ObjectiveTo quantify patients’ preferences for physical therapy programmes after a lower extremity fracture and determine patient factors associated with preference variation.DesignDiscrete choice ...experiment.SettingLevel I trauma centre.ParticipantsOne hundred fifty-one adult (≥18 years old) patients with lower extremity fractures treated operatively.InterventionPatients were given hypothetical scenarios and asked to select their preferred therapy course when comparing cost, mobility, long-term pain, session duration, and treatment setting.Main outcome measuresA multinomial logit model was used to determine the relative importance and willingness to pay for each attribute.ResultsMobility was of greatest relative importance (45%, 95% CI: 40% to 49%), more than cost (23%, 95% CI: 19% to 27%), long-term pain (19%, 95% CI: 16% to 23%), therapy session duration (12%, 95% CI: 9% to 5%) or setting (1%, 95% CI: 0.2% to 2%). Patients were willing to pay US$142 more per session to return to their preinjury mobility level (95% CI: US$103 to US$182). Willingness to pay for improved mobility was higher for women, patients aged 70 years and older, those with bachelor’s degrees or higher and those living in less-deprived areas. Patients were willing to pay US$72 (95% CI: US$50 to US$93) more per session to reduce pain from severe to mild. Patients were indifferent between formal and independent home therapy (willingness to pay: −US$12, 95% CI: −US$33 to US$9).ConclusionsPatients with lower extremity fractures highly value recovering mobility and are willing to pay more for postoperative physical therapy programmes that facilitate returning to their pre-injury mobility level. These patient preferences might be useful when prescribing and designing new techniques for postoperative therapy.
•This risk score model predicts postoperative deep infection in patients with open tibia shaft fractures treated with intramedullary nails.•Independent risk factors specific for postoperative deep ...infection in open tibial shaft fractures treated with an intramedullary nail are identified.•The prediction model has the ability to predict a broad range of risk.•The model allows a physician to discuss the injury and any risk for infection with the patient at the time of initial presentation.
To identify deep infection risk factors in patients with open tibial shaft fractures and to develop a scoring algorithm to predict the baseline deep infection risk in this patient population.
A retrospective cohort study conducted at a single academic trauma center identified patients with open tibial shaft fractures treated with intramedullary nail fixation from December 2006 to October 2020. The primary outcome was a deep surgical site infection requiring surgical debridement. The outcome was identified by Current Procedural Terminology codes and confirmed with a medical chart review documenting evidence of a tibial draining wound or sinus tract.
Deep surgical site infection occurred in 13% of patients (97/769). Factors that predicted deep surgical site infection were identified. Gustilo-Anderson type IIIB or IIIC was the strongest predictor with a 12-fold increase in the odds of deep infection (OR 11.8, p < 0.001). Additional factors included age >40 years (OR 1.7, p = 0.03), American Society of Anesthesiologists score ≥3 (OR 1.9, p < 0.01), Gustilo-Anderson type IIIA vs. type I or II (OR 2.8, p = 0.004), and gunshot wounds (OR 2.9, p = 0.02). The risk scoring model predicted patients who would develop an infection with an acceptable level of accuracy (AUC 0.79). The risk score categorized patients from a low probability of deep infection 2%–6% with <10 points to high risk (58%–69%) with >40 points.
This risk score model predicts deep postoperative infection in patients with open tibial shaft fractures treated with intramedullary nails. The ability to accurately estimate deep infection risk at the time of presentation might aid patient expectation management and allow clinicians to focus infection prevention strategies on the high-risk subset of this population.
•Inflammation is linked to schizophrenia.•Antigliadin antibodies (AGA IgG) against a protein found in wheat barley and rye have been reported to be higher in schizophrenia compared to healthy ...controls, possibly a subgroup of schizophrenia with related inflammation.•In a sample of 100 people with schizophrenia we found that TNFα and IL-Iβ were over twofold higher in people with schizophrenia who are positive to AGA IgG compared to schizophrenia participants who did not have positivity to AGA IgG.•We found that there was a significant positive correlation between AGA IgG and the TNF-α and IL-Iβ, suggesting a robust association of AGA IgG antibodies with peripheral proinflammatory markers.•These data reflect inflammation heterogeneity in schizophrenia. People with schizophrenia having higher levels of AGA IgG show higher levels of peripheral inflammation and may define a group with distinct pathophysiology and potentially novel treatment targets.
Altered immune function and inflammation are seen in schizophrenia, however, peripheral inflammatory markers are not consistently elevated in all people, suggesting inflammation may be present only in a subgroup. We measured TNF-α and IL-Iβ in 100 people with schizophrenia or schizoaffective disorder and correlated these with antibodies to gliadin, a protein found in wheat, barley and rye that has been found to be elevated in some people with schizophrenia. We hypothesized that higher peripheral antigliadin antibodies (AGA IgG) would be associated with higher peripheral inflammation as measured by TNF-α and IL-1β. Mean log transformed values of TNF-α, (p=.029) and IL-1β (p=.016) were over twofold higher in people with schizophrenia who had high levels of AGA IgG (≥7 U) compared to those who did not have positivity to AGA IgG. We found a significant positive correlation between AGA IgG and the log transformed TNF-α (r=0.42, p<.0001) as well as IL-Iβ (r=0.51, p<.0001). The relationship was independent of cigarette smoking, body mass index and antipsychotic medications. People with schizophrenia having higher levels of AGA IgG show higher levels of peripheral inflammation and may define a subgroup with distinct pathophysiology and potentially novel treatment targets.
Inflammation may play a role in schizophrenia; however, subgroups with immune regulation dysfunction may serve as distinct illness phenotypes with potential different treatment and prevention ...strategies. Emerging data show that about 30% of people with schizophrenia have elevated antigliadin antibodies of the IgG type, representing a possible subgroup of schizophrenia patients with immune involvement. Also, recent data have shown a high correlation of IgG-mediated antibodies between the periphery and cerebral spinal fluid in schizophrenia but not healthy controls, particularly AGA IgG suggesting that these antibodies may be crossing the blood-brain barrier with resulting neuroinflammation. Proton magnetic resonance spectroscopy (MRS) is a non-invasive technique that allows the quantification of certain neurochemicals
that may proxy inflammation in the brain such as myoinositol and choline-containing compounds (glycerophosphorylcholine and phosphorylcholine). The objective of this exploratory study was to examine the relationship between serum AGA IgG levels and MRS neurochemical levels. We hypothesized that higher AGA IgG levels would be associated with higher levels of myoinositol and choline-containing compounds (glycerophosphorylcholine plus phosphorylcholine; GPC + PC) in the anterior cingulate cortex. Thirty-three participants with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder had blood drawn and underwent neuroimaging using MRS within 9 months. We found that 10/33 (30%) had positive AGA IgG (≥20 U) similar to previous findings. While there were no significant differences in myoinositol and GPC + PC levels between patients with and without AGA IgG positivity, there were significant relationships between both myoinositol (
= 0.475,
= 0.007) and GPC + PC (
= 0.36,
= 0.045) with AGA IgG levels. This study shows a possible connection of AGA IgG antibodies to putative brain inflammation as measured by MRS in schizophrenia.
Approximately one-third of people with schizophrenia have elevated levels of anti-gliadin antibodies of the immunoglobulin G type (AGA IgG) — a higher rate than seen in healthy controls. We performed ...the first double-blind clinical trial of gluten-free versus gluten-containing diets in a subset of patients with schizophrenia who were positive for AGA IgG.
In this pilot feasibility study, 16 participants with schizophrenia or schizoaffective disorder who had elevated AGA IgG (≥ 20 U) but were negative for celiac disease were admitted to an inpatient unit for a 5-week trial. All participants received standardized gluten-free meals and were randomized in a double-blind fashion to receive a shake containing 10 g of gluten flour or 10 g of rice flour each day. Participants were rated for psychiatric, cognitive and gastrointestinal symptoms at baseline and endpoint.
Of the 16 participants, 14 completed the 5-week trial (2 discontinued early for administrative reasons). Compared with participants on the gluten-containing diet, participants on the gluten-free diet showed improvement on the Clinical Global Impressions scale (Cohen d = –0.75) and in negative symptoms (Cohen d = –0.53). We noted no improvement in positive or global cognitive symptoms, but did observe an improvement in attention favouring the gluten-free diet (Cohen d = 0.60). Robust improvements in gastrointestinal adverse effects occurred in the gluten-free group relative to the glutencontaining group. Adverse effects were similar between groups.
This study was limited by its small sample size; larger studies are needed.
This feasibility study suggests that removal of gluten from the diet is associated with improvement in psychiatric and gastrointestinal symptoms in people with schizophrenia or schizoaffective disorder.
Physical and psychological impairment resulting from traumatic injuries is often significant and affects employment and functional independence. Extremity trauma has been shown to negatively affect ...long-term self-reported physical function, the ability to work, and participation in recreational activities and contributes to increased rates of anxiety and/or depression. High pain levels early in the recovery process and psychosocial factors play a prominent role in recovery after traumatic lower extremity injury. Cognitive-behavioral therapy pain programs have been shown to mitigate these effects. However, patient access issues related to financial and transportation constraints and the competing demands of treatment focused on the physical sequelae of traumatic injury limit patient participation in this treatment modality. This article describes a telephone-delivered cognitive-behavioral-based physical therapy (CBPT-Trauma) program and design of a multicenter trial to determine its effectiveness after lower extremity trauma. Three hundred twenty-five patients from 7 Level 1 trauma centers were randomized to CBPT-Trauma or an education program after hospital discharge. The primary hypothesis is that compared with patients who receive an education program, patients who receive the CBPT-Trauma program will have improved physical function, pain, and physical and mental health at 12 months after hospital discharge.
At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating ...Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment.
The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020.
All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7–121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment.
A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.
Trial Registration: clinicaltrials.gov: NCT03523962.
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