ACU-Track Publication Guidelines V1.1

These guidelines pertain to anyone planning on publishing data collected via the ACU-Track registry; hosted by Amplitude Clinical. This includes:

• Practitioner and clinic subscribers wishing to publish their own clinical data.

• Trusted Registry Partners (TRPs) who have been granted access to anonymous registry data specifically for research or auditing purposes.

As per our Terms of Use, all published studies using data collected via ACU-Track must be done in accordance with these guidelines.

What is a Clinical Audit?

“Clinical audit is a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change. Aspects of the structure, processes, and outcomes of care are selected and systematically evaluated against explicit criteria. Where indicated, changes are implemented at an individual, team, or service level and further monitoring is used to confirm improvement in healthcare delivery.”

• From: National Institute for Clinical Excellence NICE. Principles for Best Practice in Clinical Audit.

All data collected via the registry is considered to be “part of routine clinical practice”. This means that we do not ask or request patients or practitioners to provide/collect any additional information that they would not ordinarily do within their role as healthcare professionals. This typically categorises the data collected (and the subsequent analysis of this data) as within the remit of a “clinical audit” or “service evaluation” rather than “research”.

The majority of analyses and publications produced using data from the ACU-Track registry will therefore typically take the form of “clinical audits”, “observational” or “cohort” studies as there is no control group or experimental group. These types of studies are not able to definitively prove causation, only establish correlation, Any interpretation of results should there be carefully framed and any conclusions drawn be cautious. For example:

“Overall, patients who attended our clinic over the last year reported clinically meaningful improvements in their pain levels in the short-to-medium term.”

Does a Clinical Audit require Ethics Approval?

“Clinical audit by definition does not involve anything being done to patients other than their normal clinical management. Therefore it does not usually require formal ethical approval unlike research. This does however mean that it is essential that projects undertaken in the name of clinical audit are not in fact research. All clinical audits must be conducted within an ethical framework. In practice this means that consideration should be given to such issues as confidentiality and disclosure of audit results.”

• From: Hughes M. Clinical Audit: A Manual for Lay Members of the Clinical Audit Team.

Clinical audits, like case studies/series, are typically exempt from requiring ethics approval in the UK. However, this may not necessarily be the case in all countries and we urge individual practitioners and clinics to perform their own due diligence on whether or not any analysis of their own patient data represents a true clinical audit or may in fact be considered research; if the later is the case then the practitioner/clinic should seek to gain Independent Ethics Approval by a recognised Independent Ethics Committee prior to conducting/publishing an analysis of their clinical data.

Other useful references:

• Ivers N, Jamtvedt G, Flottorp S, et al. Audit and feedback: effects on professional practice and healthcare outcomes. Cochrane Database Syst Rev 2012; CD000259.

• White A. Conducting and reporting case series and audits--author guidelines for acupuncture in medicine. Acupunct Med J Br Med Acupunct Soc 2005; 23: 181–187.

When might a Clinical Audit be Research?

Research typically looks to answer specific questions such as looking at comparative effectiveness between different types of treatments/interventions. Data collected via the registry could be used to help answer specific research questions. For example:

• Does acupuncture or Chinese herbal medicine provide better outcomes for X health condition?

• Are there more adverse events associated with acupuncture compared to moxibustion or cupping therapy?

If you are utilising registry data to perform an analysis along these or similar lines, this may be considered research as opposed to an audit. In such cases, you will need to acquire ethics approval by a recognised Independent Ethics Committee prior to commencing any data analysis. If you are unsure as to whether your analysis/proposed publication may constitute research, then we always recommend you check with a recognised ethics committee/IRB.

Referencing the ACU-Track Registry

The ‘ACU-Track Registry, hosted by Amplitude Clinical’, must be acknowledged as the source of the data whenever any data collected via the registry is used in any publication or press release (including electronic versions). This includes any academic publications, articles and/or website references. The registry reference must include a hyperlink to the ACU-Track website: https://www.acu-track.org/

Website Publication and Advertising

Data collected via the registry may be used for advertising and/or marketing purposes by practitioner/clinic users. However, this should be done cautiously in accordance with the following:

• Any relevant national or international advertising standards or legal guidelines.

• Any analysis/presentation of data, as well as the discussion and interpretation of results, should strictly adhere to rigorous academic standards.

• Reference what type of evidence registry data is (pragmatic, observational) within the context or other types of evidence (e.g. randomised control trials, systematic reviews).

Academic Publication

Any publication using registry data should:

• Meet approval from a recognised Independent Ethics Committee if the publication is considered to be research.

• Adhere to rigorous academic standards in regards to the analysis of data, as well as the discussion and interpretation of results.

• Be published Open Source wherever reasonably possible so that the paper is free for everyone and anyone to read.

• Be communicated directly to ACU-Track to be listed as a registry published paper on the ACU-Track website: https://www.acu-track.org/ - please contact us when you have published your data and we will ensure a link is uploaded on our website: enquiries@acu-track.org

Patient Consent 

Any publication of registry data must only be done with the consent of each patient. TRPs may only have access to anonymous clinical data for which the patient has given their express permission that their data may be used for research/auditing purposes. For practitioner/clinic users, it is their responsibility to ensure that only patients who have given their express consent for their anonymous data to be processed for research/auditing purposes are included in any analysis and/or publication. Guidelines are given to users on how to filter out and delete any non-consenting patients prior to publication/sharing.

Breach of Guidelines

Any publications of registry data found not to be in adherence of these guidelines will be considered a breach of our ‘Terms of Use’. In such instances ACU-Track will request that the publication be amended to comply with these guidelines. ACU-Track retains the right to terminate any subscription or registry partnership in the event any terms have be found to be breached.