Core Outcome Measures in Effectiveness Trials

Developing a generic Core Outcome Set for Medical Indications for Laser Treatments in Dermatology

General Information

Summary:
During the past decades, advancements and modifications in laser technology has further widened its scope and greatly expanded the cutaneous laser surgeon’s armamentarium to the point that is now considered the treatment of choice for numerous cutaneous disorders. Different types of lasers have facilitated the treatment from less typical to more common medical indications including vascular, pigmented or inflammatory lesions, tumours, scars, keloids and (pre)malignant conditions.

The diversity in devices and medical indications make clinical decision-making in the laser field challenging. The current evidence to guide medical indications for laser therapy originates from a small number of randomized controlled trials (RCTs). Given the variety of medical indications for laser treatment in dermatology today, the evidence for most of these skin conditions is sporadic at best, consisting largely of case reports and case series.
Besides, in laser research there is no uniformity in outcome reporting, treatment regimen and adverse events. Further, outcomes that are most important to patients and healthcare providers for example ‘patient experience’ and ‘health-related quality of life’, are still undetermined. The variation in outcome reporting in laser research is a serious threat to comparative effectiveness research as it limits the ability to compare, contrast and combine individual studies and draw meaningful conclusions and guidance to inform clinical practice.

Core domain and outcome measurement sets have been developed for several other common cutaneous indications, including atopic eczema, psoriasis, vascular malformations, vitiligo and nail psoriasis, but not for indications for laser therapies in clinical dermatology. Moreover, at this moment, no core outcome set is being developed for any uncommon skin disorders. With new laser treatment technologies regularly evolving and yielding several kinds of indications, there is an urgency of standardizing outcome reporting in this field of dermatology. Consideration of the totality of the research evidence is needed to accurately inform healthcare providers on the most effective laser treatments for various medical indications in dermatology.

Summarizing, there is currently no core outcome set (COS) relevant to research in medial indications for laser treatment in dermatology. With an international collaboration in laser research we will incorporate the opinions of patients, expert physicians in laser, and other key stakeholders aiming to develop a standardized set of generic outcomes. Objectives include first determining what should be measured and second, how it should be measured in skin laser treatments for medical indications.

Standardized research in laser treatment offers the benefit to make results comparable between different studies and to increase the power of systematic reviews for various medical indications in dermatology. This will eventually lead to an improvement of evidence-based healthcare decisions.

Contributors:
A.Wolkerstorfer, MD, PhD,
Dermatologist
Dept. Dermatology/ Netherlands Institute for Pigment Disorders
Academic Medical Centre, University of Amsterdam, The Netherlands
expertise in clinical dermatology, laser dermatology, clinical research,
clinical trial methodology, leading a systematic review and consensus methodology.

C. A.C. (Sanna) Prinsen, PhD
VU University Medical Center,
Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, The Netherlands
expertise in clinimetrics, Core Outcome Set development, outcomes research, systematic reviews of PROMs, clinical trial methodology, leading systematic reviews, experience in COS development and consensus methodology.

F.Fransen, MD, PhD student
Dept. Dermatology
University of Amsterdam, The Netherlands
Experience in clinical dermatology and clinical research

L. Hedelund, MD, PhD,
Dermatologist
Department of Dermatology, Aarhus University Hospital, Denmark
Expertise in clinical dermatology, laser dermatology, clinical research.

H. Laubach, MD
Dermatologist
President of the European Society of Laser Dermatology
Geneva University Hospitals (HUG), Switzerland
Expertise in clinical dermatology, laser dermatology, clinical research, development of energy based devices and translational research.

L. Marini, M.D
Professor in laser dermatology, Chair EADV Task Force for Laser Dermatology
SDC - The Skin Doctors' Center, Trieste, Italy
Expertise in clinical dermatology, laser dermatology, clinical research.

M. Haedersdal, MD, PhD, DMSc
Professor, Consultant in dermatology
Visiting scientist, Wellman Center for Photomedicine
Massachusetts General Hospital, Harvard Medical School Boston, USA
University of Copenhagen, Bispebjerg Hospital, Denmark.
Expertise in clinical dermatology, laser dermatology, clinical research, systematic reviews, experimental translational research.

U. Paasch, MD, PhD
ÜBAG Professor dermatology, Germany
Expertise in clinical dermatology, laser dermatology, clinical research.

T. Passeron, MD, PhD
Professor in dermatology
University of Côte d'Azur, University Hospital Nice, Department of Dermatology, Nice, France
& INSERM U1065, team 12, C3M, Nice, France
Expertise in clinical dermatology, laser dermatology, clinical research.



Further Study Information

Current Stage:
Ongoing
Date:
February 2018 - February 2020
Funding source(s):
External funding EADV allocated to Dr. A. Wolkerstorfer, expert physician in skin laser surgery; Ongoing activities for funding opportunities

Health Area

Disease Category
Other
Skin

Disease Name
N/A

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Delphi process
Systematic review

The work will be organized and conducted in international collaboration between researchers, expert physicians, and other key stakeholders with various professional backgrounds. Extensive clinical expertise (medical and laser) is combined with expertise in the field of research methods (clinical research, qualitative research). This diversity in the experts’ backgrounds and expertise will embed the laser research within a broad perspective.

In a first step we will attain a comprehensive collection of reported outcomes in laser treatments for medical indications in dermatology. Based on these literature analyses, a Delphi study will be conducted.

After consensus on a COS for laser treatment, results of the previous literature analysis will be used to look for measurement instruments that meet the COS. In case that there is a need for further methodological development necessary projects will be set up.


Stakeholders Involved

Clinical experts
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice
Recommendations made for systematic reviews

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