Electronic Patient-reported Outcome Measures Research Articles

Development and validation of a novel personalized electronic patient-reported outcome measure to assess quality of life (Q-LIFE): a prospective observational study in people with Cystic Fibrosis

Generic and disease-specific patient-reported outcome measures (PROMs) may lack relevance and sensitivity on a patient-level in chronic diseases with differential disease expression and high individual variability, such as Cystic Fibrosis (CF). This study aimed to develop and validate a novel personalized electronic PROM (ePROM) that captures relevant aspects of quality of life in individuals with CF. The Q-Life app was developed as a short personalized ePROM to assess individual quality of life. Psychometric properties were assessed in a single-center cross-sectional study between September 2019 and September 2021 and in a prospective cohort study between September 2021 and September2022. Combined studies included 223 participants (median age: 24 years, IQR: 19.0-32.5 years, range: 12.0-58.0 years). Internal consistency (Cronbach's alpha: 0.83-0.90) and test-retest reliability (intraclass correlation coefficient: 0.90; 95% CI: 0.65-0.92; p<0.001) of quality of life (Q-Life) scores were strong. Q-Life scores were associated with overall Cystic Fibrosis Questionnaire-Revised (CFQ-R) scores (ρ=0.71; p<0.001), CFQ-R respiratory domain scores (ρ=0.57; p<0.001) and forced expiratory volume in 1s (ρ=0.41; p<0.001). Furthermore, Q-Life scores improved from 65.0 (IQR: 45.0-63.3) at baseline to 84.2 (IQR: 75.0-95.0) and 87.5 (IQR: 75.0-100.0) after 3 and 6 months of elexacaftor/tezacaftor/ivacaftor treatment (change: 20.8; 95% CI: 17.5-25.0; p<0.001), comparable to CFQ-R respiratory domain scores (change: 22.2, 95% CI: 19.4-25.0, p<0.001). The Q-Life app is a reliable, valid and sensitive personalized ePROM to measure all aspects of quality of life that really matter to individuals with Cystic Fibrosis. This patient-centered approach could provide important advantages over generic and disease-specific PROMs in the era of personalized medicine and value-based healthcare. Dutch Cystic Fibrosis Foundation, Health-Holland.

Evaluating the Usability and Equivalence of Electronic Patient-Reported Outcome Measures for Individuals with a Lower-Limb Amputation.

ABSTRACT Introduction Electronic versions of patient-reported outcome measures (PROMs) seem to have a clear administrative logging advantage to traditional paper versions. However, most of them have not been formally evaluated for their suitability to replace paper outcome measures for assessment of individuals with lower-limb amputations. The aim of this study is to examine the usability and equivalence of electronic to paper versions of PROMs suitable for use in prosthetic clinical care and research for persons with lower-limb loss. Methods In this cross-sectional study, 10 participants remotely completed the following PROMs online and then on paper: Orthotic and Prosthetic User Survey (OPUS), Modified Falls Efficacy Scale (MFES), Prosthetic Evaluation Questionnaire (PEQ), Patient Health Questionnaire–9 (PHQ-9), and Community Participation Indicators (CPI). Participants also answered open-ended and standardized questions regarding the usability of the electronic surveys. Wilcoxon signed rank tests, comparisons to minimum detectable change, intraclass correlation coefficients, and Bland-Altman plots were used to evaluate differences between the two survey versions, meaningful changes in scores, reliability, and systematic biases, respectively. Results Electronic surveys had fewer missing or ambiguous responses than paper surveys; however, the PEQ Social Burdens subscale could not be evaluated due to error in the creation of the electronic survey. No significant differences were found between scores of the two versions for any of the measures, but multiple participants had meaningful changes in the Appearance and Sounds PEQ subscales. All measures demonstrated acceptable reliability between versions, except the Appearance, Perceived Response, and Sounds subscales of the PEQ. No systematic biases in scores or usability concerns were found for any measures. Conclusions This study analysis showed that most of the electronic PROMs studied are easily used and demonstrate equivalence to the paper versions. However, the PEQ Appearance, Perceived Response, Sounds, and Social Burden subscales require further evaluation. Clinical Relevance Except for the PEQ, electronic versions of the PROMs in this study can likely be used interchangeably with paper versions among individuals with lower-limb loss.

Disconnected: Electronic Patient-Reported Outcome Measure Collection In Orthopaedic Patients at an Urban Safety-Net Hospital.

Collection of patient-reported outcome measures (PROMs) in orthopaedic patients at safety-net hospitals is challenging. The purpose of this study was to evaluate the success of electronic PROM (E-PROM) collection in this setting. A retrospective review identified 207 consecutive orthopaedic patients undergoing 77 elective arthroplasty procedures and 130 trauma procedures. E-PROMs were collected through automated e-mails from an online patient engagement platform (PatientIQ) at 2 weeks, 6 weeks, and 3 months postoperatively. Patients with trauma received the percentage of normal Single Assessment Numerical Evaluation (SANE) and Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF). Arthroplasty patients received the Hip/Knee SANE, Hip/Knee Disability and Osteoarthritis Outcome Score-Joint Replacement (HOOS Jr/KOOS Jr), PROMIS Global Physical Health (PROMIS-G-PH), and Veterans RAND 12-Item (VR-12) Health Survey. Compared with patients with trauma, arthroplasty patients were older (median difference 18.0 years; 95% confidence interval [CI] 12.0-22.0; P < 0.0001), more likely to be Hispanic/Black (proportional difference 16.9%; CI 2.8-30.3%; P = 0.02), more likely to have noncommercial or no insurance (proportional difference 34.0%; CI 23.2-43.0%; P < 0.001), and did not differ in Area Deprivation Index or E-PROM completion at each time point. E-PROMs were completed at 2 weeks, 6 weeks, and 3 months by 25.1% (52 of 207), 24.6% (51 of 207), and 21.7% (45 of 207) of all patients, respectively. Trauma and arthroplasty patients had a similar rate of partial E-PROM completion. Patients who completed 3-month E-PROMs were less likely to be Hispanic/Black (PD -16.4%; CI -31.0 to -0.2%; P < 0.04); less likely to have noncommercial/no insurance (PD -20.0%; CI -35.5 to -4.5%; P = 0.01); and did not differ in age, sex, Area Deprivation Index, or procedure type. The low collection rate of E-PROMs from orthopaedic patients at safety-net hospitals should be weighed against their costs. E-PROM collection may exacerbate disparities in PROM collection among certain patient populations. Diagnostic Level III.

Electronic Patient-Reported Outcome Measures (ePROMs) Improve the Assessment of Underrated Physical and Psychological Symptom Burden among Oncological Inpatients.

For advanced cancer inpatients, the established standard for gathering information about symptom burden involves a daily assessment by nursing staff using validated assessments. In contrast, a systematic assessment of patient-reported outcome measures (PROMs) is required, but it is not yet systematically implemented. We hypothesized that current practice results in underrating the severity of patients' symptom burden. To explore this hypothesis, we have established systematic electronic PROMs (ePROMs) using validated instruments at a major German Comprehensive Cancer Center. In this retrospective, non-interventional study, lasting from September 2021 to February 2022, we analyzed collected data from 230 inpatients. Symptom burden obtained by nursing staff was compared to the data acquired by ePROMs. Differences were detected by performing descriptive analyses, Chi-Square tests, Fisher's exact, Phi-correlation, Wilcoxon tests, and Cohen's r. Our analyses pointed out that pain and anxiety especially were significantly underrated by nursing staff. Nursing staff ranked these symptoms as non-existent, whereas patients stated at least mild symptom burden (pain: meanNRS/epaAC = 0 (no); meanePROM = 1 (mild); p < 0.05; r = 0.46; anxiety: meanepaAC = 0 (no); meanePROM = 1 (mild); p < 0.05; r = 0.48). In conclusion, supplementing routine symptom assessment used daily by nursing staff with the systematic, e-health-enabled acquisition of PROMs may improve the quality of supportive and palliative care.

P152 Development and validation of a personalised electronic patient-reported outcome measure to assess individual quality of life

To develop and validate a personalized patient-reported outcome measure (PROM) that enables a systematic assessment of the impact of care and treatment modalities on individual quality of life.

Exploring the Potential of Electronic Patient-Reported Outcome Measures to Inform and Assess Care in Sarcoma Centers: A Longitudinal Multicenter Pilot Study.

Electronic patient-reported outcome measures (ePROMs) are useful tools to assess care needs of patients diagnosed with cancer and to monitor their symptoms along the illness trajectory. Studies regarding the application of ePROMs by advanced practice nurses (APNs) specialized in sarcoma care and the use of such electronic measures for care planning and assessing quality of care are lacking. To explore the potential of ePROMs in clinical practice for assessing the patient's quality of life, physical functionality, needs, and fear of progression, as well as distress and the quality of care in sarcoma centers. A multicenter longitudinal pilot study design was chosen. Three sarcoma centers with and without APN service located in Switzerland were included. The instruments EQ-5D-5L, Pearman Mayo Survey of Needs, the National Comprehensive Cancer Network Distress Thermometer, PA-F12, and Toronto Extremity Salvage Score were used as ePROMs. Data were analyzed descriptively. Overall, 55 patients participated in the pilot study; 33 (60%) received an intervention by an APN, and 22 (40%) did not. Patients in sarcoma centers with APN service reported overall higher scores in quality of life and functional outcome. The number of needs and distress level were lower in sarcoma centers with APN service. No differences were found with respect to patients' fear of progression. Most of the ePROMs proved to be reasonable in clinical practice. PA-F12 has shown low clinical relevance. Using ePROMs appears to be reasonable to obtain clinically relevant patient information and to evaluate the quality of care in sarcoma centers.

Feasibility of Weekly Electronic Patient- and Proxy-Reported Outcome Measures in Pediatric Oncology.

Electronic patient-reported outcome measures (ePROMs) benefit adult cancer care, but their use in pediatric cancer care is limited. To explore the feasibility of collecting weekly ePROMs from pediatric cancer patients and/or their caregivers and to describe children's levels of symptom burden, distress, and cancer-related quality of life. A prospective and longitudinal cohort study was undertaken at one tertiary children's cancer center. Children (2-18 years)/caregivers completed ePROMs with validated measures for distress, symptom burden, and cancer-related quality of life weekly for 8 weeks. Seventy children/caregivers participated in the study, and 69% completed ePROMs at all 8 weeks. Distress and cancer-related quality of life significantly improved over time. However, at week 8, almost half of the participants still reported high levels of distress. Symptom burden decreased over time, with the youngest and the oldest age groups (2-3 and 13-18 years) reporting the highest number of symptoms with severe burden. Weekly collection of ePROMs in pediatric cancer care is feasible. Although distress, quality of life, and symptom burden improve over time, there is a need for timely assessment and interventions to improve symptoms, high levels of distress, and issues that negatively affect quality of life. Nurses are ideally placed to intervene, assess, and monitor symptoms and to provide symptom management advice to pediatric cancer patients and caregivers. Findings from this study may inform the design of models of pediatric cancer care to improve communication with the healthcare team and patient experience of care.

Dissemination and Early Experiences of an Electronic Patient-Reported Outcome Measure in Nephrology Clinic.

Patel, Dipal M.1,a; Thavarajah, Sumeska1; Bitzel, Jack1; Grader-Beck, Thomas2; Fine, Derek M.1; Grams, Morgan E.3; Parikh, Chirag R.1; Crews, Deidra C.1,4 Author Information

Patient and clinician-reported experiences of using electronic patient reported outcome measures (ePROMs) as part of routine cancer care

BackgroundCancer and its treatment can have significant impacts on health status, quality of life and functioning of patients. Direct information from patients regarding these aspects can be collected via electronic platforms in the form of electronic Patient Reported Outcome Measures (ePROMs). Research has shown that the use of ePROMS in cancer care leads to improved communication, better symptom control, prolonged survival and a reduction in hospital admissions and emergency department attendance. Acceptability and feasibility of routine ePROM collection has been reported by both patients and clinicians but to date their use has predominantly been limited to clinical trials. MyChristie-MyHealth is an initiative from a UK comprehensive cancer centre The Christie NHS Foundation Trust which incorporates the regular collection of ePROMs into routine cancer care. This study, carried out as part of a service evaluation, explores patient and clinician experiences of using the MyChristie-MyHealth ePROMs service.Results100 patients with lung and head and neck cancers completed a Patient Reported Experience questionnaire. All patients reported that MyChristie-MyHealth was easy to understand and, almost all found it timely to complete and easy to follow. Most patients (82%) reported it improved their communication with their oncology team and helped them to feel more involved with their care (88%). A large proportion of clinicians (8/11) felt ePROMs helped communication with their patients and over half (6/10) felt they led to consultations being more patient focused. Clinicians also felt that the use of ePROMs resulted in patients being more engaged in consultations (7/11) and their cancer care in general (5/11). Five clinicians reported that the use of ePROMs altered their clinical decision making.ConclusionsRegular ePROMs collection as part of routine cancer care is acceptable to both patients and clinicians. Both patients and clinicians feel their use improved communication and increased the feeling of patient involvement with their care. Further work is needed to explore the experiences of patients that did not complete the ePROMs as part of the initiative and to continue to optimize the service for both patients and clinicians.

Improving the Understanding and Managing of the Quality of Life of Patients With Lung Cancer With Electronic Patient-Reported Outcome Measures: Scoping Review.

Electronic patient-reported outcome measures (ePROMs) are essential to clinical practice and research. The growth of eHealth technologies has provided unprecedented opportunities to collect information systematically through ePROMs. Although they are widely used in scientific research, more evidence is needed to determine their use and implementation in daily clinical practice. For example, when diagnosed, patients with lung cancer are at an advanced stage of the disease. This entails tremendous burden because of high mortality and losses in the different dimensions of the human being. In this case, monitoring symptoms and other outcomes help improve the patient's quality of life. ePROMs offered unprecedented opportunities to collect information systematically. Our goal was to demonstrate that ePROMs are more useful in controlling patient symptoms, lung cancer, and overall survival than their alternatives, such as nonelectronic PROMs. This exploratory review considered articles published between 2017 and 2022 identified through searches of PubMed, Scopus, Cochrane, CINAHL, and PsycINFO. We found 5097 articles; after removing the duplicates, we reduced them to 3315. After reading the summary, we were left with 56. Finally, after applying the exclusion criteria, we reviewed 12. The 5-step framework by Arksey and O'Malley was used to refine the initial search results with the following research questions: Do ePROMs help physician-patient communication? To what extent do they improve decision-making? Are institutions and their digitization policies barriers to or facilitators of this process? and What else is needed for routine implementation? This review included 12 articles. We found that ePROMs are an integrative and facilitative communication tool, highlighting their importance in the relationship between palliative care and medical oncology. ePROMs help assess patient symptoms and functionality more accurately and facilitate clinical decision-making. In addition, it allows for more precise predictions of overall patient survival and the adverse effects of their treatments. The main institutional obstacles are the initial investment, which can be costly, and the data protection policy. However, enablers included better funding through the development of telemedicine, support from institutional leaders to overcome resistance to change, and transparent policies to ensure the safe and secure use of ePROMs. Routine collection of remote ePROMs is an effective and valuable strategy for providing real-time clinical feedback. In addition, it provides satisfaction to patients and professionals. Optimizing ePROMs in patients with lung cancer leads to a more accurate view of health outcomes and ensures quality patient follow-up. It also allows us to stratify patients based on their morbidity, creating specific follow-ups for their needs. However, data privacy and security are concerns when using ePROMs to ensure compliance with local entities. At least four barriers were identified: cost, complex programming within health systems, safety, and social and health literacy.

Automating Patient-Reported Outcome Measures Following Hand Surgery

The purpose of this study was to assess the overall response rate of patients receiving electronic patient-reported outcome measures (ePROMs) following hand surgery and to determine the patient characteristics associated with responding. A Health Insurance Portability and Accountability Act-compliant, web-based system was developed to automatically distribute ePROMs to patients undergoing hand surgery at five institutions with 22 surgeons. Patients who were at least 18 years old were eligible. The PROMs used were the visual analog scale (VAS) for pain and the Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH). After surgery, ePROMs along with a satisfaction questionnaire were electronically sent three, six, 12, 24, and 52 weeks after surgery. A total of 6458 patients were eligible. Of these, 80% were enrolled voluntarily. Among these, 70% completed ePROMs for at least one postoperative time point, whereas 30% did not complete any. Among responders, 28% completed all five time points, whereas 72% completed four or fewer time points. Incomplete responders were more likely to be insured by workers' compensation when compared to complete responders. Incomplete responders exhibited higher baseline QuickDASH scores and similar baseline VAS compared to complete responders. During the follow-up, incomplete responders demonstrated worse VAS and QuickDASH scores at all time points. Finally, in comparison with complete responders, incomplete responders were less likely to be satisfied with their surgery at all time points. This study demonstrates that automated email-based ePROM systems may be an effective method for survey distribution. Particularly for simple, outpatient surgeries, this study illustrates the potential for clinical use of the data obtained from these systems. Patient-reported outcome measures continue to have an expanding role in health care with the rise of valued-based systems. Electronic PROMs are a relatively unexplored medium that may offer a viable alternative to more effectively collecting these valuable patient metrics.

P040 The clinical impact of electronic patient-reported outcome measures in remotely monitoring inflammatory arthritis: a systematic review

Abstract Background/Aims The inflammatory arthritides make up a majority of conditions requiring follow-up in rheumatology clinics; a treat-to-target management approach is advocated in patients with inflammatory arthritis (IA), requiring regular monitoring. With rising patient numbers and increasing demand on clinics, integration of digital healthcare has been advocated as a means to improving this, potentially allowing for fewer outpatient visits. The objective of this review is to evaluate the clinical effectiveness of electronic patient-reported outcome measures (ePROMs) as a digital remote monitoring intervention on disease activity and treatment decisions in patients with inflammatory arthritis. Methods Five databases including MEDLINE, Embase, PubMed, Cochrane Library and Web of Science were searched from inception to 29 August 2022. Randomised controlled trials (RCT) and (non-randomised) controlled clinical trials considering remote monitoring with ePROMS in IA samples that assessed disease activity scores, disease flare, treatment escalation and healthcare use were included, with meta-analysis and forest plots conducted for each outcome. Data regarding between-group differences in outcomes were extracted and a risk of bias assessment was completed by two assessors on all included studies using Cochrane Risk of Bias (RoB)-2 tool for RCTs and Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) for non-randomised cohorts. Results The literature search identified 4230 abstracts, of which 8 relevant studies were included in the analysis after de-duplication and screening. Seven studies assessed patients with rheumatoid arthritis and one involved patients with axial spondyloarthritis. Most included studies were at high risk of bias. Compared with control, the disease activity in the ePROM group was lower (standardised mean difference (SMD) -0.15; 95% CI -0.27 to -0.03). A second analysis using a stricter definition of ePROM use limiting to studies without other combined interventions (eg. disease education) showed the same direction of effect but was not significant (SMD -0.13; 95% CI -0.31 to 0.04). There were no significant differences between groups in terms of disease flare (OR 2.32; 95% CI 0.21 to 25.28), escalation of immunosuppression (OR 1.12; 95% CI 0.70 to 1.80) or face-to-face clinic visits (OR -0.93; 95% CI -2.14 to 0.28). Conclusion This review suggests there is an advantage in using ePROMs to remotely monitor patients with IA in terms of disease outcomes. Importantly there was no detrimental impact in terms of clinic attendance frequency with ePROMs. There are limitations including heterogeneity in study design and substantial risk of bias in the studies included. ePROMs are likely here to stay, but we need better quality data to fully understand their role in clinical practice. Disclosure N. Arumalla: None. M. Adas: None. C.K.D. Chan: None. M. Gibson: None. Y.L. Man: None. S. Norton: None. J. Galloway: Honoraria; from AbbVie, Celgene, Chugai, Galapagos, Gilead, Janssen, Lilly, Pfizer, Roche and UCB. T. Garrood: None.

Patient-reported outcomes and patient-reported outcome measures in liver transplantation: a scoping review.

Generic or condition-specific Patient-reported Outcome Measures (PROMs) are used to measure physical, mental, and social aspects of health to promote patient-centered care. This scoping review aims to identify and summarize generic and condition-specific PRO domains and PROMs that have been assessed and used in liver transplant (LT) candidates and recipients. We searched Medline, Embase, Cochrane Database of Systematic Reviews and Register of Trials, PsychInfo, and CINAHL from inception to 08/26/2020. Included studies addressed a PRO or PROM in LT candidates or recipients. After screening, 341 studies yielded 189 unique PRO domains. Mental health domains (depression, anxiety, and guilt) were most frequently assessed, followed by domains of physical and social health. Fifty-one generic and three condition-specific unique PROMs were identified, with only 13% (n = 45) of studies including condition-specific tools. The most frequent PROMs were the SF-36, Nottingham Health Profile, Hospital Anxiety and Depression Scale, followed by the Liver Disease Quality of Life (LDQoL). Very few studies used transplant-specific PROMs, which may partly be related to the scarcity of LT-specific instruments. We will use these results in future qualitative research to identify PROs and PROMs to build an electronic PROM toolkit to facilitate patient-centered LT care.

Experience With the Routine Use of Electronic Patient-Reported Outcome Measures for Patients With Lung Cancer.

The Christie NHS Foundation Trust launched their electronic patient-reported outcome measures (ePROMs) service in January 2019 in the routine clinical setting. The lung cancer questionnaires consist of 14 symptom items, adapted from the Common Terminology Criteria for Adverse Events (version 5.0) and the EuroQol EQ-5D-5L quality-of-life (QoL) tool. Patients with lung cancer are invited to complete questionnaires assessing their symptoms and QoL using an online platform. The ePROM responses and clinical, pathologic, and treatment data for patients who completed the questionnaires between January 2019 and December 2020 were extracted from electronic medical records. The symptom and QoL scores of patients who completed baseline pretreatment ePROMs and also those who completed ePROMs pre- and postpalliative lung systemic anticancer therapy (SACT) or radical thoracic radiotherapy were evaluated. Pretreatment questionnaires were analyzed according to age, Eastern Cooperative Oncology Group performance status (ECOG PS), and Adult Comorbidity Evaluation-27 (ACE-27) comorbidity score. One thousand four hundred eighty patients with lung cancer were included. There were no statistically significant differences in symptoms and QoL scores between age groups. Cough (P = .006) and EQ-5D-5L mobility scores (P = .006) were significantly worse for patients with an ECOG PS of 0-1. Dyspnea (P = .035), hemoptysis (P = .023), nausea (P = .041), mobility (P = .004), and self-care (P = .0420) were significantly worse for those with higher ACE-27 scores (2-3 v 0-1). Palliative SACT was associated with a significant improvement in cough (P < .001) and hemoptysis (P = .025), but significantly negatively affected mobility (P = .013). Patients receiving radical thoracic radiotherapy reported a significant improvement in hemoptysis (P = .042) but worse pain (P = .002) and fatigue (P = .01). Other changes in symptom and QoL scores were not significant. The symptoms and QoL reported at baseline and before and after both palliative SACT and radical thoracic radiotherapy are clinically relevant and meaningful. We have demonstrated that routine implementation of ePROMs into clinical practice is feasible and can inform clinical practice and future research.

10 - The routine clinical use of electronic patient-reported outcome measures (ePROMs) for patients with lung cancer

10 - The routine clinical use of electronic patient-reported outcome measures (ePROMs) for patients with lung cancer

Real-time Symptom Assessment in Patients With Endometriosis: Psychometric Evaluation of an Electronic Patient-Reported Outcome Measure, Based on the Experience Sampling Method.

The experience sampling method (ESM) holds advantages over traditional retrospective questionnaires including a high ecological validity, no recall bias, the ability to assess fluctuation of symptoms, and the ability to analyze the temporal relationship between variables. This study aimed to evaluate the psychometric properties of an endometriosis-specific ESM tool. This is a short-term follow-up prospective study, including patients with premenopausal endometriosis aged ≥18 years who reported dysmenorrhea, chronic pelvic pain, or dyspareunia between December 2019 and November 2020. An ESM-based questionnaire was sent out by a smartphone application 10 times a day during 1 week on randomly chosen moments. Additionally, patients completed questionnaires concerning demographics, end-of-day pain scores, and end-of-week symptom scores. The psychometric evaluation included compliance, concurrent validity, and internal consistency. Twenty-eight patients with endometriosis completed the study. Compliance for answering the ESM questions was as high as 52%. End-of-week pain scores were higher than ESM mean scores and showed peak reporting. ESM scores showed strong concurrent validity when compared with symptoms scored by the Gastrointestinal Symptom Rating Scale-Irritable Bowel Syndrome, 7-item Generalized Anxiety Disorders Scale, 9-question Patient Health Questionnaire, and the majority of questions of the 30-item Endometriosis Health Profile. Cronbach α coefficients demonstrated a good internal consistency for abdominal symptoms, general somatic symptoms, and positive affect, and an excellent internal consistency for negative affect. This study supports the validity and reliability of a newly developed electronic instrument for the measurement of symptoms in women with endometriosis, based on momentary assessments. This ESM patient-reported outcome measure has the advantage of providing a more detailed view on individual symptom patterns and offers the possibility for patients to have insight in their symptomatology, leading to more individualized treatment strategies that can improve the quality of life of women with endometriosis.

Electronic versus paper patient-reported outcome measure compliance rates: A retrospective analysis

ObjectivePatient-reported outcome measures (PROMs) are key tools used to inform clinical research and patient-centered care. Application of data collected from PROMs, however, may be limited by incomplete responses, and little is known regarding the efficacy of varied PROM delivery methods. The objective of this study was to compare PROMs compliance when delivered via paper and electronic formats. MethodsElective adult spinal deformity patients were screened for inclusion. Data collected included demographics, type of surgery, PROMs compliance, and discharge care. Descriptive statistics and multivariate analysis (MVA) were performed to compare pre- and postoperative compliance rates. ResultsOf the 474 included patients, 177 were administered paper PROMs, while 297 were electronic. Preoperatively, 101 patients (57.1%) had any portion of their paper PROMs available; 179 (60.3%) had any of their electronic PROMs available (p = 0.492). Among all patients, 76 (42.9%) and 170 (57.2%) had all of their completed preop PROMs available (p = 0.003). Among patients with any of their preop PROMs completed, 75.2% with paper and 95.0% with electronic were completed in their entirety (p < 0.001). Similar trends were observed among postoperative PROMs. MVA demonstrated electronic delivery as the only significant correlate with pre- and post-operative PROMs compliance (p < 0.001 and p = 0.003, respectively). ConclusionsNo differences were observed across modalities when considering any available PROMs, yet electronic PROM delivery was associated with higher completion of PROMs. In order to improve the quality of patient-reported data, electronic delivery with alternative methods of quality improvement may be considered to increase PROMs retention rates.

Qualitative Interviews to Assess the Content Validity and Usability of the Electronic Raynaud Diary in Patients with Systemic Sclerosis.

To better understand the symptoms and impacts of Raynaud phenomenon (RP) in patients with systemic sclerosis (SSc) and to evaluate the content validity and usability of a new electronic patient-reported outcome (PRO) measure for RP: the Raynaud Diary. The Raynaud Diary was developed as a daily eDiary for assessing the number and duration of symptomatic Raynaud attacks; worst pain, numbness, tingling, and discomfort in the fingers; and overall disease severity, captured using the Raynaud's Condition Score. The Raynaud Diary was debriefed in two waves of qualitative interviews with adults with self-reported RP secondary to SSc. All interviews included open-ended questions about participants' experiences of RP. Participants (N=39) had a mean age of 55.1 years, and 87% were female. Frequently reported RP symptoms were color change (reported by all participants), numbness (90%), tingling (82%), pain (77%), and discomfort (72%). Common attack triggers included temperature-related factors and stress. Participants reported being unable to be outside or do outdoor activities and had problems gripping objects. All participants demonstrated understanding of the Raynaud Diary instructions. Most participants indicated that they would be able to use the Raynaud Diary to record the worst severity of individual RP symptoms in the previous 24 hours. Patients with RP secondary to SSc bear a heavy symptom burden. The Raynaud Diary is a content valid PRO measure that captures the most frequent symptoms of RP in patients with SSc.

A NEw MOdel of individualized and patient-centered follow-up for women with gynecological cancer (the NEMO study)—protocol and rationale of a randomized clinical trial

BackgroundFollow-up programs for gynecological cancer patients are currently under revision. There is limited evidence that traditional follow-up and clinical examinations improve survival in an early-stage gynecological setting. Further, traditional follow-up programs fail to accommodate the patient’s need for psychosocial and sexual supportive care and to actively involve patients and their relatives in the follow-up process. Individualized programs may replace traditional routine follow-up with fixed intervals and length. Focusing on alarm-symptoms and self-reporting may ensure detection of recurrence while allowing a continuous attention to the patient’s well-being and return to daily life.In this study, a nurse-led, individualized, and need-based intervention with a specific focus on patient empowerment is tested against a standard physician-led model primarily focusing on the detection of recurrence.MethodsThe study is designed as a clinical, randomized trial conducted in one of four national onco-gynecological centers in Denmark. Patients with early-stage cervical or endometrial cancer are eligible for inclusion. The intervention group undergoes individualized, nurse-led follow-up supporting patient empowerment including repeated use of electronic patient-reported outcome measures (ePROMs) before each contact as a dialogue support tool. The follow-up contacts are mainly conducted by telephone. All project nurses attended a special training program before project start and are all well-educated and dedicated onco-gynecological nurses. The control group receives standard, physician-led, follow-up without use of ePROMs or specific focus on empowerment.The effect of the intervention is evaluated by questionnaires completed by patients at baseline (3 months after surgery) and 12, 18, and 36 months after surgery. Outcomes include empowerment using the Skill and technique subscale of the HEI-Q questionnaire as the primary outcome while fear of cancer recurrence and health-related quality of life as well as the remaining subscales of the HEI-Q represent secondary outcomes. Data is collected by use of the REDCap technology, which also provides a customized visual support function for the dialogue tool.DiscussionThis study will provide new information about follow-up in early-stage gynecological cancer settings and thereby contribute to improvement of future follow-up programs. Importantly, the study will provide knowledge about the impact of specific focus on patient empowerment in follow-up programs and, further, how to facilitate empowerment among patients.Trial registrationThe study is registered at clinicaltrials.gov: ID no. NCT03838861. Registered on 6 February 2019.Protocol version 2, issue date 21 November 2022.

Challenges developing an electronic patient-reported outcome measurement for palliative home care: A qualitative interview and focus group study

Background: Patient-reported outcome measures have the potential to improve outcomes, quality, and effectiveness of care. Digital use of patient-reported outcome measures could be an option to foster implementation in palliative care. The Palli-MONITOR study focused on developing and testing an electronic patient-reported outcome measure in specialised palliative home care. As part of this study, we examined setting-specific challenges for the development of the measure. Aim: We aimed to identify and explore challenges for the development of electronic patient-reported outcome measures as standardised assessment in specialised palliative home care. Design: Qualitative approach with semi-structured interviews and focus groups. Data were thematically analysed using the framework method. Setting/Participants: Patients and professionals from five German palliative home care teams. Results: Patients described potential problems in using electronic questionnaires due to their deteriorating health. Answering the electronic questionnaire encouraged patients to reflect on their current palliative situation, which was partly perceived as burdensome. Identified concerns and questions regarding the future roll-out of electronic patient-reported outcome measurement addressed the process of receiving and using the provided information in clinical care routine. Challenging factors on organisational and structural level were the potential undermining of the established 24-h emergency call system and the potential use for patients. Conclusions: Our results provide a multifaceted picture of challenges developing electronic systems for patient-reported outcome measurement in palliative home care on the individual and organisational level. The study underpins the benefit of stakeholder involvement creating digital health innovations and emphasises the importance to therefore mind setting specific culture.