Differences In Change Scores Research Articles

The effects of a dyadic empowerment-based heart failure management (De-HF) programme on self-care and HRQL : a randomized controlled trial

Abstract Background The ever-growing epidemiology of heart failure (HF) and its detrimental impacts on patients’ quality of life and healthcare cost urge for effective interventions to ameliorate the modifiable prognostic factors. As substantial evidence suggests ineffective self-care as an important candidate especially for the post-discharge outcomes, various care approaches are developed to optimize this behavioral outcome. However, even family carers are heavily involved in the self-care process, dyadic approach to improve the health outcomes of both interactive partners are least applied in the HF transitional care model. Purpose To evaluate the effects of a dyadic empowerment-based heart failure management program (De-HF) on dyadic health and hospital service utilization outcomes. Methods This double-blind RCT randomized 88 HF patient-carer dyads to receive the De-HF program or a dialectic education program, after hospital discharge. Based on the Theory of Dyadic Illness Management, the 16-week De-HF Program, comprising i) a dyadic assessment, ii) five online empowerment modules and iii) follow-up telecare, integrated explicit strategies (scenario-based training, teach-back and goal-setting) to actively engage the care dyads in collaborative disease management. Figure 1 is the graphical presentation of the De-HF Program. The primary outcome is health-related quality of life (HRQL) of the care dyads. Secondary outcomes include patients’ self-care as well as shared care and perceived control of the dyad. Results The mean age of the HF patients was 76.8 (9.4). The patients were in moderate disease severity [NYHA II/II: 56/44%; mean LVEF = 42.5%]. Figure 2 shows the consort flow diagram. After adjusting the socio-demographic characteristic, two-way analysis of covariance showed that patients in the De-HF program showed significantly greater improvement in patients’ self-care domains [Mean difference in change of score (95% CI): Self-care maintenance = 7.15 (1.82-12.46),Cohen’s d = 0.26, p=0.009; Self-care management = 10.04(3.29-16.79), Cohen’s d=0.65, p=0.004; symptom perception = 15.59 (8.20-22.98), Cohen’s d=0.928, p<0.001] and Minnesota Living with Heart Failure score [Mean different in the change of score (95% CI) = -11.45 (-18.24 - -4.66). Cohen’s d = -0.742, p=0.001]. The patient-carer dyads also have significantly greater improvement in perceived control (p=0.001) and collaborative disease management in terms of joint decision-making (p=0.001) and sense of reciprocity (p=0.026). Conclusion Dyadic science has evolved in self-care research for HF. This trial provides the first evidence to inform the positive effects of a theory-based dyadic transitional care program in improving the collaborative self-care management in a family context and patient health outcome. Longer-term evaluation on the effects of De-HF program on health service utilization outcomes and cost-effectiveness will be followed.The De-HF Managment ProgramThe Consort Flow Diagram

Efficacy of ensitrelvir for cough due to COVID-19 Omicron variant in medical healthcare workers.

We evaluated the efficacy of ensitrelvir for the treatment of cough due to coronavirus disease 2019 Omicron variant in medical healthcare workers. A total of 633 patients were registered in this study: 206 patients chose ensitrelvir and 427 patients chose symptomatic treatment. Difference in score changes using the Leicester Cough Questionnaire between groups was 3.17 on day 4, 3.24 on day 7, and 2.46 on day 14. The analysis demonstrated a significant difference at all time points.

Measurement properties of the Spanish COPM in older adult rehabilitation inpatients

Aims To analyse the measurement properties of the Spanish version of the COPM (Canadian Occupational Performance Measure) in older adult rehabilitation inpatients. Method A sample of 172 users from 17 inpatient care facilities for older adults (47% nursing homes) participated in a quantitative prospective study. We examined validity by correlating the COPM with the Barthel Index (BI), the Lawton Instrumental Activities of Daily Living scale (IADL), the EuroQol-five domains-three level questionnaire (EQ-5D-3L), and the Client-Centred Rehabilitation Questionnaire (CCRQ) and by examining associations with demographic variables. Reliability was evaluated through test-retest and responsiveness through differences in change scores in two types of care facilities. Results Participants prioritised 637 occupational performance problems, mainly in the area of self-care (70.5%). The COPM scale scores were significantly correlated with BI, IADL, EQ-5D-3L (except the pain dimension), and CCRQ (except the family involvement and continuity dimensions). COPM scores did not show statistically significant differences concerning educational level. Regarding reliability, high test-retest correlations were obtained (>.80). Nursing home users showed less responsiveness to rehabilitation than other users (change score < 2 vs. > 2 points). Conclusion and significance The Spanish COPM provides satisfactory measurement properties as a client-centred instrument in older adult rehabilitation inpatient.

The effect of robot-assisted versus standard training on motor function following subacute rehabilitation after ischemic stroke – protocol for a randomised controlled trial nested in a prospective cohort (RoboRehab)

BackgroundBody weight unloaded treadmill training has shown limited efficacy in further improving functional capacity after subacute rehabilitation of ischemic stroke patients. Dynamic robot assisted bodyweight unloading is a novel technology that may provide superior training stimuli and continued functional improvements in individuals with residual impairments in the chronic phase after the ischemic insult. The aim of the present study is to investigate the effect of dynamic robot-assisted versus standard training, initiated 6 months post-stroke, on motor function, physical function, fatigue, and quality of life in stroke-affected individuals still suffering from moderate-to-severe disabilities after subacute rehabilitation.MethodsStroke-affected individuals with moderate to severe disabilities will be recruited into a prospective cohort with measurements at 3-, 6-, 12- and 18-months post-stroke. A randomised controlled trial (RCT) will be nested in the prospective cohort with measurements pre-intervention (Pre), post-intervention (Post) and at follow-up 6 months following post-intervention testing. The present RCT will be conducted as a multicentre parallel-group superiority of intervention study with assessor-blinding and a stratified block randomisation design. Following pre-intervention testing, participants in the RCT study will be randomised into robot-assisted training (intervention) or standard training (active control). Participants in both groups will train 1:1 with a physiotherapist two times a week for 6 months (groups are matched for time allocated to training). The primary outcome is the between-group difference in change score of Fugl-Meyer Lower Extremity Assessment from pre-post intervention on the intention-to-treat population. A per-protocol analysis will be conducted analysing the differences in change scores of the participants demonstrating acceptable adherence. A priori sample size calculation allowing the detection of the minimally clinically important between-group difference of 6 points in the primary outcome (standard deviation 6 point, α = 5% and β = 80%) resulted in 34 study participants. Allowing for dropout the study will include 40 participants in total.DiscussionFor stroke-affected individuals still suffering from moderate to severe disabilities following subacute standard rehabilitation, training interventions based on dynamic robot-assisted body weight unloading may facilitate an appropriate intensity, volume and task-specificity in training leading to superior functional recovery compared to training without the use of body weight unloading.Trial RegistrationClinicalTrials.gov. NCT06273475.Trial status: Recruiting.Trial identifier: NCT06273475.Registry name: ClinicalTrials.gov.Date of registration on ClinicalTrials.gov: 22/02/2024.

Poster 127: Repairs of Isolated Supraspinatus Tears: Single vs. Double Row Repairs Effect on Patient-Reported Outcomes Over a 2-Year Episode of Care

Objectives: Rotator cuff tears are the most common cause of shoulder disability, most commonly affecting the middle-aged population. Treatment for rotator cuff tears has changed dramatically over the past few decades, with overall volume of rotator cuff repairs (RCRs) increasing by approximately 1.6% each year. Simultaneously, there has been a shift from open, inpatient RCR to arthroscopic, outpatient procedures. Currently, well over 75% of patients undergo arthroscopic repair. The two most common techniques for rotator cuff fixation include single- or double-row fixation. Cadaveric and biomechanical studies demonstrate more complete reduction of the rotator cuff to its original footprint with double row repair, with a subsequent increase in anatomic restoration and biomechanical advantage. Many studies regarding clinical and functional outcomes, however, have not consistently demonstrated statistically significant differences between the two. The purpose of this study is to determine differences in patient-reported outcomes (PROs) after single- and double-row rotator cuff repairs at one and two years postoperatively. We hypothesize that single-row RCR will have noninferior clinical and patient-reported outcomes when compared to the double-row RCR cohort over the 2-year episode of care. Primary outcomes include baseline, 1-year and 2-year postoperative Single Assessment Numeric Evaluation (SANE) scores. Methods: All patients within a single health system that underwent primary rotator cuff repair between 2016 and 2022 were eligible for inclusion in this study. Exclusion criteria included incomplete baseline PROs, involvement of infraspinatus, subscapularis or teres minor tendons, revision surgeries, and concomitant fractures of the shoulder. Demographic information including age, sex, BMI, ASA score, injury characteristics and medical comorbidities were obtained through review of the patients’ electronic medical record. Surgical characteristics and technique were obtained from operative notes. PROs were collected prospectively and stored in a HIPAA-compliant electronic database until retrospective review for this study. Primary outcomes of interest include SANE score at baseline, 1-year and 2-years postoperatively. Secondary outcomes of interest included American Shoulder and Elbow Surgeons (ASES) scores, Patient-Reported Outcomes Measurement Information System (PROMIS) global 10 health questionnaire scores, rates of symptomatic retear and reoperation. Statistical analysis included descriptive analyses, paired t-tests, chi-squared test of independence and one-way ANOVA as appropriate. Statistical significance was defined as an alpha value of p ≤ 0.05. Results: A total of 237 patients met criteria for inclusion in this study, the majority of which were female (122, 51.5%). The average BMI was 30.0 ± 5.6, and the average age of the study participants was 59.0 ± 9.4 years. The majority of patients underwent double-row RCR (134, 56.5%). There were no significant differences in age, BMI, ASA score, gender, or smoking status between the two groups (Table 1). There was a higher observed frequency of diabetes mellitus than expected in the double-row cohort, however this did not reach statistical significance (p = 0.066). There was no significant difference in symptomatic retear, revision RCR, and other reoperation rates between the two cohorts (Table 2). The cohort that received double-row repair had a higher observed frequency of full-thickness tears than expected (p &lt;0.001), however there was no significant difference in the observed frequencies of chronic and acute tears between the two cohorts. Baseline ASES scores did not differ significantly between the two cohorts (p = 0.505). Both cohorts saw statistically significant increase in ASES scores from baseline to 1-year (Figure 1). The difference between 1-year and 2-year ASES scores was less than a quarter of the improvement seen in the first year postoperatively, however, was still statistically significant in the double-row cohort and neared statistical significance in the single-row cohort (p = 0.048 and p = 0.075, respectively). While both cohorts saw significant improvement in ASES scores over the 2-year period, there was no significant difference in score change between the two cohorts. The baseline SANE scores were 40.7 ± 20.6 and 43.2 ± 21.4 for the double and single-row cohorts respectively. Each cohort saw statistically significant increases in SANE scores at 1 year postoperatively and continued to see significant increase between 1- and 2-years postoperatively (Figure 1). There was no statistically significant difference between the two cohorts regarding 1- and 2-year change in SANE scores. Conclusions: Over a 2-year period of care after RCR, patients saw significant improvement in SANE and ASES scores, with the majority occurring in the first year postoperatively. There were no statistically significant differences in patient-reported outcomes between patients that underwent double- and single-row repairs. Single- and double-row RCRs perform comparably over a 2-year episode of care, with excellent clinical and patient-reported outcomes. [Figure: see text]

Supporting Caregivers of Hemodialysis Patients: Applying the 5-A Self-management Model to Alleviate Caregiver Burden

Background: Enduring chronic renal failure and undergoing hemodialysis significantly impact patients' and their caregivers' physical, spiritual, psychological, and functional abilities. Objectives: To examine the impact of implementing the 5-A self-management model on the burden experienced by caregivers of patients undergoing hemodialysis. Methods: This experimental study, utilizing a pre-test and post-test design, involved 90 caregivers of patients undergoing hemodialysis. Caregivers were selected through simple random sampling. Data were collected using a demographic questionnaire and the ZARIT caregiving burden tool. The intervention included implementing the 5-A Self-Management model. Data analysis involved repeated measures ANOVA, comparing scores before the intervention, immediately after, as well as one and three months later. Results: Prior to the intervention, caregivers in the intervention group experienced higher levels of pressure compared to the control group (P = 0.018). However, one month (P = 0.004) and three months (P = 0.003) after the intervention, the intervention group's scores were significantly lower than those of the control group. Furthermore, the effect of time (P &lt; 0.001) and the interaction effect (P &lt; 0.001) were statistically significant, indicating the intervention's positive impact on caregivers' burden and the differences in score changes over time. Conclusions: Implementation of the 5-A self-management model led to a significant reduction in the burden of caregiving among caregivers of patients undergoing hemodialysis. Providing self-management training tailored to the needs of hemodialysis patients and their caregivers is an effective approach to enhancing caregivers' abilities.

Comparing effectiveness of residential versus intensive virtual treatment for veterans with posttraumatic stress disorder.

During the COVID-19 pandemic, restrictions imposed on residential treatment programs necessitated rapid implementation of virtual treatment delivery. Posttraumatic stress disorder (PTSD) Residential Rehabilitation Treatment Programs (P-RRTP) are a key mental health treatment for Veterans with PTSD who require more intensive interventions than outpatient care. During the pandemic, the W. G. (Bill) Hefner VA Healthcare System developed and implemented a Virtual Intensive Outpatient Program for PTSD (VIOPP) to meet the needs of the Veteran population. The purpose of this analysis was to compare the effectiveness of VIOPP to P-RRTP. Analyses included N = 370 Veterans, n = 193 who completed P-RRTP between January 2018 to April 2020 and n = 177 who completed VIOPP between June 2020 and November 2022 and provided pre- and posttreatment scores. Pre- and posttreatment scores of the PTSD Checklist for DSM-5 (PCL-5) were available for all patients. Pre- and posttreatment depressive symptom scores from the Nine-item Patient Health Questionnaire (PHQ-9) were available for n = 254 Veterans. Paired and independent samples t tests evaluated differences in change scores overall and by treatment modality (residential vs. virtual). Results indicated a significant decrease in PCL-5 scores regardless of treatment modality, p < .001. Despite beginning VIOPP with significantly higher PCL-5 scores than P-RRTP, there were no significant differences in PCL-5 change scores between virtual (M = -16.94) and residential treatment (M = -17.10), p = .910. PHQ-9 scores also decreased significantly for both treatment groups. These analyses suggest that intensive virtual treatment has similar effectiveness to residential treatment for PTSD. This supports the development of intensive virtual interventions as viable alternatives to residential treatments and a valuable component within the continuum of PTSD care. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Optimizing smartphone psychotherapy for depressive symptoms in patients with cancer: Multiphase optimization strategy using a decentralized multicenter randomized clinical trial (J-SUPPORT 2001 Study).

Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. This was a decentralized, parallel-group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive-behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem-solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire-9 (PHQ-9) total score between baseline and week 8. Secondary outcomes included anxiety. In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ-9 total score was significantly reduced from baseline for all participants by -1.41 points (95% confidence interval [CI] -1.89, -0.92), but between-group differences in change scores were not significant (BA: -0.04, 95% CI -0.75, 0.67; AT: -0.16, 95% CI -0.87, 0.55; PS: -0.19, 95% CI -0.90, 0.52). As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence-based recommendations regarding the use of specific smartphone psychotherapy.

The effect of Tai Chi lower extremity exercise on the balance control of older adults in assistant living communities

BackgroundAlthough Tai Chi (TC) is an evidence-based fall prevention training for older adults, its effective movements remain unclear, which may limit the practice of TC. The purpose of this study was to compare the effectiveness of TC lower extremity exercise (TC LEE), the 8-form Tai Chi (8-form TC), and a stretching control intervention for improving balance and functional mobility among older adults.MethodsThis was a randomized controlled trial. A total of 102 participants (79 ± 6 years old) were recruited from assisted living facilities. All participants were randomly assigned to the TC LEE (n = 40), 8-form TC (n = 31), and stretching (n = 31) groups in which they received the respective interventions for 16 weeks. The Berg Balance Scale (BBS), Timed Up and Go (TUG) test, and center of pressure (COP) measurements during quiet stance were collected prior to and following the 16-week interventions. Comparisons on all measurements were conducted among all groups.ResultsSignificant improvements were found in BBS (P = 0.002), TUG test (P = 0.001), root mean square amplitude of COP displacement in the anterior–posterior (P = 0.001) and medial–lateral (P = 0.001) directions, and average COP speed in the anterior–posterior (P = 0.001) and medial–lateral (P = 0.001) directions after training in the TC intervention groups compared with the stretching group. The upper limit of the 95% confidence interval (CI) of differences in change scores on the BBS (-0.8 – 1.3 points) between the TC LEE group and the 8-form TC group was within equivalence margins (1.8 points), while the upper limit of the 95% CI of differences in change scores on the TUG test (0.1 – 2.1 s) exceeded the equivalence margin (0.7 s) with the TC LEE group having the larger change scores.ConclusionTC LEE can improve balance and functional mobility in older adults, and may have greater effect than the 8-form TC on improving functional mobility as measured by the TUG test.Trial registrationChiCTR2300070600 retrospectively registered.

A pilot randomized controlled trial of online written exposure therapy delivered by peer coaches to veterans with posttraumatic stress disorder.

This pilot randomized clinical trial (RCT) sought to examine the preliminary efficacy of an internet-based version of written exposure therapy delivered to veterans through an online program supported by peer coaches. Veterans (N = 124) with clinically significant posttraumatic stress disorder (PTSD) symptoms were randomly assigned to imaginal exposure either via writing (written exposure) or verbal recounting (verbal exposure). The online treatment involved four to eight sessions of imaginal exposure preceded and followed by an online chat with a peer coach. Participants completed assessments at baseline, posttreatment, and 3-month follow-up. Half of the participants never started treatment; among those who started treatment, the mean number of sessions completed was 4.92. At posttreatment, participants in both conditions reported clinically meaningful improvements in PTSD symptoms, d = 1.35; depressive symptoms, d = 1.10; and functioning, d = 0.39. Although participants in both treatment conditions demonstrated significant improvements in PTSD symptom severity, equivalence results were inconclusive, as the 95% confidence interval of the change score difference exceeded the specified margin and overlapped with 0. Estimated mean change scores demonstrated that both conditions showed significant reductions at posttreatment and follow-up. Although engagement with the online program was a significant challenge, the findings suggest that written exposure therapy is effective for improving PTSD symptoms, depressive symptoms, and functioning when adapted for internet-based delivery and facilitated by peer coaches. Using technology to deliver exposure therapy and task-shifting the role of the therapist to peer coaches are promising strategies to increase access to effective PTSD care.

Assessment of Exercise Capacity in Home Healthcare: Differences in Three Self-Paced Tests.

Submaximal functional tests of endurance are ubiquitous in clinical practice. This investigation compared cardiovascular responses, perceived exertion, and performance measures following the completion of three self-paced, 2-minute, functional tests of endurance. A pilot prospective, observational, cross-sectional design with 16 community-dwelling older participants compared heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), rating of perceived exertion (RPE), and performance measures following the completion of three randomly allocated self-paced activities. The three activities included 2 minutes of stepping in standing (2MSTD), 2 minutes of seated stepping (2MSIT), and a 2-minute walk test (2MWT). A within-subjects repeated measures ANOVA analyzed differences in change scores for cardiovascular and RPE responses. Pearson's correlations assessed associations in performance measures between the three tests. Standing stepping compared to seated stepping produced statistically higher change scores in HR, SBP, DBP, and RPE (p < .05). Further, 2MSTD revealed statistically higher SBP and RPE scores compared to 2MWT (p < .05). Large and moderate correlations were observed between number of steps completed in sitting and standing (r = 0.83, p < .01) and between standing steps and distance walked (r = 0.56, p = .02), respectively. This pilot investigation informs home care physical therapists that 2 minutes of self-paced stepping in standing produced the greatest change scores in all cardiovascular and perceived exertion responses. No significant differences were noted in HR between self-paced walking and standing stepping, and between standing and seated stepping. For patients unable to walk or step in standing, self-paced seated stepping may be a viable alternative.

Do patients with lumbar spinal stenosis benefit from decompression of levels with adjacent moderate stenosis? A prospective cohort study from the NORDSTEN study

BackgroundLumbar spinal stenosis (LSS) is characterized by pain that radiates to the buttocks and/or legs, aggravated by walking and relieved by forward flexion. There is poor correlation between clinical symptoms and severity of stenosis on MRI, and multilevel stenosis has not been described to present worse symptoms or treatment outcomes, compared with patients with single-level stenosis. In patients with one level with severe stenosis combined with an adjacent level with moderate stenosis, the surgeon must decide whether to decompress only the narrowest level or both, to achieve the best possible outcome. The potential benefits of performing surgery on an adjacent moderate stenosis is debated, and the scientific evidence in scarce. PurposeThe aim of the present study was to investigate whether patients with a level of adjacent moderate stenosis, along with an index stenosis, benefitted from a dual-level decompression (DLD) compared with a single-level decompression (SLD). Furthermore, to investigate whether DLD patients had longer duration of surgery and hospital stay, higher rates of complications and/or lower rate of reoperations compared with SLD patients. Study designProspective cohort study. Patient sampleWe analyzed data from the Norwegian Degenerative Spondylisthesis and Spinal Stenosis study- Spinal Stenosis Trial (NORDSTEN-SST). In this randomized multicenter study, 437 patients were included, evaluating clinical outcomes of three different surgical treatment options for LSS. Patients with degenerative spondylolisthesis were excluded. MethodBased on preoperative MRI, the present analysis included all patients who had a moderate stenosis (defined as Schizas B or C) in addition to a predefined index stenosis (the level with the smallest cross-sectional area). We compared patients who, based on the surgeons` choice, received a dual-level decompression, with those receiving a single-level decompression. Outcome measuresThe primary outcome was mean change in the Oswestry Disability Index (ODI) score from baseline to 2-year follow up. Secondary outcomes were proportion of success (30% reduction in ODI score), the Numeric Rating Scales for back and leg pain (NRS), the EuroQol 5-dimensional questionnaire utility index (EQ-5D), the Zurich Claudication Questionnaire (ZCQ), the Global Perceived Effect (GPE)-scale, duration of surgery, duration of hospital stay, perioperative complications and reoperation rates. ResultsAmong the 222 patients, included in the analysis, 108 underwent DLD and 114 underwent SLD. There was no difference in change scores for any of the investigated patient-reported outcomes between the groups after 2 years. However, the DLD group had longer duration of surgery and longer length of hospital stay. There was no difference in reoperation rates or perioperative complications. ConclusionThis study, alongside the NORDSTEN-LSS trial on patients with adjacent moderate stenosis as well as an index stenosis, showed no superior clinical effectiveness for dual-level surgery compared with single-level surgery.

Neurostimulation for Advanced Parkinson Disease and Quality of Life at 5 Years

Deep brain stimulation of the subthalamic nucleus (STN-DBS) improves quality of life (QOL) in patients with advanced Parkinson disease (PD). However, controlled studies with more than 3 years of follow-up are lacking. To investigate the long-term effects of STN-DBS on QOL compared with standard-of-care medication (MED). In this prospective, observational, quasi-experimental, longitudinal nonrandomized controlled trial, 183 patients were screened for eligibility and 167 were enrolled from March 1, 2011, to May 31, 2017, at 3 European university centers. Propensity score matching for demographic and clinical characteristics was applied to 108 patients with PD (62 in the STN-DBS group and 46 in the MED group), resulting in a well-balanced, matched subcohort of 25 patients per group. Data analysis was performed from September 2022 to January 2023. Treatment for PD of STN-DBS or MED. Assessments included Parkinson's Disease Questionnaire 8 (PDQ-8), Unified PD Rating Scale-motor examination, Scales for Outcomes in PD-activities of daily living (ADL) and motor complications, and levodopa-equivalent daily dose. Within-group longitudinal outcome changes, between-group differences, and correlations of change scores were analyzed. The study population in the analysis included 108 patients (mean [SD] age, 63.7 [8.3] years; 66 [61.1%] male). At 5-year follow-up, PDQ-8 and ADL worsened only in the MED group (PDQ-8 change, -10.9; 95% CI, -19.0 to -2.7; P = .01; ADL change: -2.0; 95% CI, -3.1 to -0.8; P = .002), whereas both outcomes remained stable in the STN-DBS group (PDQ-8 change, -4.3; 95% CI, -13.2 to 4.7; P = .34; ADL change, -0.8; 95% CI, -2.5 to 1.0; P = .38). Changes in PDQ-8 and ADL correlated moderately (rs = .40, P = .008). Furthermore, STN-DBS outcomes were favorable for motor complications (median difference in change scores between STN-DBS and MED, -2.0; 95% CI, -4.0 to -1.0; P = .003), mobility (-1.0; 95% CI, -2.0 to 0; P = .03), and levodopa-equivalent daily dose reduction (-821.4; 95% CI, -1111.9 to -530.8; P < .001). This study provides evidence of differences in QOL outcomes at 5-year follow-up between STN-DBS (stable) and MED (worsened), mainly driven by the favorable effect of STN-DBS on mobility (class IIb evidence). The association between changes in QOL and ADL, but not motor impairment or complications, highlights the relative importance of ADL outcomes for long-term DBS assessments. German ClinicalTrials Registry: DRKS00006735.

Efficacy and Health-Related Quality of Life Impact of Fecal Microbiota, Live-jslm: A Post Hoc Analysis of PUNCH CD3 Patients at First Recurrence of Clostridioides difficile Infection.

Clostridioides difficile infection (CDI) causes symptoms of varying severity and negatively impacts patients' health-related quality of life (HRQL). Despite antibiotic treatment, recurrence of CDI (rCDI) is common and imposes clinical and economic burdens on patients. Fecal microbiota, live-jslm (REBYOTA [RBL]) is newly approved in the USA for prevention of rCDI following antibiotic treatments. We analyzed efficacy and HRQL impact of RBL vs. placebo in patients at first rCDI using data from the phase3 randomized, double-blind placebo-controlled clinical trial, PUNCH CD3. This post hoc analysis included patients at first rCDI fromPUNCH CD3. Treatment success (i.e., absence of diarrhea within 8weeks post-treatment) was analyzed adjusting for baseline patient characteristics. HRQL was measured using the Clostridioides difficile Quality of Life Survey (Cdiff32); absolute scores and change from baseline in total and domain (physical, mental, and social) scores were summarized and compared between arms. Analyses were conducted for the trial's blinded phase only. Among 86 eligible patients (32.8% of the overall trial population, RBL 53 [61.6%], placebo 33 [38.4%]), RBL-treated patients had significantly lower odds of recurrence (i.e., greater probability of treatment success) at week8 vs. placebo (odds ratio 0.35 [95% confidence interval 0.13, 0.98]). Probability of treatment success at week8 was 81% for RBL and 60% for placebo, representing 21% absolute and 35% relative increases for RBL (crude proportions 79.2% vs. 60.6%; relative risk 0.53, p = 0.06). Additionally, RBL was associated with significantly higher Cdiff32 total (change score difference 13.5 [standard deviation 5.7], p < 0.05) and mental domain (16.2 [6.0], p < 0.01) scores vs. placebo from baseline to week8. Compared to placebo, RBL demonstrated a significantly higher treatment success in preventing further rCDI and enhanced HRQL among patients at first recurrence, establishing RBL as an effective treatment to prevent further recurrences in these patients. ClinicalTrials.gov Identifier NCT03244644.

Examining longitudinal changes of disease severity scores in familial forms of frontotemporal dementia within the GENFI cohort

AbstractBackgroundThe CDR®+NACC FTLD Sum of Boxes (SB) score is a well‐established measure of disease severity in frontotemporal dementia (FTD), however, few studies have assessed longitudinal changes in score within familial forms of FTD.Method343 participants from the Genetic FTD Initiative (77 mutation‐negative controls, 109 C9orf72 expansion carriers, 105 GRN mutation carriers, and 52 MAPT mutation carriers), with available scores on the CDR®+NACC FTLD‐SB and the FTD Rating Scale (FRS) at baseline and follow‐up, were examined. Using the baseline FRS percentage scores, mutation carriers were stratified into four groups: asymptomatic/very mild (100‐97%), mild (96‐80%), moderate (79‐41%), and severe (40‐0%). Linear regression models with bootstrapping were used to assess annualised change in CDR®+NACC FTLD‐SB scores across genetic groups between participants' first and follow‐up visit.Result C9orf72 and GRN mutation carriers in the moderate and severe groups, as well as mild GRN carriers, showed significantly greater change than controls (p &lt; 0.050). No significant differences in change scores were observed between MAPT mutation carriers and controls. Comparisons within genetic groups revealed that both the moderate and severe GRN and C9orf72 expansion carriers showed larger annualised change relative to their asymptomatic/very mild counterparts (p &lt; 0.001 and p = 0.037; p = 0.028 and p &lt; 0.001, respectively). The moderate GRN and severe C9orf72 groups also demonstrated greater annualised score changes than their respective mild counterparts (p &lt; .001; p = 0.001). For MAPT mutation carriers, no significant changes were observed. Between genetic group comparisons revealed significant change score differences between the moderate individuals, with GRN mutation carriers showing a greater change than the C9orf72 and MAPT groups (both p &lt; 0.001), and the C9orf72 group showing a larger annualised change than the MAPT mutation carriers (p = 0.041).ConclusionThe CDR®+NACC FTLD‐SB detects significant changes in disease severity from baseline to a first follow‐up visit in familial forms of FTD, with GRN mutation carriers showing the greatest annualised change.

The effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomized trial

IntroductionRestricted ankle dorsiflexion is common after lower limb injury. The aim of this pilot study was to investigate the effect of passive ankle joint mobilization and calf muscle massage on ankle dorsiflexion range of motion in adults with residual restricted dorsiflexion. The secondary aim was to assess the methodology of the pilot study to inform a larger clinical trial. MethodThe study design was a randomized crossover trial with assessor blinding. Twenty-five healthy participants with a history of lower limb injury were included in the study. Ankle joint mobilization and calf muscle massage were applied for 5 min in a random order, one to two weeks apart. Ankle dorsiflexion was measured by using the weight-bearing lunge pre- and post-intervention (cm). Paired t-tests were used to analyze the effect of the manual therapy interventions on restricted ankles. A minimal detectable difference 95% (MMD95) was calculated. The pilot study was analyzed for suitability of inclusion criteria, blinding of assessors and the manual therapist, and the washout period. ResultsA significant increase in dorsiflexion was demonstrated for ankle joint mobilization (change score = 0.51 ± 0.76, p = 0.003) and calf muscle soft tissue massage (change score = 0.91 ± 1.07, p < 0.001). There was no difference in change scores between manual therapy techniques (mobilization 0.51 ± 0.76, massage 0.91 ± 1.07, p = 0.12). Evaluation of the pilot study revealed limitations to be modified in future studies. ConclusionThese preliminary data indicate ankle joint mobilization and calf muscle soft tissue massage had similar effects on increasing ankle dorsiflexion range of motion in ankles with residual dorsiflexion restriction.

Sustained Effect of Simulation-Based Resuscitation Education on Knowledge, Self-Confidence, and Performance Ability of Neonatal Intensive Care Unit Nurses.

Simulation education is essential for the development of nurses' practical skills. This study evaluated the impact and duration of simulation-based neonatal resuscitation education on the knowledge, self-confidence, and performance ability of neonatal intensive care unit (NICU) nurses. This quasi-experimental study was conducted in South Korea and included 35 NICU nurses working in tertiary hospitals between August and October 2021. Simulation-based neonatal resuscitation education (NRE) was provided for 80 minutes, and its effectiveness was measured in terms of nurses' knowledge, self-confidence, and performance ability. Data collection was conducted before, 1 week after, 3 weeks after, and 5 weeks after the training, and the collected data were calculated and analyzed using a t test and repeated measures analysis of variance. Simulation-based NRE improved knowledge, self-confidence, and performance in neonatal resuscitation. Performance ability showed greater improvement than knowledge or self-confidence, and all three areas showed significant differences in score changes over time. The duration of the training effect should be considered an important factor. [J Contin Educ Nurs. 2024;55(2):79-86.].

Impact of interactive teaching models in tourism management degree on measures of student depression

BackgroundThe prevalence and impact of depression among college students have become an important issue requiring innovative interventions. To address this challenge, this paper proposes an interactive teaching model for tourism management degrees as a strategy to alleviate depression among students. This interactive teaching model provides an active, engaging and meaningful learning experience. This model aims to help students reduce symptoms of depression through the design and implementation of the Tourism Management degree programmer.Subjects and MethodsThe non-randomized controlled study involved students enrolled in Tourism Management courses, selected based on the criteria of demonstrated depressive symptoms. Depression levels were measured using the Stanford Acute Stress Response Questionnaire (SASRQ) and the 3-min Confusion Assessment Scale (3D-CAM). The acquired data were analyzed using the SPSS 23.0 statistical package.ResultsStudents exposed to the interactive teaching mode showed a significant decrease in SASRQ and 3D-CAM scores, and there was a significant difference in score changes compared to students who received the traditional teaching mode (P&lt;0.05). It is worth noting that the interactive teaching group has a higher level of classroom participation and subjective well-being.ConclusionsThe use of interactive teaching models in Tourism Management courses demonstrates promising effectiveness in alleviating student depression. This innovative approach could be vital for mental health promotion in universities, potentially transforming educational pedagogy.

Editor's Choice – Quality of Life after Stenting for Iliofemoral Venous Obstruction: A Randomised Controlled Trial with One Year Follow Up

Deep venous obstruction (DVO) is a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO. Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in score changes for EuroQoL 5-Dimension 5 Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score. After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n= 42) or control group (n= 21). Overall, 50patients had available data for primary outcome analysis. The adjusted mean difference between 12month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p= .026), respectively, in favour of the stent group. The differences were significant, but a pre-defined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p= .040), -11.83 (95% CI -20.81 - 2.86, p= .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p= .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p= .17) for the Villalta score. Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points. NCT03026049.

Women achieve equivalent health-related quality of life benefits to men from attending cardiac rehabilitation: a matched case-control study

Abstract Funding Acknowledgements Type of funding sources: Public grant(s) – National budget only. Main funding source(s): SOLVE-CHD NHMRC Synergy Grant Background/Introduction Coronary heart disease (CHD) is the leading cause of death in women globally; and women have worse health outcomes from CHD than men, including poorer health-related quality of life (HRQL). Comprehensive cardiac rehabilitation (EBCR) has well-established benefit for patients with CHD in improving HRQL. These benefits have rarely been distinguished separately for women despite known differences to men. Purpose The aim of this study was to compare women and men’s HRQL outcomes after accounting for differences in age, partnership status and diagnosis. Methods A secondary analysis of a larger prospective observational study of CR outcomes using a matched case-control study of women and men. The sample included patients enrolled in four CR programs following admission for CHD (myocardial infarction [MI], percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]). Women were matched to men based on age (within 0-2 years), marital status (single, or partnered), and diagnosis (MI, PCI, or CABG). Sociodemographic data were collected from the participants and clinical information (diagnosis, comorbidities) from the medical record. HRQL was measured using the Short Form-12 Health Survey (SF-12). Results Thirty-seven matched women and men were included in this study at baseline, of whom 27 completed the study (72.9%). There were no significance differences in sociodemographic and clinical characteristics between men and women at baseline. Both women and men improved HRQL substantially from pre-post CR, with no significant differences in change scores in any domain between the sexes despite women having worse scores at baseline in Physical Functioning (mean score 41.59 vs 44.15), Bodily Pain (mean score 47.78 vs 48.71) and overall physical summary score (mean score 44.14 vs 45.29). Women had clinically meaningful improvements in Physical Functioning (MD 6.51, 95% CI 2.59-10.44) and Role Physical (MD 6.42, 95% CI 2.81-10.03), Mental Health (MD 4.35, 95% CI 2.05-6.66) and Bodily Pain (MD 4.97, 95% CI 1.36-8.60) and in the overall physical summary score (MD 5.67, 95% CI 1.98-9.38). Men achieved clinically meaningful improvements in the same domains as women plus Vitality (MD 5.11, 95% CI 0.87-9.36) and Social Function (MD 8.54, 95% CI 3.98-13.09). Conclusion(s) When matched to men for age, partnership status, and diagnosis, women achieve clinically meaningful and equivalent HRQL outcomes following CR. Women significantly improved in overall physical and mental health HRQL, as well as in the majority of HRQL domains. These findings could be used to strengthen advocacy in supporting women with CHD to participate and complete CR programs.