Indirect approaches: A systematic review of paediatric ...

Edith Cowan UniversityResearch Online

Theses : Honours Theses

2015

Indirect approaches: A systematic review ofpaediatric dysphagia interventionsBianca PianoEdith Cowan University

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Recommended CitationPiano, B. (2015). Indirect approaches: A systematic review of paediatric dysphagia interventions. Retrieved from https://ro.ecu.edu.au/theses_hons/1486

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Indirect Interventions i

Indirect Approaches: A Systematic Review of Paediatric Dysphagia Interventions

Bianca Piano

A report submitted in Partial Fulfilment of the Requirements for the Award of Bachelor

of Speech Pathology with Honours, Faculty of Computing, Health and Science,

Edith Cowan University.

Submitted (November, 2015)

I declare that this written assignment is

my own work and does not include:

(i) material from published

sources used without proper

acknowledgement; or

(ii) (ii) material copied from the

work of other students.

Signature: _____________________

Date: 16th November 2015

Indirect Interventions ii

Abstract

Background and purpose: Dysphagia can be described as difficulty within the oral,

pharyngeal and/or oesophageal phases of deglutition and occurs in approximately 80% of

children with developmental disabilities, according to the American Speech and Hearing

Association (2015). It occurs when there is impairment to the motor and/or sensory

aspects of swallowing, due to a range of disorders affecting the voluntary and reflexive

components of deglutition. The ability to swallow safely is essential in preventing

medical complications, sustaining life and maintaining social participation. Paediatric

interventions can be categorized into three broad approaches; direct, indirect and mixed.

At present, two systematic reviews have examined the efficacy of direct interventions.

Despite a large body of evidence supporting the efficacy and safety of indirect paediatric

dysphagia interventions, no studies have systematically grouped and compared the

relative effectiveness of indirect interventions, across all paediatric ages and conditions.

Methods and procedure: Following a comprehensive search of 19 databases by two

independent searches and using an identical search strategy, a systematic review

appraised 13 randomized and non-randomized control studies relating to indirect

paediatric dysphagia interventions. Based on retrieved results, indirect interventions

included modified equipment, environmental changes and altered rate of food and liquid

presentation. Articles included in the analysis were rated for quality on two separate

appraisal scales; The Cochrane Risk of Bias Tool and the Pedro Scale. Additionally,

effect size calculations and forest plots were derived to standardize and compare the

effects of individual intervention types.

Outcomes and results: The review demonstrated that whilst a lack of high quality

evidence exists in the field of paediatric dysphagia, the available RCTs are of high

methodological quality. Overall, effect size calculations demonstrate a positive trend

Indirect Interventions iii

towards improved feeding, anthropometric measures and length of hospital stay outcomes

for interventions involving modified equipment, environmental changes and altered rate

of presentation.

Conclusions: The available RCT evidence involving indirect interventions are of high

methodological quality. As effects of these interventions demonstrate positive outcomes,

Speech Pathologists should continue to implement these interventions within everyday

practice. To further validate the effects of indirect management approaches, additional

high quality research is required.

Key words: paediatric dysphagia, indirect management, intervention,

systematic review

Author: Bianca Piano

Supervisors: Dr. Charn Nang and Ms. Abigail

Lewis

Indirect Interventions iv

COPYRIGHT AND ACCESS DECLARATION

I certify that this thesis does not, to the best of my knowledge and belief;

(i) Incorporate without acknowledgement any material previously submitted for

degree or diploma in any institution of higher education;

(ii) Contain any material previously published or written by another person except

where due reference is made in the text;

(iii) Contain any defamatory material.

Signed: _________________________

Date: 16th November 2012

Indirect Interventions v

Acknowledgements

I would like to thank my Principle Supervisor Dr. Charn Nang for her guidance and

creativity throughout this project. A big thank-you to my Secondary supervisor Abigail

Lewis who has been so open to learning the methodology behind systematic reviews. You

have both been incredibly generous with your time and knowledge, and I am

exceptionally grateful for the direction you have provided.

A special thanks to Maria Woodhouse and Karen Lycett for their hard work devising the

search strategy and taking on the role of a search team. I would also like to mention

Jacqui Coombes for her statistical expertise. A big congratulations to my fellow Honors

students Ildi Bruz, Stacey Osborne and Theresa Huth, thank you for everything.

I would like to mention Timothy Chaney for supporting my studies and always listening.

Lastly, I would like to thank my Mum, Colleen Piano, to whom I dedicate this project.

You have always encouraged me to read, learn and keep going.

Indirect Interventions vi

Table of Contents

Introduction………………………………………………………………………..1

Significance of Paediatric Dysphagia.……………..………………………..1

Contribution to Evidence Based Practice….………………………………4

Management: Who and Where…….………………………………………4

Description of Interventions……….………………………………………5

Why it is Important to Conduct this Review….…………………………...9

Research Aims……………………………………………………………10

Method……………………………………………………………………………11

Research Design…………………………………………………………..11

Criteria for Considering Reviews for Inclusion...………………………...11

Search Methods for Identification of Reviews……………………………12

Data Collection and Analysis……………………………………………..14

Assessment of Methodological Quality for Included Studies…………….14

Data Synthesis…………………………………………………………….15

Results.....................................................................................................................16

Included Studies…………………………………………………………..18

Outcome Measures………………………………………………………..26

Quality Appraisal…………………………………………………………29

Reported Effects of Intervention and Data Synthesis…………………….38

Discussion………………………………………………………………………...42

Quality of Evidence……………………………………………………….42

Effects of Interventions……………………………………………………45

Potential Bias in the Review Process……………………………………...47

Implications for Research............................................................................49

Implications for Practice…………………………………………………..50

Conclusion………………………………………………………………...51

References................................................................................................................53

Appendix A..............................................................................................................64

Appendix B..............................................................................................................65

Appendix C……….… …………………………………………………………….66

Appendix D..............................................................................................................67

Appendix E …….……...…………………………………………………………..68

Appendix F….……………………………………………………………………..69

Appendix G….…………………………………………………………………….70

Appendix H….…………………………………………………………………….74

Appendix I…….…………………………………………………………………...76

Indirect Interventions 1

Indirect Approaches: A Systematic Review of Paediatric Dysphagia Interventions

Dysphagia refers to an inability or difficulty with either the motor or sensory

aspects of swallowing (Lamm, Felicia, & Cargo, 2005), and occurs as a result of

impairment to the structures involved in the oral, pharyngeal and/or oesophageal phases

of deglutition (Arvedson & Brodsky, 1993). The American Speech and Hearing

Association (ASHA, 2015) distinguishes swallowing and feeding disorders, categorizing

feeding disorders as a group of eating behaviours which may or may not be accompanied

by difficulty swallowing food and liquid. In children, disordered behaviors may include

difficulty accepting age-appropriate liquids or foods, not using appropriate feeding

devices, being unable to feed independently, food refusal and accepting a restricted

variety or quantity of food and liquid (ASHA, 2015).

Both dysphagia and feeding disorders are symptoms of various conditions

(Cichero & Murdoch, 2006) and are common in children with chromosomal, neurological

or anatomic abnormalities (Al-Sayed, Schrank, & Thach, 1994).

Few rigorous epidemiological reports of dysphagia prevalence are available for

populations of children, however one study estimates the incidence of feeding and

swallowing disorders to be 25–45% of typically developing children and up to 80% of

children with developmental disabilities (Linscheid, 2006).

Significance of paediatric dysphagia

Paediatric dysphagia is caused by impairment to the body structures and functions

associated with swallowing and feeding (Snider, Majnemer, & Darsaklis, 2011), and has

subsequent effects on everyday activity and participation (World Health Organisation’s

International Classification of Disability, Functioning and Health: ICF, 2001).


Body structure and function. Following damage to cortical areas controlling

swallowing processes, the major health consequences of dysphagia include malnutrition,

dehydration (Kovar, 1997), failure to thrive (Hawdon, Beauregard, & Kennedy, 2000),

poor growth, delayed development and respiratory damage (Barbosa, Gomes, & Fischer,

2014).

In the oral phase of swallowing, impairment of cranial nerves V (trigeminal), VII

(facial) and XII (hypoglossal) (Cichero & Murdoch, 2006) may result in poor lip closure,

tongue mobility, sucking, chewing and oral transition of the bolus (Morgan, Dodrill &

Ward, 2012).

During the pharyngeal phase, cranial nerves IX (Glossopharyngeal) and X

(Vagus) (Cichero & Murdoch, 2006) may fail to invigorate causing inadequate

pharyngeal peristalsis, laryngeal elevation and excessive pooling of food or fluid in the

valleculae or pyriform sinuses (Cichero & Murdoch, 2006). This may result in aspiration,

where the supporting structures fail and there is inadequate epiglottal seal to protect the

airway, ineffective closure of the true and false vocal folds (Glass & Wolf, 1999) and/or

incoordination of swallowing and respiration (Cichero & Murdoch, 2006). Food may be

misdirected into the lungs (Lau & Smith, 2012), where respiratory rate, oxygen saturation

and overall lung development can become compromised (De Rosa Barbosa, Gomes, &

Gilberto, 2014).

In the esophageal phase, impairment of cranial nerve X (Vagus) may affect bolus

movement through the oesophagus into the stomach via peristalsis (Cichero & Murdoch,

2006).

Dysphagia may also be associated with health and nutritional compromise (Kovar,

1997). Additionally, secondary effects include increased irritability, decreased motivation

and reduced energy available for developmental activities such as play and rehabilitation


(Sullivan et al., 2000). As such, Clawson, Kuchinski and Bach (2007) argue paediatric

dysphagia can be associated with a decrease in cerebral function and the exacerbation of

existing neurological impairments.

Activity and participation. According to the ICF (WHO, 2001), activities and

participation refer to an individual’s functional status. Children with dysphagia may be

limited in their ability to participate appropriately in mealtime activities (e.g., sitting at a

dinner table or adhering to socially normed mealtime behaviours) (Threats, 2007).

Additionally, as the act of eating and drinking is an important aspect of socialisation,

children may miss out on the ability to engage in food related opportunities (e.g., birthday

parties, culturally determined meals and meal time engagement). As such, children with

dysphagia may be restricted in their ability to participate in life situations (WHO, 2001)

and their ability to build relationships with family and friends can be compromised

(Snider et al., 2011). This is highlighted in a case study of a 15 year old girl who returned

to school following persistent dysphagia one year after a traumatic brain injury; the

adolescent was left socially isolated from peers during lunch because she needed to

receive non-oral feeds from the school nurse (Morgan, Ward, & Murdoch, 2004).

Research suggests the effects of dysphagia can affect an individual’s personal and

contextual modalities. For example, Anand & Scalzo (2000) argue negative, early feeding

experiences are associated with anxiety and stress. Additionally, a qualitative analysis

which sought the experiences of parents caring for children with dysphagia found that the

emotional, financial and physical burdens of caring to significantly impact the emotional

and physical well-being of parents (Cowpe-Jebson, Hanson, & Smith, 2014).


Contribution to evidence based practice (EBP)

As paediatric dysphagia can impact each aspect of individual functioning, it is

important to understand effective management approaches. EBP has a role in developing

effective treatment approaches to health conditions. It is defined as the “conscientious,

explicit, and judicious use of current best evidence in making decisions about the care of

individual patients by integrating individual clinical expertise with the best available

external clinical evidence from systematic research” (Sackett, Rosenburg, Gray, Haynes

& Richardson, 1996, p.71). According to the evidence base hierarchy, various

methodologies contribute to EBP, but systematic reviews and meta-analysis comprise best

evidence (Sackett et al.).

Effective dysphagia management can target and improve individual functioning

across all aspects of the ICF. As such, the aim of management is to enhance individual

body structures and function, activity, and participation by advancing nutritional status,

physical, cognitive and psychological growth, as well as the interactions between child

and family (Arvedson, 2008). Moreover, obtaining evidence from studies designed to

answer questions about clinical practice improves management by setting new, verifiable

standards about what constitutes suitable intervention (Lass & Pannbacker, 2008).

Making well-informed decisions based on clinically relevant and systematic research is

important for minimizing harm to clients and potentially shaping health policy (Sackett et

al., 1996).

Management: who and where

As swallowing is a complex developmental process, the need for intervention is

highlighted in research (e.g., Lau & Hurst, 1999). It is important that qualified

professionals manage children with dysphagia appropriately. Speech Pathologists are

recognized by ASHA (2015) as the primary professionals involved, and “should lead both


the assessment and planning” of intervention (New Zealand Guideline Group, 2006,

p.83).

Additionally, current research advocates multidisciplinary management amongst

Speech Pathologists, Nurses, Occupational Therapists, Dieticians and Paediatricians

(Arvedson, 2008; Cowpe-Jebson et al. 2014; Miller, 2001; Siktberg & Bantz, 1999).

Typically, children present with multiple medical, developmental and nutritional

concerns; therefore, collaboration from different disciplines allows for coordinated care,

which focuses on the whole child (Arvedson, 2008).

Due to the variability in age and severity of feeding and swallowing dysfunction,

children are seen in various settings (Arvedson, Clark, Lazarus, Schooling & Frymark,

2010a). For example, children may receive early intervention in acute and rehabilitation

settings. Once children reach school age, they may receive care from specialist Nurses

and Speech Pathologists (Angell, Bailey, & Stoner, 2008).

Description of interventions

A range of intervention strategies have been developed to improve the efficiency

and safety of paediatric dysphagia management (Arvedson, 2008). These interventions

can be broadly categorized into three approaches: direct, indirect and mixed.

Direct. Direct management techniques target physiological impairments (WHO,

2001) across the oral and pharyngeal phases of swallowing, and refer to stimulation,

which enhances neuromuscular control and strength (Logemann, 2000). Oral-motor

exercises, exploration, stimulation and swallowing manoeuvres (Logemann, 2000) are

used to facilitate lip closure, tongue lateralization and oral strength, whilst decreasing

tactile hypersensitivity (Ganz, 1987; Helfrich-Miller, Rector & Straka, 1986). The

underlying principle of oral-motor exercises is that by stimulating the oral structures for

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function, greater opportunities to practice feeding skills occur (Ganz, 1987), abnormal

reflexes diminish and oral-pharyngeal timing and coordination improves (Snider et al.,

2011).

Impairment-level interventions are supported by a growing body of current

evidence. For example, two systematic reviews (Arvedson et al., 2010a; Arvedson, Clark,

Lazarus, Schooling & Frymark, 2010b) reported promising findings following the

appraisal of direct interventions. Additionally a number of randomized control trials

report positive effects; both Arvedson and colleagues (2010a) and Pinelli and Symington

(2005) observed positive effects following a nonnutritive sucking program, including

improved oral feeding, swallowing physiology and decreased transition time to total oral

feeding following a non-nutritive sucking program. Similarly, Fucile, McFarland, Gisel,

and Lau (2012) found sensorimotor intervention enhanced nutritive sucking and swallow–

respiration coordination in pre-terms infants. This is supported by Kamhawy and

colleagues’ (2014) study of preterm infants who saw significantly higher oxygen

saturation, accelerated transition to nipple feeding, greater weight gain and earlier

discharge following a sensorimotor intervention. Finally, Bache, Pizon, Jacobs, Vaillant

and Lecomte’s (2014) RCT of preterm infants found a pre-feeding oral stimulation

program improved breastfeeding at discharge.

Indirect. Indirect techniques refer to interventions that do not directly stimulate

the oral mechanisms for swallowing (Arvedson & Brodsky, 1993) but enhance

swallowing through compensatory strategies which improve activity and participation

limitations or modify environmental factors (WHO, 2001). Examples of indirect

interventions are listed below:

Adapted feeding equipment that is used to control liquid flow and bolus size. One

RCT found bottle type to impact rate of milk transfer and oral feeding duration in

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very-low-birth-weight infants (Fucile, Gisel, Schanler & Lau, 2009). Additionally,

in a second RCT of 522 infants, Yilmaz, Caylan, Karacan, Bodur and Gokcay

(2014) found cup feeding to significantly increase the likelihood of preterm

infants being exclusively breastfed at discharge, without increasing length of

hospital stay.

Diet modifications are used to support swallow physiology by enhancing the

timing, coordination and sensory input of food and liquid by altering viscosity,

texture, temperature, or taste. Evidence indicates that for children with cerebral

palsy "softer food consistencies enhance feeding safety and efficiency" (Snider et

al. 2011, p.72).

Altering rate of presentation includes pacing and cue based strategies, which

control the rate of food presentation and intake. One RCT showed a semi-demand

method promoted faster attainment of oral feeding without compromising weight

gain amongst 89 infants (McCain, Gartside, Greenburg & Lott, 2001).

Prostheses refer to specifically molded feeding plates which are inserted into the

oral cavity to minimize defects and prevent regurgitation of food into the nasal

cavity (Ravichandra, Vijayaprasad & Suzan, 2010). Although there are a large

number of single case studies documenting the successful use of prostheses in

children with cleft and lip palate (Agarwal, Rana, & Shafi, 2010; Bansar et al.

2012; Chandna, Adlakha, & Singh, 2011; Erkan, Karacay, Atay, & Gunay, 2013)

one RCT investigating the effect of orthopaedics observed no improvement in

feeding efficiency or general body growth (Masarei, Wade, Mars, Sommerlad &

Sell, 2007).

For children who cannot achieve safe swallowing or adequate nutrition and

hydration, alternative avenues of intake may occur (e.g., nasogastric tube,




transpyloric tube or gastrostomy) (ASHA, 2015). Current evidence suggests that

for children with neuromuscular weakness, gastrostomy feeding can improve and

maintain adequate nutrition (Hull et al., 2012). However, Wilken (2012) argues

tube feeding is associated with trauma, decreased normalcy and aversive parent-

child relationships.

Postural modifications improve oropharyngeal musculature, protect the airway

and offer safe transit of food and liquid by adjusting the child’s position during

feeding. A systematic review conducted by Snider et al. (2011) identified that for

children with cerebral palsy, "positioning has a positive effect on feeding safety

and efficiency by decreasing the risk of aspiration and diminishing meal time" (p.

71).

To promote a relaxed infant feeding experience, environmental changes promote

feeding by altering the temperature, light or noise in the child’s immediate feeding

environment (Morgan et al., 2012). Evidence from White-Traut et al. (2002) saw

increased alertness, milk intake and earlier discharge following an auditory,

tactile, visual, and vestibular intervention used on 12 preterm infants.

Behavioral approaches are based on principles of behavioral modification and

focus on the presentation of contingencies, shaping, prompting, modeling,

stimulus fading, and antecedent manipulation. Current evidence indicates that

behavioral interventions are associated with significant improvements in feeding

behavior (Sharp, Jaquess, Morton, & Herzinger, 2010).

Mixed. A mixed approach to dysphagia combines a direct and indirect

intervention (Siktberg & Bantz,1999). Mixed approaches are supported by Wilkins,

Piazza, Groff, and Vaz (2011), who found chin prompting plus representation of food

stimuli reduced rates of expulsion in all participating children. Furthermore, Yildiz and

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Arikan (2012) saw positive effects on oral feeding, sucking success and vital signs (peak

heart rate and oxygen saturation) when offering pacifiers to premature infants whilst

playing lullabies during their transition to oral feeding.

Why it is important to conduct this review

Traditionally, the focus of dysphagia literature has been on adult management.

However, anatomical and functional differences to do with swallowing between adults

and children mean adult interventions may not always be appropriately applied to

paediatric populations (Lefton-Greif & Arvedson, 2007). As can be seen in the examples

of the management types presented in the previous section, current methodology

appraising all indirect interventions varies between single cases, cohort studies, quasi

randomized control trials and randomized control trials.

The current literature demonstrates that there are a large number of peadiatric,

indirect intervention studies across all levels of the evidence base hierarchy, including

some systematic reviews and meta analyses. However, the systematic reviews conducted

have either examined a specific population or condition (e.g., preterm infants [Daley &

Kennedy, 2000] or cerebral palsy [Snider et al. 2011]), or have summarized a single

intervention type only (e.g., thickened fluids [Gosa, Schooling & Coleman, 2011],

alternative avenues of intake [Watson & Mcguire, 2013] and pacing [McCormick, Tosh,

& McGuire, 2010]). Although some aspects of indirect interventions have been

systematically reviewed and there is evidence supporting the use of individual strategies

in paediatric settings across case and cohort studies, randomised control trials and some

systematic reviews, to the author’s knowledge, research is yet to group, appraise and

compare the treatment evidence and effects of all indirect approaches within a single

systematic review. In addition to providing a convenient tool for clinicians, collapsing


evidence from various conditions and interventions in a single study offers a valuable

contribution to the literature by ensuring consistent methodology is used when drawing

comparisons about treatment effects.

In order to determine if a specific intervention type is effective and to make

comparisons among the effectiveness of different intervention types, a systematic review

will strengthen the availability of current evidence by appraising evidence quality and

examining the effects of pediatic dysphagia intervention. According to the evidence

hierarchy, systematic reviews and meta-analyses form the highest level of evidence based

practice, therefore, investigations using this methodology are needed to further determine

how children with dysphagia are best managed.

Research aims

This project aims to:

conduct a systematic review of indirect approaches for the management of

paediatric dysphagia;

establish the quality of the evidence for indirect paediatric dysphagia approaches;

and,

calculate effect sizes to determine the effects of indirect approaches and draw

comparisons between different types of indirect interventions.

This project aims to answer the following research questions:

(i) What is the current quality of evidence for indirect management of paediatric

dysphagia?

(ii) What is the treatment effect of indirect approaches?


Method

Research Design

To answer the research questions posed, a systematic review was used to map the

current literature and “identify, appraise and synthesize” (Petticrew & Roberts, 2006, p.9)

the quality of all relevant studies. The current review followed the Cochrane method,

which is recognised as the highest standard in delivering systematic reviews related to

evidence-based health care (Higgins, Green, & Cochrane Collaboration, 2008).

Criteria for considering reviews for inclusion

Types of studies. In order that methodological quality could be rated using the

Cochrane Risk of Bias Tool (CROBT) (Appendix A) and the Pedro scale (PS) (Appendix

B), between groups, randomised controlled trials (RCTs) and quasi-randomised trials

(e.g., where participants were allocated according to order) were considered for review.

Studies were required to have a control group or comparison intervention to be included

for rating on the CROBT and PS.

Types of participants. Participants for inclusion were children aged from birth to

18 years with a developmental delay, disability, or condition that affects swallowing and/

or feeding.

Types of interventions. Articles involving indirect interventions for the

management of swallowing and feeding were considered for review.

Outcome measures. To be considered for review, articles had to contain at least

one outcome measure involving a feeding or swallowing behavior relating to body

structure and function, activity, participation or environmental change (Appendix C).

Search methods for identification of reviews

To determine a comprehensive and sensitive search strategy, two specialist

http://community.cochrane.org/about-us/evidence-based-health-care


Librarians were consulted prior to commencing the review. Based on a previous literature

search conducted by the author, a list of terms was generated relevant to the proposed

research aims. Following consultation with the Librarians, the following search strategy

was developed according to the PICO (Population Intervention Comparison Outcomes

Study) method. Two independent search teams used the search strategy below (Table 1.)

between May and July 2015. To retrieve a wide range of results during the search phase,

the search was not limited by publication date or language.

Table 1. Search Strategy

PICO Search

order Key words

P: paediatric S1 child* OR pediatric* OR paediatric* OR infan*

P: dysphagia S2 dysphagia OR swallowing OR deglutition OR feeding OR

feeding disorder*

P: feeding S3 feeding OR feeding disorder*

I: speech pathology S4 speech path* OR speech language path* OR speech therap*

OR intervention* OR therap*

C: speech

pathology

S5 intervention* OR therap*

O: study S6 trial OR study OR RCT OR randomized control trial OR

clinical OR evidence based

PICO S7 S1+S2+S3+S4+S5+S6

Electronic searches. Published and unpublished literature was searched across 19

electronic databases (see below). Each database was searched using the same search

strategy (Table 1.)

EBSCO

EBSCO: Medline

EBSCO: PsychINFO

EBSCO: ERIC


EBSCO: Education Source

Web of Science

Scopus

SpeechBite

The Joanna Briggs Institute

ProQuest Central

TRIP

Current Controlled Trials

ClinicalTrials.gov

WHO ICTRP

NDLTD

TROVE

DART

ProQuest Dissertations and Theses Global: Health and Medicine

Handsearching. To identify additional studies not picked up in the electronic

search, handsearches of the reference lists of included studies and relevant papers was

conducted at a later date.

Data collection and analysis

Selection of studies and data extraction. The inclusion criteria (discussed above)

were used as a checklist by a primary and one of the two secondary authors (secondary

authors reviewed half of the articles each) to independently determine the appropriateness

of articles. Both raters used a preliminary data extraction form (Appendix D) to collect

information about the inclusion criteria each study met, based on titles. In the first round

of evaluation, there was disagreement over whether 21 titles met the inclusion criteria;


however, this reflected rater inexperience regarding the search confines, and raters were

able to form a consensus by discussing the search strategy and re-evaluating

methodological quality in light of the search parameters. For articles that met preliminary

inclusion criteria, raters used the same preliminary data extraction form (Appendix D) to

evaluate the abstracts and full texts of these preliminary citations in more detail. No

further discrepancies were encountered in the second round of evaluation.

Assessment of methodological quality for included studies

Risk of bias was assessed by rating intervention articles on the CROBT and PS.

For included articles (discussed in the Results section), the primary author rated all

articles and two secondary raters rated half each. The CROBT was used to rate articles as

having a low, high or unclear risk of bias across the following domains: sequence

generation, allocation concealment, blinding, incomplete data, selective outcome

reporting and other sources of bias (Higgins, 2011). Similarly, the PS examined bias by

requiring raters to answer yes or no on the following criterions: specified eligibility

criteria, random allocation of subjects to groups, groups are at similar baselines regarding

the most important prognostic indicators, blinding of subjects, blinding of administering

therapists, blinding of assessors, measure of at least one key outcome were obtained from

more than 85% of subjects initially allocated to groups, all subjects received the treatment

or control condition as allocated, results of between group statistical comparisons are

reported for at least one key outcome and both point and variability measures are

provided for at least one key outcome. For both tools, the quality of included studies were

presented in data extraction tables (Appendix E and F), where a risk judgement was made

in accordance with the decision making guidelines provided by each tool (Higgins, 2011;

Physiotherapy Evidence Database, 1999).


Whilst both tools aim to evaluate methodological quality and assess similar points

of bias, each have limitations (for example, the CROBT fails to account for important

markers of bias including eligibility criteria of participants, participant baselines at the

commencement of trials, between group statistical comparisons and the inclusion of

variability measures, whilst the PS neglects selective reporting and does not offer raters

the opportunity to record “other biases” which may be evident within studies). Therefore,

it was decided that both tools would be used to provide an additional measure of

reliability. The PS was chosen due to its in depth, 11 point bias examination, whilst the

CROBT was used due its option of an “unclear” rating which provides raters with an

alternative to “low” or “high risk” when an article fails to provide details about a

criterion. For ratings that did not attain full agreement from all raters, discrepancies were

discussed until agreement was achieved. Throughout rating, four discrepancies between

raters were encountered on the CRBT (relating to adequate sequence generation,

allocation concealment, selective outcome reporting and other bias). There was one

discrepancy on the PS (relating to agreement on whether there was blinding of all

therapists who administered the therapy).

Data synthesis

Once PS and CROBT quality ratings were complete, frequency data for

each item was collated to represent the overall quality of evidence across all

interventions, specific interventions and populations. The Cochrane GRADE (Grades of

Recommendation, Assessment, Development and Evaluation Working Group) approach

(Higgins, Green, & Cochrane Collaboration, 2008) is based on factors that are considered

to decrease research quality and includes (i) limitations in design and implementation; (ii)

indirectness of evidence; (iii) unexplained heterogeneity; (iv) imprecision of results; (v)


high probability of publication bias; and was used to provide an overall indication of

research quality by standardising various types of bias. Graphs created in Microsoft Excel

were used to represent frequency data.

Additionally, a statistician was consulted to standardise treatment outcomes by

calculating effect sizes for each reported outcome within each included intervention

article. Effect size calculations were based on descriptive measures (means and standard

deviations) across treatment and control conditions, as reported within intervention

articles (Borenstein, Hedges, Higgins, & Rothstein, 2009). Effect size was represented by

Hedges g (g), and was derived from algorithms and interpretation instructions reported in

Borenstein and colleagues (2009). Forest plots were used to visually represent effect size

and were developed using a free forest plot tool created by Bailey (2009). Due to the large

variation in study outcomes, studies were not deemed comparable (Borenstein et al.,

2009) and therefore a meta-analysis was not possible.

Results

The search retrieved a total of 1398 articles (derived across both search teams).

After 83 duplicates were removed, 1315 articles were excluded based on title. 91 articles

met the preliminary inclusion criteria. The abstracts and full texts of these preliminary

articles were evaluated in more detail against the inclusion criteria and 9 articles met all

of the criteria. Four additional articles were included following a hand search of all

initially included articles. A flow diagram of the study selection process is presented in

Figure 1.


Figure 1. Flow diagram outlining search process.

Included studies

Thirteen articles were included in the final analysis. Table 2 shows the

characteristics of included studies.

Study designs. All included articles were between groups, randomised or quasi-

randomised control trials. Eleven articles comprised one intervention and one-control

group. Two studies were comprised of two intervention groups and one control group

(Collins et al., 2004; Standley et al., 2010).

Identification of evidence gap, search strategy and inclusion/ exclusion criteria

Two search teams review 19 electronic data bases

Title screen of results from search teams (1398

articles) Exclusion of 83 duplicates

Exclusion of 1307 results (irrelevant/ did not meet

inclusion criteria)

Review of 91 preliminarily included abstracts

and full text articles

82 articles further excluded for one or more of the

following: children did not serve as main participants,

no direct speech pathology application, single/ case

study or between measures design, children did not

have a swallowing disorder

Quality appraisal (13 articles rated on the

Cochrane Risk of Bias Tool and Pedro Scale)

13 citations included in the final review

9 included articles hand searched. 4 additional

articles included for appraisal


Country and setting of the studies included. Details of geographic and

environmental settings are outlined below;

nine studies were based in America (Davidson et al., 2013; Fucile et al., 2008;

Hake-Brooks and Arvedson, 2008; Kirt et al., 2007; Law-Morstatt et al., 2003;

Standley, 2003; Standley et al., 2010; Simpson et al., 2002; White-Traut et al.,

2002), with eight of these American studies set in the Neonatal Intensive Care

Unit (NICU);

one study was based in Australia (Collins et al., 2004) and set in a tertiary referral

hospital;

one study (Puckett et al., 2008) was conducted in Canada and set in an NICU;

one study (Shaw et al., 1999) was based in England within hospital and home care

environments; and

one study (Yilmaz et al., 2014) was conducted in Turkey and set in an NICU.


Table 2.

Characteristics of Included Studies (ordered by intervention type)

Year Author Title Study

design

Population Number of

participants

(interventio

n, control)

Interventio

n

Control Key outcomes

2004 Collins

et al.

Effect of bottles, cups, and

dummies on breast feeding

in preterm infants: a

randomized controlled trial

RCT Preterm 89- 72, 73 Equipment No

dummy

Full breastfeeding

Any breastfeeding on

discharge home

1999 Shaw et

al.

Assisted feeding is more

reliable for infants with

clefts

RCT Cleft 52, 49 Equipment SC

(ridged

bottle)

Weight

Length

Head circumference

Full tube feeding

2008 Fucile et

al.

A Controlled-flow

Vacuum-free Bottle

System Enhances Preterm

Infants’ Nutritive Sucking

Skills

RCT Preterm 15,15 Equipment SC

(standard

bottle)

Overall transfer

Rate of milk transfer

Suction amplitude

Frequency of suction

Overall transfer

Sucking breast duration

2013 Yilmaz

et al.

Effect of Cup Feeding and

Bottle Feeding on

Breastfeeding in Late

Preterm Infants: A

Randomized Controlled

Study

RCT Preterm 254, 268 Equipment SC (bottle

feeding)

Weight gain

Feeding time

Hospital stay

Infant gestational age

at discharge

Any breastfeeding

Exclusive

breastfeeding

2002 Simpson,

Schanler,

and Lau

Early introduction of oral

feeding in preterm infants

RCT Preterm 28, 23 AROP SC

(initiation

of oral

Full tube feeding

Transition from tube to

total oral feeding


feeding >

48 hours

full tube

feeding)

First successful oral

feeding

4 successful oral

feedings

All oral feedings

Introduction of oral

feeding to first

successful oral feedings

First successful oral

feeding to all oral

feeding

Hospital discharge

2007 Kirk,

Alder

and King

Cue-based oral feeding

clinical pathway results in

earlier attainment of full

oral feeding in premature

infants

RCT Preterm 28, 23 AROP SC

(feeding

based on

physician

order)

PMA at full oral

feeding

PMA at full oral

feeding

Rate of weight gain

during oral feeding

phase

2003 Law-

Morstatt,

Judd,

Snyder,

Baier

and

Dhanired

dy

Pacing as a treatment

technique for transitional

sucking

RCT Preterm 18,18 AROP SC

(traditiona

l bottle

feed)

Chronological age at

NICU discharge date

PCA at NICU

discharge date

Bradycardias

Weekly weight gain

Discharge weight

2013 Davidso

n,

Hinton,

Ryan-

Wenge

Quality improvement

study of effectiveness of

Cue‐Based feeding in

infants with

Bronchopulmonary

RCT Bronchop

ulmonary

Dysplasia

55, 60 AROP SC

(traditiona

l feeding

pathway)

PMA at first oral

feeding (weeks)

Days from first to full

oral feeding

Overall weight gain (g)


and

Jadcherla

dysplasia in the neonatal

intensive care unit

Average weight

velocity (g.kg/day)

2008 Puckett,

Grover,

Holt and

Sankaran

Cue-Based Feeding for

Preterm Infants: A

Prospective Trial

RCT Preterm 39, 40 AROP Demand

feed

Cues per feed

Feedings per day

Bottle feeder intake

Length of stay

Weight gain

Exit weight

PCA at exit

Adverse events

Nasal prong with

oxygen at exit

2003 Standley The Effect of Music-

Reinforced Nonnutritive

Sucking On Feeding Rate

of Premature Infants

RCT Preterm 16, 16 Environme

ntal

AM feeding rate

PM feeding rate

2010 Standley

et al.

The Effect of Music

Reinforcement for Non-

Nutritive Sucking on

Nipple Feeding Of

Premature Infants

RCT Preterm 8-8,8 Environme

ntal

SC (no

PAL)

Gavage days

Days to discharge

Discharge weight

Weight gain

2002 White-

Traut et

al.

Effect of auditory, tactile,

visual, and vestibular

intervention on length of

stay, alertness, and feeding

progression in preterm

infants


ntal

SC Length of hospital stay

Feeding progression

Alert state

2008 Hake-

Brooks

and

Anderso

n

Kangaroo care and

breastfeeding of mother-

preterm infant dyads 0–18

months: A randomized,

controlled trial


ntal

SC (no

KC)

Mean IBS score

Time reached exclusive

breast feed


Note. AROP = Altering rate of presentation; SC = Standard care; PAL = Pacifier activated lullaby system; KC = Kangaroo care; PMA =

Postmenstrual age; PCA = Post conceptual age; IBS = Index of breastfeeding status; NICU = Neonatal intensive care unit.


Participants. Articles included the following populations:

eleven articles examined populations of Preterm infants (Collins et al., 2004;

Fucile et al., 2008; Hake-Brooks & Anderson, 2008; Kirk et al., 2007; Law-

Morstatt et al., 2003; Simpson et al., 2002; Puckett et al., 2008; Standley. 2003;

Standley et al., 2010; White-Traut et al., 2002; Yilmaz et al., 2013);

one study examined infants with Cleft Palate (Shaw et al., 1999); and

one study examined infants with Bronchopulmonary Dysplasia (Davidson et al.,

2013) (Figure 2).

Figure 2. Population breakdown.

The number of participants within each intervention group ranged between eight

(Shaw et al., 1999) to 268 infants (Yilmaz et al., 2015) (across all populations and

interventions). The age of participants varied between 23 weeks (gestational age) and one

year of age. Although parents were involved in administering some interventions, no

studies directly assessed effects of intervention on parental outcomes.

84%

8%

8%

Populations

Preterm

Cleft Palate

Bronchopulmonary

Dysplasia


Interventions. Indirect interventions were used in all articles. However, different

approaches to indirect management were taken. Of the reviewed studies,

four involved the use of equipment (Collins et al., 2004; Fucile et al., 2008; Shaw

et al., 1999; Yilmaz et al., 2014);

five altered the rate of presentation (Davidson et al., 2013; Kirt et al., 2007; Law-

Morstatt et al., 2003; Puckett et al., 2008; Simpson et al., 2002); and

four involved environmental changes (Hake-Brooks & Anderson, 2008; Standley.

2003; Standley et al., 2010; White-Traut et al., 2002) (see Figure 3).

Figure 3. Intervention breakdown.

Interventions were administered by Nurses, (Collins et al., 2004; Davidson et al.,

2013; Fucile et al., 2008; Hake-Brookes & Anderson, 2008; Kirk et al., 2007; Law-

Morstatt et al., 2003; Pucket et al., 2008; Shaw et al., 1999; White-Traut et al., 2002;

Yilmaz et al., 2015;), attending Physicians (Kirk et al., 2007; Simpson et al., 2002),

Neonatologists (Collins et al., 2004), Physical Therapists (Law-Morstatt et al., 2003)

Occupational Therapists (Kirk et al., 2007), Lactation Consultants (Hake-Brookes &

Anderson, 2008), Music Therapists (Standley et al., 2010), Midwives (Collins et al.,

2004) and parents (Pucket et al., 2008; Shaw et al., 1999; Yilmaz et al., 2015).

31%

38%

31%

Interventions

Equipment

Altering rate of

presentation


Four articles commenced intervention according to department protocols

regarding infant readiness cues (e.g., tolerance of full enteral feedings, tolerance of skin to

skin contact, ability to sustain non-nutritive suck, transition to alert state) (Davidson et al.,

2013; Kirk et al., 2007; Pucket et al., 2008; Yilmaz et al., 2015). Three articles

commenced intervention according to arbitrary time stipulations (e.g., at 34 weeks, 48

hours post full enteral feeding or 24 hours following referral to service) (Shaw et al.,

1999; Simpson et al., 2002; Standley et al., 2010). One article commenced treatment as

soon as possible post birth (Hake-Brookes & Anderson, 2008). One article commenced

trials when the participant’s mother was unable to breastfeed (Collins et al., 2004). Four

articles provided no details about commencement of intervention (Fucile et al., 2008;

Law-Morstatt et al., 2003; Standley, 2003; White-Traut et al., 2002).

Treatment intensity varied across articles and ranged between one (Fucile et al.,

2008) and eight sessions per day (Standley, 2003).

Equipment. In Collins and colleagues (2004) artificial teats (bottles and

dummies) were offered to infants of mothers who were unable to breastfeed. Fucile and

colleagues (2008) compared a controlled flow vacuum free bottle to a standard bottle.

Yilmaz and fellow researchers (2014) examined the effects of cup and bottle-feeding.

Shaw’s group (1999) compared the effectiveness of squeezable bottles to standard, ridged

feeding bottles.

Altering rate of presentation. Davidson and colleagues (2013) altered rate of

presentation of feeding by implementing a cue-based feeding strategy based on infant

driven readiness cues. Similarly, Kirt and colleagues (2007) implemented a cue-based

pathway based on feeding readiness and hunger signs. Additionally, Puckett and fellow

researchers (2008) implemented a cue-based model where infants transitioned between


gavage and bottle-feeding to feeding based on demand. Law-Morstatt and colleagues

(2003) applied a paced feeding protocol where feeders regulate the number of sucks per

burst and duration of burst by systematically removing the teat to impose breathing

pauses. Simpson’s group (2002) shortened transition time to oral feeding by introducing

early oral feeding 48 hours after achieving full tube feeding.

Environmental changes. Standley (2003) used music to reinforce nonnutritive

sucking and feeding rate. Similarly, Standley and colleagues (2010) used music to

reinforce nonnutritive sucking on nipple feeding infants. White-Traut’s group (2002)

implemented an auditory, tactile, visual and vestibular intervention. Hake-Brooks and

colleagues (2008) used kangaroo care to calm the infant by raising the infant’s

temperature via swaddling and facilitating skin to skin contact between mother and child

during breastfeeding.

Outcome Measures

Outcomes were measured at baseline and immediately post treatment across all

included articles. Some articles examined performance at different schedules post-

treatment. For example, at one (White-Traut et al., 2002; Yilmaz et al., 2014), two

(White-Traut et al., 2002; Yilmaz et al., 2014), three (White-Traut et al., 2002), six (Shaw

et al., 1999; Hake-Brooks & Anderson, 2008), 13 (Shaw et al., 1999), 26 (Shaw et al.,

1999) and 34 weeks post-treatment (Standley et al., 2010).

Several articles conducted additional outcome assessments at three (Hake-Brooks

& Anderson, 2008; Yilmaz et al., 2014), six (Hake-Brooks & Anderson, 2008; Yilmaz et

al., 2014;), eight (Standley et al., 2010), nine (Standley et al., 2010), 12 (Hake-Brooks &

Anderson, 2008; Shaw et al., 1999) and 18 months (Hake-Brooks & Anderson, 2008).

Articles did not provide any additional, post treatment follow up outcomes.


All articles included outcome measures, which could be dived into three

categories; anthropometric (comparative, morphological traits) (Ulijaszek & Kerr, 1999),

feeding and length of stay measures. Outcomes according to article are outlined in Table

3.

Table 3.

Outcome Measures for Included Articles (ordered according to outcome)

Outcome

category

Study Outcome

Feeding Fucile et al. (2008) Overall transfer

Rate of milk transfer

Suction amplitude

Frequency of suction

Overall transfer

Sucking breast duration

Yilmaz et al. (2014) Feeding time

Any breastfeeding

Exclusive breastfeeding

Standley et al. (2010) Gavage days

Davidson et al. (2013) Days from first to full oral feeding

Standley (2003) AM feeding rate

PM feeding rate

Puckett et al. (2008) Feeding

Feedings per day

Bottle feeder intake

Collins et al. (2004) Full breast feeding

Any breastfeeding at discharge home

White-Traut et al. (2002) Feeding progression

Alert state

Hake-Brooks and

Anderson (2008)

Feeding

Time reached exclusive breast feed

Simpson et al. (2002) Full tube feeding


Transition from tube to all oral feeding

Introduction from oral feeding to first

successful oral feed

Anthropometric Kirk et al. (2007) Rate of weight gain during oral feeding phase

PMA at full oral feeding

Yilmaz et al. (2014) Weight gain

Infant gestational age at discharge

Shaw et al. (1999) Weight

Length

Head circumference

Full tube feeding

Law-Morstatt et al. (2003) Chronological age at NICU discharge date

PCA at NICU discharge date

Bradycardias

Weekly weight gain

Discharge weight

Standley et al. (2010) Discharge weight

Weight gain

Davidson et al. (2013) PMA at first oral feeding

Overall weight gain

Average weight velocity

Puckett et al. (2008) Weight gain

Exit weight

PCA at exit

Adverse events

Nasal prong with oxygen at exit

Length of stay Yilmaz et al. (2014) Hospital stay

Law-Morstatt et al. (2003) Weeks in study

Standley et al. (2010) Days to discharge

Puckett et al. (2008) Length of stay

White-Traut et al. (2002) Length of stay

Simpson et al. (2002) Hospital discharge

Note. PMA = Postmenstrual age; PCA = Post conceptual age; IBS = Index of

breastfeeding status.


Quality appraisal

Articles were appraised for quality across a number of groups (all included articles

and individual intervention type). Final ratings for all intervention articles on both scales

can be seen in Table 4 and 5. Despite biases relating to the implementation of

interventions (around the allocation concealment and blinding of participants, therapists

implementing intervention), the Cochrane GRADE approach (Higgins et al., 2008)

suggests intervention articles were of high methodological quality with transparent

outcome reporting and specified eligibility criteria of participants.

Combined quality ratings for all included articles. On the CROBT high scoring

(low risk of bias) items included selective reporting bias (93%), complete outcome data

(77%) and other bias (77%). Low scoring (high risk of bias) items related to allocation

concealment (70%) and blinding of participants, personnel and outcome assessors (70%).

Combined quality ratings for the CROBT can be seen in Figure 5.

Figure 5. Combined ratings- CROBT


Table 4.

Risk of Bias Summary (PS): Agreed Rater Judgements for Each Risk of Bias Criterion for Each Included Study

Criterion

Study

Eli

gib

ilit

y c

rite

ria

wer

e sp

ecif

ied

Subje

cts

wer

e ra

ndom

ly a

lloca

ted t

o g

roups

(in

a c

ross

over

stu

dy, su

bje

cts

wer

e

random

ly a

lloca

ted a

n o

rder

in w

hic

h

trea

tmen

ts w

ere

rece

ived

)

All

oca

tion w

as c

once

aled

The

gro

ups

wer

e si

mil

ar a

t bas

elin

e

regar

din

g t

he

most

im

port

ant

pro

gnost

ic

indic

ators

Ther

e w

as b

lindin

g o

f al

l su

bje

cts

Ther

e w

as b

lindin

g o

f al

l th

erap

ists

who

adm

inis

tere

d t

he

ther

apy

Ther

e w

as b

lindin

g o

f al

l as

sess

ors

who

mea

sure

d a

t le

ast

one

key

outc

om

e

Mea

sure

s o

f at

lea

st o

ne

key

outc

om

e w

ere

obta

ined

fro

m m

ore

than

85%

of

the

subje

cts

init

iall

y a

lloca

ted t

o g

roups

All

su

bje

cts

for

whom

ou

tcom

e m

easu

res

wer

e av

aila

ble

rec

eived

the

trea

tmen

t or

contr

ol

condit

ion a

s al

loca

ted o

r, w

her

e th

is

was

not

the

case

, dat

a fo

r at

lea

st o

ne

key

outc

om

e w

as a

nal

yze

d b

y “

inte

nti

on t

o

trea

t”

The

resu

lts

of

bet

wee

n-g

roup s

tati

stic

al

com

par

isons

are

repo

rted

for

at l

east

one

key

outc

om

e

The

study

pro

vid

es b

oth

poin

t m

easu

res

and

mea

sure

s of

var

iabil

ity f

or

at l

east

one

key

outc

om

e

Collins et

al. (2004)

Yes Yes Yes No No No No Yes Yes Yes Yes

Shaw et al.

(1999)

Yes Yes Yes Yes No No No Yes Yes Yes Yes

Simpson et

al. (2002)

Yes Yes No Yes No No No Yes No Yes Yes

Standley

(2003)

Yes Yes No Yes Yes Yes No Yes Yes Yes Yes

White-

Traut et al.

Yes Yes No Yes Yes No Yes No No Yes No


(2002)

Kirk et al.

(2007)

Yes No No Yes No No No Yes No Yes Yes

Fucile et al.

(2008)


Law-

Morstatt et

al. (2003)


Davidson et

al. (2013)

No No No No No No No Yes No Yes Yes

Standley et

al. (2010)

Yes Yes No Yes Yes No No Yes No Yes Yes

Yilmaz et

al.

Yes Yes Yes Yes No No Yes Yes Yes Yes Yes

Puckett et

al. (2008)

Yes Yes No Yes No No No Yes Yes Yes Yes

Hake-

Brooks and

Anderson

(2008)

Yes

Yes

No No No No No Yes No Yes Yes

Note. Red = No; Green = Yes.


Table 5.

Risk of Bias Summary (CROBT): Agreed Rater Judgements for Each Risk of Bias Criterion for Each Included Study

Criterion

Article

Adeq

uat

e

sequen

ce

gen

erat

ion

All

oca

tion

conce

alm

ent

Bli

ndin

g o

f

par

tici

pan

ts,

per

sonnel

and o

utc

om

e

asse

ssors

Inco

mple

te

outc

om

e dat

a

addre

ssed

Fre

e of

sele

ctiv

e

outc

om

e

report

ing

Oth

er b

ias

Collins et al. (2004) Low Low High Low Low High

Shaw et al. (1999) Low Low High Low High Low

Simpson et al. (2002) High High High Unclear Low Low

Standley (2003) High High Low High Low Low

Kirk et al. (2007) High High High Low Low Low

Fucile et al. (2008) High High High Low Low Low

Law-Morstatt et al. (2003) High High High Low Low Low

Davidson et al. (2013) High High High Low Low High

Standley et al. (2010) High High Low Low Low Low

Yilmaz et al. 2014 Low Low Low Low Low Low

White-Traut et al. (2002) Unclear Unclear Low High Low Low

Puckett et al. (2008) Low High High Low Low High


Note. Red = No; Green = Yes; Yellow = Unclear.

Hake-Brooks and Anderson

(2008)

Low High High Low Low Low


On the PS, highest scoring (low risk of bias) items included reported results of

between-group statistical comparisons for at least one key outcome (100%), point

measures and measures of variability for at least one key outcome (92%) and

specification of eligibility criteria (92%). Low scoring (high risk of bias) items included

blinding of all therapists who administered the therapy (93%), blinding of all assessors

who measured at least one key outcome (84%) and concealment of treatment allocation

(76%). Combined quality ratings for the PS can be seen in Figure 6.

Figure 6. Combined ratings- PS

Quality appraisal based on intervention type

Equipment. On the CROBT, all articles relating to the use of equipment had a

low risk of other bias. 75% of articles had a high risk of bias relating to participant

allocation concealment. Combined quality ratings for use of equipment can be seen in

Figure 7.


Figure 7. Combined quality ratings for interventions involving equipment- CROBT.

On the PS, all articles examining the use of equipment reported results of

between-group statistical comparisons for at least one key outcome, specified eligibility

criteria, obtained measures of at least one key outcome from more than 85% of the

subjects initially allocated to groups and provided both point measures and measures of

variability for at least one key outcome. No articles blinded subjects or therapy assistants.

Combined quality ratings for use of equipment can be seen in Figure 8.

Figure 8. Combined quality ratings for interventions involving equipment- PS.


Rate of presentation. All CROBT appraisals for interventions that altered the rate

of presentation had a low risk of bias relating to blinding of participants, personnel and

outcome assessors, allocation concealment and were free of selective outcome reporting.

40% of articles had a high risk of other bias. Combined quality ratings for interventions

altering rate of presentation can be seen in Figure 9.

Figure 9. Combined quality ratings for interventions altering rate of presentation-

CROBT.

On the PS, all articles altering the rate of presentation blinded all subjects,

therapists who administered the therapy and assessors who measured at least one key

outcome. Additionally, all articles included measures of at least one key outcome from

more than 85% of the subjects initially allocated to groups, reported results of between-

group statistical comparisons for at least one key outcome and provided both point

measures and measures of variability for at least one key outcome. 100% of studies

articles failed to conceal allocation. Combined quality ratings for interventions altering

rate of presentation can be seen in Figure 10.


Figure 10. Combined quality ratings for interventions altering rate of presentation- PS

Environmental change. On the CROBT, all articles examining interventions

involving an environmental change had a low risk of other bias. 75% of articles had a

high risk of bias in relation to blinding of participants, personnel and outcome assessors.

Combined quality ratings for interventions involving an environmental change can be

seen in Figure 11.

Figure 11. Combined quality ratings for interventions involving an environmental

change- CRBT.


On the PS, all environmental interventions specified eligibility criteria, randomly

allocated subjects to groups and reported between-group statistical comparisons for at

least one key outcome. All articles failed to blind therapists administering therapy and

75% of studies did not conceal allocation. Combined quality ratings for interventions

involving an environmental change can be seen in Figure 12.

Figure 12. Combined quality ratings for interventions involving an environmental change

- PS.

Reported effects of intervention and data synthesis

Data synthesis was performed on nine articles (Davidson et al., 2013; Fucile et al.,

2008; Kirk et al., 2007; Law-Morstatt et al., 2003; Puckett et al., 2008; Shaw et al., 1999;

Simpson et al., 2002; Standley et al., 2010; Yilmaz et al., 2014). Four articles (Collins et

al., 2004; Hake-Brooks & Anderson, 2008; Standley, 2003; White-Traut et al., 2007) did

not provide descriptive measures and were therefore not included in data synthesis.

Equipment. Three out of four articles examining use of equipment reported

positive effects on feeding. Two studies (Collins et al., 2004; Yilmaz et al., 2014) found

infants randomized to cup feeding were more likely to be exclusively breastfed on


discharge, with Yilmaz and colleagues reporting increased rates of breastfeeding at three

and six months post discharge, when compared to bottle fed controls. In Fucile and

colleagues (2008), infants using a controlled vacuum free bottle demonstrated greater

overall milk transfer, rate of transfer and more mature sucking signs, however differences

in sucking amplitude were observed between intervention and standard care infants.

Yilmaz and colleagues reported no significant reduction in time spent feeding and

frequency of feeding problems. One study reported weak anthropometric effects; Shaw and

colleagues (1999) observed no significant change in crown-heel length. However, Shaw’s

group saw the use of a squeezable bottle lead to statistically significant differences in

weight gain and head circumference. The use of equipment was observed to have positive

effects on length of stay; Collins and colleagues found infants using equipment remained in

hospital for shorter periods of time, whilst Yilmaz and colleagues observed a significant

difference between groups for length of hospital stay.

Data synthesis revealed a positive effect of equipment on eight feeding outcomes;

sucking breast duration at six to eight feedings per day (n = 30, g = 0.27, 95% CI: -0.42,

0.97) and sucking duration were observed in Fucile and colleagues (2008). Yilmaz’ team

(2014) reported positive effects for any breastfeeding at three months (n = 522, g = 0.02,

95% CI = -0.14, 0.19) and feeding time (n = 522, g = 0.06, 95% CI = -0.11,0.23).

Additionally, the use of equipment had a statistically significant effect on any

breastfeeding at six months (n = 522, g = 0.28, 95% CI: 0.10, 0.45), any breastfeeding at

discharge (n = 255, g = 0.08, 95% CI: -0.08, 0.25) and exclusive breastfeeding at

discharge (n = 255, g = 1.01, 95% CI: 0.83, 1.19) in Yilmaz’ group. One positive effect

was observed for anthropometric measures in Shaw and colleagues (length at week 6 [n =

100, g = 0.00, 95% CI: -0.39, 0.19]). One positive effect was observed for length of stay

measures in Yilmaz and colleagues (hospital stay duration [n = 254, g = 0.09, 95% CI -


0.26, 0.08]). See Appendix G for effect sizes and corresponding forest plots for

interventions involving modified equipment use.

Altering rate of presentation. Four studies reported positive effects on feeding

when interventions altered the rate of presentation, with three studies reporting shorter

time to oral feeding; Simpson and colleagues (2002) found infants who were introduced

to early oral feeding attained total oral feeding significantly earlier than controls who

were tube fed for longer than 48 hours, (however, no difference was observed in overall

transfer and rate of milk transfer). Kirk and colleagues (2007) found infants following a

cue based pathway reached full oral feeding earlier than standard care controls, whilst

Davidson’ team (2013) saw infants in the cue based feeding group reach full oral feeding

in significantly less time. Additionally, Law-Morstatt’s group (2003) observed more

efficient sucking patterns at discharge. Two studies reported positive effects on

anthropometric measures; Law-Morstatt and colleagues and Puckett and colleagues

(2008) saw increases in clinical stability with decreased adverse events. Weight gain of

study infants varied; Davidson’s team saw greater average weight velocity in the cue

based group, however, two studies (Law-Morstatt et al.,; Puckett et al.,) did not report

statistically significant weight gain. Length of stay was reported to be significantly shorter

in one study (Puckett et al.) however these effects were not replicated (Law-Morstatt et

al.).

Data synthesis revealed a positive but non-significant effect of altering rate of

presentation on three anthropometric outcomes: average weight velocity (n = 155, g =

0.18, 95% CI: -0.17, 0.55); PMA at first oral feed (n = 115, g = 0.08%, 95% CI: -0.27,

0.45 (both Davidson et al., 2013); and rate of weight gain (n = 51, g = 0.41, 95% CI: -

0.13, 0.96) (Kirk et al., 2007). Altering rate of presentation had a statistically significant

effect (n = 51, g = 0.94, 95% CI: 0.19, 1.69) on one feeding outcome (introduction of oral


feeding to first full oral feed) (Simpson et al., 2002). Additionally, positive effects (n =

29, g = 0.24, 95% CI: -0.46, 0.95) were observed for a second feeding outcome (first

successful oral feed) (Simpson et al.). Four significant effects were observed for length of

stay measures: length of stay after entry adjusted for gestation age (n= 39, g = 0.58, CI: [-

1.03,-0.14] (Pucket et al., 2008); non adjusted length of stay n= 39, g = 0.58, CI: [-1.03,-

0.14] (Pucket et al.); hospital discharge (days n= 13, g= 0.56, CI: [-1.29, 0.15]; and weeks

n = 13, g = 0.55, [-1.27, 0.17]) (Simpson et al., 2002). See Appendix H for effect sizes

and corresponding forest plots for interventions altering rate of presentation.

Environmental changes. All studies involving environmental change reported

positive effects relating to feeding: Standley and colleagues (2010) and Standley (2003)

found music reinforced non-nutritive sucking to significantly shorten time required for

gavage feeding, with increased overall feeding rates. Hake-Brooks and Anderson (2008)

found Kangaroo Care infants to breastfeed significantly longer, than standard care,

control infants, with Kangaroo Care infants more likely to be exclusively breast fed at

discharge. White-Traut and colleagues (2002) reported increased alertness leading to a

more rapid transition to breast-feeding following an auditory, tactile, visual, and

vestibular intervention. Positive effects on length of stay were also observed in Standley

and colleagues and White-Traut and colleagues who reported decreased length of

hospitalisation.

Data synthesis revealed a positive effect of interventions involving an

environmental change on two feeding outcomes reported in Standley and colleagues

(2010); number of gavage days at weeks 34 (n = 16, g = 0.93, 95% CI: -0.04, 1.91) and

36 (n = 15, g = 0.05, 95% CI: -0.90, 1.00). Standley’s group also reported positive effects

for two anthropometric outcomes: weight gain at week 36 weeks (n = 15, g = 0.68, 95%

CI: -1.42, 0.58) and discharge weight at week 34 (n = 15, g = 0.32, 95% CI: -0.63, 1.28).


Significant effects were observed for length of stay measures reported in Stadley and

colleagues (2010; days to discharge at week 32 (n= 8, g = 0.27, CI: [-1.2, 0.66]), days to

discharge at week 34 (n = 8, g = 0.11, CI: [-1.07, 0.84]) and days to discharge at week (36 n =

8, g = 0.43, CI: [-1.43, 0.57]). See Appendix I for effect sizes for interventions and

corresponding forest plots involving an environmental change.

Discussion

A systematic review was conducted in order to establish the quality of the

evidence for indirect paediatric dysphagia interventions, and to draw comparisons

between the effects of various indirect approaches. In turn, 13 randomised and quasi-

randomised control articles were examined to answer the following research questions:

(i) What is the current quality of evidence for indirect management of paediatric

dysphagia?

(ii) What is the treatment effect of indirect approaches?

Quality of evidence

Quality of all included evidence. The literature search demonstrated that there

are a large number of studies advocating the efficacy of indirect interventions for children

with paediatric dysphagia. However, despite the quantity, the availability of high quality

of studies is sparse. This was demonstrated throughout the search process, where a large

proportion of retrieved results were excluded on the basis of not being randomised

intervention trials. Nonetheless, for the 13 RCTs supplied in this review, articles were

deemed to be of high quality according to the Cochrane GRADE approach (Higgins et al.,

2002).

For articles included in this review, bias predominately reflected limitations

related to the implementation of intervention, which resulted in attrition bias (Searle,

1999). Ratings on both the CROBT and PS were consistent in revealing a high risk of bias


relating to the allocation concealment and blinding of participants, therapists

implementing intervention and outcome assessors. According to Karanicolas, Farrokhyar,

and Bhandari, (2010), failure to conceal treatment allocation by blinding can be

problematic. In their account, blinding is described as a means of minimizing the risk of

differential assessment of outcomes, as it prevents biased treatment effects, where the

expectation of a response is provided or scored, rather than the response itself

(Karanicolas, Farrokhyar, & Bhandari, 2010).

Unfortunately, the nature of the studies included in this review, as well as speech

pathology literature more generally, mean interventions are reliant on a behavioural

modification which results in a degree of inherent bias (Karanicolas, Bhandari, Walter

(2009). For example, it may not always be possible to blind treatment conditions from

assessors (e.g., it is difficult to blind an administering therapist from viewing bottle type

as they need to see what they are doing). Other times, it may not be necessary to blind

participants (e.g., when working with infants, their young age may mean it is not

necessary to conceal treatment allocation). These factors make it increasingly difficult to

blind trials within speech pathology, when compared to other areas of healthcare, such as

medicine, which can achieve blinding with placebos (Karanicolas, Farrokhyar, &

Bhandari, 2010).

Even so, Karanicolas and colleagues (2010) argue creative or novel techniques

can make blinding achievable. For example, one article (White-Traut et al., 2002)

included in the current review was able to achieve a low of bias pertaining to blinding by

assigning separate individuals for intervention and outcome assessment. In this study the

assessor was positioned behind a screen and required to wear soundproof headphones

before entering the room to assess the outcome (participant behavioral state). This


blinding attempt was commendable as it successfully concealed the group allocation

without impairing the ability to accurately assess outcomes (Karanicolas et al., 2009).

Karanicolas and colleagues (2010) suggest that if blinding is not possible, induced

bias can be counterbalanced by accurate reporting. Across the CROBT and PS, included

articles were not selective in their reporting; all articles included results of between-group

statistical comparisons, with most studies providing measures of variability and

addressing incomplete outcome data. The inclusion of outcomes prevented within-study

publication bias, where systematic differences between reported and unreported findings

exist, and statistically significant outcomes are reported in favor of non-significant effects

(Higgins, 2011).

Finally, most articles specified eligibility criteria. Whilst providing the

characteristics of study participants enables replication for future studies, it also allows

results to be more easily generalized back to a broader population of individuals with the

same features (Morgan et al., 2011).

Articles examining equipment use. According to the GRADE approach (Higgins

et al., 2008), interventions involving adapted equipment were of moderate quality.

Moderate ratings reflected a number of high-risk judgements relating to the absence

blinding for participants, therapists and assessors. As discussed previously, blinding an

equipment change is challenging and it is realistic assume some degree of inherent bias

(Karanicolas et al., 2009). However, a large proportion of the interventions modifying

equipment also failed to address incomplete outcome data, which resulted selective

reporting and the possibility of publication bias (Higgins et al., 2008).

Quality of articles involving an environmental change. According to the

GRADE approach, articles involving an environmental change were deemed to be of high

quality (Higgins et al., 2008). Articles consistently reported participant eligibility criteria


on the CROBT and PS. Both scales revealed a high risk of bias relating to the blinding of

participants, assistants and outcome assessors. Similar to articles involving an equipment

change, blinding a temperature, noise or lighting change is improbable due to the reasons

previously discussed.

Quality of articles altering rate of presentation. Ratings for interventions

altering schedule of intake indicate low or no risk of bias on most criterions and were

deemed to be of high quality according to the GRADE approach. Unlike the

aforementioned interventions, authors consistently blinded participants, therapists and

assessors. However, study design limitations resulted in a moderate risk of other bias. For

example, Kirk and colleagues (2007) examined a retrospective group of infants, rather

than randomised controls. Whilst study infants were randomised, the use of historic

controls meant control group infants were not matched for gestational age, birth or

weight, and this may have led to bias as study and control groups may not have been at

similar baselines. Additionally, feeding pathway compliance was not measured in this

study and there may have been subsequent variations in treatment intensity may have

impacted treatment efficacy (Searle, 1999).

Effects of interventions

Equipment. Reported outcomes of articles examining equipment use, as well as

the effect size calculations conducted in this review indicate the use of modified

equipment has a positive effect on feeding. Whilst most of the included articles reported

positive outcomes in relation to feeding and anthropometric measures, data synthesis

revealed positive effects on feeding and length of stay measures. Notably, of the feeding

outcomes, cup feeding resulted in both positive and some statistically significant

increases in breastfeeding prior to and post discharge (Yilmaz et al., 2014). The idea that

modified equipment leads to improved feeding is consistent with current evidence.


Yilmaz and colleagues argue the positive effects of cup feeding relate to the idea that

modified equipment can provide an alternative to enteral nutrition, and instead promote

positive parent-infant interactions through the development of eye contact and body

language. Additionally, unlike enteral nutrition, cup feeding is argued to encourage self-

regulation as the infant is provided with the opportunity to learn to how to increase or

restrict their intake.

Reported outcomes and effect size calculations suggest modified equipment has a

small effect on hospital stay duration (Yilmaz et al., 2014). It is likely that these effects

can be supported by the explanation above, and it can be further inferred that an

alternative to enteral nutrition reduces reliance on hospital bound equipment (e.g.

nasogastric tube), whilst promoting self regulation and feeding independence.

Although data synthesis revealed a positive effect for one anthropometric measure

(length at week 6) following the use of a squeezable bottle in Shaw and colleagues

(1999), it is likely this effect was counterbalanced by no change in two effects (weight

and crown-heel length) reported in the same study.

Altering rate of presentation. All articles altering rate of presentation reported

positive outcomes across length of stay, anthropometric and feeding outcomes. Effect

analysis performed in this review suggest that altering the rate of presentation intake does

lead to improved feeding, anthropometric and length of stay outcomes.

In terms of feeding outcomes, effect calculations computed in this review support

the early introduction of oral feeding, as this significantly shortened the time to the first

full oral feed (Simpson et al., 2002). Additionally, early oral feeding was supported by a

second positive effect (first successful oral feed). Pridham, Brown, Sondel, Green, Wedel,

and Lai (1998) argue positive feeding outcomes resulting from cue-based methods reflect


an individualised approach to feeding, where feeding decisions are based on the infant’s

unique physical and developmental markers.

Additional research suggests these effects offer support to the idea that preterm

infants who appear clinically ready, and are given the opportunity to feed orally, may

improve the development of their suck-swallow-breathe coordination with early practice

(Simpson et al., 2002). This notion is supported by a range of impairment based

intervention literature, which advocates the use of oral-motor exercises and exploration to

improve paediatric dysphagia. On the contrary, some evidence suggests that infants who

are introduced to oral feeding too early may learn to feed with immature and disordered

sucking patterns (Simpson et al.).

Significant effects were observed for three length of stay measures; length of stay

after entry adjusted for gestation age (Pucket et al., 2008); non adjusted length of stay

(Pucket et al.); and hospital discharge (days and weeks) (Simpson et al., 2002). Overall, it

appears altering rate of presentation results in reduced time in hospital.

According to effect analysis, altering the rate of presentation revealed a generated

a positive trend towards improved anthropometric outcomes (average weight velocity,

PMA at first oral feed and rate of weight gain), however, these effects were non-

significant.

Environmental. Articles involving an environmental change reported positive

effects for feeding and length of stay measures.

Data synthesis revealed environmental changes resulted in two improved feeding

outcomes (number of gavage days at weeks 34 and 36 [Standley et al., 2010]), however,

these outcomes were deemed to be non-significant. Similarly, this study reported non-

significant, positive effects for two anthropometric outcomes (weight gain at week 36

weeks and discharge weight at week 34). Environmental interventions resulted in


significant effects on length of stay and suggest environmental changes result in reduced

duration of hospital stay.

Potential bias in the review process

Whilst this review was conducted in accordance with the Cochrane guidelines for

systematic reviews (Higgins et al., 2008) and steps were taken to strengthen reliability

and validity, there are a number of methodological limitations, which are outlined below;

The first relates to time; the time to search and review articles was limited to three

months. This may have impacted results as older data released outside the time, or

newly published data was not considered.

Effect size calculations may be skewed in their ability to validate the effects of

intervention (Borstein et al. 2009), as analysis was based on the reported

measurements of only nine studies. Due to time restrictions, no further

calculations or attempts to contact authors for missing data were made for the four

studies which failed to provide the required descriptive measures.

Whilst some articles measured outcomes at similar intervals, articles varied in

treatment intensity. Due to the principles of experience dependent neuroplasticity

(Kleim, 2008), positive effect outcomes may reflect the use of high intensity

intervention schedules, rather treatment effects alone.

Finally, the author acknowledges that articles deemed to be of high quality

according to GRADE quality ratings may be influenced by the inclusion criteria

which stipulated that only RCTs would be included for review. However, this is

beyond the authors control as the implementation of a stringent inclusion criterion

reflects the limitations of the CROBT and PS, which can only rate RCTs (Higgins

et al. 2009; Physiotherapy Evidence Database, 1999).

Implications for research


The review process demonstrates a lack of high quality evidence exists. This is

demonstrated by the search, which aimed to capture and appraise a broad range of high

quality, indirect intervention evidence across a range of paediatric conditions. As the

development of effective dysphagia management has been recognised to be paramount in

reducing related health care costs (Siktberg & Bantz, 1999), additional research is

required. There are a number of further areas, which should be considered in order for

future studies to advance the current evidence base. These are outlined below.

Due to a lack of RCTs, only three intervention approaches could be summarised.

Additional between groups RCTs should be conducted in the area of diet

modifications, use of prosthesis, alternative avenues of intake, postural

modifications and behavioural approaches.

As no studies included in this review involved measures relating to parental

outcomes and study infants are reliant on their caregivers for intervention, parental

outcomes (e.g., opinions of intervention change, stress, enjoyment of their child)

should be included within treatment data. Future studies should consider broader

outcome measures, which relate to quality of life changes for participating

families.

To determine if change has been maintained post intervention, future RCTs should

provide information regarding long term follow up of feeding and swallowing.

The majority of studies in the present review were conducted in NICU settings

with limited transferability to real world settings. To determine the

appropriateness of interventions, ongoing studies should involve a broader range

of settings (e.g., home and school).

Future studies should include wider range of participant populations. 13 of the 15

studies included in this review were based on populations of preterm infants.


Although 40% of infants who experience oral feeding difficulties are born

prematurely (Pridham et al., 1998), and it is likely that current research reflects

this epidemiological pattern, examining a diverse range of populations would

broaden the depth of evidence and increase the representativeness of results for

full term infants with dysphagia.

To avoid placebo effects and high risk of bias assessments, RCTs should take

steps to ensure participants, administering assistants and outcome assessors

involved in trials are appropriately blinded to treatment conditions.

As meta-analysis could not be completed in this review, future high quality RCTS

should be used in meta-analysis. As meta-analysis is considered the highest level

of evidence (Sacket et al. 1996), meta-analysis would provide evidence-based way

of making direct comparisons between various indirect intervention types in order

to determine the most effective treatment option (Borstein et al. 2009).

Interestingly, Speech Pathologists were not involved in the development or

implementation of any of the reviewed interventions. As swallowing is a range of

Speech Pathology practice, and ASHA (2015) regards Speech Pathologists as key

members of swallowing intervention teams, future studies should input from

Speech Pathologists in order to share information regarding intervention design

and implementation.

Implications for practice

According to effect calculations, it appears that interventions involving the use of

environmental changes, modified equipment and altered rate of presentation lead to

improved feeding, subsequent advances in anthropometric outcomes and reduced time

spent in hospital. Although the reviewed intervention evidence did not directly include

speech pathology involvement, environmental changes, equipment modifications and


altering rate of presentation are well reported as management approaches in speech

pathology literature (ASHA, 2005; Arvedson, 2008; Arvedson & Brodsky, 1993; Cichero

& Murdoch, 2006; Kovar, 1997; Siktberg & Bantz, 1999). Additionally, as these

interventions contain a behavioural component, they can be readily applied to speech

pathology practice. As such, use of these interventions should be continued to advance the

outcomes of children with dysphagia. Improving these measures will likely lead to

benefits in the activity and participation of children with feeding and swallowing

disorders (WHO, 2001), as research suggests improvements in swallow function can

positively influence development (Sullivan et al., 2000), socialisation (Morgan et al.,

2004) and psychological function (Anand & Scalzo, 2000).

The current review highlights the continued need for multidisciplinary

management between many different health care professionals. Interventions were

implemented by seven different healthcare professions, with each article involving a

number of professions to achieve positive swallowing outcomes. As dysphagia is a

complex, multifaceted disorder, multidisciplinary management is required to achieve

holistic, person centred care (Wilken, 2012).

Conclusion

Whilst the review process demonstrates that more high quality research is needed,

the available RCTs are of high methodological quality, and the current review contributes

to the current evidence by synthesising and appraising indirect intervention evidence for

paediatric dysphagia. Additionally, this research supports previous research by suggesting

the use of modified equipment, environmental changes and altering rates of presentation

have positive effects on feeding, anthropometric and length of stay outcomes. Future

studies are needed to further validate the effects of intervention.


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Appendix A

CROBT (Higgins et al. 2008)

Domain Description Review authors’

judgment

Sequence generation

Describe the method used to generate the

allocation sequence in sufficient detail to

allow an assessment of whether it should

produce comparable groups.

Was the allocation

sequence

adequately

generated?

Allocation concealment

Describe the method used to conceal the

allocation sequence in sufficient detail to

determine whether intervention allocations

could have been foreseen in advance of, or

during, enrolment.

Was allocation

adequately

concealed?

Blinding of

participants, personnel

and outcome assessors

Assessments should be

made for each main

outcome (or class of

outcomes)

Describe all measures used, if any, to blind

study participants and personnel from

knowledge of which intervention a participant

received. Provide any information relating to

whether the intended blinding was effective.

Was knowledge of

the allocated

intervention

adequately

prevented during

the study?

Incomplete outcome

data

Assessments should be

made for each main

outcome (or class of

outcomes)

Describe the completeness of outcome data

for each main outcome, including attrition and

exclusions from the analysis. State whether

attrition and exclusions were reported, the

numbers in each intervention group

(compared with total randomized

participants), reasons for attrition/exclusions

where reported, and any re-inclusions in

analyses performed by the review authors.

Were incomplete

outcome data

adequately

addressed?

Selective outcome

reporting

State how the possibility of selective outcome

reporting was examined by the review

authors, and what was found.

Are reports of the

study free of

suggestion of

selective outcome

reporting?

Other sources of bias

State any important concerns about bias not

addressed in the other domains in the tool. If

particular questions/entries were pre-specified

in the review’s protocol, responses should be

provided for each question/entry.

Was the study

apparently free of

other problems

that could put it at

a high risk of bias?


Appendix B

PS (Physiotherapy Evidence Database, 1999)


Appendix C

Outcome measures for the inclusion of intervention articles (adapted from the WHO ICF

[2001]

Body structure

and function

Activity Participation Environmental

factors

(personal and

contextual)

Outco

me

measur

es

Aspiration

Pain

Failure to thrive

Malnutrition

Dehydration

Death

Growth

Physiologic function

(i.e. tongue mobility

and strength, jaw

mobility and

strength, coordination

of suck-swallow-

respiration, pooling

of food or fluid,

hyolaryngeal

excursion).

Swallow initiation

Oral feeding

(breast or

bottle)

Consistency of

diet

Broader diet

Independent

feeding

Tube feeding

Mealtime behavior

Quality of life

Mealtime

participation

Inclusion/

socialization

School/ vocational

attendance

Carer burden

Familial stress

Client opinion


Appendix D

Preliminary data extraction form

Criteria for inclusion

Article

Birth-18

Indirect

intervention

Group

treatment

Outcomes

English

language


Appendix E

Data extraction form- CROBT (Higgins et al. 2008)

Article

title:

Adequate

sequence

generatio

n

Allocation

concealmen

t

Blinding of

participant

s,

personnel

and

outcome

assessors

Incomplete

outcome

data

addressed

Free of

selective

outcome

reportin

g

Other

bias

Rating

Notes


Appendix F

Data extraction form- PS (Physiotherapy Evidence Database, 1999)

Criteria Where/ rating

Eligibility criteria were specified

Subjects were randomly allocated to

groups (in a crossover study, subjects

were randomly allocated an order in

which treatments were received)

Allocation was concealed

The groups were similar at baseline

regarding the most important

prognostic indicators

There was blinding of all subjects

There was blinding of all therapists who

administered the therapy

There was blinding of all assessors who

measured at least one key outcome

Measures of at least one key outcome

were obtained from more than 85% of

the subjects initially allocated to groups

All subjects for whom outcome

measures were available received the

treatment or control condition as

allocated or, where this was not the

case, data for at least one key outcome

was analyzed by “intention to treat”

The results of between-group statistical

comparisons are reported for at least

one key outcome

The study provides both point measures

and measures of variability for at least

one key outcome


Appendix G

Data synthesis for articles using modified equipment

Intervention Control

N Mean (SD) N Mean(SD) Effect

size CI95%

Fucile et al. (2008) rate of milk transfer at 1-2

feedings/day 15 14.1(3.5) 15 17.7(4.7) -0.84 [-1.57, -0.11]

Fucile et al. (2008) rate of milk transfer at 6-8

feedings/day 15 12.3(4.7) 15 18.9(3.4) -1.56 [-2.36, -0.76]

Fucile et al. (2008) sucking breast duration at

1-2 feedings/day 15 12.8(7.6) 15 16.2(16.2) -0.26 [-0.96, 0.43]

Fucile et al. (2008) sucking breast duration at

6-8 feedings/day 15 16.1(11.3) 15 13.4(7.6) *0.27 [-0.42, 0.97]

Fucile et al. (2008) suction amplitude at 1-2

feedings/day 15 -35.8(21.2) 15 -26.2(19.8) -0.45 [-1.16, 0.25]

Fucile et al. (2008) suction amplitude at 6-8

feedings/day 15 -52.0(47.3) 15 -35.7(25.7) -0.41 [-1.12, 0.28]

Shaw et al. (1999) head circumference at week

6 52 38.1(1.5) 48 38.5(1.5) -0.26 [-0.65, 0.12]


13 51 40.4(1.3) 49 41(1.3) -0.43 [-0.83, -0.04]


26 50 43.5(1.2) 49 44(1.3) -0.38 [-0.78, 0.11]


52 50 46.1(1.4) 49 47.1(1.4) -0.68 [-1.08, 0.02]

Shaw et al. (1999) length at week 6 52 55.3(2.0) 47 55.3(2.2) *0.00 [-0.39, 0.19]

Shaw et al. (1999) length at week 13 51 60.2(2.2) 48 60.3(1.9) -0.04 [-0.43, 0.45]




Shaw et al. (1999) weight at week 6 52 4.3(0.5) 49 4.4(0.5) -0.10 [-0.49, 0.83]



Yilmaz et al. (2014) any breastfeeding at 3m 254 223.0(88.0) 268 221.0(82.0) *0.02 [-0.14, 0.19]

Yilmaz et al. (2014) any breastfeeding at 6m 254 176.0(69.0) 268 158.0(59.0) *0.28 [0.10, 0.45]

Yilmaz et al. (2014) any breastfeeding at

discharge 254 252.0(99.0) 268 244.0(91.0) *0.08 [-0.08, 0.25]

Yilmaz et al. (2014) exclusive breastfeeding at

3m 254 196.0(77.0) 268 126(47) *1.10 [0.91, 1.28]


6m 254 146.0(57.0) 268 113(42) *0.66 [0.48, 0.83]


discharge 254 184.0(72.0) 268 123(46) *1.01 [0.83, 1.19]

Yilmaz et al. (2014) feeding time 254 13.7(1.7) 268 13.6(1.6) *0.06 [-0.11,0.23]

Yilmaz et al. (2014) hospital stay 254 25.7(2.2) 268 25.9(2.2) *0.09 [-0.26, 0.08]

Yilmaz et al. (2014) infant gestational age at

discharge 254 36.4(2.6) 268 36.5(2.5) -0.03 [-0.21, 0.13]

Yilmaz et al. (2014) weight gain in the first 7

days of study 254 16.7(1.5) 268 16.8(1.5) -0.06 [-0.23, 1.00]

Note. * = Positive effect of treatment (where 0.0-0.3 has a small effect, 0.3-0.5 has a moderate effect and 0.5-1 has a large effect). To demonstrate

positive effects of reduced length of stay, outcomes relating to length of stay measures have been inverted from negative to positive.


Figure 14. Forest plot demonstrating the effects of interventions using modified

equipment.

-3-2

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11

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day

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fee

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wk

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et

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Appendix H

Data synthesis table for articles altering rate of presentation


N Mean (SD) N Mean(SD) Effect size CI95%

Davidson et al. (2013) average weight velocity 55 14.0(11.0) 60 12.0(10.0) *0.18 [-0.17, 0.55]

Davidson et al. (2013) days from first to full oral feeding 55 9.0 (6.0) 60 19.0 (13.0) -0.96 [-1.35, -0.58]

Davidson et al. (2013) overall weight gain 55 350.0 (195.0) 60 461.0(316.0) -0.41 [-0.78, -0.00]

Davidson et al. (2013) PMA at first oral feeding 55 35.2 (1.63) 60 35.0(2.7) *0.08 [-0.27, 0.45]

Kirk et al. (2007) PMA at full oral feeding 28 252.0 (10.0) 23 258.0(11.0) -0.56 [-1.11, -0.01]

Kirk et al. (2007) rate of weight gain 28 14.5 (11.4) 23 9.4(13.0) *0.41 [-0.13, 0.96]

Law-Morstatt et al. (2003) bradycardias during feedings 18 15.7 (23.8) 18 34.4(33.0) -0.65 [-0.13, 0.96]

Law-Morstatt et al. (2003) chronological age at NICU discharge 18 5.0(3.0) 18 7.0(3.0) -0.65 [-0.22, 0.47]

Law-Morstatt et al. (2003) discharge weight 18 2196.0(342.0) 18 2360.0(418.0) -0.41 [-1.06, 0.22]

Law-Morstatt et al. (2003) mean bradycardias per week 18 6.12(8.51) 18 13.55(11.87) -0.70 [-1.36, -0.04]

Law-Morstatt et al. (2003) PCA at discharge date 18 36.0(2.0) 18 37.0(2.0) -0.48 [-1.13, 0.15]

Law-Morstatt et al. (2003) weekly weight gain 18 206(73.8) 18 251.0(108.0) -0.47 [1.12, 0.71]

Law-Morstatt et al. (2003) weeks in study 18 2.2(0.9) 18 2.6(1.1) -0.38 [-1.02, 0.26]

Pucket et al. (2008) adverse events 39 3.5(3.3) 40 12.8(14.4) -0.87 [-1.33, -0.41]

Pucket et al. (2008) bottle feeder intake 39 154.4(2.0) 40 155.8(20.1) -0.09 [-0.53, 0.34]


Pucket et al. (2008) exit weight 39 2304.0(234.0) 40 2379.0(227.0) -0.32 [-0.76, 0.11]

Pucket et al. (2008) LOS after entry adjusted for gestation age 39 10.0(3.4) 40 14.5(4.3) *1.14 [-1.61, -0.67]

Pucket et al. (2008) nonadjusted LOS 39 10.0(6.3) 40 14.5(8.6) *0.58 [-1.03,-0.14]

Pucket et al. (2008) PCA at exit weight gain 39 35.8(1.1) 40 36.5(1.5) -0.52 [0.97, -0.08]

Pucket et al. (2008) weight gain 39 12.6(4.1) 40 12.7(3.5) -0.02 [-0.46, 0.41]

Simpson et al. (2002) 4 successful oral feedings: PMA 13 34.1(1.7) 16 35.3(1.4) -0.75 [-1.49, -0.01]

Simpson et al. (2002) 4 successful oral feedings: PNA 13 43.6(13.7) 16 54.4(12.6) -0.80 [-1.54, -0.06]

Simpson et al. (2002) all oral feedings: PMA 13 43.5(1.6) 16 36.0(1.5) -0.94 [-1.69, -0.19]

Simpson et al. (2002) all oral feedings: PNA 13 46.4(13.9) 16 58.7(14.5) -0.83 [-1.58, -0.09]

Simpson et al. (2002) first successful total oral feed 13 13.8(8.8) 16 11.9(6.4) *0.24 [-0.46, 0.95]

Simpson et al. (2002) first successful oral feeding: PMA 13 34.4(1.) 16 34.3(0.9) -1.95 [-2.82, -1.08]

Simpson et al. (2002) first successful oral feeding: PNA 13 32.1(9.9) 16 46.9(10.9) -1.37 [-2.16, -0.57]

Simpson et al. (2002) hospital discharge (d) 13 57.0(17.7) 16 67.0(16.6) *0.56 [-1.29, 0.15]

Simpson et al. (2002) hospital discharge (w) 13 36.0(2.1) 16 37.1(1.8) *0.55 [-1.27, 0.17]

Simpson et al. (2002) introduction of oral feeding to 1st oral feed 13 9.3(7.7) 16 3.7(3.5) *0.94 [0.19, 1.69]

Simpson et al. (2002) introduction to oral feeding 13 31.1(1.3) 16 33.7(14.0) -2.15 [-3.05, -1.25]

Simpson et al. (2002) transition from tube to all oral feeding 13 26.8(12.3) 16 38.4(14.0) -0.84 [-1.59, -0.10]

Note. * = Positive effect of treatment (where 0.0-0.3 has a small effect, 0.3-0.5 has a moderate effect and 0.5-1 has a large effect); PMA =

Postmenstrual age; PCA = Post conceptual age; LOS = Length of stay; PNA = Post natal age. To demonstrate positive effects of reduced length

of stay, outcomes relating to length of stay measures have been inverted from negative to positive.


Figure 15. Forest plot demonstrating the effects of interventions altering rate of

presentation.

-4-3

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Appendix I

Data synthesis for articles involving an environmental change


N M (SD) N M (SD)

Effect

Size 95% CI

Standley et al. (2010) discharge weight at week 32 8 2.2(0.5) 8 2.4(0.5) -0.28 [-1.21, 0.64]

Standley et al. (2010) discharge weight at week 34 8 2.2(0.36 7 2.1(0.1) *0.32 [-0.63, 1.28]

Standley et al. (2010) discharge weight at week 36 8 2.2(0.28) 6 2.6(0.6) -0.78 [-1.83, 0.23]

Standley et al. (2010) gavage days at week 32 8 46.7(17.3) 8 48.5(15.8) -0.09 [-1.02, 0.82]

Standley et al. (2010) gavage days at week 34 8 46.7(17.3) 8 33.2(8.5) *0.93 [-0.04, 1.91]

Standley et al. (2010) gavage days at week 36 8 68.8(25.3) 7 67.7(13.3) *0.05 [-0.90, 1.00]

Standley et al. (2010) days to discharge at week 32 8 5.1(2.36) 8 6.0(3.5) *0.27 [-1.2, 0.66]



Standley et al. (2010) weight gain at week 32 8 1.0(0.5) 8 1.1(0.5) -0.28 [-1.21, 0.65]

Standley et al. (2010) weight gain at week 34 8 1.0(0.4) 7 0.7(0.3) *0.68 [-0.29, 1.67]

Standley et al. (2010) weight gain at week 36 8 1.3(0.3) 6 1.5(0.6) -0.41 [-1.42, 0.58]

Note. * = Positive effect of treatment (where 0.0-0.3 has a small effect, 0.3-0.5 has a moderate effect and 0.5-1 has a large effect). To demonstrate

positive effects of reduced length of stay, outcomes relating to length of stay measures have been inverted from negative to positive.


Figure 16. Forest plot demonstrating the effects of interventions involving an environmental

change.

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