Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05723120
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2023-01-18
Brief Title:
Development and Validation of the PHYSIOSCORE
Sponsor:
University of Sao Paulo
Organization:
University of Sao Paulo
Study Overview
Official Title:
Development and Validation of the PHYSIOSCORE to Assess the Complexity Level and Physiotherapy Care in Hospitalized Patients
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n110 in each phase The reproducibility was evaluated by re-assessing 110 patients every five days until hospital discharge
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 n110 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 technique1415 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 PaO2FiO2 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 httpwwwfisioescorecom 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
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 technique1415 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 PaO2FiO2 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 httpwwwfisioescorecom 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None