PMID- 36629737
OWN - NLM
STAT- MEDLINE
DCOM- 20230418
LR  - 20240416
IS  - 1535-4970 (Electronic)
IS  - 1073-449X (Print)
IS  - 1073-449X (Linking)
VI  - 207
IP  - 8
DP  - 2023 Apr 15
TI  - Minimal Clinically Important Difference in the 6-minute-walk Distance for 
      Patients with Pulmonary Arterial Hypertension.
PG  - 1070-1079
LID - 10.1164/rccm.202208-1547OC [doi]
AB  - Rationale: The 6-minute-walk distance (6MWD) is an important clinical and 
      research metric in pulmonary arterial hypertension (PAH); however, there is no 
      consensus about what minimal change in 6MWD is clinically significant. 
      Objectives: We aimed to determine the minimal clinically important difference in 
      the 6MWD. Methods: We performed a meta-analysis using individual participant data 
      from eight randomized clinical trials of therapy for PAH submitted to the U.S. 
      Food and Drug Administration to derive minimal clinically important differences 
      in the 6MWD. The estimates were externally validated using the Pulmonary 
      Hypertension Association Registry. We anchored the change in 6MWD to the change 
      in the Medical Outcomes Survey Short Form physical component score. Measurements 
      and Main Results: The derivation (clinical trial) and validation (Pulmonary 
      Hypertension Association Registry) samples were comprised of 2,404 and 537 adult 
      patients with PAH, respectively. The mean +/- standard deviation age of the 
      derivation sample was 50.5 +/- 15.2 years, and 1,849 (77%) were female, similar to 
      the validation sample. The minimal clinically important difference in the 
      derivation sample was 33 meters (95% confidence interval, 27-38), which was 
      almost identical to that in the validation sample (36 m [95% confidence interval, 
      29-43]). The minimal clinically important difference did not differ by age, sex, 
      race, pulmonary hypertension etiology, body mass index, use of background 
      therapy, or World Health Organization functional class. Conclusions: We estimated 
      a 6MWD minimal clinically important difference of approximately 33 meters for 
      adults with PAH. Our findings can be applied to the design of clinical trials of 
      therapies for PAH.
FAU - Moutchia, Jude
AU  - Moutchia J
AD  - Department of Biostatistics, Epidemiology, and Informatics and.
FAU - McClelland, Robyn L
AU  - McClelland RL
AD  - Department of Biostatistics, School of Public Health, University of Washington, 
      Seattle, Washington.
FAU - Al-Naamani, Nadine
AU  - Al-Naamani N
AD  - Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 
      Philadelphia, Pennsylvania.
FAU - Appleby, Dina H
AU  - Appleby DH
AD  - Department of Biostatistics, Epidemiology, and Informatics and.
FAU - Blank, Kristina
AU  - Blank K
AD  - Department of Biostatistics, School of Public Health, University of Washington, 
      Seattle, Washington.
FAU - Grinnan, Dan
AU  - Grinnan D
AD  - Department of Internal Medicine, Virginia Commonwealth University, Richmond, 
      Virginia.
FAU - Holmes, John H
AU  - Holmes JH
AD  - Department of Biostatistics, Epidemiology, and Informatics and.
FAU - Mathai, Stephen C
AU  - Mathai SC
AD  - Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.
FAU - Minhas, Jasleen
AU  - Minhas J
AUID- ORCID: 0000-0001-7864-6096
AD  - Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 
      Philadelphia, Pennsylvania.
FAU - Ventetuolo, Corey E
AU  - Ventetuolo CE
AD  - Departments of Medicine and Health Services, Policy and Practice, Brown 
      University, Providence, Rhode Island; and.
FAU - Zamanian, Roham T
AU  - Zamanian RT
AD  - Department of Medicine, School of Medicine, Stanford University, Palo Alto, 
      California.
FAU - Kawut, Steven M
AU  - Kawut SM
AD  - Department of Biostatistics, Epidemiology, and Informatics and.
AD  - Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 
      Philadelphia, Pennsylvania.
LA  - eng
GR  - T32 HL007891/HL/NHLBI NIH HHS/United States
GR  - K24 HL103844/HL/NHLBI NIH HHS/United States
GR  - K23 HL141584/HL/NHLBI NIH HHS/United States
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Respir Crit Care Med
JT  - American journal of respiratory and critical care medicine
JID - 9421642
SB  - IM
CIN - Am J Respir Crit Care Med. 2023 Apr 15;207(8):972-974. PMID: 36790379
MH  - Adult
MH  - Humans
MH  - Female
MH  - Middle Aged
MH  - Aged
MH  - Male
MH  - *Hypertension, Pulmonary/etiology
MH  - *Pulmonary Arterial Hypertension/complications
MH  - Minimal Clinically Important Difference
MH  - Familial Primary Pulmonary Hypertension/complications
MH  - Walking
PMC - PMC10112451
OTO - NOTNLM
OT  - PAH
OT  - individual participant data meta-analysis
OT  - minimum important difference
OT  - walk test
EDAT- 2023/01/12 06:00
MHDA- 2023/04/18 06:41
PMCR- 2024/04/15
CRDT- 2023/01/11 10:12
PHST- 2023/04/18 06:41 [medline]
PHST- 2023/01/12 06:00 [pubmed]
PHST- 2023/01/11 10:12 [entrez]
PHST- 2024/04/15 00:00 [pmc-release]
AID - 10.1164/rccm.202208-1547OC [doi]
PST - ppublish
SO  - Am J Respir Crit Care Med. 2023 Apr 15;207(8):1070-1079. doi: 
      10.1164/rccm.202208-1547OC.