Book review Developing a unified patient record: a practical guide
5 July, 2004

Deb Thompson
Kim Wright

Radcliffe Medical Press
2003, pp 140

ISBN

Groningen University Medical Centre (GUMC)
85775 9397

Book review Developing a unified patient record: a practical guide

International Journal of Integrated Care
45 July, 20041
This is what we read on the back flap: 'This comprehensive and practical guide helps professionals and staff within hospitals change the way they collect, store and use clinical information about patients. It illustrates how clinical governance and evidence-based practice can be easily addressed by modernising clinical information practice, to benefit patients and improve staff and service efficiency.'

This is a clear description of what the authors want to carry out with this book. Because it is mainly focussed on the hospital situation, there seems not a direct relationship with integrated care. But one can say: if you do the recording of patient information in the hospital in a good way, it will have a positive effect on the health care facilities outside the hospital (home care, nursing care homes, general practitioner etc.).

This very handsome and readable book is based on the experiences of two well-qualified nurses from the United Kingdom. And for this reason it is written in a practical way; what you see is what you get! The book contains nine chapters. One very positive aspect is the multidisciplinary approach to patient-focused care. All chapters are illustrated with a lot of practical examples and figures.

After a short introductory chapter, one can read in Chapter 2 about the ins and outs of a unified patient record. In Chapter 3, the focus is on the need to base practice on evidence, and the use of care guides as a practical tool to enable this to happen. In Chapters 4 and 5 the authors focus on clinical record keeping and the concept of the electronic patient record, and the ways in which they are inextricably linked. In Chapter 6 is described some of the characteristics of change. This includes a review of clinical projects resulting in successful change. Also examples are given of strategies and models that can be used in the implementation and subsequent evaluation of the unified patient record (UPR). After a short chapter on frequently asked quuestions Chapter 8 is very practical in its intention. It gives practical advice about carrying out a project, a so-called 'Toolkit'. In Chapter 9, the last chapter, one can read an extensive example of a UPR. The book ends with a Glossary of terms, advices for further reading and, last but not least, an index.

For those who want to start with a unified patient record, one can read Chapter 8. In this chapter, a toolkit is presented for the development of a UPR. Although the content is written for the situation in the UK, everyone who is interested in this integrated care record can use some of the practical advice from this book.

Finally, the best tip given is: 'A touch of humour always helps' (p. 95).

Han de Ruiter


ISSUE BRIEF Academic Research Budgets A Look Ahead with Special Emphasis on Research Enablement and Support
February 25, 2021

Jane Radecki
Roger C Schonfeld
ISSUE BRIEF Academic Research Budgets A Look Ahead with Special Emphasis on Research Enablement and Support
February 25, 2021
Ithaka S+R provides research and strategic guidance to help the academic and cultural communities serve the public good and navigate economic, demographic, and technological change. Ithaka S+R is part of ITHAKA, a not-for-profit organization that works to advance and preserve knowledge and to improve teaching and learning through the use of digital technologies. Artstor, JSTOR, and Portico are also part of ITHAKA.

The United States university sector's research enterprise is an important national asset. It is highly competitive and highly innovative in ordinary times, and during the past year plagued by coronavirus it pivoted quickly to conduct urgently needed research on a new threat. Beyond its national and international significance, the research enterprise is also an enormous assetintellectually and financially-for each of the individual universities with a major stake in it.

At the high level, the pandemic may seem not to have done lasting damage. Indeed, in the current economic downturn, while universities have lost billions, 1 externally funded research has proven to be the most resilient major revenue source for large universities. But we believe that this view, while accurate, may mask a set of concerns that deserves greater scrutiny and perhaps eventual mitigation.

In this paper, we examine some of the budgetary issues facing the scientific research enterprise. Ultimately, it is our belief that, whatever the resiliency of research revenues, there are nevertheless important risks. Most of these risks are concentrated in essential research support and enablement functions, because of how they are funded. The impact of these risks will vary in part by budget models and in part on university research emphasis. 2 Our work here builds on several recently completed Ithaka S+R projects. A landscape review about the impacts of COVID-19 on the research enterprise found substantial questions about the specific impacts on research budgets. 3 An examination of the role and strategic priorities of the senior research officer at major research universities found that these university leaders emphasize the importance of research revenue, fundraising, and budget models in their work. 4 A survey of academic library leaders examined budgetary and strategic decision-making in the fall of 2020. 5 We are also grateful to Jason Owen-Smith, who also examined the impact of COVID-19 on research budgets, and possible paths forward, in 2020. 6 This issue brief provides a summary of the disruptions of 2020 and their implications on the research support and enablement functions going forward. Our goal in this paper is to provide an overview of the key issues facing university budgets and research enablement and support services they fund, to determine whether there are risks emerging for the research enterprise that deserve possible mitigation. 7

Research Funding

It is impossible to examine the dynamics for research support and enablement outside the context of the larger research enterprise revenue and budget situation in the US. In this abbreviated overview, we sketch out some of the macro changes that are of greatest importance.

At the highest level, we expect federal research funding to continue for the foreseeable future. To be sure, it is unclear if federal research funding will grow. The funding added for urgent COVIDrelated work to the NIH especially, but also other federal research funding agencies, during the onset of the pandemic may only be temporary, 8 but it illustrates the importance of the national academic research enterprise as a kind of reserve corps in a scientific emergency that can readily absorb additional resources and prioritize new work. On the other hand, the federal budget has exploded over the past year with various relief bills, and whether increased spending will be maintained, or a new era of austerity will emerge, is beyond our powers of prediction.

Other than the emergency additions to study and combat COVID-19, the federal government's base research funding had been flat for some years. 9 While federal funding represents the largest share of research revenues for the university community, 10 its share of research funding has been decreasing. This has substantial implications for research support and enablement.

The federal government negotiates an indirect cost rate, by university, every few years which it pays to universities in all federally awarded research grants. These indirect costs are intended to cover among other things research enablement and support. Today each university periodically renegotiates its own overhead rate with the government, but many have argued that these rates are insufficient to cover their costs. 11 The Trump administration's early threat to vastly reduce indirect costs on federally funded research, while quickly eliminated, suggested that there could be some precarity in the indirect cost model. 12 Beyond the federal government, other funders pay a lower indirect cost rate or may decline to pay for indirect costs altogether. A small piece of evidence of this pattern was the much trumpeted 2019 decision that several major private foundations would begin to pay the full costs of overhead on their grants. 13 While their effort is to be celebrated, it only serves to illustrate the broader pattern that foundation grants seldom pay the fully loaded costs of the work they support.

Indirect costs are a hugely complex topic that merit an examination of their own, 14 but in brief external research funding does not pay the entire costs of the research enterprise. Rather, other university revenue sources effectively subsidize the research mission. As the Council on Governmental Relations notes, "The university subsidy is a legitimate issue and one that must be addressed honestly and constructively by all stakeholders. The 26 percent administrative cap and sponsor policies and practices that limit F&A reimbursement force universities to fund real, unreimbursed costs through non-federal revenue sources and, therefore, to potentially reduce investments in core missions and infrastructure. Ultimately, this impairs a university's ability to strategically plan and invest in its future research enterprise." 15 Moreover, as the share of funding from non-federal sources has increased, the effective indirect cost rate on the overall research enterprise has declined. This placed university research on shakier ground well before COVID-19 hit other revenue sources such as net tuition, 16 state appropriations, clinical service, and healthcare.

Research Interrupted

The grants awarded to universities to fund scholarly research are typically recognized as revenue only as corresponding expenses are incurred. For instance, in a multi-year grant, a funder might award $1 million in year one, but the grant budget might require the funds to be spent over the course of three years. Even when the full cash award ends up in the university's bank account immediately, accrual accounting mandates that the university cannot recognize this as revenue. The expenses must be incurred in order for the revenue to be recognized. This ordinary principle of university financial operations had profound implications when vast swathes of the research enterprise were interrupted if not entirely shut down during the spring and summer of 2020.

In March 2020, universities in the US paused all but essential research in order to enable social distancing and other pandemic health-related priorities. Many did not restart laboratory research until the summer and some have kept field research on pause even longer. 17

With research disrupted, the default expectation was that universities would not make grantfunded expenditures and would therefore be unable to recognize the associated revenue. While grant funds would remain in the university's bank account, the university would not be able to access the revenue despite incurring other costs, such as salary and benefits for researchers. Without direct expenditures to code to the grant, revenue could not be recognized.

Fortunately, many funding agencies recognized this dynamic and issued policy exceptions, allowing universities to continue recognizing anticipated expenses against existing grants even if the associated research projects could not be advanced as planned. 18 This was an enormous financial relief in the first months of the pandemic.

More recently, many funding agencies have rescinded these policy exceptions. 19 As a result, universities made restarting their research enterprise a major priority, coming up with creative solutions to ensure that the pace of scientific research can continue. Social distancing in laboratories, for example, has required that, in some cases, researchers work in multiple shifts or that they only stay in the lab when they are using its resources for experiments. Through these new guidelines a number of activities, such as conducting paperwork, literature searches, and manuscript writing and editing, are now taking place outside the confines of the lab and often at home. Universities have worked to ensure that the right arrangements are in place to allow the pace of the research enterprise to continue without undue interruption.

One side effect that seems less well understood is how performance outcomes will be measured for grants that have not yielded substantive research progress during this time. Some individuals shifted their focus for several months to writing and publishing, but missing months of primary research will necessarily have an impact on outcomes. How if at all will performance and deliverable expectations be adjusted and taken into account when success is measured for renewals and new grant submissions?

Universities are concerned about the broader implications of this dilemma and have sought federal relief to address the concern. In a series of letters, a group of advocacy organizations for the research university sector urged Congress to provide financial relief to support the research enterprise, declaring that, "Without supplemental funding, federal research agencies will be forced to make difficult decisions between funding the completion of existing research projects or funding new projects-both are important to our nation's scientific competitiveness and economic recovery." 20 It remains unclear if such additional support will be provided and how relief funding and research funding will change under the Biden administration. If there is more relief funding, this will result in yet another temporary expansion of federally funded research.

University Capacity

Short-term boosts in research funding at a sector-wide level, as well as the uncertainty raised earlier about the long-term trajectory of federal research funding, raise questions about universities' capacity to absorb additional research work.

Owen-Smith recently noted that COVID-related funding distributed by the NIH on an urgent basis did not at all follow the typical patterns of overall NIH funding. 21 This analysis suggests that a fairly wide array of research universities showed that they had the research capacity to absorb and utilize a sudden funding increase. More analysis would be needed in order to determine the degree of capacity broadly across the country.

However, there are natural limitations on this capacity in the short term. After all, in order to absorb a substantial increase in research funding, universities would need to provision greater laboratories and hire and enroll additional faculty members, post-docs, and grad students, to say nothing of the research support and enablement services we discuss below.

In the long run, it is possible to build additional laboratories and other research facilities, typically by issuing debt, 22  22 "For decades, colleges and universities largely sold bonds to finance new construction of academic buildings, dorms and sports complexes, and to tackle deferred maintenance. Like many other municipal bonds, these offerings are typically tax-exempt. Some schools issue taxable bonds because they come with fewer restrictions governing use of the funds…. Hoping to address possible shortfalls and take advantage of ultralow rates, universities have flooded the market with debt." Rising yields on higher education bonds can be attributed to the fact that institutions' abilities to carefully navigate the COVID-19 pandemic came into question. Bond issuance came from countless institutions attempting to reduce their fixed costs. For some institutions, they found borrowing money at low rates to be significantly more attractive than risk having to dip into their endowments which could have a possible negative tuition pressures. 23 Similarly, it is possible to hire additional researchers, although many universities are in fact cutting back on the start-up packages that they offer to newly hired researchers to get their research agenda off the ground.

The flip side is that some universities might choose to reduce the size of their research enterprise. Given that, as we noted, many universities believe that their research enterprise is cross-subsidized by other revenue streams, selective cutbacks to reduce the degree of crosssubsidization required could make sense. Of course, if adapted by a sizable number of large research universities, such an approach also would affect the competitiveness of the US research enterprise as a whole.

One mechanism by which this cross-subsidization occurs would be to reduce, if not eliminate, university contributions to "cost-share." 24 Many universities maintain a budget for cost-share, or that portion of a research project's direct costs that are not funded externally but rather covered by the university itself. Many large universities strongly discourage cost sharing, unless the commitment is required by the funder. 25 Still, they typically budget for these funds, sometimes at least in part centrally through the senior research officer and in other cases on a more decentralized basis. As a result of budget cuts, institutions may reduce if not eliminate their budget for cost-share, thereby needing to forgo certain funders and partnerships that they might otherwise have pursued. Over time, this approach could result in a shift in research revenue sourcing if not a selective reduction in research capacity.

Research Support and Enablement

Funding for research support and enablement is perhaps the area of the research enterprise most at risk. These are the absolutely vital functions that make it possible for the university to seek and administer grants, for the university to comply with various regulations, and for the university to support research. While they are sometimes organized or understood as administration and overhead, and while some universities seek to streamline certain elements of this work, little research could take place without them. 26 cost to future generations of students. See Juliet Chung and Melissa Korn, "Bond Boom Comes to America's Colleges and Universities," The Wall Street Journal, December 26, 2020, https://www.wsj.com/articles/bond-boom-comes-to-americas-collegesand-universities-11608978781.

Budgetarily, there are two principal categories of research support and enablement: cost recovery services and overhead services. In the following sub-sections, we examine overhead, some exceptions to the overhead model, and cost recovery services. Budgetary pressures can vary significantly as a result.

Overhead-and Pressures on the General Fund

The more common category of research support and enablement is budgeted out of general funds as overhead against core research activities. This category includes many services that often report up to the senior research officer, such as compliance, proposal development, and research administration. The research library and many research data services are also budgeted as overhead.

Because budgets for these services are derived from university general funds, whenever there is pressure on the general fund, financing for these services is at risk. The general fund is derived from tuition, state appropriations, clinical and healthcare services, indirect costs from sponsored research, and various ancillary services-all of which have been under pressure or in decline as a result of the pandemic. 27 In a responsibility center management institution, these issues are addressed in a more distributed fashion but the overall impacts are expected to be quite similar. 28 The effects on these important research enablement and support services is only beginning to become clear. In the case of the research library, there is already substantial quantitative evidence of budget cuts. 29 In addition, many libraries did not receive a timely budget for the 2020-2021 academic year, and in many cases they are under various forms of expenditure control. Libraries have already reduced spending on collections and made reductions to staffing. There is every reason to anticipate that these cuts will not only continue, but deepen next year. 30 Other research support and enablement services will follow a similar trajectory. In interviews with senior research officers, several reported the "full expectation of needing to make extensive cuts to the research office even though revenues from research activities are steady or growing." 31 As a result, they will need to reduce their services, perhaps by increasing turnaround time for grant submissions, to take one possible example.

Two Exceptions

There are at least two exceptions to the broad pattern of these services being budgeted as overhead. First, especially in the case of the library, while the general fund is almost always the main source of funding, in some institutions it also receives a share of restricted funds from the endowment. This source may be at risk during periods of endowment and market volatility, which was an especially great concern in the spring of 2020 as US public markets dropped steeply in value at the onset of the pandemic. Many endowments ended FY 2020 down, even if they may have recovered since, while endowment spending increased for many institutions. 32 Endowment spending is also often inflexible due to donor restrictions. 33 Still, endowments for research support and enablement are useful in that they can follow a different course than the general funds. It will be interesting to see if more universities attempt to raise endowed funds to support other research enablement and support services beyond the library.

Second, a small number of universities budget for a substantial portion of research support and enablement services on what is essentially a restricted basis. Their model allocates a fixed share of the indirect costs derived from grants to fund these services. This model allows the budget for such services to grow commensurately if the grant-funded research enterprise grows and to shrink naturally if it shrinks. The budgetary independence of this model provides substantial protection for a set of research support and enablement services during a downturn. We are not aware of a case where any portion of the library's budget is covered by such a restricted fund model. 34 variety of restrictions, some research cores are probably less productive. As a result, usage fees for research cores in 2020 were substantially lower than had been anticipated.

This effect on revenue for research cores was substantial enough that a group of advocacy organizations for the university community requested that Congress provide "emergency relief to sustain research support personnel and base operating costs for core research facilities and user-funded research services until such time facilities reopen and research activities return to pre-pandemic activity levels....Relief funds for this purpose would be primarily used to sustain research personnel employment." 35 It is noteworthy that universities focused their request for relief for research support and enablement services on research cores rather than also making the argument that relief was needed for the various services provided out of general funds, such as the library, which are themselves receiving cuts.

Conclusion

Amidst the ongoing pandemic and economic downturn, externally funded research has been the most reliable and resilient major source of revenue for large US universities. But, there are real risks to a variety of research enablement and support services. Universities could benefit from assessing these risks against their research strategy, including their budgetary reliance on research revenues. Some universities may find value in a more comprehensive approach to these risks and their mitigation.

Looking ahead, there is no guarantee for the future, and for now much turns on the plans of the new Biden administration. How will the new administration's stated support for science lead to funding for general basic and applied research? And, will the Biden administration enact further policy exemptions for previously awarded funding or provide further funding for researchers whose work was interrupted in the spring of 2020? Will there be targeted relief for research support and enablement services? Any decrease in available funding levels could impose further strain on university budgets and greater competition among researchers to secure necessary funding, while also reducing the contributions of the national research enterprise as a whole.

which may be complicated right now in light of enrollment and net 20 Mary Sue Coleman et al., "AAU, APLU, AAMC, and ACE Urge Senate to Provide At Least $26 Billion for Research in Next COVID-19 Relief Measure," May 27, 2020, https://www.aau.edu/sites/default/files/AAU-Files/Key-Issues/COVID-19/1ResearchReliefSenateLetter5-27-20Final.pdf; Peter McPherson et al., "AAU, Associations Send Letter to Congressional Leadership Urging Support for the US Research Enterprise," August 3, 2020, https://www.aau.edu/sites/default/files/AAU-Files/Key-Issues/COVID-19/1ResearchReliefSenateLetter5-27-20Final.pdf. 21 Jason Owen-Smith, "The U.S. Academic Research Enterprise (US-ARE): Possible Paths from the Pandemic," Springer Nature, October 21, 2020, 42-44, https://resource-cms.springernature.com/springer-cms/rest/v1/content/18520894/data/v8.
As we were assessing research budget issues, we had in-depth open-ended conversations with several current and former university leaders, including provosts, chief research officers, and CFOs, at some of the largest research universities in the country. We thank Bob Ambach, Matthew Lester, Myron Gutman, Peter Schiffer, Richard Spies, James O'Donnell, Paul Courant, Adrian Hill, and Nick Wigginton for speaking with us and sharing so generously. We thank Kimberly Lutz for comments on an earlier draft of this paper.8 Representative Joe Courtney, "H.R.748 -CARES Act," Pub. L. No. H.R.748, Public Law No: 116-136, 2020, https://www.congress.gov/bill/116th-congress/house-bill/748; National Institutes of Health (NIH), "Support for COVID-19 Research," COVID-19 Research, December 15, 2020, https://commonfund.nih.gov/covid19; National Science Foundation (NSF), "COVID-19 Response Funding Update," Facts, National Science Foundation (NSF), May 2020, https://www.nsf.gov/about/congress/funding%20updates/5.8%20to%205.14%20CARES%20Act%20Update.pdf. 9 See Figure I. National Institute of Health (NIH) Funding, FY1995-FY2021 in the following report: Kavya Seakar, "National Institutes of Health (NIH) Funding: FY1995-FY2021", Congressional Research Service (CRS), May 12, 2020, https://fas.org/sgp/crs/misc/R43341.pdf. 10 "The federal government is the largest funder of academic R&D, providing more than half (53%, or around $42 billion) of total funds in 2018." See figure 5b-5 on page 12 of the following report: Josh Trapani, Michael T. Gibbons, and NCSES, "Academic Research and Development," NSB-2020-2, National Science Board (NSB), Science & Engineering Indicators, NSF, January 15, 2020, https://ncses.nsf.gov/pubs/nsb20202/academic-r-d-in-the-united-states. 11 Jocelyn Kaiser, "NIH Plan to Reduce Overhead Payments Draws Fire," Science, June 2, 2017, https://doi.org/10.1126/science.aan6926.
Andrew Kreighbaum, "Threat to University Research," Inside Higher Ed, April 3, 2017, https://www.insidehighered.com/news/2017/04/03/hhs-secretary-proposes-cutting-reimbursements-fund-university-based-research; Science News Staff, "What's in Trump's 2018 Budget Request for Science?," Science, May 23, 2017, https://doi.org/10.1126/science.aal1224. 13 Maria Di Mento, "Five CEOs of Wealthy Foundations Pledge to Do More to Help Charities Pay Overhead," The Chronicle of Philanthropy, September 4, 2019, https://www.philanthropy.com/article/five-ceos-of-wealthy-foundations-pledge-to-do-more-to-helpcharities-pay-overhead/?cid=gen_sign_in. 14 See Jane Radecki, "University Budget Models and Indirect Costs: A Primer," Ithaka S+R, February 25, 2020, https://doi.org/10.18665/sr.314858. 15 COGR Costing Committee, "Finances of Research Universities," Council on Governmental Relations (COGR), June 19, 2014, https://www.aau.edu/sites/default/files/AAU%20Files/Key%20Issues/Research%20Administration%20%26%20Regulation/Financesof-Research-Universities-An-Updated-Snapshot-from-COGR.pdf. 16 For example, Moody's has forecast "median net tuition revenue is likely to decline 3.3% and 0.9% in fiscal 2021 for private and public universities, respectively, based on our annual tuition survey results. Patrick McCabe et al., "Higher Education -US: Lower Enrollment Due to Coronavirus Impact Will Lead To Weaker Tuition Revenue," Moody's Investors Service, October 28, 2020, https://www.moodys.com/researchdocumentcontentpage.aspx?docid=PBM_1250618.
Jane Radecki and Roger C. Schonfeld, "The Impacts of COVID-19 on the Research Enterprise: A Landscape Review," Ithaka S+R, October 26, 2020, https://doi.org/10.18665/sr.314247. 18 Ibid. 19 Michael Rigas, "OMB M-20-26," Memorandum (Washington, D.C.: Executive Office of the President Office of Management and Budget, June 18, 2020), https://www.whitehouse.gov/wp-content/uploads/2020/06/M-20-26.pdf.
Patrick McCabe et al., "Higher Education -US: Lower Enrollment Due to Coronavirus Impact Will Lead To Weaker Tuition Revenue," Moody's Investors Service, October 28, 2020, https://www.moodys.com/researchdocumentcontentpage.aspx?docid=PBM_1250618. 24 There are primarily three types of cost sharing that can occur on sponsored projects: (1) mandatory cost sharing, (2) voluntary committed cost sharing, and (3) voluntary uncommitted cost sharing. NC State University, "Cost Sharing," Research Administration and Compliance, 2021, https://research.ncsu.edu/administration/compliance/fiscal-compliance/cost-sharing/. 25 For example, see Harvard's cost sharing policy: Harvard University, "Cost Sharing Policy," Office for Sponsored Programs, April 2020, https://osp.finance.harvard.edu/cost-sharing-policy.26  Many of these issues around support and enablement, including the budget models, were explored in Oya Rieger and Roger Schonfeld, "The Senior Research Officer: Experience, Role, Organizational Structure, Strategic Directions, and Challenges," Ithaka S+R, December 1, 2020, https://doi.org/10.18665/sr.314490.
Mary Sue Coleman et al., "AAU, AAMC, APLU, ACE COVID-19 Research Recommendations," April 7, 2020, https://www.aau.edu/sites/default/files/AAU-Files/AAU-AAMC-APLU-ACE%20COVID19%20Research%20Recommendations%204-7-20.pdf.
Cost Recovery ServicesResearch cores, as they are known colloquially, are the instruments and services shared by multiple researchers and sometimes on an institution-wide or even cross-institutional basis that range from microscopes to telescopes and include animal care, nuclear facilities, and more. While the capital costs of acquiring or constructing these facilities is typically borne by the university, the operating costs for research cores, which largely consist of expert personnel, are often funded on a cost recovery basis. When a researcher plans to use a core, the grant to support the project is used to pay the relevant fees. Research cores are therefore to a large degree exempt from the concerns noted above about reductions in general funds. Unfortunately, during the pandemic, research cores have experienced a different budgetary challenge.While research projects were substantially disrupted in spring 2020, there was little prospect of utilizing many research cores. Subsequently, with research restarted, but taking place under a
The Impacts of COVID-19 on the Research Enterprise: A Landscape Review. Jane Radecki, Roger C Schonfeld, 10.18665/sr.314247Ithaka S+R. Jane Radecki and Roger C. Schonfeld, "The Impacts of COVID-19 on the Research Enterprise: A Landscape Review," Ithaka S+R, October 26, 2020, https://doi.org/10.18665/sr.314247.

University Budget Models and Indirect Costs: A Primer. Jane Radecki, 10.18665/sr.314858Ithaka S+R. Jane Radecki, "University Budget Models and Indirect Costs: A Primer," Ithaka S+R, February 25, 2020, https://doi.org/10.18665/sr.314858.

Libraries Brace for Budget Cuts. Lindsay Mckenzie, Inside Higher EdLindsay McKenzie, "Libraries Brace for Budget Cuts," Inside Higher Ed, April 17, 2020, https://www.insidehighered.com/news/2020/04/17/college-librarians-prepare-looming-budget-cuts-and-journal-subscriptions-could- be.

Academic Library Strategy and Budgeting During the COVID-19 Pandemic: Results from the Ithaka S+R US Library Survey 2020. Jennifer Frederick, Christine Wolff-Eisenberg, 10.18665/sr.314507Ithaka S+R. Jennifer Frederick and Christine Wolff-Eisenberg, "Academic Library Strategy and Budgeting During the COVID-19 Pandemic: Results from the Ithaka S+R US Library Survey 2020," Ithaka S+R, December 9, 2020, https://doi.org/10.18665/sr.314507.

The Senior Research Officer: Experience, Role, Organizational Structure, Strategic Directions, and Challenges. Oya Rieger, Roger Schonfeld, 10.18665/sr.314490Ithaka S+R. Oya Rieger and Roger Schonfeld, "The Senior Research Officer: Experience, Role, Organizational Structure, Strategic Directions, and Challenges," Ithaka S+R, December 1, 2020, https://doi.org/10.18665/sr.314490.

College Endowment Spending Rose and Returns Fell as the Pandemic Set In. Audrey Williams, June , The Chronicle of Higher Education. Audrey Williams June, "College Endowment Spending Rose and Returns Fell as the Pandemic Set In," The Chronicle of Higher Education, February 19, 2021, https://www.chronicle.com/article/college-endowment-spending-rose-and-returns-fell-as-the- pandemic-set-in.

College and University Endowments: In the Public Interest?. Sandy Baum, Catherine Bond Hill, Emily Schwartz, 10.18665/sr.307377Ithaka S+R. Sandy Baum, Catherine Bond Hill, and Emily Schwartz, "College and University Endowments: In the Public Interest?," Ithaka S+R, May 22, 2018, 1-45, https://doi.org/10.18665/sr.307377.

The Senior Research Officer: Experience, Role, Organizational Structure, Strategic Directions, and Challenges. See Oya Rieger, Roger Schonfeld, 10.18665/sr.314490Ithaka S+R. See Oya Rieger and Roger Schonfeld, "The Senior Research Officer: Experience, Role, Organizational Structure, Strategic Directions, and Challenges," Ithaka S+R, December 1, 2020, 11-12, https://doi.org/10.18665/sr.314490.


The Open Library System -Re-invented, Implemented and Working

Jens Hofman Hansen
IT, State and University Library
Head of IT, State and University Library
Special Consultant
Victor Albecks Vej 1, Victor Albecks Vej 1DK-8000, DK-8000Århus C, Århus CDenmark, Denmark

Arne Sørensen
IT, State and University Library
Head of IT, State and University Library
Special Consultant
Victor Albecks Vej 1, Victor Albecks Vej 1DK-8000, DK-8000Århus C, Århus CDenmark, Denmark

The Open Library System -Re-invented, Implemented and Working
Liber QuarterLy 20 (3/4), March 2011 -iSSN: 1435-5205. P307-320 http://liber.library.uu.nl/ igitur publishing this work is licensed under a Creative Commons attribution 3.0 unported License Liber Quarterly Volume 20 Issue 3/4 2011 307opennesslibrary systeminnovationbusiness strategy
A highly modularised and open system is described in this paper, and its ability to support the library's strategy. By focusing on a single problem, it is possible to solve it in a qualitatively or quantitatively different way that is dictated by business vision and user needs. This results in a highly innovative library system when seen as a whole.

users find information on the web: they expect a single search field that gives access to all information irrespective of the collection it may originally come from or be in, whether it is physical or digital, whether they are articles, e-books, images or movies. Our existing search interface was anything but a Google-like interface: it had multiple search fields, radio buttons and dropdown menus, several search pages and no real relevancy algorithm at all.

When we accepted the users' search behaviour, we also decided to shift our focus from trying to teach users how to use our search interface into developing a search interface that was able to push information to our users on their premises. Certain information was never discovered by our users even though we knew that it was very valuable to them. Since we could not find a commercial system that was able to present our data in a suitable way for our focused users, the process of developing a simple but powerful search interface started.

Today, the new search technology behind the search interface is just one of many modules in an open library system that has been re-invented in most of its elements. By developing the new search interface as a separate module concentrating only on the search part, we got exactly what we wanted without spending development money on the elements that already worked fine. Underneath the new user interface, we kept the elements of the library system that handle physical material -the acquisition, the cataloguing, and the lending processes. The main principles of our new search interface are:

Integrated Search and Sorting by Relevance

Users do not concern themselves with technicalities such as databases and data sources; first and foremost, they want some relevant resources. This is why we started to search across all the different data sources and to present results for the user in a single search result sorted by relevance. The integrated indexing of the different data sources into one index means that users in most cases are not even aware that the system is doing something completely new and different.

Post-filtering, not Pre-filtering

Much of what the users originally used to specify in the advanced search interface, without being quite able to predict the outcome, we now present within the search results as automatically generated clusters of interesting information. Clusters are also known as navigators or facets and have become quite conventional today -Google now presents navigators in the left-hand menu by default and so do several other widely used search-focused services.

Clusters can be used in searches where the user is trying to find something specific, or in searches where the user does not exactly know what the goal is, i.e., the user is looking for inspiration. Clustering is an example of a feature in a search system that takes the user by the hand and presents relevant suggestions during the search process, instead of imposing the burden of refining the search criteria on the user in the beginning of the search process ( Figure 2).

Extra Information that Adds Value and Meaning

A library's greatest desire is to deliver relevant material of high quality to its users. Therefore, it is unfortunate if our users do not find all the quality material that is available on isolated library-driven websites.

In our new search system, valuable resources from several Danish library websites are shown in situations where these information fragments are most relevant. Since the introduction of the new search system, we have focused on adding value to the presentation of books and other materials. Today, books are presented not only with basic metadata, but often also the book cover, the table of contents, an abstract and a link to an electronic version. This increases the user's ability to identify whether the book is the right one and gives value even before the user has the book in his hand.

With the new search system, we control the user interface completely and it is really just up to our own prioritisation what we want to do with it. On the basis of user studies and trends in user experience, we have been able to implement and experiment with features such as availability shown directly in the search results, 'Did you mean?' spelling suggestions, a resource basket, 'Other users who borrowed this, also borrowed ...' and several other features ( Figure 3).

We believe that our rapid development and radical new design have not only improved our own library business but also inspired vendors and other libraries to move their search user experience forward. We have noticed that

Fig. 3: Today, information about a book is more than just a simple index card: a link to the online edition, an abstract, the table of contents and similar items are all information that enriches the basic data about the book.

features we pioneered have now been incorporated into commercial systems as standard features. As another way of spreading our ideas and giving value to the rest of the world, we have also chosen to open source what we have developed. Today, our search technology is called Summa 1 , and since it is a refinement and further development of the open source search engine library Lucene 2 , we have found it suitable to open source Summa for everyone who wants to download it, use it and perhaps improve it.

The improvement in the user experience seems to be reflected in the number of materials borrowed by our users. As we have improved the interface and search experience in several iterations, we have also seen a steady increase in our lending and download statistics. It is always difficult to say what is actually the cause of the effect. However, we cannot really attribute the positive development to anything but our focused improvements. Anyway it is very motivating to see a rising tendency that stands in contrast to the falling lending figures of many libraries ( Figure 4).

Replacing Important Elements of the Library System

The value of having a modular library system becomes more and more apparent: in 2010 we had to switch to a new library system because the old system (Horizon from SirsiDynix) was being discontinued. Having developed and tuned our own search interface, our demands for a replacement of this part of the system were very clear: we simply needed a system that could handle information about our materials and users behind the scenes. The user search interface was not a parameter at all since we wanted to plug in the new system below our own search interface.

It was actually possible to change the system without our users being able to detect any changes after the implementation. However, since a replacement like this is really essential and almost unavoidably includes downtime, we carried out the change-over during the Christmas season in order to affect as few users as possible.

We have now replaced both the user interface and the back-end of our system, and the work has been done in completely independent processes. The strategic benefit and value have been clear both times: by having a modular library system it is possible to improve individual elements for the exact purpose that we have identified and prioritised -we have not been tied to one vendor that may have a different business and user focus from us.

Significantly Improving Workflows

Another benefit of the open library system is that we have been able to improve other elements of the system and dramatically reduce the need for manual work while at the same time enhancing the user experience and the feeling of receiving great service when using the library.

Since we do not have every journal from every year in electronic format, a significant number of orders for articles are still handled in a traditional way in our library: when users order a specific article, we basically have to find the physical journal in order to be able to deliver the article to the user. Today, this labour-intensive work is changing dramatically thanks to a module of our library system that represents our concept of digitisation-on-demand and reusing already digitised materials.

From Analogue to Digital

Formerly, users ordered an article through our web interface and we received an e-mail with the request. It was a manual process to keep track of the orders and to find the actual articles. When an article was found, it was photocopied and sent to the user's home address if he did not want to come and get it at the library. The former process was actually quite a good service when seen from the user's perspective (except for the slowness and inflexibility of any analogue distribution system), but also a very expensive one when seen from the library's perspective. With this old workflow, there was no digitisation and no recycling of located articles. This also meant that the cost was constant and only rose if the article service got more popular.

Consequently, we looked at our workflow and identified where we could save manual work and better serve the users: by delivering the articles digitally, the users could get the articles by e-mail right after we had processed the order -a clear benefit when seen from a user perspective. But in building a reservoir of scanned articles with metadata, we have also started to reuse the scans and and no longer had to find the same articles again and again in our stacks. After all, some articles are more popular than others, which means that we process a lot of identical orders over time.

We have introduced the system (we call it 'e-copy') and our users now get scanned articles sent by e-mail. Shortly after the introduction, our recycle percentage was 12% of all ordered articles. This may seem low, but it is significant when taking into consideration that this represents more than 5,000 orders that would otherwise be processed manually.

When users enter all the data themselves, orders tend to include typos and at the same time we cannot expect users to type in the ISSN number of the journal they are looking for. The ISSN number is the key to matching users' orders to existing article scans, and since we wanted to increase our recycle percentage we integrated our system with the nationwide service called Bibliotek. dk. 3 Orders from Bibliotek.dk always include an ISSN number, since users can only order an article after they have found the journal with its metadata on the website. This means that we generally get orders that have a very high data quality.

Improving the Recycle Percentage

After we connected our processing system to the orders from Bibliotek.dk, our recycle percentage rose to 33%. With more than 19,000 deliveries handled automatically that would otherwise have to be processed manually, it is pretty obvious that it makes sense to have isolated this part of our library system as a separate, improvable module. It may not be real innovation, but it certainly is an example of massive rationalisation combined with an improvement of the user experience ( Figure 5).  Digitisation also presents problems: we are not allowed to distribute some articles digitally at all because of copyright issues. But we have developed a workflow that still allows us to save time by digitisation: we scan and keep all articles digitally, but the delivery is up to the user: he can come to the library and print the article himself by using his personal login or he can ask for the article to be mailed to him by snail mail for a small fee. We currently have a new agreement underway with the Danish organisation Copy-Dan 4 that distributes compensation to copyright holders. The new deal will cover even more journals and magazines that can be distributed digitally to all citizens.

We have also widened the scope for the system to include orders of TV and radio broadcasts. Orders are processed in the same system as articles. TV and radio material is not yet delivered digitally due to copyright issues. At the moment, we distribute it on burned DVD's. The workflow is basically the same as for articles and we benefit from the workflow support built into the system already.

A Heavy Building Block: One Petabyte 5 of data

As a national library, it becomes really clear that we need an open library system when it comes to preservation and access to the enormous amounts of digital data representing our digital and digitised cultural heritage.

The diversity of our digital data is enormous: we record all Danish TV transmissions, all national radio transmissions, we harvest the entire Danish internet four times a year 6 , we digitise LPs, old wax cylinders with recorded sound, radio news text manuscripts, newspapers and many other materials.

Digitising and preserving such a diversity of data is anything but simple, and it is crucial that the system we use for this task is replaceable with another system. In other words: when choosing or building a system for preserving digital data in these amounts, the first thing you need to get clear is your exit strategy. How do you get data out of the system if it no longer meets your needs? How do you migrate your data if they are no longer usable in their present format because of changes in the hardware or software available to the general public? These are questions that we need to be able to answer and incorporate into the system we use.

When you start looking into what system you need for preserving all your digital data at a library of this size, you soon find out that you need a highly generic system that can contain and preserve basically all types of digital information; also it must scale to enormous amounts of data. We have not been able to find a commercial system which met our requirements; when we were looking for potential systems, we learned that some systems were probably technically suited for the purpose, but that the way data were stored was black-boxed to a great degree, which also immediately disqualified the systems. Transparency is essential when we want to ensure that we can preserve data for the next 100 or 1,000 years.

Consequently, we have developed our own system called DOMS (Digital Object Management System) that preserves very different kinds of data. To give you an impression: it contains about half a million TV transmissions weighing in at nearly half a petabyte of data (500 terabytes). 300 million digitised radio news manuscripts have also been archived -a tremendous amount of valuable information although it does not take up many gigabytes. At the lower end of the data scale you find very small collections of e.g. 10 special tapes of sound that have been digitised for preservation or 500 wax cylinders that are very fragile and can only be played rarely in their physical form but endlessly in their present digitised form.

In total, we currently store about 1 petabyte of data when we combine the data from both our DOMS and our Internet archive. The data are duplicated in three separate archives, which actually brings the amount of data to 3 petabytes.

One System for all Data

The whole concept of DOMS is precisely to have one system for all data. In the past, many small dedicated websites were developed for individual digitisation projects, websites that tended to die after a few years because they were programmed in programming languages that were not security updated any more or run on server software that had similar problems. Most of these websites were built to present the digitised information to the users, not to preserve the data.

By storing all data in the same system, it is possible for us to continuously monitor if data need to be migrated to other formats. We always know what formats our data are actually in and we can react if a format is becoming difficult to read.

This is also part of the reason why our Internet archive is kept separate from our DOMS: in contrast to data we generate by digitising materials ourselves, the Internet is not controlled by us, so other strategies for preserving and monitoring file formats are needed here. Furthermore, the Internet archive today consists of 4.5 billion separate files -this large amount does not really make it feasible to store it in a Fedora Commons 7 system.

Focus on Storage, not on Presentation

DOMS is a module in our library system that is intended to manage our digital objects. The focus is not on presenting them to our users. By keeping the data and our presentation of them in separate systems we make sure that both storage and preservation are in the best possible shape. At the same time we can always use the newest technologies and presentation techniques to disseminate the data (Figure 6).

Building a system like DOMS from scratch would be too much work and the risk of building a system which, due to its specific character, would not survive many years, would be too great. Therefore DOMS has been built on the basis of Fedora Commons, which is an architecture for storing, managing, and accessing digital content in the form of digital objects. Fedora defines a set of abstractions for expressing digital objects, asserting relationships between digital objects, and linking 'behaviours' (i.e., services) to digital objects. Fedora has a much more abstract perspective on data than other systems that define archived material (such as, e.g., Dublin Core). This means that we do not have only one data model, such as those which might originate from descriptions of a book or a CD. Having one single data model tends not to work that well when you start describing items that are really different in nature, such as moving images or various digital sound recordings.

On the other hand, if the stored data can be used in practice, we cannot introduce a new description scheme every time we archive a new object. Consequently, the State and University Library has developed selected highly structured data models -e.g. we have one for sound, one for moving images, etc. This work has also made us one of the twelve core committers to Fedora Commons. Everything we develop is open source so we do not just benefit from the work ourselves but we also spread the results to the rest of the world and anyone who wants to benefit from the developed system.

DOMS is growing bigger but it is built to scale. We have tested it for durability of 200 million objects, which should be enough to cover the next five years of digitisation and preservation in one single instance of our DOMS. Once we have reached this limit, parallelisation could be a possible strategy for scaling up the collection even further.

Another aspect we are working on in order to be able to present information from DOMS smoothly to our users is the handling of rights. Individual data collections have different clearances and copyright issues. Some data are available to all, some are only available for researchers, and again some are available only if you pay a fee.

An Automatically Generated User Interface for DOMS

In order to be able to handle many kinds of data and data models, we designed a generic user interface for DOMS to be used by our staff. This makes it easier for staff who digitize collections to input and enrich data. The interface is generated on the basis of the specific data definition, which enters DOMS. This provides easy data input and data enrichment for the staff who work every day with digitising our collections.

Fig. 1 :
1This simplified model illustrates how we define our library system as a whole. It consists of separate replaceable modules. New modules can be added independently of the existing modules, and each module can be replaced with a new one.

Fig. 2 :
2Clusters, 'Did you mean?', availability, different types of ranking and sorting, a resource basket and other interface features are aspects we now control 100%. Being independent of the library system, we can accommodate what the users need and want with regardless of the update frequency of the traditional library system.

Fig. 4 :
4Loans decreased during the period in which our system was down for a major update. But the number of loans clearly increases year by year.

loans initiated via the search interface

Fig. 5 :
5The recycle percentage seems to have stabilised at 33%, but it may slowly go up as the total number of scanned articles increases.

Fig. 6 :
6Very different media types are digitised and stored in the same system called DOMS. This allows us to focus on long-term digital preservation and separate the presentation of the objects from storage.

Fig. 7 :
7Fig. 7:
Open is the Only Way to GoAll the steps of our journey towards a library system which supports our business needs and our users' information needs, tell us that open systems are nearly always the only way to go. We are constantly working on modularising different elements of our great technological eco-system in order to be able to optimise each part to meet the purpose for which they were built. Some modules are self-developed, some are open sourced, and some are commercial products, so openness comes in different shapes and sizes. But all modules exchange data and functionality so they can be combined and intertwined in various ways. It is also very clear to us that optimising building blocks often is a very innovative process -by focusing on a single problem, it is possible to solve it in a qualitatively or quantitatively different way that is not dictated by anything but our business vision and user needs. Furthermore, simply by combining building blocks in the right way, we bring tremendous value to our users -and that is exactly what we believe the library business is all about. Notes 1 http://www.statsbiblioteket.dk/summa/ 2 http://lucene.apache.org/java/docs/ 3 Means "library.dk". Can be seen at www.bibliotek.dk 4 www.copydan.dk 5 A petabyte equals 1,000 terabytes. 6 http://netarkivet.dk/ 7 http://www.fedora-commons.org/


MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes

Sara Kenyon
Peter Brocklehurst firstname.lastname@example.com
NPEU
Institute of Health Sciences
Old RoadOX3 7LFHeadington, OxfordUK

David Jones
Department of Health Sciences
Queens Medical Centre
University of Leicester
4 Child HealthLE2 7LX, NG7 2UHNottinghamUK, UK

Neil Marlow email@example.com
Alison Salt email@example.com
Great Ormond Street Hospital for Sick Children
Great Ormond StreetWC1N 3JHLondonUK

David Taylor

Address: 1 Reproductive Sciences Section
University of Leicester
LE2 7LXLeicesterUK

MRC ORACLE Children Study. Long term outcomes following prescription of antibiotics to pregnant women with either spontaneous preterm labour or preterm rupture of the membranes
10.1186/1471-2393-8-14BioMed Central Page 1 of 9 (page number not for citation purposes) BMC Pregnancy and Childbirth Open Access Study protocol * Corresponding author
Background:The Medical Research Council (MRC) ORACLE trial evaluated the use of co-amoxiclav 375 mg and/or erythromycin 250 mg in women presenting with preterm rupture of membranes (PROM) ORACLE I or in spontaneous preterm labour (SPL) ORACLE II using a factorial design. The results showed that for women with a singleton baby with PROM the prescription of erythromycin is associated with improvements in short term neonatal outcomes, although co-amoxiclav is associated with prolongation of pregnancy, a significantly higher rate of neonatal necrotising enterocolitis was found in these babies. Prescription of erythromycin is now established practice for women with PROM. For women with SPL antibiotics demonstrated no improvements in short term neonatal outcomes and are not recommended treatment. There is evidence that both these conditions are associated with subclinical infection so perinatal antibiotic administration may reduce the risk of later disabilities, including cerebral palsy, although the risk may be increased through exposure to inflammatory cytokines, so assessment of longer term functional and educational outcomes is appropriate.Methods:The MRC ORACLE Children's Study will follow up UK children at age 7 years born to 4809 women with PROM and the 4266 women with SPL enrolled in the earlier ORACLE trials. We will use a parental questionnaire including validated tools to assess disability and behaviour. We will collect the frequency of specific medical conditions: cerebral palsy, epilepsy, respiratory illness including asthma, diabetes, admission to hospital in last year and other diseases, as reported by parents.National standard test results will be collected to assess educational attainment at Key Stage 1 for children in England.

Background & Rationale

The sequaelae of preterm birth pose a significant public health problem. Children born before 37 weeks gestational age are at increasing risk of major disabilities, such as cerebral palsy, with decreasing gestation [1]. Furthermore, of the preterm children without disability, many will have important behavioural and educational difficulties. The ORACLE Children Study presents a unique opportunity to determine if a simple, inexpensive intervention reduces the long term sequaelae of preterm birth with benefit for individuals and their families.

The ORACLE trial evaluated the prescription of Co-amoxiclav 375 mg and/or erythromycin 250 mg to women either with PROM [2] or in SPL [3]. The trial reported that erythromycin did improve the composite primary outcome (death or major cerebral abnormality on ultrasound prior to discharge or chronic lung disease defined as needing oxygen therapy at 36/40 post conceptual age) in singleton babies born to women after PROM. The prescription of Erythromycin was also associated with improvement in other significant outcomes such as prolongation of pregnancy, reduction in the need for neonatal ventilation, oxygenation and treatment with surfactant, a decrease in oxygen dependence at 28 days of age or older, and fewer positive neonatal blood cultures. Although Co-amoxiclav was associated with prolongation of pregnancy, a significantly higher incidence of neonatal necrotising enterocolitis was found in these babies. In the group of women with SPL the use of neither Co-amoxiclav nor erythromycin were associated with any improvement in neonatal morbidity or mortality.

Following the ORACLE trial antibiotic treatment for preterm, prelabour rupture of the membranes (PROM) may become standard practice and so there will never be another opportunity to undertake this study and provide unbiased and reliable evidence on this subject.

There is increasing evidence that, in addition to preterm birth, perinatal infection is an independent antecedent of other disability, particularly cerebral palsy and chronic lung disease. Therefore, perinatal administration of antibiotics could prevent neurological and respiratory disability by two mechanisms, either by prolonging pregnancy and/or by eliminating infection. In contrast however, it is possible that prolongation of pregnancy may increase rather than decrease the risk of disability by continuing fetal exposure to inflammatory cytokines, which have also been implicated in the genesis of neurological damage [4] and chronic lung disease [5]. Some clinical evidence to support this possibility comes from two observational studies of neurodevelopmental outcome in preterm infants born after PROM which showed a higher risk of cerebral palsy or neurological impairment compared with gestation matched controls [6,7]. In addition, duration of membrane rupture had a direct relationship with the risk of neurological impairment [7].

The cerebral and respiratory benefits reported with erythromycin in women with PROM in the ORACLE trial may have been secondary to (a) prolongation of pregnancy and (b) a reduction of the effects of fetal and neonatal lung infection or inflammation. Supportive evidence for the latter comes from broncho-alveolar lavage fluid studies. Studies of the constituents of broncho alveolar lavage fluid have shown that infants who develop chronic lung disease have higher concentrations of neutrophils [8], proinflammatory cytokines [9,10] and proxy markers of neutrophil recruitment, than those who recover from respiratory distress syndrome [9,11]. There is also evidence that intrauterine lung inflammation is implicated in the genesis of chronic lung disease, since high concentrations of the potent profibrotic agent, transforming growth factor, have been described in the first broncho-alveolar lavage fluid after birth of infants who go on to develop chronic lung disease [5,12]. The MRC ORACLE Children Study provides a unique opportunity to determine whether the reductions in chronic lung disease found at discharge from hospital in the erythromycin group are reflected in a decreased incidence of respiratory disease and the need for therapy at 7 years of age.

Follow-up of the infants of women who presented with SPL is important, even in the absence of an apparent effect of antibiotics from ORACLE II [3] on short term morbidity. Many clinicians and researchers are convinced from observational evidence that a substantial proportion of SPL is caused by sub-clinical infection [13]. If this evidence is indeed correct then differences in childhood neurodevelopment and respiratory function could be detected between children born to women randomised to antibiotics compared with those randomised to placebo even though crude measures of early neurological damage or respiratory disease were no different between the groups during the perinatal period.

Methods/Design

ORACLE was a double blind randomised controlled factorial design trial which evaluated whether giving broad spectrum antibiotics to women in SPL or with PROM improved neonatal mortality and morbidity.

Women were randomised to receive antibiotics and matching placebos 4 times daily for 10 days or until delivery, whichever was sooner. ORACLE tested Co-amoxiclav 375 mg and erythromycin 250 mg singularly and in combination.

This phase of the study -the MRC ORACLE Children Study -will follow-up children of women randomised to ORACLE at 7 years of age to determine whether antibiotics have effects on their development, educational attainment, and the risk of conditions such as cerebral palsy and respiratory illness. The MRC ORACLE Children Study will include the 8942 children born to those women randomised in the UK.

Primary & secondary outcomes

The primary outcome is: 1) the overall level of disability (severe, moderate, mild, none) derived from the Multi-Attribute Health Status (MAHS) classification system.

The secondary outcomes are: 1) number of children with 3 or more abnormal attributes derived from the MAHS classification system 2) degree of function (severe, moderate, mild, none) within the 9 domains of vision, hearing, speech, ambulation, dexterity, emotions, cognition, pain and self care.

3) behaviour (Goodman's strengths and difficulties questionnaire). 4) educational achievement in reading, mathematics and writing at Key Stage 1. Data on both levels and raw scores will be collected.

5) incidence of specific medical conditions:

• cerebral palsy • epilepsy • respiratory illness including asthma • diabetes

• admission to hospital in last year

• other diseases • death -from trial entry to aged 7 years -from initial discharge from hospital to aged 7 years

• covariates -family demographic information (housing status, ethnic group, smoking practice) will be collected.

Inclusion/exclusion criteria Inclusions

• surviving children of mothers recruited to the ORACLE trial • child resident in UK

Exclusions

• recruited outside UK • adopted or fostered children and children who have emigrated Children who have been adopted or fostered will not be followed-up to avoid potential distress to parents and child. Children born in Scotland, Northern Ireland or Wales have different National Tests to England and therefore will not have data collected to assess educational achievement.

Postal parent-report questionnaire

A parental questionnaire will be administered to determine the level of disability (severe, moderate, mild, none). This is based on the Multi-Attribute Health Status (MAHS) Mark II and III [14] classification system developed and widely tested by the Departments of Paediatrics and Clinical Epidemiology and Biostatistics of McMaster University, Canada. The additional domain of behaviour is being assessed using the strengths and difficulties questionnaire developed and validated by Robert Goodman [15]. Additional questions will assess the other health related outcomes. Deaths will be categorised hierarchically using the system below developed by PMG and with the advice of Steve Gould, Consultant Pathologist, John Radcliffe Hospital, Oxford

National Tests

In England we will employ a unique and innovative approach of using the standard National Tests (Key Stage 1) to assess the children's educational ability supported by the Qualifications and Curriculum Authority (QCA). Dfes will provide anonymised data for test level achieved and ethnicity of all children in each treatment group. For those children for whom parental consent is obtained level data will be obtained from the Local Education Authority (LEA) and the scores for each question will be collected from individual schools. Children in Northern Ireland and Wales have different National Tests and no such tests are conducted in Scotland therefore these children will not have data collected to assess educational achievement.

Estimated power of study

A total of 8942 babies survived until the end of data collection in England, Scotland, Wales and Northern Ireland. Of these, 4521 were in the SPL group and 4421 were in the PROM group. Not all of these babies will have survived until age 7 years; assuming an 85% response rate to a parental questionnaire, 3843 responses can be expected from the SPL group and 3758 from the PROM group (7601 in total). Table 1 demonstrates the differences detectable between any two intervention groups for the listed primary measure (e.g. erythromycin vs. erythromycin-placebo) in each of the specified sub-groups (SPL and PROM). The estimates of prevalence of disability are based on data derived using the same instrument (MAHS Mark II) [14] on extremely low birth weight (ELBW) babies compared with a reference group of normal birth weight babies. As the majority of ELBW babies are born less than 28 weeks gestation they will have a higher prevalence of disability than the children included in the MRC ORACLE Children Study. For the measure of '3 or more attributes' affected, an incidence of 28% occurred in the ELBW group compared with 2% in the reference group. As the gestational age of the ORACLE population of children is between these extremes a conservative disability estimate of 5% has been taken as the principal estimate and sensitivity to variation of this value of the power of the study to detect differences is explored in the table. By ranking children into groups by their degree of disability (the number of attributes affected) the power of the study to demonstrate smaller differences will be increased by using tests for trends.

Analyses plan

The primary analysis will comprise comparison of MAHS disability prevalence by allocated treatment group, through fitting of logistic models including terms indicating allocation to Co-amoxiclav/not and to Erythromycin/ not, together with an interaction term. Both HUI2 and HUI3 data will be collected and analysed as they have been designed to complement one another but are based on the same conceptual framework. HUI2 refers to worry and anxiety, HUI3 to happiness versus depression. Similarly while both refer to the degree of severity of pain, HUI2 focuses on the use of analgesia while HUI3 focuses on the disruption of activities. Self-care is only available in HUI2 and dexterity only in HUI3. Sensitivity analyses will include i) logistic modelling of the MAHS level of disability, ii) corresponding models for risk differences, iii) alternative approaches to analysing outcomes from multiple births, and iv) models adjusted for demographic covariates if their balance deteriorates during further follow up, and for other covariates including length of gestation, and year of KS1 assessment and original ORACLE outcomes.

Analyses of secondary outcomes will follow the approach for the primary outcome, appropriately modified where necessary to accommodate continuous or survival measures. Details of the analysis of KS1 data are to be developed in collaboration with colleagues in the agency responsible for collection and interpretation of these data. Explicit allowance for multiplicity of comparisons will be made in interpretation of the results.

Planned subgroup analyses

Comparisons of primary and secondary outcomes will be undertaken for the infants of women with: (1) SPLintact membranes; (2) PROM; (3) multiple & singleton pregnancies; (4) >32 week gestation and < 32 week gestation; (5) > < 28 weeks gestation. Table 1: For each sub-group (PROM or SPL), a response from 3700 babies will allow the following differences to be detected with 80% power:

Outcome

Incidence in erythromycin group Incidence in erythromycin placebo group Relative risk reduction '3 or more attributes affected' 3.1% 5% 38% 5.6% 8% 30% 1.5% 3% 50%

Data collection

The women were aware of the possibility of a Follow-Up Study when they were recruited to ORACLE. We will trace both mother and child through the Office of National Statistics (ONS) and will be informed of the mother or child's death since discharge from hospital to date. We will then send an invitation letter to the address obtained for the woman using the NHS Tracing Service (NSTS). If no response is obtained the child's GP will be contacted to check contact details and ascertain if there is a reason e.g. child is currently in care or non-English speaker etc. Translations of all study materials will be available should they be required and an inexpensive pen will be included with the invitation and information leaflets.

Once we have established contact with the woman and child we will make every effort to maintain this by the use of birthday cards and newsletters (to maintain regular contact) and change of address cards (to facilitate tracking of address changes). We will receive listings from ONS quarterly throughout the study so we are aware of embarkations and deaths are notified immediately. We may consider giving maternity units and GP's surgeries posters and information leaflets so women can contact us directly. We confirm current address using NSTS prior to contact when the child is 7 years old. The Information Leaflet is sent to the parents, and two weeks later a questionnaire. Should no response be obtained this is followed by two letters, a fortnight apart, to the GP to ascertain whether we have the correct address and contact information. Following this confirmation a reminder letter is sent to the parent's/carers the week of the child's 7 th birthday including a ~5 voucher which is sent recorded delivery. Should no response be forthcoming the last reminder is done 3 weeks after that and involves either letter or telephone contact, where a phone number is available.

A consent form for educational outcomes (KS1) is sent to parents in England only. KS1 data is to be collected from either schools or Local Education Authority (LEA).

A thank you card will be sent to parents once the questionnaire has been completed and it is planned to send the results of the follow-up to parents, should they request them, in 2008.

Safety

This study is not actively treating women -it is the follow up of the children. However, clinical care is different for the two groups. It is recommended that women with preterm rupture of the membranes receive erythromycin and women with spontaneous preterm labour are not prescribed antibiotic therapy.

A Data Monitoring Committee (DMC) has been established and will meet annually to consider interim analyses. The Committee will determine if additional interim analyses of trial data should be undertaken. It will consider the data from interim analyses, unblinded if considered appropriate, plus any additional safety issues and relevant information from other sources. In the light of this, and ensuring that ethical considerations are of prime importance, to report (following each DMEC meeting) to the Trial Steering Committee (TSC) and to recommend on the continuation of the study. The DMC will consider any requests for release of interim trial data and to recommend to the TSC on the availability of this and in the event of further funding being required, to provide to the TSC and MRC appropriate information and advice on the data gathered to date that will not jeopardise the integrity of the study.

Publication and dissemination of results

The results will be published in scientific journals. A writing committee will consist of all applicants with Sara Kenyon taking the lead on writing the paper. To safeguard the scientific integrity of the study, data should not be presented in public or submitted for publication without the consent from the Trial Steering Committee (see organisation below)

Organisation and Governance

The protocol and all subsequent amendments received approval from

Discussion

The ORACLE Children Study will provide important information about the health, development and educational attainment of children at 7 years of age whose mothers were exposed to peripartum antibiotics. This information will be important to both parents and clinicians when faced with either preterm ruptured membranes or threatened spontaneous preterm labour.

Figure 1
1Tracing and contact mechanisms. Child in 7 th year Figure 2 Child in 7 th year. KS1 data extraction Figure 3 KS1 data extraction.

Death categorisations 1. Congenital abnormality 2. Cancer/Neoplasia 3. Complications of Prematurity 3a. Chronic lung disease 3b. CLD and CNS 3c. Central Nervous System related to prematurity4. Central Nervous System

5. Infection

6. Miscellaneous
7. Sudden Unexpected Death in Infancy (SUDIs, SIDS and
Unascertained)

Hygiene and Tropical Medicine; Ms Helena McNally, ECMO Trial, NPEU; Professor Martin Whittle, Clinical Co-Director, National Collaborating Centre for Women and Children's Health, London.The DMC membership is Professor Diane Elbourne,
Chair, Professor of Health Care Evaluation, London
School of

West Midlands Multicentre Research Ethics Committee Date of approval April 2002 Reference number MREC/03/7/14. The study will be sponsored by University Hospitals Leicester. The study will be run according to the MRC Good Clinical Practice Guidelines and UK Data Protection requirements. The study will be monitored on a day-to-day basis by the Study Office based at the University of Leicester with the Project Management Group which consists of all the applicants.The study will be overseen by a Trial Steering Committee (TSC) with the following terms of reference: to monitor and supervise the progress of the trial MRC ORACLE Children Study towards its interim and overall objectives; to review at regular intervals relevant information from other sources (eg, other related trials); to consider the recommendations of the DMC; in the light of these to inform the Council and relevant Research Boards on the progress Tracing and contact mechanisms

Publish with Bio Med Central and every scientist can read your work free of charge"BioMed Central will be the most significant development for disseminating the results of biomedical researc h in our lifetime." Sir Paul Nurse, Cancer Research UK Your research papers will be: available free of charge to the entire biomedical community peer reviewed and published immediately upon acceptance cited in PubMed and archived on PubMed Central yours -you keep the copyright Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp BMC Pregnancy and Childbirth 2008, 8:14 http://www.biomedcentral.com/1471-2393/8/14 of the trial; to advise Council on publicity and the presentation of all aspects of the trial. Richard Lilford, Chair, Professor of Clinical Epidemiology, University of Birmingham; Dr Catherine Elliott, MRC Head Office; Professor Richard Cooke, Consultant Neonatologist, Liverpool Women's Hospital; Mr Chris Whetton, Assistant Director, National Foundation for Educational Research; Gill Gyte National Childbirth Trust; Dr Phillippa Russell, Director, National Council for Disabled Children; Julie Cahill, School Improvement Advisor, London.BioMedcentral

Membership

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AcknowledgementsThe study has been approved and is funded by the UK Medical Research Council.Competing interestsThe authors declare that they have no competing interests.Authors' contributionsAll authors contributed to the study design and developed the protocol. SK will led the study and together with DT and PB will contribute knowledge of maternity practice, KP and DJ statistics, NM neonatology and longer term developmental follow-up, and AS Community Paediatrics and long term follow-up.
GP: General Practitioner; HUI: Health Utilities Index; KS1: Key Stage 1; LEA: Local Education Authority; MAHS: Multi Attribute Health Status; MRC: Medical Research Council; NSTS: National Strategic Tracing Service; ONS: Office of National Statistics; ORACLE :Overview of the Role of Antibiotics in the Curtailment of Labour and Early delivery. ELBW: Extremely Low Birth WeightPROM: Preterm Rupture Of the Membranes; QCA: Qualifications and Curriculum Authority; SPL: Spontaneous Preterm LabourELBW: Extremely Low Birth Weight; GP: General Practi- tioner; HUI: Health Utilities Index; KS1: Key Stage 1; LEA: Local Education Authority; MAHS: Multi Attribute Health Status; MRC: Medical Research Council; NSTS: National Strategic Tracing Service; ONS: Office of National Statis- tics; ORACLE :Overview of the Role of Antibiotics in the Curtailment of Labour and Early delivery; PROM: Preterm Rupture Of the Membranes; QCA: Qualifications and Curriculum Authority; SPL: Spontaneous Preterm Labour.

Outcome among surviving very low birthweight infants; a meta analysis. G L Escobar, B Littenberg, D Petitti, Arch Dis Child. 62Escobar GL, Littenberg B, Petitti D: Outcome among surviving very low birthweight infants; a meta analysis. Arch Dis Child 1991, 62:204-211.

Broad-spectrum antibiotics for preterm rupture of the fetal membranes: The ORA-CLE I randomised Trial. S L Kenyon, D J Taylor, W Tarnow-Mordi, Lancet. 357Kenyon SL, Taylor DJ, Tarnow-Mordi W: Broad-spectrum antibi- otics for preterm rupture of the fetal membranes: The ORA- CLE I randomised Trial. Lancet 2001, 357:981-90.

Broad-spectrum antibiotics for spontaneous preterm labour: The ORACLE II randomised Trial. S L Kenyon, D J Taylor, W Tarnow-Mordi, Lancet. 357Kenyon SL, Taylor DJ, Tarnow-Mordi W: Broad-spectrum antibi- otics for spontaneous preterm labour: The ORACLE II ran- domised Trial. Lancet 2001, 357:991-96.

Maternal intrauterine infections, cytokines and brain damage in the preterm new-born. O Dammann, A Leviton, Pedia Res. 42Dammann O, Leviton A: Maternal intrauterine infections, cytokines and brain damage in the preterm new-born. Pedia Res 1997, 42:1-8.

Cytokines in chronic lung disease of prematurity. S Kotecha, Eur J Pediatr. 155Kotecha S: Cytokines in chronic lung disease of prematurity. Eur J Pediatr 1996, 155:514-17.

Case-control study of antenatal and intrapartum risk factors for cerebral palsy in very preterm singleton infants. D Murphy, S Sellers, I Mackenzie, P Yudkin, A M Johnson, Lancet. 346Murphy D, Sellers S, MacKenzie I, Yudkin P, Johnson AM: Case-con- trol study of antenatal and intrapartum risk factors for cere- bral palsy in very preterm singleton infants. Lancet 1995, 346:1449-1453.

Effect of preterm premature rupture of the membranes on neurodevelopmental outcome: Follow-up at two years of age. A Spinillo, E Capuzzo, M Spronati, A Ometto, S Orcesi, E Fazzi, Br J Obstet Gynaecol. 102Spinillo A, Capuzzo E, Spronati M, Ometto A, Orcesi S, Fazzi E: Effect of preterm premature rupture of the membranes on neu- rodevelopmental outcome: Follow-up at two years of age. Br J Obstet Gynaecol 1995, 102:882-887.

Neonatal lung neutrophils and elastase/proteinase inhibitor imbalances. B E Ogden, S A Murphy, G C Saunders, D Patnak, Johnson Td, Am Rev Respir Dis. 130Ogden BE, Murphy SA, Saunders GC, Patnak D, Johnson TD: Neo- natal lung neutrophils and elastase/proteinase inhibitor imbalances. Am Rev Respir Dis 1984, 130:817-21.

Increase in interleukin-8 and soluble intercellular adhesion molecule 1 in bronchoalveolar lavage of premature infants with chronic lung disease. S Kotecha, B Chan, N Azam, M Silverman, R J Shaw, Arch Dis Child. 72Kotecha S, Chan B, Azam N, Silverman M, Shaw RJ: Increase in interleukin-8 and soluble intercellular adhesion molecule 1 in bronchoalveolar lavage of premature infants with chronic lung disease. Arch Dis Child 1995, 72:F90-96.

Increase in interleukin-1 Beta and interleukin-6 in bronchoalveolar lavage fluid obtained from infants with chronic lung disease of prematurity. S Kotecha, L Wilson, A Wangoo, M Silverman, R J Shaw, Pediatr Res. 40Kotecha S, Wilson L, Wangoo A, Silverman M, Shaw RJ: Increase in interleukin-1 Beta and interleukin-6 in bronchoalveolar lav- age fluid obtained from infants with chronic lung disease of prematurity. Pediatr Res 1996, 40:250-56.

Expression of L-selectin and CD11b on the surfaces of neutrophils obtained from babies who develop chronic lung disease of prematurity. S Kotecha, M Silverman, R J Shaw, N Klein, Arch Dis Child. 78Kotecha S, Silverman M, Shaw RJ, Klein N: Expression of L-selectin and CD11b on the surfaces of neutrophils obtained from babies who develop chronic lung disease of prematurity. Arch Dis Child 1998, 78:F143-48.

Increases in the transforming growth factor beta 1 concentration in brochoalveolar lavage fluid obtained from infants with chronic lung disease of prematurity. S Kotecha, A Wangoo, M Silverman, R J Shaw, J Pediatr. 128Kotecha S, Wangoo A, Silverman M, Shaw RJ: Increases in the transforming growth factor beta 1 concentration in brocho- alveolar lavage fluid obtained from infants with chronic lung disease of prematurity. J Pediatr 1996, 128:464-69.

The role of infection in preterm labour and delivery. R Gomez, R Romero, M Mazor, F Ghezzi, C David, B H Yoon, M G Elder, R Romero, Lamont Rf Edinburgh, Preterm labour. Churchill Livingstone1997Gomez R, Romero R, Mazor M, Ghezzi F, David C, Yoon BH: The role of infection in preterm labour and delivery. In Preterm labour Edited by: Elder MG, Romero R, Lamont RF. Edinburgh: Churchill Livingstone; 1997:85-126.

Comprehensive assessment of the health status of extremely low birthweight children at eight years of age: Comparisons with a reference group. S Saigal, P Rosenbaum, B Stoskupf, L Hoult, W Furlong, D Feeny, E Burrows, G Torrance, J Pediatr. 125411Saigal S, Rosenbaum P, Stoskupf B, Hoult L, Furlong W, Feeny D, Bur- rows E, Torrance G: Comprehensive assessment of the health status of extremely low birthweight children at eight years of age: Comparisons with a reference group. J Pediatr 1994, 125:411.

The strengths and difficulties questionnaire: A research note. R Goodman, Journal of Child Psychology and Psychiatry. 38Goodman R: The strengths and difficulties questionnaire: A research note. Journal of Child Psychology and Psychiatry 1997, 38:581-586.