Radiotherapy and Oncology xxx (2014) xxx–xxx
Contents lists available at ScienceDirect
Radiotherapy and Oncology journal homepage: www.thegreenjournal.com
Original article
Does a central review platform improve the quality of radiotherapy for rectal cancer? Results of a national quality assurance project Ines Joye a,b, Maarten Lambrecht a,b, David Jegou c, Eszter Hortobágyi a,b, Pierre Scalliet d, Karin Haustermans a,b,⇑ a Department of Radiation Oncology, Leuven Cancer Institute, University Hospitals Leuven; b Department of Oncology, KU Leuven; c Department of Research, Belgian Cancer Registry, Brussels; and d Department of Radiation Oncology, Université Catholique de Louvain, Brussels, Belgium
a r t i c l e
i n f o
Article history: Received 15 November 2013 Received in revised form 12 February 2014 Accepted 4 March 2014 Available online xxxx Keywords: Rectal cancer Radiotherapy Target delineation Central review Quality assurance
a b s t r a c t Background and purpose: Quality assurance (QA) for radiation treatment has become a priority since poorly delivered radiotherapy can negatively influence patient outcome. Within a national project we evaluated the feasibility of a central review platform and its role in improving uniformity of clinical target volume (CTV) delineation in daily practice. Material and methods: All Belgian radiotherapy departments were invited to participate and were asked to upload CTVs for rectal cancer treatment onto a secured server. These were centrally reviewed and feedback was given per e-mail. For each five consecutive patients per centre, the overlap parameter dice coefficient (DC) and the volumetric parameters volumetric ratio (RV) and commonly contoured volume (VCC) were calculated. Results: Twenty departments submitted 1224 eligible cases of which 909 were modified (74.3%). There was a significant increase in RV and VCC between the first ten patients per centre and the others. This was not seen for DC. Statistical analysis did not show a further significant improvement in delineation over the entire review period. Conclusion: Central review was feasible and increased the uniformity in CTV delineation in the first ten rectal cancer patients per centre. The observations in this study can be used to optimize future QA initiatives. Ó 2014 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology xxx (2014) xxx–xxx
Colorectal cancer is the third most common cancer and accounts for the third most common cause of cancer-related death in the developed world [1]. Advances in screening, diagnosis and treatment have contributed to a better local control and an improved survival of rectal cancer over the past ten years. In order to maintain and further optimize outcome for rectal cancer patients, continuous focus on quality assurance (QA) and collective efforts of the multidisciplinary team members are mandatory. In this respect, training, centre’s experience and the quality of total mesorectal excision have proven to be important prognostic factors [2,3]. Furthermore, pathological feedback to surgeons has shown to be a powerful incentive to improve the resection quality [4,5]. Aside from surgery, radiotherapy is regarded as one of the cornerstones in the locoregional treatment of rectal cancer. Despite this crucial role, large multicentre trials have documented wide variations in the quality of radiotherapy [6–9]. Deviations in the ⇑ Corresponding author at: Leuven Cancer Institute, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium. E-mail address: [email protected] (K. Haustermans).
radiotherapy quality not only affect the validity of study results, they also might negatively influence outcome. Prospective quality control of radiotherapy equipment, treatment plans, dosimetric data and target volumes is therefore mandated. The importance of maintaining a uniform high treatment quality in the management of rectal cancer, has led to the launch of the Belgian initiative PROCARE (PROject on CAncer of the REctum) in 2006. The main objective of PROCARE, a voluntary multidisciplinary project, is to reduce diagnostic and therapeutic variability and thus improve outcome in rectal cancer patients treated in Belgium. Guidelines and quality indicators related to rectal cancer management have been developed by a multidisciplinary working group. Decentralized implementation of these guidelines, prospective registration of detailed patient data, feedback and benchmarking are keystones of this QA project. In an attempt to standardize radiotherapy for rectal cancer treatment, the PROCARE initiative set up a central review platform for clinical target volume (CTV) delineation. In this study we aimed to evaluate the feasibility of a central review platform and its value
http://dx.doi.org/10.1016/j.radonc.2014.03.003 0167-8140/Ó 2014 Elsevier Ireland Ltd. All rights reserved.
Please cite this article in press as: Joye I et al. Does a central review platform improve the quality of radiotherapy for rectal cancer? Results of a national quality assurance project. Radiother Oncol (2014), http://dx.doi.org/10.1016/j.radonc.2014.03.003
2
Impact of central review on CTV delineation
in improving uniformity of target volume delineation in daily practice. Material and methods
rections was left at the discretion of the treating physician. Feedback on which CTV was finally used for treatment planning was requested and classified as fully accepted, partly accepted, rejected or feedback missing. All data were archived at the Belgian Cancer Registry.
Study design In November 2009 a central review facility was established at the radiotherapy department of the University Hospitals Leuven (UHL) and of the Université Catholique de Louvain (UCL). Dedicated software (AquilabÒ, France) was used to set up a secured network between the review facilities and each participating radiotherapy department (Suppl. Fig. 1). All 25 radiation oncology departments in Belgium were invited to join this QA project. Centres were asked to delineate the CTV of each rectal cancer patient who was going to be irradiated. Delineation tools were distributed to all centres: the Belgian Healthcare Knowledge Centre guidelines on rectal cancer, internationally peer-reviewed CTV delineation guidelines, and a CTV delineation atlas, which had been discussed at a meeting of radiation oncologists from all Belgian radiotherapy departments [10,11]. The simulation protocol (contrast acquisition, patient positioning, slice thickness. . .) was left at the discretion of the participating centres. The submitted CTVs (CTVsub) were uploaded on a secured server. For each case a minimum of clinical information was required (age, gender, tumour localization, and cTNM staging). Review procedure A radiation technologist was trained in CTV delineation and reviewed all cases according to the guidelines at the UHL (Fig. 1) [11]. The first 50 delineations were reviewed under direct supervision of a senior radiation oncologist specialized in digestive oncology. This double-check procedure was repeated for every following 20th case. A radiologist was consulted if there were uncertainties about anatomical borders. Contourings of UHL patients were checked by a senior radiation oncologist of the UCL. The delineations were reviewed within 24 h and, if necessary, the modified CTV (CTVmod) was sent back to the original centre. Modifications were explained by e-mail. Acceptance or rejection of the proposed delineation cor-
Study population In March 2010 the review started with three centres, in May 2010 10 centres participated and in July 2011 there was a full operation between 20 centres. Between March 2010 and September 2012, 20 centres submitted 1255 rectal cancer cases. Since the manuscript of Roels et al. does not provide guidelines on delineation of the inguinal lymph nodes, cases in which inguinal irradiation was suggested (n = 6) were excluded [11]. Review was lacking in 25 cases. A total of 1224 rectal cancer cases were analysed.
Delineation agreement analysis For each patient the overlap parameter dice coefficient (DC) and volumetric parameters volumetric ratio (RV) and commonly contoured volume (VCC) were calculated. DC represents the ratio between the overlapping volume and the encompassing volume with the numerator multiplied by two. RV is the ratio between the CTVsub and CTVmod volume and VCC represents the percentage of the CTVmod which is irradiated (Suppl. Fig. 2). For all centres combined, we investigated whether the agreement improved over time after entry into the project. In order to account for the variability in the time of inclusion between two patients in one centre and between centres, we used a ranking system in which each five
Table 1 Patient demographics (n = 1224). Number (%) Gender Male Female
828 (68) 396 (32)
Mean (SD) Range (min–max) Missing
65.7 (11.1) 23.3–91.6 29
High Mid Low
232 (19) 390 (32) 602 (49)
Age
Tumour location
Tumour classification T1 T2 T3 T4 Tx Lymph node classification N0 N1 N2 Nx Metastasis classification M0 M1 Mx cTNM stage I II III IV Xa Fig. 1. Example of a submitted case with modification. The submitted CTV is depicted by a solid line, the suggested modifications are represented by a dashed line. In this case, the external iliac vessels were excluded because the patient had a high-seated tumour without invasion of the anterior organs.
6 (1) 122 (10) 970 (79) 110 (9) 16 (1) 153 (13) 722 (59) 310 (25) 39 (3) 448 (37) 63 (5) 713 (58) 18 (2) 132 (11) 977 (80) 63 (5) 34 (3)
Data are number of patients (%) unless otherwise stated. SD = standard deviation. a cTNM Stage X = if Tx and/or Nx and M not equal to M1.
Please cite this article in press as: Joye I et al. Does a central review platform improve the quality of radiotherapy for rectal cancer? Results of a national quality assurance project. Radiother Oncol (2014), http://dx.doi.org/10.1016/j.radonc.2014.03.003
3
I. Joye et al. / Radiotherapy and Oncology xxx (2014) xxx–xxx Table 2 Feedback per centre. Centre
Total (%)
Cases without modification (%)
Cases with modification (%)
Modification rejected (%)
Modification partly accepted (%)
Modification fully accepted (%)
No feedback on acceptance (%)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Total (%)
78 (6) 92 (8) 46 (4) 7 (1) 24 (2) 105 (9) 13 (1) 79 (7) 61 (5) 25 (2) 26 (2) 89 (7) 17 (1) 6 (1) 42 (3) 66 (5) 91 (7) 198 (16) 90 (7) 69 (6) 1224 (100)
6 (8) 5 (5) 4 (9) 0 (0) 7 (29) 37 (35) 1 (8) 20 (25) 7 (12) 0 (0) 0 (0) 25 (28) 10 (59) 3 (50) 7 (17) 18 (27) 15 (17) 149 (75) 5 (6) 5 (7) 315 (26)
72 (92) 87 (95) 42 (91) 7 (100) 17 (71) 68 (65) 12 (92) 59 (75) 54 (89) 25 (100) 26 (100) 64 (72) 7 (41) 3 (50) 35 (83) 48 (73) 76 (84) 49 (25) 85 (94) 64 (93) 909 (74)
3 (4) 11 (14) 2 (3) 3 (4) 7 (9) 1 (1) 8 (10) 11 (14) 4 (5) 4 (5) 0 (0) 37 (47) 3 (4) 0 (0) 5 (6) 7 (9) 0 (0) 21 (27) 7 (9) 24 (31) 158 (13)
3 (4) 0 (0) 1 (2) 0 (0) 0 (0) 1 (1) 3 (23) 0 (0) 14 (23) 1 (4) 0 (0) 0 (0) 4 (24) 0 (0) 0 (0) 4 (6) 1 (1) 1 (1) 4 (4) 0 (0) 37 (3)
63 (81) 66 (72) 36 (78) 1 (14) 4 (17) 64 (61) 1 (8) 40 (51) 36 (59) 14 (56) 0 (0) 27 (30) 9 (53) 2 (33) 28 (67) 30 (46) 75 (82) 27 (14) 63 (70) 36 (52) 622 (51)
3 (4) 10 (11) 3 (7) 3 (43) 6 (25) 2 (2) 0 (0) 8 (10) 0 (0) 6 (24) 26 (100) 0 (0) 0 (0) 1 (17) 2 (5) 7 (11) 0 (0) 0 (0) 11 (12) 4 (6) 92 (8)
Data are given in number of patients and as a percentage of the total number of patients. Cases without feedback represent those who needed modification and lacked the information about centres’ acceptance.
Table 3 Effect of patient order on RV, VCC and DC parameters adjusted on CTVsub and centre. Statistical model
Response variable
Independent variable
Parameter estimates Adjusted
GLM
RV
Cpatorder
LR
VCC = 100%
Cpatorder
LR
DC = 1
Cpatorder
First ten patients Others (ref) First ten patients (ref) Others First ten patients (ref) Others
0.03 1 1 1.65 1 1.43
p-value
95% CI [ 0.04; 0.12] – – [1.00; 2.73] – [0.85; 2.40]
Contents lists available at ScienceDirect
Radiotherapy and Oncology journal homepage: www.thegreenjournal.com
Original article
Does a central review platform improve the quality of radiotherapy for rectal cancer? Results of a national quality assurance project Ines Joye a,b, Maarten Lambrecht a,b, David Jegou c, Eszter Hortobágyi a,b, Pierre Scalliet d, Karin Haustermans a,b,⇑ a Department of Radiation Oncology, Leuven Cancer Institute, University Hospitals Leuven; b Department of Oncology, KU Leuven; c Department of Research, Belgian Cancer Registry, Brussels; and d Department of Radiation Oncology, Université Catholique de Louvain, Brussels, Belgium
a r t i c l e
i n f o
Article history: Received 15 November 2013 Received in revised form 12 February 2014 Accepted 4 March 2014 Available online xxxx Keywords: Rectal cancer Radiotherapy Target delineation Central review Quality assurance
a b s t r a c t Background and purpose: Quality assurance (QA) for radiation treatment has become a priority since poorly delivered radiotherapy can negatively influence patient outcome. Within a national project we evaluated the feasibility of a central review platform and its role in improving uniformity of clinical target volume (CTV) delineation in daily practice. Material and methods: All Belgian radiotherapy departments were invited to participate and were asked to upload CTVs for rectal cancer treatment onto a secured server. These were centrally reviewed and feedback was given per e-mail. For each five consecutive patients per centre, the overlap parameter dice coefficient (DC) and the volumetric parameters volumetric ratio (RV) and commonly contoured volume (VCC) were calculated. Results: Twenty departments submitted 1224 eligible cases of which 909 were modified (74.3%). There was a significant increase in RV and VCC between the first ten patients per centre and the others. This was not seen for DC. Statistical analysis did not show a further significant improvement in delineation over the entire review period. Conclusion: Central review was feasible and increased the uniformity in CTV delineation in the first ten rectal cancer patients per centre. The observations in this study can be used to optimize future QA initiatives. Ó 2014 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology xxx (2014) xxx–xxx
Colorectal cancer is the third most common cancer and accounts for the third most common cause of cancer-related death in the developed world [1]. Advances in screening, diagnosis and treatment have contributed to a better local control and an improved survival of rectal cancer over the past ten years. In order to maintain and further optimize outcome for rectal cancer patients, continuous focus on quality assurance (QA) and collective efforts of the multidisciplinary team members are mandatory. In this respect, training, centre’s experience and the quality of total mesorectal excision have proven to be important prognostic factors [2,3]. Furthermore, pathological feedback to surgeons has shown to be a powerful incentive to improve the resection quality [4,5]. Aside from surgery, radiotherapy is regarded as one of the cornerstones in the locoregional treatment of rectal cancer. Despite this crucial role, large multicentre trials have documented wide variations in the quality of radiotherapy [6–9]. Deviations in the ⇑ Corresponding author at: Leuven Cancer Institute, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium. E-mail address: [email protected] (K. Haustermans).
radiotherapy quality not only affect the validity of study results, they also might negatively influence outcome. Prospective quality control of radiotherapy equipment, treatment plans, dosimetric data and target volumes is therefore mandated. The importance of maintaining a uniform high treatment quality in the management of rectal cancer, has led to the launch of the Belgian initiative PROCARE (PROject on CAncer of the REctum) in 2006. The main objective of PROCARE, a voluntary multidisciplinary project, is to reduce diagnostic and therapeutic variability and thus improve outcome in rectal cancer patients treated in Belgium. Guidelines and quality indicators related to rectal cancer management have been developed by a multidisciplinary working group. Decentralized implementation of these guidelines, prospective registration of detailed patient data, feedback and benchmarking are keystones of this QA project. In an attempt to standardize radiotherapy for rectal cancer treatment, the PROCARE initiative set up a central review platform for clinical target volume (CTV) delineation. In this study we aimed to evaluate the feasibility of a central review platform and its value
http://dx.doi.org/10.1016/j.radonc.2014.03.003 0167-8140/Ó 2014 Elsevier Ireland Ltd. All rights reserved.
Please cite this article in press as: Joye I et al. Does a central review platform improve the quality of radiotherapy for rectal cancer? Results of a national quality assurance project. Radiother Oncol (2014), http://dx.doi.org/10.1016/j.radonc.2014.03.003
2
Impact of central review on CTV delineation
in improving uniformity of target volume delineation in daily practice. Material and methods
rections was left at the discretion of the treating physician. Feedback on which CTV was finally used for treatment planning was requested and classified as fully accepted, partly accepted, rejected or feedback missing. All data were archived at the Belgian Cancer Registry.
Study design In November 2009 a central review facility was established at the radiotherapy department of the University Hospitals Leuven (UHL) and of the Université Catholique de Louvain (UCL). Dedicated software (AquilabÒ, France) was used to set up a secured network between the review facilities and each participating radiotherapy department (Suppl. Fig. 1). All 25 radiation oncology departments in Belgium were invited to join this QA project. Centres were asked to delineate the CTV of each rectal cancer patient who was going to be irradiated. Delineation tools were distributed to all centres: the Belgian Healthcare Knowledge Centre guidelines on rectal cancer, internationally peer-reviewed CTV delineation guidelines, and a CTV delineation atlas, which had been discussed at a meeting of radiation oncologists from all Belgian radiotherapy departments [10,11]. The simulation protocol (contrast acquisition, patient positioning, slice thickness. . .) was left at the discretion of the participating centres. The submitted CTVs (CTVsub) were uploaded on a secured server. For each case a minimum of clinical information was required (age, gender, tumour localization, and cTNM staging). Review procedure A radiation technologist was trained in CTV delineation and reviewed all cases according to the guidelines at the UHL (Fig. 1) [11]. The first 50 delineations were reviewed under direct supervision of a senior radiation oncologist specialized in digestive oncology. This double-check procedure was repeated for every following 20th case. A radiologist was consulted if there were uncertainties about anatomical borders. Contourings of UHL patients were checked by a senior radiation oncologist of the UCL. The delineations were reviewed within 24 h and, if necessary, the modified CTV (CTVmod) was sent back to the original centre. Modifications were explained by e-mail. Acceptance or rejection of the proposed delineation cor-
Study population In March 2010 the review started with three centres, in May 2010 10 centres participated and in July 2011 there was a full operation between 20 centres. Between March 2010 and September 2012, 20 centres submitted 1255 rectal cancer cases. Since the manuscript of Roels et al. does not provide guidelines on delineation of the inguinal lymph nodes, cases in which inguinal irradiation was suggested (n = 6) were excluded [11]. Review was lacking in 25 cases. A total of 1224 rectal cancer cases were analysed.
Delineation agreement analysis For each patient the overlap parameter dice coefficient (DC) and volumetric parameters volumetric ratio (RV) and commonly contoured volume (VCC) were calculated. DC represents the ratio between the overlapping volume and the encompassing volume with the numerator multiplied by two. RV is the ratio between the CTVsub and CTVmod volume and VCC represents the percentage of the CTVmod which is irradiated (Suppl. Fig. 2). For all centres combined, we investigated whether the agreement improved over time after entry into the project. In order to account for the variability in the time of inclusion between two patients in one centre and between centres, we used a ranking system in which each five
Table 1 Patient demographics (n = 1224). Number (%) Gender Male Female
828 (68) 396 (32)
Mean (SD) Range (min–max) Missing
65.7 (11.1) 23.3–91.6 29
High Mid Low
232 (19) 390 (32) 602 (49)
Age
Tumour location
Tumour classification T1 T2 T3 T4 Tx Lymph node classification N0 N1 N2 Nx Metastasis classification M0 M1 Mx cTNM stage I II III IV Xa Fig. 1. Example of a submitted case with modification. The submitted CTV is depicted by a solid line, the suggested modifications are represented by a dashed line. In this case, the external iliac vessels were excluded because the patient had a high-seated tumour without invasion of the anterior organs.
6 (1) 122 (10) 970 (79) 110 (9) 16 (1) 153 (13) 722 (59) 310 (25) 39 (3) 448 (37) 63 (5) 713 (58) 18 (2) 132 (11) 977 (80) 63 (5) 34 (3)
Data are number of patients (%) unless otherwise stated. SD = standard deviation. a cTNM Stage X = if Tx and/or Nx and M not equal to M1.
Please cite this article in press as: Joye I et al. Does a central review platform improve the quality of radiotherapy for rectal cancer? Results of a national quality assurance project. Radiother Oncol (2014), http://dx.doi.org/10.1016/j.radonc.2014.03.003
3
I. Joye et al. / Radiotherapy and Oncology xxx (2014) xxx–xxx Table 2 Feedback per centre. Centre
Total (%)
Cases without modification (%)
Cases with modification (%)
Modification rejected (%)
Modification partly accepted (%)
Modification fully accepted (%)
No feedback on acceptance (%)
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Total (%)
78 (6) 92 (8) 46 (4) 7 (1) 24 (2) 105 (9) 13 (1) 79 (7) 61 (5) 25 (2) 26 (2) 89 (7) 17 (1) 6 (1) 42 (3) 66 (5) 91 (7) 198 (16) 90 (7) 69 (6) 1224 (100)
6 (8) 5 (5) 4 (9) 0 (0) 7 (29) 37 (35) 1 (8) 20 (25) 7 (12) 0 (0) 0 (0) 25 (28) 10 (59) 3 (50) 7 (17) 18 (27) 15 (17) 149 (75) 5 (6) 5 (7) 315 (26)
72 (92) 87 (95) 42 (91) 7 (100) 17 (71) 68 (65) 12 (92) 59 (75) 54 (89) 25 (100) 26 (100) 64 (72) 7 (41) 3 (50) 35 (83) 48 (73) 76 (84) 49 (25) 85 (94) 64 (93) 909 (74)
3 (4) 11 (14) 2 (3) 3 (4) 7 (9) 1 (1) 8 (10) 11 (14) 4 (5) 4 (5) 0 (0) 37 (47) 3 (4) 0 (0) 5 (6) 7 (9) 0 (0) 21 (27) 7 (9) 24 (31) 158 (13)
3 (4) 0 (0) 1 (2) 0 (0) 0 (0) 1 (1) 3 (23) 0 (0) 14 (23) 1 (4) 0 (0) 0 (0) 4 (24) 0 (0) 0 (0) 4 (6) 1 (1) 1 (1) 4 (4) 0 (0) 37 (3)
63 (81) 66 (72) 36 (78) 1 (14) 4 (17) 64 (61) 1 (8) 40 (51) 36 (59) 14 (56) 0 (0) 27 (30) 9 (53) 2 (33) 28 (67) 30 (46) 75 (82) 27 (14) 63 (70) 36 (52) 622 (51)
3 (4) 10 (11) 3 (7) 3 (43) 6 (25) 2 (2) 0 (0) 8 (10) 0 (0) 6 (24) 26 (100) 0 (0) 0 (0) 1 (17) 2 (5) 7 (11) 0 (0) 0 (0) 11 (12) 4 (6) 92 (8)
Data are given in number of patients and as a percentage of the total number of patients. Cases without feedback represent those who needed modification and lacked the information about centres’ acceptance.
Table 3 Effect of patient order on RV, VCC and DC parameters adjusted on CTVsub and centre. Statistical model
Response variable
Independent variable
Parameter estimates Adjusted
GLM
RV
Cpatorder
LR
VCC = 100%
Cpatorder
LR
DC = 1
Cpatorder
First ten patients Others (ref) First ten patients (ref) Others First ten patients (ref) Others
0.03 1 1 1.65 1 1.43
p-value
95% CI [ 0.04; 0.12] – – [1.00; 2.73] – [0.85; 2.40]
