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Journal of Clinical Nursing Sep 2023Nurses comprise the largest portion of the healthcare workforce worldwide. However, nurse representation in the leadership of clinical research and research funding is... (Review)
Review
BACKGROUND
Nurses comprise the largest portion of the healthcare workforce worldwide. However, nurse representation in the leadership of clinical research and research funding is largely unknown. The Australasian Nursing and Midwifery Clinical Trials Network was established to provide a coordinated network, focussed on building research capacity in nursing and midwifery. To support this work, this scoping review of nurse-led randomised controlled trials was conducted to summarise research activity, as well as highlight future research directions, gaps and resources. Midwife-led trials will be reported elsewhere.
AIM
To quantify number, type and quality of nurse-led randomised controlled trials registered between 2000-2021.
DESIGN
A scoping review of RCTs.
DATA SOURCES
Medline, Emcare and Scopus were searched from 2000 to August 2021. ANZCTR, NHMRC, MRFF and HRC (NZ) registries were searched from inception to July 2021.
REVIEW METHODS
This review was informed by the JBI scoping review framework using the PRISMA-ScR.
RESULTS
Our search yielded 188 nurse-led publications and 279 registered randomised controlled trials. Multiple trials had the same nurse leaders. There were more registrations than publications. Publications were predominantly of high methodological quality; however, there was a reliance on active controls and blinding was low. Trial registrations indicate that universities and hospital/healthcare organisations were the major sources of funding, while publications indicate that Governments and the National Health and Medical Research Council were the main funding bodies.
CONCLUSION
A small number of high-quality, large-scale, nationally funded randomised controlled trials were identified, with a larger number of locally funded small trials. There was a disparity between the number of registered trials and those published. Additional infrastructure, funding and career frameworks are needed to enable nurses to design, conduct and publish clinical trials that inform the health system and improve health outcomes.
RELEVANCE TO CLINICAL PRACTICE
Research initiated and led by nurses has the potential to improve the health and well-being of individuals and communities, and current nurse-led research is of high methodological quality; however, there were very few nurse-led RCTs, conducted by a small pool of nurse researchers. This gap highlights the need for support in the design, conduct and publishing of nurse-led RCTs.
PATIENT OR PUBLIC CONTRIBUTION
This is a scoping review; therefore, patient or public contribution is not applicable.
Topics: Pregnancy; Humans; Female; Nurse's Role; Midwifery; Hospitals; Randomized Controlled Trials as Topic
PubMed: 36737840
DOI: 10.1111/jocn.16632 -
The Cochrane Database of Systematic... Oct 2023Immune checkpoint inhibitors are increasingly important in the treatment algorithm for locally advanced and metastatic bladder cancer. Numerous ongoing studies are... (Review)
Review
BACKGROUND
Immune checkpoint inhibitors are increasingly important in the treatment algorithm for locally advanced and metastatic bladder cancer. Numerous ongoing studies are investigating these agents as first- and second-line therapies, both alone and in combination with chemotherapy or in a maintenance therapy setting.
OBJECTIVES
To assess the effects of immune checkpoint inhibitors compared to chemotherapy as first- and second-line treatment of advanced or metastatic urothelial carcinoma.
SEARCH METHODS
We performed a comprehensive search including the Cochrane Library, MEDLINE, Embase, three other databases, several trial registers, other sources of gray literature, and conference proceedings, with no restrictions on language of publication. We limited the search period to run from 2000 until August 2022.
SELECTION CRITERIA
We included randomized controlled trials (RCTs) using immunotherapy versus chemotherapy and would have considered non-randomized trials in the absence of randomized trial data. Participants had locally advanced inoperable (cT4b or N+, or both) or metastatic (M1) (or both) urothelial carcinoma of the bladder or upper urinary tract. We excluded studies of people in whom immunotherapy was used in combination with chemotherapy or in a surveillance setting.
DATA COLLECTION AND ANALYSIS
Two review authors independently classified studies for inclusion and abstracted data from included studies. We performed statistical analyses using a random-effects model and interpreted them according to the Cochrane Handbook for Systematic Reviews of Interventions. We used GRADE guidance to rate the certainty of evidence on a per-outcome basis.
MAIN RESULTS
We included five RCTs and identified seven single-armed studies. The RCTs included 3572 participants comparing immunotherapy versus chemotherapy for the treatment of locally advanced and metastatic bladder cancer. First-line therapy Immunotherapy probably has little to no effect on the risk of death from any cause when used as first-line therapy compared to chemotherapy (hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.87 to 1.07; I = 0%; 3 studies, 2068 participants; moderate-certainty evidence). This corresponds to 750 deaths per 1000 participants with chemotherapy and 11 fewer (45 fewer to 26 more) deaths per 1000 participants with immunotherapy at 36 months. Immunotherapy probably has little to no effect on health-related quality of life (mean difference (MD) 4.10, 95% CI 3.83 to 4.37; 1 study, 393 participants; moderate-certainty evidence), when assuming a minimal clinically important difference (MCID) of at least 6 points (using the Functional Assessment of Cancer Therapy - Bladder [FACT-BL] tool; scale 0 to 156 with higher scores representing better quality of life). Immunotherapy probably reduces adverse events grade 3 to 5 (RR 0.47, 95% CI 0.29 to 0.75; I = 97%; 3 studies, 2046 participants; moderate-certainty evidence). This corresponds to 908 grade 3 to 5 adverse events per 1000 participants with chemotherapy, with 481 fewer (644 fewer to 227 fewer) grade 3 to 5 adverse events per 1000 participants with immunotherapy. We found no evidence for the outcome time to death from bladder cancer. Immunotherapy probably increases the risk of time to disease progression (HR 1.33, 95% CI 1.17 to 1.50; I = 0%; 2 studies, 1349 participants; moderate-certainty evidence). This corresponds to 660 events per 1000 participants with chemotherapy and 102 more (57 more to 152 more) events per 1000 participants with immunotherapy at 36 months. Immunotherapy may reduce discontinuations due to adverse effects (RR 0.47, 95% CI 0.20 to 1.10; I = 94%; 3 studies, 2046 participants; low-certainty evidence). This corresponds to 338 discontinuations per 1000 participants with chemotherapy and 179 fewer (271 fewer to 34 more) discontinuations per 1000 participants with immunotherapy. Second-line therapy Immunotherapy may reduce the risk of death from any cause when used as second-line therapy (HR 0.72, 95% CI 0.63 to 0.81; I = 0%; 2 studies, 1473 participants; low-certainty evidence). This corresponds to 920 deaths per 1000 participants with chemotherapy (vinflunine, paclitaxel, docetaxel) and 59 fewer (95 fewer to 28 fewer) deaths per 1000 participants with immunotherapy at 36 months. Immunotherapy may have little to no effect on health-related quality of life when compared to chemotherapy (MD 4.82, 95% CI -3.11 to 12.75; I = 85%; 2 studies, 727 participants; low-certainty evidence), assuming an MCID of at least 10 points (using the EORTC QLQ tool; scale 0 to 100 with higher scores representing better quality of life). Immunotherapy may reduce adverse events grade 3 to 5 in participants undergoing second-line therapy (RR 0.89, 95% CI 0.81 to 0.97; I = 9%; 2 studies, 1423 participants; low-certainty evidence). This corresponds to 630 grade 3 to 5 adverse events per 1000 participants with chemotherapy and 76 fewer (126 fewer to 25 fewer) grade 3 to 5 adverse events per 1000 participants with immunotherapy. We found no evidence for the outcome of time to death from bladder cancer. We are very uncertain if immunotherapy reduces the risk of disease progression (HR 0.99, 95% CI 0.84 to 1.16; I = 0%; 2 studies, 1473 participants; very low-certainty evidence). Immunotherapy may reduce discontinuations due to adverse events in participants undergoing second-line therapy (RR 0.35, 95% CI 0.17 to 0.72; I = 69%; 2 studies, 1473 participants; low-certainty evidence). This corresponds to 110 discontinuations per 1000 participants with chemotherapy and 72 fewer (91 fewer to 31 fewer) discontinuations per 1000 participants with immunotherapy.
AUTHORS' CONCLUSIONS
Compared to chemotherapy, immunotherapy for treating advanced or metastatic urothelial carcinoma probably has little to no effect on the risk of death from any cause when used as first-line therapy. Still, it may reduce the risk of death from any cause when used as second-line therapy. Health-related quality of life for participants receiving first- and second-line therapy does not appear to be affected by immunotherapy. Immunotherapy probably reduces or may reduce adverse events grade 3 to 5 when used as first- and second-line therapy, respectively.
Topics: Humans; Carcinoma, Transitional Cell; Disease Progression; Immune Checkpoint Inhibitors; Immunotherapy; Systematic Reviews as Topic; Urinary Bladder Neoplasms
PubMed: 37811690
DOI: 10.1002/14651858.CD013774.pub2 -
Clinical and Experimental Medicine Oct 2023Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are hematologic malignancies that mostly affect the elderly and have poor prognoses. Mutations in... (Meta-Analysis)
Meta-Analysis
Efficacy of epigenetic agents for older patients with acute myeloid leukemia and myelodysplastic syndrome in randomized controlled trials: a systematic review and network meta-analysis.
Myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) are hematologic malignancies that mostly affect the elderly and have poor prognoses. Mutations in epigenetic regulatory genes cause AML/MDS through changes in DNA methylation and histone modifications. Some epigenetic agents are used in patients with AML and MDS. However, most studies have focused on azacitidine (AZA) or decitabine (DEC), and few studies have been conducted on combination therapies or other epigenetic therapies. This network meta-analysis (NMA) aimed to compare the efficacy of epigenetic agents overall in patients with AML and MDS. A systematic review and NMA of all available II-III phase randomized controlled trials (RCTs) comparing epigenetic agents were performed. The Embase and PubMed databases were searched for relevant studies. The Bayesian model was used in the NMA, and the surface under the cumulative ranking curve (SUCRA) was used to rank comparisons. The primary endpoint was overall survival (OS), and the secondary endpoints were complete response (CR) and partial response (PR). OS was extended by AZA + venetoclax (SUCRA 0.94) in patients with AML and MDS. DEC (SUCRA 0.78) relatively improved CR and PR. In this study, AZA-related treatment was relatively effective in improving the OS of patients with AML and MDS, and DEC-related treatment showed a relatively high effect on CR and PR. The protocol for this systematic review was registered with the International Prospective Register of Systematic Reviews (CRD42022303601).
Topics: Aged; Humans; Azacitidine; Epigenesis, Genetic; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Network Meta-Analysis; Randomized Controlled Trials as Topic; Systematic Reviews as Topic; Treatment Outcome
PubMed: 36964818
DOI: 10.1007/s10238-023-01041-0 -
Multiple Sclerosis and Related Disorders Nov 2023Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard... (Review)
Review
INTRODUCTION
Fatigue is one of the most common and debilitating symptoms in people with multiple sclerosis (PwMS). Disease-modifying therapies (DMTs) are currently the gold standard in the treatment of MS and their effectiveness has been assessed through randomized clinical trials (RCTs). However, there is limited evidence on the impact of DMTs on fatigue in (PwMS). We conducted a systematic review to 1) understand whether fatigue is included as an outcome in MS trials of DMTs; 2) determine the effects on fatigue of treating MS with DMTs and 3) assess the quality of MS trials including fatigue as an outcome.
METHODS
Two independent researchers systematically searched MEDLINE, EMBASE and ClinicalTrials.gov from 1993 to January 2023 for RCTs that measured fatigue as an outcome. Adherence to reporting standards was assessed with the Consolidated Standards of Reporting Trials (CONSORT)-Patient-Reported Outcomes (PRO), while the risk of bias (RoB) was assessed with the RoB 2 tool by the Cochrane Handbook for Systematic Reviews of Interventions. The systematic review protocol was registered in PROSPERO (CRD42022383321).
RESULTS
The search strategy identified 130 RCTs of DMTs of which 7 (5%) assessed fatigue as an outcome. Of the 7 trials, only two presented statistically significant results. In addition, the reporting of fatigue among RCTs was suboptimal with a mean adherence to the CONSORT-PRO Statement of 36% across all trials. Of the 7 trials included, four were assessed as 'high' RoB..
CONCLUSIONS
Fatigue has a major impact on PwMS yet there is limited trial-based evidence on the impact of DMTs on fatigue. Assessment of fatigue as an outcome is underrepresented in trials of DMTs and the reporting of PRO trial data is suboptimal. Thus, it is imperative that MS researchers conduct RCTs that include fatigue as an outcome, to support clinicians and people with MS (PwMS) to consider the impact of the different DMTs on fatigue.
Topics: Humans; Fatigue; Multiple Sclerosis; Patient Reported Outcome Measures; Reference Standards; Systematic Reviews as Topic
PubMed: 37839365
DOI: 10.1016/j.msard.2023.105065 -
BMJ Evidence-based Medicine Mar 2024To evaluate the effects of early introduction to allergenic foods compared with late introduction and its impact on food allergy, food sensitisation and autoimmune... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
To evaluate the effects of early introduction to allergenic foods compared with late introduction and its impact on food allergy, food sensitisation and autoimmune disease risk.
DESIGN AND SETTING
The systematic review was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines. Four electronic databases (MEDLINE, CENTRAL, EMBASE and CINAHL) were searched from inception till 24 October 2022 using keywords and MeSH without limitations on publication's language or date. A forward and backwards citation analysis was also conducted. Risk of bias was assessed by three authors independently, in pairs using the Cochrane Risk of Bias Tool 2. Findings were narratively and quantitatively synthesised. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.
PARTICIPANTS
Randomised controlled trials (RCTs) on allergenic food introduction prior to 12 months of age that evaluated its effect on the development of allergic and autoimmune conditions.
INTERVENTION
Early introduction to allergenic foods to infants diet.
MAIN OUTCOME MEASURES
(1) Food allergy and sensitisation with main measures including oral food challenge, specific-IgE, skin prick testing, physician assessment and parental reporting. (2) Allergic and autoimmune conditions such as asthma and eczema.
RESULTS
Of the 9060 identified records, we included 12 RCTs. We found high to moderate certainty evidence suggested that early introduction of allergen-containing foods reduces the risk of multiple food allergies (4 RCTs, 3854 participants, RR 0.49, 95% CI 0.33 to 0.74), egg (8 RCTs, 5193 participants, RR 0.58, 95% CI 0.44 to 0.78), peanut (3 RCTs, 4183 participants, RR 0.31, 95% CI 0.17 to 0.54) and atopic dermatitis or eczema (4 RCTs, 3579 participants, RR 0.88, 95% CI 0.78 to 1.00). Effects on other food allergies including milk, wheat, fish; autoimmune conditions, and food sensitisation are very uncertain and informed by low and very-low certainty evidence. No important subgroup differences were observed related to baseline risk of allergy and age at introduction. Sensitivity analyses limited to low risk of bias RCTs showed similar results.
CONCLUSIONS
This systematic review and meta-analysis shows that early introduction of allergen-containing food from 4 to 12 months of age, was associated with lower risk of multiple food allergy and eczema. Further research on other allergenic foods, and their long-term impact on food allergy and autoimmune risk is essential for enhancing our understanding on development of these conditions and guiding future clinical recommendations.
PROSPERO REGISTRATION NUMBER
CRD42022375679.
Topics: Infant; Animals; Humans; Food Hypersensitivity; Asthma; Allergens; Eczema
PubMed: 38123975
DOI: 10.1136/bmjebm-2023-112445 -
Interventions of choice for the prevention and treatment of suicidal behaviours: An umbrella review.Nursing Open Aug 2023This umbrella review aims to determine which interventions can be considered as effective in the prevention and treatment of suicidal behaviour. (Review)
Review
AIM
This umbrella review aims to determine which interventions can be considered as effective in the prevention and treatment of suicidal behaviour.
DESIGN
Umbrella review.
METHODS
A systematic search was conducted of works indexed in the PubMed, CINAHL, Cochrane Database of Systematic Reviews, Scopus, ISI Web of Knowledge and Joanna Institute Briggs databases. The search covered works published from 2011 to 2020.
RESULTS
The scientific literature shows that, in addition to being the most prevalent interventions in use, dialectical and cognitive behavioural therapies are the most effective in the treatment and management of suicide attempts and suicidal ideation. It is shown that the prevention and treatment of suicidal behaviour requires multidisciplinary and comprehensive management. Among the interventions that stand out the most are the promotion of providing coping tools, work based on thought and behaviour, and behavioural, psychoanalytic and psychodynamic therapies for the management of emotions.
Topics: Humans; Cognitive Behavioral Therapy; Emotions; Suicidal Ideation; Suicide, Attempted; Systematic Reviews as Topic
PubMed: 37218123
DOI: 10.1002/nop2.1820 -
Computer Methods and Programs in... Mar 2024The recent release of ChatGPT, a chat bot research project/product of natural language processing (NLP) by OpenAI, stirs up a sensation among both the general public and... (Review)
Review
The recent release of ChatGPT, a chat bot research project/product of natural language processing (NLP) by OpenAI, stirs up a sensation among both the general public and medical professionals, amassing a phenomenally large user base in a short time. This is a typical example of the 'productization' of cutting-edge technologies, which allows the general public without a technical background to gain firsthand experience in artificial intelligence (AI), similar to the AI hype created by AlphaGo (DeepMind Technologies, UK) and self-driving cars (Google, Tesla, etc.). However, it is crucial, especially for healthcare researchers, to remain prudent amidst the hype. This work provides a systematic review of existing publications on the use of ChatGPT in healthcare, elucidating the 'status quo' of ChatGPT in medical applications, for general readers, healthcare professionals as well as NLP scientists. The large biomedical literature database PubMed is used to retrieve published works on this topic using the keyword 'ChatGPT'. An inclusion criterion and a taxonomy are further proposed to filter the search results and categorize the selected publications, respectively. It is found through the review that the current release of ChatGPT has achieved only moderate or 'passing' performance in a variety of tests, and is unreliable for actual clinical deployment, since it is not intended for clinical applications by design. We conclude that specialized NLP models trained on (bio)medical datasets still represent the right direction to pursue for critical clinical applications.
Topics: Humans; Artificial Intelligence; Databases, Factual; Natural Language Processing; Physicians; PubMed
PubMed: 38262126
DOI: 10.1016/j.cmpb.2024.108013 -
Sports Biomechanics Dec 2023Individual starts for ventral and dorsal swimming events have changed. After the introduction of back plate and wedge, some studies (mainly on ventral starts) have aimed... (Review)
Review
Individual starts for ventral and dorsal swimming events have changed. After the introduction of back plate and wedge, some studies (mainly on ventral starts) have aimed to clarify their benefits and optimal application. This systematic review is aimed at a critical appraise of the literature on the main findings for back plate and wedge usage. We explored the databases of PubMed, Scopus and Web of Science and conducted a manual search on the reference list of papers. We based our search on the quality scale of the National Health Institutes and found 25 studies that met the eligibility criteria and that scored 7.75 ± 1.18 and 8.0 ± 0.71 on fair-quality studies addressing kick and backstroke starts. Kick start has shown faster start time comparing with grab and track starts by reducing block time and increasing horizontal take-off velocity. Backstroke start using the wedge improved performance through a greater centre of mass vertical position at take-off, horizontal and vertical position at entry and underwater velocity. Swimmers have adopted technical variants of kick and backstroke start by changing block set-up and stance, which should be monitored considering anthropometrics and strength abilities.
Topics: Humans; Swimming; Athletic Performance; Biomechanical Phenomena; Anthropometry; Bibliometrics
PubMed: 35019825
DOI: 10.1080/14763141.2021.2016924 -
Journal of Nephrology Sep 2023This umbrella review aimed to review the effects of resistance training on patients with end-stage renal disease and assess the methodological quality of the available... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
This umbrella review aimed to review the effects of resistance training on patients with end-stage renal disease and assess the methodological quality of the available literature.
METHODS
An umbrella review and meta-meta-analysis was performed. A systematic search was conducted until May 2022. Article selection, quality assessment, and risk of bias assessment were performed by two independent reviewers. The meta-meta-analyses were performed with a random-effects model and the summary statistics were presented in the form of a forest plot with a weighted compilation of all standardized mean differences and corresponding 95% confidence interval. Twenty-four reviews were eventually included. The protocol was registered in the international registry PROSPERO (CRD42022321702).
RESULTS
Resistance training showed positive effects on functional capacity (g = 0.614), aerobic capacity (g = 0.587), health-related quality of life (g = 0.429), and peak force (g = 0.621). Fifteen of the included studies (63%) presented low risk of bias, and the remaining studies (37%) showed unclear risk of bias.
CONCLUSION
Resistance training in patients undergoing hemodialysis is an intervention that shows positive results regarding physical and functional outcomes. The quality level of the literature is inconclusive, but the included studies present low risk of bias.
Topics: Humans; Kidney Failure, Chronic; Quality of Life; Resistance Training; Systematic Reviews as Topic
PubMed: 37318646
DOI: 10.1007/s40620-023-01635-7 -
Human Vaccines & Immunotherapeutics Dec 2023The purpose of the research was to pool the intention to receive the COVID-19 vaccine and its health belief model (HBM)-based predictors, which is helpful for... (Meta-Analysis)
Meta-Analysis
The purpose of the research was to pool the intention to receive the COVID-19 vaccine and its health belief model (HBM)-based predictors, which is helpful for decision-makers and program managers around the globe. The relevant database was searched and Joanna Briggs Institute (JBI) appraisal checklist was used to evaluate the studies. I2 test and funnel plot was utilized to check heterogeneity and publication bias, respectively. DerSimonian and Laird random-effects model was used. The overall pooled intention to receive COVID-19 vaccine globally was 67.69%. Higher levels of perceived susceptibility (AOR = 1.85), perceived severity (AOR = 1.45), perceived benefits (AOR = 3.10), and cues to action (AOR = 3.40) positively predicted the intention; whereas high level of perceived barrier negatively predicted it (AOR = 0.53). Health beliefs influenced COVID-19 vaccine intention globally. This implies that individuals need sound health education and publicity about vaccines before vaccination.
Topics: Humans; COVID-19 Vaccines; Intention; COVID-19; Checklist; Health Belief Model; Vaccination
PubMed: 37170620
DOI: 10.1080/21645515.2023.2207442