Transitions from Telephone Surveys to Self-Administered and Mixed-Mode Surveys: AAPOR Task Force Report

Telephone surveys have been a ubiquitous method of collecting survey data, but the environment for telephone surveys is changing. Many surveys are transitioning from telephone to self-administration or combinations of modes for both recruitment and survey administration. Survey organizations are conducting these transitions from telephone to mixed modes with only limited guidance from existing empirical literature and best practices. This article summarizes findings by an AAPOR Task Force on how these transitions have occurred for surveys and research organizations in general. We find that transitions from a telephone to a selfadministered or mixed-mode survey are motivated by a desire to control costs, to maintain or improve data quality, or both. The most common mode to recruit respondents when transitioning is mail, but recent mixedmode studies use only web or mail and web together as survey administration modes. Although early studies found that telephone response rates met or exceeded response rates to the self-administered or mixed modes, after about 2013, response rates to the self-administered or mixed modes tended to exceed those for the telephone mode, largely because of a decline in the telephone mode response rates. Transitioning offers opportunities related to improved frame coverage and geographic targeting, delivery of incentives, visual design of an instrument, and cost savings, but challenges exist related to selecting a respondent within a household, length of a questionnaire, differences across modes in use of computerization to facilitate skip patterns and other questionnaire design features, and lack of an interviewer for respondent motivation and clarification. Other challenges related to surveying youth, conducting surveys in multiple languages, collecting nonsurvey data such as biomeasures or consent to link to administrative data, and estimation with multiple modes are also prominent

Remdesivir in adults with severe COVID-19:a randomised, double-blind, placebo-controlled, multicentre trial

Summary Background No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models. Methods We did a randomised, double-blind, placebo-controlled, multicentre trial at ten hospitals in Hubei, China. Eligible patients were adults (aged ≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection, with an interval from symptom onset to enrolment of 12 days or less, oxygen saturation of 94% or less on room air or a ratio of arterial oxygen partial pressure to fractional inspired oxygen of 300 mm Hg or less, and radiologically confirmed pneumonia. Patients were randomly assigned in a 2:1 ratio to intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or the same volume of placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir–ritonavir, interferons, and corticosteroids. The primary endpoint was time to clinical improvement up to day 28, defined as the time (in days) from randomisation to the point of a decline of two levels on a six-point ordinal scale of clinical status (from 1=discharged to 6=death) or discharged alive from hospital, whichever came first. Primary analysis was done in the intention-to-treat (ITT) population and safety analysis was done in all patients who started their assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04257656. Findings Between Feb 6, 2020, and March 12, 2020, 237 patients were enrolled and randomly assigned to a treatment group (158 to remdesivir and 79 to placebo); one patient in the placebo group who withdrew after randomisation was not included in the ITT population. Remdesivir use was not associated with a difference in time to clinical improvement (hazard ratio 1·23 [95% CI 0·87–1·75]). Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less (hazard ratio 1·52 [0·95–2·43]). Adverse events were reported in 102 (66%) of 155 remdesivir recipients versus 50 (64%) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12%) patients versus four (5%) patients who stopped placebo early. Interpretation In this study of adult patients admitted to hospital for severe COVID-19, remdesivir was not associated with statistically significant clinical benefits. However, the numerical reduction in time to clinical improvement in those treated earlier requires confirmation in larger studies

Molnupiravir versus placebo in unvaccinated and vaccinated patients with early SARS-CoV-2 infection in the UK (AGILE CST-2): a randomised, placebo-controlled, double-blind, phase 2 trial

Background The antiviral drug molnupiravir was licensed for treating at-risk patients with COVID-19 on the basis of data from unvaccinated adults. We aimed to evaluate the safety and virological efficacy of molnupiravir in vaccinated and unvaccinated individuals with COVID-19. Methods This randomised, placebo-controlled, double-blind, phase 2 trial (AGILE CST-2) was done at five National Institute for Health and Care Research sites in the UK. Eligible participants were adult (aged ≥18 years) outpatients with PCR-confirmed, mild-to-moderate SARS-CoV-2 infection who were within 5 days of symptom onset. Using permuted blocks (block size 2 or 4) and stratifying by site, participants were randomly assigned (1:1) to receive either molnupiravir (orally; 800 mg twice daily for 5 days) plus standard of care or matching placebo plus standard of care. The primary outcome was the time from randomisation to SARS-CoV-2 PCR negativity on nasopharyngeal swabs and was analysed by use of a Bayesian Cox proportional hazards model for estimating the probability of a superior virological response (hazard ratio [HR]>1) for molnupiravir versus placebo. Our primary model used a two-point prior based on equal prior probabilities (50%) that the HR was 1·0 or 1·5. We defined a priori that if the probability of a HR of more than 1 was more than 80% molnupiravir would be recommended for further testing. The primary outcome was analysed in the intention-to-treat population and safety was analysed in the safety population, comprising participants who had received at least one dose of allocated treatment. This trial is registered in ClinicalTrials.gov, NCT04746183, and the ISRCTN registry, ISRCTN27106947, and is ongoing. Findings Between Nov 18, 2020, and March 16, 2022, 1723 patients were assessed for eligibility, of whom 180 were randomly assigned to receive either molnupiravir (n=90) or placebo (n=90) and were included in the intention-to-treat analysis. 103 (57%) of 180 participants were female and 77 (43%) were male and 90 (50%) participants had received at least one dose of a COVID-19 vaccine. SARS-CoV-2 infections with the delta (B.1.617.2; 72 [40%] of 180), alpha (B.1.1.7; 37 [21%]), omicron (B.1.1.529; 38 [21%]), and EU1 (B.1.177; 28 [16%]) variants were represented. All 180 participants received at least one dose of treatment and four participants discontinued the study (one in the molnupiravir group and three in the placebo group). Participants in the molnupiravir group had a faster median time from randomisation to negative PCR (8 days [95% CI 8–9]) than participants in the placebo group (11 days [10–11]; HR 1·30, 95% credible interval 0·92–1·71; log-rank p=0·074). The probability of molnupiravir being superior to placebo (HR>1) was 75·4%, which was less than our threshold of 80%. 73 (81%) of 90 participants in the molnupiravir group and 68 (76%) of 90 participants in the placebo group had at least one adverse event by day 29. One participant in the molnupiravir group and three participants in the placebo group had an adverse event of a Common Terminology Criteria for Adverse Events grade 3 or higher severity. No participants died (due to any cause) during the trial. Interpretation We found molnupiravir to be well tolerated and, although our predefined threshold was not reached, we observed some evidence that molnupiravir has antiviral activity in vaccinated and unvaccinated individuals infected with a broad range of SARS-CoV-2 variants, although this evidence is not conclusive

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

Modeling predictors of latent classes in regression mixture models

The purpose of this study is to provide guidance on a process for including latent class predictors in regression mixture models. We first examine the performance of current practice for using the 1-step and 3-step approaches where the direct covariate effect on the outcome is omitted. None of the approaches show adequate estimates of model parameters. Given that Step 1 of the 3-step approach shows adequate results in class enumeration, we suggest using an alternative approach: (a) decide the number of latent classes without predictors of latent classes, and (b) bring the latent class predictors into the model with the inclusion of hypothesized direct covariate effects. Our simulations show that this approach leads to good estimates for all model parameters. The proposed approach is demonstrated by using empirical data to examine the differential effects of family resources on students’ academic achievement outcome. Implications of the study are discussed. Keywords: finite mixture model, including covariates, latent class predictor, regression mixture mode

Transitions from Telephone Surveys to Self-Administered and Mixed-Mode Surveys: AAPOR Task Force Report

Telephone surveys have been a ubiquitous method of collecting survey data, but the environment for telephone surveys is changing. Many surveys are transitioning from telephone to self-administration or combinations of modes for both recruitment and survey administration. Survey organizations are conducting these transitions from telephone to mixed modes with only limited guidance from existing empirical literature and best practices. This article summarizes findings by an AAPOR Task Force on how these transitions have occurred for surveys and research organizations in general. We find that transitions from a telephone to a selfadministered or mixed-mode survey are motivated by a desire to control costs, to maintain or improve data quality, or both. The most common mode to recruit respondents when transitioning is mail, but recent mixedmode studies use only web or mail and web together as survey administration modes. Although early studies found that telephone response rates met or exceeded response rates to the self-administered or mixed modes, after about 2013, response rates to the self-administered or mixed modes tended to exceed those for the telephone mode, largely because of a decline in the telephone mode response rates. Transitioning offers opportunities related to improved frame coverage and geographic targeting, delivery of incentives, visual design of an instrument, and cost savings, but challenges exist related to selecting a respondent within a household, length of a questionnaire, differences across modes in use of computerization to facilitate skip patterns and other questionnaire design features, and lack of an interviewer for respondent motivation and clarification. Other challenges related to surveying youth, conducting surveys in multiple languages, collecting nonsurvey data such as biomeasures or consent to link to administrative data, and estimation with multiple modes are also prominent

Thigh-length compression stockings and DVT after stroke

Controversy exists as to whether neoadjuvant chemotherapy improves survival in patients with invasive bladder cancer, despite randomised controlled trials of more than 3000 patients. We undertook a systematic review and meta-analysis to assess the effect of such treatment on survival in patients with this disease

Finite mixtures for simultaneously modelling differential effects and non-normal distributions

Regression mixture models have been increasingly applied in the social and behavioral sciences as a method for identifying differential effects of predictors on outcomes. Although the typical specification of this approach is sensitive to violations of distributional assumptions, alternative methods for capturing the number of differential effects have been shown to be robust. Yet, there is still a need to better describe differential effects that exist when using regression mixture models. This study tests a new approach that uses sets of classes (called differential effects sets) to simultaneously model differential effects and account for nonnormal error distributions. Monte Carlo simulations are used to examine the performance of the approach. The number of classes needed to represent departures from normality is shown to be dependent on the degree of skew. The use of differential effects sets reduced bias in parameter estimates. Applied analyses demonstrated the implementation of the approach for describing differential effects of parental health problems on adolescent body mass index using differential effects sets approach. Findings support the usefulness of the approach, which overcomes the limitations of previous approaches for handling nonnormal errors