Usual Standard Of Care Research Articles

Extended lifetime expectancy in schizophrenia, role of measurement based care

Lifespan in schizophrenia spectrum disorders (SSD) is up to 20 years shorter than average. Introduction of new antipsychotic pharmaceuticals has not made any major improvement. Parallel care is provided as usual standard care (USD) in out-patients settings. The study aim was to evaluate if inclusion of Measurement Based Care (MBC) may prolong patients' lifespan. In total, 171 patients were followed with annual semi-structured examinations of psychiatric status, social situation, and somatic illnesses over 20 years, by case managers. Findings indicate that MBC contributed to prolonged lifespan in SSD from 55.6 to 69.4 years from beginning to end of the study.

How effective are non-pharmacological interventions for family caregivers? A systematic review with meta-analyses

Informal caregiving is associated with mental disorders and reduced quality of life. The aim of this systematic review was to summarize the results of methodologically high-quality intervention studies on the effectiveness of non-pharmacological interventions on patient-relevant outcomes for family caregivers in Germany. We searched three large scientific literature databases for intervention studies with a control group and a low or moderate risk of bias on the effectiveness of non-pharmacological interventions for family caregivers in Germany. Among 4,376 publications reviewed, 10 intervention studies with good methodological quality were identified. These investigated multi-component interventions or cognitive behavioral therapy for family caregivers of people with dementia (8 studies), stroke (1 study) and with general care dependency (1 study). The control groups received information material as a minimal intervention or usual standard care. Meta-analyses showed a statistically significant slight reduction in depressive symptoms 3-6 months after the start of the study as a result of cognitive behavioral therapy (standardized mean difference -0.27; 95% confidence interval -0.44 - -0.10), but this no longer reached statistical significance after 9-12 months (-0.21; -0.51 - 0.09). Multi-component interventions showed no changes in depressive symptoms either after 3-6 or after 9-12 months (-0.18; -0.40 - 0.03 and -0.14; -0.47 - 0.14, respectively). In contrast, the mental component of quality of life of family caregivers improved statistically significantly in the multi-component intervention groups compared to the control groups: slightly after 3-6 months (0.28; 0.01 - 0.56) and moderately after 9-12 months (0.45; 0.09 - 0.82). The interventions had no effect on the physical component of quality of life. The reduction of depressive symptoms by behavioral therapy interventions for family caregivers appears to be only slight and not sustainable. The mental component of quality of life of people affected may be improved in the longer term by multi-component interventions. Current scientifically examined interventions for informal caregivers do not appear to have a sufficient and sustainable effect. Greater effects could possibly be achieved through more elaborate behavioral approaches, but also structural preventive measures.

Individualized Cognitive Functional Therapy Compared with Conservative Treatment for Patients with Chronic Neck Pain-Study Protocol for a Single Blind Pragmatic Randomized Controlled Trial.

Chronic neck pain (CNP) is one of the most common musculoskeletal conditions, is considered the second leading cause of pain, and is among the leading causes of disability. Cognitive Functional Therapy (CFT) is a novel behavioral therapy for individualizing the management of spinal pain targeting the multidimensional aspect of musculoskeletal pain. This study outlines the protocol for an assessor-blind randomized controlled trial (RCT) designed to compare an individualized Cognitive Functional Therapy (CFT) intervention with usual care in terms of pain and disability. Aiming for a pragmatic intervention, the CFT group will receive 16 sessions based on patient's condition characteristics, and clinical presentation and progression. The control group will receive 16 sessions of standardized usual care (electrotherapy, massage, posture exercise, and educations). Both groups will have the same intervention duration. Patients will be randomly allocated into groups and will be assessed at baseline, at the 8th session, at the 16th session, and 3 months after randomization. Primary outcomes will be pain, disability, cervical range of motion, and neck muscle isometric strength. To our knowledge, this study will be the first RCT to compare the clinical effectiveness of CFT compared to UC for adults with CNP. The study results will provide information about the use of CFT in clinical practice.

Effects of pain education on disability, pain, quality of life, and self-efficacy in chronic low back pain: A randomized controlled trial.

Low back pain stands as a prevalent contributor to pain-related disability on a global scale. In addressing chronic low back pain (CLBP), there is a growing emphasis on incorporating psychological strategies into the management process. Among these, pain education interventions strive to reshape pain beliefs and mitigate the perceived threat of pain. This randomized controlled trial sought to assess the effects of pain education on various aspects, including pain levels, disability, quality of life, self-efficacy, and prognostic characteristics in individuals grappling with CLBP. The clinical trial, retrospectively registered with the Clinical Trials Registry of India (CTRI/2021/08/035963), employed a two-arm parallel randomized design. Ninety-two participants with CLBP were randomly assigned to either the standard physiotherapy care with a pain education program or the control group. Both groups underwent a 6-week intervention. Assessment of pain intensity (using NPRS), disability (using RMDQ), self-efficacy (using the general self-efficacy scale), and well-being (using WHO 5I) occurred both before and after the 6-week study intervention. Post-intervention score comparisons between the groups revealed that the pain education intervention led to a significant reduction in disability compared to the usual standard care at 6 weeks (mean difference 8.2, p < 0.001, effect size Cohen d = 0.75), a decrease in pain intensity (mean difference 3.5, p < 0.001, effect size Cohen d = 0.82), and an improvement in the well-being index (mean difference 13.7, p < 0.001, effect size Cohen d = 0.58). The findings suggest that integrating a pain education program enhances the therapeutic benefits of standard physiotherapy care for individuals dealing with chronic LBP. In conclusion, the clinical benefits of pain education become apparent when delivered in conjunction with standard care physiotherapy during the management of chronic low back pain.

Impact of Vojta therapy combined with standard care on psychometric and functional parameters in patients with chronic lower back pain: a randomized controlled trial.

Chronic low back pain (LBP) is very common, resulting in functional deficits and significant socio-economic burden. Non-pharmacological treatments, such as physical-psychological therapy, are frequently utilized. Vojta therapy (VT) is a type of physical therapy that effectively enhances the automatic control of body posture. This study aimed to evaluate the effects of combining VT with the usual standard of care (USC) therapy on psychometric and functional parameters in patients with chronic LBP. A total of 148 patients diagnosed with chronic LBP were recruited and randomized into two groups: LBP-VT (n = 82) and LBP-USC (n = 66). Patients were assessed for demographic characteristics, comorbid conditions, clinical findings, health status, pain symptom scales, psychometric, and functional parameters. The LBP-VT group received VT in addition to USC and electrotherapy, while the LBP-USC group received only USC. Initial Hamilton Depression Scale assessments indicated moderate depression, which improved to mild depression post-treatment. The effect of the treatment on self-esteem was significant for the LBP-VT group and moderate for the LBP-USC group. Functional parameters improved in both groups, with the LBP-VT group having significantly better results. Combining VT with standard care, electrotherapy, and massage significantly improved posture, reduced depression associated with functional deficits, and enhanced self-esteem in patients with chronic LBP.

BENEFICIAL EFFECTS OF A COMBINED AEROBIC AND STRENGTH TRAINING PROGRAM IN PATIENTS WITH MOTOR NEURON DISEASE

INTRODUCTION &amp; AIMS Motor Neuron Disease (MND) is a neurodegenerative disease characterised by the progressive degeneration and death of motor neurons, which leads to a reduction in muscle strength and physical function. Although “Exercise as Medicine” is accepted for many diseases, the role of exercise in individuals with MND is still debated. The aim of this study was to evaluate the effect of a combined, moderate-intensity, aerobic and strength training program on aerobic capacities, strength and physical function in individuals with MND. METHODS Fifteen individuals with MND were randomly assigned to either a training (3 times/week for 12 weeks; TRAIN, n=8) or a control (continued their usual standard of care; CTRL, n=7) group. The peak aerobic capacity (VO2peak) and the maximal capacity of oxygen extraction (via Near-Infrared Spectroscopy) were evaluated during an incremental test to exhaustion on a cycle ergometer. The strength of both the lower- and upper-limb muscles was evaluated with a 1-Repetition Maximum (1RM) test on the leg press, leg extension, biceps curl, and vertical chest press. Participants also performed the “Timed Up and Go” test (TUG) and the 6-min walking test (6MWT). RESULTS The adherence to training was 86 ± 6%, and the satisfaction with the exercise program was 9.6 out of 10. VO2peak did not change significantly in both groups, but the maximal capacity of O2 extraction improved significantly in TRAIN (from 44 ± 3 to 67 ± 4%). In TRAIN, the 1RM for the leg press and leg extension increased significantly by 47 ± 8% and 50 ± 13%, respectively, while this parameter did not change in CTRL. While the 6MWT increased by 5% in TRAIN and decreased by 3% in CTRL, the change was not significant. CONCLUSION These preliminary results support the beneficial role of a combined aerobic and strength training program in individuals with MND.

Serratus Anterior Plane Blocks for Early Rib Fracture Pain Management

Rib fractures secondary to blunt thoracic trauma typically result in severe pain that is notoriously difficult to manage. The serratus anterior plane block (SAPB) is a regional anesthesia technique that provides analgesia to most of the hemithorax; however, SAPB has limited evidence for analgesic benefits in rib fractures. To determine whether the addition of an SAPB to protocolized care bundles increases the likelihood of early favorable analgesic outcomes and reduces opioid requirements in patients with rib fractures. This multicenter, open-label, pragmatic randomized clinical trial was conducted at 8 emergency departments across metropolitan and regional New South Wales, Australia, between April 12, 2021, and January 22, 2022. Patients aged 16 years or older with clinically suspected or radiologically proven rib fractures were included in the study. Participants were excluded if they were intubated, transferred for urgent surgical intervention, or had a major concomitant nonthoracic injury. Data were analyzed from September 2022 to July 2023. Patients were randomly assigned (1:1) to receive an SAPB in addition to usual rib fracture management or standard care alone. The primary outcome was a composite pain score measured 4 hours after enrollment. Patients met the primary outcome if they had a pain score reduction of 2 or more points and an absolute pain score of less than 4 out of 10 points. A total of 588 patients were screened, of whom 210 patients (median [IQR] age, 71 [55-84] years; 131 [62%] male) were enrolled, with 105 patients randomized to receive an SAPB plus standard care and 105 patients randomized to standard care alone. In the complete-case intention-to-treat primary outcome analysis, the composite pain score outcome was reached in 38 of 92 patients (41%) in the SAPB group and 18 of 92 patients (19.6%) in the control group (relative risk [RR], 0.73; 95% CI, 0.60-0.89; P = .001). There was a clinically significant reduction in overall opioid consumption in the SAPB group compared with the control group (eg, median [IQR] total opioid requirement at 24 hours: 45 [19-118] vs 91 [34-155] milligram morphine equivalents). Rates of pneumonia (6 patients [10%] vs 7 patients [11%]), length of stay (eg, median [IQR] hospital stay, 4.2 [2.2-7.7] vs 5 [3-7.3] days), and 30-day mortality (1 patient [1%] vs 3 patients [4%]) were similar between the SAPB and control groups. This randomized clinical trial found that the addition of an SAPB to standard rib fracture care significantly increased the proportion of patients who experienced a meaningful reduction in their pain score while also reducing in-hospital opioid requirements. http://anzctr.org.au Identifier: ACTRN12621000040864.

A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS)

BackgroundDespite the fundamental progress in hematopoietic stem cell transplant, this treatment is also associated with complications. Graft-versus-host disease is a possible complication of HSCT. Bronchiolitis obliterans syndrome (BOS) is the pulmonary form of this syndrome. Due to the high morbidity and mortality rate of BOS, various studies have been conducted in the field of drug therapy for this syndrome, although no standard treatment has yet been proposed. According to the hypotheses about the similarities between BOS and chronic obstructive pulmonary disease, the idea of using tiotropium bromide as a bronchodilator has been proposed.Method/designA randomized, double-blind, placebo-controlled, and crossover clinical trial is being conducted to evaluate the efficacy of tiotropium in patients with BOS. A total of 20 patients with BOS were randomly assigned (1:1) to receive a once-daily inhaled capsule of either tiotropium bromide (KP-Tiova Rotacaps 18 mcg, Cipla, India) or placebo for 1 month. Patients will receive tiotropium bromide or placebo Revolizer added to usual standard care. Measurements will include spirometry and a 6-min walking test.Ethics/disseminationThis study was approved by the Research Ethics Committees of Imam Khomeini Hospital Complex, Tehran University of Medical Science. Recruitment started in September 2022, with 20 patients randomized. The treatment follow-up of participants with tiotropium is currently ongoing and is due to finish in April 2024. The authors will disseminate the findings in peer-reviewed publications, conferences, and seminar presentations.Trial registrationIranian Registry of Clinical Trial (IRCT) IRCT20200415047080N3. Registered on 2022–07-12, 1401/04/21.

Effectiveness of asfotase alfa for treatment of adults with hypophosphatasia: results from a global registry

BackgroundHypophosphatasia (HPP) is a rare inherited disease caused by deficient activity of tissue-nonspecific alkaline phosphatase. Many adults with HPP have a high burden of disease, experiencing chronic pain, fatigue, limited mobility, and dental issues, contributing to decreased health-related quality of life (HRQoL). HPP may be treated with the enzyme replacement therapy asfotase alfa though real-world data in adults are limited. This analysis was conducted to assess the clinical effectiveness of asfotase alfa among adults in the Global HPP Registry.MethodsThe Global HPP Registry is an observational, prospective, multinational study. Adults ≥ 18 years of age were included in this analysis if they had serum alkaline phosphatase (ALP) activity below the age- and sex-adjusted reference ranges, and/or ALPL variant(s), and received asfotase alfa for ≥ 6 months. Mobility was assessed with the 6-Minute Walk Test (6MWT), and patient-reported outcomes tools were used to assess pain (Brief Pain Inventory-Short Form), quality of life (36-item Short Form Health Survey, version 2 [SF-36v2]), and disability (Health Assessment Questionnaire-Disability Index) at multiple time points from baseline through Month 36. Data were collected as per usual standard of care; patients may not have contributed data at all time points.ResultsA total of 190 patients met the inclusion criteria. For patients with ≥ 1 follow-up measurement, the mean distance achieved on 6MWT increased from 404 m (range 60–632 m) at baseline (n = 31) to 484 m at Month 12 (range 240–739 m; n = 18) and remained above baseline through Month 36 (n = 7). Improvements in mean self-reported pain severity scores ranged from − 0.72 (95% CI: − 1.23, − 0.21; n = 38) to − 1.13 (95% CI: − 1.76, − 0.51; n = 26) and were observed at all time points. Improvements in the Physical Component Summary score of SF-36v2 were achieved by Month 6 and sustained throughout follow-up. There was a trend toward improvement in the Mental Component Summary score of SF-36v2 at most time points, with considerable fluctuations from Months 12 (n = 28) through 36 (n = 21). The most frequent adverse events were injection site reactions.ConclusionsAdults with HPP who received asfotase alfa for ≥ 6 months experienced improvements in mobility, physical function, and HRQoL, which were maintained over 3 years of follow-up.Registration: NCT02306720; EUPAS13514.

The effectiveness of short mobile phone text message reminders compared to usual care on medication adherence in patients with hypertension: a systematic review protocol

BackgroundPoor adherence to long-term medication increases the risk of morbidity and mortality and decreases the quality of life of patients with hypertension. One strategy to improve treatment adherence is to use a short text message reminder. Although evidence indicates that such programs increase medication adherence, the extent of their effectiveness and translation into clinical practice needs to be better documented. Our systematic review will collect and analyze the available evidence for clinical practice implementation. This systematic review aimed to evaluate the effectiveness of short mobile phone text message reminders versus usual/standard care for medication adherence in patients with hypertension.MethodsThis review will include and summarize evidence from randomized controlled trials. Adults (age > 18 years) with hypertension. The comparator group received either the usual care or standard care. It encompasses standard medical care for patients not participating in a structured and supervised intervention program such as a telemedicine program.We will include studies that assess the effectiveness of short mobile phone text message reminders in improving medication adherence in patients with hypertension compared to usual care. We will search the following databases: PubMed, EMBASE, CINAHL, SCOPUS, Web of Science, Cochrane Library Central Register of Controlled Trials, and Cochrane Library. We will include studies published in English. Furthermore, we will consider studies published from the inception of the database until April 20, 2024. At least two reviewers will independently conduct study selection, data extraction, and quality assessment. A third reviewer will determine and resolve discrepancies. We will conduct a quality assessment using the ROBIS 2 critical appraisal checklist. At least two independent reviewers will crosscheck the data synthesis.DiscussionWe expect this review to provide current evidence for future studies and clinical practice concerning the impact of mobile phone text message reminders on medication adherence issues. We will publish our results in a peer-reviewed journal for publication.Systematic review registrationPROSPERO CRD42023391236.

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome.

Efficacy of melatonin in decreasing the incidence of delirium in critically ill adults: a randomized controlled trial.

To determine whether enteral melatonin decreases the incidence of delirium in critically ill adults. In this randomized controlled trial, adults were admitted to the intensive care unit and received either usual standard care alone (Control Group) or in combination with 3mg of enteral melatonin once a day at 9 PM (Melatonin Group). Concealment of allocation was done by serially numbered opaque sealed envelopes. The intensivist assessing delirium and the investigator performing the data analysis were blinded to the group allocation. The primary outcome was the incidence of delirium within 24 hours of the intensive care unit stay. The secondary outcomes were the incidence of delirium on Days 3 and 7, intensive care unit mortality, length of intensive care unit stay, duration of mechanical ventilation and Glasgow outcome score (at discharge). We included 108 patients in the final analysis, with 54 patients in each group. At 24 hours of intensive care unit stay, there was no difference in the incidence of delirium between Melatonin and Control Groups (29.6 versus 46.2%; RR = 0.6; 95%CI 0.38 - 1.05; p = 0.11). No secondary outcome showed a statistically significant difference. Enteral melatonin 3mg is not more effective at decreasing the incidence of delirium than standard care is in critically ill adults.

The PRO-HOME Project. A multicomponent intervention for the protected discharge from the hospital of multimorbid and polytreated older individuals by using innovative technologies: A pilot study.

Discharge planning from the hospital of frail older patients is an important step to avoid inappropriate long-stay hospitalizations and to prevent the risks related to the prolonged hospitalization. In this frame, we developed an experimental trial-'PRO-HOME', a multicomponent programme of interventions for multimorbid and polytreated hospitalized older patients. The main aim of the study was to develop a protected discharge facility using a mini apartment equipped with advanced architectural and technological components to reduce the length of hospital stay of older participants (aged 65+ years old) admitted to the hospital for an acute event, deemed stable and dischargeable. This is a pilot randomized controlled study, comparing 30 hospitalized participants included in a multidimensional, transitional care programme based on information and communication technologies to 30 patients in standard usual care until hospital discharge. We presented the study design of the PRO-HOME programme, including architectural and technological components, the enrolment procedures, the components of the intervention that is physical activity, cognitive training and life-style education and the evaluation method of the intervention based on the Comprehensive Geriatric Assessment to explore the changes in the individual domains that are target of the multicomponent intervention. The final results will suggest whether the PRO-HOME programme represents a useful and feasible intervention to reduce the length of hospital stay of multimorbid and polytreated hospitalized older patients and improve their physical and cognitive performances and overall quality of life. Due to the characteristics of the population of interest of the PRO-HOME study, we involved in the study design and programme of the activities the participants enrolled in a previous smart home-based project named MoDiPro carried-out during a 3-year period. The elderly participants from the local population involved were asked, by means of focus groups, for feedback on their experience in MoDiPro, and their suggestions were integrated into the design phase of the current PRO-HOME project. The focus groups included open group interviews with a qualitative collection of the patients' feedback so that the participants could interact with each other.

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Empagliflozin has been proposed as a treatment for COVID-19 on the basis of its anti-inflammatory, metabolic, and haemodynamic effects. The RECOVERY trial aimed to assess its safety and efficacy in patients admitted to hospital with COVID-19. In the randomised, controlled, open-label RECOVERY trial, several possible treatments are compared with usual care in patients hospitalised with COVID-19. In this analysis, we assess eligible and consenting adults who were randomly allocated in a 1:1 ratio to either usual standard of care alone or usual standard of care plus oral empagliflozin 10 mg once daily for 28 days or until discharge (whichever came first) using web-based simple (unstratified) randomisation with allocation concealment. The primary outcome was 28-day mortality; secondary outcomes were duration of hospitalisation and (among participants not on invasive mechanical ventilation at baseline) the composite of invasive mechanical ventilation or death. On March 3, 2023 the independent data monitoring committee recommended that the investigators review the data and recruitment was consequently stopped on March 7, 2023. The ongoing RECOVERY trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Between July 28, 2021 and March 6, 2023, 4271 patients were randomly allocated to receive either empagliflozin (2113 patients) or usual care alone (2158 patients). Primary and secondary outcome data were known for greater than 99% of randomly assigned patients. Overall, 289 (14%) of 2113 patients allocated to empagliflozin and 307 (14%) of 2158 patients allocated to usual care died within 28 days (rate ratio 0·96 [95% CI 0·82-1·13]; p=0·64). There was no evidence of significant differences in duration of hospitalisation (median 8 days for both groups) or the proportion of patients discharged from hospital alive within 28 days (1678 [79%] in the empagliflozin group vs 1677 [78%] in the usual care group; rate ratio 1·03 [95% CI 0·96-1·10]; p=0·44). Among those not on invasive mechanical ventilation at baseline, there was no evidence of a significant difference in the proportion meeting the composite endpoint of invasive mechanical ventilation or death (338 [16%] of 2084 vs 371 [17%] of 2143; risk ratio 0·95 [95% CI 0·84-1·08]; p=0·44). Two serious adverse events believed to be related to empagliflozin were reported: both were ketosis without acidosis. In adults hospitalised with COVID-19, empagliflozin was not associated with reductions in 28-day mortality, duration of hospital stay, or risk of progressing to invasive mechanical ventilation or death so is not indicated for the treatment of such patients unless there is an established indication due to a different condition such as diabetes. UK Research and Innovation (Medical Research Council) and National Institute of Health Research (MC_PC_19056), and Wellcome Trust (222406/Z/20/Z). For the Nepali, Hindi, Indonesian (Bahasa) and Vietnamese translations of the abstract see Supplementary Materials section.

Side effects screening and early intervention to impact in quality of life of patients with gynecological cancers (HALIS study)

BackgroundAdvances in the treatment of gynecological cancers have led to increased survival in patients with gynecological cancers. Nevertheless, patients may still experience prevalent long term consequences, including lower limb lymphedema,...

Effects of a prenatal mindfulness program on longitudinal changes in stress, anxiety, depression, and mother–infant bonding of women with a tendency to perinatal mood and anxiety disorder: a randomized controlled trial

BackgroundStress is a risk factor for poor physical and mental health, affecting new mothers’ ability, especially those with perinatal mood and anxiety disorders, to maintain their everyday lives. Over the past 50 years, global incidences of depression and anxiety disorders have increased, reaching pandemic levels. These incidences represent major public health issues that are challenging to detect and treat. Mindfulness programs are viable for reducing stress, anxiety, and depression. The present study evaluates mindfulness intervention effects on stress, anxiety, depression, and mother–infant bonding.MethodsWe collected data on 102 women participating in a prenatal mindfulness program between July 2021 and March 2022; they were parallel and randomly assigned to experimental or control groups. The intervention group received an 8-week course in a prenatal mindfulness program, and the control group received usual standard prenatal care. The self-reported stress, pregnancy-related anxiety, and depression were assessed before and after the intervention and at 36 weeks of gestation. At 2 and 4 months postpartum, all participants provided self-reported their levels of stress, depression, and quality of mother-infant bonding.ResultsCompared to the control group, the experimental group that received the prenatal mindfulness intervention experienced reduced prenatal stress, anxiety, and depression and reduced postnatal stress and depression. Despite this, there was no significant difference between the groups in terms of the quality of mother-infant bonding.ConclusionsMindfulness prenatal programs are convenient and effective methods of decreasing stress, anxiety, and depression during the perinatal period. Based on our findings, prenatal mindfulness may play a role in mitigating mood and anxiety disorders and should be considered in future approaches to preventing psychological distress.Trial registration numberThis trial has been prospectively registered at ClinicalTrials.gov (NCT04693130) and the first registration date was 12/24/2020.

Promoting early childhood development in Viet Nam: cost-effectiveness analysis alongside a cluster-randomised trial

Economic evaluations are critical to ensure effective resource use to implement and scale up child development interventions. This study aimed to estimate the cost-effectiveness of a multicomponent early childhood development intervention in rural Viet Nam. We did a cost-effectiveness study alongside a cluster-randomised trial with a 30-month time horizon. The study included 669 mothers from 42 communes in the intervention group, and 576 mothers from 42 communes in the control group. Mothers in the intervention group attended Learning Clubs sessions from mid-pregnancy to 12 months after delivery. The primary outcomes were child cognitive, language, motor, and social-emotional development at age 2 years. In this analysis, we estimated the incremental cost-effectiveness ratios (ICERs) of the intervention compared with the usual standard of care from the service provider and household perspectives. We used non-parametric bootstrapping to examine uncertainty, and applied a 3% discount rate. The total intervention cost was US$169 898 (start-up cost $133 692 and recurrent cost $36 206). The recurrent cost per child was $58 (1 341 741 Vietnamese dong). Considering the recurrent cost alone, the base-case ICER was $14 and mean ICER of 1000 bootstrap samples was $14 (95% CI -0·48 to 30) per cognitive development score gained with a 3% discount rate to costs. The ICER per language and motor development score gained was $22 and $20, respectively, with a 3% discount rate to costs. The intervention was cost-effective: the ICER per child cognitive development score gained was 0·5% of Viet Nam's gross domestic product per capita, alongside other benefits in language and motor development. This finding supports the scaling up of this intervention in similar socioeconomic settings. Australian National Health and Medical Research Council and Grand Challenges Canada. For the Vietnamese translation of the abstract see Supplementary Materials section.

Effectiveness of Telerehabilitation in Persons With Spinal Cord Injury During the COVID-19 Pandemic (TELE-SCOPE): A Single-Center, Double-Blind, Randomized Controlled Trial.

Introduction The COVID-19 pandemic has posed numerous challenges in accessing adequate healthcare services, particularly for individuals with spinal cord injury (SCI). On the other hand, telerehabilitation has emerged as a promising solution to address healthcare needs. Since there was no study during the pandemic, we started this study with the aim of assessing the efficacy of telerehabilitation for individuals with SCI during the COVID-19 pandemic. Methods This is a prospective double-blind, randomized, controlled trial conducted in a tertiary rehabilitation care center hospital. Thirty participants with traumatic spinal cord injuries (age 18 years or more, either gender) were equally randomized to the telerehabilitation or control group (1:1). Biweekly telerehabilitation sessions (each session: 30 minutes) were provided. Participants in the control group were advised to continue standard usual care as advised previously during outpatient or inpatient rehabilitation. The Spinal Cord Independence Measure (SCIM III) (primary outcome measure) and Coronavirus Anxiety Scale (CAS) (secondary outcome measure) were evaluated at baseline, four weeks, and eight weeks. Results The mean age of the intervention group was 28.2±6.9 years, and the mean age of the control group was 26.3±7.7 years. The self-care (P = 0.03) and mobility domains (P=0.01) of the SCIM III in the intervention group compared to the control group, as determined through a between-group analysis, showed statistically significant differences. CAS also showed improvement in the intervention group compared to the control group. Within-group analysis showed a mean difference of 6.3 points in the intervention group compared to the control group (1.3 points). Conclusion Telerehabilitation intervention is safe, feasible, and effective in improving self-care and mobility domains in persons with spinal cord injuries during the pandemic. It is also effective in reducing the anxiety related to the coronavirus in this population. Further research with a larger sample size and a longer duration is needed to evaluate long-term effectiveness during such crises.

The Impact of Measurement-Based Care in Psychiatry: An Integrative Review.

The quality of mental health treatment has not progressed to the same extent as physical health treatment. Suboptimal mental health outcomes may be attributed to the lack of a systematic approach to tracking and measuring patient progress. In psychiatry, Measurement-Based Care (MBC) offers an objective, systematic approach to monitor clinical progress, evaluate treatment efficacy, and inform clinical decisions, yet remains seldom used in daily practice. To identify the clinical impact of using MBC in psychiatry. Using the Johns Hopkins Nursing Evidence-Based Practice Model as a guideline, this integrative review focused on the research query, "What is the clinical impact of Measurement-Based Care when treating patients with mental illness?" A total of nine articles met the inclusion criteria for this integrative review. The articles ranged from 2008 to 2021. The following themes were identified from the analysis of these articles: (1) the clinical impact of MBC, (2) provider attitudes about MBC, and (3) barriers to MBC implementation. MBC, augmenting usual standard care, provides an objective, systematic approach using quantifiable data to monitor symptom severity and treatment effectiveness. This review highlights the clinical benefits of MBC, including increased remission rates, lower risk of relapse, improved medication adherence, and strengthening the therapeutic alliance. Although this review provides an overview of the benefits of MBC in psychiatry, there remains a substantial practice gap warranting further investigation. Strategies must be developed to address barriers at the individual and organizational levels which impede the successful adoption of MBC.

Higher dose corticosteroids in patients admitted to hospital with COVID-19 who are hypoxic but not requiring ventilatory support (RECOVERY): a randomised, controlled, open-label, platform trial

Low-dose corticosteroids have been shown to reduce mortality for patients with COVID-19 requiring oxygen or ventilatory support (non-invasive mechanical ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation). We evaluated the use of a higher dose of corticosteroids in this patient group. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing multiple possible treatments in patients hospitalised for COVID-19. Eligible and consenting adult patients with clinical evidence of hypoxia (ie, receiving oxygen or with oxygen saturation <92% on room air) were randomly allocated (1:1) to either usual care with higher dose corticosteroids (dexamethasone 20 mg once daily for 5 days followed by 10 mg dexamethasone once daily for 5 days or until discharge if sooner) or usual standard of care alone (which included dexamethasone 6 mg once daily for 10 days or until discharge if sooner). The primary outcome was 28-day mortality among all randomised participants. On May 11, 2022, the independent data monitoring committee recommended stopping recruitment of patients receiving no oxygen or simple oxygen only due to safety concerns. We report the results for these participants only. Recruitment of patients receiving ventilatory support is ongoing. The RECOVERY trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Between May 25, 2021, and May 13, 2022, 1272 patients with COVID-19 and hypoxia receiving no oxygen (eight [1%]) or simple oxygen only (1264 [99%]) were randomly allocated to receive usual care plus higher dose corticosteroids (659 patients) versus usual care alone (613 patients, of whom 87% received low-dose corticosteroids during the follow-up period). Of those randomly assigned, 745 (59%) were in Asia, 512 (40%) in the UK, and 15 (1%) in Africa. 248 (19%) had diabetes and 769 (60%) were male. Overall, 123 (19%) of 659 patients allocated to higher dose corticosteroids versus 75 (12%) of 613 patients allocated to usual care died within 28 days (rate ratio 1·59 [95% CI 1·20-2·10]; p=0·0012). There was also an excess of pneumonia reported to be due to non-COVID infection (64 cases [10%] vs 37 cases [6%]; absolute difference 3·7% [95% CI 0·7-6·6]) and an increase in hyperglycaemia requiring increased insulin dose (142 [22%] vs 87 [14%]; absolute difference 7·4% [95% CI 3·2-11·5]). In patients hospitalised for COVID-19 with clinical hypoxia who required either no oxygen or simple oxygen only, higher dose corticosteroids significantly increased the risk of death compared with usual care, which included low-dose corticosteroids. The RECOVERY trial continues to assess the effects of higher dose corticosteroids in patients hospitalised with COVID-19 who require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation. UK Research and Innovation (Medical Research Council), National Institute of Health and Care Research, and Wellcome Trust.