MAKALAH EVIDENCE BASED MEDICINE

RANDOMIZED CONTROLLED TRIAL

FARMASI IV C

Diususun Oleh :

Melinda Fila Betha

11194761920308

PROGRAM STUDI FARMASI

FAKULTAS KESEHATAN UNIVERSITAS SARI MULIA

BANJARMASIN

2020
 KATA PENGANTAR

Puji dan syukur kami panjatkan kehadirat Allah SWT, yang masih memberikan
rahmat, taufik, dan hidayahnya sehingga penulis dapat menyusun makalah Evidence
Based Medicine yang berjudul“Randomized Controlled Trial”
Shalawat berantaikan salam tidak lupa pula saya haturkan kepada junjungan kita
Nabi Muhamad SAW yang telah membawa kita dari zaman kegelapan menuju zaman
yang terang bederang yang diterangi oleh iman, islam, dan ihsan.
Selanjutnya penulis mengucapkan terima kasih kepada Dosen Pengampu yang
telah memberikan ilmu, arahan dan bimbingannya dalam menyelesaikan makalah ini.
Penulis menyadari dalam makalah ini masih banyak terdapat kekurangan, baik
dalam penulisan maupun penyajiannya, maka sekiranya saya sangat mengharapkan
kritik dan saran yang bersifat membangun agar kedepannya lebih baik. Semoga makalah
ini bermanfaat bagi saya sendiri khususnya dan pembaca umumnya.

Banjarmasin 12 April 2020

Penulis
 DAFTAR ISI

BAB I PENDAHULUAN.......................................................................................1
1.1 Latar Belakang..........................................................................................1
1.2 Rumusan Masalah.....................................................................................1
1.3 Tujuan........................................................................................................1
BAB II TINJAUAN PUSTAKA............................................................................2
2.1 Pengertian RCT (Randomised Controlled Trial).......................................2
2.2 Jenis dan Karakteristik RCT......................................................................3
2.3 Faktor yang Mempengaruhi RCT..............................................................3
2.4 Kelemahan dan kelebihan RCT.................................................................4
2.5 Perhitungan sampel RCT..........................................................................4
2.6 Pengolahan Statistik RCT.........................................................................5
BAB III PENUTUP................................................................................................9
3.1 Kesimpulan.....................................................................................................9
DAFTAR PUSTAKA...........................................................................................10

i
 BAB I
PENDAHULUAN
1.1 Latar Belakang
EBM sangat diperlukan dalam menyelesaikan atau menyusun setiap
langkah penelitian yang mengandalkan sebuah bukti nyata, agar proses tersebut
mudah diciptakan lah istilah metode penelitian, bebrapa ahli menyebutkan bahwa
metode penelitian ialah cara utama yang digunakan peneliti untuk mencapai tujuan
& menentukan jawaban atas masalah yang diajukan (Nasir, 2008), ahli lain
mengatakan metode penelitian adalah suatu kegiatan ilmiah yang dilakukan dengan
teknik yg teliti & sistematik (Winarno, 1982).
Metode penelitian yang dikembangkan kemudian berkembang menjadi
beberapa cabang yang salah satunya yakni penelitian berdasarkan Randomized
Controlled Trials (RCT). Tipe penelitian ini memiliki konsep dimana subyek suatu
populasi dari suatu kelompok dimasukkan secara acak ke dalam kelompok yang
akan dijadikan penelitian. Metode penelitian Randomized Controlled Trials (RCT)
sering digunakan terutama untuk sampel yang jumlahnya banyak dan diperlukan
kemampuan menganalisis suatu populasi, RCT sendiri terbagi menjadi beberapa
jenis metode penelitian, sehingga dapat memudahkan para peneliti karena metode
penelitian ini termasuk fleksibel dan variatif. Penulis berharap dengan adanya
makalah ini metode RCT ini dapat dijadikan patokan dalam suatu penelitian
komunitas.

1.2 Rumusan Masalah

1. Apa yang dimaksud dengan RCT?
2. Apa jenis dan karakteristik RCT?
3. Apa saja faktor yang mempengaruhi RCT?
4. Apa kelebihan dan kelemahan studi RCT?
5. Bagaimana perhitungan sampel RCT?
6. Bagaimana menganalisis data statistik pada metode RCT?

1.3 Tujuan
1. Mengetahui apa itu RCT.
2. Mengetahui jenis dan karakteristik RCT.
3. Mampu menangani faktor-faktor yang memperngaruhi RCT.
4. Mengetahui kelebihan dan kelemahan studi RCT.
5. Mengetahui cara perhitungan sampel RCT
6. Dapat menganalisis data statistik pada metode RCT dalam penelitian.

1
 BAB II
TINJAUAN PUSTAKA

2.1 Pengertian RTC (Randomized Controlled Trial)

RCT (Randomized Controlled Trial) adalah eksperimen epidemiologis
dimana subjek dalam suatu populasi dialokasikan secara acak kedalam kelompok,
biasanya disebut kelompok studi dan control untuk menerima dan tidak menerima
prosedur, manuver, atau intervensi eksperimental preventif atau terapi (John
M.Last,2001).
Randomized Controlled Clinical Trials adalah suatu jenis penelitian
epidemiologi dimana subyek dari suatu populasi dikelompokkan secara acak ke
dalam grup yang biasa disebut dengan kelompok studi dan kelompok kontrol,
untuk menerima dan tidak menerima suatu tindakan preventif, terapeutik, manuver
dan intervensi. Jenis penelitian ini biasanya digunakan untuk mengetahui
efektivitas suatu obat. (Syeba Dinda, 2012).

RCT dapat dianalisis dengan analisis intentionto-treat (ITT; subyek

dianalisis dalam kelompok yang diacak), per protokol (hanya peserta yang berada
pada grup asalnya dan menyelesaikan pengobatan yang dapat dianalisis), ataupun
variasi dengan kondisi lain, penggunaan ITT dapat membuat hasil tidak bias.
Semua metode variasi RCT seharusnya akan menunjukkan hasil/tujuan utama yang
ingin dicapai, kemudian harus didaftarkan dengan database uji klinis dan harus
memiliki persetujuan etis yang sesuai. RCT dapat memiliki kelemahan, termasuk
biaya tinggi dalam hal waktu dan uang, masalah dengan generalisabilty (peserta
yang sukarela berpartisipasi mungkin tidak mewakili populasi yang diteliti) dan
berhenti berpartisipasi secara mendadak. (Joseph J, 2018).
Dalam merancang RCT, ada beberapa hal penting yang harus diingat agar
penelitian yang diinginkan dapat tercapai hal penting tersebut antara lain :
a. Penempatan yang secara acak pada grup intervensi (Bonnie s,1998)
b. Pasien dan pengujicoba harus dalam kondisi tidak tau bahwa mereka akan
diberikan pengobatan jenis apa, hingga metode penelitian ini selesai (Bonnie
s,1998).
c. Semua yang berada pada grup intervensi di berikan pengobatan yang sama
kecuali berkenaan dalam pengobatan untuk eksperimen (Bonnie s,1998).
d. Pasien secara normal dianalisis pada grupnya dimana mereka ditempatkan,
terlepas dari apakah mereka intervensi atau tidak (Bonnie s,1998).
e. Analisi difokuskan untuk memperkirakan jumlah perbedaann antara hasil
sebelumnya dengan grup intervensi (Bonnie s,1998).

2
2.2 Jenis dan Karakteristik RCT
RCT(Randomized Controlled Trial) mempunyai beberapa jenis yaitu
sebagai berikut:
a) Open trial: peneliti dan subyek penelitian mengetahui obat apa yang
diberikan.
b) Single mask (single blind): salah satu pihak tidak mengetahui obat apa yang
diberikan, bisa saja peneliti atau subyek penelitian.
c) Double mask (double blind): kedua pihak ( peneliti dan subyek penelitian)
tidak mengetahui pengobatan yang diberikan, demi menghindari terjadinya
berbagai bias.
d) Triple mask (triple blind): peneliti, subyek penelitian, dan penilai tidak
mengetahui obat apa yang diberikan.
Adapun karakteristik dari RCT tersendiri untuk membedakan dengan studi
penelitian yang lain yaitu:
a) Adanya randomisasi
b) Memberikan tingkat perlakuan yang berbeda pada subyek penelitian
c) Adanya blinding (teknik untuk membuat subyek dan atau pengamat dan atau
peneliti tidak mengetahui tentang status intervensi dari subyek penelitian.
Hal ini untuk mencegah bias informasi).
d) Adanya restriksi (menerapkan kriteria inklusi dan eksklusi dalam memilih
subjek untuk penelitian, sehingga semua subjek penelitian memiliki level
atau kategori faktor perancu atau confounding factor yang sama).Intention to
threat analysis (semua subjek yang menerima maupun tidak menerima
intervensi, menyelesaikan maupun tidak menyelesaikan intervensi dianalisis,
sesuai dengan hasil randomisasi).
2.3 Faktor – faktor yang mempengaruhi RCT
Adapun beberapa faktor yang mempengaruhi percobaan dari studi
penelitian RCT yaitu:
a) Ukuran sampel :Semakin besar sampel maka semakin akurat
hasilnya.
b) Stratifikasi :Cara untuk memastikan kelompok perlakuan
seimbang dengan kelompok kontrol.
c) Trial Design :Cara untuk melakukan percobaan
d) Grup Kontaminasi :Bagian yang akan mengganggu jalannya uji.
e) Ethical Issue :Apakah percobaan sudah sesuai dengan kode etik
yang sudah ada.

3
2.4 Kelebihan dan Kelemahan RCT
Studi RCT mempunyai Kelebihan dan kekurangan yaitu sebagai berikut:

 Kelebihan:
a) Faktor bias dapat dikontrol secara efektif karena faktor perancu telah dibagi
secara seimbang.
b) Telah dilakukan kriteria inklusi.
c) Dari segi statistika lebih efektif karena jumlah kelompok perlakuan dan
kontrol sebanding.
d) Pemilihan peserta secara random sangat menguntungkan uji klinis secara
teori.
 Kekurangan:
a) Desain dan pelaksanaan yang kompleks dan mahal.

b) Masalah etika memberikan perlakuan yang dihipotesiskan merugikan, atau

tidak memberikan perlakuan yang bermanfaat.
c) Uji klinis terkadang harus dilakukan seleksi tertentu sehingga tidak
merepresentasikan populasi.
d) Jika ukuran sampel terlalu kecil, randomisasi gagal mengontrol faktor
perancu.
e) Jika waktu perlakuan terlalu pendek, RCT tidak mampu menunjukan efek
perlakuan yang sesungguhnya.

2.5 Perhitungan sampel pada studi RCT

Tujuan perhitungan studi RCT untuk menetukan banyaknya jumlah sampel
sebelum dimulainya studi RCT. Cara perhitungan sampel studi RCT yaitu:

Keterangan :

n1 dan n2 : Jumlah subjek kelompok perlakuan dan placebo

Zα : Deviat baku normal untuk kesalahan tipe 1
Zβ : Deviat baku normal untuk kesalahan tipe 2
P1 : Proporsi efek standar (dari pustaka)
P2 : Proporsi efek yang diteliti (ditetapkan peniliti)
P : Setengah x (P1 + P2)

4
2.6 Menganalisis Data Statistik RCT
Dari jurnal “Randomized Controlled Trial Quality in Pediatric Physical
Therapy” bertujuan menggambarkan kualitas RCT yang dilaporkan dalam terapi
fisik anak(PPT) dan perubahan seiring waktu. Alat dan metode yang digunakan
untuk menilai kualitas intervensi terapi fisik uji klinis yaitu Physiotherapy
Evidence Database(PEDro). PEDro adalah database gratis dari uji acak, ulasan
sistematis dan pedoman praktik klinis dalam fisioterapi. Setiap catatan pada PEDro
dikategorikan menggunakan serangkaian kode PEDro untuk subdisiplin fisioterapi
(misalnya, "pediatrik"). Kriteria khusus digunakan untuk menentukan uji klinis,
tinjauan sistematis, dan pedoman praktik klinis berbasis bukti apa yang diarsipkan
dalam PEDro. Setelah diarsipkan, semua RCT di PEDro secara independen dinilai
kualitasnya oleh dua penilai. Penilai ketiga menyelesaikan perselisihan apa pun.
Ketika ini telah dilakukan, proses peringkat dikompilasi. Kualitas RCT dari waktu
ke waktu diselidiki dengan empat analisis yang berbeda:
1. skor total setiap artikel yang dipilih dan tahun publikasi dikorelasikan
menggunakan koefisien korelasi Pearson
2. setelah mengelompokkan skor PEDro berdasarkan dekade publikasi, uji
nonparametrik Jonckheere-Terpstra (JT) digunakan untuk memverifikasi
apakah tema dari skor PEDro meningkat dari dekade ke dekade
3. Pelajar t- uji digunakan untuk membandingkan skor rata-rata PEDro dari uji
coba yang diterbitkan sebelum dan sesudah penerbitan daftar periksa
CONSORT (1996) untuk menguji hipotesis bahwa ini telah meningkatkan
deskripsi metodologis RCT
4. Regresi berganda bertahap dilakukan untuk menguji apakah bertahun-
tahun dan pengenalan checklist THEONSORT secara signifikan terkait
dengan total

5
 Mendapatkan hasil yaitu Seribu tiga ratus enam puluh tujuh (1.367) RCT
terkait dengan PPT dan diterbitkan setelah 1962 diindeks pada PEDro dan
diekstraksi untuk penelitian ini. Jumlah RCT yang diterbitkan setiap tahun telah
meningkat dari waktu ke waktu (Gambar 1 dan 2). Skor PEDro berkorelasi
signifikan dengan tahun ( r = 0,28; p < . 001), menunjukkan skor PEDro yang lebih
tinggi dikaitkan dengan tahun publikasi yang lebih baru (Gambar 3). Tahun yang
diterbitkan menjelaskan 7,7% dari variabilitas dalam skor PEDro ( R 2 = 0,077).
Dengan batas standar PEDro dari ≥ 6, hanya 29% dari artikel ( n = 391)
diklasifikasikan sebagai penelitian berkualitas tinggi, sambil menggunakan cut-off
yang dimodifikasi ≥ 5 persentase meningkat menjadi 56% ( n = 757). Ketika
mempertimbangkan tren dalam skor rata-rata per dekade, peningkatan yang stabil
dapat diamati. Rata-rata, skor PEDro telah meningkat setiap dekade sebesar 0,63
poin (JT = 8,87, p < . 001) (Gambar 4). Persentase RCT yang memenuhi kriteria

6
untuk setiap item pada skala PEDro tercantum pada Gambar 5. Item dengan
persentase terendah adalah: ahli terapi buta (0,6%; n = 8), analisis intention-to-treat
(15,5%; n = 209); alokasi terselubung (19,9%; n = 269), dan penilai buta (31,1%; n
= 420). Ada juga sedikit efek dari pengantar checklist CONSORT pada tahun 1996:
membagi sampel menjadi dua kelompok, yang pertama terdiri dari tahun 1962–
1995 dan yang kedua terdiri dari tahun 1996–2011, peningkatan signifikan dalam
skor rata-rata dalam kelompok kedua diamati (4.2 ± 1.3 dibandingkan dengan 5.0 ±
1,5, p < . 001). Namun, beberapa regresi tidak menunjukkan efek independen dari
pengenalan daftar periksa CONSORT pada total skor PEDro.

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8
 BAB III
PENUTUP

3.1 Kesimpulan
RCT (Randomized Controlled Trial) adalah eksperimen epidemiologis
dimana subjek dalam suatu populasi dialokasikan secara acak kedalam kelompok,
biasanya disebut kelompok studi dan control untuk menerima dan tidak menerima
prosedur, manuver, atau intervensi eksperimental preventif atau terapi (John
M.Last,2001). Jenis – jenisnya ada open trial, single mask, double mask dan triple
mask. Karakter dari RCT yaitu adanya randominasi, memberikan tingkat perlakuan
yang berbeda pada subjek penelitian, adanya blinding dan restriksi. Faktor – faktor
yang mempengaruhi yaitu ukuran sampel, statifikasi, trial design, grup kontaminasi
dan ethical issue. Adapun kelebihan dan kekurangan dari studi RCT serta cara
perhitungannya.
Jumlah RCT di PPT diterbitkan setiap tahun dan kualitas metodologis RCT
telah meningkat antara 1962 dan 2012. Temuan ini memiliki implikasi untuk
praktik berbasis bukti. Meskipun ada peningkatan dalam kualitas metodologis
RCT, hanya 29% dari studi memenuhi kriteria untuk kualitas tinggi (skor ≥ 6);
sementara 56% dianggap berkualitas tinggi ketika skor cut-off yang dimodifikasi
digunakan (skor ≥ 5). Penilai yang menyilaukan, alokasi tersembunyi, dan analisis
intention-to-treat adalah tiga kriteria yang harus dipertimbangkan peneliti ketika
merancang RCT untuk PPT. Penggunaan pernyataan CONSORT dalam merancang
dan melaporkan hasil sangat disarankan.

9
 DAFTAR PUSTAKA

Dinda Syeba Hasianna. 2015. Desain Studi Epidemiologi. Fakultas

Kedokteran:Universitas Sriwijaya.

Kabisch, M., Ruckes, C., S.G, M., & Blettner, M. (2011). Randomized Controlled
Trials. Evaluation of Scientific Publications, 661.

Kabisch maria, Dkk. 2011. Randomized Controlled Trials. Deutsches Arzteblatt

International: Germany.

10
Physical & Occupational Therapy in Pediatrics, 34(3):260–270, 2014

ⓍC 2014 by Informa Healthcare USA, Inc.

Available online at http://informahealthcare.com/potp DOI:

10.3109/01942638.2013.827142

ORIGINAL RESEARCH

Randomized Controlled Trial Quality in Pediatric

Physical Therapy

Matteo Paci, PT, Msc1, Niccolo` Landi, PT2, Mariangela

Marchettini, PT1, & Marco Baccini, MSc3
1
Unit of Functional Rehabilitation, Prato Hospital, Prato, Italy, 2School of
Physiotherapy, University of Florence, Florence, Italy, 3Unit of Functional
Rehabilitation, Motion Analysis Laboratory, Azienda Sanitaria di Firenze, Florence,
Italy

ABSTRACT. The aim of this study is to describe the reported quality of randomized
controlled trials (RCTs) in pediatric physical therapy (PPT) and changes with time. All RCTs
sourced from PEDro database and scored using the PEDro scale were included. RCTs were
classified as high- or low quality both with the original cut-off of 6 and a modified cut-off of
5. The relationship between PEDro scores and year of publication was also investigated.
One thousand three hundred sixty-seven articles were analyzed. According to the PEDro
scale original and modified cut-off, 29% and 56% of the arti- cles were classified as high-
quality studies, respectively. The number of RCTs and the average PEDro score increased
between 1962 and 2012. However, since some items of the scale could be more frequently
satisfied, a further improvement of the quality of RCTs in PPT is recommended.

KEYWORDS. Child, methodological quality, pediatric physical therapy, pediatric physical

therapy research, randomized controlled trial

The randomized controlled trial (RCT) is traditionally considered the gold stan- dard
for examining the efficacy of interventions. Recent articles have shown a higher
number and a faster increase of RCTs in studies involving adult population, when
compared to pediatric literature (Cohen et al., 2010; Cohen, Uleryk, Jasuja, & Parkin,
2007; Martinez-Castaldi, Silverstein, & Bauchner, 2008; Thomson et al., 2010). In the
field of physical therapy, RCTs represent a small part of the totality of research
articles, but their rate is comparable to other disciplines (Kocak, Unver, & Karatosun,
2011; Paci, Briganti, & Lombardi, 2011; Paci, Cigna, Baccini, & Rinaldi, 2009). Some
authors suggest that there are population-related specific reasons for the lack of RCTs

1
in pediatric literature, such as parental reluctance to agree to the participation of their
children in research studies involving unproven treatments,

Address correspondence to: Dr Matteo Paci, Prato Hospital, Unit of Functional Rehabilitation, Via Bottego, 4 50127
Firenze, Prato, Italy (E-mail: mpaci@usl4.toscana.it)
(Received 29 August 2012; accepted 8 July 2013)

260

2
 RCT Quality in Pediatric PT 261

the difficulty of recruiting adequate sample sizes, in particular for uncommon con-
ditions, and ethical concerns (Caldwell, Murphy, Butow, & Craig, 2004; Thomson
et al., 2010).
In the pediatric physical therapy (PPT), specific barriers have been reported
for conducting clinical trials (Svien, Anderson, & Long, 2006), such as lack of
sensitive measurement tools, ambiguous description of interventions, natural
development of children over time, and the natural evolution and
pathophysiology of the health condition (Parette, Hendricks, & Rock, 1991).
These barriers may also account for the small number of RCTs. In fact, an
analysis of the type of articles published in the journal PPT indicated that only 4
RCTs (1.5% of total published articles) were published within the first 15 years
of publication (1989 to 2003) (Svien et al., 2006). Poor methodological quality
can affect the internal and external validity of an RCT and the application of
results in clinical practice. A number of validated tools have been used in
pediatric research to evaluate methodological quality of an RCT such as Jadad
scale (Cohen et al., 2007; Thomson et al., 2010) and the Consoli- dated
Standards of Reporting Trials (CONSORT) statement (Anttila, Malmivaara,
Kunz, Autti-Ra¨ mo¨ , & Ma¨ kela¨ , 2006; DeMauro, Giaccone, Kirpalani, &
Schmidt, 2011). Anttila et al., (2006) found that only a small number of RCTs
on the effec- tiveness of physical therapy for children with cerebral palsy
extensively reported criteria for methodological quality included on the
CONSORT checklist. In addi- tion, reported quality of RCTs published in
2005–2009 in six pediatric or general medical journals was found to be poor,
particularly in pediatric journals (DeMauro et al., 2011). On the other hand,
Thomson et al. (2010) showed a significant increase over time of
methodological quality, assessed with the Jadad score, in a sample of
578 trials extracted from the Trials Register of the Cochrane Child Health Field.
The most widely used tool to assess the quality of physical therapy
interventions clinical trials is the Physiotherapy Evidence Database (PEDro)
score (Olivo et al., 2008), which seems to be a more comprehensive measure of
methodological qual- ity when compared to Jadad score (Bhogal, Teasell,
Foley, & Speechley, 2005). A recent paper by Moseley, Herbert, Maher,
Sherrington, & Elkins (2011) reported an improvement with time of the total
PEDro score for physical therapy interven- tions clinical trials, which increased
by an average of about 0.6 points each decade between 1960 and 2009.
Despite previous studies to assess reported quality of RCTs in pediatric
(Anttila et al., 2006; DeMauro et al., 2011; Thomson et al., 2010) or physical
therapy lit- erature (Moseley et al., 2011), no investigation assessed
methodological quality specific to PPT. The aim of this study was to assess the
reported quality of RCTs published in the PPT using a standardized scale and
evolution of methodological quality over time.

METHODS
A search of the PEDro database was carried out for articles published after
1962 through May 9, 2012, limited to “pediatric” subdiscipline and “clinical tri-
als” method. PEDro is a free database of randomized trials, systematic reviews
and clinical practice guidelines in physiotherapy. Each record on PEDro is cat-
261
 RCT Quality in Pediatric PT 262
egorized using a series of PEDro codes for the subdiscipline of physiotherapy

262
(e.g., “pediatric”). Specific criteria are used to define which clinical trials, system-
atic reviews, and evidence-based clinical practice guidelines are archived in PEDro.
Once archived, all RCTs on PEDro are independently assessed for quality by two
raters. A third rater resolves any disagreements. When this has been done the rat-
ing process is compleded. (source: http://www.pedro.org.au/). Article title, journal
name, year of publication, ratings for each of the 11 items of the PEDro scale, and
total PEDro score of all RCTs that had complete PEDro scale ratings were down-
loaded from PEDro database.

Assessment of Reported Methodological Quality

The PEDro database provides the assessment of the reported methodological qual-
ity of each RCT using the PEDro scale (Moseley, Herbert, Sherrington, & Maher,
2002; Sherrington, Herbert, Maher, & Moseley, 2000). The PEDro scale was devel-
oped specifically to assess studies aimed at comparing the effectiveness of rehabil-
itation interventions. The PEDro scale rates 11 aspects of methodological quality
of RCTs as being either absent or present (Table 1). (Full explanation of criteria
is available in http://www.pedro.org.au/english/downloads/pedro-scale/.) The first
item (eligibility criteria) is not scored because it does not relate to internal validity
or statistical reporting, therefore the total score ranges from 10 (RCT that satisfies
all criteria) to 0 (RCT that does not satisfy any of the criteria). The PEDro scale
also allows the quality of the articles to be classified as high or low according to a
cut-off score: articles that obtain a total score lower than 6 points are considered
to be low-quality studies, while articles with a total score equal to or exceeding 6
points are considered to be high-quality ones (Maher, Sherrington, Herbert, Mose-
ley, & Elkins, 2003). Considering that it is almost impossible to obtain blinding of
therapists or subjects in most of physical therapy trials (e.g., when control group
receives no interventions or when therapists directly provide the interventions),
Maher (2000) has suggested the use of a modified cut off of 5 points. For this study,
both cut-off scores were examined.
The PEDro Scale total score has been shown to be reliable for use in systematic
reviews of physical therapy RCTs (Maher et al., 2003). There is evidence for its
construct validity (de Morton, 2009), convergent validity (Macedo, Elkins, Maher,
Moseley, Herbert, & Sherrington, 2010), discriminative validity, face validity, and
content validity (Olivo et al., 2008).

Data Analysis
The quality of RCTs over time was investigated with four different analyses:
(1) the total score of each selected article and the year of publication were
correlated using the Pearson correlation coefficient (r), (2) after clustering
PEDro scores on the basis of decades of publication, the Jonckheere–Terpstra
nonparametric test (J-T) was used to verify whether the medians of the PEDro
scores increased decade after decade; (3) the Student t-test was used to compare
the PEDro mean scores of trials published before and after the publication of
the CONSORT checklist (1996) to test the hypothesis that this has improved the
methodological description of the RCT; (4) A stepwise multiple regression was
performed to test if years and the introduction of the CONSORT checklist were

263
significantly associated with the total

264
TABLE 1. PEDro Scale Items

1. Eligibility criteria
This criterion is satisfied if the report describes the source of subjects and a list of criteria used to
determine who was eligible to participate in the study.

2. Random allocation
A study is considered to have used random allocation if the report states that the allocation was
random. The precise method of randomization need not be specified.

3. Concealed allocation
Concealed allocation means that the person who determined if a subject was eligible for inclusion in
the trial was unaware, when this decision was made, of which group the subject would be
allocated to.

4. Baseline comparability
In studies of therapeutic interventions, the report must describe at least one measure of the severity
of the condition being treated and at least one (different) key outcome measure at baseline.

5. Blind subjects
6. Blind therapists
7. Blind assessors
Critera 5–7. Blinding means the person in question (subject, therapist or assessor) did not know
which group the subject had been allocated to. In trials in which key outcomes are self-reported, the
assessor is considered to be blind if the subject was blind.

8. Adequate follow-up
This criterion is only satisfied if the report explicitly states both the number of subjects initially
allocated to groups and the number of subjects from whom key outcome measures were obtained.
In trials in which outcomes are measured at several points in time, a key outcome must have been
measured in more than 85% of subjects at one of those points in time.

9. Intention-to-treat analysis
An intention to treat analysis means that, where subjects did not receive treatment (or the control
condition) as allocated, and where measures of outcomes were available, the analysis was
performed as if subjects received the treatment (or control condition) they were allocated to.

10. Between-group comparisons

A between-group statistical comparison involves statistical comparison of one group with another.
Depending on the design of the study, this may involve comparison of two or more treatments, or
comparison of treatment with a control condition.

11. Point estimates and variability

A point measure is a measure of the size of the treatment effect. The treatment effect may be
described as a difference in group outcomes, or as the outcome in (each of) all groups. Measures of
variability include standard deviations, standard errors, confidence intervals, interquartile ranges (or
other quantile ranges), and ranges.
Source (modified): http://www.pedro.org.au/english/downloads/pedro-scale/

PEDro score. The level of statistical significance was set at .05. Data were analyzed
using SPSS 13.0 software for Windows.

RESULTS
One thousand three hundred sixty-seven (1,367) RCTs related to PPT and pub-
265
=
lished after 1962 were indexed on PEDro and extracted for this study. The
number of RCTs published each year has increased over time (Figures 1 and 2).
The PE- Dro score is significantly correlated with years (r 0.28; p < .001),
indicating higher PEDro scores are associated with more recent year of
publication (Figure 3). The
year published explained 7.7% of the variability in PEDro score (R2 = 0.077). With

266
 100

90

80

70

No of articles
60

50

40

30

20

10

Years

FIGURE 1. Number of RCTs in pediatric physical therapy indexed in the PEDro

database published each year between 1962 and May, 2012.

the standard PEDro scale cut-off of≥6, only 29% of articles (n=391) were clas-
sified high-quality studies, while using the modified cut-off of≥5 the percentage
increased to 56% (n =757). When considering the trend in the average score by
decade, a steady increase can be observed. On average, the PEDro score has in-
= p < .001) (Figure 4).
creased each decade by 0.63 points (J-T 8.87,
The percentage of RCTs that met the criteria for each item on the PEDro
scale is listed in Figure 5. The items with the lowest percentages were: blind
therapists=(0.6%; n 8), intention-to-treat analysis (15.5%; n 209); concealed
allocation (19.9%;
= n 269), and blind assessors (31.1%; n 420). There was also a
slight effect of the introduction in 1996 of the CONSORT checklist: dividing
the sample into two groups, the first comprising the years 1962–1995 and the
second comprising the years 1996–2011, a significant increase in the average
score in the second group

800

700

600
No of articles

500

400

300

200

100

0
1962 - 1971 1972 - 1981 1982 - 1991 1992 - 2001 2002 - 2011

267
 Decades

FIGURE 2. Number of RCTs in pediatric physical therapy indexed in the PEDro database
published each decade.

268
 6

PEDro score
4

Year

FIGURE 3. Mean PEDro score per year for RCTs in pediatric physical therapy indexed in
the PEDro database.

was observed (4.2±1.3 compared with 5.0 1.5, p < .001). However, multiple re-
gressions did not show an independent effect of the introduction of the
CONSORT checklist on the total PEDro scores.

DISCUSSION
With the standard PEDro scale cut-off of 6-points (Maher et al., 2003), less than
30% of RCTs related to PPT and indexed in the PEDro database were classified
as high-quality studies. Since in most physical therapy clinical trials the blinding
of subjects and of therapists can hardly be achieved, Maher (2000) proposed to re-
duce the cut-off from the original 6 points to a less rigid 5 or even 4 points.
However, since the PEDro scale has been specifically designed and developed for
evaluation

269
FIGURE 4. Mean PEDro score per decade for RCTs in pediatric physical therapy indexed
in the PEDro database.

270
 100% 94% 94%
87%

75%
80%
65%
60%
60%

40% 31%

20%
15%
20%
6%
1%

0%
Eligibility criteria

Blind subjects

Adequate follow-up
Baseline comparability

Blind therapists

Blind assessors

Between-group comparisons
Intention-to-treat analysis

Point estimates and variability

Concealed allocation
Random allocation

FIGURE 5. Percentage of RCTs in pediatric physical therapy indexed in the PEDro

database that met the criteria for each item on the PEDro scale.

of physical therapy interventions, we can assume that this aspect was

considered in the development process of the scale. Despite this, there are
difficulties in blinding participants and therapists. Indeed, we found that
participants and thera- pists were blinded only in 5.6% and 0.8% of the RCTs,
respectively. In addition, Moseley et al. (2011), in a study that analyzed the
methodological quality of RCTs in physical therapy over time, the subjects’ and
therapists’ blinding were the only two PEDro scale items that did not increase
over time, always keeping a very low level. Therefore, the modified cut-off in
classifying articles’ quality was also used for this study. Removing from the
scale items 6 and 7 (blinding of the subjects and blinding of therapists,
respectively), the maximum value of the scale is 8 points; we chose the cut-off
at 5 points, and not at 4, according to the same criterion of the original cut-off
determination, that is, half of the maximum score plus one.
Furthermore, it has been shown that none of the items in the PEDro scale has
a perfect reliability regarding the consensus among the raters in the articles
scoring (Maher et al., 2003); the PEDro scores for studies indexed in the
database may therefore contain some degree of error. It was noted that the
standard error in the measurement of the total score is 0.70 points; this aspect
should be considered when determining if an article is high or low quality
(Maher et al., 2003). Since 45% of articles were scored as 5/10 or 6/10 and 51%
271
as 4/10 or 5/10 (i.e., scores close to the original and modified cut-off,
respectively), this limit should be taken into account.

272
Using the modified cut-off, in fact, the number of RCTs classified as studies
with high quality is almost doubled.
Additional limits of the PEDro scale should be considered in interpreting our
results. First, the scale assesses only the internal validity of a trial (criteria 2–9)
and the presence of statistical information (criteria 10–11). In addition, The PE-
Dro scale should not be used as a measure of the “validity” of a study’s
conclusions on the evidence that the treatment studied in each trial is clinically
useful. In fact, the scale does not consider elements such as the statistical power
of the study, reli- ability and validity of the outcome measures for the
population assessed; whether the statistical analysis was appropriate.
Reported quality of RCTs increased significantly over time, as shown in
Figures 3 and 4, both in annual trend and when comparing decades. On an
average, the total PEDro score increased by 0.63 points per decade. This
finding is comparable to results of the study by Moseley et al. (2011), which
found an average increase of 0.6 points per decade of the quality of research in
the whole field of physical therapy. Conversely, two previous studies on
physical therapy research found that change in the quality of RCTs over time
was negligible (de Morton, 2009), when compared to other research fields
(Falagas, Grigori, & Ioannidou, 2009). These au- thors, however, assessed a far
smaller number of articles than Moseley et al. (2011). Previously, poor
methodological quality was reported for RCTs of physical ther- apy
interventions for cerebral palsy (Anttila et al., 2006; Siebes, Wijnroks, & Ver-
meer, 2002). Our results discourage common beliefs that performing high-
quality experimental research in the PPT field is more difficult than in other
fields of phys- ical therapy since the increase over time of both the quality and
the number of published RCTs in PPT appears to be similar to the increase
found in the general physical therapy field.
Despite this positive trend, our findings indicate that the quality of RCTs in
PPT is still too low. In fact, if the scarce frequency of blinding subjects and
therapists can be justified by objective difficulties in meeting these
methodological requirements, this is not the case for the blinding of assessors,
which occurred in only 31.1% of the studies evaluated. Even lower frequencies
are observed for item 3 (Concealed allocation) and for item 9 (Intention-to-treat
analysis) of the PEDro scale, that are satisfied in 19.9% and 15.5% of the
studies, respectively. These percentages are similar to findings in other research
fields (Huwiler-Mu¨ ntener, Ju¨ ni, Junker, & Egger, 2002).
Each item of the PEDro scale, when not satisfied, represents a distinctive
source of bias: the higher the number of sources of bias, the higher the threat to
the valid- ity of results. In this perspective, the original 6 points cut-off of the
PEDro scales is likely more appropriate to discriminate between low- and high-
quality studies and the lack of assessor blinding, concealed allocation and
intention-to-treat analysis becomes even more critical when other potential
sources of bias (patients or thera- pist blinding) can hardly be removed.
Researchers should realize that, since blind- ing of participants and therapists
can rarely be obtained, greater efforts should be made in order to meet other
criteria that may be easily fulfilled. Disappointedly, most of included articles do
not meet also these three items of the PEDro scale (i.e., 3, 7, and 9), in addition
to items 5 and 6. Therefore, we judge the positive trend toward the

273
improvement of research quality over years as still too weak and

274
conclude that the quality of research in pediatric physiotherapy needs to be
further increased.
In our sample, as described for general physical therapy (Moseley et al.,
2011), the introduction of the CONSORT list had no appreciable effect on the
total PE- Dro score. The document, constantly evolving and subject to periodic
revisions, was produced by the CONSORT Group and was published for the
first time in 1996 (Begg et al., 1996). However, grouping the trials as published
before and af- ter 1996 may not reflect the real impact of the CONSORT
checklist. Likely, both authors and journals started using the CONSORT as a
guide to conduct and report RCTs later than 1996. Indeed, a long time is
generally spent to obtain funding for research, conduct the trial, analyze and
publish results, and this is true especially for RCTs. Conceivably, the positive
effect of the introduction of the CONSORT statement on the quality of
physiotherapy research will be fully disclosed in the next years.
Some potential limitations may have introduced bias in this study. First, the
re- ported quality may differ from the true methodological quality, because trial
re- ports frequently omit important methodological details (Huwiler-Muntener
et al., 2002). However, reported trial quality is generally the only available
information for considering the published results from individual trials
(Moseley, Herbert, Ma- her, Sherrington, & Elkins, 2008). Moreover, a
potential study selection bias may be due to the use of PEDro database alone as
data source. However, recent analy- ses show that PEDro is one of the more
comprehensive databases for intervention studies in physical therapy (Michaleff
et al., 2011).

CONCLUSIONS
The number of RCTs in PPT published each year and the methodological qual-
ity of RCTs has increased between 1962 and 2012. This finding has
implications for evidence-based practice. Despite improvements in
methodological quality of RCTs, only 29% of the studies met the criterion
≥ for
high quality (score 6);
≥ while 56% were considered high quality when the modified cut-off score was
used (score 5). Blinding assessors, concealed allocation, and intention-to-treat
analysis are three criteria that researchers should consider when designing
RCTs for PPT. Use of the CONSORT statement in designing and reporting
results is highly advisable.

Declaration of Interest: The authors report no declarations of interest. The

authors alone are responsible for the content and writing of this article.

ABOUT THE AUTHORS

Matteo Paci, PT, Msc, and Mariangela Marchettini, PT, are affiliated with the
Unit
of Functional Rehabilitation, Prato Hospital, Prato, Italy. Niccolo` Landi, PT, is

275
affiliated with the School of Physiotherapy, University of Florence, Florence,
Italy. Marco Baccini, PT, MSc, is affiliated with the Unit of Functional
Rehabilitation, Motion Analysis Laboratory, Azienda Sanitaria di Firenze,
Florence, Italy.

276
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