GUILD: GUidance for Information about Linking Data sets

Record linkage of administrative and survey data is increasingly used to generate evidence to inform policy and services. Although a powerful and efficient way of generating new information from existing data sets, errors related to data processing before, during and after linkage can bias results. However, researchers and users of linked data rarely have access to information that can be used to assess these biases or take them into account in analyses. As linked administrative data are increasingly used to provide evidence to guide policy and services, linkage error, which disproportionately affects disadvantaged groups, can undermine evidence for public health. We convened a group of researchers and experts from government data providers to develop guidance about the information that needs to be made available about the data linkage process, by data providers, data linkers, analysts and the researchers who write reports. The guidance goes beyond recommendations for information to be included in research reports. Our aim is to raise awareness of information that may be required at each step of the linkage pathway to improve the transparency, reproducibility, and accuracy of linkage processes, and the validity of analyses and interpretation of results.Keywords epidemiology, health services, management and policy  Writing committee on behalf of a wider team of linkage experts (listed in the Acknowledgements).

# Introduction
Data linkage is increasingly used to bring together electronic records containing information from different sources about an individual, organization or location. Linkage offers a relatively quick and low cost means of capturing information from large administrative data sets for service planning, delivery and evaluation, surveys and censuses, and research. Data linkage centres have been established in many countries, building on early exemplars of linking administrative data for population-based research in the Nordic countries, Manitoba, Western Australia and Scotland (http://www.ipdln. org/data-linkage-centres). For example, the UK government has invested in national networks for health informatics research (http://www.farrinstitute.org/) and in social research using administrative data (https://adrn.ac.uk/).
Research using linked data is fast becoming a powerful source of evidence to drive policy, practice and biomedical and social sciences. [bib_ref] Data linkage: a powerful research tool with potential problems, Bohensky [/bib_ref] For example, the USA recently passed legislation to mandate sharing of administrative and survey data with the US Census Bureau for research for evidencebased policy.However, there is growing evidence that important elements of data processing before, during and after linkage, can introduce error and lead to biased results. [bib_ref] Data linkage: a powerful research tool with potential problems, Bohensky [/bib_ref] The recent RECORD statement and an earlier framework for reporting recommend information relevant to linkage that should be included in reports of research based on routinely collected health data. [bib_ref] Data linkage: a powerful research tool with potential problems, Bohensky [/bib_ref] [bib_ref] The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement, Benchimol [/bib_ref] [bib_ref] Development and validation of reporting guidelines for studies involving data linkage, Bohensky [/bib_ref] In practice, however, such information is rarely available to researchers. Lack of information is partly because different processes along the data linkage pathway are performed by different agencies . Such fragmentation creates barriers to sharing of information about data processing, prevents analyses that take linkage error into account and can limit understanding of the impact of data quality and linkage error on the results of analyses.
The GUILD guidance addresses this lack of understanding by recommending information that could be made available at each step of the data linkage pathway, by data providers, data linkers, analysts and those writing reports. GUILD guidance does not set minimum standards or criteria for information that should be provided nor is it a checklist or protocol. The aim is to set out principles, to raise awareness, and empower data linkers, analysts, researchers and users of evidence to request and use information to assess linkage error and its impact on results. Linkage error is just one of the consequences of poor data quality or missing data. Analysts have a range of methods for dealing with data quality issues, including linkage error, provided they are made aware of the problem.

## Linkage error
Errors in linkage typically occur where there is no unique identifier across different data sets. In the UK, for example, education, health and tax records use different personal identifiers: a pupil ID, National Health Service (NHS) number and National Insurance (NI) number, respectively. Linkage between these data sources, therefore, relies on other common or quasi-identifying characteristics such as name, sex, date of birth and postcode. There is considerable potential for linkage error as some individuals share the same identifying characteristics, identifiers may be entered incorrectly, or different identifiers may be used across data sets (and over time) for the same person. Linkage error occurs in two ways: false-matches are made where two records are linked but do not belong to the same individual, and missed-matches occur when two records that do belong to the same individual fail to link (see Supplementary data, Appendices 1 and 2). 8 Even small amounts of false-or missed-matches can produce substantially biased results, particularly in data belonging to specific sub-groups of the population, for example, young people, ethnic minorities or the homeless. [bib_ref] Effects of record linkage errors on disease registration studies, Brenner [/bib_ref] [bib_ref] Data linkage errors in hospital administrative data when applying a pseudonymisation algorithm..., Hagger-Johnson [/bib_ref] [bib_ref] Utilising identifier error variation in linkage of large administrative data sources, Harron [/bib_ref] Fragmentation of data processing can make it hard for data linkers and analysts to have the information needed to assess or take into account the impact of linkage error on results. It is common practice for data linkers to keep identifiers (e.g. NHS number or date of birth), separate from attributes (such as information on health, finance or education). This 'separation principle' is used to avoid disclosure during the linkage process . The identifying characteristics are used only for linkage, which may be done by a separate agency (or third party). The attribute data are linked for analysis using an artificial identifier that cannot be used to identify individuals in the real-world .
While the separation principle might reduce the risk of identification, it can increase the risk of biased analyses. 14 Linkers and analysts may be unaware of important groups who are disproportionately affected by linkage error if information is not shared between them. For example, when linking mother and baby data to study infant mortality, babies who die in the first day or two of life may be less likely to be linked because their name or NHS number had not been allocated before death. [bib_ref] The reliability of perinatal and neonatal mortality rates: differential under-reporting in linked..., Anthony [/bib_ref] Data linkers will be unaware of this problem as death is an attribute that is not included with the identifiers used for linkage. Unless information on linkage error is shared with the analyst and incorporated into results, mortality rates could be underestimated. Another example is the calculation of readmission rates for monitoring performance of hospitals. Incorrect or missing patient identifiers are likely to lead to underestimated readmission rates: hospitals with poor quality identifiers will appear to perform better. Provided information on data quality indicators associated with missed-matches or falsematches is made available, linkage error can be mitigated by adaptations to the linkage method, analyses or both. [bib_ref] Data linkage errors in hospital administrative data when applying a pseudonymisation algorithm..., Hagger-Johnson [/bib_ref] [bib_ref] Utilising identifier error variation in linkage of large administrative data sources, Harron [/bib_ref] The GUILD guidance highlights elements of the linkage pathway when error can be introduced and recommends information that can be used to assess or account for linkage error without breaching privacy.

## Guidance development
The GUILD guidance was developed by a core group of UK data linkage experts. In March 2015, we held a meeting with eight experts from the Office for National Statistics and from four academic institutions, chosen for their expertise and experience in data linkage across multiple disciplines including social statistics, health care, demography and education. A core group of four experts reviewed previous guidance, reviews of linkage accuracy studies, and other studies reporting sources of bias along the data linkage pathway, [bib_ref] Data linkage: a powerful research tool with potential problems, Bohensky [/bib_ref] [bib_ref] Development and validation of reporting guidelines for studies involving data linkage, Bohensky [/bib_ref] and drafted initial statements, which were revised following discussion at three face-to-face meetings with the UK expert group. The group debated the steps in the linkage pathway that can increase or mitigate linkage error and its impact on results. No formal process was used to achieve consensus. The main item of contention related to the acceptability of statistical disclosure controls that degrade the quality and utility of the data prior to analysis (Supplementary glossary, Appendix S1). [bib_ref] Statistical approaches to protecting confidentiality for microdata and their effects on the..., Reiter [/bib_ref] Drafts of the recommendations were reviewed by a wider team of UK linkage experts in June 2016 (24 UK experts). We also presented the guidance at an international workshop on data linkage in September 2016 and subsequently held a face-to-face meeting of six international and three UK experts to discuss revisions to the guidance (all contributing experts are listed in the acknowledgements).In the next section and in, we propose items of information prioritized by the linkage experts for sharing at each step of the linkage pathway . Such information could be included in reports of analyses using linked data, or as Supplementary data (e.g. online Appendices). [bib_ref] Linking data for mothers and babies in de-identified electronic health data, Harron [/bib_ref] Step 1. Data provision-the generation, processing and quality control of the source data for linkage
The data provider should publish or otherwise share information to explain how the data set was created and maintainedStep 1a, 1b(i-iv)). In some cases, data providers may need to obtain this information from the service that generated the data. The way data are collected, cleaned and standardized can influence the accuracy of the data and any subsequent linkage. [bib_ref] Administrative database research has unique characteristics that can risk biased results, Van Walraven [/bib_ref] Data providers should share information about how unique identifiers (e.g. NHS number, NI Number and driving license number) were generated and validated. Transcription errors, misspellings and missing data in particular can cause false-and missedmatches. [bib_ref] Data linkage errors in hospital administrative data when applying a pseudonymisation algorithm..., Hagger-Johnson [/bib_ref] [bib_ref] Evaluation of record linkage between a large healthcare provider and the Utah..., Duvall [/bib_ref] [bib_ref] Accuracy and completeness of patient pathways: the benefits of national data linkage..., Boyd [/bib_ref] Information about data cleaning rules and the extent of missing data or errors in identifiers can help identify common scenarios that cause linkage error. [bib_ref] Data linkage errors in hospital administrative data when applying a pseudonymisation algorithm..., Hagger-Johnson [/bib_ref] Information should also be provided about any preprocessing of source data sets involving internal linkage of multiple records to the same entity or to remove duplicate recordsStep 1, 1b(iii)). For example, in Hospital Episodes Statistics (HES) for NHS hospital contacts in England, an algorithm links repeated contacts over time for the same patient. [bib_ref] Data linkage errors in hospital administrative data when applying a pseudonymisation algorithm..., Hagger-Johnson [/bib_ref] [bib_ref] Identifying possible false matches in anonymized hospital administrative data without patient identifiers, Hagger-Johnson [/bib_ref] False-matches and missed-matches occurring during this internal linkage can compound subsequent linkage errors when the HES is linked externally to another data set, such as primary care records. [bib_ref] The effect of data cleaning on record linkage quality, Randall [/bib_ref] Provided information is shared about internal linkage errors within one or more of the source data sets, data linkers may be able to develop linkage algorithms that minimize the problem. 14 In addition, information on the rates of false-and missed-matches can be used to adjust results of analyses or to undertake sensitivity analyses.Data providers or data linkers can replace real-world identifiers with artificial identifiers, i.e. numbers or codes that cannot be traced to the individual or unitStep 1, 1b(iv) or
Step 2, 2a(ii)). The aim is to reduce the risk of identification during linkage. A variety of methods can be used, referred to as privacy preserving techniques. [bib_ref] A taxonomy of privacypreserving record linkage techniques, Vatsalan [/bib_ref] For example, the UK Office of National Statistics replaces real-world names and numbers with an artificial identifier after cleaning and standardization of data received from data providers but prior to linkageStep 2, 2a(ii)). This process is irreversible as the artificial identifier cannot be decoded to regenerate the realworld identifiers.Replacement with artificial identifiers prior to linkage is controversial because it makes it difficult to quantify or take into account linkage errors related to certain characteristics, such as names, postcodes or dates. 29 Steps in the data linkage pathway.GUILD guidance information to be shared before, during and after data linkage

## Item
Concept Guidance
Step Overview of data linkage Data linkers should establish systems to improve the quality of linkage studies, for example, by publishing a database detailing the data linkages undertaken with links to publications. The advisory and approvals structure

## Continued
Step 2. Data linkage-bringing together records belonging to the same individual, place or organization
The first part of the guidance about data linkageStep 2, 2a-b) relates to the information that should be shared when undertaking linkage of two or more data sets for a specific study or analysis. Data linkers should describe and justify the identifying characteristics (e.g. name, postcode, sex and ethnicity) used in the linkage algorithm. In addition to the data cleaning and validation undertaken by data providersStep 1b, 2ai), data linkers may undertake further cleaning and validation of identifying characteristics used for linkageStep 2, 2ai). Cleaning the data by removing spaces in postcodes or editing dates by imputing information where there are inconsistencies, makes it more likely that two identifying characteristics will agree. Care must be taken, whilst data cleaning could enable data linkage to capture more true matches, it could also make it more likely that two records will falsely link. [bib_ref] The effect of data cleaning on record linkage quality, Randall [/bib_ref] The rules used to standardize data should, therefore, be reported in detail, because they influence linkage error. [bib_ref] Data linkage errors in hospital administrative data when applying a pseudonymisation algorithm..., Hagger-Johnson [/bib_ref] It is also important to report the proportion of missing data before and after cleaning, and the number of records excluded or changed, for example, because of duplicate records, improbable characteristics (e.g. date of death before birthdate) or not meeting study criteriaStep 2, 2a(i and ii)). Information about methods used to link data should be shared with analysts and where feasible, this information should be published, including details of the linkage algorithmStep 2, 2a(iii)). A common method for data linkage is to first use rule-based matching (e.g. deterministic or exact matching) followed by score-based matching (e.g. probabilistic linkage) to link any remaining records. [bib_ref] Practical introduction to record linkage for injury research, Clark [/bib_ref] Despite evidence that probabilistic linkage produces less biased results than deterministic linkage alone, 31,32 probabilistic linkage is rarely used for linking administrative data in the UK. However, data linkers in Wales (SAIL), Scotland (eDRIS), Australia, the US and Canada, demonstrate that probabilistic linkage is feasible at scale. [bib_ref] Accuracy and completeness of patient pathways: the benefits of national data linkage..., Boyd [/bib_ref] [bib_ref] The SAIL databank: linking multiple health and social care datasets, Lyons [/bib_ref] [bib_ref] Data survey: developing the statistical longitudinal census dataset and identifying its potential..., Zhang [/bib_ref] Data linkers using score-based methods should report how they grouped records that could potentially linkreferred to as blocking.Step 2, 2a(iv)). Blocking means that only those records with some degree of similarity are compared, e.g. only those where date of birth agrees.Blocking aims to reduce processing time, but can cause missed-matches.
The data linker should share record-level information that enables the analyst to take linkage uncertainty into account in analysesStep 2, 2b). This can be done by attaching indicators of match certainty to each comparison pair of matched records. In rule-based linkage, indicators might reflect the step in the algorithm at which the records were linked (e.g. pass-identifier). In score-based linkage, record-level indicators include match-scores (e.g. match weights, probabilities or ranks). The group or block indicator adds information on how uncertainty varies across groups. When score-based linkage is used, information on the optimum threshold for designating links as matches should be shared, and, where possible, a matrix that shows all possible links for each record above the threshold. These record-level indicators can be used to adjust linked data sets, for example by including or excluding links based on the uncertainty of the match as defined by the match-score. [bib_ref] Accuracy of probabilistic linkage using the enhanced matching system for public health..., Aldridge [/bib_ref] Following the production of a linked data set, the data linker should provide a description of linkage accuracy at the aggregate levelStep 2, 2c(i-iv)). This could include a comparison of aggregate counts of age, sex and other attributes, and reports of the uniqueness and independence of identifying characteristics used for linkage. [bib_ref] Evaluating bias due to data linkage error in electronic healthcare records, Harron [/bib_ref] Step 3 Data analyses Data analysts should assess and report on the quality of the linked data used for analyses 3a Account for linkage error Analysts should report how analyses took into account linkage error, including: Data linkers should provide generic information reflecting regular quality assessments of their linkage processesStep 2, 2d-f), where these are large-scale, ongoing linkages (e.g. all hospitalizations and deaths nationally). In this situation, regular comparisons of samples of linked data to a reference data set where true-and false-matches are known, may be sufficient provided information is reported for important subsections of the population (e.g. infants, elderly) for whom linkage accuracy may vary. 14 Measures include precision or positive predictive value (a measure of falsematches), sensitivity/recall (a measure of missed-matches) and the F-measure (Supplementary data, Appendix S2).Data linkers should publish their methods for disclosure control of linked data before transmission of linked data to the analyst. For example, data linkers sometimes require grouping of detailed values into broader groupings (e.g. changing exact ages to age bands), suppression of outlying values, or addition of random noise to minimize disclosure risksStep 2, 2e). [bib_ref] Statistical approaches to protecting confidentiality for microdata and their effects on the..., Reiter [/bib_ref] [bib_ref] Probabilistic record linkage for disclosure risk assessment, Shlomo [/bib_ref] Making information about the linkage processes publicly available can help to develop rigorous methods throughout the data linkage pathway. Data linkers can support transparency, quality and reproducibility of studies and encourage collective learning about linkage error by publishing details of linkages undertaken with links to subsequent study reportsStep 2, 2f).
[formula] 3a(i) - [/formula]
Step 3. Analyses of the linked data-taking account of linkage error So far, the guidance has focused on providing the data analyst with the information they need to conduct analyses that take into account sources of error before, during and after linkage, Steps 1-3). The analyst should report any evaluation of linkage accuracy against a reference standard and how they used this information in their analyses in meta-data or research reports (see Supplementary data, Appendix 3).
The analyst should report use of record-level indicators of linkage uncertainty (e.g. match weights) in the analyses, for example, whether varying the match score changed the results of analysesStep 3, 3a(ii-iii)). [bib_ref] Utilising identifier error variation in linkage of large administrative data sources, Harron [/bib_ref] [bib_ref] Accuracy of probabilistic linkage using the enhanced matching system for public health..., Aldridge [/bib_ref] An alternative approach is to use match weights for all possible links to select the correct value for the variable of interest (known as prior informed imputation). [bib_ref] The analysis of record-linked data using multiple imputation with data value priors, Goldstein [/bib_ref] This method avoids errors that could be incurred by accepting the wrong record as a link. If the analyst does not have record-level indicators of the linkage process, they can adjust for linkage error based on comparisons of the linked data with the unlinked source populations or through external comparisons with expected ratesStep 3, 3a(i)).
Step 4. Reporting the results of analyses of linked data Reports of studies using linked data should, where possible, include information on items in Steps 1-3. Information should be prioritized to enable users of studies (e.g. journal editors, researchers, policy makers, data providers and linkers and the public) to understand the extent of linkage error and the potential impact on results and reproducibility of analyses.Research reports should continue to use the STROBE guidance, supplemented by the 13-item RECORD statement for specific items of information for observational studies using administrative data, including the four items about data linkage (Supplementary data, Appendix 3). [bib_ref] The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement, Benchimol [/bib_ref] When publishing results, statistical disclosure controls may prevent publication of potentially disclosive information, such as minimum-maximum ranges and small cell sizes, which could provide insights into linkage error. In these circumstances, potentially disclosive results may need to be restricted to approved users. [bib_ref] Error adjustments for file linking methods using encrypted unique client identifier (eUCI)..., Gutman [/bib_ref] 

# Discussion
Main findings of this study GUILD aims to improve the quality of data processing, linkage, analyses and research reports by raising awareness about detailed information that could be shared at each step of the linkage pathway. The guidance also aims to highlight the responsibilities of data providers, linkers and analysts, not just report writers, to make this information available.

## What is already known?
Linkage error can contribute to selection bias or information bias or both, depending on the study design and the way in which linkage is used to generate the variables used in analyses. The STROBE and RECORD reporting guidelines make recommendations about information that should be included in research reports of observational studies based on electronic health data sets but do not provide guidance on potential sources of linkage error. [bib_ref] The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement, Benchimol [/bib_ref] [bib_ref] The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines..., Von Elm [/bib_ref] What this study adds GUILD highlights the choices and decisions made during data processing that affect linkage error and hence the results of analyses. Sharing information along the data linkage pathway could improve the transparency and reproducibility of research, promote the use of improved methods to address linkage error, and improve the interpretation of studies based on linked data.

## Limitations of the study
Development of the GUILD guidance involved iterative discussions with UK and international linkage experts but did not use formal consensus methods. The scope of GUILD is broad, involving different processes and a variety of agencies, analysts and methods. Further methodological research can inform updates to this guidance and help to prioritize key items of information that should be made available. There is also a need to develop appropriate formats (e.g. meta-data and data sharing agreements) for sharing information about sources of linkage error while preserving the privacy of data entities or individuals.
Linked administrative data are a powerful resource, which is increasingly used to underpin policy, organization of services and research. Transparency throughout the linkage pathway is important to ensure that the validity of this resource is fit-for-purpose.

## Supplementary data
Supplementary data are available at Journal of Public Health online.