CARDIOVASCULAR JOURNAL OF AFRICA • Volume 25, No 4, July/August 2014
160
AFRICA
Study rationale and objectives
A previous study, ENDORSE, was conducted in 32 countries
worldwide, except in sub-Saharan Africa. The results of this
study confirmed the high prevalence of patients at risk for
VTE; about 52%, among medical and surgical hospital patients.
Despite the high prevalence of VTE risk factors, only 58.5%
of surgical patients and 39.5% of medical patients received
thromboprophylaxis.
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ENDORSE-Africa aimed to collect
specific African data on thromboprophylaxis and to structure
the doctors’ and other healthcare stakeholders’ awareness on the
challenges of VTE prophylaxis.
The primary objectives of this survey were (1) to identify
patients at risk for VTE among all patients hospitalised in
representative hospitals throughout some African countries, and
(2) to determine the proportion of at-risk hospital patients who
receive effective types of VTE prophylaxis.
The secondary objectives were: (1) to define the overall rate of
appropriate prophylaxis in medical versus surgical populations,
(2) to define the global rate of patients at risk by type of acute
illness (medical and/or surgical), (3) to describe the factors
driving the prophylaxis decisions; (4) to carry out all preceding
analyses in each country.
Methods
The study was a multinational, observational, cross-sectional
survey on prevalence of VTE risk in hospital patients. The survey
aimed at collecting information on the prevalence of VTE risk in
hospital patients in selected sub-Saharan African countries. No
intervention or modification of standard care was carried out.
Subjects were evaluated during a single audit visit. However,
the information regarding VTE risk, prophylaxis and bleeding
risk were recorded retrospectively to reflect the conditions
present on admission or that developed within the first 14 days
following hospital admission, regardless of the overall length of
stay of a given patient. The focus on the first 14 days following
hospital admission reflected the evidence base for the survey,
that is, randomised clinical trials of VTE prophylaxis in a wide
variety of at-risk hospitalised patients.
In published trials, patients at risk were identified and VTE
prophylaxis was begun at or soon after hospital admission. This
survey therefore focused on the first 14 days following hospital
admission for an acute medical illness or major surgery. No
follow-up data were collected.
In the medical group, patients 40 years of age or older who
were admitted for treatment of a serious medical illness and/
or were admitted for a major traumatic event that required no
major operation (including closed head injury) were included
in the study. In the surgical group, to be included in the surgical
arm of the study, patients had to be 18 years or older and to
have undergone a major surgical operation requiring general or
epidural anesthesia lasting at least 45 minutes.
Patients were excluded from the study on one criterion;
exclusion by type of illness. Patients admitted to or cared for
in a hospital ward, floor or care unit dedicated to psychiatric,
paediatric, palliative care, maternity, ear, nose and throat, burns,
dermatological/ophthalmological, alcohol/drug treatment were
excluded from the survey. Patients in bed on the day of this
survey in eligible wards (clinical units) were reviewed individually
for eligibility to participate in this survey.
This survey was conducted in accordance with the principles
laid down by the 18th World Medical Assembly (Helsinki,
1964) and all subsequent amendments and guidelines for good
epidemiology practice. In addition, each participating country
obtained all necessary regulatory and ethics approvals in
accordance with local regulations.
Data collection
The survey was conducted in hospitals in one or two big cities
of each participating country. The participating hospitals were
selected from a complete list of all hospitals in each city.
Hospitals dedicated exclusively to psychiatric care, care of
children, rehabilitation/hospice care, or scheduled for only major
operations were excluded. Hospitals with more than 50 beds
that admit patients for treatment of acute medical illnesses or
exacerbation of chronic disease, and schedule routine major
surgical procedures were included in this survey. Data were
collected using the following tools and methods.
A hospital information questionnaire was completed by the
lead investigator at each participating hospital. This was used to
collect the following information on each participating hospital:
hospital address, type of hospital (general/speciality), number
of hospital beds, number of ICU beds, services available at
the hospital (e.g. orthopedic surgery, ICU, emergency room),
name and contact information of the ENDORSE investigator
at the hospital, types of VTE prophylaxis that are available for
use (formulary coverage), annual number of patient discharges,
hospital-wide standards for VTE prophylaxis, types of patient
wards (care units) that were not eligible for inclusion in
ENDORSE, and total number of patients in units not eligible
for this audit.
A ward questionnaire was completed by the investigator or
his/her co-workers on the day of the ENDORSE audit, at each
participating hospital. The ward information questionnaire was
used to collect the following information on each participating
hospital ward: total number of patient beds in the ward, ward
standards for VTE prophylaxis, number of beds occupied on the
day of the ENDORSE audit, and for ward patients who were not
eligible for enrollment in ENDORSE, the reason for ineligibility.
A two-page patient case report form (CRF), was completed
for each patient who was hospitalised in a qualified ward
and who was otherwise eligible for enrollment. For eligible
patients whose medical charts were available, the following
information was collected and entered in the CRF: demographic
information (age, gender), weight and height, type of major
surgical procedure performed or major medical illness present
on admission or during the first 14 days of hospitalisation,
day of admission (as day 1 up to day 14) on which the surgical
procedure/major medical illness was recorded in the chart
(diagnosed), additional risk factors for VTE present during the
first 14 days of hospitalisation, risk factors for bleeding present
during the first 14 days of hospitalisation, day of hospitalisation
on which the VTE risk factor/bleeding risk factor was first noted
in the chart (first to 14th), type of VTE prophylaxis used and
the day of hospitalisation on which it was initiated /terminated,
presence/absence of the therapeutic anticoagulation, and the
day of hospitalisation on which it was initiated/terminated.
The two-page case report form was collected and sent to data
management for analysis.
