Validation of PROMIS in Diverse Populations/Clinical Study: Measuring Change in Fatigue (doi:10.7910/DVN/BWKB4W)

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Part 1: Document Description
Part 2: Study Description
Part 3: Data Files Description
Part 4: Variable Description
Part 5: Other Study-Related Materials
Entire Codebook

Document Description

Citation

Title:

Validation of PROMIS in Diverse Populations/Clinical Study: Measuring Change in Fatigue

Identification Number:

doi:10.7910/DVN/BWKB4W

Distributor:

Harvard Dataverse

Date of Distribution:

2021-06-22

Version:

Bibliographic Citation:

Moinpour, Carol M, 2021, "Validation of PROMIS in Diverse Populations/Clinical Study: Measuring Change in Fatigue", https://doi.org/10.7910/DVN/BWKB4W, Harvard Dataverse, V1, UNF:6:ecEZ4wZUWK40LXdzn7x0Gw== [fileUNF]

Study Description

Citation

Title:

Validation of PROMIS in Diverse Populations/Clinical Study: Measuring Change in Fatigue

Identification Number:

doi:10.7910/DVN/BWKB4W

Authoring Entity:

Moinpour, Carol M (Fred Hutchinson Cancer Research Center)

Distributor:

Harvard Dataverse

Access Authority:

Shen, Shu-En

Depositor:

Shen, Shu-En

Date of Deposit:

2021-06-22

Holdings Information:

https://doi.org/10.7910/DVN/BWKB4W

Study Scope

Keywords:

Medicine, Health and Life Sciences

Abstract:

Evaluate how well three different patient-reported outcomes (PROs) measure individual change. 214 patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT–Fatigue scale, a 7-item PROMIS® Fatigue Short-Form (PROMIS 7a), and the PROMIS® Fatigue computer adaptive test (CAT) were administered monthly online for six months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate-of-change to the estimated total variance of measured individual differences in rate-of-change. Precision of individual measured change, the standard error of measurement (SEM) of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months. A linear model for the reliability of measured change showed the following by 6 and by 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change. These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.

Methodology and Processing

Sources Statement

Data Access

Notes:

Other Study Description Materials

Related Publications

Citation

Title:

Moinpour CM, Donaldson GW, Davis KM, et al. The challenge of measuring intra-individual change in fatigue during cancer treatment. Qual Life Res. 2017;26(2):259-271. doi:10.1007/s11136-016-1372-9

Bibliographic Citation:

Moinpour CM, Donaldson GW, Davis KM, et al. The challenge of measuring intra-individual change in fatigue during cancer treatment. Qual Life Res. 2017;26(2):259-271. doi:10.1007/s11136-016-1372-9

File Description--f4822549

File: de_identified dataset promis reliability measured chg in fatigue_9-11-14.tab

Number of cases: 904
No. of variables per record: 7
Type of File: text/tab-separated-values

Notes:

UNF:6:8ov8Wf6Gr0Old43JdcGsjA==

Calculated scores for fatigue measures

File Description--f4822552

File: SCCA_Clinical Data.tab

Number of cases: 133
No. of variables per record: 10
Type of File: text/tab-separated-values

Notes:

UNF:6:TRZQXTnZkNlP0LRGVuCHGw==

Patient data from Seattle Cancer Care Alliance (SCCA)

File Description--f4822554

File: ST 1 & 2_Clinical_Study_Measuring_Change_in_Fatigue_8-15-2014.tab

Number of cases: 214
No. of variables per record: 13
Type of File: text/tab-separated-values

Notes:

UNF:6:VAtcD1WHN6uTIhPkhpTPoQ==

Complete patient data

Variable Description

List of Variables:

stcode
Assmnt
promiscat - PROMIS "Theta" (2PL IRT Person Estimate)
promissf - Promis Short Form (Mean Item Score)
facit - FACIT (Mean Item Score)
time - Time scaled so that Intercept=Initial Status
deidint_id - deidentified (random) id
Stcode - Stcode
TreatedA's - TreatedA's
CancerType - CancerType
WBCResultStart(THOU/uL) - WBCResultStart(THOU/uL)
WBCResultEnd(THOU/uL) - WBCResultEnd(THOU/uL)
HematocritResultStart(%) - HematocritResultStart(%)
HematocritResultEnd(%) - HematocritResultEnd(%)
InPatient - InPatient
OutPatient - OutPatient
Note - Note
stcode - stcode
Consent - Consent
Gender - Gender
Age - Age
Race - Race
Ethncty - Ethncty
Site - Site
RegCmmnt - RegCmmnt
OffStdy - OffStdy
DiseaseStage - DiseaseStage
#PriorChemoRegiments(0,1,2ormore) - #PriorChemoRegiments(0,1,2ormore)
ResearchSite - ResearchSite
CancerType - CancerType

Variables

stcode

f4822549 Location:

Summary Statistics: Max. 7256.0; Mean 6984.292035398227; Valid 904.0; Min. 6016.0; StDev 368.3038626173868;

Variable Format: numeric

Notes: UNF:6:aJ0P26lgo4ABMcpGLOHHpw==

Assmnt

f4822549 Location:

Summary Statistics: StDev 1.7424050089915435; Valid 904.0; Max. 6.0; Min. 1.0; Mean 3.209070796460176;

Variable Format: numeric

Notes: UNF:6:2I7ngWBjt7fNKSwg6rVbIA==

PROMIS "Theta" (2PL IRT Person Estimate)

f4822549 Location:

Value	Label	Frequency	Text
-999.	IRT Estimate not reported	2

Summary Statistics: Valid 904.0; Min. -999.0; Max. 3.467524; Mean -1.790240572876109; StDev 46.99246131594162;

Variable Format: numeric

Notes: UNF:6:MwWDhD8iLFqVPRen/Etsqw==

Promis Short Form (Mean Item Score)

f4822549 Location:

Value	Label	Frequency	Text
-999.	Missing Item Data	4

Summary Statistics: Min. -999.0; StDev 66.5200046775669; Valid 904.0; Mean -1.825023704171943; Max. 5.0;

Variable Format: numeric

Notes: UNF:6:tQgDICxpE+QK4jnqj7cF+w==

FACIT (Mean Item Score)

f4822549 Location:

Value	Label	Frequency	Text
-999.	Missing Item Data	4

Summary Statistics: Min. -999.0; Mean -2.003604587398838; Max. 5.0; StDev 66.50953651629169; Valid 904.0;

Variable Format: numeric

Notes: UNF:6:95yJBoV0z4ugnMzHgbapgw==

Time scaled so that Intercept=Initial Status

f4822549 Location:

Summary Statistics: Max. 5.0; Valid 904.0; Min. 0.0; Mean 2.209070796460176; StDev 1.7424050089915435;

Variable Format: numeric

Notes: UNF:6:WdWQGInHy3DMAWrR3V1Rfw==

deidentified (random) id

f4822549 Location:

Summary Statistics: Min. 1.0; StDev 61.4628438936891; Valid 904.0; Max. 214.0; Mean 105.58075221238936;

Variable Format: numeric

Notes: UNF:6:fog+pLj3/3spRcTmZ3cOoQ==

Stcode

f4822552 Location:

Summary Statistics: Min. 6016.0; Mean 7053.87969924812; Valid 133.0; Max. 7257.0; StDev 302.8522501453318;

Variable Format: numeric

Notes: UNF:6:QzksPD0KyjzZBoBLbFQOnQ==

TreatedA's

f4822552 Location:

Summary Statistics: StDev 1.6777598470436073; Min. 1.0; Valid 133.0; Max. 6.0; Mean 4.135338345864662

Variable Format: numeric

Notes: UNF:6:k4oC+ISl3sDuqYzCXMBCPw==

CancerType

f4822552 Location:

Summary Statistics: Max. 9.0; Mean 3.180451127819548; Min. 1.0; Valid 133.0; StDev 1.9378001682091968

Variable Format: numeric

Notes: UNF:6:T6NI+baTIOeTl31ET7duHA==

WBCResultStart(THOU/uL)

f4822552 Location:

Summary Statistics: StDev 121.28087357752649; Min. 0.85; Max. 999.0; Valid 133.0; Mean 21.56834586466165

Variable Format: numeric

Notes: UNF:6:/ZaIdbCGXDQMeyK+s7GxXA==

WBCResultEnd(THOU/uL)

f4822552 Location:

Summary Statistics: Valid 133.0; Max. 999.0; Min. 2.27; StDev 121.32517824076665; Mean 21.20518796992481

Variable Format: numeric

Notes: UNF:6:JvfT6jKIL0tf3h4RYi8GAQ==

HematocritResultStart(%)

f4822552 Location:

Summary Statistics: Max. 999.0; StDev 117.72180772729365; Min. 27.0; Valid 133.0; Mean 50.30075187969927;

Variable Format: numeric

Notes: UNF:6:XtxWCw5WzRbba1lQTlXUeA==

HematocritResultEnd(%)

f4822552 Location:

Summary Statistics: Mean 49.63157894736841; Valid 133.0; Min. 26.0; StDev 117.81775048161735; Max. 999.0;

Variable Format: numeric

Notes: UNF:6:Nm6+PfVI2qVz0vqNSjOzxw==

InPatient

f4822552 Location:

Summary Statistics: StDev 121.93872957674535; Mean 16.323308270676698; Valid 133.0; Max. 999.0; Min. 0.0;

Variable Format: numeric

Notes: UNF:6:NbIpW8byRP5sp2pEV6rhqw==

OutPatient

f4822552 Location:

Summary Statistics: Max. 999.0; Min. 17.0; Valid 133.0; Mean 64.70676691729325; StDev 117.07656015919845;

Variable Format: numeric

Notes: UNF:6:TOGmQ6hE3Lgw2tlGMU7s4w==

Note

f4822552 Location:

Variable Format: character

Notes: UNF:6:8g1eFJd9OZAaBFOJOZvzNA==

stcode

f4822554 Location:

Summary Statistics: Mean 6998.5607476635505; Min. 6016.0; Max. 7257.0; Valid 214.0; StDev 359.95009246053706

Variable Format: numeric

Notes: UNF:6:0ngHogN95CNJs3atd820lA==

Consent

f4822554 Location:

Summary Statistics: Max. 1.0; Min. 1.0; StDev 0.0; Mean 1.0; Valid 214.0;

Variable Format: numeric

Notes: UNF:6:UqFZX8QnIP8absXa6wk/pg==

Gender

f4822554 Location:

Summary Statistics: StDev 0.46292020531982864; Mean 1.6915887850467288; Min. 1.0; Valid 214.0; Max. 2.0;

Variable Format: numeric

Notes: UNF:6:g0Up8CEzSOSiGfmGRSmobg==

Age

f4822554 Location:

Summary Statistics: Valid 214.0; StDev 10.809750626774377; Max. 77.0; Mean 52.46261682242991; Min. 23.0

Variable Format: numeric

Notes: UNF:6:GFpXW36v1cr3N2Z17sNiWQ==

Race

f4822554 Location:

Summary Statistics: Mean 2.1401869158878504; Max. 36.0; Min. 0.0; Valid 214.0; StDev 4.894086876004038;

Variable Format: numeric

Notes: UNF:6:vkSDurGeWDuBp5hjkyUMiQ==

Ethncty

f4822554 Location:

Summary Statistics: StDev 0.7131157482950518; Min. -1.0; Mean 0.7663551401869158; Valid 214.0; Max. 2.0

Variable Format: numeric

Notes: UNF:6:b28u8mqN533R4RjlkIItag==

Site

f4822554 Location:

Variable Format: character

Notes: UNF:6:ZA6HJr4/p+mYu7EBQSJDOA==

RegCmmnt

f4822554 Location:

Variable Format: character

Notes: UNF:6:WGyFmLvABu153mYBSPJJKg==

OffStdy

f4822554 Location:

Variable Format: character

Notes: UNF:6:AhoUkiOfBL8HOhSOWe3YCw==

DiseaseStage

f4822554 Location:

Summary Statistics: Valid 213.0; Max. 4.0; StDev 0.9895145197785179; Mean 3.1267605633802815; Min. 1.0

Variable Format: numeric

Notes: UNF:6:s8IhfLettvGCIi9IhZI7dg==

#PriorChemoRegiments(0,1,2ormore)

f4822554 Location:

Summary Statistics: Mean 0.4903225806451613; StDev 0.741775178033441; Valid 155.0; Min. 0.0; Max. 2.0

Variable Format: numeric

Notes: UNF:6:ICJPbRqnx4V7bq7YzYjyeg==

ResearchSite

f4822554 Location:

Variable Format: character

Notes: UNF:6:64qn8RrCxEYWnH/HtfMzng==

CancerType

f4822554 Location:

Variable Format: character

Notes: UNF:6:RkIkmE1APE0k4bzrttV7yw==

Other Study-Related Materials

Label:

A.C. Data Dictionary 1_Clinical Study.pdf

Text:

Code book 1 for complete data

Notes:

application/pdf

Other Study-Related Materials

Label:

A.C. Data Dictionary 2_Clinical Study.pdf

Text:

Code book 2 for complete data

Notes:

application/pdf

Other Study-Related Materials

Label:

Clinical Data Code Book_9-11-14.docx

Text:

Code book for fatigue scores file and SCCA data

Notes:

application/vnd.openxmlformats-officedocument.wordprocessingml.document