Evidence map›Paper›PMID 30313076›Full record

ArticleMedicine2018

Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles: Study protocol.

Sang-Hoon Yoon, Haebeom Lee, Chan-Young Kwon, Damin Jeon, Hyunho Kim, Hee-Geun Jo, Aesook Shin, Younghee Yun, Jae-Uk Sul, Geon-Mok Lee and 2 more

Open access · goldAbstract read
In one paragraph

Article in Medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.9field-weighted citation impact, top 15% 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

5 citing papers in PubMed, 16 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. 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

12 authors at 5 institutions in 2 countries.

Sang-Hoon YoonChung-Yeon Medical Institute.
Haebeom LeeDepartment of Human Informatics of Korean Medicine, Interdisciplinary Programs, Kyung Hee University.
Chan-Young KwonChung-Yeon Medical Institute.
Damin JeonChung-Yeon Medical Institute.
Hyunho KimChung-Yeon Medical Institute.
Hee-Geun JoChung-Yeon Medical Institute.
Aesook ShinChung-Yeon Medical Institute.
Younghee YunChung-Yeon Medical Institute.
Jae-Uk SulChung-Yeon Medical Institute.
Geon-Mok LeeLee-Geonmok Wonli Korean Medicine Hospital, Seocho-gu, Seoul.
Jun-Hwan LeeClinical Medicine Division, Korea Institute of Oriental Medicine.
Jungtae LeemChung-Yeon Medical Institute.
Chungwoon University · KRDunsan Korean Medicine Hospital · KRKyung Hee University · KRDongshin University · KRKorea Institute of Oriental Medicine · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite the wide usage of miniscalpel-needles (MSNs), information about MSN treatment-related adverse events (AEs) is insufficient. As the definition of AE might vary among physicians, without an exact definition for pain and hemorrhage, it is difficult to provide accurate information about AEs in MSN treatment to physicians, researchers, and patients. The aim of our study is to reach a consensus about the items and definitions of AEs that should be included in the survey form for prospective observational multicenter studies to record MSN treatment-related AEs. We will especially focus on obtaining a consensus on the definition of pain and hemorrhage caused by MSN treatment.

methodsOur study protocol is composed of 6 steps. First, we will identify the aim of the study. Next, we will conduct a systematic review to investigate MSN treatment-related AEs reported till date in Korea. Third, we will conduct a pilot observational prospective single-center study on AEs in MSN treatment. We will develop a standardized case report form to record MSN treatment-related AEs, including the causality, severity, and details of the MSN procedure at every site. Next, based on the pilot study, the Delphi study questionnaire will be developed by a panel composed of 13 physicians. The Delphi study will have 4 rounds with open questions and 4-point Likert-scale closed questions. Through these rounds, we will develop a consensus about the items and definitions of AEs that should be included in the survey form for future multicenter studies about MSN treatment-related AEs. Following this, a face-to-face consensus meeting will be held for a final agreement of survey form. The final survey form will then be approved by the related academic society for dissemination. DISCUSSION: The aim of this protocol is to develop a survey form for future prospective observational multicenter studies on MSN treatment-related AEs. This protocol will present the research methodology for developing a survey form, which will improve consistency and reliability between MSN treatment studies. We believe that this protocol can evaluate the safety of MSN treatment.

trial registrationClinical Research Information Service: KCT0002849.

Indexed as

Delphi TechniquePhysiciansAcupuncture TherapyHumansPilot ProjectsProspective StudiesReproducibility of ResultsResearch Design

Identifiers

PMID30313076
PMCPMC6203508
OpenAlexW2897344298

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.