Evidence map›Paper›PMID 36803647›Full record

Trial reportChest2023

Patient-Reported Symptom and Health-Related Quality-of-Life Validation and Responsiveness During the First 6 Months of Treatment for Mycobacterium avium Complex Pulmonary Disease.

Emily Henkle, Alexandra L Quittner, Nathan F Dieckmann, Heather Franklin, Amanda E Brunton, Charles L Daley, Kevin L Winthrop, MAC2v3 Investigators

Registry-linked trialOpen access · greenAbstract readRandomized Controlled TrialPragmatic Clinical Trial
In one paragraph

Trial report in Chest, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03672630 (Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.6field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03672630 phase2 / phase3completednot on this map

Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease

TypeinterventionalSponsorKevin WinthropRan2019 to 2026Enrolled474ConditionsMycobacterium Avium Complex, Nontuberculous Mycobacterium InfectionArmsAzithromycin, Ethambutol, Rifampin
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Intermittent versus Daily Therapy for NoncavitaryAnnals of the American Thoracic Society · 2025
    Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Toward better cures forClinical microbiology reviews · 2024
    Review
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Emily HenkleOHSU-PSU School of Public Health, Oregon Health & Science University, Portland, OR. Electronic address: henkle@ohsu.edu.
Alexandra L QuittnerBehavioral Health Systems Research, Miami, FL.
Nathan F DieckmannSchool of Nursing, Oregon Health & Science University, Portland, OR.
Heather FranklinSchool of Nursing, Oregon Health & Science University, Portland, OR.
Amanda E BruntonOHSU-PSU School of Public Health, Oregon Health & Science University, Portland, OR.
Charles L DaleyNational Jewish Health, Denver, and the School of Medicine, University of Colorado, Aurora, CO.
Kevin L WinthropOHSU-PSU School of Public Health, Oregon Health & Science University, Portland, OR; Division of Infectious Disease, School of Medicine, Oregon Health & Science University, Portland, OR.
MAC2v3 Investigators
Oregon Health & Science University · USBehavioral Health Systems · USNational Jewish Health · US

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
Evaluating patient-reported outcomes for pulmonary nontuberculous mycobacterial diseaseK01HL150275 · NHLBI · OREGON HEALTH & SCIENCE UNIVERSITY · PI HENKLE, EMILY M. · 2020 to 2022
$446k
NCATS NIH HHS UL1 TR002369NHLBI NIH HHS K01 HL150275
6 · The paper itself

Abstract

backgroundNontuberculous mycobacteria (NTM), predominately Mycobacterium avium complex (MAC), cause chronic pulmonary disease. Improvements in symptoms and health-related quality of life (HRQoL) are important treatment outcomes, but no validated patient-reported outcome (PRO) measure exists. RESEARCH QUESTION: What are the validity and responsiveness of the Quality of Life-Bronchiectasis (QOL-B) questionnaire respiratory symptoms scale and key HRQoL measures during the first 6 months of MAC pulmonary disease (MAC-PD) treatment? STUDY DESIGN AND

methodsComparison of Two- vs Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease (MAC2v3) is an ongoing randomized, multisite pragmatic clinical trial. Patients with MAC-PD were randomized to azithromycin-based two-drug or three-drug therapy; treatment groups were combined for this analysis. PROs were measured at baseline, 3 months, and 6 months. The QOL-B respiratory symptoms, vitality, physical functioning, health perceptions, and NTM symptom domain scores (on a scale of 0-100, with 100 being best) were analyzed separately. We performed psychometric and descriptive analyses in the population enrolled as of the time of analysis and calculated the minimal important difference (MID) using distribution-based methods. Finally, we evaluated responsiveness using paired t tests and latent growth curve analysis in the subset with longitudinal surveys completed by the time of analysis.

resultsThe baseline population included 228 patients, of whom 144 had completed longitudinal surveys. Patients predominately were female (82%) and had bronchiectasis (88%); 50% were 70 years of age or older. The respiratory symptoms domain showed good psychometric properties (no floor or ceiling effects; Cronbach's α, 0.85) and an MID of 6.4 to 6.9. Vitality and health perceptions domain scores performed similarly. Respiratory symptoms domain scores improved by 7.8 points (P < .0001) and 7.5 points (P < .0001), and the physical functioning domain score improved by 4.6 points (P < .003) and 4.2 points (P = .01) at 3 and 6 months, respectively. Latent growth curve analysis confirmed a nonlinear, statistically significant improvement in respiratory symptoms and physical functioning domain scores by 3 months.

interpretationThe QOL-B respiratory symptoms and physical functioning scales exhibited good psychometric properties in patients with MAC-PD. Respiratory symptoms scores improved beyond the MID by 3 months after treatment initiation. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03672630; URL: www. CLINICALTRIALS: gov.

Indexed as

BronchiectasisLung DiseasesMycobacterium avium-intracellulare InfectionFemaleHumansMaleMycobacterium avium ComplexNontuberculous MycobacteriaQuality of LifeMycobacterium avium complexpatient-reported outcome measures

Identifiers

PMID36803647
PMCPMC10329268
OpenAlexW4321019828

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.