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Data sources for process evaluation. | PMC10629640 | |||
Study setting | Fourteen health centers in eastern Ghana that provided antenatal care were included in the GRAND study. Only the 7 sites randomized for the group ANC intervention were included for collection of process evaluation data since the evaluation was of group ANC implementation. Research team members traveled to the health fa... | PMC10629640 | ||
Participants | PMC10629640 | |||
Midwife facilitators | Midwife facilitators In order to assess fidelity to the model of group ANC and to determine if all content was covered, structured observations were conducted by research team members with midwife facilitators as participants. Inclusion criteria was; being a midwife who had completed training was facilitating group ANC... | PMC10629640 | ||
Women participating in Group ANC | For the outcome evaluation, data were collected from all women participating in group ANC with a corresponding number of participants at the control groups sites. Outcome data collection is still underway. However, for the process evaluation, focus group data was collected from a subset (1–2 groups) of participants enr... | PMC10629640 | ||
Data collection process | PMC10629640 | |||
Structured observations | A sample of group ANC meetings were observed for each midwife facilitator to monitor fidelity to the model. Beginning with the initial groups in fall 2019, and continuing at intervals throughout the study period, members of the Ghana research team who had also participated as champion trainers traveled to the intervent... | PMC10629640 | ||
The fidelity checklist | This scale consists of 7 items scored as “Always”, “Sometimes” or “Never”. The items identify whether or not the midwife facilitator is using the techniques taught to encourage group dynamics and discussion. For example, the midwife should sit in the group rather than stand when conducting the meeting. Additional space... | PMC10629640 | ||
The learning methods checklist | This is a 16-item checklist that identifies whether or not the midwife follows the format spelled out in the group ANC Facilitators Guide. The format is intentionally prescriptive to ensure all topics are adequately covered and there is group discussion around the topics. For this checklist, observers were instructed t... | PMC10629640 | ||
Interviews | A face-to-face semi-structured interview was completed with a midwife facilitator from each intervention site (N = 7) following the structured observation of the group ANC meeting The purpose was to explore the midwives’ perceptions of which components of the intervention were successfully implemented, to identify barr... | PMC10629640 | ||
Tracking logs | A brief form was completed by the midwife facilitator each time a group ANC meeting was held to track the date of the meeting and the number of participants from the group in attendance. This measured “dose”, or amount of the intervention each participant received for analysis of outcomes as well as feasibility by dete... | PMC10629640 | ||
Focus groups | For each intervention site at least one focus group discussion was held with pregnant women participating in group ANC. These focus groups, conducted by a member of the research team trained in qualitative data collection methods, were held at the end of the group ANC meeting and were voluntary; women were welcome to l... | PMC10629640 | ||
Data analysis | Quantitative data (Fidelity Checklist and Learning Methods Checklist) were collected by the research team members during the observation of the group ANC then entered into an Excel spreadsheet. Data were analyzed descriptively to assess whether certain items, midwives, or intervention sites were performing less well wh... | PMC10629640 | ||
Ethics statement | The study aims and design were developed in collaboration with community members of the research team. The study was approved by the Ethical Review Committee of the Ghana Health Service and the University of Michigan Institutional Review Board (HUM00161464).With IRB approval, oral consent was obtained from participants... | PMC10629640 | ||
Results | PMC10629640 | |||
Checklists | The Fidelity Checklist consists of 7 items intended to assess whether the facilitator uses techniques intended to encourage group dynamics and discussion. A total of 32 Fidelity Checklist Scales were completed by the champion trainers as they observed group ANC meetings among the intervention sites. The majority of the... | PMC10629640 | ||
Fidelity scale scoring. | The Learning Methods Checklist with 16 items identifies which steps may have been missed in the meeting format. In most cases, observers indicated that all steps were followed, with only two observations indicating that the midwife did not “Go through the what and why” step of explaining what actions are needed when a ... | PMC10629640 | ||
Tracking logs | There was a total of 70 groups tracked across the 7 intervention sites between August 2019 and April 2022 ( | PMC10629640 | ||
Tracking logs. | PMC10629640 | |||
Interviews with midwives | One-to-one interviews using a semi-structured interview guide were conducted by research team members with group ANC midwives at each of the 7 intervention sites (N = 7). Three themes were identified: 1) information sharing, 2) sense of community, and 3) time management challenges. | PMC10629640 | ||
Information sharing | Midwives identified that they enjoyed sharing information with participants in a setting that offered the opportunity for group participation | PMC10629640 | ||
Sense of community | Midwives felt that group ANC was beneficial in creating a sense of community among the women where information and support was coming from other women and not just from the midwife | PMC10629640 | ||
Time management challenges | Midwives indicated that starting on time was a challenge because not all of the women were there on time, and they needed to decide whether to finish all the material or end on time. They expressed optimism that time management would get easier with subsequent meetings: | PMC10629640 | ||
Focus groups with participants | A total of 10 focus group discussions with a total of 92 participants (5–13 women per group) were conducted after the final group ANC meetings. One focus group was conducted at 4 intervention sites and 2 focus groups were conducted at 3 of the sites. Some women in the groups had already delivered and attended with thei... | PMC10629640 | ||
Sense of community | Some participants expressed initial reluctance to participate that was quickly overcome. “Participants in each group expressed their happiness that the midwives demonstrated respectful maternity care. Women came back after their babies were born to share with others. They expressed a desire to continue group ANC so oth... | PMC10629640 | ||
Information sharing | Participants were able to recall all topics covered. What is evident from the data is that it was important to participants that the Participants expressed enthusiasm for the group ANC model of care where participants check one another’s blood pressure and weights with the supervision of the midwife, expressing feeling... | PMC10629640 | ||
Time management challenges | Similar to the interviews with midwives, this issue was mentioned in every group. Participants shared that it was hard for them to arrive on time. | PMC10629640 | ||
Disconnect | At times participants who had already given birth saw a disconnect between the group ANC teaching and the birth experience. In other words, participants were empowered to advocate but on the maternity ward they were not always treated with respect. One participant recalled being discounted by the staff: “ | PMC10629640 | ||
Discussion | Maternal and infant mortality in LMICs remains unacceptably high and women and infants that survive pregnancy and childbirth often suffer long term sequalae. Often, the traditional approach to ANC provides little in the way of education and counseling about health-promoting behaviors. To provide the most benefit, ANC m... | PMC10629640 | ||
Facilitators and barriers | PMC10629640 | |||
System | Training adequate numbers of facilitators in this model of group ANC can be time consuming and costly. Using a train-the-trainer model of implementation, we were able to train champion trainers who then trained midwives at the intervention sites which increased efficiency. Training workshops occurred in small groups si... | PMC10629640 | ||
Midwives | The midwives were able to administer the group ANC curricula with fidelity to the format using the techniques they learned and practiced in the training. The midwives that were interviewed all expressed a preference for group ANC over the standard, individual care model, feeling like it resulted in more education and a... | PMC10629640 | ||
Pregnant women | The research team was able to recruit pregnant participants willing to enroll in the study and participate in group ANC despite some delay due to the COVID pandemic. Of the participants, the majority attended four or more of the 8 meetings. One approach to encouraging attendance was reminder texts and phone calls by th... | PMC10629640 | ||
Limitations | Implementation of the group ANC intervention and the ensuing process evaluation were impacted by the pandemic, as described above. However, the research team in Ghana and the midwife facilitators were committed to the program success. Fortunately, most of the group meetings were held outside which limited risk of COVID... | PMC10629640 | ||
Conclusion | Significant shifts in clinical practice do not happen easily or quickly. Valid, reproducible evidence must exist for practice guidelines to change. Implementation of group ANC in this context was not without challenges, one of which was time management, however our findings contribute to the growing evidence that group... | PMC10629640 | ||
Supporting information | PMC10629640 | |||
Fidelity checklist. | (DOCX)Click here for additional data file. | PMC10629640 | ||
Learning methods checklist. | (DOCX)Click here for additional data file. | PMC10629640 | ||
Tracking log. | (DOCX)Click here for additional data file. | PMC10629640 | ||
Consolidated criteria for reporting qualitative research (COREQ) checklist. | (DOCX)Click here for additional data file. | PMC10629640 | ||
PLOS ONE questionnaire on inclusivity. | (DOCX)Click here for additional data file. | PMC10629640 | ||
Abstract | PMC10278510 | |||
Background | cancer, Type 2 diabetes, T2D | CANCER, TYPE 2 DIABETES | Undiagnosed Type 2 diabetes (T2D) has been associated with advanced stage cancer at diagnosis, higher mortality, and lower long‐term all‐cause survival. This was a RCT pilot study to examine the feasibility of a nurse‐led T2D intervention for adults with newly diagnosed cancer (≤3 months), and T2D, undiagnosed or untre... | PMC10278510 |
Methods | diabetes | DIABETES | Participants needed to meet the eligibility criteria including a HbA1c level between 6.5% and 9.9%. Randomization was 1:1 to a 3‐month intervention that consisted of nursing‐led diabetes education and immediate initiation of metformin versus referral to primary care for usual care (control). | PMC10278510 |
Results | Three hundred and seventy nine patients were screened using EHR, 55 agreed to participate, and 3 had eligible HbA1c levels and were randomized in the study. Primary reasons for study exclusion included life expectancy ≤2 years (16.9%), current use or inability to tolerate metformin (14.8%), and abnormal labs that contr... | PMC10278510 | ||
Conclusion | cancer, Type 2 diabetes, T2D, Nelson | CANCER, TYPE 2 DIABETES, RECRUITMENT, NELSON | This study was not feasible due to recruitment inefficiencies, but acceptable to all who qualified.Undiagnosed Type 2 diabetes (T2D) has been associated with advanced stage cancer at diagnosis, higher mortality, and lower long‐term all‐cause survival. This was a pilot RCT study to examine the feasibility of a nurse‐led... | PMC10278510 |
BACKGROUND | diabetes, T2D, cancer, Cancer | DIABETES, CANCER, CANCER | Cancer and diabetes are highly prevalent in the United States.Nurses are uniquely positioned to fill critical gaps between T2D and cancer care. A nurse‐led intervention using first‐line treatment for T2D may improve the current standard of care to detect and manage undiagnosed T2D in newly diagnosed cancer patients. | PMC10278510 |
METHODS | PMC10278510 | |||
Study design and population | diabetes, cancer, T2D, RA | CANCER, PCP, DIABETES | This was a pilot, parallel‐group randomized controlled trial (RCT) feasibility study in adults with newly diagnosed cancer and undiagnosed or untreated T2D to test a nurse‐led 3‐month intervention for managing T2D. The study took place from November 2020 to November 2021, with a pause due to COVID‐19 restrictions and r... | PMC10278510 |
Feasibility metrics | diabetes | RECRUITMENT, DIABETES | Recruitment efficiency, retention rates, acceptability, and diabetes self‐management were assessed. At the 3‐month follow‐up, all participants completed a valid and reliable study acceptability scale that included topics such as (1) screening process; (2) time commitment; (3) education content; and (4) patient satisfac... | PMC10278510 |
Statistical analysis | The data, stored in the REDCap database, were exported to R statistical software for analysis. R studio version (2022.02.2 + 485) was used to calculate descriptive statistics for feasibility metrics (frequency, percentage, mean) and sociodemographic characteristics of screened patients. Pretest and posttest HbA1c level... | PMC10278510 | ||
RESULTS | PMC10278510 | |||
Participants | leukemia or pancreatic cancer | A total of 379 patients were screened using the EHR, 94 patients met criteria and were approached in clinic with 59% (55/94) agreeing to POC HbA1c testing. Primary reasons for study exclusion during prescreening included life expectancy ≤2 years and patients diagnosed with leukemia or pancreatic cancer (16.9%), current... | PMC10278510 | |
Feasibility metrics |
CONSORT diagram.
| PMC10278510 | ||
After 3 months, the HbA1c level of the intervention group participant ( | PMC10278510 | |||
DISCUSSION | cancer, comorbidity, T2D, diabetes | CANCER, DIABETES | This pilot study was closed due to failing feasibility metrics. The largest barrier was identifying eligible patients with POC HbA1c determinations. One way to improve identification of future patients would be to integrate HbA1c testing into order sets for all newly diagnosed cancer patients entering the clinic and br... | PMC10278510 |
CONCLUSIONS | cancer, T2D, diabetes | CANCER, DIABETES | Despite a number of patients being interested in participating, only three were enrolled in this study. This study was not feasible due to the cost, time, and personnel needed to screen participants with a POC HbA1c test. This suggests a willingness and interest for patients to participate, but reliance on POC HbA1c te... | PMC10278510 |
AUTHOR CONTRIBUTIONS | PMC10278510 | |||
FUNDING INFORMATION | Cancer | CANCER | Support was provided by the University of Florida Cancer Center pilot grant CPS‐FY20‐01 and Grant Numbers U54CA233444, U54CA233396, and U54CA233465 from the National Institutes of Health (NIH), National Cancer Institute (NCI). The content is solely the responsibility of the authors and does not necessarily represent th... | PMC10278510 |
CONFLICT OF INTEREST STATEMENT | No potential conflicts of interest relevant to this article were reported. | PMC10278510 | ||
ETHICS STATEMENT | All participants completed and signed an informed consent form prior to completing the in‐clinic point‐of‐care (POC) HbA1c test. If enrolled in the study, participants then completed and signed a second consent. This pilot study was approved by the IRB of the University of Florida, IRB # IRB201902145. | PMC10278510 | ||
Supporting information |
Click here for additional data file. | PMC10278510 | ||
ACKNOWLEDGMENTS | The authors would like to thank the Biostatistics and Computational Biology Shared Resource at the University of Florida for their statistical support in this study. | PMC10278510 | ||
DATA AVAILABILITY STATEMENT | The data generated from this study are available from the corresponding author upon reasonable request. | PMC10278510 | ||
REFERENCES | PMC10278510 | |||
Subject terms | rheumatoid arthritis, RA | RHEUMATOID ARTHRITIS, PROLIFERATION, INFLAMMATION, DNA DAMAGE, DISEASE, DISEASE, PATHOGENESIS | The pathogenesis of rheumatoid arthritis (RA) is characterized by a Th17/Treg cell imbalance. A pro-inflammatory cytokine milieu that promotes the continued proliferation of Th17 cells is related to the development of autoinflammation. In RA, T cells have several hallmarks of cellular aging, and they accumulate DNA dam... | PMC10495372 |
Introduction | autoimmune diseases, articular damage, Rheumatoid arthritis, RA, autoimmune disease | DISEASE, AUTOIMMUNE DISEASES, RHEUMATOID ARTHRITIS, CHRONIC INFLAMMATION, AUTOIMMUNITY, PATHOGENESIS, AUTOIMMUNE DISEASE | Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disease of multifactorial origin that develops due to unfavorable coincidence of genetic, immune, and environmental factorsT helper 17 (Th17) and regulatory T cells (Treg cells) are both differentiated from the same naive CD4+ T cells, but in separate cytok... | PMC10495372 |
Results | PMC10495372 | |||
Overview of enrollment | A total of 105 individuals were screened for eligibility, out of which 64 were randomized into 2 groups (each group A consort flow diagram of the study. | PMC10495372 | ||
Participants’ baseline characteristics | co-morbidity | DISEASE | Baseline demographic and clinical characteristics of all randomized participants are shown in Table Baseline characteristics. Data were described as frequency (%) for sex, drug therapy, stratification by disease severity, co-morbidity and mean ± SD for others. One asterisk (*) indicates a p-value ≤ 0.05; two asterisks ... | PMC10495372 |
Group × gender interactions | DISEASE | There was no significant difference in mean DAS28-ESR values between males and females at baseline (DAS28-ESR values 4.7Gender interactions for change in disease activity after the intervention. Mean change of DAS28-ESR score with 95% CI for males in the yoga and the control groups; p = 0.6629 for between-group differe... | PMC10495372 | |
Post-intervention differences in disease activity | There was a significant reduction in DAS28-ESR scores among the participants of yoga group [0.49, 95% (0.13 to 0.85)] with a significant interaction of group and time (ηpIntent-to-treat analysis: means (SD) and results of within-group and between-group analysis of primary outcomes ( | PMC10495372 | ||
Post intervention differences in molecular markers | PMC10495372 | |||
T cell subsets | The representative graphics from flow cytometry for Th17 and Treg cells measurements are depicted in Supplementary Fig. Frequency of Th17, Treg, aged Th17, and aged Treg cells in the yoga group and non-yoga group [p value (ns = p > 0.05; *p ≤ 0.05; **p ≤ 0.01;***p ≤ 0.001)]. | PMC10495372 | ||
Markers of immune aging | A significant overall decline in the mean percentage of aged Th17 cells (CD3 | PMC10495372 | ||
Inflammatory markers | There were significant changes observed in various inflammatory markers after 8-weeks of intervention in yoga group as compared to non-yoga group. Pro-inflammatory cytokines like IL-6 [0.54, 95% CI (0.22 to 0.85); ηp | PMC10495372 | ||
Epigenetic alterations | The percentage of global 5-mC was significantly higher in the yoga group as compared to the non-yoga group [−0.72, 95% CI (−1.3 to −0.16); ηp | PMC10495372 | ||
Gene expression levels | The results for expression analysis showed significant downregulation in relative mRNA expression levels of The relative mRNA expression levels of dysregulated transcripts in the yoga group and non-yoga group [p value (ns = p > 0.05; *p ≤ 0.05; **p ≤ 0.01;***p ≤ 0.001)]. | PMC10495372 | ||
Discussion | reduced disease, RA | INFLAMMATION, DISEASE, IMMUNOLOGICAL TOLERANCE, REMISSION, JOINT INFLAMMATION | Our study is the first to highlight the positive impact of yoga on modulation of the T cell subsets, T cell aging markers, epigenetic alterations and associated transcription factors in RA. We found that 8 weeks of yoga practice significantly reduced disease activity, normalized the biomarkers associated with inflammat... | PMC10495372 |
Methods | PMC10495372 | |||
Ethics declarations and study design | RA | DELHI | This study was a prospective, single-blinded, randomized controlled trial with active RA patients, aimed at analyzing the effects of an 8-week yoga practice in RA patients on standard drug therapy. The study was initiated after obtaining ethical clearance (IECPG-211/24.02.2016) from the Institute Ethics Committee of AI... | PMC10495372 |
Participants and eligibility criteria | RA | DELHI | The study participants were recruited from the outpatient unit of Rheumatology department of AIIMS, New Delhi. RA patients, 18–60 years old, diagnosed as per 2010 ACR/EULAR RA classification criteria | PMC10495372 |
Sample size calculation | EVANS | The sample size calculation for the study assumed to detect a standardized effect size [difference in mean change in DAS28-ESR between the two groups/pooled standard deviation (SD)] of 0.8 with a 95% confidence level and 80% power, considering the mean and SD of a previous study by Evans et al. (2011) | PMC10495372 | |
Randomization | For this investigator blinded study, sequentially labeled sealed opaque envelopes were used to conceal random numbers as described earlier | PMC10495372 | ||
Intervention | The participants were randomized into two groups- the yoga group and non-yoga group. All the study participants were asked to undergo a clinical evaluation and provide a blood sample on day 0 (baseline) and the end of 8 | PMC10495372 | ||
Yoga program (yoga group) | As described previously | PMC10495372 | ||
Usual care control (non-yoga group) | As described previously | PMC10495372 | ||
Outcome measures | PMC10495372 | |||
Primary outcome | DISEASE | The disease activity of the patients was assessed by DAS28-ESRChange in disease severity was measured by disease activity score—erythrocyte sedimentation rate (DAS28-ESR) from baseline (day 0) to 8-weeks and recorded as primary outcome. | PMC10495372 | |
Secondary outcome | All parameters were evaluated on day 0 (baseline) and 8th week (follow-up) of the intervention and the fasting blood samples were obtained at 8 am in the morning.Alterations in cellular and molecular markers including: (a) T cell subset population: Th17 (CD3+ CD4+ IL17+ RORγt+) cells and Treg (CD3+ CD4+ CD25+ CD127− Fo... | PMC10495372 | ||
Measurement of molecular markers | Following techniques were employed for the measurement of molecular markers: | PMC10495372 | ||
Phenotyping of T cell subsets by flow cytometry | The isolated PBMCs (1 × 10The isolated PBMCs (1 × 10 | PMC10495372 | ||
Detection of inflammatory and epigenetic markers | Serum levels of IL-6 (Gen-Probe, Diaclone Diagnostic, France), IL-17 (Gen-Asia Biotech, China), IL-10 (Bioassay Tech Laboratory, China), and HDAC1 (Qayee Bio-Technology) were estimated by ELISA using commercially available kits. Briefly, the workflow of the HDAC1 ELISA kit utilizes the sandwich ELISA methodology where ... | PMC10495372 | ||
Detection of gene expression patterns | As described earlierList of primer sequences.Forward: CCTGGGCTCCTCGCCTGACCReverse: TCTCTCTGCCCTCAGCCTTGCCForward: GTGGCCCGGATGTGAGAAGReverse: GGAGCCCTTGTCGGATGATGForward: CGGCTGGAGAAGATACTGGTReverse: TTAGTCCGAAATGAGGCTGTCForward: GGCACTGGCAGAAAACAACCReverse: GCAAGTCTCCTCATTGAATCCForward: GAAGGGAGACAATCGCTTTAGCReverse: ... | PMC10495372 | ||
Statistical analysis | All statistical analyses were carried out on an intent-to-treat basis with the baseline observation carried forward approach using IBM SPSS Statistics for Macintosh, Version 25.0. (IBM Corp. Armonk, NY, United States) and GraphPad Prism Version 6.01. (GraphPad Software, Inc., San Diego, CA). Chi-square test and Fisher’... | PMC10495372 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-42231-w. | PMC10495372 | ||
Acknowledgements | We are grateful to our yoga therapist, Ms. Richa Mishra, for her patience and expertise in managing the patients and to all the patients who participated in this study. | PMC10495372 | ||
Author contributions | Conceptualization, S.G. and R.D.; methodology, S.G., R.K., and S.K.; data analysis, S.G., R.K. and S.K.; investigation, S.G., R.K., and S.K.; resources, U.K. and K.L.; writing—original draft preparation, S.G.; writing—review and editing, all authors.; visualization, R.D.; supervision, K.L., U.K., and R.D.; project admi... | PMC10495372 | ||
Funding | We are thankful to the Department of Science and Technology (DST), India [SR/SATYAM/55/2016] for funding provided to RD. SG is supported by the Senior Research Fellowship (SRF) [45/2/2019-ANA/BMS] awarded by the Indian Council of Medical Research (ICMR), India. The funders had no role in the decision to publish or prep... | PMC10495372 | ||
Data availability | The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request. | PMC10495372 |
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