- Email: [email protected]
Making Advances in Quality of Life Studies in Head and Neck Cancer
International Journal of
Radiation Oncology biology
physics
www.redjournal.org
EDITORIAL
Making Advances in Quality of Life Studies in Head and Neck Cancer Kristin Bjordal, MD, PhD,* and Andrew Bottomley, PhDy *Division of Medicine, University of Oslo, Oslo, Norway; and yQuality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium Received Nov 18, 2016. Accepted for publication Nov 28, 2016.
Quality of life (QOL) research has been around for decades and currently is commonplace in cancer clinical trials. Clinical trialists now have robust tools to quickly identify the issues facing patients that arise from their disease and treatment. However, globally there is still some resistance (to efforts) to include assessments of QOL, or patientreported outcome measures (PROs) in cancer clinical trials. It is time to recognize that the world has moved to the position where patient views matter. Major patient-focused organizations exist to promote better methodologies and use of PROs, such as the US Patient-Centered Outcomes Research Institute or the International Society for Quality of Life Research. In patients with head and neck cancer (HNC), QOL assessments have been recognized as very important, often owing to the extensive functional impact of disease and treatment. For years we have had available robust, well-validated tools (1, 2), but there are fewer publications and QOL studies in HNC than for other disease sites (3). Therefore, PROs from large clinical trials in these patients are welcomed. Major efforts to address common methodologic limitations seen in the HNC literature (eg, Murphy et al [3]) are evident in the 4 articles published in this issue of the Red Journal. These advances mean that if you are still in the skeptic’s camp, it is time to challenge your perceptions. You will realise that QOL is ready for prime time and that our new QOL studies in HNC are adding value to the field. Take, for instance, the Radiation Therapy Oncology Group 0129 trial reported by Xiao et al in this issue (4). This article reports a very well conducted trial of standard
radiation versus accelerated radiation plus cisplatin for locally advanced HNC. Although no QOL differences were seen, even though it was initiated in 2002, this trial illustrates the good design that we see nowadays: it shows the use of robust, cancer-specific measures, a design powered to detect differences, and it includes long-term 5-year follow-up. Importantly, Xiao et al even address issues of design, such as minimal important differences, an issue often not cited in trials (4). The result that QOL before treatment was an independent prognostic factor for survival is typically reported in most trials (5-7). Quality of life has been recommended by many to be used as a stratification factor in future trials, but it is rarely done. The other important finding was that the analysis showed that positive p16 status was associated with QOL, with better QOL before and after treatment but with larger decrements during treatment. This finding has been demonstrated in other studies as well. Indeed, that is just what can be seen in the Trans Tasman Radiation Oncology Group (TROG) 02.02/ HeadSTART international phase 3 trial reported by Ringash et al (8). In a subgroup analysis of this randomized, controlled trial (RCT), further attempts were made to examine the impact of p16 status on QOL, for 200 patients with locally advanced oropharyngeal cancer (OPC) undergoing chemoradiotherapy. The authors reported that both p16 positivity and baseline QOL scores independently predict survival after concurrent chemoradiotherapy, and again, the results suggest that patients with p16þ OPC had better baseline QOL, but a more major QOL drop with concurrent chemoradiation. The clinical recommendations
Reprint requests to: Andrew Bottomley, PhD, Quality of Life Department, European Organisation for Research and Treatment of Cancer, 83/11
Ave E. Mounier, 1200 Brussels, Belgium. Tel: (þ32) 2-774-16-61; E-mail: [email protected] Conflict of interest: none.
Int J Radiation Oncol Biol Phys, Vol. 97, No. 4, pp. 659e661, 2017 0360-3016/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ijrobp.2016.11.051
660
Bjordal and Bottomley
could be major, supporting the idea of reducing the intensity of treatment to improve their QOL without compromising the favorable prognosis of p16þ OPC. These results are strong and have major credibility. The researchers used robust measures, reported the results within the context of which findings were clinically significant, and presented the results with rigorous statistical methods. Yet, as the authors note, these results are based on a subset analysis and therefore are ideal for generation of future research ideas, rather than setting new standards of care. Truong et al (9) report QOL in a phase 3 RCT of concurrent accelerated radiation plus cisplatin with or without cetuximab for locally advanced HNC in the NRG Oncology/Radiation Therapy Oncology Group 0522 study. This is another example of a well-planned and -executed trial, using a large sample size of 818 patients and collecting QOL data with robust and HNC-specific measures, with a clearly defined, preplanned hypothesis. These QOL findings showed few differences between arms; they also highlight the challenges that can be posed by long-term follow updnoting, for example, that follow-up beyond 2 years can be difficultdand questioning its value in future trials. Although we tend to agree with this view, and it is often reported as a challenge in other HNC international clinical trials (10, 11), long-term follow-up and survivorship becomes an increasingly important issue in today’s society and in HNC (12). If PROs are implemented as a compulsory part at baseline, as in many National Cancer Institute of Canada studies, a 100% initial participation will provide more robust datasets. Perhaps it is time for investigators to better explore ways to achieve better followup. For example, better infrastructure and detailed instructions in the protocol may reduce administrative failures. Further research into efforts to raise long-term compliance is also needed (13). We are seeing many trials now moving to electronic PROs, which are often common in industry-funded trials. Because the guidance for use of QOL electronic assessment in trials is fast developing (14, 15), and as guidelines are tried and tested (16), it is very likely that within 5 years the vast majority of major cancer clinical trials’ QOL data will be collected electronically, and such approaches are bound to improve compliance and allow easier long-term follow-up. Indeed, the European Organisation for Research and Treatment of Cancer (EORTC) currently has plans that by 2018, all EORTC clinical trials, including in HNC, will be evaluated electronically. The article by Goepfert et al (17) reports an important methodologic study to help understand the value and support of the interpretation of swallowing outcomes when using the M. D. Anderson Dysphagia Inventory scale. Such methodologic studies are critical if we are to understand how to interpret the PROs from clinical trials. Indeed, these findings add strength to and shed light on the measure and thus can help in planning future trials with this tool.
International Journal of Radiation Oncology Biology Physics
However, they were built on a pooled analysis of only 46 patients from 3 trials, and as the investigators note themselves, missing data is a challenging factor in this methodologic study. Nevertheless, these data contribute to informing the interpretation and design of future clinical trials. Overall, these 4 articles add to our deeper understanding of QOL in HNC patients. They illustrate the breadth of knowledge that is needed and the major steps we have to make to better understand the QOL of our patients. Of course, these articles have limitations: for example, although the clinical trials were written up according to CONSORT, the authors did not report applying the CONSORT PRO extension standard (18). The CONSORT PRO extension has been developed to help address the shortcomings of reporting found in numerous PRO trials over the past decade. Specifically, it extends 5 items of the CONSORT 2010 checklist to facilitate optimal reporting of RCTs in which PROs are primary or secondary endpoints. Such a way of standardizing is needed, not only in HNC but across reporting of all clinical trials. However, a recent review of the early impact of the CONSORT PRO extension (19) has illustrated that it is not applied, which suggests more effort is needed to promote the CONSORT PRO extension on a global basis. Furthermore, although the 3 trials reported in these articles had robust appropriate analysis, it is time we now standardized the QOL analysis methods used across all trialsdagain, this is a challenge not only for HNC but in all clinical trials reporting QOL results. Critical efforts are currently underway and need to be accelerated to recommend standardized approaches that authors can use for the analysis of QOL data going forward (20). Hopefully, PROs, not observer-rated QOL, will be a secondary outcome for patients in a HNC RCT if improved survival is the aim of the study. On the other hand, in future trials of p16-positive OPC patients, QOL should be considered as a primary outcome in addition to survival, and stratification based on the baseline prerandomization QOL should be considered. The reality is that there are no shortcuts to understanding QOL in HNC, and it is only through major efforts in the design of clinical trials and critically needed moremethodologic work that progress can be made. These 4 publications add to the growing body of literature in HNC and illustrate an impressive pedigree of work that has been done and that we fully expect will continue to be undertaken in the future.
References 1. Ringash J, Bezjak A. A structured review of quality of life instruments for head and neck cancer patients. Head Neck 2001;23:201-213. 2. Bjordal K, de Graeff A, Fayers PM, et al. A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer
Volume 97 Number 4 2017
3.
4.
5.
6.
7.
8.
9.
10.
11.
specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group. Eur J Cancer 2000;36:1796-1807. Murphy BA, Ridner S, Wells N, et al. Quality of life research in head and neck cancer: A review of the current state of the science. Crit Rev Oncol Hematol 2007;62:251-267. Xiao C, Zhang Q, Nguyen-Taˆn PF, et al. Quality of life and performance status from a sub-study conducted within a prospective phase III randomized trial of concurrent standard radiation vs. accelerated radiation plus cisplatin for locally advanced head and neck carcinoma: NRG Oncology RTOG 0129. Int J Radiat Oncol Biol Phys 2017;97: 667-677. Cramarossa G, Chow E, Zhang L, et al. Predictive factors for overall quality of life in patients with advanced cancer. Support Care Cancer 2013;21:1709-1716. van Nieuwenhuizen AJ, Buffart LM, Brug J, et al. The association between health related quality of life and survival in patients with head and neck cancer: A systematic review. Oral Oncol 2015;51:1-11. Quinten C, Maringwa J, Gotay CC, et al. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst 2011;103:1851-1858. Ringash J, Fisher R, Peters L, et al. Effect of P16 status on the qualityof-life experience during chemoradiation for locally advanced oropharyngeal cancer: A substudy of randomized trial trans-tasman radiation oncology group TROG 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys 2017;97:678-686. Truong MT, Zhang Q, Rosenthal DI, et al. Quality of life and performance status from a substudy conducted within a prospective phase 3 randomized trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for locally advanced head and neck carcinoma: NRG oncology radiation therapy oncology group 0522. Int J Radiat Oncol Biol Phys 2017;97:687-699. Bottomley A, Tridello G, Coens C, et al. An international phase 3 trial in head and neck cancer: Quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer 2014;120:390-398. van Herpen CM, Mauer ME, Mesia R, et al. Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-
Making advances in QoL studies in HNC
12. 13.
14.
15.
16.
17.
18.
19.
20.
661
fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). Br J Cancer 2010;103:1173-1181. Ringash J. Survivorship and quality of life in head and neck cancer. J Clin Oncol 2015;33:3322-3327. Wintner LM, Sztankay M, Aaronson N, et al. The use of EORTC measures in daily clinical practiceda synopsis of a newly developed manual. Eur J Cancer 2016;68:73-81. Fleming S, Barsdorf AI, Howry C, et al. Optimizing electronic capture of clinical outcome assessment data in clinical trials. The case of patient-reported endpoints. Ther Innov Regul Sci 2015;49:797804. Gwaltney CJ, Coons SJ, O’Donohoe P, et al. Bring your own device (BYOD): The future of field-based patient-reported outcome data collection in clinical trials? Ther Innov Regul Sci 2015;49:783791. Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health 2009; 12:419-429. Goepfert RP, Lewin JS, Barrow MP, et al. Long-term, prospective performance of the M.D. Anderson Dysphagia Inventory in “low-intermediate risk” oropharyngeal carcinoma after intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys 2017;97:700-708. Calvert M, Brundage M, Jacobsen PB, et al. The CONSORT PatientReported Outcome (PRO) extension: Implications for clinical trials and practice. Health Qual Life Outcomes 2013;11:184. Mercieca-Bebber RL, Calvert MJ, King M, et al. Preliminary evidence on the uptake and use of the CONSORT-PRO extension: A review on behalf of the ISOQOL Best Practices for PROs Reporting Taskforce. 23rd Annual Conference for the International Society for Quality of Life Research, Copenhagen (Denmark), 19-22 October 2016. Qual Life Res 2016;25:22-23. Bottomley A, Pe M, Sloan J, et al. Analysing data from patientreported outcome and quality of life endpoints for cancer clinical trials: A start in setting international standards. Lancet Oncol 2016;17: e510-e514.
Radiation Oncology biology
physics
www.redjournal.org
EDITORIAL
Making Advances in Quality of Life Studies in Head and Neck Cancer Kristin Bjordal, MD, PhD,* and Andrew Bottomley, PhDy *Division of Medicine, University of Oslo, Oslo, Norway; and yQuality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium Received Nov 18, 2016. Accepted for publication Nov 28, 2016.
Quality of life (QOL) research has been around for decades and currently is commonplace in cancer clinical trials. Clinical trialists now have robust tools to quickly identify the issues facing patients that arise from their disease and treatment. However, globally there is still some resistance (to efforts) to include assessments of QOL, or patientreported outcome measures (PROs) in cancer clinical trials. It is time to recognize that the world has moved to the position where patient views matter. Major patient-focused organizations exist to promote better methodologies and use of PROs, such as the US Patient-Centered Outcomes Research Institute or the International Society for Quality of Life Research. In patients with head and neck cancer (HNC), QOL assessments have been recognized as very important, often owing to the extensive functional impact of disease and treatment. For years we have had available robust, well-validated tools (1, 2), but there are fewer publications and QOL studies in HNC than for other disease sites (3). Therefore, PROs from large clinical trials in these patients are welcomed. Major efforts to address common methodologic limitations seen in the HNC literature (eg, Murphy et al [3]) are evident in the 4 articles published in this issue of the Red Journal. These advances mean that if you are still in the skeptic’s camp, it is time to challenge your perceptions. You will realise that QOL is ready for prime time and that our new QOL studies in HNC are adding value to the field. Take, for instance, the Radiation Therapy Oncology Group 0129 trial reported by Xiao et al in this issue (4). This article reports a very well conducted trial of standard
radiation versus accelerated radiation plus cisplatin for locally advanced HNC. Although no QOL differences were seen, even though it was initiated in 2002, this trial illustrates the good design that we see nowadays: it shows the use of robust, cancer-specific measures, a design powered to detect differences, and it includes long-term 5-year follow-up. Importantly, Xiao et al even address issues of design, such as minimal important differences, an issue often not cited in trials (4). The result that QOL before treatment was an independent prognostic factor for survival is typically reported in most trials (5-7). Quality of life has been recommended by many to be used as a stratification factor in future trials, but it is rarely done. The other important finding was that the analysis showed that positive p16 status was associated with QOL, with better QOL before and after treatment but with larger decrements during treatment. This finding has been demonstrated in other studies as well. Indeed, that is just what can be seen in the Trans Tasman Radiation Oncology Group (TROG) 02.02/ HeadSTART international phase 3 trial reported by Ringash et al (8). In a subgroup analysis of this randomized, controlled trial (RCT), further attempts were made to examine the impact of p16 status on QOL, for 200 patients with locally advanced oropharyngeal cancer (OPC) undergoing chemoradiotherapy. The authors reported that both p16 positivity and baseline QOL scores independently predict survival after concurrent chemoradiotherapy, and again, the results suggest that patients with p16þ OPC had better baseline QOL, but a more major QOL drop with concurrent chemoradiation. The clinical recommendations
Reprint requests to: Andrew Bottomley, PhD, Quality of Life Department, European Organisation for Research and Treatment of Cancer, 83/11
Ave E. Mounier, 1200 Brussels, Belgium. Tel: (þ32) 2-774-16-61; E-mail: [email protected] Conflict of interest: none.
Int J Radiation Oncol Biol Phys, Vol. 97, No. 4, pp. 659e661, 2017 0360-3016/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ijrobp.2016.11.051
660
Bjordal and Bottomley
could be major, supporting the idea of reducing the intensity of treatment to improve their QOL without compromising the favorable prognosis of p16þ OPC. These results are strong and have major credibility. The researchers used robust measures, reported the results within the context of which findings were clinically significant, and presented the results with rigorous statistical methods. Yet, as the authors note, these results are based on a subset analysis and therefore are ideal for generation of future research ideas, rather than setting new standards of care. Truong et al (9) report QOL in a phase 3 RCT of concurrent accelerated radiation plus cisplatin with or without cetuximab for locally advanced HNC in the NRG Oncology/Radiation Therapy Oncology Group 0522 study. This is another example of a well-planned and -executed trial, using a large sample size of 818 patients and collecting QOL data with robust and HNC-specific measures, with a clearly defined, preplanned hypothesis. These QOL findings showed few differences between arms; they also highlight the challenges that can be posed by long-term follow updnoting, for example, that follow-up beyond 2 years can be difficultdand questioning its value in future trials. Although we tend to agree with this view, and it is often reported as a challenge in other HNC international clinical trials (10, 11), long-term follow-up and survivorship becomes an increasingly important issue in today’s society and in HNC (12). If PROs are implemented as a compulsory part at baseline, as in many National Cancer Institute of Canada studies, a 100% initial participation will provide more robust datasets. Perhaps it is time for investigators to better explore ways to achieve better followup. For example, better infrastructure and detailed instructions in the protocol may reduce administrative failures. Further research into efforts to raise long-term compliance is also needed (13). We are seeing many trials now moving to electronic PROs, which are often common in industry-funded trials. Because the guidance for use of QOL electronic assessment in trials is fast developing (14, 15), and as guidelines are tried and tested (16), it is very likely that within 5 years the vast majority of major cancer clinical trials’ QOL data will be collected electronically, and such approaches are bound to improve compliance and allow easier long-term follow-up. Indeed, the European Organisation for Research and Treatment of Cancer (EORTC) currently has plans that by 2018, all EORTC clinical trials, including in HNC, will be evaluated electronically. The article by Goepfert et al (17) reports an important methodologic study to help understand the value and support of the interpretation of swallowing outcomes when using the M. D. Anderson Dysphagia Inventory scale. Such methodologic studies are critical if we are to understand how to interpret the PROs from clinical trials. Indeed, these findings add strength to and shed light on the measure and thus can help in planning future trials with this tool.
International Journal of Radiation Oncology Biology Physics
However, they were built on a pooled analysis of only 46 patients from 3 trials, and as the investigators note themselves, missing data is a challenging factor in this methodologic study. Nevertheless, these data contribute to informing the interpretation and design of future clinical trials. Overall, these 4 articles add to our deeper understanding of QOL in HNC patients. They illustrate the breadth of knowledge that is needed and the major steps we have to make to better understand the QOL of our patients. Of course, these articles have limitations: for example, although the clinical trials were written up according to CONSORT, the authors did not report applying the CONSORT PRO extension standard (18). The CONSORT PRO extension has been developed to help address the shortcomings of reporting found in numerous PRO trials over the past decade. Specifically, it extends 5 items of the CONSORT 2010 checklist to facilitate optimal reporting of RCTs in which PROs are primary or secondary endpoints. Such a way of standardizing is needed, not only in HNC but across reporting of all clinical trials. However, a recent review of the early impact of the CONSORT PRO extension (19) has illustrated that it is not applied, which suggests more effort is needed to promote the CONSORT PRO extension on a global basis. Furthermore, although the 3 trials reported in these articles had robust appropriate analysis, it is time we now standardized the QOL analysis methods used across all trialsdagain, this is a challenge not only for HNC but in all clinical trials reporting QOL results. Critical efforts are currently underway and need to be accelerated to recommend standardized approaches that authors can use for the analysis of QOL data going forward (20). Hopefully, PROs, not observer-rated QOL, will be a secondary outcome for patients in a HNC RCT if improved survival is the aim of the study. On the other hand, in future trials of p16-positive OPC patients, QOL should be considered as a primary outcome in addition to survival, and stratification based on the baseline prerandomization QOL should be considered. The reality is that there are no shortcuts to understanding QOL in HNC, and it is only through major efforts in the design of clinical trials and critically needed moremethodologic work that progress can be made. These 4 publications add to the growing body of literature in HNC and illustrate an impressive pedigree of work that has been done and that we fully expect will continue to be undertaken in the future.
References 1. Ringash J, Bezjak A. A structured review of quality of life instruments for head and neck cancer patients. Head Neck 2001;23:201-213. 2. Bjordal K, de Graeff A, Fayers PM, et al. A 12 country field study of the EORTC QLQ-C30 (version 3.0) and the head and neck cancer
Volume 97 Number 4 2017
3.
4.
5.
6.
7.
8.
9.
10.
11.
specific module (EORTC QLQ-H&N35) in head and neck patients. EORTC Quality of Life Group. Eur J Cancer 2000;36:1796-1807. Murphy BA, Ridner S, Wells N, et al. Quality of life research in head and neck cancer: A review of the current state of the science. Crit Rev Oncol Hematol 2007;62:251-267. Xiao C, Zhang Q, Nguyen-Taˆn PF, et al. Quality of life and performance status from a sub-study conducted within a prospective phase III randomized trial of concurrent standard radiation vs. accelerated radiation plus cisplatin for locally advanced head and neck carcinoma: NRG Oncology RTOG 0129. Int J Radiat Oncol Biol Phys 2017;97: 667-677. Cramarossa G, Chow E, Zhang L, et al. Predictive factors for overall quality of life in patients with advanced cancer. Support Care Cancer 2013;21:1709-1716. van Nieuwenhuizen AJ, Buffart LM, Brug J, et al. The association between health related quality of life and survival in patients with head and neck cancer: A systematic review. Oral Oncol 2015;51:1-11. Quinten C, Maringwa J, Gotay CC, et al. Patient self-reports of symptoms and clinician ratings as predictors of overall cancer survival. J Natl Cancer Inst 2011;103:1851-1858. Ringash J, Fisher R, Peters L, et al. Effect of P16 status on the qualityof-life experience during chemoradiation for locally advanced oropharyngeal cancer: A substudy of randomized trial trans-tasman radiation oncology group TROG 02.02 (HeadSTART). Int J Radiat Oncol Biol Phys 2017;97:678-686. Truong MT, Zhang Q, Rosenthal DI, et al. Quality of life and performance status from a substudy conducted within a prospective phase 3 randomized trial of concurrent accelerated radiation plus cisplatin with or without cetuximab for locally advanced head and neck carcinoma: NRG oncology radiation therapy oncology group 0522. Int J Radiat Oncol Biol Phys 2017;97:687-699. Bottomley A, Tridello G, Coens C, et al. An international phase 3 trial in head and neck cancer: Quality of life and symptom results: EORTC 24954 on behalf of the EORTC Head and Neck and the EORTC Radiation Oncology Group. Cancer 2014;120:390-398. van Herpen CM, Mauer ME, Mesia R, et al. Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-
Making advances in QoL studies in HNC
12. 13.
14.
15.
16.
17.
18.
19.
20.
661
fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). Br J Cancer 2010;103:1173-1181. Ringash J. Survivorship and quality of life in head and neck cancer. J Clin Oncol 2015;33:3322-3327. Wintner LM, Sztankay M, Aaronson N, et al. The use of EORTC measures in daily clinical practiceda synopsis of a newly developed manual. Eur J Cancer 2016;68:73-81. Fleming S, Barsdorf AI, Howry C, et al. Optimizing electronic capture of clinical outcome assessment data in clinical trials. The case of patient-reported endpoints. Ther Innov Regul Sci 2015;49:797804. Gwaltney CJ, Coons SJ, O’Donohoe P, et al. Bring your own device (BYOD): The future of field-based patient-reported outcome data collection in clinical trials? Ther Innov Regul Sci 2015;49:783791. Coons SJ, Gwaltney CJ, Hays RD, et al. Recommendations on evidence needed to support measurement equivalence between electronic and paper-based patient-reported outcome (PRO) measures: ISPOR ePRO Good Research Practices Task Force report. Value Health 2009; 12:419-429. Goepfert RP, Lewin JS, Barrow MP, et al. Long-term, prospective performance of the M.D. Anderson Dysphagia Inventory in “low-intermediate risk” oropharyngeal carcinoma after intensity modulated radiation therapy. Int J Radiat Oncol Biol Phys 2017;97:700-708. Calvert M, Brundage M, Jacobsen PB, et al. The CONSORT PatientReported Outcome (PRO) extension: Implications for clinical trials and practice. Health Qual Life Outcomes 2013;11:184. Mercieca-Bebber RL, Calvert MJ, King M, et al. Preliminary evidence on the uptake and use of the CONSORT-PRO extension: A review on behalf of the ISOQOL Best Practices for PROs Reporting Taskforce. 23rd Annual Conference for the International Society for Quality of Life Research, Copenhagen (Denmark), 19-22 October 2016. Qual Life Res 2016;25:22-23. Bottomley A, Pe M, Sloan J, et al. Analysing data from patientreported outcome and quality of life endpoints for cancer clinical trials: A start in setting international standards. Lancet Oncol 2016;17: e510-e514.