Intervention Review

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Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures

  1. Paul Kinnersley1,*,
  2. Katie Phillips1,
  3. Katherine Savage1,
  4. Mark J Kelly2,
  5. Elinor Farrell1,
  6. Ben Morgan1,
  7. Robert Whistance3,
  8. Vicky Lewis4,
  9. Mala K Mann5,
  10. Bethan L Stephens1,
  11. Jane Blazeby6,
  12. Glyn Elwyn1,
  13. Adrian GK Edwards1

Editorial Group: Cochrane Consumers and Communication Group

Published Online: 6 JUL 2013

Assessed as up-to-date: 17 JUL 2012

DOI: 10.1002/14651858.CD009445.pub2

How to Cite

Kinnersley P, Phillips K, Savage K, Kelly MJ, Farrell E, Morgan B, Whistance R, Lewis V, Mann MK, Stephens BL, Blazeby J, Elwyn G, Edwards AGK. Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. Cochrane Database of Systematic Reviews 2013, Issue 7. Art. No.: CD009445. DOI: 10.1002/14651858.CD009445.pub2.

Author Information

  1. 1

    Cardiff University, Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff, Wales, UK

  2. 2

    Cardiff University, South East Wales Trials Unit, Institute of Translation, Innovation, Methodology and Engagement, Cardiff, Wales, UK

  3. 3

    University of Bristol, Academic Unit of Surgical Research, School of Social and Community Medicine, Bristol, UK

  4. 4

    Wales Deanery for Postgraduate Medical and Dental Education, Cardiff, Wales, UK

  5. 5

    Information Services, Cardiff University, Support Unit for Research Evidence (SURE), Cardiff, Wales, UK

  6. 6

    University of Bristol, Section of Healthcare Research, The School of Social and Community Medicine, Bristol, UK

*Paul Kinnersley, Cochrane Institute of Primary Care and Public Health, School of Medicine, Cardiff University, 3rd Floor, Neuadd Meirionnydd, Heath Park, Cardiff, Wales, CF14 4XN, UK.

Publication History

  1. Publication Status: New
  2. Published Online: 6 JUL 2013




  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論
  6. Laienverständliche Zusammenfassung


Achieving informed consent is a core clinical procedure and is required before any surgical or invasive procedure is undertaken.  However, it is a complex process which requires patients be provided with information which they can understand and retain, opportunity to consider their options, and to be able to express their opinions and ask questions.  There is evidence that at present some patients undergo procedures without informed consent being achieved.


To assess the effects on patients, clinicians and the healthcare system of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare treatments and procedures.

Search methods

We searched the following databases using keywords and medical subject headings: Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 5, 2012), MEDLINE (OvidSP) (1950 to July 2011), EMBASE (OvidSP) (1980 to July 2011) and PsycINFO (OvidSP) (1806 to July 2011). We applied no language or date restrictions within the search. We also searched reference lists of included studies.

Selection criteria

Randomised controlled trials and cluster randomised trials of interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures. We considered an intervention to be intended to promote informed consent when information delivery about the procedure was enhanced (either by providing more information or through, for example, using new written materials), or if more opportunity to consider or deliberate on the information was provided.

Data collection and analysis

Two authors assessed the search output independently to identify potentially-relevant studies, selected studies for inclusion, and extracted data. We conducted a narrative synthesis of the included trials, and meta-analyses of outcomes where there were sufficient data.

Main results

We included 65 randomised controlled trials from 12 countries involving patients undergoing a variety of procedures in hospitals. Nine thousand and twenty one patients were randomised and entered into these studies. Interventions used various designs and formats but the main data for results were from studies using written materials, audio-visual materials and decision aids. Some interventions were delivered before admission to hospital for the procedure while others were delivered on admission.

Only one study attempted to measure the primary outcome, which was informed consent as a unified concept, but this study was at high risk of bias.  More commonly, studies measured secondary outcomes which were individual components of informed consent such as knowledge, anxiety, and satisfaction with the consent process.  Important but less commonly-measured outcomes were deliberation, decisional conflict, uptake of procedures and length of consultation.

Meta-analyses showed statistically-significant improvements in knowledge when measured immediately after interventions (SMD 0.53 (95% CI 0.37 to 0.69) I2 73%), shortly afterwards (between 24 hours and 14 days) (SMD 0.68 (95% CI 0.42 to 0.93) I2 85%) and at a later date (15 days or more) (SMD 0.78 (95% CI 0.50 to 1.06) I2 82%). Satisfaction with decision making was also increased (SMD 2.25 (95% CI 1.36 to 3.15) I2 99%) and decisional conflict was reduced (SMD -1.80 (95% CI -3.46 to -0.14) I2 99%). No statistically-significant differences were found for generalised anxiety (SMD -0.11 (95% CI -0.35 to 0.13) I2 82%), anxiety with the consent process (SMD 0.01 (95% CI -0.21 to 0.23) I2 70%) and satisfaction with the consent process (SMD 0.12 (95% CI -0.09 to 0.32) I2 76%). Consultation length was increased in those studies with continuous data (mean increase 1.66 minutes (95% CI 0.82 to 2.50) I2 0%) and in the one study with non-parametric data (control 8.0 minutes versus intervention 11.9 minutes, interquartile range (IQR) of 4 to 11.9 and 7.2 to 15.0 respectively). There were limited data for other outcomes.

In general, sensitivity analyses removing studies at high risk of bias made little difference to the overall results. 

Authors' conclusions

Informed consent is an important ethical and practical part of patient care.  We have identified efforts by researchers to investigate interventions which seek to improve information delivery and consideration of information to enhance informed consent.  The interventions used consistently improve patient knowledge, an important prerequisite for informed consent.  This is encouraging and these measures could be widely employed although we are not able to say with confidence which types of interventions are preferable. Our results should be interpreted with caution due to the high levels of heterogeneity associated with many of the main analyses although we believe there is broad evidence of beneficial outcomes for patients with the pragmatic application of interventions. Only one study attempted to measure informed consent as a unified concept.


Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論
  6. Laienverständliche Zusammenfassung

Interventions to promote informed consent for patients undergoing surgical and other invasive healthcare procedures

Before patients have an operation or other invasive procedure (e.g. endoscopy) it is crucial for the healthcare professional to explain what the treatment involves, what alternatives exist and the risks and benefits of the different treatment options.  This process is known as ‘informed consent’ and aims to provide sufficient information to allow patients to understand their treatment options and to choose between them. 

Research suggests that when informed consent is obtained, the information provided by healthcare professionals is often unclear or insufficient, leading to misunderstanding, a worse treatment response and even litigation.  A number of interventions have been developed to improve the quality of information provided to patients, including written pamphlets, videos and websites.  It is unclear whether these interventions work in clinical practice. 

In this review we summarise studies of interventions designed to improve information delivery or to improve consideration of information for informed consent. 

We searched the scientific literature to identify randomised controlled trials (RCTs) of interventions designed to improve informed consent in clinical practice.  We wanted to determine primarily whether these interventions improved all components of ‘informed consent’ (understanding, deliberation and communication of decision).  Other individual outcomes of direct relevance to patients (e.g. recall/knowledge, understanding, satisfaction and anxiety), those related to healthcare professionals (e.g. ease of use of intervention, satisfaction) and system outcomes (e.g. cost, rates of procedural uptake) were also assessed. 

We included 65 studies involving a total of 9021 patients.  The studies varied according to the type of intervention, the procedure for which consent was sought, the clinical setting and the outcomes measured.  Most interventions were written or audio-visual.  Only one study assessed all the elements of informed consent, but the design was not robust; all other studies assessed only components of informed consent.  When the results of multiple studies were combined, we found that interventions improved knowledge of the planned procedure, immediately (up to 24 hours), in the short term (1 to 14 days) and the long term (more than 14 days).  Satisfaction with decision making was increased; decisional conflict was reduced; and consultation length may be increased. There were no differences between the intervention and control for the outcomes of generalised anxiety, and either anxiety or satisfaction associated with the consent process.

Limitations of the review include difficulties combining the results of studies due to variation in the procedures undergone by patients, the interventions used and outcomes measured.  This means that we are uncertain as to which specific interventions are most effective but pragmatic steps to improve information delivery and consideration of the information are likely to benefit patients.  



  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論
  6. Laienverständliche Zusammenfassung







我們以關鍵字和醫學標題表搜尋了以下資料庫:考科藍對照試驗中心註冊 (CENTRAL, The Cochrane Library, 2012年第5期), MEDLINE (OvidSP) (1950年至2011年7月), EMBASE (OvidSP) (1980年至2011年7月)和PsycINFO (OvidSP) (1806年至2011年7月)。我們的搜尋並沒有使用語言或日期限制。我們還搜尋納入研究的參考文獻。






我們納入了來自12個國家的65篇隨機對照試驗,包含了在醫院進行各種處置的病人。共有 9021位病人隨機分配入這些研究。介入措施使用了各種設計和格式,但結果的主要數據來自於使用書面資料、視聽資料和決策輔助的研究。有些介入是在入院做處置前就進行,而有些是在入院時才進行。


統合分析顯示統計上有顯著的知識增進,當介入後立即測量 (SMD 0.53 (95% CI 0.37 to 0.69) I2 73%),不久之後 (介於24小時和14天之間) (SMD 0.68 (95% CI 0.42 to 0.93) I2 85%),以及較晚的日子 (15天以上) (SMD 0.78 (95% CI 0.50 to 1.06) I2 82%)。決策滿意度也提高了 (SMD 2.25 (95% CI 1.36 to 3.15) I2 99%),而決策衝突減少了 (SMD -1.80 (95% CI -3.46 to -0.14) I2 99%)。統計上並無顯著差異於廣泛性焦慮 (SMD -0.11 (95% CI -0.35 to 0.13) I2 82%),同意過程的焦慮 (SMD 0.01 (95% CI -0.21 to 0.23) I2 70%),以及同意過程的滿意度 (SMD 0.12 (95% CI -0.09 to 0.32) I2 76%)。諮詢長度是增加的,在這些連續數據的研究中 (平均增加1.66分鐘 (95% CI 0.82 to 2.50) I2 0%),以及在1個非參數數據的研究中 (對照組8.0 分鐘與介入組11.9分鐘,四分位數間距 (IQR) 分別為4 to 11.9與 7.2 to 15.0)。其他的結果只有有限的數據。



知情同意是病人照護的一個重要的倫理和實際的部分。我們發現研究人員努力於調查介入措施力求改善資訊傳遞和資訊考慮,以增強知情同意。這些使用的介入措施一致地增進了病人的知識,此乃知情同意的重要前提。這是令人鼓舞的,這些措施可以廣泛地應用,雖然我們不夠有信心說這類型的介入措施是更好的。我們的研究結果應謹慎解讀,由於許多主要分析有著高度異質性,雖然我們相信有廣泛證據支持有利結果,對於病人實施介入措施的務實應用。只有 1 個研究試圖測量知情同意整體的概念。



  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論
  6. Laienverständliche Zusammenfassung






我們納入了65篇研究,共有 9021 位病人參與。研究是多樣化的,根據介入的形式,尋求同意的處置,臨床設置和測量結果。大多數的介入是書面或視聽資料。只有一個研究評估知情同意的所有元素,但其設計並不健全;其他研究則只評估知情同意的各個組成部分。當多個研究的結果合併起來,我們發現,介入措施增進了該計畫處置的知識,立即(最多24小時),短期(1至14天)和長期(多於14天)。決策的滿意度增加;決策衝突減少;諮詢長度可能增加。介入組和對照組之間沒有差異的結果,包括廣泛性焦慮,以及與同意過程有關的焦慮或滿意度。




本翻譯計畫由臺北醫學大學考科藍臺灣研究中心(Cochrane Taiwan)、台灣實證醫學學會及東亞考科藍聯盟(EACA)統籌執行


Laienverständliche Zusammenfassung

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要
  5. 淺顯易懂的口語結論
  6. Laienverständliche Zusammenfassung

Maßnahmen zur Förderung von Einverständniserklärung bei Patienten, welche sich chirurgischen oder anderen invasiven medizinischen Eingriffen unterziehen

Bevor Patienten sich einer Operation oder anderen invasiven Eingriffen (z. B. Endoskopie) unterziehen, ist es entscheidend, dass medizinisches Fachpersonal die Patienten aufklärt, was die Behandlung beinhaltet, welche Alternativen existieren und welche Risiken und Vorteile mit den anderen Behandlungsmöglichkeiten verbunden sind.  Dieser Prozess wird ‘Einverständniserklärung’ genannt und hat zum Ziel, ausreichende Informationen zu vermitteln, um es den Patienten zu ermöglichen, ihre Behandlungsoptionen zu verstehen und die für sie richtige Behandlung zu wählen. 

Bisherige Forschungsergebnisse deuten darauf hin, dass, wenn eine Einverständniserklärung eingeholt wurde, die vom medizinischen Fachpersonal vermittelten Informationen oft unklar oder unzureichend sind. Dies führt wiederum zu Missverständnissen, einer schlechteren Behandlungsreaktion und manchmal sogar zu Rechtsstreitigkeiten.  Um die Qualität der Patienten vermittelten Informationen, wie z. B. Broschüren, Videos und Websites, zu verbessern, wurde eine Reihe von Maßnahmen entwickelt.  Es ist jedoch noch unklar, ob diese Maßnahmen in der klinischen Praxis funktionieren. 

In diesem Review fassen wir Studien von Maßnahmen zusammen, die darauf abzielen, die Informationsübermittlung oder die Berücksichtigung von Information bei Einverständniserklärungen zu verbessern. 

Wir durchsuchten die wissenschaftliche Literatur nach randomisierten, kontrollierten Studien (RCTs) von Maßnahmen, die durchgeführt wurden, um die Einverständniserklärung in der klinischen Praxis zu verbessern.  Wir wollten vorrangig herausfinden, ob durch diese Maßnahmen alle Aspekte der ‘Einverständniserklärung’ (Verständnis, Beratung und Kommunikation der Entscheidung) verbessert wurden. Andere für Patienten unmittelbar relevante individuelle Endpunkte (z. B. Erinnerung/Wissen, Verständnis, Zufriedenheit und Angst) und solche, die sich auf das medizinische Fachpersonal (z. B. Vereinfachung der Anwendung von Maßnahmen, Zufriedenheit) und System (z. B. Kosten, prozedurale Aufnahmeraten) beziehen, wurden ebenfalls erfasst. 

Wir inkludierten 65 Studien mit insgesamt 9.021 Patienten.  Die Studien unterschieden sich je nach Art der Maßnahmen, der Eingriffe, für die ein Einverständnis eingeholt wurde, das klinische Umfeld und die gemessenen Endpunkte.  Die meisten Maßnahmen waren entweder schriftlich oder audiovisuell.  Es gab nur eine Studie, bei der alle Elemente  der Einverständniserklärung erfasst wurden, allerdings wies sie kein robustes Studiendesign auf. Alle anderen Studien bewerteten jeweils nur einzelne Komponenten der Einverständniserklärung.  Nach Zusammenfassen der Ergebnisse von mehreren Studien stellten wir fest, dass die Maßnahmen das Wissen über das geplante Verfahren unmittelbar (bis zu 24h), kurzfristig (1 bis 14 Tage) und langfristig (mehr als 14 Tage) verbessern konnten.  Die Zufriedenheit mit der Entscheidungsfindung wurde erhöht; Entscheidungskonflikte wurden reduziert, und die Beratungsdauer möglicherweise verlängert. Es gab keine Unterschiede zwischen der Interventions- und Kontrollgruppe bezüglich der Endpunkte generalisierte Angst, und Angst oder Zufriedenheit in Verbindung mit dem Einwilligungsprozess.

Zu den Einschränkungen dieses Reviews gehört die Schwierigkeit, die Ergebnisse der Studien zusammenzufassen. Diese Schwierigkeit ist auf Unterschiede hinsichtlich der Eingriffe, die bei den Patienten durchgeführt wurden, der angewandten Maßnahmen und der gemessenen Endpunkte zurückzuführen.  Es ist daher ungewiss, welche spezifischen Maßnahmen am wirksamsten sind. Pragmatische Schritte zur Verbesserung der Informationsübermittlung und der Berücksichtigung von Informationen sind jedoch für die Patienten wahrscheinlich von Nutzen. 

Anmerkungen zur Übersetzung

Koordination durch Cochrane Schweiz