Strengths
l Thorough searches of a range of literature databases were conducted for both the clinical and cost- effectiveness reviews, including the Global Resource for Eczema Trials (GREAT) database which contains all atopic dermatitis RCTs and systematic reviews. Additionally, the reference lists of included studies and relevant systematic reviews were searched and experts were asked about studies of which they were aware. This means that the review is unlikely to have missed relevant studies.
l The systematic reviews were conducted in line with good practice principles of conducting systematic reviews in health care.120
l The review methods were set out in a protocol prior to the start of the review and published on the PROSPERO website (PROSPERO reference number: CRD42014007426).
l Both the development of the protocol and the project were informed by an Advisory Group including clinicians, researchers in the field and patient representatives.
l The use of a taxonomy of intervention elements69during data extraction to ensure that detailed information about the content and characteristics of the educational interventions was included in the review and to help evaluate the completeness of reporting of the intervention characteristics in the included studies.
l The systematic reviews of both the clinical effectiveness and cost-effectiveness studies have been carried out independently of any vested interest and the results of both the reviews are presented in a consistent and transparent manner.
Limitations
l Owing to the nature of the intervention and to many of the studies retrieved for full-text screening not explicitly reporting the aims of the interventions, the reviewers found it challenging to infer if the interventions were aimed at improving HRQoL or could improve HRQoL, in accordance with the review inclusion criteria. Therefore, this was sometimes a judgement call and there was some disagreement between pairs of reviewers, which was resolved through arbitration by a third reviewer. To resolve these disagreements, reviewers considered whether the interventions included elements that targeted compliance with therapy or patients’ ability to cope with the negative effects of the chronic skin disease, as per the examples given in our a priori inclusion criteria. As mentioned above, this highlights that what defines such interventions generally needs more consideration and theorising in the
literature. We consider our approach satisfactory, given that intervention aims were not well reported and given the lack of definition of these kinds of interventions in the literature.
l Meta-analysis could not be conducted owing to heterogeneity of studies and interventions and the limited evidence-base for each skin condition.
l The review was limited to English-language studies only.
l When determining if a HRQoL or patient-reported outcome measure was validated, the reviewers relied on statements in the included publications that these were validated and, if this was not reported, they then checked the general literature to see if a measure met at least one validation criteria. Therefore, some measures included were more validated than others. However, the studies used a range of commonly used and well validated measures in this area, such as the DLQI and PASI, so this is likely to be only a minor issue in the review.
l Outcomes for the end of intervention and longest follow-up period only were data extracted in this review, owing to limited resources and time and consideration that the longest follow-up time point would be the most informative. Given the episodic nature of skin diseases and impact of seasonal changes, however, it may have been useful to data extract interim time points too.
l The main focus of this review was on the effect of educational interventions that aim to, or could, improve HRQoL. As such, the data presented on other outcomes from education, such as improved disease severity, are drawn only from studies of this particular type of education and, therefore, do not represent all data on how these outcomes may change following patient education in general for chronic inflammatory skin conditions.
l Three studies of educational interventions that aimed to or could improve HRQoL were excluded from the review for not reporting results in sufficient detail to be informative. Owing to time and resource limitations for the review, we were unable to contact study authors to request them to provide the missing information.
l Length of follow-up of the studies included in the cost-effectiveness review was inadequate to assess the long-term costs and outcomes of educational interventions in patients with chronic inflammatory skin diseases.
l There were a number of limitations in the evidence base for the cost-effectiveness of educational interventions, including limited information, lack of relevant HRQoL measures and information on costs and resources and, as such, we were able only to make recommendations for future economic
evaluations rather than undertake a de novo economic model.
This review builds on previous systematic reviews of RCTs of educational interventions for chronic
inflammatory skin conditions55,71,121through its focus on those interventions that specifically aim to improve HRQoL or those that include aspects which could improve HRQoL. In line with the other reviews of
educational interventions in general, we found that some studies showed statistically significant positive impacts on HRQoL and other outcomes, whereas some did not. Therefore, even when considering only interventions that focus on some way on HRQoL, it is still uncertain from the evidence if educational interventions for people with chronic inflammatory skin conditions can improve HRQoL. Ersser and colleagues71suggested from a review of educational interventions in children with atopic dermatitis that nurse-led or multidisciplinary interventions may be the most effective in improving outcomes. In our review, we similarly found that delivery by a multidisciplinary team was a commonality between the effective interventions in comparison with those that were not effective.
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.