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Surgery May 2014Recent events in health care reform have brought national attention to integrating patient experiences and expectations into quality metrics. Few studies have... (Comparative Study)
Comparative Study Review
BACKGROUND
Recent events in health care reform have brought national attention to integrating patient experiences and expectations into quality metrics. Few studies have comprehensively evaluated the effect of patient expectations on patient-reported outcomes (PROs) after surgery. The purpose of this study is to systematically review the available literature describing the relationship between patient expectations and postoperative PROs.
METHODS
We performed a search of the literature published before November 1, 2012. Articles were included in the review if (1) primary data were presented, (2) patient expectations regarding a surgical procedure were measured, (3) PROs were measured, and (4) the relationship between patient expectations and PROs was specifically examined. PROs were categorized into 5 subgroups: Satisfaction, quality of life (QOL), disability, mood disorder, and pain. We examined each study to determine the relationship between patient expectations and PROs as well as study quality.
RESULTS
From the initial literature search yielding 1,708 studies, 60 articles were included. Fulfillment of expectations was associated with improved PROs among 24 studies. Positive expectations were correlated with improved PROs for 28 studies (47%), and poorer PROs for 9 studies (15%). Eighteen studies reported that fulfillment of expectations was correlated with improved patient satisfaction, and 10 studies identified that positive expectations were correlated with improved postoperative. Finally, patients with positive preoperative expectations reported less pain (8 studies) and disability (15 studies) compared with patients with negative preoperative expectations.
CONCLUSION
Patient expectations are inconsistently correlated with PROs after surgery, and there is no accepted method to capture perioperative expectations. Future efforts to rigorously measure expectations and explore their influence on postoperative outcomes can inform clinicians and policymakers seeking to integrate PROs into measures of surgical quality.
Topics: Humans; Mood Disorders; Outcome Assessment, Health Care; Pain, Postoperative; Patient Outcome Assessment; Patient Satisfaction; Prevalence; Quality of Life; Self Report; Surgical Procedures, Operative; Surveys and Questionnaires; Treatment Outcome
PubMed: 24787107
DOI: 10.1016/j.surg.2013.12.015 -
International Journal of Nursing Studies Jul 2009To evaluate the empirical evidence linking nursing resources to patient outcomes in intensive care settings as a framework for future research in this area. (Review)
Review
OBJECTIVES
To evaluate the empirical evidence linking nursing resources to patient outcomes in intensive care settings as a framework for future research in this area.
BACKGROUND
Concerns about patient safety and the quality of care are driving research on the clinical and cost-effectiveness of health care interventions, including the deployment of human resources. This is particularly important in intensive care where a large proportion of the health care budget is consumed and where nursing staff is the main item of expenditure. Recommendations about staffing levels have been made but may not be evidence based and may not always be achieved in practice.
METHODS
We searched systematically for studies of the impact of nursing resources (e.g. nurse-patient ratios, nurses' level of education, training and experience) on patient outcomes, including mortality and adverse events, in adult intensive care. Abstracts of articles were reviewed and retrieved if they investigated the relationship between nursing resources and patient outcomes. Characteristics of the studies were tabulated and the quality of the studies assessed.
RESULTS
Of the 15 studies included in this review, two reported a statistical relationship between nursing resources and both mortality and adverse events, one reported an association to mortality only, seven studies reported that they could not reject the null hypothesis of no relationship to mortality and 10 studies (out of 10 that tested the hypothesis) reported a relationship to adverse events. The main explanatory mechanisms were the lack of time for nurses to perform preventative measures, or for patient surveillance. The nurses' role in pain control was noted by one author. Studies were mainly observational and retrospective and varied in scope from 1 to 52 units. Recommendations for future research include developing the mechanisms linking nursing resources to patient outcomes, and designing large multi-centre prospective studies that link patient's exposure to nursing care on a shift-by-shift basis over time.
Topics: Critical Care; Nursing; Outcome Assessment, Health Care
PubMed: 17964577
DOI: 10.1016/j.ijnurstu.2007.07.011 -
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 -
The Journal of Surgical Research Sep 2018Small bowel obstruction (SBO) is a condition which is commonly treated by general surgeons. The evidence base for treatment of this condition is limited in part by...
BACKGROUND
Small bowel obstruction (SBO) is a condition which is commonly treated by general surgeons. The evidence base for treatment of this condition is limited in part by variable reporting of outcomes in the literature. The aim of this study was to identify commonly used outcomes in research on SBO.
METHODS
This review was reported in line with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered with PROSPERO (CRD42017065538). Searches were performed of MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases to identify prospective cohort or randomized trials reporting outcomes of interventions in SBO. Studies addressing diagnostics, pediatric populations, and SBO due to malignancy were excluded. Studies were screened for inclusion. Study and outcome characteristics were extracted into a -predesigned pro forma and mapped onto the Outcome Measures in Rheumatology (OMERACT) framework.
RESULTS
A total of 1222 studies were screened for eligibility, 74 full text articles retrieved, and 51 studies included for synthesis. A total of 50 different outcomes were used. Duration of hospital stay was the most frequently reported outcome (n = 21 studies). Resolution of SBO was reported in 12 studies but only defined in eight studies which used six different definitions. Patient-reported outcomes were reported in only four studies.
CONCLUSIONS
There is a high degree of variation in the outcomes reported in SBO research. There is a clear need for a core outcome set. Development of a patient-reported outcome measure for this condition should also be explored.
Topics: Digestive System Surgical Procedures; Humans; Intestinal Obstruction; Intestine, Small; Length of Stay; Outcome Assessment, Health Care; Postoperative Complications; Time Factors; Treatment Outcome
PubMed: 29937015
DOI: 10.1016/j.jss.2018.03.044 -
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 -
Journal of Comparative Effectiveness... Jan 2018With the aggregation of real-world data in healthcare, opportunities for outcomes research are growing. In this study, we summarize published literature examining...
AIM
With the aggregation of real-world data in healthcare, opportunities for outcomes research are growing. In this study, we summarize published literature examining comparative effectiveness research (CER), treatment patterns, quality of life (QoL) and costs in HER2-negative and triple-negative (TN) metastatic breast cancer (mBC).
METHODS
PubMed (2010-January 2016) and four conferences (2013-January 2016) were searched using MeSH/keywords, including mBC, QoL, morbidity and therapeutics. Studies relating to CER, treatment patterns, QoL, costs or treatment appropriateness in US patients with HER2-negative/TN mBC were included in the review.
RESULTS
Of 1782 identified records, 33 studies met full inclusion criteria: seven related to CER, 18 to treatment patterns, one to treatment appropriateness/navigation, two to QoL and five to costs. Studies varied in objectives, designs and outcomes. Study designs included retrospective chart reviews (52%), retrospective secondary database analyses (27%), economic models (12%), physician surveys (6%) and patient surveys (3%). 25 studies reported results on HER2-negative mBC, six on TN mBC and two on both subtypes. The most common end points examined were treatment patterns, overall survival and progression-free survival.
CONCLUSION
Outcomes research in HER2-negative mBC in the USA was limited, specifically among TN patients, indicating an opportunity for further research in this high unmet need population. Endpoints and treatment options varied, thus, it is difficult to draw summary conclusions about these studies. Outcomes research examining real-world data in mBC has increased in recent years, and may continue to grow with the implementation of new policy programs.
Topics: Breast Neoplasms; Comparative Effectiveness Research; Humans; Outcome Assessment, Health Care; Quality of Life; Receptor, ErbB-2; Triple Negative Breast Neoplasms
PubMed: 29303361
DOI: 10.2217/cer-2017-0027 -
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 -
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 -
BMC Geriatrics Apr 2022Comprehensive geriatric assessment (CGA) addresses the bio-psycho-social needs of older adults through multidimensional assessments and management. Synthesising evidence...
Health outcomes and implementation barriers and facilitators of comprehensive geriatric assessment in community settings: a systematic integrative review [PROSPERO registration no.: CRD42021229953].
BACKGROUND
Comprehensive geriatric assessment (CGA) addresses the bio-psycho-social needs of older adults through multidimensional assessments and management. Synthesising evidence on quantitative health outcomes and implementation barriers and facilitators would inform practice and policy on CGA for community-dwelling older adults.
METHODS
We systematically searched four medical and social sciences electronic databases for quantitative, qualitative, and mixed methods studies published from 1 January 2000 to 31 October 2020. Due to heterogeneity of articles, we narratively reviewed the synthesis of evidence on health outcomes and implementation barriers and facilitators.
RESULTS
We screened 14,151 titles and abstracts and 203 full text articles, and included 43 selected articles. Study designs included controlled intervention studies (n = 31), pre-post studies without controls (n = 4), case-control (n = 1), qualitative methods (n = 3), and mixed methods (n = 4). A majority of articles studied populations aged ≥75 years (n = 18, 42%). CGAs were most frequently conducted in the home (n = 25, 58%) and primary care settings (n = 8, 19%). CGAs were conducted by nurses in most studies (n = 22, 51%). There was evidence of improved functional status (5 of 19 RCTs, 2 of 3 pre-post), frailty and fall outcomes (3 of 6 RCTs, 1 of 1 pre-post), mental health outcomes (3 of 6 RCTs, 2 of 2 pre-post), self-rated health (1 of 6 RCTs, 1 of 1 pre-post), and quality of life (4 of 17 RCTs, 3 of 3 pre-post). Barriers to implementation of CGAs involved a lack of partnership alignment and feedback, poor acceptance of preventive work, and challenges faced by providers in operationalising and optimising CGAs. The perceived benefits of CGA that served to facilitate its implementation included the use of highly skilled staff to provide holistic assessments and patient education, and the resultant improvements in care coordination and convenience to the patients, particularly where home-based assessments and management were performed.
CONCLUSION
There is mixed evidence on the quantitative health outcomes of CGA on community-dwelling older adults. While there is perceived positive value from CGA when carried out by highly skilled staff, barriers such as bringing providers into a partnership, greater acceptance of preventive care, and operational issues could impede its implementation.
Topics: Accidental Falls; Aged; Geriatric Assessment; Humans; Independent Living; Outcome Assessment, Health Care; Quality of Life
PubMed: 35488198
DOI: 10.1186/s12877-022-03024-4 -
Nursing & Health Sciences Dec 2023The aim of this systematic review was to examine the association of nursing workload on patient outcomes in intensive care units. The primary outcome measure was patient... (Review)
Review
The aim of this systematic review was to examine the association of nursing workload on patient outcomes in intensive care units. The primary outcome measure was patient mortality, with adverse events (AE), the secondary outcome measures. Electronic search of databases including MEDLINE, CINAHL, Cochrane, EMCARE, Scopus, and Web of Science were performed. Studies were excluded if they were in non-ICU settings, pediatric, neonatal populations, or if the abstract/full text was unavailable. Risk of bias was assessed by the ROBINS-I tool. After screening 4129 articles, 32 studies were identified as meeting inclusion criteria. The majority of included studies were assessed as having a moderate risk of bias. The nursing activities score (NAS) was the most frequently used tool to assess nursing workload. Our systematic review identified that higher nursing workload was associated with patient-focused outcomes, including increased mortality and AE in the intensive care setting. The varied approaches of measuring and reporting nursing workload make it difficult to translate the findings of the impact of nursing workload on patient outcomes in intensive care settings.
Topics: Infant, Newborn; Humans; Child; Workload; Critical Care; Nursing Care; Intensive Care Units; Outcome Assessment, Health Care
PubMed: 37784243
DOI: 10.1111/nhs.13052