Usability Testing of a New Digital Integrated Health Ecosystem (PainRELife) for the Clinical Management of Chronic Pain in Patients With Early Breast Cancer: Protocol for a Pilot Study.

BACKGROUND: Chronic pain (CP) and its management are critical issues in the care pathway of patients with breast cancer. Considering the complexity of CP experience in cancer, the international scientific community has advocated identifying cutting-edge approaches for CP management. Recent advances in the field of health technology enable the adoption of a novel approach to care management by developing integrated ecosystems and mobile health apps. OBJECTIVE: The primary end point of this pilot study is to evaluate patients' usability experience at 3 months of a new digital and integrated technological ecosystem, PainRELife, for CP in a sample of patients with breast cancer. The PainRELife ecosystem is composed of 3 main technological assets integrated into a single digital ecosystem: Fast Healthcare Interoperability Resources-based cloud platform (Nu platform) that enables care pathway definition and data collection; a big data infrastructure connected to the Fast Healthcare Interoperability Resources server that analyzes data and implements dynamic dashboards for aggregate data visualization; and an ecosystem of personalized applications for patient-reported outcomes collection, digital delivery of interventions and tailored information, and decision support of patients and caregivers (PainRELife app). METHODS: This is an observational, prospective pilot study. Twenty patients with early breast cancer and chronic pain will be enrolled at the European Institute of Oncology at the Division of Medical Senology and the Division of Pain Therapy and Palliative Care. Each patient will use the PainRELife mobile app for 3 months, during which data extracted from the questionnaires will be sent to the Nu Platform that health care professionals will manage. This pilot study is nested in a large-scale project named "PainRELife," which aims to develop a cloud technology platform to interoperate with institutional systems and patients' devices to collect integrated health care data. The study received approval from the Ethical Committee of the European Cancer Institute in December 2021 (number R1597/21-IEO 1701). RESULTS: The recruitment process started in May 2022 and ended in October 2022. CONCLUSIONS: The new integrated technological ecosystems might be considered an encouraging affordance to enhance a patient-centered approach to managing patients with cancer. This pilot study will inform about which features the health technological ecosystems should have to be used by cancer patients to manage CP. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41216.

Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q): development and implementation of an instrument to evaluate patients' perception during training.

BACKGROUND: The introduction of technology-assisted rehabilitation (TAR) uncovers promising challenges for the treatment of motor disorders, particularly if combined with exergaming. Patients with neurological diseases have proved to benefit from TAR, improving their performance in several activities. However, the subjective perception of the device has never been fully addressed, being a conditioning factor for its use. The aims of the study were: (a) to develop a questionnaire on patients' personal experience with TAR and exergames in a real-world clinical setting; (b) to administer the questionnaire to a pilot group of neurologic patients to assess its feasibility and statistical properties. METHODS: A self-administrable and close-ended questionnaire, Technology Assisted Rehabilitation Patient Perception Questionnaire (TARPP-Q), designed by a multidisciplinary team, was developed in Italian through a Delphi procedure. An English translation has been developed with consensus, for understandability purposes. The ultimate version of the questionnaire was constituted of 10 questions (5 with multiple answers), totalling 29 items, exploring the patient's performance and personal experience with TAR with Augmented Performance Feedback. TARPP-Q was then administered pre-post training in an observational, feasible, multi-centric study. The study involved in-patients aged between 18 and 85 with neurological diseases, admitted for rehabilitation with TAR (upper limb or gait). FIM scale was run to control functional performance. RESULTS: Forty-four patients were included in the study. All patients answered the TARPP-Q autonomously. There were no unaccounted answers. Exploratory factor analyses identified 4 factors: Positive attitude, Usability, Hindrance perception, and Distress. Internal consistency was measured at T0. The values of Cronbach's alpha ranged from 0.72 (Distress) to 0.92 (Positive attitude). Functional Independence Measure (FIM®) scores and all TARPP-Q factors (Positive attitude, Usability, Hindrance perception, except for Distress (p = 0.11), significantly improved at the end of the treatment. A significant positive correlation between Positive attitude and Usability was also recorded. CONCLUSIONS: The TARPP-Q highlights the importance of patients' personal experience with TAR and exergaming. Large-scale applications of this questionnaire may clarify the role of patients' perception of training effectiveness, helping to customize devices and interventions.

Lesson learned from an international training program on patients medication adherence for healthcare professionals.

SUMMARY: Objective. Healthcare professionals play a crucial role for promoting medication adherence in older adults. This research aimed to assess changes in professionals' opinions about medication adherence after attending a course, collecting suggestions for future educational programs. Method. A one-week course on medication adherence in older adults was held involving 32 healthcare professionals and students from Italy, Portugal and Poland as part of the Erasmus+ Skills4Adherence Project. Prior to and at the end of the course, participants provided three keyword answers through a Google Form. Responses were collectively discussed and commented on. Results. At the end of the course a general tendency to put more attention on patient's beliefs and engagement was revealed. The caregivers' role was also underlined. As to suggestions for education, three keywords were considered not enough to characterize adherence issues. Conversely, professionals considered collective discussions and roleplaying to be effective for increasing awareness on this theme. Discussion and conclusion. Several changes in healthcare professionals' opinions regarding determinants of medicationadherence were revealed after this dedicated course. Overall, multidisciplinary and practical training programs should be proposed for increasing healthcare professionals' awareness of factors impacting on medication adherence in older adults.

Methodological features of quantitative studies on medication adherence in older patients with chronic morbidity: A systematic review.

OBJECTIVES: The growing number of chronic, multimorbid older adults encourages healthcare systems to cope with polypharmacy and non-adherence. However, methodology on how to provide effective interventions to enhance medication adherence is still object of debate. METHODS: To describe methodological features of quantitative studies concerning older adults' medication adherence, by means of a PRISMA systematic review (Scopus, PubMed, Medline). A specific focus was devoted to theoretical models and to the ABC Taxonomy model, as stated by the EMERGE guidelines. RESULTS: 55 papers were included. Most of the studies were conducted using randomized control trials (63.6%) and focused on a single disease only (72.7%). Most of the interventions were provided by a single professional figure (70.9%). Medication adherence was mainly evaluated by means of questionnaires (61.8%) and by clinical records (30.9%). Sixteen studies considered a theoretical model in the intervention framework. The Initiation phase (ABC Taxonomy) was the most neglected. CONCLUSIONS: Future studies upon medication adherence should account real-life challenges such as multimorbidity, polypharmacy and interdisciplinarity, analyzing adherence as a complex, holistic process. PRACTICE IMPLICATIONS: Theoretical models may be useful to enhance the soundness of the results, to ease their comparability, to calibrate tailored strategies and to plan patient-centered interventions.

Implementation of a real-world based ICF set for the rehabilitation of respiratory diseases: a pilot study.

BACKGROUND: International Classification Functioning (ICF) Core Sets represent a holistic approach to functioning within rehabilitation field. Information-reporting efficacy of a rehabilitation-based Respiratory ICF set applied on a large scale throughout the ICS Maugeri network was tested. METHODS: A prospective multi-center study (May-November 2018) was conducted for all respiratory inpatients consecutively admitted for rehabilitation. Doctors, physiotherapists, psychologists, nurses used an electronic Respiratory ICF set (33 items among the ICF body functions, activity and participations components) at admission and at discharge to assess the disability changes. The ICF report qualifiers, from 0 (no impairment) to 4 (maximum impairment), guided clinical, diagnostic and rehabilitation prescriptions. RESULTS: 1886 patients (69.6±10.8 years; M=1045) were admitted (589 chronic obstructive pulmonary disease, 494 chronic respiratory failure [CRF], 21 prolonged mechanical ventilation [PMV], 496 with other respiratory diseases), of whom 15 died, and 117 were transferred to acute care. The mean length of stay was 23.1±11.8 days (range 1-122). The mean time to fill in the ICF set was 23.16±0.70 min. The rate of filled charts improved from 16% in May to 100% in November. The baseline distribution of the more severe qualifiers (>2) progressively increased from the whole sample to the PMV subgroup. After rehabilitation, in the whole sample and in the CRF and PMV subgroups, the severity qualifiers significantly decreased (P<0.0001), showing a positive effect of the intervention on patients' disability. CONCLUSIONS: Routine use of a Respiratory ICF set for chronic respiratory diseases helps to prepare a personalized rehabilitation program discriminating disability level in different respiratory diseases and assessing disability outcomes pre-post rehabilitation.

[Towards a baseline ontology for information technology in rehabilitation medicine: the nomenclator of the rehabilitation procedures]. / Verso un'ontologia di riferimento per i sistemi informativi in medicina riabilitativa: il nomenclatore delle prestazioni riabilitative.

SUMMARY: One of the main aims of Healthcare Information Technology is the safe and efficient management of significant amounts of clinical data. Now more than ever, such goal requires the creation of common semantics to ontologically organize knowledge enclosed in databases. By means of the application of the WHO ICD-ICF frameworks, the ensemble of rehabilitative activities lead in all the Maugeri institutes in Italy, has been formally standardized to create a Nomenclator, with the aim to: a) support clinicians in the definition of the individualized Care Pathway; b) program, optimize and maximize patient's rehabilitation activities, according to clinical and organizational requirements; c) qualitatively and quantitatively report the daily health-care professionals' workflows; d) provide a structured and detailed medical record meeting appropriateness requirements. In this regard, the application of the ICD-ICF framework as a baseline ontology, paves the path to an ongoing tracking of the rehabilitation processes, leading to a more accurate description of patient's functioning profile. The upcoming challenge for rehabilitation is the ultimate overcoming of a solely epidemiological perspective, in order to embrace a holistic approach, fostered by ontologically-based information technologies.

[The ICD-ICF outpatient pathway in occupational therapy]. / Il percorso ambulatoriale ICD-ICF in terapia occupazionale.

SUMMARY: The Complex Ambulatory Macroactivity (MAC, Macroattività Ambulatoriale Complessa) has recently been included among the therapeutic and diagnostic Specialized Rehabilitation services issued by the Lombardy Region health institutes. Within Maugeri Scientific Clinical Institutes, our Occupational Physiatrics and Ergonomics Service is actively involved in the organic redefinition of rehabilitative pathways in the light of functional and patient-centered interpretation, typical of ICF (International Classification of Functioning). The article describes the assumptions, criteria and procedures that support the MAC system, proposing a modeling that can be inserted into the modern and complex system of health services.

[Digitalisation and clinical care pathways in rehabilitation medicine: a possible integration from the goal-planning and the rehabilitation programme design to the evaluation of clinical outcomes.] / ICF, digitalizzazione e percorsi clinico-assistenziali in medicina riabilitativa: una integrazione possibile dalla definizione degli obiettivi alla stesura del programma riabilitativo, alla valutazione dei risultati.

OBJECTIVES: In the light of the growing complexity featuring the contemporary world, a future challenge is represented by the maintenance of the humanization of healthcare, along with the necessity of a high specificity personalized treatment, in a growing emergency of lack of resources. Furthermore, the ongoing digital revolution spreading in every productive sector involves the health-care system as well, playing a crucial role for the goals of the specialized care-related prevention-treatment-rehabilitation approach of the Rehabilitation Medicine. However, the digitalization of clinical data is not to be considered as a mere tout-court necessity, but it deserves to be planned and carried out with consistent awareness: the digital transformation calls for a theoretical paradigm which, together with a shared language, will be able to embrace its multilevel complexity, taking into account the patient needs, the clinical care pathways and the administrative requests. METHODS: In the present work the potentialities of the WHO ICF model (International Classification of Functioning, Disability and Health) will be described. In particular, will be discussed the role of the ICF in representing the keystone able to connect the ICD-9-CM classification, the clinical care pathways, the individualized rehabilitation project and program and their digital implementation. RESULTS: Hence, each step of the process that led the implementation of the biopsychosocial model in the ICF Maugeri workflows will be presented, as well as the critical issues related to the digitalisation process and the strengths in safeguarding the patients' wellbeing.

Motor and psychosocial impact of robot-assisted gait training in a real-world rehabilitation setting: A pilot study.

In the last decade robotic devices have been applied in rehabilitation to overcome walking disability in neurologic diseases with promising results. Robot assisted gait training (RAGT) using the Lokomat seems not only to improve gait parameters but also the perception of well-being. Data on the psychosocial patient-robot impact are limited, in particular in the real-world of RAGT, in the rehabilitation setting. During rehabilitation training, the Lokomat can be considered an "assistive device for movement". This allowed the use of the Psychosocial Impact of Assistive Device Scale- PIADS to describe patient interaction with the Lokomat. The primary aim of this pilot study was to evaluate the psychosocial impact of the Lokomat in an in-patient rehabilitation setting using the PIADS; secondary aims were to assess whether the psychosocial impact of RAGT is different between pathological sub-groups and if the Lokomat influenced functional variables (Functional Independence Measure scale-FIM and parameters provided by the Lokomat itself). Thirty-nine consecutive patients (69% males, 54.0±18.0 years) eligible for Lokomat training, with etiologically heterogeneous walking disabilities (Parkinson's Disease, n = 10; Spinal Cord Injury, n = 21; Ictus Event, n = 8) were enrolled. Patients were assessed with the FIM before and after rehabilitation with Lokomat, and the PIADS was administered after the rehabilitative period with Lokomat. Overall the PIADS score was positive (35.8±21.6), as well as the three sub-scales, pertaining to "ability", "adaptability" and "self-esteem" (17.2±10.4, 8.9±5.5 and 10.1±6.6 respectively) with no between-group differences. All patients significantly improved in gait measure and motor FIM scale (difference after-before treatment values: 11.7±9.8 and 11.2±10.3 respectively), increased treadmill speed (0.4 ± 0.2m/s), reduced body weight support (-14.0±9.5%) and guidance force (-13.1 ± 10.7%). This pilot study indicates that Lokomat, in a real-world in-patient setting, may have a generalised approval, independent of disease, underlining the importance of the psycho-social framework for patients training with assistive robotic-devices.