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Quality assurance for the EORTC 22071-26071 study: dummy run prospective analysis.

ABSTRACT: PURPOSE:The phase III 22071-26071 trial was designed to evaluate the addition of panitumumab to adjuvant chemotherapy plus intensity modulated radiotherapy (IMRT) in locally advanced resected squamous cell head and neck cancer. We report the results of the dummy run (DR) performed to detect deviations from protocol guidelines. METHODS AND MATERIALS:DR datasets consisting of target volumes, organs at risk (OAR) and treatment plans were digitally uploaded, then compared with reference contours and protocol guidelines by six central reviewers. Summary statistics and analyses of potential correlations between delineations and plan characteristics were performed. RESULTS:Of 23 datasets, 20 (87.0%) GTVs were evaluated as acceptable/borderline, along with 13 (56.5%) CTVs and 10 (43.5%) PTVs. All PTV dose requirements were met by 73.9% of cases. Dose constraints were met for 65.2-100% of mandatory OARs. Statistically significant correlations were observed between the subjective acceptability of contours and the ability to meet dose constraints for all OARs (p???0.01) except for the parotids and spinal cord. Ipsilateral parotid doses correlated significantly with CTV and PTV volumes (p???0.05). CONCLUSIONS:The observed wide variations in treatment planning, despite strict guidelines, confirms the complexity of development and quality assurance of IMRT-based multicentre studies for head and neck cancer.

SUBMITTER: Fairchild A

PROVIDER: S-EPMC4311463 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Quality assurance for the EORTC 22071-26071 study: dummy run prospective analysis.

Fairchild Alysa A Langendijk Johannes A JA Nuyts Sandra S Scrase Christopher C Tomsej Milan M Schuring Danny D Gulyban Akos A Ghosh Sunita S Weber Damien C DC Budach Wilfried W

Radiation oncology (London, England) 20141126

<h4>Purpose</h4>The phase III 22071-26071 trial was designed to evaluate the addition of panitumumab to adjuvant chemotherapy plus intensity modulated radiotherapy (IMRT) in locally advanced resected squamous cell head and neck cancer. We report the results of the dummy run (DR) performed to detect deviations from protocol guidelines.<h4>Methods and materials</h4>DR datasets consisting of target volumes, organs at risk (OAR) and treatment plans were digitally uploaded, then compared with referen ...[more]

PMID: 25424399

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Project description:BACKGROUND:Given the high cure-rate for testicular cancer (TC) and the patients' young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module. METHODS:This international, multicentre phase IV validation study enrolled testicular cancer patients from seven European countries. Patients completed the EORTC quality of life core questionnaire EORTC QLQ-C30 and the QLQ-TC26 at two consecutive time points and a debriefing questionnaire regarding the QLQ-TC26 after baseline assessment. Psychometric evaluation included examination of the hypothesized module scale structure, internal consistency and test-retest reliability, known-groups validity, responsiveness to change over time and cross-cultural acceptability. RESULTS:Data from 313 patients (mean age 38.6, SD 9.5) were analysed. All items exhibited a high completion rate with less than 2.4% missing values except for the sexuality items (up to 8.8%). The confirmatory factor analysis supported the hypothesised scale structure of the QLQ-TC26. Test-retest reliability was good for 8 of 12 scales (intraclass correlation: R t1|t2 ranged from 0.71-0.91) and four scales did not meet the acceptable criteria. Internal consistency was good for all twelve scales (Cronbach alpha?=?0.79-0.90), except Communication (alpha?=?0.67) and Sexual Functioning (alpha?=?0.62). The module was able to distinguish clearly between patients with differing clinical status. Responsiveness to change over time was acceptable. CONCLUSION:The EORTC QLQ-TC26 is a valid, reliable and well-accepted condition-specific questionnaire, supplementing the EORTC QLQ-C30, for the assessment of testicular cancer patients' HRQOL in clinical trials.

Project description:IntroductionCataract surgery is a relatively safe procedure with satisfactory postoperative results in most patients. However, in rare cases severe complications can occur shortly after the intervention. Therefore, patients are advised to undergo an ophthalmological examination postoperatively, which should be performed as soon as possible in case of emergencies. However, exactly when these follow-up visits should take place is still discussed. A time- and cost-saving alternative to this could be short-term postoperative telemedical approaches. The aim of this study was to analyze patient complaints as well as satisfaction with and the best timepoint to perform telephone calls after cataract surgery.MethodsPatients scheduled for cataract surgery received a telephone call on the surgery day or the day after (study group) during which they were asked about complaints or additional examination visits. Patients without telephone calls served as control group. All patients had a follow-up visit one week after the intervention during which a questionnaire was filled out and the study group was asked about their satisfaction with the telephone calls.Results181 patients were recruited in this study. Ocular surface problems were the most common postoperative symptom. More than 80% of the patients were very satisfied with the telephone calls, with patients being contacted on the day of surgery being more calmed than those called on the next day. No difference in additional and planned follow-up visits was found between the study and the control group (P > .40). Postoperative patient complaints (Phi 0.372, P < .001) and additional prescribed therapy (Phi 0.480, P < .001) were moderately associated with additional visits.ConclusionSatisfaction with telephone reviews shortly after cataract surgery was very high and contacting patients on the evening of the day of the procedure could be a time- and cost-saving alternative to short-term in-house follow-up visits.

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Quality assurance for the EORTC 22071-26071 study: dummy run prospective analysis.

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Quality assurance for the EORTC 22071-26071 study: dummy run prospective analysis.

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