Consequences of Screening in Breast Cancer (COS-BC): development of a questionnaire

Abstract

Objective

The aims of the study were to translate and adapt both the negative and positive items of the Psychological Consequences Questionnaire (PCQ) into Danish and to test the translated version for comprehension, suitability, and content coverage by developing new items in a setting of false-positive screening mammography.

Design

The translation was carried out following an internationally accepted method involving two panels: bilingual and lay.

Subjects

The suitability and the content coverage of the PCQ were tested in six group interviews. Participants in the interviews were women who had had a false-positive screening mammography. They were grouped according to additional examinations they experienced following abnormal screening mammography. The audio-recordings from the group interviews were thematically analysed to identify the key consequences of abnormal and false-positive screening mammography.

Results

Fifteen new items were generated to cover the negative psychosocial consequences of abnormal and false-positive screening mammography comprehensively. Five new items were produced that concerned the consequences of screening mammography during the period after being declared “free from” suspicion of cancer. Three items from the PCQ were deleted because they were judged by interviewees to be irrelevant. Response options for the positive items were changed to allow responses in both positive and negative directions.

Conclusion

Because of the major changes to both parts of the PCQ the measure derived from this study should be regarded as a new questionnaire with two parts: Consequences Of Screening in Breast Cancer (COS-BC). Part II focuses on the long-term consequences of a false-positive screening mammography.

No current questionnaire covers comprehensively all possible psychosocial consequences of abnormal and false-positive breast cancer screening results

• The Psychological Consequences Questionnaire includes ambiguous items and does not cover all psychosocial consequences of false-positive screening mammography.

• The women's experiences in the critical period from abnormal screening mammography until final false-positive diagnosis differed entirely from their experiences after the final diagnosis.

• A new comprehensive questionnaire COS-BC was developed to capture the psychosocial consequences of abnormal and false-positive screening mammography.

For each death prevented as a result of screening mammography approximately 200 women participating in the programme will experience a false-positive result [1]. Most of these women will experience negative psychosocial consequences that may last up to three years [2], [3]. Results of studies of the nature, extent, and duration of psychosocial consequences of false-positive screening mammography show discrepancies that can be partly explained by variations in the methods of measurement, specifically the use of questionnaires developed for other purposes [4].

The Psychological Consequences Questionnaire (PCQ) was developed to determine the negative and positive impacts of participating in screening mammography [5]. However, it has been used predominantly in the setting of false-positive screening mammography probably due to its quality [4] and higher sensitivity than other measures [6–8]. Therefore, it seemed to be an appropriate instrument for use in Denmark in a study of the consequences of abnormal and false-positive screening mammography. However, it was predicted that it would not be comprehensive in this setting as no women with a known false-positive screening mammography were interviewed during the development of the PCQ [4], [5].

The purpose of the study was threefold:

1. to translate and adapt the PCQ into Danish and test the translation for comprehension;

2. to test the suitability and especially the content coverage of the Danish version in a setting of false-positive screening mammography;

3. if necessary, to develop new items especially relevant in a setting of false-positive screening mammography.

Material and methods

The most frequently used part of the PCQ [3], [9] consists of 12 items covering negative aspects of participation in screening mammography. The other part, which has only been used in two studies [8], [10], consists of 10 items covering perceived positive aspects.

The translation was carried out following an internationally accepted method involving two panels [11]. The members of the first panel were bilingual in English/Danish with Danish as their mother tongue. None of the participants had a medical training. The members of the second panel were lay people. After having independently translated both parts of the PCQ members of the bilingual panel met with the authors of this article and discussed their translations until a consensus was reached. If consensus could not be reached, alternative translations of items or instructions were sent to the lay panel for consideration.

The members of the lay panel were asked to consider whether the items and the instructions produced by the bilingual panel were expressed in easily understood lay language. If not, they were required to suggest alternative wording. If the bilingual panel had suggested alternatives the lay panel members were encouraged to choose the option they preferred.

Following translation of the PCQ, group interviews were conducted with women who had been screened for breast cancer in the previous year and who had experienced an abnormal screening mammography later confirmed to be false-positive. The groups were made up of women who had received different types of intervention (ultrasound and clinical mammography, needle biopsy, surgical biopsy, early recall) following their abnormal screening mammography and whether or not they were screened opportunistically.

For each group invitations were posted to the first 20 women who met the entry criteria (intervention and location). All women who replied accepting the invitation were included in the study. For legal reasons it was not possible to send a reminder to those who did not respond to the invitation or to obtain demographic information about non-responders.

Both authors of this article participated as moderators in the group interviews.

The group interviews lasted approximately two hours and consisted of two parts. The first part was an open-ended discussion on the psychosocial consequences of abnormal and false-positive screening mammography. The conceptualization of “psychosocial consequences” was based on the bio-psycho-social model in which people are not regarded as passive [12], [13]. They are considered able to both interact with and influence the environment [14].

In the second part of the group interview the participants were asked to complete both parts of the Danish version of the PCQ and to comment on the wording of the items and the instructions and ease of completion. The first group of women completed the PCQ produced by the translation panels. In the subsequent groups the women completed a version of the questionnaire that included changes resulting from the previous group interviews.

Cognitive interviewing was carried out item by item and covered comprehension, content relevance, and content coverage [15], [16]. The group interviews were audio-recorded and after each interview the recording was independently audited by the two authors, who conducted thematic analyses to determine the key consequences of abnormal and false-positive screening mammography. In the subsequent group interviews the themes identified were discussed in details. Furthermore, the women's verbatim comments were used to define a construct, specifying a range of intensity from, for example, little to severe anxiety. Finally, results of the analyses were compared and if they did not correspond, the relevant sequences from the audio-recording were re-audited and discussed until consensus was reached.

The study was approved by the local ethical committee.

Results

Translation panels and group interviews

The first panel consisted of four female academics aged 31–37 years. The four members of the second (lay) panel were female state-school teachers aged 55–65 years. All of them taught Danish and none had ever taught English. Six group interviews were conducted with 34 women (aged 21–71; mean 57.3 years) with five to seven participants in each group. Of these, four groups were recruited from a mass screening programme and two from opportunistic screening.

The negative PCQ items

The translations of five of the 12 negative items of the PCQ were accepted by the lay panel without any changes. Four other items were changed into everyday language while retaining the meaning of the original items. Three items created problems because they each asked about two separate issues. Two of these items were each split into two new separate items. One of the descriptive words was deleted from the third item because of redundancy.

The bilingual panel suggested two different types of response options for the negative items. They argued that in Danish some of the items should more correctly be followed by options expressing “degree” rather than “frequency”. The changes in response options were accepted by the lay panel and the women participating in the interviews.

The women in the first group interview suggested changes in three items. Item 1, “having trouble sleeping”, was found to be too general. They wanted a more detailed description of their sleeping problems which resulted in three new items. The colloquial Australian wording of item 8, “taking things out on other people”, was adapted by the panels into colloquial Danish and the women in the first group interview suggested that the content of the item would be better covered by two separate items. A similar decision was taken for item 9.

To cover the negative psychosocial consequences of abnormal and false-positive screening mammography comprehensively 15 new items were generated following the analyses of the audio-recordings; 12 after the first group and one new item after each of the second, third, and fifth group. Some of the new items covered areas not included in the PCQ, i.e. breast examination, sexuality, and sick leave, while other new items extended the coverage of having experienced a false-positive screening result. In the subsequent group interviews the participants confirmed that the new items were relevant and suitable. To ensure that the content of the item suggested in the fifth group was relevant not only for participants of that particular group and the last group, the audio-recordings of the preceding four groups were re-audited. This process confirmed that the subject matter of the item generated in the fifth group was also raised in the preceding group interviews. In summary the negative items of the PCQ were increased from 12 to 33 items (Table I).

Table I.

The content of the negative items in the original Australian version of the PCQ and the Danish version.

The content of the original Australian PCQ	Content of the resulting Danish questionnaire (COS-BC part I)	The step where the change took place
1) Trouble sleeping	Taken me a long time to fall asleep	The first group interview
	Slept badly
	Taking sleeping tablets
2) Change in appetite	Change in appetite	No change
3) Unhappy or depressed	Unhappy	Translation panel
	Depressed
4) Scared and panicky	Scared	Translation panel
	Panicky
5) Nervous or strung up	Nervous	Lay panel
6) Under strain	Under strain	No change
7) Keeping things from those who are close to you	Keeping things from those who are close to you	No change
8) Taking things out on other people	Irritable	Translation panel
	Upset
9) Noticeable withdrawal from those who are close to you	Withdrawn into myself	Lay panel
	Quieter than normal
10) Difficulty doing normal things around the house	Difficulty doing normal things around the house	No change
11) Difficulty meeting work or other commitments	Difficulty meeting work or other commitments	No change
12) Worried about your future	Worried about my future	No change
Please note that in both versions the women were asked to indicate if they had been – had had – had felt – had found themselves or had experienced any of the following	Less attractive	The group interviews
	Worried
	Tired
	Busy taken mind off things
	Hard to concentrate
	Examined my breasts
	Restless
	Uneasy
	Examined my breasts in the mirror
	Unable to cope
	Symptoms from the breast (pins and needles)
	Headache
	Less interest in sex
	Not felt like having my breast caressed
	Sick leave

The positive PCQ items

A special topic raised and discussed by the women in the first group interview was that their experiences in the critical period from abnormal screening mammography until final false-positive diagnosis differed entirely from their experiences after the final diagnosis. In addition it was argued that some issues could only be raised after they had been declared “free from” suspicion of cancer. The participants classified the issues exclusively relevant to the period after final diagnosis as long-term psychosocial consequences of false-positive screening mammography. The women in the following five group interviews agreed with these arguments.

The participants in the first group interview pointed out that the contents of seven of the 10 positive PCQ items were suitable as long-term consequences and three items were irrelevant. One of the seven suitable items (item 3) contained two different questions and, again, had to be split into two by the lay panel. However, the resulting eight items were regarded as insufficient to cover the experiences they had had after final diagnosis and they suggested five more issues that should be covered. Five new items were generated and these were accepted in the following group interviews.

The participants also claimed that the consequences of the final diagnosis were not all positive. Compared with the time before participation in screening, the women argued that following final diagnosis there were negative as well as positive consequences.

The positive PCQ items allowed only for changes in a positive direction. Therefore, while retaining the meaning, the questions included in the seven items were re-phrased to allow for response options describing changes in both directions.

The women in the first group interview suggested three response categories; “less”, “the same as before”, and “more”. However, these were not found to be detailed enough by the members of the second group who suggested extending the numbers of response options to seven (“much less”, “less”, “a little less”, “the same as before”, “a little more”, “more”, and “much more”). These seven categories were presented to the participants in the subsequent four groups. They were accepted as relevant although some participants found them too differentiated. These participants remarked that it was difficult to differentiate between “a little less” and “less”, and between “a little more” and “more”. Conversely, it seemed that selecting “much less”, “much more”, or “the same as before” was easier. The changes from positive PCQ items into items measuring long-term psychosocial consequences are summarized in Table II.

Table II.

The original Australian positive items of the PCQ and the resulting Danish items.

The original positive items of the PCQ	The content of the resulting Danish items
1) A sense of reassurance that you do not have breast cancer	Belief that I do not have breast cancer
2) Feeling more relaxed	Feeling relaxed
3) Improved relationship with friends or relations	Relationship with friends
	Relationship with my family
4) Feeling more able to do things which I normally do	Irrelevant
5) Feeling more able to meet your home and/or work responsibilities	Irrelevant
6) Feeling more hopeful about the future	Thoughts about the future
7) Feeling less anxious about breast cancer	Anxiety about breast cancer
8) Getting on better with those around you	Relationship with other people
9) Been sleeping better	Irrelevant
10) A greater sense of well-being	Sense of well-being
Please note that in the original Australian versions the women were asked to indicate if they had been – had had – had felt – had found themselves or had experienced any of the following	Feeling calm*
	Enjoyment of life*
	Value life*
	Awareness of life*
	Thought about the broader aspects of life*

Note: *New items.

Discussion

None of the studies that have used the PCQ for measuring the psychosocial consequences of false-positive screening mammography have reported any pilot-testing in this setting [4]. The results of this study show the fundamental importance to the development and adaptation of questionnaires. The results illustrate the rigour to which clinicians and researchers must adhere when adapting a questionnaire intended for a somewhat different population and/or developed in another country. The results of the group interviews demonstrate the value of employing qualitative methods in questionnaire development [17], specifically for ensuring the content coverage [18].

Choosing to develop a new questionnaire from an existing one that has been applied in several studies has some advantages. It saves time and cost and may make it possible to compare results from one country to another. In the present study an ethical dilemma was avoided. It was not necessary to include women in the critical period – between abnormal screening mammography and final diagnosis of the absence of cancer – as women in such a situation had already been interviewed during the development of the PCQ. However, although deeply influenced by their former experiences all women participating in the group interviews discussed open-mindedly and willingly the thoughts and feelings they had had in the critical period.

A disadvantage of choosing to develop a new questionnaire from an existing one originally developed in another language is that it has to be translated. Several translation methodologies have been suggested [19]. One of these includes a forward–backward translation, which does not guarantee linguistic quality of the target version of the questionnaire [11], [20]. In this study, quality control of the target version was conducted in two steps: the lay panel and the group interviews.

It was revealed that the specific psychosocial consequences following the final screening diagnosis were not only positive. The positive PCQ items were generated mainly from interviews with women with normal screening results [5]. This may explain why the PCQ does not allow for both positive and negative long-term psychosocial consequences.

Of the 120 women invited to the six group interviews only 34 accepted. Those who did not respond to the invitation could have been demographically different from the participants and they could have experienced different or more severe psychosocial consequences. It was not possible to obtain information about the non-responders due to confidentiality and for other legal reasons. However, the fact that only three new items were generated in the second to the fifth interview indicates a high degree of data saturation. Furthermore, the third to fifth groups included 12 women who had undergone surgery and five on early recall, both regarded as the subgroups with the most severe negative experiences [2], [7].

Conclusion

To cover the psychosocial consequences of abnormal and false-positive screening mammography sufficiently it was necessary to significantly change some of the PCQ items, develop several new items, and change the response options substantially. Because of these major changes the measure derived from this study should be regarded as a new questionnaire with two parts: the Consequences Of Screening in Breast Cancer (COS-BC). Part II focuses on the long-term consequences of a false-positive screening mammography.

Implications for research

Data have been collected for statistical validation of the COS-BC including test of dimensionality, reliability, and tests to determine if the response categories function as intended. This has been finalized for part I [21] and is in progress for part II.