| |
Quality control
techniques to be used in this study include:
- Using clear
definitions of pain;
- Staff training
sessions on how to collect data and encourage patient compliance;
and
- Making
extra measures to insure that patients are filling out the dairies
daily.
Data from
all the centers should be evaluated at the beginning of each chemotherapy
cycle to insure consistency in data collection from patient diaries
and that patients are being weighed. This study relies heavily
on patient cooperation in filling out their daily logs. Emphasizing
the need for patients to fill the log every day will be crucial.
The following
are important steps in obtaining high-quality data in a mucositis
related study:
- Have a
solid protocol design and investigator's manual;
- Clearly
define all key words;
- Train all
investigators and evaluators in assessment of pain and mucositis,
in use of the VAS scale, and in how to instruct patients on
study procedures and the diary;
- Regularly
monitor raw data to insure that entries are complete and correct;
- Review
mucositis assessments weekly to determine whether the mucositis
grades between the 2 scales, WHO and OMAS, are consistent. (For
instance, an OMAS ulceration grade of 1 or above must mean a
WHO grade of at least a 2. If mucositis grades are inconsistent,
the data are unreliable.); and
- Make corrections
and clarifications immediately.
If the study
involves multiple sites, special attention must be given to staff
training. A formal training session, preferably by the same instructor,
should be given at each site. Evaluators should be calibrated
to allow for accurate inter-rater reliability. In addition, mucositis
assessments should be performed at around the same time of day,
with proper lighting of the same type at each site, and the number
of evaluators should be limited to minimize error between raters.
|