The PROactive instruments to measure physical …erj.ersjournals.com/content/erj/suppl/2015/05/28/09031936.00183014...The PROactive instruments to measure physical activity in

Online Data Supplement 1

ONLINE SUPPLEMENTARY MATERIAL

The PROactive instruments to measure physical activity in

patients with COPD

Elena Gimeno-Santos, Yogini Raste, Heleen Demeyer, Zafeiris Louvaris,

Corina de Jong, Roberto A Rabinovich, Nicholas S Hopkinson, Michael I

Polkey, Ioannis Vogiatzis, Maggie Tabberer, Fabienne Dobbels, Nathalie

Ivanoff, Willem I de Boer, Thys van der Molen, Karoly Kulich, Ignasi Serra,

Xavier Basagaña, Thierry Troosters, Milo A Puhan, Niklas Karlsson, Judith

Garcia-Aymerich on behalf of PROactive consortium

Methods – complete version ............................................................................... 4

List of proposed items for day-to-day (Daily) assessment ................................ 19

List of proposed items for Clinic visit assessment ............................................ 22

Table E1. Baseline demographic and clinical characteristics of COPD patients

stratified by sites ............................................................................................... 25

Table E2. Description of activity monitor data, stratified by visit and by site ..... 29

Table E3. Performance of all items from Daily version of PROactive Physical

Activity in COPD (D-PPAC) instrument and Dynaport prior to item reduction .. 31

Table E4. Performance of all items from Clinical visit version of PROactive

Physical Activity in COPD (C-PPAC) instrument and Dynaport prior to item

reduction........................................................................................................... 32


Table E5. Reason for removing items that flagged in at least one predefined

criteria .............................................................................................................. 33

Table E6. Confirmatory factor analysis results of Daily and Clinical visit versions

of PROactive Physical Activity in COPD instruments (D-PPAC and C-PPAC,

respectively) ..................................................................................................... 52

Table E7. Performance of items from factor 1 (‘amount’) without variables from

the activity monitors ............................................. Error! Bookmark not defined.

Table E8. Scores for Daily and Clinical visit versions of PROactive Physical

Activity in COPD instruments (D-PPAC and C-PPAC, respectively), stratified by

gender and severity .......................................................................................... 55

Table E9. Daily and Clinical visit versions of PROactive Physical Activity in

COPD scores (D-PPAC and C-PPAC, respectively) according to dyspnea

groups, exacerbation status at baseline, and physical activity levels (known-

groups validity) ................................................................................................. 56

Table E10. Correlation of Daily and Clinical visit versions of PROactive Physical

Activity in COPD instruments (D-PPAC and C-PPAC, respectively) with height,

socioeconomic status and heart rate (discriminant validity) ............................. 58

Figure E1. Person-item maps and overall fit of the model for factor 1 (‘amount’)

of Daily and Clinical visit PROactive PROs (without variables from activity

monitors) ............................................................. Error! Bookmark not defined.

Figure E2. Bland-Altman test-retest reliability of Daily PROactive Physical

Activity in COPD (D-PPAC) instrument – daily values ...................................... 61

Figure E3. Bland-Altman test-retest reliability of Clinical visit version of

PROactive Physical Pctivity in COPD (C-PPAC) instrument ............................ 66


Final version of the Daily of PROactive Physical Activity in COPD (D-PPAC)

instrument......................................................................................................... 67

Final version of the Clinical visit of PROactive Physical Activity in COPD (C-

PPAC) instrument ............................................................................................. 69

References ....................................................................................................... 72


Methods – complete version

Study Design, Sample, and Procedures

The current study was a six-week, randomized, two-way cross-over, multi-centre

study (Figure 1). Study was conducted in five European medical centers, covering

tertiary hospitals, rehabilitation centers and primary care settings in Athens (Greece),

Edinburgh and London (UK), Leuven (Belgium), and Groningen (The Netherlands).

We recruited both stable and exacerbated patients with COPD defined by spirometry,

to cover the whole range of physical activity.

Inclusion criteria were as follows: (i) men or women at least 40 years of age, (ii) with

medical diagnosis of COPD (post bronchodilator FEV1 less than 80% and FEV1/FVC

less than 70%) confirmed by spirometry, (iii) smoking history equivalent to at least 10

pack years, (iv) able to read and write and to use electronic devices and physical

activity monitors, and (v) for the patients into stable group, COPD was defined stable

if the patient had not used systemic antibiotics nor systemic corticosteroids nor had

been hospitalized due to COPD in the previous 4 weeks; for the patients into

exacerbated group, COPD exacerbation was defined as admitted into emergency

room or hospitalized under the care of a pneumologist (irrespective of the ward).

Exclusion criteria were: (i) orthopaedic, neurological or other complaints that

significantly impair normal biomechanical movement patterns, (ii) respiratory

diseases other than COPD (e.g. asthma), (iii) COPD exacerbation within 4 weeks

prior to Visit 1 (only applicable for patients in the stable group), (iv) cognitive

impairment, (v) involvement in the planning and/or conduct of the study, and (vi)

previous randomization in the present study.


Patients that fulfilled the inclusion criteria were randomized into one of the two arms

using statistical software in varying blocks of 4, 6 or 8, and separately by site and by

status (stable/exacerbated). In arm 1 (Figure 1), patients followed a sequence of a

baseline assessment (visit 1), a 14 days period during which they completed the

Daily PROactive item pool and wore the physical activity monitor devices, followed by

a second visit (visit 2) where they returned the electronic devices. After a 14-day

wash-out period, patients underwent a third visit (visit 3) in which they completed the

Clinical visit PROactive item pool, prior to start a new 14 days period during which

they wore the physical activity monitors, and then came back for visit 4, when they

again completed the Clinical visit PROactive item pool and returned the physical

activity monitors. Patients in arm 2 followed the sequence in reverse order (Figure 1).

The study was performed in accordance with ethical principles that have their origin

in the Declaration of Helsinki and are consistent with Good Clinical Practice and

applicable regulatory requirements. The study was advised and approved by the

PROactive ethics and patient advisory boards and approved by the Ethics Committee

at each center. Written consent was obtained from all patients. The study was

registered at www.clinicaltrials.gov (NCT01388218).

The PROactive project (www.proactivecopd.com) was funded through the Innovative

Medicines Initiative (IMI) supported by the European Commission and the European

Federation of Pharmaceutical Industry and Associations.

Assessments and measures

Figure 1 shows the assessments and timing for the study.

Physical activity measures. Physical activity experience was assessed using the

PROactive item pools that were self-administrated using a LogPad® (PHT


Corporation, Geneva, Switzerland) handheld electronic patient-reported outcome

(PRO) device (ePRO). All the items for the PROactive PROs were previously

developed according to current European Medicines Agency (EMA) (E1) and US

Food and Drug Administration (FDA) standards (E2) in order to support claims for the

use of pharmacotherapy related to changes in domains of physical activity relevant to

patients. Their development published elsewhere (E3) was based on input from the

literature, from experts, and from patients through qualitative research using one-to-

one interviews, focus groups and cognitive debriefing interviews to measure physical

activity from the patients’ perspective on a daily basis (Daily PROactive PRO), and

during clinic visits (Clinical visit PROactive PRO). All items were linguistically adapted

or each site (E3). The Daily PROactive PRO asked patients to report their physical

activity experiences during a day. It consisted of 30 questions, where the majority of

questions were responded to on a five- or six- point Likert scale. A few questions

were dichotomous with “yes” or “no” response. It was to be completed by the patient

every evening at home between visit 1 and visit 2 for patients in arm 1, and between

visit 3 and visit 4 for patients in arm 2. The Clinical visit PROactive PRO asked

patients to report their physical activity experiences in the past 7 days. It consisted of

35 questions, where all except two dichotomous questions were responded to on a

five- or six- point Likert scale. It was to be completed by the patient at visit 1 and visit

2 for patients in arm 2, and at visit 3 and visit 4 for patients in arm 1.

Moreover, two accelerometers previously identified during a systematic review [E4]

and further validated for COPD patients against the doubly labelled water (DLW)

method [E5] and the indirect calirometry [E6] (Actigraph G3Tx, Actigraph, Pensacola,

FL, United States; and Dynaport MoveMonitor, McRoberts BV, The Hague, The

Netherlands) were used to measure the direct physical activity levels of the patient.


Patients were instructed to wear both monitors at same time, at least 10 hours per

day, during 14 days from visit 1 to visit 2, and from visit 3 to visit 4 (Figure 1). From

Actigraph, we obtained the following variables: wearing time, steps per day, vector

magnitude units (VMU) daily average, and time in moderate-to-vigorous physical

activity per day. From Dynaport, the following variables were obtained: wearing time,

steps per day, time in locomotion per day, standing time per day, VMU daily average,

and intensity.

Other assessments. At baseline (visit 1), patients were evaluated for body

composition by bioelectrical impedance analysis (BIA); lung function testing by

spirometry and reversibility test and body plethysmography; gas transfer (TLCO);

pulse oxymetry (SpO2); exercise tolerance by six-minute walking test (6MWT); and

skeletal muscle function by quadriceps maximal voluntary contraction (QMVC). For

exacerbated patients group, lung function testing and 6MWT were performed at visit

4. We also recorded at baseline demographics, smoking, and patient characteristics

(including baseline exacerbation characteristics for those patients included in

exacerbated group). Clinical data (medical, surgical, COPD and COPD exacerbation

histories, and concomitant treatments) were obtained from medical records.

Socioeconomic status was defined, from questions on occupation and employment

characteristics, according to the National Statistics Socio-economic Classification

(NS-SEC) in five classes version (I Professional occupations, II Managerial and

technical occupations, III Skilled occupations (non-manual and manual), IV Partly

skilled occupations, V Unskilled occupations) (E7). Emotional status using Hospital

Anxiety and Depression Scale (HADS) (E8) was also assessed, only at baseline,

using the PHT LogPad® System. Finally, dyspnea using the modified Medical

Research Council Dyspnea scale (mMRC), and a health related quality of life


package containing Chronic Respiratory Disease Questionnaire (CRQ) (E9), Clinical

COPD Questionnaire (CCQ) (E10) and COPD Assessment Test (CAT) (E11) were

assessed at all visits using the PHT LogPad® System (Figure 1). All questionnaires

were on linguistic adaptation for each site.

Safety issues. Since the study did not involve a study drug, only Serious Adverse

Events (SAE) and Discontinuation due to Adverse Events (DAE) were collected.

Statistical Analysis

Analysis Sets

The analyses sets were defined based primarily on the data of the Daily and Clinical

visit PROactive PROs, as follows:

- Full Analysis Set (FAS) was defined as the set of patients who fulfilled the

following: (i) had answered at least one question from at least one day of the

Daily PROactive PRO, or (ii) had answered at least one question from at least

one administration of the Clinical visit PROactive PRO.

- The Item Reduction Analysis Set for the Daily PROactive PRO (IRAS-D) was

defined as the subset of FAS patients who had completed all items for at least 3

(not necessarily consecutive) days during their first week of filling in the Daily

PROactive PRO. Data from all available days for each subject (maximum of 14

days for patient) were used in the analyses. The Item Reduction Analysis Set for

the Clinical visit PROactive PRO (IRAS-C) was defined as the subset of FAS

patients who had completed all the items for their first administration of the

Clinical visit PROactive PRO. Data from the two Clinical visit PRO for each

subject were used in the analyses.


- The Test-Retest Analysis Set for the Daily PROactive PRO (TRAS-D) was

defined as the subset of FAS patients who had (i) answered at least one question

(and the same question) on at least 3 days (not necessarily consecutive) from

each week of filling in the Daily PROactive PRO, (ii) their daily activity had not

altered significantly between the 2 weeks, and (iii) had not suffered an

exacerbation between the 2 weeks. The Test-Retest Analysis Set for the Clinical

visit PROactive PRO (TRAS-C) was defined as the subset of FAS patients who

had (i) answered at least one question (and the same question) from both

administrations of the Clinical visit PROactive PRO, (ii) their daily activity had not

altered significantly between the 2 weeks, and (iii) had not suffered an

exacerbation between the 2 weeks.

- Construct Validity Analysis Sets (CVAS-D and CVAS-C) was defined as the

subset of IRAS-D and IRAS-C, respectively, which had data on at least one of the

following variables: FEV1, 6-min walking distance, dyspnea, quadriceps strength,

CRQ, CAT, or CCQ scores.

Sample size calculations

The sample size for this study was based on the test-retest validation analysis of the

Clinical visit PROactive PRO using the method described in Flack et al 1988 (E12).

Sample size calculations were performed to detect that the Cohen’s κ between two

separate administrations of the question was significantly greater than 0.4 with a

precision of 0.2 at the 5% level. Assuming a five-item question with item probabilities

of 0.07, 0.08, 0.10, 0.15 and 0.6, the required sample size was 166. For

convenience, this was rounded to 170 patients. Because the test-retest analysis was

to be performed using the TRAS-C, a subset of patients expected to be around 85%

of the total number of patients, we calculated the number of patients to be 200 (200 =


170 + (15% of 200)). Furthermore, an additional percentage of patients was expected

from the exacerbated group who, by definition, would not be eligible for the test-retest

analysis (because their physical activity can change during the study) and who at

baseline would have virtually no physical activity at all. Data from the literature

suggests that at about 20% of COPD patients are completely inactive (E13), so the

figure of 200 was upgraded to 250 patients (250 = 200 + (20% of 250)). Finally, this

sample size was increased by approximately 10% to allow for attrition. Therefore the

final sample size was set at 280 patients.

This figure also fit well with requirements of sample size for factor analysis (one of

the main analysis to be performed), where N:p ratios above 5, being N was the

number of patients and p the number of items, were considered adequate (E14–

E16). In this study, 280 patients equated to N:p ratios of approximately 11 for the

Daily PROactive PRO (23 items) and approximately 7 for the Clinical visit PROactive

PRO (34 items).

Treatment of missing data

The electronic devices for the PROs did not allow missing values in individual items

of any of the PROactive questionnaires, so no strategies to account for missing data

were used.

Descriptive results

Baseline characteristics and physical activity monitors were summarized according to

number and percentage for qualitative variables, mean and standard deviation for

quantitative variables with normal distribution, and median and 25th-75th percentiles

for quantitative variables with non-normal distribution. Comparisons between sites

and between arms were conducted for description purposes.


Item reduction – datasets and variables

The item reduction process was conducted separately for Daily and Clinical visit

versions of PROactive PROs using IRAS-D and IRAS-C, respectively. For the Daily

PROactive PRO, the analyses were performed choosing at random one day, while

for the Clinical visit PROactive PRO one of the two administrations was chosen at

random. The item reduction followed a systematic iterative process (Figure 2) that

was based on the following criteria: (i) floor and ceiling effects; (ii) fitting

unidimensionality; (iii) redundancy of items; (iv) ordering of categories; and (v)

differential item functioning. Additionally, information from patients’ interviews, focus

groups, cognitive debriefings and Advisory Board advice were considered during

personal meetings (11 May 2012 in Paris, 26-27 June 2012 in Barcelona, 18 March

2013 in Leuven, 27 June 2013 in Brussels, 10 July 2013 in London, and 18 July 2014

in Munich) and periodic phone discussions (25 April 2012, 30 May 2012, 7 June

2012, 6 July 2012, 18 July 2012, 29 August 2012, 29 November 2012, 12 December

2012, 6 February 2013, and 12 June 2013) prior to removal of items or as supportive

to keep items that statistically might not perform perfectly well (Figure 2).

We envisaged that the PROs did not capture well information on the amount of

physical activity, both Daily and Clinical visit PROs were analyzed alone and in

combination with activity data from each monitor (analyzed separately). Therefore,

the item reduction process was done with six sets of variables: (i) items from the

Daily PRO, (ii) items from the Daily PRO with variables from Dynaport activity

monitor, (iii) items from the Daily PRO with variables from Actigraph activity monitor,

(iv) items from the Clinical visit PRO, (v) items from the Clinical visit PRO with

variables from Dynaport activity monitor, and (vi) items from the Clinical visit PRO

with variables from Actigraph activity monitor. For the Daily PRO, activity monitors


variables were obtained from the same exact day than PRO items; for the Clinical

visit PRO, the median values of accelerometers variables from each week of

measurement were included. For the item reduction, variables from activity monitors

were categorized both using cut-offs from the literature and quintiles (details

available from the authors). We foresaw that activity monitors data would only be

incorporated into the final PROactive Physical Activity in COPD (PPAC) instruments

if the information it provided was not redundant, according to the inter-item

correlations and infit and outfit values.

Finally, several sensitivity analyses were done using different sets of days, or

different categories of variables/items (details available from the authors).

Item reduction – statistical analysis

The following analyses were performed for each dataset of those mentioned above at

each iteration.

Floor effect and ceiling effects. Items with 50% of patients in either the top or lower

category were flagged for exclusion (E17).

Exploratory Factor Analysis. Exploratory factor analysis was performed to inform

about dimensionality of the PROs. Factors with eigenvalues>1 were retained and

considered to identify different dimensions if the ratio of first to second eigenvalue

was ≥4 (E17, E18). After promax rotation, items were assigned to a factor if the

largest factor loading was greater than |0.3| and at least twice as big as the second

largest loading (E17). Items with all factors loading smaller than |0.3| were

considered for removal.


Item-to-total score correlation. Item-to-total score correlation was calculated as the

Pearson correlation coefficient between each item and the sum of all (remaining)

items. Item to total score correlation was expected to be high, so items with values

smaller than |0.5| were flagged for exclusion (E11).

Inter-item correlation. Pairwise inter-item correlations were computed using the

Pearson correlation coefficient. Items with high inter-item correlation (>|0.8|) were

flagged because they indicate potential redundancy, and those with low inter-item

correlation (<|0.2|) were flagged because they indicate that the item does not fit with

the other items (E17).

Rasch analysis. We fitted the polytomous generalization of the Rasch model, the

rating scale model (E19) and we checked the following properties: (1) Ordering of

response categories for each item: we flagged for exclusion items in which the

ordering of the thresholds did not follow the logical sequence (E20, E21); (2) Item fit

statistics: items with values <0.8 for information-weighted fit statistic (infit) and <0.7

for the outlier-sensitive fit statistic (outfit) were flagged for exclusion since they can

indicate redundancy (E21); items with values >1.2 for infit and >1.3 for outfit were

flagged for exclusion because they probably measure a different concept than the

overall scale. The chi-squared fit statistic was used to have a ranking of the least

well-fitting items (i.e., to decide which item exclude first in case several fulfilled infit

and/or outfit criteria for exclusion), because significant chi-squared statistics indicate

bad fit to the unidimensional model (E20, E21). (3) Person item map: the person item

map displays the location of items and thresholds along with the distribution of

persons along the final scale. In this plot, we checked whether the mean of items was

close to the mean of patients, indicating that the items are well targeted to the

patients (E21), whether items were located along the whole scale, thus covering a


wide range, and on which part of the scale each item has more discriminating power.

(4) Overall fit of the model: the person separation index (PSI) was calculated and

indicates the ability (precision) of the instrument to differentiate between different

people’s physical activity. Values greater than 0.8 were considered to indicate good

performance of the scale, with appropriate ability to discriminate different physical

activity in the patients (E21).

Differential item functioning. We evaluated differential item functioning (DIF)

according to sex and site using a hybrid approach that combined ordinal logistic

regression and item response theory (E22). Items were flagged if they showed a p-

value less than 0.01 to any of the likelihood ratio test (uniform DIF, non-uniform DIF,

and total DIF), showed a MC Fadden pseudo R2 higher than 0.13, or a 10%

difference in the coefficient for physical activity when the group variable (sex or site)

and its interaction entered the model (E23). Content experts helped to determine

whether items with DIF were central to the meaning of the construct and needed to

be retained.

Confirmatory factor analysis. Confirmatory factor analysis (CFA) using structural

equation modeling (SEM) was used to test the fit of the final PROactive Physical

Activity in COPD (PPAC) instruments with the dimensionality identified during item

reduction process. It was done separately for Daily and Clinical visit PPAC using,

respectively, a random day not used in previous analyses, and the remaining Clinical

visit administration at visit 1 and visit 3 that was not used before in the analyses. The

SEM model imposed the following structure: a number of factors derived from

previous analysis, each item contributing to at least on factor, and allowing

correlation between factors if more than one were included. The fit of the SEM model

was evaluated using several indices commonly used in CFA, namely the root mean


square error of approximation (RMSEA), the comparative fit index (CFI), the Non-

Normed Fit Index (NNFI) and the standardized root mean square residual (SRMR)

(E18, E24), considering an ideal performance if RMSEA<0.05, CFI>0.95, NNFI>0.92,

and SRMR <0.08, and no items loaded <0.3 (E18).

Developing equivalences between activity monitors.

A process was done, separately for Daily and Clinical visit versions using IRAS-D

and IRAS-C, respectively, to identify cut-offs of the variables from the activity

monitors that provided the same information to the final versions of PPAC. In order to

do so, we built regression analyses predicting the value of a physical activity variable

from one monitor (e.g., steps from Actigraph) with the same physical activity variable

from the other monitor (i.e., steps from Dynaport), after appropriate normalization if

required. Goodness of fit was assessed by means of normality of residuals,

heteroscedasticity, linearity, collinearity and identification of influential data. Then,

using the cut-offs of the final PPAC version with one of the monitors (identified as

defined above), we calculated the value of cut-offs for the other monitor and tested

performance in the Rasch model. We repeated the process using the second monitor

as the basis. After identifying cut-offs that were equivalent according to regression

models, and that provided same Rasch analysis results, we tested agreement

between such cut-offs.

Initial validation of the PROactive instruments

The initial validation involved reliability (covering internal consistency and test-retest

reliability) and construct validity (covering convergent, known-groups and

discriminant validity). All analyses were performed for the final Daily and Clinical

PPAC instruments (D-PPAC and C-PPAC, respectively), separately for each


dimension in case the instruments had exhibited more than one dimension. The

following tests were performed:

Internal consistency. To evaluate internal consistency, Cronbach’s alpha was

calculated for the D-PPAC and C-PPAC, separately, using TRAS-D and TRAS-C.

Their values were considered appropriate if between 0.70 and 0.90 (E21). For the D-

PPAC, Cronbach’s alpha were calculated for each day and also using the 1-week

average of each item, resulting in two values of Cronbach’s alpha, one for the first 7

days of daily assessments (week 1 for arm 1 / week 5 for arm 2) and one for the

second week of daily assessments (week 2 for arm 1 / week 6 for arm 2). For the C-

PPAC Cronbach’s alpha were calculated for each assessment period, resulting in

two values of Cronbach’s alpha, one for the first assessment (visit 3 for arm 1 / visit 1

for arm 2) and one for the second assessment (visit 4 for arm 1 / visit 2 for arm 2).

Test-retest reliability. Test-retest for the D-PPAC was performed on the TRAS-D

dataset. For patients randomised to arm 1, the score from days 1-7, week 1 was

compared to the score from days 1-7, week 2, separately for each of the seven days.

For patients randomised to arm 2, the score from days 1-7, week 5 was compared to

the score from days 1-7, week 6, separately for each of the seven days. In addition,

the average score across the first 7 days of daily assessments (week 1/week 5) and

the average score across the 7 days of the second week of daily assessments (week

2/week 6) were calculated and tested for reliability. Test-retest reliability for the C-

PPAC was performed on the TRAS-C dataset. For patients randomised to arm 1, the

response to each item on day 1, week 1 were compared with their response to the

same score on day 7, week 2. For patients randomised to arm 2, the response to

each item on day 1, week 5 were compared with their response to the same item on

day 7, week 6. Patients from both sequences were pooled for analysis. The


agreement between the final scales in the two time points (single administrations plus

1-week average for the D-PPAC and single administrations for C-PPAC) was

assessed using the intra-class correlation coefficient (ICC) and Bland-Altman plot

(E25) and considering desirable values of ICC greater than 0.8 (E21).

Construct validity refers to whether an instrument measures the unobservable

construct that it purports to measure. Several specific types of validity were explored

to support construct validity, namely: convergent, known-groups and discriminant

validity.

Convergent validity. Using the CVAS-D and CVAS-C datasets, we explored the

correlations between the PPAC instruments (and their potential dimensions

subscales) and (some dimensions of) related constructs, namely dyspnoea (mMRC),

exercise tolerance (6MWD), physical activity amount (accelerometers), and HRQL

(CRQ, CCQ, CAT). A matrix of expected correlations for each variable was built

using bibliography at the time of analysis. Pearson or Spearman correlation

coefficients were calculated. Correlations lower than 0.3 were considered weak,

correlation between 0.3 and 0.5 were considered moderate, and correlations greater

than 0.5 were considered strong. Correlations less than 0.9 were expected so that

the two measures provide different information (E21). Calculation of the correlations

was repeated for every visit in which the PROs and each construct were collected

(e.g. visits 1, 2, 3 and 4 for mMRC). Each construct was compared to the C-PPAC

obtained in the closest visit and with the closest day of the D-PPAC, as well as with

the average of the week before clinical visit.

Known-groups validity. The PPAC instruments (and their potential dimensions

subscales) were compared (i) across mMRC grades of dyspnoea (collapsing 0-1, 2-


3, and 4), respectively, using ANOVA test; (ii) between stable and exacerbated

patients using a t-test; and (iii) across levels of physical activity defined according to

the monitors using a t-test, ANOVA, or other tests required depending on data

distribution. These comparisons were done for each visit where both PROactive

scores and the groups of interest are available.

Discriminant validity. The PPAC instruments (and their potential dimensions

subscales) were correlated to expected unrelated constructs, namely height, income

category or socioeconomic status. Pearson correlation coefficients were calculated.

Low correlations were expected (<0.3). Calculation of the correlations was repeated

for every visit in which the PROs and each construct were collected. Each construct

was compared to the C-PPAC obtained in the closest visit and with the closest day of

the D-PPAC, as well as with the average of the week before clinical visit.


List of proposed items for day-to-day (Daily) assessment

1. How much walking did you do outside today?

2. How many chores did you do inside the house today? Some examples are

cleaning, doing the laundry or mending things.

3. How many chores did you do outside the house today? Some examples are

gardening, taking the rubbish out, or doing small errands.

4. How much physical leisure activity did you do today? Some examples are

swimming, cycling or going out.

5. How much difficulty did you have getting dressed today?

6. How much difficulty did you have with carrying things you needed to today?

7. Did you avoid climbing stairs today because of your lung problems? OR How

much difficulty did you have climbing stairs today?

8. Did your lung problems prevent you from taking a shower today? OR How

much difficulty did you have showering today?

9. Did your lung problems prevent you from taking a bath today? OR How much

difficulty did you have taking a bath today?

10. How much difficulty did you have bending over today (for instance to put on

your socks or tie your shoelaces)?

11. How much difficulty did you have washing yourself today?

12. How much difficulty did you have walking up a small slope today?

13. How much difficulty did you have when hurrying today (for instance to catch a

bus or to finish your work in time)?

14. How often did you avoid doing activities because of your lung problems today?

15. How breathless were you in general during your activities today?


16. How often did you lack physical strength to do things because of your lung

problems today?

17. How often did you experience lack of strength in your legs during your

physical activities today?

18. How tired were you in general during your activities today?

19. How often did you have to take breaks during your physical activities today?

20. How often did you have to pace yourself during your physical activities today?

21. How often did your lung problems prevent you from doing activities that you

needed to do today?

22. How breathless were you when walking on level ground indoors and outdoors

today?

23. How often did you have to slow down while walking today?

24. How breathless were you when climbing stairs today?

25. How much time did you need to recover from your physical activities today?

26. Did you need to spread your activities throughout the day today because of

your lung problems?

27. Did your lung problems stop you from doing the physical activities that you

wanted to do today?

28. How many puffs of [insert name of rescue medication here] in addition to your

regularly used medication did you need to take for your physical activities

today?

29. Did you need to consider your lung problems when you planned your activities

today? Examples are a trip out, an appointment or expecting visitors.


30. How much help from others did you need with any of your activities today?

Please consider all activities. Examples are household chores, shopping or

getting dressed.


List of proposed items for Clinic visit assessment

1. In the past 7 days, how much walking did you do outside?

2. In the past 7 days, how many chores did you do inside the house? Some

examples are cleaning, doing the laundry or mending things.

3. In the past 7 days, how many chores did you do outside the house? Some

examples are gardening, taking the rubbish out, or doing small errands.

4. In the past 7 days, how much physical leisure activity did you do? Some

examples are swimming, cycling or going out.

5. In the past 7 days, how much difficulty did you have getting dressed?

6. In the past 7 days, how much difficulty did you have with carrying things you

needed to?

7. In the past 7 days, did you avoid climbing stairs because of your lung

problems? OR In the past 7 days, how much difficulty did you have climbing

stairs?

8. In the past 7 days, how much difficulty did you have showering?

9. In the past 7 days, how much difficulty did you have bathing?

10. In the past 7 days, how much difficulty did you have bending over (for instance

to put on your socks or tie your shoelaces)?

11. In the past 7 days, how much difficulty did you have washing yourself?

12. In the past 7 days, how much difficulty did you have walking up a small slope?

13. In the past 7 days, how much difficulty did you have getting out and about?

14. In the past 7 days, how much difficulty did you have when hurrying (for

instance to catch a bus or to finish your work in time)?

15. In the past 7 days, how often did you avoid doing activities because of your

lung problems?


16. In the past 7 days, how breathless were you in general during your activities?

17. In the past 7 days, how often did you lack physical strength to do things

because of your lung problems?

18. In the past 7 days, how often did you experience lack of strength in your legs

during your physical activities?

19. In the past 7 days, how tired were you in general during your activities?

20. In the past 7 days, how often did you have to take breaks during your physical

activities?

21. In the past 7 days, how often did you have to pace yourself during your

physical activities?

22. In the past 7 days, how often did your lung problems prevent you from doing

activities that you needed to do?

23. In the past 7 days, how often did you cough during your physical activities?

24. In the past 7 days, how breathless were you when walking on level ground

indoors and outdoors?

25. In the past 7 days, how often did you have to slow down while walking?

26. In the past 7 days, how breathless were you when climbing stairs?

27. In the past 7 days, how much time did you need to recover from your physical

activities?

28. In the past 7 days, did you need to spread your activities throughout the day


29. In the past 7 days, did your lung problems stop you from doing the physical

activities that you wanted to do?


30. In the past 7 days, how many puffs of [insert name of rescue medication here]

in addition to your regularly used medication did you need to take for your

physical activities?

31. In the past 7 days, did you need to consider your lung problems when you

planned your activities because of your lung problems? Examples are a trip

out, an appointment or expecting visitors.

32. In the past 7 days, how much help from others did you need with any of your

activities? Please consider all activities. Examples are household chores,

shopping or getting dressed.

33. In the past 7 days, how often did you exercise to maintain or improve your

physical condition?

34. In the past 7 days, how often did you use aids to facilitate your physical

activities? Some examples are a wheeled walker, stair lift, or a chair in the

shower.

35. In the past 7 days, how often did you overexert yourself during your physical

activities?


Table E1. Baseline demographic and clinical characteristics of COPD patients stratified by sites

Athens

(n = 49)

m (SD) / n (%)

Edinburgh

(n = 45)

m (SD) / n (%)

Groningen

(n = 39)

m (SD) / n (%)

Leuven

(n = 54)

m (SD) / n (%)

London

(n = 49)

m (SD) / n (%)

Patient status at recruitment

Stable 45 (92) 43 (96) 39 (100) 49 (91) 45 (92)

Exacerbated 4 (8) 2 (4) 0 (0) 5 (9) 4 (8)

Age (years) 66.2 (8.0) 71.7 (7.4) 64.0 (9.6) 66.3 (6.5) 68.7 (9.1)

Male 38 (78) 28 (62) 24 (62) 42 (78) 28 (57)

Primary ethnicity: White 49 (100) 45 (100) 38 (97) 54 (100) 45 (92)

Marital status:

Married 30 (62) 26 (58) 25 (64) 40 (74) 27 (55)

Single 4 (8) 2 (4) 5 (13) 2 (4) 9 (18)

Widow 8 (16) 12 (27) 5 (13) 5 (9) 5 (10)

Divorced 7 (14) 5 (11) 4 (10) 6 (11) 6 (12)

Other 0 (0) 0 (0) 0 (0) 1 (2) 2 (4)

Living:

Alone 15 (31) 17 (38) 12 (31) 54 (100) 19 (39)

Family 34 (69) 28 (62) 27 (69) 0 (0) 30 (61)

Education:

None 0 (0) 0 (0) 0 (0) 0 (0) 0 (0)

Primary school 14 (29) 0 (0) 7 (18) 20 (37) 2 (4)

Secondary school/High school 27 (55) 39 (87) 25 (64) 29 (54) 33 (67)

University 7 (14) 3 (7) 6 (15) 5 (9) 13 (27)

Post graduate 1 (2) 3 (7) 1 (3) 0 (0) 1 (2)

Socioeconomic status

I - Professional occupation 1 (2) 2 (4) 2 (5) 1 (2) 3 (6)

II - Managerial and technical occupation 11 (22) 5 (11) 13 (33) 7 (13) 21 (43)

III - Non-manual skilled occupation 5 (10) 14 (31) 10 (26) 9 (17) 8 (16)

III - Manual skilled occupation 21 (43) 13 (29) 9 (23) 27 (50) 15 (31)


Athens

(n = 49)

m (SD) / n (%)

Edinburgh

(n = 45)

m (SD) / n (%)

Groningen

(n = 39)

m (SD) / n (%)

Leuven

(n = 54)

m (SD) / n (%)

London

(n = 49)

m (SD) / n (%)

IV - Partly skilled occupation 7 (14) 6 (13) 5 (13) 8 (15) 1 (2)

V - Unskilled occupation 4 (8) 5 (11) 0 (0) 2 (4) 1 (2)

Working status:

Employed 4 (8) 1 (2) 12 (31) 6 (11) 5 (10)

Unemployed 2 (4) 3 (7) 4 (10) 7 (13) 3 (6)

Retired 43 (88) 41 (91) 23 (59) 41 (76) 41 (84)

Current smoker 5 (10) 7 (16) 7 (18) 20 (37) 4 (8)

Pack-years 91.6 (51.9) 53.3 (32.0) 35.0 (21.6) 55.9 (38.0) 45.5 (24.9)

Weigth (kg) 76.8 (17.8) 80.5 (19.1) 80.0 (15.5) 76.5 (16.4) 74.3 (17.5)

Heigth (cm) 168.8 (7.6) 166.7 (10.3) 172.9 (10.3) 169.4 (7.9) 168.1 (9.2)

BMI (kg/m2) 27.0 (6.2) 28.8 (5.8) 26.6 (3.6) 26.6 (5.1) 26.3 (6.0)

FFMI (kg/m2)* 18.1 (2.3) 18.4 (3.0) 18.2 (2.7) 18.2 (3.3) 17.8 (3.5)

FEV1 (% predicted) 46.9 (15.3) 61.6 (20.3) 62.3 (15.6) 61.9 (21.9) 53.6 (23.2)

FVC (% predicted) 80.4 (19.7) 100.2 (21.1) 100.9 (14.6) 99.7 (17.6) 98.2 (16.2)

FEV1/FVC (%) 46.5 (13.4) 48.1 (12.4) 49.6 (11.3) 48.2 (12.3) 42.5 (15.2)

IC/TLC (%)* 31.5 (9.5) 38.5 (8.6) 39.2 (8.3) 31.4 (10.5) 33.6 (9.6)

RV/TLC (%)* 51.7 (12.6) 48.9 (9.3) 47.3 (10.3) 51.9 (13.0) 54.0 (9.8)

TLCO (%predicted)* 52.9 (22.9) 59.5 (19.7) 67.0 (21.4) 63.7 (22.6) 56.9 (24.2)

ATS/ERS stages*

I - mild (FEV1≥80%) 0 (0) 10 (23) 4 (10) 12 (22) 8 (16)

II - Moderate (FEV1<80% and ≥50%) 21 (43) 20 (46) 25 (64) 25 (46) 17 (35)

III - Severe (FEV1<50% and ≥30% 19 (39) 12 (27) 10 (26) 14 (26) 16 (33)

IV - very severe (FEV1<30%) 9 (18) 2 (5) 0 (0) 3 (6) 8 (16)

6-MWD (m)* 356.3 (99.2) 403.9 (124.8) 472.3 (91.7) 500.5 (135.6) 403.8 (129.9)

Quadriceps strength (kg)* 27.7 (8.2) 37.6 (12.7) 32.5 (14.8) 34.1 (10.0) 27.5 (10.4)

Previous admissions for COPD exacerbation

Yes 32 (65) 11 (24) 3 (8) 29 (54) 20 (41)

No 17 (35) 34 (76) 36 (92) 25 (46) 29 (59)


Athens

(n = 49)

m (SD) / n (%)

Edinburgh

(n = 45)

m (SD) / n (%)

Groningen

(n = 39)

m (SD) / n (%)

Leuven

(n = 54)

m (SD) / n (%)

London

(n = 49)

m (SD) / n (%)

Comorbidities

Coronary heart disease 3 (6) 13 (29) 3 (8) 7 (13) 2 (4)

Any cardiovascular disease or disorder** 25 (51) 27 (60) 21 (54) 35 (65) 19 (39)

Diabetes 3 (6) 3 (7) 5 (13) 7 (13) 3 (6)

Musculoskeletal disorders 1 (2) 7 (15) 0 (0) 11 (20) 8 (16)

Dyspnea (mMRC 0-4):

0 2 (4) 1 (2) 11 (28) 10 (19) 5 (10)

1 9 (18) 12 (27) 21 (54) 20 (37) 14 (29)

2 21 (43) 20 (44) 3 (8) 20 (37) 11 (23)

3 11 (23) 11 (24) 2 (5) 4 (7) 17 (35)

4 6 (12) 1 (2) 2 (5) 0 (0) 2 (4.1)

Dyspnea (mMRC 0-4) 2.2 (1.0) 2.0 (0.8) 1.1 (1.0) 1.3 (0.9) 1.9 (1.1)

CRQ Dyspnea* 5.1 (1.3) 4.4 (1.2) 5.7 (1.3) 4.8 (1.6) 4.3 (1.8)

CRQ Fatigue* 4.4 (1.3) 4.3 (1.3) 4.8 (1.2) 4.4 (1.4) 3.9 (1.3)

CRQ Emotional* 4.6 (1.1) 4.8 (1.4) 5.5 (0.9) 5.0 (1.3) 4.7 (1.2)

CRQ Mastery* 4.9 (1.2) 5.2 (1.4) 6.0 (0.9) 5.2 (1.2) 5.2 (1.4)

CCQ Symptoms* 2.0 (1.0) 2.1 (1.1) 2.0 (0.8) 2.1 (1.0) 2.4 (1.4)

CCQ Functional* 2.1 (1.4) 2.0 (1.2) 1.6 (1.1) 1.8 (1.3) 2.3 (1.5)

CCQ Mental* 1.8 (1.5) 1.5 (1.2) 0.6 (0.8) 0.9 (1.1) 1.8 (1.7)

CCQ Total* 2.0 (1.1) 2.0 (1.0) 1.5 (0.8) 1.7 (1.0) 2.2 (1.3)

CAT* 16.0 (8.1) 15.9 (7.8) 11.2 (6.3) 14.1 (7.9) 17.8 (9.4)

HADS anxiety* 6.0 (4.3) 6.71 (4.0) 3.67 (2.9) 5.07 (4.0) 6.47 (4.7)

HADS depression* 5.4 (3.6) 5.11 (3.1) 3.28 (2.8) 5.53 (3.4) 5.24 (3.8)

BMI: body mass index; FFMI: fat free mass index; FEV1: forced expiratory volume in 1 second; FVC: forced vital capacity; IC: inspiratory capacity; TLC: total

lung capacity; RV: residual volume: TLCO: transfer factor of the lung for carbon monoxide; 6MWD: 6-minute walking distance; mMRC: modified medical


research council dyspnea scale; CRQ: chronic respiratory questionnaire; CCQ: clinical chronic obstructive pulmonary disease questionnaire; CAT: chronic

obstructive pulmonary disease assessment test; HADS: hospital anxiety and depression scale.

* Some values are missing for certain variables: 9 for FFMI, 15 for IC/TLC, 14 for RV/TLC, 8 for TLCO (% pred), 1 for GOLD stages, 3 for 6-minute walking

distance, 3 for quadriceps strength, 88 for CRQ dyspnea, 3 for CRQ fatigue, 3 for CRQ emotional, 3 for CRQ mastery, 1 for CCQ, 2 for CAT, 1 for HADS

anxiety, 1 for HADS depression.

** Including coronary heart disease


Table E2. Description of activity monitor data, stratified by visit and by site

All Athens Edinburgh Groningen Leuven London

VISITS 1 to 2: week 1

Dynaport n=228 n=48 n=42 n=37 n=53 n=48

Wearing time (min/day) 879 (117) 863 (136) 856 (96) 908 (121) 902 (123) 869 (95)

Time in locomotion (min/day) 60 (36) 56 (39) 45 (22) 65 (28) 77 (40) 55 (37)

Standing time (min/day) 155 (64) 148 (63) 142 (60) 175 (67) 166 (66) 145 (59)

Intensity (g) 0.184 (0.030) 0.177 (0.026) 0.176 (0.026) 0.191 (0.027) 0.186 (0.028) 0.192 (0.040)

VMU (VMU/min) 351 (232) 316 (226) 272 (160) 380 (181) 421 (267) 357 (265)

Steps per day 4763 (3129) 4400 (3176) 3477 (1791) 5127 (2433) 6072 (3430) 4525 (3627)

Actigraph n=218 n=47 n=41 n=36 n=50 n=44


Time in MVPA (min/day), median (P25-P75) 5 (1-17) 3 (1-15) 3 (1-8) 7 (1-12) 7 (2-23) 9 (1-23)

VMU (VMU/min) 461 (213) 412 (221) 413 (165) 497 (194) 518 (223) 465 (231)

Steps per day 4345 (2909) 3862 (2861) 3230 (1897) 4878 (2974) 5168 (2753) 4528 (3501)


Dynaport n=191 n=44 n=30 n=32 n=46 n=39




Intensity (g) 0.183 (0.029) 0.177 (0.026) 0.173 (0.022) 0.190 (0.027) 0.181 (0.026) 0.191 (0.037)

VMU (VMU/min) 340 (221) 305 (203) 278 (157) 397 (229) 365 (215) 351 (270)

Steps per day 4871 (3024) 4478 (2875) 3898 (1751) 5505 (3315) 5510 (2934) 4789 (3622)




VMU (VMU/min) 450 (207) 412 (212) 424 (177) 441 (165) 500 (201) 466 (264)

Steps per day 4234 (2913) 3876 (2487) 3325 (1949) 4608 (3579) 4841 (2589) 4552 (3821)



All Athens Edinburgh Groningen Leuven London

Dynaport n=218 n=47 n=39 n=35 n=53 n=44




Intensity (g) 0.184 (0.030) 0.180 (0.025) 0.176 (0.028) 0.188 (0.028) 0.187 (0.026) 0.188 (0.039)

VMU (VMU/min) 335 (220) 306 (210) 277 (157) 350 (187) 395 (250) 334 (252)

Steps per day 4553 (2944) 4177 (2942) 3708 (1751) 4690 (3129) 5670 (2843) 4246 (3429)




VMU (VMU/min) 439 (210) 434 (233) 402 (155) 442 (158) 479 (243) 430 (222)

Steps per day 4069 (2785) 4003 (2897) 3119 (1749) 3551 (2764) 4779 (2845) 4252 (3194)


Dynaport n=190 n=41 n=36 n=29 n=50 n=34




Intensity (g) 0.184 (0.030) 0.177 (0.028) 0.178 (0.024) 0.190 (0.032) 0.187 (0.030) 0.190 (0.037)

VMU (VMU/min) 343 (230) 297 (212) 274 (151) 378 (194) 402 (259) 354 (281)

Steps per day 4820 (3235) 4226 (3106) 3821 2206) 4909 (2980) 5761 (3162) 5137 (4210)




VMU (VMU/min) 446 (219) 448 (249) 400 (182) 464 (187) 474 (227) 444 (235)

Steps per day 4145 (3068) 4086 (3167) 2897 (1907) 4425 (2962) 4825 (3001) 4421 (3773)

Data are presented as mean (SD) or median (P25-P75). VMU: vector magnitude unit; MVPA: moderate-to-vigorous physical activity.


Table E3. Performance of all items from Daily version of PROactive Physical Activity

in COPD (D-PPAC) instrument and Dynaport prior to item reduction

PIM: person item, map; VMU: vector magnitude unit; f1: loading to factor 1; f2: loading to factor 2; na:

not applicable.

*Flagged if >50% "I didn't do this today"

Items not performing well were flagged: in yellow (dimensionality), blue (floor/ceiling), orange

(ordering), and green (redundancy).


Table E4. Performance of all items from Clinical visit version of PROactive Physical

Activity in COPD (C-PPAC) instrument and Dynaport prior to item reduction

PIM: person item, map; VMU: vector magnitude unit; f1: loading to factor 1; f2: loading to factor 2; na:

not applicable.

*Flagged if >50% "I didn't do this"

Items not performing well were flagged: in yellow (dimensionality), blue (floor/ceiling), orange

(ordering), and green (redundancy).


Table E5. Reason for removing items that flagged in at least one predefined criteria

Daily version of PROactive Physical Activity in COPD (D-PPAC) instrument

Factor 1 “Amount of physical activity”

Item / variable Reasons for removal

FROM PRO

How many chores did you do inside the house today?

Not fitting well with the rest of the items

Details/additional comments:

- Item not fitting well with the rest of the items:

o EFA loading <0.3

o item-to-total correlation <0.5

o inter-item correlation <0.2

o outfit >1.3

o infit >1.2

- Item exhibits differential item functioning between genders

- In patients interviews and focus groups, item reported by few percentage of patients

- In patients interviews and focus groups, item revealed differences between genders, which could make the item not applicable to men

- In cognitive debriefings, male not understanding the item (“it applies to females”, while actually it was including “mending things”)

How much physical leisure activity did you do today?

Not fitting well with the rest of the items + no proper ordering



o EFA loading <0.3

o outfit >1.3 in some analyses


o infit >1.2 in some analyses

- Not ordering well in Rasch analysis

FROM DYNAPORT

Standing time Not fitting well with the rest of the items



o infit >1.2

o outfit >1.3

o all other criteria at the limit


- In experimental studies, variable not well related to double labelled water (Rabinovich R. ERJ 2013)

Intensity Not fitting well with the rest of the items



o infit >1.2

o outfit >1.3


Time in locomotion Redundancy


- Redundant in Rasch analysis

o infit <0.8

o outfit <0.7

- Variable well corelated (0.9572) with “steps” which is also in Actigraph and most (all?) existing activity monitors

FROM ACTIGRAPH


Moderate-to-vigorous physical activity

No proper ordering + redundancy




o infit <0.8

o outfit <0.7

- variable highly skewed to the left (small values; median time in MVPA 5 min)

Factor 2 “Difficulty with physical activity”

Item Reasons for removal

How much difficulty did you have with carrying things you needed to today?

Not fitting well with the rest of the items + floor effect


- Among those who performed the task, 48% reported "no difficulty at all"


o infit>1.2

- Low percentage of quotes in individual interview and focus groups

- In cognitive debriefings, item not well understood

How much difficulty did you have climbing stairs today?

Not fitting well with the rest of the items + floor effect + no proper ordering


- 46% of person·days reported not have difficulty climbing stairs today


o infit>1.4

o outfit>1.3


- In interviews and focus groups, item identified as priority (scored 2, in a range from 1 to 5).

- In cognitive debriefings, however, the item is not applicable for patients who have no stairs at home


- Item highly correlated (>0.9) with other that remain in factor 1

How much difficulty did you have bending over today

Not fitting well with the rest of the items + Floor effect + differential item functioning by gender




o infit>1.4

o outfit>1.3

- Item performs differently by gender according to differential item functioning (chi2<0.01)

- In patients' interviews and focus groups, very low proportion of patients are mentioning the item

- Clinical experts’ opinion: difficulties with bending can be related to aspects other than COPD

How much difficulty did you have walking up a small slope today?





o infit>1.4

- Item only applicable where geography has slopes.

- In patients' interviews and focus groups: no priority.

- Item was kept because Athens and Edinburgh patients considered it important. However, 43% and 44% of patient·days "didn't do this today" in these sites, respectively.

- Item well represented by other items (correlation 0.7) remaining in factor 1

- Experts’ opinion: Experience from other PRO developments or translations (e.g., with the CAT) that this is a difficult item to translate

How many puffs in addition to your regularly used medication did you need to take for your physical



- Among those who answered, 50% reported "no puffs in addition to regular medication due


activities today? to activities today"


o infit>1.4

o outfit>1.3

- According to experts opinion (Advisory Board comment): 41% not having prescribed rescue medication is not clinically believable

- According to experts opinion (Advisory Board comment): Rest of items in factor 1 fit with "ease and difficulty" while this item is an effect/result; the question may be relevant but not as a part of the tool; to be considered for validation of the tool

- In cognitive debriefings, some patients don't like the question

Did you need help from others with your physical activities today?



- In Rasch analysis, item redundant: outfit<0.6

- In Rasch analysis, person item map: narrow distribution

- In patients’ interviews and focus groups, item difficult to understand

- In patients’ interviews and focus groups, item reported together with dressing (which is kept in factor 1)

How breathless were you when climbing stairs today?


Additional comments:


o infit>1.4

o outfit>1.3

- In all factor analysis, low factor load

- In patients’ interviews and focus groups, climbing stairs was reported important for those with stairs (but irrelevant for patients with no stairs)

- Item well represented by breathlessness in general, which is kept in factor 1

How often did you experience lack Not fitting well with the rest of the items


of strength in your legs during your physical activities today?



o infit>1.4

o outfit>1.3

- In patients’ interviews and focus groups, patients report problems in legs, weakness, tiredness, soreness (but not lack of leg strength)

- In cognitive debriefings it is suggested that leg problems should be only included in clinical visit version because they are not so frequent.

How much difficulty did you have washing yourself today?

Floor effect + redundancy



o outfit <0.7

- Item well represented by dressing (correlation >0.8), which remains in factor 1

- In patients’ interviews and focus groups, item reported together with dressing, which remains in factor 1

Did you need to consider your lung problems when you planned your activities today?




o outfit <0.7

- Item well represented by other items remaining in factor 1 (correlation >0.7)

- Item included after cognitive debriefing, not from patients’ interviews or focus groups quotes

How often did your lung problems prevent you from doing activities that you needed to do today?




o infit <0.8

o outfit <0.7

- Item well represented by other items remaining in factor 1 also related to planning activities


(correlation >0.7)

- In patients’ interviews and focus groups, item mentioned together with other remaining items

How much difficulty did you have showering today?

Floor effect + no proper ordering




- In patients' interviews and focus groups, low proportion of patients are mentioning the item and represented few quotes

How much difficulty did you have taking a bath today?




- In Rasch analysis, item does not order well

- In patients' interviews and focus groups, low proportion of patients are mentioning the item and represented few quotes

Did your lung problems stop you from doing the physical activities that you wanted to do today?




- Item well represented by most other items that remain in factor 1 (correlation >0.75)

- In patients’ interviews and focus groups, item mentioned together with other related to the planning of activities that remain in factor 1

Did you need to spread your activities throughout the day today because of your lung problems?




- In Rasch analysis, person item map, is very narrow. Removing it doesn't worsen PSI

- Highly correlated (>0.75) with many other remaining in factor 1, of planning and symptoms


- Relevant for patients, as per patients’ interviews and focus groups.

- Experts’ opinion: item could be relevant but may be something that rather is gradually changing and not noted by patients from a day-to-day basis.

How much difficulty did you have when hurrying today?

Floor effect



- Item well represented by other items (correlation 0.7) remaining in factor 1

- Item difficult to interpret in COPD patients: "I didn't do this" means both severe problems to do, or not willing to do so

How much time did you need to recover from your physical activities today?

Redundancy



o infit <0.8

o outfit <0.7

- Item well represented by others remaining in factor 1, in adaptations/planning and symptoms

- In cognitive debriefings, item not well understood by some patients

How often did you have to pace yourself during your physical activities today?

Redundancy



o infit <0.8

o outfit <0.7

- Item well represented by others (r>0.75) remaining in factor 1

- In patients’ interviews and focus groups: item not identified by the patients; the exact wording of pacing was not used by the patients, who rather used words like doing things slower


How breathless were you when walking on level ground indoors and outdoors today?

Redundancy



o infit <0.8

o outfit <0.7

- Highly correlated (>0.7) with other symptoms (breathless, tiredness) and adaptations remaining in factor 1

- Experts’ opinion: Question is complex: "How breathless were you when walking on level ground indoors and outdoors today?"

- In cognitive debriefings the question (originally phrased shorter) was not well understood, and it was rephrased to an even longer sentence

How often did you have to slow down while walking today?

Redundancy



o infit <0.8

o outfit <0.7

- Highly correlated with taking breaks, which remains in factor 1

- In patients’ interviews and focus groups, item reported together with taking breaks, which is kept

- Experts: one of the first problems noted by patients according to clinical experts, but could be primarily relevant for milder patients. Taking breaks is considered a clearer item since it does not have an implicit reference in terms of slowing down from what (e.g., from fast, from “normal” pace...)

How often did you lack physical strength to do things because of your lung problems today?

Redundancy



o infit <0.8


o outfit <0.7

- Highly correlated (>0.7) with items that remain in factor 1

- In patients’ interviews and focus groups, item considered as low priority

Clinical visit version of PROactive Physical Activity in COPD (C-PPAC) instrument

Factor 1 “Amount of physical activity”

Item/variable Reasons for removal

FROM PRO

In the past 7 days, how often did you exercise to maintain or improve your physical condition?




o EFA loading <0.3

o item-to-total correlation <0.5

o inter-item correlation <0.2

o outfit >1.3

o infit >1.2


In the past 7 days, how much physical leisure activity did you do?




o EFA loading <0.3

o outfit close to 1.3

o infit close to 1.2

- In Rasch analysis, item does not order well in person item map.

In the past 7 days, how many chores did you do inside the

Not fitting well with the rest of the items + differential item functioning by gender



house? - Item not fitting well with the rest of the items:

o EFA loading <0.3

o outfit close to 1.3

o infit close to 1.2

- Item exhibits differential item functioning by genders

- In patients interviews and focus groups, item reported by few percentage of patients

- In patients interviews and focus groups, item revealed differences between genders, which could make the item not applicable to men

- In cognitive debriefings, male not understanding the item (“it applies to females”, while actually it was “mending things”)

FROM DYNAPORT

Intensity Not fitting well with the rest of the items



o outfit >1.3

o infit >1.2

o other criteria at the limit

Standing time Not fitting well with the rest of the items



o infit >1.2

o outfit >1.3



- In experimental studies, variable not well related to double labelled water (Rabinovich R. ERJ 2013)


Time in locomotion Redundancy



o infit <0.8

o outfit <0.7

- Variable well correlated (0.9572) with “steps” which is also in Actigraph and most (all?) existing activity monitors

FROM ACTIGRAPH

Moderate-to-vigorous physical activity

No proper ordering + redundancy




o infit <0.8

o outfit <0.7

- Variable very skewed to the left (small values; median daily time in MVPA is 5 min)

Factor 2 “Difficulty with physical activity”

Item Reasons for removal

In the past 7 days, how often did you cough during your physical activities?



- Item not fitting well with the rest of the items

o Item-to-total correlation: 0.46

o Outfit: 2.284

o Infit: 2.021

- Differential item functioning by site

- In patients’ interviews and focus groups, reported by a small minority of patients; more related to asthma than to COPD


- In cognitive debriefings, answer not related to activities but in general

In the past 7 days, how much difficulty did you have bending over?

Not fitting well with the rest of the items + Floor effect + differential item functioning by gender


- 4% report not bending over

- 2% report not bending over in both clinical visit assessments


o Outfit: 1.57

o Infit: 1.39

- Differential item functioning by sex

- In patients' interviews and focus groups, very low proportion of patients are mentioning the item

- Clinical experts: difficulties with bending can be related to other aspects than COPD

In the past 7 days, did you experience lack of strength in your legs during your physical activities?




o Outfit: 1.83

o Infit: 1.68

- Item captured by related items (kept at the prefinal list): correlated with tiredness in general (0.60)

- In patients’ interviews and focus groups, patients report problems in legs, weakness, tiredness, soreness (but not lack of leg strength)

- In cognitive debriefings, leg problems visit are not so frequent.

In the past 7 days, how often did you overexert yourself during your physical activities?




o Outfit: 1.82


o Infit: 1.67

- In cognitive debriefing, item phrased as “overdo” and not well understood

- Clinical experts: difficult interpretation, patient may be avoiding it

In the past 7 days, did your lung problems prevent you from doing activities that you needed to do?

Redundancy + no proper ordering



o infit <0.8

o outfit <0.7

- Item captured by related items (kept on prefinal list): correlated with avoid doing activities (0.79), lack physical strength (0.79).

- In patients’ interviews and focus groups, item mentioned together with other remaining items

In the past 7 days, how much difficulty did you have carrying objects?

Not fitting well with the rest of the items + differential item functioning by site + interpretation problems


- 8% report not carrying things.

- 4% report not carrying things in both clinical visit assessments.


o Infit: 1.27


- In patients’ interviews and focus groups, low percentage of quotes

- In cognitive debriefings, item not well understood

In the past 7 days, how much difficulty did you have when hurrying?

Not fitting well with the rest of the items + interpretation problems


- 32% report not hurrying.

- 21% report not hurrying in both clinical visit assessments.



o Infit: 1.26

- Clinical experts: Item difficult to interpret in COPD patients: "I didn't do this" means both severe problems to do, or no willing to

- In patients’ interviews and focus groups: reported by a small proportion of patients

In the past 7 days, how many puffs of rescue medication in addition to your regularly used medication did you need to take for your physical activities?

Not fitting well with the rest of the items + other


- 39% report not having prescribed rescue medication.

- 39% report not having prescribed rescue medication at both clinical visit assessments.


o Outfit: 1.38

o Infit: 1.30

- In cognitive debriefings: some patients report they don’t like the question.

- During PRO development wording resulted difficult

- Experts opinion/Advisory Board: such percentage not having prescribed rescue medication is not clinically believable

- Experts opinion/Advisory Board: It measures the consequence rather than the difficulty

In the past 7 days, how much difficulty did you have showering?



- 55% report no difficulty at all taking a shower.

- 13% report not taking a shower.

- 13% report not taking a shower in both clinical visit assessments.



- In patients’ interviews and focus groups, low proportion of patients is mentioning the item and represented by few quotes.


In the past 7 days, how much difficulty did you have bathing?



- 58% report no difficulty at all taking a bath.

- 46% report not taking a bath.

- 45% report not taking a bath in both clinical visit assessments.


- In patients’ interviews and focus groups, low proportion of patients is mentioning the item and represented by few quotes.

In the past 7 days, how often did you use aids to facilitate your physical activities?



- 76% report never use aids.



o Outfit: 2.87

o Infit: 1.88


- In cognitive debriefings, items exhibits several different interpretations by patients

In the past 7 days, how much difficulty did you have washing yourself?



- 62% report no difficulty at all washing.

- Not ordering well in Rasch analysis.


- In patients’ interviews and focus groups, item reported together with dressing.

In the past 7 days, how much help from others did you need with any of your activities?

Floor effect + differential item functioning by site


- 52% report no help at all (floor effect)



- In patients’ interviews and focus groups, item reported together with dressing (which is kept).

- In cognitive debriefings, item difficult to understand

In the past 7 days, how much difficulty did you have climbing stairs?

No proper ordering


- 8% report not climbing stairs.

- 4% report not climbing stairs in both clinical visit assessments.


o Infit: 1.25



- In cognitive debriefings, item not applicable for patients who have no stairs at home

- Clinical experts: the item is clinically relevant, but, if removed, the theme still captured by related items (kept on prefinal list): correlated with breathlessness on level (0.65), avoid doing activities (0.60) and time to recover (0.60)

In the past 7 days, did you need to spread your activities throughout the day because of your lung problems?

No proper ordering



- Experts: could be relevant but may be something that rather is gradually changing and not noted by patients.

In the past 7 days, how often did you have to pace yourself during your physical activities?

Redundancy



o infit <0.8

o outfit <0.7

- Item not found in WP2b docs because the exact wording of ‘pacing’ was not used by the


patients, who rather used words like ‘doing things slower’.

- Item captured by related items (kept on prefinal list): correlated with difficulty getting out and about (0.63), avoid doing activities (0.66), breathlessness in general (0.67), lack of physical strength (0.69), tiredness in general (0.67), have to take breaks (0.82), breathlessness on level (0.67), time to recover (0.68), and need to consider lung problems (0.70)

In the past 7 days, how often did you have to slow down while walking?

Redundancy



o infit <0.8

o outfit <0.7


- In patients’ interviews and focus groups, item reported together with break, which is kept

- Experts: this item captures one of the first problems noted by patients but difficult to capture in a question. Taking breaks is considered a clearer item since it does not have an implicit reference in terms of slowing down from what (e.g., from fast, from “normal” pace...)


In the past 7 days, did your lung problems stop you from doing the physical activities that you wanted to do?

Redundancy



o infit <0.8

o outfit <0.7



- In patients’ interviews and focus groups, problems in interpretation by patients, because they adapt what they do to what they can do

In the past 7 days, how breathless were you when climbing stairs?

Other: differential item functioning by sites


- 8% report not climbing stairs.

- 4% report not climbing stairs in both clinical visit assessments.


- In cognitive debriefings, item not applicable for patients who have no stairs at home

- Clinical experts: the item is relevant because is the first symptom reported by patients. If removed, the theme is still captured by related items (kept on prefinal list): correlated with avoid doing activities (0.64), breathlessness in general (0.68), lack of physical strength (0.66), have to take breaks (0.63), breathlessness on level (0.73), time to recover (0.65), and need to consider lung problems (0.61)

In the past 7 days, how much difficulty did you have walking up a small slope?

Interpretation problems


- 19% report no walking slope

- 9% report no walking slope in both clinical visit assessments

- In patients' interviews and focus groups: only patients from Athens and Edinburgh reported it as important.

- PRO experts: Experience from other PRO developments/translations (e.g., with the CAT) that this is a difficult item to translate

- Item well represented by others remaining in the final factor 1: correlated with breathlessness in general (0.63), lack of physical strength (0.60), have to take breaks (0.60), and breathlessness on level (0.61)


Table E6. Confirmatory factor analysis results of Daily and Clinical visit versions of PROactive Physical Activity in COPD

instruments (D-PPAC and C-PPAC, respectively)

D-PPAC combined with

Dynaport (n=179) combined with

Actigraph (n=156) C-PPAC

combined with Dynaport (n=199)

combined with Actigraph (n=156)

Items Factor loadings Factor loadings

Items Factor loadings Factor loadings

Factor 1 Factor 2 Factor 1 Factor 2 Factor 1 Factor 2 Factor 1 Factor 2

Walking outside 0.51 0.52 Walking outside 0.62 0.62

Chores outside 0.41 0.39 Chores outside 0.62 0.66

Steps 0.89 0.88 Steps 0.66 0.73

Vector magnitude units 0.90 0.93 Vector magnitude units 0.73 0.61

Difficulty getting dressed 0.71 0.66 Difficulty getting dressed 0.71 0.71

Avoid activities 0.81 0.76 Difficulty getting out 0.77 0.78

Breathless in general 0.90 0.93 Avoid activities 0.83 0.83

Tired in general 0.83 0.82 Breathless in general 0.87 0.86

Take breaks 0.90 0.90 Lack physical strength 0.80 0.81

Tired in general 0.70 0.70

Take breaks 0.76 0.75

Breathless walking 0.81 0.79

Time to recover 0.82 0.79

Consider lung problems 0.77 0.78

Goodness of fit

RMSEA 0.055 0.043

Goodness of fit

RMSEA 0.035 0.038

CFI 0.987 0.992 CFI 0.992 0.989

NNFI 0.979 0.986 NNFI 0.988 0.984

SRMR 0.040 0.046 SRMR 0.035 0.033

D-PPAC: Daily version of PROactive Physical Activity in COPD instrument; C-PPAC: Clinical visit version of PROactive Physical Activity in COPD instrument;

RMSEA: root mean square error of approximation; CFI: comparative fit index; NNFI: non-normed fit index; SRMR: standardized root mean square residual.


Table E7. Performance of items from factor 1 (‘amount’) without variables from the activity monitors, comparing with performance

with final factor 1 (2 items from PRO + 2 variables from the activity monitor (Dynaport)).

Flo

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ep

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Ex

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ac

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an

aly

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Ex

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ac

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an

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:

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Dif

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Daily version (factor 1)

Items from the PRO only

How much walking did you do outside today? 0.79 0.35 0.54 0.54

0.59

0.99

0.37

How many chores did you do inside the house today? 0.47 0.07 1.19 1.14 <0.1 X

How many chores did you do outside the house today? 0.72 0.29 0.69 0.71 0.58

How much physical leisure activity did you do today? 55 0.61 0.20 X 0.69 0.77 0.38

2 final items from the PRO + 2 final variables from Dynaport monitor

How much walking did you do outside today? 0.84 0.59 0.79 0.79

0.83

0.69

0.58

How many chores did you do outside the house today? 0.73 0.46 1.10 1.13 0.49

Steps (total daily) 0.85 0.60 0.63 0.62 0.89

VMU (mean vmu/min) 0.86 0.61 0.53 0.56 0.90


Clinical visit version (factor 1)

Items from the PRO only

In the past 7 days, how much walking did you do outside? 0.71 0.34 0.74 0.76

0.62

0.61

0.33

In the past 7 days, how many chores did you do outside the house? 0.71 0.34 0.74 0.75 0.71

In the past 7 days, how many chores did you do inside the house? 0.66 0.30 0.81 0.83 0.59 X

In the past 7 days, how much physical leisure activity did you do? 0.73 0.36 X 0.66 0.66 0.59

In the past 7 days, how often did you exercise to maintain or improve your physical condition?

0.52 0.19 X 1.35 1.13 0.27

2 final items from the PRO + 2 final variables from Dynaport monitor

In the past 7 days, how much walking did you do outside? 0.74 0.55 0.96 0.98

0.75

0.48

0.53

In the past 7 days, how many chores did you do outside the house? 0.73 0.56 0.85 0.86 0.46

Steps (weekly median) 0.85 0.43 0.60 0.56 0.92

VMU (weekly median) 0.85 0.43 0.57 0.54 0.91

PRO: patient-reported outcome; VMU: vector magnitude units


Table E8. Scores for Daily and Clinical visit versions of PROactive Physical Activity

in COPD instruments (D-PPAC and C-PPAC, respectively), stratified by gender and

severity

D-PPAC Amount with Dynaport Amount with Actigraph Difficulty

Median (P25-P75) Median (P25-P75) Median (P25-P75)

All patients 8 (5-12) 8.5 (5-11) 15 (12-18)

By gender:

Men 8 (5-12) 8 (5-11) 15 (12-18)

Women 9 (5-11) 9 (6-12) 15 (12-18)

By severity:

Mild 12 (7-14) 11 (7-13) 15 (14-20)

Moderate 8 (6-11) 9 (6-12) 16 (13-18)

Severe 9 (5-11) 9 (5-11) 14.5 (11-17)

Very severe 3 (2-6) 4 (3-5) 13 (9-17)

C-PPAC Amount with Dynaport Amount with Actigraph Difficulty

Median (P25-P75) Median (P25-P75) Median (P25-P75)

All patients 9 (7-11) 9 (7-11) 28 (22-34.5)

By gender:

Men 9 (7-11) 9 (7-11) 30 (24-35)

Women 9 (6-12) 9 (7-11) 26.5 (20-33)

By severity:

Mild 10 (8-13) 10 (8-12) 33 (27.5-37)

Moderate 10 (7-12) 10 (8-11) 31 (24.5-35.5)

Severe 8 (6-11) 9 (7-11) 25 (20-31)

Very severe 4 (2-7) 4.5 (2-7.5) 21.5 (14-27)

D-PPAC: Daily version of PROactive Physical Activity in COPD instrument; C-PPAC: Clinical visit

version of PROactive Physical Activity in COPD instrument.


Table E9. Daily and Clinical visit versions of PROactive Physical Activity in

COPD scores (D-PPAC and C-PPAC, respectively) according to dyspnea

groups, exacerbation status at baseline, and physical activity levels (known-

groups validity)

D-PPAC

Factor 1 with Dynaport

median (P25-P75)

Factor 1 with Actigraph

median (P25-P75)

Factor 2 XXXXXXX

median (P25-P75)

Dyspnea

mMRC 0-1 10 (7-13) 10 (7-13) 18 (15-19)

mMRC 2-3 7 (4-10) 8 (5-10) 13.5 (11-16)

mMRC 4 3 (2-8) 3 (3-8) 8.5 (6-10)

p-value <0.001 <0.001 <0.001

Exacerbation status

Stable 9 (5-12) 9 (5-12) 16 (12-18)

Exacerbated 6 (3-8) 6 (5-8) 13 (5-14)

p-value 0.037 0.075 0.030

Physical activity levels

MVPA 1st tertile 4 (3-7) 5 (3-6) 15 (10-18)

MVPA 2nd

tertile 7 (5-10) 8 (6-10) 15 (12-18)

MVPA 3rd

tertile 12 (10-14) 12 (9-14) 16 (13-18)

p-value <0.001 <0.001 0.166

Walktime 1st tertile 4 (3-6) 5 (3-6) 13.5 (10-17)

Walktime 2nd

tertile 8 (7-10) 8 (7-9) 15 (12-18)

Walktime 3rd

tertile 8 (7-9) 12 (11-14) 17 (14-18)

p-value <0.001 <0.001 0.029

Intensity 1st tertile 5 (3-7.5) 5 (4-8) 15 (11-17.5)

Intensity 2nd

tertile 8 (5-11) 9 (6-11) 16 (12-18)

Intensity 3rd

tertile 12 (10-14) 12 (9-14) 16 (14-18)

p-value <0.001 <0.001 0.064

C-PPAC

Factor 1 with Dynaport

median (P25-P75)

Factor 1 with Actigraph

median (P25-P75)

Factor 2 XXXXXXX

median (P25-P75)

Dyspnea

mMRC 0-1 (n=108) 10 (8-12) 10 (9-12) 34 (30-37)

mMRC 2-3 (n=102) 8 (5-10) 8 (6-10) 24 (18-28)

mMRC 4 (n=14) 3.5 (2-5) 4 (2-5) 13.5 (10-22)

p-value <0.001 <0.001 <0.001

Exacerbation status

Stable 9 (7-11) 9 (7-11) 28.5 (23-35)

Exacerbated 4.5 (2-6.5) 4.5 (3-7) 14 (10-24)


p-value <0.001 <0.001 <0.001

Physical activity levels

MVPA 1st tertile 6 (3-8) 6.5 (4-8) 22 (16-30)

MVPA 2nd

tertile 9 (7-11) 9 (7-10) 29 (25.5-35)

MVPA 3rd

tertile 11 (10-13) 9 (7-11) 33 (26-36)

p-value <0.001 <0.001 <0.001

Walktime 1st tertile 5 (3-7) 6 (4-7) 23 (18-29)

Walktime 2nd

tertile 9 (8-11) 10 (8-11) 31 (25-35)

Walktime 3rd

tertile 12 (10-13) 12 (10-13) 31 (25-36)

p-value <0.001 <0.001 <0.001

Intensity 1st tertile 7 (5-9) 7 (5-9) 24.5 (21-31)

Intensity 2nd

tertile 9 (6-11) 9 (6.5-11) 29 (22-33)

Intensity 3rd

tertile 11 (9-13) 9 (7-11) 33 (35-36)

p-value <0.001 <0.001 <0.001

D-PPAC: Daily version of PROactive Physical Activity in COPD instrument; C-PPAC: Clinical

visit version of PROactive Physical Activity in COPD instrument; mMRC: modified medical

research council dyspnea scale; MVPA: moderate-to-vigorous physical activity; factor 1: amount

of physical activity; factor 2: difficulty with physical activity.


Table E10. Correlation of Daily and Clinical visit versions of PROactive Physical

Activity in COPD instruments (D-PPAC and C-PPAC, respectively) with height,

socioeconomic status and heart rate (discriminant validity)

D-PPAC Height SES HR

Factor 1: Amount with Dynaport 0.10 0.02 -0.13

Factor 1: Amount with Actigraph 0.10 0.03 -0.12*

Factor 2: Difficulty 0.05 -0.09 -0.14

C-PPAC Height SES HR

Factor 1: Amount with Dynaport 0.12 -0.06 -0.22*

Factor 1: Amount with Actigraph 0.15 -0.07 -0.20*

Factor 2: Difficulty 0.20* -0.14* -0.21*

* p<0.05

In bold, the observed correlations agreed with the expected correlations set by a panel of

experts. D-PPAC: Daily version of PROactive Physical Activity in COPD instrument; C-PPAC:

Clinical visit version of PROactive Physical Activity in COPD instrument; SES: socioeconomic

status; HR: heart rate.


Figure E1. Person-item maps and overall fit of the model for factor 1 (‘amount’)

of Daily and Clinical visit PROactive PROs without variables from activity

monitors, comparing with performance with final factor 1 (2 items from PRO + 2

variables from the activity monitor (Dynaport))

Plots a) and b) indicate that the items are not well targeted to the patients and

do not cover a wide range of the factor measured. Specifically, the ’physical

leisure activity’ item from the Daily version does not order well into the model.

Person separation index (PSI) value indicates that the factor is not precise

enough to differentiate between different patients’ physical activity experiences.

In contrast, plots c) and d) indicate that the final factor 1 combining PRO items

and two variables of Dynaport are well targeted to the patients and cover a wide


range of the factor measured. Person separation index (PSI) values indicate

that the factor is precise enough to differentiate between different patients’

physical activity experiences.


Figure E2. Bland-Altman test-retest reliability of Daily PROactive Physical Activity in COPD (D-PPAC) instrument – daily values





All Bland-Altman plots include a dotted line at value “0” and a dashed line at the value of the average of the difference. The dashed

extreme lines represent +/- 2SD. Factor 1 interpreted as ‘amount of physical activity’ and factor 2 as ‘difficulty with physical activity’.


Figure E3. Bland-Altman test-retest reliability of Clinical visit version of PROactive Physical Pctivity in COPD (C-PPAC) instrument

All Bland-Altman plots include a dotted line at value “0” and a dashed line at the value of the average of the difference. The dashed

extreme lines represent +/- 2SD. Factor 1 interpreted as ‘amount of physical activity’ and factor 2 as ‘difficulty with physical activity’.


Final version of the Daily of PROactive Physical Activity in COPD (D-

PPAC) instrument

DAILY OF PROACTIVE PHYSICAL ACTIVITY IN COPD: D-PPAC

INSTRUCTIONS TO PATIENTS DAY 1:

Patients with chronic lung disease like you often report that they have problems during physical activity. By physical activity, we mean all activities that require movement of your body. Examples are household activities, walking, going to work, or getting dressed. However, please consider all activities you do, and not only these examples. We would like to know how you experienced your physical activity since you woke up TODAY.

Please complete this questionnaire in the evening before going to bed. Please select the box next to the response that best applies to you TODAY.

There are no wrong answers. We very much value your response.

INSTRUCTIONS FOR SUBSEQUENT DAYS:

We would like to know how you experienced your physical activity since you woke up TODAY. Please complete this questionnaire in the evening before going to bed. Please select the box next to the response that best applies to you TODAY.

Difficulty

score

Amount

score

How much walking did you do outside today?

None at all 0

A little bit (up to 10 minutes in total) 1

Some (up to 30 minutes in total) 2

A lot (up to 1 hour in total) 3

A great deal (more than 1 hour in total) 4

How many chores did you do outside the house today? Some examples are

gardening, taking the rubbish out, or doing small errands.

None at all 0

A few 1

Some 2

A lot 3

A large amount 4

How much difficulty did you have getting dressed today?

None at all 4

A little bit 3

Some 2

A lot 1

A great deal 0

How often did you avoid doing activities because of your lung problems today?

Not at all 4

Rarely 3

Sometimes 2

Frequently 1

http://www.proactivecopd.com/index.php


All the time 0

How breathless were you in general during your activities today?

Not at all 4

A little bit 3

Moderately 2

Very 1

Extremely 0

How tired were you in general during your activities today?

Not at all 4

A little bit 3

Moderately 2

Very 1

Extremely 0

How often did you have to take breaks during your physical activities today?

Not at all 4

Rarely 3

Sometimes 2

Frequently 1

All the time 0

Daily steps score

ST

EP

S

Measured by Actigraph Measured by Dynaport

0 <1000 <1900 0

1 1000-3000 1900-3700 1

2 3000-5000 3700-5500 2

3 5000-7000 5500-7300 3

4 >7000 >7300 4

Daily VMU score

VM

U


0 <100 <50 0

1 100-200 50-110 1

2 200-300 110-190 2

3 300-400 190-270 3

4 400-600 270-440 4

5 >600 >440 5

Amount scores (sum above):

Difficulty scores (sum above):

Total scores (sum above):


Final version of the Clinical visit of PROactive Physical Activity in COPD

(C-PPAC) instrument

CLINICAL VISIT OF PROACTIVE PHYSICAL ACTIVITY IN COPD: C-PPAC

INSTRUCTIONS TO PATIENTS:

Patients with chronic lung disease like you often report that they have problems during physical activity. By physical activity, we mean all activities that require movement of your body. Examples are household activities, walking, going to work, or getting dressed. However, please consider all activities you do, and not only these examples. We would like to know how you experienced your physical activity IN THE PAST 7 DAYS.

Please select the box next to the response that best applies to you IN THE PAST 7 DAYS.

There are no wrong answers. We very much value your response.

Difficulty

score

Amount

score

In the past 7 days, how much walking did you do outside?

None at all 0

A little bit (about 10 minutes every day) 1

Some (about 30 minutes every day) 2

A lot (about 1 hour every day) 3

A great deal (more than 1 hour every day) 3

In the past 7 days, how many chores did you do outside the house? Some

examples are gardening, taking the rubbish out, or doing small errands.

None at all 0

A few 1

Some 2

A lot 3

A large amount 4

In the past 7 days, how much difficulty did you have getting dressed?

None at all 4

A little bit 3

Some 2

A lot 1

A great deal 0

In the past 7 days, how much difficulty did you have getting out and about?

None at all 4

A little bit 3

Some 2

A lot 1

A great deal 0

In the past 7 days, how often did you avoid doing activities because of your lung

problems?

Not at all 4

Rarely 3

Sometimes 2

http://www.proactivecopd.com/index.php


Frequently 1

All the time 0

In the past 7 days, how breathless were you in general during your activities?

Not at all 4

A little bit 3

Moderately 2

Very 1

Extremely 0

In the past 7 days, how often did you lack physical strength to do things


Not at all 4

Rarely 3

Sometimes 2

Frequently 1

All the time 0

In the past 7 days, how tired were you in general during your activities?

Not at all 4

A little bit 3

Moderately 2

Very 1

Extremely 0

In the past 7 days, how often did you have to take breaks during your physical

activities?

Not at all 4

Rarely 3

Sometimes 2

Frequently 1

All the time 0

In the past 7 days, how breathless were you when walking on level ground

indoors and outdoors?

Not at all 4

A little bit 3

Moderately 2

Very 1

Extremely 0

In the past 7 days, how much time did you need to recover from your physical

activities?

None at all 4

A little bit 3

Some 2

A lot 1

A great deal 0

In the past 7 days, did you need to consider your lung problems when you

planned your activities because of your lung problems? Examples are a trip out,

an appointment or expecting visitors.

No 4

A little bit 3

Sometimes 2

A lot 1

A great deal 0


Weekly steps score

ST

EP

S (

we

ek

ly

me

dia

n)


0 <1000 <1500 0

1 1000-2000 1500-2500 1

2 2000-4000 2500-4500 2

3 4000-6000 4500-6500 3

4 >6000 >6500 4

Weekly VMU score

VM

U (

we

ek

ly

me

da

in)


0 <100 <60 0

1 100-200 60-130 1

2 200-300 130-210 2

3 300-500 210-370 3

4 >500 >370 4

Amount scores (sum above):

Difficulty scores (sum above):

Total scores (sum above):


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