Introduction
The rate of childhood cancer has increased in the last
10 years.[] The Turkish Statistical Institute reported
that cancer was the second most common cause of
death in children aged ?5 years, with a rate of 16.4%.
[] Regarding the children between 0 and 14 years of
age suffering from cancer, 35.5% have leukemia.[]
Oral mucositis refers to the inflammatory or ulcerative
lesions in the oral mucosa of patients with cancer
receiving chemotherapy or radiotherapy, which
can turn into intensely painful sores from mild rashes.
[-] Chemotherapy damages the regenerative cells in mucosa and causes saliva to lose its protective feature,
facilitating the development of oral mucositis.[-]
The prevalence of oral mucositis was 42.5% among inpatients
and the admission length was increased with
increasing severity. Patient diagnosis, chemotherapy
treatment block, day of chemotherapy cycle, and neutropenic
status have been shown to influence the risk
of developing oral mucositis.[] Pain, bleeding, ulceration,
mouth dryness, change in taste, and malnutrition
are generally observed in mucositis. The severity
of oral mucositis leads to the tapering or postponement
of chemotherapy and a longer period of hospitalization.[,] Moreover, it may cause skipping or reducing
chemotherapy doses. Therefore, long-term
therapy results may be negatively affected.[]
It is important to assess oral mucositis for preventing
and ensuring its early diagnosis and treatment if
it develops. Easy-to-use, valid, and reliable scales are
needed to assess oral mucosa in children. Scales can be
used to anatomically, symptomatically, and functionally
assess oral mucosa.[,] Pediatric oncology nurses
play a crucial role in evaluating and promoting oral
hygiene and minimizing the potentially debilitating effects
of oral mucositis. Most commonly, nurses make
decisions regarding oral care. The lack of well-tested
and validated instruments also has negative effects on
clinical care. Oral assessment may provide baseline
data; ensure that oral complications are predicted, and
thus prevented or minimized; and enable the evaluation
of nursing interventions.[] A better definition of oral assessment can also s oral status. Structured symptom
assessment results in health professionals experience of
symptoms.[]
The scales that are most commonly used for clinical
assessment of mucositis include functional scales such
as the scale of the World Health Organization (WHO)
and the National Cancer Institute Common Toxicity
Criteria based on the ability to eat and drink. However,
it has been pointed out that WHO and other functional
scales may under-report mucositis if analgesia is given
and is effective.[,] The National Cancer Institute
Common Toxicity Criteria is used to observe the findings
of and determine the severity of oral mucositis by
identifying its effects on eating function.[] Another
scale that can be used to assess oral mucositis is the Oral
Mucositis Assessment Scale.[] Sung et al. reported
that the Oral Mucositis Assessment Scale is valid for use
in mucositis clinical trials for children at s International
Mucositis Evaluation Scale (ChIMES) was developed to
assess oral mucositis in pediatric patients with cancer
and the findings related to mucositis.[] Yavuz et al.
adapted ChIMES into Turkish and tested its validity
and reliability.[]
The Oral Assessment Guide (OAG), developed by
Eilers et al., was considered to be a useful research tool
appropriate for everyday clinical practice use in both
adults and children.[,] Cheng et al.[] reported
that OAG was effective in the oral assessment of 42 children
receiving chemotherapy between 6 and 17 years of
age. Cheng et al.[] administered OAG to 14 children
receiving chemotherapy between 6 and 17 years of age
at the beginning of chemotherapy and twice a week for
the following 3 weeks. They reported that this guide was
effective in developing an oral care protocol.
Gibson et al. modified the original scale at Great
Ormond Street Hospital for Children. Hence, the abbreviation
of this hospital"s name was added to the abbreviation
of the revised scale and the modified scale
was named Oral Assessment Guide for Children and
Young People (GOSH OAG). They found the content
validity index (CVI) of the modified guide to be 0.83.
The fact that this value was >0.80 shows that the scale
has a high validity. Gibson et al.[]reported that the
modified scale was appropriate for children and adults.
The parameters of GOSH OAG enable nurses to examine
oral mucosa in detail. Using a light source for examining
the inside of the mouth ensures early diagnosis of
mucositis.
Two of the scales developed to assess mucositis
in children with cancer were adapted into Turkish:
ChIMES [] and the WHO scale. The Turkish nurses use the WHO scale in clinics to assess mucositis in
children with cancer. However, this scale was found to
be insufficient for clinical practice. The early diagnosis
of mucositis is important for nurses to quickly assess s
oral mucosa in detail. Testing the validity and reliability
of GOSH OAG in Turkish is considered to enable the
nurses to more quickly and accurately assess the oral
mucosa of children with cancer. A new scale is needed
in the clinics in Turkey to diagnose mucositis in children
with cancer at an early stage.
GOSH OAG has not been translated into several
languages yet. No reports were previously put forward
on translation or validation of GOSH OAG into Turkish.
The Turkish nurses need a scale to assess the inside
of the s mouth.
This study aimed to examine whether the Turkish
GOSH OAG was a valid and reliable tool to assess
mucositis and whether it could be used as a clinical research
instrument. This study was conducted to translate
GOSH OAG into Turkish and test the reliability and
validity of mucositis in children with cancer.
Methods
Scale
GOSH OAG was developed by Gibson et al. It is a scale
designed to assess oral status in children following chemotherapy
and/or radiotherapy. GOSH OAG consists of the following eight items: (1) voice, (2) swallow, (3)
lips and edge of the mouth, (4) tongue, (5) saliva, (6)
mucous membranes, (7) gingiva, and (8) teeth.
Each category descriptor is scored from 1 to 3: 1,
normal; 2, mild alterations without severe compromise
of either epithelial integrity or systemic functioning;
and 3, definite compromise. The eight subscale scores
are summed to obtain an overall assessment (minimum,
8; maximum, 24). Higher scores on the scale indicate an
increased risk of mucositis or the actual development of
mucositis. This guide enables to identify the changes in
mucosa at an early stage. GOSH OAG was proven to be
clinically useful to assess, record, and communicate oral
changes in children and young people who underwent
chemotherapy and/or radiotherapy in clinical settings.
CVI of the guide was found to be 0.83, indicating a high
level of validity.[]
Patients, Data Collection, and Statistical Analysis
The study was planned to adapt GOSH OAG into Turkish
language and culture and evaluate the validity and
reliability of the Turkish version. The study was conducted
in the pediatric oncology and hematology unit
of a university hospital in Antalya, Turkey.
According to Esin, the sample size can be taken as
3-10 times the number of items in the inventory.[]
[] In this study, as the scale had eight items, it was administered to a total of 60 people who agreed to participate
in the study. A total of 83 children with cancer
who had been receiving medical therapy in the pediatric
hematology oncology unit between September 2014
and July 2015 were approached and 60 (89.6%) of them
agreed to participate in the study.
All participants were asked to provide informed
consent. A personal data form and GOSH OAG were
completed by each participant. Data were collected by
the authors during face-to-face interviews. A detailed
medical history was obtained for all patients. Information
about diagnosis and treatment was noted from the
medical records. All patients were assessed in the patient
room of the children hematology oncology unit.
Patients were explained the aim and study protocol. The
scales were administered to patients after obtaining their
written consent.
Data Analysis
All the data were entered, checked for missing values,
and analyzed using SPSS version 20.0 (SPSS Inc., Chicago,
IL, USA) statistical programs. Descriptive statistic,
mean, median, frequencies, and percentages were used
to show the distribution of the personal characteristics,
illness-related characteristics, and oral care practices.
Factor analysis was also performed. s alpha and
the Pearson correlation test were used to examine the
internal reliability and validity, respectively. For all statistical
analyses, p<0.05 was considered to be statistically
significant.
Ethics Considerations
Permission to translate and use GOSH OAG into Turkish
was granted by the developer Faith Gibson. Permission
to conduct this study was received from the authors"
institutional ethical committee. The patients were informed
about the purpose of the study and what should
be expected from them. Participants were assured of the
rights of refusal to participate in or to withdraw from the
study at any stage without any negative consequences.
The anonymity and confidentiality of participants were
guaranteed.
Results
Demographic and Clinical Characteristics
A total of 60 children with cancer were interviewed
in this study. The demographic and clinical characteristics
of the participants were examined. The average age of the children was 11.47 years [standard deviation
(SD)=3.14; range=8-18]. Of these children, 38.3% were
females and 61.7% were males. A majority of the participants
had leukemia (55.0%). The average duration of the
illness was 11.64 months (SD, 18.16 months), average
duration of treatment 11.66 months (SD, 18.15 months), and average duration of chemotherapy 23.20 days (SD,
22.69 days) (Table 1).
Table 1: Demographic and medical characteristics of
the children with cancer (n = 60)
All children who participated in this study were continuing
their oral treatment in the hospital. It was found
that 47.1% of the children were administered nystatin
(Fungostatin oral suspension)+benzidamine hydrochloride (Tantum Verde oral spray)+sodium bicarbonate
ampule daily (Table 2). The frequency of daily oral care
provided to the children receiving chemotherapy (Fig.
1).
Table 2: Demographic and medical characteristics of the children with cancer (n = 60) Oral care
Fig 1: Frequency of administration of the oral care methods in children with cancer.
Internal Consistency of the Turkish GOSH OAG
GOSH OAG was tested for internal consistency and
inter-rater reliability. s alpha internal consistency coefficient
was found to be 0.84 in this study. The Cronbach"s
alpha internal consistency coefficient of the Turkish
GOSH OAG was found to be between 0.79 and 0.84 for
children with cancer, indicating a satisfactory reliability
(Table 3).[]
Table 3: GOSH OAG item total score correlations and
Cronbach alpha coefficients
Construct Validity of the Turkish GOSH OAG
CVI for each item of GOSH OAG according to the
evaluation of the seven experts. CVI ranged from 0.86
to 1.00, demonstrating that the items of GOSH OAG
highly contributed to the measurement of the oral cavity
Angelo et al.[], CVI of each item descriptors in OAG
was also calculated (Table 4).[]
Table 4: Respondent CVI score for content validity entire instrument
Criterion Validity/ Concurrent Validity
The criterion validity of the Turkish GOSH OAG was
determined through item analysis based on differences
between mean scores of upper-lower group items. Statistically
significant differences were found between
the mean scores of the upper and lower group items
(t=-17.61, p=0.000) (Table 5). Item analysis showed
that GOSH OAG had a concurrent validity and could be
used to assess inside and around the mouths of children receiving chemotherapy against the risk of oral mucositis.
Table 5: GOSH OAG simultaneous validity
Mean Scores of Children with Cancer on GOSH OAG
The mean score of children with cancer on the scale was
1.63±0.52 on the items scored between 1 and 3. The children
obtained the lowest mean score on the gingiva item
(1.37±0.64) and the highest mean score on the tongue
item (1.85±0.63) (Table 6).
Table 6: Mean scores of the children receiving cancer
on GOSH OAG
Discussion
GOSH OAG was first tested for language validity. Language
validity criterion was ensured for OAG. The scale
was translated by two academic members and two specialists
who were fluent in Turkish and English languages.
s ability to accurately measure a feature or variable
that it aims to measure s validity is affected by objectivity,
distinctiveness, comprehensiveness, easiness to use,
and scorability.[] Generally, three types of validity exist:
content validity, criterion validity, and construct validity.
This study tested the content validity of OAG. Item
and scale validity indices were used for content validity.
The opinions of seven experts were obtained to test and
evaluate the content validity of GOSH OAG. A consensus
was found among the experts regarding the applicability
of the items of the scale.[-]
s alpha coefficient was used to determine the reliability
of GOSH OAG. The s alpha coefficient is a criterion
for internal consistency of scale items. Higher s
alpha coefficient indicates higher consistency between
the items of a s alpha coefficient of GOSH OAG was
found to be 0.84 in this study. Gibson s alpha coefficient
of GOSH OAG to be 0.84 in their study.[] The result of
this study was similar to the results obtained by Gibson
et al. This study showed that the Turkish GOSH OAG
was highly reliable.
It also analyzed the total-item correlation for reliability
analysis of GOSH OAG. An acceptable coefficient of
?0.30 was recommended for the interpretation of totalitem
correlation.[] The total-item score coefficients of
OAG were found to be positive and strong in this study,
ranging between 0.43 and 0.80.
All experts in this study agreed on the importance of the
eight categories of GOSH OAG, which was confirmed
by the high score of CVI per item, ranging from 0.85 to
1.00. The experts also appreciated the scale for its clarity,
wording, efficiency, and simplicity. This is essential
for an instrument to be used in clinical practice and research.[] In the original CVI to be high (ranging from 0.78 to 1) [], which was in parallel with the finding of
this study.
All items of the Turkish scale sufficiently correlated
with the total score and had a high level of item reliability.
Total-item score analysis was also accepted as an indicator
of validity. It also reflected the construct validity
of the scale.[,]
The literature includes a limited number of studies
that aim to develop oral assessment scales for children
with cancer who receive chemotherapy.[,,,]
Only one study is available in Turkey regarding the oral
assessment scales for children with cancer who receive
chemotherapy.[] With the verification of the validity
and reliability of GOSH OAG, an important assessment
tool was introduced in Turkey for oral assessment aimed
at children with cancer.
Limitations of the Study
A total of 83 patients who met the inclusion criteria were
included in the study; 23 patients did not agree to participate.
The major reasons for refusing to participate in
the study were as follows: (1) too weak to be interviewed,
(2) lack of interest, and (3) wish to withdraw from the
study during the data collection using a video camera .
Conclusion
The Turkish GOSH OAG showed statistically acceptable
levels of reliability and validity. Based on psychometric
properties, the Turkish GOSH OAG was proven to be a
culturally appropriate tool for children with cancer.
Turkish researchers and health care providers can
use GOSH OAG to assess mucositis in children with
cancer. These are relevant characteristics for the possible
use of this simple, applicable questionnaire in assessing
patients with cancer who need additional medical
management. The authors of this study believed that this
instrument would become useful in the future cross-cultural
studies on children with cancer. Studies examining
the validity of this tool for longitudinal data from clinical
samples should be conducted with a larger sample
size, including people from different regions in Turkey
and diverse populations around the world.
Relevance to Clinical Practice
Valid measurement instruments are needed to assess
mucositis in patients with cancer. Turkish researchers
and health care providers can use GOSH OAG, an easyto-
use tool, to assess mucositis in children with cancer.
GOSH OAG will enable nurses to assess mucositis in
children with cancer.
Disclosures Statement
The authors declare that they have no conflict of interests.
Acknowledgments: The authors wish to thank the authors
of GOSH OAG for their permission to translate
and use the guide. The authors are especially grateful
to all pediatric patients with cancer who participated
in this study. They also wish to thank all experts for
translation and back-translation and for conceptual and
content identification. They are also grateful to Prof. Dr.
Mehmet Ziya Fırat for statistical consultation. This study
has been produced from the Master"s thesis and received
no financial support for the research and/or authorship
of this article.
Ethics Committee Approval: This study was conducted inaccordance
with local ethical rules.
Peer-review: Externally peer-reviewed.
Conflict of Interest: None declared.
Authorship contributions: Concept ? E. E, Ş. Ç; Design ? E.
E, Ş. Ç; Supervision ? E. E; Materials ? Ş. Ç; Data collection &/
or processing ? Ş. Ç; Analysis and/or interpretation ? E. E, Ş.
Ç; Literature search ? Ş. Ç; Writing ? E. E, Ş. Ç; Critical review
? E. E, Ş. Ç
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