Randomized Controlled and Clinical Trials (RCTs)

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Results and Validity

Randomized controlled (or clinical) trials (RCTs) are experimental studies that randomly assign subjects to groups, one of which acts as experimental and the other one serves as a control group. Even though RCTs are more characteristic to medical literature, nursing may also benefit from such studies. Large and diverse sample sizes, as well as high internal validity, may be noted as the key advantages of RCTs. Due to the above issues, a researcher may come up with credible conclusions and provide a plan for their implementation and successful use in practice.

In their systematic review (SR), Jackson et al. (2013) explored the role of patient-centered care in medical homes. The search for randomized-controlled trials (RCTs) was made to collect the most credible data published within recent years. The search strategy is rather detailed and transparent since the authors outline the number of initial articles and those that were selected after meeting inclusion criteria. In particular, 19 studies focusing on patient-centered medical homes (PCMHs) were selected based on their moderate strength of evidence and results that are important to nursing practices. Among validity identification tools, the authors distinguished random assignments to studying groups, patient experiences and health outcomes, as well as nurses’ attitudes.

In spite of the fact that the same credibility criteria were applied to all studies that might be potentially included in the sample size, the results across articles were not consistent. It may be explained by different aims stated by researchers in their studies: while some of them targeted the investigation of patient outcomes, others were aimed at determining factors affecting PCMH effectiveness. It should be stressed that this systematic review involves only peer-reviewed articles that present both aggregate and individual patient data, which shows the wide coverage area identified by the authors (Melnyk & Fineout-Overholt, 2011). In addition, such an approach allows considering various contexts and health issues that may also impact inpatient health care services in terms of patient-centered care approach.

The given SR also provided statistical information on how the results were received, processed, and interpreted. Information regarding the target population, interventions, financial aspects, risk of bias, etc. were collected. If odds ratios (ORs) were not identified in this systematic review, then the authors outline relative risk ratios (RRs) for each of the articles selected. Accordingly, effect sizes were highlighted for every study based on statistical calculations. One may evaluate the evidence given by the mentioned study as level I since it is based on a synthesis of data obtained from RCTs (Fineout-Overholt, Melnyk, Stillwell, & Williamson, 2010a).

Aligning My Patients with the Given Systematic Review

In my opinion, my patients are similar to those included in the systematic review that was discussed above. The key similarity is associated with the fact that my experience shows that patients need to trust their nurses to be sure that they would receive the most appropriate care. The findings provided by the authors of the article under discussion are feasible, and they can be implemented based on human resources and relevant equipment, as assumed by Fineout-Overholt, Melnyk, Stillwell, and Williamson (2010b). Limitations and risks to the identified results are also outlined, which would help to apply them in practice. My clinical assessment of a patient is that the assistance should be aligned with his or her individual preferences, needs, and values while making clinical decisions. Among factors that may impede the process of implementing the findings, one may enumerate concomitant diseases, chronic conditions, specific patient needs, etc. It is worth noting the fact that most researchers focus their attention on a specialist who provides medical care, paying little attention to a patient who is also involved in the communication process. The importance of such characteristics as a trust to a doctor and a nurse refers to critical factors, contributing to adherence to treatment and greater chances of successful recovery. The attitudes of my patients are positive since patient-centeredness means closer attention to a patient and his or her family.

New Task (Questions to an RCT study)

In their peer-reviewed article, Denig, Schuling, Haaijer-Ruskamp, and Voorham (2014) clearly state the aim of their work is to evaluate the effects of patient-centered care compared to the traditional approach in prioritizing treatment objectives in patients with diabetes. Among the inclusion criteria, there were type II diabetes, age up to 65 years, and inpatient care settings. Myocardial infarction, dementia, terminal illnesses, blindness, cognitive deficits, and the inability to read Dutch were determined as the exclusion criteria. The participants were randomly assigned either control or experimental groups to ensure the appropriateness of the study. In particular, 225 respondents were involved in the intervention group, and 119 to the second group based on the practice consultation preceded by the review of electronic medical records of potential participants and random allocation. The representatives of both groups were comparable in terms of sex, education, and age.

The participants, researchers, and healthcare professionals engaged in this RCT study were blinded to the intervention. The predefined computer algorithm supported by a blockwise scheme was utilized to withhold the results of the allocation process, thus making sure that randomization terms were strictly followed. The intervention used in the given study is associated with the decision aid elaborated specifically for an individual patient in order to present risks and treatment options in a graphical format. To facilitate patient-provider interaction and patient-oriented care, such modifying factors as the age and educational levels were implemented in the electronic medical record system. In addition to the above intervention, the report states that the control group members received usual care and follow-ups. The findings of the study showed no significant difference in empowerment in intervention and control groups, yet it was noted that the aid system was not used fully. The clinical relevance of the mentioned outcomes outlines the need for enhancing the suggested decision aid and conducting further research.

Reference

Denig, P., Schuling, J., Haaijer-Ruskamp, F., & Voorham, J. (2014). Effects of a patient oriented decision aid for prioritising treatment goals in diabetes: Pragmatic randomised controlled trial. The BMJ, 349, 1-14.

Fineout-Overholt, E., Melnyk, B. M., Stillwell, S. B., & Williamson, K. M. (2010a). Evidence-based practice step by step: Critical appraisal of the evidence: Part I. American Journal of Nursing, 110(7), 47-52.

Fineout-Overholt, E., Melnyk, B. M., Stillwell, S. B., & Williamson, K. M. (2010b). Evidence-based practice, step by step: Critical appraisal of the evidence: Part II: Digging deeper—examining the” keeper” studies. American Journal of Nursing, 110(9), 41-48.

Jackson, G. L., Powers, B. J., Chatterjee, R., Bettger, J. P., Kemper, A. R., Hasselblad, V.,… Gray, R. (2013). The patient-centered medical home: A systematic review. Annals of Internal Medicine, 158(3), 169-178.

Melnyk, B. M., & Fineout-Overholt, E. (Eds.). (2011). Evidence-based practice in nursing & healthcare: A guide to best practice. Philadelphia, PA: Lippincott Williams & Wilkins.

Appendix

1. Are the Results of the Review Valid?

A. Are the studies contained in the review randomized controlled trials?	Yes	No
B. Does the review include a detailed description of the search strategy to find all relevant studies?	Yes	No
C. Does the review describe how validity of the individual studies was assessed (e.g., methodological quality, including the use of random assignment to study groups and complete follow-up of the subjects)?	Yes	No
D. Were the results consistent across studies?	Yes	No
E. Were individual patient data or aggregate data used in the analysis? both	Yes	No

2. What Were the Results?

A. How large is the intervention or treatment effect (OR, RR, effect size, level of significance)?	OR – unknown, RR- specific for every study, effect sizes –presented for each of the studies, I level significance
B. How precise is the intervention or treatment (CI)?	wide

3. Will the Results Assist Me in Caring for My patients?

A. Are my patients similar to the ones included in the review?	Yes	No
B. Is it feasible to implement the findings in my practice setting?	Yes	No
C. Were all clinically important outcomes considered, including risks and benefits of the treatment?	Yes	No
D. What is my clinical assessment of the patient and are there any contraindications or circumstances that would inhibit me from implementing the treatment? concomitant diseases, chronic conditions, specific patient needs, etc.	Yes	No
E. What are my patient’s and his or her family’s preferences and values about the treatment that is under consideration? positive since patient-centeredness means closer attention to a patient and his or her family	Yes	No

Table 1. Rapid critical appraisal checklist for systematic reviews of clinical intervention studies.