Design and psychometric properties of a questionnaire for assessing sexual and reproductive health needs of married adolescent women: an exploratory sequential mixed methods study

Abstract To date, there is no valid and reliable instrument to specifically evaluate married adolescent women's sexual and reproductive health (SRH) needs. Hence, the aim of this study was to develop and evaluate the psychometric properties of a questionnaire for assessing married adolescent women (MAW)'s SRH needs. The current exploratory sequential mixed method study was performed in two phases. In the first phase, a preliminary questionnaire was developed based on in-depth interviews with 34 MAW and four key informants as well as a comprehensive literature review. In the second phase, validity of the questionnaire was assessed using face, content, and construct validity and reliability of the questionnaire was assessed using internal consistency and test–retest reliability. Based on qualitative content analysis and literature review, 137 items were extracted. After several modifications of the generated items, a 108-item questionnaire was prepared for the psychometric process. After checking face and content validity, 85 items remained in the study. In the exploratory factor analysis, 11 items were removed and the remaining 74 items were categorised into nine factors. Cronbach's alpha coefficient and the intraclass correlation coefficient were found to be 0.878 and 0.99 for the whole scale, respectively. Impact Statement What is already known on this subject? Sexual and reproductive health (SRH) needs of married adolescent women (MAW) are different from those of married adult women or unmarried, sexually active adolescents. However, there are to date no valid and reliable instruments to specifically evaluate the SRH needs of this group of women. What do the results of this study add? The final version of questionnaire consists of 74 items in nine domains including need to improve MAW's sexual quality of life, promote MAW's SRH self-care, improve MAW's SRH self-efficacy, increase MAW's SRH knowledge, increase husband's involvement in MAW's SRH, improve the performance of health care providers, strengthen the family support to married adolescent women, improve family involvement in SRH education of MAW, and provide specific premarital counselling to MAW. What are the implications of these findings for clinical practice and/or future research? The 74-item questionnaire has acceptable validity and reliability. Therefore, it can be used by researchers and policymakers as an appropriate instrument for assessing MAW's SRH needs.


Introduction
Despite widespread efforts to end child marriage, about 1 in 3 girls in the developing countries marry before age 18 and 1 in 9 marry before the age of 15 (1,2). If current levels of child marriages hold, the total number of women married in childhood will grow from more than 700 million today to nearly 1.2 billion by 2050 (3). Child marriage is associated with suboptimal reproductive health (4). Married adolescent women start childbearing earlier, give shorter birth intervals, and report having more unwanted pregnancies than their peers who marry later (5). They are also more likely to have limited access to, and use of, contraception, and other maternal healthcare services compared to adult peers (6). These factors put them at higher risk of pregnancy complications, which are the leading cause of death among adolescent girls in developing countries (7).
Married adolescent women have also higher risk of HIV infection and other sexually transmitted infections, and are more likely to experience intimate partner violence, than unmarried, sexually active girls or women who marry later (8,9). Further, babies born to adolescent mothers are at higher risk of preterm birth, low birth weight, stillbirth and neonatal mortality (10,11). Yet, despite their large numbers, increased risk of pregnancy complications, and many unmet needs, little is known about the sexual and reproductive health (SRH) needs of married adolescent women. Awareness of SRH needs of married adolescent women is critical for developing interventions to reduce the negative health consequences of child marriage. Evidence suggests that the SRH needs of married adolescent women are different from those of married adult women or unmarried, sexually active adolescents (12). However, to the best of our knowledge, there are to date no valid and reliable instruments to speci cally evaluate the married adolescent women's SRH needs. Hence, the purpose of this study was to design and evaluate the psychometric properties of a questionnaire for assessing SRH needs of married adolescent women in Iran.

Methods
This sequential, exploratory mixed methods research had two phases: Descriptions of these are provided as follows: Phase 1: Item generation and questionnaire development A conventional qualitative content analysis was designed to determine the concept and dimensions of the married adolescent women's sexual and reproductive health needs. The research was conducted from November 2017 to June 2018 in Mashhad city (healthcare centers) and Shahrood County (a maternity teaching hospital and urban/rural healthcare centers), Iran. Data were collected using semi-structured, in-depth interviews with 34 married adolescent women and 4 healthcare providers. In the interviews, married adolescent women were asked the following questions: "What does sexual and reproductive health mean to you?"; "What are the sexual and reproductive health needs of married adolescent women?"; "What are the barriers and challenges faced by married adolescent women in accessing and utilizing reproductive health services?"; "Have you ever experienced such challenges?"; "What major challenges did you face, and how did you handle them?".
Healthcare providers were asked the following interview questions: "What are the sexual and reproductive health needs of married adolescent women?"; "What are the barriers and challenges faced by married adolescent women in accessing and utilizing reproductive health services?". Each interview lasted between 30 and 80 min. All interviews were audio-recorded with the participants' permission and transcribed verbatim for analysis. MAXQDA software (Version 10) was used to facilitate data management.
Then, the following databases were searched for relevant papers: Web of Science, PubMed/Medline, Scopus, and Science Direct. Google Scholar was also searched for any pertinent studies that may not have been found in the database search.
Extracted codes from the interviews and a review of the literature led to an initial questionnaire with 137 items.
After several modi cations of the generated items, a 108-item questionnaire was prepared for the next stage.
Phase 2: Psychometric properties of the questionnaire In this phase, the validity (face, content and construct validity) and reliability (internal consistency and testretest reliability) of the designed questionnaire were assessed. Details are as follows:

Face validity
Qualitative and quantitative methods were used to determine face validity. In qualitative assessment of face validity, 10 married adolescent women were recruited using convenience sampling to determine complexity, relevance, and ambiguity of the items. Then, the items were modi ed according to the married adolescent women's viewpoints.
For quantitative face validity assessment, the same adolescent women rated the importance of each item on a 5-point Likert scale. Then, the impact score for each item was calculated using the following formula: (frequency (%) × importance). Frequency re ects the percentage of raters who scored a score of 4 or 5, and importance re ects the mean score for the importance of each item. Items with an impact score of greater than or equal to 1.5 (which corresponds to a mean frequency of 50% and a mean importance of 3 on the 5-point Likert scale) were considered appropriate (13).

Content validity
For analyzing qualitative content validity, 10 experts in the elds of midwifery and reproductive health were requested to assess grammar, wording, item allocation, and scaling of the questionnaire. Then, items were amended based on their comments.
Quantitative assessment of content validity was done by calculating content validity ratio (CVR) and content validity index (CVI).
To determine CVR, the same ten experts were asked to score each item on a 3 -point Likert scale: 1 = not essential; 2 = useful, but not essential; and 3 = essential. The CVR for each item was calculated using the following formula: CVR = (ne -(N/2)) / (N/2). In this formula N is the total number of experts and ne is the number of experts that rated the item as essential. According to Lawshe's table, items with a CVR greater than or equal to 0.62 were retained (14). For calculating CVI, the same ten experts were asked to rate each item based on relevance, clarity, and simplicity on a 4-point Likert scale (rating from 1[not relevant/ not clear / not simple] to 4[highly relevant/ highly clear/ highly simple]) (15). The CVI was calculated for individual items (I-CVI) and the overall scale (S-CVI). The I-CVI was calculated as the proportion of experts who rated the item as 3 or 4 (16). The S-CVI was calculated as the average value of all the I-CVI values (16). Content validity indexes were considered acceptable when I-CVI and S-CVI were at least 0.78, and 0.90, respectively (16, 17). To counter the limitations of CVI, each I-CVI was adjusted for chance agreement by calculating the modi ed kappa statistic

Construct validity
Exploratory factor analysis (EFA) was performed in order to assess the construct validity of the questionnaire.
The required sample size for conducting EFA is 3-10 subjects per item (19). Therefore, for 85-item questionnaire, a sample size of 85 × 3 = 255 was estimated; however, in practice 248 married adolescent women participated in the study and completed the questionnaire. Census method was used to recruit subjects from urban/rural healthcare centers in Shahrood County and Miami County of Semnan province, northeast Iran (July to November 2020). The inclusion criteria were: having Iranian nationality; being 10 to 19 years old; being married; living in Shahrood County or Miami County; given birth to ≥ 1 child or being pregnant with a gestational age of ≥ 20 weeks; and willingness to participate in research. Married nulliparous adolescents (who had never been pregnant or had never carried a pregnancy beyond 20 weeks) were not included in the study.
Kaiser-Meyer-Olkin (KMO) was used for checking sampling adequacy and Bartlett's test of sphericity was used to examine the appropriateness of data for factor analysis. The KMO value should be greater than 0.5 and result of Bartlett's test of sphericity should be statistically signi cant with a p value less than 0.05 (20). Principal components analysis (PCA) with varimax rotation was conducted to extract the underlying factors (21). Factor loadings greater than or equal to 0.3 were considered appropriate (22). The number of factors was extracted based on eigenvalues greater than 1 and then see the scree plot. All statistical analyses were performed using SPSS software, version 22.0 (SPSS Inc., Chicago, IL, USA).

Internal consistency
The internal consistency for each dimension and the entire scale was assessed using the Cronbach's alpha coe cient. Values equal to or greater than 0.7 were considered acceptable (23).

Test-retest reliability
In order to assess test-retest reliability, 20 subjects completed the questionnaire twice with a 2-week interval.

Ethics
The study protocol was approved by the Ethics Committee of Shahroud University of Medical Sciences with the ethical code: IR.SHMU.REC.1396.69. All subjects gave informed consent prior to participation in research. The preliminary questionnaire consisting of 137 items was developed according to the extracted codes from qualitative study (135 items) and a comprehensive literature review (2 items). After careful review of the items by the research team, the number of items was reduced to 108. Seventy-nine of the items were rated on a 5point Likert scale ranging from 1 (strongly disagree, not at all, never) to 5 (strongly agree, very much, always), and 29 were placed on a 3-point Likert scale (1 = correct, 0 = incorrect and I do not know). Eighteen items were negatively worded.

Results
Phase 2: Psychometric properties of the questionnaire

Face validity
In qualitative face validity, six items were modi ed and three were merged into each other based on married adolescent women's suggestions. Then, in quantitative face validity, eight items were deleted due to their impact score of less than 1.5.

Content validity
In qualitative assessment of content validity, twenty-six items were modi ed and two were merged into each other based on experts' recommendations. In the quantitative assessment of content validity, twelve items with a CVR of less than 0.62 were deleted. All remaining 85 items had an excellent content validity (I-CVI ≥ 0.78, κ* ≥ 0.74). The average scale content validity (S-CVI/Ave) was 0.94.

Construct validity
For exploratory factor analysis, 248 married adolescent women completed the 85-item questionnaire.
The Kaiser-Meyer-Olkin index (0.716) and Bartlett's test of sphericity (χ² = 4803.455, df = 2145, p < 0.001) indicated that the sampling was adequate for EFA. The results of the PCA with varimax rotation indicated an initial thirty-factor solution with eigenvalues greater than 1 that accounted for 69.06% of the total variance. However, due to the large number of factors and the uninterpretable results, the scree plot was used to determine the number of factors (9). The scree plot showed that the major variance was related to the rst nine factors (Figure 1). Factor analysis with nine constant factors was repeated with varimax rotation.
The nine factors explained 34.71% of the observed variance.
As shown in Table 1, eleven items that were not loaded on any of the factors were excluded from the questionnaire, whereby the questionnaire was reduced to 74 questions. Subsequently, each factor was named according to its items. factor 1: need to improve married adolescent women's sexual quality of life (13 items); factor 2: need to promote married adolescent women's SRH self-care (8 items); factor 3: need to improve married adolescent women's SRH self-e cacy (6 items); factor 4: need to increase married adolescent women's SRH knowledge (18 items); factor 5: need to increase husband's involvement in married adolescent woman's SRH (9 items); factor 6: need to improve the performance of health care providers (6 items); factor 7: need to strengthen the family support to married adolescent women (8 items); factor 8: need to improve family involvement in SRH education of married adolescent women (3 items); and factor 9: need to provide speci c premarital counseling to married adolescent women (3 items).

Internal consistency
The Cronbach's alpha coe cient for the entire instrument was .878 and ranged from .704 to .809 for its subscales, all of which re ect acceptable internal consistency. Therefore, no items of the scale were omitted in this phase. The results are shown in Table 2.

Test-retest reliability
The intraclass correlation coe cient (ICC) was .99 for the entire instrument and ranged from .97 to 1 for its subscales, lending support for the stability of the questionnaire. The results are shown in Table 2.

Scoring
The nal questionnaire consists of 74 items divided into nine separate domains. The score of items related to the domain of 'need to increase married adolescent women's SRH knowledge' has a two-point Likert scale (1 = correct, 0 = incorrect and I do not know). The items of other eight domains are rated on a ve-point Likert scale ranging from 1 (strongly disagree, not at all, never) to 5 (strongly agree, very much, always). Nine negatively worded items in the questionnaire are reverse scored, including three items in factors 1 and 9, two items in factor 5 and one item in factor 6.
To convert raw scores into standard scores, the following conversion formula was used: Transformed scale = [(actual raw score-lowest possible row score) / possible row score range)] × 100 Where, 'actual raw score' is the values achieved through summation, "lowest possible raw score" is the lowest possible value that could occur through summation, and "possible raw score range" is the difference between the maximum possible raw score and the lowest possible raw score.
Using this formula, each subscale is scored on a scale of 0 to 100, with higher scores indicating fewer unmet need.
The total score of the questionnaire is computed using calculating the average of the total modi ed scores of the questionnaire. Higher scores in the entire questionnaire represent fewer unmet need for sexual and reproductive health.

Discussion
The aim of this exploratory sequential mixed methods study was to develop and evaluate the psychometric properties of a questionnaire for assessing married adolescent women's sexual and reproductive health needs, called the MAWSRHNAQ. To our knowledge, the MAWSRHNAQ is the rst psychometrically tested scale available for assessing married adolescent women's SRH needs. The initial questionnaire was developed based on in-depth interviews with married adolescent women and key informants as well as a comprehensive literature review. Results from the psychometric assessment indicated that the scale has an acceptable validity and reliability. The results of face validity showed that the words and phrases used in the MAWSRHNAQ are easy to understand by the target population. Moreover, the content validity of the instrument was con rmed by a panel of experts. The construct validity of the questionnaire was performed using EFA. The Cronbach's alpha of the questionnaire was 0.878; indicating acceptable internal consistency and test-retest reliability of the questionnaire was excellent, with an ICC of 0.99. After completing the validity and reliability stages, the nal version of questionnaire consists of 74 items in 9 domains: need to improve married adolescent women's sexual quality of life, need to promote married adolescent women's SRH self-care, need to improve married adolescent women's SRH self-e cacy, need to increase married adolescent women's SRH knowledge, need to increase husband's involvement in married adolescent woman's SRH, need to improve the performance of health care providers, need to strengthen the family support to married adolescent women, need to improve family involvement in SRH education of married adolescent women, and need to provide speci c premarital counseling to married adolescent women.
Some limitations of this study should be mentioned. First, subjects were recruited from two counties in the northeast Iran, which may limit generalizability of our ndings to other regions. Another limitation is the sample size, which was the minimum required for factor analysis and not relatively large. The other limitation is the long length of the questionnaire, which might have led to participants' boredom and could have in uenced the accuracy of the participants when completing the questionnaire. A further limitation of the current work is lack of comparable valid and reliable instruments in the literature. In addition, the possibility of response bias is an inherent problem with any self-report measure. Our research also has some strengths. The questionnaire is developed based on the experiences of target group and a comprehensive literature review. Selection of married adolescent women from urban-rural areas is other strength. Another strength of this study is utilizing a mixed methods sequential explanatory research design. Moreover, the psychometric properties of the questionnaire were assessed through analyses of its face, content, construct validity, internal consistency, and stability.

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The MAWSRHNAQ scale lls a gap in the literature, given the lack of sexual and reproductive health needs assessment tools for married adolescent women. This valid and reliable instrument can be used by researchers, and policymakers to assess married adolescent women's SRH needs before and after design and develop speci c interventions for improving SRH status of this group of women. However, further modi cations and psychometric testing of this new instrument should be performed before using it in different cultural contexts. In the pre-marriage counseling program, sexual and reproductive health issues should be taught in several sessions.

0.409
In pre-marriage counseling classes, sexual and reproductive health content is taught insu ciently.

0.387
It is necessary to hold a special pre-marriage counseling training class for teenagers.

0.362
If in the pre-marriage counseling classes, in addition to group education, the conditions for couple education were provided, the possibility of understanding of the subject taught would be increased.  Figure 1 Scree plot.