The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management.

OBJECTIVE: This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. METHODS: The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks. RESULTS: Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest-ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy. CONCLUSIONS: The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success.

The effects of different sensory augmentation on weight-shifting balance exercises in Parkinson's disease and healthy elderly people: a proof-of-concept study.

BACKGROUND: Earlier versions of biofeedback systems for balance-related applications were intended primarily to provide "alarm" signals about body tilt rather than to guide rehabilitation exercise motion. Additionally, there have been few attempts to evaluate guidance modalities for balance rehabilitation exercises. The purpose of this proof-of-concept study is to evaluate the effects of guidance modalities during common dynamic weight-shifting exercises used in clinical settings. METHODS: A motion guidance system providing visual biofeedback, vibrotactile biofeedback, or both, was used during weight-shifting exercises. Eleven people with idiopathic Parkinson's disease (PD) and nine healthy elderly people participated. Each participant wore a six-degree-of-freedom inertial measurement unit (IMU) located near the sacrum and four linear vibrating actuators (Tactors) attached to the skin over the front, back, and right and left sides of the abdomen. The IMU measured angular displacements and velocities of body tilt in anterior-posterior (A/P) and medial-lateral (M/L) directions. Participants were instructed to follow a slow moving target by shifting their weight in either the A/P or M/L direction up to 90 % of their limits of stability (LOS). Real-time position error was provided to participants in one of three sensory modalities: visual, vibrotactile, or both. Participants performed 5 trials for each biofeedback modality and movement direction (A/P and M/L) for a total of 30 trials in a random order. To characterize performance, position error was defined as the average absolute difference between the target and participant movements in degrees. RESULTS: Simultaneous delivery of visual and vibrotactile biofeedback resulted in significantly lower position error compared to either visual or vibrotactile biofeedback alone regardless of the movement direction for both participant cohorts. The pairwise comparisons were not significantly different between visual and vibrotactile biofeedback. CONCLUSION: The study is the first attempt to assess the effects of guidance modalities on common balance rehabilitation exercises in people with PD and healthy elderly people. The results suggest that combined visual and vibrotactile biofeedback can improve volitional responses during postural tracking tasks. Index Terms - sensory augmentation, weight-shifting balance exercise, guidance modality, vibrotactile biofeedback, visual biofeedback, Parkinson's disease.