Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema
- By: Kim Thomas
Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema. BMJ 2012;345:e7822, doi:10.1136/bmj.e7822 by Kristina Sophie Ibler and colleagues
Objective—To evaluate the effect of a secondary prevention programme with education on skin care and individual counselling versus treatment as usual in healthcare workers with hand eczema.
Design—Randomised, observer blinded parallel group superiority clinical trial.
Setting—Three hospitals in Denmark.
Participants—255 healthcare workers with self reported hand eczema within the past year randomised centrally and stratified by profession, severity of eczema, and hospital. 123 were allocated to the intervention group and 132 to the control group.
Interventions—Education in skin care and individual counselling based on patch and prick testing and assessment of work and domestic related exposures. The control was treatment as usual.
Main outcome measures—The primary outcome was clinical severity of disease at five month follow-up measured by scores on the hand eczema severity index. The secondary outcomes were scores on the dermatology life quality index, self evaluated severity of hand eczema, skin protective behaviours, and knowledge of hand eczema from onset to follow-up.
Results—Follow-up data were available for 247 of 255 participants (97%). At follow-up, the mean score on the hand eczema severity index was significantly lower (improved) in the intervention group than in the control group: difference of means, unadjusted −3.56 (95% confidence interval −4.92 to −2.14); adjusted −3.47 (−4.80 to −2.14), both P<0.001 for difference. The mean score on the dermatology life quality index was also significantly lower (improved) in the intervention group at follow-up: difference of means: unadjusted −0.78, non-parametric test P=0.003; adjusted −0.92, −1.48 to −0.37). Self evaluated severity and skin protective behaviour by hand washing and wearing of protective gloves were also statistically significantly better in the intervention group, whereas this was not the case for knowledge of hand eczema.
Conclusion—A secondary prevention programme for hand eczema improved severity and quality of life and had a positive effect on self evaluated severity and skin protective behaviour by hand washing and wearing of protective gloves.
Why do the study?
This study, by Ibler and colleagues, is a randomised controlled trial looking at the secondary prevention of hand eczema in healthcare workers. The topic is important because hand eczema in healthcare workers causes considerable morbidity for affected individuals and is extremely common, largely because of the need for frequent hand washing as part of infection control initiatives.
If occupational hand eczema could be prevented or minimised through the introduction of a simple and cost effective health education programme, this would be an important health message for healthcare providers worldwide.
The trial focused on the secondary prevention of hand eczema, in that the investigators wanted to prevent or minimise exacerbations in healthcare workers who already had hand eczema. This is different from primary prevention programmes, which are designed to prevent new cases of hand eczema in individuals who are at risk—that is, all healthcare workers—before symptoms appear.
The objective of the study was to evaluate the effect of a secondary prevention programme, which included skincare education and individual advice, compared with standard care alone in healthcare workers with self reported hand eczema.
To date, most research has focused on the primary prevention of occupational hand eczema, so this study is a useful addition to the literature and may encourage healthcare providers to consider targeted education programmes aimed at workers most likely to benefit.
What did the authors do?
Healthcare workers with self reported hand eczema were identified using a survey sent to all members of staff at three hospitals in Denmark (n=3181). A standardised question was used to identify responders with hand eczema, and a good response rate of over 70% was achieved. From these responses, 397 (20%) healthcare workers reported some degree of hand eczema and were invited to take part in the trial; 255 agreed to do so). This information is important as it helps the reader to understand how applicable trial results are to the wider community.
Once potential participants had been identified, they were enrolled into an observer blind, randomised controlled trial, whereby the trial participants knew what intervention they were randomised to (which is nearly always the case for a behavioural intervention such as this). As a result, special efforts were required to ensure that the primary outcome for the trial was assessed by someone who did not know the treatment allocation. In this case, eczema severity was assessed using a validated scale to assess eczema on the hands.
Research has shown that three things are associated with risk of bias in clinical trials: inadequate methods of randomisation, inadequate concealment of treatment allocation, and inadequate blinding. Against these criteria, the current study performed well. Blinding of the outcome assessment was secured by an independent assessor, randomisation was performed and managed through an independent clinical trials unit, and treatment allocations were not released until participants’ details had been irrevocably entered into the study database. All of these items are clearly described in the study paper in accordance with the latest CONSORT guidance for the reporting of clinical trials.
Another important characteristic of a well conducted trial is preregistration on an approved trial registry and publication of the trial protocol before analysis, thus ensuring transparency of trial reporting and reduced risk of outcome reporting bias.  This does not mean that changes to the protocol cannot happen during a trial, but any changes need to be declared and reasons for the change explained. In the case of the current trial, a change was made to the timing of the primary outcome from six months to five months as the investigators wanted to “avoid confounding from spontaneous improvement of eczema from increased exposure to ultraviolet radiation” from sunlight. This would seem to be an odd decision and one that might have been calculated to maximise any difference between the two groups in the primary outcome assessment. Whether this was sufficient to change the overall conclusion of the trial is difficult to say, but it does suggest that longer term follow-up should be included in any future trials of this kind so that long term treatment effects can be explored.
The intervention used in the active treatment arm of the trial had several components. Participants were first patch tested for common allergens. This information was then used to provide tailored advice on how best to avoid relevant allergens, coupled with information on how to protect their skin while at home and at work. Demonstrations on hand washing and the application of emollients were given, and participants were advised to wear gloves for wet tasks, to avoid wearing rings, to use disinfectants in place of hand washing, and to use an emollient at least three times a day. This advice is in line with current clinical guidelines for prevention of occupational hand dermatitis. Studying a complex intervention such as this presents several methodological and reporting challenges. Firstly, it is important to standardise the intervention across the different recruiting hospitals and from one individual to the next. This was achieved through the use of a standardised protocol and written advice for all participants. Secondly, it is difficult to establish which individual components of the intervention are critical to its success. As a result the package must be implemented as a whole and should be described in sufficient detail for others to be able to replicate the trial findings and to put the intervention into current practice. It is not clear from this trial, for example, whether or not individual patch testing is needed for the success of this intervention, or whether non-specific advice about allergen avoidance and best practice skin care alone would be equally effective. 1
What did the study find?
Overall, the study found a 3.5 point reduction in the severity of the eczema for the intervention group compared with normal care, as assessed by independent assessors masked to treatment allocation. Although this might sound like a relatively small difference, this effect was statistically significant (95% CI −4.94 to −2.14; P<0.001) and is close to the difference that the study was originally powered to detect. Since most participants had mild hand eczema at baseline (median at baseline: 9 points), the results should be interpreted in this context. Other secondary outcomes including self reported eczema severity, quality of life, and use of skin protective behaviours were also in line with the primary outcome (although knowledge of hand eczema was not significantly improved).
What are the strengths and limitations of the study?
This was a well conducted trial that adhered to current best practice in the design and conduct of randomised controlled trials. It was clearly reported and pragmatic in approach, and presented results that have the potential to change practice.
The trial reported high uptake rates for those approached to enter, suggesting a genuine desire for the intervention among healthcare workers. Similarly, loss to follow-up was extremely low (3%), further strengthening the credibility of the trial findings.
The potential for contamination of the control group (via the intervention group explaining the intervention to the control group) was a serious risk as participants were recruited from just three hospitals. However, simply asking participants not to discuss the advice given with other members of staff was apparently successful in limiting contamination, as significant health benefits were observed in participants allocated to the prevention strategy.
As is common with many eczema trials, the primary outcome for the study was an objective scale with a theoretical range from zero to 360 (the hand eczema severity index). This means that interpretation of the clinical relevance of the primary outcome is unclear. Nevertheless, the small improvements seen on this objective eczema severity index were reflected in the severity scores assessed by the patients, suggesting a meaningful benefit to participants.
What does the study mean?
Healthcare providers and managers should take note of this trial when developing health and safety policies for their staff. The provision of a programme for the prevention of hand eczema might be a suitable strategy for reducing of occupational dermatitis in this population.
Further trials are required to confirm these findings, to assess outcomes over a longer timeframe, and to evaluate the cost effectiveness of prevention programmes such as this.Kim Thomas, associate professor
1Centre of Evidence Based Dermatology, University of Nottingham, UK
Correspondence to: Kim.firstname.lastname@example.org
Competing interests: None declared.
Provenance and peer review: Commissioned; not externally peer reviewed.
- Ibler KS, Jemec GBE, Diepgen TL, Gluud C, Lindschou J, Winkel P, et al. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised controlled trial. BMJ 2012;345:e7822.
- Bauer A, Schmitt J, Bennett C, Coenraads PJ, Elsner P, English J, et al. Interventions for preventing occupational irritant hand dermatitis. Cochrane Database Syst Rev 2010;6:CD004414.
- Held E, Skoet R, Johansen JD, Agner T. The hand eczema severity index (HECSI): a scoring system for clinical assessment of hand eczema. A study of inter- and intraobserver reliability. Br J Dermatol 2005;152:302-7.
- Savović J, Jones HE, Altman DG, Harris RJ, Jüni P, Pildal J, et al. Influence of reported study design characteristics on intervention effect estimates from randomized, controlled trials. Ann Intern Med 2012;157:429-38.
- Schultz KF, Altman DG, Moher D, the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel-group randomized trials. Trials 2010;11:32.
- Chan AW, Hróbjartsson A, Haahr MT, Gøtzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291:2457-65.
- Nankervis H, Baibergenova A, Williams HC, Thomas KS. Prospective registration and outcome reporting bias in randomised controlled trials of eczema treatments. J Invest Dermatol 2012;132:2727-34.
- Smedley J, Williams S, Peel P, Pedersen K, on behalf of the Dermatitis Guideline Development Group. Management of occupational dermatitis in healthcare workers: a systematic review. Occup Environ Med 2012;69:276-9.
Cite this as: Student BMJ 2013;21:f800
- Published: 01 March 2013
- DOI: 10.1136/sbmj.f800