scholarly journals COVID-PCD – a participatory research study on the impact of COVID-19 in people with Primary Ciliary Dyskinesia

2020 ◽  
Author(s):  
Eva SL Pedersen ◽  
Eugénie NR Collaud ◽  
Rebeca Mozun ◽  
Cristina Ardura-Garcia ◽  
Yin Ting Lam ◽  
...  
Keyword(s):  
Support Groups ◽  
Social Contact ◽  
Epidemiological Data ◽  
Course Of Disease ◽  
Baseline Questionnaire ◽  
Study Results ◽  
Contact Behaviour ◽  
The Impact ◽  
Ciliary Dyskinesia

AbstractIntroductionCOVID-PCD is a participatory study initiated by people with PCD who have an essential vote in all stages of the research from the design of the study to the recruitment of participants, and interpretation and communication of the study results. COVID-PCD aims to collect epidemiological data in real time from people with PCD throughout the pandemic to describe incidence of COVID-19, symptoms, and course of disease; identify risk factors for prognosis; and assess experiences, wishes, and needs.MethodsThe study is advertised through patient support groups and participants register online on the study website (www.covid19pcd.ispm.ch). The study invites persons of any age from anywhere in the world with a suspected or confirmed PCD. A baseline questionnaire assesses details on PCD diagnosis, habitual symptoms, and COVID-19 episodes that occurred before study entry. Afterwards, participants receive a weekly follow-up questionnaire with questions on incident SARS-CoV-2 infections, current symptoms, social contact behaviour, and physical activity. Occasional thematic questionnaires are sent out focusing on emerging questions of interest chosen by people with PCD. In case of hospitalisation, patients or family members are asked to obtain a hospital report. Results are continuously analysed and summaries put online.ConclusionThe study started recruitment on April 30, 2020, and 556 people with PCD completed the baseline questionnaire by November 2, 2020. The COVID-PCD study is a participatory study that follows people with PCD during the COVID-19 pandemic, helps to empower affected persons, and serves as a platform for communication between patients, physicians, and researchers.

scholarly journals COVID-PCD – a participatory research study on the impact of COVID-19 in people with Primary Ciliary Dyskinesia

2020 ◽  
pp. 00843-2020
Author(s):  
Eva S. L. Pedersen ◽  
Eugénie N. R. Collaud ◽  
Rebeca Mozun ◽  
Cristina Ardura-Garcia ◽  
Yin Ting Lam ◽  
...  
Keyword(s):  
Support Groups ◽  
Social Contact ◽  
Epidemiological Data ◽  
Course Of Disease ◽  
Baseline Questionnaire ◽  
Study Results ◽  
Contact Behaviour ◽  
The Impact ◽  
Ciliary Dyskinesia

IntroductionCOVID-PCD is a participatory study initiated by people with PCD who have an essential vote in all stages of the research from the design of the study to the recruitment of participants, and interpretation and communication of the study results. COVID-PCD aims to collect epidemiological data in real time from people with PCD throughout the pandemic to describe incidence of COVID-19, symptoms, and course of disease; identify risk factors for prognosis; and assess experiences, wishes, and needs.MethodsThe study is advertised through patient support groups and participants register online on the study website (www.covid19pcd.ispm.ch). The study invites persons of any age from anywhere in the world with a suspected or confirmed PCD. A baseline questionnaire assesses details on PCD diagnosis, habitual symptoms, and COVID-19 episodes that occurred before study entry. Afterwards, participants receive a weekly follow-up questionnaire with questions on incident SARS-CoV-2 infections, current symptoms, social contact behaviour, and physical activity. Occasional thematic questionnaires are sent out focusing on emerging questions of interest chosen by people with PCD. In case of hospitalisation, patients or family members are asked to obtain a hospital report. Results are continuously analysed and summaries put online.ConclusionThe study started recruitment on April 30, 2020, and 556 people with PCD completed the baseline questionnaire by November 2, 2020. The COVID-PCD study is a participatory study that follows people with PCD during the COVID-19 pandemic, helps to empower affected persons, and serves as a platform for communication between patients, physicians, and researchers.

scholarly journals COVID-19 vaccinations: perceptions and behaviours in people with primary ciliary dyskinesia

2021 ◽  
Author(s):  
Eva Sophie Lunde Pedersen ◽  
Maria Christina Mallet ◽  
Yin Ting Lam ◽  
Sara Bellu ◽  
Isabelle Cizeau ◽  
...  
Keyword(s):  
Side Effects ◽  
Support Groups ◽  
Primary Ciliary Dyskinesia ◽  
Respiratory Infections ◽  
Public Information ◽  
Social Contact ◽  
Vaccine Uptake ◽  
Vaccination Uptake ◽  
Contact Behaviour ◽  
Ciliary Dyskinesia

Primary ciliary dyskinesia (PCD) is a rare genetic disease that causes recurrent respiratory infections. People with PCD may be at high risk of severe COVID-19 and vaccination against SARS-CoV-2 is therefore important. We studied vaccination willingness, speed of vaccination uptake, side effects, and changes in social contact behavior after vaccination in people with PCD. We used data from COVID-PCD, an international participatory cohort study. A questionnaire was e-mailed to participants in May 2021 that asked about COVID-19 vaccinations. 423 participants from 31 countries replied (median age: 30 years; 261 (62%) female). Vaccination uptake and willingness was high with 273 of 287 adults (96%) being vaccinated or willing to be in June 2021; only 4% were hesitant. The most common reasons for hesitancy were fear of side effects (reported by 88%). Mild side effects were common but no participant reported severe side effects. Half of participants changed their social contact behaviour after vaccination by seeing friends and family more often. The high vaccination willingness in the study population might reflect the extraordinary effort taken by PCD support groups to inform people about COVID-19 vaccination. Clear and specific public information and involvement of representatives is important for high vaccine uptake.

scholarly journals COVID-19 Vaccinations: Perceptions and Behaviours in People with Primary Ciliary Dyskinesia

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1496
Author(s):  
Eva S. L. Pedersen ◽  
Maria Christina Mallet ◽  
Yin Ting Lam ◽  
Sara Bellu ◽  
Isabelle Cizeau ◽  
...  
Keyword(s):  
Side Effects ◽  
Support Groups ◽  
Primary Ciliary Dyskinesia ◽  
Respiratory Infections ◽  
Social Contact ◽  
Vaccine Uptake ◽  
Specific Information ◽  
Vaccination Uptake ◽  
Contact Behaviour ◽  
Ciliary Dyskinesia

Primary ciliary dyskinesia (PCD) is a rare genetic disease that causes recurrent respiratory infections. People with PCD may be at higher risk of severe coronavirus disease 2019 (COVID-19), and therefore vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is important. We studied vaccination willingness, speed of vaccination uptake, side effects, and changes in social contact behaviour after vaccination in people with PCD. We used data from COVID-PCD, an international participatory cohort study. A COVID-19 vaccination questionnaire was emailed to participants in May 2021 and 423 participants from 31 countries replied (median age: 30 years, range 1–85 years; 261 (62%) female). Vaccination uptake and willingness were high, with 273 of 287 adults (96%) being vaccinated or willing to be in June 2021; only 4% were hesitant. The most common reason for hesitancy was fear of side effects, reported by 88%. Mild side effects were common, but no participant reported severe side effects. Half of the participants changed their social behaviour after vaccination by seeing friends and family more often. The high vaccination willingness in the study population might reflect the extraordinary effort taken by PCD support groups to inform people about COVID-19 vaccination. Clear and specific information and involvement of representatives is important for high vaccine uptake.

scholarly journals The influence of risk perceptions on close contact frequency during the SARS-CoV-2 pandemic

2021 ◽  
Author(s):  
James Wambua ◽  
Lisa Hermans ◽  
Pietro Coletti ◽  
Frederik Verelst ◽  
Lander Willem ◽  
...  
Keyword(s):  
Public Health ◽  
Health Communication ◽  
Risk Perceptions ◽  
Close Contact ◽  
Social Contact ◽  
Perceived Severity ◽  
Public Health Communication ◽  
Contact Behaviour ◽  
Contact Frequency ◽  
The Impact

Abstract Human behaviour is known to be crucial in the propagation of infectious diseases through respiratory or close-contact routes like the current SARS-CoV-2 virus. Intervention measures implemented to curb the spread of the virus mainly aim at limiting the number of close contacts, until vaccine roll-out is complete. Our main objective was to assess the relationships between SARS-CoV-2 perceptions and social contact behaviour in Belgium. Understanding these relationships is crucial to maximize interventions' effectiveness, e.g. by tailoring public health communication campaigns. In this study, we surveyed a representative sample of adults in Belgium in two longitudinal surveys (8 waves of survey 1 in April 2020 to August 2020, and 11 waves of survey 2 in November 2020 to April 2021). Generalized linear mixed effects models were used to analyse the two surveys. Participants with low and neutral perceptions on perceived severity made a significantly higher number of social contacts as compared to participants with high levels of perceived severity after controlling for other variables. Furthermore, participants with higher levels of perceived effectiveness of measures and perceived adherence to measures made fewer contacts. However, the differences were small. Our results highlight the key role of perceived severity on social contact behaviour during a pandemic. Nevertheless, additional research is required to investigate the impact of public health communication on severity of COVID-19 in terms of changes in social contact behaviour.

scholarly journals P–070 Evaluation of SARS-CoV–2 in human semen and effect on total sperm number: A prospective observational study

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
J Best ◽  
M Kuchakulla ◽  
K Khodamoradi ◽  
T Lima ◽  
F Frech ◽  
...  
Keyword(s):  
Semen Analysis ◽  
Epidemiological Data ◽  
Semen Parameters ◽  
Human Semen ◽  
Sperm Number ◽  
Rt Pcr ◽  
Sperm Analysis ◽  
Reproductive Techniques ◽  
The Impact

Abstract Study question Is the SARS-CoV–2 virus present in human semen and what is the impact on semen parameters following an infection? Summary answer SARS-CoV–2 infection, though not detected in semen of recovered men, can affect TSN in ejaculate in the acute setting. What is known already Early epidemiological data has suggested that the primary mode of transmission is through respiratory droplets, but the presence of SARS-CoV–2 has been identified in other bodily fluids such as feces, urine, and semen. Study design, size, duration We prospectively recruited thirty men diagnosed with acute SARS-CoV–2 infection using real-time reverse transcriptase-polymerase chain reaction (RT-PCR) of pharyngeal swab specimens. Thirty semen samples from recovered men were obtained 11–64 days after testing positive for SAR-CoV–2 infection. The median duration between positive SAR-CoV–2 test and semen collection was 37 days (IQR=23). Participants/materials, setting, methods Semen samples were collected from each individual using mailed kits. Follow-up semen samples were done with mailed kits or in-person in office setting. Semen analysis and PCR was performed after samples were received. Main results and the role of chance The median total sperm number (TSN) in ejaculate was 12.5 million (IQR=53.1). When compared with age-matched SARS-CoV–2(-) men, TSN was lower among SARS-CoV–2(+) men (p = 0.0024). Five men completed a follow-up sperm analysis (median 3 months) and had a median TSN of 18 million (IQR=21.6). No RNA was detected by means of RT-PCR in the semen in 16 samples tested. Limitations, reasons for caution First, most of the semen samples came from non-severe men of whom were in the recovery stage and lacked symptoms. Additionally, our sample size was relatively small and overnight mail-in semen analysis kits were used during the acute phase of infection to minimize contact with positive subjects. Wider implications of the findings: Our findings suggest extremely low risk of viral transmission during sexual contact and assisted reproductive techniques, although further data need to be obtained. The impact on TSC in recovered men from SARS-CoV–2 infection is concerning, nevertheless long-term follow-up of these men is critical to determine the nadir of TSC. Trial registration number 20200401

scholarly journals Body Composition in Community-Dwelling Older Adults Before and After SARS-CoV-2 Infection: A Longitudinal Prospective Study in a Rural Village Struck by the Pandemic

2021 ◽  
Vol 12 ◽  
pp. 215013272110477
Author(s):  
Oscar H. Del Brutto ◽  
Robertino M. Mera ◽  
Denisse A. Rumbea ◽  
Pedro Pérez ◽  
Bettsy Y. Recalde ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Body Composition ◽  
Regression Models ◽  
Community Dwelling ◽  
The Body ◽  
Study Results ◽  
The Impact ◽  
Community Dwelling Older Adults

Background: Information on the body composition of inhabitants of remote communities during the SARS-CoV-2 pandemic is limited. Using a longitudinal population-based study design, we assessed the association between SARS-CoV-2 infection and changes in body composition. Methods: Community-dwelling older adults living in a rural Ecuadorian village received body composition determinations before and 1 year after the pandemic as well as serological tests for detection of SARS-CoV-2 antibodies. The independent association between SARS-CoV-2 infection and abnormalities in body composition at follow-up was assessed by fitting linear mixed models for longitudinal data. Results: Of 327 enrolled individuals, 277 (85%) received baseline and follow-up body composition determinations, and 175 (63%) of them became SARS-CoV-2 seropositive. Overall, diet and physical activity deteriorated during the follow-up. Multivariate random-effects generalized least squares regression models that included the impact of time and seropositivity on follow-up body composition, showed that neither variable contributed to a worsening in body composition. Multivariate logistic regression models disclosed that the serological status at follow-up cannot be predicted by differences in body composition and other baseline covariates. Conclusions: Study results suggest no increased susceptibility to SARS-CoV-2 infection among older adults with abnormal body composition and no significant changes as a result of worse physical activity and dietary habits or seropositivity during the length of the study. Together with a previous study in the same population that showed decrease in hand-grip strength after SARS-CoV-2, results confirm that dynapenia (and not sarcopenia) is associated with SARS-CoV-2 infection in older adults.

A simulation study of loss to follow up: The impact on time to event and prevention.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14097-e14097
Author(s):  
Donna Elise Levy ◽  
Bingyan Wu ◽  
Daniel Quinn ◽  
Sophie Jentzsch ◽  
Christine Lusk ◽  
...  
Keyword(s):  
Treatment Options ◽  
Patient Treatment ◽  
Future Research ◽  
Time To Event ◽  
Loss To Follow Up ◽  
Study Results ◽  
Patient Attrition ◽  
The Impact ◽  
Future Patient

e14097 Background: Patient attrition during study follow up is a concern in all clinical trials, although its impact on study results has rarely been assessed. In oncology, in particular, where studies are lengthier and may be extended into longitudinal studies, there is an increased likelihood of loss to follow up (LTFU) (Gill et al., 2018). This creates a heightened need to understand how it affects the trial’s validity. The loss of data from patients who have been LTFU can reduce a study’s precision and power. This imprecision not only impacts the results of the current study but can also affect future research as well as future patient treatment options. Studies have found that participant characteristics differ in individuals LTFU as compared to those who remain in follow up (Childs et al., 2011; Geng et al., 2008; Hochheimer et al., 2016). This further emphasizes how attrition can skew study results and their interpretation and supports the need to minimize patient attrition during follow up in order to reduce bias and generate robust study estimates. Methods: This study assessed the impact of LTFU rates on the study estimates through simulations using SAS software. While all endpoints can be affected by LTFU, this study assessed time-to-event endpoints. Exponential distribution was assumed with varying rates of LTFU. In addition, the work covered suggestions for reducing LTFU. Results: Even for low rates of LTFU, biases are introduced in time-to event endpoints. Conclusions: Researchers should make every effort to minimize the extent of LTFU in the design and of and conduct of their trials.

Interim analysis of a phase 2 minimal residual disease (MRD)-adaptive trial of elotuzumab, carfilzomib, lenalidomide, and dexamethasone (Elo-KRd) for newly diagnosed multiple myeloma (MM).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8011-8011
Author(s):  
Benjamin Avi Derman ◽  
Jeffrey A. Zonder ◽  
Ankit J. Kansagra ◽  
David L. Grinblatt ◽  
Sunil Narula ◽  
...  
Keyword(s):  
Stem Cell ◽  
High Risk ◽  
Primary Endpoint ◽  
Adaptive Design ◽  
Cell Transplant ◽  
Phase 2 ◽  
Newly Diagnosed ◽  
Study Results ◽  
The Impact

8011 Background: The addition of a monoclonal antibody to triplet induction regimens in patients (pts) with MM with intent for autologous stem cell transplant (ASCT) has resulted in higher overall and deep response rates. In this study we are investigating the impact of the addition of Elo to KRd on complete response (CR) and/or MRD-negative rates in newly diagnosed MM regardless of transplant eligibility. Methods: Pts were enrolled from four MM Research Consortium sites into this phase 2 study. All patients receive 12 cycles of Elo-KRd in 28-day cycles: Elo per standard dosing, K 20/56/70 mg/m2 days 1, 8 and 15, R 25 mg days 1-21, and dexamethasone 40 mg days 1, 8, 15, 22. ASCT eligible candidates can undergo stem cell collection after cycle 4 and then resume treatment; pts who elect to proceed to ASCT are censored for response at that time. Pts MRD(-) (<10-5) by NGS after cycles 8 (C8) and 12 (C12) proceed to Elo-Rd until progression. Patients who convert from MRD(+) to MRD(-) between C8 and C12 receive an additional 6 cycles of Elo-KRd (total 18 cycles) followed by Elo-Rd, and pts MRD(+) after C12 receive an additional 12 cycles of Elo-KRd (total 24) followed by Elo-Rd. The primary endpoint of the study is sCR and/or MRD(-) rate after C8 E-KRd. MRD status was determined by ClonoSEQ next generation sequencing (NGS, <10-5) [Adaptive Biotechnologies]. An improvement in the sCR and/or MRD(-) rate by NGS from a historical 30% to 50% at the end of C8 will be considered promising. Results: 44 pts are enrolled, 39 of whom are evaluable for response (cutoff Jan 10 2021). Median age is 62 years (range 43-81, 23% age >70) and 23 (52%) have high-risk cytogenetic abnormalities (HRCA) including 13 (30%) with >2 high-risk abnormalities (6 pts unknown cytogenetics). 34/39 (87%) have MRD trackable by clonoSEQ. The rate of sCR and/or MRD(-) by NGS at the end of C8 is 19/33 (58%), meeting the statistical threshold for establishing efficacy (2 pts censored for elective ASCT before C8 and 4 pts receiving therapy but have not reached C8). With a median follow-up of 24 months, estimated 2-year progression free survival is 87% (100% for standard risk, 79% for HRCA) and estimated 2-year overall survival is 89% (82% for HRCA). No pt who was MRD(-) by NGS after C8 has progressed, including 6 pts with HRCA. Serious adverse events occurred in 30 pts (68%). 89% experienced treatment emergent AEs, the most common (>10%) of which was pneumonia (14%). One pt had grade 5 myocardial infarction. Conclusions: Elo-KRd demonstrates tolerability consistent with known toxicities of these agents and met the primary endpoint of sCR and/or MRD(-) of >50% after 8 cycles. With longer follow-up, the study results may validate that an MRD-adaptive design for de-escalation of therapy in MM can generate deep responses while reducing treatment exposure. Clinical trial information: NCT02969837.

Evolution and Sustainability of the Helping Hands Volunteer Program: Consumer Recovery and Mental Health Comparisons Six Years On

2006 ◽  
Vol 12 (2) ◽  
pp. 88-103 ◽  
Author(s):  
Frank P. Deane ◽  
Retta Andresen
Keyword(s):  
Mental Health ◽  
Support Groups ◽  
Social Contact ◽  
Service Utilisation ◽  
Cross Sectional ◽  
Volunteer Program ◽  
Mental Health Consumers ◽  
Volunteer Participation ◽  
Consumer Recovery

AbstractThe Helping Hands program commenced in 1999 and partners volunteers with mental health consumers for support and to increase social contact, recreational and friendship opportunities. The aim of the present study is to describe the evolution and sustainability of the program over the first 6 years. A description of consumers accessing the program using recovery-oriented measures and traditional measures of behavioural functioning is also provided. Service data was collected on the development of the program, service utilisation, volunteer participation and funding patterns. Cross-sectional measures of recovery and baseline and follow-up Health of the Nation Outcome Scales (HoNOS) were collected on 27 participants. Results showed that the Helping Hands program has evolved significantly since start-up with the development of numerous recreational, health and support groups and 48 active volunteers and 62 active clients. Consumer feedback indicates that the service increases the quality of life of participants considerably. Current clients showed less severe disability at referral than did the original group. There were improvements in the area of relationships on the HoNOS for those who had baseline and follow-up measures. The high volunteer participation rates and positive consumer outcomes represent significant value in return for the modest level of funding.

Fine-needle aspiration of pancreatic cystic lesions: A randomized study comparing standard and flexible needles with long-term follow-up.

Endoscopy ◽  
2020 ◽  
Author(s):  
Mohammad Al-Haddad ◽  
Michael B Wallace ◽  
William Brugge ◽  
Sundeep Lakhtakia ◽  
Zhaoshen Li ◽  
...  
Keyword(s):  
Diagnostic Accuracy ◽  
Fine Needle Aspiration ◽  
Needle Aspiration ◽  
Cystic Lesions ◽  
Fine Needle ◽  
Cyst Volume ◽  
Study Results ◽  
Consensus Diagnosis ◽  
The Impact

Abstract Background and study aims: Pancreatic cystic lesions (PCLs) are increasingly found on cross-sectional imaging, and a majority have low risk for malignancy. The added value of fine-needle aspiration (FNA) in risk stratification remains unclear. We evaluated the impact of 3 FNA needles on diagnostic accuracy, clinical management, and ability to accrue fluid for tumor markers. Patients and methods: A multicenter prospective trial randomized 250 patients with PCLs≥13mm to 19G Flex(2):19G(1):22G(1) needles with cross-over as repeated FNA procedures. Diagnostic accuracy established at 2-year follow-up with final diagnosis from surgical histopathology or consensus diagnosis by experts based sequentially on clinical presentation, imaging, and aspirate analysis in blinded review. Results: Patients enrolled (36% symptomatic) with PCLs in head (44%), body (28%), and tail (26%). Percentage of cyst volume aspiration is 78% [72%-84%] for 19G Flex, 74% [64%-84%] for 22G, and 73% [63%-83%] for19G (p=.84). Successful FNA was significantly higher for 19G Flex (89% [82%-94%]) and 22G (82% [70%-90%]) compared to 19G (75% [63%-85%]) (p=0.02). Repeated FNA was required more frequently in head/uncinate lesions than body and tail (p<.01). Diagnostic accuracy of cyst aspirate was 84% [73%-91%] against histopathology at 2-year follow-up (n=79), and 77% [70%-83%] against consensus diagnosis among non-resective cases (n=171). Related serious adverse events occurred in 1.2% [0.2%-3.5%] of patients. Conclusions: Our study results demonstrate a statistically significant difference among the three needles in overall success rate of aspiration, but not in percentage of cyst volume aspirated. Flexible needles may be particularly valuable in sampling cystic PCLs in head/uncinate of pancreas.

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