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RESULTS | PMC10802776 | |||
Description of the population | The first subject was enrolled, randomized, and assessed on January 13, 2020; the
last subject was screened on July 22, 2020 (
Enrollment, randomization, and follow-up regarding the effect of
vertical positioning on lung aeration.The baseline characteristics of the participants are shown in Baseline characteristics | PMC10802776 | ||
Primary outcome | LUNG | The LUS values across different study time points are shown in Study outcomesLung ultrasound score in different postures
Lung ultrasound score across different verticalization
interventions.
Lung ultrasound scores of patients receiving invasive mechanical
ventilation through an endotracheal tube in different postures. | PMC10802776 | |
Secondary outcomes | hypotension, orthostasis, SD, tachycardia | ADVERSE EVENTS | The median tidal volumes for passive orthostasis and the sitting position were
436mL (IQR 395 - 507) and 435mL (IQR 380 - 480), respectively (p = 0.47). The
mean respiratory rates for passive orthostasis and the sitting position were
24.7 (SD 6.1) and 24.2 (SD 6.0), respectively (MD -0.47; 95%CI - 4.1 - 3.1; p =
0.78). The median minute volumes for passive orthostasis and the sitting
position were 10.3L/minute (IQR 8.7 - 12.5) and 11.1L/minute (IQR 8.4-12.2),
respectively (p = 0.42). There was no difference in the median number of
professionals required to perform the passive orthostasis and sitting position
protocols (passive orthostasis: 3.0; IQR 3 - 3; sitting position: 3.0; IQR 3 -
3.2; p = 0.40) (At the time the protocol was performed, four adverse events (11%) occurred
related to the safety of the interventions. One episode of tachycardia occurred
during passive orthostasis and three episodes of hypotension occurred (two
during passive orthostasis and one while in the sitting position). The number of
patients who experienced adverse events did not differ significantly between
protocols (p = 0.99) ( | PMC10802776 |
Feasibility | RECRUITMENT | There were no significant protocol deviations during the study regarding
recruitment procedures, informed consent, intervention administration, or
outcome assessment. All included subjects met all the inclusion criteria, and
none had any exclusion conditions. Informed consent was obtained from all
participants. Although the administration of both interventions was not possible
for two subjects, the reason was related to study logistics in only one patient
(5%). The washout period was completed for all subjects, and last, there were no
missing values for the primary outcome (with the exception of the two
participants who did not complete both interventions). | PMC10802776 | |
DISCUSSION | critically ill, orthostasis | ADVERSE EVENTS, CRITICALLY ILL | The present crossover randomized clinical trial comparing the effect of passive
orthostasis using a tilt-table with a standard sitting position on lung aeration in
mechanically ventilated critical care patients found no difference between the
interventions. Although no difference in lung aeration was found between the
interventions, we cannot rule out the benefits or harms of passive orthostasis using
an orthostatic board. This is due to the inclusion of a smaller sample size than
needed to accept or refute our hypothesis. Thus, it does not provide sufficient
statistical power for definitive conclusions.The ventilatory benefits of vertical positioning in increasing the end-expiratory
lung volume and oxygenation of patients receiving IMV have already been
demonstrated.In the same context of mobilizing patients receiving IMV and assessing lung aeration,
Hickmann et al.We believe that the main factors involved in the lack of difference in lung aeration
between chest verticalization positions were as follows: first, the low power of the
present analysis due to the low number of participants might be associated with type
II error. The significant 95%CI found in the primary outcome analysis does not
exclude a benefit of passive orthostasis for lung aeration. Second, subjects showed
a median LUS of 10 points at baseline. Although the LUS does not have a cutoff point
for all populations and situations, Soummer et al.It has been shown that having a small number of multiprofessional staff members is a
constraint on the mobilization of critically ill patients.Our study had a higher rate of adverse events than reported in a large portion of the
literature.To the best of our knowledge, this is the first study to evaluate lung aeration in
different vertical positions by using the LUS in patients receiving IMV. Studies
using the LUS during vertical positioning in patients receiving other ventilation
support, such as high-flow nasal cannula (HFNC), noninvasive ventilation (NIV) or
IMV by tracheostomy, and evaluating the need for ventilatory support due to
pulmonary or extrapulmonary causes may bring new knowledge to clinical practice.Some limitations must be considered. First, just over 50% of the sample target was
met; however, the early interruption of the study was necessary due to the health
reality imposed by the COVID-19 pandemic. Second, assessment blinding was not
performed, and some evaluators were involved with the study, which may have led to
measurement bias. Third, in addition to the small sample, the study was limited to 2
hospitals, which may limit the external validity in other contexts. Fourth, the
study design may have led to a carry-over effect. Fifth, we cannot rule out temporal
alterations in the patients’ conditions, inherent to the clinical practice of the
intensive care environment. | PMC10802776 |
CONCLUSION | orthostasis | Considering the findings, our study does not allow us to draw generalized
conclusions. Even so, we speculate that the verticalization of the chest performed
through sitting and passive orthostasis positioning does not generate changes in
lung aeration, as assessed by ultrasound. We emphasize that such findings need to be
confirmed by a study with a larger population sample. | PMC10802776 | |
REFERENCES | PMC10802776 | |||
Background | Coronary chronic total occlusion (CTO) interventions are more complex than general percutaneous coronary intervention (PCI) procedures. However, only a few nursing methods are specifically applied to patients undergoing CTO interventions. And the conventional nursing effect is not ideal, urgent need to explore more effective nursing methods. The checklist is a simple and effective tool for error management and performance improvement that has been widely used in many fields. But there have been no reports of the checklist being used to improve care for CTO patients. | PMC10688462 | ||
Objective | anxiety | ADVERSE EVENTS | This study aimed to investigate the effectiveness of a checklist-based nursing care process in patients undergoing Coronary chronic total occlusion (CTO) interventions, including duration of care, patient anxiety, improved patient satisfaction, and occurrence of adverse events. | PMC10688462 |
Methods | A total of 120 CTO patients undergoing percutaneous coronary intervention (PCI) were selected at our hospital and divided into an intervention group ( | PMC10688462 | ||
Results | ADVERSE EVENTS | The intervention grouphad significantly shorter preoperative nursing care time and significantly lower the total number of adverse events than the control group ( | PMC10688462 | |
Conclusion | anxiety, ’ | ADVERSE EVENTS | The application of the checklist-based nursing care process in patients with CTO intervention can significantly reduce the preoperative nursing care time, reduce patient anxiety, improve patients’ and doctors’ satisfaction with nursing care, and effectively reduce the occurrence of adverse events caused by nurses’ omissions or inadequate instructions. | PMC10688462 |
Trial registration | The protocol of the trial was registered retrospectively of Chinese Clinical Trial Registry (registration number ChiCTR2200056804, reg date17/02/2022). | PMC10688462 | ||
Keywords | PMC10688462 | |||
Background | Q-wave, non-occlusive disease, anxiety | ADVERSE EVENTS, CEREBROVASCULAR ACCIDENT, CORONARY ARTERY DISEASE | Coronary chronic total occlusion (CTO) is a common type of lesion in patients with coronary artery disease, and percutaneous coronary intervention (PCI) serves as one of the primary treatment methods for CTO patients [Traditionally, PCI for non-occlusive disease was considered a low-risk procedure for patients with stable coronary artery disease. A national audit of over 100,000 PCIs conducted annually reported early Q-wave MI, emergency CABG, cerebrovascular accident, and mortality rates at 0.03%, 0.02%, 0.04%, and 0.14%, respectively36. However, significant advancements in coronary intervention equipment now allow successful revascularization of a broad range of CTO lesions using advanced techniques. Performing CTO interventions safely requires specialized training and education in centers committed to achieving a high level of success for these challenging procedures [When performing interventions in hospitalized patients with CTO, various nursing-related challenges arise [Therefore, this study aims to evaluate the application of checklist-based nursing care for patients undergoing CTO interventions by analyzing various indicators, including the duration of care, patient anxiety levels, improved patient satisfaction, and occurrence of adverse events. | PMC10688462 |
Methods | PMC10688462 | |||
Study design | Our study began with the formulation of the checklist.The design of the checklist was based on the latest version of the 2020 Chinese Interventional Guidelines, CTO Guidelines, and related literature, combined with the current situation of the department where the work was conducted, to develop a list of nursing tasks before and after CTO interventions in line with clinical reality. The contents of the checklist were subjected to expert correspondence by the Delphi method [ | PMC10688462 | ||
Sample and setting | Patients who underwent CTO intervention in the Department of Cardiology, Shengjing Hospital, China Medical University, in Shenyang, China, from December 2020 to July 2021, were selected.The inclusion criteria were as follows: [The exclusion criteria were as follows: [ | PMC10688462 | ||
Interventions | Anxiety | ADVERSE EVENTS | Intervention group: The checklist-based nursing care process was used to provide care and education to patients with CTO before and after PCI, and the specific contents and methods are as follows. A paper version of the checklist-based nursing process required for the study was also printed. After the patient with CTO is admitted to the hospital, the primary nurse will create a checklist for him/her, fill in the complete patient information, and manage the admitted patient according to the checklist item by item, that is, tick “√” at “yes” for completed tasks and “√” at “no” for those that are not completed. If the patient fails to complete this item during the implementation process, tick “√” at “not applicable,” and the checklist will be kept for statistical purposes after the patient is discharged from the hospital. Within 24 h of admission, the primary nurse will score the patient based on the Self-Rating Anxiety Scale (SAS) and provide nursing care to the patient following the “Preoperative Nursing Care Checklist for Patients with CTO.”Nurses need to be trained on intervention prior to intervention.All contents of the preoperative nursing care checklist for patients with CTO should be completed 1 day before surgery to 1 h before surgery (Fig.
Preoperative-PCI nursing care checklist for CTO patients
Postoperative-PCI nursing care checklist for CTO patientsControl group: Nursing care process for patients with CTO was carried out according to existing working methods, clinical observation, and health education. That is, nurses performed preoperative preparation and provided postoperative nursing care according to medical advice and personal work habits after patients were admitted to the hospital, placed intravenous indwelling needles one day or on the same day before surgery, performed skin preparation in the operating area, and provided preoperative diet, medication, and psychological guidance. The time required to complete all preoperative nursing tasks was recorded. The patient’s clinical observation, wound care, postoperative education, diet instruction, medication, and psychological guidance were conducted regularly according to the doctor’s postoperative advice. The preoperative and postoperativeSASscoring was performed within 24 h of admission and before discharge, respectively. The doctor satisfaction survey was conducted after surgery. The patient satisfaction survey was performed before discharge, and the occurrence of adverse events was recorded.Quality control: [ | PMC10688462 |
Measurements | bleeding, anxiety, site injury, postoperative urinary difficulties, hematoma | ADVERSE EVENTS, BLEEDING, HEMATOMA | Preoperative nursing care time. This refers to the sum of time spent by the primary nurse on all matters related to preoperative preparation, which was timed by the primary nurse herself.The less total preoperative nursing care time, the less the work time.Occurrence of adverse events due to nurse’s omission or inadequate instruction. This includes inadequate preoperative patient preparation (failure to leave a venous access or incorrect placement of the venous access, blockage of the venous access, failure to prepare the skin in the operative area, and omission of preparations), failure to clean the contaminated operative area during surgery (such as vomitus and feces), and failure to train the patient about defecation on bed after surgery resulting in postoperative urinary difficulties, puncture site injury, bleeding, hematoma, and skin problems in patients after braking of the femoral artery puncture.Patients’ anxiety. The SAS scale was used to compare the preoperative and postoperative anxiety of the two groups. There were 20 items in total, and the 4-level scoring methodwas adopted, with 15 positive scores and 5 negative scores.<50 points indicate no anxiety, 50–59 points indicate mildanxiety, 60–69 points indicate moderate anxiety, and > 69points indicate severe anxiety [Doctor and patient satisfaction. The “Doctors’ Satisfaction with Nursing Care Questionnaire” and the “Patients’ Satisfaction with Nursing Care Questionnaire” were used for the assessment. The higher the score, the better the satisfaction. | PMC10688462 |
Validity and reliability of instruments | Cronbach’s α of SAS was 0.932.The content validity index of the nursing care checklist for CTO patients was 0.82, and internalconsensus reliability Cronbach’s α coefficient was 0.859. The content validity index of theDoctors’ Satisfaction with Nursing Care Questionnairewas 0.85, and internalconsensus reliability Cronbach’s α coefficient was 0.893. Thecontent validity index of Patients’ Satisfaction with Nursing Care Questionnairewas 0.83, and internal consensus reliability Cronbach’s α coefficient was 0.898. All the above scales have good reliability and validity. | PMC10688462 | ||
Randomization | BLIND | Doctors use random sequence software to generate 1 to 120 random serial numbers. Random serial numbers and then in the order in which the patients were treated, from front to back. Odd-numbered patients were included in the intervention group, while even-numbered patients were included in the control group. In order to avoid cross-infection during the experiment, the intervention group and the control group were arranged in wards A and B respectively. (Note: Both groups of patients were blinded, meaning they were unaware of whether they were in the experimental group or the control group; Doctors who evaluate the quality of patient care use a blind method, that is, they are unaware whether the evaluated patients are in the experimental group or the control group; The nurses in the control group used a blind method, that is, they were unaware that the ward had become the control group and still used existing working methods to care for patients; The nurses in the experimental group used a non blind method, that is, they were aware of using checklists to care for patients and received unified training.) | PMC10688462 | |
Sample size | Group sample sizes of 43 and 43 achieve 90% power to reject the null hypothesis of equal means when the population mean difference of preoperative nursing care time is 5 min and - with a standard deviation for both groups of 7 min and with a significance level (alpha) of 0.050. Assuming a 20% potential dropout rate, the final sample size was increased to 120 subjects, with 60 subjects in each intervention group. | PMC10688462 | ||
Statistical analysis | SPSS 26.0 software was used for statistical analysis. Measurement data were expressed as (‾x ± s), and the t test was used for comparison between groups. Count data were expressed as number of cases or percentage, and the χ2 test was used for comparison between groups. The difference was considered significant at | PMC10688462 | ||
Result | PMC10688462 | |||
The basic information between the two groups | Among the 120 patients, 109 completed the study, and 11 patients did not complete the questionnaire due to early discharge from the hospital. The final intervention group included 56 patients with mean age of (65.05 ± 10.14) years, and the control group included 53 patients with mean age of (65.02 ± 10.73) years. No significant difference was found between the two groups in terms of age, gender, ethnicity, marital status, job and health insurance type, and days of hospitalization (all P > 0.05; Table | PMC10688462 | ||
Preoperative nursing care time | The average preoperative nursing care time in the intervention group was 37.61 ± 5.15 min, which was much lower than the 50.98 ± 5.61 min in the control group. In the intervention group, 71.4% and 28.6% of the patients had preoperative nursing time < 40 and 40–50 min, respectively, and all patients had preoperative nursing time < 50 min, compared with 3.8% and 37.7%, respectively, in the control group. In addition, 58.5% of patients had a preoperative care time > 50 min. The preoperative care time in the intervention group was significantly reduced compared with that in the control group, and the difference was significant ( | PMC10688462 | ||
Occurrence of adverse events | dysuria, bleeding, hematomas, vomiting | PRESSURE SORE, BLEEDING, HEMATOMAS, ADVERSE EVENTS, ADVERSE EVENT | Preoperatively, the intervention group had indwelling venous access in the wrong limb and one venous access blockage, while the control group had two non-indwelling venous accesses, two indwelling venous accesses in the wrong limbs, and three blocked venous accesses. Intraoperatively, vomiting and defecation did not occur in theintervention group, while one case of vomiting and two defecations were recorded in the control group. During the postoperative period, one case of bleeding at the puncture site without dysuria and skin-related problems occurred in the intervention group, while in the control group, one case of bleeding at the puncture site, two hematomas at the puncture site, two cases of dysuria, and one case of degree I pressure sore caused by braking after femoral artery puncture occurred. When each adverse event was compared separately,there was no significant difference (P > 0.05) except the “Omission goods”. However, the total number of adverse events, the occurrence of nursing-related adverse events in the intervention groupwas significantly lower than that in the control group ( | PMC10688462 |
Patient anxiety | anxiety | Most patients in both groups had different levels of anxiety before surgery, and the difference in SAS scores was not significant (P > 0.05).There was no significant difference in the number of people with no anxiety, mild anxiety, moderate anxiety and severe anxiety (P > 0.05). The postoperative SAS scores decreased in both the observation and control groups compared with the preoperative scores, but the preoperative SAS score decreased from 65.58 ± 8.20 to 53.03 ± 10.24 in the intervention group, while the preoperative SAS score decreased from 66.27 ± 9.73 to 60.87 ± 8.97 in the control group.The postoperative SAS score of the intervention group was significantly lower than that of the control group ( | PMC10688462 | |
Doctor and patient satisfaction | ADVERSE EVENTS | The doctor and patient satisfaction scores of the intervention group were higher than those of the control group. The implementation of the checklist-based nursing care was effective in enhancing doctor and patient satisfaction with nursing care, and a significant difference was found between the two groups (
The basic information between the two groups
Comparison of preoperative care time between two groups of patients
Comparison of the incidence of nursing-related adverse events in the two groups [n(%)]
Comparison of SAS scores in the two groups
Comparison of doctor and patient satisfaction in the two groups (‾x ± s, scores) | PMC10688462 | |
Discussion | Anxiety, anxiety, depression, acute coronary syndrome, defecation difficulties, intraoperative vomiting or defecation | ADVERSE EVENTS, ADVERSE EVENT, PRESSURE SORE, ACUTE CORONARY SYNDROME | At present, there is no unified standard and consensus on the nursing care process before and after PCI procedures in China, and various medical units have discussed the nursing care methods for patients undergoing PCI procedures from different nursing perspectives [This study showed that the nurses in the intervention group spent significantly less time on preoperative nursing care than those in the control group.The nurses in the intervention groupused a preoperative nursing care checklist and completed the checklist item by item to ensure the continuity of nursing care. Despite interruptions in some special cases, the overall time spent on preoperative nursing care was significantly reduced; thus, nurses could be more consistent in providing care and could devote the time saved to other nursing tasks.Adverse events related to nursing care in patients with CTO before and after surgery were mainly caused by poor instructions and work omissions by nurses. In this study, both groups of patients had a high incidence of preoperative adverse events, which could indirectly lead to corresponding intraoperative and postoperative adverse events. The rates of various adverse events in the intervention groupbefore, during, and after surgery were significantly lower than those in the control group, and none of the patients in theintervention group experienced intraoperative vomiting or defecation, nor did they have any skin problems related to defecation difficulties or pressure sores after surgery, indicating that the adoption of the checklist-based nursing care process resulted in more adequate preoperative preparation and ensured that the nurses did not miss patient care tasks. Moreover, the adoption of the checklist-based nursing care process helped reduce the incidence of nursing-related adverse events in CTO surgery.Anxiety is common in patients undergoing PCI, and several factors can increase the risk of depression in patients [This study also showed that the patients in both groups had different anxiety levels before surgery and that their anxiety scores decreased after surgery. However, compared with the scores of the control group, the scores of the intervention group decreased more significantly. This finding indicates that after the application of the checklist-based nursing care process, the nurses provided holistic preoperative and postoperative nursing care to patients, the nursing care was more consistent, the preoperative preparation was adequate without omission, the education content was complete, and the postoperative health education and psychological nursing care for patients played a certain role in alleviating anxiety.Relevant reports proposed that the whole seamless link nursing intervention can shorten the time of regional collaborative treatment for patients of acute coronary syndrome, improve the prognosis, reduce the economic burden of patients, and improve the efficiency of acute coronary syndrome treatment [Clinicians are the closest and most important partners of nurses, and the evaluation of nursing work by doctors has a strong reference, which is of great significance to improve nursing services, enhance nursing quality, and promote hospital development [ | PMC10688462 |
Clinical implementation | confusion | ADVERSE EVENTS | The nursing checklist used in this study can be applied to the perioperative care of clinical CTO patients undergoing PCI. Nurses refer to the checklist to implement nursing measures for patients one by one, and mark the completed items before completion to avoid omissions and confusion. Its content is clear and concise, classified according to items and content, easy to operate, standardized and easy to implement, and standardized the nursing process of CTO patients, And it is concluded that using checklists to care for CTO patients can improve work efficiency and reduce the occurrence of adverse events. | PMC10688462 |
Research recommendation and future considerations | This study is the first time that Checklist-based Nursing has been applied to the care of patients undergoing CTO interventional operation. Therefore, more randomized controlled trials should be conducted using other feasible nursing methods to identify the best and most effective nursing methods for CTO interventional operation. | PMC10688462 | ||
Research strengths and limitations | coronary artery disease | VASCULAR DISEASE, CORONARY ARTERY DISEASE, COMPLICATIONS | In Chinese studies, studies on improving nurses’ work efficiency before and after PCI are rarely found in the literature, and there are even fewer nursing processes solely for CTO patients. Starting from the nurses themselves, this study is the first to apply the checklist to patient nursing for CTO interventional procedures to explore effective working methods that can reduce the nursing staff’s preoperative preparation time and reduce nursing errors. The main limitation of this study is that it was a single-center experiment, which reduces generalizability. The selected patients were patients with standard conditions of CTO interventional operation, and the excluded patients were not collected. It is stated that the clinical nurses using the checklist recorded the amount of time they spent on preoperative preparation of patients. There is therefore the potential for bias to be introduced, as the nurses were evaluating their own practice. Due to limitations in the research design, this study did not employ a fully random method, which may introduce certain selection bias.CTO is a complex vascular disease, and studies have shown that nursing intervention in the interventional treatment of chronic completely occluded coronary artery disease can not only improve the success rate of surgery, but also reduce complications, making patients satisfied, which is consistent with the nursing intervention results used in this study. A systematic review [ | PMC10688462 |
Acknowledgements | Not applicable. | PMC10688462 | ||
Authors’ contributions | Made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data: Xia Ge, Zhe Zang, Haiyang Wu. Involved in drafting the manuscript or revising it critically for important intellectual content: Xia Ge, Jiayi Xie. All authors read and approved the final manuscript. | PMC10688462 | ||
Funding | This research was funded by a grant from Shengjing Hospital of China Medical University. | PMC10688462 | ||
Data Availability | The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10688462 | ||
Declarations | PMC10688462 | |||
Ethics approval and consent to participate | The purpose of this study is to establish a perfect nursing process, so that nurses can improve nursing efficiency in their work, without causing any loss to patients and without relevant invasive operations. This study followed the Declaration of Helsinki [ | PMC10688462 | ||
Consent for publication | Not applicable. | PMC10688462 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10688462 | ||
References | PMC10688462 | |||
Background | AUD | DISORDER, SECONDARY, LITTLE | Alcohol Use Disorder (AUD) is one of the most stigmatized diagnosis, and stigma imposes a major barrier to treatment seeking. There is a need to develop interventions that can reduce stigma and increase treatment seeking. Little is known about the effects of video materials. The aim of this study was to investigate effects of different videos. The primary outcome was public stigma, and secondary outcomes were: self-stigma, and motivation to change own alcohol use; talking to someone else about their alcohol use; seeking information about AUD treatment or seeking AUD treatment. | PMC10552234 |
Methods | REGRESSION, BLIND | This is a three-armed double blind randomized controlled study. The study included 655 Danish adults. Data was collected at a study webpage, and the survey could be completed anywhere with Internet access. After informed consent and completing baseline measures, participants were randomized, 1:1:1 ratio, to a video (video 1 n = 228; video 2 n = 198; video 3 n = 229). Video 1 and 2 have been used in a national mass media campaign and video 3 was recorded for use in the present study. Immediately after exposure, follow-up measures were completed. Outcomes were analyzed with mixed effects linear regression. | PMC10552234 | |
Results | In total n = 616 completed follow-up (video 1 n = 215; video 2 n = 192; video 3 n = 209). Randomization to video 1 and 3 decreased public stigma measured with “Difference, Disdain & Blame Scales”, while video 2 increased stigma. Video 2 compared to 1: 2.262 (95% CI 1.155; 3.369) | PMC10552234 | ||
Conclusions | ADVERSE EFFECTS | Videos can have an immediate effect on level of public stigma. Other types of interventions are needed to increase motivation and reduce self-stigma. To avoid adverse effects in future interventions, the use of theoretical frameworks and stakeholder involvement is emphasized. | PMC10552234 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-16811-4. | PMC10552234 | ||
Keywords | Open access funding provided by Karolinska Institute. | PMC10552234 | ||
Background | psychiatric disorder, AUD, SUD | DISORDER | Alcohol use disorder (AUD) is the most prevalent substance use disorder (SUD), directly affecting 100.4 million individuals worldwide [Even though AUD is common, it is among the most highly stigmatized psychiatric disorder in the Western world [Stigma has a range of negative consequences for individuals with AUD. On a structural level, it can lead to discriminating policies and low financial allocations [ | PMC10552234 |
The role of mass media campaigns | In Denmark, 98% of the population use the Internet, and 84% are active on social media [Interventions based on education and on increasing social contact between groups have been shown to be effective in reducing public stigma [Mass media campaigns have the potential both to reduce stigma and also increase treatment seeking for AUD. However, there is a dearth of knowledge on this topic. | PMC10552234 | ||
The RESPEKT campaign | RESPEKT | SECONDARY | The Danish NGO-organization “Alkohol & Samfund” [English: “Alcohol & Community”] and the private Foundation “Trygfonden” [aimed at supporting research and prevention-initiatives], in cooperation with media / PR agencies and local alcohol treatment services, have developed a media campaign, “RESPEKT,” which has been broadcast annually across Denmark since 2015. The aims of the campaign were to:
Increase public awareness that the council offers AUD treatment free of charge.Increase the number of individuals who seek advice, or seek / initiate treatment for AUD.The campaign is a targeted communication approach [The campaign is multi-component, where the main channels are TV and Internet advertisements. The content of the main campaign video has varied over the years. From 2016 to 2018 and year 2020 the video showed three boys in a football locker room, where one boy proudly tells his friends that his father has stopped drinking. The video ends with father and son hugging, and the message “it gives respect to do something about your alcohol problem.” In 2019, the video showed a child at home, cleaning up beer cans while the father is asleep on the living room sofa. The boy makes sandwiches for the father and writes the number of the national telephone help line for AUD on a post-it note to his father, before leaving home.The RESPEKT campaign is unique from an international perspective, with its aim to increase treatment-seeking. In a previously published cross-sectional study, we have studied how the message of the campaign was understood and how it impacted awareness, attitudes, and information seeking [The aim of this study is to investigate effects of viewing either one of the two videos used in the RESPEKT campaign or a neutral video, informing that AUD treatment is free, on the primary outcome measure:
public stigma.The secondary outcome measures:
motivation to change one’s own alcohol use.motivation to talk to someone else about their alcohol use.motivation to seek information about AUD treatment.motivation to seek AUD treatment.self-stigma.The hypothesis is that randomization to video 1 with the boy and father at the football ground leads to lower level of public stigma and self-stigma, and also higher motivation to change one’s own alcohol use, to talk to someone else about their alcohol use, to seek information about treatment and seek treatment; compared to randomization to video 2 with the boy and father at home or viewing video 3, with information about AUD treatment. The rationale is that video 1 includes messages that can have a stigma reducing effect, as recovery, and messages that can increase motivation, via the focus on positive consequences of making a behavior change, as being a better parent [ | PMC10552234 |
Methods | PMC10552234 | |||
Study-design | BLIND | This is a three-armed double blind randomized controlled study. | PMC10552234 | |
Participants | The participants, adults 18 years and older, were recruited via convenience sampling. | PMC10552234 | ||
Procedure | A study webpage was launched in year 2020, after the RESPEKT mass media campaign period was completed [
The RESPEKT video featuring the boy and father at the football ground [The RESPEKT video featuring the boy and father at home [A video beginning: “Are you worried that you drink too much? Have others told you that, or are you concerned about your health?”, followed by information that AUD treatment is free of charge and that it is possible to seek anonymously [Immediately after exposure the participants were asked to complete outcome measures. | PMC10552234 | ||
Data collection | DISORDER, ABUSE | Data was collected at the study webpage, and submitted to the REDCap database hosted by OPEN [The baseline measures included:
Demographic data on gender, age, education, marital status, children, country of birth and occupational status.Alcohol use, assessed with Alcohol Use Disorder Identification Test – consumption (AUDIT C), including three items on level of alcohol use which were scored 0–4, giving a total score ranging from 0 to 12 [Previous experience of seeking treatment for AUD.Knowing someone with experience of AUD.Public stigma assessed with Difference, Disdain & Blame Scales for Public Stigma [Motivation to change one’s own alcohol use, motivation to talk to someone else about their alcohol use, motivation to seek information about AUD treatment and motivation to seek AUD treatment were assessed with a visual analogue scale (VAS), ranging from one (Not at all) to nine (To a very high degree) [Participants who endorsed ongoing or previous concern for their alcohol use were presented a questionnaire measuring self-stigma, the Self-Devaluation Subscale, of the Substance Abuse Stigma Scale [Immediately after exposure, awareness of seeing the video previously was assessed and then measures of public stigma, self-stigma and motivation were repeated.Which video, participants were randomized to, was blinded to the researchers and only a number (video 1, 2 or 3) was presented.There was no a priory power calculation. | PMC10552234 | |
Data analyses | MP | REGRESSION | Characteristics of participants at baseline were reported for the overall sample and separately for the three exposure groups. Counts and proportions were reported for categorical characteristics.The numerical data on public stigma, motivation to change one’s own alcohol use, motivation to talk to someone else about their alcohol use, motivation to seek information about AUD treatment, motivation to seek AUD treatment and self-stigma were analyzed by mixed effects linear regression. The models included a fixed effect for group randomized to, a fixed effect for time point (baseline and follow-up) and a fixed effects interaction between group and time point. As baseline measurements were obtained before randomization, groups at baseline were modelled as a separate common treatment category, constraining baseline measurements to no systematic treatment effect between the groups. All mixed models included a random intercept for each participant. Normality assumptions were evaluated visually, and deviations were handled by repeating the analysis with nonparametric bootstrapping. Using the maximum likelihood estimator and assuming the dropout mechanism is ‘missing at random’, linear mixed models deal efficiently with missing values. Estimates were calculated with 95% confidence intervals (CI). Cohen’s As the results on motivation to change own alcohol use showed the opposite result from a priori hypothesis, post hoc analyses were performed to understand the findings more fully. First, the sample was stratified into two, according to level of motivation at baseline, where the participants who scored in 75th percentile or higher were grouped into the high motivation-group and compared to the participants who scored in the 74th percentile and lower. Second, the sample was stratified according to level of alcohol use according to the AUDIT-C – one group with participants with low-risk alcohol use, and one group with participants with hazardous alcohol use.All analyses were carried out using Stata MP 16.1 (StataCorp LP, College Station, TX). The blinding of which video the participants saw, was not broken until the analyses were completed. | PMC10552234 |
Results | Of 848 participants who entered the study, 72% (n = 655), completed the baseline measures and were randomized (Fig.
Consort flow diagramThe majority of participants were female (75%) and the mean age was 43 (SD 14). A majority, 68%, had an employment, while circa 20% were students (Table
Demographic of participants who completed the follow up measures1) Alcohol use, assessed with AUDIT C, total score ranging from 0 to 12. Total scores of three or above for women and four and above for men indicate hazardous alcohol useThe time for completing the survey did not differ between groups chi2 [
Survey duration and proportion of the participants who endorsed seeing the campaign film before the studyAwareness varied between which video the participants were randomized to. Almost three out of four endorsed having seen video 1 before this study, one in five endorsed having seen video 2, while only 2% endorsed having seen video 3 before, chi2 [The mean score on public stigma was 33.28 (SD 10.22, median 32) at baseline (Table
Mean, SD and median of each variable, at pre and post measure, presented according to randomization groupAmong participants randomized to video 1 and 3, a decrease in public stigma was seen from baseline to follow-up (Fig.
Estimates of change from pre to post measure presented according to randomization with 95% CIIn all three conditions, a decrease in motivation to change own alcohol use was seen from pre to post measure. There was a larger decrease in motivation among participants randomized to video 2 compared to video 1. Cohen’s Among participants randomized to video 2, a decrease in motivation to seek information about treatment for AUD was seen from baseline to follow-up, with Cohen’s No change in motivation to talk to someone else, motivation to seek treatment for AUD or self-stigma was found. | PMC10552234 | ||
Post hoc analyses | PMC10552234 | |||
Motivation to change own alcohol use – grouped according to level of motivation | All groups, but participants with low motivation at baseline randomized to group 1, decreased their motivation to change one’s alcohol use from pre to post measure (Table
Post hoc analyses of within and between group differences in motivation to change one’s own alcohol use. Participants grouped according to level of motivation (low or high)Low motivation(n = 467)High motivation(n = 176)Group 2 − 1Between groupsGroup 3 − 1Between groupsGroup 3 − 2Between groupLow motivation(n = 467)High motivation(n = 176)Randomization to video 2 decreased motivation to change alcohol use to a larger extent compared to randomization to video 1. The same findings were made both among participants with low and high motivation at baseline. No other group differences were found. | PMC10552234 | ||
1.3.2. Post hoc analyses | PMC10552234 | |||
Motivation to change own alcohol use – grouped according to level of alcohol use | There was a decrease in motivation to change one’s alcohol use in all groups, except among participants with low-risk alcohol use randomized to video 1 (Table
Post hoc analyses of within and between group differences in motivation to change one’s own alcohol use. Participants grouped according to level of alcohol use (low-risk or hazardous alcohol use)Low risk alcohol use(n = 333)Hazardous alcohol use(n = 322)Group 2 − 1Between groupsGroup 3 − 1Between groupsGroup 3 − 2Between groupLow risk alcohol use(n = 333)Hazardous alcohol use(n = 322)Among participants with hazardous alcohol use, those randomized to group 2 reported lower motivation to change compared to those randomized to group 1. Participants with hazardous alcohol use randomized to group 3 reported lower motivation compared to those randomized to group (1) No differences were found between participants with hazardous alcohol use randomized to group 3 and group (2) No differences between groups were found among participants with low-risk alcohol use. | PMC10552234 | ||
Discussion | PMC10552234 | |||
Level of public stigma | The a priori hypothesis, that Video 1 is set in a context common for many in the general Danish population - children and parents at football. This can potentially question the stereotype that individuals with AUD are different from others [Video 2 depicted a father with probably severe AUD, asleep on a sofa. While the message of the video is that significant others to problem drinkers should be helped, the video also includes several messages that can strengthen the stereotype of differentness – not being in recovery [Video 3 included information about AUD treatment and included concerns about alcohol use commonly reported in the general population [ | PMC10552234 | ||
Motivation to change one’s own alcohol use | Overall, the Available evidence on both mass media campaigns aiming to reduce alcohol and tobacco harm, show that campaign messages including reasons to make a change, so called “why-messages”, and messages that address long-term harms of alcohol, are more effective in strengthening motivation to change, compared to campaign messages focusing on Video 1, which did not decrease motivation to the same extent as the other two videos, included aspects of “why-messages”, as being a present parent and gaining respect from others. However, these social consequences do not seem as effective in eliciting motivation as messages on long-term and internal physical harm of alcohol use, which apply broader to all viewers [Future studies should also consider the emotional tone of videos. The alcohol harm literature suggests including a negative emotional tone, compared to a positive, elicit higher motivation to change [ | PMC10552234 | ||
Motivation to seek treatment for AUD | Participants randomized to video 2, decreased their A recent cross-sectional survey showed a positive association between engaging in social media posts of others change of alcohol use or treatment seeking for AUD, and own self-reported treatment seeking [ | PMC10552234 | ||
Motivation to talk to someone else about their alcohol use | SECONDARY | The social network around individuals with AUD was a secondary target group of the RESPEKT campaign. Social support is an important factor for seeking AUD treatment [ | PMC10552234 | |
Self-stigma | Nor were any effects on | PMC10552234 | ||
Strengths and limitations | The use of self-report measures, can pose an increased risk of socially desirable answers. A stigma questionnaire measuring differentness was used, which is considered to impose less risk of bias [Moreover, the study focused on immediate effects of randomization to different videos. This exposure may not be transferable to a real-world context, where exposure to campaign videos can occur repeatedly. Future studies should include a longer follow up, especially for interventions aiming to reduce stigma [The level of public stigma associated with AUD reported in this study, was lower compared to a recent study which included participants from the general Danish population [An important strength of the study is the double-blinded design, where the participants were blinded for the randomization and the researchers for the allocation, which ensures validity by minimizing observer bias and researcher bias. Also, that the study is conducted by independent researchers, not involved in the development of the campaign, which can contribute with new perspectives and insights. | PMC10552234 | ||
Conclusions | Video materials focusing on recovery and reducing the perception of differentness have an immediate effect on decreasing public stigma associated with AUD. The unexpected detrimental effects highlight the need for careful considerations, use of theoretical frameworks and stakeholder involvement in the development of video materials. There is a need to develop other types of messages or interventions to increase motivation to seek treatment for AUD, motivation to talk to someone else and reduce self-stigma. We suggest future studies focus on messages aimed to the general population rather than targeted communication. | PMC10552234 | ||
Acknowledgements | Not applicable. | PMC10552234 | ||
Author contributions | SWF conceptualization, methodology, data curation, statistical analysis, writing original draft preparation. AM methodology, statistical analysis, writing reviewing, editing. RB methodology, writing reviewing, editing. ANS conceptualization, methodology, writing reviewing, editing. | PMC10552234 | ||
Funding | TrygFonden, grant number 129450. The funding source had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.Open access funding provided by Karolinska Institute. | PMC10552234 | ||
Data Availability | The data underlying this article cannot be shared publicly due to the privacy of individuals that participated in the study. The data will be shared on reasonable request to the corresponding author. | PMC10552234 | ||
Declarations | PMC10552234 | |||
Ethics approval and consent to participate | The study was approved by the Research Ethics Committee at the University of Southern Denmark on the 14th of January 2021, registration number: 20/70424. All participants gave their informed consent to participate. The study was performed in accordance with the Declaration of Helsinki. | PMC10552234 | ||
Consent for publication | Not applicable. | PMC10552234 | ||
Competing interests | We have no conflict of interest to report. | PMC10552234 | ||
List of abbreviations | Alcohol Use DisorderAlcohol Use Disorder Identification Test ConsumptionCompletely Automated Public Turing test to tell Computers and Humans ApartConfidence IntervalsCommunity Reinforcement and Family TrainingSubstance Use DisordersVisual Analogue Scale | PMC10552234 | ||
References | PMC10552234 | |||
Subject terms | TYPE 2 DIABETES | Transcutaneous electrical nerve stimulator (TENS) has been demonstrated to be beneficial in glycemic control in animal models, but its application in humans has not been well studied. We randomly assigned 160 patients with type 2 diabetes on oral antidiabetic drugs 1:1 to the TENS study device (n = 81) and placebo (n = 79). 147 (92%) randomized participants (mean [SD] age 59 [10] years, 92 men [58%], mean [SD] baseline HbA | PMC9932095 | |
Introduction | diabetic chronic complications, type 2 diabetes, postprandial hyperglycemia | TYPE 2 DIABETES | Despite numerous treatment options available, many patients with type 2 diabetes fail to achieve glycemic targets, leading to a significantly increased risk for diabetic chronic complications and related morbidity/mortalityTranscutaneous electrical nerve stimulator (TENS) is an approach that applies electrical impulses generated by specifically designed devices, and delivered through electrodes placed on the skinHowever, current data in humans are scarce. The effect of TENS has been proved by a new exercise method for treating postprandial hyperglycemia in 11 patients with type 2 diabetes | PMC9932095 |
Results | PMC9932095 | |||
Secondary outcome | The proportion of subjects achieving HbAFPG at each visit for ITT and PP populations are shown in Supplementary Table According to subgroup analysis (Supplementary Table | PMC9932095 | ||
Other outcomes | tumor necrosis | TUMOR NECROSIS | The 7-point SMBG was measured immediately before breakfast, lunch, and dinner, two hours after each meal, and at bedtime, at week 0, 4, 12 and 20. In the TENS group, the 7-point SMBG maintained relatively more stable GV compared to the placebo group, as reflected by the significant difference of MAGE at week 20 between the TENS group and the placebo (66 (33) mg/dL [95% CI 58, 73] vs. 79 (33) mg/dL [95% CI 72, 87]) (Table (Following 20 weeks of treatment, most subjects in the TENS and the placebo groups maintained stable OAD regimens in the maintenance period of the study. Overall, four subjects had OAD regimen change: two in the TENS group, and two in the placebo group (Supplementary Table Exploratory biomarkers including CRP, adiponectin, TNF-α, and FGF-21 were performed at week 0 and 20. Figure Change of exploratory parameters from before (week 0) and after (week 20) treatment in Transcutaneous Electrical Nerve Stimulator (TENS) vs. the placebo group. Statistical analysis with mixed model two–way ANOVA was carried out. Values are means ± standard error of mean (SEM), ns, non-significant. CRP, C-reactive protein; TNF-α, tumor necrosis factor-α; FGF-21, fibroblast growth factor-21. | PMC9932095 |
Discussion | hyperglycemia, hypoglycemic, Hypoglycemia, diabetes | HYPERGLYCEMIA, DIABETES, BLIND, EVENTS, TYPE 2 DIABETES, HYPOGLYCEMIA | This was a phase 3, prospective, double blind, randomized, placebo-controlled, multi-center, pivotal study to investigate the efficacy and safety of TENS in improvement of glycemic control in patients with type 2 diabetes. The primary efficacy endpoint is to compare the HbAHowever, according to the subgroup analysis, we found that female patients in the TENS group but not the placebo group exhibited a significant HbAWe further found that the 7-point SMBG maintained a relatively more stable GV in the TENS group compared to the placebo group, as reflected by MAGE reduction, with a greater decline found throughout the study in the TENS group compared to the placebo group. From week 0 to week 20, MAGE decreased 19 mg/dL in the TENS group and 9 mg/dL in the placebo group and became significantly different at week 20 (Fig. The significant effect of TENS on MAGE reduction is a post-hoc novel finding of our study. MAGE has long been recognized as an indicator of GV and thus represented as an important part of diabetes control because of the need to reach target HbARegarding the safety aspect of the study device, over 80% of TEAEs were mild, and no serious adverse device effects were reported. Hypoglycemia was the most common AE presented with six events occurring in five subjects receiving TENS and 14 events occurring in nine subjects receiving placebo, while hyperglycemia requiring rescue medication was encountered in one subject in the TENS group vs. three subjects in placebo group. Overall, patients in the TENS group experienced less hypoglycemic and hyperglycemic events when compared to placebo, which corroborates with the previous finding that TENS is associated with significant reduction in GV. We propose the underlying mechanism might involve the harmonious regulation of glucagon and insulin secretions associated with TENS, leading to maintenance of optimal glucose homeostasisThroughout the study, we also found significant decline of CRP from baseline in the TENS group, but not in the placebo group. In addition, CRP and FGF-21 showed significant group effects in the TENS group vs. the placebo group. Although the other biomarkers examined in this study did not show significant change, the decreases in CRP and FGF-21 in the TENS group demonstrated potential improvement in systemic inflammationThe limitations of this study are listed as below. First, the duration of the study was only 20 weeks, and it is not known whether the MAGE reduction would be sustained or even better for a longer duration as revealed in this study in a time-dependent manner. An extension of the study period to 40 weeks might help to answer the question. Second, since continuous glucose monitoring (CGM)-derived MAGE has been shown to be more accurate than that derived from self-monitoring of blood glucoseIn conclusion, the domestic use of both “Dragon Waves Resonant Home Care” Transcutaneous Electronic Nerve Stimulator (TENS) and placebo (sham TENS ineffective pulse wave) demonstrated a modest effect in glycemic control and were well tolerated without safety concerns in patients with type 2 diabetes. Nonetheless, for the primary endpoint, TENS did not demonstrate a statistically difference in the HbA | PMC9932095 |
Methods | PMC9932095 | |||
Study design and participants | type 2 diabetes | TYPE 2 DIABETES, BLIND | This was a multi-center, prospective, double blind, randomized, placebo-controlled trial of transcutaneous electrical nerve stimulator (TENS) to improve glycemic control in patients with type 2 diabetes (ClinicalTrials.gov Identifier: NCT03102424). The study and all experimental protocols were approved by Institutional Review Boards of the six joining hospitals (National Taiwan University Hospital, National Cheng Kung University Hospital, Taipei Medical University, Chi Mei Medical Center, Far Eastern Memorial Hospital, and Ditmanson Chia-Yi Christian Hospital), and written informed consent was obtained from each study participant. All experiments were carried out in accordance with relevant guidelines and regulations.Subjects with type 2 diabetes who met all the inclusion but none of the exclusion criteria were randomized with a 1:1 allocation into either of the 2 groups below: 1. TENS, 2. placebo (sham TENS delivering ineffective pulse wave). The inclusion criteria, exclusion criteria and sample size determination are detailed in the Methods Section in Supplementary Material. A schematic diagram of study design is depicted in Supplementary Fig. | PMC9932095 |
Study intervention | traumatic scars | DIABETES MELLITUS | Study visits occurred every 2 or 4 weeks depending on the study phase. The study device “Dragon Waves Resonant Home Care” Transcutaneous Electronic Nerve Stimulator (Taiwan Resonant Waves Research Corporation, Taipei, Taiwan) is a small portable, battery-operated device equipped with wires and 2 patches, and the impulses are sent through wires to patches which are placed on bilateral abdominal wall. The study device used full-frequency wave resonant technology with mixed frequencies ranging from 1 to 20,000 Hz in the TENS group, and from 1 to 30 Hz in the placebo group, respectively. Both the mixed frequency sets were predefined and composed of monophasic square pulse wave with 50% duty cycle. The amplitude of the pulse wave was 7.2 Vpp in average. Patients with surgical or traumatic scars in the abdominal wall were excluded from the study to avoid any interference in the electrical conduction path. The specific location of the stimulation electrode is based on human anatomy to identify the stimulation points (for further details please refer to In pre-clinical setting, DW1330 has been tested in a mouse model of diabetes mellitus. The study is reported in accordance with ARRIVE guidelines ( | PMC9932095 |
Outcome assessments | tumor necrosis, TNF-α | TUMOR NECROSIS | Primary efficacy variable was the change in HbAWe also measured the changes in biomarkers C-reactive protein (CRP), adiponectin, tumor necrosis factorα (TNF-α), fibroblast growth factor-21 (FGF-21), as the exploratory assessments. CRP was determined by latex enhanced immunoturbidimetric assay (ADVIA 1800, ADVIA Chemistry XPT, Dimension EXL, SIEMENS). Adiponectin and TNF-α were measured by enzyme-linked immunosorbent assay (R&D Systems). FGF-21 was quantified by using enzyme-linked immunosorbent assay kits according to manufacturer’s instructions (Duoset human FGF21 ELISA kit, R&D systems, Inc., Minneapolis, MN, USA). | PMC9932095 |
Measurements and definitions | There were three analysis populations: intention-to-treat (ITT) population, per-protocol (PP) population, and safety population. Both ITT and PP populations were applied to efficacy analyses, while safety population was used in the analysis of safety variables. Definition of the three populations is detailed in the Methods section in Supplementary Material. | PMC9932095 | ||
Statistical analysis | The statistical analysis and data management including double data entry, data verification, data validation was performed periodically after receiving case report forms from sites. The statistical analyses were conducted using SAS | PMC9932095 | ||
Supplementary Information | The online version contains supplementary material available at 10.1038/s41598-023-29791-7. | PMC9932095 | ||
Acknowledgements | We thank Professors June-Tai Wu, Pei-Lung Chen, Chi-Tai Fang, and Dr. Yu-Ling Huang for their critical review and valuable discussion about this manuscript. We sincerely thank the clinical trial participants for their precious contribution of time and effort to the study. | PMC9932095 | ||
Author contributions | J.Y.L., H.Y.O., and L.M.C. developed the concept for this article. C.Z.W., C.Y.Y., J.Y.J., C.H.L., Y.D.J., T.J.C., Y.C.C., W.C.W., H.Y.L., Y.F.D., C.H.L., H.C.H., K.J.T., N.C.Y., S.Y.L., N.C.Y., S.Y.L., H.I.Y. enrolled their patients into this study. M.L.H. performed the FGF-21 assay. J.Y.L., H.Y.O., and L.M.C. analyzed the data and wrote the manuscript. All authors were responsible for reviewing and revising this article and assume responsibility and accountability for the results. | PMC9932095 | ||
Funding | LIVER DISEASE | This clinical trial was funded by the Liver Disease Prevention and Treatment Research Foundation, the Taiwan Resonant Waves Research Corporation and a grant (106-EC-17-A-22-I5-0-005) from the Ministry of Economics, Taiwan. The study machines and glucose meters used in this trial were provided by the Taiwan Resonant Waves Research Corporation. | PMC9932095 | |
Data availability | The data that support the findings of this study are available from Bestat Pharmaservices Corporation, but restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. Data are however available from the corresponding author upon reasonable request and with permission of Bestat Pharmaservices Corporation. | PMC9932095 | ||
Competing interests | The authors declare no competing interests. | PMC9932095 |
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