Clinical trial NCT01836107: Adaptation and Validation of a Score From English to Spanish for Evaluating Quality of Clinical Notes
Official title: Cross-cultural Adaptation and Validation of a Score for Evaluating Quality of Inpatient Clinical Notes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validation Studies
Cross-Cultural Comparison
Medical Records
Total Quality Management
Keywords: Clinical notes
Communication between physicians
Quality
Cross-cultural adaptation
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 38
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical notes (admission notes, progress notes and discharge summaries) will be included in the study following the original research.

Brief summary: 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 The score is an instrument, originally made in English.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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* For every phase, the clinical notes will be randomly and stratified selected. The clinical notes must belong to patients hospitalized at Internal Medicine area in Hospital Italiano de Buenos Aires (HIBA) without any referral to or from other medical areas. The length of stay expected should be at least three days, and the Electronic Health Record (EHR) has to contain the admission notes, progress notes and discharge summaries.

Primary outcomes:
measure: Cross cultural validity of a score
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Sonia E Benitez, MD
role: PRINCIPAL_INVESTIGATOR
References: