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CRITICAL APPRAISAL
“INSPIRATORY MUSCLE TRAINING IN PATIENTS WITH HEART
FAILURE AND INSPIRATORY MUSCLE WEAKNESS”
DisusunOleh:
A. Latar Belakang
Dalam era globalisasi yang sangat pesat ini, kita sebagai seorang profesional
kesehatan harus mampu mengikuti perkembangan tersebut dengan terus memperkaya
pengetahuan dari berbagai sumber ilmiah, baik berupa buku ajar, mengikuti pelatihan,
seminar nasional dan internasional, atau membaca laporan ilmiah. Seperti yang kita
ketahui bersama, bahwa sumber ilmiah yang paling up date yang dapat memperkaya
pengetahuan kita sebagai profesi keperawatan adalah berasal dari jurnal ilmiah, baik
jurnal nasional maupun internasional. Dalam dunia kesehatan, membaca jurnal ilmiah
merupakan suatu metode yang efektif guna memperoleh pengetahuan baru. Sebagai
pelayan kesehatan, tujuan akhir membaca jurnal ilmiah adalah untuk menerapkan hasil
yang dilaporkan oleh peneliti kepada pasien.
Evidence-based medicine pendekatan pengambilan keputusan klinik, dimana
klinis ini menggunakan bukti ilmiah terbaik (best evidence) yang ada, dengan
konsultasi kepasien, memutuskan pilihan terbaik bagi pasien.Untuk menentukan bukti
“terbaik” diperlukan kemampuan critical appraisal. Critical appraisal merupakan
proses sistematis untuk menguji validitas, hasil, dan relevansi dari sebuah bukti ilmiah
(hasil penelitian) sebelum digunakan untuk mengambil keputusan. Critical appraisa
lmembantu kita untuk memahami metode dan hasilsebuah penelitian, membantu
dalam menganalis kualitas sebuah penelitian dan menjembatani jurang antara hasil
riset dengan aplikasi praktis.
Critical appraisal biasanya digunakan untuk beberapa desain penelitian,
diantaramya randomized controlled trial, cohortstudy, case-control Study,
diagnostictest. Randomized controlled trial merupakan metode yang umum yang
dikenal dalam ilmu kesehatan. Metode ini merupakan penelitian komparatif
eksperimental terkendali, dimana peneliti memberikan dua intervensi atau lebih
kepada pasien yang digunakan untuk sampel penelitian. Dalam penelitian ilmu
kesehatn, RCT biasanya digunakan untuk menguji keberhasilan atau efektifitas
pengobatan. Selain itu, metode ini juga digunakan untuk menguji keberhasilan dan
efektifitas tindakan medis. Bahkan RCT juga digunakan untuk menguji peralatan
medis.
Dibandingkan metode penelitian yang lain, hasil penelitian yang menggunakan
metode desain RCT paling layak untuk dipercaya. Hal ini disebabkan karena dalam
prakteknya, RCT mensyaratkan sampelnya menggunakan pasien atau manusia yang
sesungguhnya, tidak boleh menggunkan hewan percobaan. Selain itu model penelitian
membandingkan kelompok kontrol dengan kelompok intervensi dalam realitas
sesungguhnya.
B. Tujuan
Adapun tujuan dari penulisan makalah ini adalah mahasiswa mampu mengkritisi
jurnal sehingga mampu membuat penelitian yang berkualitas.
BAB 1I
CRITICAL APPRAISAL FOR RANDOMISED CONTROLLED TRIALS
Judul : Inspiratory Muscle Training in Patients With Heart Failure and Inspiratory
Muscle Weakness
Teknik : CASP’s 11 questions
2. Apakah penelitian ini randomised controlled trial (RCT) dan apakah sesuai
dengan metode tersebut? (Ya)
Penelitian ini menggunakan randomised controlled trial (RCT) atau merupakan
penelitian eksperimental. Metode ini merupakan metode yang paling dapat dipercaya.
Penelitian dimulai dengan pengelompokan pasien yang menjadi sampel
penelitian dengan menggunakan metode randomized dan dibagi menjadi dua
kelompok. Satu kelompok merupakan kelompok perlakuan dan satu kelompok
merupakan kelompok kontrol. Kemudian dua kelompok tersebut dibandingkan
dalam realitas yang sesungguhnya.
Efek dari intervensi akan meningkatkan kapasitas fungsional dan kualitas hidup pasien
CHF. Batas kepercayaan yang digunakan adalah 5%. Pada penelitian didapatkan hasil
yang signifikan, yaitu : Setelah dilakukan intervensi pada kelompok intervensi PImax
(p = 0.001), Six-minute walk test menggunakan ANNOVA, p = 0.002, qualitas hidup
menggunakan ANNOVA , p =0.001.
9. Apakah hasil penelitian dapat diterapkan menurut anda? Atau dapat diterapkan
untuk penduduk lokal (ya)
Hasil penelitian ini dapat diterapkan di penduduk lokal atau pada pasien CHF, akan
tetapi bisa dilakukan dengan melakukan latihan otot inspirasi dengan melakukan
manual atau tanpa alat Threshold otot inspirasi, yaitu dengan melakukan pernafasan
diafragma.
(P-IMT, 16 patients). The following measures were obtained before and after the program:
P I m ax at rest and 10 min after maximal exercise; peak oxygen uptake, circulatory power,
ventilatory oscillations, and oxygen kinetics during early recovery (V˙O 2 /t slope); 6-min walk
test; and quality of life scores.
RESULTS The I M T resulted in a 115% increment P I m ax , 17% increase in peak oxygen uptake, and 19%
increase in the 6-min walk distance. Likewise, circulatory power increased and ventilatory
oscillations were reduced. The V˙O 2 /t slope was improved during the recovery period, and
quality of life scores improved.
CONCLUSIONS In patients with C H F and inspiratory muscle weakness, I M T results in marked improvement
in inspiratory muscle strength, as well as improvement in functional capacity, ventilatory
response to exercise, recovery oxygen uptake kinetics, and quality of life. (J Am Coll Cardiol
2006;47:757– 63) © 2006 by the American College of Cardiology Foundation
Most patients with chronic heart failure (CHF) are limited contradictory (8 –11). Nonrandomized trials (8,11) have
in their physical activity by fatigue and dyspnea, and it has shown improvement in maximal functional capacity after
been suggested that respiratory muscle weakness and decon- inspiratory muscle training, but these beneficial effects have
ditioning may be involved in the increased work of breath- not been confirmed by randomized studies (9,10). More-
ing during hyperpnea (1). Some of these patients show over, the effects of inspiratory muscle training on several
reduced maximal inspiratory pressure (P I max) and endurance markers of prognosis obtained from cardiopulmonary exer-
of inspiratory muscles, which are currently recognized as cise testing (CPET) have not been previously reported.
additional factors implicated in the limited exercise response Therefore, we conducted this randomized trial to test the
and quality of life, as well as in their poor prognosis (2). hypothesis that a 12-week program of inspiratory muscle
Abnormal ventilatory response to exercise (3), periodic training could be associated with improvement in functional
breathing (4), and delayed oxygen uptake kinetics during capacity, circulatory power, oscillatory ventilation, kinetics
recovery of maximal effort (5) have also been associated with of oxygen consumption in the recovery period, and quality
severity of and poor prognosis in CHF . The precise cause of of life in patients with C H F and inspiratory muscle
this respiratory muscle dysfunction remains speculative, but weakness.
diaphragm biopsies have shown a variety of histological
abnormalities in CHF , including fiber type I atrophy (6), METHODS
which have been implicated in a generalized skeletal muscle
Patients and design. A prospective, randomized, controlled
disorder in C H F (7).
trial was conducted in patients with the diagnosis of C H F
Few studies have evaluated the effects of inspiratory
attributable to left ventricular systolic dysfunction (left
muscle training in patients with CHF , and their results are
ventricular ejection fraction 45%) who were recruited
from the Heart Failure Clinic at the Hospital de Clínicas de
From the *Department of Physiological Sciences, Fundação Faculdade Federal de
Porto Alegre. Entry criteria for the study were a previous
Ciências Médicas de Porto Alegre, Porto Alegre, Brazil; †School of Physical Therapy,
U NILAS ALL E, Canoas, Brazil; ‡Cardiology Division, Hospital de Clínicas de history of symptomatic heart failure caused by left ventric-
Porto Alegre, Porto Alegre, Brazil; and the §Department of Medicine, Faculty of ular systolic dysfunction, inspiratory muscle weakness (P I max
Medicine, UFRGS, Porto Alegre, Brazil. Supported by grants from: CAPES and
70% of the predicted), and clinical stability, including no
CNPq, Brasília, Brazil, and FIPE-HCPA, Porto Alegre, Brazil.
Manuscript received May 24, 2005; revised manuscript received August 21, 2005, change in medications for the past three months. Exclusion
accepted September 26, 2005. criteria were unstable angina, myocardial infarction, or cardiac
758 Dall’Ago et al. JACC Vol. 47, No. 4, 2006
Inspiratory Muscle Training in Heart Failure February 21, 2006:757–63
Table 1. Baseline Characteristics of Patients Randomized to where y corresponds to V˙O 2, V˙CO 2, or V˙E in time, a
P-IMT or I M T corresponds to the slope, k is a constant, and t stands for the
P-IMT IMT time.
Group Group Quality of life. Quality of life was assessed with the
Characteristic (n 16) (n 16) p Value*
Minnesota Living With Heart Failure Questionnaire (20).
Gender, male/female 10/6 11/5 0.60† We analyzed overall scores as well as the separate effects of
Age, yrs 58 2 54 3 0.21 physical and psychological perceptions of quality of life.
Body mass index, kg·m 2 27 5 27 4 0.86
Statistical analysis. Data were analyzed on the Statistical
Etiology of heart failure, n
Ischemic 7 6 0.90† Package for Social Sciences (version 10.0, SPSS, Chicago,
Non-ischemic 9 10 0.60† Illinois). Based on the results of previous studies (8), we
Ejection fraction, % 38 3 39 3 0.79* estimated that a sample size of 15 individuals in each group
Forced expiratory volume in 90.1 12.6 83.7 14.5 0.20* would have a power of 80% to detect a 10% difference in
1 s, % predicted
peak oxygen uptake, for an 0.05. Descriptive data are
Forced vital capacity, 84.7 8.8 85.3 13.4 0.96*
% predicted presented as mean SD. Baseline data were compared by
P I max, kPa 5.7 0.1 5.9 0.9 0.29* the Student t test for continuous variables or by the Fisher
P I max , % predicted 59.8 2 59.5 2.2 0.89* exact test for categorical variables. The Pearson correlation
1 1
V˙O 2 peak, ml·kg ·min 17 0.7 17.2 0.5 0.75* coefficient was used to evaluate associations. The effects of
Drugs, %
interventions on continuous variables were compared by
Diuretics 80 86 0.82†
Digoxin 50 57 0.79† two-way analysis of variance for repeated measures
Angiotensin-converting 78 85 0.86† (ANOVA), and post-hoc analysis was conducted by the
enzyme inhibitors Tukey test. Categorical data were analyzed by the chi-
Beta-blocker 50 42 0.10† square statistic.
Values are expressed as mean standard deviation. *Student t test. †Fisher exact test.
IMT inspiratory muscle training; P-IMT placebo-inspiratory muscle
training; PI max maximal static inspiratory pressure; V˙O 2peak peak oxygen uptake. RESULTS
Ventilatory efficiency was estimated using the relation- Patients. Between August 2001 and November 2003,
ship between minute ventilation (V˙E) and carbon dioxide 144 patients with CHF were screened for the study.
output (V˙CO 2), i.e., V˙E/V˙CO 2 slope, by linear regression Ninety-six patients did not meet the inclusion or met the
model using all data points obtained during CPET (3). The exclusion criteria, and therefore, 44 patients were ran-
relative amplitudes of oscillations ( ) in V˙E, V˙O 2, and V˙CO 2 domized. For the 22 patients randomized to IM T, 1 had a
were calculated for every 20-s period as the ratio between myocardial infarction, 1 developed atrial fibrillation, and 4
amplitude and its respective mean throughout the test. The were not able complete the training protocol. For the 22
ratio between metabolic ( V˙O 2, V˙CO 2) and ventilatory patients allocated to P-IMT, 2 had to be excluded because
oscillations ( V˙ O 2/ V˙E, V˙CO 2/ V˙E) were also calculated of indication of coronary artery bypass graft surgery, 3 for
(19). The V˙O 2, V˙CO 2, and V˙E kinetics during the first 3 min the development of symptoms at rest, and 1 because of
of the recovery period were calculated by a linear regression bleeding secondary to oral anticoagulation. Therefore, 16
model adjusted to a simple exponential curve (V˙O 2/t, V˙CO 2/ patients completed the protocol in each group. Table 1
t, V˙E/t slope) (1). The time required for a 50% decrease describes the clinical characteristics for both groups. Etiol-
from the V˙O 2peak (T 1/2V˙O 2), V˙CO 2peak (T 1/2V˙CO 2) and V˙E ogy of C H F was predominantly non-ischemic, and patients
peak (T 1/2V˙E) was calculated using the mathematical model had mild to moderate left ventricular dysfunction as well as
e( kt)
of the minimum squares through the equation y a , mild to moderate impairment in functional capacity. Pa-
Table 2. Pulmonary Function and Inspiratory Muscle Function Tests Before and After
Intervention for Patients Randomized to P-IMT or I M T
P-IMT IMT
(n 16) (n 16)
Table 3. Results Obtained in the Maximal Cardiopulmonary Exercise Test for the P-IMT and
the I M T Group
P-IMT IMT
(n 16) (n 16)
13 after [ANOVA 0.001 for group, training, and inter- tained after one year of follow-up in patients with C H F and
action effects]). The global improvement was attributed to a weakness of inspiratory muscles.
change in physical dimension from 6 3 to 3 5 because Inspiratory muscle strength and endurance. In accor-
no changes were observed in the psychological dimension of dance with previous studies (8 –11), I M T did not affect
the score. Despite the fact that IM T was stopped after 12 resting pulmonary function test results but had a major
weeks of intervention, patients who participated in the IM T impact on all measures of inspiratory muscle strength and
program maintained part of the effect on quality of life scores endurance. The magnitude of improvement in P I max (115%)
one year after starting the program, from 27 8 to 14 3 in our patients is larger than described in previous studies
(ANOVA 0.05 for group, training, and interaction effects). (8 –11), a finding that may be related to the fact that we used
a linear pressure resistance device with weekly adjustments
in load, resulting in possible training of other inspiratory
DISCUSSION muscles in addition to the diaphragm. Moreover, daily
In this randomized trial, a home-based, three-month I M T exercises and the presence of inspiratory muscle weakness in
program improved inspiratory muscle strength and endur- all patients may also have contributed to this increment.
ance as well as quality of life and functional capacity in The improvement in P I max after maximal exercise is consis-
patients with C H F and weakness in inspiratory muscles. tent with delayed development in diaphragmatic fatigue (1).
Moreover, I M T improved peak circulatory power, ventila- Functional capacity and quality of life. Patients who
tory efficiency, and oscillations during incremental exercise, participated in the I M T presented improvement in func-
as well as oxygen uptake kinetics during recovery, which are tional capacity as shown by a 19% increase in 6-min walk
all markers of poor prognosis in CHF . The efficacy of I M T distance, which was also accompanied by a reduction in the
was tested against a similar program with no inspiratory perception of dyspnea. Likewise, there was a 17% increase
load, which served as a placebo intervention, and outcomes in V˙O 2peak and a 24% increase in circulatory power,
were blindly evaluated. Interestingly, part of the effect on consistent with clinically significant improvement in
P I max and quality of life was sustained after one year, even cardiovascular and respiratory response to maximal exer-
though the patients did not continue training after four cise. The improvement in functional capacity and the
months. These data provide the first evidence showing that reduction in perception of dyspnea were probably respon-
the effects of I M T are consistent and are partially main- sible for the changes in the physical dimension of quality
762 Dall’Ago et al. JACC Vol. 47, No. 4, 2006
Inspiratory Muscle Training in Heart Failure February 21, 2006:757–63
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DAFTAR PUSTAKA
Dall’Ago, Pedro. Inspiratory Muscle Training in Patients With Heart Failure and
Inspiratory Muscle Weakness. Journal of the American College of Cardiology Vol. 47,
No. 4, 2006
Critical Appraisal Skill Program (CASP) Randomized Controlled Trial Check List
31.05.13. www.media.wix.com