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You are required to critique the article “Elahi M, Mansouri P, Khademian Z. The effect of education based on human care theory on caring behaviors and job involvement of nurses in intensive care units. Iranian J Nursing Midwifery Res 2021; 26:425‐9”.  

The critique of the article should be based on the NICE guidelines, in your own words in the following areas:

1. Method of allocation to intervention and comparisons 

2. Outcomes 

Note:

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C. You may choose to either submit the critique in typed format or you may handwrite and scan the document. 

© 2021 Iranian Journal of Nursing and Midwifery Research | Published by Wolters Kluwer – Medknow 425

Introduction
Nursing care behavior is an act, conduct,
and trait enacted by professional nurses,
which provide care, protection, and
attention to the patient.[1] Caring behaviors
can improve the quality of care, leading
to a sense of security, less anxiety, and
an agreement between caregivers and
patients, which subsequently enhances
patient satisfaction.[2] Nurses reported that
providing caring behaviors enabled them
to have a better understanding of patients’
conditions.[3] Most of the caring behaviors
are classified into two main components,
expressive and instrumental components.
Instrumental behaviors are related to
technical and physical behaviors, while
expressive behaviors are psychological and
emotional.[4,5]

Watson’s theory of human care offers clear
guidelines for nurse–patient interactions.[6]
This theory is applicable in clinical care
units that provide critical care for patients,

Address for correspondence:
Ms. Parisa Mansouri,
Department of Nursing,
Fatemeh Nursing and Midwifery
School, Shiraz University of
Medical Sciences,
P.O. Box: 71345‑1359,
Shiraz, Iran.
E‑mail: [email protected]

Access this article online

Website: www.ijnmrjournal.net

DOI: 10.4103/ijnmr.IJNMR_43_20
Quick Response Code:

Abstract
Background: Caring is the essence of nursing, and nurses who are dissatisfied with their job are
not able to perform optimal patient care. This study was conducted with the aim to determine the
effect of education based on human care theory on nurses’ caring behaviors and job involvement.
Materials and Methods: In this clinical trial, a total of 110 intensive care unit nurses from Nemazee
Hospital, Shiraz, Iran, were randomly allocated to control and intervention groups. The intervention
group received a 6‑h workshop based on Watson’s human care theory using a collaborative and
role‑playing approach and 1‑month follow‑up period through presenting weekly preplanned care
and caregiving scenarios. The control group received routine hospital trainings. The data collection
tools used were included in a demographic information form, and the Larson Caring Assessment
Questionnaire, and Kanungo Job Involvement Questionnaire. Data were analyzed using Chi‑square
test, and independent and paired t‑test in SPSS software. Results: Majority of the participants were
married women and had Bachelor of Science degree in Nursing. The participants’ age ranged from 21
to 52 years. After the education, caring behaviors and job involvement scores significantly increased
in the intervention group compared to the control group (p < 0.001). Conclusions: The findings
suggest that a care workshop can be effective in improving care behaviors and job involvement.
Therefore, we recommend more extensive research to determine the effectiveness of long‑term
intervention on nursing care behaviors.

Keywords: Education, intensive care units, nursing care, nursing theory

The Effect of Education Based on Human Care Theory on Caring
Behaviors and Job Involvement of Nurses in Intensive Care Units

Original Article

Maasumeh Elahi1,
Parisa Mansouri1,
Zahra Khademian1
1Department of Nursing, School
of Nursing and Midwifery,
Shiraz University of Medical
Sciences, Shiraz, Iran

How to cite this article: Elahi M, Mansouri P,
Khademian Z. The effect of education based on
human care theory on caring behaviors and job
involvement of nurses in intensive care units. Iranian
J Nursing Midwifery Res 2021;26:425‑9.

Submitted: 30‑Jun‑2020. Revised: 20‑Jul‑2020.
Accepted: 26‑May‑2021. Published: 02‑Sep‑2021.

including Intensive Care Units (ICUs).
All of the issues and problems associated
with patients in ICUs are of high
sensitivity and importance; hence, in this
environment, nursing performance should
be accompanied with adequate professional
nursing care in a timely manner.[7]

Caring behaviors include holistic patient
care, which is related to job satisfaction,
interest in staying on the job, and job
involvement. Job involvement is an
important issue in nursing because it
is linked to job commitment prediction
and the intention to stay.[8] According to
the definition provided by Kanungo, job
involvement refers to the state of a person’s
psychological identification with his or
her job.[9] In addition, nurses reported that
providing caring behaviors enhances their
commitment to the nursing profession
and organization.[10] Several quantitative
and qualitative studies have indicated that
nursing care behavior is a key motivational

This is an open access journal, and articles are
distributed under the terms of the Creative Commons
Attribution‑NonCommercial‑ShareAlike 4.0 License, which
allows others to remix, tweak, and build upon the work
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For reprints contact: [email protected]

Elahi, et al.: The effect of education on nurses

426 Iranian Journal of Nursing and Midwifery Research ¦ Volume 26 ¦ Issue 5 ¦ September-October 2021

factor influencing work involvement.[11‑13] Some studies
in Iran concluded that job involvement in nurses is at a
low[14] or moderate level[15,16] and we are faced with some
challenges in this regard. Thus far, interventions for the
improvement of caring behaviors in ICU nurses have
not been investigated in Iran. Therefore, this study was
conducted to determine the effect of education based on
human care theory on caring behaviors and job involvement
of nurses in ICUs.

Materials and Methods
This single‑blind, randomized, clinical trial
(IRCT2016121331396N1) was conducted from April
2017 to August 2018 amongst ICU nurses of Nemazee
Hospital affiliated with Shiraz University of Medical
Sciences, Iran. A total of 110 nurses who had the inclusion
criteria were selected through convenience sampling.
Then, the participants were randomly divided into control
and intervention groups by applying permuted block
randomization method. The sample size was calculated
using the sample size formula and based on the study by
Elhami et al.[17] (d = 1, SD = 1.7), and by considering a
type 1 error of 0.5, power of 80%, and sample loss of 20%
equal to 58 people in each group (total of 116). In total,
6 people dropped out of the study for various reasons, and
thus, 110 people participated until the end (55 participants
in each group) [Figure 1]. The inclusion criteria were at
least 6 months of work experience as an ICU nurse, no
history of an educational course regarding the subject of
this study, and no history of psychosocial or psychosomatic
problems according to self‑report data. The study exclusion
criteria were the desire to leave the study, and quitting or
going on long‑term leaves of absence.

The data collection tools included a demographic
information form, the Larson Caring Assessment
Questionnaire (Care‑Q), and Kanungo Job Involvement

Questionnaire. The demographic information form
included questions on age, gender, education, marital
status, and work experience in the ICU. The Care‑Q
was developed by Larson (1981) to measure nursing
care behaviors. In this tool, caring behaviors are ranked
from the most important behaviors to the least important
ones. The Care‑Q consists of 57 items in the 6 subscales
of prompt access of nurses (6 items), patient follow‑up
(8 items), trusting relationship (18 items), prediction of
patient’s needs (5 items), physical and emotional comfort
of the patient (11 items), and adequate explanation to
the patient (9 items). Each care behavior is scored on a
5‑point Likert‑type scale ranging from 5 to 1 (the most
important, relatively important, neutral, relatively low, and
the least important) to rate the degree of importance. The
minimum and maximum total score of the questionnaire is
57 and 285, respectively.[18] In the study by Zamanzadeh
et al.,[19] back translation was performed for the Care‑Q.
After preparation of the Persian version, the psychometric
properties of the Care‑Q related to validity and reliability
were assessed. Content validity was evaluated by 10 expert
panels and some small alterations were made in the items
based on their suggestions. Internal consistency reliability
was determined by calculating Cronbach’s α (alpha)
using the study sample responses. The results showed an
internal consistency reliability of 0.97 for all the items.
The correlation of this questionnaire was reported as
r = 0.87 and r = 0.83 in the study by Pashaee et al.[20] in
ICUs. The Job Involvement Questionnaire was designed
by Kanungo9] to assess job involvement amongst nurses.
This questionnaire consists of 10 questions. The questions
were scored on a 5‑point Likert‑type scale ranging from 5
to 1 (strongly disagree,[5] agree,[4] undecided,[3] disagree,[2]
strongly disagree[1]) to rate the level of agreement.
Items 3 and 7 are reverse scored. The Job Involvement
Questionnaire is a two‑part questionnaire; the first five
questions are related to job performance and the next set is
related to attitude, and the total score of the questionnaire
can range from 10 to 50. The interpretation of the results
is based on the total score, and higher scores indicate
higher job involvement.[9] The α coefficient and test–retest
reliability were reported at 0.87 and 0.85, respectively, by
Kanungo.[9] Moreover, Mirhashemi reported an acceptable
internal reliability of 0.807 and validity of 0.791 among
32 faculty members.[21] The questionnaires were completed
in the intervention and control groups before and 1 month
after the intervention.

The study intervention included a 6‑h workshop based on
Watson’s human care exercise through a collaborative and
role‑playing approach.[8] The 1‑month follow‑up period for
the intervention group included the weekly presentation
of preplanned cases and caregiving scenarios. For role
playing, a scenario was designed based on care behavior and
introduced to the participants; two of them were selected
as a client and nurse for the role‑playing. Researchers

Assessed for eligibility (n = 116)

Excluded (n = 0)
• Declined to participate (n = 0)

Randomized (n = 116)

Allocated to intervention group (n = 58)
• Received allocated intervention
(n = 58)

Allocated to Control group (n = 58)
• Received allocated routine plan
(n = 58)

Allocation

Follow-up

Analysis

Lost to follow-up (n = 3)
• Unwilling to continue research
(n = 3)

Analyzed (n = 55)
Excluded from analysis (n = 0)

Lost to follow-up (n = 3)
• Lack of willingness to continue the
research (n = 3)

Analyzed (n = 55)
Excluded from analysis (n = 0)

Enrollment

Figure 1: CONSORT flow diagram of the participants

Elahi, et al.: The effect of education on nurses

Iranian Journal of Nursing and Midwifery Research ¦ Volume 26 ¦ Issue 5 ¦ September-October 2021 427

coordinated and supervised the steps and important aspects
of the role playing. The control group only received the
periodic and routine hospital trainings. After completing the
intervention, for ethical considerations, a CD containing all
the information was distributed among the control group
participants. According to Watson’s theory, the content of the
training sessions was based on the five factors of formation
of a humanistic–altruistic system of values, the development
of a helping–trusting relationship, the promotion and
acceptance of the expression of positive and negative
feelings, the promotion of interpersonal teaching–learning,
and the cultivation of sensitivity to one’s self and to others.

Data analysis was performed using independent sample
t‑test, paired sample t‑test, and Chi‑square test in SPSS
software (version 21, IBM Corp., Armonk, NY, USA). p values
of less than 0.05 were considered to be statistically significant.

Ethical considerations

This study was approved by the local Ethics
Committee of Shiraz University of Medical Sciences
(ir.sums.rec. 1395.134). After explaining the goals and
method of this research, the informed consent form was
completed by the participants.

Results
A majority of the participants were women (90.00%),
were married (59.10%), and had a Bachelor of Science in
Nursing (90.00%). The mean (SD) of work experience in
the ICU was 6.71 (6.18) years, ranging from 6 months to
27 years. The age range of the participants was 21–52 years.
Based on the Chi‑square test and independent t‑test, there
was no significant difference between the two groups in
terms of demographic characteristics [Table 1]. Moreover,
the comparison of mean scores of caring behaviors and job
involvement indicated no significant differences between
the two groups before the intervention (p > 0.05) [Table 2].
In addition, based on paired t‑test, these scores significantly
increased in the intervention group compared to the control
group (p < 0.001).

According to the independent t‑test, the caring behaviors
and job involvement scores improved significantly after
the education in the intervention group. However, there
was no significant difference in the scores of caring
behaviors (p = 0.296) and job involvement (p = 0.266)
before and after the intervention in the control
group [Table 2].

Discussion
The findings of our study indicated that the scores of both
variables increased after the intervention. Therefore, it
can be concluded that care workshops based on Watson’s
human care theory can increase nurses’ level of caring
behaviors and job involvement.

The findings of the present study are consistent with that of
the study by Wu et al.[22] on nursing students trained based
on Watson’s 10 human carative factors. They reported a
significant difference between the two study groups after
the intervention.[22] Other investigations also showed that an
online caring curriculum and human caring theory training
program improved caring behaviors,[23,24] and concept
mapping and project‑based learning programs were effective
methods for the improvement of caring efficacy in nursing
students.[25,26] Wei et al.[27] reviewed 19 interventional studies
based on Watsons’ human caring theory, most of which
had indicated that interventions could decrease patient’s
emotional strain, and increase patients’ self‑management,
confidence, and emotional well‑being, nurse’s job
satisfaction and engagement, and nursing student’s
confidence in their clinical performance, and increase the
awareness of caring behaviors. Nurses’ caring behaviors
are influenced by numerous factors such as working
conditions, workload, management support, concern
related to patients’ health, and nurses’ perception about
caring.[28] Education can affect nurses’ perception and
improve their caring behaviors. In line with our study
results, the results of the study by Tsai et al.[8] showed that
caring behaviors and job involvement increased after the
intervention. Some studies revealed that nurses’ personal
and professional satisfaction with their job is positively

Table 1: Comparison of demographic variables between control and intervention groups
Variables Intervention Control p
Gender [n (%)]
Male 3 (5.50) 8 (14.50) 0.112
Female 52 (94.50) 47 (85.50)

Marital status [n (%)]
Single 26 (47.30) 19 (34.50) 0.175
Married 29 (52.70) 36 (65.50)

Degree [n (%)]
Bachelor’s degree 50 (90.90) 49 (89.10) 0.600
Master’s degree 5 (9.10) 6 (10.90)

Age (years) [mean (SD)] 31.27 (7.57) 30.82 (6.40) 0.735
Work experience in the ICU* (years) [mean (SD)] 6.94 (6.64) 6.48 (5.73) 0.706

*Intensive care unit

Elahi, et al.: The effect of education on nurses

428 Iranian Journal of Nursing and Midwifery Research ¦ Volume 26 ¦ Issue 5 ¦ September-October 2021

related to caring behaviors, and nurses who felt their caring
behaviors were recognized and rewarded were more likely
to be involved in their workplace.[1,12,29] In a study on ICU
nurses, Pashaee et al.[20] reported a high care score, which
suggested that nurses valued nursing care. Similarly, in our
study, the caring behavior score was high. Similar to the
present study, they investigated ICU nurses, and despite the
complex and skilled care procedures performed in ICUs, the
caring behaviors of nurses were suitable. In line with our
research, which was conducted on caring behaviors, several
investigations were performed to evaluate nurses’, nursing
students’, or patients’ perceptions of caring behaviors.[30,31]

Job involvement has a positive impact on organizational
goals that lead to a better outcome.[32] Nurses who have a
high level of commitment and job involvement present more
successful and appropriate nursing care.[33] A significant
relationship was found between job satisfaction and working
conditions, work environment, organization, job stress, role
ambiguity and conflict, understanding, and nurses’ job
description.[34] Positive organizational climate can create
commitment and help nurses to be more involved in their
profession;[35‑37] in addition, emotional labor of nurses can
influence their job involvement.[38] The results of our study
indicated that care education impacted job involvement.
Studies in this context reported the effect of organizational
commitment and support on job involvement[39,40] and the
effect of strong organizational culture, which can create
good quality of work‑life for nurses and improve their job
satisfaction and performance.[41]

The main limitations of the present study stem from
sampling limitations; it is possible that the sample of
nurses in this study is not representative of the Iranian
nurses as a whole. In addition, this study was conducted
amongst nurses working in ICUs of Nemazee Hospital in
Shiraz, Iran. Therefore, the results cannot be generalized
to other nurses and other health‑care centers. Therefore,
similar studies should be conducted in other clinical wards
to compare the quality and quantity of the obtained results
in more realistic conditions.

Conclusion
The present study results showed that care education

based on Watson’s human care theory can improve caring
behaviors and job involvement. Thus, it is clear that
applying the care research results is crucial for improving
and preserving the quality of nursing care management.
With respect to the effect of educational courses or seminars
on care behaviors, and subsequently, job involvement, it
would be appropriate for instructors to consider teaching
caring behaviors in nursing in‑service training programs to
increase the quality of community health and in the interest
of job retention.

Acknowledgments

The present study is the outcome of Maasumeh Elahi’s
M.Sc. thesis in nursing approved on January 18, 2017, in
Shiraz University of Medical Sciences with the research
project code 95‑01‑08‑11920 and with the financial support
of the Research Vice‑Chancellor of the university. Thus,
the authors would like to thank the Vice‑Chancellor of
Research, the Postgraduate Education Department of
Fatemeh College of Nursing and Midwifery, and the
officials and personnel of the Shiraz Nemazee Hospital
who contributed in the different stages of this investigation.

Financial support and sponsorship

This study was funded by Shiraz University of Medical
Sciences

Conflicts of interest

Nothing to declare.

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Table 2: The comparison of mean score of caring behavior and job involvement in the control and intervention groups
Variable Groups Preintervention mean (SD) Postintervention mean (SD) t p
Caring
behavior

Control 184.70 (12.04) 183.32 (11.28) 1.05 0.296
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t 0.28 25.35
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t 1.59 6.59
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*Paired sample t‑test. **Independent sample t‑test

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Checklist items are worded so that 1 of 5 responses is possible:

++

Indicates that for that particular aspect of study design, the study has been designed or conducted in such a way as to minimize the risk of bias.

+

Indicates that either the answer to the checklist question is not clear from the way the study is reported, or that the study may not have addressed all potential sources of bias for that particular aspect of study design.

Should be reserved for those aspects of the study design in which significant sources of bias may persist.

Not reported (NR)

Should be reserved for those aspects in which the study under review fails to report how they have (or might have) been considered.

Not applicable (NA)

Should be reserved for those study design aspects that are not applicable given the study design under review (for example, allocation concealment would not be applicable for case-control studies).

In addition, the reviewer is requested to complete in detail the comments section of the quality appraisal form so that the grade awarded for each study aspect is as transparent as possible.

Each study is then awarded an overall study quality grading for internal validity (IV) and a separate one for external validity (EV):

++ All or most of the checklist criteria have been fulfilled, where they have not been fulfilled the conclusions are very unlikely to alter.

+ Some of the checklist criteria have been fulfilled, where they have not been fulfilled, or not adequately described, the conclusions are unlikely to alter.

− Few or no checklist criteria have been fulfilled and the conclusions are likely or very likely to alter.

Checklist

Study identification: (Include full citation details)

Study design:

Refer to the glossary of study designs (
appendix D
) and the algorithm for classifying experimental and observational study designs (
appendix E
) to best describe the paper’s underpinning study design

Guidance topic:

Assessed by:

Section 1: Population

1.1 Is the source population or source area well described?

Was the country (e.g. developed or non-developed, type of healthcare system), setting (primary schools, community centers, etc.), location (urban, rural), population demographics, etc. adequately described?

++

+

NR

NA

Comments: the study is based on the use of the participants or the students enrolled in Bushehr nursing and midwifery school. These are the students in their third semester of nursing and midwifery program and have access to computer or midwifery program.

1.2 Is the eligible population or area representative of the source population or area?

Was the recruitment of individuals, clusters, or areas well defined (e.g. advertisement, birth register)?

Was the eligible population representative of the source? Were important groups under-represented?

++

+

NR

NA

Comments: The population selected is well described, however, the study utilized a small sample size. Therefore, it is impossible to generalize the outcomes to teach other courses since it is not guaranteed that the integration of the FC and the NPE will be the most effective strategy.

1.3 Do the selected participants or areas represent the eligible population or area?

Was the method of selection of participants from the eligible population well described?

What % of selected individuals or clusters agreed to participate? Were there any sources of bias?

Were the inclusion or exclusion criteria explicit and appropriate?

++

+

NR

NA

Comments: the selected participants represented the population within the specified area of Bushehr nursing and midwifery school. The article shows that 82 nursing and midwifery students were enrolled and fails to give the true data on those who were selected and those who dropped out of the study. The inclusion and the exclusion criteria were explicit and in this case, the inclusion criteria were based on the students in their third semester of nursing and midwifery program, having access to a computer or smartphone. The exclusion included absenteeism for any reason, not viewing educational content, and the unpreparedness to continue with the study.

Section 2: Method of allocation to intervention (or comparison)

2.1 Allocation to intervention (or comparison). How was selection bias minimized?

Was allocation to exposure and comparison randomized? Was it truly random ++ or pseudo-randomized + (e.g. consecutive admissions)?

If not randomized, was significant confounding likely (−) or not (+)?

If a cross-over, was the order of intervention randomized?

++

+

NR

NA

Comments: the subject were allocated to the four groups through block randomization.

2.2 Were interventions (and comparisons) well described and appropriate?

Were interventions and comparisons described in sufficient detail (i.e. enough for the study to be replicated)?

Were comparisons appropriate (e.g. usual practice rather than no intervention)?

++

+

-−

NR

NA

Comments: detailed description of both comparison and the interventions is provided. The intervention of the flipped classroom through near-peer education (FC through NPE) on the patient safety awareness retention in nursing and midwifery learners as compared to the conventional intervention (Comparison).

2.3 Was the allocation concealed?

Could the person(s) determine the allocation of participants or clusters to intervention or comparison groups have influenced the allocation?

Adequate allocation concealment (++) would include centralized allocation or computerized allocation systems.

++

+

NR

NA

Comments: the subjects were allocated to four groups through the use of block randomization.

2.4 Were participants or investigators blind to exposure and comparison?

Were participants and investigators – those delivering or assessing the intervention kept blind to intervention allocation? (Triple or double-blinding score ++)

If lack of blinding is likely to cause important bias, score −.

++

+

NR

NA

Comments: the investigators never considered some key elements that might impact the overall outcomes of the research. For example, there was a failure to find out whether the integration of the conventional and the comparison method was effective compared to the FC and the NPE. Other factors such as motivation, experience, and attitudes that are important in the comparison groups were not considered the confounding variables.

2.5 Was the exposure to the intervention and comparison adequate?

Is reduced exposure to intervention or control related to the intervention (e.g. adverse effects leading to reduced compliance) or fidelity of implementation (e.g. reduced adherence to protocol)?

Was lack of exposure sufficient to cause important bias?

++

+

NR

NA

Comments: the exposure to intervention and comparison was not adequate. The integration of the conventional method failed to determine if the integrated method was more effective compared to the new techniques like FC and NPE.

2.6 Was contamination acceptably low?

Did any in the comparison group receive the intervention or vice versa?

If so, was it sufficient to cause important bias?

If a cross-over trial, was there a sufficient wash-out period between interventions?

++

+

NR

NA

Comments: the intervention group received educational content online for 14 days and later attended the FC through NPE. On the other hand, the control groups were merely provided with an education that is based on the conventional technique. The use of this method together with the new method failed to find out whether the integrated method would be effective compared to FC and NPE alone.

2.7 Were other interventions similar in both groups?

Did either group receive additional interventions or have services been provided differently?

Were the groups treated equally by researchers or other professionals?

Was this sufficient to cause important bias?

++

+

NR

NA

Comments: the groups receive different interventions for example the groups were divided into four. The subject in the intervention groups received the educational content online for 14 days and subsequently attended the FC through NPE. The control groups were merely provided with an education based on the conventional technique. Both groups received a post-test after the completion of the program and once again four weeks after it.

2.8 Were all participants accounted for at the study conclusion?

Were those lost-to-follow-up (i.e. dropped or lost pre-, during or post-intervention) acceptably low (i.e. typically <20%)?

Did the proportion drop differ by group? For example, were drop-outs related to the adverse effects of the intervention?

++

+

NR

NA

Comments: There was no mention anywhere about the participants who dropped out of the study.

2.9 Did the setting reflect usual UK practice?

Did the setting in which the intervention or comparison was delivered differ significantly from usual practice in the UK? For example, did participants receive intervention (or comparison) conditions in a hospital rather than a community-based setting?

++

+

NR

NA

Comments: even though the researchers enrolled 82 nursing and midwifery learners enrolled from Bushehr nursing and midwifery school (community-based setting)

2.10 Did the intervention or control comparison reflect usual UK practice?

Did the intervention or comparison differ significantly from usual practice in the UK? For example, did participants receive the intervention (or comparison) delivered by specialists rather than GPs? Were participants monitored more closely?

++

+

NR

NA

Comments: The participants received the interventions i.e. the subjects on the Flipped Classroom through the Near Peer Education on the knowledge retention in nursing on the safety of the patient. The targeted groups were the nurses and the midwifery learners.

Section 3: Outcomes

3.1 Were outcome measures reliable?

Were outcome measures subjective or objective (e.g. biochemically validated nicotine levels ++ vs self-reported smoking −)?

How reliable were outcome measures (e.g. inter- or intra-rater reliability scores)?

Was there any indication that measures had been validated (e.g. validated against a gold standard measure or assessed for content validity)?

++

+

NR

NA

Comments: the measures of the outcome were reliable. The measures such as the Kruskal-Wallis test and the Chi-Square among others help in comparing the variable between the four groups. They also revealed the means score of the dependent groups for example the t-test assisted in revealing this. One ANOVA and the t-test were used for the independent samples to compare between-group comparisons.

3.2 Were all outcome measurements complete?

Where all or most study participants who met the defined study outcome definitions likely to have been identified?

++

+

NR

NA

Comments: the study outcomes show that the post-test means scores of the knowledge retention in both interventions were similar but high in the control groups. There were no significant differences between the four study groups.

3.3 Were all important outcomes assessed?

Were all important benefits and harms assessed?

Was it possible to determine the overall balance of benefits and harms of the intervention versus comparison?

++

+

NR

NA

Comments: the overall outcomes were effectively assessed. The use of FC through NPE leads to an increase in the mean score of the PSKRE hence boosting the learning, nevertheless, it did not affect the retention of the knowledge linked to the patient safety in nursing and the midwifery learners. The authors also warned about the use of the outcome for the generalization of teaching other courses since it does not implies that the integration of the FC and the NPE is an effective strategy.

3.4 Were outcomes relevant?

Where surrogate outcome measures were used, did they measure what they set out to measure? (e.g. a study to assess the impact on physical activity assesses gym membership – a potentially objective outcome measure – but is it a reliable predictor of physical activity?)

++

+

NR

NA

Comments: the outcome of the study is important to the students while practicing as nurses and midwifery. It shows that the integration of the FC and the NPE compared to the conventional technique broadens the levels of knowledge in the learners in the field of patient safety. The FC through the NPE and the conventional techniques helps in boosting the learner’s knowledge and this was evident in the within-group. there is also an increase in the learning process after receiving FC through NPE. The outcome of the study is also important since it supports the use of the process of integrating the pedagogical techniques that need to be used for the creation of active learning thinking in learners.

3.5 Were there similar follow-up times in exposure and comparison groups?

If groups are followed for different lengths of time, then more events are likely to occur in the group followed up for longer distorting the comparison.

Analyses can be adjusted to allow for differences in length of follow-up (e.g. using person-years).

++

+

NR

NA

Comments: There were follow-up groups in the study, however, the authors failed to report on whether there was a follow-up program. There is also no mention of the number of days that were taken for the follow-up program.

3.6 Was follow-up time meaningful?

Was follow-up long enough to assess long-term benefits or harms?

Was it too long, e.g. participants lost to follow-up?

++

+

NR

NA

Comments: The authors failed to report on the number of days that were allocated for the follow-up even though there were groups in the four mentioned groups of study.

Section 4: Analyses

4.1 Were exposure and comparison groups similar at baseline? If not, were these adjusted?

Were there any differences between groups in important confounders at baseline?

If so, were these adjusted for in the analyses (e.g. multivariate analyses or stratification).

Were there likely to be any residual differences of relevance?

++

+

NR

NA

Comments: even though the authors failed to provide the baseline information related to what is tested, the subjects were allocated to four groups through the block randomization approach. The authors managed to ensure that the subjects in the intervention groups were provided with the educational content online for 14 days and later attended the Flipped Classroom through the NPE. On the other hand, the control groups merely received an education based on the conventional technique.

4.2 Was the intention to treat (ITT) analysis conducted?

Were all participants (including those that dropped out or did not fully complete the intervention course) analyzed in the groups (i.e. intervention or comparison) to which they were originally allocated?

++

+

NR

NA

Comments: yes, the intention to treat was performed as the authors focused on finding out the effect of the flipped classroom through the near-peer education (FC through NPE) on the patient safety knowledge retention in nursing and midwifery learners. This is important in addressing the safety of the patients since it allows the nurses and the midwifery to acquire the knowledge for the performance of the required services targeted at improving the safety of the patients.

4.3 Was the study sufficiently powered to detect an intervention effect (if one exists)?

A power of 0.8 (that is, it is likely to see an effect of a given size if one exists, 80% of the time) is the conventionally accepted standard.

Is a power calculation presented? If not, what is the expected effect size? Is the sample size adequate?

++

+

NR

NA

Comments: according to the information provided in the article, the authors failed to provide the power to help in the detection of the intervention effect. It, therefore, implies that it becomes hard to determine the expected effect. The sample size used by the authors is also inadequate and this resulted in the occurrence of a wide interval range. Therefore, this somehow interfered with the accuracy of the study outcomes.

4.4 Were the estimates of effect size given or calculable?

Were effect estimates (e.g. relative risks, absolute risks) given or possible to calculate?

++

+

NR

NA

Comments: Based on the information from the article, there is no evidence of the estimated effect of the size provided. This means that the authors failed to provide information on the relative or the absolute risks. This was evident despite the availability of the risks to the safety of the patients. According to the article, there is a need to ensure that there is an ongoing process of monitoring the risks, developing the strategies to help in the reduction of the risks, eliminating the risks, and preventing the transfer of the risks. dealing with the issue also requires an effective communication process. Nevertheless, the authors failed to provide the effect estimates associated with the relative risks, absolute risks.

4.5 Were the analytical methods appropriate?

Were important differences in follow-up time and likely confounders adjusted for?

If a cluster design, were analyses of sample size (and power), and effect size performed on clusters (and not individuals)?

Were subgroup analyses pre-specified?

++

+

NR

NA

Comments: the authors adopted descriptive statistics that included the frequency, the mean, and the SD. The analysis was performed on the individuals and was divided into subgroups. The authors utilized the Shapiro-Wilk test to help in the examination of the data distribution. The Kruskal-Wallis test, Chi-Square test, and Fisher’s exact test were utilized in comparing the demographic variables between the four groups. The authors utilized the t-test or the repeated measures analysis of the variance (ANOVA) to perform the comparison of the means scores of the dependent groupings. The authors adopted the independent t-test and the one-way ANOVA for between-group comparisons.

4.6 Was the precision of intervention effects given or calculable? Were they meaningful?

Were confidence intervals or p values for effect estimates given or possible to calculate?

Were CI’s wide or were they sufficiently precise to aid decision-making? If precision is lacking, is this because the study is underpowered?

++

+

NR

NA

Comments: the scores and the p-value of the patient safety knowledge before the intervention in the two groupings of the control and intervention are given to be 15.60 + or – 1.92 and 16.65 + or -2.10 respectively with the p-value of 0.098. The authors also provided the means score and the probability of the two groups that reveal no statistically significant differences in terms of the changes i.e. mean score of 1.89 ad the p-value of 0.071. In group two, the intervention group, and the total control groups in the follow-up, there is a significantly lower mean score for the Patient Safety Knowledge Retention Exam (PSKRE) compared to the posttest.

Section 5: Summary

5.1 Are the study results internally valid (i.e. unbiased)?

How well did the study minimize sources of bias (i.e. adjusting for potential confounders)?

Were there significant flaws in the study design?

++

+

Comments: The study was based on the method of the randomized controlled trial using a pretest-posttest and the follow-up as well as the intervention and the control groups. The authors utilized Solomon’s four-group design to ensure that there is a removal of the effects of the pretest in the sensitization of the learners and the prevention of the potential damages to the external validity of the study. The authors also ensured that the samples were randomly divided into four groups i.e. two in the intervention groups and the two in the control groups. The authors only administered the pretest to a single intervention group and a single control group. the four groups were provided with the post-test/follow-up knowledge retention. However, the authors failed to explain how the biases that might have occurred as a result of the limitations of the study were addressed.

5.2 Are the findings generalizable to the source population (i.e. externally valid)?

Are there sufficient details given about the study to determine if the findings are generalizable to the source population? Consider participants, interventions and comparisons, outcomes, resources, and policy implications.

++

+

Comments: Even though the study reveals that the use of the Flipped Classroom through the Near Peer Education (FC through PE) leads to an increase in the knowledge mean score, it failed to impact the retention of the knowledge in terms of patient safety in nursing and midwifery learners. There are also limited studies in the field and the present study utilized a small number of samples. The study also failed to consider the key variables such as satisfaction of the learners and the failure to consider the effectiveness of the integrated technique compared to the FC and NPE alone. the results of the study cannot be generalized to teaching other courses since it does not necessarily imply that the integration of the FC and the NPE is the most effective strategy.

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