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Table 4 Criterion-concurrent validity, criterion-predictive validity and construct validity of outcome measures

From: Functional capacity, physical activity and muscle strength assessment of individuals with non-small cell lung cancer: a systematic review of instruments and their measurement properties

Author, yr

Type of validity and OM

Missing values

Comparator OM or predicted outcome

Validation results

Functional capacity

    

Jones 2012 [40]

Crit-pred 6MWT

Nil

All-cause mortality

Unadjusted HR p = 0.003; Compared to 6MWT <358.5 m adjusted HR = 0.61 (95% CI 0.34-1.07) if 6MWT 358.5-450 m; Compared to 6MWT <385.5 m adjusted HR = 0.48 (95% CI 0.24-0.93) if 6MWT >450 m

Pancieri 2010 [22]

Crit-pred 6MWT

NR

Predicted post-op 6MWT = pre-op 6MWT x (FS – resected FS) ÷ FS

r = 0.40, p<0.01

Kasymjanova 2009 [25]

Crit-pred 6MWT

19pts dropped out

Survival

Compared to 6MWT ≥ 400 m mortality HR = 0.44 (95% CI 0.23-0.83) if 6MWT <400 m, p = 0.001

Mao 2007* Miller 2005 [26, 27]

Crit-pred; construct 6MWT

3pts not complete Ax

1. Development of RP

1. ROC area under curve = 0.41, p = 0.4

2. FEV1

2. r = 0.53, p<0.001

3. FVC

3. r = 0.44, p = 0.001

4. DLCO

4. r = 0.48, p<0.001

Saad 2007 [24]

Crit-pred 6MWT

9pts died; 30pts not complete Ax (rural)

Predictors of improvement in pre-op to 180 days-post-op:

1. GEE = 0.001, SE = 0.000, p = 0.003

1. SF-36 PF

2. GEE = 0.001, SE = 0.000, p = 0.000

2. SF-36 PR

3. GEE = 0.001, SE = 0.000, p = 0.031

3. SF-36 GH

 

Parsons 2003 [39]

Crit-pred 6MWT

29pts

LOS out of hospital < 30 days post-op

Not significant

Pierce 1994 [23]

Crit-pred 6MWT

NR

Post-op:

1. p<0.05

1. respiratory failure

2. p>0.05

2. surgical POC

3. p>0.05

3. respiratory POC

4. p>0.05

4. cardiac POC

5. p>0.05

5. all POC

Holden 1992 [41]

Crit-pred 6MWT

3pts not complete Ax

Survival > 90 days post-op

6MWT diff b/t groups with/without survival p<0.05;

6MWT > 1000feet (305 m) pre-op sensitivity 100%, positive predictive value 85%, negative predictive value 100% for survival

England 2012 [44]

Construct ISWT

Nil

1. P max monitor (insp mm strength)

1. r = 0.42, p = 0.01

2. dynamometry (peripheral mm power)

2. r = 0.39, p = 0.01

3. spirometry (% predicted FEV1)

3. r = 0.22, p = 0.17

4. spirometry (% predicted FVC)

4. r = 0.21, p = 0.2

5. CRDQ (mastery)

5. r = 0.21, p = 0.18

Win 2006 [30]

Crit-pred; crit-concurrent; construct ISWT

Nil

1. CPET (VO2peak)

1. r = 0.67, p<0.001

2. CPET (VO2peak% predicted)

2. r = 0.30

3. spirometry (FEV1)

3. r = 0.5

4. 12 month survival

4. ROC area = 0.7, p = 0.003

Win 2004 [64]

Crit-pred, construct ISWT

8pts

1. poor surgical outcome (post-op death, MI, heart failure, resp failure, septicaemia, pneumonia, cardiac arrthymia)

1. p = 0.6 between poor and sufficient outcome groups

2. FEV1

2. r = 0.46, not significant

Brunelli 2012 [43]

Crit-pred SCT

14

Median survival and 5-year survival

Altitude >18 m independent predictor: HR = 0.5, p = 0.003

Brunelli 2010 [31]

Construct SCT

Nil

SCT (VO2max)

Altitude: correlation coefficient = 0.7, p<0.0001

Speed of ascent: correlation coefficient = 0.47, p = 0.005

Pancieri 2010 [22]

Crit-pred SCT

NR

Predicted post-op SCT = pre-op SCT x (FS – resected FS) ÷ FS

r = 0.66, p<0.001

Brunelli 2008a [34]

Crit-pred SCT

Nil

POC < 30 days post-op

Pre-op altitude: coefficient = −0.05, OR = 0.95 (95% CI 0.91-0.99), SE = 0.02, p = 0.045

O2desat >4%: coefficient = 0.56, OR = 1.8 (95% CI 1–3), SE = 0.3, p = 0.05

Brunelli 2008b [33]

Crit-pred SCT

Nil

1. POC < 30 days post-op

1. altitude: coefficient = 0.34, SE = 0.2, OR = 1.4 (95% CI 1.02-1.95), p = 0.04

2. Death < 30 days post-op

2. altitude: coefficient = 0.91, SE = 0.4, OR = 2.5 (95% CI 1.1-5.5), p = 0.02

3. Post-op hospital costs

3. altitude: coefficient = 2160.2, SE = 573, p<0.001

Koegelenberg 2008 [29]

Crit-concurrent SCT

Nil

CPET (VO2max)

Altitude r2 = 0.06, Speed of ascent r2 = 0.77 (lung cancer only)

Nikolic 2008 [36]

Crit-pred SCT

Nil

POC < 30 days post-op

Best independent predictor = SpO2 after 40 steps and SCT duration for lobectomy group (60% sensitivity, 75% specificity cut off value 1.09) positive LR = 2.4 (95% CI 1.71-3.38), negative LR = 0.53 (95% CI 0.38-0.76)

Brunelli 2007 [20]

Constuct SCT

53pts at 3 months

Post-op SCT (VO2peak)

Pre-op SCT VO2peak directly associated with post-op SCT: regression analysis lobectomy F = 3.58, p<0.01; pneumonectomy F = 3.53, p<0.01

Toker 2007 [37]

Crit-pred SCT

Nil

POC (cardiac or pulmonary)

SpO2 pre-SCT: OR = 0.74 (95% CI 0.58-1.00), p = 0.001

Change SpO2 pre to post-SCT: OR = 1.59 (95% CI 1.21-2.10), p = 0.018

Brunelli 2005 [42]

Crit-pred SCT

13pts

1. POC < 30 days post-op

Inability to perform pre-op SCT:

1. p = 0.7

2. Death < 30 days post-op

2. OR = 0.20 (95% CI 0.06-0.62), p = 0.005

Brunelli 2004 [35]

Crit-pred SCT

18pts

POC < 30 days post-op

Lower altitude pre-op independent predictor: coefficient = −0.18, p = 0.0015

Brunelli 2003 [21]

Crit-pred SCT

Nil

O2 desat during post-op SCT

O2 desat during pre-op SCT independent variable: regression coefficient = 0.22, p = 0.0004

Parsons 2003 [39]

Crit-pred SCT

29pts

LOS out of hospital < 30 days post-op

1. longer LOS correlated with speed of ascent r = 0.34, p≤0.02

2. workload achieved predicted LOS out of hospital r2 = 0.130

Brunelli 2002 [32]

Crit-pred SCT

Nil

POC < 30 days post-op

Altitude independent variable: p = 0.003

Pate 1996 [38]

Crit-pred SCT

Nil

POC < 30 days post-op

Significant difference in pre-op SCT between pt who did and did not develop POC

Holden 1982 [41]

Crit-pred SCT

3pts

Survival > 90 days post-op

SCT diff b/t groups with/without survival p<0.05

SCT > 44steps pre-op positive predictive value 91%, negative predictive value 80% for survival

Physical activity

    

Maddocks 2012 [47]

Construct Acc

Nil

ECOG PS

Statistically significant difference in mean daily step count, time spent sitting/lying, upright, standing or stepping between PS 0, 1 and 2 p<0.05 but not mean daily sit-to-stand transitions

Grutsch 2011a, 2011b; Du-Quiton 2010 [48–50]

Construct Acc

16pts Acc, 16pts questionnaires

1. HADS

1. Outpt: depression and activity r = −0.41, p = 0.04

2. Ferrans and Power QLI Cancer Version III

2. Daytime activity and QLI domains of health/functioning r = 0.51, p<0.01; social/economic r = 0.38, p = 0.048; psychological/spiritual r = 0.45, p = 0.02; family r = 0.45, p = 0.02; overall QLI r = 0.57, p<0.01

3. EORTC

3. Inpt: daytime activity and loss of appetite r = −0.41, p = 0.005

4. PSQI

4. Outpt: lower sleep medication use and activity r = −0.58, p<0.01

Novoa 2011 [51]

Construct Pedom

13 pts – unable to perform exercise test

CPET (VO2max)

Mean daily total steps r = 0.4

Mean daily aerobic steps r = 0.16

Mean daily time of aerobic capacity r = 0.11

Mean daily distance walked r = 0.44

Maddocks 2010 [46]

Construct Acc

2 pts withdrawn

Estimated EE (stepping and non-stepping) measured from acc

Non-stepping EE and daily step count r = −0.91, p<0.01

Muscle strength

    

Brown 2005 [53]

Construct CST

Nil

1. KPS

1. r2 = 0.565, p < 0.001 (ca group)

   

2. FACIT-fatigue

2. with incr fatigue, lower CST p<0.01 (ca group)

  1. Abbreviations: 6MWT, six minute walk test; 95% CI, 95% confidence intervals; acc, accelerometery; Ax, assessment; b/t, between; ca, cancer; CPET, cardio-pulmonary exercise testing; CRDQ, Chronic Respiratory Disease Questionnaire; crit, criterion; CST, chair-stand test; desat, desaturation; diff, difference; DLCO, diffused capacity for carbon monoxide; ECOG, Eastern Cooperative Oncology Group; EE, energy expenditure; EORTC, European Organisation for Research and Treatment of Cancer quality of life questionnaire; FACIT-fatigue, Functional Assessment of Chronic Illness Therapy- Fatigue scale; FEV 1 , force expired volume in one second; FS, lung functioning segments; FVC, forced vital capacity; GEE, generalized estimation equations; HADS, Hospital Anxiety and Depression Scale; HR, hazard ratio; insp, inspiratory; inpt, inpatient; ISWT, incremental-shuttle walk test; KPS, Karnofsky performance status; LOS, length of stay; LR, likelihood ratio; m, meters; max, maximum; MI, myocardial infarction; mm, muscle; NR, not reported; OM, outcome measure; OR, odds ratio; outpt, outpatient; P, pressure; pedom, pedometer; POC, post-operative complication; post-op, post-operative; pre-op, pre-operative; pred, predictive; PS, performance status; pt, participant; PSQI, Pittsburgh Sleep Quality Index; QLI, Quality of Life Index; r, correlation coefficient; ROC, received operating characteristic curve; SCT, stair-climb test; SE, standard error; SF-36, Short Form 36 physical functioning/physical role/general health domain; resp, respiratory; RP, radiation pneumonitis; Rx, treatment; SpO 2 , oxygen saturation; VO 2max , maximum oxygen consumption; VO 2peak , peak oxygen consumption; yr, year published.
  2. * results presented from most recent publication.