Health Technology Review

Troponin | Point of Care Testing in Rural and Remote Community Health Centres

What Is the Issue?

• Acute coronary syndrome (ACS), including myocardial infarction (MI), is a leading cause of morbidity and mortality worldwide and survival rates for MI may be lower in rural and remote settings compared to urban settings.

• While chest pain is a common symptom of ACS, most patients with this symptom will ultimately not be diagnosed with MI and diagnosis can be challenging. Recommendations for diagnosis include many factors, one of which is serial blood sampling to test for cardiac troponin (cTn), a biomarker for cardiac injury. High sensitivity, laboratory-based assays are typically recommended for cTn testing ideally within 60 minutes of a patient’s presentation.

• In many rural and remote community health centres, including in Canada, laboratory services are not easily accessible, and results may not be available for hours or days. The current clinical practice in many of these regions is to transfer patients presenting with suspected ACS to the nearest hospital or tertiary care centre, sometimes over long distances and by aeromedical transfer, and often at a high cost. Given many of these patients will not ultimately be diagnosed with MI or require hospital-based care, this poses a concern for patients, staff, and resources.

• Point-of-care tests (POCT) for cTn may offer an interesting opportunity in these settings. Efficient access to cTn results may potentially improve the ability for health care workers in community settings to more easily diagnose and triage patients at risk for MI and potentially avoid unnecessary patient transfers. However, cTn POCTs are generally less sensitive than laboratory-based assays with varied performance between devices and staff training is required for implementation and quality control. It is important to understand the clinical utility and recommendations regarding the use of cTn POCTs in remote and rural settings.

What Did We Do?

• This rapid review has been conducted in response to a request from a jurisdictional service provider to help determine if implementation of POCTs for a cardiac biomarker, cardiac troponin I (cTnI), should be considered in rural and remote community health or primary care centres. The research questions were codeveloped in response to this request. We aimed to identify and summarize recent evidence on the current use, clinical utility, and guideline recommendations regarding cTnI POCTs to support patient diagnosis and triage in these settings, where access to laboratory-based cTn results may be limited.

• We searched key resources including journal citation databases and conducted a focused internet search for relevant evidence published since January 2009. No critical appraisal of identified information was conducted.

What Did We Find?

• We identified 2 point-of-care testing programs implemented in rural jurisdictions that include cTnI POCTs, 1 in Australia and 1 in New Zealand; no records met our eligibility criteria regarding cTnI POCT use in rural and remote settings in Canada. The included reports describe program-related processes and experiences, including approaches to structured governance and oversight, training, and quality control. We also identified 2 surveys of general practitioners’ (GPs) current and desired use of cTnI POCT, 1 from Germany and 1 from South Africa, with limited applicability to the setting in Canada.

• We identified 2 health technology assessments (HTAs (with 3 eligible studies in 4 reports) and 2 primary observational studies examining the clinical utility of cTnI POCT in community health centres in rural and remote settings. One HTA, including 2 studies, and 1 primary observational study assessed cTnI POCT as part of an accelerated diagnostic protocol (ADP), a clinical decision algorithm, incorporating cTnI POCT results with electrocardiogram (ECG) results, clinical assessment, and patient history. The results suggest that cTnI POCTs, when used within the context of an ACS-ADP, have the potential to identify low-risk patients (high sensitivity and negative predictive value), and reduce unnecessary referrals or transfers when there is limited or no efficient access to laboratory-based results.

• While the included HTAs appear to be well conducted, they identified few primary research studies, studies were focused primarily on 1 cTnI POCT used within specific ADPs, the studies lacked a control group, and no studies assessed high-sensitivity cTnI POCTs. The results cannot be translated to other cTnI POCT devices nor those used within other ADPs. We identified no studies conducted in rural or remote jurisdictions in Canada.

• While some existing guidelines provide specific recommendations on components of our questions, we did not identify evidence-based guideline recommendations on the use of cTnI POCT in rural or remote community health centres.

What Does It Mean?

• The studies we identified suggest that cTnI POCTs may be useful in rural and remote community care settings to help identify patients presenting with symptoms of ACS who may be at low risk for MI, potentially avoiding unnecessary patient transfers to hospital.

• As the clinical utility of cTnI POCTs is dependent on the device used, patient-management protocols and contextual factors such as underlying community risk, social acceptability and resources — and we identified no studies conducted in rural and remote community care settings in Canada — the applicability of the results is unclear. To better understand their use, cTnl POCTs should be assessed within a suspected ACS-ADP in the context of interest to better understand their utility.

• The experiences published about rural or remote community POCT programs outside of Canada highlight various factors that may inform decision-making in Canada including the importance of governance and oversight structures; continuing resources for training, accreditation and quality control; and the challenges with high staff turnover in rural and remote regions.

• As high-sensitivity cTn POCTs become available, it will be important to assess their clinical utility in settings of interest.

Context and Policy Issues

Acute Coronary Syndrome

In Canada, approximately 2.6 million people live with heart disease¹ and it is the second leading cause of death.² ACS refers to multiple forms of coronary artery disease where blood flow to the heart is suddenly reduced and includes acute MI, heart attack, and unstable angina. ACS is one of the leading causes of morbidity and mortality worldwide; more than 63,000 adults in Canada are diagnosed with their first heart attack annually³ and approximately 2% of patients have had a previous heart attack. In rural and remote settings, the risk of death due to MI may be higher than in urban settings.⁴

Diagnosis of Acute Coronary Syndrome

Prompt recognition and treatment of ACS is critical. Patients experiencing ACS often present with chest pain and this is one of the top reasons for emergency department (ED) visits in Canada,⁵ yet only a small proportion of patients presenting with chest pain will ultimately be diagnosed with ASC.⁶ Symptoms of ACS can vary by sex and other factors, and chest pain is neither a necessary nor a specific symptom for diagnosis.^6,7 Diagnosis and triage of ACS includes multiple assessments, one of which is serial blood sampling to test and monitor levels of a cardiac injury biomarker, cTn — specifically cTnI or cardiac troponin T (cTnT). Other factors (e.g., injury) can also elevate or change cTn levels, thus triage and prompt diagnosis of ACS also includes relevant patient history, physical examination, and an ECG within 10 minutes of presentation. Patients with suspected ST-elevated MI (based on ECG results) require emergent intervention irrespective of cTn levels. For patients with suspected non–ST-segment elevation MI (NSTEMI), cTn testing is recommended as a component of a suspected ACS-ADP (i.e., a rapid MI rule in-rule out strategy).^7-9

High-sensitivity laboratory assays are generally recommended for cTn measurement, with results recommended within 60 minutes of initial presentation.^7-9 However, regular and efficient access to laboratory services is not available for many community care centres in rural and remote settings, where more than one-third of the population in many of Canada’s provinces and territories reside.¹⁰ Wait times for results can range from hours to days, inhibiting the ability to efficiently diagnose and triage patients onsite. These centres also do not typically have cardiologists or other specialist services. As such, reported standard practice is to transfer patients with suspected ACS to the nearest hospital or tertiary care centre for assessments including repeated laboratory-based cTn measurements. Transportation can include long-distance travel, in some cases by air ambulance or helicopter. In the northern territories in Canada, for example, much of the population lives greater than 100 km from, and often without road access to, the nearest hospital; thus, there is a high reliance on expensive, aeromedical evacuations.^11,12 As many patients presenting with symptoms of possible ACS will not require hospital-based care, these potentially unnecessary patient transfers challenge finite health system and hospital resources; may cause avoidable hardship to patients; and may put patients, flight crews, and paramedics at risk in Canada’s often challenging geographic and weather conditions.

POCT for cTn pose an interesting opportunity to triage patients presenting with potential ACS in remote and rural community health care centres. These tests can be conducted close to the patient, often with handheld or desktop devices, provide results quickly (typically within 10 to 20 minutes),¹³ can be used without need for extensive medical-technical training, and many are approved for use in Canada.¹⁴ However, POCTs for cTn have been found to be less sensitive compared to laboratory-based assays,¹⁴ performance varies between devices, and staff training is required for implementation and quality control. A 2016 CADTH HTA¹⁴ of cTn POCTs in patients with symptoms suggestive of ACS in any setting concluded that cTn POCTs are not recommended when immediate access to central laboratory testing is available, but, in settings without immediate access to central laboratory testing, including rural or remote settings, cTn POCTs can be considered. A CADTH rapid response update (search date up to 2020),¹⁵ specific to cTnI POCTs, identified no new evidence.¹⁵

Why Is It Important to Do This Review?

Research and development in this field is rapidly evolving, including the availability of high-sensitivity cTn POCTs. As testing evolves, decision-makers are interested in understanding how cTnI POCTs may be used in community health care in rural and remote settings in Canada. Previous HTAs have identified limited research conducted in rural or remote settings. Most evidence and guideline recommendations have focused on cTn POCT use in EDs or hospitals in urban centres which differ in important ways in terms of patient demographics and efficient access to subsequent care. The 2023 European Society of Cardiology guidelines acknowledges that the clinical availability of validated high-sensitivity POCTs may alter the clinical utility of cTn POCT devices.⁷ As cTn testing is recommended as a component of suspected ACS-ADPs,^7-9and guidelines recommend validating ADPs within their intended context,⁹ reviewing the current research on clinical utility of these devices in community health care in rural and remote settings is important.

Objective

The objective of this rapid review is to examine recent research and evidence-based guidance on the use of cTnI POCTs within community health and primary care centres in rural and remote settings, where there may be limited or no efficient access to laboratory-based cTn measurements. Of particular interest for this review is whether and how cTnI POCTs can be used to help identify, in people presenting with symptoms of possible ACS, those who are likely to be at low risk for MI and for whom community care may be safe and effective.

Research Questions

1. What is the available information regarding the current use of point-of-care testing for cTnI in community health centres in rural or remote settings?

2. What is the clinical utility of point-of-care tests for cTnI when used in community health centres in rural or remote settings?

3. What are the evidence-based guidelines and best practices regarding the use of point of care tests for cTnI in community health centres in rural or remote settings?

Methods

An information specialist conducted a customized literature search of multiple sources and grey literature on November 28, 2024, balancing comprehensiveness with relevancy and limited to English-language documents published since January 1, 2009.

One reviewer screened citations, selected studies based on the inclusion criteria presented in Table 1, and extracted data from the included studies. We did not predefine the terms rural or remote and accepted definitions as employed by the study authors. This rapid review did not include a formal critical appraisal of included studies; if the results of such assessments were presented in included HTAs, this has been noted.

Appendix 1 presents a detailed description of methods.

Table 1: Selection Criteria

HTA = health technology assessment; RCT = randomized controlled trial; SR = systematic review.

Summary of Evidence

Quantity of Research Available

A total of 249 citations were identified in the literature search. Following screening of titles and abstracts, 205 citations were excluded and 44 potentially relevant reports from the electronic search were retrieved for full-text review. In addition, 8 potentially relevant publications were identified from the grey literature search and, 1 record referenced in a study. Of these potentially relevant articles, 46 publications were excluded. Appendix 1 presents the PRISMA¹⁶ flow chart of study selection.

This review includes 7 publications: 2 HTAs,^17,18 4 primary studies including 2 surveys of current practice,^19-22 and 1 report describing experiences with POCT programs.²³ Other relevant records were identified in the search but were excluded as they were either included in 1 of the HTAs (^24,25) or were systematic reviews (SRs) that did not provide additional relevant information.^14,26,27 No evidence-based guidelines that provided recommendations on the use of cTnI POCT in rural or remote community health centres were identified within our search period.

Summary of Study Characteristics

Appendix 2 contains detailed characteristics of the included studies

Research Question 1: Current Use of cTnI Point-of-Care Testing in Community or Primary Health Centres in Rural and Remote Settings

Our search identified no information on the current use of cTnI POCT in rural or remote community health care settings in Canada. We identified 2 point-of-care testing programs that include cTnI POCT in rural and remote settings – 1 in Australia and 1 in New Zealand.^19,20,23 Appendix 3 includes details of these programs extracted from the identified literature serve as examples of relevant programs. We also identified 2 surveys that assessed GPs’ current and desired use of cTnI POCT: 1 surveyed GPs from primary practices in 3 German federal states (n = 292 responses of 2,052 surveyed)²¹ with subgroup data for GPs from rural community practices (n = 84), and the other surveyed staff members (1 per site) from each one of 100 randomly selected primary health care clinics in KwaZulu-Natal, South Africa (100% response rate).²³ Some respondent demographic information was provided in the publications yet is not detailed here due to the low applicability of these studies for this review.

Research Question 2: Clinical Use of cTnI Point-of-Care Testing in Community or Primary Health Centres in Rural and Remote Settings

Study Designs, Populations, and Settings

Two HTAs^17,18 reporting 4 studies relevant to this review,^24,25,28,29 and 2 primary observational studies^19,20 examined the clinical utility of cTnI POCT in the settings of interest.

One HTA was conducted by the European Network for Health Technology Assessments (EUnetHTA)¹⁸ and the second, an update of the first with narrower eligibility criteria, was conducted by the Austrian Institute for Health Technology Assessment GmbH (AIHTA).¹⁷ Both had broader inclusion criteria than our rapid review: they assessed questions related to both cTn and another POCT (D-dimer to help rule-out deep vein thrombosis and pulmonary embolism); they included studies examining cTnT as well as cTnI, and they included settings beyond community care in rural and remote locations. Both searched for studies including adult patients with suspected non–ST-elevation acute MI. The EUnetHTA report included studies in both ambulatory and emergency settings, while the AIHTA report was limited to studies conducted in primary and community care. Both HTA teams used a stepwise approach to identify relevant evidence — first searching for SRs, HTAs, and clinical or diagnostic guidelines (published in English or German between 2009 and 2019,¹⁸ or 2019 and 2024¹⁴), then supplementing the search, as needed, to identify primary studies. The EUnetHTA report¹⁸ identified 2 SRs, 1 of which was the 2016 CADTH HTA,¹⁴ and 8 guidelines that contributed to their assessment of cTn POCT. The AIHTA¹⁷ update identified no new relevant SRs or guidelines and included 3 primary studies in 4 publications. Only studies relevant to this rapid review, 2 from each HTA,^24,25,28,29 will be described in this report.

The EUnetHTA report¹⁸ included 1 study reported in 2 publications assessing a POCT program implemented in 36 remote health or community service centres in Australia’s Northern Territory.^25,29 Staff at the relevant health centres were invited to participate in a satisfaction survey (n = 127) regarding their perceptions before and after implementation of the POCT program.

The other 2 included primary observational studies^19,20 also assessed Australia’s Northern Territory POCT Program, auditing clinical outcomes. Matthews et al. (2020)¹⁹ included data from up to 80 remote sites within this region, while Spaeth et al. (2017)²⁰ included data from 6 remote health centres and limited participants to those with a primary presentation of chest pain, normal ECG, and clinical symptoms suggestive of NSTEMI. Time from onset of symptoms to presentation was not reported in either publication. In this region, patients can be transferred to 1 of 2 hospitals, typically by airplane or helicopter, and the average distance from practice to the hospital is 275 km (range, 100 to 700 km).

The AIHTA report¹⁷ included 2 relevant uncontrolled observational studies, both of which were conducted in New Zealand, and one²⁸ is a pilot study of the other.²⁴ These 2 studies had similar eligibility criteria: the pilot study²⁸ included adult patients presenting to 1 of 12 rural family practices (n = 180 participants) for whom symptoms of suspected ACS began within 72 hours of presentation and transfer to hospital for serial cTn measurement was intended. The subsequent study²⁴ recruited from up to 29 sites (n = 1,205 participants) and, while it recruited from rural hospitals and general and urgent care practices, it was included in this review as eligibility was limited to patients who would have required transfer for an urgent hospital-based assessment if they had presented to a general or urgent care practice. In both studies, practices do not include specialist care or central laboratory services and could be hours from the nearest metropolitan hospital. Participant baseline characteristics were similar between these 2 studies for most risk factors, although Norman et al. (2022)²⁸ may have included a higher proportion of smokers and those with a family history of cardiovascular disease. Importantly, the study populations had different medians of time from pain onset to initial assessment: approximately 15 hours in Norman et al. (2022)²⁸ and approximately 4.5 hours in Miller et al. (2022).²⁴

Interventions and Comparators

Eligibility for inclusion in the 2 HTAs was limited to quantitative cTn POCT devices available in Europe. The AIHTA report¹⁷ intended to prioritize evidence from high-sensitivity cTn POCTs over non–high-sensitivity cTn POCTs but found no studies using the former. Both reviews considered all comparators of current diagnostic practice. Nearly all studies identified by the HTAs and this rapid review exclusively report using the i-STAT cTnI test and 3 studies specifically report using this as 1 component of a clinical decision pathway or ADP.^20,24,28 All publications described study or program-specific training and quality control measures.

Two studies^24,28 from the AIHTA report¹⁷ examined the use of cTnI POCT as part of the Rural Accelerated Chest Pain Protocol (RACPP), which was modified from a validated metropolitan ED chest pain ADP.^24,28 This ADP includes, among other assessments, ECG and cTn POCT measurements at presentation and at 2 hours. Both studies used the i-STAT cTnI test and one²⁴ also used the AQT90 FLEX cTnT test. To increase sensitivity, both used a lower test cut-off for i-STAT than the manufacturer’s upper recommended limit based on the 99th percentile. For a patient to be classified as low risk, the following was required: no red flags (e.g., crescendo angina, hemodynamic instability, or ongoing chest pain), absence of potentially significant ECG changes at 0 and 2 hours, an Emergency Department Assessment of Chest Pain Score³⁰ of less than 16, and serial cTn concentrations below the lower rule-out threshold at 0 and 2 hours (i-STAT: 0.04 mcg/L; AQT90: 18 ng/L). If all criteria were met, the patients were discharged home with follow-up as appropriate based on the clinician’s assessment. If these criteria were not met or a change of 0.02 mcg/L or more in cTnI levels was observed on the i-STAT test, patients were transferred to a referral centre or admitted to hospital.

Spaeth et al. (2017)²⁰ examined the use of cTnI as part of a modified standard care protocol similar to, but less specific than, that used in other studies (they state they used serial cTn measures at 0 and < 8 hours from presentation and did not state a cTnI concentration used to rule out MI).

Outcomes

The 2 HTAs^17,18 included outcomes as eligibility criteria. They did not prespecify outcome definitions or methods of measurement other than for major adverse cardiovascular events (MACE). The outcomes assessed in the HTAs (with primary studies reporting these outcomes also referenced) include:

• MACE,^17,18 a composite outcome, was defined in the AIHTA report as ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively, and all-cause mortality

• other safety outcomes (adverse events,^17,18 serious adverse events¹⁷)

• measures of diagnostic accuracy (specifically: sensitivity, specificity, positive and negative predictive value)¹⁷

• hospital or ED referrals or visits^17,18,20

• hospital admissions^17,18

• patient quality of life (QoL) or health-related quality of life^17,18

• patient satisfaction¹⁷

• staff satisfaction¹⁷

• treatment initiation¹⁸

• door-to-needle time^18,20

• turnaround time^18,20

• time to discharge¹⁸

• length of stay¹⁸

• further diagnostic testing¹⁸

• time to clinical decision or diagnosis.^18,20

Additional relevant outcomes planned in the included primary studies were:

• clinician adherence to pathway²⁸

• number of tests outside a defined critical action limit (i.e., a positive test) and clinical conditions of relevant patients.¹⁹

Research Question 3: Evidence-Based Guideline Recommendations on Use of cTnI Point-of-Care Testing in Community Health Care in Rural and Remote Settings

No evidence-based guidelines were identified that recommended best practices specific to cTnI POCTs in community health care and primary care settings in rural and remote locations.

Summary of Findings

Appendix 3 presents the main study findings.

Research Question 1: Current Use of cTnI Point-of-Care Testing in Community Health Centres in Rural and Remote Settings

Our search identified no information on the current use of cTnI POCT in rural or remote community health care settings in Canada. Appendix 3 (Table 5) includes details of 2 point-of-care testing programs in rural or remote settings that include cTnI POCTs; 1 in Australia and 1 in New Zealand.^19,20,23 While not exhaustively searched and identified, these examples serve to provide approaches to structured governance and oversight, training and quality control, challenges experienced in these settings, and may inform the use of these devices in Canada. We also identified 2 surveys on GPs’ current and desired use of cTnI POCTs, in South Africa and Germany which, given health system and population dispersion differences, have limited applicability to the setting in Canada.

Current Use of cTn POC Devices

Data on the current use of cTn POCTs comes from 2 surveys and 1 program evaluation (Appendix 3, Table 6). Both surveys assessed the current and desired use of POCTs more generally, including specific questions regarding cTn POCTs. Matthes et al. (2023),²¹ mailed invitations to more than 2,000 GPs in urban and rural community practices in 3 German federal states in 2022; the total response rate was 14.5%. Thirty-nine percent of GPs from rural community practices reported regular use of cTn POCTs, 35.4% reported infrequent use, and 25.6% reported no use. The authors reported no statistically significant difference between rural and urban GPs’ use of cTn POCTs. Mashamba-Thompson et al. (2018)²² surveyed staff at 100 randomly selected rural primary health care clinics in KwaZulu-Natal, South Africa. Although the survey explicitly asked about current and desired use of cTn POCTs, the authors did not present responses about this test in the publication. The presentation of results was limited to the following: most frequently used tests, top 20 desired POCTs, and top 10 desirable POCTs by disease class, of which cTn POCTs were not rated. Based on the limited information, we can only conclude that cTn POCTs were not one of the most frequently used or desired tests, with less than 10% of respondents from this study indicating desired future need for cTn POCTs.

The 2020 report evaluating Australia’s Northern Territory POCT Program, implemented in 2008, showed a steady increase in cTnI POCT use over the first 4 years of the program.¹⁹

Context: Distance to Tertiary Care

In Australia’s Northern Territory POCT Program, 97.5% of remote health clinics are considered very remote. The region includes 2 tertiary care hospitals with an average distance of 275 km (range, 100 to 700 km) from practices to hospitals.¹⁹ Distances between centres of the various POCT programs in New Zealand were not described by Herd et al. (2021).²³

The distance or time from study sites to specialist care and laboratory services was also described in the following included studies:

• Miller et al. (2022):²⁴ from 45 minutes to 4 hours and 20 minutes

• Norman et al. (2022):²⁸ 0.01 km to 62.7 km (1 to 79 minutes) to a rural hospital and 32.0 to 178.4 km (30 to 152 minutes) to a base hospital

• Mashamba-Thompson et al. (2018):²² the mean distance was 41.4 (standard deviation = 42.8) km, with 40% of practices within 10 km of the hospital.

Context: Method of Patient Transportation to Tertiary Care

We identified little information on transport methods from rural to tertiary care centres. Reports on Australia’s Northern Territory POCT Program state that patients can be transferred to 1 of 2 hospitals, typically by airplane or helicopter.^19,20,25,29 Additionally, a report²⁴ from a study included in 1 HTA¹⁷ noted that 1 study site may require transportation by helicopter or boat, but the mode of transportation was not specified for other sites.

Research Question 2: Clinical Use of cTnI Point-of-Care Testing in Community Health Centres in Rural and Remote Settings

We identified 2 HTAs^17,18 and 2 primary observational studies^19,20 examining the clinical utility of cTnI POCTs in community health or primary care centres in rural and remote settings. Three studies (2^24,28 included in 1 HTA¹⁷ and 1 primary study²⁰) described cTnI POCT use as part of an ADP (i.e., a clinical decision algorithm) and the results suggest that a suspected ACS-ADP using cTnI POCTs may be beneficial to identify low-risk patients and safely avoid unnecessary referrals or patient transfers. However, the evidence of clinical utility in these settings comes from a few uncontrolled observational studies focused primarily on 1 cTnI POCT (i-STAT test) used within specific ADPs. As such, the results cannot be translated to other cTnI POCT devices nor those used within other ADPs. It is unclear if the results are valid in other rural and remote settings. Limited information was provided on patients’ acceptability and satisfaction with care.

Major Adverse Cardiovascular Events

One HTA¹⁷ identified 2 uncontrolled studies^24,28 assessing MACE at 30 days. The HTA authors assessed these studies to be at serious and critical risk of bias. The 2 studies used similar ADPs, using the RACPP to stratify patient risk and guide patient transfer and hospital admission decisions. Both studies reported no MACE in patients designated as low risk and at least 1 MACE was experienced by 13%²⁸ and 23%²⁴ of participants designated as non–low risk.

Measures of Diagnostic Accuracy of RACPP

One HTA¹⁷ identified 2 uncontrolled studies^24,28 assessing the diagnostic accuracy of the RACPP to predict 30-day MACE. The HTA authors assessed these studies to be at serious and critical risk of bias. The results for Miller et al. (2022)²⁴ and Norman et al. (2022),²⁸ respectively, are as follows:

• sensitivity: 100% (95% confidence interval [CI], 97.3% to 100%) and 100.0% (95% CI, 70.1% to 100.0%)

• negative predictive value: 100% (95% CI, 99.2% to 100%) and 100.0% (95% CI, 96.7% to 100.0%)

• specificity: 50.7% (95% CI, 47.5% to 53.9%) and 63.8% (95% CI, 56.4% to 70.6%)

• positive predictive value: 23.0% (95% CI, 19.8% to 26.6%) and 12.5% (95% CI, 6.7% to 22.1%).

Hospital Referrals, Admissions, Patient Evacuations

One HTA,¹⁷ including 2 uncontrolled studies,^24,28 and 1 other primary study²⁰ assessed hospital referrals, admissions, or patient evacuations (Appendix 3, Table 9). Miller et al. (2022)²⁴ and Norman et al. (2022)²⁸ reported that 91.8% (95% CI, 88.8% to 93.9%) and 100% of patients designated as low risk for MI, respectively, were never transferred or admitted to hospital (i.e., were discharged home). Spaeth et al. (2017)²⁰ included 2 outcomes in this domain. The first outcome was defined as the number of patients designated as cTnI negative within the context of a POCT pathway (i.e., low risk) compared to those who were cTnI positive who were evacuated (10% versus 100%, respectively). The second outcome was based on a retrospective chart analysis by a senior rural medical practitioner who predicted whether patients would have been evacuated at the time of their assessment had cTnI POCTs not been available. The authors reported that cTnI POCTs might have helped avoid 38% of evacuations due to an inability, in their absence, to rule out cardiac involvement; all patients who were cTnI negative who were evacuated would still have been evacuated without cTnI POCTs due to their condition; and of those who were cTn-positive (n = 7), approximately one-half would not have been evacuated without cTnI POCT testing and would likely have experienced a poorer outcome.

Time to Diagnosis, Time to Treatment, and Door-to-Needle Time

One retrospective primary study²⁰ reported both the time from cTnI POCT administration to diagnosis and to treatment. The authors presented summary measures based on whether patients received a single POCT or serial cTnI POCTs, had positive or negative results, and were evacuated or not. As the numbers are small within most groups and interquartile ranges are wide, conclusions cannot be drawn. Table 10 and Table 11 contain the summary measures by group.

Patient Satisfaction

One HTA¹⁷ identified 1 observational study²⁸ assessing patient satisfaction with their care when care was guided by the RACPP that included cTnI POCT (Appendix 3, Table 12). Patient response rate was 75% (of 148 participants included in this analysis) and most patients reported “Good” or “Excellent” overall satisfaction with the service they received (94.0% of 67 low-risk patients and 95.5% of 44 non–low-risk patients, including 37 of the latter who were transferred to hospital).

Staff Satisfaction

The 2 HTAs^17,18 identified 2 studies reported in 3 publications that assessed staff satisfaction (Appendix 3, Table 13).^25,28,29 Norman et al. (2022)²⁸ did not define this outcome and reported that “The pathway was considered feasible and acceptable by the general practices to the extent that it has been maintained as the standard of care in the participating centres.” Shephard et al. (2012, 2014)^25,29 defined this outcome as “staff satisfaction with pathology services” and collected data using online questionnaires approximately 1 year after introducing the i-STAT POCT program. The results were based on recalled satisfaction for both before implementation and after implementation outcomes. The response rate was 31% (of 127 potential respondents) and results suggested perceived improvements between overall satisfaction of cTn testing in general and timeliness of acute test results before implementation (with laboratory-based assays) versus after implementation (with POCT-based assays). Each question had missing data and results should be interpreted with caution.

Adherence to Pathway

One HTA¹⁷ identified 1 uncontrolled observational pilot study²⁸ assessing physicians’ and patients’ adherence to the RACPP (Appendix 3, Table 14). They reported adherence to the protocol for 95.5% of the 111 patients designated as low risk by the ADP and 81.2% of the 69 patients designated as non–low risk. In the low-risk group, 4 participants did not undergo the 2-hour assessment due to a diagnosis of non-cardiac chest pain and 1 refused to remain at the practice. In the non–low-risk group, 13 participants were not transferred for hospital assessment, against pathway guidance; none of these patients had elevated cTnI or experienced MACE within 30 days.

Proportion of cTnI Tests Outside the Defined Critical Action Limits and Corresponding Patient Clinical Condition

One study¹⁹ evaluating Australia’s Northern Territory POCT Program examined the number of tests outside the critical action limits (i.e., positive tests) and the diagnosis of corresponding patients (Appendix 3, Table 15). Three percent of 1,398 cTnI POCTs administered between September and December 2019 were outside the defined clinical limits (> 0.09 ng/m). Corresponding patient clinical conditions included MI (n = 34; 2.4%), chronic kidney disease related, (n = 4; 0.3%), atrial fibrillation (n = 3; 0.2%), respiratory related (n = 2; 0.1%), and hypokalemia (n = 2; 0.1%).

Outcomes Predefined in HTAs, Not Reported in Included Studies

The 2 HTAs sought evidence regarding the following outcomes and no relevant evidence was identified: treatment initiation, health or patient-related QoL, adverse events, and serious adverse events, turnaround time, time to discharge, length of stay, and further diagnostic testing.

Research Question 3: Evidence-Based Guideline Recommendations on Use of cTnI Point-of-Care Testing in Community Health Care in Rural and Remote Settings

Our electronic database and grey literature search did not identify evidence-based guideline recommendations specific to the use of cTnI POCTs in community health or primary care centres in rural or remote settings.

Limitations

Our search identified no information regarding the current use of cTnI POCTs in rural and remote settings in Canada. Surveys that were identified on current and desired use of cTnI POCTs, conducted in Germany and South Africa, are not directly applicable to the context in Canada due to population dispersion and health systems differences. We identified 2 POCT programs, 1 in Australia and 1 in New Zealand, that specifically reference cTnI POCT use in community and primary care centres in rural or remote jurisdictions. The applicability of these programs to the context in Canada, while promising, will need to be considered. Other POCT programs and implementation guidelines identified during this assessment (within or outside the context in Canada) either did not specifically mention or assess cTnI POCTs, did not describe the context as community health or primary care centres in rural and remote settings (e.g., mixed settings, rural hospitals), or did not meet other review eligibility criteria.

We also identified limited evidence to inform the clinical utility of cTnI POCTs in community health centres in remote and rural settings in Canada. The included HTAs appear to be well conducted yet few primary research studies were identified, they lacked a control group, and were assessed as having high risk of bias (by the authors of the HTA). The included studies primarily focused on 1 device, i-STAT, which is available in Canada. While the results of included studies are promising, the evidence is not applicable to other devices due to variations in diagnostic accuracy and recommended diagnostic cut-off values between devices. The included clinical utility studies also considered cTnI POCTs in the context of 2 ADPs and, given cTnI POCT clinical utility is dependent on the ADP guiding patient management, the results of the studies included in this review should not be considered applicable outside of the ADP within which they were tested. Importantly, no study assessed high-sensitivity cTnI POCT devices.

While some existing guidelines provide specific recommendations with respect to components of the review questions (e.g., recommendations on the use of cTn POCTs without a specific setting or not specific to rural and remote settings), we did not identify an evidence-based clinical guideline providing recommendations specific to community health care in rural and remote settings for this rapid review.

Conclusions and Implications for Decision-Making or Policy-Making

This rapid review evaluated the evidence on the current use, clinical utility, and guideline recommendations regarding cTnI POCTs in rural and remote community health settings. Seven publications were included in the review: 2 HTAs (from which 3 primary studies in 4 reports were applicable), 4 primary observational studies, and 1 report describing experiences with POCT programs in New Zealand. The overall evidence-base to inform the use of cTnI POCT in these settings is limited and no studies were conducted in Canada. The results suggest that cTnI POCTs, when used within the context of an ACS-ADP, have the potential to identify patients who were low-risk (high sensitivity and negative predictive value), reduce unnecessary referrals or transfers, and increase patient and staff satisfaction when there is limited or no efficient access to laboratory-based results. However, the studies we identified did not include control groups and have risks to their validity (as assessed by the authors of the HTA). As such, while promising, the results should be considered in this context.

Our search identified 2 current POCT programs that include cTnI testing — 1 implemented in Australia’s Northern Territory and 1 in New Zealand. These programs may be informative to the context in Canada given the similarities between health care systems and population dispersion. The experiences and challenges described in relation to these programs^19,31 highlight the importance of strong governance and oversight structures; continuing resource needs for training, accreditation, and quality control; advantages of centralized data collection and monitoring; and the challenges with high staff turnover in rural and remote regions, the latter also noted in Canada.^11,27

The limited evidence on the clinical utility of cTnI POCTs identified in this review comes from studies conducted in New Zealand and Australia and it is not clear whether the results may be applicable to rural and remote community health care in Canada. Research on cTnI POCTs is more established in other settings (EDs, prehospital care, or emergency medical services) and some studies conducted within rural hospitals (e.g., Dee et al.³²) may also be informative; however, potential differences in the patient population, such as underlying patient risk⁴ and access to subsequent care, make it challenging to translate these results to rural and remote community care settings. We also acknowledge there are different levels of rurality and remoteness and that decisions and preferences concerning availability of POCTs may need to vary depending on the setting.

Importantly, cTnI testing is not assessed as an isolated intervention. Rather, it is assessed within the context of suspected ACS-ADPs, in alignment with current guideline recommendations.^7-9 These typically incorporate ECG results, clinical risk scores (e.g., based on symptoms, age, sex, history), and time points and cut-off values for cTnI testing (often laboratory-based) to guide patient management. Guidelines recommend validating suspected ACS-ADPs within the intended context⁹ as numerous factors can affect their utility, including time from symptom onset to presentation and local prevalence of other risk factors, patient transport protocols, staff training, patient preferences, and staff and patient fidelity with the protocols. Both the authors of the most recent HTA¹⁷ and those of largest prospective patient-focused study²⁴ conclude that further assessment is needed (e.g., larger studies, RCTs, longer follow-up, validation of ADPs in the settings of interest). Additionally, limited evidence was available on patient-focused outcomes such as QoL and satisfaction with care and these would be valuable additions to future research. The included evidence was almost all conducted using i-STAT cTnI, the results of which are not generalizable to other cTnI POCT devices, and no studies assessed a high-sensitivity cTnI POCT device; this evolving technology may affect POCT recommendations.⁷

Our initial search for evidence-based guidelines did not identify any specific recommendations regarding the use of cTnI POCTs in rural and remote community care centres. Some reports included evidence-based recommendations on cTn testing but not specific to the settings of interest,³³ while others provided recommendations but did not describe both a systematic search for evidence and a defined consensus process.^27,34 The 2023 European Society of Cardiology Guidelines acknowledged this is a rapidly evolving field and that an update of current recommendations may be required with the introduction of high-sensitivity cTn POCT devices in clinical settings.

Since completion of this rapid review, the anticipated 2025 update³⁵ to the 2016 ACS guidelines⁹ by the National Heart Foundation of Australia and the Cardiac Society of Australia and New Zealand has been released. While no recommendation specifically guides the use of cTnI POCTs in community health or primary care centres in rural and remote settings, this guideline describes factors associated with all these variables separately and includes considerations for care of priority populations including those living in remote areas. Specifically, authors recommend use of high-sensitivity cTn assays, wherever possible, versus contemporary (non-high sensitivity) cTn assays and, as with previous guidance, they recommend the use of an evidence-based clinical decision pathway. The authors discuss considerations for testing and interpreting results based on other factors, including age, race, and the effect of sex hormones for transgender individuals. Authors note that cTn POCTs may lead to more timely management with comparable safety to laboratory-based assays and that emerging evidence supports rapid assessment using high-sensitivity cTn assays. They also acknowledge that the evidence-base is rapidly evolving and that the use of POCTs with ADPs, including in primary care, may become more common. No specific recommendation is provided regarding use of cTn POCTs in rural and remote settings. The authors recommend, more broadly, the establishment of centralized support systems for regional and remote health services to facilitate prompt assistance with ECG interpretation and access to cTn results when onsite access is not available.

Overall, while the results of this rapid review suggest that, when used within the context of an ACS-ADP, cTnI POCTs have the potential to identify patients who were considered at low-risk and reduce unnecessary referrals or transfers for people presenting with symptoms of ACS in community health care in rural and remote settings (with limited access to laboratory-based results), there are concerns about the validity and applicability of the evidence. We found no evidence from studies conducted in Canada, the evidence was limited primarily to 1 device, and it was assessed within uncontrolled observational studies. As such, when considering implementation of these devices, it would be advantageous to first assess them within the context of a suspected ACS-ADP in the settings of interest. This is important to account for variables such as the underlying community cardiac risk factors, patient experience, available resources, and availability of trained, qualified personnel. The advent of high-sensitivity cTn POCTs holds promise to help overcome some of the concerns with currently available non–high-sensitivity -cTnI POCTs and future research will be important to better understand their utility. Health care decision-makers will ultimately need to balance the limited existing and emerging evidence with the challenges of their current standard of care.

Acknowledgements

We thank our content expert reviewer, Alexander Hoechsmann, BA, BSc, MD, Emergency Physician, Island Health, for his consultation on this report.

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Appendix 1: Detailed Methods and Selection of Included Studies

Please note that this appendix has not been copy-edited.

Literature Search Methods

An information specialist conducted a literature search on key resources including MEDLINE, the Cochrane Database of Systematic Reviews, the International HTA Database, the websites of HTA agencies in Canada and major international HTA agencies, as well as a focused internet search. The search approach was customized to retrieve a limited set of results, balancing comprehensiveness with relevance. The search strategy comprised both controlled vocabulary, such as the National Library of Medicine’s MeSH (medical subject headings), and keywords. Search concepts were developed based on the elements of the research questions and selection criteria. The main search concepts were cTnI POCT and the rural or remote setting. To address question 3, search filters were applied to limit retrieval to HTAs, SRs, meta-analyses, or indirect treatment comparisons and guidelines; no filters were applied to limit the retrieval by study type for questions 1 and 2. The search was completed on November 28, 2024, and limited to English-language documents published since January 1, 2009. Internet links were provided, where available. We provide the search strategy for MEDLINE in Table 2.

Table 2: Search Strategy for Ovid MEDLINE (1946 to November 27, 2024)

Selection Criteria and Methods

One reviewer screened citations and selected studies. In the first level of screening, titles and abstracts were reviewed and potentially relevant articles were retrieved and assessed for inclusion. The final selection of full-text articles was based on the inclusion criteria presented in Table 1.

Exclusion Criteria

Articles were excluded if they did not meet the selection criteria outlined in Table 1, they were duplicate publications or were published before 2009. SRs in which all relevant studies were captured in other more recent or more comprehensive SRs were excluded. Primary studies retrieved by the search were excluded if they were captured in 1 or more included SRs. Guidelines with unclear methodology were also excluded. Studies conducted in urban settings, hospitals or EDs or mixed settings, unless results were reported separately for rural and remote settings, were not eligible.

Critical Appraisal of Individual Studies

We did not conduct a formal critical appraisal of individual studies for this review. The limitations of the included studies are discussed.

Figure 1: Selection of Included Studies

HTA = health technology assessment; POCT = point-of-care test; SR = systematic review.

Appendix 2: Characteristics of Included Publications

Table 3: Characteristics of Included Health Technology Assessments

ACS = acute coronary syndrome; AE = adverse event; AIHTA = Austrian Institute for Health Technology Assessment; cTnI = cardiac troponin I; cTnT = cardiac troponin T; ED = emergency department; EUnetHTA = European Network for Health Technology Assessment; HTA = health technology assessment; hs = high sensitivity; MA = meta-analysis; MACE = major adverse cardiovascular events; MI = myocardial infarction; NSTE-ASC = non–ST-segment elevation acute coronary syndrome; POCT = point-of-care test; QoL = quality of life; RACPP = Rural Accelerated Chest Pain Pathway; RCT = randomized controlled trial; SAE = serious adverse event; SR = systematic review; STEMI = ST-elevation acute myocardial infarction.

Note: This table has not been copy-edited.

^aMACE is defined as a combined end point of ACS, percutaneous coronary intervention, coronary artery bypass grafting, coronary angiography revealing procedurally correctable stenosis managed conservatively and all-cause mortality.

Table 4: Characteristics of Included Primary Clinical Studies

ACS = acute coronary syndrome; AIHTA = Austrian Institute for Health Technology Assessment; AMI = acute myocardial infarction; CAD = cardiovascular disease; COI = conflict of interest; cTn = cardiac troponin; cTnI = cardiac troponin I; cTnT = cardiac troponin T; GP = general practitioner; ECG = electrocardiogram; ED = emergency department; EDACS = Emergency Department Assessment of Chest Pain Score; EUnetHTA = European Network for Health Technology Assessment; IQR = interquartile range; LR = likelihood ratio; MACE = major adverse cardiovascular events; NA = not applicable; NPV = negative predictive value; NR = not reported; NSTEMI = non–ST-elevation myocardial infarction; POCT = point-of-care test; PPV = positive predictive value; RACPP = Rural Accelerated Chest Pain Pathway; SD = standard deviation; STEMI = ST-elevation acute myocardial infarction; URL = upper reference limit.

Note: This table has not been copy-edited.

^aTerminology from the original source.

Appendix 3: Main Study Findings

Please note that this appendix has not been copy-edited.

Table 5: Point of Care Testing Programs Identified in this Review^a

cTnI = cardiac troponin I; DHB = District Health Board; ED = emergency department; NT = Northern Territory; POCT = point-of-care test.

^aIs not intended to be interpreted as a complete list of POCT programs.

^bTerminology from the original source.

Table 6: Summary of Findings by Outcome — Rural GP Use or Desired Use of Troponin POCTs

cTnI = cardiac troponin I; cTnT = cardiac troponin T; GPs = general practitioners; NR = not reported; POCT = point-of-care test.

Table 7: Summary of Findings by Outcome — Major Adverse Cardiovascular Events Within 30 days of Index Presentation and Diagnostic Accuracy of Accelerated Diagnostic Pathway

AIHTA = Austrian Institute for Health Technology Assessment; CI = confidence interval; cTnI = cardiac troponin I; ECG = electrocardiogram; EDACS = Emergency Department Assessment of Chest Pain Score; LR- = negative likelihood ratio; LR+ = positive likelihood ratio; MACE = major adverse cardiovascular events; MI = myocardial infarction; NPV = negative predictive value; NR = not reported; NZ MOH = New Zealand Ministry of Health; POCT = point-of-care test; PPV = positive predictive value; RACPP = Rural Accelerated Chest Pain Pathway; Sens = sensitivity; Spec = Specificity.

Table 8: Summary of Findings by Outcome — Agreement Between POCT and Laboratory Measured Cardiac Troponin Concentrations

AIHTA = Austrian Institute for Health Technology Assessment; cTnI = cardiac troponin I; hs-troponin = high-sensitivity troponin; MACE = major adverse cardiovascular events; POCT = point-of-care test.

Table 9: Summary of Findings by Outcome — Hospital Referrals, Admissions, Evacuations^a

AIHTA = Austrian Institute for Health Technology Assessment; CDS = Central Data Station; CI = confidence interval; cTnI = cardiac troponin I; cTnT = cardiac troponin T; ECG = electrocardiogram; EDACS = Emergency Department Assessment of Chest Pain Score; MACE = major adverse cardiovascular events; NZ MOH = New Zealand Ministry of Health; NR = not reported; POCT = point-of-care test; RACPP = Rural Accelerated Chest Pain Pathway.

^aIncludes both actual evacuation data or equivalent and clinical judgment of hypothetical evacuation status, depending on study.

Table 10: Summary of Findings by Outcome — Time to Diagnosis

CDS = Central Data Station; cTnI = cardiac troponin I; ECG = electrocardiogram; IQR = interquartile range; NR = not reported; POCT = point-of-care test; PCIS = Primary Care Information System.

Table 11: Summary of Findings by Outcome — Time to Treatment

CDS = Central Data Station; cTnI = cardiac troponin I; ECG = electrocardiogram; IQR = interquartile range; NR = not reported; POCT = point-of-care test; PCIS = Primary Care Information System.

Table 12: Summary of Findings by Outcome — Patient Satisfaction

AIHTA = Austrian Institute for Health Technology Assessment; cTnI = cardiac troponin I; ECG = electrocardiogram; EDACS = Emergency Department Assessment of Chest Pain Score; POCT = point-of-care test; RACPP = Rural Accelerated Chest Pain Pathway.

Table 13: Summary of Findings by Outcome — Staff Satisfaction

AIHTA = Austrian Institute for Health Technology Assessment; cTnI = cardiac troponin I; ECG = electrocardiogram; EDACS = Emergency Department Assessment of Chest Pain Score; EUnetHTA = European Network for Health Technology Assessment; NR = not reported; NT POCT program: Northern Territory Point-of-Care Testing Program; POCT = point-of-care test; RACPP = Rural Accelerated Chest Pain Pathway.

Table 14: Summary of Findings by Outcome — Adherence to Pathway

AIHTA = Austrian Institute for Health Technology Assessment; cTnI = cardiac troponin I; ECG = electrocardiogram; EDACS = Emergency Department Assessment of Chest Pain Score; MACE = major adverse cardiovascular events; NR = not reported; POCT = point-of-care test; RACPP = Rural Accelerated Chest Pain Pathway.

Table 15: Summary of Findings by Outcome — Number (%) of cTnI Test Results Outside “Defined Critical Actions Limits” and Patient Clinical Conditions

cTnI = cardiac troponin I; NR = not reported; POCT = point-of-care test.