Symptoms in the general Norwegian adult population - prevalence and associated factors.

BACKGROUND: Patients´ own perceptions and evaluations of symptoms, functioning and other health-related factors, i.e. Patient Reported Outcomes (PROs), are important elements for providing good patient care. Symptoms are subjective and best elicited by the patient orally or by using PRO measures (PROMs), be it on paper, or as electronic assessment tools. Reference values on frequently used PROMs facilitate the interpretation of scores for use in clinics and research settings, by comparing patient data with relevant samples from the general population. Study objectives were to (1) present reference values for the M.D. Anderson Symptom Inventory (MDASI) (2) examine the occurrence and intensity of symptoms assessed by the MDASI in a general Norwegian adult population sample, and (3) examine factors associated with higher symptom burden defined as the sum score of all symptoms, and factors associated with symptoms` interference on functions. METHODS: In 2015, MDASI was sent by mail as part of a larger survey, to a representative sample of the general Norwegian adult population (N = 6165). Medical comorbidities were assessed by the Self-Administered Comorbidity Questionnaire. Depression was self-reported on the Patient Health Questionnaire 9 (PHQ-9). Linear multivariable regression analysis was used to examine for factors associated with MDASI sum score and factors associated with symptoms' interference on functions. RESULTS: The response rate was 36%. More women (54%) than men (46%) responded. Mean age was 55 years (SD 14). The most frequent symptoms were fatigue (59.7%), drowsiness (56.2%) and pain (56.1%). Fatigue, pain and disturbed sleep had the highest mean scores. The presence of one or more comorbidities, increasing PHQ-9 score and lower level of education were associated with higher MDASI sum score (p < 0.001). The MDASI sum score and the PHQ-9 score were positively associated with all interference items (p < 0.001) except for walking (p = 0.22). CONCLUSION: This study provides the first Norwegian reference values for MDASI. The presence of one or more comorbidities, higher level of depressive symptoms and lower level of education were significantly associated with higher MDASI sum score. These covariates must be controlled for when using the reference values.

PALLiON - PALLiative care Integrated in ONcology: study protocol for a Norwegian national cluster-randomized control trial with a complex intervention of early integration of palliative care.

BACKGROUND: Several publications have addressed the need for a systematic integration of oncological care focused on the tumor and palliative care (PC) focused on the patient with cancer. The exponential increase in anticancer treatments and the high number of patients living longer with advanced disease have accentuated this. Internationally, there is now a persuasive argument that introducing PC early during anticancer treatment in patients with advanced disease has beneficial effects on symptoms, psychological distress, and survival. METHODS: This is a national cluster-randomized trial (C-RCT) in 12 Norwegian hospitals. The trial investigates effects of early, systematic integration of oncology and specialized PC in patients with advanced cancer in six intervention hospitals compared with conventional care in six. Hospitals are stratified on the size of local catchment areas before randomization. In the intervention hospitals, a three-part complex intervention will be implemented. The backbone of the intervention is the development and implementation of patient-centered care pathways that contain early, compulsory referral to PC and regular and systematic registrations of symptoms. An educational program must be completed before patient inclusion. A total of 680 patients with advanced cancer and one caregiver per patient are included when patients come for start of last line of chemotherapy, defined according to national treatment guidelines. Data registration, clinical variables, and patient- and caregiver-reported outcomes take place every 2 months for 1 year or until death. The primary outcome is use of chemotherapy in the last 3 months of life by comparing the proportion of patients who receive this in the intervention and control groups. Primary outcome is use of chemotherapy in the last 3 months before death, i.e. number of patients. Secondary outcomes are initiation, discontinuation and number of cycles, last 3 months of life, administration of other medical interventions in the last month of life, symptom burden, quality of life (QoL), satisfaction with information and follow-up, and caregiver health, QoL, and satisfaction with care. DISCUSSION: Results from this C-RCT will be used to raise the awareness about the positive outcomes of early provision of specialized palliative care using pathways for patients with advanced cancer receiving medical anticancer treatment. The long-term clinical objective is to integrate these patient-centered pathways in Norwegian cancer care. The specific focus on the patient and family and the organization of a predictable care trajectory is consistent with current Norwegian strategies for cancer care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03088202. Registered on 23 March 2017.

Usability testing of EirV3-a computer-based tool for patient-reported outcome measures in cancer.

PURPOSE: Eir version 3 (V3) is an electronic tool for administration of patient-reported outcome measures (Eir-Patient) that immediately presents patient scores on the physician's computer (Eir-Doctor). Perceived usability is an important determinant for successful implementation. The aim of this study was to answer the following research question evaluated at the cancer outpatient clinics, in the patients' home, and at general practitioners' (GPs) offices: What are the number, type, and severity of usability issues evaluated by the patient (Eir-Patient module) and by the physician (Eir-Doctor module)? METHODS: A usability evaluation using observations, think-aloud sessions, individual interviews and focus group interviews in cancer patients and their physicians was conducted. Identified usability issues were graded on a severity scale from 1 (irritant) to 4 (unusable). RESULTS: Overall, 73 Eir registrations were performed by 37 patients, and used by 17 physicians in clinical consultations. All patients were able to complete the Eir-Patient symptom registration. Seventy-two usability issues were identified. None of them were graded as unusable. For the Eir-Patient module, 62% of the identified usability issues was graded as irritant (grade 1), 18% as moderate (grade 2), and 20% as severe (grade 3). For the Eir-Doctor module, 46% of the identified usability issues were graded as irritant, 36% as moderate and 18% as severe. CONCLUSIONS: In the updated Eir version, issues in the severe and moderate categories have been changed, to optimize the usability of using real-time PROMs in clinical practice.

Development of EirV3: A Computer-Based Tool for Patient-Reported Outcome Measures in Cancer.

PURPOSE: Immediate transfer of patient-reported outcome measures (PROMs) for use in medical consultations is facilitated by electronic assessments. We aimed to describe the rationale and development of Eir version 3 (EirV3), a computer-based symptom assessment tool for cancer, with emphasis on content and user-friendliness. METHODS: EirV3's specifications and content were developed through multiprofessional, stepwise, and iterative processes (from 2013 to 2016), with literature reviews on traditional and electronic assessment and classification methods, formative iterative usability tests with end-users, and assessment of patient preferences for paper versus electronic assessments. RESULTS: EirV3 has the following two modules: Eir-Patient for PROMs registration on tablets and Eir-Doctor for presentation of PROMs in a user-friendly interface on computers. Eir-Patient starts with 19 common cancer symptoms followed by specific, in-depth questions for endorsed symptoms. The pain section includes a body map for pain location and intensity, whereas physical functioning, nutritional intake, and well-being are standard questions for all. Data are wirelessly transferred to Eir-Doctor. Symptoms with intensity scores ≥ 3 (on a 0 to 10 scale) are marked in red, with brighter colors corresponding to higher intensity, and supplemented with graphs displaying symptom development over time. Usability results showed that patients and health care providers found EirV3 to be intuitive, easy to use, and relevant. When comparing PROM assessments on paper versus tablets (n = 114), 19% of patients preferred paper, 41% preferred tablets, and 40% had no preference. Median intraclass correlation coefficient between paper and tablets (0.815) was excellent. CONCLUSION: Iterative test rounds followed by continuous improvements led to a user-friendly, applicable symptom assessment tool, EirV3, developed for and by end-users. EirV3 is undergoing international testing of clinical and cross-cultural adaptability.