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Trial registration | ClinicalTrials.gov, | PMC10029790 | ||
Keywords | PMC10029790 | |||
Methods | PMC10029790 | |||
Data collection | Sources of child demographic and health history data included Head Start center records and self-administered parent questionnaires, which were available in English and Spanish. Estimates of family income and employment were derived using the child’s home address from the 2010 US Census block-level data. Parents reported child behaviors at home, including screen time, sleep, intake of fruit, vegetables, and sugar, and PA [ | PMC10029790 | ||
Parent-Reported PA | Parents were asked 5 specific questions related to time spent with children in various activities during a typical day (i.e., played outside with me, played outside with neighborhood children, played outside with other family members, played on a sports team, walked with me). Responses included “None”, “30 Minutes”, “1 Hour”, “2 Hours”, “3 Hours”, and “ ≥ 4 Hours”. A factor score was generated to indicate the level of child’s participation in PA with facilitation and/or supervision of adults at home or in the community. This tool was used in a previous study but has not been validated [ | PMC10029790 | ||
Screen and sleep time | Parents were instructed to document their child’s hours and minutes of screen time (i.e., video games, TV watching, phone/tablet) and sleep time, including nap time, at home for each day of the past week [ | PMC10029790 | ||
Food intake | To assess children’s dietary intake at home, parents completed a modified version of the validated National Health and Nutrition Examination Survey (NHANES; [Because the COVID-19 epidemic disrupted the program implementation and data collection in Spring 2020, this analysis included only data collected from August 2018 to June 2019. The COVID-19 pandemic did not affect the data collected during this period and what is reported in this manuscript. | PMC10029790 | ||
Statistical analysis | asthma, diabetes | ASTHMA, DIABETES | We employed descriptive statistics to summarize the demographic characteristics of both Head Start Centers and study participants as well as each outcome of interest (parent-reported PA, diet, screen time, and sleep time) measured at each time point (baseline vs. post-intervention). Baseline, post-intervention, and change scores (post-intervention – baseline) for each outcome of interest were compared among the three groups (CBI, CBI + HBI, Control) using the Kruskal–Wallis H test. For each outcome of interest, we used a 3-level (time nested within child, and child nested within center) linear mixed effects model (LMM) to examine the treatment effect. Two random effects were included in the LMM, one to account for the correlation among two measures nested within the same child, and the other to account for the correlation among children nested within the same center. We assumed data were missing at random. In LMM, time (baseline vs. post-intervention), treatment group (CBI vs. CBI + HBI vs. Control), the interaction between time and treatment group, and center size (large vs. small) were fixed design-related predictors that were always kept in the final model, regardless of whether they were statistically significant.We considered the following confounders in the full LMM for each outcome of interest: child’s age at baseline, gender, race/ethnicity, asthma, mother’s education, language spoken most often at home, parent marital status, family history of diabetes, and child’s BMI status at baseline. We employed a backward model selection to remove one non-significant ( | PMC10029790 |
Discussion | obesity, weight gain | OBESITY, CHILDHOOD OBESITY | ¡Míranos! targeted low-income Latino children’s healthy EBRBs with evidence-based Head Start center policies and staff practices, and culturally tailored strategies for parental engagement [These findings are consistent with the conclusions of a recent systematic review [Family-focused interventions are efficacious in the prevention and management of childhood obesity in primary care settings [Inadequate fruit and vegetable intake and excessive intake of added sugar are consistently documented in US children, including preschool-aged children. Approximately one-third of children aged 2–5 do not meet the fruit recommendation and 90–98% do not meet the vegetable recommendation [Sugar intake in children is associated with excessive weight gain. Children aged 1–5 years old reported having intakes of added sugar per day of greater than 10% of daily total kilocalories from sugar [Shorter sleep duration in preschool-aged children is associated with a risk of overweight/obesity [Reducing screen time by 17 min per day in children under age 5 has been achieved through interventions in non-center settings [However, the muted impact on screen time and sleep during the weekend days demonstrates unmet challenges in families from low socioeconomic status and racial/ethnic minorities [The lack of robust Future research should test the feasibility if an equity-based approach to obesity prevention would address the root causes of obesity by providing population-specific interventions (i.e., removing financial barriers) aimed at ensuring all families have a fair and just opportunity to engage in PA and healthy eating practices [A major strength of The limitations of this study include participant parent-reported behaviors at home and the use of a dietary screener to collect dietary data. Measures of parent-reported behaviors at home including screen-time, sleep, and adult facilitated physical activity have been used in previous studies but not validated. Dietary screeners are short food frequency questionnaires designed to capture general dietary information aimed to the reduce respondent burden but limit the utility and interpretation of the dietary data. Dietary data are typically underreported, but some studies show that it can depend on the type of foods reported, with overreporting of | PMC10029790 |
Acknowledgements | The authors would like to thank all the Head Start personnel, parents, and children for agreeing to participate in this study, without whose involvement in this research would not have been possible. | PMC10029790 | ||
Authors’ contributions | ZY and DPM conceptualized the study, secured funding, and administered the study. ZY, DPM, JH, EMVC, EV, ES, SL, and SLU contributed to the acquisition, analysis, and/or interpretation of data. SLU, EMVC, and VE conducted data quality control. YL conducted the primary statistical analysis and drafted tables; SLU and ZY drafted first draft; all authors contributed to the manuscript. All authors read and approved the final manuscript. | PMC10029790 | ||
Funding | Digestive, Diabetes | KIDNEY DISEASES, DIABETES | Funding for this study was provided by the United States National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases (R01DK109323). The sponsors had no role in the design, execution, interpretation, or writing of the study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. | PMC10029790 |
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10029790 | ||
Declarations | PMC10029790 | |||
Ethics approval and consent to participate | This study was approved by the UTSA Institutional Review Board (IRB# 18–187) and parental informed consent was obtained. | PMC10029790 | ||
Consent for publication | Not applicable | PMC10029790 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10029790 | ||
References | PMC10029790 | |||
1. Introduction | end-stage osteoarthritis, osteoarthritis, proprioceptive sensory increase, pain, knee arthroplasty, TKA | OSTEOARTHRITIS | Total knee arthroplasty (TKA) is an effective treatment for end-stage osteoarthritis. However, evidence of combined kinematic chain exercise (CCE) in early-phase rehabilitation after TKA remains lacking. This study investigated the effects of CCE training on physical function, balance ability, and gait in 40 patients who underwent TKA. Participants were randomly assigned to the CCE (Total knee arthroplasty (TKA) is performed to reduce pain and improve physical function and quality of life when daily life is threatened by severe osteoarthritis [Both primary and revised TKA procedures are expected to increase globally with the increasing population of older adults [Currently, rehabilitation exercises for patients who have undergone TKA include balance, proprioceptive sensory increase, preoperative open-kinetic chain (OKCE), and close-kinetic chain exercises (CKCE), which help improve strength, physical function, balance, and walking ability [In early-phase rehabilitation after TKA, postoperative exercise generally involves OKCE, including continuous passive motion (CPM), which improves strength and ROM and can provide a minimal load to the operated joint [Despite the advantages of CCE in knee rehabilitation, limited studies have evaluated the performance of applying CCE to early-phase patients after TKA, and studies verifying the effects of CCE on physical function, balance ability, and gait are insufficient [ | PMC9961064 |
2. Materials and Methods | PMC9961064 | |||
2.1. Participants | spine disease, nervous disease | RHEUMATOID ARTHRITIS, SPINE DISEASE, INFLAMMATORY DISEASE, DEGENERATIVE ARTHRITIS | This study enrolled 40 women who underwent TKA at an orthopedic surgery hospital. The inclusion criteria were as follows: older patients aged >65 years who could communicate with medical staff, those who underwent TKA owing to degenerative arthritis, and those with cemented TKA. The exclusion criteria were as follows: older patients aged >75 years; those with a history of knee joint surgery before TKA; those who possibly had a systematic inflammatory disease such as rheumatoid arthritis; those who had difficulty walking independently; those who had psychological problems or nervous disease; those who had previously received surgery for spine disease ( | PMC9961064 |
2.2. Ethical Statement | The purpose and requirements of this study were explained to the participants in detail. Patients could withdraw their consent to participate in the study at any time during the experimental procedure. Written informed consent was obtained from all patients. This study was approved by the Sahmyook University Institutional Review Board (approval number: 2-7001793-AB-N-012019064HR) and the Clinical Research Information Service (KCT0005823). Participants’ rights were protected according to the ethical principles of the Declaration of Helsinki. | PMC9961064 | ||
2.3. Study Design | This study had a single-blind, randomized controlled trial design. The assessors and participants were blinded to the grouping of each participant. Five physical therapists with more than 5 years of musculoskeletal field experience participated in the study procedures. The assessors were trained on equipment usage and measurement methods for 1 h twice a week before evaluating the participants. All evaluations and exercise training were conducted individually. G*Power Version 3.1.9.7 (Franz Faul, University Kiel, Germany, 2020) was used to calculate the sample size (two-tailed, effect value: 0.5, significant level α: 0.05, and power: 0.8) of the study. The number of required samples was 34. Considering a drop-out rate of 10–15%, 40 patients were recruited, and all study participants were pretested. To minimize the error related to the experiment, 40 patients were randomly assigned to the CCE and OKCE groups using the Research Randomizer program ( | PMC9961064 | ||
2.4. Study Procedure | osteoarthritis | OSTEOARTHRITIS | The experimental setting was an in-patient acute care unit at an orthopedic surgery hospital. All participants underwent TKA using a minimally invasive quadriceps-sparing technique with a high-flexion mobile prosthesis (Implantcast; GMBH Lüneburger Schanze, Buxtehude, Germany). From the 3rd day after TKA, the CCE and OKCE groups performed the exercise five times a week for 30 min (20 times for 4 weeks). Additionally, CPM was applied on the 1st day after TKA in both groups (once a day for 20 min, five times a week for 4 weeks). The CCE and OKCE groups were subjected to the same treatment conditions and environment. To examine the effect of the exercise program after the experiment, each group was administered the same procedure as the pretest and posttest. The baseline assessment was performed 1 day before the TKA procedure, and the posttest was performed 6 weeks after TKA. The Western Ontario and McMaster universities osteoarthritis (WOMAC), Knee Outcome Survey-Activities of Daily Living (KOS-ADLs), and an electronic goniometer were used to evaluate physical functions, and a Zebris PDM multifunction force measuring plate was used to measure balance ability and gait. The timed up-and-go (TUG) test was performed for dynamic balance ability. | PMC9961064 |
2.5. Intervention | knee brace | The CCK and CKCE groups performed each kinetic chain exercise starting on the 3rd day after TKA, and the participants each wore a knee brace and used a walker. The exercise program was based on that outlined in a previous study and was performed each week, considering each patient’s level of performance. | PMC9961064 | |
2.5.1. Combined Kinetic Chain Exercise Program | hip abduction | In the 1st week of training, two sets of 10 repetitions (reps) were performed: quadriceps setting in the supine position, ankle full exercise in the supine position, wall slide, getting up and down from a chair, and standing up and off heels. For the 2nd to 3rd week of training, two sets of 10 reps were performed, including quadriceps setting while sitting, getting up and down from a chair, standing up and off heels, stepping up and down from a step box forward and sideward, and wall squatting. In the 4th week of training, getting up and down from a chair, stepping up and down from a step box forward and sidewards, hip abduction exercise while standing, and mini squats with a walker were performed in two sets of 10 reps for each movement, and two sets of one rep of toe gait were performed for 1 min [ | PMC9961064 | |
2.5.2. Open Kinetic Chain Exercise Program | hip abduction | In the 1st to 2nd week, the training program consisted of knee ROM exercises, quadriceps setting exercises by placing a foam roller under the knee in a supine position, straight leg raising, and ankle pull exercises in the supine position. In the 3rd to 4th weeks of training, ROM exercise of the knee, quadriceps setting in a sitting position, and hip abduction exercises while standing up were performed [ | PMC9961064 | |
2.6. Outcome Measurements | PMC9961064 | |||
2.6.1. Physical Function | knee arthritis, pain | KNEE ARTHRITIS | The WOMAC, ROM, and KOS-ADLs were used to measure the physical function in this study.The WOMAC, which is widely used in patients with knee arthritis (intraclass correlation coefficient, ICC = 0.92), consists of 24 subjective questions about knee joint pain and functional limitations that can be felt daily [Goniometer Biometrics (USA, 2008) was used to measure the flexion ROM of the knee joint (ICC = 0.99) [The KOS-ADL was used to evaluate knee joint function in daily life. The symptoms included six items of influence on general daily living ability. The knee joint condition has 8 (of the total 14) items that influence the ability to perform functionally specific tasks and represents a reliable scale questionnaire to identify knee joint condition and functional ability for daily living (ICC = 0.97) [ | PMC9961064 |
2.6.2. Balance | Balance ability was measured using a Zebris PDM platform (FDM 1.5, Zebris Medical GmbH, Isny, Germany, 2016), and “Zebris Win FDM” software was used for data collection and analysis. The Zebris PDM multifunction force-measuring plate consisted of a pressure mat (1580 mm in length × 605 mm in width × 21 mm in height; 11,264 sensors per 64 × 176 cm; range 1–120 N/cm | PMC9961064 | ||
2.6.3. Gait | Gait parameters, such as gait velocity, cadence, step length, and stride length, were measured using the Zebris PDM platform. The TUG test was used to measure functional mobility [ | PMC9961064 | ||
2.7. Statistical Analysis | All tasks and statistics used in the analysis were based on SPSS ver. 22.0, which was used to calculate the means and standard deviations. All participants were normally distributed using the Shapiro–Wilk normality test. Descriptive statistics were used for the general characteristics of the participants. An independent sample | PMC9961064 | ||
3. Results | osteoarthritis, TKA | OSTEOARTHRITIS | A total of 71 patients were assessed for eligibility, and among them, 40 participants were randomized to complete the study intervention. All participants were women, and all had Kellgren–Lawrence grade 3–4 osteoarthritis before TKA. The demographic characteristics of the 40 patients who underwent TKA at baseline are shown in | PMC9961064 |
3.1. Primary Outcomes | The physical function values are listed in | PMC9961064 | ||
4. Discussion | This study found that the 4-week CCE program improved physical function, balance ability, and gait in early-phase patients after TKA. | PMC9961064 | ||
4.1. Effects of Physical Function | muscular atrophy, neuromuscular defects, ’ quadriceps femoris, pain, TKA | MUSCULAR ATROPHY | TKA relieves pain and improves physical function while decreasing functional movement abilities, such as climbing up and down stairs and walking. After surgery, the patients’ quadriceps femoris and hamstrings are weakened, which leads to the occurrence of muscular atrophy and neuromuscular defects [Olagbegi OM et al. [ | PMC9961064 |
4.2. Effects of Balance | bodily dysfunction, TKA | The patients who underwent TKA complained of discomfort due to incomplete bodily dysfunction. Muscle strengthening exercises, such as kinetic chain exercises, can improve balance by boosting the strength and thickness of the knee extensor muscles ( | PMC9961064 | |
4.3. Effects of Gait | pain | After TKA, the patients experienced a decreased frequency of step length owing to slow gait speed and a decreased knee joint flexion angle during the stance and swing phases. Smith et al. [Ouellet and Moffet [This study had several limitations. We evaluated the short-term effect of CCE after 4 weeks of intervention. However, the long-term effects could not be determined owing to a lack of follow-up. Moreover, as the participants (only women) were recruited from specific countries and regions, the results cannot represent all patients who underwent TKA. Additionally, we could not control the drugs and injections used for pain control in the in-patient unit. Therefore, in a future study, considering these limitations, a long-term exercise plan should be implemented for all patients who underwent TKA, and it should be confirmed whether the impact of CCE is effective throughout the follow-up. Additional studies are needed to provide evidence to support CCE training in patients who underwent TKA. | PMC9961064 | |
Author Contributions | J.A. and Y.-W.S. equally contributed to this study; conceptualization, J.A., Y.-W.S. and B.-H.L.; data curation, J.A. and Y.-W.S.; formal analysis, J.A. and Y.-W.S.; methodology, J.A. and Y.-W.S.; writing—original draft, J.A. and Y.-W.S.; project administration, B.-H.L.; supervision, B.-H.L.; writing—reviewing editing, J.A., Y.-W.S. and B.-H.L. All authors have read and agreed to the published version of the manuscript. | PMC9961064 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of the Sahmyook University (approval number: 2-7001793-AB-N-012019064HR) in the Republic of Korea. The protocol of this trial was retrospectively registered in the Clinical Research Information Service of the Republic of Korea (KCT0005823). | PMC9961064 | ||
Informed Consent Statement | Informed consent was obtained from all the participants involved in the study. | PMC9961064 | ||
Data Availability Statement | Not applicable. | PMC9961064 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9961064 | ||
Abbreviations | knee arthroplasty | OSTEOARTHRITIS | BMI: body mass index; CAV: center of pressure average velocity; CCE: combined kinetic chain exercise; CEA: confidence ellipse area; CKCE: close-kinetic chain exercises; CPL: center of pressure path length; CPM: continuous passive motion; KOD-ADLs: Knee Outcome Survey-Activities of Daily Living; MCID: minimal clinically important difference; OKCE: open kinetic chain exercise; ROM: range of motion; TKA: total knee arthroplasty; TUG: timed up-and-go; WOMAC: The Western Ontario and McMaster Universities Osteoarthritis Index. | PMC9961064 |
References | Osteoarthritis, abduction | OSTEOARTHRITIS | Flow diagram of the total experiment. CCE: combined kinetic chain exercise; OKCE: open kinetic chain exercise; WOMAC: the Western Ontario and McMaster Universities Osteoarthritis Index; ROM: knee range of motion; KOD-ADLs: Knee Outcome Survey-Activities of Daily Living.Combined kinetic chain exercise program.Quadriceps setting in the supine positionAnkle full exercise in a supineWall slideGetting up and down from a chairStanding up and off heelsQuadriceps setting while sittingGetting up and down from a chairStanding up and off heelsWall squatStepping up and down the step box forward and sidewardGetting up and down from a chairHip abduction exercise while standingStepping up and down from a step box forward and sidewardMini squat with a walkerToe gaitOpen kinetic chain exercise program.Knee range of motion exerciseQuadriceps setting in a supine position with a foam roller under the kneesStraight leg-raisingAnkle full exercise in a supine positionKnee range of motion exerciseAnkle full exercise in a supine positionQuadriceps setting in a sitting positionHip abduction exercise in a standing positionDemographic characteristics (CCE: combined kinetic chain exercise; OKCE: open kinetic chain exercise; BMI: body mass index. Values are expressed as the mean ± standard deviation. Significant: Comparisons of physical function.CCE: combined kinetic chain exercise; OKCE: open kinetic chain exercise; WOMAC: the Western Ontario and McMaster Universities Osteoarthritis Index; ROM: knee range of motion; KOD-ADLs: Knee Outcome Survey-Activities of Daily Living. Values are expressed as the mean ± standard deviation. 95% CI: 95% confidence interval; significant: Comparisons of balance parameters.CCE: combined kinetic chain exercise; OKCE: open kinetic chain exercise; CEA: confidence ellipse area; CPL: center of pressure path length; CAV: center of pressure average velocity. Values are expressed as the mean ± standard deviation; 95% CI: 95% confidence interval; significant: Comparisons of gait parameters.CCE: combined kinetic chain exercise; OKCE: open kinetic chain exercise; TUG: timed up-and-go. Values are expressed as mean ± standard deviation; 95% CI: 95% confidence interval; significant: | PMC9961064 |
Abstract | PMC10587928 | |||
Introduction | cancer, toxic | CANCER, SECONDARY, PERIPHERAL NEUROPATHY, SIDE EFFECT | Vincristine is an integral component of treatment for children with cancer. Its main dose‐limiting side effect is vincristine‐induced peripheral neuropathy (VIPN). The VINCA trial was a randomized controlled trial that explored the effect of 1‐hour infusion compared with push injection of vincristine on the development of VIPN in children with cancer. The short‐term outcomes (median follow‐up 9 months) showed that there was no difference in VIPN between the randomization groups. However, 1‐hour infusion was less toxic in children who also received azoles. We now report the results of the final analyses (median follow‐up 20 months), which includes treatment outcome as a secondary objective (follow‐up 3 years). | PMC10587928 |
Methods | neuropathy | ADVERSE EVENT, NEUROPATHY | VIPN was measured 1–7 times per participant using the Common Terminology Criteria for Adverse Events (CTCAE) and the pediatric‐modified total neuropathy score. Poisson mixed model and logistic generalized estimating equation analysis for repeated measures were performed. | PMC10587928 |
Results | Forty‐five participants per randomization group were included. There was no significant effect of 1‐hour infusion compared with push injection on VIPN. In participants receiving concurrent azoles, the total CTCAE score was significantly lower in the one‐hour group (rate ratio 0.52, 95% confidence interval 0.33–0.80, | PMC10587928 | ||
Conclusion | cancer, Gertjan J.L. | CANCER, PERIPHERAL NEUROPATHY, SIDE EFFECT | 1‐hour infusion of vincristine is not protective against VIPN. However, in patients receiving concurrent azoles, 1‐hour infusion may be less toxic. The difference in treatment outcome is most likely the result of differences in risk profile.Vincristine is an integral component of treatment for children with cancer. Its main dose‐limiting side effect is vincristine‐induced peripheral neuropathy (VIPN). The VINCA trial was a randomized controlled trial that explored the effect of one‐hour infusion compared with push injection of vincristine on the development of VIPN in children with cancer. We found that in patients receiving concurrent azoles, one‐hour infusion may be less toxic.
Gertjan J.L. Kaspers and Mirjam Esther van de Velde shared last authorship. | PMC10587928 |
INTRODUCTION | cancer, pain, ALL | NEPHROBLASTOMA, CHILDHOOD CANCER, CANCER, ACUTE LYMPHOBLASTIC LEUKEMIA, SECONDARY, LYMPHOMA | Vincristine is a chemotherapeutic agent that is frequently used in childhood cancer treatment protocols, such as those for acute lymphoblastic leukemia (ALL), lymphoma, and nephroblastoma.Severe VIPN is estimated to affect up to 30% of patients, but it remains a challenge to predict which patients are at risk.The treatment options for VIPN are limited to pain medication and reducing vincristine dosage.The VINCA trial is a randomized controlled trial (RCT) on the effect of 1‐hour infusion compared with push injection on VIPN in children with cancer. In the first report of the VINCA trial (median follow‐up 9 months), we found no effect of administration duration of vincristine on VIPN. However, in participants receiving concurrent azoles, 1‐hour infusion resulted in less VIPN compared with push injection. In this final follow‐up study (median follow‐up 20 months), we assess the long‐term effect of vincristine administration duration on the development of VIPN. As a secondary objective, we assessed the effect on treatment outcome (follow‐up 3 years). | PMC10587928 |
METHODS | PMC10587928 | |||
Patients | The design and methods of the VINCA trial were published previously. | PMC10587928 | ||
Assessment of | VIPN was assessed using the CTCAE, version 4.03 | PMC10587928 | ||
Sample size calculation | The sample size calculation was based on total CTCAE scores. | PMC10587928 | ||
Statistical analysis | The statistical analysis was performed in R, version 4.0.3 (Rstudio Inc.). | PMC10587928 | ||
RESULTS | PMC10587928 | |||
Participant characteristics | ALL | ACUTE LYMPHOBLASTIC LEUKEMIA | Figure Flow diagram of the participants, including the number of measurements in the first analysis of the VINCA trial and the extended follow‐up study. The full flow diagram of the screening, randomization, and follow‐up of the VINCA study can be found in the first analysis of the VINCA trial.Characteristics of participants in the randomization groups (push‐ and one‐hour administration of vincristine).Abbreviations: ALL, acute lymphoblastic leukemia; BSA, body surface area; SD, standard deviation. | PMC10587928 |
CTCAE | peripheral neuropathy, Neuropathy, neuropathy | ADVERSE EVENTS, PERIPHERAL NEUROPATHY, NEUROPATHY, NEUROPATHY | According to the CTCAE, 57.8 and 55.6% of the push and one‐hour group developed VIPN, of which 15.6 and 13.3% developed severe VIPN, respectively (Grade 3 or higher) (Table Incidence of vincristine‐induced peripheral neuropathy of participants in the randomization groups (push‐ and one‐hour administration of vincristine).Total group consisted of 70 participants (push group: 33, one‐hour group: 37)Total group consisted of 59 participants (push group: 28, one‐hour group: 31)Total group consisted of 11 participants (push group: 5, one‐hour group: 6).Abbreviations: CTCAE, common terminology of adverse events; IQR, interquartile range; ped‐mTNS, pediatric‐modified Total Neuropathy Score; VIPN, vincristine‐induced peripheral neuropathy.The effect of one‐hour administration in comparison with push administration of vincristine on the development of vincristine‐induced peripheral neuropathy over time.
Total group consisted of 60 participants (without concurrent azole antifungals: 49, with concurrent azole antifungals: 11).Abbreviations: CI, confidence interval; CTCAE, common terminology criteria for adverse events; OR, odds ratio; ped‐mTNS, pediatric modified total neuropathy score; VIPN, vincristine‐induced peripheral neuropathy.Estimated total CTCAE score over time in the randomization groups including 95% confidence interval (corrected for baseline). Median days and IQR per measurement moment are as follows: measurement 1: push = 29 (27; 42) and one‐hour = 28 (25; 47), measurement 2: push = 163 (129; 218) and one‐hour = 167 (99.5; 208), measurement 3: push = 403 (276; 518) and one‐hour = 387 (228; 466), measurement 4: push = 638 (529; 715) and one‐hour = 644 (410.5; 666), measurement 5: push = 915 (679.3; 957) and one‐hour = 884 (500; 953), and measurement 6: push = 868 (625.3; 895) and one‐hour = 469 (426.5–827). For the number of participants per measurement moment: see Figure Age, sex, diagnosis, and racial background were not identified as modifiers in the relationship between VIPN according to CTCAE and randomization group. However, concurrent azoles was identified as a modifier in this relationship (Estimated total CTCAE score over time in the randomization groups per concurrent azoles, including 95% confidence interval. Number of participants analyzed per group are as follows: push administration: No significant difference was found between the randomization groups all VIPN measurements during vincristine treatment and ≥6 months after last vincristine administration were compared (Figure The results were similar in the per protocol analyses (data not shown). | PMC10587928 |
Ped‐mTNS | In the 70 participants of whom ped‐mTNS data were available (≥5 years old and 35 in each randomization group), respectively, 72.7 and 64.9% in the push and one‐hour groups developed VIPN. The median number of follow‐up measurements was four in the push group (IQR 2.25–4.75) and three in the one‐hour group (IQR 1.5–5). The development of VIPN over time according to the ped‐mTNS was not significantly different between the randomization groups, both in the crude and adjusted analyses (Table Age, sex, concurrent azoles, diagnosis, and racial background were not identified as modifiers in the relationship between VIPN according to ped‐mTNS and randomization group.The results were similar in the per protocol analyses (data not shown). | PMC10587928 | ||
Treatment efficacy | malignant rhaboid tumor | WILMS TUMOR, LYMPH NODE METASTASES, RHABDOMYOSARCOMA | At 3‐year follow‐up, one participant in the push group and six participants in the one‐hour group had an adverse treatment outcome (Table Characteristics of participants with an adverse treatment outcome.Abbreviations: EFS, event‐free survival; HR, high risk; N.A, not applicable; RMS, rhabdomyosarcoma; VHR, very high risk.After initial diagnosis with a Wilms tumor, the participant received a different diagnosis during treatment (malignant rhaboid tumor of the kidney with pulmonary and lymph node metastases) and was subsequently excluded from the study. All vincristine administrations were given as 1‐hour infusion. | PMC10587928 |
DISCUSSION | toxicity, cancer, toxic, PK/PD, weakness | CANCER, DISEASE | In this final analysis study, we assessed the long‐term effect of one‐hour administration of vincristine compared with push administration on the development of VIPN. We found that 1‐hour infusion of vincristine did not protect against VIPN compared with push injection, both during and 6 months after vincristine treatment. In an exploratory subgroup analysis, we found that one‐hour administration resulted was less toxic in children receiving concurrent azoles. More patients relapsed in the one‐hour group than in the push group, but this was most likely due to differences in disease risk profile.Although in previous studies multi‐day infusions with dosages up to 3.5–4.0 mg/mIn participants receiving concurrent azoles, one‐hour administration of vincristine resulted in less VIPN compared with push administration: the push group had a twice as high chance of having one point higher on the CTCAE scale. We confirmed this finding from the previously published study.We observed that more participants in the one‐hour group relapsed than in the push group. However, the number of participants with a high risk disease profile was higher in the one‐hour group than in the push group. Furthermore, we do not consider it biologically plausible that 1‐hour infusion of vincristine results in less overshoot of vincristine in the blood and thus lower therapeutic efficacy. All in all, we argue that it is unlikely that the duration of vincristine administration is the cause of the observed difference in treatment outcome between the push and one‐hour group.The results of this final analysis confirms those of the previously published one‐year analysis.The strength of this study is that we performed longitudinal VIPN assessments using sensitive measurement tools. We assessed the effect of administration duration on VIPN during and after treatment. A weakness of this study is that the study was not adequately powered to detect a difference in treatment outcome, which may hamper the interpretation of the clinical significance of the study. Another weakness of this study is that measurements were performed at different time points after a varying number of vincristine administrations. Since the timing of VIPN assessment in relation to the number and time of vincristine administrations affects VIPN, this likely influenced the results. We corrected for cumulative vincristine dosage and intra‐individual variability, but in this analysis, it was not possible to include the time between VIPN assessment and vincristine administrations. We are planning to investigate this in a follow‐up pharmacokinetic–pharmacodynamic (PK/PD) study. In addition, a median follow‐up of 20 months is relatively short to assess the long‐term effect of randomization on VIPN. However, studies have shown that there is little additional recovery from VIPN as the interval following vincristine administration increases.The VINCA trial assessed the effect of 1‐hour infusion of vincristine in comparison with push injection on the development of VIPN in children with cancer. We found that there was no long‐term effect of administration duration on VIPN. However, in participants receiving concurrent azoles, one‐hour administration was less toxic compared to push administration, suggesting that some children may benefit from one‐hour vincristine administrations. Future studies should aim to clarify the relationship between the PK and PDs of vincristine, including toxicity and efficacy. This will contribute to precision treatment of vincristine in children with cancer. | PMC10587928 |
AUTHOR CONTRIBUTIONS | PMC10587928 | |||
FUNDING INFORMATION | This research was funded by the Netherlands Organization for Health and Development (pro‐gram Proper Use of Medication; 836021006) and the Belgian Health Care Knowledge Centre (16015). | PMC10587928 | ||
CONFLICT OF INTEREST STATEMENT | The authors declare no conflicts of interest. | PMC10587928 | ||
ETHICS APPROVAL STATEMENT | Ethical approval was obtained before initiation of this study (Institutional Review Board (IRB) of Amsterdam UMC, location VUmc (IRB number: 2014–268). | PMC10587928 | ||
PATIENT CONSENT STATEMENT | Patient consent was obtained from all participants of this study. | PMC10587928 | ||
CLINICAL TRIAL REGISTRATION | This clinical trial was registered at EUDRACT (EUDRACT number: 2014–001561‐27). | PMC10587928 | ||
Supporting information |
Data S1.
Click here for additional data file. | PMC10587928 | ||
ACKNOWLEDGMENTS | The authors acknowledge D.C. Wijnker for his technical assistance in performing the statistical analyses. | PMC10587928 | ||
DATA AVAILABILITY STATEMENT | Data is available upon reasonable request. | PMC10587928 | ||
REFERENCES | PMC10587928 | |||
Abstract | PMC10009422 | |||
Aim | PMS | This study aimed to compare the effect of peer education and education provided by healthcare providers on PMS in high school students. | PMC10009422 | |
Materials and Methods | This quasi‐experimental non‐randomized controlled trial with a three‐armed parallel design was performed on 90 students allocated in three groups, namely, education by peer (intervention group 1 = 30), education by a healthcare provider (intervention group 2 = 30), and a control group ( | PMC10009422 | ||
Results | Education in intervention group 1 (Partial Eta Squared = 0.67, | PMC10009422 | ||
Conclusion | PMS | PMS | This study suggests education by peers and healthcare providers effects on PMS and general health in adolescents. It suggested that the effectiveness of these approaches be investigated in other adolescents' health conditions.This study was conducted in two stages. The first step involved identifying students with moderate to severe PMS using Premenstrual Symptoms Screening Tool. Then, 96 eligible students, who were willing to participate in the study, entered the second stage of the study. Among them, six students from a school were selected as peer educators, and 30 students from the same school were included in the intervention groups. From the rest of the eligible students, 30 were randomly selected as the second intervention group and 30 students as the control group.
| PMC10009422 |
INTRODUCTION | DISORDER, PMS | Adolescence is one of the most valuable periods of one's life and the beginning of physical, psychological, and social changes that affect the performance of individuals in adulthood.Symptoms of this disorder periodically appear as a combination of physical, psychological, and behavioral changes in the luteal phase of the menstrual cycle and can lead to disruption in a person's daily activities.Existing literature has shown that the prevalence of PMS is between 40% and 80% in the world. | PMC10009422 | |
METHOD | PMC10009422 | |||
Design and study setting | The trial protocol is reported elsewhere. | PMC10009422 | ||
Sample size | The pilot method was used to determine the volume of the study. Analysis of the information obtained from half of the participants, 45 students (15 students in each group) participating in the study. According to the Confidence Coefficient: 95%, Power: 80%, Effect Size (ES) = 0.8, and by considering an attrition rate of 25%, the sample size in each group was calculated, 30 students as follows: | PMC10009422 | ||
Inclusion and exclusion criteria | cancer, death, traumatic | IRRITABLE BOWEL SYNDROME, CHRONIC ILLNESSES, COAGULATION DISORDERS, PMS, CANCER, EVENTS | The 11th‐grade single students with regular menstruation (interval of 21–35 days) and moderate to severe PMS were enrolled. The exclusion criteria encompassed students with chronic illnesses (such as irritable bowel syndrome, coagulation disorders, and cancer), professional athletes, and students who used alternative therapies such as traditional medicine to control the PMS symptoms. Moreover, those who took hormonal treatments (e.g., estrogen, progesterone, their compounds, or antidepressants) and those who have experienced traumatic events, such as severe accidents, the death of family members (father, mother, siblings), and parental divorce over the past 6 months were excluded. | PMC10009422 |
Outcomes | PMDD | SECONDARY, PMS | The primary outcome was a change in the PMS score in the intervention groups compared to the control group. Besides, changes in general health scores and the frequency of PMDD were considered secondary outcomes. | PMC10009422 |
Recruitment | PMS | PMS | This study was conducted in two stages from December 2020 to September 2021 in Sari, northern Iran. The first step involved identifying students with moderate to severe PMS using Premenstrual Symptoms Screening Tool. By referring to six purposefully selected schools in Sari (among the 14 high schools), the census sampling method was employed to assess the PMS severity of 504 students. At this stage, 408 students were excluded from the study (405 students not meeting inclusion criteria and three students declined to participate). Then, 96 eligible students, who were willing to participate in the study, entered the second stage of the study. Among them, six students of a school with better power of speech and good communication skills (according to the school counselor and principal's viewpoint) were selected as peer educators, and 30 students from the same school were included in the first intervention group (education by peers). From the rest of the eligible students, with the assistance of a random number table, 30 students were selected as the second intervention group (education by a healthcare provider) and 30 students as the control group. In the follow‐up phase, no samples were lost in the groups. | PMC10009422 |
Measurements | PMC10009422 | |||
Daily record of severity of problems (DRSP) | PMS | This questionnaire prospectively evaluates 30 PMS symptoms according to DSM‐V criteria in the form of physical, psychological, and social symptoms on a 4‐point Likert scale from 0 to 3. The scores range from 0 to 90, and a higher score indicates greater severity of PMS. | PMC10009422 | |
Premenstrual symptoms screening tool (PSST) | PMS | PMS | This 19‐question tool with two domains retrospectively examines the severity of PMS symptoms. The first domain includes 14 items related to psychological, physical, and behavioral symptoms, and the second domain (five items) measures the effect of these symptoms on the individual's life. Each question is rated on a 4‐point scale, i.e., not at all, mild, moderate, and severe, ranging from 0 to 3. To determine the mild to severe PMS, the researchers must simultaneously meet the following three conditions: there should be at least one item with moderate to severe from items 1 to 4, at least four items with moderate to severe from items 1 to 14, and one item in the second domain must be mild or severe. In addition, this instrument is used to screen the PMDD. It requires the following three conditions to be simultaneously detected: at least one severe item from items 1 to 4, at least four moderate or severe items from items 1 to 14, and at least one severe item in the last five items. | PMC10009422 |
Goldberg general health questionnaire (GHQ) | This well‐known valid 28‐question instrument with four subscales is scored from 0 to 3 on the Likert scale. Scores range from zero to 84, and lower scores indicate better mental health. | PMC10009422 | ||
Intervention | COMPLICATIONS, PMS | At first, the first researcher (a Master of Science midwifery student who worked under the supervision of the research team, i.e., a reproductive health professor and a psychiatrist) trained the six peer educators in person for six 60‐minute sessions (two sessions per week). The educational content included the anatomy and physiology of the female reproductive system, normal menstruation, related factors to PMS, its complications, and ways to manage it. Also, education about issues such as life skills, problem‐solving, critical thinking, decision‐making skills, creative thinking, and communication was provided. Then, the peer educators and a healthcare provider simultaneously provided their education for the intervention group 1 (30 students in three groups of 10) and intervention group 2 (a group of 30), respectively. In each group of 10, two trained students as peer educators led the sessions. The intervention was held in six 60‐minute sessions twice a week in WhatsApp messenger. The research team developed the content of the education sessions using the available resources. The protocol content as presented in Table The content of training sessions in the intervention groups | PMC10009422 | |
Data analysis | The collected data were fed into SPSS version 18. Numerical variables were reported as mean and standard deviation, and categorical variables were presented as frequency and percentage. ANCOVA assessed the mean difference between the intervention and control groups in the primary outcome with repeated measures; the post‐hoc Bonferroni test controlled the increased risk of type I error due to multiple comparisons and compared the pairs with repeated‐measures tests with significant results. An independent | PMC10009422 | ||
RESULTS | All 30 participants in each group completed the study and entered the analysis stage. The flow diagram of the study is presented in Figure Flow diagram of the studyParticipants' socio‐demographic characteristicsPresented as mean ± SD.Presented as number (frequency). | PMC10009422 | ||
Primary outcome: Premenstrual syndrome | PMS | As shown in Table Means and standard deviations of PMS score at the baseline and after the interventionEffect sizeconfidence interval0.67(1.0–27.11)0.82(1.0–37.23) | PMC10009422 | |
Secondary outcomes: General health and premenstrual dysphoric disorder | Results (Table Mean score and standard deviation of general health score, at the baseline, and after the interventionEffect sizeconfidence interval0.25(0.81–0.31)0.37(0.93–0.19) | PMC10009422 | ||
DISCUSSION | PMS | The present study compared peer education and healthcare provider education regarding PMS in adolescents. The study illustrates that education in both intervention groups significantly reduced the PMS score compared to the control group. Similarly, several studies have shown that educational approaches can manage PMS symptoms.In contrast to the present study, Sehati et al.The results of this study illustrate that the participants in the second intervention group which education provided by healthcare provider had lower mean PMS scores than peer education. Accordingly, Azizi et al.The results of the present study demonstrate that education significantly improved the general health of both intervention groups compared to the control group. In line of our study, some studies showed that health education by peers influences psychological, physical, and overall quality of life dimensions of adolescents. | PMC10009422 | |
STRENGTHS AND LIMITATIONS | tiredness, blindness | BLINDNESS | One of the strengths of this study is that standard and valid questionnaires were used in this study, and the psychometric properties of these questionnaires have been assessed in Iran already.Nonetheless, these results must be interpreted with caution, and a number of limitations should be borne in mind. Despite the non‐randomized sampling and potential selection bias, the study variables were not statistically different in the three groups at the beginning of the study. Randomized design with more samples in the future may provide more consistent evidence in this issue. Another limitation was the lack of blindness of the intervention; there is a possibility of performance bias. The other limitation of this project was that the questionnaires were self‐reports, so individual differences, tiredness, and boredom were the factors that could affect their responses. Therefore, the researcher emphasized the confidentiality of the information and explained the importance of their responses to decrease the error resulting from this limitation. Finally, that the participants may have had online searches and used other resources is another limitation of this study. | PMC10009422 |
CONCLUSION | PMS | The study reveals that peer education can positively affect the PMS and general health in adolescent girls. It seems that applying this cost‐effective educational approach in schools and health centers can be an efficient step in promoting the health of adolescent girls and improving the quality of schools' health education programs. Finally, the results recommend that health policymakers with the participation of the education organization can act by using midwifery consultants as peer trainers. Although this study focused on PMS relief, this strategy is generally health promoting and can be applied to other adolescents' health conditions. | PMC10009422 | |
AUTHOR CONTRIBUTIONS | All authors conceptualized and designed the study. Data were collected by FB and ZS. FB, ZS, and JYC performed the statistical analyses. ZS, FB, FE, MHT, and JYC collaborated in the interpretation of the results. ZS drafted the manuscript. ZS, FB, and MHT wrote the final version of the manuscript and revised it critically for important intellectual content. All authors read and approved the final manuscript. | PMC10009422 | ||
FUNDING INFORMATION | This project was fully supported and funded by Mazandaran University of Medical Sciences and the Student Research Committee of Mazandaran University of Medical Sciences, Grant number: 9188. | PMC10009422 | ||
CONFLICT OF INTEREST | The authors declare that they have no competing interests. | PMC10009422 | ||
ETHICAL APPROVAL | PMC10009422 |
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