scholarly journals Equity in Vaccine Trials for Higher Weight People? A Rapid Review of Weight-Related Inclusion and Exclusion Criteria for COVID-19 Clinical Trials

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1466
Author(s):  
Jessica Campbell ◽  
Juliet Sutherland ◽  
Danielle Bucknall ◽  
Lily O’Hara ◽  
Anita Heywood ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Weight Status ◽  
Health Inequities ◽  
Phase Iii ◽  
Rapid Review ◽  
Exclusion Criterion ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Vaccine Trials ◽  
Trial Protocols

Higher weight status, defined as body mass index (BMI) ≥ 30 kg/m2, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine trials should be representative of the weight spectrum across the global population. Appropriate subgroup analysis should be conducted to ensure equitable vaccine outcomes for higher weight people. In this study, inclusion and exclusion criteria of registered clinical trial protocols were reviewed to determine the proportion of trials including higher weight people, and the proportion of trials conducting subgroup analyses of efficacy by BMI. Eligibility criteria of 249 trial protocols (phase I, II, III and IV) were analysed; 51 protocols (20.5%) specified inclusion of BMI > 30, 73 (29.3%) specified exclusion of BMI > 30, and 125 (50.2%) did not specify whether BMI was an inclusion or exclusion criterion, or if BMI was included in any ‘health’ screenings or physical examinations during recruitment. Of the 58 protocols for trials in phase III and IV, only 2 (3.4%) indicated an intention to report subgroup analysis of vaccine efficacy by weight status. Higher weight people appear to be significantly under-represented in the majority of vaccine trials. This may result in reduced efficacy and acceptance of COVID-19 vaccines for higher weight people and exacerbation of health inequities within this population group. Explicit inclusion of higher weight people in COVID-19 vaccine trials is required to reduce health inequities.

scholarly journals Equity in vaccine trials for higher weight people? Protocol for a rapid review of inclusion and exclusion criteria for higher weight people in clinical trials for COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e050114
Author(s):  
Jessica Campbell ◽  
Matthew Hobbs ◽  
Lily O’Hara ◽  
Angela Ballantyne ◽  
Anita Heywood ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Weight Status ◽  
Vaccine Trial ◽  
Risk Of Bias ◽  
Rapid Review ◽  
Vaccine Platform ◽  
Exclusion Criteria ◽  
Vaccine Trials ◽  
Increased Risk ◽  
Trial Protocols

IntroductionVaccination is a public health strategy that aims to reduce the burden of viral illness, especially important for populations known or likely to be at increased risk for inequitable outcomes due to the disease itself or disparities in care accessed and received. The role of weight status in COVID-19 susceptibility and disease burden remains unclear. Despite this, higher weight is frequently described as a definitive risk factor for both susceptibility and disease severity. Therefore, COVID-19 vaccine trials should recruit a study group representative of the full weight spectrum, and undertake appropriate subgroup analysis by weight status to evaluate response and titrate dose regimes where indicated to ensure equitable outcomes for higher weight people.Methods and analysisWe aim to review inclusion and exclusion criteria of clinical trial protocols registered with ClinicalTrials.gov, ISRCTN Register, the WHO official vaccine trial register, and ‘The COVID-19 Vaccine Tracker’. To determine the number of trials including higher weight (body mass index >30 kg/m2) individuals and the number of trials conducting efficacy subgroup analyses by weight status. Screening, data extraction and quality appraisal of trial protocols will be completed independently by a minimum of two reviewers. Clinical trials will be assessed for risk of bias using the Risk of Bias-2 tool. We will conduct a descriptive analysis of extracted data. The following subsets are proposed: participation of higher weight people in COVID-19 vaccine trials by trial phase, country and vaccine platform.Ethics and disseminationEthical approval was not required for this review. The results of this rapid review will be presented at appropriate conferences and published in a suitable peer reviewed journal.PROSPERO registration numberCRD42020226573

Eligibility Criteria Are Not Associated with Expected or Observed Adverse Events in Randomized Controlled Trials (RCTs) of Hematologic Malignancies

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 635-635
Author(s):  
Abby Statler ◽  
Tomas Radivoyevitch ◽  
Caitlin Siebenaller ◽  
Aaron T. Gerds ◽  
Matt Kalaycio ◽  
...  
Keyword(s):  
Adverse Events ◽  
Board Of Directors ◽  
Hematologic Malignancies ◽  
Phase Iii ◽  
Organ Function ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Advisory Committees ◽  
Randomized Controlled ◽  
Drug Classes

Abstract Background: RCTs play a key role in advancing treatment for hematologic malignancies and are often a requisite for regulatory approval. To maximize this potential for registration, eligibility criteria for RCTs may be overly restrictive so as to avoid toxicities that may be attributed to the study drug. We hypothesized that RCTs in hematologic malignancies exclude patients (pts) irrespective of adverse events (AEs) that would be expected based on drug class, or that are ultimately observed. Methods: We searchedjournals with an impact factor ≥5 for therapeutic phase II and III hematologic malignancy RCTs in adults published from 01/10 to 01/15. Trial eligibility criteria were extracted from clinicaltrials.gov, the International Standard Randomized Controlled Trial Number (ISRCTN) registry, or the protocol, when available. AEs were collected from package inserts or published manuscripts for the following drug classes: alkylators, antimetabolites, anthracyclines, topoisomerase inhibitors, microtubule inhibitors, proteasome inhibitors, and monoclonal antibodies. Toxicities of these drug classes were compared to corresponding trial exclusion criteria using the exact binomial test. We examined reported AEs occurring in ≥10% of subjects within trials, the threshold applied in medication labels. Poisson distributions, with means = 10% of sample sizes of studies (with exclusion criteria), were assumed in calculating the binomial probability for each AE; we considered AEs relevant to the most commonly used organ function exclusion criteria: hepatic, kidney, cardiac, and neurological. Results: Of 252 full publications identified, 91 (36%) were not RCTs; 27 (11%) were pediatric; 23 (9%) did not meet other inclusion criteria, and 13 (5%) were "kin" publications of the same trial, leaving 98 trials in the final analysis. Of these, 32 (33%) were leukemia trials, 27 (28%) were lymphoma, 34 (35%) were multiple myeloma, and 5 (5%) were myelodysplastic syndromes or myelofibrosis. The majority of studies were phase III (n=77, 79%), multi-center (n=92, 94%), and/or multi-national (n=63, 64%). Of the 98 trials, 12 (12%) contributed pivotal registration data leading to a label change or new approval for 8 drugs. Key trial exclusion criteria were medical comorbidities (e.g. active or prior cancer, previous cardiac conditions, HIV infection, hepatitis, or psychiatric disease, in 97% of studies); inadequate organ function (in 89%), and poor performance status (in 67%). Exclusion criteria relevant to baseline organ function did not reflect established safety profiles, as the proportion of studies excluding pts with specific organ dysfunction was significantly greater than the proportion of drug classes with known hepatic (85/98 [87%] vs. 75%; P=.007), cardiac (73/98 [74.5%] vs. 62.5%; P=.02), and renal (72/98 [73.5%] vs. 50%; P<.0001) toxicities. Conversely, the proportion of studies excluding patients with neurological deficits was lower than the proportion of drug classes with known neurological toxicities (22/98 [22%] vs. 50%; P<.0001). Similarly, the number of studies that reported ≥10% patients with a ≥grade 1 toxicity was considerably lower than the number of studies expected, assuming study treatments lead to an AE in 10% of pts (Figure): 19 (22%) vs. 41 (48%) of 85 studies for hepatic AEs (P<.0001); 23 (32%) vs. 35 (48%) of 73 studies for cardiac AEs (P=.003), and 4 (6%) vs. 35 (49%) of 72 studies for renal AEs (P <.0001). Of the 22 studies that excluded pts with peripheral neuropathy, 14 (64%) reported ≥10% of pts with this toxicity, vs. the 11 (50%) expected (P=.95). Conclusions: The proportion ofRCTs in hematologic malignancies published in high impact medical journals excluding pts with comorbidities and/or organ function abnormalities does not reflect the expected or observed AEs in these patients. This suggests that landmark RCTs, with an eye to registration, may be overly conservative in using restrictive exclusion criteria. The widespread use of these criteria, many of which may not be appropriate given the toxicity profile of the investigational product, may lead to the systematic exclusion of specific patient populations, limiting trial result generalizability. Disclosures Kodish: Biogen Idec: Consultancy. Sekeres:Celgene Corporation: Membership on an entity's Board of Directors or advisory committees; TetraLogic: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees.

119 A Descriptive Epidemiological Study of Clinical Trials, Comparing Trials Targeted At Older People to Adults of All Ages

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
J P Renton ◽  
D McAllister
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Adverse Events ◽  
Older People ◽  
Exclusion Criterion ◽  
Trial Participation ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Serious Adverse Events ◽  
Icd 10

Abstract Introduction Fewer clinical trials are carried out in older people. It is unclear how representative and applicable clinical trials carried out exclusively in older people are. We compared clinical trials recruiting older people exclusively “older trials” to those recruiting adults of all ages “all age trials”, using anti-hypertensives acting on the renin-angiotensin aldosterone system (RAAS drugs) as an exemplar. Method We searched the US clinical trials register 1, to identify all trials carried out exclusively in those aged over 60. From these we selected trials of RAAS drugs. These were matched in a 2:1 ratio to trials carried out in adults of all ages. Data regarding baseline characteristics, adverse events and eligibility criteria were collected from clinical trial reports and clinicaltrials.gov. Estimated associations were calculated for age, sex and adverse events. Eligibility criteria were described and ICD- 10 coded, as appropriate. Results 71 clinical trials were carried out exclusively in older people.13 related to RAAS drugs. Participants in “Older trials” had higher mean age (73.1 and 55.9 respectively), mean difference 16.17 (CI 15.31–17.02). Older trials had fewer male participants. Participants in older trials had lower mean body mass index (BMI). A higher rate of participants in older trials experienced serious adverse events. (2.07, CI 1.55–2.75.) Few older trials had upper age limits (23.1% V 27% all age trials). All trials had exclusion criteria in multiple ICD blocks. Concurrent medications were a more common exclusion criterion in older trials (61.5% v 40.9%). Conclusions Clinical trials carried out exclusively in older people are representative in terms of age, serious adverse events and eligibility. Although there are multiple exclusion criteria for clinical trial participation in both groups, this is not prohibitive. This supports carrying out more trials exclusively in older people. References 1. NIH, US national library of medicine.ClinicalTrials.gov Available at https://clinicaltrials.gov/

scholarly journals P166 Multimorbidity in SLE, a barrier to clinical trial eligibility: results from the BILAG-BR

Rheumatology ◽  
2021 ◽  
Vol 60 (Supplement_1) ◽  
Author(s):  
Sarah Dyball ◽  
Sophie Collinson ◽  
Emily Sutton ◽  
Eoghan McCarthy ◽  
Ben Parker ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Phase Iii ◽  
Research Support ◽  
Exclusion Criteria ◽  
Eligibility Criteria ◽  
Chi Squared ◽  
The Mean ◽  
Double Blinded ◽  
Age And Sex

Abstract Background/Aims  Stringent inclusion and exclusion criteria are employed in SLE clinical trials. Organ dysfunction and co-morbidities are common exclusion criteria which may affect how representative trials are of real-world SLE populations. We aimed to apply published trial eligibility criteria to patients with SLE in a large national register. Methods  A literature review of all major published double-blinded randomised phase III trials in non-renal SLE was performed. Common inclusion and exclusion criteria were applied to all patients recruited to the BILAG-Biologics Register (BILAG-BR), a large UK-wide register of SLE patients. Data on comorbidities for all patients registered was collected. The mean (SD) number of co-morbidities was calculated. Patients were then classified as being eligible or ineligible. Groups were compared initially using a chi-squared or Wilcoxon rank-sum test and logistic regression model was used to test the age and sex adjusted association between trial eligibility and comorbidities. Results  Common inclusion and exclusion criteria were identified from 12 published trials. When applied to the 837 patients recruited to BILAG-BR, 562 (67%) patients would not be eligible for inclusion in these trials. Ineligible patients had a shorter disease duration (2.9 vs. 5.1 years, p &lt; 0.01), but were similar in age (P = 1.0), sex (P = 0.7) and ethnicity (p = 0.5) to those who were eligible. Of eligible patients, 128 (53%) had 1 or more comorbidities compared with 340 (60%) who were ineligible (p = 0.05). The mean (SD) number of comorbidities was 0.9 (1.2) vs 1.2 (1.3) for eligible and ineligible patients respectively. After adjusting for age and sex, inclusion in clinical trials was associated with fewer comorbidities (OR 0.81, 95% CI 0.70, 0.94, p &lt; 0.01). Conclusion  Patients with multi-morbidity are more likely to be ineligible for SLE clinical trials. Evidence from real world studies and registers are therefore needed to fully understand the safety and effectiveness of new therapies. Our data also underscores the need to develop more pragmatic eligibility criteria for clinical trials. Disclosure  S. Dyball: None. S. Collinson: None. E. Sutton: None. E. McCarthy: None. B. Parker: Consultancies; GSK, AstraZenica, UCB, Abbvie, Pfizer, BMS, Celltrion. Grants/research support; GSK, Sanofi Genzyme. I. Bruce: Consultancies; GSK, Medimmune, AstraZenica, Eli Lilly, Merck Serono, UCB, ILTOO. Member of speakers’ bureau; AstraZeneca, Medimmune, GSK, UCB. Grants/research support; GSK, Genzyme Sanofi, UCB.

scholarly journals External validity of phase III trials on vaccines against SARS-CoV-2 to a middle-aged and elderly Western European population

2021 ◽  
Author(s):  
Natalie Terzikhan ◽  
Albert Hofman ◽  
Jaap Goudsmit ◽  
Mohammad Arfan Ikram
Keyword(s):  
High Risk ◽  
The Elderly ◽  
European Population ◽  
Phase Iii ◽  
Exclusion Criterion ◽  
Vaccination Programs ◽  
Vaccine Trials ◽  
Phase Iii Trials ◽  
Age Range ◽  
Ongoing Phase

AbstractInitial results from various phase-III trials on vaccines against SARS-CoV-2 are promising. For proper translation of these results to clinical guidelines, it is essential to determine how well the general population is reflected in the study populations of these trials. This study was conducted among 7162 participants (age-range: 51–106 years; 58% women) from the Rotterdam Study. We quantified the proportion of participants that would be eligible for the nine ongoing phase-III trials. We further quantified the eligibility among participants at high risk to develop severe COVID-19. Since many trials were not explicit in their exclusion criterion with respect to ‘acute’ or ‘unstable preexisting’ diseases, we performed two analyses. First, we included all participants irrespective of this criterion. Second, we excluded persons with acute or ‘unstable preexisting’ diseases. 97% of 7162 participants was eligible for any trial with eligibility for separate trials ranging between 11–97%. For high-risk individuals the corresponding numbers were 96% for any trial with separate trials ranging from 5–96%. Importantly, considering persons ineligible due to ‘acute’ or ‘unstable pre-existing’ disease drastically dropped the eligibilities for all trials below 43% for the total population and below 36% for high-risk individuals. The eligibility for ongoing vaccine trials against SARS-CoV-2 can reduce by half depending on interpretation and application of a single unspecified exclusion criterion. This exclusion criterion in our study would especially affect the elderly and those with pre-existing morbidities. These findings thus indicate the difficulty as well as importance of developing clinical recommendations for vaccination and applying these to the appropriate target populations. This becomes especially paramount considering the fact that many countries worldwide have initiated their vaccination programs by first targeting the elderly and most vulnerable persons.

Comorbidities limiting recruitment of colorectal cancer (CRC) patients in early-phase trials.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 791-791
Author(s):  
Narjust Duma ◽  
Yucai Wang ◽  
Miguel Gonzalez Velez ◽  
Sejal Kothadia ◽  
Veronica Mariotti ◽  
...  
Keyword(s):  
Phase I ◽  
Early Phase ◽  
Nyha Class ◽  
Anticoagulation Therapy ◽  
The United States ◽  
Exclusion Criterion ◽  
Eligibility Criteria ◽  
Trial Protocols ◽  
Early Phase Clinical Trials ◽  
Therapy Location

791 Background: With the surge of drug development in the past decade, early phase clinical trials (EPCT) have gained value evaluating the potential benefits of new therapies. The inclusion/exclusion criteria in EPCT are usually rigorous and may exclude many patients (pts) commonly seen in clinical practice. Our objective was to identify the most common comorbidities excluded in EPCT for CRC. Methods: ClinicalTrials.gov was queried on December 1stof 2015. We reviewed the characteristics and eligibility criteria of 369 phase I/II interventional drug trials including: experimental arm therapy, location, and exclusion/inclusion criteria. Logistic regressions were completed and exclusion was studied as a binary variable. Results: Of the 369 trials, 68% were phase II and 32% phase I. 46% were conducted in the United States, 30% in Europe, 15% in Asia and 9% in other locations. 74 (20%) trials excluded pts > 70 years of age. 142 (39%) trials required creatinine levels < 1.5 mg/dl, liver enzymes (AST/ALT) < 2.5 and bilirubin < 1.5 of the upper limit of normal. Cytopenia was a significant exclusion factor: 147 (47%) trials required Hgb > 9 g/dl and 218 (59%) excluded pts with platelets < 100,000/dl. In terms of comorbidities, 98 (27%) trials excluded pts with heart failure (NYHA class 3/4), 74 (20%) with atrial fibrillation, 112 (31%) with any anticoagulation therapy and 155 (42%) with positive HIV. Trials located in the US were more likely to exclude pts with Hgb < 9g/dl (OR: 1.5, 95%CI: 1.1-2.3, p < 0.05), immunotherapy trials were more likely to exclude pts on any anticoagulation (OR:1.8, 95%CI: 1.2-2.8, p < 0.007) and targeted therapy trials were more likely to exclude pts with history of DVT/PE or cardiovascular diseases (OR: 3.4, 95%CI: 1.9-5.8, p < 0.0001; OR: 2.3, 95%CI: 1.3-3.8, p < 0.002, respectively). Conclusions: 20% of EPCTs on CRC excluded pts with advanced age, organ dysfunction and common comorbidities. Many of the EPCT reviewed were not inclusive of our aging oncology population who are more likely to have multiple comorbidities. Investigators should review whether sufficient justification exists for every exclusion criterion before their incorporation in future trial protocols.

scholarly journals Measuring frailty in younger populations: a rapid review of evidence

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e047051
Author(s):  
Gemma F Spiers ◽  
Tafadzwa Patience Kunonga ◽  
Alex Hall ◽  
Fiona Beyer ◽  
Elisabeth Boulton ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Predictive Validity ◽  
Data Extraction ◽  
Grey Literature ◽  
Frailty Index ◽  
Study Data ◽  
Rapid Review ◽  
Eligibility Criteria ◽  
Adult Age ◽  
The Impact

ObjectivesFrailty is typically assessed in older populations. Identifying frailty in adults aged under 60 years may also have value, if it supports the delivery of timely care. We sought to identify how frailty is measured in younger populations, including evidence of the impact on patient outcomes and care.DesignA rapid review of primary studies was conducted.Data sourcesFour databases, three sources of grey literature and reference lists of systematic reviews were searched in March 2020.Eligibility criteriaEligible studies measured frailty in populations aged under 60 years using experimental or observational designs, published after 2000 in English.Data extraction and synthesisRecords were screened against review criteria. Study data were extracted with 20% of records checked for accuracy by a second researcher. Data were synthesised using a narrative approach.ResultsWe identified 268 studies that measured frailty in samples that included people aged under 60 years. Of these, 85 studies reported evidence about measure validity. No measures were identified that were designed and validated to identify frailty exclusively in younger groups. However, in populations that included people aged over and under 60 years, cumulative deficit frailty indices, phenotype measures, the FRAIL Scale, the Liver Frailty Index and the Short Physical Performance Battery all demonstrated predictive validity for mortality and/or hospital admission. Evidence of criterion validity was rare. The extent to which measures possess validity across the younger adult age (18–59 years) spectrum was unclear. There was no evidence about the impact of measuring frailty in younger populations on patient outcomes and care.ConclusionsLimited evidence suggests that frailty measures have predictive validity in younger populations. Further research is needed to clarify the validity of measures across the adult age spectrum, and explore the utility of measuring frailty in younger groups.

scholarly journals AB0332 IMMUNOSUPPRESSIVE AND IMMONOMODULATING AGENTS IN RHEUMATOID ARTHRITIS: A SYSTEMATIC REVIEW OF CLINICAL TRIALS AND THEIR CURRENT DEVELOPMENT STAGE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1464.1-1465
Author(s):  
J. Blaess ◽  
J. Walther ◽  
J. E. Gottenberg ◽  
J. Sibilia ◽  
L. Arnaud ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
B Cells ◽  
Phase I ◽  
Phase Ii ◽  
Clinical Development ◽  
Phase Iii ◽  
Jak Inhibitors ◽  
Exclusion Criteria ◽  
Immunomodulating Drugs

Background:Rheumatoid arthritis (RA) is the most frequent chronic inflammatory diseases with an incidence of 0.5% to 1%. Therapeutic arsenal of RA has continuously expanded in recent years with the recent therapeutic progress with the arrival of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biological (bDMARDs) and targeted synthetic (tsDMARDs), JAK inhibitors. However, there are still some unmet needs for patients who do not achieve remission and who continue to worsen despite treatments. Of note, only approximately 40% of patients are ACR70 responders, in most randomized controlled trials. For these patients, finding new therapeutic avenues is challenging.Objectives:The objective of our study was to analyze the whole pipeline of immunosuppressive and immunomodulating drugs evaluated in RA and describe their mechanisms of action and stage of clinical development.Methods:We conducted a systematic review of all drug therapies in clinical development in RA in 17 databases of international clinical trials. Inclusion criterion: study from one of the databases using the keywords “Rheumatoid arthritis” (search date: June 1, 2019). Exclusion criteria: non-drug trials, trials not related to RA or duplicates. We also excluded dietary regimen or supplementations, cellular therapies, NSAIDs, glucorticoids or their derivatives and non-immunosuppressive or non-immunomodulating drugs. For each csDMARD, bDMARD and tsDMARD, we considered the study at the most advanced stage. For bDMARDs, we did not take into account biosimilars.Results:The research identified 4652 trials, of which 242 for 243 molecules met the inclusion and exclusion criteria. The developed molecules belong to csDMARDs (n=21), bDMARDs (n=117), tsDMARDs (n=105).Among the 21 csDMARDs molecules: 8 (38%) has been withdrawn, 4 (19%) are already labelled in RA (hydroxychloroquine, leflunomide, methotrexate and sulfasalazine) and 9 (43%) are in development: 1 (11%) is in phase I/II, 5 (56%) in phase II, 3 (33%) in phase IV.Among the 117 bDMARDs molecules: 69 (59%) has been withdrawn, 9 (8%) are labeled in RA (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab) and 39 (33%) are in development: 9 (23%) in phase I, 3 (8%) in phase I/II, 21 (54%) in phase II, 5 (12%) are in phase III, 1 (3%) in phase IV. bDMARDs currently under development target B cells (n=4), T cells (n=2), T/B cells costimulation (n=2),TNF alpha (n=2), Interleukine 1 or his receptor (n=3), Interleukine 6 or his receptor (n=7), Interleukine 17 (n=4), Interleukine 23 (n=1), GM-CSF (n=1), other cytokines or chemokines (n=5), integrins or adhesion proteins (n=3), interferon receptor (n=1) and various other targets (n=4).Among the 105 tsDMARDs molecules: 64 (61%) has been withdrawn, 6 (6%) JAK inhibitors, have just been or will probably soon be labelled (baricitinib, filgotinib, peficitinib, tofacitinib and upadacitinib), 35 (33%) are in development: 8 (24%) in phase I, 26 (74%) in phase II, 1 (3%) in phase III and. tsDMARDs currently under development target tyrosine kinase (n=12), janus kinase (JAK) (n=3), sphingosine phostate (n=3), PI3K pathway (n=1), phosphodiesterase-4 (n=3) B cells signaling pathways (n=3) and various other targets (n=10).Conclusion:A total of 242 therapeutic trials involving 243 molecules have been or are being evaluated in RA. This development does not always lead to new treatments since 141 (58%) have already been withdrawn. Hopefully, some of the currently evaluated drugs will contribute to improve the therapeutic management of RA patients, requiring a greater personalization of therapeutic strategies, both in the choice of molecules and their place in therapeutic sequences.Disclosure of Interests:Julien Blaess: None declared, Julia Walther: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Jean Sibilia: None declared, Laurent Arnaud: None declared, Renaud FELTEN: None declared

scholarly journals Identifying enablers and barriers to referral, uptake and completion of lifestyle modification programmes: a rapid literature review

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e045094
Author(s):  
Yvonne Zurynski ◽  
Carolynn Smith ◽  
Joyce Siette ◽  
Bróna Nic Giolla Easpaig ◽  
Mary Simons ◽  
...  
Keyword(s):  
Chronic Disease ◽  
Lifestyle Modification ◽  
Data Extraction ◽  
Empirical Studies ◽  
Grey Literature ◽  
International Health ◽  
Rapid Review ◽  
Eligibility Criteria ◽  
Relevant Evidence ◽  
Literature Reviews

ObjectiveTo identify current, policy-relevant evidence about barriers and enablers associated with referral, uptake and completion of lifestyle modification programmes (LMPs) for secondary prevention of chronic disease in adults.DesignA rapid review, co-designed with policymakers, of peer-reviewed and grey literature using a modified Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework.Data sourcesMedline, Embase, Scopus, PsycINFO and CINAHL were searched for relevant studies and literature reviews. Grey literature was identified through Advanced Google searching and targeted searching of international health departments’ and non-government organisations’ websites.Eligibility criteria for selecting studiesDocuments published 2010–2020, from high-income countries, reporting on programmes that included referral of adults with chronic disease to an LMP by a health professional (HP).Data extraction and synthesisData from grey and peer-reviewed literature were extracted by two different reviewers. Extracted data were inductively coded around emergent themes. Regular meetings of the review group ensured consistency of study selection and synthesis.ResultsTwenty-nine documents were included: 14 grey literature, 11 empirical studies and four literature reviews. Key barriers to HPs referring patients included inadequate HP knowledge about LMPs, perceptions of poor effectiveness of LMPs and perceptions that referral to LMPs was not part of their role. Patient barriers to uptake and completion included poor accessibility and lack of support to engage with the LMPs. Enablers to HP referral included training/education, effective interdisciplinary communication and influential programme advocates. Support to engage with LMPs after HP referral, educational resources for family members and easy accessibility were key enablers to patient engagement with LMPs.ConclusionsFactors related to HPs’ ability and willingness to make referrals are important for the implementation of LMPs, and need to be coupled with support for patients to engage with programmes after referral. These factors should be addressed when implementing LMPs to maximise their impact.

Sign in / Sign up

Export Citation Format

Share Document