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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 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:Objective:It 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. Methods:Secondary-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. Results:OA 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. Conclusion:The 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: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.

Project description:ObjectivesTo compare 10 year mortality rates among patients undergoing metal-on-metal hip resurfacing and total hip replacement in England.DesignRetrospective cohort study.SettingEnglish hospital episode statistics database linked to mortality records from the Office for National Statistics.PopulationAll adults who underwent primary elective hip replacement for osteoarthritis from April 1999 to March 2012. The exposure of interest was prosthesis type: cemented total hip replacement, uncemented total hip replacement, and metal-on-metal hip resurfacing. Confounding variables included age, sex, Charlson comorbidity index, rurality, area deprivation, surgical volume, and year of operation.Main outcome measuresAll cause mortality. Propensity score matching was used to minimise confounding by indication. Kaplan-Meier plots estimated the probability of survival up to 10 years after surgery. Multilevel Cox regression modelling, stratified on matched sets, described the association between prosthesis type and time to death, accounting for variation across hospital trusts.Results7437 patients undergoing metal-on-metal hip resurfacing were matched to 22,311 undergoing cemented total hip replacement; 8101 patients undergoing metal-on-metal hip resurfacing were matched to 24,303 undergoing uncemented total hip replacement. 10 year rates of cumulative mortality were 271 (3.6%) for metal-on-metal hip resurfacing versus 1363 (6.1%) for cemented total hip replacement, and 239 (3.0%) for metal-on-metal hip resurfacing versus 999 (4.1%) for uncemented total hip replacement. Patients undergoing metal-on-metal hip resurfacing had an increased survival probability (hazard ratio 0.51 (95% confidence interval 0.45 to 0.59) for cemented hip replacement; 0.55 (0.47 to 0.65) for uncemented hip replacement). There was no evidence for an interaction with age or sex.ConclusionsPatients with hip osteoarthritis undergoing metal-on-metal hip resurfacing have reduced mortality in the long term compared with those undergoing cemented or uncemented total hip replacement. This difference persisted after extensive adjustment for confounding factors available in our data. The study results can be applied to matched populations, which exclude patients who are very old and have had complex total hip replacements. Although residual confounding is possible, the observed effect size is large. These findings require validation in external cohorts and randomised clinical trials.

Project description:ObjectiveTo evaluate the impact of the 'Getting it Right First Time' (GIRFT) national improvement programme in orthopaedics, which started in 2012.DesignMixed-methods study comprising statistical analysis of linked national datasets (National Joint Registry; Hospital Episode Statistics; Patient-Reported Outcomes); economic analysis and qualitative case studies in six National Health Service (NHS) Trusts.SettingNHS elective orthopaedic surgery in England.Participants736 088 patients who underwent primary hip or knee replacement at 126 NHS Trusts between 1 April 2009 and 31 March 2018, plus 50 NHS staff.InterventionImprovement bundle including 'deep dive' visits by senior clinician to NHS Trusts, informed by bespoke set of routine performance data, to discuss how improvements could be made locally.Main outcome measuresNumber of procedures conducted by low volume surgeons; use of uncemented hip implants in patients >65; arthroscopy in year prior to knee replacement; hospital length of stay; emergency readmissions within 30 days; revision surgery within 1 year; health-related quality of life and functional status.ResultsNational trends demonstrated substantial improvements beginning prior to GIRFT. Between 2012 and 2018, there were reductions in procedures by low volume surgeons (ORs (95% CI) hips 0.58 (0.53 to 0.63), knees 0.77 (0.72 to 0.83)); uncemented hip prostheses in >65 s (OR 0.56 (0.51 to 0.61)); knee arthroscopies before surgery (OR 0.48 (0.41 to 0.56)) and mean length of stay (hips -0.90 (-1.00 to -0.81), knees -0.74 days (-0.82 to -0.66)). The additional impact of visits was mixed and comprised an overall economic saving of £431 848 between 2012 and 2018, but this was offset by the costs of the visits. Staff reported that GIRFT's influence ranged from procurement changes to improved regional collaboration.ConclusionNationally, we found substantial improvements in care, but the specific contribution of GIRFT cannot be reliably estimated due to other concurrent initiatives. Our approach enabled additional analysis of the discrete impact of GIRFT visits.

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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