The Birmingham COPD Cohort study

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the University of Birmingham to determine whether or not it will seek permission from NHS Digital to retain the data under this Agreement for a longer period. Should the University of Birmingham wish to retain the data for a longer period, the University of Birmingham must submit a subsequent application to extend this Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The following provides background information on the purpose of the original study:

The Birmingham COPD Cohort study is a three-year longitudinal study of primary care COPD patients; a substantial work package within a NIHR-funded research programme grant (ref: RP-PG-0109-10061, 01/01/2011 – 31/12/2016). Chronic Obstructive Pulmonary Disease (COPD) is an important health problem, accounting for significant health service and societal costs. However the natural history and factors affecting prognosis are poorly understood and interventions for early disease are limited. There is also considerable under-diagnosis, resulting in potential unmet need.

A better understanding of factors that determine prognosis, particularly those that are modifiable, is essential for informing future interventions. In addition, a better understanding of prognosis helps inform patient management decisions, and facilitates doctor patient relationships. A number of prognostic indices have been developed and are currently used, which typically aim to predict either mortality or hospitalisation. The BLISS research team wishes to process data relating to hospitalisation and mortality in order to generate the prognostic indices for the COPD Cohort Study participants. These data are unavailable from other sources and will be more accurate and complete than self-reported information.

The Birmingham COPD Cohort study uses all-cause hospitalisation within three years as the primary outcome, with secondary outcomes including number and duration of hospitalisations, respiratory hospitalisations, healthcare costs and mortality.

COPD patients are at high risk of hospitalisations due to exacerbations, when their symptoms worsen and cannot be adequately controlled at home. However, due to the number of comorbidities common in this patient group (e.g. heart disease) and the complex interactions between them, the cause of hospitalisation is often miscoded. If the data requested were limited to admissions coded as being respiratory-related, a substantial proportion of admissions would be missed, therefore underrepresenting the burden on hospitals associated with COPD. Only age-appropriate variables (e.g. not paediatric or maternity) are requested, hence adhering to data minimisation. The data fields requested were critically reviewed in the initial application leading to a reduction in the number of fields requested.

For the above reasons, the study protocol was written with all-cause hospitalisations as the primary outcome. The study is funded by the NIHR to answer specific research questions; primarily the prediction of all-cause hospitalisation within this patient group. A power calculation was used to determine the number of recruited patients needed to answer the question, and result in statistically significant findings. Now the study is nearing completion the primary outcome cannot be changed, as this would contravene the study protocol and the funding agreement with the NIHR.

The study is also funded to collect and analyse secondary outcomes including A&E admissions and outpatient appointments, to assess how patients’ lung health affects healthcare utilisation overall.

The above explains why HES A&E attendance, outpatients, admitted patient care and critical care products are requested. Data covering 2007/08 to 2015/16 (and 2008/09 to 2015/16 for Critical Care) is required across all HES datasets for this purpose. In addition, Civil Registration Mortality data is also required of which will be restricted to the cohort participants with a HES entry between 01/04/2012 to 31/03/2016. Full Date of Death is substituted for a derived Month and Year Date of Death.

The University of Birmingham is the data controller and also processes the data for this study. No other organisations process the data for this purpose.

The long-term follow-up of all eligible patients is in the interests of the health of the public. The University of Birmingham can therefore lawfully process the data under GDPR Articles 6(1)(e) (processing is necessary for the performance of a task in the public interest) and 9(2)(j) (processing is necessary for… scientific or historical research purposes). Considerable resources would be required for the primary care sector to adopt methods used in the Birmingham COPD Cohort study to diagnose COPD patients earlier. If long-term analysis demonstrates that hospital usage and mortality is not reduced through earlier COPD diagnosis, it would indicate that NHS resources could be better spent in other ways. Evidence from the current study will be produced as a final report for the National Institute for Health Research as well as peer-reviewed academic papers, hence disseminating evidence to policy makers and academic researchers.

This Agreement permits the secure retention of the data only and no other processing.

No new outputs will be produced under this Data Sharing Agreement.

The University of Birmingham submitted the final report to the funders (NIHR) in June 2020, which provided a narrative on the methodology, the results, the conclusions and recommendations. The Cohort study developed a new prognostic model, including 9 variables, which performs well in predicting hospital admissions among people with COPD. This model can be used to guide and to prioritise patient management.

The findings of the overall study and the results of interim analyses during the study period will also be and, in the case of some interim findings, have been be disseminated via academic peer-reviewed papers and conference presentations. Publications and presentations will continue beyond the current study period. The main paper regarding the prognostic model is being submitted for publication shortly, and we hope it will be published by the end of 2020.

Outputs present group-level data only (e.g. proportion of patients with specified characteristics/outcomes). All data included in outputs are aggregated with small numbers suppressed in line with the HES Analysis Guide. The funder’s report is solely for the purposes of the funding body. All academic publications will be ‘open-access’ (available to members of the public without cost) and will be available on the websites of the publishing journal as well as through the study website (www.birmingham.ac.uk/bliss).

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

This Data Sharing Agreement permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the University of Birmingham to determine whether or not it will seek permission from NHS Digital to retain the data under this Agreement for a longer period. Should the University of Birmingham wish to retain the data for a longer period, the University of Birmingham must submit a subsequent application to extend this Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The following provides background information on the purpose of the original study:

The Birmingham COPD Cohort study is a three-year longitudinal study of primary care COPD patients; a substantial work package within a NIHR-funded research programme grant (ref: RP-PG-0109-10061, 01/01/2011 – 31/12/2016). Chronic Obstructive Pulmonary Disease (COPD) is an important health problem, accounting for significant health service and societal costs. However the natural history and factors affecting prognosis are poorly understood and interventions for early disease are limited. There is also considerable under-diagnosis, resulting in potential unmet need.

A better understanding of factors that determine prognosis, particularly those that are modifiable, is essential for informing future interventions. In addition, a better understanding of prognosis helps inform patient management decisions, and facilitates doctor patient relationships. A number of prognostic indices have been developed and are currently used, which typically aim to predict either mortality or hospitalisation. The BLISS research team wishes to process data relating to hospitalisation and mortality in order to generate the prognostic indices for the COPD Cohort Study participants. These data are unavailable from other sources and will be more accurate and complete than self-reported information.

The Birmingham COPD Cohort study uses all-cause hospitalisation within three years as the primary outcome, with secondary outcomes including number and duration of hospitalisations, respiratory hospitalisations, healthcare costs and mortality.

COPD patients are at high risk of hospitalisations due to exacerbations, when their symptoms worsen and cannot be adequately controlled at home. However, due to the number of comorbidities common in this patient group (e.g. heart disease) and the complex interactions between them, the cause of hospitalisation is often miscoded. If the data requested were limited to admissions coded as being respiratory-related, a substantial proportion of admissions would be missed, therefore underrepresenting the burden on hospitals associated with COPD. Only age-appropriate variables (e.g. not paediatric or maternity) are requested, hence adhering to data minimisation. The data fields requested were critically reviewed in the initial application leading to a reduction in the number of fields requested.

For the above reasons, the study protocol was written with all-cause hospitalisations as the primary outcome. The study is funded by the NIHR to answer specific research questions; primarily the prediction of all-cause hospitalisation within this patient group. A power calculation was used to determine the number of recruited patients needed to answer the question, and result in statistically significant findings. Now the study is nearing completion the primary outcome cannot be changed, as this would contravene the study protocol and the funding agreement with the NIHR.

The study is also funded to collect and analyse secondary outcomes including A&E admissions and outpatient appointments, to assess how patients’ lung health affects healthcare utilisation overall.

The above explains why HES A&E attendance, outpatients, admitted patient care and critical care products are requested. Data covering 2007/08 to 2015/16 (and 2008/09 to 2015/16 for Critical Care) is required across all HES datasets for this purpose. In addition, Civil Registration Mortality data is also required of which will be restricted to the cohort participants with a HES entry between 01/04/2012 to 31/03/2016. Full Date of Death is substituted for a derived Month and Year Date of Death.

The University of Birmingham is the data controller and also processes the data for this study. No other organisations process the data for this purpose.

The long-term follow-up of all eligible patients is in the interests of the health of the public. The University of Birmingham can therefore lawfully process the data under GDPR Articles 6(1)(e) (processing is necessary for the performance of a task in the public interest) and 9(2)(j) (processing is necessary for… scientific or historical research purposes). Considerable resources would be required for the primary care sector to adopt methods used in the Birmingham COPD Cohort study to diagnose COPD patients earlier. If long-term analysis demonstrates that hospital usage and mortality is not reduced through earlier COPD diagnosis, it would indicate that NHS resources could be better spent in other ways. Evidence from the current study will be produced as a final report for the National Institute for Health Research as well as peer-reviewed academic papers, hence disseminating evidence to policy makers and academic researchers.

This Agreement permits the secure retention of the data only and no other processing.

No new outputs will be produced under this Data Sharing Agreement.

The University of Birmingham submitted the final report to the funders (NIHR) in June 2020, which provided a narrative on the methodology, the results, the conclusions and recommendations. The Cohort study developed a new prognostic model, including 9 variables, which performs well in predicting hospital admissions among people with COPD. This model can be used to guide and to prioritise patient management.

The findings of the overall study and the results of interim analyses during the study period will also be and, in the case of some interim findings, have been be disseminated via academic peer-reviewed papers and conference presentations. Publications and presentations will continue beyond the current study period. The main paper regarding the prognostic model is being submitted for publication shortly, and we hope it will be published by the end of 2020.

Outputs present group-level data only (e.g. proportion of patients with specified characteristics/outcomes). All data included in outputs are aggregated with small numbers suppressed in line with the HES Analysis Guide. The funder’s report is solely for the purposes of the funding body. All academic publications will be ‘open-access’ (available to members of the public without cost) and will be available on the websites of the publishing journal as well as through the study website (www.birmingham.ac.uk/bliss).

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

The Birmingham COPD Cohort study is a three-year longitudinal study of primary care COPD patients; a substantial work package within a NIHR-funded research programme grant (ref: RP-PG-0109-10061, 01/01/2011 – 31/12/2016). Chronic Obstructive Pulmonary Disease (COPD) is an important health problem, accounting for significant health service and societal costs. However the natural history and factors affecting prognosis are poorly understood and interventions for early disease are limited. There is also considerable under-diagnosis, resulting in potential unmet need.

A better understanding of factors that determine prognosis, particularly those that are modifiable, is essential for informing future interventions. In addition, a better understanding of prognosis helps inform patient management decisions, and facilitates doctor patient relationships. A number of prognostic indices have been developed and are currently used, which typically aim to predict either mortality or hospitalisation. The BLISS research team wishes to process data relating to hospitalisation and mortality in order to generate the prognostic indices for the COPD Cohort Study participants. These data are unavailable from other sources and will be more accurate and complete than self-reported information.

The Birmingham COPD Cohort study uses all-cause hospitalisation within three years as the primary outcome, with secondary outcomes including number and duration of hospitalisations, respiratory hospitalisations, healthcare costs and mortality.

COPD patients are at high risk of hospitalisations due to exacerbations, when their symptoms worsen and cannot be adequately controlled at home. However, due to the number of comorbidities common in this patient group (e.g. heart disease) and the complex interactions between them, the cause of hospitalisation is often miscoded. If the data requested were limited to admissions coded as being respiratory-related, a substantial proportion of admissions would be missed, therefore underrepresenting the burden on hospitals associated with COPD. Only age-appropriate variables (e.g. not paediatric or maternity) are requested, hence adhering to data minimisation. The data fields requested were critically reviewed in the initial application leading to a reduction in the number of fields requested.

For the above reasons, the study protocol was written with all-cause hospitalisations as the primary outcome. The study is funded by the NIHR to answer specific research questions; primarily the prediction of all-cause hospitalisation within this patient group. A power calculation was used to determine the number of recruited patients needed to answer the question, and result in statistically significant findings. Now the study is nearing completion the primary outcome cannot be changed, as this would contravene the study protocol and the funding agreement with the NIHR.

The study is also funded to collect and analyse secondary outcomes including A&E admissions and outpatient appointments, to assess how patients’ lung health affects healthcare utilisation overall.

The above explains why HES A&E attendance, outpatients, admitted patient care and critical care products are requested. Data covering 2007/08 to 2015/16 (and 2008/09 to 2015/16 for Critical Care) is required across all HES datasets for this purpose. In addition, Civil Registration Mortality data is also required of which will be restricted to the cohort participants with a HES entry between 01/04/2012 to 31/03/2016. Full Date of Death is substituted for a derived Month and Year Date of Death.

The University of Birmingham is the data controller and also processes the data for this study. No other organisations process the data for this purpose.

The long-term follow-up of all eligible patients is in the interests of the health of the public. The University of Birmingham can therefore lawfully process the data under GDPR Articles 6(1)(e) (processing is necessary for the performance of a task in the public interest) and 9(2)(j) (processing is necessary for… scientific or historical research purposes). Considerable resources would be required for the primary care sector to adopt methods used in the Birmingham COPD Cohort study to diagnose COPD patients earlier. If long-term analysis demonstrates that hospital usage and mortality is not reduced through earlier COPD diagnosis, it would indicate that NHS resources could be better spent in other ways. Evidence from the current study will be produced as a final report for the National Institute for Health Research as well as peer-reviewed academic papers, hence disseminating evidence to policy makers and academic researchers.

A report is being submitted to the funders (NIHR) which provides a narrative on the methodology, the results, the conclusions and recommendations. The project has developed a new prognostic model, including 9 variables, which performs well in predicting hospital admissions among people with COPD. This model can be used to guide and to prioritise patient management.

The findings of the overall study and the results of interim analyses during the study period will also be and, in the case of some interim findings, have been be disseminated via academic peer-reviewed papers and conference presentations. Publications and presentations will continue beyond the current study period.

Outputs present group-level data only (e.g. proportion of patients with specified characteristics/outcomes). All data included in outputs are aggregated with small numbers suppressed in line with the HES Analysis Guide. The funder’s report is solely for the purposes of the funding body. All academic publications will be ‘open-access’ (available to members of the public without cost) and will be available on the websites of the publishing journal as well as through the study website (www.birmingham.ac.uk/bliss).

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

In line with the above statement, the analyses and measurable benefits for this study are planned for 2019 and beyond. Although the main analyses are completed for the report to the NIHR (the funder), further analyses are ongoing for publication of academic papers and conference presentations at a later date