LONG TERM HEALTHCARE USAGE OF BARIATRIC/METABOLIC SURGERY COMPARED TO COMMONLY PERFORMED ELECTIVE GENERAL SURGERY PROCEDURES

Despite substantial evidence of efficacy and cost-effectiveness, less than 0.2% of suitable candidates - according to both NICE and international criteria - currently undergo surgical treatment of obesity and/or type 2 diabetes (bariatric/metabolic surgery) in the UK. Widespread misperceptions about the relative risks of bariatric surgery may act as a major barrier to access of this type of treatment. Despite substantial evidence of low overall mortality and morbidity, both lay and scientific media often define bariatric surgery as “high-risk”, or “dangerous” or “last resort”. These misperceptions may deter appropriate surgical candidates from seeking surgery, reduce referral by primary care providers, and mislead health policies decisions and coverage of bariatric/metabolic surgery by NHS commissioners as well as private health insurance.

To date, no study has compared the perioperative safety and mid-term healthcare utilization of bariatric/metabolic surgery with those of other commonly performed elective surgical procedures.

The aim of this study is to compare short- and mid-term safety outcomes and overall healthcare utilization among patients who underwent bariatric surgery and other types of elective surgical interventions for benign diseases at King’s College Hospital (Adrenal, Antireflux, Bariatric, Gallbladder (inpatients & day surgery), Colorectal, Hernia, Neck surgery). The outcome of the study may help demonstrate the safety of bariatric surgery.

This study will ensure that the information is processed lawfully, fairly and in a transparent manner. The study is relying on GDPR Article 6(1)(e) - the research proposed serves the public interest in better understanding the safety and efficacy of bariatric surgery in comparison to other elective general surgeries.

The need to process special category data (data concerning health) is necessary in achieving the study objective. The healthcare usage and the implications of this type of surgery on the health system in comparison to other more established general surgeries will be made clearer by this research. This may ultimately help in formulating more informed decision by policy makers and commissioners and potentially allow Bariatric Surgery more accessible for a greater number of patients who may benefit from the health improvements it offers. The data that will be used in this scientific research will be pseudonymized and stored safely. The principle of data minimisation will also be adhered to and processing of the data will be limited to the scope of the initial purpose outlined in the application and protocols that received ethical approval. (GDPR Art9(2)(j) in accordance with article 89(1)).

This study has received ethical approval from the HRA and Health and Care Research Wales (HCRW).

By analysing the healthcare usage patterns of the different surgical specialties and comparing it to bariatric surgery, a better understanding regarding the safety of each specialty could be reached. To accurately reflect this, a nationwide search needs to be made to capture all admissions and health visits of individual patients.

This is the first study to date that compares the healthcare usage of different general surgery specialties. There are no other relationships between the proposed project under this application and any wider project, collaboration, associated work or follow up.

The study team from King's College Hospital NHS Foundation Trust and King's College London will retrospectively review data from 100 consecutive patients who underwent bariatric surgery by one of the bariatric surgeons at KCH between February 2014 and March 2015 and compare outcomes with those of additional 700 consecutive patients who, between 2006 and 2015, had undergone other types of elective surgeries for benign diseases at the same Hospital (Adrenal, Antireflux, Gallbladder (inpatients & day surgery), Colorectal, Hernia, Neck surgery). The study team plans to look at mid-term rate of re-admissions and related length of stay, emergency department attendances and outpatient hospital encounters over a period of 5-year from the index surgery. Due to restriction is funding, data regarding GP encounters may be sought in the future and due procedures to request this will be followed.

To accurately capture post-operative healthcare usage, data about nationwide healthcare utilization is needed, specifically England. To achieve this, the study team will provide NHS digital with NHS numbers, sex, and date of birth of patients selected to represent the study population to allow the maximum yield possible. The study team will also provide study specific identifiers to be used by NHS digital when the data is sent back to the team without the NHS identifiers to ensure pseudonymization. The data requested will include data on Hospital Episode Statistics (HES) covering accident and emergency, outpatients and admitted patient care. The dataset will cover any use of hospital healthcare facility that patients may have had since their operation and over 5 years postoperatively. The study team believes that 5 years follow up will allow to accurately reflect the impact of each surgery on healthcare usage and re-admission that may be related to the index operation. The operation date for the patients selected ranges from 2006 to 2015. In order to be able to cover the 5-year postoperative follow-up period of all patients in the cohort from the date of the first procedure, the data requested will span from 2006 (first procedure) – 2020 (end of 5-year follow up). The data period cannot be minimised further given the way NHS digital runs queries.

The study team aimed to minimize the data requested as much as possible without affecting the study outcome. For example, data on ethnicity, religious beliefs, social status and other details were not considered as they do not serve the study purpose.

Both King’s College Hospital and King’s College London are the joint Data controller and processor. No other organizations are involved. The funds needed to cover the expenses of data acquisition and analysis are provided by Ethicon, as part of their Investigator Initiated Study funding committee. Ethicon is dedicated to advancing bariatric surgery and the science and treatment of obesity. Ethicon are also involved with the manufacturing and sale of medical devices used in bariatric surgery. However, Ethicon played no role in the study design and will hold no control or property over the study data or outcome. As per the funding contract, their role is limited to providing the funds needed to acquire the data as part of their Investigator Initiated Study funding committee. The Principal investigator holds full control and responsibility over the data received and study outcomes. To not that the Principal investigator carries out bariatric surgeries in his private practice. However, none of the patients included in the cohort had their operations done privately. In addition, the funds that will be used to acquire the data come from Ethicon as previously detailed and any additional amount will be covered from the Principal investigator research funds at King’s College London. No funding for a private source of income or practice will be used. This funding is available until 30/06/2022.

All organisations party to this agreement will 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 study team will provide NHS digital with the patient’s NHS number, date of birth and sex to maximize yield. The study team will also provide NHS digital with study specific identifiers that will be used by NHS digital once the data is sent back. The pseudonymized Dataset which will include patients’ health data and healthcare usage will then be sent by NHS digital to the principal investigator (PI), a substantive employee from King's College Hospital NHS Foundation Trust, using Secure Electronic File Transfer (SEFT). Once this is completed, no future data flow is expected. The data sent to the study team will include HES on accident and emergency, outpatients and admitted patient care covering the period between 2006 and 2020. This will allow the study team to capture 5 years of follow up on the cohort. Any patient data extending beyond the 5 years mark from the index operation will not be processed and will be destroyed to NHS Digital's standards. The file linking the NHS number and the study identifiers will be kept under secure lock in a separate file in the PI's office.

Once the dataset is received, the study team will ensure it is stored in a secure storage location in the PI’s office under lock. Access to the Principal investigator office area is restricted by two doors that are accessible only by magnetic security cards. The office itself is secured by a key lock. The data will be stored on the Principal investigator NHS computer which is password protected.

The data will be reviewed by the study team. The Data on each patient will be limited to 5 years follow up and tabulated using the study's ID. Once finalized, the data on all three sets (accident and emergency, outpatient and admitted patient care) will be sent to an experienced statistician for the statistical analysis. The statistician will be a staff of King’s College London (which is both a data processor and controller). The results are reviewed by the study team and finalized before the manuscript is drafted.

Once completed, the manuscript will be submitted to a peer-reviewed journal for publication. The data will be kept for 6 months after publication before being safely destroyed.

The Data will not be linked or matched to publicly available data. There will be no attempt to re-identify individuals.

Data processing will be carried out by employees of KCL and KCH who have been appropriately trained in data protection and confidentiality.

The Data will be stored in the PI’s secured office at premise which is owned by KCL. Access to the office is regulated by magnetic card with security 24/7. The data will be kept on a password-controlled NHS computer. The file containing the data will be password protected once received. To confirm, access to the Principal investigator office area is restricted by two doors that are accessible only by magnetic security cards. The office itself is secured by a key lock. The data will be stored on the Principal investigator NHS computer which is password protected.

The main outcome of the study is to assess the overall medium-term healthcare usage of bariatric/metabolic surgery and to compare the healthcare usage of bariatric surgery to other commonly performed elective general surgery procedures. The study also aims to assess the cost of overall healthcare usage of bariatric surgery on a national health system. A longer-term study may be of use in the future to follow- up on the findings of this study, to possibly validate or re-evaluate the conclusions made.

The study manuscript will be submitted to peer reviewed journal for publications. Based on previous experience and communications, it is expected that journals such as Lancet, BMJ, NEJM, SOARD and Obesity surgery would be interested in nationwide studies that look into safety profile, cost to healthcare and surgical outcomes of different surgical specialties, especially bariatric. Study results will also be presented in national and international conferences. Conferences may include but not restricted to BOMSS, IFSO and ASMBS annual meeting. The study team expects that the findings of the study will support that Bariatric surgery does not lead to increased healthcare usage. In fact, it is expected that bariatric surgery will have significantly less healthcare usage than most specialties. The study team hopes that these results may help guide commissioners and authorities when developing policies, guidelines, and funding for bariatric surgery. The study team will aim at communicating these results to the relevant authorities once available. No specific meeting has been scheduled for now, however the PI is routinely involved in meetings and communications about management of Obesity and Diabetes with the relevant authorities, and the study team expects that this will play an important part in disseminating the study results. The study team will also publish the study results on the King’s website in addition to press communications and releases to make it available for the public and increase awareness.

To influence policy makers and commissioners in making bariatric surgery more accessible and available to patients, the study team will present the results to the necessary authorities. The PI is routinely involved in meetings and hearings that discuss the management of Obesity and Diabetes. This will offer access to the relevant authorities and may help in making sure the study outcomes reach the policy makers and results in the change desired. Media interviews and news articles discussing the results will also be sought after to increase awareness about the safety of bariatric surgery which is believed to be the main outcome of the study. The study team expects these results to be available within 6 months of receiving the data from NHS digital.

No direct patient or public involvement took place during the design of the study or selection of the cohort. Nevertheless, as part of the confidentiality advisory group (CAG) application and approval, the study team surveyed the public opinion about the benefit of the study. This was initially planned to be in the form of surveys that would be filled in clinics. However, due to the restrictions imposed by Covid-19, CAG agreed that the study team could use a support group on social media (Nu You) to survey public opinion regarding the study design and goals. This group is private and includes around 500 members of patient who had bariatric surgery along with patients who are awaiting or considering surgery. The overall response was supportive and expressed interest in the knowing the study’s outcome once available.

This study will not result in the development of tools and new technologies.

The outcome will not include any identifiable data, nor will it include study specific identifiers. All outputs will be aggregated with small numbers suppressed in line with the HES analysis guide.

The data and the study results will be to sole property of the named data controllers. Funders will have no access to the data from NHS Digital. The data will be managed by the study team and kept under safe storage until the end of the study period, and then destroyed providing NHS Digital with a data destruction certificate. The knowledge and outcomes resulting for the processing of this data will be managed by the principal investigator and presented to appropriate peer reviewed journals.

Only substantive employees of King's College London and King's College Hospital NHS Foundation Trust will have access to the record level data.

The study team aims at having the study manuscript ready within 6 months of receiving the data. The study team initially did not anticipate any need for extension or renewal. However, an extension is being requested as he data was received in September 2021 after a delay.

The study does not have any EU funding.

The study aims to increase awareness about the potential safety of bariatric surgery by comparing it to other commonly performed elective general surgery procedures. These outcomes may potentially influence policy makers and commissioners' decision making when considering funding for bariatric surgery. This may make bariatric surgery more accessible to patients who could significantly benefit from the positive impact bariatric surgery and weight loss have on multiple medical conditions. Today, less than 0.2% of suitable candidates - according to the National Institute for Health and Care Excellence (NICE) and the international criteria - currently undergo surgical treatment of obesity and/or type 2 diabetes (bariatric/metabolic surgery) in the UK.

The study results will also be disseminated publicly and aim to increase awareness on the safety of bariatric surgery which may encourage patients to discuss it or request access/referral from their GPs Results will be posted on King's College Hospital website. The study team will aim to communicate the findings from the study via press releases to media and news channels such as the BBC and via articles in the newspaper such as the Times, the Guardian.

If study outcomes manage to influence policy makers and commissioners, the benefit will primarily affect patients suffering from obesity and diabetes, which currently affects 29% of adults in the UK. The benefits may have a nationwide effect given the potential impact a change in policy can have on the healthcare cost that is incurred in medically managing these two conditions. A cost that may be significantly reduced by making bariatric surgery more available to suitable candidates.

The data was received in September 2021 after a significant delay caused mainly by the COVID-19 pandemic. The data is currently being organised and the codes are being translated into clinical terms in preparation for statistical analysis.

The initial impression from the data is the Bariatric surgery is indeed safer than most other elective general surgery procedures. However, this needs to be further confirmed following statistical analysis.

No report or publication has yet been drafted or issued from the data received.