We thank Mr. Davis and Dr. Feldman for their insightful comments in response to our study. They addressed how the Hawthorne effect, which occurs when patients' behaviors change (such as improving adherence) after knowing they are being watched in ways that may improve outcomes, could be leveraged in clinical practice. In our cross-sectional study, patients were evaluated at a single time point under real world conditions (e.g. routine follow-up visit) and did not know that the effectiveness of their psoriasis treatment was going to be formally assessed until the day of their regularly scheduled clinic visit 1. Thus the Hawthorne effect could not have affected adherence and was unlikely to have impacted our estimates of physician reported outcomes but may have influenced patient reported outcomes.
The degree to which suboptimal adherence with systemic psoriasis treatments influences effectiveness remains largely unknown. Nevertheless, optimizing patient adherence remains an important treatment goal and thus dermatologists may consider attempts at replicating the Hawthorne Effect in their clinical practices. However, achieving the Hawthorne effect in clinical practice may not be feasible for many practitioners and patients. More frequent follow-up office visits may be impractical due to various factors including time and expense for the patient and scheduling difficulties for the physician. Promising novel approaches to mimicking the type of close follow-up which occurs in the clinical trial setting include mobile tele-dermatology for home monitoring of psoriasis patients, which has been shown to have high acceptance ratings in both patients and dermatologists, with great potential for increasing patient motivation and compliance 2.
We also note that the factors which explain differences in efficacy observed in clinical trials and effectiveness observed in real world settings are complex and multi-factorial. For example, patients on systemic psoriasis treatments often face issues of access (treatment expense, delays in obtaining insurance approvals to continue treatment or lack of insurance approval to increase the dose of treatment due to sub-optimal response, difficulty in traveling to offices that provide psoriasis treatment, etc.), tachyphylaxis, and often patients express safety concerns that result in treatment discontinuation 3. Additionally, prior treatment experience, which may inform response rates may not be reflected in clinical trials (i.e CHAMPION and ACCEPT trials included only TNF inhibitor naïve patients whereas nearly 30% of our patients had used a different TNF inhibitor prior to their current TNF treatment) 4, 5.
The determinants of psoriasis treatment effectiveness in real world settings remain an important scientific knowledge gap. Prospective effectiveness studies are urgently needed in order to optimize the quality of care for patients with psoriasis.
Acknowledgments
Funding/Support: This study was supported by grant RC1-AR058204 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (Dr Gelfand), National Psoriasis Foundation Fellowship Award (Takeshita) and by Training Grants T32 GM 075766-6 (Takeshita) and T32-AR07465 (Wang) from the National Institutes of Health.
Role of the Sponsors: The sponsors had no role in the design and conduct of the study; in the collection, analysis, and interpretation of the data; or in the preparation, review, or approval of the manuscript.
This is a commentary on article Davis SA, Feldman SR. Using Hawthorne effects to improve adherence in clinical practice: lessons from clinical trials. JAMA Dermatol. 2013 Apr;149(4):490-1.
Footnotes
Author Contributions: Dr. Gelfand had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: Gelfand, Krueger, and Callis Duffin. Acquisition of data: Gelfand, Krueger, Callis Duffin, and Van Voorhees. Analysis and interpretation of data: Gelfand. Drafting of the manuscript: Gelfand and Wang. Critical revision of the manuscript for important intellectual content: Gelfand, Robertson, Krueger, Duffin, Van Voorhees, Takeshita, and Wang. Statistical analysis: Gelfand and Wang. Obtained funding: Gelfand and Callis Duffin. Administrative, technical, or material support: Gelfand. Study supervision: Gelfand and Krueger.
Financial Disclosure: Dr Gelfand served as a consultant for Abbott Laboratories, Amgen Inc, Celgene Corp, Merck, Janssen Biologics (formerly Centocor), Novartis Corp, and Pfizer Inc, receiving honoraria; had grants or has pending grants from Abbott Laboratories, Amgen Inc, Genentech Inc, Novartis Corp, and Pfizer Inc; and received payment for continuing medical education work related to psoriasis. Dr Krueger served as a consultant for Abbott Laboratories, Amgen Inc, and Janssen Biologics; had grants or has pending grants from Abbott Laboratories and Amgen Inc; and received payment for lectures and travel-related expenses from Abbott Laboratories, Amgen Inc, and Janssen Biologics. Dr Callis Duffin was an investigator, consultant, and/or speaker for Abbott Laboratories, Amgen, ApoPharma, Celgene, Eli Lilly, Genzyme, Incyte, Janssen Biologics/Centocor, NovoNordisk, Pfizer, and Wyeth, receiving honoraria and/or salary; served on the advisory board of Amgen; and received residency/fellowship program funding from Abbott Laboratories and Amgen. Dr Van Voorhees served on advisory boards for Amgen Inc, Abbott Laboratories, Genentech Inc, Warner Chilcott, Leo, and Janssen Biologics; served as an investigator for Amgen Inc, Abbott, Genentech Inc, receiving grants; served as a speaker for Amgen and Abbott and Janssen, consultant for Amgen Inc.
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