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Metode Penelitian

Institutional ethics approval was obtained from the School of Medicine Research
and the Ethics Committee of the College of Health Sciences, Makerere Universit!
"e obtained informed consent for all the patients and informed assent for those
unable to give consent! #atients$ initials and stud numbers were put on the
%uestionnaires instead of full names to ensure con&dentialit!
#ersetu'uan etika institusional diperoleh dari (omite Etik #enelitian (edokteran
)akultas Ilmu (esehatan, Universitas Makerere! (ami mendapatkan informed
consent dari semua pasien! Inisial pasien dan nomor studi digunakan pada
kuesioner sebagai pengganti nama lengkap untuk men'amin kerahasiaan!
*his was a longitudinal observational stud carried out in Mulago Hospital, the
national referral hospital, and Makerere Universit teaching hospital located in
(ampala, Uganda, which receives more than +,- patients with RH. annuall! *he
target population included all patients clinicall diagnosed with rheumatic heart
disease and con&rmed b echocardiograph, as previousl described!,
#enelitian ini merupakan studi observasional longitudinal ang dilakukan di
Rumah Sakit Mulago, ang merupakan rumah sakit ru'ukan nasional, dan rumah
sakit pendidikan Universitas Makerere ang berlokasi di (ampala, Uganda, ang
menerima lebih dari +,- pasien dengan RH. setiap tahunna! #opulasi target
penelitian ini adalah semua pasien ang secara klinis didiagnosis dengan
penakit 'antung rematik dan telah dikon&rmasikan dengan ekokardiogra&,
seperti ang sebelumna di'elaskan!,
/ew and old RH. patients aged &ve to ,, ears who were eligible to continue
prophla0is for a period not less than one ear from the time of recruitment and
consented to the stud were recruited! Each patient was then given a ben1athine
penicillin prophla0is card recommending the appropriate monthl 2four3weekl4
dose of ben1athine penicillin according to the Uganda clinical guidelines, which
recommends +!5 MU for adults, -!6 MU for children 7 8- kg and 9!+ MU for those
: 8- kg!; #atients with known allerg to ben1athine penicillin were e0cluded
from the stud!
#asien ang direkrut merupakan pasien RH. baru dan lama, berusia antara lima
sampai ,, tahunangn memenuhi sarat untuk melan'utkan pro&laksis untuk
'angka waktu tidak kurang dari satu tahun dari saat perekrutan dan menetu'ui
penelitian! Setiap pasien kemudian diberikan kartu pro&laksis ben1atin penisilin
ang menun'ukkan dosis ben1atin penisilin bulanan 2empat mingguan4 ang
tepat sesuai dengan pedoman klinis Uganda, ang merekomendasikan +,5 MU
untuk orang dewasa, -,6 MU untuk anak3anak 7 8- kg dan 9,+ MU bagi mereka
: 8- kg!; #asien dengan memiliki alergi terhadap ben1athine penisilin
dikeluarkan dari penelitian!
#atients who met the inclusion criteria were consecutivel recruited over a period
of four months until a total of <, patients was reached 2)ig! 94! =n identi&cation
number or uni%ue patient number 2U#/4 was assigned to each consenting
patient! )or those who refused to consent, the reason for refusal was
documented in the stud book!
#asien ang memenuhi kriteria inklusi ang berurutan direkrut selama empat
bulan sampai total <, pasien tercapai 2>ambar! 94! /omor identi&kasi atau
nomor pasien ang unik 2U#/4 digunakan untuk masing3masing pasien ang
menetu'ui! ?agi mereka ang menolak untuk menetu'ui, alasan penolakan
didokumentasikan dalam buku penelitian!
= focused clinical assessment was done using a standardised pre3tested
%uestionnaire in which the socio3demographic data, details of phsical &ndings,
and details of &ndings on the electrocardiogram and at echocardiograph were
recorded! In addition, data regarding the following were collected@ personal
histor of hpertension, diabetes, stroke and other heart diseases! Socio3
economic factors recorded were educational level, occupation, and total income
2of parents in the case of children or students4!
Sebuah penilaian klinis terfokus dilakukan dengan menggunakan kuesioner pre3
test terstandar ang mencatat data sosio3demogra&, rincian temuan &sik, rincian
temuan pada elektrokardiogram dan echocardiograph! Selain itu, data
mengenai hal berikut 'uga dikumpulkan@ riwaat hipertensi, diabetes, stroke dan
penakit 'antung lainna! )aktor sosial ekonomi ang dicatat adalah tingkat
pendidikan, peker'aan, dan pendapatan total 2orang tua dalam kasus anak3anak
atau siswa4!
)or each patient recruited, information regarding the importance of secondar
prophla0is was provided as part of the whole information package given to the
RH. registr patients, including all their other treatment modalities! *his was
done in liaison with the primar attending clinicians! *his was to help capture the
dates and signatures of the health workers where the patient received the
ben1athine penicillin in'ections over the following si0 months! *he card had the
name of the patient, which would help track the patients$ U#/ through the stud
book!
Untuk masing3masing pasien ang direkrut, informasi mengenai pentingna
pro&laksis sekunder diberikan sebagai bagian dari paket informasi ang
diberikan kepada seluruh pasien registr RH., termasuk semua modalitas
pengobatan mereka ang lain! Hal ini dilakukan dalam hubungan dengan dokter
menghadiri primer! Ini adalah untuk membantu menangkap tanggal dan tanda
tangan dari para peker'a kesehatan di mana pasien menerima ben1atin penisilin
suntikan selama enam bulan berikutna! (artu memiliki nama pasien, ang akan
membantu melacak pasien U#/ melalui buku studi!
)or purposes of limiting loss to follow up, data concerning the following were
collected@ the patients$ phone numbers if availableAnumber of the caretaker for
childrenB phone numbers of at least two close relatives or friends, which would
be tested at the time of recording to ascertain their e0istenceB the number for
the principle investigator was written at the back of each patient$s ben1athine
penicillin card, and patients were urged to call and inform the principle
investigator if the were planning to change their phone numbers!
Untuk tu'uan membatasi mangkir, data mengenai berikut dikumpulkan@ nomor
telepon pasien 'ika tersedia A 'umlah pen'aga untuk anak3anakB nomor telepon
dari setidakna dua kerabat dekat atau teman3teman, ang akan diu'i pada saat
perekaman untuk memastikan keberadaan merekaB nomor untuk prinsip
penidik ditulis di bagian belakang kartu penisilin ben1atin setiap pasien, dan
pasien didorong untuk memanggil dan menginformasikan penidik prinsip 'ika
mereka berencana untuk mengubah nomor telepon mereka!
=fter recruitment, each patient was told to continue attending hisAher regular
clinic, as scheduled b the primar care clinician, and heAshe was to be reviewed
in the general RH. registr ever three months b other registr clinicians! )or
this particular stud, the patients were reviewed again at the end of si0 months$
follow up!
Setelah perekrutan, setiap pasien diberitahu untuk terus menghadiri A klinik
biasa na, seperti ang di'adwalkan oleh dokter perawatan primer, dan dia A dia
akan ditin'au dalam registri RH. umum setiap tiga bulan oleh dokter registri lain!
Untuk studi tertentu, pasien ditin'au kembali pada akhir enam bulan tindak
lan'ut!
=t the si03month follow3up visit, patients were contacted b phone and were
encouraged to come with their ben1athine penicillin prophla0is cards so that
data regarding their rates of adherence could be e0tracted! *hose who were
unable to travel at the si03month follow for various reasons were re%uested to
read oC the number of in'ections received at the time of the call from the card,
and this was recorded in their follow3up %uestionnaire! *hese patients were
nevertheless encouraged to take time oC and come to the clinic on an other
appropriate time for follow3up care!
#ada enam bulan kun'ungan follow3up, pasien dihubungi melalui telepon dan
didorong untuk datang dengan ben1atin penisilin pro&laksis kartu mereka
sehingga data mengenai tingkat kepatuhan mereka bisa diambil! Mereka ang
tidak mampu untuk melakukan per'alanan pada tindak enam bulan karena
berbagai alasan diminta untuk membacakan 'umlah suntikan ang diterima pada
saat panggilan dari kartu, dan ini dicatat dalam kuesioner tindak lan'ut mereka!
#asien3pasien ini tetap didorong untuk mengambil waktu istirahat dan datang ke
klinik pada waktu lain ang sesuai untuk perawatan tindak lan'ut!
)or those patients who had lost the ben1athine prophla0is card, we relied on
self3reports as to how man in'ections heAshe had received over the previous si0
months! *he proportion of these patients, together with those from whom
information was obtained over the phone was catered for during analsis! =t si0
months of follow up, a separate structured, pre3coded %uestionnaire was
administered to those patients without 9--D adherence, with the aim of
capturing the factors or reasons for missing the ben1athine prophla0is
in'ections! Measuring ben1athine penicillin in'ection deliver< was calculated as a
percentage of the number of in'ections received, divided b the number
prescribed and multiplied b 9--! Receiving less than ;-D of in'ections places an
individual at a higher risk of recurrent =R)!<
?agi pasien ang telah kehilangan kartu ben1atin pro&laksis, kami
mengandalkan laporan diri untuk berapa banak suntikan dia A dia telah
menerima lebih dari enam bulan sebelumna! #roporsi pasien ini, bersama3sama
dengan orang3orang dari siapa informasi diperoleh melalui telepon melaani
untuk selama analisis! #ada enam bulan tindak lan'ut, terstruktur, pra3kode
kuesioner terpisah diberikan kepada pasien tanpa kepatuhan 9--D, dengan
tu'uan menangkap faktor atau alasan hilang suntikan ben1atin pro&laksis!
Mengukur penisilin ben1atin deliver< in'eksi dihitung sebagai persentase dari
'umlah suntikan ang diterima, dibagi dengan 'umlah ang ditentukan dan
dikalikan dengan 9-- Menerima kurang dari ;-D dari suntikan menempatkan
individu pada risiko ang lebih tinggi dari =R)!< berulang
Analisis Statistik
.ata were entered in Epidata 8!9, backed and cleaned to prevent data loss and
then e0ported to S*=*= version 9-!-! Continuous variables were summarised in
means 2standard deviation4 and median 2inter%uartile range4! Categorical data
were summarised using fre%uenc and percentages and results are presented in
tables! *o address the &rst ob'ective, the adherence rates for RH. patients
attending Mulago Hospital were calculated as follows@
.ata dimasukkan dalam Epidata 8!9, didukung dan dibersihkan untuk mencegah
kehilangan data dan kemudian diekspor ke S*=*= versi 9-!-! Eariabel kontinu
dirangkum dalam cara 2standar deviasi4 dan median 2kisaran interkuartil4! .ata
kategori ang dirangkum dengan menggunakan frekuensi dan persentase dan
hasil disa'ikan dalam tabel! Untuk mengatasi tu'uan pertama, tingkat kepatuhan
untuk pasien RH. menghadiri Rumah Sakit Mulago dihitung sebagai berikut@
*he number of in'ections re%uired in si0 months for a patient on four3weekl
ben1athine prophla0is F si0 in'ections!
=dherence rates for individual patients was calculated as@
no of in'ections received
no of in'ections e0pected G 9--D
"e then proceeded to determine the level of adherence, the mean adherence
rate and median!
Humlah suntikan dibutuhkan dalam enam bulan untuk pasien di empat mingguan
ben1atin pro&laksis F enam suntikan!
*ingkat kepatuhan untuk setiap pasien dihitung sebagai@
'umlah suntikan ang diterima
'umlah diharapkan G 9--D
(ami kemudian melan'utkan untuk menentukan tingkat kepatuhan, tingkat
kepatuhan rata3rata dan median!
)or the second ob'ective, bivariate analsis was done with a con&dence interval
of <,D, and #earson$s chi3s%uare test was used to ascertain statistical
signi&cance! Eariables included in the bivariate analsis included age, gender,
patient$s home address, level of education, patient$s emploment status, the
/IH= class, tribe, and histor of previous use of ben1athine penicillin 2all
variables were put in two categories4! )isher$s e0act test was used where cells
had less than &ve readings! = p-value J -!-, was considered signi&cant! *o
ascertain for statistical signi&cance 2p J -!-,4 between sub'ective and ob'ective
assessment for adherence, the #earson$s chi3s%uare test was used!
Untuk tu'uan kedua, analisis bivariat dilakukan dengan tingkat kepercaaan <,D,
dan u'i chi3s%uare #earson digunakan untuk memastikan signi&kansi statistik!
Eariabel dimasukkan dalam analisis bivariat termasuk usia, 'enis kelamin, alamat
rumah pasien, tingkat pendidikan, status peker'aan pasien, kelas /IH=, suku,
dan riwaat penggunaan sebelumna ben1atin penisilin 2semua variabel ang
dimasukkan ke dalam dua kategori4! U'i )isher digunakan di mana sel3sel
memiliki kurang dari lima bacaan! Sebuah p3value J-,-, dianggap signi&kan!
Untuk memastikan untuk signi&kansi statistik 2p J-,-,4 antara penilaian
sub'ektif dan ob'ektif untuk kepatuhan, u'i chi3s%uare #earson digunakan!
Hasil Penelitian
)rom Hune +-99 to March +-9+, out of the 99+ patients screened for eligibilit, <,
rheumatic heart disease patients were recruited and followed up for a period of
si0 months to assess their adherence levels and associated factors 2)ig! 94!
Reasons for e0cluding the 9K patients included@ si0 patients with probable RH.,
four patients with congenital heart disease, four with mitral valve prolapse and
three declined to consent! Lut of these <, patients, ;+ 2;6!8D4 completed the
si03month follow3up periodB 98 298!KD4 did not complete si0 months of follow up
because 9- had died and three were lost to follow up! Lf the ;+ patients who
completed follow up, K9 2;6!6D4 were ob'ectivel assessed for adherence levels
using the ben1athine penicillin card provided at the beginning of the stud and
99 298!5D4 were sub'ectivel assessed using self3reporting! Lf the 99 patients,
si0 came to hospital at follow up but had lost their cards and &ve were followed
up over the phone!
.ari Huni +-99 hingga Maret +-9+, dari 99+ pasien ang diskrining untuk
kelaakan, <, pasien penakit 'antung rematik direkrut dan ditindaklan'uti untuk
'angka waktu enam bulan untuk menilai tingkat kepatuhan mereka dan faktor
terkait 2>ambar! 94! =lasan tidak termasuk 9K pasien ang dilibatkan@ enam
pasien dengan kemungkinan RH., empat pasien dengan penakit 'antung
bawaan, empat dengan prolaps katup mitral dan tiga menolak untuk menetu'ui!
.ari <, pasien tersebut, ;+ 2;6!8D4 menelesaikan masa tindak lan'ut enam
bulanB 98 298,KD4 tidak menelesaikan enam bulan tindak lan'ut karena 9-
tewas dan tiga hilang untuk menindaklan'uti! .ari ;+ pasien ang menelesaikan
tindak lan'ut, K9 2;6!6D4 ang obektif dinilai untuk tingkat kepatuhan
menggunakan kartu ben1atin penisilin tersedia pada awal studi dan 99 298,5D4
ang dinilai secara sub'ektif menggunakan self3pelaporan! .ari 99 pasien, enam
datang ke rumah sakit pada tindak lan'ut tapi telah kehilangan kartu mereka dan
lima ditindaklan'uti melalui telepon!
*able 9 shows the baseline characteristics of the patients! *he ma'orit was
female 2K,, K;!<D4! *he patients$ ages ranged from &ve to ,, ears, with a
mean age of +;!9 ears 2S. 9+!+4 and median +; ears! *he ma'orit of patients
were over 9; ears 2K8, K6!;D4 and ,K 26-D4 patients were townAcit residents
compared to 8; 25-D4 from rural areas! *he ma'orit 255, 56!8D4 had primar
educational level while eight 2;!5D4 were illiterate! Most of the patients were
either /IH= class II 28<, 59!9D4 or III 28+, 88!KD4! *he ma'orit 25<, ,9!6D4 were
in the ?aganda tribe!
*abel 9 menun'ukkan karakteristik dasar dari pasien! Maoritas adalah
perempuan 2K,, K;,<D4! Usia pasien berkisar antara lima sampai ,, tahun,
dengan usia rata3rata +;,9 tahun 2S. 9+,+4 dan median +; tahun! Sebagian
besar pasien lebih dari 9; tahun 2K8, K6,;D4 dan ,K 26-D4 pasien adalah warga
kota A kota dibandingkan dengan 8; 25-D4 dari daerah pedesaan! Maoritas 255,
56!8D4 memiliki tingkat pendidikan dasar sementara delapan 2;,5D4 ang buta
huruf! Sebagian besar pasien ang baik /IH= kelas II 28<, 59!9D4 atau III 28+,
88!KD4! Maoritas 25<, ,9,6D4 berada di suku ?aganda!
)ig! + shows the levels of adherence after si0 months of follow up! Lf the ;+
patients who completed the si03month follow up, 55 2,5D4 had adhered to the
monthl ben1athine penicillin prophla0is, with adherence rates M ;-DB 8;
256D4 patients were classi&ed as non3adherent to the monthl ben1athine
penicillin, with rates less than ;-D! *he mean adherence rate was K-!9+D 2S.
+<!+,4 and the median rate was ;8!8-D with a range of -N9--D! )ig! 8 shows
the number of patients across diCerent adherence levelsB +K 288D4 of the
patients had e0tremel poor adherence rates of 7 6-D!
>ambar! + menun'ukkan tingkat kepatuhan setelah enam bulan tindak lan'ut!
.ari ;+ pasien ang menelesaikan enam bulan menindaklan'uti, 55 2,5D4 telah
berpegang pada ben1atin penisilin pro&laksis bulanan, dengan tingkat kepatuhan
M ;-DB 8; 256D4 pasien digolongkan sebagai tidak patuh terhadap penisilin
ben1atin bulanan, dengan tarif kurang dari ;-D! *ingkat kepatuhan rata3rata
adalah K-,9+D 2S. +<!+,4 dan tingkat rata3rata adalah ;8,8-D dengan kisaran
-39--D! >ambar! 8 menun'ukkan 'umlah pasien di seluruh tingkat kepatuhan
ang berbedaB +K 288D4 dari pasien memiliki tingkat kepatuhan ang sangat
miskin dari 7 6-D!
Lf the ;+ patients who completed the si03month follow up, K9 2;6!6D4 presented
their cards at follow up and their adherence rates were assessed ob'ectivel b
counting the number of in'ections received over the follow3up time, compared to
the 99298!5D4 who gave a self3report of the number of in'ections received! *able
+ shows a lack of signi&cant diCerence between adherence levels as measured
among these two groups of patients!
.ari ;+ pasien ang menelesaikan enam bulan tindak lan'ut, K9 2;6!6D4
menun'ukkan kartu mereka pada tindak lan'ut dan tingkat kepatuhan mereka
dinilai secara ob'ektif dengan menghitung 'umlah suntikan ang diterima selama
masa tindak lan'ut, dibandingkan dengan 99 298,5D4 ang memberikan laporan
diri dari 'umlah suntikan ang diterima! *abel + menun'ukkan kurangna
perbedaan ang signi&kan antara tingkat kepatuhan ang diukur antara kedua
kelompok pasien!
*able 8 shows the patient factors associated with adherence to the monthl
ben1athine penicillin prophla0is! =lthough statisticall signi&cant associations
with adherence were not found, trends towards adherence were demonstrated
among patients who resided in a townAcit 2LR 9!K8B CI -!65N5!K+4 and those
with at least secondar levels of education 2LR +!+9B CI -!;8N,!<84! *here was no
diCerence in the levels of adherence between those under 9; compared with
M9; ears! *he lack of previous e0posure to ben1athine penicillin was not
associated with better adherence!
*abel 8 menun'ukkan faktor pasien terkait dengan kepatuhan terhadap
pro&laksis penisilin ben1atin bulanan! Meskipun hubungan ang signi&kan secara
statistik dengan kepatuhan tidak ditemukan, tren terhadap kepatuhan ang
ditun'ukkan antara pasien ang tinggal di kota A kota 2LR 9!K8B CI -,6535,K+4 dan
orang3orang dengan setidakna tingkat menengah pendidikan 2LR +!+9B CI -,;83
,,<8 4! *idak ada perbedaan dalam tingkat kepatuhan antara mereka ang di
bawah 9; dibandingkan dengan M9; tahun! (urangna paparan sebelumna
untuk ben1athine penisilin tidak dikaitkan dengan kepatuhan ang lebih baik!
*able 5 shows the commonest reasons b the respondents for missing a
ben1athine penicillin dose! *hese reasons included those given b patients who
had adherence levels above ;-D but not reaching 9--D! *he commonest reason
for missing a dose was the painful nature of the ben1athine penicillin in'ection,
reported b +K respondents 2+<D of all reasons given4! *his was closel followed
b lack of transport mone to the health facilit to receive the in'ection! *he
other reasons included in'ection abscesses, attendant too bus at home with
children and unable to go for the in'ection, the thought it was acceptable to
miss a few times, one patient had valvular surgical repair and was advised b the
local health practitioner that there was no need for an more in'ections!
*abel 5 menun'ukkan alasan terumum ang dinatakan oleh responden untuk
melewatkan suntukan penisilin ben1atin! =lasan3alasan ini termasuk alasan ang
diberikan oleh pasien ang memiliki tingkat kepatuhan di atas ;-D tetapi tidak
mencapai 9--D! =lasan paling umum untuk melewatkan suntikan adalah adana
rasa menakitkan pada in'eksi penisilin ben1atin, ang dilaporkan oleh +K
responden 2+<D dari semua alasan ang diberikan4! =lasan ang kedua adalah
kekurangan uang transportasi ke fasilitas kesehatan untuk menerima suntikan!
=lasan ang lainna termasuk abses pada tempat in'eksi, dan terlalu sibuk di
rumah dengan anak3anak sehingga tidak mampu pergi untuk in'eksi, mereka
pikir tidak akan berpengaruh apa3apa, apabila mereka melewatkan suntikan
beberapa kali, satu pasien ang mengalami operasi perbaikan katup disarankan
oleh praktisi kesehatan setempat bahwa sudah tidak perlu mendapatkan
suntikan lagi!

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