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Material and Methods | swelling, incisors, Trismus, pain, trismus | SYSTEMIC DISEASE, IMPACTED MOLARS, POSTOPERATIVE COMPLICATIONS, TRISMUS, FACIAL SWELLING, DRY SOCKET, TRISMUS, COMPLICATIONS | - Study design and sampleThis randomized, prospective, three-arm clinical study consisted of patients who presented to the Department of Oral and Maxillofacial Surgery for surgical removal of a bilaterally impacted mandibular third molar from October 2021 to April 2022. Patients participated voluntarily and signed an informed consent form as well as understood and complied with the research scheme. The study protocol was reviewed and approved by the Ethics Committee of the Stomatological Hospital, Southern Medical University, Guangzhou. All procedures performed in studies involving human participants were in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The objective of the procedure was explained during the first appointment. All the patients were informed of the potential complications and benefits. All patients were treated by the same surgeon (G.J.Y), a specialist with more than 10 years of experience in oral and maxillofacial surgery. The reporting of the methodology used in this study conforms with the CONSORT Statement (- Inclusion and exclusion criteriaThe Winter and Pell and Gregory classifications were used to evaluate the inclusion and exclusion criteria. The molars were horizontally/mesio-angularly impacted, and all teeth were partially or completely covered by mucosa. The region, size, and resistance distribution of the impacted molars were similar as seen on panoramic radiographs. Patients with any systemic disease, poor oral hygiene, age < 18, or who failed to attend follow-ups were excluded from this study. Smokers were not excluded from this study, but all the patients were informed not smoke at least two weeks after surgery. Patients with differences in operation time that exceeded 5 minutes were also excluded from the study.- Sample size calculationA priori power analysis was carried out during the planning stage of this experiment to determine the ideal sample size. The ideal sample size was calculated using G* power software version 3.1.9.7 to ensure adequate computing power for the study. To detect a difference between the groups with a two-sided 5% significance level and a power of 80%, a sample size of 84 patients was necessary, and this was increased to 90 patients to compensate for possible losses.- RandomizationA block permuted randomisation was used with variable block size (
CONSORT flow diagram of the patients in the trial.- Surgical procedureThe surgery was carried out with the patients under local anesthesia. The anesthetic used was Articaine in a 4% solution with additional epinephrine in a concentration of 1:100000 (Primacaine, France). All patients were cut with an electric knife (XO Odontosurge4, Denmark). The traditional triangular flap incision was implemented as described by Szmyd
Incision line. (a) Incision line used in this study. (b) Traditional incision line.
Suture method in this study. (a) Airtight suture method. (b) Buccal drainage method. (c) No-suture method.- Postoperative MedicaltionsAll patients in the study routinely received amoxicillin (oral 500 mg every 8 hours) for 3 days after surgery. Chlorhexidine solution (0.12%) was administered 3 times a day for 7 days. Ibuprofen was taken only if required to control post-operative pain and edema.- Postoperative follow-up and measurementAll patient treatment times were recorded (from the first incision to the last suture);the operator and the dental assistant who performed the surgical interventions were not blinded due to the nature of the interventions. One author, who performed all the measurements and was responsible for the calculations and calibrations, was not involved in the selection and intervention of the participants. Postoperative measurements, that included details of pain, trismus, swelling, quality of life, dry socket, and other postoperative complications, were repeated twice and the mean values were recorded. The data collection methods are as follows:All patients were given a 10-cm standard visual analog scale (VAS) form—the scoring ranged from “0” meaning no pain on the left to “10” meaning the worst possible pain on the right. Patients were asked to indicate the point on the scale that best corresponds to their pain on postoperative days 1, 3, and 7. They were also asked to record analgesic requirements for the 7 days after surgery. Trismus was performed by measuring the distance between the mesial-incisal corners of the upper and lower right central incisors at a maximum opening of the jaws for pre-operative and post-operative (after 1, 3, and 7 days) conditions. Facial swelling was determined based on soft tape measurements between the tragus and the soft tissue pogonion, the tragus and the lateral corner of the mouth, the lateral corner of the eye, and the angle of the mandible. Percentages were calculated from the differences between the pre-operative and the 1, 3, and 7 days post-operative measurements. The results were then divided by the value obtained in the pre-operative period and multiplied by 100, as described in Amin Another important measurement was the modified questionnaire on postoperative patient quality of life (QOL) (- Statistical analysisStatistical analysis was performed using the SPSS for Windows version 23.0 (SPSS Inc., Chicago, IL). The Shapiro-Wilk test was performed, and the results were expressed as mean ± standard deviation in order to verify the normal distribution of the data. The statistical differences were performed using the Pearson's chi-squared test, one-way ANOVA, and the Kruskal-Wallis test with Bonferroni post-hoc correction, for data normally distributed and non-normally distributed,. The level of significance was set at | PMC10499349 |
Results | postoperative pain, hematoma, alveolitis, nerve injury | HEMATOMA, ALVEOLITIS, COMPLICATIONS | Demographic characteristics are described in In the comparison between the three groups on the 1st day after surgery, all values were better in the buccal drainage method group than in the airtight suture method and the no-suture method group, but not significantly. Compared to the first day, the buccal drainage method group showed significant postoperative pain decrease and better speech ability than the no-suture method group on the 3rd day, with a mean of 1.3 and 0.7, respectively (One case of alveolitis was also found in the no-suture method group after surgery; however, the patient recovered quickly after the appropriate treatment was administered. None of the patients exhibited any complications such as nerve injury and hematoma, and all patients recovered without any complications from the procedure. No patients discontinued the trial or were lost to follow-up (Fig.
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Comparison of treatment time and pain killer difference between three groups. | PMC10499349 |
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Comparison of VAS and QOL scores difference between three groups. |
Clinical photograph of the surgical area. (a) Airtight suture method, one stitch in the mesio-buccal incision and another stitch in the distal incision. (b) Buccal drainage method, with only one stitch in the distal incision. (c) No-suture method, with no sutures used for closure. (d) Clinical outcomes of the airtight suture method group after 7 days. (e) Clinical outcomes of the buccal drainage method group after 7 days. (f) Clinical outcomes of the no-suture method group after 7 days. | PMC10499349 |
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Discussion | swelling, alveolitis, fibrosis, pain, Dehiscence, trismus | ACUTE INFLAMMATORY RESPONSE, ALVEOLAR OSTEITIS, IMPACTION, ALVEOLITIS, FIBROSIS, SECONDARY, WOUND DEHISCENCE, ABSCESSES, DEHISCENCE, TRISMUS | The alleviation of patient discomfort from pain, swelling, and trismus following an impacted mandibular third molar removal presents a continual challenge to oral surgeons. Thus, there are many kinds of flap designs used while removing an impacted mandibular third molar with the aim of recovering the soft tissues for better healing (In this study, patients were randomized and divided into three groups: the airtight suture group, the buccal drainage group, and the no-suture group. We transferred the drainage channel from the occlusal surface to the buccal surface to decrease food impaction. The primary result of the present study is that the buccal drainage method revealed better postoperative patient satisfaction than the airtight suture method at all measured times. This could be explained by the fact that the acute inflammatory response peaks within 24 hours after the surgery and then decreases gradually (With respect to surgical incision, Shevel The primary limitation of this method is the uncertainty of whether the secondary closure would induce wound dehiscence due to one case of alveolitis in the suture-less group after surgery. Dehiscence creates a potential trap for food particles and is an excellent environment for bacterial growth, thus leading to postoperative alveolar osteitis, soft tissue abscesses, long-term discomfort, and additional treatment requirements. Further comparative studies involving larger populations are required to determine the best flap technique for a third molar surgery. In addition, we don’t have the long-term evaluation results due to the patients usually refused to hospital after the wound healed especially COVID-19 's epidemic period. In conclusion, the buccal drainage method may have more advantageous than the traditional method and no-suture method in terms of pain as well as having a better impact on QOL during the early postoperative period. The triangular flap without buccal sutures may be a simple and viable option for clinical applications, especially for some buccal mucosa tension is difficult to pull, such as mouth opening limitation and buccal mucosal fibrosis.Ackcnowledgements We are particularly grateful to all the people who have given us help on our article.Authors contributions Authors Tong-Yue Wang and Zhi-Ping Wang contributed equally to this study.
Conception and design of the research: Jin-Yuan Guo, Tong-Yue Wang.
Acquisition of data: Zhao-Qiang Zhang, Xiang-Huai Zheng.
Analysis and interpretation of the data: Xiang-Huai Zheng, Yuan Du.
Statistical analysis: Zhao-Qiang Zhang, Yuan Du.
Obtaining financing: Zhi-Ping Wang.
Writing of the manuscript: Tong-Yue Wang, Jin-Yuan Guo.
Critical revision of the manuscript for intellectual content: Zhi-Ping Wang.
All authors read and approved the final draft. All authors contributed equally to this study.Ethics The study was conducted in accordance with the Declaration of Helsinki(as was revised in 2013). The study was approved by Ethics Committee of the Stomatological Hospital, Southern Medical University. Written informed consent was obtained from all participants.(Approval No.[2021]37).
This controlled trial was approved by the Ethics Committee of Stomatological Hospital, Southern Medical University, and registered in the Chinese Clinical Trial Register website (http://www.chictr.org.cn/,ChiCTR2100051076). A written consent was obtained from each patient.Conflicts of interest The authors declare that they have no competing interests.Funding This study was supported by the Key-Area Research and Development Program of Guangdong Province (No.2019B010941002). | PMC10499349 |
Abstract | PMC10501244 |
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Background | LUNG CANCER | ONO‐4538‐52/TASUKI‐52 was performed in Japan, Korea, and Taiwan to determine the oncological effectiveness and safety of combining nivolumab or placebo with bevacizumab plus platinum chemotherapy for the initial (first‐line) treatment of patients with advanced non‐squamous non‐small cell lung cancer (nsNSCLC). At the interim analysis (minimum follow‐up, 7.4 months), the independent radiology review committee‐assessed progression‐free survival was significantly longer in the nivolumab arm, but overall survival (OS) data were immature. | PMC10501244 |
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Methods | treatment‐naïve stage IIIB/IV | Here, we present the updated OS data. Patients with treatment‐naïve stage IIIB/IV or recurrent nsNSCLC without driver mutations in | PMC10501244 |
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Results | Overall, 550 patients were randomized. At the time of the analysis (minimum follow‐up: 19.4 months), the median OS was longer in the nivolumab arm than in the placebo arm (30.8 vs. 24.7 months; hazard ratio 0.74, 95% confidence interval 0.58–0.94). The 12‐month OS rates were 81.3% vs. 76.3% in the nivolumab vs. placebo arms, respectively. The respective 18‐month OS rates were 69.0% vs. 61.9%. | PMC10501244 |
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Conclusion | NSCLC, treatment‐naive | LUNG CANCER, ONCOLOGY, NSCLC | Nivolumab plus platinum chemotherapy and bevacizumab demonstrated longer OS vs. the placebo combination. We believe this regimen is viable as a standard, first‐line treatment for patients with advanced nsNSCLC without driver mutations in The ONO‐4538‐52/TASUKI‐52 study investigated the efficacy and safety of nivolumab versus placebo, both combined with platinum chemotherapy and bevacizumab, as first‐line treatment for advanced non‐squamous non‐small cell lung cancer (NSCLC). After a minimum follow‐up of 19.4 months, overall survival significantly favored the nivolumab arm, and this survival benefit was observed regardless of programmed death‐ligand 1 expression level. These results indicate that nivolumab plus platinum chemotherapy and bevacizumab is an effective option for treatment‐naive patients with advanced non‐squamous NSCLC without driver mutations.
Data reported in this manuscript were submitted as an abstract to the 2022 Annual Meeting of the Japanese Society of Medical Oncology. Interim results were published as Sugawara et al.Study registration numbers: | PMC10501244 |
INTRODUCTION | NSCLC, tumor | LUNG CANCER, TUMOR, NSCLC | Clinical trials have demonstrated that immune checkpoint inhibitors, when administered as monotherapy or administered together with appropriate chemotherapy regimens, are promising as first‐line treatments for non‐small cell lung cancer (NSCLC) in the absence of driver mutationsIn a Japanese phase II study, nivolumab numerically prolonged OS in the order of tumor programmed death‐ligand 1 (PD‐L1) expression levels of <1%, 1%–49%, and ≥ 50% in previously treated patients with non‐squamous NSCLC. | PMC10501244 |
MATERIAL AND METHODS | As previously described,The eligibility criteria are described in detail in our previous report.Overall, 550 patients (275 per arm)Only data for OS were analyzed through to the cutoff date of February 10, 2021 (minimum follow‐up, 19.4 months) using the intention‐to‐treat analysis set. We used the Kaplan–Meier analysis method to estimate the OS and the Brookmeyer–Crowley method with double‐log transformation was used to calculate 95% confidence intervals (CIs). For subgroup analyses, the Cox proportional hazards model was utilized to calculate unstratified HRs (together with the 95% CIs). | PMC10501244 |
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RESULTS | PD‐L1, Cancer | ONCOLOGY, MALIGNANT TUMORS, CANCER | The baseline characteristics of patients in the nivolumab and placebo arms are presented in Table Baseline patient characteristics.Abbreviations: ECOG PS, Eastern Cooperative Oncology Group performance status; PD‐L1, programmed death‐ligand 1; TNM, the TNM classification of malignant tumors; UICC, Union for International Cancer Control.Interactive Web Response System source.Former smokers included anyone who had smoked even a small quantity of any tobacco and had stopped smoking at the time of screening. Current smokers are anyone who had a smoking habit of any tobacco regardless of smoking duration/quantity at the screening.There were five patients with indeterminate PD‐L1 expression levels in both arms.Overall survival with a minimum follow‐up period of 19.4 months (Kaplan–Meier plot). CI, confidence interval; HR, hazard ratio; OS, overall survival; mo, months.Subgroup analysis of overall survival. CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; HR, hazard ratio; mo, months; NR, not reached; OS, overall survival; PD‐L1, programmed death‐ligand 1.Overall survival in patients stratified by programmed death‐ligand 1 expression level (Kaplan–Meier plots). There were five patients with indeterminate PD‐L1 expression levels in both arms. CI, confidence interval; HR, hazard ratio; mo, months; OS, overall survival; PD‐L1, programmed death‐ligand 1; NR, not reached. | PMC10501244 |
DISCUSSION | tumor, PD‐L1 | TUMOR | We performed updated analyses of treatment‐naïve patients with advanced nsNSCLC without driver mutations who were enrolled in a placebo‐controlled randomized trial in three Asian countries. At the data cutoff at which time the minimum follow‐up was 19.4 months, the nivolumab arm showed longer OS vs. placebo (HR 0.74, 95% CI 0.58–0.94). This compares with an HR of 0.85 in the primary analysis, which had a shorter minimum follow‐up (7.4 months). These findings expand on our prior analysis,To our knowledge, this is the first randomized, placebo‐controlled trial to reveal a survival benefit of an anti–PD‐1 antibody (nivolumab) administered together with bevacizumab and chemotherapy as initial, first‐line therapy of advanced nsNSCLC. An improvement in the tumor microenvironment may be conferred through synergistic effects of bevacizumab and nivolumab.When patients were divided into subgroups by tumor PD‐L1 expression level, we observed a significant OS benefit in the PD‐L1 1%–49% group and a fair OS benefit in the <1%/indeterminate and ≥ 50% groups. This is inconsistent with the prior data showing that the PFS benefit was observed regardless of the PD‐L1 expression level, and that the PD‐L1 1%–49% group had the lowest numerical PFS benefit.The effects of first‐line atezolizumab combined with PCB for treating wild‐type metastatic nsNSCLC were recently reported in a Phase III study.The main limitation of this updated survival analysis is that only OS data were obtained; PFS and safety data were not updated. Further follow‐up of OS, PFS, and safety and future analyses are needed to comprehensively discuss the benefits of nivolumab.In conclusion, nivolumab plus PCB provided superior OS vs. placebo plus PCB for the initial (first‐line) treatment of patients with metastatic nsNSCLC. Therefore, we believe that nivolumab plus PCB is a viable new option for the initial treatment of metastatic nsNSCLC without driver mutations in | PMC10501244 |
AUTHOR CONTRIBUTIONS | PMC10501244 |
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FUNDING INFORMATION | This study was funded by Ono Pharmaceutical Co., Ltd., and Bristol‐Myers Squibb. | PMC10501244 |
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CONFLICT OF INTEREST STATEMENT | EPS | Ono Pharmaceutical Co., Ltd. and Bristol‐Myers Squibb funded the study, provided the study drugs, and were involved in the collection, analysis, and interpretation of the data. Employees of the sponsors reviewed and commented on the manuscript. The authors had full access to the data and took final responsibility for the decision to publish the manuscript.The authors report the following disclosures; remuneration of 1 million yen or more: S.T. (Ono Pharmaceutical); lecture fees/honoraria/other fees of 500,000 yen or more: H.‐R.K. (Ono Pharmaceutical, AstraZeneca, Roche, Boehringer Ingelheim), S.S. (Ono Pharmaceutical, Bristol‐Myers Squibb), T.H. (Ono Pharmaceutical, Bristol‐Myers Squibb), K.‐H.L. (Bristol‐Myers Squibb, MSD, AstraZeneca, Pfizer, and Eli Lilly), T.Y. (Ono Pharmaceutical, Chugai, AstraZeneca), H.T. (AstraZeneca, Chugai), C.‐T.Y. (Ono Pharmaceutical, Boehringer Ingelheim, AstraZeneca, Chugai, Pfizer, Takeda, Novartis, Roche, Eli Lilly, Merck, MSD), M.N. (Ono Pharmaceutical, Bristol‐Myers Squibb), Y.O. (AstraZeneca, Chugai), T.T. (Cmic ShiftZero), H.A. (AstraZeneca), N.Y. (MSD, AstraZeneca, Chugai, Eli Lilly, Boehringer‐Ingelheim, Pfizer, Ono Pharmaceutical, Takeda), K.N. (Eli Lilly, Chugai, Ono Pharmaceutical); annual contract research grants of 1 million yen or more: H.‐R.K (Ono Pharmaceutical), S.S. (Ono Pharmaceutical, Bristol‐Myers Squibb), J.‐S.L. (Ono Pharmaceutical), J.‐H.K. (Ono Pharmaceutical), N.I. (Ono Pharmaceutical), T.H. (Ono Pharmaceutical, Bristol‐Myers Squibb), K.‐H.L. (Ono Pharmaceutical), T.Y. (Ono Pharmaceutical, Chugai, AstraZeneca, Amgen, Novartis, Bristol‐Myers Squibb, Takeda), H.T. (Ono Pharmaceutical), C.‐T.Y. (Ono Pharmaceutical), M.N. (Ono Pharmaceutical, Bristol‐Myers Squibb), Y.O. (AstraZeneca, Chugai, Eli Lilly, Ono Pharmaceutical, Bristol‐Myers Squibb, Kirin, Dainippon‐Sumitomo, Pfizer, Taiho, Novartis, Takeda, Kissei, Daiichi‐Sankyo, Janssen, LOXO), N.Y. (Chugai, Toppan printing, Cmic ShiftZero, MSD, Pfizer, PPD, IQVIA, Eli Lilly, A2 healthcare, Boehringer Ingelheim, Terumo, Takeda, AstraZeneca, Amgen, Jansen, Taiho, Ono Pharmaceutical), C.‐J.Y. (Ono Pharmaceutical), H.A. (Chugai, Amgen), K.N. (Ono Pharmaceutical, MSD, Daiichi Sankyo, Taiho, Chugai, SYNEOS HEALTH CLINICAL, Japan Clinical Research Operations, AstraZeneca, IQVIA Services JAPAN, Covance Japan, Takeda, GlaxoSmithKline, Sanofi, EPS Corporation, Novartis, Medical Research Support); scholarship/endowments of 1 million yen or more: N.Y. (Taiho, Chugai, Daiichi‐Sankyo, Ono Pharmaceutical), K.N. (Takeda, Chugai, Ono Pharmaceutical). Y.O. is a member of the editorial board of | PMC10501244 |
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ETHICS STATEMENT | The study was approved by the Institutional Review Board or Independent Ethics Committee at all participating sites. All patients provided informed consent to participate in this study. The study was registered on | PMC10501244 |
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ACKNOWLEDGMENTS | We wish to thank all of the patients together with their families for participating in this study, as well as the investigators and staff at each study site for their contributions. We also thank Yuki Fukuyama of Ono Pharmaceutical Co., Ltd., Osaka, Japan, for providing essential statistical support. The authors thank Nicholas D. Smith (EMC K.K.) for providing medical writing support, which was funded by Ono Pharmaceutical Co., Ltd. | PMC10501244 |
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DATA AVAILABILITY STATEMENT | Qualified researchers may request Ono Pharmaceutical Co., Ltd. to disclose individual patient‐level data from clinical studies through the following website: | PMC10501244 |
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REFERENCES | PMC10501244 |
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Background | sarcopenic obesity | The effects of dietary intervention in managing sarcopenic obesity are controversial, and behavior change techniques are lacking in previous studies which are important for the success of dietary intervention. This study aimed to evaluate the feasibility and preliminary effects of a dietary behaviour change (DBC) intervention on managing sarcopenic obesity among community-dwelling older people in the community. | PMC10521482 |
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Methods | sarcopenic obesity | A two-armed, RCT was conducted. Sixty community-dwelling older adults (≥ 60 years old) with sarcopenic obesity were randomised into either the experimental group (n = 30), receiving a 15-week dietary intervention combined with behaviour change techniques guided by the Health Action Process Approach model, or the control group (n = 30), receiving regular health talks. Individual semi-structured interviews were conducted with 21 experimental group participants to determine the barriers and facilitators of dietary behaviour changes after the intervention. | PMC10521482 |
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Results | RECRUITMENT | The feasibility of the DBC intervention was confirmed by an acceptable recruitment rate (57.14%) and a good retention rate (83.33%). Compared with the control group, the experimental group significantly reduced their body weight ( | PMC10521482 |
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Conclusion | The DBC intervention could reduce body weight, and has positive trends in managing handgrip strength, gait speed, and waist circumference. Interestingly, the subtle difference between the two groups in the change of muscle mass index warrants futures investigation. This study demonstrated the potential for employing dietary behaviour change interventions in community healthcare. | PMC10521482 |
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Trial registration | Registered retrospectively on ClinicalTrailas.gov (31/12/2020, NCT04690985). | PMC10521482 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12877-023-04327-w. | PMC10521482 |
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Keywords | PMC10521482 |
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Background | sarcopenic obesity, sarcopenic | SECONDARY, ADIPOSITY | Low muscle mass/function and excess adiposity, known as sarcopenic obesity, often coexist in older adults [A systematic review [Among the different nutritional interventions, dietary modification is a good way of managing sarcopenic obesity and may produce longer-term benefits than oral supplements alone [Two RCTs showed that a dose of 1.2 g/kg of body weight/day of protein intake could achieve significant increases in muscle mass for sarcopenic older adults [In addition, poor adherence and high dropout rates were often reported in previous dietary interventional trials of older adults, leading to inconsistent results. Successful dietary modifications require participants to adhere to a diet regimen [The primary aims of this pilot trial is to evaluate the feasibility and acceptability of the dietary behaviour change intervention (12% caloric reduction/day + 1.2–1.5 g/kg body weight/day of protein intake) for 15 weeks among community-dwelling older adults with sarcopenic obesity. The secondary aim is to evaluate the preliminary effects of the intervention on body composition, muscle strength, and physical performance. | PMC10521482 |
Methods | This study was reported according to the Consolidated Standards of Reporting Trials (CONSORT) for randomised pilot and feasibility trials [ | PMC10521482 |
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Trial design | This study was conducted as a prospective, two-armed, assessor-blinded, parallel-group, pilot randomised controlled trial (RCT) with an allocation ratio of 1:1. A qualitative interview of the experimental group was conducted after the pilot RCT. This trial was conducted between Jun 2020 and Feb 2021, and it has been retrospectively registered with ClinicalTrial.gov (31/12/2020, NCT04690985). | PMC10521482 |
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Participants | illness, cognitive impairment, overweight or obese [
Inclusion and exclusion, dementia, sarcopenic obesity, Sarcopenia, weight loss, hearing and vision | AUTOIMMUNE DISEASE, SARCOPENIA, HEART DISEASE, METABOLIC DISORDERS | Participants were recruited from June 2020 to November 2020 by convenience sampling. The study was promoted by displaying the posters in three largest community health centres which provided a free annual physical health examination to all citizens from the age of 60 in Nanjing, China, and community staffs also helped introduce the research project to older people who came to receive the free physical health check. Initially, participants were identified to be overweight or obese [
Inclusion and exclusion criteria of the participants(a) community-dwelling older people aged 60 years old or above;(b) who met the diagnostic criteria of sarcopenic obesity according to the Asian Sarcopenia Working Group [i) ii) (c) who were able to communicate, read, and write without significant hearing and vision problems.(a) those with any form of illness or condition that may influence food intake and digestion (such as severe heart disease, metabolic disorders, autoimmune disease, cancer);(b) having cognitive impairment (e.g., dementia), which may impede delivery of the intervention;(c) already adhering to special dietary restrictions, including a diabetes-specific diet, a vegetarian diet, or a ketogenic diet;(d) taking medications that may influence eating behaviour, digestion, or metabolism (such as weight loss medication);(e) being addicted to alcohol, which affects efforts to change dietary behaviour;(f) having any metal device implanted in their body, such as a pacemaker because low-level currents will flow through the body when doing the bioelectric impedance analysis, which may cause the device to malfunction. | PMC10521482 |
Sample size | The primary objective of a pilot study is to explore the feasibility of the study. Therefore, a formal calculation of sample size is not required [ | PMC10521482 |
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Randomisation and blinding | The block randomisation method (block size = 4) was utilized, to ensure that an equally balanced number of participants were allocated to each study group (i.e., the experimental or control groups). The randomisation table was obtained from the Research Randomiser software ( | PMC10521482 |
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Statistical methods | RA | RECRUITMENT | Descriptive statistics (absolute number and percentage of participants) were used to present the length of recruitment, recruitment rate, retention rate, adherence rate, and completion rate of all the measurements. The recruitment rate of 50% and the adherence rate of 60% indicated an acceptable level, and the proportion of missing data for each variable was suggested to be less than 5% [For the acceptability outcomes, the semi-structured interviews were digitally audio-recorded and transcribed verbatim. NVivo 12 software was used to manage the data and help identify common codes from the transcripts. Content analysis was employed inductively to synthesise the categories and themes. Two researchers (the first author and RA) worked independently on the coding and on identifying codes by following the guideline of content analysis [For the analysis of the preliminary effects data, the intention-to-treat (ITT) principle was followed in the data analyses. Descriptive statistics were used to present the demographic data and the feasibility outcomes. Normality assumptions were checked for variables. The homogeneity of the two groups was examined by comparing the demographic and baseline outcomes using an independent t-test or the Mann-Whiteney U test for continuous data at baseline, and the Chi-square test or Fisher’s exact test for dichotomous data. The missing variables were caused by dropouts, which were checked by using missing completely at random (MCAR) method. The generalized estimating equation (GEE) was employed to estimate the time and group effects on the clinical outcomes measured pre- and post-intervention. Two heterogeneous variables, i.e., level of education and body height, were adjusted during the statistical analysis. Considering the covariate effects, all of the GEE analyses were adjusted for three covariates (the variables related to height, level of education, and physical activity level) by considering the significant heterogeneity between the groups. A p-value of < 0.05 was considered statistically significant. | PMC10521482 |
Results | PMC10521482 |
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Feasibility of the intervention | RECRUITMENT | The recruitment process lasted for around six months. The recruitment rate was 57.1% (60/105), and the overall retention rate was 83.3% (50/60) (see Fig. | PMC10521482 |
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Acceptability of the intervention | Twenty-one participants (mean age = 68.19 ± 6.30 years old) from the experimental group attended the semi-structured interview. The adherence of the interviewees to keeping a food diary was diverse, from moderate to good (8/21) and bad (13/21). Four themes with corresponding sub-themes were synthesised from the data: (1) overall perceptions of the DBC intervention; (2) barriers to participating in the DBC intervention; (3) facilitators in implementing the DBC intervention; (4) suggestions for a future programme (see Table
Results of the individual semi-structured interview | PMC10521482 |
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Discussion | sarcopenic obesity | This study demonstrated that the DBC intervention is feasible and acceptable among the target population, as reflected by the relatively high attendance and retention rates, and by the positive feedback from the interviews. This study showed that the DBC could effectively reduce body weight and improve dietary quality among older adults with sarcopenic obesity. However, the effects on building muscles were nonsignificant. | PMC10521482 |
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Feasibility and acceptability of the intervention | We screened around 2,000 people and only 105 people were eligible. The relatively low eligibility rate (5.25%) indicates that extensive screening may be needed in a future study. It is difficult to compare the eligibility rate in this study with those of previous interventional studies because the eligibility rate varied greatly among the different studies. For example, the eligibility rate in some studies could reach 62.36% [The findings of the semi-structured interview revealed both positive and negative aspects of the intervention process. On the one hand, the participants recognised the positive role of the BCTs in encouraging them to modify their dietary habits from unhealthy to healthy. The continuous support from the interventionist during the intervention process was reported as being a crucial factor in bringing about changes in behaviour. Previous studies on lifestyle modifications tended to focus on the provision of knowledge, materials, and professional education, which may be insufficient for making behavioural changes [Contextual cultural factors may pose some barriers to changing dietary behaviour, as reflected by the relatively low rate of adherence to keeping a food diary. According to our qualitative interviews, the barriers included internal factors (e.g., previous eating habits) and external factors (e.g., specific aspects of Chinese dining culture). For example, Chinese families are used to eating together and sharing dishes, which may cause difficulties for participants in controlling the amount of food that they eat compared to individual servings. In addition, some participants were busy taking care of their grandchildren, so they hardly had adequate time to keep a detailed food diary. These external barriers need to be addressed in future research by including family members in the study, to increase the awareness of family members and relieve some of the burden on the participants. | PMC10521482 |
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Preliminary effects of the intervention | The findings on preliminary effects demonstrated that body weight could decreased significantly, with a simultaneous decrease in skeletal muscle. This preliminary finding is similar to that in previous interventional studies [On the other hand, we could observe a non-significant increase in handgrip strength and gait speed and the decrease in waist circumference in the intervention group from baseline to post-intervention. These findings are similar to those of previous nutritional studies [ | PMC10521482 |
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Limitations and strengths | There were some limitations to this study. First, it was challenging to perform double-blinding (blinding of the interventionist and participants) due to the nature of the study. Although we maintained continuous social contact with the control group to avoid the confounding effects of psychosocial contact, it was not possible to compensate entirely for the Hawthorne effect. Second, the method of assessing food intake in this study might have led to bias in estimating the amount of food that was consumed. Because the participants self-reported the amount of their food intake, there might have been variations between the actual amount and the estimated amount, even though the participants had been trained in measurement methods. However, the food diary is the most widely used method in current dietary intervention studies especially in a community-dwelling setting. We also considered using digital methods (e.g., technological equipment or application programs) to help in recording food intake. However, the accuracy of digital methods is yet to be established, and the problems of self-reporting remain unsolved [This study has implications for both clinical practice and research. First, this study provides a good reference for community health providers to use to play a supervisory role in implementing dietary interventions using behaviour change techniques (e.g., workshops or telephone follow-ups), and then to improve the quality of the diets of older adults. Notably, the intervention in this study used an individualised rather than a uniform approach, which is crucial for dietary interventions considering the heterogeneity among participants in terms of lifestyle, mealtimes, confidence, and family context. Second, this study inspired the design for future research, i.e., a longer intervention duration and better-tailored methods for promoting compliance in the keeping of a food diary. In this pilot study, handgrip strength, waist-hip ratio, and gait speed all showed a non-significant positive change. Supposing these parameters could be significantly changed in a longer intervention duration and a bigger sample size. | PMC10521482 |
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Conclusion | sarcopenic obesity | This pilot study supports the view that a dietary intervention combined with behaviour change techniques is a feasible and acceptable programme for older adults with sarcopenic obesity. The DBC intervention could reduce body weight, and has positive trends in managing handgrip strength, gait speed, and waist circumference. Interestingly, the subtle difference between the two groups in the change of muscle mass index warrants futures investigation. The effects of the DBC intervention on managing sarcopenic obesity could be further explored in a future study with a bigger sample size and longer intervention duration. | PMC10521482 |
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Electronic supplementary material | Below is the link to the electronic supplementary material.
Supplementary Material 1 | PMC10521482 |
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Acknowledgements | We sincerely thank the community health centres in Nanjing, China for the support in providing data collection settings. We thank faculties of Nanjing Medical University for helping connect the research settings. We also thank the experts involved in Delphi methods for their professional comments, research assistants for their wonderful work, and all the participants for participating in this study. | PMC10521482 |
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Authors’ contributions | YHY, JYWL and MV were all involved in the design of the study and initiated the study. YHY was accountable throughout for the data collection and data analysis, and drafted the manuscript. JYWL was accountable for the quality control of the study. JYWL and MV both commented and rewrote the manuscript. All authors read and approve the final version of the manuscript. | PMC10521482 |
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Funding | This study is funded by The Hong Kong Polytechnic University for supporting postgraduate students, the grant number is not available. | PMC10521482 |
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Data Availability | The data and materials are not publicly availabe as the participants did not consenting to share their data. Further detials about the data and ethical conditions are available from the corresponding author on reasonable request. | PMC10521482 |
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Declarations | PMC10521482 |
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Ethics approval and consent to participate | All methods were performed in accordance with the Declaration of Helsinki. This study obtained ethical approval from the research committee of The Hong Kong Polytechnic University (HSEARS20191007001) and the community centres. The written informed consent of the participants was obtained prior to the collecting of data. | PMC10521482 |
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Consent for publication | Not applicable. | PMC10521482 |
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Competing interests | The authors declare no competing interests. | PMC10521482 |
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References | PMC10521482 |
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Purpose | The opportunities for surgical training and practice in the operating room are in decline due to limited resources, increased efficiency demands, growing complexity of the cases, and concerns for patient safety. Virtual reality (VR) offers a novel opportunity to enhance surgical training and provide complementary three-dimensional experience that has been usually available in the operating room. Since VR allows viewing and manipulation of realistic 3D models, the VR environment could enhance anatomical and topographical knowledge, in particular. In this study, we explored whether incorporating VR anatomy training improves novices’ performance during mastoidectomy over traditional methods. | PMC10796652 |
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Methods | Thirty medical students were randomized into two groups and taught mastoidectomy in a structured manner. One group utilized a VR temporal bone model during the training while the other group used more traditional materials such as anatomy books. After the training, all participants completed a mastoidectomy on a 3D-printed temporal bone model under expert supervision. Performance during the mastoidectomy was evaluated with multiple metrics and feedback regarding the two training methods was gathered from the participants. | PMC10796652 |
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Results | injuries | The VR training method was rated better by the participants, and they also needed less guidance during the mastoidectomy. There were no significant differences in operational time, the occurrence of injuries, self-assessment scores, and the surgical outcome between the two groups. | PMC10796652 |
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Conclusion | Our results support the utilization of VR training in complete novices as it has higher trainee satisfaction and leads to at least as good results as the more traditional methods. | PMC10796652 |
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Supplementary Information | The online version contains supplementary material available at 10.1007/s00405-023-08143-1. | PMC10796652 |
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Keywords | Open access funding provided by University of Eastern Finland (UEF) including Kuopio University Hospital. | PMC10796652 |
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Introduction | Increased concern for patient safety and operating room efficiency, shorter workweeks and the ever-increasing complexity of the surgical cases have decreased the number of opportunities the residents have for hands-on training [Numerous studies have suggested that utilizing virtual reality (VR) technology in surgical training might be beneficial [In general, surgical training the effectiveness of VR simulators has been proved mainly in novices, with a positive effect on both laparoscopic and open procedures [While the simulators have been in the spotlight, there has been less interest in the other possibilities of VR technology. A recent meta-analysis of VR’s effectiveness on anatomical training, without the inclusion of a simulator, reported that VR increased the test scores when compared to traditional methods [Mastoidectomy (Image Overview of mastoidectomy on a cadaver temporal bone. Presently, cadaveric temporal bone training is the gold standard for learning mastoidectomy [In the future, another option for hands-on training besides VR simulators could be 3D-printed anatomical models. 3D-printed temporal bones have some possible advantages to VR simulation as the haptic feedback is presumably better and genuine equipment can be used. On the other hand, VR simulation can include the soft tissues as well and repetitions do not incur extra costs. 3D-printed temporal bones have already been investigated in a few studies [In the present study, we evaluate the validity of anatomical VR training by comparing it to the traditional way of training including anatomy books, dissection guides and expert instruction in complete novices. After the training, the participants perform a mastoidectomy and their performance is evaluated. Feedback related to the training methods is also gathered. Our main hypothesis was that the VRT group would perform better based on the presumed advantage of obtaining a better 3D understanding of the anatomy. Using three objective measures (operation time, need of assistance, and the Welling scale score [ | PMC10796652 |
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Materials and methods | PMC10796652 |
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Study design | This study was designed as a prospective randomised study. We recruited medical students with minimal experience in surgery and randomly split them into two groups: the virtual reality group (VRT) and the traditional training, control group (TT). Both groups received identical training utilizing two different methods and then performed a mastoidectomy on 3D-printed temporal bone models. Participants’ performance was evaluated after the training drilling was completed. Participants were volunteers and signed an informed consent form. There were no risks or benefits included for the participants. An organizational permit was applied for and granted by Kuopio University Hospital (permit number: 5551879). | PMC10796652 |
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Mastoidectomy drilling procedure | SCHMIDT | All participants performed a mastoidectomy on 3D-printed temporal bone models (Temporal Bone Patient “Schmidt”, Phacon, USA, Atlanta) using a surgical microscope (Zeiss Omni Pico), a surgical high-speed drill with irrigation and a suction tool (Image Task 1: Identify the correct starting position from the landmarks on the surface of the temporal bone and drill away enough mastoid air cells to reveal dura lamel.Task 2: Identify the sigmoid sinus and the sinodural angle. Clear the air cells over the dura lamel, the sigmoid sinus and the sinodural angle.Task 3: Continue removal of the aircells to find the antrum.Task 4: Locate the lateral semicircular canal and the corpus of the incus.Task 5: Thin the posterior canal wall sufficiently.Task 6: Locate the facial nerve and finish the mastoidectomy by removing any leftover air cells.Left image: mastoidectomy drilling setup with a 3D-printed temporal bone model, a surgical microscope attached to an external screen, a surgical drill, and a suction tool. Right image: a microscopic view of a mastoidectomy in a 3D printer temporal bone. The yellow line represents the approximated location of the facial nerve under the bone. | PMC10796652 |
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Factors and performance metrics | PMC10796652 |
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Evaluation of the training method | APPENDIX | After the training session, each participant filled out a structured evaluation form (Appendix 1.) in which they evaluated the training method used. Free-form feedback was also collected about the possible advantages or the drawbacks of each method. The result of the survey was also utilized for monitoring quality control between the training sessions in each participant.The same evaluation was repeated right after the procedure was finished. | PMC10796652 |
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Operational time and the need for assistance | APPENDIX | During the procedure, the authors recorded the timestamps of completed subtasks related to the important landmarks using custom-made software (Python 3.9) (Appendix 4.). The software also logged the total operational time and the timestamps of participants’ requests for assistance. | PMC10796652 |
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Self-assessment | ANDERSEN, APPENDIX | After the procedure, the participants assessed their own performance using a structured form (Appendix 2.) by Andersen et al. [ | PMC10796652 |
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Surgical outcome | injuries | A blinded evaluation of the drilled 3D-printed temporal bones was carried out by two experts using a modified Welling Scale [For getting an overall and the most objective evaluation of the participants’ performance, a non-weighted composite variable was formed based on Possible correlations between the time to completion, the amount of assistance needed, the surgical outcome, the possible injuries and the self-assessments were also explored. | PMC10796652 |
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Statistics | Statistical analysis was conducted in the SPSS Base 27.0 Statistical Software Package (SPSS Inc, Chicago, IL, USA). The performance of the two groups were compared with the independent samples Mann—Whitney | PMC10796652 |
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Discussion | infections, mistakes | INFECTIONS, COMPLICATIONS | In this prospective randomized study, we taught mastoidectomy to 30 volunteer medical students with two training methods (VR and traditional) and assessed their performance using multiple subjective and objective metrics related to mastoidectomy performance. We recruited medical students without any prior experience in mastoidectomy to ensure comparable initial conditions regarding the participants’ surgical skills and knowledge. To our knowledge, this is the first prospective and randomized study to evaluate the feasibility of utilizing a 3D anatomical model in VR for training mastoidectomy without the inclusion of VR simulator training. Our goal was to explore whether VR training steepens the learning curve of mastoidectomy and if it could be utilized as a complementary method in future surgical training.Overall, the participants rated the VR training method better than the traditional method. Consistent with previous research, the differences were most notable when considering 3D perception which was often regarded as the strength of the VR method and weakness of the TT method. Understandably, this is the clear advantage of a fully 3D model over the 2D printed images seen in the anatomy books. The individual categorical scores for both methods decreased after the mastoidectomy. This seems to indicate that in retrospect the participants felt the training did not match the real world as well as they initially thought. Despite that, the mean overall grade given for the VR method did not decrease in the second evaluation which is in clear contrast with the TT method.Disadvantages most often reported by the VRT group were the lack of colours and soft tissues in the model, small problems with the equipment and the view (such as a difficulty to achieve a sharp picture) as well as the difficulty of understanding the real proportions of the structures. In the future it is likely that technical advancements can amend at least some of these concerns.Even though the VRT group required less assistance during the operation, they were not faster nor was their outcome better than the TT group and they made a similar number of mistakes. We expected that a possible increase in understanding of the mastoidectomy prior to drilling would reflect in the number of assistance requests, operational time and the number of mistakes as well as the outcome. Based on our results this was not the case and it is unclear whether the difference in the amount of assistance needed reflects better knowledge obtained. The numerous injuries observed here could point to insufficient ability to identify and understand where the critical structures are or that the technical skills were not adequate for the task. Of course, there is still the possibility that one of the methods gave a superior understanding of the anatomy and the procedure, but the participants did not have the technical skills to match that.To holistically understand each participants’ performance, a non-weighted composite variable was created based on the operational time, the amount of assistance needed and the Welling score. These variables were chosen as a simplified indication of a successful surgery as an experienced surgeon should be able to perform a routine procedure in a timely manner, without any help and with excellent results. Evaluating surgical performance based on operational time and technical adequacy is supported by current data. For example, longer operational times have been shown to increase the risk of surgical infections and other complications leading to a worse outcome for the patient [Our findings show that the VR method did not seem to significantly overcome the traditional training methods. At the same time, there were no notable advantages for the traditional methods either. It is also clear that the participants preferred the VR method over the traditional books and this aspect should be accounted for in the future development of mastoidectomy training. These results are in line with previous research [While VR is getting more adopted in anatomy training, evaluation of its outcomes and effectiveness in previous studies have been limited to written exams instead of a simulated procedure [The clear strength of our study is the randomized and prospective approach together with the inclusion of the many different metrics of performance and methods proposed in the literature and combining them all together in this single study for the first time. While our sample size remains quite small in absolute terms, it is one of the largest when compared to earlier studies conducted on similar subjects. Our study is also the first one to explore the usage of VR for purely anatomical and theoretical training of mastoidectomy without the need for a more costly VR simulator. A recent meta-analysis on VR simulators in temporal bone surgery shows promising results for simulator training [Further research will focus on study replication in a typical training situation with the repeated training sessions and increased sample size of residents. In this study, the surgical training was conducted after only a single instruction session. Repeated instruction and surgical sessions might reveal changes in participant’s learning curve over time.In addition, recruiting residents instead of medical students will open new, relevant insights into the use of VR in their training. For example, residents’s initial anatomical knowledge and relevant surgical skills would likely vary within the group and differ greatly compared to the current sample size of medical students.Due to the low number of ENT residents in Finland, it was unfeasible to recruit a sufficient population of residents in this study. Nevertheless, participants with minimal surgical background allowed us to examine the hypothesized benefits of VR, especially in terms of obtaining improved topographical understanding and increased performance in their first mastoidectomy. Although mastoidectomy is undeniably a complex and demanding procedure for a senior resident and even more so for medical students, the selected procedure and training setup provided the recruited participants with additional advantages.Mastoidectomy drilling with 3D-printed bones represented a genuine surgical procedure that provided an authentic yet safe practice ground that could be easily replicated for all participants. In addition, the surgical training was completed in the training center that strongly resembled operating room setting. Taken together, medical students could experience complex surgical training in close-to-authentic conditions and ahead of their potential residency.With respect to the research questions, the complex procedure allowed us to examine impact of VR in the highly authentic tasks, as opposed to traditional, simplified training. The complex training also contributed to research on skill transfer (i.e., how simulation training transfers to authentic operations), which is understudied in the current research on surgical innovations and training. In future work, we will also systematically evaluate participant’s surgical performance with respect to the selected model (i.e., cadaveric and 3D-printed models) and factor in participants’ personal traits and technical skills to examine the impact of training method.Originally, we had planned to also analyse the operational times of the individual steps of the procedure. Due to the dynamic nature of mastoidectomy, these steps were completed in order that varied across participants. To provide the most authentic experience, we did not enforce a particular order of the individual steps such that other performance variables were not compromised. Due to the variable order and the sample size, the analysis of the individual steps would be misleading.In conclusion, the VR method seems to be at least as good as the traditional method when considering the training of a complex and demanding surgical procedure for novices with the added benefit of increased trainee satisfaction. | PMC10796652 |
Funding | Open access funding provided by University of Eastern Finland (UEF) including Kuopio University Hospital. State Research Funding of the Kuopio University Hospital. The Finnish Medical Foundation. Suomen korvakirurgiyhdistys. | PMC10796652 |
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Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10796652 |
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Declarations | PMC10796652 |
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Conflict of interest | The authors have no conflict of interest to disclose. | PMC10796652 |
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References | PMC10796652 |
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Objectives | SWo and SG are joint senior authors.‘Healthier Wealthier Families’ (HWF) seeks to reduce financial hardship in the early years by embedding a referral pathway between Australia’s universal child and family health (CFH) services and financial counselling. This pilot study investigated the feasibility and short-term impacts of HWF, adapted from a successful Scottish initiative. | PMC10668198 |
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Methods | Setting: CFH services in five sites across two states, coinciding with the COVID-19 pandemic. Participants: Caregivers of children aged 0–5 years experiencing financial hardship (study-designed screen). Design: Mixed methods. With limited progress using a randomised trial (RCT) design in sites 1–3 (March 2020–November 2021), qualitative interviews with service providers identified implementation barriers including stigma, lack of knowledge of financial counselling, low financial literacy, research burden and pandemic disruption. This informed a simplified RCT protocol (site 4) and direct referral model (no randomisation, pre–post evaluation, site 5) (June 2021–May 2022). Intervention: financial counselling; comparator: usual care (sites 1–4). Feasibility measures: proportions of caregivers screened, enrolled, followed up and who accessed financial counselling. Impact measures: finances (quantitative) and other (qualitative) to 6 months post-enrolment. | PMC10668198 |
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Results | including reduced stress | 355/434 caregivers completed the screen (60%–100% across sites). In RCT sites (1–4), 79/365 (19%–41%) reported hardship but less than one-quarter enrolled. In site 5, n=66/69 (96%) caregivers reported hardship and 44/66 (67%) engaged with financial counselling; common issues were utility debts (73%), and obtaining entitlements (43%) or material aid/emergency relief (27%). Per family, financial counselling increased income from government entitlements by an average $A6504 annually plus $A784 from concessions, grants, brokerage and debt waivers. Caregivers described benefits (qualitative) including reduced stress, practical help, increased knowledge and empowerment. | PMC10668198 |
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Conclusions | Financial hardship screening via CFH was acceptable to caregivers, direct referral was feasible, but individual randomisation was infeasible. Larger-scale implementation will require careful, staged adaptations where CFH populations and the intervention are well matched and low burden evaluation. | PMC10668198 |
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Trial registration number | ACTRN12620000154909. | PMC10668198 |
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STRENGTHS AND LIMITATIONS OF THIS STUDY | The lessons from this pilot can inform planning for implementation and evaluation at scale, to maximise the potential benefits generated by the model.Limitations included small sample sizes, short-term follow-up, lack of control group and lack of quantitative data on non-financial impacts.The study prioritised families who are often excluded from research and used a pragmatic and high-quality mixed-methods approach.The iterative approach to piloting in five sites across two Australian states, and during the COVID-19 pandemic, enabled identification of design components that contributed to feasibility.It is anticipated that the Healthier Wealthier Families model would be more feasible in the postpandemic context, as financial supports ended, and cost-of-living pressures increased. | PMC10668198 |
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Introduction | adversity | Strengthening financial security can buffer families from early adversity and enhance the environments that help children thrive.While the mechanisms are complex, it is understood that increased household income benefits children directly through better food, stable housing and healthcare (the investment model), as well as indirectly through improving parental mental health and thus parental capacity (the family stress model).Across many high-income countries, financial counselling services are freely available to help people overcome barriers to accessing entitlements and other financial supports, typically funded by governments. In Australia, however, services remain embedded in not-for-profit organisations and unconnected to the broader system.The current study, ‘Healthier Wealthier Families’ (HWF), sought to adapt the Scottish model to the Australian service context and evaluate the model via a pilot randomised controlled trial (RCT). | PMC10668198 |
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Methods and analysis | PMC10668198 |
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Setting | adversity | DISEASE | Australia’s universal Child and Family Health (CFH) services offer free, community-based healthcare to families with children from birth to school entry. Available in all Australian jurisdictions, CFH services are delivered by nurses, often in partnership with allied health providers and working with interpreters as needed. The services are mostly clinic-based and offer broad ranging support for children’s health, development and parental well-being. In some jurisdictions, CFH services offer higher intensity support (more, longer and home-based appointments) for families experiencing increased health risks and social adversity. These service streams are differentiated with the labels ‘universal’ and ‘higher intensity’ throughout.Australian CFH services already identify and respond to adverse experiences such as poor parental mental health and family violence. While the service frameworks recognise financial hardship as a social adversity affecting child and family outcomes, there is a gap in practice in systematically identifying and responding to this need. The HWF pilot was tested with CFH services in lower socioeconomic communities in Australia’s two most populous states, Victoria and New South Wales. The study was planned before the COVID-19 pandemic, but implementation and evaluation occurred during the pandemic and were deeply impacted by Australia’s public health restrictions and economic responses. In brief, stay-at-home orders (lockdown) were Australia’s main measure of disease control until November 2021, when vaccination levels reached 70%–80%. This required CFH and financial counselling services to shift to telehealth within weeks, and saw many CFH services seconded to other pandemic-related duties. To offset the economic fallout of lockdown, the government implemented a range of financial supplements and supports in April 2020. By September 2020, this financial response had reduced poverty and housing stress beyond prepandemic levels; however, financial hardship had rebounded a year later after financial supports were withdrawn.
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Design | RECRUITMENT | When the HWF pilot study was registered with the Australian and New Zealand Controlled Trials Registry (ACTRN12620000154909, 13 February 2020), it was designed as a feasibility RCT in one Victorian site. However, implementation and evaluation during the COVID-19 pandemic required protocol iterations developed through continuous quality improvement, which incorporated quantitative and qualitative elements. When recruitment ended on 30 June 2022, we had attempted iterations of HWF in five sites across two states. Overall, the model was infeasible in sites 1–4 and feasible in site 5. Healthier Wealthier Families data collection phases and research designs. RCT, randomised controlled trial.Methods for the Healthier Wealthier Families implementation and quantitative evaluationIn the last year, because of money pressure, caregiver missed or put off: (a) mortgage or rent repayments, (b) electricity, gas, water bills, (c) buying prescription medicines, (d) paying home or car insurance.No one in household has a paid job.Family does not have at least $A500 in savings for an emergency.Potential participants who agreed to complete screening survey (CFH report based on service records).Eligible caregivers who consented to participate (CFH and study records).Participants who accessed, attended and completed the intervention (financial counsellor report, caregiver report).Caregivers who completed the follow-up questionnaire (study completion records).CFH, child and family health; CONSORT, Consolidated Standards of Reporting Trials; RCT, randomised controlled trial; STROBE, Strengthening The Reporting of Observational Studies in Epidemiology.To understand barriers to feasibility encountered in 2020, a qualitative implementation evaluation commenced in February 2021 (Methods for the Healthier Wealthier Families implementation and qualitative evaluationIn sites 2 and 3, R3 and R4 conducted interviews with the service providers. R3 and R4 had established relationships with the team in site 3 from regular project meetings but no previous relationship with the provider in site 2.In sites 4 and 5, R2 conducted interviews with the service providers; there were no existing relationships. As R1 had previous interactions they did not conduct these interviews.In site 5, R1 and R2 conducted the caregiver interviews; there were no existing relationships.The involvement of R1 and R3 in the conceptualisation and implementation of the project meant there was the potential for bias related to emotional investment.Reflexive journals were kept by R1 and R3 and used to document reflections after their interviews/focus group.In sites 2 and 3: R3 conducted a focus group with 5 CFH providers and one interview with a CFH provider.In site 3: R4 conducted interviews with CFH providers and one financial counsellor.In sites 4 and 5: R2 conducted interviews with 6 service providers one caregiver.In site 5: R1 conducted interviews with seven caregivers.In site 3, 5 service providers were invited to participate and none (0) declined.In site 4, 10 service providers were invited to participate, 4 did not respond, 1 declined, 1 agreed but was sick on the day of the interview and was not rescheduled.In site 5, 10 caregivers were interested in participating; however, 2 were not interviewed. One was unavailable at their scheduled interview time. One was not engaged due to difficulties in finding an interpreter in their first language.Data in sites 2 and 3 were collected by a focus group held face-to-face and individual interviews conducted by phone. These were recorded verbatim, transcribed by an external agency, cleaned and saved as Word document.Data in sites 4 and 5 were collected via phone or videoconferencing. These were electronically transcribed, cleaned and saved as Word documents.CFH, child and family health; NSW, New South Wales.Experiences and perceptions of the screening and referral processes:1.1. CFH providers had differing opinions about the usefulness of financial screening and relevance to their own practice, which were related to delivery of universal or higher intensity services.1.2. There were issues with engagement due to the research processes.1.3. The COVID-19 pandemic affected service provision and levels of financial hardship.Barriers to identifying financial hardship and accepting help included:2.1. Stigma surrounding financial hardship and accepting a referral to a financial counsellor.2.2. Financial counselling was not well understood by CFH providers or families.2.3. Clients in crisis may have other priorities.2.4. Financial literacy and cultural and family considerations.Factors that enable engagement with families with the HWF model (classified as suggestions rather than subthemes):Support service providers to understand the role of financial counselling.Provide resources to families about financial hardship and financial counselling.Ensure accessible and inclusive communication.Financial counselling services provide client-centred care, not service led.The above themes and findings informed iterations to the HWF protocol that were trialled with two new sites (sites 4 and 5, commencing mid-late 2021, see | PMC10668198 |
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Design iterations | For site 4, the RCT protocol was simplified. Research processes such as informed consent and questionnaires were shortened, and follow-up was reduced from two caregiver surveys at 3 and 6 months to one at 6 months (see More substantive design changes were implemented for site 5. Instead of an RCT, the model employed direct referral with a pre–post evaluation (see In January–June 2022, we conducted a second phase of the implementation evaluation to understand barriers to and enablers of feasibility in sites 4–5 ( | PMC10668198 |
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Patient and public involvement | Patients and service providers were involved in the design and conduct of this research. During the feasibility stage, the choice and acceptability of financial hardship items was informed by discussions with CFH providers and financial counsellors, and between CFH providers and their clients. During the implementation evaluation, the trial processes were reviewed with providers in sites 2–5 and caregivers in site 5. Once the trial is published, findings (in academic and lay outputs) will be available on the study website ( | PMC10668198 |
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Results | PMC10668198 |
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Feasibility (aim 1) | PMC10668198 |
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Disclosure of financial hardship (eligibility) | In the universal CFH service sites, | PMC10668198 |
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Consent/enrolment and follow-up in the study | Across the four RCT sites (1–4), 79 caregivers disclosed financial hardship and were thus eligible ( | PMC10668198 |
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Caregivers who accessed, attended and completed the intervention | In site 3, the two caregivers who were allocated to the control group subsequently identified as high priority and were referred to financial counselling. All six caregivers enrolled in site 3 engaged with the financial counsellor, but no follow-up data were provided. Across the other RCT sites, no other intervention or priority 1 caregivers engaged with the financial counsellor. In site 5, where there were 44 attending caregivers, all appointments were conducted by phone due to the COVID-19 pandemic restrictions. Two-thirds of caregivers used one appointment; 14% used two appointments; 16% used three appointments and 2% used four appointments. Four caregivers missed one appointment and two caregivers missed two, and all were rescheduled. The financial counsellor spent an average of 1.9 hours (SD 1.1) in meetings with attending caregivers (range 0.5–4.75 hours), and an average of 2.2 hours (SD 2.2) outside of meetings on each caregiver’s case (range 0.5–11 hours). By 6 months postreferral, cases were fully closed for 32/44 (73%) caregivers and partially closed (mostly due to disengagement) for 12/44 (27%).In site 5, the most common issues facing caregivers were utility debts (32/44, 73%), awaiting government entitlements (‘Centrelink’, 19/44, 43%) and needing material aid or emergency relief (12/44, 27%). Eighteen per cent of caregivers had borrowed from friends and families; other debts and loans were less frequent. While no caregivers faced bankruptcy, half the caregivers disclosed priority 1 indicators, such as imminent eviction or disconnection of utilities, or being threatened with legal action (n=17/44 (39%) for each category). | PMC10668198 |
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Outcome of feasibility | Overall, the feasibility measures for sites 1–4 met definite Stop criteria for progressing to a larger scale evaluation (defined in | PMC10668198 |
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Short-term impacts identified by quantitative evaluation (aim 2) | PMC10668198 |
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Financial impacts | Centrepay | The lack of follow-up data from caregivers and financial counsellors in the RCT sites 1–4 precludes the analysis described in the published Protocol.Activities and benefits of financial counselling in site 5Centrelink is a government service which provides support to Australians who face financial hardship. Centrepay is a free bill paying service that makes regular deductions from Centrelink payments.Fortnight: biweekly (14 days). (n/a): not applicable.*Top 3: housing/rent assistance (n=7); employment assistance (n=6); emergency relief services (n=3).†Top 3: financial well-being information (n=19, noting n=8 in language other than English); government MoneySmart website (n=18); budgeting with template (n=7).‡Top 3: Centrelink entitlements (n=11); material aid and emergency relief (both n=7). | PMC10668198 |
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Other (non-financial) impacts | As above, the lack of follow-up data across the RCT sites (1–4) precluded the analysis of non-financial impacts described in the published protocolAt CFH screening:Of 28, 11 (39%) caregivers completed the MGMQ, of which 8/11 (73%) disclosed emotional distress (vs not).Only 4/28 (8%) caregivers completed the PWI, mean 42.3 (SD 4.9).At intake with the financial counsellor:Of 49, 43 (88%) caregivers completed the MGMQ, of which 31/43 (72%) reported high emotional distress.Of 49, 38 (78%) caregivers completed the PWI; mean 41.9 (SD 9.7).The follow-up survey was mostly completed by the financial counsellor based on client records and not in-person with the caregiver. As such, completion rates were low:Of 49, 7 (14%) caregivers completed the MGMQ; none reported emotional distress.Of 49, 11 (22%) caregivers completed the PWI; mean 57.2 (SD 11.2). | PMC10668198 |
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Short-term impacts identified by qualitative evaluation (aim 2) | PMC10668198 |
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Caregiver characteristics (site 5) | In site 5, at the final appointment, the financial counsellor invited 39 caregivers to take part in the qualitative interview on behalf of the research team. Ten caregivers agreed and eight took part including one with an interpreter. Of the two who were not interviewed, one was unavailable at their scheduled time, and one was lost due to difficulties in finding an interpreter in their first language. Demographic characteristics were not collected due to ethical approval being only available for deidentified data sharing. | PMC10668198 |
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Caregiver perspectives (site 5) | SAID, COLD | Caregivers who engaged with financial counselling were unanimous in finding the intervention beneficial. Four core themes (benefits) emerged and are presented with illustrative quotes, noting some overlap between themes.Theme 1: Reduced stress and gratitude for emotional support and advocacy received.Caregivers described their relationship with the financial counsellor as being empathetic and respectful. The supportive nature of this relationship helped reduce the acute sense of burden and isolation caregivers were experiencing.My financial counsellor was very supportive. She said you are not alone, there are people out there who are experiencing the same thing. So, she had a good talk to me, and after talking to her, I was able to put myself together. [CAREGIVER 4]Caregivers were grateful for the opportunity to share their problems with a trusted and supportive service provider who listened, and for the strong advocacy they received. They experienced unexpected relief from the sense of pressure and hopelessness they had been feeling before referral to the financial counsellor.… it’s like you’re sharing your feelings with someone. So I was just … I couldn’t speak to anybody about it. So, she’s the one who I am open with … open myself and explain my situation. And I got a very positive response from that time, so it was easy for me after that. [CAREGIVER 13]Theme 2: Immediate solutions: crisis management and practical changes to organisation of finances.Caregivers described several ways in which the financial counsellor assisted them. These included acting as a buffer between the caregiver and creditors; helping caregivers manage debt and bills, access entitlements to maximise their income and prevent a debt spiral; and supporting caregivers to prioritise bill payments according to their goals and needs.She was talking to me in a way that made me feel that she would take care of everything. ‘Don't worry, I will have the payments divided into instalments’ … She helped me organize myself. She showed me how to organize my bills and how to make payments. [CAREGIVER 2]This proactive and practical support provided caregivers immediate reprieve.Because it was a big stress, for me, because always [Utility Company] send me notice—you’re late to pay, you’re late to pay. I can’t pay anyway, I can’t do it, and I was worry. You know, they send me always notice, notice … if they cut electricity, it’s hard because winter, cold, kids. So hard … So, I was so happy when I get [help]. [CAREGIVER 8]Theme 3: Increased knowledge and clarity.Caregivers had increased awareness of the support and options available and that they were entitled to access. Caregivers described the personalised advice about finances provided by the financial counsellor.That’s why it was really useful … she really helped with things that we have no idea existed. Can’t find information on. So it was very informative. [CAREGIVER 3]Caregivers valued the opportunity to ask questions when they did not understand something, and have their questions answered by a trusted service provider who understood their circumstances.What I felt when they helped me with how to make payments and how to organise myself. I told you; my parents are overseas. I thought it was like a family. My father teaching me how to make payments and how to organize myself. That’s my feeling.[CAREGIVER 2]Theme 4: Well-being, self-efficacy and empowermentCaregivers described improvements in their confidence and outlook, including more capacity and efficacy as a parent.But my social worker and financial counsellor has been able to uplift me to make that priority along with my family’s needs and open my mind and eyes to see that everything has to be on time, not to burden myself to make things worse. I know my daughter needs my attention, but I know now I have to do this first in order to be able to look after her the right way. [CAREGIVER 4]Caregivers also described having increased control of their personal situation, more stability and feeling less stranded and stressed.I just can say that it is very good that if woman like me will be aware that you can raise your voice and there is help … we should have more resources to have knowledge that we can go to this way. I think it’s the best way if … we have more awareness for the woman who they are like me … that there is help. No matter what situation you are in, there is help. [CAREGIVER 5] | PMC10668198 |
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Discussion | This Australian pilot study aimed to test the feasibility and short-term impacts of a systematic referral pathway between universal CFH and financial counselling services. While financial hardship screening by CFH providers was broadly acceptable to caregivers of young children, a feasible referral model was established in only one of five sites. Challenges to implementation were exacerbated by the COVID-19 pandemic. Australian policies are increasingly recognising the role of healthcare in addressing early adversitiesStrengths of this study included the iterative, dynamic approach to piloting in five sites across two Australian states. Adaptation of the protocol during the COVID-19 pandemic enabled identification of design components that contributed to feasibility. Recognised by the dynamic sustainability framework,Limitations include the small sample sizes and limited demographic data for describing the qualitative cohorts; the short-term follow-up; lack of control group; and lack of quantitative data on non-financial impacts. In site 5, the pre–post evaluation could have provided a self-control design if pre-enrolment experiences of financial activities (eg, counselling, use of MoneySmart, legal aid) were measured. Further, the high levels of missing data on emotional well-being measures reflected the difficulty in embedding new measures into CFH and financial counselling practice. Indeed, the latter does not typically inquire about caregivers’ mental health needs because it can require a therapeutic response that is outside the scope of practice. Of the available data, there were high levels of emotional distress (low well-being) at screening and intake. While it was reassuring that the available measures (MGMQ and PWI) demonstrated higher emotional well-being at follow-up than intake, the sample sizes were too small to draw conclusions. The substantive challenges encountered in developing a feasible model of HWF (sites 1–4), and collecting quantitative data on non-financial impacts to enable evaluation of a feasible model (site 5) highlight the challenges that are inherent in conducting a definitive multisite effectiveness trial of HWF. Any implementation at scale will require careful and staged adaptations that test how HWF can benefit communities in the ‘post-COVID-19’ landscape. This includes matching of population characteristics to the healthcare intervention, and low burden evaluation through routine data collection. However, we anticipate that the HWF model would become more feasible in the postpandemic context, especially as financial supports ended, and cost-of-living pressures increased.The intention of HWF is to use universal healthcare to screen and respond to financial hardship, to prevent financial crisis and its negative impacts on children and families. The sizeable proportion of caregivers disclosing financial hardship in the universal CFH services was commensurate with the low socioeconomic status of the participating sites. Even so, screening for financial hardship challenged many providers’ perception of their model of care. The levels of financial hardship did not outweigh other negatives such as stigma, lack of knowledge of financial counselling, the burden of the research processes or the pandemic disruption. There are parallels between this study and evaluation of the roll-out of family violence screening by CFH services in Victoria, which found that CFH providers selectively screened women about family violence. | PMC10668198 |
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