Nama anggota:

1400023171_Nafiah Ema Suryani_FKKB

1400023173_Nadya Amalia_FKKB
1400023174_Wahyu Tirta Sari_FKKB

Judul: Randomized controlled trials of malaria intervention trials Yes Cant tell No
in Africa, 1948 to 2007: a descriptive analysis
1. Did the trial address a clearly focused issue? - -
2. Was the assignment of patients to treatments randomised? - -
3. Were all of the patients who entered the trial properly accounted for at its
- -
conclusion?
4. Were patients, health workers and study personnel blind to treatment? - -
5. Were the groups similar at the start of the trial? - -
6. Aside from the experimental intervention, were the groups treated equally? -
7. How large was the treatment effect? - -
8. How precise was the estimate of the treatment effect? - -
9. Can the results be applied in your context? - -
10. Were all clinically important outcomes considered? - -
11. Are the benefits worth the harms and costs? - -
A Are the results of the trial valid? YES NO CANT
TELL
1. Did the trial address a clearly focused issue?

KET : Fifty-three of the 92 included trials evaluated a treatment intervention for malaria and 38 YES
trials reported on malaria preventive measures; one trial reported both prevention and
treatment.
2. Was the assignment of patients to treatments randomised?

KET : Assessment of the methodological quality of RCTs was based on four items: allocation
generation, allocation concealment, blinding and loss to follow up. RCTs from the random YES
sample published between 1997 and 2007 were considered for this analysis (n = 60)
3. Were all of the patients who entered the trial properly accounted for at its conclusion?

KET :Most trials were of medium size (100-500 participants), individually randomized and YES
based in a single centre.
4. Were patients, health workers and study personnel blind to treatment?

KET :The quality of reporting was not consistent among its different domains: loss to follow CANT
up was accounted for in the majority of RCTs, but allocation concealment was mostly unclear, TELL
and generation of allocation sequence and blinding were also not clearly reported or altogether /UNCLEAR
not mentioned in a large proportion of malaria RCTs.
5. Were the groups similar at the start of the trial?
CANT
Sebagian besar percobaan menyelidiki pengobatan obat pada anak-anak dengan malaria TELL
tanpa komplikasi. Beberapa percobaan melaporkan tentang pengobatan malaria berat atau /UNCLEAR
intervensi wanita hamil.
6. Aside from the experimental intervention, were the groups treated equally?
CANT
TELL
/UNCLEAR
 7. How large was the treatment effect?

Fifty-three of the 92 included trials evaluated a treat-ment intervention for malaria and 38
trials reported on malaria preventive measures.
For the 53 trials of malaria treatment, 44 reported on treatment of acute uncomplicated
malaria, seven reported on severe malaria, one on asymptomatic malaria and one report was YES
unclear. All Of the 38 trials of malaria prevention, 10 reported on drug interventions and 10
on the use of bed nets or other physical barriers, six reported on nutritional sup-plements, six
on vaccines, five on combinations of nutri-tional supplements and drugs and one trial
reported on a combination of bed nets and drug prophylaxis.

8. How precise was the estimate of the treatment effect?

The majority of RCTs reported on drug treatment of children suffering from uncomplicated malaria, in
agree-ment with the high burden of malaria in the under-fives and with the development and testing YES
of novel drug regimens such as artemisinin-based combination therapy (ACT).
Few RCTs investigated treatment of severe malaria or interventions in pregnant women. Clinical
studies in severe malaria are considered difficult to plan and execute.

9. Can the results be applied in your context?

(or to the local population?)

HINT: Consider whether

Do you think that the patients covered by the trial are similar enough to the patients to whom you will apply this?, if not how to they differ?
Dapatkah hasilnya diterapkan dalam konteks Anda?
Pertimbangkan apakah menurut Anda apakah pasien dicakup oleh percobaan cukup mirip dengan pasien yang Anda inginkan menerapkan ini ?, jika tidak bagaimana mereka
berbeda?

The presence of locally based researchers has been

The presence
found of locally
to positively affectbased researchers
the local has been
development found to positively affect the local development of skills and training [7,12] and is in general correlated to research
of skills
relevant
and to the
training particular
[7,12] and is country.
in general correlated to
research relevant to the particular country.

10. Were all clinically important outcomes considered?

HINT: Consider
Is there other information you would like to have seen?
If not, does this affect the decision?
Apakah semua hasil penting secara klinis dipertimbangkan?
PETUNJUK: Pertimbangkan
Apakah ada informasi lain yang ingin Anda lihat?
. Jika tidak, apakah ini mempengaruhi keputusan?

Ethics, informed consent

Approximately three-quarters of RCTs reported on approval by an ethics committee and a similar percentage included information on participants consent
to the procedure. Reporting of approval by an ethics committee markedly improved over time and the vast majority of RCTs run in the last decade had
received local or international ethics approval. This is an encouraging result overall, and several trial reports also provided a detailed description of the
consent procedure; however, 38 reports stated consent had been obtained, but did not provide any details. Similarly, in a recent systematic review of
registered trials of malaria, tuberculosis and HIV/AIDS [28], informed consent was reported in 58% of trials.

The majority of RCTs reported on drug treatment of children suffering from uncomplicated malaria, in agreement with the high burden of malaria in the under-
fives[13] and with the development and testing of novel drug regimens such as artemisinin-based combination therapy (ACT). ACT was included in World Health
Organization malaria guidelines in 2006 [14,15], prompting many African countries to run clinical trials in order to assess the best drug combination to be
included in national policies. Few RCTs investigated treatment of severe malaria or interventions in pregnant women. The scarcity of clinical
trials for severe malaria was noted in a previous study [16], showing that fewer than 10,000 patients have been included in RCTs despite approximately ten
million cases of severe malaria occurring annually. Clinical studies in severe malaria are considered difficult to plan and execute [17], and are often characterized
by slow enrolment, requiring many sites and several years for completion. Also, after the successful introduction of ACT regimens, patients with severe malaria
may simply not be found any more in some countries, as reported in Vietnam [18].
11. Are the benefits worth the harms and costs?
HINT: Consider
Even if this is not addressed by the trial, what do you think?
Apakah manfaatnya menguntungkan kerugian dan biaya?
PETUNJUK: Pertimbangkan
Bahkan jika ini tidak ditangani oleh percobaan bagaimana menurut Anda?

Information about trial funding and sponsorship was

not included, or was poorly reported, in many published
trials, and for this reason it has not been included in the
final analysis. It has previously been shown that almost
all African HIV/AIDS trials are led and funded by international
organizations [10] and if the same is true of
malaria trials, this can explain why many authors of trial
reports are based outside Africa. The nature of funding This information is needed to plan and implement future malaria
agencies is also likely to influence priorities for trials clinical trials, to suggest research areas that may have been overlooked,
and research receiving funding from private industry, and to point to methodological aspects that need to be addressed when
for instance, was found to be associated with reduced planning future activities.
emphasis on diseases relevant to Africa [7].

Information about trial funding and sponsorship was

not included, or was poorly reported, in many published
trials, and for this reason it has not been included in the
final analysis. It has previously been shown that almost
all African HIV/AIDS trials are led and funded by international
organizations [10] and if the same is true of
malaria trials, this can explain why many authors of trial
reports are based outside Africa. The nature of funding
agencies is also likely to influence priorities for trials
and research receiving funding from private industry,
for instance, was found to be associated with reduced
emphasis on diseases relevant to Africa [7].