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Tropical Medicine & International... Sep 2022Malaria is one of the most important parasitic infectious diseases worldwide. Despite the scale-up of effective antimalarials, mortality rates from severe malaria (SM)... (Review)
Review
OBJECTIVES
Malaria is one of the most important parasitic infectious diseases worldwide. Despite the scale-up of effective antimalarials, mortality rates from severe malaria (SM) remain significantly high; thus, numerous trials are investigating both antimalarials and adjunctive therapy. This review aimed to summarise all the outcome measures used in trials in the last 10 years to see the need for a core outcome set.
METHODS
A systematic review was undertaken to summarise outcomes of individually randomised trials assessing treatments for SM in adults and children. We searched key databases and trial registries between 1 January 2010 and 30 July 2020. Non-randomised trials were excluded to allow comparison of similar trials. Trial characteristics including phase, region, population, interventions, were summarised. All primary and secondary outcomes were extracted and categorised using a taxonomy table.
RESULTS
Twenty-seven of 282 screened trials met our inclusion criteria, including 10,342 patients from 19 countries: 19 (70%) trials from Africa and 8 (30%) from Asia. A large amount of heterogeneity was observed in the selection of outcomes and instruments, with 101 different outcomes measures recorded, 78/101 reported only in a single trial. Parasitological outcomes (17 studies), neurological status (14 studies), death (14 studies) and temperature (10 studies), were the most reported outcomes. Where an outcome was reported in >1 study it was often measured differently: temperature (4 different measures), renal function (7 measures), nervous system (13 measures) and parasitology (10 measures).
CONCLUSION
Outcomes used in SM trials are inconsistent and heterogeneous. Absence of consensus for outcome measures used impedes research synthesis and comparability of different interventions. This systematic review demonstrates the need to develop a standardised collection of core outcomes for clinical trials of treatments for SM and next steps to include the development of a panel of experts in the field, a Delphi process, and a consensus meeting.
Topics: Adult; Africa; Antimalarials; Child; Consensus; Humans; Malaria; Outcome Assessment, Health Care
PubMed: 35916146
DOI: 10.1111/tmi.13803 -
British Journal of Anaesthesia Jul 2024Heterogeneity of reported outcomes can impact the certainty of evidence for prehabilitation. The objective of this scoping review was to systematically map outcomes and... (Review)
Review
BACKGROUND
Heterogeneity of reported outcomes can impact the certainty of evidence for prehabilitation. The objective of this scoping review was to systematically map outcomes and assessment tools used in trials of surgical prehabilitation.
METHODS
MEDLINE, EMBASE, PsychInfo, Web of Science, CINAHL, and Cochrane were searched in February 2023. Randomised controlled trials of unimodal or multimodal prehabilitation interventions (nutrition, exercise, psychological support) lasting at least 7 days in adults undergoing elective surgery were included. Reported outcomes were classified according to the International Society for Pharmacoeconomics and Outcomes Research framework.
RESULTS
We included 76 trials, mostly focused on abdominal or orthopaedic surgeries. A total of 50 different outcomes were identified, measured using 184 outcome assessment tools. Observer-reported outcomes were collected in 86% of trials (n=65), with hospital length of stay being most common. Performance outcomes were reported in 80% of trials (n=61), most commonly as exercise capacity assessed by cardiopulmonary exercise testing. Clinician-reported outcomes were included in 78% (n=59) of trials and most frequently included postoperative complications with Clavien-Dindo classification. Patient-reported outcomes were reported in 76% (n=58) of trials, with health-related quality of life using the 36- or 12-Item Short Form Survey being most prevalent. Biomarker outcomes were reported in 16% of trials (n=12) most commonly using inflammatory markers assessed with C-reactive protein.
CONCLUSIONS
There is substantial heterogeneity in the reporting of outcomes and assessment tools across surgical prehabilitation trials. Identification of meaningful outcomes, and agreement on appropriate assessment tools, could inform the development of a prehabilitation core outcomes set to harmonise outcome reporting and facilitate meta-analyses.
Topics: Humans; Randomized Controlled Trials as Topic; Preoperative Exercise; Postoperative Complications; Patient Reported Outcome Measures; Preoperative Care; Outcome Assessment, Health Care
PubMed: 38570300
DOI: 10.1016/j.bja.2024.01.046 -
Aesthetic Surgery Journal Mar 2020Reduction mammaplasty remains critical to the treatment of breast hypertrophy. No technique has been shown to be superior; however, comparison between studies is...
BACKGROUND
Reduction mammaplasty remains critical to the treatment of breast hypertrophy. No technique has been shown to be superior; however, comparison between studies is difficult due to variation in outcome reporting.
OBJECTIVES
The authors sought to identify a comprehensive list of outcomes and outcome measures in reduction mammaplasty.
METHODS
A comprehensive computerized search was performed. Included studies were randomized or nonrandomized controlled trials involving at least 100 cases of female breast hypertrophy and patients of all ages who underwent 1 or more defined reduction mammaplasty technique. Outcomes and outcome measures were extracted and tabulated.
RESULTS
A total 106 articles were eligible for inclusion; 57 unique outcomes and 16 outcome measures were identified. Frequency of patient-reported and author-reported outcomes were 44% and 88%, respectively. Postoperative complications were the most frequently reported outcome (82.2%). Quality-of-life outcomes were accounted for in 37.7% of studies. Outcome measures were either condition-specific or generic; frequencies were as low as 1% and as high as 5.6%. Five scales were formally assessed in the breast reduction populations. Clinical measures were defined in 15.1% of studies.
CONCLUSIONS
There is marked heterogeneity in reporting of outcomes and outcome measures in the literature. A standardized outcome set is needed to compare outcomes of various reduction mammaplasty techniques.
Topics: Breast; Female; Humans; Hypertrophy; Mammaplasty; Outcome Assessment, Health Care; Quality of Life
PubMed: 31679031
DOI: 10.1093/asj/sjz308 -
Journal of Geriatric Oncology Jun 2021The number of older patients with breast cancer has increased due to the aging of the general population. The use of a geriatric assessment in this population has been... (Review)
Review
The number of older patients with breast cancer has increased due to the aging of the general population. The use of a geriatric assessment in this population has been advocated in many studies and guidelines as it can be used to identify high risk populations for early mortality and toxicity. Additionally, geriatric parameters could predict relevant outcome measures. This systematic review summarizes all available evidence on predictive factors for various outcomes (disease-related and survival, toxicity, and patient-reported outcomes), with a special focus on geriatric parameters and patient-reported outcomes, in older patients with breast cancer. Studies were identified through systematic review of the literature published up to September 1st 2019 in the PubMed database and EMBASe. A total of 173 studies were included. Most studies investigated disease-related and survival outcomes (n = 123, 71%). Toxicity was investigated in 40 studies (23%) and a mere 15% (n = 26) investigated patient-reported outcomes. Various measures that can be derived from a geriatric assessment were predictive for survival endpoints. Furthermore, geriatric parameters were among the most frequently found predictors for toxicity and patient-reported outcomes. In conclusion, this study shows that geriatric parameters can predict survival, toxicity, and patient-reported outcomes in older patients with breast cancer. These findings can be used in daily clinical practice to identify patients at risk of early mortality, high risk of treatment toxicity or poor functional outcome after treatment. A minority of studies used relevant outcome measures for older patients, showing the need for studies that are tailored to the older population.
Topics: Aged; Aging; Breast Neoplasms; Female; Geriatric Assessment; Humans; Outcome Assessment, Health Care; Patient Reported Outcome Measures
PubMed: 33526315
DOI: 10.1016/j.jgo.2021.01.008 -
Pediatric Research Oct 2022Life course studies are designed to "collect once, use multiple times" for observational and, increasingly, interventional research. Core Outcome Sets (COS) are minimum...
BACKGROUND
Life course studies are designed to "collect once, use multiple times" for observational and, increasingly, interventional research. Core Outcome Sets (COS) are minimum sets developed for clinical trials by multi-stakeholder consensus methodologies. We aimed to synthesize published COS that might guide outcomes selection for early life cohorts with an interventional focus.
METHODS
We searched PubMed, Medline, COMET, and CROWN for COS published before January 2021 relevant to four life stages (pregnancy, newborns, children <8 years, and parents (adults aged 18-50 years)). We synthesized core outcomes into overarching constructs.
RESULTS
From 46 COS we synthesized 414 core outcomes into 118 constructs. "Quality of life", "adverse events", "medication use", "hospitalization", and "mortality" were consistent across all stages. For pregnancy, common constructs included "preterm birth", "delivery mode", "pre-eclampsia", "gestational weight gain", "gestational diabetes", and "hemorrhage"; for newborns, "birthweight", "small for gestational age", "neurological damage", and "morbidity" and "infection/sepsis"; for pediatrics, "pain", "gastrointestinal morbidity", "growth/weight", "breastfeeding", "feeding problems", "hearing", "neurodevelopmental morbidity", and "social development"; and for adults, "disease burden", "mental health", "neurological function/stroke", and "cardiovascular health/morbidity".
CONCLUSION
This COS synthesis generated outcome constructs that are of high value to stakeholders (participants, health providers, services), relevant to life course research, and could position cohorts for trial capabilities.
IMPACT
We synthesized existing Core Outcome Sets as a transparent methodology that could prioritize outcomes for lifecourse cohorts with an interventional focus. "Quality of life", "adverse events", "medication use", "hospitalization", and "mortality" are important outcomes across pregnancy, newborns, childhood, and early-to-mid-adulthood (the age range relevant to parents). Other common outcomes (such as "birthweight", "cognitive function/ability", "psychological health") are also highly relevant to lifecourse research. This synthesis could assist new early life cohorts to pre-select outcomes that are of high value to stakeholders (participants, health providers, services), are relevant to lifecourse research, and could position them for future trials and interventional capability.
Topics: Pregnancy; Adult; Female; Infant, Newborn; Humans; Child; Diabetes, Gestational; Birth Weight; Cohort Studies; Premature Birth; Outcome Assessment, Health Care; Research Design
PubMed: 34921214
DOI: 10.1038/s41390-021-01801-2 -
The Journal of Hand Surgery Aug 2020Comparison between studies assessing outcomes after surgical treatment of cubital tunnel syndrome (CuTS) has proven to be difficult owing to variations in outcome...
PURPOSE
Comparison between studies assessing outcomes after surgical treatment of cubital tunnel syndrome (CuTS) has proven to be difficult owing to variations in outcome reporting. This study aimed to identify outcomes and outcome measures used to evaluate postoperative results for CuTS.
METHODS
We performed computerized database searches of MEDLINE and EMBASE. Studies with 20 or more patients aged 18 and older who were undergoing medial epicondylectomy, endoscopic decompression, open simple decompression, or decompression with subcutaneous, submuscular, or intramuscular transposition for ulnar neuropathy at the elbow were included. Outcomes and outcome measures were extracted and tabulated.
RESULTS
Of the 101 studies included, 45 unique outcomes and 31 postoperative outcome measures were identified. These included 7 condition-specific, clinician-reported instruments; 4 condition-specific, clinician-reported instruments; 8 patient-reported, generic instruments; 11 clinician-generated instruments; and one utility measure. Outcome measures were divided into 6 unique domains. Overall, 60% of studies used condition-specific outcome measures. The frequency of any condition-specific outcome measure ranged from 1% to 37% of included studies.
CONCLUSIONS
There is marked heterogeneity in outcomes and outcome measures used to assess CuTS. A standardized core outcome set is needed to compare results of various techniques of cubital tunnel decompression.
CLINICAL RELEVANCE
This study builds on the existing literature to support the notion that there is marked heterogeneity in outcomes and outcome measures used to assess CuTS. The authors believe that a future standardized set of core outcomes is needed to limit heterogeneity among studies assessing postoperative outcomes in CuTS to compare these interventions more easily and pool results in the form of systematic reviews and meta-analyses.
Topics: Humans; Cubital Tunnel Syndrome; Decompression, Surgical; Lumbar Vertebrae; Outcome Assessment, Health Care; Treatment Outcome; Ulnar Nerve
PubMed: 32591175
DOI: 10.1016/j.jhsa.2020.04.001 -
Pediatric Research Mar 2022The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice...
BACKGROUND
The lack of a consensus definition of neonatal sepsis and a core outcome set (COS) proves a substantial impediment to research that influences policy and practice relevant to key stakeholders, patients and parents.
METHODS
A systematic review of the literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. In the included studies, the described outcomes were extracted in accordance with the provisions of the Core Outcome Measures in Effectiveness Trials (COMET) handbook and registered.
RESULTS
Among 884 abstracts identified, 90 randomised controlled trials (RCTs) were included in this review. Only 30 manuscripts explicitly stated the primary and/or secondary outcomes. A total of 88 distinct outcomes were recorded across all 90 studies included. These were then assigned to seven different domains in line with the taxonomy for classification proposed by the COMET initiative. The most frequently reported outcome was survival with 74% (n = 67) of the studies reporting an outcome within this domain.
CONCLUSIONS
This systematic review constitutes one of the initial phases in the protocol for developing a COS in neonatal sepsis. The paucity of standardised outcome reporting in neonatal sepsis hinders comparison and synthesis of data. The final phase will involve a Delphi Survey to generate a COS in neonatal sepsis by consensus recommendation.
IMPACT
This systematic review identified a wide variation of outcomes reported among published RCTs on the management of neonatal sepsis. The paucity of standardised outcome reporting hinders comparison and synthesis of data and future meta-analyses with conclusive recommendations on the management of neonatal sepsis are unlikely. The final phase will involve a Delphi Survey to determine a COS by consensus recommendation with input from all relevant stakeholders.
Topics: Delphi Technique; Humans; Infant, Newborn; Neonatal Sepsis; Outcome Assessment, Health Care; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 34997225
DOI: 10.1038/s41390-021-01883-y -
Journal of Advanced Nursing Feb 2021To determine the effect of Early Warning Track and Trigger Tools on patient outcomes. (Meta-Analysis)
Meta-Analysis Review
AIM
To determine the effect of Early Warning Track and Trigger Tools on patient outcomes.
DESIGN
A systematic review: synthesis without meta-analysis.
DATA SOURCES
Electronic databases were searched from 1 January 2013-1 August 2018 and 221 papers identified.
REVIEW METHODS
A systematic review and narrative synthesis supported the identification of synthesized findings named and reported according to outcome measure.
RESULTS
Five international papers representing over 74,000 patients were included in the analysis. Seven key findings were identified, the impact of NEWS on: (a) cardiopulmonary arrest; (b) mortality; (c) serious adverse events; (d) length of hospital stay; (e) hospital admissions; (f) observation frequency; and (g) Intensive/High dependency Unit admission. Papers identified statistically significant improvements in mortality, serious adverse events, hospital admissions, observation frequency, and intensive care unit/high dependency unit admission when an Early Warning Track and Trigger protocol is in use. There were conflicting results regarding length of stay and cardiopulmonary arrest data.
CONCLUSION
Early Warning Track and Trigger Tools can aid recognition of deteriorating patients. Further research is required in relation to hospital length of stay and cardiopulmonary arrests.
IMPACT
Early warning track and trigger tools have been implemented nationally and to a lesser degree internationally. There is evidence to suggest improved clinical outcomes following their use. Further research needs to combine the use of the National Early Warning Score with an agreed set of measured outcomes, and then subsequent study data could be combined to provide much stronger levels of evidence.
Topics: Early Warning Score; Heart Arrest; Hospitalization; Humans; Intensive Care Units; Length of Stay; Outcome Assessment, Health Care
PubMed: 33128308
DOI: 10.1111/jan.14619 -
Journal of Child Psychology and... Sep 2023Children and young people (CYP) with comorbid physical and/or mental health conditions often struggle to receive a timely diagnosis, access specialist mental health... (Review)
Review
BACKGROUND
Children and young people (CYP) with comorbid physical and/or mental health conditions often struggle to receive a timely diagnosis, access specialist mental health care, and more likely to report unmet healthcare needs. Integrated healthcare is an increasingly explored model to support timely access, quality of care and better outcomes for CYP with comorbid conditions. Yet, studies evaluating the effectiveness of integrated care for paediatric populations are scarce.
AIM AND METHODS
This systematic review synthesises and evaluates the evidence for effectiveness and cost-effectiveness of integrated care for CYP in secondary and tertiary healthcare settings. Studies were identified through systematic searches of electronic databases: Medline, Embase, PsychINFO, Child Development and Adolescent Studies, ERIC, ASSIA and British Education Index.
FINDINGS
A total of 77 papers describing 67 unique studies met inclusion criteria. The findings suggest that integrated care models, particularly system of care and care coordination, improve access and user experience of care. The results on improving clinical outcomes and acute resource utilisation are mixed, largely due to the heterogeneity of studied interventions and outcome measures used. No definitive conclusion can be drawn on cost-effectiveness since studies focused mainly on costs of service delivery. The majority of studies were rated as weak by the quality appraisal tool used.
CONCLUSIONS
The evidence of on clinical effectiveness of integrated healthcare models for paediatric populations is limited and of moderate quality. Available evidence is tentatively encouraging, particularly in regard to access and user experience of care. Given the lack of specificity by medical groups, however, the precise model of integration should be undertaken on a best-practice basis taking the specific parameters and contexts of the health and care environment into account. Agreed practical definitions of integrated care and associated key terms, and cost-effectiveness evaluations are a priority for future research.
Topics: Adolescent; Humans; Child; Tertiary Healthcare; Outcome Assessment, Health Care; Cost-Benefit Analysis; Cost-Effectiveness Analysis; Delivery of Health Care, Integrated
PubMed: 36941107
DOI: 10.1111/jcpp.13786 -
The International Journal of Social... Aug 2022Syria is the main country of origin for refugees in the world. The prevalence of mental disorders in this population is high, but there is a lack of more comprehensive...
BACKGROUND
Syria is the main country of origin for refugees in the world. The prevalence of mental disorders in this population is high, but there is a lack of more comprehensive data on mental health issues in this population.
AIM
This study aims to review the literature for mental health outcomes in Syrian refugees.
METHODS
We performed a systematic quantitative literature review of original observational studies indexed on the MEDLINE via PubMed, Embase, Web of Science, PsycINFO, LILACS, and SciELO databases with quantitative data reporting mental health outcomes in Syrian refugees. A descriptive analysis was conducted, and the quality of the included studies was assessed using an adaptation from The National Institutes of Health (NIH) quality assessment tool for observational studies. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines were followed.
RESULTS
A total of 64 studies were included. The majority were published between 2019 and 2020, and focused on the prevalence of post-traumatic stress disorder (PTSD), depression, and anxiety, with a wide range of variations. Other outcomes were difficulties in the post-migration period and promotive factors for mental health, such as resilience, positive coping strategies, and psychosocial well-being.
CONCLUSIONS
High prevalence rates of mental disorders were observed, as well as risk factors for their occurrence. Studies showed a very high variability of prevalence rates and heterogeneity in methodologies. There is a need for research focusing on other determinants and specific necessities for mental health, especially in the post-resettlement period.
Topics: Humans; Mental Health; Outcome Assessment, Health Care; Refugees; Stress Disorders, Post-Traumatic; Syria
PubMed: 35657322
DOI: 10.1177/00207640221099404