FSS Icu

Online Clinical Investigations
Functional Status Score for the ICU: An

International Clinimetric Analysis of Validity,
Responsiveness, and Minimal Important Difference
Minxuan Huang, ScM1,2; Kitty S. Chan, PhD3; Jennifer M. Zanni, PT, DScPT4; Selina M. Parry, PhD5;
Saint-Clair G. B. Neto, PT6,7,8; Jose A. A. Neto, MSc, PT7,8; Vinicius Z. M. da Silva, MSc, PT9,10;
Michelle E. Kho, PT, PhD4,11; Dale M. Needham, FCPA, MD, PhD1,2,4
1
Outcome After Critical Illness and Surgery (OACIS) Group, Johns Objectives: To evaluate the internal consistency, validity, respon-
Hopkins University School of Medicine, Baltimore, MD. siveness, and minimal important difference of the Functional Sta-
2
Division of Pulmonary and Critical Care Medicine, Department of Medicine, tus Score for the ICU, a physical function measure designed for
Johns Hopkins U niversity School of Medicine, Baltimore, MD.
the ICU.
3
Department of Health Policy and Management, Johns Hopkins
Bloomberg School of Public Health, Baltimore, MD. Design: Clinimetric analysis.
4
Department of Physical Medicine and Rehabilitation, Johns Hopkins Settings: Five international datasets from the United States, Aus-
University, Baltimore, MD. tralia, and Brazil.
5
Department of Physiotherapy, School of Health Sciences, University of Patients: Eight hundred nineteen ICU patients.
Melbourne, Melbourne, VIC, Australia. Intervention: None.
6
Department of Physical Therapy, Universidade Catolica de Brasilia, Measurements and Main Results: Clinimetric analyses were ini-
Brasilia, Brazil.
tially conducted separately for each data source and time point
7
Department of Physical Therapy, Hospital Santa Luzia, Brasilia, Brazil.
to examine generalizability of findings, with pooled analyses per-
8
Department of Research and Education, D'OR Institute, Brasilia, Brazil.
formed thereafter to increase power of analyses. The Functional
9
Health Sciences Program, Escola Superior de Ciencias da Saude,
Brasilia, Brazil. Status Score for the ICU demonstrated good to excellent inter-
10
Department of Physical Therapy, Hospital de Base do Distrito Federal, nal consistency. There was good convergent and discriminant
Brasilia, Brazil. validity, with significant and positive correlations (r = 0.30–0.95)
11
School of Rehabilitation Science, McMaster University, Hamilton, ON, between Functional Status Score for the ICU and other physi-
Canada. cal function measures, and generally weaker correlations with
Dr. Huang had full access to all of the data in the study and takes responsibil- nonphysical measures (|r| = 0.01–0.70). Known group valid-
ity for the integrity of the data and the accuracy of the data analysis. All authors
have read and approved the final article. Drs. Needham, Chan, and Huang ity was demonstrated by significantly higher Functional Status
developed the study concept and design. Dr. Huang conducted statistical Score for the ICU scores among patients without ICU-acquired
analysis, and all authors interpreted the data. Drs. Huang, Chan, Parry, and weakness (Medical Research Council sum score, ≥ 48 vs
Needham drafted the article, and all authors have provided critical revisions
for important intellectual content. This study was supervised by Dr. Needham. < 48) and with hospital discharge to home (vs healthcare facil-
Supplemental digital content is available for this article. Direct URL citations ity). Functional Status Score for the ICU at ICU discharge
appear in the printed text and are provided in the HTML and PDF versions predicted post-ICU hospital length of stay and discharge loca-
of this article on the journal’s website (http://journals.lww.com/ccmjournal). tion. Responsiveness was supported via increased Functional
Supported, in part, by funding from the National Institutes of Health Status Score for the ICU scores with improvements in mus-
(R24HL111895).
cle strength. Distribution-based methods indicated a m inimal
Dr. Huang’s institution received funding from the National Institutes of Health
(NIH) (R24HL111895). Dr. Chan received support for this article research important difference of 2.0–5.0.
from the NIH. Her institution received funding from the NIH and Biogen. Conclusions: The Functional Status Score for the ICU has good
Dr. Kho received funding from the Canadian Institutes of Health Research internal consistency and is a valid and responsive measure of
and received support for this article research from the Canadian Institutes of
Health Research Fellowship and Bisby Prize. She currently holds a Canada physical function for ICU patients. The estimated minimal impor-
Research Chair in Critical Care Rehabilitation and Knowledge Translation. tant difference can be used in sample size calculations and in
Dr. Needham received support for this article research from the NIH. His interpreting studies comparing the physical function of groups of
institution received funding from the NIH. The remaining authors have dis-
closed that they do not have any potential conflicts of interest. ICU patients. (Crit Care Med 2016; 44:e1155–e1164)
For information regarding this article, E-mail: dale.needham@jhmi.edu Key Words: Australia; Brazil; cross-sectional studies; intensive
Copyright © 2016 by the Society of Critical Care Medicine and Wolters care; reproducibility of results; United States
Kluwer Health, Inc. All Rights Reserved.
DOI: 10.1097/CCM.0000000000001949
Critical Care Medicine www.ccmjournal.org e1155

Copyright © 2016 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.
Huang et al
C
ritically ill patients frequently experience long-last- hours in two mixed medical-surgical ICUs and received routine
ing impairments in physical functioning after dis- care in Melbourne, VIC, Australia, between 2012 and 2014 (13).
charge from the ICU (1–5). There is a growing body The Brazil-da Silva dataset (n = 99) included consecutive
of research aimed at evaluating ICU-based interventions that patients admitted in a single mixed (trauma, neurosurgical,
may reduce these impairments and growing interest in mea- and cardiovascular) ICU and received routine physical therapy
sures of physical function for critically ill adults (6–8). (no intervention) in at a public hospital in Brasilia, Brazil, in
The Functional Status Score for the ICU (FSS-ICU) is a 2014, using a Portuguese version of FSS-ICU developed with
physical function measure specifically designed for the ICU independent forward and backward language translation. The
that has not had comprehensive evaluation of its clinimetric FSS-ICU data were collected as part of the routine care of
performance (9, 10). The FSS-ICU includes five functional physical therapy evaluation.
tasks (rolling, transfer from spine to sit, sitting at the edge of The Brazil-Neto dataset (n = 561) included consecutive
bed, transfer from sit to stand, and walking). Each task is eval- patients more than or equal to 60 years old admitted in four
uated using an eight-point ordinal scale ranging from 0 (not ICUs (three medical-surgical and one surgical) and received
able to perform) to 7 (complete independence; Web Table 1, routine physical therapy (no intervention) at a private hospital
Supplemental Digital Content 1, http://links.lww.com/CCM/ in Brasilia, Brazil, between 2013 and 2014, using a Portuguese
B952; for example, scale, instrument, and scoring details are version of FSS-ICU translated by the Brazilian investigators.
available at http:www.ImproveLTO.com). The total FSS-ICU The FSS-ICU data were collected as part of the routine care of
score ranges from 0 to 35, with higher scores indicating better physical therapy evaluation.
physical functioning.
Our objective was to evaluate the internal consistency, con- Study Measures
struct and predictive validity, responsiveness, and minimum The FSS-ICU was evaluated prior to hospitalization (via proxy,
important difference (MID) of the FSS-ICU in ICU patients evaluating the 2-mo period prior to hospitalization) and at
across different in-patient assessment time points and across ICU awakening, ICU discharge, and hospital discharge for
international ICU settings. both U.S. studies; at ICU awakening, ICU discharge, and hos-
pital discharge for the Australian study; and at ICU admission
METHODS and ICU discharge for both Brazilian studies.
This analysis was conducted in accordance with the consen- Well-established measures of physical function, avail-
sus-based standards for the selection of health measurement able within the datasets, were used to assess convergent and
instruments guideline for evaluating the measurement proper- known-group validity of the FSS-ICU. These measures were
ties of instruments (11). the Lawton instrumental Activity of Daily Living (ADL) score
(17) (range, 0–8, with higher scores indicating better status),
Study Design the Katz ADL score (18) (range, 0–6, with higher scores indi-
We performed a clinimetric evaluation of the FSS-ICU using cating better status), manual muscle testing (MMT, using the
data from five international datasets: two from the United Medical Research Council sum score, range, 0–60, with higher
States (9, 12), one from Australia (13, 14), and two from Bra- scores indicating greater strength, and < 48 indicating ICU-
zil. All datasets were approved by the appropriate ethics review acquired weakness [ICUAW]) (19, 20), hand grip strength
boards, and where required, informed consent was obtained. (kg, as percent predicted using normative data [21, 22]), ICU
The USA-Kho dataset (n = 34) was a randomized pilot trial mobility scale (IMS; range, 0–10, with higher score indicating
of neuromuscular electrical stimulation (NMES) that enrolled better mobility) (23), ICU and hospital length of stay (LOS),
patients requiring mechanical ventilation for less than or equal and hospital discharge location (home vs healthcare facility).
to 4 days in three medical and surgical ICUs in an academic To assess discriminant validity, measures that were available
medical center in Baltimore, MD, between 2008 and 2013 (15, and expected to have little to no relationship with FSS-ICU
16). The randomized intervention of NMES versus a sham con- were used. These included body mass index (BMI), continence
trol group did not have a significant effect on the FSS-ICU score, status (from ADL scale), hemodialysis status, home oxygen use
so intervention and control groups were pooled for this analysis. at hospital discharge, steroid and insulin use on the hospital
The USA-Needham dataset (n = 59) was a quality improve- ward and at hospital discharge.
ment (QI) project that enrolled patients requiring mechanical We used two outcome measures to assess predictive validity of
ventilation for more than or equal to 4 days in a single medi- FSS-ICU, similar to prior research (13, 24–26): post-ICU hospital
cal ICU at an academic medical center in Baltimore, MD, dur- LOS (i.e., number of days between ICU and hospital discharge)
ing 2007 (9, 12). This project used a structured QI framework and hospital discharge location (home vs healthcare facility).
to improve functional mobility via physical and occupational To assess FSS-ICU’s responsiveness, changes in FSS-ICU
therapy. The QI versus pre-QI periods did not have a signifi- scores across two time points (ICU awakening/admission to
cant difference in the FSS-ICU score, so both periods were ICU discharge, ICU discharge to hospital discharge, and ICU
pooled for this analysis. awakening to hospital discharge) were evaluated and were
The Australia dataset (n = 66) included consecutive enrolled compared with changes across the same two time points for
patients requiring mechanical ventilation for more than 48 the MMT and ADLs.
e1156 www.ccmjournal.org December 2016 • Volume 44 • Number 12
Statistical Analysis Internal Consistency

Initially, analyses were conducted separately for each dataset Pearson correlations were used to identify pairwise correla-
and assessment time point to evaluate generalizability of these tions between the five FSS-ICU items, and Cronbach α was
individual findings by time point, patient sample, and study used to examine the internal consistency of the FSS-ICU total
setting, and then, pooled analyses across studies were per- score (27).
formed, whenever feasible and appropriate (i.e., when there
were similar results among individual datasets), to increase Concurrent Construct Validity
statistical power. All analyses were performed using Stata 13.1 We used Pearson correlations (for continuous measures) and
(Stata, College Station, TX). biserial correlations (for binary measures) to examine conver-
gent and discriminant validity. To evaluate convergent valid-
Floor and Ceiling Effects ity, we hypothesized that the measures evaluated would be
Floor and ceiling effects were evaluated by examining the per- at least moderately correlated (|r| > 0.40) with the FSS-ICU.
centage of assessments with the minimum and maximum FSS- To evaluate discriminant validity, we hypothesized that mea-
ICU scores, respectively. sures evaluated would have negligible to weak correlations
Table 1. Prehospitalization Patient Characteristics for Individual and Combined Studies

USA-Kho USA-Needham Australia Brazil-da Brazil-Neto Combined
Patient Characteristics (n = 34) (n = 59) (n = 66) Silva (n = 99) (n = 561)a (n ≤ 819)
Age (yr), mean (sd) 55 (16) 54 (15) 58 (17) 66 (10) 75 (9) 70 (13)
Men, n (%) 17 (50) 19 (32) 40 (61) 35 (35) 276 (49) 387 (47)
Body mass index (kg/m ), 2
27 (7) 29 (11) 28 (7) 28 (8)
mean (sd)
ADL score,b mean (sd) 6 (1) 5 (2) 5 (1)
Instrumental ADL score, c
6 (3) 4 (3) 5 (3)
mean (sd)
Functional Status Score 34 (4) 31 (9) 32 (8)
for the ICU,d mean (sd)
Acute Physiology and 25 (7) 26 (7) 21 (7) 14 (7) 12 (7) 14 (8)
Chronic Health
Evaluation II severity of
illness,e mean (sd)
ICU admission diagnosis,f
n (%)
Respiratory (including 25 (76) 39 (66) 14 (21) 30 (30) 108 (42)
pneumonia)
Gastrointestinal 3 (9) 5 (8) 12 (18) 8 (8) 28 (11)
Sepsis, nonpulmonary 0 (0) 3 (5) 13 (20) 18 (18) 34 (13)
Cardiovascular 2 (6) 4 (7) 18 (27) 10 (10) 34 (13)
Trauma 0 (0) 0 (0) 5 (8) 20 (20) 25 (10)
Neurologic 0 (0) 4 (7) 0 (0) 13 (13) 17 (7)
Other 3 (9) 4 (7) 4 (6) 0 (0) 11 (4)
Hospital length of stay, 35 (21) 31 (20) 28 (15) 19 (4) 33 (20)
mean (sd)
ADL = activities of daily living.
a
The Brazil-Neto study does not have ICU admission diagnosis data that fit into the above categories.
b
Activities of daily living (ADL) score has a range of 0–6 with higher score, indicating better functional status.
c
Instrumental ADL score has a range of 0–8 with higher score, indicating better functional status.
d
Functional Status Score for the ICU score has a range of 0–35 with higher score, indicating better functional status.
e
Acute Physiology And Chronic Health Evaluation II score has a range of 0–71, with higher score indicating greater severity of illness within first 24 hr of ICU
admission.
Percentages may not sum to 100 (%) because of rounding.
f

Huang et al
Table 2. Construct Validity: Cross-Sectional Relationship of Functional Status Score for

the ICU With Other Outcome Measures Across Publications and Assessment Time Points
Construct and Convergent Validity (Pearson Correlation)
Instrumental Manual Hand Hand Grip ICU

Time Point by Activities of Muscle Grip % Strength Mobility ICU Hospital
Publication n Daily Living ADL Testing Predicted (kg) Scaleb LOS LOS
Prehospitalization
USA-Kho 32 0.48d 0.73d –0.04
USA-Needham 46–50 0.57 d
0.80 d
Combined 78–82 0.55 d

0.80d
ICU awakening/admissione
USA-Kho 20–29 0.48d 0.81d 0.44d 0.41 0.46d
USA-Needham 43–52 0.72d
Australia 19–66 0.62d 0.30 0.30
Brazil-da Silva 99 0.38d
Brazil-Neto 561 0.32d
Combined 20–802 0.39d 0.44d 0.40d 0.37d 0.46d
ICU discharge
USA-Kho 12–27 0.70d 0.70d 0.43d 0.50d 0.62d 0.03
–0.18
Australia f
20–66 0.68 d
0.62 d
0.70 d
0.69 d
–0.24
Brazil-da Silva 99 0.95 d
–0.20d
Brazil-Neto 561 0.64d –0.27d
Combined 27–800 0.70d 0.60d 0.50d 0.59d 0.86d –0.25d
Hospital discharge
USA-Kho 12–28 0.86d 0.80d 0.46d 0.51d –0.17
0.80 d
–0.34d
Australia 8–19 0.39 0.51d 0.61d –0.46d
Combined 31–91 0.80d 0.80d 0.43d 0.49d –0.26d
ADL = activities of daily living, LOS = length of stay.
a
Biserial correlations evaluate a correlation when one variable is dichotomous and were used to evaluate correlation with continence, hemodialysis,
home oxygen, steroids, and insulin use.
b
This Hodgson ordinal ICU mobility scale evaluates patients’ highest mobility level, during physical therapy assessment in the ICU,
and ranges from 0 (lying in bed) to 10 (walking independently without a gait aid).
c
Represents any use of this medication on hospital ward (for the ICU discharge time point) and on hospital discharge (for hospital discharge time point).
d
p < 0.05.
e
ICU awakening was defined using the De Jonghe criteria in USA-Kho and Australia studies; in the USA-Needham study, it was defined based on
Richmond Agitation Sedation Scale and ability to follow instructions to perform the assessment.
A total of 20 patients had hand grip data, and 41 had ICU mobility scale data.
f
(|r| < 0.30). We hypothesized significant negative correlations Predictive Validity

between FSS-ICU and ICU and hospital LOS. For known- As done in prior research (13, 24, 25), we used two-sample
group validity, we conducted two-sample t tests for group dif- t tests and linear and logistic regression models to test the
ferences in FSS-ICU by ICUAW status (MMT ≥ 48 vs < 48) association of FSS-ICU at ICU discharge with post-ICU hos-
and hospital discharge location (home vs healthcare facility). pital LOS and hospital discharge location. In addition, the area
We hypothesized that patients without (vs with) ICUAW or under a receiver operating characteristic curve (i.e., C statis-
discharged to home (vs healthcare facility) would have signifi- tic) was calculated for FSS-ICU with discharge location. We
cantly higher FSS-ICU scores. hypothesized that patients with higher FSS-ICU scores at ICU
Discriminant Validity (Biserial Correlationa)
Body Mass Index Continence Item Hemodialysis Need for Home

(kg/m2) From ADL Status Oxygen Steroid Usec Insulin Usec
0.09
< 0.01 0.01
–0.03 0.03
–0.01 0.50d
0.16
–0.17
–0.01 0.50d
0.05 0.70d 0.06 –0.20 0.33

0.31 d
–0.26 0.30 0.05
–0.21
0.05 0.70d –0.20 0.19 0.11
d
0.12 0.78d 0.30 –0.12 –0.15 0.33
0.11 0.29 0.14 0.22 –0.12 –0.24
–0.37
–0.05 0.42d 0.38d 0.05 –0.16 –0.06
discharge would have a shorter post-ICU hospital LOS and be the effect size for changes over time (mean difference in FSS-
discharged to home (vs healthcare facility). ICU scores between two time points divided by the sd at first
time point) (28). Third, we evaluated change over time in
Responsiveness the FSS-ICU relative to patients’ change in MMT and ADL
Responsiveness was examined in three ways. First, we tracked scores, with changes categorized as “significant improve-
FSS-ICU scores across the expected recovery trajectory. Dif- ment” if MMT and ADL scores at the later assessment were
ferences in mean FSS-ICU scores between consecutive time greater than or equal to 1sd higher than the earlier assess-
points were tested using paired t tests. Second, we calculated ments. A comparison group was comprised of patients

Huang et al
whose scores increased less than 1sd or declined over the to 0.95 (USA-Needham), 0.91 to 0.93 (Australia), 0.78 to 0.91
period (29). (Brazil-da Silva), and 0.78 to 0.93 (Brazil-Neto).
Estimating MID Concurrent Construct Validity

We used the following distribution-based methods to estimate Consistently, across studies and time points (Table 2), we
MID (30, 31): sem, minimal detectable change 90 (MDC-90), observed significant and positive correlations between FSS-
0.2sd, and 0.5sd (32). ICU and other physical measures and negative association with
ICU and hospital LOS. These findings support concurrent
validity. Known-group validity was supported by significantly
RESULTS
higher FSS-ICU scores among survivors without ICUAW
Patient Characteristics (MMT ≥ 48 vs < 48) and among those discharged to home (vs
Across the five studies, the mean (sd) age of patients ranged healthcare facility) (Web Table 2, Supplemental Digital Con-
from 54 (15) to 75 (9) years, and the mean (sd) Acute Physi- tent 2, http://links.lww.com/CCM/B953).
ology And Chronic Health Evaluation (APACHE) II score Consistent with our hypotheses, most associations were not
ranged from 12 (7) to 26 (7) (Table 1). Both Brazilian studies statistically significant between FSS-ICU and BMI, hemodialy-
had older patients and lower APACHE II scores. There was sis, need for home oxygen, and steroid and insulin use. These
a wide range of ICU admission diagnoses across the stud- findings support discriminant validity (Table 2).
ies, with respiratory failure being the most common primary
diagnosis (42% in the combined dataset). Predictive Validity
We found evidence of predictive validity for duration of
Floor and Ceiling Effect post-ICU hospital LOS in the USA-Needham study and in
Minimal floor effect was observed (0.5%, 0.3%, and 0% combined results across all studies, with significantly higher
at ICU admission/awakening, ICU discharge, and hospital FSS-ICU scores at ICU discharge for survivors with below
discharge, respectively). Some ceiling effect was observed versus above the median post-ICU hospital LOS (Table 3).
later during recovery (0.7% at ICU admission/awaken- Linear regression analysis suggested that for a 1-unit increase
ing and then 11% and 21% at ICU and hospital discharge, in FSS-ICU score, post-ICU hospital LOS decreased by 0.27
respectively). days (p < 0.01) in the combined results (Table 3). Predic-
tion of discharge location was consistently significant across
Internal Consistency studies: survivors discharged to home were associated with
Good to excellent internal consistency was observed (33). The a higher FSS-ICU at ICU discharge (23 vs 16 in combined
correlation coefficients for pairwise correlation between FSS- results; p < 0.01). Logistic regression indicated that for
ICU items were all positive and significant (p < 0.05) in all 1-unit increase in FSS-ICU score, the odds of discharge to
datasets and at all time points. Across time points, Cronbach home increased by 11% (p < 0.01) in combined results. The
α for each study ranged from 0.90 to 0.94 (USA-Kho), 0.94 C-statistic for discharge location was 0.75 in the combined
Predictive Validity of Functional Status Score for the ICU at ICU Discharge for
Table 3.
Duration of Post-ICU Hospital Stay and Discharge Location
Mean Functional Status
Score for the ICU Score, Discharge Location
Below vs Above Median Post-ICU Hospital Discharge (Home vs Healthcare Area Under
Post-ICU Hospital LOS LOS (Continuous) Location Facility) the Receiver
Operating
Linear Characteristics
Time Point by Below Above Regression Healthcare Odds Ratio Curve
Publicationa Medianb Medianb pc
Coefficient p Home Facilityd pc (95% CI) p (i.e., C-Statistic)
ICU discharge
USA-Kho 23 19 0.19 –0.23 0.19 25 16 < 0.01 1.23 (1.05–1.45) 0.01 0.83
USA-Needham 22 13 < 0.01 –0.37 < 0.01 23 15 < 0.01 1.11 (1.02–1.20) 0.01 0.73
Australia 20 18 0.23 –0.24 0.08 22 16 < 0.01 1.09 (1.02–1.17) < 0.01 0.72
Combined 21 17 < 0.01 –0.27 < 0.01 23 16 < 0.01 1.11 (1.06–1.17) < 0.01 0.75
LOS = length of stay.
Sample size by post-ICU hospital length of stay (LOS) (below median and above median): USA-Kho (12, 14), USA-Needham (21, 23), and Australia (32, 34).
a
Sample size by discharge location (home and healthcare facility): USA-Kho (13, 15), USA-Needham (15, 29), and Australia (26, 37).
b
Median LOS (d) in different publications: USA-Kho: 10; USA-Needham: 10; Australia: 14; and combined: 11.
c
p values calculated using two-sample t test.
d
Healthcare facilities include nursing home, other hospital’s ICU or ward, or long-term ventilation facility.
analysis, indicating that FSS-ICU can adequately predict dis- Although not always statistically significant, increased
charge location. FSS-ICU scores were generally observed with improvements
in muscle strength (Table 4), supporting responsiveness. The
Responsiveness effect size was 2.02 from ICU awakening/admission to ICU
Mean FSS-ICU scores at each time point are shown in Web Fig- discharge, suggesting good responsiveness. Only the USA-Kho
ure 1 (Supplemental Digital Content 3, http://links.lww.com/ study, with data on 24–26 patients, could be used to evaluate
CCM/B954; legend, Supplemental Digital Content 4, http:// the FSS-ICU’s responsiveness to changes in ADL scores. This
links.lww.com/CCM/B955). Consistent with the expected study showed a larger increase in FSS-ICU among survivors
functional trajectory, the FSS-ICU score decreased from the with more than 1-sd increase in ADL scores compared with
baseline value prior to hospitalization to ICU admission/ those with negative or no change in ADL scores although this
awakening and then increased at ICU and hospital discharge. difference was significant only when comparing ICU discharge
Changes between each consecutive time point were statistically with hospital discharge (Table 4).
significant (p < 0.01). In combined analysis, the median (inter-
quartile range) FSS-ICU score was 35 (33–35) prior to hospi- MID
talization, 5 (5–10) at ICU admission/awakening, 20 (10–30) at In the combined results, MID estimates based on the sem and
ICU discharge, and 29 (20–34) at hospital discharge. 0.2sd were relatively consistent with 1.2–1.3 for ICU admission/
Table 4. Responsiveness to Change of Functional Status Score for the ICU Score Versus
Manual Muscle Testing and Activity of Daily Living Scores
Change in FSS-ICU Change in FSS-ICU
MMT Score, MMT Score, ADL Score, ADL Score, Effect

Negative or Significant Negative or Significant Size for
Time Point by Publication a
No Changeb Positive Changeb No Changeb Positive Changeb FSS-ICU
ICU awakening/admission to ICU discharge

USA-Kho 5.8 9.8 7.1 7.5 0.84
USA-Needham 5.8 c
12.0 c
0.99
Australia 3.9 c
11.9 c
0.84
Brazil-Neto d
13.5 c
16.5 c
2.62
Combined 10.0 c
17.5 c
7.1 7.5 2.02
ICU discharge to hospital discharge
USA-Kho 8.1 16.3 5.2c 13.8c 0.93
USA-Needham 5.3 8.5 0.69
Australia 13.0 7.0e 1.45
Combined 7.1 11.6 5.2c 13.8c 0.92
ICU awakening to hospital discharge
USA-Kho 10.5c 17.8c 10.7 15.9 1.71
USA-Needham 8.4 c
15.3 c
1.78
Australia 21.4 19.7 2.51
Combined 11.1 c
15.6 c
10.7 15.9 1.85
ADL = activities of daily living, FSS-ICU = Functional Status Score for the ICU, MMT = manual muscle testing.
a
Sample sizes for difference in Functional Status Score for the ICU (FSS-ICU) values by time point and outcome measure: 1) manual muscle testing (MMT) (no
change and positive change): ICU awakening to ICU discharge: USA-Kho (8, 13), USA-Needham (7, 30), Australia (23, 43), and Brazil-Neto (465, 73); ICU
discharge to hospital discharge: USA-Kho (3, 22), USA-Needham (6, 31), and Australia (1, 8); and ICU awakening to hospital discharge: USA-Kho (12, 15),
USA-Needham (15, 22), and Australia (3, 6). 2) Activities of daily living (ADL) (no change and positive change): ICU awakening to ICU discharge: USA-Kho
(2, 22); and ICU discharge to hospital discharge: USA-Kho (11, 15).
b
The “no change” category represents all patients who did not increase by more than 1 sd at last available FSS-ICU time points; except for Brazil-Neto study,
no patient had a decrease in MMT or ADL scores of more than 1 sd. The sd used for different studies: MMT: USA-Kho (7), USA-Needham (10), Australia (6),
Brazil-Neto (14), Combined (8); ADL: USA-Kho (3).
c
p < 0.05 by two-sample t test for comparison of “negative or no change” versus “significant positive change” categories.
d
In Brazil-Neto study, there were patients with significant decrease (> 1sd) of MMT score from ICU admission to ICU discharge, and the change in FSS-ICU in
MMT score significant negative change group was 2.9 (n = 22). This is significantly different from the change in FSS-ICU in MMT score no change or positive
change groups.
e
Only one patient was found in this group.

Huang et al
awakening, 2.1–2.4 for ICU discharge, and 1.7–1.9 for hospital of survivors from ICU awakening/admission to hospital dis-
discharge (Table 5). Estimates based on MDC-90 and 0.50sd charge with a large effect size, supporting responsiveness. The
also were consistent but larger at 3.0–3.1, 5.3–5.4, and 4.3–4.5 MID for the FSS-ICU, based on multiple distribution-based
for the same time points, respectively. Hence, the MID is esti- methods, is estimated within a range of 2.0–5.0. These results
mated to be in the range of 2.0–5.0. were similar across various time points and the 5 datasets, sup-
porting generalizability.
DISCUSSION The results of this evaluation should be compared with sim-
Using data from five studies across three continents, we evalu- ilar evaluations of other published ICU-specific physical func-
ated internal consistency, validity, responsiveness, and MID of tion measures, including the Physical Function in Intensive
FSS-ICU, an outcome measure assessing physical function in care Test scored (PFIT-s) (13, 24, 37), Chelsea Critical Care
critically ill patients (7, 10, 13). We found consistent and strong Physical Assessment tool (CPAx) (38–40), Perme mobility
evidence of internal consistency and concurrent construct scale (41, 42), Acute Care Index of Function (ACIF) score (43),
validity with expected findings for convergent, discriminant, Surgical ICU Optimal Mobilization Score (SOMS) (25, 26,
and known-group validity tests. The similarity of these clini- 44), and the IMS (23). With respect to floor and ceiling effects,
metric analyses across individual studies demonstrates gener- for the FSS-ICU, we detected a minimal floor effect (≤ 0.5%),
alizability of results and supports pooling of data and analyses but some ceiling effects at hospital discharge (≤ 21%), which
across studies, as done in prior research (34–36). may limit the instrument’s ability to detect improvement (45).
The findings of convergent validity between the FSS-ICU However, these findings are favorably comparable with other
and MMT agree with a prior smaller analysis (13). Prior studies ICU-specific physical measures (Web Table 3, Supplemental
of the FSS-ICU also provided preliminary evidence of predic- Digital Content 5, http://links.lww.com/CCM/B956). The
tive validity and responsiveness (10, 13), which were expanded CPAx has the lowest ceiling effects at ICU discharge (39, 40);
in our current analyses with larger sample size and more vari- however, it is important to note that CPAx differs from other
ables. Predictive validity was supported with FSS-ICU scores ICU-specific measures (Web Table 3, Supplemental Digital
at ICU discharge significantly predicting post-ICU hospital Content 5, http://links.lww.com/CCM/B956) as it involves
LOS and hospital discharge location. An increase in FSS-ICU evaluation of both physical function (whole body activities
score was observed with improvement in muscle strength and and grip strength) and respiratory (ventilation, oxygenation,
ADLs, and FSS-ICU scores tracked the recovery trajectory and secretion clearance) measures.
Table 5.Minimum Important Difference for Functional Status Score for the ICU:
Distribution-Based Estimates
USA-Kho USA-Needham Australia Brazil-da Silva Brazil-Neto Combined
Study (Sample Size) (n = 27–29) (n = 44–52) (n = 19–66)a (n = 99) (n = 561) (n = 91–807)
sem
ICU awakening/admission 1.8 1.7 1.8 1.0 1.1 1.3 (807)

ICU discharge 1.9 2.1 2.0 2.0 2.4 2.4 (800)
Hospital discharge 1.6 2.1 0.9 1.9 (91)
Minimal detectable change90
ICU discharge 4.3 4.9 4.7 4.8 5.7 5.4 (800)
0.5sd (moderate Cohen effect size)
ICU discharge 4.2 4.7 4.6 4.6 5.4 5.3 (800)
0.2sd (small Cohen effect size)
ICU discharge 1.7 1.9 1.8 1.8 2.2 2.1 (800)
Only 19 patients at hospital discharge.
a
For evaluation of validity, the PFIT-s, IMS, and CPAx also with those from 0.2sd (31, 46). Future studies should compare
displayed concurrent construct validity with MMT (Web anchor-based MIDs with distribution-based MIDs.
Table 3, Supplemental Digital Content 5, http://links.lww.
com/CCM/B956). Similar to FSS-ICU, PFIT-s also showed
CONCLUSIONS
construct validity with hand grip strength and IMS, and there
The FSS-ICU is an internally consistent, valid, and responsive
is a strong positive correlation between FSS-ICU and PFIT-s
measure of physical function in the ICU and acute hospital
(ρ = 0.85–0.87; p < 0.005) at ICU awakening and ICU dis-
ward setting. The estimated range for the MID of 2.0–5.0 will
charge (13). Our analyses also demonstrated appropriate
facilitate sample size calculations and interpretation of future
divergent validity of FSS-ICU.
group comparison studies in ICU patients.
For predictive validity, a higher FSS-ICU, along with higher
PFIT-s, IMS, SOMS, and ACIF scores, predict shorter hospital
LOS and/or discharge location to home. The PFIT-s, IMS, and ACKNOWLEDGMENT
CPAx also demonstrated moderate to large responsiveness to We thank all of the patients who participated in this study.
change via effect-size analyses. Although a prior study of the
FSS-ICU demonstrated small responsiveness to change (effect
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FSS Icu

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FSS Icu

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Online Clinical Investigations

Functional Status Score for the ICU: An

Critical Care Medicine www.ccmjournal.org e1155

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Statistical Analysis Internal Consistency

Table 1. Prehospitalization Patient Characteristics for Individual and Combined Studies

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Table 2. Construct Validity: Cross-Sectional Relationship of Functional Status Score for

Instrumental Manual Hand Hand Grip ICU

Combined 78–82 0.55 d

(|r| < 0.30). We hypothesized significant negative correlations Predictive Validity

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Discriminant Validity (Biserial Correlationa)

Body Mass Index Continence Item Hemodialysis Need for Home

0.05 0.70d 0.06 –0.20 0.33

0.05 0.70d –0.20 0.19 0.11

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Estimating MID Concurrent Construct Validity

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MMT Score, MMT Score, ADL Score, ADL Score, Effect

ICU awakening/admission to ICU discharge

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ICU awakening/admission 1.8 1.7 1.8 1.0 1.1 1.3 (807)

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