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Updating the diagnosis and classification of rosacea

Updating the diagnosis and classification of rosacea. Recommendations from the global ROSacea COnsensus (ROSCO) panel. What is rosacea?. A chronic inflammatory skin condition that predominantly affects the central area of the face

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Updating the diagnosis and classification of rosacea

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  1. Updating the diagnosis and classification of rosacea Recommendations from the global ROSaceaCOnsensus (ROSCO) panel

  2. What is rosacea? 1. van ZuurenEJ, et al.Cochrane database Syst Rev 2015; 4:CD003262. A chronic inflammatory skin condition that predominantly affects the central area of the face No official or universally accepted definition,1 but comprises a combination of characteristic major features:

  3. Current diagnostic practice according to 2002 NRS recommendations Primary diagnostic criteria (≥1) Secondary features (occurring independently or with primary features) Phymatous changes Burning or stinging sensations Erythematous plaques Facial dryness and scaling Oedema Peripheral location Ocular signs/symptoms • Transient erythema • Persistent erythema • Inflammatory papules/pustules • Telangiectasia NRS, National Rosacea Society. Wilkin J, et al.J Am AcadDermatol 2002; 46:584–7.

  4. Potential overlap of rosacea features with subtype classification ETR PPR Phymatous Ocular Facial erythema (transient and persistent) Telangiectasia Inflammatory papules/pustules Phymatous changes Ocular manifestations ETR, erythematotelangiectatic rosacea; PPR, papulopustular rosacea; NRS, National Rosacea Society. 1. WeinkleAP, et al.ClinCosmetInvestigDermatol 2015; 8:159–77. 2. Tan J, et al.Br J Dermatol 2013; 169:555–62. Patients with rosacea often present with a range of features that span multiple NRS subtypes, or progress between them1,2

  5. Transitioning from subtypes to phenotypes • Rosacea presentation may be more accurately defined as “phenotype”, since features can span multiple subtypes or progress between them,1–3 • Subtype classification may not fully cover the full range of clinical presentations and confound severity assessment • A phenotype-based approach would address rosacea and its treatment in a manner more consistent with the patient’s individual experience • phenotype /ˈfiːnə(ʊ)tʌɪp/ n. an individual’s observable characteristics that can be influenced by genetic or environmental factors.4 “As a provisional standard classification system, [the subtype classification] is likely to require modification in the future as the pathogenesis and subtypes of rosacea become clearer, and as its relevance and applicability are tested by investigators and clinicians.” – NRS, 20025 NRS, National Rosacea Society. 1. Powell FC. N Engl J Med 2005; 352:793–803. 2. Weinkle AP, et al.ClinCosmetInvestigDermatol 2015; 8:159–77. 3. Tan J, et al.Br J Dermatol 2013; 169:555–62. 4. National Human Genome Research Institute. Available at: http://www.genome.gov/glossary/index.cfm?id=152. Accessed 21 March 2016; 5. Wilkin J, et al.J Am AcadDermatol 2002; 46:584–7.

  6. Measuring rosacea severity • A variety of scales are used to measure rosacea severity1 • Some are repurposed from other disease areas • Larger-scale studies and validated scales are required for accurate and consistent severity measurement of individual features2 • The greatest value is likely to be in objective, practical tools to: • Set treatment targets • Monitor treatment progress Existing severity scales for rosacea clinical features CEA, Clinician’s Erythema Assessment; FAST, Flushing Asessment Tool; GFSS, Global Flushing Severity Score; IGA, Investigator’s Global Assessment; PSA, Patient’s Self-Assessment. 1. Hopkinson D, et al. J Am AcadDermatol 2015; 73:138–43.e4. 2. Van Zuuren EJ, et al.Cochrane database Syst Rev 2015; 4:CD003262.

  7. Psychosocial burden assessment • The patient burden of rosacea can be significant1–4 • Updated scales are still required to assess the psychosocial burden of rosacea • Only 10% of Cochrane-review-eligible rosacea RCTs included quality-of-life assessments5 • Less than half of the remaining studies reported participant-assessed changes in severity and satisfaction associated with these changes5 • RosaQoL is the only rosacea-specific tool used to assess the psychosocial burden • A 21-item scale6 • Does not cover all clinical features (e.g. phyma)6 • May have limited use in clinical practice RCT, randomised controlled trial. 1. CresceND, et al. J Drugs Dermatol 2014; 13:692–7; 2. AksoyB, et al.Br J Dermatol 2010; 163:719–25; 3. Su D, Drummond PD. ClinPsycholPsychother 2012; 19:488–95; 4. DirschkaT, et al.DermatolTher (Heidelb) 2015; 5:117–27; 5. Van Zuuren EJ, et al.Cochrane database Syst Rev 2015; 4:CD003262; 6. Nicholson K, et al.J Am AcadDermatol 2007; 57:213–21.

  8. About ROSCO: An international consensus project Expert panel Objectives To gain expert opinion and reach consensus on diagnosis and classification of rosacea To begin the development of a scale/grading system for physical and psychological features of rosacea To provide guidance on local/national adaptation • 17 dermatologists from Argentina, Brazil, Canada, China, France, Germany, India, Ireland, the Netherlands, Singapore, South Africa, the UK and the USA • 3 ophthalmologists from Germany (n=1) and the USA (n=2) • Process overseen by two chairpersons, who were involved in panel selection and Delphi design

  9. Methods | Modified Delphi process • All dermatologists completed the surveys and contributed at the meeting • Not all panellists answered all questions • All ophthalmologists completed the ocular surveys • In addition, one participated at the meeting ROSCO panel 17 dermatologists 3 ophthalmologists Dr Mark Mannisonly Dermatologye-survey 1 Ophthalmology e-survey 1 Dermatology e-survey 2 Ophthalmology e-survey 2 Dermatology e-survey 3 Face-to-face meeting

  10. Methods | Modified Delphi process (continued) Questionnaire development and administration • Consensus statements assessed level of agreement as ‘strongly disagree’, ‘disagree’, ‘agree’ or ‘strongly agree’ • Consensus: ≥75% ‘agree’ or ‘strongly agree’ • Some questions were open-ended to allow for the development of consensus statements in a subsequent round of voting Meeting process • Points without consensus at survey stage were discussed at the meeting • Panellists received an overview of each topic followed by workshop exercises on rosacea diagnosis, classification, severity and psychosocial burden • After each workshop, consensus statements were constructed and voted on • Voting was conducted by keypads and panellists were blinded to individual votes • If consensus was not reached, panellists discussed, refined the statement, and re-voted

  11. Results | Diagnosis and classification • Diagnostic, major and secondary features of rosacea *Associated with periodic intensification by potential trigger factors. The central facial location of signs and symptoms is essential for the diagnosis of rosacea (17/18) The bilateral facial location of signs and symptoms is typical, but not essential, for the diagnosis of rosacea (15/17)

  12. Discussion | Diagnosis and classification • Considerations, diagnostic requirements and exclusions for particular rosacea features *The presence of comedones may not exclude a diagnosis of rosacea since acne and rosacea may overlap in some patients. If flushing, inflammatory papules/pustules, telangiectasia or ocular manifestations are present, the addition of any other major feature could be diagnostic of rosacea

  13. Discussion | Diagnosis and classification • There are difficulties with diagnosing rosacea in darker skin types: • Erythema and telangiectasia may not be visible in skin phototypes V and VI • This may be overcome with experience and appropriate history-taking (e.g. greater emphasis on hyperpigmentation and symptoms of irritation, such as burning and stinging) • Other techniques, including skin biopsy can be considered

  14. Results | Severity scales • The severity of each sign or symptom should be rated independently rather than grouped into subtype (14/18), e.g.: • Rosacea with mild persistent erythema and moderate inflammatory papules/pustules • Rosacea with moderate flushing and severe phymatous changes • Effective and validated scales are required in rosacea to help clinicians assess the severity of individual signs and symptoms in an objective manner (14/18) • Cutaneous signs and symptoms of rosacea should be evaluated based on a categorical scale (17/18) • Rosacea sign/symptom severity should be assessed using a 5-point categorical scale with the following categories (18/18): • Clear/none • Almost clear/minimal • Mild • Moderate • Severe

  15. Results | Severity scales • Proposed severity scale dimensions *A number of panellists also considered photographs essential to assess severity of phymatous changes, together with changes related to age.

  16. Discussion | Severity scales • Rosacea can vary in intensity through a natural cycle, which should be considered when a history is taken • The timing of assessment should be reflective of a patient’s true severity levels (i.e. in the absence of trigger factors as far as is possible) • There is potential for an overall rosacea grading score • However, scales for each phenotype may not be relevant for every patient • It is also important to consider patients with darker skin phototypes • A patient-rated scale to capture the intensity of their symptoms should be considered for clinical practice • Subsequent development of these scales are planned

  17. Results | Psychosocial burden The psychosocial comorbidities of living with rosacea can adversely impact an individual’s well-being (17/18) The level of psychological burden of rosacea should influence treatment decisions (17/18) Physicians should routinely enquire about the psychosocial comorbidities of rosacea (16/16) The development of a practical tool to measure psychosocial comorbidities for patients who live with rosacea is needed (17/17) Research into psychosocial comorbidities for patients who live with rosacea warrants further investigation (15/15)

  18. Discussion | Psychosocial burden • More research is still needed into the major psychosocial comorbidities of rosacea • A new rosacea-specific psychosocial tool should: • Assess the psychosocial comorbidities for all major phenotypes (including rhinophyma, which is missing from the RosaQoL) • Consider comorbid conditions, including poor self-esteem, social isolation, depression and anxiety • Rosacea treatments are also associated with psychosocial comorbidities associated with rosacea treatments, e.g.: • Disheartenment due to overly high treatment expectations • The realisation that the requirement to reduce trigger factor exposure can lead to lifestyle limitations. • When determining the psychosocial comorbidities of rosacea, it is necessary and important to assess treatment expectations and burden • Patient-focused messages around psychosocial comorbidities can ensure successful management

  19. Results | Treatment goal-setting • Treatment goals in rosacea should be based on severity and psychosocial burden and should include: • Achieving clear/almost clear skin (15/17) • A reduction in severity of signs and symptoms (17/17) • A reduction in frequency of sign and symptom flares (17/17) • An improvement in patient-reported symptoms (visible and non-visible) (17/17) • Achieving patient satisfaction with treatment (17/17) • A reduction in the impact of rosacea on the patient (17/17) • The majority of panellists agreed that they would treat an individual phenotype when it bothered the patient, regardless of severity

  20. Results | Ocular features • Minimum combination of features diagnostic of ocular rosacea: Either: • lid margin telangiectasia and interpalpebralinjection Or: • Corneal findings/disease and scleral inflammation • Ocular features may present with or without skin disease Grading of ophthalmological abnormalities in ocular rosacea, based on clinical opinion of the ROSCO panel ophthalmologists Note: Since only three ophthalmologists were involved in the ROSCO project, the ocular rosacea outcomes may be less generalisable to all ophthalmologists than those relating to cutaneous features. The purpose of this section is to indicate current thinking amongst ophthalmologists regarding ocular rosacea, where at least two out of three panellists agreed on a statement, since ocular rosacea is considered a multi-disciplinary challenge.1 1. Odom RB. Cutis 2004; 73:9–14.

  21. Strengths and limitations of the project Strengths Limitations The majority of voting relied on clinical opinion and there may have been good evidence contradicting a particular statement Some think that the Delphi process is not necessarily ‘evidence-based’ and relies on clinical opinion1,7 However, the process is exploratory and well suited for issues which are difficult to define, expertise-specific and future-orientated, as in ROSCO8 Blinded voting and consideration of published evidence was used to overcome these concerns as far as possible • The Delphi process is increasingly used to develop treatment guidelines and recommendations, due to its systematic, democratic approach and scope for qualitative evidence assessment1–7 1. Armon K, et al. Arch Dis Child 2001; 85:132–42; 2. Behrens A, et al. Cornea 2006; 25:900–7; 3. Jefferson A, et al. PLoS One 2016; 11:e0146824; 4. Maxwell GP, et al. PlastReconstr surgery Glob open 2015; 3:e557; 5. Westby MD, et al. Arthritis Care Res (Hoboken) 2014; 66:411–23; 6. van de Velde CJH, et al. Eur J Cancer 2014; 50:1.e1–1.e34; 7. Jones J, Hunter D. BMJ 1995; 311:376–80; 8. Fletcher AJ, Marchildon GP. Int J Qual Methods 2014; 13:1–18.

  22. Conclusions Recommendations Implications ROSCO provides a global perspective on rosacea diagnosis and classification with representation from Africa, Asia, Europe, North/South America, which can be adapted for local guidelines The recommended updated approach is likely to improve management in all patients with rosacea by individualising therapy • A phenotype approach to rosacea diagnosis, severity grading and management • Patient-focused goal-setting • Development of a novel psychosocial tool to evaluate the burden of rosacea

  23. Adapting for local use • ROSCO is a global project and provides a basis for adaptation and development of local clinical practice guidelines • When adapting for local use, you may wish to consider: • Patient values/preferences • Local practice and healthcare structure • Access factors

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