Development and Validation of the PHYSIOSCORE

NCT05723120 | Completed DMC

• 1 other identifier: PHYSIOSCORE
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases; Lung Diseases

Outcome Measures

Primary Outcomes (2)

• Respiratory variables

  "lung function", "breath sounds", "PaO2/FiO2", and "Chest X-ray"

  3 years

• neuromuscular variables

  "muscle strength", "muscle tone" and "postural control"

  3 years

Study Arms (2)

Neuromuscular Score

EXPERIMENTAL

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

Other: Assessment Respiratory and Neuromuscular

Respiratory Score

EXPERIMENTAL

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

Other: Assessment Respiratory and Neuromuscular

Interventions

Assessment Respiratory and Neuromuscular OTHER

Comparative Score

Neuromuscular Score; Respiratory Score

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Alcino Costa Leme

São Paulo, São Paulo, 01155-060, Brazil

Location

Related Publications (1)

• 1. Griffith JR, White KR. The revolution in hospital management. J Healthc Manag. 2005;50(3):170-189; discussion 189-190. 2. Ghasemi M, Ghadiri Nejad M, Bagzibagli K. Knowledge Management Orientation: An Innovative Perspective to Hospital Management. Iran J Public Health. 2017;46(12):1639-1645. 3. Masic I, Miokovic M, Muhamedagic B. Evidence based medicine - new approaches and challenges. Acta Inform Med. 2008;16(4):219-225. 4. Tipping CJ, Young PJ, Romero L, Saxena MK, Dulhunty J, Hodgson CL. A systematic review of measurements of physical function in critically ill adults. Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine. 2012;14(4):302-311. 5. Fernandes LEMea. Recursos humanos em hospitais estaduais gerenciados por organizações sociais de saúde: a lógica do privado. Educação e Saúde. 2018;v. 16(n. 3):955-973. 6. Katia de Miranda Avena RPA. CONTRIBUTION OF MANAGEMENT EDUCATION: CHALLENGES OF THE PHYSIOTHERAPIST TO COMPLY WITH THE JOB MARKET DEMANDS. Braz. J. of Develop. 2020;6(8):55974-55987. 7. Mokkink LB, Terwee CB, Knol DL, et al. Protocol of the COSMIN study: COnsensus-based Standards for the selection of health Measurement INstruments. BMC Med Res Methodol. 2006;6:2. 8. Mokkink LB, Terwee CB, Knol DL, et al. The COSMIN checklist for evaluating the methodological quality of studies on measurement properties: a clarification of its content. BMC Med Res Methodol. 2010;10:22. 9. Burns KE, Duffett M, Kho ME, et al. A guide for the design and conduct of self-administered surveys of clinicians. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne. 2008;179(3):245-252. 10. Bickley LS. Bates - Propedêutica Médica. 12ª edição ed: Guanabara Koogan; 2018. 11. Pereira CAC. Medicina Respiratória. Vol 1 e 2. Primeira Edição ed: Atheneu; 2014. 12. Campbell WW. DeJong's O Exame Neurológico. Vol Seventh Edition: Guanabara Koogan; 2014. 13. Kumaran JCaM. Manual de Raios X de Tórax. Vol 4 Edição: Elsevier Editora Ltda; 2017. 14. Diamond IR, Grant RC, Feldman BM, et al. Defining consensus: a systematic review recommends methodologic criteria for reporting of Delphi studies. Journal of clinical epidemiology. 2014;67(4):401-409. 15. Dalkey N, Helmer O. An Experimental Application of the Delphi Method to the Use of Experts. Manage Sci. 1963;9(3):458-467. 16. Nashef SA, Roques F, Sharples LD, et al. EuroSCORE II. European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery. 2012;41(4):734-744; discussion 744-735. 17. Moreno RP, Metnitz PG, Almeida E, et al. SAPS 3--From evaluation of the patient to evaluation of the intensive care unit. Part 2: Development of a prognostic model for hospital mortality at ICU admission. Intensive care medicine. 2005;31(10):1345-1355. 18. Bisbe E, Sabate S, Castillo J, Basora M, Canet J. Postoperative complications related to allogeneic transfusion in major surgery. The multicenter, prospective study ARISCAT. European journal of anaesthesiology. 2010;27(1):110-110. 19. Zegers M, de Bruijne MC, Wagner C, Groenewegen PP, van der Wal G, de Vet HC. The inter-rater agreement of retrospective assessments of adverse events does not improve with two reviewers per patient record. Journal of clinical epidemiology. 2010;63(1):94-102. 20. Warrens MJ. Chance-corrected measures for 2 x 2 tables that coincide with weighted kappa. Br J Math Stat Psychol. 2011;64(Pt 2):355-365. 21. Malmoon Z, Tourani S, Maleki M, Jafari M. Future competencies for hospital management in developing countries: Systematic review. Med J Islam Repub Iran. 2020;34:15. 22. Franco SS, Malbouisson LMS, Grinberg M, Feltrim MIZ. A propose of pulmonary dysfunction stratification after valve surgery by physiotherapeutic assistance level. Rev Bras Cir Cardiov. 2015;30(2):188-197. 23. Schweickert WD, Pohlman MC, Pohlman AS, et al. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009;373(9678):1874-1882. 24. Corner EJ, Wood H, Englebretsen C, et al. The Chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy. 2013;99(1):33-41. 25. Perme C, Nawa RK, Winkelman C, Masud F. A tool to assess mobility status in critically ill patients: the Perme Intensive Care Unit Mobility Score. Methodist DeBakey cardiovascular journal. 2014;10(1):41-49. 26. Canet J, Mazo V. Postoperative pulmonary complications. Minerva anestesiologica. 2010;76(2):138-143. 27. Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113(6):1338-1350.

  BACKGROUND

MeSH Terms

Conditions

Heart Diseases; Lung Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases

Study Officials

• Alcino C Leme, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Physiotherapist of Surgical ICU

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 10, 2023
• Study Start: January 10, 2018
• Primary Completion: January 10, 2021
• Study Completion: October 10, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)