Ann-Marie Howell

Reducing the burden of surgical harm: a systematic review of the interventions used to reduce adverse events in surgery.

Objective:To perform a systematic review of interventions used to reduce adverse events in surgery. Background:Many interventions, which aim to improve patient safety in surgery, have been introduced to hospitals. Little is known about which methods provide a measurable decrease in morbidity and mortality. Methods:MEDLINE, EMBASE, and Cochrane databases were searched from inception to Week 19, 2012, for systematic reviews, randomized controlled trials (RCTs), and cross-sectional and cohort studies, which reported an intervention aimed toward reducing the incidence of adverse events in surgical patients. The quality of observational studies was measured using the Newcastle-Ottawa Scale. RCTs were assessed using the Cochrane Collaborations tool for assessing risk of bias. Results:Ninety-one studies met inclusion criteria, 26 relating to structural interventions, 66 described modifying process factors. Only 17 (of 42 medium to high quality studies) reported an intervention that produced a significant decrease in morbidity and mortality. Structural interventions were: improving nurse to patient ratios (P = 0.008) and Intensive Care Unit (ITU) physician involvement in postoperative care (P < 0.05). Subspecialization in surgery reduced technical complications (P < 0.01). Effective process interventions were submission of outcome data to national audit (P < 0.05), use of safety checklists (P < 0.05), and adherence to a care pathway (P < 0.05). Certain safety technology significantly reduced harm (P = 0.02), and team training had a positive effect on patient outcome (P = 0.001). Conclusions:Only a small cohort of medium- to high-quality interventions effectively reduce surgical harm and are feasible to implement. It is important that future research remains focused on demonstrating a measurable reduction in adverse events from patient safety initiatives.

How should perineal wounds be closed following abdominoperineal resection in patients post radiotherapy--primary closure or flap repair? Best evidence topic (BET).

This best evidence topic was investigated according to a described protocol. The question posed was: should the irradiated perineal wound following abdominoperineal resection (APR) be closed with primary repair or a myocutaneous flap. Using the reported search 364 papers were found of which eight represented the best evidence to answer the clinical question. The conclusion drawn is that there is some limited evidence for recommending flap closure in abdominoperineal resection post radiotherapy. The best evidence available was from a systematic review of cohort studies and case series. Although no meta-analysis was performed, overall wound healing was improved using flap closure with a low frequency of flap necrosis. Other studies providing evidence were case-control series or cohort studies. Three papers prospectively compared vertical rectus abdominus muscle (VRAM) flap with primary closure; two of which demonstrated statistically significant improvement in complication rates with flap closure. Two retrospective case control series showed significant improvement in major wound complication rates in the flap group. Two studies retrospectively compared gracilis flap repair with primary closure and showed significantly lower incidence of major perineal complications. Most studies suffered from significant limitations, small sample sizes and no direct comparisons between matched groups with respect to type of anatomic flap, wound size, tumour recurrence or radiation dose. Whilst there is evidence that myocutaneous flap closure following APR in radiotherapy patients can reduce wound related complications, prospective randomized controlled trials are warranted.

Risk of Post-Discharge Venous Thromboembolism and Associated Mortality in General Surgery: A Population-Based Cohort Study Using Linked Hospital and Primary Care Data in England

Background Trends towards day case surgery and enhanced recovery mean that postoperative venous thromboembolism (VTE) may increasingly arise after hospital discharge. However, hospital data alone are unable to capture adverse events that occur outside of the hospital setting. The National Institute for Health and Care Excellence has suggested the use of primary care data to quantify hospital care-related VTE. Data in surgical patients using these resources is lacking. The aim of this study was to measure VTE risk and associated mortality in general surgery using linked primary care and hospital databases, to improve our understanding of harm from VTE that arises beyond hospital stay. Methods This was a longitudinal cohort study using nationally linked primary care (Clinical Practice Research Datalink, CPRD), hospital administrative (Hospital Episodes Statistics, HES), population statistics (Office of National Statistics, ONS) and National Cancer Intelligence Network databases. Routinely collected information was used to quantify 90-day in-hospital VTE, 90-day post-discharge VTE and 90-day mortality in adults undergoing one of twelve general surgical procedures between 1st April 1997 and 31st March 2012. The earliest postoperative recording of deep vein thrombosis or pulmonary embolism in CPRD, HES and ONS was counted in each patient. Covariates from multiple datasets were combined to derive detailed prediction models for VTE and mortality. Limitation included the capture of VTE presenting to healthcare only and the lack of information on adherence to pharmacological thromboprophylaxis as there was no data linkage to hospital pharmacy records. Results There were 981 VTE events captured within 90 days of surgery in 168005 procedures (23.7/1000 patient-years). Overall, primary care data increased the detection of postoperative VTE by a factor of 1.38 (981/710) when compared with using HES and ONS only. Total VTE rates ranged between 3.2/1000 patient-years in haemorrhoidectomy to 118.3/1000 patient-years in esophagogastric resection. Predictors of VTE included emergency surgery (OR = 1.91 95%CI 1.60–2.28, p<0.001), age (OR = 1.02 95%CI 1.02–1.03, p<0.001), body mass index (OR = 1.03 95%CI 1.01–1.04, p<0.001), previous VTE (OR = 8.07 95%CI 6.61–9.83, p<0.001), length of stay (OR = 1.00 95%CI 1.00–1.00, p = 0.007) and cancer stages II (OR = 1.38 95%CI 1.03–1.87, p = 0.033), III (OR = 1.50 95%CI 1.11–2.01, p = 0.008) and IV (OR = 1.63 95%CI 1.03–2.59, p = 0.038). Major organ resections had the greatest odds of VTE when adjusted for other risk factors including length of hospital stay. Post-discharge VTE accounted for 64.8% (636/981) of all recorded VTE. In-hospital VTE (165.4/1000 patient-years) was recorded more frequently than post-discharge VTE (16.2/1000 patient-years). Both in-hospital (OR = 2.07 95%CI 1.51–2.85, p<0.001) and post-discharge (OR = 4.03 95%CI 2.95–5.51, p<0.001) VTE independently predicted 90-day mortality. In patients who died and VTE was recorded on HES or CPRD (n = 56), VTE was one of the causes of death in 37.5% (21/56) of cases. Conclusions A large proportion of postoperative VTE was detected in primary care. Evaluation of linked databases was a useful way of measuring postoperative VTE at population level. These resources identified a significant association between post-discharge VTE and mortality in general surgery.

Systematic review of the impact of surgical harm on quality of life after general and gastrointestinal surgery.

Objective:To assess the impact of surgical harm on quality of life (QoL) in general and gastrointestinal surgery. Background:Surgical adverse events (SAEs) are associated with poor outcome. Although SAEs are likely to affect QoL, this has not been demonstrated in surgery. Methods:Studies in general and gastrointestinal surgery measuring postoperative QoL in patients who suffered SAEs were identified. The overall impact of SAEs on QoL scores was determined by combining results from different studies. Component scores, adjustment for confounders, and time trends were evaluated. Results:Data from 57,058 patients in 31 studies were analyzed. Most studies assessed the combined effect of different SAEs. High-quality studies adjusted for preoperative QoL. When different QoL instruments were scaled down to a common 0 to 1 score, the mean difference in QoL between SAE and no-SAE patients was 0.140 in esophagectomy, 0.110 in the Crohn resection, 0.089 in colorectal resection, 0.085 in gastric bypass, 0.072 in cholecystectomy, and 0.060 in inguinal hernia repair. Studies evaluating ileal pouch formation and antireflux surgery showed conflicting results. SAEs did not significantly affect QoL in emergency laparotomy and pancreatectomy. The frequency of SAEs was 5% to 48%. Physical QoL was affected more than emotional QoL. Conclusions:Significantly negative effects of SAEs on QoL were demonstrated in a range of procedures. Postoperative QoL seems to be a surrogate for the severity of impact of SAEs on patients. QoL may be an important utility to evaluate the economic and societal impact of SAEs thereby defining the threshold for safe practice.

Can Patient Safety Incident Reports Be Used to Compare Hospital Safety? Results from a Quantitative Analysis of the English National Reporting and Learning System Data.

Background The National Reporting and Learning System (NRLS) collects reports about patient safety incidents in England. Government regulators use NRLS data to assess the safety of hospitals. This study aims to examine whether annual hospital incident reporting rates can be used as a surrogate indicator of individual hospital safety. Secondly assesses which hospital characteristics are correlated with high incident reporting rates and whether a high reporting hospital is safer than those lower reporting hospitals. Finally, it assesses which health-care professionals report more incidents of patient harm, which report more near miss incidents and what hospital factors encourage reporting. These findings may suggest methods for increasing the utility of reporting systems. Methods This study used a mix methods approach for assessing NRLS data. The data were investigated using Pareto analysis and regression models to establish which patients are most vulnerable to reported harm. Hospital factors were correlated with institutional reporting rates over one year to examine what factors influenced reporting. Staff survey findings regarding hospital safety culture were correlated with reported rates of incidents causing harm; no harm and death to understand what barriers influence error disclosure. Findings 5,879,954 incident reports were collected from acute hospitals over the decade. 70.3% of incidents produced no harm to the patient and 0.9% were judged by the reporter to have caused severe harm or death. Obstetrics and Gynaecology reported the most no harm events [OR 1.61(95%CI: 1.12 to 2.27), p<0.01] and pharmacy was the hospital location where most near-misses were captured [OR 3.03(95%CI: 2.04 to 4.55), p<0.01]. Clinicians were significantly more likely to report death than other staff [OR 3.04(95%CI: 2.43 to 3.80) p<0.01]. A higher ratio of clinicians to beds correlated with reduced rate of harm reported [RR = -1.78(95%Cl: -3.33 to -0.23), p = 0.03]. Litigation claims per bed were significantly negatively associated with incident reports. Patient satisfaction and mortality outcomes were not significantly associated with reporting rates. Staff survey responses revealed that keeping reports confidential, keeping staff informed about incidents and giving feedback on safety initiatives increased reporting rates [r = 0.26 (p<0.01), r = 0.17 (p = 0.04), r = 0.23 (p = 0.01), r = 0.20 (p = 0.02)]. Conclusion The NRLS is the largest patient safety reporting system in the world. This study did not demonstrate many hospital characteristics to significantly influence overall reporting rate. There were no association between size of hospital, number of staff, mortality outcomes or patient satisfaction outcomes and incident reporting rate. The study did show that hospitals where staff reported more incidents had reduced litigation claims and when clinician staffing is increased fewer incidents reporting patient harm are reported, whilst near misses remain the same. Certain specialties report more near misses than others, and doctors report more harm incidents than near misses. Staff survey results showed that open environments and reduced fear of punitive response increases incident reporting. We suggest that reporting rates should not be used to assess hospital safety. Different healthcare professionals focus on different types of safety incidents and focusing on these areas whilst creating a responsive, confidential learning environment will increase staff engagement with error disclosure.

International recommendations for national patient safety incident reporting systems: an expert Delphi consensus-building process

Background Patient safety incident reporting systems (PSRS) have been established for over a decade, but uncertainty remains regarding the role that they can and ought to play in quantifying healthcare-related harm and improving care. Objective To establish international, expert consensus on the purpose of PSRS regarding monitoring and learning from incidents and developing recommendations for their future role. Methods After a scoping review of the literature, semi-structured interviews with experts in PSRS were conducted. Based on these findings, a survey-based questionnaire was developed and subsequently completed by a larger expert panel. Using a Delphi approach, consensus was reached regarding the ideal role of PSRSs. Recommendations for best practice were devised. Results Forty recommendations emerged from the Delphi procedure on the role and use of PSRS. Experts agreed reporting system should not be used as an epidemiological tool to monitor the rate of harm over time or to appraise the relative safety of hospitals. They agreed reporting is a valuable mechanism for identifying organisational safety needs. The benefit of a national system was clear with respect to medication error, device failures, hospital-acquired infections and never events as these problems often require solutions at a national level. Experts recommended training for senior healthcare professionals in incident investigation. Consensus recommendation was for hospitals to take responsibility for creating safety solutions locally that could be shared nationally. Conclusions We obtained reasonable consensus among experts on aims and specifications of PSRS. This information can be used to reflect on existing and future PSRS, and their role within the wider patient safety landscape. The role of PSRS as instruments for learning needs to be elaborated and developed further internationally.

Development and validation of a symptom-based severity score for haemorrhoidal disease: the Sodergren score

One major obstacle in assessing the efficacy of treatment of haemorrhoids and the comparison of trials has been the lack of a standardized, validated symptom severity score. This study aimed to develop an objective, validated symptom‐based score of severity for haemorrhoids that can be used to compare treatments, monitor disease and assist in surgical decisions.

Incident reporting: rare incidents may benefit from national problem solving

We would like to congratulate the authors on the pragmatic nationwide approach that they have adopted in Denmark to address the key issues around incident reporting. Rabol and colleagues1 highlight again the challenges of collecting and meaningfully using such data. Though experts in Denmark have drawn many of the same conclusions reached in our Delphi exercise,2 it is interesting that our findings differed on the usefulness of incident reports to detect rare events. The Danish Society concluded that rare events are difficult to detect due to deficiencies in data mining and that efforts …

Harnessing clinical solving abilities through safety reporting to drive quality improvement in the NHS

Don Berwick presents a welcome and measured view on NHS workers who face increasing scrutiny over their ability to deliver high quality, safe healthcare. His latest report, insightfully distilled by McKee,1 recognises that the challenges faced are not unique to the UK and that blame must be diverted from those who flag safety concerns. Much emphasis has been placed on increasing transparency and accountability. The Danes …