Dataset Information

Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years.

ABSTRACT:

Background

Pancreatic adenocarcinoma (PDAC) is a lethal cancer with few therapeutic options. Availability of results is a crucial step in interventional research. Our aim was to evaluate results availability for trials in patients with PDAC and explore associated factors.

Materials and methods

We performed a retrospective cohort study and searched the ClinicalTrials.gov registry for trials evaluating PDAC management with a primary completion date between 1 January 2010 and 1 June 2020. Then, we searched for results submitted on ClinicalTrials.gov and/or published. Our primary outcome was the proportion of PDAC trials with available results: submitted on ClinicalTrials.gov (either publicly available or undergoing quality control check) and/or published in a full-text article. The association of predefined trial characteristics with results availability was assessed.

Results

We identified 551 trials of which 386 (70%) had available results. The cumulative percentage of trials with available results was 21% (95% CI, 18-25%) at 12 months after the primary completion date, 44% (95% CI, 30-48%) at 24 months and 57% (95% CI, 53-61%) at 36 months. Applicable clinical trials, required to comply with the 2007 Food and Drug Administration Amendments Act 801 and its final rule on reporting of results on ClinicalTrials.gov, were more likely to have available results over time (HR 2.1 [95% CI 1.72-2.63], P < .001). Industry-funded, small sample size, and terminated trials were less likely to have available results. Other trial characteristics showed no association with results availability.

Conclusion

Our results highlight a waste in interventional research studying PDAC.

SUBMITTER: Pellat A

PROVIDER: S-EPMC9632316 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Publications

Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years.

Pellat Anna A Boutron Isabelle I Ravaud Philippe P

The oncologist 20221101 11

<h4>Background</h4>Pancreatic adenocarcinoma (PDAC) is a lethal cancer with few therapeutic options. Availability of results is a crucial step in interventional research. Our aim was to evaluate results availability for trials in patients with PDAC and explore associated factors.<h4>Materials and methods</h4>We performed a retrospective cohort study and searched the ClinicalTrials.gov registry for trials evaluating PDAC management with a primary completion date between 1 January 2010 and 1 June ...[more]

PMID: 35983949

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Project description:BackgroundVirtual reality (VR) has shown promising levels of effectiveness in nursing education, pain management, and rehabilitation. However, meta-analyses have discussed the effects of VR usage in nursing unilaterally and inconsistently, and the evidence base is diffuse and varied.ObjectiveWe aimed to synthesize the combined evidence from meta-analyses that assessed the effects of nurses using VR technology on nursing education or patient health outcomes.MethodsWe conducted an umbrella review by searching for meta-analyses about VR intervention in clinical nursing practice on Web of Science, Embase, Cochrane, and PubMed, and in reference lists. Eligible studies were published in English between December 1, 2012, and September 20, 2023. Meta-analyses of ≤2 intervention studies and meta-analyses without 95% CI or heterogeneity data were excluded. Characteristic indicators, population information, VR intervention information, and 95% CIs were extracted. A descriptive analysis of research results was conducted to discern relationships between VR interventions and outcomes. I2 and P values were used to evaluate publication bias. AMSTAR (A Measurement Tool to Assess Systematic Reviews) 2 and the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) checklist were used to appraise literature quality.ResultsIn total, 768 records were identified; 74 meta-analyses were included for review. The most reported VR study conditions were neuronursing (25/74, 34%), pediatric nursing (13/74, 18%), surgical and wound care (11/74, 15%), oncological nursing (11/74, 15%), and older adult nursing (10/74, 14%). Further, 30% (22/74) of meta-analyses reported publication bias, and 15% (11/74) and 8% (6/74) were rated as "high" based on AMSTAR 2 and the GRADE checklist, respectively. The main outcome indicators among all included meta-analyses were pain (37/214, 17.3%), anxiety (36/214, 16.8%), cognitive function (17/214, 7.9%), balance (16/214, 7.5%), depression (16/214, 7.5%), motor function (12/214, 5.6%), and participation in life (12/214, 5.6%). VR treatment for cognition, pain, anxiety, and depression was effective (all P values were <.05), while the utility of VR for improving motor function, balance, memory, and attention was controversial. Adverse effects included nausea, vomiting, and dizziness (incidence: range 4.76%-50%). The most common VR platforms were Pico VR glasses, head-mounted displays, the Nintendo Wii, and the Xbox Kinect. VR intervention duration ranged from 2 weeks to 12 months (typically ≥4 wk). VR session length and frequency ranged from 5 to 100 minutes and from 1 to 10 times per week, respectively.ConclusionsVR in nursing has positive effects-relieving patients' pain, anxiety, and depression and improving cognitive function-despite the included studies' limited quality. However, applying VR in nursing to improve patients' motor function, balance, memory, and attention remains controversial. Nursing researchers need to further explore the effects and standard operation protocols of VR in clinical practice, and more high-quality research on VR in nursing is needed.

Dataset Information

Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years.

Background

Materials and methods

Results

Conclusion

Publications

Availability of Results of Trials Studying Pancreatic Adenocarcinoma over the Past 10 Years.

Similar Datasets

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