Predictors for Clinical Outcomes Related to Upper Extremity Musculoskeletal Disorders in a Healthy Working Population.

A wide range of endpoints and methods of analysis can be observed in occupational health studies in the context of work-related musculoskeletal disorders (WMSDs). Comparison of study results is therefore difficult. We investigated the association between different clinical endpoints and the presence of upper extremity WMSDs in a healthy working population. Furthermore, the influence of socio-demographic, work-related, and individual predictors on different endpoints was examined. Two self-administered questionnaires were distributed to 70 workers and employees. In addition, a standardized physical examination and an industry test were performed in this cross-sectional study. Correlations between WMSDs and clinical endpoints were analyzed with the Spearman method and prediction ellipses. Multiple regression models were used to study the strength of associations with a pre-defined set of potential influencing factors. The prevalence of WMSDs was 56% (39/70). Disabilities of Arm, Shoulder, and Hand (DASH) score/pain under strain showed the strongest correlations with WMSDs. When analyzing the correlation between WMSDs and pre-selected predictors, none of the predictors could be identified as a risk factor. The DASH score remains a close candidate for best surrogate endpoint for WMSDs detection. Standardized analysis methods could improve the methodological quality of future occupational health studies.

Endpoint selection for noninferiority percutaneous coronary intervention trials: a methodological description.

BACKGROUND: The objective of this review is to provide a practical update on endpoint selection for noninferiority (NI) studies in percutaneous coronary intervention studies. METHODS: A PubMed search was conducted for predefined terms to explore the use of NI designs and intrapatient comparisons to determine their current importance. Sample size calculations for the most frequently used endpoints with NI hypotheses were done to increase statistical awareness. RESULTS: Reported NI trials, with the most frequently chosen clinical endpoint of major adverse cardiac events (MACE), had NI margins ranging from 1.66% to 5.00%, resulting in patient populations of 400-1500 per treatment group. Clinical study endpoints comprising of MACE complemented with rates of bleeding complications and stent thrombosis (ST) are suggested to conduct a statistically and clinically meaningful NI trial. Study designs with surrogate endpoints amenable to intrapatient randomizations, are a very attractive option to reduce the number of necessary patients by about half. Comparative clinical endpoint studies with MACE and ST/bleeding rates to study a shortened dual antiplatelet therapy (DAPT) in coronary stent trials are feasible, whereas ST as the sole primary endpoint is not useful. CONCLUSIONS: Expanded composite clinical endpoints (MACE complemented by ST and bleeding rates and intrapatient randomization for selected surrogate endpoints) may be suitable tools to meet future needs in device approval, recertification and reimbursement.

Is Repetitive Workload a Risk Factor for Upper Extremity Musculoskeletal Disorders in Surgical Device Mechanics? A Cross-Sectional Analysis.

To assess the prevalence of upper extremity work-related musculoskeletal disorders (WMSDs) among surgical device mechanics compared to a control group, a total of 70 employees were included and assigned to three occupational groups (grinders, packers, and control). Personal factors, work exposure, manual skill, and complaints were assessed by two self-administered questionnaires and an industry test. WMSDs were diagnosed in a standardised clinical examination. The two-one-sided t-tests (TOST) procedure was used to test the clinical equivalence of the respective grinding and packaging groups vs. the control group in terms of the Disabilities of the Arm, Shoulder and Hand (DASH) score. Thirty-nine study participants (56%) experienced at least one WMSD at the elbow, forearm, and/or wrist, mainly with signs of epicondylitis and nerve entrapment at the medial elbow. The risk of grinders developing upper extremity WMSD was about 2.5-times higher and packers had an 8.6-fold higher risk of a clinically relevant DASH > 29 compared to the control group. However, these differences were not statistically significant. The groups were also proven to be clinically equivalent in terms of DASH score. Surgical device mechanics do not seem to have worse DASH values or be at higher risk of upper limb WMSDs compared to a control group. This is the first study to analyse and compare different workplaces in this industry that are also common in other industries.

Pelvic Tilt Angle Differences Between Symptom-Free Young Subjects and Elderly Patients Scheduled for THA: The Rationale for Tilt-Adjusted Acetabular Cup Implantation.

BACKGROUND: The question whether Pelvic Tilt (PT) angles measured in the supine position are adequate for the alignment of the acetabular cup without an adjustment for anatomical differences between patients is of clinical importance. The aim of this work was to test for factors that can significantly affect PT angles. METHODS: In the present retrospective cohort comparison, the PT angles of 12 Symptom-Free Young Subjects (SFYS) and 45 patients scheduled for Total Hip Arthroplasty (THA) were compared. The data was collected during two studies with the use of a novel smartphone-based navigated ultrasound measurement system. Multi-factorial analysis of variance was run to determine which factors significantly affect PT. RESULTS: Body position (F= 126.65; P< 0.001) and group (SFYS vs. THA patients) (F= 17.52; P< 0.001) had significant main effects on PT. There was also a significant interaction between body position and group (F= 25.59; P< 0.001). The mean PT increased by 8.1° from an interiorly to a neutral tilted position (P< 0.001) and 21.4° from a neutral to a posteriorly tilted position (P< 0.001) with the transition from the supine into the upright position for the SFYS and THA patients, respectively. CONCLUSION: In both groups, PT changed significantly with a transition from the supine to the upright position. A position-dependent mean PT increase in the patient group showed that acetabular cup alignment based on PT in the supine position is not reliable without taking into consideration the inclination of the pelvis in standing position. This may lead to instability and dislocations.

Intra- and Inter-rater Reliability of Navigated Ultrasound in the Assessment of Pelvic Tilt in Symptom-Free Young Adults.

OBJECTIVES: Pelvic tilt is the angle between the anterior pelvic plane and the coronal plane. It affects cup positioning in total hip arthroplasty. The primary objective of this study was to test the intra- and inter-rater reliability of a navigated smart device-based ultrasound system for pelvic tilt assessment. The secondary objective was to test the inter-rater variability of the measurements on a hip phantom. METHODS: A repeated-measures design was used. Two raters measured the pelvic tilt of 12 symptom-free young adults in upright and supine positions. Additionally, pelvic tilt was measured on a hip phantom. Each rater performed 3 measurements in each body position on the participants and 12 measurements on the hip phantom. Intra- and inter-rater reliability were calculated with the use of intraclass correlation coefficients. The variability in measurements on the hip phantom was assessed by a Bland-Altman analysis of agreement. RESULTS: Intraclass correlation coefficient 95% confidence intervals for intra-rater reliability ranged from good to excellent and moderate to excellent for the supine and upright positions respectively. Intraclass correlation coefficient 95% confidence intervals for inter-rater reliability ranged from poor to excellent for both positions. Hip phantom measurements showed no significant average bias (P > .05) and no significant proportional bias (P > .05). The 95% inter-rater limits of agreement were ±1.3° and ±1.7° for the supine and upright positions, respectively. CONCLUSIONS: The intra-rater reliability values achieved were suitable. Intraclass correlation coefficient values for inter-rater reliability remained below an acceptable level. Possible reasons and overcoming strategies were presented. The 95% limits of agreement were good, at less than ±2°.