Clinical Trial Quality Assessment in Adult Spinal Surgery: What Do Publication Status, Funding Source, and Result Reporting Tell Us?

Study Design Narrative Review Objectives The objective of this study was to compare publication status of clinical trials in adult spine surgery registered on ClinicalTrials.gov by funding source as well as to identify other trends in clinical trials in adult spine surgery. Methods All prospective, comparative, therapeutic (intervention-based) trials of adult spinal disease that were registered on ClinicalTrials.gov with a start date of January 1, 2000 and completion date before December 17, 2018 were included. Primary outcome was publication status of published or unpublished. A bivariate analysis was used to compare publication status to funding source of industry vs non-industry. Results Our search identified 107 clinical trials. The most common source of funding was industry (62 trials, 57.9% of total), followed by University funding (26 trials, 24.3%). The results of 76 trials (71.0%) were published, with industry-funded trials less likely to be published compared to non–industry-funded trials (62.9% compared to 82.2%, P = .03). Of the 31 unpublished studies, 13 did not report any results on ClinicalTrials.gov , and of those with reported results, none was a positive trial. Conclusions Clinician researchers in adult spine surgery should be aware that industry-funded trials are less likely to go on to publication compared to non–industry-funded trials, and that negative trials are frequently not published. Future opportunities include improvement in result reporting and in publishing negative studies.

Effect of Kangaroo Mother Care on the Likelihood of Breastfeeding from Birth up to 6 Months of Age: A Meta-analysis

Background. One of the World Health Organization (WHO) nutrition target by 2025 is 50% exclusive breastfeeding rate among infants until age 6 months. Kangaroo mother care (KMC) known to increase breastfeeding rates, especially in preterm and low birth weight (LBW) infants. Objectives. This study determined the effect of KMC to the rate of exclusive breastfeeding among preterm and LBW infants at 6 months of age. Methods. Conducted searches in MEDLINE and CENTRAL databases, likewise hand searched local publications December 1996 until June 2018. Included several randomized controlled trials and prospective observational studies comparing KMC and conventional care among preterm and LBW infants. The primary outcome was exclusive breastfeeding of infants at six months of age. Two authors independently assessed trial quality and extracted data the statistical analysis applied using Review Manager version 5.3. Results. Identified nine eligible trials involving 1,202 neonates. All studies had low-to-moderate risk of bias. KMC significantly noted to increase the likelihood of exclusive breastfeeding by 1.9 times at birth up to 6 months (OR 1.93 [1.18,3.17], p=0.009). Conclusion. KMC can increase exclusive breastfeeding among preterm and LBW infants from birth up to 6 months of age.

A Comparison of Chemotherapy Used with and without Apatinib for Patients with Ovarian Carcinoma Who Progressed after Standard Regimens: A Systematic Review and Meta-Analysis

Objective. This meta-analysis was conducted to compare the therapeutic efficacy and clinical safety of the combination therapy of apatinib plus chemotherapy with that of chemotherapy alone in patients with refractory or recurrent ovarian carcinoma (OC). Methods. Relevant randomized controlled trials (RCT) or case-control studies (CCS) were identified by searching Chinese and English databases up to October 31, 2020. The risk of methodological bias tool and Newcastle–Ottawa scale (NOS) were used to assess trial quality. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated to evaluate the therapeutic effects and adverse drug reactions. Subgroup analyses of study type, study sample size, dosage of apatinib, and chemotherapy regimen between treatment group and control group were performed. Publication bias was assessed by funnel plot symmetry, Begg–Mazumdar test, and Egger test. The robustness of our results was presented by removing the trial one by one. Results. Fifteen eligible studies covering 1,020 patients were included in this review and meta-analysis. Among these studies, 8 were RCTs, and 7 were CCSs. Compared with chemotherapy alone, apatinib plus chemotherapy significantly increased objective response rate (OR = 3.55; 95% CI 2.31 to 5.47), disease control rate (OR = 3.04; 95% CI 2.12 to 4.36), and overall survival (OR = 5.03; 95% CI 3.16 to 6.90). Conclusions. The combination treatment of apatinib plus chemotherapy provides better clinical benefits for OC patients when compared to chemotherapy alone and should be recommended for suitable patients with OC after the failure of standard regimens. However, further investigation into future large-scale prospective randomized research is still needed.

EFFICACY OF SPIRULINA FOR ALLERGIC RHINITIS

Introduction: Allergic rhinitis is a condition of high prevalence in the population and widely studied, with several treatments being consecrated for its control. Spirulina is a dietary supplement that modulates immune function, and has been shown to modulate the inflammatory response of allergic rhinitis. Purpose: To evaluate spirulina in the treatment and control of allergic rhinitis. Material and Methods: This is a systematic review of randomized clinical trials. Searches were performed for randomized clinical trials relating spirulina to allergic rhinitis in five electronic databases: Cochrane - Central Register of Controlled Trials - CENTRAL (2021), PUBMED (1966-2021), EMBASE (1974-2021), LILACS (1982-2021) AND SCOPUS (2021). Two investigators independently extracted data and assessed trial quality. Results: Two clinical trials involving a total of 215 patients were included. Both studies assessed the efficacy of spirulina in improving allergic rhinitis as the primary outcome. The first study described a significant reduction in runny nose, nasal congestion and itching over time of medication use (p 0.001) and in the second study the prevalence of rhinorrhea (P = 0.021), nasal congestion or obstruction (P = 0.039) and decreased smell (P = 0.030) were significantly less in the experimental group than in the control group. Conclusions: The included studies were in favor of the use of spirrulina. However, the level of evidence is very low and limited. We should have caution due to the small number of clinical trials and participants in these studies. It is recommended to carry out new RCTs following the CONSORT standardization.

Leveraging Blockchain Technology for Informed Consent Process and Patient Engagement in a Clinical Trial Pilot

Objective: Despite the implementation of quality assurance procedures, current clinical trial management processes are time-consuming, costly, and often susceptible to error. This can result in limited trust, transparency, and process inefficiencies, without true patient empowerment. The objective of this study was to determine whether blockchain technology could enforce trust, transparency, and patient empowerment in the clinical trial data management process, while reducing trial cost. Design: In this proof of concept pilot, we deployed a Hyperledger Fabric-based blockchain system in an active clinical trial setting to assess the impact of blockchain technology on mean monitoring visit time and cost, non-compliances, and user experience. Using a parallel study design, we compared differences between blockchain technology and standard methodology. Results: A total of 12 trial participants, seven study coordinators and three clinical research associates across five sites participated in the pilot. Blockchain technology significantly reduces total mean monitoring visit time and cost versus standard trial management (475 to 7 min; P = 0.001; €722 to €10; P = 0.001 per participant/visit, respectively), while enhancing patient trust, transparency, and empowerment in 91, 82 and 63% of the patients, respectively. No difference in non-compliances as a marker of trial quality was detected. Conclusion: Blockchain technology holds promise to improve patient-centricity and to reduce trial cost compared to conventional clinical trial management. The ability of this technology to improve trial quality warrants further investigation.

Efficacy of positive psychotherapy in reducing negative and enhancing positive psychological outcomes: a meta-analysis of randomised controlled trials

ObjectivePositive psychotherapy (PPT) aims at increasing positive affect, meaning and engagement. We aimed to synthesise the available evidence on PPT efficacy.DesignWe conducted a preregistered systematic literature search and meta-analysis of randomised controlled trials examining the efficacy of PPT for increasing positive (eg, satisfaction with life) or decreasing negative psychological outcomes (eg, depression).Data sourcesMedline, PsycINFO and Web of Science from 2006 (ie, inception of PPT) to February 2020 as well as related systematic reviews and meta-analyses.ResultsWe included 20 randomised controlled trial with a total of 1360 participants. Moderate effect sizes were found for increasing positive outcomes (g=−0.72, 95% CI: −1.31 to −0.14, k=10, numbers needed to treat (NNT)=2.55) and reducing negative outcomes (g=0.48, 95% CI: 0.18 to 0.78, k=8, NNT=3.76) when PPT was compared with waitlist control conditions at post-treatment assessment. When compared with active control conditions, PPT yielded large effect sizes for increasing positive outcomes (g=−0.92, 95% CI: −1.74 to −0.11, k=6, NNT=2.05) and reducing depression (g=0.94, 95% CI: 0.18 to 1.70, k=6, NNT=2.03) at post-treatment assessment. No significant differences in efficacy were found when compared with established treatments such as cognitive–behavioural therapy. Evidence was found to support an association between trial quality and effect sizes. For positive outcomes, higher trial quality was related to larger effect size. Whereas higher trial quality was associated with smaller effect size for depression. Follow-up assessments remained too scarce for most planned analyses.ConclusionsOur findings support the short-term efficacy of PPT. However, results are to be regarded with due caution in the light of low number of trials. More high-quality trials that assess efficacy at follow-ups are needed to draw firmer conclusions on the long-term efficacy of PPT.PROSPERO registration numberCRD42020173567.

The Impact of COVID-19 on College Students’ Physical Activity: A Protocol for Systematic Review and Meta Analysis

Background: We aimed to conduct a meta-analysis to assess the impact of coronavirus disease 2019 (COVID-19) on college students’ physical activity.Methods: All cohort studies, comparing college students undertaking physical exercise at school before the COVID-19 pandemic and physical exercise at home during the COVID-19 pandemic will be included in this review. We will use index words related to college students, physical exercise and COVID-19 to perform literature searches in PubMed, Medline, Embase and CNKI databases, to include articles indexed as of June 20, 2021 in English and Chinese language. Two reviewers will independently select trials for inclusion, assess trial quality and extract information for each included trials. Primary outcomes are exercise frequency, duration and intensity and associated factors. Based on Cochrane assessment tool, we will evaluate the risk of bias of the included studies. Revman 5.3 will be used for heterogeneity assessment, data synthesis, subgroup analysis, sensitivity analysis and generating funnel-plots.Discussion: The stronger evidence about the impact of COVID-19 on college students’ physical activity will be provided, so as to better guide teaching practice.Systematic review registration: PROSPERO CRD42021262390.

Automation in pharmaceutical sector by implementation of artificial intelligence platform: a way forward

Worldwide, there are technological advances that swift automation in several aspects of the pharmaceutical industry such as pharmacovigilance, clinical research, medical affairs, and marketing. Innovative technology like artificial intelligence (AI) emphasizes the massive use of the internet for drug development, drug safety, data analytics, communication marketing, and customer engagement to achieve the goal of pharmaceuticals and patient-centric healthcare. Presently, escalating the number of individual case safety reports (ICSRs) necessitate the support of AI in the transformation of drug safety professional. AI can be transformed and evolve the clinical trial process from the conventional method alongside benefited the cutting cost, enhancing the trial quality, and alleviate trial time by almost half. Today, AI may be efficiently implemented to lower the cost of medical information requests, besides the online chatbots to communicate with health care professionals (HCPs) and consumers. There are numerous forthcoming uses of AI which need to be executed for renovation in the field of pharmaceuticals.