ComprehensionLISYCOMNCT00908557
Impact of Readability Improvements on the Comprehension of Written Information Given to Clinical Trial Patients: a RCT
A study testing readability improvement and good practice redaction in people with Comprehension, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in writing the Information and Consent Form (ICF) given to patients participating in clinical trials, increases their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comprehension
- What is being tested?
- readability improvement and good practice redaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Mar 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject considered suitable to participate in one of the clinical trials selected for the LISYCOM study
- Age > 18 years
Who cannot join
- Illiteracy or inability to read French
- Neurological deficiency making reading impossible (attention disorders, aphasy, etc)
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site
Clinical Research Center, University Hospital Grenoble
Grenoble, 38043
About this study
Official title: Multicenter RCT to Assess the Impact of Improvements in Lexico-syntactic Readability and Good Practice in Writing on the Comprehension of Written Information Given to Patients Participating in Clinical Trials.
The principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in writing the Information and Consent Form (ICF) given to patients participating in clinical trials, increases their understanding of the information compared to conventional written information, in real (not simulated) conditions.
Read the detailed description
The quality of written information given to people participating in clinical trials is essential as by law all volunteers have to be informed of a certain number of key elements. Those elements that are necessary to understanding and making a decision as to whether to participate in the trial are presented to the volunteer in the information and consent document (ICD).
Many terms used in the ICD are of necessity medical terms and sometimes difficult to understand for the person who may participate in the study.
Several factors are involved when a reader receives a text, and one of the difficulties of intelligibility can be the lexico-syntactic readability.
The lexico-syntactic readability is the only element of intelligibility that can be readily quantified, using the Flesch-Kincaid index. It is also an element that can be very easily modified without changing the sense of the information.
In the QuIP-3 study, which we performed in 2003, it appeared that the lexico-syntactic readability of ICF is very low, lower than that of texts used in university level classics examinations. Furthermore, there is no correlation between the density of information and readability (QuIP-5 study).
It seems to be necessary to assess the understanding of those participating in clinical trials in terms of logical and cognitive intelligibility (representativeness and interpretability of the information and consent forms). Indeed, a text may be unreadable according to the Flesch score, in lexico-syntactic terms, but perfectly understood and interpreted.
As no questionnaire had been validated in French, we validated the " Questionnaire d'Evaluation de la Compréhension de l'Information Ecrite par les Malades or QECIEM " (Questionnaire measuring patient comprehension of written information) (QuIP-4). This questionnaire can be used to measure both objective and subjective general understanding by a patient to be included in a therapeutic study, irrespective of the pathology.
- Conditions
- Comprehension
- Being tested
- readability improvement and good practice redaction, Control
- Keywords
- Lexicosyntactic readability improvement, phase II/III trials, ethic, Informed consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
readability improvement and good practice redactionOther
improvement using Flesch readability index and good practice in redaction of informed consent documents.
ControlOther
information based on the classic informed consent document
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients receiving an information and consent form that has been modified using the LISYCOM methods. Receives: Other: readability improvement and good practice redaction |
| 2 | Active comparator | Patients receiving a standard information and consent form. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.
Measured: 24 hours
Secondary outcomes (7)
Total score in the QECIEM questionnaire of comprehension.
Measured: 24 hours
Sub-scores in part B (subjective comprehension) of questionnaire of comprehension.
Measured: 24 hours
Adhesion to proposed clinical trial protocols
Measured: end of the study or end of Lisycom
Impact of complementary oral information on the QECIEM scores
Measured: 24 hours
Subjective evaluation of readability by the investigator
Measured: begin of the study or begin of Lisycom
Number of refusals to sign informed consent form for the proposed trial.
Measured: end of the study or end of Lisycom
Score of the QECIEMc
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ComprehensionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Research Center of Grenoble, Clinical Research Center of Strasbourg, Hôpital Necker-Enfants Malades, Clinical Research Center of Lyon, Clinical Research Center of Bichat, Paris, Clinical Research Center of Saint-Etienne, Clinical Research Center - biotherapy center of Saint-Louis, Paris, Clinical Research Center of Clermont-Ferrand, Clinical Research Center of Reunion island, Clinical Research Center - Biotherapy center of Nantes, CIC 1417 Cochin-Pasteur, Pharmacology unit of Créteil, Clinical Research Center, Toulouse
- Responsible party
- Principal investigator, AdministrateurCIC, University Hospital, Grenoble
- Investigators
- Jean-Luc CRACOWSKI, MD, Principal investigator, Clinical Research Center Grenoble France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00908557
- Sponsor's protocol ID
- DCIC 08 15
- Acronym
- LISYCOM
- Status last verified
- Sep 2014
- First submitted
- 26 May 2009
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Paris A, Cracowski JL, Ravanel N, Cornu C, Gueyffier F, Deygas B, Guillot K, Bosson JL, Hommel M. [Readability of informed consent forms for subjects participating in biomedical research: updating is required]. Presse Med. 2005 Jan 15;34(1):13-8. doi: 10.1016/s0755-4982(05)83877-1. French.
PubMed 15685092Paris A, Cracowski JL, Maison P, Radauceanu A, Cornu C, Hommel M. Impact of French 'Comites de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information. Fundam Clin Pharmacol. 2005 Jun;19(3):395-9. doi: 10.1111/j.1472-8206.2005.00327.x.
PubMed 15910664Okais C, Paris A, Cracowski JL. [Readability and information density in biomedical research]. Therapie. 2007 Jan-Feb;62(1):17-21. doi: 10.2515/therapie:2007008. Epub 2007 Mar 21. French.
PubMed 17374343Paris A, Cornu C, Auquier P, Maison P, Radauceanu A, Brandt C, Salvat-Melis M, Hommel M, Cracowski JL. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol. 2006 Feb;20(1):97-104. doi: 10.1111/j.1472-8206.2005.00391.x.
PubMed 16448400Paris A, Nogueira da Gama Chaves D, Cornu C, Maison P, Salvat-Melis M, Ribuot C, Brandt C, Bosson JL, Hommel M, Cracowski JL. Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study. Fundam Clin Pharmacol. 2007 Apr;21(2):207-14. doi: 10.1111/j.1472-8206.2007.00472.x.
PubMed 17391294
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter RCT to Assess the Impact of Improvements in Lexico-syntactic Readability and Good Practice in Writing on the Comprehension of Written Information Given to Patients Participating in Clinical Trials.
- ClinicalTrials.gov ID
- NCT00908557
- Acronym / sponsor ID
- LISYCOM / DCIC 08 15
- Conditions
- Comprehension
- Keywords
- Lexicosyntactic readability improvement, phase II/III trials, ethic, Informed consent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Research Center of Grenoble, Clinical Research Center of Strasbourg, Hôpital Necker-Enfants Malades, Clinical Research Center of Lyon, Clinical Research Center of Bichat, Paris, Clinical Research Center of Saint-Etienne, Clinical Research Center - biotherapy center of Saint-Louis, Paris, Clinical Research Center of Clermont-Ferrand, Clinical Research Center of Reunion island, Clinical Research Center - Biotherapy center of Nantes, CIC 1417 Cochin-Pasteur, Pharmacology unit of Créteil, Clinical Research Center, Toulouse
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 May 2009 (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 principle objective of this randomised controlled trial is to assess whether an improvement in lexico-syntactic readability combined with adherence to French recommendations for good practice in writing the Information and Consent Form (ICF) given to patients participating in clinical trials, increases their understanding of the information compared to conventional written information, in real (not simulated) conditions.
Detailed description
The quality of written information given to people participating in clinical trials is essential as by law all volunteers have to be informed of a certain number of key elements. Those elements that are necessary to understanding and making a decision as to whether to participate in the trial are presented to the volunteer in the information and consent document (ICD).
Many terms used in the ICD are of necessity medical terms and sometimes difficult to understand for the person who may participate in the study.
Several factors are involved when a reader receives a text, and one of the difficulties of intelligibility can be the lexico-syntactic readability.
The lexico-syntactic readability is the only element of intelligibility that can be readily quantified, using the Flesch-Kincaid index. It is also an element that can be very easily modified without changing the sense of the information.
In the QuIP-3 study, which we performed in 2003, it appeared that the lexico-syntactic readability of ICF is very low, lower than that of texts used in university level classics examinations. Furthermore, there is no correlation between the density of information and readability (QuIP-5 study).
It seems to be necessary to assess the understanding of those participating in clinical trials in terms of logical and cognitive intelligibility (representativeness and interpretability of the information and consent forms). Indeed, a text may be unreadable according to the Flesch score, in lexico-syntactic terms, but perfectly understood and interpreted.
As no questionnaire had been validated in French, we validated the " Questionnaire d'Evaluation de la Compréhension de l'Information Ecrite par les Malades or QECIEM " (Questionnaire measuring patient comprehension of written information) (QuIP-4). This questionnaire can be used to measure both objective and subjective general understanding by a patient to be included in a therapeutic study, irrespective of the pathology.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: readability improvement and good practice redactionPatients receiving an information and consent form that has been modified using the LISYCOM methods. |
| 2 | Active comparator | Other: ControlPatients receiving a standard information and consent form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject considered suitable to participate in one of the clinical trials selected for the LISYCOM study
- Age > 18 years
Key exclusion criteria (3 listed)
- Illiteracy or inability to read French
- Neurological deficiency making reading impossible (attention disorders, aphasy, etc)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| readability improvement and good practice redactionimprovement using Flesch readability index and good practice in redaction of informed consent documents. | Other | 1 |
| Controlinformation based on the classic informed consent document | Other | 2 |
Primary outcome
Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension.
Time frame: 24 hours
7 secondary outcomes
Total score in the QECIEM questionnaire of comprehension.
Time frame: 24 hours
Sub-scores in part B (subjective comprehension) of questionnaire of comprehension.
Time frame: 24 hours
Adhesion to proposed clinical trial protocols
Time frame: end of the study or end of Lisycom
Impact of complementary oral information on the QECIEM scores
Time frame: 24 hours
Subjective evaluation of readability by the investigator
Time frame: begin of the study or begin of Lisycom
Number of refusals to sign informed consent form for the proposed trial.
Time frame: end of the study or end of Lisycom
Score of the QECIEMc
Time frame: 1 year
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 12 Sep 2014.
- Background: PubMed 15685092Paris A, Cracowski JL, Ravanel N, Cornu C, Gueyffier F, Deygas B, Guillot K, Bosson JL, Hommel M. [Readability of informed consent forms for subjects participating in biomedical research: updating is required]. Presse Med. 2005 Jan 15;34(1):13-8. doi: 10.1016/s0755-4982(05)83877-1. French.
- Background: PubMed 15910664Paris A, Cracowski JL, Maison P, Radauceanu A, Cornu C, Hommel M. Impact of French 'Comites de Protection des Personnes' on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information. Fundam Clin Pharmacol. 2005 Jun;19(3):395-9. doi: 10.1111/j.1472-8206.2005.00327.x.
- Background: PubMed 17374343Okais C, Paris A, Cracowski JL. [Readability and information density in biomedical research]. Therapie. 2007 Jan-Feb;62(1):17-21. doi: 10.2515/therapie:2007008. Epub 2007 Mar 21. French.
- Background: PubMed 16448400Paris A, Cornu C, Auquier P, Maison P, Radauceanu A, Brandt C, Salvat-Melis M, Hommel M, Cracowski JL. French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research. Fundam Clin Pharmacol. 2006 Feb;20(1):97-104. doi: 10.1111/j.1472-8206.2005.00391.x.
- Background: PubMed 17391294Paris A, Nogueira da Gama Chaves D, Cornu C, Maison P, Salvat-Melis M, Ribuot C, Brandt C, Bosson JL, Hommel M, Cracowski JL. Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study. Fundam Clin Pharmacol. 2007 Apr;21(2):207-14. doi: 10.1111/j.1472-8206.2007.00472.x.
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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.
Jean-Luc CRACOWSKI, MD principal investigator
Clinical Research Center Grenoble France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing readability improvement and good practice redaction in people with Comprehension, run by University Hospital, Grenoble at 1 site in France.
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 2 inclusion and 3 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 12 Sep 2014. 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 France. 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?
Sub-score in part A (objective comprehension) of the QECIEM questionnaire of comprehension. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00908557, which also lists 5 linked publications.
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 12 Sep 2014.