Evidence map›Paper›PMID 34006542›Full record

ArticleBMJ open2021

Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15).

Yoshinobu Matsuda, Tatsuya Morita, Shunsuke Oyamada, Keisuke Ariyoshi, Takuhiro Yamaguchi, Satoru Iwase

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–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

1 citing paper in PubMed.

  1. 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

6 authors.

Yoshinobu MatsudaDepartment of Psychosomatic Internal Medicine, National Hospital Organisation Kinki-Chuo Chest Medical Center, Sakai, Japan matsuda.yoshinobu.tx@mail.hosp.go.jp.ORCID 0000-0001-5092-9377
Tatsuya MoritaPalliative and Supportive Care Division, Seirei Mikatahara Hospital, Hamamatsu, Japan.
Shunsuke OyamadaDepartment of Biostatictics, JORTC Data Center, Tokyo, Japan.
Keisuke AriyoshiDepartment of Data Management, JORTC Data Center, Tokyo, Japan.
Takuhiro YamaguchiDivision of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.
Satoru IwaseDepartment of Palliative Medicine, Saitama Medical University, Moroyama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionDyspnoea is common in patients with interstitial lung disease (ILD) and often refractory to conventional treatment. Little is known about the efficacy of systemic morphine for dyspnoea in patients with ILD. The aim of this study is to estimate the efficacy of a single subcutaneous morphine injection for dyspnoea in patients with ILD. METHODS AND ANALYSIS: We will conduct a multicentre, prospective, randomised, placebo-controlled, single-blinded phase II study of a single subcutaneous morphine injection for dyspnoea in patients with ILD. In patients with ILD who have dyspnoea at rest refractory to conventional treatment will be eligible for participation in this study. The morphine dose will be 2 mg. The primary endpoint is changes in dyspnoea intensity from baseline to 60 min after treatment as measured using an 11-point Numerical Rating Scale and compared between the morphine and placebo groups. ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Osaka City University Certified Review Board. The results of this study will be submitted for publication in an international peer-reviewed journal and the findings will be presented at international scientific conferences. TRIAL REGISTRATION NUMBER: jRCTs051190030; pre-results.

Indexed as

Lung Diseases, InterstitialMorphineClinical Trials, Phase II as TopicDouble-Blind MethodDyspneaHumansMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as TopicSingle-Blind MethodMorphineclinical trialsinterstitial lung diseasepalliative care

Identifiers

PMID34006542
PMCPMC8130746

What OpenQuestion holds

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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.