Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

https://www.bmj.com/content/bmj/340/bmj.c869.full.pdf

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

Overwhelming evidence now indicates that the quality of reporting of randomized, controlled trials (RCTs) is less than optimal. Recent methodologic analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which boast the elimination of systematic error as their primary hallmark. Systematic error in RCTs reflects poor science, and poor science threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have adopted the CONSORT statement. The CONSORT statement facilitates critical appraisal and interpretation of RCTs by providing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, understanding, and dissemination of the CONSORT statement. The meaning and rationale for each checklist item are presented. For most items, at least one published example of good reporting and, where possible, references to relevant empirical studies are provided. Several examples of flow diagrams are included. The CONSORT statement, this explanatory and elaboration document, and the associated Web site (http://www.consort -statement.org) should be helpful resources to improve reporting of randomized trials.

/pdf/the-revised-consort-statement-for-reporting-randomized-5bhphpspur.pdf

The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration

Once a rarely used subset of medical treatments, protein therapeutics have increased dramatically in number and frequency of use since the introduction of the first recombinant protein therapeutic--human insulin--25 years ago. Protein therapeutics already have a significant role in almost every field of medicine, but this role is still only in its infancy. This article overviews some of the key characteristics of protein therapeutics, summarizes the more than 130 protein therapeutics used currently and suggests a new classification of these proteins according to their pharmacological action.

Protein therapeutics: a summary and pharmacological classification

Tumour necrosis factor (TNF) is a major inflammatory cytokine that was first identified for its ability to induce rapid haemorrhagic necrosis of experimental cancers. When efforts to harness this anti-tumour activity in cancer treatments were underway, a paradoxical tumour-promoting role of TNF became apparent. Now that links between inflammation and cancer are appreciated, is TNF a target or a therapeutic in malignant disease -- or both?

Tumour necrosis factor and cancer

Psoriatic arthritis (PsA) has been defined as a unique inflammatory arthritis associated with psoriasis. Its exact prevalence is unknown, but estimates vary from 0.3% to 1% of the population. The clinical features described initially are recognised by most experienced clinicians, although they are most distinct in early disease. Initially, PsA typically presents as an oligoarticular and mild disease. However, with time PsA becomes polyarticular, and it is a severe disease in at least 20% of patients. Patients with PsA who present with polyarticular disease are at risk for disease progression. In addition to progression of clinical and radiological damage, health related quality of life is reduced among patients with PsA. It important to note that patients included in recent drug trials resemble patients followed prospectively in a clinic.

https://ard.bmj.com/content/annrheumdis/64/suppl_2/ii14.full.pdf

Psoriatic arthritis: epidemiology, clinical features, course, and outcome

https://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(00)02530-7.pdf

Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial

The urethral catheter and urinary tract infection.

Psoriatic arthritis is a chronic, heterogeneous disease whose pathogenesis is unknown, although genetic, environmental, and immunologic factors play major roles. Psoriatic arthritis can follow an aggressive clinical course, and differentiating it from other arthropathies is sometimes difficult. Diagnosis of psoriatic arthritis is based on history, physical examination, the usual absence of rheumatoid factor, and characteristic radiographic features. At least 40% of patients with psoriatic arthritis develop radiographically detectable joint destruction; therefore, proper diagnosis and early treatment can have a significant impact on disease course and outcome. Understanding the pathogenesis of psoriatic disease has led to the use of several biologic agents that work by modulating T-cell signaling or by inhibiting key cytokines involved in inflammation, such as tumor necrosis factor (TNF). TNF inhibitors have demonstrated excellent efficacy in resolving skin and joint disease in patients with psoriatic arthritis and have been shown to be safe agents in various inflammatory disorders. This article reviews the diagnostic and treatment challenges of psoriatic arthritis as they relate to pathogenesis and burden of disease. Learning objective At the conclusion of this learning activity, participants should have acquired a more comprehensive knowledge of our current understanding of the classification, clinical presentation, etiology, pathophysiology, differential diagnosis, and treatment of psoriatic arthritis.

https://www.jaad.org/article/S0190-9622(04)01607-X/pdf

Diagnosis and treatment of psoriatic arthritis

Background Psoriasis is a debilitating chronic inflammatory autoimmune disease affecting approximately 7.4 million adults in the United States. Plaque psoriasis is the most common form, affecting 80% to 90% of patients. Objectives To describe the impact and challenges that psoriasis presents for various stakeholders, and to provide nondermatologist healthcare decision makers with information to enhance their contributions to drug and pharmacy benefit design discussions. Discussion Psoriasis carries an increased risk for early mortality and an increased prevalence of comorbidities, including psoriatic arthritis, cardiovascular disease, and diabetes. It is also associated with anxiety, depression, and social isolation, and can negatively impact patients' relationships, productivity, and careers. The physical, psychologic, social, and economic impact of psoriasis, plus the associated stigma, result in cumulative impairment over a patient's lifetime. The current treatments for moderate-to-severe psoriasis include topical therapy, phototherapy, and systemic drugs (nonbiologic and biologic); however, patient satisfaction remains low, combination therapy and treatment switching are common, and many patients remain untreated or undertreated. Clinicians should consider the patient holistically, and should select treatment based on a range of factors, including disease severity (with physical and psychosocial manifestations), susceptibility to cumulative life-course impairment (considering personality, behavior, and cognition), comorbidities, concomitant medication, and patient preference. It is estimated that the total annual direct cost of treating psoriasis in the United States in 2015 exceeded $12.2 billion. Conclusion Psoriasis is a complex disease, and appropriate management is correspondingly complex. Newer psoriasis treatments provide improved efficacy and safety versus traditional treatments, but challenges remain in ensuring patients access to these medications. An improved understanding of the barriers to appropriate treatment is needed, as well as clear and accessible information for payers and clinicians on current treatment options, to ensure that decision makers can control costs while providing patients with optimal care.

The Challenge of Managing Psoriasis: Unmet Medical Needs and Stakeholder Perspectives

Background: Palmoplantar pustular psoriasis (PPP) is difficult to treat. We assessed the effectiveness of alefacept in PPP and the safety of a 30 mg/week dose. Methods: Fifteen individuals with PPP were started on 15 mg/week intramuscularly (IM) alefacept. Efficacy was measured by the PPP severity instrument (PSI). Treatment was continued for 16 weeks, and the alefacept dose was increased to 30 mg/week IM at week 9 if the PSI did not decrease by at least 25%. Other outcomes included physician's global assessment (PGA), reported adverse events and CD4+ T‐lymphocyte counts. Clinical response was observed for 12 weeks after the last injection. Results: The severity of PPP improved in both the PSI and the PGA (p 250 cells/mm3. There were no severe adverse effects or discontinuations due to adverse events. Conclusions: Alefacept in...

Bernard S Goffe

Papers

Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial

The urethral catheter and urinary tract infection.

Diagnosis and treatment of psoriatic arthritis

The Challenge of Managing Psoriasis: Unmet Medical Needs and Stakeholder Perspectives

Open label trial of alefacept in palmoplantar pustular psoriasis