LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 10 of total 734

Search options

  1. Article ; Online: Observational studies to emulate randomized trials: Some real-world barriers.

    Suissa, Samy

    British journal of clinical pharmacology

    2024  Volume 90, Issue 4, Page(s) 1193–1198

    Abstract: The randomized controlled trial (RCT) forms the basis for drug approval by regulatory agencies. Observational studies using existing data from healthcare databases now also provide real-world evidence (RWE) in regulatory decision-making. Several ... ...

    Abstract The randomized controlled trial (RCT) forms the basis for drug approval by regulatory agencies. Observational studies using existing data from healthcare databases now also provide real-world evidence (RWE) in regulatory decision-making. Several initiatives are assessing the value of RWE by conducting observational studies that emulate published RCTs. While many RCTs are straightforward to emulate, others are challenging. We describe three RCT design aspects that pose challenges for observational studies. First are trials that enrol already treated subjects who must discontinue these treatments at the time of randomization, which can distort the comparison with observational studies. Second is the inclusion of a run-in phase, especially to exclude non-compliant subjects from the trial. Third are trials that evaluate the effect of weaning off treatment. In conclusion, future randomized trials that aim to be emulated by observational studies could consider study designs that allow emulation and thus provide valid and complementary RWE.
    MeSH term(s) Humans ; Randomized Controlled Trials as Topic ; Research Design ; Observational Studies as Topic
    Language English
    Publishing date 2024-01-15
    Publishing country England
    Document type Journal Article
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.15998
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 1118: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  2. Article ; Online: Guidelines for the Pharmacologic Treatment of COPD 2023: Canada versus GOLD.

    Suissa, Samy

    COPD

    2024  Volume 21, Issue 1, Page(s) 2292613

    MeSH term(s) Humans ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Canada ; Practice Patterns, Physicians' ; Guideline Adherence
    Language English
    Publishing date 2024-02-08
    Publishing country England
    Document type Editorial
    ZDB-ID 2171107-0
    ISSN 1541-2563 ; 1541-2555
    ISSN (online) 1541-2563
    ISSN 1541-2555
    DOI 10.1080/15412555.2023.2292613
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5990: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  3. Article: Triple therapy in COPD: understanding the data.

    Suissa, Samy

    ERJ open research

    2023  Volume 9, Issue 1

    Abstract: Effectiveness of single-inhaler triple therapy on exacerbation risk and mortality in COPD is exaggerated in IMPACT and ETHOS trials from confounding by prior ICS discontinuation: effectiveness fades in analyses and studies with no prior ICS ... ...

    Abstract Effectiveness of single-inhaler triple therapy on exacerbation risk and mortality in COPD is exaggerated in IMPACT and ETHOS trials from confounding by prior ICS discontinuation: effectiveness fades in analyses and studies with no prior ICS discontinuation
    Language English
    Publishing date 2023-01-30
    Publishing country England
    Document type Editorial
    ZDB-ID 2827830-6
    ISSN 2312-0541
    ISSN 2312-0541
    DOI 10.1183/23120541.00615-2022
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  4. Article ; Online: Simplifying pharmacotherapy for patients with COPD: a viewpoint.

    Suissa, Samy

    The European respiratory journal

    2023  Volume 62, Issue 6

    MeSH term(s) Humans ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Bronchodilator Agents/therapeutic use
    Chemical Substances Bronchodilator Agents
    Language English
    Publishing date 2023-12-14
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.01510-2023
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 2322: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 292: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  5. Article ; Online: Single-inhaler triple

    Suissa, Samy

    The European respiratory journal

    2023  Volume 62, Issue 3

    MeSH term(s) Humans ; Bronchodilator Agents/therapeutic use ; Nebulizers and Vaporizers ; Administration, Inhalation ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Muscarinic Antagonists/therapeutic use ; Adrenergic beta-2 Receptor Agonists/therapeutic use ; Drug Combinations ; Drug Therapy, Combination
    Chemical Substances Bronchodilator Agents ; Muscarinic Antagonists ; Adrenergic beta-2 Receptor Agonists ; Drug Combinations
    Language English
    Publishing date 2023-09-09
    Publishing country England
    Document type Letter ; Research Support, Non-U.S. Gov't
    ZDB-ID 639359-7
    ISSN 1399-3003 ; 0903-1936
    ISSN (online) 1399-3003
    ISSN 0903-1936
    DOI 10.1183/13993003.00883-2023
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 2322: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 292: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  6. Article ; Online: Inhaled Corticosteroids and Mortality in COPD: Biases in Randomized Trials.

    Suissa, Samy

    Chest

    2022  Volume 162, Issue 6, Page(s) e333–e334

    Language English
    Publishing date 2022-08-11
    Publishing country United States
    Document type Letter
    ZDB-ID 1032552-9
    ISSN 1931-3543 ; 0012-3692
    ISSN (online) 1931-3543
    ISSN 0012-3692
    DOI 10.1016/j.chest.2022.08.2237
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Ui III Zs.45: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)
    Zs.MO 349: Show issues

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  7. Article ; Online: Antifibrotics and Reduced Mortality in Idiopathic Pulmonary Fibrosis: Immortal Time Bias.

    Suissa, Samy / Suissa, Karine

    American journal of respiratory and critical care medicine

    2022  Volume 207, Issue 1, Page(s) 105–109

    MeSH term(s) Humans ; Idiopathic Pulmonary Fibrosis ; Bias
    Language English
    Publishing date 2022-08-11
    Publishing country United States
    Document type Letter
    ZDB-ID 1180953-x
    ISSN 1535-4970 ; 0003-0805 ; 1073-449X
    ISSN (online) 1535-4970
    ISSN 0003-0805 ; 1073-449X
    DOI 10.1164/rccm.202207-1301LE
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Uh II Zs.80: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  8. Article ; Online: Perplexing mortality data from triple therapy trials in COPD.

    Suissa, Samy

    The Lancet. Respiratory medicine

    2021  Volume 9, Issue 7, Page(s) 684–685

    MeSH term(s) Administration, Inhalation ; Adrenal Cortex Hormones/administration & dosage ; Adrenal Cortex Hormones/therapeutic use ; Adrenergic beta-2 Receptor Agonists/therapeutic use ; Bronchodilator Agents/administration & dosage ; Bronchodilator Agents/therapeutic use ; Drug Therapy, Combination ; Humans ; Muscarinic Antagonists/therapeutic use ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Pulmonary Disease, Chronic Obstructive/mortality
    Chemical Substances Adrenal Cortex Hormones ; Adrenergic beta-2 Receptor Agonists ; Bronchodilator Agents ; Muscarinic Antagonists
    Language English
    Publishing date 2021-06-11
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2686754-0
    ISSN 2213-2619 ; 2213-2600
    ISSN (online) 2213-2619
    ISSN 2213-2600
    DOI 10.1016/S2213-2600(21)00238-1
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 7041: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  9. Article ; Online: Ten Commandments for Randomized Trials of Pharmacological Therapy for COPD and Other Lung Diseases.

    Suissa, Samy

    COPD

    2021  Volume 18, Issue 5, Page(s) 485–492

    Abstract: The randomized controlled trial is the quintessential scientific tool to evaluate the effectiveness and safety of medications. While early trials of drugs used for the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory ... ...

    Abstract The randomized controlled trial is the quintessential scientific tool to evaluate the effectiveness and safety of medications. While early trials of drugs used for the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory diseases were generally unambiguous, more recent studies have been controversial. It has become evident that the conduct, design and analysis of these trials were highly variable and may have been responsible for incoherencies in results and interpretation. With the advent of new studies, the need for guiding principles for the conduct of future randomized trials has become manifest. We describe the concept of the counterfactual principle as it applies to the treatment of patients and to the randomized trial. We then present ten methodological tenets for the design and statistical aspects of randomized controlled trials evaluating the effectiveness of drugs used in the treatment of several respiratory diseases. They include eight study design and two statistical analysis principles: 1) Study question; 2) Intervention; 3) Study population; 4) Blinding; 5) Run-in period; 6) Follow-up; 7) Outcome; 8) Safety; 9) Intent-to-treat; 10) Covariate adjustment. These tenets are described using mainly examples from trials of pharmacological treatments for COPD, as well as some from asthma and idiopathic pulmonary fibrosis, conducted over the last 30 years. The careful application of these principles in the conduct of randomized trials will provide rigorous studies and improve the validity of results. The ensuing clearer interpretation of findings will permit their well-founded contribution to treatment guidelines and optimal clinical management.
    MeSH term(s) Humans ; Pulmonary Disease, Chronic Obstructive/drug therapy ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2021-09-01
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2171107-0
    ISSN 1541-2563 ; 1541-2555
    ISSN (online) 1541-2563
    ISSN 1541-2555
    DOI 10.1080/15412555.2021.1968816
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5990: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  10. Article ; Online: Triple Therapy in COPD: Time for Adaptive Selection Trials.

    Suissa, Samy

    COPD

    2021  Volume 18, Issue 6, Page(s) 597–601

    Abstract: Recent trials reported significant reductions in all-cause mortality with single-inhaler triple therapy for chronic obstructive pulmonary disease (COPD). However, reviews of these trials identified inconsistencies in the findings and methodological ... ...

    Abstract Recent trials reported significant reductions in all-cause mortality with single-inhaler triple therapy for chronic obstructive pulmonary disease (COPD). However, reviews of these trials identified inconsistencies in the findings and methodological issues with the design and analysis, including the "adverse impact of inhaled corticosteroid (ICS) withdrawal rather than the addition" of the triple therapy. Indeed, ICS were discontinued in over 70% of the patients in these trials and 40% already using triple therapy, muddying the interpretation of the data. The "adaptive" clinical trial design is an efficient approach that allows continual modification of the study treatment allocation during follow-up. In this article, we propose the "adaptive selection" trial design, which applies the adaptive concept to the selection of patients into the trial by adapting the randomization choices to the treatment already used by the patients. With such a design, patients already on triple therapy would be excluded outright from trials of triple therapy effectiveness, while the others are randomly allocated to specific treatment arms according to their current treatment, avoiding issues of treatment withdrawal effects. Adaptive selection trials should be the norm for studies of COPD therapies. This approach would avoid the vexing effects of treatment withdrawal that have afflicted the recent triple therapy trials. This concept of adaptive selection has been applied in COPD to the question of whether patients can be safely de-escalated from ICS. It is time to also apply it to studies of the effectiveness of treatment escalation.
    MeSH term(s) Administration, Inhalation ; Adrenal Cortex Hormones/therapeutic use ; Adrenergic beta-2 Receptor Agonists/therapeutic use ; Bronchodilator Agents/therapeutic use ; Drug Therapy, Combination ; Humans ; Muscarinic Antagonists/therapeutic use ; Pulmonary Disease, Chronic Obstructive/drug therapy
    Chemical Substances Adrenal Cortex Hormones ; Adrenergic beta-2 Receptor Agonists ; Bronchodilator Agents ; Muscarinic Antagonists
    Language English
    Publishing date 2021-09-27
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2171107-0
    ISSN 1541-2563 ; 1541-2555
    ISSN (online) 1541-2563
    ISSN 1541-2555
    DOI 10.1080/15412555.2021.1982886
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.A 5990: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

To top