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Intervention Protocol

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Diaries for recovery from critical illness

  1. Amanda J Ullman1,*,
  2. Leanne M Aitken1,2,
  3. Janice Rattray3,
  4. Justin Kenardy4,
  5. Robyne Le Brocque5,
  6. Stephen MacGillivray6,
  7. Alastair M Hull7

Editorial Group: Cochrane Anaesthesia Group

Published Online: 30 APR 2013

DOI: 10.1002/14651858.CD010468


How to Cite

Ullman AJ, Aitken LM, Rattray J, Kenardy J, Le Brocque R, MacGillivray S, Hull AM. Diaries for recovery from critical illness (Protocol). Cochrane Database of Systematic Reviews 2013, Issue 4. Art. No.: CD010468. DOI: 10.1002/14651858.CD010468.

Author Information

  1. 1

    Griffith University, NHMRC Centre of Research Excellence in Nursing, Centre for Health Practice Innovation, Griffith Health Institute, Brisbane, Queensland, Australia

  2. 2

    Princess Alexandra Hospital, Intensive Care Unit, Woolloongabba, Queensland, Australia

  3. 3

    University of Dundee, School of Nursing and Midwifery, Dundee, UK

  4. 4

    University of Queensland, School of Medicine, Herston, Queensland, Australia

  5. 5

    Mayne Medical School, The University of Queensland, Centre of National Research on Disability and Rehabilitation Medicine, Brisbane, Australia

  6. 6

    University of Dundee, Social Dimensions of Health Institute, Dundee, Tayside, UK

  7. 7

    NHS Tayside, Department of Psychiatry, Perth, UK

*Amanda J Ullman, NHMRC Centre of Research Excellence in Nursing, Centre for Health Practice Innovation, Griffith Health Institute, Griffith University, 170 Kessels Road, Brisbane, Queensland, 4111, Australia. a.ullman@griffith.edu.au.

Publication History

  1. Publication Status: New
  2. Published Online: 30 APR 2013

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This is not the most recent version of the article. View current version (09 DEC 2014)

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Description of the condition

Critical illness requiring admission to an intensive care unit (ICU) continues to increase in frequency around the world. As advances in health care are realized, more patients are surviving their stay in ICU but the implication of this is that there is an increase in the number of patients experiencing challenges during the recovery phase. During their ICU admission, patients experience extreme physical and psychological stressors including critical illness, delirium, fear, lack of privacy, noise, pain, sedation administration, sleep deprivation, and the abnormal ICU environment (Garrouste-Orgeas 2012; Kiekkas 2010; Merilaginen 2010). These experiences impact on a patient’s recovery from critical illness, which can be a complex and protracted process (Adamson 2004). Within this recovery period, patients may experience both physical (for example neuropathy, reduced mobility, and breathlessness) and psychological disorders (for example anxiety, depression and post-traumatic stress) (Cuthbertson 2007).

Psychological disorders, as well as anxiety and depression symptomatology, are commonly reported in patients and their caregivers after ICU admission. However, not every patient in ICU will develop psychological symptoms or a disorder; many individuals will be resistant or resilient to the ICU effects.  Many who show distress will return quickly to normal function and some with a psychological disorder will follow a recovery trajectory (Layne 2007). Cross sectional and cohort studies have reported anxiety and depression conditions in patients recovering from ICU admission at a higher rate than the general population, at between 24% and 45% at six weeks (Myhren 2009), three months (Sukantarat 2007) and one year (Rattray 2005) after ICU admission. Anxiety and depression conditions often co-exist with post-traumatic stress disorder (PTSD) (Samuelson 2007). PTSD is a serious disorder that follows the experience of a traumatic event and causes significant impairment in daily life (American Psychiatric Association 1994). The experience of the stressor generates feelings of intense fear, horror, helplessness, threat to life and physical integrity for the individual or someone to whom they have close affectional ties (American Psychiatric Association 1994). 

In addition to anxiety, depression and PTSD, ICU survivors have often reported the absence of factual memory and the occurrence of delusional memories, including hallucinations or nightmares, throughout their recovery period (Myhren 2009). ICU-related delusional memories are estimated to be present in around 30% to 70% of patients (Jones 2001; Ringdal 2009; Samuelson 2007), are often persecutory in nature, and tend to be recalled with high vividness and in substantial detail (Kiekkas 2010). The direct cause of these delusional memories is unknown but is thought to be related to a combination of medication (including adrenaline, corticosteroids, opiates, benzodiazepines and sedative drugs such as propofol), sleep deprivation, and critical illness (Jones 2001). The literature surrounding the relationship between recall of absent, traumatic or delusional memories and psychological disorders is mixed, with different authors finding positive (Jones 2001; Rattray 2010; Samuelson 2007; Schelling 2003) and negative associations (Granja 2008; Myhren 2009). The association between delusional memories and the psychological distress of ICU survivors has been mainly attributed to the strong vividness with long duration and high emotional content of these memories when compared with memories of real events (Ringdal 2009).

Research is now focusing on improving the long-term holistic health outcomes of ICU survivors. Psychological distress, including anxiety, depression and PTSD symptomatology, compromises the recovery of ICU survivors and has been increasingly identified as a serious problem. The challenge lies with clinicians and researchers to develop strategies to effectively manage and treat this psychological distress alongside and following life-saving physical treatment to maximise a patient's recovery.

 

Description of the intervention

One strategy that has been developed and implemented by clinical staff to treat the psychological distress prevalent in ICU survivors is patient diaries. Patient diaries provide a record of events which occur throughout a patient’s admission to the ICU. Following a time-line design, they provide a background to the cause of the patient’s ICU admission and an on-going narrative outlining day-to-day activities. Diversity of practice exists throughout ICUs in implementing patient diaries, including variation in structural, content and process elements.

Emerging in Scandinavia in the 1970s to 1980s (Egerod 2011a), multiple authors have outlined the introduction and evaluation of patient diaries both within their local ICUs and internationally. Patient diaries are generally written prospectively and addressed personally to the individual patient. ICU staff provide an overall structure for the diary, with a cover and sometimes a preprinted introduction and glossary of terms and equipment (Akerman 2010; Egerod 2007; Egerod 2011b). Diaries are generally structured with a summary outlining the reason and event of admission to ICU, daily entries, and a final note on discharge or transfer from the ICU (Egerod 2007).

Primary authorship is predominantly the responsibility of the bedside ICU nurse. Some ICUs encourage the participation of the patient’s family, reporting the diaries as a potential focus for family empowerment and family-centred care (Hale 2010; Roulin 2007). Current practice surrounding the provision of patient diaries to the patients is variable. ICUs differ between putting the diaries on the end of the bed when transferring a patient out of ICU to delivering a coordinated system of follow-up and support for the patients and their families (Akerman 2010; Egerod 2007; Roulin 2007).

 

How the intervention might work

Personal diaries are used by individuals to reflect on significant aspects of their lives and serve as a vehicle for construction, reconstruction and narration of stories (Egerod 2009). Patient diaries differ from personal diaries in that they are not first-person accounts. Nurses, hospital staff, family or friends vicariously write for the patient while the patient is unable to write due to altered state of consciousness, weakness or physical impairment (Egerod 2009).

Patients’ perceptions of intensive care are variable, often with very little or indeed nothing at all being remembered (Rattray 2010). For many patients their memories are unpleasant, fragmentary or frightening in nature (Rattray 2010). The aim of patient diaries is to provide ICU survivors with an accurate and informative collection of events, improving the memory recall of factual information. Delusional memories have been associated with anxiety, depression, post-traumatic stress symptomatology (Jones 2001; Rattray 2005) and poor health-related quality of life (Granja 2008). The aim of a diary is to provide a coherent narrative of the illness period, clarifying gaps in memory and diminishing the impact or dominance of imagined occurrences and hallucinations (Egerod 2011a). It has also been suggested that diaries can be used by relatives to encourage the healing process, after their own vicarious traumatic experience or as a basis for discussion about the patient’s illness experience (Egerod 2011a).

In comparison to this therapeutic view on patient diaries, there is however considerable concern regarding the method of providing this information and their use to reflect and reconstruct memories, thereby acting as a debriefing tool. Debriefing is a psychological treatment intended to reduce the psychological morbidity that arises after exposure to trauma (Rose 2002). It involves promoting some form of emotional process, catharsis or ventilation by encouraging recollection, ventilation or reworking of the traumatic event (Rose 2002). Since the 1990s debriefing has come under intense scrutiny, and a Cochrane review in 2002 (Rose 2002) found no evidence that single session individual psychological debriefing interventions prevented the onset of PTSD or reduced psychological distress. In addition to the lack of evidence, the majority of criticism is levelled at the timing of the debriefing, suggesting that during the immediate period after stress there is a substantial risk of causing retraumatization and inhibiting the individuals’ ability to normally process the traumatic event (Bledsoe 2002). Providing sensitive and private information without a supportive process could potentially cause significant psychological harm, negatively impacting a patient’s recovery.

 

Why it is important to do this review

Annual estimates suggest that more than 20 million patients require treatment in ICUs worldwide in order to manage critical illnesses, injuries or exacerbations of chronic conditions (Adhikari 2011). The combined after-effects of critical illness and the ICU experience have been linked to short and long-term psychological compromise, which can significantly impair psychological and physical patient recovery (Garrouste-Orgeas 2012; Kiekkas 2010). This results in a significant emotional, physical and financial burden to patients, families and society. Clinicians have developed and used patient diaries as a tool to treat psychological distress. However, it has not been established whether this is an effective practice or whether it may have an adverse psychological impact due to individual patient factors, author emphasis, or the method of feedback support or lack thereof.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

The objective of this review is to assess the effect of patient diaries on recovery, in comparison to standard ICU treatment, in patients recuperating from admission to an ICU and their caregivers or families.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Criteria for considering studies for this review

 

Types of studies

We will include all randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that have evaluated the effectiveness of patient diaries for their impact on recovery after admission to ICU. CCTs refer to quasi-randomized studies where although the trial involves testing an intervention and control, concurrent enrolment and follow-up of intervention and control-treated groups, the method of allocation is not considered strictly random (see Box 6.3a, Lefebvre 2011). We will include studies irrespective of publication status, year of publication or language. We will exclude non-randomized studies such as cohort studies because of the increased potential for bias. We will also exclude cross-over trials as this methodology is not suitable for evaluating an intervention that must be given at a specific time point.

 

Types of participants

We will include all patients who are admitted to an ICU and their family members or caregivers. The characteristics describing family members and caregiver participants will be defined by the study investigators. We will include patients irrespective of age, country and critical illness severity.

 

Types of interventions

The primary intervention under investigation is patient diaries provided by an ICU. We will include any RCT or CCT in which the presence or absence of patient diaries is the only difference between treatment groups. For the purpose of this review, patient diaries are defined as a prospectively written collection of events which occur during the ICU stay, authored by staff or relatives, or both (Garrouste-Orgeas 2012; Nydahl 2010).

 

Types of outcome measures

 

Primary outcomes

  1. Risk of post-traumatic stress disorder (PTSD) in patients recovering from admission to ICU, as assessed using a structured clinical interview (American Psychiatric Association 1994).
  2. Risk of anxiety in patients recovering from admission to ICU, as assessed using a tool with established reliability and validity such as the Hospital Anxiety and Depression Scale (HADS) (Zigmond 1983).
  3. Risk of depression in patients recovering from admission to ICU, as assessed using a tool with established reliability and validity such as the HADS (Zigmond 1983).

 

Secondary outcomes

  1. Risk of memory recall of ICU in patients recovering from admission to ICU, as assessed using a tool with established reliability and validity such as the Intensive Care Unit Memory Tool (ICU-MT) (Jones 2000).
  2. Post-traumatic stress symptomatology in patients recovering from admission to ICU, as assessed using a tool with established reliability and validity such as the post-traumatic stress disorder-related symptoms screening tool (PTSS–14) (Twigg 2008).
  3. Post-traumatic stress symptomatology in caregivers or family members of patients recovering from admission to ICU, as assessed using a tool with established reliability and validity such as the PTSS–14 (Twigg 2008).
  4. Risk of anxiety in caregivers or family members of patients recovering from admission to ICU, as assessed using a tool with established reliability and validity such as the HADS (Zigmond 1983).
  5. Risk of depression in caregivers or family members of patients recovering from admission to ICU, as assessed using a tool with established reliability and validity such as the HADS (Zigmond 1983).
  6. Carer or family member satisfaction, as described by the study investigator.
  7. Health-related quality of life in patients recovering from admission to ICU, as assessed using a tool with established reliability and validity.
  8. Costs, as described by the study investigator; including implementation and healthcare utilization costs.

 

Search methods for identification of studies

 

Electronic searches

We will search:

  • the Cochrane Anaesthetic Group (CARG) Trials Register (latest update);
  • the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (latest issue);
  • Ovid MEDLINE (1950 to present);
  • Ovid EMBASE (1980 to present);
  • PsycINFO (1950 to present);
  • Published International Literature on Traumatic Stress (PILOTS) database (1971 to present);
  • EBSCOhost CINAHL (1982 to present); and
  • Web of Science Conference Proceedings Citation Index - Science and Social Science and Humanities (1990 to present).

The search strategy which is detailed in Appendix 1 will be adapted to search the Cochrane Anaesthetic Group Trials Register, CENTRAL, Ovid MEDLINE, Ovid EMBASE and EBSCOhost CINAHL. We will combine the Ovid MEDLINE search with the Cochrane highly sensitive search strategy for identifying randomized trials in MEDLINE and EMBASE: the sensitivity and precision-maximizing version (2008 revision) (Lefebvre 2011). There will be no restrictions on the basis of date, language or publication status. We will also search the following clinical trial registers:

 

Searching other resources

We will handsearch bibliographies of all retrieved and relevant publications identified by these strategies for further studies. We will contact experts in the field to ask for information relevant to this review.

 

Data collection and analysis

 

Selection of studies

We will combine the results of the searches and exclude duplicate records. Two review authors (AU and LA) will independently assess titles and abstracts of retrieved studies for relevance. After this initial assessment we will retrieve full versions of all potentially eligible studies. The same two review authors will then independently check the full papers for eligibility. We will resolve discrepancies between review authors through mutual discussion and, where required, consult a third independent review author (RB). For transparency we will publish a summary of the selection of studies, including excluded studies and reasons for exclusion, using the PRISMA flowchart (Liberati 2009).

 

Data extraction and management

We will extract the details from eligible studies and summarize them using a data extraction sheet (see Appendix 2). The data extraction sheet has been developed in conjunction with the CARG. We will pilot test the form for the first two studies. Two review authors (AU and LA) will extract data independently and then cross check for accuracy and agreement. We will resolve, where necessary, any discrepancies though discussion and arbitration with a third review author (RB). We will include studies that have been published in duplicate once only. If there are any missing data from the papers then we will make attempts to contact study authors to retrieve missing information. See Appendix 2 for more information regarding the data to be extracted.

 

Assessment of risk of bias in included studies

Two authors (AU and LA) will independently assess each eligible study for quality and bias using the ‘Risk of bias assessment tool’ described in Chapter 8 of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We will resolve disagreements by discussion and if we cannot reach a consensus a third author (RB) will arbitrate. The bias tool addresses six specific domains, namely sequence generation, allocation and concealment, blinding, incomplete outcome data, selective outcome reporting, and other issues which may potentially bias the study (Higgins 2011). We will express judgements as ‘low risk’, ‘high risk’, or ‘unclear risk’ of bias. We will conduct sensitivity analyses to determine whether excluding studies at high risk of bias affects the results of the meta-analysis. We will report the ’Risk of bias’ table as part of the table ‘Characteristics of included studies’ and present a ’Risk of bias summary’ figure which will detail all of the judgements made for all included studies.

 

Measures of treatment effect

For dichotomous outcomes, we will calculate the risk ratio (RR) plus 95% confidence interval (CI). For continuous outcomes, we will calculate the mean difference (MD) plus 95% confidence interval. It is likely that different tools may be used to measure the same outcome (for example PTSD, anxiety). We will collect data only from those studies where scales have been validated and are self-reported or completed by an independent rater or relative (not the investigator). We will use the standardized mean difference (SMD) as the summary statistic in any meta-analysis of such data.

 

Unit of analysis issues

We do not predict any unit of analysis issues. It is expected the patient, family member or caregiver will be the unit of analysis for all RCTs or CCTs.

 

Dealing with missing data

We will, whenever possible, contact the original investigators to request missing data. If the data are not retrievable, we will make explicit the assumptions of methods used to cope with missing data. That is, if the data are assumed to be missing at random we will analyse only the available data; but if missing values are assumed to have a particular value we will detail the method used to assign the value. Additionally, if missing data are evident, we will perform a sensitivity analysis to assess how sensitive results are to reasonable changes in the assumptions that are made, and we will address the potential impact of missing data on the findings of the review in the discussion section.

 

Assessment of heterogeneity

We will consider clinical, methodological and statistical heterogeneity. We will undertake an assessment of the comparability of the studies prior to meta-analysis. If appropriate, we will pool data using meta-analysis with RevMan 5.1. Due to the predicted clinical heterogeneity, we will use a random-effects model. We will investigate the degree of statistical heterogeneity, that is the variation between the true intervention effects underlying the different studies, by a combination of methods (Higgins 2002). This involves visual inspection of the meta-analytic model and interpretation of the Chi2 and I2 statistics, which examine the total variance across studies due to heterogeneity rather than chance (Higgins 2003). If significant levels of heterogeneity are identified using these criteria, we will explore the heterogeneity and consider not undertaking a meta-analysis.

 

Assessment of reporting biases

We will report each outcome separately. We will use funnel plots to assess reporting biases if there are at least 10 studies included (Sterne 2011). We will undertake an observation of small-study effects assessment if required.

 

Data synthesis

Initially we will conduct a structured narrative summary of the studies reviewed. We will enter quantitative data into RevMan 5.1 and analyse the data using the RevMan analysis software. If the results are clinically heterogeneous, studies will be meta-analysed using both the fixed-effect model and random-effects model and we will explore any differences between these two estimates.

 

Subgroup analysis and investigation of heterogeneity

We do not predict any subgroup analysis for this review.

 

Sensitivity analysis

We will perform sensitivity analyses to exclude trials at high risk of bias, such as quasi-randomized trials. We will compare random-effects model and fixed-effect model estimates of each outcome variable.

 

Summary of findings    [Explanations]

We will use the principles of the GRADE system (Guyatt 2008) to assess the quality of the body of evidence associated with specific outcomes: incidence of PTSD in patients recovering from admission to ICU; incidence of anxiety in patients recovering from admission to ICU; incidence of depression in patients recovering from admission to ICU; incidence of memory recall of ICU in patients recovering from admission to ICU; post-traumatic stress symptomatology in patients recovering from admission to ICU; and post-traumatic stress symptomatology in caregivers or family members of patients recovering from admission to ICU in our review and construct a 'Summary of findings' (SoF) table using the GRADE software. The GRADE approach appraises the quality of a body of evidence based on the extent to which one can be confident that an estimate of effect or association reflects the item being assessed. The quality of a body of evidence considers within study risk of bias (methodologic quality), the directness of the evidence, heterogeneity of the data, precision of effect estimates and risk of publication bias.

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

We thank Jane Cracknell (Managing Editor, Cochrane Anaesthesia Review Group) and Karen Hovhannisyan (Trials Search Co-ordinator, Cochrane Anaesthesia Review Group) for their assistance in the preparation of this protocol. We would also like to thank Mathew Zacharias (content editor); Nathan Pace (statistical editor); Louise Rose, Ingrid Egerod and Megan Prictor (peer reviewers) for their help and editorial advice during the preparation of this protocol for the systematic review.

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Appendix 1. MEDLINE (OvidSP) search strategy

1. ((patient* or caregiver*) adj5 (diaries or diary or (narrat* adj3 (coherent or outlining)))).af. or ((exp Patients/ or exp Caregivers/) and exp Narration/)
2. ((critical* adj3 ill*) or ((intensive care unit* or ICU) adj5 (recover* or delusional memor* or psychological distress or anxiety or depression or PTSD or bedside nurs* or family or caregiver* or recuperate*))).af. or exp Intensive Care Units/ or exp Critical Care/ or exp Critical Illness/
3. 1 and 2

 

Appendix 2. Data extraction form

 

CARG

 

Data collection form

Intervention review – RCTs only

 


Review title or ID

     



 


Study ID (surname of first author and year first full report of study was published e.g. Smith 2001)

     



 


Report IDs of other reports of this study (e.g. duplicate publications, follow-up studies)

     



 


Notes:        

 

 



 

 

1.     General Information

 


Date form completed (dd/mm/yyyy)     

Name/ID of person extracting data     

 

Report title

(title of paper/ abstract/ report that data are extracted from)
     

 

Report ID

(ID for this paper/ abstract/ report)
     

 

Reference details

 
     

 

 

Report author contact details     

 

Publication type

(e.g. full report, abstract, letter)
     

 

Study funding sources

(including role of funders)
     

 

Possible conflicts of interest

(for study authors)
     

 

Notes:      

 

 



 

 

2.     Study Eligibility

 


Study CharacteristicsEligibility criteria

 
YesNoUnclearLocation in text

(pg & ¶/fig/table)






Type of studyRandomized Controlled Trial     





Controlled Clinical Trial

(quasi-randomized trial)
     






Participants

 
Patient’s or family members/ carers recovering from admission to an ICU

 
     






Types of interventionProspective patient diaries

 

 
     






Types of outcome measures
  • Incidence of PTSD: as assessed using a tool with established reliability and validity such as PTSS – 10


 
     




  • Incidence of anxiety: as assessed using a tool with established reliability and validity such as HADS.


 




  • Incidence of depression: as assessed using a tool with established reliability and validity such as HADS.


 




  • Incidence of accurate memory recall of ICU: as assessed using a tool with established reliability and validity such as ICU-MT.


 




  • Carer/ family member satisfaction: as described by the study investigator


 




  • Health-related quality of life in patients recovering from admission to ICU: as assessed using a tool with established reliability and validity


 




  • Costs


 






INCLUDE EXCLUDE 


Reason for exclusion

 
     


Notes:        

 

 




 

DO NOT PROCEED IF STUDY EXCLUDED FROM REVIEW

 

3.     Population and setting

 


 Description

Include comparative information for each group (i.e. intervention and controls) if available
Location in text

(pg & ¶/fig/table)



Population description

(from which study participants are drawn)
          



Setting

(including location and social context)
          



Inclusion criteria          



Exclusion criteria          



Method/s of recruitment of participants          



Informed consent obtained

 
          

Yes     No    Unclear
          

Notes:        

 

 




 

 

4.     Methods

 


 Descriptions as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Aim of study

 

 
          



Design (e.g. parallel, crossover, cluster)          



Unit of allocation

(by individuals, cluster/ groups or body parts)
          



Start date

 
     

 
     



End date

 
     

 
     



Total study duration

 
          



Ethical approval needed/ obtained for study          

Yes     No    Unclear
          

Notes:        

 

 




 

 

5.     Risk of Bias assessment

See Chapter 8 of the Cochrane Handbook

 


DomainRisk of bias

 
Support for judgement

 
Location in text

(pg & ¶/fig/table)

Low riskHigh riskUnclear

Random sequence generation

(selection bias)
          

Allocation concealment

(selection bias)

 
          

Blinding of participants and personnel

(performance bias)
Outcome group: All/     

     
     

(if required)Outcome group:      

     
     

Blinding of outcome assessment

(detection bias)
Outcome group: All/     

     
     

(if required)Outcome group:      

     
     

Incomplete outcome data

(attrition bias)

 
          

Selective outcome reporting?

(reporting bias)
          

Other bias

 

 
          

Notes:        

 

 



 

 

6.     Participants

Provide overall data and, if available, comparative data for each intervention or comparison group.

 


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)

Total no. randomized

(or total pop. at start of study for NRCTs)
          

Baseline imbalances          

Withdrawals and exclusions

(if not provided below by outcome)
          

Age          

Sex          

Race/Ethnicity          

Severity of illness          

Co-morbidities

 
          

Other treatment received (additional to study intervention)          

Other relevant sociodemographics

 
          

Subgroups measured

 
          

Subgroups reported

 
          

Notes:        

 

 



 

 

 

7.     Intervention groups

Copy and paste table for each intervention and comparison group

 

Intervention Group


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)

Group name

 
          

No. randomized to group

 
          

General content of diary

 
          

Author/s of diary          

Inclusion of photographs          

Method of providing the diary to the patient / family (including staff present, co-interventions at that time)          

Timing of providing the diary to the patient / family          

Other co-interventions (including follow-up)

 
          

Economic variables          

Resource requirements to replicate intervention

 
          

Notes:        

 

 



 

Comparison Group


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)

Group name

 
          

No. randomized to group

 
          

Description of standard ICU care received (e.g.. Follow-up)

 
          

Co-interventions

 
          

Economic variables          

Resource requirements to replicate intervention

 
          

Notes:        

 

 



 

 

8.     Outcomes

Copy and paste table for each outcome.

 

Outcome 1


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Outcome name

 
          



Time points measured          



Time points reported          



Outcome definition (with diagnostic criteria if relevant)          



Person measuring/reporting          



Unit of measurement

(if relevant)

 
          



Scales: upper and lower limits (indicate whether high  or low score is good)          



Is outcome/tool validated?          

Yes     No    Unclear
          

Imputation of missing data
(e.g. assumptions made for ITT analysis)
          



Assumed risk estimate

(e.g. baseline or population risk noted  in Background)
          



Power          



Notes:        

 

 




  

 

9.     Results

Copy and paste the appropriate table for each outcome, including additional tables for each time point and subgroup as required.

 

Dichotomous outcome 1


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Comparison          



Outcome          



Subgroup          



Timepoint
(specify whether from start or end of intervention)
          



ResultsInterventionComparison     


No. eventsNo. participantsNo. eventsNo. participants




                    






No. missing participants and reasons               




No. participants moved from other group and reasons               




Any other results reported          



Unit of analysis (by individuals, cluster/groups or body parts)

 
          



Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          



Reanalysis required? (specify)          

Yes     No    Unclear
          




Reanalysis possible?          

Yes     No    Unclear
          




Reanalysed results          



Notes:        

 

 




 

Continuous outcome


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Comparison          



Outcome          



Subgroup          



Timepoint
(specify whether from start or end of intervention)
          



Post-intervention or change from baseline?          



ResultsInterventionComparison 



MeanSD (or other variance)No. participantsMeanSD (or other variance)No. participants     






                              








No. missing participants and reasons               




No. participants moved from other group and reasons               




Any other results reported

 
          



Unit of analysis

(individuals, cluster/ groups or body parts)
          



Statistical methods used and appropriateness of these methods (e.g. adjustment for correlation)          



Reanalysis required? (specify)          

Yes     No    Unclear
          




Reanalysis possible?          

Yes     No    Unclear
          




Reanalysed results          



Notes:        

 

 
 





 

Other outcome


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)



Comparison          



Outcome          



Subgroup          



Timepoint
(specify whether from start or end of intervention)
          



ResultsIntervention resultSD (or other variance)Control resultSD (or other variance)     




                    




Overall resultsSE (or other variance)


          




No. participantsInterventionControl 


          




No. missing participants and reasons               




No. participants moved from other group and reasons               




Any other results reported          



Unit of analysis (by individuals, cluster/groups or body parts)          



Statistical methods used and appropriateness of these methods          



Reanalysis required? (specify)          

Yes     No    Unclear
          




Reanalysis possible?          

Yes     No    Unclear
          




Reanalysed results          



Notes:        

 

 




 

 

10. Applicability

 


Have important populations been excluded from the study? (consider disadvantaged populations, and possible differences in the intervention effect)          

Yes     No    Unclear
     

Is the intervention likely to be aimed at disadvantaged groups? (e.g. .lower socioeconomic groups)          

Yes     No    Unclear
     

Does the study directly address the review question?

(any issues of partial or indirect applicability)
          

Yes     No    Unclear
     

Notes:        

 

 



 

 

11. Other information

 


 Description as stated in report/paper

 
Location in text

(pg & ¶/fig/table)

Key conclusions of study authors

 
          

References to other relevant studies

 
          

Correspondence required for further study information (from whom, what and when)     


Notes:        

 

 



 

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

Conceiving the review: all authors

Co-ordinating the review: Amanda Ullman

Undertaking manual searches: Amanda Ullman

Screening search results: Amanda Ullman and Leanne Aitken

Organizing retrieval of papers: Amanda Ullman

Screening retrieved papers against inclusion criteria: Amanda Ullman and Leanne Aitken

Appraising quality of papers: Amanda Ullman, Leanne Aitken and Robyne le Brocque

Abstracting data from papers: Amanda Ullman, Leanne Aitken and Robyne le Brocque

Writing to authors of papers for additional information: Amanda Ullman

Providing additional data about papers: Amanda Ullman

Obtaining and screening data on unpublished studies: Amanda Ullman and Leanne Aitken

Data management for the review: Amanda Ullman

Entering data into Review Manager (RevMan 5.1): Amanda Ullman

RevMan statistical data: Amanda Ullman and Stephen MacGillivray

Other statistical analysis not using RevMan: Amanda Ullman

Interpretation of data: all authors

Statistical inferences: Stephen MacGillivray

Writing the review: all authors

Securing funding for the review: N/A

Performing previous work that was the foundation of the present study: all authors

Guarantor for the review (one author): Amanda Ullman

Person responsible for reading and checking review before submission: Amanda Ullman

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support

The authors have no conflicts of interests to declare.

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Acknowledgements
  6. Appendices
  7. Contributions of authors
  8. Declarations of interest
  9. Sources of support
 

Internal sources

  • NH&MRC Centre of Research Excellence in Nursing Interventions, Griffith University, Australia.
  • Research Centre for Clinical and Community Practice Innovation, Griffith University, Australia.
  • Princess Alexandra Hospital, Woolloongabba, Australia.
  • School of Nursing and Midwifery, University of Dundee, UK.
  • Department of Psychiatry, NHS Tayside, Perth, UK.
  • School of Medicine, University of Queensland, Australia.
  • Centre of National Research on Disability and Rehabilitation Medicine, University of Queensland, Australia.
  • Social Dimensions of Health Institute, University of Dundee, UK.

 

External sources

  • No sources of support supplied

References

Additional references

  1. Top of page
  2. Abstract
  3. Background
  4. Objectives
  5. Methods
  6. Acknowledgements
  7. Appendices
  8. Contributions of authors
  9. Declarations of interest
  10. Sources of support
  11. Additional references
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