Time needed for data collection in clinical studies on fixed prosthodontics.
OBJECTIVE
Realistic appraisals of time and costs are crucial for research grants and financing of clinical studies by sponsors, but little is known about the time actually needed for clinical data collection in dental studies. This survey evaluated the net time of patient contact necessary for collection and documentation of clinical data to establish an empirical base for more efficient study management and budgeting.


METHODS
The time needed for the clinical examination of 41 prosthodontic patients in systematic follow-up was recorded. Examination covered dental status, oral hygiene status, and quality assessment of restorations by modified CDA criteria. Completion of the case report forms, data check, and provisions for data retrieval were also included. The recorded times were analyzed to obtain empirical estimates of the time actually needed for specific examination blocks and to detect potential variables of influence.


RESULTS
Predominant time records were 5 to 10 minutes for dental status (according to status complexity) or hygiene. The time needed for CDA ranking showed a linear correlation to the number of units, approximately 1 minute each. Documentation times were similar to the total contact times of all examination blocks, between 15 and 30 minutes per patient.


CONCLUSIONS
The overall time for collection and documentation of retrievable data is considerable (about 30 minutes, up to 1 hour). The data provide an empirical base for sound managing and budgeting of follow-up periods in clinical investigations, which is of major importance for the quality of clinical data, and thus for the success and value of clinical investigations.
Groten
Martin
M
Department of Prosthodontics, Dental Clinic, University of Tübingen, Germany. martin.groten@med.uni-tuebingen.de
Axmann
Detlef
D
D003442:Crowns; D003625:Data Collection; D003792:Dental Records; D018865:Dental Research; D003830:Denture, Partial, Fixed; D004282:Documentation; D005500:Follow-Up Studies; D005568:Forms and Records Control; D006801:Humans; D016247:Information Storage and Retrieval; D009909:Oral Health; D009910:Oral Hygiene; D010808:Physical Examination; D011785:Quality Assurance, Health Care; D013997:Time Factors; D013996:Time and Motion Studies