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Keywords | PMC10403908 | |||
Introduction | IBD | Maternal mortality statistics in developing nations, particularly in Sub-Saharan Africa (SSA), are alarming. The Maternal Mortality Ratio (MMR) in SSA is estimated to be 545/100,000 live births [Many variables influence maternal health care utilization, including negative socio-cultural issues [The current maternal hea... | PMC10403908 | |
Methods | PMC10403908 | |||
Study design and population | The effects of the intervention on maternal health choices and outcomes among young married women were evaluated using a randomized controlled assessment approach with cross-sectional pre-post surveys in experimental and control areas. The study population consisted of young married pregnant women. The same pregnant wo... | PMC10403908 | ||
Study setting | WEST | The study was conducted in the Sissala East and Sissala West Districts of the Upper West Region, Ghana. The districts were initially one district until 2004 when it was split into Sissala East and Sissala West for effective decentralization by the government. They are largely rural settings located in the eastern part ... | PMC10403908 | |
Program design | WEST | The project ‘Strengthening the knowledge of women in the community through health education on the importance and utilization of maternal health services (ANC, facility delivery, and PNC)’ was implemented by community-based Maternal Health Agents (COMHAs) and midwives from June 2019-July, 2020. It was to improve the ut... | PMC10403908 | |
Sampling method | WEST | There were two and three poor-performing subdistricts (in terms of maternal health indicators) in the Sissala East and Sissala West Districts, respectively. Two subdistricts (one from each district) with similar characteristics were randomly selected out of the five sub-districts. The selected subdistrict (Sakai) of th... | PMC10403908 | |
Inclusion and exclusion criteria | death, abortion | Only postpartum women who had been residents for 12 months of the study and had participated in the intervention from 3 to 12 months in the study area were interviewed. Women who resided in the study subdistricts and had received the intervention throughout the period but might have received ANC, skilled delivery, and ... | PMC10403908 | |
Study instrument | At baseline, a pretested structured interviewer-administered paper questionnaire, designed in the English language, was used to collect data from participating mothers. At the end line, the same structured questionnaire was used in Open Data Kit and uploaded to mobile phones for data collection; a password-protected cl... | PMC10403908 | ||
Study variables | This section presents a comprehensive list of both dependent and independent variables utilized in the study, along with their corresponding levels of measurement and variable types. The dependent variable, “Health education intervention”, was a nominal categorical variable with two distinct categories, “Exposed” and “... | PMC10403908 | ||
Statistical analysis | IBD | Sample characteristics for women visiting ANC and PNC, as well as those who delivered their babies in health care facilities, were examined using descriptive statistics (means and percentages). At the descriptive analysis level; frequencies, percentages, means, maximums, and minimums were calculated. These statistics p... | PMC10403908 | |
Operational definitions | Knowledge of skilled maternal health services was defined such that women who scored above the mean of knowledge assessment questions were categorized as having good knowledge, and if they scored below the mean, they were considered as having poor knowledge [The attitude was measured by using the Likert scale (1 = stro... | PMC10403908 | ||
Ethical consideration | CHRPE | WEST | The Kwame Nkrumah University of Science and Technology School of Medical Sciences Committee on Human Research Publication and Ethics (CHRPE) approved the study (CHRPE/AP/190/19). Formal administrative permission was obtained from the Upper West Regional Health Directorate and the Sissala East and Sissala West District ... | PMC10403908 |
Results | PMC10403908 | |||
Socio-demographic profile of respondents | Overall, 524 women were interviewed at baseline. This comprised 264 pregnant women sampled in the intervention group, and 260 pregnant women sampled in the control group. At the endline, 492 postpartum women were interviewed, which comprised 250 and 242 women from the control and intervention groups. Women surveyed at ... | PMC10403908 | ||
Pre-and post-assessment of women’s knowledge of, and practices related to the utilization of antenatal care, skilled delivery, and postnatal care | The bivariate analysis (Pearson Chi-square test) showed that at baseline, the outcomes were different between the two groups (control and intervention), differed significantly in terms of ANC attendance (p < 0.0001), place of delivery (p = 0.001), and PNC attendance (p < 0.0001).At post-intervention, there were improve... | PMC10403908 | ||
Percentage of women who knew about obstetric danger signs at baseline and end line in the control and intervention arms | The end-line data showed that women who received the health education intervention from Community Maternal Health Agents and midwives about obstetric danger signs had improved knowledge by 50% at the endline compared to women who did not receive the health education (Fig.
Percentage of women who were knowledgeable on ... | PMC10403908 | ||
Effect of a health education intervention to improve knowledge of pregnant women on danger signs, complications, and birth preparedness plan readiness | COMPLICATIONS, COMPLICATION | At post-intervention, women who had received the health education intervention (intervention arm) were significantly more likely to have good knowledge on danger signs when compared with women who did not receive a health education intervention (control arm) (AOR = 10.17; [95%CI = 6.59–15.69]; p = 0.0001). Those women ... | PMC10403908 | |
Covariate adjusted simple logistic regression of factors that influenced the utilization of antenatal care, skilled delivery, and postnatal care services | REGRESSION, WEST, SECONDARY | A covariates adjusted simple logistic regression model was used to determine the factors that influenced the utilization of antenatal care, skilled delivery, and postnatal care services after the community-based intervention. The results show that age at first marriage, education status, distance to a health facility, ... | PMC10403908 | |
Effect of a health education intervention on pregnant women’s attitudes towards, and practices related to the use of ANC and skilled delivery services | At post-intervention, women who received the health education intervention on skilled delivery were 3 times more likely to have a positive attitude towards skilled delivery compared to women who did not receive the health education intervention on skilled delivery (AOR = 3.34; 95%CI: 2.12–5.25; p = 0.001). Moreover, at... | PMC10403908 | ||
Impact of community participation and stakeholder engagement to improve community support to enhance maternal health outcomes | In the intervention area, 83.5% of women made four or more antenatal care visits during their last pregnancy at baseline and its uptake significantly increased to 90.0% (Diff-in-diff=-3.2; t = 29.69; p < 0.0001) at the end line. The Difference-In-Difference (DID) analysis revealed a net improvement of 6.5% in the inter... | PMC10403908 | ||
Discussion | COMPLICATIONS, PREGNANCY COMPLICATIONS | The main issue that this study tried to answer was whether community-level social and behavioral change, interaction with Maternal Health Promoters or Agents and community involvement had an effect on the use of maternal health care. Additionally, if there were any differences between the research arms that were the co... | PMC10403908 | |
Limitations and strengths of the study | EVENTS | The findings from this study provide important considerations for advocacy. There was a likelihood of recall bias since the study required the women to recall previous events. The COVID-19 pandemic has also impacted the research; the study sought to use focus group discussions and pregnancy classes to educate mothers. ... | PMC10403908 | |
Conclusion | To increase pregnant women’s awareness of and use of maternal healthcare services, the community-based integrated intervention method can be beneficial. In northern Ghana, the maternity care results and women’s household decision-making behavior had a decreased correlation. However, engaging pregnant mothers and family... | PMC10403908 | ||
Acknowledgements | The authors would like to thank the KNUST School of Public Health, the healthcare service providers, community leaders, project teams, and study participants. | PMC10403908 | ||
Authors’ contributions | Dormechele | Alex Bapula Kassim was the principal researcher and contributed to proposal development, pretesting of the questionnaires, supervising the data collectors, data entry, and the writing of the manuscript. William Dormechele contributed to data cleaning, data analysis, and manuscript preparation. Beatrice Baah Rahinatu an... | PMC10403908 | |
Funding | The authors received no specific funding for this work. | PMC10403908 | ||
Data Availability | All data generated or analysed during this study are included in this published article as supplementary file | PMC10403908 | ||
Declarations | PMC10403908 | |||
Ethics approval and consent to participate | Ethical clearance was obtained from the Kwame Nkrumah University of Science and Technology School of Committee on Human Research Publication and Ethics, Ghana (Clearance Number: CHRPE/AP/190/19). Interviewers explained to the participants the contents of a written consent form, including their right to withdraw from pa... | PMC10403908 | ||
Consent for publication | Not applicable. | PMC10403908 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10403908 | ||
Abbreviations | Birth RateInstitutional-Based | COMPLICATION | Antenatal CareAdjusted Odds RatioBirth Preparedness and Complication ReadinessConfidence IntervalCommittee on Human Research Publication and EthicsCommunity Health OfficerCommunity-Based Health Planning and ServicesCommunity-based Maternal Health AgentsCrude Odds RatioCrude Birth RateInstitutional-Based DeliveryMaterna... | PMC10403908 |
References | PMC10403908 | |||
Aim | Edited by: Gudrun Stenbeck, Brunel University London, United KingdomReviewed by: Shihai Jia, The University of Utah, United States; Elena Canciani, University of Eastern Piedmont, Italy‡ORCID: Junbo Tu, †These authors have contributed equally to this work and share first authorshipThe aim of this clinical trial was to ... | PMC10231034 | ||
Materials and methods | A total of 60 sides of 30 participants who had completely symmetrical bilateral impacted lower third molars were enrolled. The primary outcome variables of the study were bone height and width, bone density, and socket surface area in the coronal section. Cone beam computed tomography images were obtained immediately a... | PMC10231034 | ||
Results | ± | CGF sites had higher values in height and width when compared to control sites (Buccal wall 32.9 ± 3.5 vs 29.4 ± 4.3 mm, Lingual wall 25.4 ± 3.5 vs 23.1 ± 4 mm, and Alveolar bone width 21.07 ± 1.55vs19.53 ± 1.90 mm, respectively). Bone density showed significantly higher values in CGF sites than in control sites (Coron... | PMC10231034 | |
Conclusion | CGF application following surgical extraction provides an easy, low-cost, and efficient option for alveolar ridge preservation. Thus, the use of CGF by dentists during dental extractions may be encouraged, particularly when alveolar ridge preservation is required. | PMC10231034 | ||
Clinical trial registration | TCTR | TCTR identification, TCTR20221028003. | PMC10231034 | |
Introduction | loss of alveolar bone | One of the most critical competencies in advanced dentistry is alveolar ridge preservation (ARP) after exodontia. The loss of alveolar bone may be attributed to a variety of factors (The mechanism of extraction socket healing is characterized by internal changes that result in the formation of the bone inside the socke... | PMC10231034 | |
Material and methods | TCTR | SAND IMPACTION | This prospective, split-mouth, randomized, single-blind, clinical study was conducted in accordance with the Helsinki Declaration at the outpatient clinic department of oral surgery-hospital of Stomatology, Xian Jiaotong University from 25 June 2022 to 20 October 2022. This trial protocol was reviewed and approved by t... | PMC10231034 |
Sample size calculation | The sample size was determined using the G*power 3.0.10 software. The required minimum sample size was 24 subjects for each group. This demonstrated that a target significance value of 0.05 would need a sample size of 30 subjects (30 test sides and 30 control sides) to have 85% power to detect a statistical difference ... | PMC10231034 | ||
CGF preparation | Fresh venous blood | Fresh venous blood from patients was used to collect autologous CGF samples. They were divided into two clean 10 ml tubes without adding any anticoagulants, and they were centrifuged immediately (Preparation of CGF. | PMC10231034 | |
Randomization | An opaque, sealed envelope ( | PMC10231034 | ||
Study variables | SECONDARY | The application of CGF is regarded as the study’s main variable.The primary outcome variables of the study were bone height and width, bone density, and socket surface area.The secondary outcome variable was the periodontal pocket of the second molars. | PMC10231034 | |
Surgical procedure | tooth separation | BLOOD | The same surgical protocol as in our previous study (Each patient had a radiologic examination, including a panoramic radiograph before surgery (Blood was collected from patients.Patients gargled with 0.12% chlorhexidine gluconate as an antiseptic mouthwash for one minute.The root surfaces of lower second molars were s... | PMC10231034 |
Clinical features assessment | The assessment of the periodontal pockets of the second molars was done before surgical extraction and after 3 months using the UNC-15 periodontal probe ( | PMC10231034 | ||
Radiographic features assessment | CREST | A cone beam computed tomography (CBCT) was taken immediately after extraction (C1), followed by a CBCT three months later (C2) as a temporal measure (Measurements methodology Buccal and lingual alveolar bone heights were measured as the vertical distances between the horizontal tangent line of the lower border of the m... | PMC10231034 | |
Data analysis | The Statistical Package for Social Sciences (SPSS) version 25 (Chicago, USA) was used to compute descriptive and analytical statistics. Paired | PMC10231034 | ||
Results | In this clinical trial, 30 patients (16 men and 14 women) with an average age of 25 years had surgical extraction of both of their impacted lower third molars in a single visit at the outpatient clinic department of oral surgery-Hospital of Stomatology, Xian Jiaotong University. We used the lower third molar region as ... | PMC10231034 | ||
Discussion | osseous defect, tooth | The 1980s saw the introduction of bone grafts in fresh sockets for ARP (Thus, novel bio-active methods have been devised to counteract the limitations of previous bone graft substances. Autogenous growth factors are mostly derived from platelets. Growth factors such as PRP, PRF, and CGF are bioactive proteins that regu... | PMC10231034 | |
Conclusion | Extracted sockets grafted with CGF showed a good and successful outcome with regard to alveolar ridge preservation. CGF application following surgical extraction provides an easy, low-cost, and efficient option for alveolar preservation, considering its biocompatibility, resilience, and availability. Thus, the use of C... | PMC10231034 | ||
Data availability statement | The original contributions presented in the study are included in the article/ | PMC10231034 | ||
Ethics statement | The study protocol was reviewed and approved by the institutional ethics committee at the Hospital of Stomatology, Xian Jiaotong University, Xian, China. The patients/participants provided their written informed consent to participate in this study. | PMC10231034 | ||
Author contributions | SE, HY | SE, HY, and HC contributed to data collection, interpretation of data, designing the study, and writing the original manuscript. All other authors have critically revised the manuscript and have approved the final manuscript prior to its submission. | PMC10231034 | |
Acknowledgments | The authors would like to thank Dr.Yao Jie, Dr.Omar Al-aromy, Dr.Bassam Abo-Taleb, Dr.Mubarak Mashrah, and Dr.Nawaf Al-Mekhlafy for their consultations and assistance in accomplishing this study. | PMC10231034 | ||
Abbreviations | CGF, Concentrated growth factors; PRF, Platelet rich fibrin; PRP, Platelet rich plasma; ARP, alveolar ridge preservation; C1, a cone beam computed tomography taken immediately after extraction; C2, a cone beam computed tomography taken after three months. | PMC10231034 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10231034 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC10231034 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file.Click here for additional data file.Click here for additional data file. | PMC10231034 | ||
References | PMC10231034 | |||
Background: | RELAPSING MULTIPLE SCLEROSIS | Ofatumumab has demonstrated superior efficacy and favorable safety for up to 2.5 years versus teriflunomide in relapsing multiple sclerosis (RMS). | PMC10580679 | |
Objective: | Further characterize efficacy and safety of ofatumumab in RMS. | PMC10580679 | ||
Methods: | Efficacy set: patients randomized to ofatumumab/teriflunomide in ASCLEPIOS I/II (core). Safety set: patients who received ⩾ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS (all core), or ALITHIOS (umbrella open-label extension). Patients received continuous ofatumumab or were newly switched from teriflunomide.... | PMC10580679 | ||
Results: | In the efficacy set ( | PMC10580679 | ||
Conclusion: | Ofatumumab has a favorable longer-term benefit–risk profile in RMS. | PMC10580679 | ||
Trial registry: | ALITHIOS (NCT03650114): | PMC10580679 | ||
Introduction | RELAPSING MULTIPLE SCLEROSIS | Ofatumumab is a fully human, anti-CD20 monoclonal antibody (mAb) approved for relapsing multiple sclerosis (RMS) in many countries.Ofatumumab approval was based on the ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) Phase 3 studies, which demonstrated superior efficacy versus teriflunomide and a favorable bene... | PMC10580679 | |
Patients and methods | PMC10580679 | |||
Trial design and patients | The methods of ASCLEPIOS I/II, APLIOS, and APOLITOS have been reported previously.Analysis sets and time periods.*The “newly switched ofatumumab group” comprised patients randomized to teriflunomide in ASCLEPIOS I/II (those who completed treatment were eligible to enter ALITHIOS and be switched to ofatumumab); the “con... | PMC10580679 | ||
Analysis populations | PMC10580679 | |||
Efficacy analysis set | death | DISEASE | Efficacy analyses consisted of data from patients randomized to ofatumumab or teriflunomide in ASCLEPIOS I/II. For three-parameter no evidence of disease activity (NEDA-3), a modified efficacy analysis set was used, excluding patients who discontinued treatment early except due to lack of efficacy or death and had NEDA... | PMC10580679 |
Safety analysis set | Safety analyses consisted of data from patients who received ⩾ 1 dose of ofatumumab in ASCLEPIOS I/II, APLIOS, APOLITOS, or ALITHIOS (see | PMC10580679 | ||
Analysis of delayed versus early initiation of ofatumumab | Two analysis subgroups were defined: the “continuous ofatumumab group” and the “newly switched ofatumumab group” (see | PMC10580679 | ||
Efficacy endpoints | disability | EVENTS | The endpoints assessed were: ARR; confirmed disability worsening (CDW) events (increase from baseline Expanded Disability Status Scale score sustained for ⩾ 3/6 months (3/6mCDW) mean number of gadolinium-enhancing (Gd+) T1 lesions per scan; number of new/enlarging T2 (neT2) lesions per year; serum neurofilament light c... | PMC10580679 |
Safety and tolerability evaluation | ADVERSE EVENT | AEs were graded according to the Common Terminology Criteria for Adverse Events version 5.0, | PMC10580679 | |
Statistical analyses | efficacy/death | REGRESSION | The ARR for the newly switched and continuous ofatumumab groups was estimated using a piecewise negative binomial model. Cumulative 3/6mCDW were assessed using Kaplan–Meier curves. Lesions per scan and adjusted annualized rates of lesions were estimated using piecewise negative binomial models. Between-group comparison... | PMC10580679 |
Results | PMC10580679 | |||
Patients | PMC10580679 | |||
Efficacy subgroups: baseline demographics and reasons for discontinuation | multiple sclerosis disease, RRMS | RELAPSING REMITTING MULTIPLE SCLEROSIS, MULTIPLE SCLEROSIS, SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS | The efficacy analysis set included 1882 patients: in ASCLEPIOS I/II, 936 and 946 patients were randomized to teriflunomide and ofatumumab, respectively; 72.6% (Baseline demographics and clinical characteristics (efficacy analysis setBMI: body mass index; EDSS: Expanded Disability Status Scale; Gd+: gadolinium-enhancing... | PMC10580679 |
Safety analyses | The safety analysis set included 1969 patients (see | PMC10580679 | ||
Clinical efficacy assessments | PMC10580679 | |||
Relapses | RELAPSE | The continuous ofatumumab group maintained a low ARR for up to 4 years: adjusted ARRs in the core and extension periods were 0.11 (95% confidence interval (CI): 0.08–0.13) and 0.05 (95% CI: 0.04–0.07), respectively (49.4%; Relapse data: (a) within-group comparison of ARR during the core and open-label extension periods... | PMC10580679 | |
MRI assessments | Near-complete suppression of MRI activity was maintained through 4 years in the continuous ofatumumab group. The adjusted mean number of Gd+ T1 lesions per scan in the core and extension periods was: 0.02 (95% CI: 0.02–0.03) and 0.01 (95% CI: 0.00–0.02), respectively; a reduction of 65.0% (Lesion activity on MRI in the... | PMC10580679 | ||
sNfL concentration | In the core period, sNfL concentration was lower with ofatumumab versus teriflunomide (concentration at Month 12: 8.03 versus 10.25 pg/mL; at Month 24: 7.96 versus 9.97 pg/mL, respectively; both | PMC10580679 | ||
Safety | PMC10580679 | |||
AE profile | death, sudden death | SUDDEN DEATH, ADVERSE EVENT | Safety was consistent with previous reportsSafety summary (safety analysis set).AE: adverse event; CI: confidence interval; EAIR: exposure adjusted incidence rate per 100 patient years; SAE: serious adverse event.Preferred terms are according to MedDRA version 24.1.Data from the safety analysis set.Data are from the co... | PMC10580679 |
Serious infections | infections | INFECTIONS | The EAIR of serious infections remained stable (overall safety analysis set ( | PMC10580679 |
Immunoglobin G and immunoglobin M | Mean serum immunoglobin G (IgG) levels remained stable and above the lower limit of normal (LLN; 5.65 g/L), even in patients with lower IgG levels at baseline (see | PMC10580679 | ||
Neutropenia and lymphopenia | Mean lymphocyte and neutrophil levels remained stable and were above the LLN; any reductions below the LLN occurred randomly and were not persistent (see | PMC10580679 | ||
Injection-related reactions | Of 1969 patients, 487 (24.7%) and 233 (11.8%) experienced a systemic and injection site-related reaction, respectively. Most systemic and injection site-related reactions (IRRs) were Grade 1/2 ( | PMC10580679 | ||
Malignancies | malignancies | MALIGNANCIES | The incidence of malignancies was low (overall safety analysis set: 0.86%; EAIR 0.33 (95% CI: 0.20–0.53), see | PMC10580679 |
Deaths | deaths | In total, 6/1969 deaths occurred during the extension period and were reported by investigators as unrelated to ofatumumab (see | PMC10580679 | |
Discussion | infection, neuroaxonal injury, disability, reduction of | REGRESSION, EVENTS, INFECTION | This interim analysis provides new insights into the longer-term efficacy and safety of ofatumumab in RMS, supporting a favorable benefit–risk profile. The low rate of relapses with ofatumumab, as identified in ASCLEPIOS I/II,Early initiation of high-efficacy treatment for RMS improves longer-term outcomes compared wit... | PMC10580679 |
Supplemental Material | PMC10580679 | |||
References | PMC10580679 | |||
Abstract | PMC10281637 | |||
Introduction | Assisted partner notification (APN) safely and effectively increases partner awareness of HIV exposure, testing and case identification in community settings. Nonetheless, it has not been specifically developed or evaluated for use in prison settings where people with HIV often are diagnosed and may have difficulty con... | PMC10281637 | ||
Methods | From January 2020 to January 2021, 55 incarcerated men with HIV were recruited as index participants from six jail and prison facilities in Jakarta in a two‐group randomized trial comparing the outcomes of self‐tell notification (treatment as usual) versus Impart APN in increasing partner notification and HIV testing. ... | PMC10281637 | ||
Results | Index participants ( | PMC10281637 |
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