In medical researches that includes human, ethics are essential part that should be sound scientifically and justified clinically.
Informed consent, communication, privacy are research elements besides respect and responsibility, and confidentiality. (6) The ethical element mentioned by the author is consent, he took an oral and written consent from the participants, Informed consent is an obligatory component, ethical and legal requirement in the research. (7) (6) Informed consent means that the participant has been informed about the aim, nature, risks, and consequences of the intended intervention and has voluntary agreed to it.(6) Informed consent must include; providing of detailed information to a subject; fully understanding of the information; expression of consent and/or authorization of the intervention. (6) where as in RCT consent is important so the participant knows what is randomization and what is done in the intervention or control group.
(2) •Sampling The sample size was 30 patients and the author have not stated the steps done to obtain the appropriate sample size but at the same time the patients were in two groups equal in size and matched age, height and body weight.-Sample size evaluated based on the predictable effect size of the intervention versus the control on the initial outcome.(2) sample size is calculated before starting a clinical study to avoid bias, in general sample size depends on:- “Acceptable level of significance” represents p value which means that we can accept the probability that the result we found is due to chance is 5%.(8)- “Power of the study” which equals (1 –?) and means that the probability of not detecting a difference when there is a difference, power of a study increases when committing type II error chances decrease.(8)- “Expected effect size” effect size represents the difference between the variable value in the control group and in the intervention group.
The estimated effect size can be taken from reported or preclinical studies conducted previously.(8) – “Underlying event rate in the population” also known as prevalence rate is important in calculating sample size, estimated from studies done previously.(8) – ” Standard deviation in the population” which measures the variability or dispersion in the data.(8)Author should described the details in establishing the sample size, since these calculations gives important information’s and indicates transparent reporting, not mentioning the calculations might predicate problems according to a study published in 2005 (9), not justifying the sample size is very common fault and has huge effect that an important therapeutic effect can be missed because of inadequate size of the study.(10)We cannot neglect that author did have equal participants in the two groups which maximize the power.(10)- The author considered the other diseases that could affect the study so he identified the inclusion and exclusion criteria to recruit eligible participants, eligibility criteria effect external validity by limiting it especially when they are strict criteria.(11) and the results will be less generalizable whereas, too board criteria will make it difficult to find a true effect of the intervention.(2)•Data collection “Reliability refers to whether an assessment instrument gives the same results each time it is used in the same setting with the same type of subjects, reliability is a part of the assessment of validity”(12)”Validity refers to how well the assessment tool actually measures the underlying outcome of interest.”(12) – HDRS: is highly valid (13) and reliable with good level of internal consistency and a higher levels of inter-rater reliability but the least reliable item is “loss of insight”.(14)- UPDRS: reliable with a high internal consistency and inter-rater reliability but with moderate construct validity.(15)
