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15th October 2024
The use of shared decision-making in dermatology is varied despite a desire for it to be embedded into routine clinical practice in the UK. A recent retrospective, single-site study explored the extent to which shared decision-making was documented in medical records for those undergoing immunosuppressant treatment for a dermatological indication.
The King’s Fund’s 2011 publication ‘No decision about me, without me’ noted that the Government wants shared decision-making to become the norm in the NHS.1
There have been various definitions of shared decision-making over the years. Guidance from the National Institute for Health and Care Excellence (NICE) defines it as ‘a joint process in which a healthcare professional works together with a person to reach a decision about care’.
In general, shared decision-making involves choosing tests and treatments based on evidence and the person’s preferences, beliefs and values. Discussion and information sharing ensure that the person understands the risks, benefits and possible consequences of the available options.
This joint process empowers people to make decisions about their care that are right for them at that time, with the options of choosing to have no treatment or not changing what they are currently doing always included.2 Shared decision-making is most appropriate when more than one reasonable option is available, with trade-offs between potential benefits and harms.
Other than when there may be time-challenging acute contacts with patients, it is argued that all significant healthcare decisions should be based on a dialogue that incorporates both the healthcare professional’s experience and expert knowledge of illness and health, as well as the patient’s experience, values and preferences for their own lives.3 Patients are no longer seen as passive recipients in healthcare, and healthcare professionals are not transmitters.3
The General Medical Council (GMC) Decision making and consent guidance notes that all patients have the right to be involved in decisions about their treatment and care and to make informed decisions, if they can. It also states that the exchange of information between clinician and patient is essential to good decision-making.4
In addition, Good medical practice guidance for all GMC-registered doctors highlights the need to support patients in making decisions about treatment and care and sharing information with patients.5
Within the NHS in England, the NHS Standard Contract includes Service Condition 10 on Personalised Care, which states: ‘In planning and reviewing the care or treatment which a service user receives, the provider must employ shared decision-making, using supporting tools and techniques approved by the co-ordinating commissioner.’
Furthermore, shared decision-making is driven by the duties of NHS England to promote individual participation in decisions about care, treatment, tests and prevention of illness; promote patient choice; and exercise its functions to secure continuous improvement in the quality of services.6
Dermatology is a specialty particularly suited to shared decision-making as the severity of most dermatologic diseases is defined by patients’ experiences of symptoms and adverse psychosocial impact.7
A shared decision-making approach in dermatology has been described in several publications across different countries and conditions.8-10 A survey assessing the extent of shared decision-making in atopic dermatitis and psoriasis in the Netherlands found that despite the dermatologists’ optimistic perspective, patients experienced a limited extent of shared decision-making.9
At Royal Cornwall Hospitals NHS Trust, we wanted to ascertain the extent to which shared decision-making is documented in medical records as having occurred for patients who commenced an immunosuppressant for a dermatological indication.
Royal Cornwall Hospital is a 750-bed acute teaching district general hospital in the south-west of England. The dermatology unit provides routine and emergency assessment, treatment and surgery for patients with skin conditions and diseases.
In conditions for which an immunosuppressant would be prescribed, the patient is typically referred from primary care, sees a senior dermatology doctor and then attends a nurse-led clinic for any baseline tests and education on the treatment. The first prescription for the treatment is usually provided through the outpatient pharmacy.
This was a retrospective, single-site study in an acute teaching district general hospital.
A convenience sample of patients prescribed one of the three target oral immunosuppressants (azathioprine, ciclosporin or methotrexate) from dermatology was identified by searching the outpatient dispensing database (see Table 1).
Table 1. Patient characteristics of those prescribed target immunosuppressants
We used the NICE shared decision-making guideline,2 choosing prompts from section 1.2 to formulate our questions, having decided not to include information relating to whether:
The date of initial dispensing for a specific patient was used to search for any correspondence to the GP or patient on our patient administration system. Such correspondence was examined for any text relating to the questions in Table 2. The patient characteristics of gender, age and indication for treatment were also recorded. Data were entered and analysed in Microsoft Excel.
Table 2. Questions arising from NICE shared decision-making guidance
Health Research Authority criteria for research and service evaluation were considered. This was a retrospective assessment involving no changes to the service delivered to patients, and we used the NHS Health Research Authority tool, which helped confirm that no ethical approval was required for this project.
Patient data were used in accordance with local NHS hospital policy, and this assessment was recorded on the Trust’s clinical effectiveness database.
We reviewed the correspondence records for 30 patients from late 2021 to early 2024 (see Table 2 above).
Only in a minority of patients (n=3) was there documented evidence that different available options had been shared with the patient. Overall, in 19 of the 30 cases, it was documented that there were different treatments in the pathway, although the correspondence typically described prior treatments tried or possible future treatments in the pathway rather than expressing how the patient was helped to choose between possible options.
For three of the 20 patients with eczema who were commenced on either azathioprine, ciclosporin or methotrexate, one of the alternative options was named in the correspondence as having previously been tried. In one further case, methotrexate was restarted.
In only three of the remaining 16 cases of eczema was an alternative drug – other than what was prescribed – named in the correspondence as having been mentioned to the patient. For the four psoriasis patients on methotrexate, only prior treatments were documented in the correspondence.
For all 30 cases, a treatment review period was noted. In nearly two-thirds of instances, the correspondence explicitly provided a dermatology department telephone number, although contact details for the hospital switchboard would have been in the letter.
We found that some aspects of the NICE shared decision-making recommendations were documented in correspondence to a greater extent than others. Our study found that 26 patients (87%) were given a British Association of Dermatologists leaflet; this would have been after the medication choice had been made.
This leaflet is not a decision aid, as patient decision aids go beyond standard brochures, educational pamphlets or websites by describing evidence, helping patients think about their preferences and identifying steps to support a decision.10 Furthermore, NICE advises offering a resource before a discussion to encourage the patient to think about what matters to them, what they hope will happen as a result of the discussion and what questions they would like to ask.2
We found that in nearly two-thirds of correspondence, different options in the treatment pathways were mentioned. However, this usually describes what has previously been used or what might be a future treatment. There were only three cases when it was documented that different options had apparently been explained to the patient.
Hence, for this cohort of 30 patients, it is unclear how the decision to commence a specific drug – such as the decision between ciclosporin or azathioprine in eczema – is reached and what, if any, patient input there is into this decision.
It may be that the choice is influenced by prescriber experience and familiarity and not after a person-centred discussion. However, any clinical bias that does exist when suggesting options to patients, though possibly based on personal experience or familiarity, may not necessarily be a bad thing if the drugs are similar in effectiveness and risks.
If shared decision-making is to be embedded into practice, there should be consideration of how choosing between the three treatment options for eczema mentioned above, for example, can become more formalised for both the prescriber and the patient. Principles of how such a decision aid might be constructed are reported in the published literature.11
Decision aids are effective strategies for improving shared decision making between people and their health professionals.12 Examples in dermatology include those for actinic keratosis,13 although one scoping review, with a search strategy up to 2020, reported there have been few published and validated decision aids in dermatology.14 That review also argues for the exploration of the reluctance of dermatologists to include shared decision-making in their practice.
We recognise some limitations with this small-scale study. Some aspects of the shared decision-making process may have happened in the patient consultation but were not documented. Furthermore, the choice of a specific immunosuppressant will also be based on patent-specific factors such as co-morbidities that may not be detailed in the correspondence. For example, someone with a high alcohol intake may not be offered methotrexate. These factors may mean that there is, in effect, only one drug to choose.
This small study identified varying degrees of documentation for some critical aspects of shared decision-making for dermatology patients.
To support shared decision-making, an information leaflet highlighting the differences and contraindications of the three drugs, including their benefits and risks, could be given by the clinician to all patients so they can read through it in their own time before a treatment decision is made. This might improve the patient experience, but it might also confuse some patients and reduce satisfaction in those with poor or limited health literacy.15
Alternatively, such a leaflet could be offered to all but given selectively to patients who wish to have a more active role in choosing the drug to be prescribed. However, it is unclear now how this extra step would fit into the workflow of a busy department without causing undue delay in instigating treatment.
Michael Wilcock MPhil
Pharmacy Department
Ersa Tsoutsoura MPharm
Dermatology Department
Lisa Haddon MBBS BSc MRCP
Dermatology Department
All of Royal Cornwall Hospitals NHS Trust, Truro, UK
22nd June 2023
Use of a ceramide-containing cleanser and lotion significantly reduces the localised adverse effects of a retinoid-benzoyl peroxide gel used to treat acne, according to a recent randomised, placebo-controlled trial.
It was suggested in 1995 that an impaired water barrier function in the skin due to reduced amounts of ceramides may be responsible for the formation of acne lesions. Topical retinoids combined with benzoyl peroxide represent an effective treatment regime for acne. However, the combination is association with localised adverse effects characterised by burning, itching, tightness and dryness. Some evidence suggests that changes to the composition of the vehicle for acne medications, enhances tolerability.
Since a more tolerable vehicle might reduce skin irritation and possibly enhance treatment adherence, in the current study published in the Journal of Drugs in Dermatology, researchers performed a double-blind study was to measure the impact of acne treatment on skin barrier function when paired with a ceramide routine.
Participants using an adapalene and benzoyl peroxide (A/BPO) gel for the treatment of their acne, were recruited and randomised to an intervention or placebo group. The intervention group received a ceramide-containing foaming facial cleanser and facial lotion whereas the placebo group received basic foaming face wash, both of which were for twice-daily use. Participants applied the A/BPO gel once daily and self-reported measures of skin irritation. Both transepidermal water loss (TEWL) and the efficacy of A/BPO were also assessed.
A total of 91 participants completed the study, of whom 45 were in the ceramide arm.
Among those using the ceramide routine, TEWL was significantly lower after four weeks of treatment and remained so for all 12 weeks of the study (p < 0.05). Measures of skin dryness and scaling were significantly improved in the ceramide group after one week (p < 0.05), whereas erythema was only significantly improved at week four. Overall, a higher proportion of the intervention group reported having less skin dryness, tightness and that their skin felt more comfortable throughout the duration of the study.
The total mean count of inflammatory lesions was significantly lower after four weeks in the intervention group and this was maintained thereafter until week 12 (p < 0.05). However, there were no significant differences in the mean non-inflammatory lesion counts.
The authors concluded that while a topical A/BPO gel caused damage to the skin barrier, the associated symptoms such as irritation could be significantly reduced through the use of a ceramide routine.
Topical roflumilast is being increasingly trialled for a number of skin conditions but how effective is it, and will it take centre stage in the field of dermatology? Rod Tucker investigates.
Oral roflumilast is licensed for maintenance treatment in severe chronic obstructive pulmonary disease. Its mode of action relates to the suppression of inflammation, but this benefit extends far beyond respiratory diseases.
Roflumilast inhibits the enzyme phosphodiesterase 4 (PDE4), which hydrolyses cyclic adenosine monophosphate (cAMP), a secondary messenger within cells that is involved in many biological processes in the body. With research suggesting that higher levels of cAMP supress inflammation, PDE4 inhibitors effectively suppress the production of inflammatory markers.
PDE4 inhibitors have become a promising class of drugs with a potential role in a number of therapy areas such as pulmonary, dermatological and neurological diseases. To date, there are two further PDE inhibitors available: apremilast, which is an established oral therapy for psoriasis, and crisaborole, a topical agent used to treat atopic eczema.
But how effective is topical roflumilast in the management of skin diseases?
Topical roflumilast 0.3% has gained gained FDA approval for use in patients with plaque psoriasis. In the two trials leading to FDA approval, disease severity was assessed by a score of ‘clear’ or ‘almost clear’ and a two-point improvement on the Investigator Global Assessment (IGA) scale. This endpoint was achieved by 41.5% and 36.7% of patient treated with topical roflumilast compared to 5.8% and 7.1% with placebo.
In addition, roflumilast has also been found to significantly improve symptoms of scalp psoriasis. But, an added bonus for the drug, is that it is also effective and approved for psoriasis affecting intertriginous sites. Management of intertriginous, or inverse, psoriasis, is a therapeutic challenge, as noted by a recent systemic review which concluded that there is a lack of good quality evidence upon which to base treatment recommendations.
Although clinically distinct from psoriasis, seborrhoeic eczema is associated with an inflammatory milieu characterised by several cytokines. In a recent phase 2a, double-blind, vehicle-controlled trial, researchers investigated the efficacy of a roflumilast 0.3% foam in patients with the condition. Participants assigned to roflumilast saw significant improvements in the IGA score (73.8%) compared the the vehicle group (40.9%), and there were also signification reductions in pruritus.
PDE4 inhibition is also a potentially valuable target in atopic eczema, as demonstrated by crisaborole, which is a proven effective treatment. However, a recent turn of events has provided the manufacturer of topical roflumilast, Arcutis Biotherapeutics, with a distinct advantage in the topical treatment of atopic eczema, particularly in Europe.
In the UK, NICE has not provided a recommendation for the use of Pfizer’s crisaborole in atopic eczema, after the manufacturer withdrew its evidence submission. Similarly, in 2022, the marketing authorisation for crisaborole in the EU was withdrawn. As a result, the drug, is not recommended in the 2022 European guidelines on the management of atopic eczema.
Nevertheless, the position adopted by the UK and EU is in sharp contrast to the US, where the most recent iteration of the American Academy of Dermatology guidelines on atopic eczema do include a recommendation to use crisaborole.
Although roflumilast now has an advantage over crisaborole in the European market, initial findings for the drug in atopic eczema were disappointing. The results of a phase 2 proof-of-concept trial using two strengths of the drug (0.15% and 0.05%) found that neither strength improved Eczema Area and Severity Index (EASI) scores compared to the vehicle cream.
In contrast, the most recent data are more encouraging. In an abstract that combined two phase 3 trials in patients with atopic eczema, those assigned to roflumilast 0.15% cream achieved a significantly higher treatment success (p < 0.0001) compared to vehicle in both trials.
Arcutis Biotherapeutics appears to have great ambitions for its drug. Some work with the PDE4 inhibitor apremilast, demonstrated an ability to control the progression of vitiligo. Moreover, given that vitiligo is mediated via oxidative stress and that roflumilast is able to reduce oxidative stress, the drug may also be of value in this condition.
In preliminary work, it was shown that roflumilast enhanced melanin synthesis when combined with forskolin, a cAMP stimulator, but only exhibited a slight influence on melanogenesis when used alone. Although this indicates a potential role in vitiligo, which is reflected on the manufacturer’s website, this is not an active area of research.
Finally, with evidence from a trial demonstrating that apremilast improved disease severity in papulopustular rosacea, a trial of roflumilast in facial papulopustular rosacea is currently recruiting patients.
There is now mounting evidence to suggest that topical roflumilast has the potential to make an important impact on the treatment landscape of psoriasis, seborrhoeic and atopic eczema and possibly rosacea. But exactly where the drug might sit in the treatment ladder for these conditions is uncertain given the absence of studies with active comparators.
Nonetheless, any effective addition to the clinician’s therapeutic armamentarium in the fight against skin diseases is to be welcomed. With Arcutis Biotherapeutics having only just begun its journey with topical roflumilast, it remains to be seen whether the drug will ultimately achieve the status of a dermatological panacea.
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