title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Findings | ONCOLOGY, SECONDARY | In this secondary analysis of 3 NRG Oncology randomized clinical trials, prolonged RT duration was associated with inferior disease-free survival. Female patients and those with other (vs White) race and ethnicity were more likely to have prolonged RT duration and to experience RT interruptions. | PMC10122174 | |
Meaning | Findings of this study suggest that RT interruptions should be minimized to optimize outcomes. | PMC10122174 | ||
Importance | epithelial malignant neoplasms | ADVERSE EFFECT | For many types of epithelial malignant neoplasms that are treated with definitive radiotherapy (RT), treatment prolongation and interruptions have an adverse effect on outcomes. | PMC10122174 |
Objective | esophageal cancer | OESOPHAGEAL CANCER | To analyze the association between RT duration and outcomes in patients with esophageal cancer who were treated with definitive chemoradiotherapy (CRT). | PMC10122174 |
Design, Setting, and Participants | nonmetastatic esophageal cancer, Cancer | ONCOLOGY, SECONDARY, BREAST, CANCER | This study was an unplanned, post hoc secondary analysis of 3 prospective, multi-institutional phase 3 randomized clinical trials (Radiation Therapy Oncology Group [RTOG] 8501, RTOG 9405, and RTOG 0436) of the National Cancer Institute–sponsored NRG Oncology (formerly the National Surgical Adjuvant Breast and Bowel Pro... | PMC10122174 |
Exposures | Treatment groups in the trials used standard-dose RT (50 Gy) and concurrent chemotherapy. | PMC10122174 | ||
Main Outcomes and Measures | local-regional failure | The outcomes were local-regional failure (LRF), distant failure, disease-free survival (DFS), and overall survival (OS). Multivariable models were used to examine the associations between these outcomes and both RT duration and interruptions. Radiotherapy duration was analyzed as a dichotomized variable using an X-Tile... | PMC10122174 | |
Results | The analysis included 509 patients (median [IQR] age, 64 [57-70] years; 418 males [82%]; and 376 White individuals [74%]). The median (IQR) follow-up was 4.01 (2.93-4.92) years for surviving patients. The median cut point of RT duration was 39 days or less in 271 patients (53%) vs more than 39 days in 238 patients (47%... | PMC10122174 | ||
Conclusions and Relevance | esophageal cancer | OESOPHAGEAL CANCER | Results of this study indicated that in patients with esophageal cancer receiving definitive CRT, prolonged RT duration was associated with inferior outcomes; female patients and those with other (vs White) race and ethnicity were more likely to have longer RT duration and experience RT interruptions. Radiotherapy inte... | PMC10122174 |
Introduction | esophageal cancer, head and neck, lung, cervical, and anal cancer, Treatment-related, epithelial malignant neoplasms, inferior tumor | ESOPHAGEAL CANCER, OESOPHAGEAL CANCER | Radiotherapy (RT) and chemoradiotherapy (CRT) are used for the curative treatment of many epithelial malignant neoplasms. Treatment-related toxic effects may lead to treatment interruptions and prolonged treatment duration. In the curative treatment of head and neck, lung, cervical, and anal cancer with RT and/or CRT, ... | PMC10122174 |
Methods | PMC10122174 | |||
Patient Cohorts and Treatment | nonmetastatic esophageal cancer | SECONDARY | This unplanned, post hoc secondary analysis included evaluable patients with nonmetastatic esophageal cancer who underwent definitive CRT in the RTOG 8501, RTOG 9405 ( | PMC10122174 |
Study Flow Diagram | ONCOLOGY | RT indicates radiation therapy; RTOG, Radiation Therapy Oncology Group.RTOG 8501, which was conducted between January 1986 and April 1990 and predated ClinicalTrials.gov, was a prospective, multi-institutional randomized phase 3 trial that compared high-dose RT alone with CRT.RTOG 9405, which was conducted between June... | PMC10122174 | |
RT Duration and RT Interruptions | Radiotherapy duration was defined as the interval from the date of the first fraction of RT to the date of the last fraction of RT. Radiotherapy duration was analyzed as a dichotomized variable using its median value as a cut point, using X-Tile software (Yale School of Medicine) to choose a cut-point value, and as a c... | PMC10122174 | ||
Outcomes Assessed | local-regional failure, death, Regional failure | CELIAC, DISEASE PROGRESSION, RECURRENCE, DISEASE, PRIMARY TUMOR | Outcomes assessed included local-regional failure (LRF), distant failure (DF), DFS, and overall survival (OS). Local failure was defined as disease recurrence or progression in the primary tumor. Patients who never had a local clearance were considered to have failure at day 1. Regional failure was defined as a recurre... | PMC10122174 |
Statistical Analysis | squamous cell vs, weight loss | ONCOLOGY, ADENOCARCINOMA, PRIMARY TUMOR | All data analyses were performed between March 2022 and February 2023 using SAS, version 9.4 (SAS Institute Inc). A 2-sided Local-regional failure and DF were estimated in the univariable analysis using the cumulative incidence method, and dichotomized RT duration and RT interruptions were compared using the Gray test.... | PMC10122174 |
Results | The cohort included 509 patients, of whom 117 evaluable patients were from the RTOG 8501 trial, 105 evaluable patients were from the RTOG 9405 trial, and 287 evaluable patients were from the RTOG 0436 trial ( | PMC10122174 | ||
Patient, Tumor, and Treatment Characteristics | ONCOLOGY | Abbreviations: Gy, gray; RT, radiation therapy; RTOG, Radiation Therapy Oncology Group.Race and ethnicity were derived from electronic health records.Other category included Black, Asian, and other in the RTOG 8501 trial; Black or African American, Hispanic, Native American (Aleutian, American Indian, and Eskimo), Nati... | PMC10122174 | |
Outcomes for RT Duration Dichotomized by X-Tile Software Cut Point | In univariable analysis, RT duration longer than 45 days (vs ≤45 days) was associated with inferior LRF and DFS and a pattern of inferior OS (eFigure 1 in | PMC10122174 | ||
Outcomes for RT Duration as a Continuous Variable | ONCOLOGY | After controlling for an NRG Oncology trial, a 1-week increase in RT duration was associated with a 17% increased risk of having a DFS failure (HR, 1.17; 95% CI, 1.04-1.32; | PMC10122174 | |
Outcomes for RT Duration Dichotomized by Median | In univariable analysis, RT duration longer than 39 days (vs ≤39 days) was associated with a higher risk of LRF but not DF, DFS, or OS (eFigure 2 in | PMC10122174 | ||
Outcomes for RT Interruptions | In univariable analysis, patients with RT interruptions (vs no interruptions) had patterns of inferior DFS and LRF (eFigure 3 in | PMC10122174 | ||
Discussion | esophageal cancer, cancer | ESOPHAGEAL CANCER, OESOPHAGEAL CANCER, CANCER, SECONDARY, ONCOLOGY | In this secondary analysis of patients with esophageal cancer treated with definitive CRT in NRG Oncology trials, the frequency of RT interruptions and the length of RT duration were characterized. The association between RT interruptions and RT duration and outcomes, including LRF, DFS, and OS, was examined. Key findi... | PMC10122174 |
Strengths and Limitations | cancer | ONCOLOGY, CANCER | Strengths of this study included the prospective data collection using NRG Oncology trials. Length of follow-up was relatively long, with a median follow-up of 4 years for surviving patients. Additionally, the cohort was relatively large with a relatively uncommon cancer.Study limitations included the cohort not being ... | PMC10122174 |
Conclusions | ONCOLOGY, SECONDARY | In this secondary analysis of 3 NRG Oncology randomized clinical trials, prolonged RT duration was associated with inferior outcomes. Female patients and those with other race and ethnicity were more likely to have prolonged RT duration and experience RT interruptions. Radiotherapy interruptions should be minimized to ... | PMC10122174 | |
Background | GDM, pain | GDM, GESTATIONAL DIABETES MELLITUS | Edited by: Chunjiang Wang, Central South University, ChinaReviewed by: Yunping Li, Beth Israel Deaconess Medical Center and Harvard Medical School, United States; Shanglong Yao, Huazhong University of Science and Technology, ChinaPregnant women with gestational diabetes mellitus (GDM) require more analgesics after cesa... | PMC10454896 |
Methods | GDM, pain | GDM, SECONDARY | One hundred forty pregnant women with GDM were enrolled participate in this randomized controlled trial and were randomized into two groups (70 in each group). The esketamine (S) group was given esketamine +sufentanil + ondansetron, and the control (C) group was given sufentanil +ondansetron. The primary outcome is suf... | PMC10454896 |
Results | pain | Compared with group C, group S had significantly lower sufentanil consumption at 6 and 24 hours postoperatively (P= 0.049 and P<0.001), significantly lower activities VAS(pain during activities)scores at 6 hours postoperatively, rest and activities VAS (pain at rest and pain during activities)scores at 24 hours postope... | PMC10454896 | |
Conclusion | GESTATIONAL DIABETES | Compared to sufentanil PCA, adding low dose of esketamine significantly reduced the consumption of sufentanil while providing equally effective post cesarean analgesia in the patients with gestational diabetes. | PMC10454896 | |
Background | GDM | GDM, COMPLICATION OF PREGNANCY | GDM is a common complication of pregnancy, and the incidence of GDM rapidly increased in recent years (Esketamine is a noncompetitive antagonist of the N-methyl-D-aspartate receptor (NMDA receptor), which binds to the NMDA receptor and blocks the NMDA receptor from binding to glutamate to exert analgesic and antinocice... | PMC10454896 |
Materials and methods | PMC10454896 | |||
Study design | This prospective study was approved by the Ethics Committee of Hunan Provincial Maternal and Child Health Hospital [No. 2020-S068], and the study participants signed the informed consent form and was conducted between March 1, 2021 and December, 2022. | PMC10454896 | ||
Population selection criteria | GDM, diabetes mellitus, opioid dependence, pain | GDM, DIABETES MELLITUS, ADVERSE EVENT | Full-term singleton pregnancies with GDM (those with ASA scores of I-II) were included. Exclusion criteria: (1) patients with ASA scores of III and above; (2) patients with contraindications to neuraxial anesthesia; (3) patients with a history of opioid dependence; (4) patients who were diagnosed as having diabetes mel... | PMC10454896 |
Interventions | Pain, sinus bradycardia, blood loss, hallucinatory, pain, dizziness, GDM, nausea, vomiting | SINUS BRADYCARDIA, BLOOD LOSS, GDM, ADVERSE EFFECTS, DECUBITUS | We screened 150 patients with GDM undergoing elective cesarean section, and then 140 patients were enrolled based on inclusion, exclusion and withdrawal criteria. They were randomly divided into the esketamine (S) group, esketamine 0.5 mg/kg + sufentanil 150ug + ondansetron 4mg and the control (C) group,sufentanil 150u... | PMC10454896 |
Outcomes | postoperative nausea, vomiting, dizziness, hallucinations | ADVERSE EFFECTS, SECONDARY | The primary outcome was sufentanil consumption at 24 hours postoperatively, and secondary outcomes were sufentanil consumption at 6 hours postoperatively, VAS scores at rest and during activities at 6, 24, and 48 hours postoperatively, time to bowel function return(the time to pass flatus as the sign of bowel function ... | PMC10454896 |
Sample size | The primary endpoint of this study was the consumption of sufentanil at 24 hours after surgery. We used a two-tailed test with α = 0.05 and β = 0.1 based on the pre-experimental 24-hour postoperative sufentanil consumption in groups S (95.1 ± 5.5) and C (99.3 ± 7.0), with a minimum of 60 patients required in each group... | PMC10454896 | ||
Randomization and blinding | The investigators used the SAS statistical software package on a computer to generate random numbers in a 1:1 ratio to determine groups S and C. Neither the blinded investigators (the surgeon and the anesthesia resident physician) nor the patients were aware of the study groupings. Before the patients entered the opera... | PMC10454896 | ||
Statistical analysis | SPSS 25.0 was used for the statistical analysis, and a P value < 0.05 was considered statistically significant. Continuous variables were analyzed with the Mann-Whitney U test or independent samples t test, and the Kolmogorov-Smirnov test was performed first to confirm whether the data were normally distributed. Normal... | PMC10454896 | ||
Results | GDM | GDM, DIABETES MELLITUS, GESTATIONAL HYPERTENSION | A total of 150 women with GDM were screened in this study from March 2021 to December 2022. Based on exclusion criteria, 10 women with GDM were excluded prior to randomization (6 with GDM combined with gestational hypertension, 2 with contraindications to neuraxial anesthesia, and 2 with a prepregnancy diagnosis of dia... | PMC10454896 |
Demographic data | There were no significant differences in the basic information of the two groups, including age, height, weight, gestational week, number of cesarean deliveries, preoperative glucose, and duration of surgery (Demographic data.
| PMC10454896 | ||
Comparison of the postoperative analgesic effects between groups | Compared with group C, sufentanil consumption was significantly reduced in group S at 6 and 24 hours postoperatively (P=0.049 and P<0.001),The activities VAS scores at 6 hours, the rest and activities VAS scores at 24 hours, the activities VAS scores at 48 hours were significantly lower in group S (P=0.022, P=0.002, P=... | PMC10454896 | ||
Comparison of the postoperative adverse effects between groups | dizziness, nausea, vomiting | ADVERSE EFFECTS | Compared with group C, the time to bowel function return (P=0.031) was significantly shorter in group S, and there was no significant difference in the time to first lactation (Comparison the postoperative adverse effects between Groups.
There was no significant difference in the postoperative adverse effects (nausea, ... | PMC10454896 |
Discussion | gestational diabetes, gastrointestinal adverse, breast milk, pain, hyperglycemia, dizziness, GDM, hallucinations, hypertension, nausea, vomiting | GESTATIONAL DIABETES, ADVERSE EFFECT, GDM, HYPERGLYCEMIA, ABNORMAL THYROID, COMPLICATED PREGNANCIES, HYPERTENSION | This randomized controlled trial evaluated the postoperative analgesic regimen for GDM women undergoing cesarean delivery. Our results showed that low-dose esketamine combined with sufentanil PCA in group S not only reduced the amount of sufentanil used at 6 and 24 hours postoperatively in GDM women undergoing cesarean... | PMC10454896 |
Conclusion | GDM | GDM | In conclusion, based on the results from our study, it can be concluded that low-dose esketamine combined with sufentanil for intravenous patient-controlled analgesia can reduce the amount of sufentanil and enhance the analgesic effect after cesarean section in women with GDM, providing new data for the analgesic proto... | PMC10454896 |
Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC10454896 | ||
Ethics statement | The studies involving human participants were reviewed and approved by Hunan Provincial Maternal and Child Health Hospital. The patients/participants provided their written informed consent to participate in this study. | PMC10454896 | ||
Author contributions | LC and TH designed the study. TH and QC organized the data. JZ and JH analyzed the data and wrote the first draft of the manuscript. AL, WX, ZL, and ZP revised the manuscript. All the authors contributed to the article and approved the submitted version. | PMC10454896 | ||
Acknowledgments | We are deeply grateful to all the participants of this study. We would like to thank all the people who contributed to this study. | PMC10454896 | ||
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. | PMC10454896 | ||
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 ... | PMC10454896 | ||
References | PMC10454896 | |||
1. Introduction | gastrointestinal distress, weight loss, chronic disease | ADVERSE EVENTS, SECONDARY, CHRONIC DISEASE | Exogenous ketone ester and ketone ester mixed with ketone free acid formulations are rapidly entering the commercial marketspace. Short-term animal and human studies using these products suggest significant potential for primary or secondary prevention of a number of chronic disease conditions. However, a number of que... | PMC10708260 |
2. Materials and Methods | ADVERSE EVENTS | Fourteen participants between the ages of 18 and 25 years with a body mass index (BMI) between 18.5 and 29.9 kg/mThe exogenous ketones used in this study were purchased from KetoneAid (Falls Church, VA, USA) and included a KME and a KMES drink. The drinks provided at each condition were diluted with water to a total vo... | PMC10708260 | |
3. Results | PMC10708260 | |||
3.1. Participant Recruitment and Characteristics | Fifteen individuals volunteered for this study and were screened for eligibility with one excluded for not meeting the BMI requirements (Participant retention was 100% with all 14 participants who joined this study completing each of the five conditions. Participant characteristics are shown in | PMC10708260 | ||
3.2. Effects of KME and KMES Drinks on Circulating R-βHB and Glucose Concentrations | There were no significant differences in R-βHB and glucose responses or other variables observed between male and female participants. Thus, results are presented with data from male and female participants combined. R-βHB concentrations were significantly higher than baseline for each condition (Glucose concentrations... | PMC10708260 | ||
3.3. Acceptability and Tolerability of KME and KMES Drinks | nausea | Although taste was not quantitatively assessed, participants were encouraged to explain the flavor of each study drink either by writing in the “Additional Comments” section of the questionnaire or by verbally reporting to the research team; these data are shown in All reported side-effects were reported as “mild” exce... | PMC10708260 | |
4. Discussion | gastrointestinal distress | ADVERSE EFFECTS, SECONDARY | The purpose of the current investigation was to examine the tolerability and acceptability of a KME and KMES drink and their effects on circulating R-βHB and glucose concentrations in healthy young adults. Our hypothesis was that KME would raise circulating ketone concentrations to a greater magnitude and duration than... | PMC10708260 |
Author Contributions | Conceptualization, M.L.B., R.D.S., G.F. and E.P.P.; methodology, M.L.B., K.R.F., R.D.S., G.F. and E.P.P., formal analysis, E.P.P.; investigation, M.L.B., C.M.G. and E.P.P.; resources, E.P.P.; data curation, M.L.B. and E.P.P.; writing—original draft preparation, M.L.B. and E.P.P.; writing—review and editing, M.L.B., K.R... | PMC10708260 | ||
Institutional Review Board Statement | This study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of the University of Alabama at Birmingham (protocol code IRB-300009075, date of approval 09/22/2022). | PMC10708260 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in this study. | PMC10708260 | ||
Data Availability Statement | The data in this study are available on request. | PMC10708260 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of this study; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results. | PMC10708260 | ||
Purpose | prostate cancer | PROSTATE CANCER, URINARY INCONTINENCE | The study compared the efficacy of commencing supervised exercise in men with prostate cancer before and after prostatectomy on objective and patient-reported outcomes, hospital length of stay, and urinary incontinence. | PMC10645629 |
Methods | urinary incontinence, fatigue | PAD, URINARY INCONTINENCE | Forty-one men were randomised to a 6-week prehabilitation or rehabilitation exercise programme. Prehabilitation involved resistance and aerobic exercise thrice weekly pre-surgery, while rehabilitation comprised the same commencing 6-weeks post-surgery. Assessments included strength, function (chair rise, stair climb, 4... | PMC10645629 |
Results | URINARY INCONTINENCE | Of thirty-eight men (48–73 years), 29 completed all assessments with most undergoing robotic-assisted laparoscopic prostatectomy (92.1%). In the pre-surgery phase, prehabilitation improved muscle strength (leg press: 17.2 kg; chest press: 2.9 kg; p ≤ 0.001), 400-m, chair rise, 6-m fast and backward walk tests (p ≤ 0.00... | PMC10645629 | |
Conclusion | Pre-surgical exercise enhanced strength and function, protecting against post-surgery declines. Although exercise post-surgery is beneficial for recouping strength and function, where possible men undergoing prostatectomy are encouraged to exercise pre-surgery. | PMC10645629 | ||
Trial registration | ACTRN12617001115325 registered 31 July 2017. | PMC10645629 | ||
Supplementary Information | The online version contains supplementary material available at 10.1007/s00432-023-05409-3. | PMC10645629 | ||
Keywords | Open Access funding enabled and organized by CAUL and its Member Institutions | PMC10645629 | ||
Introduction | cancer, Prostate cancer | CANCER, PROSTATE CANCER | Prostate cancer is the most diagnosed cancer in men in Western countries such as the United States, United Kingdom and Australia (AIHW Although we (Singh et al. | PMC10645629 |
Materials and methods | Forty-six patients were referred for participation between June 2016 and September 2018 in Perth, Western Australia, and their progress through the study is shown in Fig. Study flow chart | PMC10645629 | ||
Study design | urinary incontinence, fatigue | URINARY INCONTINENCE | This randomised controlled trial compared the effectiveness of a 6-week supervised multimodal exercise programme before surgery (Prehabilitation) versus the identical exercise programme delivered post-surgery (Rehabilitation) in patients undergoing prostatectomy. Patients were randomly assigned using a computer random ... | PMC10645629 |
Exercise programme | Exercise was undertaken thrice weekly in small groups of 5–8 participants, supervised by accredited exercise physiologists in an exercise clinic. Each session was ~ 90 min and included resistance and aerobic exercises. Resistance training consists of exercises targeting major muscle groups, such as leg press, leg exten... | PMC10645629 | ||
Primary and secondary endpoints | The primary study endpoint was dynamic muscle strength for the chest press and leg press using one-repetition maximum (1-RM) (Taaffe et al. | PMC10645629 | ||
Other measures | DISEASE | Demographic and clinical data including disease stage, comorbidities, surgical approach and medications were recorded and collected by self-report records. Height and body weight were assessed, with body mass index (BMI, kg.m | PMC10645629 | |
Statistical analysis | The sample size estimate was based on projected changes in muscle strength (Galvão et al. Data were analysed using IBM SPSS version 27 (SPSS Inc., IBM Corp., Armonk, NY, USA). Normality of the distribution for outcome measures was evaluated using the Kolmogorov–Smirnov test. Differences in baseline characteristics betw... | PMC10645629 | ||
Muscle strength | There were no differences between groups at baseline (Fig. Muscle strength absolute values and change over the assessment time points. Results are presented as mean and standard error. | PMC10645629 | ||
Physical function | There was no difference between groups at baseline for physical function (p = 0.060–0.685). Over the study period, there were no significant interactions except for 6-m usual walk (p = 0.033) and a significant time effect for 400-m walk, chair rise, stair climb, 6-m fast and backward walk tests (p = < 0.001–0.001) (Fi... | PMC10645629 | ||
Body composition | At baseline, prehabilitation had lower whole-body LM (p = 0.007) and trunk FM (p = 0.038) compared to rehabilitation (Table Body composition outcomes at baseline, pre-surgery, and 6 and 12 weeks post-surgery*Within-group multiple comparisons for baseline, pre-surgery, 6 and 12-weeks post-surgery, with a Bonferroni-corr... | PMC10645629 | ||
Urinary incontinence and length of hospital stay | urinary incontinence | URINARY INCONTINENCE | At 2 weeks post-surgery, there was no difference between groups for urinary incontinence (p = 0.790) (Table | PMC10645629 |
Discussion | cancer, prostate cancer, urinary incontinence, fatigue | CANCER, PROSTATE CANCER, URINARY INCONTINENCE, POSTOPERATIVE COMPLICATIONS | In this study, we compared prehabilitation and rehabilitation supervised exercise in the setting of prostatectomy. There were three main findings. First, 6 weeks of supervised exercise before prostatectomy enhanced muscle strength, physical function at pre-surgery and at 6 weeks post-surgery despite reductions in lean ... | PMC10645629 |
Acknowledgements | Daniel A. Galvão, Prostate Cancer | PROSTATE CANCER | We acknowledge all the participants who despite their difficult schedules provided the time to participate and contribute to this study. Special acknowledgement also goes to the support staff, both administration and the research assistants, in assisting in their various capacities. Pedro Lopez is supported by the Nati... | PMC10645629 |
Author contributions | RECRUITMENT | FS: had full access to all data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. FS, RUN, DAG, and DRT: contributed to the study conception and design. Patient recruitment was contributed by FS, JT, MB, EO, and DH. Material preparation, data collection and analy... | PMC10645629 | |
Funding | Open Access funding enabled and organized by CAUL and its Member Institutions. This work was supported by funding through the Edith Cowan University Early Career grant fund (Grant Number: G1002267). | PMC10645629 | ||
Availability of data and material | The datasets generated during and/or analysed during the current study are available from the corresponding author upon reasonable request. | PMC10645629 | ||
Declarations | PMC10645629 | |||
Conflict of interest | The authors declare that they have no conflicts of interest and have no relevant financial or non-financial interests to disclose. | PMC10645629 | ||
Ethical approval | This study was performed in line with the principle of the Declaration of Helsinki. Ethics approval has been obtained from the Human Research Ethics Committee of Edith Cowan University (14320_Singh) and the South Metropolitan Health Service (2016–171). | PMC10645629 | ||
Consent to participate | Informed consent was obtained from all individual participants included in the study. | PMC10645629 | ||
References | PMC10645629 | |||
Methods | Process evaluation data were collected alongside intervention data and included both quantitative and qualitative data sources. Midwives at the health facilities which were randomized as intervention sites completed tracking logs to measure feasibility of the intervention. Research team members traveled to intervention... | PMC10629640 | ||
Results | In the majority of cases, midwives facilitating group antenatal care completed all components of the meetings with fidelity, following best practices such as sitting with the group rather than standing. Across 7 intervention sites, 7 groups (622 pregnant women) were documented in the tracking logs and of these particip... | PMC10629640 | ||
Conclusion | This process evaluation determined that group antenatal care can be implemented with fidelity in low and middle-income countries. Time management was the biggest challenge, however both midwives and pregnant women found the model of care not only acceptable, but preferable to traditional care. The knowledge shared and ... | PMC10629640 | ||
Data Availability | The data is available on Deep Blue: | PMC10629640 | ||
Introduction | deaths | COMPLICATION | Maternal and infant health have long been at the forefront of global health initiatives. Through concerted efforts to improve maternal and newborn health, some progress has been made. In 1990, newborn deaths worldwide were 5 million and by 2019 that had decreased to 2.4 million [Antenatal care (ANC) defined by the Worl... | PMC10629640 |
Components of the GRAND—Group antenatal care model. | The purpose of this process evaluation was to identify and document barriers and facilitators to implementation of the group ANC intervention. Using both quantitative and qualitative methods, we aimed to identify potential and actual influences on the quality and conduct of the intervention’s operations, implementation... | PMC10629640 | ||
Methods | PMC10629640 | |||
Overview of the intervention | During the summer of 2019, research team members with expertise in group ANC from the United States met with research partners in Ghana to conduct a train-the-trainer course for a selected group of midwives that would then serve as champions to train the midwives working at the intervention sites. The training was unde... | PMC10629640 | ||
Process evaluation design | Following the midwife facilitator training, the champion trainers as well as other members of the Ghana research team received additional training in the data collection methods for the process evaluation of group ANC including facilitation of focus groups among pregnant women participating in group ANC at the interven... | PMC10629640 |
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