NHS Digital Data Release Register - reformatted
Health and Safety Executive
Project 1 — DARS-NIC-351522-Y6W3L
Opt outs honoured: Yes - patient objections upheld (Section 251)
Sensitive: Non Sensitive, and Sensitive
When: 2016/12 — 2018/12.
Repeats: One-Off, Ongoing
Legal basis: Section 251 approval is in place for the flow of identifiable data, 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)
Categories: Anonymised - ICO code compliant, Identifiable
- Hospital Episode Statistics Admitted Patient Care
- MRIS - Cause of Death Report
- MRIS - Cohort Event Notification Report
- MRIS - Members and Postings Report
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.
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). HSL are therefore requesting the following data 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 HSL 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. This is a one-off request.
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. In addition, all of the results will be publically 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.
Results of all analyses will be published in Health & Safety Executive Research Reports (http://www.hse.gov.uk/research/rrhtm/), peer-reviewed journal publications, and 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 2018.
The data will be processed, only by substantive employees, at the Health & Safety Laboratory. All data transfers between NHS Digital and HSL will be undertaken using NHS Digitals secure file transfer system. Any information received from NHS Digital will be downloaded directly onto a restricted access network drive, dedicated to the study. The data will not be accessible by a third party organization. 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 the Health & Safety Laboratory to NHS Digital. It is hoped that NHS Digital will continue to send the event notification file, 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, analysis however, is conducted on data with identifiers removed. 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 and tabulation of hospital admissions For the linked episode-level information: Linkage will be undertaken by NHS Digital. They will then provide the HSL study team with the linked hospital episode data requested, but pseudonymised with the study ID. The analysis that HSL plans to undertake will require linking the episode level data to the following information on study participants (held by HSL and linked, by HSL, 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.,
Project 2 — DARS-NIC-385032-K3N9S
Opt outs honoured: No - consent provided by participants of research study (Reasonable Expectation, Consent (Reasonable Expectation))
When: 2017/09 — 2019/01.
Repeats: Ongoing, One-Off
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)
- MRIS - Flagging Current Status Report
- MRIS - Cause of Death Report
- MRIS - Cohort Event Notification Report
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
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.
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.
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.