Development and Validation of A Decision-Making Donor
Conception Questionnaire in Iranian Infertile Couples
Despite the fact that many infertile couples have to decide about whether or not to choose donor con- ception, there is no predictive scale for evaluating the process of decision-making on donor conception and its deter- minants in such couples. The present study was conducted to develop a decision-making questionnaire for selecting donor conception and assess its psychometric properties in Iranian infertile couples.
Materials and Methods
This cross-sectional validation study was conducted based on the method developed by DeVellis (2012) in four steps at Milad Infertility Clinic, Mashhad, Iran. The dimensions of the concept of decision- making were determined in the first step based on the qualitative results obtained from 38 semi-structured in-depth interviews. Items that were appropriate for the questionnaire were developed in the second step using the qualitative data and a review of the literature. In the third step, the research team reviewed and eliminated some of the items. The fourth step evaluated the face, content and construct validity of the questionnaire through exploratory factor analysis on a sample of 220 infertile couples using convenience sampling and investigated its initial and final reliability.
Based on the results of the qualitative study, a pool of 170 items was developed, 101 of which were elimi- nated after revision due to ambiguity, repetition or their poor face and content validity and initial reliability. The questionnaire was evaluated for its construct validity with 69 items. After the exploratory factor analysis, the decision- making donor conception questionnaire (DMDCQ) having 51 items and seven factors, was finalized. All the factors had Cronbach’s alpha values of 0.75-0.87 and intra-class correlation coefficients (ICC) greater than 0.7.
This study led to development of a valid and reliable scale for examining infertile couples’ decision- making about whether or not to use donor conception as well as the determinants of this decision.
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.
Materials and Methods
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:
First step: Performing a qualitative study and extracting the dimensions or constructs of the intended concept
In the first step, the concept under measurement (i.e. decision-making for donor conception) was theoretically defined. For the first step and in order to explain participants’ experiences regarding the process of decision- making for donor conception, a qualitative study with a grounded theory approach was performed in 2014 in Mashhad, Iran, using individual interviews. A total of 38 participants including nine eligible infertile couples (four couples who were candidates for receiving egg donation, three couples candidates for receiving embryo donation, one couple candidate for receiving egg and uterus donation and one couple candidate for receiving uterus donation) and 14 eligible women (seven egg donor candidates, four embryo donor candidates, one egg and uterus donor candidate and two uterus donor candidates), were enrolled. The key people involved in decision-making for donor conception, including two gynecologists, two midwives and two clergymen, were also interviewed during the theoretical sampling, and this process was continued until the saturation of the categories without any restrictions on the number of participants and according to the theoretical requirements of the study.
The inclusion criteria were being married, Iranian, and infertile (either male or female infertility or both), having no biological or adopted children, nor other spouses, having the experience of using at least one ART in the past or being under treatment with ART or in the waiting list to receive ART, being willing to participate in the study and being able to communicate and express their experiences. The selected members of the infertility treatment team had at least one year of experience of working with infertile couples. The selected clergymen were experts in this field and were interested in participating in the study. The study was performed at Milad Infertility Clinic, Mashhad, Iran. The participants were selected through purposive convenience sampling with maximum variation in terms of age, duration of infertility, duration of treatment, education and socioeconomic status. Sampling was continued until the saturation of the data. Data collection was mainly done through semi-structured in-depth interviews directed by the interview guide, that enabled the participants to freely discuss the matter. All interviews were done by one of the researchers. The interviews were conducted separately with the infertile men and women, but a couple interview was also held with both the husband and wife if there was an obvious difference in their answers. Each interview took 40-120 minutes and was held in one or more sessions. The interviews were recorded with participants’ permission. Data were analyzed concurrently using MAXQDA-2007 and five dimensions ultimately emerged. The approval of the local Research Ethics Committee of Shahid Beheshti University of Medical Sciences was obtained along with the informed consent of all participants before beginning the study.
Second step: Producing an item pool using an inductive method
In the second step, an item pool was produced using an inductive method; for this purpose, items relevant to the main concepts of donor conception decision-making were developed based on the qualitative findings of the study (n=170). Participants’ attitude toward each item was measured on a 5-point Likert scale from “quite agree” to “quite disagree”.
Third step: Initial items reduction
In the third step, the initial items extracted from the qualitative study were reviewed by the research team and the repetitive and ambiguous items were removed. Eventually, 113 items were developed in five dimensions, including being offered to use donor conception (10 items), inner turmoil (4 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).
Fourth step: Validation of the questionnaire through assessing its face validity, content validity, initial reliability, construct validity and final reliability
The face validity of the questionnaire was evaluated both qualitatively and quantitatively in the fourth step. To perform the qualitative evaluation, face-to-face interviews were conducted with ten similar members of the target group (four infertile men and six infertile women who met the inclusion criteria) and difficulties in understanding the words and phrases, the degree of inappropriateness of the phrases or their irrelevance to the questionnaire dimensions, ambiguities causing misunderstanding of the phrases, or the words failing to convey a meaning, were examined. Once the items were modified according to the received feedback, the item impact was measured quantitatively. The objective in this step was to determine the item impact score in a sample that was similar to the target group. For this purpose, each item was scored on a 5-point Likert scale as follows: 5: “quite important”, 4: “somewhat important”, 3: “relatively important”, 2: “slightly important”, and 1: “not important at all”. Ten individuals similar to the target group (four infertile men and six infertile women who met the inclusion criteria) were asked to determine the importance of each item based on their own experiences. The researcher calculated the impact score (IS) for each item separately based on the following equation (26):
Impact score=Frequency percentage×level of significance
Frequency percentage=The percentage of all the people who have reviewed each item
The items with an IS <1.5 were considered inappropriate and removed from the questionnaire (26).
The content validity of the questionnaire was evaluated both qualitatively and quantitatively. For the qualitative assessment of the content validity, the questionnaire was distributed among ten specialists (Ph.Ds in reproductive health or health education, and a number of gynecologists) and they were asked to give their feedback on the questionnaire. The content validity ratio (CVR) and content validity index (CVI) were used for the quantitative assessment of the content validity.
To determine the CVR, ten specialists were asked to review each item on a 3-point scale (3: necessary, 2: useful but not necessary, and 1: not necessary). The CVR was then calculated based on Lawshe’s formula as follows (27-29).
ne: The number of specialists who have selected the “necessary” response
The CVI for each item was examined based on the Waltz and Bausell CVI and the three criteria of simplicity, specificity (relevance) and clarity were separately measured on a 4-point Likert scale by the ten specialists. To calculate the CVI for each item, the total number of specialists who had given 3 and 4 points (i.e. the highest score) to that item was divided by the total number of specialists (n=10). The items with a CVI >0.79 were deemed acceptable (27-29). The items with a CVI of 0.7-0.79 were reviewed by the researcher and discussed again with the specialists. The items with a CVI <0.7 were eliminated from the questionnaire (30).
After determining the face and content validity, the initial reliability was calculated as the item analysis index. For this purpose, 30 infertile men and women visiting the infertility clinic were selected by convenience sampling to complete the initial questionnaire, and the Cronbach’s alpha was calculated to determine the internal consistency for each factor as well as the entire scale. Cronbach’s alpha values of 0.7 were considered favorable in this study.
The construct validity was determined by exploratory factor analysis. For analysis of the data, the exploratory factor analysis was performed in seven steps: determining the sample size, examining the correlation between the items, deciding about the items being fit for the factor analysis, determining the number of initial factors extracted, rotating and extracting the final factors and naming the factors.
According to Tabachnick and Fidell (31), evaluation of the construct validity requires a sample size that is three to five times larger than the number of items in the scale. Given the number of items in the final questionnaire (i.e. 69) and the potential sample loss, 220 subjects were included in this study. The inclusion criteria consisted of being married, Iranian, infertile (with male and/ or female infertility) and candidate for ART [intrauterine insemination (IUI), in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), and intracytoplasmic sperm injection (ICSI)], and having enough information about donor conception.
The correlation between each item and the other items was examined by principal component analysis (PCA), and the items that had correlation with the other items of <0.3, were eliminated from the analysis.
The Kaiser-Meyer-Olkin (KMO) measure of sampling adequacy was used to ensure the adequacy of the samples. If the KMO measure is >0.70, the set of data is deemed fit for factor analysis. Bartlett’s test of sphericity was also used to examine the fit of the data for the factor analysis. If the P value is <0.05