Patients In Intervention Group Research Articles

Effectiveness and cost-effectiveness of mechanical diagnosis & treatment combined with transforaminal epidural steroid injections for patients on a waiting list for surgery for a chronic lumbar herniated disc: A randomized controlled trial and economic evaluation.

Mechanical Diagnosis and Treatment (MDT) and epidural steroid injections have the potential to reduce pain and disability in sciatica patients and prevent surgery. However, data on their combined influence in reducing the amount of sciatica surgeries is lacking. To assess if a combination therapy (MDT and TESIs), administered while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared to no intervention (i.e., usual care). Multicentre randomized controlled trial with economic evaluation and one-year follow-up. Seventy-two adult patients on a waiting list for lumbar herniated disc surgery. Primary outcome was undergoing lumbar disc surgery during follow-up (yes/no). Secondary outcomes included back and leg pain intensity (NPRS), physical functioning (RMDQ-23), self-perceived recovery (GPE), and health-related quality of life (EQ-5D-5L). Total societal and total healthcare were measured. Participants were randomly assigned to combination therapy (intervention group, n=34) or no intervention (control group, n=38). Twenty-nine out of 38 control group patients and 11 out of 34 intervention group patients received surgery. The adjusted odds ratio of receiving surgery in the intervention group compared to the control group was 0.09 (95%CI: 0.02 to 0.35) and the adjusted risk ratio 0.29 (95%CI: 0.08 to 0.69). There were no differences in clinical effects between both groups. Surgical, total societal, and total healthcare costs were on average €1,969, €1,754, and €2,363 lower in the intervention group, respectively. The combination therapy's probability of being cost-effective was moderate (≤0.66) across a range of willingness-to-pay values from €20,000/QALY to €80,000/QALY, from a societal perspective. Patients on the waiting list for lumbar disc surgery and who are open to postpone surgery, may benefit from the combination therapy intervention.

Effect of invasive acupuncture on awakening quality after general anesthesia: systematic review and meta-analysis.

The process of waking up from general anesthesia is still not well understood, and recovery issues such as delayed awakening, agitation, postoperative cognitive dysfunction, continue to be a challenge for anesthesiologists. Currently, the treatment of these complications is mainly achieved through the antagonistic action of specific drugs, but sometimes the antagonistic drugs are not as effective as they should be and can add to the financial burden of the patient. Acupuncture, a common treatment in Traditional Chinese Medicine, is widely used around surgery. However, there is no enough evidence to show it improves recovery after anesthesia. To explore this, we reviewed relevant randomized trials and conducted a meta-analysis. This systematic review was conducted to explore the effect of perioperative application of invasive acupuncture on the quality of postoperative awakening after general anesthesia. By searching PubMed, Embase, Cochrane Clinical Trials Center, China Knowledge Network (CNKI), China Biomedical Database (CBM), Wanfang Medical Database, Weipu Database, to include randomized controlled trials of invasive acupuncture applied perioperatively. Search is limited from the build-up of the database to March 2022. The statistical analysis was conducted using RevMan 5.3. Quality assessment of the included research literature using Cochrane-recommended risk of bias assessment tool. 18 randomized controlled trials were included with 1,127 patients. 565 patients in invasive acupuncture intervention group, 562 patients in control group. Results showed that invasive acupuncture group had a shorter eye opening time than control group (MD = -6.42, 95% CI [-8.17, -4.66], p < 0.001), shorter extubation times (MD = -5.84, 95% CI [-8.12, -3.56], p < 0.001), lower MAP at extubation (MD = -18.54, 95% CI [-22.69, -14.39], p < 0.001), lower HR at extubation (MD = -14.85, 95% CI [-23.90, -5.81], p < 0.001). No statistical difference in the occurrence of POCD (OR = 0.56, 95% CI [0.28, 1.11], p = 0.10) and postoperative agitation (OR = 0.42, 95% CI [0.11, 1.65], p = 0.21). https://www.crd.york.ac.uk/PROSPERO/, CRD42023410260.

Computerized cognitive rehabilitation in patients with multiple sclerosis (MS): A systematic review and meta-analysis.

Cognitive impairment (CI) is one of the main features of multiple sclerosis (MS). Cognitive rehabilitation (CR) programs are crucial for improving cognition and computer-assisted cognitive rehabilitation is considered as an effective method for cognition rehabilitation. To assess the effects of computer-based cognitive rehabilitation program on cognition in patients with multiple sclerosis (MS). We performed a comprehensive search in PubMed, Scopus, Web of Science, EMBASE, and Google Scholar databases along with gray literature up to September 2021. Randomized clinical trials, articles had been published in the English language. We evaluated the risk of potential bias via the Cochrane Collaboration's tool for assessing the risk of bias. Standardized mean difference (SMD) was calculated. The preliminary search retrieved 2302 articles by literature search, after deleting duplicates 2248 remained. Eight articles remained for meta-analysis. Totally, 235 patients in intervention group and 192 in control group were evaluated. Mean age ranged from 43.5-52 years. The SMD of PASAT (Paced Auditory Serial Addition Test) (Case-control) test was 0.35 (95%CI:0.1-0.66) (I2:24.4%, P=0.2). The SMD of SDMT (Case-control) test was 0.07 (95%CI:-0.18-0.33). The SMD of PASAT before and after intervention in case group was 0.68 (95%CI:0.45-0.91) (I2:40%, P=0.15). The SMD of SDMT before and after intervention in case group was 0.44 (95%CI:0.21-0.66) (I2:40%, P=0.15). The results of this systematic and meta-analysis showed that computerized cognitive rehabilitation program is effective in improving PASAT score.

Effects of antioxidant nutrients on muscle mass, strength and function in COPD patients: A meta-analysis of randomized controlled trials.

To comprehensively investigate the effects of antioxidant nutrients on muscle mass, strength and function in chronic obstructive pulmonary disease (COPD) patients. PubMed, Embase, Cochrane Library, and Web of Science were comprehensively searched from the inception to January 3, 2024. The quality of randomized controlled trials (RCTs) was measured using the Jadad scale. Weighted mean differences (WMDs) and 95% confidence intervals (CIs) were used as the effect size for measurement data. Further, subgroup analysis was conducted based on whether patients participated in lung rehabilitation plans while receiving nutritional interventions. Sensitivity analysis was performed on all outcomes. A total of 12 studies involving 595 patients with COPD were included, with 11 studies had high quality, and one study had low quality. For muscle mass, patients receiving antioxidant nutrients had a significantly increased lean body mass index compared with those not receiving antioxidant nutrients (pooled WMD: 0.903, 95% CI: 0.264, 1.541, P = 0.006). For patients who did not participate in lung rehabilitation plan while receiving nutritional interventions, antioxidant nutrients brought about a significantly higher lean body mass index (pooled WMD: 1.360, 95% CI: 0.560, 2.160, P = 0.001). For muscle strength, patients in the antioxidant nutrient intervention group had significantly higher hand grip strength (HGS) than those in the non-antioxidant nutrient intervention group (pooled WMD: 1.976, 95% CI: 1.337, 2.615, P < 0.001). Patients receiving antioxidant nutrients had significantly greater inspiratory muscle strength (MIP) than those not receiving antioxidant nutrients (pooled WMD: 8.127, 95% CI: 2.677, 13.577, P = 0.003). Antioxidant nutrient intervention significantly improved HGS, MIP and lean body mass index in COPD. Clinicians should consider increasing food intake or supplementation rich in antioxidants in the treatment plan of patients with COPD.

The Effect of Expressive Writing on the Experiences of Head and Neck Cancer Patients Undergoing Radiotherapy: A Randomized Controlled Trial.

Expressive writing (EW) has emerged as an innovative strategy for improving mood and quality of life. Nevertheless, insufficient research has been conducted on the impact of offering EW to patients with HNC. Therefore, the purpose of this study was to investigate the effects of two forms of EW on anxiety, depression, nutrition, and sleep quality in HNC patients undergoing radiotherapy. We conducted a single-blind, pretest, posttest, three-group randomized controlled trial. A total of 147 patients with HNC were randomly assigned to a benefit-finding writing group, neutral writing group, or control group. The intervention group patients performed EW during radiotherapy, with each writing session lasting 20 min, once a week for 4 consecutive weeks. Patient anxiety, depression, nutritional status, and sleep quality were measured at baseline (T0) and at the end of radiotherapy (T1). After 4 weeks of intervention, patients in the BF and NW groups experienced improvements in anxiety, depression, and sleep (p < 0.05) compared with those in the CG group, but the intervention did not significantly affect patients' nutritional status (p > 0.05). Compared with those in the CG, anxiety in the BF and NW groups slowed down the trend of increasing anxiety, and repeated measures analysis revealed a significant group × time interaction (p = 0.017, F = 4.205, η2 = 0.059). Compared with those in the CG, the depression levels in the BF and NW groups were lower than those at baseline, and repeated measurement analysis revealed that the interaction effect between group × time was significant (p = 0.000, F = 16.262, η2 = 0.194). The sleep quality in the CG progressively worsened from T0 to T1 (p < 0.01), whereas in the BF, it progressively improved (p < 0.01). This study provides preliminary evidence that two forms of EW are effective in alleviating anxiety and depression and improving sleep in patients with HNC but are not effective in improving their nutritional status. ChiCTR2400084964.

Swab Testing to Optimize Pneumonia treatment with empiric Vancomycin (STOP-Vanc): study protocol for a randomized controlled trial

BackgroundVancomycin, an antibiotic with activity against methicillin-resistant Staphylococcus aureus (MRSA), is frequently included in empiric treatment for community-acquired pneumonia (CAP) despite the fact that MRSA is rarely implicated in CAP. Conducting polymerase chain reaction (PCR) testing on nasal swabs to identify the presence of MRSA colonization has been proposed as an antimicrobial stewardship intervention to reduce the use of vancomycin. Observational studies have shown reductions in vancomycin use after implementation of MRSA colonization testing, and this approach has been adopted by CAP guidelines. However, the ability of this intervention to safely reduce vancomycin use has yet to be tested in a randomized controlled trial.MethodsSTOP-Vanc is a pragmatic, prospective, single center, non-blinded randomized trial. The objective of this study is to test whether the use of MRSA PCR testing can safely reduce inappropriate vancomycin use in an intensive care setting. Adult patients with suspicion for CAP who are receiving vancomycin and admitted to the Medical Intensive Care Unit at Vanderbilt University Medical Center will be screened for eligibility. Eligible patients will be enrolled and randomized in a 1:1 ratio to either receive MRSA nasal swab PCR testing in addition to usual care (intervention group), or usual care alone (control group). PCR testing results will be transmitted through the electronic health record to the treating clinicians. Primary providers of intervention group patients with negative swab results will also receive a page providing clinical guidance recommending discontinuation of vancomycin. The primary outcome will be vancomycin-free hours alive, defined as the expected number of hours alive and free of the use of vancomycin within the first 7 days following trial enrollment estimated using a proportional odds ratio model. Secondary outcomes include 30-day all-cause mortality and time alive off vancomycin.DiscussionSTOP-Vanc will provide the first randomized controlled trial data regarding the use of MRSA nasal swab PCR testing to guide antibiotic de-escalation. This study will provide important information regarding the effect of MRSA PCR testing and antimicrobial stewardship guidance on clinical outcomes in an intensive care unit setting.Trial registrationClinicalTrials.gov NCT06272994. Registered on February 22, 2024.

The Impact of Telenursing on the Self-management of Gastrointestinal Symptoms in Adolescent Cancer Patients Receiving Chemotherapy.

Chemotherapy is one of the cancer treatments among adolescents, after which nursing care at home is required due to developing side effects such as constipation, nausea, vomiting, and diarrhea. One solution to deliver nursing care is to provide remote self-management training. The aim of this study is to investigate the impact of telenursing on the self-management of gastrointestinal (GI) symptoms among adolescents undergoing chemotherapy. In this intervention study, 66 adolescents 12 to 18 years of age who were referred to teaching hospitals for receiving chemotherapy were selected through randomized block sampling. The data were collected through demographic and clinical questionnaires, the researcher-made form for GI symptoms and conditions, and the researcher-made questionnaire for the self-management of GI symptoms among adolescents. Data analysis was done using SPSS version 20. The findings show that there was no significant statistical difference between the control group and the intervention group in terms of demographic characteristics. According to the independent-samples t test and repeated-measures analysis of variance, using an educational website had a significant positive impact on the scores of GI symptoms self-management, 1 week and 1 month after the intervention (P < .001). Given that the intervention group patients could better manage their GI symptoms on their own by visiting the educational website Cancer Information, it can be concluded that telenursing can affect the self-management of GI symptoms among adolescent patients with cancer who receive chemotherapy. The website Cancerinformation.ir can be used in the self-management of GI symptoms in cancer patients.

Curricular Self-management for patients on ventricular assist device support decreases depression: A multicenter randomized controlled trial.

Utilization of ventricular assist device (VAD) support in patients with end-stage heart failure is well advanced. Recent studies emphasize the need to develop and evaluate evidence-based psychosocial support interventions for patients following VAD implantation. A national, multi-center study in four established German heart centers was initiated. An evidence-based VAD curriculum was developed; a randomized controlled trial evaluated the impact of the interprofessional intervention over time. Primary combined endpoint was the occurrence of adverse events (thromboembolic events, driveline infections, bleeding, rehospitalization, and death); secondary endpoints were psychosocial outcomes (anxiety, depression [HADS], quality of life [QoLVAD], social support [FSoZu], and self-management [SELMA]). A total of 140 patients were randomized block-wise to intervention (IG n = 70) or control (CG n = 70). Center-effects were considered. Instruments were completed at four time points (T0-T3). At baseline, intervention group (IG) patients were 19% female (control group [CG] 19%; p = 0.982); 58 ± 11 years. (CG 58 ± 11 years.; p = 0.966); 80% were implanted electively (CG 79%; p = 0.968). No significant difference in primary endpoint was found between IG versus CG (p > 0.05). For secondary endpoints, mixed linear regression revealed a significant reduction in depression scores in IG compared to CG (est. 1.18; 95% CI -2.17 to -0.18; p = 0.021). Clinically significant reductions in anxiety were greater in IG patients between T0 and T3 (IG 51.9%; CG 40.7%); increased anxiety was reported in 3.7% IG (11.1% CG). Mixed linear regression analyses favored IG (all >0.05) for QoL, social support, and self-management. A comprehensive curricular VAD intervention has potential to decrease depression levels and improve psychosocial outcomes of patients on VAD support.

Patient With Chronic Heart Failure as a Participant in the Treatment Process: the Role of Structured Training And Outpatient Observation (on the Anniversary of the Study Chance).

Aim The article presents the principal results and conclusions of the study "SCHool and outpAtient moNitoring of patients with Cardiac failurE (CHANCE)", organized by the Society of Experts in Heart Failure.Material and methods CHANCE was a multicenter randomized study. Patients in the intervention group (IG) received the Structured Education and Flexible Outpatient Control Model, that included telephone contacts plus an additional visit if necessary. The planned visits for the IG and control group (CG) were scheduled at 3, 6, and 12 months. 360 IG patients and 385 CG patients were included in the analysis. In the main analysis of the CHANCE study, the efficacy was assessed by the impact on the hard endpoints (mortality and rehospitalizations), clinical condition, functional capabilities, quality of life, anxiety and depressive symptoms, and cost-effectiveness. Also, a comprehensive assessment was performed of the prevalence, structure, and dynamics of anxiety and depressive symptoms depending on the changes in the clinical condition.Results Mortality significantly differed between the groups: 30 (8.3%) patients died in the IG and 50 (13.0%) in the CG. The relative risk of death was 0.68, 95% confidence interval 0.42-0.99, p = 0.044. To prevent one death, it was necessary to educate and monitor 21 patients with clinically evident chronic heart failure (CHF) according to the principles of the CHANCE program. According to the dynamics of the Clinical Condition Assessment Scale (SCAS), the score difference between the groups was 1.7 (p&lt;0.001) after 12 months of follow-up in favor of the IG group. In 12 months, the increase in the 6-minute walk test distance was 98.7 m in the IG and 42.9 m in the CG (p&lt;0.001). The change from baseline in the Minnesota questionnaire total score was 15.3 ± 16.3 in the IG (p&lt;0.001) and 6.2 ± 15.3 in the CG (p&lt;0.001). The odds of developing depressive symptoms increased with each SCAS point by 19% (p = 0.0002). The odds of developing anxiety symptoms increased with each SCAS point by 12% (p = 0.02). The odds of developing the most unfavorable combination of anxiety and depressive symptoms increased with each SCAS point by 41% (p = 0.000002). The participation of patients in the study increased the odds of reducing the anxiety and depressive symptoms in patients with CHF by 2.35 times (p&lt;0.0001), to a greater extent in women.Conclusion The CHANCE study that included 42 centers in 23 cities of Russia became the forerunner of the first initiatives in organizing the outpatient follow-up of patients in real clinical practice and serves as a vivid example of the importance of national research programs. Their implementation allows obtaining results that can be scaled up throughout the country to make an important contribution to the improvement of medical care for patients with CHF.

Effectiveness of Virtual Reality Glasses on Surgical Fear and Anxiety in Patients Before Open-heart Surgery: A Double-blind Randomized Controlled Trial

PurposeFear and anxiety in open-heart surgery patients can adversely affect their physiological well-being and recovery. Although virtual reality glasses (VR-G) have been advanced for preoperative anxiety management, their effectiveness specifically for open-heart surgery patients remains under-researched. This study aims to evaluate the efficacy of watching a video through VR-G on surgical fear and anxiety levels of patients undergoing open-heart surgery. DesignA randomized controlled and double-blind study. MethodsIn total, 90 patients were randomly assigned to the VR-G intervention group or control group. On the surgery morning, intervention group patients watched a 360-degree video with nature sounds through VR-G before being transferred to the operating theater. The surgical fear and anxiety levels of the patients were evaluated at three stages using the Surgical Fear Questionnaire and Visual Analog Scale-Anxiety: initial evaluation in the morning, second evaluation before being transferred, and third evaluation in the waiting room of the operating theater. FindingsThe surgical fear level of the intervention group at the third evaluation was significantly lower than the control group (P < .000). There was no significant difference between the anxiety levels of the study groups (P > .05). ConclusionsWatching a 360-degree video with nature sounds through VR-G is an effective intervention in reducing surgical fear levels of patients before undergoing open-heart surgery. Use of VR-G interventions may be a practical and fast-resulting nursing strategy to manage patients’ surgical fear in the preoperative period. RegistrationNCT06165861

Readmission Rate and Percentage of Drug used as Guideline-Directed Medical Therapy Before and After Checklist (QR Code) Implement in Heart Failure Treatment

Background: Congestive heart failure (CHF) is a common cardiac syndrome that produces high morbidity, mortality, and rehospitalization. Nowadays, heart failure reduced ejection fraction (HFrEF) treatment as guideline directed medical therapy (GDMT) following by Thai Heart Failure Guideline 2019 has proven benefits. The authors recognized that many patients were readmitted because of improper medications. Implementing checklist before discharge might improve drug adherence and decrease hospitalization rate. Objective: Compared rehospitalization rate of CHF among patients using checklist and non-using checklist, as the primary outcome. Drug use as GDMT were also evaluated among both groups, as the secondary outcome. Materials and Methods: The present study used a retrospective cohort and compared HFrEF patients who used checklist, as intervention group, with non-using checklist, as control group. Intervention group patients were admitted between December 2020 and December 2021, whereas control group patients were admitted between December 2019 and November 2020 in Vajira Hospital. The medical records of the intervention and control groups were retrospectively reviewed at the first admission. The rehospitalization rate at one and three months were compared. The prescribed medications including angiotensin-converting enzyme inhibitor (ACEI)/angiotensin receptor blocker (ARB)/angiotensin receptorneprilysin inhibitor (ARNI), beta-blockers, spironolactone, and diuretics, as GDMT, before discharge were compared between groups. Results: One hundred forty-six patients were included, 56 patients in the checklist group and 90 patients in the control group. Prescription of beta-blockers was significantly higher in the checklist group compared to control group at 96.4% versus 83.3% (p=0.016). However, ACEI/ARB/ARNI prescribed was significantly lower in checklist group at 62.5% versus 84.4% (p=0.003). Spironolactone and diuretics used was not different between the groups. The 3-month readmission rate due to CHF was significantly lower in checklist group at 17.3 persons-3-months versus 37.9 persons-3-months (p=0.035). Conclusion: The checklist, or using QR code, implementation before discharge in HFrEF patients decreased the rate of rehospitalization at three months for CHF. Checklist using increased adherence to beta-blockers but decreased prescription of ACEI/ARB/ARNI drugs.

Evaluation of the effectiveness of medroxyprogesterone on blood gases and short-term hospital outcomes in patients with chronic obstructive pulmonary disease treating with noninvasive ventilation: A randomized clinical trial

Background: In the present study, we aimed to evaluate the effects of medroxyprogesterone on hospital short clinical outcomes and ABG parameters in patients with chronic obstructive pulmonary disease (COPD) exacerbation under treatments with noninvasive ventilation (NIV) treated with progesterone 15 mg in comparison with placebo. Materials and Methods: This is a double-blinded clinical trial that was performed in 2020–2021 in Isfahan, Iran, on 60 patients with COPD exacerbation that require NIV. All patients received short-acting beta-agonists, short-acting anticholinergics, systemic corticosteroids, and NIV. Patients in the intervention group received tablets of progesterone 15 mg, every 6 h for 5 days and the control group received a placebo; patients in both groups received routine clinical cares. We collected data regarding the days requiring NIV, hospitalization duration, intubation, intensive care unit (ICU) admission, and death. Furthermore, blood pH, PCO2, O2 saturation, dyspnea score, and NIV hours usage per day were evaluated at the time of admission, 3 and 5 days during admission. Results: Hospital short clinical outcomes were not differently distributed between the two groups (P &gt; 0.05). Comparing two groups during hospitalization in terms of short clinical outcomes including duration hospitalization, using NIV per day, ICU admission rate, and need to intubation showed that they are comparable (P &gt; 0.05). PH in both groups improved during follow-up (P &lt; 0.001) and patients in intervention groups showed higher improvement (P = 0.006). Mean PCO2 decreased significantly in the intervention group (P &lt; 0.001) but not in the control group (P = 0.198) and totally intervention showed significant improvement in PCO2 compared with the control group (P = 0.047). Although mean O2 saturation was increased in both groups during follow-up period (P &lt; 0.001, for both groups), two groups showed comparable (P = 0.910). Mean NIV using (hours/day) was decreased significantly in the intervention group (P = 0.023); however, it was not significantly higher than that was seen in the control group (P = 0.706). The mean dyspnea score was decreased in both groups (P &lt; 0.001), although a greater decrease was seen in the intervention group (P &lt; 0.001). Conclusion: Administration of medroxyprogesterone in patients with COPD exacerbation that required NIV was associated with significant improvements in blood pH, PCO2, dyspnea, and daily duration of NIV using after 3 and 5 days following hospitalization.

Effect of Music on Anxiety and Fatigue in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial.

Anxiety and fatigue are symptoms typically experienced by cancer patients undergoing chemotherapy. In dealing with these symptoms, listening to music may help patients. The randomized controlled study was conducted between May 1, 2022 and November 10, 2022 with 60 patients treated in the outpatient chemotherapy unit. The data were gathered using a patient information form, Brief Fatigue Inventory, and the State Trait Anxiety Inventory. In addition to standard treatment and care, 30-minute music was played with a passive listening method in a total of three cycles of chemotherapy in the intervention group patients who completed the first cycle and visited for the second cycle of chemotherapy. According to the analysis of covariance (ANCOVA) findings, the group variable significantly affected the post-test state anxiety scores when an adjustment was made for pre-test state anxiety scores (F=240.398, P<0.001, η²=0.808). In addition, pre-test state anxiety scores affected post-test results (F=7.925, P=0.007, η²=0.122). According to the ANCOVA findings, the group variable significantly affected the post-test trait anxiety scores (F=235.243, P<0.001, η²=0.805). In addition, pre-test trait anxiety scores affected post-test results (F=34.977, P<0.001, η²=0.380). According to ANCOVA results, the group variable significantly affected post-test fatigue scores (F=79.201, P<0.001, η²=0.582). In addition, pre-test scores affected post-test scores (F=11.082, P=0.002, η²=0.163). We observed that music had positive effects on fatigue and anxiety levels in cancer patients undergoing chemotherapy. It may be recommended to include music intervention in nursing practices for cancer patients during chemotherapy. The study results demonstrated that music intervention can be used in nursing practices for cancer patients during chemotherapy. Its low-cost and non-invasive nature also provide ease of application. Therefore, we can recommend the application of music intervention in outpatient chemotherapy units.

The Thoughtful program: a randomized controlled study of a mentalization-based mental health education intervention in a psychiatric outpatient population

Background P-factor and mentalizing theory and research set perspectives for transdiagnostic psychiatric treatments. Aims To test the effects of a low-cost mentalization-based health education program (the Thoughtful program) in an unselected waiting list population, from a psychiatric outpatient clinic in North Norway. Methods Waiting list patients were randomized (1:1 allocation): 79 patients in the control group were offered standard individual assessment and treatment. Seventy-nine patients in the intervention group were offered a one-day (six-hour) group-based Thoughtful course, plus individual assessment, and treatment. Results During a 6-month follow-up period, the number of patients in active assessment and treatment was 66% higher in the control group than in the intervention group. Self-reported patient questionnaire scores on mentalizing, well-being and suicidal ideation scores showed no significant changes in the control group. In the intervention group, significant changes were reported: Mentalizing scores improved by 72% and well-being scores improved by 55%. Suicidal ideation scores were not significantly changed. No adverse effects were registered. Limitations The results from this study should be interpreted with caution because of a small population size and low questionnaire response rate. The follow up period was limited to 6 months. Transfer of program information from intervention group patients to control group patients could not be guaranteed. It may be considered a limitation that diagnostic pattern analysis was not included in the study. Conclusions A low-cost transdiagnostic mentalization-based educational program in an outpatient psychiatry clinic may improve patient mentalizing and wellbeing without adverse effects and reduce the use of hospital services.

Effect of empagliflozin on no-reflow in patients with st elevation myocardial infarction undergoing primary percutaneous coronary intervention

Abstract Background Primary percutaneous coronary intervention (PPCI) restores myocardial tissue perfusion successfully in over 90 % of ST-elevation myocardial infarction (STEMI) patients .However there remains a small proportion of patients who exhibit no-reflow.(1) Empagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor that acts as a powerful anti-oxidant and has beneficial effects on endothelial function and reducing burden of ischemia in-vitro.(2) Aim and Objectives: To Assess the effect of Empagliflozin preloading in non-diabetic STEMI patients before PPCI on procedural, in-hospital outcomes and short-term Major Adverse Cardiovascular events (MACE) in a single tertiary center. Patients and Methods: The study was carried out on 200 non-diabetic STEMI patients presenting to our university hospital within the first 8 hours of symptom onset. Patients were randomised into 2 groups , the intervention group received 10mg Empagliflozin before PPCI with the standard medical therapy while the control group received only the standard medical therapy. Patients were assessed for demographic data, risk factors, procedural outcomes, clinical and in-hospital outcomes, and short-term MACE up to 1 month. Results: Our study found a significant difference between the intervention and control groups regarding contrast volume with a mean of 131 ml in the intervention group and 144 ml in control group with a p value of 0.009, incidence of no-reflow with 34.5% in the control group and only 18.2% in the intervention group and a p value of 0.014 and myocardial blush grade (MBG) were 84.1% of the patients in intervention group had MBG III after PCI while only 65.5% of the patients in the control group showed the same results with a p value of 0.019. Also, there was a significant difference in St-segment resolution post PCI as 59.1% of patients in the intervention group had complete ST segment resolution and only 39.1% of the patients in the control group had complete resolution with a p-value of 0.027, and total MACE in the first month which affected 44.8% of the patients in the control group and only 28.4% of those in the intervention group with a p-value of 0.024. Conclusion Our study showed that pre-loading of STEMI patients with Empagliflozin resulted in improvement in procedural outcomes, decreasing the incidence of coronary no-reflow, improvement in patient’s course during hospital stay and short-term MACE. Improvement in MACE was mainly due to reduced HF hospitalisations and anginal symptoms.

Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis

Development of myocardial fibrosis in patients with aortic stenosis precedes left ventricular decompensation and is associated with an adverse long-term prognosis. To investigate whether early valve intervention reduced the incidence of all-cause death or unplanned aortic stenosis-related hospitalization in asymptomatic patients with severe aortic stenosis and myocardial fibrosis. This prospective, randomized, open-label, masked end point trial was conducted between August 2017 and October 2022 at 24 cardiac centers across the UK and Australia. Asymptomatic patients with severe aortic stenosis and myocardial fibrosis were included. The final date of follow-up was July 26, 2024. Early valve intervention with transcatheter or surgical aortic valve replacement or guideline-directed conservative management. The primary outcome was a composite of all-cause death or unplanned aortic stenosis-related hospitalization in a time-to-first-event intention-to-treat analysis. There were 9 secondary outcomes, including the components of the primary outcome and symptom status at 12 months. The trial enrolled 224 eligible patients (mean [SD] age, 73 [9] years; 63 women [28%]; mean [SD] aortic valve peak velocity of 4.3 [0.5] m/s) of the originally planned sample size of 356 patients. The primary end point occurred in 20 of 113 patients (18%) in the early intervention group and 25 of 111 patients (23%) in the guideline-directed conservative management group (hazard ratio, 0.79 [95% CI, 0.44-1.43]; P = .44; between-group difference, -4.82% [95% CI, -15.31% to 5.66%]). Of 9 prespecified secondary end points, 7 showed no significant difference. All-cause death occurred in 16 of 113 patients (14%) in the early intervention group and 14 of 111 (13%) in the guideline-directed group (hazard ratio, 1.22 [95% CI, 0.59-2.51]) and unplanned aortic stenosis hospitalization occurred in 7 of 113 patients (6%) and 19 of 111 patients (17%), respectively (hazard ratio, 0.37 [95% CI, 0.16-0.88]). Early intervention was associated with a lower 12-month rate of New York Heart Association class II-IV symptoms than guideline-directed conservative management (21 [19.7%] vs 39 [37.9%]; odds ratio, 0.37 [95% CI, 0.20-0.70]). In asymptomatic patients with severe aortic stenosis and myocardial fibrosis, early aortic valve intervention had no demonstrable effect on all-cause death or unplanned aortic stenosis-related hospitalization. The trial had a wide 95% CI around the primary end point, with further research needed to confirm these findings. ClinicalTrials.gov Identifier: NCT03094143.

Clinical study on the effects of cluster needling at scalp points with needle retaining combined with the training of the upper-limb intelligent rehabilitation robot on shoulder function in stroke patients during convalescence

To explore the effects of cluster needling at scalp points with needle retaining combined with the training of the upper-limb intelligent rehabilitation robot on shoulder function in stroke patients during convalescence. Ninety stroke patients during convalescence were collected and randomized into scalp point group, robot training group and combined intervention group, with 30 cases each. In the scalp point group, the cluster needling was delivered at scalp points with the needles retained. In the robot training group, the patients were trained with the upper-limb intelligent rehabilitation robot. In the combined intervention group, the patients received both the cluster needling and the training of the upper-limb intelligent rehabilitation robot. In each group, the treatment was given once daily, 5 treatments a week with 2 days rest, for consecutive 4 weeks. Separately, before and after treatment, the score of Fugl-Meyer assessment upper extremity scale (FMA-UE) and the score of activity of daily living (ADL) were evaluated. Using the in-built assessment system of the upper-limb intelligent rehabilitation robot, the range of motion (ROM) of forward flexion, horizontal abduction and horizontal adduction of the affected shoulder joint were evaluated. With surface electromyogram (sEMG), the sEMG value of the deltoid muscle and the pectoralis major on the affected side were detected. Compared with the values before treatment, ADL score and FMA-UA score increased in patients of the three groups (P<0.05), and ROM of forward flexion, horizontal abduction and horizontal adduction of the affected shoulder joint was larger (P<0.05), the sEMG value of the fasciculi pectoralis major anterior of patients in the combined intervention group was reduced (P<0.05), and the sEMG of anterior deltoid tract was elevated in the three groups (P<0.05). When compared with the scalp point group and the robot group, in the combined intervention group, after treatment, ADL score and FMA-UA score were higher (P<0.05), ROM of forward flexion, horizontal abduction and horizontal adduction of the affected shoulder joint elevated (P<0.05) and sEMG value of the fasciculi pectoralis major anterior reduced (P<0.05), while which of the anterior deltoid tract was elevated (P<0.05). The cluster needling at scalp points with needle retaining, combined with the training of the upper-limb intelligent rehabilitation robot, improves the upper limb motor function and the range of motion of the shoulder joint in stroke patients during convalescence.

Music-Based Therapy for the Treatment of Perioperative Anxiety and Pain-A Randomized, Prospective Clinical Trial.

Background: Music-based intervention has been advocated as a nonpharmacologic approach for the perioperative control of pain and anxiety in surgical patients. However, its impact on patients with preoperative anxiety has not been clearly established. Our study aimed to examine the impact of music-based intervention administered before, during, and after surgery on postoperative opioid consumption and pain levels, as well as preoperative anxiety, depression, and pain catastrophizing. We hypothesized that, compared to a control group, music-based intervention would be effective in reducing opioid requirements and mood disorders. Methods: This study was a single-center, prospective, single-blinded, randomized controlled trial. Inclusion criteria isame-day or observation surgery. Exclusion criteria included American Society of Anesthesiologists physical status IV, use of spinal anesthesia, PROMIS Anxiety T-scores ≤ 57.4 and ≥74.1, preoperative chronic opioid use, transgender surgery, and history of drug or alcohol abuse. Music-based intervention was developed by a certified music therapist. Each patient was randomized to receive standard of care (SC) or SC plus music-based intervention before, during, and after surgery. The primary end point was postoperative oral morphine equivalents (OMEs) over 5 days following surgery using the area under the curve (AUC)Secondary end points were PROMIS Anxiety, PROMIS Depression scores Pain Catastrophizing Scale scores, postoperative nausea and vomiting, time of hospital discharge, and patient satisfaction (0 = totally unsatisfied to 10 = completely satisfied). Results: A total of 75 patients were randomized to a music-based intervention (n = 33) or control (n = 42) group. Patients in the music-based intervention group consumed 56.7% less opioids than those in the control group (AUC was 2.8 in the music-based intervention group vs. 6.4 in the control group, absolute standardized mean difference (aSMD) = 0.34 (-0.17, 0.85)). No difference in pain scores was recorded between groups. Music-based intervention also reduced anxiety on postoperative day (POD)2 (aSMD = 0.38 (-0.16, 0.91)), depression on POD2 (aSMD = 0.31 (-0.23, 0.84)) and POD4 (aSMD = 0.24 (-0.29, 0.77)), and pain catastrophizing on POD1 (aSMD = 0.24 (-0.3, 0.77)). Conclusions: Our data support the use of music-based intervention to reduce postoperative opioid requirements. Music-based intervention may also reduce anxiety, depression, and pain catastrophizing.

ChatGPT-4 and wearable device assisted Intelligent Exercise Therapy for co-existing Sarcopenia and Osteoarthritis (GAISO): a feasibility study and design for a randomized controlled PROBE non-inferiority trial.

Sarcopenia and osteoarthritis are prevalent age-related diseases that mutually exacerbate each other, creating a vicious cycle that worsens both conditions. Exercise is key to breaking this detrimental cycle. Facing increasing demand for rehabilitation services within this patient demographic, ChatGPT-4 and wearable device may increase the availability, efficiency and personalization of such health care. To evaluate the clinical efficacy and cost-effectiveness of a rehabilitation system implemented on mobile platforms, utilizing the integration of ChatGPT-4 and wearable devices. The study design is a prospective randomized open blinded end-point (PROBE) non-inferiority trial. 278 patients diagnosed with osteoarthritis and sarcopenia will be recruited and randomly assigned to the intervention group and the control group. In the intervention group patients receive mobile phone-based rehabilitation service where ChatGPT-4 generates personalized exercise therapy, and wearable device guides and monitor the patient to implement the exercise therapy. Traditional clinic based face-to-face exercise therapy will be prescribed and implemented in the control group. All patients will receive three-months exercise therapies following the frequency, intensity, type, time, volume and progression (FITT-VP) principle. The patients will be assessed at baseline, one month, three months, and six months after initiation. Outcome measures will include ROM, gait patterns, Visual Analogue Scale (VAS) for pain assessment, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS) for functional assessment, Short-Form Health Survey 12 (SF-12) for quality of life, Minimal Clinically Important Difference (MCID), Patient Acceptable Symptom State (PASS), and Substantial Clinical Benefit (SCB) for clinically significant measures. A rehabilitation system combining the capabilities of ChatGPT-4 and wearable devices potentially enhance the availability and efficiency of professional rehabilitation services, thus enhancing the therapeutic outcomes for a substantial population concurrently afflicted with sarcopenia and osteoarthritis.

The effect of preadmission education given to bariatric surgery patients on postoperative recovery: A randomized controlled study.

To investigate the effect of preadmission education given to laparoscopic sleeve gastrectomy patients on preoperative and postoperative anxiety, postoperative pain, and patient vital signs. The study was designed as randomized, controlled, experimental, and single-blind. This study was conducted with 68 patients who met the inclusion criteria and underwent laparoscopic sleeve gastrectomy in the general surgery clinic of a university hospital between December 2022 and October 2023. Data were collected using the 'Perioperative Form,' 'Visual Analog Scale,' and 'State Anxiety Scale I-II.' Intervention group patients were informed and educated about the surgical process in the outpatient clinic. The anxiety levels of all patients were determined with the State Anxiety Scale the day before surgery. In the postoperative period, vital signs (once), anxiety (on the first day after surgery), and pain levels (eight times during 48 h) were measured. In the analysis between the groups, the difference between the duration of postoperative hospital stay (p = 0.007), pain (p = 0.000 for all measured), and anxiety levels (p = 0.000) was statistically significant. There were also significant differences in the diastolic blood pressure (p = 0.007), body temperature (p = 0.000), and saturation values (p = 0.000). Patients' readiness level for surgery was the most influential factor in postoperative pain levels (p = 0.000). The education given to the patients before hospitalization decreased preoperative and postoperative anxiety levels, postoperative hospital stay and pain levels, and positively affected diastolic blood pressure, body temperature and saturation levels. One-to-one education given to patients in the outpatient clinic also contributes positively to their readiness for surgery. This study provides valuable evidence to the wider global clinical community by demonstrating the important benefits of preadmission education for patients undergoing bariatric surgery. Implementation of similar educational interventions in diverse healthcare settings worldwide may lead to increased postoperative recovery and improved overall patient well-being after bariatric surgery.