Assessing health professionals

BACKGROUND: Good professional regulation depends on high quality procedures for assessing professional performance. Professional assessment can also have a powerful educational impact by providing transparent performance criteria and returning structured formative feedback. AIM: This paper sets out to define some of the fundamental principles of good assessment design. CONCLUSIONS: It is essential to clarify the purpose of the assessment in question because this drives every aspect of its design. The intended focus for the assessment should be defined as specifically as possible. The scope of situations over which the result is intended to generalize should be established. Blueprinting may help the test designer to select a representative sample of practice across all the relevant aspects of performance and may also be used to inform the selection of appropriate assessment methods. An appropriately designed pilot study enables the test designer to evaluate feasibility, acceptability, validity (with respect to the intended focus) and reliability (with respect to the intended scope of generalization).     

Induction of melanoma-associated antigen systemic immunity upon intratumoral delivery of interferon-gamma retroviral vector in melanoma patients

A total of 17 patients with metastatic melanoma were treated with intratumoral interferon-gamma (IFN-gamma) retroviral vector in a phase I clinical trial. A cycle of treatment consisted of five daily injections every 2 weeks. Patients were divided into two treatment arms that involved a single course (one cycle) of treatment (group I; n = 9) and multiple cycles (six cycles) of treatment (group II; n = 8). Patients received intratumoral injections of IFN-gamma (10(7) plaque-forming units/mL administered at 0.3, 0.5, and 1.0 mL per cohort of patients). All patients receiving multiple injections either maintained stable disease (n = 5) or achieved a partial or complete response (n = 3) of the injected lesion, whereas in patients receiving a single cycle of treatment, only one of nine patients had a response. Patients were assessed for immunoglobulin G antibody (Ab) responses to the melanoma-associated antigens (MAA) tyrosinase, gp100, TRP-2, and MAGE-A1 by affinity enzyme-linked immunosorbent assay. Anti-MAGE-A1 and tyrosinase Ab were significantly elevated from baseline (day 0) to week 16 during treatment (P = .005; P = .002, respectively) in patients who received multiple injections. Patients undergoing treatment who had a clinical response (stable disease or better) also had significantly more elevated Ab responses to a greater number of MAA (P = .0004). The induction of systemic Ab responses to multiple MAA also correlated with systemic clinical responses. These studies suggest that multiple anti-MAA Ab responses are associated with clinical responses to IFN-gamma retroviral treatment and may be used as surrogate response markers.