Clinical effects of assessing electronic patient-reported outcomes monitoring symptomatic toxicities during breast cancer therapy: a nationwide and population-based study.

The involvement of cancer patients in symptom reporting talks into our cultural narrative of empowerment and participation in decisions in health of both patients and professionals. Electronic patient-reported outcome (ePRO) is a tool applied for use in such interaction. Based on limited evidence and few empirical studies, health systems are rapidly implementing this instrument in managing patients in active treatment and in follow-up. In a cluster randomized trial of all Danish oncology departments treating breast cancer with adjuvant chemotherapy, we applied ePRO in 347 patients consecutively recruited. Our primary outcome, which was at least one treatment adjustment, was not significantly influenced using ePRO, 34% in the ePRO arm and 41% in the usual care arm received at least one treatment adjustment, p = 0.095. Number of hospitalizations and events of febrile neutropenia were not influenced by the intervention. We believe that one of the main reasons for this finding could be the application of PRO in a well-regulated treatment setting within a public health care system where the most impacting symptomatic toxicities are already taken care off.Trial registration: Clinicaltrials.gov identifier: NCT02996201, registered 19 Dec 2016, retrospectively registered.

Patients' experience of communication and handling of symptomatic adverse events in breast cancer patients receiving adjuvant chemotherapy.

BACKGROUND: The study is based on a national cluster randomized trial investigating the effect of electronic patient-reported outcomes (ePRO) on treatment outcomes in breast cancer patients receiving adjuvant chemotherapy. All 13 oncology departments (11 clusters) treating breast cancer patients in Denmark were randomized to use electronic patient-reported outcomes with real-time clinician feedback (ePRO arm) to track symptoms or usual care for eliciting symptoms using a short paper tracking list (usual care arm). The impact of ePRO on clinical outcomes were examined, which is reported elsewhere. The purpose of the present study was to examine patient-reported experience measure (PREM) regarding communication and handling of side effects/symptoms. METHODS: For this sub-study, patient representatives were involved in the development of a PREM questionnaire. Patients enrolled in the cluster randomized trial completed the PREM questionnaire at their last treatment visit. Semi-structured telephone-interviews were performed with a subgroup of patients. The interviews were based on an interview guide comprised of the questions from the PREM questionnaire and aimed to elaborate on the PREM questionnaire data. RESULTS: A 12 item PREM questionnaire was developed in partnership with patient representatives. In total, 439 out of 682 patients (64.4%) included patients completed the PREM questionnaire. Telephone semi-structured interviews were performed with 22 patients. In total, 52% (ePRO arm) and 65% (usual care arm) reported having talked with the oncologist/nurse about their responses in the tracking systems before each chemotherapy cycle. Fewer patients in the ePRO arm compared to the usual care arm experienced side effects/symptoms not included in the side effect questionnaire. Patients experienced high satisfaction with oncologists' and nurses' handling of side effects/symptoms. CONCLUSIONS: Patients experienced high satisfaction with oncologists' and nurses' handling of chemotherapy adverse events. The study indicates a need for a more comprehensive side effect questionnaire as tracking system covering more symptoms than the one used in usual care today. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02996201. Registered 19 December 2016, retrospectively registered.

Routine surveillance for symptomatic toxicities with real-time clinician reporting in Danish breast cancer patients-Organization and design of the first national, cluster randomized trial using the Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE).

The Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute to capture patient self-reports of symptomatic toxicities during cancer treatment. The aim of this short communication is to describe the design of a national study, which examine the effect of using patients' electronic PRO-CTCAE reporting with real-time feedback to clinicians on treatment events for breast cancer patients receiving adjuvant chemotherapy. The study's end-points are defined as dose reduction, hospitalization, and febrile neutropenia. This is the first report on the impact of PRO-CTCAE in a national breast cancer population during chemotherapy treatment.

The use of PRO in adverse event identification during cancer therapy - choosing the right questions to ask.

Background: Adequate and timely monitoring of adverse events to cancer treatment is from our view dependent on a suitable Patient Reported Outcome (PRO) tool developed for the specific patient population based on cytostatic drugs included in the treatment. Therefore, a systematic method for construction of PRO questionnaires including selection of the appropriate questions is needed. Purpose: The purpose of the present study was to develop and test a method of item selection for a PRO questionnaire to monitor adverse events in oncologic routine treatment of metastatic prostate cancer patients. Patient and methods: Documentation on common symptomatic adverse events for the three drugs was collected from five different sources: 1) FDA product summary information; 2) EMA product summary information; 3) phase 3 Randomized Controlled Trials (RCT) leading to drug approval; 4) audit of the electronic patient files focusing on the oncologist's documentation of adverse events and 5) individual patient interview (n = 16) focusing on adverse events. The Patient Reported Outcome of Common Terminology Criteria for Adverse Events (PRO-CTCAE) was used as PRO item library. Selected symptoms were transformed into corresponding PRO-CTCAE questions. The questionnaire was tested by patients in a pilot test (n = 12). Patients for interviews and pilot testing were included by purposive sampling. Results: A method for constructing a PRO questionnaire was developed, and a questionnaire of 25 PRO-CTCAE symptoms with 46 questions including an open write-in space for additional adverse events was constructed and tested. Conclusion: This study demonstrates a systematic method to select questions on adverse events for a PRO questionnaire in a specific cancer population receiving oncologic treatment. The present study reveals that audit of patient files and patient interviews in our setting only add little to the information on adverse events obtained from FDA, EMA and RCT. The obtained questionnaire was found useful and acceptable by patients.

Danish translation and pilot testing of the European Organization for Research and Treatment of Cancer QLQ-TC 26 (EORTC QLQ-TC26) questionnaire to assess health-related quality of life in patients with testicular cancer.

BACKGROUND: The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 is a core questionnaire designed to evaluate health-related quality of life (HRQoL) of cancer patients participating in international clinical trials. It is available in several languages including Danish. The EORTC QLQ-TC26 is a supplemental module developed for patients with testicular cancer, which can be useful in clinical trials. Despite Denmark holding a high prevalence and incidence of testicular cancer, no Danish translation was previously available. This paper describes the translation process and pilot testing of the Danish translation of QLQ-TC26. METHODS: The English language EORTC QLQ-TC26 was translated into Danish using forward and backward procedures with reconciliation. The translated instrument was assessed in semi structured cognitive interviews in a sample of 10 patients ages 20-56 receiving treatment for testicular cancer. RESULTS: In one round of pilot testing, no changes were required for the Danish translation based upon patient comments. The Danish translation was agreed by participants to be both culturally acceptable and semantically comprehensible. CONCLUSIONS: The pilot testing of the Danish translation of the EORTC QLQ-TC26 was performed in one round of patient interviews; these results support the Danish translation as a comparable instrument to the English language version. However, further validation is required to ensure complete equivalency. These results support the use of the EORTC QLQ-TC26 in future clinical trials conducted with Danish-speaking patients.

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.

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.

Quality deviations in cancer diagnosis: prevalence and time to diagnosis in general practice.

BACKGROUND: High quality in every phase of cancer diagnosis is important to optimise the prognosis for the patient. General practice plays an important role in this phase. AIM: The aim was to describe the prevalence and the types of quality deviations (QDs) that arise during the diagnostic pathway in general practice as assessed by GPs and to analyse the association between these QDs, the cancer type, and the GP's interpretation of presenting symptoms as well as the influence on the diagnostic interval. DESIGN AND SETTING: A Danish retrospective cohort study based on questionnaire data from 1466 GPs on 5711 incident patients with cancer identified in the Danish National Patient Registry (response rate = 71.4%). The GP was involved in diagnosing in 4036 cases. METHOD: Predefined QDs were prompted with the possibility for free text. QD prevalence was estimated as was the association between QDs and diagnosis, the GP's symptom interpretation, and time to diagnosis. RESULTS: QDs were present for 30.4% (95% confidence interval [CI] = 29.0 to 31.9) of cancer patients. The most prevalent QD was 'retrospectively, one or more of my clinical decisions were less optimal'. QDs were most prevalent among patients with vague symptoms (24.1% for alarm symptoms versus 39.5% for vague symptoms [P<0.001]). QD presence implied a 41-day (95% CI = 38.4 to 43.6) longer median diagnostic interval. CONCLUSION: GPs noted at least one QD, which often involved clinical decisions, for one-third of all cancer patients. QDs were more likely among patients with vague symptoms and increased the diagnostic interval considerably.

Safety hazards in cancer care: findings using three different methods.

BACKGROUND: Patients with cancer are at risk of injury during treatment. Some injuries are preventable, but prevention requires knowledge about the hazards. Aims To identify hazards and injuries relating to Danish patients with cancer (types and severity) and to test three different methods of identifying cancer-specific hazards. METHODS: Adverse events in cancer care were identified through reports from healthcare staff to the Danish Patient Safety Database, a retrospective chart review using the Global Trigger Tool, and reports to the Danish Cancer Society from patients with cancer and their relatives. Events were typed using the draft International Classification for Patient Safety. Severity was assessed by Safety Assessment Coding, the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) and qualitative assessment. RESULTS: 2429 cancer-related adverse event reports were found on the Danish Patient Safety Database, 260 adverse events were identified using the Global Trigger Tool, and 151 safety events were reported by patients and their relatives. Cancer-specific adverse events and general safety problems were identified. In most cases injury to patients was temporary but severe and permanent injury occurred with a relatively high frequency. CONCLUSION: Patients with cancer are at risk of injury from cancer treatment procedures and as a consequence of problems related to administrative processes and communication. Types of identified events varied according to the methods used, and each method added new information. Further research on patient safety in cancer care and safety-enhancing activities is needed.

Comprehensive discharge follow-up in patients' homes by GPs and district nurses of elderly patients. A randomized controlled trial.

OBJECTIVES: Many hospital admissions are due to inappropriate medical treatment, and discharge of fragile elderly patients involves a high risk of readmission. The present study aimed to assess whether a follow-up programme undertaken by GPs and district nurses could improve the quality of the medical treatment and reduce the risk of readmission of elderly newly discharged patients. DESIGN AND SETTING: The patients were randomized to either an intervention group receiving a structured home visit by the GP and the district nurse one week after discharge followed by two contacts after three and eight weeks, or to a control group receiving the usual care. PATIENTS: A total of 331 patients aged 78+ years discharged from Glostrup Hospital, Denmark, were included. MAIN OUTCOME MEASURES: Readmission rate within 26 weeks after discharge among all randomized patients. Control of medication, evaluated 12 weeks after discharge on 293 (89%) of the patients by an interview at home and by a questionnaire to the GP. RESULTS: Control-group patients were more likely to be readmitted than intervention-group patients (52% v 40%; p = 0.03). In the intervention group, the proportions of patients who used prescribed medication of which the GP was unaware (48% vs. 34%; p = 0.02) and who did not take the medication prescribed by the GP (39% vs. 28%; p = 0.05) were smaller than in the control group. CONCLUSION: The intervention shows a possible framework securing the follow-up on elderly patients after discharge by reducing the readmission risk and improving medication control.

Utilisation of antibiotics in young children: opposite relationships to adult educational levels in Danish and Swedish counties.

BACKGROUND: Antibiotic utilisation varies profoundly among and within countries, and the extent of antibiotic utilisation correlates with the frequency of bacterial resistance, particularly among children. Hence, it is important to assess which factors may influence prescribing. In addition to variations in morbidity, health-care organisation, drug regulatory and supply systems, prescriber's attitudes, parents' behaviour, attitudes and socio-economic positions seem important. We compared socio-economic position (educational level of adults) and antibiotic utilisation in children in the municipalities within a Danish and a Swedish county which are geographically close, have similar social and economic development, and similar drug regulatory and supply systems. METHODS: Data on antibiotic utilisation (1998), expressed in defined daily doses per 1000 inhabitants per day (DDD/TID), were obtained from the Copenhagen County Health Insurance register and from the National Corporation of Swedish Pharmacies. Data on municipal educational levels were obtained from Statistics Denmark and Statistics Sweden. RESULTS: The utilisation of antibiotics in 0- to 6-year-old children was higher in the Swedish than in the Danish county but varied between the municipalities within both the Swedish (9.6-17.7 DDD/TID) and the Danish (8.0-12.9 DDD/TID) counties. Most notably, utilisation rates correlated negatively with the education levels in the Danish (r=-0.539, P=0.021) but positively in the Swedish (r=+0.390, P=0.025) municipalities. CONCLUSION: The observed variations in antibiotic prescribing may reflect different parental and/or prescriber attitudes towards use of antibiotics and they emphasise that antibiotic prescribing is influenced by factors other than the prevalence of bacterial infections. Relationships between socio-economic position (educational level) and drug utilisation should not be generalised from one area to another.