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

BMJ ◽  
2019 ◽  
pp. l298 ◽  
Author(s):  
Richard S Craig ◽  
Jennifer C E Lane ◽  
Andrew J Carr ◽  
Dominic Furniss ◽  
Gary S Collins ◽  
...  
Keyword(s):  
Adverse Events ◽  
Revision Surgery ◽  
Population Based ◽  
Hospital Episode Statistics ◽  
Lifetime Risk ◽  
Shoulder Replacement ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Replacement Surgery ◽  
Post Surgery

AbstractObjectivesTo 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.DesignPopulation based cohort study.SettingHospital episode statistics for NHS England, including civil registration mortality data.Participants58 054 elective shoulder replacements in 51 895 adults (aged ≥50 years) between April 1998 and April 2017.Main outcome measuresThe 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.ResultsThe 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.ConclusionsYounger 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 registrationClinicalTrials.govNCT03573765.

scholarly journals Procedural Pain and Serious Adverse Events with Bone Marrow Aspiration and Biopsy: Real World Experience from India

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 38-38
Author(s):  
Chepsy C Philip ◽  
Inderjit Singh ◽  
Rachel Thaper ◽  
Alice David ◽  
Suvir Singh ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Adverse Event ◽  
Adverse Events ◽  
Pain Perception ◽  
Bone Marrow Aspiration ◽  
Procedural Pain ◽  
Routine Practice ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Factors Associated

Background: Bone Marrow aspiration and Biopsy (BMAB) is perceived by patients as a painful procedure with fearsome complications. Though informed as safe and well tolerated; there is limited data about the complications and degree of pain experienced by patients undergoing BMAB.[1] Further scarce is data from the developing world where procedural fear discourages patients from pursuing treatment and diagnosis.[2] Methods Aims: To estimate the level of pain and frequency of serious adverse eventsexperienced by patients undergoing BMAB at our center. We also attempted to identify factors associated with increased pain perception. Study setting: This study was conducted at a tertiary level teaching hospital, the Christian Medical College & Hospital, Ludhiana. Ethics approval was obtained from the Institutional research committee (CMC/1495). Study period: 01 April 2015 through 30 Nov 2019 Study Design: This is a comparative cross sectional study where comparison of those with relatively more pain to those with less was done to elicit the factors associated with pain perception. Study Population: All consecutive patients who underwent a BMAB and provided informed consent which was taken pre-procedure, were included. We excluded patients who underwent the procedure under general anesthesia. Logistics of the Study: The BMAB was performed variably by Consultant Physicians, Trainee Physicians and Physician Assistants. All patients were pre-medicated with tramadol intravenous pre-procedure, and the preferred approach was from the posterior superior iliac spine (PSIS) in a left lateral decubitus under local anesthesia with lignocain. Patients were sent home or returned to their ward after upto 60 minutes of observation. A serious adverse event was considered as one requiring a prolonged observation beyond routine practice or extending to an admission to manage adverse events following and related to the BMAB. Data sources and variables Information regarding age at diagnosis, address and sex, indication to perform the BMAB, coded as malignant and non-malignant was collected from each patient. Number of prior procedures and details regarding food intake were collected as recalled by the patient. Level of pain was noted soon after the BMAB using a combined Wong-Baker grimace with numeric pain scale by the patient themselves. Statistical Analysis: Descriptive statistics were used to characterize variables. Univariate and Multivariate Logistic Regression were used to identify factors associated with higher pain severity (Score >2). Results: A total of 942 BMAB procedures were performed in this period. Baseline characteristics as tabulated below (Table1). Although the Mean + SD pain score was only 2.7 + 1.39, fourteen patients (1.48%) reported severe pain (>8). The following risk-factors were associated with increased pain on multivariate analysis: those experiencing their first BMAB procedure had very low odds of pain (OR (95 % CI): 0.23 (0.15-0.37)). However, when more than one attempt of biopsy was made, the odds of pain was much higher (OR (95 % CI): 1.62 (1.29-2.05)). Food and drink intake prior to procedure was associated only at the univariate level. Those who did not take any food prior to procedure had very high odds of pain (odds ratio (OR) 1.81 (95 % CI 1.01-3.22)). However, those who took juice had very low odds (OR (95 % CI): 0.619 (0.43-0.90)). Nine (0.95%) serious adverse events were reported. There were no deaths. The major serious adverse event was hemorrhage resulting from pseudo-aneurysm of the posterior iliac artery, which comprised 2 of the 9 serious adverse events. Other serious adverse events included persistent vomiting and severe aching pain in the ipsilateral leg. Conclusions: In our analysis BMAB is associated with a low level of procedural pain and is safe. The pain perception was not influenced by the operator. Factors associated with decreased pain perception were first procedural BMAB experience and successful completion of the procedure in the first attempt. Having at least a snack or a juice pre-procedure could reduce pain perception. Serious adverse events are rare in our experience. Disclosures No relevant conflicts of interest to declare.

scholarly journals A137 COLONOSCOPY RELATED ADVERSE EVENTS IN A POPULATION-BASED COLON SCREENING PROGRAM

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 158-159
Author(s):  
M Tomaszewski ◽  
D Sanders ◽  
R A Enns ◽  
L Gentile ◽  
C Nash ◽  
...  
Keyword(s):  
Adverse Events ◽  
Chart Review ◽  
Screening Program ◽  
Population Based ◽  
Serious Adverse Events ◽  
Screening Programs ◽  
Medical Visits ◽  
Admission Data ◽  
Respiratory Event ◽  
Event Rates

Abstract Background The British Columbia Colon Screening Program (BCCSP) is a population-based program enrolling 50–74 year old individuals for biennial FIT (OC-Sensor, cut-off 10 mcg/g) with follow-up colonoscopy for positive FIT. The neoplasia detection rate is 50–55% and over 75% of colonoscopies have a specimen taken. Previously reported colonoscopy adverse event rates for FIT based screening programs vary widely: 0.03–6.2% and 0–2.7% for bleeding and perforation, respectively. Mortality as a result of colonoscopy is rare but has been reported in 0.0004%-0.0074% of colonoscopies. The rate of colonoscopy related adverse events in BCCSP participants is unknown. Aims To determine the rate of colonoscopy related serious adverse events within the BCCSP. Methods This is a retrospective cohort study of all participants undergoing colonoscopy in BCCSP from November 15, 2013 to December 31, 2017. BCCSP contacts screening participants by phone 14 days post colonoscopy to determine unplanned medical visits the day prior (during bowel preparation) or following the colonoscopy. Unplanned events underwent chart review if the event was a perforation, cardiovascular or respiratory event, or resulted in death, hospitalization, or significant intervention including repeat colonoscopy, interventional radiology, surgery, blood transfusion, cardioversion, casting of a fracture or suturing of a laceration. Chart review was conducted by a Colonoscopy Lead and reviewed by BCCSP Quality Committee. Unplanned events were defined as serious adverse events (SAE) if they resulted in death, hospitalization or significant intervention and further classified as probably, possibly, or unlikely related to the colonoscopy. Results A total of 108,004 colonoscopies were performed. Unplanned events were reported in 1753 participants, of which 586 met criteria for review. Of these, 578 were confirmed unplanned events and 409 were SAEs of which 367 (89.7%) were probably, 22 (5.4%) possibly and 20 (4.9%) unlikely associated with colonoscopy. 36/10,000 colonoscopies were associated with a SAE that was probably or possibly related: perforation in 5/10,000, bleeding 22/10,000. Three deaths occurred in the 14 days following colonoscopy that were probably (2 perforations) or possibly related to the colonoscopy (0.3/10,000). Conclusions The BCCSP has a colonoscopy SAE rate in keeping with previous publications, particularly in the context of a very high proportion of procedures associated with polypectomy, a known risk factor for perforation and bleeding. This study will help inform screening participants about the risks of colonoscopy in the BC program. Future studies are required to confirm these rates using hospital admission data. Funding Agencies None

Outcomes of day case shoulder replacement surgery in a stand-alone day care unit in the United Kingdom

2022 ◽  
pp. 175857322110708
Author(s):  
Mosab Elgalli ◽  
Jamie Hind ◽  
Ian Lahart ◽  
Gur Aziz Singh Sidhu ◽  
Sajjad Athar ◽  
...  
Keyword(s):  
Shoulder Arthroplasty ◽  
Care Pathway ◽  
Surgical Care ◽  
Operation Time ◽  
District General Hospital ◽  
Shoulder Replacement ◽  
Day Case ◽  
Replacement Surgery ◽  
Post Surgery ◽  
Significant Difference

Background: This review aims to compare the outcomes for day case shoulder replacement with in-patient shoulder replacement surgery in a district general hospital. Methods: Seventy-three patients had 82 shoulder arthroplasty procedures. Forty-six procedures were undertaken in a dedicated stand-alone day-case unit and 36 were undertaken as in-patient cases. Patient were followed up at 6 weeks, 6 months and annually. Results: There was no significant difference between the outcomes of shoulder arthroplasty procedures performed in the day case or in-patient settings making this a safe option for surgical care in a unit with an appropriate care pathway. Six complications in total were observed, three in each group. Operation time was statistically shorter for day cases by 25.1 min (95% CI - 36.5 to −13.7; d = −0.95, 95% CI −1.42 to 0.48). Estimated marginal means (EMM) revealed lower post-surgery oxford pain scores in day cases (EMM = 3.25, 95% CI 2.35, 4.16) compared with inpatients (EMM = 4.65, 95% CI 3.64 to 5.67). Constant shoulder scores were higher in day cases versus inpatients. Conclusion: Day case shoulder replacement is safe with comparable outcomes to routine inpatient care for patients up to ASA 3 classification with high satisfaction and excellent functional outcomes.

A Cumulative Review of the Range and Incidence of Significant Adverse Events Associated with Acupuncture

2004 ◽  
Vol 22 (3) ◽  
pp. 122-133 ◽  
Author(s):  
Adrian White
Keyword(s):  
Adverse Events ◽  
Case Reports ◽  
Central Nervous System Infection ◽  
Auricular Acupuncture ◽  
External Ear ◽  
Serious Adverse Events ◽  
Medical Treatments ◽  
Serious Adverse Event ◽  
The Central Nervous System ◽  
Common Infection

Objective To summarise the range and frequency of significant adverse events associated with acupuncture in order to provide evidence on which to base continuing efforts to improve the safety of acupuncture practice. Methods Searches were conducted of computerised databases, previous reviews of case reports, population surveys, prospective surveys of acupuncture practice and relevant sections of textbooks for primary and secondary reports to indicate the range of significant adverse events associated with acupuncture. Data from prospective surveys of acupuncture were combined to estimate the incidence of serious adverse events. Results A total of 715 adverse events was included. There were 90 primary reports of trauma, and 186 secondary reports; the most common were pneumothorax and injury to the central nervous system. Infection accounted for 204 primary reports and 91 secondary reports. Over 60% of these cases were hepatitis B. The next most common infection was of the external ear, as a complication of auricular acupuncture. The 144 miscellaneous events mainly comprised seizures and drowsiness judged severe enough to cause a traffic hazard. There were 12 primary reports of deaths. According to the evidence from 12 prospective studies which surveyed more than a million treatments, the risk of a serious adverse event with acupuncture is estimated to be 0.05 per 10 000 treatments, and 0.55 per 10 000 individual patients. Conclusions The risk of serious events occurring in association with acupuncture is very low, below that of many common medical treatments. The range of adverse events reported is wide and some events, specifically trauma and some episodes of infection, are likely to be avoidable.

scholarly journals QT changes of unforeseen implications and bedaquiline: an observational study

2020 ◽  
Author(s):  
Sandip Mukhopadhyay ◽  
Samya Dutta ◽  
Rupam Ta
Keyword(s):  
Adverse Events ◽  
Observational Study ◽  
Real World ◽  
Adverse Reactions ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
The Real ◽  
Baseline Values ◽  
Access Program

Background: Bedqauiline (BDQ) is a relatively new agent for multidrug (MDR) and extremely drug resistant (XDR) TB. It is important to look for cardiac safety and the bizarre adverse reactions after initiation of the drugs from the real world studies. Methods: An observational study was conducted on the institutionalized MDR and XDR patients under the conditional access program of BDQ in India. Daily ECG, adverse events and change in laboratory values for first two weeks were recorded with mortality and serious adverse events till first three months of initiation of BDQ containing regimen. Results: Among the total of 49 patients, nausea (n=33) was the most reported side effect. Though a mean rise of QTcF (12%) was noted after 14 days, individually, both prolongations (QTcF >440 ms) and shortening (from baseline values) of QTcF were noted in 95.92% (n=47) and 89.8% (n=44) patients. Three distinct QT patterns noted in ECG were, a) initial rise then fall (n=8), b) initial fall then rise (n=9) and c) rise followed by further rise (32). There was no serious adverse event leading to drug withdrawal or mortality in the first three months. Conclusions: Prolongation of QTcF occurs in alarming numbers during first two weeks of BDQ therapy as well as shortened QT. However, BDQ was otherwise tolerated well by the real world MDR & XDR-TB patients in short term. Intensive ECG and clinical monitoring is recommended to detect possible serious implications of such ECG changes in the long term.

scholarly journals Ocular adverse events in PD-1 and PD-L1 inhibitors

2021 ◽  
Vol 9 (7) ◽  
pp. e002119
Author(s):  
LeAnne Young ◽  
Shanda Finnigan ◽  
Howard Streicher ◽  
Helen X Chen ◽  
James Murray ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Effects ◽  
Adverse Events ◽  
Anticancer Agents ◽  
Adverse Event Reporting ◽  
Lower Grade ◽  
Serious Adverse Events ◽  
Serious Adverse Event ◽  
Programmed Death ◽  
Depth Analysis

BackgroundProgrammed death-1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors can cause unique immune-related adverse effects due to non-specific immunological activation. However, less is known about adverse effects of these drugs in the eye.MethodsTwo adverse event databases were retrospectively reviewed. The two databases consisted of a routine adverse event database and a serious adverse event database of expeditiously submitted reports. Patients with any malignancy who had ocular adverse events while on PD-1/PD-L1 inhibitor treatment were included. Patients received nivolumab, pembrolizumab, atezolizumab or durvalumab alone or in combination with other anticancer agents per each trial’s protocol. Databases were queried up to May 19, 2020.ResultsIn the routine adverse event database, 272 adverse events from 213 patients were reported and in the serious adverse event reporting database, 59 ocular adverse events from 47 patients were reported. A lower estimate of the prevalance from the routine adverse event database showed 259/7727 patients on study treatment arms reporting ocular adverse events (3.3% prevalence). Excluding trials that do not report lower grade adverse events to the routine adverse event database results in a higher end estimate of 242/3255 patients on study treatment arms reporting ocular adverse events (7.4% prevalence). Ocular events occurred early after drug initiation (routine database: median 6 weeks, IQR 0–16, serious adverse events database: median 11 weeks, IQR 6–21). The median Common Terminology Criteria for Adverse Events grade was grade 1 (mild) (IQR 1–2) and grade 2 (moderate) (IQR 2–3) for the routine database and the serious adverse events database, respectively. In-depth analysis of the serious adverse event reports revealed varying degrees of clinical workup, with 30/47 patients (64%) receiving ophthalmological evaluation and 16/47 (34%) of patients having to delay or discontinue treatment. However, 16/47 (34%) patients experienced resolution and 14/47 (30%) patients experienced at least some improvement.ConclusionsThis is one of the largest analyses of ocular adverse events in patients treated with PD-1/PD-L1 inhibitors in the USA. We found ocular adverse events are rare complications of PD-1/PD-L1 inhibitor therapy, can be severe enough to cause treatment discontinuation/delay, and may not always be appropriately evaluated by eye specialists. Standardized plans for ophthalmology evaluation and management of ocular toxicities are needed in studies of patients treated with PD-1/PD-L1 inhibitors.

scholarly journals Lifetime Risk of Total Hip Replacement Surgery and Temporal Trends in Utilization: A Population-Based Analysis

2014 ◽  
Vol 66 (8) ◽  
pp. 1213-1219 ◽  
Author(s):  
Megan Bohensky ◽  
Ilana Ackerman ◽  
Richard de Steiger ◽  
Alexandra Gorelik ◽  
Caroline Brand
Keyword(s):  
Total Hip Replacement ◽  
Hip Replacement ◽  
Temporal Trends ◽  
Population Based ◽  
Lifetime Risk ◽  
Total Hip ◽  
Replacement Surgery ◽  
Hip Replacement Surgery
Sign in / Sign up

Export Citation Format

Share Document