Difference In Percentage Of Participants Research Articles

Disparate kinetics in immune response of two different Haemophilus influenzae type b conjugate vaccines: Immunogenicity and safety observations from a randomized controlled phase IV study in healthy infants and toddlers using a 2+1 schedule

ABSTRACT Since the introduction of Haemophilus Influenzae type b (Hib) conjugate vaccines, invasive Hib disease has strongly declined worldwide, yet continued control of Hib disease remains important. In Europe, currently three different hexavalent combination vaccines containing Hib conjugates are marketed. In this phase IV, single-blind, randomized, controlled, multi-country study (NCT04535037), we aimed to compare, in a 2 + 1 vaccination schedule, the immunogenicity and safety and show non-inferiority, as well as superiority, of DTPa-HBV-IPV/Hib (Ih group) versus DTaP5-HB-IPV-Hib (Va group) in terms of anti-polyribosylribitol phosphate (PRP) antibody geometric mean concentrations (GMCs) and proportion of participants reaching anti-PRP antibody concentrations greater than or equal to a threshold of 5 µg/mL. One month after the booster vaccination, the anti-PRP antibody GMC ratio (Ih group/Va group) was 0.917 (95% CI: 0.710–1.185), meeting the non-inferiority criteria. The difference in percentage of participants (Ih group – Va group) reaching GMCs ≥5 µg/mL was -6.3% (95% CI: -14.1% to 1.5%), not reaching the predefined non-inferiority threshold. Interestingly, a slightly higher post-booster antibody avidity was observed in the Ih group versus the Va group. Both vaccines were well tolerated, and no safety concerns were raised. This study illustrates the different kinetics of the anti-PRP antibody response post-primary and post-booster using the two vaccines containing different Hib conjugates and indicates a potential differential impact of concomitant vaccinations on the anti-PRP responses. The clinical implications of these differences should be further studied.

Women Veterans' Experiences of Harassment and Perceptions of Veterans Affairs Health Care Settings During a National Anti-Harassment Campaign.

In 2017, Veterans Health Administration (VA) launched a social marketing and training campaign to address harassment of women veterans at VA health care facilities. We assessed women veterans' experiences of harassment, reported perpetrators of harassment, and perceptions of VA in 2017 (before campaign launch) and 2018 (1year after campaign implementation). We administered surveys to women veterans attending primary care appointments (2017, n=1,300; 2018, n=1,711). Participants reported whether they experienced sexual harassment (e.g., catcalls) and gender harassment (e.g., questioning women's veteran status) from patients and/or staff at VA in the past 6months. They also indicated whether they felt welcome, felt safe, and believed the VA is working to address harassment. We compared variables in 2017 versus 2018 with χ2 analyses, adjusting for facility-level clustering. There were no significant differences in percentages of participants reporting sexual harassment (20% vs. 17%) or gender harassment (11% vs. 11%) in 2017 versus 2018. Men veterans were the most frequently named perpetrators, but participants also reported harassment from staff. Participant beliefs that VA is working to address harassment significantly improved from 2017 to 2018 (52% vs. 57%; p=.05). One year after campaign launch, women veterans continued to experience harassment while accessing VA health care services. Findings confirm that ongoing efforts to address and monitor both staff- and patient-perpetrated harassment are essential. Results have implications for future anti-harassment intervention design and implementation and highlight additional opportunities for investigation.

Reducing Asthma Attacks in Children Using Exhaled Nitric Oxide as a Biomarker to Inform Treatment Strategy – A Randomised Trial

Background: The benefit of Fractional Exhaled Nitric Oxide (FeNO) in guiding asthma treatment is uncertain. Our hypothesis was that FeNO plus symptom-guided treatment reduces exacerbations in children with asthma compared to symptom-guided treatment alone. Methods: A multicentre randomised controlled trial recruited 6-15 year olds with asthma treated with inhaled corticosteroids (ICS) with an exacerbation in the previous year. Randomisation was to asthma treatment guided by FeNO plus symptoms (intervention) or by symptoms only (standard care). A web-based algorithm using symptom control, ICS adherence, current treatment and (within the intervention group) FeNO gave treatment recommendations. Participants attended assessments 3, 6, 9 and 12-months post-randomisation. The primary outcome was exacerbation requiring oral corticosteroid over the 12 months post-randomisation. Findings: There were 509 children recruited. At randomisation, the mean (SD) age was 10∙1y (2.6), median (IQR) FeNO 21 ppb (10, 48), mean (SD) %FEV 1 90% (18), 56% received ≤400 microg budesonide equivalent ICS and 50% had controlled symptoms. The primary outcome occurred in 123/255 (48%) of the intervention group and 129/251 (51%) of the standard care group. The adjusted difference in percentage of participants who received the intervention where the primary outcome occurred exacerbation compared to those receiving standard care was -3∙13% (95% CI: -11∙9% to 5∙6%). In adjusted intention-to-treat analysis, the odds ratio (OR) for primary outcome was 0 ∙88 [95%CI 0∙61 to 1∙27]. In 377 of 1771 assessments, the algorithm recommendation was not followed. In complier average causal effect analysis, adjusting for algorithm adherence, the OR for those fully adherent was 0∙82 [95% CI 0∙48 to 1∙41]. There were no differences in secondary outcomes between groups. Interpretation: In this exacerbation-prone population, adding FeNO to symptom-guided treatment did not reduce exacerbations. Trial Registration: ISRCTN number #67875351. Funding: This study was funded by the Efficacy and Mechanisms Evaluation programme of the National Institute for Health Research (reference 15-18-14). Declaration of Interest: David Price has board membership with AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Sanofi Genzyme, Thermofisher; consultancy agreements with Airway Vista Secretariat, AstraZeneca, Boehringer Ingelheim, Chiesi, EPG Communication Holdings Ltd, FIECON Ltd, Fieldwork International, GlaxoSmithKline, Mylan, Mundipharma, Novartis, OM Pharma SA, PeerVoice, Phadia AB, Spirosure Inc, Strategic North Limited, Synapse Research Management Partners S.L., Talos Health Solutions, Theravance and WebMD Global LLC; grants and unrestricted funding for investigator-initiated studies (conducted through Observational and Pragmatic Research Institute Pte Ltd) from AstraZeneca, Boehringer Ingelheim, Chiesi, Mylan, Novartis, Regeneron Pharmaceuticals, Respiratory Effectiveness Group, Sanofi Genzyme, Theravance and UK National Health Service; payment for lectures/speaking engagements from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, GlaxoSmithKline, Kyorin, Mylan, Mundipharma, Novartis, Regeneron Pharmaceuticals and Sanofi Genzyme; payment for travel/accommodation/meeting expenses from AstraZeneca, Boehringer Ingelheim, Mundipharma, Mylan, Novartis, Thermofisher; stock/stock options from AKL Research and Development Ltd which produces phytopharmaceuticals; owns 74% of the social enterprise Optimum Patient Care Ltd (Australia and UK) and 92.61% of Observational and Pragmatic Research Institute Pte Ltd (Singapore); 5% shareholding in Timestamp which develops adherence monitoring technology; is peer reviewer for grant committees of the UK Efficacy and Mechanism Evaluation programme, and Health Technology Assessment; and was an expert witness for GlaxoSmithKline. Ethical Approval: The study was approved by the North of Scotland Research Ethics Committee (16/NS/0106).

Local Anesthesia With General Anesthesia for Pediatric Bone Marrow Procedures.

Pediatric patients with cancer undergo repeated painful procedures, including bone marrow aspirations and biopsies (BMABs). Optimal management of procedure-related pain can reduce discomfort, anxiety, and distress. Children with neuroblastoma were randomly assigned to 1 of 2 arms on a prospective, single-blind, crossover trial conducted at Memorial Sloan Kettering Cancer Center from October 2016 to January 2018 (www.clinicaltrials.gov, identifier NCT02924324). Participants underwent 2 sequential BMABs: one with general anesthesia (GA) alone, the other with GA plus local anesthesia (LA) (GA + LA). The objective was to assess procedure-related pain and its interference with quality of life (QoL) with GA versus GA + LA. Primary outcome was percentage of participants requiring postprocedural opioids. Secondary outcomes were total opioid and nonopioid analgesics, pain scores, time to first analgesic, QoL, and toxicity. Management of postprocedural pain was standardized. Of 56 participants randomly assigned (3-16.5 years old), 46 completed both procedures. There was no significant difference in percentage of participants requiring opioids with GA versus GA + LA (24% vs 20%, P = .5). Pain scores in the recovery room were significantly lower for GA + LA versus GA (median [IQR]: 0 [0-2] vs 2 [0-4], P = .002). There were no statistically significant differences in total opioid or nonopioid analgesic, 6- and 24-hour pain scores, median time to first analgesic, or pain interference. No adverse events occurred. LA was associated with significant improvement in pain scores in the immediate recovery period. LA did not reduce postprocedural opioid use, nor did it improve QoL for patients undergoing BMAB with GA.

Gestational Weight Gain: Results from the Delta Healthy Sprouts Comparative Impact Trial.

Introduction. Delta Healthy Sprouts trial was designed to test the comparative impact of two home visiting programs on weight status, dietary intake, and health behaviors of Southern African American women and their infants. Results pertaining to the primary outcome, gestational weight gain, are reported. Methods. Participants (n = 82), enrolled early in their second trimester of pregnancy, were randomly assigned to one of two treatment arms. Gestational weight gain, measured at six monthly home visits, was calculated by subtracting measured weight at each visit from self-reported prepregnancy weight. Weight gain was classified as under, within, or exceeding the Institute of Medicine recommendations based on prepregnancy body mass index. Chi-square tests and generalized linear mixed models were used to test for significant differences in percentages of participants within recommended weight gain ranges. Results. Differences in percentages of participants within the gestational weight gain guidelines were not significant between treatment arms across all visits. Conclusions. Enhancing the gestational nutrition and physical activity components of an existing home visiting program is feasible in a high risk population of primarily low income African American women. The impact of these enhancements on appropriate gestational weight gain is questionable given the more basic living needs of such women. This trial is registered with ClinicalTrials.gov NCT01746394, registered 4 December 2012.

Older Adults and Technology Adoption

Access to computers and the Internet is a major public policy concern as technology has become a significant aspect of economic, social and health equity. Recent data suggest that although computer and Internet use is lower among older, as compared to younger adults access is increasing among older people. This paper examines changes in use of computers and the Internet over time (2000–2002 and 2006–2007) among two samples (N=424) of older adults ranging in age from 50–85 yrs. Data are also reported on changes in attitudes towards computers and how adoption is influenced by attitudes and demographic characteristics. Technology adoption and attitudes towards computers were assessed via questionnaire. Over time, although there was no difference in percentage of participants who had computer experience, both breadth of computer use and Internet use increased. Participants from the more recent time point also reported more comfort with computers. The data also indicated that age, education, and comfort with computers predicted breadth of computer and Internet use. Understanding factors that influence access is important to the development of strategies to close the gap between adopters and non-adopters.