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Frontiers in Immunology 2023Recently, the use of immunochemotherapy in the treatment of advanced gastric cancer (GC) has been increasing and programmed cell death protein 1 (PD-1) inhibitors... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Recently, the use of immunochemotherapy in the treatment of advanced gastric cancer (GC) has been increasing and programmed cell death protein 1 (PD-1) inhibitors combined with chemotherapy has become the first-line treatment for advanced GC. However, few studies with small sample sizes have examined this treatment regimen to assess its effectiveness and safety in the neoadjuvant treatment phase of resectable local advanced GC.
MATERIALS AND METHODS
Herein, we systematically searched PubMed, Cochrane CENTRAL, and Web of Science for clinical trials on neoadjuvant immunochemotherapy (nICT) in advanced GC. The primary outcomes were effectiveness [evaluated by major pathological response (MPR) and pathological complete response (pCR)] and safety [assessed by grade 3-4 treatment-related adverse events (TRAEs) and postoperative complications]. A meta-analysis of non-comparative binary results was performed to aggregate the primary outcomes. Direct comparative analysis was used to compare pooled results of neoadjuvant chemotherapy (nCT) with nICT. The outcomes emerged as risk ratios (RR).
RESULTS
Five articles with 206 patients were included, and all of them were from the Chinese population. The pooled pCR and MPR rates were 26.5% (95% CI: 21.3%-33.3%) and 49.0% (95% CI: 42.3%-55.9%), while grade 3-4 TRAEs and post-operative complication rates were 20.0% (95% CI: 9.1%-39.8%) and 30.1% (95% CI: 23.1%-37.9%), respectively. Direct comparison showed that with the exception of grade 3-4 TRAEs and postoperative complications, all outcomes including pCR, MPR, and R0 resection rate favoured nICT to nCT.
CONCLUSION
nICT is a promising strategy for use as an advisable neoadjuvant treatment for patients with advanced GC in Chinese population. However, more phase III randomized controlled trials (RCTs) will be required to further consolidate the efficacy and safety of this regimen.
Topics: Humans; East Asian People; Immunotherapy; Neoadjuvant Therapy; Pilot Projects; Postoperative Complications; Stomach Neoplasms
PubMed: 37426646
DOI: 10.3389/fimmu.2023.1193614 -
Nutrients May 2022To assess the relationship between fat mass percentage (FMP) and glucose metabolism in children aged 0−18 years we performed a systematic review of the literature on... (Meta-Analysis)
Meta-Analysis Review
To assess the relationship between fat mass percentage (FMP) and glucose metabolism in children aged 0−18 years we performed a systematic review of the literature on Medline/PubMed, SinoMed, Embase and Cochrane Library using the PRISMA 2020 guidelines up to 12 October 2021 for observational studies that assessed the relationship of FMP and glucose metabolism. Twenty studies with 18,576 individuals were included in the meta-analysis. The results showed that FMP was significantly associated with fasting plasma glucose (FPG) (r = 0.08, 95% confidence interval (CI): 0.04−0.13, p < 0.001), fasting plasma insulin (INS) (r = 0.48, 95% CI: 0.37−0.57, p < 0.001), and homeostasis model assessment (HOMA)- insulin resistance (IR) (r = 0.44, 95% CI: 0.33−0.53, p < 0.001). The subgroup analysis according to country or overweight and obesity indicated that these associations remained significant between FMP and INS or HOMA-IR. Our results demonstrated that there is a positive relationship between FMP and FPG. Moreover, subgroup analysis according to country or overweight and obesity indicated that FMP is significantly associated with INS and HOMA-IR. This is the first known systematic review and meta-analysis to determine the associations of FMP with glucose metabolism in children and adolescents.
Topics: Adolescent; Blood Glucose; Child; Glucose; Humans; Insulin; Insulin Resistance; Obesity; Overweight
PubMed: 35684072
DOI: 10.3390/nu14112272 -
Radiography (London, England : 1995) Feb 2022Radiation induced skin reactions (RISR) are a common adverse effect of radiotherapy that can impact on patient quality of life. The aim of this systematic review was to... (Review)
Review
INTRODUCTION
Radiation induced skin reactions (RISR) are a common adverse effect of radiotherapy that can impact on patient quality of life. The aim of this systematic review was to identify new research evidence on interventions for RISR to guide health practitioners on best practice skin care for people receiving radiotherapy.
METHODS
A narrative systematic review was adopted including published research since 2014. The MESH search terms used in the 2014 College of Radiographers skin care systematic review were supplemented with terms identified through a pearl growing search technique.
RESULTS
Thirty-three studies were identified and reviewed, 13(39.4%) were assessed as having a high risk of bias 6(18.2%) moderate risk of bias, and 13(39.4%) low risk of bias; one pilot study was not assessed. Twenty-one of the studies were randomised controlled trials, 2 feasibility studies, 9 non-randomised trials, and 1 a pilot study.
CONCLUSION
Evidence from well conducted studies identified prophylactic use of steroid cream for patients, at high risk of RISR, as being the most efficacious in reducing acute skin reactions. Further research is needed on photo biomodulation therapy, studied within standard dose fractionation schedules, before it is recommended for use in practice. There is insufficient evidence to support the use of barrier films or any topical emollients currently in practice to reduce RISRs. Despite the number of new studies in this area there is limited good comparative research of RISR that accounts for predictive risk and new radiotherapy techniques.
IMPLICATIONS FOR PRACTICE
Practitioners are encouraged to risk assess patients prior to radiotherapy to guide interventions and record and monitor patient skin toxicity regularly during treatment, comparing toxicity changes with scores recorded at baseline and support patient self-monitoring of skin reactions.
Topics: Humans; Dose Fractionation, Radiation; Pilot Projects; Quality of Life; Randomized Controlled Trials as Topic; Radiodermatitis; Controlled Clinical Trials as Topic
PubMed: 34649789
DOI: 10.1016/j.radi.2021.09.006 -
The Cochrane Database of Systematic... Dec 2021Trial monitoring is an important component of good clinical practice to ensure the safety and rights of study participants, confidentiality of personal information, and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Trial monitoring is an important component of good clinical practice to ensure the safety and rights of study participants, confidentiality of personal information, and quality of data. However, the effectiveness of various existing monitoring approaches is unclear. Information to guide the choice of monitoring methods in clinical intervention studies may help trialists, support units, and monitors to effectively adjust their approaches to current knowledge and evidence.
OBJECTIVES
To evaluate the advantages and disadvantages of different monitoring strategies (including risk-based strategies and others) for clinical intervention studies examined in prospective comparative studies of monitoring interventions.
SEARCH METHODS
We systematically searched CENTRAL, PubMed, and Embase via Ovid for relevant published literature up to March 2021. We searched the online 'Studies within A Trial' (SWAT) repository, grey literature, and trial registries for ongoing or unpublished studies.
SELECTION CRITERIA
We included randomized or non-randomized prospective, empirical evaluation studies of different monitoring strategies in one or more clinical intervention studies. We applied no restrictions for language or date of publication.
DATA COLLECTION AND ANALYSIS
We extracted data on the evaluated monitoring methods, countries involved, study population, study setting, randomization method, and numbers and proportions in each intervention group. Our primary outcome was critical and major monitoring findings in prospective intervention studies. Monitoring findings were classified according to different error domains (e.g. major eligibility violations) and the primary outcome measure was a composite of these domains. Secondary outcomes were individual error domains, participant recruitment and follow-up, and resource use. If we identified more than one study for a comparison and outcome definitions were similar across identified studies, we quantitatively summarized effects in a meta-analysis using a random-effects model. Otherwise, we qualitatively summarized the results of eligible studies stratified by different comparisons of monitoring strategies. We used the GRADE approach to assess the certainty of the evidence for different groups of comparisons.
MAIN RESULTS
We identified eight eligible studies, which we grouped into five comparisons. 1. Risk-based versus extensive on-site monitoring: based on two large studies, we found moderate certainty of evidence for the combined primary outcome of major or critical findings that risk-based monitoring is not inferior to extensive on-site monitoring. Although the risk ratio was close to 'no difference' (1.03 with a 95% confidence interval [CI] of 0.81 to 1.33, below 1.0 in favor of the risk-based strategy), the high imprecision in one study and the small number of eligible studies resulted in a wide CI of the summary estimate. Low certainty of evidence suggested that monitoring strategies with extensive on-site monitoring were associated with considerably higher resource use and costs (up to a factor of 3.4). Data on recruitment or retention of trial participants were not available. 2. Central monitoring with triggered on-site visits versus regular on-site visits: combining the results of two eligible studies yielded low certainty of evidence with a risk ratio of 1.83 (95% CI 0.51 to 6.55) in favor of triggered monitoring intervention. Data on recruitment, retention, and resource use were not available. 3. Central statistical monitoring and local monitoring performed by site staff with annual on-site visits versus central statistical monitoring and local monitoring only: based on one study, there was moderate certainty of evidence that a small number of major and critical findings were missed with the central monitoring approach without on-site visits: 3.8% of participants in the group without on-site visits and 6.4% in the group with on-site visits had a major or critical monitoring finding (odds ratio 1.7, 95% CI 1.1 to 2.7; P = 0.03). The absolute number of monitoring findings was very low, probably because defined major and critical findings were very study specific and central monitoring was present in both intervention groups. Very low certainty of evidence did not suggest a relevant effect on participant retention, and very low certainty evidence indicated an extra cost for on-site visits of USD 2,035,392. There were no data on recruitment. 4. Traditional 100% source data verification (SDV) versus targeted or remote SDV: the two studies assessing targeted and remote SDV reported findings only related to source documents. Compared to the final database obtained using the full SDV monitoring process, only a small proportion of remaining errors on overall data were identified using the targeted SDV process in the MONITORING study (absolute difference 1.47%, 95% CI 1.41% to 1.53%). Targeted SDV was effective in the verification of source documents, but increased the workload on data management. The other included study was a pilot study, which compared traditional on-site SDV versus remote SDV and found little difference in monitoring findings and the ability to locate data values despite marked differences in remote access in two clinical trial networks. There were no data on recruitment or retention. 5. Systematic on-site initiation visit versus on-site initiation visit upon request: very low certainty of evidence suggested no difference in retention and recruitment between the two approaches. There were no data on critical and major findings or on resource use.
AUTHORS' CONCLUSIONS
The evidence base is limited in terms of quantity and quality. Ideally, for each of the five identified comparisons, more prospective, comparative monitoring studies nested in clinical trials and measuring effects on all outcomes specified in this review are necessary to draw more reliable conclusions. However, the results suggesting risk-based, targeted, and mainly central monitoring as an efficient strategy are promising. The development of reliable triggers for on-site visits is ongoing; different triggers might be used in different settings. More evidence on risk indicators that identify sites with problems or the prognostic value of triggers is needed to further optimize central monitoring strategies. In particular, approaches with an initial assessment of trial-specific risks that need to be closely monitored centrally during trial conduct with triggered on-site visits should be evaluated in future research.
Topics: Humans; Pilot Projects; Prospective Studies
PubMed: 34878168
DOI: 10.1002/14651858.MR000051.pub2 -
Pilot and Feasibility Studies 2018Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory... (Review)
Review
BACKGROUND
Evaluations of complex interventions in public health are frequently undermined by problems that can be identified before the effectiveness study stage. Exploratory studies, often termed pilot and feasibility studies, are a key step in assessing the feasibility and value of progressing to an effectiveness study. Such studies can provide vital information to support more robust evaluations, thereby reducing costs and minimising potential harms of the intervention. This systematic review forms the first phase of a wider project to address the need for stand-alone guidance for public health researchers on designing and conducting exploratory studies. The review objectives were to identify and examine existing recommendations concerning when such studies should be undertaken, questions they should answer, suitable methods, criteria for deciding whether to progress to an effectiveness study and appropriate reporting.
METHODS
We searched for published and unpublished guidance reported between January 2000 and November 2016 via bibliographic databases, websites, citation tracking and expert recommendations. Included papers were thematically synthesized.
RESULTS
The search retrieved 4095 unique records. Thirty papers were included, representing 25 unique sources of guidance/recommendations. Eight themes were identified: pre-requisites for conducting an exploratory study, nomenclature, guidance for intervention assessment, guidance surrounding any future evaluation study design, flexible versus fixed design, progression criteria to a future evaluation study, stakeholder involvement and reporting of exploratory studies. Exploratory studies were described as being concerned with the intervention content, the future evaluation design or both. However, the nomenclature and endorsed methods underpinning these aims were inconsistent across papers. There was little guidance on what should precede or follow an exploratory study and decision-making surrounding this.
CONCLUSIONS
Existing recommendations are inconsistent concerning the aims, designs and conduct of exploratory studies, and guidance is lacking on the evidence needed to inform when to proceed to an effectiveness study.
TRIAL REGISTRATION
PROSPERO 2016, CRD42016047843.
PubMed: 29854417
DOI: 10.1186/s40814-018-0290-8 -
Advances in Nutrition (Bethesda, Md.) May 2017The use of mobile and wireless technologies and wearable devices for improving health care processes and outcomes (mHealth) is promising for health promotion among... (Review)
Review
The use of mobile and wireless technologies and wearable devices for improving health care processes and outcomes (mHealth) is promising for health promotion among patients with chronic diseases such as obesity and diabetes. This study comprehensively examined published mHealth intervention studies for obesity and diabetes treatment and management to assess their effectiveness and provide recommendations for future research. We systematically searched PubMed for mHealth-related studies on diabetes and obesity treatment and management published during 2000-2016. Relevant information was extracted and analyzed. Twenty-four studies met inclusion criteria and varied in terms of sample size, ethnicity, gender, and age of the participating patients and length of follow-up. The mHealth interventions were categorized into 3 types: mobile phone text messaging, wearable or portable monitoring devices, and applications running on smartphones. Primary outcomes included weight loss (an average loss ranging from -1.97 kg in 16 wk to -7.1 kg in 5 wk) or maintenance and blood glucose reduction (an average decrease of glycated hemoglobin ranging from -0.4% in 10 mo to -1.9% in 12 mo); main secondary outcomes included behavior changes and patient perceptions such as self-efficacy and acceptability of the intervention programs. More than 50% of studies reported positive effects of interventions based on primary outcomes. The duration or length of intervention ranged from 1 wk to 24 mo. However, most studies included small samples and short intervention periods and did not use rigorous data collection or analytic approaches. Although some studies suggest that mHealth interventions are effective and promising, most are pilot studies or have limitations in their study designs. There is an essential need for future studies that use larger study samples, longer intervention (≥ 6 mo) and follow-up periods (≥ 6 mo), and integrative and personalized innovative mobile technologies to provide comprehensive and sustainable support for patients and health service providers.
Topics: Blood Glucose; Cell Phone; Diabetes Mellitus; Health Promotion; Humans; Mobile Applications; Monitoring, Ambulatory; Obesity; Self-Management; Telemedicine; Text Messaging; Weight Loss
PubMed: 28507010
DOI: 10.3945/an.116.014100 -
BMJ Global Health Jul 2022Many low-income and middle-income country (LMIC) researchers have disadvantages when applying for research grants. Crowdfunding may help LMIC researchers to fund their...
BACKGROUND
Many low-income and middle-income country (LMIC) researchers have disadvantages when applying for research grants. Crowdfunding may help LMIC researchers to fund their research. Crowdfunding organises large groups of people to make small contributions to support a research study. This manuscript synthesises global qualitative evidence and describes a Special Programme for Research and Training in Tropical Diseases (TDR) crowdfunding pilot for LMIC researchers.
METHODS
Our global systematic review and qualitative evidence synthesis searched six databases for qualitative data. We used a thematic synthesis approach and assessed our findings using the GRADE-CERQual approach. Building on the review findings, we organised a crowdfunding pilot to support LMIC researchers and use crowdfunding. The pilot provided an opportunity to assess the feasibility of crowdfunding for infectious diseases of poverty research in resource-constrained settings.
RESULTS
Nine studies were included in the qualitative evidence synthesis. We identified seven findings which we organised into three broad domains: public engagement strategies, correlates of crowdfunding success and risks and mitigation strategies. Our pilot data suggest that crowdfunding is feasible in diverse LMIC settings. Three researchers launched crowdfunding campaigns, met their goals and received substantial monetary (raising a total of US$26 546 across all three campaigns) and non-monetary contributions. Two researchers are still preparing for the campaign launch due to COVID-19-related difficulties.
CONCLUSION
Public engagement provides a foundation for effective crowdfunding for health research. Our evidence synthesis and pilot data provide practical strategies for LMIC researchers to engage the public and use crowdfunding. A practical guide was created to facilitate these activities across multiple settings.
Topics: Fund Raising; Humans; Pilot Projects; Research Support as Topic
PubMed: 35896184
DOI: 10.1136/bmjgh-2022-009110 -
International Journal of Environmental... Mar 2020The aim of this systematic review was to investigate the effectiveness of various disinfection methods available for stethoscopes. In March 2019, we performed a search...
The aim of this systematic review was to investigate the effectiveness of various disinfection methods available for stethoscopes. In March 2019, we performed a search in PubMed and Scopus using the search terms: "reducing stethoscopes contamination" and "disinfection stethoscopes"; the Mesh terms used in PubMed were "Decontamination/methods" or "Disinfection/methods" and "Stethoscopes/microbiology". Selection criteria were: English language; at least one disinfection method tested. A total of 253 publications were screened. After title, abstract, and full-text analysis, 17 papers were included in the systematic review. Ethanol at 90%, Ethanol-Based Hands Sanitizer (EBHS), triclosan, chlorhexidine, isopropyl alcohol, 66% ethyl alcohol, sodium hypochlorite, and benzalkonium chloride have been proven to lower the presence of bacteria on stethoscopes' surfaces. In addition, alcohol wipes show effective results. A wearable device emitting ultraviolet C by Light-Emitting Diode (LED) resulted efficacious against common microorganisms involved in Healthcare Associated Infections. The cover impregnated with silver ions seemed to be associated with significantly higher colony counts. Instead, copper stethoscopes surface reduced bacterial load. The disinfection of stethoscopes appears to be essential. There are many valid methods available; the choice depends on various factors, such as the cost, availability, and practicality.
Topics: Aged; Child; Cohort Studies; Cross-Sectional Studies; Disinfection; Double-Blind Method; Escherichia coli; Humans; Methicillin-Resistant Staphylococcus aureus; Pilot Projects; Prospective Studies; Staphylococcus aureus; Stethoscopes
PubMed: 32182989
DOI: 10.3390/ijerph17061856 -
BMJ Supportive & Palliative Care Jan 2024Family and friend caregivers often feel overwhelmed by and ill-prepared for their responsibilities. Many feel helpless living with uncertainty about the outcome of the...
OBJECTIVES
Family and friend caregivers often feel overwhelmed by and ill-prepared for their responsibilities. Many feel helpless living with uncertainty about the outcome of the patient's illness, which leads to existential distress. Supportive care interventions that address existential distress by promoting meaning and purpose buffer the negative effects of caregiver burden and promote resilience and growth. The purpose of this scoping review is to describe the depth and breadth of available interventions targeting caregiver existential distress.
METHODS
We followed the Joanna Briggs Institute's scoping review methods and applied the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension checklist. SCOPUS, Ovid MEDLINE and PsycINFO databases were searched for interventions that targeted existential distress by promoting meaning-making, spiritual well-being, post-traumatic growth and/or benefit finding for caregivers of seriously ill adult patients.
RESULTS
We screened 1377 titles/abstracts and 42 full-text articles. Thirty-one articles (28 unique studies) met inclusion criteria. Most interventions were designed for caregivers supporting patients with cancer (n=14) or patients receiving palliative care (n=9). Promising interventions included Meaning-Centered Psychotherapy for Cancer Caregivers, Meaning-Based Intervention for Patients and their Partners, Legacy Intervention for Family Enactment, Family Participatory Dignity Therapy and Existential Behavioural Therapy. More than half of the studies (n=20, 64%) were in the feasibility/acceptability/pilot stage of intervention testing.
CONCLUSION
Large randomised controlled trials with more diverse samples of caregivers are needed. Future research should explore the impact of delivering meaning-making interventions to caregivers throughout the illness trajectory. Developing strategies for scaling up and conducting cost analyses will narrow the research and practice gap for meaning-making interventions.
Topics: Humans; Caregivers; Emotions; Neoplasms; Palliative Care; Stress, Psychological
PubMed: 37604657
DOI: 10.1136/spcare-2023-004448 -
Multiple Sclerosis and Related Disorders Jan 2023People with Multiple Sclerosis (PwMS) find it more difficult to engage in physical activity (PA) than healthy controls. Accelerometers can be used to measure sedentary... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
People with Multiple Sclerosis (PwMS) find it more difficult to engage in physical activity (PA) than healthy controls. Accelerometers can be used to measure sedentary time and free-living physical activity, understanding the differences between PwMS and controls can help inform changes such as interventions to promote a more active lifestyle. This in turn will help prevent secondary conditions and reduce symptom progression.
OBJECTIVE
To conduct a systematic review and meta-analysis on accelerometer measured sedentary behavior and physical activity between PwMS and healthy controls.
METHODS
A systematic search of five databases (PubMed, Web of Science, Ovid, Science Direct and CINAHIL) from inception until 22nd November 2019. Inclusion criteria was (1) included a group of participants with a definite diagnosis of multiple sclerosis of any type; (2) have 3 or more days of PA monitoring using accelerometers during free living conditions; (3) include age matched healthy controls; (4) assess adults over the age of 18; (5) reported data had to have been reported in a manner suitable for quantitative pooling including: percent of time spent sedentary, minutes per day of sedentary, light, moderate, vigorous activity (moderate and vigorous totaled together), steps per day or counts per day.
RESULTS
Initial search produced 9021 papers, after applying inclusion criteria 21 eligible papers were included in the study. One paper was a longitudinal study from which only baseline data was included. One paper was a reliability and validity study, with data for PwMS versus controls in the validity section. All other papers are cross sectional, with one being a pilot study and another a random control study. One paper used two devices in unison, only one set of data is included in the statistics. Outcome data was available for 1098 participants, 579 PwMS and 519 healthy controls. Significant differences were seen in all categories tested: (1) sedentary time (min/day), standard mean difference -0.286, P = 0.044, n = 4 studies; (2) relative sedentary time (%/day), standard mean difference -0.646, P = 0.000, n = 5 studies; (3) LPA (min/day), standard mean difference 0.337, P = 0.039, n = 5 studies; (4) relative LPA (%/day), standard mean difference 0.211, P = 0.152, n = studies; (5) MVPA (min/day), standard mean difference 0.801, P = 0.000, n = 8 studies; (6) relative MVPA (%/day), mean difference 0.914, P = 0.000, n = 5 studies; (7) step count, standard mean difference 0.894, P = 0.000, n = 8 studies; (8) activity count, standard mean difference 0.693, P = 0.000, n = 13 studies.
CONCLUSION
PwMS are more sedentary and engage in less LPA, MVPA, steps per day and accelerometer counts per day than healthy controls when measured using accelerometers during free-living conditions.
Topics: Adult; Humans; Middle Aged; Sedentary Behavior; Multiple Sclerosis; Longitudinal Studies; Cross-Sectional Studies; Pilot Projects; Reproducibility of Results; Accelerometry; Exercise
PubMed: 36521386
DOI: 10.1016/j.msard.2022.104462