{"paper_id":"2adf595e-23b4-47e9-82cc-40f044c6b8fb","body_text":"Advances in assisted reproductive technology (ART)\noffer new methods of getting pregnant and make parenthood\npossible for people deprived of having children\nfor various reasons ( 1 ). Although these technologies\nare a ‘marriage saver’ for those left without a child\n( 2 ), give hope to millions of infertile couples ( 3 ,  4 ) and\nhelp them to realize their dream of raising a family ( 5 ),\nnot all infertile couples use reproductive technologies\n( 6 ) and the demand for these treatments is unexpectedly\nlow ( 7 ). In fact, only half of infertile couples around\nthe world seek treatments ( 7 ,  8 ). Deciding whether or\nnot to use these technologies is definitely difficult ( 9 ),\nand many sociocultural, ethical, legal and religious\nchallenges surrounding different aspects of ART, such\nas donor conception, can affect the practical use of\nthese technologies ( 3 ,  4 ).\nDeciding to use these technologies is influenced by\npeople’s perceptions and the society’s expectations and\nattitudes toward their use ( 6 ). In other words, sociocultural\nbeliefs affect couples’ tendency toward using\nthese methods ( 10 ,  11 ) and influence the rate of employment\nof these technologies by couples ( 12 ). Infertile\ncouples who have a child born through donor\nconception, experience great prejudice not only by the\nsociety but also by their family, relatives and friends. In\ndeveloping countries, the family’s rejection and social\npressures are among the factors affecting the decision\nabout seeking a method of treatment and the choice of\ntreatment is made under the heavy influence of family\nmembers ( 13 ). Many infertile couples suffer from the \nstigma of infertility and seeking treatment, and try to \nkeep their condition a secret ( 14 ). They feel that they \nwill be ethically judged for their infertility and their \ndecision to use ART ( 15 ). The individual’s beliefs and \nattitudes may be the most important determinant of his/\nher actions. Individuals with strong spiritual beliefs \nand specific sociocultural beliefs may adopt approaches \nand treatment methods that are different from those \nadopted by other infertile individuals, and their use of \ndonor conception is also influenced by different factors, \nas they attribute different meanings to their condition \nand its treatment and interpret them differently \n( 16 ). Some infertile couples for whom donor conception \nis the only way of becoming parents, they might \nprepare themselves for a childless life or accept to \nadopt a child and reject medical treatments. Some others, \nin contrast, try all the available treatments in different \nmedical centers and greatly invest for this goal \nboth in material and emotional terms ( 17 ). Sociocultural \nbeliefs may also affect people’s religious beliefs \n( 18 ). In other words, cultural factors can reinforce or \ninhibit religious attitudes toward the use of ART. Religion \nalso plays a major role in the use of ART, as it \naffects people’s views and social norms. It is difficult \nto have access to ART in countries with religious dogmatism \n( 2 ). The decision on the employment of ART is \nmade according to the laws of the society ( 19 ). Laws \nhave a significant effect on the access to ART ( 2 ). In \nsome countries, donation is a process, while in others, \nthere are limited rules. In New Zealand, embryo donation \nis a key process that is based on rules and policies \n( 20 ), while in Australia, there are few rules about the \ndonation process ( 21 ). Laws are largely based on the \nsociocultural state of the society and its ethical, spiritual \nand religious values ( 19 ,  22 ). The limited number \nof donors is also one of the main practical factors affecting \nmost couples’ decision about the selection of a \ndonor ( 23 ). Economic issues also affect the access to \nART ( 24 ).\nDeciding about the use of donor conception services \nis therefore a complicated and difficult process for couples \nwhich challenges their values and beliefs. Making \nthis decision is a complicated social and interactive \nprocess that is under the influence of various individual, \nsocial, economic, cultural, psychological and ethical \nfactors and is affected by the couple’s interactions \nwith each other and with their family, friends, health \nworkers, key people, etc. It is therefore necessary to \ndevelop a scale for identifying the determinants of infertile \ncouples’ decision about using donor conception \nto perform supportive interventions that improve the \ndecision-making process and reduce the outcomes of \nthe decision including regret. A review of the literature \ndid not show any instruments developed for direct \nmeasurement of the subject in question. Given the complexity \nof the decision-making process about this issue \nand the absence of an instrument for its assessment, the \npresent study was conducted to fill the gap, develop \na decision-making for donor conception questionnaire \n(DMDCQ) and determine its psychometric properties \nin Iranian infertile couples.\nThe scale developed in this study measures the determinants \nof infertile couples’ decision-making and \ncan help specialists to understand the issues around \ninfertile couples’ decision making concerning the use \nof ART and design individual and public training programs \nand instructional decision-making packages for \nresolving the barriers and thus reducing the need for \nunnecessary interventions.\n\nThis cross-sectional validation study was performed \nusing the method developed by DeVellis in 2012 ( 25 ) in \nfour steps, after combining some of the stages:\nIn the first step, the concept under measurement (i.e. \ndecision-making for donor conception) was theoretically \ndefined. For the first step and in order to explain participants’ \nexperiences regarding the process of decision-\nmaking for donor conception, a qualitative study with \na grounded theory approach was performed in 2014 in \nMashhad, Iran, using individual interviews. A total of \n38 participants including nine eligible infertile couples \n(four couples who were candidates for receiving egg donation, \nthree couples candidates for receiving embryo \ndonation, one couple candidate for receiving egg and \nuterus donation and one couple candidate for receiving \nuterus donation) and 14 eligible women (seven egg \ndonor candidates, four embryo donor candidates, one \negg and uterus donor candidate and two uterus donor \ncandidates), were enrolled. The key people involved in \ndecision-making for donor conception, including two \ngynecologists, two midwives and two clergymen, were \nalso interviewed during the theoretical sampling, and \nthis process was continued until the saturation of the \ncategories without any restrictions on the number of participants \nand according to the theoretical requirements \nof the study.\nThe inclusion criteria were being married, Iranian, and \ninfertile (either male or female infertility or both), having \nno biological or adopted children, nor other spouses, having \nthe experience of using at least one ART in the past or \nbeing under treatment with ART or in the waiting list to \nreceive ART, being willing to participate in the study and \nbeing able to communicate and express their experiences. \nThe selected members of the infertility treatment team \nhad at least one year of experience of working with infertile \ncouples. The selected clergymen were experts in this \nfield and were interested in participating in the study. The \nstudy was performed at Milad Infertility Clinic, Mashhad, \nIran. The participants were selected through purposive \nconvenience sampling with maximum variation in terms \nof age, duration of infertility, duration of treatment, education \nand socioeconomic status. Sampling was continued \nuntil the saturation of the data. Data collection was \nmainly done through semi-structured in-depth interviews \ndirected by the interview guide, that enabled the participants \nto freely discuss the matter. All interviews were \ndone by one of the researchers. The interviews were conducted \nseparately with the infertile men and women, but a \ncouple interview was also held with both the husband and \nwife if there was an obvious difference in their answers. \nEach interview took 40-120 minutes and was held in one \nor more sessions. The interviews were recorded with participants’ \npermission. Data were analyzed concurrently \nusing MAXQDA-2007 and five dimensions ultimately \nemerged. The approval of the local Research Ethics Committee \nof Shahid Beheshti University of Medical Sciences \nwas obtained along with the informed consent of all participants \nbefore beginning the study.\nIn the second step, an item pool was produced using an \ninductive method; for this purpose, items relevant to the \nmain concepts of donor conception decision-making were \ndeveloped based on the qualitative findings of the study \n(n=170). Participants’ attitude toward each item was \nmeasured on a 5-point Likert scale from “quite agree” to \n“quite disagree”.\nIn the third step, the initial items extracted from the \nqualitative study were reviewed by the research team and \nthe repetitive and ambiguous items were removed. Eventually, \n113 items were developed in five dimensions, including \nbeing offered to use donor conception (10 items), \ninner turmoil (4 items), attempts for coping with the current \nconditions (23 items), deciding to accept and use donor \nconception (54 items) and deciding to undergo treatment \n(22 items).\nThe face validity of the questionnaire was evaluated \nboth qualitatively and quantitatively in the fourth step. \nTo perform the qualitative evaluation, face-to-face interviews \nwere conducted with ten similar members of the \ntarget group (four infertile men and six infertile women \nwho met the inclusion criteria) and difficulties in understanding \nthe words and phrases, the degree of inappropriateness \nof the phrases or their irrelevance to the questionnaire \ndimensions, ambiguities causing misunderstanding \nof the phrases, or the words failing to convey a meaning, \nwere examined. Once the items were modified according \nto the received feedback, the item impact was measured \nquantitatively. The objective in this step was to determine \nthe item impact score in a sample that was similar to the \ntarget group. For this purpose, each item was scored on \na 5-point Likert scale as follows: 5: “quite important”, \n4: “somewhat important”, 3: “relatively important”, 2: \n“slightly important”, and 1: “not important at all”. Ten \nindividuals similar to the target group (four infertile men \nand six infertile women who met the inclusion criteria) \nwere asked to determine the importance of each item \nbased on their own experiences. The researcher calculated \nthe impact score (IS) for each item separately based on the \nfollowing equation ( 26 ):\nImpact score=Frequency percentage×level of significance\nFrequency percentage=The percentage of all the people \nwho have reviewed each item\nThe items with an IS <1.5 were considered inappropriate \nand removed from the questionnaire ( 26 ).\nThe content validity of the questionnaire was evaluated \nboth qualitatively and quantitatively. For the qualitative \nassessment of the content validity, the questionnaire was \ndistributed among ten specialists (Ph.Ds in reproductive \nhealth or health education, and a number of gynecologists) \nand they were asked to give their feedback on the \nquestionnaire. The content validity ratio (CVR) and content \nvalidity index (CVI) were used for the quantitative \nassessment of the content validity.\nTo determine the CVR, ten specialists were asked to review \neach item on a 3-point scale (3: necessary, 2: useful \nbut not necessary, and 1: not necessary). The CVR was \nthen calculated based on Lawshe’s formula as follows \n( 27 - 29 ).\nCVR=(ne–N/2)/(N/2)\nne: The number of specialists who have selected the \n“necessary” response\nBased on Lawshe’s Table of minimum values, items \nwith a CVR >0.62 as per the evaluation of the ten specialists, \nwere deemed significant (P<0.05) and remained in \nthe questionnaire ( 27 - 29 ).\nThe CVI for each item was examined based on the Waltz \nand Bausell CVI and the three criteria of simplicity, specificity \n(relevance) and clarity were separately measured on \na 4-point Likert scale by the ten specialists. To calculate \nthe CVI for each item, the total number of specialists who \nhad given 3 and 4 points (i.e. the highest score) to that item \nwas divided by the total number of specialists (n=10). The \nitems with a CVI >0.79 were deemed acceptable ( 27 - 29 ). \nThe items with a CVI of 0.7-0.79 were reviewed by the \nresearcher and discussed again with the specialists. The \nitems with a CVI <0.7 were eliminated from the questionnaire \n( 30 ).\nAfter determining the face and content validity, the \ninitial reliability was calculated as the item analysis index. \nFor this purpose, 30 infertile men and women visiting \nthe infertility clinic were selected by convenience\nsampling to complete the initial questionnaire, and the \nCronbach’s alpha was calculated to determine the internal \nconsistency for each factor as well as the entire scale. \nCronbach’s alpha values of 0.7 were considered favorable \nin this study.\nThe construct validity was determined by exploratory \nfactor analysis. For analysis of the data, the exploratory \nfactor analysis was performed in seven steps: determining \nthe sample size, examining the correlation between \nthe items, deciding about the items being fit for the factor \nanalysis, determining the number of initial factors \nextracted, rotating and extracting the final factors and \nnaming the factors.\nAccording to Tabachnick and Fidell ( 31 ), evaluation \nof the construct validity requires a sample size that is \nthree to five times larger than the number of items in the \nscale. Given the number of items in the final questionnaire \n(i.e. 69) and the potential sample loss, 220 subjects \nwere included in this study. The inclusion criteria consisted \nof being married, Iranian, infertile (with male and/\nor female infertility) and candidate for ART [intrauterine \ninsemination (IUI), in vitro fertilization (IVF), gamete \nintrafallopian transfer (GIFT), and intracytoplasmic \nsperm injection (ICSI)], and having enough information \nabout donor conception.\nThe correlation between each item and the other items \nwas examined by principal component analysis (PCA), \nand the items that had correlation with the other items of \n<0.3, were eliminated from the analysis.\nThe Kaiser-Meyer-Olkin (KMO) measure of sampling \nadequacy was used to ensure the adequacy of the \nsamples. If the KMO measure is >0.70, the set of data \nis deemed fit for factor analysis. Bartlett’s test of sphericity \nwas also used to examine the fit of the data for \nthe factor analysis. If the P value is <0.05 in this test, \nfactor analysis is considered an appropriate technique \n( 32 ). The community statistic was used to detect inappropriate \nitems whose variance was not used for explaining \nthe variance of the main factor. In this study, \nthe inflection point of 0.4 was taken as the minimum \nfactor loading required for keeping each item in the \nfactors extracted through the factor analysis. To extract \nthe required number of factors, a scree plot ( Fig .1 ) and \neigenvalues were used and the percentage of variance \nof each factor was calculated. The factors with eigenvalues \n>2 remained in the study. The final factors were \nextracted by varimax rotation.\nThe reliability of the questionnaire was examined \nusing the internal consistency and test-retest stability \nmethods. To measure the internal consistency, 30 infertile \nmen and women visiting Milad Infertility Clinic \nwere selected by convenience sampling to complete \nthe questionnaire, and Cronbach’s alpha values were \ncalculated for each factor and the entire questionnaire. \nCronbach’s alpha values of =0.7 were deemed acceptable. \nTo determine the stability of the questionnaire, \n20 infertile men and women completed the questionnaire \nwithin a two-week interval and the intraclass correlation \ncoefficient (ICC) was then calculated. An ICC \n>0.70 was deemed acceptable ( 33 ).\nScree plot.\n\nA total of 220 infertile men and women who met the inclusion \ncriteria participated in this psychometric assessment. \nTable 1 presents the demographic and infertility \ncharacteristics of the participants.\nThe demographic and infertility-related characteristics of the participants\nSD; Standard deviation.\nBased on the results of the qualitative content analysis, \nan item pool was composed of 170 items, and the ambiguous \nand repetitive items were removed after the revision \ndone by the research team. Eventually, 113 items \nwere developed in five dimensions or constructs, including \nbeing offered to use donor conception (ten items), \ninner turmoil (four items), attempts for coping with the \ncurrent conditions (23 items), deciding to accept and use \ndonor conception (54 items) and deciding to undergo \ntreatment (22 items), which entered the psychometric \nassessment phase. The evaluation of face validity, which \nwas performed qualitatively and quantitatively, led to \nthe removal of eight items, and the questionnaire entered \nthe content validity evaluation stage with 105 items. The \ncontent validity was also evaluated both qualitatively \nand quantitatively and 28 items were removed, leading \nto the existence of 77 items. In the stage of initial reliability \nevaluation, the Cronbach’s alpha was calculated \nseparately for each item, eight items were removed, and \nthe remaining 69 items entered the construct validity \nevaluation stage. It should be noted that the questionnaire’s \nreliability increased to over 0.7 once these items \nwere removed, and according to the researcher, their removal \ndid not destroy the basic information required. \nThe initial Cronbach’s alpha calculated for the entire \nscale was 0.82.\nTo determine the construct validity of the scale, \n220 participants were selected through convenience \nsampling to complete the questionnaire. There was no \nsample dropout. The collected data were entered into \nSPSS-22. The PCA showed that the correlation between \ntwo of the items and the other items was <0.3; \nthus, both of these items were removed and the factor \nanalysis was continued with 67 items. The KMO \nmeasure for the items was 0.768, which indicates the \nsampling adequacy. The Bartlett's test of sphericity \nshowed the fit of the data for the factor analysis with \nP<0.001. The community statistic was >0.4 for most \nof the items in this study and the items were thus considered \nfit for factor analysis. Five items with a community \nstatistic <0.4 were excluded from the study, \nand the factor analysis was continued with 62 items. \nDetermining the number of factors constructing the \nquestionnaire using the factor analysis of the items \nled to the identification of seven factors with eigenvalues \n>2 and explaining 48.796% of the total variance. \nThe items were rotated and categorized in each \nfactor using a varimax rotation. Of the 62 items that \nentered the factor analysis in this study, 51 items and \nseven factors remained.\nThe factors were named based on the meaning of \ntheir items, especially the meaning of the item with \nthe maximum factor loading, and with regard to the \ncorrelation found between the items and the available \ntheoretical knowledge. The researcher referred to the \nqualitative part of the study and the categories and subcategories \nforming each item, in order to name the factors \n( Table 2 ).\nThe factor loading of the Desision-Making for Donor Conception Questionnaire items in Iranian infertile couples\nTable 3 summarizes the number of items in each subscale \nand the range of scores for the entire DMDCQ and \nits subscales.\nThe range of scores for the total and subscales of the DMDCQ\nTable 4 summarizes the mean and standard deviation of \nthe total and subscale scores of the DMDCQ in the entire \nsample of participants. When the total score of the questionnaire \nand the scores of its subscales are higher, higher \nnumbers of individuals make positive decisions and the \ncouple will be more inclined toward donor conception in \nthe future.\nThe mean and standard deviation (SD) of the total and subscale scores of the decision-making donor conception questionnaire (DMDCQ) in the entire sample (n=220)\nMin; Minimum and Max; Maximum.\nThe initial Cronbach’s alpha was 0.82 for the entire scale \nand 0.75-0.87 for each subscale. The ICC was >0.7 for \nall the factors, which confirms the high reliability of the \nquestionnaire ( Table 5 ).\nThe Cronbach’s alpha and intraclass correlation coefficient (ICC) of subscales and the entire questionnaire\n\nThe questionnaire developed in this study is the first \nand only valid and reliable scale developed and psychometrically \nassessed in the world, concerning donor conception \ndecision-making. The questionnaire consists of \n51 items within seven factors, including the role of social \nnetworks, coping strategies, the decision to disclose \nor conceal, interpersonal relationships, religious quests, \ndonor’s characteristics and challenges in the process of \ntreatment. These seven factors explained 48.796% of the \ntotal variance.\nA review of the literature showed that no specific scale \nwas developed for donor conception decision-making for \ninfertile couples. Decision-making scales such as Flinders’ \ndecision-making questionnaire and the Melbourne \ndecision-making questionnaire with different numbers of \nconstructs, mostly address general issues.\nFlinders’ decision-making questionnaire was developed \nin 1982 by Mann, for the measurement of coping patterns \nand strategies for decision-making in conflict resolution \nand consists of 31 items and three constructs, namely vigilance, \nhyper vigilance and defensive avoidance (including \nprocrastination, buck-passing and rationalization). Mann \net al. ( 34 ) examined the construct validity (confirmatory) \nof Flinders’ decision-making questionnaire in different \ncultural contexts (i.e. in the United States, Australia, Japan, \nHong Kong, Taiwan and New Zealand). They eliminated \nthe rationalization factor because it was not a good \nfit for the model and developed a new questionnaire called \nthe Melbourne decision-making questionnaire, consisting \nof 22 items and four constructs, including vigilance, \nhyper vigilance and procrastination and buck-passing, \nand it replaced Flinders’ decision-making questionnaire. \nAlthough the “rationalization” construct was eliminated \nfrom Flinders’ decision-making questionnaire through the \nconfirmatory factor analysis, coping strategies (including \nthe use of rationalization and relaxation strategies) comprise \nan important factor of the DMDCQ, perhaps owing \nto the special nature of donor conception decision-making \nfor infertile couples or because of the differences in the \ncultural contexts examined. A number of items from the \nMelbourne decision-making questionnaire was incorporated \ninto the various items of the DMDCQ, such as the \nitem “I may have to accept donor conception in order to \nfree myself of other people’s babble”, which is similar to \nthe item “I do not decide unless I really have to” in the \nMelbourne decision-making questionnaire.\nDecision-making instruments about health issues include \nthe decisional conflict scale (DCS), which measures \ndecisional conflict in patients and contains 16 items \nand three subscales, including uncertainty in making a \nhealth-related decision, modifiable factors contributing to \nuncertainty and perceived effective decision making ( 35 ). \nThis scale was translated into Dutch, French and Spanish \nand psychometrically assessed ( 36 ). Some of the items in \nthe DCS have been incorporated into the various items \nof the DMDCQ, such as the item “The support of others \n(including my spouse and family) accelerates my decision \nto use donor conception”, which is similar to the item \n“I have enough support from others to make a choice” \nin the DCS. A difference between the two scales is that \none of the subscales in the DCS is about perceived effective \ndecision-making, which indicates the user’s degree of \nagreement about the informed decision, its compatibility \nwith her personal values and her satisfaction with her decision. \nThe scale developed in the present study, however, \nlacks a similar factor.\nThe decision-making scale for women with unplanned \npregnancy is another decision-making scale in gynecology, \nwhich was developed by Nourizadeh et al. ( 37 ). This \nquestionnaire consists of two scales that measure two important \nconcepts of decision-making in women with unplanned \npregnancy. The first scale measures the concept of \nperceived threats and is composed of 33 items within six \nfactors, including fear of anomalies and violation of the \nnorms, fear of difficulty and the aggravation of instability, \nfear of parental responsibility and commitments, fear of \nabortion and escape from abortion, role conflicts and social \ndeprivations, and fear of negative physical-emotional \nconsequences. The second scale measures decision-making \nstyle and strategies in women with unplanned pregnancy \nand consists of 27 items within four factors, including \nresistance against acceptance, avoidance-justification \nstrategies, analytical strategies and confirmatory strategies \n( 37 ). Coping strategies (the use of rationalization and \nrelaxation) comprise an important factor of the DMDCQ \nthat is similar to the decision-making scale for women \nwith unplanned pregnancy, in which justification strategies \n(rationalizing to oneself and others) also comprise an \nimportant factor. Some of the items in the decision-making \nscale for women with unplanned pregnancy have been \nincorporated into the various items of the DMDCQ, such \nas the item “If I use donor conception, I won’t inform others \nof my decision, because I fear their negative reaction \n(blaming, humiliation and ridicule) toward myself and my \nchild”, which is similar to the item “I have hidden my \npregnancy from others because I am inclined toward abortion \nand fear others’ objection or obstruction of abortion” \nin the decision-making scale for women with unplanned \npregnancy. The review of items showed that both scales \nemphasize the role of social norms in decision-making in \na way that the violation of norms is a barrier to decision-making. Consequently, people who decide to use donor \nconception may try to conceal it in order to avoid others’ \nblames. A difference observed between these two scales is \nthat confirmatory strategies comprised one of the factors \nin the decision-making scale for women with unplanned \npregnancy, which is concerned with others’ approval and \nindicates counseling for the purpose of making a rational \nand acceptable decision. The instrument developed in the \npresent study, however, does not include such constructs.\nThe general strengths of the questionnaire developed in \nthis study include its specificity and its ease of completion. \nThe average time taken to complete the questionnaire \nwas 10-15 minutes depending on the respondent’s \nliteracy.\nOne of the limitations of this study was the limited number \nof samples applying for donor conception in the only \ngovernmental infertility center in Mashhad. Other limitations \nincluded sampling from the men, as some of their \nwives opposed to be interviewed. Also, due to the uniqueness \nof the study tool, it was not possible to compare the \nresults with other countries or check the tool’s empirical \nvalidity. Respondent bias was another limitation of this \nstudy.\n\nThe DMDCQ can contribute to the development of an \ninstructional decision-making package and supportive interventions \nfor improving processes of decision-making \nand reducing negative physical and psychological outcomes \nand regrets by informing caregivers and counsellors \nabout the circumstances and procedures of decision-\nmaking by couples.","source_license":"CC-BY-4.0","license_restricted":false}