Evidence map›Paper›PMID 27424173›Full record

ArticleHealth and quality of life outcomes2016

Development of the chronic obstructive pulmonary disease morning symptom diary (COPD-MSD).

Gary Globe, Brooke Currie, Nancy Kline Leidy, Paul Jones, David Mannino, Fernando Martinez, Paul Klekotka, Sean O'Quinn, Niklas Karlsson, Ingela Wiklund

Abstract readValidation Study
In one paragraph

Article in Health and quality of life outcomes, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Frailty in COPD: Clinical Impact, Diagnosis, Biomarkers, and Management Strategies.International journal of chronic obstructive pulmonary disease · 2025
    Pooled it
  2. Pooled it
  3. Understanding data visualization techniques in qualitative studies used to develop and validate patient-reported outcome measures: a targeted literature review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Review
  4. The Relationship Between Morning Symptoms and the Risk of Future Exacerbations in COPD.International journal of chronic obstructive pulmonary disease · 2020
    Article
  5. Evaluation of the psychometric properties of the Early Morning Symptoms of COPD Instrument (EMSCI).International journal of chronic obstructive pulmonary disease · 2018
    Article
  6. Article
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

10 authors.

Gary GlobeAmgen, One Amgen Center Drive, Thousand Oaks, CA, 91320, USA. gglobe@amgen.com.
Brooke CurrieEvidera, Bethesda, Maryland, USA.
Nancy Kline LeidyEvidera, Bethesda, Maryland, USA.
Paul JonesInstitute of Infection and Immunity, St George's, University of London, London, UK.
David ManninoDepartment of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington, KY, USA.
Fernando MartinezJoan and Sandy Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA.
Paul KlekotkaEli Lilly, Indianapolis, IN, USA.
Sean O'QuinnAstraZeneca, Gaithersburg, MD, USA.
Niklas KarlssonAstraZeneca, Gothenburg, Sweden.
Ingela WiklundEvidera, Bethesda, Maryland, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe morning tends to be the most difficult time of day for many patients with chronic obstructive pulmonary disease (COPD) when symptoms can limit one's ability to perform even simple activities. Morning symptoms have been linked to higher levels of work absenteeism, thereby increasing the already substantial economic burden associated with COPD. A validated patient-reported outcome (PRO) instrument designed to capture morning symptoms will allow for a more comprehensive approach to the evaluation of treatment benefit in COPD clinical trials.

methodsA qualitative interview study was conducted among a sample of symptomatic adults with COPD. Concept elicitation interviews (n = 35) were conducted to identify COPD morning symptoms, followed by cognitive interviews (n = 21) to ensure patient comprehension of the items, instructions and response options of the draft COPD Morning Symptom Diary (COPD-MSD). All interview transcript data were coded using ATLAS.ti software for content analysis.

resultsMean age of the concept elicitation and cognitive interview sample was 65.0 years (±7.5) and 62.3 years (±8.3), respectively. The study sample represented the full range of COPD severity (Global Initiative for Chronic Lung Disease [GOLD] classifications I-IV) and included a mix of racial backgrounds, employment status and educational achievement. During the concept elicitation interviews, the three most frequently reported morning symptoms were shortness of breath (n = 35/35; 100 %), phlegm/mucus (n = 31/35; 88.6 %), and cough (n = 30/35; 85.7 %). A group of clinical and instrument development experts convened to review the concept elicitation data and develop the initial 32-item draft COPD-MSD. Cognitive interviews indicated subjects found the draft COPD-MSD to be comprehensive, clear, and easy to understand. The COPD-MSD underwent minor editorial revisions and streamlining based on cognitive interviews and input from the experts to yield the final 19-item daily diary.

conclusionsThis study supports the content validity of the new COPD-MSD and positions the diary for quantitative psychometric testing.

Indexed as

Medical RecordsPsychometricsAgedFemaleHumansMaleMiddle AgedPatientsPulmonary Disease, Chronic ObstructiveQualitative ResearchQuality of LifeReproducibility of ResultsSurveys and QuestionnairesCOPDCOPD-MSDMorningPatient-reported outcomeSymptoms

Identifiers

PMID27424173
PMCPMC4947344

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Registered trials

None linked

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.