PMID- 33947205
OWN - NLM
STAT- MEDLINE
DCOM- 20211015
LR  - 20220531
IS  - 1941-7705 (Electronic)
IS  - 1941-7713 (Print)
IS  - 1941-7713 (Linking)
VI  - 14
IP  - 5
DP  - 2021 May
TI  - Establishing Thresholds for Minimal Clinically Important Differences for the 
      Peripheral Artery Disease Questionnaire.
PG  - e007232
LID - 10.1161/CIRCOUTCOMES.120.007232 [doi]
AB  - BACKGROUND: Understanding minimum clinically important differences (MCID) in 
      patient-reported outcomes is essential in interpreting the magnitude of changes 
      in these measures. No MCID from patients' perspectives has ever been published 
      for peripheral artery disease-specific health status assessment tools. The 
      Peripheral Artery Questionnaire (PAQ) is a commonly used, validated peripheral 
      artery disease-specific health status instrument for which we sought to 
      prospectively establish its MCID from patients' perspectives. METHODS AND 
      RESULTS: Patients presenting to vascular clinics with new or worsened 
      claudication in the US cohort of the PORTRAIT (Patient-Centered Outcomes Related 
      to Treatment Practices in Peripheral Arterial Disease: Investigating 
      Trajectories) registry who completed baseline and follow-up PAQ assessments along 
      with the Global Assessment of Functioning scale were included. Mean change in PAQ 
      summary scores from 3- to 6-month follow-up was calculated according to Global 
      Assessment of Functioning category. MCID was defined as the mean difference in 
      scores between those with small improvement or deterioration and those with no 
      change. Multivariable linear regression was used to provide an MCID estimate 
      after adjusting for patients' 3-month PAQ score. Of the 483 patients who 
      completed the Global Assessment of Functioning score at 6 months and who had 
      available 3- and 6-month PAQ assessments, the mean age was 69 years, 42% were 
      female, and 71% were White. The MCIDs for PAQ summary scale improvement and 
      worsening were 8.7 (2.9-14.5) and -11.0 (-18.6 to -3.3), respectively. After 
      multivariable adjustment, these were 8.9 (3.0-14.8) and -11.2 (-18.2 to -4.2), 
      respectively. There was no significant interaction between treatment (invasive 
      versus noninvasive) and Global Assessment of Functioning response (P=0.75). 
      CONCLUSIONS: In patients with new or worsened claudication, a 10-point change in 
      PAQ summary score represents an MCID. This estimate needs external validation and 
      may inform the interpretation of PAQ scores when used as outcomes in clinical 
      trials or in routine clinical care. Registration: URL: 
      https://www.clinicaltrials.gov; Unique identifier: NCT01419080.
FAU - Peri-Okonny, Poghni A
AU  - Peri-Okonny PA
AD  - Department of Internal Medicine, University of Missouri, Kansas City (P.A.P.-O., 
      D.A., M.B., J.A.S.).
AD  - Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, 
      Kansas City, MO (P.A.P.-O., J.W., J.G., D.S, Y.T., M.B., J.A.S.).
FAU - Wang, Jingyan
AU  - Wang J
AD  - Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, 
      Kansas City, MO (P.A.P.-O., J.W., J.G., D.S, Y.T., M.B., J.A.S.).
FAU - Gosch, Kensey L
AU  - Gosch KL
FAU - Patel, Manesh R
AU  - Patel MR
AD  - Division of Cardiology, Duke University School of Medicine, Durham, NC (M.P.).
FAU - Shishehbor, Mehdi H
AU  - Shishehbor MH
AD  - Harrington Heart & Vascular Institute and Case Western University School of 
      Medicine, Cleveland, OH (M.H.S.).
FAU - Safley, David L
AU  - Safley DL
AD  - Department of Internal Medicine, University of Missouri, Kansas City (P.A.P.-O., 
      D.A., M.B., J.A.S.).
AD  - Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, 
      Kansas City, MO (P.A.P.-O., J.W., J.G., D.S, Y.T., M.B., J.A.S.).
FAU - Abbott, J Dawn
AU  - Abbott JD
AD  - Division of Cardiology, Department of Medicine, Brown University, Providence, RI 
      (J.D.A., H.D.A.).
FAU - Aronow, Herbert D
AU  - Aronow HD
AD  - Division of Cardiology, Department of Medicine, Brown University, Providence, RI 
      (J.D.A., H.D.A.).
FAU - Mena-Hurtado, Carlos
AU  - Mena-Hurtado C
AD  - Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, 
      Yale University, New Haven, CT (C.M.-H., Q.-U.-A.J., K.G.S.).
FAU - Jelani, Qurat-Ul-Ain
AU  - Jelani QU
AD  - Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, 
      Yale University, New Haven, CT (C.M.-H., Q.-U.-A.J., K.G.S.).
FAU - Tang, Yuanyuan
AU  - Tang Y
AD  - Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, 
      Kansas City, MO (P.A.P.-O., J.W., J.G., D.S, Y.T., M.B., J.A.S.).
FAU - Bunte, Matthew
AU  - Bunte M
AD  - Department of Internal Medicine, University of Missouri, Kansas City (P.A.P.-O., 
      D.A., M.B., J.A.S.).
AD  - Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, 
      Kansas City, MO (P.A.P.-O., J.W., J.G., D.S, Y.T., M.B., J.A.S.).
FAU - Labrosciano, Clementine
AU  - Labrosciano C
AD  - Department of Medicine, Queen Elisabeth Hospital, Adelaide, Australia (C.L., 
      J.F.B.).
FAU - Beltrame, John F
AU  - Beltrame JF
AD  - Department of Medicine, Queen Elisabeth Hospital, Adelaide, Australia (C.L., 
      J.F.B.).
FAU - Spertus, John A
AU  - Spertus JA
AD  - Department of Internal Medicine, University of Missouri, Kansas City (P.A.P.-O., 
      D.A., M.B., J.A.S.).
AD  - Department of Cardiovascular Medicine, Saint Luke's Mid America Heart Institute, 
      Kansas City, MO (P.A.P.-O., J.W., J.G., D.S, Y.T., M.B., J.A.S.).
FAU - Smolderen, Kim G
AU  - Smolderen KG
AD  - Vascular Medicine Outcomes (VAMOS) Program, Section of Cardiovascular Medicine, 
      Yale University, New Haven, CT (C.M.-H., Q.-U.-A.J., K.G.S.).
LA  - eng
SI  - ClinicalTrials.gov/NCT01419080
GR  - T32 HL110837/HL/NHLBI NIH HHS/United States
GR  - UL1 TR001863/TR/NCATS NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20210505
PL  - United States
TA  - Circ Cardiovasc Qual Outcomes
JT  - Circulation. Cardiovascular quality and outcomes
JID - 101489148
SB  - IM
MH  - Aged
MH  - Female
MH  - Humans
MH  - Intermittent Claudication/diagnosis/therapy
MH  - Minimal Clinically Important Difference
MH  - *Peripheral Arterial Disease/diagnosis/therapy
MH  - Quality of Life
MH  - Surveys and Questionnaires
PMC - PMC8254614
MID - NIHMS1715509
OTO - NOTNLM
OT  - health status
OT  - minimal clinically important difference
OT  - patients
OT  - quality of life
OT  - registries
EDAT- 2021/05/06 06:00
MHDA- 2021/10/16 06:00
PMCR- 2022/05/05
CRDT- 2021/05/05 05:30
PHST- 2021/05/06 06:00 [pubmed]
PHST- 2021/10/16 06:00 [medline]
PHST- 2021/05/05 05:30 [entrez]
PHST- 2022/05/05 00:00 [pmc-release]
AID - 10.1161/CIRCOUTCOMES.120.007232 [doi]
PST - ppublish
SO  - Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007232. doi: 
      10.1161/CIRCOUTCOMES.120.007232. Epub 2021 May 5.