The pathway to diagnosis and follow-up care for atrial fibrillation in Sri Lanka: a descriptive longitudinal study

Patient and public involvement

Patient partners were not involved in the design or conduct of this study.

Ethics and consent

Ethical approval was received on 8^th July 2020 in Sri Lanka from the Ethical Review Committee, Faculty of Medicine and University of Jaffna, Sri Lanka (Reference number/ERC/19/ 107/NDR/0218). Written informed consent was provided from all included participants either through signature or thumbprint on paper if illiterate.

Study design

This study was part of a multi-country study aimed to identify the AF care pathway in Brazil, China and Sri Lanka using a prospective study design²³. Adults (≥18 years) with a confirmed diagnosis of AF or an arrhythmia likely to be AF who were visiting any of the included healthcare facilities for AF care and spoke the local language (Tamil) were considered eligible. Patients were excluded if they had any hearing or cognitive impairment.

Setting

Patients were recruited from the Northern Province in Sri Lanka. The estimated population in the Northern Province is 1.2 million and comprises five districts, including urban, rural and peri-urban settings²⁴. Universal healthcare is available across all of Sri Lanka, with care and medications free to all citizens; however, in the Northern Province, only one tertiary hospital (Jaffna Teaching Hospital) exists with cardiologists and 12-lead echocardiogram facilities. Participants were recruited from Jaffna Teaching Hospital (part of University of Jaffna) within the A&E department, anticoagulation clinic and the medical clinic. Sex differences were not taken into the consideration in the study design as the study primary aim was to understand where people with AF get diagnosed, where they receive follow-up care and how the COVID-19 pandemic impacted their care, which is not impacted by sex differences.

Data collection

A research fellow with a master’s degree in applied epidemiology and seven trained research assistants with degrees in medicine, Siddha medicine or nursing conducted consecutive recruitment by approaching patients in the A&E department, anticoagulation clinic and medical clinic, inviting all eligible patients to participate. The anticoagulation clinic was visited on Tuesdays (the clinic’s dedicated day for patients on warfarin to conduct INR tests), whereas the medical clinic was visited weekdays and weekends randomly throughout the study period due to the clinic not having a designated day for AF care. If a patient agreed to take part, they provided written informed consent and baseline data was collected during their wait to see the doctor.

Baseline data was completed between October 2020 and March 2021. Follow-up data was completed in person at the specialised clinics or by phone for each participant between April 2021 and June 2021, at least three months after baseline data was collected for each participant. Two questionnaires were developed and adapted from studies in Mongolia²⁵ and India²⁶ to collect quantitative data on AF diagnosis, management and care. The baseline questionnaire aimed to capture how and when an AF diagnosis was received, whereas the follow-up questionnaire aimed to capture patients’ healthcare seeking behaviours and the care and medication received since baseline; the follow-up questionnaire was administered at least two months following the baseline questionnaire. The questionnaires were translated into Tamil, then back translated into English to check for accuracy. Before the study commenced, the questionnaires were piloted with four patients in Sri Lanka; no major changes resulted from piloting the tools²³. KoBoCollect, (version v2021.2.4.) an open-source software platform used in many LMICs, was used to collect all data²⁷.

Prior to recruitment, the COVID-19 pandemic occurred, with Sri Lanka experiencing a distinct wave of cases during the recruitment period. During this time, partial or complete lockdowns were implemented and limitations on travel and healthcare provision were imposed across the country. However, clinic visits in the hospital (where patients were recruited) remained normal during the entirety of the study and data collection was feasible following arrangements to maintain social distancing.

To ensure we captured how the aspects of the pathway had changed due to the pandemic, we adapted the follow-up questionnaire to include questions on the impact of COVID-19 on clinic visits, receiving medications and INR tests. The original protocol for the study was amended to add the secondary aim of identifying the impact of the pandemic on the AF care pathway in Sri Lanka to ensure we present findings from the original aims within the context of the emergent pandemic.

Statistical methods

IBM SPSS Statistics (RRID:SCR_016479) 27.0 (IBM Corp., Armonk, N.Y., USA) was used for all analyses. Descriptive statistics were used to present baseline and follow-up data. Continuous variables are presented as mean with standard deviation (±SD) and categorical variables are presented as frequencies and proportions.

The sample size calculation was based upon achieving an adequate precision for the primary aim of the study of identifying the number of AF diagnoses in primary care settings. A minimum sample size of n=205 was calculated based on a formula for accurately estimating the proportion in an unknown population with ±5% accuracy at the 95% confidence level (α=0.05)²⁵. After a 15% increase was added to the sample size to account for loss to follow-up, the final required sample size was 236.

Participant characteristics

A total of 152 patients with AF were identified from the A&E and outpatients clinics located at the Jaffna Teaching Hospital (Figure 1). One patient was excluded due to a hearing impairment, though the remaining 151 patients provided consent and were included in the study. Of these, 119 were recruited from the anticoagulation clinic, 30 from the medical clinics and two from the A&E. None of the participants were receiving first-time AF care. Two participants were lost following baseline data collection. Thus, 149 participants completed the follow-up questionnaire. Among them, 144 were followed up in person and five were followed up by phone. The median age of the participants was 57 years old (IQR=49-67) and the majority of participants were female (70%), married (62%), literate (97%), had completed primary or secondary school (81%) and identified as Sri Lankan Tamil (97%) (Table 1). On average, participants were diagnosed with AF 13 years prior to data collection (mean=156.7 months, SD=104.2; median=159 months, IQR=80-280) (Table 2).

Figure 1. Study flow diagram.

AF, atrial fibrillation.

Patient pathway

Most participants (99/151, 66%) were diagnosed in the Jaffna Teaching Hospital; among them more than half (57/99, 58%) were diagnosed in the A&E, accounting for 38% (57/151) of the total sample (Figure 2). Of those diagnosed at Jaffna Teaching Hospital, 39% (39/99) were diagnosed in the inpatient department, whereas only 3% (3/99) were diagnosed in the outpatient department, accounting for 26% (39/151) and 2% (3/151) of the total sample, respectively. No one was diagnosed with AF in an inpatient department within a base or district general hospital (i.e., secondary care); however, 17% (26/151) were diagnosed in an outpatient department located in a secondary healthcare facility. One in six (24/151, 16%) participants were diagnosed with AF in a private healthcare facility and 1% (2/151) was diagnosed outside the country.

Figure 2.

(A) Place of AF diagnosis and (B) place of AF care (denominator = 184 i.e., number of total AF care visits since baseline). ^a Other includes participants that were diagnosed in a different country. AF, atrial fibrillation.

Most participants (114/151, 75%) were advised to attend the anticoagulation clinic for follow-up care (Table 3). Indeed, only 3% (4/149) of participants had no follow-up care during the study period. The remaining participants had a total of 184 AF-related care visits with healthcare professionals, averaging 1.3 visits per participant. Two healthcare visits (1%) were to A&E due to a transient ischaemic attack. Most other healthcare visits for AF care were at the anticoagulation clinic (119/184, 65%), followed by 16% (30/184) at the medical clinic, 7% (12/184) at a secondary care outpatient department and 11% (21/184) at a private healthcare facility (Figure 2). At the time of study follow-up, the average number of days since the participants’ last visit to the anticoagulation and medical clinic was 57.5 days (SD=23.9) and 39.6 days (SD=16.7), respectively. This was higher for those that had visited secondary (82.5; SD=17.5) or private healthcare facilities (81.0; SD=18.6 for private outpatient department and 75.0; SD=23.2 for private small clinic) (Table 3).

Medication and INR tests

Nearly all (150/151, 99%) participants were on blood thinning medication at baseline (Table 3). The one participant not on treatment was contraindicated due to their comorbid conditions. A total of 80% (121/151) of participants were taking rate or rhythm control medications. This included digoxin (75/121, 50%), beta blocker (46/121, 30%), calcium channel blocker (16/121, 10%), aspirin (8/121, 5%) and amiodarone (7/121, 5%) medication. At follow-up, 92% (138/149) of participants said they had taken an INR test since baseline. Although the majority (122/149, 82%) of participants stated that they can easily get warfarin from Jaffna Teaching Hospital or pharmacy, 17% (25/149) said it is not easy to access warfarin, likely due to limitations caused by the pandemic.

Impact from the COVID-19 pandemic

Overall, 39% of participants (58/149) said that their visits to the specialised clinics, getting medication and INR tests were adversely impacted during the COVID-19 pandemic (Table 3). Most of these participants had less visits than usual (33/58, 57%) and some had longer (total time) healthcare visits (9/58, 16%). Similarly, the interval between INR tests became longer (51/58, 88%) and some stopped taking tests during this time because they stopped taking their medication (6/58, 10%). Prescriptions for anticoagulation medication were not attainable for 17% (10/58) of participants and they were delayed for 36% (21/58) of participants. A further 22% (13/58) of participants said the medication was not available from the private pharmacies during this time and 24% (14/58) had their medication delivered to them by ambulance, public health staff or post.

Many participants expressed that the pandemic adversely impacted their visits (22/58, 38%), medication (23/58, 40%) and INR tests (23/58, 40%) because they feared getting COVID-19 or they were shielding, isolating or quarantining. Limited available public transportation, reduced hours or closure of healthcare facilities, enforcement of curfews or lockdowns and doctors being difficult or unavailable to contact (especially in the medical clinics) were additional reasons participants said the pandemic adversely impacted their clinic visits and access to anticoagulation medication and INR tests.

Strengths and limitations

This study was conducted at the only tertiary hospital in the Northern Province that has cardiologists and can conduct 12-lead echocardiogram tests. Thus, most patients with AF in the province that retain AF care from government facilities, must visit Jaffna Teaching Hospital for care³⁶. Our sample is therefore largely representative of all patients with AF receiving government-funded care in the region. However, the study was subject to a few limitations. The required sample size for the study was not met. This was mainly due to recruitment limitations as described in a previous publication²³; although, lost to follow-up was minimal and this is a purely descriptive study. Therefore, these limitations do not largely impact the conclusions we could draw from our sample regarding our objectives particularly since one of our key findings is that primary care was absent in the diagnosis and management of AF. Most participants were diagnosed with AF more than 10 years prior to baseline and therefore the place of diagnosis may not reflect current practice and therefore should be interpreted with caution. As recruitment took place in a public hospital setting, this study does not include patients that were diagnosed but not retained in care or those that receive care entirely in private facilities. During the COVID-19 pandemic, the country experienced a nationwide lockdown and restrictions were imposed on in-country travel and curfews were enforced³⁸. As reported by participants, this impacted the AF pathway in terms of receiving medication, visiting the doctor and receiving INR tests; thus, potentially impacting our understanding and interpretation of the ‘usual’ AF care pathway⁶ (i.e., the pathway prior to the pandemic). However, the anticoagulation clinic functioned as usual during the lockdown period where many patients visited for care. Additionally, given this is the first study to investigate the AF care pathway in a South Asian country and one of the few to be conducted in any LMIC, the results of our study are nonetheless a critical start to understanding how and where patients with AF go for care, what areas of the pathway need improvements and what needs to be prioritized in future AF research in LMICs.

In conclusion, our findings highlight that AF diagnoses mostly occur in the A&E or inpatient department in the Northern Provence of Sri Lanka. Whilst most patients retained in care at the Jaffna Teaching Hospital (the only facility with specialist AF care)³⁶ are on anticoagulants and rate and rhythm control medication and receive routine INR tests, early diagnosis in primary care facilities must be prioritized in Sri Lanka to provide life-saving preventative medications for reducing AF-related strokes and achieve the first step within the ABC pathway. The frequency of follow-up care visits was fewer than guideline recommendations, which in part was due to the COVID-19 pandemic but could also be due to the limited access to INR tests, a barrier³⁸ likely shared by other LMICs. Learnings from the COVID-19 pandemic can be used to provide a range of delivery options closer to patients’ home for medications and INR tests to improve access to care and reduce disruptions to continuity of care during and beyond a time of crisis. Strengthening primary and community-based care would be conducive for improving the early diagnosis of and continuity of care for AF in Sri Lanka and other LMICsr³⁹; thus, could contribute to the global Sustainable development Goal 3 of reducing premature death caused by NCDs.