NHS Digital Data Release Register - reformatted

Royal College of Psychiatrists

Project 1 — DARS-NIC-209200-S9H5R

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

Sensitive: Non Sensitive

When: 2020/06 — 2020/07.

Repeats: One-Off

Legal basis: National Health Service Act 2006 - s251 - 'Control of patient information'.

Categories: Anonymised - ICO code compliant

Datasets:

  • Mental Health Services Data Set

Objectives:

The National Clinical Audit of Psychosis (NCAP) is commissioned by the Healthcare Quality Improvement Partnership (HQIP) on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. The audit aims to provide those who commission, deliver and use services for people with psychosis with high quality data on the process and outcomes of NHS care. This agreement has Joint Data Controllership - consisting of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. The National Clinical Audit and Patient Outcomes Programme (NCAPOP) is a large programme of circa 35 projects consisting of National Clinical Audits and Confidential Enquiries. HQIP is commissioned by NHS England to commission and manage the NCAPOP. NHS England is a controller of the NCAPOP jointly with HQIP as together both organisations determine the purposes and means of processing. NHS England is responsible for determining which projects/topics are included as part of the NCAPOP. HQIP, as commissioner of the NCAPOP, is responsible for project specification development, procurement and extension activities, contract management and authorising data sharing requests. NHS England, as a funder of the NCAPOP, participates within specification development, procurement and project extension activities and authorises the publication of project outputs. NHS England is involved with developing the scope and purpose of the NCAPOP projects through participation within specification development activities and may authorise (as chair of the specification development meetings) the final project specifications. These specifications set out the purpose of the project, the patient groups and clinical services to evaluate and the types of data to collect. NHS England are a representative upon the HQIP Data access request group which authorises data sharing applications from third parties. The Royal College of Psychiatrists (RCPsych) are making an application for access to the Mental Health Services Data Set (MHSDS). This is to carry out a feasibility study into the use of routine data for the audit in the future. With the support of colleagues in NHS England and NHS Digital, RCPsych are aiming to move from a system that relies on clinical teams entering pseudonymous data onto bespoke online databases, to one that is based on secondary analysis of data that Trusts in England already submit to NHS Digital as part of the MHSDS. The feasibility study will involve checking the completeness and validity of data submitted to MHSDS against clinical data submitted directly to the audit team on a random sample of people with psychosis who are receiving care provided by an Early Intervention in Psychosis (EIP) team. This application requests that the Royal College of Psychiatrists (RCPsych) access data from the MHSDS to establish whether, in future years of the audit, it can move to a system that will be entirely based on secondary analysis of data already submitted to NHS Digital. At present audit data are collected in addition to routine data submitted to NHS Digital. This has been identified as a burden to services, taking resources away from clinical practice. By collecting matched audit data and comparing it to data submitted to MHSDS, RCPsych will undertake a formal test of reliability of the MHSDS for use in national clinical audit. The intention is that once the MHSDS are shown to be reliable data for use in national clinical audit and are proven to be a reliable indicator of performance against the National Institute for Health and Care excellence (NICE) quality standards, the audit will cease to collect bespoke data items. Over time the amount of data collected specifically for the audit will reduce and the audit will move towards reporting performance using MHSDS data submitted to NHS Digital i.e. using routinely collected data. This will reduce the burden of the audit on services and avoid replication of data collection, enabling resources to be concentrated on patient care. Legal Basis Justification: HQIP and NHS England both rely on the Article 6 (1) (e) legal basis under GDPR - "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". This is justified through commissioning arrangements which link back to NHS England and other national bodies with statutory responsibilities to improve quality of health care services. HQIP rely on Article 9 (2) (i) as the legal basis for processing under GDPR - "processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy". This is justified as all projects aim to drive improvements in the quality and safety of care and to improve outcomes for patients. NHS England rely on Article 9(2)(h) of the GDPR as the legal basis for processing. "Processing is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health or social care or treatment or the management of health or social care systems and services on the basis of Union or Member State law or pursuant to contract with a health professional and subject to the conditions and safeguards referred to in paragraph 3". NHS England are responsible for provision of health and social care, and management of systems and compliance. Although RCPsych have provided a process to opt-out of the audit, patients have not consented to data collected by Trusts as part of routine clinical practice being shared with us. Patients are people with mental health difficulties (including those who lack capacity to consent to care) and include the elderly, young people aged between 14 and 18 years old, and others who may be unable to consent (e.g. those with learning disabilities and other vulnerable groups). RCPsych have applied for and been granted Section 251 approval to collect identifiable data from Trusts for use in the feasibility study. The data being collected by the audit, and those requested from the MHSDS have been identified as necessary to assess the performance of Trusts against the audit standards. These are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard and were agreed by the NCAP Steering Group as necessary to assess quality of care. The data collected by RCPsych for the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams. RCPsych will therefore be able to compare the data in each dataset to undertake a formal test of reliability of the MHSDS for use in national clinical audit. NCAP is a three-year improvement programme which commenced in 2016 to increase the quality of care that NHS Mental Health Trusts in England and Health Boards in Wales provide to people with psychosis. Commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England, NCAP is the next phase in the development of the National Audit of Schizophrenia which took place 2011-2014. NCAP is a three year programme, currently commissioned until April 2020, with a possible two year extension, RCPsych have received provisional confirmation from HQIP that the contract will be renewed for the two year extension period. In 2019/2020 there are three projects: 1) The feasibility study, comparing data collected as part of the case-note audit with data from MHSDS. 2) Case-note audit, collecting data to analyse against the NCAP standards which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. 3) Service user survey, collecting information from people treated by EIP services to understand more about their experience of care. Once the contract is extended beyond April 2020, along with continuing to audit EIP services against agreed standards, RCPsych propose to examine the impact that the quality of care that people receive has on their future use of NHS services. This is important because current NICE recommendations are largely based on the results of clinical trials of interventions conducted among selected samples of patients. The impact that these interventions have when delivered in routine NHS practice is not known. Linking data from the audit with data on the use of inpatient and emergency medical services will enable RCPsych to investigate the impact that interventions such as Cognitive Behaviour Therapy for Psychosis and screening for risks of cardiovascular disease has on the health of people with psychosis. This information will help NICE, RCPsych and other organisations in the development of future guidelines that ensure that people with psychosis receive the interventions and treatments they need to achieve better physical and mental health. The MHSDS data RCPsych are seeking to access in this application will be used for the feasibility study. Patients aged 18 – 65 with First Episode Psychosis (FEP) on the caseload of an EIP team for 6 months or more on the census date (01/04/2019) and still on the caseload in June 2019 when the list of patients is submitted to the NCAP team for sampling. Maximum 100 patients per team (random sample identified by NCAP team) This application covers access to the MHSDS dataset for the cohort of patients included in the sample for the NCAP case-note audit 2019/2020, the maximum cohort size is 10560 and may be reduced if anyone who has opted out since the data was received from Trusts. The data collected by RCPsych in the case-note audit are the same as those submitted to MHSDS for patients on the caseload of EIP teams, allowing comparison of the datasets to test reliability. RCPsych will provide NHS Digital with the patient identifiers (NHS number, Postcode, Date of Birth, gender and NCAP ID) and NHS Digital will provide the MHSDS data including the NCAP ID as a pseudonymised file for this cohort back to RCPysch. The MHSDS data will be pseudonymised (the data will be returned to RCPsych with NCAP ID). This will allow RCPsych to compare the data to those collected for the case note audit. RCPsych need to do this at a patient-level, in order to understand the reliability of the MHSDS data. Data returned NHS Digital will include Year of birth, ethnicity, gender, employment status Data on treatment by EIP team: • Offer, referral, take up or refusal of Cognitive Behavioural Therapy for Psychosis • Offer, referral, take up or refusal of Family Intervention • Offer, take up or refusal of clozapine • Physical health screening o Comprehensive physical health assessment including screening of the following parameters within 12 weeks of acceptance on the caseload: Smoking status, lifestyle (incl. exercise, diet, alcohol and drug use), body mass index (BMI), blood pressure, glucose regulation (Glycated haemoglobin or HbA1c, Fasting plasma glucose, random plasma glucose), blood lipids (Total cholesterol measurement, Total cholesterol: HDL ratio measurement, non-HDL cholesterol, QRisk score – offer, take up or refusal o Repeat physical health assessment one year after the first assessment (+/- 6 weeks) of all parameters above – offer, take up or refusal o For anyone on the caseload for more than one year, annual comprehensive physical health assessment (all parameters above) carried out in the previous 12 months – offer, take up or refusal • Physical health interventions o Patients identified as needing an intervention (in the Lester Red Zone) as per screening above o Referral to another service for, or interventions offered, taken up or refused by those patients needing an intervention • Education and Employment Support offer, referral, take up or refusal • Carer-focused support offer, referral, take up or refusal • Outcome measures o Whether there are baseline and follow up scores for two or more outcome measures o Baseline and follow up scores for outcome measures (Health of the Nation Outcome Scales/ Health of the Nation Outcome Scales for Children and Adolescents, DIALOG (a Patient Reported Outcome Measure developed for people with psychosis), Process of Recovery Questionnaire, Other) RCPsych require MHSDS package 1d in order to cover all data collected by the audit. The MHSDS contains record level data about care of young people and adults who are in contact with mental health, learning disabilities or autism spectrum disorder services and Mental Health Services Mental Health services : Community is separated into 4 packages 1a. Community Activity Basic this extract will provide basis administrative data to support analysis of local level community activity. 1b Community Activity plus clinical detail – everything in 1a plus clinical information diagnoses, interventions, assessments – recorded using clinical terminology, including SNOMED 1c. Community Activity plus patient details – everything on 1 plus information about the patients being treated and the care coordination and care plan arrangements 1d. Community Activity – admin data, clinical data demographics in one package. RCPsych are requesting data from 01 November 2016 – 31 October 2019. This is because some interventions (ie Cognitive Behavioural Therapy for Psychosis) may have been provided when the person was first taken onto the caseload of the EIP service. People will have been on the caseload for up to 3 years at the end of data collection (31 October 2019). Data is requested for the cohort which comes from all EIP teams in England. In future years of the audit, it may be possible for some Trusts to use data submitted to MHSDS rather than having to submit separate data to the audit, where the feasibility study shows that the data submitted to MHSDS is shown to be reliable enough for analysis against the audit standards. The feasibility study is the only way to determine the reliability of the data for audit purposes. This was agreed following a preparatory meeting to discuss the form of the NCAP EIP audit with stakeholders from NHS England, NHS Digital, clinicians from EIP services and HQIP, and HQIP’s contract with RCPsych was amended accordingly. RCPsych thoroughly reviewed the options as part of the process for Section 251 approval, and this was deemed the best way to assess the reliability of the use of MHSDS in clinical audit. RCPsych asked NHS Digital if it would be possible to just receive those items from the MHSDS needed for the feasibility study, however were informed that it was only possible to receive the full packages. As the data required spans clinical information on assessments and interventions, patient details (including demographics and employment status). The MHSDS for patients on the caseload of EIP teams includes the same data as those collected by RCPsych for the case-note audit. These are the data required by the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych are requesting the MHSDS dataset, package 1d, from October 2016 – October 2019 (the period covered by the case-note audit). This is the minimum dataset required to compare with the data collected for the NCAP EIP audit in 2019/2020. It is not possible to use anonymous data. RCPsych need to ensure that RCPsych are comparing the data submitted for the audit to those held in the MHSDS for each patient. RCPsych are requesting MHSDS data from 01 November 2016 onwards. This is because most questions in the case-note audit relate to care provided to the patient during their time on the caseload of the EIP team. The recommended commissioned time for someone to receive treatment by an EIP team is 36 months. The audit collects data on interventions carried out until 31 October 2019, so people may have received relevant interventions from 01 November 2016 and RCPsych need information on all interventions provided to accurately compare the data. The cohort includes up to 100 patients for each of the 154 EIP teams in England. This is those patients included in the sample for the case-note audit and for whom RCPsych have collected audit data. The cohort is from teams across England. This is because the reliability of MHSDS data will vary between Trusts, and it’s important to understand how each trust performs. The cohort are limited to those aged from 18 – 65 years, as these are the age range treated by EIP teams and included in the sample. The data are limited to people being treated by EIP teams. RCPsych require all those episodes related to their treatment by or referrals made for them by EIP teams. RCPsych would need to know if people were pregnant or gave birth within 6 weeks of 31/10/2019 as this affects whether the audit collects a record of weight and information about glucose. RCPsych would not require the unborn child or neonatal records. RCPsych have requested data from 01 November 2016 to 31 October 2019. This is because questions in the case-note audit relate to care provided to the patient during their time on the caseload of the EIP team. The recommended commissioned time for someone to receive treatment by an EIP team is 36 months. The audit collects data on interventions carried out until 31 October 2019, so people may have received relevant interventions from 01 November 2016. RCPsych need those fields related to their treatment by EIP teams in regard to the NCAP audit standards, which are based on the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych have been advised that the MHSDS data is only available as a package – RCPsych require 1d in order to cover all data The collected by the audit, which includes clinical information on assessments and interventions and patient details (including demographics and employment status). RCPsych are providing identifiable data and NCAP ID (study ID) to NHS Digital, but do not require identifiable data to be returned with the MHSDS file. Instead, the data will be provided in a pseudonymised file with the NCAP ID. RCPsych are only requesting the MHSDS data for the cohort. This agreement has Joint Data Controller’s of the Healthcare Quality Improvement Partnership (HQIP) and NHS England. NCAP is commissioned by the Healthcare Quality Improvement Partnership on behalf of NHS England as part of the Clinical Audit and Patient Outcomes Programme. Representatives from NHS England and HQIP sit on the NCAP advisory board; RCPsych also have regular contract review meetings with HQIP. The Data Processor is the Royal College of Psychiatrists (RCPsych). RCPsych has sub-contracts for data processing with Formic Ltd (who provide the software used to collect audit data from providers) and Azure (who provide the secure server where RCPsych will be storing identifiable data). The NCAP Steering Group acts as an advisory group and provides advice and guidance on: • Final formulation of the audit standards, taken from the NICE and other relevant, evidence-based guidelines. • Measurement tools and approaches that are most appropriate for measuring practice and outcomes against the audit standards. • Marketing and promotion to ensure maximum sign-up to the audit and dissemination of the findings. • Amendments and development of audit methodology. • Interpretation and reporting of the audit data and findings. • Recommendations from the audit to improve practice. • Follow-up work between iterations of the audit The Steering Group meets twice yearly and includes representatives from the following organisations, as well as experts by experience and local audit representatives: British Psychological Society; Care Quality Commission; Early Intervention in Psychosis Network, Healthcare Quality Improvement Partnership (HQIP), NHS England, Welsh Government, Royal College of Nursing, Rethink Mental Illness, National Collaborating Centre for Mental Health, Royal College of General practitioners, Rethink Mental Illness are also contracted to provide advisory services and services related to service user engagement, including the production of a lay audit report.

Expected Benefits:

At present audit data are collected in addition to routine data submitted to NHS Digital. This has been identified as a burden to services, taking resources away from clinical practice. By collecting matched audit data and comparing it to data submitted to MHSDS, RCPsych will undertake a formal test of reliability of the MHSDS for use in national clinical audit, providing NHS England with clear provider-level information on the reliability of the MHSDS for each element of the data currently collected as part of the case-note audit. The intention is that once the MHSDS are shown to be reliable data for use in national clinical audit and are proven to be a reliable indicator of performance against NICE quality standards, the audit will cease to collect bespoke data items. Over time the amount of data collected specifically for the audit will reduce and the audit will move towards reporting performance using MHSDS data submitted to NHS Digital i.e. using routinely collected data. Until the comparison has been completed, it is unclear how quickly routinely collected data may replace the bespoke data items. However, moving to using routinely collected data will reduce the burden of the audit on services and avoid replication of data collection, enabling resources to be concentrated on patient care. Accessing patient identifiable information will also allow the project team to examine the relationship between the quality of care that people receive and their future use of NHS services. This is important because current NICE recommendations are largely based on the results of clinical trials of interventions conducted among selected samples of patients. The impact that these interventions have when delivered in routine NHS practice is not known. Linking data from the audit with data on the use of inpatient and emergency medical services will enable us to investigate the impact that interventions such as Cognitive Behaviour Therapy for Psychosis and screening for risks of cardiovascular disease has on the health of people with psychosis. This information will help NICE, RCPsych and other organisations in the development of future guidelines that ensure that people with psychosis receive the interventions and treatments they need to achieve better physical and mental health.

Outputs:

A feasibility report will be produced for NHS England and will include the results of the comparison of the MHSDS data with the audit data and recommendations on the degree of reliability necessary for future use of the MHSDS in clinical audit. It will present aggregate data with small numbers suppressed in line with NHS Digital Guidance. Anonymised record level comparisons may be made available if more detailed information is required on any elements (i.e. it might be that some areas of data are found to be more reliable than others and so could be used in the audit in the future, while Trusts continue to submit separate case-note audit data in other areas). At present this is the only communication planned. However, NHS England may want to engage with Trusts using the results of the feasibility report in order to encourage submission of complete data to MHSDS with the goal to move away from separate submission of case-note audit in the future. NCAP will support this as required. For example, RCPsych have previously presented to EIP regional groups on the results of the audit, and the NCAP clinical advisor presented in an NHS England webinar. This report is due to be provided to HQIP by the end of the current contract, 30 April 2020. It is not expected that the MHSDS data be used for anything except carrying out the feasibility study.

Processing:

RCPsych will provide NHS Digital with the patient identifiers (NHS number, Postcode, Date of birth, Gender and NCAP ID) for all patients in the cohort. NHS Digital will use the identifiable data to provide MHSDS data for all patients in the cohort. This includes personal information and sensitive data including health data and will be provided as a pseudonymous file including the NCAP ID to RCPsych. RCPsych will use the data provided by NHS Digital to compare with a pseudonymised version of the case-note audit data provided by Trusts. Analysis will be carried out within the NCAP team. Data will be patient-level throughout. Data submitted by Trusts to RCPsych will be identifiable; data on the cohort submitted by RCPsych to NHS Digital will be identifiable. RCPsych will create a pseudonymised version of the case-note audit data set on which data cleaning will be carried out; NHS Digital will provide a pseudonymised version of the MHSDS. Comparison will be made between the pseudonymised datasets. The MHSDS data received will not be matched with the identifiable data. Providers submit identifiable data on all patients in the sample to RCPsych via Formic survey software. RCPsych accesses the data by downloading it to the Azure secure server. During the data submission period (01 – 29 November), RCPsych uses the file to send a weekly update on number of returns to each provider. At the end of data submission, a final version of the file is downloaded to the Azure secure server. RCPsych create a file of patients identifiers (NHS Number, Postcode, Date of Birth, Gender) and NCAP ID which RCPsych send to NHS Digital to allow them to identify the cohort and return a pseudonymised version of the MHSDS with NCAP ID. RCPsych create a pseudonymised version of the case-note audit file, which is downloaded to the RCPsych servers. NCAP team carry out data cleaning with providers to create a final cleaned dataset. This will not be re-linked to the identifiable data – the final case-note audit dataset will remain pseudonymised. NCAP team carry out analysis of the final cleaned case-note audit dataset to create the national and local reports. NCAP team extract relevant information from the MHSDS dataset in order to link the MHSDS data provided by NHS Digital with the case-note audit data. Only the NCAP ID and no identifiable data will be used for this linkage, minimising the risk of re identification. NCAP team (following the advice of the statistician as required) carry out analysis to compare the data in the MHSDS with those in the case-note audit and write the feasibility report. The Mental Health Services Data Set (MHSDS) for patients on the caseload of Early Intervention in Psychosis (EIP) teams includes the same data as those collected by Royal College of Psychiatrists (RCPsych) for the case-note audit. These are the data required by the 2016 Early Intervention in Psychosis Access and Waiting Time Standard. RCPsych are requesting the MHSDS dataset, package 1d, from October 2016 – October 2019 (the period covered by the case-note audit). This is the minimum dataset required to compare with the data collected for the National Clinical Audit of Psychosis (NCAP) EIP audit in 2019/2020.