Annelotte C.M. van Bommel

A standard set of value-based patient-centered outcomes for breast cancer: The International Consortium for Health Outcomes Measurement (ICHOM) initiative

A major challenge in value-based health care is the lack of standardized health outcomes measurements, hindering optimal monitoring and comparison of the quality of health care across different settings globally. The International Consortium for Health Outcomes Measurement (ICHOM) assembled a multidisciplinary international working group, comprised of 26 health care providers and patient advocates, to develop a standard set of value-based patient-centered outcomes for breast cancer (BC). The working group convened via 8 teleconferences and completed a follow-up survey after each meeting. A modified 2-round Delphi method was used to achieve consensus on the outcomes and case-mix variables to be included. Patient focus group meetings (8 early or metastatic BC patients) and online anonymized surveys of 1225 multinational BC patients and survivors were also conducted to obtain patients’ input. The standard set encompasses survival and cancer control, and disutility of care (eg, acute treatment complications) outcomes, to be collected through administrative data and/or clinical records. A combination of multiple patient-reported outcomes measurement (PROM) tools is recommended to capture long-term degree of health outcomes. Selected case-mix factors were recommended to be collected at baseline. The ICHOM will endeavor to achieve wide buy-in of this set and facilitate its implementation in routine clinical practice in various settings and institutions worldwide.

Development of a Standardized Set of Patient-centered Outcomes for Advanced Prostate Cancer: An International Effort for a Unified Approach

BACKGROUND There are no universally monitored outcomes relevant to men with advanced prostate cancer, making it challenging to compare health outcomes between populations. OBJECTIVE We sought to develop a standard set of outcomes relevant to men with advanced prostate cancer to follow during routine clinical care. DESIGN, SETTING, AND PARTICIPANTS The International Consortium for Health Outcomes Measurement assembled a multidisciplinary working group to develop the set. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS We used a modified Delphi method to achieve consensus regarding the outcomes, measures, and case mix factors included. RESULTS AND LIMITATIONS The 25 members of the multidisciplinary international working group represented academic and nonacademic centers, registries, and patients. Recognizing the heterogeneity of men with advanced prostate cancer, the group defined the scope as men with all stages of incurable prostate cancer (metastatic and biochemical recurrence ineligible for further curative therapy). We defined outcomes important to all men, such as overall survival, and measures specific to subgroups, such as time to metastasis. Measures gathered from clinical data include measures of disease control. We also identified patient-reported outcome measures (PROMs), such as degree of urinary, bowel, and erectile dysfunction, mood symptoms, and pain control. CONCLUSIONS The international multidisciplinary group identified clinical data and PROMs that serve as a basis for international health outcome comparisons and quality-of-care assessments. The set will be revised annually. PATIENT SUMMARY Our international group has recommended a standardized set of patient-centered outcomes to be followed during routine care for all men with advanced prostate cancer.

Defining a standard set of patient-centred outcomes for lung cancer

In lung cancer, outcome measurement has been mostly limited to survival. Proper assessment of the value of lung cancer treatments, and the performance of institutions delivering care, requires more comprehensive measurement of standardised outcomes. The International Consortium for Health Outcomes Measurement convened an international, multidisciplinary working group of patient representatives, medical oncologists, surgeons, radiation oncologists, pulmonologists, palliative care specialists, registry experts and specialist nurses to review existing data and practices. Using a modified Delphi method, the group developed a consensus recommendation (“the set”) on the outcomes most essential to track for patients with lung cancer, along with baseline demographic, clinical and tumour characteristics (case-mix variables) for risk adjustment. The set applies to patients diagnosed with nonsmall cell lung cancer and small cell lung cancer. Our working group recommends the collection of the following outcomes: survival, complications during or within 6 months of treatment and patient-reported domains of health-related quality of life including pain, fatigue, cough and dyspnoea. Case-mix variables were defined to improve interpretation of comparisons. We defined an international consensus recommendation of the most important outcomes for lung cancer patients, along with relevant case-mix variables, and are working to support adoption and reporting of these measures globally. #ICHOM Lung Cancer Standard Set of patient-centred outcomes: aligning global efforts to improve lung cancer care http://ow.ly/bFDR300EhY7

Clinical auditing as an instrument for quality improvement in breast cancer care in the Netherlands: The national NABON Breast Cancer Audit

In 2011, the NABON Breast Cancer Audit (NBCA) was instituted as a nation‐wide audit to address quality of breast cancer care and guideline adherence in the Netherlands. The development of the NBCA and the results of 4 years of auditing are described.

An International Collaborative Standardizing a Comprehensive Patient-Centered Outcomes Measurement Set for Colorectal Cancer

Importance Global health systems are shifting toward value-based care in an effort to drive better outcomes in the setting of rising health care costs. This shift requires a common definition of value, starting with the outcomes that matter most to patients. Objective The International Consortium for Health Outcomes Measurement (ICHOM), a nonprofit initiative, was formed to define standard sets of outcomes by medical condition. In this article, we report the efforts of ICHOM’s working group in colorectal cancer. Evidence Review The working group was composed of multidisciplinary oncology specialists in medicine, surgery, radiation therapy, palliative care, nursing, and pathology, along with patient representatives. Through a modified Delphi process during 8 months (July 8, 2015 to February 29, 2016), ICHOM led the working group to a consensus on a final recommended standard set. The process was supported by a systematic PubMed literature review (1042 randomized clinical trials and guidelines from June 3, 2005, to June 3, 2015), a patient focus group (11 patients with early and metastatic colorectal cancer convened during a teleconference in August 2015), and a patient validation survey (among 276 patients with and survivors of colorectal cancer between October 15, 2015, and November 4, 2015). Findings After consolidating findings of the literature review and focus group meeting, a list of 40 outcomes was presented to the WG and underwent voting. The final recommendation includes outcomes in the following categories: survival and disease control, disutility of care, degree of health, and quality of death. Selected case-mix factors were recommended to be collected at baseline to facilitate comparison of results across treatments and health care professionals. Conclusions A standardized set of patient-centered outcome measures to inform value-based health care in colorectal cancer was developed. Pilot efforts are under way to measure the standard set among members of the working group.

Impact of 70-Gene Signature Use on Adjuvant Chemotherapy Decisions in Patients With Estrogen Receptor–Positive Early Breast Cancer: Results of a Prospective Cohort Study

Purpose Gene-expression profiles increasingly are used in addition to conventional prognostic factors to guide adjuvant chemotherapy (CT) decisions. The Dutch guideline suggests use of validated gene-expression profiles in patients with estrogen receptor (ER) -positive, early-stage breast cancer without overt lymph node metastases. We aimed to assess the impact of a 70-gene signature (70-GS) test on CT decisions in patients with ER-positive, early-stage breast cancer. Patients and Methods In a prospective, observational, multicenter study in patients younger than 70 years old who had undergone surgery for ER-positive, early-stage breast cancer, physicians were asked whether they intended to administer adjuvant CT before deployment of the 70-GS test and after the test result was available. Results Between October 1, 2013, and December 31, 2015, 660 patients, treated in 33 hospitals, were enrolled. Fifty-one percent of patients had pT1cN0, BRII, HER2-Neu-negative breast cancer. On the basis of conventional clinicopathological characteristics, physicians recommended CT in 270 (41%) of the 660 patients and recommended withholding CT in 107 (16%) of the 660 patients. For the remaining 43% of patients, the physicians were unsure and unable to give advice before 70-GS testing. In patients for whom CT was initially recommended or not recommended, 56% and 59%, respectively, were assigned to a low-risk profile by the 70-GS (κ, 0.02; 95% CI, -0.08 to 0.11). After disclosure of the 70-GS test result, the preliminary advice was changed in 51% of patients who received a recommendation before testing; the definitive CT recommendation of the physician was in line with the 70-GS result in 96% of patients. Conclusion In this prospective, multicenter study in a selection of patients with ER-positive, early-stage breast cancer, 70-GS use changed the physician-intended recommendation to administer CT in half of the patients.

Creation of a standardized set of patient-centered outcomes for advanced prostate cancer: An international effort.

282 Background: Clinical trials and international registries assess outcomes considered relevant to men with advanced prostate cancer (CaP). However, we lack a single standardized set of outcomes, making direct comparisons between populations and quality of care assessments challenging. We sought to create a minimum standardized set of outcomes relevant to men with advanced CaP. Methods: The International Consortium for Health Outcomes Measurement assembled a multi-disciplinary working group to create a minimum set of measures to collect for men with advanced CaP. We used a modified Delphi method to establish pertinent measures and case-mix characteristics. Results: Approximately 24 experts, including clinicians and patient advocates, from North America, Europe, and Australia participated. We defined the included population as men with metastatic prostate cancer or biochemical recurrence who failed or were ineligible for salvage therapy. Outcomes important to all men with advanced CaP, such as overall sur...

Abstract P3-07-18: The NABON breast cancer audit; quality improvement in three years' time

Background The lifetime risk of developing breast cancer is 1 in 8 for women in the Netherlands. Breast cancer care in the Netherlands is of high quality, resulting in low 5-year local recurrence rates of 1.5% after breast conserving therapy and 2.7% after mastectomy. Although good endpoints of breast cancer treatment are obtained, it is expected that further improvement of care can be achieved since unexplained variation in a number of treatment aspects was found between hospitals in the Netherlands. Clinical audits provide an important tool for quality assessment. Worldwide, only a few nationwide clinical audits for breast cancer care are currently running. In the Netherlands, a nationwide multidisciplinary clinical audit started three years ago. Material and methods The multidisciplinary national NABON Breast Cancer Audit (NBCA) started collecting data of all Dutch hospitals in 2011, facilitated by Comprehensive Cancer Centre the Netherlands (IKNL) and Dutch Institute for Clinical Auditing (DICA). The NBCA has several purposes: nation-wide evaluation of quality parameters, evaluation of guideline adherence, and providing weekly updated feedback to participating institutions. Results All Dutch hospitals (n=92) participate by providing data regarding delivered breast cancer care resulting in a database of more than 42.000 breast cancer patients (5.745 DCIS and 36.396 invasive carcinomas) in three years time. Eighty-nine percent of invasive breast cancer patients were treated with primary surgery of which 62% (n=19.885) with breast conserving surgery. Within three years time, several quality assessments improved such as guideline compliance for pre- and postoperative multidisciplinary team meetings, percentage of patients starting surgery within five weeks (see table). The percentage of patients that were treated with preoperative systemic treatment (12%; 95% CI: 0 – 47%) and patients receiving an immediate reconstruction after ablative surgery (19%; 95% CI 0 – 73%) still remained low with a large variation between hospitals. At the conference, results will be substantiated by funnelplots. Other quality indicators will be presented as well. Conclusions The continuous cycle of registration and providing feedback by clinical auditing provides a powerful tool for quality monitoring and improving breast cancer care. Improvements of monodisciplinairy surgical and pathological aspects of care have been reached in a relatively short time period. However, for more complicated multidisciplinary issues like the use of primary systemic treatment and immediate reconstruction, detailed analyses of the variation between hospitals is needed to further improve these aspects of breast cancer care. Citation Format: Annelotte C van Bommel, Marie-Jeanne T Baas-Vrancken Peeters, Margriet van der Heiden - van der Loo, Thijs van Dalen, Emiel J Rutgers, Michel W Wouters, Marc B Lobbes, Ruud M Pijnappel, Marc A Mureau, Pieter J Westenend, Bart de Vries, Carolien H Smorenburg, Agnes Jager, John H Maduro, Henk Struikmans, Carol Richel, Marga Schrieks, Maike Schepens, Sabine Siesling, Vivianne C Tjan-Heijnen. The NABON breast cancer audit; quality improvement in three years9 time [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-07-18.

Abstract P2-11-03: Multidisciplinary breast cancer care registry and quality control system in the Netherlands: The NABON breast cancer audit

Background Previous quality assessments in oncology focused on surgical issues such as number of annual operations per hospital. However, high-quality of care depends on an excellent interplay between all disciplines involved in cancer care. The NABON (National Breast Cancer Organisation of the Netherlands) has, therefore, developed a multidisciplinary set of 30 quality indicators to check and improve breast cancer care. Health insurers have recently decided to use this information for purchasing. Methods The NABON Breast Cancer Audit (NBCA) started in 2011. Data on all newly diagnosed patients with invasive breast cancer in the Netherlands are collected by the Netherlands Cancer Registry (n=61 hospitals) or by the physicians themselves (n=31 hospitals). Data capture is facilitated using a web-based portal and feedback to participating hospitals on their own data is being done every week. Since 2012 all Dutch hospitals participate. A set of quality indicators on process and outcome was selected following established clinical guidelines and is being supervised by a multidisciplinary steering committee. Results Data of all 41,958 breast cancer patients treated between 2011 and 2013 were collected. In 2013, 94% of patients were discussed in the multidisciplinary team prior to first treatment and 98% after surgery. BI-RADS score was used in 98% of radiological reports. After neo-adjuvant chemotherapy, 7.6% of patients had positive specimen margins following first breast conserving surgery compared to 5.0% and 20% of patients following primary breast conserving surgery for invasive cancer and ductal carcinoma in situ, respectively. Eighteen percent and 36% of patients underwent immediate breast reconstruction after mastectomy for invasive cancer and ductal carcinoma in situ, respectively. Pathological analysis showed 12% of patients had HER2 positive and 85% had ER positive disease. Neo-adjuvant or adjuvant systemic therapy was given to 63% of patients and neo-adjuvant or adjuvant chemotherapy to 39% of patients. Time between diagnosis and first treatment was generally short: 49% to 85% underwent primary surgery with and without immediate reconstruction, respectively, and 76% underwent neo-adjuvant chemotherapy within 5 weeks from first biopsy. At the conference we will show that variation between hospitals was not related to annual surgical volume per hospital. Conclusion The NBCA is a unique national system to provide and confirm quality assessment in breast cancer and to drive improvements in quality of multidisciplinary breast cancer care. Present results show an overall high quality of care in the Netherlands and provide insight in items of improvement. Citation Format: Vivianne C Tjan-Heijnen, Annelotte C van Bommel, Margriet van der Heiden-van der Loo, Pieter Westenend, Bart de Vries, Carolien H Smorenburg, Agnes Jager, Marc B Lobbes, Ruud M Pijnappel, John H Maduro, Henk Struikmans, Marc A Mureau, Marga Schrieks, Carol Richel, Maike Schepens, Thijs van Dalen, Michel W Wouters, Marie-Jeanne T Vrancken Peeters, Emiel J Rutgers, Sabine Siesling. Multidisciplinary breast cancer care registry and quality control system in the Netherlands: The NABON breast cancer audit [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-11-03.

Abstract P6-08-01: Contemporary risk of local, regional and contralateral breast cancer recurrence

Background Long-term follow-up of breast cancer patients aims to detect curable recurrence, and focuses on ipsilateral in-breast recurrence (LR), regional lymph node recurrence (RR) and contralateral breast cancer (CBC). In recent years there is mounting evidence of a decrease in locoregional recurrence rates. Non-surgical-treatment modalities have evolved extensively, while surgery has become less invasive over the last fifteen years. The present study aimed to address contemporary loco-regional recurrence rates evaluating time trends and the role of contributing factors. Material and methods The Netherlands Cancer Registry was searched for all female patients diagnosed and operated for a unilateral primary breast cancer (pT1-2,anyN,M0) between 1-1-2003 and 31-12-2006. Exclusion criteria were previous cancer, neo-adjuvant chemotherapy or incurable disease. Data on 5-year follow-up were available from hospital records and included the first site of recurrence and contralateral breast cancer (CBC). The 5-year risk of developing LR, RR and CBC were estimated using Kaplan Meier curves. Patients were censored at time of death, lost to follow-up or the development of distant metastases. Prognostic influence of various patient- and disease characteristics was assessed. Results A total of 35.006 eligible patients were identified. The 5-year rates of LR, RR, and CBC are presented in Table 1. The risk of CBC was higher than LR and RR. Over time, the rates decreased significantly for all three endpoints. The LR-rate was lower with breast conserving surgery (BCS) vs. amputation (1.8% vs. 2.5%), T1a-b vs. T1c-T2 tumors (2.0% vs. 2.5%), ER+ vs. ER- tumors (1.8% vs. 3.5%) and inversely related with age (highest in pts. The 5-year RR-rate was 0.9% for N0 patients, and decreased from 1.0% to 0.7% over time. The risk of RR after amputation decreased from 1.8% to 0.9% over time, but was higher than after BCS (1.6% vs. 0.6%). Overall, the RR-rate was highest in the N>1 group (1.4%) and the triple negative group (2.0%). The CBC-rate was lower for patients who received chemotherapy (CT) than for patients who did not (1.6% vs. 3.1%). The CBC-rate only decreased over the years in the CT-group (3.7% to 2.5%). Conclusions Loco-regional recurrence rates have decreased substantially in recent years and have become very low. For the vast majority of patients the risk of LR is substantially lower than the risk of CBC and the risk of RR is rarely larger than 1.0%. These low rates might reflect improvements in systemic treatment. Citation Format: Kim C Aalders, Annelotte CM van Bommel, Thijs van Dalen, Gabe S Sonke, Paul J van Diest, Liesbeth J Boersma, Margriet van der Heiden-van der Loo. Contemporary risk of local, regional and contralateral breast cancer recurrence [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P6-08-01.