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Clinical research methodology process: what has changed with COVID-19?

ABSTRACT: The immediate repercussions of the pandemic on clinical research were the systematic interruption of ongoing studies and the explosion of tens of thousands of anti-COVID-19 research protocols reported in fragmented, uncoordinated, often technically insufficient international registers, from which almost nothing of significance was produced. In the first two years of intensive research, anti-inflammatory and anticoagulant benefits were identified, while the systemic nature of the viral disease was clearly manifested, but no specific antiviral drugs emerged. Subsequently, monoclonal antibodies and antiviral drugs such as Ritonavir-Boosted Nirmatrelvir (Paxlovid) have given way to more specific therapies, even if surprisingly little used. Finally, the new national Electronic Health Record (EHR-FSE2 Fascicolo Sanitario Elettronico 2 in Italian) was approved as a law, which will integrate the previous one, which is in fact not functional. The systematic, orderly and complete collection of the health data of each citizen constitutes a radical modification of the current National Health System, epidemiology and clinical research.

SUBMITTER: Tavazzi L

PROVIDER: S-EPMC9653140 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

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Clinical research methodology process: what has changed with COVID-19?

Tavazzi Luigi L

European heart journal supplements : journal of the European Society of Cardiology 20221112 Suppl I

The immediate repercussions of the pandemic on clinical research were the systematic interruption of ongoing studies and the explosion of tens of thousands of anti-COVID-19 research protocols reported in fragmented, uncoordinated, often technically insufficient international registers, from which almost nothing of significance was produced. In the first two years of intensive research, anti-inflammatory and anticoagulant benefits were identified, while the systemic nature of the viral disease wa ...[more]

PMID: 36380784

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Project description:Aims: Italy was one of the first countries to be significantly affected by the coronavirus disease 2019 (COVID-19) pandemic, determining a unique scenario for Italian psychotherapists to consider changing the modality in which they deliver treatment. The present study aimed at studying which factors related to psychotherapists and their clinical practice had a major role in predicting two main outcomes: (1) the rate of interrupted treatments during lockdown and (2) psychotherapists' satisfaction with the telepsychotherapy modality. Methods: An online survey was administered to licensed psychotherapists (n = 306), who worked mainly as private practitioners, between April 5 and May 10, 2020 (i.e., the peak of the pandemic in Italy). Results: Psychotherapists reported that 42.1% (SD = 28.9) of their treatments had been interrupted, suggesting that Italy faced an important undersupply of psychotherapy during the lockdown. Using the Akaike information criterion (AIC) model selection, we identified three predictors of the rate of interrupted treatments: (1) psychotherapists' lack of experience with telepsychotherapy prior to the lockdown, (2) their theoretical orientation (with cognitive behavioral psychotherapists reporting a higher rate of interrupted treatments), and (3) patients' lack of privacy at home, as reported to the psychotherapists. Furthermore, we found four predictors of psychotherapists' satisfaction with the telepsychotherapy modality: (1) the rate of interrupted treatments, (2) psychotherapists' previous experience with telepsychotherapy, (3) their beliefs about the compatibility of telepsychotherapy with their theoretical orientation, and (4) their use of a video-conferencing modality, rather than telephone. Conclusion: The following recommendations can help policy makers, professional associations, and practitioners in promoting the continuity of psychotherapy treatments during the COVID-19 outbreak and in future emergencies: (i) disseminating training programs for practitioners on telepsychotherapy, (ii) supporting patients to pragmatically access a private space at home, (iii) encouraging practitioners to use video-conferencing (instead of telephone) to deliver remote therapy, and (iv) increasing the acceptance of telepsychotherapy among both clinicians and the general public.

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Clinical research methodology process: what has changed with COVID-19?

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Clinical research methodology process: what has changed with COVID-19?

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