Care Control Group Research Articles

Influence of humanistic care on negative emotions, nursing quality, and patient satisfaction in outpatient gynecological surgery.

To explore the impact of humanistic care on negative emotions, nursing quality and patient satisfaction among women undergoing outpatient gynecological surgery. This retrospective study involved 108 patients who underwent outpatient gynecological surgery at the Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine between August 2022 and August 2023. The patients were divided into two groups: 51 patients received routine care (control group) and 57 received humanistic care (experimental group). Data collected included vital signs (heart rate [HR] and systolic/diastolic blood pressure [SBP/DBP]), pain levels (Visual Analogue Scale [VAS] scores at 12 and 24 hours postoperative), negative emotions (Self-rating Anxiety/Depression Scale [SAS/SDS]), comfort (Kolcaba's General Comfort Questionnaire [GCQ]), sexual functioning (Brief Index of Sexual Functioning for Women), nursing quality (errors, defects, and complaints) and patient satisfaction. Intraoperative SBP, DBP, along with HR, were significantly lower in the experimental group compared to the control group (all P<0.05). Postoperative pain levels at both 12 and 24 hours were also significantly reduced in the experimental group (both P<0.01). Furthermore, the experimental group demonstrated significant reductions in SAS and SDS scores and higher GCQ scores across physical, psychospiritual, environmental, and sociocultural dimensions (all P<0.05). There were no significant differences between the groups in terms of sexual desire, activity, and satisfaction (all P>0.05). Nursing quality was significantly better (P=0.029) and patient satisfaction with nursing care was higher (P=0.015) in the experimental group. Humanistic care significantly reduces negative emotions and enhances comfort, nursing quality, and patient satisfaction in women undergoing outpatient gynecological surgery. This approach does not affect sexual functioning indicators but offers substantial improvements in overall patient care and outcomes. Its high value for clinical promotion underscores its potential as a transformative approach in outpatient gynecological settings.

Effectiveness and cost-effectiveness of an integrated digital psychological intervention (EmoEase) in Chinese chronic obstructive pulmonary disease patients: Study protocol of a randomized controlled trial.

Mental health problems in patients with chronic obstructive pulmonary disease (COPD) are common and frequently neglected. Digital psychological interventions may reduce mental health problems, but their effectiveness has not been evaluated in the Chinese COPD population. In this study, we will develop an integrated digital psychological intervention (EmoEase) and evaluate its effectiveness and cost-effectiveness in enhancing the mental wellbeing of patients with COPD in China. This study is a multicenter, two-arm, randomized controlled trial (RCT) with a parallel-group design to enroll at least 420 patients with COPD with age over 35 years. Participants will be assigned to receive either usual care (control group) or usual care + EmoEase (intervention group). Assessments will take place at baseline (T0) and 4 weeks (T1), 8 weeks (T2), and 16 weeks (T3) after baseline, and participants will be asked to complete questionnaires and physical measurements. The primary outcome measure will assess mental wellbeing using the Warwick Edinburgh Mental Wellbeing Scale (WEMWBS). Secondary outcome measures will assess mental health, physical health, COPD symptoms, health risk behaviors, socioeconomic indicators, and healthcare utilization and expenditure. Analyses will utilize an intention-to-treat approach. This is the first RCT to examine the value of EmoEase, a novel digital psychological intervention for patients with COPD. If this intervention is effective and cost-effective, it could be rapidly scaled up to provide mental healthcare for patients with COPD in China. ClinicalTrials.gov Identifier: NCT06026709. Date of first submission: 30 August 2023. https://clinicaltrials.gov/study/NCT06026709.

Impact of Program Changes Including Telemedicine and Telephonic Care During the COVID-19 Pandemic in Preventing 30-Day Hospital Readmission for Patients in a Care Transitions Program.

To describe health outcomes of older adults enrolled in the Mayo Clinic Care Transitions (MCCT) program before and during the COVID-19 pandemic compared to unenrolled patients. We conducted a retrospective cohort study of adults (age >60 years) in the MCCT program compared to a usual care control group from January 1, 2019, to September 20, 2022. The MCCT program involved a home, telephonic, or telemedicine visit by an advanced care provider. Outcomes were 30- and 180-day hospital readmissions, emergency department (ED) visit, and mortality. We performed a subgroup analysis after March 1, 2020 (during the pandemic). We analyzed data with Cox proportional hazards regression models and hazard ratios (HRs) with 95% CIs. Of the 1,012 patients total, 354 were in the MCCT program and 658 were in the usual care group with a mean (SD) age of 81.1 (9.1) years overall. Thirty-day readmission was 16.9% (60 of 354) for MCCT patients and 14.7% (97 of 658) for usual care patients (HR, 1.24; 95% CI, 0.88-1.75). During the pandemic, the 30-day readmission rate was 15.1% (28 of 186) for MCCT patients and 14.9% (68 of 455) for usual care patients (HR, 1.20; 95% CI, 0.75-1.91). There was no difference between groups for 180-day hospitalization, 30- or 180-day ED visit, and 30- or 180-day mortality. Numerous factors involving patients, providers, and health care delivery systems during the pandemic most likely contributed to these findings.

A randomized controlled study of auricular point acupressure to manage chemotherapy-induced neuropathy: Study protocol.

Chemotherapy-induced neuropathy (CIN) significantly impacts cancer patients, leading to functional disability, diminished quality of life, and increased healthcare costs amid the ongoing opioid crisis. Auricular point acupressure (APA), a non-invasive and non-pharmacological alternative, has shown potential for alleviating the pain, numbness, and tingling associated with CIN. This study aims to assess the efficacy of APA for CIN symptoms and physical function and to examine the mechanisms underlying APA's effects on CIN. This is a three-arm randomized controlled clinical trial protocol. Patients aged 18 and older who are experiencing CIN are randomly assigned to one of the three groups: an APA group (in-person APA; mAPA), a sham control group (virtual APA; vAPA), and a wait-list usual care control group (UC). During the four-week program, participants in the mAPA receive an in-person APA treatment and training; the sham control participants (vAPA) receive a self-guided smartphone APA application with APA demonstration videos; and the UC participants will continue with the usual care and be re-randomized into one of the APA groups. The primary outcomes are changes in CIN symptoms and physical function. Secondary outcomes include evaluating pain sensory thresholds, motor and cognitive functioning, inflammatory signaling, brain connectivity, opioid use, and quality of life. The outcomes are measured at baseline, program completion (4 weeks), and at monthly follow-up for 3 months post-intervention. This study will provide evidence supporting the potential viability of APA as an intervention for CIN. ClinicalTrials.gov, ID NCT04920097 registered on 3 June 2021.

Perioperative Intra-articular Infiltration of Tranexamic Acid and Ropivacaine Cocktail in Bilateral Total Knee Replacement

Objective: This study evaluated the efficacy and safety of perioperative intra-articular infiltration with a tranexamic acid and ropivacaine cocktail in patients undergoing bilateral total knee replacement (TKR). Methods: A randomized controlled trial was conducted involving 50 patients scheduled for elective bilateral TKR. Participants were randomly assigned to receive either intra-articular infiltration of a tranexamic acid and ropivacaine cocktail (intervention group) or standard care (control group). Outcome measures included postoperative blood loss, pain scores, range of motion, and adverse events. Results: Among the enrolled patients (n=50), the intervention group demonstrated reduced postoperative blood loss, evidenced by higher hemoglobin levels and lower drain output than the control group. Additionally, the intervention group exhibited consistently lower pain scores at various postoperative time points and greater improvements in range of motion. Conclusion: Intra-articular infiltration with a tranexamic acid and ropivacaine cocktail in bilateral TKR patients showed promising outcomes, including reduced blood loss, improved pain control, and enhanced range of motion. These findings suggest the potential of this adjunctive therapy in optimizing perioperative care for patients undergoing bilateral TKR. However, further research with larger sample sizes is warranted to validate these preliminary results and establish this intervention’s long-term efficacy and safety.

An Integrated Stroke Transitional Care Intervention Improves Physical Functioning, Self-Management and Patient Experience in Older Adults with Stroke and Multimorbidity: A Multisite Pragmatic Randomized Controlled Trial

Background: The hospital-to-home transition for older adults with stroke is often fragmented, resulting in hospital readmissions and reduced quality of life, patient satisfaction and safety. There is limited evidence for strategies to improve transitions in care for older adults with stroke and multimorbidity. This study aimed to test, in real-world clinical practice, the effectiveness of the Transitional Care Stroke Intervention (TCSI) versus usual care on health outcomes, patient experience, and health and social service use costs in older adults (&gt; 55 years) with stroke and multimorbidity (&gt; 2 chronic conditions).&#x0D; Methods: This pragmatic randomized controlled trial was conducted among older adults with a stroke and multimorbidity discharged from the hospital to the community using outpatient stroke rehabilitation services in two communities in Ontario, Canada. Participants were randomized 1:1 to usual care (control group) or usual care plus the 6-month TCSI (intervention group). The TCSI was delivered virtually by an interprofessional team from hospital-based outpatient stroke rehabilitation clinics (Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Nurse, and Social Worker). The TCSI is a complex, integrated intervention which includes care coordination/system navigation support, phone/video visits, monthly interprofessional case conferences, and an online resource to support system navigation. Data analysis was performed by intention to treat. The primary outcome was risk of hospital readmission (all-cause) after 6 months. Secondary outcomes were mental and physical functioning, depressive symptoms, stroke self-management, patient experience, number of hospital days and readmissions, number of ED visits, survival rates to first hospital and ED visit, risk of ED visits, and health and social service use costs. Older adults with stroke were engaged as co-investigators and informed the research design, implementation, and evaluation through participation in the Patient Partner Advisory and the TCSI Steering Committees.&#x0D; &#x0D; Results: Ninety participants were enrolled (44 intervention, 46 control); 11 (12%) participants were lost to follow-up, leaving 79 (39 intervention, 40 control). Most participants were men (60%), with an average of 7 comorbid conditions, and 78% had experienced their first-ever stroke. No significant group differences were seen for the baseline to six-month risk of hospital readmission (all-cause). However, stroke survivors in the intervention group reported higher levels of physical functioning (SF-12 Physical Component Summary Score mean difference: 5.10; 95% CI: 1.58-8.62, p=0.005), stroke self-management (Southampton Stroke Self-Management Questionnaire mean difference: 6.00; 95% CI: 0.51—11.50, p=0.03), and patient experience (Person-Centred Coordinated Care Experiences Questionnaire mean difference: 2.64, 95% CI: 0.81, 4.47, p=0.005) compared with the usual care group. No significant group differences were seen for the other secondary outcomes.&#x0D; Discussion: The TCSI improved physical functioning, stroke self-management and patient experience in older adults with stroke and multimorbidity without increasing total healthcare costs compared to usual care.&#x0D; Conclusion:The results provide evidence for the effectiveness of an integrated intervention to optimize transitional care outcomes for older adults with stroke and multimorbidity receiving outpatient stroke rehabilitation services.&#x0D; Suggestions for future research: Future research is needed to further evaluate this intervention in diverse settings and populations, with a larger sample size and a full economic evaluation. &#x0D; &#x0D; &#x0D;

WHEN OLDER ADULTS GOT TRAUMATIC INJURY: EFFECTS OF CASE MANAGEMENT

Abstract Case management can improve patient outcomes from the acute to rehabilitation phase after traumatic injury. However, a lack of evidence on effects of case management in older patients with traumatic injury makes it difficult to translate research findings into practice. The study was to examine the effects of a case management intervention on illness perception, coping strategies used, and quality of life in older patients with traumatic injury across a 9-month span after hospital discharge. A 4-wave longitudinal, experimental design was used in older patients with traumatic injury hospitalized at a regional hospital in Taiwan. Subjects were randomly assigned to case management (experimental) or usual care (control) group. The intervention started during hospitalization and ended with a phone follow-up two weeks post discharge. Illness perception and/or coping strategies used along with health-related quality of life were measured at baseline, 3, 6 and 9 months after discharge. Generalized estimating equations were used for analysis. Findings showed significant differences of illness perceptions at 3 and 6 months as well as coping strategies used at 6 and 9 months after discharge between the two groups. However, no significant difference on quality of life over time between the two groups was found. While case management appears to help older patients with traumatic injury decrease illness perception and better cope with their injury, it does not significantly improve their quality of life nine months after discharge. It is recommended that healthcare professionals develop a comprehensive long-term case management program for older patients with traumatic injury.

PRIMARY OUTCOMES FROM CAREGIVER-REPORTED SURVEYS IN THE SHARE TRIAL

Abstract This presentation will introduce SHARE, a randomized-controlled trial to proactively engage family caregivers and normalize advance care planning in primary care. The objective of the study is to engage family caregivers in longitudinal interactions with primary care clinicians and stimulate and support ACP discussions in primary care. We focus on persons with mild, moderate, and severe cognitive impairment regardless of clinical diagnosis because of the importance of addressing advance care planning early in the disease trajectory, the under-diagnosis of ADRD, and because of the greater implementation potential of a protocol with broader applicability. We will describe the study design and present on 6-month outcomes to test our hypothesis that as compared with the minimally enhanced control care group, caregivers in the intervention group will report better quality of communication about end-of-life care with primary care clinicians at 6 months (primary outcome).

Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau).

Advanced cancer significantly impacts patients' and family caregivers' quality of life. When patients and caregivers are supported concurrently as a dyad, the well-being of each person is optimized. Family, Outlook, Communication, Uncertainty, Symptom management (FOCUS) is a dyadic, psychoeducational intervention developed in the United States, shown to improve the well-being and quality of life of patients with advanced cancer and their primary caregivers. Originally, a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery. The aims of this study are to (1) adapt FOCUS to the Australian context (FOCUSau); (2) evaluate the effectiveness of FOCUSau in improving the emotional well-being and self-efficacy of patients with advanced cancer and their primary caregiver relative to usual care control group; (3) compare health care use between the intervention and control groups; and (4) assess the acceptability, feasibility, and scalability of FOCUSau in order to inform future maintainable implementation of the intervention within the Australian health care system. FOCUS will be adapted prior to trial commencement, using an iterative stakeholder feedback process to create FOCUSau. To examine the efficacy and cost-effectiveness of FOCUSau and assess its acceptability, feasibility, and scalability, we will undertake a hybrid type 1 implementation study consisting of a phase 3 (clinical effectiveness) trial along with an observational implementation study. Participants will include patients with cancer who are older than 18 years, able to access the internet, and able to identify a primary support person or caregiver who can also be approached for participation. The sample size consists of 173 dyads in each arm (ie, 346 dyads in total). Patient-caregiver dyad data will be collected at 3 time points-baseline (T0) completed prerandomization; first follow-up (T1; N=346) at 12 weeks post baseline; and second follow-up (T2) at 24 weeks post baseline. The study was funded in March 2022. Recruitment commenced in July 2024. If shown to be effective, this intervention will improve the well-being of patients with advanced cancer and their family caregivers, regardless of their location or current level of health care support. ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128. PRR1-10.2196/55252.

Jelly snakes to reduce early postoperative vomiting in children after adenotonsillectomy: The randomized controlled snakes trial

BackgroundDespite the use of dual antiemetic agents, postoperative nausea and vomiting (PONV) occurs in an unacceptably large number of patients post-tonsillectomy. There has been increased interest in alternative and non-pharmacological treatments for PONV e.g., chewing gum. We investigated if chewing a large confectionary jelly snake had prophylactic antiemetic effects postoperatively in young children. MethodsProspective, open-label randomised controlled trial of 240 patients, 2–16 years. Patients administered a confectionary jelly snake to chew postoperatively were compared with a control group. The primary outcome was the number of episodes of vomiting within 6 h of the operation on an intention-to-treat basis. Secondary outcomes: incidence of nausea, vomiting at 6 and 24 h, rescue antiemetic use, acceptability, delayed discharge. Results233 patients were randomised to receive the confectionary snake (snake group, 118) or standard care (control group, 115). The number of vomiting episodes in 6 h was similar between groups on an intention-to-treat basis, with 39 episodes across 22 (19%) patients in the control group and 31 across 19 (16%) patients in the snake group (p = 0.666). From post anaesthetic care unit until 24 h there was no difference in doses of antiemetics or delayed discharge due to PONV. A secondary as per protocol analysis did not change this result. ConclusionsChewing of confectionery jelly snakes within one hour of waking following adenotonsillectomy with vapour-maintained anaesthesia and two prophylactic antiemetics did not further reduce the incidence of early vomiting. Registrationprospective registration at the Australia and New Zealand Clinical Trials Registry (ACTRN12618000637246).

Comparison of erector spinae plane block and serratus anterior plane block for postoperative analgesia in uniportal thoracoscopic lobectomy: a randomized controlled trial

BackgroundPostoperative pain remains a significant concern following uniportal thoracoscopic surgery. The analgesic efficacy of erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) in terms of postoperative opioid consumption in uniportal thoracoscopic surgery still needs further studies.MethodsA randomized controlled trial was conducted, enrolling 150 patients who underwent uniportal thoracoscopic lobectomy. The patients were randomly allocated to three groups in a 1:1:1 ratio: the ESPB group (administered 20 ml of 0.5% ropivacaine), the SAPB group (administered 20 ml of 0.5% ropivacaine), and the standard care (control) group. The primary endpoint was the consumption of sufentanil during the first 24 h following surgery. Secondary endpoints assessed the area under the curve (AUC) of pain numerical rating scale (NRS) scores, occurrence of moderate to severe pain, time to initial sufentanil request, and postoperative adverse events.ResultsNo significant difference was observed in the consumption of sufentanil during the first 24 h following surgery between the ESPB and SAPB groups (adjusted difference, 1.53 [95% CI, -5.15 to 2.08]). However, in comparison to the control group, both intervention groups demonstrated a significant decrease in sufentanil consumption, with adjusted differences of -9.97 [95% CI, -13.10 to -6.84] for the ESPB group and -12.55 [95% CI, -15.63 to -9.47] for the SAPB group. There were no significant differences in AUC of NRS scores during rest and movement between the ESPB and SAPB groups, with adjusted differences of -7.10 [95% CI, 1.33 to -15.55] for the rest condition and 5.61 [95% CI, -13.23 to 2.01] for the movement condition. At 6 h postoperatively, there were fewer patients with moderate to severe pain in the ESPB group compared with those in the SAPB group (adjusted difference, -1.37% [95% CI, -2.29% to -0.45%]. The time to first sufentanil request significantly differed among the three groups (ESPB vs Control P < 0.01, SAPB vs Control P < 0.01, ESPB vs SAPB P = 0.015).ConclusionsIn patients undergoing uniportal thoracoscopic lobectomy, although the differences between the two groups are not statistically significant, both the ESPB and SAPB demonstrate effective reduction in postoperative opioid consumption and the need for rescue analgesics compared to the control group. Moreover, the ESPB group experienced a significantly lower incidence of moderate to severe pain at 6 h postoperatively compared to the SAPB group.Trial registrationThe study was registered in the Chinese Clinical Trial Registry (registration No: ChiCTR1900021695, Date of registration: March 5th, 2019).

Role of Yoga Therapy in Prevention of Tuberculosis in People Living with HIV Infection: Protocol for A Randomized Controlled Trial

Background: TB is a common opportunistic infection (OI) among people living with Human Immunodeficiency Virus (PLHIV). PLHIV often resort to the use of traditional and complementary medicine (T&amp;CM) to supplement ART in order to maintain and improve their health. Yoga therapy has vast potential and beneficial effects on lungs. This study will assess the proportion of PLHIV developing TB in intervention group as compared to the control group. The secondary objective is to assess the improvement in CD4 T cell count, development of other OIs and to explore the socio-behavioural factors affecting the adherence to yoga programme and ART. Methods: We propose a hospital-based RCT comparing the yoga group with usual care control group using quantitative methods for 3 years. A total of 1800 PLHIVs will be studied with 1:2 intervention to control group ratio. Each participant will be involved for 24 months (intervention delivery/follow-up). PLHIV in the intervention group will be given yoga therapy training of 45- minute duration once a month for 3-months followed by self-practice at home. Independent t tests and Z test for proportion will be used to compare the two groups at baseline. Intention to treat analyses will be conducted with participants as originally allocated at randomization to avoid bias. Alpha level will be set at 5%, using two-tailed for all inferences. Discussion: This study will generate preliminary data about effect of yoga on TB and other opportunistic infections as well as the feasibility and utility of further RCT in the domain. Trial Registration: ISRCTN74208821

Role of the NeuroCuple™ Device for the Postoperative Pain Management of Patients Undergoing Unilateral Primary Total Knee and Hip Arthroplasty: A Pilot Prospective, Randomized, Open-Label Study

Background: The potential effectiveness of the non-pharmacological and nanotechnology-based NeuroCuple™ device in reducing postoperative surgical pain and opioid consumption remains unknown. Methods: This randomized controlled open-label study was conducted in patients undergoing a primary unilateral total knee or total hip arthroplasty. In the recovery room, patients were randomized to receive either standard of care (control group) or standard of care plus two NeuroCuple™ devices. The outcome variables included pain and opioid consumption (oral morphine equivalent, OME in milligrams). Results: A total of 69 patients were randomized to either the NeuroCuple™ group (n = 38) or the control group (n = 31). Use of the NeuroCuple™ devices was associated with a significant 34% reduction in pain at rest (means of area under the curve: 6.3 vs. 9.5; p = 0.018) during postoperative days 1–3. Opioid consumption was reduced by 9%. More importantly, use of the NeuroCuple™ devices reduced the number of patients requesting an opioid prescription following discharge from the hospital by 52% (26% vs. 55%, p = 0.016). Conclusions: Our data suggest that the NeuroCuple™ device may be an effective non-pharmacological alternative to opioids to manage postoperative pain following unilateral arthroplasty due to its ability to reduce postoperative opioid use.

Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma

BackgroundPost-traumatic stress symptoms develop in a quarter to half of injured children affecting their longer-term psychologic and physical health. Evidence-based care exists for post-traumatic stress; however, it is not readily available in some communities. We have developed an eHealth program consisting of online, interactive educational modules and telehealth therapist support based in trauma-focused cognitive behavioral therapy, the Reducing Stress after Trauma (ReSeT) program. We hypothesize that children with post-traumatic stress who participate in ReSeT will have fewer symptoms compared to the usual care control group.MethodsThis is a randomized controlled trial to test the effectiveness of the ReSeT intervention in reducing symptoms of post-traumatic stress compared to a usual care control group. One hundred and six children ages 8–17 years, who were admitted to hospital following an injury, with post-traumatic stress symptoms at 4 weeks post-injury, will be recruited and randomized from the four participating trauma centers. The outcomes compared across groups will be post-traumatic stress symptoms at 10 weeks (primary outcome) controlling for baseline symptoms and at 6 months post-randomization (secondary outcome).DiscussionReSeT is an evidence-based program designed to reduce post-traumatic stress symptoms among injured children using an eHealth platform. Currently, the American College of Surgeons standards suggest that trauma programs identify and treat patients at high risk for mental health needs in the trauma system. If effectiveness is demonstrated, ReSeT could help increase access to evidence-based care for children with post-traumatic stress within the trauma system.Trial registrationClinicalTrials.gov NCT04838977. 8 April 2021.

A Positive Psychology Intervention in Allogeneic Hematopoietic Stem Cell Transplantation Survivors (PATH) to Promote Well-Being: Randomized Controlled Feasibility and Preliminary Efficacy Trial

Background: Patients with hematologic malignancies who are allogeneic hematopoietic stem cell transplantation (HSCT) survivors experience tremendous psychological symptoms (e.g., anxiety and depression symptoms) and low levels of positive psychological well-being (e.g., flourishing, gratitude), which further undermine multiple health-related outcomes such as quality of life (QOL). However, supportive oncology interventions which specifically target positive psychological well-being may buffer against psychological distress and promote QOL. Thus, we developed and piloted a novel phone-delivered positive psychology intervention (PATH) to improve QOL and symptoms of anxiety and depression in HSCT survivors transplanted for hematologic malignancies. Methods: We conducted a randomized controlled trial (NCT05147311) to assess feasibility, acceptability, and preliminary efficacy of the PATH intervention. From August 2021 to August 2022, 70 HSCT survivors who were 100-days post-HSCT were randomly assigned to either PATH or a usual care control group. The PATH group had 9 weekly 1:1 phone sessions of positive psychology exercises focused on gratitude, strengths, and meaning. The Usual care group had routine sessions with the transplant social worker. We defined feasibility as &amp;gt;60% of eligible participants enrolling in the study and &amp;gt;75% of intervention group participants completing at least 6 of the 9 positive psychology sessions. At baseline and 9 and 18 weeks after baseline, patients self-reported optimism (Life Orientation Test Revised), gratitude, (Gratitude Questionnaire-6), flourishing (Flourishing Scale), QOL (Functional Assessment of Cancer Therapy-Bone Marrow Transplant) and depression and anxiety (Hospital Anxiety and Depression Scale). We used mixed effects regression analyses to determine the potential impact of PATH on QOL and symptoms of anxiety and depression. Results: The average age (standard deviation) of participants was 56.8 (13.7) years; 50% (N=35) were female. The majority of the participants identified as White (91.4%; N=64), married or living with a partner (71.4%; N=50), had at least a college education (67.2%; N=47) and were on disability or retired (87.1%; N=67). The majority had a diagnosis of leukemia (68.6%; N=48), underwent reduced intensity conditioning (62.9%; N=44), and did not have acute graft-versus-host disease (68.6%; N=48). For our feasibility metrics, we enrolled 68.6% (72/105) of eligible patients, two of which were not randomized due to worsening physical symptoms. Additionally, 94% (95% CI: 79%-99%) of those who started the PATH intervention completed all nine intervention sessions. For acceptability, participants in the intervention group reported positive psychology exercises as easy to complete (mean [95% CI] = 7.40 [6.87, 7.92] on a scale of 0-10) and useful (mean [95% CI] = 8.23 [7.83, 8.63]). Compared with usual care, participants in the intervention group reported less symptoms of anxiety ( d=0.46, p=0.027), and demonstrated promising improvements in gratitude ( d=0.26) at 9 weeks. We did not observe significant differences in QOL and depression symptoms. Conclusions: A positive psychology intervention, PATH, is feasible, acceptable, and has potential to improve outcomes in patients with hematologic malignancies who are allogeneic HSCT survivors. Larger trials are needed to examine the impact of PATH on psychological well-being and QOL in this population.

Effects of acupoints-based TENS combined with tDCS on spasticity and motor function in ischemic stroke with spastic hemiplegia: study protocol for a randomized controlled trial

BackgroundSpastic hemiplegia following ischemic strokes seriously impedes the recovery of motor function posing a vast rehabilitation challenge. As the uncertain effects of recommended conventional treatments such as botulinum toxin injections on active functional improvement and potential adverse effects cannot be bypassed, there is an increasing need in alternative, more effective and safer modalities. Acupoints-based transcutaneous electrical nerve stimulation (Acu-TENS) and transcranial direct current stimulation (tDCS) are effective non-invasive modalities for stroke rehabilitation, particularly showing anti-spastic effect and functional improvements as well. However, the optimal stimulation frequency of Acu-TENS and whether combination of Acu-TENS and tDCS exert synergistic effect remain to be investigated.ObjectiveTo evaluate the effects of Acu-TENS combined with tDCS on spasticity and motor function in ischemic stroke patients with spastic hemiplegia and screen the optimal frequency of Acu-TENS.MethodsA total of 90 post-ischemic stroke patients with spastic hemiplegia will be intervened for 4 weeks and followed up for 4 weeks. They will be randomly assigned to three groups including two observation groups and a standard care control group in a 1:1:1 ratio. All patients will receive standard care and regular rehabilitation accordingly. In addition, the two observation groups will receive 12 sessions of Acu-TENS at 20 Hz or 100 Hz for 30 min combined with 1 mA tDCS for 20 min, three times a week, for 4 weeks. The primary outcome is the change in total modified Ashworth scale (MAS) score from baseline to week 4. Secondary outcomes include changes in surface electromyography (SEMG), Fugl-Meyer Motor Function Scale, Modified Barthel Index (MBI), and 10-meter walk test from baseline to week 4. MAS score will also be measured after 4 weeks of follow-up. Adverse events throughout the study will be recorded.DiscussionThis trial will evaluate, for the first time, the therapeutic potentials and safety of Acu-TENS combined with tDCS on spasticity and motor function in stroke patients. It will provide evidence for frequency-dependent anti-spastic effect of Acu-TENS, and a reference for rated parameter setting of new mixed transcutaneous and transcranial stimulation system for stroke rehabilitation, thereby promoting proactive healthcare consequently.Trial registration:Chinese Clinical Trials Register ChiCTR2200067186.

Noninvasive hemoglobin monitoring for maintaining hemoglobin concentration within the target range during major noncardiac surgery: A randomized controlled trial

Study objectiveThe effect of noninvasive CO-oximetry hemoglobin (SpHb) monitoring on the clinical outcomes of patients undergoing surgery remains unclear. This trial aimed to evaluate whether SpHb monitoring helps maintain hemoglobin levels within a predefined target range during major noncardiac surgeries with a potential risk of intraoperative hemorrhage. DesignA single-center, prospective, randomized controlled trial. SettingUniversity hospital. PatientsOne hundred and thirty patients undergoing elective noncardiac surgery with a potential risk of hemorrhage. InterventionsPatients were randomly allocated to undergo either SpHb-guided management (SpHb group) or usual care (control group). MeasurementsThe primary outcome was the rate of deviation of the total hemoglobin concentration (determined from laboratory testing) from a pre-specified target range (8–14 g/dL). This was defined as the number of laboratory tests revealing such deviations divided by the total number of laboratory tests performed during the surgery. Main resultsThe primary outcome occurred significantly less frequently in the SpHb group as compared to that in the control group (15/555 [2.7%]) vs. 68/598 [11.4%]; relative risk, 0.24; 95% confidence interval, 0.13–0.41; P < 0.001). Fewer point-of-care blood tests were performed in the SpHb group than in the control group (median [interquartile range], 2 [1–4] vs. 4 [2–5]; P < 0.001). There were no significant intergroup differences in the number of patients who received red blood cell transfusions during surgery (SpHb vs. control, 33.8% vs. 46.2%; P = 0.201). The incidence of unnecessary red blood cell preparation (>2 units) was lower in the SpHb group than in the control group (3.1% vs. 16.9%; P = 0.024). ConclusionsCompared with routine care, SpHb-guided management resulted in significantly lower rates of hemoglobin deviation outside the target range intraoperatively in patients undergoing major noncardiac surgeries with a potential risk of hemorrhage. Clinical trial registrationClinicalTrials.gov (identifier: NCT03816514).

Effect of neuromuscular electrical stimulation and early physical activity on ICU-acquired weakness in mechanically ventilated patients: A randomized controlled trial.

Intensive care unit-acquired weakness (ICU-AW) is common in critically ill patients and increases the duration of mechanical ventilation (MV) and weaning time. Early mobilization, range of motion (ROM) exercises, and neuromuscular electrical stimulation (NMES) can prevent ICU-AW by maintaining muscle mass. However, studies highlighting the effects of combining NMES with early physical activity in ICU patients are limited. To evaluate the effect of NMES and early physical activity on ICU-AW in mechanically ventilated patients. A single-blinded randomized controlled trial was conducted in Alexandria, Egypt. Patients were randomly assigned to one of four groups: NMES, ROM, combined therapy (ROM + NMES), or conventional care (control group). The Medical Research Council (MRC) scale was used to assess the ICU-AW for the study patients over a 7-day period. The duration of the patient's MV and ICU stays were recorded. Of the 180 patients who were assessed for eligibility, 124 were randomly assigned to one of four groups: 32 patients in ROM exercises, 30 in NMES, 31 in combined therapy (ROM + NMES), and 31 in the control group. On day 7, ROM + NMES and NMES groups showed higher MRC scores than ROM and control groups (50.37 ± 2.34, 49.77 ± 2.19, 44.97 ± 3.61, and 41.10 ± 3.84, respectively). ANOVA test results indicated significant differences (p < .001) across the four groups. ICU-AW occurred in 0% of the ROM + NMES group, 60% of the ROM group, 13% of the NMES group, and 100% of the control group (p < .001). The MV duration (in days) in the ROM + NMES group was shorter (12.80 ± 3.800) than in the ROM, NMES, or control groups (21.80 ± 4.460, 18.73 ± 4.748, and 20.70 ± 3.932, respectively). ICU-LOS was shorter in the ROM + NMES group (17.43 ± 3.17 days) compared with the ROM group (22.53 ± 4.51 days), the NMES group (21.10 ± 5.0 days), and the control group (21.50 ± 4.42 days) with significant differences (p < .001) between the four groups. Daily sessions of NMES and early physical activity were well tolerated, preserved muscle strength, prevented ICU-AW, and decreased the duration of the MV and ICU stay. The findings of this study support the use of NMES and early physical exercises by critical care nurses as part of routine care for critically ill patients.

Anticoagulation-associated bleeding in patients randomised to screening for atrial fibrillation or usual care

Abstract Background Atrial fibrillation (AF) prevalence is rising, strongly aided by population ageing and increased awareness. Detection and treatment of subclinical AF may help mitigate stroke risk, but could increase iatrogenic complications. Purpose To evaluate whether detection of subclinical AF using implantable loop recorder (ILR) and subsequent initiation of oral anticoagulant (OAC) enhances the risk of major bleeding in elderly individuals with stroke risk factors. Methods This was a post-hoc analysis of a trial which randomised 6004 participants without known AF but with stroke risk factors in a 1:3 ratio to either ILR-screening for AF and OAC initiation upon AF episodes lasting ≥6 minutes or usual care (Control group). We examined the risk of major bleeding using OAC initiation as a time-varying exposure (figure 1) in Cox regression models, and similarly for the use of antiplatelets. Further, we estimated the incidence rates of OAC/antiplatelet initiation and discontinuation along with the distribution of major bleeding events according to drug exposure and subgroups. Results A total of 1019 participants (17%) initiated OAC; 578 (12.8%) in Control group vs. 441 (29.4%) in ILR group, with a mean age of 78.8 (±4.7) years in Control vs. 77.0 (±4.8) in ILR group, p&amp;lt;0.0001. Major bleeding events totalled 221 (3.7%) with 47 of these occurring after OAC initiation (4.6% of all OAC-users); 26 (4.5%) vs. 21 (4.8%) in Control and ILR group, respectively. Without the use of OAC or antiplatelets the overall rate of major bleeding was 0.44 (0.33-0.57) per 100-perosn years compared to 1.54 (1.13-2.05) after OAC initiation. For the individual person, the hazard ratio for major bleeding after OAC initiation was 2.08 (1.50-2.90) p&amp;lt;0.0001 compared to before initiation (Control: 2.81 (1.82-4.34) p&amp;lt;0.0001, ILR: 1.32 (0.78-2.23) p=0.31, p=0.07 for interaction)(table 1), similarly was usage of antiplatelet associated with a hazard ratio of 1.3 (0.96-1.75) p=0.09. For OAC users ≥75 years, the rate of major bleeding was 1.96 (1.30-2.83)(Control: 2.20 (1.23-3.63), ILR: 1.73 (0.92-2.96)), compared to 1.17 (0.70-1.83) among users &amp;lt;75 years (Control: 1.64 (0.82-2.93), ILR: 0.84 (0.36-1.66)). After OAC initiation, the discontinuation rate in the Control and ILR group was 9.60 (7.9-11.6) and 6.15 (4.95-7.55), respectively, while the rate of antiplatelet discontinuation was 7.44 (6.92-7.99) and 12.24 (10.9-13.4) in the Control and ILR group. Conclusion This post-hoc study of a randomised study found a two-fold risk increase of major bleeding after OAC initiation on individual basis compared with before, but this increase did not seem augmented by AF screening and treatment. A weaker signal was seen for antiplatelets. The OAC-associated bleeding risk was markedly higher in the elderly population. Finally, discontinuations of OAC and antiplatelets were common throughout follow-up.

An Accessible Pre-Rehabilitation Bundle for Patients Undergoing Elective Heart Valve Surgery with Limited Resources: The TIME Randomized Clinical Trial.

Despite gradually increasing evidence for pre-rehabilitation for heart valve surgery, it remains underused, especially in developing countries with limited resources. The study aimed to investigate the feasibility and effects of an innovative three-day pre-rehabilitation bundle for patients undergoing elective heart valve surgery. This was a single-center, assessor-blind, randomized clinical trial. A total of 165 patients were randomly assigned to either usual care (control group, n = 83) or usual care with an additional 3-day pre-rehabilitation bundle (Three-day of Inspiratory muscle training, aerobic Muscle training, and Education (TIME) group, n = 82). The main outcome of the study was the incidence of postoperative pulmonary complications (PPCs). Secondary outcomes included the feasibility of the intervention, duration of the non-invasive ventilator, length of stay, and PPCs-related medical costs on discharge. Of 165 patients 53.94% were male, the mean age was 63.41 years, and PPCs were present in 26 of 82 patients in the TIME group and 44 of 83 in the control group (odds ratio (OR), 0.60; 95% CI, 0.41-0.87, p = 0.006). The feasibility of the pre-rehabilitation bundle was good, and no adverse events were observed. Treatment satisfaction and motivation scored on 10-point scales, were 9.1 0.8 and 8.6 1.4, respectively. The TIME group also had fewer additional PPCs-related medical costs compared to the control group (6.96 vs. 9.57 thousand CNY (1.01 vs. 1.39 thousand USD), p 0.001). The three-day accessible pre-rehabilitation bundle reduces the incidence of PPCs, length of stay, and PPCs-related medical costs in patients undergoing elective valve surgery. It may provide an accessible model for the expansion of pre-rehabilitation in countries and regions with limited medical resources. This trial was based on the Consolidated Standards of Reporting Trials (CONSORT) guidelines. This trial was registered in the Chinese Clinical Trial Registry (identifier ChiCTR2000039671).