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Article History

Received: 27 September 2020

Accepted: 30 August 2021

First Online: 15 November 2021

Declarations

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: This was not a research study; it was service redesign/evaluation and thus did not require research ethics approval. Both audit and service evaluation are considered part of usual professional practice in the NHS, they are exempt from a review by a research ethics committee (REC) as any ethical concerns should be identified as inherent in clinical or professional ethics. This is set out in the document. “Decision Tools: Defining Research Table () by the Health Research Authority. According to the document UK Policy Framework for Health and Social Care Research definition of research:“3.1 For the purpose of this policy framework, research is defined as the attempt to derive generalisable or transferable new knowledge to answer or refine relevant questions with scientifically sound methods. This excludes audits of practice and service evaluations. It includes activities that are carried out in preparation for or as a consequence of the interventional part4 of the research, such as screening potential participants for eligibility, obtaining participants’ consent and publishing results. It also includes noninterventional health and social care research (i.e. projects that do not involve any change in standard treatment, care or other services), projects that aim to generate hypotheses, methodological research and descriptive research. Projects whose primary purpose is educational to the researcher, either in obtaining an educational qualification or in otherwise acquiring research skills, but which also fall into the definition of research, are in scope of this policy framework. Activities that are not research according to this definition should not be presented as research and need not be conducted or managed in accordance with this framework. A decision tool that provides a definitive answer about whether a project counts as research under this policy framework is available at The NHS guidance for seeking ethics approval as set out in: states that Post Market Surveillance (PMS) studies may be classified as service evaluation, where all the following criteria are met: Since the current study can be classified as a Post Market Surveillance Study of a product that was used unmodified for service evaluation or service redesign no ethics approval was required. The document “Governance Arrangements for Research Ethics Committees: 2018 Edition (GAfREC 2018)” by NHS and “Standard Operating Procedures for Research Ethics Committees version 7.3 (September 2018) by NHS Health Research Authority provide guidance on the area. Additionally, there were no participants lacking in cognitive decline to such an extent that they could not give informed consent to participate/publication.

: This service redesign programme was undertaken as usual service, and thus did not require specific patient consent over and above implied patient consent for usual delivery of primary care. Also, there are no identifying images or other personal or clinical details of participants in this study to declare that compromise their anonymity. Thus, this was not applicable to the current research.

: GB is a research student at Staffordshire University; RC is employed by Stoke-on-Trent Clinical Commissioning Group; PB has no declarations of interest.