SHSU DEPARTMENT OF NURSING

NURS 3360 INTRODUCTION TO NURSING RESEARCH

NURSING RESEARCH APPRAISAL TOOL
From: Schmidt, N.A. & Brown, J.M. (2012). Evidence-based practice for nurses: appraisal and
application of research, (2nd ed). Sudbury, MA: Jones & Bartlett. ISBN: 978-1-4496-2407-1
Name: Paloma Garcia, Sophia Jones, Amanda Mudge, Kelsey Tolar, and Sury Zarate
Date: 06/23/2015
INTRODUCTION
Question 1
Does the Introduction demonstrate the need for the study?

Score
3

Rationale for the score value:

Sugama, Sanada, Shigeta, Nakagami, and Konya (2012) justify the need of this study with the
high prevalence rates of incontinence-associated dermatitis (IAD), results of studies focused on
the functioning of new types of pads, and the lack in proving the efficacy of such pads.
According to Sugama et al. (2012), the prevalence rates of IAD varies between 5.6-50%, while
the prevalence of IAD and simultaneous use of diaper and absorbent pads is prevalent in a 17%
of the Japanese older patients with incontinence (p. 1). These rates enhance the need of
performing a study over the causes and treatments for IAD. In addition, Sugama et al. (2012)
provide results of studies that demonstrated significant association between pH level of
incontinence pads used and pH level of the skin and its moisture content (p. 1). Finally, Sugama
et al. (2012) found a gap in knowledge because although previous studies demonstrated that the
newly developed more absorbent pads have a contribution in the control of IAD, the efficacy of
these pads has not been proven yet (p. 2). Therefore, the introduction demonstrates the need for
the study.
Question 2

Score

Is the problem presented clearly and concisely and with enough

background material to acquaint the reader with the importance of it?

Rationale for the score value:
The problem is presented clearly and concisely: the efficacy of newly developed more absorbent
pads in the control of IAD has yet to be demonstrated (Sugama et al., 2012, p. 2). Further, the
importance of the problem is enhanced by: (a) the high prevalence rates of IAD in the older adult
population, (b) the predisposition of older adults to skin impairment due to a decreased skin
barrier function due to aging reduces the resistance of the skin to moisture exposure, (c) the
observation of an increased moisture content and pH level of the stratum corneum of the buttock
skin as a result of urinary incontinence, and (d) the demonstrated a significant association
between pH level of the surface of incontinence pads used and pH level of the skin and its
moisture content (Sugama et al., 2012, p. 1).
Question 3
Is the purpose of the study clearly stated? Are the terms, variables, and

Score
2

assumptions relevant to the study clearly identified and described?

Rationale for the score value:
Sugama et al. (2012) clearly stated the purpose of the study, which was to examine the efficacy
of the test absorbent pad against IAD. We hypothesized that the skin condition of older adult
women with IAD would improve faster with the use of the test absorbent pad versus usual pad as
control (p. 2). The variables and assumptions relevant to the study are also clearly identified and
described. The relevant variables in this study are the skin condition with IAD and the type of
pad used for incontinence. In this case, the independent variable, intervention or treatment that
is manipulated by the researcher (Schmidt & Brown, 2015, p. 84), is the type of pad because it
is what the researchers are modifying to evaluate the effect that a more absorbent pad has in the
skin condition of incontinent people with IAD. Thus, the dependent variable, outcome or

variable that is influenced by the independent variable (Schmidt & Brown, 2015, p. 84), is the
skin condition of the patient. The assumption is that the use of more absorbent pads, compared to
traditional pads, would help skin condition with IAD recover faster (Sugama et al., 2012, p. 2).
In contrast to the clarity in which the purpose, variables, and assumptions were described, the
terms are only partially identified in the study. On one hand, Sugama et al. (2012) identified the
term IAD: IAD was described as a variety of terms including perineal skin injury [2], diaper
dermatitis [3], and irritant contact dermatitis of the vulva [4] in previous studies (p. 1). On the
other hand, the researchers do not specify the terms of the more absorbent pads used on the study
nor what they meant with efficacy. For this reason, this question is below expectations.
REVIEW OF THE LITERATURE (ROL)
Question 1
Is the ROL relevant to the problem? Is it adequate in terms of the range and

Score
3

scope of ideas, opinions, and viewpoints relevant to the problem?

Rationale for the score value:
The review of literature for this article is relevant to the problem presented by Sugama et al. The
authors cited their previous study that demonstrated a correlation between absorbent pad usage
and IAD in older women. Sugama et al. (2012) then stated, based on these results we expected
that unless the absorbent pad that is in direct contact with the skin is modified and improved,
IAD could not be managed (p. 2). This statement is what lead them to test the efficacy of the
test absorbent pad against IAD (Sugama et al., 2012, p. 2).
Schmidt and Brown (2015) state that the review should focus on the most recent work in the
field but may include older citations if they are considered to be landmark studies (p. 19). By
this definition we assert that the terms of range and scope were met. Sugama et al. used older
citations from 1996 and 2006 in order to define the prevalence of IAD and used newer citations
from 2010 to prove that the study was needed to determine the efficacy of the test absorbent pad

against IAD (Sugama et al. 2012, p. 2).

This review of literature does present ideas and viewpoints that are relevant to the problem, but it
fails to present any opinions. Sugama et al. (2012) cite Farage and colleagues because of the
their demonstration that an improved apertured film plus feminine pad for appeared to
contribute less to the further development of inflammation (p. 2). This study is relevant in terms
of its ideas and viewpoints in relation to the study at hand, but there is no opinion associated with
it.
REVIEW OF THE LITERATURE (ROL) cont
Question 2
Is the ROL well organized and synthesized? Does it provide a critical

Score
2

appraisal of the contribution of each of the major references?

Rationale for the score value:
This article has a review of literature that is well organized but not well synthesized. Sugama et
al. (2012) began by citing Gray, Bliss, Doughty, Ermer-Seltun, Kennedy-Ebans, and Palmers
study that found the prevalence of incontinence associated dermatitis (p. 2). This indicates that
further research needs to be done in order to find a solution for incontinence associated
dermatitis. Sugama et al. (2012) then cited their previous study on the relationship between
absorbent pad usage and incontinence associated dermatitis. By showing the relationship
between absorbent pad usage and IAD, Sugama et al. (2012) lead the readers to their current
topic to be studied, which is the efficacy of the test absorbent pad again IAD. (p. 2).
This review of literature was not well synthesized because the authors left out several key items
of a review of literature. Schmidt and Brown (2015) stated that for each study included in the
review, the purpose, sample, design, and significant findings are discussed (p. 19). Sugama et
al. (2012) failed to provide the purpose, sample, and design for each study they cited. The
authors only gave the readers significant findings for each study, which can be misleading if the

full study is not read.

This review of literature does not provide a critical appraisal of the major references. Schmidt
and Brown (2015) state, to remedy some of the concerns about bias, the Appraisal of Guidelines
Research and Evaluation (AGREE II) instrument was developed as part of an international
collaborative of researchers and policymakers (p. 430). Sugama et al. should have used the
AGREE II instrument to evaluate each one of their contributing major references, rather than not
providing any appraisal at all.
Question 3
Does the ROL include a summary of the literature with implications for the

Score
2

study? Is it adequately and correctly documented?

Rationale for the score value:
The review of literature does not include a summary of the literature or implications for the
study. Sugama et al. (2012) cited several studies in an effort to demonstrate a need for their
research, but each study only included the results and not a brief summary of the study. Schmidt
and Brown (2015) stated that for each study included in the review, the purpose, sample, design,
and significant findings are discussed (p. 19). Without having a summary of the study the reader
is forced to be bias toward Sugama et al. (2012) and assume that the full study is in fact relevant
to the topic. Sugama et al. (2012) did indicate a gap in knowledge in regards to the topic, but
without a summary of each study cited, readers will not know how the study impacts any
existing knowledge. Sugama et al. (2012) did provide appropriate citation for each study
presented. A complete citation is provided for each article so that readers can retrieve the
articles if desired. (Schmidt and Brown, 2015, p. 19).
METHODS
Question 1
Was there an adequate description about how human subjects were
protected?

Score
2

Rationale for the score value:

The authors finish the methods section stating that ethical considerations were taken in the study
(Sugama et al., 2012, p. 3). According to the article, the study objective and procedures were
explained to the study subjects or to their family members, and written informed consent was
obtained. This study was approved by the Ethics Committee of the Graduate School of Medicine,
University of Tokyo (#1817) (Sugama et al., 2012, p. 3). However, the authors failed to provide
detailed information regarding how the human subjects were protected. For example, they did
not mention how the identities of their participants were protected.
Question 2
Was data collection clearly described? Were the instruments appropriate and

Score
2

described fully in terms of content, structure, validity, and reliability?

Rationale for the score value:
There are multiple aspects the researchers took into account to implement efficient data
collection. Sugama et al. (2012) clearly described how the data was collected for the main
outcomes, skin condition. Sugama et al. (2012) specified who was doing the skin observation
and photographs of the buttocks, when, and how the information was analyzed: skin
observation and photographs of the buttock area were undertaken for both test pad group and the
control group every day at 20:00 by 3 researchers (p. 2). However, although Sugama et al.
(2012) provided specific information regarding to the instrumentation used to assess the cure and
severity of IAD (pp. 2-3), they did not provide any information about the cameras used for the
photographs. This lack of information could lead to a threat to instrumentation, which is a threat
to internal validity when there are inconsistencies in data collection (Schmidt & Brown, 2012, p.
161), and jeopardize the reliability and replicability of the study. In addition, the details of data
collection for secondary outcomes, moisture content of the stratum corneum and skin pH, were
very specific in terms of when and how, but missed to specify who was in charge of obtaining

such data or how was trained. Sugama et al. (2012) stated that on the first day of the study, 10
research assistant who had undertaken skin observation training were split into pairs (p. 2), but
the authors do not mention if such training was also applied to the data collectors for secondary
outcomes. Regarding to the details of when secondary outcomes data were obtained, Sugama et
al. (2012) specified that moisture content of the stratum corneum of the coccyx skin and skin
pH were measured at the time of recruitment and at the end of the study (p. 3). Additionally, the
instruments used to measure the secondary outcomes were explained clearly. One of the
instruments used was the Corneometer CM825, which helped measure the moisture content of
the stratum corneum of the coccyx (Sugama et al., 2012, p. 3). Sugama et al. (2012) stated ...its
reliability and adequacy have been demonstrated (p. 4). Furthermore, Sugama et al. (2012) used
the Skin-pH-meter, which in the same manner, has been demonstrated to be reliable. Other
instruments partially described are the statistical analysis tools. On page three, the instruments
used for the statistical analysis were clearly described and seem appropriate and reliable, but
information regarding to who was in charge of performing the statistical analysis was not
provided. Finally, one more instrument jeopardizes the validity and reliability of the study.
According to Sugama et al. (2012), the diaper used for the experimental group had to be
switched to the hospital-standard pad and diaper because the allowance volume of the test pad
was not adequate to the care regimen for changing the incontinence pad during the night in the
test hospital (p. 2). This lack of material to implement the study is one of the biggest threats to
the test of the efficacy of the new-developed pad.
METHODS cont
Question 3
Was the sample selection appropriate? The sample size adequate? Attrition
reported and explained? Did the design have controls at an acceptable level

Score
2

for threats to internal validity?

Rationale for the score value:
The sample selected was not adequate for the purpose of the study, which
was to examine and compare the efficacy of an improved absorbent pad and
a standard pad against IAD in female older adults. The sample selection was
not appropriate because there is an incongruence between two statements.
On one hand, Sugama et al. (2012) stated that theinclusion criteria were
adult women aged 65 years, diagnosed with IAD, and full time user of
diapers (including absorbent pads) because of urinary incontinence (p. 3).
On the other hand, it is stated that no criteria were specified regarding the
type of incontinence (Sugama et al., 2015, p. 3). Therefore, this
contradiction between the target population and the actual sample risks the
appropriateness of the sample selection.
In contrast, the sample size in this study is adequate. The sample size was 62 initially; 31 in the
control group and 31 in the experimental group. Throughout the study one subject from each
group dropped out. This attrition rate, which is considered a threat to internal validity, did not
affect the results of the study due to the minimal change in sample size (Schmidt & Brown,
2015, p. 162). In this study, the researchers applied the rule of 30, which, according to Schmidt
and Brown (2015), states that in order to have a sufficient sample size to adequately represent
the target population, there needs to be a minimum of 30 subjects in each group being studied
(p. 162).
Additionally, the researchers used different techniques to minimize the threats of internal
validity. Although, as mentioned previously, internal validity is highly jeopardized due to the
lack of enough experimental diapers, the research controlled many other threats. First, each

subject was randomly assigned to their group. The randomization occurred at unit level to avoid
contamination and the units were randomized using opaque envelopes by a researcher not
involved in the study. An independent researcher randomized ten units at a 500-bed geriatric
medical hospital (Sugama et al., 2012, p. 2). With this control, researchers decreased the threat
of selection bias. In addition, Sugama et al. (2012) prevented bias by designing a blind study.
Sugama et al. stated that effective blinding was not possible for the intervention administrator
because the appearance of the test absorbent pad clearly differed from that of control pad (p. 2);
but solved this problem by using an outcome evaluator who did not know which participant
belonged to the control group or to the experimental group: the skin evaluator who was not
involved in the intervention served as a blinded outcome evaluator(p. 2). With this design,
Sugama et al. (2012) minimized the threat to internal validity. In the same way, the threat of
maturation is minimized due to the duration of the study, which was until the patient completely
recovered from IAD lasting a maximum of one week. Furthermore, the threat of instrumentation
was controlled in all instrument used by the cameras; the same instrumentation methods were
used to measure the data at the same time everyday, such as the IAD skin condition assessment
tool which had three different ratings to define: breakdown, redness, and erosion; the
Corneometer to measure the moisture content of the stratum corneum; and the skin pH value
with the Skin-pH-meter PH900. According to Schmidt and Brown (2015), when data collection
is based on observation, ...researchers need to ensure all data collectors are comprehensively
trained (p. 161). As stated in the article, on the first day of study, 10 research assistants who
had undertaken skin observation training were split into pairs (Sugama et al., 2012, p. 3);
therefore, researchers control instrumentation from threatening the internal validity of the study.
Finally, statistical conclusion validity, which is the degree that the results of the statistical

analysis reflect the true relationship among the independent and dependent variables (Schmidt
& Brown, 2015, p. 162), is controlled by the design of the study. Although Sugama et al. (2015)
did not specify who was in charge of performing the statistical analysis, data about the
instrument used and the reliability of those is specified. According to Schmidt and Brown
(2015), researchers can control for low reliability of the measures by using well-established
and well-designed instruments (p. 162); thus, Sugama et al. (2015) controlled this threat to
internal validity. In conclusion, Sugama et al. implemented several measures to control the
internal validity of the study; however, the inadequate amount of experimental diapers reduced
chances to obtain the accurate efficacy of the new-developed diapers.
Question 4
What are the limits to generalizability in terms of external validity?

Score
2

Rationale for the score value:

Although Sugama et al. (2012) designed this study with several control measures for external
validity, there are two main threats that can jeopardize the generalizability of this study. On one
hand, researchers control the experimenter reactivity that threatens external validity by
implementing a blind design: IAD was rated based on the buttock pictures performed by a
researcher who was not aware of the test pad and control group allocation (Sugama et al., 2012,
p. 3). On the other hand, the effects of selection and interaction of treatment and setting threat the
external validity. Representativeness of the sample is essential. If the sample does not represent
the population, effects of selection limit whether study can be generalized to the population
(Schmidt & Brown, 2012, p. 164). As stated on the previous question, there is an incongruence
between the sample and the population. Sugama et al. (2012) first stated that inclusion criteria
includes being full-time user of diapers (including absorbent pads) because of urinary
incontinence, and at the very next sentence they add that no criteria were specified regarding the
type of incontinence (p. 2). This contradiction means that the sample does not represent the

population they want to study, urinary incontinent older women, and therefore reduces the
generalizability of the study. In addition, interaction of treatment and setting can affect external
validity. According to Schmidt and Brown (2015), this interaction is concerned with whether
results from an intervention conducted in one setting can be generalized to another setting where
the same intervention is used (p. 165). This interaction is possible to occur in this study because
the frequency, procedure, and skin care routines of changing diapers in both groups followed
the hospitals care standards (Sugama et al., 2015, p. 2). This means that in hospitals with
different standards may not obtain the same results of this study.
Question 5
Is the study qualitative (words) or quantitative (numbers)

What is the name/term for the study design?

Rationale for the score value:
This is a quantitative experimental research study. Specifically, a two group pretest-posttest
design. To be considered a true experimental design, a study must have three features present:
randomization, control, and manipulation (Schmidt & Brown, 2015, 176). In addition,
according to Schmidt and Brown (2015), in a two group pretest-posttest design, subjects are
randomized to either the experimental group receiving the intervention or the control group.
They are measured before and after the intervention is implemented. This design allows the
researchers to examine within-subjects results as wells as between-subjects results (p. 177).
This study meets all the characteristic of this type of quantitative research study. First, out of 62
subjects who were selected for this study, the researchers randomly assigned them to either a
control group or an experimental group in equal numbers. Second, there is a manipulation of an
independent variable. In Sugama et al. (2012)s study, the type of diaper, independent variable, is
manipulated in the experimental group to compare the effects of the newly developed diaper to
effects of the hospital-standard diaper used on the control group. Finally, measurements of the

skin integrity, pH level, and moisture content stratum corneum of the coccyx were taken before
and after the study to compare the results within-subjects and between-subjects. Therefore, the
three features that make a study to be considered experimental are present in this study.
RESULTS
Question 1
Was the data clearly presented? The sample characteristics described?

Score
3

Rationale for the score value:

The purpose of the article was to examine the efficacy of an improved absorbent pad against
IAD (Sugama et al., 2012, p. 1). The results from the data collected compared the test absorbent
pad versus the standard absorbent pad in relation to IAD skin condition mainly, while also
observing skin pH at baseline, healing curve, moisture content, and IAD total score change. The
data collected was presented clearly; however, the study was flawed and the results obtained
were influenced by the threat of instrumentation. According to Schmidt and Brown (2015),
instrumentation is a threat to internal validity when there are inconsistencies in data collection
(p. 161). The article stated the study failed to completely use only the test absorbent pad during
the 24-hours study. Sugama et al (2012) stated, patients in the intervention group were the test
absorbent pad and a diaper throughout the day from 09:00 to 20:00.During the night (from
20:00 to 09:00), patients in the intervention group wore the hospital-standard pad and a diaper.
The reason for this switch pad was that the allowance volume of the test pad. The allowance
volume of the test pad was not adequate to the care regimen for changing the incontinence pad
during the night in the test hospital (p. 2). On the other hand, the control group continued to
wear their standard pad and diaper at all times during the experiment. The sample characteristics
were described clearly and gave a good baseline data about the participants characteristics, IAD
skin condition, moisture content, and skin pH. The outcome measures provided the comparison
in the participants IAD total score change, and healing curve. Ultimately, the overall results,

were clear and supported the hypothesis of pad absorbent efficacy in an improved pad. Though
the design flaw regarding the volume allowance of the test pad is questionable, the study was
overall a good attempt.
RESULTS cont
Question 2
Was the best analysis method selected? Are the tables, charts, and graphs

Score
3

pertinent?
Rationale for the score value:
The best analysis method was selected. Sugama et al. (2012) mentioned the, Cox proportional
hazard analysis was used to assess predictors of healing outcomes. The relation between type of
absorbent pad and change in symptoms (improved versus unchanged/worsened) (p. 3). This
analysis method provided organized data with a comparison of the test absorbent group and its
efficacy on participants with IAD that used their pad. The analysis used helped the researchers
identify whether their aim of the study was in fact effective. The tables in the article identified
how the participants were selected (ultimately 60 patients divided into the study and control
groups), the specific criteria required to participate in the study (female patients ages 65 and
older with urinary incontinence), the specific diagnosis of IAD, and how the use of an improved
absorbent pad positively affected the recovery from incontinence-associated dermatitis.
DISCUSSION
Question 1
Score
Were results based on the data, sufficient to draw conclusions, and interpreted
3
in the context of the purpose, hypothesis, framework, and literature review?
Rationale for the score value:
The purpose of the study was to compare the effectiveness of a test absorbent pad on older
women with urinary incontinence. The hypothesis states that the skin condition of older adult
women with IAD would improve faster with the use of the test absorbent pad versus usual pad as

control (Sugama et al., 2012, p. 2). The results based on the data gave the conclusion that using
the test incontinence absorbent pad that incorporates frontal absorption and a backflow
prevention mechanism, a significantly faster, full recovery was observed among older women
with urinary IAD compared with those in the control group using a conventional pad. Our
research suggest good efficacy of the test absorbent pad in facilitating recovery from IAD
(Sugama et al., 2012, p. 6). Therefore, yes, the results sufficiently drew a conclusion, and
interpreted the context of the purpose, hypothesis, framework, and literature review.
Question 2
Score
Are the conclusions, generalizations, and limitations clearly stated and within
3
the scope of the findings? Does this study contribute to nursing science?
Rationale for the score value:
The conclusion clearly stated using the test incontinence absorbent pad that incorporates frontal
absorption and a backflow prevention mechanism, a significantly faster, full recovery was
observed among older women with urinary IAD compared with those in the control group using
a conventional pad. Our research suggest good efficacy of the test absorbent pad in facilitating
recovery from IAD (Sugama et al., 2012, p. 6). According to Schmidt & Brown (2015) finding
that multiple studies have obtained similar positive results increases the extent to which one can
generalize or apply findings to a wider population (p. 73). The article references a study that
developed a pad that consisted of an absorbent layer with a specially formulated pH-controlling
fiber and a highly breathable material in the side panel that can maintain a weakly acidic skin
pH (Sugama et al., 2012, p. 6). This study did not have a control group to compare the results
with, which lead to inconclusive data. The limitation is stated on page six, and stated that the
results to do not apply to those who have a sedentary lifestyle, since the study was conducted on
elderly women who are bedridden. This study does contribute to the nursing science, because it
gives evidence of natural healing at a quicker rate while using the test absorbent pad.

References
Schmidt, N. A., & Brown, J. M. (2015). Evidence-based practice for nurses: Appraisal and
application of research (3rd ed). Sudbury, MA: Jones & Bartlett.
Sugama, J., Sanada, H., Shigeta, Y., Nakagami, G., & Konya, C. (2012). Efficacy of an improved
absorbent pad on incontinence-associated dermatitis in older women: cluster randomized

controlled trial. BMC Geriatrics, 12(22), 1-7. doi:10.1186/1471-2318-12-22