Emergency Surgery Or noT (the ESORT study)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Objective for processing

This is an extension application for pseudonymised Civil Registration data and Hospital Episode Statistics (HES) data; for the purpose of an observational study, which will provide a rigorous evaluation of the relative effectiveness and costs of emergency surgery versus non-operative care for common acute conditions and inform change to emergency general surgery provision across the NHS. Patients with acute conditions who present as emergency hospital admissions may receive [34 words unchanged] benefits, risks and costs of emergency surgery versus non-operative care are unknown. [2 paragraphs unchanged] London School of Hygiene & Tropical Medicine (LSHTM) is the data controller under this Agreement and has previously obtained HES and Civil Registration (Deaths) data for this study for use in the “Emergency Surgery Or noT (ESORT)” study activities. The LSHTM instigated the work in order to estimate the effectiveness and [14 words unchanged] as emergency admissions to NHS trust hospitals. University of Pennsylvania is a co-applicant partner organisation who provides expertise on instrumental variable approaches and led a related study [21 words unchanged] will have access to the pseudonymised data requested and supplied by NHS Digital. England. Data will not flow to international partners who will only act in an advisory capacity. Funding for the study is from the NIHR HS&DR DR (National Institute for Health Research Health and Social Care Delivery Research) programme and a linked PhD studentship funded by the NIHR Applied Research Collaboration North Thames. Additional funding from NIHR HS&DR was obtained for work on multimorbidity subgroups in the ESORT study. Further funding is being sought from NIHR ARC North Thames (as part of the 18-month funding extensions awarded to ARCs from October 2024-March 2026) to extend the work from the completed PhD to multimorbidity subgroups. The NIHR have no role in decisions made over the processing or analysis methodology of the data in this study. A PPI patient and public involvement (PPI) group has informed the design of the study through the involvement of [18 words unchanged] public in general when someone arrives at a hospital in an emergency. [1 paragraph unchanged] Under the original Agreement (v0) the data was minimised by requesting only those who meet the criteria for the analysis (ICD-10 codes) analysis. This was via the ICD-10 codes of patients with an emergency admission which included one of seven acute conditions [76 words unchanged] the remaining five were retained following assessment by a clinical panel. Therefore as amended under this Agreement v1 of the agreement, there are were now only 5 acute conditions included: appendicitis, gallstones, diverticulitis, hernia and intestinal obstruction. The data requested has been was minimised respectively. Additionally, the admission dates have been were extended from 31 March 2018 to 30 June 2020. 2020 (this occurred under v1 of the agreement). This observational study will provide a rigorous evaluation of the relative effectiveness and costs of emergency surgery versus non-operative care for common acute conditions, and inform change to emergency general surgery provision across the NHS. The specific objectives are to evaluate using HES Admitted Patient Care (APC), HES Critical Care (CC) and Civil Registration (Deaths) - Secondary Care Cut: Cut are: [3 paragraphs unchanged] Data previously requested: Data Requested under v0: [1 paragraph unchanged] Data Requested in this the previous Amended Agreement (v1): - Resupply of Pseudonymised record level HES APC data 2008/09, 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, and 2016/17 linked to latest Civil Registration (Deaths) - Secondary Care Cut*, Cut with full date of death, and - Pseudonymised record level HES APC data annual refreshes for the years [11 words unchanged] to be M08) linked to Latest Civil Registration (Deaths) – Secondary Care Cut*, Cut with full date of death, and - Pseudonymised record level HES CC data annual refreshes for the years [6 words unchanged] 2014/15, 2015/16, 2016/17, 2017/18, 2018/19, 2019/20, plus the latest available data for 2020/21 (estimated to be M08). 2020/21. All adult patients (18 years +) with an emergency admission which includes [28 words unchanged] or episode end date between 1 April 2009 and 30 June 2020. * In a future amendment to this Agreement further periods of data will be requested up until end of June 2021 to include data up until 12 months after the last admission date. HES APC, HES CC and Civil Registration (Deaths) - Secondary Care Cut data are required from NHS Digital in order to undertake this study. Overall justification of the data requested: [10 paragraphs unchanged] LSHTM are also requesting requested data on a very limited number of variables relating to all episodes [84 words unchanged] is undertaken (the tendency to operate, subsequently used as an instrumental variable). [2 paragraphs unchanged] Under previous iterations of this Agreement: Rather than applying to access death dates from the Civil Registration (Deaths) data set, the controller originally requested derived variables indicating, for each patient in the cohort, whether or not they had died by 30-days, 90-days and 1-year after their index admission. This removed the need for LSHTM to directly access this sensitive data from the Civil Registration (Deaths) data set. Rather than applying to access death dates from the Civil Registration (Deaths) data set, the data controller requested derived variables indicating, for each patient in the cohort, whether or not they had died by 30-days, 90-days and 1-year after their index admission. This removed the need for them to directly access this sensitive data from the Civil Registration (Deaths) data set. Full date of death (rather than 30/90/365 mortality flags) has since been requested and disseminated (under version 1.5 of this agreement) and is currently held. Date of death is required for two reasons: (i) deriving a primary outcome, and (ii) allocation to the emergency surgery or conservative management arm. The study's PPI meetings discussed potential outcomes and highlighted 'days alive and out of hospital' as an important outcome. Accurate measurement of this outcome requires date of death. The second reason for requiring date of death is to enable an allowance to be made in the analysis for immortality bias. This relates to the use of a time window within which surgery must occur (e.g. 7 days) to be defined as 'emergency surgery' and the possibility that a patient may die without having surgery during this window. Date of death will allow the study to identify these patients for each day in the window. Under this amended Agreement The lawful basis for processing personal data under the UK GDPR is: Date of death (rather than 30/90/365 mortality flags) is required for two reasons: (i) deriving a primary outcome, and (ii) allocation to the emergency surgery or conservative management arm. The study's patient and public involvement (PPI) meetings discussed potential outcomes and highlighted 'days alive and out of hospital' as an important outcome. Accurate measurement of this outcome requires date of death. The second reason for requiring date of death is to enable an allowance to be made in the analysis for immortality bias. This relates to the use of a time window within which surgery must occur (e.g. 7 days) to be defined as 'emergency surgery' and the possibility that a patient may die without having surgery during this window. Date of death will allow the study to identify these patients for each day in the window. Article 6(1)(e) - 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 General Data Protection Regulation Article 6 (1) (e) and Article 9 (2) (j) are the legal basis for the processing of the data. The London School of Hygiene and Tropical Medicine is a public authority as described under Schedule 1 of the FOI Act 2000 and has a basis in law for Lawfulness of processing as they have a Royal Charter. - Article 6(1)(e) Task in the public interest: The London School of Hygiene and Tropical Medicine is a public authority as described under Schedule 1 of the FOI Act 2000 and has a basis in law for Lawfulness of processing as they have a Royal Charter. The lawful basis for processing special category data under the UK GDPR is: - Article 9(2)(j) Archiving in the public interest/scientific or historical research/statistical purposes: The data are required for research purposes in the public interest meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data, demonstrated in the Purpose sections below. Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

Processing activities

[1 paragraph unchanged] 1. NHS Digital England provide the LSHTM with bespoke data extracts of HES APC episodes linked to mortality data, and HES CC episodes including the Unique Study ID and no other identifiers. [3 paragraphs unchanged] 5. A single patient-level data set for each condition will be created [16 words unchanged] data will be used or linked to the data provided by NHS Digital. England. LSHTM will store the data on a secure server in London which [46 words unchanged] substantive employees. No elements of the work will take place outside the UK. England/Wales. LSHTM staff and students are only granted access to the secure server [8 words unchanged] training within the previous 12 months. This is a requirement of LSHTM's IG Data Security and Protection Toolkit. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract - i.e. employees, agents and contractors of the Data Recipient who may have access to that data). The Data will be accessed by authorised personnel via remote access. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. For remote access: - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; - Access controls granting users the minimum level of access required are in place; - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - Multifactor authentication (MFA) is required for remote access; - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). [13 paragraphs unchanged] HES DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, LSHTM must make sure that: · cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table. · Zeros (0) do not need to be suppressed. · All other counts will be rounded to the nearest 5. [1 paragraph unchanged]

Expected output

The original aim is was to complete the study by September 2022, with all the below outputs scheduled between approximately September 2020 and April 2023. This was achieved for both the NIHR-funded ESORT study and the NIHR-funded (North Thames ARC) PhD, see outputs listed below. Additional funding for ESORT was secured from NIHR to focus on patient subgroups with multiple long-term conditions. [3 paragraphs unchanged] The LSHTM hosted two virtual PPI panels in July 2020, at followed by 2 more in 2021. At which they spoke with members of the public and former patients about our the study. This included discussion about what outcomes are important, such as simply [54 words unchanged] experiences behind the information that they are collecting from hospital medical records. LSHTM will invite the PPI Panel members to return towards the end of the project in 2021, to provide their insights once they have the preliminary findings from the study. [2 paragraphs unchanged] Further planned output will be on the effectiveness of surgery in multi-morbid and other subgroups and is supported by additional funding for ESORT from NIHR. This will comprise two published outputs to be submitted in Autumn/Winter 2023. The first, a methodological paper, was submitted on 1/10/23. The second, an empirical paper will also be submitted in the Winter. The request for a 2-year extension to the DSA allows for an upper estimate of 21 months for responding to peer review requests and post-publication letters as part of the publication process. If the application for NIHR funding from ARC North Thames is successful then the team would expect one or two more publications on applied and methodological findings to be submitted in Autumn/Winter 2025. Outputs to date are in line with plans and are as follows: Grieve R, Hutchings A, Zapata SM et al. Clinical effectiveness and cost-effectiveness of emergency surgery for adult emergency hospital admissions with common acute gastrointestinal conditions: the ESORT study. Health and Social Care Delivery Research, 2023 11(1) Moler-Zapata S, Grieve R, Basu A, O’Neill S. How does a local instrumental variable method perform across settings with instruments of differing strengths? A simulation study and an evaluation of emergency surgery. Health Economics 2023 epub ahead of print https://doi.org/10.1002/hec.4719 Moler-Zapata S, Hutchings A, O'Neill S, Silverwood RJ, Grieve R. Emulating Target Trials with Real-World Data to Inform Health Technology Assessment: Findings and Lessons from an Application to Emergency Surgery. Value in Health 2023 epub ahead of print doi.org/10.1016/j.jval.2023.04.010 Snowdon C, Silver E, Charlton P et al. Adapting Patient and Public Involvement processes in response to the Covid-19 pandemic. Health Expectations 2023;26(4):1658–67 Moler-Zapata S, Grieve R, Lugo-Palacios D, Hinchliffe R, O’Neill, S. Local Instrumental Variable Methods to Address Confounding and Heterogeneity when Using Electronic Health Records: An Application to Emergency Surgery. Medical Decision Making 2022;42(8):1010-26 Hutchings A, O’Neill S, Lugo-Palacios D et al. Effectiveness of emergency surgery for five common acute conditions: an instrumental variable analysis of a national routine database. Anaesthesia 2022; 77(8):865–81 Hutchings A, Moler Zapata S, O'Neill S et al. Variation in the rates of emergency surgery amongst emergency admissions to hospital for common acute conditions. BJS Open 2021;5(6):zrab094

Expected measurable benefits

[2 paragraphs unchanged] The current analyses are examining further subgroups to understand which particular multi-morbidity or other patient characteristic combinations contribute to the findings related to frailty and present this in a clinically meaningful way for clinicians and patients. The team anticipate measurable benefits in terms of greater use of alternatives to emergency surgery leading to better outcomes within two years of publication.

Benefits reported

There are no Yielded Benefits to date. The initial data provided by NHS England was used to develop and refine definitions of the cohorts and intervention (emergency surgery). This work was included in a section of the final report to the funders (published January 2023.) A planned protocol paper was not done and replaced by a paper describing the patient cohort and variation in emergency surgery rates (see Hutchings et al, BJS Open above). The initial data provided by NHS Digital have been used to develop and refine definitions of the cohorts and intervention (emergency surgery). This work will be included in a section of the final report to the funders (Autumn 2021) and will form the basis of a planned protocol paper to be drafted in Summer 2020 and submitted for publication. A key finding from the main analysis on the effectiveness of surgery showed that there was no evidence for an overall difference between emergency surgery and alternative strategies to emergency surgery in terms of outcomes. The analyses also looked at effectiveness of subgroups of patients and found a consistent benefit for alternatives to emergency surgery in patients categorised as very frail (see publications listed in outputs).

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Hospital Episode Statistics Critical Care (HES Critical Care)

Objective for processing

[3 paragraphs unchanged] London School of Hygiene & Tropical Medicine (LSHTM) requires is the data controller under this Agreement and has previously obtained HES and Civil Registration (Deaths) data for this study for use in the “Emergency Surgery Or noT (ESORT)” study activities. The LSHTM instigated the work in order to estimate the effectiveness and [9 words unchanged] with common acute conditions presenting as emergency admissions to NHS trust hospitals. No other organisations are involved. University of Pennsylvania is a co-applicant who provides expertise on instrumental variable approaches and led a related study using US data. Only LSHTM will determine the purpose for and the manner in which the data is processed. Only LSHTM will have access to the pseudonymised data requested and supplied by NHS Digital. Data will not flow to international partners who will only act in an advisory capacity. The LSHTM has applied for and secured funding from the NIHR to undertake this work. Funding for the study is from the NIHR HS&DR programme and a linked PhD studentship funded by the NIHR Applied Research Collaboration North Thames. The NIHR have no role in decisions made over the processing or analysis methodology of the data in this study. The aim of this work is to estimate the effectiveness and cost-effectiveness of emergency surgery versus non-operative care for patients with common acute conditions presenting as emergency admissions to NHS trust hospitals. The acute conditions being considered are appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction, acute intestinal ischaemia, and peptic ulcer’. This observational study will provide a rigorous evaluation of the relative effectiveness and costs of emergency surgery versus non-operative care for common acute conditions, and inform change to emergency general surgery provision across the NHS. The specific objectives are to evaluate using HES and Civil Registration (Deaths) data: A PPI group has informed the design of the study through the involvement of the co-investigator. This work seeks a clearer understanding of what is important for patients, their families and the public in general when someone arrives at a hospital in an emergency. The aim of this work is to estimate the effectiveness and cost-effectiveness of emergency surgery versus non-operative care for patients with common acute conditions presenting as emergency admissions to NHS trust hospitals. Under the original Agreement the data was minimised by requesting only those who meet the criteria for the analysis (ICD-10 codes) patients with an emergency admission which included one of seven acute conditions in any diagnosis of the first episode of the admission between 1 April 2009 and 31 March 2018. These conditions were appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction, acute intestinal ischaemia, and peptic ulcer. The initial phase of the research was to use HES data to establish the conditions for which cohorts of emergency admissions could be identified where there was equipoise with respect to emergency surgery. Following discussions at investigators' meetings two conditions were dropped and the remaining five were retained following assessment by a clinical panel. Therefore under this Agreement there are now only 5 acute conditions included: appendicitis, gallstones, diverticulitis, hernia and intestinal obstruction. The data requested has been minimised respectively. Additionally, the admission dates have been extended from 31 March 2018 to 30 June 2020. This observational study will provide a rigorous evaluation of the relative effectiveness and costs of emergency surgery versus non-operative care for common acute conditions, and inform change to emergency general surgery provision across the NHS. The specific objectives are to evaluate using HES Admitted Patient Care (APC), HES Critical Care (CC) and Civil Registration (Deaths) - Secondary Care Cut: [3 paragraphs unchanged] HES Admitted Patient Care (APC) and Civil Registration (Deaths) data are required from NHS Digital in order to undertake this study. Overall justification of the data requested: Data previously requested: HES APC data are required to determine the exposure (emergency surgery or non-operative care), to identify patient characteristics (age, sex, ethnicity, index of multiple deprivation) and comorbidities, to identify subsequent admissions (emergency or elective), to derive the surgical volume (a measure of quality) for each acute condition, and to derive and the proportion of emergency admissions for each acute condition where emergency surgery is undertaken (the tendency to operate, subsequently used as an instrumental variable). Civil Registration (Deaths) data are required so that 30-day, 90-day and 1-year mortality can be considered as outcomes. Pseudonymised record level HES APC data 2008/09, 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, and 2016/17 linked to Latest Civil Registration (Deaths) – Secondary Care Cut*. All adult patients (18 years +) with an emergency admission which includes a diagnosis (via ICD-10 code) of one of 7 acute conditions in any diagnosis field of the first or second episode of the admission, with an admission date or episode end date between 1 April 2009 and 31 March 2018. The number of years of data requested (2009-2016) will provide sufficient events for analysis without being an unduly long period. Data Requested in this Amended Agreement (v1): - Resupply of Pseudonymised record level HES APC data 2008/09, 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, and 2016/17 linked to latest Civil Registration (Deaths) - Secondary Care Cut*, and - Pseudonymised record level HES APC data annual refreshes for the years 2017/18, 2018/19, 2019/20 plus the latest available data for 2020/21 (estimated to be M08) linked to Latest Civil Registration (Deaths) – Secondary Care Cut*, and - Pseudonymised record level HES CC data annual refreshes for the years 2008/09, 2009/10, 2010/11, 2011/12, 2012/13, 2013/14, 2014/15, 2015/16, 2016/17, 2017/18, 2018/19, 2019/20, plus the latest available data for 2020/21 (estimated to be M08). All adult patients (18 years +) with an emergency admission which includes a diagnosis (via ICD-10 code) of one of 5 acute conditions in any diagnosis field of the first or second episode of the admission, with an admission date or episode end date between 1 April 2009 and 30 June 2020. * In a future amendment to this Agreement further periods of data will be requested up until end of June 2021 to include data up until 12 months after the last admission date. HES APC, HES CC and Civil Registration (Deaths) - Secondary Care Cut data are required from NHS Digital in order to undertake this study. Overall justification of the data requested: HES APC data are required to determine the exposure (emergency surgery or non-operative care), to identify patient characteristics (age, sex, ethnicity, index of multiple deprivation) and comorbidities, to identify subsequent admissions (emergency or elective), to derive the surgical volume (a measure of quality) for each acute condition, and to derive and the proportion of emergency admissions for each acute condition where emergency surgery is undertaken (the tendency to operate, subsequently used as an instrumental variable). HES APC and HES CC data are required for estimating resource use and costs associated with emergency surgery and non-operative care. [1 paragraph unchanged] The HES APC data being requested relate to: i) a specific cohort of patients (relating to the above 7 acute conditions only) and ii) a broader extract (relating to the above 7 acute conditions only) which will allow the LSHTM to assess the quality of care experienced by the patients in the cohort. The HES APC data being requested relate to: i) a specific cohort of adult patients (18 years+) relating to the above 5 acute conditions only, and ii) a broader extract of adult patients (18 years+) relating to the above 5 acute conditions only which will allow the LSHTM to assess the quality of care experienced by the patients in the cohort. [1 paragraph unchanged] The cohort of patients is defined as all adult patients with an emergency admission which includes a diagnosis (via ICD-10 code) of one of 7 5 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction, acute intestinal ischaemia, peptic ulcer) obstruction) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2009 and 31 March 2016. 30 June 2020. This is the index admission. LSHTM are requesting data relating to their [23 words unchanged] after their index admission (i.e. covering the period 1 April 2008 – 31 March 2017 30 June 2021 or latest available overall). Data at the index admission will be used to determine the [45 words unchanged] index admission will be used to identify subsequent admissions (emergency or elective). [1 paragraph unchanged] Exclusion criteria for defining the index admission will include: age less than 18, a previous emergency admission for the condition within the year prior to the index admission, referrals from tertiary referral centres. [1 paragraph unchanged] LSHTM are also requesting data on a very limited number of variables [8 words unchanged] and elective) which include a diagnosis (via ICD-10 code) of one of 7 5 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction, acute intestinal ischaemia, peptic ulcer) obstruction) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2008 and 31 March 2016 30 June 2020 (i.e. not just the cohort patients). These data will be used to [25 words unchanged] is undertaken (the tendency to operate, subsequently used as an instrumental variable). [2 paragraphs unchanged] Rather than applying to access death dates from the Civil Registration (Deaths) dataset, LSHTM are requesting derived variables indicating, for each patient in their cohort, whether or not they had died by 30-days, 90-days and 1-year after their index admission. This removes the need for them to directly access this sensitive data from the Civil Registration (Deaths) dataset. Under previous iterations of this Agreement: Rather than applying to access death dates from the Civil Registration (Deaths) data set, the data controller requested derived variables indicating, for each patient in the cohort, whether or not they had died by 30-days, 90-days and 1-year after their index admission. This removed the need for them to directly access this sensitive data from the Civil Registration (Deaths) data set. Under this amended Agreement Date of death (rather than 30/90/365 mortality flags) is required for two reasons: (i) deriving a primary outcome, and (ii) allocation to the emergency surgery or conservative management arm. The study's patient and public involvement (PPI) meetings discussed potential outcomes and highlighted 'days alive and out of hospital' as an important outcome. Accurate measurement of this outcome requires date of death. The second reason for requiring date of death is to enable an allowance to be made in the analysis for immortality bias. This relates to the use of a time window within which surgery must occur (e.g. 7 days) to be defined as 'emergency surgery' and the possibility that a patient may die without having surgery during this window. Date of death will allow the study to identify these patients for each day in the window. The General Data Protection Regulation Article 6 (1) (e) and Article 9 (2) (j) are the legal basis for the processing of the data. - Article 6(1)(e) Task in the public interest: The London School of Hygiene and Tropical Medicine is a public authority as described under Schedule 1 of the FOI Act 2000 and has a basis in law for Lawfulness of processing as they have a Royal Charter. - Article 9(2)(j) Archiving in the public interest/scientific or historical research/statistical purposes: The data are required for research purposes in the public interest meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data, demonstrated in the Purpose sections below.

Processing activities

[1 paragraph unchanged] 1. NHS Digital provide the LSHTM a with bespoke data extract extracts of HES Admitted Patient Care APC episodes linked to mortality data, and mortality data HES CC episodes including the Unique Study ID and no other identifiers. [3 paragraphs unchanged] 5. A single patient-level dataset data set for each condition will be created including the above derived variables. The main analysis will be on this these patient-level dataset. datasets. No other data will be used or linked to the data provided by NHS Digital. LSHTM will store the data on a secure server in London which can be only be accessed at LSHTM. No organisations other than LSHTM are involved in the planned data analysis. All those involved in the processing of the data are substantive employees of LSHTM or students on LSHTM MSc and doctorate courses under the supervision of LSHTM substantive employees. No elements of the work will take place outside the UK. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data). LSHTM staff and students are only granted access to the secure server if they have undergone Information Security and Awareness training within the previous 12 months. This is a requirement of LSHTM's IG Toolkit. All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract - i.e. employees, agents and contractors of the Data Recipient who may have access to that data). [1 paragraph unchanged] There will be no requirement nor attempt to reidentify re-identify individuals from the data. The data will not be made available to any third parties except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide. Only 5 specific conditions will be considered. Data relating to other conditions are not being requested. Only specific conditions will be considered. Data relating to other conditions are not being requested. [1 paragraph unchanged] DATA MINIMISATION: Civil Registration (Deaths) - Secondary Care Cut 1) All patients with an emergency admission which includes a diagnosis (via ICD-10 code) of one of 5 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2009 and 30 June 2020. 2) All episodes of all admissions (emergency and elective) which include a diagnosis (via ICD-10 code) of one of the above 5 acute conditions, with an admission date between 1 April 2008 and 30 June 2020. HES Admitted Patient Care 1) All patients with an emergency admission which includes a diagnosis (via ICD-10 code) of one of 5 acute conditions (appendicitis, gallstones, diverticulitis, hernia, intestinal obstruction) in any diagnosis field of any episode of the admission, with an admission date between 1 April 2009 and 30 June 2020. 2) All episodes of all admissions (emergency and elective) which include a diagnosis (via ICD-10 code) of one of the above 5 acute conditions, with an admission date between 1 April 2008 and 30 June 2020. Critical Care: Critical care data are only required for the cohort of emergency admissions between 1 April 2009 and 30 June 2020. HES DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, LSHTM must make sure that: · cell values from 1 to 7 are suppressed at a local level to prevent possible identification of individuals from small counts within the table. · Zeros (0) do not need to be suppressed. · All other counts will be rounded to the nearest 5. Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.

Expected output

The aim is to complete the study by April 2021, September 2022, with all the below outputs scheduled between April 2019 approximately September 2020 and April 2021 (exact dates TBC). 2023. Findings will be presented at national and international conferences including clinical (surgical, perioperative) and academic (Health Services and Health Economist) Economics) meetings. A translation workshop will draw on the views of patient representatives, [16 words unchanged] setting future research priorities, to ensure the study can inform service change. [2 paragraphs unchanged] The LSHTM hosted two virtual PPI panels in July 2020, at which they spoke with members of the public and former patients about our study. This included discussion about what outcomes are important, such as simply surviving the emergency, or how long someone stays in hospital, or if they are readmitted. The research team also discussed how to judge how people feel about their quality of life after experiencing going into hospital as an emergency. These views and insights will help the research team to understand more about the real-life experiences behind the information that they are collecting from hospital medical records. LSHTM will invite the PPI Panel members to return towards the end of the project in 2021, to provide their insights once they have the preliminary findings from the study. [2 paragraphs unchanged]

Expected measurable benefits

The aim is to complete the study by April 2021, with all the below measurable benefits scheduled between April 2019 and April 2021 (exact dates TBC). The actual expected benefits of the project are increased effectiveness and cost-effectiveness of emergency general surgery within the NHS. Increased effectiveness will lead to improved quality of care, survival rates and quality of life. Increased cost-effectiveness will enable commissioners/care providers to reallocate funding to other areas of care, benefiting care users. To help ensure that evidence will be generated that can improve emergency general surgery provision, the study design has been informed by service providers, commissioners and patient representatives. As well as a health economist, statisticians and an econometrician, the wider project team includes clinicians (senior perioperative researcher; consultant vascular surgeon; medical director) and a senior member of the Clinical Effectiveness Unit, Royal College of Surgeons, who will bring a national surgical perspective. The study will inform service change via a translation workshop which will draw on the views of patient representatives, surgeons, national policy makers (e.g. NICE, NHS England), commissioners and managers of surgical services and those setting future research priorities. The actual expected benefits of the project are increased effectiveness and cost-effectiveness of emergency general surgery within the NHS. Increased effectiveness will lead to improved quality of care, survival rates and quality of life. Increased cost-effectiveness will enable commissioners/care providers to reallocate funding to other areas of care, benefitting care users. [1 paragraph unchanged]

Benefits reported

Yielded Benefits is not a requirement for new applications. There are no Yielded Benefits to date. The initial data provided by NHS Digital have been used to develop and refine definitions of the cohorts and intervention (emergency surgery). This work will be included in a section of the final report to the funders (Autumn 2021) and will form the basis of a planned protocol paper to be drafted in Summer 2020 and submitted for publication.