Spectral Profiles of Effusions with Confirmed Test Results and Arthropathy Library – (SPECTRAL)

Background:

Joint arthropathies are a significant problem for patients, clinicians, and a health economic perspective. Patients diagnosed with various joint diseases are subject to a litany of tests or procedures based off complex clinical presentations. Suboptimal management of joint arthropathies has been associated with lost productivity, loss of quality of life (QoL) and major surgery. The impact of over-diagnosis, under-diagnosis, unnecessary treatment, or delayed treatment are well established in current literature, hence the drive to improve accuracy and time to definitive diagnosis for patients with joint arthropathies.

Given the ongoing demand to improve quality and consistency of care we propose to create a spectral library of various joint arthropathies based off current gold standard tests. The library ideally will allow us to create signature profiles of conditions that in future can be used as a diagnostic adjunct for undiagnosed patients. From a quality and safety perspective, SPECTRAL aims to address the widespread problem of variation in clinical care via the creation of a novel testing modality that will hopefully be immune to current confounders that complicate modern diagnostic methods. A spectral library of signatures from patients with confirmed joint arthropathies is therefore vital to the creation of a modern diagnostic solution.

The Northern Hospital Orthopaedic Surgery, Rheumatology, and Microbiology departments have recognised the need to improve accuracy and time to diagnosis for patients with joint arthropathies. Through consultation they have agreed to participate in the creation of a library of spectral signatures for patients under their care who have confirmed diagnosis of specific joint pathologies. These pathologies include, septic arthritis, Rheumatoid Arthritis, Gout, Pseudo Gout, Prosthetic Joint Infections, and a host of less common diagnoses.

The primary aim of SPECTRAL is to facilitate the use of data for research, to improve knowledge of diseases and to advance treatment. In its current format SPECTRAL will only consist of patients presenting through the Northern Health network (The Northern Hospital and Broadmeadows Hospital), Melbourne, VIC.

Biobanks and Data Libraries

From the NHMRC Biobanks Information Paper;

“Biobanks are generally large collections of human biological materials (biospecimens) linked to relevant personal and health information (which may include health records, family history, lifestyle and genetic information) and held specifically for use in health and medical research. Their object is to provide a resource for researchers to use to advance our understanding of human health and disease.” (102)

A proven strategy to improve the accuracy, consistency, and time to diagnosis of various conditions has been through the use of a Biobank. Biobanks have allowed the meticulous review of human tissue samples for research purposes including the creation of diagnostic criteria. Historically, this took the form of tumour tissue samples and the creation of histological grading or scoring systems such as the Gleason score for prostate cancer (100). Through iterations of refinement and review these histological scoring systems have become the gold standard for diagnosis and prognosis of many cancers. Necessarily, libraries of example histological slides have been created to standardise the classification of tissue samples. No such biobank or library currently exists for the Spectral signatures of joint fluids and joint related pathologies. From a research perspective, biobanks have for decades provided epidemiological and tissue sample information regarding characteristics of disease and patterns of care and are increasingly used to advance pharmacogenomics and personalised medicine (101).

The fundamental purpose of a biobank, and thus SPECTRAL, is to improve the quality of care we provide to patients. SPECTRAL will allow us to collate previously unrecorded information, cross reference with linked conditions, and potentially track the impact of treatment on various joint arthropathies.

Aims and Objectives

The primary aim of SPECTRAL is to create a database library of spectral signatures that may distinguish various joint arthropathies from one another.

Thus, the aim can be further subdivided to highlight the initial goal and subsequent goal.

1. Create a library of spectral signatures that may assist in the diagnosis of specific joint arthropathies as define by gold standard testing.
2. Build a database of spectral signatures that can become representative for specific joint arthropathies and thus be distinguishable from one another for diagnostic purposes.

Outcomes and Significance

Establishment of a spectral library of joint effusions from joint arthropathies offers the potential to make considerable inroads into our ability to diagnose and thus treat patients in a timely fashion. However, if successful it is entirely feasible that SPECTRAL will generate considerable advances in our understanding of various joint pathologies.

Potential future areas of research or significance:

• Identify unique spectral signatures for specific joint conditions.
• Allow for identification of multiple concurrent conditions within a single sample.
• Identify subsets of conditions that were previously unknown.
• Determine the efficacy of treatments through change in spectral signatures.
• Isolate causative pathogens or their sensitivities and resistances in infective arthropathies.

The implications and potential benefits of a library of spectral signatures for joint pathologies is considerable, and it is entirely possible that there are even more potential research options or clinical benefits we are yet to identify.

Consent and sample acquisition

While the Biobanks information Paper (NHMRC, 2010) stipulates that a waiver of consent may be relevant in instances where a biobank is being created from samples already obtained for clinical reasons, we think it prudent to obtain consent for several reasons:

• Clarity to patients and organisations on the intended use of specimens
• Ability to withstand local, national, or international scrutiny in regard to the acquisition of samples.
• Allow patients, families, guardians, medical treatment decision makers, to be adequately informed as to how the sample may provide benefit to them, their family, or the community.
• To foster interest and understanding regarding SPECTRAL and our purpose.
• Allow for the potential acquisition of samples that would otherwise not be available.

Opt-out and data retention

Participants may opt-out of SPECTRAL at any time after their inclusion. While this is not anticipated given that there is unlikely to be any burden upon patients or subsequent contact to prompt desire to withdraw; we feel it necessary to ensure that patients can escalate concerns and withdraw from inclusion at any stage. We will allow for two types of patient opt-outs; a partial opt-out and a complete opt-out.

1. Partial opt-out: Patients will have their personal information removed from our records, but their spectral signature information and relevant diagnostic information will be retained.
2. Complete opt-out: All information obtained from the patient including their diagnosis will be removed, their sample if any remaining will be destroyed. However, as the spectral signature we create is not unique to the patient, identifiable, or owned by the patient, we feel that it is within our scope of establishment of a biobank library to keep this information.

Australian Federal, State and Territory Personal Information and Privacy Legislation

The SPECTRAL activities in Australia are governed by the laws and ethical requirements of each relevant jurisdiction, and there are several Federal, State and Territory Acts that are relevant to the collection, storage and use of personal information. The key pieces of legislation and guidance/guidelines in each State and Territory are listed below in Table 2. Currently SPECTRAL intends only to operate within, and thus be guided by, Victorian Legislation and Federal legislation.

Table 2: Legislation and Guidelines governing health and personal information in Australia

Jurisdiction	Legislation
Queensland	Information Privacy Act 2009 Public Health Act 2005 Hospital and Health Boards Act 2011 Hospital and Health Boards Regulation 2012
New South Wales	Statutory Guidelines on Research. Information and Privacy Commission NSW. Health records and information Privacy Act 2002 Privacy and Personal Information Protection Act 1998 Statutory Guidelines on Research. Section 27B.
Western Australia	No Specific Privacy or Records Legislation
Tasmania	Personal Information Protection Act 2004
ACT	The Information Privacy Act 2014
Northern Territory	Information Act 2002
South Australia	No Specific Privacy or Health Records Legislation Health Care Act 2008
Victoria	Privacy and Data Protection Act 2014 Health Records Act 2001 Statutory Guidelines on Research issued for the purposes of Health Privacy Principles 1.1(e)(iii) & 2.2(g)(iii)

Federal

For Commonwealth held data (this includes Medicare MBS and PBS items), the Privacy Act 1988 (Privacy Act)(19) covers usage and is underpinned by 11 Australian Privacy Principles (APPs). In December 2000, the Privacy Amendment (Private Sector) Act 2000, which commenced on 21 December 2001, extended coverage of the Privacy Act to some private sector organisations. The Privacy Act also covers My Health Record information under the My Health Records Act 2012 and individual healthcare identifiers under the Healthcare Identifiers Act 2010.

The Office of the Australian Information Commissioner (OAIC) has issued a guideline to the APPs which sets out expectations for organisations. In section 3.22 it outlines that APP3.3 requires organisations to obtain consent from individuals for collection of sensitive information. The guidelines define ‘consent’ in Section 6(1) as ‘express consent or implied consent’. The four key elements of consent defined in Chapter B under B35 are:

• The individual is adequately informed before giving consent
• The individual gives consent voluntarily
• The consent is current and specific
• The individual has the capacity to understand and communicate their consent

The Chapter goes on to further define what express and implied consent are;

B.36 Express consent is given explicitly, either orally or in writing. This could include a handwritten signature, an oral statement, or use of an electronic medium or voice signature to signify agreement.

B.37 Implied consent arises where consent may reasonably be inferred in the circumstances from the conduct of the individual and the APP entity.

These are important as it clearly permits electronic or telephonic means to communicate with participants and obtain their consent, that is, eConsent or Tele Consent.

The Federal Privacy Guidelines provide a commentary on assumptions regarding consent where the intention is not to obtain express or implied consent, that is, through ‘opt-out’ mechanisms. Specifically;

B.39 Generally, it should not be assumed that an individual has given consent on the basis alone that they did not object to a proposal to handle personal information in a particular way. An APP entity cannot infer consent simply because it provided an individual with notice of a proposed collection, use or disclosure of personal information. It will be difficult for an entity to establish that an individual’s silence can be taken as consent. Consent may not be implied if an individual’s intent is ambiguous or there is reasonable doubt about the individual’s intention.

and,

B.40 Use of an opt-out mechanism to infer an individual’s consent will only be appropriate in limited circumstances, as the individual’s intention in failing to opt-out may be ambiguous. An APP entity will be in a better position to establish the individual’s implied consent the more that the following factors, where relevant, are met:

• The opt-out option was clearly and prominently presented
• It is likely that the individual received and read the information about the proposed collection, use or disclosure, and the option to opt-out
• The individual was given information on the implications of not opting-out
• The opt-out option was freely available and not bundled with other purposes
• It was easy for the individual to exercise the option to opt-out, for example, there was little or no financial cost or effort required by the individual
• The consequences of failing to opt-out are not serious
• An individual who opts-out at a later time will, as far as practicable, be placed in the position as if they had opted out earlier

The SPECTRAL is subject to the Federal Privacy Act when collecting data from Private or Commonwealth agencies.

Victoria

In a 2019 publication called “Key Concepts” issued by the Office of the Victorian Information Commissioner (OVIC)(20), opt-out consent models are described as being less preferable than opt-in because “Opt-out models create uncertainty as to whether consent is validly given. Simple failure to tick a box, as in the example above, may be due to the individual not reading that section of the form rather than the person actively consenting to what is proposed.” This position of the OVIC is related to the Privacy and Data Protection Act 2014 (PDP) and was issued in 2019. Schedule 1 of the PDP contains the Information Privacy Principles (IPPs) and IPP2- Use and Disclosure does permit disclosure by an organisation under 2.1 for reasons that align with the function of a CQR. Further, under the Health Records Act 2001 collection or disclosure of health information without consent would be a breach unless a HREC had granted a waiver of the requirement for consent. The Statutory Guidelines on Research issued for the purposes of Health Privacy Principles 1.1(e)(iii) & 2.2(g)(iii) provides specific guidance on how this should be dealt with. In brief, the provisions are substantially similar to those of the Federal Privacy Act legislation⁽²¹⁾. To avoid confusion and for other reasons as outlined in section 3.2.2 we will utilise an “opt-in” process whereby a consent form and informed consent are utilised. In the event that SPECTRAL proves to be a useful tool for the improvement of quality of care for patients and a recommendation is made to adopt a “registry” model of “opt-out” consent (ala The Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR), and the Prostate Cancer Outcomes Registry – Australia and New Zealand (PCOR – ANZ) then this will be submitted as an addendum to the necessary HREC.

SPECTRAL Documents

• SPECTRAL OPERATING FRAMEWORK and STATEMENT OF COMPLIANCE (101345)
• SPECTRAL PATIENT INFORMATION PAMPHLET (101345)