Skin diseases affecting the vulva

Vulval skin disease is common in gynaecological practice. This article aims to enhance clinical skills in patient assessment, vulval examination and treatment of common benign vulval skin disease. Basic treatments are often of benefit the patient (e.g use of emollients and topical steroids), but many patients have complex disease and can present with more than one condition so careful assessment and individualised management is essential. Understanding of when to refer onwards to a vulval specialist service is important to optimize clinical outcomes. Clinical outcomes to consider for all patients with vulval skin disease should include 1) A reduction in symptoms (eg less itch, fewer flare-ups), 2) An improvement in function (eg sexual function, mobility), 3) Increased confidence in self-management (eg management of flare-ups and self-examination)

Erosive lichen planus affecting the vulva: defining the disease, developing outcome measures and designing a randomised controlled trial

Erosive lichen planus affecting the vulvovaginal region (ELPV) is a rare chronic inflammatory condition causing painful raw areas that can lead to scarring, at the vaginal entrance. Symptoms considerably impact upon daily function and quality of life. There is risk of cancerous change in affected skin of 1-3%. A Cochrane Systematic Review, published in 2012, found no randomised controlled trials (RCT) on which to base treatment for ELPV. Retrospective case series suggest that super-potent topical corticosteroids are frequently used as first-line therapy, although one third of patients fail to respond adequately and require escalation of therapy. There is clinical uncertainty regarding which second-line therapies should be used. The following steps were taken to inform the design of an RCT to determine optimal second-line therapy for EVLP resistant to topical steroids: • A multi-centre retrospective review and audit of case notes to assess current clinical management in the UK. • A qualitative investigation with UK clinicians to establish their views and principles of management of ELPV. • An international multi-disciplinary electronic-delphi consensus exercise to agree a set of diagnostic criteria for ELPV. • A systematic review to assess existing outcome measure tools that have been used in randomised controlled trials of vulval skin disorders. • Assessment of patients views through a survey of a national patient group and subsequent focus groups with patients. The resulting multi-centre, four-armed, open-label, pragmatic randomised controlled trial will compare hydroxychloroquine, methotrexate and mycophenolate mofetil against a standard care group of clobetasol propionate 0.05% plus a short course of oral prednisolone. This will be the first RCT to test systemic agents for patients with ELPV and will add to the existing evidence base. The methodologies employed to develop the RCT protocol, and the trial design itself, may act as a template for clinical research into the therapeutic management of other rare inflammatory conditions

Erosive lichen planus affecting the vulva: defining the disease, developing outcome measures and designing a randomised controlled trial

Erosive lichen planus affecting the vulvovaginal region (ELPV) is a rare chronic inflammatory condition causing painful raw areas that can lead to scarring, at the vaginal entrance. Symptoms considerably impact upon daily function and quality of life. There is risk of cancerous change in affected skin of 1-3%. A Cochrane Systematic Review, published in 2012, found no randomised controlled trials (RCT) on which to base treatment for ELPV. Retrospective case series suggest that super-potent topical corticosteroids are frequently used as first-line therapy, although one third of patients fail to respond adequately and require escalation of therapy. There is clinical uncertainty regarding which second-line therapies should be used. The following steps were taken to inform the design of an RCT to determine optimal second-line therapy for EVLP resistant to topical steroids: • A multi-centre retrospective review and audit of case notes to assess current clinical management in the UK. • A qualitative investigation with UK clinicians to establish their views and principles of management of ELPV. • An international multi-disciplinary electronic-delphi consensus exercise to agree a set of diagnostic criteria for ELPV. • A systematic review to assess existing outcome measure tools that have been used in randomised controlled trials of vulval skin disorders. • Assessment of patients views through a survey of a national patient group and subsequent focus groups with patients. The resulting multi-centre, four-armed, open-label, pragmatic randomised controlled trial will compare hydroxychloroquine, methotrexate and mycophenolate mofetil against a standard care group of clobetasol propionate 0.05% plus a short course of oral prednisolone. This will be the first RCT to test systemic agents for patients with ELPV and will add to the existing evidence base. The methodologies employed to develop the RCT protocol, and the trial design itself, may act as a template for clinical research into the therapeutic management of other rare inflammatory conditions

Prospectus, September 22, 1982

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Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

Abstract Background Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. Methods We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. Results The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. Conclusion The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.http://deepblue.lib.umich.edu/bitstream/2027.42/78272/1/1748-5908-4-50.xmlhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/2/1748-5908-4-50-S1.PDFhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/3/1748-5908-4-50-S3.PDFhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/4/1748-5908-4-50-S4.PDFhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/5/1748-5908-4-50.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/78272/6/1748-5908-4-50-S2.PDFPeer Reviewe