NHS Digital Data Release Register - reformatted
University of East Anglia
Project 1 — DARS-NIC-195235-Q0B5T
Opt outs honoured: No - data flow is not identifiable (Consent (Reasonable Expectation))
Sensitive: Non Sensitive
When: 2019/09 — 2019/09.
Legal basis: Health and Social Care Act 2012 – s261(1) and s261(2)(b)(ii)
Categories: Anonymised - ICO code compliant
- Hospital Episode Statistics Admitted Patient Care
- Hospital Episode Statistics Accident and Emergency
- Hospital Episode Statistics Outpatients
1) Purpose of the data request: The specific purpose of this data request is to monitor number of hospital admissions, A&E visits, outpatient visits, and ambulance call outs for participants recruited to the Falls in Care Homes (FinCH) randomised controlled trial. The FinCH trial is sponsored by University of Nottingham and the Principle Investigator is based at the University of Nottingham, with analysis completed at University of East Anglia. It is the largest randomised controlled trial (RCT) conducted in UK care homes to date, and having access to detailed health service use for 1,661 residents will be a valuable resource to better understand this population. It covers England only. Unit costs will be allocated for each participant, for inclusion in a cost-effectiveness analysis of the falls prevention intervention compared to usual care. Cost per participant will be presented in aggregated form (comparing the two treatment arms) as opposed to at individual or record level. Where possible, the study has collected resource use data from care home records, however information care homes document about secondary care lacks sufficient detail to allow accurate costing. The data requested here will build a more precise picture of the participants resource use during the trial follow-up period of 12 months. 2) Legal basis: Processing shall be lawful as both Article 6 1(e) and 9 2(j) of the General Data Protection Legislation apply. Article 6 1(e) applies, processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. The NIHR HTA FinCH trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The results of the research may inform public guidance and decisions about funding for care home fall prevention programmes and as such may help improve the health and well-being of care home residents in future. Processing shall be lawful as article 9(2)(j) applies - ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes…’ of Regulations (EU) 2016/679, April 27th 2016. The trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The data will not be used for commercial purposes, will not be provided in record level to any third party, and will not be not used for direct marketing. All analysis will be conducted at University of East Anglia, Norwich, UK. The FinCH trial also has the consent of participants and consultees in order to meet common law, that is the individual has given clear consent for the research team to process their personal data for a specific purpose. This is evidenced in the patient consent form where individual participants or their consultee initial to show agreement to “I agree to hospital and social care information about me being requested from National Data providers such as the Health and Social Care Information Centre.” The individual or their consultee will have had chance to read about this in more detail in the patient information sheet prior to the consent process taking place. Participants are informed of their right to withdraw at any time from the study without this affecting their legal or medical rights. This is again detailed in both the consent form and participant information sheet. The PIS and consent forms were designed to meet the requirements for this vulnerable population. Feedback from PPI was to ensure that the documents were simple to read and understand, and contained the essential information to enable them to decide whether to participate or not. Although a proportion of care home residents have capacity, PPI, including family member of a care home resident and a Care Home Manager, as well as clinicians, recommended that the information provided to the resident was kept as simple as possible to cover the relevant areas of consent while avoiding confusion. Where the consultee has consented on behalf of the participant, the research is being undertaken under the Mental Capacity Act 2005. This Act provides a framework for decision making on behalf of adults aged over 16 who lack capacity to make decisions themselves, including decisions to take part in research, such as health research. Sections 30-33 of the Act provide lawful authority for research to be carried out involving people without capacity provided that the research has been approved by an appropriate body. An appropriate body is a Research Ethics Committee (RECs) recognised by the Secretary of State or Welsh Ministers, and some RECs have particular expertise and training in considering such applications. This research is approved by the Yorkshire & The Humber – Bradford Leeds Research Ethics Committee which, as noted on the Health Research Authority (HRA) website, has this expertise – committee flag “Research Involving Adults Lacking Capacity” (https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/yorkshire-and-humber-bradford-leeds/). Institutional consent was also sought to permit the study to be conducted within the care home, and as such the care home managers who are responsible for the use of their residents records were made aware of the purpose of the study including how their residents’ data would be used and consented to the study. 3) Background to the research/trial: The data requested will enable the research team to estimate the secondary care costs over the trial period for all participants in the study such that we can report a mean cost per participant that includes all types of NHS care not just those based in the community. This will enable a more accurate estimate of the cost effectiveness of the falls prevention intervention compared to usual care. This information will in turn help inform the evidence base used to decide which fall prevention interventions should be funded in the care home setting. The Falls in Care Homes (FinCH) study; A multi-centre cluster randomised controlled trial to evaluate the Guide to Action Care Home (GtACH) fall prevention programme in old age UK care homes was funded by a grant from the NIHR Health Technology Assessment Programme (HTA 13/115/29) for £1.8 million in 2014. The data requested is to be used in the economic evaluation which is nested within the FinCH clinical trial and will be reported alongside aggregated results in the NHIR journal monograph series and presented in peer-reviewed publications. The study recruited adult care homes and their residents from a broad geographical area in the UK, to capture a range of health and social contexts. The sample size of the study was 1308 residents (654 to intervention group and 654 to control group). Updated calculations were made to allow for a variation in cluster size and a smaller number of participants per care home. The updated calculation gives a recruitment target of 78 care homes and 1482 individuals. In total 87 homes and 1698 residents were consented. To have been eligible for inclusion in the trial long term care home residents must have provided informed consent or those without capacity to have informed consent from a relative/consultee who will provide advice on their behalf. Residents were excluded if they were in receipt of end of life care or in the home for short term care, respite care or for rehabilitation. Randomisation to intervention or control (usual care) was at the care home level. The intervention arm received the GtACH Intervention. The intervention involved care home staff completing the GtACH Tool with residents in a private area of the care home. The results were discussed with family, friends and other care home staff. Completed GtACH documentation was placed in the resident’s care records. The actions might have required changes within the care home, changes to residents’ personal care, referral to other services, or purchase of equipment. The actions were written in the GtACH documentation. The GtACH was completed ideally within four weeks of randomisation (and within two weeks of staff training being completed in the care home) for all trial participants in the care home. Actions were started immediately after the identification of risk. As part of GtACH training, re-assessment was undertaken if the participant developed a new medical or cognitive condition, if they fell, or every three- six months if there are no other changes. Those in the control group received the comparator of usual care, i.e. the care that was in place prior to the trial. More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf The aim of the FinCH trial is to determine the clinical and cost effectiveness of the GtACH for fall prevention in care homes compared to usual care. This is important as 415,000 people live in UK care homes. These facilities provide care either with or without registered nursing input and are referred to as care homes with or without nursing respectively. The majority of residents are aged over 80, have cognitive impairment, mobility problems and multiple medical conditions. Health and social care interventions may require modifications in order to work in the care home setting, either because of the configuration of disability and dependency amongst residents, or to work within the organisational setting of care homes. One area where interventions might require to be designed with care homes specifically in mind is in the field of falls prevention. Community falls prevention interventions reduce falls and risk of falls by 30%, but literature to date has found no conclusive reduction in falls in care homes. Care home specific research is scarce and the existing research is inconclusive. Current fall interventions rely on patient engagement and adherence to advice. These present difficulties in care homes, where 75% of residents are cognitively impaired and non-targeted interventions with cognitively impaired older adults have not been successful. At a rate of 2.5 falls per person, per year there are 160,000 falls per year in care home residents. In care homes, nearly one in ten people who fall sustain a fracture, one in five are admitted to hospital and one in five will die within a year due to a fall related injury. One third of the UK’s hip fractures occur in care home residents, which is devastating to residents and their carers, and costly to the NHS. Even when falls do not result in fractures, they frequently result in other forms of injury. They cause fear of falling which contributes to a cycle of functional decline and increasing dependency with associated care costs. The Guide to Action for Falls Prevention - Care Homes (GtACH) intervention aims to reduce fall rates by supporting care home staff to identify risk factors for falling pertinent for an individual and take action to reduce those risks. It was co-produced by a group of care home staff, clinicians, researchers, public, voluntary and social care organisations and includes care home staff training, support and documentation. With training, the GtACH takes on average 20 minutes to complete for each resident. Initial proof of concept work and a subsequent feasibility randomised controlled trial (RCT) have shown that GtACH is implementable and changes staff behaviour in line with gold standard practice. This study will determine whether the use of GtACH has an impact on clinical outcomes for care home residents that are at risk of falling. More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf 4) Data requirements: The data required is individual level data on the resource use of participants in the FinCH trial from the Hospital Episode Statistics (HES) Outpatients (OP), the Hospital Episode Statistics Admitted Patient Care (APC) and the Hospital Episode Statistics Accident and Emergency (A&E) in order to be able to cost their secondary care use over the trial period in order to see if mean cost in the intervention arm was different to that in the control arm. Identifiers will be provided to NHS Digital for linkage, but the data to be disseminated by NHS Digital will be pseudonymised. Data is requested for three periods (2016/17, 2017/18, and latest available(18/19)). The date range required is 1st August 2016 – 28th February 2019 to reflect the date’s recruitment into the trial and when 12 month follow-up completed. The geographical spread of the data requested reflects the locations of the care homes in the trial. There are no alternative ways of collecting this data which is less intrusive. The study team have collected resource use data pertaining to primary and community care from care home maintained records but secondary care is not adequately recorded in care home records to enable recourse use to be costed. The data is minimised in that it relates to the trial cohort only. In addition, the study team have taken on board the advice of data managers from NHS digital with respect to fields requested, and this is reflected in this agreement. 5) Organisations: There are two joint data controllers, reflecting the fact that the grant for the research was awarded to and managed by Nottingham University and that the University of East Anglia manage the day to day running of the trial via their Clinical trials unit and lead the health economic aspect of the grant. Some other organisations are involved in an advisory capacity only - Nottingham City Care NHS and participating care homes. University Hospitals of Leicester and University of Leicester no longer have any involvement in the trial. The NIHR HTA programme funded the research but play no further role. The data will not be used for commercial purposes or direct marketing. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide. All analysis will be conducted at University of East Anglia, Norwich, UK.
This research is important as 415,000 people live in UK care homes. The majority of residents are aged over 80, have cognitive impairment, mobility problems and multiple medical conditions. Community falls prevention interventions reduce falls and risk of falls by 30%, but literature to date has found no conclusive reduction in falls in care homes. Care home specific research is scarce and the existing research is inconclusive. Current fall interventions rely on patient engagement and adherence to advice. These present difficulties in care homes, where 75% of residents are cognitively impaired and non-targeted interventions with cognitively impaired older adults have not been successful. At a rate of 2.5 falls per person, per year there are 160,000 falls per year in care home residents. In care homes, nearly one in ten people who fall sustain a fracture, one in five are admitted to hospital and one in five will die within a year due to a fall related injury. One third of the UK's hip fractures occur in care home residents, which is devastating to residents and their carers, and costly to the NHS. Even when falls do not result in fractures, they frequently result in other forms of injury. They cause fear of falling which contributes to a cycle of functional decline and increasing dependency with associated care costs. The Guide to Action for Falls Prevention - Care Homes (GtACH) intervention aims to reduce fall rates by supporting care home staff to identify risk factors for falling pertinent for an individual and take action to reduce those risks. It was co-produced by a group of care home staff, clinicians, researchers, public, voluntary and social care organisations and includes care home staff training, support and documentation. With training, the GtACH takes on average 20 minutes to complete for each resident. Initial proof of concept work and a subsequent feasibility randomised controlled trial (RCT) have shown that GtACH is implementable and changes staff behaviour in line with gold standard practice. This study will determine whether the use of GtACH has an impact on clinical outcomes for care home residents that are at risk of falling and whether implementing the GTACH is likely to be cost effective. Any benefits of the intervention will be realised by residents, care homes staff, the NHS, and tax payers. Without HES data the research team will not know the true cost differential with and without the GTACH falls prevention programme and as such the true value for money of this intervention will be unknown meaning tax payers may not get value for money if the wrong decision is made with respect to funding this intervention. Therefore, the expected output from the trial will include an evidence based patient treatment programme for older people living in care homes who are at risk of falls. The programme will be supported by a comprehensive treatment manual and training programme. These will aid care home staff to build capacity in falls prevention and will benefit residents. The manual will have Intellectual Property rights but will be distributed freely to all NHS/social care/care home staff who are working in care homes. As such the manual will be written to identify the core skills needed to provide a falls prevention process in a care home and it will provide an evidence based risk assessment and action plan with practical activities that care home staff can implement. Publication of the results will enable decision makers to access the evidence to inform their decisions and ultimately benefit patients by reducing falls in a care home setting. The clinical trial will demonstrate whether the intervention results in less falls, less injuries and a reduced fear of falling in care home residents. Reducing falls will have a positive impact on care home staff, families and the NHS. By not falling residents will remain more active having an impact on mood and behaviour. These are areas that care home staff and family find very distressing and difficult to address. The impact on the NHS will be the formation of an evidence based training programme which will give falls experts the materials to train care home staff in small groups to use a systematic falls prevention process. There is an anticipated impact of lower fracture rates, admissions to hospital, calls to emergency ambulance, calls to GPs and community services. The costs for an admission with a fracture has been estimated. The 'Guide to Action to prevent falls in Care Homes' (GtACH) has been costed resident which for most residents would be a one off cost. The impact to research in care homes will be the relationships built between researchers and care home staff in 87 homes. This could lead to care homes joining the EnRICH network and taking part in future studies. The research team experienced this in our feasibility study: All six care homes have now joined the AHSN Falls Network. Care home residents will benefit from having a research project taking place in their homes as it has been recognised that environments where research takes place are more positive than those who do not. The specific benefit of the economic evaluation attached to FinCH is anticipated to be that the results of the trial help inform future resource allocation decisions about investment in falls prevention programmes in UK care homes. Organisations such as NICE may use the evidence to inform appraisals about falls prevention interventions.
The results of the economic evaluation conducted alongside FinCH will be presented in the HTA monograph published on NIHR journals, submitted for publication to peer reviewed journals and presented at academic conferences. The HTA monograph needs to be submitted by the end of August 2019 alongside the submission of peer reviewed publications. Though publications may be submitted after this date where they explore specific aspects of the work in more detail. The results of the trial will be reported first to all trial collaborators (i.e. University of East Anglia, University of Nottingham, Nottingham City Care NHS and patient/nursing home representatives). The main report will be drafted by members of the Trial Management Group, and the final version will be agreed by the Trial Steering Committee before submission for publication, on behalf of the collaboration. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All publications will be subject to the forthcoming FinCH publications protocol, which will explicitly stipulate the requirements for authorship of publications. Findings will be disseminated to academic audiences through publication in open access academic journals and presentations at academic conferences. Dissemination of findings will be prioritised to study participants (residents/care home staff) who will receive quarterly newsletter updates. At the end of active involvement participants will receive thank you letters. Oral/poster presentations and workshops at sponsor hosted events, community meetings and professional/stake holder/user conferences will be targeted. The study will be submitted by the end of August 2019 for publication in the NIHR Journals in due course. The study team will seek to disseminate in a way to support best practice. They will liaise with ProFouND (The Prevention of Falls Network for Dissemination) and EnRICH to identify potential research users, other researchers, policy makers, commissioners, clinicians, care home managers and staff, care home residents and relatives. One member of the research team is the lead for the programmes related to older people in Collaboration for Leadership in Applied Health Research and Care East Midlands and the East Midlands Academic Health Sciences Network which will enable dissemination through these regional and national networks and to prepare for subsequent adoption at pace and scale. Dissemination outputs will be tailored towards each group including peer reviewed journal articles, evidence summaries, briefing papers, video clips and a DVD. Media coverage will be sought in the form of local newspapers, television and radio outlets. This will be enabled further via connecting with the university’s specialist experts in information technology and communication departments. Requests will be sent to relevant agencies to feature the research project in their newsletters and websites. A study web page will feature on the University of Nottingham Rehabilitation and Ageing divisional website. The data will not be used for commercial or direct marketing purposes. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.
There are four stages to the data flow: 1) data extraction, 2) data aggregation, 3) data matching and 4) data linkage. 1) data extraction: The ten participating sites in the trial are responsible for providing the identifiers to Norwich Clinical Trial Unit (CTU) at the University of East Anglia (UEA) via a secure password protected database. The CTU will undertake data extraction and transfer Patient Identifiable data (PID) data consisting of FinCH trial ID, NHS number, name, date of birth and gender to NHS Digital's secure N3 portal so that the FinCH study ID can be matched to NHS HES APC, A&E and outpatient data by NHS Digital (no other organisations are involved in processing of the data) for the requested years. 2) data aggregation: 3rd party secure N3 portal at the CTU receives and aggregates PID files from the ten sites (FinCH care homes) including study ID (Data Aggregation). 3) data matching: NHS Digital receive PID for FinCH participants from 3rd party secure N3 portal, match PID with HES data and send pseudonymised HES data for FinCH patients to UEA for analysis (data matching stage). NHS Digital will then send the pseudonymised HES data for FinCH participants to UEA via the secure N3 portal for analysis. The data sent back to UEA need only have the FinCH ID attached. No other organisations are involved in processing of the data. To access the pseudonymised data individuals will have to have system access to the REDCap database, which is provided only after the individual signs a delegation log, countersigned by a PI and then a copy provided to the study team. 4) data linkage: Once NHS digital have linked the data and created the new datasets these will be returned to UEA via the same secure N3 portal. UEA will then merge the HES data from NHS Digital with FinCH trial data to create a final dataset for analysis. This will be done using the study ID and creating a pseudonymised dataset only. Once the data has flowed from UEA to NHS Digital and back again there will be no further flows of data between UEA and NHS digital. The FinCH trial store the trial data (which includes a study ID for each record) onto an electronic database using a secure web application called REDCap. Names and contact details for participants are kept separately on paper at each of the 10 research sites to ensure re-identification by a third party is not possible. No further linkage of the data is permitted, other than that already stated in this agreement. UEA will hold the identifiers and pseudonymised data separately, and permissions are set so that the statisticians analysing the pseudonymised data cannot access the identifiers. Re-identification is not permitted under this agreement. Under this agreement, data processing will only be carried out by substantive employees of the University of East Anglia, who have all undertaken training in data security and GDPR. 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 ie: employees, agents and contractors of the Data Recipient who may have access to that data). All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.
Project 2 — DARS-NIC-171083-Q8R4B
Opt outs honoured: Yes - patient objections upheld (Section 251)
When: 2018/10 — 2018/12.
Legal basis: Health and Social Care Act 2012 – s261(7)
- MRIS - Bespoke
The food poisoning bacteria Shiga-toxin E. coli (STEC) are a public health concern because of the severity of the infections caused. Evidence from outbreaks suggests that the transmission routes for STEC infection are evolving; for example, more outbreaks are now attributed to leafy vegetables as opposed to undercooked meat. Since a majority of infections in England are sporadic, case-control studies are the preferred method to determine risk factors for infections. However, the last case-control study on Shiga-toxin E. coli infections was performed in the late 90s; an update is urgently needed to reflect current causes of infection in England so better prevention strategies can be developed. The University of East Anglia (UEA) is leading a STEC case-control study, working with Public Health England. This study has been funded by the NIHR Health Protection Research Unit in Gastrointestinal Infections (HPRU GI) project grant. The overall aim of this award is to bring Universities together with Public Health England (PHE) to assist in protecting public health, with the HPRU GI branch exploring the causes and distribution of diarrheal disease in the population. This Unit also funds studies led by other universities. Therefore, UEA also have access, should they need it, to specialise advice from the other universities funded by the Unit. The other universities have no control over decisions regarding this study, and no access to data provided by NHS Digital. As UEA does not have a Patient and Public Involvement Group (PPI), the University of Liverpool does allow UEA to use their PPI Group. This agreement relates to the first part of this study only, which is led by PHE. For this purpose, PHE requires a list of 50,0001 randomly selected (by age bracket) individuals registered with a GP in England, along with their addresses and ages. This information provided by NHS Digital will serve as a database of potential healthy control participants for a case-control study investigating Shiga-toxin E. coli transmission pathways. PHE will send invitation letters and study information to those individuals provided by NHS Digital to seek their consent in participating in the study. For this purpose, only substantive employees of PHE will have access to the personally identifiable data provided by NHS Digital as they have the data security systems in place to deal with such data. No other organisation will have access to the personally identifiable data provided by NHS Digital. As part of routine surveillance, PHE collects questionnaires on potential transmission routes from all confirmed cases of STEC in England and Wales. PHE will be providing a pseudonymised dataset of all STEC cases during the study period, ending March 31st 2019, to UEA. In order to determine which potential transmission routes are associated with acquiring STEC infections, then the questionnaires of cases need to be compared to questionnaires completed by healthy control participants. The database provided by NHS Digital to PHE will be used to recruit these control participants.
The benefit of receiving the database is that PHE will be able to recruit participants and successfully undertake the case-control study so that the research team can identify the most common sources for STEC infections and use this information to try and reduce the number of infections that occur per year in England.
The output from receiving the database, and therefore for this agreement, will be PHE contacting potential control participants to invite them to participate in the case-control study. For the analysis of the completed study (which goes beyond the remit of this agreement) all results will be reported at an aggregate level, with no reference to any individual data, as odds ratios for different risk factors associated with STEC infection. Once analysis is completed, a summary of results for the general public will be produced. This will be sent to any control participants that indicated in their consent form that they would like to be informed of any results and it will also be published on the NIHR Health Protection Research Unit in Gastrointestinal Infections website (hprugi.nihr.ac.uk). A peer reviewed research article on the study will also be produced for publishing in an Epidemiology journal. The results will also be presented at conferences, such as the HPRU GI annual conference, Public Health England’s Applied Epidemiology conference and at the International symposium for Shiga-toxin E. coli infections. PHE hope to have a draft of the research article prepared within one year of completion of the study, so by March 2020.
NHS Digital will provide the lead researcher at Public Health England with a database containing the names, ages, and addresses of 50,001 individuals, aged 0-70 years, that are resident in England and registered with a GP. This will be stored on password protected PHE computers and will only be accessed by the research team at PHE authorised to work on the case-control study. They will access the database to print out addresses on envelopes and include names on information packets to invite people to participate as controls in our study. PHE would then post out the questionnaires. UEA will only process data provided by the individuals who have directly responded. They will not process any data provided by NHS Digital. This agreement relates to the above part of the study only. However, in order to make clear the broader context for this, details of the study processing as a whole are described below. If someone from the database decides to participate, they will sign a consent form for University of East Anglia (UEA) to hold their data as provided by the questionnaire. The invitation letter will ask them to ensure they can be considered a “healthy” participant by the design of the study. The questionnaire will also ask them to provide their age and post code again, so that no personal information is being passed from PHE to UEA. The completed questionnaires will be returned to UEA for entry into a database of control subjects for the eventual analysis of the study. The case-control study will run for a period of a year, potentially collecting up to 1,000 cases if current trends for STEC infections are maintained. The study proposes to recruit 2 controls for every case, meaning PHE will need up to 2,000 controls. Recently, a similar case-control study was performed by the University of Liverpool investigating Campylobacter infections. Based on their response rate of 4% for control participants, PHE will need to be provided 50,001 names and addresses to ensure that UAE are able to recruit the 2,000 controls. PHE are age-frequency matching controls to cases, and the following numbers have been determined using data from STEC infections for the past 10 years. RANGES # to request 0-4 10455 5-9 5373 10-19 6341 20-29 9487 30-49 9971 50-70 8374 This is a mass mail out approach to 50,001 individuals asking them to consent to take part in the study. PHE will need the name, age, and address of all individuals provided so that they can invite those that are within the range of cases and write to them with the invitation packet at their address. The case-control study is for all of England, so there is no way to geographically restrict data in this manner. Furthermore, they will attempt to recruit up until the end of the study, on March 31st for 2019, and the data will be retained until March 2020. During the study, however, data will be deleted when this is requested by responders, and the information of non-responders will be deleted if they have not responded after the second contact attempt. Furthermore, the data of individuals that respond after 2,000 questionnaires have been received will be deleted from the database.
Project 3 — DARS-NIC-148298-N5HDR
Opt outs honoured: N
Sensitive: Sensitive, and Non Sensitive
When: 2016/04 (or before) — 2016/11.
Legal basis: Informed Patient consent to permit the receipt, processing and release of data by the HSCIC
- MRIS - Cause of Death Report
- MRIS - Cohort Event Notification Report
Study Hypothesis The primary research question is whether a community based screening program for osteoporosis reduces, and is cost-effective in reducing, the incidence of fractures in older women. Questions to be addressed in the feasibility study 1) Can sufficient GPs be recruited to the study to allow access to the number of women required for a successful main study? 2) What is the rate of uptake amongst those women invited to take part in the study? 3) What are the characteristics of those accepting the invitation to join the study and what percentage are excluded (based on stated exclusion criteria) ? 4) What are the completion rates for the baseline questionnaires? 5) What proportion of women in the intervention group will be assigned to different categories of risk (i.e. low risk, intermediate risk, high risk)? 6) What proportion of intermediate risk cases will attend for a BMD scan? 7) What proportion of the control group will commence therapy after enrolment ? 8) What proportion of the intervention group will follow the suggested management pathway? 9) What proportion of the intervention group will adhere to the suggested management pathway and be compliant with therapy at 6 months?