A new quality-of-life measure for men experiencing involuntary childlessness

S. Schanz1,6, I.T. Baeckert-Sifeddine5, C. Braeunlich1, S.E. Collins2, A. Batra2, S. Gebert3, M. Hautzinger4 and G. Fierlbeck1

1 Departments of Dermatology, 2 Psychiatry and Psychotherapy,3 Gynaecology, Eberhard-Karls-University, D-72076 Tübingen, Germany, 4 Department of Clinical and Physiological Psychology, Eberhard-Karls-University, D-72072 Tübingen, Germany, and 5 Fertility Center Aalen D-73430 Aalen, Germany

6 To whom correspondence should be addressed. E-mail: stefan.schanz{at}med.uni-tuebingen.de


    Abstract
 Top
 Abstract
 Introduction
 Materials and methods
 Participants
 Results
 Discussion
 References
 
BACKGROUND: Infertility may considerably reduce quality-of-life. Many of the existing generic quality-of-life measures, which often focus on physical impairments, do not represent the specific complaints of infertile patients. In this article, we report on the development and validation of the TLMK (Tübinger Lebensqualitätsfragebogen für Männer mit Kinderwunsch), an instrument for measuring quality-of-life in male patients with involuntary childlessness. METHODS: The first version of the questionnaire, which consisted of 91 items, was administered to 275 men who attended andrology and gynaecology clinics for fertility evaluations. After the questionnaires were scored, item analysis and reduction, principal component analysis and internal consistency analyses were conducted. RESULTS: The final version of the TLMK consists of 35 items in four scales and provides an internally consistent quality-of-life profile for men experiencing involuntary childlessness. Convergent and discriminant validity was supported through the correlation of the TLMK scales with established questionnaires on life satisfaction (FLZ) and partnership (PFB). CONCLUSION: The TLMK provides information about the quality-of-life in men experiencing involuntary childlessness and was found to be easy to administer and acceptable to patients. It may be used to assess patients’ baseline and ongoing quality-of-life during fertility treatment and as an outcome variable in the evaluation of integrated psychological counselling.

Key words: male infertility/quality-of-life/questionnaire development


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Participants
 Results
 Discussion
 References
 
Infertility is a major life crisis for many couples (Leiblum and Greenfield, 1997Go). It can cause emotional stress and a range of psychological reactions including depression and anxiety (Wischmann et al., 2001Go; Fassino et al., 2002Go; Chen et al., 2004Go), as well as jealousy, social isolation and, particularly in men, feelings of sexual inadequacy and sexual dysfunction (Irvine, 1996Go). However, couples may be affected by infertility in many different ways, which may depend on age, gender, stage of fertility treatment, or medical diagnosis.

General questionnaires are often used to assess depression, stress or anxiety in infertile patients (Cook, 1993Go; Dhillon et al., 2000Go; Wischmann et al., 2001Go). While these instruments offer valid and reliable measurement of patients’ general psychological state, these questionnaires may not represent all the unique problems of patients experiencing involuntary childlessness. It has also been pointed out that very few studies have included male partners in the assessment of problems encountered by infertile couples (Daniluk, 1997Go). Studies that have included both genders have indicated that the psychological response to infertility is different for men and women (Wright et al., 1991Go; Beutel et al., 1999Go; Hjelmstedt et al., 1999Go). Specifically, men appear to experience less psychological distress than women. Other studies, however, have demonstrated that male-factor infertility is more stressful for the couple than female-factor infertility (Mikulincer et al., 1998Go) and that the diagnosis of male-factor infertility may markedly impair men’s well-being (Kedem et al., 1990Go; Nachtigall et al., 1992Go). It has also been suggested that psychological distress may further decline semen quality (Clarke et al., 1999Go), although this finding has not been supported by other investigations (Schilling et al., 1999Go; Wischmann, 2003Go; Hjollund et al., 2004Go). Considering the mixed findings regarding men’s psychological response to infertility, further research must be conducted with instruments that are relevant, valid and reliable.

Quality-of-life assessment has been established in many medical disciplines as an important evaluation criterion. Although it is difficult to define quality-of-life, there is a scientific consensus that its assessment should include aspects of health status, psychological well-being, and physical and social functioning (Aaronson, 1988Go; Price, 1996Go). Based on these considerations, many generic instruments for the measurement of health-related quality-of-life have been developed in the last decade (Jenkinson et al., 1993Go; Power et al., 1999Go). These instruments, however, were predominantly designed for patients with diseases that result in impairment of physical functioning and reduced daily activity level, and thus do not address the specific problems encountered by patients experiencing involuntary childlessness.

Several questionnaires have been developed to assess different psychological issues surrounding infertility. Although these measures may provide physicians and researchers with helpful information concerning psychological adjustment (Glover et al., 1999Go), coping (Lee et al., 2000Go) and stress (Newton et al., 1999Go), no current questionnaires measure quality-of-life aspects from the perspective of male patients experiencing infertility. In discussing their own measure, the Fertility Problem Inventory (FPI), Newton et al. (1999)Go indicate that potential gender differences in coping with infertility and a potential lack of sensitivity to male concerns may complicate the assessment of infertility-related stress. The FPI, however, does not take into account gender-specific differences.

Further, the ‘fertility adjustment scale’ (FAS) (Glover et al., 1999Go), which assesses psychological adjustment to infertility, does not assess general quality-of-life aspects but rather focuses on ‘desire to have a child.’ Moreover, this questionnaire does not include gender-specific items. The interpretability of this instrument is also limited by the fact that the published article does not include a principal components analysis to preliminarily assess scale validity. The Coping Scale for Infertile Couples was developed to assess coping with infertility within the context of a couple’s relationship (Lee et al., 2000Go). This research team also acknowledges that the responses of husbands and wives on various scales of their instrument reflect a clear gender difference in coping with infertility. These findings suggest that a gender-specific measure may be important to fully capture the impact of infertility on quality-of-life.

Questionnaires in the German literature, such as the Desire to Have a Child Questionnaire (FKW; Hölzle and Wirtz, 2001Go) and the Questionnaire on Motives for Wanting Children (LKM; Brähler et al., 2001Go), were developed to assess reasons for wanting a child and expectations of parenthood. The Infertility Distress Scale (Pook and Krause, 2002Go) was designed and evaluated to measure infertility related distress. These questionnaires, however, do not focus specifically on the effects of infertility on patients’ quality-of-life. Thus, although other measures addressing the topic of infertility and related psychological factors have been made available in the literature, physicians and researchers may benefit from a questionnaire that assesses a range of quality-of-life aspects and takes into account a gender-specific perspective on infertility. The goal of the current study was therefore to design and assess a quality-of-life questionnaire for men facing infertility.


    Materials and methods
 Top
 Abstract
 Introduction
 Materials and methods
 Participants
 Results
 Discussion
 References
 
TLMK development
The questionnaire was developed in three steps. First, 10 patients participated in semi-structured interviews conducted by two andrologists at the andrology clinic in Tübingen, Germany. Patients were asked which infertility-related problems affected their daily life. Based on the information collected in these interviews and a systematic review of the scientific literature, eight infertility and quality-of-life domains were defined: psychological well-being; social contacts; physical complaints; partner relationship; sexual relationship; desire for a child; gender identity; and treatment satisfaction. In a second step, four clinical experts (two andrologists and two gynaecologists) selected and, where necessary, translated 120 items from general quality-of-life instruments, including the Munich Quality-of-life Dimension List (MLDL; Heinisch et al., 1991) and the semi-structured interviews, which dealt with the previously defined domains found in the infertility literature review (Connolly et al., 1992Go; Cook, 1993Go; Muller et al., 1999Go; Schilling et al., 2000Go). Following a review for item redundancy, a pool of 91 items was submitted. Finally, the four clinical experts worked independently to subjectively categorize the selected items into the eight rationally derived scales. Differences in the ratings were discussed and agreement reached about the categorization.

The resulting Tübingen Quality-of-life Questionnaire for Men with Involuntary Childlessness (Tübinger Lebensqualitätsfragebogen für Männer mit Kinderwunsch, TLMK) was designed to assess quality-of-life over a four-week time frame. Responses were made on a 1 to 5 Likert scale with the score of ‘1’ representing a low and ‘5’ a high level of agreement with the item; higher overall scores indicate a lower quality-of-life. To minimize response bias, some items were reverse coded (marked with an * in Table II). To maximize the acceptability of the questionnaire, special attention was aimed at the appropriateness and comprehensiveness of item wording. Two additional, open-ended items at the end of the questionnaire assessed participants’ opinions about the relevance and acceptability of the TLMK. The question ‘Were any important aspects of involuntary childlessness not covered by this questionnaire?’ was posed to establish whether major areas affected by involuntary childlessness were assessed by the instrument. The question ‘Did you find any questions to be uncomfortable?’ obtained information about patient acceptability of the questionnaire.


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Table II. Item analysis and internal consistency of the final questionnaire

 


    Participants
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 Abstract
 Introduction
 Materials and methods
 Participants
 Results
 Discussion
 References
 
The first version of the TLMK was tested on male patients who attended the andrology and gynaecology clinics at the University of Tübingen Medical Centre. Of the eligible patients (n = 400), 275 participants (68.75%) gave informed consent and completed the study. The mean age was 35.1 years. On average, participants had been trying to conceive for 3.9 years (see Table I for sociodemographic characteristics). A few patients (n = 39; 14%) had experienced assisted reproduction techniques previously but, for most participants, this was the beginning of the infertility diagnostic phase. Participants fulfilled the following criteria: sufficient knowledge of the German language; and presence of involuntary childlessness for at least half a year. Because we wanted to include patients in the primary diagnostic phase, we accepted participants experiencing at least 6 months of involuntary childlessness (or trying to conceive) instead of adhering to the World Health Organization (WHO) definition of a one-year duration. Only six patients (2%), however, had been trying to conceive for less than one year (four patients for 9 months and two patients for 6 months).


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Table I. Sociodemographic characteristics of the participants

 

The exclusion criterion in this study was the presence of a severe psychiatric disorder, which was assessed by asking patients whether they had a current or lifetime diagnosis of a severe psychiatric disorder. As no participants met this exclusion criterion, all participants who gave informed consent were invited to participate and were included in these analyses.

Additional measures
A sociodemographic questionnaire was designed for the current study to assess participants’ age, duration of involuntary childlessness, educational level and marital status.

The questionnaire of partnership (PFB; Hahlweg et al., 1982Go) assesses general quality of partnership. It consists of 30, four-point items, which are categorized into the three scale

s: conflict behaviour; tenderness; and communication. On the scale conflict behaviour, higher scores indicate less satisfaction with the partnership, while on the scales tenderness and togetherness/communication, higher scores indicate more satisfaction with the partnership. Previous analyses have evinced adequate scale reliability, with Cronb{alpha}ch’s ranging from 0.88 to 0.93 and six-month test–retest reliability ranging from r = 0.68 to 0.83 (Hahlweg et al., 1982Go).

The questionnaire of life satisfaction (FLZ; Fahrenberg et al., 2000Go) assesses satisfaction with a variety of aspects of daily life, particularly in connexion with the subjective experience of illness. Seventy, seven-point items are grouped into 10 scales: health; professional life; financial situation; leisure and hobbies; marriage and partnership; self-esteem; sexuality; social life; relationship to own children; and living situation. Higher scores indicate more satisfaction with the respective areas. Cronb{alpha}ch’s ranges from 0.82 to 0.94 for the individual scales (Fahrenberg et al., 2000Go). For this study, the scales relationship to own children and living situation were excluded because they did not seem appropriate for our patient group. The instruments PFB and FLZ were used to establish convergent validity for the current questionnaire.

Procedure
Physicians in the andrology and gynaecology clinics recruited interested participants during their first fertility appointment. After obtaining informed consent, physicians gave participants the questionnaire packet, instructed them to respond to the questionnaires openly and independently, and to mail them back anonymously or put them in a box in the clinic especially prepared for this procedure.


    Results
 Top
 Abstract
 Introduction
 Materials and methods
 Participants
 Results
 Discussion
 References
 
Item analysis and item discrimination
The response rate for each item did not fall below 97.5%. In the assessment of item discrimination, part/whole correlations were conducted for the single items to the total scale into which the item was categorized. For this criterion, a coefficient of r = 0.40 is generally considered sufficient (Nie et al., 1970Go; Bortz and Döring, 2002Go). Items with r < 0.40 were eliminated; this reduced the number of items from 91 to 53 (see Table II).

Measure acceptability
The two open-ended questions at the end of the instrument concerning the relevance and acceptability of the questionnaire were answered by 136 patients (49.5%). In response to these questions, only six participants criticised aspects of the questionnaire or made suggestions for modifications.

Factor structure
Exploratory factor analysis was employed using the principal component analysis (PCA) method with a varimax rotation and extraction of factors with Eigenvalues >1. All items evincing good discrimination value (see section headed Item analysis and item discrimination) were included in the factor analysis. Analyses indicated that 12 factors were extracted and accounted for 65% of the variance. Consistent factor loadings were demonstrated (Table III) for the preselected scales: desire for a child (Eigenvalue 15.03); sexual relationship (Eigenvalue 3.90); gender identity (Eigenvalue 3.12); physical complaints (Eigenvalue 1.29); treatment satisfaction (Eigenvalue 1.10); and social contacts (Eigenvalue 1.03). Apart from the partner relationship items, which loaded on three different factors (Eigenvalues 1.90, 1.73 and 1.35) and the items 6, 11 and 12 of the psychological well-being scale (Eigenvalue 1.81), items loaded consistently on the factors into which they were originally categorized.


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Table III. Matrix of the PCA using varimax rotation with Kaiser normalization

 

An item re-categorization was performed based on the factor loadings. It is generally agreed that factor loadings >0.32 are sufficient to establish factor membership (Tabachnick and Fidell, 2001Go) and items loading below this point were eliminated (see Table III for factor loadings). The PCA indicated that items 6, 11 and 12 had the highest factor loadings on the first factor and were therefore excluded from the psychological well-being scale and included in the desire for a child scale. Items 48 and 49 were excluded because they did not show relevant factor loadings for the scales into which they had been categorized and the items’ face validity seemed inappropriate for the factors they loaded on. Physical complaints, social contacts and treatment satisfaction scales consisted of only two items each and were therefore eliminated. The items of the partner relationship scale loaded on three different factors. This scale was therefore excluded due to its empirical inconsistency. The final version of the questionnaire consists of 35 items in four scales, all showing acceptable factor loadings (lowest value 0.36).

Most intercorrelations between the final TLMK scales were moderate in size (Table IV). A high intercorrelation was found between the scales desire for a child and gender identity (r = 0.69). However, the items of both scales clearly loaded on different factors in the PCA with the exception of item 24, which loaded on factor 1 (desire for a child; loading = 0.56) and factor 3 (gender identity; loading = 0.60), see Table III.


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Table IV. Correlation of TLMK, FLZ and PFB scales

 

Reliability
Internal consistency is an important criterion of reliability and is reflected in the coefficient Cronb{alpha}ch’s (Cronb{alpha}ch, 1951Go). By convention, values for Cronb{alpha}ch’s >0.70 indicate acceptable internal consistency of a scale (Bortz and Döring, 2002Go). As shown in Table II, the four scales of the TLMK showed good internal consistency, with Cronbach’s coefficients ranging from 0.83 (sexual relationship) to 0.92 (desire for a child).

Convergent and discriminant validity
In order to establish convergent and discriminant validity for the TLMK, correlations between selected scales of the TLMK and the FLZ and PFB were considered (see Table IV for all correlations). Given the large number of tests included, a Bonferroni correction was applied to correct for potential {alpha} inflation. The corrected significance level for P = 0.05 was P = 0.001. It should be noted that higher scores on the FLZ scales and the PFB tenderness and togetherness/communication scales indicate positive statements and that higher scores on the TLMK scales and the PFB scale conflict behaviour indicate negative statements.

Convergent validity
People with higher scores on the FLZ scale sexuality report more positive views of their physical attractiveness and are more satisfied with their sexual contacts and sexual relationship (Fahrenberg et al., 2000Go). We therefore hypothesized a negative correlation with the TLMK scale sexual relationship, which our analyses confirmed. The FLZ scalesexuality was also negatively correlated with the TLMK scale gender identity, which measures aspects of sexual functioning and gender role (see Table IV for correlations). High scores on the FLZ scale self-esteem indicate satisfaction with outward appearance, skills, vitality and self-view, whereas low scores indicate physical impairment and depressed mood (Fahrenberg et al., 2000Go). Thus, the negative correlation of this scale with the TLMK scale psychological well-being met our expectations (see Table IV). The PFB scale togetherness/communication assesses a couple’s common activities and focuses on solidarity and communication skills (Hahlweg et al., 1982Go). Because this scale reflects the common goal of conceiving a child, the negative correlation with the TLMK scale desire for a child met our expectations. The TLMK scales desire for a child and gender identity showed moderate correlations with the PFB scale tenderness, which assesses verbal and physical acts of tenderness between partners. The conflict behaviour scale of the PFB measures a behavioural style that works against conflict resolution. It was hypothesized that this scale would be moderately positively correlated with the sexual relationship scale of the TLMK, and this moderate correlation was observed in the current sample (r = 0.38). The above correlations indicated relationships between some of these scales, but these were moderate in size indicating that the scales represent separate dimensions. Thus, these correlations support the convergent validity between the TLMK scales and related constructs.

Discriminant validity
Because they measure dissimilar constructs, the FLZ scales professional life, financial situation, and leisure and hobbies were not expected to correlate with the TLMK subscales of desire for a child and sexual relationship. In fact, professional life evinced moderate correlations with the TLMK scale scores (see Table IV). However, the correlations between the TLMK scales desire for a child and sexual relationship, and the FLZ scales, financial situation and leisure and hobbies, were not significantly correlated. These findings partially support the TLMK’s discriminant validity.


    Discussion
 Top
 Abstract
 Introduction
 Materials and methods
 Participants
 Results
 Discussion
 References
 
The current study is a report on the development of the TLMK, a questionnaire for measuring quality-of-life specific to men experiencing involuntary childlessness. This instrument contains 35 items and consists of four scales: psychological well-being; sexual relationship; desire for a child; and gender identity.

Preliminary psychometric evaluation showed good internal consistency for the four scales. Construct validity was supported by exploratory factor analysis and item-total scale correlations, while convergent and discriminant validity were partially supported by correlations of the TLMK scales with related constructs from other established instruments, specifically the PFB (Hahlweg et al., 1982Go) and the FLZ (Fahrenberg et al., 2000Go). The TLMK was also easy to administer and acceptable to patients.

The TLMK provides a potentially helpful addition to the previously published questionnaires in the literature (Bernstein et al., 1985Go; Glover et al., 1999Go; Newton et al., 1999Go). The TLMK assesses quality-of-life in connection with male infertility from a male perspective. The exclusively male sample and gender-specific items involved in this study address the problem highlighted by Lee et al. (2000)Go and Newton et al. (1999), i.e. that potential gender differences in coping with infertility and a lack of sensitivity to gender-specific concerns may obscure the psychological impact of childlessness and infertility. Further trials are currently being conducted to demonstrate differences between the TLMK and a variation of the measure tailored to women. They will also explore whether: (i) these questionnaires are able to discriminate among different patient groups (e.g. between cases of male- and female-factor infertility or among different infertility treatment procedures); and (ii) the instruments are sensitive enough to reflect changes in quality-of-life during the course of treatment (e.g. after treatment failure).

Some limitations of the current study and the TLMK warrant mention. First, analyses revealed low mean scores for most of the scales (Table II). This finding was particularly surprising in the case of sexual relationship and gender identity. It is possible that social desirability influenced participants’ responses, especially given the personal nature of these topics. This effect has been documented previously and particularly for responses at the beginning of infertility treatment (Berg, 1994Go), which was the case in our study. That being said, our observations are consistent with some reports in the literature. In a recent study, Wischmann et al. (2001)Go found few score differences between infertile couples and a reference population on the Partnership Questionnaire (PFB), the Life Satisfaction Questionnaire (FLZ), the Symptom Checklist (SCL-90-R), and the Giessen test (GT). Moreover, several investigations found gender differences on infertility-related distress and quality-of-life, and indicated that women may be more affected by infertility than men (Andrews et al., 1991Go; Stanton et al., 1991Go; Newton et al., 1999Go; Goldschmidt et al., 2003Go).

The relatively low mean scale scores may also have resulted from a lack of instrument sensitivity for this population. On the other hand, select items displayed relatively high means, and may thus represent marked impairments in specific areas of quality-of-life (e.g. report of difficulties relaxing, feeling distressed by infertility). Further validation studies with TLMK will have to be conducted with a reference population to establish general population norms for this measure and to allow for further tests of instrument sensitivity and criterion validity. Future studies may also compare information assessed by general quality-of-life measures and the TLMK to determine whether the infertility-specific nature of the measure provides unique and useful information about men with involuntary childlessness.

Next, it should be noted that the average education level of participants in this study was relatively high (42% university-entrance diploma), which may call into question the representative nature of this sample. However, this proportion is representative of the population of male patients typically undergoing infertility diagnosis in the University of Tübingen Medical Centre andrology clinic, of whom 35–43% report having this level of education.

The final version of the TLMK questionnaire contains many elements of infertility-related distress. Other facets of quality-of-life covered by general measures, such as physical complaints or social contacts, may appear under-represented. Although these aspects were included in the primary item pool, most did not meet the item entry criterion (discrimination value >0.40). The distress reflected in some areas of quality-of-life as measured by the TLMK may be more relevant to male patients experiencing involuntary childlessness than those included in general quality-of-life questionnaires. In order to confirm the male-specific nature of the questionnaire, a future study will need to compare the factor structure across gender using, for example, a multiple-group confirmatory factor analysis.

Unlike some other infertility questionnaires, the TLMK does not contain a personal relationships’ factor, although aspects of this field are included in the desire for a child and sexual relationship scales. Some items pertaining to personal relationships (i.e. social contacts scale) were included in the original measure but did not meet the entry criterion in the item selection. After the factor analysis, the social contacts scale consisted of only two items and was therefore excluded from the TLMK. The exclusion of the social contacts scale may be a methodological artefact and future studies may further evaluate the importance of such a scale.

The results of this study revealed lower than expected scores and thus support the premise that men experiencing involuntary childlessness should be de-pathologized (Boivin et al., 2001Go). However, the results also indicate that some patients are vulnerable to certain sources of psychological distress. The current study has revealed important aspects of patients’ psychological well-being that should be assessed regularly during infertility evaluation and treatment. If necessary, such problems may be addressed by referral to psychological treatment according to the guidelines established in this field (Boivin et al., 1995Go).

This study introduced the TLMK, a new questionnaire for measuring quality-of-life in male patients experiencing involuntary childlessness and represented the first step in the psychometric evaluation of the TLMK. The questionnaire evinced adequate internal consistency as well as construct, discriminant and convergent validity. Future studies may establish further psychometric properties of this measure such as sensitivity to detect change and criterion validity. This questionnaire may be integrated into research and clinical batteries to establish baseline levels of quality-of-life for these patients and to evaluate the efficacy of psychological interventions designed to improve their quality-of-life.


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 Introduction
 Materials and methods
 Participants
 Results
 Discussion
 References
 
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Submitted on August 6, 2004; resubmitted on May 3, 2005; accepted on May 13, 2005.





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