Outcomes following operative and non-operative management of humeral midshaft fractures: a prospective, observational cohort study of 47 patients

Background Although the non-operative management of closed humeral midshaft fractures has been advocated for years, the increasing popularity of operative intervention has left the optimal treatment choice unclear. Objective To compare the outcomes of operative and non-operative treatment of traumatic closed humeral midshaft fractures in adult patients. Methods A multicentre prospective comparative cohort study across 20 centres was conducted. Patients with AO type 12 A2, A3 and B2 fractures were treated with a functional brace or a retrograde-inserted unreamed humeral nail. Follow-up measurements were taken at 6, 12 and 52 weeks after the injury. The primary outcome was fracture healing after 1 year. Secondary outcomes included sub-items of the Constant score, general patient satisfaction, complications and cost-effectiveness parameters. Functions of the uninjured extremity were used as reference parameters. Intention-to-treat analysis was applied with the use of t-tests, Fisher’s exact tests, Mann–Whitney U-tests and adjusted analysis of variance (ANOVA). Results Forty-seven patients were included. The patient sample consisted of 23 women and 24 men, with a mean age of 52.7 years (range 17–86 years). Of the 47 cases, 14 were treated non-operatively and 33 operatively. The follow-up rate at 1 year was 81%. After 1 year, 11 fractures (100%) healed in the non-operative group and at least 24 fractures (≥89%) healed in the operative group [1 non-union patient (4%) and no data for 2 patients (7%)]. There were no significant differences in pain, range of motion (ROM) of the shoulder and elbow, and return to work after 6 weeks, 12 weeks and 1 year. Although operatively treated patients showed significantly greater shoulder abduction strength (p = 0.036), elbow flexion strength (p = 0.021), functional hand positioning (p = 0.008) and return to recreational activities (p = 0.043) after 6 weeks, no statistically significant differences existed in any outcome measure at the 1-year follow-up. Conclusions Our findings indicate that the non-operative management of humeral midshaft fractures can be expected to have similar functional outcomes and patient satisfaction at 1 year, despite an early benefit to operative treatment. If no radiological evidence of fracture healing exists in non-operatively treated patients during early follow-up, a switch to surgical treatment results in good functional outcomes and patient satisfaction. Keywords: Humeral shaft fracture, Non-operative treatment, Functional brace, Operative treatment, Unreamed humeral nail (UHN), Prospective, Cohort study

A multilevel investigation of inequalities in clinical and psychosocial outcomes for women after breast cancer

Background In Australia, breast cancer is the most common cancer affecting Australian women. Inequalities in clinical and psychosocial outcomes have existed for some time, affecting particularly women from rural areas and from areas of disadvantage. We have a limited understanding of how individual and area-level factors are related to each other, and their associations with survival and other clinical and psychosocial outcomes. Methods/Design This study will examine associations between breast cancer recurrence, survival and psychosocial outcomes (e.g. distress, unmet supportive care needs, quality of life). The study will use an innovative multilevel approach using area-level factors simultaneously with detailed individual-level factors to assess the relative importance of remoteness, socioeconomic and demographic factors, diagnostic and treatment pathways and processes, and supportive care utilization to clinical and psychosocial outcomes. The study will use telephone and self-administered questionnaires to collect individual-level data from approximately 3, 300 women ascertained from the Queensland Cancer Registry diagnosed with invasive breast cancer residing in 478 Statistical Local Areas Queensland in 2011 and 2012. Area-level data will be sourced from the Australian Bureau of Statistics census data. Geo-coding and spatial technology will be used to calculate road travel distances from patients' residence to diagnostic and treatment centres. Data analysis will include a combination of standard empirical procedures and multilevel modelling. Discussion The study will address the critical question of: what are the individual- or area-level factors associated with inequalities in outcomes from breast cancer? The findings will provide health care providers and policy makers with targeted information to improve the management of women with breast cancer, and inform the development of strategies to improve psychosocial care for women with breast cancer.

Methodological challenges when estimating the effects of season and seasonal exposures on birth outcomes

Background Many previous studies have found seasonal patterns in birth outcomes, but with little agreement about which season poses the highest risk. Some of the heterogeneity between studies may be explained by a previously unknown bias. The bias occurs in retrospective cohorts which include all births occurring within a fixed start and end date, which means shorter pregnancies are missed at the start of the study, and longer pregnancies are missed at the end. Our objective was to show the potential size of this bias and how to avoid it. Methods To demonstrate the bias we simulated a retrospective birth cohort with no seasonal pattern in gestation and used a range of cohort end dates. As a real example, we used a cohort of 114,063 singleton births in Brisbane between 1 July 2005 and 30 June 2009 and examined the bias when estimating changes in gestation length associated with season (using month of conception) and a seasonal exposure (temperature). We used survival analyses with temperature as a time-dependent variable. Results We found strong artificial seasonal patterns in gestation length by month of conception, which depended on the end date of the study. The bias was avoided when the day and month of the start date was just before the day and month of the end date (regardless of year), so that the longer gestations at the start of the study were balanced by the shorter gestations at the end. After removing the fixed cohort bias there was a noticeable change in the effect of temperature on gestation length. The adjusted hazard ratios were flatter at the extremes of temperature but steeper between 15 and 25°C. Conclusions Studies using retrospective birth cohorts should account for the fixed cohort bias by removing selected births to get unbiased estimates of seasonal health effects.