Evidence map›Paper›PMID 29061190›Full record

ArticleTrials2017

Development of a core outcome set for clinical trials in basal cell carcinoma: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey.

Daniel I Schlessinger, Sanjana Iyengar, Arianna F Yanes, Jake M Lazaroff, Victoria Godinez-Puig, Brian R Chen, Anastasia O Kurta, Jill K Henley, Sarah G Chiren, Karina C Furlan and 7 more

Abstract read
In one paragraph

Article in Trials, 2017. 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. Pooled it
  2. Interventions for basal cell carcinoma of the skin.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Article
  4. Article
  5. Review
  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

17 authors.

Daniel I SchlessingerDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Sanjana IyengarDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Arianna F YanesDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Jake M LazaroffDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Victoria Godinez-PuigDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Brian R ChenDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Anastasia O KurtaDepartment of Dermatology, Saint Louis University School of Medicine, St. Louis, MO, USA.
Jill K HenleyDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Sarah G ChirenDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Karina C FurlanDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Jochen SchmittCentre for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.
Stefanie DeckertCentre for Evidence-Based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany.
Emily PoonDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA.
Joseph F SobankoDepartment of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Todd V CarteeDepartment of Dermatology, Penn State Hershey Dermatology, Hershey, PA, USA.
Murad AlamDepartment of Dermatology, Feinberg School of Medicine, Northwestern University, 676 N. St. Clair St., Ste 1600, Chicago, IL, 60611, USA. m-alam@northwestern.edu.
Ian A MaherDepartment of Dermatology, Saint Louis University School of Medicine, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBasal cell carcinoma is the most common skin cancer worldwide. Treatment options include both surgical and topical modalities. Although risk of metastasis is low, basal cell carcinoma can be invasive and infiltrate important underlying structures such as bone or cartilage. While many clinical trials examining therapies for basal cell carcinoma exist, the lack of consensus in outcome reporting across all trials poses a concern. Proper evaluation and comparison of treatment modalities is challenging. In order to address the inconsistencies present, this project aims to determine a core set of outcomes which should be evaluated in all clinical trials of basal cell carcinoma. METHODS/

designOutcomes will be extracted over four phases: (1) a systematic literature review, (2) patient interviews, (3) other published sources, and (4) stakeholder involvement. Potential outcomes will then be examined by the Steering Committee, who may add or remove outcomes. The Delphi process will then be performed to condense the list of outcomes generated. Two rounds of Delphi surveys will be performed with two groups of participants - physicians and patients. A consensus meeting with relevant stakeholders will be conducted after the Delphi exercise to further select outcomes, taking into account participant scores. By the end of the meeting, members will vote and decide on a final recommended set of core outcomes. For the duration of the study, we will be in collaboration with both the Core Outcome Measures in Effectiveness Trials (COMET) initiative and the Cochrane Skin Group - Core Outcome Set Initiative (CSG-COUSIN). DISCUSSION: This study aims to develop a core outcome set to guide assessment in clinical trials on basal cell carcinoma. The end-goal is to improve the consistency of outcome reporting and allow proper evaluation of treatment effectiveness.

Indexed as

Basal Cell CarcinomaClinical Trials as TopicEndpoint DeterminationOutcome Assessment, Health CareResearch DesignSkin NeoplasmsConsensusDelphi TechniqueHumansNeoplasm InvasivenessPatient ParticipationStakeholder ParticipationSystematic Reviews as TopicTreatment OutcomeBasal cell carcinomaConsensusCore outcome setDelphiStakeholdersSystematic review

Identifiers

PMID29061190
PMCPMC5654122

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.