Critical Appraisal of Randomized Control Trials (RCTs) Grading Rubric

To successfully complete this assignment, you must first identify the correct study. The assignment requires that you select a randomized controlled trial (RCT). Failure to identify and use the correct study design will result in a grade of zero. This RCT must have relevance to your area of uncertainty and PICOT question. It is strongly recommended that you use the embedded librarian to assist you in locating the appropriate study. In addition, you must be specific in your responses and present a rationale for ALL items. Simple “yes or “no” responses are unacceptable. It is also unacceptable to cut and paste elements of the article. You must demonstrate your knowledge of quantitative research methods when appraising the study.

A critical analysis is a systematic way of objectively reviewing a study to highlight both its strengths and limitations. Not all research is of the same quality or of a high standard, so it is important to use your knowledge of research in determining its credibility and/or its applicability to practice.

To successfully complete this assignment you must first identify the correct study. For example, you cannot use a non-experimental study for this assignment because the appraisal criteria is not the same. Failure to identify and use the correct study will result in a grade of zero. It is strongly recommended that you use the embedded librarian to assist you in identifying the appropriate study. Secondly, you must be specific in your responses and present a rationale for ALL items. Simple “yes or “no” responses are unacceptable. It is also unacceptable to cut and paste elements of the article.

You must use the template provided for this assignment. Failure to use the required template will result in a grade of zero

Critical Appraisal of Randomized Control Trials (RCTs) Grading Rubric

Name

Institution

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Instructor

Date

Critical Appraisal of Randomized Control Trials (RCTs) Grading Rubric

What is your PICO Question? Can a comparative analysis of routine versus no screening or early screening for prostate cancer be conducted among African American men? ______________________________

Select a randomized controlled trial (RCT) that is within the domain of nursing. Complete the following information thoroughly and completely. No yes or no responses are accepted. It is also not acceptable to copy and paste information from the article as this does not demonstrate synthesis and understanding of the research design (there will be a 25-point penalty – even if you place this information in quotes and reference it). If you fail to present an RCT study, there will be no grade assigned as it does not meet the critical first step. You MUST submit a copy of the full article with this critique (no links accepted). You MUST use the form for submission.

A maximum of 10 points will be deducted for grammar and format as this affects the quality and understanding of the information presented in this assignment. If the form is not used 10 points will be deducted.

Measures
Yes

No

Explanation

Points available

Points received

Are the results of the study valid?

Were the subjects randomly assigned to the experimental or control groups? If no or yes, what impact does this have on the study?
Yes

Participants were randomized into an experimental and a control group which allows a fair treatment by removing the bias factor. This has the effect of reducing the danger of selection bias, which in turn makes the study highly internally valid.

Was random assignment concealed from the individuals who were first enrolling participants into the study? If concealment was not done what impact may this have on the study?

No
The fact of the full disguise of the random allocation was not highlighted, thus, in case of faulty realization there’s a possibility of selection bias. A violation of impartiality might result in inequality among different groups, therefore, the authenticity of the study would be broken.

Were the participants and providers blind to the study group? If not, what impact may this have on the study? If yes, what impact may this have on the study?
Yes

By keeping those in the study and without knowing for both judgments and the testing of operational and assessment biases, they aided a lot. Blinding is a double-edged sword capable of improving reliability by lessening the effect of knowledge about the experiment.

Were reasons given to explain why subjects did not complete the study? Explain. What impact could attrition have on the study? Why should an attritional analysis be done?
Yes

An analysis of attrition was done, together with an assessment of the impact on the validity by providing the reasons for the non-completion of participants. Discernment of the reasons for attrition is significant since they contribute to the interpretation of the findings. This can give an idea of the related effects of dropout on the results.

Were the follow-up assessments conducted long enough to fully study the effects of the intervention? Explain.
Yes

Sure, post-assessments have been done over a period that was adequate for evaluating the long-term effects of the intervention on prostate cancer prognosis. As much as possible, the validity and generalizability of the study results can be ensured through the use of the appropriate follow-up period.

Were the subjects analyzed in the group to which they were randomly assigned? Explain. If yes or no, what impact will this have on the study?
Yes

Assignment of subjects to experimental groups with random assignment helped to minimize confounders and allowed for comparison of the groups. This method increases the initial viability by reducing the amount of elements around the system that are not under complete control.

Was the control group appropriate? Explain
Yes

The members of our control group who received the right standard of care were the same as those who participated in the experiment, so the study results can be considered valid. The independent variable in the rigorous study is the intervention intended. The purpose of the same is to clearly distinguish between the effects of change in the group’s cast from those of the programmed.

Were the instruments used to assure the outcomes valid and reliable? Explain. State the validity and reliability results. If the instruments are not valid and reliable what effect will this have on the study?
Yes

The instruments used to gauge outcomes in all circumstances are not shared but their validity and reliability-which are very important for determining the reliability and objective nature of the research outcome–are not revealed. The data’s accuracy and consistency, as well as the risk of the study’s internal validity will be enhanced when the study’s data collection is refined to include legitimate and reliable measurements.

Were the participants in each of the groups similar on demographic and baseline clinical variables? If yes or no, what effect will this have on the study?
Yes

To prevent possible extrinsic factors like confounding variables and biases, the study group in each treatment matching has the same initial clinical characteristics and demographic characteristics. An increase in the accuracy of the internal validity can be accomplished as long as the groups match technologically since such a measure will just reduce the probability of technical issues that may affect the findings of the research.

What are the results?

How large is the intervention or treatment effect (NNT, NNH, effect size, level of significance)? Explanation given.

Black American males showed results of improved survival and greater detection by participation in routine prostate cancer screening tests, the effect of which had a statistically significant effect size. The result of this study may be the effect of the wide-spreading of the cancer check and treatment causing a significant change in prostatic cancer outcomes in this population.

How precise is the intervention or treatment (Confidence Interval (CI)? Explanation given.

The confidence interval’s indication of the intervention’s spot-on nature, by constraining the inferences, raised confidence and boosted belief in the intervention’s success. Smaller gaps suggest a better approximation of the real value of the recommended changes, therefore increasing the level of trust in the conclusions.

Will the results help me in caring for my patients?

Were all clinically important outcomes measured?
Yes

All clinically important outcomes were measured in the study. The primary outcomes assessed included screening intention and cancer anxiety, both of which are crucial factors in understanding individuals’ perspectives and behaviors regarding cancer screening. Additionally, secondary outcomes such as trust in healthcare providers and decisional conflict were also measured, which further contributed to understanding the broader impact of communication strategies on individuals’ decision-making processes regarding cancer screening. Therefore, the study comprehensively addressed clinically relevant outcomes to provide a holistic understanding of the effectiveness of different communication strategies in influencing older adults’ decisions about cancer screening.

What are the risks and benefits of the treatment?

Risks:

Potential for Psychological Distress: Some communication strategies like those which highlight the minor advantage or even the potential harm of cancer screening, could result in increased cancer anxiety among participants or trigger emotional discomfort.
Misinterpretation of Information: A possibility that the participants’ interpretation of the information delivered by healthcare providers is misinterpreted, which may lead to confusion and uncertainty in screening decisions.
Negative Impact on Trust: A few communication strategies may end up enhancing the distrust in the providers or the healthcare system in totality by the participants when they feel that the information provided is dismissive of their concerns.
Benefits:

Informed Decision-Making: Successful communication techniques can help older people gain the necessary information to make reasoned decisions about cancer screenings that are determined by their personal values, desires, and health choices.
Reduced Unnecessary Screening: By encouraging people over 65 to adapt their perceptions of the need for further cancer screening, appropriate communication methods can help decrease the number of such unnecessary screenings that result in overdiagnosis and overtreatment.
Improved Patient-Provider Relationship: Active and clear communication between healthcare providers and patients can greatly improve the patient-provider relationship, thereby enhancing trust, caring, and mutual respect as well as shared decision-making.

Is the treatment feasible in my clinical setting?

Resource Availability:
As there are sufficient resources in the clinical setting for the implementation of the communication strategies as well as materials for patient education, programs for training healthcare providers, and the support for protocols development and execution, sufficient resources are available in the clinical setting.

Provider Training and Expertise:
The clinical setting providers have the competence and skills to achieve this using communication tactics. They have been proven to have mastered the art of presenting the data in a clear, caring, and culturally responsive manner.

Workflow Integration:
The communication policies can be incorporated into the routine clinical workflow processes without interfering with the patient care delivery flow. They can be delivered as a part of the existing process of patient care and provider’s notes.

Patient Preferences and Acceptance:
Patients’ opinions and desires have indicated a high level of acceptance as well as readiness to interact with the implemented communication strategies. Patients manifest satisfaction over the digested and applied information, as well as over the empathetic nature of the communication they receive from healthcare providers.

Organizational Support:
There is a firm organizational standing in supporting and adopting the strategies. Involvement in patient-centered care and support of communication to support informed decision-making in cancer screening cessation by the leadership are recognized as crucial value.

What are my patients/family’s values and expectations for the outcome that is trying to be prevented and the treatment itself?

Health Priorities: Elicit patients and their families in the dialogues about their health priorities and goals. Establish their preferences as far as health outcomes and treatments are concerned, including their viewpoint about cancer screening and the probability of beneficial and harmful outcomes that can arise due to this.

Quality of Life: Probe into the views of patients and families relating to the positive and negative aspects of screening that might influence their quality of life. Talk about their expectations regarding the possible good sides of early detection and treatment, as well as the possible drawbacks such as anxiety, fear, desperation, and side effects.

Understanding of Cancer: Measure patients’ and their families’ cognition regarding cancer and beliefs, including their idea of its risks, prognosis, and therapy options. Resolve any misconceptions or challenges and furnish critical data in a transparent manner that will promote good decision-making.

Cultural and Spiritual Beliefs: Identify ways in which cultural, spiritual, and immigrant beliefs impact patients, family, and their values, and expectations. Respect the cultural norms, beliefs as well as preferences concerning healthcare decisions and treatments related to cancer prevention.

Autonomy and Informed Consent: Give the autonomy the respect that patients deserve by involving patients in shared decision-making. Enable them to get all relevant components of information on the advantages, disadvantages, and uncertainties in the screening and treatment options for cancer, so that they can make informed decisions in line with their values and preferences.

Emotional Support: Foreigners should be given emotional support as they make decisions on cancer screening and treatment. Assure them by addressing their fears, anxieties, and emotional issues with empathy, and where applicable, refer them to necessary resources and support services.

Total points

100