It is possible – establishing a web based system in

1It

is possible – establishing a web based system in a major German

2university

hospital to successfully measure patient reported

3outcomes

using the ICHOM data set

4Karsten Maria Margarete1, Kirchberger Valerie2, Hartmann Claudia2, Zeuschner Nele1, 5Lippold Kai2, Kiver Verena, Speiser Dorothee1, Tiedemann Marc3, Blohmer Jens Uwe1 61 Klinik für Gynäkologie mit Brustzentrum, Charité Universitätsmedizin Berlin 72 ?? 83 Heartbeat Medical

9Keywords 10 11Abstract 12Background: 13Collecting patient reported outcome (PRO) data in a systematic way enables an objective 14evaluation of treatments and its related outcomes. By using the disease specific 15questionnaires developed by the International Consortium of Health Outcome Measurement 16(ICHOM) this allows for comparison between physicians, hospitals and even different 17countries. 18Objective: 19 20 21Methods: 22In November 2016 we implemented a web-based system to collect PRO data at the breast 23center at Charité University hospital using the ICHOM data set. All new patients who are 24seen at the breast center are enrolled and are answering a predefined set of questions using 25a tablet computer. Once they start their treatment at Charité automated emails are sent to the 26patient at predefined treatment points. Those emails contain a web-based link through which 27they can access their questionnaires. 28Results 29Until now we have enrolled 834 patients and initiated 2470 questionnaires. 9.44% of patients 30were under 40 years of age, 49.7% between 40 and 60, 39.6% between 60-80 and 1.3% 31over the age of 80 years. The average return rate of questionaires is 72% without any 32additional intervention. When asked about preference regarding paper versus online 7.9% of 33the patients 50 to 60 years of age would prefer paper, 18% in the 60-70 years of age group 34and 21.2 % in the age group over 70 years. 35Conclusion 36Measuring PRO in breast cancer patients in an automated electronic version is possible 37across all age ranges while simultaneously achieving a high return rate.

38Introduction 39Every year 70 000 women will receive a new diagnosis of breast cancer in Germany and 40almost thirty percent of them are under the age of fifty-five. Due to improved screening and 41treatment modalities there has been a significant improvement in overall survival in the last 42decade(Carioli et al., 2018, Bergh et al., 2001, Coleman et al., 2008). Breast cancer specific 43mortality in Europe was reduced from 17.9 per one hundred thousand women in 2002 to 15.2 44women in 2012(Carioli et al., 2017). Those survival gains however are often associated with 45a loss in physical functioning, increased morbidity and new challenges regarding the 46emotional, social and financial aspects of life(Seabury et al., 2017, Spathis et al., 2015, 47Capelan et al., 2017, Lambert et al., 2012). This increase in life expectancy for cancer 48patients is leading to increased scrutiny regarding the long term side effects of new and 49existing cancer treatments (Jain et al., 2017, Byun et al., 2017). An important aspect in 50evaluating the effects of any therapy, but especially so in the setting of cancer, is the patients 51voice and perception. The best way to capture this is by using patient reported outcome 52measures (PRO). The US Food and Drug Agency describes PRO as “any report coming 53directly from patients about a health condition and its treatment” (Chen et al., 2013). Using 54electronic media like smartphone and tablet computers measuring PRO data is now much 55easier and less time and cost consuming than in the past. This allows for a real time 56evaluation of therapy concepts, the monitoring of new treatments as well as an easy way for 57long term follow up. Increasingly complex therapies in medicine are simultaneously requiring 58an increase in documentation - time that is taken away from the already limited time 59physicans and nurses have to spend with their patients(Tai-Seale et al., 2017, Joukes et al., 602018). This time however is needed to adequately assess a patient´s situation and 61symptoms. PRO has been shown in multiple studies to help the clinician to adequately 62assess patient symptoms and therefore improve patient care and even survival(Basch et al., 632009, Basch et al., 2016). 64 65Methods 66After obtaining ethics approval from the Charité ethics commission we implemented a web 67based system to measure PRO at the Charité Breast Center starting in November 2016. We 68chose the questionnaire set for breast cancer which was developed by the International 69Counsil on Health Outcome Measurement (ICHOM) for content. The plan was to include all 70new patients who were seen at the breast clinic into the PRO measurement and then to 71stratify only those into follow up who had a diagnosis of breast cancer and received their 72treatment at Charité Breast Center. There was one universal log in code for all staff members 73as well as individual ones for the physicians working at the Breast Center. After the patients

74registered at the clinic they were asked by the receptionist if they would be willing to 75participate and received a personal log in after they signed consent. The waiting time until 76their appointment was used to answer the ICHOM questions as well as questions regarding 77their medical history on a tablet computer. After successful completion of the questionnaire 78the content was immediately online available for their physician. The treating physicians than 79had the option to enter clinical data into the software used to collect the PRO data. If they 80decided not to do that, the clinical data necessary was later entered by support staff. Once 81patients entered specific care pathways like chemotherapy or surgery an automated process 82was started through which they received follow up emails containing the access code to their 83individuell PRO measurement questionnaire. 84 85Results 86Monthly Increase in patient numbers with PRO measurement since implementation 87

88 89 90Increase in patients with pro measurement compared to total number of new patients 91seen at the breast center Nov 16 Dez 16 Jan 17 Feb 17 Mrz 17 Apr 17 Mai 17 Jun 17 Jul 17

105 90 116 124 166 104 139 112 116

13 7 40 10 4 20 25 9 55

12% 8% 34% 8% 2% 19% 18% 8% 47%

Aug 17 Sep 17 Okt 17 Nov 17 Dez 17

108 163 93 169 117

54 67 59 115 86

92 93 94 95 96 97 98Willingness to enter into follow up across all ages

99 100Using a digital way to measure PRO compared to a paper based version is preferred in 101almost all age groups 102Return rates regarding follow up 103Marc 104 105Discussion 106

50% 41% 63% 68% 74%

107Principal Results 108 109 110 111 112 113 114Limitations 115 116 117 118 119Comparison with Prior Work 120 121 122 123 124 125Conclusions 126The goal of this pilot trial was to create a template on how to establish a successful web 127based PRO measurement at a german hospital, identifying pitfalls as well as necessary 128requirements. 129 130Acknowledgements 131Please include all authors’ contributions, funding information, financial disclosure, role of sponsors, 132and other acknowledgements here. This description should include the involvement, if any, in review 133and approval of the manuscript for publication and the role of sponsors. Omit if not applicable. 134

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