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Zusammenfassung Zielsetzung: Untersuchung der Dokumentationsqualit?t in der f?r alle deutschen Krankenh?user verpflichtenden externen station?ren Qualit?tssicherung nach ??136 SGBV (ESQS). Methodik: Analyse der Vollz?hligkeit der Teilnahme der Krankenh?user und der gelieferten Datens?tze sowie der Richtigkeit der ?bermittelten Daten auf der Grundlage der ESQS-Bundesauswertungen und der Berichte zur Datenvalidierung 2010???2014. Ergebnisse: Die Vollz?hligkeit der teilnehmenden Krankenh?user und der gelieferten Datens?tze hat sich seit 2010 kontinuierlich verbessert und liegt nahe 100?%. Ein Abgleich der Dokumentation f?r die Qualit?tssicherung mit Eintr?gen in 9266 Patientenakten f?r 339 Datenfelder im Rahmen der systematischen Datenvalidierung 2010???2014 zeigte f?r 31,9?% der gepr?ften Datenfelder Verbesserungsbedarf. Von direkt indikatorenrelevanten unerw?nschten Ereignissen (au?er Todesf?llen) wurden 33,2?% f?lschlich nicht f?r die Qualit?tssicherung dokumentiert, bei Todesf?llen liegt diese Unterdokumentation bei 3,5?%. Direkt indikatorenrelevante unerw?nschte Ereignisse (Komplikationen) wurden h?ufiger unterdokumentiert als ?berdokumentiert, bei indikatorenrelevanten erw?nschten Ereignissen ist das Verh?ltnis umgekehrt. Allerdings dokumentieren Krankenh?user in relevantem Ausma? auch zu ihrem Nachteil fehlerhaft. Schlussfolgerung: Es sind eine hohe Vollz?hligkeit der Datenlieferung, jedoch auch relevante Dokumentationsm?ngel in der externen station?ren Qualit?tssicherung festzustellen. Aufgrund der Dokumentationsfehler erscheinen Krankenhausergebnisse h?ufiger ?falsch positiv? als ?falsch negativ?. Missverst?ndnisse und Nachl?ssigkeit scheinen relevante Ursachen der Dokumentationsfehler darzustellen. Es sollten insbesondere angesichts der geplanten Einbeziehung von Daten der ESQS in eine qualit?tsorientierte Versorgungssteuerung geeignete Ma?nahmen eingeleitet werden, um die Qualit?t dieser Daten zu verbessern.

The use of dietary supplements is common in the general population and even more prevalent among cancer survivors. The World Cancer Research Fund/American Institute for Cancer Research specifies that dietary supplements should not be used for cancer prevention. Several dietary supplements have potential pharmacokinetic and pharmacodynamic interactions that may change their clinical efficacy or potentiate adverse effects of the adjuvant endocrine therapy prescribed for breast cancer treatment. This analysis examined the prevalence of self-reported dietary supplement use and the potential interactions with tamoxifen and aromatase inhibitors (AIs) among breast cancer survivors enrolled in three randomized controlled trials of lifestyle interventions conducted between 2010 and 2017. The potential interactions with tamoxifen and AIs were identified using the Natural Medicine Database. Among 475 breast cancer survivors (2.9 (mean) or 2.5 (standard deviation) years from diagnosis), 393 (83%) reported using dietary supplements. A total of 108 different types of dietary supplements were reported and 36 potential adverse interactions with tamoxifen or AIs were identified. Among the 353 women taking tamoxifen or AIs, 38% were taking dietary supplements with a potential risk of interactions. We observed a high prevalence of dietary supplement use among breast cancer survivors and the potential for adverse interactions between the prescribed endocrine therapy and dietary supplements was common.

Background: Dietary supplements (DS), defined as herbal preparations, vitamins and minerals (DSHEA Act 1994), are used by 70% of cancer survivors. The World Cancer Research Fund/American Institute for Cancer Research 2018 Cancer Prevention Recommendations specify not to use DS to protect against cancer. There is some evidence that DS are linked to harmful outcomes, including increased mortality and breast cancer recurrence. DS have potential pharmacokinetic interactions via cytochrome P450 enzyme and pharmacodynamic interactions via estrogenic or hepatotoxic activity, which may increase or reduce clinical efficacy or potentiate adverse effects of Tamoxifen and Aromatase Inhibitors (AIs). This analysis examines baseline usage of DS and potential interactions with Tamoxifen and AIs among breast cancer survivors enrolled in the Lifestyle, Exercise, and Nutrition (LEAN) study, a randomized healthy eating and exercise lifestyle intervention. Methods: We examined the use of DS in 151 breast cancer survivors enrolled in the LEAN Study. Women with a body mass index (BMI) ≥ 25 kg/m 2 were randomly assigned to a 6-month healthy eating and exercise lifestyle intervention (n=93) or to usual care (n=58). At baseline and 6 months, we asked participants to self-report regular DS use, defined as at least 3 times a week for at least one month. The intervention group received evaluation and counseling of DS use by a Registered Dietitian (RD) with a Certified Specialty in Oncology Nutrition (CSO). Potential interactions of moderate and major ratings between DS with Tamoxifen and AIs (Letrozole, Exemestane and Anastrozole) were identified through the Natural Medicines Database by both a pharmacist specializing in oncology and a RD, CSO. Results: Out of 151 women, at baseline 120 (80%) reported using DS. Fifty-four different formulations were enumerated. The majority of women (72, 60%) were taking ≥ 3 formulations. One quarter of women (29, 24%) were taking ≥ 5 formulations (range = 1 - 20). Of the 54 formulations, 33% had potential interactions with Tamoxifen and/or AIs according to the Natural Medicines Database. Total interactions by medication were: 18 Tamoxifen, 14 Letrozole, 14 Exemestane, 9 Anastrozole. The majority of these interactions (87%) were associated with herbal preparations. Conclusions: Our findings are indicative of the high prevalence of DS use among breast cancer survivors and the potential risk of interactions with prescribed hormonal therapy. More research is needed to test if counseling from a RD, CSO can reduce DS use and ultimately lead to better outcomes due to fewer interactions with breast cancer treatments. Citation Format: ThaiHien Nguyen, Maura Harrigan, Courtney Mcgowan, Annette Hood, Fangyong Li, Brenda Cartmel, Leah Ferrucci, Melinda L Irwin, Tara Sanft. Dietary supplement use in a healthy eating and exercise lifestyle intervention in breast cancer survivors: The lifestyle exercise and nutrition (LEAN) study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS8-09.

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