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Vaccine Aug 2021Human papillomavirus (HPV) infections are mostly sexually transmitted and cause the greatest share of infection-associated cancers. Each year more than half a million... (Review)
Review
Human papillomavirus (HPV) infections are mostly sexually transmitted and cause the greatest share of infection-associated cancers. Each year more than half a million women are diagnosed with cervical cancer and the mortality rate in West Africa is over ten times higher than that of Northern Europe. HPV vaccines are highly effective at preventing various strains of the infection. However, vaccine hesitancy and access issues have led to low HPV vaccine acceptance in certain countries. A search strategy was developed in PubMed and included an extensive list of keywords and related MeSH/subject headings to capture the many dimensions and expressions of vaccine access, confidence, trust and hesitancy related to HPV vaccination in West Africa. Thirty-five articles were included by full text. Most studies were conducted in Nigeria. Three were conducted in Mali, and one each in Côte d'Ivoire, Ghana and Senegal. The main concerns relating to the vaccine were inadequate information, cost and safety concerns. Several studies also mentioned fertility and promiscuity concerns. Despite over half of West African countries introducing an HPV vaccine pilot project, there is a scarcity of literature on HPV vaccine acceptance in the region. It is important to understand how cultural and gender dynamics in different settings can influence peoples' vaccination decisions. This can be done through in-depth local ethnographies, taking the views of all community members and influencers into account, and complemented by in-depth individual interviews and focus groups.
Topics: Female; Ghana; Humans; Papillomavirus Infections; Papillomavirus Vaccines; Pilot Projects; Uterine Cervical Neoplasms
PubMed: 34366143
DOI: 10.1016/j.vaccine.2021.06.074 -
Pediatric Critical Care Medicine : a... Sep 2015Pilot trials are smaller randomized controlled trials conducted to inform the design and assess the feasibility of a large-scale trials. The objectives of this... (Review)
Review
OBJECTIVES
Pilot trials are smaller randomized controlled trials conducted to inform the design and assess the feasibility of a large-scale trials. The objectives of this systematic review were to describe pilot trials in pediatric critical care, their conclusions about the clinical implications of the results, and the need for future research and to determine the frequency of large follow-up trials.
DATA SOURCES
The Evidence in Pediatric Intensive Care database (http://epicc.mcmaster.ca), a comprehensive repository of published pediatric critical care randomized controlled trials and the World Health Organization's Clinical Trials Registry Platform.
STUDY SELECTION
Randomized controlled trials described in the publication as "pilot," "feasibility," "proof-of-concept," "exploratory," "phase 2," "vanguard," or "preliminary."
DATA EXTRACTION
Pairs of reviewers screened studies for eligibility and abstracted data independently.
DATA SYNTHESIS
We found 32 pilot trials (12.2% of all pediatric critical care randomized controlled trials) published before July 2014, varying in size from 6 to 165 children. Pilot trials were significantly smaller than those not described as pilots, but other key characteristics were not significantly different. The authors of 16 publications (48.4%) included explicit and specific conclusions about the design or feasibility of larger trials based on the results of the pilot trial. In 20 publications (64.5%), the authors made conclusions about clinical efficacy based on results of the pilot trial. Four of the 32 pilot trials (12.9%) led to larger trials, two of which have been published.
CONCLUSIONS
Published pilot trials in pediatric critical care often focus on clinical outcomes. They uncommonly report explicit feasibility outcomes, criteria for success, or rationale for the pilot sample size. These pilot trials infrequently lead to larger trials. Understanding and addressing the reasons for this are key to the success of pediatric critical care research.
Topics: Child; Critical Care; Humans; Pediatrics; Pilot Projects; Randomized Controlled Trials as Topic
PubMed: 26121101
DOI: 10.1097/PCC.0000000000000475 -
Clinical and Experimental Dental... Dec 2023The aim of the systematic review was to compare studies on implant-supported two-unit cantilever crowns with two adjacent implant-supported crowns in the anterior...
OBJECTIVES
The aim of the systematic review was to compare studies on implant-supported two-unit cantilever crowns with two adjacent implant-supported crowns in the anterior region. The second aim was to assess in a 10-year prospective comparative pilot study, hard and soft peri-implant tissue changes in patients with a missing central and adjacent lateral upper incisor, treated with either an implant-supported two-unit cantilever crown or two single implant-supported crowns.
MATERIALS AND METHODS
Medline, Embase, and the Cochrane Central Register of Controlled Trials were searched (last search March 1, 2023). Inclusion criteria were studies reporting outcomes of two missing adjacent teeth in the esthetic region and treated with a single implant-supported two-unit cantilever fixed dental prosthesis, or with two solitary implant-supported crowns. Outcome measures assessed included implant survival (primary), changes in marginal bone and gingiva level, restoration survival, subjective and objective esthetic scores, papilla volume, mid-facial marginal mucosa level, probing depth, bleeding on probing, and biological and technical complications with ≥1-year follow-up. In addition, in a 10-year pilot study, the same outcome measures were assessed of five patients with a single implant-supported two-unit cantilever crown and compared with five patients with two adjacent single implant-supported crowns in the esthetic zone.
RESULTS
Nine articles with 11 study groups were found eligible for data extraction. Meta-analyses of implant survival rates were 96.9% (mean follow-up 3.4 ± 1.4 years) for the implant-cantilever treatment and 97.6% (mean follow-up 3.0 ± 1.8 years) for the adjacent implants treatment (p = .79). In the 10-year comparative pilot study, no clinically relevant changes in hard and soft peri-implant tissue levels occurred in both groups. Patient satisfaction was also high in both groups.
CONCLUSION
Single implant-supported two-unit crowns can be a viable alternative to the placement of two adjacent single implant crowns in the esthetic zone.
Topics: Humans; Dental Implants; Treatment Outcome; Pilot Projects; Dental Implants, Single-Tooth; Prospective Studies; Esthetics, Dental
PubMed: 37592440
DOI: 10.1002/cre2.773 -
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 -
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 -
Dermatologic Therapy Nov 2020Androgenetic alopecia (AGA) is the most common disease associated with hair loss in both females and males. Given the high prevalence of AGA and limited therapeutic... (Review)
Review
Androgenetic alopecia (AGA) is the most common disease associated with hair loss in both females and males. Given the high prevalence of AGA and limited therapeutic methods and the high cost of hair transplantation and ease of use or platelet-rich plasma (PRP) therapies, this systematic review study was conducted to evaluate the effect of PRP on AGA of women. In this systematic review study, English-language articles were searched on PubMed, ISI web of knowledge, and Google Scholar by the end of 2019 with a combination of keywords. Finally, six articles were evaluated. The total number of subjects in this systematic review study was 92 people in six studies. All studies were clinical trials. Most of the studied had been conducted as a pilot study. Follow-up period for patients varied from 6 to 12 months. Except for one study, other studies have reported a positive therapeutic effect for PRP. The major limitation of the studies was the pilot nature and small sample size of these studies. According to the limited studies included in this systematic review, PRP treatment had a positive effect on the improvement of AGA, increasing hair density, and improving hair diameter in affected women.
Topics: Alopecia; Female; Hair; Humans; Male; Pilot Projects; Platelet-Rich Plasma; Treatment Outcome
PubMed: 32588941
DOI: 10.1111/dth.13835 -
European Urology Focus Nov 2021A considerable number of studies addressing the management of lower urinary tract symptoms (LUTS) have been published since 2018. (Review)
Review
CONTEXT
A considerable number of studies addressing the management of lower urinary tract symptoms (LUTS) have been published since 2018.
OBJECTIVE
To review the key studies involving pharmacological and neuromodulation treatment of LUTS published from 2018 onward.
EVIDENCE ACQUISITION
We followed the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) statement. We conducted an Embase/PubMed search of English literature with the words "OAB" or "LUTS" matched with several different treatment modalities. The search ranged between January 2018 and January 2020. All retrieved papers were first reviewed by title and abstract, yielding a total of 236 papers. Additional manuscripts, such as those presented at major meetings, were also included. After revision, 46 publications were included.
EVIDENCE SYNTHESIS
Papers on β3-adrenoreceptor agonists were most abundant. The efficacy and safety of mirabegron in monotherapy and combination therapy were further confirmed by large observational studies and randomized control trials, including one carried out in elderly patients. The use of vibegron for overactive bladder (OAB) was effective and safe in pivotal clinical trials. More database analyses confirm the risk of dementia associated with long-term use of anticholinergics. Onabotulinum toxinA (OnabotA) and sacral neuromodulation provided similar improvement for incontinence in OAB patients at a 2-yr follow-up. Retrospective studies show that OnabotA is effective in men with OAB. New subcutaneous or transcutaneous devices for tibial nerve stimulation were investigated. The potential role of gene therapy in LUTS was assessed in a pilot study.
CONCLUSIONS
Important progresses occurred in the pharmacological and neuromodulation treatments of LUTS, which may change clinical practice. Inoculation of gene vectors was investigated for the first time.
PATIENT SUMMARY
The investigation in the therapeutic field of lower urinary tract symptoms is active. The search for the best option for each patient continues. This systematic review summarizes the findings of the most recent and relevant studies in the field.
Topics: Adrenergic beta-3 Receptor Agonists; Aged; Humans; Lower Urinary Tract Symptoms; Male; Pilot Projects; Retrospective Studies; Urinary Bladder, Overactive
PubMed: 32624454
DOI: 10.1016/j.euf.2020.06.015