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

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 13/11/01. The contractual start date was in January 2014. The draft report began editorial review in October 2014 and was accepted for publication in April 2015. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

none

Copyright statement

© Queen’s Printer and Controller of HMSO 2015. This work was produced by Pickett et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Description of the underlying health problem

Chronic inflammatory skin diseases are commonly encountered conditions in dermatology. They include commonly reported conditions, such as eczema, psoriasis and acne, which are associated with skin inflammation. This inflammation can range in severity from mild to severe and, in some patients, can have associated health complications. The focus of this report is on chronic inflammatory skin diseases that have lasted for at least 12 weeks and may have caused significant tissue destruction and, potentially, impacted the individual significantly. Our initial scoping of this project identified a number of conditions that come under the term chronic inflammatory skin diseases; however, only the most commonly studied in educational intervention studies are discussed in the background of this report.

Epidemiology

Scholfied and colleagues1 undertook a health-care needs assessment in 2009 and reported that 55% of the overall population in the UK have had some form of skin disease, and that in previous studies 23–33% of people have had a skin problem that could benefit from medical care (i.e. a moderate or severe condition). This section presents a brief overview of the incidence and prevalence across the different inflammatory skin conditions discussed above.

Impact of the diseases

People with inflammatory skin conditions can experience symptoms including itching (and sometimes pain), dry skin and changes in skin appearance, to varying degrees of severity and bodily involvement. 5,7,29 The symptoms can be distressing for patients and their carers31,32 and, in some cases, can lead to functional impairments, particularly when conditions affect the face, genitalia, hands and feet. 7 In adults, reduced levels of employment and income have been noted in psoriasis7 and more severe acne vulgaris. 9 Patients can feel stigmatised by their condition owing to visible skin symptoms and changes in appearance,31,33,34 which may contribute to distress35 and impact on their social interactions,33,34,36 normal activities (e.g. going to a public swimming pool or to the hairdressers) and relationships with people, including sexual relationships. 34 Sleep quality can also be affected owing to itching and scratching which can be particularly intense at night, and the sleep of carers can also be disrupted through dealing with symptoms at night. 31

Chronic inflammatory skin conditions are associated with high levels of psychological comorbidities, including depression and anxiety,31,35,37–39 and reduced health-related quality of life (HRQoL),9,33,39,40 which does not always correlate with disease severity. 41–43 Psychological difficulties and stress, along with symptoms (such as itching), undergoing treatment and concerns about appearance may negatively impact patients’ HRQoL. 33,39,40 Self-managing a long-term skin condition, with a relapsing and remitting course, is demanding for patients and their carers, and patients may feel that they lack control owing to the unpredictability of the disease on a weekly, or even daily, basis. 31 Poor psychological health can lead to a vicious cycle in patients where symptoms can be exacerbated by stress44 and reduced HRQoL may lead to less adherence to treatment regimens, reducing the effectiveness of treatment and resulting in greater use of health-care resources. 45

HRQoL is a commonly used outcome measure in health care to evaluate the impact of disease on patients’ lives. It is defined as a person’s subjective experience and perception of the impact that their health status has on their physical, psychological and social functioning. 46,47 HRQoL instruments measure various dimensions of these three domains, including physical symptoms, social activity, mental health, ability to carry out normal activities, life satisfaction and perceived health status,34,46,48 although the specific dimensions measured vary according to the instrument used. 48 HRQoL is a distinct concept from psychological distress (e.g. depression or anxiety), although, as described above, experiencing psychological distress is associated with poorer HRQoL in chronic inflammatory skin conditions.

Measurement of disease

A wide range of validated instruments are used to measure HRQoL and disease severity in patients with chronic inflammatory skin diseases. The Dermatology Life Quality Index (DLQI) is one of the most frequently used instruments in studies in dermatology. It has been used extensively in studies of over 40 different skin conditions, although the most common conditions it has been used for are psoriasis, atopic eczema and acne. 49 Other common measures include the Infants’ Dermatitis Quality of Life Index (IDQoL), which is aimed at children aged 0–4 years old,50 the Children’s Dermatology Life Quality Index (CDLQI), which is aimed at children aged 4–16 years, the Quality of life in Primary Caregivers of children with Atopic Dermatitis (QPCAD), and the World Health Organization Quality of Life-26 items (WHOQOL-26). These instruments cover a range of dimensions of HRQoL, including the severity of the condition, quality of sleep, coping, adherence with treatment, satisfaction and the impacts on family members, partners or carers. Some of the instruments that have been developed specifically for use in children (such as CDLQI and Quality of Life in Children Aged 14–16 Years) use proxy judgements made by someone else, such as a parent or carer.

Some of the common measures of disease severity include the Psoriasis Area Severity Index (PASI), the Self-Administered Psoriasis Area Severity Index (SAPASI), the Patient-Oriented Eczema Measure (POEM), the SCORing Atopic Dermatitis (SCORAD) and the Psoriasis Disability Index (PDI).

Appendix 1 gives an overview of some of these common instruments, including definitions of clinically meaningful changes where this is known (that is, the degree of change that is considered to be of benefit to the patient and their disease management, regardless of whether the change is statistically significant46).

Impact on the NHS

The need to improve patients’ HRQoL and for clinicians to take a holistic approach to managing patients’ skin conditions has been advocated in the research literature34 and clinical guidelines. 5,7 This might benefit both patients and the NHS through reduced use of health-care resources. It was estimated (using 2005/6 data) that 2.23% of the total NHS expenditure (£140M) was spent on diseases of the skin and subcutaneous diseases. 1 This included prescribing costs, outpatient and inpatient costs, but not primary care consultations, which could add another £395M. 1 In a national statistical report published by the Health and Social Care Information Centre51 on prescriptions dispensed in the community in England from 2003–13, the costs of emollient prescriptions in the year 2013 were estimated at £105,000, although these were prescribed for a range of conditions and not just for inflammatory skin diseases.

A UK-based study1 estimated the direct costs of skin diseases to the individual and to the NHS. It reported a year-on-year increase in over-the-counter (OTC) sales of the skin disease treatments in the UK from 2001 to 2007. The OTC sales for such conditions were £413.9M in 2007; this was 18% of the total OTC sales. Of the total prescribing budget, 2.85% (£237.7M) was for prescribing costs for skin disease in England in 2007. The study reported an estimated cost of about £395M per year, or 4.4% of the General Medical Services budget for GP consultations in England and Wales. In the year 2005/6, the overall direct costs (including medical care and products) of providing care for people with skin diseases was reported as about £1819M in England and Wales. It was observed that the direct cost of skin disease to the NHS was relatively low despite the conditions being very common. 1

Current service provision

A brief overview of the management of different chronic inflammatory skin diseases with relevance to the UK is discussed in the context of the relevant national guidelines as outlined below, including the role of education in the treatment of these conditions. Educational interventions are typically defined as providing patients with information about, and training in, skills for managing their condition. 52 In its simplest sense, education can be thought of as the provision of information that is intended to influence a specified outcome. In general, educational interventions involve encounters between teachers and learners for one or more of the following purposes: to raise awareness, to enhance or improve knowledge, or to change behaviour. 53

Description of the technology under assessment

As stated, educational interventions are typically defined as providing patients with information about and training in skills for managing their condition (see Current service provision). 52 People with chronic skin conditions and their carers have several educational needs. These include an understanding of the condition (typically chronic and relapsing, with no cure at present, but in general manageable), an opportunity to try treatments to find those that suit them best, reassurance that many treatments are generally safe and effective, guidance on how best to apply topical treatments, and motivation to continue treatment when the disease is in remission. 59 Educational interventions have traditionally been based on what health-care experts believed patients need to know about their conditions rather than patients’ expressed needs. 60,61 Recently, however, there has been a movement in medicine towards greater patient involvement in treatment and patient-centred care. 62 A more patient-empowering subset of educational interventions are self-management educational interventions, which focus on enabling patients to develop problem-solving skills and teach patients actions that they can take to resolve issues (including emotional and psychosocial issues) relating to their condition when they arise. 52 Self-management educational interventions will often involve the creation of patient action plans52 and represent a collaborative approach between HCPs and patients. 60 Patient activation is also an important part of promoting self-management in chronic diseases. 63 Patient activation is defined as the extent to which patients believe and have confidence that they can play an active part in managing their health and the extent to which they carry out and maintain activities which can positively impact their condition and health more broadly. Patient activation is associated with better QoL in patients in general64 and potentially could be improved through patient education.

Educational interventions may be delivered in a variety of ways, may include a number of inter-related elements that either singly or together may bring about change in an outcome and some tailoring to individual patient or carers’ needs, and therefore could be considered ‘complex interventions’. 65 Medical Research Council (MRC) guidance on the development and evaluation of complex interventions emphasises the importance of early groundwork in developing an intervention. 65 This should include specification of a clear theoretical basis for the intervention that outlines its rationale and how it might bring about change in the outcomes of interest, drawing on available evidence and theoretical models. This is because theory-based interventions tend to be more effective than those that are not theory-based. The MRC guidance additionally recommends carrying out research, such as qualitative work, with potential users, deliverers or creators of the intervention to supplement existing theory and evidence, if needed, to further inform intervention development. The guidance also recommends that systematic reviews of current evidence for the effectiveness of the intervention and pilot studies (e.g. to evaluate feasibility) are carried out.

As another consideration in intervention development and delivery, it is also recommended in the wider literature that educational interventions in dermatology should be sensitive to and take account of patients’ social and cultural backgrounds, including their education level, literacy and preferred language, and their favoured learning methods. 66,67 Some degree of tailoring of the intervention to individual needs might also be beneficial, as it has been found in health care generally that tailored interventions result in better outcomes than more generic ones. 68 Consideration might also be given to the characteristics of the intervention deliverer, because it has been suggested that interventions delivered by people who have similar characteristics to the intervention participants (such as similar social and ethnic backgrounds) might be more effective than those delivered by people who differ to the participants. 70 Ideally, evaluations of complex interventions should include process evaluations to gain insight into contextual factors during intervention delivery that may impact its effectiveness. 65

Research studies have investigated a wide variety of approaches for educating patients with chronic inflammatory skin diseases – mostly those with eczema and psoriasis, and, in some cases, their carers or families also. 2,36,55,70 The existing evidence for educational interventions in general shows variability in whether these interventions are effective in improving HRQoL, but some studies have shown positive effects. 55,60,71 A systematic review of educational interventions for children with eczema and their parents suggests that programmes for parents that are delivered by either a nurse or a multidisciplinary team may lead to improvements in infant and child HRQoL and disease severity. 71 However, there is currently little understanding overall about which elements of educational interventions make them effective in improving HRQoL and other outcomes. 60,61

Our project Advisory Group of patients, HCPs and researchers indicated that educational interventions are generally not widely used in UK clinical practice to supplement medical treatment for patients with chronic inflammatory skin conditions. The Group suggested that education in primary care is especially limited and will generally involve verbal instructions on medication use, provision of information leaflets and sign-posting to other information sources. The Group stated that educational interventions are more commonplace in secondary care and are often nurse-led and more likely to be planned and structured. These tend to involve information giving and advice, combined with paper- or web-based information. The Group stated that, overall, educational interventions are not sufficiently individualised and the creation of action plans is rare.

As part of educational interventions, patients with chronic inflammatory skin conditions are often provided with information about their condition and the use of treatments. However, it has been suggested that the impact of standard education in dermatology on HRQoL could be enhanced by the additional inclusion of elements that address issues related to HRQoL. This review focuses on these additional elements as per the commissioning brief. Our Advisory Group was aware of only two UK educational programmes that specifically aim to improve HRQoL. One is The Eczema Education Programme,72 which is a nurse-led programme delivered in the community and a specialised centre, which aims to improve parents’ and carers’ management of their child’s eczema and parents’ QoL. Elements covered in the programme include: understanding the disease, trigger factors and treatment; enhancing parental confidence in using treatments; action planning; and practical strategies for reducing itching and sleep problems. A before- and after- study evaluation of the programme73 found improvements in infant, child and parental HRQoL, indicating that this may be a potentially successful approach. The other programme is an online intervention delivered through the Supporting Parents and Carers of Children with Eczema (SPaCE) website for carers of children with eczema. 74

As with educational interventions in general, it is currently unclear which specific elements of these interventions may enhance HRQoL or what factors should be targeted to lead to improvements in HRQoL. Where complex educational interventions for chronic skin diseases involve multiple interacting components it may not be possible to identify which intervention components are responsible for observed effects on outcomes. 75,76 However, taxonomies of intervention techniques may be used, if appropriate, to map which intervention components may be related to improved outcomes. 69,77 In line with the MRC complex interventions guidance,65 authors of some studies evaluating educational interventions for childhood eczema aimed at improving HRQoL have provided information on the underlying theory of change. These studies have hypothesised that educational interventions may improve HRQoL through enhancing the ability to manage the disease,72,74,78 increasing self-efficacy72,78 (that is, patients’ or carers’ confidence in their ability to successfully manage the condition79), promoting positive outcome beliefs and behavioural capability78 and through the use of a number of other behaviour-change techniques. 74 As far as the authors of this review are aware, however, a clear theoretical basis for such interventions, including potential underlying mechanisms of change, has not been adequately outlined in the literature.

Based on opinion from our Advisory Group, addressing the following factors may differentiate educational interventions aimed at improving HRQoL from general educational interventions: unpredictability of the disease, interaction of multiple factors, impact of everyday life (e.g. family, tiredness and personal and work life) on the condition, mental well-being, negative thinking, coping skills (e.g. to cope with the disease or for managing psychological distress), problem-solving and action planning, and management of medication side effects. Additionally, the Group suggested that it may also be important to cover issues relating to parental guilt associated with passing on a genetic disease, and parents’ or carers’ empathy and appreciation of the impact of the disease. The Group also stated that educational interventions that improve condition management may also result in improvements in HRQoL and emphasised the potential importance of theory-based interventions in enhancing the effects of an intervention on this (e.g. through the incorporation of elements hypothesised to improve self-efficacy from social cognitive theory80). The literature shows that experiencing psychological difficulties, such as depression, is associated with poor HRQoL in chronic inflammatory skin diseases, among other factors,33,39,40 and patients experiencing a high psychosocial burden from their disease have been identified as a (psoriasis) subgroup requiring additional support. 81 Based on a model of delivery of psychosocial interventions for skin conditions generally,82 recommended nurse-delivered interventions for patients experiencing mild to moderate psychosocial distress include training in relaxation techniques, scratching habit reversal, problem solving and ways of camouflaging skin. It may be reasonable to assume that if these aspects are part of educational interventions, they may also help enhance HRQoL.

In light of limited existing evidence, there is uncertainty about best practice methods for educational interventions. Therefore, systematic reviews of clinical effectiveness as well as cost-effectiveness of educational interventions aimed at improving QoL in people with chronic inflammatory skin diseases are required.

Overall aims and objectives of assessment

The aim of this health technology assessment is to undertake systematic reviews of the clinical effectiveness and cost-effectiveness of educational interventions for people with chronic inflammatory skin diseases.

The main objectives are:

1. to conduct systematic reviews of the clinical effectiveness and cost-effectiveness of educational interventions for improving HRQoL in patients with chronic inflammatory skin diseases

2. if data permit, to adapt an existing economic model or construct a de novo model from the perspective of the UK NHS to estimate the cost-effectiveness of educational programmes for chronic inflammatory skin diseases

3. to identify deficiencies in current knowledge and to generate recommendations for future research.

Identification of studies

A comprehensive search strategy was developed, tested and refined by an experienced information specialist. Separate searches were conducted to identify studies of clinical effectiveness and cost-effectiveness. Sources of information and search terms are provided in Appendix 2. The most recent searches were undertaken in July 2014.

Literature was sourced from 12 electronic databases, the bibliographies of included articles and relevant systematic reviews, and our expert Advisory Group were contacted to identify any additional studies. All databases were searched from inception and limited to the English language. The following electronic databases were searched:

• The Cochrane Library, including the Cochrane Database of Systematic Reviews (CDSR), the Cochrane Central Register of Controlled Trials, Centre for Reviews and Dissemination (University of York) Database of Abstracts of Reviews of Effectiveness (DARE), the NHS Economic Evaluation Database (NHS EED) and the Health Technology Assessment (HTA) database

• MEDLINE (Ovid)

• EMBASE (Ovid)

• MEDLINE In-Process & Other Non-Indexed Citations (Ovid)

• Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus with full text (EBSCOhost)

• PsycINFO

• Web of Science: Science Citation Index Expanded (SCIE) and Conference Proceedings Citation Index – Science (CPCI) (ISI Web of Knowledge)

• Global Resource for Eczema Trials (GREAT) database (University of Nottingham).

A comprehensive database of relevant published and unpublished articles was constructed using Reference Manager (Thomson ReseachSoft, San Francisco, CA, USA) software. Research-in-progress databases were searched for any ongoing studies of relevance.

Searches for ongoing studies were undertaken in the following databases: UK Clinical Research Network (UKCRN), controlled-trials.com, clinicaltrials.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), Centre for Evidenced Based Dermatology (University of Nottingham), UK Clinical Trials Gateway (UKCTG).

Inclusion and exclusion criteria

Studies were eligible for inclusion in the systematic reviews if they met the criteria outline below.

Study selection and data extraction strategy

Studies were selected for inclusion in the systematic review of clinical effectiveness through a two-stage process using the predefined and explicit criteria specified above. Titles and abstracts from the literature search results were independently screened by two reviewers to identify all citations that possibly met the inclusion criteria. Full papers of relevant studies were retrieved and assessed by one reviewer and checked by a second reviewer using a standardised eligibility form. As far as possible, full papers or abstracts describing the same study were linked together, with the article reporting key outcomes designated as the primary publication. Any disagreements between reviewers were resolved by consensus or if necessary by arbitration by a third reviewer.

Titles and abstracts identified by the search strategy for the systematic review of cost-effectiveness were assessed for potential eligibility by two reviewers using the predetermined inclusion criteria. Full papers were formally assessed for inclusion by one reviewer with respect to their potential relevance to the research question and this was checked by another reviewer. Any disagreements between reviewers were resolved by consensus or if necessary by discussion with a third reviewer.

Data were extracted by one reviewer using a standard data extraction form and checked by a second reviewer. At each stage, any disagreements between reviewers were resolved by consensus or, if necessary, by arbitration by a third reviewer.

In the systematic review of clinical effectiveness, for each study, results for outcomes measured at the immediate end of the intervention and the longest follow-up time point (where this differed) were extracted and presented. That is, results for any intermediary time points were not extracted. During data extraction, a modified version of Schulz and colleagues’69 intervention taxonomy was used to structure how and which information was extracted about the educational interventions in the included studies. The taxonomy characterises the different elements of interventions. Based on this, the following intervention components were extracted for each study: where it was delivered; whether it was a form of self-help; whether it was individual- or group-based; mode; materials used; provider; duration and intensity; scripting (use of a protocol guiding interaction between the interventionist and participants); sensitivity to participant characteristics; interventionist characteristics and training; content and topics (including educational strategies used); tailoring; and theoretical basis. Reviewers additionally extracted the following: intervention overview and aims; stated target group; ongoing support provided; and whether individuals’ preferred learning styles were taken into account.

Critical appraisal strategy

The methodological quality and the quality of reporting of the included clinical effectiveness studies were assessed using risk of bias criteria based on those recommended by Cochrane83 (see Appendix 3). Quality criteria were applied by one reviewer and checked by a second reviewer, with any differences in opinion resolved by consensus or by arbitration by a third reviewer.

Quality assessment for the systematic review of cost-effectiveness was based on a checklist for economic evaluation publications. 84

Method of data synthesis

Studies of clinical effectiveness and cost-effectiveness were synthesised through a narrative review with tabulation of results of included studies. In the systematic review of clinical effectiveness, studies were grouped according to the condition being considered and the general age group of the participants.

It was not considered appropriate to combine the studies in a meta-analysis owing to the heterogeneity between studies in patient characteristics (ages, conditions, duration of disease, severity of disease), the interventions and the comparators.

Advisory group

The Advisory Group informed the protocol and provided comments on the near complete draft report. In addition, members of the Advisory Group provided responses to specific questions around the current use of educational interventions for chronic inflammatory skin disease, which informed the background section of the report.

Quantity and quality of research available

Figure 1 shows the flow of studies through the review. Eight studies74,76,85–90 met the inclusion criteria. Of these, seven were RCTs74,76,85–89 and one was a controlled clinical trial (CCT). 90 The CCT90 evaluated an educational intervention for psoriasis. In line with our review protocol, which pre-specified that CCTs would only be included if no RCT evidence existed for a particular condition, the CCT is not discussed further because RCT evidence was available for psoriasis.

FIGURE 1.

Flow chart for the identification of studies in the review of clinical effectiveness. CCT, controlled clinical trial.

Searches identified 2628 records, of which 2565 were excluded at title and abstract screening. At the full-text screening stage of the review, 63 references were reviewed and 55 were excluded. The main reasons for exclusion were that studies did not measure HRQoL using a validated measure (n = 28) or that the intervention was not an educational intervention that aimed to, or could, improve HRQoL, and/or the effect of the educational component of the intervention on outcomes could not be isolated from the effect of other non-educational components of the intervention (n = 14) (see Appendix 5 for a full list of reasons for specific exclusions). Three studies, reported in four publications,78,91–93 were excluded for not reporting results in sufficient detail to be informative in the review. Of these, one reported in Staab and colleagues93 and Wenninger and colleagues78 was a RCT examining a theory-based programme called the ‘Berlin education programme’ for parents of children with atopic dermatitis, aimed at improving HRQoL and the disease course, which covered medical, nutritional and psychological issues. The authors reported limited numerical data in the results. For example, data were reported for only one of the five dimensions of a disease-specific HRQoL measure. The other two excluded studies were Jaspers and colleagues91 and Lora and colleagues,92 which were RCTs of a combined psychoeducational and dermatological treatment programme delivered by a multidisciplinary team for young adults with atopic dermatitis and a psychoeducation programme for patients with psoriasis, respectively. Jasper and colleagues91 provided numerical results for only one domain of the Short Form questionnaire-36 items (SF-36) (HRQoL measure) at 10 weeks post intervention and narratively reported changes for other domains at 10, 20 and 40 weeks post intervention as non-significant. Lora and colleagues92 presented no results for the HRQoL measure they used. Such exclusions as a result of poor quality reporting are important to note, because these studies otherwise met the review inclusion criteria and formed around one-third of the relevant evidence-base – this issue is considered further below (see Discussion).

Characteristics of the included trials

Table 2 provides an overview of the characteristics of the seven included RCTs. Detailed information about the educational intervention(s) evaluated in each RCT is provided in Table 3, with full details also provided in Appendix 6. The full data extraction forms are shown in Appendix 4. Two RCTs, by Balato and colleagues85 and Ersser and colleagues,86 assessed the effects of daily text message education over 12 weeks and a one-off nurse-delivered educational session for adults with psoriasis; one RCT by Matsuoka and colleagues88 focused on instructions in make-up use and skin care from a dermatologist to adult women with acne; and two RCTS, by Staab and colleagues87 and Santer and colleagues,74 focused on children (and adolescents in one trial87) with atopic dermatitis and their parents or carers, evaluating a 6-week educational programme delivered by a multidisciplinary team and an educational website (the ‘SPaCE website’), respectively. The educational interventions in the remaining two RCTs, by van Os-Medendorp and colleagues89 and Bostoen and colleagues,76 were delivered to people with a mixture of skin conditions. van Os-Medendorp and colleagues89 included people with chronic pruritic skin diseases (including eczema, atopic dermatitis, pruritus, prurigo, psoriasis and chronic urticaria) and evaluated a ‘Coping with itch’ programme, and Bostoen and colleagues76 included people with either psoriasis or atopic dermatitis in an evaluation of a 3-month programme delivered by a multidisciplinary team.

Five of the included RCTs74,76,86,88,89 compared educational programmes with standard care for the skin condition. Balato and colleagues85 and Staab and colleagues87 compared the text message education and 3-month educational programme with a ‘control intervention’ and a ‘no education control’, respectively, but did not provide details about what, if any, treatment was given to the control conditions. In six RCTs74,76,85,86,88,89 the educational interventions were delivered as an adjunct to standard medical care, and it was unclear if it was an adjunct in the remaining trial evaluating the 6-week programme including children with atopic dermatitis and their carers. 82 Only one RCT74 compared two different approaches to the education delivery, in addition to comparing each educational approach with standard care. This trial compared education delivered through the SPaCE website only with education delivered through the same website, but with additional support through a one-off appointment with a HCP who promoted engagement with the website and supported participants in completing some of the modules.

Only two UK studies were identified. 74,86 One examined the effects of a one-off educational session for patients with psoriasis in primary care86 and the other was also set in primary care, but provided education mainly through the SPaCE website. 74 The other RCTs were conducted in a range of countries and settings, including secondary care in the Netherlands89 and Japan88 and home-based education in Italy. 85 In the remaining RCT,76 conducted in Belgium, the setting was unclear. The generalisability of these studies to the UK setting is, therefore, unclear.

No studies of any other chronic inflammatory skin diseases were identified in our searches.

All tables are ordered by condition and then by patient age group within condition.

The largest RCT was of 992 children and adolescents with atopic dermatitis and their parents. 87 One other RCT of mixed skin conditions had a sample size of 120 participants89 and another of children with eczema and their parents or carers had a sample size of 149. 74 Sample sizes in the four remaining trials,76,85,86,88 including all the RCTs of patients with psoriasis, ranged from 40 to 64 participants. One study measured outcomes at the end of the intervention only,85 with the other six74,76,86–89 employing various lengths of post-intervention follow-up, ranging from 4 weeks88 to 12 months. 87 Three studies76,87,89 had a follow-up of a reasonable duration to capture the clinical effects of the intervention (≥ 3 months post intervention; which the review Advisory Group suggested would be the minimum follow-up time necessary in studies to measure the effect and durability of patient benefits from an intervention).

Aims, content and structure of the educational interventions in the included trials

During data extraction, a modified version of a taxonomy of elements of interventions developed by Schulz and colleagues69 was used to structure how information about the interventions in each trial was recorded (see Methods for more information about this). Following this principle, an overview is provided here of the educational interventions in each trial, with summary details shown in Table 3. More detailed information about the interventions, covering all elements extracted, can be found in Appendix 6.

The aims, content and structure of the educational interventions were heterogeneous across the seven included RCTs. Only one of the included studies,74 of the SPaCE website intervention, explicitly reported that the aim of the intervention was to improve HRQoL (although another, by Staab and colleagues,87 was in part based on the ‘Berlin education programme’ reported in the excluded Staab and colleagues93 and Wenninger and colleagues78 publications, and these linked publications state that the aim of the intervention was to improve HRQoL; see Table 3 for more details). The other studies were included in the review because it was inferred from the content that the intervention could improve HRQoL (e.g. it included aspects that targeted compliance or patients’ ability to cope with the negative effects of their disease).

Three of the studies reported that the educational interventions were theory-based. The one-off educational session for patients with psoriasis in Ersser and colleagues86 and the 6-week programme for atopic dermatitis in Staab and colleagues87 were based on social cognitive theory. The SPaCE website intervention in the trial by Sanler and colleagues74 incorporated 20 of the 26 behaviour-change techniques listed in Abraham and Michie’s77 taxonomy of behaviour-change techniques. The design of the intervention in Ersser and colleagues86 was additionally informed by findings of previous qualitative research on the self-management needs of individuals with psoriasis. Similarly, the design and content of the SPaCE website in Santer and colleagues74 was based on qualitative interviews and input from a patient support group, as well as evidence-based patient information leaflets, ‘think-aloud’ interviews with users of a draft version of the website and feedback from other parents and HCPs.

The educational content and strategies used in the interventions varied across the studies. All the trials except one86 reported that participants were provided with information about the skin disease, its treatment, skin care, or the causes, consequences and treatment of itch. The interventions also commonly included education about stress-reducing or relaxation techniques (reported in five RCTs74,76,86,87,89) and living a healthy lifestyle and/or nutritional issues (reported in five RCTs74,76,85,87,89). Other psychosocial aspects included education on coping with the disease and managing itching, scratching and sleep,74,87,89 managing the psychosocial consequences of the disease,85 and provision of information about patient support groups. 89 The SPaCE website for carers of children aged 5 years or younger with eczema also contained information about how to involve their child in their treatment and guidance for carers on how to manage a consultation with their GP. 74 The intervention in the trial by Matsuoka and colleagues,88 in which patients with acne were provided with instructions on skin care and make-up use, could be considered to help patients manage appearance concerns and the feelings of stigma associated with their condition. As well as information provision, the reported education strategies used included encouraging participants to share experiences,87 discussion of difficulties in transferring newly learnt skills into their everyday lives,87 individual action planning or creation of (self-)management plans,74,86,87,89 feedback sessions,76 a 2-week challenge involving short message service (SMS) text alerts for setting goals, monitoring and rehearsing behaviours,74 and cognitive behavioural therapy, including habit reversal to reduce scratching. 89 Where reported, the duration and intensity of the educational interventions ranged from two 20-minute compulsory online modules (plus optional additional modules)74 to a 3-month programme consisting of two 3-hour sessions a week. 76

In all the RCTs except one,85 educational interventions were delivered at least in part through face-to-face sessions, and in three trials it was also delivered in groups. Group sizes across and within the studies ranged from 5 to 23 participants. 76,86,87 In the RCT by Santer and colleagues,74 the intervention was mainly delivered online (via the SPaCE website), but one group also received additional support from a HCP in a face-to-face appointment. Participants could also opt to take part in a 2-week challenge, which involved receiving behavioural prompts by text message. It is unclear if the instructions in skin care and using make-up were provided to patients individually or as part of groups in the RCT by Matsuoka and colleagues. 88 In one trial85 education was provided to individuals solely by daily text messages, over a period of 12 weeks. The educational interventions were delivered by a multidisciplinary team in two RCTs,76,87 a nurse in another two RCTs86,89 and a dermatologist in one RCT. 88 In the Santer and colleagues RCT,74 the SPaCE website, which had been developed by medical experts and informed by patient support groups, was the main delivery mechanism. The HCPs who provided support to one group varied across the general practices taking part and were the practice nurse in 11 practices, a health-care assistant in one practice and a GP in one practice. Only one of the HCPs was dermatology trained. In the remaining RCT, of text message education,88 it was unclear who provided the intervention. Three trials74,86,87 reported information about the interventionist characteristics, with all stating that the interventionists received training prior to delivering the programmes (although this was minimal in Santer and colleagues74 and consisted of 1 hour for the HCP to familiarise themselves with the SPaCE website). None of the RCTs provided information about whether the people delivering the educational interventions had similar characteristics to the patients taking part, such as similar social and ethnic backgrounds.

Ersser and colleagues,86 Bostoen and colleagues76 and Staab and colleagues87 reported that the interventionist was required to follow a protocol, syllabus or content manual, respectively, to standardise delivery. Delivery of the text message85 and website education74 was also standardised (but with some optional as well as compulsory modules on the website). In Ersser and colleagues,86 there was flexibility for the intervention to be tailored to participants’ needs. Another two RCTs74,89 also reported that, to some extent, the educational interventions were tailored to patients’ individual needs. The interventions in two trials85,87 were sensitive to participants’ characteristics to some extent, by providing parent and child education according to age group87 and ensuring that text messages were written in simple language. 85 None of the interventions took into account individuals’ preferred learning styles.

Outcomes assessed in the included trials

As per our inclusion criteria, all seven RCTs measured HRQoL using one or more validated measures. All seven trials also measured disease severity as an outcome. Other measured outcomes were: depression, stress, lifestyle (measured by a set of unvalidated questions in one trial76), health resource use, medication and ointment use, cost-effectiveness, itching behaviour, itch-related coping, skin-related psychosocial morbidity, general psychosocial morbidity, patient–physician relationship, attitudes and perceptions of ability to manage the condition, and treatment adherence. Only one trial88 measured adverse events. In line with our protocol, patient-reported outcome measures were extracted and included in the review only if assessed by validated tools. HRQoL was a primary outcome in four of the trials76,86,87,89 and a secondary outcome in one trial. 74 The remaining two trials85,88 did not specify if outcomes were primary or secondary. Three RCTs74,85,86 included process measures that could be regarded as ‘process evaluations’ (e.g. assessing patients’ perceptions of the usefulness of the intervention).

Four of the included trials76,85,86,88 measured HRQoL using the DLQI, which is a dermatology-specific, self-report measure. 95 van Os-Medendorp and colleagues89 measured HRQoL using the QoL subscale of the Adjustment to Chronic Skin Diseases Questionnaire (ACS), which measures skin-related psychosocial morbidity. Staab and colleagues87 measured parents’ HRQoL using the German questionnaire ‘Quality of life in parents of children with atopic dermatitis’. Santer and colleagues74 measured the impact of the website for carers on each family’s QoL using the Dermatitis Family Impact (DFI) questionnaire and also measured the impact on the carers’ children’s HRQoL using the IDQoL (for children aged ≤ 4 years) and the CDLQI (for children aged ≥ 5 years). Other HRQoL measures used in the RCTs were: Skindex-29,76 PDI,76 Quality of Life Index for Atopic Dermatitis (QoLIAD)76 and WHOQOL-26. 88 For more information about the most commonly used measures and how they are interpreted, please see Appendix 1.

Disease severity was assessed using a range of measures, including the PASI (used in all three trials that included patients with psoriasis76,85,86), the SCORAD (used in two studies including patients with atopic dermatitis76,87) and the POEM (used in a study of children with eczema and their carers74). Other measures used were the Plewig and Kligman’s grade measure of acne severity88 and a patient-reported measure of the frequency and intensity of itching. 89 For more information about the most commonly used measures and how they are interpreted, see Appendix 1.

Participants’ baseline characteristics

Table 4 shows the baseline characteristics of the participants randomised in each of the trials. Generally, across the trials, 50% or more of the participants in each study arm were women. The RCT by Matsuoka and colleagues,88 which evaluated skin care and make-up instructions for patients with acne, focused exclusively on women. Most carers of children randomised in the trial by Santer and colleagues74 were women. The overall mean age of participants in the studies of adult patients ranged from 3885 to 59 years,86 except in the trial by Matsuoka and colleagues88 where the mean age of the women was 24 years and 25 years in each arm. In the trial of children and adolescents with atopic dermatitis,87 the baseline mean ages were around 2 years in the 3 months to 7 years age group, 10 years in the 8–12 years age group and 15 years in the 13–18 years age group. In Santer and colleagues,74 the majority of carers were aged between 26 and 40 years and the ages of the children were between 0 to 5 years, as per the study inclusion criteria. None of the trials reported the participants’ ethnicity. Across the four trials reporting participants’ socioeconomic characteristics,74,76,85,89 there was a mixture of levels of education and employment status, see Table 4.

Five trials reported the length of time participants had had their skin condition. 76,85,86,88,89 In four trials, the disease duration ranged from a mean of around 11 to 24 years. 76,85,86,89 Patients with acne in the trial by Matsuoka and colleagues88 had been diagnosed with their condition for a slightly shorter duration (for a mean of 7 years and 4 years in each study arm). Only two studies reported participants’ comorbidities, and these included hypertension, dyslipidaemia, type 2 diabetes and unspecified ‘complications’. 85,88 Where measured with the same tool, baseline disease severity was similar across trials of the same condition. An exception was that participants in the trial by Ersser and colleagues86 had milder psoriasis than the participants in the two other psoriasis trials (this may be because the participants in Ersser and colleagues were recruited from primary care). 76,85

Four of the trials,76,85,86,88 including all three of patients with psoriasis,76,85,86 used the DLQI to measure HRQoL. On this measure, participants’ baseline HRQoL was comparable across three of the studies, with mean scores in each study arm ranging from 6.24 to 9.7. 76,85,88 According to the DLQI website,96 these scores indicate a moderate disease effect on patients’ HRQoL. In the remaining trial86 of patients with psoriasis, mean scores were 4.86 and 4.18 in the intervention and control groups, respectively, indicating a small effect on patients’ HRQoL. 96 Participants in this trial therefore had generally experienced less impact on their HRQoL than the participants in the other psoriasis trials. In addition to the DLQI, Matsuoka and colleagues88 used the WHOQOL-26 to measure HRQoL in patients with acne. The authors cite a normative mean score of 3.33 for healthy Japanese women aged 20–29 years, and state that the baseline scores of the participants were similar to this, suggesting that, on this measure, their HRQoL had not been extensively adversely affected by their condition. In the three trials using less common methods to assess HRQoL,74,87,89 the meaning of the baseline scores is unclear, because authors did not provide this information.

Baseline characteristics and baseline scores for outcome measures were generally similar between the intervention and comparator groups in all the trials. Exceptions were that in the RCT by Ersser and colleagues86 there were proportionally more women in the intervention than the control group and that in the Santer and colleagues trial74 POEM baseline scores were slightly higher in the website and website + HCP support groups than the usual care group. In the Bostoen and colleagues trial,76 rates of depression were higher in the intervention group than the control group.

Quality of reporting and methodology of the included trials

The quality of the reporting and methodology of the included trials was generally poor (Table 5), with only two studies86,88 judged not to be at high risk of bias on at least one domain, and all RCTs including at least one domain judged to be at unclear risk of bias, with few instances of low risk of bias. Five trials74,76,85–87 reported adequate random sequence generation, but only one of the seven included trials clearly reported how allocation was concealed and, therefore, the remaining six were judged to be at an unclear risk of bias. Most trials were judged to be at an unclear risk of performance and detection bias, because they did not report if participants, study personnel or outcome assessors were blinded to treatment allocation. Balato and colleagues85 and Staab and colleagues87 were judged to be at high risk of performance bias; in Balato and colleagues,85 although it was noted that physicians were blinded to group assignment until the end of the study, no details were provided about the blinding of participants, and in Staab and colleagues87 it was stated that participants and trainers were not blinded to treatment allocation. The trial by Staab and colleagues87 was also judged to be at high risk of detection bias (on self-reported measures) because participants were not blinded, and it was unclear if the investigators who rated eczema severity were blinded to treatment allocation. However, it may be difficult to blind participants to the fact they are taking part in an educational intervention rather than just receiving standard medical care, but this criterion is still appropriate for demonstrating potential risks of bias.

Incomplete outcome data were adequately addressed in three trials85,86,88 either because all participants completed the trial and were analysed according to their randomised groups,85,88 or because attrition was balanced across arms with similar reasons for drop-out and was therefore considered unlikely to bias the results. 86 One trial74 was rated as being at an unclear risk of bias on this criterion, because, although attrition rates were small and balanced across groups, clear reasons were not reported for the attrition, and, in addition, one participant was randomised and excluded from the analysis because technical difficulties resulted in baseline data not being available for this participant. The other three trials76,87,89 were considered to be at high risk of attrition bias, either because drop-outs were unbalanced between groups76,87 or because there was a high overall rate of attrition89 (with no exact reasons provided other than that participants did not return study measures at particular time points and that four participants in the control group received the intervention and therefore were excluded) and no intention-to-treat (ITT) analyses were used. In addition, one participant in the educational intervention group in Bostoen and colleagues76 was excluded from the analysis owing to experiencing extreme stress at work during the study.

Two trials were assessed as being at low risk of selective reporting, because the authors reported results for all the outcome measurements specified in the methods section of the paper. 85,86 Four were considered to be at an unclear risk of bias for various reasons, including narratively reporting results for many of the outcomes without providing supporting numerical data;76 converting a continuous measure to a dichotomous measure for a severity of itching and scratching outcome;89 reporting within-group p-values for two HRQoL outcomes, with between-group p-values reported for only one of the measures;88 and measuring outcomes at 6 and 12 months’ follow-up, but not reporting the 6-month outcomes. 87 The RCT by Santer and colleagues was considered to be at high risk of selective reporting bias, because results for the IDQoL and CDLQI measures of HRQoL were not reported. 74 Results were also not reported for a number of other measures [specifically, self-report measure of emollient use; Problematic Experiences of Therapy Scale (PETS); attitudes measure; and Patient Enablement Instrument].

Other potential sources of bias were identified in three trials where this was rated as ‘unclear’. In Bostoen and colleagues76 most results were presented as subgroup analyses for atopic dermatitis and psoriasis patients and it was unclear if these were adequately powered or pre-specified. In Ersser and colleagues86 a statistically significant higher proportion of participants in the intervention group compared with the control group were women. In Santer and colleagues,74 there were baseline imbalances in disease severity across groups, with both website groups having slightly more severe disease at baseline than the usual care group, and it was unclear if this had been adjusted for in the data analysis. In Santer and colleagues,74 statistical analyses were also reported inconsistently; specifically, mean change in the POEM score was presented for the combined website groups versus usual care, not individual website groups versus usual care (therefore this result was not data extracted or presented in this review).

Completeness of reporting of the interventions

During data extraction, a modified version of a taxonomy of elements of interventions69 was used to structure how information about the interventions in each trial was recorded. Table 6 shows the elements extracted and whether or not each trial reported details for each. The seven included trials generally provided adequately detailed descriptions of the educational interventions, particularly the content and topics, mode of delivery, providers, materials used and duration and intensity. Few trials explicitly reported the intervention aim, whether the intervention was theory-based, where it was delivered, whether elements were tailored to participants’ needs, the extent to which it was sensitive to participants’ characteristics, the interventionist characteristics and training, or whether ongoing support was provided after the intervention ended.

Statistical issues

All the trials were superiority trials (where the aim is to demonstrate that one treatment is more effective than another). Only two trials76,87 reported power calculations. Despite this, in both it is unclear if the analyses that generated the results were adequately powered. In Bostoen and colleagues76 the results were mainly presented for subgroup analyses of patients with either psoriasis or atopic dermatitis and the power calculation was for the total sample size on an unspecified outcome [note that the subgroup results are presented separately below under each condition-specific section; results for two outcomes [stress and European Quality of Life-5 Dimensions (EQ-5D™) HRQoL measure] were reported for the total group, but only narratively and, therefore, they have not been included in this review]. In Staab and colleagues,87 the analyses of the results for the 3 months to 7 years age group appeared to be adequately powered (power calculation was based on the primary outcome, eczema severity), but it is unclear if the analyses of the results for the 8–12 years and 13–18 years age groups were adequately powered, because fewer participants per group were analysed than the 125 per group calculated as being needed. Three of the studies that did not report power calculations, including two psoriasis studies, were pilot studies. 74,85,86 Overall, with the exception of the analyses of the 3 months to 7 years age group in the Staab and colleagues RCT,87 it is unclear if any of the analyses presented in the trials and included in this review were adequately powered. It should also be noted that all the evidence available for psoriasis was based on either pilot studies85,86 or subgroup analyses. 76

Total attrition rates in five trials ranged from 0% to 26%,74,76,85–88 with four of these74,85,86,88 having no attrition or low attrition rates. The attrition rate in the remaining trial,89 in which the ‘Coping with itch’ programme was delivered to patients with chronic pruritic skin diseases during a median of three clinic visits, was particularly high at 58% overall, with 63% and 51% of patients in the education and control groups, respectively, not completing the trial. None of the trials reported use of ITT analyses, except Santer and colleagues,74 but reviewers note that the analyses in Santer and colleagues74 were not true ITT analyses, as not all randomised carers were included in the analyses. As stated above, the analyses in two trials85,88 can be regarded as ITT, as all patients were analysed according to their randomised groups.

Generally, the trials reported results as point estimates (means) for outcomes in the intervention and control groups, and provided measures of variability around these as either standard deviations (SDs) or 95% confidence intervals (CIs). In a number of instances, findings were reported only narratively, with no supporting numerical data provided (see the results sections for each skin condition in Assessment of effectiveness for specific details of where this occurred). Trials mostly reported the statistical significance of between-group differences, either narratively or by providing p-values. Only two trials86,87 reported CIs around between-group differences. Four of the trials provided some commentary in the publications on the definitions of clinically meaningful change in particular outcomes (specifically, the DLQI,76 PASI,86 SCORAD87 and POEM74), but only two directly applied these definitions to the interpretation of the results in the trial. Of these, one study,74 of the SPaCE website, reported the proportion of children with eczema who had experienced a clinically meaningful improvement in disease severity. The other,87 of a 6-week programme for atopic dermatitis, commented generally on whether the average improvement in disease severity among children and adolescents with atopic dermatitis seen in the study could be considered clinically significant.

Generalisability to UK clinical practice

The majority of the included trials are considered to be of limited generalisability to UK clinical practice, because most were small-scale studies conducted across a range of countries. The largest UK study was Santer and colleagues’74 evaluation of education delivered through the SPaCE website to 149 carers of children with eczema, most of whom were managed in primary care. Reviewers considered this trial to be of good generalisability to patients treated in primary care in the UK, because participants were recruited from 31 general practices and a range of socioeconomic areas. The other included UK study86 was a small pilot study in primary care, conducted in patients with psoriasis. In this study, participants’ baseline HRQoL scores indicated that their psoriasis had had, on average, a small effect on their HRQoL and the participants appeared to have, on average, milder disease at baseline compared with participants in the other psoriasis trials. Given this, it is also of some generalisability to UK clinical practice in primary care and to patients whose condition has had only a small impact on their HRQoL. The large-scale German trial of an educational intervention for children and adolescents with atopic dermatitis and their parents87 could be considered of some relevance to patients with moderate to severe atopic dermatitis seen in secondary care because it was conducted in seven centres with a range of different age groups and should thus capture a wider group of patients. However, the health-care system is likely to be different from the UK. In general, around 50% or more of the patients included in each of the arms of the studies were female, and this is reasonably representative of the chronic inflammatory skin condition populations in the UK. For example, psoriasis tends to affect equal proportions of males and females (see Epidemiology). 17 Acne also affects equal proportions of males and females,25 but the one included study of acne focused exclusively on women aged over 16 years and, therefore, its results may apply only to women in this age group and are unlikely to generalise to men (given that the intervention is, in part, focused on make-up use) or younger adolescents, who are commonly affected by this condition (see Epidemiology). Overall, therefore, the results presented below for educational interventions for children with eczema and their carers are the most generalisable to the UK.

Assessment of effectiveness

Trials of educational interventions for eczema/atopic dermatitis

Summary of clinical effectiveness

Only seven RCTs, with adequately reported results, were identified that evaluated the effects of educational interventions that could improve HRQoL in people with chronic inflammatory skin conditions. Only one study74 explicitly stated in the primary publication that the intervention was aimed at improving HRQoL (but in one other87 the intervention for one of three age groups of participants in the study was based on an intervention of which part of the aim was to improve HRQoL78,93), and only three evaluated theory-based interventions. The current evidence base is mainly limited to small studies (four trials included between 40 to 64 participants; it was unclear if any of these were adequately powered, and one reported subgroup results only and two were pilot studies), of generally poor methodological quality, focusing on psoriasis, atopic dermatitis and acne, and studies including adults. Only two studies included children and adolescents and their parents or carers; these were the largest trials included in the review (992 and 148 randomised participants, respectively, with the smaller study being a pilot study).

The educational interventions have commonly been delivered face to face (either in a group or individually), as an adjunct to standard medical care, and have provided participants with information about their condition and methods for coping with stress or the negative effects of their disease, such as itch or appearance concerns. There have been some attempts to tailor interventions to individual needs or participants’ characteristics. The participants included in the trials generally had had their skin condition for a number of years and no studies were found that specifically targeted newly diagnosed patients. In two of the seven included studies, participants’ mean baseline HRQoL scores indicated that, generally, their disease had had a minimal impact on their HRQoL. Three studies had a follow-up of a reasonable duration to capture the clinical effects of the intervention (≥ 3 months post intervention). Adverse effects were evaluated in only one trial. The majority of the studies were considered to be of limited generalisability to UK clinical practice. Exceptions were the two large RCTs examining the effects of an online educational intervention (the SPaCE website) aimed at the carers of children with eczema in primary care and the group-based educational programme, delivered by a multidisciplinary team over 6 weeks, aimed at children and adolescents with atopic dermatitis and the children’s carers, which was delivered to patients recruited from secondary care. The UK trial by Ersser and colleagues86 of nurse-led education for psoriasis may also have some generalisability to patients seen in primary care whose disease has not extensively affected their HRQoL.

Three trials found statistically significant improvements in HRQoL following the educational interventions. Of these, two found benefits for adult patients with psoriasis at the end of the text message education intervention delivered over 12 weeks and the 3-month, group-based, educational programme intervention delivered by a multidisciplinary team compared with an unspecified control and usual medical therapy, respectively. The other one found benefits for parents of children with atopic eczema at 12 months’ follow-up (it was unclear if this follow-up time point was from baseline or the end of the intervention) from a 6-week group-based programme delivered by a multidisciplinary team compared with a no education control. All these trials also found improvements in patients’ disease severity at these time points. Only one of these psoriasis trials (of the group-based education) measured outcomes in the longer-term post intervention (specifically, 6 months after the end of the intervention) and it found that the improvements on only one of the two HRQoL measures used persisted over time, whereas improvements in disease severity were not maintained. In one of these studies, the same intervention was delivered to patients with psoriasis and patients with atopic dermatitis, but it did not improve HRQoL or disease severity in those with atopic dermatitis despite being effective for psoriasis, and the reasons for this are unclear. It could have been a chance finding, as the results were from potentially under-powered subgroup analyses, which were at unclear risk of bias because it was not stated if these were pre-specified. Of the trials reporting statistically significant improvements in HRQoL and disease severity, only one87 discussed how clinically meaningful the changes were to patients (suggesting that, on average, a meaningful improvement in disease severity had occurred in the children with atopic dermatitis in the trial of the multidisciplinary 6-week programme), but, generally, the clinical significance of the improvements found in these studies is unclear.

No effects of education on HRQoL or disease severity in comparison with usual care were found in studies of a one-off nurse-delivered educational session for adults with psoriasis, instructions on skin care and make-up use to women with acne, the SPaCE website (with or without HCP support) for carers of children with eczema or in a ‘Coping with itch’ programme for participants with a range of conditions delivered in a median of three sessions. It was unclear if any of these studies were adequately powered. However, two were pilot studies, so although they were possibly not powered adequately, they provided useful information about the feasibility and acceptability of the intervention to inform a more rigorous evaluation, as recommended by the MRC guidance on complex intervention development and evaluation. 65 Furthermore, in two studies, participants’ baseline HRQoL scores indicated that their disease had had minimal impact on their HRQOL, which may partly explain the lack of effects (e.g. no room for improvement). The ‘Coping with itch’ study had a high attrition rate, and as no process evaluation was included in the study, it was unclear why so many participants did not complete the study or what programme factors may have led to this.

The review findings also indicate that educational interventions may result in improvements in other outcomes, including decreases in itching catastrophisation, some improvements in coping with itch, reductions in depression and short-term reductions in consultations with HCPs. No impact on medication use was found. The one study that reported adverse effects found no negative impact of the intervention.

It is not possible to determine from the studies in this review the educational intervention components or characteristics that may contribute to improving patients’ and parents’ or carers’ HRQoL. Commonalities between effective interventions were delivery by a multidisciplinary team and delivery over a longer period than the interventions in the trials which did not find any statistically significant effects (ranging from 6 weeks to 3 months). However, given the limitations of the evidence, these commonalities should only be regarded as early indications of factors that may characterise effective interventions.

Overall, the current evidence base suggests that educational interventions including elements that could improve HRQoL do show some promise for improving HRQoL and disease severity in adults with psoriasis directly at the end of the intervention (with some indication that improvements in HRQoL may be maintained 6 months after the intervention, whereas improvements in disease severity may not be maintained), as well as for improving the HRQoL of parents of children with atopic dermatitis, and children and adolescents’ atopic dermatitis disease severity, in the longer term, up to 12 months. There was no evidence of effectiveness on HRQoL in adults with acne or atopic dermatitis or for an intervention aimed at improving itch in a mixed skin diseases population or for an online educational intervention (with or without HCP support) aimed at the carers of children with eczema. Based on the findings of two studies, there are indications that interventions aimed at mixed populations with different skin conditions may not be effective or may be more effective for one of the included patients groups than another. Characteristics of effective interventions may include intensive delivery over a period ranging from 6 weeks to 3 months (rather than shorter, less intensive interventions of one or a few sessions) and delivery by a multidisciplinary team, but, overall, at this stage, it is not possible to identify the intervention factors that may lead to improvements in HRQoL.

Ongoing studies

Six ongoing RCTs were identified that appear to meet the inclusion criteria for the systematic review (Table 22). Three of the RCTs are being conducted in Europe (excluding the UK), two in the USA and one in Japan. According to the study dates specified in trial registries, three of the six RCTs should have been completed, but we have classified these as ongoing trials given that their results have not yet been published.

Three of the RCTs are being conducted with children with atopic dermatitis, although one also includes their parents; one RCT includes adults with psoriasis; one RCT includes adults with psoriasis or eczema; and one RCT includes adults with occupational hand eczema. The interventions are reported to varying levels of detail in trial registries, but appear to consist mostly of various types of group education. Each of the RCTs contains two arms, in which an educational intervention is compared with a comparator. In four RCTs, the interventions are being compared against no education, whereas in two RCTs the comparator is a different type of education. Four of the RCTs specified HRQoL as a primary outcome and two RCTs specified HRQoL as a secondary outcome. The target numbers of patients randomised ranges from 50 to 742. The specified completion dates of the RCTs range from August 2011 to December 2015, although no completion date is specified for the Japanese RCT (see Table 22).

Systematic review of existing cost-effectiveness evidence

The methods of the systematic review are described above (see Inclusion and exclusion criteria), although the inclusion criteria were modified slightly from those used in the review of clinical effectiveness. First, the inclusion criteria for this review were not limited to studies where the effects of education on overall outcomes had to be isolated from effects of any non-educational intervention components that may also be present in the intervention. Second, studies that did not specifically aim to improve HRQoL were also included. The reason for incorporating broader criteria on HRQoL was because the reviewers anticipated fewer studies at the beginning of this review.

The studies are described in terms of their quality and generalisability to the UK and key issues arising from each of the studies are discussed.

Quantity and quality of published research

A total of 1394 citations were identified through the systematic searches. Following examination of titles and abstracts, 13 potentially relevant papers were retrieved for a more detailed inspection. Of these, 10 papers were excluded. The reasons for exclusion were: the nature of the intervention was not educational as defined within the scope of the project;99–102 the study design was inappropriate;75,93,103,104 the study was not published in English105,106 (see Appendix 7). Three studies were eligible for inclusion; one was based on adults with chronic pruritic skin diseases107 and the remaining two studies were on eczema in children. 108,109 In the study on pruritic skin disease, van Os-Medendorp and colleagues107 assessed health-care costs and costs associated with loss of work in patients with different chronic pruritic skin diseases (Table 23) enrolled in the nursing programme ‘Coping with itch’ compared with a control group of patients receiving usual dermatological care. Of the two eczema-based studies, Mason and colleagues108 conducted a cost analysis that examined the effectiveness of an educational support programme to increase emollient use and reduce atopic eczema symptoms in children, whereas Schuttelaar and colleagues109 conducted a cost-effectiveness analysis of care provided by nurse practitioners (NPs) versus dermatologists.

TABLE 23 - Characteristics of economic evaluations

NP, nurse practitioner.

Time horizons of the analyses across the three studies were similar to the trial durations.

Author	van Os-Medendorp et al., 2008107	Mason et al., 2013108	Schuttelaar et al., 2011109
Publication year	2008	2013	2011
Country	The Netherlands	UK	The Netherlands
Study type	Economic evaluation based on the results of a RCT	Cost analysis based on a before-and-after study	Economic evaluation based on the results of a RCT
Perspective	Not reported	NHS	Societal
Study population	Adults with chronic pruritic skin diseases including eczema; atopic dermatitis; pruritus; prurigo; psoriasis; chronic urticaria; other skin disease including allergies, mycosis, fungoides, lichen ruber planus, Darier disease; unknown and non-skin diseases	Atopic eczema (children + carers)	Children with eczema
Intervention(s)	Intervention: nursing care according to the programme ‘Coping with itch’ consisting of educational and cognitive behavioural interventions. It was carried out in a specialised itch clinic run by dermatology nurses who provided individual sessions at the dermatology outpatient department (see also Clinical effectiveness, Results) Comparator: usual dermatologist care	Educational support programme for parents and carers included an educational DVD, online daily diary and telephone helpline with dermatology nurses	Intervention: care provided in terms of education and coaching by a NP Comparator: conventional care by a dermatologist
Key outcome measure	Frequency of itching and scratching as recorded in patient diaries	Emollient use	Between-group differences in the QoL of the child between baseline and follow-up at 12 months measured by IDQoL and CDLQI
Currency base	EUR, currency year not reported	GBP, 2011	EUR, 2008
Time horizona	9 months	3 months	1 year
Baseline cohort	Patients with chronic pruritic skin diseases aged 18 years or older, regardless of the underlying diagnosis, who visited dermatology outpatient departments	Eligible children were male and female, aged 3 months to 6 years, with mild to moderate atopic eczema; and using E45 cream (Reckitt Benkiser, Slough, UK) as their primary emollient	Patients aged ≤ 16 years with a diagnosis of eczema (‘atopic dermatitis’)
Funding source	Dutch College of Health Insurance (CVZ)	Reckitt Benkiser Healthcare	Health Care Efficiency Research Programme of the University Medical Centre Groningen, Groningen, the Netherlands

The study by van Os-Medendorp and colleagues107 was included in the review of clinical effectiveness studies (discussed in Clinical effectiveness, Results), whereas the studies by Mason and colleagues108 and Schuttelaar and colleagues109 were excluded. This was due to the difference in HRQoL inclusion criteria between the two reviews as stated above (see Systematic review of existing cost-effectiveness evidence). In this context, the reviewers deemed the study by van Os-Medendorp and colleagues107 to be the most relevant of the three studies identified through the systematic searches, given that it also met the inclusion criteria for clinical effectiveness. As a result, this study107 is discussed in depth (see Description and results of the published economic evaluations); this is followed by discussion of the remaining two studies108,109 that met the inclusion criteria.

Characteristics of the three included studies107–109 are shown in Table 23 and discussed in more detail subsequently. The identification process of the included studies is shown in a PRISMA flow chart presented in Figure 2. Full data extraction forms for the included studies are included in Appendix 8.

FIGURE 2.

Flow chart of identification of studies for inclusion in the review of cost-effectiveness.

Critical appraisal of the studies

The included studies were assessed against a critical appraisal checklist (Table 24) to evaluate their quality and generalisability to the UK. The checklist was adapted by the review authors from a checklist by Drummond and colleagues. 110 More details of the studies are given below (see Description and results of the published economic evaluations).

TABLE 24 - Critical appraisal checklist for economic evaluations (based on Drummond et al., 2005110)

?, unclear.

The time horizon considered is too short for a chronic disease.

Discounting was not applicable as the time horizon was < 1 year.

Item	van Os-Medendorp et al., 2008107	Mason et al., 2013108	Schuttelaar et al., 2011109
1. Is the decision problem (including interventions compared and patient group) relevant to the UK?	Yes	Yes	Yes
2. Is the setting comparable to the UK?	No	Yes	No
3. Is the analytical and modelling methodology appropriate?	?	?	?
4. Are all the relevant costs and consequences for each alternative identified?	Yes	?	Yes
5. Are the data inputs for the model described and justified?	Yes	?	Yes
6. Are health outcomes measured in QALYs?	No	No	No
7. Is the time horizon considered appropriate?	Noa	Noa	Noa
8. Are costs and outcomes discounted?	Nob	Nob	Nob
9. Is an incremental analysis performed?	Yes	Yes	Yes
10. Is uncertainty assessed?	Yes	?	Yes

All three studies clearly defined the decision problem and used a relevant intervention for the purpose of this review. The nature of the interventions and the comparators varied across the studies. The patient groups of interest were clearly stated in all the studies. Two studies108,109 stated the perspectives adopted. However, there remained uncertainty in the adopted analytical methodologies.

The studies did not incorporate a cost–utility analysis; two studies conducted cost-effectiveness analyses107,109 and the other performed a cost analysis. 108 This was considered as lacking usefulness from the UK NHS perspective, where a cost–utility analysis is generally deemed preferable for decision-making purposes.

Methods for estimating resource use and costs varied. van Os-Medendorp and colleagues107 provided adequate details of all the relevant elements that contributed to the overall costs of both the intervention and comparator strategies. Schuttelaar and colleagues109 described the resource used and costs in a detailed manner. Mason and colleagues,108 however, did not present a detailed overview of all the relevant cost components needed for an accurate estimation of total programme costs.

The studies used different measures to assess outcome. None of the studies reported a preference-based measure of health to estimate effectiveness in terms of QALYs. This is a potential limitation, as having a common numeraire such as QALYs would have facilitated comparison of the effectiveness across different interventions. The quality of the methodology adopted to estimate effectiveness was mixed. Within the two cost-effectiveness analyses conducted in the Netherlands,107,109 effectiveness in terms of HRQoL was assessed through condition-specific measures such as IDQoL and CDLQI109 and disease severity was measured by SCORAD. 109 Clinical outcomes such as frequency of itching and scratching were also estimated107 along with patient satisfaction. The UK-based cost-analysis,108 by contrast, used emollient use, severity of eczema, use of concurrent medication, parent measures and health-care contacts by patients to measure outcomes in the before-and-after study periods.

The economic evaluations conducted within the included studies did not involve extrapolating data beyond study durations. As a result, none of the studies applied discounting as the time horizons were 1 year or less.

Incremental analyses were conducted in all three studies. Uncertainties were assessed by bootstrapping methods in two studies;107,109 it is unclear if these analyses were conducted by Mason and colleagues. 108 Bootstrapping is a technique of resampling statistical data to derive estimates of summary statistics such as CIs and standard errors. The technique makes very limited assumptions about the probability distributions of the data, thereby limiting the introduction of data uncertainty, unlike in probabilistic sensitivity analysis (PSA) as PSA imposes additional assumptions on the real distribution of the data. 111,112 Therefore, even though the studies did not conduct the standard practice of PSA to assess uncertainty, the methods were still considered to be appropriate.

In summary, the included studies lacked detail on some aspects of methodology, making it difficult to assess the validity of the results. Therefore, there is uncertainty on the credibility of the study findings given the limitations outlined above. The study by Mason and colleagues108 is of most relevance to the UK as the health-care system in the study was the NHS.

Future health economic evaluations

This section aims to identify, discuss and address the issues in the current evidence base for educational interventions in chronic skin inflammatory diseases that have emerged in the systematic review of cost-effectiveness studies discussed (see Systematic review of existing cost-effectiveness evidence). The limitations of the current evidence base are discussed first, followed by a list of recommendations and reporting guidelines to be considered for future health-economic analyses of educational interventions in such conditions.

Statement of principal findings

Other relevant factors

Strengths and limitations of the assessment

Uncertainties

There is overall uncertainty about the effectiveness of educational interventions aimed at improving HRQoL in all chronic inflammatory skin conditions, particularly over whether beneficial effects are maintained in the longer term. This is due to the limitations of the evidence base (i.e. studies are generally small, of a poor quality, likely to be underpowered, lack long-term follow-up and there is a lack of consistent evidence for a positive effect on HRQoL). The characteristics and content of educational interventions that may be associated with improvements in HRQoL remain uncertain. The effectiveness of such interventions in rarer chronic inflammatory skin diseases, such as lichen planus, lichen sclerosus and hidradenitis suppurativa, is unknown, as no evidence is available. There are no indications from the evidence reviewed or current clinical guidelines about the best place for such interventions in the clinical pathways for chronic inflammatory skin conditions, about which patients may benefit the most from such interventions, or the settings in which they should be implemented.

Implications for service provision

There is overall uncertainty over whether educational interventions that include components that could improve HRQoL are effective in improving HRQoL and other outcomes among people with chronic inflammatory skin conditions. However, there are some indications of effectiveness in patients with psoriasis and children and adolescents with atopic dermatitis and their carers. Among patients with psoriasis, when used as an adjunct to usual care, text message education improved patients’ HRQoL in the short term at the intervention end compared with an unspecified control condition (based on one RCT), and intensive group-based education delivered over 3 months by a multidisciplinary team improved HRQoL at the intervention end and possibly up to 6 months post intervention compared with medical therapy alone (based on one RCT). Among carers of children with moderate to severe atopic dermatitis, a 6-week, group-based, education programme delivered by a multidisciplinary team may improve their HRQoL in the long term (i.e. up to 12 months), in comparison with no education (based on one large RCT). These interventions also had positive impacts on patients’ disease severity, compared with usual care or the control conditions, with the authors of the trial of education for atopic dermatitis in children suggesting that the average improvements in disease severity found were clinically significant. Other than in this trial, it is unclear how clinically meaningful these improvements are, as authors of these trials did not comment on this. No effective interventions have yet been evaluated for adults with atopic dermatitis or acne, and no evidence exists for rarer conditions or acne in young people.

The best approach to delivering these kinds of interventions is yet to be established and there is much uncertainty around this, but face-to-face, group, sessions or delivery by text messages may be effective. There are some early indications that delivery over a long period (ranging from 6 weeks to 3 months) and delivery by a multidisciplinary team may be associated with positive outcomes. Other than these structural elements, it is not clear what intervention content may be associated with improvements in HRQoL.

Owing to the limitations of the included studies, there is uncertainty over whether educational interventions aimed at improving QoL are cost-effective in the treatment of chronic inflammatory skin diseases.

Suggested research priorities

There is a need for high-quality, adequately powered RCTs in all chronic inflammatory skin conditions, including rarer conditions, in adults, children and adolescents and carers. These should evaluate theory-based interventions that are sensitive to patients’ needs and characteristics, measure adverse events or undesirable effects of both the educational intervention and treatment it is supplementing, and include an adequate long-term follow-up (of at least 3 months post intervention – as recommended by the review Advisory Group – but preferably 12 months or more as these are long-term conditions which require the maintenance of self-care behaviours, disease control and positive HRQoL over time). Ideally, such RCTs should include an economic evaluation, ITT analyses and a process evaluation, define and measure clinically meaningful changes in outcomes, and follow good reporting standards (e.g. the Consolidated Standards of Reporting Trials statement). Ideally, process evaluations should be included and it would be useful to include measures of hypothesised mechanisms and carry out mediation analyses to explore theoretical explanations about how such interventions may work.

Prior to carrying out rigorous RCTs, in line with the MRC guidance on complex intervention development and evaluation, careful intervention development work should be carried out. This could include reviews of existing evidence and theory to define more accurately the theoretical basis of such interventions and what content should be included to help improve HRQoL in chronic inflammatory skin conditions, supplemented by qualitative work with relevant stakeholders, such as patients and HCPs, where needed. For example, investigators could carry out reviews of the factors associated with HRQoL in specific skin conditions to help inform the factors that could be targeted in the intervention to improve HRQoL. Our brief literature review (see Impact of the disease) suggests that psychological distress and stress, along with symptoms, such as itch, and concerns about appearance may negatively impact patients’ HRQoL. 33,39,40 Additionally, the authors of some of the included studies hypothesised that the effects of education on HRQoL may be mediated by improved disease self-management. It could be argued that improved patient activation from education might also increase HRQoL, as it has been found to be associated with improvements in HRQoL in patients in general. 64 These are among the target factors that could be identified in reviews, qualitative work and in consultation with stakeholders, and which then could be considered in the design of future interventions. In particular, our review suggests that there is a paucity of studies of educational interventions that include components addressing the psychosocial issues experienced by people with chronic inflammatory skin conditions, so this may be a useful focus in future educational interventions. Given the paucity of current evidence for this kind of intervention in chronic inflammatory skin diseases, investigators could also draw on evidence about what has been successful in educational interventions for improving HRQoL in other long-term conditions where patients need to self-manage their condition (e.g. diabetes and asthma) when designing interventions. Pilot studies should also be conducted to inform the development of the intervention, its feasibility and acceptability to patients.

RCTs examining the effectiveness of different approaches to intervention delivery would be useful, such as comparing face-to-face sessions or online interventions, or comparing the effectiveness of shorter educational sessions with more intensive programmes or comparing delivery by a multidisciplinary team with delivery by other kinds of intervention providers (e.g. a specialist nurse).

Future studies of educational interventions aimed at improving HRQoL could include measurements of, and clearly report the resources and costs used to deliver, the intervention, to help inform future economic evaluations. It would also be ideal if future economic evaluations used a generic, preference-based measure to assess HRQoL or a disease-specific one that could then be mapped to a preference-based measure.

Contribution of authors

Karen Pickett (Research Fellow) developed the research protocol, contributed to the background section, assessed studies for inclusion, extracted data from and quality assessed included studies, synthesised evidence, drafted and edited the final report.

Emma Loveman (Senior Research Fellow) developed the research protocol, contributed to the background section, assisted in the development of the search strategy, assessed studies for inclusion, extracted data from and quality assessed included studies, synthesised evidence, drafted and edited the final report, project managed the study and acted as guarantor for the project.

Neelam Kalita (Research Fellow) contributed to the background section, assessed studies for inclusion, extracted data from and quality assessed included studies, synthesised evidence and drafted the report.

Geoff K Frampton (Senior Research Fellow) developed the research protocol, assessed studies for inclusion, extracted data from and quality assessed included studies, synthesised evidence and drafted the report.

Jeremy Jones (Principal Research Fellow) assessed studies for inclusion, extracted data from and quality assessed included studies, synthesised evidence and drafted the report.

Publication

Education to improve quality of life of people with chronic inflammatory skin conditions: a systematic review of the evidence. Br J Dermatol. Submitted for publication.

Data sharing statement

All available data are included in the appendices to this report.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health.

Health-related quality-of-life measures

Disease severity measures

Quality criteria (Cochrane ‘risk of bias’ tool) randomised controlled trials

Quality criteria (Cochrane ‘risk of bias’ tool) randomised controlled trials

Quality criteria (Cochrane ‘risk of bias’ tool) randomised controlled trials

Quality criteria (Cochrane ‘risk of bias’ tool) randomised controlled trials