Study Information

This study investigates ways in which ongoing advances in whole genome pathogen sequencing (strain typing of bugs, like a barcode), bioinformatics and web based database technologies can improve Infection Control (IC) service delivery by looking at 3 important healthcare associated infections (C. difficile, S. aureus and Norovirus). The study will 1) automate the collection and presentation of relevant clinical information, as well as strain typing data, in order to standardise and streamline IC service delivery, 2) provide insight into the relative contribution of in hospital transmission for each bug, and identify where intensive or focussed IC measures could further improve practice 3) identify more accurate methods for linking transmission of strains between “donors” and “recipients” in hospital which could provide new metrics with greater power to identify good and poor practice.

The study design is observational and is taking place at 3 NHS Trusts (Oxford, Leeds and Brighton). All the data and samples are already being collected by clinical teams managing patients with these pathogens, either routinely or in specific outbreak situations. We are not collecting additional samples or data which would not be used for clinical management; there is no contact between the research team and patients; and individual patient management is not affected by the study.

Consent

This study can only directly and accurately address its goals by proceeding without informed consent. This is mainly because in order to recognise and follow outbreaks early enough to intervene effectively at an individual patient level, it is clearly essential that all possible “donors” of a pathogen to a new “recipient” are both captured epidemiologically and have their donating strain sequenced. Otherwise it will not be possible to identify transmission links. Thus failure to provide consent would directly jeopardise the ability to demonstrate that strain typing methods can improve infection control practice and national surveillance.

Confidentiality of data

• All study databases holding epidemiological data (not just the confidential items) will only be stored on NHS servers, subject to NHS security policies (including physical measures (placement of computers within secure areas, physical securing of servers), network security measures (including firewalls), logical measures (including password and/or keycard based two-factor authentication, role based access) etc. 
• All persons developing study databases holding epidemiological data will have either full or honorary NHS contracts. This will also ensure that appropriate disciplinary procedures could be followed in the case of deliberate breach of confidentiality or other misconduct.
• Access to study databases will be based on individual login, with all persons with access to personal data (NHS/hospital numbers and names) required to have either full or honorary NHS contracts.
• Whilst personal and non-personal data will be collected, the use of personal data will be limited as much as possible. Only sex, month of birth, GP practice code, Strategic Health Authority, first three digits of postcode, date of death, NHS/hospital number and names only for the purpose of quantitative evaluation will be used. 

NHS REC and NIGB approval 

The study research protocol version 1.0 for this study was approved by the Berkshire Research Ethics Committee on the 1st October 2010. NIGB approval for ‘support under section 251 of the NHS Act 2006 to process individual patient information without consent’ was approved on the 17th February 2011.  

If participants at any of the 3 NHS Trusts in this study have any queries or would like to dissent from the study, please contact: