Cross-cultural adaptation and validation of a French version of the perceived personal control questionnaire as an outcome measure instrument for genetic counseling
Abstract
The perceived personal control (PPC) questionnaire serves as an instrument to assess the concept of PPC, which refers to a person's perception of their ability to achieve positive outcomes while avoiding the negative effects of a given situation. Developed and used as a patient-reported outcome measure (PROM) in genetic counseling, the PPC questionnaire has been translated and validated in several languages, but not in French. The aim of this study was to cross-culturally adapt and validate a French version of the PPC questionnaire to evaluate genetic counseling services for hereditary breast and ovarian cancer (HBOC). After the translation into French, cognitive interviews were conducted with nine participants who had attended genetic counseling for HBOC to examine the adequacy of this French version and to verify participants' understanding of the questionnaire items. Cognitive interview data suggested that slight modifications should be made to four of the nine items and that it would be beneficial to add a short introduction to ensure that participants' interpretation corresponded to the intended meaning. Psychometric validation was then conducted with 99 participants who had also attended genetic counseling for HBOC. Counselees completed the questionnaire before and after their genetic consultation. The acceptability of the questionnaire was demonstrated by the presence of few missing items. The original three-factor solution was not confirmed by our exploratory factor analysis, suggesting that the questionnaire should be used as a one-dimensional instrument. The internal consistency of the questionnaire was high, with Cronbach's alpha of 0.89 before genetic counseling and 0.88 after. The significant increase in PPC scores before and after genetic counseling supports the responsiveness of the questionnaire. Convergent validity was confirmed by positive association with counselees' satisfaction with genetic counseling. These properties suggest the French PPC questionnaire is a valuable instrument for use as a PROM in genetic counseling research.
What is known about this topic
Perceived personal control (PPC) is a desired outcome of genetic counseling services, and the PPC questionnaire has proved to be a useful instrument for research and service evaluation. This instrument has not yet been cross-culturally adapted and validated for use in a French–Canadian population.
What this paper adds to this topic
This is the first study to cross-culturally adapt and validate the PPC questionnaire for use in a French–Canadian population.
1 INTRODUCTION
Genetic counseling is a communication process based on genetic information that aims to help patients understand and adapt to the medical, psychological, and familial implications of a potential genetic disease in a personally meaningful way (Resta et al., 2006). Genetic counseling for cancer predisposition has been shown to be effective in reducing psychological distress and improving a counselees' knowledge and perception of their own cancer risk (Trepanier & Allain, 2014). Assessing counselees' acquisition of knowledge is important, as the communication of factual information is the most frequent interaction between the genetic counselors and counselees (Davey et al., 2005). However, genetic counseling is also a psychoeducational process that aims to facilitate counselees' ability to adapt psychologically to the genetic information provided and to use genetic information in ways that minimize psychological distress and increase personal control (Biesecker & Peters, 2001; Shiloh et al., 1997; Walker, 2011). As such, genetic counseling must be adapted to address issues of major loss-of-control experiences typical of individuals at risk for genetic disease (Thompson & Spacapan, 1991). Although genetic diseases are heterogeneous, they remain similar in terms of loss of control, as they share the characteristics of a threatening event that produces stress. Helping counselees regain a sense of control is therefore a central goal of genetic counseling. The use of psychological concepts such as perceived personal control (PPC) thus becomes relevant in assessing the effectiveness of genetic counseling (Kasparian et al., 2007).
The idea that a sense of control is essential to psychological well-being has been a major theme in psychology for over 30 years (Thompson & Spacapan, 1991). PPC is defined as “the belief that one can determine one's own internal states and behavior, influence one's environment, and/or bring about desired outcomes” (Wallston et al., 1987, p. 5). Many positive outcomes are associated with a sense of control, such as increased emotional well-being (Charms, 1983), successful stress management (Miller, 1979), good health (Peterson & Stunkard, 1989), and desirable behavior changes (Bandura, 1977). Several studies argue that when patients perceive greater control over their disease, symptoms, or treatment, they experience better recovery and emotional adjustment (Elliot et al., 2018; Infurna & Gerstorf, 2014; Robinson & Lachman, 2017; Taylor et al., 1984; Thompson et al., 1993). PPC also has the potential to impact the ability to cope with a medical threat in the context of genetic counseling. A higher sense of control predicts greater satisfaction with genetic counseling, the use of less emotion-focused coping strategies and the perceived ability to control the consequences associated with a medical condition (Shiloh et al., 1997). Patients also agree on the value of PPC as an outcome measure, with 88% of patients acknowledging its usefulness in a previous study (Payne et al., 2007). It is widely recognized that collecting direct feedback from patients is the most effective method for assessing the quality of care received (Cleary & Edgman-Levitan, 1997). Standardized and validated patient experience surveys are the primary tool for this purpose (Beattie et al., 2015). This method is also relevant to genetic counseling outcomes research, where patient-reported outcome measures (PROMs) are widely used and effective in providing evidence-based service evaluation (Redondo & McAllister, 2023). Therefore, systematic or periodic evaluation of genetic counseling services using PROMs is essential to determine whether these services meet patients' needs, including helping counselees increase their PPC (Davey et al., 2005).
The PPC questionnaire is an instrument used to evaluate the concept of PPC as a PROM. It was originally developed in Hebrew by Berkenstadt et al. (1999). Their aim was to develop an instrument that measures the concept of PPC to assess a broader and more meaningful range of genetic counseling outcomes, as most studies have traditionally focused on educational variables. To do this, they used Thompson's PPC concept and Averill's control typology to assess individuals' perception of their ability, resources, and opportunities to obtain positive outcomes from a particular situation while avoiding negative effects (Averill, 1973; Thompson & Spacapan, 1991). To date, the PPC questionnaire has been translated and validated into English (McAllister et al., 2012), Dutch (Smets et al., 2006) and Serbian (Cuturilo et al., 2016). These translated and validated versions have been used to evaluate genetic counseling interventions with diverse populations and issues. These include the use of the instrument to determine the effect of genetic counseling for melanoma risk management (Aspinwall et al., 2018), heart problems and hypertension (Sweet et al., 2014), coronary heart disease (Robinson et al., 2016), and fertility problems (Cuturilo et al., 2016). Other studies have also used the PPC questionnaire to assess the effects of genetic counseling on participants (Voorwinden & Jaspers, 2016), to test the effect of genetic counseling in conducting scientific research (Madlensky et al., 2017), and to determine the appropriateness of using genetic counseling as a means of preventing heart problems (Nieuwhof et al., 2017). The Dutch version was created for use in a counseling setting for hereditary cancer susceptibility and fertility problems (Smets et al., 2006).
Considering the value of PPC as an outcome measure for evaluating genetic counseling services, this study presents the cross-cultural adaptation and validation of a French version of the PPC questionnaire using a sample of patients consulting for hereditary breast and ovarian cancer (HBOC).
2 METHODS
2.1 Study design
The present study was carried out in two main phases: (1) cross-cultural adaptation of the PPC questionnaire in French and (2) evaluation of the psychometric properties of the French version of the questionnaire. The study protocol and recruitment materials were approved by the CHU de Québec-University Laval Institutional Review Board: Project 2020-4695 and Project 2022-6824.
Cross-cultural adaptation is a recognized multi-stage procedure aimed at obtaining translated versions of questionnaires that are equivalent not only linguistically but also culturally to the original versions (Guillemin et al., 1993). The cross-cultural adaptation of the questionnaire followed Beaton's guidelines which include the following stages: translation, synthesis, back translation, expert committee review, and pre-testing to gather and verify respondents' understanding (Beaton et al., 2000). For the pre-test stage, the cognitive interview method was used, incorporating the think-aloud and verbal probing techniques to enable the research team to analyze how participants understood the questionnaire items (Ryan et al., 2012). Cognitive interviewing is a highly effective method, as it ensures the adequacy of the translation of the pre-final version and verifies the respondents' understanding of the questions. This method also ensures that the meaning and interpretation of the questions remain similar for all respondents (Beatty & Willis, 2007; Messick, 1995; Ryan et al., 2012; Willis, 2004). The cognitive interviews' data were analyzed according to the recommendations of Knafl et al. (2007).
Inspired by the validation work undertaken for different versions of the PPC questionnaire (Berkenstadt et al., 1999; Cuturilo et al., 2016; McAllister et al., 2012; Smets et al., 2006), the following psychometric properties of the instrument were evaluated among participants who completed the questionnaire before and after genetic counseling: acceptability, reliability, dimensionality, and construct validity.
2.2 Participants
All participants came from the Breast Disease Clinic of the CHU de Québec—Université Laval, Québec, Canada. The clinic has three referral indications for genetic counseling: (1) being a member of a family where a variant for breast or ovarian cancer has been identified; (2) having a breast cancer history or diagnosis with indications for genetic testing; and (3) having a family history of breast or ovarian cancer with criteria for genetic testing (Centre des Maladies du Sein, 2021). We recruited participants who had attended an online group genetic counseling session for HBOC. For the cognitive interviews, participants were recruited between October 2020 and August 2022, with the option to complete the interview by teleconference or on the Zoom videoconferencing platform. To assess the psychometric properties of the questionnaire, participants were recruited between June and December 2023. They were asked to complete a web-based questionnaire both before and 15 days after their online group genetic counseling session, delivered by the Breast Disease Clinic.
2.3 Procedures
To obtain a French version of the PPC questionnaire, two French-speaking professional translators were asked to independently provide a French version of the questionnaire based on the English version. They were instructed to document any difficulties and hesitations encountered during the translation in order to explain their decision-making process and their proposed translations. A consensus meeting was then held with the research team to resolve discrepancies and agree upon a French version. This French version was then independently back translated into English by two professional English translators who had not consulted the original English version of the PPC questionnaire. This back translation allowed the research team to identify and address any minor discrepancies and agree on a pre-final French version. A linguist, member of the research team, compared the different versions, summarized the results, supported the consensus process, and revised the pre-final version. Then, cognitive interviews were conducted using the pre-final version. Two interviewers were involved, one acting as a facilitator and the other as note-taker. Interviews were conducted without audio recording in adherence of our protocol approved by our Institutional Review Board, with both interviewers collecting notes simultaneously in a shared document. Each interviewer maintained their designated role throughout all cognitive interviews. Participants were introduced to the interview process and instructed to read the PPC questionnaire aloud and to mention anything they are thinking when reading and answering an item. In the event of any misunderstanding or hitch, the interviewer addressed and clarified any wording issues with the participant. A discussion with participants followed to identify potential solutions to improve clarity, such as word changes, sentence reformulations, or elimination of parts.
For the evaluation of the psychometric properties, participants were asked to complete a web-based questionnaire before their genetic consultation and 15 days after. The pre-counseling questionnaire included the French version of the PPC questionnaire, as well as sociodemographic and medical questions. The post-counseling questionnaire also included the French version of the PPC questionnaire with the addition of the French version of the Genetic Counseling Satisfaction Scale (GCSS) (Villafane-Bernier et al., 2021). Data were collected via the REDCap platform (Harris et al., 2009).
2.4 Instruments
The PPC questionnaire comprises nine items with a three-point response scale (0 = do not agree, 1 = somewhat agree, 2 = completely agree). Based on Averill's tripartite structure for the concept of control (i.e., cognitive, decisional, and behavioral) (Averill, 1973), items one to three address the cognitive dimension by asking how the respondent processes information to reduce the impact of a stressful situation. Items four to six address the decision-making dimension, focusing on the respondent's perceived ability to choose among different courses of action. The last three items address the behavioral dimension, by asking respondents about their ability to take actions likely to directly influence or modify the stressful situation (Berkenstadt et al., 1999). A PPC total score (ranging from 0 to 2) is calculated by summing all nine item scores and diving by the total number of items. Higher scores indicate a greater degree of PPC.
The GCSS was used to measure participant satisfaction following genetic counseling for HBOC. The GCSS is a self-report instrument that provides an overall satisfaction score regarding the general aims of genetic counseling. Composed of six items, it assesses both the process and content of genetic counseling, indicating the degree to which participants agree with statements regarding their genetic counseling experience. Possible responses follow a five-point Likert scale ranging from “1 = Strongly disagree” to “5 = Strongly agree” (Villafane-Bernier et al., 2021).
2.5 Data analysis
The analysis of the cognitive interviews involved identifying elements that were problematic for the participant's understanding and grouping common difficulties. A report was generated for each questionnaire item, with all the participants' comments for each item. These reports were used to identify problematic items and the necessity for modifications (Knafl et al., 2007).
All statistical analyses were performed using the SAS software (version 9.4, SAS Institute Inc., Cary, NC, USA). Acceptability was assessed by examining the frequency of missing data. Reliability was established by examining internal consistency for the whole instrument and for the three subscales using a standardized Cronbach's alpha coefficient (Boateng et al., 2018). Since the Dutch, English, and Serbian validation did not support the three-factor structure (Cuturilo et al., 2016; McAllister et al., 2012; Smets et al., 2006) proposed by the original authors (Berkenstadt et al., 1999), we performed an exploratory factor analysis (EFA) to assess the dimensional structure of the instrument, as we wanted to explore whether there were other potential solutions that might fit better than the original three-factor solution. To assess validity, a convergent analysis with a parallel construct (satisfaction) was performed. Bivariate analyses were carried out to determine whether there were group differences in PPC scores for any sociodemographic or medical factors, as we expected that counselees with children or a cancer history might have a lower PPC scores. Additionally, comparisons of mean PPC scores pre- and post-counseling were conducted to support the questionnaire's responsiveness.
3 RESULTS
3.1 Step 1: Cognitive interviews
3.1.1 Cognitive interviews sample characteristics
As recommended by Beatty and Willis, cognitive interviews should be conducted in sets of five and should be repeated after each item revision (Beatty & Willis, 2007). Two sets of cognitive interviews were conducted on the pre-final French version of the PPC questionnaire: five in the first set and four in the second set, for a total of nine interviews. All participants attended a genetic counseling session at the request of a health professional for one of the following reasons: a personal breast cancer diagnosis, the presence of a variant in the family, or due to an important family history of breast cancer. Six of these interviews were conducted by teleconference and three by videoconference. All participants had already completed the French version of the PPC questionnaire a few days before the interview. All nine participants had either French as their first language or spoke it fluently.
3.1.2 Response analysis of the cognitive interviews
After the first set of cognitive interviews (n = 5), a meeting was held with the entire research team. The conclusion of this meeting was that slight modifications to the pre-final French version were required. The use of the term “problem” in four of the nine items, for example, “I feel there are certain things I can do to prevent the problem from recurring/J'ai l'impression de pouvoir faire certaines choses pour empêcher le problème de se reproduire,” made most participants uncomfortable. The research team, with the help of participant feedback, decided to remove this term and replace it with the more neutral term “situation.” The wording of the item 3, “I think I know the cause of the problem/Je pense connaître la cause du problème,” was also changed for “I think I know what caused this situation/Je pense savoir ce qui a causé cette situation” to make it easier to understand. The meaning of the item remained unchanged. Finally, the research team decided to add a brief introduction to the questionnaire to clarify what the term “situation” refers to, for example, identification of a genetic variant in a gene associated with cancer risk. The purpose of this introduction is to facilitate the understanding of the questionnaire items. These changes led to another set of cognitive interviews (n = 4). The results of these interviews indicated that this revised pre-final French version did not require any further modifications. Consequently, we proceeded with the validation work using this French version. Details related to participants' answers to the cognitive interviews are available from the corresponding author upon reasonable request.
3.2 Step 2: Validation with a larger sample
3.2.1 Validation sample characteristics
Participants (n = 99) were seen at the Breast Disease Clinic for an online genetic counseling group session between June 2023 and December 2023. They completed the web-based questionnaire 1 day prior to their genetic counseling session. The web-based post-counseling questionnaire was completed by 72 (72.7%) of the 99 counselees 15 days after their genetic counseling session. No significant statistical difference was found between the characteristics of respondents and non-respondents to the second questionnaire. The demographic and medical characteristics of the participants who completed the pre- and post-counseling questionnaires are presented in Table 1. Most participants were between 35 and 64 years of age (73.61%), were assigned female at birth (95.83%), identified as women (95.83%), and had a college or university diploma (68.06%). The majority had children (81.94%), and 52.78% had a history of cancer.
| N (%) | |
|---|---|
| Sex assigned at birth [missing values] | [0 (0.00)] |
| Male sex | 3 (4.17) |
| Female sex | 69 (95.83) |
| Gender [missing values] | [0 (0.00)] |
| Men | 3 (4.17) |
| Women | 69 (95.83) |
| Non-binary person | 0 (0.00) |
| Age [missing values] | [0 (0.00)] |
| Between 15 and 24 | 1 (1.39) |
| Between 25 and 34 | 6 (8.33) |
| Between 35 and 44 | 12 (16.67) |
| Between 45 and 54 | 27 (37.50) |
| Between 55 and 64 | 14 (19.44) |
| Between 65 and 74 | 10 (13.89) |
| 75 and more | 2 (2.78) |
| Children [missing values] | [0 (0.00)] |
| Has children | 59 (81.94) |
| Has no child | 13 (18.06) |
| Education [missing values] | [1 (1.39)] |
| No diploma | 3 (4.17) |
| High school diploma | 6 (8.33) |
| Trade school certificate or diploma | 13 (18.06) |
| College or CEGEP certificate or diploma | 22 (30.56) |
| University certificate, diploma, or degree | 27 (37.50) |
| Personal cancer history [missing values] | [0 (0.00)] |
| Yes | 38 (52.78) |
| No | 34 (47.22) |
3.2.2 Acceptability
To establish the acceptability of a questionnaire, it is recommended that the percentage of missing data should not exceed 10%. Above this threshold, missing data are considered significant, as they can distort the results of subsequent statistical analyses (Bennett, 2001). Additionally, if certain items are missed more frequently, this may indicate a potential problem with the item itself, such as a lack of clarity or relevance (Boateng et al., 2018). Percentages of missing items in the present study varied between 0 (n = 4) and 2.02 (n = 1) pre-counseling and 0 (n = 2) and 1.39 (n = 7) post-counseling (see Table 2), supporting that the PPC questionnaire was well accepted among participants. Two (2.02%) participants omitted one or more items pre-counseling and two (2.77%) post-counseling.
| Items | Pre-counseling | Post-counseling | |
|---|---|---|---|
| Final French version/original English version | N = 99 (%) | N = 72 (%) | |
| 1. | Je pense comprendre la situation qui m'a amené à consulter en oncogénétique/I think I understand what problem brought me to genetic counseling | 0.0 | 0.0 |
| 2. | Je crois comprendre ce que cette situation signifie pour moi et ma famille/I feel I know the meaning of the problem for my family's future and me | 0.0 | 0.0 |
| 3. | Je pense savoir ce qui a causé cette situation/I think I know what caused the problem | 1.01 | 1.39 |
| 4. | Je crois avoir les outils pour prendre des décisions qui vont influencer mon avenir/I feel I have the tool to make decisions that will influence my future | 1.01 | 1.39 |
| 5. | Je crois pouvoir bien évaluer les différentes options qui s'offrent à moi afin d'en choisir une/I feel I can make a logical evaluation of the various options available to me in order to choose one of them | 2.02 | 1.39 |
| 6. | Je me sens capable de prendre des décisions qui vont changer l'avenir de ma famille/I feel I can make decisions that will change my family's future | 0.0 | 1.39 |
| 7. | J'ai l'impression de pouvoir faire certaines choses pour empêcher la situation de se reproduire/I feel there are certain things I can do to prevent the problem from recurring | 0.0 | 1.39 |
| 8. | Je crois savoir quoi faire pour rendre la situation plus facile à vivre/I feel I know what to do to ease the situation | 1.01 | 1.39 |
| 9. | Je pense savoir ce que devraient être les prochaines étapes pour moi/I think I know what should be my next steps | 1.01 | 1.39 |
3.2.3 Reliability
Internal consistency was assessed before and after genetic counseling. It was assessed for the whole instrument and for each subscale of the original PPC questionnaire. Pre-counseling internal consistencies were 0.89 (total), 0.72 (cognitive control), 0.86 (decisional control), and 0.77 (behavioral control). For the post-counseling, the internal consistencies were very similar: 0.88 (total), 0.70 (cognitive control), 0.81 (decisional control), and 0.74 (behavioral control). These reliability scores can be considered satisfactory for the whole instrument and for decisional control subscale, but only reasonable for the cognitive and behavioral control subscales (Boateng et al., 2018) (see Table 3).
| Cronbach's alpha (internal consistency) | ||
|---|---|---|
| Pre-counseling | Post-counseling | |
| Cognitive control | 0.72 | 0.70 |
| Decisional control | 0.86 | 0.81 |
| Behavioral control | 0.77 | 0.74 |
| Total | 0.89 | 0.88 |
3.2.4 Dimensionality
The initial three-factor solution suggested by Berkenstadt explained 57% of the variance in the pre-counseling data and 53% in the post-counseling data. However, the three-factor solution did not reflect the three expected dimensions of the control concept: cognitive, decisional, and behavioral. Furthermore, the items' distribution in the pre-counseling data differed from that of the post-counseling data. Instead, our EFA suggested a two-factor solution for pre- and post-counseling data, accounting for 54% and 50% of the variance, respectively. Given that these results do not correspond to the three expected control dimensions, we recommend a one-factor solution. The one-factor solution explained 49% of the variance in the pre-counseling data and 46% in the post-counseling data (see Table 4).
| Items | Pre-counseling | Post-counseling | |
|---|---|---|---|
| Final French version/original English version | |||
| 1. | Je pense comprendre la situation qui m'a amené à consulter en oncogénétique/I think I understand what problem brought me to genetic counseling | 1.75 | 1.83 |
| 2. | Je crois comprendre ce que cette situation signifie pour moi et ma famille/I feel I know the meaning of the problem for my family's future and me | 1.59 | 1.77 |
| 3. | Je pense savoir ce qui a causé cette situation/I think I know what caused the problem | 1.32 | 1.45 |
| 4. | Je crois avoir les outils pour prendre des décisions qui vont influencer mon avenir/I feel I have the tool to make decisions that will influence my future | 1.36 | 1.61 |
| 5. | Je crois pouvoir bien évaluer les différentes options qui s'offrent à moi afin d'en choisir une/I feel I can make a logical evaluation of the various options available to me in order to choose one of them | 1.32 | 1.55 |
| 6. | Je me sens capable de prendre des décisions qui vont changer l'avenir de ma famille/I feel I can make decisions that will change my family's future | 1.42 | 1.64 |
| 7. | J'ai l'impression de pouvoir faire certaines choses pour empêcher la situation de se reproduire/I feel there are certain things I can do to prevent the problem from recurring | 1.19 | 1.30 |
| 8. | Je crois savoir quoi faire pour rendre la situation plus facile à vivre/I feel I know what to do to ease the situation | 1.16 | 1.40 |
| 9. | Je pense savoir ce que devraient être les prochaines étapes pour moi/I think I know what should be my next steps | 1.01 | 1.43 |
| Eigenvalue | 4.4 | 4.1 | |
| Percentage of variance explained | 49% | 46% | |
| Mean total score | 1.35 ± 0.48 | 1.55 ± 0.42 | |
3.2.5 Validity
Comparisons of mean PPC scores pre- and post-counseling showed significant increase after counseling (paired t = −3.92, df = 68, p < 0.001), supporting the questionnaire's responsiveness (see Table 4). Pre-counseling PPC scores were unrelated to counselees' sex assigned at birth, gender, age, having children, level of education, or cancer history. In terms of post-counseling scores, there was a significant difference for counselees with children or a cancer history. Counselees with children or a cancer history had a significantly lower mean PPC score than counselees without children or without a cancer history (Children: t = −2.09, df = 67, p < 0.05. Cancer: t = −2.27, df = 67, p < 0.05). Changes between pre- and post-counseling PPC scores were only significantly associated with having a cancer history, as the increase in PPC score was significantly lower for this group (paired t = −1.85, df = 67, p < 0.05). No other significant associations were found when examining score changes from pre- to post-counseling.
Analyses were also performed to assess the presence of associations between PPC scores and levels of satisfaction with genetic counseling. Counselees with children were significantly less satisfied with genetic counseling than counselees without children (t = −3.19, df = 33, p < 0.005). A higher post-counseling satisfaction score was significantly associated with a higher PPC score (r = 0.38, df = 68, p < 0.005). However, a higher post-counseling satisfaction score was not significantly associated with a change in PPC score between the pre- and post-counseling (r = 0.03, df = 68, p > 0.05).
4 DISCUSSION
In this study, we undertook a rigorous process of cultural adaptation and validation to obtain a French version of the PPC questionnaire, a questionnaire developed to assess subjective perceptions of the degree of control that genetic counselees have over the possibility of carrying a hereditary condition. Our objectives were to assess whether our French version of the PPC questionnaire maintained its intended meaning and psychometric properties when applied to a French–Canadian population and whether some items could be better formulated to meet the needs of people undergoing genetic counseling for HBOC. The cross-cultural adaptation and validation process generated a French version that is clearly understood by counselees and whose psychometric properties are in line with those reported by other validation studies, including the original validation (Berkenstadt et al., 1999; Cuturilo et al., 2016; McAllister et al., 2012; Smets et al., 2006). Indeed, we observed a Cronbach's alpha coefficient of 0.88 for the whole instrument, whereas the other studies obtained Cronbach's alpha coefficients ranging from 0.75 to 0.86 (Berkenstadt et al., 1999; Cuturilo et al., 2016; McAllister et al., 2012; Smets et al., 2006). We observed few missing items, suggesting that the PPC questionnaire is well accepted and understood by counselees. The PPC was also shown to have a good responsiveness, as it was expected that PPC scores would be higher in the post-counseling sample than in the pre-counseling sample. In addition, post-counseling PPC scores are significantly correlated with GCSS scores.
These results confirm that the French version of the PPC questionnaire is a relevant instrument and could be useful for measuring the outcomes of genetic counseling services. This study extends previous validation studies by demonstrating the responsiveness of the PPC to change across five different languages, cultures, and healthcare environments, providing further evidence that the PPC is a measurable outcome for the evaluation of genetic counseling services. It has been established that a high PPC enables patients to better cope with a medical threat and reduces their risk of psychological distress (Shiloh et al., 1997). Considering this evidence, an increase in PPC following genetic counseling suggests the attainment of genetic counseling objectives, particularly in supporting counselees' psychological adjustment, thereby ensuring the delivery of genetic counseling services that meet the highest quality standards.
It is important to note that the cognitive interviews, intended to ensure the adequacy of the French version proposed by the professional translators, led to small changes in the choice of terms for certain questionnaire items. Indeed, the presence of the term “problem” in four of the nine items caused discomfort among participants, as they did not consider the presence of a genetic variant to be a problem. The term “problem” had a pejorative connotation for participants, and they felt they were being blamed for something over which they had no control. Replacing the term “problem” with the more neutral term “situation” made it easier and more comfortable for participants to answer the questionnaire item. We believe that this change does not alter the nature of the questionnaire, since the term “situation” refers to the same thing as the original term “problem.” Rather, this change ensured that participants' interpretations were consistent with the intended meanings of the four questionnaire items and thus ensured excellent content validity.
In line with the Dutch validation of their cancer genetic counseling sample (Smets et al., 2006), PPC scores were not related to any sociodemographic or medical variables. However, this was not the case for the post-counseling sample, as counselees with children or a cancer history had significantly lower scores. In fact, further analyses showed that the change in pre- and post-counseling scores was significantly lower in counselees with a cancer history. Moreover, counselees with children were significantly less satisfied with the genetic counseling than counselees without children. Several hypotheses could be proposed to explain the observed group differences. First, the impact of genetic counseling on the perception of control over hereditary risk may be limited for counselees with previous history of cancer. This could be because their diagnosis may have already prompted them to seek more information about hereditary cancer risks and related consequences. Additionally, they may feel that there is little more they can do since the disease is already present (Ballatore et al., 2020). Another possibility that counselees with children may struggle to develop a high sense of control over the potential transmission of genetic to their offspring (O'Neill et al., 2015). It is important to highlight that, with a score of 24.3/30, our sample of counselees with children remained highly satisfied with the genetic counseling session.
As expected, PPC scores were significantly positively correlated with satisfaction on the genetic counseling. This result provides evidence of convergent validity of the PPC questionnaire because PPC scores correlated with score of the GCSS in the theoretically expected direction. An interesting finding was that counselees who already had a high PPC score prior to genetic counseling were significantly more satisfied with genetic counseling. Convergent validity could only be assessed for counselees who completed both the pre- and the post-counseling questionnaires (72%). The results of our analysis of non-participation in the post-counseling questionnaire showed no significant relationship between pre-counseling PPC scores, sex assigned at birth, gender, age, having children, education level, or cancer history.
One of our findings diverges from the original three-factor structure of the instrument proposed by Berkenstadt which were to reflect Averill's three dimensions of control: cognitive, decisional, and behavioral (Averill, 1973; Berkenstadt et al., 1999). However, our analysis of the psychometric properties indicated that the PPC questionnaire may function better as a one-dimensional instrument, since the three-factor structure could not be demonstrated in our study. This finding is supported by the validation of other translated versions (Cuturilo et al., 2016; McAllister et al., 2012; Smets et al., 2006). These results do not contradict Averill's tripartite typology of control, but rather suggest that in a genetic counseling context for HBOC, the concept of PPC should be evaluated as a whole rather than through of its three dimensions. Consequently, the French version of the PPC questionnaire should be used as a one-dimensional instrument, providing a single overall score.
4.1 Study strengths and limitations
An important strength of our study is the use of a rigorous cross-cultural adaptation process for the translation of the PPC questionnaire into French. By conducting cognitive interviews, we were able to discern that the term “problem” in certain questionnaire items was not well suited for the context of genetic consultations for HBOC in a French–Canadian population. Without these interviews, such discrepancies may have gone unnoticed, highlighting the importance of this step in ensuring the questionnaire's appropriateness for the target population.
A main limitation of this study is the relatively small sample of participants (99 pre-counseling and 72 post-counseling) used for psychometric validation, leading to restricted generalizability. The results obtained were validated only in the context of genetic counseling for HBOC and reflect only the counseling model investigated in this study. Additionally, our sample was predominantly women, with gender representation close to 100%. However, Berkenstadt did not find any gender differences when investigating PPC properties (Berkenstadt et al., 1999). The limited sample size also affected the statistical power of our analyses, especially when exploring dimensionality in the post-counseling sample. It is suggested that a minimum of 10 observations per variable is necessary to conduct an EFA (Comrey & Lee, 2013). While this requirement was met with the pre-counseling sample (n = 99), it was not achieved with the post-counseling sample (n = 72). Future research with larger and more diverse samples is warranted to confirm and extend our findings to other clinical genetics patients in French-speaking Canada. In particular, it would be important to evaluate the psychometric properties of this French version of the PPC questionnaire across various French-speaking populations. Further studies would also be useful to assess test–retest reliability and interpretability of the French PPC questionnaire.
4.2 Practice implications
To our knowledge, this is the first study to cross-culturally adapt and validate a French instrument for evaluating the concept of PPC in the context of genetic counseling. The French version of the PPC questionnaire showed good psychometric properties, indicating its suitability as a PROM in the evaluation of genetic services. Addressing patients' perceptions of control is essential for providing effective and patient-centered genetic counseling services. The French version of the PPC questionnaire is therefore a useful and validated instrument for assessing this outcome in a French–Canadian population of women from HBOC families. As the demand for genetic services increases and new delivery models are proposed, the integration of PROMs into genetic service evaluation is imperative to ensure that services remain patient-centered and efficient, as well as to identify areas for improvements.
5 CONCLUSIONS
The concept of PPC has a significant value in the context of genetic counseling, as a greater sense of control enables counselees to better cope with a medical threat and reduce their risk of psychological distress. This study has provided a French version of the PPC questionnaire that is well understood by counselees and has psychometric properties consistent with those reported in its other validated versions. Furthermore, it would be important to pursue the validation work for this questionnaire across other genetic counseling practice settings and delivery methods.
AUTHOR CONTRIBUTIONS
Conceptualization: Hermann Nabi; Methodology: Hermann Nabi, Michel Dorval, Julie Lapointe, Jocelyne Chiquette, Karine Bouchard, Sylvie Pelletier, Sophie Lauzier, Johanne Hébert; Validation: Camille Raîche, Julie Lapointe, Hermann Nabi; Formal analysis: Camille Raîche, Julie Lapointe; Investigation: Camille Raîche, Julie Lapointe; Resources: Hermann Nabi; Data curation: Camille Raîche, Julie Lapointe; Writing – original draft preparation: Camille Raîche, Julie Lapointe, Hermann Nabi; Writing – review and editing: Camille Raîche, Julie Lapointe, Célia Villafane-Bernier, Jocelyne Chiquette, Karine Bouchard, Sylvie Pelletier, Arian Omeranovic, Philippe Fortier, Claire Brousseau, Sophie Lauzier, Johanne Hébert, Michel Dorval, Hermann Nabi; Supervision: Hermann Nabi; Project administration: Julie Lapointe, Hermann Nabi; Funding Acquisition: Hermann Nabi.
ACKNOWLEDGMENTS
This research was conducted to fulfill a degree requirement. We would like to acknowledge the patients who generously contributed their time to participate in our study.
FUNDING INFORMATION
This research was funded by the Chaire de recherche en soins palliatifs of Université Laval and the Équipe de Recherche Michel-Sarrazin en Oncologie psychosociale et soins palliatifs (ERMOS). H.N. holds a senior research scholarship from the FRQ-S. Sophie Lauzier is a research scholar with funding from the Fonds de recherche du Québec-Santé (Québec Health Research Fund) in partnership with the Unité Soutien SRAP du Québec (#313085).
CONFLICT OF INTEREST STATEMENT
The authors declare no conflict of interest. Sophie Lauzier has received unrestricted research grants from Pfizer Canada and Eli Lilly for other studies not related to the one presented in this manuscript.
ETHICS STATEMENT
Human studies and informed consent: The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of CHU de Québec-Université Laval (protocol code 2020-4695 and 2023-6824). Informed consent was obtained from all participants for being included in the study.
Animal studies: No animal studies were carried out for this submission.
Open Research
DATA AVAILABILITY STATEMENT
The data that support the findings of this study are available from the corresponding author upon reasonable request.
