Validation StudiesNCT01836107
Adaptation and Validation of a Score From English to Spanish for Evaluating Quality of Clinical Notes
An observational study of Validation Studies and Cross-Cultural Comparison, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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 The score is an instrument, originally made in English. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Validation Studies, Cross-Cultural Comparison, Medical Records
- How many people
- 38 participants
- Where
- 1 siteArgentina
- Study dates
- Apr 2013to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical notes (admission notes, progress notes and discharge summaries) will be included in the study following the original research.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Buenos Aires, Buenos Aires, C1181ACH
About this study
Official title: Cross-cultural Adaptation and Validation of a Score for Evaluating Quality of Inpatient Clinical Notes
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 The score is an instrument, originally made in English.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.
Read the 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.
- Keywords
- Clinical notes, Communication between physicians, Quality, Cross-cultural adaptation
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross cultural validity of a score
Evaluation of criterion validity (Gold Standard vs the use of the adapted score)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Validation StudiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Sonia E Benitez, MD, Principal investigator, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836107
- Sponsor's protocol ID
- 2027
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation and Validation of a Score for Evaluating Quality of Inpatient Clinical Notes
- ClinicalTrials.gov ID
- NCT01836107
- Acronym / sponsor ID
- 2027
- Keywords
- Clinical notes, Communication between physicians, Quality, Cross-cultural adaptation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical notes (admission notes, progress notes and discharge summaries) will be included in the study following the original research.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross cultural validity of a score
Time frame: 3 months
Evaluation of criterion validity (Gold Standard vs the use of the adapted score)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sonia E Benitez, MD principal investigator
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Validation Studies and Cross-Cultural Comparison, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross cultural validity of a score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2015.