Methodology Review

Incentives and disincentives to participation by clinicians in randomised controlled trials

  1. Jennifer M Rendell1,*,
  2. Rowena K Merritt2,
  3. John Geddes2

Editorial Group: Cochrane Methodology Review Group

Published Online: 18 APR 2007

Assessed as up-to-date: 19 FEB 2007

DOI: 10.1002/14651858.MR000021.pub3


How to Cite

Rendell JM, Merritt RK, Geddes J. Incentives and disincentives to participation by clinicians in randomised controlled trials. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: MR000021. DOI: 10.1002/14651858.MR000021.pub3.

Author Information

  1. 1

    University of Oxford, Psychiatry, Oxford, UK

  2. 2

    University of Oxford, Department of Psychiatry, Oxford, UK

*Jennifer M Rendell, Psychiatry, University of Oxford, Department of Psychiatry, Warneford Hospital, Oxford, OX3 7JX, UK. jennifer.rendell@psych.ox.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 APR 2007

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Patients and clinicians need reliable, up-to-date information from randomised controlled trials (RCTs) on the costs and benefits of treatments. Recruitment difficulties arise when clinicians do not invite patients to participate in trials.

Objectives

Primary: to assess the evidence for the effect of disincentives and incentives on the extent to which clinicians invite eligible patients to participate in RCTs of healthcare interventions.
Secondary: to assess the evidence in relation to stated willingness to invite participation.

Search methods

1. The Cochrane Methodology Register and Cochrane Database of Methodology Reviews were searched in May 2006 and Cochrane Central Register of Controlled Trials, National Research Register and ClinicalTrialsGov in April 2005.
2. EMBASE, MEDLINE, CINAHL, PsycINFO and AMED were searched in April 2005.
3. Reference lists of included studies were checked.

Selection criteria

Studies exploring the effect of (dis)incentives on clinicians' views and recruitment-related activity.

Data collection and analysis

The information about included studies was insufficient for a full assessment of quality. Data on (dis)incentives were extracted and association with recruitment tested.

Main results

No RCTs of interventions were identified. Eleven observational studies were included - two medical records reviews, one matched pair study, one clinician interview study, two studies documenting clinicians' decisions and five postal surveys. Three measures of recruitment were used, invitation to participate, entry into RCT and reported entry to RCT. Five studies explored the effect of patient characteristics. The effect of age and prognosis varied between trials. Six studies considered the association between clinicians' views and recruitment. Clinicians who agreed to participate because they were acquainted with the researchers were less likely to participate than those otherwise motivated (1 study, 2-sided p = 0.04 Fisher's exact test) and (Odds Ratio [OR] 0.4, 95% Confidence Interval [CI] 0.2 to 0.9, 1 study). Clinicians who had recruited were more likely to report some difficulties including "trials involve extra work" (OR 92.94, 95% CI 4.54 - 1902.11; p ≤ 0.01, 1 study) and "inviting patients to participate is embarrassing" (chi-square 15.55, df = 1, p < 0.0001, 1 study). The effect of the need to discuss clinical uncertainty was unclear but concern that the doctor-patient relationship would be adversely affected by participation was a deterrent (chi-square = 7.25, df = 1, p = 0.007, 1 study).

Authors' conclusions

The impact of factors varied across studies. Researchers need to be aware that aspects of the design and conduct of trials can affect clinicians' willingness to invite patients to participate. Further research is needed.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Incentives and disincentives to participation by clinicians in randomised controlled trials

Randomised controlled trials (RCTs) are needed to provide robust evidence of the relative efficacy and safety of treatments. In many RCTs, clinicians (i.e. healthcare professionals inviting patients to take part in an RCT in which they provide at least one of the interventions) only invite a small proportion of the people who are eligible for trials to take part. Observational studies have been conducted to explore reasons for this but the results do not identify any factors that appear to have a consistent impact on recruitment.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

醫師造成之隨機對照試驗(RCTs)參與的誘因與反誘因

病人和醫師都渴望可靠新穎的治療成本效益的資訊﹐必須仰賴隨機對照試驗的研究結果。當醫師不邀請病人加入臨床試驗時,臨床試驗招募參與者的工作便會遭遇困難。

目標

首要:評估促成或不利醫師邀請病人加入醫療處置的隨機對照試驗的實證基礎。次要:評估證據和所記載的病人加入試驗之意願的關係。

搜尋策略

1. 2006年5月搜尋了The Cochrane Methodology Register and Cochrane Database of Methodology Reviews, 2005年4月搜尋了Cochrane Central Register of Controlled Trials, National Research Register and ClinicalTrialsGov 2. 2005年4月搜尋了EMBASE, MEDLINE, CINAHL, PsycINFO 與 AMED. 3. 檢查入選報告的參考文獻清單。

選擇標準

探討促成因素和不利因素對醫師的觀點及招募活動的影響。

資料收集與分析

入選的研究報告資訊不足﹐無法進行完整的品質評估。擷取促成因素和不利因素的資料﹐並測試與招募活動的關連。

主要結論

找不到關於此一主題的隨機臨床試驗﹐所以納入了11個觀察性研究──2個病歷回顧(medical records reviews),1個配對樣本研究(one matched pair study),1個醫師面談研究(clinician interview study),2個記錄醫師決定的研究,及5個郵寄問卷研究。共使用3種招募活動的指標:邀請加入人數、參加RCT人數及據報參加RCT人數。5個研究探討病人特徵之影響。年紀及疾病預後的效果視試驗而定。6個研究探討醫師觀點和招募活動之關連。因為認識研究者而加入的醫師﹐比較不會參與(一個研究,2sided p = 0.04 Fisher's exact test;Odds Ratio [OR] 0.4, 95% Confidence Interval [CI] 0.2 – 0.9)。曾經招募病人參與的醫師比較會報告一些困難,包括????「臨床試驗有額外的工作」(OR 92.94, 95% CI 4.54 − 1902.11; p? 0.01, 1 study),及「邀請病人加入很難為情」(chisquare 15.55, df = 1, p <0.0001, 一個研究)。必須和病人討論臨床上不確定性其效應並不清楚,但擔心醫病關係受到不良影響則有相當的負面效果。(chisquare = 7.25, df = 1, p = 0.007, 一個研究)。

作者結論

考慮因素的影響視研究而定。研究者應知﹐臨床試驗的設計和進行方式會影響醫師邀請病人參與的意願。此主題需進一步研究。

翻譯人

本摘要由慈濟醫院葉日弌翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

關於治療的有效及安全性可靠的證據,需依賴隨機臨床試驗提供。在許多隨機臨床試驗中,醫師只邀請一小部分合格受試者參與試驗。已有觀察性研究探詢此一現象的原因,但找不到影響招募的決定因素。