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Psychiatry Research Oct 2023Our meta-analysis demonstrated that intermittent theta burst stimulation (iTBS)/bilateral-TBS (Bi-TBS) and high-frequency repetitive transcranial magnetic stimulation... (Meta-Analysis)
Meta-Analysis
Our meta-analysis demonstrated that intermittent theta burst stimulation (iTBS)/bilateral-TBS (Bi-TBS) and high-frequency repetitive transcranial magnetic stimulation (HF-rTMS)/bilateral-rTMS (Bi-rTMS) had similar efficacy, acceptability, and safety profiles for antidepressant treatment-resistant major depressive disorder (AD-TRD). In our sensitivity analysis that excluded a study that compared Bi-TBS with Bi-rTMS for older adults, all efficacy outcomes were also comparable between iTBS and HF-rTMS. Because iTBS does not require higher stimulation intensity and a longer stimulus time than conventional HF-rTMS protocols, we speculated that for those with AD-TRD, iTBS/Bi-TBS is a more helpful therapeutic modality in clinical practice than HF-rTMS/Bi-rTMS.
Topics: Humans; Aged; Depressive Disorder, Major; Transcranial Magnetic Stimulation; Depressive Disorder, Treatment-Resistant; Antidepressive Agents; Treatment Outcome
PubMed: 37657200
DOI: 10.1016/j.psychres.2023.115452 -
Journal of Ethnopharmacology Apr 2024Many researchers have adopted resolving phlegm and unblocking fu-organs (RPUF) therapy for acute ischemic stroke (AIS) patients and yielded beneficial results in terms... (Meta-Analysis)
Meta-Analysis Review
ETHNOPHARMACOLOGICAL RELEVANCE
Many researchers have adopted resolving phlegm and unblocking fu-organs (RPUF) therapy for acute ischemic stroke (AIS) patients and yielded beneficial results in terms of clinical symptoms. However, there has been no systematically pooled analysis of RPUF therapy for AIS to date. Therefore, a well-designed systematic review and meta-analysis is necessary.
AIM
This systematic review aims to determine the efficacy and safety of traditional Chinese medicine (TCM) therapy for resolving phlegm and unblocking fu-organs (RPUF) for the treatment of acute ischemic stroke (AIS).
METHODS
Eight databases were searched to identify eligible randomized controlled trials (RCTs) involving RPUF therapy for AIS. The primary outcome included the modified Rankin Scale (mRS), and the secondary outcomes were the National Institute of Health Stroke Scale (NIHSS), the Neurological Deficit Score (NDS), Barthel Index (BI), Fugel-Meyer assessment (FMA), and the Glasgow Coma Scale (GCS). The Cochrane Handbook for Systematic Reviews of Interventions was used to assess risk of bias. The quantitative synthesis was analyzed using RevMan 5.3 and Stata 14.0 software.
RESULTS
The systematic review and meta-analysis comprised 61 RCTs with a total of 6056 participants. RPUF prescriptions combined with usual care were superior to usual care alone in individuals with AIS, as evidenced by decreased mRS (MD=-0.34; 95%CI [-0.65, -0.03]; P=0.03), NIHSS (MD=-3.38; 95%CI [-4.07, -2.68]; P<0.00001), and NDS (MD=-3.65; 95%CI [-4.07, -3.24]; P<0.00001), as well as improved BI (MD=10.4; 95%CI [8.21, 12.59]; P<0.00001), FMA (MD=20.41; 95%CI [17.40, 23.41]; P<0.00001), and GCS (MD=3.08; 95%CI [1.95, 4.20]; P<0.00001). No significant difference was observed in the incidence of adverse effects between the RPUF therapy group and the usual care group.
CONCLUSION
RPUF therapy appears to be an effective and safe approach for treating AIS; it could decrease mRS, NIHSS, and NDS while improving BI, FMA, and GCS. However, the methodological quality of the included RCTs was far from sufficient, and further high-quality, well-designed RCTs with long-term follow-up are still required.
Topics: Humans; Ischemic Stroke; Medicine, Chinese Traditional; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 38160868
DOI: 10.1016/j.jep.2023.117660 -
European Journal of Cancer (Oxford,... Aug 2023Many immuno-oncology (IO) trials are conducted without biomarker selection. We performed a meta-analysis of phase I/II clinical trials evaluating immune checkpoint... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many immuno-oncology (IO) trials are conducted without biomarker selection. We performed a meta-analysis of phase I/II clinical trials evaluating immune checkpoint inhibitors (ICIs) to determine the association between biomarkers and clinical outcomes, if any.
METHODS
A PubMed search for phase I/II clinical trials with drugs approved by the Food and Drug Administration (labelled, off-label, combined with investigational ICIs or other treatment modalities) from 2018 to 2020 was performed. The objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) were compared between biomarker-positive and biomarker-negative groups, using studies that explored the correlation of biomarkers with outcomes.
RESULTS
Overall, 174 clinical studies that included 19,178 patients were identified, and 132 studies investigated>30 correlative biomarkers that included PD-L1 expression (≥1%, 111 studies), tumour mutational burden (20 studies) and microsatellite instability/mismatch repair deficiency (10 studies). Overall, 123, 46 and 30 cohorts (drugs, tumour types or biomarkers) with 11,692, 3065, and 2256 patient outcomes for ORR, PFS and OS, respectively, were analysed in correlation with biomarkers. Meta-analyses demonstrated that ICIs in patients with biomarker-positive tumours were associated with higher ORR (odds ratio 2.15 [95% CI, 1.79-2.58], p < 0.0001); and longer PFS (hazard ratio [HR] 0.55 [95% CI, 0.45-0.67], p < 0.0001), and OS (HR 0.65 [95% CI, 0.53-0.80], p < 0.0001) compared with those with biomarker-negative tumours. Significance for ORR and PFS was retained in multivariate analysis (p < 0.001) (OS, not included owing to the small number of trials reporting OS).
CONCLUSION
Our data suggest that IO biomarkers should be used in patient selection for ICIs. Prospective studies are warranted.
Topics: Humans; Neoplasms; Treatment Outcome; Immunotherapy; Biomarkers; Progression-Free Survival
PubMed: 37364526
DOI: 10.1016/j.ejca.2023.05.015 -
Nutrients Mar 2024People are increasingly encouraged to reduce animal food consumption and shift towards plant-based diets; however, the implications for children's health are unclear. In... (Review)
Review
People are increasingly encouraged to reduce animal food consumption and shift towards plant-based diets; however, the implications for children's health are unclear. In this narrative review of research in high-income settings, we summarize evidence on the increasing consumption of plant-based diets in children and update an earlier systematic review regarding their associations with children's health outcomes. The evidence indicates that vegan, but not vegetarian, diets can restrict growth relative to omnivorous children and increase the risk of being stunted and underweight, although the percentage affected is relatively small. Bone mineral content is reduced in vegetarian and, in particular, vegan children, compared to omnivores. Both vegetarian and vegan children who do not use vitamin B12 supplements manifest with B12 deficiency; however, supplementation rectifies this problem. Both vegetarians and vegans have lower concentrations of 25(OH)D if unsupplemented, and lower body iron stores, but usually have normal iron metabolism markers. Both groups are at risk of iodine deficiency, and this might affect thyroid health. Children consuming a vegan diet have a more favorable lipid profile than omnivorous children; however, the results for a vegetarian diet are inconsistent and vary by outcome. Based on the same scientific evidence, national and international dietary recommendations are heterogeneous, with some countries supporting plant-based diets among infants, children, and adolescents, and others discouraging them. We offer a research roadmap, highlighting what is needed to provide adequate evidence to harmonize dietary recommendations for plant-based diets in children. A number of measures should urgently be introduced at international and national levels to improve the safety of their use in children.
Topics: Child; Infant; Adolescent; Animals; Humans; Diet, Plant-Based; Diet; Diet, Vegetarian; Vegetarians; Diet, Vegan; Iron; Outcome Assessment, Health Care
PubMed: 38474851
DOI: 10.3390/nu16050723 -
Journal of Plastic, Reconstructive &... May 2024Face transplant (FT) has emerged as a groundbreaking option for patients with severe facial deformities, resulting from congenital disorders, trauma, or tumor ablation.... (Review)
Review
Face transplant (FT) has emerged as a groundbreaking option for patients with severe facial deformities, resulting from congenital disorders, trauma, or tumor ablation. Although reconstructive surgery has made significant strides, the challenges of restoring both form and function remain, particularly in centrally located defects. This review explored the long-term outcomes of FT, addressing its challenges and potential pitfalls. A systematic review following the PRISMA guidelines was conducted, encompassing articles published in English from November 2005 to January 2023, which were searched across PubMed, MEDLINE, and EMBASE databases. Keywords included "face transplant," "face transplant outcomes," and "face transplant long-term." Data on surgical teams, patient demographics, transplant specifics, rejection episodes, additional surgeries, and patient-reported outcomes were extracted and analyzed. In total, 34 articles met the inclusion criteria. Over the 2 decades, 48 FT procedures were performed, with 23 patients followed for at least 3 years. Predominantly, patients were men (80%), averaging 31 years in age. Ballistic trauma (44.6%) and burns (25.5%) were common causes of injury. Chronic rejection emerged as a significant concern, leading to graft loss and necessitating retransplantation in 2 patients. Additional surgical procedures were often required. FT offers a remarkable solution for individuals with extensive facial disfigurement. Successful outcomes depend on factors, such as patient selection, multidisciplinary collaboration, psychiatric evaluation, and post-operative care. Nevertheless, challenges persist, including the need for lifelong immunosuppression and risk of chronic rejection. Although FT has transformed lives, continued success in this evolving field hinges on the ongoing research and vigilant patient management.
Topics: Humans; Facial Transplantation; Graft Rejection; Facial Injuries; Treatment Outcome
PubMed: 38513344
DOI: 10.1016/j.bjps.2024.02.064 -
JBJS Reviews Jul 2023The purpose of this systematic review and meta-analysis was to evaluate various outcomes of humeral shaft fractures treated with different treatment methods, which... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The purpose of this systematic review and meta-analysis was to evaluate various outcomes of humeral shaft fractures treated with different treatment methods, which included functional bracing, open reduction and internal fixation, intramedullary nailing, and locked compression plate.
METHODS
A systematic review was performed using research databases including PubMed, EMBASE, and Google Scholar. Keywords relating to treatment of humeral shaft fractures were used, and comparison studies that reported patient characteristics and outcomes, including nonunion, malunion, function scores, and complications, were included. One hundred fourteen records were screened, with 18 studies ultimately included in the meta-analysis. Treatment groups were consolidated into brace or surgery and then further categorized into subgroups based on surgical technique used. Postoperative events, complications, and functional scores were compared among the treatment groups. Statistical analysis for this study was conducted using Review Manager 5.3, with a standard p-value of ≤0.05 for statistical significance.
RESULTS
Eighteen studies were included in this review with a total of 706 patients. Z-tests showed that risks of revision, nonunion, and malunion were higher in the brace treatment group compared with the surgical treatment group (p < 0.0001, <0.0001, 0.004, respectively). Risk of infection was expectedly higher in the surgical group compared with the brace group (p = 0.04). Radial nerve injury rates were also higher in the unspecified surgical group compared with the brace group (p = 0.01). In the surgical group, the mean Constant shoulder score was also significantly higher than that in the brace group (p = 0.004). When comparing the nail and plate groups, Z-tests revealed higher risks of delayed unions and other complications in the nail group (p = 0.04 and 0.001, respectively) but higher risk of infection in the plate group (p = 0.05).
CONCLUSION
The conservative treatment of humeral shaft fractures with functional braces may be associated with a lower incidence of infection and nerve injury when compared with operative treatment methods. However, nonoperative treatment may also come with higher risks of revision, nonunion, and malunion than the many available surgical modalities. Operative management with either intramedullary nail or plate has shown to be a reliable method of management with reasonable outcomes for humeral shaft fractures. While the nail group had higher risk of delayed unions and other complications, the plate group had higher risk of infections. Both nail and plate surgical treatments have shown to result in high union rates and should be considered by the surgeon on a case-by-case basis when treating humeral shaft fractures.
LEVEL OF EVIDENCE
Level I. See Instructions for Authors for a complete description of levels of evidence.
Topics: Humans; Treatment Outcome; Humeral Fractures; Fracture Fixation, Internal; Humerus; Bone Plates
PubMed: 37459427
DOI: 10.2106/JBJS.RVW.23.00037 -
Journal of Clinical Nursing Sep 2023While nurse-sensitive outcomes (NSOs) are well established in numerous health settings, to date there is no indicator suite of NSOs for inpatient mental health settings. (Review)
Review
BACKGROUND
While nurse-sensitive outcomes (NSOs) are well established in numerous health settings, to date there is no indicator suite of NSOs for inpatient mental health settings.
AIM
To assess the relationship between nursing variables and patient outcomes in acute inpatient mental health settings to determine which outcomes can be used as indicators of the quality of nursing care.
METHODS
Databases accessed were CINAHL, MEDLINE, PsycINFO and EMBASE, last searched in May 2022. The review followed the 2020 PRISMA checklist for systematic reviews. Papers published between 1995 and 2022, conducted in acute mental health care units were included. The quality of the studies was assessed using the Effective Public Health Practice Project Quality Assessment Tool. A meta-analysis was not possible because of the large number of variables and measurement inconsistencies.
RESULTS
A total of 57 studies were reviewed. Studies were categorised according to whether they found a significant or non-significant relationship between nurse variables and patient outcomes. Seven outcomes-aggression, seclusion, restraint, absconding, pro-re-nata medications, special observations and self-harm-were identified. For each outcome, there were significant findings for several nurse variables indicating that all included outcomes could be used as NSOs. However, evidence for aggression, seclusion and restraint use as suitable NSOs was more robust than the evidence for self-harm, absconding, pro-re-nata medications and special observations.
CONCLUSION
All the seven outcomes can all be used to develop an NSO indicator suite in mental health inpatient settings. More work is needed to establish high-quality studies to clearly demonstrate the relationship between these outcome measures and changes in nurse variables such as nurse staffing, skill mix, work environment, nurse education and nurse experience.
PATIENT AND PUBLIC CONTRIBUTION
Patient or public contribution was not possible because of the type of the variables being explored.
Topics: Humans; Mental Health; Inpatients; Nursing Care; Outcome Assessment, Health Care; Personnel Staffing and Scheduling
PubMed: 36915223
DOI: 10.1111/jocn.16679 -
Clinical Neurology and Neurosurgery Aug 2023A variety of dietary adjuncts are known to affect the pathophysiology of glioma, making them a potential therapeutic adjunct to standard of care. We systematically... (Review)
Review
BACKGROUND
A variety of dietary adjuncts are known to affect the pathophysiology of glioma, making them a potential therapeutic adjunct to standard of care. We systematically reviewed clinical outcomes in glioma patients treated with one or more nutritional adjunct and/or an antimetabolite drug.
METHODOLOGY
A systematic review of the literature following PRISMA guidelines was performed using Pubmed from inception till February 2023. In total, 22 manuscripts on nutrition representing 828 patients were included in the review. Statistical analyses were performed to compare the outcomes of various adjuncts.
RESULTS
The median overall survival (OS) increased for newly diagnosed (21 months) and recurrent cases (10 months) when compared to historical data. For newly diagnosed cases, a ketogenic diet had the highest median OS of all the adjuncts (42.6 months) while in recurrent cases, a low copper diet coupled with 1 g penicillamine had the highest median OS (18.5 months). However, no statistically significant difference was observed in OS or progression-free survival (PFS) of newly diagnosed or recurrent gliomas.
CONCLUSION
While nutritional adjuncts may offer a therapeutic benefit in the treatment of glioma, more human subject research is needed to derive meaningful conclusions.
Topics: Humans; Neoplasm Recurrence, Local; Glioma; Progression-Free Survival; Brain Neoplasms
PubMed: 37390567
DOI: 10.1016/j.clineuro.2023.107853 -
European Urology Oct 2023In the oncology setting, patient-reported outcome measures (PROMs) provide important data that help to ensure patient-relevant endpoints are captured and reported. Use... (Review)
Review
CONTEXT
In the oncology setting, patient-reported outcome measures (PROMs) provide important data that help to ensure patient-relevant endpoints are captured and reported. Use of this information for treatment decision-making by clinicians and patients in real-world settings is facilitated by consistent and transparent reporting of trial methods.
OBJECTIVE
To identify and compare PROMs used in advanced renal cell carcinoma (RCC) trials in terms of the rationale for the choice of measure, endpoint hierarchy (primary, secondary, exploratory), assessment time points, statistical methods, and statistical metrics for interpretation.
EVIDENCE ACQUISITION
A systematic literature review via searches of four online databases (2016-2021) and recent conference abstracts (2019-2021) identified 2616 articles, of which 33 were included in the review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.
EVIDENCE SYNTHESIS
Among the 33 clinical studies included, 19 different PROMs were identified: three kidney cancer-specific scales, two cancer-specific scales, two generic scales, and 12 symptom-specific scales. The endpoint hierarchy for patient reported outcome (PRO) assessment was reported in 42% of the studies; one study included PROs as a primary endpoint. Reporting of time points, minimal important differences, and statistical analyses was highly heterogeneous.
CONCLUSIONS
A diverse range of PROMs have been included in clinical studies for patients with advanced/metastatic RCC. Prespecified analyses for PRO assessments were generally not stated, while analytical methods and reporting varied. An improvement in alignment across studies would better inform regulatory, market-access, reimbursement, and clinical decision-making to improve patient care.
PATIENT SUMMARY
We reviewed how the impact of cancer therapies on health outcomes from the patient's point of view is being measured in clinical trials for kidney cancer. The techniques and reporting varied across trials. Standardisation of how these data are captured and reported may improve care and decision-making for patients with kidney cancer.
Topics: Humans; Carcinoma, Renal Cell; Patient Reported Outcome Measures; Kidney Neoplasms; Patient Outcome Assessment; Research Design
PubMed: 37550153
DOI: 10.1016/j.eururo.2023.07.006 -
Trauma, Violence & Abuse Jan 2024The aim of this systematic review was to assess the magnitude of the association between types of intimate partner violence (IPV) and mental health outcomes and shed... (Meta-Analysis)
Meta-Analysis Review
The aim of this systematic review was to assess the magnitude of the association between types of intimate partner violence (IPV) and mental health outcomes and shed light on the large variation in IPV prevalence rates between low- to middle-income countries and high-income countries. The study is a systematic review and meta-analysis. The following databases were searched for this study: Cochrane, MEDLINE, EMBASE, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and the Applied Social Sciences Index and Abstracts. The inclusion criteria for this study are as follows: quantitative studies published from 2012 to 2020 on IPV exposure in women aged 16+, using validated measures. Random effects meta-analyses and subgroup analysis exploring heterogeneity across population groups in different economic contexts are used in this study. In all, 201 studies were included with 250,599 women, primarily from high-income countries. Higher prevalence rates were reported for women's lifetime IPV than past year IPV. Lifetime psychological violence was the most prevalent form of IPV. Women in the community reported the highest prevalence for physical, psychological, and sexual violence in the past year compared to clinical groups. Perinatal women were most likely to have experienced lifetime physical IPV. Prevalence rates differed significantly ( = .037 to <.001) for "any IPV" and all subtypes by income country level. Meta-analysis suggested increased odds for all mental health outcomes associated with IPV including depression (odds ratio [OR] = 2.04-3.14), posttraumatic stress disorder (PTSD) (OR = 2.15-2.66), and suicidality (OR = 2.17-5.52). Clinical and community populations were exposed to high prevalence of IPV and increased likelihood of depression, PTSD, and suicidality. Future research should seek to understand women's perspectives on service/support responses to IPV to address their mental health needs. Work with IPV survivors should be carried out to develop bespoke services to reduce IPV in groups most at risk such as pregnant and/or help-seeking women.
Topics: Pregnancy; Female; Humans; Prevalence; Intimate Partner Violence; Violence; Stress Disorders, Post-Traumatic; Outcome Assessment, Health Care
PubMed: 36825800
DOI: 10.1177/15248380231155529