed in Australia is hindered by the absence of an accessible and appropriate system through which to address the psychological health impact of unemployment.     

Comparative Effectiveness Research and Evidence-Based Health Policy: Experience from Four Countries

Context: The discussion about improving the efficiency, quality, and long-term sustainability of the U.S. health care system is increasingly focusing on the need to provide better evidence for decision making through comparative effectiveness research (CER). In recent years, several other countries have established agencies to evaluate health technologies and broader management strategies to inform health care policy decisions. This article reviews experiences from Britain, France, Australia, and Germany.
Methods: This article draws on the experience of senior technical and administrative staff in setting up and running the CER entities studied. Besides reviewing the agencies' websites, legal framework documents, and informal interviews with key stakeholders, this analysis was informed by a workshop bringing together U.S. and international experts.
Findings: This article builds a matrix of features identified from the international models studied that offer insights into near-term decisions about the location, design, and function of a U.S.-based CER entity. While each country has developed a CER capacity unique to its health system, elements such as the inclusiveness of relevant stakeholders, transparency in operation, independence of the central government and other interests, and adaptability to a changing environment are prerequisites for these entities' successful operation.
Conclusions: While the CER entities evolved separately and have different responsibilities, they have adopted a set of core structural, technical, and procedural principles, including mechanisms for engaging with stakeholders, governance and oversight arrangements, and explicit methodologies for analyzing evidence, to ensure a high-quality product that is relevant to their system.     

Comparative effectiveness research: from clinical information to economic incentives

Comparative effectiveness research has been promoted as a way to control health care costs, but there has been less discussion of the mechanisms through which new evidence actually will influence physician practice, patient preference, and manufacturer investment. Public and private insurers use conditional coverage, consumer cost sharing, provider contracting, and drug payment policies to manage and direct the flow of resources into the health care system. This paper examines how each of these approaches may be adapted to incorporate new evidence from comparative effectiveness research.     

Comparative effectiveness research in mental health: an advocate's perspective

Comparative effectiveness research holds great promise for improving the care of people with mental health conditions and disorders related to substance abuse. But inappropriate application of such research can threaten the quality of that care. We examine the controversy surrounding a large real-world trial of schizophrenia treatments and conclude that the initial presentation of results led to overly simplistic policy suggestions that had the potential to harm patients. Patient advocacy groups helped illuminate these consequences and helped stimulate further discussion and analysis. Researchers must engage stakeholders, especially patients, in all aspects of comparative effectiveness research and translate the findings into sound mental health policy and practice.     

Bayesian methods in cost–effectiveness studies: objectivity,computation and other relevant aspects

In a probabilistic sensitivity analysis (PSA) of a cost–effectiveness (CE) study, the unknown parameters are considered as random variables. A crucial question is what probabilistic distribution is suitable for synthesizing the available information (mainly data from clinical trials) about these parameters. In this context, the important role of Bayesian methodology has been recognized, where the parameters are of a random nature. We explore, in the context of CE analyses, how formal objective Bayesian methods can be implemented. We fully illustrate the methodology using two CE problems that frequently appear in the CE literature. The results are compared with those obtained with other popular approaches to PSA. We find that the discrepancies can be quite marked, specially when the number of patients enrolled in the simulated cohort under study is large. Finally, we describe in detail the numerical methods that need to be used to obtain the results. Copyright © 2009 John Wiley & Sons, Ltd.     

The science of sex research: Some methodological considerations

This paper represents a review of substantive theoretical, methodological, and statistical issues relevant to conducting research on human sexual behavior. Guidelines for maintaining rigor and precision in future investigations are also proposed. So as to be able to address issues that pervade all research on human sexual behavior, six topic areas are discussed: theory-related issues, issues involving research design, issues involving subject selection, measurement issues, data-analytic issues, and issues concerned with human-subject protection. The ultimate objective of this paper is to make suggestions aimed at improving the quality of research on human sexual behavior.Invited paper, Conference on Methodology in Sex Research, Washington, D.C., November 8–19, 1977. This investigation was supported in part by a Research Scientist Development Award (KO2-DA00017), Biomedical Research Support Grant from University of California, Los Angeles, and research grant DA1070 from the U.S. Public Health Service. The assistance of Bonnie Barron is gratefully acknowledged.