Science

Scientific sources for the medical content and procedures in our medidux™ DiGA

The following sources were used for the medical content and procedures in our DiGA:

• Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830.
  
  
• Basch E, Dueck AC. Patient-reported outcome measurement in drug discovery: a tool to improve accuracy and completeness of efficacy and safety data. Expert Opin Drug Discov. 2016 Aug;11(8):753-8. doi: 10.1080/17460441.2016.1193148. Epub 2016 Jun 16. PMID: 27310432.
  
  
• Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156. PMID: 28586821; PMCID: PMC5817466.
  
  
• Basch E. Patient-reported outcomes: an essential component of oncology drug development and regulatory review. Lancet Oncol. 2018 May;19(5):595-597. doi: 10.1016/S1470-2045(18)30141-4. PMID: 29726373.
  
  
• Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of Patient-Reported Outcomes in Routine Medical Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:122-134. doi: 10.1200/EDBK_200383. PMID: 30231381.
  
  
• Basch E. High Compliance Rates With Patient-Reported Outcomes in Oncology Trials Submitted to the US Food and Drug Administration. J Natl Cancer Inst. 2019 May 1;111(5):437-439. doi: 10.1093/jnci/djy183. PMID: 30561701.
  
  
• Bennett AV, Dueck AC, Mitchell SA, Mendoza TR, Reeve BB, Atkinson TM, Castro KM, Denicoff A, Rogak LJ, Harness JK, Bearden JD, Bryant D, Siegel RD, Schrag D, Basch E; National Cancer Institute PRO-CTCAE Study Group. Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Health Qual Life Outcomes. 2016 Feb 19;14:24. doi: 10.1186/s12955-016-0426-6. PMID: 26892667; PMCID: PMC4759776.
  
  
• Chung A E, Shoenbill K, Mitchell S A, Dueck A C, Schrag D, Bruner D W, Minasian L M, St. Germain D, O’Mara A M, Baumgartner P, Rogak L J, Abernethy A P, Griffin A C, Basch E M, Patient free text reporting of symptomatic adverse events in cancer clinical research using the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), Journal of the American Medical Informatics Association, Volume 26, Issue 4, April 2019, Pages 276 285, https://doi.org/10.1093/jamia/ocy169
  
  
• Denis F, Lethrosne C, Pourel N, Molinier O, Pointreau Y, Domont J, Bourgeois H, Senellart H, Trémolières P, Lizée T, Bennouna J, Urban T, El Khouri C, Charron A, Septans AL, Balavoine M, Landry S, Solal-Céligny P, Letellier C. Randomized Trial Comparing a Web-Mediated Follow-up With Routine Surveillance in Lung Cancer Patients. J Natl Cancer Inst. 2017 Sep 1;109(9). doi: 10.1093/jnci/djx029. Erratum in: J Natl Cancer Inst. 2018 Apr 1;110(4):436. PMID: 28423407.
  
  
• Denis F, Basch E, Septans AL, Bennouna J, Urban T, Dueck AC, Letellier C. Two-Year Survival Comparing Web-Based Symptom Monitoring vs Routine Surveillance Following Treatment for Lung Cancer. JAMA. 2019 Jan 22;321(3):306-307. doi: 10.1001/jama.2018.18085. PMID: 30667494; PMCID: PMC6439676.
  
  
• Detmar SB, Muller MJ, Schornagel JH, Wever LD, Aaronson NK. Health-related quality-of-life assessments and patient-physician communication: a randomized controlled trial. JAMA. 2002 Dec 18;288(23):3027-34. doi: 10.1001/jama.288.23.3027. Erratum in: JAMA. 2003 Feb 26;289(8):987. PMID: 12479768.
  
  
• Egbring M, Far E, Roos M, Dietrich M, Brauchbar M, Kullak-Ublick GA, Trojan A. A Mobile App to Stabilize Daily Functional Activity of Breast Cancer Patients in Collaboration With the Physician: A Randomized Controlled Clinical Trial. J Med Internet Res. 2016 Sep 6;18(9):e238. doi: 10.2196/jmir.6414. PMID: 27601354; PMCID: PMC5030453
  
  
• Iivanainen S, Alanko T, Peltola K, Konkola T, Ekström J, Virtanen H, Koivunen JP. ePROs in the follow-up of cancer patients treated with immune checkpoint inhibitors: a retrospective study. J Cancer Res Clin Oncol. 2019 Mar;145(3):765-774. doi: 10.1007/s00432-018-02835-6. Epub 2019 Jan 21. PMID: 30666409; PMCID: PMC6394667.
  
  
• Kaur G, Kyte D, Reeve BB, Basch E, Calvert M. Patient-reported outcome monitoring in a routine paediatric oncology setting: challenges and opportunities. Lancet Oncol. 2019 Jan;20(1):19-20. doi: 10.1016/S1470-2045(18)30785-X. PMID: 30614459.
  
  
• Margulies A, Kroner T, Gaisser A, Bachmann-Mettler I. Onkologische Krankenpflege. 6. Edition. Springer Berlin, Heidelberg. 2017 June 09. doi: 10.1007/978-3-662-53955-2.
  
  
• Peltola MK, Lehikoinen JS, Sippola LT, Saarilahti K, Mäkitie AA. A Novel Digital Patient-Reported Outcome Platform for Head and Neck Oncology Patients-A Pilot Study. Clin Med Insights Ear Nose Throat. 2016 Sep 27;9:1-6. doi: 10.4137/CMENT.S40219. PMID: 27721662; PMCID: PMC5040424.
  
  
• Pircher M, Winder T, Trojan A. Response to vemurafenib in metastatic triple-negative breast cancer harbouring a BRAF V600E mutation: a case report and electronically captured patient-reported outcome. Case Rep Oncology. 2021, Feb
  
  
• O.O. Schmalz, C. Jacob, J. Ammann, B. Liss, S. Iivanainen, M. Kammermann, J. Koivunen, M. Giger, A. Klein, R.A. Popescu, 85P – Impact of digital patient monitoring (DPM) on quality of clinical care of cancer immunotherapy (CIT)-treated patients (pts) with advanced/metastatic non-small cell lung cancer (a/mNSCLC), Annals of Oncology, Volume 30, Supplement 11, 2019, Pages xi30-xi31,ISSN 0923-7534, https://doi.org/10.1093/annonc/mdz449.039.
  
  
• Seow H, Sussman J, Martelli-Reid L, Pond G, Bainbridge D. Do high symptom scores trigger clinical actions? An audit after implementing electronic symptom screening. J Oncol Pract. 2012 Nov;8(6):e142-8. doi: 10.1200/JOP.2011.000525. Epub 2012 Aug 21. PMID: 23598849; PMCID: PMC3500488.
  
  
• Trojan A, Bättig B, Mannhart M, Seifert B, Brauchbar MN, Egbring M. Effect of Collaborative Review of Electronic Patient-Reported Outcomes for Shared Reporting in Breast Cancer Patients: Descriptive Comparative Study. JMIR Cancer 2021;7(1):e26950. doi: 10.2196/26950. PMID: 33729162. PMCID: 8088839
  
  
• Trojan A, Leuthold N, Thomssen C, Rody A, Winder T, Jakob A, Egger C, Held U, Jackisch CJ. The Effect of Collaborative Reviews of Electronic Patient-Reported Outcomes on the Congruence of Patient and Clinician-Reported Toxicity in Cancer Patients Receiving Systemic Therapy: Prospective, Multicenter, Observational Clinical Trial. Med Internet Res. 2021 Aug 5;23(8):e29271. doi: 10.2196/29271.
  
  
• Velikova G, Booth L, Smith AB, Brown PM, Lynch P, Brown JM, Selby PJ. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J Clin Oncol. 2004 Feb 15;22(4):714-24. doi: 10.1200/JCO.2004.06.078. PMID: 14966096.
  
  
• National Cancer Institute. Common Terminology Criteria for Adverse Events v.4.0 (CTCAE). Available at: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed March 8th, 2017.

Selection of current studies using our DiGA:

• OGIPRO (NCT5234021)
• CARTePRO (NCT05354973)
• PRO2 (NCT05425550)
• ECOVAR (NCT05352217)
• SwissCanOn (BASEC-Nr. 2021-02519)
• PRO (NCT03578731)