NHS Digital Data Release Register - reformatted

University of Aberdeen

Opt outs honoured: N

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

Format: Anonymised - ICO code compliant Non Sensitive

How often: One-Off

When: unknown — 11/2016

HSCIC Id: DARS-NIC-394629-C5Z4P-v0.2

Data: Hospital Episode Statistics Outpatients

Data: Hospital Episode Statistics Admitted Patient Care

Data: MRIS - Cause of Death Report

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Cause of Death Report

Data: MRIS - List Cleaning Report

Data: MRIS - Cohort Event Notification Report

Data: MRIS - Scottish NHS / Registration

Data: MRIS - Cause of Death Report

Data: MRIS - Scottish NHS / Registration

Data: MRIS - Cohort Event Notification Report

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

Outputs will contain only aggregate level data with small numbers suppressed in line with the HES analysis guide.

Activities: The personal identifiers of the consented participants (cohort) will be supplied be the University of Aberdeen to the HSCIC. This will include: NHS Number, Date of Birth, Sex, Postcode and a unique participant ID. The HSCIC will supply linked HES data containing no identifiers other than the unique participant ID which will be used by the study team to re-identify the data and link it to other data collected by the study - specifically:

i) Patient reported outcomes collected via questionnaires which are distributed by the study team to participants at 1, 3, 6 weeks, 12, 24 and 60 months.

ii) Clinical data collected at the individual hospital centres using, where necessary, hospital based records and hardcopy CRF forms at the time of surgery and at 6-week clinical follow-up. These clinical data are then input into the eTHoS database by local researchers using an electronic web-based data capture system. Extensive range and consistency checks enhance the quality of the data. Staff in the Study Office will provide periodic data queries to local research staff to ensure that the data are as complete and accurate as possible.

The additional relevant clinical data collected from routine data sources (HES & ISD) provide re-admission information related to haemorrhoids to evaluate long-term safety and the need for further haemorrhoid treatment to fulfil secondary clinical and economic outcomes and complete the overall objective of the trial. The data HSCIC provides will be used to compare effectiveness between the two surgical procedures and will not be used for any other purpose.

Data will only be processed and stored at the stated location, and no record level data with be shared with any third parties.

Objective: Haemorrhoids are a common problem and can be painful. The symptoms can be relieved by removing the haemorrhoids in an operation. There are two ways in which surgeons can remove haemorrhoids but not enough is known about how the methods compare. Currently, surgical treatment for haemorrhoids depends on the surgeon’s preference.

The eTHoS trial is a pragmatic multicentre randomized controlled trial. The objective is to compare the two kinds of operations in order to inform surgeons about which operation is best for patients (in terms of patient quality of life, health economic and clinical outcomes). In order to achieve this objective, several areas of patient care and status will need to be considered.

To enable accurate and reliable analysis, patient reported health status will be collected over the trial period from patient questionnaires as well as information on symptoms related to haemorrhoids, general health and complications from either procedure collected on clinical forms. Cost between surgeries will also be evaluated and in order to fully compare the overall clinical and economic costs, readmission data from Hospital Episode Statistics (HES) and Information Services Division (ISD) Scotland is required to quantify long-term safety and haemorrhoid reoccurrence. This in turn will be used to assess the full impact of on patients’ quality of life and enable an assessment of the overall costs to the NHS if, for example, one of the surgeries resulted in higher reoccurrences and further interventions to remove haemorrhoids.

The results report which will be published on the HTA (Health Technology Assessment Programme, of the National Institute for Health Research) website which will be publically accessible and will inform patients, surgeons and other health care professionals about the clinical and cost effectiveness of the two major surgical haemorrhoid interventions being investigated and provide appropriate information to help NHS Trusts to base decisions on which treatments to offer.

Benefits: Haemorrhoids are common in all age groups from mid-teens onwards. The currently available data comparing the clinical and cost-effectiveness of stapled haemorrhoidopexy and conventional excisional haemorrhoidectomy are poor.

The results of the eTHoS trial will be available in late 2016/early 2017. The expected benefits to the NHS will be that the trial will provide robust information about which of the two surgical procedures for haemorrhoids is the most clinically successful and cost effective again by comparing variables such as haemorrhoid reoccurrence and further surgeries in both surgical procedure arms. This information will enable cost savings to the NHS and will directly benefit patients. The trial will provide information about the quality of life for the patients who have had the surgical procedures, including pain, recurrence, time to recovery, faecal urgency, and adverse effects of treatment. This information can be used to select the appropriate type of procedure for optimal outcomes and patient experience. The patient experience is a core objective of the trial.

The Department of Health has requested this study and will use its results to determine the optimum approach to treating patients in order to improve patient care. The HTA monograph is the report to funder (Department of Health), under the auspice of the Health Technology Assessment Programme (HTA). The HTA will disseminate the full report on their website for the information of all health care professionals for example surgeons, GPs and healthcare policy makers. Patients and the general public will also be able to have full access to the findings of the trial.

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

Source: NHS Digital.