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.

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.

Effect of patient-reported outcomes as a dialogue-based tool in cancer consultations on patient self-management and health-related quality of life: a clinical, controlled trial.

BACKGROUND: 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. Activated patients have the knowledge, skills, and confidence to make effective solutions to self-manage health. The use of patient-reported outcomes (PRO) could have the potential to enhance patient activation. However, PRO-based interventions that facilitate an activation in patients with metastatic melanoma are lacking and warranted. MATERIAL AND METHODS: In this prospective non-randomized controlled, clinical trial, patients with metastatic melanoma were assigned to either the intervention (systematic feedback and discussion of PRO during consultation) given at one hospital or the control group (treatment as usual) if they received treatment from two other hospitals in Denmark. The primary outcome was the patient activation measure (PAM), which reflects self-management. Secondary outcomes were health-related quality of life (HRQoL), self-efficacy, and Patient-Physician interaction. Outcomes were measured at baseline, and after 3, 6, and 12 months. The analysis of the effect from baseline to 12 months employed mixed-effects modeling. RESULTS: Between 2017 and 2019, patients were allocated to either the intervention group (n = 137) or the control group (n = 142). We found no significant difference in the course of patient activation between the two groups over time. The course of HRQoL was statistically significantly improved by the intervention compared to the control group. Especially, females in the intervention group performed better than males. The other secondary outcomes were not improved by the intervention. CONCLUSION: The intervention did not improve knowledge, skills, and confidence for self-management for patients with metastatic melanoma. Neither did it improve coping self-efficacy nor perceived efficacy in Patient-Physician interaction. However, the results suggest that the intervention can have a significant impact on HRQoL and in particular social and emotional well-being among the females.

The PROMova study comparing active and passive use of patient-reported outcome measures in ovarian cancer follow-up: effect on patient-perceived involvement, satisfaction with care, and usefulness.

BACKGROUND: 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 (PROMs) during follow-up may improve the quality of care. This national, multicenter observational study investigated the effect of active use of PROMs on patient-perceived involvement, satisfaction with care, unmet needs, and QoL during follow-up of ovarian cancer. MATERIAL AND METHODS: Ovarian cancer patients were recruited at the end of primary treatment at eight centers in Denmark. During 18 months of follow-up patients repeatedly completed European Organization for Research and Treatment of Cancer (EORTC) questionnaires covering health related QoL and symptoms. At the sites using PROMs actively (ACT), the clinician had access to an overview of the patient's scores during the clinical encounter. Clinicians using PROMs passively were alerted in case of severe development of symptoms. Following each encounter, patients evaluated their health service experience by completing the CollaboRATE scale of involvement in decision making, the Patient Experience Questionnaire, and ad hoc questions covering patient-perceived usefulness of the PROMs. RESULTS: A total of 223 patients were enrolled, i.e., 168 (75.3%) at five sites using ACT and 53 (23.8%) at three sites using them passively. We found no statistically significant difference in involvement in the decision making, satisfaction with care, unmet needs, and QoL between the two groups. The majority of patients found it useful to complete the PROMs, although it did not seem to significantly support them in raising issues with the oncologist. CONCLUSION: Active use of PROMs did not improve patients' experience of involvement in follow-up care as compared to passive use.

Association of patient-reported outcomes and ovarian cancer recurrence.

BACKGROUND: The vast majority of patients with advanced ovarian cancer experience disease recurrence after primary treatment. OBJECTIVE: To explore the diagnostic accuracy of repeated measurement of patient-reported outcomes and quality-of-life scores in relation to ovarian cancer recurrence. METHODS: Patients with ovarian cancer were recruited to the PROMova study by the end of their primary treatment at eight centers in Denmark. The purpose of the PROMova study was to explore the applicability of repeated use of patient-reported outcomes, which consisted of the European Organization for Research and Treatment of Cancer generic questionnaire and the ovarian specific questionnaire. The patient-reported outcomes were completed 3, 6, 9, 12, and 15 months after enrollment or until recurrence. The 3-month interval between completions was the period in which recurrence was assessed. Imaging and the biomarker CA125 were used as reference modality for recurrence. Mixed effects logistic regression was used to investigate the association between mean patient-reported outcome scores and recurrence. Receiver operating curves were used to establish cut-off scores. The diagnostic accuracy of patient-reported outcomes, including sensitivity, specificity, and positive and negative predictive values was estimated based on the Youden index. For combined scales, diagnostic accuracy was investigated based on multivariate analysis. RESULTS: The analysis included 196 patients with an overall recurrence rate of 50.5% and an overall mean time to recurrence of 302 days. With imaging as reference, patients with recurrence reported significantly lower global health, worse physical functioning, and more abdominal symptoms preceding recurrence. With CA125 as reference, global health, physical and emotional functioning were impaired. Despite the worsening of a number of symptoms prior to recurrence whichever reference modality was applied, the patient-reported outcome scores did not provide adequate diagnostic accuracy. CONCLUSION: Repeated use of patient-reported outcomes during surveillance of ovarian cancer was not of diagnostic value. Future efforts should be directed at improving the administration of patient-reported outcomes as well as exploring the potential of using these outcomes as an indicator of clinical relevance.

Electronic reporting of patient-reported outcomes in a fragile and comorbid population during cancer therapy - a feasibility study.

BACKGROUND: Electronic collection of patient-reported outcomes (ePROs) is becoming widespread in health care, but the implementation into routine cancer care during therapy remains to be seen. Especially, little is known of the use and success of electronic reporting during active cancer treatment in fragile and comorbid patients. The aim of this study was to test the feasibility of ePRO and its incorporation into routine cancer care, measured by physician compliance, for a fragile and comorbid bladder cancer (BC) population receiving chemo- or immunotherapy. METHODS: All BC patients initiating treatment for locally advanced or metastatic bladder cancer at Rigshospitalet or Herlev Hospital, Denmark, were approached during an 8 month period. Exclusion criteria were patients not speaking Danish or not being signed up for electronic communication with health authorities. Enrolled patients were prompted to complete weekly ePROs from home. Patients completed the European Organisation for Research and Treatment of Cancer's general quality of life questionnaire, QLQ-C30, and the module for muscle-invasive bladder cancer QLQ-BLM30, the Hospital Anxiety and Depression Scale, HADS, and selected items from the Patient Reported-Outcomes version of the Common Terminology Criteria of Adverse Events (PRO-CTCAE), in total 158 questions weekly. If failing to report when prompted, patients were sent two e-mail reminders. Patients were informed that the physician would have an overview of the reported ePROs at their following clinical visits. Physicians were at all clinical visits informed to look at the ePROs in a software solution separate from the medical records. Physicians were logged to check their compliance to the task. No continuous surveillance of ePROs was established. RESULTS: Of 91 patients screened for enrolment, 19 patients (21%) were not found eligible for standard treatment, eight patients (9%) were not signed up for electronic communication with the health authorities and nine patients (10%) declined participation. Another six patients did not meet other inclusion criteria. In total 49 BC patients were enrolled, 29 initiating chemotherapy and 20 initiating immunotherapy. A total of 466 electronic questionnaires were completed. The overall adherence of the patients to complete ePROs was at an expected level for an elderly cancer population (75%) and remained above 70% until the 6th cycle of treatment. The physician' compliance was in contrast low (0-52%) throughout the course of treatment. CONCLUSIONS: Electronic reporting of PROs is feasible in a fragile and comorbid population of patients during routine active cancer treatment. Despite clear implementation strategies the physician compliance remained low throughout the study proving the need for further implementation strategies.

Use of PROM during follow-up of patients with ovarian cancer: the PROMova study protocol.

BACKGROUND: There is a paucity of high-level evidence on the optimal follow-up of patients with ovarian cancer after primary treatment. A debate is ongoing on the extent to which follow-up should consider patient preferences and patient-reported outcome measures. Incorporation of patient-reported outcome measures supports the dialog between patient and clinician and may be instrumental in symptom monitoring and detection of underlying issues, especially when used actively during the clinical consultation. PRIMARY OBJECTIVE AND ENDPOINT: The PROMova study aims to assess whether proactive use of patient-reported outcome measures during follow-up care increases patient involvement as perceived by the patient compared with standard care. Another objective is to measure satisfaction with the care provided. STUDY HYPOTHESIS: It is hypothesized that proactive use of patient-reported outcome measures during the clinical encounter will improve patients' experience of involvement in follow-up care. TRIAL DESIGN: PROMova is a multi-center, observational cohort study collecting data from eight departments in Denmark. Five departments use the patient-reported outcome measures proactively during the consultation and three provide standard care. Participants are followed up with patient-reported outcome measures for up to 3 years. The patient-reported outcome measures package comprises EORTC QLQ-C30, EORTC QLQ-OV28, a questionnaire screening tool for recurrence, CollaboRATE, and selected questions from the Patient Experience Questionnaire. MAJOR INCLUSION/EXCLUSION CRITERIA: Patients older than 18 years diagnosed with ovarian, fallopian tube, or primary peritoneal cancer are eligible when entering the follow-up program after primary treatment. Participants must be able to speak and read Danish. SAMPLE SIZE: 223 patients with ovarian cancer. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The protocol closed for enrollment in 2019. Publication of final results is expected in spring 2022. TRIAL REGISTRATION: PROMova was registered with ClinicalTrials.gov November 2016 Identifier: NCT02916875.

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.

Remote follow-up using patient-reported outcome measures in patients with chronic kidney disease: the PROKID study - study protocol for a non-inferiority pragmatic randomised controlled trial.

BACKGROUND: Outpatient care is steadily changing from hospital consultations to other platforms, such as phone consultation and online virtual clinics. It is prudent to maintain quality of care with such initiatives. Currently, patients with chronic kidney disease (CKD) have frequent scheduled visits, but it may be possible to optimise the frequency of hospital consultations using information from patient-reported outcome (PRO) questionnaires filled in at home (PRO-based follow-up). This approach may provide a more individually tailored follow-up based on actual needs for clinical attention. We aimed to evaluate the effectiveness of the quality of care, use of resources and patient outcomes associated with PRO-based follow-up in patients with CKD. METHODS: This study is a pragmatic, non-inferiority, randomised controlled trial in outpatients with CKD (Grove BE et al., Qual Life Res 27: S143, 2018). Newly referred patients with an estimated glomerular filtration rate (eGFR) of ≤40 ml/min 1.73m2 will be randomised to either: 1. PRO-based remote follow-up 2. PRO-based telephone consultation 3. Usual outpatient follow-up (control group) In the two intervention groups, a diagnosis-specific PRO questionnaire completed by the patient at home will substitute for usual outpatient follow-up visits. The PRO questionnaire will in part be used as a screening tool to identify patients in need of outpatient contact and to identify focus areas. Responses from the questionnaire will be processed according to a disease-specific algorithm and assigned green, yellow or red status according to patients' needs. The primary outcome will be loss of renal function evaluated by eGFR. Secondary outcomes are 1. Clinical outcomes, including initiation of acute dialyses, hospitalisation and mortality, 2. Utilisation of healthcare resources and 3. PRO measures, primarily quality of life (Euroqol EQ-5D) and illness perception (Brief Illness Perception Questionnaire (BIPQ). DISCUSSION: Benefits and possible drawbacks of the PRO-based follow-up will be evaluated. If PRO-based follow-up proves non-inferior to usual outpatient follow-up, a reorganisation of routine clinical practice in nephrology outpatient clinics may occur. Further, results may impact other patient groups with chronic conditions attending regular follow-up. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03847766 (Retrospectively registered on January 23, 2019).

Fifteen Years' Use of Patient-Reported Outcome Measures at the Group and Patient Levels: Trend Analysis.

BACKGROUND: Since 2004, we have collected patient-reported outcome (PRO) data from several Danish patient populations for use at the group and patient levels. OBJECTIVE: The aim of this paper is to highlight trends during the last 15 years with respect to patient inclusion, the methods for collection of PRO data, the processing of the data, and the actual applications and use of the PRO measurements. METHODS: All PRO data have been collected using the AmbuFlex/WestChronic PRO system, which was developed by the author in 2004 and has been continuously updated since. The analysis of trends was based on a generic model applicable for any kind of clinical health data, according to which any application of clinical data may be divided into four processes: patient identification, data collection, data aggregation, and the actual data use. Data for analysis were generated by a specific application in the system and transferred for analysis to the R package. RESULTS: During the 15-year period, 78,980 patients within 28 different groups of chronic and malignant illnesses have answered 260,433 questionnaires containing a total of 13,538,760 responses. Several marked changes have taken place: (1) the creation of cohorts for clinical epidemiological research purposes has shifted towards cohorts defined by clinical use of PRO data at the patient level; (2) the development of AmbuFlex, where PRO data are used as the entire basis for outpatient follow-up instead of fixed appointments, has undergone exponential growth and the system is currently in use in 47 International Statistical Classification of Diseases and Related Health Problems groups, covering 16,000 patients and 94 departments throughout Denmark; (3) response rates (up to 92%) and low attrition rates have been reached in group level projects, and there are even higher response rates in AmbuFlex where the patients are individually referred; (4) The answering method has shifted, as while in 2005 a total of 66.5% of questionnaires were paper based, this is the case for only 4.3% in 2019; and (5) the approach methods for questionnaires and reminders have changed dramatically from letter, emails, and short message service text messaging to a national, secure electronic mail system through which 93.2% of the communication to patients took place in 2019. The combination of secure email and web-based answering has resulted in a low turnaround time in which half of responses are now received within 5 days. CONCLUSIONS: The demand for clinical use of PRO measurements has increased, driven by a wish among patients as well as clinicians to use PRO to promote better symptom assessment, more patient-centered care, and more efficient use of resources. Important technological changes have occurred, creating new opportunities, and making PRO collection and use cheaper and more feasible. Several legal changes may constitute a barrier for further development as well as a barrier for better utilization of patients' questionnaire data. The current legal restrictions on the joint use of health data imposed by the European Union's General Data Protection Regulation makes no distinction between use and misuse, and steps should be taken to alleviate these restrictions on the joint use of PRO data.

Health Data Processes: A Framework for Analyzing and Discussing Efficient Use and Reuse of Health Data With a Focus on Patient-Reported Outcome Measures.

The collection and use of patient health data are central to any kind of activity in the health care system. These data may be produced during routine clinical processes or obtained directly from the patient using patient-reported outcome (PRO) measures. Although efficiency and other reasons justify data availability for a range of potentially relevant uses, these data are nearly always collected for a single specific purpose. The health care literature reflects this narrow scope, and there is limited literature on the joint use of health data for daily clinical use, clinical research, surveillance, and administrative purposes. The aim of this paper is to provide a framework for discussing the efficient use of health data with a specific focus on the role of PRO measures. PRO data may be used at an individual patient level to inform patient care or shared decision making and to tailor care to individual needs or group-level needs as a complement to health record data, such as that on mortality and readmission, in order to inform service delivery and measure the real-world effectiveness of treatment. PRO measures may be used either for their own sake, to provide valuable information from the patient perspective, or as a proxy for clinical data that would otherwise not be feasible to collect. We introduce a framework to analyze any health care activity that involves health data. The framework consists of four data processes (patient identification, data collection, data aggregation and data use), further structured into two dichotomous dimensions in each data process (level: group vs patient; timeframe: ad hoc vs systematic). This framework is used to analyze various health activities with respect to joint use of data, considering the technical, legal, organizational, and logistical challenges that characterize each data process. Finally, we propose a model for joint use of health data with data collected during follow-up as a base. Demands for health data will continue to increase, which will further add to the need for the concerted use and reuse of PRO data for parallel purposes. Repeated and uncoordinated PRO data collection for the same patient for different purposes results in misuse of resources for the patient and the health care system as well as reduced response rates owing to questionnaire fatigue. PRO data can be routinely collected both at the hospital (from inpatients as well as outpatients) and outside of hospital settings; in primary or social care settings; or in the patient's home, provided the health informatics infrastructure is in place. In the future, clinical settings are likely to be a prominent source of PRO data; however, we are also likely to see increased remote collection of PRO data by patients in their own home (telePRO). Data collection for research and quality surveillance will have to adapt to this circumstance and adopt complementary data capture methods that take advantage of the utility of PRO data collected during daily clinical practice. The European Union's regulation with respect to the protection of personal data-General Data Protection Regulation-imposes severe restrictions on the use of health data for parallel purposes, and steps should be taken to alleviate the consequences while still protecting personal data against misuse.

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.

Exploring organisational mechanisms in PRO-based follow-up in routine outpatient care - an interpretive description of the clinician perspective.

BACKGROUND: Patient-reported outcome (PRO)-based follow-up is a new model of service delivery, where PRO measures are used as the very basis for demand-driven outpatient follow-up in patients with chronic diseases. Adopting the clinicians' perspective, we aimed to explore what happens when PRO-based follow-up is implemented in routine clinical practice. We also aimed to identify organisational mechanisms related to PRO-based follow-up. METHODS: The methodological approach of this interview study is interpretive description, informed by a perspective of critical realism. Semi-structured interviews were conducted with 13 clinicians (eight nurses and five physicians) working with PRO-based follow-up in outpatient care for epilepsy in the Central Denmark Region. RESULTS: PRO-based follow-up gave rise to ambivalence in clinicians. Seen from the clinicians' perspective, PRO-based follow-up could both increase and decrease the quality of follow-up. Moreover, PRO-based follow-up both enhanced and impaired clinicians' work experiences. Additionally, the clinicians used strategies to ease some of the perceived disadvantages. The clinicians did extra tasks and worked around the scope of PRO-based follow-up. Thus, clinicians constituted a professional buffer as they deflected some of the negative mechanisms associated with PRO-based follow-up. CONCLUSIONS: As a model of a service delivery, PRO-based follow-up is highly dependent on the clinicians' day-to-day management of the system, and mechanisms related to routine use of PRO measures in outpatient follow-up are complex. Paying attention to the organisational settings is critical for PRO-based follow-up to improve quality of care and enhance patient-centred care.

Effect of patient-initiated versus fixed-interval telePRO-based outpatient follow-up: study protocol for a pragmatic randomised controlled study.

BACKGROUND: The traditional system of routine outpatient follow-up of chronic disease in secondary care may involve a waste of resources if patients are well. The use of patient-reported outcomes (PRO) could support more flexible, cost-saving follow-up activities. AmbuFlex is a PRO system used in outpatient follow-up in the Central Denmark Region. PRO questionnaires are sent to patients at fixed intervals. The clinicians use the PRO data to decide whether a patient needs a visit or not (standard telePRO). PRO may make patients become more involved in their own care pathway, which may improve their self-management. Better self-management may also be achieved by letting patients initiate contact. The aim of this study is to obtain data on the effects of patient-initiated follow-up (open access telePRO) on resource utilisation, quality of care, and the patient perspective. METHODS: The study is a pragmatic, randomised, controlled trial in outpatients with epilepsy. Participants are randomly assigned to one of two follow-up activities: a) standard telePRO or b) open access telePRO. Inclusion criteria are age ≥ 15 years and previous referral to standard telePRO follow-up at Aarhus University Hospital, Denmark. Furthermore, patients must have answered the last questionnaire via the Internet. The number of contacts will be used as the primary outcome measure. Secondary outcome measures include well-being (WHO-5 Well-Being Index), general health, number of seizures, treatment side effects, mortality, health literacy (Health Literacy Questionnaire), self-efficacy (General Self-Efficacy scale), patient activation, confidence, safety, and satisfaction. In addition, the patient perspective will be explored by qualitative methods. Data will be collected at baseline and 18 month after randomisation. Inclusion of patients in the study started in January 2016. Statistical analysis will be performed on an intention-to-treat and per-protocol basis. For qualitative data, the interpretive description strategy will be used. DISCUSSION: The benefits and possible drawbacks of the PRO-based open access approach will be evaluated. The present study will provide important knowledge to guide future telePRO interventions in relation to effect on resource utilisation, quality of care, and the patient perspective. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02673580 (Registration date January 28, 2016).

Individual Prognosis of Symptom Burden and Functioning in Chronic Diseases: A Generic Method Based on Patient-Reported Outcome (PRO) Measures.

BACKGROUND: Information to the patient about the long-term prognosis of symptom burden and functioning is an integrated part of clinical practice, but relies mostly on the clinician's personal experience. Relevant prognostic models based on patient-reported outcome (PRO) data with repeated measurements are rarely available. OBJECTIVE: The aim was to describe a generic method for individual long-term prognosis of symptom burden and functioning that implied few statistical presumptions, to evaluate an implementation for prognosis of depressive symptoms in stroke patients and to provide open access to a Web-based prototype of this implementation for individual use. METHODS: The method used to describe individual prognosis of a PRO outcome was based on the selection of a specific subcohort of patients who have the same score as the patient in question at the same time (eg, after diagnosis or treatment start), plus or minus one unit of minimal clinically important difference. This subcohort's experienced courses were then used to provide quantitative measures of prognosis over time. A cohort of 1404 stroke patients provided data for a simulation study and a prototype for individual use. Members of the cohort answered questionnaires every 6 months for 3.5 years. Depressive symptoms were assessed by the Hospital Anxiety and Depression Scale (HADS) and a single item from the SF-12 (MH4) health survey. Four approaches were compared in a simulation study in which the prognosis for each member of the cohort was individually assessed. RESULTS: The mean standard deviations were 40% to 70% higher in simulated scores. Mean errors were close to zero, and mean absolute errors were between 0.46 and 0.66 SD in the four approaches. An approach in which missing HADS scores were estimated from the single-item SF-12 MH4 performed marginally better than methods restricted to questionnaires with a genuine HADS score, which indicates that data collected with shorter questionnaires (eg, in clinical practice) may be used together with longer versions with the full scale, given that the design includes at least two simultaneous measurements of the full scale and the surrogate measure. CONCLUSIONS: This is the first description and implementation of a nonparametric method for individual PRO-based prognosis. Given that relevant PRO data have been collected longitudinally, the method may be applied to other patient groups and to any outcome related to symptom burden and functioning. This initial implementation has been deliberately made simple, and further elaborations as well as the usability and clinical validity of the method will be scrutinized in clinical practice. An implementation of the prototype is available online at www.prognosis.dk.

AmbuFlex: tele-patient-reported outcomes (telePRO) as the basis for follow-up in chronic and malignant diseases.

PURPOSE: A tele-patient-reported outcome (telePRO) model includes outpatients' reports of symptoms and health status from home before or instead of visiting the outpatient clinic. In the generic PRO system, AmbuFlex, telePRO is used to decide whether a patient needs an outpatient visit and is thus a tool for better symptom assessment, more patient-centred care, and more efficient use of resources. Specific PROs are developed for each patient group. In this paper we describe our experiences with large-scale implementations of telePRO as the basis for follow-up in chronic and malignant diseases using the generic PRO system AmbuFlex. METHODS: The AmbuFlex concept consists of three generic elements: PRO data collection, PRO-based automated decision algorithm, and PRO-based graphical overview for clinical decision support. Experiences were described with respect to these elements. RESULTS: By December 2015, AmbuFlex was implemented in nine diagnostic groups in Denmark. A total of 13,135 outpatients from 15 clinics have been individually referred. From epilepsy clinics, about 70 % of all their outpatients were referred. The response rates for the initial questionnaire were 81-98 %. Of 8256 telePRO-based contacts from epilepsy outpatients, up to 48 % were handled without other contact than the PRO assessment. Clinicians as well as patients reported high satisfaction with the system. CONCLUSION: The results indicate that telePRO is feasible and may be recommended as the platform for follow-up in several patient groups with chronic and malignant diseases and with many consecutive outpatient contacts.

Determinants of Self-Rated Health Three Months after Stroke.

OBJECTIVES: Self-rated health is an important aspect of life after stroke. The aim of this study was to compare self-rated health in a population of stroke patients to the general Danish population and to analyze to what extent clinical and patient-related factors influence self-rated health 3 months after stroke. METHODS: We sent questionnaires on self-rated health (Short Form-12 Health Survey) to all patients younger than 80 years with first-time stroke admitted to any hospital in the Central Denmark Region between October 1, 2008, and December 31, 2011 (N = 2414). Information on clinical and patient-related determinants of self-rated health was obtained from population-based national health registers. RESULTS: Compared to the general population, stroke patients rated their health lower than the general Danish population. The largest differences were found in domains of physical health, and only minor differences were identified in mental health between the study and the general Danish population. Stroke severity, comorbidity, smoking, educational level, and age were strongly associated with self-reported health. For patients with a "very severe" stroke, the adjusted odds ratios (ORs) of reduced mental health were 1.6 (95% confidence interval [CI]: 1.3-2.6) and 5.1 (95% CI: 2.7-9.6) for low physical health, compared to patients with "mild stroke." Patients with a Charlson Comorbidity Index score of 3 or higher had a higher risk of low mental health (OR 1.9 [95% CI: 1.3-2.6]) and low physical health (OR 2.8 [95% CI: 1.9-4.0]) than patients with no additive diseases. CONCLUSIONS: Stroke had a marked impact of self-rated health, particularly physical health. Higher stroke severity and level of comorbidity were important risk factors of reduced self-rated health.

Effect of Psychosocial Work Environment on Sickness Absence Among Patients Treated for Ischemic Heart Disease.

INTRODUCTION: During the last decades mortality has declined in patients with coronary heart disease due to improvements in treatments and changes in life style, resulting in more people living with chronic heart disease. This implies that focus on rehabilitation and re-integration to the work-force becomes increasingly important. Previous studies among healthy workers suggest that the psychosocial working environment is associated with sickness absence. Whether the psychosocial working environment plays a role for patients with existing cardiovascular disease on return to work and sickness absence is less studied. METHODS: A cohort of patients under 67 years and treated with percutaneous coronary intervention (PCI) was established in 2006. Three months after the procedure the patients (n = 625) answered a questionnaire about their psychosocial working environment. Patients were followed in registers for the following year. We examined the association between psychosocial working environment and sickness absence at 3 months, 1 year and new sick-listings during the first year with logistic regression. RESULTS: A total of 528 patients had returned to work 3 months after the PCI, while 97 was still sick-listed. After 1 year one was dead, 465 were working and 85 were receiving health related benefits, while 74 had left the workforce permanently. A number of 106 patients were sick-listed during the whole first year or had left the workforce permanently. After the initial return to work, 90 experienced a new sickness absence during the first year while the remaining 429 did not. High work pace, low commitment to the workplace, low recognition (rewards) and low job control were associated with sickness absence at 3 months, but not after 1 year. Low job control as well as job strain (combination of high demands and low control) was associated with new sick-listings. CONCLUSION: The psychosocial working environment was associated with sickness absence 3 months after the PCI, but not 1 year after.

Psychosocial Working Environment and Risk of Adverse Cardiac Events in Patients Treated for Coronary Heart Disease.

INTRODUCTION: During the last decades a possible association between psychosocial working environment and increased risk of coronary heart disease (CHD) has been debated and moderate evidence supports that high psychological demands, lack of social support and iso-strain (the combination of high job strain and lack of social support) is associated with primary CHD. Whether psychosocial working environment plays a role as risk factor for new cardiac events and readmissions in patients with existing cardiovascular disease is less studied. METHODS: A cohort of patients <67 years treated with percutaneous coronary intervention (PCI) was established in 2006. Three months after PCI patients answered a questionnaire about their psychosocial working environment. Patients were followed in the Danish National Patient Registry and the Danish Civil Registration System for 3+ years to identify adverse cardiac events and death. We analysed the association between psychosocial working environment and adverse cardiac events by Cox Regression. RESULTS: A number of 528 patients had returned to work 12 weeks after PCI, while 97 were still sick-listed. We identified 12 deaths and 211 other events during follow-up. We found no statistically significant associations between psychosocial working environment and risk of adverse cardiac events and readmissions or mortality. CONCLUSION: The psychosocial working environment was not associated with adverse cardiac events.

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.