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Wound-care teams for preventing and treating pressure ulcers

  1. Zena EH Moore1,*,
  2. Joan Webster2,
  3. Ray Samuriwo3

Editorial Group: Cochrane Wounds Group

Published Online: 5 MAR 2014

DOI: 10.1002/14651858.CD011011


How to Cite

Moore ZEH, Webster J, Samuriwo R. Wound-care teams for preventing and treating pressure ulcers (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD011011. DOI: 10.1002/14651858.CD011011.

Author Information

  1. 1

    Royal College of Surgeons in Ireland, School of Nursing & Midwifery, Dublin, Ireland

  2. 2

    Royal Brisbane and Women's Hospital, Centre for Clinical Nursing, Brisbane, Queensland, Australia

  3. 3

    University of Leeds, School of Healthcare, Faculty of Medicine and Health, Leeds, UK

*Zena EH Moore, School of Nursing & Midwifery, Royal College of Surgeons in Ireland, 123 St. Stephen's Green, Dublin, D2, Ireland. zmoore@rcsi.ie.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 5 MAR 2014

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Background

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

Description of the condition

A pressure ulcer is defined as a localised injury to the skin or underlying tissue, or both, usually over a bony prominence, as a result of pressure, or pressure in combination with shear. A number of contributing or confounding factors are also associated with pressure ulcers, the significance of which have yet to be elucidated (EPUAP/NPUAP 2009). Pressure ulcers are commonly classified according to the depth of tissue damage, ranging from non-blanching erythema of intact skin (tissue redness that does not turn white when pressed) to full-scale tissue destruction (EPUAP/NPUAP 2009).

A large number of risk factors may contribute to pressure ulcer development (Moore 2008), and in keeping with the EPUAP/NPUAP 2009 guidance, Coleman 2013 argues that a complex interplay of these factors increases the probability of pressure ulcer development. There are three primary risk factors of particular significance, namely; mobility and activity; impaired perfusion (circulation problems, possibly due to diabetes); and fragile skin or existing or previous pressure ulcers (Coleman 2013). These risk factors mean that certain populations, such as the very old and those with an inability to reposition themselves freely, are at greater risk of developing pressure ulcers (Moore 2012).

'Prevalence' refers to the number of people with a pressure ulcer at a point in time, or during a specific time period, while 'incidence' concerns the rate at which new pressure ulcers develop in a defined population in a specific time period (Beaglehole 1993). Prevalence and incidence studies indicate that pressure ulcers are common. Indeed, prevalence rates range from 0.38% to 53.2% (Capon 2007; Igarashi 2013; Keelaghan 2008; Kwong 2011; Lahmann 2006; Moore 2012; Moore 2013b; Stevenson 2013; Tubaishat 2010; Vanderwee 2007), and incidence rates vary from 1.9% to 71.6% across Europe, Japan, China, the Middle East, the United States of America (USA), Australia and Canada (Defloor 2005; Igarashi 2013; Jolley 2004; Kwong 2011; Moore 2011; Moore 2013b; Scott 2006). Mean prevalence has been reported as being 20.9% within the acute-care setting, and 11.7% within the long-stay setting; among hospice patients the mean figure is reported to be 35.7%, but drops to 0.04% to 4% for those nursed in the community (Moore 2013b). Incidence figures among the different care settings are similar to prevalence figures. For example, mean incidence of pressure ulcers in the acute-care setting has been reported as being 18% and for the long-stay setting the figure is 6.6%. There is little information available about pressure ulcer incidence within the community-care setting (Moore 2013b).

The impact of pressure ulcers on the individual is profound, spanning the physical, emotional and social domains of life (Gorecki 2009). This impact is largely influenced by factors related to the individual themselves, the healthcare professional and the environment of care delivery (Gorecki 2012). Fundamentally, those living with pressure ulcers experience significant anxieties that relate to their experiences of the ulcer, for example, the presence of unrelieved intractable pain, in addition to challenges to their ability to cope with the demands that treatments impose upon them (Gorecki 2012).

From a European perspective, pressure ulcer management absorbs between 4% and 5% of the annual healthcare budget, with nurse or healthcare-assistant time accounting for up to 90% of the overall costs (Posnett 2009). In the USA, pressure ulcers cost between USD 9.1 billion to USD 11.6 billion per year (EUR 6.7 billion to EUR 8.5 billion), with estimates in 2007, that each pressure ulcer adds USD 43,180 (EUR 31,580) in costs to a hospital stay (Agency for Healthcare Research and Quality 2011). Within the acute care setting in Australia in 2005, median opportunity costs for pressure ulcers were estimated at AUD 285 million (EUR 202 million) (Graves 2005). The human and economic drain on healthcare systems is compounded by the fact that healthcare professionals and clinicians are often not trained in prevention and treatment of pressure ulcers, or remain in systems where multidisciplinary and integrated care processes are not in place, or both (Moore 2013a). Indeed, a higher incidence and prevalence of pressure ulcers has been noted in settings where there are poor organisational strategies for preventing and managing pressure ulcers (Igarashi 2013).

 

Description of the intervention

Since the late 1990s there have been reports of the impact that multidisciplinary wound care teams can have on pressure ulcer prevention and management in clinical practice (Doan-Johnson 1998; Dolynchuk 2000; Granick 1998). During this era, it was noted that there was an increasing number of formal and informal multidisciplinary wound care teams that adhered to specific patient-care protocols (Doan-Johnson 1998).

Once the best available evidence on the most appropriate way to improve patients' wound-related outcomes had been synthesised and integrated with expert opinion, multidisciplinary wound care teams were created in many settings through the consensus of healthcare professionals with an interest in wound care (Dolynchuk 2000; Gottrup 2003; Haworth 2009). Thus, multidisciplinary wound care teams were created to focus on delivering high quality, holistic and patient-specific skin care to improve patients’ wound-related outcomes and to prevent the deterioration of the integrity of patients' tissue (Dolynchuk 2000; Gottrup 2003; Haworth 2009).

The exact composition of the multidisciplinary wound care team is mainly determined by the patient’s needs, thus, potentially, any healthcare professional can be a member if it is in the patient’s best interest (Gottrup 2004; Clark 2007; Zulkowski 2007; Haworth 2009). It is evident, therefore, that multidisciplinary wound care teams can consist of different healthcare professionals. Teams' key roles include overseeing the pressure ulcer-related education of staff, patients and carers; undertaking pressure ulcer-related research; and supervising the patient’s pressure ulcer prevention and management strategies (Dolynchuk 2000; Gottrup 2004; Ryan 2003; Woo 2008).

While a number of different approaches to the formation of multidisciplinary wound care teams have been reported in clinical practice, they are all said to have had a positive impact on the wound prevention and management care that patients receive (Gottrup 2003; Gottrup 2004; Haworth 2009). Indeed, in one hospital, the multidisciplinary wound care team was found to have reduced the prevalence of pressure ulcers by 18% over three years, and in a different hospital the team was reported to have reduced the pressure ulcer prevalence by 15% in one year (Granick 1998). In another setting, the multidisciplinary wound care team was reported to achieve a high rate of wound healing as 68% of 103 patients with chronic wounds achieved complete or almost complete wound healing, and only 2% of the patients had the recurrence of an old wound (Donnelly 2000). However, the studies referred to here lack the rigor required to clearly determine the impact of the introduction of the multidisciplinary wound care team, because they use a pre-post test design with significant time gaps between the pre and post test, and outcome data were collected using an audit methodology.

 

How the intervention might work

The intervention in this review is the wound care team: this review will consider the impact that these teams have on pressure ulcer prevention and management. We define the wound care team as a formally-constituted team of healthcare professionals who work closely to supervise the pressure ulcer prevention and management care of people in hospitals or the community-care setting, or both. The team may be multidisciplinary (e.g. any combination of dietician, nurse, medical doctor, physiotherapist, occupational therapist) or uni-disciplinary (e.g. team composed entirely of nurses). The team may focus on a simple strategy (e.g. a turning only regime) or a complex strategy (e.g. dietary, mobilisation, education).

The World Health Organisation (WHO) argues that collaborative practice strengthens healthcare systems and improves health outcomes (WHO 2010). Furthermore, WHO suggests that such an approach to care delivery is key to optimising individual patient outcomes (WHO 2010), thereby enhancing overall health and social gain. Indeed, a lack of integrated care systems and functioning multidisciplinary teams compounds the suffering of patients and increases demands on already overstretched health budgets (Moore 2005). Conversely, structured multidisciplinary interventions, such as interdisciplinary collaboration and education, improve patient outcomes and overall health service delivery (Apelqvist 2000).

The multidisciplinary wound care team is expected to deliver better outcomes compared to the alternative, where a patient's pressure ulcer prevention and management-related care is delivered by one group of healthcare professionals, without the insight, expertise and active participation of fellow healthcare professionals. There are a number of factors that can contribute to the formation of pressure ulcers, or can affect the healing of pressure ulcers, which are perhaps best addressed by pooling the expertise of different healthcare professionals in order to enhance patient pressure ulcer prevention and management-related outcomes. Thus, the multidisciplinary wound care team may have a positive impact on these outcomes because it brings together a range of healthcare professionals with different expertise in order to plan and deliver care to prevent and manage pressure ulcers in a holistic way that is designed to suit the patient’s individual needs.

 

Why it is important to do this review

International guidelines suggest that to prevent and manage pressure ulcers successfully a team approach is required (Agency for Healthcare Research and Quality 2011; EPUAP/NPUAP 2009). Furthermore, a team approach to care delivery is advocated by WHO (WHO 2010). Although there have been many reports about the positive impact that wound care teams have had on pressure ulcer prevention and management, many of these reports appear to have been underpinned by anecdotal evidence, or have been subjected to little critical scrutiny, so overall, the precise impact of wound care teams is unclear. Therefore, it is important to search and appraise the literature systematically in order to determine the impact of teams on the prevention and management of pressure ulcers. The outcomes of this review will provide clinical decision-makers with the evidence they need to determine whether investment in such teams is of value.

 

Objectives

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

To assess the impact of wound care teams on preventing and treating pressure ulcers in people of any age, nursed in any setting.

 

Methods

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

Criteria for considering studies for this review

 

Types of studies

We will include randomised controlled trials (RCTs) that evaluate the effect of any configuration of wound care teams in the treatment or prevention of pressure ulcers. For this intervention, there is a high probability that hospitals, or wards within hospitals, rather than individuals, will be randomised. Consequently, we will also include cluster-randomised trials if the cluster design has been properly accounted for in the trial's analysis. We will also consider including cluster-RCTs if information is available in the paper, or from the investigator, that would allow us to conduct an appropriate analysis. We will exclude trials that do not use a validated instrument (such as the EPUAP/NPUAP 2009 definitions) to assess pressure ulcers. We will also exclude studies using quasi-randomisation, cross-over studies, controlled before-and-after studies and interrupted-time-series studies.

 

Types of participants

People of any age, in any setting (hospitals, nursing homes, residential care, rehabilitation centres) who are at risk of developing a pressure ulcer (as identified through either a structured or unstructured risk assessment, or by clinical judgement alone), or who have an existing pressure ulcer (of any stage), will be eligible for inclusion.

 

Types of interventions

The intervention of interest is a team that focuses on pressure ulcer prevention, or treatment, or both. The team may be multidisciplinary (e.g. any combination of dietician, nurse, medical doctor, physiotherapist, occupational therapist) or uni-disciplinary (e.g. team composed entirely of nurses). The team may focus on a simple strategy (e.g. a turning only regime) or a complex strategy (e.g. dietary, mobilisation, education).

The impact of the wound care team on pressure ulcer prevention and management will be compared against the delivery of care to prevent or manage pressure ulcers by an individual healthcare professional.

 

Types of outcome measures

Primary and secondary outcomes will be considered under two categories, prevention and treatment.

 

Primary outcomes

 

Prevention studies

  • Pressure ulcer incidence (the proportion of participants developing any new pressure ulcer(s) of any grade).

 

Treatment studies

The primary outcome for treatment studies is complete healing, but this may be measured and reported in several ways by trial authors. We will include RCTs that report any of the following:

  • an objective measure of pressure ulcer healing such as absolute or percentage change in pressure ulcer area or volume over time; proportion of individuals with pressure ulcers healed at the completion of the trial period; or healing rate (we will accept trials with any length of follow-up, we will adjust for any differences in our analyses);
  • time to complete wound healing (using methods of survival analysis and expressing the intervention effect as a hazard ratio).

 

Secondary outcomes

 

Prevention studies

  • Resource use (including costs associated with the team and those costs associated with dressings and other additional interventions where reported).
  • Length of hospital stay.
  • Satisfaction (using any validated scale).
  • Morbidity (e.g. infection).

 

Treatment studies

  • Pain (measured at any time with any validated instrument e.g. Visual Analogue Scale).
  • All-cause mortality.
  • Health-related quality of life (using any validated measure such WHOQOL-BREF, SF-36, SF-12).
  • Cost (including resources associated with the team and those associated with dressings and other additional interventions where reported).
  • Morbidity (e.g. infection, proportion requiring surgical repair).
  • Mortality (pressure ulcer- or infection-related mortality).

 

Search methods for identification of studies

We will search the following electronic databases to identify reports of relevant randomised clinical trials or cluster-RCTs that evaluate the use of wound care teams for the prevention or treatment of pressure ulcers.

 

Electronic searches

We will search the following databases:

  • The Cochrane Wounds Group Specialised Register;
  • The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library) (latest issue);
  • Ovid MEDLINE (1946 to present);
  • Ovid EMBASE (1974 to present);
  • EBSCO CINAHL (1982 to present).

We will use the following strategy for CENTRAL:

#1 MeSH descriptor: [Patient Care Team] explode all trees
#2 ((care or health or healthcare or medical or nursing or interdisciplinary or multidisciplinary or wound* or turn*) next team*):ti,ab,kw
#3 ("team nursing" or nurse-led or nurse-centred):ti,ab,kw
#4 {or #1-#3}
#5 MeSH descriptor: [Pressure Ulcer] explode all trees
#6 (pressure next (ulcer* or sore* or injur*)):ti,ab,kw
#7 (decubitus next (ulcer* or sore*)):ti,ab,kw
#8 ((bed next sore*) or bedsore):ti,ab,kw
#9 {or #5-#8}
#10 #4 and #9

We will combine the Ovid MEDLINE search with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE: sensitivity- and precision-maximising version (2008 revision) (Lefebvre 2011). We will combine the EMBASE search with the Ovid EMBASE filter developed by the UK Cochrane Centre (Lefebvre 2011). We will combine the CINAHL searches with the trial filters developed by the Scottish Intercollegiate Guidelines Network (SIGN 2013). There will be no restrictions with respect to language, date of publication or study setting.

We will also search the following clinical trials registries:

 

Searching other resources

We will search reference lists of all included studies and other relevant publications, such as systematic reviews and guidelines. We will contact experts in the field and the authors of relevant publications to identify any completed or ongoing trials. We will also perform manual searches of conference proceedings to identify authors and papers related primarily to wound care teams for the prevention, or treatment, or both, of pressure ulcers.

 

Data collection and analysis

We will perform the systematic review according to instructions in the Cochrane Handbook for Systematic Reviews of Interventions (Green 2011).

 

Selection of studies

Two review authors will independently screen all titles and abstracts retrieved by the searches, and exclude those that clearly do not meet the inclusion criteria. We will obtain full texts of the remaining papers and they will be assessed by two review authors for eligibility. Any disagreement will be resolved by discussion between all review authors or, if consensus cannot be reached, by referral to the editorial base of the Cochrane Wounds Group.

 

Data extraction and management

Two review authors will independently extract data from eligible studies using a data extraction sheet developed for this purpose. Specifically, we will extract the following information:

  • author, title, source;
  • date of study, country of origin;
  • care setting;
  • inclusion and exclusion criteria;
  • baseline participant characteristics;
  • sample size calculation;
  • number of participants randomised to each arm;
  • study design details;
  • trial quality (method of randomisation; allocation concealment; blinding of the participant and outcome assessor; completeness of reporting);
  • intervention details (specifically team composition and focus of the intervention), concurrent intervention(s);
  • primary and secondary outcomes (with definitions);
  • length of follow-up;
  • loss to follow-up;
  • outcomes data for primary and secondary outcomes (by group);
  • intention-to-treat analysis;
  • funding source;
  • conflicts of interest.

Any differences in opinion will be resolved by discussion and, where necessary, with reference to the Cochrane Wounds Group editorial base. If data are missing from reports, we will attempt to contact study authors to obtain the missing information. We will include multiple reports of the same study to extract the maximal amount of information, ensuring that data are not duplicated. One review author will enter data into Review Manager 5.2 software (RevMan 2011), with a second author verifying accuracy.

 

Assessment of risk of bias in included studies

Independently, two review authors will assess the included studies using the Cochrane Collaboration tool for assessing risk of bias (Higgins 2011a). This tool addresses six specific domains, namely: sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other issues (e.g. extreme baseline imbalance). Appendix 1 contains details of the criteria on which this assessment will be based. We will assess blinding and completeness of outcome data for each outcome separately (for example, blinding is important for subjective outcomes such as pressure ulcer healing and pain). We will present our assessment of risk of bias using two 'Risk of bias' summary figures; one will be a summary of bias for each item across all studies, and the second will show a cross-tabulation of each trial by all of the risk of bias items. For trials using cluster randomisation, we will assess the risk of bias using the following domains: recruitment bias, baseline imbalance, loss of clusters, incorrect analysis and comparability with individually randomised trials (Higgins 2011b).

 

Measures of treatment effect

For dichotomous outcomes (e.g. proportion with a pressure ulcer) the risk ratio (RR) will be calculated with 95% confidence intervals (CI). For continuously distributed outcome data (e.g. pain) we will use the mean difference (MD) with 95% CIs, if all trials use the same assessment scale. If trials use different assessment scales, we will use the standardised mean difference (SMD) with 95% CI. Time-to-event data (e.g. time to complete wound healing), will be reported as hazard ratios (HR) where possible, in accordance with the methods described in the Cochrane Handbook for Systematic Reviews of Interventions (Deeks 2011). For statistically significant effects in binary outcomes, number needed to treat to benefit (NNTB), or number needed to harm (NNH), will be calculated. If skewness is suspected, and if scale data have finite upper and lower limits, we will use the easy 'rule of thumb' calculation to test for skewness. That is, if the standard deviation (SD), when doubled, is greater than the mean, it is unlikely that the mean is the centre of the distribution (Altman 1996), and we will not enter the data into any meta-analysis. If we find relevant data that are skewed, we will present the data in 'Other data' tables.

 

Summary of findings    [Explanations]

To assess the overall body of evidence, we will develop a summary of findings table using GRADE profilerTM. The quality of the body of evidence will be assessed against five principle domains: 1) limitations in design and implementation; 2) indirectness of evidence or generalisability of findings; 3) inconsistency of results - for example unexplained heterogeneity and inconsistent findings; 4) imprecision of results where confidence intervals are wide; and 5) other potential biases, for example publication bias or high manufacturer involvement (Shunemann 2011).

 

Unit of analysis issues

We will check unit of analysis issues if cluster RCTs are included. If required, and if sufficient data are available, we will recalculate results using the appropriate unit of analysis (Higgins 2011b). We will also note whether participants, or ulcers, have been randomised. Where there is evidence that multiple ulcers on a single person have been analysed incorrectly (that is, by considering outcomes for multiple ulcers as independent), we will seek further information from the trialist. For cluster trials that have used analysis methods to account for the clustering, we will extract effect sizes and standard errors from the appropriate analysis.

 

Dealing with missing data

Where possible, we will perform all analyses using the intention-to-treat (ITT) principle, that is, participants will be analysed according to their allocated treatment group. Where it appears that data have been excluded from the analyses, we will contact authors for these missing data. If data remain missing, despite our best efforts to obtain them, we will assume that those missing from the analysis of dichotomous data had a negative outcome (e.g. developed a pressure ulcer or did not completely heal). For continuous data, if standard deviations are missing, where possible, we will compute them from standard errors (SE) using the formula SD = SE x √N (Higgins 2011c). If this is not possible, we will impute SDs from similar continuous outcome data and use sensitivity analyses to assess the impact of the assumptions we make (i.e. using small or large SDs) (Higgins 2011b). Where results are reported for all participants, but it is unclear how many people were originally randomised, we will use an available-case analysis.

 

Assessment of heterogeneity

Clinical heterogeneity will be assessed in terms of how comparable trials are according to their inclusion criteria, intervention and outcome measures. Statistical heterogeneity will be assessed by visual inspection of forest plots, by the Chi2 test with significance set at 0.10, and by the I2 statistic, which examines the percentage of total variation across studies that is due to heterogeneity rather than chance (Higgins 2003). Where I2 values are 40% or less, we will consider heterogeneity to be low, and where I2 values exceed 75% we will consider it to be high.

 

Assessment of reporting biases

Reporting bias will be assessed using guidelines in the Cochrane Handbook for Systematic Reveiws of Interventions (Stern 2011). If enough studies are available for a meaningful assessment of publication bias, a funnel plot of primary outcomes will be constructed to test for asymmetry. We will also consider selective reporting (i.e. reporting some outcomes and not others) in our assessment of reporting bias.

 

Data synthesis

Initially we will present a structured narrative summary of the studies reviewed. Quantitative data will be entered into Review Manager for analysis (RevMan 2011). If included studies are sufficiently similar in terms of population, inclusion criteria, interventions and outcomes (including the times at which outcomes are assessed in both intervention and treatment trials) we will consider pooling the data statistically, using meta-analysis. We will use a fixed-effect model if appropriate (i.e. when I2 values are 40% or less), otherwise we will use a random effects model. We will not pool data where the I2 values are greater than 75%. A summary of results from the data synthesis and assessment of quality of evidence will be included in a 'Summary of findings' table for the main comparisons. Cluster trials will be combined with individually randomised trials in the same meta-analysis, using subgroups to assess the affect of the randomisation method. We will explore the possibility of important differences in the effects being evaluated in the different types of trials before conducting meta-analysis (Higgins 2011b). We will include trials that report time to event data as continuous, using means or medians, but results from these trials will be reported in the narrative and will not be included in any meta-analyses.

 

Subgroup analysis and investigation of heterogeneity

If substantial heterogeneity exists between studies for the primary outcomes (that is, when the I2 statistic exceeds 50%) ,we will explore reasons for heterogeneity. We envisage that the number of studies meeting our inclusion criteria may be low. Consequently, to avoid type 1 errors we plan to conduct a minimal number of sub-analyses that will include the following, if possible:

  • acute care versus residential care;
  • type of wound care team (e.g. single discipline versus multi-disciplinary);
  • type of intervention (single-factor versus multi-factorial).

 

Sensitivity analysis

Will will perform a sensitivity analysis by excluding those studies assessed as having a high risk of bias in the key domains of 'generating the randomisation sequence', 'allocation concealment' and 'blinding of outcome assessment'. We will also explore the effect of unpublished studies, small studies (less than 100 participants) and cluster trials, where the analysis was not at the same level as the allocation (i.e. allocation by cluster and analysis by individual).

 

Acknowledgements

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

The authors would like to acknowledge the contribution of the peer referees: Sonya Osborne, Gill Worthy, Jane Burch, Janet Gunderson and an expert referee who wishes to remain anonymous. In addition the contribution of the Copy Editor, Elizabeth Royle; the Cochrane Wounds Group Managing Editor, Sally Bell-Syer; and the Trials Search Co-ordinator Ruth Foxlee.

 

Appendices

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

Appendix 1. Risk of bias criteria

 
1. Was the allocation sequence randomly generated?
 
Low risk of bias

The investigators describe a random component in the sequence generation process such as: referring to a random number table; using a computer random-number generator; coin tossing; shuffling cards or envelopes; throwing dice; drawing of lots.

 
High risk of bias

The investigators describe a non-random component in the sequence generation process. Usually, the description would involve some systematic, non-random approach, for example: sequence generated by odd or even date of birth; sequence generated by some rule based on date (or day) of admission; sequence generated by some rule based on hospital or clinic record number.

 
Unclear

Insufficient information about the sequence generation process to permit judgement of low or high risk of bias to be made.

 
2.  Was the treatment allocation adequately concealed?
 
Low risk of bias

Participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomisation); sequentially-numbered drug containers of identical appearance; sequentially-numbered, opaque, sealed envelopes.

 
High risk of bias

Participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non­opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; any other explicitly unconcealed procedure.

 
Unclear

Insufficient information available to permit judgement of low or high risk of bias to be made. This is usually the case if the method of concealment is not described, or not described in sufficient detail to allow a definite judgement, for example if the use of assignment envelopes is described, but it remains unclear whether envelopes were sequentially numbered, opaque and sealed.

 
3.  Blinding - was knowledge of the allocated interventions adequately prevented during the study?
 
Low risk of bias

Any one of the following.

  • No blinding, but the review authors judge that the outcome and the outcome measurement are not likely to be influenced by lack of blinding.
  • Blinding of participants and key study personnel ensured, and unlikely that the blinding could have been broken.
  • Either participants or some key study personnel were not blinded, but outcome assessment was blinded and the non-blinding of others was unlikely to introduce bias.

 
High risk of bias

Any one of the following.

  • No blinding or incomplete blinding, and the outcome or outcome measurement was likely to be influenced by lack of blinding.
  • Blinding of key study participants and personnel attempted, but likely that the blinding could have been broken.
  • Either participants or some key study personnel were not blinded, and the non-blinding of others was likely to introduce bias.

 
Unclear

Either of the following.

  • Insufficient information available to permit judgement of low or high risk of bias to be made.
  • The study did not address this outcome.

 
4.  Were incomplete outcome data adequately addressed?
 
Low risk of bias

Any one of the following.

  • No missing outcome data.
  • Reasons for missing outcome data were unlikely to be related to true outcome (for survival data, censoring unlikely to be introducing bias).
  • Missing outcome data are balanced in numbers across intervention groups, with similar reasons for missing data across groups.
  • For dichotomous outcome data, the proportion of missing outcomes compared with observed event risk is not enough to have a clinically relevant impact on the intervention effect estimate.
  • For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes is not enough to have a clinically relevant impact on observed effect size.
  • Missing data have been imputed using appropriate methods.

 
High risk of bias

Any one of the following.

  • Reason for missing outcome data likely to be related to true outcome, with either imbalance in numbers or reasons for missing data across intervention groups.
  • For dichotomous outcome data, the proportion of missing outcomes compared with the observed event risk is enough to induce clinically relevant bias in intervention effect estimate.
  • For continuous outcome data, plausible effect size (difference in means or standardised difference in means) among missing outcomes is enough to induce clinically relevant bias in observed effect size.
  • ‘As-treated’ analysis done with substantial departure in the intervention received from that assigned at randomisation.
  • Potentially inappropriate application of simple imputation.

 
Unclear

Either of the following.

  • Insufficient reporting of attrition/exclusions to permit judgement of low or high risk of bias (e.g. number randomised not stated, no reasons for missing data provided).
  • The study did not address this outcome.

 
5.  Are reports of the study free of suggestion of selective outcome reporting?
 
Low risk of bias

Either of the following.

  • The study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way.
  • The study protocol is not available but it is clear that the published reports include all expected outcomes, including those that were pre-specified (convincing text of this nature may be uncommon).

 
High risk of bias

Any one of the following.

  • Not all of the study’s pre-specified primary outcomes have been reported.
  • One or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. sub scales) that were not pre-specified.
  • One or more of the reported primary outcomes was not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect).
  • One or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis.
  • The study report fails to include results for a key outcome that would be expected to have been reported for such a study.

 
Unclear

Insufficient information is available to permit a judgement of low or high risk of bias to be made. It is likely that the majority of studies will fall into this category.

 
6.  Other sources of potential bias
 
Low risk of bias

The study appears to be free of other sources of bias.

 
High risk of bias

There is at least one important risk of bias. For example, the study:

  • had a potential source of bias related to the specific study design used; or
  • had extreme baseline imbalance; or
  • has been claimed to have been fraudulent; or
  • had some other problem.

 
Unclear

There may be a risk of bias, but there is either:

  • insufficient information to assess whether an important risk of bias exists; or
  • insufficient rationale or evidence that an identified problem will introduce bias.

 

What's new

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


DateEventDescription

24 February 2015AmendedContact details updated.



 

Contributions of authors

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

Zena Moore: Conceived the review question, developed the protocol and coordinated the protocol development. Completed the first draft of the protocol, edited the protocol and performed part of writing or editing the protocol. Is a guarantor of the protocol.
Joan Webster: Conceived the review question and developed the protocol. Completed the first draft of the protocol, edited the protocol and performed part of writing the protocol. Is a guarantor of the protocol.
Ray Samuriwo: Conceived the review question and developed the protocol. Completed the first draft of the protocol, edited the protocol and performed part of writing the protocol. Is a guarantor of the protocol.

Contributions of editorial base:
Nicky Cullum: edited the protocol; advised on methodology, interpretation and protocol content.
Jo Dumville, Editor: approved the final protocol prior to submission.
Sally Bell-Syer: co-ordinated the editorial process. Advised on methodology, interpretation and content. Edited the protocol.
Ruth Foxlee: designed the search strategy and edited the search methods section.

 

Declarations of interest

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

Zena Moore: is a member of the medical advisory board of Systagenix Wound Management. The author, Zena Moore, has received an honorarium for speaking at professional meetings for KCI, ConvaTec, Systagenix Wound Management, Fanin Health Care, Molnlycke Health Care and Smith & Nephew.
Joan Webster: nothing to declare
Ray Samuriwo: nothing to declare

 

Sources of support

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

Internal sources

  • Royal College of Surgeons in Ireland, Ireland.

 

External sources

  • The National Institute for Health Research (NIHR) is the sole funder of the Cochrane Wounds Review Group, UK.

References

Additional references

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