IntroductionThe use of electronic patient-reported outcome (ePRO) systems to capture PRO data in clinical trials is increasing; however, their feasibility, acceptability and utility in clinical ...trials of advanced therapy medicinal products (ATMPs) are not yet well understood. This protocol describes a qualitative study that aims to evaluate the feasibility and acceptability of ePRO data capture using a trial-specific ePRO system (the PROmics system) within an advanced therapy trial involving patients with immune-mediated inflammatory disease (rheumatoid arthritis, lupus, primary sclerosing cholangitis (PSC) and Crohn’s disease).Methods and analysisThis protocol for a remote, qualitative, interview-based feasibility study is embedded within the POLARISE trial, a single-arm, phase II, multisite ATMP basket trial in the UK. 10–15 patients enrolled in the POLARISE trial and 10–15 research team members at the trial sites will be recruited. Participants will take part in semistructured interviews which will be transcribed verbatim and analysed thematically according to the framework method. Data collection and analysis will occur concurrently and iteratively. Researcher triangulation will be used to achieve a consensus-based analysis, enhancing rigour and trustworthiness.Ethics and disseminationThis study was approved by the London—West London and GTAC Research Ethics Committee (Ref: 21/LO/0475). Informed consent will be obtained from all participants prior to data collection. The study findings will be published in peer-review journals and disseminated via conference presentations and other media. Our patient and public involvement and engagement group and ATMP stakeholder networks will be consulted to maximise dissemination and impact.Trial registration numberISRCTN80103507.
Background
Electronic patient-reported outcome (ePRO) systems are increasingly used in clinical trials to provide evidence of efficacy and tolerability of treatment from the patient perspective. The ...aim of this study is twofold: (1) to describe how we developed an electronic platform for patients to report their symptoms, and (2) to develop and undertake usability testing of an ePRO solution for use in a study of cell therapy seeking to provide early evidence of efficacy and tolerability of treatment and test the feasibility of the system for use in later phase studies.
Methods
An ePRO system was designed to be used in a single arm, multi-centre, phase II basket trial investigating the safety and activity of the use of ORBCEL-C™ in the treatment of patients with inflammatory conditions. ORBCEL-C™ is an enriched Mesenchymal Stromal Cells product isolated from human umbilical cord tissue using CD362+ cell selection. Usability testing sessions were conducted using cognitive interviews and the ‘Think Aloud’ method with patient advisory group members and Research Nurses to assess the usability of the system.
Results
Nine patient partners and seven research nurses took part in one usability testing session. Measures of fatigue and health-related quality of life, the PRO-CTCAE™ and FACT-GP5 global tolerability question were included in the ePRO system. Alert notifications to the clinical team were triggered by PRO-CTCAE™ and FACT-GP5 scores. Patient participants liked the simplicity and responsiveness of the patient-facing app. Two patients were unable to complete the testing session, due to technical issues. Research Nurses suggested minor modifications to improve functionality and the layout of the clinician dashboard and the training materials.
Conclusion
By testing the effectiveness, efficiency, and satisfaction of our novel ePRO system (PROmics
R
), we learnt that most people with an inflammatory condition found it easy to report their symptoms using an app on their own device. Their experiences using the PROmics
R
ePRO system within a trial environment will be further explored in our upcoming feasibility testing. Research nurses were also positive and found the clinical dashboard easy-to-use. Using ePROs in early phase trials is important in order to provide evidence of therapeutic responses and tolerability, increase the evidence based, and inform methodology development.
Trial registration
: ISRCTN, ISRCTN80103507. Registered 01 April 2022,
https://www.isrctn.com/ISRCTN80103507
Plain English summary
More and more patients tell clinicians how they feel by completing questionnaires electronically. Therefore, it is important to assess how easy it is for patients to do this. In this study, we describe how we developed an electronic platform for patients to report their symptoms and how we tested the usability of this platform with patient partners and research nurses. Once the electronic platform was developed, quality of life and symptoms questionnaires were programmed onto it. Alerts were sent to the clinical team if specific scores were obtained on the symptoms questionnaires. Although two patient partners were not able to finish the testing session because of technical issues, the ones who completed the session liked its simplicity and responsiveness. The research nurses also liked the system and only suggested minor modifications. Following this testing, we refined the electronic platform to test it further in a larger study which investigates the safety and use of a drug. We hope that thanks to this electronic platform, we will obtain useful information on the safety and efficacy of treatment.
Dynamic movements of the hand, fingers, and thumb are difficult to measure due to the versatility and complexity of movement inherent in function. An innovative approach to measuring hand kinematics ...is proposed and validated. The proposed system utilizes the Microsoft Kinect and goes beyond gesture recognition to develop a validated measurement technique of finger kinematics. The proposed system adopted landmark definition (validated through ground truth estimation against assessors) and grip classification algorithms, including kinematic definitions (validated against a laboratory-based motion capture system). The results of the validation show 78% accuracy when identifying specific markerless landmarks. In addition, comparative data with a previously validated kinematic measurement technique show accuracy of MCP ± 10° (average absolute error (AAE) = 2.4°), PIP ± 12° (AAE = 4.8°), and DIP ± 11° (AAE = 4.8°). These results are notably better than clinically based alternative manual measurement techniques. The ability to measure hand movements, and therefore functional dexterity, without interfering with underlying composite movements, is the paramount objective to any bespoke measurement system. The proposed system is the first validated markerless measurement system using the Microsoft Kinect that is capable of measuring finger joint kinematics. It is suitable for home-based motion capture for the hand and, therefore, achieves this objective.
Work stress and resiliency in nurse leaders Rosa-Besa, Rocel dela; Graboso, Rebecca; Banal, Maria Soledad ...
Nursing management,
07/2021, Letnik:
52, Številka:
7
Journal Article
Recenzirano
Understanding work stress is essential to identify ways of addressing and effectively coping with it. This study looked at types of work stress and resiliency and if a difference exists in leaders' ...work stress and resiliency before and after an education program.
Predictive analytics monitoring, the use of patient data to provide continuous risk estimation of deterioration, is a promising new application of big data analytical techniques to the care of ...individual patients. We tested the hypothesis that continuous display of novel electronic risk visualization of respiratory and cardiovascular events would impact intensive care unit (ICU) patient outcomes. In an adult tertiary care surgical trauma ICU, we displayed risk estimation visualizations on a large monitor, but in the medical ICU in the same institution we did not. The risk estimates were based solely on analysis of continuous cardiorespiratory monitoring. We examined 4275 individual patient records within a 7 month time period preceding and following data display. We determined cases of septic shock, emergency intubation, hemorrhage, and death to compare rates per patient care pre-and post-implementation. Following implementation, the incidence of septic shock fell by half (
p
< 0.01 in a multivariate model that included age and APACHE) in the surgical trauma ICU, where the data were continuously on display, but by only 10% (
p
= NS) in the control Medical ICU. There were no significant changes in the other outcomes. Display of a predictive analytics monitor based on continuous cardiorespiratory monitoring was followed by a reduction in the rate of septic shock, even when controlling for age and APACHE score.
Current approaches to early detection of clinical deterioration in children have relied on intermittent track-and-trigger warning scores such as the Pediatric Early Warning Score (PEWS) that rely on ...periodic assessment and vital sign entry. There are limited data on the utility of these scores prior to events of decompensation leading to pediatric intensive care unit (PICU) transfer.
The purpose of our study was to determine the accuracy of recorded PEWS scores, assess clinical reasons for transfer, and describe the monitoring practices prior to PICU transfer involving acute decompensation.
We conducted a retrospective cohort study of patients ≤21 years of age transferred emergently from the acute care pediatric floor to the PICU due to clinical deterioration over an 8-year period. Clinical charts were abstracted to (1) determine the clinical reason for transfer, (2) quantify the frequency of physiological monitoring prior to transfer, and (3) assess the timing and accuracy of the PEWS scores 24 hours prior to transfer.
During the 8-year period, 72 children and adolescents had an emergent PICU transfer due to clinical deterioration, most often due to acute respiratory distress. Only 35% (25/72) of the sample was on continuous telemetry or pulse oximetry monitoring prior to the transfer event, and 47% (34/72) had at least one incorrectly documented PEWS score in the 24 hours prior to the event, with a score underreporting the actual severity of illness.
This analysis provides support for the routine assessment of clinical deterioration and advocates for more research focused on the use and utility of continuous cardiorespiratory monitoring for patients at risk for emergent transfer.
Abstract
Background
The purpose of this article is to describe neonatal intensive care unit clinician perceptions of a continuous predictive analytics technology and how those perceptions influenced ...clinician adoption. Adopting and integrating new technology into care is notoriously slow and difficult; realizing expected gains remain a challenge.
Methods
Semistructured interviews from a cross-section of neonatal physicians (
n
= 14) and nurses (
n
= 8) from a single U.S. medical center were collected 18 months following the conclusion of the predictive monitoring technology randomized control trial. Following qualitative descriptive analysis, innovation attributes from Diffusion of Innovation Theory-guided thematic development.
Results
Results suggest that the combination of physical location as well as lack of integration into work flow or methods of using data in care decisionmaking may have delayed clinicians from routinely paying attention to the data. Once data were routinely collected, documented, and reported during patient rounds and patient handoffs, clinicians came to view data as another vital sign. Through clinicians' observation of senior physicians and nurses, and ongoing dialogue about data trends and patient status, clinicians learned how to integrate these data in care decision making (e.g., differential diagnosis) and came to value the technology as beneficial to care delivery.
Discussion
The use of newly created predictive technologies that provide early warning of illness may require implementation strategies that acknowledge the risk–benefit of treatment clinicians must balance and take advantage of existing clinician training methods.
Exploring emotions is a defining feature of psychotherapy. This study explores how therapists orient to emotions when they cannot see or hear their clients. In analyzing 1,279 sessions of online ...text-based Cognitive Behavioral Therapy (CBT), we focused on therapists' commiserations (e.g., "I'm sorry to hear that") and their affective inferences (e.g., "that sounds very scary for you"). Both practices routinely prefaced moves to pursue a range of therapeutic activities, many of which did not prioritize sustained focus on the emotion that had just been oriented to. By separating message composition from message transmission, the modality used for these therapy sessions enabled therapists to combine orientations to emotion with attempts to shift the focus of discussion. Our analysis finds that although physically co-present and computer-mediated psychotherapy share a common focus on emotional experience, the modality used for therapy can be relevant in the design and use of these orientations. Data are in British English.
Early detection of subacute potentially catastrophic illnesses using available data is a clinical imperative, and scores that report risk of imminent events in real time abound. Patients deteriorate ...for a variety of reasons, and it is unlikely that a single predictor such as an abnormal National Early Warning Score will detect all of them equally well. The objective of this study was to test the idea that the diversity of reasons for clinical deterioration leading to ICU transfer mandates multiple targeted predictive models.
Individual chart review to determine the clinical reason for ICU transfer; determination of relative risks of individual vital signs, laboratory tests and cardiorespiratory monitoring measures for prediction of each clinical reason for ICU transfer; and logistic regression modeling for the outcome of ICU transfer for a specific clinical reason.
Cardiac medical-surgical ward; tertiary care academic hospital.
Eight-thousand one-hundred eleven adult patients, 457 of whom were transferred to an ICU for clinical deterioration.
None.
We calculated the contributing relative risks of individual vital signs, laboratory tests and cardiorespiratory monitoring measures for prediction of each clinical reason for ICU transfer, and used logistic regression modeling to calculate receiver operating characteristic areas and relative risks for the outcome of ICU transfer for a specific clinical reason. The reasons for clinical deterioration leading to ICU transfer were varied, as were their predictors. For example, the three most common reasons-respiratory instability, infection and suspected sepsis, and heart failure requiring escalated therapy-had distinct signatures of illness. Statistical models trained to target-specific reasons for ICU transfer performed better than one model targeting combined events.
A single predictive model for clinical deterioration does not perform as well as having multiple models trained for the individual specific clinical events leading to ICU transfer.
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