Assignment Assessing the quality of randomized studies

 Assessment tools for randomized studies are widely available and all have problems because they do not cover all the issues that could be considered to be important. This simple method picks up on the main issues of randomization, blinding, and patient withdrawal from studies

1	Is the study randomized?  Score	1
	Yes   No	1 0
2	Is the randomization appropriate?	1
	Yes — e.g. random number tables    No — e.g. alternate patients, date of birth, or hospital number	1 0
3	Is the eligibility criteria included? (Inclusion & Exclusion)	1
	Yes No	1 0
4	Was the study double blind?	0
	Yes   No	1 0
5	Was blinding correctly carried out?	1
	Yes — e.g. double dummy    No — e.g. treatments did not look identical	1 0
6	Were withdrawals and drop-outs described?	1
	Yes	1
	No	0

 

Randomized Studies
1)    Is the study randomized? 

Yes, the study is a fully randomized study which is based on the data collected from the randomly selected research samples. In the randomized control trial, all selected research samples were belonging to the age group of 66 ± 2.

2)    Is the randomization appropriate?

Yes, the randomization process is appropriate. According to the research studies, the random selection of research samples should be free from biases. However, selected research samples should be related to the appropriate research population. In this article, samples are selected while considering the relevance of the research population with the identified research problem (see table 1 in the article). Thus, conclusively it can be said that research is randomized properly (CASTANEDA, LAYNE and MUNOZ-ORLEANS).  

3)    Is the eligibility criteria included? (Inclusion & Exclusion)

The eligibility criteria are included in the research article. According to the research article, all the patients selected for the research work must have experienced type 2 diabetes. Moreover, researchers also considered other specifications such as body composition, metabolic syndrome, abnormalities, and Glycemic control. However, some conditions are also excluded while conducting research. For instance, myocardial infarction (during the last 6 months) and instability of the chronic condition in the patients of type 2 diabetes. Although, exclusion criteria also include alcoholism, retinal hem monitoring, medical visits, dialysis and dementia.

4)    Was the study double blind? 

The study was not a double blind study. In the research article, researchers have not demonstrated any double blind process. Following information stated in the article, the research carried out a blinded fashion when they made an exception for the strength of muscles in the patients. However, there is no evidence of double-blinded fashion. 

5)    Was blinding correctly carried out? 

Yes,  blinding is correctly carried out in this research study. The research has provided authentic information about the treatment rather than looking identical.

6)    Were withdrawals and drop-outs described?

In the research article, withdrawals and drop-outs are well explained and described in the required details. Researchers have clearly stated that two subjects were not related to the research work therefore these subjects were dropped and withdrawal from the research while interpreting the results and outcomes of data analysis.

Assessing the case report:

A case report may describe an unusual etiology, disorder, differential diagnosis and unusual setting for care, information that cannot be reproduced  due to ethical reasons, unusual or puzzling clinical features, improved or unique technical procedures, unusual interactions, rare or novel adverse reactions to care, or new insight into the pathogenesis of disease.

Checklist for case report

Section	Topic	Met/unmet
General	Novelty, Patient consent, Ethical practice as per standard of care	Met
Title	Truly describe the core message of case includes the phrase “Case report”	Met
Abstract	Incorporates the core key message with necessary detail in a concise manner	Met
Introduction	Emphasizes need of publication by novelty of the case or specific adverse event	Met
Case description	Appropriate details of the case, including demography, assessment, findings, investigation and mention the intervention in detail. Dose, timing & route of drugs	Met
Discussion	Emphasizes why the case is important to medicine	Met
Conclusion	Implication of case with a core key message	Met

Case Report

1)    General: The case is on an important medical topic with novelty.  The ethical practices are considered in this case study as only limited information about the patient (case report) is presented. Any kind of sensitive information is avoided to present in the case report because of ethical considerations.

2)    Title: A Rare Case of Thyrotoxic Periodic Paralysis After Epidural Steroid Injection: A Case Report and Literature Review

3)    Abstract: According to the case study, the TPP disease is very common among the males of some Asian countries because of changing demographic conditions Although, severe hypokalemia in the young patients also concerns with the acute thyrotoxic periodic paralysis (TPP) in some rare cases only. The core message of this case study is elaborate on the factors which can have a contributing impact on the increase of this disease. 

4)    Introduction: The muscles paralysis is a common disease in the world. Such muscles paralysis can be caused by several reasons. A major reason behind the muscles paralysis is severe hypokalemia. The treatment for this kind of muscles paralysis is to correct serum potassium. However, for a safe treatment procedure, including optimal correction, safety measures, and prevention of recurrence (of the same or similar diseases to the selected one) are must require to be considered. Proper identification and analysis can prevent and control such situations in healthcare treatment services. Therefore, a medical researcher should identify novel treatment on this issue to publish and enrich literature.

5)                Case Description: The case is about the young patient having the physically collapsing at home. During the incident, the young patient did not lose his consciousness as stated by the case report. According to the case report, the diagnosis and examination process concluded that the patient had drowsy. His blood pressure and heart rate were evident to this disease as medical staff recorded 121/72 mmHg BP and 111 beats/minute of heartbeats. Upon examination, medical staff found that patient had vital signs of muscle bulk and paralysis. The patient was also having grossly intact in the cranial nerve. In this case, the patient also having diffused thyroid enlargement without any kind of stigmata thyrotoxicosis (Affram, Reddy and Osei).

6)    Discussion: Considering the increasing trend of this issue it was important to study it in detail.  Such issues of thyrotoxic periodic paralysis (TPP) can increase with the triggering factors.  Following the research findings, some triggers of this disease are exercise, high carbohydrate diets, and steroid treatment. Moreover, there were some factors which had no direct relation and association with the thyrotoxic periodic paralysis that are discussed by this case therefore it is highly important. For instance, epidural steroid injections are not directly related to the increase or control of this thyrotoxic periodic paralysis problem in the males.

The case is highly important for medicine as it explains the key reasons behind the increasing diseases. For instance, it is concluded by the literature review that such issues are critical to the gender differences and systematic effects of steroids in the patients. Additionally, such situations also sometimes cause to influence metabolism in the patients. The case is also important as it explains the relationship between thyrotoxic periodic paralysis (TPP) and epidural steroid injections. Analysis of previous literature (including research studies, patient case histories, and academic literature) conclude that thyrotoxic periodic paralysis (TPP) and epidural steroid injections are not significantly associated with each other. Therefore, change in the condition of one will not generate an impact on the condition of the second diseases. In addition, young and adult males of Asian countries have a higher chance of muscles paralysis as compared to the women who usually have a higher risk for grave disease.

7)    Conclusion of Assessing the quality of randomized studies

The whole discussion concludes that thyrotoxic periodic paralysis in a common kind of paralysis problem for the males of Asian countries. Following the case study, some issues can also increase the risk of hypokalemia. For instance, shifting potassium into the intracellular compartment in the body of a male patient. The key message of this case study identifies novel treatment for the cure of such increasing diseases in the Asian Countries.

Critical appraisal of systematic reviews

  Systematic reviews are considered to be the best level of evidence if they are well conducted and evaluate a number of randomized trials. They can be particularly useful when seeking to answer clinical questions. However, they are only reliable if the process of the review has followed rigorous scientific principles. Authors should explicitly state the topic being reviewed and have made a reasonable attempt to identify all the relevant studies.

Sl no.	Ten questions to make sense of a review  For each question answer : Yes, No, or Don’t Know
1	Are the results of the review valid?
	1 .  Did the review address a clearly focused issue (e.g. the population, intervention, and/or outcomes)? Yes 2 . Did the authors look for the appropriate sort of papers? No,       Check that the authors looked for randomized controlled trials or had clear reasons for including other types of studies. Yes
2	Is it worth continuing? 3 . Do you think the relevant important studies were included? Yes       Look for search methods, use reference list, unpublished studies and non-English language articles.
	4 . Did the authors do enough to assess the quality of the studies included? Yes         This would routinely be in the form of an assessment tool for randomized controlled trials. 5  . If the results of studies were combined, was it reasonable to do so? No
3	What are the results?
	6 . What is the overall result of the review? The research showed variable effect and how it increases risk of agitation in the critical illness. The study evaluated safety outcomes, unadjusted analysis, antipsychotics and risk biases within the considered limits.      Is there a clear numerical expression? No 7 . How precise are the results? The results are precise as the research paper included screen records, eligible articles, and qualitative synthesis.       What were the confidence intervals? Research used previously published research articles and extracted all the data and reused information provide by them therefore, the confidence interval was not mentioned by the author.
4	Will the results help my local situation? Yes
	8 . Can the results be applied locally? Yes 9 . Were all important outcomes considered? No, only significant 10. Are the benefits worth the harms and costs? Yes

=1-Are the results of the review valid?

Yes

·         Did the review address a focused issue (e.g. the population, intervention, and/or outcomes)?

Population: limited by small sample sizes and variations in different populations and agitated behaviours.

Intervention: research identified insufficient data for the recommendation of the use of agents for agitated behaviour management with the following traumatic brain injury (TBI). 

Outcome:  The research concluded that valproic acid, propranolol, methylphenidate, and olanzapine provide many benefits therefore it requires further studies to extract information. Research also concluded that antipsychotics can cause an increase in the length of PTA. The analysis of previous researches is also considered as more studies are tailored with the intervention and continuous evaluation of efficacy and safety. The continues evaluation in the studies is tailored with interventions of efficiency and safety. The research considered safety through outpatient settings, acute, rehabilitation of conditions.

·         Did the authors look for the appropriate sort of papers?

The research used a systematic review of the safety and efficacy of pharmacological agents. This behaviour of these agents in traumatic brain injury were analyzed by many types of research. Different conditions and outcomes were reported previously. In the present research Williamson et. al. (2019) conducted a systematic review of appropriate sort of papers. Researchers used most of the published work in PubMed, Embase, Ovid MEDLINE, Cochrane library, the web of science and Prospero, LILACS, and Directory of open access journals. The papers were appropriate sort of papers that published evidence of risk and benefits for the medical control of issues for traumatic brain injury. The research included randomized controlled trials, observational studies, quasi-experimental studies, and control of agitated behaviour of TBI patients. The studies include three main categories of research related to the TBI patients and these studies can be classified as three mutually exclusive symptoms including agitated behaviour without symptoms, agitated behaviour with symptoms, and safety of pharmacological interventions that can control the agitated behaviour. All the resources were equally important and analyzed to extract outcomes. the author followed all the protocols to publish the research and mentioned the resources in the study. different resources used for the data collection are listed below,

1.      HTTP:// www.crd.york.ac.uk/PROSPERO

2.      https:// www.cadth.ca/en/resources/finding-evidence-is/greymatters

2-Is it worth continuing?

·         Do you think the relevant important studies were included?

The research used preferred reporting items for systematic review and guidelines of meta-analysis. the researcher used randomized controlled, observational data, and quasi-experimental outcomes of previous researches. the case reports were excluded and observational data neglected control groups. The study includes all types of patients related to traumatic brain injury and all the relevant studies were considered in the research. The systematic review considered different behaviours of patients such as aggressive, confusing, agitation, assaultive, and irritability. The medications considered in the review were then presented to the next process that are dopamine agonist, beta-adrenergic blocker, psychostimulant, anxiolytics, hypnotics, dopamine agonists, alpha2adrenergic, and anxiolytics.  Studies also considered that if all the research items were considered in the research paper by the previous author or not. The comparison is important to find the difference and benefits of researches. the behaviour studies in the research enabled investigators to compare a medication to placebo and other combinations of medications. The primary research outcomes defined reduction in the severity of agitated behaviour that was measured in the study. Based on the feasibility the report provides resolution for the severity of agitated behaviour. The research also considered duration, inattention, symptoms, aggressiveness, hallucination,  inappropriate mood, disorientation, and inappropriate speech of the patient suffering from traumatic brain injury. The types of symptoms included in the research were limited to conditions. The primary research measured these parameters and secondary research measured lengths of stay in intensive care units, adverse events, hospital LOS, cardiac arrhythmias, extrapyramidal effects, seizures, physical restraints, functional outcomes, cognitive outcomes, hypotension and discharge of the patient from the hospital. The patient involvement in the research was not limited to these conditions but research design developed and interpreted the results. The patients in the research were not considered and they had no comments on the study design and outcomes. The validation of research is only limited to the comparison with previously published work. Since the patients were not invited to contribute, edit and write the documents and data therefore, research validations are limited.

·         Did the authors do enough to assess the quality of the studies included?

The author used 181 articles and accessed their information and also used measured information from 21 studies. In the research, the author suggested different potential benefits such as the use of propranolol that reduce maximum intensities of agitation per week, use of physical restraints, how methylphenidate improve anger measures and results from the 6-week assessment of patients. Data collected from the 6-week assessment provided information about the treatment process, use of valproic acid, behavioural ratings on a scale, and how olanzapine reduce irritability. In the initial three weeks, the research only considered effective treatment strategies. The studies used in research measured safety outcomes, duration of post-traumatic brain injury and risk bias limitations.  

·         If the results of the studies were combined, was it reasonable to do so?

No combined

The study used different investigation parameter and compared medication to placebo, combinations of medications, and a combination of medication to another medication. Under the assessment protocol of traumatic brain injury, the researchers used a combination of clinical measures, cognition, and orientation. In the review, the comparative studies assessed the efficacy of tricyclic antidepressants, benzodiazepines, and dexmedetomidine. The research combined different clinical trials that revealed ongoing study combinations of quinidine and dextromethorphan.

3-What are the results?

In the research, the research assessed 181 articles and 21 studies. The studies used in the review suggested different possibilities to overcome the issue and how it can be reduced. Some of the selected studies in the review suggest possible solutions such as the use of propranolol, methylphenidate, and valproic acid. The benefits of these methods were previously studied by the research and these benefits define that propranolol can be used to reduce maximum intensities of agitation per week and induce impact on the physical restraints.

-What is the overall result of the review?

The review concluded that data is not sufficient to recommend the use of any agent in case of TBI

 What were the confidence intervals?

  NO

-Can the results be applied locally?

Yes

-Were all important outcomes considered?

No

-Are the benefits worth the harms and costs?

Yes

References of Assessing the quality of randomized studies

Affram, Kwame Ofori, Tanya Luke Reddy and Kofi M. Osei. "A Rare Case of Thyrotoxic Periodic Paralysis After Epidural Steroid Injection: A Case Report and Literature Review." American Journal of Case Reports 19 (2018): 1453-1458.

CASTANEDA, CARMEN, et al. "A Randomized Controlled Trial of Resistance Exercise Training to Improve Glycemic Control in Older Adults With Type 2 Diabetes." DIABETES CARE 25.12 (2002): 2335-2341.

=References