Good Research Practice Research Articles

The Researchers' View of Scientific Rigor-Survey on the Conduct and Reporting of In Vivo Research.

Reproducibility in animal research is alarmingly low, and a lack of scientific rigor has been proposed as a major cause. Systematic reviews found low reporting rates of measures against risks of bias (e.g., randomization, blinding), and a correlation between low reporting rates and overstated treatment effects. Reporting rates of measures against bias are thus used as a proxy measure for scientific rigor, and reporting guidelines (e.g., ARRIVE) have become a major weapon in the fight against risks of bias in animal research. Surprisingly, animal scientists have never been asked about their use of measures against risks of bias and how they report these in publications. Whether poor reporting reflects poor use of such measures, and whether reporting guidelines may effectively reduce risks of bias has therefore remained elusive. To address these questions, we asked in vivo researchers about their use and reporting of measures against risks of bias and examined how self-reports relate to reporting rates obtained through systematic reviews. An online survey was sent out to all registered in vivo researchers in Switzerland (N = 1891) and was complemented by personal interviews with five representative in vivo researchers to facilitate interpretation of the survey results. Return rate was 28% (N = 530), of which 302 participants (16%) returned fully completed questionnaires that were used for further analysis. According to the researchers’ self-report, they use measures against risks of bias to a much greater extent than suggested by reporting rates obtained through systematic reviews. However, the researchers’ self-reports are likely biased to some extent. Thus, although they claimed to be reporting measures against risks of bias at much lower rates than they claimed to be using these measures, the self-reported reporting rates were considerably higher than reporting rates found by systematic reviews. Furthermore, participants performed rather poorly when asked to choose effective over ineffective measures against six different biases. Our results further indicate that knowledge of the ARRIVE guidelines had a positive effect on scientific rigor. However, the ARRIVE guidelines were known by less than half of the participants (43.7%); and among those whose latest paper was published in a journal that had endorsed the ARRIVE guidelines, more than half (51%) had never heard of these guidelines. Our results suggest that whereas reporting rates may underestimate the true use of measures against risks of bias, self-reports may overestimate it. To a large extent, this discrepancy can be explained by the researchers’ ignorance and lack of knowledge of risks of bias and measures to prevent them. Our analysis thus adds significant new evidence to the assessment of research integrity in animal research. Our findings further question the confidence that the authorities have in scientific rigor, which is taken for granted in the harm-benefit analyses on which approval of animal experiments is based. Furthermore, they suggest that better education on scientific integrity and good research practice is needed. However, they also question reliance on reporting rates as indicators of scientific rigor and highlight a need for more reliable predictors.

Resisting Best-Practice in Australian Practice-Based Jazz Doctorates

Recent research on practice-based doctorates in Australia has revealed an institutional preference for ‘theorised’ research approaches aimed at situating studies of practice within established academic paradigms. In this article we examine how the aim of communicating with artistic peers steers the research design and the production of text-based artefacts for a group of practice-based doctoral students working on jazz topics (n = 11) away from theorised approaches and towards what is commonly referred to as a ‘commentary’ approach. This finding reveals the extent to which the values of an artistic community can influence the scope of what is discussed within practice-based doctorates and highlights the need for ongoing discussion related to how such values might best interface with what institutions view as best-practice research frameworks.

Methods to construct a step-by-step beginner's guide to decision analytic cost-effectiveness modeling.

BackgroundAlthough guidance on good research practice in health economic modeling is widely available, there is still a need for a simpler instructive resource which could guide a beginner modeler alongside modeling for the first time.AimTo develop a beginner’s guide to be used as a handheld guide contemporaneous to the model development process.MethodsA systematic review of best practice guidelines was used to construct a framework of steps undertaken during the model development process. Focused methods review supplemented this framework. Consensus was obtained among a group of model developers to review and finalize the content of the preliminary beginner’s guide. The final beginner’s guide was used to develop cost-effectiveness models.ResultsThirty-two best practice guidelines were data extracted, synthesized, and critically evaluated to identify steps for model development, which formed a framework for the beginner’s guide. Within five phases of model development, eight broad submethods were identified and 19 methodological reviews were conducted to develop the content of the draft beginner’s guide. Two rounds of consensus agreement were undertaken to reach agreement on the final beginner’s guide. To assess fitness for purpose (ease of use and completeness), models were developed independently and by the researcher using the beginner’s guide.ConclusionA combination of systematic review, methods reviews, consensus agreement, and validation was used to construct a step-by-step beginner’s guide for developing decision analytical cost-effectiveness models. The final beginner’s guide is a step-by-step resource to accompany the model development process from understanding the problem to be modeled, model conceptualization, model implementation, and model checking through to reporting of the model results.

Os desafios de dados de pesquisa abertos

A gestão, a disponibilização e a preservação dos dados de pesquisas são preocupações cada vez mais centrais para os pesquisadores, as instituições de pesquisas e também para as agências de fomento e revistas cientificas. Todos esses têm o objetivo de desenvolver boas práticas de pesquisa que permitam a verificação e a reutilização dos dados, a valorização dos trabalhos de construção de conjuntos de dados e o desenvolvimento de novas maneiras de pesquisar utilizando dados já produzidos. Este artigo apresenta as diferentes etapas do ciclo de vida dos dados e mostra as iniciativas internacionais e nacionais tomadas para desenvolver esse campo que tem grande interesse para a área da saúde.

A synthesis of the evidence on peer research with potentially vulnerable adults: how this relates to dementia.

There is limited literature around peer research in dementia. This study aims to identify the benefits, the risks and the practical challenges and to develop a model of good practice in peer research with people with dementia. We searched on PsycInfo, PubMed and Google Scholar for empirical investigations or discussion papers on peer research. Given the limited literature in the field of dementia, we included studies with groups who share similar demographics (older people), experience of stigma (mental health service users) and exclusion from research (people with learning disabilities). We applied no restrictions on language and publication date. We identified three themes: the potential benefits, the potential risks and the practical challenges of peer research. We developed a model of good practice. The European Working Group of People with Dementia reviewed our paper and added to our findings. We included seven papers. Potential benefits of peer research included enriched data and empowering people with dementia. Potential risks included power differentials between researchers and issues of representativeness. The practical issues for good practice included the training of peer researchers, defining involvement and roles, working with cognitive impairment and considering resource implications. The European Working Group of People with Dementia emphasised the importance of equality issues. Involving people with dementia in peer research can generate several benefits, including empowerment and opportunities for inclusion for the peer researchers and the research participants living with dementia, challenging academics' traditional views on research processes and gathering enhanced research data. There remains a need for further research on the impact of peer research in dementia studies. Copyright © 2016 John Wiley & Sons, Ltd.

Estimating Health-State Utility for Economic Models in Clinical Studies: An ISPOR Good Research Practices Task Force Report

Cost-utility models are increasingly used in many countries to establish whether the cost of a new intervention can be justified in terms of health benefits. Health-state utility (HSU) estimates (the preference for a given state of health on a cardinal scale where 0 represents dead and 1 represents full health) are typically among the most important and uncertain data inputs in cost-utility models. Clinical trials represent an important opportunity for the collection of health-utility data. However, trials designed primarily to evaluate efficacy and safety often present challenges to the optimal collection of HSU estimates for economic models. Careful planning is needed to determine which of the HSU estimates may be measured in planned trials; to establish the optimal methodology; and to plan any additional studies needed. This report aimed to provide a framework for researchers to plan the collection of health-utility data in clinical studies to provide high-quality HSU estimates for economic modeling. Recommendations are made for early planning of health-utility data collection within a research and development program; design of health-utility data collection during protocol development for a planned clinical trial; design of prospective and cross-sectional observational studies and alternative study types; and statistical analyses and reporting.

Feedback from research participants: are member checks useful in qualitative research?

ABSTRACTIt is often assumed that use of so-called “member checks” improves the credibility of qualitative research. Published literature mentioning member checks was reviewed to identify the purposes and procedures for seeking feedback from research participants as well as outcomes reported from member checks. Four themes reflecting underlying assumptions about the purposes of research that have implications for member checks were identified: theory generalisation, representation, participation, and change. Member checks are unlikely to be relevant to research focussed on theory development and generalisation. For other types of research, member checks might be justifiable, but there was little evidence that member checks improved research findings. Member checks can be useful for obtaining participant approval for using quotations or case studies and where anonymity cannot be guaranteed. In evaluation, stakeholder reviews of draft reports can be seen as good research practice. In participatory or collaborative research, ongoing contact might include member checks.

Perfectionism as a warning sign for postnatal mental health difficulties

There is a growing evidence base indicating that maladaptive perfectionism is a risk factor for later mental health difficulties, such as postnatal depression. Perfection is defined as a state where an individual determinedly pursues self-imposed, personally demanding standards, despite adverse consequences. The article gives an overview of the links between clinical perfectionism and perinatal mental health difficulties, drawing on current research and models of best practice. Front-line health professionals such as health visitors are well placed to identify perfectionism early by assessing personality traits and other risk factors for depression and anxiety, and work with women and their families to prevent the onset of later, more severe, presentations.

Nursing research ethics, guidance and application in practice.

Ethics is fundamental to good research practice and the protection of society. From a historical point of view, research ethics has had a chequered past and without due cognisance there is always the potential for research to do harm. Research ethics is fundamental to research practice, nurse education and the development of evidence. In conducting research, it is important to plan for and anticipate any potential or actual risks. To engage in research, researchers need to develop an understanding and knowledge of research ethics and carefully plan how to address ethics within their research. This article aims to enhance students' and novice researchers' research ethics understanding and its application to nursing research.

Sobre gestión de medios: elogio a la trascendencia

This article questions the structure of the relatively recent academic subfield known scientifically as media management. In doing so, it takes a critical look at what the authors conceptualize as CADI (Spanish acronym), which stands for four structural dimensions that modulate the “spirit” of its form: 1) field, 2) autonomy, 3) technical and practical domination and 4) identity. CADI, which usually is portrayed as a model of good research practice, is described in this article as a state of academic confort in which a series of rules, practices and habitus socialized by the media management community might actually obstruct and repress academic progress toward other intellectual alternatives and modes of discovery and scientific verification. For that reason, the author proposes the concept of “transcendent rupture” as a strategy to achieve individual and disciplinary emancipation from the structural ideological regime of the subfield through three versions: theoretical rupture, functional rupture and epistemological rupture. DOI: 10.5294/pacla.2016.19.3.8

Promotion of research integrity in Latin American institutions

Abstract Most Latin American Research Institutions do not have an establish system to detect and denounce research misconduct This article reflects on the need to establish high standards in research integrity and monitoring mechanisms in Latin American Research Institutions in order to have an accurate science and for transferring research results to public policies, health promotion and social progress. Based on the experience of developed countries, we propose the following mechanisms to promote research integrity: to promote a culture to enhance good research practices; to establish norms to maintain responsible conduct of research; to establish monitoring proceedings; and to establish mechanisms of support to affront demands of research misconduct.

Development of the Galaxy Chronic Obstructive Pulmonary Disease (COPD) Model Using Data from ECLIPSE: Internal Validation of a Linked-Equations Cohort Model.

The recent joint International Society for Pharmacoeconomics and Outcomes Research / Society for Medical Decision Making Modeling Good Research Practices Task Force emphasized the importance of conceptualizing and validating models. We report a new model of chronic obstructive pulmonary disease (COPD) (part of the Galaxy project) founded on a conceptual model, implemented using a novel linked-equation approach, and internally validated. An expert panel developed a conceptual model including causal relationships between disease attributes, progression, and final outcomes. Risk equations describing these relationships were estimated using data from the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study, with costs estimated from the TOwards a Revolution in COPD Health (TORCH) study. Implementation as a linked-equation model enabled direct estimation of health service costs and quality-adjusted life years (QALYs) for COPD patients over their lifetimes. Internal validation compared 3 years of predicted cohort experience with ECLIPSE results. At 3 years, the Galaxy COPD model predictions of annual exacerbation rate and annual decline in forced expiratory volume in 1 second fell within the ECLIPSE data confidence limits, although 3-year overall survival was outside the observed confidence limits. Projections of the risk equations over time permitted extrapolation to patient lifetimes. Averaging the predicted cost/QALY outcomes for the different patients within the ECLIPSE cohort gives an estimated lifetime cost of £25,214 (undiscounted)/£20,318 (discounted) and lifetime QALYs of 6.45 (undiscounted/5.24 [discounted]) per ECLIPSE patient. A new form of model for COPD was conceptualized, implemented, and internally validated, based on a series of linked equations using epidemiological data (ECLIPSE) and cost data (TORCH). This Galaxy model predicts COPD outcomes from treatment effects on disease attributes such as lung function, exacerbations, symptoms, or exercise capacity; further external validation is required.

Statistical Methods for the Analysis of Discrete Choice Experiments: A Report of the ISPOR Conjoint Analysis Good Research Practices Task Force

Conjoint analysis is a stated-preference survey method that can be used to elicit responses that reveal preferences, priorities, and the relative importance of individual features associated with health care interventions or services. Conjoint analysis methods, particularly discrete choice experiments (DCEs), have been increasingly used to quantify preferences of patients, caregivers, physicians, and other stakeholders. Recent consensus-based guidance on good research practices, including two recent task force reports from the International Society for Pharmacoeconomics and Outcomes Research, has aided in improving the quality of conjoint analyses and DCEs in outcomes research. Nevertheless, uncertainty regarding good research practices for the statistical analysis of data from DCEs persists. There are multiple methods for analyzing DCE data. Understanding the characteristics and appropriate use of different analysis methods is critical to conducting a well-designed DCE study. This report will assist researchers in evaluating and selecting among alternative approaches to conducting statistical analysis of DCE data. We first present a simplistic DCE example and a simple method for using the resulting data. We then present a pedagogical example of a DCE and one of the most common approaches to analyzing data from such a question format—conditional logit. We then describe some common alternative methods for analyzing these data and the strengths and weaknesses of each alternative. We present the ESTIMATE checklist, which includes a list of questions to consider when justifying the choice of analysis method, describing the analysis, and interpreting the results.

Towards a framework for creative online collaboration: A research on challenges and context

The OnCreate project was initiated by ten universities with expertise in collaborative work in online-based learning environments and explores the specific challenges of implementing university courses in creative disciplines in such an environment. The first research phase comprises a literature search on creativity and its contextual factors in online collaboration in an educational setting. From this research a first set of possible key challenges and contextual key factors has been selected and applied to categorize the results of interviews and surveys on current good practice in creative online collaboration among experienced online teachers from the partner universities. From the key findings we formulate hypotheses to guide future research towards a framework for creative online collaboration. At the same time, the results can serve as inspiration for the educational practice. Notable observations of the good practice research among the partner universities are that they realise innovative collaboration concepts usually on mashed-up environments of state-of-the-art web services rather than on the omnipresent learning management systems (such as Moodle or Blackboard). Also, they show a paradigm shift from teaching to coaching and promotion of an open peer-review culture among the students.

Value of Information in Asia: Concepts, Current Use, and Future Directions

Health technology assessment is a form of health policy research that provides policymakers with information relevant to decisions about policy alternatives. Findings from cost-effectiveness analysis (CEA) are one of the important aspects of health technology assessment. Nevertheless, the more advanced method of value of information (VOI), which is recommended by the International Society for Pharmacoeconomics and Outcomes Research and Society for Medical Decision Making Modeling Good Research Practices Task Force, has rarely been applied in CEA studies in Asia. The lack of VOI in Asian CEA studies may be due to limited understanding of VOI methods and what VOI can and cannot help policy decision makers accomplish. This concept article offers audiences a practical primer in understanding the calculation, presentation, and policy implications of VOI. In addition, it provides a rapid survey of health technology assessment guidelines and literature related to VOI in Asia and discusses the future directions of VOI use in Asia and its potential barriers. This article will enable health economists, outcomes researchers, and policymakers in Asia to better understand the importance of VOI analysis and its implications, leading to the appropriate use of VOI in Asia.

A Multi-Layered Approach to Botanical Authenticity Fosters Good Research Practices

A Multi-Layered Approach to Botanical Authenticity Fosters Good Research Practices

Dissemination of original NMR data enhances reproducibility and integrity in chemical research.

The notion of data transparency is gaining a strong awareness among the scientific community. The availability of raw data is actually regarded as a fundamental way to advance science by promoting both integrity and reproducibility of research outcomes. Particularly, in the field of natural product and chemical research, NMR spectroscopy is a fundamental tool for structural elucidation and quantification (qNMR). As such, the accessibility of original NMR data, i.e., Free Induction Decays (FIDs), fosters transparency in chemical research and optimizes both peer review and reproducibility of reports by offering the fundamental tools to perform efficient structural verification. Although original NMR data are known to contain a wealth of information, they are rarely accessible along with published data. This viewpoint discusses the relevance of the availability of original NMR data as part of good research practices not only to promote structural correctness, but also to enhance traceability and reproducibility of both chemical and biological results.

Translation and psychometric properties of the Persian version of self-management of type 1 diabetes for adolescents.

The present study was conducted to translate and assess the validation of the measure of self-management of type 1 diabetes for adolescents that developed by Schilling et al [Schilling LS, Knafl KA, Grey M. Changing patterns of self-management in youth with type I diabetes. J Pediatr Nurs 2006;21:412-24]. The first stage of the study involved the translation of the measure of self-management of type 1 diabetes for adolescents into Persian based on the model proposed by Wild et al. in two versions [Wild D, Grove A, Martin M, Eremenco S, McElroy S, et al. Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation. Value Health 2005;8:94-104; Wild D, Eremenco S, Mear I, Martin M, Houchin C, et al. Multinational trials - recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report. Value Health 2009;12:430-40]. The translated versions were reviewed in consultation sessions with experts and the more appropriate items were selected and the final version was translated back into English in two versions and was then sent to the measure's designer for confirmation. The content validity of the measure was then evaluated by a group of experts and found to be acceptable. The next stage evaluated the measure's construct validity. This measure contains 52 items classified under five subscales. The confirmatory factor analysis was performed to assess the measure's construct validity and was found to be acceptable. For evaluating the reliability of the measure, its internal consistency was assessed through calculating its Cronbach's alpha and intra-class correlation. The measure's consistency was measured through calculating its test-retest reliability. The assessment of the measure's content validity revealed a content validity index of 0.98. For the construct validity of the measure using the confirmatory factor analysis, the following figures were obtained: NFI=0.97, RMSA=0.001, AGFI=0.81, IFI=0.833, GFI=0.83. In the assessment of the measure's reliability, the intra-class correlation showed an overall Cronbach's alpha of 0.88. The test-retest showed a consistency of 0.73 for the measure. The validation of the 48-item measure revealed that it can be used in the population of Iranian adolescents with type 1 diabetes (8 items changed their subscales and 4 items were removed).

Practical Considerations for the Use of Clinical Outcome Assessments (COAs) in Pediatric Clinical Research: Examples From Pediatric Gastroenterology.

Clinical outcome assessments (COAs), including patient-reported outcome (PRO) measures, are routinely used in drug development and other clinical research initiatives to assess the impact of treatment on patient health and well-being. The FDA Guidance for Industry Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (2009), the European Medicines Agency's Reflection Paper on the Regulatory Guidance for the Use of Health-Related Quality of Life Measures in the Evaluation of Medicinal Products (2005), and the International Society for Pharmacoeconomics and Outcomes Research PRO Good Research Practices for the Assessment of Children and Adolescence Task Force (2013) outline key considerations and good measurement principles that are relevant to the selection and use of COAs in a pediatric population. However, challenges remain in the appropriate selection and use of COAs to assess treatment benefit in pediatric clinical research. The purpose of this paper is to summarize proceedings from a panel presentation at the Critical Path Institute's 2015 Annual PRO Consortium Workshop. This paper underscores the importance of considering children's specific needs and the numerous challenges faced when developing and implementing well-defined and reliable COAs in pediatric clinical trials evaluating medical products, and describes some approaches to addressing these unique needs and challenges.

Moving Beyond Evaluation to Transit Project Prioritization: Lessons from the Toronto, Ontario, Canada, Context

Governments face critical decisions on how to spend taxpayers’ money and must weigh priorities and come to these decisions in a transparent and defensible way. A prioritization tool can play a critical role in informing spending decisions, ensuring that decisions are made in the interest of the public good, and bolstering public confidence in elected officials and the democratic process. Ideally, a prioritization tool not only evaluates potential projects against a desired set of policy objectives but also prioritizes potential projects into an implementation plan through the integration of pragmatic considerations. Metrolinx, an Ontario, Canada, provincial agency tasked with transportation planning for the greater Toronto and Hamilton area, developed a prioritization framework to make recommendations on capital investment in sustainable transportation. This paper summarizes the current prioritization framework, outlines its limitations, and goes on to explore potential remedies to those limitations as well as inherent challenges. Specifically, the paper discusses incorporating broader considerations, including multimodal integration and active transportation, congestion, network effects, and project interdependencies, and bridging the gap between project evaluation and real-world prioritization. The paper presents best-practice research for each broader consideration and posits that these broader considerations can be used to transform evaluation outputs into prioritized implementation plans.