Some Principles of Forms Design

1.   General: Collect only information that you need to know.

2.   General: questions need to be clear and unambiguous.

3.   Layout should be consistent and logical.

4.   The intended format for answers should be clearly indicated.  It should not be necessary to refer to other documents for definitions.

5.   Print size should be readable by people with somewhat impaired vision.

6.   Esoteric or specialized terms, medical jargon and abbreviations, should be avoided.  For forms completed by patients rather than by staff, aim for a reading  level of 6th grade.

7.   The form should be self-coding whenever possible.

8.   Skip patterns should be clearly indicated.

9.   White space can help make a form more readable.  Crowding is bad.  Answer-boxes should be large enough to enter characters and numbers comfortably.

10.  Use consistent unambiguous formats for dates: e.g.,  05-APR-2009.

11.  Dates are often the most important data in a clinical trial.  Do not stint on collecting dates of key events, etc.

12.  If forms are translated into another language, get a 3rd party to translate them back into English to make sure the translation says the same thing as the original.

13.  NO ONE likes sense-marked forms.

14.  Computer-read forms have high error rates.

15.  Clearly indicate form number, version, and date of initiation.

16.  Print forms on NCR paper to generate copies automatically (if the original forms are to be mailed to the data center)

17.  Pilot-test forms with real patients.

18.  Self-completed forms must be particularly clear and well-laid-out.



Consent Forms for Clinical Trials

Consent forms present special issues and some of the constraints conflict with each other.  They need to:
 
1.   Clearly describe the objectives of the study

2.   Describe who is eligible and who is not.

3.   Describe the outcomes of interest.  

4.   Describe possible risks of the study interventions or procedures, honestly and in detail.  Quantify risk: e.g., ‘The risk of dying from this surgical procedure is less than 1/10 of 1%”.

5.   Describe what is expected of the participant in terms of clinic visits, contacts, diaries, tests, physical activities, diet, drug use, etc..

6.   Describe special risks associated with radiation exposure.

7.   Describe what specimens will be collected: blood, sputum, urine, etc..  Particularly describe collection of genetic specimens (DNA) and describe what tests will be done on them and how long they will be stored.

8.   Note that the participant’s confidentiality will be strictly protected.

9.   Note that the participant may withdraw consent at any time.

10.  Explain who has to pay if the participant is injured or made sick.

11.  Provide a place for the participant or his/her guardian to sign their name, along with similar space for a witness to sign.  

12.  Keep the reading level at a 6th grade or lower level.

13.  Offer to answer questions and help explain things that are not clear.

Do all this without making the form too long.  Some consent forms now are over 20 pages long.  There is a feeling that a short simple consent form which hits the high points but leaves out some of the detail may actually inform the participant better than a long complicated form.  Some people feel that participants should be tested to ascertain their level of understanding of the study.  If the participant cannot read, the consent form will need to be read to him/her.