Evidence map›Paper›PMID 25609942›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2015

Symptoms and impact of COPD assessed by an electronic diary in patients with moderate-to-severe COPD: psychometric results from the SHINE study.

Károly Kulich, Dorothy L Keininger, Brian Tiplady, Donald Banerji

Open access · goldAbstract readClinical Trial, Phase III
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
3.8field-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.

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

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Association between morning symptoms and physical activity in COPD: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2017
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Use of Ecological Momentary Assessment to Measure Dyspnea in COPD.International journal of chronic obstructive pulmonary disease · 2024
    Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. 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

4 authors at 2 institutions in 2 countries.

Károly KulichNovartis Pharma AG, Basel, Switzerland.
Dorothy L KeiningerNovartis Pharma AG, Basel, Switzerland.
Brian TipladyeResearch Technologies Ltd, Peterborough, UK.
Donald BanerjiNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Novartis (Switzerland) · CHTris Pharma (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSymptoms, particularly dyspnea, and activity limitation, have an impact on the health status and the ability to function normally in patients with chronic obstructive pulmonary disease (COPD).

methodsTo develop an electronic patient diary (eDiary), qualitative patient interviews were conducted from 2009 to 2010 to identify relevant symptoms and degree of bother due to symptoms. The eDiary was completed by a subset of 209 patients with moderate-to-severe COPD in the 26-week QVA149 SHINE study. Two morning assessments (since awakening and since the last assessment) and one evening assessment were made each day. Assessments covered five symptoms ("shortness of breath," "phlegm/mucus," "chest tightness," "wheezing," and "coughing") and two impact items ("bothered by COPD" and "difficulty with activities") and were scored on a 10-point numeric scale.

resultsPatient compliance with the eDiary was 90.4% at baseline and 81.3% at week 26. Correlations between shortness of breath and impact items were >0.95. Regression analysis showed that shortness of breath was a highly significant (P<0.0001) predictor of impact items. Exploratory factor analysis gave a single factor comprising all eDiary items, including both symptoms and impact items. Shortness of breath, the total score (including five symptoms and two impact items), and the five-item symptom score from the eDiary performed well, with good consistency and reliability. The eDiary showed good sensitivity to change, with a 0.6 points reduction in the symptoms scores (on a 0-10 point scale) representing a meaningful change.

conclusionThe eDiary was found to be valid, reliable, and responsive. The high correlations obtained between "shortness of breath" and the ratings of "bother" and "difficulty with activities" confirmed the relevance of this symptom in patients with COPD. Future studies will be required to explore further psychometric properties and their ability to differentiate between COPD treatments.

Indexed as

Health StatusPsychometricsSelf ReportActivities of Daily LivingAdultAgedAged, 80 and overBronchodilator AgentsCost of IllnessDyspneaFactor Analysis, StatisticalFemaleHumansLungMaleMiddle AgedBronchodilator Agentsdyspneahealth statuspatient-reported outcomespsychometric assessmentQVA149

Identifiers

PMID25609942
PMCPMC4293297
OpenAlexW2077049168

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.