NETT consent statements are prototypes that NETT centers use when
developing their own consent statements.
Consent
for Screening and Patient Registry
This consent statement is to be signed at the start of the first
face-to-face visit at the NETT clinic. It introduces the concept
of the trial and registry and the screening process for both. It
also requests consent for diagnostic testing and pre-rehabilitation
assessments at the NETT clinic and consent for inclusion in the
registry.
Consent
for Pulmonary Rehabilitation
This statement is to be signed after the patient has completed the
diagnostic and pre-rehabilitation assessments and has been judged to
have emphysema of the degree under study in the NETT, to have none of
the exclusionary conditions that apply at this stage of screening, and
to have been judged eligible to enroll in the pulmonary rehabilitation
program required prior to assessment for randomization in NETT.
This consent commits the patient to participation in a 6-10 week program
of pulmonary rehabilitation and continued evaluation for enrollment in
the trial.
Consent
for Randomization
This statement is to be signed after the patient has completed 6-10
weeks of pulmonary rehabilitation, has completed the post-rehabilitation
assessments, and has been found to be eligible for randomization.
This consent should be given to the patient long before the patient is
asked to sign it, since signature of it represents a major commitment on
the part of the patient.
Additional language for
substudy consent
Clinics participating in one or more substudies had to include
additional language in their NETT consents to cover substudy activities.
Consent for clinic visit
in extension year (01Jan03 through 31Dec 03)
Consent for telephone visit in
extension year (01Jan03 through 31Dec03)
In Dec 2002, NETT followup was extended from the originally planned
end date of 31 Dec 2002 through 31 Dec 2002, but at a reduced visit
schedule. During 2003, only the 6 month, 2 year, 3 year and 5 year
visits were done in person. 1 year and 4 year visits were done by
telephone.
Consent for mailed
questionnaires in 2004
In Dec 2003, NETT followup was extended from the planned end date of
31 Dec 2003 to include one last mailing of the four quality of life
questionnaires collected in NETT. Each patient was asked by mail
to complete the questionnaires one last time between 01 Jan 2004 and 30
Jun 2004.
