Development and Validation of A Decision-Making Donor Conception Questionnaire in Iranian Infertile Couples

Advances in assisted reproductive technology (ART) offer new methods of getting pregnant and make parenthood possible for people deprived of having children for various reasons (1). Although these technologies are a ‘marriage saver’ for those left without a child (2), give hope to millions of infertile couples (3, 4) and help them to realize their dream of raising a family (5), not all infertile couples use reproductive technologies (6) and the demand for these treatments is unexpectedly low (7). In fact, only half of infertile couples around the world seek treatments (7, 8). Deciding whether or not to use these technologies is definitely difficult (9), and many sociocultural, ethical, legal and religious challenges surrounding different aspects of ART, such as donor conception, can affect the practical use of these technologies (3, 4).

Deciding to use these technologies is influenced by people’s perceptions and the society’s expectations and attitudes toward their use (6). In other words, sociocultural beliefs affect couples’ tendency toward using these methods (10, 11) and influence the rate of employment of these technologies by couples (12). Infertile couples who have a child born through donor conception, experience great prejudice not only by the society but also by their family, relatives and friends. In developing countries, the family’s rejection and social pressures are among the factors affecting the decision about seeking a method of treatment and the choice of treatment is made under the heavy influence of family members (13). Many infertile couples suffer from the stigma of infertility and seeking treatment, and try to keep their condition a secret (14). They feel that they will be ethically judged for their infertility and their decision to use ART (15). The individual’s beliefs and attitudes may be the most important determinant of his/ her actions. Individuals with strong spiritual beliefs and specific sociocultural beliefs may adopt approaches and treatment methods that are different from those adopted by other infertile individuals, and their use of donor conception is also influenced by different factors, as they attribute different meanings to their condition and its treatment and interpret them differently (16). Some infertile couples for whom donor conception is the only way of becoming parents, they might prepare themselves for a childless life or accept to adopt a child and reject medical treatments. Some others, in contrast, try all the available treatments in different medical centers and greatly invest for this goal both in material and emotional terms (17). Sociocultural beliefs may also affect people’s religious beliefs (18). In other words, cultural factors can reinforce or inhibit religious attitudes toward the use of ART. Religion also plays a major role in the use of ART, as it affects people’s views and social norms. It is difficult to have access to ART in countries with religious dogmatism (2). The decision on the employment of ART is made according to the laws of the society (19). Laws have a significant effect on the access to ART (2). In some countries, donation is a process, while in others, there are limited rules. In New Zealand, embryo donation is a key process that is based on rules and policies (20), while in Australia, there are few rules about the donation process (21). Laws are largely based on the sociocultural state of the society and its ethical, spiritual and religious values (19, 22). The limited number of donors is also one of the main practical factors affecting most couples’ decision about the selection of a donor (23). Economic issues also affect the access to ART (24).

Deciding about the use of donor conception services is therefore a complicated and difficult process for couples which challenges their values and beliefs. Making this decision is a complicated social and interactive process that is under the influence of various individual, social, economic, cultural, psychological and ethical factors and is affected by the couple’s interactions with each other and with their family, friends, health workers, key people, etc. It is therefore necessary to develop a scale for identifying the determinants of infertile couples’ decision about using donor conception to perform supportive interventions that improve the decision-making process and reduce the outcomes of the decision including regret. A review of the literature did not show any instruments developed for direct measurement of the subject in question. Given the complexity of the decision-making process about this issue and the absence of an instrument for its assessment, the present study was conducted to fill the gap, develop a decision-making for donor conception questionnaire (DMDCQ) and determine its psychometric properties in Iranian infertile couples.

The scale developed in this study measures the determinants of infertile couples’ decision-making and can help specialists to understand the issues around infertile couples’ decision making concerning the use of ART and design individual and public training programs and instructional decision-making packages for resolving the barriers and thus reducing the need for unnecessary interventions.

This cross-sectional validation study was performed using the method developed by DeVellis in 2012 (25) in four steps, after combining some of the stages:

A total of 220 infertile men and women who met the inclusion criteria participated in this psychometric assessment. Table 1 presents the demographic and infertility characteristics of the participants.

Based on the results of the qualitative content analysis, an item pool was composed of 170 items, and the ambiguous and repetitive items were removed after the revision done by the research team. Eventually, 113 items were developed in five dimensions or constructs, including being offered to use donor conception (ten items), inner turmoil (four items), attempts for coping with the current conditions (23 items), deciding to accept and use donor conception (54 items) and deciding to undergo treatment (22 items), which entered the psychometric assessment phase. The evaluation of face validity, which was performed qualitatively and quantitatively, led to the removal of eight items, and the questionnaire entered the content validity evaluation stage with 105 items. The content validity was also evaluated both qualitatively and quantitatively and 28 items were removed, leading to the existence of 77 items. In the stage of initial reliability evaluation, the Cronbach’s alpha was calculated separately for each item, eight items were removed, and the remaining 69 items entered the construct validity evaluation stage. It should be noted that the questionnaire’s reliability increased to over 0.7 once these items were removed, and according to the researcher, their removal did not destroy the basic information required. The initial Cronbach’s alpha calculated for the entire scale was 0.82.

To determine the construct validity of the scale, 220 participants were selected through convenience sampling to complete the questionnaire. There was no sample dropout. The collected data were entered into SPSS-22. The PCA showed that the correlation between two of the items and the other items was <0.3; thus, both of these items were removed and the factor analysis was continued with 67 items. The KMO measure for the items was 0.768, which indicates the sampling adequacy. The Bartlett's test of sphericity showed the fit of the data for the factor analysis with P<0.001. The community statistic was >0.4 for most of the items in this study and the items were thus considered fit for factor analysis. Five items with a community statistic <0.4 were excluded from the study, and the factor analysis was continued with 62 items. Determining the number of factors constructing the questionnaire using the factor analysis of the items led to the identification of seven factors with eigenvalues >2 and explaining 48.796% of the total variance. The items were rotated and categorized in each factor using a varimax rotation. Of the 62 items that entered the factor analysis in this study, 51 items and seven factors remained.

The factors were named based on the meaning of their items, especially the meaning of the item with the maximum factor loading, and with regard to the correlation found between the items and the available theoretical knowledge. The researcher referred to the qualitative part of the study and the categories and subcategories forming each item, in order to name the factors (Table 2).

Table 3 summarizes the number of items in each subscale and the range of scores for the entire DMDCQ and its subscales.

Table 4 summarizes the mean and standard deviation of the total and subscale scores of the DMDCQ in the entire sample of participants. When the total score of the questionnaire and the scores of its subscales are higher, higher numbers of individuals make positive decisions and the couple will be more inclined toward donor conception in the future.

The initial Cronbach’s alpha was 0.82 for the entire scale and 0.75-0.87 for each subscale. The ICC was >0.7 for all the factors, which confirms the high reliability of the questionnaire (Table 5).

The questionnaire developed in this study is the first and only valid and reliable scale developed and psychometrically assessed in the world, concerning donor conception decision-making. The questionnaire consists of 51 items within seven factors, including the role of social networks, coping strategies, the decision to disclose or conceal, interpersonal relationships, religious quests, donor’s characteristics and challenges in the process of treatment. These seven factors explained 48.796% of the total variance.

A review of the literature showed that no specific scale was developed for donor conception decision-making for infertile couples. Decision-making scales such as Flinders’ decision-making questionnaire and the Melbourne decision-making questionnaire with different numbers of constructs, mostly address general issues.

Flinders’ decision-making questionnaire was developed in 1982 by Mann, for the measurement of coping patterns and strategies for decision-making in conflict resolution and consists of 31 items and three constructs, namely vigilance, hyper vigilance and defensive avoidance (including procrastination, buck-passing and rationalization). Mann et al. (34) examined the construct validity (confirmatory) of Flinders’ decision-making questionnaire in different cultural contexts (i.e. in the United States, Australia, Japan, Hong Kong, Taiwan and New Zealand). They eliminated the rationalization factor because it was not a good fit for the model and developed a new questionnaire called the Melbourne decision-making questionnaire, consisting of 22 items and four constructs, including vigilance, hyper vigilance and procrastination and buck-passing, and it replaced Flinders’ decision-making questionnaire. Although the “rationalization” construct was eliminated from Flinders’ decision-making questionnaire through the confirmatory factor analysis, coping strategies (including the use of rationalization and relaxation strategies) comprise an important factor of the DMDCQ, perhaps owing to the special nature of donor conception decision-making for infertile couples or because of the differences in the cultural contexts examined. A number of items from the Melbourne decision-making questionnaire was incorporated into the various items of the DMDCQ, such as the item “I may have to accept donor conception in order to free myself of other people’s babble”, which is similar to the item “I do not decide unless I really have to” in the Melbourne decision-making questionnaire.

Decision-making instruments about health issues include the decisional conflict scale (DCS), which measures decisional conflict in patients and contains 16 items and three subscales, including uncertainty in making a health-related decision, modifiable factors contributing to uncertainty and perceived effective decision making (35). This scale was translated into Dutch, French and Spanish and psychometrically assessed (36). Some of the items in the DCS have been incorporated into the various items of the DMDCQ, such as the item “The support of others (including my spouse and family) accelerates my decision to use donor conception”, which is similar to the item “I have enough support from others to make a choice” in the DCS. A difference between the two scales is that one of the subscales in the DCS is about perceived effective decision-making, which indicates the user’s degree of agreement about the informed decision, its compatibility with her personal values and her satisfaction with her decision. The scale developed in the present study, however, lacks a similar factor.

The decision-making scale for women with unplanned pregnancy is another decision-making scale in gynecology, which was developed by Nourizadeh et al. (37). This questionnaire consists of two scales that measure two important concepts of decision-making in women with unplanned pregnancy. The first scale measures the concept of perceived threats and is composed of 33 items within six factors, including fear of anomalies and violation of the norms, fear of difficulty and the aggravation of instability, fear of parental responsibility and commitments, fear of abortion and escape from abortion, role conflicts and social deprivations, and fear of negative physical-emotional consequences. The second scale measures decision-making style and strategies in women with unplanned pregnancy and consists of 27 items within four factors, including resistance against acceptance, avoidance-justification strategies, analytical strategies and confirmatory strategies (37). Coping strategies (the use of rationalization and relaxation) comprise an important factor of the DMDCQ that is similar to the decision-making scale for women with unplanned pregnancy, in which justification strategies (rationalizing to oneself and others) also comprise an important factor. Some of the items in the decision-making scale for women with unplanned pregnancy have been incorporated into the various items of the DMDCQ, such as the item “If I use donor conception, I won’t inform others of my decision, because I fear their negative reaction (blaming, humiliation and ridicule) toward myself and my child”, which is similar to the item “I have hidden my pregnancy from others because I am inclined toward abortion and fear others’ objection or obstruction of abortion” in the decision-making scale for women with unplanned pregnancy. The review of items showed that both scales emphasize the role of social norms in decision-making in a way that the violation of norms is a barrier to decision-making. Consequently, people who decide to use donor conception may try to conceal it in order to avoid others’ blames. A difference observed between these two scales is that confirmatory strategies comprised one of the factors in the decision-making scale for women with unplanned pregnancy, which is concerned with others’ approval and indicates counseling for the purpose of making a rational and acceptable decision. The instrument developed in the present study, however, does not include such constructs.

The general strengths of the questionnaire developed in this study include its specificity and its ease of completion. The average time taken to complete the questionnaire was 10-15 minutes depending on the respondent’s literacy.

One of the limitations of this study was the limited number of samples applying for donor conception in the only governmental infertility center in Mashhad. Other limitations included sampling from the men, as some of their wives opposed to be interviewed. Also, due to the uniqueness of the study tool, it was not possible to compare the results with other countries or check the tool’s empirical validity. Respondent bias was another limitation of this study.

The DMDCQ can contribute to the development of an instructional decision-making package and supportive interventions for improving processes of decision-making and reducing negative physical and psychological outcomes and regrets by informing caregivers and counsellors about the circumstances and procedures of decision- making by couples.