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CARDIOVASCULAR JOURNAL OF AFRICA • Volume 29, No 2, March/April 2018
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research has a positive effect on patient management. Clinical
practices established during REMEDY, such as closer follow
up, increased provision of family planning counselling and the
promulgation of independent RHD clinics have continued since
original publication of the study. For example, one participant
remarked, ‘Before REMEDY we didn’t realise what proportion
of patients stopped coming for follow up. Some of them were
not regular in attending their clinic and nobody really noticed,
but because we had to keep track of them during REMEDY, it
improved their engagement with the healthcare system and their
follow-up attendance’.
Involvement in REMEDY also resulted in the acquisition of
new research skills by the study team members and improved
sites’ ability to conduct RHD research, as demonstrated by
the increase in RHD projects post-REMEDY. Furthermore,
publication of the results of REMEDY
3,4,11
increased public
awareness of RHD and advocacy for its prevention among
higher medical and political authorities, such as local and
national ministries of health.
Involvement in a project with such widespread impact boosted
morale among staff at sites with high volumes of RHD patients.
For example, one researcher commented, ‘When you’re faced
with tides and tides of patients and you’re on your own, it can
feel quite disheartening. REMEDY encouraged participants, it
gave job satisfaction and it improved motivation in general’.
Several factors impeded the study’s progress. Unavoidable
situations such as informal address systems and political unrest
in several countries where REMEDY sites were based resulted
in loss to follow up of REMEDY patients. Furthermore, the
majority of survey respondents (22/30) had small on-site teams
(0–10 individuals) to assist them in conducting the REMEDY
study. Those with limited on-site support remarked in the
telephone interview that they found the study taxing on their time
and resources and that, as a result, they were unable to perform
critical tasks such as timely application for ethical approval.
On-site support for GCP training courses was also lacking
for 18/30 survey respondents. Given the positive feedback and
advocacy from both survey and telephone interview respondents
for more GCP training, site initiation and monitoring visits,
future related projects should dedicate time and funding to
on-site visits and training in order to educate investigators about
the project and to assess each site’s resources individually.
Our study has several implications for future research and
clinical practice. First, the rise in rheumatic and congenital heart
disease projects and ensuing collaboration among cardiologists
as a result of REMEDY has greatly increased global awareness
of RHD. This growing research network is a major advocacy tool
for the disease and demonstrates the importance of continuing
efforts to conduct and facilitate RHD research.
Second, our results indicate that observational registries such
as REMEDY have significant value. Not only did the publication
of the findings of REMEDY increase public awareness of
RHD but it also directly improved clinicians’ and patients’
understanding of the disease. In resource-limited countries, the
initiation of local and national registries is the cornerstone of
the RHD prevention and control programmes recommended by
the World Health Organisation and the World Heart Federation.
Finally, the majority of survey and telephone interview
respondents used their experiences during REMEDY to propose
suggestions for future related studies. Their ideas provide a
valuable resource to researchers working on similar projects
and demonstrate the importance of involving clinicians who
are active in the field (and not just those in principal academic
centres) in programmes of clinical research.
Our study highlights these important implications but is of
course limited by the subjective impression from investigators and
research staff, rather than stringent monitoring and evaluation
processes running alongside the original study. We suggest
therefore that these are incorporated into future studies in
LMICs to demonstrate the additional benefits (or disadvantages)
of research to communities, research personnel and patients.
Conclusions
Researchers in the field should draw confidence from our findings
that RHD research improves overall patient management and
advocacy for the disease. The important lessons learnt were
strategies employed by the REMEDY investigators to reduce loss
to follow up, the benefits of early application for ethics approval,
and the importance of on-site initiation and monitoring during
multi-centre projects.
The authors acknowledge the work of the original REMEDY investiga-
tors*, especially the key investigators (Salim Yusuf, Koon Teo, Ganesan
Karthikeyan, Bongani Mayosi), and are grateful to all those who responded
to the questionnaire and participated in the telephonic interviews.
*Liesl Zühlke, Ganesan Karthikeyan, Mark E Engel, Sumathy Rangarajan,
Pam Mackie, Blanche Cupido, Katya Mauff, Shofiqul Islam, Rezeen Daniels,
Veronica Francis, Stephen Ogendo, Bernard Gitura, Charles Mondo, Emmy
Okello, Peter Lwabi, Mohammed M Al-Kebsi, Christopher Hugo-Hamman,
Sahar S Sheta, Abraham Haileamlak, Wandimu Daniel, Dejuma Yadeta
Goshu, Senbeta G Abdissa, Araya G Desta, Bekele A Shasho, Dufera M
Begna, Ahmed ElSayed, Ahmed S Ibrahim, John Musuku, Fidelia Bode-
Thomas, Christopher C Yilgwan, Ganiyu A Amusa, Olukemi Ige, Basil
Okeahialam, Christopher Sutton, Rajeev Misra, Azza Abul Fadl, Neil
Kennedy, Albertino Damasceno, Mahmoud Sani, Okechukwu S Ogah, Taiwo
Olunuga, Huda HM Elhassan, Ana Olga Mocumbi, Abiodun M Adeoye,
Phindile Mntla, Dike Ojji, Joseph Mucumbitsi, Koon Teo, Salim Yusuf,
Bongani M Mayosi.
In addition, we thank Gabriel Zühlke for the creation of Fig. 3, and acknowl-
edge the assistance of the Children’s Heart Disease Research Unit at the Red
Cross War Memorial Children’s Hospital in conducting this study.
References
1.
Global Burden of Disease 2015 Mortality and Causes of Death collabo-
rators. Global, regional, and national life expectancy, all-cause mortal-
ity, and cause-specific mortality for 249 causes of death, 1980–2015: a
systematic analysis for the Global Burden of Disease Study 2015.
Lancet
2016;
388
(10053): 1459–1544.
2.
Zühlke LJ, Karthikeyan G, Engel M, Cupido B, Joachim A, Daniels R,
et al.
The Rheumatic Heart Disease Global Registry (REMEDY) study
– Preliminary report.
Circulation
2012;
125
: e723.
(Oral presentation:
World Congress of Cardiology, Dubai, UAE. 18–21 April 2012 ).
3.
Zuhlke L, Engel ME, Karthikeyan G, Rangarajan S, Mackie P, Cupido
B,
et al
. Characteristics, complications, and gaps in evidence-based
interventions in rheumatic heart disease: the Global Rheumatic Heart
Disease Registry (the REMEDY study).
Eur Heart J
2015;
36
(18):