Between-group Differences Research Articles

Reward processing in young people with self-harm behaviour

Twenty percent of young people report a lifetime presence of self-harm (SH) behaviour, associated with negative health and functional outcomes. Understanding the underlying cognitive mechanisms is needed to develop targeted early interventions. Reward processing biases may underlie SH, aligning with accounts of the behaviour acquiring “addictive” characteristics. However, the specific nature of such biases remains unclear, particularly its relationship with negative affect (NA) that frequently triggers SH. In Study 1, we compared young people (aged 16–25) with SH to a group with NA but no SH history and a healthy control group on performance of a novel Incentive Delay Task (IDT), with SH-related (SH trials), positive social (social trials) or monetary images (money trials) as stimuli. In Study 2, a different sample of SH and HC participants completed the same IDT following NA induction via an online Trier Social Stress Test. For both studies, we hypothesised faster and more correct responses in the SH group than control groups on SH trials. Contradicting our hypothesis, there were no significant between-group differences in IDT performance on SH, social and money trials in either study. Certain SH characteristics (positive reinforcement, SH mental imagery, urge) were significantly correlated with better performance on SH trials in SH participants. Thus, broadly SH behaviour may not be underpinned by motivational biases towards SH-related cues or naturalistic rewards. Future studies should clarify whether incentivisation of SH-related cues instead explains individual differences in SH behaviour and its relation with treatment and prognosis.

Using nonlinear dynamics analysis to evaluate time response of cupping therapy with different intervention timings on reducing muscle fatigue.

Cupping therapy has been indicated effective in reducing muscle fatigue after 24h based on the spectral analyses of surface electromyography (sEMG). However, there is no sufficient evidence showing changes of sEMG nonlinear indexes at more time points after cupping therapy. Furthermore, it is unclear whether the intervention timings of cupping therapy affect the recovery from muscle fatigue. The purpose of this study was to use the sEMG nonlinear analysis to assess the difference of time response of cupping therapy between different intervention timings after muscle fatigue. This randomized controlled trial recruited 26 healthy volunteers. Cupping therapy (-300mmHg pressure for 5min by the 45mm-diameter cup) was applied before (i.e., pre-condition) or after (i.e., post-condition) muscle fatigue induced by performing repeated biceps curls at 75% of the 10 repetitions of maximum (RM) on the non-dominant upper extremity. Subjects were randomly allocated to the pre-condition group or the post-condition group. The sEMG signals during the maximal voluntary isometric contractions (MVC) of the biceps were recorded at four time points (i.e., baseline; post 1: immediate after cupping-fatigue/fatigue-cupping interventions; post 2: 3h after cupping-fatigue/fatigue-cupping interventions; post 3: 6h after cupping-fatigue/fatigue-cupping interventions). Two nonlinear sEMG indexes (sample entropy, SampEn; and percent determinism based on recurrence quantification analysis, %DET) were used to evaluate the recovery from exercise-introduced muscle fatigue. The Friedman test followed by the Nemenyi test and the Mann-Whitney U test were applied in statistics. The SampEn and %DET change rate did not show any significant differences at four time points in the pre-condition group. However, there were significant delayed effects instead of immediate effects on improving muscle fatigue in the post-condition group (SampEn change rate: baseline 0.0000 ± 0.0000 vs. post 2 0.1105 ± 0.2253, p < 0.05; baseline 0.0000 ± 0.0000 vs. post 3 0.0627 ± 0.4665, p < 0.05; post 1-0.0321 ± 0.2668 vs. post 3 0.0627 ± 0.4665, p < 0.05; and %DET change rate: baseline 0.0000 ± 0.0000 vs. post 2-0.1240 ± 0.1357, p < 0.01; baseline 0.0000 ± 0.0000 vs. post 3 0.0704 ± 0.6495, p < 0.05; post 1 0.0700 ± 0.3819 vs. post 3 0.0704 ± 0.6495, p < 0.05). Moreover, the SampEn change rate of the post-condition group (0.1105 ± 0.2253) was significantly higher than that of the pre-condition group (0.0006 ± 0.0634, p < 0.05) at the post 2 time point. No more significant between-groups difference was found in this study. This is the first study demonstrating that both the pre-condition and post-condition of cupping therapy are useful for reducing muscle fatigue. The post-condition cupping therapy can e ffectively alleviate exercise-induced muscle fatigue and there is a significant delayed effect, especially 3h after the interventions. Although the pre-condition cupping therapy can not significantly enhance muscle manifestations, it can recover muscles into a non-fatigued state.

Oncology care model cost data for breast, lung, and multiple myeloma: Influence of outpatient rehabilitation therapy services.

14 Background: High value cancer care is defined by access to coordinated, appropriate healthcare services that achieve optimal outcomes at a reasonable cost. Evidence supports outpatient cancer rehabilitation (physical, occupational or speech therapy) as a mechanism to improve outcomes such as health-related quality of life, suggesting that integration of these services is beneficial for cancer survivors. However, the impact of outpatient rehabilitation services on healthcare costs is unknown. We aimed to compare cost segments between those who attended community-based outpatient rehabilitation therapy services (Rehab) versus those who did not (Non-rehab). We hypothesized that healthcare costs would be lower for the Rehab group in the following cost segments: emergency department (ED), part D drugs, home health services, skilled nursing facility services (SNF), inpatient rehabilitation facilities (IRF), and hospice. Methods: This is a retrospective cohort study of Medicare beneficiaries who received chemotherapy at a large community oncology practice that participated in the oncology care model (OCM) program from 2018 to 2021. Two data sources were linked, OCM cost data and the rehabilitation medical record. This yielded sufficient sample sizes for analysis of breast, lung, or multiple myeloma (MM) cancer types. Rehab cases were then matched to Non-rehab cases 3:1 based on cancer type, stage, and sex. Cost variables included total cost of care (TCOC) and cost segments using OCM methodology. Mann-Whitney-Wilcoxon statistic (p&lt;.05) was used for analysis. Results: Cases (N=3,033) primarily had early-stage cancer (0 to 2, 74.8%) and were 70.4±7.3 (Rehab) or 71.6±8.5 years old at diagnosis (Non-rehab). Most had breast cancer (81.2%), followed by lung cancer (11.7%) and MM (7.2%). TCOC was $32,387 and $26,257 for the Rehab and Non-rehab groups, respectively. Costs were significantly lower for the Rehab group in five of the six segments analyzed; IRF costs were lower, but not statistically significant (Table). Conclusions: To our knowledge, this is the first study to explore the influence of real-world, outpatient cancer rehabilitation therapy services on the cost of cancer care. Community-based therapy services were associated with significantly lower costs in ED, part D drugs, home health, SNF, and hospice segments. Future studies examining rehabilitation services as a relatively low-cost supportive care option to meet patient needs and enhance high-value care are warranted. Healthcare segment costs for rehab vs. non-rehab cases. Rehab Non-rehab Between-group Difference Mean, (SD) Mean (SD) p-value ED $85 (260) $104 (372) .019 Part D drugs $4,813 (18,221) $5,675 (18,797) &lt;.001 Home health $433 (1,600) $705 (2,118) &lt;.001 SNF $160 (1,988) $386 (3,943) .046 Hospice $75 (770) $198 (1,529) &lt;.001 IRF $245 (2,275) $384 (3,277) .434

Effectiveness of Audit and Feedback and Academic Detailing Interventions to Support Safer Opioid Prescribing in Primary Care

BackgroundOpioids, prescribed to manage pain, are associated with safety risks. Quality improvement strategies such as audit and feedback and academic detailing may improve prescribing in primary care. MethodsWe used a matched-cohort design with claims databases. Participants were family physicians practicing in Ontario, Canada. The interventions were a voluntary audit and feedback report with or without academic detailing sessions. Physicians in the control group received neither intervention. The primary outcome was mean rate of high-risk opioid prescriptions per 100 patients per month. Data were analyzed comparing monthly percentage change in slope over 12 months before and 18 months after the intervention. Additional analyses considered only the subgroup of higher-prescribing physicians. ResultsThere were 1469 (25%) physicians in the audit and feedback group, 245 (4%) in the audit and feedback + academic detailing group, and 4211 (71%) matched controls. All groups showed a significant preintervention decline in opioid prescribing. There were no significant between-group differences in opioid prescribing postintervention. Among high-prescribing physicians, there was a significant reduction in the audit and feedback group (% change in slope = –0.37, 95% CI = –0.65 to –0.09, P < .01), but not in the academic detailing group (% change in slope = 0.19, 95% CI = –0.52 to 0.91, P = .59). ConclusionsThis study demonstrated declining secular trends in prescribing and suggests that two large-scale initiatives had limited additional benefits. We found some additional reductions after audit and feedback among the highest-volume opioid prescribers. Future interventions should focus on these physicians for the greatest benefit.

Low-dose titrated amitriptyline as second-line treatment for adults with irritable bowel syndrome in primary care: the ATLANTIS RCT.

Irritable bowel syndrome, characterised by abdominal pain and a change in stool form or frequency, is most often managed in primary care. When first-line therapies are ineffective, National Institute for Health and Care Excellence guidelines suggest considering low-dose tricyclic antidepressants as second-line treatment, but their effectiveness in primary care is unknown and they are infrequently prescribed by general practitioners. To evaluate the clinical and cost-effectiveness of low-dose titrated amitriptyline as a second-line treatment for irritable bowel syndrome in primary care. A pragmatic, randomised, multicentre, two-arm, double-blind, placebo-controlled trial. A nested, qualitative study explored participant and general practitioner experiences of treatments and trial participation, and implications for wider use of amitriptyline for irritable bowel syndrome in primary care. Participants, clinicians, investigators and analysts were masked to allocation. Fifty-five general practices in three regions in England (Wessex, West of England, West Yorkshire). Patients aged ≥ 18 years meeting Rome IV criteria for irritable bowel syndrome with ongoing symptoms after trying first-line treatments and no contraindications to TCAs. Amitriptyline 10 mg once-daily, self-titrated by participants to a maximum of 30 mg once-daily or matched placebo for 6 months. Participants randomised 1 : 1 with most having the option to continue blinded treatment for a further 6 months. The primary participant-reported outcome was the effect of amitriptyline on global irritable bowel syndrome symptoms at 6 months, measured using the irritable bowel syndrome Severity Scoring System, with a 35-point between-group difference defined as the minimum clinically important difference. The key secondary outcome was the proportion of participants reporting subjective global assessment of relief at 6 months, defined as somewhat, considerable, or complete relief of symptoms. Other secondary outcomes included: effect on global symptoms, via the irritable bowel syndrome Severity Scoring System, and subjective global assessment of relief of irritable bowel syndrome symptoms at 3 and 12 months; effect on somatic symptom-reporting at 6 months; anxiety an-d depression scores; ability to work and participate in other activities at 3, 6 and 12 months; acceptability, tolerability and adherence to trial medication. Four hundred and sixty-three participants were randomised to amitriptyline (232) or placebo (231). An intention-to-treat analysis of the primary outcome showed a significant difference in favour of amitriptyline for irritable bowel syndrome Severity Scoring System score between arms at 6 months [-27.0, 95% confidence interval (CI) -46.9 to -7.10; p = 0.008]. For the key secondary outcome of subjective global assessment of relief of irritable bowel syndrome symptoms, amitriptyline was superior to placebo at 6 months (odds ratio 1.78, 95% CI 1.19 to 2.66; p = 0.005). Amitriptyline was superior to placebo across a range of other irritable bowel syndrome symptom measures but had no impact on somatoform symptom-reporting, anxiety, depression, or work and social adjustment scores. Adverse event trial withdrawals were more common with amitriptyline (12.9% vs. 8.7% for placebo) but most adverse events were mild. The qualitative study thematically analysed 77 semistructured interviews with 42 participants and 16 GPs. Most participants found the self-titration process acceptable and empowering. General practitioners should offer low-dose amitriptyline to patients with irritable bowel syndrome whose symptoms do not improve with first-line therapies. Guidance and resources should support GP-patient communication to distinguish amitriptyline for irritable bowel syndrome from use as an antidepressant and to support patients managing their own dose titration. This trial is registered as ISRCTN48075063. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/162/01) and is published in full in Health Technology Assessment Vol. 28, No. 66. See the NIHR Funding and Awards website for further award information.

Physical activity and symmetry following total knee arthroplasty: Results of a pilot randomized trial

ObjectiveThis pilot trial examined a Physical Activity and Symmetry (PAS) intervention focused on common deficits of physical inactivity and joint loading asymmetry following total knee arthroplasty (TKA). DesignParticipants (n ​= ​60) were enrolled during routine physical therapy (PT) following TKA and randomized to the PAS intervention or an attention (ATT) control group. The PAS intervention included physical activity counseling and balance exercise to address joint loading symmetry; content was delivered during 2 sessions at the end of routine PT plus supplemental sessions 4-weeks and 8-weeks following PT. The ATT control condition included supplemental sessions at 4-weeks and 8-weeks focused on general evaluation of surgical recovery benchmarks. Primary outcomes were weekly minutes of moderate to vigorous physical activity (MVPA), measured with an accelerometer, and peak force loading symmetry (limb symmetry index; LSI) during a 10 ​m walk, measured with a 3-sensor in-shoe device. General linear mixed models compared changes in outcomes between randomized groups at 3-month and 6-month follow-up. ResultsBoth PAS and ATT groups increased MVPA, but there were no clinically meaningful between-group differences at 3- or 6-month follow-up (p ​> ​0.05). There were also no clinically meaningful between-group differences LSI at 3- or 6-month follow-up (p ​> ​0.05). ConclusionThe PAS intervention did not yield improvements beyond ATT control. It is possible that PAS components were being delivered as part of routine PT, and a more intensive intervention (e.g., more visits, guidance for exercise progression) or targeted approach (e.g., those with deficits at end of routine care) may be needed to further improve outcomes.

White matter integrity upon progesterone antagonism in individuals with premenstrual dysphoric disorder: A randomized placebo-controlled diffusion tensor imaging study

BackgroundPremenstrual dysphoric disorder (PMDD) is a depressive disorder triggered by fluctuations of progesterone and estradiol during the luteal phase of the menstrual cycle. Selective progesterone receptor modulation (SPRM), while exerting an antagonistic effect on progesterone and maintaining estradiol on moderate levels, has shown beneficial effects on the mental symptoms of PMDD. Progesterone is also known for its neuroprotective effects, while synthetic progestins have been suggested to promote myelination. However, the impact of SPRM treatment on white matter microstructure is unexplored. MethodsDiffusion tensor imaging was employed to collect data on white matter integrity in patients with PMDD, before and after treatment with ulipristal acetate (an SPRM) or placebo, as part of a double-blind randomized controlled-trial. Tract based spatial statistics were performed to investigate SPRM treatment vs. placebo longitudinal effects on fractional anisotropy (FA), mean diffusivity (MD), radial diffusivity (RD), and axial diffusivity (AD), on the whole white matter skeleton. ResultsVoxel-wise analyses indicated no change over time in any white matter microstructure metrics in individuals treated with SPRM versus placebo. Improvement in PMDD symptoms did not correlate with changes in white matter microstructure. In secondary, exploratory, cross-sectional comparisons during treatment, the SPRM group displayed lower FA and higher MD, RD, and AD in several tracts. ConclusionThe main findings suggest that SPRM treatment did not impact white matter microstructure compared with placebo. However, secondary exploratory analyses yielded between-group differences after treatment, which call for further investigation on the tracts potentially impacted by progesterone antagonism. Clinical trial registrationEUDRA-CT 2016–001719-19; “Selective progesterone receptor modulators for treatment of premenstrual dysphoric disorder. A randomized, double-blind, placebo-controlled study.”; https://www.clinicaltrialsregister.eu/ctr-search/trial/2016-001719-19/SE

Evaluation of preoperative intraperitoneal injection of bupivacaine for intraoperative antinociception in cats undergoing ovariohysterectomy: A randomized clinical trial

ObjectiveTo determine if preoperative intraperitoneal bupivacaine can minimize intra- and postoperative nociception/pain in cats undergoing ovariohysterectomy. Study designProspective, randomized, investigator-blinded, placebo-controlled clinical trial. AnimalsForty-seven, intact female cats. MethodsCats were anesthetized using a standard protocol and randomized to receive ultrasound-guided intraperitoneal 0.9 % saline (US-S) or 0.25 % bupivacaine (US-IPLA) before ovariohysterectomy. On recovery, US-S cats received 2 mg/kg robenacoxib subcutaneously and US-IPLA cats received equivalent volume of 0.9 % saline subcutaneously. Intraoperative outcome variables included heart rate (HR), respiratory rate (fR), systolic arterial pressure (SAP), and vaporizer setting associated with relevant surgical events characterized by manipulation of each ovarian pedicle (OP1, OP2) and the uterine body (UB). The postoperative outcome variable was need for rescue analgesia, determined using the Glasgow Composite Measure Pain Scale during 6 h after tracheal extubation. Intraoperative data were analyzed using two-way ANOVA and Šidák's multiple comparisons test. The probability of postoperative rescue analgesia was analyzed using the Gehan–Breslow–Wilcoxon test. Significance was p < 0.05. ResultsCompared to baseline, all surgical events caused significant increases in HR and SAP in both groups, fR increased in US-IPLA but not in US-S, vaporizer settings remained unchanged during OP1, OP2 and UB in group US-IPLA, and were significantly higher only during OP1 in group US-S. There were no significant between-group differences in intraoperative variables and postoperative need for rescue analgesia. Conclusions and clinical relevancePreoperative intraperitoneal bupivacaine had minimal effects on intraoperative indicators of nociception. The need for rescue analgesia was not significantly different between groups.

A Prospective Randomized Controlled Study of Stratafix versus Standard-of-Care for Deep Tissue Closure in Orthopedic Surgery.

Orthopedic deep surgical incisions require the approximation of 1 or multiple tissue layers. This prospective randomized controlled study aimed to assess the usefulness and effectiveness of a barbed suture technique (Stratafix symmetric PDS plus) versus the conventional interrupted knotted suture technique for deep tissue closure in orthopedic surgery by comparing deep fascia suture time, relative cost, and wound-related complications. A total of 254 patients with deep surgical incisions who underwent orthopedic surgery between October 1, 2020, and June 30, 2021, were recruited. Their general characteristics (age, sex, weight, height, body mass index, American Society of Anesthesiologists physical status score, total operation time, and length of deep incision) and factors related to deep incision wounds (suture type and number, wound closure time, and operation site outcomes) were collected. The general characteristics did not differ between the Stratafix and conventional groups. There were no between-group differences observed in total operation time or total anesthesia time. The wound suture times differed significantly. In the conventional group, the suture time per unit length was lower in the group with the length of deep incision under 20 cm but did not differ significantly for each wound size. In the Stratafix group, the suture time per unit length was lower in the group under 15 cm, with the shortest time observed for 10-14.9 cm, followed by 5.0-9.9 cm and the group under 5 cm. The conventional group developed 4 cases of superficial wound infection or surgical wound necrosis. One case of protruded suture tap occurred in the Stratafix group. The average suture time per unit length increased for lengths under 5 cm as barbed sutures required more time from the start of the first suture to finish of the last suture. There was no significant benefit for very short suture length. One barbed suture material allows a suture of approximately 10-12 cm; sutures beyond that require more time because the surgeon has to start again. The Stratafix group used less suture material than the conventional group.

Effectiveness of In-Home, Augmented Reality-Based Telerehabilitation After Anterior Cruciate Ligament Reconstruction: A Randomized Controlled Trial.

New digital technology-based rehabilitation may be a viable option for patients after anterior cruciate ligament reconstruction (ACLR), with advantages such as easy access to treatment and learning as well as cost-effectiveness. To investigate the effects of an augmented reality (AR)-based, telerehabilitation system in patients after ACLR compared with a brochure-based rehabilitation program in terms of patient-reported outcomes and functional performance measures. Randomized controlled trial; Level of evidence, 2. This was a multicenter, assessor-blinded study. Enrolled participants were allocated randomly to either the intervention group, who underwent AR-based telerehabilitation system, or to the control group, who underwent a brochure-based rehabilitation program with a self-log. Both groups performed the same postoperative rehabilitation exercise protocol. Subjective knee function was assessed using the International Knee Documentation Committee (IKDC) as the primary outcome; secondary outcomes were a numeric rating scale for pain, the EuroQol 5-Dimension 5-Level, isometric knee strength, range of motion, and the single-leg hop test. The intervention group also completed a satisfaction survey. Follow-up was conducted at 2, 6, 12, and 24 weeks postoperatively. A total of 28 patients were enrolled in each group; 1 patient in the control group was lost to follow-up. Patients in both groups demonstrated improvement on all outcomes over time. There were no significant between-group differences in the IKDC score from baseline to 12 weeks postoperatively. The intervention group saw a greater increase in the relative isometric strength of the quadriceps on the involved limb at 6, 12, and 24 weeks postoperatively (P < .05 for all). No significant group differences were observed in the remaining secondary outcomes. Study findings indicated that patients who underwent AR-based telerehabilitation in the early rehabilitation phase after ACLR demonstrated similar improvements as those who followed a brochure-based rehabilitation program and had a quicker recovery of knee extensor strength. NCT04513327 (ClinicalTrials.gov identifier).

Characteristics of Nasal Coarticulation by Nasality Visualization System in Children with Speech Sound Disorders

Objectives: In this study, we analyzed the nasal coarticulation characteristics of children with and without speech sound disorders by comparing nasalance scores according to speech contexts. Methods: The subjects of this study were 30 children, 15 children with speech sound disorder (SSD) and 15 typically developing (TD) children, aged 4 to 6 years old. Subjects were asked to speak stimuli in different speech contexts-low vs. high vowels, nasal consonant+vowel (NV) vs. vowel+nasal consonant (VN) syllables, words vs. nonwords - and nasalance scores were measured using the Nasality Visualization System (NVS) on their speech samples. Results: First, both groups showed significantly higher naslance scores for high vowels compared to low vowels, with a significant between-group difference in high vowel. Second, both groups showed significantly higher nasalance scores for VN syllables than for NV syllables, with no between-group difference. Third, both groups showed significantly lower nasalance scores in nonwords compared to words. While there was no group difference in the words, the nasalance scores of the SSD group was lower in the nonwords, which was significantly different from that of the TD groups. Conclusion: These results suggest that the SSD group exhibits somewhat different nasal characteristics than the TD group, and furthermore, that SSD children articulate phoneme sequences more segmentally in unlearned nonword contexts.

Effect of high-dose N-acetylcysteine on exacerbations and lung function in patients with mild-to-moderate COPD: a double-blind, parallel group, multicentre randomised clinical trial.

Evidence for the treatment of patients with mild-to-moderate chronic obstructive pulmonary disease (COPD) is limited. The efficacy of N-acetylcysteine (an antioxidant and mucolytic agent) for patients with mild-to-moderate COPD is uncertain. In this multicentre, randomised, double-blind, placebo-controlled trial, we randomly assigned 968 patients with mild-to-moderate COPD to treatment with N-acetylcysteine (600 mg, twice daily) or matched placebo for two years. Eligible participants were 40-80 years of age and had mild-to-moderate COPD (forced expiratory volume in 1 second [FEV1] to forced vital capacity ratio <0.70 and an FEV1 ≥ 50% predicted value after bronchodilator use). The coprimary outcomes were the annual rate of total exacerbations and the between-group difference in the change from baseline to 24 months in FEV1 before bronchodilator use. COPD exacerbation was defined as the appearance or worsening of at least two major symptoms (cough, expectoration, purulent sputum, wheezing, or dyspnoea) persisting for at least 48 hours. Assessment of exacerbations was conducted every three months, and lung function was performed annually after enrolment. The difference between the N-acetylcysteine group and the placebo group in the annual rate of total exacerbation were not significant (0.65 vs. 0.72 per patient-year; relative risk [RR], 0.90; 95% confidence interval [CI], 0.80-1.02; P = 0.10). There was no significant difference in FEV1 before bronchodilator use at 24 months. Long-term treatment with high-dose N-acetylcysteine neither significantly reduced the annual rate of total exacerbations nor improved lung function in patients with mild-to-moderate COPD. Chinese Clinical Trial Registration: ChiCTR-IIR-17012604.

Effectiveness of TheraPEP Versus Conventional Breathing Techniques in Managing Acute COPD Exacerbations

Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide, often complicated by acute exacerbations that impair lung function and quality of life. Effective airway clearance techniques are essential in managing exacerbations, but the comparative effectiveness of different methods remains unclear. This study aimed to evaluate the short-term effectiveness of TheraPEP, a positive expiratory pressure (PEP) device, versus the Active Cycle of Breathing Technique (ACBT) in managing acute COPD exacerbations. Methods: A randomized controlled trial (RCT) was conducted with 60 patients (≥40 years) admitted with acute exacerbations of COPD. Participants were randomly assigned to either the TheraPEP group (n=30) or the ACBT group (n=30). Each group received three daily sessions of their assigned therapy throughout their hospital stay. Primary outcomes included dyspnea, measured by the modified Borg Dyspnea Scale, and secondary outcomes included sputum clearance, lung function (FEV1, FVC, and FEV1/FVC ratio), oxygen saturation (SpO₂), and quality of life, measured by the Breathlessness, Cough, and Sputum Scale (BCSS). Data were collected at baseline, discharge, and 14-day follow-up. A two-way repeated-measures ANOVA was used to examine changes in dyspnea, lung function, sputum clearance, SpO₂, and BCSS scores over time (baseline, discharge, and 14-day follow-up) within and between groups. The main effects of time (within-subject factor) and group (between-subject factor) were assessed, along with the interaction effects (time × group). Results: Both groups demonstrated significant improvements in dyspnea, lung function, and quality of life from baseline to discharge and follow-up. However, the TheraPEP group showed significantly greater improvements in sputum clearance (p=0.01), oxygen saturation (p=0.03), and BCSS scores (p=0.03) compared to the ACBT group. No significant between-group differences were found for FEV1, FVC, or FEV1/FVC ratio (p &gt; 0.05). Conclusions: Both TheraPEP and ACBT are effective in managing acute COPD exacerbations, but TheraPEP offers additional benefits in terms of sputum clearance and oxygenation. These findings suggest that TheraPEP may be more suitable for patients with severe mucus hypersecretion. Further research is warranted to assess the long-term effects of these therapies on COPD progression and patient outcomes.

Testing a family system-based intervention (ENTREN-F Programme) for a paediatric obesity sample by a randomized controlled trial

This study evaluated the effectiveness of ‘ENTREN-F’ –a multi-component, family system-based intervention-for managing paediatric obesity at National Health Primary Care. A 3-arm, parallel-design, single-blinded randomized controlled trial (RCT), 165 families were randomized: Arm 1) ENTREN-F(n = 62) is a 12-week cognitive-behavioural intervention (CBT) family system-based programme, addressing lifestyle changes, children's emotional and social development and the family system, Arm 2) ‘ENTREN’ (n = 52) is a CBT family-based programme for children and parents, not addressing the family system, and Arm 3) Control group (CG) (n = 51) covers individual behavioural monitoring. All children were clinical interviewed to assess a diagnosis. Their effectiveness was assessed against six-month changes in children's body mass index (BMI) z-score, children's psychological well-being, levels of expressed maternal emotion, depression symptoms, parental feeding practices, levels of physical activity and sedentary lifestyles. The maintenance of the changes was evaluated for two years. High-attendance rates for ENTREN-F (72.6% vs. 66% vs. 33%, respectively) indicated its greater acceptance. After programme completion, the BMI z-score reduced by .5 points in almost 50% ENTREN-F (n = 22/45), 21.9% ENTREN (n = 7/32) and 11.8% (n = 2/17) CG participants. There were no significant differences between the three trial arms for anthropometric, psychological, or family-related measures. At the two-year follow-up, both ENTREN-F and ENTREN showed similar long-term effectiveness without between-group differences, and weight trajectories were favourable. ENTREN-F appears effective for childhood obesity management; however, the COVID-19 pandemic limited the sample size. Also, the tendency towards multiple differences in child and family outcomes could not be statistically shown. It also provides further evidence of the role of psychological and family-related factors that may underlie the origin and maintenance of weight gain.

Feasibility of a person-centred multidimensional interdisciplinary rehabilitation programme in community-dwelling people with dementia: a randomised controlled pilot trial

BackgroundA team-based, individualised rehabilitation approach may be required to meet the complex needs of people with dementia. This randomised controlled pilot trial evaluated the feasibility of a person-centred multidimensional interdisciplinary rehabilitation programme for community-dwelling older people with dementia and their informal primary caregivers.MethodsParticipants with dementia were randomised to an intervention group (n = 31, mean age (SD) 78.4 (6.0) years) or usual care (n = 30, mean age 79.0 (7.1)). The rehabilitation programme consisted of a 20-week rehabilitation period containing assessments and interventions based on each individual’s goals, and group-based physical exercise plus social interaction twice a week for 16 weeks at a rehabilitation unit. After 5 and 14 months, the interdisciplinary team followed up participants over two four-week periods. For both groups, dates of deaths and decision to move to nursing home over three years, as well as interventions for the relevant periods, were collected. Blinded assessors measured physical functions, physical activity, activities of daily living, cognitive functions, nutritional status, and neuropsychiatric symptoms at baseline and at 5, 12, 24, and 36 months.ResultsParticipants in the intervention group received a mean of 70.7 (20.1) interventions during the 20-week rehabilitation period, delivered by all ten team professions. The corresponding figures for the control group were 5.8 (5.9). In the intervention group, all but one participated in rehabilitation planning, including goal setting, and attendance in the exercise and social interaction groups was 74.8%. None of the adverse events (n = 19) led to any manifest injury or disease. Cox proportional hazard regression showed a non-significant lower relative risk (HR = 0.620, 95% CI 0.27–1.44) in favour of the intervention for moving to nursing home or mortality during the 36-month follow-up period. Linear mixed-effect models showed non-significant but potentially clinically meaningful between-group differences in gait, physical activity, and neuropsychological symptoms in favour of the intervention.ConclusionsThe rehabilitation programme seems feasible among community-dwelling older people with dementia. The overall results merit proceeding to a future definitive randomised controlled trial, exploring effects and cost-effectiveness. One could consider to conduct the programme earlier in the course of dementia, adding cognitive training and a control attention activity.Trial registrationThe study protocol, ISRCTN59155421, was registered online 4/11/2015.

Biological sex as a tailoring variable for exercise prescription in hospitalized older adults

BackgroundSex-based differences in the clinical presentation and outcomes are well-established in patients hospitalized for geriatric syndromes. We aimed to investigate sex differences in response to in-hospital exercise on function, strength, cognition, and quality of life in acute care admissions. Methods570 patients (mean age 87 years, 298 females [52.3%]) admitted to acute care for elderly units were randomized to multicomponent exercise emphasizing progressive resistance training or usual care. Functional assessments included Short Physical Performance Battery (SPPB), grip strength, Mini-Mental State Examination (MMSE), and health-related quality of life (EQ-VAS). ResultsExercising females showed more significant SPPB improvements than males (between-group difference 1.48 points, p = 0.027), exceeding the minimal clinically significant difference. While female participants significantly increased handgrip strength and male patients improved cognition after in-hospital exercise compared to the control group (all p < 0.001), no sex differences occurred. ConclusionsFemales demonstrate more excellent physical function improvements compared to male older patients. Findings highlight the importance of tailored exercise incorporating patient factors like biological sex in geriatric medicine. Trial registrationNCT04600453.

Effect of Preoperative Autologous Blood Storage in Major Hepatectomy for Perihilar Malignancy: A Randomized Controlled Trial.

To reappraise whether preoperative autologous blood donation reduces post-hepatectomy liver failure (PHLF) in major hepatectomy for perihilar malignancy. Autologous blood storage and transfusion are carried out to reduce the use of allogeneic blood transfusion during hepatectomy and prevent postoperative complications. However, the clinical benefit in major hepatectomy has been controversial. This randomized clinical trial included patients who underwent major hepatectomy with extrahepatic bile duct resection for perihilar malignancy. Eligible patients were randomly assigned (1:1) to undergo surgery with or without the use of autologous blood transfusion. The primary outcome was the incidence of clinically relevant PHLF (grade B/C according to the International Study Group of Liver Surgery definition). Between February 6, 2019, and May 12, 2023, 138 consecutive patients were enrolled in the study (blood storage group n=68, non-storage group n=70). Twenty-five patients who did not undergo resection were excluded; the remaining 113 patients were investigated as the full analysis set (blood storage group n=60, non-storage group n=53). Surgical procedures, operative time, and blood loss were not significantly different between the two groups. The incidence of PHLF was comparable (blood storage group n=10 [17%], non-storage group n=10 [19%]; P=0.760). There were also no between-group differences in other postoperative outcomes, including the incidence of Clavien-Dindo Grade Ⅲ or higher (72% vs. 72%, P=0.997) and median duration of hospital stay (25 vs. 29d, P=0.277). Autologous blood storage did not contribute to reducing the incidence of PHLF in patients undergoing major hepatectomy.

The Effect of Vitamin D Supplementation with or without Calcium on Vitamin D Epimer and Metabolites.

A possible role of vitamin D epimers and metabolites in the measurement and response to treatment of vitamin D has been reported recently. Furthermore, the influence of underlying vitamin D receptor (VDR) genetic polymorphisms which have been linked to diseases such as obesity remains unclear. We therefore aimed to examine the influence of vitamin D3 and calcium supplements on vitamin D epimer and metabolite concentrations in subjects with and those without vitamin D receptor (VDR) gene polymorphisms. A total of 277 participants who were part of a randomized intervention trial of vitamin D3 and calcium or a placebo for 6 months had clinical and anthropometric assessments. Blood samples were taken for measurements of vitamin D, epimers and metabolites of vitamin D, four vitamin D receptor gene polymorphism SNPs, namely, BsmI, FokI, TaqI, and ApaI, metabolic and inflammatory markers, and related biochemical variables. Repeated-measures analysis of variance was used to assess the between-group difference in cumulative changes in vitamin D epimers and metabolites at 6 months after adjusting for the presence of the 4 VDR genotypes and allele gene polymorphisms. Overall, 277 participants, with a mean (±SD) age of 41 ± 12 and 204 (74%) of whom were female, were included in the study. We found no statistically significant differences in vitamin D metabolites or (epimers) between male and females or younger subjects compared to those over 40 years of age except in 7C4 BL (p < 0.05). There was a statistically significant difference in 1,25(OH)2D3 concentrations between subjects with and those without genotypes AG and the allele G SNP2_Taql VDR gene polymorphism. Vitamin D3 concentrations were also significantly lower in subjects with the CC SNP3_Apal gene polymorphism compared to those without the CC SNP3 gene. No statistically significant effects were seen on vitamin D epimers and metabolites concentration in response to supplements before or after adjusting for the presence of the 4 VDR genotypes and allele gene polymorphisms. The CC SNP3 gene had statistically significant influence on vitamin D3 levels. Vitamin D and/or calcium supplements, however, had no effects on vitamin D epimer and metabolite concentration before or after adjusting for the presence of the 4 VDR genotypes and alleles.

Co-Occurring Mental and Physical Health Conditions Among Older Adults With and Without Post-traumatic Stress Disorder: A Case Control Study.

Rates of post-traumatic stress disorder (PTSD) among older adults range from 0.4%-4.5%. Research examining PTSD in adults has demonstrated numerous associations between physical and mental health conditions; however, these are less well characterized in older adults. The current study aimed to identify base rates of such conditions among older adults with and without a history of PTSD. In a case control design using the National Alzheimer's Coordinating Center Uniform Data Set, adults 65 years or older from the United States who endorsed either the presence or absence of PTSD were matched by age to assess between-group differences (N = 472; 236 pairs). We examined differences across self-reported sociodemographics and physical health, mental health, and substance use histories. More participants with a history of PTSD identified as Hispanic, non-white, non-married, and functionally independent. Compared to individuals without a history of PTSD, significantly more individuals with a history of PTSD had histories of depression, anxiety, substance abuse, Parkinson's disease, seizures, insomnia, and TBI. Among participants without PTSD history, only 14.7% reported a history of TBI, compared to 41.1% of individuals with PTSD history. Findings showed expected trends toward worse physical and mental health among older adults with self-reported PTSD. There was a striking difference in the frequency of TBI history between participants with and without PTSD. These findings underscore a need to assess for PTSD among older adults, particularly those reporting a history of TBI.

Mindfulness-based family psychoeducation intervention for caregivers of young adults with first-episode psychosis: results at 9-month follow-up.

To investigate the effects of a mindfulness-based family psychoeducation (MBFPE) intervention on caregivers and the young adults with first-episode psychosis in mental health care. Sixty-five caregivers were randomly assigned to the MBFPE program (n = 33) or an ordinary family psychoeducation (FPE) program (n = 32). Eighteen young adults in recovery (YAIR) also participated in the study. All of the participants completed the assessments before participating in the intervention (T1), after the intervention (T2), and at 9-month follow-up (T3). Intention-to-treat analyses were conducted. The caregivers reported a significant and large effect size on positive caregiving experiences based on a Time × Group analysis (g = 0.862, p = 0.006). Among the YAIR participants, between-group differences were significant in their perceptions of caregivers' expressed emotions, including large effect sizes of perceived criticism (g = 1.396, p = 0.049) and hostility (g = 1.444, p = 0.043). Caregiver demographics, including age, education level, socioeconomic status, and number of family members, were found to moderate the effect sizes of the variables studied. This study provides evidence of the effects of MBFPE programs on the outcomes of caregivers and the young adults with first-episode psychosis in their care. Specifically, the MBFPE program in this study played a greater role in promoting positive caregiving experiences and changing caregivers' expressed emotions, especially their expressed criticism of YAIR, compared with the regular FPE program. Therefore, the application of mindfulness training to promote family care and YAIR recovery should be encouraged. ClinicalTrials.gov, identifier NCT03688009.