Clinical trial NCT05723120: Development and Validation of the PHYSIOSCORE
Official title: Development and Validation of the PHYSIOSCORE to Assess the Complexity Level and Physiotherapy Care in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Lung Diseases
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Abstract Background: Several medical scores have been developed to support clinical support and predict complications in hospitalized patients. However, there is no scale for physical therapy (PT) support.

Objetivo: To develop a scale to determine the level of complexity and PT support in hospitalized patients.

Methods: This cross-sectional study was performed in a tertiary hospital and developed in three distinctive phases: scale (PHYSIOSCORE) development, validation, and testing. The development phase was performed with ten senior PTs using the Delphi methodology. The validation and testing phases were performed by assessing 220 patients (n=110 in each phase). The reproducibility was evaluated by re-assessing 110 patients every five days until hospital discharge.

Detailed description: Phase 1. Questionnaire validation construct. The committee comprised ten specialist physical therapists with more than ten years of experience in hospital care. The questionnaires were developed based on variables used in clinical practice. The committee agreed that the scale needed to meet four objectives7: (i) be composed of variables used by physical therapists working in the hospital; (ii) have valid content for hospitalized adult patients8; (iii) be viable9 (fast and easy to use); and (iv) have inter-examiner reliability.

In the first meeting, every committee member was asked to report relevant variables. After that, the committee was asked to classify each informed variable10-13 as unimportant, important, or essential for the physical therapy assessment to provide quality care to the patient during hospitalization. The validity of this construct was performed using the Delphi technique14,15, and the consensus was defined with a minimum percentage of at least 75% agreement as important or essential. Only the items that reached consensus were retained for the second round.

In the second round, the committee members were asked to re-evaluate each item and classify them on a 10-point numerical scale. Where the score 0 represented the item within the normal range and 5, 7, or 10 points, depending on the item analyzed, the condition that most deviated from normality and consequently would result in greater attention and greater complexity of physical therapy care (Appendix B). The consensus was defined with a minimum percentage of at least 75% agreement among the participants for each item.

The final version of the PHYSIOSCORE was composed of 106 items, divided into three domains: respiratory, imaging, and neuromuscular. For patients with spontaneous breathing or noninvasive mechanical ventilation, the PHYSIOSCORE consisted of six items: pulmonary function, pulmonary sound, need for airway clearance, peripheral oxygen saturation (SpO2), respiratory rate (f), and imaging examination. For patients on invasive mechanical ventilation, the PHYSIOSCORE was also composed of six items: pulmonary sound, PaO2/FiO2 ratio, patient-mechanical ventilator interaction, measurements of pulmonary mechanics, need for airway clearance, and imaging examination (Appendix C). The imaging examination was divided into four segments: pulmonary parenchyma, pleura, vascular plot, and expandability (Appendix D).

The neuromuscular evaluation consisted of six items: neuropsychological, muscle strength and tone, postural control, neuromotor coordination, and walking. (Appendix E).

In the third round, the committee reviewed the PHYSIOSCORE, seeking redundancies and ensuring the final writing of all items and domains.

Phase 2. Concordance and Interrater Reliability This phase was performed by another ten physical therapists (not involved in phase 1) with at least five years of experience in the hospital setting. In addition, the online calculator was developed to include the 106 items divided into three main domains of PHYSIOESCORE (http://www.fisioescore.com, in Portuguese). All physical therapists received prior training to standardize the use of the scale.

The interrater agreement and reliability were established following a prospective and observational single-center study. A cohort of 110 patients hospitalized for clinical or surgical cardiac conditions was recruited from March to June 2019. Patients were selected with the following inclusion criteria: age between 18 and 80 years, both sexes, and pre- or postoperative cardiac surgery. The exclusion criteria were as follows: participating in another study, being unable to understand and perform any of the proposed tests, and cardiovascular instability. Before participating in the study, all patients signed a written informed consent form.

Patients undergoing spontaneous ventilation, noninvasive mechanical ventilation, or invasive mechanical ventilation were assessed by two physical therapists with a minimum interval of 15 minutes between them. There was no communication between the physical therapists before, during, or after the assessments. Patients were also evaluated by the EuroSCORE16, SAPS 317, and ARISCAT18 scales. They were evaluated three times during hospitalization: at protocol admission, after five and ten days, or at hospital discharge, whichever occurred first. The surgical patients were also evaluated three times: immediately postoperative, at ICU discharge, and seven days later or at hospital discharge, whichever occurred first.

In addition, patients' characteristics at hospital admission were also analyzed, including demographic characteristics, clinical signs and symptoms, imaging, laboratory findings, and medical history.

Phase 3 Clinical Validation of the Instrument A total of 110 consecutive clinical and surgical patients were selected. Patients inclusion and exclusion criteria were similar to those evaluated in phase 2. This phase was performed in two stages. Initially, the PHYSIOSCORE was applied to assess the level of attention and complexity of physical therapy care by one professional. Then, a second physical therapist with at least five years of experience performed respiratory and neuromuscular physical therapy. The time spent evaluating respiratory and neuromuscular physical therapist care and registering electronic medical records were all timed.

Eligibility criteria: Inclusion Criteria

* age between 18 and 80 years
* both sexes
* pre- or postoperative cardiac surgery.

Exclusion Criteria

* participating in another study
* unable to understand and perform any of the proposed tests
* cardiovascular instability.

Primary outcomes:
measure: Respiratory variables
timeFrame: 3 years
measure: neuromuscular variables
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Alcino Costa Leme
state: São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Alcino C Leme, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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