Study design and setting
A cross-sectional study was conducted in all women who attended the gynecology outpatient clinics in Riyadh’s four main hospitals (King Khaled University, Alyamamah, King Saud Hospital, and the King Fahad Medical City) and primary care centers in Riyadh that were randomly selected by sectors as defined by the ministry of sectoral health division. Two primary care centers from each sector (North, South, Center, East, and West) were selected (for a total of 10 primary care centers).
Sample size
We used the electronic sample size calculator, the openEpi software, to determine the required sample size. The equation used for this calculation is given below:
$$ \mathrm{n}=\left[{\mathrm{DEFF}}^{\ast}\mathrm{Np}\left(1-\mathrm{p}\right)\right]/\left[\right(\mathrm{d}\ 2/\mathrm{Z}\ 2\ 1-\upalpha /{2}^{\ast}\left(\mathrm{N}-1\right)+{\mathrm{p}}^{\ast}\left(1-\mathrm{p}\right)\Big] $$
n = required sample size
(N: Population size(for finite population correction factor or fpc) (1000000))
(p: Hypothesized % frequency of outcome factor in the population (50%+5))
(d: Confidence limits as % of 100 (absolute + 5%))
Design effect (for cluster surveys-DEFF): 1
z= confidence level at 95% (standard value of 1.96)
m = margins of error at 5% (standard value of 0.05)
sample size = 385; the expected non-response rate was set at 20%
Total sample size: 450
Sampling technique and study subjects
The investigator collected the data from January 15, 2018 to February 30, 2018. Participants were selected randomly as follows: 150 women from the King Khalid University Hospital, 150 from the Ministry of Health Hospitals (50 from each hospital), and 150 from primary care centers (30 from each sector).
The inclusion criteria were: Saudi women (1), aged 18 years or older (2) not diagnosed with gynecological cancer, and (3) agreed to participate in the study.
Data collection
A predesigned self-administered questionnaire was composed according to the findings from three validated published studies that were conducted in Turkey, Egypt, and Alahsa (Saudi Arabia). Furthermore, CHBM components were added to the questionnaire after obtaining permission from the copyright owner [19, 22, 23]. This self-administered questionnaire includes questions about the following topics: (1) socio-demographic characteristics; (2) knowledge about cervical cancer and about the Pap smear test; (3) HPV)-related questions; and the (4) HBM scale for cervical cancer and for the Pap smear test. The following section describes the various parts included the in the questionnaire and the topics covered in each part:
Part I
Socio-demographic characteristics such as age, area of residence, educational status, working status, marital status, age at marriage, duration of marriage, number of living children, usage of hormonal contraception, smoking, and family history of cervical cancer.
Part 2
Knowledge about cervical cancer and about the Pap smear test (yes, no, and I do not know options for being familiar with the Pap smear test; the source of information about the Pap smear test; knowledge about the Pap smear test being the main cervical cancer screening test; knowledge that cervical cancer is the most frequent cancer among women; yes and no options for whether the participant had undergone a Pap smear test; knowledge about the appropriate age at which women require a Pap smear test). Possible signs of cervical cancer were queried in 10 items (weight loss, blood in the stool or urine, vaginal bleeding after the menopause or after having sexual intercourse, pain during sexual intercourse, heavy of prolonged menstrual periods, persistent vaginal bleeding or discharge, pelvic pain and lower back pain) with “yes”, “no”, and “I do not know” options. Correct responses for possible signs were assigned a score of one point while the responses “No” or “I do not know” were assigned zero points.
The possible risk factors of cervical cancer were queried using 8 items (HPV status, smoking, weakened immunity, use of contraceptive pills, history of Chlamydia infections, marriage at a younger age, having many children, and not undergoing Pap smear tests regularly) using 5-point Likert-type scale options (strongly disagree (1 point) to strongly agree (5 points)). One item was removed from the original form from the risk factors section (having many sexual partners), since it is a sensitive question in view of the conservative nature of the Saudi society.
Part 3
Assessing the uptake of HPV vaccination with “yes,” “no,” and “I do not know” options. The reasons for not obtaining the vaccination and age of vaccination were also queried. The internal consistency measure (Cronbach’s alpha) of the modified instrument was 0.784 for knowledge of cervical cancer and the HPV vaccine (all items), 0.86 for the signs and symptoms section (10 items), and 0.69 for the risk factors section (eight items), as revealed by pilot testing.
Part 4
Using the HBM scale for cervical cancer and the Pap smear test. The scale was used based on Victoria Champion CHBM scale. The format, content, and validity of scale were tested and used in different language and culture. Permission was obtained from Champion to adapt the scale and to make the necessary changes to render them in order to be valid for both Arabic language and culture. This scale has five subscales: Perceived susceptibility to having disease was assessed by using three items “It is likely that I will get cervical cancer in the future”, “My chances of getting cervical cancer in the next few years are high”, and “I feel I will get cervical cancer sometime during my life.”; perceived seriousness of cervical cancer was assessed by seven items, e.g., “ Problems I would experience with cervical cancer would last a long time.” Perceived benefits of undergoing a Pap smear test were assessed by eight items, e.g., “Having regular Pap smear Tests will help to detect changes to the cervix before they turn into cancer.” Perceived motivation toward improving health was assessed using three items, e.g., “I eat well-balanced meals for my health.” Perceived Pap smear test barriers were evaluated using 18 items, e.g., “I am afraid to have a Pap smear Test for fear of a bad result.” All items of the subscales have the following five-point Likert-type response choices: strongly disagree (1 point), disagree (2 points), neutral (3 points), agree (4 points), and strongly agree (5 points). Each of the subscales was assessed separately, and the total score was not calculated. Subscale scores were calculated for each participant. Higher scores indicate stronger feelings about that construct. All subscales had positive responses related to the screening behavior, except for barriers which are negatively associated. In the original test, Cronbach’s alpha coefficients for the five subscales were observed to fall between 0.62 and 0.86. In this study, Cronbach’s alpha coefficients of 0.89 were observed for the five subscales.
The English questionnaires were translated by two language experts into Arabic and were back-translated to English by two different independent language experts according to Beaton-recommended guidelines [24]. This questionnaire was reviewed by two family physicians, two gynecologists, and one community professor. All the above reviewers are academic experts in their respective fields.
Pilot study
Prior to the main study, the author conducted a pilot study with the questionnaire in 40 women to check the applicability and clarity, and to identify any difficulties with the questionnaire; the pilot study was also employed to ensure the cultural and scientific appropriateness of the instrument for the Saudi community, as well as to estimate the time needed to fill out the questionnaire. The questionnaires take approximately 15–20 min to fill out. Modification of the questionnaire was performed according to the results of the pilot study. Women who participated in the pilot study were excluded from the main study.
Data management
Data were analyzed using the SPSS 21.0 software (SPSS Inc., IBM, USA). The socio-demographic characteristics and knowledge of cervical cancer in participating women are reported as mean, median, number, and percentage distribution, as appropriate. The average score on the HBM Scale for cervical cancer and that for the Pap test (reported as numbers, percentage, and median) were analyzed by parametric (independent sample t-test) and non-parametric tests (Kruskal Wallis test). Correlation analysis (analysis of variance test) was used to determine the relationship between socio-demographic characteristics, knowledge of cervical cancer, and the HBM scale for cervical cancer and the Pap smear test. P values < 0.05 were accepted as statistically significant.