Improving oncology first-in-human and Window of opportunity informed consent forms through participant feedback.

BACKGROUND: Although patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to determine the patient-preferred presentation of important information in consent forms for these trials. METHODS: The study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial's consent form. The location of information in the consent forms was compared to the participants' suggestions for placement. RESULTS: 34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the "Risks" section.  3/5(60%) consents did this. CONCLUSIONS: Designing consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding.

Lack of Demographic Information in Total Hip Arthroplasty/Total Knee Arthroplasty Randomized Controlled Trial Publications.

BACKGROUND: The impact of social determinants of health (SDOH) has been documented in orthopaedic literature. However, there is a lack of data on the inclusion of these variables in orthopaedic studies. Our aim was to investigate how many total hip arthroplasties and total knee arthroplasties randomized controlled trials report SDOH variables such as race, ethnicity, insurance, income, and education within the manuscript. METHODS: A systematic review was conducted on a PubMed search for randomized controlled trials published from 2017 to 2019 in the Journal of Bone and Joint Surgery, Journal of Arthroplasty, Clinical Orthopaedics and Related Research, and Osteoarthritis and Cartilage. Data collected included publication year, type of surgery, and the inclusion of race, ethnicity, insurance, income, and education. RESULTS: Of the 72 manuscripts included in the study, 5.6% of the manuscripts mentioned race, 4.2% included race within the demographic table, and 1.4% included ethnicity in the demographic table. Overall, only 5 studies discussed any one of the variables studied and none included any SDOH variables in their multivariable regressions. There were no statistically significant differences on inclusion across journal year (P value = .78), journal name (P value = 1.00), or surgery type (P value = .555). CONCLUSION: Our findings identify a major shortcoming in the inclusion of SDOH variables in total knee arthroplasty/total hip arthroplasty publications. Their exclusion may be indirectly perpetuating disparities if research that does not use representative patient samples is used in creating health policies and national standards. LEVEL OF EVIDENCE: Level V.

Graduate students in public health predict their actual usage of different library services and resources quite accurately.

BACKGROUND: Public health students need to use different resources to those used by other health science students. OBJECTIVES: To compare how users expect to interact with library resources and services with how they reported actual interactions and expected future usage, to inform library planning. METHODS: During first semester orientation, a paper questionnaire was administered to graduate students (n = 25), followed by an end of semester questionnaire in a mandatory public health course. Differences (orientation vs. actual and actual vs. predicted future) were analysed using chi-square tests. RESULTS: Most graduate students utilized library resources as frequently as they anticipated at the semester's start. Regarding which library resources they would use, respondents' predictions during orientation were accurate. Respondent confidence in their abilities to use the library resources rose by the semester's end, and the group's expectations of using electronic books in the future semester increased significantly. DISCUSSION: Graduate students had realistic expectations when predicting their library resource usage and difficulties and most expected to value the quiet space as much as they did. CONCLUSION: Such tracking of group expectations, experience and predicted usage helps library managers' plan where support is required.

Longitudinal observations of expected and actual library resource usage and barriers experienced by public health students.

OBJECTIVE: This longitudinal observational study explored relationships between actual and expected usage of library resources as well as anticipated and encountered barriers to that usage among public health affiliates over the course of a semester. METHODS: School of Public Health master's degree students were sent questionnaires monthly throughout a semester that asked about usage of and barriers to library resources to examine changes over time. RESULTS: Most students utilized library resources less often than they predicted at the beginning of the semester and did not have accurate expectations about which library resources they would use. Although most students encountered no difficulties using library resources, those who did often had multiple problems and seldom sought library assistance. CONCLUSION: As School of Public Health master's students had unrealistically high expectations of library resource usage, librarians may need to manage students' expectations and assist in overcoming difficulties. Further studies across health sciences disciplines are needed to determine differences between different populations of users.

Residuals, sludge, and biosolids: Advancements in the field.

Advancements in the field of residuals, sludge, and biosolids have been made in 2019. This review outlines the major contributions of researchers that have been published in peer-reviewed journals and conference proceedings throughout 2019 and includes brief summaries from over 125 articles. The review is organized in sections including life cycle and risk assessments; characteristics, quality, and measurement including micropollutants, nanoparticles, pathogens, and metals; sludge treatment technologies including dewatering, digestion, composting, and wetlands; disposal and reuse including adsorbents, land application and agricultural uses, nutrient recovery, and innovative uses; odor and air emissions; and energy issues.

Biosolids and sludge management.

The advancements in the field of sludge and biosolids have been made over the past year. This review outlines the major contributions of researchers that have been published in peer-reviewed journals and conference proceedings throughout 2018. The review is organized in sections including regulatory developments and market analysis; analysis and quantification of characteristics including microconstituents and metals; treatment advances for the conversion of sludge to biosolids including pretreatment and sludge minimization, conditioning and dewatering, digestion, composting, and innovative technologies; product development and reuse including adsorbents and thermal products, agricultural and other uses, and innovative uses; odor and air emissions; and energy factors. PRACTITIONER POINTS: Summary of advances in the field of residuals and biosolids research in 2018. This review outlines the major contributions of researchers that have been published in peer-reviewed journals and conference proceedings. Topics covered range from regulation to innovation.

Randomized Double-Blind Study of the Safety and Immunogenicity of Standard-Dose Trivalent Inactivated Influenza Vaccine versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Hematopoietic Stem Cell Transplantation Patients.

Hematopoietic stem cell transplantation (HCT) survivors are less likely than matched healthy controls to mount a strong immune response to trivalent inactivated influenza vaccine (TIV). High-dose (HD) or standard-dose (SD) TIV were given to adult HCT subjects 18 years or older at least 6 months after transplantation. Subjects were randomized 2:1 to receive either the HD (60 µg hemagglutinin [HA]/strain/dose) or the SD (15 µg HA/strain/dose) TIV. Injection-site and systemic reactions were documented after each vaccination and immune responses were measured before and after each vaccination. A total of 44 subjects were enrolled (25 in year 1 and 19 in year 2), with 15 in the SD group and 29 in the HD group. The median time to vaccination after transplantation was 7.9 months (range, 6 to 106 months), the median age was 50 years (range, 19.6 to 73 years), and 61% were male. No differences in demographic or lab data were noted between groups; however, the HD group had higher median baseline total IgG level (676 versus 469 mg/dL, P = .025). No differences in individual injection-site or systemic reactions were noted between groups; however, more events of any injection-site symptom combined were reported in the HD group. No serious adverse events were attributed to vaccination. After vaccination, the HD group had a higher percentage of individuals with titers ≥1:40 and a higher geometric mean titer (GMT) against the H3N2 strain compared with that of the SD group. HD and SD TIV were found to be safe and well tolerated in adult HCT recipients. However, the HD group had higher frequency of injection-site reactions but the majority of the reactions were mild and resolved. The HD group had a higher percentage of individuals with post-vaccination titer ≥ 1:40 and GMT for H3N2 antigen, indicating better immunogenicity. These data support the need for a phase II immunogenicity trial in HCT recipients.

Effectiveness of mammography screening in reducing breast cancer mortality in women aged 39-49 years: a meta-analysis.

BACKGROUND: Mammography screening of women >50 years of age significantly reduces breast cancer mortality in randomized controlled trials (RCTs). We sought to evaluate the effectiveness of mammography screening in women aged 39-49 years in reducing breast cancer mortality and to discuss previously published meta-analyses. METHODS: PubMed/MEDLINE, OVID, COCHRANE, and Educational Resources Information Center (ERIC) databases were searched, and extracted references were reviewed. Dissertation abstracts and clinical trials databases available online were assessed to identify unpublished works. All assessments were independently done by two reviewers. All trials included were RCTs, published in English, included data on women aged 39-49, and reported relative risk (RR)/odds ratio (OR) or frequency data. RESULTS: Nine studies were identified: the Kopparberg, Ostergotland (The Two-County study), Health Insurance Plan (HIP), Canada, Stockholm, Gothenburg, Edinburgh, Age, and Malmo trials. The individual trials were quality assessed, and the data were extracted using predefined forms. Using the DerSimonian and Laird random effects model, the results from the seven RCTs with the highest quality score were combined, and a significant pooled RR estimate of 0.83 (95% confidence interval [CI] 0.72-0.97) was calculated. Post hoc sensitivity analyses excluding studies with randomization before 1980 caused a loss of statistical significance (RR 0.87, 95% CI: 0.56, 1.13). CONCLUSIONS: Mammography screenings are effective and generate a 17% reduction in breast cancer mortality in women 39-49 years of age. The quality of the trials varies, and providers should inform women in this age group about the positive and negative aspects of mammography screenings.