Adaptation and Validation of a Score From English to Spanish for Evaluating Quality of Clinical Notes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01836107|
Recruitment Status : Completed
First Posted : April 19, 2013
Last Update Posted : March 24, 2015
The purpose of this study is to make a Spanish version of a score that evaluates the characteristics of a good quality clinical note for the purpose of physician communication. The score is an instrument, originally made in English. Due to the score will be used in a different country, language and culture of the original protocol, it is necessary apply a process of translation and adaptation to the context where the score is going to be applied.
The process of validation implies to evaluate if the instrument produces the same results under similar conditions and if the instrument maintains the ability to measure the same features or characteristics according to the original design.
|Condition or disease|
|Validation Studies Cross-Cultural Comparison Medical Records Total Quality Management|
Communication between health care providers is an important factor for the continuity of patient care. In the medical records, narrative components, such as clinical notes become important for this purpose. The inappropriate use of features , such as copy & paste, produces "unreadable" documents, with redundant information, reducing the quality of them. Within this framework, it is essential to assess the quality of clinical notes to implement mechanisms to improve it.
This study proposes to make a Spanish version of the Physician Documentation Quality Instrument (PDQI9) The original instrument evaluates the characteristics of a good quality clinical note for the purpose of physician communication. Due to a measuring instrument should be reliable and valid, not only for the original research population, and the score will be used in a different country, language and culture it is necessary a cross-cultural validation of the score.
The objective is to do a cross-cultural adaptation and validation of the Spanish version of "PDQI9" score, analyzing the use of PDQI-9 in a different language (Spanish), in an institution of different size (Hospital Italiano de Buenos Aires), with a different Electronic Health Record (EHR).
The process of cross-cultural validation involves two phases: the first phase is the translation and cross-cultural adaptation of the instrument. This phase will produce a Spanish version of the score and involves an expert panel of internal medicine physicians and a group of internal medicine physicians for the pilot evaluation.
The second phase evaluates the reliability and validity of the Spanish version. This phase includes internal consistency, intra-rater reliability, inter-rater reliability and the evaluation of the criterion validity of the adapted instrument. The validity of the adapted instrument will be measured comparing the score results with the Gold Standard represented by an expert committee. For every phase, the clinical notes (admission notes, progress notes and discharge summaries) will be randomly and stratified selected.
|Study Type :||Observational|
|Actual Enrollment :||38 participants|
|Official Title:||Cross-cultural Adaptation and Validation of a Score for Evaluating Quality of Inpatient Clinical Notes|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
- Cross cultural validity of a score [ Time Frame: 3 months ]Evaluation of criterion validity (Gold Standard vs the use of the adapted score)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836107
|Hospital Italiano de Buenos Aires|
|Buenos Aires, Argentina, C1181ACH|
|Principal Investigator:||Sonia E Benitez, MD||Hospital Italiano de Buenos Aires|