A total of 49 questions underwent cross-cultural adaptation (see additional file 1: QPL final version following patient evaluation). All five stages were carried out in strict adherence to the indications of the literature . Concerning Stage II and III of the process, few discrepancies between the two back translations and the original version of the instrument were noted, indicating that T12 (synthesis of the 2 forward translations) was substantially accurate.
In stage IV, the directness of the language used in the Australian QPL, typical of English-speaking cultures, proved to be the major source of debate among the Committee. In some cases, items were slightly rephrased to make them less direct, still ensuring to maintain the original meaning. A faithful translation of the expression "so you have cancer..." was unanimously considered unacceptable for Italian users, and therefore was removed from the Italian version. The Committee also agreed not to use the Italian counterpart for "cancer", which carries a strong connotation of malignancy, although some Italian experts now feel the word should be used with patients. The milder term "tumor" was preferred, or in some cases, "cancer" was translated with the phrase "my illness", as this expression is often used by Italian-speaking oncology patients referring to their disease. In other instances, terms judged to be particularly harsh were maintained, as not to impact on the meaning, e.g. the expression "cancer survivor", which may sound somewhat disturbing to some Italian patients.
Other points of discussion within the Committee concerned the choice of technical vs. more colloquial terms. Generally, it was decided to keep the language informal and simple, following the English version, although in some cases the wording was slightly modified to better suit the Italian style.
A few idiomatic expressions proved problematic: in particular, the heading "Optimal care" was challenging for the forward translators, consequently causing the back translations of the phrase to be incongruent with the original version. The Committee finally agreed on a somewhat free translation of the heading: "Ensuring the best possible care".
The original QPL contained a few English words that are also used in Italian "checklist, follow-up, team". The Committee however chose to replace them with Italian terms, as they may not be known by all possible users.
From a grammatical point of view, the Committee took care to leave open questions open, although in some instances a closed question would have sounded better to Italian ears.
30 patients participated in the evaluation of the items, completing Stage V of the cross-cultural adaptation process. 60% of the sample was female, median age was 60 years; level of education was as follows: 13% primary school, 20% secondary school, 60% highschool, and 7% University graduate. Patient ratings of each item concerning the four dimensions of adequacy of content, clarity of wording, usefulness, and level of anxiety, expressed on a 3-point Likert scale, are depicted in Figures 1, 2, 3, and 4, respectively. For each dimension, three histograms were constructed, relative to the three scores: low, medium, and high. In each histogram, the X-axis depicts the 49 questions, and the Y-axis shows the frequency of the score expressed as percentages. To facilitate interpretation, the eleven domains, into which the questions were subdivided in the booklet, are highlighted.
Most questions received high scores (> 90%) for adequacy of content and clarity of wording (Figures 1 and 2). Ratings for clarity were slightly lower (< 70%) only for questions 19, 21, 22, 36, and 37 (see additional file 1: QPL final version following patient evaluation). Concerning usefulness, results were less uniform (Figure 3). Scores were particularly high for most questions in the "prognosis", "treatment information and options" and "preparing for treatment" domains. A few items received low scores: questions 20, 21, 22, 25, 35 (see additional file 1: QPL final version following patient evaluation). What these questions have in common is that they investigate factors external to the patient-physician relationship and not referring to the patient condition (second opinion, the multidisciplinary team, public vs. private institutions).
The level of anxiety generated by questions was judged low for most items (Figure 4). Only for the domains of diagnosis and prognosis, most questions received high scores (> 50% of patients).
The evaluation sheet also provided space next to each item where respondents could leave comments, which would be useful to identify frequent problems or observations. Comments were provided by 9 out of 30 subjects, and were most frequent in the "Optimal Care" and "The Multidisciplinary Team" domains. In particular, 5 patients indicated that they did not know the meaning of the terms "guidelines" and "multidisciplinary team".
Based on the abovementioned findings, the Committee decided to revise the prefinal version, rephrasing questions 19, 21, 22, 36 and 37 in order to improve clarity.
Questions 20 and 25, regarding seeking a second opinion and the relationship to multiple members of a team, were not removed, despite their low usefulness scores, as the group considered these to be crucial issues requiring special attention in the Italian culture. Similarly, question 35, concerning care in the public vs. private sectors, was not deleted despite its low usefulness scores. In fact, although differences between public and private institutions are not so evident in Italy, the question would be relevant to Italian speaking patients living in other countries.