Kuliah Wajib Ilmu Dasar

CRITICAL APPRAISSAL

EFFECTS OF GROWTH HORMONE AND NUTRITIONAL THERAPY IN

BOYS WITH CONSTITUTIONAL GROWTH DELAY: A RANDOMIZED
CONTROLLED TRIAL

dibuat untuk memenuhi persyaratan penilaian Kuliah Wajib Ilmu Dasar

dr. Tessa Rulianty

04022771822003
PPDS Prodi Ilmu Kesehatan Anak

Pembimbing:
dr. Theodorus, M.MedSc

FAKULTAS KEDOKTERAN
 UNIVERSITAS SRIWIJAYA
2018

CRITICAL APPRAISAL

Jurnal : “Effects of Growth Hormone and Nutritional Therapy in Boys with

Constitutional Growth Delay: A Randomized Controlled Trial”

1. What is the research question and/or hypothesis?

Research question :
To examine whether supplemental nutrition augments the anabolic actions of
growth hormone (GH) in boys with constitutional delay of growth and maturation
(CDGM)
Hypothesis
The nutritional supplementation would improve linear and ponderal growth
compared with observation and that nutrition would augment the anabolic effects
of GH compared with GH alone.

2. What is the study type?

A Randomized Controlled Trial, Single-Blind,

3. What is reference population ? what are the sampling frame and sampling
method ?
Population : 20 boys from patients seen at the Pediatric Endocrine Clinics in
Jacksonville, Florida, who met these inclusion criteria: age 7 to 11years, genital
Tanner stage 1, significant short stature (height ≤–2 standard deviation score
[SDS] or predicted adult height [PAH] >2 SD below midparental target height),
bone age ≤10 years and delayed by ≥1 year, with otherwise normal results on
physical examination.
 Sampling method : Each boy was randomized to either observation or aggressive
nutritional supplementation for 6 months. After 6months, GH therapy was
initiated in all subjects in both arms of the study and continued for a total of 12
months. Subjects who had been randomized to the nutrition group continued
nutritional supplementation for the full 18 months.

4. In an experimental study, how were subjects assigned to groups ?

Inclusion Criteria :
 To ensure that subjects did not have GH deficiency, all subjects had to have
normal GH responses to stimulation with standard secretagogues
(arginine/L-DOPA).
 Age 7 to 11 years
 Genital Tanner stage 1
 Significant short stature (height ≤–2 standard deviation score [SDS] or
predicted adult height [PAH] >2 SD below midparental target height)
 Bone age ≤10 years and delayed by ≥1 year, with otherwise normal results on
physical examination.

Exclusion Criteria:
 All other forms of endocrinopathies and other disorders impairing growth
were excluded, including chronic illnesses and skeletal dysplasias.
 Children that participating in highly competitive endurance sports activities.
Subjects who were receiving medications for attention deficit hyperactivity
disorder were required to maintain the same dosages in the 6 months before
the study and for the entire 18-month duration of the study.

5. What are the study factors and how they are measured ?
Study factor : Constitutional Growth Delay
How to measure :
 To ensure that subjects did not have GH deficiency, all subjects had to
have normal GH responses to stimulation with standard secretagogues
(arginine/L-DOPA).
 Anthropometric and Body Composition Measures
 Assays
6. What are the outcome factors and how are they measured ?
Outcome factors :
1. Primary Outcome : to measure the changes in linear growth and lean body
mass (LBM) accrual at 6 and 12 months
2. Secondary Outcome : the change in these same measures at 18 months,
Changes in TEE, ghrelin, insulin, and IGF-1 concentrations
How to measured :
 Anthropometric and Body Composition Measures
 Assays
 Doubly Labeled Water for Total Energy Expenditure (TEE) Assessment
 Dietary Records

7. What important potential confounders are considered?

This jurnal doesnt give an explanation about the confounder.

8. Are statistical test considered ?

 Non-parametric tests were performed when skewed data could not be
normalized with log-transformation.
 The observation and nutrition groups were compared with the independent
samples t test or Mann-Whitney U test for differences in baseline
characteristics and with repeated measures
 Analysis of variance for differences in outcome measures with time.
 Within each group, changes in outcome measures with time were assessed
with repeated measures analysis of variance or associated samples
Friedman test, followed by post-hoc paired t test or Wilcoxon signed
ranks for comparison with baseline values
 Energy intake and TEE were adjusted for LBM for all analyses. When
Bonferroni correction for multiple comparisons was applied,
 P values <.006 were considered for statistical significance
 P values <.05 are considered only for nominal significance.

9. Are the result clinically / sociality important ?

Ya.
10. What conclusion did the authors reach about the research question ? did they
generate new hypotheses ? Do you agree with the conclusion

Research question :
To examine whether supplemental nutrition augments the anabolic actions of
growth hormone (GH) in boys with constitutional delay of growth and maturation
(CDGM)
Conclusion
Boys with CDGM use energy at an accelerated rate, an imbalance not overcome
with added nutrition. GH therapy increases growth comparably with or without
added nutrition in these patients.
Yes, I do agree with the conclusion