Literature DB >> 21458806

The Fertility Quality of Life (FertiQoL) tool: development and general psychometric properties.

Jacky Boivin1, Janet Takefman, Andrea Braverman.   

Abstract

OBJECTIVE: To develop the first international instrument to measure fertility quality of life, FertiQoL, in men and women experiencing fertility problems, to evaluate the preliminary psychometric properties of this new tool and to translate FertiQoL into multiple languages.
DESIGN: Survey.
SETTING: Online and fertility clinics in USA, Australia/New Zealand, Canada, and United Kingdom. PARTICIPANTS: A total of 1,414 people with fertility problems. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): FertiQoL. RESULT(S): FertiQoL consists of 36 items that assess core (24 items) and treatment-related (10 items) quality of life as well as overall life and physical health (2 items). Cronbach reliability statistics for the Core and Treatment FertiQoL (and subscales) were satisfactory, in the range of 0.72 and 0.92. Sensitivity analyses showed that FertiQoL detected expected relations between quality of life and gender, parity, and support seeking. FertiQoL was translated into 20 languages by the same translation team, with each translation verified by local bilingual fertility experts. CONCLUSION(S): FertiQoL is a reliable measure of the impact of fertility problems and its treatment on quality of life. Future research should establish its use in cross-cultural research and clinical work.
Copyright © 2011. Published by Elsevier Inc.

Entities:  

Mesh:

Year:  2011        PMID: 21458806      PMCID: PMC7094343          DOI: 10.1016/j.fertnstert.2011.02.046

Source DB:  PubMed          Journal:  Fertil Steril        ISSN: 0015-0282            Impact factor:   7.490


“Quality of life” (QoL) was defined by the World Health Organization (WHO) as “individuals’ perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards, and concerns” (1). The WHOQoL measure of quality of life broadly according to 29 facets (e.g., self-esteem, mobility, safety). QoL measurement is important to identify aspects of fertility problems associated with poor QoL and advance research in health service evaluation, patient satisfaction, and policy making through the use of a standard measurement tool (2). Psychosocial studies convincingly demonstrate a high incidence of negative reactions to infertility and its treatment (3) which affect overall life satisfaction and well-being (4), success of treatment (5), willingness to continue with treatment (6), treatment evaluation (7), and the long-term satisfaction people can hope to achieve if treatment is unsuccessful and they remain childless (8). Therefore, the need to measure and take into account QoL in infertility is imperative, and tackling this measurement hurdle could lead to improved patient outcomes. The 14 existing self-report measures of infertility-specific distress, treatment reactions, and QoL presented in Supplemental Table 1 (available online at www.fertstert.org) do not fulfill the need for a fertility-specific QoL assessment tool. The Fertility Problem Inventory (FPI) is the most frequently used distress measure (9). However, the items were developed without consultation with people experiencing fertility problems, and the validation sample comprised primarily caucasian patients from a homogeneous socioeconomic category using assisted reproductive techniques (ART). Furthermore, the FPI assesses level of strain rather than the broader construct of QoL and does not separate effects due to infertility treatment from those due to childlessness, which is important given the emotional challenges of each. These issues apply to most measures listed in Supplemental Table 1. The most frequently used QoL measure was developed for women suffering from polycystic ovarian syndrome (PCOSQ) (10). Several studies have examined its psychometric properties (11) and used it to investigate moderators of QoL (e.g., obesity) and cross-cultural effects. Results confirm its reliability and the importance of cultural background as a moderator of QoL 12, 13. However, this and other fertility QoL measures were designed for specific subpopulations (e.g., endometriosis, male factor) and therefore cannot be used as generic measures for all people with fertility problems. In summary, the need for a fertility QoL measure has not been fully met. Given the importance of addressing this need, the European Society of Human Reproduction and Embryology (ESHRE) and the American Society of Reproductive Medicine (ASRM) joined forces with Merck-Serono, Geneva,Switzerland (an affiliate of Merck, Darmstadt, Germany) to create FertiQoL (2002–2009). The overall aim of the FertiQoL project was to develop an international instrument to measure quality of life in men and women experiencing fertility problems. Secondary aims were to evaluate the psychometric properties of the tool and to translate FertiQoL in multiple languages. The development phase was carried out according to the protocol used for the development of the WHO QoL measure (14) and is briefly described in the present article. However, the main focus of this report is on the psychometric evaluation.

Methods

Participants

Men and women experiencing fertility difficulties with and without medical experience were sampled from one fertility clinic each in Australia, Canada, New Zealand, and the United Kingdom and two clinics in the United States. Patient advocacy websites in these countries (i.e., Access, American Fertility Association, Resolve, Infertility Awareness Association of Canada, International Consumer Support for Infertility, Infertility Network UK) hosted the online survey. The clinical sample consisted of 291 women and 75 men, and the online sample consisted of 1,014 women and 34 men. The Ethics Committee of the School of Psychology, Cardiff University, approved the online study, and the Internal Review Board of each clinic approved the clinical studies.

Materials

The Background Information Form covered sociodemographic status (e.g., age, education), medical history (e.g., current illness), and fertility-related characteristics (e.g., duration of infertility).

FertiQoL prototype

The FertiQol items were designed to translate abstract concepts (e.g., commitment, sense of belonging) into quantitative items that collectively could indicate the impact of fertility problems on QoL. Full details of item generation for the prototype are described in the Supplemental Methods (available on line at www.fertstert.org) and briefly presented here. As shown in Table 1 , item-generation involved four stages: generating potential items; eliminating redundant, irrelevant and outlier items; validation among people with fertility problems; and cross-cultural survey of acceptability and feasibility. A comprehensive literature review and consultation with psychosocial infertility experts generated an initial pool of 302 items on consequences of fertility problems on QoL in 14 areas (e.g., marriage/partnership, social network, emotions, cognitions, coping, treatment, physical health). The authors classified the 302 items into three levels of increasing concept specificity—dimensions (e.g., interpersonal), domains (e.g., partner relationship) and facets (e.g., intimacy)—to form groups of items tapping into related aspects of QoL. Classification and subsequent focus groups reduced this pool to 102 items, which were submitted to the acceptability and feasibility study (Table 1). The prototype evaluated in the present study included these 102 core items and 27 optional treatment items identified through the feasibility and acceptability phase.
Table 1

Steps in FertiQoL item generation, selection, and reduction carried out before this psychometric evaluation.

Task and aimParticipantsMaterialsOutcome
Literature review and expert consultation to generate potential itemsPsychosocial experts in reproductive health (n = 17)FertiQoL steering committee (n = 10)Groups included researchers, psychologists, social workers, counselors, patients, gynecologists, nurses, and clinicians in 11 countries: Australia, Canada, Denmark, France, Germany, Italy, New Zealand, Sweden, Switzerland, UK, USAPsychosocial studiesExisting fertility-related toolsTreatment evaluation toolsQoL measuresWHO development manual302 items in 14 domains (e.g., partnership, self-esteem, career)
Classification and reduction of item pool to eliminate redundant or irrelevant items or rare QoL effectsFertiQoL technical working group (Boivin, Takefman, Braverman) and expert panelWHO selection criteria: items should be revealing of QoL, cover key domains, use simple language, ask about single issues, be free of ambiguity, etc.Item pool reduced to 116 itemsWHO response scales matched to items
Focus groups with patients to validate the items generated by the experts and uncover any effects overlooked by the experts17 focus groups (n = 136 participants): Canada, Germany, Mexico, USA, ItalyaPurposive sampling for age (< or ≥35 years), gender, duration of infertility (< or ≥2 years) and parity (< or ≥1 child)Psychosocial experts facilitated open, unstructured discussion groups followed by structured feedback exercise on FertiQoL item pool; duration 1.5–2 hStructured interview guide (facilitators), workbooks (participants), and 116-item pool FertiQoLItem decrease from 116 to 102 (22 items eliminated and 8 added) based on > or <50% endorsementAdded 18 treatment items; wording corrected; eliminated and/or combined redundant items; improved face validity; ensured items pertained to QoL and response scale appropriate
Survey to assess acceptability and feasibility of FertiQoL item style in different languagesn = 525 men and women in 10 countries: Argentina (n = 48), Brazil (n = 96), Canada (n = 59), France (n = 63), Germany (n = 37), Greece (n = 32), Italy (n = 47), Mexico (n = 46), New Zealand (n = 11), Spain (n = 43), UK (n = 79) and USA (n = 43)102 Core FertiQoL + 27 optional Treatment itemsAdditional items inquired about clarity, coverage, and problems with item poolMaterial translated by expertsFinal Core FertiQol pool for psychometric phase was 102 items + 27 optional Treatment itemsFertiQoL well accepted, perceived to be important and timelyItems easy to understand and relevantFertiQoL completing in 15–20 minutesMain problems: items that did not apply to all people (e.g., single or untreated) and time frame for “instructions” required

Note: FertiQoL technical working group involved in all aspects of project development. QoL = quality of life; WHO = World Health Organization.

Focus groups in Singapore canceled owing to the severe acute respiratory syndrome virus.

Steps in FertiQoL item generation, selection, and reduction carried out before this psychometric evaluation. Note: FertiQoL technical working group involved in all aspects of project development. QoL = quality of life; WHO = World Health Organization. Focus groups in Singapore canceled owing to the severe acute respiratory syndrome virus.

Translation

FertiQoL was produced in English and translated into 20 languages: Arabic, Chinese, Croatian, Danish, Dutch, English, Finnish, French, German, Greek, Hindi, Italian, Portuguese, Romanian, Russian, Serbian, Spanish, Swedish, Turkish, and Vietnamese (available online at www.fertiqol.org). At the time of writing, Korean and Hungarian versions were in progress. Cardiff University professional translators carried out the first translation, and two local fertility experts reviewed it to ensure it was appropriate to local customs and fertility references. Cross-cultural data will be presented in a separate paper.

Procedure

The items in the prototype FertiQoL survey were randomly presented and rated on a scale of 0 to 4, where higher scores indicated more favorable QoL. The online survey (prototype FertiQoL and Background Information Form) was designed using SurveyTracker software (Training Technologies, 2008), and the paper version for clinic distribution was designed using InDesign. Webmasters were provided with a hyperlink to the survey. In clinics, FertiQoL coordinators at each site distributed the study pack to consecutive patients, who returned completed surveys anonymously in a marked collection box in the patient waiting room.

Statistical analysis

Data were screened, and duplicate internet protocol (IP) addresses were eliminated unless of different gender and response pattern. Descriptive statistics and correlations were used to identify the best items for each a priori domain of QoL (e.g., emotional, mind/body, relational, social). This a priori work was done to ensure that conceptually similar groups of items were entered into the factor analysis. Factor analyses (orthogonal rotation) were computed (clinic, online) to ascertain relations among these items. Items with factor loadings <0.30 and eigenvalues <1 were eliminated. The FertiQoL total and subscale scores were computed and transformed to scaled scores and summary statistics (e.g., reliability coefficient, mean, SD) produced. Scaled scores were computed to achieve a range of 0 to 100, making comparisons between scales easier. For scaling, items were reverse scored where necessary and all items then summed and multiplied by 25/k, where k was the number of items in the desired subscale or total scale. Higher scores mean better QoL. For the sake of brevity, only final analyses are shown here. These analyses generated the final FertiQoL, which comprised 24 core items, plus 10 optional treatment items. The final FertiQoL in all languages and with scoring instructions is available online at www.fertiqol.org.

Results

Sample Characteristics

Table 2 shows background characteristics, and these show that the clinical group were older and included more men, single women, same-sex couples, and people with a university education, but fewer American and UK residents and people living in rural/suburban areas compared with the online sample. The clinical sample was more likely to have at least one child and a shorter duration of infertility, but less likely to have other health problems.
Table 2

Demographic characteristics of the online and clinic samples.a

VariableOnline (n = 1,048)Clinic (n = 366)Test statistic (χ2 or t)
Demographics
 Age (y), mean (SD)32.9 (4.9)35.2 (4.0)7.9b
 Women, % (n)96.8 (1014)79.5 (291)113.4b
Relationship status, % (n)49.4b
 Single.2 (3)4.0 (13)
 In stable relationship
 Same-sex1.7 (18)6.2 (20)
 Heterosexual98.0 (1027)89.8 (289)
Duration of partnership (y), mean (SD)d6.85 (3.9)7.0 (3.9).6
University education, % (n)57.1 (598)66.2 (139)9.5c
Residence, % (n)40.4b
 Urban28.3 (296)27.1 (95)
 Suburban55.8 (584)69.5 (244)
 Rural15.9 (166)3.4 (12)
Country, % (n)243.4b
 Australia/NZ14.5 (152)25.1 (92)
 Canada10.3 (108)42.0 (154)
 UK8.7 (91)2.7 (10)
 USA64.1 (672)30.2 (111)
 Other2.4 (25)
Reproductive characteristics
 Parenthood, % (n)18.9 (197)30.1 (108)19.8b
 Years infertile, mean (SD)3.4 (2.9)2.9 (2.0)2.4c
 Know why infertile, % (n)75.4 (790)70.3 (225)3.3
Perceived diagnosis, % (n)82.4b
 Unexplained10.9 (86)14.0 (38)
 Female factor44.5 (351)18.0 (49)
 Male factor19.9 (157)21.7 (59)
 Mixed11.9 (94)14.7 (40)
 Same-sex1.6 (13)3.3 (9)
 Age-related4.1 (32)8.8 (24)
 Other7.1 (56)19.5 (53)
Other health problems, % (n)30.8 (309)24.0 (260)5.8c
Years treated, mean (SD)2.03 (2.4)2.43 (1.8)1.6

Note: 491 people did not provide data for years of treatment because of no treatment experience or missing data.

Sample size varies per variable.

P<.001.

P<.05.

For people in partnerships.

Demographic characteristics of the online and clinic samples.a Note: 491 people did not provide data for years of treatment because of no treatment experience or missing data. Sample size varies per variable. P<.001. P<.05. For people in partnerships.

Item Analyses

Descriptive and inferential statistics were used to screen for problematic items. Items were deleted for several reasons (i.e., highly skewed distribution, high intercorrelations (>0.80 among item set, poor scale coherence, interpretive issues). Other items were deleted because they measured broad constructs (e.g., self-esteem) that could be better captured by measures designed for that purpose and that, if retained, would confound associations with those measures in future research. The final FertiQoL item set submitted for exploratory factor analysis comprised 24 items from the core set of items and 10 items from the optional treatment module. The 24 core items were conceptualized as reflecting QoL in the emotional, mind-body (i.e., cognitive and physical), relational, and social domains. The 10 optional treatment items were conceptualized as indexing treatment environment and treatment tolerability. An additional two items measuring satisfaction with QoL and physical health were retained for the FertiQoL measure to indicate general physical and QoL satisfaction, but they were not included in the factor analysis.

Exploratory Factor Analyses and Internal Consistency

Kaiser-Meyer-Olkin measures of sampling adequacy were >0.80, demonstrating sufficient intercorrelation among items to perform factor analyses. Table 3 presents factor loadings for the online and (in parentheses) clinical samples for the Core FertiQoL and optional Treatment module. The first factor explaining item variance in the Core FertiQoL was the Emotional subscale, explaining 31.8% (online) and 37.8% (clinic) of the item variability. Other factors (Mind/Body, Relational, Social) explained ≤10% of the item variance, but all eigenvalues were >1. Loadings showed that items conceptualized to tap into the same concepts all had high factor loadings (>0.30) on their designated factor. Cross-loadings were observed for items of the Mind/Body (i.e., concentration, life on hold) and Social domains (i.e., isolation, shame) onto the Emotional domains. For the optional Treatment module, the first factor was Treatment Environment, explaining 34.0% (online) and 38.0% (clinic) of item variance. There were no cross-loadings for the Treatment Quality and Treatment Tolerability subscales. Table 4 presents summary information for all FertiQoL scales. Core FertiQoL and Treatment FertiQoL were normally distributed, and individual subscales were normally distributed (data not shown), with only the relational subscale showing mild positive skew toward more favorable QoL in this domain.
Table 3

Factor loadings for online and clinical (in parenthesis) samples on FertiQoL items.

Core FertiQoL
Optional FertiQoL Treatment module
EmotionalRelationalMind/BodySocialTreatment EnvironmentTreatment Tolerability
Angry0.752 (0.800)
Grief/loss0.763 (0.792)
Sad/depressed0.730 (0.772)
Fluctuate hope/despair0.643 (0.759)
Jealousy and resentment0.737 (0.634)
Unable to cope0.640 (0.594)
Affectionate0.749 (0.732)
Difficult to talk0.629 (0.696)
Negative impact on relationship0.707 (0.633)
Content relationship0.768 (0.616)
Strengthen relationship0.713 (0.603)
Satisfied sexual relationship0.575 (0.600)
Fatigue0.731 (0.745)
Pain/discomfort0.566 (0.663)
Feel worn outb0.620 (0.627)
Disrupt activities0.704 (0.625)
Concentration(0.634)a0.554 (0.413)
Life on holdb(0.577)a0.572 (0.355)
Family understand0.669 (0.669)
Friend support0.751 (0.649)
Society expect0.495 (0.446)
Isolated(0.558)a0.509 (0.531)
Handle/pregnant othersb0.538a (0.589)a0.306 (0.350)
Shame, embarrassmentb0.527a (0.580)a0.319 (0.440)
Interactions with staff0.813 (0.784)
Quality treatment information0.802 (0.784)
Quality surgery and medical treatment0.780 (0.763)
Fertility staff understand us0.728 (0.750)
Quality emotional services0.632 (0.664)
Medical services desired available0.576 (0.585)
Bothered effect daily activities and work0.799 (0.790)
Bothered physical effects0.792 (0.732)
Complicated medication and procedures0.645 (0.715)
Treatment effects on mood0.645 (0.681)
Online eigenvalue (% variance)7.62 (31.8)2.61 (10.9)1.44 (6.0)1.16 (4.8)3.48 (34.9)1.92 (19.3)
Clinical eigenvalue (% variance)8.93 (37.8)2.37 (9.9)1.23 (5.1)1.08 (4.5)3.80 (38.0)1.68 (16.8)

Note: Some items reversed to avoid negative loadings. Only factor loadings >0.30 are shown. Factor loadings for Clinic sample in parentheses. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org.

Cross-loadings.

Wording for these items changed as a result of psychometric evaluation and participant feedback.

Table 4

Means and standard deviations for FertiQoL subscales and total scaled scores for the validation sample (online and clinical combined).

ScalenQoL domainNo. of itemsCronbach alphaMean (SD) scaled score 0–100
Core subscales
 Emotional1,349Impact on emotions (e.g., causes sadness, resentment, grief)60.9045.10 (23.2)
 Mind-Body1,338Impact on physical health (e.g., fatigue, pain), cognition (e.g., poor concentration) and behavior (e.g., disrupted daily activities)60.8454.86 (21.2)
 Relational1,330Impact on partnership (e.g., sexuality, communication, commitment)60.8068.70 (19.2)
 Social1,343Impact on social aspects (e.g., social inclusion, expectations, support)60.7551.10 (20.6)
Core FertiQoL1,226Overall core fertility quality of life240.9254.60 (16.8)
Treatment subscales
 Environment1,072Impacts related to treatment environment (e.g., access, quality, interactions with staff)60.8461.53 (19.6)
 Treatment tolerability1,093Impacts due to consequences of treatment (e.g., physical and mode effects, daily disruptions)40.7258.81 (20.6)
Treatment FertiQoL1,043Overall treatment quality of life100.8160.43 (16.2)
Total FertiQoL930Overall fertility quality of life340.9255.43 (14.8)

Note: All items reversed or scored so that higher scores indicate more favorable quality of life. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org.

Factor loadings for online and clinical (in parenthesis) samples on FertiQoL items. Note: Some items reversed to avoid negative loadings. Only factor loadings >0.30 are shown. Factor loadings for Clinic sample in parentheses. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org. Cross-loadings. Wording for these items changed as a result of psychometric evaluation and participant feedback. Means and standard deviations for FertiQoL subscales and total scaled scores for the validation sample (online and clinical combined). Note: All items reversed or scored so that higher scores indicate more favorable quality of life. Final FertiQoL item wording, response scale wording, and downloads in 20 languages are available at www.fertiqol.org.

Sensitivity Analyses for Subscales and Total Scores

Potential moderators of QoL (gender, parenthood status, and recruitment source) were examined in relation to FertiQoL scores. Women had a significantly lower Core FertiQoL (mean 53.3, SD 16.2) than did men (mean 72.1, SD 14.7; t(1,224) = 10.3; P<.001). Core FertiQoL was significantly lower for participants without children (mean 53.3, SD 16.3) than for participants with children (mean 59.5, SD 17.7; t(1,217) = 5.27; P<.001). Participants recruited from the online patient advocacy and support sites had significantly lower scores (mean 50.7, SD 15.1) than participants recruited from clinics (mean 67.8, SD 15.6; t(1,224) = 16.6; P<.001). The relationship between Treatment subscales and six treatment persistence items (e.g., likelihood of trying further treatment, couple agreeing to persist, thinking of ending treatment) was also examined. Greater intention to persist with treatment was significantly associated with better Treatment FertiQoL (r(1,026) = 0.172; P<.001), especially in the clinical sample (r(206) = 0.289; P<.001).

Discussion

It is currently accepted that to effectively measure the impact of disease, one needs a disease-specific instrument (1). FertiQol is a reliable and sensitive measurement tool for QoL in individuals with fertility problems. More than 2,000 people with fertility problems contributed to the creation of FertiQoL, and it was developed by using an integrated mixed-methods approach that included literature reviews, international expert consultations, patient focus groups, a cross-cultural feasibility and acceptability survey, and a psychometric survey evaluation. FertiQoL comprises a Core module evaluating the impact of fertility problems on emotional, mind-body, relational, and social domains, and an optional treatment module evaluating treatment environment and tolerability. Subscales and total scales show mainly high reliability and sensitivity of FertiQoL to well established moderators of QoL. FertiQoL is available in 20 languages with more translations in progress. This project was fully realized as a result of collaboration among ESHRE, ASRM, and Merck, Geneva, Switzerland (an affiliate of Merck, Darmstadt, Germany). It is expected that FertiQoL will significantly contribute to future research and clinical endeavors aimed at investigating and ultimately improving quality of life in people with fertility problems. Certain methodologic limitations need to be taken into account. First, despite the multidisciplinary contributions from experts worldwide, focus groups, and a feasibility and acceptability study in 10 countries, the final psychometric evaluation occurred in only five English-speaking countries. Second, targeted efforts to recruit a diverse group of people were not entirely successful for particular subgroups (namely, secondary infertility, men). Indeed, more psychometric research on men is required to fully establish reliability and validity. Third, the major proportion of the final sample was recruited online, and differences between the online and clinical samples were observed. Although data generated online has been shown to be as valid as data collected through traditional methods 15, 16, one would need to determine whether the differences observed warrant more in-depth analysis, for example, a different set of norms for clinical samples. We eliminated records coming from the same IP address, but it may be possible that the same person replied more than once to the survey. Finally, the subscales of the Core FertiQoL were not entirely orthogonal with cross-loadings on the social and mind/body domains. Because these associations were expected, we have now modified the final wording of four FertiQoL items to reduce these cross-loadings. Further evaluation of these changes and FertiQoL as a whole on a new sample is required for final validation. These main limitations should be addressed in future psychometric research evaluating FertiQoL. However, the strengths of our mixed-methods approach and consultation with and evaluation from infertile people ensures that FertiQoL captures the key life domains affected by fertility problems. It is hoped that FertiQoL will become a gold standard for the measurement of QoL for individuals experiencing fertility problems, whether in treatment or not. FertiQol will be useful to clinicians and researchers alike. FertiQoL can be used to identify people at risk of impaired QoL so that psychosocial resources can be offered and subscale scores could identify the specific domains where intervention might be most beneficial. Recent research has shown a close correspondence between Core FertiQoL and standardized measures of anxiety and depression in a Dutch sample (17). The availability of FertiQoL in 20 languages will facilitate essential cross-cultural research particularly in developing nations 18, 19. However, whether cross-cultural differences exist, whether different populations have different mean scores, and whether separate cultural norms are needed are all important questions that need to be addressed in future research. A unique aspect of FertiQoL compared with other QoL measures is the optional 10-item treatment module. This module measures QoL in terms of treatment quality (interactions with staff, quality of information) and treatment tolerability (effects on mood, disruptions daily life). These subscales can be used to assess effectiveness of new treatments/medications, to monitor quality of services, and to optimize patient treatment experiences. Research has shown that quality of treatment and its tolerability are predictors of treatment satisfaction (7) and willingness to persist with treatment (20), the latter also shown in the present study. Furthermore, a recent large multicenter study showed a strong association between a high level of patient-centered care and favorable FertiQoL scores (21). However, the sensitivity of Treatment FertiQoL for these purposes needs to be investigated in clinical trials of new interventions. In conclusion, the overall aim of the FertiQoL project was to develop an international instrument to measure QoL in men and women experiencing fertility problems, with the collaboration of individuals experiencing fertility problems and international experts in the field. This objective was accomplished, and future use of FertiQoL will be essential to establish FertiQoL as an essential measurement tool for practice, research, health service evaluation, and policy making.

Infertility-specific questionnaires.

AuthorNameDevelopment sampleContent
Negative affect, distress and strain
 Bernstein et al., 1985, USA (1)Infertility QuestionnaireMiddle class, patientsSelf-image, guilt/blame, sexuality, negative feelings, thoughts about infertility
 Keye et al., 1984 (unpublished); Collins et al., 1992, USA (2)Infertility Reaction ScaleMiddle class, ARTNeed for parenthood, social and work efficiency, social pressure to have a child
 Newton et al., 1999, Canada (3)Fertility Problem InventoryMiddle class, patientsStrain or stress in social, sexual, relationship domain, need for parenthood, rejection of child-free living
 Verhaak et al., 2010, The Netherlands (4)SCREENIVFSubsidized ART, womenMood, helplessness, acceptance
 Abbey et al., 1991, USA (5)Fertility Problem Stress InventoryInfertile couplesInfertility stress
 Stanton et al., 1991, USA (6)Infertility Feelings QuestionnairePatientsNegative feelings in relation to infertility
Treatment-specific
 Boivin and Takefman, 1995, Canada (8)Daily Record-Keeping SheetMiddle class, ART patientsNegative (depression, anxiety, uncertainty) and positive affect and coping during treatment
 Pook et al., 1999, GermanyInfertility Distress ScaleAndrology, menDistress mainly due to infertility & childlessness
 Franco et al., 2002, Brazil (9)Psychologic evaluation test after ARTART patientsNegative reactions to specific aspects of ART
 Klonoff-Cohen and Natarajan, 2004, USA (10)Concerns about reproductive technologiesProfessional women, ARTLevel of concern about different aspects of ART: procedural (e.g., side effects, anesthetics), treatment failure, disruption to work, financial considerations
 Benyamini et al., 2005, Israel (11)Difficulty with infertility and its treatmentPatients (early stage)Significance of 22 difficulties in four domains (uncertainty/lack of control, family and social pressures, impact on self-spouse, treatment-related problems)
Quality of life
 Cronin et al., 1998, USA (12)Polycystic Ovary Syndrome Quality of LifePCOS patientsQuality of life in five domains (emotions, body hair, weight, infertility, menstrual problems)
 Jones et al., 2001, UK, (13)Endometriosis Health Profile–30Endometriosis, support groupSymptoms in five domains (pain, control and powerlessness, emotional well-being, social support, self-image)
 Schanz et al., 2005, Germany (14)Quality of life in infertile menMen attending andrology clinicFunctioning in four domains (desire for a child, sexual relationship, gender identity, psychologic well-being)

Note: Measures of infertility cognitions and/or motivation not shown. ART = assisted reproductive technologies (ART); PCOS = polycystic ovary syndrome.

  28 in total

1.  Global cultural and socioeconomic factors that influence access to assisted reproductive technologies.

Authors:  G David Adamson
Journal:  Womens Health (Lond)       Date:  2009-07

2.  The World Health Organization Quality of Life assessment (WHOQOL): position paper from the World Health Organization.

Authors: 
Journal:  Soc Sci Med       Date:  1995-11       Impact factor: 4.634

3.  The Fertility Problem Inventory: measuring perceived infertility-related stress.

Authors:  C R Newton; W Sherrard; I Glavac
Journal:  Fertil Steril       Date:  1999-07       Impact factor: 7.329

Review 4.  Infertility and psychological distress: a critical review of the literature.

Authors:  A L Greil
Journal:  Soc Sci Med       Date:  1997-12       Impact factor: 4.634

5.  Cognitive appraisal and adjustment to infertility.

Authors:  A L Stanton; H Tennen; G Affleck; R Mendola
Journal:  Women Health       Date:  1991

6.  Perceptions of infertility and treatment stress in females as compared with males entering in vitro fertilization treatment.

Authors:  A Collins; E W Freeman; A S Boxer; R Tureck
Journal:  Fertil Steril       Date:  1992-02       Impact factor: 7.329

7.  Reasons for dropout in an in vitro fertilization/intracytoplasmic sperm injection program.

Authors:  Jesper M J Smeenk; Christianne M Verhaak; Annette M Stolwijk; Jan A M Kremer; Didi D M Braat
Journal:  Fertil Steril       Date:  2004-02       Impact factor: 7.329

8.  The concerns during assisted reproductive technologies (CART) scale and pregnancy outcomes.

Authors:  Hillary Klonoff-Cohen; Loki Natarajan
Journal:  Fertil Steril       Date:  2004-04       Impact factor: 7.329

9.  Stress level across stages of in vitro fertilization in subsequently pregnant and nonpregnant women.

Authors:  J Boivin; J E Takefman
Journal:  Fertil Steril       Date:  1995-10       Impact factor: 7.329

Review 10.  Infertility and the provision of infertility medical services in developing countries.

Authors:  Willem Ombelet; Ian Cooke; Silke Dyer; Gamal Serour; Paul Devroey
Journal:  Hum Reprod Update       Date:  2008-09-26       Impact factor: 15.610

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  37 in total

1.  The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome.

Authors:  Richard S Legro; Allen R Kunselman; Robert G Brzyski; Peter R Casson; Michael P Diamond; William D Schlaff; Gregory M Christman; Christos Coutifaris; Hugh S Taylor; Esther Eisenberg; Nanette Santoro; Heping Zhang
Journal:  Contemp Clin Trials       Date:  2012-01-13       Impact factor: 2.226

2.  Predictors of quality of life and psychological health in infertile couples: the moderating role of duration of infertility.

Authors:  Maria Clelia Zurlo; Maria Francesca Cattaneo Della Volta; Federica Vallone
Journal:  Qual Life Res       Date:  2018-01-06       Impact factor: 4.147

3.  Fertility Related Quality of Life, Gonadal Function and Erectile Dysfunction in Male Partners of Couples with Unexplained Infertility.

Authors:  R Matthew Coward; Christy Stetter; Allen Kunselman; J C Trussell; Mark C Lindgren; Ruben R Alvero; Peter Casson; Gregory M Christman; Christos Coutifaris; Michael P Diamond; Karl R Hansen; Stephen A Krawetz; Richard S Legro; Randal D Robinson; James F Smith; Anne Z Steiner; Robert A Wild; Heping Zhang; Nanette Santoro
Journal:  J Urol       Date:  2019-07-08       Impact factor: 7.450

4.  Fertility-related quality of life from two RCT cohorts with infertility: unexplained infertility and polycystic ovary syndrome.

Authors:  Nanette Santoro; Esther Eisenberg; J C Trussell; LaTasha B Craig; Clarisa Gracia; Hao Huang; Ruben Alvero; Peter Casson; Gregory Christman; Christos Coutifaris; Michael Diamond; Susan Jin; Richard S Legro; Randal D Robinson; William D Schlaff; Heping Zhang
Journal:  Hum Reprod       Date:  2016-07-07       Impact factor: 6.918

5.  Reproductive Health in Women with Physical Disability: A Conceptual Framework for the Development of New Patient-Reported Outcome Measures.

Authors:  Claire Z Kalpakjian; Jodi M Kreschmer; Mary D Slavin; Pamela A Kisala; Elisabeth H Quint; Nancy D Chiaravalloti; Natalie Jenkins; Tamara Bushnik; Dagmar Amtmann; David S Tulsky; Roxanne Madrid; Rebecca Parten; Michael Evitts; Carolyn L Grawi
Journal:  J Womens Health (Larchmt)       Date:  2020-05-19       Impact factor: 2.681

6.  The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial.

Authors:  Richard S Legro; Robert G Brzyski; Michael P Diamond; Christos Coutifaris; William D Schlaff; Ruben Alvero; Peter Casson; Gregory M Christman; Hao Huang; Qingshang Yan; Daniel J Haisenleder; Kurt T Barnhart; G Wright Bates; Rebecca Usadi; Richard Lucidi; Valerie Baker; J C Trussell; Stephen A Krawetz; Peter Snyder; Dana Ohl; Nanette Santoro; Esther Eisenberg; Heping Zhang
Journal:  Fertil Steril       Date:  2013-10-21       Impact factor: 7.329

7.  Resilience in infertile couples acts as a protective factor against infertility-specific distress and impaired quality of life.

Authors:  Darja Herrmann; Horst Scherg; Rolf Verres; Cornelia von Hagens; Thomas Strowitzki; Tewes Wischmann
Journal:  J Assist Reprod Genet       Date:  2011-09-08       Impact factor: 3.412

8.  Assessment of multiple intrauterine gestations from ovarian stimulation (AMIGOS) trial: baseline characteristics.

Authors:  Michael P Diamond; Richard S Legro; Christos Coutifaris; Ruben Alvero; Randal D Robinson; Peter Casson; Gregory M Christman; Joel Ager; Hao Huang; Karl R Hansen; Valerie Baker; Rebecca Usadi; Aimee Seungdamrong; G Wright Bates; R Mitchell Rosen; Daniel Haisonleder; Stephen A Krawetz; Kurt Barnhart; J C Trussell; Yufeng Jin; Nanette Santoro; Esther Eisenberg; Heping Zhang
Journal:  Fertil Steril       Date:  2015-02-20       Impact factor: 7.329

9.  Infertility Specific Quality of Life and Gender Role Attitudes in German and Hungarian Involuntary Childless Couples.

Authors:  R E Cserepes; A Bugán; T Korösi; B Toth; S Rösner; T Strowitzki; T Wischmann
Journal:  Geburtshilfe Frauenheilkd       Date:  2014-11       Impact factor: 2.915

10.  Predictors of pregnancy and live-birth in couples with unexplained infertility after ovarian stimulation-intrauterine insemination.

Authors:  Karl R Hansen; Amy Linnea W He; Aaron K Styer; Robert A Wild; Samantha Butts; Lawrence Engmann; Michael P Diamond; Richard S Legro; Christos Coutifaris; Ruben Alvero; Randal D Robinson; Peter Casson; Gregory M Christman; Hao Huang; Nanette Santoro; Esther Eisenberg; Heping Zhang
Journal:  Fertil Steril       Date:  2016-03-03       Impact factor: 7.329

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