The development and initial validation of the Breast Cancer Recurrence instrument (BreastCaRe)—a patient-reported outcome measure for detecting symptoms of recurrence after breast cancer

Purpose: Patient-reported outomes (PRO) may facilitate prompt treatment. We describe the development and psychometric properties of the first instrument to monitor for symptoms of breast cancer (BC) recurrence. Methods: This study is nested in the MyHealth randomized trial of nurse-led follow-up based on electronically-collected PROs. We constructed items assessing symptoms of potential recurrence through expert interviews with six BC specialists in Denmark. Semi-structured cognitive interviews were carried out with a patient panel to assess acceptability and comprehensibility. Items were subsequently tested in a population of 1170 women 1–10 years after completing BC treatment. We carried out multiple-groups confirmatory factor analysis (CFA) and Rasch analysis to test dimensionality, local dependence (LD) and differential item functioning (DIF) according to sociodemographic and treatment-related factors. Clinical data was obtained from the Danish Breast Cancer Group registry. Results: Twenty-two items were generated for the Breast Cancer Recurrence instrument (BreastCaRe). Cognitive testing resulted in clearer items. Seven subscales based on general, bone, liver, lung, brain, locoregional and contralateral recurrence symptoms were proposed. Both CFA and Rasch models confirmed the factor structure. No DIF was identified. Five item pairs showed LD but all items were retained to avoid loss of clinical information. Rasch models taking LD into account were used to generate a standardized scoring table for each subscale. Conclusions: The BreastCaRe has good content and structural validity, patient acceptability and measurement invariance. We are preparing to examine the predictive validity of this new instrument

Danish Translation and Linguistic Validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Context The Common Terminology Criteria for Adverse Events (CTCAE) is the basis for standardized clinician-based grading and reporting of adverse events in cancer clinical trials. The U.S. National Cancer Institute has developed the Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE) to incorporate patient self-reporting of symptomatic adverse events. Objectives The aim of the study was to translate and linguistically validate a Danish language version of PRO-CTCAE. Methods The U.S. English language PRO-CTCAE was translated into Danish using forward and backward procedures with reconciliation. The linguistic validity of the PRO-CTCAE Danish was examined in two successive rounds of semistructured cognitive interviews in a sample of 56 patients equally distributed by gender and cancer type (prostate, head and neck, lung, breast, gynecological, gastrointestinal, and hematological cancer), and who were currently undergoing cancer treatment. Results In the first round of linguistic validation (n = 42), the phrasing of five symptomatic toxicities was adjusted, and the refined phrasing was retested in a second round of interviews (n = 14). Agreement about phrasing that was both culturally acceptable and semantically comprehensible was achieved in the second round. Statements from participants describing the meaning of the PRO-CTCAE symptomatic toxicities support conceptual equivalence to the U.S. English language version. Conclusion Availability of the NCI PRO-CTCAE in languages beyond English will support international congruence in self-reporting of side effects of cancer treatment. A rigorous methodology was used to develop the Danish language version of PRO-CTCAE. Results provide preliminary support for the use of PRO-CTCAE in cancer clinical trials that include Danish speakers

Feasibility and acceptability of electronic symptom surveillance with clinician feedback using the patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) in Danish prostate cancer patients

Background: The aim was to examine the feasibility, acceptability and clinical utility of electronic symptom surveillance with clinician feedback using a subset of items drawn from the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) in a cancer treatment setting. Methods: Danish-speaking men with castration-resistant metastatic prostate cancer receiving treatment at the Department of Oncology, Rigshospitalet, Copenhagen between March 9, 2015 and June 8, 2015 were invited to participate (n = 63 eligible). Participants completed the PRO-CTCAE questionnaire on tablet computers using AmbuFlex software at each treatment visit in the outpatient clinic. In total, 22 symptomatic toxicities (41 PRO-CTCAE items), corresponding to the symptomatic adverse-events profile associated with the regimens commonly used for prostate cancer treatment (Docetaxel, Cabazitaxel, Abiraterone, Alpharadin), were selected. Participants’ PRO-CTCAE responses were presented graphically to their treating oncologists via an AmbuFlex dashboard, for real-time use to enhance the patient-clinician dialogue that occurs during the consultation prior to each treatment cycle. Technical and clinical barriers and acceptability were evaluated through semi-structured interviews with both patients and oncologists. Patients receiving active treatment at the end of the study period completed an evaluation questionnaire. Results: Fifty-four out of sixty-three (86%) eligible patients were enrolled. The PRO-CTCAE questionnaire was completed a total of 168 times by 54 participants (median number per patient was 3, range 1–5). Eight surveys were missed, resulting in a compliance rate of 97%. At the end of the study period, 35 patients (65%) were still receiving active treatment and completed the evaluation questionnaire. Patients reported that their PRO-CTCAE responses served as a communication tool. Oncologists stated that the availability of the PRO-CTCAE self-reports during the consultation improved patient-clinician communication about side effects. Conclusion: Electronic capture of symptomatic toxicities using PRO-CTCAE and the submission of self-reports to clinicians prior to consultation were feasible among metastatic prostate cancer patients receiving chemotherapy in an outpatient setting, and this procedure was acceptable to both patients and clinicians. Continued research, including a cluster-randomized trial, will evaluate the effects of submitting patients’ PRO-CTCAE results to clinicians prior to consultation on the quality of side-effects management and resultant clinical outcomes

Suitability of Who Criteria for Quality Assessment in Teenage Boys Undergoing Sperm Banking for Fertility Preservation Prior to Potentially Gonadotoxic Treatment

Background/Objectives: Children who are treated for childhood cancer are exposed to hospitalization, interaction with unfamiliar people in strange environments, and unpleasant, and sometimes, procedures. Having to wait for procedures is one of the worst situations, experienced by child patients. It is therefore important that hospitals provide environments that are non-stressful and safe for children in conjunction with procedures. Especially important, is the possibility for children who are hospitalized to sustain everyday activities, such as play, irrespective of their age and severity of illness. Objective: To assess differences in expenditure of time and dose of anesthetic drugs during sedation for intrathecal chemotherapy in two different environments- the children's ward, where the child was hospitalized, and the operation theatre. Design/Methods: The study is based on retrospective data from repeated treatment sessions recorded in operation planning programs and journals during 2011-2018 (n=164). Children of the ages 1-12 years (n=22) with varying number of treatments were included in the study. Data was analyzed with the Kruskal-Wallis test and post-hoc analyses included the Mann-Whitney Test with Bonferroni correction. Results: The time from the start of the procedure until the start of sedation was significantly lower at the children's ward, which was also the case if including the waiting time before the start of the procedure. No significant differences could be found regarding the dose of anesthetic drugs used. Conclusions: Sedation for intrathecal chemotherapy at the children's ward provides care to a higher extent in accordance with the needs of the child, by reducing the time for the procedure and thus the interference with the child’s everyday life at the hospital. © 2019 Wiley Periodicals, Inc

Tuberculous meningitis in Denmark: a review of 50 cases

<p>Abstract</p> <p>Background</p> <p>Tuberculous meningitis is the most severe manifestation of extrapulmonary tuberculosis with a high mortality rate and a high rate of sequelae among survivors. The aim of this study is to assess the current epidemiology, clinical features, diagnostic procedures, treatment and outcome in patients with tuberculous meningitis in Denmark, a country with a low tuberculosis incidence.</p> <p>Methods</p> <p>A nationwide retrospective study was conducted, comprising all patients notified with tuberculous meningitis (TBM) in Denmark from 2000-2008. Medical records were reviewed using a standardised protocol.</p> <p>Results</p> <p>Fifty patients, including 12 paediatric patients, were identified. 78% of the patients were immigrants from countries of high tuberculosis endemicity. 64% of all patients had a pre-existing immunosuppressive condition; 10% were HIV positive, 48% were HIV seronegative and 42% had an unknown HIV status. Median symptom duration before admission was 14 days in the Danish patient population and 20 days in the immigrant group. Biochemical analysis of cerebrospinal fluid (CSF) samples revealed pleocytosis in 90% with lymphocyte predominance in 66%. Protein levels were elevated in 86%. The most common findings on neuro-radiological imaging were basal meningeal enhancement, tuberculomas and hydrocephalus. Lumbar puncture was performed on 42 patients; 31 of these specimens (74%) had a positive CSF culture for mycobacteria and 9.5% were smear positive for acid-fast bacilli. The overall mortality rate was 19% and 48% of the remaining patients had neurological sequelae of varying degree.</p> <p>Conclusion</p> <p>TBM is a rare but severe manifestation of extrapulmonary TB in Denmark. The clinician must be prepared to treat empirically if the suspicion of TBM has arisen to improve treatment outcome.</p

Smoking onset and the time-varying effects of self-efficacy, environmental smoking, and smoking-specific parenting by using discrete-time survival analysis

This study examined the timing of smoking onset during mid- or late adolescence and the time-varying effects of refusal self-efficacy, parental and sibling smoking behavior, smoking behavior of friends and best friend, and parental smoking-specific communication. We used data from five annual waves of the ‘Family and Health’ project. In total, 428 adolescents and their parents participated at baseline. Only never smokers were included at baseline (n = 272). A life table and Kaplan–Meier survival curve showed that 51% of all adolescents who did not smoke at baseline did not start smoking within 4 years. The risk for smoking onset during mid- or late adolescence is rather stable (hazard ratio between 16 and 19). Discrete-time survival analyses revealed that low refusal self-efficacy, high frequency of communication, and sibling smoking were associated with smoking onset one year later. No interaction effects were found. Conclusively, the findings revealed that refusal self-efficacy is an important predictor of smoking onset during mid- or late adolescence and is independent of smoking-specific communication and smoking behavior of parents, siblings, and (best) friend(s). Findings emphasize the importance of family prevention programs focusing on self-efficacy skills