Do pre-operative radiologic assessment predict postoperative outcomes in patients with insertional Achilles tendinopathy?: a retrospective database study

INTRODUCTION Diagnosis and treatment of insertional tendinopathy of the Achilles tendon (IAT) remains a challenge. The aim of this study was to assess the influence of pre-operative radiological pathologies on the patient-reported outcomes following open debridement of all pathologies for IAT. MATERIALS AND METHODS In this IRB-approved retrospective correlation and comparative study, patients with pre-operative imaging were identified from the authors' retrospective IAT database comprising of 118 patients. All were treated by a standardized surgical treatment strategy utilizing a midline, transachillary approach and debridement of all pathologies. A total of fifteen radiologic parameters were measured on radiographs (RX) and MRI. The patient-reported outcomes were assessed using the Victorian Institute of Sport Assessment-Achilles questionnaire (VISA-A-G) and the general health questionnaire SF-12 at a minimum follow-up of 12~months. The data are presented as mean ± SD (95% CI). RESULTS 88 patients (74.6%) with an average age of 50 ± 12 (47-52) years were included. Radiographs were available in 68 patients and MRI in 53. The mean follow-up was 3.8 ± 1.9 (3.4-4.3) years. The overall VISA-A-G was 81 ± 22 (77-86), the SF-12 PCS 54 ± 7 (52-55), and the SF-12 MCS 52 ± 9 (50-54) points. None of the assessed radiological parameters had a significant influence on the patient-reported outcome following surgical treatment for IAT. CONCLUSION In this retrospective correlation study, no significant association was found between preoperative radiographic and MRI radiologic parameters for IAT and postoperative patient-reported outcomes (VISA-A-G and SF-12)

Schmerztherapie bei Darmkrebspatienten: Längsschnittanalysen auf Versichertendaten basierend

BACKGROUND: The adequate treatment of pain is an important component in the care of cancer patients. To date, no study has systematically investigated the use of analgesics and adjuvant pain medication for cancer patients. OBJECTIVE: Quantification of the use of analgesics and adjuvant pain medication exemplified by colorectal cancer (CRC) patients in different periods of time before and after cancer diagnosis. MATERIAL AND METHODS: For this study the data from four statutory health insurance providers available in the German pharmacoepidemiological research database (GePaRD) were used. Patients with a first colorectal cancer diagnosis in 2010 were identified via the ICD-10 codes (C18–C20) and observed over 5 years. The percentage of patients receiving opioids, non-opioid analgesics, certain drugs for adjuvant pain medication (antidepressants, the antiepileptics pregabalin and gabapentin) and benzodiazepines during several periods before and after diagnosis (prescription prevalence) were calculated. The most prescribed active ingredient for each drug class was collated and patients were categorized into three groups according to the cancer stage at diagnosis or development of metastases during follow-up. RESULTS: This study included 9596 patients with incident CRC in 2010. Regarding opioids, the prescription prevalence increased from 8% before diagnosis to a maximum of 31% for patients with metastases. Defined daily doses (DDDs) of weak opioids amounted to one third of all prescribed opioid DDDs in patients with advanced CRC or metastases during follow-up and to two thirds of the other patients. Regarding non-opioid analgesics, the prescription prevalence increased from approximately 35% before diagnosis to up to 56% after diagnosis, for antidepressants from approximately 9% to a maximum of 18%, for pregabalin and gabapentin from 2% to a maximum of 9% and for benzodiazepines from 5% to a maximum of 14%. CONCLUSION: Compared to the available literature the results tend to indicate a cautious use of opioids in CRC patients in Germany. The high prescription prevalence of drugs potentially causing severe adverse drug reactions when given concomitantly, emphasizes the importance of considering the risk of drug interactions in these patients.HINTERGRUND: Die adäquate Behandlung von Schmerzen ist ein wichtiger Bestandteil in der Versorgung von Krebspatienten, doch mangelt es bisher an Studien, die den Gebrauch von Schmerzmitteln bzw. adjuvanten Schmerztherapeutika bei Krebspatienten systematisch untersuchen. ZIEL: Die Quantifizierung des Gebrauchs von Schmerzmitteln und adjuvanten Schmerztherapeutika wird am Beispiel von Darmkrebspatienten in verschiedenen Zeiträumen vor und nach Diagnose beschrieben. MATERIAL UND METHODEN: Für die Studie wurde die pharmakoepidemiologische Forschungsdatenbank GePaRD (German Pharmacoepidemiological Research Database) verwendet, die Abrechnungsdaten von 4 gesetzlichen Krankenkassen enthält. Darmkrebspatienten mit Erstdiagnose im Jahr 2010 wurden mittels ICD-Kodes (C18-C20) identifiziert und über 5 Jahre nachbeobachtet. Die Autoren berechneten für verschiedene Zeiträume vor und nach Diagnose jeweils den Anteil an Patienten, die Opioide, nichtopioide Schmerzmittel, bestimmte adjuvante Schmerztherapeutika (Antidepressiva und die Antikonvulsiva Pregabalin und Gabapentin) und Benzodiazepine erhielten (Verordnungsprävalenz) und ermittelten für die Arzneimittelgruppen die am häufigsten verordneten Wirkstoffe. Je nach Schweregrad der Erkrankung bei Diagnose bzw. Metastasenbildung im Verlauf wurde zwischen 3 Patientengruppen unterschieden. ERGEBNISSE: Insgesamt wurden 9596 Patienten mit inzidentem Darmkrebs im Jahr 2010 eingeschlossen. Für Opioide stieg die Verordnungsprävalenz von ~8 % vor Diagnose auf maximal 31 % bei Patienten mit Metastasenbildung. Auf schwach wirksame Opioide entfielen bei Patienten mit fortgeschrittenem Darmkrebs bzw. Metastasenbildung etwa ein Drittel der Tagesdosen, bei den übrigen Patienten zwei Drittel. Die Verordnungsprävalenzen für nichtopioide Schmerzmittel stiegen von ~35 % vor Diagnose auf bis zu 56 % nach Diagnose, für Antidepressiva von ~9 % auf maximal 18 %, für Pregabalin und Gabapentin von 2 % bis maximal 9 % und für Benzodiazepine von 5 % auf maximal 14 %. DISKUSSION: Vergleicht man die Ergebnisse mit der verfügbaren Literatur, könnten diese tendenziell auf einen zurückhaltenden Einsatz von Opioiden bei (Darm‑)Krebspatienten hindeuten. In Anbetracht der hohen Verordnungsprävalenz von Arzneimitteln, deren gleichzeitige Gabe schwerwiegende Konsequenzen haben kann, ist bei dieser Patientengruppe hinsichtlich Arzneimittelinteraktionen besondere Vorsicht geboten

Potential of German claims data to characterize utilization of new cancer drugs: the example of crizotinib

AIMS: Premarketing clinical trials are typically conducted under controlled conditions and in selected study populations, so real-world information on the utilization of new cancer drugs is limited. We aimed to explore the potential of German claims data in this regard, exemplified by the ALK inhibitor crizotinib, used in non-small-cell lung cancer therapy. MATERIALS & METHODS: We identified patients treated with crizotinib in the German Pharmacoepidemiological Research Database (2004–2017; 20% of the German population) and assessed patient characteristics, treatment and survival. RESULTS: We identified 348 crizotinib-treated patients (56% female; 25% first-line users). After 2 years, overall survival was 48%, with higher survival in men than in women (58 vs 40%). Overall, 76% of patients discontinued crizotinib treatment. Of those, 41% received another ALK inhibitor afterward. CONCLUSION: The results underline the potential of German claims data for real-world monitoring of oncological drug utilization

Incidence of advanced colorectal cancer in Germany: comparing claims data and cancer registry data

BACKGROUND: Incidence rates of advanced cancer stages are important, e.g., for monitoring cancer screening programs. However, information from cancer registries on tumor stage is often incomplete. Exemplified by colorectal cancer (CRC), we explored the potential of German claims data to estimate incidence rates of advanced cancer stages. METHODS: We used claims data of the German Pharmacoepidemiological Research Database (GePaRD; information on > 20 million persons) to identify incident patients with advanced CRC based on ICD-10 codes for CRC and secondary malignant neoplasms. We calculated annual age-standardized incidence rates (ASIRs) of advanced CRC per 100,000 for the years 2008–2015 stratified by the presence of affected lymph nodes only (C77) vs. distant metastases (C78-C79) and compared them to ASIRs determined using data (2008–2014) from the German Centre for Cancer Registry Data (ZfKD). RESULTS: In GePaRD, the ASIRs of advanced CRC per 100,000 in 2014 were 21.5 among men and 14.9 among women. Compared to ZfKD data the ASIR in GePaRD was 2.58 lower in men and 0.27 higher in women (per 100,000) in 2014. Stratification by presence of distant metastases showed divergent patterns: the ASIRs regarding distant metastases were ~ 50% (women) and ~ 30% (men) higher, and the ASIRs regarding affected lymph nodes only were ~ 40% lower in GePaRD as compared to ZfKD. CONCLUSION: While ASIRs of advanced CRCs overall agreed well between claims and cancer registry data in 2014, the analyses stratified by presence of distant metastases showed differences. Cancer registries might underestimate ASIRs of CRCs with distant metastases

Characteristics and Absolute Survival of Metastatic Colorectal Cancer Patients Treated With Biologics: A Real-World Data Analysis From Three European Countries

Introduction: Biologics were approved for the treatment of advanced colorectal cancer (CRC) based on favorable benefit-risk-assessments from randomized controlled trials (RCTs), but evidence on their use in the real-world setting is scarce. Based on descriptive analyses we therefore aimed to assess characteristics and survival of CRC patients treated with biologics using large healthcare databases from three European countries (Netherlands, Italy, Germany). Methods: We included CRC patients treated with a biologic in 2010 or 2014 and characterized them regarding age, sex, comorbidities, and absolute survival. Results: Among 4,758 patients, the mean age ranged from 64.8 to 66.8 years, the majority was male, and comorbidities used as exclusion criteria in RCTs were coded in up to 30% of these patients. The proportion of bevacizumab users decreased between 2010 (72\u201393%) and 2014 (63\u201385%). In 2014, the absolute 12-month survival in new users was 64% (95% CI 51\u201377%), 56% (30\u201380%), and 61% (58\u201363%) in the Dutch, Italian, and German database, respectively, varying by age and comorbidity. Conclusions: Our study suggests that in the real-world setting, CRC patients treated with biologics are older and less selected regarding comorbidities compared to patients in RCTs, potentially explaining the relatively low 12-month survival we found. Treatment decisions in the real-world setting may require careful evaluation given that the risk-benefit ratio may vary depending on age and co-existing conditions