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Economic evidence for the prevention and treatment of atopic eczema: a protocol for a systematic review

Abstract

Background

Eczema, synonymous with atopic eczema or atopic dermatitis, is a chronic skin disease that has a similar impact on health-related quality of life as other chronic diseases. The proposed research aims to provide a comprehensive systematic assessment of the economic evidence base available to inform economic modelling and decision making on interventions to prevent and treat eczema at any stage of the life course. Whilst the Global Resource of Eczema Trials (GREAT) database collects together the effectiveness evidence for eczema, there is currently no such systematic resource on the economics of eczema. It is important to gain an overview of the current state of the art of economic methods in the field of eczema in order to strengthen the economic evidence base further.

Methods/design

The proposed study is a systematic review of the economic evidence surrounding interventions for the prevention and treatment of eczema. Relevant search terms will be used to search MEDLINE, EMBASE, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, National Health Service (NHS) Economic Evaluation Database, Health Technology Assessment, Cumulative Index to Nursing and Allied Health Literature, EconLit, Scopus, Cost-Effectiveness Analysis Registry and Web of Science in order to identify relevant evidence. To be eligible for inclusion studies will be primary empirical studies evaluating the cost, utility or full economic evaluation of interventions for preventing or treating eczema. Two reviewers will independently assess studies for eligibility and perform data abstraction. Evidence tables will be produced presenting details of study characteristics, costing methods, outcome methods and quality assessment. The methodological quality of studies will be assessed using accepted checklists.

Discussion

The systematic review is being undertaken to identify the type of economic evidence available, summarise the results of the available economic evidence and critically appraise the quality of economic evidence currently available to inform future economic modelling and resource allocation decisions about interventions to prevent or treat eczema. We aim to use the review to offer guidance about how to gather economic evidence in studies of eczema and/or what further research is necessary in order to inform this.

Systematic review registration

PROSPERO CRD42015024633

Background

In the UK, the lifetime prevalence of eczema is estimated to be between 16 and 20 % making it the commonest inflammatory skin condition in children, and it has been increasing in “western style” environments [13]. In the UK, the age-sex standardised incidence and lifetime prevalence of eczema has increased between 2001 and 2005 from 9.58 per 1000 to 13.58 per 1000 patients and 77.78 per 1000 to 115.26 per 1000, respectively [4]. Up to 50 % of childhood cases will experience recurrence in adulthood [2]. Eczema is largely managed in primary care. Skin conditions are the commonest new reason patients consult their GP [5]. Eczema has been found to have a similar impact on health-related quality of life as other common childhood conditions such as asthma and diabetes [6]. Eczema impacts quality of life by causing itching, sleep loss and social stigma for the child. Families may also suffer from sleep loss and time taken off work to accompany children to health appointments [7]. The condition is associated with atopy so children with the condition are more likely to develop asthma and allergic rhinitis [8]. It is also believed that eczema has large cost implications. For instance, in 1995–1996, the total annual UK cost of eczema in children aged 5 years or younger was estimated as £47 million (£80 per child) [9]. Looking at a broader age range, the UK total annual cost was estimated to be around £465 million, of which £125 million were National Health Service (NHS) costs, £297 million costs incurred by patients and £42 million by society in terms of lost productivity (price year not reported) [10]. These UK-based estimates of the total annual UK costs of eczema are now dated, the estimates were based on small samples [146 in [10] and 1523 in [9]], and the range of treatments available has increased and is likely to increase in the future with the addition of new biologics [11].

Despite eczema being common, there remain many unknowns about how to prevent and treat the condition. The James Lind Alliance (JLA) [12] Priority Setting Partnership (PSP) on eczema illustrates this (http://www.jla.nihr.ac.uk/priority-setting-partnerships/eczema and [13]). The JLA facilitates disease specific PSPs that bring together patients, carers and health professionals to identify and prioritise research for the treatment uncertainties of the disease of interest (http://www.jla.nihr.ac.uk/). The eczema PSP was established in 2010 with partners drawn from academic, NHS and charitable sectors and resulted in 14 treatment uncertainties being prioritised [13].

In order to draw together the effectiveness evidence of interventions for eczema, the Global Resource of Eczema Trials (GREAT) [14] database was established [15] and includes details of over 600 systematic reviews and randomised controlled trials. It does not, however, identify or bring together the economic literature on eczema, and thus, this review attempts to do this. There is likely to be less economic evidence, compared to effectiveness data, for eczema. Indeed, the English National Institute of Health and Care Excellence (NICE) has only considered economic models for two areas of eczema care: an educational intervention for those with eczema aged under 12 [16] and tacrolimus and pimecrolimus for atopic eczema [17]. It is, therefore, important to identify the current state of economic evidence addressing eczema in order to inform the design of future economic research in the area.

The proposed systematic review will address the following four research questions:

  1. 1.

    What type of health economic evidence has been used in the evaluation of the prevention and treatment of atopic eczema?

  2. 2.

    Are interventions to prevent and treat atopic eczema cost effective?

  3. 3.

    What is the quality of the health economic evidence for the prevention and treatment of atopic eczema?

  4. 4.

    What are the current gaps in the existing research?

Methods/design

Protocol and registration

The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement recommendations were used to develop the methods for this systematic review (see Additional file 1) and will be used in reporting the results from the study [18]. This protocol has been registered in the International Prospective Register of Systematic reviews (PROSPERO) CRD42015024633. Should protocol amendments be necessary, these will be documented including details of the date, changes made and the rationale for changes.

Literature search

The following electronic databases will be searched: MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, Cochrane Database of Systematic Reviews, NHS Economic Evaluation Database, EconLit, Scopus, Health Technology Assessment, Cost-Effectiveness Analysis Registry and Web of Science. There will be no restriction imposed on the search from date; therefore, the literature search will go from the earliest records within each database, to the single day that the search was conducted on. Search results will be downloaded to Endnote version X7 where duplicates will be identified and removed.

Reference lists of potential eligible studies, reviews, guidelines or other sources will be screened for additional literature. Authors of published abstracts and conference proceedings will be contacted by email to establish if a full paper has since been published in the grey literature.

The search strategy was guided by The Cochrane Collaboration Handbook [19] and the Centre for Reviews and Dissemination guidelines for systematic reviews [20]. Specifically, search terms used in other atopic eczema systematic reviews were used to inform the clinical search terms [21]) and were also informed by the clinical author on the paper: NL. The economic terms were similarly devised, by consulting relevant guidelines [22, 23]. The complete search strategy (with interface and coverage dates) is available in the Appendix to this protocol.

Eligible studies

A study will be included if it reports primary data on cost and/or outcome (utility or willingness to pay) data on atopic eczema. The primary interest is in full economic evaluations (cost effectiveness, cost utility, cost benefit and cost minimisation) although other partial economic evidence will also be included where the study has an explicit economic objective, this is likely to include cost-consequence analyses, cost analyses, utility assessment or willingness to pay/accept studies. There will be no restriction on the study designs used in the economic studies so, for example, economic studies conducted alongside randomised controlled trials, as part of observational studies, or as decision model-based analyses will be included. Nor will there be any restrictions on type of setting. The search was undertaken on the 9th October 2015, so only studies published before this date are included. Only full text articles published in the English language will be included, abstracts and letters will be excluded. Where two or more studies appear to be reporting on the same dataset or using the same model, the most comprehensive paper will be included unless each paper reports on a different aspect or in relation to a different jurisdiction/population (in the case of modelling studies).

Data collection

Study selection

Two independent reviewers will assess the titles and abstracts retrieved in the literature search against our inclusion criteria. In a second stage, full-text articles for those seeming to fit the criteria or where there is uncertainty about relevance will be retrieved and their eligibility assessed according to criteria set out in Table 1. Where disagreements occur a third reviewer will be involved.

Table 1 Inclusion and exclusion criteria

Data abstraction and management

Data will be extracted independently by two reviewers and entered into an electronic data extraction form developed in Microsoft Excel, with the third reviewer consulted in case of disagreements that cannot be resolved between the two reviewers. A full list of the extraction fields can be found in Table 2. The data extraction form was piloted, modified (where necessary) and reviewers’ responses calibrated on the basis of two pre-identified studies (one modelling study and one non-model-based paper). The data extracted will be analysed in a narrative/descriptive manner focusing on the methods, results and quality of studies included with the aim of identifying gaps in the evidence, areas of strength and areas in need of methodological improvement.

Table 2 Data abstraction fields

If the necessary data are available, the results will be discussed as subsets for different age groups (e.g. child/adult/elderly) and/or different skin disease severities and/or world regions and/or health-care settings. Furthermore, as it is expected that included studies will report results in a range of currencies, where possible, results will be reported in the original currency and price year, as well as being converted to UK pounds using the purchasing power parities provided by the Organisation for Economic Co-operation and Development (OECD), inflating to a common price year using the consumer price index, to facilitate the comparison of results across studies.

Quality assessment and data presentation

Two reviewers will independently evaluate the quality of included studies in order to assess the risk of bias. Studies will be assessed using a published checklist based on a modified version of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) framework [24] (see Table 3). In addition, model-based economic evaluations will also be assessed using the Phillips criterion [25, 26] (see Table 4 for extraction table). Any discrepancies will be discussed and resolved by a third reviewer.

Table 3 CHEERS checklist [24]
Table 4 Philips criterion [25, 26]

To initially assess the quality of included studies, a score of 1 will be given to items within the CHEERS checklist that can be answered ‘yes’, 0.5 for items only partially addressed, 0 for ‘no’ and where an item is identified as not applicable, no score will be given. The score will then be totalled and calculated as a percentage of the total score that could be achieved for that study, thus taking into account elements of the checklist which were deemed not applicable. This is an approach that has previously been used [27], and although it is acknowledged that by assigning equal weighting to each criteria may not truly reflect the importance of each of the checklist items, it is thought that it will provide a broad overview of the quality of studies included, which will then pave way for more detailed analysis on individual checklist items. These evaluations will be included in any publication as supplementary material where feasible.

Methodological variation between studies is likely to prevent a pooling of economic data in the form of a meta-analysis, and therefore, results of the studies will be presented and discussed in a qualitative manner according to the study type.

Discussion

This systematic review will provide a comprehensive assessment of the type and quality of economic research used in the evaluation of interventions to prevent and treat eczema. The results of the review are likely to be written up in multiple publications, one focusing on an overview of the state of the art with additional papers focusing in more detail on particular methodologically aspects (for instance, the methods used in modelling studies). The review will report the range of cost-effectiveness estimates found for interventions to prevent and treat atopic eczema, which may be useful in informing clinicians and decision makers about the relative value of different interventions for eczema and enable the value of eczema interventions to be compared with the cost effectiveness for other interventions in other disease areas. That is, it may help decision makers, on the basis of current information (if sufficient), to be able to answer questions about how to allocate limited resources between eczema and other disease areas and once allocated to eczema how to use those limited resources efficiently to maximise outcomes from eczema care. The review will also be of interest to methodologists interested in the range and quality of economic studies in this clinical field. Finally, this systematic review will help identify gaps in the current evidence base surrounding the economics of eczema to inform further research efforts in this area.

Abbreviations

CHEERS:

Consolidated Health Economic Evaluation Reporting Standards

GP:

General Practitioner

GREAT:

Global Resource for Eczema Trials

HQoL:

Health-Related Quality of Life

ICER:

Incremental Cost Effectiveness Ratio

JLA:

James Lind Alliance

NA:

Not Applicable

NHS:

National Health Service

NICE:

National Institute of Health and Care Excellence

PSP:

Priority Setting Partnership

QALYs:

Quality Adjusted Life Years

UK:

United Kingdom

References

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Acknowledgements

This systematic review is independent research arising from Tracey Sach’s Career Development Fellowship (CDF-2014-07-006) supported by the National Institute for Health Research. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.

The following individuals are acknowledged as providing advice as research mentors (Professor Kim Thomas, Dr Nicky Welton, Professor Andrew Briggs) and as part of the annual advisory panel (Dr Tom Kenny, Dr Nick Levell, Fiona McOwan, Jo Parris, Amanda Roberts, Professor Lee Shepstone, Professor Fujian Song and Dr Edward Wilson).

Authors’ contributions

TS conceptualised the research plan for the proposed systematic review and wrote the manuscript. EM and CM contributed to the writing of the manuscript. NL provided expertise on eczema. All authors reviewed the manuscript for important intellectual content and approved the final manuscript. TS is the guarantor.

Competing interests

The authors declare that they have no competing interests.

Author information

Correspondence to Tracey Helen Sach.

Additional file

Additional file 1:

Preferred Reporting Items for Systematic review and Meta-Analysis Protocols (PRISMA-P) 2015 checklist: recommended items to address in a systematic review protocol. (DOCX 15kb)

Appendix

Appendix

Details of electronic bibliographic database search strings

Medline (1946 to present) & Embase (1974 to present) (via Ovid, http://ovidsp.tx.ovid.com/)

  1. 1.

    (dermatitis or eczema).tw.

  2. 2.

    exp Eczema/

  3. 3.

    exp Dermatitis, Atopic/

  4. 4.

    exp Economics/

  5. 5.

    exp Quality‐Adjusted Life Years/

  6. 6.

    exp Health Care Costs/

  7. 7.

    (econ* or cost* or price* or expenditure* or "pharmacoecon*" or budget* or "value of life" or qaly* or "quality adj* life year*" or utilit* or pricing* or "net benefit*" or "monetary benefit*" or "net health benefit*" or "willingness to pay" or "fee*” or “charge*").tw.

  8. 8.

    1 or 2 or 3

  9. 9.

    4 or 5 or 6 or 7

  10. 10.

    8 and 9

Web of Science (various indexes included earliest start date 1970 to present) (http://apps.webofknowledge.com)

  1. 1.

    TS=(dermatitis or eczema)

  2. 2.

    TS=((econ* or cost* or price* or expenditure* or "pharmacoecon*" or budget* or "value of life" or qaly* or "quality adj* life year*" or utilit* or pricing* or "net benefit*" or "monetary benefit*" or "net health benefit*" or "willingness to pay" or "fee*” or “charge*"))

  3. 3.

    1 and 2

EconLit (1886 to present) and CINAHL (1937 to present) (via EBSCO, http://web.a.ebscohost.com)

  1. 1.

    MH "Dermatitis, Atopic" OR MH "Eczema"

  2. 2.

    AB Dermatitis OR Eczema

  3. 3.

    (MH "Economics+") OR (MH "Health Resource Allocation") OR (MH "Health Care Costs+") OR (MH "Health Care Delivery+") OR (MH "Quality Adjusted Life Years") OR (MH "Quality of Life") OR (MH "Economic Value of Life")

  4. 4.

    AB econ* or cost* or price* or expenditure* or "pharmacoecon*" or budget* or "value of life" or qaly* or "quality adj* life year*" or utilit* or pricing* or "net benefit*" or "monetary benefit*" or "net health benefit*" or "willingness to pay" or “fee*” or “charge*”

  5. 5.

    1 or 2

  6. 6.

    3 or 4

  7. 7.

    5 and 6

Scopus (1960 to present) (http://www.scopus.com)

  1. 1.

    (TITLEABSKEY (dermatitis OR eczema)) AND (TITLEABSKEY ((econ* OR cost* OR price* OR pricing* OR expenditure* OR "pharmacoecon*" OR budget* OR "value of life" OR qaly* OR "quality adj* life year*" OR utilit* OR "net benefit*" OR "monetary benefit*" OR "net health benefit*" OR "willingness to pay" OR "fee*” OR “charge*")))

Cochrane Database of Systematic Reviews/Database of Abstracts of Reviews of Effect/Cochrane Central Register of Controlled Trials/Health Technology Assessment Database/NHS Economic Evaluation Database (all years searched)

(via Wiley, http://onlinelibrary.wiley.com/cochranelibrary/search/)

  1. 1.

    dermatitis or eczema.ti.ab

  2. 2.

    MeSH descriptor: [Dermatitis, Atopic] explode all trees OR MeSH descriptor: [Eczema] explode all trees

  3. 3.

    econ* or cost* or price* or expenditure* or "pharmacoecon*" or budget* or "value of life" or qaly* or "quality adj* life year*" or utilit* or pricing* or "net benefit*" or "monetary benefit*" or "net health benefit*" or "willingness to pay" or "fee*” OR “charge*".ti.ab.

  4. 4.

    MeSH descriptor: [Economics] explode all trees OR MeSH descriptor: [Quality Adjusted Life Years] explode all trees OR MeSH descriptor: [Health Care Costs] explode all trees

  5. 5.

    1 or 2

  6. 6.

    3 or 4

  7. 7.

    5 and 6

CEA Registry (1976 to present) (https://research.tufts-nemc.org/cear4/Home.aspx)

  1. 1.

    Eczema

  2. 2.

    Dermatitis

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Keywords

  • Eczema
  • Economics
  • Costs
  • Health-related quality of life
  • Cost effectiveness

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