Journal of clinical epidemiology
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Randomized Controlled Trial Comparative Study
PROMIS 4-item measures and numeric rating scales efficiently assess SPADE symptoms compared with legacy measures.
The 5 SPADE (sleep, pain, anxiety, depression, and low energy/fatigue) symptoms are among the most prevalent and disabling symptoms in clinical practice. This study evaluates the minimally important difference (MID) of Patient-Reported Outcomes Measurement Information System (PROMIS) measures and their correspondence with other brief measures to assess SPADE symptoms. ⋯ A 2-step screening process for SPADE symptoms might use single-item NRS scores, proceeding to PROMIS scales for NRS scores ≥5. A PROMIS T-score change of three points represents a reasonable MID estimate, with two to four points approximating lower and upper bounds.
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Randomized Controlled Trial
A data-sharing agreement helps to increase researchers' willingness to share primary data: results from a randomized controlled trial.
Sharing individual participant data (IPD) among researchers, on request, is an ethical and responsible practice. Despite numerous calls for this practice to be standard, however, research indicates that primary study authors are often unwilling to share IPD, even for use in a meta-analysis. This study sought to examine researchers' reservations about data sharing and to evaluate the impact of sending a data-sharing agreement on researchers' attitudes toward sharing IPD. ⋯ These findings shed light on data-sharing practices, attitudes, and concerns and can be used to inform future meta-analysis projects seeking to collect IPD, as well as the field at large.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.
Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. ⋯ The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice.
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Randomized Controlled Trial
The agreement between proxy and self-completed EQ-5D for care home residents was better for index scores than individual domains.
Proxy measures are an alternative source of data for care home residents who are unable to complete the health utility measure, but the agreement levels between residents and care home staff for the EQ-5D have not been investigated previously. The objective of the present study was to examine the inter-rater agreement levels for the reporting of EQ-5D by care home residents and staff, adjusting for the impact of clustering. ⋯ Proxies appear to be an acceptable source of data for index scores and QALYs but may be less reliable if individual domains are considered.
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Randomized Controlled Trial
An advance letter did not increase the response rates in a telephone survey: a randomized trial.
To test the impact of an advance letter on response and cooperation rates in a nationwide telephone survey, given previous inconsistent results. ⋯ An advance letter was not seen to be effective in increasing response or cooperation rates in a nationwide telephone survey. Researchers should consider alternative methods of increasing participation in telephone surveys.