%TTD and %TUDD: New SAS macro programs to calculate the survival data of the time to deterioration for patient-reported outcomes data in oncology.

BACKGROUND AND OBJECTIVE: Longitudinal analysis of patient-reported outcome (PRO) data remains challenging, as no standardization of statistical methods has been proposed, making comparison of PRO results between clinical trials difficult. In this context, the time to deterioration approach has recently been proposed and is regularly used as a modality of longitudinal PRO analysis in oncology. METHODS: Two new SAS macro programs were developed, %TTD and %TUDD, which implement longitudinal analysis of PRO data according to the time to deterioration approach. These programs implement the recommended deterioration definitions. We described the programs with their different functionalities. RESULTS: The %TTD macro calculates the time to first or transient deterioration, and the %TUDD macro calculates the time until definitive deterioration. These macros allow to obtain the survival variables from the time to deterioration approach. We illustrate our programs by presenting different applications on the randomized phase II AFUGEM GERCOR clinical trial. CONCLUSION: The implementation of the deterioration definitions in SAS software allows the dissemination of this approach, in order to move toward the goal of standardization of longitudinal PRO analysis in oncology clinical trials.

Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.

PURPOSE: The time to deterioration (TTD) approach has been proposed as a modality of longitudinal analysis of patient-reported outcomes (PROs) in cancer randomized clinical trials (RCTs). The objective of this study was to perform a systematic review of how the TTD approach has been used in phase III RCTs to analyze longitudinal PRO data. METHODS: A systematic literature search was conducted in PubMed/MEDLINE, the Cochrane Library and through manual search to identify studies published between January 2014 and June 2018. All phase III cancer RCTs including a PRO endpoint using the TTD approach were considered. We collected general information about the study, PRO assessment and the TTD approach, such as the event definition, the choice of reference score and whether the deterioration was definitive or not. RESULTS: A total of 1549 articles were screened, and 39 studies were finally identified as relevant according to predefined criteria. Among these 39 studies, 36 (92.3%) were in advanced and/or metastatic cancer. Several different deterioration definitions were used in RCTs, 10 studies (25.6%) defined the deterioration as "definitive", corresponding to a deterioration maintained over time until the last PRO assessment available for each patient. The baseline score was explicitly stated as the reference score to qualify the deterioration for most studies (n = 31, 79.5%). CONCLUSION: This review highlights the lack of standardization of the TTD approach for the analysis of PRO data in RCTs. Special attention should be paid to the definition of "deterioration", and this should be based on the specific cancer setting.

Coping with a newly diagnosed high-grade glioma: patient-caregiver dyad effects on quality of life.

Patients with high-grade gliomas (HGG) and their caregivers have to confront a very aggressive disease that produces major lifestyle disruptions. There is an interest in studying the ability of patients and their caregivers to cope with the difficulties that affect quality of life (QoL). We examine, in a sample of patient-caregiver dyads in the specific context of newly diagnosed cases of HGG, whether the QoL of patients and caregivers is influenced by the coping processes they and their relatives use from a specific actor-partner interdependence model (APIM). This cross-sectional study involved 42 dyads with patients having recent diagnoses of HGG and assessed in the time-frame between diagnosis and treatment initiation. The self-reported data included QoL (Patient-Generated Index, EORTC QLQ-C30, and CareGiver Oncology QoL), emotional status, and coping strategies (BriefCope). The APIM was used to test the dyadic effects of coping strategies on QoL. Coping strategies, such as social support, avoidance, and problem solving, exhibited evidence of either an actor effect (degree to which the individual's coping strategies are associated with their own QoL) or partner effect (degree to which the individual's coping strategies are associated with the QoL of the other member of the dyad) for patients or caregivers. For positive-thinking coping strategies, actor and partner effect were not observed. This study emphasizes that the QoL for patients and their caregivers was directly related to the coping strategies they used. This finding suggests that targeted interventions should be offered to help patients and their relatives to implement more effective coping strategies.

[Health-related quality of life in patients treated for ovarian cancer: tools and issues]. / Étude de la qualité de vie dans les néoplasies ovariennes : outils et enjeux.

Health-related quality of life (QoL) in patients treated for ovarian cancer is directly and heavily impacted by the natural history of cancer, its evolution and its therapeutic modalities. The evaluation and consideration of various parameters of QoL seems to be a major issue. Indeed, on the one hand, it is essential to take into account the opinion of patients in the choice of therapeutic strategies for this cancer with a poor prognosis and, on the other hand, more and more studies show that QoL is an independent prognostic factor in ovarian cancer. Improvement in this case, in addition to being an endpoint by itself, would potentially improve the overall survival of patients. To date there are several tools to assess QOL of patients with ovarian cancer. The 2 questionnaires most commonly used are: FACT-O and the EORTC QLQ-OV28. The aim of our study was to evaluate from a review of the literature, the reciprocal effects of ovarian cancer on QoL and QoL on ovarian cancer survival, as well as specificities of each of the 2 questionnaires most commonly used in assessing the QoL.

[Primary epiploic appendicitis: CT diagnosis for conservative treatment]. / Les appendicites épiploïques primitives: diagnostic tomodensitométrique pour un traitement conservateur.

OBJECTIVE: Primary epiploic appendicitis is an uncommon, self-limited disease with spontaneous resolution. Diagnosis is usually made at surgery as the disease is generally mistaken for acute appendicitis or sigmoid diverticulitis. CT allows a non-invasive diagnosis, thus avoiding unnecessary surgery. The condition can be managed conservatively with the use of analgesic drugs only, and clinical evolution is uneventful. The aim of this study is to report the CT features of this pathologic process before and after medical treatment by analgesics. PATIENTS AND METHOD: Six patients (4 men and 2 women aged from 23 to 70 year old mean; 29 year old) underwent abdominal CT scan because of acute abdominal pain located in the left lower quadrant (n = 3) and right lower quadrant (n = 3). No patient had fever. Laboratory findings were normal in all cases. Follow-up CT scans were obtained in 4 patients respectively at 2, 4, 8 and 80 weeks. RESULTS: CT scan showed in all cases a fatty mass located to the anterolateral wall of the colon, delineated by an hyper attenuating rim. Infiltration of the pericolic fat was noted in all cases. Follow up CT scans obtained in 4 patients showed that the inflammatory signs had cleared in all cases, the lesion had disappeared (n = 2), decreased in size (n = 1) or a residual paracolic node was observed (n = 1). CONCLUSION: Primary epiploic appendicitis is a rare disease. Knowledge of CT signs allowed the correct diagnosis and a conservative management.