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Epilepsia Nov 2016Quality and safety in epilepsy monitoring units (EMUs) are of great importance because patients' seizures are induced rather than prevented in this hospital setting.... (Review)
Review
OBJECTIVE
Quality and safety in epilepsy monitoring units (EMUs) are of great importance because patients' seizures are induced rather than prevented in this hospital setting. However, the measurement and evaluation of quality and safety in EMUs are heterogeneous, as are practices and processes of care. To improve the measurement of quality and safety in EMUs, we sought to develop evidence-based and consensus-driven quality indicators, adhering to previously described methodologic standards.
METHODS
Candidate quality indicators were identified using a recent systematic review on quality and safety indicators in EMUs. These were supplemented by expert opinion to identify other indicators that had not been reported previously. The candidate quality indicators were then evaluated using a modified Delphi technique among a multidisciplinary EMU quality improvement team. Candidate indicators identified as important and feasible through the Delphi technique were then developed into quality metrics.
RESULTS
Thirty-four candidate indicators were abstracted from 135 studies included in the earlier systematic review, and two additional candidate indicators were suggested through consensus from experts. Consensus was reached after two modified Delphi rounds for 25 quality indicators identified as important. These 25 indicators were then developed into quality metrics using a standardized data collection form and were deployed in an online database for systematic data capture and further analyses.
SIGNIFICANCE
These quality indicators have the potential to improve the reporting of quality and safety in EMUs through standardized measurement and evaluation of the quality and safety of care. The ultimate goal is improved patient care and clinical outcomes through safer and better care for people with epilepsy in the EMU.
Topics: Adult; Aged; Aged, 80 and over; Consensus; Delphi Technique; Electroencephalography; Epilepsy; Humans; Middle Aged; Monitoring, Physiologic
PubMed: 27723937
DOI: 10.1111/epi.13563 -
International Journal of Environmental... Nov 2021This systematic review aims to summarise available patient-reported questionnaires to detect adverse drug reactions (ADRs) that can be utilised by healthcare... (Review)
Review
BACKGROUND
This systematic review aims to summarise available patient-reported questionnaires to detect adverse drug reactions (ADRs) that can be utilised by healthcare professionals in clinical practice and to summarise the psychometric properties (validity, reliability, and responsiveness) of the questionnaires.
METHODS
A systematic literature search was conducted using Medline, Pubmed, Embase, and Emcare databases to screen for articles published between January 2000 and July 2020. Data items regarding validity, reliability, and responsiveness were extracted independently by two authors. The methodological quality was assessed using the COSMIN (Consensus-Based Standards for the Selection of Health Measurement Instruments) checklist.
RESULTS
A total of 1563 unique article titles were identified after removing duplicates. Following shortlisting of relevant articles, 19 patient-reported ADR questionnaires were identified. Questionnaires most commonly focused on mental health medications (42.1%, = 8), followed by general questionnaires applicable to any medication (21.1%, = 4). Many questionnaires did not report assessing the validity and reliability of the measurement tool. For example, only 11 questionnaires (58%) mentioned assessing content validity, in addition to criterion or construct testing.
CONCLUSION
This systematic review summarised the available patient-reported questionnaires that can be used in research and clinical practice to identify ADRs. Results of this systematic review highlight the need for more robust validity and reliability testing when developing patient-reported ADR questionnaires.
Topics: Humans; Patient Reported Outcome Measures; Pharmaceutical Preparations; Psychometrics; Reproducibility of Results; Surveys and Questionnaires
PubMed: 34831635
DOI: 10.3390/ijerph182211877 -
PloS One 2018Patients are at risk for harm when treated simultaneously by healthcare providers from different healthcare organisations. To assess current practice and improvements of... (Review)
Review
BACKGROUND
Patients are at risk for harm when treated simultaneously by healthcare providers from different healthcare organisations. To assess current practice and improvements of transitional patient safety, valid measurement tools are needed.
AIM AND METHODS
To identify and appraise all measurement tools and outcomes that measure aspects of transitional patient safety, PubMed, Cinahl, Embase and Psychinfo were systematically searched. Two researchers performed the title and abstract and full-text selection. First, publications about validation of measurement tools were appraised for quality following COSMIN criteria. Second, we inventoried all measurement tools and outcome measures found in our search that assessed current transitional patient safety or the effect of interventions targeting transitional patient safety.
RESULTS
The initial search yielded 8288 studies, of which 18 assessed validity of measurement tools of different aspects of transitional safety, and 191 assessed current transitional patient safety or effect of interventions. In the validated measurement tools, the overall quality of content and structural validity was acceptable; other COSMIN criteria, such as reliability, measurement error and responsiveness, were mostly poor or not reported. In our outcome inventory, the most frequently used validated outcome measure was the Care Transition Measure (n = 9). The most frequently used non-validated outcome measures were: medication discrepancies (n = 98), hospital readmissions (n = 55), adverse events (n = 34), emergency department visits (n = 33), (mental or physical) health status (n = 28), quality and timeliness of discharge summary, and patient satisfaction (n = 23).
CONCLUSIONS
Although no validated measures exist that assess all aspects of transitional patient safety, we found validated measurement tools on specific aspects. Reporting of validity of transitional measurement tools was incomplete. Numerous outcome measures with unknown measurement properties are used in current studies on safety of care transitions, which makes interpretation or comparison of their results uncertain.
Topics: Humans; Patient Safety
PubMed: 29864119
DOI: 10.1371/journal.pone.0197312 -
Academic Emergency Medicine : Official... Aug 2015Overcrowding is a serious and ongoing challenge in Canadian hospital emergency departments (EDs) that has been shown to have negative consequences for patient outcomes.... (Review)
Review
OBJECTIVES
Overcrowding is a serious and ongoing challenge in Canadian hospital emergency departments (EDs) that has been shown to have negative consequences for patient outcomes. The American College of Emergency Physicians recommends observation/short-stay units as a possible solution to alleviate this problem. However, the most recent systematic review assessing short-stay units shows that there is limited synthesized evidence to support this recommendation; it is over a decade old and has important methodologic limitations. The aim of this study was to conduct a more methodologically rigorous systematic review to update the evidence on the effectiveness and safety of short-stay units, compared with usual care, on hospital and patient outcomes.
METHODS
A literature search was conducted using MEDLINE, the Cochrane Library, Embase, ABI/INFOM, and EconLit databases and gray literature sources. Randomized controlled trials of ED short-stay units (stay of 72 hours or less) were compared with usual care (i.e., not provided in a short-stay unit), for adult patients. Risk-of-bias assessments were conducted. Important decision-making (gradable) outcomes were patient outcomes, quality of care, utilization of and access to services, resource use, health system-related outcomes, economic outcomes, and adverse events.
RESULTS
Ten reports of five studies were included, all of which compared short-stay units with inpatient care. Studies had small sample sizes and were collectively at a moderate risk of bias. Most outcomes were only reported by one study and the remaining outcomes were reported by two to four studies. No deaths were reported. Three of the four included studies reporting length of stay found a significant reduction among short-stay unit patients, and one of the two studies reporting readmission rates found a significantly lower rate for short-stay unit patients. All four economic evaluations indicated that short-stay units were a cost-saving intervention compared to inpatient care from both hospital and health care system perspectives. Results were mixed for outcomes related to quality of care and patient satisfaction.
CONCLUSIONS
Insufficient evidence exists to make conclusions regarding the effectiveness and safety of short-stay units, compared with inpatient care.
Topics: Canada; Crowding; Emergency Service, Hospital; Health Services Accessibility; Humans; Length of Stay; Patient Safety; Quality of Health Care; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 26201285
DOI: 10.1111/acem.12730 -
BMJ Open Jan 2016To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility. (Review)
Review
OBJECTIVES
To systematically review interventions that aim to improve the governance of patient safety within emergency care on effectiveness, reliability, validity and feasibility.
DESIGN
A systematic review of the literature.
METHODS
PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Database of Systematic Reviews and PsychInfo were searched for studies published between January 1990 and July 2014. We included studies evaluating interventions relevant for higher management to oversee and manage patient safety, in prehospital emergency medical service (EMS) organisations and hospital-based emergency departments (EDs). Two reviewers independently selected candidate studies, extracted data and assessed study quality. Studies were categorised according to study quality, setting, sample, intervention characteristics and findings.
RESULTS
Of the 18 included studies, 13 (72%) were non-experimental. Nine studies (50%) reported data on the reliability and/or validity of the intervention. Eight studies (44%) reported on the feasibility of the intervention. Only 4 studies (22%) reported statistically significant effects. The use of a simulation-based training programme and well-designed incident reporting systems led to a statistically significant improvement of safety knowledge and attitudes by ED staff and an increase of incident reports within EDs, respectively.
CONCLUSIONS
Characteristics of the interventions included in this review (eg, anonymous incident reporting and validation of incident reports by an independent party) could provide useful input for the design of an effective tool to govern patient safety in EMS organisations and EDs. However, executives cannot rely on a robust set of evidence-based and feasible tools to govern patient safety within their emergency care organisation and in the chain of emergency care. Established strategies from other high-risk sectors need to be evaluated in emergency care settings, using an experimental design with valid outcome measures to strengthen the evidence base.
Topics: Emergency Medical Services; Feasibility Studies; Humans; Patient Safety; Reproducibility of Results
PubMed: 26826151
DOI: 10.1136/bmjopen-2015-009837 -
BMJ Quality & Safety Jul 2016Improving patient safety is at the forefront of policy and practice. While considerable progress has been made in understanding the frequency, causes and consequences of... (Review)
Review
IMPORTANCE
Improving patient safety is at the forefront of policy and practice. While considerable progress has been made in understanding the frequency, causes and consequences of error in hospitals, less is known about the safety of primary care.
OBJECTIVE
We investigated how often patient safety incidents occur in primary care and how often these were associated with patient harm.
EVIDENCE REVIEW
We searched 18 databases and contacted international experts to identify published and unpublished studies available between 1 January 1980 and 31 July 2014. Patient safety incidents of any type were eligible. Eligible studies were critically appraised using validated instruments and data were descriptively and narratively synthesised.
FINDINGS
Nine systematic reviews and 100 primary studies were included. Studies reported between <1 and 24 patient safety incidents per 100 consultations. The median from population-based record review studies was 2-3 incidents for every 100 consultations/records reviewed. It was estimated that around 4% of these incidents may be associated with severe harm, defined as significantly impacting on a patient's well-being, including long-term physical or psychological issues or death (range <1% to 44% of incidents). Incidents relating to diagnosis and prescribing were most likely to result in severe harm.
CONCLUSIONS AND RELEVANCE
Millions of people throughout the world use primary care services on any given day. This review suggests that safety incidents are relatively common, but most do not result in serious harm that reaches the patient. Diagnostic and prescribing incidents are the most likely to result in avoidable harm.
SYSTEMATIC REVIEW REGISTRATION
This systematic review is registered with the International Prospective Register of Systematic Reviews (PROSPERO CRD42012002304).
Topics: Humans; Medical Errors; Patient Safety; Primary Health Care
PubMed: 26715764
DOI: 10.1136/bmjqs-2015-004178 -
BMJ Open Jun 2017To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To evaluate the effect of capnography monitoring on sedation-related adverse events during procedural sedation and analgesia (PSA) administered for ambulatory surgery relative to visual assessment and pulse oximetry alone.
DESIGN AND SETTING
Systematic literature review and random effects meta-analysis of randomised controlled trials (RCTs) reporting sedation-related adverse event incidence when adding capnography to visual assessment and pulse oximetry in patients undergoing PSA during ambulatory surgery in the hospital setting. Searches for eligible studies published between 1 January 1995 and 31 December 2016 (inclusive) were conducted in PubMed, the Cochrane Library and EMBASE without any language constraints. Searches were conducted in January 2017, screening and data extraction were conducted by two independent reviewers, and study quality was assessed using a modified Jadad scale.
INTERVENTIONS
Capnography monitoring relative to visual assessment and pulse oximetry alone.
PRIMARY AND SECONDARY OUTCOME MEASURES
Predefined endpoints of interest were desaturation/hypoxaemia (the primary endpoint), apnoea, aspiration, bradycardia, hypotension, premature procedure termination, respiratory failure, use of assisted/bag-mask ventilation and death during PSA.
RESULTS
The literature search identified 1006 unique articles, of which 13 were ultimately included in the meta-analysis. Addition of capnography to visual assessment and pulse oximetry was associated with a significant reduction in mild (risk ratio (RR) 0.77, 95% CI 0.67 to 0.89) and severe (RR 0.59, 95% CI 0.43 to 0.81) desaturation, as well as in the use of assisted ventilation (OR 0.47, 95% CI 0.23 to 0.95). No significant differences in other endpoints were identified.
CONCLUSIONS
Meta-analysis of 13 RCTs published between 2006 and 2016 showed a reduction in respiratory compromise (from respiratory insufficiency to failure) during PSA with the inclusion of capnography monitoring. In particular, use of capnography was associated with less mild and severe oxygen desaturation, which may have helped to avoid the need for assisted ventilation.
Topics: Bradycardia; Capnography; Conscious Sedation; Deep Sedation; Humans; Monitoring, Physiologic; Oximetry; Patient Safety; Randomized Controlled Trials as Topic; Respiration, Artificial; Respiratory Insufficiency
PubMed: 28667196
DOI: 10.1136/bmjopen-2016-013402 -
Systematic Reviews Nov 2016The surgeon volume-outcome relationship has been discussed for many years and its existence or nonexistence is of importance for various reasons. A lot of empirical work... (Review)
Review
BACKGROUND
The surgeon volume-outcome relationship has been discussed for many years and its existence or nonexistence is of importance for various reasons. A lot of empirical work has been published on it. We aimed to summarize systematic reviews in order to present current evidence.
METHODS
Medline, Embase, Cochrane database of systematic reviews (CDSR), and health technology assessment websites were searched up to October 2015 for systematic reviews on the surgeon volume-outcome relationship. Reviews were critically appraised, and results were extracted and synthesized by type of surgical procedure/condition.
RESULTS
Thirty-two reviews reporting on 15 surgical procedures/conditions were included. Methodological quality of included systematic reviews assessed with the assessment of multiple systematic reviews (AMSTAR) was generally moderate to high albeit included literature partly neglected considering methodological issues specific to volume-outcome relationship. Most reviews tend to support the presence of a surgeon volume-outcome relationship. This is most clear-cut in colorectal cancer, bariatric surgery, and breast cancer where reviews of high quality show large effects.
CONCLUSIONS
When taking into account its limitations, this overview can serve as an informational basis for decision makers. Our results seem to support a positive volume-outcome relationship for most procedures/conditions. However, forthcoming reviews should pay more attention to methodology specific to volume-outcome relationship. Due to the lack of information, any numerical recommendations for minimum volume thresholds are not possible. Further research is needed for this issue.
Topics: Humans; Outcome Assessment, Health Care; Patient Safety; Quality of Health Care; Surgeons; Surgical Procedures, Operative
PubMed: 27899141
DOI: 10.1186/s13643-016-0376-4 -
Research in Social & Administrative... Jul 2023Unlicensed medicines are used across the UK to treat an individual's clinical needs when there are no appropriate licensed alternatives. Patients, carers and parents... (Review)
Review
BACKGROUND
Unlicensed medicines are used across the UK to treat an individual's clinical needs when there are no appropriate licensed alternatives. Patients, carers and parents have reported facing challenges with unlicensed medicines at the points of transfer of care between settings, a key time when medication errors may occur. There is little known about the patient journey as a whole, or the factors affecting patient care when receiving an unlicensed medicine.
OBJECTIVE
A systematic review of UK literature to better understand factors that affect the entire patient journey from the decision to initiate treatment with an unlicensed medicine to the point at which treatment is supplied through a community pharmacy or ends.
METHODS
Scopus, OVID EMCARE, EMBASE, OVID Medline ALL, CINAHL, Web of Science and Joanna Briggs Institute were searched from 1968 (introduction of the Medicines Act) until November 2020, using the PRISMA guidelines. Narrative synthesis of UK studies was employed to analyse descriptive and qualitative data on any reported findings that would impact the patient journey or care related to the use of unlicensed medicines, and any described barriers or enablers.
RESULTS
Forty-five studies met criteria for final inclusion, with high levels of heterogeneity in terms of designs and methods. Specific challenges that were seen to impact the continuity of care across care settings, patient safety and provision of patient-centred care included diversity of clinical needs and impact of patient population age; healthcare professional awareness and acceptability of the use of unlicensed medicines; the hierarchical structure of the NHS; inconsistent doses and formulations with varying bioequivalence; patient/parent/carer/public awareness of unlicensed medicines use and perceived acceptability.
CONCLUSIONS
This review identified a clear need for consistent information to be provided to healthcare professional and patients alike to support the safe and effective use of unlicensed medicines across care settings.
Topics: Humans; Patient Care; Health Personnel; Caregivers; Medicine; Medication Errors
PubMed: 37121796
DOI: 10.1016/j.sapharm.2023.04.120 -
PloS One 2016We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND AND AIM
We performed a systematic review and meta-analysis of all the available evidence comparing efficacy and safety of oral prolonged released beclomethasone dipropionate (BDP) to active oral controls in patients with mild-to-moderate ulcerative colitis (UC). A subgroup-analysis compared the effectiveness of BDP and 5-ASA.
METHODS
Literature research was performed in different databases, as well as manual search to identify abstracts from international meetings with data not included in extensive publications. Experts in the field and companies involved in BDP development and manufacture were contacted to identify unpublished studies used for registration purposes. Dichotomous data were pooled to obtain odds ratio meta-analysis.
RESULTS
Five randomized controlled trials that compared oral BDP 5mg/day vs. all oral active controls in treating UC were identified as eligible. Efficacy and safety have been addressed after 4-week treatment period. One study evaluated efficacy and safety of BDP vs. prednisone and 4 of BDP vs. 5-ASA. Treatment with oral BDP 5 mg/day induces a significant better clinical response compared to oral 5-ASA (OR 1.86, 95% CI = 1.23-2.82, P = 0.003). The effect is detectable even when the comparison to prednisone is added (OR 1.41, 95% CI = 1.03-1.93, P = 0.03). Data on remission indicate that the potential clinical efficacy of BDP may be better than 5-ASA (OR 1.55, 95% CI = 1.00-2.40, P = 0.05). This difference is lost when the comparison with prednisone is added (OR 1.30, 95% CI = 0.76-2.23, P = 0.34). The safety analysis showed no differences between BDP and 5-ASA (OR 0.55, 95% CI = 0.24-1.27, P = 0.16). The lack of difference is maintained even when the study with prednisone is added (OR 0.67, 95% CI = 0.44-1.01, P = 0.06). However, the trend of difference is clear and indicates a more favourable safety profile of BDP compared to 5-ASA and PD.
CONCLUSIONS
Oral prolonged release BDP showed a superior efficacy vs. oral 5-ASA in inducing clinical improvement of mild-to-moderate UC with a similar safety profile.
Topics: Administration, Oral; Anti-Inflammatory Agents, Non-Steroidal; Beclomethasone; Colitis, Ulcerative; Drug Administration Schedule; Humans; Mesalamine; Patient Safety; Prednisone; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 27846307
DOI: 10.1371/journal.pone.0166455