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PATIENTS AND METHODS | In this study, single‐blind participants are blinded to the parallel group that was initiated within a single institution. The study was approved by the Saga University Hospital Research Ethics Committee (Protocol number 2019‐07‐01), and informed consent was obtained from all subjects and/or legally acceptable representative (LAR) of subjects to participate in the study. This trial was registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (Registration number UMIN000046091). This study followed the 2010 Consolidated Standards for Reporting Trials (CONSORT) statement. The study was performed in line with the principles of the declaration of Helsinki. Regarding setting sample size, there were few similar research reports in the past. This study was conducted under the actual conditions of daily clinical practice, and the sample size was set as the number of possible cases within the study period. | PMC10728525 | ||
Participants and study design | undernutrition, mandibular fracture | UNDERNUTRITION | The study subjects were patients in the Department of Dental and Oral Surgery of Saga University Hospital (Saga, Japan) who required maxillomandibular fixation either after orthognathic surgery or for the treatment of mandibular fracture between October 2019 and December 2022. The subjects were allocated by the envelope method to either the HABITPRO group or the placebo group. Patients with severe undernutrition (Alb ≤2.5 g/dL) or those who were unable to gargle unaided were excluded from the study (Table Exclusion criteria.
Having severe undernutrition from before the start of treatment (Alb ≤2.5 g/dL)
Unable to gargle independently
Considered by an investigator to be unsuitable to participate in the study for any other reasons | PMC10728525 |
Evaluation parameters | carious bacteria, caries, tooth surface/total tooth, caries, periodontal disease, tooth | ADHESION, PERIODONTAL DISEASE, CARIES, PLAQUE |
Assessment of plaque adhesion status using the plaque control record (PCR).Measurements with a saliva analyzer (Sill‐Ha, Arkray Marketing Inc.).Plaque‐disclosing dye (Shofu Inc.) was used to dye all the remaining tooth surfaces, and the state of plaque adhesion on the surface in the cervical region was scored. The method of implementation was prescribed for four tooth surfaces (buccal, mesial, distal, and lingual/palatal) before and after intermaxillary fixation, and for three tooth surfaces (buccal, mesial, and distal) during intermaxillary fixation, and multiple clinicians were assigned without blinding. Records were recorded on a standardized paper chart, and the analysis was calculated as plaque‐positive tooth surface/total tooth surface × 100 and was evaluated by one person in a blinded fashion. The saliva analyzer uses patients' saliva to measure six parameters related to caries (carious bacteria, pH, and acid buffering capacity), periodontal disease (leukocyte count and protein levels), and oral cleanliness (ammonia levels). Specifically, saliva was collected after the mouth had been washed out with 3 mL of water for 10 s. Drops of saliva were placed on a special test paper, which was measured by the analyzer. The ammonia level was measured by the glutamate dehydrogenase assay. Measurements (1) and (2) were made at three time points: immediately before maxillomandibular fixation (baseline); on Day 10 of fixation; and immediately after fixation was released. There was individual variation between patients in the intraoral environment at baseline. Therefore, the amount of change in each measured value over time was calculated and compared. In this study, the primary outcome of this study was focused on PCR to evaluate oral hygiene status. Along with the primary outcome, six parameters related to caries, periodontal disease, and oral cleanliness in saliva were assessed. | PMC10728525 |
Statistical analysis | SECONDARY | JMP version 14 was used for statistical analysis. The primary and secondary endpoints were compared between the HABITPRO and placebo groups. Student's | PMC10728525 | |
RESULTS | PMC10728525 | |||
Study flow and baseline characteristics | The flow of patients throughout this study is depicted in Figure Flow diagram of patients throughout the study.Patient distribution.
| PMC10728525 | ||
The effectiveness of HABITPRO mouthwash on plaque control record | tooth | PLAQUE, DENTAL PLAQUE, PLAQUE | To assess the intraoral environment, the amount of dental plaque was evaluated using PCR as the primary endpoint. The PCR index varied widely at baseline. After fixation release, in the placebo group, the index increased by +24.61 compared with baseline, with an increase in the amount of plaque adhering to the teeth, whereas in the HABITPRO group, it was almost unchanged from baseline after fixation release, decreasing by –2.00 (Table Plaque control record.Abbreviation: IMF, intermaxillary fixation.
Representative intraoral photograph on Day 10 of fixation and after fixation release. Plaque‐disclosing dye was used to dye all the tooth surfaces. | PMC10728525 |
The effectiveness of HABITPRO mouthwash on salivary properties | caries, carious bacteria | PERIODONTAL DISEASE, CARIES | We investigated six parameters in saliva (carious bacteria, pH, acid buffering capacity, leukocyte count, protein levels, and ammonia levels) to verify whether HABITPRO mouthwash affects caries, periodontal disease, and oral cleanliness (Table Salivary properties.Abbreviation: IMF, intermaxillary fixation.
The buffering capacity of saliva increased similarly by +4.11 compared with baseline in the placebo group, but decreased by –10.07 in the HABITPRO group. However, this difference between the two groups was not significant. There were no significant differences between the two groups in pH, carious bacteria, leukocyte count, or protein levels at any time point. | PMC10728525 |
DISCUSSION | bad breath, caries, pain, mucositis, tooth | ADVERSE EVENTS, CARIES, ADHESION, PERIODONTAL DISEASE, MUCOSITIS, ASPIRATION PNEUMONIA | Recent years have seen rising interest in oral health management. Although the rate of mouthwash use is not necessarily higher in Japan than in other countries, it has tended to increase in recent years. Initially, most people thought that mouthwash was used to eliminate bad breath, and it was often lumped together with fragrances, so that rather than using it regularly, people tended to use it occasionally in a way that was greatly removed from the goal of health management. Recently, however, it has gradually come to be thought of differently, as awareness has spread of the necessity of oral function management. The main uses of mouthwash now include cleaning the mouth, retaining moisture, preventing caries and periodontal disease, and preventing bad breath.Since oral intake is not performed during maxillomandibular fixation, it is known that saliva secretion decreases and oral dryness becomes more severe. Additionally, it has been reported that oral bacterial flora changes during tube feeding, leading to an increase in aspiration pneumonia (Finucane & Bynum, The mouthwash investigated in this study is compounded with three medicinal ingredients. As a cationic surfactant, CPC exerts a bactericidal action by adsorption on the bacterial cell membrane, which increases its fluidity and causes it to break down (Hwang et al., In the present study, the effectiveness of this mouthwash was assessed in a specific environment resulting from maxillomandibular fixation. The results of the PCR experiments suggested that the use of a mouthwash containing active ingredients may suppress the adhesion of debris in comparison with the placebo group. During maxillomandibular fixation, all of the patients in this study carried out mechanical flossing with a Waterpik before using mouthwash. In both groups, the labial‐side tooth surfaces and mucosa were thus adequately cleaned by mechanical stimulation, but the present results showed that this alone was insufficient. The ammonia levels and buffering capacity of saliva were also affected by the mouthwash ingredients, despite Waterpik use. This may have been because the action of the Waterpik did not extend to the lingual‐side tooth surfaces or the tongue and other parts of the mucosa. A previous study found that the use of this mouthwash reduced debris adhesion to the sutures used in implant surgery, which supports the present results (Taninokuchi et al., Unlike oral medications, including antibiotics, mouthwash exerts direct local action to reduce systemic side effects. Therefore, mouthwash can be used continuously for a wide range of indications and used by a wide range of age patients. Barriers to the use of mouthwashes include irritation of the mucous membranes and their smell and taste. Therefore, taste and color can be important factors when choosing a mouthwash. In this study, the drug was used in patients ranging in age from 10 to 80 years and there were no adverse events such as mucositis or pain. In addition, there were no patients who were unable to use the product due to taste or odor preferences.The importance of oral management in the perioperative period is now recognized in both medicine and dentistry, and active interventions are now being performed (Bergan et al., During long‐term use, cost is another issue that must be resolved alongside taste preferences and irritation. The development of a versatile mouthwash for use not just in the perioperative period will be very important in terms of meeting a social need. | PMC10728525 |
CONCLUSIONS | The present results suggest that the continued perioperative use of a mouthwash containing active ingredients may suppress the deterioration of the oral environment to some extent, even in the specific environment resulting from maxillomandibular fixation. This mouthwash may therefore provide a tool for perioperative oral hygiene management. | PMC10728525 | ||
CLINICAL RELEVANCE | PMC10728525 | |||
Scientific rationale for the study | mandibular fracture | DENTAL CARIES, PERIODONTAL DISEASE, WOUND INFECTIONS, ASPIRATION PNEUMONIA, DISEASES | Management of the oral environment in patients with diseases of oral and maxillofacial region is very important to reduce not only the aggravation of dental caries and periodontal disease, but also local wound infections and aspiration pneumonia. Patients who required maxillomandibular fixation for the treatment of mandibular fracture or orthognathic surgery, a stronger oral environment management is required. Mouthwashes are used as a substitute for mechanical cleaning or in a supplementary role after such cleaning. fixation. However, little is known about the effectiveness of mouthwash in the specific environment created by maxillomandibular fixation. | PMC10728525 |
Principal findings | CPC/GK2/TXA‐based mouthwash reduced the ammonia level related to oral cleanliness in saliva and the PCR index after fixation release. | PMC10728525 | ||
Practical implications | The continued use of CPC/GK2/TXA‐based mouthwash may suppress the deterioration of the oral environment, even in the specific environment resulting from maxillomandibular fixation. This mouthwash may be useful in perioperative oral hygiene management. | PMC10728525 | ||
AUTHOR CONTRIBUTIONS | Yoshio Yamashita designed the study, Reona Aijima performed the experiments, all authors interpreted data, and Yoshio Yamashita wrote the manuscript. All authors reviewed the manuscript. | PMC10728525 | ||
CONFLICT OF INTEREST STATEMENT | The authors declare no conflict of interest. | PMC10728525 | ||
ACKNOWLEDGMENTS | The authors are grateful to participating staff members from the Department of Oral and Maxillofacial Surgery, Faculty of Medicine, Saga University. | PMC10728525 | ||
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10728525 | ||
REFERENCES | PMC10728525 | |||
Background: | hypertensive cerebral hemorrhage, hemiplegia, tibialis anterior muscle resistance | This study aimed to investigate the effect of tibialis anterior muscle resistance training on ankle and foot dorsum extension function in patients with hemiplegia caused by hypertensive cerebral hemorrhage. | PMC10403024 | |
Methods: | cerebral hemorrhage, hemiplegia, hypertensive | CEREBRAL HEMORRHAGE, CONTRACTION | Fifty cases of hypertensive cerebral hemorrhage in patients with hemiplegia were selected according to the random number table method. The patients were divided into the treatment group and control group. Each group included 25 cases, and the treatment group was given routine rehabilitation treatment and passive and active foot back stretch training (300 times/d). The control group received conventional rehabilitation treatment. The conventional rehabilitation treatment included stretching, muscle strengthening and other conventional rehabilitation treatment techniques. Surface electromyography was used to evaluate the muscle strength and tension of the triceps and tibialis anterior muscles of the affected side of the patients before and after treatment. The root mean square value of the surface electromyography (RMS) of the passive triceps extension before and after treatment was used to evaluate the muscle strength and tension of the affected side. The ratio of passive traction and relaxation of the triceps before and after treatment and the ratio of active contraction and relaxation of the tibialis anterior muscle before and after treatment were recorded. | PMC10403024 |
Results: | There was no significant difference in surface electromyography between the 2 groups before treatment ( | PMC10403024 | ||
Conclusions: | hypertensive cerebral hemorrhage, hemiplegia, Tibialis anterior muscle resistance | Tibialis anterior muscle resistance training can effectively improve the strength of the tibialis anterior muscle in patients with hemiplegia caused by hypertensive cerebral hemorrhage, reduce tension in the triceps calf muscle, and improve ankle joint function and foot dorsum extension. | PMC10403024 | |
1. Introduction | cerebral hemorrhage, Stroke, stroke, hemiplegia, strokes | CEREBRAL HEMORRHAGE, STROKE, STROKE, ISCHEMIC STROKE, STROKES | Stroke is a common and frequently occurring condition in clinical practice. The incidence of cerebral hemorrhage in all stroke subtypes is second only to that of ischemic stroke. According to a domestic epidemiological survey, the proportion of cerebral hemorrhage in China is higher than that in Western countries, accounting for 18.8% to 47.6% of strokes,Improving ankle and foot dorsum extension function and the gait of patients with foot drop,Currently, the main treatments for hemiplegia are exercise therapy, forced exercise therapy, acupuncture, and physiotherapy. | PMC10403024 |
2. Clinical data | PMC10403024 | |||
2.1. Case selection criteria | tibial anterior muscle, consciousness disorders, lower limb dysfunction, liver and kidney dysfunction, intracerebral hemorrhage, cerebral hernia, amputation, cord injury, vertigo, balance dysfunction, infection, hypertensive, coagulopathy, vestibular dysfunction, aphasia, venous thrombosis, trauma | MYOCARDIAL INFARCTION, INTRACEREBRAL HEMORRHAGE, DISEASE COURSE, HEMATOLOGICAL DISEASES, JOINT DISEASES, CEREBELLAR LESIONS, INFECTION, HYPERTENSIVE INTRACEREBRAL HEMORRHAGE, VENOUS THROMBOSIS, COAGULOPATHY, COMPLICATIONS, NEOPLASTIC DISEASE | In accordance with the diagnosis of hypertensive intracerebral hemorrhage, the diagnostic criteria refer to the diagnostic criteria of the Chinese Multidisciplinary Diagnosis and Treatment Guidelines for hypertensive intracerebral hemorrhageInclusion criteria were as follows: patients aged 30 to 70 years, patients who met the diagnostic criteria for hypertensive intracerebral hemorrhage and were diagnosed with unilateral involvement on computed tomography or magnetic resonance imaging, the disease course was >6 months, vital signs were stable, neurological symptoms were no longer progressive, consciousness was clear, and the patient could cooperate with the command movement, and the muscle strength of the tibial anterior muscle decreased, and the muscle strength was evaluated as grades 1 to 5 according to the free-hand manual muscle testing grading method. All patients and their family members agreed to participate in the study and voluntarily signed informed consent forms.The exclusion criteria were as follows: patients with unstable vital signs or severe complications (cerebral hernia, myocardial infarction, severe liver and kidney dysfunction, severe infection, or venous thrombosis of both lower extremities), patients with intracerebral hemorrhage caused by trauma, coagulopathy, hematological diseases, or neoplastic diseases were excluded. Patients with consciousness disorders, sensory aphasia, etc., patients with other conditions of lower limb dysfunction (spinal cord injury, amputation, severe bone and joint diseases, etc.), and patients with conditions that cause balance dysfunction (vertigo, vestibular dysfunction, cerebellar lesions). | PMC10403024 |
2.2. General data | blood loss, craniocerebral injury | BLOOD LOSS, DISEASE | A total of 50 patients with craniocerebral injury were admitted to the Department of Neurosurgery, and the sample size was determined by referring to previous similar randomized controlled experiments. Patients from the Second People’s Hospital of Yibin from January 2020 to January 2022 were selected and divided into treatment and control groups according to the random number table method with 25 cases in each group. This study was approved by the ethics committee of the Second People’s Hospital of Yibin. There were no significant differences in sex, age, course of disease, blood loss, muscle strength, or muscle tension between the 2 groups (Comparison of general data between 2 groups ( | PMC10403024 |
3. Method | PMC10403024 | |||
3.1. Treatment methods | cramps, knee ankle foot orthoses or ankle foot | Methods rehabilitation training was carried out by the same group of rehabilitation therapists.The control group was given conventional rehabilitation techniques such as stretching, muscle strength, balance and wearing orthoses. According to the actual movement function in patients with grade wearing knee ankle foot orthoses or ankle foot orthoses, training content included physical therapy (passive training, sit-ups, bridge type double lower limb joint movement, roll over training, seat, aided by sitting and standing balance training, orthoses wear to take off the train, aided by up and down the stairs and training), trunk core muscle group training, acupuncture and moxibustion treatment, cramps machine, etc. The training was performed once a day for 30 minutes each time for 8 weeks.The treatment group included passive and active dorsalis pedis training 300 times/d and was divided into 3 to 5 groups according to the degree of tolerance of children and their families. Each group had 60 to 100 points to complete 3 to 5 times a day, with a routine rehabilitation training and training cycle for 8 weeks. Muscle strength was evaluated as grades 1 to 5 according to the free-hand manual muscle testing grading method. Grades 1 and 2 were trained with active exercise plus a lot of auxiliary exercise; grades 3 and 4 were trained with active exercise plus a little resistance exercise; and grade 5 was trained with active exercise plus a lot of resistance exercise. | PMC10403024 | |
3.2. Observation indices | Before treatment and 2 months after treatment, the electromyography (EMG) of the affected side of the tibialis anterior and peroneus longus muscles was recorded using the SA7550 surface EMG analysis system produced by Nanjing Weis Medical Co., Ltd. Before and after treatment, the root mean square (RMS) value of the triceps leg passive extension,During the evaluation, the patient rested quietly for 5 minutes, the room temperature was approximately 30 to 35 °C, the lower limbs were placed in an upright sitting position, the lower legs were exposed, the skin was wiped with alcohol, the triceps electromyography electrode was connected, and the tibialis anterior and triceps muscles were fully extended. The tibialis anterior and triceps muscles are channels A and B, respectively.The muscles of channel A were actively contracted in the following steps: contract, relax, contract, relax, contract, and relax.The channel B muscles passive draft were the following: pull, relax, pull, relax, pull, and relaxThe SEMG signal was collected, and the system automatically analyzed the root-mean-square value of the surface EMG signal. | PMC10403024 | ||
3.3. Statistical analysis | SPSS17.0 software (International Business Machine, Armonk, NY) was used to analyze SPSS data. The data did not conform to a normal distribution; therefore, the nonparametric rank sum test (Mann–Whitney IQR comparison of treatment data between the 2 groups (IQR).IQR = interquartile range. | PMC10403024 | ||
4. Results | PMC10403024 | |||
4.1. Comparison of patients before and after training | hypertensive cerebral hemorrhage, cerebral hemorrhage, hemiplegia | CEREBRAL HEMORRHAGE | Twenty-five patients were enrolled in the experimental group, and 24 patients were enrolled in the control group. One patient in the control group had another sudden cerebral hemorrhage after enrollment, so he dropped out halfway. In the treatment group, the RMS difference in triceps crus passive extension before and after treatment and the ratio difference in RMS between passive extension and relaxation of the triceps crus were significantly lower than those in the control group (Resistance training can improve the strength of the tibialis anterior muscle, reduce the tension of the triceps calf muscle, and improve ankle and foot dorsum extension function in patients with hemiplegia caused by hypertensive cerebral hemorrhage. In addition, this exercise is easy for patients to learn and master and can reduce medical expenses. | PMC10403024 |
5. Discussion | PMC10403024 | |||
5.1. Passive traction SEMG data of the triceps crus in both groups are presented in the third row of | tibialis anterior muscle, stroke | STROKE, CONTRACTION | Compared with the observation group, the SEMG of the treatment group was higher.The treatment group was 9.33 (88.44–7.47) and the control group was 4.17 (27.3–6.64).The difference between the 2 groups was statistically significant (The surface electromyography during passive traction of the triceps crus indicated triceps crus muscle tension. The above data showed that the triceps calf muscle tension of the treatment group was lower than that of the observation group, and the difference was statistically significant.Ratio of passive extension to passive relaxation SEMG data of the triceps crus in the 2 groups are presented in Row 4 of Table Compared with the observation group, the value of the treatment group was higher.The treatment group 3.05 (5.99–1.09).The control group 0.07 (2.57–0.68).The difference between the 2 groups was statistically significant (To reduce the measurement error, the triceps calf muscle tension in the treatment group was lower than that in the observation group, and the above data showed that the triceps calf muscle tension in the treatment group was lower than that in the observation group, and the difference was statistically significant.Row 5 of Table Compared with the observation group, the EMG of the treatment group was higher.The treatment group was 24.17 (9.40–28.7) and the control group was 5.24 (0.40–16.09).The difference between the 2 groups was statistically significant (The surface electromyography during the active contraction of the anterior tibial muscle suggested the strength of the anterior tibial muscle. The above data showed that the strength of the anterior tibial muscle in the treatment group was higher than that in the observation group, and the difference was statistically significant.Row 6 of Table Compared with the observation group, the value of the treatment group was higher.The treatment group was 13.79 (2.53–33.7) and the control group was 2.19 (1.1–33.7).The difference between the 2 groups was statistically significant (The comparison of the data obtained during active contraction of the tibialis anterior muscle with the data obtained during relaxation was performed to reduce measurement error. The above data showed that the muscle strength of the tibialis anterior muscle in the experimental group was higher than that in the observation group during active contraction, and the difference was statistically significant.Hemiplegia patients’ high leg triceps muscle tension is one of the main factors that limits walking.This is related to the high frequency of intensive training. The training frequency of conventional rehabilitation training for the tibialis anterior muscle is often less than 100 times per day, while the training frequency designed in this study is 300 times per day, which is several times higher than that of conventional rehabilitation training, and the high frequency of intensive training can improve patients’ limb control.This study is similar to the article by Yoo DY from Korea “Impact of intensive rehabilitation on long-term prognosis after stroke: A Korean nationwide retrospective cohort study,” which shows that intensive rehabilitation has long-term positive effects on stroke patients.The intensive training method designed in this study is simple and easy to learn, and patients or their family members can master it proficiently after training. Patients can train independently at any time, with strong active participation. However, routine rehabilitation training involves many complex movements, in which patients and their family members have a limited grasp of the training, and active participation is weak. The rehabilitation effect of patients with good active participation is better than that of patients with weak active participation.Hemiplegia requires long-term treatment, and many patients cannot be treated in medical institutions for a long time. After mastering this intensive training method, patients and their family members can train at home by themselves, which can reduce medical expenses and the risk of poverty caused by illness.However, intensive training of the tibialis anterior muscle requires a high degree of cooperation among the patients, therapists and their families. During training, concentration should be on the muscle, movement should be slow, patients’ tolerance should be taken as appropriate, and overtraining should not aggravate the injury of patients. | PMC10403024 |
5.2. Limitations of the study | stroke, hemiplegic | STROKE | This study had the limitation of a small sample size of stroke patients from a single medical center, which does not provide a population-based representation of stroke patients. Additionally, we did not observe the recovery of foot dorsiflexion in patients with longer workouts. In the future, larger multicenter studies could be performed. The long-term efficacy of the treatment and the function of foot dorsiflexion in hemiplegic patients were observed. | PMC10403024 |
6. Conclusions | tibialis anterior muscle resistance, hemiplegic | In conclusion, based on routine rehabilitation training, tibialis anterior muscle resistance training for hemiplegic patients can improve walking ability, reduce treatment costs, and facilitate home rehabilitation training, which is worthy of clinical promotion and application.This study has some limitations. For example, the sample size included in this study was small, which was not sufficient to represent the situation of all patients. Larger sample sizes and more in-depth research are expected in the future. | PMC10403024 | |
Abbreviations: | tibialis anterior muscle resistance, hypertensive cerebral hemorrhage hemiplegia | electromyographyroot mean squaresurface electromyographyThis study was supported by Qiaoliang Li.All patients provided written informed consent.This trial was approved by the Institutional Review Board of the Second People’s Hospital of Yibin City (Approval Number: 2021-008-01).The authors have no conflicts of interest to disclose.The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.How to cite this article: Li Q, Chen L. Effect of tibialis anterior muscle resistance training on ankle and foot dorsum extension function in hypertensive cerebral hemorrhage hemiplegia patients: A randomized controlled trial. Medicine 2023;102:31(e33827). | PMC10403024 | |
References | PMC10403024 | |||
Objectives: | To ascertain the use of draining the thyroid bed following surgery. | PMC10187750 | ||
Methods: | pain | COMPLICATIONS | Fifty four patients who underwent total thyroidectomy were enrolled in the study between March 2021 and July 2022 and randomly allocated into 2 groups – a drain group and a no drain group. The hospital stay, operating time, post operative pain, post operative complications, cosmesis, and patient’s perspectives were compared. | PMC10187750 |
Results: | Pain, pain | SCARRING, COMPLICATIONS | The mean duration of hospitalization was significantly shorter in the no drain group as compared to the drain group. The post operative pain, as assessed by the Mankoski Pain Scale (MPS) was significantly higher in the drain group than in the no drain group. The cosmetic evaluation undertaken using the Hollander Wound Evaluation Scale, noted that there was a statistically significant difference in scarring between the 2 groups. There was no statistically significant difference in the duration of surgery and post operative complications between the two groups. Patient satisfaction was also noted to be superlative in the no drain group. | PMC10187750 |
Conclusion: | pain | The routine drain placement following thyroidectomy places the patient at a disadvantage in terms of longer hospitalisation, increased post operative pain and poor cosmetic outcome. | PMC10187750 | |
Keywords: | pain |
While the routine use of drains following thyroidectomy remains a controversial and highly debated topic, the goal of our study was to test the hypothesis that thyroid surgeries performed without the routine usage of drains are more productive than those performed with drains as they decrease the duration of hospital stay, post operative pain and are also associated with better cosmesis. | PMC10187750 | |
Methods | thyroid swelling | THYROTOXICOSIS, BLEEDING DIATHESIS | A prospective, randomized study was carried out on 54 patients for 18 months from March 2021 to July 2022. We included patients of both genders of all age groups in a euthyroid state with clinically proven and cytologically diagnosed thyroid swelling requiring surgical removal. The exclusion criteria were patients with thyrotoxicosis, on anticoagulants, bleeding diathesis, with huge thyroids more than 6 cm and patients for whom lateral neck dissection was required. They were evaluated using ultrasound neck, thyroid hormone profile (FT3, FT4, TSH), fine needle aspiration cytology (FNAC), Indirect Laryngoscopy and routine pre-operative blood investigations, which included a complete hemogram with coagulation profile, renal and liver function tests, serum electrolytes, serology, urine routine, chest x-ray, neck x-rays, and electrocardiogram (ECG). In addition, the pre-operative evaluation also included 2D echo and pulmonary function tests (PFTs) in applicable patients. Informed consent for surgery and participation in the study was obtained from the patient. A senior surgeon operated on all the patients with strict adherence to intraoperative surgical protocols. Thorough hemostasis and meticulous closure was followed to identify and preserve recurrent laryngeal nerves. Intraoperatively, the patients were allocated using the block randomization method into the drain group (Group A, - Post operative image of patient in the drain group.- Post operative image of patient in the no drain group.The study was carried out in accordance with the 1964 Declaration of Helsinki and its subsequent amendments or comparable ethical standards. The protocol of the study was approved by the Institutional Review Board and the Ethics Committee of our hospital. | PMC10187750 |
Statistical analysis | The data obtained was documented in a standard proforma, analyzed using the Microsoft Excel software and incorporated into Statistical Package for Social Sciences, version 22 (IBM Corp., Armonk, NY, USA). Continuous variables were shown as mean ± standard wherever appropriate. The results were considered as statistically significant when | PMC10187750 | ||
Results | SD | COMPLICATIONS | Based on selection criteria, 54 patients were enrolled in the study of which there was a definite female preponderance at 51 female and 3 male patients who underwent total thyroidectomy. The mean age of the patients was 44.8±6.1 (range 34-57 years). The mean duration of surgery was 68.1 minutes (SD ±9.3) in the drain group, while it was 67.4 minutes (SD ±10) in the non-drain group. There was no significant association between the groups (- Post-operative complications among patients with and without post-operative drains following total thyroidectomy.The patients in whom drains were placed experienced a longer duration of hospitalization (mean 3.0±0.6) as compared to non-drain patients (mean 2.2±0.5). This difference was statistically significant ( | PMC10187750 |
Discussion | bleeding, postoperative pain, thyroid disease, pain, seroma, hematoma | BLEEDING, SCAR, THYROID DISEASE, WOUND INFECTION, COMPLICATION, SITE INFECTION, SEROMA, NECK HEMATOMA, SCARRING, HEMATOMA, COMPLICATIONS | The practise of general surgery has thyroid surgery at its core. Although the customary use of drains following thyroidectomy has been the subject of ongoing dispute, most surgical departments worldwide have a uniform practise of draining the thyroid bed following thyroidectomy. According to prevailing theory, suction drainage limits the build-up of lymphatic and bleeding secretions, decreasing the possibility of neck hematomas and surgical site infections.The study’s results demonstrated that the duration of hospitalization, 24 hours (hrs) post-operative pain, and post-operative wound cosmesis were significantly higher in the drain group compared to the non-drain group. In our research, we discovered that post-operative pain was more common in the drain group, which we hypothesise may be related to the aggravating aspect of having a drain installed. Although the duration of surgery, 72 hrs post-operative pain, post-operative complications of hematoma, seroma and wound infection were higher in the drain group, they did not vary significantly. A key parameter that we have assessed in our study is the cosmetic outcome following surgery. In the present era of minimally invasive and scarless surgery, every surgical wound counts particularly in thyroid disease that predominantly affects females. Drain placement attributes to an additional scar on the exposed part of the neck.The complication rate following thyroid surgery is very surgeon specific. A meticulously operated thyroid with thorough attention to hemostasis ensures a virtually complication free post operative outcome. A drain does not serve as a proxy for these factors. Sosa et alThe results of our study corroborates with one carried out by Emmi and Reddy- Comparison of Post-operative wound scarring using the Hollander Wound Evaluation Scale among patients with and without post-operative drains following total thyroidectomyPortinari and CarcoforOur study did not reveal any significant benefits in placing drains following thyroid surgery. The hospital stay and postoperative pain was significantly lower for patients without drains. The cosmetic outcome was improved and the patients registered a greater satisfaction level without drain placement. | PMC10187750 |
Study limitation | pain | SCARRING, POSTOPERATIVE COMPLICATIONS | The small sample size of our study invariably limits the statistical significance of the results. No significant correlation could be established between the rates of postoperative complications and drains. Larger sample size and multicentric studies can be carried out to further evaluate the necessity of drain placement.In conclusion, this prospective research was carried out to evaluate, collect further evidence, and gain additional knowledge on the significance of routine usage of the drain. We observed that post-operative pain during the first 24 hours was significantly more common in the drain group. The other significant observations were the drain group’s longer duration of hospitalization and post-operative scarring. Since earlier discharge is made possible for patients without drain, it always reduces the patient’s hospitalization costs. Additionally, patients are extremely concerned about post-surgical scars after any surgical operation. Lesser scarring is associated with better treatment outcomes. | PMC10187750 |
Acknowledgment | PMC10187750 | |||
References | PMC10187750 | |||
Background | neoplasia | NEOPLASIA, TYPE 2 DIABETES MELLITUS, CARDIOVASCULAR DISEASES | The high proportion of people with overweight and obesity has become a worldwide problem in recent decades, mainly due to health consequences, such as cardiovascular diseases, neoplasia, and type 2 diabetes mellitus. Regarding effective countermeasures, the digitization of health services offers numerous potentials, which, however, have not yet been sufficiently evaluated. Web-based health programs are becoming increasingly interactive and can provide individuals with effective long-term weight management support. | PMC10337343 |
Objective | weight loss | The purpose of this randomized controlled clinical trial was to evaluate the effectiveness of an interactive web-based weight loss program on anthropometric, cardiometabolic, and behavioral variables and to compare it with a noninteractive web-based weight loss program. | PMC10337343 | |
Methods | The randomized controlled trial included people who were aged between 18 and 65 years (mean 48.92, SD 11.17 years) and had a BMI of 27.5 to 34.9 kg/m | PMC10337343 | ||
Results | The intervention group showed significant improvements in anthropometric variables, such as body weight ( | PMC10337343 | ||
Conclusions | The interactive web-based health program was effective in reducing body weight and improving body composition in adults with overweight and obesity. However, these improvements were not associated with relevant changes in cardiometabolic variables, although it should be noted that the study population was predominantly metabolically healthy. | PMC10337343 | ||
Trial Registration | German Clinical Trials Register DRKS00020249; https://drks.de/search/en/trial/DRKS00020249 | PMC10337343 | ||
International Registered Report Identifier (IRRID) | RR2-10.3390/ijerph19031393 | PMC10337343 | ||
Introduction | obesity, weight loss | OBESITY, ASSOCIATED DISEASE, DISEASES | The past decades have been characterized by a sharp increase in BMI [Although there are specific and evidence-based dietary and physical activity recommendations to prevent and treat obesity and its associated comorbidities, these behaviors often cannot be implemented and established in the long term. Systemic and environmental drivers have a lasting effect on behavior and make long-term behavior change difficult [In addition to potential solutions from nutrition or sports science, ways to improve preventive and therapeutic lifestyle interventions to counter the global trend of rising BMI and associated comorbidities are also being sought at the level of the delivery medium used. It is now well established that face-to-face lifestyle interventions can be effective in preventing and treating obesity and its associated diseases [Despite promising approaches, the effectiveness of web-based interventions is still under debate. In particular, longer-term effects and interactive web-based interventions require further investigation [Using interactive web-based interventions and addressing dietary energy density are considered 2 potential approaches for successful weight management, but to the best of our knowledge, they have not been studied in combination. The purpose of this randomized controlled clinical trial was to investigate the effectiveness of an interactive and fully automated web-based weight loss program focusing on dietary energy density in adults with overweight and obesity. Therefore, the study compared interactive and noninteractive web-based interventions, as both interventions have an unlimited reach and availability due to the lack of human involvement. We hypothesized that the interactive program would result in statistically significant improvements with small to medium effect sizes. Moreover, we assumed that these improvements would be significantly more pronounced in the interactive program than in the noninteractive program. The interactive weight loss program is part of a multimodal health program developed by a German health insurance company. This multimodal health program addresses individual health goals, such as weight loss, physical fitness, healthy eating, and smoking cessation. The different modules provide an individually tailored health intervention depending on the health goal and status. Each of the modules enables interactive health intervention for the prevention of noncommunicable diseases via selectable activities and corresponding feedback. This clinical substudy is part of an evaluation of a German-language web-based lifestyle intervention coordinated by the Section for Health Services Research and Rehabilitation Research (SEVERA) at the University Medical Center Freiburg [ | PMC10337343 |
Methods | PMC10337343 | |||
Study Protocol | The main methodological points of this randomized controlled clinical trial with relevance to this paper are described below. A detailed description of the study methods can be found in the study protocol, which has already been published [ | PMC10337343 | ||
Study Design | weight loss, Universität zu Lübeck) [ | Study participants in the online questionnaire study “weight loss” who were living in southwest Germany (postcode area: 79) were additionally invited to the Department of Sport and Sport Science of the University of Freiburg for the clinical substudy [The study included intervention and control groups with automated randomization after completing the questionnaire at t0. Permuted block randomization was performed to obtain an approximately equal distribution in both study groups. Variable block sizes of 4, 6, and 8 were used for this purpose. The allocation sequence was created by SEVERA using RITA software (Version 1.50; Universität zu Lübeck) [ | PMC10337343 | |
Participants | RECRUITMENT | Participants aged 18 to 65 years in the online questionnaire study and residing in southwest Germany were additionally eligible to participate in the clinical substudy. The inclusion criteria for the clinical trial were a BMI of 27.5 to 34.9 kg/mRecruitment of the participants took place online and offline through various media, such as local newspapers, flyers, and Google advertisements. Through the various recruitment media, interested individuals were directed to an open-access landing page. On the landing page, people were able to find out about the study and register. Written informed consent was obtained for registration. After registration, automatic randomization was performed immediately, and the clinical substudy staff contacted the prospective study participants. During the contact, information about the study was provided again, the inclusion and exclusion criteria were verified, and an appointment was made for the first medical examination. With the successful completion of the first medical examination, the study enrollment was completed. As an incentive, participants in the clinical trial received an activity tracker, which also served as a measurement tool to record physical activity. Specific information on sample calculation and recruitment can be found in the detailed study protocol [ | PMC10337343 | |
Intervention | weight loss | STAGGERED | Both interventions were fully automated and without human involvement. The intervention group received an interactive web-based health program. The multimodal web-based health program could provide personalized intervention depending on health goals. The web-based health program was frozen for the evaluation to create a consistent study version. For this study, all participants in the intervention group received the health program’s weight loss module. This module of the health program runs for 12 weeks and aims to achieve long-term behavior change. The 12-week intervention was divided into 3 phases. In phase 1, users should try out and get to know the program (weeks 1-3). In phase 2, consolidation of the new behavior should occur (weeks 4-6). In the final phase 3, the new habits should be strengthened (weeks 7-12). Despite this division, the program was freely usable and did not follow a linear sequence. All information texts, videos, and activities could be accessed at any time, allowing the program to be used according to individual pace or need.The focus of the interactive weight loss program was on reducing dietary energy density. For this, the program offered the possibility to log the diet and receive feedback accordingly in terms of energy density, energy intake, and macronutrients. The primary goal was not to have the participants lose as many kilograms as possible in terms of a crash diet. Rather, the goal was to achieve relatively slow weight loss, thereby primarily losing fat mass and maintaining the resting metabolic rate [In addition to this interactive content, there was an extensive knowledge area. This knowledge area included evidence-based articles on dietary energy density, healthy eating, and weight loss. Some of these articles were part of a weekly task and were staggered throughout the 12-week intervention. Besides the evidence-based information, the intervention offered a comprehensive collection of recipes to support users in practical application.In contrast, the control group received noninteractive web-based information on how to lose weight by lowering dietary energy density while eating healthy. This noninteractive information was transmitted by short articles and was intended to serve the transfer of knowledge. This was a static intervention, meaning that no change in content occurred over the course of the 12 weeks.Both groups were allowed to use or rerun their program following the 12-week intervention period. Thus, the corresponding program was freely available during the follow-up. Further details about the intervention can be found in the study protocol [ | PMC10337343 |
Outcome Variables | BLOOD, SECONDARY | The primary outcome of the study was body weight. This was measured using the validated bioelectrical impedance scale Seca mBCA 515 (Seca GmbH & Co KG) [In addition, behavioral and physiological variables were defined as secondary outcomes. In the behavioral domain, dietary and physical activity behaviors were recorded. Seven-day dietary records were generated at each of the 4 measurement time points using NutriGuide Plus software (Version 4.8; Nutri-Science GmbH). Energy intake, dietary energy density (excluding beverages), and macronutrients were evaluated using the dietary data. Physical activity was assessed using the activity tracker Fitbit Charge 3 (Fitbit, Inc) and the long version of the International Physical Activity Questionnaire (IPAQ-L; German) [In addition to the primary outcome of body weight, other anthropometric variables were measured or calculated. Thus, body height, BMI, waist circumference, fat mass, and fat-free mass were recorded using the bioelectrical impedance analysis scale Seca mBCA 515, the stadiometer Seca 274, and the measuring tape Seca 201 (Seca GmbH & Co KG). Blood samples were collected, and blood glucose (fasting glucose and glycated hemoglobin [HbA | PMC10337343 | |
Data Analysis | PBC | R (Version 4.1.3; R Core Team) and R Studio (Version 2021.09.1; Posit PBC) were used for statistical analysis and creation of the graphs. Statistical analysis of all variables was performed with robust linear mixed models using the R packages lme4 [Per-protocol (PP) and intention-to-treat (ITT) analyses were performed. In the PP analysis, only subjects without missing values for the respective variable were included (complete cases). If missing data were available for individual outcomes, fewer study participants were considered accordingly. In the ITT analysis, all randomized cases were included. Missing values were imputed by multiple imputation (n=50) using the R package micemd [ | PMC10337343 | |
Ethical Considerations | MINOR | This study followed the principles of the Declaration of Helsinki. The study was approved by the Ethics Committee of the University of Freiburg on July 25, 2019 (vote number: 237/19). A clinical pilot study was conducted (vote number: 409/18, DRKS00016512), resulting in minor changes to the study protocol. These changes were positively assessed by the Ethics Committee (date of approval: October 22, 2019; protocol version: amendment 01). Written informed consent was provided by all participants prior to study inclusion. | PMC10337343 | |
Results | PMC10337343 | |||
Participants | RECRUITMENT, RECRUITMENT | Recruitment of participants took place from January 2020 to July 2020. During this period, 257 interested individuals registered for the clinical substudy. After screening (telephone interview and preliminary examination), 153 subjects were included in the study, and they completed the baseline measurement. There were 35 dropouts throughout the study. None of the health reasons of the dropouts were associated with the intervention. Since 4 study subjects did not attend the t2 examination due to the COVID-19 pandemic, they could not be included in the PP analysis (complete cases). The study participant flow is shown in Flow chart depicting participant recruitment and dropout. t2: 6-month follow-up.Baseline (t0) characteristics of the study participants. | PMC10337343 | |
Discussion | loss of fat-free mass, muscle mass, weight loss, fat-free mass | The main finding of this study was that the interactive web-based health program focusing on dietary energy density showed positive effects on body weight, fat mass, and waist circumference. These effects were significantly more pronounced in the intervention group than in the control group with only web-based knowledge transfer and were also evident in the longer-term 12-month follow-up period. With regard to short-term weight loss from web-based interventions (3-4 months), comparable interventions reported short-term weight loss of 2.0 kg [Fat mass in the intervention group decreased significantly compared with the finding in the control group over the course of the study, whereas fat-free mass reduced in the intervention group, but did not differ between the 2 groups. Both of these are important findings because few web-based interventions perform body composition measurements and most use self-reported parameters. This limits the accuracy of the measurements and does not provide direct information regarding the loss of body fat. Moreover, it is known that weight loss interventions can result in a loss of fat-free mass and muscle mass [The effectiveness of the interactive web-based health program was also partially evident in behavioral variables, such as energy density, energy intake, fat intake, and self-reported physical activity. Based on the focus of the program, the reduction in energy density in the short and long term in the intervention group was an important finding. Energy intake developed consistently with energy density in the intervention group, although the effect was significant only in the short term. The increase in energy density at t2 in both groups could be due to a seasonal effect [Despite the positive effects on body weight and composition, the improvements in cardiometabolic variables in the intervention group were small and not significantly superior to the findings in the control group. For some variables, such as systolic and diastolic blood pressure, improvements were similar to those with other web-based interventions, whereas LDL cholesterol showed a worse trend [The results of this study confirm the benefits of lowering energy density shown by several previous studies in relation to weight loss [Several limitations must be considered in this study. First, complete blinding was not possible due to the recognition of the program by the participants. Therefore, the motivation of the participants might have been influenced based on the recognition of the program. Second, both study groups might have been additionally motivated to attain their health goals by interest in free medical examinations as well as activity trackers received as incentives. Conversely, the participants of the clinical substudy might have been more motivated than the participants of the online study already at the beginning, since participation in medical examinations required more commitment. Third, the effect of the COVID-19 pandemic on both groups was difficult to quantify. Qualitative feedback from study participants indicated that the COVID-19 pandemic and its associated restrictions affected people positively, negatively, or not at all with regard to their weight management, dietary, or physical activity behaviors. Descriptive examinations of physical activity during the first lockdown in March 2020 showed, on average, negligible change in measured physical activity. Fourth, nonuse might have affected the effectiveness of the program and the study results. Overall, however, the usage analysis showed that the program was used multiple times by all participants in the intervention group of this study (data not shown). Because the control group received only web-based information without updates, one-time use was expected. However, despite these limitations, this study provides evidence that an interactive and fully automated web-based health program focusing on energy density concepts exerts positive effects on weight loss among people with overweight and obesity. The standardized measurement of body weight and clinical variables in this study, compared with the self-reported measurement of body weight in other studies, is a strength of this study. Owing to the potentially unlimited availability of fully automated web-based programs, there may be relevant public health effects.This clinical study showed that an interactive web-based weight loss program was effective and superior to a noninteractive web-based weight loss program. The interactivity of web-based interventions seems to play an important role in effectiveness. Based on the present results, pure knowledge transfer is not sufficient to induce sustainable weight loss and adherence to a diet with low energy density. In the web-based intervention studied here, interactivity was established via feedback on dietary documentation and activities achieved or not achieved. Future research should consider in more detail what and how much interactivity is necessary to make web-based weight loss interventions effective. Nevertheless, our results suggest that integrating the concept of a diet with low energy density into an interactive web-based weight loss program is useful for achieving weight loss.The project was funded by Techniker Krankenkasse (German Health Insurance Company). The project funder had no influence on the planning and implementation of the study, the analysis and interpretation of the data, or the publication of the results. We thank all study participants in the clinical weight loss trial as well as all study staff who made the implementation possible. In addition, we would like to thank Techniker Krankenkasse, represented by Nicole Knaack, Kerstin Hofreuter-Gätgens, and Dagmar Köppel, for funding this study. Additionally, we would like to thank Irina Kopman and her team at Vilua Healthcare GmbH for IT support. We also acknowledge support by the Open Access Publication Fund of the University of Freiburg.Authors' Contributions: JK, JB, RW, RF, MS, IT, PM, UAF, CA, EFG, AG, and DK contributed to the conception and design of the study and methodology. JK, JB, and DK were in charge of the project administration. JK, JB, CC, and MS performed the statistical analysis. JK wrote the first draft of the manuscript. All authors contributed to the manuscript revision, and read and approved the submitted version.Conflicts of Interest: The Department of Sport and Sport Science (JK, JB, RW, DK, and RF) and Section for Health Services Research and Rehabilitation Research (SEVERA) (MS, IT, EFG, CA, UAF, and PM) were commissioned by Techniker Krankenkasse (German Health Insurance Company) for the scientific evaluation of the web-based health program. JK, JB, and DK report funding from Techniker Krankenkasse for clinical trial design, implementation, and scientific evaluation. CC and AG declare that they have no conflicts of interest. RW, RF, MS, IT, EFG, CA, UAF, and PM report funding from Techniker Krankenkasse for the design, implementation, and scientific evaluation of the online trial.Effect sizes of anthropometric variables (intention-to-treat analysis).Results of the robust linear mixed model of behavioral variables (intention-to-treat analysis).Effect sizes of behavior variables (intention-to-treat analysis).Effect sizes of cardiometabolic variables (intention-to-treat analysis).Results of the robust linear mixed model of cardiometabolic variables (intention-to-treat analysis).CONSORT EHEALTH Checklist (V 1.6.1). | PMC10337343 | |
Abbreviations | high-density lipoproteinlong version of the International Physical Activity Questionnaireintention to treatlow-density lipoproteinper protocolSection for Health Services Research and Rehabilitation Research | PMC10337343 | ||
Data Availability | The data sets generated during or analyzed during this study are available from the corresponding author on reasonable request. | PMC10337343 | ||
1. Introduction | TBI, traumatic brain injury | This pilot study assessed the feasibility of using SwapMyMood, a smartphone application supporting evidence-based strategies for emotion regulation and problem-solving as a supplement to conventional care for military service members and veterans (SM/Vs) experiencing chronic symptoms of mild traumatic brain injury (mTBI) and co-occurring psychological conditions. Eight military SM/Vs were recruited from an intensive outpatient program. Participants were block randomized to an experimental group (conventional care plus use of the SwapMyMood app) or a conventional care only group for six weeks. Conventional care included instruction on problem-solving and emotion regulation strategies using traditional paper manuals and protocols. Effects on the knowledge and use of strategies and related goal attainment were measured. Patient-reported outcomes were measured via several validated problem-solving and emotion regulation scales. No differences were found between groups in goal attainment, global executive function, problem-solving, emotion regulation, and knowledge of how to use the problem-solving and emotion regulation strategies targeted. Experimental group participants rated the application positively, demonstrating feasibility of integration of the app into clinical care. The implementation of SwapMyMood is feasible in a clinical setting. SwapMyMood may be a clinically effective supplemental tool for supporting executive function in SM/Vs with mTBI and co-occurring psychological conditions.Between 2000 and 2022, 458,894 military service members were diagnosed with traumatic brain injury (TBI), with the majority being mild TBI (mTBI) [Several studies support the use of interventions that concurrently address cognition and co-occurring psychological conditions following mTBI, including the use of metacognitive strategy instruction (thinking about one’s thinking) [Barriers to the successful use of interventions by individuals with TBI include lack of access to the recommended frequency of treatment and challenges applying interventional tools to environments outside of supportive treatment settings [SwapMyMood addresses barriers to traditional metacognitive strategy instruction by offering personalized solutions to individualized challenges that have shown to be effective for real-time situational coping. It supports users in recalling and implementing multi-step, executive functioning strategies. The app also provides feedback about actions that have previously been successful in helping the user with problem-solving and emotion regulation (The research questions for this feasibility study are: (1) will the addition of the use of SwapMyMood result in at least equivalent clinically meaningful change in self-reported executive functioning and goal attainment compared to use of Executive Plus/STEP Program paper manuals alone in SM/Vs with mTBI and co-occurring psychological conditions?; (2) will SM/Vs with mTBI and co-occurring psychological conditions rate SwapMyMood usability as acceptable?; and (3) is the study design feasible for conducting this research within a clinical setting? The research protocol was embedded in a clinical program to provide insight on intervention implementation in a real-world healthcare setting. | PMC9915093 | |
2. Materials and Methods | The study protocol was approved for use of human subjects by the Shepherd Center Institutional Review Board. Clinicians were directly involved in the study design, administration, and data collection. Participants, intervention providers, and those assessing the outcomes were not blinded.Feasibility studies are usually conducted in preparation for a larger, main study [This feasibility study focuses on three core aims. The first aim, evaluating preliminary efficacy of the intervention, was addressed by measuring participant goal attainment, change in clinical measures of executive function, and change in self-assessment of knowledge of how to use the intervention. The outcomes of participants who received the SwapMyMood app were compared to outcomes of those who only received conventional care. The second aim, measuring acceptability of the SwapMyMood app by target users, was measured by using a standardized usability scale and gathering feedback from participants regarding their experience using the app. The third aim, assessing the study design for implementation in a target clinical setting, was achieved by evaluating the quality and completeness of data collected as well as the ease/difficulty of recruiting and retaining participants within the context of an outpatient program serving SM/Vs with mTBI and co-occurring psychological conditions. | PMC9915093 | ||
2.1. Intervention | SwapMyMood was developed following principles of user-centered design, engaging stakeholders at each stage of development as previously described [ | PMC9915093 | ||
2.2. Participants and Procedures | stroke, cognitive functioning, brain injury | STROKE | A total of 8 participants were recruited from the SHARE Military Initiative (SHARE) intensive outpatient program at Shepherd Center in Atlanta, Georgia. SHARE is a donor-funded program that provides comprehensive, intensive interdisciplinary outpatient rehabilitation care to military SM/Vs experiencing symptoms of brain injury and co-occurring psychological conditions in a civilian setting. Trained study staff approached each eligible SHARE client to inquire about participation in the current study. Prospective participants were assured that their decision to participate or not in the current study would have no bearing on their clinical care. Clients expressing interest were scheduled for a subsequent research visit, and informed consent was obtained. Participants were enrolled in the study and received care at different times based on when they were admitted to SHARE. Inclusion criteria:Diagnosis of mTBI at least 6 months post-onset;Identified by SHARE behavioral health (BH) provider or speech-language pathologist (SLP) as appropriate for Executive Plus/STEP interventions;18 years of age or older;Functional hearing and vision;Able to follow 2-step directions;English fluency;Functional reading;iOS or Android smartphone user; andSpeaks or types functionally for smartphone use.Exclusion criteria:Participation in SHARE for less than 6 weeks;Other conditions that may impact cognitive functioning (e.g., stroke, psychosis).Prior to study enrollment, all participants received instruction in use of the Executive Plus/STEP strategies from experienced SLP and BH providers in group therapy sessions as part of standard care. Continued training in the use of Executive Plus/STEP strategies was administered via weekly SLP group sessions and BH group sessions, each lasting 60 minutes. Homework assignments, individualized to the participant and determined through patient–provider collaboration, were given to support use outside of the clinical setting. Data on specifics and frequency of homework were not included in this study. Due to the COVID-19 pandemic, some participants received treatment via telehealth during portions of the program. Eligible participants who provided consent were block randomized to one of two groups. Conventional care group participants received ongoing Executive Plus/STEP strategy training using traditional paper manuals and protocols without the use of any mobile app, while experimental group participants received the same training and were provided version 1.0.4 of the SwapMyMood app, which was downloaded to their personal smartphone. In order to prevent cross-contamination between the conventional care group and the experimental group who were all receiving treatment in the same clinical setting, we block randomized such that 50% of all the participants were assigned to the conventional care group first. We then assigned the remaining 50% of participants to the experimental group. | PMC9915093 |
2.3. Measures | Participants completed assessments pre- and post-intervention. Pre-measures were recorded following a 2-week evaluation that was completed as part of the clinical program; post-measures were completed following a 6-week treatment period (Goal Attainment Scaling (GAS), an individualized outcome measure involving goal selection and scaling, and standardized to calculate level of goal attainment over the course of an intervention, was used as the primary outcome measure [Participants also completed pre–post standardized, self-report assessments of executive functioning. Overall executive functioning was measured via the Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) [ | PMC9915093 | ||
2.4. Data Analysis | PTSD | Participant characteristics, such as age, race, and gender, are presented at an individual-patient level. Outcomes are described using counts/percentages for categorical variables and means/standard deviations for scale variables. While under-powered, initial comparisons between groups were conducted using the χ2/exact test for categorical variables and Mann–Whitney U test for scale variables. In order to conduct adjusted comparisons, propensity scores were first computed using age, race, gender, type of sessions (e.g., hybrid, in person, etc.), hours of group treatment addressing the interventions, time since injury, education, diagnosis of PTSD, and score at admission. Due to the sample size, a ridge penalty was used to compute propensity scores. Comparisons were then repeated using the Cochran–Mantel–Haenszel test and Quade rank-order analysis of covariance for categorical and scale outcomes, respectively. Analyses were conducted using R (v4.2) [ | PMC9915093 | |
4. Discussion | TBI, brain injury | Results of this pilot feasibility study suggest SwapMyMood may be an acceptable addition to the use of paper manuals to support SM/Vs with mTBI and co-occurring psychological conditions in using the executive functioning strategies taught in the Executive Plus/STEP Program and should be studied in an adequately powered, randomized controlled trial. The groups were statistically comparable on all outcome measures, both with and without adjustments for group difference in demographic, injury, and treatment characteristics, and both groups demonstrated post-intervention gains in goal attainment, executive function, problem-solving, emotion regulation, and knowledge of how to use the strategies targeted. Furthermore, all participants in both groups demonstrated meaningful change in executive function as measured by GAS. The present study does not control for or consider the impact of other rehabilitation services and interventions participants received during the study period, and thus, gains in executive function cannot be interpreted as resultant of the study intervention. However, the equivalent gains demonstrated by the groups provide preliminary support for use of SwapMyMoood as an adjunct option to conventional care, adding evidence for the feasibility of use of computerized technology for cognitive and behavioral interventions for people with brain injury [These findings suggest feasibility by demonstrating effective implementation of the SwapMyMood app in a clinical setting in this sample. This intervention was implemented during the COVID-19 pandemic when in-person clinical interventions were not available for every client. This study suggests that SwapMyMood may be an acceptable intervention which can be utilized for remote use for people with brain injury who are unable to obtain in-person care (e.g., due to financial or transportation limitations or disruptions such those caused by the COVID-19 pandemic). Limited access to rehabilitation services after TBI for individuals in underserved groups is well documented in the literature [ | PMC9915093 | |
4.1. Limitations | The primary limitation of this study is the small sample size, which limits statistical analysis and the generalizability of findings. While both groups demonstrated post-intervention gains and appear statistically comparable, it is unknown whether differences may be detectable in a larger sample. While statistically non-significant, it is notable that the conventional care group received more hours of group instruction compared to the experimental group, who had more frequent absences and scheduling conflicts. It is unknown whether this negatively impacted experimental group outcomes. Additional training on the interventions during other treatment sessions at SHARE or elsewhere was not tracked nor was the completion of homework and frequency of use of the interventions outside of group sessions. Therefore, group differences and the potential impact of those differences is unknown. The impact of the psychological conditions (This study was conducted in a real-world clinical setting during the COVID-19 global pandemic, which required some participants to receive a hybrid program including interventions delivered via a telehealth platform in addition to in-person care. While half of the participants in each group received hybrid care, the exact number of in-person versus virtual group therapy sessions was not considered in the analysis. Furthermore, the efficacy of telehealth delivery of the Executive Plus/STEP protocol in comparison to in-person care has not been robustly studied, and therefore, the extent to which varied service delivery methods influenced outcomes is unknown. | PMC9915093 | ||
4.2. Future Directions | A central aim of this study was to assess whether SM/Vs with co-occurring psychological conditions would find SwapMyMood acceptable and useful. While most experimental group participants rated the app highly on the SUS, one participant did not. Participant feedback will be considered in refinements to the current version of the SwapMyMood app, which is aimed at improving usability and enhancing design features.These data will also be used to inform version 3.0 development, to incorporate machine learning and artificial intelligence to support context awareness and predictive modeling to anticipate user needs to utilize problem-solving and emotion regulation tools. These features and functions will enhance support for users by delivering timely prompts, reminders and engagement supports, while minimizing risk of over-communication with the user. Additional enhancements will offer opportunity for clinical providers outside of the research team to access user data in the admin portal to support remote monitoring, care provision, and independent research studies. Future research will be conducted in larger controlled trials with a more racially, ethnically, and demographically diverse cohort to ensure replicability of present results. | PMC9915093 | ||
5. Conclusions | SwapMyMood may be a clinically effective supplemental tool for supporting executive function in SM/Vs with mTBI and co-occurring psychological conditions and should be studied in a larger, controlled trial with a more diverse cohort, using methodology similar to that used in this feasibility study. | PMC9915093 | ||
Author Contributions | Conceptualization, T.W. and J.M; Methodology, R.G., J.M. and T.W.; Validation, R.G. and T.W.; Formal Analysis, R.G., J.M. and T.W.; Investigation, R.G.; Data Curation, R.G.; Writing—Original Draft Preparation, R.G. and T.W.; Writing—Review and Editing: T.W., J.M. and R.G.; Project Administration, T.W. and J.M.; Funding Acquisition, J.M. and T.W. All authors have approved the submitted version. All authors agree to be personally accountable for the author’s own contributions and for ensuring that questions related to the accuracy or integrity of any part of the work, even ones in which the author was not personally involved, are appropriately investigated, resolved, and documented in the literature. All authors have read and agreed to the published version of the manuscript. | PMC9915093 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board at Shepherd Center (project number 678, protocol version 3.1.21 approved on 3 March 2021). | PMC9915093 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9915093 | ||
Data Availability Statement | The raw data supporting the conclusions of this article will be made available by the authors without undue reservation. | PMC9915093 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results. | PMC9915093 | ||
KEYWORDS | PMC10269780 | |||
INTRODUCTION | Crohn’s disease, IBD, ulcerative colitis, UC | INTESTINAL INFLAMMATION, INFLAMMATORY BOWEL DISEASE, REMISSION, ULCERATIVE COLITIS | Inflammatory bowel disease (IBD), mainly defined as either ulcerative colitis (UC) or Crohn’s disease (CD), is a chronic and relapsing intestinal inflammation involving various factors and an abnormal immune response (For decades, fecal microbiota transplantation (FMT), the administration of a fecal suspension obtained from healthy donors into the gastrointestinal tract of a patient, has been used successfully for bacteriotherapy in individuals with Currently, multiple modes of FMT administration, including colonoscopy, nasoduodenal tubes, enemas, and capsules, are available to clinicians (Here, we investigated the longitudinal dynamics of serum metabolites and the gut microbiome of bacteria in UC patients after capsulized FMT treatment. We aimed to determine the efficiency of treatment of UC patients with capsulized FMT and determine the functional factors associated with clinical remission through multiomic analyses. | PMC10269780 |
RESULTS | PMC10269780 | |||
Beneficial outcomes of FMT. | gastrointestinal complaints, UC | ULCERATIVE COLITIS, ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, REMISSION, EVENTS | Between June 2016 and June 2019, 22 patients with active UC were recruited and assessed for eligibility. Enrolled patients received capsulized FMT treatment and completed the final follow-up at week 12. During the follow-up visits, one patient failed the screening process and was thus excluded. The clinical trial protocol is shown in Effect of fecal microbiota transplantation on 12-week remission in patients with ulcerative colitis. (A) Trial profile of fecal microbiota transplantation in patients with ulcerative colitis; (B) time points for obtaining fecal samples (triangles), clinical evaluation by Mayo scoring (diamonds), and colonoscopy (circles) during this clinical trial. Shown are changes in endoscopy and hematoxylin-eosin staining (C) and Mayo scores (D) for UC patients before and after treatment with FMT. The parallel line shows the change in Mayo score for individual patients, with a solid line indicative of values for FMT. Each line started at the baseline (W0 [circle]) and finished at its endpoint (W12 [triangle]). The achievement of clinical remission is indicated in green, and nonclinical remission is shown in red. Asterisks in in box plots represent the mean Mayo scores of each group. The significance was determined by paired Wilcoxon rank sum test. FMT, oral capsulized fecal microbiota transplantation.Baseline characteristics of patients with UC and the outcomes after treatment by FMTCRP, C-reactive protein; ESR, erythrocyte sedimentation rate; WBC count, white blood cell count.The efficacy analysis included 21 patients, excluding 1 patient who lost communication during the study.Over the 12-week study, a significant reduction in the total Mayo score was observed compared to the baseline. The patients who achieved a Mayo score with a ≥3-point reduction and a reduction of ≥30% at week 12 were considered responders (Rps). The patients who achieved a Mayo score of ≤2 at week 12 were considered to be in clinical remission (Rm). At the baseline, there were no significant differences in the total Mayo score between responders (Rps) and nonresponders (NRps) or patients in the remission (Rm) and nonremission (NRm) stages. The mean total Mayo score significantly (Satisfactorily, no serious adverse events occurred during the study period, and capsulized FMT treatment was well tolerated. The most frequently occurring adverse events were gastrointestinal complaints, including increased bowel movements (Adverse events during the 12-week studyAE, adverse event; SAEs, serious adverse events.Data are number of events or number of patients with percentage shown in parentheses.Laboratory tests of UC patients during FMT treatmentRm group, patients in clinical remission; NRm group, patients in the nonremission stage; W1, W4, and W12, weeks 1, 4, and 12, respectively; CRP, C-reactive protein; ESR, erythrocyte sedimentation rate; WBC count, white blood cell count. | PMC10269780 |
Alterations in gut microbiota after FMT. | UC | Bacterial α diversity was assessed by determining richness (observed and Chao1), Shannon diversity, and Pielou’s evenness based on 16S V3-V4 sequencing. As expected, the bacterial α diversity, observed richness (Similarly, both richness indices were significantly higher in donor samples than in baseline samples of patients. The bacterial richness of samples from UC patients increased significantly after capsulized FMT and was comparable to that of samples obtained from donors at week 1 but was reduced at weeks 4 and 12 (Alterations in gut bacterial communities of UC patients after FMT. (A) Estimating the α diversity by the richness (observed OTUs and Chao1) and Shannon and Pielou’s evenness. The dashed line indicates significant ( | PMC10269780 | |
Enrichment of beneficial bacteria associated with the clinical remission after FMT accompanied the decrease in levels of opportunistic pathogens. | UC | REMISSION | UC patients who achieved clinical remission exhibited efficient and durable changes in their gut microbiota after FMT. Based on 16S V3-V4 sequencing, gut bacterial richness was increased in the clinical remission (Rm) group and was comparable to that of donors during the follow-up visits after FMT. In contrast, the richness indices at week 4 and week 12 after FMT were significantly (Changes in gut bacterial communities associated with Rm and NRm after FMT. (A) α diversity of Rm, NRm, and donor samples, estimated by richness (observed OTUs) and Shannon and Pielou’s evenness. The dashed line indicated significant (To identify the taxa associated with clinical remission, the differences in genera in the Rm or NRm groups were evaluated between each time point after FMT, and the baseline values were analyzed by the paired rank sum test. | PMC10269780 |
Shotgun metagenomic analyses confirmed the signatures associated with clinical remission. | REMISSION | To further reveal the gut microbial signatures associated with clinical remission, the microbial data obtained after shotgun metagenomic analyses of week 0 Rm (W0_Rm) and W4_Rm and week 0 NRm (W0_NRm) and W4_NRm were analyzed using the paired Wilcoxon test. A total of 5,466 species were annotated using kraken2, of which the relative abundance of 937 species was significantly changed, specifically between W0_Rm and W4_Rm (Table S2). Among the top 20 species exhibiting a shift in abundance levels, the increased relative abundance of Microbial signatures are specifically associated with clinical remission at week 4. Shown are (A) species, (B) KEGG modules, and (C) MetaCyc pathways whose abundance significantly decreased or increased uniquely in W4_Rm compared to the W0_Rm group (namely, not significantly differentiated in W4_NRm versus W0_NRm) during the shotgun metagenomic profiling of fecal samples. The significance was tested using the paired Wilcoxon test. The top 20 signatures of each category indicative of the relative abundance were visualized. Asterisks indicate the mean values of each signature.Metabolic profiles are associated with clinical remission at the baseline and time points after FMT. (A) PLS_DA of metabolomic profiles in the positive-ion model with regard to time points (left panel) and Euclidean distances of samples within the same time points (right panel). Data were subjected to a Hellinger transformation. Letters indicate groupings with significant differences. (B) Metabolites whose relative abundances were significantly different between the baseline and samples after FMT were filtered by variable importance if the variable importance projection (VIP) score was >1 and were structurally identified in databases. (C) PLS_DA of metabolomic profiles in the positive-ion model at weeks 0 and 4 after FMT after achieving clinical remission or not achieving clinical remission (left panel), as well as Euclidean distances of patients between week 0 and week 4 (right panel). Data were subjected to a Hellinger transformation. (D) Metabolites whose levels were significantly decreased or increased uniquely in W4_Rm, compared with the W0_Rm group (namely, not significantly differentiated in W4_NRm versus W0_NRm), were filtered using a VIP score of >1 and structurally identified in databases. (E) Relative abundance of partial metabolites that changed over time after FMT and were further stratified by clinical remission. | PMC10269780 | |
Metabolomic profiling of UC patients achieving remission. | metabolic alterations | REMISSION | Global metabolomic analysis of serum samples revealed metabolic alterations and metabolites associated with clinical remission after capsulized FMT administration. As visualized in the partial least-squares discriminant analysis (PLS_DA) ordination, the metabolomic profiles of patients were shifted after FMT treatment in both positive- and negative-ion models ( | PMC10269780 |
Interomic correlations between gut microbes and metabolites. | Procrustes analysis demonstrated the strong cooperative relationships between the gut microbiota and KEGG modules (MInteromic correlations between gut microbes and metabolites. (A) Procrustes analysis of gut microbial species and serum metabolites; (B) proportion of the total variations in serum metabolomes for different gut microbial species; (C) Pearson correlation-based network analysis of the top 20 gut microbial species, MetaCyc pathways, KEGG modules, and serum metabolites that were uniquely significantly different between W0_Rm and W4_Rm. Species with significant correlations ( | PMC10269780 | ||
DISCUSSION | ulcerative colitis, UC | DISEASE, REMISSION, ULCERATIVE COLITIS | In this study, we explored the clinical outcomes of capsulized FMT treatment in patients with active UC. We also performed a general analysis of the gut microbiota and serum metabolites to identify specific taxonomic, functional, and metabolite changes associated with clinical outcomes after FMT. Capsulized FMT could induce clinical remission in 57.1% (12 of 21) of patients with UC and clinical response in 76.2% (16 of 21) of patients at week 12. The gut microbiome and serum metabolites in samples obtained from patients were significantly altered after capsulized FMT treatment, especially at week 4. Improvements in microbial richness, depletion of opportunistic pathogens (The key features distinguishing this study from previous studies on FMT in UC patients were the low intensity of microbiota transplantation using capsules and the high efficiency of clinical remission. Previously, colonic transendoscopic tubes or enemas were the main methods used to deliver fecal microbiota transplantation, and the treatment cycle was relatively long. For example, Paramsothy et al. first achieved a single colonoscopic delivery of FMT to the right colon and then performed enemas 5 days per week for 8 weeks (Generally, if clinical symptoms were relieved 4 weeks after FMT, most patients could be in a stationary phase. The longer the time required for symptom remission, the worse the prognosis. We attempted to reveal the relationship between lesion regions (E1, E2, and E3) or disease severity and the clinical response, but there were no significant differences in the efficacy of capsulized FMT, indicating that the impact of capsulized FMT was unrelated to the lesion area and disease severity. We also observed remarkable and specific differences in gut microbiota and metabolites between the Rm and NRm groups at week 4 after FMT. Notably, previous studies also investigated changes in the microbiota at 4 weeks after FMT, and results show consistent trends (We also observed that microbial richness was significantly decreased in patients with UC compared to that in healthy individuals. However, microbial richness levels were improved to levels comparable to those of donors only in patients who achieved clinical remission at week 12 after FMT. Improvement of gut microbial richness after FMT has been reported in previous clinical studies on UC patients (Microbes and functional microbial pathways associated with clinical remission were further analyzed based on 16S rRNA gene and metagenomic data sets. Compared with the baseline, the increased relative abundance of species, including Serum metabolite profiles were significantly different between the baseline and week 4 after FMT. Among these profiles, elevated levels of indolelactic acid, PGH2-EA, and isohyodeoxycholic acid were associated with a favorable treatment output, while increased levels of 12,13-DiHOME were associated with worse outcomes. PGH2-EA, a prostaglandin, showed anti-inflammatory properties in ulcerative colitis (In general, we demonstrated the efficacy of FMT in patients with mild to severe UC through well-prepared donor stool capsules administered orally three times a week. Capsulized FMT could accelerate the metabolism of tryptophan by increasing the abundance of | PMC10269780 |
MATERIALS AND METHODS | PMC10269780 | |||
Study design. | UC | We conducted a single-arm pilot clinical trial by enrolling 22 patients with active UC between June 2016 and June 2019 at Zhongshan Hospital in Xiamen University. Nine donors were included in the study, and their stool was extracted and filled into capsules. To increase microbial diversity, every patient randomly received FMT infusions from two or three donors. Patients underwent three capsulized FMT procedures (one every 2 days) within a week. After 12 weeks of follow-up visits, clinicians assessed the effect of FMT on UC patients. Maintenance therapy involved the administration of a stable dose (prior to enrollment) of 5-ASA/SASP (salicylazosulfapyridine) and prednisone that was mandatorily tapered to 5 mg (>10 mg/day) or 2.5 mg (≤10 mg/day) per week. Stool samples of patients with UC were collected at weeks 0, 1, 4, and 12 for microbiome analysis, and blood samples were collected for laboratory examination and metabolomic analysis. This study was approved by the Zhongshan Hospital of Xiamen University and was registered at ClinicalTrials.gov (registration no. NCT03426683). | PMC10269780 | |
Withdrawal criteria. | Patients could withdraw from the study at any time. To ensure the reliability of data, patients were informed that they needed to contact clinicians before withdrawal and provide reasons for leaving. | PMC10269780 |
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