Development and Validation of the PHYSIOSCORE
Condition: Heart Diseases; Lung Diseases
MeSH terms: Lung Diseases; Heart Diseases
Study type: Interventional

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.
    

Intervention name(s): Assessment Respiratory and Neuromuscular
Intervention type(s): Other
Intervention description(s): Comparative Score
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research