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A research project is not finished until we have written it up. Scientific reports have a standard format, with some variation. This should be familiar from your reading. This chapter builds on the general advice for writing in Chapter 14 and focusses on how to write a scientific report. I provide general guidance for writing your report, then cover each section of the manuscript in turn. I focus on primary research articles, because these are the main way in which we disseminate new research. Much of the advice applies more generally to theses and dissertations. Most reports have multiple authors and we must negotiate authorship fairly.
Good research design includes choosing what to measure and how to measure it. We can’t measure everything. Fortunately, clear predictions dictate the measurements we need to make to test them. This chapter provides general advice on methods, then covers the importance of the validity, accuracy, sensitivity of the measures we use. I end with a reminder that methods must also be feasible.
Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation advances regulatory science and the assessment of FDA REMS programs when using physician surveys. We: (1) reviewed published physician survey response rates; and (2) assessed response bias in a simulation study of secondary survey data using different accrual cut-off strategies.
A systematic literature review was conducted of US physician surveys (2000–2014) on pharmaceutical use (n = 75). Kruskal–Wallis tests were used to examine the relationships between response rates and survey design characteristics. The simulation was conducted using secondary data from a population-based physician KAB survey on diabetes risk management with antipsychotic use in Missouri Medicaid (n = 973 accrued over 30 weeks). Survey item responses were compared using Pearson’s chi-square tests for two faster completion simulations: Fixed Sample (n = 300) and Fixed Time (8 weeks).
Survey response rates ranged from 7% to 100% (median = 48%, IQR = 34%–68%). Surveys of targeted populations and surveys using member lists were associated with higher response rates (p = 0.02). In the simulation, 9 of 20 (45%) KAB items, including diabetes screening advocacy, differed significantly using the smaller Fixed Sample strategy (achieved in 12 days) versus full accrual. Fewer response differences were found using the Fixed Time strategy (2 of 20 [10%] items).
Published data on physician surveys report low response rates with most associated with the sample source selected. FDA REMS assessments should include formal evaluation of survey accrual and response bias.
The chapter introduces the research puzzle of the study: under what conditions do warnings about impending violent conflict in other states succeed in persuading foreign policy-makers to pay more attention, shift their attitudes and mobilise for preventive or mitigating action? Why are some warnings by some sources noticed and largely accepted, while others are ignored, disbelieved or simply not acted upon? The introduction reviews briefly the literature on the warning–response gap in intelligence and peace studies and makes the case for recasting the problem as one of persuasion. It defines and conceptualises what warnings are, their different claims and varied impact. It argues that only by explaining differences in persuasiveness can prospective warners learn the right lessons. To tackle the questions, the chapter introduces the comparative and longitudinal research design, the methods used and data gathered. The chapter concludes by outlining briefly the structure of the book.
The Developmental Origins of Disease hypothesis has spurred increased interest in how prenatal exposures affect lifelong health, while mechanisms such as epigenetics may explain the multigenerational influences on health. Such factors are not well captured within conventional epidemiologic study designs. We explored the feasibility of collecting information on the offspring and grand-offspring of participants in a long-running study.
The Bogalusa Heart Study is a study, begun in 1973, of life-course cardiovascular health in a semirural population (65% white and 35% black).
Female participants who had previously provided information on their pregnancies were contacted to obtain contact information for their daughters aged 12 and older. Daughters were then contacted to obtain reproductive histories, and invited for a clinic or lab visit to measure cardiovascular risk factors.
Two hundred seventy-four daughters of 208 mothers were recruited; 81% (223) had a full clinic visit and 19% (51) a phone interview only. Forty-five percent of the daughters were black, and 55% white. Mean and median age at interview was 27, with 15% under the age of 18. The strongest predictors of participation were black race, recent maternal participation in the parent study, and living in or near Bogalusa. Simple correlations for cardiovascular risk factors across generations were between r = 0.19 (systolic blood pressure) and r = 0.39 (BMI, LDL).
It is feasible to contact the children of study participants even when participants are adults, and initial information on the grandchildren can also be determined in this manner.
Global inequity in access to and availability of essential mental health services is well recognized. The mental health treatment gap is approximately 50% in all countries, with up to 90% of people in the lowest-income countries lacking access to required mental health services. Increased investment in global mental health (GMH) has increased innovation in mental health service delivery in LMICs. Situational analyses in areas where mental health services and systems are poorly developed and resourced are essential when planning for research and implementation, however, little guidance is available to inform methodological approaches to conducting these types of studies. This scoping review provides an analysis of methodological approaches to situational analysis in GMH, including an assessment of the extent to which situational analyses include equity in study designs. It is intended as a resource that identifies current gaps and areas for future development in GMH. Formative research, including situational analysis, is an essential first step in conducting robust implementation research, an essential area of study in GMH that will help to promote improved availability of, access to and reach of mental health services for people living with mental illness in low- and middle-income countries (LMICs). While strong leadership in this field exists, there remain significant opportunities for enhanced research representing different LMICs and regions.
Growing evidence from across the cognitive sciences indicates that iconicity plays an important role in a number of fundamental language processes, spanning learning, comprehension, and online use. One benefit of this recent upsurge in empirical work is the diversification of methods available for measuring iconicity. In this paper, we provide an overview of methods in the form of a ‘toolbox’. We lay out empirical methods for measuring iconicity at a behavioural level, in the perception, production, and comprehension of iconic forms. We also discuss large-scale studies that look at iconicity on a system-wide level, based on objective measures of similarity between signals and meanings. We give a detailed overview of how different measures of iconicity can better address specific hypotheses, providing greater clarity when choosing testing methods.
Objectives: An important question in longitudinal research is whether the individuals who discontinue participation differ in their level of, or their change in, cognitive functioning relative to individuals who return for subsequent occasions. Methods: Performance in five cognitive domains was examined in nearly 5000 participants between 18 and 85 years of age who completed between one and five longitudinal occasions. Results: Little or no differences in cognitive performance were apparent between young adults who did or did not return for subsequent longitudinal occasions. However, among adults above about 45 years of age, returning participants had higher levels of cognitive performance, but approximately similar magnitude of longitudinal change, as participants completing fewer occasions. Conclusions: These results suggest that generalizability of longitudinal comparisons may be restricted to individuals with relatively high levels of cognitive functioning, but that rates of cognitive change are nearly comparable for individuals completing different numbers of longitudinal occasions.
Methane is the second most important anthropogenically produced greenhouse gas, and radiocarbon (14C) analysis is extremely valuable in identifying its age and source in the environment. At the NERC Radiocarbon Facility (East Kilbride, UK) we have developed expertise in analysis of methane 14C concentration and methodological approaches to field sampling over the past 20 years. This has opened a wide range of applications, which have mainly focused on (1) the age and source of methane emitted by peatlands and organic soils (e.g. to quantify the release of ancient carbon), (2) the source of aquatic emissions of methane, and (3) the age of methane generated by amenity and illegal landfill. Many of these scientifically important applications involve challenging sampling and measurement considerations, which our development program has continually aimed to overcome. Here, we describe our current methods, and recent improvements to aid field collection of samples in remote locations. We present the results of tests which (1) show the effectiveness of our methods to remove contaminants, especially CO2, (2) quantify the 14C background contribution, and (3) demonstrate the reliability of metal gas storage canisters for sample storage.
Cardiac surgery-associated acute kidney injury is common. In order to improve our understanding of acute kidney injury, we formed the multi-centre Neonatal and Pediatric Heart and Renal Outcomes Network. Our main goals are to describe neonatal kidney injury epidemiology, evaluate variability in diagnosis and management, identify risk factors, investigate the impact of fluid overload, and explore associations with outcomes.
The Neonatal and Pediatric Heart and Renal Outcomes Network collaborative includes representatives from paediatric cardiac critical care, cardiology, nephrology, and cardiac surgery. The collaborative sites and infrastructure are part of the Pediatric Cardiac Critical Care Consortium. An acute kidney injury module was developed and merged into the existing infrastructure. A total of twenty-two participating centres provided data on 100–150 consecutive neonates who underwent cardiac surgery within the first 30 post-natal days. Additional acute kidney injury variables were abstracted by chart review and merged with the corresponding record in the quality improvement database. Exclusion criteria included >1 operation in the 7-day study period, pre-operative renal replacement therapy, pre-operative serum creatinine >1.5 mg/dl, and need for extracorporeal support in the operating room or within 24 hours after the index operation.
A total of 2240 neonatal patients were enrolled across 22 centres. The incidence of acute kidney injury was 54% (stage 1 = 31%, stage 2 = 13%, and stage 3 = 9%).
Neonatal and Pediatric Heart and Renal Outcomes Network represents the largest multi-centre study of neonatal kidney injury. This new network will enhance our understanding of kidney injury and its complications.
There is no established methodology to assess the feasibility of medicine price data sources. Against this backdrop, a framework to guide the selection of most appropriate price data sources for pharmacoeconomic research has been developed.
A targeted literature review was carried out. Dimensions discussed in literature as relevant for medicine price comparisons and practical experience of the authors in medicine price studies informed the conceptional work of the framework development. A draft version of the framework was reviewed by peer pricing experts. The feasibility of the framework was tested in case studies.
According to the developed framework (called Re-ADAPT), a medicine price data source should meet the following criteria: reliability and sustainability; accessibility at a cost that users can afford; provision of medicine price information at the date(s) required; information for the defined geographic area, or at least in a representative way; coverage of the pharmaceuticals and at the price type(s) required. Easy handling and provision of additional information were defined as supportive assets of candidate data sources (secondary criteria). The case studies confirmed the feasibility of the Re-ADAPT framework. In some cases, however, it can be difficult to disentangle assessment criteria (particularly geographic area, scope of pharmaceuticals and price types) for separate consideration, given their interlinkage.
While selection of the most appropriate data sources will remain a challenge, the Re-ADAPT framework aims to provide practical guidance and thus contribute to a more careful, balanced, and evidence-based selection of data sources for medicine price studies.
Social and cultural aspects are rarely assessed in health technology assessments (HTA), despite being part of most HTA definitions. One hypothesis for the reason why they are hardly considered in HTA is that we lack relevant assessment methods. Accordingly, this review aims at providing an overview of methodological approaches to address social and cultural aspects related to health technologies in HTA.
We conducted a comprehensive literature search by searching fourteen databases and a hand-search of two pertinent journals. Additionally, we sent a query to all member agencies of the International Network of Agencies for Health Technology Assessment (INAHTA) asking them for methods they use to assess social and cultural aspects.
A total of 125 publications met our inclusion criteria. We grouped the methodological approaches into checklists for experts, literature reviews, stakeholder participatory approaches, primary data collection methods, and combinations of methodological approaches.
There is a wide variety of methods available for assessing social and cultural aspects of health technologies, some of which have been applied in HTA. The presented overview of the different approaches and their merits can facilitate the assessment of these aspects, and improve the knowledge regarding (potential) success and failure of the implementation of a health technology.
Determining (1) the direction of causation and (2) the size of causal effects between two constructs is a central challenge of the scientific study of humans. In the early 1990s, researchers in behavioral genetics invented what was termed the direction of causation (DoC) model to address exactly these two concerns. The model claims that for any two traits whose mode of inheritance is sufficiently different, the direction of causation can be ascertained using a sufficiently large genetically informative sample. Using a series of simulation studies, we demonstrate a major challenge to the DoC model, namely that it is extremely sensitive to even tiny amounts of non-shared confounding. Even under ideal conditions for the DoC model (a large sample, N = 10,000), a large causal relationship (e.g., a causal correlation of .50) with very different modes of inheritance between the two traits (e.g., a pure AE model for one trait and a pure CE model for another trait) and a modest degree (correlation of .10) of non-shared confounding between the two traits results in the choice of the wrong causal models and estimating the wrong causal effects.
Common understandings of neuroethics, that is, of its distinctive nature, are premised on two distinct sets of claims: (1) neuroscience can change views about the nature of ethics itself and neuroethics is dedicated to reaping such an understanding of ethics, and (2) neuroscience poses challenges distinct from other areas of medicine and science and neuroethics tackles those issues. Critiques have rightfully challenged both claims, stressing how the first may lead to problematic forms of reductionism whereas the second relies on debatable assumptions about the nature of bioethics specialization and development. Informed by philosophical pragmatism and our experience in neuroethics, we argue that these claims are ill founded and should give way to pragmatist reconstructions; namely, that neuroscience, much like other areas of empirical research on morality, can provide useful information about the nature of morally problematic situations, but does not need to promise radical and sweeping changes to ethics based on neuroscientism. Furthermore, the rationale for the development of neuroethics as a specialized field need not to be premised on the distinctive nature of the issues it tackles or of neurotechnologies. Rather, it can espouse an understanding of neuroethics as both a scholarly and a practical endeavor dedicated to resolving a series of problematic situations raised by neurological and psychiatric conditions.
Britain has long taken a firm public line against terrorist ransom, insisting that yielding to terrorist demands only encourages further acts of intimidation and kidnapping. Hitherto, academic research has tended to take these assertions of piety at face value. This article uses a historical approach to show that the British position has shifted over time and was often more complex and pragmatic. Indeed, Britain’s position with regard to kidnap and ransom insurance has, until quite recently, been rather ambiguous. We use the British case to suggest that, rather than dividing states into groups that make concessions and those that do not, it is perhaps better to recognise there is often a broad spectrum of positions, sometimes held by different parts of the same government, together with the private security companies that move in the shadows on their behalf. One of the few things that unites them is a tendency to dissemble and this presents some intriguing methods problems for researchers.
Efficient and economical herd management depends a great deal on maintaining a short, well-defined calving season. This requires highly fertile females and bulls. Low pregnancy rates are very noticeable, however; potentially greater economic loss may be due to delayed conception. Many studies showed that approximately one of every five bulls had inadequate semen quality, physical soundness, or both, but when evaluation of serving capacity is included about one in four bulls is unsatisfactory. Due mainly to the time and expense that the market will bear, usually only physical soundness and semen quality are evaluated. Breeding soundness evaluation is a useful, low-cost screening method for reducing the risk of using low fertility bulls. The biggest problem with breeding soundness evaluations is not our lack of knowledge or ability, but in the willingness of veterinary schools to provide adequate equipment and training in this area, a lack of diagnostic laboratories equipped to handle the more difficult cases and, most importantly, the weaknesses of human nature that result in negligent testing procedure.