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Design, Setting, and Participants | DISORDER, SECONDARY, MAY, EMERGENCY | This is a secondary analysis of the EMBED (Emergency Department-Initiated Buprenorphine For Opioid Use Disorder) trial, a multicentered, cluster randomized trial of a clinical decision support intervention targeting ED initiation of buprenorphine. The trial occurred from November 2019 to May 2021. The study was conducted at ED clusters across health care systems from the northeast, southeast, and western regions of the US and included attending physicians, resident physicians, and advanced practice practitioners. Data analysis was performed from August 2022 to June 2023. | PMC10638655 | |
Exposures | This analysis included both the intervention and nonintervention groups of the EMBED trial. Graph methods were used to construct the network of clinicians who shared in the care of patients for whom buprenorphine was initiated during the trial before initiating the practice themselves, termed | PMC10638655 | ||
Main Outcomes and Measures | Cox proportional hazard modeling with time-dependent covariates was performed to assess the association of the number of these exposures with self-adoption of the practice of ED initiation of buprenorphine while adjusting for clinician role, health care system, and intervention site status. | PMC10638655 | ||
Results | A total of 1026 unique clinicians in 18 ED clusters across 5 health care systems were included. Analysis showed associations of the cumulative number of exposures to others initiating buprenorphine with the self-practice of buprenorphine initiation. This increased in a dose-dependent manner (1 exposure: hazard ratio [HR], 1.31; 95% CI, 1.16-1.48; 5 exposures: HR, 2.85; 95% CI, 1.66-4.89; 10 exposures: HR, 3.55; 95% CI, 1.47-8.58). Intervention site status was associated with practice adoption (HR, 1.50; 95% CI, 1.04-2.18). Health care system and clinician role were also associated with practice adoption. | PMC10638655 | ||
Conclusions and Relevance | SECONDARY | In this secondary analysis of a multicenter, cluster randomized trial of a clinical decision support tool for buprenorphine initiation, the number of exposures to ED initiation of buprenorphine and the trial intervention were associated with uptake of ED initiation of buprenorphine. Although systems-level approaches are necessary to increase the rate of buprenorphine initiation, individual clinicians may change practice of those around them. | PMC10638655 | |
Trial Registration | ClinicalTrials.gov Identifier: | PMC10638655 | ||
Introduction | OUD | DISORDER | Opioid use disorder (OUD) is a major public health problem affecting an estimated 2 million Americans.Social contagion is the spread of behaviors or attitudes within a group of individuals. It has been implicated in the spread of behaviors and characteristics within populations and studied in the adoption of medical practice.Understanding the factors associated with buprenorphine prescribing is critical to designing interventions to increase initiation, a key step in the OUD continuum of care. | PMC10638655 |
Methods | PMC10638655 | |||
Study Design | SECONDARY | This is a post hoc secondary analysis of data collected during the EMBED trial, a cluster randomized trial involving 18 ED clusters across 5 health care systems. Details of the study’s design, including prespecified outcomes, sample size calculations, and randomization procedures, have been published previously. | PMC10638655 | |
Participants | Eligible patient visits were identified with a validated, electronic health record phenotype that included 2 algorithms. The first was based on | PMC10638655 | ||
Variables and Constructs for Analysis | The data were used to construct a dynamic network of buprenorphine initiation and clinician interactions to examine individual, environmental, and social factors contributing to buprenorphine initiation. The nodes were defined as attending physicians, residents, and APPs, and the edges were defined as exposures to buprenorphine initiation. Buprenorphine initiation was defined as ordering buprenorphine for ED administration, prescribing buprenorphine for outpatient use, or authorizing either of these orders. During the study period, ED administration or authorization did not require additional certification or training, but outpatient prescription required an X-waiver for all clinicians, which included 8 hours and 24 hours of additional training for physicians and APPs, respectively. An exposure was defined as a clinician who had not yet initiated buprenorphine during the study but was on a care team for a patient who received buprenorphine from another clinician. The status of each node (as adopter vs nonadopter) was a time-dependent binary variable of whether each clinician had initiated buprenorphine during the study period, and conversion time was set to the day of the encounter where this first initiation occurred. This time to clinician status change from nonadopter to adopter was the primary outcome variable. If 2 or more clinicians on a care team initiated buprenorphine for the first time (eg, 1 doing so by ordering and 1 by authorizing), both were considered to convert at that encounter. Additional covariates included in the model were clinician role (APP, attending physician, or resident physician), a categorical variable denoting which health care system the clinician worked within, the intervention status of the site in the EMBED trial (intervention vs control), and the academic site status. Clinicians occasionally worked at multiple sites with differing status (0.5% for health care system, 5% for academic, and 13% for intervention). Site status variables were assigned by the most common site of exposure. | PMC10638655 | ||
Statistical Analysis | REGRESSION, EVENT | Data analysis was performed from August 2022 to June 2023. The buprenorphine initiation status of each clinician was modeled as a time-to-event survival process with Cox proportional hazards regression, where the event was the first initiation of buprenorphine by a given physician during the study, referred to as the conversion time. Because buprenorphine prescribing status before the study start date was unknown, this represents a time-to-next event analysis since we could not determine whether a buprenorphine initiation event was a clinician’s first ever initiation of buprenorphine. Social contagion was estimated by using the cumulative number of exposures to buprenorphine initiation as a time-dependent variable to measure of the social force associated with individual likelihood to adopt the practice of prescribing buprenorphine. Two cumulative exposure variables were defined: total cumulative exposures and exposure count in the prior 4 months to account for the fact that exposures before the study start period were not observable. For the 4-month exposure variable, all conversions before 4 months were discarded. To examine nonlinearities in the effect of exposures on hazard of conversion, the cumulative exposure variable was modeled with penalized cubic splines with 2 | PMC10638655 | |
Clinicians by Variable and Adoption Status at the End of the Study | Abbreviation: NA, not applicable.See time-to-event analysis in the text for a more detailed estimate of associations between covariate value and adoption status.In sensitivity analyses, conversions and, therefore, exposures before the study start period may have been present but were not measurable, although reported buprenorphine use rates before the study were 0% to 2%. | PMC10638655 | ||
Results | OUD | There were 7831 ED patient visits that met the criteria for OUD, and 728 (9.3%) of these resulted in an initiation of buprenorphine. The set of all encounters involved 1026 unique clinicians (eFigure 1 in | PMC10638655 | |
Clinician Interaction, Exposure, and Adoption Network | Clinician exposure and conversion network for health care system 5 at 4 time points during the study. Each point represents a clinician, and the color denotes whether the clinician had converted to adopter status by the given time.Time-to-event modeling of first buprenorphine initiation using Cox proportional hazards was performed to examine factors associated with clinician adoption of the practice of ED initiation of buprenorphine. We adjusted for clinician type owing to training and regulatory differences by role (eg, the requirement for X-waiver training). Compared with APPs, attending physicians and resident physicians had a lower hazard ratio (HR) for converting to prescriber status (attending physicians, HR, 0.62; 95% CI, 0.43-0.90; resident physicians, HR, 0.52; 95% CI, 0.35-0.78). Intervention site status was also associated with higher rates of adoption (HR, 1.50; 95% CI, 1.04-2.18). The health care system where the clinician worked was significantly associated with the hazard of conversion. Health care system 1 had lower rates of buprenorphine prescribing than all other sites within the study ( | PMC10638655 | ||
Cox Proportional Hazards Model of Prescriber Conversion | Abbreviation: HR, hazard ratio.HRs were calculated with exposure term fit with penalized cubic spline with 2 | PMC10638655 | ||
Association of Conversion to Buprenorphine Prescriber Status With Cumulative Number of Exposures to Buprenorphine Prescribing | The solid line shows the estimated relative conversion rate, and the shaded area denotes the 95% CI.The mean number of other clinicians exposed by an index clinician who adopted the practice was 1.82 (2.5th percentile, 1; 97.5th percentile, 5). eFigure 2 in In sensitivity analyses, time-to-event modeling using the number of exposures in the prior 4 months instead of total prior exposures showed a similar dose-dependent association (eFigure 4 in | PMC10638655 | ||
Discussion | SECONDARY | In this secondary analysis of EMBED trial data on ED initiation of buprenorphine in the setting of user-center CDS, exposure to other physicians who had initiated buprenorphine during the trial was associated with self-adoption of the practice, consistent with a social contagion effect. This was nonlinear, with subsequent exposures having a greater estimated HR than initial ones. These findings were present after controlling for associated factors, including health care system and clinician role. Health care systems showed substantial variation in HR for adoption (The factors identified as contributors to ED initiation of buprenorphine in this study extend prior qualitative research focused on barriers to buprenorphine prescribing. Previous survey and interview studiesThis study also extends prior quantitative work examining the uptake of practice after an intervention by using a time-to-event framework instead of reporting prevalence of the practice, as well as adjusting for health care system characteristics, physician characteristics, social connections, and study duration. | PMC10638655 | |
Limitations | OUD | EVENTS, EVENT | This study has several limitations. First, data on which clinicians had ever prescribed buprenorphine before the study start date are unknown. The adoption end point is, therefore, best interpreted as time-to-next-event analysis from the study start date, and the factors presented here represent HRs for this event as well as demonstrating an additive effect of the trial intervention on contagion of events. This may affect the social contagion analysis by hiding exposures that occurred between adopters before the study start date. The potential effect of these unknown data on the current study is tempered by data showing that the reported rates of buprenorphine use were low across all sites, at 0% to 2% per encounter with OUD, with most sites reporting 0% use. | PMC10638655 |
Conclusions | A challenge facing clinicians in confronting the opioid crisis is how to close treatment gaps including adopting the practice of buprenorphine initiation. Here, we identify that although health care system (and associated system-level factors) is a major factor associated with buprenorphine initiation, these factors may be modifiable through an intervention such as the EMBED CDS tool, as well as social factors relating to observing colleagues adopting a practice. The remaining variability between adoption at a health care system level shows a need for additional efforts to identify barriers to buprenorphine initiation and interventions to target them. These may include robust connection to outpatient clinicians and interventions targeted to change local culture. Furthermore, changes to the X-waiver requirement may impact these barriers. This study identifies not only a role for both top-down systemic efforts to impact buprenorphine initiation rates but how individual clinicians may be able to affect the practice of those around them. | PMC10638655 | ||
Objective: | TYPE 2 DIABETES | To examine the feasibility and implementation of an optimal defaults intervention designed to align grocery purchases with a diet recommended for people with or at-risk for type 2 diabetes. | PMC10564597 | |
Design: | SHOP | This was a 5-week pilot randomised trial with three groups: in-person grocery shopping, shopping online and shopping online with ‘default’ carts. Participants were asked to shop normally in Week One, according to group assignment in Weeks Two–Four (intervention period), and as preferred in Week Five. All groups received diabetes-friendly recipes via email each intervention week. | PMC10564597 | |
Setting: | Participants grocery shopped in person or online. Grocery receipt forms, enrolment information and exit surveys were collected remotely and used to assess feasibility and implementation. | PMC10564597 | ||
Participants: | TYPE 2 DIABETES | Sixty-five adults with or at-risk for type 2 diabetes. | PMC10564597 | |
Results: | Sixty-two participants completed the exit survey and fifty-five submitted receipts all 5 weeks. Forty utilised recipes, 95 % of whom indicated recipes were somewhat or very useful. Orange chicken, quesadillas and pork with potato and apples were the most liked recipes. Most Defaults group participants accepted at least some default cart items. Recipes with the highest default acceptance were whole grain pasta and chicken, quesadillas with black beans and chicken with olives. Participants’ primary concerns about the intervention were costs associated with online shopping, inability to select preferred foods and some recipes including ingredients household members would not eat. | PMC10564597 | ||
Conclusions: | The study had high retention, data were successfully collected remotely and the intervention was acceptable to most participants. Tailoring recipes to household preferences may be beneficial in future studies. | PMC10564597 | ||
Keywords | type 2 diabetes, diabetes | PRE-DIABETES, TYPE 2 DIABETES, DIABETES | In recent estimates, 35 % of adults met criteria for pre-diabetes and 13 % have been diagnosed with type 2 diabetes in the USAIn a 2018 review, Jilcott Pitts Patients with or at-risk for diabetes are one population who may benefit from health promotion efforts in the context of online grocery shopping. Patients with diabetes have reported that ‘unhealthy food is hard to give up,’ ‘nutrition education is difficult to access’ and that ‘it is hard to know what food is healthy’Nudges are one type of behavioural economic intervention that could be introduced in an online grocery shopping environment to promote healthier purchases. Gustafson Another potential behavioural economic strategy is optimal defaults. Default options are pre-determined or automatic choices. Research has shown that optimal default options increase the likelihood of engaging in a target behaviour (e.g. organ donation, ordering healthier side dishes)Our study differs from the Coffino In this article, we discuss measures and outcomes specifically relating to the feasibility and implementation of this study. Implementation outcomes have been conceptualised and defined as acceptability (satisfaction with intervention), appropriateness (perceived usefulness), feasibility (practicability), adoption (uptake), cost, fidelity (adherence), penetration (level of spread) and sustainability (long-term durability) | PMC10564597 |
Methods | RECRUITMENT | The methodology used in this article was informed by a feasibility study conducted by Di Noia Study enrolment data were collected from eligibility screeners which included items that indicated whether participants met the inclusion criteria as well as how the participant heard about the study. To measure enrolment feasibility, we calculated the proportion of eligible participants out of the total screened, the proportion of those eligible that enrolled and the proportion of enrolled participants recruited through each method to help researchers identify the best recruitment tactics for future studies and consider potential changes to some eligibility criteria | PMC10564597 | |
Recruitment, eligibility screening and enrolment | PMC10564597 | |||
Recruitment | MAY, RECRUITMENT, RECRUITMENT | Recruitment took place from Summer 2019 through Fall 2020 except for a brief period from March to May of 2020 when the study was paused due to the initial COVID-19 outbreak in the USA. Although grocery stores were designated an essential service and most remained open during US lockdowns, the research team had concerns over how food shortages, limited store hours and store closures may impact the grocery purchasing experience during this time. Eleven participants (17 %) were recruited and completed all study procedures in early 2020, and the remaining 54 (83 %) were enrolled after recruitment started again in May 2020.Forty-six percentage of participants were recruited through social media advertisements. Social media advertisements were posted on Facebook once per month from June–October of 2020 and cost $360 USD total, with promotional costs ranging from $70 to $120 per post depending on level of engagement. Posts were also shared, but not promoted monetarily, through our laboratory’s Twitter account. Twenty-three percentage of participants were recruited through listservs or websites, including advertisements sent to email lists maintained by our division, the Clinical and Translational Sciences Institute Buffalo Research Registry, the university’s i2b2 listserv | PMC10564597 | |
Eligibility screening criteria | Diabetes | PRE-DIABETES, TYPE 2 DIABETES, DIABETES | Eligibility criteria included (1) 18 years of age or older, (2) a self-reported diagnosis of pre-diabetes or type 2 diabetes or increased risk of developing type 2 diabetes determined by American Diabetes Association type 2 diabetes risk screening results (available at: | PMC10564597 |
Eligibility screening results | TYPE 2 DIABETES, SHOP | Of the 1144 people who completed the eligibility screener, 76 % were ineligible. Reasons for ineligibility were not reporting or meeting type 2 diabetes risk criteria (51 %), not shopping at study grocery stores (23 %), currently receiving SNAP or WIC benefits (10 %), not willing to shop online (7 %), not the primary grocery shopper (4 %), dietary/health restrictions that limited consumption of study foods (3 %) and other reasons (2 %). | PMC10564597 | |
Enrolment | Participants ( | PMC10564597 | ||
Protocol adherence | fifty-four | Complete protocol adherence was defined as submitting a baseline questionnaire, submitting grocery receipt data at least once per week for each of the 5 weeks of the study, and completing the exit survey. Sixty-five participants (100 %) submitted at least some receipt data after randomisation, 55 (85 %) submitted grocery receipt data during all 5 weeks of the study and 62 (95 %) completed the exit survey. All participants submitted Week One (baseline) receipt data, 64 submitted Week Two and Three receipts (99 %), 58 submitted Week Four receipts (89 %) and 62 submitted Week Five receipts (95 %). Of the fifty-five participants that submitted all grocery receipts, fifty-four also completed the exit survey; thus, 83 % of people had complete protocol adherence. See also Fig.
CONSORT flow diagram: implementation of behavioural grocery intervention | PMC10564597 | |
Measures | PMC10564597 | |||
Baseline questionnaire | After consent, baseline questionnaires were emailed to participants. The questionnaire included demographics (age, race/ethnicity, height/weight, sex, education), how often participants usually grocery shopped (bi-weekly, weekly, or more than once per week) and where participants shopped outside of the study stores, including other grocers, farmers’ markets, corner stores, restaurants and coffee shops to better understand usual food purchasing behaviour. | PMC10564597 | ||
Food receipt measures | Throughout the study, participants submitted store receipts and food receipt forms adapted from prior grocery studies | PMC10564597 | ||
Exit survey | SHOP | At the end of the study, participants completed an online exit survey which asked participants to provide feedback on study recipes, online shopping during the study if they indicated they had shopped online during the study period, default shopping carts if they were in the default shopping group, plans to grocery shop online in the future and what they would change about the study. | PMC10564597 | |
Recipes | DISEASE, TYPE 2 DIABETES | Research staff adapted publicly available DASH diet recipes for this study (e.g. recipes from Mayo Clinic, EatingWell, etc.), which were then edited by a registered dietitian (author JM) to ensure alignment with recommendations for people with or at-risk for type 2 diabetes. Recipes were designed to be applicable to all participants regardless of gender, activity level and disease severity. For this reason, we chose not to adhere to rigid guidelines for calories or specific nutrients, rather we had target ranges for calories, Na, carbohydrates and saturated fat. We aimed for the following parameters for each serving: 45–60 g of carbohydrates, 400–500 calories, variety and balance of food groups (whole grains, fruits, non-starchy vegetables, lean proteins, low-fat dairy), adequate fibre and moderate or low in saturated fat and Na.While people with dietary restrictions that could not be accommodated were excluded, recipes were adapted to meet some specific needs. Eighty-five percentage of participants received the standard Western diet recipes, with the remaining participants receiving gluten-free (6 %, | PMC10564597 | |
Recipe measures | To examine recipe acceptability, appropriateness and adoption, we used responses collected from the exit survey to describe whether participants used study recipes (yes/no), how many found the recipes useful (not useful at all, somewhat useful, very useful) and which recipes were the most used and liked. Response options included: I did not receive this recipe, I did not make this recipe, I did not like at all, I liked a little, I liked somewhat and I liked a lot. We also evaluated willingness to use recipes in the future (yes/no). Measures were calculated for all participants and by study group. | PMC10564597 | ||
Online grocery shopping measures | To assess online grocery shopping fidelity food receipt forms were coded to determine how many of the intervention weeks participants in the Online and Defaults groups used the online grocery platform as requested. To measure acceptability, participants rated their online shopping experience as Excellent, Good, OK, or Poor in the exit survey. We also evaluated willingness to use online grocery shopping carts in the future (yes/no). | PMC10564597 | ||
Defaults group measures | Research staff and participants both had access to the participants’ online grocery shopping accounts. Participants’ financial information was encrypted and inaccessible to research staff, but they had access to all other functionality and would use the shared account to prepopulate a grocery cart with default items that aligned with the DASH diet and study recipes for each week. Four to nine default ingredients were added to the participants’ carts each week.For a measure of intervention integrity, participants in the Defaults group were asked if they saw the prefilled carts in the online grocery shopping platform (yes/no) in the exit survey. To measure intervention acceptance and appropriateness, exit surveys included an item on whether Defaults participants found the prefilled carts to be useful (not useful at all, somewhat useful, very useful). Research assistants independently double-coded the food receipt data to determine if the Defaults group purchased none (0), some (1) or all (2) of the default items placed into their online shopping carts. For an item to be considered an accepted default, the item had to be accepted exactly as is without modification. For example, if a participant substituted a 16-oz orange juice for a 64-oz orange juice, it was not considered an acceptance of the default, given the participant would have made a modification. Once research assistants coded the receipts, discrepancies were reconciled by a third reviewer, and proportions were calculated to determine the percentage of the sample purchasing none, some or all default items placed into the online shopping carts by week and by recipe. We also evaluated willingness to use prefilled grocery shopping carts in the future (yes/no). | PMC10564597 | ||
Open-ended exit survey items | There were four open-ended response items in the exit survey; participants were not required to answer these items. The questions and response rates were: (1) After participants rated their online shopping experience, they were asked ‘Please tell us why you chose the response that you did’ ( | PMC10564597 | ||
Data analysis | Descriptive statistics were calculated using frequencies and proportions for categorical variables. Fisher’s exact tests were used to identify if there were group differences in recipe use, recipe usefulness, willingness to use recipes and online grocery shopping in the future. Inductive thematic analysis (familiarisation, coding, defining themes) was used to summarise feedback from open-ended survey responses regarding recipes, online grocery shopping and what participants would change about the study in the future to contextualise quantitative results. | PMC10564597 | ||
Study payment | Participants were paid up to $75 using a reloadable debit card as they completed study tasks: $20 after completing baseline measures, $10 after each week of intervention measures and another $25 for completing the exit survey. | PMC10564597 | ||
Results | PMC10564597 | |||
Participant characteristics | Among the sixty-five randomised participants in the analytic sample, participants were predominantly female (85 %), college graduates (70 %) and white (92 %). Annual household income varied, with 20 % below $50 000 USD, 47 % between $50 000 and$74 999 USD, 28 % above $100 000 USD and 5 % choosing not to say. Thirty-one percentage of participants reported having at least one child under 18 in the household and 75 % had at least one other adult in the home for an average household size of 2·5 people ± 1·3. Participants’ mean age was 53·2 years old ± 10·7, and mean BMI (calculated using participants’ self-reported height and weight) was 36·5 ± 7·8. We did not ask participants if they typically grocery shopped online in the baseline questionnaire, given that doing most of one’s grocery shopping in-person at the time of screening was an inclusion criterion, but did note that three participants (5 %) submitted online grocery receipts in the Week One (baseline) receipt collection. More information about baseline food purchasing behaviour can be found in Table
Food purchasing behaviour from baseline questionnaireValues in columns are | PMC10564597 | ||
Recipe results: fidelity, acceptability, appropriateness, adoption | Recipe use differed by group, such that participants in the Defaults group were more likely to report using study recipes (86 %) than participants in the Control (47 %) and Online groups (57 %), Fisher’s
Reported use and usefulness of study recipes via online exit survey post-intervention (Fisher’s = Fisher’s exact test, a chi-square variation that accounts for small cell sizes.These questions were asked among the forty participants who used study recipes. Values in columns are
Participants use and liking of study recipes by recipe (W, Western; GF, gluten-free; K, Kosher; V, vegetarian.Values in columns are
The most frequent positive feedback on study recipes was that they were easy to follow. Across all groups, participants received three recipes per week, and some articulated a desire to receive more. Some participants expressed specific recipes and food items (e.g. lentils, quinoa) did not fit with their preferences or their family’s preferences which limited usefulness of those recipes, ‘ | PMC10564597 | ||
Online grocery shopping results: fidelity, acceptability, appropriateness, adoption | Of the participants that reported grocery shopping online during the study period (
Participants’ in-person and online grocery shopping by groupValues in columns are | PMC10564597 | ||
Barriers of online shopping | In the primary outcomes paper for the overarching study, the research team reported that average dollars spent at study grocery stores did not differ between group | PMC10564597 | ||
Benefits of online shopping | The most frequently cited benefits of online grocery shopping were time saved and convenience. One participant wrote ‘ | PMC10564597 | ||
Defaults results: fidelity, acceptability, appropriateness, adoption | Among Defaults participants that completed an exit survey, all twenty-one indicated they saw the prefilled grocery cart while shopping (100 %). The recipes with the highest default acceptance were pasta and grilled chicken (81 %), chicken quesadillas with black beans (84 %) and grilled chicken with olives (90 %). Table
Defaults group acceptance of default items by recipe and weekW, Western; GF, gluten-free; K, Kosher; V, vegetarian.Values in columns are Kosher participant would have received these recipes but skipped Week 4; no participants accepted all default items. | PMC10564597 | ||
What participants would change about the study | The most frequently recommended change was an amendment to the food receipt form to make it quicker and easier to detail and submit information on grocery purchases. Multiple participants indicated that the forms were not ‘user-friendly’. The second most frequently mentioned change was providing additional recipes to allow more flexibility and choice in the recipes and default items received. | PMC10564597 | ||
Discussion | diabetes | TYPE 2 DIABETES, SHOP, DIABETES | Findings from this study suggest that it was feasible to implement an optimal defaults intervention to improve the nutritional quality of grocery purchases for people with or at-risk for diabetesFifty-five (83 %) of our participants had complete protocol adherence, including submitting receipts across all study weeks. A strength of this study is the high rate of participant compliance and retention, though findings should be replicated in longer, larger studies. A systematic review of 174 longitudinal cohort studies reported that ‘flexibility in data collection methods might be most effective in maximizing retention’A limitation of this study is the homogeneity of the sample, which is predominantly white and college educated. There are several ways to open eligibility criteria in the future to improve heterogeneity. Given that 25 % of people that completed the eligibility screener were excluded for not shopping at one of the study stores, future research could modify or extend the stores that are included, with an eye towards stores in under-resourced neighbourhoods. In the present study, two of the largest grocery chains in the researchers’ geographic area were selected as study stores, to broaden external validity to the extent possible for a pilot study. That decision also helped with the feasibility of filling default grocery shopping carts. Since the design of this study, additional grocery stores are available on the online grocery platform used in this study, offering the potential to include other study stores in the future.In addition, 134 people that completed the eligibility screener were excluded for receiving SNAP/WIC benefits. At the time this study was designed, the grocery platform used for this study did not accept electronic benefits as a form of payment and therefore the research team did not want to recruit participants that may not be able to shop online. Since then, SNAP purchasing pilots have expanded, and many retailers are approved to accept SNAP onlineFood purchases are an antecedent to food consumption and are strongly correlated with diet qualityAbout 65 % of participants used study recipes, with greater usage in the Defaults group, in which 86 % reported using recipes. Nutrition and cooking education is a widely used strategy to improve dietary outcomes for people with or at-risk for diabetes and one of the best known examples is the diabetes prevention programMost participants in the Defaults group accepted at least one of the ingredients in the default carts each week (82–95 %) which also suggests that the intervention may be acceptable to participants. Out of the standard recipes, acceptance was highest for whole grain pasta and grilled chicken, chicken quesadillas and grilled chicken and olives. Researchers interested in conducting a similar study could use the study recipes most liked by participants (Table Most participants in the Online and Defaults groups were compliant and shopped online, though some continued to supplement online shopping with in-person shopping, and not all participants liked shopping online. One participant dropped out of the study because they did not want to shop online, and of those who shopped online during the study, 28 % indicated they did not plan to shop online in the future. While online grocery shopping is expected to continue to growThe most frequent complaint from participants was challenges with the food receipt form, the tool used to collect food purchasing details that may not be included on a receipt (e.g. product weight, size, quantity or brand). Potential solutions could include partnering with an online platform to see the exact product(s) participants purchased or using food tracking or grocery shopping applications that allow participants to scan barcodes and create food diaries or shopping lists from their purchases, which may be more user-friendly. This study highlights the need for technological and practical advancements that improve the process of collecting purchasing data from participants and reduce the time it takes for study staff to conduct nutritional analysis of receipt data, not just for studies of grocery defaults, but to benefit the broader food purchasing literature.In this pilot randomised controlled trial, we found that an optimal defaults intervention aiming to improve grocery purchases using prefilled default grocery carts is an acceptable, feasible and desirable intervention for many people with or at-risk for type 2 diabetes. Using the lessons learned from this study, extension of this research may include expanding inclusion criteria to recruit a more heterogeneous sample, providing participants with more recipe options, prepopulating default carts with items that may be more desirable to participants and members of their household and streamlining the process for collecting detailed receipt data. Future research could increase the study period beyond 5 weeks to identify whether compliance and retention remain high over longer periods of time and whether long-term dietary change is possible. Implementing recommendations identified in this pilot study may increase the likelihood of continued adherence to the study protocol and defaults recommendations. | PMC10564597 |
Acknowledgements | BRADLEY, RECRUITMENT | The University at Buffalo Clinical and Translational Science Institute assisted with participant recruitment efforts, and Rocco Paluch, MS, assisted with participant randomisation. The study team would like to thank postdoctoral fellow, Mackenzie Ferrante, PhD, RDN, for overseeing coding of default cart acceptance data, research assistant Lindsay Lassetter for her assistance to the Study Coordinator and research assistants who contributed to data coding for this study, including Hannah Anderson, Adrianna Calabro, Courtney Cole, Claire Filipowicz, Vaishali Gupta, Olivia Hopko, Opeyemi Ibitayo, Elizabeth Johnson, Ariana Khan, Cindy Le, Andrea Less, Hannah Mwelwa and Bradley Rao. We would also like to thank the study participants. | PMC10564597 | |
Financial support | Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under award number UL1TR001412 to the University at Buffalo. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. | PMC10564597 | ||
Conflicts of interest | The authors have no conflicts of interest to declare. | PMC10564597 | ||
Authorship | S. A. F. led conceptualisation of the overarching study, with K. H. H., L. M., L. H. E., L. A. L. and E. M. contributing to study design, and K. H. H. and S. A. F. leading the plan for this implementation manuscript. K. H. H. led manuscript preparation and conducted data analyses, and S. A. F. obtained study funding and conducted data analyses. S. T., L. L., S. B., L. M. and J. D. contributed to data collection and led the preparation of a scientific poster that presented a subset of related results at the 2021 Society for the Study of Ingestive Behavior Annual Meeting. J. M. served as the study dietitian during study design, contributing especially to the generation of intervention materials (i.e. study recipes). All authors provided critical feedback on the manuscript and approved the final version. | PMC10564597 | ||
Ethics of human subject participation | This study was conducted according to the guidelines laid down in the Declaration of Helsinki and all procedures involving research study participants were approved by the University at Buffalo Institutional Review Board (STUDY00003054) and the study was pre-registered at clinicaltrials.gov (NCT04051008). Informed consent was obtained from all subjects electronically. | PMC10564597 | ||
References | PMC10564597 | |||
Abstract | PMC10498078 | |||
Background | Due to the Covid‐19 pandemic lockdown during the online‐distant education period, certain students tended to combine their courses and homework with TV or social media news or other media content, such as classical music, including a wealth of audio and audiovisual stimuli. As the audio and audiovisual stimuli existing in a learning environment may affect students' autonomic nervous system (ANS) responses negatively, the present study aimed to monitor the impact of background TV, classical music, and silence on students' ANS activity represented by heart rate (HR), heart rate variability (HRV), blood volume amplitude (BVA), and skin conductance level (SCL) during and after an experimental academic examination. | PMC10498078 | ||
Method | Seventy‐six students were randomly allocated to background TV, classical music, or silence groups. The experiment with repeated measures design consisted of four consecutive periods: baseline, anticipation, challenge, and recovery, lasting 4 min each. | PMC10498078 | ||
Results | Within‐subject analyses indicated significant HRV decrement only in the background TV group. Regardless of the experimental groups, HR and SCL increased while BVA decreased during the task. In addition, the between‐subject analysis showed that the background TV group experienced significantly larger changes in HR and HRV parameters compared to the other experimental groups relative to their respective baseline measurements. | PMC10498078 | ||
Conclusions | HEART | Based on these results, we concluded that relative to classical music and silence, background TV, including audiovisual and verbal stimuli, extant in a learning environment might raise students' sympathetic activity. Further, classical music, without lyrics, may suppress the withdrawal of vagal activity and elevate the autonomic regulation capacity during the academic reading comprehension task. HRV is a more valid and reliable indicator of students' autonomic responses during a challenging academic task.Background TV existing in a learning environment might give rise to a decrement in heart rate variability during an experimental academic examination. Classical music elevate the autonomic regulation capacity during the academic reading comprehension task. Heart rate, blood volume amplitude, skin conductance level, and heart rate variability might not be equally sensitive indices to environmental audio and audiovisual stimuli.
| PMC10498078 | |
INTRODUCTION | visual and auditory, worry, anxiety | STRESSFUL EVENTS | Students face many challenges throughout their academic careers, such as examinations, harsh course content, and relations with teachers. The learning environment, which includes various dimensions such as the school buildings themselves, classrooms, the materials used for instruction, and interactions between students and teachers, can also be another severe challenge for students and might impact several variables. Previous research documented that the learning environment might affect certain outcome variables such as self‐efficacy (Dorman, Due to technological developments, traditional components of learning environments have started to evolve. In this respect, most students have smart devices that can considerably alter audio and audiovisual stimuli extant in their learning environment (Dixit et al., The ANS controls many of the body's involuntary functions, including heart rate (HR), blood pressure, digestion, breathing, sexual arousal, papilla reflex, and stress responses (Gibbons, Due to the probable impact of background music on ANS, individuals could choose to listen to music while studying. Despite the popularity of pop music among people of different ages and nationalities while studying (Kotsopoulou & Hallam, Background television may be the other most common way to create a learning environment used by students. Moreover, today almost every individual has access to smart devices that can act similar to television, such as digital video streaming platforms. More importantly, during the Covid‐19 lockdown period, the use of smart devices and televisions increased dramatically, especially in Western societies. Television broadcasts may transmit both visual and auditory information; hence, they may significantly impact students' autonomic responses. Moreover, the messages sent by a television broadcast include specific structural elements such as luminance, slow motion, cuts, animation, and music (Lang, In addition to the limited capacity approach mentioned earlier, the orienting response may be another valuable theoretical framework that can explain whether a learning environment's background sound characteristics may lead to variation in psychophysiological activity. The term orienting response describes the automatic allocation of information processing resources to the television program as a novel or exciting stimulus (Pool et al., It is widely recognized that cognitive workload affects the variability of autonomic activity. However, relying solely on one ANS marker may not provide sufficient insight into this connection. To gain a better understanding of the correlation between cognitive workload and ANS activity, it is best to measure several psychophysiological biomarkers that can indicate the performance of both the sympathetic and parasympathetic branches of ANS. In this regard, previous research provided evidence for the idea that heart rate (HR), heart rate variability (HRV), blood volume pulse amplitude (BVA), and skin conductance level (SCL) might reflect changes in ANS activity stemming from the cognitive workload, stressful events, anxiety, and worry (Critchley, HRV is one of the noninvasive electrocardiographic (ECG) parameters that reflects the autonomic control of the heart (Heffernan et al., Another noninvasive indicator of the autonomic activity implemented in the present study is the blood volume pulse (BVP). BVP is considered a parameter that can reflect a peripheral pulse waveform converted to blood volume pulse amplitude (BVA) (Lin et al., SCL is another widely used marker of the sympathetic branch of the ANS. SCL reflects only sympathetic activity. SCL refers to the variation of the electrical properties of the skin in response to sweat secretion (Benedek & Kaernbach, In the present study, we aimed to explore the effect of background TV, classical music, and silence on students' autonomic responses, represented by HR, HRV, BVA, and SCL before, during, and after an experimental academic examination. To the best of our knowledge, no previous study tested whether learning environments with differing audio and audiovisual stimuli may lead to a variation in autonomic activity. Also, the present study implemented several standard psychophysiological biomarkers recorded from different anatomical regions (peripheral measures of the ANS). Therefore, the present study's results can provide an opportunity to better understand students' autonomic responses during a demanding academic task in the presence of differing audio and audiovisual stimuli.In light of the theoretical explanations and research findings cited above, we predicted that the learning environment with background TV should increase HR. We also predicted that background TV reduces BVA and increases SCL levels. We further hypothesized that silence and background classical music do not affect individuals' HR, HRV, BVA, and SCL. In other words, classical music should act like silence during the mental task. We specifically reached this hypothesis due to above‐cited references showing the inconsistencies concerning the classical music's effect on ANS and mental performance. We also postulated that changes in HR, HRV, BVA, and SCL during the anticipation, challenge, and recovery should be greater in the background TV group. | PMC10498078 |
METHODS | PMC10498078 | |||
Participants | Seventy‐six first‐year undergraduate students (35 female) ranging in age from 19 to 24 ( | PMC10498078 | ||
Measures | PMC10498078 | |||
Measurement and psychophysiological data | A NeXus‐10 device, its supplied software of BioTrace | PMC10498078 | ||
Analysis of HR, HRV, and data reduction | The HR and HRV of each participant were obtained based on the time series of peak‐to‐peak intervals immediately extracted from the BVP data. The HR and HRV are computed by taking the peak‐to‐peak distances between beats. Before analyses, we visually checked the normal‐to‐normal intervals (NN intervals), movement artifacts, and unusual heartbeats for artifact rejection. Afterward, we used the NeXus‐10 device‐supplied software BioTraceThe HRV time domain was represented in the present study by the SDNN (ms) and the RMSSD (ms). We calculated the frequency‐domain parameters using the FFT algorithm (FFT window length = 512, Hanning window, 1024 points). As mentioned above, the primary HRV frequency‐domain indices are the LF (ms | PMC10498078 | ||
Blood volume amplitude analysis | The BVA was derived from the raw BVP signal via a PPG sensor and accepted to indicate changes in blood volume in arteries and capillaries. The PPG signal represents an average of all blood volume in the arteries and capillaries. The data were sampled at 1024 Hz and were expressed in millivolt (mV). | PMC10498078 | ||
Skin conductance level analysis | For the analysis, the mean SCL was determined over the experimental periods. Mean SCL was computed on BioTrace | PMC10498078 | ||
Experimental procedure | affecting nervous system functioning | The first author conducted all experiments in a particular room designed specifically for the present study (Figure (a) Schematic representation of the experimental setup and (b) diagram of the experimental procedure.Participants were required to abstain from using medications affecting nervous system functioning for the study duration. Participants were told not to consume alcoholic drinks for 48 h and caffeinated drinks for 2 h before the experiment. Participants were also asked not to smoke for 2 h before the experiment. On arrival at the laboratory, participants were randomly assigned to one of the three groups: classical music ( | PMC10498078 | |
Baseline period | In the experiment's first period, the participants' baseline autonomic indices were recorded for 4 min while sitting at rest. During this period, participants were asked not to talk and move. | PMC10498078 | ||
Anticipation period | At the beginning of the anticipation period, the experimenter explained the experimental procedure and the tasks. Accordingly, participants were told that there would be a history exam, and the individual exam scores would be publicized via faculty notice boards, intranet, and experimenters' social media accounts. Participants were then asked to choose one of the four identical envelopes containing 750‐word history essays. The participants were instructed to read and understand the 750‐word essay in the 4 min allocated while their autonomic responses were recorded. In this period, the classical music group was exposed to Johann Sebastian Bach's Orchestral Suite No. 3 in D major. The background TV group was exposed to the ATV channel's main news bulletin. We exposed participants to classical music and TV via an audio system placed at the four corners of the room, and a 127 cm TV placed 4 m in front of the participants, respectively. In both conditions, the sound level was 70 dBA. The silence group received no background sound intervention over the course of the entire experiment. Participants in all groups were not allowed to take notes during the anticipation period. | PMC10498078 | ||
Challenge period | At the end of the anticipation task, the experimenter took the essay back and gave the participant a standard examination paper consisting of 15 questions. Participants were instructed to answer all questions in the 4 min allocated while their autonomic responses were measured. Based on a pilot study of 10 students, we determined that it takes approximately 10 min to answer the 15 questions. As in the anticipation period, the classical music, background TV, and silence groups were exposed to the same background sound interventions during the challenge period. | PMC10498078 | ||
Recovery period | In the final period of the experiment, the experimenter ended the background sound intervention for the classical music and background TV groups, instructed participants to rest for 4 min, and subsequently recorded the autonomic responses during the recovery period. | PMC10498078 | ||
Statistical analysis | To analyze the obtained data set, we first log‐transformed (Log 10) the HRV frequency‐domain parameters to satisfy linear analysis requirements. Then, we conducted a series of repeated measures ANOVAs to explore whether HR, HRV, BVA, and SCL responses differed significantly between the baseline, anticipation, challenge, and recovery conditions in the experimental groups with different sound environments. In reporting repeated measures ANOVA, we used a corrected degree of freedom via Greenhouse–Geisser estimates of sphericity if the assumption of sphericity was violated. Paired sample | PMC10498078 | ||
RESULTS | PMC10498078 | |||
Results of the within‐subject analysis | PMC10498078 | |||
HR, HRV indices, BVA, and SCL changes in the background TV group | The results of repeated measures ANOVA demonstrated that HR (F (3, 75) = 44.97, The repeated measures ANOVA and multiple comparison tests with Bonferroni correction for autonomic indices in the background TV group.
Abbreviations: a, comparison of baseline and anticipation conditions; b, comparison of baseline and challenge conditions; c, comparison of baseline and recovery conditions; d, comparison of anticipation and challenge conditions; e, comparison of anticipation and recovery conditions; f, comparison of challenge and recovery conditions.HR, SDNN, RMSSD, Log LF, and Log HF changes in all experimental groups. (a) HR changes, (b) SDNN, (c) RMSSD, (d) Log LF changes, (e) Log HF changes during the experiment for the background TV, classical music, and silence (control) group. *BVA and SCL changes in all experimental groups. (a) BVA changes, (b) SCL changes during the experiment for the background TV, classical music, and silence (control) group. * | PMC10498078 | ||
HR, HRV indices, BVA, and SCL changes in the classical music group | The repeated measures ANOVA revealed that HR (F (1.91, 44.01) = 11.36, The repeated measures ANOVA and multiple comparison tests with Bonferroni correction for autonomic indices in the classical music group.
Abbreviations: a, comparison of baseline and anticipation conditions; b, comparison of baseline and challenge conditions; c, comparison of baseline and recovery conditions; d, comparison of anticipation and challenge conditions; e, comparison of anticipation and recovery conditions; f, comparison of challenge and recovery conditions. | PMC10498078 | ||
HR, HRV indices, BVA, and SCL changes in the silence group | The repeated measures ANOVA indicated that HR (F(3, 75) = 25.07, The repeated measures ANOVA and multiple comparison tests with Bonferroni correction for autonomic indices in the silence (control) group.
Abbreviations: a, comparison of baseline and anticipation conditions; b, comparison of baseline and challenge conditions; c, comparison of baseline and recovery conditions; d, comparison of anticipation and challenge conditions; e, comparison of anticipation and recovery conditions; f, comparison of challenge and recovery conditions. | PMC10498078 | ||
Results of the between‐subject analysis | In addition to within‐subject comparison, we tested whether changes in physiological parameters during anticipation, challenge, and recovery differed significantly among the experimental groups. For this purpose, we first calculated how much physiological parameters deviated from their baseline measures. Then, we performed a series of one‐way ANOVAs to explore whether changes in these values differed between the background TV, classical music, and silence groups. As illustrated in Table One‐way ANOVA of change scores of psychophysiological indices among the anticipation, challenge, and recovery periods.
HR, SDNN, RMSSD, and Log HF changes in all experimental groups. (a) HR changes, (b) SDNN, (c) RMSSD, (d) Log HF changes during the experiment for the background TV, classical music, and silence (control) group. * | PMC10498078 | ||
DISCUSSION | respiratory sinus arrhythmia, Laborde et al., This novel study, anxiety, autonomous nervous systems | DILATION, CONTRACTION | The present study investigated whether a learning environment with a background TV, classical music, or just silence may affect students' ANS activity represented by HR, HRV, BVA, and SCL during and after an experimental academic examination. We found that HR, BVA, and SCL differed significantly among the experimental conditions in all groups. In contrast, HRV time‐domain parameters showed significant differences in the group with the background TV. This group had to process more cognitive information such as audio, audiovisual stimuli, and verbal content. However, HRV parameters remained relatively stable in the groups that listened to classical music or experienced silence. The data partially supported our hypothesis concerning differences in changes in psychophysiological parameters during academic examination. Thus, differences in HR and HRV were more remarkable in the background TV group only during the anticipation period.In previous studies, researchers focused primarily on whether a learning environment with a background TV might influence homework performance or achievement (Pool et al., 2000, The results also demonstrated a decrease in BVA, which reflects arterial dilation and contraction that are controlled by autonomous nervous systems (Lin et al., Another critical issue that we want to highlight is the progression of HRV responses to background TV intervention. As illustrated in Figure In contrast to the HRV decrement observed as a result of the within‐subject comparisons in the background TV group, HRV time‐ and frequency‐domain indices remained almost stable in the background classical music and silence group. These results provided preliminary support for the view that the HRV decrement observed in the background TV group was due to individuals' efforts devoted to filtering out the irrelevant stimulus generated by the TV. It is important to note that the results showed a remarkable vagal withdrawal in the group with background TV. These results could be attributed to the presence of verbal stimuli, which were absent in the groups listening to classical music and experienced silence. Hence, the lyrics of musical pieces might influence how music affects psychophysiological activity during a demanding mental task.As stated earlier in this paper, individuals may believe that listening to classical music while studying lessons may benefit a better learning outcome. However, functional MR and PET studies showed that brain regions associated with the control of attention, memory, working memory, emotion, and the limbic system also engage in processing musical auditory information (Salimpoor et al., Contrary to HRV parameters, HR, and SCL increased and BVA decreased significantly during anticipation and challenge periods in the classical music and silence groups, which means that sympathetic activity has been promoted by our intervention. These results indicated that HRV might be influenced by the severe audiovisual stimulus in contrast to HR, BVA, and SCL. Taken together, based on the results of the present study, especially the decrement in RMSSD and Log HF, we concluded that background TV is a severe stressor that can alter autonomic activity. Moreover, the current study results supported the view that HRV is a valid indicator of psychological and environmental stress, emotional states, and mental challenge (Appelhans & Luecken, The last finding we want to discuss is the relatively stable progress of the LF/HF ratio in all experimental groups. Although our results, in general, indicated a parasympathetic withdrawal and sympathetic elevation, LF/HF ratio which is accepted as sympathovagal balance indice (Laborde et al., This novel study may have some implications for both practitioners and researchers. First, future researchers aiming to understand the effect of background distracting audio and audiovisual stimulus on ANS activity should consider the possibility that HR, HRV, BVA, and SCL are not equally sensitive to distracting stimuli during a demanding mental task. Therefore, we recommend recording several standard psychophysiological biomarkers for a better understanding of the issue. Further, considering the possibility that different participants might tend to respond to stress by activating different major physiological systems (Lacey, The present study has some limitations. In the present study, we did not measure perceived stress in addition to objectively measured stress. Also, we did not measure participants’ perceived state anxiety and difficulty concerning the task. Our study focused solely on the influence of classical music without lyrics in the background. However, previous research indicates that the effect of background music may vary depending on whether it includes lyrics. Therefore, future studies should explore the effects of background music with and without lyrics. Finally, in this study, respiration activity was not monitored and controlled. So, given that the breathing pattern may affect HRV, especially HF power (due to respiratory sinus arrhythmia) (Quintana & Heathers, | PMC10498078 |
CONCLUSION | Results of the present study indicated that classical music and silence gave rise to almost similar responses in terms of recorded psychophysiological biomarkers which means that classical music has at least null effects during a mental task. Rather, a certain type of music especially calm music with no lyrics might speed up tonic vagal activity and increase autonomic regulation capacity in reading comprehension tasks. Students might benefit from Johann Sebastian Bach's classical music composition of Orchestral Suite No. 3 in D major while engaging in a demanding reading comprehension task. We also concluded that the impact of music or other background audio and audiovisual stimuli may be influenced by the presence of verbal contents in those stimuli. In this respect, the background TV having audio, audiovisual stimuli, and more critically verbal content that can interfere with reading tasks might suppress vagal activity. Finally, the HR, HRV, BVA, and SCL methods are not equally sensitive mediums to indexing ANS activity in a learning environment. In this regard, HRV may represent students' sympathetic and parasympathetic activity only when they are exposed to severe stimuli during a cognitive task. Studies executed with SCL and BVA may give more precise results if performed with HRV. | PMC10498078 | ||
AUTHOR CONTRIBUTIONS | İlker Balıkçı, Serdar Tok, and Erdal Binboğa were all involved in the design, writing, and editing of the study and manuscript. All authors approved the final version for submission. | PMC10498078 | ||
CONFLICT OF INTEREST STATEMENT | The authors declare no conflicts of interest. | PMC10498078 | ||
FUNDING INFORMATION | The authors did not receive support from any organization for the submitted work. | PMC10498078 | ||
PEER REVIEW | The peer review history for this article is available at | PMC10498078 | ||
ACKNOWLEDGMENTS | The authors wish to thank all the students who participated in the study. We are also grateful to Ege University Planning and Monitoring Coordination of Organizational Development, and the Directorate of Library and Documentation for their support in editing and proofreading service of this study. | PMC10498078 | ||
DATA AVAILABILITY STATEMENT | The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10498078 | ||
REFERENCES | PMC10498078 | |||
Abstract | PMC10728525 | |||
Objectives | CAVITY | Maxillomandibular fixation requires the jawbones to remain static. Mechanical cleaning is also carried out by brushing or with a water flosser to maintain the oral cavity in a hygienic state, but this cannot be considered sufficient. Mouthwashes are used as a substitute for mechanical cleaning or in a supplementary role after such cleaning. The aim is to evaluate the effectiveness of HABITPRO mouthwash, which contains cetylpyridinium chloride, dipotassium glycyrrhizinate, and tranexamic acid in the specific environment created by maxillomandibular fixation used as an adjunct to mechanical cleaning. | PMC10728525 | |
Material and Methods | A total of 55 patients who had undergone maxillomandibular fixation were randomly allocated to either a HABITPRO group ( | PMC10728525 | ||
Results | After approximately 2–3 weeks of mouthwash use, the PCR index also increased significantly in the placebo group compared with baseline, whereas it remained almost steady in the HABITPRO group. Additionally, salivary ammonia levels decreased significantly in the HABITPRO group compared to that of the placebo group. | PMC10728525 | ||
Conclusions | Even with maxillomandibular fixation, continued gargling with HABITPRO mouthwash in the perioperative period as an adjunct to mechanical cleaning can help maintain better oral hygiene and reduce bacterial counts.
| PMC10728525 | ||
INTRODUCTION | Stomatitis, bleeding, diarrhea, stomatitis, caries, pain, mandibular fracture | STOMATITIS, BLEEDING, STOMATITIS, PERIODONTITIS, WOUND INFECTION, DENTAL PLAQUE, CARIES, COMPLICATION, POSTOPERATIVE INFECTION, BACTERIAL RESISTANCE, CAVITY, SECONDARY INFECTION | It has long been known that the oral cavity is a breeding ground for bacteria, because it is not only maintained at a constant temperature, but it is also a moist environment (Aas et al., Under normal circumstances when homeostasis is maintained, individuals are able to coexist with the commensal resident intraoral biota by means of their own immunity and natural purification. However, diminished immunity in the periprocedural period (whether the procedure involves surgery, radiotherapy, chemotherapy, or other treatment) or due to age means that homeostasis can no longer be maintained, and a range of problems can occur, including wound infection, stomatitis and resulting secondary infection, caries, and periodontitis. Stomatitis is a particular issue during radiotherapy and chemotherapy, and since it causes bleeding and pain, mechanical cleaning becomes difficult (Saadeh, Special conditions caused by surgery are also known to affect the oral environment in various ways. For example, patients with a mandibular fracture and those who have undergone orthognathic surgery may undergo maxillomandibular fixation to encourage bony healing, but this means that they are unable to open their mouths and cannot eat by mouth for a certain period. The most common complication after these surgeries is postoperative infection. Antimicrobial administration plays an important role in the prevention of postoperative infections, but carries the risk of diarrhea and the increasing bacterial resistance (Thornhill et al., HABITPRO mouthwash contains the following three active ingredients: cetylpyridinium chloride (CPC), dipotassium glycyrrhizinate (GK2), and tranexamic acid (TXA), which are expected to have bactericidal, anti‐inflammatory, and hemostatic effects.The objective of this study was to investigate the effect of continued perioperative use of HABITPRO mouthwash with mechanical cleaning on the intraoral environment, particularly in patients undergoing maxillomandibular fixation, which is a specific treatment used in dental and oral surgery. Specifically, the intraoral environment was evaluated by testing the amount of dental plaque and salivary properties to investigate the effectiveness of this mouthwash during maxillomandibular fixation. | PMC10728525 |
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