Does a mandatory non-medical switch from originator to biosimilar infliximab lead to increased use of outpatient healthcare resources? A register-based study in patients with inflammatory arthritis

ObjectivesNational Danish guidelines in May 2015 dictated a mandatory switch from originator infliximab (INX) to biosimilar CT-P13 in patients with inflammatory rheumatic disease. We investigated if this non-medical switch changed use of outpatient hospital resources.MethodsObservational cohort study. Switchers were identified in DANBIO. Rheumatic outpatient contacts, visits and services were identified in the National Patient Registry. The 6-month rate for (1) number of visits (or services) and (2) days with ≥1 visit (or service) were compared before/after switching (paired t-tests). Visits per week per patient before/after the switch date were analysed with graphical interrupted time-series analysis.ResultsIn 769 switchers (372 males, median age 54 years (IQR 44–66)), 1484 outpatient contacts, 6718 visits and 9243 days with services (693 on switch date) were identified. Mean visit rate was 3.89 before and 3.95 after switch (p=0.35). Total number of services was 19 752 (2019 on switch date). Mean rates before/after switch for 16 service categories were small and differences close to zero. Visits per week per patient appeared similar before/after switch with peaks every ≈8 weeks (standard INX infusion interval).ConclusionChanges were marginal with no clinically relevant increase in use of outpatient health care resources 6 months after compared with 6 months before mandatory switch from originator to biosimilar infliximab.

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Incidence of hip and knee replacement in patients with rheumatoid arthritis following the introduction of biological DMARDs: an interrupted time-series analysis using nationwide Danish healthcare registers

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2017-212424 ◽

2017 ◽

Vol 77 (5) ◽

pp. 684-689 ◽

Cited By ~ 27

Author(s):

René Lindholm Cordtz ◽

Samuel Hawley ◽

Daniel Prieto-Alhambra ◽

Pil Højgaard ◽

Kristian Zobbe ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Time Series ◽

Time Series Analysis ◽

Incidence Rate ◽

Interrupted Time Series ◽

Incidence Rates ◽

Interrupted Time Series Analysis ◽

Series Analysis ◽

National Patient ◽

The Impact

ObjectivesTo study the impact of the introduction of biological disease-modifying anti-rheumatic drugs (bDMARDs) and associated rheumatoid arthritis (RA) management guidelines on the incidence of total hip (THR) and knee replacements (TKR) in Denmark.MethodsNationwide register-based cohort and interrupted time-series analysis. Patients with incident RA between 1996 and 2011 were identified in the Danish National Patient Register. Patients with RA were matched on age, sex and municipality with up to 10 general population comparators (GPCs). Standardised 5-year incidence rates of THR and TKR per 1000 person-years were calculated for patients with RA and GPCs in 6-month periods. Levels and trends in the pre-bDMARD (1996–2001) were compared with the bDMARD era (2003–2016) using segmented linear regression interrupted by a 1-year lag period (2002).ResultsWe identified 30 404 patients with incident RA and 297 916 GPCs. In 1996, the incidence rate of THR and TKR was 8.72 and 5.87, respectively, among patients with RA, and 2.89 and 0.42 in GPCs. From 1996 to 2016, the incidence rate of THR decreased among patients with RA, but increased among GPCs. Among patients with RA, the incidence rate of TKR increased from 1996 to 2001, but started to decrease from 2003 and throughout the bDMARD era. The incidence of TKR increased among GPCs from 1996 to 2016.ConclusionWe report that the incidence rate of THR and TKR was 3-fold and 14-fold higher, respectively among patients with RA compared with GPCs in 1996. In patients with RA, introduction of bDMARDs was associated with a decreasing incidence rate of TKR, whereas the incidence of THR had started to decrease before bDMARD introduction.

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The impact of first and second wave of COVID-19 on knee and hip surgeries in Sweden

Journal of Experimental Orthopaedics ◽

10.1186/s40634-021-00382-7 ◽

2021 ◽

Vol 8 (1) ◽

Author(s):

Andrea Dell’Isola ◽

Ali Kiadaliri ◽

Aleksandra Turkiewicz ◽

Velocity Hughes ◽

Karin Magnusson ◽

...

Keyword(s):

Marked Decrease ◽

Interrupted Time Series ◽

Interrupted Time Series Analysis ◽

Southern Sweden ◽

Joint Replacements ◽

Healthcare Data ◽

Hospital Resources ◽

End Stage ◽

The Impact ◽

Second Wave

Abstract Purpose To investigate the impact of COVID-19 in Sweden on rates of knee and hip surgeries. Methods We used healthcare data for the population of the southernmost region in Sweden (1.4 million inhabitants). We did an interrupted time-series analysis to estimate changes in rates and trends of joint replacements (JR), arthroscopies, and fracture surgeries for knee or hip in April–December 2020 compared to pre-COVID-19 levels adjusting for seasonal variations. Results We found a drop of 54% (95% CI 42%; 68%) and 42% (95% CI 32%; 52%), respectively, in the rate of JRs and arthroscopies in April 2020 when compared to the counterfactual scenario. This was followed by an increase that brought the rates of JRs and arthroscopies back to their predicted levels also during the beginning of the second wave (November–December 2020). Acute fracture surgeries were largely unaffected, i.e. did not show any decrease as observed for the other surgeries. Conclusions In southern Sweden, we observed a marked decrease in elective knee and hip surgeries following the first wave of Covid-19. The rates remained close to normal during the beginning of the second wave suggesting that important elective surgeries for patients with end-stage osteoarthritis can still be offered despite an ongoing pandemic provided adequate routines and hospital resources.

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Utility-based outcomes made easy: The number needed per quality-adjusted life year gained. An observational cohort study of tumor necrosis factor blockade in inflammatory arthritis from Southern Sweden

Arthritis Care & Research ◽

10.1002/acr.20235 ◽

2010 ◽

Vol 62 (10) ◽

pp. 1399-1406 ◽

Cited By ~ 17

Author(s):

Anders Gülfe ◽

Lars Erik Kristensen ◽

Tore Saxne ◽

Lennart T. H. Jacobsson ◽

Ingemar F. Petersson ◽

...

Keyword(s):

Cohort Study ◽

Tumor Necrosis Factor ◽

Inflammatory Arthritis ◽

Tumor Necrosis ◽

Quality Adjusted Life Year ◽

Observational Cohort Study ◽

Southern Sweden ◽

Observational Cohort ◽

Necrosis Factor ◽

Quality Adjusted Life

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Interrupted Time Series Analysis of Changes in Zolpidem Use Due to Media Broadcasts

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18105114 ◽

2021 ◽

Vol 18 (10) ◽

pp. 5114

Author(s):

Bo-Ram Yang ◽

Kyu-Nam Heo ◽

Yun Mi Yu ◽

Ga-Bin Yeom ◽

Hye Duck Choi ◽

...

Keyword(s):

Time Series ◽

Time Series Analysis ◽

Suicide Risk ◽

Interrupted Time Series ◽

Prescription Rate ◽

Interrupted Time Series Analysis ◽

Series Analysis ◽

Public Media ◽

Before And After ◽

National Patient

Media has become a major source of information on health and plays a role in the decision-making process on health topics. We aimed to evaluate the association between zolpidem use and media broadcasts that reported the suicide risk. We obtained the data of adult outpatients who have been prescribed zolpidem or other hypnotics from the National Patient Sample database (2015–2017). We evaluated the change in zolpidem or other hypnotic prescription trends based on the prescription rate and average daily prescribed dose before and after July 2016, using interrupted time series analysis. A total of 129,787 adult patients had at least one zolpidem prescription in 3 years. The prescription rate of zolpidem after the broadcast decreased significantly by 0.178% (95% confidence interval (CI): −0.214, −0.142), whereas that of other hypnotic users did not differ from that before the broadcast (−0.020%, 95% CI: −0.088, 0.047). However, the trends in the prescription rate before and after the broadcast did not differ for zolpidem and other hypnotics. Broadcasting medication safety through major public media could have an effect on medication use. After broadcasting about the suicide risk of zolpidem, its overall prescription rate decreased immediately, but the trend was not changed.

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Changes in the trajectory of Long Covid symptoms following COVID-19 vaccination: community-based cohort study

10.1101/2021.12.09.21267516 ◽

2021 ◽

Author(s):

Daniel Ayoubkhani ◽

Charlotte Bermingham ◽

Koen B Pouwels ◽

Myer Glickman ◽

Vahe Nafilyan ◽

...

Keyword(s):

Cohort Study ◽

Adenovirus Vector ◽

Interrupted Time Series ◽

Interrupted Time Series Analysis ◽

Community Based ◽

Individual Level ◽

Vaccine Type ◽

Observational Cohort ◽

The Uk

Objective: To estimate associations between COVID-19 vaccination and Long Covid symptoms in adults who were infected with SARS-CoV-2 prior to vaccination. Design: Observational cohort study using individual-level interrupted time series analysis. Setting: Random sample from the community population of the UK. Participants: 28,356 COVID-19 Infection Survey participants (mean age 46 years, 56% female, 89% white) aged 18 to 69 years who received at least their first vaccination after test-confirmed infection. Main outcome measures: Presence of long Covid symptoms at least 12 weeks after infection over the follow-up period 3 February to 5 September 2021. Results: Median follow-up was 141 days from first vaccination (among all participants) and 67 days from second vaccination (84% of participants). First vaccination was associated with an initial 12.8% decrease (95% confidence interval: -18.6% to -6.6%) in the odds of Long Covid, but increasing by 0.3% (-0.6% to +1.2%) per week after the first dose. Second vaccination was associated with an 8.8% decrease (-14.1% to -3.1%) in the odds of Long Covid, with the odds subsequently decreasing by 0.8% (-1.2% to -0.4%) per week. There was no statistical evidence of heterogeneity in associations between vaccination and Long Covid by socio-demographic characteristics, health status, whether hospitalised with acute COVID-19, vaccine type (adenovirus vector or mRNA), or duration from infection to vaccination. Conclusions: The likelihood of Long Covid symptoms reduced after COVID-19 vaccination, and the improvement was sustained over the follow-up period after the second dose. Vaccination may contribute to a reduction in the population health burden of Long Covid, though longer follow-up time is needed.

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Effect of COVID-19 lockdown on hospital admissions and mortality in rural KwaZulu-Natal, South Africa: interrupted time series analysis

BMJ Open ◽

10.1136/bmjopen-2020-047961 ◽

2021 ◽

Vol 11 (3) ◽

pp. e047961 ◽

Cited By ~ 1

Author(s):

Amy McIntosh ◽

Max Bachmann ◽

Mark J Siedner ◽

Dickman Gareta ◽

Janet Seeley ◽

...

Keyword(s):

South Africa ◽

Time Series ◽

Hospital Admissions ◽

Interrupted Time Series ◽

Interrupted Time Series Analysis ◽

Time Series Regression ◽

Content Type ◽

Kwazulu Natal ◽

Level 3 ◽

Observational Cohort

ObjectiveTo assess the effect of lockdown during the 2020 COVID-19 pandemic on daily all-cause admissions, and by age and diagnosis subgroups, and the odds of all-cause mortality in a hospital in rural KwaZulu-Natal (KZN).DesignObservational cohort.SettingReferral hospital for 17 primary care clinics in uMkhanyakude District.ParticipantsData collected by the Africa Health Research Institute on all admissions from 1 January to 20 October: 5848 patients contributed to 6173 admissions.ExposureFive levels of national lockdown in South Africa from 27 March 2020, with restrictions decreasing from levels 5 to 1, respectively.Outcome measuresChanges and trends in daily all-cause admissions and risk of in-hospital mortality before and at each stage of lockdown, estimated by Poisson and logistic interrupted time series regression, with stratification for age, sex and diagnosis.ResultsDaily admissions decreased during level 5 lockdown for infants (incidence rate ratio (IRR) compared with prelockdown 0.63, 95% CI 0.44 to 0.90), children aged 1–5 years old (IRR 0.43, 95% CI 028 to 0.65) and respiratory diagnoses (IRR 0.57, 95% CI 0.36 to 0.90). From level 4 to level 3, total admissions increased (IRR 1.17, 95% CI 1.06 to 1.28), as well as for men >19 years (IRR 1.50, 95% CI 1.17 to 1.92) and respiratory diagnoses (IRR 4.26, 95% CI 2.36 to 7.70). Among patients admitted to hospital, the odds of death decreased during level 5 compared with prelockdown (adjusted OR 0.48, 95% CI 0.28 to 0.83) and then increased in later stages.ConclusionsLevel 5 lockdown is likely to have prevented the most vulnerable population, children under 5 years and those more severely ill from accessing hospital care in rural KZN, as reflected by the drop in admissions and odds of mortality. Subsequent increases in admissions and in odds of death in the hospital could be due to improved and delayed access to hospital as restrictions were eased.

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Acute complications in the post-anaesthesia care unit after infrainguinal surgery for lower limb ischaemia – a prospective observational cohort study

VASA ◽

10.1024/0301-1526/a000745 ◽

2019 ◽

Vol 48 (1) ◽

pp. 89-97

Author(s):

Karin Yeung ◽

Jonas Peter Eiberg ◽

Henrik Kehlet ◽

Eske Kvanner Aasvang

Keyword(s):

Lower Limb ◽

Severe Pain ◽

Observational Cohort Study ◽

Limb Ischaemia ◽

Post Anaesthesia Care Unit ◽

Lower Limb Ischaemia ◽

Acute Complications ◽

Observational Cohort ◽

Anaesthesia Care ◽

Pacu Stay

Abstract. Background: Arterial surgery for lower limb ischaemia is a frequently performed procedure in patients with severe cardio-pulmonary comorbidities, making them high-risk patients for acute postoperative complications with a need for prolonged stay in the post-anaesthesia care unit (PACU). However, detailed information on complications during the PACU stay is limited, hindering mechanism-based interventions for early enhanced recovery. Thus, we aimed to systematically describe acute complications and related risk factors in the immediate postoperative phase after infrainguinal arterial surgery. Patients and methods: Patients transferred to the PACU after infrainguinal arterial surgery due to chronic or acute lower limb ischaemia were consecutively included in a six-month observational cohort study. Pre- and intraoperative data included comorbidities as well as surgical and anaesthetic technique. Data on complications and treatments in the PACU were collected every 15 minutes using a standardised assessment tool. The primary endpoint was occurrence of predefined moderate or severe complications occurring during PACU stay. Results: In total, 155 patients were included for analysis. Eighty (52 %) patients experienced episodes with oxygen desaturation (< 85 %) and moderate or severe pain occurred in 72 patients (47 %); however, circulatory complications (hypotension, tachycardia) were rare. Preoperative opioid use was a significant risk factor for moderate or severe pain in PACU (59 vs. 38 % chronic vs. opioid naïve patients (P = 0.01). Conclusions: Complications in the PACU after infrainguinal arterial surgery relates to saturation and pain, suggesting that future efforts should focus on anaesthesia and analgesic techniques including opioid sparing regimes to enhance early postoperative recovery.

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