EULAR points to consider for therapeutic drug monitoring of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases.

OBJECTIVE: To develop EULAR points-to-consider for therapeutic drug monitoring (TDM) of biopharmaceuticals in inflammatory rheumatic and musculoskeletal diseases (RMDs). METHODS: The points-to-consider were developed in accordance with EULAR standardised operation procedures by a multidisciplinary task force from eight European countries, based on a systematic literature review and expert consensus. Level of evidence and strength of the points-to-consider were determined, and mean levels of agreement among the task force were calculated using a 10-point rating scale. RESULTS: Six overarching principles and 13 points-to-consider were formulated. The level of agreement among the task force for the overarching principles and points-to-consider ranged from 8.4 to 9.9.The overarching principles define TDM and its subtypes, and reinforce the underlying pharmacokinetic/pharmacodynamic principles, which are relevant to all biopharmaceutical classes. The points-to-consider highlight the clinical utility of the measurement and interpretation of biopharmaceutical blood concentrations and antidrug antibodies in specific clinical scenarios, including factors that influence these parameters. In general, proactive use of TDM is not recommended but reactive TDM could be considered in certain clinical situations. An important factor limiting wider adoption of TDM is the lack of both high quality trials addressing effectiveness and safety of TDM and robust economic evaluation in patients with RMDs. Future research should focus on providing this evidence, as well as on further understanding of pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals. CONCLUSION: These points-to-consider are evidence-based and consensus-based statements for the use of TDM of biopharmaceuticals in inflammatory RMDs, addressing the clinical utility of TDM.

Can training in musculoskeletal examination skills be effectively delivered by undergraduate students as part of the standard curriculum?

OBJECTIVES: There is a need to improve competence of musculoskeletal system (MSS) examination in medical students and junior doctors. Peer-assisted learning (PAL) is a technique whereby students learn from and with each other. This study aimed to determine whether PAL can be integrated into standard undergraduate medical curricula to improve MSS examination using the gait, arms, legs, spine (GALS) screening tool. METHODS: Fifty final-year students (trainers) were trained using GALS for MSS examination while attending a standard clinical medical attachment at Glasgow Royal Infirmary. These students delivered GALS training to a further 159 students (trainees). Pre/post-confidence questionnaire (100-mm visual analogue scale) and written feedback were obtained. Final Objective Structured Clinical Examination (OSCE) scores from an MSS station were compared with a control group of 229 students randomized to other hospitals for the standard MSS training. RESULTS: Analysis of completed trainer questionnaires (30/50) showed increased confidence in all parts of GALS after training [<47 (19) cf. >88 (12); P < 0.005]. Similarly, confidence in trainees (136/159) who answered the questionnaire increased [<43 (19) cf. >85 (15); P < 0.005]. Written comments highlighted that students would recommend PAL. OSCE results showed 84% (192/229) of students in the control group passed the MSS station, with 87% (139/159) of trainees (P = 0.3) and 100% (50/50) of trainers (P < 0.01). CONCLUSIONS: MSS examination skills are improved by integrating PAL into the undergraduate medical curriculum, with student confidence being increased, and higher OSCE scores.