Cultural adaptation of the Italian version of the Patient-Reported Outcomes Common Terminology Criteria for Adverse Event (PRO-CTCAE®).

INTRODUCTION: US National Cancer Institute's (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) is a library of 78 symptom terms and 124 items enabling patient reporting of symptomatic adverse events in cancer trials. This multicenter study used mixed methods to develop an Italian language version of this widely accepted measure, and describe the content validity and reliability in a diverse sample of Italian-speaking patients. METHODS: All PRO-CTCAE items were translated in accordance with international guidelines. Subsequently, the content validity of the PRO-CTCAE-Italian was explored and iteratively refined through cognitive debriefing interviews. Participants (n=96; 52% male; median age 64 years; 26% older adults; 18% lower educational attainment) completed a PRO-CTCAE survey and participated in a semi-structured interview to determine if the translation captured the concepts of the original English language PRO-CTCAE, and to evaluate comprehension, clarity and ease of judgement. Test-retest reliability of the finalized measure was explored in a second sample (n=135). RESULTS: Four rounds of cognitive debriefing interviews were conducted. The majority of PRO-CTCAE symptom terms, attributes and associated response choices were well-understood, and respondents found the items easy to judge. To improve comprehension and clarity, the symptom terms for nausea and pain were rephrased and retested in subsequent interview rounds. Test-retest reliability was excellent for 41/49 items (84%); the median intraclass correlation coefficient was 0.83 (range 0.64-0.94). DISCUSSION: Results support the semantic, conceptual and pragmatic equivalence of PRO-CTCAE-Italian to the original English version, and provide preliminary descriptive evidence of content validity and reliability.

HIV priorities by Italian AIDS advocacy groups: information on prevention (still) comes first. An on-line survey.

OBJECTIVES: to define a list of priorities for activities and research projects based on the consultation of Italian AIDS advocacy groups through an online survey. DESIGN: a multidisciplinary advisory board was set up to define the survey and discuss the findings. Five areas - and related items - were listed: prevention, continuity of care, discrimination, research, key populations. Fifty-eight AIDS advocacy groups were identified and invited through e-mail to the survey, which lasted two months. Responders were asked to select a priority area and vote two items. Then, as second choice, they had to choose up to three items across the other areas. The final step of the prioritization process was the discussion of the survey findings with the advisory board. SETTING AND PARTICIPANTS: Italian HIV advocacy groups. RESULTS: thirty-seven groups responded (64%). The priority selected by most was prevention (around 80%), particularly preventive information addressed to teenagers and the general population. For the second choice, the most chosen items referred to discrimination and the continuity of care. The advisory board members underlined the need for a planned, organized, monitored, and evidence-based approach for HIV prevention information in different settings. CONCLUSIONS: different strategies to provide HIV prevention information should be proposed and monitored according to different targets, following an evidence-based approach. The stigma and discrimination against people with HIV and AIDS must be cleaned up to foster safe sex behaviours, providing education interventions at school. Wider structural issues have to be addressed, such as the availability and affordability of health services, contraceptive choices and condoms, poverty, and cultural gender norms.

Knowledge transfer: what drug information would specialist doctors need to support their clinical practice? Results of a survey and of three focus groups in Italy.

BACKGROUND: The wide offer of information on pharmaceuticals does not often fulfill physicians' needs: problems of relevance, access, quality and applicability are widely recognized, and doctors often rely on their own experience and expert opinions rather than on available evidence. A quali-quantitative research was carried out in Italy to provide an overview on information seeking behavior and information needs of doctors, in particular of infectious disease specialists, and to suggest an action plan for improving relevance, quality and usability of scientific information. METHODS: We did a quantitative survey and three focus groups. Two hundred infectious disease specialists answered a 24-item questionnaire aimed at investigating features of scientific information they receive and their ratings about its completeness, quality and usability. Subsequent focus groups, each involving eight specialists, investigated their opinions on information sources and materials, and their suggestions on how these could better support their information needs. RESULTS: The quantitative survey indicated doctors' appreciation of traditional channels (especially drug representatives) and information materials (brochures), but also their attitude to autonomous search of information and their wish to have more digital channels available. Focus groups provided more depth and, not surprisingly, revealed that physicians consider critical to get complete, comparative and specific information quickly, but also that they would like to discuss their doubts with expert colleagues. Quite strikingly, limited concerns were expressed on information validity, potential biases and conflicts of interests, as scientific validity seems to be related to the perceived authoritativeness of information sources rather than to the availability of a transparent evaluation framework. Although this research investigated views of infectious disease specialists, we believe that their opinions and perceived needs should not substantially differ from those of other clinicians, either in primary or in secondary care. CONCLUSIONS: In participants' view, the ideal information framework should provide quick and tailored answers through available evidence and favor the exchange of information between practitioners and trusted experts. The general consensus existing within the scientific and medical community on the need for integrating available evidence and experience is confirmed, although the issues of information validity and conflicts of interests seem definitely overlooked.