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Cureus Feb 2024Background Infection in orthopedic surgery is one of the most dreaded complications. It is associated with prolonged morbidity, disability, and increased mortality. One...
Background Infection in orthopedic surgery is one of the most dreaded complications. It is associated with prolonged morbidity, disability, and increased mortality. One of the cornerstones of the prevention of infections is antibiotic prophylaxis. This study assessed the practice of antibiotic prophylaxis in arthroplasty surgeries in our local hospital. Methods One hundred and seventy-one elective joint replacement patients were retrospectively analyzed for documentation of antibiotic plan in postoperative instruction, choice of antibiotic, dose, and dosage. Compliance with the dosage (duration and frequency) of antibiotic prophylaxis was compared among patients who underwent different operations, among patients whose operation notes had antibiotics plans, and among those patients whose operation notes lacked this information. Results Ninety-six females and 75 males with a mean age of 71.4±9.8 years who underwent hip replacement, knee replacement, or shoulder replacement were included in this study. Preoperative and postoperative antibiotics were received by 100% and 94.7% of patients, respectively. In 19.3%, there was no instruction about postoperative antibiotics while 4% missed at least one postoperative dose. The dosage of postoperative prophylactic antibiotics was variable as 26.3% of the patients experienced delayed administration of doses. Not having intravenous access, failure to prescribe antibiotics, and prescribing antibiotics in the "once only" rather than "regular medication" section of the medication chart were the reasons for improper timing of antibiotic doses. Observing surgical safety checklist was effective in ensuring preoperative antibiotic administration, whereas failing to document antibiotic plan in operation note was associated with poor compliance with postoperative dosage. Interprofessional participation is crucial to compliance with antibiotic prophylaxis practice. Conclusion This study identified key areas for improvement in our antibiotics prophylaxis practice. It resulted in implementing strategies to improve staff's awareness about the importance of timely administration of prophylactic antibiotics and proper documentation by all team members.
PubMed: 38481888
DOI: 10.7759/cureus.54075 -
BMC Pediatrics Mar 2024Achieving universal health coverage includes ensuring that children have access to vaccines that are of high quality, safe, efficacious, and affordable. The Immunisation...
BACKGROUND
Achieving universal health coverage includes ensuring that children have access to vaccines that are of high quality, safe, efficacious, and affordable. The Immunisation Agenda 2030 aims to expand services to zero-dose and incompletely vaccinated children and reduce immunisation rate disparities as a contribution to vaccination equity. This study explored the factors influencing full vaccination status among children aged 12 - 23 months in a rural district of the Upper East Region of Ghana.
METHODS
A population-based cross-sectional study was conducted among carers of children aged 12 -23 months in the Kassena Nankana West district. A multistage sampling technique was used to select 360 carers. Information regarding the vaccination status of children was gathered through a combination of children's health record books and carers' recollections. Information on potential determinants was also systematically collected for analysis in Stata version 15.0.
RESULTS
The results showed that 76.9% (95% CI: 72.3 - 81.0) of children had full vaccinations per the national schedule. All children received at least one vaccination. A higher percentage of carers with incompletely vaccinated children reported that they had travelled with their children as the primary reason for missing certain vaccine doses. Full vaccination status was significantly associated with secondary (aOR = 2.60; 95% CI: 1.20-5.63) and tertiary (aOR = 3.98, 95% CI: 1.34-11.84) maternal educational level, being in a partnership relationship (aOR = 2.09, 95% CI: 1.03-4.25), and residing in close proximity to healthcare facilities (aOR = 0.41, 95% CI: 0.21-0.80).
CONCLUSIONS
Our study found that nearly one-quarter of children aged 12-23 months in the study setting are underserved with vaccination services for a variety of reasons. Effectively reaching these children will require strengthening health systems, including eliminating vaccine shortages, addressing the unique challenges faced by unmarried women with children aged 12-23 months, and improving accessibility to vaccination services.
Topics: Child; Humans; Female; Infant; Cross-Sectional Studies; Ghana; Vaccination; Vaccines; Immunization
PubMed: 38459467
DOI: 10.1186/s12887-024-04662-w -
The Pediatric Infectious Disease Journal Jun 2024Global pediatric immunization programs with pneumococcal conjugate vaccines (PCVs) have reduced vaccine-type pneumococcal disease, but a substantial disease burden of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Global pediatric immunization programs with pneumococcal conjugate vaccines (PCVs) have reduced vaccine-type pneumococcal disease, but a substantial disease burden of non-PCV serotypes remains.
METHODS
This phase 3, randomized (1:1), double-blind study evaluated safety and immunogenicity of 20-valent PCV (PCV20) relative to 13-valent PCV (PCV13) in healthy infants. Participants received 2 infant doses and a toddler dose of PCV20 or PCV13, with diphtheria-tetanus-acellular pertussis combination vaccine at all doses and measles, mumps, rubella and varicella vaccines at the toddler dose. Primary pneumococcal immunogenicity objectives were to demonstrate noninferiority (NI) of PCV20 to PCV13 for immunoglobulin G geometric mean concentrations after infant and toddler doses and percentages of participants with predefined serotype-specific immunoglobulin G concentrations after infant doses. Safety endpoints included local reactions, systemic events and adverse events.
RESULTS
Overall, 1204 participants were vaccinated (PCV20, n = 601; PCV13, n = 603). One month after the toddler dose, 19/20 serotypes met NI for immunoglobulin G geometric mean concentrations; serotype 6B narrowly missed NI [PCV20/PCV13 geometric mean ratio: 0.57 (2-sided 95% confidence interval: 0.48-0.67); NI criterion: lower 2-sided 95% confidence interval >0.5]. Sixteen/twenty serotypes met NI for ≥1 primary objective after 2 infant doses. PCV20 induced robust opsonophagocytic activity, and boosting responses were observed for all vaccine serotypes, including those missing statistical NI. The safety/tolerability profile of PCV20 was like that of PCV13.
CONCLUSIONS
PCV20 3-dose series in infants was safe and elicited robust immune responses. Based on these results and PCV13 experience, PCV20 3-dose series is expected to be protective for all 20 vaccine serotypes. NCT04546425.
Topics: Humans; Pneumococcal Vaccines; Infant; Double-Blind Method; Male; Female; Antibodies, Bacterial; Vaccines, Conjugate; Immunogenicity, Vaccine; Measles-Mumps-Rubella Vaccine; Pneumococcal Infections; Immunoglobulin G; Chickenpox Vaccine; Immunization Schedule; Streptococcus pneumoniae; Child, Preschool; Diphtheria-Tetanus-acellular Pertussis Vaccines; Vaccines, Combined
PubMed: 38456705
DOI: 10.1097/INF.0000000000004300 -
Neurology and Therapy Jun 2024Long-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2 medication clusters in a randomized...
Assessing the Long-Term (48-Week) Effectiveness, Safety, and Tolerability of Fremanezumab in Migraine in Real Life: Insights from the Multicenter, Prospective, FRIEND3 Study.
INTRODUCTION
Long-term (1-year) fremanezumab treatment proved to be effective, safe, and well tolerated in individuals with migraine and < 2 medication clusters in a randomized controlled trial (RCT). We aimed to assess real-world evidence (RWE), long-term effectiveness, tolerability, and safety of fremanezumab in people with high-frequency episodic migraine (HFEM) or chronic migraine (CM) with > 3 treatment failures and various comorbidities.
METHODS
A 48-week, prospective, multicenter (n = 26), cohort study assessed fremanezumab's effectiveness, safety, and tolerability in consecutive adults with HFEM or CM with > 3 treatment failures. Primary endpoint was variation from baseline in monthly migraine days (MMD) in HFEM and monthly headache days (MHD) in CM at weeks 45-48. Secondary endpoints were changes in monthly analgesic medications, Numerical Rating Scale (NRS), Headache Impact Test (HIT-6), and the Migraine Disability Assessment Scale (MIDAS) scores and ≥ 50%, ≥ 75%, and 100% responder rates.
RESULTS
Of 533 participants who had received ≥ 1 fremanezumab dose, 130 were treated for ≥ 48 weeks and considered for effectiveness analysis. No participant missed any treatment dosage every other consecutive month during the 12-month period.
PRIMARY ENDPOINT
fremanezumab significantly (p < 0.001) reduced both MMD (- 6.4) in HFEM and MHD (- 14.5) in CM. Secondary endpoints: a significant reduction (p < 0.001) was observed in monthly analgesic medications (HFEM - 6.0; CM -16.5), NRS (HFEM - 3.4; CM - 3.4), HIT-6 (HFEM - 16.9; CM - 17.9) and MIDAS score (HFEM - 50.4; CM - 76.6). The ≥ 50%, ≥ 75%, and 100% response rates to fremanezumab were 75.5%, 36.7%, and 2% in HFEM and 71.6%, 44.4%, and 3.7% in CM. Corresponding response rates were 60.5%, 37.2%, and 2.3% in individuals with psychiatric comorbidities, 74.2%, 50%, and 4.8% in CM with medication overuse, and 60.9%, 39.1%, and 4.3% in CM with medication overuse and psychiatric comorbidities. Mild and transient treatment-emergent adverse events occurred in 7.8% of the participants. No subject discontinued the treatment for any reason.
CONCLUSION
This RWE study documents that long-term fremanezumab treatment is highly effective and remarkably well tolerated in subjects with HFEM or CM with multiple (> 3) therapeutic failures, even in the presence of concomitant medication overuse, psychiatric comorbidities, or both. The effectiveness-to-tolerability ratio appears to be better in RWE than in RCTs.
PubMed: 38451463
DOI: 10.1007/s40120-024-00591-z -
Contraception May 2024The Adherence with Continuous Dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) study assessed whether consumers can adhere to the regimen for a...
OBJECTIVE
The Adherence with Continuous Dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) study assessed whether consumers can adhere to the regimen for a progestin-only pill (norgestrel 0.075 mg) in an over-the-counter (OTC) setting.
STUDY DESIGN
An actual use study in a simulated OTC environment assessed adherence to directions to take norgestrel 0.075 mg every day at the same time in 883 participants for up to 24 weeks.
RESULTS
Eighty-five percent (747/883) of participants reported ≥85% adherence to taking norgestrel 0.075 mg every day and reported taking their dose within three hours of their scheduled dosing time on 96% of days. When accounting for use of a condom for 48 hours if a pill was missed, participants reported correctly following the label's directed use for 97% of doses overall, with 95% of participants following label directions for ≥85% of doses. The main limitations were related to finding a balance between intensely collecting data to ensure accurate assessment of adherence and leaving users to behave as they would in a real OTC situation without healthcare practitioner intervention. We observed that some participants reported taking more doses than they could have based on the supply of medication given to them. To fully examine the situation, and the impact on the conclusions, additional post hoc sensitivity analyses were performed, and showed remarkably consistent results.
CONCLUSIONS
Consumers were highly adherent to taking norgestrel 0.075 mg when using only the information provided by the proposed OTC label.
IMPLICATIONS
Adherence to a daily oral contraceptive pill was high when obtained OTC. This suggests that effectiveness of an OTC pill is likely to be like that of a prescribed pill and easier access to this effective contraceptive should allow more opportunity to prevent pregnancy.
Topics: Pregnancy; Female; Humans; Progestins; Norgestrel; Contraception; Contraceptive Devices; Nonprescription Drugs; Contraceptives, Oral
PubMed: 38431261
DOI: 10.1016/j.contraception.2024.110388 -
BMC Public Health Mar 2024Ethiopia has made considerable progress toward measles elimination. Despite ongoing efforts, the country remains among those with the highest number of children missing...
BACKGROUND
Ethiopia has made considerable progress toward measles elimination. Despite ongoing efforts, the country remains among those with the highest number of children missing their initial dose of measles vaccine, and the disease continues to be a public health emergency. The barriers within the health system that hinder the first dose of measles immunization have not been thoroughly investigated. This study aims to identify these barriers within the Ethiopian context.
METHODS
Qualitative research, using purposive expert sampling to select key informants from health organizations in Addis Ababa, Ethiopia was employed. We conducted in-depth face-to-face interviews using a semi-structured interview guide. A thematic analysis based on the World Health Organization's health systems building blocks framework was conducted.
RESULTS
The study uncovered substantial health system barriers to the uptake of the first dose of the measles vaccine in Ethiopia. These barriers include; restricted availability of immunization services, vaccine stockouts, shortage of cold chain technologies, data inaccuracy resulting from deliberate data falsification or accidental manipulation of data, as well as data incompleteness.
CONCLUSION
Our research highlighted significant health system barriers to MCV immunization, contributing to unmet EPI targets in Ethiopia. Our results suggest that to accelerate the country towards measles elimination, there is an urgent need to improve the health systems components such as service delivery, information systems, as well as access to vaccine and cold chain technologies.
Topics: Child; Humans; Ethiopia; Vaccination; Measles; Measles Vaccine; Immunization; Qualitative Research; Immunization Programs
PubMed: 38429806
DOI: 10.1186/s12889-024-18132-6 -
Trials Feb 2024The ProMPT-2 trial (Propofol for Myocardial Protection Trial #2) aims to compare the safety and efficacy of low- and high-dose propofol supplementation of the...
Efficacy of propofol-supplemented cardioplegia on biomarkers of organ injury in patients having cardiac surgery using cardiopulmonary bypass: a statistical analysis plan for the ProMPT-2 randomised controlled trial.
BACKGROUND
The ProMPT-2 trial (Propofol for Myocardial Protection Trial #2) aims to compare the safety and efficacy of low- and high-dose propofol supplementation of the cardioplegia solution during adult cardiac surgery versus sham supplementation. This update presents the statistical analysis plan, detailing how the trial data will be analysed and presented. Outlined analyses are in line with the Consolidated Standards of Reporting Trials and the statistical analysis plan has been written prior to database lock and the final analysis of trial data to avoid reporting bias (following recommendations from the International Conference on Harmonisation of Good Clinical Practice).
METHODS/DESIGN
ProMPT-2 is a multi-centre, blinded, parallel three-group randomised controlled trial aiming to recruit 240 participants from UK cardiac surgery centres to either sham cardioplegia supplementation, low dose (6 µg/ml) or high dose (12 µg/ml) propofol cardioplegia supplementation. The primary outcome is cardiac-specific troponin T levels (a biomarker of cardiac injury) measured during the first 48 h following surgery. The statistical analysis plan describes the planned analyses of the trial primary and secondary outcomes in detail, including approaches to deal with missing data, multiple testing, violation of model assumptions, withdrawals from the trial, non-adherence with the treatment and other protocol deviations. It also outlines the planned sensitivity analyses and exploratory analyses to be performed.
DISCUSSION
This manuscript prospectively describes, prior to the completion of data collection and database lock, the analyses to be undertaken for the ProMPT-2 trial to reduce risk of reporting and data-driven analyses.
TRIAL REGISTRATION
ISRCTN ISRCTN15255199. Registered on 26 March 2019.
Topics: Adult; Humans; Biomarkers; Cardiac Surgical Procedures; Cardiopulmonary Bypass; Heart Arrest, Induced; Multicenter Studies as Topic; Propofol; Randomized Controlled Trials as Topic; Treatment Outcome; Troponin T
PubMed: 38424570
DOI: 10.1186/s13063-024-08016-w -
Vaccine Mar 2024COVID-19 seriously impacted routine immunization (RI) in Iraq. Coverage declined to a 6-year low in 2021, and COVID-19 vaccination uptake was slow. In response,...
INTRODUCTION
COVID-19 seriously impacted routine immunization (RI) in Iraq. Coverage declined to a 6-year low in 2021, and COVID-19 vaccination uptake was slow. In response, government implemented intensification of integrated immunization services (3IS), a nationwide approach comprising regular outreach sessions of COVID-19 vaccination and RI for children who had either missed doses or never commenced scheduled vaccination (zero-dose children). We describe the 3IS and its impact on vaccination coverage in Iraq.
METHODS
3IS comprised new outreach sessions for urban and rural communities where administrative data suggested there were gaps in coverage. Groups of six personnel from each of 1,321 primary healthcare centres implemented six outreach sessions per month during February-November 2022. Community engagement was an integral component. We compared RI administrative data (2019-2022) and data reported during 3IS activities to assess its impact.
RESULTS
In total 4,189,859 vaccine doses were administered during 72,495 3IS outreach sessions, over one-fifth of 19,106,849 vaccine doses administered in Iraq over these 10 months. Among them, 957,874 (22.9 %) were COVID-19 vaccines, adding slightly to national coverage, and 3,231,985 (77.1 %) were RI vaccines, dramatically reducing zero-dose children, adding 18 %, 25 %, 21 %, and 31 % to 2022 penta1, penta3, measles first-dose and MMR1 vaccine coverage, and contributing to national coverage of 102.2 %, 94.5 %, 91.8 % and 96.3 % for these vaccines during February-November, respectively. Moreover, 3IS sessions delivered 133,528 doses of tetanus toxoid, 16,353 doses of adult HepB vaccine, and 315,032 vitamin A doses to eligible individuals.
CONCLUSION
In the context of global encouragement to integrate vaccination services, Iraq's 3IS approach enabled dramatic improvements in RI coverage, virtual elimination of zero-dose status among children born during the pandemic, and small improvements in COVID-19 and adult vaccination. Our findings provide lessons for future integrated primary care towards universal health coverage in Iraq, and for other countries yet to undertake integration.
Topics: Child; Adult; Humans; Infant; COVID-19 Vaccines; Vaccination Coverage; Iraq; COVID-19; Vaccination; Immunization; Immunization Programs; Tetanus Toxoid
PubMed: 38418341
DOI: 10.1016/j.vaccine.2024.02.038 -
PLOS Global Public Health 2024Adolescents account for an estimated 800,000 incident tuberculosis (TB) cases annually and are at risk for suboptimal adherence to TB treatment. Most studies of...
Adolescents account for an estimated 800,000 incident tuberculosis (TB) cases annually and are at risk for suboptimal adherence to TB treatment. Most studies of adolescent TB treatment adherence have used surveillance data with limited psychosocial information. This prospective cohort study aimed to identify risk factors for suboptimal adherence to rifampicin-susceptible TB treatment among adolescents (10-19 years old) in Lima, Peru. We collected psychosocial data using self-administered surveys and clinical data via medical record abstraction. Applying k-means cluster analysis, we grouped participants by psychosocial characteristics hypothesized to impact adherence. Then, we conducted mixed effects regression to compare suboptimal adherence-defined as <90% (missing >10% of doses)-between clusters. Treatment setting (facility vs. home) and drug formulation (single drug vs. fixed dose combination) were interaction terms. Of 249 participants, 90 (36.1%) were female. Median age was 17 (IQR: 15, 16.6) years. We identified three clusters-A, B, and C-of participants based on psychosocial characteristics. Cluster C had the lowest support from caregivers, other family members, and friends; had the weakest motivation to complete TB treatment; were least likely to live with their mothers; and had experienced the most childhood adversity. Among the 118 (47.4%) participants who received facility-based treatment with single drug formulations, adherence did not differ between Clusters A and B, but Cluster C had six-fold odds of suboptimal adherence compared to Cluster A. In Clusters B and C, adherence worsened over time, but only in Cluster C did mean adherence fall below 90% within six months. Our findings have implications for the care of adolescents with TB. When caring for adolescents with low social support and other risk factors, clinicians should take extra measures to reinforce adherence, such as identifying a community health worker or peer to provide treatment support. Implementing newly recommended shorter regimens also may facilitate adherence.
PubMed: 38412160
DOI: 10.1371/journal.pgph.0002918 -
Vaccines Feb 2024Zero-dose (ZD) children is a critical objective in global health, and it is at the heart of the Immunization Agenda 2030 (IA2030) strategy. Coverage for the first dose...
Zero-dose (ZD) children is a critical objective in global health, and it is at the heart of the Immunization Agenda 2030 (IA2030) strategy. Coverage for the first dose of diphtheria-tetanus-pertussis (DTP1)-containing vaccine is the global operational indicator used to estimate ZD children. When surveys are used, DTP1 coverage estimates usually rely on information reported from caregivers of children aged 12-23 months. It is important to have a global definition of ZD children, but learning and operational needs at a country level may require different ZD measurement approaches. This article summarizes a recent workshop discussion on ZD measurement for targeted surveys at local levels related to flexibilities in age cohorts of inclusion from the ZD learning Hub (ZDLH) initiative-a learning initiative involving 5 consortia of 14 different organizations across 4 countries-Bangladesh, Mali, Nigeria, and Uganda-and a global learning partner. Those considerations may include the need to generate insights on immunization timeliness and on catch-up activities, made particularly relevant in the post-pandemic context; the need to compare results across different age cohort years to better identify systematically missed communities and validate programmatic priorities, and also generate insights on changes under dynamic contexts such as the introduction of a new ZD intervention or for recovering from the impact of health system shocks. Some practical considerations such as the potential need for a larger sample size when including comparisons across multiple cohort years but a potential reduction in the need for household visits to find eligible children, an increase in recall bias when older age groups are included and a reduction in recall bias for the first year of life, and a potential reduction in sample size needs and time needed to detect impact when the first year of life is included. Finally, the inclusion of the first year of life cohort in the survey may be particularly relevant and improve the utility of evidence for decision-making and enable its use in rapid learning cycles, as insights will be generated for the population being currently targeted by the program. For some of those reasons, the ZDLH initiative decided to align on a recommendation to include the age cohort from 18 weeks to 23 months, with enough power to enable disaggregation of key results across the two different cohort years. We argue that flexibilities with the age cohort for inclusion in targeted surveys at the local level may be an important principle to be considered. More research is needed to better understand in which contexts improvements in timeliness of DTP1 in the first year of life will translate to improvements in ZD results in the age cohort of 12-23 months as defined by the global DTP1 indicator.
PubMed: 38400178
DOI: 10.3390/vaccines12020195