Needle puncture injury causes acute and long‐term mechanical deficiency in a mouse model of intervertebral disc degeneration

Low back pain is a significant socioeconomic burden and intervertebral disc degeneration has been implicated as a cause. A reliable animal model of disc degeneration is necessary to evaluate therapeutics, and functional metrics are essential to quantify their benefit. To this end, needle puncture injuries were created in the caudal intervertebral discs of mice to induce disc degeneration. Compression, torsion, and creep mechanics were assessed both immediately and after eight weeks to distinguish between the effects of injury and the subsequent reparative or degenerative response. Two needle sizes (29 and 26 gauge) were used to determine injury size‐dependence. Compressive stiffness (62%), torsional stiffness (60%), and early damping stiffness (84%) decreased immediately after injury with the large needle (26G). These mechanical properties did not change over time despite structural and compositional changes. At 8 weeks following large needle injury, disc height decreased (37%), nucleus pulposus (NP) glycosaminoglycan content decreased (41%), and NP collagen content increased (45%). The small needle size had no significant effect on mechanics and did not initiate degenerative changes in structure and composition. Thus, the injection of therapeutics into the NP with a minimal needle size may limit damage due to the needle insertion. These findings, along with the wide commercial availability of mouse‐specific biological probes, indicate that the mouse caudal disc model can be a powerful tool for investigating disc degeneration and therapy. © 2013 Orthopaedic Research Society Published by Wiley Periodicals, Inc. J Orthop Res 31:1276–1282, 2013     

Spanish-language version of the MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS): preliminary validation

BACKGROUND AND PURPOSE: An instrument that provides valid measurements of satisfaction with physical therapy care for Spanish-speaking patients will enhance communication and ensure their representation in quality assurance analyses and research on health care disparities. The purpose of this investigation was to provide preliminary information on the factor structure, group- and individual-level reliability, and criterion-referenced validity of measurements obtained from a Spanish-language version of the MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care (MRPS). SUBJECTS: A total of 203 Spanish-speaking patients in the New York City area participated in this study. METHODS: Consenting subjects completed a 20-item MRPS after discharge from outpatient physical therapy care. Several translators performed "forward" and "backward" translation of the MRPS, followed by consensus agreement on item structure. Factor structure was investigated using item-correlation and exploratory factor analysis. Group-level reliability for single test administration was assessed using the Cronbach alpha, and individual-level reliability was assessed by calculating the standard error of the measure (SEM). Concurrent validity was tested by comparing the item scores and mean scores of factors to global measures of satisfaction. RESULTS: The means of individual item scores (1-5) ranged from 3.22 for "I did not wait too long" to 4.80 for "My therapist treated me respectfully." There were no sex-based differences in item scores. Exploratory factor analysis suggested a 2-factor solution: a 7-item "external" factor and a 3-item "internal" factor. The correlations (r) of the mean scores from these factors with the 2 global measures ranged from .59 to .82. The SEM was 0.16 for the internal factor and 0.25 for the external factor. DISCUSSION AND CONCLUSION: The underlying factor structure of the Spanish-language version of the MRPS was identical to the English-language version. Our findings provide preliminary support for the reliability and validity of measurements obtained from the Spanish-language version of the MRPS. Further study is needed to assess the stability of these findings in other samples. As with English-speaking patients, Spanish-speaking patient's satisfaction with physical therapy care is most strongly linked to the professional behavior of the clinician.     

Use of preoperative antidepressants is not associated with postoperative hospital length of stay

Purpose

Antidepressant medications are commonly prescribed for the treatment of depression, anxiety, and chronic pain. Their use may lead to a number of side effects with important implications in the perioperative period. Our aim was to examine the effect of preoperative antidepressant administration on post-surgical hospital length of stay (LOS) in elective non-cardiac surgery patients.

Design

Historical cohort study.

Methods

Demographic and preoperative data were collected by chart review for all non-cardiac surgery patients who were assessed in the preoperative consult clinic from April 2008 through February 2009. Patients were grouped according to whether or not they were taking antidepressant medications. Median length of stay was compared between patients who took antidepressants preoperatively and those who did not.

Results

Data were collected for 3,692 patients. Two hundred eighty-nine (7.8%) patients were taking antidepressants preoperatively. Use of antidepressants was not associated with an increased hospital LOS. The median LOS was four days both for patients who took antidepressants preoperatively (95% confidence interval [CI] 4 to 4) and for those who did not (95% CI 3 to 5) (P = 0.13).

Conclusions

The preoperative use of antidepressant medications was not associated with increased postoperative hospital LOS following elective non-cardiac surgery.     

A randomized feasibility trial of clonidine to reduce perioperative cardiac risk in patients on chronic beta-blockade: the EPIC study

Purpose

Clonidine may help prevent cardiac complications in patients undergoing non-cardiac surgery and receiving chronic beta-blocker therapy. We conducted a multicentre pilot randomized trial to estimate recruitment rates for a full-scale trial and to assess the safety and tolerability of combining clonidine with chronic beta-blockade.

Methods

Patients who were at elevated perioperative cardiac risk, receiving chronic beta-blockade, and scheduled for major non-cardiac surgery were recruited in a blinded (participants, clinicians, outcome assessors) placebo-controlled randomized trial at three Canadian hospitals. Participants were randomized to clonidine (0.2 mg oral tablet one hour before surgery, plus 0.2 mg·day^?1 transdermal patch placed one hour before surgery and removed four days after surgery or hospital discharge, whichever came first) or matching placebo. Feasibility was evaluated based on recruitment rates, with each centre being required to recruit 50 participants within 12-18 months. Additionally, we reviewed study drug withdrawals and safety outcomes, including clinically significant hypotension or bradycardia.

Results

Eighty-two of the 168 participants were randomized to receive clonidine and 86 to receive placebo. The average time to recruit 50 participants at each centre was 14.3 months. Six patients (7%) withdrew from clonidine, while four (5%) withdrew from placebo. Based on qualitative review, there were no major safety concerns related to clonidine. There was a moderate overall rate of cardiac morbidity, with 18 participants (11%) suffering postoperative myocardial infarction.

Conclusion

This pilot randomized trial confirmed the feasibility, safety, and tolerability of a full-scale trial of oral and transdermal clonidine for reducing the risk of cardiac complications during non-cardiac surgery. This trial was registered at www.clinicaltrials.gov: NCT00335582.     

In utero repair of myelomeningocele with autologous amniotic membrane in the fetal lamb model

Background

Despite advances in prenatal repair, myelomeningocele (MMC) still produces devastating neurologic deficits. The amniotic membranes (AM) are a biologically active tissue that has been used anecdotally for human fetal MMC repair. This study evaluated the use of autologous AM compared to skin closure in an established fetal MMC model.

Methods

Seven fetal lambs underwent surgical creation of MMC at gestational age of 75 days followed by in utero repair at gestational age of 100 days. Lambs were repaired with an autologous AM patch followed by skin closure (n = 4) or skin closure alone (n = 3). Gross necropsy and histopathology of the spinal cords were performed at term to assess neuronal preservation at the lesion.

Results

An increase in preserved motor neurons and a larger area of spinal cord tissue were seen in AM-repaired lambs, as was decreased wound healing of the overlying skin. Loss of nearly all spinal cord tissue with limited motor neuron preservation was seen in skin only-repaired lambs.

Conclusions

AM-repaired lambs showed increased protection of spinal cord tissue compared to skin only-repaired lambs, but the overlying skin failed to close in AM-repaired lambs. These results suggest a potential role for AM in fetal MMC repair that warrants further study.     

Community Mobilization and Empowerment of Female Sex Workers in Karnataka State,South India: Associations With HIV and Sexually Transmitted Infection Risk

Objectives. We examined the impact of community mobilization (CM) on the empowerment, risk behaviors, and prevalence of HIV and sexually transmitted infection in female sex workers (FSWs) in Karnataka, India.Methods. We conducted behavioral–biological surveys in 2008 and 2011 in 4 districts of Karnataka, India. We defined exposure to CM as low, medium (attended nongovernmental organization meeting or drop-in centre), or high (member of collective or peer group). We used regression analyses to explore whether exposure to CM was associated with the preceding outcomes. Pathway analyses explored the degree to which effects could be attributable to CM.Results. By the final survey, FSWs with high CM exposure were more likely to have been tested for HIV (adjusted odd ratio [AOR] = 25.13; 95% confidence interval [CI] = 13.07, 48.34) and to have used a condom at last sex with occasional clients (AOR = 4.74; 95% CI =  2.17, 10.37), repeat clients (AOR = 4.29; 95% CI = 2.24, 8.20), and regular partners (AOR = 2.80; 95% CI = 1.43, 5.45) than FSWs with low CM exposure. They were also less likely to be infected with gonorrhea or chlamydia (AOR = 0.53; 95% CI = 0.31, 0.87). Pathway analyses suggested CM acted above and beyond peer education; reduction in gonorrhea or chlamydia was attributable to CM.Conclusions. CM is a central part of HIV prevention programming among FSWs, empowering them to better negotiate condom use and access services, as well as address other concerns in their lives.HIV prevention strategies with female sex workers (FSWs) have traditionally relied on individual behavior change, involving peer educators, condom promotion, and provision of sexual health services.1,2 Over the past decade, there has been a growing recognition that HIV epidemics are “socially and culturally produced,”3 and that psychosocial and community-level processes underlie an individual’s ability to adopt safer sexual behaviors. This has influenced approaches to HIV prevention, with more attention being paid to structural and social factors (such as violence, stigma, and poverty) that shape individual-level risk behaviors (e.g., condom use) and interventions that are targeted toward contextual factors in the HIV risk environment.4–8Among FSW populations, community mobilization (CM) has been endorsed as one of the structural interventions that improve the risk environment, with it''s effectiveness in addressing health and social issues of poor and marginalized populations largely explained through “empowerment.”9–12 Such programs have been recognized in the Joint United Nations Programme on HIV/AIDS investment framework, which includes CM as a critical enabler to core programs.13 In contrast to peer education, which usually involves peers meeting FSWs in the field, talking to them about the program, about difficulties they are facing in their lives, about the importance of condom use, and about the clinics and drop-in centers and other program activities, CM involves bringing together FSWs of various typologies who are scattered and hidden across rural areas and towns through mobilization, participation, and empowerment processes, to provide them with the space and the opportunity to act together, to fight injustices against them, and to campaign for their rights. Thus, whereas peer education can be a fairly “top down” approach, CM is designed to be an inclusive process that is initiated and sustained by the community to bring about the changes they desire (e.g., reduction in violence) through the process of empowerment. Empowerment can be defined as “the processes by which those who have been denied the ability to make choices (disempowered) acquire such an ability.”14^(p437) Most empowerment approaches recognize a dynamic interplay between gaining internal skills and overcoming external barriers, often drawing upon a conceptual framework that distinguishes “power within” (for example, self-confidence or critical thinking skills that contribute to individual agency), “power to” (for example, the ability to make individual decisions that determine and demonstrate such agency), and “power with” (communal decisions, such as group solidarity or collective action, which acknowledge that positive change may often be effected by individuals working together, rather than alone).9,15,16 In the context of sex work, the principles of social solidarity and CM seek to shift the burden of safer sex negotiation from being solely that of an individual FSW to a concept that is collectively shared and owned by the SW community, by acknowledging the dynamics and inequalities between a FSW and her client and the owners, pimps, and madams of sex establishments where sex workers work.17The Sonagachi program in Kolkata in east India provided one of the first examples of a rights-based HIV prevention program for FSWs, focusing on the mobilization and empowerment of brothel-based sex workers, as well as engagement with power structures,12,18–20 with data suggesting that HIV prevalence remained much lower in this setting compared with FSWs elsewhere in India.19 More recently, a growing body of evidence has suggested that organizing FSWs into support groups and community-based organizations can help the community to collectively challenge factors contributing to their vulnerability, such as stigma, discrimination, poverty, housing instability, violence, and harassment.21–31 However, although studies have reported strong associations between CM and collective power, uptake of sexually transmitted infection (STI) services, and consistent condom use with clients,11,17,32–35 there remains a paucity of data examining the impact of CM on biological (HIV or STI) outcomes.India has an estimated 2.4 million people living with HIV.36 Karnataka state in south India has the fourth highest HIV prevalence in the country. HIV is predominantly transmitted heterosexually, with the prevalence of HIV previously exceeding 1% in the general population, and a prevalence of more than 30% among FSWs in some districts.37,38 Before 2003, there was little HIV prevention programming in Karnataka. The Karnataka Health Promotion Trust was established in 2003 as part of the India Avahan initiative, funded by the Bill & Melinda Gates foundation.39,40 The program aimed to slow the HIV epidemic by rapidly scaling up targeted HIV prevention programs, reaching more than 60 000 FSWs and 20 000 men who have sex with men and transgenders in 20 of the 30 districts in the state.Community mobilization and the empowerment of FSWs formed a core part of HIV prevention programming in Karnataka (Figure 1).21,29–31 The process of mobilization and empowerment was gradual, with later phases of the program building on previous phases, and each activity contributing to the mobilization of SWs. For example, in the early phase of the project, peer educators were recruited from the FSW community. FSWs were brought together, and safe drop-in centers were created to respond to FSWs’ need for somewhere safe to rest, dress up, and meet friends. The program organized events and meetings for FSWs together with clinical services in these drop-in centers. These services included the provision of the “gray pack,” which was supplied every 3 to 6 months for the periodic presumptive treatment of gonorrhea and Chlamydia (containing 1 g azithromycin and 400 mg cefixime). These drop-in centers, in turn, helped attract more SWs, which resulted in the centers becoming a space where FSWs could meet each other and share their experiences, which helped create a sense of solidarity. The program then worked to support and develop critical thinking among the FSW community, providing a forum where FSWs could discuss the difficulties in their lives and reflect on how they could work together to address the challenges they faced.Open in a separate windowFIGURE 1—Community mobilization activities of Karnataka Health Promotion Trust: Karnataka, India, 2003–2014.Note. DIC = drop-in center; FSW = female sex worker; STI = sexually transmitted infection.In the intensive phases of the program (2006–2008), FSWs built on their sense of solidarity and started to undertake collective action, working with policymakers, the police, government officials, human rights lawyers, and the media to address issues of stigma, discrimination, violence, and social inequity.21,31 This, in turn, gave birth to collectivization and the formation of community-based institutions, such as peer groups or collectives. In the maintenance phase (2008–2013), FSW community-based organizations were formed to enable the process of handing over ownership of the Avahan program to FSWs and to the state government by 2013, which is now complete.41A detailed analysis of the impact of Avahan on HIV and risk behavior has been conducted, and suggests that the combination HIV program had a significant impact on HIV prevalence in Karnataka.42 However, a key policy debate, especially given current resource constraints, has been whether it is necessary to include CM, collectivization, and empowerment components in FSW HIV prevention programming, which can be costly and time-consuming. Therefore, we examined the impact of CM on HIV and STI prevalence, HIV risk behaviors, and collective and individual power among FSWs in Karnataka, using secondary analyses of data from 2 rounds of behavioral–biological surveys conducted with FSWs in 2008 and 2011.