title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Results | PMC10196888 | |||
Overview | The number of preschools and mother-child dyads participating in the | PMC10196888 | ||
Discussion | PMC10196888 | |||
Principal Findings | MINOR | This trial investigated the effect of the On the basis of GLMM, significant reduction in children’s screen time was observed in the intervention group as compared with the waitlist control group. Our findings are consistent with previous studies [In this study, the baseline screen time reported among children was twice... | PMC10196888 | |
Strengths and Limitations | This is one of the pioneer studies that provided strong evidence of the effectiveness of a digitally delivered screen time reduction intervention for parents of preschool children. Furthermore, the intervention also measured self-efficacy as a principal construct of the SCT, thus affirming its use in screen time studie... | PMC10196888 | ||
Abbreviations | Consolidated Standards of Reporting Trialsgeneralized linear mixed modelintracorrelation coefficientmovement control orderrandomized controlled trialSocial Cognitive Theory | PMC10196888 | ||
Data Availability | The data sets generated and analyzed during this study are available from the corresponding author upon reasonable request. | PMC10196888 | ||
Abstract | PMC10032296 | |||
Background | psychotic symptoms, treatment-resistant depression, psychosis | “Dissociation” comprises distinct phenomena, some of which are associated with esketamine treatment and some may overlap with positive symptoms of psychosis. Relationships between dissociation and psychotic symptoms assessed by clinician report vs conventional rating scales were investigated in a post hoc analysis of ... | PMC10032296 | |
Methods | psychosis | REGRESSION, ADVERSE EVENT, ADVERSE EVENT | Adverse events of dissociation or psychosis were examined via investigator report and the Clinician Administered Dissociative States Scale (CADSS) and Brief Psychiatric Rating Scale-Plus, respectively, 40 minutes post first esketamine dose. The range of CADSS total scores associated with investigator-reported severity ... | PMC10032296 |
Results | Hallucinations, investigator-reported, delusions | ADVERSE EVENTS, EVENTS, ADVERSE EVENT | Dissociation was reported as an adverse event in 14.3% (109/764) of patients. Severity of most CADSS items increased with the severity of investigator-reported dissociation. No CADSS cutoff point discriminated well between the presence and absence of dissociation events. Hallucinations were reported as adverse events i... | PMC10032296 |
Conclusions | psychotic symptoms | ADVERSE EVENTS | CADSS scores and severity of dissociation adverse events move generally in the same direction; however, there is substantial variability in this relationship. No signature profile of dissociative experiences was revealed, and psychotic symptoms were uncommon. | PMC10032296 |
Trial Registration | Clinical Trials.gov identifier: NCT02497287 | PMC10032296 | ||
Significance Statement | TRD, investigator-reported, treatment-resistant depression, delusions, Hallucinations, psychotic symptoms | ADVERSE EVENTS, EVENTS, ADVERSE EVENT | Transient dissociation has been reported with esketamine treatment. Results of a post hoc analysis presented here further characterize the nature and severity of dissociation reported in an open-label phase 3 study (SUSTAIN-2) of esketamine plus a newly initiated oral antidepressant in participants with treatment-resis... | PMC10032296 |
INTRODUCTION | Clinician-Administered, Treatment-emergent adverse, psychosis, psychotic symptoms, psychotic disorders | ADVERSE EVENT | Dissociation is a clinical construct that incorporates a variety of different types of symptoms, ranging from disturbances in perception of sensory, proprioceptive, or temporal information to disturbances in one’s sense of self or identity. The extent to which the nature of these dissociative experiences is consistent ... | PMC10032296 |
MATERIALS AND METHODS | PMC10032296 | |||
Ethical Practices | An independent review board/ethics committees approved the SUSTAIN-2 protocol at each study site, and written informed consent was obtained from all patients before they were enrolled in the study. SUSTAIN-2 is registered at clinicaltrials.gov (identifier: NCT02497287). Study methods pertaining to the work reported her... | PMC10032296 | ||
Patients | MDD, psychotic, DSM-5 | SUSTAIN-2 enrolled adults (≥18 years old) with a diagnosis of recurrent MDD or single episode (≥2 years) MDD without psychotic features per DSM-5 criteria ( | PMC10032296 | |
Study Design | TRD | SUSTAIN-2 was a global, open-label, multicenter, phase 3 study of TRD that evaluated the safety and tolerability of esketamine plus a newly initiated oral antidepressant for up to 1 year ( | PMC10032296 | |
Study Drug | During the induction phase, patients self-administered esketamine nasal spray twice a week for 4 weeks as a flexible-dose regimen, beginning at 28 mg (in those aged ≥65 years) or 56 mg. Subsequent doses could be adjusted (<65 years: 56 or 84 mg; ≥65 years: 28, 56, or 84 mg) based on efficacy and tolerability. All patie... | PMC10032296 | ||
Safety Assessments | dissociative symptoms, auditory and visual disturbances, Dissociative, psychotic symptoms, heaviness | ADVERSE EVENT, ADVERSE EVENT | Adverse events were monitored throughout the study. Dissociative and positive psychotic symptoms, respectively, were assessed pre-dose and 40 and 90 minutes post-dose using the CADSS (Adverse events were also assessed based on investigator report. The SUSTAIN-2 protocol specified that any untoward medical occurrence th... | PMC10032296 |
Statistical Methods | psychiatric | Post hoc analyses were performed on data collected during the first esketamine treatment session. Data were analyzed from the 40-minute measurement taken on the first day of dosing, as this provided the greatest range of CADSS total scores (Confirmatory factor analyses of these data were performed to determine the good... | PMC10032296 | |
STUDY RESULTS | TRD, delusions, depressive disorder, Hallucinations, MDD, Depression | ADVERSE EVENTS, EVENTS, ADVERSE EVENT | A total of 764 patients with TRD were included in the post hoc analyses (Demographics and Clinical CharacteristicsAbbreviations: MADRS, Montgomery and Åsberg Depression Rating Scale; MDD, major depressive disorder; XR, extended release.On day 1, investigators reported an adverse event of dissociation for 14.3% (109/764... | PMC10032296 |
CADSS Cutoff for Determination of Dissociation | Clinician-Administered | EVENTS, ADVERSE EVENT | A CADSS total score >4 was determined to be the most useful in discriminating between those who were classified as experiencing dissociation per adverse event report and those who were not, per the Diagnostic Characteristics of CADSS When Used to Identify Investigator-Reported Dissociation Adverse EventsAbbreviations: ... | PMC10032296 |
CADSS Factor Structure | According to CFA, neither the 3-factor solution reported by Principal axis factoring identified a 1-factor solution, with an eigenvalue of 8.5 and no other factor reaching 1.0. This single factor accounted for 86% of the variance, with 22 of the 23 items of the scale having loadings of at least 0.35. Given the single-f... | PMC10032296 | ||
CADSS Items Associated With Severity of Reported Dissociation Adverse Events | Clinician-Administered | ADVERSE EVENT |
CADSS Item Endorsements by Severity of Dissociation as an Adverse Event as Reported by InvestigatorsAbbreviations: CADSS, Clinician-Administered Dissociative States Scale.
| PMC10032296 |
Association Between Presence of Dissociation and Presence of Psychosis | hallucinations, delusions | ADVERSE EVENTS, ADVERSE EVENT | The aforementioned infrequency of delusions and hallucinations being reported as adverse events limited our ability to quantitatively examine these adverse event reports other than to note that dissociation typically occurred without these phenomena. On the psychometric measures, Spearman rank correlation revealed a we... | PMC10032296 |
DISCUSSION | TRD, treatment-resistant MDD, psychosis, psychotic disorders, behavioral and sensory experiences | ADVERSE EVENT | Dissociation is a pleomorphic clinical construct used to describe a relatively heterogenous set of behavioral and sensory experiences in different clinical contexts. In the treatment of TRD with glutamate receptor modulators, the aspects of dissociation most commonly described as associated with treatment are more limi... | PMC10032296 |
Limitations | psychotic symptoms, TRD, hallucinations, delusions | ADVERSE EVENT | As noted, these data are limited to those collected during the first (to our knowledge) open-label treatment session for patients being treated for TRD using esketamine nasal spray; consequently, doses were limited to 28 mg in patients ≥65 years and 56 mg for all others (In summary, although adverse event reports and C... | PMC10032296 |
Acknowledgments | We acknowledge Sandra Norris, PharmD, of the Norris Communications Group LLC for medical writing assistance and Ellen Baum, PhD (Janssen Global Services, LLC) for additional editorial support. Dr. Ibrahim Turkoz conducted the statistical analyses. All authors were involved in interpretation of the results and writing a... | PMC10032296 | ||
Data Sharing and Accessibility | Johnson & Johnson is | The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at | PMC10032296 | |
Interest Statement | Drs David Williamson, Ibrahim Turkoz, Stephane Borentain, Ewa Wajs, Jaskaran B. Singh, and Wayne C. Drevets were employees of Janssen Scientific Affairs, Janssen Research & Development, LLC, or Janssen Research & Development Belgium at the time this work was conducted and hold company equity. | PMC10032296 | ||
Role of the Sponsor | Employees of the sponsor, as noted in author contributions, were involved in data analysis or interpretation and/or other aspects pertinent to this work. Authors had full access to all of the data, were involved in writing and/or revising the manuscript, and had final responsibility for the decision to submit for publi... | PMC10032296 | ||
Previous Presentations | Elements of this research were presented in poster form at the 15th Annual Scientific Meeting of the International Society for CNS Clinical Trials and Methodology, February 19-21, 2019, Washington, DC. | PMC10032296 | ||
References | PMC10032296 | |||
Background | Lactic Acidosis, diabetic | LACTIC ACIDOSIS | Despite paucity of data, it is common practice to discontinue metformin before invasive coronary angiography due to an alleged risk of Metformin-Associated Lactic Acidosis (M-ALA). We aimed at assessing the safety of metformin continuation in diabetic patients undergoing coronary angiography in terms of significant inc... | PMC9902064 |
Methods | diabetic, associated-acute kidney injury | In this open-label, prospective, multicentre, single-arm trial, all diabetic patients undergoing coronary angiography with or without percutaneous coronary intervention at 3 European centers were screened for enrolment. The primary endpoint was the increase in lactate levels from preprocedural levels at 72-h after the ... | PMC9902064 | |
Results | non-cardiac, diabetic | 142 diabetic patients on metformin therapy were included. Median preprocedural lactate level was 1.8 mmol/l [interquartile range (IQR) 1.3–2.3]. Lactate levels at 72 h after coronary angiography were 1.7 mmol/l (IQR 1.3–2.3), with no significant differences as compared to preprocedural levels (p = 0.91; median differen... | PMC9902064 | |
Graphical Abstract | PMC9902064 | |||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12933-023-01744-4. | PMC9902064 | ||
Keywords | PMC9902064 | |||
Background | DIABETES MELLITUS (DM) | In the past decades, the prevalence of diabetes mellitus (DM) has significantly increased worldwide, and it is estimated that 592 million people will be affected by DM in 2035 [ | PMC9902064 | |
Research design and methods | PMC9902064 | |||
Study design and population | diabetic | This is an open-label, prospective, multicentre, single-arm trial. All diabetic patients undergoing coronary angiography with or without PCI at 3 participating centers (Additional file Coronary angiography and PCI were performed according to standard techniques; stent and technique choice were based on operators’ prefe... | PMC9902064 | |
Endpoint definitions and follow-up | ACUTE KIDNEY INJURY | The primary endpoint was the difference in lactate levels from preprocedural levels at 72 h after coronary angiography. Secondary endpoints included CA-AKI, M-ALA, and all-cause mortality. CA-AKI was defined according to the Acute Kidney Injury Network criteria as an increase by ≥ 50% or ≥ 0.3 mg/dl within 72 h after c... | PMC9902064 | |
Statistical analysis | diabetic | The sample size was calculated to detect with 90% power a prespecified increase of lactate of 20% from preprocedural levels, with a "one-side" probability of alpha error of 0.025. Sample size calculation was based on data from our historical cohort of diabetic patients taking metformin scheduled for coronary angiograph... | PMC9902064 | |
Results | PMC9902064 | |||
Outcomes | PMC9902064 | |||
Postprocedural lactate levels | Median preprocedural lactate level was 1.8 (1.3–2.3) mmol/l, with increased level reported in patients treated with higher dosage of metformin (ρ = 0.18, p = 0.027), while there was no correlation with eGFR (p = 0.984). Lactate levels measured at 72 h after coronary angiography were 1.7 (1.3–2.3) mmol/l, with no signif... | PMC9902064 | ||
Conclusions | DM, diabetic | Metformin is recommended as first line therapy in patients with type 2 DM and is one of the most common drugs assumed by patients scheduled for coronary angiography. The present study expands the limited evidence on the safety of metformin continuation in patients undergoing coronary angiography and PCI. The main findi... | PMC9902064 | |
Glycemic control and adverse events in patients undergoing coronary angiography and PCI | Early guidelines recommendations on the discontinuation of metformin before coronary angiography were based on expert opinion, due to the paucity of evidence in this setting. A common recommendation was to hold metformin on the day of contrast media administration and for the following 48 h, irrespective of the risk of... | PMC9902064 | ||
Risk of CA-AKI and M-ALA with metformin continuation before and after coronary angiography and PCI | diabetic patients [ | HYPERGLYCEMIA | Based on this evidence, the risk–benefit trade-off for metformin continuation or suspension should be weighted considering the risk of hyperglycemia, M-ALA, and CA-AKI. Metformin represents the first-line therapy for diabetic patients [ | PMC9902064 |
Current practice and inconsistency in guidelines | diabetic, chronic kidney disease, PCI.In | COMPLICATION | Current clinical practice guidelines only marginally take into account the evidence provided thus far, probably reflecting the fear of M-ALA and its related mortality and the limitations of the studies evaluating the risk of metformin continuation in patients undergoing coronary angiography and PCI. In addition, guidel... | PMC9902064 |
Prior presentation | MAY | The present study has been presented at EuroPCR 2022, on 17 May 2022. | PMC9902064 | |
Author contributions | MC, JSS, GF and GGS conceived the idea and design for the study. MC and JJS analysed the data. All authors contributed to interpret the data. MC, JSS, and RP drafted the manuscript. All authors contributed to revise the draft critically for important intellectual content and approved the final manuscript. MC, JJS and G... | PMC9902064 | ||
Funding | This work is supported by a research grant from the Italian Ministry of Education to Prof Giulio Stefanini (PRIN 2017N8K7S2). | PMC9902064 | ||
Availability of data and materials | Data are available on reasonable request. | PMC9902064 | ||
Declarations | PMC9902064 | |||
Ethics approval and consent to participate | The study complies with the Declaration of Helsinki and was approved by the Ethics Committee of Humanitas Clinical and Research Hospital. | PMC9902064 | ||
Consent for publication | Not required. | PMC9902064 | ||
Competing interests | Dr. Garcia-Garcia reports the following institutional grant support: Biotronik, Boston Scientific, Medtronic, Abbott, Neovasc, Shockwave, Phillips, and Corflow. Dr. Mehran reports grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb, CSL Behring, DSI, Medtronic, Novartis Phar... | PMC9902064 | ||
Patient and public involvement | Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research. | PMC9902064 | ||
References | PMC9902064 | |||
Objective | Academic Editor: Yuli Huang To evaluate the safety and efficacy of adrenal venous sampling (AVS) via the cubital vein and femoral vein synchronously. | PMC10439828 | ||
Methods | primary aldosteronism | PRIMARY ALDOSTERONISM | A total of 200 patients with primary aldosteronism admitted to the First Hospital of Fujian Medical University were enrolled and randomly divided into a single-path AVS group (SP, | PMC10439828 |
Results | MP | There was no statistical difference between the two groups at baseline. Multipath AVS had a significantly higher success rate of right-sided intubation than single-path AVS (success rate of right-sided intubation/%: SP 87.96 vs MP 95.65, | PMC10439828 | |
Conclusion | PRS | Multipath AVS via the cubital vein and femoral vein improves the success rate of AVS with comparable safety compared to single-path AVS. When the RAV is opened in the III quadrant, the TIG catheter improves the cannulation success rate. The multipath AVS method provides more catheter options. Patients diagnosed with P... | PMC10439828 | |
1. Introduction | fits, confusion, hypokalemia | CLINICAL SYNDROME, HYPERTENSION, PRIMARY ALDOSTERONISM | Primary aldosteronism (PA) is a clinical syndrome characterized by high aldosterone, low renin activity, hypertension, and hypokalemia [The high success rate of AVS has contributed to the development of unilateral adrenalectomy. Many studies have attempted to accomplish AVS through different vascular accesses, catheter... | PMC10439828 |
2. Methods | PMC10439828 | |||
Study Cohort ( | BLOOD | The trial was a national, prospective, single-arm experimental pilot study. Blood screening (aldosterone-to-renin ratio, ARR) was performed at the First Hospital of Fujian Medical University from December 2019 to December 2021, followed by a confirmatory test (dynamic tests to suppress aldosterone production by salt lo... | PMC10439828 | |
2.2. Inclusion Criteria | Hypertension | HYPERTENSION, ENDOCRINE HYPERTENSION | Patients with PA were established based on the standards and followed by the flowchart developed by the 2020 Working Group on Endocrine Hypertension of the European Society of Hypertension ( | PMC10439828 |
2.3. Exclusion Criteria | abnormal coagulation, allergy, hyperthyroidism, iodine allergy, End-stage of the malignant tumor, systemic infection, acute stroke | ACUTE MYOCARDIAL INFARCTION, ABNORMAL COAGULATION, ALLERGY, HYPERTHYROIDISM, IODINE ALLERGY, SYSTEMIC INFECTION, ACUTE STROKE | Patients who were with following conditions were excluded. (1) Patients with severe iodine allergy were at risk for contrast agent allergy. (2) Patients with abnormal coagulation must be corrected first. (3) Patients with acute stroke, acute myocardial infarction, and major surgical history within 1 month were excluded... | PMC10439828 |
2.4. Patients Demographic Characteristics | thrombosis, death, fever, hematoma, ±2 | THROMBOSIS, INTRAOPERATIVE COMPLICATIONS, POSTOPERATIVE COMPLICATIONS, MINOR, VASCULAR RUPTURE, HEMATOMA | (1) Age, sex, height, weight, serum cholesterol, triglycerides, low-density lipoprotein cholesterol, creatinine, glomerular filtration rate, uric acid, and glycated hemoglobin were assessed at baseline. (2) Collected indicators reflecting PA characteristics, including systolic blood pressure (SBP), diastolic blood pres... | PMC10439828 |
2.5. AVS Procedure | adrenal venous blood sample | Single-path AVS was performed by a skilled operator. (1) After disinfection and anesthesia, the middle right cubital vein was punctured and a 5F sheath was inserted. (2) An X-ray was performed on the patient anterior chest and an F-type MPA catheter (Cordis, USA) was inserted into the inferior vena cava to collect a 2 ... | PMC10439828 | |
2.6. AVS Parameter | Selectivity index (SI) was used to assess the adequacy of the adrenal vein cannulations and was calculated as Cortisol | PMC10439828 | ||
2.7. Statistical Analysis | SD | All data were collected, statistically analyzed, and tabulated using the SPSS 22 software (SPSS Inc., Chicago, IL, USA). Continuous variables were expressed as mean ± SD, such as age, height, weight, SBP, DBP, cholesterol, triglycerides, low-density lipoprotein cholesterol, serum creatinine, uric acid, and glycated hem... | PMC10439828 | |
3. Results | PMC10439828 | |||
3.1. Demographic Data ( | The SP-AVS group included 108 patients, 48 of whom were male, with a mean age of (51.07 ± 12.76) years. Baseline SBP was (157.15 ± 21.83) mmHg and baseline DBP was (92.16 ± 13.77) mmHg. In addition, 92 patients were included in the MP-AVS group with an age of (50.89 ± 12.77) years. Forty-five of them were male. Baselin... | PMC10439828 | ||
3.2. AVS Parameters and Complications Analysis | Compared with the SP-AVS, the success rate of right-side intubation in the MP-AVS was higher (success rate of right-side intubation/%: SP-AVS 87.96% vs MP-AVS 95.65%, | PMC10439828 | ||
3.3. Catheter Selection Analysis | In group I, MPA catheters were used in 163 cases (98.19%) and TIG catheters were used in 3 cases (1.81%). In group III, MPA catheters were used in 3 cases (17.65%) and TIG catheters were used in 14 cases (82.35%). As shown in | PMC10439828 | ||
4. Discussion | adrenal venous blood, hemodilution | PRIMARY ALDOSTERONISM, BENDING, POSTOPERATIVE COMPLICATIONS | In this study, we perceptively explored the safety and efficacy of single-path AVS and multipath AVS via the femoral vein and cubital vein for primary aldosteronism. The findings were as follows: (1) Multipath AVS via the cubital vein and femoral vein significantly improved the success rate of AVS and had comparable sa... | PMC10439828 |
5. Conclusion | PRIMARY ALDOSTERONISM | This is the first study on the operational innovation of AVS that demonstrates the effectiveness and safety of simultaneous AVS treatment through the cubital vein and femoral vein, expanding the choice of catheters. The TIG catheter via the femoral vein is an option when the RAV is open towards the third quadrant.Singl... | PMC10439828 | |
Acknowledgments | Hypertensive, renal artery denervation, hypertensive | MYOCARDIAL FIBROSIS | The authors would like to acknowledge the other investigators, the staff, and the participants of the study for their valuable contributions. This study was supported by the grants as follows. (1) Startup Fund for scientific research, the Fujian Medical University: Effect of Xiongdan on myocardial fibrosis in spontaneo... | PMC10439828 |
Data Availability | The raw data supporting the conclusions of this article will be made available by the authors without undue reservation. | PMC10439828 | ||
Disclosure | Han Cai and Zhoufei Fang are co-first authors. | PMC10439828 | ||
Conflicts of Interest | The authors declare that there are no conflicts of interest. | PMC10439828 | ||
Authors' Contributions | primary aldosteronism, fever, hematoma, hypertension, inferior vena cava, hemodilution | PRIMARY ALDOSTERONISM, ALD, HEMATOMA, HYPERTENSION, COMPLICATIONS | Liangdi Xie MD, PhD, and Feng Peng MD, PhD, contributed to conception and design. Zhoufei Fang MD design the study, data reduction, follow-up, statistical analysis, and article writing. Zhoufei Fang is the major AVS operator. Han Cai MD contributed to data reduction and follow-up. Han Cai is also the major AVS operator... | PMC10439828 |
Background | The provision of neonatal care is variable and commonly lacks adequate evidence base; strategic development of methodologically robust clinical trials is needed to improve outcomes and maximise research resources. Historically, neonatal research topics have been selected by researchers; prioritisation processes involvi... | PMC10646876 | ||
Objective | To involve stakeholders including parents, healthcare professionals and researchers to identify and prioritise research questions suitable for answering in neonatal interventional trials in the UK. | PMC10646876 | ||
Design | Research questions were submitted by stakeholders in population, intervention, comparison, outcome format through an online platform. Questions were reviewed by a representative steering group; duplicates and previously answered questions were removed. Eligible questions were entered into a three-round online Delphi su... | PMC10646876 | ||
Participants | One hundred and eight respondents submitted research questions for consideration; 144 participants completed round one of the Delphi survey, 106 completed all three rounds. | PMC10646876 | ||
Results | breast milk fortification, hypothermia | MILD HYPOXIC ISCHAEMIC ENCEPHALOPATHY, NECROTISING ENTEROCOLITIS | Two hundred and sixty-five research questions were submitted and after steering group review, 186 entered into the Delphi survey. The top five ranked research questions related to breast milk fortification, intact cord resuscitation, timing of surgical intervention in necrotising enterocolitis, therapeutic hypothermia ... | PMC10646876 |
Conclusions | We have identified and prioritised research questions suitable for practice-changing interventional trials in neonatal medicine in the UK at the present time. Trials targeting these uncertainties have potential to reduce research waste and improve neonatal care. | PMC10646876 | ||
WHAT IS ALREADY KNOWN ON THIS TOPIC | There is wide variability in neonatal care across the UK.Robust, high-quality interventional trials are the optimal approach to improving the evidence base and reducing variability in neonatal care.It is important to involve parents and other stakeholders in identifying important future research topics but this can be ... | PMC10646876 | ||
WHAT THIS STUDY ADDS | Previous prioritisation processes have identified broad themes of interest; this study identifies specific research questions suitable for answering in interventional trials. | PMC10646876 | ||
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY | This prioritised list of specific research questions can be used by research organisations to support and develop practice-changing interventional trials within neonatology. | PMC10646876 | ||
Introduction | Neonatal clinical care varies widely,Priority setting partnerships have been used throughout perinatal medicine and demonstrate the value of involving key stakeholders such as parents, patients and healthcare professionals alongside researchers.To reduce research waste, clinical uncertainties should be evaluated wherev... | PMC10646876 | ||
Methods | A steering group guided the development and conduct of this work, including representatives from academia, key neonatal organisations, clinical neonatology, neonatal nursing, allied healthcare professionals (AHPs), statisticians and parents with experience of neonatal care (
| PMC10646876 | ||
Scope | The scope of the prioritisation process was developed and agreed by the steering group. Research questions had to be relevant to high-income neonatal care settings and proposed interventions expected to be delivered by neonatal teams. This included care provided on delivery suites, neonatal units, transitional care uni... | PMC10646876 | ||
Overview | Established research priority setting methodology as outlined by the James Lind Alliance was modified by the steering group to focus on detailed PICO questions, rather than general research themes or outcomes.Phase 1: identification of neonatal research questions suitable for addressing in RCTs.Phase 2: review of submi... | PMC10646876 |
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