Polineuropatía Paciente Critico Cochrane 2015

8/9/2019 Polineuropatía Paciente Critico Cochrane 2015

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Physical rehabilitation for critical illness myopathy and

neuropathy (Review)

Mehrholz J, Pohl M, Kugler J, Burridge J, Mückel S, Elsner B

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2015, Issue 3

http://www.thecochranelibrary.com

Physical rehabilitation for critical illness myopathy and neuropathy (Review)

Copyright © 2015 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

7DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8 AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

8 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

12CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

22SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .

iPhysical rehabilitation for critical illness myopathy and neuropathy (Review)



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[Intervention Review]

Physical rehabilitation for critical illness myopathy andneuropathy

Jan Mehrholz1,2, Marcus Pohl3, Joachim Kugler2, Jane Burridge4, Simone Mückel1, Bernhard Elsner2

1 Wissenschaftliches Institut, Private Europäische Medizinische Akademie der Klinik Bavaria in Kreischa GmbH, Kreischa, Germany.2Department of Public Health, Dresden Medical School, Technical University Dresden, Dresden, Germany. 3 Abteilung Neurologie

und Fachübergreifende Rehabilitation, Klinik Bavaria Kreischa, Kreischa, Germany. 4Research Group, Faculty of Health Sciences,

University of Southampton, Southampton, UK

Contact address: Jan Mehrholz, Wissenschaftliches Institut, Private Europäische Medizinische Akademie der Klinik Bavaria in Kreischa

GmbH, An der Wolfsschlucht 1-2, Kreischa, 01731, Germany. [email protected].

Editorial group: Cochrane Neuromuscular Disease Group.

Publication status and date: New, published in Issue 3, 2015.

Review content assessed as up-to-date: 14 July 2014.

Citation: Mehrholz J, Pohl M, Kugler J, Burridge J, Mückel S, Elsner B. Physical rehabilitation for critical illness myopathy and

neuropathy. Cochrane Database of Systematic Reviews 2015, Issue 3. Art. No.: CD010942. DOI: 10.1002/14651858.CD010942.pub2.


A B S T R A C T

Background

Intensive care unit (ICU) acquired or generalised weakness due to critical illness myopathy (CIM) and polyneuropathy (CIP) are major

causes of chronically impaired motor function that can affect activities of daily living and quality of life. Physical rehabilitation of those

affected might help to improve activities of daily living.

Objectives

Our primary objective was to assess the effects of physical rehabilitation therapies and interventions for people with CIP and CIM in

improving activities of daily living such as walking, bathing, dressing and eating. Secondary objectives were to assess effects on muscle

strength and quality of life, and to assess adverse effects of physical rehabilitation.

Search methods

On 16 July 2014 we searched the Cochrane Neuromuscular Disease Group Specialized Register and on 14 July 2014 we searched

CENTRAL, MEDLINE, EMBASE and CINAHL Plus. In July 2014, we searched the Physiotherapy Evidence Database (PEDro,

http://www.pedro.org.au/) and three trials registries for ongoing trials and further data about included studies. There were no language

restrictions. We also handsearched relevant conference proceedings and screened reference lists to identify further trials.

Selection criteria

Weplanned to include randomised controlled trials (RCTs), quasi-RCTs and randomised controlled cross-over trials of any rehabilitation

intervention in people with acquired weakness syndrome due to CIP/CIM.

Data collection and analysis

We would have extracted data, assessed the risk of bias and classified the quality of evidence for outcomes in duplicate, according to

the standard procedures of The Cochrane Collaboration. Outcome data collection would have been for activities of daily living (for

example, mobility, walking, transfers and self care). Secondary outcomes included muscle strength, quality of life and adverse events.

1Physical rehabilitation for critical illness myopathy and neuropathy (Review)


mailto:[email protected]://www.pedro.org.au/http://www.pedro.org.au/http://www.pedro.org.au/http://www.pedro.org.au/mailto:[email protected]


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Main results

The search strategy retrieved 3587 references. After examination of titles and abstracts, we retrieved the full text of 24 potentially

relevant studies. None of these studies met the inclusion criteria of our review. No data were suitable to be included in a meta-analysis.

Authors’ conclusions

There are no published RCTs or quasi-RCTs that examine whether physical rehabilitation interventions improve activities of daily

living for people with CIP and CIM. Large RCTs, which are feasible, need to be conducted to explore the role of physical rehabilitation

interventions for people with CIP and CIM.

P L A I N L A N G U A G E S U M M A R Y

Rehabilitation interventions for people with critical illness myopathy and neuropathy

Review question

Does physical rehabilitation aid recovery of people with weakness that develops in muscles (critical illness myopathy, CIM) and nerves

(critical illness polyneuropathy, CIP) in critical care?

Background

CIM and CIP are common complications of critical care. Both CIM and CIP cause limb weakness and weakness of muscles used for

breathing. CIM and CIP make people more unwell, increase mortality and slow down recovery. CIP and CIM are major causes of

long-term difficulties with movement. These difficulties can affect ’activities of daily living’ - everyday tasks such as bathing, dressing,

eating, leisure activities and participation in family life). Recovery takes weeks or months. When CIM/CIP is severe, there may be little

or no recovery.

Physical rehabilitation for people with CIM or CIP may help recovery and improve activities of daily living and may prevent complica-

tions. Physical rehabilitation includes stretching exercises and training to build up strength, and practical training in dressing, transfers

(e.g. from chair to bed), rising from sitting to standing, walking and balance.

Study characteristics

We carried out an extensive search of the medical literature for randomised controlled trials (RCTs) of physical rehabilitation treatments

for CIM or CIP.

Key results

We found no high quality trials that met our stringent criteria for inclusion in this review.

Quality of the evidence

Currently there are no RCTs that test whether physical rehabilitation improves activities of daily living for people with CIM/CIP. Well-

conducted research is required to determine the effects of rehabilitation in CIM/CIP.

This evidence is up to date to July 2014.

B A C K G R O U N D

Description of the condition

Critical illness myopathy (CIM) and polyneuropathy (CIP) are

common complications of critical illness that frequently occur




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together. Both conditions cause weakness of limb and respiratory

muscles, and consequently increase morbidity and mortality, and

impede recovery.

CIP is a distal axonal sensory-motor polyneuropathy, which means

that multiple nerves that control movement and transmit sen-

sory information are affected. CIP presents as limb and respira-tory muscle weakness (Fan 2012; Lacomis 2000), and is closely

associated with a failure to wean people from mechanical ventila-

tion (Fan 2012; Latronico 2011). The diagnostic criteria for CIP

as a dysfunction of (multiple) peripheral nerves are, according to

Bolton 2005 and Latronico 2011, as follows:

1. The individual is critically ill (multi-organ dysfunction and

failures).

2. The individual has limb weakness, or is difficult to wean

from a ventilator (after exclusion of non-neuromuscular causes

such as heart and lung disease).

3. There is electrophysiological evidence of axonal motor and

sensory polyneuropathy.

4. There is an absence of a decremental response on repetitivenerve stimulation (Latronico 2011).

A definite diagnosis of CIP, according to Bolton 2005 and

Latronico 2011, is established if all four criteria are fulfilled. A

probable diagnosis of CIP is established if criteria one, three and

four are fulfilled.

CIM is a primary myopathy (i.e. a muscle disorder) that is not

secondary to muscle denervation, and which has characteristic

electrophysiological andmorphological changes (Latronico 2011).

The diagnostic criteria for critical illness myopathy are, according

to Latronico 2011, as follows:

1. The individual is critically ill (multi-organ dysfunction and

failures).

2. The individual has limb weakness, or is difficult to weanfrom a ventilator (after exclusion of non-neuromuscular causes

such as heart and lung disease).

3. Compound muscle action potential (CMAP) amplitudes

are less than 80% of the lower limit of normal in two or more

nerves when recorded without conduction block.

4. Sensory nerve action potential amplitudes are more than

80% of the lower limit of normal.

5. Needle electromyography detected:

i) short duration, low-amplitude motor unit potentials

with early or normal full recruitment, with or without

fibrillation potentials in conscious and co-operative patients; or

ii) increased CMAP duration or reduced muscle

membrane excitability on direct muscle stimulation in non-co-operative patients.

6. Absence of a decreasing response to repetitive nerve

stimulation.

7. Muscle histopathological findings of primary myopathy (for

example, myosin loss or muscle necrosis).

Fulfilment of all criteria establishes a definite diagnosis of CIM

(Latronico 2011). Fulfilment of only criteria one and three to six

establishes a probable diagnosis of CIM. For our review we will

apply these definitions of CIP and CIM.

The pathophysiology of CIP and CIM is complex and remains

unclear (Hermans 2008). The development of CIP and CIM is

thought to involve electrical, microvascular, metabolic and bioen-

ergetic pathophysiological mechanisms (see Hermans 2008 for a good overview). Crucial risk factors for CIP and CIM are sep-

sis, systemic inflammatory response syndrome and multiple organ

failure (Hermans 2008).

Exact numbers and rates of CIP and CIM are not well established

because of variations in the patient population, risk factors and the

diagnostic and assessment criteria used. In people receiving me-

chanical ventilation or with an increased risk of developing multi-

organ failure, the risk of developing CIP or CIM is about 30%

and the risk increases up to 50% in people with acute respira-

tory distress syndrome (Hermans 2008). The risk of developing

CIP or CIM is associated with a lengthy (more than one week)

stay in the intensive care unit (ICU), multi-organ failure (with

or without sepsis) and systemic inflammatory response syndrome(Bercker 2005; Hermans 2008). A systematic review estimated

the incidence of CIP and CIM at 46% (95% CI 43% to 49%)

among adults who had remained in the ICU for more than two

weeks, who were receiving mechanical ventilation and had sepsis

or multi-organ failure (Stevens 2007).

The short- and long-term impact of CIP and CIM are well de-

scribed (Hermans 2008; Herridge 2011; Ohtake 2012). The mus-

cle weakness associated with these conditions canprolong the need

for supported ventilation and delay weaning from a ventilator. In

turn, this can mean a longer stay in the ICU and in hospital, and

slower rehabilitation (Hermans 2008; Zanni 2010). Although full

recovery has been reported in approximately 50% of people with

CIM/CIP, improvement is related to the severity of the condition.People who are only mildly affected can recover within weeks, but

those with more severe weakness may take months to improve or,

in some cases, remain severely affected with partial or no recov-

ery (Hermans 2008). Clinical and neurophysiological signs may

remain for up to five years after discharge from hospital and may

lead to long-term paresis or paralysis (Herridge 2011).

Weakness due to CIP and CIM is a major cause of chronically im-

paired motor function that can affect activities of daily living and

quality of life. Physical rehabilitation of those affected is therefore

of great importance and interest.

Description of the interventionIn the last five years, research has suggested that physical reha-

bilitation may improve function or functional ability and may

prevent complications such as contractures in people with CIP

and CIM (Bemis-Dougherty 2012; Connolly 2012; Fan 2012;

Nordon-Craft 2012; Ohtake 2012). Physical rehabilitation inter-

ventions include physical and occupational therapy techniques,

such as stretching (e.g. ranging exercises), strength training and




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mobility training (for example, training in dressing and transfers,

or to improve balance, sit-to-stand and walking) (Burtin 2009;

Fan 2012; Hanekom 2011; Herridge 2011; Nordon-Craft 2012).

There has, however, been no Cochrane review of the available lit-

erature on the efficacy and acceptability of physical rehabilitation

approaches to treat people who have developed CIP and CIM.

Why it is important to do this review

Advances in medical care, increased survival rates and better di-

agnosis of CIP and CIM, as well as the availability of more effec-

tive therapy, have highlighted the need for and potential value of

rehabilitation for people with critical illness. However, although

rehabilitation guidelines give recommendations, there is limited

evidence on which to base practice (Connolly 2012). People with

ICU-acquired weakness may be most likely to benefit from ongo-

ing rehabilitation (Connolly 2012). A recent special issue in the

journal Physical Therapy underlined the importance of the topic;

the authors concluded that physical rehabilitation approachesfor improving activities of daily living after CIP/CIM showed

some promising signs of effectiveness (Bemis-Dougherty 2012;

Nordon-Craft 2012), but there was a need for more evidence to

support evidence-based guidelines.

In addition to the question of whether physical rehabilitation in

general is beneficial, it is still unclear which specific rehabilitation

approaches are effective, and the most appropriate frequency and

intensity with which to apply them in practice (Connolly 2012).

There is currently no Cochrane systematic review in this area. We

therefore aim, inthis Cochrane review, to compile and assessall the

available literature about the effectiveness and safety of physical

rehabilitation in CIP and CIM, so as to provide comprehensive,

up-to-date evidence on which to base clinical practice.

O B J E C T I V E S

Our primary objective was to assess the effects of physical rehabil-

itation therapies and interventions for people with CIP and CIM

in improving activities of daily living such as walking, bathing,

dressing and eating. Secondary objectives were to assess effects on

muscle strength and quality of life, and to assess adverse effects of

physical rehabilitation.

M E T H O D S

Criteria for considering studies for this review

Types of studies

We considered for inclusion randomised controlled trials (RCTs),

quasi-RCTs and randomised controlled cross-over trials. Quasi-

RCTs are trials in which the method used to allocate participants

to interventions is not truly random (for example, using date of

birth or hospital number, or alternation strategies).

Types of participants

We considered participants aged 18 and over in both inpatient

and outpatient settings, who have weakness and a confirmed or

probable diagnosis of CIP or CIM. We defined CIP and CIM as

stated above. We did not include studies where no such criteria

were explicitly fulfilled. We included studies with mixed popu-

lations of people with neurological conditions if we were able to

obtain the data for participants with weakness due to CIP or CIM.

Types of interventions

We considered for inclusion all trials of CIM and CIP that com-

pared any physical rehabilitation intervention, such as physiother-

apy or occupational therapy, or both, with any other interventions

that aimed to improve function and activities of daily living. Pos-

sible and typical interventions in this review might be cycling, sit-

to-stand training, walking and gait training, and neuromuscular

electrical stimulation to lower extremity muscle groups. There are

many varying interventions therefore we planned to describe the

individual interventions in more detail once they were identified.

We included all studies of inpatient and outpatient physical re-

habilitation in the acute and chronic phase that compared two or

more interventions; for example, neuromuscular electrical stimu-

lation versus usual therapy, or neuromuscular electrical stimula-

tion versus another active intervention (such as muscle strength

training, dressing exercises or gait training). The intervention and

control group must have received the same (usual) medication or

rehabilitation. We therefore allowed co-interventions as long as

they were the same for all randomised participants.

Types of outcome measures

The time frame for outcome measurement was immediately after

the intervention and at follow-up one year later.

Primary outcomes

Our primary outcome measure was activities of daily living (for

example, mobility, walking, transfers and self care), as measured

by validated outcome tools.

Measurement tools were the Functional Independence Measure

(FIM) (Dodds 1993), the Barthel Index (Mahoney 1965), and

other validated scales for the ICU such as the Functional Status

Score for ICU (FSS-ICU) (Zanni 2010), the Acute Care Index




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of Function (ACIF) (Roach 1988), the Physical Function Out-

come Measure (PFIT) (Skinner 2009), or other validated mea-

sures. Measures of walking ability were gait speed in metres per

second and six-minute walking distance and other validated mea-

sures (Nordon-Craft 2012).

If studies used multiple scales to measure our primary outcome, we planned, in the absence of our preferred measures, to report all

scales and measures used.

Secondary outcomes

We reported the following secondary outcomes.

1. Muscle strength (as measured by, for example, the Medical

Research Council (MRC) Scale for Muscle Strength (Fan 2012)).

2. Quality of life measured by validated measures, such as the

Short Form-36 Health Survey (SF-36) (Skinner 2011), the

RAND-36 (Kaarlola 2006), or the Assessment of Quality of Life

(AQol) Utility Instrument (Denehy 2008).3. Frequency of adverse effects as a result of the intervention;

all serious adverse events defined as: life-threatening, requiring

prolonged hospitalisation or that are fatal; adverse events that

occur during the intervention or within 12 months of the

recruitment to the study.

We planned to report any information on costs in the ’Discussion’.

Search methods for identification of studies

Electronic searches

On 16 July 2014, we searched the Cochrane Neuromuscular Dis-

ease Group Specialized Register, the Cochrane Central Register of

Controlled Trials (CENTRAL 2014, Issue 6), MEDLINE (Jan-

uary 1966 to June 2014), EMBASE (January 1947 to June 2014),

CINAHL Plus (January 1937 to June 2014) and the Physio-

therapy Evidence Database (PEDro, http://www.pedro.org.au/).

The detailed search strategies are in the appendices: CENTRAL

( Appendix 1), MEDLINE ( Appendix 2), EMBASE ( Appendix 3),

CINAHL Plus ( Appendix 4) and Cochrane Neuromuscular Dis-

ease Group Specialized Register ( Appendix 5). There were no lan-

guage restrictions. The Cochrane Neuromuscular Disease Group

Trials Search Co-ordinator provided the search of the Specialized

Register; the review authors developed the other strategies.

We searched ClinicalTrials.gov (clinicaltrials.gov/) ( Appendix

6), the World Health Organization International Clinical Tri-

als Registry Platform (ICTRP) portal ( who.int/ictrp/en/) (

Appendix 7) and the European Union Clinical Trials Register (

clinicaltrialsregister.eu) for ongoing trials and further data about

included studies.

Searching other resources

We reviewed the bibliographies of any identified RCTs and con-

tacted the authors and known experts in the field to identify ad-

ditional published or unpublished data.


Selection of studies

Two review authors (JM and MP) independently selected the eli-

gible trials based on the predefined selection criteria and resolved

disagreement through discussion with the other review authors. If

we needed further information, we contacted trial authors.

For additional methods described in the protocol (Mehrholz

2014a ), see Appendix 8.

R E S U L T S

Description of studies

Results of the search

The search strategy retrieved 3591 references to studies after dedu-

plication. The number of papers found by the search strategies in

the appendices were:

• MEDLINE - 96 papers;• EMBASE - seven papers;

• CINAHL Plus - 2666 papers;

• Cochrane Neuromuscular Disease Group Specialized

Register - 23 papers;

• CENTRAL - 808 papers.

The following databases are included in The Cochrane Library :• NHSEED (NHDS Economic Evaluation Database) - 22

papers;

• DARE (Database of Abstracts of Reviews of Effectiveness) -

15 papers;

• HTA (Health Technology Assessment Database) - one

paper.

Weexamined the titles and abstracts of these references, and sought

full-text copies of potentially relevant studies. We examined the

bibliographical references of these studies and so retrieved further

potential titles.

We identified a total of 3591 unique records through the searches.

After screening titles and abstracts, we excluded 3566 records and

obtained the full text of the remaining 25 articles. After further



http://www.pedro.org.au/http://clinicaltrials.gov/http://www.who.int/ictrp/en/http://www.clinicaltrialsregister.eu/http://www.clinicaltrialsregister.eu/http://www.who.int/ictrp/en/http://www.who.int/ictrp/en/http://www.who.int/ictrp/en/http://clinicaltrials.gov/http://www.pedro.org.au/http://www.pedro.org.au/http://www.pedro.org.au/


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assessment, we determined that no studies met the review inclu-

sion criteria. There were no ongoing trials fulfilling our inclusion

criteria in ClinicalTrials.gov or ICTRP. The flow of references is

shown in Figure 1.

Figure 1. Study flow diagram.




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Included studies

None of the retrieved studies met our inclusion criteria for this

review.

Excluded studies

The main reasons for exclusion were ’participants did not meet

our diagnostic criteria’ (22 studies) and ’not a RCT’ (two studies).

A full list of excluded studies is provided in the Characteristics of

excluded studies section.

Risk of bias in included studies

Not applicable.

Effects of interventions

No data were available for analysis.

D I S C U S S I O N

Summary of main results

We found no randomised controlled trials (RCTs) on the effects

of physical rehabilitation therapies for people with critical illness

myopathy (CIM) and polyneuropathy (CIP).

Overall completeness and applicability of evidence

The aim of our review was to identify RCTs but, using the de-

scribed methodology, our review team was unable to find any ev-

idence from RCTs for people with defined diagnoses of CIP and

CIM.

One could argue that in the absence of RCTs ’high quality’ non-

randomised trials should be mentioned from our search of liter-

ature. Although including non-randomised trials was beyond the

scope of this review, three review authors (JM, MP and SM) are

investigators in an ongoing cohort study (Mehrholz 2014b), and

we found a second example of exercise descriptions of physical re-

habilitation approaches for people with CIP/CIM (Berney 2012).

The authors of Berney 2012 described the safety and feasibility

of an exercise prescription. The investigators included a cohort of

74 people after five days following admission to the intensive care

unit (ICU) and applied a so called “protocolized” rehabilitation

and exercise training programme that commenced in the ICU and

continued on the acute care ward and for a further eight weeks

following hospital discharge as an outpatient programme (Berney

2012).

The investigators found that exercises (such as marching in place

and walking away from the bedside) that commence in the ICU

and continue through to an outpatient programme are safe and

feasible for survivors of critical illness. The authors used the Physi-

cal Function in ICU Test as a disability measure. However, the in-

clusion criteria were verybroad, because the investigators includedpeople admitted to the ICU for five or more days. Although many

of these people are at high risk of developing CIP/CIM, diagnos-

tic criteria for CIP/CIM were not clearly described. It is therefore

unclear how many people in this study developed a CIP/CIM ac-

cording to the diagnostic criteria described in our present review

(see Types of participants).

Mehrholz 2014b is a cohort study and still recruiting participants,

but includes people with ICU-acquired muscle weakness and a

properly definedand confirmed diagnosisof CIM/CIP. Theaim of

this study is to identify and to describe the amount and content of

physical rehabilitation exercises for people with CIP/CIM. Based

on an a priori sample size calculation, approximately 150 partici-

pants will be recruited from the ICU and followed up to one yearafter study onset. The investigators will describe the amount and

content of physical rehabilitation on a daily basis, using clinical

tests such as the Physical Function in ICU Test and the Func-

tional Status Score for the Intensive Care Unit scored as disability

measures and muscle strength and neuropsychological assessments

(Mehrholz 2014b). The investigators of this study use recovery of

walking function and mobility as primary outcomes (Mehrholz

2014b).

Both studies could therefore give valuable information about fu-

ture comparators in RCTs (see Implications for research).

Quality of the evidence

We found no RCT evidence.

Potential biases in the review process

We found no studies that met the pre-stated inclusion criteria.

The inclusion and exclusion process involved at least two review

authors and, where information was unclear, we contacted the

authors of studies for further clarification.

Agreements and disagreements with other studies or reviews

Other reviews have used broader definitions of CIM andCIP than

this review and they have included participants who are critically

ill or in a very early phase of ICU treatment, or they have de-

scribed interventions forthe prevention of CIM/CIP ( Adler 2012;

Doherty 2010; Kayambu 2013; Koo 2013).

For instance, a recent review about rehabilitation interventions

searched for studies including “adults post-ICU”, but the authors

did not use the definition of ICU-acquired or generalised weak-

ness and defined diagnoses of CIP and CIM (Mehlhorn 2014).



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R E F E R E N C E S

References to studies excluded from this review

Ali 2008 {published data only}∗ Ali NA, O’Brien JM Jr, Hoffmann SP, Phillips G, Garland

A, Finley JC, et al. Acquired weakness, handgrip strength,

and mortality in critically ill patients. American Journal of

Respiratory and Critical Care Medicine 2008;178(3):261–8.

Angelopoulos 2013 {published data only}∗ Angelopoulos E, Karatzanos E, Dimopoulos S, Mitsiou G,

Stefanou C, Patsaki I, et al. Acute microcirculatory effects

of medium frequency versus high frequency neuromuscular

electrical stimulation in critically ill patients - a pilot

study. Annals of Intensive Care 2013;3(1):39. [PUBMED:

24355422]

Berney 2003 {published data only}∗ Berney S, Denehy L. The effect of physiotherapy treatment

on oxygen consumption and haemodynamics in patients

who are critically ill. Australian Journal of Physiotherapy 2003;49(2):99–105.

Brummel 2014 {published data only}∗ Brummel NE, Girard TD, Ely EW, Pandharipande PP,

Morandi A, Hughes CG, et al. Feasibility and safety of early

combined cognitive and physical therapy for critically ill

medical and surgical patients: the Activity and Cognitive

Therapy in ICU (ACT-ICU) trial. Intensive Care Medicine

2014;40(3):370–9. [PUBMED: 24257969]

Burtin 2009 {published data only}∗ Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer

D, Troosters T, et al. Early exercise in critically ill patients

enhances short-term functional recovery. Critical Care

Medicine 2009;37(9):2499–505.

Caruso 2005 {published data only}∗ Caruso P, Denari SD, Ruiz SA, Bernal KG, Manfrin GM,

Friedrich C. Inspiratory muscle training is ineffective in

mechanically ventilated critically ill patients. Clinics (Sao

Paulo) 2005;60(6):479–84.

Delany 2003 {published data only}∗ Delaney CP, Zutshi M, Senagore AJ, Remzi FH, Hammel

J, Fazio VW. Prospective, randomized, controlled trial

between a pathway of controlled rehabilitation with early

ambulation and diet and traditional postoperative care after

laparotomy and intestinal resection. Diseases of the Colon

and Rectum 2003;46(7):851–9.

Denehy 2013 {published data only}∗ Denehy L, Skinner EH, Edbrooke L, Haines K, Warrillow S, Hawthorne G, et al. Exercise rehabilitation for patients

with critical illness: a randomized controlled trial with 12

months of follow-up. Critical Care 2013;17(4):R156.

Derde 2012 {published data only}∗ Derde S, Hermans G, Derese I, Güiza F, Hedström Y,

Wouters PJ. Muscle atrophy and preferential loss of myosin

in prolonged critically ill patients. Critical Care Medicine

2012;40(1):79–89.

Gerovasili 2009 {published data only}∗ Gerovasili V, Stefanidis K, Vitzilaios K, Karatzanos E,

Politis P, Koroneos A, et al. Electrical muscle stimulation

preserves the muscle mass of critically ill patients: a

randomized study. Critical Care (London, England) 2009;13

(5):R161. [PUBMED: 19814793]

Karatzanos E, Gerovasili V, Zervakis D, Tripodaki E-

S, Apostolou K, Vasileiadis I, et al. Electrical muscle

stimulation: an effective form of exercise and early

mobilization to preserve muscle strength in critically ill

patients. Critical Care Research & Practice 2012; Vol.

2012:432752. [PUBMED: 22545212]

Gruther 2010 {published data only}∗ Gruther W, Kainberger F, Fialka-Moser V, Paternostro-

Sluga T, Quittan M, Spiss C, et al. Effects of neuromuscular

electrical stimulation on muscle layer thickness of knee

extensor muscles in intensive care unit patients: a pilot

study. Journal of Rehabilitation Medicine 2010;42(6):593–7.

[: 1650–1977]

Guerin 2004 {published data only}∗ Guerin C, Gaillard S, Lemasson S, Ayzac L, Girard R,

Beuret P, et al. Effects of systematic prone positioning

in hypoxemic acute respiratory failure: a randomized

controlled trial. JAMA 2004;292(19):2379–87.

Jackson 2012 {published data only}∗ Jackson J, Ely EW, Morey MC, Anderson VM, Denne

LB, Clune J, et al. Cognitive and physical rehabilitation

of ICU survivors: results of the RETURN randomized,

controlled pilot investigation. Critical Care Medicine 2012;

40(4):1088-97.

Kho 2012 {published data only}∗ Kho ME, Truong AD, Brower RG, Palmer JB, FanE, Needham DM. Neuromuscular electrical stimulation

for intensive care unit-acquired weakness: protocol and

methodological implications for a randomized, sham-

controlled, phase II trial. Physical Therapy 2012;92(12):

1564–79.

Meesen 2010 {published data only}∗ Meesen RL, Dendale P, Cuypers K, Berger J, Hermans

A, Thijs H, et al. Neuromuscular electrical stimulation

as a possible means to prevent muscle tissue wasting in

artificially ventilated and sedated patients in the intensive

care unit: A pilot study. Neuromodulation 2010;13(4):

315–20.

Muehling 2008 {published data only}∗ Muehling BM, Halter G, Lang G, Schelzig H, Steffen P,

Wagner F, et al. Prospective randomized controlled trial

to evaluate “fast-track” elective open infrarenal aneurysm

repair. Langenbecks Archiv fur Chirurgie 2008;393(3):

281–7. [1435–2451: (Electronic)]

Muehling 2009 {published data only}∗ Muehling B, Schelzig H, Steffen P, Meierhenrich R,

Sunder-Plassmann L, Orend KH. A prospective randomized

trial comparing traditional and fast-track patient care in




12/25

elective open infrarenal aneurysm repair. World Journal

of Surgery. 2009/01/13 2009; Vol. 33, issue 3:577–85.

[0364–2313: (Print)]

Nava 1998 {published data only}∗ Nava S. Rehabilitation of patients admitted to a

respiratory intensive care unit. Archives of Physical Medicine

Rehabilitation 1998;79(7):849–54.

Parry 2012 {published data only}∗ Parry SM, Berney S, Koopman R, Bryant A, El-Ansary

D, Denehy L. Early rehabilitation in critical care (eRiCC):

functional electrical stimulation with cycling protocol for a

randomised controlled trial. BMJ Open 2012;2(5):e001891.

Porta 2005 {published data only}∗ Porta R, Vitacca M, Gilè LS, Clini E, Bianchi L, Zanotti

E, et al. Supported arm training in patients recently weaned

from mechanical ventilation. Chest 2005;128(4):2511–20.

[: 0012–3692]

Poulsen 2011 {published data only}∗ Poulsen JB, Møller K, Jensen CV, Weisdorf S, Kehlet

H, Perner A. Effect of transcutaneous electrical musclestimulation on muscle volume in patients with septic shock.

Critical Care Medicine 2011;39(3):456–61.

Routsi 2010 {published data only}∗ Routsi C, Gerovasili V, Vasileiadis I, Karatzanos E,

Pitsolis T, Nanas S. Electrical muscle stimulation prevents

critical illness polyneuromyopathy: a randomized parallel

intervention trial. Critical Care 2010;14(2):R74.

Schweickert 2009 {published data only}∗ Schweickert WD, Pohlman MC, Pohlman AS, Nigos

C, Pawlik AJ, Esbrook CL, et al. Early physical and

occupational therapy in mechanically ventilated, critically

ill patients: a randomised controlled trial. Lancet 2009;373

(9678):1874–82. [PUBMED: 19446324]

Troosters 2010 {published data only}∗ Troosters T, Probst VS, Crul T, Pitta F, Gayan-Ramirez G,

Decramer M. Resistance training prevents deterioration in

quadriceps muscle function during acute exacerbations of

chronic obstructive pulmonary disease. American Journal

of Respiratory and Critical Care Medicine 2010;181(10):

1072–7.

Zanotti 2003 {published data only}∗ Zanotti E, Felicetti G, Maini M, Fracchia C. Peripheral

muscle strength training in bed-bound patients with

COPD receiving mechanical ventilation: effect of electrical

stimulation. Chest 2003;124(1):292–6.

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C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Ali 2008 Cohort study. Not a RCT

Angelopoulos 2013 Included a mix of participants with and without ICU-acquired weakness; no clear description or confirmed or

probable diagnosis of CIP or CIM

Berney 2003 No description of participants with generalised weakness and a confirmed or probable diagnosis of CIP or

CIM

Brummel 2014 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Burtin 2009 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Caruso 2005 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Delany 2003 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Denehy 2013 Included critically ill participants but did not include people with a confirmed or probable diagnosis of CIP

or CIM

Derde 2012 Not a RCT

Gerovasili 2009 Included critically ill participants but did not include people with generalised weakness and a confirmed or

probable diagnosis of CIP or CIM

Gruther 2010 People with myopathy or neuromuscular disorders were excluded; did not include people with generalised

weakness and a confirmed or probable diagnosis of CIP or CIM

Guerin 2004 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Jackson 2012 Did not include people with weakness and a confirmed or probable diagnosis of CIP or CIM

Kho 2012 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Meesen 2010 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Muehling 2008 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Muehling 2009 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Nava 1998 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Parry 2012 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM




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(Continued)

Porta 2005 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Poulsen 2011 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Routsi 2010 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Schweickert 2009 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Troosters 2010 Did not include people with generalised weakness and a confirmed or probable diagnosis of CIP or CIM

Zanotti 2003 People with myopathy orneurologic conditions were excluded;did notincludepeople with generalisedweakness

and a confirmed or probable diagnosis of CIP or CIM

CIM: critical illness myopathy; CIP: critical illness polyneuropathy; ICU: intensive care unit; RCT: randomised controlled trial




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D A T A A N D A N A L Y S E S

This review has no analyses.

A P P E N D I C E S

Appendix 1. CENTRAL search strategy

#1“randomised controlled trial”:pt (Word variations have been searched)

#2“controlled clinical trial”:pt (Word variations have been searched)

#3randomized:ti,ab,kw (Word variations have been searched)

#4placebo:ti,ab,kw (Word variations have been searched)

#5drug therapy:ti,ab,kw (Word variations have been searched)

#6randomly:ti,ab,kw (Word variations have been searched)

#7trial:ti,ab,kw (Word variations have been searched)

#8groups:ti,ab,kw (Word variations have been searched)#9#1 or #2 or #3 or #4 or #5 or #6 or #6 or #7 or #8

#10MeSH descriptor: [Animals] explode all trees

#11#9 not #10

#12MeSH descriptor: [Polyneuropathies] this term only

#13MeSH descriptor: [Muscle Weakness] this term only

#14MeSH descriptor: [Rhabdomyolysis] this term only

#15MeSH descriptor: [Quadriplegia] this term only

#16MeSH descriptor: [Paresis] this term only

#17neuromuscular manifestation? (Word variations have been searched)

#18(polyneuropath* or myopath*) (Word variations have been searched)

#19polyneuromyopath* (Word variations have been searched)

#20neuromuscular disorder? (Word variations have been searched)

#21neuromuscular disease? (Word variations have been searched)#22paresis (Word variations have been searched)

#23quadriplegia (Word variations have been searched)

#24weakness (Word variations have been searched)

#25neuromyopath* (Word variations have been searched)

#26motor syndrome (Word variations have been searched)

#27muscle function (Word variations have been searched)

#28MeSH descriptor: [Muscle Strength] this term only

#29(muscle strength or respiratory failure) (Word variations have been searched)

#30#12 or #13 or #14 or #15 or #16 or #17 or #18 or #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26 or #27 or #28

#31MeSH descriptor: [Intensive Care] this term only

#32MeSH descriptor: [Critical Illness] this term only

#33intensive care (Word variations have been searched)

#34critical* ill* (Word variations have been searched)#35MeSH descriptor: [Ventilator Weaning] this term only

#36MeSH descriptor: [Respiration, Artificial] this term only

#37#31 or #32 or #33 or #34 or #35 or #36

#38MeSH descriptor: [Electric Stimulation Therapy] this term only

#39electrostimulation (Word variations have been searched)

#40(electric* next/2 stimulation) (Word variations have been searched)

#41((leg or lower) next/2 (limb* or extremit*)) (Word variations have been searched)

#42(#38 or #39 or #40) and #41




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#43MeSH descriptor: [Exercise] explode all trees

#44MeSH descriptor: [Physical Therapy Modalities] this term only

#45physiotherap* or (physical therap*) (Word variations have been searched)

#46MeSH descriptor: [Exercise Therapy] explode all trees

#47MeSH descriptor: [Musculoskeletal Manipulations] this term only

#48MeSH descriptor: [Occupational Therapy] this term only #49MeSH descriptor: [Recovery of Function] this term only

#50MeSH descriptor: [Activities of Daily Living] this term only

#51strength training (Word variations have been searched)

#52muscle training (Word variations have been searched)

#53(physical next/5 rehabilitation)

#54#42 or #43 or #44 or #45 or #46 or #47 or #48 or #49 or #50 or #51 or #52 or #53

#55#11 and #30 and #37 and #54

Date of search: 23 June 2014

Number of records retrieved: 808

Appendix 2. MEDLINE (OvidSP) search strategy

1. randomized controlled trial.pt.

2. controlled clinical trial.pt.

3. randomized.ab.

4. placebo.ab.

5. drug therapy.fs.

6. randomly.ab.

7. trial.ab.

8. groups.ab.

9. or/1-8

10. exp animals/ not humans.sh.

11. 9 not 10

12. Polyneuropathies/

13. Muscle Weakness/

14. Rhabdomyolysis/15. Quadriplegia/

16. Paresis/

17. neuromuscular manifestation$1.tw.

18. (polyneuropath$ or myopath$).tw.

19. polyneuromyopath$.tw.

20. neuromuscular disorder$.tw.

21. neuromuscular disease$.tw.

22. paresis.tw.

23. quadriplegia.tw.

24. weakness.tw.

25. neuromyopath$.tw.

26. motor syndrome.tw.

27. muscle function.tw.28. muscle strength/

29. (muscle strength or respiratory failure).tw.

30. or/12-29

31. Intensive Care/

32. Critical Illness/

33. intensive care.tw.

34. critical$ ill$.tw.

35. ventilator weaning/




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36. respiration, artificial/

37. or/31-36

38. electric stimulation therapy/ or electrostimulation.mp. or (electric$ adj2 stimulation).tw.

39. ((leg or lower) adj2 (limb$ or extremit$)).tw.

40. 38 and 39

41. exp Exercise/42. physical therapy modalities/ or physiotherap$.tw. or physical therap$.tw.

43. exp Exercise Therapy/

44. Musculoskeletal Manipulations/

45. Occupational Therapy/

46. recovery of function/

47. “Activities of Daily Living”/

48. strength training.mp.

49. muscle training.mp.

50. (physical adj5 rehabilitation).tw.

51. or/40-50

52. 11 and 30 and 37 and 51



Appendix 3. EMBASE (OvidSP) search strategy

1. randomized controlled trial.pt.

2. controlled clinical trial.pt.

3. randomized.ab.

4. placebo.ab.

5. drug therapy.fs.

6. randomly.ab.

7. trial.ab.

8. groups.ab.

9. or/1-8

10. exp animals/ not humans.sh.

11. 9 not 10

12. Polyneuropathies/

13. Muscle Weakness/

14. Rhabdomyolysis/

15. Quadriplegia/

16. Paresis/

17. neuromuscular manifestation$1.tw.

18. (polyneuropath$ or myopath$).tw.

19. polyneuromyopath$.tw.

20. neuromuscular disorder$.tw.

21. neuromuscular disease$.tw.

22. paresis.tw.

23. quadriplegia.tw.24. weakness.tw.

25. neuromyopath$.tw.

26. motor syndrome.tw.

27. muscle function.tw.

28. muscle strength/

29. (muscle strength or respiratory failure).tw.

30. or/12-29

31. Intensive Care/




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32. Critical Illness/

33. intensive care.tw.

34. critical$ ill$.tw.

35. ventilator weaning/

36. respiration, artificial/

37. or/31-3638. electric stimulation therapy/ or electrostimulation.mp. or (electric$ adj2 stimulation).tw.

39. ((leg or lower) adj2 (limb$ or extremit$)).tw.

40. 38 and 39

41. exp Exercise/

42. physical therapy modalities/ or physiotherap$.tw. or physical therap$.tw.

43. exp Exercise Therapy/

44. Musculoskeletal Manipulations/

45. Occupational Therapy/

46. recovery of function/

47. “Activities of Daily Living”/

48. strength training.mp.

49. muscle training.mp.

50. (physical adj5 rehabilitation).tw.51. or/40-50

52. 11 and 30 and 37 and 51



Appendix 4. CINAHL (EBSCOhost) search strategy

S56 S11 AND S30 AND S37 AND S55

S55 S43 OR S44 OR S45 OR S46 OR S47 OR S48 OR S49 OR S50 OR S51 OR S52 OR S53 OR S54

S54 TX (physical n5 rehabilitation)

S53 MH muscle training

S52 MH strength training

S51 MH activities of daily living

S50 MH recovery of function

S49 MH occupational therapy

S48 MH Musculoskeletal Manipulations

S47 MW exercise therapy

S46 TX physiotherap* or (physical therap*)

S45 MW physical therapy modalities

S44 MH exercise

S43 S41 AND S42

S42 S38 OR S39 OR S40

S41 TX ((leg or lower) n2 (limb# or extremit*))

S40 TX (electric* N2 stimulation)

S39 TX electrostimulation

S38 MH electric stimulation therapy S37 S31 OR S32 OR S33 OR S34 OR S35 OR S36

S36 MH respiration, artificial

S35 MH ventilator weaning

S34 TX critical* ill*

S33 TX intensive care

S32 MH Critical Illness

S31 MH Intensive Care




21/25

S30 S12 OR S13 OR S14 OR S15 OR S16 OR S17 OR S18 OR S19 OR S20 OR S21 OR S22 OR S23 OR S24 OR S25 OR S26

OR S27 OR S28 OR S29

S29 TX (muscle strength or respiratory failure)

S28 MH muscle strength

S27 TX muscle function

S26 TX motor syndromeS25 TX neuromyopath*

S24 TX weakness

S23 TX quadriplegia

S22 TX paresis

S21 TX neuromuscular disease#

S20 TX neuromuscular disorder#

S19 TX polyneuromyopath*

S18 TX (polyneuropath* or myopath*)

S17 TX neuromuscular manifestation#

S16 MW Paresis

S15 MH Quadriplegia

S14 MH Rhabdomyolysis

S13 MH muscle weaknessS12 MH polyneuropathies

S11 s9 not s10

S10 MW animals

S9 S1 OR S2 OR S3 OR S4 OR S5 OR S6 OR S7 OR S8

S8 AB groups

S7 AB trial

S6 AB randomly

S5 TX drug therapy

S4 AB placebo

S3 AB randomized

S2 MH controlled clinical trial

S1 MH randomized controlled trials

Date of search: 23 June 2014Number of records retrieved: 2666

Appendix 5. NMD Specialized Register (CRS) search strategy

#1 Rhabdomyolysis or Quadriplegia or Paresis or polyneuropath* or myopath* or polyneuromyopath* or weakness or neuromyopath*

[REFERENCE] [STANDARD]

#2 “neuromuscular disorder*” or “neuromuscular disease*” [REFERENCE] [STANDARD]

#3 neuromuscular NEXT manifestation* [REFERENCE] [STANDARD]

#4 “ motor syndrome” or “muscle function” or “muscle strength” [REFERENCE] [STANDARD]

#5 “muscle strength” or “respiratory failure” [REFERENCE] [STANDARD]

#6 “muscular atrophy” or “muscle wasting” [REFERENCE] [STANDARD]

#7 #1 or #2 or #3 or #4 or #5 or #6 [REFERENCE] [STANDARD]

#8 “Intensive Care” [REFERENCE] [STANDARD]#9 “Critical Illness” or “critically ill”or “intensive care” or “ventilator weaning”or “artificial respiration” [REFERENCE] [STANDARD]

#10 MeSH DESCRIPTOR Respiration, Artificial [REFERENCE] [STANDARD]

#11 #8 or #9 or #10 [REFERENCE] [STANDARD]

#12 electrostimulation or electric* NEAR2 stimulation [REFERENCE] [STANDARD]

#13 rehabilitation or “breathing exercise” or “breathing exercises” [REFERENCE] [STANDARD]

#14 MeSH DESCRIPTOR Physical Therapy Modalities Explode All [REFERENCE] [STANDARD]

#15 “recovery of function” or convalescence [REFERENCE] [STANDARD]

#16 MeSH DESCRIPTOR Physical Stimulation Explode All [REFERENCE] [STANDARD]




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#17 “resistance training” or “exercise therapy” or “physical therapy” or physiotherapy [REFERENCE] [STANDARD]

#18 “occupational therapy” or training or “muscle stimulation” [REFERENCE] [STANDARD]

#19 #12 or #13 or #14 or #15 or #16 or #17 or #18 [REFERENCE] [STANDARD]

#20 #7 and #11 and #19 [REFERENCE] [STANDARD]

#21 (#7 and #11 and #19) AND (INREGISTER) [REFERENCE] [STANDARD]

#22 #11 and #19 [REFERENCE] [STANDARD]

Appendix 6. ClinicalTrials.gov search strategy

#1 critic* ill*

#2 critical illness myopathy

#3 critical illness neuropathy

#4 critical illness neuromyopathy

#5 #1 OR #2 OR #3 OR #4

Date of search: 8 July 2014


Appendix 7. ICTRP search strategy

Advanced search:critic* AND ill* in the title;

myo* OR neuro* OR neuromyo* in the condition

Date of search: 08 July 2014


Appendix 8. Additional methods

We described the following methods in the protocol for this review (Mehrholz 2014a ).


Data extraction and management

We proposed that two authors (MP and JM) would extract outcome data from the selected trials independently using a data collection

form. If one of the review authors was involved in an included trial, another review author would extract data from this trial.

The review authors proposed to extract the following data (according to the Cochrane Handbook for Systematic Reviews of Interventions Table 7.3.a):

1. source;

2. eligibility;

3. participants (important imbalances in prognostic factors at baseline, country, number of participants, age, gender, inclusion and

exclusion criteria, educational background, socioeconomic status, cognition, pre-existing neurological impairment(s), neurological

history);

4. interventions;

5. outcomes and measurement time point;

6. comparison (details of interventions in treatment and control groups, duration of treatment, details of co-intervention in thegroups;

7. results;

8. funding source and conflicts of interest among investigators; and

9. miscellaneous.

Two review authors (MP and JM) would have checked the extracted data for agreement. If they had not been able to reach a consensus,

a third review author would have arbitrated.

If necessary, the review authors would have contacted trial authors for more information. We planned to report the outcome of efforts

to source missing data in the review.




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Data synthesis

We proposed using a random-effects model, regardless of the level of heterogeneity found with the I2 statistic. Thus, in cases of

heterogeneity, we would not have violated the preconditions of a fixed-effect model approach.

If the review had included more than one comparison, which could not be included in the same analysis, we would have reported the

results for each comparison separately.

’Summary of findings’ table

We planned to use GRADEpro software to create a ’Summary of findings’ table with the following outcomes: activities, muscle strength,

quality of life and adverse effects (GRADEpro 2014). The planned time points for all outcomes in the ’Summary of findings’ table

were immediately after the intervention and at follow-up one year later. We planned to use the five GRADE considerations (study

limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the quality of a body of evidence (studies that

contributed data for the prespecified outcomes). We would have used the methods and recommendations described in Chapter 12 of

the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). We would have justified all decisions to down- or up-grade the quality of evidence using footnotes.

Subgroup analysis and investigation of heterogeneity

We proposed three subgroup analyses as follows:1. Duration of illness or critical condition: acute/subacute phase (first six months of initiated intervention) versus chronic phase

(illness of more than six months’ duration and interventions initiated accordingly).

2. Use of definitions of CIP and CIM: use of definitive definition of CIP and CIM in studies versus use of probable definition.

3. Imbalance of prognostic factors at baseline (such as age, duration of illness and duration of ventilation).

We would have considered meta-regression as an extension to subgroup analyses when there were more than 10 studies in a meta-

analysis.

Sensitivity analysis

If a sufficient number of studies had been identified we planned to test the robustness of results by conducting a sensitivity analysis,

removing studies at high or unclear risk of bias (for example, high or unclear versus low risk of bias from method of randomisation).

C O N T R I B U T I O N S O F A U T H O R S

All authors contributed to the conception and design of the protocol and approved the final text. All authors were involved in all stages

of the review. JM screened titles and abstracts of publications identified by the searches. MP and JM would have extracted trial and

outcome data from the selected trials and analysed outcome data. JK and MP would have assessed the risk of bias in included studies.

D E C L A R A T I O N S O F I N T E R E S T

Jan Mehrholz: none known.

Marcus Pohl: none known.

Joachim Kugler: none known.

Jane Burridge: none known.

Simone Mückel: none known.

Bernhard Elsner: none known.




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S O U R C E S O F S U P P O R T

Internal sources

• Wissenschaftliches Institut, Private Europäische Medizinische Akademie der Klinik Bavaria in Kreischa GmbH, An

derWolfsschlucht 1-2, 01731 Kreischa, Germany.• Lehrstuhl Therapiewissenschaften, SRH Fachhochschule für Gesundheit Gera gGmbH, Hermann-Drechsler-Str. 2, 07548

Gera, Germany.

• Gesundheitswissenschaften/Public Health, Medizinische Fakultät Carl Gustav Carus der TU Dresden, Fetscherstr. 74, 01307

Dresden, Germany.

• University of Southampton, UK.

External sources

• No sources of support supplied

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E WDue to the lack of included studies, we were unable to implement many of our proposed methods.



Polineuropatía Paciente Critico Cochrane 2015

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