Randomized Controlled Trials Research Articles

Safety and Efficacy of Chyawanprash as a Prophylaxis Treatment for COVID-19: A Systematic Review and Meta-Analysis of Randomized Control Trials

Safety and Efficacy of Chyawanprash as a Prophylaxis Treatment for COVID-19: A Systematic Review and Meta-Analysis of Randomized Control Trials

The Eczema Bathing Study: Weekly versus daily bathing for people with eczema? Protocol of an online, randomised controlled trial

Background A priority setting partnership for eczema (syn atopic eczema, atopic dermatitis) has identified that bathing frequency is a key area of patient interest. However, there are nolarge, high-quality randomised controlled trials (RCTs) investigating this. The Rapid Eczema Trials project is a novel programme of research that aims to deliver multiple online RCTs, using a citizen science approach. This project involves working with members of the public to co-design and conduct studies that answer questions of importance to them. The first trial to be conducted through this project is assessing the impact of bathing frequency on eczema. Methods This is an online, two-arm, parallel-group superiority RCT with internal pilot phase. People aged ≥1 year with eczemaliving in the United Kingdom are eligible. Exclusion criteria are: people with other types of eczema such as venous eczema, hand eczema and contact eczema; recently started a new eczema treatment; taking part in another eczema trial; Patient Oriented Eczema Measure (POEM) ≤2; planning to swim more than twice a week; unable/unwilling to change bathing practices. Participants are allocated 1:1 to either the weekly bathing group (bathe 1 or 2 times a week) or the daily bathing group (bathe 6 or more times a week) for 4 weeks. The primary outcome is POEM, assessed weekly over 4 weeks. Secondary outcomes include skin specific quality of life, eczema control, itch severity, use of usual eczema treatments, proportion who achieve an improvement in POEM of ≥3 points, global change in eczema and safety outcomes. A sample of participants will also be invited to a semi-structured interview to discuss their experience. The primary comparative analysis will be according to randomised allocation regardless of actual frequency of bathing. The trial will be reported in accordance with CONSORT guidelines. The study has received ethical approval by the London - Surrey Research Ethics Committee (2 Redman Place, London, E20 1JQ, United Kingdom) on 11/10/2023 ( approval number: 23/PR/0899). Trial registration ISRCTN12016473, 22/11/2023, https://doi.org/10.1186/ISRCTN12016473

Best practice guide for patellofemoral pain based on synthesis of a systematic review, the patient voice and expert clinical reasoning

ObjectiveDefine a best practice guide for managing people with patellofemoral pain (PFP).MethodsA mixed-methods convergent segregated synthesis of meta-analysed data with a thematic analysis of semistructured interviews and focus groups. Agreement...

The efficacy and safety of intravenous tocilizumab to treat Graves' ophthalmopathy: A systematic review and single-arm meta-analysis.

This study aims to evaluate the efficacy and safety of intravenous tocilizumab (TCZ) in the treatment of Graves' ophthalmopathy (GO). A comprehensive search was conducted across the Web of Science, PubMed, Embase, Cochrane Library, World Health Organization International Clinical Trials Registry Platform, and https://ClinicalTrials.gov databases from inception to April 2024. Randomized controlled trials (RCTs) and cohort studies that utilized intravenous TCZ for treating GO were included. Twelve studies encompassing 219 patients with active, steroid-resistant GO were analyzed. The meta-analysis demonstrated significant improvements in Clinical Activity Score (CAS) response (effect size [ES] = 0.98, 95% confidence interval [CI]: 0.93-1.00), proptosis response (ES = 0.50, 95% CI: 0.27-0.73), and diplopia response (ES = 0.48, 95% CI: 0.24-0.74). The ES for adverse events was 0.27 (95% CI: 0.22-0.33), with only three severe cases necessitating treatment discontinuation, and a low reactivation rate (ES = 0.01, 95% CI: 0.00-0.04). TCZ treatment led to a mean CAS reduction of 4.60 points (95% CI: 3.88-5.32) across 10 studies, a mean proptosis reduction of 2.04 mm (95% CI: 1.42-2.65) across 7 studies, and a mean decrease in thyroid-stimulating hormone receptor antibodies (TRAb) levels of 10.62 IU (95% CI: 4.67-10.62) across 5 studies. This meta-analysis provides robust evidence supporting the efficacy and safety of intravenous TCZ in patients with GO who are resistant to glucocorticoid therapy. The results highlight TCZ's comparable efficacy to glucocorticoids and suggest that TCZ could significantly expand clinical management options for GO. In the future, more high-quality, large-scale RCTs are still needed to confirm these findings.

Cryotherapy for Rehabilitation After Total Knee Arthroplasty: A Comprehensive Systematic Review and Meta-Analysis.

Despite being well-studied and widely utilized, the efficacy of cryotherapy after total knee arthroplasty (TKA) in enhancing early rehabilitation lacks consensus. The aim of this systematic review and meta-analysis was to investigate (1) whether cryotherapy is able to promote the rehabilitation of patients undergoing TKA and (2) whether continuous cold flow device has superior results than cold pack in cryotherapy. A comprehensive trial searching was performed in the PubMed, Embase, Cochrane Library, and Google Scholar electronic databases in May, 2024. Randomized controlled trials (RCTs) comparing cryotherapy with no cryotherapy or comparing continuous cold flow device with cold pack after TKA were included. The primary outcome was visual analogue scale (VAS) of pain, and secondary outcomes included opioid consumption, blood loss (hemoglobin decrease and drainage), range of motion (ROM), swelling, length of stay (LOS), and adverse event. A total of 31 RCTs were included in this meta-analysis with 18 trials comparing cryotherapy with no cryotherapy and 13 trials comparing continuous cold flow device with cold pack. Pooled results showed cryotherapy group had significantly lower VAS scores than no cryotherapy group on postoperative day (POD) 1 (MD, -0.59 [95% CI, -1.14 to -0.04]; p = 0.04), POD 2 (MD, -0.84 [95% CI, -1.65 to -0.03]; p = 0.04), and POD 3 (MD, -0.86 [95% CI, -1.65 to -0.07]; p = 0.03). Cryotherapy group also showed reduced opioid consumption, reduced hemoglobin loss, decreased drainage, and improved ROM after TKA. Continuous cold flow device group had comparable VAS, opioid consumption, blood loss, ROM, knee swelling, and LOS with cold pack group. Cryotherapy can effectively alleviate postoperative pain, reduce blood loss, improve ROM, and thus promote the postoperative rehabilitation for TKA patients, but the continuous cold flow device did not show better efficacy than cold packs. These findings support the routine use of cryotherapy for the rapid rehabilitation of TKA patients, and the traditional cold pack is still recommended.

Breast cancer and neoplasms of the thyroid gland: a bidirectional two-sample Mendelian randomization study.

With the rising incidence of breast cancer (BC) and neoplasms of the thyroid gland, a potential link between the two has drawn increasing attention. However, the causal relationship remains unclear due to various confounding factors. This study aims to investigate the causality between BC and thyroid tumors using Mendelian Randomization (MR) analysis. We conducted a bidirectional two-sample MR analysis, utilizing breast cancer-associated single nucleotide polymorphisms (SNPs) from the Breast Cancer Association Consortium (BCAC) and thyroid tumor-related SNPs from the FinnGen (https://www.finngen.fi/) database. First, we performed univariable MR (UVMR) to assess the causal relationship between BC and both malignant and benign thyroid tumors, followed by reverse causality analysis. To account for potential confounders, we applied multivariable MR (MVMR). The inverse-variance weighted (IVW) method was primarily used, with secondary analyses performed using the weighted median and MR-Egger regression approaches. UVMR analysis revealed a significant positive causal relationship between BC and malignant thyroid tumors (odds ratio [OR] and 95% confidence interval [CI]: 1.291, 1.143-1.458, P = 3.90×10-5). No causal relationship was found between BC and benign thyroid tumors. The MVMR analysis, adjusting for confounding factors such as smoking, drinking, and body mass index (BMI), confirmed the robustness of the results. This study provides genetic evidence supporting a causal relationship between BC and malignant thyroid tumors. These findings highlight the importance of thyroid cancer screening in BC patients. However, further MR studies or randomized controlled trials (RCTs) are necessary to assess small effects accurately.

Efficacy and Safety of Cardiac Myosin Inhibitors in Hypertrophic Cardiomyopathy: A Meta-Analysis of Randomized Controlled Trials

Hypertrophic cardiomyopathy (HCM) is a genetic cardiac disorder characterized by structural and functional abnormalities. Current management strategies, such as medications and septal reduction therapies, have significant limitations and risks. Recently, cardiac myosin inhibitors (CMIs) like mavacamten and aficamten have shown promise as noninvasive treatment options. This meta-analysis aims to evaluate the efficacy and safety of CMIs in HCM patients. PubMed/MEDLINE, Embase, the Cochrane Library, Ovid, and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) that compared CMIs to control treatments in HCM patients from inception till June 15, 2024. A random-effects model was used to pool odds ratios (ORs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes along with the corresponding 95% confidence intervals (CIs). Heterogeneity was assessed using the χ2 test and Higgins I 2 statistic, and sensitivity and subgroup analyses were performed. Six RCTs involving 826 patients were included. CMI therapy significantly reduced resting left ventricular outflow tract (LVOT) gradient (MD, −37.64; 95% CI, −46.71 to −28.56), Valsalva LVOT gradient (MD, −46.04; 95% CI, −57.60 to −34.48), post-exercise LVOT peak gradient (MD, −48.64; 95% CI, −68.20 to −28.88), N-terminal pro-b-type natriuretic peptide levels (MD, −1.05; 95% CI, −1.64 to −0.47), and cardiac troponin I levels (MD, −7.96; 95% CI, −12.84 to −3.07). Improvements were observed in peak oxygen consumption (MD, 1.20; 95% CI, 0.23–2.17) and patient-reported outcomes (Kansas City Cardiomyopathy Questionnaire Clinical Summary Score: MD, 6.44; 95% CI, 3.50–9.37), with more patients achieving New York Heart Association class improvement >1 (OR, 4.05; 95% CI, 2.61–6.30). Treatment-emergent adverse events were higher with CMI therapy (OR, 1.45; 95% CI, 1.02–2.05), but serious adverse events and other safety outcomes were comparable in both groups. CMIs, including mavacamten and aficamten, significantly improve clinical outcomes in HCM patients with a manageable safety profile. These results indicate that CMIs offer a promising noninvasive alternative to septal reduction therapies.

Exercise effects on neuropsychiatric symptoms and quality of life in mild cognitive impairment: a systematic review and meta-analysis.

Exercise is considered as a cost-efficient option for individuals with mild cognitive impairment (MCI). Although the potential benefits of exercise for improving cognitive function are recognized, its impact on neuropsychiatric symptoms (NPS) and the quality of life (QoL) in individuals with MCI remains unclear. This study aims to investigate the effects of exercise interventions on NPS, including depression, anxiety, sleep disorders, and the quality of life in individuals with MCI. There were 17 randomized controlled trials (RCTs) involving 1,575 participants were included. The findings indicate a small but significant positive effect of exercise on depression (standardized mean difference [SMD] = -0.47, 95% confidence interval [CI]: -0.73 to -0.21), but the quality of the evidence is low. Mind-body exercises were relatively more effective in alleviating depression. No significant improvements were observed in sleep disorders (SMD = -1.27, 95% CI: -2.80 to 0.26). Exercise improved anxiety in one study but had no effect in the other. It also improved quality of life in seven studies, with two showing no effect. The findings suggest that exercise, particularly mind-body exercises, can improve depression in individuals with MCI. However, the effect of exercise on anxiety, sleep disorders, and quality of life is still uncertain, necessitating additional research. These findings underscore the significance of integrating customized exercise programs in managing MCI to boost quality of life and mitigate NPS. https://www.crd.york.ac.uk/prospero/. ID: CRD42023445369.

Efficacy and safety of immunotherapy combined with chemotherapy in patients with ES-SCLC: A systematic review and network meta-analysis of RCTs and RWSs.

To evaluate the efficacy and safety of programmed cell death 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitors in the treatment of extensive-stage small-cell lung cancer (ES-SCLC), we conducted a systematic review and meta-analysis that included randomized controlled trials (RCTs) and real-world studies (RWS). By scanning PubMed, Web of science, Embase, and other relevant clinical information public databases, nine RCTs and eight RWSs involving 5205 patients were included in the study. We directly compared the differences between chemotherapy and PD-1/PD-L1 inhibitors plus chemotherapy, and determined the optimal treatment strategy through network meta-analysis (NMA). Compared to chemotherapy, the addition of PD-1/PD-L1 inhibitors significantly improves the overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) in SCLC patients. Regarding safety, both RCTs and RWSs indicated no significant difference in grade 3-4 adverse events between chemotherapy and chemoimmunotherapy. NMA showed serplulimab plus chemotherapy (Serp_Chemo) appears to provide the best OS, PFS, and ORR benefit, while nivolumab plus chemotherapy shows higher toxicity than other regimens. In subgroup analysis, for elderly patients (age ≥65) and non-elderly (age <65) patients, the most promising quality regimens for achieving better OS extension are atezolizumab plus chemotherapy (Atez_Chemo) and Serp_Chemo, respectively. For patients with PD-L1 ≥ 1% and lactate dehydrogenase (LDH) > upper limit of normal (ULN), there is no apparent OS benefit from immune therapy. In ES-SCLC treatment, adding PD-1/PD-L1 inhibitors to standard chemotherapy improves OS, PFS, and ORR, with Serp_Chemo shows the most promise. Atez_Chemo and Serp_Chemo provided better survival for elderly and non-elderly patients, respectively.

Effectiveness and safety of polyethylene-glycol-4000 versus sodium picosulphate plus magnesium oxide and citric acid for bowel cleansing before colonoscopy in children: A systematic review with meta-analysis.

Colonoscopy is performed for diagnostic and therapeutic purposes. The quality of colonoscopy depends on adequate bowel cleansing. However, there is no standardized protocol for bowel preparation in children. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to estimate the effectiveness, safety, and tolerability profile of polyethylene glycol (PEG) compared with those of sodium picosulfate (SPMC) in children. The primary sources of the reviewed studies were Scopus, PubMed, and Cochrane Library. The databases were systematically searched for RCTs comparing PEG 4000 to SPMC as a bowel cleansing solution. Six studies were included. The analysis showed that both PEG and SPMC are effective for bowel cleansing, while a split-dose regimen may be preferable to a day-before one. There were no differences between the two groups regarding adverse events such as abdominal pain, nausea, vomiting, bloating, and anal discomfort. Additionally, preparation with SPMC was preferred in terms of acceptability and compliance. Still, the need to place a nasogastric tube was significantly lower in the SPMC group compared to the PEG group and in the split dose regimen compared to the day before. In conclusion, PEG and SPMC are equally effective in obtaining an adequate bowel cleansing with a comparable adverse event rate; moreover, split-dose administration may be preferable to day-before one in terms of effective bowel cleansing. However, SPMC preparation is more acceptable seems to result in higher compliance, and to reduce the use of a nasogastric tube, that we encounter daily in clinical practice, is perceived as a stressful experience for children and their families.

Assessment of the Efficacy of Deep Brain Stimulation (DBS) in Managing Drug-Resistant Epilepsy (DRE): A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs)

Assessment of the Efficacy of Deep Brain Stimulation (DBS) in Managing Drug-Resistant Epilepsy (DRE): A Systematic Review and Meta-Analysis of Randomized Controlled Trials (RCTs)

Analysis of the outcomes in treatment of ulcerative colitis with acupuncture and moxibustion

To clarify the key outcomes of acupuncture-moxibustion treatment of ulcerative colitis. The clinical randomized controlled trials (RCTs) for ulcerative colitis treated with acupuncture and moxibustion were searched from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science, from the inception of each database to March 20th, 2023. The basic information of literature, intervention measures and outcome indexes were collected. The selection of primary and secondary outcomes, the use frequency of each index and the combination of them in utility were analyzed; and index domains of acupuncture and moxibustion for ulcerative colitis were summarized. A total of 215 RCTs were included and 54 outcomes were involved, classified into 6 categories, i.e. TCM syndromes, symptoms/physical signs, physical and chemical tests, quality of life, long-term prognosis and safety events. The top 3 outcomes with high use frequency were clinical effect evaluation, adverse reactions of acupuncture and moxibustion and the score of main symptoms. Only 3 articles clearly reported the primary outcome and the secondary ones, 180 articles used two types of outcomes simultaneously, 3 articles clearly described the time points of the observation indexes, and 126 articles determined the sources of the evaluation criteria of therapeutic effect, with 57 criteria involved. At present, the outcomes have not been standardized in RCTs of acupuncture and moxibustion for ulcerative colitis. It needs to clarify the primary one and the secondary ones. The criteria have not been unified for the evaluation of therapeutic effects and there is less consideration on the quality of life in patients, the follow-up visit and safety events. The attention should be paid to develop the outcome set, in which, the endoscopic score is taken as the objective, and the improvements in the symptoms/physical signs and the biochemical examination as the supplementary.

Interventions for Adjunctive Care in Patients With Inflammatory Bowel Disease and Permanent Ileostomy: A Systematic Review.

The evidence for the management of patients with Crohn's disease (CD) and permanent ileostomy (PI) is limited. We aimed to summarize the interventional studies related to the provision of adjunctive ostomy care in this population. MEDLINE, Embase, and Cochrane CENTRAL were searched from inception to January 5, 2024. Eligible studies were non-randomized or randomized controlled trials (RCTs), or comparative cohort studies predominantly recruiting participants with CD and/or ulcerative colitis (UC) with PI assessing interventions for the management of high stoma output, disease recurrence, peristomal skin care, pouching systems, behavioral interventions, mental health support, and diet. Out of 3217 records, 6 were eligible and all were RCTs (n = 95). Out of these, 5 adopted a crossover design, and 1 study was a double-blind parallel-group RCT. All except 1 were published more than 20 years ago (1976-2003). Two studies exclusively included patients with UC, one included CD, and the remaining included both UC and CD. Four studies assessed pharmacological interventions (loperamide, 5-aminosalysilate [5-ASA], azodisal sodium, and budesonide), one assessed oral supplement with different osmolarities, and one assessed dietary intervention (unrefined vs refined carbohydrate). A decrease in ileostomy output was the primary outcome of interest in 4 studies. None of the studies assessed interventions for peristomal skin care, quality of life, stoma pouching systems, behavioral interventions, mental health, or CD recurrence. This study highlights that the evidence base to inform care for patients with IBD and PI is almost non-existent. There is an urgent need for focused research in this area to inform evidence-based treatment decisions.

Newer Therapies for Refractory Helicobacter pylori Infection in Adults: A Systematic Review.

Helicobacter pylori (H. pylori) infection is a global health concern, affecting approximately two-thirds of the world's population. Standard first-line treatment regimens often fail, necessitating alternative rescue therapies. This review aims to evaluate the efficacy and safety of newer treatment regimens in patients who have failed initial H. pylori eradication therapy. A comprehensive literature search was conducted in PubMed, the Cochrane Library, and Embase. Inclusion criteria were randomized controlled trials (RCTs) published after 2010, involving patients with previous H. pylori treatment failure and interventions with vonoprazan-based therapy, high-dose PPI-amoxicillin dual therapy (HDDT), or rifabutin-containing triple therapy. 10 RCTs were included. HDDT demonstrated high eradication rates (81.3% to 89.2%), particularly when combined with metronidazole (92.6%), although at an increased frequency of adverse events. Vonoprazan-based regimens achieved comparable or higher eradication rates (83.3% to 89.5%) compared to PPI-based therapies, with similar adverse events. Rifabutin-containing triple therapy showed high efficacy (80.7% to 100%), particularly in patients with a history of multiple treatment failures, and it was associated with lower adverse events compared to bismuth-containing regimens. HDDT, vonoprazan-based therapy, and rifabutin-based therapy have proven to be effective and safe rescue regimens for treating H. pylori infection. Additional large-scale randomized studies are needed to determine the optimal doses and durations of these regimens to achieve the highest eradication rate with the lowest incidence of adverse events among patients with refractory H. pylori infections globally.

Redesigning a Stopped Clinical Trial as an Emulated Trial Using Real-World Data to Explore the Effectiveness of Slow-Release Oral Morphine as a Treatment for Opioid Use Disorder.

Canada is currently experiencing a problematic opioid crisis with increasing mortality rates. Traditional randomized controlled trials (RCTs) that examine the effectiveness of pharmacological treatment options for people with opioid use disorder (OUD) are challenging to conduct. An increasingly popular methodology is through the implementation of emulated clinical trials, a methodology in which key elements of a "target" RCT are replicated using previously collected healthcare-based data. They can possibly address some of the common challenges found in the conduct of RCTs, such as prolonged timelines, high cost, and poor participant recruitment. In effect, emulated trials accelerate knowledge generation by producing real-world evidence that can be akin to phase 3 effectiveness trials, without any need to recruit live participants or administer investigational products. During the COVID-19 pandemic, several trials were stopped due to increased pandemic-related research restrictions, leaving important questions about OUD treatment unanswered. In this commentary, we describe the transition of a traditional RCT to an emulated trial spurred by challenges posed by the COVID-19 pandemic. We describe our transition using a notable published framework with regards to the population sample, interventions, outcomes, and proposed analyses. This commentary aims to help other researchers and trialists apply emulated trials in substance use research and beyond, emphasizing the role of this methodology in clinical research and advancing scientific knowledge that could be otherwise lost or unattainable.

Impact of resistance training on fatigue among breast cancer patients undergoing chemotherapy: a systematic review and meta-analysis.

The effects of aerobic exercise interventions for reducing fatigue after cancer treatment are well-established, and the effect of resistance training remains uncertain. Therefore, this systematic review and meta-analysis aim to analyze the effect of resistance training and combined resistance and endurance training on cancer-related fatigue (CRF) in breast cancer patients. A systematic search for randomized controlled trials (RCTs) was conducted on the PubMed, SPORTDiscus, Embase, and Cochrane databases, focusing on the effect of supervised resistance training and combined supervised resistance and endurance training on CRF. Random-effect models were employed for calculating the standardized mean difference (SMD). Risk of bias was assessed with risk of bias 2 (RoB2), and certainty of evidence was judged according to the GRADE approach. A total of 9 RCTs with 1512 participants were included, and data from 866 participants in 8 RCTs were used for the meta-analysis. The risk of bias was deemed low in seven studies, while one study exhibited attrition bias, and one showed possible selection bias. Resistance training probably reduce the total fatigue (SMD= -0.30, 95% CI -0.52, -0.08, p=0.008), with individual studies showing small effects on physical and emotional CRF. A combined resistance and endurance training reduce total fatigue (SMD= -0.34, 95% CI -0.51, -0.17, p= 0.0001), with individual studies indicating moderate effects on physical fatigue, in daily life fatigue, and small effects on emotional and cognitive CRF. Both supervised resistance training and combined resistance and endurance training have a small effect on total CRF. There is a trend towards an influence of intensity, with higher intensity potentially resulting in lower total CRF.

Effectiveness of Integrated Care for Older Pepole (ICOPE) in Improving Intrinsic Capacity in Older Adults: A Systematic Review and Meta-Analysis.

Conduct a systematic review of existing studies on intrinsic capacity (IC) and a meta-analysis of studies to assess the overall effectiveness of ICOPE in improving IC in older adults. Ten databases were systematically searched from inception to November 8, 2023, and the search was last updated on January 2, 2024. Randomised controlled trials (RCTs) were included. The main outcomes were IC (cognition, psychological, sensory, vitality and locomotion). The results showed ICOPE had a significant effect in improving cognitive function (SMD = 0.36; 95% CI, 0.17 to 0.56, p < 0.001, 12 RCTs, 7926 participants) and depressive symptoms (SMD = -0.70; 95% CI, -0.96 to -0.43, p < 0.001, 26 RCTs, 11,034 participants), but there was no statistically significant difference in improving locomotion (SMD = 0.16; 95% CI, -0.03 to 0.34, p = 0.098, 3 RCTs, 1580 participants). Meta-regression analysis shows that intervention duration should be paid attention to when the source of heterogeneity is discussed on the cognition. The results suggest that ICOPE may be a potentially effective approach to help improve the IC in older adults, showing significant potential for improving cognitive function and reducing depressive symptoms in particular. ICOPE is expected to provide effective strategies to enhance issues such as IC and may be an innovative way to improve the overall health of older adults. This result provides strong support for geriatric nursing practice and encourages the adoption of ICOPE as a viable nursing approach to promote healthy ageing.

Assessment of outcomes in Crohn's disease: A systematic review of randomized clinical trials to inform a multiple outcome framework.

Longstanding disease control in Crohn's disease (CD) is challenging and requires understanding treatment efficacy and outcomes assessment. With multiple novel therapeutic options, rigorous evaluation of outcomes in randomized controlled trials (RCTs) is crucial to inform clinical practice. This study systematically reviewed RCTs focusing on CD outcomes to elucidate the breadth and depth of reported outcomes and measurement instruments. A systematic search was conducted on MEDLINE and Scopus for RCTs published from 1 January 2000 to 31 January 2023. Eligible studies included full-text articles with at least 50 adult CD patients. Primary and secondary outcomes, along with their measurement instruments, were categorized according to the Outcome Measures in Rheumatology Filter 2.1 framework. From 88 included studies, 393 outcomes were analyzed. Clinical outcomes, such as clinical remission and response, were the most prevalent (50.6%); biomarkers (11.5%) and patient-reported outcomes (10.2%) were also assessed. Other outcomes included disease behavior and complications (2%), endoscopy (10.4%), histology (0.5%), radiology (1.3%), healthcare utilization (3.8%), and therapy-related safety (6.9%). Composite outcomes showed an increasing trend, reflecting a shift toward comprehensive evaluations. Coprimary endpoints, including clinical symptoms and mucosal inflammation, were reported in 21 of 88 studies. This review highlights the evolving landscape of outcome assessment in CD RCTs, emphasizing the increasing complexity of outcomes. The prominence of composite outcomes underscores efforts to capture the multidimensional nature of CD. These findings will inform the second stage of a two-round e-Delphi aimed at prioritizing key domains and outcomes for developing a multiple-component outcome for RCTs in CD research.

Mobile applications for promoting and supporting breastfeeding: Systematic review and meta-analysis.

Breastfeeding practices require improvement. We performed a systematic review of randomised controlled trials (RCTs) and analytic observational studies to assess effects of mobile applications (apps) aiming to support and promote breastfeeding targeting pregnant women, mothers of infants or their partners, on breastfeeding outcomes. We searched MEDLINE, EMBASE, Cochrane CENTRAL and Association of Computing Machinery Digital Library from 1 July 2008 to 29 November 2022, with lack of coverage of the most recent period before publication date being a limitation of this review. We performed meta-analyses of findings from RCTs on primary outcomes, namely early breastfeeding initiation, exclusive and any breastfeeding rates. Joanna Briggs Institute tools were used for risk of bias assessment. Six RCTs, one quasi-experimental and two cohort studies, mainly from high-income countries, were included. Most studies focused on maternal app usage starting from pregnancy. One study targeted fathers as app-users. Population characteristics, such as parity or delivery mode, apps scope of content and applied active components varied between studies. Main methodological limitations of studies were baseline differences between groups and lack of blinding. Compared to controls, app usage tended to increase the odds of exclusive breastfeeding. This nonsignificant effect was most pronounced at 1-1.5 months (n = 1294, odds ratio 1.45 (95% Confidence Interval, CI 0.83, 2.54), with considerable heterogeneity between studies [I2 77%]), but less so at 3 and 6 months post-partum. The odds of early breastfeeding initiation, any breastfeeding at all time points were similar among groups. However, two cohort studies reported increased odds of exclusive and/or any breastfeeding at different time points. In conclusion, evidence is insufficient to show sustained beneficial effects of breastfeeding promotion and support through mobile apps on breastfeeding rates.

Pancreatitis in Patients with Cancer Receiving Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis.

Immune checkpoint inhibitors (ICIs) occasionally cause immune-related adverse events (AEs), which pose challenges to the continuation of treatment. Although ICIs are widely used in patients with cancer, studies reporting immune-mediated pancreatitis remain scarce. We performed a systematic review and meta-analysis to address current knowledge gaps and provide clinical guidance for ICI-associated pancreatitis and lipase elevation. We searched PubMed/Medline, Embase, and Web of Science for phase 3 randomized controlled trials (RCTs) evaluating ICIs. The incidence of any-grade and grade 3-5 pancreatitis/lipase elevation was calculated. Then, we performed a random-effect model meta-analysis to pool the odds ratios (ORs) of these outcomes using RCTs evaluating the addition of an ICI to systemic therapy to assess the effect of ICIs on pancreatic AEs. A systematic review of the treatment of ICI-related pancreatitis was also conducted. The incidence analysis included 81 articles (79 RCTs) comprising 36,871 patients. The incidence of treatment-related pancreatitis was 0.68% (any-grade) and 0.32% (grade 3-5). Meta-analysis revealed that the addition of ICI therapy significantly increased any-grade (OR 2.12, 95% confidence interval [CI] 1.45-3.11, p < 0.001) and grade 3-5 pancreatitis (OR 1.76, 95% CI 1.01-3.08, p < 0.05) with low heterogeneity among ICI subtype subgroups (any-grade: I2 = 0%, p = 0.99; grade 3-5: I2 = 0%, p = 0.63). In analysis of treatment outcome among 146 patients from 53 articles, glucocorticoids were used in 80.6% (n = 108/134) and ICIs were discontinued in 76.5% (n = 101/132; permanent discontinuation: 62.5% [n = 35/56]). The overall rate of pancreatitis appears low, but the addition of ICI therapy significantly increased the incidence of pancreatitis. These findings provide insight into the incidence and treatment of pancreatitis associated with ICIs.