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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 -
The European Respiratory Journal Jun 2017There is currently no consensus on approaches to defining asthma or assessing asthma outcomes using electronic health record-derived data. We explored these approaches... (Review)
Review
There is currently no consensus on approaches to defining asthma or assessing asthma outcomes using electronic health record-derived data. We explored these approaches in the recent literature and examined the clarity of reporting.We systematically searched for asthma-related articles published between January 1, 2014 and December 31, 2015, extracted the algorithms used to identify asthma patients and assess severity, control and exacerbations, and examined how the validity of these outcomes was justified.From 113 eligible articles, we found significant heterogeneity in the algorithms used to define asthma (n=66 different algorithms), severity (n=18), control (n=9) and exacerbations (n=24). For the majority of algorithms (n=106), validity was not justified. In the remaining cases, approaches ranged from using algorithms validated in the same databases to using nonvalidated algorithms that were based on clinical judgement or clinical guidelines. The implementation of these algorithms was suboptimally described overall.Although electronic health record-derived data are now widely used to study asthma, the approaches being used are significantly varied and are often underdescribed, rendering it difficult to assess the validity of studies and compare their findings. Given the substantial growth in this body of literature, it is crucial that scientific consensus is reached on the underlying definitions and algorithms.
Topics: Algorithms; Asthma; Clinical Studies as Topic; Electronic Health Records; Humans; Outcome Assessment, Health Care; Quality Improvement
PubMed: 28619959
DOI: 10.1183/13993003.00204-2017 -
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 -
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 -
International Journal of Gynaecology... Dec 2017An evaluation of outcome reporting is required to develop a core outcome set. (Review)
Review
BACKGROUND
An evaluation of outcome reporting is required to develop a core outcome set.
OBJECTIVES
To assess primary outcomes and outcome measure reporting in pre-eclampsia trials.
SEARCH STRATEGY
Five online databases were searched from inception to January 2016 using terms including "preeclampsia" and "randomized controlled trial".
SELECTION CRITERIA
Randomized controlled trials evaluating treatments for pre-eclampsia published in any language were included.
DATA COLLECTION AND ANALYSIS
Primary outcomes and data on outcome measure reporting were systematically extracted and categorized.
MAIN RESULTS
Overall, 79 randomized trials including data from 31 615 women were included. Of those, 38 (48%) reported 35 different primary outcomes; 28 were maternal outcomes and seven were fetal/neonatal outcomes. Three randomized trials reported composite outcomes, incorporating between six and nine outcome components. The method of definition or measurement was infrequently or poorly reported. Even when outcomes were consistent across trials, different methods of definition or measurement were frequently described.
CONCLUSIONS
In randomized trials evaluating interventions for pre-eclampsia, critical information related to the primary outcome, including definition and measurement, is regularly omitted. Developing a core outcome set for pre-eclampsia trials would help to inform primary outcome selection and outcome measure reporting.
Topics: Female; Humans; Outcome Assessment, Health Care; Pre-Eclampsia; Pregnancy; Randomized Controlled Trials as Topic; Research Design
PubMed: 28803445
DOI: 10.1002/ijgo.12298 -
PharmacoEconomics Dec 2023Missing data in costs and/or health outcomes and in confounding variables can create bias in the inference of health economics and outcomes research studies, which in...
BACKGROUND
Missing data in costs and/or health outcomes and in confounding variables can create bias in the inference of health economics and outcomes research studies, which in turn can lead to inappropriate policies. Most of the literature focuses on handling missing data in randomized controlled trials, which are not necessarily always the data used in health economics and outcomes research.
OBJECTIVES
We aimed to provide an overview on missing data issues and how to address incomplete data and report the findings of a systematic literature review of methods used to deal with missing data in health economics and outcomes research studies that focused on cost, utility, and patient-reported outcomes.
METHODS
A systematic search of papers published in English language until the end of the year 2020 was carried out in PubMed. Studies using statistical methods to handle missing data for analyses of cost, utility, or patient-reported outcome data were included, as were reviews and guidance papers on handling missing data for those outcomes. The data extraction was conducted with a focus on the context of the study, the type of missing data, and the methods used to tackle missing data.
RESULTS
From 1433 identified records, 40 papers were included. Thirteen studies were economic evaluations. Thirty studies used multiple imputation with 17 studies using multiple imputation by chained equation, while 15 studies used a complete-case analysis. Seventeen studies addressed missing cost data and 23 studies dealt with missing outcome data. Eleven studies reported a single method while 20 studies used multiple methods to address missing data.
CONCLUSIONS
Several health economics and outcomes research studies did not offer a justification of their approach of handling missing data and some used only a single method without a sensitivity analysis. This systematic literature review highlights the importance of considering the missingness mechanism and including sensitivity analyses when planning, analyzing, and reporting health economics and outcomes research studies.
Topics: Humans; Data Interpretation, Statistical; Bias; Research Design; Cost-Benefit Analysis; Outcome Assessment, Health Care
PubMed: 37490207
DOI: 10.1007/s40273-023-01297-0 -
Applied Health Economics and Health... Aug 2015Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic... (Review)
Review
BACKGROUND
Generic drugs are considered therapeutically equivalent to their original counterparts and lower in acquisition costs. However, the overall impact of generic substitution (GS) on global clinical and economic outcomes has not been conclusively evaluated.
OBJECTIVE
To test whether (1) generics and original products yield the same health outcomes, and (2) generic therapies save economic resources versus original therapies.
METHODS
We performed a systematic literature review in Medline, Embase, and the Cochrane Database of Systematic Reviews to identify original studies that examine clinical or economic outcomes of GS. After standardized data extraction, reported outcomes were categorized as supporting or rejecting the hypotheses. Each reported outcome was assessed and accounted for supporting and opposing GS. One publication could provide multiple outcome comparisons.
RESULTS
We included 40 studies across ten therapeutic areas. Fourteen studies examined patients on de novo therapy; 24 studies investigated maintenance drug therapy, and two studies considered both settings. Overall, 119 outcome comparisons were examined. Of 97 clinical outcome comparisons, 67% reported no significant difference between generic drugs and their off-patent counterparts. Of 22 economic comparisons, 64% suggested that GS increased costs. Consequently, hypothesis (1) was supported but hypothesis (2) was not. We found no major differences among studies that investigated clinical outcomes with de novo or maintenance therapy.
CONCLUSION
The review suggests that clinical effects are similar after GS. However, economic savings are not guaranteed. More systematic research comparing clinical and economic outcomes with or without GS is needed to inform policy on the use of generic substitution.
Topics: Cost-Benefit Analysis; Databases, Bibliographic; Drug Substitution; Drugs, Generic; Humans; Outcome Assessment, Health Care
PubMed: 26091709
DOI: 10.1007/s40258-014-0147-0 -
Canadian Journal of Surgery. Journal... Apr 2017The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patient-important outcomes than surrogate or laboratory-based outcomes.
METHODS
We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in random-effects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification.
RESULTS
In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patient-important primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63-1.1, 2 = 21%).
CONCLUSION
A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patient-important outcomes are the focus of study.
Topics: Humans; Outcome Assessment, Health Care; Patient Outcome Assessment; Randomized Controlled Trials as Topic; Surgical Procedures, Operative
PubMed: 28234219
DOI: 10.1503/cjs.010616 -
BMC Research Notes Dec 2015A significant relationship exists between the volume of surgical procedures that a given center performs and subsequent outcomes. It seems plausible that such a... (Review)
Review
BACKGROUND
A significant relationship exists between the volume of surgical procedures that a given center performs and subsequent outcomes. It seems plausible that such a volume-outcome relationship is also present in dialysis.
METHODS
MEDLINE and EMBASE were searched in November 2014 for non-experimental studies evaluating the association between center volume and patient outcomes [mortality, morbidity, peritonitis, switch to hemodialysis (HD) or any other treatment], without language restrictions or other limits. Selection of relevant studies, data extraction and critical appraisal were performed by two independent reviewers. We did not perform meta-analysis due to clinical and methodological heterogeneity (e.g. different volume categories).
RESULTS
16 studies met out inclusion criteria. Most studies were performed in the US. The study quality ranged from fair to good. Only few items were judged to have a high risk of bias, while many items were judged to have an unclear risk of bias due to insufficient reporting. All 10 studies that analyzed peritoneal dialysis (PD) technique survival by modeling switch to HD or any other treatment as an outcome showed a statistical significant effect. The relative effect measures ranged from 0.25 to 0.94 (median 0.73) in favor of high volume centers. All nine studies indicated a lower mortality for PD in high volume centers, but only study was statistical significant.
CONCLUSIONS
This systematic review supports a volume-outcome relationship in peritoneal dialysis with respect to switch to HD or any other treatment. An effect on mortality is probably present in HD. Further research is needed to identify and understand the associations of center volume that are causally related to patient benefit.
Topics: Hospitals, High-Volume; Humans; Outcome Assessment, Health Care; Renal Dialysis; Renal Insufficiency
PubMed: 26695620
DOI: 10.1186/s13104-015-1785-5 -
European Urology Sep 2014A standardised system to report outcomes and complications of urologic procedures has recently been proposed by an ad hoc European Association of Urology (EAU)... (Review)
Review
CONTEXT
A standardised system to report outcomes and complications of urologic procedures has recently been proposed by an ad hoc European Association of Urology (EAU) Guidelines panel. To date, no studies have used these criteria to evaluate the quality of reports of outcomes and complications after partial nephrectomy (PN).
OBJECTIVE
To address the quality of reporting of PN complications.
DESIGN, SETTING, AND PARTICIPANTS
A systematic review of papers reporting outcomes of PN was conducted through the electronic search of databases, including Medline, PubMed, Embase, Scopus, and the Cochrane Database of Systematic Reviews.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
Analysis was carried out on structured forms. The quality criteria that the EAU Working Group proposed for reporting complications were recorded for each paper, and adherence to the Martin criteria was assessed.
RESULTS AND LIMITATIONS
Standardised criteria to report and grade complications were used in 71 out of 204 evaluable studies (34.8%). Only six studies (2.9%) fulfilled all criteria that the EAU Guidelines Office ad hoc panel proposed. The mean number did not change significantly by time or by surgical approach used. The most underreported criteria (in <50% of the studies) were who collected the data (18.6%), whether he or she were involved in the treatment (13.7%), duration of follow-up (47.1%), mortality data and causes of death (33.8%), definition of procedure-specific complications (39.2), separate reporting of intra- and postoperative complications (45.1%), complication severity or grade (32.4%), risk factors analysis (44.1%), readmission rates (12.7%), and percentage of patients lost to follow-up (6.9%). The mean number fulfilled was 6.5 ± 2.9 (mean plus or minus standard deviation) and did not change significantly by time or by surgical approach used.
CONCLUSIONS
The only way to improve the quality of the surgical scientific literature and to allow sound comparisons among different approaches, especially with the lack of randomised trials, is the use of more rigorous methodology than the one recently proposed to report outcomes and complications.
PATIENT SUMMARY
A rigorous methodology is mandatory when surgeons report about complications after surgery. Otherwise, the rate of adverse events is underestimated.
Topics: Guidelines as Topic; Humans; Nephrectomy; Outcome Assessment, Health Care; Quality Indicators, Health Care; Research Design
PubMed: 24576502
DOI: 10.1016/j.eururo.2014.02.004