A protocol for a systematic review of non-randomised evaluations of strategies to increase participant retention to randomised controlled trials

Adel El Feky, Katie Gillies, Heidi Rebecca Gardner, Cynthia Fraser, Shaun Treweek

Research output: Contribution to journalArticle

4 Citations (Scopus)
8 Downloads (Pure)

Abstract

Background
Randomised control trials are regarded as the gold standard for evaluating the effectiveness and efficacy of healthcare interventions with thousands of trials published every year. Despite significant investment in infrastructure, a staggering number of clinical trials continue to face challenges with retention. Dropouts could lead to negative consequences—from lengthy delays to missing data that can undermine the results and integrity of the trial.

Summarising evidence from non-randomised evaluations of retention strategies could provide complementary information to randomised evaluations that could guide trialists to the most effective ways of increasing retention of participants in clinical trials.

Methods
The following electronic databases will be searched for relevant studies: EMBASE, MEDLINE, the Cochrane Controlled Trials Register, and Cochrane Methodology Register and the search will be limited to English-published studies during the last 10 years to increase relevance to current trials. Non-randomised studies (observational studies) including a comparison of two or more strategies to increase participant retention in randomised trials or comparing one or more strategies with no strategy will be included. The primary outcome will be the proportion of participants remained at the primary analysis as determined in each retention study.

Discussion
This review aims to gather and evaluate evidence on the effect of retention strategies examined in non-randomised studies. It is imperative to collect evidence from obseravational studies to infer whether or not these studies could be considered a practical way to complement or even replace a broadly favourable randomised design. If we find that non-randomised studies to be included in this review are of high quality with adequate control of biases, we will recommend to trialists and others not to rely exclusively on randomised studies and to give meticulous attention to the plentiful evidence that can be obtained from non-randomised studies. Should the results of this review suggest that evaluating retention strategies in observational studies provides insufficient evidence to trialists planning their retention strategies, we will be able to say that there is little point in conducting non-randomised studies and that they would do better to invest their time and resources in a randomised evaluation if possible. Where a non-randomised study design is chosen, the review authors will offer recommendations to trialists and others regarding how to ensure that these studies are conducted in a way that can minimise the risk of bias and increase confidence in the findings.
Original languageEnglish
Article number30
JournalSystematic reviews
Volume7
DOIs
Publication statusPublished - 20 Feb 2018

Fingerprint

Randomized Controlled Trials
Observational Studies
Clinical Trials
MEDLINE
Databases
Delivery of Health Care

Cite this

@article{b3f78b813c3c471bb3e5ffe274b0350c,
title = "A protocol for a systematic review of non-randomised evaluations of strategies to increase participant retention to randomised controlled trials",
abstract = "BackgroundRandomised control trials are regarded as the gold standard for evaluating the effectiveness and efficacy of healthcare interventions with thousands of trials published every year. Despite significant investment in infrastructure, a staggering number of clinical trials continue to face challenges with retention. Dropouts could lead to negative consequences—from lengthy delays to missing data that can undermine the results and integrity of the trial.Summarising evidence from non-randomised evaluations of retention strategies could provide complementary information to randomised evaluations that could guide trialists to the most effective ways of increasing retention of participants in clinical trials.MethodsThe following electronic databases will be searched for relevant studies: EMBASE, MEDLINE, the Cochrane Controlled Trials Register, and Cochrane Methodology Register and the search will be limited to English-published studies during the last 10 years to increase relevance to current trials. Non-randomised studies (observational studies) including a comparison of two or more strategies to increase participant retention in randomised trials or comparing one or more strategies with no strategy will be included. The primary outcome will be the proportion of participants remained at the primary analysis as determined in each retention study.DiscussionThis review aims to gather and evaluate evidence on the effect of retention strategies examined in non-randomised studies. It is imperative to collect evidence from obseravational studies to infer whether or not these studies could be considered a practical way to complement or even replace a broadly favourable randomised design. If we find that non-randomised studies to be included in this review are of high quality with adequate control of biases, we will recommend to trialists and others not to rely exclusively on randomised studies and to give meticulous attention to the plentiful evidence that can be obtained from non-randomised studies. Should the results of this review suggest that evaluating retention strategies in observational studies provides insufficient evidence to trialists planning their retention strategies, we will be able to say that there is little point in conducting non-randomised studies and that they would do better to invest their time and resources in a randomised evaluation if possible. Where a non-randomised study design is chosen, the review authors will offer recommendations to trialists and others regarding how to ensure that these studies are conducted in a way that can minimise the risk of bias and increase confidence in the findings.",
author = "{El Feky}, Adel and Katie Gillies and Gardner, {Heidi Rebecca} and Cynthia Fraser and Shaun Treweek",
note = "This work is part of AE’s PhD which is funded by the University of Aberdeen Elphinstone Scholarship. The Health Services Research Unit, University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Governoment Health Directorates. The funder had no role in the protocol development.",
year = "2018",
month = "2",
day = "20",
doi = "10.1186/s13643-018-0696-7",
language = "English",
volume = "7",
journal = "Systematic reviews",
issn = "2046-4053",
publisher = "BioMed Central",

}

TY - JOUR

T1 - A protocol for a systematic review of non-randomised evaluations of strategies to increase participant retention to randomised controlled trials

AU - El Feky, Adel

AU - Gillies, Katie

AU - Gardner, Heidi Rebecca

AU - Fraser, Cynthia

AU - Treweek, Shaun

N1 - This work is part of AE’s PhD which is funded by the University of Aberdeen Elphinstone Scholarship. The Health Services Research Unit, University of Aberdeen receives core funding from the Chief Scientist Office of the Scottish Governoment Health Directorates. The funder had no role in the protocol development.

PY - 2018/2/20

Y1 - 2018/2/20

N2 - BackgroundRandomised control trials are regarded as the gold standard for evaluating the effectiveness and efficacy of healthcare interventions with thousands of trials published every year. Despite significant investment in infrastructure, a staggering number of clinical trials continue to face challenges with retention. Dropouts could lead to negative consequences—from lengthy delays to missing data that can undermine the results and integrity of the trial.Summarising evidence from non-randomised evaluations of retention strategies could provide complementary information to randomised evaluations that could guide trialists to the most effective ways of increasing retention of participants in clinical trials.MethodsThe following electronic databases will be searched for relevant studies: EMBASE, MEDLINE, the Cochrane Controlled Trials Register, and Cochrane Methodology Register and the search will be limited to English-published studies during the last 10 years to increase relevance to current trials. Non-randomised studies (observational studies) including a comparison of two or more strategies to increase participant retention in randomised trials or comparing one or more strategies with no strategy will be included. The primary outcome will be the proportion of participants remained at the primary analysis as determined in each retention study.DiscussionThis review aims to gather and evaluate evidence on the effect of retention strategies examined in non-randomised studies. It is imperative to collect evidence from obseravational studies to infer whether or not these studies could be considered a practical way to complement or even replace a broadly favourable randomised design. If we find that non-randomised studies to be included in this review are of high quality with adequate control of biases, we will recommend to trialists and others not to rely exclusively on randomised studies and to give meticulous attention to the plentiful evidence that can be obtained from non-randomised studies. Should the results of this review suggest that evaluating retention strategies in observational studies provides insufficient evidence to trialists planning their retention strategies, we will be able to say that there is little point in conducting non-randomised studies and that they would do better to invest their time and resources in a randomised evaluation if possible. Where a non-randomised study design is chosen, the review authors will offer recommendations to trialists and others regarding how to ensure that these studies are conducted in a way that can minimise the risk of bias and increase confidence in the findings.

AB - BackgroundRandomised control trials are regarded as the gold standard for evaluating the effectiveness and efficacy of healthcare interventions with thousands of trials published every year. Despite significant investment in infrastructure, a staggering number of clinical trials continue to face challenges with retention. Dropouts could lead to negative consequences—from lengthy delays to missing data that can undermine the results and integrity of the trial.Summarising evidence from non-randomised evaluations of retention strategies could provide complementary information to randomised evaluations that could guide trialists to the most effective ways of increasing retention of participants in clinical trials.MethodsThe following electronic databases will be searched for relevant studies: EMBASE, MEDLINE, the Cochrane Controlled Trials Register, and Cochrane Methodology Register and the search will be limited to English-published studies during the last 10 years to increase relevance to current trials. Non-randomised studies (observational studies) including a comparison of two or more strategies to increase participant retention in randomised trials or comparing one or more strategies with no strategy will be included. The primary outcome will be the proportion of participants remained at the primary analysis as determined in each retention study.DiscussionThis review aims to gather and evaluate evidence on the effect of retention strategies examined in non-randomised studies. It is imperative to collect evidence from obseravational studies to infer whether or not these studies could be considered a practical way to complement or even replace a broadly favourable randomised design. If we find that non-randomised studies to be included in this review are of high quality with adequate control of biases, we will recommend to trialists and others not to rely exclusively on randomised studies and to give meticulous attention to the plentiful evidence that can be obtained from non-randomised studies. Should the results of this review suggest that evaluating retention strategies in observational studies provides insufficient evidence to trialists planning their retention strategies, we will be able to say that there is little point in conducting non-randomised studies and that they would do better to invest their time and resources in a randomised evaluation if possible. Where a non-randomised study design is chosen, the review authors will offer recommendations to trialists and others regarding how to ensure that these studies are conducted in a way that can minimise the risk of bias and increase confidence in the findings.

U2 - 10.1186/s13643-018-0696-7

DO - 10.1186/s13643-018-0696-7

M3 - Article

VL - 7

JO - Systematic reviews

JF - Systematic reviews

SN - 2046-4053

M1 - 30

ER -