Virtual Reality for advanced cancer patients assisted at home: A randomized controlled interventional study.

OBJECTIVE: Virtual Reality (VR) has been demonstrated to be an effective option for integrating psychological interventions in different therapeutic settings. This randomized controlled interventional study aims to assess the effects of VR, compared to tablet controlled intervention, on anxiety, depression, pain, and short-term psychophysical symptoms in advanced cancer patients assisted at home. METHODS: Participants were provided with a VR headset or a tablet (TAB) for 4 days. On the first and last day, anxiety and depression were measured by Hospital Anxiety and Depression Scale and pain by Brief Pain Inventory. Before and after each VR and tablet session, symptoms were collected by the Edmonton Symptom Assessment Scale (ESAS). RESULTS: Fifty-three patients (27 VR vs. 26 TAB) completed the study. Anxiety significantly decreased in the VR group after the 4-day intervention. The analysis of ESAS showed a significant improvement in pain (p = 0.013), tiredness (p < 0.001), and anxiety (p = 0.013) for TAB group, and a significant reduction in tiredness (p < 0.001) in the VR group. CONCLUSIONS: Technological and user-friendly tools, such as VR and tablets, might be integrated with traditional psychological interventions to improve anxiety and cancer-related short-term symptoms. Further studies are needed to better consolidate the possible beneficial effects of VR.

Wrist Photoplethysmography Signal Quality Assessment for Reliable Heart Rate Estimate and Morphological Analysis.

Photoplethysmographic (PPG) signals are mainly employed for heart rate estimation but are also fascinating candidates in the search for cardiovascular biomarkers. However, their high susceptibility to motion artifacts can lower their morphological quality and, hence, affect the reliability of the extracted information. Low reliability is particularly relevant when signals are recorded in a real-world context, during daily life activities. We aim to develop two classifiers to identify PPG pulses suitable for heart rate estimation (Basic-quality classifier) and morphological analysis (High-quality classifier). We collected wrist PPG data from 31 participants over a 24 h period. We defined four activity ranges based on accelerometer data and randomly selected an equal number of PPG pulses from each range to train and test the classifiers. Independent raters labeled the pulses into three quality levels. Nineteen features, including nine novel features, were extracted from PPG pulses and accelerometer signals. We conducted ten-fold cross-validation on the training set (70%) to optimize hyperparameters of five machine learning algorithms and a neural network, and the remaining 30% was used to test the algorithms. Performances were evaluated using the full features and a reduced set, obtained downstream of feature selection methods. Best performances for both Basic- and High-quality classifiers were achieved using a Support Vector Machine (Acc: 0.96 and 0.97, respectively). Both classifiers outperformed comparable state-of-the-art classifiers. Implementing automatic signal quality assessment methods is essential to improve the reliability of PPG parameters and broaden their applicability in a real-world context.

FHIR-standardized data collection on the clinical rehabilitation pathway of trans-femoral amputation patients.

Lower limb amputation is a medical intervention which causes motor disability and may compromise quality of life. Several factors determine patients' health outcomes, including an appropriate prosthetic provision and an effective rehabilitation program, necessitating a thorough quantitative observation through different data sources. In this context, the role of interoperability becomes essential, facilitating the reuse of real-world data through the provision of structured and easily accessible databases. This study introduces a comprehensive 10-year dataset encompassing clinical features, mobility measurements, and prosthetic knees of 1006 trans-femoral amputees during 1962 hospital stays for rehabilitation. The dataset is made available in both comma-separated values (CSV) format and HL7 Fast Healthcare Interoperability Resources (FHIR)-based representation, ensuring broad utility and compatibility for researchers and healthcare practitioners. This initiative contributes to advancing community understanding of post-amputation rehabilitation and underscores the significance of interoperability in promoting seamless data sharing for meaningful insights into healthcare outcomes.

Feasibility interventional study investigating PAIN in neurorehabilitation through wearabLE SensorS (PAINLESS): a study protocol.

INTRODUCTION: Millions of people survive injuries to the central or peripheral nervous system for which neurorehabilitation is required. In addition to the physical and cognitive impairments, many neurorehabilitation patients experience pain, often not widely recognised and inadequately treated. This is particularly true for multiple sclerosis (MS) patients, for whom pain is one of the most common symptoms. In clinical practice, pain assessment is usually conducted based on a subjective estimate. This approach can lead to inaccurate evaluations due to the influence of numerous factors, including emotional or cognitive aspects. To date, no objective and simple to use clinical methods allow objective quantification of pain and the diagnostic differentiation between the two main types of pain (nociceptive vs neuropathic). Wearable technologies and artificial intelligence (AI) have the potential to bridge this gap by continuously monitoring patients' health parameters and extracting meaningful information from them. Therefore, we propose to develop a new automatic AI-powered tool to assess pain and its characteristics during neurorehabilitation treatments using physiological signals collected by wearable sensors. METHODS AND ANALYSIS: We aim to recruit 15 participants suffering from MS undergoing physiotherapy treatment. During the study, participants will wear a wristband for three consecutive days and be monitored before and after their physiotherapy sessions. Measurement of traditionally used pain assessment questionnaires and scales (ie, painDETECT, Doleur Neuropathique 4 Questions, EuroQoL-5-dimension-3-level) and physiological signals (photoplethysmography, electrodermal activity, skin temperature, accelerometer data) will be collected. Relevant parameters from physiological signals will be identified, and AI algorithms will be used to develop automatic classification methods. ETHICS AND DISSEMINATION: The study has been approved by the local Ethical Committee (285-2022-SPER-AUSLBO). Participants are required to provide written informed consent. The results will be disseminated through contributions to international conferences and scientific journals, and they will also be included in a doctoral dissertation. TRIAL REGISTRATION NUMBER: NCT05747040.

Quality Assessment and Morphological Analysis of Photoplethysmography in Daily Life.

The photoplethysmographic (PPG) signal has been applied in various research fields, with promising results for its future clinical application. However, there are several sources of variability that, if not adequately controlled, can hamper its application in pervasive monitoring contexts. This study assessed and characterized the impact of several sources of variability, such as physical activity, age, sex, and health state on PPG signal quality and PPG waveform parameters (Rise Time, Pulse Amplitude, Pulse Time, Reflection Index, Delta T, and DiastolicAmplitude). We analyzed 31 24 h recordings by as many participants (19 healthy subjects and 12 oncological patients) with a wristband wearable device, selecting a set of PPG pulses labeled with three different quality levels. We implemented a Multinomial Logistic Regression (MLR) model to evaluate the impact of the aforementioned factors on PPG signal quality. We then extracted six parameters only on higher-quality PPG pulses and evaluated the influence of physical activity, age, sex, and health state on these parameters with Generalized Linear Mixed Effects Models (GLMM). We found that physical activity has a detrimental effect on PPG signal quality quality (94% of pulses with good quality when the subject is at rest vs. 9% during intense activity), and that health state affects the percentage of available PPG pulses of the best quality (at rest, 44% for healthy subjects vs. 13% for oncological patients). Most of the extracted parameters are influenced by physical activity and health state, while age significantly impacts two parameters related to arterial stiffness. These results can help expand the awareness that accurate, reliable information extracted from PPG signals can be reached by tackling and modeling different sources of inaccuracy.

Length of Stay Analysis of COVID-19 Hospitalizations Using a Count Regression Model and Quantile Regression: A Study in Bologna, Italy.

This study aimed to identify and explore the hospital admission risk factors associated with the length of stay (LoS) by applying a relatively novel statistical method for count data using predictors among COVID-19 patients in Bologna, Italy. The second goal of this study was to model the LoS of COVID patients to understand which covariates significantly influenced it and identify the potential risk factors associated with LoS in Bolognese hospitals from 1 February 2020 to 10 May 2021. The clinical settings we focused on were the Intensive Care Unit (ICU) and ordinary hospitalization, including low-intensity stays. We used Poisson, negative binomial (NB), Hurdle-Poisson, and Hurdle-NB regression models to model the LoS. The fitted models were compared using the Akaike information criterion (AIC), Vuong's test criteria, and Rootograms. We also used quantile regression to model the effects of covariates on the quantile values of the response variable (LoS) using a Poisson distribution, and to explore a range of conditional quantile functions, thereby exposing various forms of conditional heterogeneity and controlling for unobserved individual characteristics. Based on the chosen performance criteria, Hurdle-NB provided the best fit. As an output from the model, we found significant changes in average LoS for each predictor. Compared with ordinary hospitalization and low-intensity stays, the ICU setting increased the average LoS by 1.84-fold. Being hospitalized in long-term hospitals was another contributing factor for LoS, increasing the average LoS by 1.58 compared with regular hospitals. When compared with the age group [50, 60) chosen as the reference, the average LoS decreased in the age groups [0, 10), [30, 40), and [40, 50), and increased in the oldest age group [80, 102). Compared with the second wave, which was chosen as the reference, the third wave did not significantly affect the average LoS, whereas it increased by 1.11-fold during the first wave and decreased by 0.77-fold during out-wave periods. The results of the quantile regression showed that covariates related to the ICU setting, hospitals with longer hospitalization, the first wave, and the out-waves were statistically significant for all the modeled quantiles. The results obtained from our study can help us to focus on the risk factors that lead to an increased LoS among COVID-19 patients and benchmark different models that can be adopted for these analyses.

Physiological responses to pain in cancer patients: A systematic review.

BACKGROUND AND OBJECTIVE: Pain is one of the most debilitating symptoms in persons with cancer. Still, its assessment is often neglected both by patients and healthcare professionals. There is increasing interest in conducting pain assessment and monitoring via physiological signals that promise to overcome the limitations of state-of-the-art pain assessment tools. This systematic review aims to evaluate existing experimental studies to identify the most promising methods and results for objectively quantifying cancer patients' pain experience. METHODS: Four electronic databases (Pubmed, Compendex, Scopus, Web of Science) were systematically searched for articles published up to October 2020. RESULTS: Fourteen studies (528 participants) were included in the review. The selected studies analyzed seven physiological signals. Blood pressure and ECG were the most used signals. Sixteen physiological parameters showed significant changes in association with pain. The studies were fairly consistent in stating that heart rate, the low-frequency to high-frequency component ratio (LF/HF), and systolic blood pressure positively correlate with the pain. CONCLUSIONS: Current evidence supports the hypothesis that physiological signals can help objectively quantify, at least in part, cancer patients' pain experience. While there is much more to be done to obtain a reliable pain assessment method, this review takes an essential first step by highlighting issues that should be taken into account in future research: use of a wearable device for pervasive recording in a real-world context, implementation of a big-data approach possibly supported by AI, including multiple stratification factors (e.g., cancer site and stage, source of pain, demographic and psychosocial data), and better-defined recording procedures. Improved methods and algorithms could then become valuable add-ons in taking charge of cancer patients.

Degree of Safety Against Falls Provided by 4 Different Prosthetic Knee Types in People With Transfemoral Amputation: A Retrospective Observational Study.

OBJECTIVE: People with transfemoral amputation have balance and mobility problems and are at high risk of falling. An adequate prosthetic prescription is essential to maximize their functional levels and enhance their quality of life. This study aimed to evaluate the degree of safety against falls offered by different prosthetic knees. METHODS: A retrospective study was conducted using data from a center for prosthetic fitting and rehabilitation. Eligible individuals were adults with unilateral transfemoral amputation or knee disarticulation. The prosthetic knee models were grouped into 4 categories: locked knees, articulating mechanical knees (AMKs), fluid-controlled knees (FK), and microprocessor-controlled knees (MPK). The outcome was the number of falls experienced during inpatient rehabilitation while wearing the prosthesis. Association analyses were performed with mixed-effect Poisson models. Propensity score weighting was used to adjust causal estimates for participant confounding factors. RESULTS: Data on 1486 hospitalizations of 815 individuals were analyzed. Most hospitalizations (77.4%) were related to individuals with amputation due to trauma. After propensity score weighting, the knee category was significantly associated with falls. People with FK had the highest rate of falling (incidence rate = 2.81 falls per 1000 patient days, 95% CI = 1.96 to 4.02). FK significantly increased the risk of falling compared with MPK (incidence rate ratio [IRRFK-MPK] = 2.44, 95% CI = 1.20 to 4.96). No other comparison among knee categories was significant. CONCLUSIONS: Fluid-controlled prosthetic knees expose inpatients with transfemoral amputation to higher incidence of falling than MPK during rehabilitation training. IMPACT: These findings can guide clinicians in the selection of safe prostheses and reduction of falls in people with transfemoral amputation during inpatient rehabilitation.

Automatic pain assessment on cancer patients using physiological signals recorded in real-world contexts.

Pain assessment represents the first fundamental stage for proper pain management, but currently, methods applied in clinical practice often lack in providing a satisfying characterization of the pain experience. Automatic methods based on the analysis of physiological signals (e.g., photoplethysmography, electrodermal activity) promise to overcome these limitations, also providing the possibility to record these signals through wearable devices, thus capturing the physiological response in everyday life. After applying preprocessing, feature extraction and feature selection methods, we tested several machine learning algorithms to develop an automatic classifier fed with physiological signals recorded in real-world contexts and pain ratings from 21 cancer patients. The best algorithm achieved up to 72% accuracy. Although performance can be improved by enlarging the dataset, preliminary results proved the feasibility of assessing pain by using physiological signals recorded in real-world contexts.

Virtual Reality in Home Palliative Care: Brief Report on the Effect on Cancer-Related Symptomatology.

Virtual reality (VR) has been used as a complementary therapy for managing psychological and physical symptoms in cancer patients. In palliative care, the evidence about the use of VR is still inadequate. This study aims to assess the effect of an immersive VR-based intervention conducted at home on anxiety, depression, and pain over 4days and to evaluate the short-term effect of VR sessions on cancer-related symptomatology. Participants were advanced cancer patients assisted at home who were provided with a VR headset for 4days. On days one and four, anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS) and pain by the Brief Pain Inventory (BPI). Before and after each VR session, symptoms were collected by the Edmonton Symptom Assessment Scale (ESAS). Participants wore a smart wristband measuring physiological signals associated with pain, anxiety, and depression. Fourteen patients (mean age 47.2±14.2years) were recruited. Anxiety, depression (HADS), and pain (BPI) did not change significantly between days one and four. However, the ESAS items related to pain, depression, anxiety, well-being, and shortness of breath collected immediately after the VR sessions showed a significant improvement (p<0.01). A progressive reduction in electrodermal activity has been observed comparing the recordings before, during, and after the VR sessions, although these changes were not statistically significant. This brief research report supports the idea that VR could represent a suitable complementary tool for psychological treatment in advanced cancer patients assisted at home.