Figure. Patient decision aid treatment options for mild, moderate, and severe psoriasis.
Tan J, Wolfe B. A patient decision aid for psoriasis based on current clinical practice
What can you do to manage your psoriasis? A decision aid for psoriasis
Tan J, Wolfe B. A Patient Decision Aid for Psoriasis Based on Current Clinical Practice Guidelines. Arch Dermatol. 2012;148(6):718-723. doi:10.1001/archdermatol.2012.36
Author Affiliations: Department of Medicine, University of Western Ontario, London (Dr Tan), and Department of Psychology, University of Windsor, Windsor (Ms Wolfe), Ontario, Canada.
Objective To develop a patient decision aid (PDA) for psoriasis with content derived from current clinical practice guidelines.
Design This PDA was developed in accordance with international patient decision aid standards. Primary sources of treatment outcome information were English-language, evidence-based clinical practice guidelines for plaque psoriasis published between January 1, 2006, and December 31, 2010.
Setting Patients with psoriasis from a private practice in Windsor, Ontario, Canada, and a focus group of dermatologists across Canada.
Participants Focus groups of dermatologists (n = 5) and patients with psoriasis (n = 7) were convened to provide feedback on balance, clarity, practicality, and items for inclusion and exclusion.
Main Outcome Measures Physician's global assessment, overall lesional assessment, and 75% reduction in Psoriasis Area and Severity Index.
Results Efficacy measures selected to reflect good control in the PDA were physician's global assessment (clear or almost clear) or overall lesional assessment (none or very mild) for topical agents and 75% reduction in Psoriasis Area and Severity Index for phototherapy and systemic agents. Where available, outcomes for serious adverse effects were displayed figuratively with efficacy measures. Deliberative questions for self-completion and a values clarification exercise were also incorporated.
Conclusion This psoriasis PDA was developed according to international standards based on content derived from current clinical practice guidelines.
Advances in immunobiology have resulted in greater understanding of psoriasis pathogenesis and translated into availability of multiple novel treatments during the past decade. Currently available options for plaque psoriasis include topical therapy (corticosteroids, vitamin D analogues, fixed-dose combinations thereof, and vitamin A analogues), phototherapy (UV-B and psoralen–UV-A), conventional systemic therapy (acitretin, cyclosporine, and methotrexate), and biologic therapy (adalimumab, etanercept, infliximab, ustekinumab, and alefacept).
However, these developments have also been attended by significant challenges for dermatologists and patients in the process of treatment decision making.1 The surfeit of clinical information regarding new treatments requires systematic evaluation, synthesis, and critical appraisal to transform into practical patient care. In addition, the physician-patient relationship has evolved to increased patient participation underpinned by the moral imperative of patient autonomy and informed choice. For diseases such as psoriasis, with multiple treatment options for which outcomes may be uncertain or based on a patient's personal values, there has been increasing recognition of the importance of informed shared decision making. In this model, best medical evidence is applied to individual patient circumstances and guided by patient values and preferences.2 This paradigm is of particular relevance for psoriasis, for which previous studies3,4 of patients with psoriasis have demonstrated widespread dissatisfaction with treatment and their desire for greater support with information on treatment options, clarification of values, access to physicians, and decision-making skills.
A concurrent survey of dermatologists found that decision support was hindered by patient misconceptions about psoriasis, inadequate education materials, patient indecision, and inadequate physician time.5
Patient decision aids (PDAs) are evidence-based instruments to help patients make informed decisions based on individual values about health care options and desired outcomes.6- 8 They are particularly appropriate for complex decisions with multiple treatments but no singular best option.9 These aids can be provided in various formats, including workbooks, decision boards, interactive videos, computer-based programs, audiotapes, pamphlets, and presentations.
Although myriad health PDAs are available (see the Ottawa Health Research Institute Decision Aid Library Inventory at http://decisionaid.ohri.ca/AZinvent.php), none address psoriasis and most are based on binary decisions (ie, choosing one treatment or not) rather than on selecting from more than 10 treatment options, as is the case with systemic options for moderate to severe psoriasis. Our overall objective was to develop a PDA on treatment options to assist patients with psoriasis and their physicians in the process of decision making.
Development of this PDA was in accordance with International Patient Decision Aid Standards criteria.6 The PDA was modeled on the Ottawa Decision Support Framework, which is evidence based and practical and was developed for guiding patients making health decisions. This framework is composed of identification of decision support needs, provision of decision support according to identified needs, and evaluation of outcomes of the process.10 Details on development and evaluation of PDAs, which guided the present PDA, are available elsewhere.7 We have previously published on the needs for decision support on the part of patients with psoriasis and dermatologists, respectively.3,5 In this article, we present the instrument developed for decision support—a PDA. A pilot study for evidence of its effectiveness has been completed and is the subject of a future publication. This study was approved by the research ethics boards of the University of Western Ontario (review 16501E; March 24, 2010) and University of Windsor (review 09-231; December 3, 2009).
Primary sources of treatment information were English-language, evidence-based clinical practice guidelines for plaque psoriasis published between January 1, 2006, and December 31, 2010. Criteria for inclusion were publication in English and high methodologic quality according to Appraisal of Guidelines Research and Evaluation.11 Guidelines that were solely consensus based or represented only expert opinions were excluded. These selection criteria initially yielded 8 guideline publications from 5 different groups: Canadian, German, US, British, and European.12- 20 Additional sources, including systematic reviews and controlled clinical trial publications, were consulted if information from guidelines was inadequate (eg, outcomes related to risk).21 Primary research publications were reviewed where needed for clarification of specific outcome information.
For grading the quality of evidence in this PDA, a 3-category system was used to designate highest to lowest level of evidence. This was signified by stars colored gold (meta-analyses, systematic reviews, and controlled clinical trials), silver (case-control and cohort studies), or white (nonanalytical studies), respectively.
Each of the 2 authors independently extracted and tabulated efficacy outcomes from each of the included guidelines. For discrepancies, sources were reevaluated and consensus achieved by discussion.
Treatment information for inclusion was based on agents and dosages officially approved for psoriasis in Canada and the United States. Efficacy outcomes were based on those reported by guidelines. For consistency across agents, a common measure within each treatment class was selected to reflect at least good control. For topical agents, physician's global assessment (PGA; clear or almost clear) was selected as the outcome measure of interest. In its absence, overall lesional assessment (OLA; none or very mild) was used. For systemic agents, the proportion of patients achieving 75% reduction in Psoriasis Area and Severity Index (PASI-75) was selected because it has been used as a primary outcome measure in clinical trials on systemic treatments for psoriasis during the past decade. In view of the rigor of phase 2 and 3 clinical trial data during a typical treatment course of 12 to 16 weeks in the current era of systemic treatment evaluations, this was the timeframe for efficacy selected for presentation in the PDA. Despite the variability in outcome measures reported for topical compared with nontopical psoriasis treatments, a recent analysis has demonstrated a high level of correlation between a PGA of clear or almost clear and PASI-75.22
For convenience and grouping of outcomes for each agent within a class, relevant information was displayed in tabular form to reflect summaries for each treatment. These summations were not intended to infer comparative outcomes, which are most appropriately evaluated by controlled clinical trials. Tabulation in this manner has precedent in 2 of the current guidelines reviewed.18,19
Display of efficacy metrics in the PDA depended on the reporting in the clinical practice guidelines. Discrete measures reflect specific efficacy data (eg, meta-analyses of identical trial designs for biologics), whereas ranges reflect variations in these reported measures due to different active agents within the same treatment class (eg, topical corticosteroids, vitamin D analogues, UV-B), different outcomes from different guidelines (eg, acitretin, methotrexate), and variation expressed within specific guidelines (eg, cyclosporine).
Guidance in decision making was provided by queries regarding current management satisfaction and preferences regarding treatment modification at the beginning and end of the PDA. An essential feature of a PDA is in clarification of patient values (what the patient perceives as important). Accordingly, a values clarification exercise was incorporated into this PDA based on previous examples in the Ottawa Health Research Institute inventory. This exercise involved patient ratings of the importance of treatment outcomes on a scale of 1 (not important) to 5 (extremely important), including effectiveness, adverse effects, speed of response, costs, ease of use, application, other benefits, and other considerations. Comment boxes under each outcome were provided for patients to expand on their concerns.
Focus groups of dermatologists (n = 5) and patients with psoriasis (n = 7) were convened to provide feedback on balance, clarity, practicality, and items for inclusion and exclusion. Feedback from dermatologists was incorporated into subsequent drafts of the PDA. Two patient focus groups, with 4 and 3 patients, respectively, met for 1.5 hours each. During these sessions, which were led by the second author (B.W.), patients reviewed each page of the PDA and were questioned about acceptability of content (information on psoriasis and treatment options), clarity (portrayal of treatment options and features thereof), and organization (length of PDA and balance of options) using a standard question guide. This guide was developed based on a template for PDA acceptability.10 These sessions were audio-recorded and patient responses were notated. Feedback was incorporated into later drafts of the PDA.
Of the 5 sets of clinical practice guidelines, 2 focused on systemic treatments,18,19 1 of these specifically on biologics,18 whereas the remainder encompassed the spectrum of psoriasis treatments.12- 17,20 A summative portion of the PDA is shown in the Figure, with the entire PDA presented in electronic format (eFigure ). For clinical use, it is anticipated that references would be removed to enhance clarity and brevity.
For topical modalities, the US guidelines on topical treatments were selected as the primary source of information because they provided the greatest detail of outcome metrics.15 Information on PGA outcomes was available within the text of this guideline or from the primary references.23 Although PGA information was not reported for vitamin A analogues, specifically tazarotene, a similar measure, OLA, was available from the original clinical trial publication.24 However, only proportions achieving OLA grades of none or very mild were selected because these outcomes approximated a PGA of clear or almost clear. Thus, 2 primary research articles were reviewed to provide further detail on outcomes.23,24 German guidelines20 provided information on one potency class of corticosteroids and tazarotene, whereas Canadian guidelines12 reviewed the spectrum of topical agents but did not provide numeric metrics of efficacy.
For phototherapy, the most specific information on outcomes was provided by the European19 and US guidelines.17 In both, complete clearance rates and PASI-75 were reported for psoralen–UV-A and narrowband UV-B.
The efficacy of conventional systemic agents, including acitretin, cyclosporine, and methotrexate, was obtained from the European, US, and German guidelines.16,19,20 For biologic agents, proportions achieving PASI-75 were obtained directly from the British and US guidelines.14,18 A range for PASI-75 was provided in the PDA for those modalities in which efficacy data were presented in that manner and if there were variances between guidelines, specifically, PASI-75 values for UV-B,19,20 acitretin,16,19,20 cyclosporine,19,20 and methotrexate16,19,20 (darker green faces were used for the lower limit, whereas lighter green faces were used for the lower to upper limit).
Current guidelines were inadequate in providing specific metrics on the rate of serious adverse events. Only the European guidelines subdivided risk based on frequency (very frequent, frequent, occasional, rare, and very rare). However, these categories were subjectively determined and not evidence based (Berthold Rzany, ScM, written communication, November 20, 2009). A meta-analysis of serious adverse events for systemic agents was available that provided event rates for the conventional oral agents methotrexate and cyclosporine (but not acitretin) and the biologics etanercept, infliximab, and adalimumab (but not alefacept and ustekinumab).21 Because the trial durations for studies reviewed in that analysis were limited to 16 weeks or less, their findings may not be valid for longer durations. For purposes of this PDA, however, which restricted information on benefit and risk to the initial 16 weeks, the monthly risk rates were compounded to provide an absolute number for that duration (shown as red faces in the PDA).
The International Patient Decision Aid Standards criteria met by this PDA are given in the Table. This PDA meets 15 of the 15 content criteria for treatment, 9 of the 9 development criteria, and 0 of the 2 effectiveness criteria. In a pilot study involving 10 patients with psoriasis (J.T. and B.W., unpublished data, November 2011), acceptability of this PDA was rated as good to excellent for each element of content, clarity, length, balance, and suitability.
This PDA was developed according to international standards of development.6 Currently, there are 26 criteria on which PDAs for treatment are assessed.6 Although this PDA fulfilled all content and development criteria, it did not fulfill the 2 for effectiveness. Achieving the latter would best be achieved with a randomized controlled trial.
Patients with psoriasis desire information about all treatment options for their condition.3 Accordingly, the spectrum of available US- and Canadian-approved options was listed in the PDA along a continuum of increasing treatment intensity from mild to severe psoriasis, a strategy reflective of the overall management of psoriasis espoused in recent clinical guidelines.6,8- 10 This summary provided brief descriptions of the 4 primary treatment modalities (ie, topicals, phototherapy, conventional oral agents, and biologic injections), specific examples, the appropriate target group, those with relative or absolute contraindications, and special situations requiring additional consideration (eg, pregnancy, breastfeeding, and psoriatic arthritis). This prelude to the in-depth risk and benefit information on specific treatment classes and respective agents was designed to provide information on the spectrum of treatment options, while contextualizing treatment options based on severity. For example, patients with severe psoriasis who had previously tried topical treatment with little success would appropriately then be directed to more intensive treatment modalities (eg, phototherapy, conventional systemic agents, or biologics).
Treatment content in this PDA was unique in incorporating recommendations from the most recently published, evidence-based clinical practice guidelines on psoriasis. In view of their high methodologic quality,11 they represent the most comprehensive and systematically developed resources available for translation of clinical evidence to patient information for psoriasis. Furthermore, the multiple guidelines developed by 5 different groups provided a means of cross-referencing content on treatment outcomes. Wherever possible, these clinical practice guidelines served as the primary source for specific benefit and risk outcomes. Nevertheless, there were multiple challenges in condensing and collating the myriad sources of information into a comprehensible, succinct, and practical tool for patients. Guidelines provided outcome information in varying extremes—from one providing almost no numerical values12 to another reporting means and 95% CIs.18 Although dermatologists use objective criteria for efficacy assessments, patients are focused on more subjective concerns. In particular, none of the current clinical guidelines provided treatment efficacy from the perspective of patient-reported outcomes. Currently, information is sparse on how best to translate these dissimilar perspectives.25 Furthermore, efficacy measures used for topical agents, one of the most commonly used treatment classes, differed from that used for phototherapy and systemic agents. To maintain conservative efficacy estimates and to reflect the subjective nature of the patient perspective, we selected the descriptive phrase “good control” in the PDA to reflect the different efficacy measures for topicals (PGA and OLA) and systemic agents (PASI-75). Finally, the advent of new treatment options, efficacy for longer durations, and monitoring for emergent adverse effects require ongoing vigilance. Accordingly, the information provided in this PDA is counterweighted by the time of information embargo of the guidelines in this review. Additional limitations of this PDA include restriction to treatments for which evidence was available in clinical practice guidelines, the relatively short duration of consistently available outcome metrics at 12 to 16 weeks, and the potential for limited accessibility for certain options due to reimbursement considerations (biologics) or inadequate facilities (phototherapy).
To assist patients unfamiliar with medical decision making, this PDA included specific means to facilitate their involvement, including queries regarding current management satisfaction and preferences for treatment modification. These questions were revisited after treatment options were presented to direct patients throughout the process. Furthermore, patients were then asked to consider and document their preferred treatment options in the PDA and to consider reasons for their choices. This deliberative process was a concerted effort to facilitate decision making systematically. The values clarification exercise of this PDA differentiates it from a purely informational brochure because it requires personal reflection and consideration of specific factors important to the individual. It also provides a means to articulate their values and concerns regarding treatment and potential outcomes. Formalizing these factors may facilitate further physician guidance by directing patients to options congruent with their expressed values and preferences.
The Ottawa framework10 selected for the development of this PDA was based on the need for an evidence-based and practical template for guiding patients in making health decisions. This framework has been applied to the development of multiple PDAs for diagnosis and treatment, including those listed in the Cochrane Musculoskeletal Group (see http://musculoskeletal.cochrane.org/decision-aids). Unlike most of those, however, which address single options and binary decisions, this PDA presents the spectrum of available treatment options.
This PDA can be used anytime patients desire treatment (if not treated) or are reconsidering treatment (if being treated). As a stand-alone resource, the PDA can inform psoriasis patients about their condition, determine the severity of their condition, and contextualize treatment options. Optimally, however, we envision that it be used by patients with guidance from their physicians. Physicians may pare treatment options initially (and thereby shorten the PDA) based on medical contraindications specific to the patient, treatment availability, and treatment accessibility. Treatment accessibility is particularly relevant for biologics in jurisdictions where eligibility for drug coverage is regulated and requires demonstration of specific criteria for severity and lack of efficacy, intolerance, or contraindication to conventional systemic options. On a subsequent visit after its completion, the PDA would then inform physicians of values and preferences of the individual patient to facilitate further treatment personalization. The PDA can be shortened by selecting only those pages relevant to the decision (eg, unnecessary sections may include conventional systemic and biologic agents for patients with mild psoriasis and topicals for patients with severe psoriasis).
Recognition of the imperative of patient-centered research, whereby the latter is informed by patient perspectives, interests, and values in decisions about prevention, diagnosis, and treatment, was recently underscored by establishment of the Patient-Centered Outcomes Research Institute by the US Congress through the Patient Protection and Affordable Care Act in 2010.26 The PDA presented herein represents convergence of advances in medical therapeutics and in health psychology on patient-centered research. In particular, we present this PDA as a means of achieving informed shared treatment decision making integral to patient-centered care.
Correspondence: Jerry Tan, MD, FRCPC, 2224 Walker Rd, Ste 300, Windsor, ON N8W5L7, Canada (email@example.com).
Accepted for Publication: December 30, 2011.
Published Online: May 21, 2012. doi:10.1001/archdermatol.2012.36
Author Contributions: Dr Tan and Ms Wolfe had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Tan and Wolfe. Acquisition of data: Tan and Wolfe. Analysis and interpretation of data: Tan and Wolfe. Drafting of the manuscript: Tan and Wolfe. Critical revision of the manuscript for important intellectual content: Tan and Wolfe. Obtained funding: Tan. Administrative, technical, and material support: Tan and Wolfe. Study supervision: Tan.
Financial Disclosure: Dr Tan has been an adviser, clinical investigator, and speaker and/or received grants or honoraria from Abbott, Allergan, Amgen-Wyeth, Astellas, Biogen, Centocor, Fujisawa, Galderma, Isotechnika, Janssen-Cilag, Leo, Novartis, OrthoBiotech, Pfizer, Schering, and Serono.
Funding/Support: This study was funded by a Canadian Dermatology Foundation grant.
Additional Contributions: We acknowledge the following dermatologists: Ben Barankin, MD, Robert Bissonnette, MD, Wayne Gulliver, MD, Harvey Lui, MD, and Neil Shear, MD. Decision aid expert Dawn Stacey, RN, PhD, provided feedback during the development of this decision aid.