Resource Page

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

FDA MedWatch -

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amo

Inappropriate ED visits: patient responsibility or an attribution bias?

Quality and Safety in Health Care Journal -

The study by Naouri et al in this issue of BMJ Quality and Safety describes an ambitious, 24-hour cross-sectional physician survey and chart review of all the emergency departments (ED) in France to characterise the ‘inappropriateness’ of ED visits.1 The determination of inappropriateness for any given visit was based on (A) physician opinion, (B) physician determination of ambulatory care sensitivity, or (C) resource utilisation. Based on these measures, the authors concluded that between 13% and 27% of ED visits were inappropriate. Further, patients with supplemental public insurance (a proxy for the socioeconomic disadvantaged in France) were 15%–33% more likely to use the ED inappropriately.

Naouri’s study is part of a growing body of literature that characterises ED use as inappropriate, avoidable, ambulatory care sensitive or preventable.2 3 While there is precedent and potential merit in classifying healthcare services based on their value,4...

Emergency department shifts and decision to admit: is there a lever to pull to address crowding?

Quality and Safety in Health Care Journal -

Emergency department (ED) crowding has long been recognised as posing significant patient safety threats. Research has demonstrated ties between ED crowding and delays in time-sensitive, disease-specific interventions such as thrombolysis in patients with acute myocardial infarction1 and stroke,2 resuscitation in trauma patients,3 antibiotics for patients with community-acquired pneumonia,4 and more recently the timely treatment of patients with sepsis.5 Elderly patients in particular may be vulnerable to crowding.6 More broadly, it has become clear that periods of high ED crowding are associated with increased inpatient mortality, length of stay and costs,7 as well as decreased patient experience.8 9

Through health systems engineering, lean, and Six Sigma, ED leaders have sought to increase the efficiency of EDs, decrease crowding and improve the quality of care. Understanding the factors that contribute to ED crowding,...

Applying rigour to the interpretation of surgical site infection rates

Quality and Safety in Health Care Journal -

Surgical site infection (SSI) rates are closely scrutinised by hospital committees seeking to identify opportunities to prevent these important complications. In most hospitals, SSI rates are displayed as a monthly or quarterly incidence using a bar or line graph with comparison with the hospital’s historical rate or some external benchmark.

The response to these data is usually dichotomous. Hospital committee members may make congratulatory statements if the incidence is decreasing, or alternatively express concern that action is needed if there is an upward trend. Some hospitals even formalise these reactions with red-amber-green designations, ignoring chance variation.1 2 It is striking that in clinical research we would never automatically accept any difference as being significant without demanding a more rigorous statistical analysis. Yet, when it comes to quality improvement, the direction of the change alone is often enough to generate assertive conclusions about the state of...

Factors associated with inappropriate use of emergency departments: findings from a cross-sectional national study in France

Quality and Safety in Health Care Journal -

Background

Inappropriate visits to emergency departments (EDs) could represent from 20% to 40% of all visits. Inappropriate use is a burden on healthcare costs and increases the risk of ED overcrowding. The aim of this study was to explore socioeconomic and geographical determinants of inappropriate ED use in France.

Method

The French Emergency Survey was a nationwide cross-sectional survey conducted on June 11 2013, simultaneously in all EDs in France and covered characteristics of patients, EDs and counties. The survey included 48 711 patient questionnaires and 734 ED questionnaires. We focused on adult patients (≥15 years old). The appropriateness of the ED visit was assessed by three measures: caring physician appreciation of appropriateness (numeric scale), caring physician appreciation of whether or not the patient could have been managed by a general practitioner and ED resource utilisation. Descriptive statistics and multilevel logistic regression were used to examine determinants of inappropriate ED use, estimating adjusted ORs and 95% CIs.

Results

Among the 29 407 patients in our sample, depending on the measuring method, 13.5% to 27.4% ED visits were considered inappropriate. Regardless of the measure method used, likelihood of inappropriate use decreased with older age and distance from home to the ED >10 km. Not having a private supplementary health insurance, having universal supplementary health coverage and symptoms being several days old increased the likelihood of inappropriate use. Likelihood of inappropriate use was not associated with county medical density.

Conclusion

Inappropriate ED use appeared associated with socioeconomic vulnerability (such as not having supplementary health coverage or having universal coverage) but not with geographical characteristics. It makes us question the appropriateness of the concept of inappropriate ED use as it does not consider the distress experienced by the patient, and segments of society seem to have few other choices to access healthcare than the ED.

Later emergency provider shift hour is associated with increased risk of admission: a retrospective cohort study

Quality and Safety in Health Care Journal -

Background

Understanding factors that drive admissions is critical to containing cost and optimising hospital operations. We hypothesised that, due to multiple factors, emergency physicians would be more likely to admit a patient seen later in their shift.

Methods

Retrospective study examining all patient visits at a large academic hospital from July 2010 to July 2016. Patients with missing data (n=191) were excluded. 294 031 emergency department (ED) visits were included in the final analysis. The exposure of interest was the time during the shift at which a patient was first evaluated by the clinician, and outcome was hospital admission. We used a generalised estimating equation with physician as the clustering level to adjust for patient age, gender, Emergency Severity Index (ESI, 1=most severe illness, 5=least severe illness) and 24 hours clock time. We also conducted a stratified analysis by three ESI categories.

Results

From the 294 031 ED visits, 5977 were seen in the last hour of the shift. Of patients seen in the last shift hour, 43% were admitted versus 39% seen at any other time during the shift. There was a significant association between being evaluated in the last hour (RR 1.03, 95% CI 1.01 to 1.06) and last quarter (RR 1.02, 1.01 to 1.03) of shift and the likelihood of admission. Patients with an ESI Score of 4–5 saw the largest effect sizes (RR 1.62, 0.996–2.635 for last hour and RR 1.24, 0.996–1.535 for last quarter) but these were not statistically significant. Additionally, there was a trend towards increased likelihood of admission later in shift; the relative risk of admission was 1.04 in hour 6, (1.02–1.05), 1.03 in hour 7 (1.01–1.05), 1.04 in hour 8 (1.01–1.06) and 1.06 in hour 9 (1.013–1.101).

Conclusions

There is a small but significant association between a patient being evaluated later in an emergency physician’s shift and their likelihood of being admitted to the hospital.

Large-scale empirical optimisation of statistical control charts to detect clinically relevant increases in surgical site infection rates

Quality and Safety in Health Care Journal -

Objective

Surgical site infections (SSIs) are common costly hospital-acquired conditions. While statistical process control (SPC) use in healthcare has increased, limited rigorous empirical research compares and optimises these methods for SSI surveillance. We sought to determine which SPC chart types and design parameters maximise the detection of clinically relevant SSI rate increases while minimising false alarms.

Design

Systematic retrospective data analysis and empirical optimisation.

Methods

We analysed 12 years of data on 13 surgical procedures from a network of 58 community hospitals. Statistically significant SSI rate increases (signals) at individual hospitals initially were identified using 50 different SPC chart variations (Shewhart or exponentially weighted moving average, 5 baseline periods, 5 baseline types). Blinded epidemiologists evaluated the clinical significance of 2709 representative signals of potential outbreaks (out of 5536 generated), rating them as requiring ‘action’ or ‘no action’. These ratings were used to identify which SPC approaches maximised sensitivity and specificity within a broader set of 3600 individual chart variations (additional baseline variations and chart types, including moving average (MA), and five control limit widths) and over 32 million dual-chart combinations based on different baseline periods, reference data (network-wide vs local hospital SSI rates), control limit widths and other calculation considerations. Results were validated with an additional year of data from the same hospital cohort.

Results

The optimal SPC approach to detect clinically important SSI rate increases used two simultaneous MA charts calculated using lagged rolling baseline windows and 1 SD limits. The first chart used 12-month MAs with 18-month baselines and best identified small sustained increases above network-wide SSI rates. The second chart used 6-month MAs with 3-month baselines and best detected large short-term increases above individual hospital SSI rates. This combination outperformed more commonly used charts, with high sensitivity (0.90; positive predictive value=0.56) and practical specificity (0.67; negative predictive value=0.94).

Conclusions

An optimised combination of two MA charts had the best performance for identifying clinically relevant small but sustained above-network SSI rates and large short-term individual hospital increases.

Why colorectal screening fails to achieve the uptake rates of breast and cervical cancer screening: a comparative qualitative study

Quality and Safety in Health Care Journal -

Background

In Scotland, the uptake of clinic-based breast (72%) and cervical (77%) screening is higher than home-based colorectal screening (~60%). To inform new approaches to increase uptake of colorectal screening, we compared the perceptions of colorectal screening among women with different screening histories.

Methods

We purposively sampled women with different screening histories to invite to semistructured interviews: (1) participated in all; (2) participated in breast and cervical but not colorectal (‘colorectal-specific non-participants’); (3) participated in none. To identify the sample we linked the data for all women eligible for all three screening programmes in Glasgow, Scotland (aged 51–64 years; n=68 324). Interviews covered perceptions of cancer, screening and screening decisions. Framework method was used for analysis.

Results

Of the 2924 women invited, 86 expressed an interest, and 59 were interviewed. The three groups’ perceptions differed, with the colorectal-specific non-participants expressing that: (1) treatment for colorectal cancer is more severe than for breast or cervical cancer; (2) colorectal symptoms are easier to self-detect than breast or cervical symptoms; (3) they worried about completing the test incorrectly; and (4) the colorectal test could be more easily delayed or forgotten than breast or cervical screening.

Conclusion

Our comparative approach suggested targets for future interventions to increase colorectal screening uptake including: (1) reducing fear of colorectal cancer treatments; (2) increasing awareness that screening is for the asymptomatic; (3) increasing confidence to self-complete the test; and (4) providing a suggested deadline and/or additional reminders.

Using standardised patients to assess the quality of medical records: an application and evidence from rural China

Quality and Safety in Health Care Journal -

Background

Medical records play a fundamental role in healthcare delivery, quality assessment and improvement. However, there is little objective evidence on the quality of medical records in low and middle-income countries.

Objective

To provide an unbiased assessment of the quality of medical records for outpatient visits to rural facilities in China.

Methods

A sample of 207 township health facilities across three provinces of China were enrolled. Unannounced standardised patients (SPs) presented to providers following standardised scripts. Three weeks later, investigators returned to collect medical records from each facility. Audio recordings of clinical interactions were then used to evaluate completeness and accuracy of available medical records.

Results

Medical records were located for 210 out of 620 SP visits (33.8%). Of those located, more than 80% contained basic patient information and drug treatment when mentioned in visits, but only 57.6% recorded diagnoses. The most incompletely recorded category of information was patient symptoms (74.3% unrecorded), followed by non-drug treatments (65.2% unrecorded). Most of the recorded information was accurate, but accuracy fell below 80% for some items. The keeping of any medical records was positively correlated with the provider’s income (β 0.05, 95% CI 0.01 to 0.09). Providers at hospitals with prescription review were less likely to record completely (β –0.87, 95% CI –1.68 to 0.06). Significant variation by disease type was also found in keeping of any medical record and completeness.

Conclusion

Despite the importance of medical records for health system functioning, many rural facilities have yet to implement systems for maintaining patient records, and records are often incomplete when they exist. Prescription review tied to performance evaluation should be implemented with caution as it may create disincentives for record keeping. Interventions to improve record keeping and management are needed.

A mixed methods study examining teamwork shared mental models of interprofessional teams during hospital discharge

Quality and Safety in Health Care Journal -

Background

Little is known about how team processes impact providers’ abilities to prepare patients for a safe hospital discharge. Teamwork Shared Mental Models (teamwork-SMMs) are the teams’ organised understanding of individual member’s roles, interactions and behaviours needed to perform a task like hospital discharge. Teamwork-SMMs are linked to team effectiveness in other fields, but have not been readily investigated in healthcare. This study examines teamwork-SMMs to understand how interprofessional teams coordinate care when discharging patients.

Methods

This mixed methods study examined teamwork-SMMs of inpatient interprofessional discharge teams at a single hospital. For each discharge event, we collected data from the patient and their discharge team (nurse, physician and coordinator) using interviews and questionnaires. We quantitatively determined the discharge teams’ teamwork-SMM components of quality and convergence using the Shared Mental Model Scale, and then explored their relationships to patient-reported preparation for posthospital care. We used qualitative thematic analysis of narrative cases to examine the contextual differences of discharge teams with higher versus lower teamwork-SMMs.

Results

The sample included a total of 106 structured patient interviews, 192 provider day-of-discharge questionnaires and 430 observation hours to examine 64 discharge events. We found that inpatient teams with better teamwork-SMMs (ie, higher perceptions of teamwork quality or greater convergence) were more effective at preparing patients for post-hospital care. Additionally, teams with high and low teamwork-SMMs had different experiences with team cohesion, communication openness and alignment on the patient situation.

Conclusions

Examining the quality and agreement of teamwork-SMMs among teams provides a better understanding of how teams coordinate care and may facilitate the development of specific team-based interventions to improve patient care at hospital discharge.

Quality of care for acute abdominal pain in children

Quality and Safety in Health Care Journal -

Objective

To assess quality of care for children presenting with acute abdominal pain using validated indicators.

Design

Audit of care quality for acute abdominal pain according to 21 care quality indicators developed and validated in four stages.

Setting and participants

Medical records of children aged 1–15 years receiving care in 2012–2013 were sampled from 57 general practitioners, 34 emergency departments (ED) and 28 hospitals across three Australian states; 6689 medical records were screened for visits for acute abdominal pain and audited by trained paediatric nurses.

Outcome measures

Adherence to 21 care quality indicators and three bundles of indicators: bundle A-History; bundle B-Examination; bundle C-Imaging.

Results

Five hundred and fourteen children had 696 visits for acute abdominal pain and adherence was assessed for 9785 individual indicators. The overall adherence was 69.9% (95% CI 64.8% to 74.6%). Adherence to individual indicators ranged from 21.6% for assessment of dehydration to 91.4% for appropriate ordering of imaging. Adherence was low for bundle A-History (29.4%) and bundle B-Examination (10.2%), and high for bundle C-Imaging (91.4%). Adherence to the 21 indicators overall was significantly lower in general practice (62.7%, 95% CI 57.0% to 68.1%) compared with ED (86.0%, 95% CI 83.4% to 88.4%; p<0.0001) and hospital inpatient settings (87.9%, 95% CI 83.1% to 91.8%; p<0.0001).

Conclusions

There was considerable variation in care quality for indicator bundles and care settings. Future work should explore how validated care quality indicator assessments can be embedded into clinical workflows to support continuous care quality improvement.

Use of optimised dual statistical process control charts for early detection of surgical site infection outbreaks

Quality and Safety in Health Care Journal -

Introduction

Surgical site infections (SSI) are common healthcare-associated infections resulting in substantial morbidity, mortality and hospital costs.1–4 However, no standard algorithm for SSI surveillance or outbreak detection exists, and traditional surveillance techniques may fail to provide timely identification of important SSI rate increases.5 6 We previously showed that standard Shewhart and exponentially weighted moving average statistical process control (SPC) charts have potential to provide early detection of SSI outbreaks.7 We then performed a large-scale empirical optimisation study and determined that simultaneous use of two moving average (MA) SPC charts in this application was most effective in identifying clinically important increases in SSI rates, or SSI clusters, that occurred in our network of community hospitals.8 The objective of the current analysis was to evaluate the performance of this optimised combination of control charts...

When evidence says no: gynaecologists reasons for (not) recommending ineffective ovarian cancer screening

Quality and Safety in Health Care Journal -

Introduction

Most patients likely assume that physicians offer medical procedures backed by solid, scientific evidence that demonstrates their superiority—or at least non-inferiority—to alternative approaches.1 Doing otherwise would waste healthcare resources urgently needed elsewhere in the system and also would jeopardise patient health and safety as well as undermine patients’ trust in medicine2 and care. In some instances, however, physicians’ healthcare practices appear to act against scientific evidence.3–5 For example, evidence from two large randomised controlled trials6 7 on ovarian cancer screening’s effectiveness showed that the screening has no mortality benefits—neither cancer-specific nor overall—in average-risk women but considerable harms, including false-positive surgeries in women without ovarian cancer. Consequently, the US Preventive Services Task Force and medical associations worldwide recommend against ovarian cancer screening.8 Nevertheless, a considerable number of US gynaecologists persist in recommending...

Pages

Subscribe to Medication Safety Officers Society- MSOS aggregator - Resource Page