Remote Symptom Monitoring Using Patient-Reported Outcomes in Patients With Chronic Kidney Disease: Process Evaluation of a Randomized Controlled Trial.

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.

Recommendations to address respondent burden associated with patient-reported outcome assessment.

Patient-reported outcomes (PROs) are increasingly used in healthcare research to provide evidence of the benefits and risks of interventions from the patient perspective and to inform regulatory decisions and health policy. The use of PROs in clinical practice can facilitate symptom monitoring, tailor care to individual needs, aid clinical decision-making and inform value-based healthcare initiatives. Despite their benefits, there are concerns that the potential burden on respondents may reduce their willingness to complete PROs, with potential impact on the completeness and quality of the data for decision-making. We therefore conducted an initial literature review to generate a list of candidate recommendations aimed at reducing respondent burden. This was followed by a two-stage Delphi survey by an international multi-stakeholder group. A consensus meeting was held to finalize the recommendations. The final consensus statement includes 19 recommendations to address PRO respondent burden in healthcare research and clinical practice. If implemented, these recommendations may reduce PRO respondent burden.

Patient-reported outcome measures as determinants for the utilization of health care among outpatients with epilepsy: a prognostic cohort study.

BACKGROUND: Patient-reported outcome (PRO) measures can inform clinical decision making and planning of treatment in the health care system. The aim of this study was to examine whether patient-reported health domains influence the use of health care services in outpatients with epilepsy. METHODS: This was a prognostic cohort study of 2,426 epilepsy outpatients referred to PRO-based follow-up at the Department of Neurology, Aarhus University Hospital, Denmark. Patients filled out a questionnaire covering health literacy areas, self-efficacy, well-being and general health. The main outcome was a record of contact to the epilepsy outpatient clinic, inpatient ward and/or emergency room within 1 year, retrieved from health register data. Associations were analysed by multivariable binomial logistic regression. RESULTS: A total of 2,017 patients responded to the questionnaire and 1,961 were included in the final analyses. An outpatient contact was more likely among patients with very low health literacy ('social support'): odds ratio (OR) 1.5 (95% CI: 1.1-2.1), very low and low self-efficacy: OR 1.7 (95% CI: 1.2-2.3) and OR 1.4 (95% CI: 1.0-1.8), low and medium well-being: OR 2.2 (95% CI: 1.6-3.0) and OR 1.4 (95% CI: 1.1-1.9), and patients rating their general health as fair: OR 2.8 (95% CI: 1.7-4.6). Inpatient contact and emergency room contact were associated with the health domains of self-efficacy and general health. CONCLUSIONS: PRO questionnaire data indicated that patients with low health literacy ("social support"), well-being, self-efficacy and self-rated general health had an increased use of health care services at 1 year.These results suggest that PRO measures may provide useful information in relation to the possibility of proactive efforts and prevention of disease-related issues and to help identify efficiency options regarding resource utilization.

The use of patient reported outcomes (PRO) measures to monitor and plan treatment in health care has become increasingly common in recent years. In this study, we examined whether PRO measures of patients self-perceived levels of health knowledge, confidence in managing their health, overall sense of well-being, and general perception of their health could predict the need for contact in an epilepsy outpatient clinic during a 12 months' period. An outpatient contact was more likely among patients with lower levels of health literacy, well-being, self-efficacy and self-rated general health. The study indicates that PRO measures may hold useful information to inform clinical decision making and planning of care among outpatients with epilepsy.

Levels of health literacy among people living with HIV in outpatient care: a cross-sectional study from Denmark.

BACKGROUND: Low health literacy (HL) among people living with HIV (PLWHIV) encounter more disease related complications, more difficulty understanding health-related information and low adherence. Considering that, the HL levels among PLWHIV needs to be further investigated. The objective of this study was to investigate the levels of HL and patient involvement among PLWHIV in an outpatient clinic in Denmark. A second objective was to examine differences in HL levels across socio-demographic characteristics. METHODS: In 2019, a population of 682 PLWHIV from a Danish outpatient hospital clinic were enrolled in cross-sectional study. Patients who had a digital postbox received an electronic questionnaire including following domains; health literacy, patient involvement, and socio-demographic status. Health literacy was measured using the Health Literacy Questionnaire (HLQ) through scores on three subscales: social support for health (HLQ4), engaging with healthcare providers (HLQ6), and understanding health information (HLQ9). An unpaired t-test was used to investigate mean differences in the HLQ scores across socio-demographic variables. RESULTS: A total of 338 (55%) patients responded to the questionnaire. The included participants demonstrated high levels of HLQ4 (mean = 4.2) and HLQ6 (mean = 4.2), but lower for HLQ9 (mean = 2.9). In total 70-80% reported being involved in decisions about their health. We found a positive association between high level of HL (HLQ9) and living with a partner and higher levels of HL (HLQ4, HLQ6, and HLQ9) and employment. CONCLUSION: PLWHIV in a Danish out-patient care population were found to have high levels of HL despite differences in demographic characteristics. Further research is needed to examine the levels of HL among non-responders to develop HL approaches and strategies to meet the needs of individuals with different HL skills.

The national implementation of a triage algorithm based on patient-reported outcome measures in outpatients with epilepsy.

This is a letter to the editor on the article "Limited value of a patient-reported triage algorithm in an outpatient epilepsy clinic" Dan Med J 2022;69(7):A12210915.

Reducing the pressures of outpatient care: the potential role of patient-reported outcomes.

The global demand for hospital treatment exceeds capacity.The COVID-19 pandemic has exacerbated this issue, leading to increased backlogs and longer wait times for patients. The amount of outpatient attendances undertaken in many settings is still below pre-pandemic levels and this, combined with delayed referrals, means that patients are facing delays in treatment and poorer health outcomes. Use of digital health technologies, notably the use of remote symptom monitoring systems based on patient-reported outcomes (PROs), may offer a solution to reduce outpatient waiting lists and tailor care to those in greatest need. Drawing on international examples, the authors explore the use of electronic PRO systems to triage clinical care. We summarise the key benefits of the approach and also highlight the challenges for implementation, which need to be addressed to promote equitable healthcare delivery.

Flexible patient-reported outcome-based telehealth follow-up for type 1 diabetes: A qualitative study.

BACKGROUND: Successful diabetes management requires collaboration between patients and healthcare professionals and should be aligned with an individual's condition and resources. We developed a flexible, individualised, patient-reported outcome (PRO)-based telehealth intervention called "DiabetesFlex Care" in which patients completed an annual self-reported questionnaire from home, one required face-to-face appointment, and two optional outpatient consultations. In this study, we investigated patients' experiences using DiabetesFlex Care. METHODS: We conducted a qualitative, interpretive descriptive (ID) study based on semi-structured interviews with a purposeful sample of 36 patients with type 1 diabetes (T1D) who had used DiabetesFlex Care. Recorded audio data were transcribed and analysed inductively using the constant comparative method. RESULTS: DiabetesFlex Care changed participants' perspectives on living with diabetes. Patients became more involved in their own care and found that DiabetesFlex Care helped to make their conversations with healthcare professionals more relevant. Furthermore, participants appreciated the ability to both choose the format of their appointments (face-to-face vs. phone call) and cancel unnecessary appointments. CONCLUSION: DiabetesFlex Care was a flexible and inclusive health service that enabled patients to take more responsibility for their own diabetes management. The questionnaire-based approach in DiabetesFlex Care can help healthcare professionals systematically account for patients' perspectives and support user involvement and self-management. By extension, this approach can also help minimise healthcare-related disruptions in patients' lives. Further studies are needed to determine whether flexible PRO-based telehealth is an acceptable solution for all patients.

Patient-reported outcome (PRO) measurements in chronic and malignant diseases: ten years' experience with PRO-algorithm-based patient-clinician interaction (telePRO) in AmbuFlex.

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.

Hydroflex: Use of Patient Reported Outcomes in a Clinical Setting Among Patients with Hydrocephalus.

OBJECTIVE/BACKGROUND: A patient-reported outcome (PRO) measure is defined as "any report of the status of a patient's health condition that comes directly from the patient without interpretation of the patient's response by a clinician or anyone else". PRO data are increasingly being used in health care to facilitate monitoring of symptoms, facilitate communication between patients and clinicians, facilitate early identification of problems, and reduce unnecessary outpatient appointments for stable patients. METHODS: We have designed a PRO system specifically for hydrocephalus, a program named Hydroflex. The aim of Hydroflex is to use PRO measures to decide the need for clinical attention and let the patients report their need regarding a physical consultation. Patients receive questionnaires at home instead of having prescheduled appointments at the outpatient clinic. Based on an automated algorithm, the patients' PRO measures are ranked to help clinical decision-making. RESULTS: In this paper, we describe the implementation and early experience of Hydroflex at our institution. CONCLUSIONS: It is our belief that Hydroflex provides more continuity in the treatment of patients with hydrocephalus. Also, it provides for a more standardized follow-up scheme, and we postulate this will lead to improved patient satisfaction and involvement and fewer outpatient appointments. Also, Hydroflex is useful for quality control and prospective research.

Measures used to assess interventions for increasing patient involvement in Danish healthcare setting: a rapid review.

OBJECTIVE: To identify measures used within Denmark evaluating any type of intervention designed to facilitate patient involvement in healthcare. DESIGN: Environmental scan employing rapid review methods. DATA SOURCES: MEDLINE, PsycInfo and CINAHL were searched from 6-9 April 2021 from database inception up to the date of the search. ELIGIBILITY CRITERIA: Quantitative, observational and mixed methods studies with empirical data on outcomes used to assess any type of intervention aiming to increase patient involvement with their healthcare. Language limitations were Danish and English. DATA EXTRACTION AND SYNTHESIS: Two independent reviewers extracted data from 10% of the included studies and, due to their agreement, the data from the rest were extracted by first author. Data were analysed with reference to existing categories of measuring person-centred care; findings were synthesised using narrative summaries. Adapted Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines were used to guide reporting. RESULTS: Among 3767 records, 43 studies met the inclusion criteria, including 74 different measures used to evaluate interventions aimed at increasing patient involvement within healthcare in Danish hospital and community settings. Generic measures assessed: patient engagement (n=3); supporting self-management (n=8); supporting shared decision-making (n=9); patient satisfaction and experiences of care (n=11); health-related patient-reported outcome (n=20). CONCLUSIONS: Across Denmark, complex interventions designed to improve patient involvement with healthcare vary in their goals and content. Some targeting healthcare professionals, some patient health literacy and some service infrastructure. A plethora of measures assess the impact of these interventions on patient, professional and service delivery outcomes. Few measures assessed patient involvement directly, and it is unclear which proxy measures capture indicators of perceived involvement. Lack of conceptual clarity between intervention goals, the components of change and measures makes it difficult to see what types of intervention can best support change in services to ensure patients are more effectively involved in their healthcare.

Test-retest reliability and measurement error of the WHO-5 Well-being Index and the Problem Areas in Diabetes questionnaire (PAID) used in telehealth among patients with type 1 diabetes.

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.

Randomized controlled study to evaluate the impact of flexible patient-controlled visits in people with type 1 diabetes: The DiabetesFlex Trial.

AIM: The objective of this study was to assess the impact of health care-initiated visits versus patient-controlled flexible visits on clinical and patient-reported outcomes in people with type 1 diabetes. METHODS: The DiabetesFlex trial was a randomized controlled, pragmatic non-inferiority 15-month follow-up study comparing standard care (face-to-face visits every 4 months) with DiabetesFlex (patient-controlled flexible visits using patient-reported, outcome-based telehealth follow-up). Of 343 enrolled participants, 160 in each group completed the study. The primary outcome was mean change in HbA1c from baseline to 15-month follow-up. Secondary outcomes were blood pressure, lipid levels, frequency of visits, the World Health Organization score-five well-being-index (WHO-5), the Problem Areas In Diabetes (PAID) scale and experience of participation in own care (participation score). RESULTS: The adjusted mean difference in HbA1c between standard care and DiabetesFlex was similar and below the predefined non-inferiority margin of 0.4% (-0.03% [95%CI: 0.15, 0.11]/-0.27 mmol/mol [-1.71, 1.16]). No intergroup mean changes in lipid or blood pressure were observed. Conversely, DiabetesFlex participants presented an increased mean WHO-5 index of 4.5 (1.3, 7.3), participation score of 1.1 (0.5, 2.0), and decreased PAID score of -4.8 (-7.1, -2.6) compared with standard care. During follow-up, DiabetesFlex participants actively changed 23% of face-to-face visits to telephone consultations, cancelled more visits (17% vs. 9%), and stayed away without cancellation less often (2% vs. 8%). CONCLUSION: Compared with standard care, flexible patient-controlled visits combined with patient-reported outcomes in participants with metabolic controlled type 1 diabetes and good psychological well-being further improved diabetes-related well-being and decreased face-to-face visits while maintaining safe diabetes management.

Patient-reported outcome measures for clinical decision-making in outpatient follow-up: validity and reliability of a renal disease questionnaire.

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. 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.

Patient-reported outcome measures in the emergency department: a scoping review protocol.

OBJECTIVE: The objective of this scoping review is to identify and characterize validated patient-reported outcome measures used to assess adult patients' health status in the emergency department to support clinical decision-making and to develop individual care and treatment plans. INTRODUCTION: In recent years, the workload in emergency departments has increased and patient management is characterized by a fast pace. The accelerated approach may lead to unintentional negligence by health care professionals of patient-reported signs and symptoms in the emergency department. Thus, use of patient-reported outcome measures in the emergency department may improve health care professionals' attention to the needs and health status of patients. INCLUSION CRITERIA: Studies assessing adult patients' health status in the emergency department using patient-reported outcome measures will be considered. The patient-reported outcome measures should be self-reported, assisted by a proxy, or administered through interviews. Only studies reporting on the measurement properties of patient-reported outcome measures will be included. Moreover, health-related information retrieved using patient-reported outcome measures should be applicable at an individual patient level. METHODS: A systematic literature search will be performed primarily in the databases MEDLINE, Embase, CINAHL, and PsycINFO. Both published and unpublished sources of information will be considered. Studies published from 2000 onwards in Danish, Swedish, Norwegian, German, and English will be included. Using the JBI methodology for scoping reviews, two reviewers will independently perform the study selection and data extraction. The results will be presented in a tabular form together with a narrative summary.

Patient-reported outcome measures in the interaction between patient and clinician - a multi-perspective qualitative study.

BACKGROUND: This article addresses patient-reported outcome (PRO)-based follow-up used as a substitute for regularly scheduled follow-ups. In PRO-based follow-up, patients' PRO data filled in by the patients at home are used by clinicians as a decision aid to identify those who need clinical attention based on an automated PRO algorithm, clinical attention being either a phone call or a physical consultation. A physical consultation in the outpatient clinic prompted by the patient's PRO is termed a "PRO consultation." In this multi-perspective qualitative study, we explored the influence of patients' self-reported data on patient-clinician interaction during PRO consultations in epilepsy outpatient clinics. Interpretive description was the methodological approach, applying data from participant observations, informal interviews with clinicians, and semi-structured interviews with clinicians and patients. RESULTS: We found that application and deliberate use of patients' PRO measures can affect patient-clinician interaction, promoting patient involvement in terms of improved communication and increased patient activation. These findings reflect the general patterns that have been reported in the literature. In addition, we found that PRO measures also may induce unmet expectations among some patients that can have a negative effect on patients' experiences of the interaction and their follow-up experience in general. We extracted two thematic patterns that represent PRO measures' potential for patient involvement in the patient-clinician interaction. The first pattern represents enablers, and the second pattern represents barriers for PRO measures to affect patient involvement. CONCLUSIONS: Applying PRO measures in clinical practice does not automatically enhance the patient-clinician interaction. To strengthen the benefits of PRO measures, the following supplementary clinical initiatives are suggested: summarizing and reporting the PRO measures back to the patient, considering carefully which PRO measures to include, training clinicians and assuring that the patients' introduction to PRO-based follow-up clarifies expectations.

Sociodemographic, personal, and disease-related determinants of referral to patient-reported outcome-based follow-up of remote outpatients: a prospective cohort study.

PURPOSE: We examined the association between sociodemographic, personal, and disease-related determinants and referral to a new model of health care that uses patient-reported outcomes (PRO) measures for remote outpatient follow-up (PRO-based follow-up). METHODS: We conducted a prospective cohort study among outpatients with epilepsy at the Department of Neurology at Aarhus University Hospital, Denmark. Included were all persons aged ≥ 15 years visiting the department for the first time during the period from May 2016 to May 2018. Patients received a questionnaire containing questions about health literacy, self-efficacy, patient activation, well-being, and general health. We also collected data regarding sociodemographic status, labour market affiliation, and co-morbidity from nationwide registers. Associations were analysed as time-to-event using the pseudo-value approach. Missing data were handled using multiple imputations. RESULTS: A total of 802 eligible patients were included in the register-based analyses and 411 patients (51%) responded to the questionnaire. The results based on data from registers indicated that patients were less likely to be referred to PRO-based follow-up if they lived alone, had low education or household income, received temporary or permanent social benefits, or if they had a psychiatric diagnosis. The results based on data from the questionnaire indicated that patients were less likely to be referred to PRO-based follow-up if they reported low levels of health literacy, self-efficacy, patient activation, well-being, or general health. CONCLUSION: Both self-reported and register-based analyses indicated that socioeconomically advantaged patients were referred more often to PRO-based follow-up than socioeconomically disadvantaged patients.

Patient-initiated versus fixed-interval patient-reported outcome-based follow-up in outpatients with epilepsy: a pragmatic randomized controlled trial.

BACKGROUND: The use of patient-reported outcome (PRO) could potentially contribute to the reorganization of the health care system. AmbuFlex is a PRO system used in remote patient monitoring, in which questionnaires are sent to patients at fixed intervals. The PRO data are used by clinicians to decide whether patients need clinical attention. Better self-management and cost-saving follow-up activities may be achieved by letting patients initiate need of contact. We evaluated the effects of patient-initiated PRO-based outpatient follow-up on health care resource utilization, quality of care, and the patient perspective. METHODS: We conducted a parallel two-arm pragmatic randomized controlled trial at the Department of Neurology, Aarhus University Hospital, Denmark. Outpatients with epilepsy (≥ 15 years old), attending fixed-interval PRO-based follow-up with web-based questionnaires, were randomly assigned in a ratio of 0.55:0.45 to either 1) patient-initiated PRO-based follow-up (open access telePRO) or 2) fixed-interval PRO-based follow-up (standard telePRO). The primary outcome was the number of outpatient hospital contacts related to epilepsy retrieved from a regional registry. Hospitals admissions and emergency room visits were also assessed. Secondary self-reported outcomes including general health, well-being, health literacy, self-efficacy, number of seizures, side effects, confidence, safety, and satisfaction were retrieved from questionnaires. Data were analyzed by the intention-to-treat and per-protocol approaches. RESULTS: Between January 2016 and July 2016, 593 patients were randomized to either open access telePRO (n = 346) or standard telePRO (n = 247). At 18 months, no statistically significant differences were found between the arms regarding number of telephone consultations or outpatient visits. Patients in the open access arm had a slightly lower, statistically significant number of emergency room visits than patients in the standard arm. Self-reported mental well-being in the open access arm was slightly, statistically significantly lower than in the standard arm. Other secondary outcomes did not differ statistically significantly between arms. CONCLUSION: This study did not find, as hypothesized, less use of health care resources or improved patient self-management or satisfaction in the patient-initiated PRO-based initiative compared to fixed-interval PRO-based follow-up. Patient-initiated PRO-based follow-up may be used as an alternative to fixed-interval PRO-based follow-up in patients who prefer this approach, but there is insufficient evidence for recommending a system-wide shift to patient-initiated PRO-based follow-up. TRIAL REGISTRATION: Registered 4 February 2016 with ClinicalTrials.gov: NCT02673580 .

Test-retest reliability and measurement error of the Danish WHO-5 Well-being Index in outpatients with epilepsy.

BACKGROUND: The generic questionnaire WHO-5 Well-being Index (WHO-5), which measures the construct of mental well-being has been widely used in several populations across countries. The questionnaire has demonstrated sufficient psychometric properties; however, the test- retest reliability of the WHO-5 scale has yet to be determined. The aim of this study was to evaluate the test-retest reliability and measurement error of the Danish WHO-5 Well-being Index for outpatients with epilepsy. A further aim was to evaluate whether the method of administration (web, paper, or a mixture of the two modalities) influenced the results. METHODS: Epilepsy outpatients aged ≥15 years from three outpatient clinics in Central Denmark Region were included from August 2016 to April 2017. The participants were randomly divided into four test-retest groups: web-web, paper-paper, web-paper, and paper-web. Test-retest reliability was assessed by intraclass correlation coefficients (ICC) and measurement error by calculating minimal detectable change (MDC) on the basis of the standard error of the measurement. RESULTS: A total of 554 patients completed the questionnaire at two time points. The median duration between test-retest was 22 days. The pooled test-retest reliability estimate was ICC 0.81 (95% CI 0.78; 0.84). The estimated MDC was 23.60 points (95% CI 22.27; 25.10). These estimates showed little variation across administration methods. CONCLUSIONS: WHO-5 showed acceptable test-retest reliability in a Danish epilepsy outpatient population across different method of administration; however, the relatively large measurement error should be taken into account when evaluating changes in WHO-5 scores over time. Further research should be done to explore these findings.