Page 25 - Ovarian Cancer Surgery - Quality Indicators

5.4 QI 4 - Center participating in clinical trials in gynecologic oncology

5.4.1 Description of the QI

TYPE Structural indicator.
DESCRIPTION The center actively accrues patients in clinical trials in gynecologic oncology.

SPECIFICATIONS Numerator: not applicable.
Denominator: not applicable.

TARGETS Not applicable.

SCORING RULE 3 if the center actively accrues patients in clinical trials in gynecologic oncology

5.4.2 Rationale

Institutions participating in clinical research contribute to improve quality of care. Patients treated in study
hospitals have a higher chance of receiving standard treatment compared to patients treated in hospitals not
participating in cooperative clinical studies211. Furthermore, study centers do not only recruit patients but tend to
have infractructures associated with clinical trials participation. They have physicians interested in ovarian
cancer and motivated to perform studies. They also might participate more often in quality assurance programs.
The benefit could not be limited to patients enrolled in active protocols. The positive effects could also be
observed in patients where no protocol has been active211. Thus, patients treated in these centers but who are not
enrolled in clinical trials might receive quality of care above average as well. Finally, two previous initiatives26,53
published a QI for this topic.

5.4.3 Summary of available scientific evidence LoE 2-

Impact of participation in clinical studies on survival: as part of this national German survey, du
Bois et al.211 reported that non-participation in clinical studies was independently associated with an
82% increase of risk of death HR = 1.82, 95% CI = 1.27 -2.61, p = 0.001 after ajustment for stage,
performance status, ascites, comorbidity, age, histology, grading and hospital volume. Survival
advantages observed in this survey cannot be attributed to patients enrolled in study protocols
authors compared all patients treated in institutions participating in trials versus all patients treated
in institutions that do not participate.

Another study249 determined the effect of participation in clinical trials on survival. The on-study
subjects were similar to off-study subjects for age, ethnicity, residence location, stage, histology,
proportion of optimally debulked or completely staged surgically, proportion of patients receiving
recommended treatment. The authors reported that median OS was significantly superior in on-study
subjects 46 vs. 25 months, p = 0.03. A nonsignificant trend toward improved median PFS was also
observed in on-study patients 23 vs. 9 months, p = 0.087 .

Impact of participation in clinical studies on surgical outcome: as part of the national German LoE 2-
survey mentioned above, authors211,250 observed also that debulking performed in hospitals
participating in clinical studies were significantly more optimal residual tumour < 1 cm as
compared to those performed in centers do not participate OR = 1.63, 95% CI = 1.05 -2.53, p =
0.030 univariate analysis.

 OVARIAN CANCER SURGERY - QUALITY INDICATORS 
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