Study Goals, Hypothesis, and Design




(1)
Department of Health Management, New York Medical College, Valhalla, New York, USA

(2)
University of British Columbia, Vancouver, British Columbia, Canada

(3)
Misdiagnosis Association, Seattle, Washington, USA

 



Keywords
Psoralen and ultraviolet A (PUVA)InterferonIFNMycosis fungoidesStudy goalsHypothesisStudy designStudy method


The main purpose of the study presented herein (previously unpublished) was to determine and compare the efficacy of two treatment methods—one being psoralen and ultraviolet A (PUVA) monotherapy and the other being PUVA combined with interferon-alpha-2a in Mycosis Fungoides (MF) patients referred to the Razi Dermatology Hospital in Tehran, Iran. Our efforts focused on the comparison of these two treatment regimens with respect to complete remission, partial remission, different phases of MF, and effect of gender.


Study Goals


The main goal of our study was to investigate the efficacy of two MF treatment methods: PUVA monotherapy and PUVA with alpha interferon (IFN) .


Alternative Goals






  • Comparison of PUVA monotherapy and PUVA + IFN resulting in complete remission


  • Comparison of PUVA monotherapy and PUVA + IFN resulting in partial remission


  • Comparison of PUVA monotherapy and PUVA + IFN resulting in an overall response


  • Comparison of PUVA monotherapy and PUVA + IFN results as a function of patient’s age of diagnosis


  • Comparison of PUVA monotherapy and PUVA + IFN results as a function of patient gender


Application Goals


Although MF does not have curative treatment, skin-directed therapies, immunotherapies, and systemic chemotherapies could be applied to induce remission in MF. In our study, two treatment methods that are known to result in complete or partial remission were compared in terms of their efficacy as a long-term treatment option.


Hypotheses to Be Considered





  1. 1.


    The main question is to determine and compare the efficacy of several treatment options

     

  2. 2.


    Application of cytotoxic methods, by suppression of immune system, could affect treatment results

     

  3. 3.


    It seems that combination of two treatment methods, PUVA in the form of skin-directed therapy and alpha interferon (systematic immune system boost), can increase the chances of complete remissions

     

  4. 4.


    Combined treatment methods could result in a truly effective treatment for MF, which could be done through apoptosis of cancer cells, which also boosts the immune system

     


Design and Method



Study Design


The study is presented as a retrospective study and it included 50 patients diagnosed with MF by the means of biopsy, who were treated with either PUVA monotherapy or PUVA combined with interferon-alpha-2a (IFN-α[alpha]) at the Razi Dermatology Hospital during the years of September 2005 to August 2015. The type and level of skin lesions and presence of lymph node, visceral, or blood involvement according to the Bunn & Lamberg system and then the TNM (tumor, node, metastasis) system were used to determine the stage of MF [1].

Patient information such as age, sex, biopsy diagnosis, stage of MF, location and extent of cutaneous involvement, and type and severity of noncutaneous involvement were collected (Table 10.1). Data collected regarding PUVA monotherapy and PUVA plus IFN-α(alpha) treatment regimens included number of treatments, response to treatment, and adverse effects. After the application of the first treatment, the patients would come in every 2–3 weeks to be reviewed and application of another round of their specified treatment. All patients were followed for a period of 24 months. Furthermore, the treatment responses were then used for comparison, starting with the initial course of treatment (see next chapter).
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Dec 3, 2017 | Posted by in Dermatology | Comments Off on Study Goals, Hypothesis, and Design

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