The perplexity of prescribing and switching of biologic drugs in rheumatoid arthritis: a UK regional audit of practice.

BACKGROUND: Biologic drugs are expensive treatments used in rheumatoid arthritis (RA). Switching among them is common practice in patients who have had an inadequate response or intolerable adverse events. The National Institute of Health and Clinical Excellence (NICE) UK, which aims to curtail postcode prescribing, has provided guidance on the sequential prescription of these drugs. This study sought to evaluate the extent to which rheumatology centres across the Midlands were complying with NICE guidance on the switching of biologic drugs in RA, as well as analyse the various prescribing patterns of these drugs. METHODS: Data was collected via a web-based tool on RA patients who had undergone at least one switch of a biologic drug during 2011. The standards specified in NICE technology appraisals (TA130, TA186, TA195, TA198, and TA225) were used to assess compliance with NICE guidance. Descriptive statistical analysis was performed. RESULTS: There were 335 biologic drug switches in 317 patients. The most common reason given for switching to a drug was NICE guidelines (242, 72.2%), followed by Physician's choice (122, 33.4%). Lack of effect was the most common reason for discontinuing a drug (224, 67%). For patients on Rituximab, Methotrexate was used in 133 switches (76.9% of the time). Overall NICE compliance for all units was 65% (range 50 to 100%), with anti-TNFα to anti-TNFα switches for inefficacy making up the majority of non-compliant switches. CONCLUSION: This study draws attention to the enigma and disparity of commissioning and prescribing of biologic drugs in RA. Currently the evidence would not support switching of a biologic drug for non-clinical purposes such as economic pressures. Flexibility in prescribing should be encouraged: biologic therapy should be individualised based on the mode of action and likely tolerability of these drugs. Further work should focus on the evidence for using particular sequences of biologic drugs.

Design and validation of 2 objective structured clinical examination stations to assess core undergraduate examination skills of the hand and knee.

OBJECTIVE: To evaluate the development, validity, and reliability of 2 undergraduate Objective Structured Clinical Examination (OSCE) stations for core hand and knee examination skills. METHODS: Two OSCE stations for hand and knee based on core skills were developed, and qualitatively assessed for face and content validity by an expert consensus panel. Construct validity was evaluated by comparing the performance of third- (n = 21) and fifth-year (n = 50) medical students with 6 specialist registrars (SpR) in rheumatology. Concurrent validity was evaluated by correlating the scores of the fifth-year students with their eventual final examination scores. The fifth-year data were used to calculate the interrater and intrarater reliabilities of 2 examiners. Intrarater reliability analyzed repeat scores using videotapes of the examinations. RESULTS: Both stations were deemed to fulfil face and content validity criteria by the expert consensus panel. There was no significant difference in the mean scores of the third- and fifth-years. There were significant differences in the mean scores between both student groups and the SpR in both stations consistent with a valid construct theory. The fifth-year hand OSCE results correlated moderately with other indices of clinical skills, but not knowledge, and satisfied concurrent validity. Inter- and intrarater reliability for both stations was high. CONCLUSION: These OSCE stations are valid and reliable tools for testing competency in core hand and knee examination skills. They can be used in educational research as outcome measures of specific teaching interventions and can also be used as an early feedback tool when teaching joint examination.

Evidence-based clinical guidelines: a new system to better determine true strength of recommendation.

RATIONALE, AIMS AND OBJECTIVES: Clinical practice guidelines often grade the 'strength' of their recommendations according to the robustness of the supporting research evidence. The existing methodology does not allow the strength of recommendation (SOR) to be upgraded for recommendations for which randomized controlled trials are impractical or unethical. The purpose of this study was to develop a new method of determining SOR, incorporating both research evidence and expert opinion. METHODS: A Delphi technique was employed to produce 10 recommendations for the role of exercise therapy in the management of osteoarthritis of the hip or knee. The SOR for each recommendation was determined by the traditional method, closely linked to the category of research evidence found on a systematic literature search, and on a visual analogue scale (VAS). Recommendations were grouped A-D according to the traditional SOR allocated and the mean VAS calculated. Difference across the groups was assessed by one-way ANOVA variance analysis. RESULTS: Mean VAS scores for the traditional SOR groups A-D and one proposition which was 'not recommended' showed significant linearity on one-way ANOVA. However, certain recommendations which, for practical reasons, could not assessed in randomized controlled trials and therefore could not be recommended strongly by the traditional methodology, were allocated a strong recommendation by VAS. CONCLUSIONS: This new system of grading strength of SOR is less constrained than the traditional methodology and offers the advantage of allowing SOR for procedures which cannot be assessed in RCTs for practical or ethical reasons to be upgraded according to expert opinion.