Statistical Analysis on Clinical Trial

This article reviews scientific papers based on viscosupplementation via using hyaluronic acid (HA) with specific highlight over the safety, efficacy and patient-acceptability. The study aims to determine the safety and efficiency of intraarticular HA injection with respect to placebo injection for pain relief and nonoperative treatments to treat joint osteoarthritis. The paper followed systematic review format. The selected papers are based on the inclusion criteria (majorly the papers which performed meta-analysis) who worked on the HA injection of OA patients.

Running head: STATISTICAL ANALYSIS ON CLINICAL TRIAL
Statistical Analysis on Clinical Trial
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STATISTICAL ANALYSIS ON CLINICAL TRIAL
Table of Contents
Introduction and Background:....................................................................................................3
PICO question:...........................................................................................................................3
Journal article:............................................................................................................................3
Study Purpose:-..........................................................................................................................3
Rationale of the Research:-........................................................................................................4
Description of how it meets the inclusion criteria:-...................................................................4
Research Question of the study:-...............................................................................................4
Does the study’s research question (PICO) match your question PICO?..................................4
Research Design:-......................................................................................................................5
Randomized assignment of patients to treatments.................................................................5
Detection of similarity of groups at the start of the trial........................................................5
Whether group were treated equally aside from the allocated treatment...............................5
Sampling Methods:-...................................................................................................................5
Blinding:-...............................................................................................................................5
Description of Samples:-............................................................................................................5
Research Methodology:-............................................................................................................6
Subject Mortality:-.....................................................................................................................6
Treatment Effect:-......................................................................................................................6
Power or Effect Size of the study adequate:-.............................................................................6
Statistical methods used for data analysis:-...............................................................................6

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STATISTICAL ANALYSIS ON CLINICAL TRIAL
Study results:-.............................................................................................................................7
Study limitations:-......................................................................................................................7
Significance of the clinical result:-............................................................................................7
References..................................................................................................................................8

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STATISTICAL ANALYSIS ON CLINICAL TRIAL
Introduction and Background:
Osteoarthritis is defined as a chronic disease that causes significant joint pain. This
progressive disease also leads to loss of work time and reduce performance in work. The
major risk factors for the development of the disease are age and obesity. The main target
group of the disease is elderly population (Loeser et al., 2012).
Complete cure of the disease can only be achieved via prosthethic knee treatment (Juhl et
al., 2014). Other onon-operative measures of treatment include physiotherapy, pain killers
and life style modification. For osteoarthritis of knees, intra-articular injection such as
corticosteroids, visco-supplements with hyaluronic acid (HA) are regarded as the final
modality of non-operative (Kizhedath et al., 2017). However, the safety and the efficacy of
the use intraarticular injection of HA still lack significant scientific data.
PICO question:
Does intra-articular injection of Hyaluronic acid give more clinical efficacy than
standard corticosteroid injection in managing patients with major joint osteoarthritis?
Journal article:
McArthur, B. A., Dy, C. J., Fabricant, P. D., & Della Valle, A. G. (2012). Long term safety,
efficacy, and patient acceptability of hyaluronic acid injection in patients with painful
osteoarthritis of the knee. Patient preference and adherence, 6, 905.

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STATISTICAL ANALYSIS ON CLINICAL TRIAL
Study Purpose:-
The aim of this article is to review scientific papers that are based on
viscosupplementation via using hyaluronic acid (HA) with specific highlight over the safety,
efficacy and patient-acceptability.
Rationale of the Research:-
This article must be included for future analysis in Capstone project, as it gives a
detailed overview of the efficacy of treatment of OA via viscosupplementation through
successful implementation of HA.
Description of how it meets the inclusion criteria:-
The current study satisfied all inclusion criteria. This peered reviewed journal paper
that was published in the year 2012 and follows a systematic review approach. The
systematic review was done via citing articles which have sample size of more than 30 and
the age bar was set above 18-year. Moreover, the systematic review is mostly oriented
towards intraarticular injection of HA for viscosupplementation.
Research Question of the study:-
The major question is to determine the safety and efficiency of intraarticular HA
injection with respect to placebo injection for pain relief and nonoperative treatments to treat
joint osteoarthritis.
Does the study’s research question (PICO) match your question PICO?
The research appropriately satisfies the identified PICO question but fail to identify
all the queries of the PICO questions. Like in order to test the efficacy, the paper has only
targeted patient who are above 60-year.

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STATISTICAL ANALYSIS ON CLINICAL TRIAL
Research Design:-
Randomized assignment of patients to treatments
The method of the selection of articles indicates that the review papers were selected
randomly. However, the researchers carried out an unblended study that is not favourable for
randomized clinical trials.
Detection of similarity of groups at the start of the trial
There is a graph providing a comparative overview of the effect size and the time-
point week in regards to HA injection. However, there was no similarity of groups at the
initiation of the systematic-review.
Whether group were treated equally aside from the allocated treatment
Each selected groups for each portion of the study are different.
Sampling Methods:-
Conditional and stratified randomization was used in this study.
Blinding:-
Since it was a systematic review the concept of blinding is irrelevant in this case.
Description of Samples:-
The literature papers that where were selected for the study of the efficacy of HA
mostly covered samples between the age group of 60 to 64 years or above 65 years.

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STATISTICAL ANALYSIS ON CLINICAL TRIAL
Research Methodology:-
The paper followed systematic review format. The selected papers are based on the
inclusion criteria (majorly the papers which performed meta-analysis) who worked on the HA
injection of OA patients.
Subject Mortality:-
The subject mortality is insignificant as it is a systematic review of randomized
controlled trials to the patients with joint osteoarthritis (OA) in which IA HA dose was
compared with the placebo who were given normal pain killers.
Treatment Effect:-
Treatment affects on efficacy showed patients who are above 65 years of age and
suffering from complete loss of joint space and more likely to respond to the treatment of
viscosupplementation than that of the younger population with more moderate disease. The
systematic review also elucidated that viscosupplementation is more effective for the OA of
the knees when given over a period of 5 to 13 weeks.
Power or Effect Size of the study adequate:-
Power or the effect size of the study was not adequate at different meta-analysis
targeted in this systematic review has different sample size, age group and different form of
OA in different location.
Statistical methods used for data analysis:-
No statistical method was use for the data analysis as it was a systematic review. At
the end of the paper, there is statistical data representation of the study performed by the
Bannuru et al., 2011.

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STATISTICAL ANALYSIS ON CLINICAL TRIAL
Study results:-
The systematic review showed that viscosupplementation with intraarticular HA has
high levels of clinical efficacy and fovourable safe profile in order to provide a temporary
relief from the pain of OA.
Study limitations:-
The main limitations of the study is, its systematic review did not included the paper
which tested the safety and efficacy of the treatment of the viscosupplementation with
intraarticular HA over the pregnancy women.
Significance of the clinical result:-
The results obtained from the study is significant however, there were less highlight
over the statistical reports of the selected papers.

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STATISTICAL ANALYSIS ON CLINICAL TRIAL
References
Bannuru, R. R., Natov, N. S., Dasi, U. R., Schmid, C. H., & McAlindon, T. E. (2011).
Therapeutic trajectory following intra-articular hyaluronic acid injection in knee
osteoarthritis–meta-analysis. Osteoarthritis and Cartilage, 19(6), 611-619.
Juhl, C., Christensen, R., Roos, E. M., Zhang, W., & Lund, H. (2014). Impact of Exercise
Type and Dose on Pain and Disability in Knee Osteoarthritis: A Systematic Review
and Meta‐Regression Analysis of Randomized Controlled Trials. Arthritis &
rheumatology, 66(3), 622-636.
Kizhedath, S., Abboobacker, H. K., Valoth, G., & Vasudevan, B. (2017). Comparative study
of intra-articular hyaluronic acid and intra-articular triamcinolone hexacetonide in
primary osteoarthritis of knee. Journal of Evolution of Medical and Dental Sciences,
6(50), 3841-3847.
Loeser, R. F., Goldring, S. R., Scanzello, C. R., & Goldring, M. B. (2012). Osteoarthritis: a
disease of the joint as an organ. Arthritis & Rheumatology, 64(6), 1697-1707.