NHS Digital Data Release Register - reformatted

Health And Safety Executive projects

415 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).

🚩 Health And Safety Executive was sent multiple files from the same dataset, in the same month, both with optouts respected and with optouts ignored. Health And Safety Executive may not have compared the two files, but the identifiers are consistent between datasets, and outside of a good TRE NHS Digital can not know what recipients actually do.

MR468 - Mesothelioma Register — DARS-NIC-147839-Y4RRC

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable

Legal basis: , Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007

Purposes: No (Agency/Public Body)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2012-07-17 — 2027-07-17

Access method: Ongoing

Data-controller type: HEALTH AND SAFETY EXECUTIVE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Flagging Current Status Report
  4. MRIS - Members and Postings Report
  5. MRIS - Personal Demographics Service
  6. MRIS - Scottish NHS / Registration

Objectives:

The aims of this study are: -

To maintain Health and Safety Executive's Mesothelioma and Asbestosis Registers so as to provide accurate statistics on trends of the incidence of mesothelioma and asbestosis, important and potentially preventable causes of work-related disability and death.

To provide information on incidence of these diseases, an important long-term measure of the justification for and continuing effectiveness of stringent work-place measures for the control of asbestos exposure.

To inform policy developments to provide a better focus of these control measures and the regulations to enforce them.

To allow statistical modelling of the future burden of mesothelioma deaths in Great Britain. Information on rising incidence of mesothelioma, projected to continue for some years yet has implications for those providing care, for the UK's no fault compensation system for work-related disease and injury, and for the UK insurance industry.

MR5 (a) : Patient flagging for Asbestos Workers — DARS-NIC-337801-K2N5Y

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes (Consent (Reasonable Expectation), Section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(7), Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'.

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2019-09-15 — 2022-09-14 2019.03 — 2024.03.

Access method: One-Off, Ongoing

Data-controller type: HEALTH AND SAFETY EXECUTIVE

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. MRIS - Members and Postings Report
  5. Civil Registration - Deaths
  6. Demographics
  7. Cancer Registration Data
  8. Civil Registrations of Death

Objectives:

The Health and Safety Executive's aim of the Asbestos Workers Survey is to monitor the long-term mortality and cancer incidence among asbestos removal workers who are now the main worker group with the highest potential for exposure to asbestos in the UK. This will enable the Health and Safety Executive to continue to evaluate its policy of progressively tightening the regulatory framework with regard to working with asbestos, and to inform future policy decisions. The study will also provide valuable information about the long-term health risks of workers in the British asbestos product manufacturing industry before the mid-1980s which will contribute to improving the evidence base about the general relationship between asbestos exposure and disease which is needed for risk assessment purposes both in the UK and internationally.

The objectives of the processing will be to analyse the data in order to:

• Compare cancer incidence and mortality among the asbestos workers with the general population, and between different groups of asbestos workers who have worked with asbestos in different ways and had different amounts of exposure, for example insulation workers compared to manufacturing workers.

• Provide relevant data about the situations associated with increased risk of asbestos-related disease in this population in order to inform policy with respect to regulating the health risks associated with exposure to asbestos in the workplace.

Yielded Benefits:

The Asbestos Workers Survey is of international importance because of its large size and length of follow-up. and its findings have made significant contributions to the knowledge base. Survey findings have been published in HSE Research Reports and in peer reviewed journals. Peer reviewed articles have covered mortality among all asbestos workers; mortality among asbestos removal workers; asbestosis and mesothelioma mortality among all asbestos workers; the joint effect of smoking and asbestos exposure on lung cancer mortality; and the latency period of mesothelioma. Together these articles have been cited over 160 times. In addition, McCormack et al used published data from the study to estimate the asbestos-related lung cancer burden from mesothelioma mortality (Br J Cancer, 2012). Information received from NHS Digital and its predecessors were critical in all these publications.

Expected Benefits:

The work of the regulatory body for asbestos, the Health and Safety Executive (HSE), is very important from a public health perspective and from the perspective of individual asbestos workers. The regulatory framework has been devised in such a way as to minimize the health risks associated with working with asbestos.

The benefit from the progressively tighter regulation of asbestos exposure at work is expected to be a reduction in the number asbestos related deaths among men and women occupationally exposed to asbestos. The findings from the Asbestos Workers Survey will help to demonstrate whether there is evidence that the regulations are effective in controlling these health risks. Previous analysis of the survey data suggested that men and women who are first occupationally exposed to asbestos in more recent times are at lower risk of these diseases. However, the nature of the diseases associated with asbestos means that longer follow-up is required to provide more conclusive evidence.

Without longer follow-up, HSE would no longer be in a position to track the trend in asbestos related disease in these workers. This would have a major impact on this survey which has been running for more than 40 years, and would negatively affect HSE’s ability to monitor the long-term health of asbestos workers.

The findings from this survey will be used by HSE to inform its policy with respect to regulating exposure to asbestos at work.

Outputs:

The Asbestos Workers Survey produces regular updates on mortality in the cohort which indicate the trends in mortality over time. It is expected that in the next update, mortality to the end of 2015 will be analysed, but the timing of this will depend on the Data Sharing Agreement being in place.

In addition to these analyses, the Health and Safety Executive (HSE) determines the need for additional analyses of the data to address specific questions. Currently, whether the risks of lung cancer and mesothelioma differ between the various types of asbestos is being investigated. The first output from this investigation, a peer reviewed journal manuscript, is expected approximately three months after the Data Sharing Agreement for the study is in place.

Identifiable data will not be shared with third parties; only the results from statistical analysis will be shared. The results will take the form of aggregated data, and will typically include summary statistics, and standardized mortality/incidence ratios or relative risks. Individuals will not be identifiable in these results and if there are small numbers involved in any aggregated data, these will be suppressed in accordance with current guidelines.

The survey findings will be freely available in research reports on HSE’s website or in ‘open access’ format in peer reviewed journals. The most appropriate journals will be decided upon the time of publishing but HSE has previously published findings from this study in the British Journal of Cancer, Occupational and Environmental Medicine, Occupational Medicine Journal and the American Journal of Industrial Medicine. Findings will also be presented at relevant conferences; in the past these have included the International Epidemiology in Occupational Health (EPICOH) conference, the UK & Ireland Occupational & Environmental Epidemiology Conference, and the British Occupational Hygiene Society Annual Conference.

As a publicly funded research study, it is HSE policy to ensure that outputs are published and that the publications are open access so that they are accessible to all. However, it is not possible to determine exactly where each set of findings will be published. At this point HSE are providing a list of possibilities based on HSE's experience with similar studies. Outputs may be published in more than one format for example as a research report and as a conference presentation.

The data will not be used for commercial purposes.

Processing:

The electronic data are stored on servers at the HSE's Bootle location with servers in its Basingstoke location used as contingency if and when, for whatever reason, the Bootle servers are unavailable. The data will be accessed via hardware in the Health and Safety Executive’s (HSE’s) laboratory in Buxton, Derbyshire connecting to the HSE network. Archived paper records are stored at the Buxton location. Other than for storage, no data is processed outside of the Buxton location.

All data transfers between NHS Digital and HSE will be undertaken using NHS Digital’s secure file transfer system. Any information received from NHS Digital will be downloaded onto a restricted access encrypted network drive, dedicated to the study.

The majority of study members recruited prior 2006 had already been flagged with NHS Digital but these were flagged in the same cohort as members recruited from 2006 onwards whom had given sufficiently informed consent to the processing of their data. To enable national patient opt-outs to be appropriately applied to the data of study members who have not given sufficient informed consent, the cohort flagged on the MRIS system will be deleted and the cohort will be re-flagged in separate subsets.

The HSE will provide a list of identifying details of study members recruited prior to 2006. NHS Digital will flag these in a new cohort which will be kept separate from study members recruited from 2006 onwards. No new cohort members will be added to this subset of the cohort for which section 251 support provides the basis to process their data without consent. New members may only be added to the subset of members recruited from 2006 onwards if those members have given valid consent.

NHS Digital will provide to HSE notifications of participants' deaths (including date and cause), cancer registrations and exits from or re-entries to NHS registration.

Access to the data is limited to authorised substantive employees of HSE exclusively at the Buxton site. No other HSE employees will access the data. No data will be accessible to third parties outside of HSE.

For clarification, for the purpose of comparing cancer incidence and mortality amount the asbestos workers and subcategories thereof with the general population, the HSE will compare aggregated statistics with publicly available national statistics.

ONS terms and conditions relating to the data being shared under this agreement will be adhered to.

MR5(b) : Patient flagging for Asbestos Workers — DARS-NIC-183842-H8L1J

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2019-03-31 — 2022-03-31 2019.03 — 2024.03.

Access method: One-Off, Ongoing

Data-controller type: HEALTH AND SAFETY EXECUTIVE

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. MRIS - Members and Postings Report
  5. Demographics
  6. Civil Registration - Deaths
  7. Cancer Registration Data
  8. Civil Registrations of Death

Objectives:

The Health and Safety Executive's aim of the Asbestos Workers Survey is to monitor the long-term mortality and cancer incidence among asbestos removal workers who are now the main worker group with the highest potential for exposure to asbestos in the UK. This will enable the Health and Safety Executive to continue to evaluate its policy of progressively tightening the regulatory framework with regard to working with asbestos, and to inform future policy decisions. The study will also provide valuable information about the long-term health risks of workers in the British asbestos product manufacturing industry before the mid-1980s which will contribute to improving the evidence base about the general relationship between asbestos exposure and disease which is needed for risk assessment purposes both in the UK and internationally.

The objectives of the processing will be to analyse the data in order to:

• Compare cancer incidence and mortality among the asbestos workers with the general population, and between different groups of asbestos workers who have worked with asbestos in different ways and had different amounts of exposure, for example insulation workers compared to manufacturing workers.

• Provide relevant data about the situations associated with increased risk of asbestos-related disease in this population in order to inform policy with respect to regulating the health risks associated with exposure to asbestos in the workplace.

Yielded Benefits:

The Asbestos Workers Survey is of international importance because of its large size and length of follow-up. and its findings have made significant contributions to the knowledge base. Survey findings have been published in HSE Research Reports and in peer reviewed journals. Peer reviewed articles have covered mortality among all asbestos workers; mortality among asbestos removal workers; asbestosis and mesothelioma mortality among all asbestos workers; the joint effect of smoking and asbestos exposure on lung cancer mortality; and the latency period of mesothelioma. Together these articles have been cited over 160 times. In addition, McCormack et al used published data from the study to estimate the asbestos-related lung cancer burden from mesothelioma mortality (Br J Cancer, 2012). Information received from NHS Digital and its predecessors were critical in all these publications.

Expected Benefits:

The work of the regulatory body for asbestos, the Health and Safety Executive (HSE), is very important from a public health perspective and from the perspective of individual asbestos workers. The regulatory framework has been devised in such a way as to minimize the health risks associated with working with asbestos.

The benefit from the progressively tighter regulation of asbestos exposure at work is expected to be a reduction in the number asbestos related deaths among men and women occupationally exposed to asbestos. The findings from the Asbestos Workers Survey will help to demonstrate whether there is evidence that the regulations are effective in controlling these health risks. Previous analysis of the survey data suggested that men and women who are first occupationally exposed to asbestos in more recent times are at lower risk of these diseases. However, the nature of the diseases associated with asbestos means that longer follow-up is required to provide more conclusive evidence.

Without longer follow-up, HSE would no longer be in a position to track the trend in asbestos related disease in these workers. This would have a major impact on this survey which has been running for more than 40 years, and would negatively affect HSE’s ability to monitor the long-term health of asbestos workers.

The findings from this survey will be used by HSE to inform its policy with respect to regulating exposure to asbestos at work.

Outputs:

The Asbestos Workers Survey produces regular updates on mortality in the cohort which indicate the trends in mortality over time. It is expected that in the next update, mortality to the end of 2015 will be analysed, but the timing of this will depend on the Data Sharing Agreement being in place.

In addition to these analyses, the Health and Safety Executive (HSE) determines the need for additional analyses of the data to address specific questions. Currently, whether the risks of lung cancer and mesothelioma differ between the various types of asbestos is being investigated. The first output from this investigation, a peer-reviewed journal manuscript, is expected approximately three months after the Data Sharing Agreement for the study is in place.

Identifiable data will not be shared with third parties; only the results from statistical analysis will be shared. The results will take the form of aggregated data, and will typically include summary statistics, and standardized mortality/incidence ratios or relative risks. Individuals will not be identifiable in these results and if there are small numbers involved in any aggregated data, these will be suppressed in accordance with current guidelines.

The survey findings will be freely available in research reports on HSE’s website or in ‘open access’ format in peer reviewed journals. The most appropriate journals will be decided upon the time of publishing but HSE has previously published findings from this study in the British Journal of Cancer, Occupational and Environmental Medicine, Occupational Medicine Journal and the American Journal of Industrial Medicine. Findings will also be presented at relevant conferences; in the past these have included the International Epidemiology in Occupational Health (EPICOH) conference, the UK & Ireland Occupational & Environmental Epidemiology Conference, and the British Occupational Hygiene Society Annual Conference.

As a publicly funded research study, it is HSE policy to ensure that outputs are published and that the publications are open access so that they are accessible to all. However, it is not possible to determine exactly where each set of findings will be published. At this point HSE are providing a list of possibilities based on HSE's experience with similar studies. Outputs may be published in more than one format for example as a research report and as a conference presentation.

The data will not be used for commercial purposes.

Processing:

The electronic data are stored on servers at the HSE's Bootle location with servers in its Basingstoke location used as contingency if and when, for whatever reason, the Bootle servers are unavailable. The data will be accessed via hardware in the Health and Safety Executive’s (HSE’s) laboratory in Buxton, Derbyshire connecting to the HSE network. Archived paper records are stored at the Buxton location. Other than for storage, no data is processed outside of the Buxton location.

All data transfers between NHS Digital and HSE will be undertaken using NHS Digital’s secure file transfer system. Any information received from NHS Digital will be downloaded onto a restricted access encrypted network drive, dedicated to the study.

The majority of study members who consented to participate from 2006 onwards had already been flagged with NHS Digital but these were flagged in the same cohort as members recruited prior to 2006 for whom section 251 support had been granted. To enable Type 2 Patient Objections to be appropriately applied to the data of study members who have not given sufficient informed consent, the cohort flagged on the MRIS system will be deleted and the cohort will be re-flagged in separate subsets.

The HSE will provide a list of identifying details of study members who gave consent from 2006 onwards. NHS Digital will flag these in a new cohort which will be kept separate from study members recruited prior to 2006 who have not since given updated consent. No new cohort members will be added to this subset of the cohort under this Data Sharing Agreement. It is possible that new members may be added to this subset under a future Agreement if members have given valid informed consent to the processing of their data for the purposes described.

NHS Digital will provide to HSE notifications of participants' deaths (including date and cause), cancer registrations and exits from or re-entries to NHS registration.

Access to the data is limited to authorised substantive employees of HSE exclusively at the Buxton site. No other HSE employees will access the data. No data will be accessible to third parties outside of HSE.

For clarification, for the purpose of comparing cancer incidence and mortality amount the asbestos workers and subcategories thereof with the general population, the HSE will compare aggregated statistics with publicly available national statistics. The HSE will not link the data further and the only data linkages are those permitted under this Agreement.

All organisations party to this Agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract - i.e. employees, agents and contractors of the Data Recipient who may have access to that data).

MR534 Pesticide Users’ Health Study — DARS-NIC-351522-Y6W3L

Type of data: information not disclosed for TRE projects

Opt outs honoured: Yes - patient objections upheld, Identifiable, Yes (Section 251, Section 251 NHS Act 2006)

Legal basis: Approved researcher accreditation under section 39(4)(i) and 39(5) of the Statistical Registration Service Act 2007 , Section 251 approval is in place for the flow of identifiable data, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 - s261(5)(d); National Health Service Act 2006 - s251 - 'Control of patient information'., Health and Social Care Act 2012 - s261(5)(d)

Purposes: No (Agency/Public Body)

Sensitive: Sensitive, and Non Sensitive, and Non-Sensitive

When:DSA runs 2019-06-18 — 2022-06-17 2017.12 — 2024.03.

Access method: Ongoing, One-Off

Data-controller type: HEALTH AND SAFETY EXECUTIVE

Sublicensing allowed: No

Datasets:

  1. MRIS - Cause of Death Report
  2. MRIS - Cohort Event Notification Report
  3. MRIS - Members and Postings Report
  4. Hospital Episode Statistics Admitted Patient Care
  5. Civil Registration - Deaths
  6. Demographics
  7. Cancer Registration Data
  8. MRIS - Flagging Current Status Report
  9. Hospital Episode Statistics Admitted Patient Care (HES APC)
  10. Civil Registrations of Death

Objectives:

The Pesticide Users’ Health Study was established in the late 1990s, with the aim to monitor the long-term health of people who use pesticides as part of their work. Monitoring mortality and cancer incidence among study members is an important part of this. Mortality up until 2005 and cancer incidence up until 2004 have already been analysed and published in Health & Safety Executive Research Reports and a peer-reviewed publication (http://www.hsl.gov.uk/resources/major-projects/puhs). Additional follow-up will help to clarify some of the results observed, and will add to the literature on the potential link between pesticides and ill health.

Cancer and death registrations do not necessarily capture conditions that do not tend to lead to death. Conditions such as neurological, eye, respiratory, and skin diseases have all been linked to potential pesticide exposure, but the evidence is inconclusive. These conditions will not necessarily be captured on death certificates, but individuals with these diseases could have been admitted to hospital.

The specific objectives of the processing will be to;
1) analyse cancer incidence and mortality among members of the Pesticide Users’ Health Study, comparing these rates to the general population and investigating trends between groups where possible (for example, between regions and types of pesticide use).
2) Analyse hospital admissions due to neurological, eye, respiratory, or skin disease among members of the Pesticide Users’ Health Study, comparing these rates to the general population and investigating trends between groups where possible (for example, between regions and types of pesticide use).

HSE are therefore requesting the following to answer the two objectives above:
1) Objective 1: Individual-level data relating to cancers, deaths, and emigrations, linked to study members. In the past, this has been received from NHS Digital (and its predecessors) on a quarterly basis, and HSE wish this to continue into the foreseeable future. These data will be analysed on a regular basis.
2) Objective 2: Episode-level hospital admission data, linked to study members, was received as a one-off request under the previous DSA. HSE would like to continue processing, analysing and reporting using these data under this DSA.

Yielded Benefits:

The peer-reviewed article investigating mortality and cancer incidence, which was published in 2011, has been cited by around 30 articles looking at topics including testicular cancer, organophosphate insecticide use and lymphohematopoietic cancers. All of which are topics still debated in the literature and the results from the Pesticide Users' Health Study were able to contribute to this thanks to the information from NHS Digital and its predecessors.

Expected Benefits:

The Pesticide Users’ Health Study is a large study of individuals potentially exposed to low levels of pesticides over a long period. As such, it is a valuable resource that can make a worthwhile contribution to the wider literature on pesticides and health, and help to elucidate some of the current inconsistencies in the literature. The study and its results has already paved the way for a new separate cohort study, which will collect more detailed information but on a smaller number of pesticide users.

The Pesticide Users’ Health Study forms an integral part of the Health & Safety Executive’s commitment to protecting the health of people at work. Hence, the results of this study, and a greater understanding of the potential risks involved in pesticide use, could help to inform future policy. Policy colleagues will be able to consider the results of this study, together with the wider body of evidence about the safety of licensed pesticides, in any decision process. In addition, all of the results will be publicly available, which will raise the awareness of the potential effects of working with pesticides among the public, workers, and bystanders, and encourage care and vigilance in the way that pesticides are used. All of this will help to protect the health of users of pesticides.

Outputs:

Results of all analyses will be published in Health & Safety Executive Research Reports (http://www.hse.gov.uk/research/rrhtm/), peer-reviewed journal publications, or presented at conferences where appropriate.

The most appropriate journals will be decided upon at the time of publication. Examples of journals this study and other similar studies have published in previously include Occupational Medicine, British Journal of Cancer, and Annals of Occupational Hygiene.

As with journals, the most appropriate conference will be decided upon at the time. Examples of conferences this study and other similar studies have presented at previously include The International Epidemiology in Occupational Health (EPICOH) Conference, The UK & Ireland Occupational & Environmental Epidemiology Conference, and The British Occupational Hygiene Society Annual Conference.

The results will take the form of aggregated data, and will typically include summary statistics, and standardized mortality/incidence/admission ratios or relative risks. Individuals will not be identifiable in these results and if there are small numbers involved in any aggregated data, these will be suppressed in accordance with current guidelines.

All outputs will be aggregated with small numbers suppressed and will follow the HES analysis guide.

The data will not be used for commercial purposes.

Objective 1: Ongoing cancers, deaths, and emigrations
Previous analysis of mortality and cancer incidence included follow-up to 2005, and so it is expected that an updated analysis will be completed shortly using the additional 10 years’ follow-up data. This is an on-going study, and updated analyses will be undertaken periodically after this.

In addition to these analyses, the Health and Safety Executive may request additional analyses of the data to address specific questions.

Objective 2: One-off linkage and tabulation of hospital admissions
This analysis is expected to be completed and the results published by April 2019.

Processing:

The data will be processed at the Health & Safety Laboratory (HSL), which is part of the Health & Safety Executive (HSE).

All data transfers between NHS Digital and HSE will be undertaken using NHS Digital's secure file transfer system. Any information received from NHS Digital will be downloaded directly onto a restricted access network drive, dedicated to the study.

Access to the data is limited to authorised substantive employees of the HSE exclusively within the HSL at the Buxton address. No other HSE employees will access the data at any other location. No data will be accessible to third parties outside of HSE.

The data will only be used for the purpose as stated.

Objective 1: Ongoing cancers, deaths, and emigrations

Linkage has already been undertaken by NHS Digital, with updates on cancer and death registrations, and embarkations and returns previously received on a quarterly basis. Hence, there will be no information transferred from HSE to NHS Digital.

It is hoped that NHS Digital will continue to send the event notification file and the death notification file on a quarterly basis using their secure file transfer system. This will be downloaded directly onto a restricted access network drive, dedicated to this study. Identifiable data is requested for data quality purposes, but analysis is conducted on data with identifiers removed.

Historical data from NHS Digital (and its predecessors) are on the study database. However, due to changing IT, the database no longer supports upload of new data from NHS Digital. Until a solution is in place, the information provided by NHS Digital will be stored electronically on the restricted access network drive.

To process the data ready for analysis and reporting in the specified outputs, the data are extracted from the database in three csv files: one file contains details on the participants and includes NHS numbers and dates/causes of death (if relevant); one contains details on the certifications the individuals have undertaken; and one on cancer registrations that have been entered onto the database. These files are saved on the restricted access network drive, which is dedicated to this study. Linkage of the different files is through the unique study ID number.

Stata statistical software is then used to link the files and de-identify the data as much as possible before analysis. Information such as name, address and NHS number is removed. Information such as date of death, cause of death, date of cancer registration, sex, postcode and study ID number remain for the analysis. Only the de-identified dataset is used during analysis. Analysis is conducted using Stata statistical software, and all files relating to the analysis are saved on the restricted access network drive for the study.

Objective 2: One-off linkage to hospital admission data

This linkage has already been undertaken by NHS Digital and the extract has been received by HSE. Preliminary data cleaning/checking has been undertaken.

As this is a one-off analysis, this data will not be stored on the study database but willl be stored electronically on the restricted access network drive.

The analysis that HSE plans to undertake will require linking the episode level data to the following information on study participants (held by HSE and linked, by HSE, through the study ID):

1) Baseline information: date of birth, sex, address, pesticide certificates held. Collected at the time of recruitment.
2) Date of death or emigration (if applicable).
3) Information on pesticide use, collected from a subset of participants.

Stata statistical software will be used to link the files and pseudonymise the data as much as possible before analysis. Information such as name, address and NHS number will be removed. Information such as date of death, date of emigration, sex, postcode and study ID number will remain for the analysis. All information requested on hospital admissions will be retained for the anlaysis. Only the pseudonymised dataset will be used during the analysis.

The analysis will be conducted using Stata statistical software, and all files relating to the analysis will be saved in the restricted access network drive for the study.,

MR1392 - The Prospective Investigation of Pesticide Applicators’ Health Study (PIPAH) — DARS-NIC-385032-K3N9S

Type of data: information not disclosed for TRE projects

Opt outs honoured: No - consent provided by participants of research study, Identifiable, No (Reasonable Expectation, Consent (Reasonable Expectation))

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC, Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(2)(c), Health and Social Care Act 2012 – s261(7), Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (Agency/Public Body)

Sensitive: Sensitive

When:DSA runs 2019-03-01 — 2022-02-28 2017.09 — 2024.03.

Access method: Ongoing, One-Off

Data-controller type: HEALTH AND SAFETY EXECUTIVE

Sublicensing allowed: No

Datasets:

  1. MRIS - Flagging Current Status Report
  2. MRIS - Cause of Death Report
  3. MRIS - Cohort Event Notification Report
  4. Demographics
  5. Civil Registration - Deaths
  6. Cancer Registration Data
  7. MRIS - Members and Postings Report
  8. Civil Registrations of Death

Objectives:

The overall aims of the study are to monitor the health of workers in Great Britain who use pesticides as a part of their job, and to gain a better understanding of the relationship between long-term exposure to pesticides and health. This will help the Health & Safety Laboratory (HSL), which is part of Health & Safety Executive, to make informed decisions on future policies.

Monitoring mortality and cancer incidence is an important part of this, and will provide information on the health risk of individuals working with pesticides.

In addition, the availability of routinely collected data for research purposes is increasing, and the study would like to ensure that it can make full use of these if required in the future. Some datasets may be region specific, and so it is important that HSL can track study participants even after HSL have lost contact with them. Therefore HSL are also requesting information on emigrations and the health authority cipher.


The specific objectives of the processing will be to:

1) ensure that HSL do not attempt to contact study members who have died or have emigrated outside of Great Britain;

2) compare cancer incidence and mortality among study members with the general population, and between different groups of study members who have worked with pesticides in different ways, for example comparing people who have used different pesticides; and

3) keep track of study members' area of residence / registration to aid future potential data linkages.


For information only, a long-term goal is to enable other researchers to use the data generated by this study. Specific consent has been sought from study members to do this. Any additional uses of the data would be subject to the approval of future applications to NHS Digital.

The previous data request for this study was for NHS Digital (formerly known as Health and Social Care Information Centre) to notify HSL of which study members had died. This prevented HSL contacting deceased individuals in the January 2016 mailing and potentially causing relatives distress. This was a one-off request, and HSL are now requesting on-going patient tracking.

HSE do not current hold any HES data for the purpose of this study

Yielded Benefits:

Study participants are contacted annually and keeping the mailing list current ensures that only contact study participants who are still alive are sent the newsletter and any follow-up questionnaire. This is important to avoid causing distress to deceased participants' families. The latest newsletter and questionnaire were sent to participants early in 2019, this one is currently providing the greatest yielded benefit. Processing the data was enabling the investigation of cancer incidence and mortality among the study members. To date one analysis has been undertaken using the mortality data. There is some evidence that populations exposed to pesticides may be at higher risk of developing neurological conditions. So the standardised mortality ratios were calculated for neurological conditions among the study population, using national mortality data as the reference population. As the study matures, the yielded benefits from this expected output will increase because the number of events will accumulate over time. Future anticipation is to keep track of study members and making data linkages, will yield benefits in the longer term. Currently there are no plans to make data linkages, and the contact details of the participants in this relatively new follow-up study are still up-to-date.

Expected Benefits:

The PIPAH study is a detailed study of individuals who use pesticides as part of their work and are potentially exposed to low levels of pesticides over a long period. It was established by the Health & Safety Executive in order to monitor the long-term health of these individuals because other systems of surveillance for pesticide exposures only cover acute health outcomes. The study helps the Health & Safety Executive to determine the long-term safety of pesticides licensed for use in GB and is an integral part of the Health & Safety Executive's commitment to protecting the health of people at work.

The study is a valuable resource that will make a worthwhile contribution to the wider literature on pesticides and health, and help to elucidate some of the current inconsistencies in the literature. The study is part of a consortium of agricultural cohort studies (AGRICOH) and in future will partake in pooling studies to investigate specific health outcomes, including rare health outcomes which cannot be addressed by individual studies (permission to pool data will be requested from NHS Digital before any data are shared). This will provide further benefits to the knowledge base on pesticides beyond those which any individual study can provide. Dissemination of findings by various means will help to inform pesticide users, researchers, regulatory agencies and the wider public about the safety of pesticides licensed for use in GB.

As a long-term study, the value of the findings will increase as the length of follow-up increases. Currently there are no set target dates for any outputs beyond periodic analysis of health outcomes to monitor the health of the participants. Further analyses to address specific knowledge gaps will be determined by the Health & Safety Executive. The results of this study, and the greater understanding of any potential risks involved in pesticide use which the study will provide, will help to inform the Health & Safety Executive’s future policy with respect to licensing particular pesticides.

This Health & Safety Executive funded study is operationally carried by out at HSE Buxton. The outputs from this study will contribute to the body of evidence about the safety of licensed pesticides which the Health & Safety Executive will take into account in any decision process.

Outputs:

The expected outputs from processing are threefold:

1) The study participants are contacted annually in order to send them the study Newsletter and follow-up questionnaires. It is therefore important to maintain an up-to-date mailing list to ensure that the study team does not attempt to contact any deceased participants. Receiving information on death registrations and the Members and Postings lists will enable the study team to keep the mailing list up-to-date into the future.

2) The main outcomes of interest to the study are cancer incidence and mortality. The statistical analyses will use these outcomes to compare the health of the study members with the general population, and compare groups of study members with different exposures. It is critical for analytical purposes to know which participants have died or emigrated so that their end of follow-up dates can be incorporated in any prospective data analysis.

The resulting outputs from this research study will be published. How the outputs will be published will be determined by the study team to ensure that the findings reach the most appropriate audience. The resulting outputs from the analysis of the study data may be published in Health & Safety Executive Research Reports (http://www.hse.gov.uk/research/rrhtm/), which will be made freely available to researchers and the public on the Health & Safety Executive website. Peer-reviewed journal publications will be prepared where appropriate, and these will be 'open access' so that both researchers and the public can view papers. The most appropriate journals will be decided upon at the time of publication. Examples of journals other similar studies have published in previously include 'Occupational Medicine', 'British Journal of Cancer', and 'Annals of Occupational Hygiene'.

Results may also be presented at conferences to researchers where appropriate. As with journals, the most appropriate conference will be decided upon at the time. Examples of conferences this study and other similar studies have presented at previously include The International Epidemiology in Occupational Health (EPICOH) Conference, The UK & Ireland Occupational & Environmental Epidemiology Conference, and The British Occupational Hygiene Society Annual Conference.

As a publicly funded research study, it is HSE policy to ensure that outputs are published and that the publications are ‘open access’ so that they are accessible to all. However it is not possible to determine exactly where each set of findings will be published. At this point HSE are providing a list of possibilities based on HSE's experience with similar studies. Outputs may be published in more than one format – for example as a research report and as a conference presentation.

A newsletter is produced annually to keep study members up-to-date with progress on the study. This will also include study results and details of where to find more information.

The results will take the form of aggregated data, and will typically include summary statistics, and standardised mortality/incidence/admission ratios or relative risks. Individuals will not be identifiable in these results and if there are small numbers involved in any aggregated data, then these will be suppressed in accordance with the HES Analysis Guide.

This is a long-term cohort study which will entail the initial analysis of the baseline data, followed by periodic analysis of the health outcome data (self-reported ill-health, cancers, deaths and HES data) collected during follow-up. The baseline data analysis is on-going; the first publications (two Health & Safety Executive Research Reports and one journal publication) were published during 2016. The first peer reviewed paper describing the establishment of the cohort is expected to be published in 2017. Further baseline data analyses (for example of specific groups of self-reported ill health, such as respiratory health) will be undertaken until sufficient follow-up data is available for prospective analysis. The timetable for the periodic analyses will be determined by the Health & Safety Executive to meet its requirements.

The data will not be used for commercial purposes.

Under the previous data request to NHS Digital in 2015, participants who had consented and were found to be alive (as identified by NHS Digital) were sent a newsletter and questionnaire to complete. These questionnaires will feed in to the study outputs described above.

3) Maintaining an up-to-date list of study participants will help the study team keep track of study members and will aid future potential data linkages. This will help to reduce losses-to-follow up and attrition in participant numbers as the study matures.

Processing:

The data will be processed at the Health & Safety Laboratory (HSL), which is part of the Health & Safety Executive (HSE).

All data transfers between NHS Digital and HSL will be undertaken using the NHS Digital's secure file transfer system. Any information received from NHS Digital will be downloaded directly onto a restricted access network drive, dedicated to the study.

Access to the data is limited to authorised substantive employees of the HSE exclusively within the HSL at the Buxton address. No other HSE employees will access the data at any other location. No data will be accessible to third parties outside of HSE.

The data will only be used for the purpose as stated.

The flow of data will be as follows:

1) The HSL study team will send NHS Digital the following information on study members where available: study ID; NHS number; Forename; Middle name; Surname; Date of birth; Sex and Address (including postcode. This will enable linkage to be undertaken by NHS Digital.

2) NHS Digital will provide the HSL study team the requested records.

3a) The study database is currently under development. Until this is finished, the information provided by NHS Digital will be stored electronically on the restricted access network drive.

HSL expect that the study database will be ready for data entry by April 2017 at the earliest. When finished, the database will reside in HSL on an SQL server at Buxton, which HSL control. The restricted access network drive is on an HSL server at Harpur Hill, Buxton, with access only granted to authorised members of staff.

The requested data are needed before the study database is complete for two reasons. First, the data required for objective 1 (alive/dead status) is needed for any mail outs before the database will be complete. Second, it will greatly help with database development to have access to the raw data from NHS Digital.

3b) Once complete, all information received from NHS Digital will be uploaded onto the study database. Identifiable information that HSL holds will either be stored on the same database as the research data but partitioned/secured using SQL schema or a bespoke service API, or will be held on a separate database. Restrictions will be in place so that only study team members with the correct permissions will be able to access data received from the NHS Digital. In addition, the database will be encrypted.

4) Data required for the different objectives will be extracted from the database by study team members with the correct permissions. All study team members are substantive employees of the data controller. Only the information required will be extracted. Extracted datasets will contain the minimum identifiable fields required, and will be saved on the restricted access network drive for the study. All data processing will be conducted on the restricted access network drive.

The information from NHS Digital will be linked to research data collected from the participants throughout the duration of the study to enable analysis. This includes the following information:

- responses to a baseline questionnaire collecting information on work history, previous work with pesticides, general health, family medical history, lifestyle, diet, tobacco and alcohol use, and socio-economic circumstances;

- responses to a questionnaire on current pesticide use;

- future updates to this information.