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Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England.

ABSTRACT: OBJECTIVES:To provide accurate risk estimates of serious adverse events after elective shoulder replacement surgery for arthritis, including age and sex specific estimates of the lifetime risk of revision surgery. DESIGN:Population based cohort study. SETTING:Hospital episode statistics for NHS England, including civil registration mortality data. PARTICIPANTS:58?054 elective shoulder replacements in 51?895 adults (aged ?50 years) between April 1998 and April 2017. MAIN OUTCOME MEASURES:The lifetime risk of revision surgery, calculated using an actuarial life table approach and the cumulative probability method. Rates of serious adverse events at 30 and 90 days post-surgery: pulmonary embolism, myocardial infarction, lower respiratory tract infection, acute kidney injury, urinary tract infection, cerebrovascular events, and all cause death. Secondary outcome measures were the number of surgeries performed each year and Kaplan-Meier estimates of revision risk at 3, 5, 10, and 15 years. RESULTS:The number of shoulder replacements performed each year increased 5.6-fold between 1998 and 2017. Lifetime risks of revision surgery ranged from 1 in 37 (2.7%, 95% confidence interval 2.6% to 2.8%) in women aged 85 years and older to 1 in 4 (23.6%, 23.2% to 24.0%) in men aged 55-59 years. The risks of revision were highest during the first five years after surgery. The risk of any serious adverse event at 30 days post-surgery was 1 in 28 (3.5%, 3.4% to 3.7%), and at 90 days post-surgery was 1 in 22 (4.6%, 4.4% to 4.8%). At 30 days, the relative risk of pulmonary embolism compared with baseline population risk was 61 (95% confidence interval 50 to 73) for women aged 50-64. Serious adverse events were associated with increasing age, comorbidity, and male sex. 1 in 5 (21.2%, 17.9% to 25.1%) men aged 85 years and older experienced at least one serious adverse event within 90 days. CONCLUSIONS:Younger patients, particularly men, need to be aware of a higher likelihood of early failure of shoulder replacement and the need for further and more complex revision replacement surgery. All patients should be counselled about the risks of serious adverse events. These risks are higher than previously considered, and for some could outweigh any potential benefits. Our findings caution against unchecked expansion of shoulder replacement surgery in both younger and older patients. The more accurate age and sex specific estimates of risk from this study are long overdue and should improve shared decision making between patients and clinicians. STUDY REGISTRATION:ClinicalTrials.gov NCT03573765.

SUBMITTER: Craig RS

PROVIDER: S-EPMC6380386 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England.

Craig Richard S RS Lane Jennifer C E JCE Carr Andrew J AJ Furniss Dominic D Collins Gary S GS Rees Jonathan L JL

BMJ (Clinical research ed.) 20190220

<h4>Objectives</h4>To provide accurate risk estimates of serious adverse events after elective shoulder replacement surgery for arthritis, including age and sex specific estimates of the lifetime risk of revision surgery.<h4>Design</h4>Population based cohort study.<h4>Setting</h4>Hospital episode statistics for NHS England, including civil registration mortality data.<h4>Participants</h4>58 054 elective shoulder replacements in 51 895 adults (aged ≥50 years) between April 1998 and April 2017.<h ...[more]

PMID: 30786996

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Project description:ObjectiveTo provide clinicians and patients with accurate risk estimates of serious adverse events after common elective shoulder arthroscopic procedures, including reoperation within one year.DesignPopulation based cohort study.SettingHospital Episode Statistics for NHS England, including civil registration mortality data from the Office for National Statistics.Participants288 250 arthroscopic shoulder procedures performed in 261 248 patients aged ≥16 years between 1 April 2009 and 31 March 2017. Elective procedures were grouped into subacromial decompression, rotator cuff repair, acromioclavicular joint excision, glenohumeral stabilisation, and frozen shoulder release.Main outcome measuresThe primary outcomes were rates of serious adverse events (mortality, pulmonary embolism, pneumonia, myocardial infarction, acute kidney injury, stroke, and urinary tract infection) requiring inpatient care within 90 days post-surgery. Secondary outcomes were specific adverse event rates at 90 days, and reoperations (including for deep infection) within one year.ResultsThe overall rate of complications within 90 days after arthroscopic shoulder surgery (including reoperation) was low at 1.2% (95% confidence interval 1.2% to 1.3%), with one in 81 patients at risk, and varied according to type of procedure, from 0.6% (0.5% to 0.8%) for glenohumeral stabilisation to 1.7% (1.5% to 1.8%) for frozen shoulder release. After adjustment for age, comorbidities, and sex, no effect of procedure type was observed. Pneumonia was the most common adverse event (0.3%, 0.3% to 0.4%), with one in 303 patients at risk. Pulmonary embolic events were rare, at 0.1% (0.1% to 0.1%), with one in 1428 patients at risk. At one year, the overall rate for reoperation was 3.8% (3.8% to 3.9%), with one in 26 patients at risk, ranging from 2.7% (2.5% to 3.0%) for glenohumeral stabilisation to 5.7% (5.4% to 6.1%) for frozen shoulder release. The overall rate of further surgery for deep infection was low, at 0.1% (0.1% to 0.1%), with one in 1111 patients at risk, but was higher after rotator cuff repair (0.2%, 0.2% to 0.2%), with one in 526 patients at risk. Over the study period the number of arthroscopic shoulder procedures increased, except for subacromial decompression, which decreased.ConclusionsThe findings of this study suggest that risks of serious adverse events associated with common shoulder arthroscopy procedures are low. Nevertheless, serious complications do occur, and include the risk of reoperation in one in 26 patients within one year.Study registrationClinical.Trialsgov NCT03573765.

Project description:BackgroundThe aim of this study was to forecast future patient demand for shoulder replacement surgery in England and investigate any geographic and socioeconomic inequalities in service provision and patient outcomes.MethodsFor this cohort study, all elective shoulder replacements carried out by NHS hospitals and NHS-funded care in England from 1999 to 2020 were identified using Hospital Episode Statistics data. Eligible patients were aged 18 years and older. Shoulder replacements for malignancy or acute trauma were excluded. Population estimates and projections were obtained from the Office for National Statistics. Standardised incidence rates and the risks of serious adverse events (SAEs) and revision surgery were calculated and stratified by geographical region, socioeconomic deprivation, sex, and age band. Hospital costs for each admission were calculated using Healthcare Resource Group codes and NHS Reference Costs based on the National Reimbursement System. Projected rates and hospital costs were predicted until the year 2050 for two scenarios of future growth.ResultsA total of 77,613 elective primary and 5847 revision shoulder replacements were available for analysis. Between 1999 and 2020, the standardised incidence of primary shoulder replacements in England quadrupled from 2.6 to 10.4 per 100,000 population, increasing predominantly in patients aged over 65 years. As many as 1 in 6 patients needed to travel to a different region for their surgery indicating inequality of service provision. A temporal increase in SAEs was observed: the 30-day risk increased from 1.3 to 4.8% and the 90-day risk increased from 2.4 to 6.0%. Patients from the more deprived socioeconomic groups appeared to have a higher risk of SAEs and revision surgery. Shoulder replacements are forecast to increase by up to 234% by 2050 in England, reaching 20,912 procedures per year with an associated annual cost to hospitals of £235 million.ConclusionsThis study reports a rising incidence of shoulder replacements, regional disparities in service provision, and an overall increasing risk of SAEs, especially in more deprived socioeconomic groups. These findings highlight the need for better healthcare planning to match local population demand, while more research is needed to understand and prevent the increase observed in SAEs.

Project description:ObjectiveTo describe national reoperation rates after elective and emergency colorectal resection and to assess the feasibility of using reoperation as a quality indicator derived from routinely collected data in England.DesignRetrospective observational study of Hospital Episode Statistics (HES) data.SettingHES dataset, an administrative dataset covering the entire English National Health Service.ParticipantsAll patients undergoing a primary colorectal resection in England between 2000 and 2008.Main outcome measuresReoperation after colorectal resection, defined as any reoperation for an intra-abdominal procedure or wound complication within 28 days of surgery on the index or subsequent admission to hospital.ResultsThe national reoperation rate was 6.5% (15,986/246,469). A large degree of variation was identified among institutions and surgeons. Even among institutions and surgical teams with high caseloads, threefold and fivefold differences in reoperation rates were observed between the highest and lowest performing trusts and surgeons. Of the NHS trusts studied, 14.1% (22/156) had adjusted reoperation rates above the upper 99.8% control limit. Factors independently associated with higher risk of reoperation were diagnosis of inflammatory bowel disease (odds ratio 1.33 (95% CI 1.24 to 1.42), P<0.001), presence of multiple comorbidity (odds ratio 1.34 (1.29 to 1.39), P<0.001), social deprivation (1.14 (1.08 to 1.20) for most deprived, P<0.001), male sex (1.33 (1.29 to 1.38), P<0.001), rectal resection (1.63 (1.56 to 1.71), P<0.001), laparoscopic surgery (1.11 (1.03 to 1.20), P = 0.006), and emergency admission (1.21 (1.17 to 1.26), P<0.001).ConclusionsThere is large variation in reoperation after colorectal surgery between hospitals and surgeons in England. If data accuracy can be assured, reoperation may allow performance to be checked against national standards from current routinely collected data, alongside other indicators such as mortality.

Project description:IntroductionPrimary total elbow replacement (TER) services in England are being restructured with the goal of centralising care to specialised centres. It is important to monitor the impact of this service redesign. This protocol outlines an intended analysis to provide detailed descriptions of the patients who are receiving primary TER, where and by whom TER is being performed, and what the current surgical practices for TER are in England before the reconfiguration.MethodsThis analysis will use the National Joint Registry (NJR) elbow dataset and link it with NHS England Hospital Episode Statistics-Admitted Patient Care (HES-APC). It will include eligible patients from the start of the NJR elbow dataset in April 2012 to December 2022. The main objective is to determine the incidence of TER in England. Age-sex standardised rates will be calculated for groups including different ethnicities, and socioeconomic backgrounds, using the mid-year population data provided by the Office for National Statistics. This planned analysis will summarise patient characteristics such as age, sex, body mass index (BMI), hand dominance, American Society of Anaesthesiologists (ASA) grade, indication for TER, socioeconomic status, and patient co-morbidities. It will also examine implant fixation type, classification, brand/type, and changes over time in implant types used in England. Additionally, it will explore the characteristics and volume of the surgeons and hospitals providing primary TER services, including the grade of the primary surgeons, funding source for surgery, and admission type. The analysis will cover the number of procedures performed by surgeons and hospitals annually in England and in each region of England. Finally, the planned analysis will summarise the elective wait time, postoperative length of stay, and any serious adverse events or re-admissions within 30 and 90 days after the TER.DiscussionThis protocol describes the first deep dive analysis into the NJR elbow dataset to describe the incidence of TER surgery in England and the characteristics of patients who are receiving it. This analysis will summarise current primary TER practices in England before service reconfigurations. The impact of reconfiguration can be monitored by comparing future practice to the outcomes from this study. Trial registration ClinicalTrials.gov, NCT06355011. Registered 02 April 2024, https://clinicaltrials.gov/ct2/show/NCT06355011 .

Project description:BackgroundArthroscopic partial meniscectomy is one of the most common orthopaedic procedures worldwide. Clinical trial evidence published in the past 6 years, however, has raised questions about the effectiveness of the procedure in some patient groups. In view of concerns about potential overuse, we aimed to establish the true risk of serious complications after arthroscopic partial meniscectomy.MethodsWe analysed national Hospital Episode Statistics data for all arthroscopic partial meniscectomies done in England between April 1, 1997, and March 31, 2017. Simultaneous or staged (within 6 months) bilateral cases were excluded. We identified complications occurring in the 90 days after the index procedure. The primary outcome was the occurrence of at least one serious complication within 90 days, which was defined as either myocardial infarction, stroke, pulmonary embolism, infection requiring surgery, fasciotomy, neurovascular injury, or death. Logistic regression modelling was used to identify factors associated with complications and, when possible, risk was compared with general population data.FindingsDuring the study period 1 088 782 arthroscopic partial meniscectomies were done, 699 965 of which were eligible for analysis. Within 90 days, serious complications occurred in 2218 (0·317% [95% CI 0·304-0·330]) cases, including 546 pulmonary embolisms (0·078% [95% CI 0·072-0·085]) and 944 infections necessitating further surgery (0·135% [95% CI 0·126-0·144]). Increasing age (adjusted odds ratio [OR] 1·247 per decade [95% CI 1·208-1·288) and modified Charlson comorbidity index (adjusted OR 1·860 per 10 units [95% CI 1·708-2·042]) were associated with an increased risk of serious complications. Female sex was associated with a reduced risk of serious complications (adjusted OR 0·640 [95% CI 0·580-0·705). The risk of mortality fell over time (adjusted OR 0·965 per year [95% CI 0·937-0·994]). Mortality, myocardial infarction, and stroke occurred less frequently in the study cohort than in the general population. The risks of infection and pulmonary embolism did not change during the study, and were significantly higher in the study cohort than in the general population. For every 1390 (95% CI 1272-1532) fewer knee arthroscopies done, one pulmonary embolism could be prevented. For every 749 (95% CI 704-801) fewer procedures done, one native knee joint infection could be prevented.InterpretationOverall, the risk associated with undergoing arthroscopic partial meniscectomy was low. However, some rare but serious complications (including pulmonary embolism and infection) are associated with the procedure, and the risks have not fallen with time. In view of uncertainty about the effectiveness of arthroscopic partial meniscectomy, an appreciation of relative risks is crucial for patients and clinicians. Our data provide a basis for decision making and consent.FundingUK National Institute for Health Research.

Project description:ObjectiveIt is typical in epidemiological research of osteoarthritis (OA) to collect data for the hand, hip, and knee. However, little population-based data exist for this disease in the foot. Thus, we addressed patterns of OA for the foot compared with the hand, hip, and knee spanning 2000/2001 to 2017/2018 in England.MethodsSecondary-care data from 3 143 928 patients with OA of the foot, hand, hip, and knee were derived from the National Health Service (NHS) Hospital Episode Statistics (HES) database. Distribution, population prevalence, and incidence of joint-specific OA were stratified by age and sex.ResultsOA incidence increased significantly at the foot [3.8% (95% confidence interval [CI] 3.0, 4.6)], hand [10.9% (10.1, 11.7)], hip [3.8% (2.9, 4.7)], and knee [2.9% (2.2, 3.6)] per year from 2000/2001 to 2017/2018. A higher proportion of women were diagnosed with OA, whereas greater incidence in men was estimated for the hand and hip. Foot OA presented comparable diagnosis numbers to the hand. More recently during 2012/2013 to 2017/2018, a significant rise in hip OA was estimated among younger adults, whereas knee OA decreased across all age groups. Incidence of OA in the foot and hand were particularly significant among the 75 or older age group, though bimodal age distributions were observed for both sites.ConclusionThe significant increase in secondary care records for OA in England underscores the importance of exploring possible causative factors and identifying groups most at risk. Further detailed data may be particularly important for the hip, which represents significant incidence among younger adults. Greater incidence of OA in the foot compared with the knee emphasizes the need for well-conducted epidemiological research in this area. Monitoring the performance of surgical outcomes at the population-level for this frequently affected yet understudied site could have substantial potential to reduce the socioeconomic burden it represents to the NHS.

Project description:ObjectivesTo investigate the impact of COVID-19 on the burden of hospital-treated Aspergillus and Candida infections in England.DesignA retrospective study using Hospital Episodes Statistics data to estimate the burden of serious and invasive fungal infections (SIFIs) in all patients admitted in England during March 2018-February 2020 (pre-COVID-19) and during March 2020-October 2021 (the COVID-19 period).SettingHospitals in England.PopulationAll patients with codes corresponding to serious and invasive aspergillosis and candidiasis in any diagnosis position during their admission pre-COVID-19 and during the COVID-19 period.Outcome measuresAge, spells, patient counts, mean length of stay, admission to critical care unit (CCU), length of stay in CCU, 30-day readmissions, failed discharges (readmission within 7 days) and comorbidities.ResultsDuring the COVID-19 period, hospitalisation spells with an invasive candidiasis code fell by 3.2% and spells with an aspergillosis code by 24.8%. Mean length of stay was higher for patients with aspergillosis with or without COVID-19 and candidiasis with or without COVID-19 during the pandemic than before the pandemic. During the pandemic, mean length of stay was higher for patients with aspergillosis with COVID-19 than those with aspergillosis alone but slightly lower for patients with candidiasis with COVID-19 than for those with candidiasis alone. Of patients with a diagnosis of COVID-19, 52.5% with aspergillosis and 60.0% with candidiasis were treated in CCU compared with 13.2% and 37.1%, respectively, without a COVID-19 diagnosis. The percentage of 30-day readmissions and failed discharges for patients with SIFI was higher for those with COVID-19 than for those without.ConclusionsThe burden of aspergillosis and candidiasis has been affected by COVID-19. Aspergillosis diagnoses fell among hospitalised patients during the pandemic, while candidiasis continued to fluctuate in patterns similar to pre-COVID-19. A higher burden for patients with SIFI was observed, whether or not they also had a diagnosis of COVID-19. Our findings highlight extra considerations and burden on management of serious SIFI as a result of the COVID-19 pandemic.

Project description:BackgroundCarpal tunnel decompression surgery to treat carpal tunnel syndrome is a common procedure, yet data on safety and effectiveness of the operation in the general population remain scarce. We aimed to estimate the incidence of reoperation and serious postoperative complications (requiring admission to hospital or further surgery) following carpal tunnel decompression in routine clinical practice and to identify the patient factors associated with these adverse outcomes.MethodsWe did a nationwide cohort analysis including all carpal tunnel decompression surgeries in patients aged 18 years or older, done in the National Health Service in England between April 1, 1998, and March 31, 2017, using the Hospital Episode Statistics dataset linked to mortality records. Patients were followed-up until death or until the end of the study (March 31, 2017). Primary outcomes were the overall incidence of carpal tunnel decompression reoperation and serious postoperative complications (surgical site infection or dehiscence, or neurovascular or tendon injury, requiring admission to hospital or further surgery) within 30 days and 90 days after surgery. Multivariable Cox regression analysis was used to identify factors influencing complications and reoperation, and the Fine and Gray method was used to adjust for the competing risk of mortality. This study is registered with ClinicalTrials.gov, NCT03573765.Findings855 832 carpal tunnel decompression surgeries were done between April 1, 1998, and March 31, 2017 (incidence rate 1·10 per 1000 person-years [95% CI 1·02-1·17]). 29 288 procedures (3·42%) led to carpal tunnel decompression reoperation (incidence rate 3·18 per 1000 person-years [95% CI 3·12-3·23]). Of the 855 832 initial surgeries, 620 procedures (0·070% [95% CI 0·067-0·078]) led to a serious complication within 30 days after surgery, and 698 procedures (0·082% [0·076-0·088]) within 90 days. Local complications within 90 days after surgery were associated with male sex (adjusted hazard ratio 2·32 [95% CI 1·74-3·09]) and age category 18-29 years (2·25 [1·10-4·62]). Male sex (adjusted subhazard ratio 1·09 [95% CI 1·06-1·13]), old age (>80 years vs 50-59 years: 1·09 [1·03-1·15]), and greater levels of comorbidity (Charlson score ≥5 vs 0: 1·25 [1·19-1·32]) and socioeconomic deprivation (most deprived 10% vs least deprived 10%: 1·18 [1·10-1·27]) were associated with increased reoperation risk.InterpretationTo our knowledge, this is the largest national study on carpal tunnel decompression to date, providing strong evidence on serious postoperative complication and reoperation rates. Carpal tunnel decompression appears to be a safe operation in most patients, with an overall serious complication rate (requiring admission to hospital or further surgery) of less than 0·1%.FundingVersus Arthritis; Medical Research Council; Royal College of Surgeons of England and National Joint Registry research fellowship; University of Oxford; National Institute for Health Research; and National Institute for Health Research Biomedical Research Centre, Oxford.

Dataset Information

Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England.

Publications

Serious adverse events and lifetime risk of reoperation after elective shoulder replacement: population based cohort study using hospital episode statistics for England.

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