The immediate effect of osteopathic cervical spine mobilization on median nerve mechanosensitivity: A triple-blind,randomized, placebo-controlled trial

Background

Neurodynamics is a clinical medium for testing the mechanical sensitivity of peripheral nerves which innervate the tissues of both the upper and lower limb. Currently, there is paucity in the literature of neurodynamic testing in osteopathic research, and where there is research, these are often methodologically flawed, without the appropriate comparators, blinding and reliability testing.

Imaging Characteristics and First Experience of [<Superscript>68</Superscript>Ga]THP-PSMA,a Novel Probe for Rapid Kit-Based Ga-68 Labeling and PET Imaging: Comparative Analysis with [<Superscript>68</Superscript>Ga]PSMA I&amp;T

Purpose

[⁶⁸Ga]Trishydroxypyridinone (THP)–prostate-specific membrane antigen (PSMA) is a novel tracer that can be labeled in one step by cold reconstitution of a kit with unprocessed generator eluate, targeting PSMA via the lysine-urea-glutamate (KuE) motif. The aim of this study was to evaluate the human imaging characteristics of [⁶⁸Ga]THP-PSMA.

Procedures

[⁶⁸Ga]THP-PSMA positron emission tomography (PET)/x-ray computed tomography (CT) was performed in 25 patients with biochemical recurrence after radical prostatectomy for prostate cancer. Urinary and biliary excretion and tumor lesion uptake were quantified using standardized uptake values (SUVs). Imaging characteristics were assessed in terms of non-target organ uptake, background activity, target-to-background ratios (TBRs) of tumor lesions, and frequency of bladder halo artifacts. Findings were compared to a matched cohort of 25 patients undergoing PET/CT with the established agent [⁶⁸Ga]PSMA I&T.

Results

Physiologic uptake of [⁶⁸Ga]THP-PSMA was significantly lower in salivary glands (P?<?0.0001), liver (P?<?0.0001), spleen (P?<?0.0001), and kidneys (P?<?0.0001) than with [⁶⁸Ga]PSMA I&T. While biliary tracer excretion of [⁶⁸Ga]THP-PSMA was negligible, urinary tracer excretion of [⁶⁸Ga]THP-PSMA was fast, and significantly higher than for [⁶⁸Ga]PSMA I&T, contributing to a higher frequency of bladder artifacts. Malignant lesion uptake of [⁶⁸Ga]THP-PSMA assessed as either SUV or TBR was significantly lower than with [⁶⁸Ga]PSMA I&T.

Conclusion

[⁶⁸Ga]THP-PSMA yields suitable in vivo uptake characteristics. The simplified synthesis method for [⁶⁸Ga]THP-PSMA may facilitate wider application and higher patient throughput with PSMA imaging. However, direct intraindividual comparison studies are needed to assess the relative performance of [⁶⁸Ga]THP-PSMA vs other PSMA ligands in terms of clinical detection rate and image quality.

     

Pharmacokinetics,clot strength and safety of a new fibrinogen concentrate: randomized comparison with active control in congenital fibrinogen deficiency

Essentials

• Congenital afibrinogenemia causes a potentially life‐threatening bleeding and clotting tendency.
• Two human fibrinogen concentrates (HFCs) were compared in a randomized pharmacokinetic study.
• Bioequivalence was not shown for AUC_norm, which was significantly larger for the new HFC.
• Increases in clot strength were comparable, and no thromboses or deaths occurred in the study.

Summary

Background

Human fibrinogen concentrate (HFC) corrects fibrinogen deficiency in congenital a‐/hypofibrinogenemia.

Objectives

To assess pharmacokinetics (PK), effects on thromboelastometry maximum clot firmness (MCF), and safety of a new double virus‐inactivated/eliminated, highly purified HFC vs. active control.

Patients/Methods

In this multinational, randomized, phase II, open‐label, crossover study in 22 congenital afibrinogenemia patients aged ≥ 12 years, 70 mg kg^?1 of new HFC (FIBRYGA, Octapharma AG) or control (Haemocomplettan^® P/RiaSTAP?, CSL Behring GmbH) were administered, followed by crossover to the other concentrate. Fibrinogen activity, PK and MCF in plasma were assessed.

Results

The concentrates were not bioequivalent for the primary endpoint, AUC_norm (mean ratio, 1.196; 90% confidence interval [CI], 1.117, 1.281). Remaining PK parameters (C_maxnorm, IVR, t_1/2, MRT) reflected bioequivalence between concentrates, except for clearance (mean ratio, 0.836; 90% CI, 0.781, 0.895) and V_ss (mean ratio, 0.886; 90% CI, 0.791, 0.994). Mean AUC_norm was significantly larger for the new HFC (1.62 ± 0.45 vs. 1.38 ± 0.47 h kg g L^?1 mg^?1, P = 0.0001) and mean clearance was significantly slower (0.665 ± 0.197 vs. 0.804 ± 0.255 mL h^?1 kg^?1, P = 0.0002). Mean MCF increased from 0 mm to 9.68 mm (new HFC) and 10.00 mm (control) 1‐hour post‐infusion (mean difference, ?0.32 mm; 95% CI, ?1.70, 1.07, n.s.). No deaths, thromboses, viral seroconversions or serious related adverse events occurred.

Conclusions

Bioequivalence was not demonstrated for AUC_norm, clearance and V_ss. Larger AUC_norm and slower clearance were observed for the new HFC. Remaining pharmacokinetic parameters reflected bioequivalence to control. Safety profiles and increases in clot strength were comparable between concentrates.

     

What Do Healthcare Providers Know About Nutrition Support? A Survey of the Knowledge,Attitudes, and Practice of Pharmacists and Doctors Toward Nutrition Support in Malaysia

Background and Aims: Malnutrition is one of the health problems that can be prevented by appropriate nutrition care provided by healthcare providers. However, this practice is still lacking possibly because of the providers' inadequate knowledge. The aim of this study was to evaluate the self‐reported knowledge, attitudes, and practices of pharmacists and doctors toward nutrition support in a tertiary care hospital setting. Methods: A validated questionnaire was distributed to all the doctors and pharmacists working in a tertiary hospital in Penang, Malaysia. Seven individuals including academics, general surgeons, and pharmacists performed the face and content validity. The questionnaire was piloted using 24 healthcare providers at a different hospital. Result: Of 400 surveyed, 158 doctors and 72 pharmacists from various grades completed the questionnaire. More doctors (31.6%) than pharmacists (15.3%) reported adequate knowledge to perform patients' nutrition screening. However, in the knowledge assessment, pharmacists had a higher mean score (6.07 ± 1.77) than the doctors did (4.59 ± 1.87; P < .001), and most (70.4%) of them were grouped in the “average” score range. In addition, both pharmacists and doctors have ambivalent attitudes toward nutrition support. Only 31.3% stated that they perform nutrition screening on admission, and half of them performed nutrition assessment during hospitalization. Conclusion: Inappropriate nutrition care might be due to the lack of guidelines and insufficient knowledge among doctors and pharmacists. Special nutrition training and education for both pharmacists and doctors should be established.     

HIV Infection Among People Who Inject Drugs in the United States: Geographically Explained Variance Across Racial and Ethnic Groups

Objectives. We explored how variance in HIV infection is distributed across multiple geographical scales among people who inject drugs (PWID) in the United States, overall and within racial/ethnic groups.Methods. People who inject drugs (n = 9077) were recruited via respondent-driven sampling from 19 metropolitan statistical areas (MSAs) for the Centers for Disease Control and Prevention’s 2009 National HIV Behavioral Surveillance system. We used multilevel modeling to determine the percentage of variance in HIV infection explained by zip codes, counties, and MSAs where PWID lived, overall and for specific racial/ethnic groups.Results. Collectively, zip codes, counties, and MSAs explained 29% of variance in HIV infection. Within specific racial/ethnic groups, all 3 scales explained variance in HIV infection among non-Hispanic/Latino White PWID (4.3%, 0.2%, and 7.5%, respectively), MSAs explained variance among Hispanic/Latino PWID (10.1%), and counties explained variance among non-Hispanic/Latino Black PWID (6.9%).Conclusions. Exposure to potential determinants of HIV infection at zip codes, counties, and MSAs may vary for different racial/ethnic groups of PWID, and may reveal opportunities to identify and ameliorate intraracial inequities in exposure to determinants of HIV infection at these geographical scales.Since the mid-1990s, there has been an increase in studies evaluating whether features of the social, economic, physical, and political environment (i.e., place characteristics) affect health. This focus on place characteristics is evident in the development of theories conceptualizing place characteristics as health determinants,1–3 in the use of geospatial and systematic social observation methods to measure place characteristics,4–10 in the application of multilevel modeling to assess the potential impacts of place characteristics,11–18 and in the recognition that interventions should not solely encourage individual behavior change but also modify environmental features.3,16,19Literature emerging from this field of research demonstrates that place characteristics operationalized at different geographical scales influence psychosocial processes and individual behaviors that increase vulnerability to several health outcomes. With rare exception,20–24 however, studies of place and health typically assess the potential influence of place characteristics at a single geographical scale and do not simultaneously evaluate characteristics of other geographical scales. For example, several studies, including our own,25,26 sample participants from a single metropolitan statistical area (MSA) to assess the relationships of census tract characteristics to health, without sampling participants from multiple MSAs to simultaneously assess the relationships of tract-, county-, and MSA-level characteristics to health.25–32 The decision to focus on characteristics of a single geographical scale may arise because of data availability, cost constraints, or feasibility.Studies of place and health that focus on a single geographical scale, however, may misspecify relationships and hinder the exploration of causal pathways in 2 ways. First, studies that focus on features measured at a single geographical scale may overlook potential health determinants that are operationalized at other geographical scales. For instance, research assessing the relationships of features of neighborhoods (e.g., economic deprivation, racial/ethnic composition, policing practices, and “crackdowns”) cannot determine the influence of policies, laws, and governmental expenditures that are operationalized at county, MSA, and state levels, and shape neighborhood environments. Second, studies of features of a single geographical scale cannot determine whether relationships between characteristics operating at one geographical scale are confounded, mediated, or modified by characteristics of other geographic scales.3,16,33 The possibility that at least 1 of these mechanisms can occur has been demonstrated in research conducted by Warner and Gomez, which suggests that, among Black women diagnosed with breast cancer, residing in census blocks with high concentrations of Black residents is more protective against mortality in more racially segregated metropolitan areas than less racially segregated metropolitan areas.34In addition, research assessing the association of place-based factors with health outcomes rarely highlights the extent to which variance in health outcomes is explained by place and place-based factors. Determining whether health outcomes vary geographically can generate hypotheses about inequities in exposure to potential place-based determinants of health, and thereby inform how interventions and social policies are developed and spatially concentrated.35The present study illustrates the generative possibilities of extending research beyond a single geographical scale by achieving 2 primary aims. The study’s first aim is to determine the share of total variance in HIV infection that is apportioned to zip codes, counties, and MSAs among people who inject drugs (PWID). In the United States, PWID account for 22% of people living with HIV,36 and a growing body of literature demonstrates that features of neighborhoods such as census-tract racial composition and block-level social or physical disorder are associated with HIV-related outcomes among PWID,37,38 as are features of MSAs, including drug-related law enforcement, income inequality, residential segregation, and health service access.39–41 Revealing the geographical scale to which variance in HIV infection is apportioned among PWID can stimulate hypotheses about inequities in exposure to place-based determinants of HIV and inform the development and tailoring of place-based interventions. For example, finding high MSA-level variance in HIV infection may support analyses of whether MSA-level variations in health care service access predict variance in HIV serostatus and, if they do, support interventions to increase health care access in low-access MSAs. In contrast, if little to no variance in HIV infection among PWID is apportioned to MSAs, PWID may encounter a relatively uniform exposure to health care service access.Previous studies have found that variance in some health outcomes vary across racial/ethnic groups.42,43 The second aim of this study therefore tests the hypothesis that variance in HIV infection will differ within each of 3 racial/ethnic groups of PWID: non-Hispanic/Latino Whites, non-Hispanic/Latino Blacks, and Hispanics/Latinos.