FormalPara Key Points

Patient-reported outcomes provide clinically relevant information, giving insight into how skin conditions affect dermatology patients.

Patient-reported outcomes can be broadly implemented into routine dermatologic practice. We encourage and provide recommendations to assist dermatologists when considering whether to implement patient-reported outcome measures in their practices.

1 Introduction

The Institute of Medicine’s 2001 report on patient-centered care shifted medical decision making to optimizing patient outcomes and identifying what matters most to patients [1]. Patient-reported outcome measures (PROMs) help quantify the patient's voice during the clinic visit [2]. PROMs are validated survey instruments that offer insight into multiple aspects of a patient’s health-related quality of life (HRQL), such as itch, pain, mental health, physical functioning, sleep interference, and self-esteem.

Dermatologic care aims to improve skin-related morbidity, including HRQL. Patients have reported that dermatologists have “poor comprehension of the psychological implications of skin diseases” and are “insensitive to their patients’ emotional suffering” [3]. The psychological morbidity from skin disease is associated with the patient’s, not the clinician’s, assessment of severity [4].

PROMs are often questionnaires, scales, or single-item measures, either via paper-and-pencil or electronically. PROMs can function as a baseline from which clinicians can monitor improvement with treatment, side effects, or flares. This opinion piece seeks to discuss how to overcome barriers to dermatologists incorporating PROMs into routine patient-centered care and describe some of the many validated general and dermatology-specific PROMs from an ever-growing pool, enumerating their distinctive features, licensing information, and where each can be found. We hope this knowledge empowers dermatologists to identify and implement PROMs in their clinical practice to complement clinical care.

2 Methods

We provide a sample of the most used PROMs relevant to dermatology identified through the MEDLINE database and consulting dermatologists who actively use PROMs in clinic. A current list of available PROMs and how to access them can be found on the Dermatology PRO Consortium website: https://www.dermproconsortium.org/pro-list. We welcome additions to this list.

3 Benefits of Patient-Reported Outcome Measures (PROMs) in Clinical Care

PROMs have improved clinical decision making and informed patient–clinician interactions in several clinical areas, including oncology [5], orthopedic surgery [6, 7], acute care [8], heart failure [9], and opioid addiction [10]. In cancer patients, PROM use improved survival by about 6 months by identifying and addressing symptoms earlier to prevent further harm [5]. PROMs provide a patient-centered perspective on treatment effectiveness and the importance of clear skin in dermatology [11, 12]. For example, isotretinoin clinically meaningfully improves HRQL as measured by Skindex-16 [13]. PROMs can also help determine if prescribed medications are working properly (from the patient’s perspective) or causing significant side effects [14].

PROMs provide patients with a structured method to share more with clinicians than might be said otherwise. In a review of 42 PROM studies, patients did not “feel it was appropriate to discuss emotional, functional or [HRQL] issues with doctors, and doctors did not perceive this was within their remit” [15]. Thus, patients can have potentially treatable issues that go unaddressed because of a lack of communication. Finally, web-based PROMs for symptom surveillance with cancer patients are cost effective and decrease follow-up cost [16, 17].

In dermatology, dozens of PROMs have been developed and validated across several skin diseases and symptoms. Because these capture the patient’s voice as to the effects of their skin disease (and its treatments) on HRQL, PROMs could serve as a vital sign in dermatology that is patient-derived, quantifiable, and can be consistently measured [18, 19]. PROMs help patients communicate their concerns to a clinician rapidly and systematically [15]. However, the evidence base for clinical significance of dermatology PROMs is currently lacking; more studies are needed on the value of PROMs in dermatology practice, but calls for routine use are gaining momentum. The European Academy of Dermatology and Venereology (EADV) Quality of Life Task Force’s 2016 expert-opinion statement tasked dermatologists to adopt PROMs for routine use in clinical practice and treatment decisions [20]. However, selecting an appropriate PROM for clinical use can be challenging.

4 Overview of Psychometric and Practical Properties

A key barrier to the routine clinical use of PROMs for assessing skin disease impact is establishing an accurate and reliable measure that can be meaningfully interpreted [21, 22]. PROMs comprise a series of items, the responses to which can be translated into a score that indicates patient-reported outcomes, such as current symptom severity or HRQL. In addition to being valid, reliable, and responsive, a clinical PROM should be brief, interpretable, accessible, and actionable [22].

Validity is an assessment’s capacity to measure what it is supposed to measure and not measure what it is not supposed to measure [21]. A valid PROM should be developed using a qualitative framework of interviewing patients and clinicians to determine how best to capture the desired input (symptoms, HRQL, etc.). Validity can also be assessed by testing a new measure against an available ‘gold standard.’ In the US, the Patient-Reported Outcomes Measurement Information System (PROMIS) is a collection of well-validated PROMs developed using National Institutes of Health funding [23], and these have been validated with reviews by expert panels, patient interviews, and clinical validity evidence [24]. More PROMIS domains are being developed, and relevant PROMIS domains can be tailored to the needs of dermatology patients (e.g., PROMIS Itch [24,25,26,27,28]).

Reliability is an assessment’s ability to provide consistent scores over time, meaning that the same patient will answer in the same way if they are clinically unchanged [21]. PROMIS measures have been tested for reliability [29,30,31,32]. Also, both Skindex and the Dermatology Life Quality Index (DLQI) have high internal consistency [33,34,35,36], which assesses whether a patient responds similarly to similar questions [21]. For example, a patient who strongly agrees that their skin itches should also agree that their skin symptoms bother them. For routine clinical use, a trade-off exists between high reliability and the need for shorter assessments to decrease survey fatigue [24]. Some PROMs are transitioning to computer-adaptive tests (CATs). CATs tailor additional questions drawn from a large item bank based on individual responses to prior items and refine an individual’s score, often with fewer questions [37,38,39].

Responsiveness refers to an assessment’s ability to identify changes over time [21]. For PROMs to adequately assess treatment effectiveness, they should show improvements or worsening of symptoms or HRQL in response to treatment [21]. In a study comparing DLQI, Short Form 36 (SF-36), and EuroQOL 5D (EQ-5D), DLQI was most responsive to changes in psoriasis treatments [36]. Additionally, acne patients receiving isotretinoin are more affected mentally than physically, and changes over time can be observed using Skindex-16 [13].

The minimal important change (MIC) of a PROM supports interpretation of clinical significance. MIC helps distinguish between clinically significant (clinically meaningful) and statistically significant differences [40]. MICs have been reported for only a few dermatology measures, including Skindex [41,42,43] and DLQI [44].

Importantly, many PROMs have not been validated in diverse populations and age groups. Small differences in wording can influence interpretation. Children and individuals with special needs may require additional consideration in that PROMs should be designed and validated for these groups or for a proxy (e.g., a parent).

Finally, it is important that PROMs are practical for clinical use [22]. Specifically, PROM scores should be actionable, prompting clinicians to further testing, treatment adjustments, or referrals. A high depression screening score can prompt a referral to a mental health specialist [45]. Worsening PROM scores can prompt a recommendation to switch from topical to systemic agents for psoriasis or acne. An ideal PROM for clinical use will also be freely available for administering electronically or via paper-and-pencil.

5 Selecting the Best PROM(s) for Your Clinical Practice

Of hundreds of existing PROMs, this opinion piece summarizes key features of some widely used general and dermatology-specific (Table 1), skin disease-specific (Table 2), and symptom-specific PROMs (Table 3). These measures vary greatly in purpose (e.g., HRQL vs symptom assessment), clinical utility, number of questions, time to complete, and accessibility. We recommend only using PROMs that assess aspects relevant and useful to understanding the dermatology patient’s condition and thereby informing medical decision making.

Table 1 Examples of general health-related and dermatology-specific PROMs
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Table 2 Examples of disease-specific PROMs
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Table 3 Examples of symptom-specific PROMs
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Some clinicians might find a more general assessment tool (Table 1) more clinically useful, as they address a broader variety of concerns, including both physical and mental health, fatigue, social isolation, pain, etc. [46, 47]. These measures provide insight into a person’s overall health, but lack specificity as to which aspects are impacted by their skin condition.

Dermatology-specific measures (Table 1) assess a range of concerns related to or affected by a patient’s skin condition. Two measures commonly used in clinical trials and epidemiologic research are DLQI and Skindex-16. In 10 questions, DLQI measures symptoms and feelings, daily activities, leisure, work/school, personal and sexual relationships, and treatment [48]. Children’s DLQI focuses on how skin issues affect schooling and bullying and removes the question about sex [49]. Skindex-16 provides an intuitive score on a 0–100 scale, with 100 representing maximal impact on HRQL, for each of three domains: (1) symptoms, (2) emotional impact, and (3) functional impact [50]. In clinical practice, most dermatologists at University of Utah Health (UUH) reported difficulty interpreting DLQI’s non-intuitive scoring [51].

For those in specialized dermatology clinics (e.g., atopic dermatitis, psoriasis), disease- or symptom-specific PROMs (Tables 2, 3) may provide additional disease-specific insight for chronic skin conditions with specific symptoms or effects. For example, the patient-oriented eczema measure (POEM) measures symptom frequency and severity in adult and pediatric atopic dermatitis patients [52, 53]. An app called My Eczema Tracker can track POEM scores and eczema severity, akin to glucose tracking apps for diabetes patients, to help identify triggers and eczema flares and help clinicians offer personalized treatment recommendations [52].

6 Additional Considerations in Optimizing PROM(s) for Your Practice

Clinicians who desire to use PROMs in dermatology clinics need to balance the information gained without taking too much clinic time or causing survey fatigue. Longer assessments lead to lower response rates [54]. However, PROMs vary on both the content and relevance of the questions [54], and patients are willing to complete longer PROMs when they see their value and relevance [55]. Skindex-Mini, with three questions, was developed specifically to balance the need for dermatology-specific information with minimal patient burden and may be feasible for integration into the American Academy of Dermatology’s (AAD) DataDerm [56, 57].

Clinicians should consider timing of PROM collection, determining when a PROM score will be most useful. For example, all new patients to UUH Dermatology are sent an email asking them to complete PROMs online in the week prior to their initial visit. Patients who have not done so are asked at check-in to complete them on a tablet in the waiting room to avoid encroaching on limited clinic time [45, 58]. This ensures that the clinician can access Skindex-16 scores in the electronic health record (EHR) while the patient is in the room. For patients with inflammatory or chronic skin conditions, PROM intervals should coincide with when the clinician wants to assess treatment response and monitor for adverse events. We are gathering real-world examples of how PROM scores have changed clinical care in dermatology, such as identifying unspoken melanoma concerns and non-obvious difficulties patients have with their skin—these are noted on the Dermatology PRO Consortium website [59].

A final consideration in PROM selection is cost—not all PROMs are free to access. We have included relevant licensing requirements and associated costs in Tables 1, 2 and 3, but these are not exhaustive and can change. A current list is maintained online by the Dermatology PRO Consortium [60]. For a more thorough treatise on how to select and implement PROMs in clinical practice, the International Society for Quality of Life Research (ISOQOL) produced a user’s guide [61]. Additionally, the international COSMIN initiative hosts free tools to help clinicians determine which measures are most appropriate for their goals [62].

7 Administering PROM(s) in Your Clinical Practice

Used regularly, PROMs can track patients’ symptom improvements (or lack thereof) with treatment. Paper-and-pencil has the advantage of tailoring PROMs to individual patients but requires staff or clinicians to manually calculate scores and enter them into the EHR. Electronic PROMs can be captured using a Health Insurance Portability and Accountability Act (HIPAA)-compliant app or software, and scores can be calculated automatically. When PROM data are collected in a Fast Healthcare Interoperability Resources (FHIR)-compatible manner, the data can link directly to a patient’s EHR. Paper and electronic PROMs are equivalent in responses and scores [63]. Electronic options may be useful in the growing field of teledermatology, where skin diseases can be tracked remotely with PROMs to offer cost-effective and reliable dermatologic care [64,65,66].

8 Potential Barriers to Routine PROM Use in Clinical Practice in Dermatology

Despite their benefits, to our knowledge, few US clinics have broadly implemented PROMs, for various reasons including perceived lack of relevance, lack of time in clinic, lack of reimbursement in the fee-for-service pay model, and lack of a universal EHR, among others [67,68,69]. Conversely, England’s National Health System has collected PROMs nationwide since 2009 [70].

At UUH Dermatology, PROM data has been used since 2017 to help track changes in dermatology patient symptoms and HRQL, enhance clinician–patient communication by providing insight into motivators for the patient visit, evaluate treatment effectiveness, and tailor treatment decisions [58, 71]. Based on change management principles [72], to successfully implement PROMs, one needs to identify early adopters, communicate the vision with the team, empower others, create short-term wins, and consolidate improvements.

By focusing early efforts with a few clinicians, one can work out institutional kinks and capture early successes. For example, we started using DLQI because it is commonly used in trials, but our dermatologists struggled with the non-intuitive scoring system. We switched to Skindex-16 and clinical PROM use increased immediately because clinicians intuitively understood a 0–100 scale. Also, we celebrated early successes in faculty meetings and grand rounds, identifying patient experiences where PROMs changed care or assisted with billing documentation requirements or prior authorization for an expensive medication [73].

Without additional research to support such efforts, changes in PROM scores should not be used as a surrogate for care quality [67, 68]. PROMs can function complementarily to clinician-reported outcome measures [74]. For example, a randomized trial showed that HRQL improvements, as measured with both Skindex-16 and DLQI, were similar for psoriasis patients followed via either teledermatology (online) or in person [75]. With the increased uptake of teledermatology due to COVID-19 [76, 77], PROMs offer value by remotely identifying acute flares in chronic skin issues, like autoimmune bullous diseases [78], which can trigger an urgent follow-up appointment.

Despite its challenges, developing a nationwide PROM program in the US is still possible but will need to start at the grass-roots level with like-minded dermatologists sharing insights and working together. Expert consensus groups will need to identify and prioritize optimal PROMs for specific populations of interest before implementing PROMs in a value-based model [69]. The AAD’s DataDerm would provide a great platform to rapidly collect and test the clinical value of specific PROMs on a national scale [57].

9 Conclusions

PROMs offer a quantifiable, reproducible way to measure disease-related concerns such as symptom severity and the impact of skin disease on HRQL and help individualize treatment decisions, monitor treatment success, and set realistic treatment expectations [71]. This overview can assist dermatologists in selecting appropriate PROMs for use in their routine clinical practice. Barriers still exist to routine PROM use in clinical care, but increasing technological advances and broader acceptance by patients of technology’s role in healthcare delivery are overcoming some of these barriers. Capturing similar PROM data across a wide range of clinical practices in the US and worldwide can help dermatologists, policymakers, and payors better appreciate the wide-ranging impact of skin diseases on our patients [20].