scholarly journals Multidisciplinary team intervention to reduce the nocebo effect when switching from the originator infliximab to a biosimilar

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001396
Author(s):  
Juliette Petit ◽  
Marie Antignac ◽  
Rose-Marie Poilverd ◽  
Régine Baratto ◽  
Sylvie Darthout ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Healthcare Professionals ◽  
Musculoskeletal Diseases ◽  
Retention Rate ◽  
Nocebo Effect ◽  
Historical Cohort ◽  
Tailored Communication ◽  
Secondary Outcomes ◽  
Patient Representative

ObjectivesTo evaluate an intervention to reduce the nocebo effect (NE) when switching from the originator infliximab (OI) to the infliximab biosimilar SB2 in chronic inflammatory rheumatic disease (CIRD).MethodsAn intervention was built with healthcare professionals (HPs) and a patient representative, based on a systematic review of interventions reducing the NE in musculoskeletal diseases and semi-directed questioning of five patients. Our strategy consisted of training HPs, switch information given by the nurses, a consistent vocabulary. All CIRD patients switched from OI to SB2 were included for the intervention. The primary outcome was the SB2 retention rate (RR) at 34 weeks. Secondary outcomes were the SB2 RR at 12 months, discontinuation rates due to a possible NE and comparison with a historical cohort of CIRD patients receiving the OI and 6 published European cohorts.Results45 patients were included from March 2018 (rheumatoid arthritis, n=17, spondylarthritis, n=28). After 34 weeks, the SB2 RR was 91.2%, similar to the historical cohort RR (p=0.41) but higher than the 3 European cohort RRs (p<0.05). At 12 months, the SB2 RR was 84.5% vs 88.4% for the historical cohort (p=0.52). SB2 discontinuation due to a possible NE was 6.6% after 12 months.ConclusionsA tailored communication with a prominent role of nurses reduced the NE in non-medical switches from the OI to SB2 as compared to published results. The RR was similar to the historical cohort RR. The methodology used to construct this intervention may help improve the outcomes of switches with upcoming biosimilars.

scholarly journals FRI0630-HPR ONE-YEAR FOLLOW-UP OF A NURSE-LED TEAM INTERVENTION EFFECTIVE IN REDUCING THE NOCEBO EFFECT WHEN SWITCHING FROM ORIGINATOR INFLIXIMAB TO A BIOSIMILAR.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 919.2-920
Author(s):  
J. Petit ◽  
M. Antignac ◽  
K. Louati ◽  
S. Desouches ◽  
N. Deparis ◽  
...  
Keyword(s):  
Retention Rate ◽  
Inflammatory Rheumatic Diseases ◽  
Nocebo Effect ◽  
Survival Curves ◽  
Short Term ◽  
Historical Cohort ◽  
One Year ◽  
Mean Time

Background:Nonspecific subjective adverse effects and symptoms (NSAE/NSS), usually considered as related to a nocebo effect (NE), have been identified as a barrier to the acceptability of switches from biologic originators (BO) to biosimilars (BS) in rheumatology. A multidisciplinary team intervention with a prominent role of nurses has provided a reduction of the NE assessed in the short-term during a systematic switch from originator Infliximab (OI) to the biosimilar infliximab SB2 (ref.1).Objectives:To assess the intervention outcomes after one-year follow up in comparison with a historical cohort.Methods:The intervention was developed after a literature search and semi-directive interviews of patients, and included consensual communication towards patients, with a prominent role of nurses (Ref.1). All patients with chronic inflammatory rheumatic diseases (CIRD) treated by OI were included and followed-up in routine care. The outcomes were I) SB2 retention rate (RR) II) SB2 discontinuation rate due to a presumed NE, defined as lack of efficacy with no objective criteria for increased inflammation or non-objective and non-specific adverse event, either occurring after the switch and disappearing after back-switch or change of biologic. Criteria for NSAE/NSS in the historical cohort were the same lack of efficacy or subjective adverse events and disappearance after change of biologic BD. Medium-term (12 months) SB2 outcomes were assessed and compared with I) the data obtained in the short-term (34 weeks) II) the data from an historical cohort of CIRD patients treated by OI in the same rheumatology department, using Kaplan-Meier survival curve.Results:Forty-five patients were prospectively included for the switch from March 2018 to August 2018: 17 with rheumatoid arthritis (RA), 28 with spondylarthritis (SpA); 55% were women, mean age was 53.2 (SD: 2,1), and mean time under OI was 113.5 (SD9.3). For the historical cohort, the 52 patients treated with OI between December 2016 and January 2017 were included and their data collected at baseline and one year. Fifty-nine percent were women, mean age at inclusion was 50.25 (1.2), and mean time under OI was 94.8 (9.4).SB2 RR did not differ from the OI RR in the historical cohort: 91.2% and 96.2% respectively at 34 weeks (p = 0.41); 84.4% and 88.5% respectively at 12 months (p = 0.52) (figure 1). The SB2 RR was significantly higher than in three other European cohorts at 34 weeks (mean RR 73.6%, p<0.05, ref.1) but not at 12 months (mean RR 80.9%, ref.2,3,4).SB2 and OI discontinuations due to NSAE/NSS at 34 weeks were 2,2 % and 1.9% respectively; at 12 months 6,6% and 1.9% respectively (p= 0.6).Conclusion:An intervention based on a tailored communication with a prominent role of nurses was effective in reducing the NE when switching from OI to SB2 in the short term, compared with an historical cohort and other European cohorts. The one-year follow-up showed no statistical difference in RR or NE compared with our historical cohort. The present study shows that appropriate interventions may be developed to improve the outcome of switches to biosimilars.Figure 1:Treatment withdrawal free survival curves (SB2 in switched cohort and OI in historical cohort).Kaplan Meir survival curves. Comparison with Log-Rank test between OI to SB2 cohort and historical OI cohort, p = 0.520. OI : original infliximab.References:[1] Petit J. Ann Rheum Dis, volume 78, supplement 2, year 2019, page A1447[2] Glintborg B. et al. Ann Rheum Dis 2017;76:1426–31.[3] Nikiphorou E. et al. Expert Opin Biol Ther 2015;15:1677–83.[4] Boone NW. et al. Eur J Clin Pharmacol 2018;:1–7.Acknowledgments:Dr Margaux Boisson Service de rhumatologie du Professeur Kahan, Hôpital Cochin, APHP.Disclosure of Interests:Juliette Petit: None declared, Marie Antignac: None declared, Karine Louati: None declared, Sandra Desouches: None declared, Nathalie DEPARIS: None declared, Regine Baratto: None declared, Rosemarie POILVERD: None declared, Sylvie Dartout: None declared, Francis Berenbaum Grant/research support from: TRB Chemedica (through institution), MSD (through institution), Pfizer (through institution), Consultant of: Novartis, MSD, Pfizer, Lilly, UCB, Abbvie, Roche, Servier, Sanofi-Aventis, Flexion Therapeutics, Expanscience, GSK, Biogen, Nordic, Sandoz, Regeneron, Gilead, Bone Therapeutics, Regulaxis, Peptinov, 4P Pharma, Paid instructor for: Sandoz, Speakers bureau: Novartis, MSD, Pfizer, Lilly, UCB, Abbvie, Roche, Servier, Sanofi-Aventis, Flexion Therapeutics, Expanscience, GSK, Biogen, Nordic, Sandoz, Regeneron, Gilead, Sandoz, Catherine Beauvais Speakers bureau: Abbvie, MSD, Roche, UCB, Mylan, Sanofi

PaRamEDIc assessment of laCTate in OHCA and survival to hospital (PREDICT protocol)

2021 ◽  
Vol 13 (3) ◽  
pp. 100-104
Author(s):  
Karl Charlton ◽  
Hayley Moore
Keyword(s):  
Cardiac Arrest ◽  
Primary Outcome ◽  
Spontaneous Circulation ◽  
Prognostic Role ◽  
Single Centre ◽  
Intravenous Access ◽  
Secondary Outcomes ◽  
Cardiac Arrest Survival ◽  
Hospital Cardiac Arrest

Background: Studies suggest that blood lactate differs between survivors and non-survivors of out-of-hospital cardiac arrest who are transported to hospital. The prognostic role of lactate taken during out-of-hospital cardiac arrest remains unexplored. Aims: To measure the association between lactate taken during out-of-hospital cardiac arrest, survival to hospital and 30-day mortality. Methods: This is a feasibility, single-centre, prospective cohort study. Eligible for inclusion are patients aged ≥18 years suffering out-of-hospital cardiac arrest, receiving cardiopulmonary resuscitation, in the catchment of Newcastle or Gateshead hospitals, who are attended to by a study-trained specialist paramedic. Exclusions are known/apparent pregnancy, blunt or penetrating injury as primary cause of out-of-hospital cardiac arrest and an absence of intravenous access. Between February 2020 and March 2021, 100 participants will be enrolled. Primary outcome is survival to hospital; secondary outcomes are return of spontaneous circulation at any time and 30-day mortality.

Getting It Wrong Most of The Time: Comparing Trialists’ Choice of Primary Outcome With What Patients And Health Professionals Want

2021 ◽  
Author(s):  
Shaun Treweek ◽  
Viviane Miyakoda ◽  
Dylan Burke ◽  
Frances Shiely
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Health Care Professionals ◽  
Primary Outcome ◽  
Healthcare Professionals ◽  
Breast Cancer Patients ◽  
Additional Information ◽  
Cancer Management ◽  
Breast Cancer Management ◽  
Secondary Outcomes

Abstract Background: Randomised trials support improved decision-making through the data they collect. One important piece of data is the primary outcome – so called because it is what the investigators decide is the most important. Secondary outcomes provide additional information to support decision-making. We were interested in knowing how important patients and healthcare professionals consider the outcomes (especially the primary outcome) measured in a selection of published trials. Methods: The work had three stages: 1. We identified a body of late-stage trials in two clinical areas, breast cancer management and nephrology. 2. We identified the primary and secondary outcomes for these trials. 3. We randomly ordered these outcomes and presented them to patients and healthcare professionals (with experience of the clinical area), and we asked them to rank the importance of the outcomes. They were not told which outcomes trial authors considered primary and secondary. Results: In our sample of 44 trials with 46 primary outcomes, 29 patients, one patient representative and 12 healthcare professionals together ranked the primary outcome as the most important outcome 13/46 times, or 30%. Breast cancer patients and health care professionals considered the primary outcome to be the most important outcome for 8/21 primary outcomes chosen by trialists. For nephrology, the equivalent figure was 5/25. The primary outcome appeared in a respondent’s top 5 ranked outcomes 151/178 (85%) times for breast cancer and 225/259 (87%) times for nephrology even if the primary wasn’t considered the most important outcome. Conclusions: The primary outcome in a trial is the most important piece of data collected. It is used to determine how many participants are required, and it is the main piece of information used to judge whether the intervention is effective or not. Our study found that in the view of patients and healthcare professionals, teams doing trials in breast cancer management and nephrology got their choice of primary outcome wrong 70% of the time.

Role of Breathing Exercises and Yoga/Pranayama in Childhood Asthma: A Systematic Review

2019 ◽  
Vol 15 (3) ◽  
pp. 175-183 ◽  
Author(s):  
Rashmi Ranjan Das ◽  
Jhuma Sankar ◽  
Sushil Kumar Kabra
Keyword(s):  
Lung Function ◽  
Adverse Events ◽  
Outcome Measures ◽  
Childhood Asthma ◽  
Primary Outcome ◽  
Immunological Parameters ◽  
Breathing Exercise ◽  
Breathing Exercises ◽  
Secondary Outcomes

Background: arious complementary or alternative medicines (including breathing exercises and yoga/pranayama) have been tried as an attractive option to pharmacotherapy in childhood asthma. Objective: To evaluate the role of breathing exercise and yoga/pranayama as add on therapy to the “pharmacologically recommended treatment” of childhood asthma. Methods: We searched the published literature in the major databases: Medline via Ovid, PubMed, CENTRAL, Embase, and Google Scholar till June 2018. Randomized trials comparing breathing exercises and yoga/ pranayama versus control or as part of a composite intervention versus control were included. The primary outcome measures were quality of life and change in asthma symptoms. Secondary outcomes were: decrease in medication use, number of exacerbations, change in lung function and immunological parameters, school absenteeism and adverse events. Results: A total of 10 trials (466 children, 6-14 years age) were included. The severity of asthma varied among the trials. The data for primary outcome measures could not be pooled, there were mixed results for both primary and secondary outcomes. No significant benefit was obtained in acute asthma and the lung function tests [except PEFR % at 4-6 weeks, PEF absolute at 3 months, and FVC absolute at 3 months] in chronic asthma. One trial compared breathing exercise versus yoga and found no difference. Adverse events were not significant. Conclusion: Breathing exercise and yoga/ pranayama may have some additive role in the treatment of childhood asthma. However, at present, it cannot be recommended as a standard of care due to insufficient data.

scholarly journals Tepid sponging plus dipyrone versus dipyrone alone for reducing body temperature in febrile children

2008 ◽  
Vol 126 (2) ◽  
pp. 107-111 ◽  
Author(s):  
João Guilherme Bezerra Alves ◽  
Natália Dornelas Câmara Marques de Almeida ◽  
Camila Dornelas Câmara Marques de Almeida
Keyword(s):  
Clinical Trial ◽  
Body Temperature ◽  
Randomized Clinical Trial ◽  
Primary Outcome ◽  
Control Group ◽  
Emergency Ward ◽  
Axillary Temperature ◽  
Secondary Outcomes ◽  
To Receive

CONTEXT AND OBJECTIVE: The role of tepid sponging to promote fever control in children is controversial. We did not find any studies reporting on the effectiveness of tepid sponging in addition to dipyrone. The aim of this study was to compare the effects of tepid sponging plus dipyrone with dipyrone alone for reducing fever. DESIGN AND SETTING: A randomized clinical trial was undertaken at Instituto Materno-Infantil Professor Fernando Figueira, Recife, Pernambuco. METHODS: Children from six months to five years old with axillary temperature greater than 38 ºC in the emergency ward between January and July 2006 were eligible. One hundred and twenty children were randomly assigned to receive oral dipyrone (20 mg/kg) or oral dipyrone and tepid sponging for 15 minutes. The primary outcome was mean temperature reduction after 15, 30, 60, 90 and 120 minutes. Secondary outcomes were crying and irritability. RESULTS: 106 children finished the study. After the first 15 minutes, the fall in axillary temperature was significantly greater in the sponged group than in the control group (p < 0.001). From 30 to 120 minutes, better fever control was observed in the control group. Crying and irritability were observed respectively in 52% and 36% of the sponged children and in none and only two of the controls. CONCLUSIONS: Tepid sponging plus dipyrone cooled faster during the first 15 minutes, but dipyrone alone presented better fever control over the two-hour period. Tepid sponging caused mild discomfort, crying and irritability for most of the children.

scholarly journals EULAR Points to Consider for the use of imaging to guide interventional procedures in patients with rheumatic and musculoskeletal diseases (RMDs)

2021 ◽  
pp. annrheumdis-2021-221261
Author(s):  
Christian Dejaco ◽  
Pedro M Machado ◽  
Francesco Carubbi ◽  
Philipp Bosch ◽  
Lene Terslev ◽  
...  
Keyword(s):  
Interventional Procedures ◽  
Healthcare Professionals ◽  
Musculoskeletal Diseases ◽  
Task Force ◽  
Fusion Imaging ◽  
Imaging Modalities ◽  
Imaging Method ◽  
Sacroiliac Joints ◽  
Level Of Agreement

ObjectivesTo develop evidence-based Points to Consider (PtC) for the use of imaging modalities to guide interventional procedures in patients with rheumatic and musculoskeletal diseases (RMDs).MethodsEuropean Alliance of Associations for Rheumatology (EULAR) standardised operating procedures were followed. A systematic literature review was conducted to retrieve data on the role of imaging modalities including ultrasound (US), fluoroscopy, MRI, CT and fusion imaging to guide interventional procedures. Based on evidence and expert opinion, the task force (25 participants consisting of physicians, healthcare professionals and patients from 11 countries) developed PtC, with consensus obtained through voting. The final level of agreement was provided anonymously.ResultsA total of three overarching principles and six specific PtC were formulated. The task force recommends preference of imaging over palpation to guide targeted interventional procedures at peripheral joints, periarticular musculoskeletal structures, nerves and the spine. While US is the favoured imaging technique for peripheral joints and nerves, the choice of the imaging method for the spine and sacroiliac joints has to be individualised according to the target, procedure, expertise, availability and radiation exposure. All imaging guided interventions should be performed by a trained specialist using appropriate operational procedures, settings and assistance by technical personnel.ConclusionThese are the first EULAR PtC to provide guidance on the role of imaging to guide interventional procedures in patients with RMDs.

scholarly journals Can a Glove-Coach Technology Significantly Increase the Efficacy of Cardiopulmonary Resuscitation on Non-healthcare Professionals? A Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Michele Musiari ◽  
Andrea Saporito ◽  
Samuele Ceruti ◽  
Maira Biggiogero ◽  
Martina Iattoni ◽  
...  
Keyword(s):  
Cardiopulmonary Resuscitation ◽  
Primary Outcome ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Control Group ◽  
Chest Compressions ◽  
Compression Depth ◽  
The Mean ◽  
Secondary Outcomes ◽  
Single Blind

Introduction: Cardiovascular accidents are the world's leading cause of death. A good quality cardiopulmonary resuscitation (CPR) can reduce cardiac arrest-associated mortality. This study aims to test the coaching system of a wearable glove, providing instructions during out-of-hospital CPR.Materials and Methods: We performed a single-blind, controlled trial to test non-healthcare professionals during a simulated CPR performed on an electronic mannequin. The no-glove group was the control. The primary outcome was to compare the accuracy of depth and frequency of two simulated CPR sessions. Secondary outcomes were to compare the decay of CPR performance and the percentage of the duration of accurate CPR.Results: About 130 volunteers were allocated to 1:1 ratio in both groups; mean age was 36 ± 15 years (min–max 21–64) and 62 (48%) were men; 600 chest compressions were performed, and 571 chest compressions were analyzed. The mean frequency in the glove group was 117.67 vs. 103.02 rpm in the control group (p &lt; 0.001). The appropriate rate cycle was 92.4% in the glove group vs. 71% in the control group, with a difference of 21.4% (p &lt; 0.001). Mean compression depth in the glove group was 52.11 vs. 55.17 mm in the control group (p &lt; 0.001). A mean reduction of compression depth over time of 5.3 mm/min was observed in the control group vs. 0.83 mm/min of reduction in the glove group.Conclusion: Visual and acoustic feedbacks provided through the utilization of the glove's coaching system were useful for non-healthcare professionals' CPR performance.

scholarly journals One-year results after transitioning from etanercept originator to biosimilar in a setting promoting shared decision-making in rheumatology

2020 ◽  
Vol 4 (2) ◽  
Author(s):  
Wieland D Müskens ◽  
Sanne A A Rongen-van Dartel ◽  
Steven Teerenstra ◽  
Eddy M M Adang ◽  
Piet L C M van Riel
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
Retention Rate ◽  
Subjective Health ◽  
Retention Rates ◽  
Health Complaints ◽  
Shared Decision ◽  
Subjective Health Complaints ◽  
Nocebo Effect ◽  
Historical Cohort

Abstract Objective The aim was to study the effect of non-mandatory transitioning from etanercept originator to etanercept biosimilar on retention rates in a setting promoting shared decision-making. Methods In 2016, all patients treated with etanercept originator and stable disease at the Rheumatology department in Bernhoven were offered transitioning to etanercept biosimilar by an opt-in approach. A historical cohort of patients treated with etanercept originator in 2015 was identified as the control group. Etanercept discontinuation was compared between the cohorts using Cox regression. To study the nocebo effect, reasons for discontinuation were categorized into objective reasons (e.g. laboratory abnormalities, increase in swollen joint count, allergic reaction) and subjective health complaints (symptoms perceptible only to the patient, e.g. tiredness, arthralgia). An adjusted Kaplan–Meier curve for retention of the etanercept biosimilar was made, censoring subjective health complaints as the reason for discontinuation. Results Seventy of the 79 patients eligible for transitioning agreed to transition (89%). The 1-year crude retention rate of etanercept in the transition cohort was 73% (95% CI: 0.62, 0.83), compared with a retention rate of 89% (95% CI: 0.81, 0.95) in the historical cohort (P = 0.013). This resulted in a higher risk of treatment discontinuation in the transition cohort (adjusted hazard ratio = 2.73; 95% CI: 1.23, 6.05, P = 0.01). After adjusting for the nocebo effect, the cohorts had comparable retention rates (86 vs 89%, P = 0.51). Conclusion Non-mandatory transition from etanercept originator to its biosimilar using an opt-in approach in a setting promoting shared decision-making resulted in a higher discontinuation of etanercept compared with the historical cohort. This could be attributed largely to the nocebo effect.

Images of the Hospice

2017 ◽  
Author(s):  
Alan Baron ◽  
John Hassard ◽  
Fiona Cheetham ◽  
Sudi Sharifi
Keyword(s):  
General Public ◽  
Palliative Medicine ◽  
Healthcare Professionals ◽  
Hospice Care ◽  
Care Work ◽  
Dirty Work ◽  
Key Stakeholders ◽  
Host Organization ◽  
Local Healthcare

This chapter looks ‘outside’ the Hospice at issues of the organization’s image. The authors talked to staff, volunteers, and members of the general public, as well as to a number of key stakeholders in the local healthcare community, in order to gauge their views on the host organization. The analysis examines the problems associated with the image of hospices and discusses attempts of staff and volunteers to ‘dispel the myths’ about the nature of hospice care work—a form of labour which potentially runs the risk of being characterized as ‘dirty work’. The chapter then examines how the Hospice is seen in the eyes of other healthcare professionals and discusses the choice of palliative medicine as a career for junior medics. Finally it discusses a degree of ‘confusion’ that staff and volunteers claim exists in the minds of GPs and consultants in specialist cancer hospitals about the role of hospices.

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