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Validating a Measure to Delineate the Clinical Trials Nursing Role in Italy

Catania, Gianluca RN; Poirè, Ilaria RN; Dozin, Beatrice PhD; Bernardi, Matteo RN; Boni, Luca MD

doi: 10.1097/01.NCC.0000305761.11980.cc
Articles

In Italy, the role of a nurse in cancer research is beginning to develop, but instruments developed to delineate the dimensions of the Italian clinical trials nursing role are lacking. This study aimed to translate into Italian the Clinical Trials Nursing Questionnaire (CTNQ) and assess its content validity, internal consistency, and stability reliability. Forward-backward translation and review by experts were performed to assess linguistic and content validation. Internal consistency reliability was computed using Cronbach α and by administering the translated CTNQ to a sample of 30 research nurses coming from different Italian districts. To determine the test-retest reliability, a copy of the questionnaire was given again to a subgroup of 10 research nurses. The pretest and posttest scores were compared using κ coefficient. The comparison of the target language version with the original version allowed us to consider the translation of CTNQ as acceptable. The analyses revealed a Cronbach α coefficient of .98 for the frequency scale and .96 for the importance scale. The overall κ coefficient was 0.98 for the frequency scale and 0.99 for the importance scale. The CTNQ is a valid and reliable instrument for the assessment of the research nurse's role in Italy.

In Italy, the role of a nurse in cancer research is beginning to develop, but instruments developed to delineate the dimensions of the Italian clinical trials nursing role are lacking. This study aimed to translate into Italian the Clinical Trials Nursing Questionnaire (CTNQ) and assess its content validity, internal consistency, and stability reliability. Forward-backward translation and review by experts were performed to assess linguistic and content validation. Internal consistency reliability was computed using Cronbach α and by administering the translated CTNQ to a sample of 30 research nurses coming from different Italian districts. To determine the test-retest reliability, a copy of the questionnaire was given again to a subgroup of 10 research nurses. The pretest and posttest scores were compared using κ coefficient. The comparison of the target language version with the original version allowed us to consider the translation of CTNQ as acceptable. The analyses revealed a Cronbach α coefficient of .98 for the frequency scale and .96 for the importance scale. The overall κ coefficient was 0.98 for the frequency scale and 0.99 for the importance scale. The CTNQ is a valid and reliable instrument for the assessment of the research nurse's role in Italy.

Authors' Affiliations: S.S.I. Clinical Trials (Mr Catania and Dr Boni); S.S. Prevenzione Secondaria e Screening (Ms Poirè); S.C. Clinical Epidemiology, Istituto Nazionale per la Ricerca sul Cancro, Genova (Dr Dozin); and Oncoematologia Pediatrica, II° Clinica di Pediatria dell'Azienda Ospedaliera diPadova, Padova, Italy (Mr Bernardi).

Corresponding author: Gianluca Catania, RN, S.S.I. Clinical Trials, Istituto Nazionale per la Ricerca sul Cancro, Largo Rosanna Benzi, 10, 16132 Genova, Italy (gianluca.catania@istge.it).

Accepted for publication January 7, 2008.

© 2008 Lippincott Williams & Wilkins, Inc.