Author(s)

Chipps, E.M., Carr, M., Kearney, R., MacDermott, J., Von Visger, T., Calvitti, K., Vermillion, B., Weber, M.L., Newton, C., St Clair, J. and Harper, D

Title

Outcomes of an Oral Care Protocol in Post-mechanically Ventilated Patients

Journal

Worldviews on Evidence‐Based Nursing,

Year 2016

Volume13

Issue 2

Pg. #102-111

Location(s)/Setting(s)

large academic medical center in the Midwestern United States

Concepts

(1) Measures of oral health, (2) Rate of oral colonization with methicillin-sensitive SA (MSSA) and MRSA, and (3) Patient satisfaction with in-hospital oral care.

Intervention/Independent Variable

oral care protocol for hospitalized patients

Dependent Variable(s)

health outcomes in recently intubated patients

Controlled Variable(s)

Post-mechanically Ventilated Patients

Specific Design

Randomized controlled trial

Blinded? 

☒ Yes 

☐ No

Description of Intervention

To develop an evidence-based oral care protocol for hospitalized patients and determine the impact of this protocol on health outcomes in recently extubated patient

Comparison group(s)

None

Size

74 randomized subjects

Sampling Method

randomized controlled trial,

Sample Characteristics

Post-mechanically Ventilated Patients

Description of measures

As measured by the R-THROAT, oral cavity health improved over time in both groups, but the intervention group demonstrated significantly more improvement than the control group (R-THROAT score improved by 1.97 intervention vs. 0.87 control; p = .04). Two categories, tongue and mouth comfort, demonstrated the most significant improvement

Data quality

The revised THROAT (R-THROAT; oral cavity assessment) was used to ascertain the quality of data gathered

Title

Is the title clear enough to identify the key phenomenon and group or community under study?

The title of the article “effect of  an oral care protocol in post-mechanically ventilated patients is clear enough to identify the key concepts and target group under evaluation in the study (Chipps et al., 2016).

Abstract

Does the abstract clearly summarize the main features of the report?

The abstract clearly highlights and summarizes the main features discussed in the study.

Introduction

Statement of problem

• Is the problem easy to identify? 
• Is it significant for nursing?
• Is the research design appropriate for the problem?
• Is there a clear need for the study?

The problem being evaluated in the study-effect of  an oral care protocol in post-mechanically ventilated patients is clear and significant for the nursing practice. 

The research design –randomized controlled trials is appropriate for the research and clearly states its need for the study.

Hypotheses or research questions

• Are the questions or hypotheses explicitly stated? If not, is their absence explained?
• Can you easily identify the variables the way the questions or hypotheses are worded?

The research hypothesis are clearly explicitly stated i.e. to (1) Measures of oral health, (2) Rate of oral colonization with methicillin-sensitive SA (MSSA) and MRSA, and (3) Patient satisfaction with in-hospital oral care (Chipps et al., 2016).

Dependent, independent and controlled research variables can be easily identified based on the way the research questions, aims and hypotheses are worded. 

Literature Review

• Is the literature review up-to-date and based mostly on primary sources?
• Did the review adequately summarize the evidence?
• Does the literature review make it clear there is a need for a study of this kind?

The literature review up-to-date since sources used is within 10years and based mostly on primary sources. 

The literature review has adequately summarized the appropriate evidence about the nature and stages used in the study (Chipps et al., 2016).

The researchers holds that future should include exploring oral care protocols in edentulous patients and expanding the number of pathogenic organisms that are evaluated 

Conceptual/theoretical framework

• Is the conceptual or theoretical frame clearly identified?

The conceptual or theoretical frame clearly identified and described

Method

Protection of human rights

• Were rights of the study participants protected?
• Was the study externally reviewed by an IRB or ethics review board?
• Was the study clearly designed to minimize risks and maximize benefits to the participants?

Participants were required to have a minimum of three teeth and be able to provide informed consent, either directly or through a legally authorized representative. The study protocol was approved by The Ohio State University Institutional Review Board (FWA #00006378).

Patients were excluded if they had an allergy to products or components of the oral care protocol or a history of oral or facial surgery or trauma in the 3 months prior to enrollment. This was meant to reduce risks and increase benefits to the participants (Chipps et al., 2016).

Research Design

• Was the most rigorous design used given the purpose of the study?
• Was the number of data collection points appropriate?
• Did the design minimize biases and threats to study validity by using blinding and minimizing attrition?

Independent Student’s t tests, chi-square, and Fisher’s exact tests were used to summarize and compare the usual care and intervention groups on age, gender, race, baseline R-THROAT, and culture result. The number of data points was appropriate and validity was ensured through the use of THROAT- a valid and reliable instrument to assess the oral cavity score weighted kappa.

Population and sample

• Was the population identified?
• Was the sample described in adequate detail?
• Were sampling biases minimized?
• Was the sample size adequate?

Study participants were recruited from 4 ICUs, including a 44-bed surgical ICU, a 25-bed medical ICU, a 14-bed medical ICU, and 30-bed cardiac surgical unit (Chipps et al., 2016). Patients were eligible to be enrolled if they were mechanically ventilated for at least 48 hours and being considered for ventilator liberation (criteria PEEP 8 and FiO2 50%) or had been recently extubated. This approach minimized sampling biasness and ensured that the sample size was adequate for the research.   

Data collection and measurement

• Were key variables measured using an appropriate method (interviews, observations, etc.)?
• Were the instruments identified?
• Did the report provide evidence that the methods were reliable, valid, and responsive?

Clinical observations were made as a way of ensuring that the key variables were measured using the appropriate method. 

R-THROAT and oral cavity assessment were conducted as instruments of data collection and ascertained that the methods were reliable, valid and responsive to the research problem. 

Procedures

• If there was an intervention, was it well described?
• Did most of the participants allocated to the intervention group actually receive it?
• Was data collected in a non-bias manner?
• Were the individuals collecting data appropriately trained so they did not impact the results?

The intervention included a 4-day systematic oral hygiene program provided to patients who were post-extubation using the products like toothpaste, toothbrush, flossing, tongue care, mouth rinse and lip care (Chipps et al., 2016).

All participants allocated to the intervention group actually receive it

Data was gathered in a non-biased manner given that it was a randomized controlled.

Individuals who collected data were properly trained as they were professionals with vast experience in oral health. 

Bivariate (e.g., t-test, ANOVA, Pearson’s r)

Independent Student’s t tests, chi-square, and Fisher’s exact tests

Multivariate (e.g., multiple regression, logistic regression)

R-THROAT

Summary of study main points and learnings 

• What is the effect size?
• Is the study statistically significant?
• Is the study clinically significant?
• What are the recommendations for future studies?

Evidence supporting an oral care protocol in the intubated patient has been well substantiated. However, there has been little or no discussion in the literature about the oral care provided to patients immediately post-intubation (Chipps et al., 2016).

The study’s findings suggest that attention to the oral care of the post-mechanically intubated patients is an important component of care and merits further attention. This implies that the study was clinically and statistically significant.

Future research should include exploring oral care protocols in edentulous patients and expanding the number of pathogenic organisms that are evaluated