Niels Henrik Hjollund

PURPOSE: Remote symptom monitoring of patients with cancer has previously shown potential for improving clinical outcomes. This study aimed to evaluate the effects of remote symptom monitoring in patients with lung cancer after palliative induction treatment. METHODS: In a Danish multicenter randomized controlled trial, patients were randomly assigned 1:1 to remote symptom monitoring (intervention arm) added to standard of care versus standard of care (control arm). Key eligibility criteria were stage III-IV lung cancer (small cell lung cancer and non–small cell lung cancer), Eastern Cooperative Oncology Group performance status ≤2, and no sign of disease progression after initial induction treatment. Patients in the intervention arm completed a weekly electronic questionnaire, assessing 14 common symptoms related to lung cancer. When a patient reported a severity exceeding a predefined threshold, the patient was subsequently contacted by phone to address potential clinical needs. Symptom monitoring was discontinued after progression. The primary outcome was overall survival (OS). Secondary measures included assessment of health-related quality of life (HRQoL). RESULTS: Of 494 randomly assigned patients, 240 were assigned to the intervention arm and 254 were assigned to the control arm. At a median follow-up of 3.5 years, symptom monitoring did not significantly improve OS compared with standard care (hazard ratio [HR], 0.93 [95% CI, 0.75 to 1.16]; P = .53). Exploratory subgroup analyses indicated improved survival for patients treated with carboplatin/vinorelbine (HR, 0.67 [95% CI, 0.45 to 0.98]; P = .04) and in departments with previous implementation of patient-reported outcomes (HR, 0.66 [95% CI, 0.44 to 0.98]; P = .04). HRQoL analyses did not reveal clinically meaningful effects. CONCLUSION: In the Danish health care system, remote symptom monitoring did not improve OS but led to modest improvements in HRQoL for patients with advanced lung cancer.

Background: In Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse of remote patient-reported outcomes (PROs) is a well-known challenge, and it can be difficult to explain which mechanisms of interventions influence the outcome. Process evaluation may, therefore, be used to answer important questions on how and why interventions work, aiming to enhance the implications for clinical practice. Objective: This study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician use patterns, (3) patient adherence to the intervention, and (4) clinical engagement. Methods: A process evaluation determining the reach, dose, fidelity, and clinical engagement was carried out, alongside a multicenter randomized controlled trial (RCT). We developed and implemented an intervention using PRO measures to monitor outpatients remotely. Data were collected for the PRO intervention arms in the RCT from 4 sources: (1) PRO data from the participants to determine personal factors, (2) the web-based PRO system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semistructured interviews conducted with involved physicians. Results: Of the 320 patients invited, 152 (47.5%) accepted to participate. The study population reflected the target population. The mean adherence rate to the PRO intervention arms was 82% (95% CI 76-87). The questionnaire response rate was 539/544 (99.1%). A minority of 13 (12.9%) of 101 patients needed assistance to complete study procedures. Physicians assessed 477/539 (88.5%) of the questionnaires. Contact was established in 417/539 (77.4%) of the cases, and 122/539 (22.6%) of the patients did not have contact. Physicians initiated 288/417 (69.1%) and patients requested 129/417 (30.9%) of all the contacts. The primary causes of contact were clinical data (242/417, 58%), PRO data (92/417, 22.1%), and medication concerns and precautionary reasons (83/417, 19.9%). Physicians found the use of PRO measures in remote follow-up beneficial for assessing the patient’s health. The inclusion of self-reported clinical data in the questionnaire motivated physicians to assess patient responses. However, some barriers were emphasized, such as loss of a personal relationship with the patient and the risk of missing important symptoms in the absence of a face-to-face assessment. Conclusions: This study demonstrates the importance and practical use of remote monitoring among patients with CKD. Overall, the intervention was implemented as intended. We observed high patient adherence rates, and the physicians managed most questionnaires. Some physicians worried that distance from the patients made it unfeasible to use their “clinical glance,” posing a potential risk of overlooking crucial patients‘ symptoms. These findings underscore key considerations for the implementation of remote follow-up. Introducing a hybrid approach combining remote and face-to-face consultations may address these concerns. Trial Registration: ClinicalTrials.gov NCT03847766; https://clinicaltrials.gov/study/NCT03847766

BACKGROUND In Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse of remote patient-reported outcomes (PROs) is a well-known challenge, and it can be difficult to explain which mechanisms of interventions influence the outcome. Process evaluation may, therefore, be used to answer important questions on how and why interventions work, aiming to enhance the implications for clinical practice. OBJECTIVE This study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician use patterns, (3) patient adherence to the intervention, and (4) clinical engagement. METHODS A process evaluation determining the reach, dose, fidelity, and clinical engagement was carried out, alongside a multicenter randomized controlled trial (RCT). We developed and implemented an intervention using PRO measures to monitor outpatients remotely. Data were collected for the PRO intervention arms in the RCT from 4 sources: (1) PRO data from the participants to determine personal factors, (2) the web-based PRO system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semistructured interviews conducted with involved physicians. RESULTS Of the 320 patients invited, 152 (47.5%) accepted to participate. The study population reflected the target population. The mean adherence rate to the PRO intervention arms was 82% (95% CI 76-87). The questionnaire response rate was 539/544 (99.1%). A minority of 13 (12.9%) of 101 patients needed assistance to complete study procedures. Physicians assessed 477/539 (88.5%) of the questionnaires. Contact was established in 417/539 (77.4%) of the cases, and 122/539 (22.6%) of the patients did not have contact. Physicians initiated 288/417 (69.1%) and patients requested 129/417 (30.9%) of all the contacts. The primary causes of contact were clinical data (242/417, 58%), PRO data (92/417, 22.1%), and medication concerns and precautionary reasons (83/417, 19.9%). Physicians found the use of PRO measures in remote follow-up beneficial for assessing the patient’s health. The inclusion of self-reported clinical data in the questionnaire motivated physicians to assess patient responses. However, some barriers were emphasized, such as loss of a personal relationship with the patient and the risk of missing important symptoms in the absence of a face-to-face assessment. CONCLUSIONS This study demonstrates the importance and practical use of remote monitoring among patients with CKD. Overall, the intervention was implemented as intended. We observed high patient adherence rates, and the physicians managed most questionnaires. Some physicians worried that distance from the patients made it unfeasible to use their “clinical glance,” posing a potential risk of overlooking crucial patients‘ symptoms. These findings underscore key considerations for the implementation of remote follow-up. Introducing a hybrid approach combining remote and face-to-face consultations may address these concerns. CLINICALTRIAL ClinicalTrials.gov NCT03847766; https://clinicaltrials.gov/study/NCT03847766

Background: Patient-reported Outcome (PRO) measures may be used as the basis for out-patient follow-up instead of fixed appointments. The patients attend follow-up from home by filling in questionnaires developed for that specific aim and patient group (telePRO). The questionnaires are handled in real time by a specific algorithm, which assigns an outcome color reflecting clinical need. The specific questionnaires and algorithms (named solutions) are constructed in a consensus process with clinicians. We aimed to describe AmbuFlex’ telePRO solutions and the algorithm outcomes and variation between patient groups, and to discuss possible applications and challenges. Methods: TelePRO solutions with more than 100 processed questionnaires were included in the analysis. Data were retrieved together with data from national registers. Characteristics of patients, questionnaires and outcomes were tabulated for each solution. Graphs were constructed depicting the overall and within-patient distribution of algorithm outcomes for each solution. Results: From 2011 to 2021, 29 specific telePRO solutions were implemented within 24 different ICD-10 groups. A total of 42,015 patients were referred and answered 171,268 questionnaires. An existing applicable instrument with cut-off values was available for four solutions, whereas items were selected or developed ad hoc for the other solutions. Mean age ranged from 10.7 (Pain in children) to 73.3 years (chronic kidney disease). Mortality among referred patients varied between 0 (obesity, asthma, endometriosis and pain in children) and 528 per 1000 patient years (Lung cancer). There was substantial variation in algorithm outcome across patient groups while different solutions within the same patient group varied little. Discussion: TelePRO can be applied in diseases where PRO can reflect clinical status and needs. Questionnaires and algorithms should be adapted for the specific patient groups and clinical aims. When PRO is used as replacement for clinical contact, special carefulness should be observed with respect to patient safety.

Background: Patient-reported outcome (PRO) measures may be used in telehealth for the clinical assessment of mental health and diabetes distress, which are important aspects in diabetes care, but valid and reliable instruments on these topics are necessary. We aimed to evaluate the test–retest reliability and measurement error of the Danish versions of the WHO-Five Well-being Index (WHO-5) and Problem Areas in Diabetes (PAID) questionnaires used in a PRO-based telehealth intervention among patients with type 1 diabetes. A further aim was to evaluate the test–retest reliability of single items concerning patients’ symptom burden and general health status. Methods: Outpatients with type 1 diabetes from the Steno Diabetes Center Aarhus, Aarhus University Hospital, Denmark, were enrolled from April 2019 to June 2020. Patients aged ≥ 18 who had type 1 diabetes for > 1 year, internet access, and the ability to understand, read, and write Danish were included. Intraclass correlation coefficients (ICC) and weighted Kappa values were used to assess test–retest reliability, and measurement error was assessed by estimating the minimal detectable change (MDC). Results: A total of 146/255 (57%) patients completed the web questionnaire twice. The median response time between the two-time points was five days. The ICC of the WHO-5 scale was 0.87 (95% CI 0.82–0.90), and MDC was 18.56 points (95% CI 16.65–20.99). The ICC of the PAID scale was 0.89 (95% CI 0.84–0.92), and MDC was 11.86 points (95% CI 10.46–13.70). Overall, test–retest reliability of single symptoms and general health status items was substantial. Conclusions: The WHO-5 and PAID questionnaires, and single symptoms and general health status items showed substantial test–retest reliability among patients with type 1 diabetes. Measurement error of the PAID questionnaire was considered acceptable; however, a larger measurement error of the WHO-5 questionnaire was observed. Further research is recommended to explore these findings.

Background Patient-reported Outcome (PRO) measures may be used as the basis for out-patient follow-up. Instead of fixed appointments, patients attend follow-up based on disease-specific questionnaires filled in at home (telePRO). The questionnaire is handled in real time by a disease-specific algorithm, which assigns an outcome color reflecting clinical need. Questionnaires and algorithms are constructed in a consensus process with clinicians. We aimed to describe AmbuFlex’ telePRO solutions and the algorithm outcomes and variation, to discuss differences between patient groups, and to highlight possible applications and challenges. Methods TelePRO solutions with more than 100 processed questionnaires were included in the analysis. Data were retrieved together with data from national registers. Results From 2011 to 2021, 29 disease-specific telePRO solutions were implemented within 24 different ICD-10 groups. A total of 42,015 patients were referred and answered 171,268 questionnaires. An existing disease-specific instrument with cut-off values was available for four solutions, whereas items were selected or developed ad hoc for the other solutions. Mean age ranged from 10.7 years to 73.3 years. Mortality varied between 0 and 528 per 1000 patient years. Variations in algorithm outcomes reflected differences in patient groups and aims while different solutions within the same patient group varied little. Discussion TelePRO can be applied in diseases where PRO can be used to evaluate clinical status and needs. Questionnaires and algorithms should be adapted for the specific patient groups and clinical aims.

Background: Patient-reported outcome measures are increasingly used by clinicians to support communication in telephone- or face-to-face consultations with patients. A renal disease questionnaire has been developed, but not sufficiently evaluated through clinimetrics in clinical setting. Hence, we aimed to evaluate the content validity, construct validity and the test–retest reliability of a renal disease questionnaire to be used for clinical decision-making. Methods: A content, construct validity and test–retest reliability study was conducted in 3 nephrology outpatient clinics in Central Denmark Region, Denmark. Content validity (face validity, comprehensibility and relevance) was assessed among 8 patients and 6 clinicians. Reliability was assessed by asking outpatients with chronic kidney disease to complete the questionnaire twice. Reliability was assessed by kappa statistics and agreement by percentage. Construct validity was determined using 4 a priori defined hypotheses and comparing 2 known groups. Results: Five new domains emerged, 6 items were rephrased and 3 items were removed following the content validity test. A total of 160 patients completed the questionnaire with median 8 days (IQR 2 days) between assessments. The test–retest reliability parameters of the single items in the questionnaire were substantial to almost perfect as all the observed weighted kappa values ranged from 0.61 to 0.91, 95% CI (0.34 to 0.95). In total, 61% of the single items showed almost perfect agreement. In total, 3 of the 4 hypotheses were accepted and 44% of the items showed satisfying known-group discriminative validity. Conclusion: A renal disease questionnaire used for clinical decision-making in outpatient follow-up showed acceptable content validity and substantial to almost perfect reliability. Sufficient construct validity was not established. Incorporating the questionnaire into routine clinical practice may improve the evaluation of disease burden in patients with chronic kidney disease. Plain English summary: We ask patients with chronic kidney disease (CKD) in Central Region Denmark to complete a questionnaire before each outpatient visit. The answers they provide are used to support communication with their health care provider. A questionnaire requires testing to ensure it can accurately capture important information about patient’s symptoms and quality of life. When questionnaires are used to support communication between patients and health care professionals, they need to have good measurement properties. This means they need to be: (1) trustworthy, (2) relevant to a patient’s health condition, (3) consistent and produce stable results every time. We explored the measurement properties of a questionnaire designed to be used in the face-to face outpatient visits for patients with CKD. We found that the questionnaire captured consistent and stable results. Using this questionnaire may help health care professionals to assess the patients´ burden of symptoms with a more patient-centered approach. Potentially, the use of the questionnaire will increase the patients´ ability to cope with their symptoms and strengthen patients´ involvement in the clinical decisions concerning their treatment.

With increased survival among patients with metastatic melanoma and limited time with health care providers, patients are expected to assume a more active role in managing their treatment and care....

Patients with ovarian cancer often experience substantial health problems and side effects resulting in reduced quality of life (QoL). Different models of using patient-reported outcome measures (P...

Background: Knowledge about the long-term course of health following stroke is sparse and relies mainly on studies with short follow-up or few measurements per patient. We aimed to describe the course and analyze the determinants of the course of physical and mental health status after stroke with repeated measurements in a large population-based cohort of first time Danish stroke patients. Methods: We followed 2,414 first time stroke patients admitted to any hospital in the Central Denmark Region, Denmark, between October 1, 2008 and January 1, 2012, with five questionnaires over a 2 years period. Self-rated health was assessed by the SF-12 instrument. Information on possible clinical and patient-related determinants of self-rated health was obtained from questionnaires and national registers. The scores were analyzed at five selected fixed time-points and as well as longitudinally with mixed models. Results: The SF-12 mental component summary score (MCS) increased with 0.89 points/year (95% CI=0.6– 1.2), while the increase in the physically component summary score (PCS) did not reach statistical significance (0.13/year; 95% CI=− 0.2– 0.5). The most pronounced changes were seen in the Vitality and Role Physical SF-12 subscales, which both increased by 2.1 points/year. No statistically significant changes over time were found in the Physical Functioning and Bodily Pain subscales. Variables associated with increasing self-rated mental health (MCS) were no comorbidity, older age, male gender, and mild stroke severity. Variables associated with increasing ratings of physical health (PCS) were mild stroke severity, no comorbidity, higher educational level, and younger age. The negative impact of age increased significantly with time during the follow-up period for physical as well as mental health, while the effects of the other variables were stable over time. The results were similar in the two analytical approaches. Conclusion: In a large, geographically well-defined population of first time stroke patients, the majority of SF-12 sub-scales and the mental component score improved slightly over time. Small improvements in self-rated mental health may be observed during the first 2 years after the stroke. Stroke is a disease with long-term consequences on a wide range of health aspects. Level as well as course differ between sub-groups, and treatment of comorbidity may be an important target with respect to rehabilitation.