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1.
Arch Cardiol Mex ; 91(Supl): 25-33, 2021.
Article in English | MEDLINE | ID: covidwho-2316980

ABSTRACT

INTRODUCCIÓN: La pandemia de enfermedad por coronavirus 2019 (COVID-19) ha incidido de forma negativa en los programas de rehabilitación cardiaca (PRC) españoles. OBJETIVO: Este trabajo tiene como objetivo fundamental el analizar la posibilidad de mantenerlos abiertos y como secundario valorar si se mantienen los beneficios demostrados a nivel físico y psicológico. MÉTODOS: Analizamos los resultados de nuestro PRC en el año 2020 (119 pacientes) y los comparamos con los del año 2019 (121 pacientes), libre de COVID-19. Se comparan distintas variables generales, y los resultados obtenidos en capacidad física, a nivel psicológico, así como las complicaciones y abandonos. RESULTADOS: No existen diferencias significativas entre ambos grupos en la edad (61.6 vs. 61.5), sexo (mujeres: 12.6 vs. 14.8%), diagnóstico de cardiopatía isquémica (106 vs. 99) y fracción de eyección de ventrículo izquierdo (55.9 vs. 55.8%). La ansiedad media-alta fue superior al inicio (p = 0.02) y final (p = 0.002) del programa en el año 2019, así como las puntuaciones del patrón de conducta tipo A (p = 0.041 vs. 0.034). El porcentaje de depresión fue similar. Más del 95% de los pacientes del año 2020 referían miedo al contagio. La capacidad funcional aumentó, pero menos en el año 2020 (p = 0.001). La duración del programa fue superior en el año 2020 (p = 0.001). Los abandonos (15 vs. 11 pacientes) no mostraron diferencias significativas. CONCLUSIONES: Los PRC en época COVID-19 son posibles y siguen mostrando beneficios. La duración del programa fue mayor por periodos de falta de asistencia. La menor capacidad física puede estar relacionada con el uso de la mascarilla. INTRODUCTION: COVID-19 pandemic has had a negative impact on Spanish Cardiac Rehabilitation Programmes (CRP). OBJECTIVES: The main objective of this study is to analyze the possibility of keeping these units open and, secondly, to assess whether demonstrated physical and psychological benefits are preserved. METHODS: We analyzed results of our CRP in 2020 (119 patients) and compared them with those of 2019 (121 patients), year free of Covid. We compare different general variables, and results obtained in physical capacity, psychological level, as well as complications and dropouts. RESULTS: There were no significant differences between two groups in age (61.6 vs. 61.5), sex (women: 12.6% vs. 14.8%), diagnosis of ischemic heart disease (106 vs. 99) and left ventricular ejection fraction (55.9% vs. 55.8%). Mean-high anxiety was higher at baseline (p = 0.02) and endline (p = 0.002) of program in 2019, as well as type A behavior pattern scores (p=0.041 and 0.034). Percentage of depression was similar. More than 95% of patients in 2020 reported fear of infection. Functional capacity increased, but less in 2020 (p = 0.001). Programme duration was longer in 2020 (p=0.001). Dropouts (15 vs. 11 patients) showed no significant differences. CONCLUSIONS: CR programmes in COVID-19 era are possible and continue to show benefits. The duration of programme was longer due to periods of non-attendance. Lower physical capacity may be related to mask use.


Subject(s)
COVID-19 , Cardiac Rehabilitation , Female , Humans , Male , Middle Aged , Pandemics , Patient Dropouts , Retrospective Studies , Spain , Stroke Volume , Ventricular Function, Left
2.
Intern Med ; 61(20): 3017-3028, 2022 Oct 15.
Article in English | MEDLINE | ID: covidwho-2079919

ABSTRACT

Objective This retrospective, single-center study assessed the effects of interferon (IFN)-free treatment of hepatitis C virus (HCV) infection, which has been approved for seven years; calculated the incidence of hepatocellular carcinoma (HCC) after achieving a sustained virologic response (SVR); and elucidated problems with follow-up for surveillance of post-SVR HCC, particularly the impact of the coronavirus disease 2019 (COVID-19) pandemic. Methods We summarized the SVR achievement rate of 286 HCV-infected patients who received 301 IFN-free treatments and analyzed the cumulative incidence of initial HCC and the cumulative continuation rate of follow-up after SVR in the 253 patients who achieved SVR and did not have a history of HCC. Results Among 286 patients who received IFN-free treatments, 14 dropped out, and the 272 remaining patients achieved an SVR after receiving up to third-line treatment. Post-SVR HCC occurred in 18 (7.1%) of the 253 patients without a history of HCC, with a cumulative incidence at 3 and 5 years after SVR of 6.6% and 10.0%, respectively; the incidence of cirrhosis at those time points was 18.2% and 24.6%, respectively.Of the 253 patients analyzed, 58 (22.9%) discontinued follow-up after SVR. Patients who had no experience with IFN-based therapy tended to drop out after SVR. Notably, the number of dropouts per month has increased since the start of the pandemic. Conclusion Currently, IFN-free treatment is showing great efficacy. However, the incidence of HCC after SVR should continue to be monitored. In this study, the COVID-19 pandemic did not affect treatment outcomes, but it may affect surveillance for post-SVR HCC.


Subject(s)
Carcinoma, Hepatocellular , Hepatitis C, Chronic , Liver Neoplasms , Antiviral Agents/therapeutic use , Carcinoma, Hepatocellular/epidemiology , Carcinoma, Hepatocellular/virology , Hepacivirus , Hepatitis C, Chronic/complications , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/epidemiology , Humans , Interferons/therapeutic use , Liver Neoplasms/epidemiology , Liver Neoplasms/virology , Patient Dropouts , Retrospective Studies , Sustained Virologic Response
3.
BMJ ; 375: e067742, 2021 12 14.
Article in English | MEDLINE | ID: covidwho-1574061

ABSTRACT

OBJECTIVES: To determine the effectiveness of sending Christmas cards to participants in randomised controlled trials to increase retention rate at follow-ups, and to explore the feasibility of doing a study within a trial (SWAT) across multiple host trials simultaneously. DESIGN: Randomised SWAT conducted simultaneously across eight host trials. SETTING: Eight randomised controlled trials researching various areas including surgery and smoking cessation. PARTICIPANTS: 3223 trial participants who were still due at least one follow-up from their host randomised controlled trial. INTERVENTION: Participants were randomised (1:1, separately by each host trial) to either received a Christmas card in mid-December 2019 or to not receive a card. MAIN OUTCOME MEASURE: Proportion of participants completing their next follow-up (retention rate) within their host randomised controlled trial. RESULTS: 1469 participants (age 16-94 years; 70% (n=1033) female; 96% (813/847) white ethnicity) across the eight host randomised controlled trials were involved in the analysis (cut short owing to covid-19). No evidence was found of a difference in retention rate between the two arms for any of the host trials when analysed separately or when the results were combined (85.3% (639/749) for cards versus 85.4% (615/720) for no card; odds ratio 0.96, 95% confidence interval 0.71 to 1.29; P=0.77). No difference was observed when comparing just participants who were due a follow-up in the 30 days after receiving the card (odds ratio 0.96, 0.42 to 2.21). No evidence of a difference in time to complete the questionnaire was found (hazard ratio 1.01, 95% confidence interval 0.91 to 1.13; P=0.80). These results were robust to post hoc sensitivity analyses. The cost of this intervention was £0.76 (€0.91; $1.02) per participant, and it will have a carbon footprint of approximately 140 g CO2 equivalent per card. One benefit of this approach was the need to only submit one ethics application. CONCLUSIONS: Sending Christmas cards to participants in randomised controlled trials does not increase retention. Undertaking a SWAT within multiple randomised controlled trials at the same time is, however, possible. This approach should be used more often to build an evidence base to support selection of recruitment and retention strategies. Although no evidence of a boost to retention was found, embedding a SWAT in multiple host trials simultaneously has been shown to be possible. STUDY REGISTRATION: SWAT repository https://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/FileStore/Filetoupload,846275,en.pdf#search=SWAT%2082.


Subject(s)
Holidays , Patient Dropouts , Randomized Controlled Trials as Topic , Adolescent , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , United Kingdom , Young Adult
4.
Microbes Infect ; 23(9-10): 104851, 2021.
Article in English | MEDLINE | ID: covidwho-1267864

ABSTRACT

Since the start of the COVID-19 pandemic, experts and the broader public have vigorously debated the means by which SARS CoV-2 is spread. And understandably so, for identifying the routes of transmission is crucial for selecting appropriate nonpharmaceutical interventions to control the pandemic. The most controversial question in the debate is the role played by airborne transmission. What is at stake is not just the clinical evidence, but the implications for public health policy, society, and psychology. Interestingly, however, the issue of airborne transmission is not a new controversy. It has reappeared throughout the history of western medicine. This essay traces the notion of airborne infection from its development in ancient medical theories to its manifestation in the modern era and its impact today.


Subject(s)
Air Microbiology , COVID-19/transmission , SARS-CoV-2 , Aerosols , COVID-19/epidemiology , History of Medicine , Humans , Pandemics , Patient Dropouts
5.
Int Arch Allergy Immunol ; 182(7): 631-636, 2021.
Article in English | MEDLINE | ID: covidwho-1197289

ABSTRACT

BACKGROUND: Subcutaneous allergen immunotherapy (SCIT) is an effective treatment for allergic rhinitis, asthma, and venom allergy. Compliance is essential for SCIT to obtain maximal benefit as it is a long-term treatment. OBJECTIVES: This study aimed to determine the level of real-life SCIT compliance in pediatric patients and the associated factors. Additional aims were to determine how SCIT compliance was affected by the COVID-19 pandemic and why some patients dropped out SCIT. METHOD: Pediatric patients diagnosed with allergic rhinitis, allergic asthma, or venom allergy that received SCIT between September 2012 and July 2020 were analyzed. RESULTS: The study included 201 children (66.7% male) with a median (interquartile range) age of 12.8 years (9.4-15.2) at the time of the first SCIT injection. The overall compliance rate before COVID-19 pandemic was 86.1%. Short SCIT follow-up time and venom anaphylaxis were found to be risk factors for drop out. The leading causes of drop outs were moving to another city/country (32.1%), symptom improvement (17.8%), treatment ineffectiveness (14.2%), and adverse reactions (14.2%). Among the 108 patients that were still receiving SCIT during the COVID-19 pandemic, 31 (28.7%) dropped out the therapy. The most frequent reasons for drop-out were fear of being infected with COVID-19 (35.4%) and thinking that the AIT practise stopped due to COVID-19 pandemic (29%). Male gender and older age were found to be the independent risk factors for drop-out of SCIT. CONCLUSIONS: Real life compliance in children was found 13.9% and it was higher than adults. Nearly one-third of children dropped out during the CO-VID-19 pandemic. Male gender and older age are associated with SCIT drop-out during the COVID-19 pandemic.


Subject(s)
COVID-19 , Desensitization, Immunologic , Hypersensitivity, Immediate/therapy , Patient Compliance/statistics & numerical data , Adolescent , COVID-19/prevention & control , COVID-19/psychology , Child , Desensitization, Immunologic/adverse effects , Desensitization, Immunologic/methods , Desensitization, Immunologic/psychology , Desensitization, Immunologic/statistics & numerical data , Female , Humans , Injections, Subcutaneous , Logistic Models , Male , Patient Compliance/psychology , Patient Dropouts/psychology , Patient Dropouts/statistics & numerical data , Turkey
6.
Minerva Surg ; 76(1): 57-61, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1147343

ABSTRACT

BACKGROUND: Obesity represents a risk factor for COVID-19 infection. Therefore, in order to reduce COVID-19 related comorbidities in obese population a continuation of obesity treatment is needed. However, bariatric procedures were postponed because of COVID-19 restrictions, delaying treatment for obese patients seeking for surgery. This study aimed to test the feasibility of a telematics pre-operative psychological and nutritional assessment as an alternative tool during COVID-19 outbreak. METHODS: Twenty-six patients were contacted. The pre-operative assessment consisted in 3-weekly one-to-one online sessions and a final in-person multidisciplinary session. The protocol feasibility has been evaluated on the following outcome: rejection rate (%), dropout rate (%), compliance and satisfaction's degree. RESULTS: Eighteen participants completed the whole protocol and 10% dropped-out. Seventy-two percent of participants obtained an excess weight loss ≥5%. All participants were satisfied of the telematics assessment. CONCLUSIONS: COVID-19 emergency has changed standard hospital procedures and this study could represent a landmark for an online pre-operative assessment method to adopt in case of new restrictions.


Subject(s)
Bariatric Surgery , COVID-19/prevention & control , Nutrition Assessment , Preoperative Care/methods , Psychological Tests , Social Media , Adult , Feasibility Studies , Female , Humans , Internet-Based Intervention , Male , Patient Compliance/statistics & numerical data , Patient Dropouts/statistics & numerical data , Patient Satisfaction/statistics & numerical data , Pilot Projects , Prospective Studies , Weight Loss
7.
Expert Rev Clin Pharmacol ; 14(4): 439-444, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1121131

ABSTRACT

Introduction: Randomized clinical trials (RCTs) are useful to study the role of individual and contextual factors in which therapies vs placebos are administered and to provide an important perspective for understanding the phenomenon of nocebo-related risks.Areas covered: The results of nocebo effects in RCT placebo groups, measured in terms of adverse events (AEs) and dropouts, will be presented as an explicative framework for the COVID-19 pandemic. Currently, SARS-CoV-2 vaccines are the only RCTs routinely conducted during the pandemic. Information about efficacy and safety of different vaccines represents a fertile ground for nocebo phenomena. Individual and contextual factors will be emphasized in order to understand the presence of a refusal of immunization associated with a specific vaccine considered less effective and safe. Critical aspects and some guidelines will be presented in order to counteract the nocebo effects and to improve adherence to drug treatments and the vaccination campaign.Expert opinion: The nocebo effect could explain the presence of strong resistance in European countries to immunization with a vaccine perceived as less effective, compared to others. Increased awareness of the nocebo effect would be relevant as it could lead to a greater participation in the vaccination campaign and in protecting individuals against SARS-CoV-2 infection.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/prevention & control , Nocebo Effect , Randomized Controlled Trials as Topic/methods , COVID-19 Vaccines/adverse effects , Europe , Humans , Medication Adherence , Patient Dropouts , Practice Guidelines as Topic , Vaccination Refusal/statistics & numerical data
8.
Trials ; 22(1): 62, 2021 Jan 18.
Article in English | MEDLINE | ID: covidwho-1067257

ABSTRACT

There is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.


Subject(s)
Academies and Institutes/organization & administration , COVID-19 , Clinical Trials as Topic/organization & administration , Administrative Personnel , Clinical Trials, Phase III as Topic , Communicable Disease Control , Communication , Data Collection , Hospitals, University , Humans , Ireland , Leadership , Patient Dropouts , Patient Selection , Personnel Staffing and Scheduling , Public Policy , Research Personnel , Research Subjects , SARS-CoV-2
9.
J Subst Abuse Treat ; 121: 108164, 2021 02.
Article in English | MEDLINE | ID: covidwho-952287

ABSTRACT

On March 16, 2020, Ukraine's Ministry of Health issued nonspecific interim guidance to continue enrolling patients in opioid agonist therapies (OAT) and transition existing patients to take-home dosing to reduce community COVID-19 transmission. Though the number of OAT patients increased modestly, the proportion receiving take-home dosing increased from 57.5% to 82.2%, which translates on average to 963,952 fewer clinic interactions annually (range: 728,652-1,016,895) and potentially 80,329 (range: 60,721-84,741) fewer hours of in-person clinical encounters. During the transition, narcologists (addiction specialists) expressed concerns about overdoses, the guidance contradicting existing legislation, and patient dropout, either from incarceration or inadequate public transportation. Though clinicians did observe some overdoses, short-term overall mortality remained similar to the previous year. As the country relaxes the interim guidance, we do not know to what extent governmental guidance or clinical practice will change to adopt the new guidance permanently or revert to pre-guidance regulations. Some future considerations that have come from COVID-19 are should dosing schedules continue to be flexible, should clinicians adopt telehealth, and should there be more overdose education and naloxone distribution? OAT delivery has improved and become more efficient, but clinicians should plan long-term should COVID-19 return in the near future. If the new efficiencies are maintained, it will free the workforce to further scale up OAT.


Subject(s)
Analgesics, Opioid/therapeutic use , Buprenorphine/therapeutic use , COVID-19/prevention & control , Methadone/therapeutic use , Opiate Substitution Treatment , Opioid-Related Disorders/rehabilitation , Drug Overdose , Humans , Patient Dropouts , Telemedicine , Ukraine
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