Identifying and appraising patient-reported outcome measures on treatment satisfaction in acne: a systematic review.

BACKGROUND: After dermatitis, acne is the next skin disease to contribute most to the burden of skin diseases worldwide. Recently, seven core outcome domains have been identified, which together form an Acne Core Outcome Set (ACORN). One of these was satisfaction with acne treatment. OBJECTIVES: To identify studies that described the development of patient-reported outcome measures (PROMS), evaluated one or more measurement properties of a PROM, or evaluated the interpretability of a PROM in patients with acne regarding treatment satisfaction. METHODS: The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) search strategy for identifying PROMS on acne treatment satisfaction was used. We searched PubMed, MEDLINE, Embase, LILACS, Web of Science, Cochrane Library, Emcare, PsycINFO and Academic Search premier (June 2020). Study selection, data extraction and assessment of methodological quality according to COSMIN guidance were carried out independently by two authors. RESULTS: Only one study could be included, describing the development of a treatment satisfaction measure in patients with acne. The development was assessed as inadequate and data on measurement properties were lacking. Additionally, we found 188 studies reporting treatment satisfaction solely as an outcome, using a wide variety of methods, none of them standardized or validated. CONCLUSIONS: We could not find a PROM on treatment satisfaction to recommend for a core outcome set in acne. There is an unmet need for a PROM on treatment satisfaction in acne that is robustly developed, designed and validated.

Global Guidelines in Dermatology Mapping Project (GUIDEMAP): a scoping review of dermatology clinical practice guidelines.

BACKGROUND: Clinical practice guidelines (CPGs) play a critical role in standardizing and improving treatment outcomes based on the available evidence. It is unclear how many CPGs are available globally to assist clinicians in the management of patients with skin disease. OBJECTIVES: To search for and identify CPGs for dermatological conditions with the highest burden globally. METHODS: We adapted a list of 12 dermatological conditions with the highest burden from the Global Burden of Disease (GBD) study 2019. A systematic literature search was done to identify CPGs published between October 2014 to October 2019. The scoping review was conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) framework. RESULTS: A total of 226 CPGs were included. Melanoma had the greatest representation in the CPGs, followed by dermatitis and psoriasis. Skin cancers had a relatively high CPG representation but with lower GBD disease burden ranking. There was an uneven distribution by geographical region, with resource-poor settings being under-represented. The skin disease categories of the CPGs correlated weakly with the GBD disability-adjusted life-years metrics. Eighty-nine CPGs did not have funding disclosures and 34 CPGs were behind a paywall. CONCLUSIONS: The global production of dermatology CPGs showed wide variation in geographical representation, article accessibility and reporting of funding. The number of skin disease CPGs were not commensurate with its disease burden. Future work will critically appraise the methodology and quality of dermatology CPGs and lead to the production of an accessible online resource summarizing these findings.

Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel.

BACKGROUND: A transition from a subtyping to a phenotyping approach in rosacea is underway, allowing individual patient management according to presenting features instead of categorization by predefined subtypes. The ROSacea COnsensus (ROSCO) 2017 recommendations further support this transition and align with guidance from other working groups. OBJECTIVES: To update and extend previous global ROSCO recommendations in line with the latest research and continue supporting uptake of the phenotype approach in rosacea through clinical tool development. METHODS: Nineteen dermatologists and two ophthalmologists used a modified Delphi approach to reach consensus on statements pertaining to critical aspects of rosacea diagnosis, classification and management. Voting was electronic and blinded. RESULTS: Delphi statements on which the panel achieved consensus of ≥ 75% voting 'Agree' or 'Strongly agree' are presented. The panel recommends discussing disease burden with patients during consultations, using four questions to assist conversations. The primary treatment objective should be achievement of complete clearance, owing to previously established clinical benefits for patients. Cutaneous and ocular features are defined. Treatments have been reassessed in line with recent evidence and the prior treatment algorithm updated. Combination therapy is recommended to benefit patients with multiple features. Ongoing monitoring and dialogue should take place between physician and patients, covering defined factors to maximize outcomes. A prototype clinical tool (Rosacea Tracker) and patient case studies have been developed from consensus statements. CONCLUSIONS: The current survey updates previous recommendations as a basis for local guideline development and provides clinical tools to facilitate a phenotype approach in practice and improve rosacea patient management. What's already known about this topic? A transition to a phenotype approach in rosacea is underway and is being recommended by multiple working groups. New research has become available since the previous ROSCO consensus, necessitating an update and extension of recommendations. What does this study add? We offer updated global recommendations for clinical practice that account for recent research, to continue supporting the transition to a phenotype approach in rosacea. We present prototype clinical tools to facilitate use of the phenotype approach in practice and improve management of patients with rosacea.

Interventions for rosacea based on the phenotype approach: an updated systematic review including GRADE assessments.

BACKGROUND: Rosacea is a common chronic facial dermatosis. Classification of rosacea has evolved from subtyping to phenotyping. OBJECTIVES: To update our systematic review on interventions for rosacea. METHODS: We searched CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index and ongoing trials registers (March 2018) for randomized controlled trials. Study selection, data extraction, risk-of-bias assessment and analyses were carried out independently by two authors. Grading of Recommendations, Assessment, Development and Evaluations (GRADE) was used to assess certainty of evidence. RESULTS: We included 152 studies (46 were new), comprising 20 944 participants. Topical interventions included brimonidine, oxymetazoline, metronidazole, azelaic acid, ivermectin and other topical treatments. Systemic interventions included oral antibiotics, combinations with topical treatments or other systemic treatments. Several studies evaluated laser or light-based treatment. We present the most current evidence for rosacea management based on a phenotype-led approach. CONCLUSIONS: For reducing temporarily persistent erythema there was high-certainty evidence for topical brimonidine and moderate certainty for topical oxymetazoline; for erythema and mainly telangiectasia there was low-to-moderate-certainty evidence for laser and intense pulsed light therapy. For reducing papules/pustules there was high-certainty evidence for topical azelaic acid and topical ivermectin; moderate-to-high-certainty evidence for doxycycline 40 mg modified release (MR) and isotretinoin; and moderate-certainty evidence for topical metronidazole, and topical minocycline and oral minocycline being equally effective as doxycycline 40 mg MR. There was low-certainty evidence for tetracycline and low-dose minocycline. For ocular rosacea, there was moderate-certainty evidence that oral omega-3 fatty acids were effective and low-certainty evidence for ciclosporin ophthalmic emulsion and doxycycline.

Laser treatment of congenital melanocytic naevi: a systematic review.

Recent studies on congenital melanocytic naevi (CMN) indicate a lower risk of melanoma than has been previously assumed. As a result, the treatment paradigm in CMN has shifted from complete removal to cosmetically acceptable, less invasive treatment options, such as laser treatment. Our objective was to review systematically the efficacy and safety of laser therapy for CMN. We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PubMed. We rated the quality of evidence with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Twenty-four eligible studies (three nonrandomized controlled studies; 21 case series) with 434 patients were included; the majority were of poor quality). Twenty different laser modalities or combinations were evaluated. Overall, the Q-switched laser was used most frequently, although large or giant CMN were generally treated with an ablative laser. Owing to heterogeneity between studies, comparison between laser modalities was hampered and statistical analysis was precluded. Lasers in CMN showed rather good results (albeit with very low-quality evidence) for clearing of hyperpigmentation in the short term. Outcome measures varied widely, patient satisfaction was rarely measured and high incidences of scarring, repigmentation and complications were reported. No malignant change was seen. While most studies report short-term improvement of CMN after laser therapy, there is no high-quality evidence for the efficacy and safety of laser modalities in CMN in the long term. Future research should focus on well-conducted and well-reported prospective studies on different laser modalities for CMN, with the use of recognized and validated outcome measures.

Emollients and moisturizers for eczema: abridged Cochrane systematic review including GRADE assessments.

Eczema is a chronic inflammatory skin disorder with considerable impact on quality of life. Emollients or moisturizers are widely recommended, but are these effective and safe? We searched for randomized controlled trials (RCTs) in the Cochrane Skin Group Specialised Skin Register, CENTRAL in The Cochrane Library, MEDLINE, Embase, LILACS, the GREAT database and five trial registers to December 2015. We included 77 RCTs with 6603 participants. Seven studies (9%) were at low risk of bias, 34 (44%) had unclear risk and 36 (47%) were at high risk. The quality of the evidence was mainly low or moderate for the prespecified outcomes. The most important comparison, 'moisturizer vs. no moisturizer', showed improved Scoring Atopic Dermatitis values in the moisturizer group compared with no moisturizer [mean difference -2·42, 95% confidence interval (CI) -4·55 to -0·28], but did not meet the minimal important difference of 8·7. Fewer flares were seen (risk ratio 0·40, 95% CI 0·23-0·70) and the rate of flares was reduced (hazard ratio 3·74, 95% CI 1·86-7·50). The groups applying moisturizer used less topical corticosteroids over 6-8 weeks (mean difference -9·30 g, 95% CI 15·3 to -3·27). Glycyrrhetinic acid-, urea- and glycerol-containing creams worked better than their controls (vehicle, placebo or no moisturizer) according to both participants and physicians. More flares were reported with moisturizer alone than when combined with twice-weekly fluticasone propionate (risk ratio 2·17, 95% CI 1·55-3·11). Adding moisturizers to topical anti-inflammatory treatment was more effective than anti-inflammatory treatment alone and resulted in fewer flares.

AGREE II assessments of recent acne treatment guidelines: how well do they reveal trustworthiness as defined by the U.S. Institute of Medicine criteria?

BACKGROUND: Up-to-date, trustworthy guidelines are a widely relied upon means of promoting excellent patient care. OBJECTIVES: To determine the quality of recently published acne treatment guidelines by utilizing the Appraisal of Guidelines for Research and Evaluation (AGREE) II Reporting Checklist, the U.S. Institute of Medicine's (IOM) criteria of trustworthiness, the red flags of Lenzer et al. and CheckUp. METHODS: Systematic searches were conducted in bibliographic databases, guideline depositories and using Google to identify acne treatment guidelines published since 2013. Six assessors independently scored each guideline using the AGREE II Reporting Checklist. Guidelines were concomitantly assessed for trustworthiness using the IOM criteria and for the red flags of Lenzer et al., indicative of potential bias. Updates were screened using CheckUp. RESULTS: Eight guidelines were identified, two of which were updates. Lowest scoring AGREE II domains across all guidelines were applicability (six poor, one fair, one average) and rigour (four poor, one fair, three average). Two of the three highest-scoring guidelines were developed using AGREE II. No guideline fully met each IOM criterion and all raised at least one red flag indicative of potential bias. One updated guideline did not address seven of 16 items on CheckUp and the other did not address four. Patient involvement in guideline development was minimal. CONCLUSIONS: Use of the AGREE II instrument during guideline development did not have as great an effect on guideline quality as might be expected. There is considerable room for improvement in acne treatment guidelines in order to satisfy the IOM trustworthiness criteria and avoid bias.

Updating the diagnosis, classification and assessment of rosacea: recommendations from the global ROSacea COnsensus (ROSCO) panel.

BACKGROUND: Rosacea is currently diagnosed by consensus-defined primary and secondary features and managed by subtype. However, individual features (phenotypes) can span multiple subtypes, which has implications for clinical practice and research. Adopting a phenotype-led approach may facilitate patient-centred management. OBJECTIVES: To advance clinical practice by obtaining international consensus to establish a phenotype-led rosacea diagnosis and classification scheme with global representation. METHODS: Seventeen dermatologists and three ophthalmologists used a modified Delphi approach to reach consensus on statements pertaining to critical aspects of rosacea diagnosis, classification and severity evaluation. All voting was electronic and blinded. RESULTS: Consensus was achieved for transitioning to a phenotype-based approach to rosacea diagnosis and classification. The following two features were independently considered diagnostic for rosacea: (i) persistent, centrofacial erythema associated with periodic intensification; and (ii) phymatous changes. Flushing, telangiectasia, inflammatory lesions and ocular manifestations were not considered to be individually diagnostic. The panel reached agreement on dimensions for phenotype severity measures and established the importance of assessing the patient burden of rosacea. CONCLUSIONS: The panel recommended an approach for diagnosis and classification of rosacea based on disease phenotype.

Interventions for hirsutism excluding laser and photoepilation therapy alone: abridged Cochrane systematic review including GRADE assessments.

Hirsutism is a common disorder with a major impact on quality of life. The most frequent cause is polycystic ovary syndrome. Effects of interventions (except laser and light-based therapies) were evaluated, including Grading of Recommendations Assessment, Development and Evaluation assessments. Searches included Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, Medline, Embase and five trials registers to June 2014. We included 157 randomized controlled trials (RCTs) with 10 550 participants. The majority were assessed as having a 'high risk' of bias (123 of 157). The quality of evidence was rated moderate to very low for most outcomes. Pooled data for an oral contraceptive (OCP) (ethinyl oestradiol and cyproterone acetate) compared with another OCP (ethinyl oestradiol and desogestrel) demonstrated that both treatments were effective in reducing Ferriman-Gallwey scores, but the mean difference (MD) was not statistically significant [-1·84, 95% confidence interval (CI): -3·86-0·18]. Flutamide was more effective than placebo in two studies (MD -7·60, 95% CI: -10·53 to -4·67 and MD -7·20, 95% CI: -10·15 to -4·25), as was spironolactone (MD -7·69, 95% CI: -10·12 to -5·26). Spironolactone appeared to be as effective as flutamide (two studies) and finasteride (two studies). However, finasteride and the gonadotropin-releasing analogues showed discrepant results in several RCTs. Metformin was ineffective. Cyproterone acetate combined with OCPs demonstrated greater reductions in Ferriman-Gallwey scores. Lifestyle interventions reduced body mass index but did not show improvement in hirsutism, and although cosmetic measures are frequently used, no RCTs investigating cosmetic treatments were identified. RCTs investigating OCPs in combination with antiandrogens or finasteride vs. OCP alone, or the different antiandrogens and 5α-reductase inhibitors are warranted.

Shared decision making and patient decision aids in dermatology.

Shared decision making combines individual patient interests and values with clinical best evidence under the guiding principle of patient autonomy. Patient decision aids can support shared decision making and facilitate decisions that have multiple options with varying outcomes for which patients may attribute different values. Given the variable psychosocial impact of skin disease on individuals and relative uncertainty regarding best treatments and their adherence in many dermatological conditions, informed shared decision making, supported by patient decision aids, should constitute a central component of dermatological care.

Prevalence and odds of Staphylococcus aureus carriage in atopic dermatitis: a systematic review and meta-analysis.

BACKGROUND: Staphylococcus aureus is increasingly implicated as a possible causal factor in the pathogenesis of atopic dermatitis (AD). However, the reported prevalence rates of skin and nasal colonization in the literature vary widely. OBJECTIVES: This study evaluates the prevalence and odds of skin and nasal colonization with S. aureus in patients with AD. METHODS: A systematic literature search was conducted. Odds ratios (ORs) for colonization in patients vs. controls and the prevalence of colonization in patients were pooled using the random-effects model. RESULTS: Overall, 95 observational studies were included, of which 30 had a control group. The Newcastle-Ottawa Scale was used to assess study quality, with the majority of studies being of fair to poor quality. Patients with AD were more likely to be colonized with S. aureus than healthy controls [OR 19·74, 95% confidence interval (CI) 10·88-35·81]. Differences were smaller in nonlesional skin (OR 7·77, 95% CI 3·82-15·82) and in the nose (OR 4·50, 95% CI 3·00-6·75). The pooled prevalence of S. aureus colonization among patients was 70% for lesional skin, 39% for nonlesional skin and 62% for the nose. In lesional skin, meta-regression showed that the prevalence of colonization increased with disease severity. Study heterogeneity should be taken into consideration when interpreting the results. CONCLUSIONS: These results demonstrate the importance of colonization with S. aureus in AD. Further evaluation of the mechanisms by which S. aureus influences inflammation is required in addition to the development of targeted strategies to decrease skin and nasal S. aureus load.

A systematic review and meta-analysis on Staphylococcus aureus carriage in psoriasis, acne and rosacea.

Staphylococcus aureus might amplify symptoms in chronic inflammatory skin diseases. This study evaluates skin and mucosal colonization with S. aureus in patients with psoriasis, acne and rosacea. A systematic literature search was conducted. Both odds ratios (OR) for colonization in patients versus controls and the prevalence of colonization in patients are reported. Fifteen articles about psoriasis and 13 about acne (12 having a control group) were included. No study in rosacea met our inclusion criteria. For psoriasis, one study out of three controlled studies showed increased skin colonization (OR 18.86; 95 % confidence interval [CI] 2.20-161.99). Three out of the five studies that reported on nasal colonization showed significant ORs varying from 1.73 (95 % CI 1.16-2.58) to 14.64 (95 % CI 2.82-75.95). For acne one of the three studies that evaluated skin colonization reported a significant OR of 4.16 (95 % CI 1.74-9.94). A relation between nasal colonization and acne was not found. Limitations in study design and low sample sizes should be taken into consideration when interpreting the results. Colonisation with S. aureus seems to be increased in patients with psoriasis. This bacterial species, known for its potential to induce long-lasting inflammation, might be involved in psoriasis pathogenesis. Information on acne is limited. Prospective controlled studies should further investigate the role of S. aureus in chronic inflammatory skin diseases.

Alpine climate treatment of atopic dermatitis: a systematic review.

Climate therapy has been used for decades in the treatment of atopic dermatitis (AD), but evidence of its effectiveness has not yet been assessed systematically. A systematic literature search in Medline, Embase, and the Cochrane library was performed to identify all original studies concerning alpine climate treatment. The risk of bias of individual studies was assessed following the Cochrane Handbook, and level of evidence was rated using GRADE guidelines. Fifteen observational studies were included concerning 40 148 patients. Four studies concerning 2670 patients presented follow-up data over a period of 1 year. Disease activity decreased in the majority of patients during treatment (96% of n = 39 006) and 12-month follow-up (64% of n = 2670). Topical corticosteroid use could often be reduced or stopped during treatment (82% of n = 1178) and during 12-month follow-up (72% of n = 3008). Quality assessment showed serious study limitations, therefore resulting in a very low level of evidence for the described outcomes. Randomized controlled trials designed with a follow-up period including well-defined patient populations, detailed description and measurement of applied interventions during climate therapy and using validated outcomes including cost-effectiveness parameters, are required to improve the evidence for alpine climate therapy as an effective treatment for patients with AD.

Interventions for rosacea: abridged updated Cochrane systematic review including GRADE assessments.

Rosacea is a common chronic facial dermatosis. This update of our Cochrane review on interventions for rosacea summarizes the evidence, including Grading of Recommendations Assessment, Development and Evaluation (GRADE) Working Group assessments, of the effects of the currently available treatments. Searches included the following: Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, MEDLINE, EMBASE, LILACS and the Science Citation Index, and ongoing trials registries (July 2014). We included 106 randomized controlled trials (RCTs) with 13 631 participants, a more than 80% increase since the last update in 2011. Pooling of data was feasible for a few outcomes, for topical metronidazole and azelaic acid and both appeared to be more effective than placebo (moderate and high-quality evidence, respectively). Topical ivermectin was more effective than placebo based on two studies (high-quality evidence), and slightly more effective than metronidazole in one study. Brimonidine was more effective than vehicle in reducing erythema in rosacea (high-quality evidence). Ciclosporin ophthalmic emulsion was effective for ocular rosacea (low-quality evidence). For oral treatments there was moderate-quality evidence for the effectiveness of tetracycline based on two old studies, and high-quality evidence for doxycycline 40 mg compared with placebo according to physician assessments. One study at high risk of bias demonstrated equivalent effectiveness for azithromycin and doxycycline 100 mg. Minocycline 45 mg may be effective for papulopustular rosacea (low-quality evidence). Low-dose isotretinoin appeared to be slightly more effective than doxycycline 50-100 mg (high-quality evidence). Laser and light-based therapies for erythema in rosacea were effective (low-quality evidence). Further RCTs are required for ocular rosacea.

Evidence-based topical treatments for tinea cruris and tinea corporis: a summary of a Cochrane systematic review.

Tinea cruris and tinea corporis are common fungal infections. Most can be treated with a variety of topical antifungals. This review aimed to assess the evidence for the effectiveness and safety of topical treatments for tinea cruris and tinea corporis. Searches included the Cochrane Skin Group Specialised Register, CENTRAL in The Cochrane Library, Medline, Embase, LILACS and ongoing trials registries (August 2013). One hundred and twenty-nine randomized controlled trials (RCTs) with 18 086 participants evaluated a range of interventions - mostly azoles. Pooling of data for several outcomes was only possible for two individual treatments. In five studies, terbinafine showed a statistically significant higher clinical cure rate compared with placebo [risk ratio (RR) 4·51, 95% confidence interval (CI) 3·10-6·56]. Data for mycological cure could not be pooled owing to substantial heterogeneity. Across three studies, mycological cure rates favoured naftifine (1%) compared with placebo (RR 2·38, 95% CI 1·80-3·14) but the quality of the evidence was low. Combinations of azoles with corticosteroids were slightly more effective than azoles for clinical cure, but there was no statistically significant difference with regard to mycological cure. Sixty-five studies were assessed as 'unclear' and 64 as being at 'high risk' of bias; many were over 20 years old, and most were poorly designed and inadequately reported. Although most active interventions showed sufficient therapeutic effect, this review highlights the need for further, high-quality, adequately powered RCTs to evaluate the effects of these interventions, which can ultimately provide reliable evidence to inform clinical decision making.

Diphenylcyclopropenone in patients with alopecia areata. A critically appraised topic.

AIM: To assess the efficacy and safety of topical diphenylcyclopropenone (DPCP) in patients with alopecia areata. SETTING AND DESIGN: Study selection, data extraction, risk of bias assessment and analyses were carried out independently by two authors. The quality of evidence was rated with Grading of Recommendations Assessment, Development and Evaluation (GRADE). No randomised trials were identified, but 11 case series, conducted in dermatology departments in the Netherlands, UK, Iran, Italy, Egypt and Greece were included. STUDY EXPOSURE: Patients with mainly extensive and long-lasting alopecia totalis and universalis were treated. Most often one side of the scalp was treated with DPCP whilst the other side received no treatment. Treatment duration varied from 4 to 48 months with a follow up of 6 to 36 months. OUTCOMES: Outcomes included quality of life, patient satisfaction, adverse events, treatment effect and duration of remission. RESULTS: Eleven studies, with sample sizes of 18-139 comprising 500 patients, were retrieved. Our critical outcomes quality of life and patient satisfaction, were not or hardly addressed. In about half of the patients DPCP appeared to be effective, with transient side effects such as contact eczema, blistering, oedema of eyelids, headache and flu-like symptoms. If treatment was satisfactory the effect was maintained for more than a year. The overall quality of the evidence was rated very low. CONCLUSION: There is very low quality evidence for the effectiveness and safety in extensive resistant alopecia areata. Well-designed and well-conducted randomised controlled trials, with subsequent adequate reporting, including high-quality descriptions of all aspects of methodology are required.

Omalizumab in patients with chronic spontaneous urticaria: a systematic review and GRADE assessment.

Chronic spontaneous urticaria (CSU) is characterized by the occurrence of hives, angio-oedema or both for a period of at least 6 weeks. Many patients remain symptomatic despite treatment with H1 antihistamines, even at higher doses. This systematic review assessed the quality of the evidence for the effects of omalizumab as treatment in patients with CSU. We searched PubMed, the Cochrane Database of Systematic Reviews and the Cochrane Central Register of Controlled Trials up to 7 August 2014. Three review authors independently carried out study selection, risk of bias assessment and data extraction. Two review authors analysed the data. Five randomized controlled trials (RCTs), which included 1116 participants, were evaluated. All the RCTs were judged as having a low risk of bias. There was a statistically significant improvement in measures of disease activity and quality of life following treatment with omalizumab when compared with placebo [mean difference (MD) -11·58, 95% confidence interval (CI) -13·39 to -9·77 and MD -13·12, 95% CI -16·30 to -9·95, respectively]. Complete response and partial response were more frequent after treatment with omalizumab [risk ratio (RR) 6·44, 95% CI 3·95-10·49 and RR 4·08, 95% CI 2·98-5·60, respectively]. There was no difference in the proportion of participants reporting adverse events between the omalizumab and placebo treatment groups (RR 1·05, 95% CI 0·96-1·16). There was high-quality evidence to support the effectiveness and safety of omalizumab 300 mg per month for the treatment of CSU for up to 6 months.