Remote Consultations Versus Standard Face-to-Face Appointments for Liver Transplant Patients in Routine Hospital Care: Feasibility Randomized Controlled Trial of myVideoClinic.

BACKGROUND: Using technology to reduce the pressure on the National Health Service (NHS) in England and Wales is a key government target, and the NHS Long-Term Plan outlines a strategy for digitally enabled outpatient care to become mainstream by 2024. In 2020, the COVID-19 response saw the widespread introduction of remote consultations for patient follow-up, regardless of individual preferences. Despite this rapid change, there may be enduring barriers to the effective implementation of remote appointments into routine practice once the unique drivers for change during the COVID-19 pandemic no longer apply, to which pre-COVID implementation studies can offer important insights. OBJECTIVE: This study aims to evaluate the feasibility of using real-time remote consultations between patients and secondary care physicians for routine patient follow-up at a large hospital in the United Kingdom and to assess whether patient satisfaction differs between intervention and usual care patients. METHODS: Clinically stable liver transplant patients were randomized to real-time remote consultations in which their hospital physician used secure videoconferencing software (intervention) or standard face-to-face appointments (usual care). Participants were asked to complete postappointment questionnaires over 12 months. Data were analyzed on an intention-to-treat basis. The primary outcome was the difference in scores between baseline and study end by patient group for the three domains of patient satisfaction (assessed using the Visit-Specific Satisfaction Instrument). An embedded qualitative process evaluation used interviews to assess patient and staff experiences. RESULTS: Of the 54 patients who were randomized, 29 (54%) received remote consultations, and 25 (46%) received usual care (recruitment rate: 54/203, 26.6%). The crossover between study arms was high (13/29, 45%). A total of 129 appointments were completed, with 63.6% (82/129) of the questionnaires being returned. Patient satisfaction at 12 months increased in both the intervention (25 points) and usual care (14 points) groups. The within-group analysis showed that the increases were significant for both intervention (P<.001) and usual care (P=.02) patients; however, the between-group difference was not significant after controlling for baseline scores (P=.10). The qualitative process evaluation showed that-according to patients-remote consultations saved time and money, were less burdensome, and caused fewer negative impacts on health. Technical problems with the software were common, and only 17% (5/29) of patients received all appointments over video. Both consultants and patients saw remote consultations as positive and beneficial. CONCLUSIONS: Using technology to conduct routine follow-up appointments remotely may ease some of the resource and infrastructure challenges faced by the UK NHS and free up clinic space for patients who must be seen face-to-face. Our findings regarding the advantages and challenges of using remote consultations for routine follow-ups of liver transplant patients have important implications for service organization and delivery in the postpandemic NHS. TRIAL REGISTRATION: ISRCTN Registry 14093266; https://www.isrctn.com/ISRCTN14093266. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-018-2953-4.

Developing a real-time electronic symptom monitoring system for patients after discharge following cancer-related surgery.

BACKGROUND: Patients undergoing major cancer surgery frequently require post-acute care for complications and adverse effects. Enhanced recovery after surgery programmes mean that patients are increasingly discharged home earlier. Symptom/complication detection post-discharge is sub-optimal. Systematic patient monitoring post-discharge following surgery may be optimally achieved through routine electronic patient-reported outcome (ePRO) data capture. ePRO systems that employ clinical algorithms to guide management of patients and automatically alert clinicians of clinically-concerning symptoms can improve patient outcomes and decrease hospital admissions. ePRO systems that provide individually-tailored self-management advice and integrate live ePRO data into electronic health records (EHR) may also advance personalised health and patient-centred care. This study aims to develop a hospital EHR-integrated ePRO system to improve detection and management of complications post-discharge following cancer-related surgery. METHODS: The ePRO system was developed in two phases: (1) Development of a web-based ePRO symptom-report from validated European Organisation for Research and Treatment of Cancer (EORTC) questionnaires, clinical opinion and patient interviews, followed by hospital EHR integration; (2) Development of clinical algorithms triggering symptom severity-dependent patient advice and clinician alerts from: (i) prospectively-collected patient-completed ePRO symptom-report data; (ii) stakeholder meetings; (iii) patient interviews. Patient advice was developed from: (i) clinician-patient telephone consultations and patient interviews; (ii) review of hospital patient information leaflets (PIL) and patient support websites. RESULTS: Phase 1, including interviews with 18 patients, identified 35 symptom-report items. In phase 2, 130/300 (43%) screened patients were eligible. 61 (47%) consented to participate and 59 (97%) provided 444 complete self-reports. Stakeholder meetings (9 clinicians, 1 patient/public representative) and patient interviews (n = 66) refined advice/alert accuracy. 15 telephone consultations, 7 patient interviews and review of 28 PILs and 3 patient support websites identified 4 themes to inform self-management advice. Comparisons between ePRO symptom-report data, telephone consultations and clinical events/outcomes (n = 27 patients) further refined clinical algorithms. CONCLUSIONS: A hospital EHR-integrated ePRO system that alerts clinicians and provides patient self-management advice has been developed to improve the detection and management of problems and complications after discharge following surgery. An ongoing pilot study will inform a multicentre randomised trial to evaluate the effectiveness of the ePRO system compared to usual care.

Electronic Patient Reporting of Adverse Events and Quality of Life: A Prospective Feasibility Study in General Oncology.

PURPOSE: Adverse event (AE) reporting is essential in clinical trials. Clinician interpretation can result in under-reporting; therefore, the value of patient self-reporting has been recognized. The National Cancer Institute has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for direct patient AE reporting. A nonrandomized prospective cohort feasibility study aimed to explore the compliance and acceptability of an electronic (Internet or telephone) system for collecting patient self-reported AEs and quality of life (QOL). METHODS: Oncology patients undergoing treatment (chemotherapy, targeted agents, hormone therapy, radiotherapy, and/or surgery) at 2 hospitals were sent automated weekly reminders to complete PRO-CTCAE once a week and QOL (for a maximum of 12 weeks). Patients had to speak/understand English and have access to the Internet or a touch-tone telephone. Primary outcome was compliance (proportion of expected questionnaires), and recruitment rate, attrition, and patient/staff feedback were also explored. RESULTS: Of 520 patients, 249 consented (47.9%)-mean age was 62 years, 51% were male, and 70% were married-and 230 remained on the study at week 12. PRO-CTCAE was completed at 2,301 (74.9%) of 3,074 timepoints and QOL at 749 (79.1%) of 947 timepoints. Individual weekly/once every 4 weeks compliance reduced over time but was more than 60% throughout. Of 230 patients, 106 (46.1%) completed 13 or more PRO-CTCAE, and 136 (59.1%) of 230 patients completed 4 QOL questionnaires. Most were completed on the Internet (82.3%; mean age, 60.8 years), which was quicker, but older patients preferred the telephone option (mean age, 70.0 years). Positive feedback was received from patients and staff. CONCLUSION: Self-reporting of AEs and QOL using an electronic home-based system is feasible and acceptable. Implementation of this approach in cancer clinical trials may improve the precision and accuracy of AE reporting.

Video clinics versus standard face-to-face appointments for liver transplant patients in routine hospital outpatient care: study protocol for a pragmatic randomised evaluation of myVideoClinic.

BACKGROUND: Video clinics, where patients can have a hospital appointment with their clinician from home, are emerging in practice, but their effectiveness is unclear. This study will evaluate whether a video clinic implemented at the University Hospitals Birmingham (UHB) NHS Foundation Trust improves patient satisfaction compared to standard face-to-face appointments for liver transplant patients. METHODS: This will be a parallel, two-arm, statistician-blinded, randomised evaluation. Clinically stable liver patients at 1 to 5 years post-transplant (n = 180) will be randomised in equal numbers to video clinic appointments (intervention) or standard face-to-face appointments (control). The intervention group will have outpatient appointments from home via a secure video link accessed through the UHB patient portal. All patients will complete baseline questionnaires before randomisation and electronic follow-up questionnaires after each follow-up appointment during the subsequent 12 months. The primary outcome is the difference in scores between groups for three domains of patient satisfaction, namely 'convenience of location', 'getting through to the office by phone' and 'length of time waiting' (modified Visit-Specific Satisfaction Instrument). Secondary outcomes include quality of life (EQ-5D-5 L), costs, clinical contacts and user experience. Statistical analysis will be descriptive and performed on an intention-to-treat basis. The primary outcome will be analysed using baseline and 3-, 6-, 9- and 12-month questionnaires (according to patient follow-up appointment frequency) and comparisons made between study arms. A within-trial cost consequences analysis will be undertaken on the economic data. Patients (n = 8), carers/family members (n = 6) and health professionals (n = 14) will be interviewed about the experience of video clinics and the interviews will be analysed using thematic analysis. DISCUSSION: This study will allow an in depth understanding of whether video clinics can improve patient satisfaction with their care. In addition, the intervention could save patients time and costs, removing the need to travel long distances for outpatient appointments. Video clinics may be applicable to a wide range of other clinical settings and health conditions. The study has been approved by the NHS Health Research Authority and a National Research Ethics Committee (Ref: 17/WM/0338) and research governance approval has been obtained from UHB (Ref: RRK6080). TRIAL REGISTRATION: ISRCTN: 14093266 (25/03/2018; retrospectively registered).

Informing efficient randomised controlled trials: exploration of challenges in developing progression criteria for internal pilot studies.

OBJECTIVES: Designing studies with an internal pilot phase may optimise the use of pilot work to inform more efficient randomised controlled trials (RCTs). Careful selection of preagreed decision or 'progression' criteria at the juncture between the internal pilot and main trial phases provides a valuable opportunity to evaluate the likely success of the main trial and optimise its design or, if necessary, to make the decision not to proceed with the main trial. Guidance on the appropriate selection and application of progression criteria is, however, lacking. This paper outlines the key issues to consider in the optimal development and review of operational progression criteria for RCTs with an internal pilot phase. DESIGN: A structured literature review and exploration of stakeholders' opinions at a Medical Research Council (MRC) Hubs for Trials Methodology Research workshop. Key stakeholders included triallists, methodologists, statisticians and funders. RESULTS: There is considerable variation in the use of progression criteria for RCTs with an internal pilot phase, although 3 common issues predominate: trial recruitment, protocol adherence and outcome data. Detailed and systematic reporting around the decision-making process for stopping, amending or proceeding to a main trial is uncommon, which may hamper understanding in the research community about the appropriate and optimal use of RCTs with an internal pilot phase. 10 top tips for the development, use and reporting of progression criteria for internal pilot studies are presented. CONCLUSIONS: Systematic and transparent reporting of the design, results and evaluation of internal pilot trials in the literature should be encouraged in order to facilitate understanding in the research community and to inform future trials.

Discharge interventions for older patients leaving hospital: protocol for a systematic meta-review.

BACKGROUND: There is an increased need for additional care and support services for the elderly population. It is important to identify what support older people need once they are discharged from hospital and to ensure continuity of care. There is a large evidence base focusing on enhanced discharge services and their impact on patients. The services show some potential benefits, but there are inconsistent findings across reviews. Furthermore, it is unclear what elements of enhanced discharge interventions could be most beneficial to older people. This meta-review aims to identify existing systematic reviews of discharge interventions for older people, identify potentially effective elements of enhanced discharge services for this patient group and identify areas where further work may still be needed. METHODS/DESIGN: The search will aim to identify English language systematic reviews that have assessed the effectiveness of discharge interventions for older people. The following databases will be searched: Medline, Embase, PsycINFO, HMIC, Social Policy and Practice, CINAHL, the Cochrane Library, ASSIA, Social Science Citation Index and the Grey Literature Report. The search strategy will comprise the keywords 'systematic reviews', 'older people' and 'discharge'. Discharge interventions must aim to support older patients before, during and/or after discharge from hospital. Outcomes of interest will include mortality, readmissions, length of hospital stay, patient health status, patient and carer satisfaction and staff views. Abstract, title and full text screening will be conducted independently by two reviewers. Data extracted from reviews will include review characteristics, patient population, review quality score, outcome measures and review findings, and a narrative synthesis will be conducted. DISCUSSION: This review will identify existing reviews of discharge interventions and appraise how these interventions can impact outcomes in older people such as readmissions, health status, length of hospital stay and mortality. The review could inform practice and will help identify where further research is needed. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42015025737.