Assessment tools for dermatological clinical studies

Assessment tools for dermatological clinical studies

clinical studies

Abstract:

Dermatological clinical studies need to be reported in a uniform pattern utilizing various authenticated assessment tools. A lack of knowledge regarding availability of study instruments for the assessment of the various dermatological conditions results in poor quality study reports. Here is a list of dermatological study questionnaires which can aid the researchers to assess the disease condition and the efficacy of treatment appropriately.

Keywords: Dermatological clinical studies, assessment tools, homoeopathy, quality of life questionnaires.

Abbreviations: World Health Organization quality of life scale (WHO-QOL), Visual analog scale- itch (VAS), Short-form 36 health survey (SF-36), EuroQOL dimension (EQ-5D), Marburg skin questionnaire (MHF), Children’s dermatology life quality index (CDLQI), Infant dermatology of life quality index (InToDermQoL), Quality of life index for atopic dermatitis (QoLIAD), Childhood atopic dermatitis impact scale (CADIS), Acne-specific quality of life questionnaire (Acne-QoL), Skin cancer index (SCI), Functional assessment of cancer therapy – melanoma (FACT-M), Chronic urticaria quality of life questionnaire (CU-2QoL), Body dysmorphic disorder questionnaire – dermatology version (BDDQDV), Dysmorphic concern questionnaire (DCQ), Body dysmorphic symptom scale (BDSS).

Introduction:

Clinical studies are the backbone of evidence based researches in medicine. These studies can range from a single case report to a large sample studies. A case report is the smallest publishable unit in the medical literature consisting of detailed presentation of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Whereas a case-series is an aggregation of several similar cases, consisting of minimum three cases.[1,2] Dermatological cases are very frequently reported as they are widespread  throughout the world and have wide variety of presentation and treatment options available. Homoeopathy as an alternative method of treatment has extensive scope in the treatment of dermatological conditions due to availability of wide range of medicines for the treatment of various dermatological conditions and it also lacks side effects.

Most of the dermatological cases treated with different methods of treatment lack uniformity while reporting. For evidence based and quality reporting of the cases, certain standard quality assessment scales need to be used for the assessment of the case studies. Photographic evidence usually suffice for case reports but cannot be used in larger size case series and other clinical studies. This creates a need for various assessment scales for the quality and standard reporting of the studies.

In the present era of evidence based medicine, a wide range of assessment tools are available depending on the type of study. Lack of information regarding availability of assessment scales leads to poor quality reporting of clinical studies. Here, a range of assessment scales for the reporting of dermatological clinical studies is being presented.

There are 4 types of instruments available for evaluation of the dermatological disorders [3,4,5]

  1. General quality of life questionnaires
  2. Dermatology specific quality of life questionnaires
  3. Disease-specific quality of life questionnaires
  4. Psychiatric effects of dermatological diseases questionnaires

The quality of life scales assesses impact of disease on quality of life of patient and deals with personal problems and need of the patient. General, dermatology specific, disease specific quality of life questionnaires are given under table 1, 2 and 3 respectively. Tools for assessment of psychiatric effects of dermatological disorders are given in table 4.

Table 1. General quality of life questionnaire’s [3,4,5]

Name of questionnaire Authored by
World Health Organization quality of life scale (WHO-QOL) World Health Organization
Visual Analog Scale- Itch (VAS) Phan NQ et al. 2012, Verweyen et al 2019
Short-form 36 health survey (SF-36) Bullinger 1995
Nottingham health profile Hunt et al 1985
EuroQOL dimension (EQ-5D) EuroQoL group, 1990
UK sickness impact profile Salek et al 1996
General health questionnaire Goldberg 1972

Table 2: Dermatology specific Quality of Life Scale [3,4,5]

Name of the questionnaire Authored by Additional information
Dermatology life quality index[6] Finlay and Khan 1994 Most frequently used. 110 translations have been done. In patients above 16 years of age. Consists of 10 questions.
Dermatology quality of life scales[7] Morgan et al 1997 17 psychosocial items and 12 activities items were assigned five–point scales
Dermatology specific quality of life questionnaire[8] Anderson 7 Rajgopalan 1997
Skindex-29 [9] Chren et al 1996 Original had 62-item which cannot be used. Skindex-29 is a revised 29-items version of Skindex. Skindex-16 is a single-page version of Skindex.
Marburg Skin Questionnaire (MHF) Stangier et al 1997 Marburger Hautfragebogen (MHF)
Children’s Dermatology Life Quality Index (CDLQI) Lewis-Jones and Finlay 1995 for children between 5 to 16 years of age
Infant Dermatology of Life Quality Index (InToDermQoL) Lewis Jones et al 2001 from birth to 4 years of age
Adjustment of Chronic Skin Disorders Stangier et al 2003
Skin Satisfaction Questionnaire Grolle et al 2003 an instrument for recording attitudes towards the skin in healthy persons and patients
Questionnaire on Experience with Skin Complaints Schmid – Ott et al 1996 especially for psoriasis and atopic dermatitis  

Table 3: Disease specific Quality of Scale [3,4,5]

Name of the questionnaire Authored by Disease condition
Quality of life index for atopic dermatitis (QoLIAD) [10] Whalley D et al 2004 Atopic dermatitis
Childhood atopic dermatitis impact scale (CADIS) [11] Chamlin S et al 2007 Atopic dermatitis in children
Cardiff acne disability index Salek et al 1997 Acne
Acne-specific quality of life questionnaire (Acne-QoL) [12] Girman CJ et al 2003 Acne
Skin cancer index (SCI) [13] Sanchez S et al 2019 Non melanoma skin cancer
Functional assessment of cancer therapy – melanoma (FACT-M) [14] Cormier J et al 2005 Melanoma
Psoriasis disability index Finlay & Kelly 1987 Psoriasis
Psoriasis life stress inventory Gupta and Gupta 1995 Psoriasis
Psoriasis specific measure of quality of life McKenna et al 2003 Psoriasis
Scalpdex [15] Chen et al 2002 Scalp disorders like scalp dermatitis, psoriasis, seborrheic dermatitis
Chronic urticaria quality of life questionnaire (CU-2QoL) [16] Baiardani I et al 2005 Chronic urticaria
Eczema disability index [17]   Salek M et al 1993 Eczema
Freiburg  quality  of  life  assessment [18] Augustin M et al 2010 Wounds
Dermatitis family impact scale Lawsen et al. 1998 Dermatitis
Acne disability index Motley and Finlay 1989 Acne
Atopic dermatitis Herd et al 1997 Atopic dermatits
Itching questionnaire Yosipovitch et al 2002 Itching
Leg ulcer questionnaire Hyland 1994 Leg ulcer
Melasma quality of life scale Balkrishnan et al 2003 Melasma
MIMIC questionnaire Leu 1985 Multidimensional especially psoriasis
MM module for melanoma Sigurdardotti et al 1993 Melanoma
Vespid allergy quality of life questionnaire Oude Elbrinke et al 2002 For allergies to bee and wasp stings

Table 4: Tools to assess psychiatric effects of dermatological disorders [5]

Name of the questionnaire Authored by
Body dysmorphic disorder questionnaire – dermatology version (BDDQDV) Danesh M et al 2015
Dysmorphic concern questionnaire (DCQ) Danesh M et al 2015
Body dysmorphic symptom scale (BDSS) Danesh M et al 2015

DLQI is the most frequently used questionnaire in dermatological studies. Other scales are used as per the requirement and feasibility of the study. Many other dermatological study instruments are also available but are less frequently used. Choice of the questionnaire depends on the type of study, applicability and availability of scale, requirements of the study, language in which the scale is available and population to be studied.

Discussion and conclusion:

A large number of questionnaires are available to the researchers and clinicians for different types of studies. There are disease specific scales available for different dermatological conditions. In conditions where specific scale for disease condition is not available, a general questionnaire or dermatology specific scales can be used as per the requirement of the researcher and his study. As most of the dermatological disorders affect the appearance of the patient and hence have an effect on the psychology of the patient, in such cases specific scales for assessing psychological effects of the dermatological condition are also available.

References:

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  • Anderson R, Rajagopalan R. Responsiveness of the Dermatology-specific Quality of Life (DSQL) instrument to treatment for acne vulgaris in a placebo-controlled clinical trial. Quality of Life Research [Internet]. 1998 [cited 30 June 2020];7(8):723-734. Available from: https://link.springer.com/article/10.1023/A:1008832917452
  • Chren M. Skindex [Internet]. Eprovide.mapi-trust.org. 1997 [cited 30 June 2020]. Available from: https://eprovide.mapi-trust.org/instruments/skindex
  • Whalley D, Mckenna S, Dewar A, Erdman R, Kohlmann T, Niero M et al. A new instrument for assessing quality of life in atopic dermatitis: international development of the Quality of Life Index for Atopic Dermatitis (QoLIAD). British Journal of Dermatology [Internet]. 2004 [cited 30 June 2020];150(2):274-283. Available from: https://pubmed.ncbi.nlm.nih.gov/14996098/
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  • Girman C, Lookingbell D, Thiboutot D, Johnson J, Light J, Hartmaier S et al. Acne-specific Quality of Life Questionnaire (Acne-QoL) Manual & Interpretation Guide [Internet]. Anzctr.org.au. 2003

. Available from: https://www.anzctr.org.au/Steps11and12/376709-(Uploaded-11-01-2019-20-05-40)-Study-related%20document.pdf

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About Author:

C. P. Sharma,

Principal, Bakson Homoeopathic Medical College & Hospital, Greater Noida

Arun Kumar

Assistant Professor, Department of Homoeopathic Pharmacy, Bakson Homoeopathic Medical College & Hospital, Greater Noida

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Homeopathy360 Team