Assessment of Clinical Utility in Decision Curve Analysis for an Individualized Risk Prediction Model of Endometrial Cancer

Öz

Background: There is a need for a personalized risk assessment method (IRPM) for women with abnormal uterine bleeding. Management of abnormal vaginal bleeding is based on diagnostic test results with positive/negative predictive values for a cut-off value. Patient has no contribution on the threshold to act for biopsy or not. Aim of present study was to develop a calibrated model with discriminative ability in which the patient can contribute to decision process. Methods: A cross-sectional one-gate design cohort study was planned to extract data of patients older than 35 years-old. All had index test (endometrial thickness measurement) and reference test (D&C under general anesthesia). Target was histopathological report according to WHO 2014 as benign or pre/cancer. Primary outcome was to develop a useful clinical IRPM and to compare net benefit of IRPM and models mimicking current guidelines for various thresholds of disease in decision curve analysis. Secondary outcomes were to analyse discriminative properties, the number of unnecessary biopsies and missed cases at various thresholds. Findings: IRPM consisting of symptom status, endometrial thickness and age was the best risk predicting method for pre-/endometrium cancer. IRPM had a higher net benefit than guidelines and to biopsy all or not at entire range of clinical threshold probabilities. IRPM had a good discrimination slope and can also decrease number of missed cases. Models mimicking current guidelines were only useful above a threshold of 3% and below this threshold, it is found to be harmful. Interpretation: IRPM doesn't need any additional costs or time-consuming analysis. IRPM may aid patient to contribute to decision of further investigation. Clinical usefulness of IRPM is superior to models mimicking current practice. Value of diagnostic discriminatory cut-offs of guidelines is lower than expected in a heterogenous group of patients. Funding: No funding

Anahtar Kelimeler

• Endometrial Cancer
• Risk Prediction
• Decision Curve Analysis

Endometrium Kanserinde Bireyselleştirilmiş Risk Tahmin Modelinin Karar Eğrisi Analizinde Klinik Kullanılabilirliğinin Değerlendirilmesi

Öz

Endometrium Kanserinde Bireyselleştirilmiş Risk Tahmin Modelinin Karar Eğrisi Analizinde Klinik Kullanılabilirliğinin Değerlendirilmesi Özet Giriş: Anormal uterin kanaması olan kadınlar için bireyselleştirilmiş bir risk değerlendirme yöntemine (IRPM) ihtiyaç vardır. Anormal vajinal kanamanın yönetimi, pozitif/negatif prediktif değerlere sahip tanısal test sonuçlarına dayanır. Bunun hastada biyopsi için harekete geçip geçmeme eşiğinde katkısı yoktur. Bu çalışmanın amacı, hastanın karar sürecine katkıda bulunabilecek, ayırt etme yeteneğine sahip kalibre edilmiş bir model geliştirmektir. Yöntem: Bu çalışma 35 yaşından büyük hastaların verilerini çıkarmak için kesitsel one gate bir kohort çalışması olarak planlanmıştır. Tüm hastalara indeks testi (endometriyal kalınlık ölçümü) ve referans testi (genel anestezi altında D&C) uygulanmış, WHO 2014'e göre bening veya premalign olarak histopatolojik raporlar ayrılmıştır. Birincil amaç, yararlı bir klinik IRPM geliştirmek ve IRPM'nin net faydasını ve karar eğrisi analizinde çeşitli hastalık eşikleri için mevcut kılavuzları taklit eden modelleri karşılaştırmaktır. İkincil amaç ise, ayırt edici özellikleri, gereksiz biyopsilerin sayısını ve çeşitli eşiklerde kaçırılan vakaları analiz etmektir. Bulgular: Semptom durumu, endometriyal kalınlık ve yaştan oluşan IRPM, pre-/endometrium kanseri için en iyi risk öngörme yöntemi olarak bulunmuştur. IRPM, klinik eşik olasılıklarının tüm aralığından biyopsi alma veya almama konusunda yönergelerden daha yüksek bir net faydaya sahiptir. IRPM gözden kaçan vakaların sayısını da azaltabilir. Mevcut yönergeleri taklit eden modellerin yalnızca %3'lük bir eşiğin üzerinde faydalı olduğu ve bu eşiğin altında zararlı olabileceği bulunmuştur. IRPM herhangi bir ek maliyete veya zaman alıcı analize ihtiyaç duymamaktadır. Sonuç: IRPM herhangi bir ek maliyete veya zaman alıcı analize ihtiyaç duymaz. IRPM, hastanın daha ileri inceleme kararına katkıda bulunmasına yardımcı olabilir. IRPM'nin klinik kullanışlılığı, mevcut uygulamayı taklit eden modellerden daha üstündür. Heterojen bir hasta grubunda kılavuzların tanısal ayrımcı kesme değerleri beklenenden daha düşüktür. Finansman: Finansman yok

Anahtar Kelimeler

• Karar Eğrisi Analizi
• Endometrium Kanseri
• Bireyselleştirilmiş Risk Tahmin Modeli

Kaynakça

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