Pilot phase of Iraqi Registry of Cardiovascular Diseases in Women: Assessing the Feasibility of Large Data Registry in Absence of Funding

ABSTRACT IMAGE

INTRODUCTION

Despite that cardiovascular disease (CVD) is the main cause of death in women worldwide^[1] and that the existent evidence that women with CVD differs from men with same diseases from many views including pathophysiological to therapeutic, Sex differentiated approach in cardiovascular (CV) research are limited despite being crucial to improve CV care and outcomes.

There is a significant decline in cardiovascular mortality in women in high-income countries, yet there is no such decline in CVD mortality in lower-income countries.^[2] Furthermore, women are under-represented in research, trials, and even registries which limit personalized approaches to women with CVD. There is an unmet need for registries focused on sex differences in CVD, as the first step toward trials, guidelines, and protocols with a focus on sex-based differences in CVD. To the best of our knowledge, there has been no prior registry focusing exclusively on CVD in women with sex-focused research questions and methodology thus far. Accordingly, this real-world registry was designed.

MATERIALS AND METHODS

RESULTS

n = 150, mean age = 60 years, 89.3% of patients reside in urban areas. Women were mostly married (67.8%) or widowed (25.5%). They were illiterate (47.3%) or having primary education (34.7%). 60% of women’s family total income was <500 USD. Distribution of patients according to registry arms is ischemic heart disease (IHD) (n =77), acute coronary syndromes (n = 22), HF (n = 24), arrhythmias (n = 21), and VHD (n = 25), with overlap of these diagnoses in some patients [Figure 1]. The most common cardiac risk factor is hypertension while menopause and gestational hypertension are the most common sex-specific risk factors [Figure 2]. In-hospital echocardiography was done in 26%. In-hospital HF was reported in 20% of patients. Aspirin, P2Y12 inhibitors, heparin, and statin were used in 85.8%, 60.4%, 35.4%, and 87.9%, respectively. B-blockers, ACEI/ARBs, and MRA were used in 71.1%, 62.8%, and 7.2%, respectively. Dietary instructions as indicated on discharge were done properly in 96.6%, while smoking cessation counseling and referral for cardiac rehabilitation were not done properly in daily practice [Figure 3]. 78% of our pilot population was reachable at 1-month follow-up [Figure 4].

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Figure 1:

Iraqi Registry of Cardiovascular Diseases in Women (IROCW) pilot phase flow chart. (ACS: Acute coronary syndromes, IHD: Ischemic heart disease, HF: Heart failure, VHD: Valvular heart diseases, GDMT: Guideline-directed medical therapy, MI: Myocardial infarction). The second phase of IROCW includes 1-month and 12-month follow-up data, detailed analysis of each arm regarding demographic characteristics and real-world management of the study population will be reported.

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Figure 2:

Demographic features of the Iraqi Registry of Cardiovascular Diseases in women population. The data of this figure are presented as percentages.

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Figure 3:

Patients’ education at discharge. The data of this figure are presented as percentages.

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Figure 4:

One-month outcomes at follow-up. The data of this figure are presented as the number of patients.

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DISCUSSION

The IROCW project originates from the fact that (To Take a Stand against Heart Disease in Women We Should Know Better Our Enemy). Up to our knowledge, this is the first women-focused registry in the cardiovascular field, and this registry will recruit women with IHD, VHD, arrhythmia, and HF. This pilot phase was initiated and undertaken in 7 weeks to assess the feasibility of conducting large-scale registries in developing countries despite lack of funding. It was planned that Sudan would be included in the second phase of the registry;^[3] unfortunately, the war in Sudan deprived the volunteering cardiologists there of recruiting the patients. Investigators from other countries such as Turkey, Saudi Arabia, Bangladesh, and India were invited and they were supposed to participate but lack of funding withheld those investigators from participation (due to the absence of secured electronic patient data form). Accordingly, the principal investigator and IROCW team in Iraq decided to continue recruiting patients from Iraq using paper data forms and Google Forms. The results from this pilot phase are only descriptive of the main data, as this paper only portrays the clinical profile and main management lines of included patients. Detailed therapy and interventions of the larger cohort will be presented in the results of the second phase of this registry to answer the main research questions of IROCW.

It is crucial to highlight that the demographic features, risk factors, management, and outcomes should be specified for each arm of the IROCW registry (IHD, VHD, HF, and arrhythmias), which will be explored in the final results of IROCW; yet, this was not described here in details as the main objective of this snapshot pilot phase is to ensure the feasibility of patients data collection, data entry, and follow-up feasibility by investigators to proceed with the second phase of the IROCW project (which is ongoing now).

Hypertension and diabetes are very common cardiovascular risk factors in our cohort, this highlights the importance of primary preventive programs in Iraq, which unfortunately are not established yet. If such programs are structured in Iraq, this will reduce the CVD risk in women. Establishing women’s heart clinics that focus on both primary and secondary cardiovascular preventive measures will be an important part of such programs. In Iraq, like many other Middle Eastern countries, women can be deprived of proper cardiac care if not implemented exclusively by female physicians (due to cultural and custom causes),^[4] women heart clinics including multidisciplinary teams consisting of both men and women can bridge this gap in the cardiovascular care of Iraqi women. Interestingly, 7.5% of the IROCW cohort reported being a carer of a child or family member with disability and/or chronic disabling comorbidity, and this highlights the crucial role of social support for those women to improve their wellness and cardiac health.

This study highlights an important yet overlooked practice gap in managing women with CVD, which is patient education at discharge regarding diet, smoking cessation, and importantly, cardiac rehabilitation. Despite contemporary global cardiovascular guideline recommendations of addressing these measures to improve patients’ prognosis,^[5,6] developing countries are still lacking proper patients’ education programs.^[7,8] If the second phase is achieved, the IROCW project will provide data regarding current practice in Iraq, this will inform decision-makers and stakeholders of real-world adherence to guidelines and protocols and can help in streamlining education and preventive programs at the point of care of women with CVD.

One month follow-up was obtained from 78% of patients, and missing follow-up data were mainly due to the lack of reachability to the patients as reported by IROCW investigators. Accordingly, the Google Form of the next phase will include collecting two patients’ phone numbers including one of a related family member (after taking consent from the patient and the family member) to enhance the reachability of patients. It is noteworthy that in Iraq, many women, especially the older population, are digitally illiterate with limited use of their self-phones (if ever had), so having the contact information of a family member with more use of electronic devices will help in bridging this gap in patients’ communication.

IROCW is an innovative project on many levels: First, it is not only the first project globally that highlights sex-focused research questions in diverse CVD but also it is the first project that will collect data about cardiac female patients from the Middle Eastern ancestry. CVD in women in developing countries including countries from Middle East and North Africa (MENA) region can vary from those in other countries. The health illiteracy, poor socioeconomic status, lack of education opportunities, cultural factors, and barriers to proper healthcare access by women in these countries, notwithstanding that many of these countries are areas of political conflicts and/or wars which all can negatively impact the healthcare infrastructure. Moreover, certain CVD like rheumatic heart disease is of the highest prevalence in these countries, yet, limited data are available from most of these countries regarding epidemiological distribution, morbidity, and mortality due to CVD. This registry can help in bridging the knowledge gaps of such data from Iraq taking into consideration many geographical, social, economic, and cultural variables that give us the key clues on CVD in the Middle East.

Second, IROCW invested for the first time in Iraq, the young talents in research, so training and education of volunteering cardiology fellows, junior doctors, and medical students were initiated. Those talents sought mentorship and research training by being recruited into this program with data collection being their main contribution. Feedback and communication among all IROCW co-investigators during the pilot phase helped in introducing amendments to the Google Form to avoid any misinterpretation or missing data in the second phase of the project. Iraq, like many other low-middle income countries (LMIC), lacks a dedicated research workforce and collaborative research groups,^[9] and this approach in harnessing young talents in research with proper education and mentorship opportunities can provide a sustainable solution to form future research task forces in Iraq.

Third, IROCW project leaders invited many young female doctors and fellows from different geographic backgrounds to include them as co-investigators to enhance the inclusion and diversity of the research workforce, a forward step that was supported by the Iraqi Council of Cardiology after observing under-representation of women in cardiovascular research and cardiology workforce in Iraq.^[4,10]

Finally, despite the crucial role of electronic health records in research and trials establishment, especially when pragmatic research infrastructure is needed^[11] and despite the fact that IROCW project navigates the barrier of lack of electronic health records in Iraq, we think that IROCW emphasized on the importance of establishing electronic health records for the patients in Iraq and IROCW investigators are aiming now to get the required fund to establish an electronic database for patients in a single center to transfer the experience to other centers later. However, even if the IROCW investigators did not obtain the required funding for establishing an electronic database, or to fund research assistants, the sustainable initiative in recruiting human resources and the critical feedback of this pilot phase which informed the data manager of IROCW resulted in many revisions and amendments of the second phase Google Form which improved significantly the robustness and streamlining of data collection and management.

CVD in women in LMIC including countries from MENA region can vary from those in other countries.^[12] The health illiteracy, poor socioeconomic status, lack of education opportunities, and cultural factors and barriers to proper healthcare access by women in these countries, notwithstanding that many of these countries are areas of political conflicts and/or wars^[13] which all can negatively impact the healthcare infrastructure, yet no data on how these factors impacted CVD in these regions in terms of epidemiology or management. Moreover, certain CVD like rheumatic heart disease is one of the highest prevalence in Iraq;^[14] yet, limited data are available from Iraq regarding epidemiological distribution, morbidity, and mortality [Figure 5]. This registry can help in bridging the knowledge gaps of such data from Iraq taking into consideration many geographical, social, economic, and cultural variables that give us the key clues on CVD in LMIC and the Middle East.

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Figure 5:

Main challenges for addressing cardiovascular disease in women in Iraq.

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However, the IROCW project has its own limitations; first, the study included only seven centers so far representing North, Middle, and South of Iraq in general, but many cities did not participate in the registry which may limit the generalizability of the results. Second, using Google Form in data entry (that was supported by institutional backup) is not the typical platform for registry data collection (unlike other robust platforms such as RedCap or OpenClinica) but due to lack of funding, the project investigators found such a method in data collection will certainly be the most feasible alternative for paper-based data collection. The project leaders ensured robust patient data privacy and security through proper coding and entry into the Google Forms. Finally, the registry covered mainly CVD in women in arms with HF, IHD, VHD, and arrhythmias; so, other CVDs such as other myocardial, pericardial, or peripheral artery diseases were not included in the registry. Finally, there is a loss of follow-up for a sizable proportion of patients, and the investigators ensured during the second phase to have two phone numbers for the patient and close family members after taking their consent to ensure reachability during follow-up.

Unfortunately, there are no registries or national data platforms to link the IROCWs, but we hope that minimizing follow-up questions to the only necessary and having contact details of patients and carer family members can help in navigating this barrier and increase follow-up data.

CONCLUSION

Up to our knowledge, the IROCW registry is the first sex-focused methodology cardiovascular registry that will bridge the knowledge gap in clinical characteristics, diagnostic parameters, and management plans in women with CVD. It is a feasible project that will also assess the prognostic benefit of different GDMTs specifically in women, an issue that is not settled in existing literature. If a second large cohort of IROCW is achieved, it will generate data that can help in establishing a roadmap to decrease the CVD burden in women not only in Iraq but also worldwide.