The need to improve reporting of routinely collected dermatology data for patient benefit

The increasing availability of routinely collected health data sources including electronic medical records, administrative data and registries, represents a major opportunity for efficient dermatology research. Understanding the epidemiology of skin diseases is critically important for a variety of reasons. Firstly, epidemiology can highlight the burden of diseases, including changes in patterns of skin diseases over time and place. These observations can provide aetiological clues to, for example, the rapidly increasing prevalence of eczema in developing countries. Routinely collected health data can also help with both hypothesis generation and testing, and can provide signals and discoveries to inform translational research and trials. Randomized trials have provided excellent data about the efficacy of therapies in skin diseases, but are often challenged by logistics including time, cost and limited sample sizes, and their generalizability may be limited by strict inclusion criteria. Routine data may be a useful tool to bridge the gap between need and available resources and to provide key evidence about the real-world effectiveness of therapies for skin diseases, including populations that might be excluded from clinical trials. For example, routine data could be used to undertake pharmacoepidemiology studies such as phase IV post-marketing studies of biologics for risk and benefit or to identify adherence to biologic therapies. Data on rare but potentially serious adverse events typically emerge only from large databases of drug use in the population rather than trials. Indeed, the informatics revolution and the major opportunities from increasing access to healthcare databases have been highlighted in the recent BJD position statement as a major factor contributing to the growth of epidemiology of skin. Despite their vast potential, the use of routinely collected health data for research also brings new challenges for researchers, editors, and those making decisions about healthcare policy. Routinely collected healthcare data by definition are not captured to specifically answer an a priori research question. These data include a broad spectrum of resources captured for a wide variety of reasons, including clinical care of patients, administrative and billing purposes. Understanding the strengths, limitations and resulting biases associated with using individual data sources is challenging. The reporting of research undertaken using routine data is poor, with two recent systematic reviews identifying poor reporting of validation studies from routine health data; inadequate reporting compounds the challenge for readers of research and those using research to inform health policy decisions. Poor reporting of research is a major source of research waste, as it can reduce the usefulness of research findings, lead to unnecessary replication, and lead to conclusions that may not be valid. Reporting guidelines are useful to ensure transparency and to inform readers of what was planned, what was done and what was found in the research. Reporting guideline initiatives, such as the CONSORT initiative, have led to an improvement in research reporting. The guidelines for STrengthening of Reporting of OBservational studies in Epidemiology (STROBE) have been a welcome development to improve the reporting of observational studies such as case–control and cohort studies and provide a checklist of the minimum items that should be reported. STROBE has been implemented by the BJD since its publication in 2008. The majority of research undertaken using routine data is observational in design; however, there are specific features relating to the use of routine data for research that are not currently addressed by STROBE. These include the use of codes and algorithms to identify participants, exposures and outcomes, reporting of linkage characteristics, when linking more than one database and the characteristics of databases. The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) initiative is an international collaborative effort involving more than 100 stakeholders, which has developed an extension to the STROBE guidelines to improve the reporting of research using routine health data. The RECORD guidelines were created using methods proposed by members of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network. Briefly, following a wide recruitment of stakeholders representing researchers, editors, pharmaceutical industry and policy-makers, a series of modified eDelphi surveys were undertaken to identify proposed themes that stakeholders considered essential to the reporting of research using routine data. Survey findings and input from all stakeholders using a message board informed the creation of the record checklist and explanatory document. The final RECORD checklist (Table 1) and explanatory document are available online at record-statement.org or in PLoS Medicine. The RECORD steering group welcomes comments and recommendations from any interested parties. The RECORD statement focuses on observational studies, as an extension to STROBE. However, increasingly, routine data are being used for research that is not observational in nature, including pragmatic randomized controlled trials, where they have the potential for great efficiency and inclusiveness. In future, the RECORD will be modified to encompass interventional studies and other research designs. The RECORD steering group are delighted that the BJD has decided to endorse the RECORD statement and to implement its use for authors submitting relevant manuscripts. The RECORD steering group look forward to working with the BJD to help implement the checklist. Endorsement of the checklist may not be sufficient to improve research reporting – the implementation of the RECORD through rigorous evaluation and education of peer reviewers, authors and editors is also essential. The RECORD steering committee is currently planning prospective assessment of the impact of adopting the RECORD on the quality and completeness of submitted reports using routine health data. Improving the quality of reporting of dermatology research using routinely collected health data and reducing research waste will ultimately help patients with skin disease.

The increasing availability of routinely collected health data sources including electronic medical records, administrative data and registries, represents a major opportunity for efficient dermatology research. Understanding the epidemiology of skin diseases is critically important for a variety of reasons. Firstly, epidemiology can highlight the burden of diseases, including changes in patterns of skin diseases over time and place. These observations can provide aetiological clues to, for example, the rapidly increasing prevalence of eczema in developing countries. 1 Routinely collected health data can also help with both hypothesis generation and testing, and can provide signals and discoveries to inform translational research and trials. Randomized trials have provided excellent data about the efficacy of therapies in skin diseases, but are often challenged by logistics including time, cost and limited sample sizes, and their generalizability may be limited by strict inclusion criteria. 2 Routine data may be a useful tool to bridge the gap between need and available resources and to provide key evidence about the real-world effectiveness of therapies for skin diseases, including populations that might be excluded from clinical trials. For example, routine data could be used to undertake pharmacoepidemiology studies such as phase IV post-marketing studies of biologics for risk and benefit or to identify adherence to biologic therapies. Data on rare but potentially serious adverse events typically emerge only from large databases of drug use in the population rather than trials. Indeed, the informatics revolution and the major opportunities from increasing access to healthcare databases have been highlighted in the recent BJD position statement as a major factor contributing to the growth of epidemiology of skin. 3 Despite their vast potential, the use of routinely collected health data for research also brings new challenges for researchers, editors, and those making decisions about healthcare policy. Routinely collected healthcare data by definition are not captured to specifically answer an a priori research question. These data include a broad spectrum of resources captured for a wide variety of reasons, including clinical care of patients, administrative and billing purposes. Understanding the strengths, limitations and resulting biases associated with using individual data sources is challenging. The reporting of research undertaken using routine data is poor, with two recent systematic reviews identifying poor reporting of validation studies from routine health data; inadequate reporting compounds the challenge for readers of research and those using research to inform health policy decisions. 4 Poor reporting of research is a major source of research waste, as it can reduce the usefulness of research findings, lead to unnecessary replication, and lead to conclusions that may not be valid. 5 Reporting guidelines are useful to ensure transparency and to inform readers of what was planned, what was done and what was found in the research. Reporting guideline initiatives, such as the CONSORT initiative, have led to an improvement in research reporting. 6,7 The guidelines for STrengthening of Reporting of OBservational studies in Epidemiology (STROBE) have been a welcome development to improve the reporting of observational studies such as case-control and cohort studies and provide a checklist of the minimum items that should be reported. 8 STROBE has been implemented by the BJD since its publication in 2008.
The majority of research undertaken using routine data is observational in design; however, there are specific features relating to the use of routine data for research that are not currently addressed by STROBE. These include the use of codes and algorithms to identify participants, exposures and outcomes, reporting of linkage characteristics, when linking more than one database and the characteristics of databases.
The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) initiative is an international collaborative effort involving more than 100 stakeholders, which has developed an extension to the STROBE guidelines to improve the reporting of research using routine health data. The RECORD guidelines were created using methods proposed by members of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network. 9 Briefly, following a wide recruitment of stakeholders representing researchers, editors, pharmaceutical industry and policy-makers, a series of modified eDelphi surveys were undertaken to identify proposed themes that stakeholders considered essential to the reporting of research using routine data. Survey findings and input from all stakeholders using a message board informed the creation of the record checklist and explanatory document. 10 The final RECORD checklist (Table 1) and explanatory document are available online at record-statement.org or in PLoS Medicine. 11 The RECORD steering group welcomes comments and recommendations from any interested parties.
The RECORD statement focuses on observational studies, as an extension to STROBE. However, increasingly, routine data are being used for research that is not observational in nature, including pragmatic randomized controlled trials, where they have the potential for great efficiency and inclusiveness. 12 In future, the RECORD will be modified to encompass interventional studies and other research designs.
The RECORD steering group are delighted that the BJD has decided to endorse the RECORD statement and to implement its use for authors submitting relevant manuscripts. The RECORD steering group look forward to working with the BJD to help implement the checklist. Endorsement of the checklist may not be sufficient to improve research reportingthe implementation of the RECORD through rigorous evaluation and education of peer reviewers, authors and editors is also essential. The RECORD steering committee is currently planning prospective assessment of the impact of adopting the RECORD on the quality and completeness of submitted reports using routine health data. Improving the quality of reporting of dermatology research using routinely collected health data and reducing research waste will ultimately help patients with skin disease.