Using a modified Delphi procedure to select a PRO-CTCAE-based subset for patient-reported symptomatic toxicity monitoring in rectal cancer patients.

PURPOSE: Standardized patient-reported outcomes (PRO) monitoring during and after rectal cancer treatment provides insight into treatment-related toxicities patients experience and improves health-related quality-of-life as well as overall survival. We aimed to select a subset of the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for standardized monitoring of treatment-related symptomatic toxicities in rectal cancer. METHODS: We used a mixed methods approach including a literature review, and semi-structured interviews with health care providers (HCPs) involved in rectal cancer care and rectal cancer patients. Results from literature and interviews were summarized and used in a modified Delphi procedure to select a PRO-CTCAE subset specific for rectal cancer. RESULTS: Twenty-six PRO-CTCAE symptomatic toxicities were identified from literature. Fifteen HCPs from multiple disciplines (medical, radiation and surgical oncology), and a heterogeneous group of fifteen rectal cancer patients treated with chemotherapy and/or radiotherapy and/or surgery, participated in semi-structured interviews. Ten HCPs (67%) and nine patients (90%) participated in the first Delphi round. The final selected PRO-CTCAE core-subset contained 16 symptomatic toxicities: 'diarrhea', 'fecal incontinence', 'constipation','bloating of the abdomen', 'pain in the abdomen', 'vomiting', 'decreased libido', 'pain during vaginal sex', 'ability to achieve and maintain erection', 'fatigue', 'anxiety', 'feeling that nothing could cheer you up', 'urinary incontinence', 'painful urination', 'general pain', and 'hand-foot syndrome'. CONCLUSION: Based on a comprehensive mixed methods study, a PRO-CTCAE subset for standardized treatment-related symptomatic toxicity monitoring in rectal cancer was identified. Assessment of the effectiveness and compliance of symptomatic toxicity monitoring using this subset is recommended.

Mandibular changes secondary to serial extractions compared with late premolar extractions and controls.

INTRODUCTION: Variations in treatment times for serial extraction and late premolar extraction patients may be due to differences in the time needed to flatten the occlusal curves. In this study, we compared tooth tipping and occlusal curves in patients treated by serial extractions or late premolar extractions with untreated controls. METHODS: Mandibular dental casts and cephalometric radiographs were collected from 90 subjects (30 Class I control subjects, 30 patients with serial extractions, and 30 with late premolar extractions) at 3 time points: T0, baseline for the controls and serial extraction patients; T1, after natural drift and preorthodontics for the controls and the serial extraction patients, and pretreatment for the late premolar extraction patients; and T2, after comprehensive orthodontic treatment for the serial extraction and the late premolar extraction groups. The long axes of the central incisor, canine, and first molar to the palatal plane were measured on digitized headfilms to determine the direction and the amount of tipping between the time points. Three occlusal curves were measured by sphere fitting cusp-tip landmarks on digitized mandibular casts. RESULTS: From T0 to T1, incisors and canines in the patients with serial extractions tipped distally. Molars at T1 in the patients with serial extractions were tipped forward more than in the late premolar extraction patients and the controls. From T1 to T2, canines and molars in the patients with serial extractions were uprighted. CONCLUSIONS: Serial extractions produce steeper occlusal curves and distal tipping of the incisors and canines after drift (T1). Posttreatment (T2) occlusal curves in the patients with serial extractions are steeper than in the late premolar extraction patients and controls (except for the curve of Spee). After the serial extractions, orthodontic treatment included incisor and canine proclination, with molar uprighting and occlusal curve flattening.

SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial.

INTRODUCTION: Lung cancer and its treatment cause a wide range of symptoms impacting the patients' health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands.The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness. METHODS AND ANALYSIS: The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I-IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy.Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding. ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences. TRIAL REGISTRATION NUMBER: Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897.

Research with spanish-speaking populations in the United States: lost in the translation. A commentary and a plea.

Verbal material used to assess the cognitive abilities of Spanish-speakers in the the United States is frequently of linguistically unacceptable quality. The use of these materials in research settings is thought to pose a serious threat to test validity and hence to the validity of claimed results or conclusions. The authors explain how and why incorrect language finds its way into cognitive tests used in research and other settings and suggest solutions to this serious problem.