NHS Digital Data Release Register - reformatted

University Of Aberdeen

Project 1 — DARS-NIC-147762-6F2WZ

Opt outs honoured: Y

Sensitive: Sensitive, and Non Sensitive

When: 2016/09 — 2017/02.

Repeats: Ongoing

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

Categories: Identifiable, Anonymised - ICO code compliant

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Scottish NHS / Registration
  • MRIS - Cohort Event Notification Report

Objectives:

The data supplied will be used only for the approved medical research project MR377 - RCGP MYOCARDIAL INFARCTION STUDY


Project 2 — DARS-NIC-147835-GSMX5

Opt outs honoured: Y, N

Sensitive: Sensitive

When: 2016/04 (or before) — 2017/02.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report

Objectives:

Data supplied will be used only for the approved medical research project - MR536: Oestrogen in the Prevention of the Re-Infarction Trial (ESPIRIT)


Project 3 — DARS-NIC-147867-D8128

Opt outs honoured: Y

Sensitive: Sensitive

When: 2016/04 (or before) — 2018/05.

Repeats: Ongoing

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

Categories: Identifiable

Datasets:

  • MRIS - Cause of Death Report
  • MRIS - Cohort Event Notification Report
  • MRIS - Scottish NHS / Registration

Outputs:

Academic papers and postgraduate theses. There have been more than 120 papers so far and at least 6 MSc/MD/PhDs that have used the data so far.

Processing:

The GP's subsequently supply, at 6 monthly intervals, information about any hormonal preparations prescribed, any pregnancies and their outcome, all new episodes of illness, any surgery and any deaths occurring in women still under their observation.

Objectives:

The RCGP Oral contraception Study started in May 1968 when 1400 general practitioners (GPs) throughout the UK recruited approximately 23000 women who were using oral contraceptives and a similar number of women who had never used this method of birth control. All women were married or living as married, most were Caucasian and their mean age of recruitment was 29 years.


Project 4 — DARS-NIC-322051-S8N9N

Opt outs honoured: N

Sensitive: Sensitive

When: 2017/09 — 2017/11.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - Cohort Event Notification Report

Benefits:

KAT is the largest RCT of knee replacement ever conducted and provides a wealth of data on the management and outcomes following knee surgery. Current evidence from KAT is supportive of routine resurfacing of the patella, whatever the design of the trochlear. If a patient has not undergone primary patella resurfacing, the findings do not support late resurfacing, as this is of little, if any, benefit. The researchers found no evidence of a difference between mobile and fixed bearings in function and quality of life. Moreover, there was no significant difference in complication, re-operation or revision rates, and there was substantial uncertainty around estimated cost-effectiveness. The researchers did, however, identify two disadvantages of mobile bearings that could encourage surgeons to use fixed-bearing devices. First, there was a 2% incidence of instability or bearing dislocation in the mobile bearing group. Second, although there was no significant difference in overall costs in the long term, there was short-term saving for the hospital for fixed bearings, as they are appreciably cheaper. The findings from KAT strongly suggest that the metal-backed tibias are beneficial and cost-effective. The researchers believe that the previous recommendation that all-polyethylene tibias should be used to save money in the elderly is a false economy, as they are not only more costly in the elderly but also less effective. These findings have been published in the internationally read journal series of the HTA programme (Health Technology Assessment) which is part of the NIHR Journals Library. The journal’s impact factor of 5.116 ranks it second in the Health Care Sciences and Services category. Research conducted by the HTA programme therefore serves a variety of stakeholders including: decision-makers in local government, policy makers (including NICE), researchers, NHS health professionals, other NIHR stakeholders and the general public. The original grant from the NIHR HTA programme was to follow-up participants to a medium of 10 years. However, further funding was secured from the NIHR HTA programme to continue follow-up to 20 completed years because they were ‘convinced of the importance of the study and the need for follow up to a minimum of 20 years after TKR’. With increasing longevity of knee replacement patients, longer follow-up is however required to assess the long-term sustainability of these findings. Longer follow-up will also help to answer some important outstanding questions. In the patella resurfacing trial there was, with increasing follow-up, an increasing number of reoperations for complications of resurfacing and a decreasing number of late resurfacings. If this trend continues, the data may no longer support routinely resurfacing the patella. In the mobile bearing trial, there was a trend towards increased cost-effectiveness of mobile bearings in patients aged <70 years and fixed bearings in patients >70 years. Further follow-up is required to obtain clearer evidence to inform the use of mobile or fixed bearings. In the metal-backing trial, the KAT researchers found a trend towards an increased revision rate with all-polyethylene tibias. If this continues, the evidence will provide a strong clinical reason to avoid all-polyethylene tibias. The researchers found some evidence of potential interactions between the various different randomisations. Further follow-up is required to determine if these are important. Continuing follow-up to 20 completed years (which includes the collection of hospital readmission data) will provide long term data on the clinical and cost effectiveness of the various design options on which strong recommendations for knee replacement practice will be based. If such data is not available then the opportunity to assess the long term stability of the 10 year KAT findings will be lost. The primary benefit of receiving quarterly cohort event notifications is that it will reduce the risk of attempting to contact deceased study members thereby causing distress to living relatives.

Outputs:

The following manuscripts, all of which contained hospital readmission data obtained from participants and/or HES and ISD data have now been published: Breeman S, Campbell M, Dakin H, Fiddian N, Fitzpatrick R, Grant A, Gray A, Johnston L, MacLennan GS, Morris R, Murray D for the KAT Trial Group. Five-year results of a randomised controlled trial comparing mobile and fixed bearings in total knee replacement. Bone Joint J 2013; 95-B(4):486-92 Breeman S, Campbell M, Dakin H, Fiddian N, Fitzpatrick R, Grant A, Gray A, Johnston L, MacLennan GS, Morris R, Murray D, KAT Trial Group. Patellar resurfacing in total knee replacement: five year clinical and economic results of a large randomised controlled trial. Journal of Bone and Joint Surgery 2011;93:1473-1481 Murray DW, MacLennan GS, Breeman S, Dakin HA, Johnston L, Campbell MK, et al. A randomised controlled trial of the clinical effectiveness and cost-effectiveness of different knee prostheses: the Knee Arthroplasty Trial (KAT). Health Technol Assess 2014;18(19). Data was fully anonymised in all publications which contained only aggregate level data with small numbers suppressed in line with the HES Analysis Guide. The ten year results will also be published in peer-review journals in 2016. In addition, as it is anticipated that further HES and ISD data will be requested in the future and further publications are expected to coincide with these requests in 2018 and 2023. The quarterly cohort event notifications will be used to mitigate the risk of attempting to contact participants who have died or are lost to follow up. The remaining participants can then receive questionnaires and future information about the study via newsletters.

Processing:

The University of Aberdeen supplied the identifiers of the participants to the HSCIC including Name, NHS Number, Date of Birth, Sex, Postcode and a Unique Participant ID. The HSCIC ‘flagged’ the cohort on its computer system and supplies quarterly notifications of deaths within the study population. The data is primarily used to manage the process of mailing out participant questionnaires which are distributed by the study team to participants at 3 months post-randomisation then annually thereafter. As part of the original analyses, the cause of death data were analysed to identify possible complications from the surgeries that may have led to deaths. The patient reported outcomes collected via questionnaires are electronically captured, pseudonymised and stored in the trial database. On two previous occasions (in 2008 and 2012), the HSCIC has linked the cohort to HES data and supplied details of further knee replacements or episodes relating to further complications to the knee. The linked HES data was supplied to the KAT researchers at the University of Aberdeen. The KAT researchers then produced a file containing the details of any potentially relevant readmissions including the participant identifiers, date of admission and treatment site. The file was shared with clinical coordinators based at Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (University of Oxford) and the Department of Orthopaedic and Trauma Surgery (University of Dundee) via remote access to the University of Aberdeen’s server. The clinical coordinators then requested the details of the hospital episodes (e.g. hospital based records and hardcopy CRF forms at the time of the readmission) from the relevant treatment centre and supplied the data back to the KAT team at Aberdeen. The KAT team removed all identifiers other than the Unique Participant ID and the pseudonymised clinical data was added to the KAT database and linked to the patient reported outcomes. No data was transferred from the University of Aberdeen’s servers during this process. The remote access arrangements remain in place to enable the clinical coordinators to obtain and supply the medical records for patient reported outcomes (provided in annual questionnaire responses). The clinical coordinators at the University of Oxford could still technically access data supplied by HSCIC (i.e. the fields detailed in this paragraph only) via the remote access but access to data supplied by HSCIC is not permitted to University of Dundee. A copy of the KAT database was subsequently supplied to the KAT Health Economists at the Department of Population Health, Oxford University for health economics analysis while the KAT statisticians based at University of Aberdeen undertook the statistical analyses. This contained data that had been processed and verified by the hospital sites where the respective treatments occurred and contained no data from the HSCIC other than fact and date of death (if applicable). The data has been archived and will be retained at Oxford University for the duration of the study and for 5 years after. The processes outlined above involving use of clinical coordinators at Oxford and Dundee and involving supplying a copy of the KAT database to the Health Economist at Oxford University are expected to be repeated in the future following a planned application for further HES data. However, at the current time, there are no requirements for any additional data to be shared with these data processors and additional approvals will be sought before any additional sharing of data supplied by the HSCIC. The additional relevant clinical data collected from routine data sources (HES & ISD) provided re-admission information related to knee replacement surgery to evaluate long-term safety and need for further treatment to fulfil secondary clinical and economic outcomes and complete the overall objective of the trial. This resulted in three publications (see Outputs section). The data was fully anonymised in all publications. The ten year results are currently being written for publication and will be published in peer-review journals in late 2016. The additional data requested (notifications of deaths of cohort members on a quarterly basis until December 2022 when the last questionnaire is issued) will be processed in the same way as outlined above.

Objectives:

The Knee Arthroplasty Trial (KAT) was funded by the NIHR HTA programme to examine the clinical effectiveness and cost-effectiveness of four aspects of knee replacement surgery. Information on knee-related hospital readmissions and further surgery was collected directly from the participants (postal questionnaires) and supplemented with routinely collected information from the Hospital Episode Statistics (HES) database in England and Information services Division (ISD) in Scotland. To manage the process of sending postal questionnaires and to mitigate the risk of causing distress by sending questionnaires to deceased participants, the trial uses the HSCIC’s patient tracking service to receive notifications on participants’ deaths. Details of the cause of death were also provided and analysed to identify possible complications from the surgeries that may have led to deaths. Due to the length of time elapsed since the surgeries, cause of death will not be analysed in the extended study and so only date of death will be provided on an ongoing basis. The KAT researchers have also recently secured funding to continue follow-up to 20 completed years (end date 30 June 2023). It is therefore anticipated that further HES and ISD data will be requested and supplied in the future (2017 and 2022).


Project 5 — DARS-NIC-384722-W7Y8W

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: Ongoing

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Identifiable

Datasets:

  • MRIS - List Cleaning Report

Benefits:

Haemorrhoids are common in all age groups from mid-teens onwards. The currently available data comparing the clinical and cost-effectiveness of stapled haemorrhoidopexy and conventional excisional haemorrhoidectomy are poor. The results of the eTHoS trial will be available in late 2016/early 2017. The expected benefits to the NHS will be that the trial will provide robust information about which of the two surgical procedures for haemorrhoids is the most clinically successful and cost effective again by comparing variables such as haemorrhoid reoccurrence and further surgeries in both surgical procedure arms. This information will enable cost savings to the NHS and will directly benefit patients. The trial will provide information about the quality of life for the patients who have had the surgical procedures, including pain, recurrence, time to recovery, faecal urgency, and adverse effects of treatment. This information can be used to select the appropriate type of procedure for optimal outcomes and patient experience. The patient experience is a core objective of the trial. The Department of Health has requested this study and will use its results to determine the optimum approach to treating patients in order to improve patient care. The HTA monograph is the report to funder (Department of Health), under the auspice of the Health Technology Assessment Programme (HTA). The HTA will disseminate the full report on their website for the information of all health care professionals for example surgeons, GPs and healthcare policy makers. Patients and the general public will also be able to have full access to the findings of the trial.

Outputs:

The full trial findings (i.e. findings from analyses or the data collected from the patient questionnaires to measure quality of life since surgery and of the data collected on haemorrhoid re-occurrence between the two surgeries and the overall analysis of the economic costs between the surgeries) will be reported in peer reviewed outputs (e.g. HTA monograph which is due to be submitted on 14th October 2016 and the main results paper which would also be submitted for publication around this time-frame depending on publisher requirements). This will be published on the HTA website and will be publically accessible. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide.

Processing:

The personal identifiers of the consented participants (cohort) will be supplied be the University of Aberdeen to the HSCIC. This will include: NHS Number, Date of Birth, Sex, Postcode and a unique participant ID. The HSCIC will supply linked HES data containing no identifiers other than the unique participant ID which will be used by the study team to re-identify the data and link it to other data collected by the study - specifically: i) Patient reported outcomes collected via questionnaires which are distributed by the study team to participants at 1, 3, 6 weeks, 12, 24 and 60 months. ii) Clinical data collected at the individual hospital centres using, where necessary, hospital based records and hardcopy CRF forms at the time of surgery and at 6-week clinical follow-up. These clinical data are then input into the eTHoS database by local researchers using an electronic web-based data capture system. Extensive range and consistency checks enhance the quality of the data. Staff in the Study Office will provide periodic data queries to local research staff to ensure that the data are as complete and accurate as possible. The additional relevant clinical data collected from routine data sources (HES & ISD) provide re-admission information related to haemorrhoids to evaluate long-term safety and the need for further haemorrhoid treatment to fulfil secondary clinical and economic outcomes and complete the overall objective of the trial. The data HSCIC provides will be used to compare effectiveness between the two surgical procedures and will not be used for any other purpose. Data will only be processed and stored at the stated location, and no record level data with be shared with any third parties.

Objectives:

Haemorrhoids are a common problem and can be painful. The symptoms can be relieved by removing the haemorrhoids in an operation. There are two ways in which surgeons can remove haemorrhoids but not enough is known about how the methods compare. Currently, surgical treatment for haemorrhoids depends on the surgeon’s preference. The eTHoS trial is a pragmatic multicentre randomized controlled trial. The objective is to compare the two kinds of operations in order to inform surgeons about which operation is best for patients (in terms of patient quality of life, health economic and clinical outcomes). In order to achieve this objective, several areas of patient care and status will need to be considered. To enable accurate and reliable analysis, patient reported health status will be collected over the trial period from patient questionnaires as well as information on symptoms related to haemorrhoids, general health and complications from either procedure collected on clinical forms. Cost between surgeries will also be evaluated and in order to fully compare the overall clinical and economic costs, readmission data from Hospital Episode Statistics (HES) and Information Services Division (ISD) Scotland is required to quantify long-term safety and haemorrhoid reoccurrence. This in turn will be used to assess the full impact of on patients’ quality of life and enable an assessment of the overall costs to the NHS if, for example, one of the surgeries resulted in higher reoccurrences and further interventions to remove haemorrhoids. The results report which will be published on the HTA (Health Technology Assessment Programme, of the National Institute for Health Research) website which will be publically accessible and will inform patients, surgeons and other health care professionals about the clinical and cost effectiveness of the two major surgical haemorrhoid interventions being investigated and provide appropriate information to help NHS Trusts to base decisions on which treatments to offer.


Project 6 — DARS-NIC-394629-C5Z4P

Opt outs honoured: N

Sensitive: Non Sensitive

When: 2016/04 (or before) — 2016/08.

Repeats: One-Off

Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC

Categories: Anonymised - ICO code compliant

Datasets:

  • Hospital Episode Statistics Outpatients
  • Hospital Episode Statistics Admitted Patient Care

Benefits:

Haemorrhoids are common in all age groups from mid-teens onwards. The currently available data comparing the clinical and cost-effectiveness of stapled haemorrhoidopexy and conventional excisional haemorrhoidectomy are poor. The results of the eTHoS trial will be available in late 2016/early 2017. The results of the study will be used to standardise surgical procedures for patients with haemorrhoids. These findings will also be published in scientific journals and presented at scientific meetings. The findings will also be made available to patients through patient organisations, health information websites that are open to the public and the media where possible and appropriate. The expected benefits to the NHS will be that the trial will provide robust information about which of the two surgical procedures for haemorrhoids is the most clinically successful and cost effective again by comparing variables such as haemorrhoid reoccurrence and further surgeries in both surgical procedure arms. This information will enable cost savings to the NHS and will directly benefit patients. The trial will provide information about the quality of life for the patients who have had the surgical procedures, including pain, recurrence, time to recovery, faecal urgency, and adverse effects of treatment. This information can be used to select the appropriate type of procedure for optimal outcomes and patient experience. The patient experience is a core objective of the trial. The Department of Health has requested this study and will use its results to determine the optimum approach to treating patients in order to improve patient care. The HTA monograph is the report to funder (Department of Health), under the auspice of the Health Technology Assessment Programme (HTA). The HTA will disseminate the full report on their website for the information of all health care professionals for example surgeons, GPs and healthcare policy makers. Patients and the general public will also be able to have full access to the findings of the trial.

Outputs:

The full trial findings (i.e. findings from analyses or the data collected from the patient questionnaires to measure quality of life since surgery and of the data collected on haemorrhoid re-occurrence between the two surgeries and the overall analysis of the economic costs between the surgeries) will be reported in peer reviewed outputs (e.g. HTA monograph which is due to be submitted on 14th October 2016 and the main results paper which would also be submitted for publication around this time-frame depending on publisher requirements). This will be published on the HTA website and will be publically accessible. Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide. If, during the course of the study, a new treatment or new information about the two surgical procedures being studied becomes available, participants will be made aware and given the option to continue or opt out of further participation in the study.

Processing:

The personal identifiers of the consented participants (cohort) will be supplied by the University of Aberdeen to the HSCIC. This will include: NHS Number, Date of Birth, Name, Address and a unique participant ID. The HSCIC will supply linked HES data containing no identifiers other than the unique participant ID which will be used by the study team to re-identify the data and link it to other data collected by the study - specifically: i) Patient reported outcomes collected via questionnaires which are distributed by the study team to participants at 1, 3, 6 weeks, 12, 24 and 60 months. ii) Clinical data collected at the individual hospital centres using, where necessary, hospital based records and hardcopy CRF forms at the time of surgery and at 6-week clinical follow-up. These clinical data are then input into the eTHoS database by local researchers using an electronic web-based data capture system. Extensive range and consistency checks enhance the quality of the data. Staff in the Study Office will provide periodic data queries to local research staff to ensure that the data are as complete and accurate as possible. The additional relevant clinical data collected from routine data sources (HES & ISD) provide re-admission information related to haemorrhoids to evaluate long-term safety and the need for further haemorrhoid treatment to fulfil secondary clinical and economic outcomes and complete the overall objective of the trial. The data HSCIC provides will be used to compare effectiveness between the two surgical procedures and will not be used for any other purpose. Data will only be processed and stored at the stated location and accessed only for the purpose of this project and only by employees of the University of Aberdeen. No record level data with be shared with any third parties.

Objectives:

Haemorrhoids are a common problem and can be painful. The symptoms can be relieved by removing the haemorrhoids in an operation. There are two ways in which surgeons can remove haemorrhoids but not enough is known about how the methods compare. Currently, surgical treatment for haemorrhoids depends on the surgeon’s preference. The eTHoS trial is a pragmatic multicentre randomized controlled trial. The objective is to compare the two kinds of operations in order to inform surgeons about which operation is best for patients (in terms of patient quality of life, health economic and clinical outcomes). In order to achieve this objective, several areas of patient care and status will need to be considered. To enable accurate and reliable analysis, patient reported health status will be collected over the trial period from patient questionnaires as well as information on symptoms related to haemorrhoids, general health and complications from either procedure collected on clinical forms. Cost between surgeries will also be evaluated and in order to fully compare the overall clinical and economic costs, readmission data from Hospital Episode Statistics (HES) and Information Services Division (ISD) Scotland is required to quantify long-term safety and haemorrhoid reoccurrence. This in turn will be used to assess the full impact of on patients’ quality of life and enable an assessment of the overall costs to the NHS if, for example, one of the surgeries resulted in higher reoccurrences and further interventions to remove haemorrhoids. The results report which will be published on the HTA (Health Technology Assessment Programme, of the National Institute for Health Research) website which will be publically accessible and will inform patients, surgeons and other health care professionals about the clinical and cost effectiveness of the two major surgical haemorrhoid interventions being investigated and provide appropriate information to help NHS Trusts to base decisions on which treatments to offer.