Difference In Mean Change Research Articles

Comparative long-term outcomes of vitrectomy combined with anterior chamber intraocular lens to intra-scleral haptic fixation of posterior chamber intraocular lens

PurposeTo evaluate the long-term clinical outcomes in patients with combined pars plana vitrectomy (PPV) with anterior chamber intraocular lens (ACIOL) to intrascleral haptic fixation (ISHF) using the Agarwal technique with fibrin glue to secure the scleral flap of a posterior chamber intraocular lens.MethodsRetrospective, consecutive, single-center, comparative case series. 83 eyes were studied. Patients with < 8 months of follow-up were excluded. Detailed pre-, intra-, and post-operative complications were analyzed using mixed model univariate analysis and t-test. Pre- and post-operative best corrected visual acuity (BCVA) was analyzed.ResultsTwenty-five subjects met entry criteria. Mean age at time of surgery was 70.4 ± 17.7 years in the ACIOL group (n = 12) and 54.6 ± 21.1 years in the ISHF group (n = 13; p = 0.03). Mean follow-up was 38.2 months. Incidence of corneal decompensation was similar in the ACIOL and ISHF lens group (p = 0.93). There was no difference in the BCVA mean change or cystoid macular edema (CME) at the final visit between the groups (p = 0.47; p = 0.08), but there was a trend toward increased CME in the ACIOL group.ConclusionsPPV with concomitant placement of either ACIOL or ISHF lens result in improvement in BCVA. Both procedures are well tolerated and result in favorable outcomes with long-term follow-up though varying patient populations do not allow precise comparison between the two groups.

The impact of religious spiritual care training on the spiritual health and care burden of elderly family caregivers during the COVID-19 pandemic: a field trial study

BackgroundFamily caregiving is associated with many physical and psychological problems for caregivers, but the effect of spiritual support on reducing their issues during a crisis is also the subject of research. The study aims to examine the impact of religious spiritual care training on the spiritual health and care burdens of elderly family caregivers during the COVID-19 pandemic.MethodsThe randomized controlled field trial involved 80 Iranian family caregivers in Bushehr City, who were selected by convenience sampling based on the inclusion criteria and divided into experimental (40 people) and control (40 people) groups by simple random sampling in 2021 and 2022. Data collection was conducted using spiritual health and care burden questionnaires using the Porsline software. The virtual intervention included spiritual and religious education. Four virtual sessions were held offline over two weeks. The first session was to get to know the participants and explain the purpose, The second session focused on the burden of care, the third on empowerment, and the fourth on mental health and related issues. In the control group, daily life continued as usual during the study.ResultsMean changes in existential health (3.40 ± 6.25) and total spiritual health (5.05 ± 11.12) increased in the intervention group and decreased in the control group. There were statistically significant differences between the two groups for existential health (t = 3.78, p = 0.001) and spiritual health (t = 3.13, p = 0.002). Cohen’s d-effect sizes for spiritual health and caregiving burden were 0.415 and 0.366, respectively. There was no statistically significant difference in mean changes in religious health (p = 0.067) or caregiving burden (p = 0.638) between the two intervention and control groups.ConclusionGiven that the religious-spiritual intervention had a positive effect on existential health and no impact on religious health or care burden, it is recommended that comprehensive planning be undertaken to improve the spiritual health of family caregivers to enable them to better cope with critical situations such as a COVID-19 pandemic.Trial registrationIRCT code number IRCT20150529022466N16 and trial ID number 48,021. (Registration Date2020/06/28)

Novel Thermoreversible Reverse-Phase-Shift Foam With Deployment System for Treatment of Penetrating Globe Trauma in a Newly Described Porcine Model.

The initial management of penetrating ocular injuries is a major sight-threatening problem for both civilian and military medicine. A novel device (Eye-Aid) temporarily tamponades leakage from such injuries while being easy to remove upon arrival to specialized ophthalmologic care. Eye-Aid consists of a protective eye shield with an adhesive backing that connects to a portable canister containing rapidly deployable thermoresponsive foam. The aim of this study was to compare the use of the novel Eye-Aid device to control in a new live swine ocular injury model. Bilateral penetrating ocular injuries were created on 14 male Yorkshire swine in a standardized manner using a 16-gauge needle device to puncture the central cornea and cause a full-thickness wound. Researchers randomized eye intervention side, with the contralateral eye used as paired control. Two minutes after the injury, the eye shield components of the Eye-Aid system, which has a sticky pad for attachment to the skin and a luer-lock for foam deployment, were placed bilaterally. Eight minutes after the injury, foam was deployed for the intervention eye according to the device instructions for use. For the control eye, no additional procedures were performed. Six hours post-injury, end A-scan and intraocular pressure (IOP) were measured. Primary study outcome was change in axial length of the globe. Secondary outcomes were as follows: (1) Presence of full anterior chamber collapse, defined as a lack of measurable anterior lens capsule-reflex (ALC-reflex) on A-scan and (2) change in IOP. Outcomes were analyzed as paired intra-animal data, with intervention and control data for each animal. A paired t-test was used to analyze the difference in axial length change and IOP change between treatment groups, whereas a conditional logistic regression was used to analyze dichotomous ALC-reflex outcome and estimate the odds ratio associated with the Eye-Aid device. A significant difference (P < .0001) in mean change in axial length between intervention (-210 μm) and control (-1,202 μm) groups was found. There was a significant difference in ALC-reflex presence, with 79% of eyes having an ALC-reflex in the intervention group, compared to 14% in the control (P = .008). IOP remained higher in the intervention group, with a mean change of -1.5 mmHg for the intervention group compared to -4.0 mmHg in the control (P = .0001). This study describes the first development of an in vivo large animal ocular injury model that realistically approximates the emergent time course and pathophysiology of patients with full-thickness corneal open globe injuries. It also gives the first description of using thermoreversible hydrogel foam for such injuries. Eye-Aid was found to be significantly better than control for treatment of such injuries, based on measurements of both structure and pressure. Assuming that the absence of an ALC-reflex demonstrates complete anterior chamber collapse, the Eye-Aid group demonstrated a 79% eye "save" rate compared to only 14% in the control group, as described earlier. This results in a Number Needed to Treat of 3 for this finding. Eye-Aid additionally demonstrated several characteristics that would be beneficial in a device targeted for emergent deployment by non-ophthalmologists.

Comparison of two techniques of administering the Valsalva manoeuvre in patients under general anaesthesia: A randomised controlled study.

Surgeons often request a Valsalva manoeuvre (VM) at the end of surgery (head-neck surgery, craniotomy) to check haemostasis and to unmask covert venous bleeders. We aimed to compare an anaesthesia machine-generated objective technique for delivering VM under pressure-control (PC) mode with the traditional subjective technique of delivering VM in manual mode. This randomised controlled study included 60 adult patients randomised to manual (Group M) and controlled ventilation (Group C) groups. Our primary outcome measure was internal jugular vein (IJV) diameter at pre-determined time points (T0 = baseline, T1 = VM initiation, T2 = 20 s after VM initiation, T3 = immediately after VM release, and T4 = 1 min, T5 = 2 min and T6 = 5 min post-VM release). Secondary outcome measures included mean arterial pressure (MAP), heart rate, time to desired plateau airway pressure, number of patients with bleeders unmasked and surgeon satisfaction. Independent/paired sample t-tests were applied. Results are expressed as mean (standard deviation), mean difference (95% confidence interval), dotted box-whisker plots and trendlines. P <0.05 is considered statistically significant. Mean differences in diameter changes in IJV (in centimetres) in the mediolateral and anteroposterior directions between Group C and Group M were -0.136 (-0.227, -0.044) and -0.073 (-0.143, -0.002), respectively. VM in the PC mode produced more significant IJV dilatation (P = 0.004, P = 0.044). MAP at T0 and T1 was comparable. At T2 and T3, there was a more significant fall in MAP in Group C versus Group M (P = 0.018 and P = 0.021, respectively). At T4, T5 and T6, MAP was comparable. Performing VM in PC mode is a better technique based on IJV diameter, haemodynamics, bleeder unmasking and surgeon satisfaction.

Mind the gap—What is the appropriate time interval between sequential dentine stimuli to elicit a dentine hypersensitivity pain response in clinical studies?

ObjectivesTo determine the time interval required for a tooth diagnosed with DH to recover from a stimulus (cold air-blast/tactile) and respond with a similar elicited pain response to a repeat stimulus. MethodsA single-centre, non-randomised, clinical study in healthy adult volunteers. Eligible participants with ≥1 tooth with either a qualifying Schiff score ≥2 following cold air-blast or tactile Yeaple score of ≤20 g were allocated to tactile or air-blast group. Following primary stimulation, the designated tooth was restimulated 10, 5, 2 min and immediately after initial pain cessation. Pain was recorded with participant VAS and investigator Schiff for air-blast. Results40 participants completed the study per group. There was a significant difference in VAS scores for tactile 4 delay intervals (p < 0.001) but not air-blast stimulus, and a significant difference in mean change in VAS score from immediate to two-minute delay between stimuli (8.0 tactile vs 0.8 air-blast, p = 0.011). VAS scores in response to either stimulus showed very wide variation between participants, but changes over delay intervals within participants were relatively slight. There was a significant progressive decrease in mean Schiff score with shortening delay intervals from 10 min (2.38) to stimulation immediately after pain cessation (2.15), p = 0.018. ConclusionsThe findings suggest healthy teeth recover after DH stimulation more quickly following an air-blast than tactile stimulus, with around 2 min allowing recovery from both. Many factors including habituation and pain measurement subjectivity need to be considered. It would be prudent for future studies to use of ≥3 min delays. Clinical significanceNo clinical study has attempted to determine the appropriate interval between successive stimuli in DH patients. The results will impact directly on the conduct of DH trials. These findings suggest the interval could be reduced to around 2-min, but the current standard of 5-min is sufficiently long to give valid results.

Acute Affective Responses to Virtual Reality Exercise: A Crossover Randomized Clinical Trial.

Virtual reality (VR) exercise aims to offer positive affective and sensory experiences through an immersive experience rich in audiovisual stimuli. Notwithstanding, there is a paucity of large sample size studies comparing the acute effects of VR exercise compared with a matched exercise performed in a non-VR environment. The study compared the acute effects of a VR exercise session versus a matched non-VR exercise session in effect, pleasure, enjoyment, perceived exertion, and heart rate. This is a crossover randomized clinical trial. The time, difficulty, and exercise type of the non-VR exercise were matched to VR exercise. Before and immediately after each session, participants responded to the Borg's Perceived Exertion Scale, the Feeling Scale and the Felt Arousal Scale, and the Physical Activity Enjoyment Scale. The analyses were conducted with Generalized Linear Models, Wilcoxon's, and T-test for paired samples. A total of 83 adults (40 females) aged 35.46 years were included in the study. Participants in the VR condition had a greater increase in affect (mean change difference = 0.95, 95% confidence interval [CI] = 0.83-1.06, P < 0.001), arousal (mean change difference = 0.37, 95% CI = 0.23-9.50, P < 0.001). The pleasure and enjoyment median after the VR session were higher. In conclusion, the immersive VR exercise was more strenuous, but resulted in a better affective response, greater pleasure, and enjoyment.

Intra-arterial nicardipine versus verapamil during transradial access coronary catheterization

IntroductionIntra-arterial (IA) vasodilators are recommended during transradial access (TRA) to prevent radial artery spasm (RAS). The American Heart Association (AHA) recommends either IA verapamil, diltiazem, nicardipine, or nitroglycerin to prevent RAS. To our knowledge, the efficacy of RAS prevention and patient tolerability of verapamil and nicardipine has not been directly compared in a randomized fashion. MethodsWe conducted a prospective, single-blinded randomized clinical trial comparing the discomfort experienced by patients receiving either 400 μg of IA nicardipine (n = 26) or 5 mg of IA verapamil (n = 29). Patient discomfort and/or pain was assessed using the Visual Analogue Scale (VAS) both before and after IA administration of nicardipine or verapamil. ResultsThere was a statistically significant difference in mean change in VAS scores between the 2 groups, with an average increase in VAS score of 0.88 in the nicardipine group and 4.81 in the verapamil group (p < 0.0001). The overall rate of RAS was low in our study (5.5 %) with no significant difference in RAS incidence between the 2 groups (p = 0.465). The nicardipine group had 2 RAS cases (7.7 %), with 1 requiring a change in strategy (3.8 %). The verapamil group had 1 RAS case (3.4 %) that did not require a change in strategy. ConclusionIn this trial, we showed that nicardipine causes significantly less discomfort and pain compared to verapamil during IA administration for TRA cardiac catheterization.

A phase 2a study investigating the effects of ritlecitinib on brainstem auditory evoked potentials and intraepidermal nerve fiber histology in adults with alopecia areata.

Reversible axonal swelling and brainstem auditory evoked potential (BAEP) changes were observed in standard chronic (9-month) toxicology studies in dogs treated with ritlecitinib, an oral Janus kinase 3/tyrosine kinase expressed in hepatocellular carcinoma family kinase inhibitor, at exposures higher than the approved 50-mg human dose. To evaluate the clinical relevance of the dog toxicity finding, this phase 2a, double-blind study assessed BAEP changes and intraepidermal nerve fiber (IENF) histology in adults with alopecia areata treated with ritlecitinib. Patients were randomized to receive oral ritlecitinib 50 mg once daily (QD) with a 4-week loading dose of 200 mg QD or placebo for 9 months (placebo-controlled phase); they then entered the active-therapy extension and received ritlecitinib 50 mg QD (with a 4-week loading dose of 200 mg in patients switching from placebo). Among the 71 patients, no notable mean differences in change from baseline (CFB) in Waves I-V interwave latency (primary outcome) or Wave V amplitude on BAEP at a stimulus intensity of 80 dB nHL were observed in the ritlecitinib or placebo group at Month 9, with no notable differences in interwave latency or Wave V amplitude between groups. The CFB in mean or median IENF density and in percentage of IENFs with axonal swellings was minimal and similar between groups at Month 9. Ritlecitinib treatment was also not associated with an imbalanced incidence of neurological and audiological adverse events. These results provide evidence that the BAEP and axonal swelling finding in dogs are not clinically relevant in humans.

Effectiveness of a group psychological intervention to reduce psychosocial distress in adolescents in Pakistan: a single-blind, cluster randomised controlled trial

Emotional problems in adolescents living in low-income and middle-income countries (LMICs) remain largely unaddressed; key reasons include a scarcity of trained mental health professionals and unavailability of evidence-based, scalable psychological interventions. We aimed to evaluate the effectiveness of a non-specialist-delivered, group psychological intervention to reduce psychosocial distress in school-going adolescents in Pakistan. In a two-arm, single-blind, cluster randomised controlled trial, eligible public school clusters from a rural subdistrict of Gujar Khan, Rawalpindi, Pakistan, were randomised (1:1, stratified by sex) using permuted block randomisation into intervention (n=20) and wait-list control (n=20) groups. Adolescents aged 13-15 years who provided informed assent and caregivers' consent were screened for psychosocial distress using the youth-reported Pediatric Symptoms Checklist (PSC; total psychosocial distress scores from 0 to 70), and those scoring 28 or more and their caregivers were enrolled into the trial. Adolescents in the intervention group received seven weekly group sessions and their caregivers received three biweekly group sessions in school settings from trained non-specialists. The primary outcome was change from baseline in the total PSC scores at 3 months post-intervention. The trial was registered prospectively with the International Standard Randomised Controlled Trial Number registry, ISRCTN17755448. From the 40 school clusters that were included, 282 adolescents in the intervention group and 284 adolescents in the wait-list control group were enrolled between Nov 2 and Nov 30, 2021. At 3 months, adolescents in the intervention group had significantly lower mean total score on the PSC compared with adolescents in the control group (mean difference in change from baseline 3·48 [95% CI 1·66-5·29], p=0·0002, effect size 0·38 [95% CI 0·18-0·57]; adjusted mean difference 3·26 (95% CI 1·46-5·06], p=0·0004, effect size 0·35 (0·16-0·55). No adverse events were reported in either group. The group psychological intervention most likely represents a feasible and effective option for adolescents with psychosocial distress in school settings. UK Medical Research Council, Foreign Commonwealth and Development Office, Department of Health and Social Care. For the Urdu translation of the abstract see Supplementary Materials section.

Preoperative Hip Injection Response Does Not Reliably Predict 2-Year Postoperative Outcomes After Hip Arthroscopy for Femoroacetabular Impingement

PurposeTo determine whether response to preoperative local anesthetic or corticosteroid intra-articular injections can predict 2-year postoperative outcomes in patients undergoing hip arthroscopy for femoroacetabular impingement syndrome (FAIS). MethodsThis was a retrospective analysis of patients undergoing hip arthroscopy for FAIS at a single institution from 2014-2020. Patients who underwent preoperative intra-articular hip injection were classified based on injection type (local anesthetic, corticosteroid) and whether they experienced pain relief following injection (responders, non-responders). Responders were matched 2:1 by age, BMI, and sex with non-responders. Patient reported outcomes (PROs) including Hip Disability and Osteoarthritis Outcome Score (HOOS), 12-item Short-Form Survey mental (SF-12-MCS) and physical component summary (SF-12-PCS) and visual analogue scale (VAS) pain were collected preoperatively and 2-years postoperatively. Mean score change and Minimal Clinically Important Difference (MCID) achievement were calculated and compared between groups. ResultsThe matched cohort included 126 total patients (42 non-responders, 84 responders; 74.6% female; mean ± SD age: 30.9 ± 9.9 years; BMI: 24.7 ± 3.7 kg/m2) with no differences in demographic or radiographic hip variables. Both groups demonstrated significant 2-year postoperative score improvements across all PROs, except SF-12-MCS, which remained unchanged. There was no difference in mean score change or MCID achievement across all PROs between corticosteroid injection responder and non-responder groups. In the local anesthetic group, MCID achievement was similar across all PROs, except VAS pain which showed greater percentage of MCID achievement among local anesthetic non-responders relative responders (Responders: 55.0%, Non-responders: 89.5%; p = 0.03). Significant ceiling effects were most readily apparent among the injection responders group with greater percentages of patients achieving maximal 2-year postoperative survey scores (36.9% HOOS-ADL, 19.0% HOOS-Pain, 15.5% HOOS-QoL, 32.1% HOOS-Sport). ConclusionsResponse to preoperative injection with either corticosteroid or local anesthetic did not predict 2-year outcomes after hip arthroscopy in patients with FAIS. Level of EvidenceLevel III, retrospective matched cohort study.

Is radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses more effective than advice plus customised foot orthoses alone in the treatment of plantar fasciopathy? A double-blind, randomised, sham-controlled trial

ObjectivesTo assess whether radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses is more effective than advice plus customised...

Association of Medication Adherence and Health Status in Heart Failure With Reduced Ejection Fraction: Insights From the CHAMP-HF Registry.

The foundation for managing heart failure with reduced ejection fraction (HFrEF) is adherence to guideline-directed medical therapy. Finding an association between medication adherence and patients' health status (their symptoms, function, and quality of life) can be used to underscore its importance to patients. The association of self-reported medication adherence in US outpatients with HFrEF enrolled in the Change the Management of Patients with Heart Failure registry from 2015 to 2017 was compared with their health status at baseline and 12 months later. A secondary analysis of changes in adherence between baseline and 6 months with 6-month health status was also performed. Medication adherence was assessed with the self-reported 4-item Morisky-Green-Levine Medication Adherence Scale, with scores ≥1 classified as nonadherent. The primary health status outcome was the disease-specific 12-item Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS; range, 0-100; higher is better). Robust linear regression models adjusted for confounders were used. After excluding those who died (n=316) or did not provide 12-month KCCQ (n=1285), 3495 outpatients with HFrEF were included, of whom 1108 (31.7%) reported being nonadherent. Nonadherent participants were younger, had significantly worse baseline health status (-5.83-point difference; P<0.001), and showed less improvement at 12 months (-1.7-point difference in mean change; P=0.017) than adherent participants. Among nonadherent patients at baseline, those whose adherence improved trended toward greater 6-month health status improvements than those remaining nonadherent (fully adjusted difference of 2.52 points; P=0.054). In HFrEF, medication nonadherence was associated with worse health status and less improvement over the following year. Improvements in adherence were associated with better health status than remaining nonadherent, underscoring the importance of supporting adherence with guideline-directed medical therapy in patients with HFrEF.

Effectiveness of Reading Interventions on Literacy Skills for Chinese Children with and Without Dyslexia: a Meta-analysis of Randomized Controlled Trials

This meta-analysis synthesizes 49 standardized mean-change differences between control and treatment groups as effect sizes from 28 independent studies, investigating the efficacy of existing reading interventions on literacy skills for Chinese children. Six potentially important moderators were considered in this study. These moderators included intervention outcome, intervention method, intervention timing, participant type, intervention form, and intervention implementer. Overall, the existing reading intervention significantly impacted Chinese children’s literacy achievement (g = 0.68). Different intervention methods showed somehow different effects on literacy outcomes. Specifically, fluency training (g = 1.78) appeared as the most effective intervention method with a large effect. Working memory training (g = 0.80), phonological training (g = 0.69), orthographic training (g = 0.70), and morphological training (g = 0.66) had significant and medium effects on improving literacy skills of Chinese children. In addition, reading intervention improved literacy skills of older children (g = 0.90) and younger children (g = 0.63) comparably. However, children with dyslexia (g = 0.87) seemed to benefit more than typically developing children (g = 0.49) from reading interventions. Reading interventions seemed to have a better effect on word spelling (g = 0.93) than word reading (g = 0.63). Interventions delivered in group (g = 0.78) seemed to be more effective than interventions delivered individually (g = 0.45). Children gained more from interventions administered by researchers (g = 0.85) or combined implementers (g = 1.11) than by parents (g = 0.27). These findings suggest that appropriate reading interventions are effective and essential for improving the literacy outcomes of Chinese children, but the efficacy might be different depending on the intervention methods, children’s literacy status, outcome measures, and intervention settings.

Home blood pressure-lowering effect of a non-steroidal mineralocorticoid receptor blocker, esaxerenone, versus trichlormethiazide for uncontrolled hypertension: the EXCITE-HT randomized controlled study.

The EXCITE-HT study aimed to evaluate the efficacy and safety of esaxerenone versus thiazide diuretics (trichlormethiazide) as second-line treatment for Japanese patients with uncontrolled essential hypertension. This was a 12-week, multicenter, randomized, open-label, parallel-group study. The non-inferiority of esaxerenone to trichlormethiazide was confirmed if the upper limit of the two-sided 95% confidence interval (CI) for the difference in systolic blood pressure (SBP)/diastolic blood pressure (DBP) change between groups was below 3.9/2.1 mmHg. A total of 295 and 290 patients were included in the esaxerenone and trichlormethiazide groups, respectively. The non-inferiority of esaxerenone to trichlormethiazide was demonstrated: least squares mean change differences in morning home SBP/DBP at end of treatment (EOT) were -2.2 (95% CI, -3.6, -0.8) mmHg for SBP/-0.6 (-1.4, 0.2) mmHg for DBP. Morning home, bedtime home, and office BP significantly decreased (all p < 0.001) from baseline to EOT in both groups. The urinary albumin-to-creatinine ratio and N-terminal pro-brain natriuretic peptide level decreased from baseline to Week 12 in both groups, with no notable intergroup difference. Serum potassium elevations occurred more frequently with esaxerenone, while serum potassium reductions occurred more with trichlormethiazide. Uric acid elevations were observed in both groups, but more frequently with trichlormethiazide than esaxerenone. No cases of gout occurred in this study. Reductions in estimated glomerular filtration rate were similarly observed in both groups. EXCITE-HT is the first randomized controlled study to demonstrate evidence that esaxerenone is non-inferior to trichlormethiazide as second-line treatment for Japanese patients with uncontrolled essential hypertension, with no new safety concerns. The EXCITE-HT study demonstrated the non-inferiority of esaxerenone to trichlormethiazide in its morning home blood pressure lowering effect and safety profile in Japanese patients with uncontrolled essential hypertension who were previously treated with an angiotensin II receptor blocker or calcium channel blocker.

Bone turnover biomarkers reflect radiation-induced bone injuries in women with non-metastatic rectal cancer.

Preoperative radiotherapy (RT) for non-metastatic rectal cancer reduces local recurrence rates but can cause pelvic insufficiency fractures. Despite the high morbidity from RT-induced skeletal injuries, predictive and preventive measures are lacking. How these injuries are reflected by bone biomarkers are largely unknown. The aim was to assess longitudinal changes in bone biomarkers and their relation to RT-related bone injuries in women with rectal cancer. This longitudinal cohort study includes 47 women with non-metastatic rectal cancer treated with surgery ± preoperative RT with or without chemotherapy. Sclerostin, bioactive sclerostin, C-terminal telopeptide cross-links of collagen type I (CTX), bone-specific alkaline phosphatase (BALP), and type I procollagen intact N-terminal propeptide (PINP) were measured at baseline, after RT, and 1 yr postoperatively. Pelvic magnetic resonance imaging was used for detection of skeletal injury. Sixteen of 36 (44%) irradiated women had radiation-induced bone injuries and were compared to 11 women (RT-) and 20 women (RT+) without bone injuries. Serum CTX, BALP, and PINP increased during the first year after RT in women with radiation-induced bone injuries. The difference in mean change of CTX (p=.037) and BALP (p=.042) was conferred by longitudinal regression analyses adjusted for serum estradiol. Serum sclerostin and bioactive sclerostin remained stable over time. Taken together, bone markers may be of interest for future research on fracture prediction or preventive measures in women susceptible to radiation-induced bone injury. Due to few measure points, the full pattern cannot be captured regarding the relation over time between bone biomarkers and skeletal injury from irradiation.

Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial.

Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient. To investigate the effect of acupuncture for DLSS. Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729). 5 hospitals in China. Patients with DLSS and predominantly neurogenic claudication pain symptoms. 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment. The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ. A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; P = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient. The SA could produce physiologic effects. Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment. 2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ).

Comparative Effectiveness of Three Digital Interventions for Adults Seeking Psychiatric Services

There is a substantial gap between demand for and availability of mental health services. Digital mental health interventions (DMHIs) are promising tools for bridging this gap, yet little is known about their comparative effectiveness. To assess whether patients randomized to a cognitive behavioral therapy (CBT)-based or mindfulness-based DMHI had greater improvements in mental health symptoms than patients randomized to the enhanced personalized feedback (EPF)-only DMHI. SETTING, AND PARTICIPANTS This randomized clinical trial was conducted between May 13, 2020, and December 12, 2022, with follow-up at 6 weeks. Adult patients of outpatient psychiatry services across various clinics within the University of Michigan Health System with a scheduled or recent outpatient psychiatry appointment were recruited. Eligible patients were randomized to an intervention arm. All analyses followed the intent-to-treat principle. Participants were randomized to 1 of 5 intervention arms: (1) EPF only; (2) Silvercloud only, a mobile application designed to deliver CBT strategies; (3) Silvercloud plus EPF; (4) Headspace only, a mobile application designed to train users in mindfulness practices; and (5) Headspace plus EPF. The primary outcome was change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9; score range: 0-27, with higher scores indicating greater depression symptoms). Secondary outcomes included changes in anxiety, suicidality, and substance use symptoms. A total of 2079 participants (mean [SD] age, 36.8 [14.3] years; 1423 self-identified as women [68.4%]) completed the baseline survey. The baseline mean (SD) PHQ-9 score was 12.7 (6.4) and significantly decreased for all 5 intervention arms at 6 weeks (from -2.1 [95% CI, -2.6 to -1.7] to -2.9 [95% CI, -3.4 to -2.4]; n = 1885). The magnitude of change was not significantly different across the 5 arms (F4,1879 = 1.19; P = .31). Additionally, the groups did not differ in decrease in anxiety or substance use symptoms. However, the Headspace arms reported significantly greater improvements on a suicidality measure subscale compared with the Silvercloud arms (mean difference in mean change = 0.63; 95% CI, 0.20-1.06; P = .004). This randomized clinical trial found decreases in depression and anxiety symptoms across all DMHIs and minimal evidence that specific applications were better than others. The findings suggest that DMHIs may provide support for patients during waiting list-related delays in care. ClinicalTrials.gov Identifier: NCT04342494.

Screen Media Use and Mental Health of Children and Adolescents

Excessive screen media use has been associated with poorer mental health among children and adolescents in several observational studies. However, experimental evidence supporting this hypothesis is lacking. To investigate the effects of a 2-week screen media reduction intervention on children's and adolescents' mental health. This prespecified secondary analysis of a cluster randomized clinical trial with a 2-week follow-up included 89 families (with 181 children and adolescents) from 10 Danish municipalities in the region of Southern Denmark. All study procedures were carried out in the home of the participants. Enrollment began on June 6, 2019, and ended on March 30, 2021. This analysis was conducted between January 1 and November 30, 2023. Families were randomly allocated to a screen media reduction group or a control group. The 2-week screen media reduction intervention was designed to ensure a high level of compliance to the reduction in leisure-time screen media use. Participants allocated to the intervention group had to reduce their leisure-time screen media use to 3 hours per week or less per person and hand over smartphones and tablets. The main outcome was the between-group mean difference in change in total behavioral difficulties, measured by the Strengths and Difficulties Questionnaire at 2-week follow-up. Results were estimated using mixed-effects tobit regression models. Analyses were carried out as both intention to treat and complete case. In the sample of 89 families including 181 children and adolescents (intervention group [45 families]: 86 children; mean [SD] age, 8.6 [2.7] years; 42 girls [49%]; control group [44 families]: 95 children; mean [SD] age, 9.5 [2.5] years; 57 girls [60%]), there was a statistically significant between-group mean difference in the total difficulties score, favoring the screen media reduction intervention (-1.67; 95% CI, -2.68 to -0.67; Cohen d, 0.53). The greatest improvements were observed for internalizing symptoms (emotional symptoms and peer problems; between-group mean difference, -1.03; 95% CI, -1.76 to -0.29) and prosocial behavior (between-group mean difference, 0.84; 95% CI, 0.39-1.30). This secondary analysis of a randomized clinical trial found that a short-term reduction in leisure-time screen media use within families positively affected psychological symptoms of children and adolescents, particularly by mitigating internalizing behavioral issues and enhancing prosocial behavior. More research is needed to confirm whether these effects are sustainable in the long term. ClinicalTrials.gov Identifier: NCT04098913.

Endobronchial Phenylephrine in Airway Bleeding During Bronchoscopy Does not Cause Hypertension: A Retrospective Observational Study.

Bleeding is a known complication during bronchoscopy, with increased incidence in patients undergoing a more invasive procedure. Phenylephrine is a potent vasoconstrictor that can control airway bleeding when applied topically and has been used as an alternative to epinephrine. The clinical effects of endobronchial phenylephrine on systemic vasoconstriction have not been clearly evaluated. Here, we compared the effects of endobronchial phenylephrine versus cold saline on systemic blood pressure. In all, 160 patients who underwent bronchoscopy and received either endobronchial phenylephrine or cold saline from July 1, 2017 to June 30, 2022 were included in this retrospective observational study. Intra-procedural blood pressure absolute and percent changes were measured and compared between the 2 groups. There were no observed statistical differences in blood pressure changes between groups. The median absolute change between the median and the maximum intra-procedural systolic blood pressure in the cold saline group was 29mmHg (IQR 19 to 41) compared with 31.8mmHg (IQR 18 to 45.5) in the phenylephrine group. The corresponding median percent changes in SBP were 33.6 % (IQR 18.8 to 39.4) and 28% (IQR 16.8 to 43.5) for the cold saline and phenylephrine groups, respectively. Similarly, there were no statistically significant differences in diastolic and mean arterial blood pressure changes between both groups. We found no significant differences in median intra-procedural systemic blood pressure changes comparing patients who received endobronchial cold saline to those receiving phenylephrine. Overall, this argues for the vascular and systemic safety of phenylephrine for airway bleeding as a reasonable alternative to epinephrine.

Is There a Relationship Between Grip Strength and Injuries in Professional Baseball Players?

Injuries in professional baseball players have become exceedingly common. Efforts to mitigate injury risk have focused on the kinetic chain, shoulder motion, and so forth. It is unclear whether grip strength is related to injury risk in professional baseball pitchers. The purpose of this study was to determine if grip strength was a risk factor for injury. It was hypothesized that pitchers with weaker grip strength would have a higher likelihood of sustaining a shoulder or elbow injury compared with pitchers with stronger grip strength. Case-control study; Level of evidence, 3. All professional pitchers from a single Major League Baseball organization were included. Dominant and nondominant grip strength were measured after each pitching outing throughout the 2022 season. Injuries over the course of the season were recorded, and data were compared between pitchers who sustained a shoulder or elbow injury and those who did not. Overall, 213 pitchers were included, of whom 53 (24.9%) sustained a shoulder or elbow injury during the season. The mean grip strength for all pitchers was 144.0 ± 20.8 lb (65.3 ± 9.4 kg). The mean dominant-arm grip strength was 142.6 ± 20.8 lb (64.7 ± 9.4 kg) for pitchers who did not sustain a shoulder or elbow injury and 148.2 ± 20.9 lb (67.2 ± 9.5 kg) for pitchers who did sustain an injury, with no significant group difference in grip strength (P > .05). Furthermore, there were no significant differences in change in grip strength over the course of the season between the groups. There was no significant difference in mean grip strength or change in grip strength over the course of a single season between professional baseball pitchers who sustained a shoulder or elbow injury and those who did not.