Search

Pelvic and acetabular fractures are challenging injuries to treat. This review evaluates three-dimensional intraoperative imaging and navigation-guided percutaneous SI, trans-iliac, trans-sacral, and acetabular screw placement versus conventional methods performed with C-arm imaging. A systematic search of MEDLINE, Embase, and Cochrane was performed. Two reviewers independently extracted data into a collaborative data form designed a priori and piloted prior to its use. Descriptive statistics are presented where applicable. Summary statistics analysis was presented based on the fracture type. Continuous data such as fluoroscopic and operative time were compared with unpaired Student t -test and pooled data of revision rate and complications were compared with chi-square analysis with an alpha set at 0.05. The rate of complications using conventional fluoroscopy was 11.3% (26/230) compared to three-dimensional navigation (6.7% (40/597), X 2 (DF: 1, N = 827) = 4.79, p = .028.) which translated to a higher rate of revision surgeries in the conventional fluoroscopy group (10.9% vs. 0.8%) X 2 (DF: 1, N = 827) = 47.8, p ≤.001. Average fluoroscopic time was lower for studies using three-dimensional navigation (28.8 ± 14.3 s, n = 71) compared to conventional fluoroscopy (57.8 ± 4.2 s, n = 38, p ≤.001). Three-dimensional navigation during minimally invasive pelvis and acetabular fracture fixation may have some benefits. Level of evidence: IV.

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Introduction: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. Methods: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. Results: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p

Abstract Background Joint replacement provides significant improvements in pain, physical function, and quality of life in patients with osteoarthritis. With a growing body of evidence indicating that frailty can be treated, it is important to determine whether targeting frailty reduction in hip and knee replacement patients improves post-operative outcomes. Objectives The primary objective is to examine the feasibility of a parallel group RCT comparing a preoperative multi-modal frailty intervention to usual care in pre-frail/frail older adults undergoing elective unilateral hip or knee replacements. The secondary objectives are1.To explore potential efficacy of the multi-modal frailty intervention in improving frailty and mobility between baseline and 6 weeks post-surgery using Fried frailty phenotype and short performance physical battery (SPPB) respectively.2.To explore potential efficacy of the multi-modal frailty intervention on post-operative healthcare services use. Methods/Design In a parallel group pilot RCT, participants will be recruited from the Regional Joint Assessment Program in Hamilton, Canada. Participants who are (1) ≥ 60 years old; (2) pre-frail (score of 1 or 2) or frail (score of 3–5; Fried frailty phenotype); (3) having elective unilateral hip or knee replacement; and (4) having surgery wait times between 3 and 10 months will be recruited and randomized to either the intervention or usual care group. The multi-modal frailty intervention components will include (1) tailored exercise program (center-based and/or home-based) with education and cognitive behavioral change strategies; (2) protein supplementation; (3) vitamin D supplementation; and (4) medication review. The main comparative analysis will take place at 6 weeks post-operative. The outcome assessors, data entry personnel, and data analysts are blinded to treatment allocation. Assessments: feasibility will be assessed by recruitment rate, retention rate, and data collection completion. Frailty and healthcare use and other clinical outcomes will be assessed. The study outcomes will be collected at the baseline, 1 week pre-operative, and 6 weeks and 6 months post-operative. Discussion This is the first study to examine the feasibility of multi-modal frailty intervention in pre-frail/frail older adults undergoing hip or knee replacement. This study will inform the planning and designing of multi-modal frailty interventional studies in hip and knee replacement patients. Trial registration ClinicalTrials.gov NCT02885337

This is a technique guide for open anterior capsule reconstruction in unstable native hips due to Ehlers–Danlos syndrome. Ehlers–Danlos syndrome is a connective tissue disease that predisposes an individual to hypermobility of their soft tissues and recurrent subluxations and dislocations of their joints. This may lead to constant instability, guarding of the hip, and subsequent arthritic changes and poor quality of life. We demonstrate anterior capsule reconstruction of the hip using an Achilles tendon allograft performed through a direct anterior approach to the hip (Heuter's approach). This technique guide outlines in detail the surgical steps required to accomplish this reconstructive procedure. Furthermore, a narrated surgical video is provided that clearly depicts the anticipated result of the increased constrained provided to the hip from the anterior capsule reconstruction using an Achilles tendon allograft.

Genome-wide association studies have identified numerous genetic loci for spirometic measures of pulmonary function, forced expiratory volume in one second (FEV(1)), and its ratio to forced vital capacity (FEV(1)/FVC). Given that cigarette smoking adversely affects pulmonary function, we conducted genome-wide joint meta-analyses (JMA) of single nucleotide polymorphism (SNP) and SNP-by-smoking (ever-smoking or pack-years) associations on FEV(1) and FEV(1)/FVC across 19 studies (total N = 50,047). We identified three novel loci not previously associated with pulmonary function. SNPs in or near DNER (smallest P(JMA = )5.00×10(-11)), HLA-DQB1 and HLA-DQA2 (smallest P(JMA = )4.35×10(-9)), and KCNJ2 and SOX9 (smallest P(JMA = )1.28×10(-8)) were associated with FEV(1)/FVC or FEV(1) in meta-analysis models including SNP main effects, smoking main effects, and SNP-by-smoking (ever-smoking or pack-years) interaction. The HLA region has been widely implicated for autoimmune and lung phenotypes, unlike the other novel loci, which have not been widely implicated. We evaluated DNER, KCNJ2, and SOX9 and found them to be expressed in human lung tissue. DNER and SOX9 further showed evidence of differential expression in human airway epithelium in smokers compared to non-smokers. Our findings demonstrated that joint testing of SNP and SNP-by-environment interaction identified novel loci associated with complex traits that are missed when considering only the genetic main effects.

Background. The Dental Practice-Based Research Network (DPBRN) provided a means to investigate whether certain procedures were performed routinely. The authors conducted a study to quantify rubber dam use during root canal treatment (RCT) among general dentists and to test the hypothesis that certain dentist or practice characteristics were associated with rubber dam use. Methods. DPBRN practitioner-investigators (P-Is) answered a questionnaire that included items about rubber dam use and other forms of isolation during RCT. DPBRN enrollment questionnaire data provided information regarding practitioner and practice characteristics. Results. A total of 729 (74 percent) of 991 P-Is responded; 524 were general dentists who reported providing at least some RCTs and reported the percentage of RCTs for which they used a rubber dam. Of these 524 P-Is, 44 percent used a rubber dam for all RCTs, 24 percent used it for 51 to 99 percent of RCTs, 17 percent used it for 1 to 50 percent of RCTs, and 15 percent never used it during RCT. Usage varied significantly by geographic region and practice type. The use of cotton rolls and other forms of isolation also was reported. Conclusions. Similar to other reports in the literature, not all DPBRN general dentists used a rubber dam during RCT. Clinical Implications. Because the clinical reference standard is to use a rubber dam during RCT, increasing its use may be important. [ABSTRACT FROM AUTHOR]

Background The statistical power of cluster randomized trials depends on two sample size components, the number of clusters per group and the numbers of individuals within clusters (cluster size). Variable cluster sizes are common and this variation alone may have significant impact on study power. Previous approaches have taken this into account by either adjusting total sample size using a designated design effect or adjusting the number of clusters according to an assessment of the relative efficiency of unequal versus equal cluster sizes.Purpose This article defines a relative efficiency of unequal versus equal cluster sizes using noncentrality parameters, investigates properties of this measure, and proposes an approach for adjusting the required sample size accordingly.Methods We focus on comparing two groups with normally distributed outcomes using t-test, and use the noncentrality parameter to define the relative efficiency of unequal versus equal cluster sizes and show that statistical power depends only on this parameter for a given number of clusters. We calculate the sample size required for an unequal cluster sizes trial to have the same power as one with equal cluster sizes.Results Relative efficiency based on the noncentrality parameter is straightforward to calculate and easy to interpret. It connects the required mean cluster size directly to the required sample size with equal cluster sizes. Consequently, our approach first determines the sample size requirements with equal cluster sizes for a pre-specified study power and then calculates the required mean cluster size while keeping the number of clusters unchanged. Our approach allows adjustment in mean cluster size alone or simultaneous adjustment in mean cluster size and number of clusters, and is a flexible alternative to and a useful complement to existing methods. Comparison indicated that we have defined a relative efficiency that is greater than the relative efficiency in the literature under some conditions.Limitations Our measure of relative efficiency might be less than the measure in the literature under some conditions, underestimating the relative efficiency.Conclusions The relative efficiency of unequal versus equal cluster sizes defined using the noncentrality parameter suggests a sample size approach that is a flexible alternative and a useful complement to existing methods. Clinical Trials 2011; 8: 27—36. http://ctj.sagepub.com [ABSTRACT FROM PUBLISHER]

Background We hypothesized that fibrinogen, as a marker of chronic inflammation, is inversely associated with forced vital capacity (FVC) and forced expiratory volume in 1 s (FEV1) in healthy persons.Methods The CARDIA cohort started in 1985 and included black and white men and women, aged 18–30, from the general population. Spirometry testing conducted at years 5 and 10 [FVC, FEV1, and their ratio (FEV1/FVC)] was studied relative to plasma fibrinogen levels measured at year 5 (cross-sectional n = 4040) and at year 7 (longitudinal n = 3001), controlling for race, sex, age, height, smoking, asthma, body mass index, physical activity, birth control pill use, and alcohol intake.Results In cross-sectional analyses, FVC at year 5 was lower by 166 ml (95% confidence interval 116–216 ml) in the highest vs lowest year 5 fibrinogen quartile. At year 10, holding year 5 FVC and change in fibrinogen (year 7–year 5) constant, the difference in FVC between the highest and the lowest year 5 fibrinogen quartiles widened by 67 ml (95% CI 31–103 ml). The corresponding differences for FEV1 were 166 ml (95% CI 146–253 ml) at year 5 and 45 ml (95% CI 11–80 ml) widening by year 10. The FEV1/FVC ratio was unrelated to plasma fibrinogen.Conclusion These findings are consistent with the hypothesis that fibrinogen, possibly as a marker for chronic low-grade inflammation, is associated with modest deterioration of lung function in healthy young adults. [ABSTRACT FROM AUTHOR]

Background The link between socioeconomic status (SES) and health is widely recognized but the pathophysiologic mechanisms are not well understood. We tested the hypothesis that parasympathetic nervous system (PNS) regulation is one such mechanism.Methods In a cross-sectional study, electrocardiogram-derived RR interval variability (RRV), a non-invasive index of cardiac PNS regulation, and SES, measured as educational attainment and income, were collected in 756 subjects in the CARDIA study of heart disease in young adults.Results Relative to those with less than a high school education, those with high school to college and post-college education had 26% (β = 0.233) and 43% (β = 0.355) greater low frequency (LF) RRV, respectively, adjusted for age, sex, and race. For high frequency (HF) RRV, race interacted with income: relative to low income whites, intermediate and high income whites had 133 and 191% greater HF power, respectively, while intermediate and high income blacks had 32 and 44% greater HF RRV, respectively, relative to low income blacks.Conclusions Numerous studies demonstrate that psychosocial stressors reduce cardiac parasympathetic regulation and that SES disparities are associated with increasing social stress proportional to the degree of disparity. Data from the current study suggest that PNS regulation may be a mechanism linking the stressful effects of low SES to increased morbidity and mortality. [ABSTRACT FROM AUTHOR]

BACKGROUND:Genome-wide association studies (GWAS) have identified numerous loci influencing cross-sectional lung function, but less is known about genes influencing longitudinal change in lung function. METHODS:We performed GWAS of the rate of change in forced expiratory volume in the first second (FEV1) in 14 longitudinal, population-based cohort studies comprising 27,249 adults of European ancestry using linear mixed effects model and combined cohort-specific results using fixed effect meta-analysis to identify novel genetic loci associated with longitudinal change in lung function. Gene expression analyses were subsequently performed for identified genetic loci. As a secondary aim, we estimated the mean rate of decline in FEV1 by smoking pattern, irrespective of genotypes, across these 14 studies using meta-analysis. RESULTS:The overall meta-analysis produced suggestive evidence for association at the novel IL16/STARD5/TMC3 locus on chromosome 15 (P = 5.71 × 10(-7)). In addition, meta-analysis using the five cohorts with ≥3 FEV1 measurements per participant identified the novel ME3 locus on chromosome 11 (P = 2.18 × 10(-8)) at genome-wide significance. Neither locus was associated with FEV1 decline in two additional cohort studies. We confirmed gene expression of IL16, STARD5, and ME3 in multiple lung tissues. Publicly available microarray data confirmed differential expression of all three genes in lung samples from COPD patients compared with controls. Irrespective of genotypes, the combined estimate for FEV1 decline was 26.9, 29.2 and 35.7 mL/year in never, former, and persistent smokers, respectively. CONCLUSIONS:In this large-scale GWAS, we identified two novel genetic loci in association with the rate of change in FEV1 that harbor candidate genes with biologically plausible functional links to lung function.