scholarly journals Educational interventions to improve quality of life in people with chronic inflammatory skin diseases: systematic reviews of clinical effectiveness and cost-effectiveness

2015 ◽  
Vol 19 (86) ◽  
pp. 1-176 ◽  
Author(s):  
Karen Pickett ◽  
Emma Loveman ◽  
Neelam Kalita ◽  
Geoff K Frampton ◽  
Jeremy Jones

BackgroundInflammatory skin diseases include a broad range of disorders. For some people, these conditions lead to psychological comorbidities and reduced quality of life (QoL). Patient education is recommended in the management of these conditions and may improve QoL.ObjectivesTo assess the clinical effectiveness and cost-effectiveness of educational interventions to improve health-related quality of life (HRQoL) in people with chronic inflammatory skin diseases.Data sourcesTwelve electronic bibliographic databases, including The Cochrane Library, MEDLINE and EMBASE, were searched to July 2014. Bibliographies of retrieved papers were searched and an Advisory Group contacted.Review methodsSystematic reviews were conducted following standard methodologies. Clinical effectiveness studies were included if they were undertaken in people with a chronic inflammatory skin condition. Educational interventions that aimed to, or could, improve HRQoL were eligible. Studies were required to measure HRQoL, and other outcomes such as disease severity were also included. Randomised controlled trials (RCTs) or controlled clinical trials were eligible. For the review of cost-effectiveness, studies were eligible if they were full economic evaluations, cost–consequence or cost analyses.ResultsSeven RCTs were included in the review of clinical effectiveness. Two RCTs focused on children with eczema and their carers. Five RCTs were in adults. Of these, two were of people with psoriasis, one was of people with acne and two were of people with a range of conditions. There were few similarities in the interventions (e.g. the delivery mode, the topics covered, the duration of the education), which precluded any quantitative synthesis. Follow-up ranged from 4 weeks to 12 months, samples sizes were generally small and, overall, the study quality was poor. There appeared to be positive effects on HRQoL in participants with psoriasis in one trial, but no difference between groups in another trial in which participants had less severe psoriasis. Carers of children in one RCT of eczema showed improvement in HRQoL; however, in a RCT evaluating a website intervention there were no demonstrable effects on HRQoL. Neither the RCT in those adults with acne nor the RCT in those adults with mixed skin conditions demonstrated an effect on HRQoL. One RCT reported subgroups with atopic dermatitis or psoriasis and education was effective for psoriasis only. Other outcomes also showed mixed results. It is unclear how clinically meaningful any of the observed improvements are. Three studies of cost-effectiveness were included. The interventions, comparators and populations varied across the studies and, overall, the studies provided limited information on cost-effectiveness. The studies did provide detailed information on resources and costs that could be useful to inform a future cost-effectiveness evaluation in this area.LimitationsThe application of the inclusion criterion around whether the interventions were aimed at improving HRQoL or the inference that they could improve HRQoL was difficult as information was rarely reported.ConclusionsThere is uncertainty regarding whether educational interventions addressing issues that could improve HRQoL in people with chronic skin conditions are effective. Tentative conclusions about the best approach to delivering these kinds of interventions are that face-to-face, group, sessions may be beneficial; however, text messages may also be effective. Delivery over a period of time and by a multidisciplinary team may also be associated with positive outcomes. There is uncertainty over whether or not educational interventions are cost-effective.Study registrationThis study is registered as PROSPERO CRD42014007426.FundingThe National Institute for Health Research Health Technology Assessment programme.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Kristin Helene Skullerud ◽  
Petter Gjersvik ◽  
Are Hugo Pripp ◽  
Erik Qvigstad ◽  
Anne Lise Ording Helgesen

Abstract Background Genital erosive lichen planus (GELP) is a genital subtype of lichen planus, a chronic autoimmune inflammatory disease of unknown aetiology. In women, GELP is characterised by painful vulvo-vaginal mucosal erosions and scarring, often resulting in poor sexual health and reduced quality of life. Treatment options are limited and often with little effect. Apremilast, a phosphodiesterase 4-inhibitor, has been shown to have a positive effect on psoriasis and other inflammatory skin diseases. We aim to investigate the effect and safety of peroral apremilast in women with GELP in a randomised placebo-controlled double-blinded clinical trial. Methods We will recruit 42 adult women with characteristic clinical and/or histological features of moderate-to-severe GELP from a specialised vulva clinic in Oslo, Norway. The patients will be randomised 1:1 to either apremilast 30 mg BID (with an initial dose titration on days 1–6) or a placebo for 24 weeks. The concomitant use of topical corticosteroids will be allowed. The primary end point will be the mean GELP score, a clinical scoring system, at week 24 in the apremilast-treated patients versus the placebo-treated patients. The secondary end points will include the mean GELP score improvement from weeks 0 to 24, patient-reported use of topical steroids, the pain score on a visual analogue scale and the number of patients with GELP score improvements at weeks 16 and 24. The Physician Global Assessment , Patient Global Assessment and selected quality of life and sexual function assessments will be recorded at weeks 0, 16 and 24. The exploratory endpoints include description of immunohistochemical changes before and after apremilast therapy, assessed in vulvar or vaginal biopsies at weeks 0 and 24. Regular follow-ups for possible adverse events will be conducted. Discussion The study design is based on experience from studies on apremilast in other inflammatory skin diseases using equivalent apremilast doses for approved indications. The trial may provide evidence for the use of apremilast in women with this burdensome genital dermatosis. Trial registration ClinicalTrials.govNCT0365666. Registered on 4 September 2018.


2014 ◽  
Vol 5 ◽  
pp. 29-38 ◽  
Author(s):  
Matthias Augustin ◽  
Anna K. Langenbruch ◽  
Katharina Herberger ◽  
Katrin Baade ◽  
Lisa Goepel ◽  
...  

2015 ◽  
Vol 3 (14) ◽  
pp. 1-182 ◽  
Author(s):  
Mark Corbett ◽  
Morag Heirs ◽  
Micah Rose ◽  
Alison Smith ◽  
Lisa Stirk ◽  
...  

BackgroundRecent policy and guidance has focused on chemotherapy services being offered closer to home, but the clinical and economic implications of this are uncertain.ObjectivesTo compare the impact of delivering intravenous chemotherapy in different settings on a range of outcomes, including quality of life, safety and costs.DesignMultimethods approach: systematic review of clinical effectiveness, qualitative and cost-effectiveness studies; description of the patient pathway and brief survey of current provision; and development of a decision model to explore aspects of cost-effectiveness.SettingProvision of intravenous chemotherapy.ParticipantsChemotherapy patients.InterventionsSetting in which chemotherapy was administered (home, community or outpatient).Outcome measuresSafety, quality of life, preference, satisfaction, opinions/experiences, social functioning, clinical outcomes, costs and resource/organisational issues.Data sourcesSixteen electronic databases (including MEDLINE, EMBASE and The Cochrane Library) were searched from inception to October 2013 for published and unpublished studies.Review methodsTwo reviewers independently screened potentially relevant studies, extracted data and quality assessed the included studies. Study validity was evaluated using appropriate quality assessment tools. Clinical effectiveness and cost-effectiveness studies were summarised narratively, and qualitative studies were synthesised using meta-ethnography.ResultsOf the 67 eligible studies, 25 were comparative, with nine including a concurrent economic evaluation. Although some of the 10 randomised trials were designed to minimise avoidable biases, slow recruitment rates and non-participation of eligible patients for setting-related reasons meant that trial sample sizes were small and populations were inherently biased to favour the home or community settings. There was little evidence to suggest differences between settings in terms of quality of life, clinical outcomes, psychological outcomes or adverse events. All nine economic evaluations were judged as having low or uncertain quality, providing limited evidence to draw overall conclusions. Most were cost–consequence analyses, presenting cost outcomes alongside trial results but deriving no summary measure of benefit. Poor resource use reporting and use of different perspectives across settings made results difficult to compare. Seventeen qualitative studies (450 participants) were judged as moderate to good quality, although all compared new or proposed services with existing outpatient facilities and biased samples were used. The three main lines of argument were barriers to service provision, satisfaction with chemotherapy and making compromises to maintain normality. Most patients made explicit trade-offs between the time and energy required for outpatient chemotherapy, which reduced quality of life, and an increased sense of safety. A patient pathway was described, informed by expert advice and a brief survey of NHS and private providers, which identified wide variation in the ways in which home and community chemotherapy was delivered. Considering limitations of the available data and variation in provision, cost-effectiveness modelling results were not robust and were viewed as exploratory only; the results were highly unstable.ConclusionsPrimary studies comparing settings for administering intravenous chemotherapy appear difficult to conduct. Consequently, few robust conclusions can be made about the clinical effectiveness and cost-effectiveness. Qualitative studies indicate that the patient time and energy required for outpatient chemotherapy reduces quality of life. A nested randomised controlled trial within a larger observational cohort of patients is proposed to enhance recruitment and improve generalisability of results. Future economic evaluations require detailed patient characteristic, resource use, cost and quality-of-life data, although their results are likely to have limited generalisability.Study registrationThis study is registered as PROSPERO CRD42013004851.FundingThe National Institute for Health Research Health Services and Delivery Research programme.


2016 ◽  
Vol 20 (67) ◽  
pp. 1-178 ◽  
Author(s):  
Marie Westwood ◽  
Bram Ramaekers ◽  
Shona Lang ◽  
Nigel Armstrong ◽  
Caro Noake ◽  
...  

BackgroundAllergy is a form of immune-mediated exaggerated sensitivity (hypersensitivity) to a substance that is either inhaled, swallowed, injected or comes into contact with the skin. Foreign substances that provoke allergies are called allergens. It has been claimed that multiplex allergen testing may help in diagnosing the cause of symptoms in patients with an unclear cause of allergy or who are allergic to more than one substance.ObjectivesTo evaluate multiplex allergen testing [devices that can measure the presence of multiple immunoglobulin E (IgE) antibodies in a patient’s blood at the same time], by assessing (1) clinical effectiveness (allergy symptoms, incidence of acute exacerbations, mortality, adverse events of testing and treatment, health-care presentations or admissions, health-related quality of life); (2) effects on treatment (diet, immunotherapy medications, other potential testing); (3) any additional diagnostic information provided by multiplex allergen testing; and (4) cost-effectiveness (cost of different assessment strategies).MethodsFifteen databases were searched from 2005 to April 2015, including MEDLINE (via OvidSp), MEDLINE In-Process Citations, MEDLINE Daily Update, PubMed (National Library of Medicine), EMBASE, Cochrane Database of Systematic Reviews (CDSR), Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA) database, Science Citation Index (SCI), Conference Proceedings Citation Index-Science (CPCI-S), BIOSIS Previews, Latin American and Caribbean Health Sciences Literature (LILACS), National Institute for Health Research (NIHR) HTA programme, and the US Food and Drug Administration (FDA); supplementary searches of conference proceedings and trials registries were performed. Review methods followed published guidance from the Cochrane Collaboration and the Centre for Reviews and Dissemination, University of York, UK. The methodological quality of included studies was assessed using appropriate published tools or a review-specific tool designed by the project team. Studies were summarised in a narrative synthesis. Owing to a lack of data on the clinical effectiveness of multiplex allergen testing, no long-term cost-effectiveness model was developed. A conceptual model structure was developed and cost analyses were performed to examine the short-term costs of various possible diagnostic pathways.ResultsFifteen studies were included in the review. The very limited available data indicated that the addition of multiplex allergen testing [ImmunoCAP®Immuno Solid-phase Allergen Chip (ISAC), Thermo Fisher Scientific/Phadia AB, Uppsala, Sweden] to standard diagnostic work-up can change the clinicians’ views on the diagnosis, management and treatment of patients. There was some indication that the use of ImmunoCAP ISAC testing may be useful to guide decisions on the discontinuation of restrictive diets, the content of allergen-specific immunotherapy (SIT) prescriptions, and whether or not patients should receive SIT. However, none of the studies that we identified reported any information on clinical outcomes subsequent to changes in treatment or management. There was some evidence that ImmunoCAP ISAC may be useful for discriminating allergens that are structurally similar and are recognised by the same IgE antibody (cross-immunoreactive). No data were available for Microtest (Microtest Matrices Ltd, London, UK). Detailed cost analyses suggested that multiplex allergen testing would have to result in a substantial reduction of the proportions of patients receiving single IgE testing and oral food challenge tests in order to be cost-saving in the short term.ConclusionsNo recommendations for service provision can be made based on the analyses included in this report. It is suggested that a consensus-based protocol for the use of multiplex allergen testing be developed. The clinical effectiveness and cost-effectiveness of the proposed protocol should then be assessed by comparing long-term clinical and quality of life outcomes and resource use in patients managed using the protocol with those managed using a standard diagnostic pathway.Study registrationThis study is registered as PROSPERO CRD42015019739.FundingThis project was a Diagnostic Assessment Report commissioned by the NIHR HTA programme on behalf of the National Institute for Health and Care Excellence.


2021 ◽  
Vol 12 ◽  
Author(s):  
Jingni Wu ◽  
Zhixiao Fang ◽  
Teng Liu ◽  
Wei Hu ◽  
Yangjun Wu ◽  
...  

Inflammatory skin diseases are induced by disorders of the host defense system of the skin, which is composed of a barrier, innate and acquired immunity, as well as the cutaneous microbiome. These disorders are characterized by recurrent cutaneous lesions and intense itch, which seriously affecting life quality of people across all ages and ethnicities. To elucidate molecular factors for typical inflammatory skin diseases (such as psoriasis and atopic dermatitis), transcriptomic profiling assays have been largely performed. Additionally, single-cell RNA sequencing (scRNA-seq) as well as spatial transcriptomic profiling have revealed multiple potential translational targets and offered guides to improve diagnosis and treatment strategies for inflammatory skin diseases. High-throughput transcriptomics data has shown unprecedented power to disclose the complex pathophysiology of inflammatory skin diseases. Here, we will summarize discoveries from transcriptomics data and discuss how to maximize the transcriptomics data to propel the development of diagnostic biomarkers and therapeutic targets in inflammatory skin diseases.


2021 ◽  
Vol 22 (7) ◽  
pp. 3679
Author(s):  
Charlotte M. Beddoes ◽  
Denise E. Rensen ◽  
Gert S. Gooris ◽  
Marc Malfois ◽  
Joke A. Bouwstra

The skin’s barrier ability is an essential function for terrestrial survival, which is controlled by intercellular lipids within the stratum corneum (SC) layer. In this barrier, free fatty acids (FFAs) are an important lipid class. As seen in inflammatory skin diseases, when the lipid chain length is reduced, a reduction in the barrier’s performance is observed. In this study, we have investigated the contributing effects of various FFA chain lengths on the lamellar phase, lateral packing. The repeat distance of the lamellar phase increased with FFA chain length (C20–C28), while shorter FFAs (C16 to C18) had the opposite behaviour. While the lateral packing was affected, the orthorhombic to hexagonal to fluid phase transitions were not affected by the FFA chain length. Porcine SC lipid composition mimicking model was then used to investigate the proportional effect of shorter FFA C16, up to 50% content of the total FFA mixture. At this level, no difference in the overall lamellar phases and lateral packing was observed, while a significant increase in the water permeability was detected. Our results demonstrate a FFA C16 threshold that must be exceeded before the structure and barrier function of the long periodicity phase (LPP) is affected. These results are important to understand the lipid behaviour in this unique LPP structure as well as for the understanding, treatment, and development of inflammatory skin conditions.


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