Correspondence
5
Claxton K. The irrelevance of inference: a decision-making approach to the stochastic evaluation of health care technologies. J Health Econ 1999; 18: 341–64.
Katie Harron, *Ruth Gilbert [email protected] UCL Institute of Child Health, London WC1N 1EH, UK 1
Initiatives to widen the use of administrative data could help to reduce waste in research. 1–3 We suggest recording consent to research in patients’ routinely captured administrative health data to increase value (through improved accountability) and reduce waste (through improved safety surveillance and secondary research). Consent to research is relevant to patients’ health, service providers, planners and funders, and to research. Consent could be routinely recorded in the same way as other health-care procedures without explicit consent other than the generic opt-out applied to all health records.4 No information would be recorded from the study other than the study identifier. In terms of accountability, recording of consent would allow regulatory authorities, service and research funders, and journal editors to audit research undertaken. For example, regulators could assess whether research for licensing of drugs or devices was done in appropriate or representative populations, and journal editors could detect fraud. Most importantly, surveillance for some adverse events could be collected by outcomes captured in longitudinal linked administrative health-care data. In terms of secondary research, outcomes not considered in the original research but captured by administrative data could be investigated, provided investigators release minimum data (with proportionate requirements for consent), such as treatment allocation, for linkage to the patient’s health-care records. Building on the UK Government’s investment in wider use of linked administrative data, linkages could extend to data beyond health, such as school achievement, employment, or social care.2 We declare that we have no competing interests.
1124
2
3
4
Salman RA-S, Beller E, Kagan J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014; 383: 176–85. Economic and Social Research Council. The Big Data Family is born. http://www.esrc.ac.uk/ news-and-events/press-releases/28673/thebig-data-family-is-borndavid-willetts-mpannounces-the-esrc-big-data-network.aspx (accessed Jan 13, 2014). Medical Research Council. £20 million for new health informatics research institute. http:// www.mrc.ac.uk/Newspublications/News/ MRC009207 (accessed Jan 13, 2014). Greenhalgh T, Wood GW, Bratan T, Stramer K, Hinder S. Patients’ attitudes to the summary care record and HealthSpace: qualitative study. BMJ 2008; 336: 1290–95.
the proband and the institution doing the research. From a legal perspective, the responsibility to protect privacy cannot be delegated from the research institution to third parties without contracting them. An adequate approach needs to balance transparency and data safety to minimise the risk of data misuse. New platforms like DataSHIELD4 allow for shared participant-level data analyses and avoid uncontrolled access to individual data. We declare that we have no competing interests.
*Henry Völzke, Carsten O Schmidt, Wolfgang Hoffmann [email protected]
An-Wen Chan and colleagues campaign for publication of original, participant-level data to minimise bias in biomedical research. Recently, examination programmes of population studies have became more and more comprehensive. Thus, latest examinations for the Study of Health in Pomerania2 took 25 h, and there are millions of variables per participant, including information about socioeconomic status, behavioural factors, molecular markers, subclinical disorders, and clinical diseases. Chan and colleagues 1 support publication of individual data in an anonymised fashion. In view of the bulk of variables in comprehensive population research, however, datasets are never really anonymised. Matching age and sex with only one to two continuously distributed variables allows third parties to create a combined dataset from different sources. Application of data mining as a method to select disease predictors from comprehensive datasets3 would even require the publication of most, if not all, individual data. Knowledge of some key indicators and study participation are then sufficient to identify the person behind the proband, especially from studies with large sampling fraction from the target population. In many countries, privacy and data safety are regulated between 1
Institute for Community Medicine, University Medicine Greifswald, D-17487 Greifswald, Germany 1
2
3
4
Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014; 383: 257–66. Volzke H, Alte D, Schmidt CO, et al. Cohort profile: the Study of Health in Pomerania. Int J Epidemiol 2011; 40: 294–307. Volzke H, Schmidt CO, Baumeister SE, et al. Personalized cardiovascular medicine: concepts and methodological considerations. Nat Rev Cardiol 2013; 10: 308–16. Doiron D, Burton P, Marcon Y, et al. Data harmonization and federated analysis of population-based studies: the BioSHaRE project. Emerg Themes Epidemiol 2013; 10: 12.
Artificial labels for research publications are not helpful for medical science. A recommendation made by Iain Chalmers and colleagues1 applies to all research: proposals for research, and research itself, should be “justified by systematic reviews showing what is already known”. More than 200 years ago, the very first sentence of the first article in the first issue of The New England Journal of Medicine read: “In our inquiries into any particular subject of medicine, our labours will generally be shortened and directed to their proper objects, by a knowledge of preceding discoveries”.2 Yet, a subtle but crucial impediment to such condition sine qua none might be the prevailing labelling of, and differentiation between, original and explicitly (or implicitly) other www.thelancet.com Vol 383 March 29, 2014
(non-original) research or publication categories. Clearly, attaching the label original to new results from one individual study alone should be reconsidered. For instance, it was suggested that meta-analyses, when done as a study of studies, could qualify as original work. Moreover, the fact that publications under any heading can offer quality content with wide-ranging effects is indisputable (eg, the landmark publications by Hardy,3 Watson and Crick,4 or Higgs5). Disconcertingly, rather than judging the contents alone, differential academic importance continues to be attached to research or publication categories in the course of tenure processes and when applying for posts and grants. Avoiding an artificial distinction between original research and other work should see an increase in the submission of valuable (and actually badly needed) review articles by researchers who might otherwise be hesitant to invest time into less appreciated work. We declare that we have no competing interests.
*Thomas C Erren, J Valérie Groß, V Benno Meyer-Rochow [email protected] Institute and Policlinic for Occupational Medicine, Environmental Medicine and Prevention Research, University Hospital of Cologne, D-50938 Cologne, Germany (TCE, JVG); and Department of Biology, Oulu University, Oulu, Finland (VBM-R) 1
2 3 4
5
Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156–65. Warren J. Remarks on angina pectoris. N Engl J Med Surg 1812; 1: 1–11. Hardy GH. Mendelian proportions in a mixed population. Science 1908; 28: 49–50. Watson JD, Crick FH. Molecular structure of nucleic acids; a structure for deoxyribose nucleic acid. Nature 1953; 171: 737–38. Higgs PW. Broken symmetries, massless particles and gauge fields. Phys Lett 1964; 12: 132–33.
research priority setting, patients and clinicians are mentioned as the principal users of research. While both these groups are clearly important to setting of research priorities, it is disappointing that no reference is made to health-care commissioners. Commissioners are responsible for buying care on behalf of their populations and ensuring its effective delivery. They therefore have considerable interest in and influence on the design of services and the treatments they paid for. Within the UK, NHS England is the primary body for commissioning health care in England and has a budget of about £100 million, which is spent either directly commissioning some services or through other organisations such as Clinical Commissioning Groups. To make cost-effective decisions at a population level, commissioners need to use the best available evidence and therefore should be considered major users of research evidence. Currently, it is highly likely that substantial sums are wasted on poorly evidenced commissioning decisions. Under the Health and Social Care Act 2012, commissioners in England have a duty to promote research and the use of evidence, and engagement in research priority setting is a key way of exercising this duty. NHS England have set out an ambition to do this.2 Input from commissioners is crucial if service delivery questions and population needs are to be considered alongside the more individualorientated priorities of clinicians and patients. I declare that I have no competing interests.
Peter Brindle [email protected] Bristol Clinical Commissionning Group, Bristol BS1 3NX, UK 1
I applaud the Lancet Series on reducing waste in research which highlights many extremely useful recommendations. In the first paper of the Series, 1 which is related to www.thelancet.com Vol 383 March 29, 2014
2
Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156–65. NHS England. NHS England Research and Development Strategy Consultation. http:// www.england.nhs.uk/ourwork/gov/researchdev-strategy/ (accessed Jan 22, 2014).
The Lancet Series on reducing waste in research is an important contribution from scientists working in institutions in high-income countries.1 For scientists working in institutions in low-income and middle-income countries (LMICs), one source of relevant waste is the scarcity of opportunities to implement research projects derived from original ideas. Funding is needed to test ideas stemming from scientists, stakeholders, and the general public to identify interventions that can improve the health of their populations. Global investments in health research and development reached US$240 billion in 2010, of which $26 billion were spent in LMICs.2 There are many reasons for this inequitable distribution, such as countryspecific fund designations, complex application requirements, and the poor competitiveness of institutions in LMICs. Moreover, scarce research funds in some LMICs are channelled mainly to pure basic research—the “Marie Curie quadrant” mentioned by Iain Chalmers and colleagues in their paper.3 One example is Argentina, an upper-middle-income country that dedicates only 6% of its biomedical research funds to applied clinical and public health research.4 If wasting of research resources is unacceptable for high-income countries, it is outrageous for LMICs. A relevant strategy to reduce waste on research in LMICs is to strengthen centres of excellence on applied research.5,6 LMICs need strong, sustainable, multidisciplinary, and independent research institutions that are capable of designing and doing studies to assess original, feasible, and appropriate priority interventions. These centres of excellence should have: excellent knowledge of research consumers’ needs and expectations; solid infrastructure to undertake innovative and feasible research studies with the goal of generating new knowledge and implementing findings into practice; and the responsibility of building capacity in research methods
Thomas Busk/Science Photo Library
Correspondence
For the Health and Social Care Act 2012 see http://www. legislation.gov.uk/ ukpga/2012/7/pdfs/ ukpga_20120007_en.pdf
1125
5
Claxton K. The irrelevance of inference: a decision-making approach to the stochastic evaluation of health care technologies. J Health Econ 1999; 18: 341–64.
Katie Harron, *Ruth Gilbert [email protected] UCL Institute of Child Health, London WC1N 1EH, UK 1
Initiatives to widen the use of administrative data could help to reduce waste in research. 1–3 We suggest recording consent to research in patients’ routinely captured administrative health data to increase value (through improved accountability) and reduce waste (through improved safety surveillance and secondary research). Consent to research is relevant to patients’ health, service providers, planners and funders, and to research. Consent could be routinely recorded in the same way as other health-care procedures without explicit consent other than the generic opt-out applied to all health records.4 No information would be recorded from the study other than the study identifier. In terms of accountability, recording of consent would allow regulatory authorities, service and research funders, and journal editors to audit research undertaken. For example, regulators could assess whether research for licensing of drugs or devices was done in appropriate or representative populations, and journal editors could detect fraud. Most importantly, surveillance for some adverse events could be collected by outcomes captured in longitudinal linked administrative health-care data. In terms of secondary research, outcomes not considered in the original research but captured by administrative data could be investigated, provided investigators release minimum data (with proportionate requirements for consent), such as treatment allocation, for linkage to the patient’s health-care records. Building on the UK Government’s investment in wider use of linked administrative data, linkages could extend to data beyond health, such as school achievement, employment, or social care.2 We declare that we have no competing interests.
1124
2
3
4
Salman RA-S, Beller E, Kagan J, et al. Increasing value and reducing waste in biomedical research regulation and management. Lancet 2014; 383: 176–85. Economic and Social Research Council. The Big Data Family is born. http://www.esrc.ac.uk/ news-and-events/press-releases/28673/thebig-data-family-is-borndavid-willetts-mpannounces-the-esrc-big-data-network.aspx (accessed Jan 13, 2014). Medical Research Council. £20 million for new health informatics research institute. http:// www.mrc.ac.uk/Newspublications/News/ MRC009207 (accessed Jan 13, 2014). Greenhalgh T, Wood GW, Bratan T, Stramer K, Hinder S. Patients’ attitudes to the summary care record and HealthSpace: qualitative study. BMJ 2008; 336: 1290–95.
the proband and the institution doing the research. From a legal perspective, the responsibility to protect privacy cannot be delegated from the research institution to third parties without contracting them. An adequate approach needs to balance transparency and data safety to minimise the risk of data misuse. New platforms like DataSHIELD4 allow for shared participant-level data analyses and avoid uncontrolled access to individual data. We declare that we have no competing interests.
*Henry Völzke, Carsten O Schmidt, Wolfgang Hoffmann [email protected]
An-Wen Chan and colleagues campaign for publication of original, participant-level data to minimise bias in biomedical research. Recently, examination programmes of population studies have became more and more comprehensive. Thus, latest examinations for the Study of Health in Pomerania2 took 25 h, and there are millions of variables per participant, including information about socioeconomic status, behavioural factors, molecular markers, subclinical disorders, and clinical diseases. Chan and colleagues 1 support publication of individual data in an anonymised fashion. In view of the bulk of variables in comprehensive population research, however, datasets are never really anonymised. Matching age and sex with only one to two continuously distributed variables allows third parties to create a combined dataset from different sources. Application of data mining as a method to select disease predictors from comprehensive datasets3 would even require the publication of most, if not all, individual data. Knowledge of some key indicators and study participation are then sufficient to identify the person behind the proband, especially from studies with large sampling fraction from the target population. In many countries, privacy and data safety are regulated between 1
Institute for Community Medicine, University Medicine Greifswald, D-17487 Greifswald, Germany 1
2
3
4
Chan AW, Song F, Vickers A, et al. Increasing value and reducing waste: addressing inaccessible research. Lancet 2014; 383: 257–66. Volzke H, Alte D, Schmidt CO, et al. Cohort profile: the Study of Health in Pomerania. Int J Epidemiol 2011; 40: 294–307. Volzke H, Schmidt CO, Baumeister SE, et al. Personalized cardiovascular medicine: concepts and methodological considerations. Nat Rev Cardiol 2013; 10: 308–16. Doiron D, Burton P, Marcon Y, et al. Data harmonization and federated analysis of population-based studies: the BioSHaRE project. Emerg Themes Epidemiol 2013; 10: 12.
Artificial labels for research publications are not helpful for medical science. A recommendation made by Iain Chalmers and colleagues1 applies to all research: proposals for research, and research itself, should be “justified by systematic reviews showing what is already known”. More than 200 years ago, the very first sentence of the first article in the first issue of The New England Journal of Medicine read: “In our inquiries into any particular subject of medicine, our labours will generally be shortened and directed to their proper objects, by a knowledge of preceding discoveries”.2 Yet, a subtle but crucial impediment to such condition sine qua none might be the prevailing labelling of, and differentiation between, original and explicitly (or implicitly) other www.thelancet.com Vol 383 March 29, 2014
(non-original) research or publication categories. Clearly, attaching the label original to new results from one individual study alone should be reconsidered. For instance, it was suggested that meta-analyses, when done as a study of studies, could qualify as original work. Moreover, the fact that publications under any heading can offer quality content with wide-ranging effects is indisputable (eg, the landmark publications by Hardy,3 Watson and Crick,4 or Higgs5). Disconcertingly, rather than judging the contents alone, differential academic importance continues to be attached to research or publication categories in the course of tenure processes and when applying for posts and grants. Avoiding an artificial distinction between original research and other work should see an increase in the submission of valuable (and actually badly needed) review articles by researchers who might otherwise be hesitant to invest time into less appreciated work. We declare that we have no competing interests.
*Thomas C Erren, J Valérie Groß, V Benno Meyer-Rochow [email protected] Institute and Policlinic for Occupational Medicine, Environmental Medicine and Prevention Research, University Hospital of Cologne, D-50938 Cologne, Germany (TCE, JVG); and Department of Biology, Oulu University, Oulu, Finland (VBM-R) 1
2 3 4
5
Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156–65. Warren J. Remarks on angina pectoris. N Engl J Med Surg 1812; 1: 1–11. Hardy GH. Mendelian proportions in a mixed population. Science 1908; 28: 49–50. Watson JD, Crick FH. Molecular structure of nucleic acids; a structure for deoxyribose nucleic acid. Nature 1953; 171: 737–38. Higgs PW. Broken symmetries, massless particles and gauge fields. Phys Lett 1964; 12: 132–33.
research priority setting, patients and clinicians are mentioned as the principal users of research. While both these groups are clearly important to setting of research priorities, it is disappointing that no reference is made to health-care commissioners. Commissioners are responsible for buying care on behalf of their populations and ensuring its effective delivery. They therefore have considerable interest in and influence on the design of services and the treatments they paid for. Within the UK, NHS England is the primary body for commissioning health care in England and has a budget of about £100 million, which is spent either directly commissioning some services or through other organisations such as Clinical Commissioning Groups. To make cost-effective decisions at a population level, commissioners need to use the best available evidence and therefore should be considered major users of research evidence. Currently, it is highly likely that substantial sums are wasted on poorly evidenced commissioning decisions. Under the Health and Social Care Act 2012, commissioners in England have a duty to promote research and the use of evidence, and engagement in research priority setting is a key way of exercising this duty. NHS England have set out an ambition to do this.2 Input from commissioners is crucial if service delivery questions and population needs are to be considered alongside the more individualorientated priorities of clinicians and patients. I declare that I have no competing interests.
Peter Brindle [email protected] Bristol Clinical Commissionning Group, Bristol BS1 3NX, UK 1
I applaud the Lancet Series on reducing waste in research which highlights many extremely useful recommendations. In the first paper of the Series, 1 which is related to www.thelancet.com Vol 383 March 29, 2014
2
Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet 2014; 383: 156–65. NHS England. NHS England Research and Development Strategy Consultation. http:// www.england.nhs.uk/ourwork/gov/researchdev-strategy/ (accessed Jan 22, 2014).
The Lancet Series on reducing waste in research is an important contribution from scientists working in institutions in high-income countries.1 For scientists working in institutions in low-income and middle-income countries (LMICs), one source of relevant waste is the scarcity of opportunities to implement research projects derived from original ideas. Funding is needed to test ideas stemming from scientists, stakeholders, and the general public to identify interventions that can improve the health of their populations. Global investments in health research and development reached US$240 billion in 2010, of which $26 billion were spent in LMICs.2 There are many reasons for this inequitable distribution, such as countryspecific fund designations, complex application requirements, and the poor competitiveness of institutions in LMICs. Moreover, scarce research funds in some LMICs are channelled mainly to pure basic research—the “Marie Curie quadrant” mentioned by Iain Chalmers and colleagues in their paper.3 One example is Argentina, an upper-middle-income country that dedicates only 6% of its biomedical research funds to applied clinical and public health research.4 If wasting of research resources is unacceptable for high-income countries, it is outrageous for LMICs. A relevant strategy to reduce waste on research in LMICs is to strengthen centres of excellence on applied research.5,6 LMICs need strong, sustainable, multidisciplinary, and independent research institutions that are capable of designing and doing studies to assess original, feasible, and appropriate priority interventions. These centres of excellence should have: excellent knowledge of research consumers’ needs and expectations; solid infrastructure to undertake innovative and feasible research studies with the goal of generating new knowledge and implementing findings into practice; and the responsibility of building capacity in research methods
Thomas Busk/Science Photo Library
Correspondence
For the Health and Social Care Act 2012 see http://www. legislation.gov.uk/ ukpga/2012/7/pdfs/ ukpga_20120007_en.pdf
1125
