Assessing the payback from health R & D: From ad hoc studies to regular monitoring

Chapter 1 : Introduction • The increasing demands for the benefits of payback from publicly funded R&D to be assessed are based partly on the need to justify or account for expenditure on R&D, and partly on the desire for information to assist resource allocation and the better management of R&D funds. The former consideration is particularly strong in relation to the R&D expenditure that comes out of the wider NHS budget. • In this report a range of categories of payback will be identified along with a variety of methods for assessing them. • The aim of the report is to make recommendations as to how the outcomes from health research might best be monitored on a regular basis. The specific context of the report is the NHS R&D Programme but many of the issues will be relevant for a wide range of funders of health R&D. • The introduction sets out not only a plan of the report but also suggests that readers familiar with the general arguments and existing literature may choose to jump to Chapter 6. Chapter 2 : Review of Existing Approaches to Assessing the Payback from Research • Existing work describes various approaches to valuing research. Some are ex ante and attempt to predict the outcomes of research being considered, others are ex post or retrospective. • The five categories of benefit or payback from health R&D that have been identified involve contributions: to knowledge; to research capacity and future research; to improved information for decision making; to the efficiency, efficacy and equity of health care services; and to the nation’s economic performance. These are shown in Table 1 of the report • The process by which R&D generates final outcomes can be modelled as a sequence. This includes primary outputs such as publications; secondary outputs in the form of policy or administrative decisions; and final outcomes which comprise the health and economic benefits. Feedback loops are also introduced and mitigate the limitations of a linear approach. • Qualitative and quantitative approaches can be used but there are immense problems with time lags and attributing outcomes, and sometimes even outputs, to specific items of research funding. • Four common methods of measuring payback can be used. Expert review, by peers or, sometimes, users is the traditional way of assessing the quality of research. Bibliometric techniques can involve not only counting publications but also using datasets such as the Science Citation Index and Wellcome’s Research Outputs Database (ROD). The various methods of economic analysis of payback are difficult to undertake given the costs and problems of acquiring relevant information and estimating benefits. Social science methods include case studies, which can provide useful information but are resource intensive, and questionnaires to researchers and potential research users. Chapter 3 : Characteristics of a Routine Monitoring System • In moving from ad hoc or research studies of payback towards a more regular monitoring it is noted that whereas there has always been a tradition of evaluation of research, in the public services in general there is now a greater emphasis on audit and performance measurement and indicators. A review of these various systems suggests we should be looking to develop a system of outcomes monitoring that incorporates performance indicators (PIs) and measurement rather than an audit system that is trying to monitor activities against predetermined targets. • Standard characteristics of performance measurement systems do not necessarily apply to research where, for example, there are non-standard outputs. Difficulties have arisen in the USA in attempting to apply the Government Performance and Results Act to research funding agencies. It is shown that because the findings of basic research, in particular, enter a knowledge pool in which people and ideas interact, it is difficult to use a PIs’ approach to track eventual outcomes. However, for some types of health research it has proved more feasible to trace the flow between research outputs and outcomes. • An outcomes monitoring system could be useful if it met the following criteria: relevant to, with as comprehensive coverage as possible of, the funders objectives; relevant to the funder’s decision making processes; encourages accurate compliance; minimises unintended consequences; and has acceptable costs. Chapter 4 : Differences Between Research Types • The range of differences between types of research can be relevant for the design of a routine monitoring system. The OECD distinguishes between basic research, applied research and experimental development. Most DH/NHS research is applied. There might be more of a tradition of publication of findings in applied research in health than in other fields. Nevertheless, the publication and incentives patterns operating in basic research mean that it would be inappropriate to use bibliometric indicators in a simple way across all fields even in health research. • Despite having some differences from health research in publication patterns and in the detailed categories of payback, the broad approach proposed in Chapter 6 could be applied to social care research. • Research that is commissioned, especially by the government, has some of the minimum conditions built into it that are associated with outcomes being generated, in particular because the funder has identified that a contribution in this area will be valuable. Chapter 5 : What Units of Research? • The term programme has various meanings including being used to describe a collection of projects on a common theme and to describe a block of funding for a research unit. • Three main streams or modes of funding can be identified: projects, which are administratively grouped into programmes including a responsive programme; institutions/centres/units; individual researchers. These 3 streams are displayed in Figure 1. It is probable that the regular data-gathering for a monitoring system would operate at the basic level of each stream or mode. • Previous work demonstrates that the full range of benefits can sometimes be applied at the level of projects, either in the responsive mode or in programmes, through the use of questionnaires to researchers. Expert and user review and user surveys have also been applied. • Institutions and centres increasingly have experience not only of traditional periodic expert review but also of producing annual reports, although there are debates about what dimensions to include in such reviews and reports. • Individuals in receipt of research development awards have completed questionnaires during and after the awards. These concentrate on the development of research capacity but can go wider. Chapter 6 : A Possible Comprehensive Outcomes Monitoring System • The proposed system is intended for DH/NHS to monitor the outcomes from its R&D in order to justify the R&D expenditure and assist with managing the portfolio. More detailed information is required for the latter purpose. • We propose a multidimensional approach be adopted to cover all the dimensions of payback and that information be gathered from three sets of sources and Table 3 shows which methods would cover which output/outcome categories. • Firstly, possibly annually, a questionnaire (possibly electronic) covering most payback categories should gather data from the basic level of each funding stream ie. from lead researchers of projects, from research institutions/centres, and from individual award holders. • Secondly, supplementary information should be gathered from external databases (including the citation indices and Wellcome’s ROD). • Thirdly, a range of approaches ie. user surveys, reviews by experts and peers, case studies including economic evaluations, and analysis of sources used in policy documents such as NICE guidelines, would be undertaken on a sample basis. They would provide not only supplementary information but, as with the external databases, would also verify the data collected directly from researchers. • These proposals can be evaluated against the criteria set out in Chapter 3: • The system is relevant to DH’s objectives of generating payback in a range of categories. • Various problems have to be overcome before the system could be fully decision relevant. Firstly it might be necessary to ask researchers to apportion the contribution made to specific outputs from various funding streams. Second, to be decision relevant the information would have to be analysed and presented in a manner consistent with funders’ decision making processes. This would involve a) showing how for each outcome and output, for example publications, data from one project or stream could be compared with those from another and b) demonstrating how different outputs and outcomes could be aggregated. • The questions of accuracy of data, minimisation of unintended consequences and the acceptability of the net costs are also addressed. Chapter 7 : Research and Monitoring • Whilst this report is primarily concerned with moving from ad hoc studies towards a routine monitoring system there are issues that need further research. • Before embarking on full implementation the feasibility needs to be tested of items such as on-line recording of data and asking researchers to attribute proportions of research outputs to separate funding agencies. • Once the system is implemented the value of some items can be better assessed, for example the additional value provided by self reporting of publications beyond that gained from relying on external databases. • The data provided by the system would provide opportunities for further payback research on, for example, links between publications and other categories of payback. • Some items such as network analysis could potentially be added to the monitoring system after further examination of them. • Finally the benefit from the monitoring system itself should be assessed.Department of Health; Wellcome Trus

The utilisation of health research in policy-making: Concepts, examples and methods of assessment

The importance of health research utilisation in policy-making, and of understanding the mechanisms involved, is increasingly recognised. Recent reports calling for more resources to improve health in developing countries, and global pressures for accountability, draw greater attention to research-informed policy-making. Key utilisation issues have been described for at least twenty years, but the growing focus on health research systems creates additional dimensions. The utilisation of health research in policy-making should contribute to policies that may eventually lead to desired outcomes, including health gains. In this article, exploration of these issues is combined with a review of various forms of policy-making. When this is linked to analysis of different types of health research, it assists in building a comprehensive account of the diverse meanings of research utilisation. Previous studies report methods and conceptual frameworks that have been applied, if with varying degrees of success, to record utilisation in policy-making. These studies reveal various examples of research impact within a general picture of underutilisation. Factors potentially enhancing utilisation can be identified by exploration of: priority setting; activities of the health research system at the interface between research and policy-making; and the role of the recipients, or 'receptors', of health research. An interfaces and receptors model provides a framework for analysis. Recommendations about possible methods for assessing health research utilisation follow identification of the purposes of such assessments. Our conclusion is that research utilisation can be better understood, and enhanced, by developing assessment methods informed by conceptual analysis and review of previous studies

Connectivity-based parcellation of the human frontal polar cortex

The frontal pole corresponds to Brodmann area (BA) 10, the largest single architectonic area in the human frontal lobe. Generally, BA10 is thought to contain two or three subregions that subserve broad functions such as multitasking, social cognition, attention, and episodic memory. However, there is a substantial debate about the functional and structural heterogeneity of this large frontal region. Previous connectivity-based parcellation studies have identified two or three subregions in the human frontal pole. Here, we used diffusion tensor imaging to assess structural connectivity of BA10 in 35 healthy subjects and delineated subregions based on this connectivity. This allowed us to determine the correspondence of structurally based subregions with the scheme previously defined functionally. Three subregions could be defined in each subject. However, these three subregions were not spatially consistent between subjects. Therefore, we accepted a solution with two subregions that encompassed the lateral and medial frontal pole. We then examined resting-state functional connectivity of the two subregions and found significant differences between their connectivities. The medial cluster was connected to nodes of the default-mode network, which is implicated in internally focused, self-related thought, and social cognition. The lateral cluster was connected to nodes of the executive control network, associated with directed attention and working memory. These findings support the concept that there are two major anatomical subregions of the frontal pole related to differences in functional connectivity

Differences in Frontal Network Anatomy Across Primate Species

The frontal lobe is central to distinctive aspects of human cognition and behavior. Some comparative studies link this to a larger frontal cortex and even larger frontal white matter in humans compared with other primates, yet others dispute these findings. The discrepancies between studies could be explained by limitations of the methods used to quantify volume differences across species, especially when applied to white matter connections. In this study, we used a novel tractography approach to demonstrate that frontal lobe networks, extending within and beyond the frontal lobes, occupy 66% of total brain white matter in humans and 48% in three monkey species: vervets (Chlorocebus aethiops), rhesus macaque (Macaca mulatta) and cynomolgus macaque (Macaca fascicularis), all male. The simian- human differences in proportional frontal tract volume were significant for projection, commissural, and both intralobar and interlobar association tracts. Among the long association tracts, the greatest difference was found for tracts involved in motor planning, auditory memory, top-down control of sensory information, and visuospatial attention, with no significant differences in frontal limbic tracts important for emotional processing and social behaviour. In addition, we found that a nonfrontal tract, the anterior commissure, had a smaller volume fraction in humans, suggesting that the disproportionally large volume of human frontal lobe connections is accompanied by a reduction in the proportion of some nonfrontal connections. These findings support a hypothesis of an overall rearrangement of brain connections during human evolution.</p

Recurrence of Cardiovascular Events in Patients With Type 2 Diabetes : Epidemiology and risk factors

OBJECTIVE—The purpose of this study was to assess incidence of and risk factors for recurrent cardiovascular disease (CVD) in type 2 diabetes

Methodological issues in epidemiological studies of periodontitis - how can it be improved?

Background: This position paper was commissioned by the European Association of Dental Public Health, which has established six working groups to investigate the current status of six topics related to oral public health. One of these areas is epidemiology of periodontal diseases. Methods: Two theses "A systematic review of definitions of periodontitis and the methods that have been used to identify periodontitis" [1] and "Factors affecting community oral health care needs and provision" [2] formed the starting point for this position paper. Additional relevant and more recent publications were retrieved through a MEDLINE search. Results: The literature reveals a distinct lack of consensus and uniformity in the definition of periodontitis within epidemiological studies. There are also numerous differences in the methods used. The consequence is that data from studies using differing case definitions and differing survey methods are not easily interpretable or comparable. The limitations of the widely used Community Periodontal Index of Treatment Need (CPITN) and its more recent derivatives are widely recognized. Against this background, this position paper reviews the current evidence base, outlines existing problems and suggests how epidemiology of periodontal diseases may be improved. Conclusions: The remit of this working group was to review and discuss the existing evidence base of epidemiology of periodontal diseases and to identify future areas of work to further enhance it

Research protocol: general practice organ donation intervention-a feasibility study (GPOD)

BACKGROUND: New interventions are required to increase the number of people donating their organs after death. In the United States of America (USA), general practice has proved to be a successful location to increase organ donor registration. However, a dearth of research exists examining this in the United Kingdom (UK). due to the unique challenges presented by the National Health Service (NHS). This protocol outlines a feasibility study to assess whether UK general practice is a feasible and acceptable location for organ donation intervention targeting NHS Organ Donor Register (NHS ODR) membership. METHODS: The primary intervention element, prompted choice, requires general practice to ask patients in consultations if they wish to join the NHS ODR. Two additional intervention techniques will be used to support prompted choice: staff training and leaflets and posters. The intervention will run for 3 months (April-July 2018) followed by a period of data collection. The following methods will be used to assess feasibility, acceptability and fidelity: registration data, a training evaluation survey, focus groups with staff and online surveys for staff and patients. DISCUSSION: By examining the feasibility, acceptability and fidelity of a prompted choice intervention in UK general practice, important knowledge can be gathered on whether it is a suitable location to conduct this. Additional learning can also be gained generally for implementing interventions in general practice. This could contribute to the knowledge base concerning the feasibility of NHS general practice to host interventions

Glutamine-to-glutamate ratio in the nucleus accumbens predicts effort-based motivated performance in humans

Substantial evidence implicates the nucleus accumbens in motivated performance, but very little is known about the neurochemical underpinnings of individual differences in motivation. Here, we applied 1H magnetic resonance spectroscopy (1H-MRS) at ultra-high-field in the nucleus accumbens and inquired whether levels of glutamate (Glu), glutamine (Gln), GABA or their ratios predict interindividual differences in effort-based motivated task performance. Given the incentive value of social competition, we also examined differences in performance under self-motivated or competition settings. Our results indicate that higher accumbal Gln-to-Glu ratio predicts better overall performance and reduced effort perception. As performance is the outcome of multiple cognitive, motor and physiological processes, we applied computational modeling to estimate best-fitting individual parameters related to specific processes modeled with utility, effort and performance functions. This model-based analysis revealed that accumbal Gln-to-Glu ratio specifically relates to stamina; i.e., the capacity to maintain performance over long periods. It also indicated that competition boosts performance from task onset, particularly for low Gln-to-Glu individuals. In conclusion, our findings provide novel insights implicating accumbal Gln and Glu balance on the prediction of specific computational components of motivated performance. This approach and findings can help developing therapeutic strategies based on targeting metabolism to ameliorate deficits in effort engagement