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Development of a parental report questionnaire for restless legs syndrome in young children: the p-RLSQ


* Angela Margaret Evans PhD 1,2

Sarah Lee Blunden PhD 3

Rachael Marie Spooner BPsych (Hons) 4

La Trobe University, Kingsbury Drive, Bundoora, Victoria, Australia
AUT University, North Shore Campus, Akoranga Drive, Auckland, New Zealand
Central Queensland University
University of South Australia, City East Campus, North Terrace, Adelaide, Australia.

* Corresponding author:  A. Evans:  HYPERLINK "mailto:angela.evans@latrobe.edu.au" angela.evans@latrobe.edu.au
P.O. Box 84, Oaklands Park, 5046, South Australia, Australia.
Facsimile: +61 8 82891377 Phone: +61 8 81721004


Keywords: sleep, restless legs, children, questionnaire, validated, triangulation
Abstract 

Background
Restless legs syndrome (RLS) is long reported, and a commonly presenting childhood complaint. Characterised by an irresistible urge to move the legs, RLS is often associated with noxious sensations, which are worse at rest and relieved by movement. The serious consequences of RLS may include: aggression, inattention, hyperactivity; poor school performance; poor social development and interactions, and the misdiagnoses of psychiatric illnesses, including attention deficit/hyperactivity disorder.
Methods
A process of triangulation was undertaken to gather information and develop concepts about RLS in children from three sources: the medical literature, parent interviews and a focus group of children. Internal validity and repeated measure reliability were assessed across two separate trials.
Results
From the parent interviews and children�s focus group, the themes identified by two independent experts yielded 71% agreement. The repeated measures reliability of the questionnaire from 40 completed responses returned ICC = 0.75 (95% CI  -0.17 � 0.98). 
Conclusions
The availability of this simple, validated instrument (p-RLSQ), now makes the specific study of RLS in children more feasible, and in conjunction with the existing Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS), may render more effective identification of children with RLS.Background
 Restless legs syndrome (RLS) is a frequently undiagnosed sensorimotor disorder that remains little understood, especially in children, in whom it is commonly reported  ADDIN PAPERS2_CITATIONS <citation><uuid>A1C5D8AD-67C5-4D31-B17F-A945E12C6871</uuid><priority>0</priority><publications><publication><volume>4</volume><publication_date>99200303001200000000220000</publication_date><number>2</number><institution>Department of Neurology, Sleep Medicine, Johns Hopkins Bayview Medical Center, Asthma and Allergy Building 1B46b, 5501 Hopkins Bayview Circle, Baltimore, MD 21224, USA. richardjhu@aol.com</institution><startpage>101</startpage><title>Restless legs syndrome: diagnostic criteria, special considerations, and epidemiology. A report from the restless legs syndrome diagnosis and epidemiology workshop at the National Institutes of Health.</title><uuid>4A2621D5-97B0-4F19-8C0D-9168E3085636</uuid><subtype>420</subtype><endpage>119</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=14592341&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><title>Sleep medicine</title><type>-200</type><subtype>-200</subtype><uuid>D25DB461-664F-4375-9F91-04BFF54D1AE5</uuid></publication></bundle><authors><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Daniel</firstName><lastName>Picchietti</lastName></author><author><firstName>Wayne</firstName><middleNames>A</middleNames><lastName>Hening</lastName></author><author><firstName>Claudia</firstName><lastName>Trenkwalder</lastName></author><author><firstName>Arthur</firstName><middleNames>S</middleNames><lastName>Walters</lastName></author><author><firstName>Jacques</firstName><lastName>Montplaisi</lastName></author><author><lastName>Restless Legs Syndrome Diagnosis and Epidemiology workshop at the National Institutes of Health</lastName></author><author><lastName>International Restless Legs Syndrome Study Group</lastName></author></authors></publication><publication><uuid>52D652D4-9CA9-4C46-B781-70E647F80D8A</uuid><volume>26</volume><accepted_date>99201008101200000000222000</accepted_date><doi>10.1002/mds.23430</doi><startpage>114</startpage><revision_date>99201005021200000000222000</revision_date><publication_date>99201101001200000000220000</publication_date><url>http://doi.wiley.com/10.1002/mds.23430</url><type>400</type><title>Prevalence and disease burden of primary restless legs syndrome: results of a general population survey in the United States.</title><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><submission_date>99200908111200000000222000</submission_date><number>1</number><institution>Department of Neurology, Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.</institution><subtype>400</subtype><endpage>120</endpage><bundle><publication><title>Movement disorders : official journal of the Movement Disorder Society</title><type>-100</type><subtype>-100</subtype><uuid>882CB70F-A76E-49E9-9CBD-60EA9C031C5E</uuid></publication></bundle><authors><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Murtuza</firstName><lastName>Bharmal</lastName></author><author><firstName>Michael</firstName><lastName>Calloway</lastName></author></authors></publication></publications><cites></cites></citation>(1,2). RLS is a long reported, commonly presenting childhood complaint characterised by an irresistible urge to move the legs, often associated with unpleasant sensations which are worse at rest and relieved by movement. These occurrences are usually late in the day or during the night, often disrupting sleep  ADDIN PAPERS2_CITATIONS <citation><uuid>B90FBE37-6303-40A2-A835-0F48AC4719C2</uuid><priority>0</priority><publications><publication><volume>64</volume><publication_date>99197503001200000000220000</publication_date><number>2</number><startpage>264</startpage><title>Growing pains and restless legs.</title><uuid>64722741-A308-4291-9458-554E91E551BD</uuid><subtype>400</subtype><endpage>266</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=1130184&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><title>Acta paediatrica Scandinavica</title><type>-100</type><subtype>-100</subtype><uuid>1B9A2D99-5AB7-4841-864A-4F1BDFB1E06A</uuid></publication></bundle><authors><author><firstName>K</firstName><middleNames>A</middleNames><lastName>Ekbom</lastName></author></authors></publication><publication><type>400</type><publication_date>99200800001200000000200000</publication_date><title>Growing pains and restless legs</title><url>http://www3.interscience.wiley.com/journal/120068277/abstract</url><subtype>400</subtype><uuid>79AEDA89-D2B7-44EF-8359-4D42034EE44F</uuid><bundle><publication><title>Acta P�diatrica</title><type>-100</type><subtype>-100</subtype><uuid>109E2356-FD81-4FCE-9E27-47C8FFF7A689</uuid></publication></bundle><authors><author><firstName>K</firstName><lastName>EKBOM</lastName></author></authors></publication></publications><cites></cites></citation>(3,4). Children with RLS are poorly managed and possibly not discriminated from growing pains, with which overlap may exist  ADDIN PAPERS2_CITATIONS <citation><uuid>FA7C9038-815C-4F3E-AD07-E6BFC3F6BD21</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200400001200000000200000</publication_date><title>Some children with growing pains may actually have restless legs syndrome</title><url>http://d.wanfangdata.com.cn/NSTLQK_NSTL_QK7992216.aspx</url><subtype>400</subtype><uuid>DEBF0078-78C2-4A01-B180-B97AF9FEC83F</uuid><bundle><publication><title>Sleep</title><type>-100</type><subtype>-100</subtype><uuid>BD6224ED-B37E-4EF9-BE8A-EF682EB4FEDF</uuid></publication></bundle><authors><author><firstName>S</firstName><lastName>Rajaram</lastName></author><author><firstName>A</firstName><lastName>Walters</lastName></author><author><firstName>S</firstName><lastName>England</lastName></author><author><firstName>D</firstName><lastName>Mehta</lastName></author></authors></publication></publications><cites></cites></citation>(5). The prevalence of RLS in children is unknown in Australia but has been estimated at 2.7%  ADDIN PAPERS2_CITATIONS <citation><uuid>85E3EFB9-C427-42E8-9557-3876449A0D96</uuid><priority>0</priority><publications><publication><uuid>3AE90745-A5D0-4367-8970-BBC926915D98</uuid><volume>12</volume><accepted_date>99201008291200000000222000</accepted_date><doi>10.1016/j.sleep.2010.08.013</doi><startpage>315</startpage><revision_date>99201008261200000000222000</revision_date><publication_date>99201104001200000000220000</publication_date><url>http://linkinghub.elsevier.com/retrieve/pii/S1389945711000037</url><type>400</type><title>A prevalence study of restless legs syndrome in Turkish children and adolescents.</title><location>&lt;html&gt;&lt;head&gt;&lt;meta http-equiv="content-type" content="text/html; charset=utf-8"/&gt;&lt;title&gt;Sorry...&lt;/title&gt;&lt;style&gt; body { font-family: verdana, arial, sans-serif; background-color: #fff; color: #000; }&lt;/style&gt;&lt;/head&gt;&lt;body&gt;&lt;div&gt;&lt;table&gt;&lt;tr&gt;&lt;td&gt;&lt;b&gt;&lt;font face=times color=#0039b6 size=10&gt;G&lt;/font&gt;&lt;font face=times color=#c41200 size=10&gt;o&lt;/font&gt;&lt;font face=times color=#f3c518 size=10&gt;o&lt;/font&gt;&lt;font face=times color=#0039b6 size=10&gt;g&lt;/font&gt;&lt;font face=times color=#30a72f size=10&gt;l&lt;/font&gt;&lt;font face=times color=#c41200 size=10&gt;e&lt;/font&gt;&lt;/b&gt;&lt;/td&gt;&lt;td style="text-align: left; vertical-align: bottom; padding-bottom: 15px; width: 50%"&gt;&lt;div style="border-bottom: 1px solid #dfdfdf;"&gt;Sorry...&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;&lt;/div&gt;&lt;div style="margin-left: 4em;"&gt;&lt;h1&gt;We're sorry...&lt;/h1&gt;&lt;p&gt;... but your computer or network may be sending automated queries. To protect our users, we can't process your request right now.&lt;/p&gt;&lt;/div&gt;&lt;div style="margin-left: 4em;"&gt;See &lt;a href="https://support.google.com/websearch/answer/86640"&gt;Google Help&lt;/a&gt; for more information.&lt;br/&gt;&lt;br/&gt;&lt;/div&gt;&lt;div style="text-align: center; border-top: 1px solid #dfdfdf;"&gt;&amp;copy; 2013 Google - &lt;a href="https://www.google.com"&gt;Google Home&lt;/a&gt;&lt;/div&gt;&lt;/body&gt;&lt;/html&gt;</location><submission_date>99201006141200000000222000</submission_date><number>4</number><institution>Marmara University, Institute of Neurological Sciences, Department of Pediatric Neurology, Maltepe-Basibuyuk, 34854 Istanbul, Turkey. dturkdogan@marmara.edu.tr</institution><subtype>400</subtype><endpage>321</endpage><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>Dil_ad</firstName><lastName>Turkdogan</lastName></author><author><firstName>Nural</firstName><lastName>Bekiroglu</lastName></author><author><firstName>Sennur</firstName><lastName>Zaimoglu</lastName></author></authors></publication></publications><cites></cites></citation>(6), and 5.9%  ADDIN PAPERS2_CITATIONS <citation><uuid>51BE7286-BCEE-42B3-8F62-C66F17F62CE6</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200700001200000000200000</publication_date><title>Restless Legs Syndrome: Prevalence and Impact in Children and Adolescents The Peds REST Study</title><url>http://pediatrics.aappublications.org/cgi/content/full/120/2/253?linkType=FULL&amp;journalCode=pediatrics&amp;resid=120/2/253</url><subtype>400</subtype><uuid>8322EBE5-1815-4AFE-82F6-AD42047887D0</uuid><bundle><publication><title>Pediatrics</title><type>-100</type><subtype>-100</subtype><uuid>9CAF935B-640C-4DBC-B0A0-559B3A0A8F94</uuid></publication></bundle><authors><author><firstName>D</firstName><lastName>Picchietti</lastName></author><author><firstName>R</firstName><lastName>Allen</lastName></author><author><firstName>A</firstName><lastName>Walters</lastName></author><author><firstName>J</firstName><lastName>Davidson</lastName></author></authors></publication></publications><cites></cites></citation>(7) elsewhere. Generally, the epidemiological data in children with RLS is very limited, despite increasing reports of RLS in children in the last ten years. Whilst RLS primarily affects adults, this point may be confused by the fact that it is also postulated that some presumed growing pains in childhood may actually be RLS  ADDIN PAPERS2_CITATIONS <citation><uuid>5D6C6545-81BC-4385-A20C-589D44370D30</uuid><priority>5</priority><publications><publication><uuid>1683BF9B-40FA-4098-8F19-F3CC24F71A2E</uuid><volume>16</volume><accepted_date>99201202101200000000222000</accepted_date><subtitle>A twin family study of growing pains and restless legs syndrome</subtitle><doi>10.1002/j.1532-2149.2012.00130.x</doi><startpage>1224</startpage><publication_date>99201210001200000000220000</publication_date><url>http://doi.wiley.com/10.1002/j.1532-2149.2012.00130.x</url><type>400</type><title>Growing pains: twin family study evidence for genetic susceptibility and a genetic relationship with restless legs syndrome.</title><institution>Department of Anaesthesia and Pain Medicine, Sydney Children's Hospital, Randwick, Australia. dchamp@bigpond.net.au</institution><number>9</number><subtype>400</subtype><endpage>1231</endpage><bundle><publication><title>European journal of pain (London, England)</title><type>-100</type><subtype>-100</subtype><uuid>7E428D9E-4036-430E-83B3-46F7FAA4EB68</uuid></publication></bundle><authors><author><firstName>D</firstName><lastName>Champion</lastName></author><author><firstName>S</firstName><lastName>Pathirana</lastName></author><author><firstName>C</firstName><lastName>Flynn</lastName></author><author><firstName>A</firstName><lastName>Taylor</lastName></author><author><firstName>J</firstName><middleNames>L</middleNames><lastName>Hopper</lastName></author><author><firstName>S</firstName><middleNames>F</middleNames><lastName>Berkovic</lastName></author><author><firstName>T</firstName><lastName>Jaaniste</lastName></author><author><firstName>W</firstName><lastName>Qiu</lastName></author></authors></publication><publication><type>400</type><publication_date>99200400001200000000200000</publication_date><title>Some children with growing pains may actually have restless legs syndrome</title><url>http://d.wanfangdata.com.cn/NSTLQK_NSTL_QK7992216.aspx</url><subtype>400</subtype><uuid>DEBF0078-78C2-4A01-B180-B97AF9FEC83F</uuid><bundle><publication><title>Sleep</title><type>-100</type><subtype>-100</subtype><uuid>BD6224ED-B37E-4EF9-BE8A-EF682EB4FEDF</uuid></publication></bundle><authors><author><firstName>S</firstName><lastName>Rajaram</lastName></author><author><firstName>A</firstName><lastName>Walters</lastName></author><author><firstName>S</firstName><lastName>England</lastName></author><author><firstName>D</firstName><lastName>Mehta</lastName></author></authors></publication><publication><type>400</type><publication_date>99200200001200000000200000</publication_date><title>Is there a subpopulation of children with growing pains who really have restless legs syndrome? A review of the literature</title><url>http://linkinghub.elsevier.com/retrieve/pii/S1389945701001642</url><subtype>400</subtype><uuid>AE7A8C73-C7F7-4F42-9E11-049B650A2F31</uuid><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>A</firstName><lastName>Walters</lastName></author></authors></publication></publications><cites></cites></citation>(5,8,9).  This unresolved debate has implications in terms of ongoing sleep disturbance and hence quality of life for affected individuals. Children with sleep disturbance, characteristic of RLS, can present with significant daytime somnolence from sleep loss that may arise from a difficulty initiating and maintaining sleep  ADDIN PAPERS2_CITATIONS <citation><uuid>86DD342C-0D41-4149-9A92-BC91C62E5D91</uuid><priority>0</priority><publications><publication><volume>64</volume><publication_date>99197503001200000000220000</publication_date><number>2</number><startpage>264</startpage><title>Growing pains and restless legs.</title><uuid>64722741-A308-4291-9458-554E91E551BD</uuid><subtype>400</subtype><endpage>266</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=1130184&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><title>Acta paediatrica Scandinavica</title><type>-100</type><subtype>-100</subtype><uuid>1B9A2D99-5AB7-4841-864A-4F1BDFB1E06A</uuid></publication></bundle><authors><author><firstName>K</firstName><middleNames>A</middleNames><lastName>Ekbom</lastName></author></authors></publication><publication><uuid>A7B75C13-6EEC-4934-869B-F763EE5F21C3</uuid><volume>56</volume><doi>10.1002/ana.20292</doi><startpage>803</startpage><publication_date>99200412001200000000220000</publication_date><url>http://doi.wiley.com/10.1002/ana.20292</url><type>400</type><title>Childhood-onset restless legs syndrome.</title><institution>Division of Child and Adolescent Neurology, Mayo Clinic, Rochester, MN, USA. kotagal.suresh@mayo.edu</institution><number>6</number><subtype>400</subtype><endpage>807</endpage><bundle><publication><title>Annals of neurology</title><type>-100</type><subtype>-100</subtype><uuid>0A9AF1C1-060B-4CE6-BCBE-9A297C7CEF69</uuid></publication></bundle><authors><author><firstName>Suresh</firstName><lastName>Kotagal</lastName></author><author><firstName>Michael</firstName><middleNames>H</middleNames><lastName>Silber</lastName></author></authors></publication></publications><cites></cites></citation>(3,10)
The consequences of RLS are serious and may include: behavioural problems including aggression, inattention, hyperactivity; unsatisfactory performance in school; poor social development; abnormal social interactions and incorrect diagnoses of various psychiatric illnesses, including attention deficit/hyperactivity disorder (ADHD)  ADDIN PAPERS2_CITATIONS <citation><uuid>178EA55E-F34B-4F41-8A91-D0B3D66BCDFB</uuid><priority>0</priority><publications><publication><uuid>94C7EE9E-7DEA-4F87-B49C-B7B6E077EB89</uuid><volume>17</volume><accepted_date>99201104011200000000222000</accepted_date><startpage>1436</startpage><publication_date>99201100001200000000200000</publication_date><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=21476956&amp;retmode=ref&amp;cmd=prlinks</url><type>400</type><title>Restless legs syndrome in children: a review and update on pharmacological options.</title><submission_date>99201103291200000000222000</submission_date><number>15</number><institution>University of Sherbrooke, Sherbrooke, QC, J1H 5N4, Canada. eric.frenette@usherbrooke.ca</institution><subtype>400</subtype><endpage>1442</endpage><bundle><publication><title>Current pharmaceutical design</title><type>-100</type><subtype>-100</subtype><uuid>F9177A77-9A3E-478F-84B8-CDFF574E29AE</uuid></publication></bundle><authors><author><firstName>Eric</firstName><lastName>Frenette</lastName></author></authors></publication><publication><volume>25</volume><publication_date>99200203151200000000222000</publication_date><number>2</number><institution>Sleep Disorders Center, Department of Neurology, University of Michigan, Ann Arbor, USA. chervin@umich.edu</institution><startpage>213</startpage><title>Associations between symptoms of inattention, hyperactivity, restless legs, and periodic leg movements.</title><uuid>7B95B2D8-69B3-4B32-8080-A78AA2C71043</uuid><subtype>400</subtype><endpage>218</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=11902431&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><title>Sleep</title><type>-100</type><subtype>-100</subtype><uuid>BD6224ED-B37E-4EF9-BE8A-EF682EB4FEDF</uuid></publication></bundle><authors><author><firstName>Ronald</firstName><middleNames>D</middleNames><lastName>Chervin</lastName></author><author><firstName>Kristen</firstName><middleNames>Hedger</middleNames><lastName>Archbold</lastName></author><author><firstName>James</firstName><middleNames>E</middleNames><lastName>Dillon</lastName></author><author><firstName>Kenneth</firstName><middleNames>J</middleNames><lastName>Pituch</lastName></author><author><firstName>Parviz</firstName><lastName>Panahi</lastName></author><author><firstName>Ronald</firstName><middleNames>E</middleNames><lastName>Dahl</lastName></author><author><firstName>Christian</firstName><lastName>Guilleminault</lastName></author></authors></publication></publications><cites></cites></citation>(11,12). As noted, sleep disruption, including increased sleep latency and sleep maintenance insomnia, has been reported in children with RLS. There is much evidence for the deleterious effects of sleep loss on daytime function in children, and given the potential for RLS to disrupt sleep, this may be implicated in daytime deficits. Treatment for RLS is hence important, not only due to immediate effects on functioning but because those children affected may suffer throughout their adult lives  ADDIN PAPERS2_CITATIONS <citation><uuid>CAC4A0F6-A02E-4CB5-8C20-D4DF46A1DDC0</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200400001200000000200000</publication_date><title>Some children with growing pains may actually have restless legs syndrome</title><url>http://d.wanfangdata.com.cn/NSTLQK_NSTL_QK7992216.aspx</url><subtype>400</subtype><uuid>DEBF0078-78C2-4A01-B180-B97AF9FEC83F</uuid><bundle><publication><title>Sleep</title><type>-100</type><subtype>-100</subtype><uuid>BD6224ED-B37E-4EF9-BE8A-EF682EB4FEDF</uuid></publication></bundle><authors><author><firstName>S</firstName><lastName>Rajaram</lastName></author><author><firstName>A</firstName><lastName>Walters</lastName></author><author><firstName>S</firstName><lastName>England</lastName></author><author><firstName>D</firstName><lastName>Mehta</lastName></author></authors></publication><publication><uuid>1DBD6C5D-F834-4EA2-A1D4-D02A0CD0CA7D</uuid><doi>10.1016/j.jns.2013.11.001</doi><accepted_date>99201311011200000000222000</accepted_date><revision_date>99201310281200000000222000</revision_date><publication_date>99201311111200000000222000</publication_date><url>http://linkinghub.elsevier.com/retrieve/pii/S0022510X13030141</url><type>400</type><title>Daytime dysfunction in children with restless legs syndrome.</title><publisher>Elsevier</publisher><submission_date>99201309041200000000222000</submission_date><institution>Department of Somnology, Tokyo Medical University, Tokyo, Japan; Department of Psychiatry, Tokyo Medical University, Tokyo, Japan.</institution><subtype>400</subtype><bundle><publication><title>Journal of the neurological sciences</title><type>-100</type><subtype>-100</subtype><uuid>25BA1F17-DAB6-4816-A40F-0043E2B1C5D1</uuid></publication></bundle><authors><author><firstName>Naomichi</firstName><lastName>Furudate</lastName></author><author><firstName>Yoko</firstName><lastName>Komada</lastName></author><author><firstName>Mina</firstName><lastName>Kobayashi</lastName></author><author><firstName>Shun</firstName><lastName>Nakajima</lastName></author><author><firstName>Yuichi</firstName><lastName>Inoue</lastName></author></authors></publication></publications><cites></cites></citation>(5,13).
The International Restless Legs Syndrome Study Group has developed standardized criteria for the diagnosis of definite, probable and possible restless legs syndrome in children in an effort to facilitate the undertaking of epidemiological studies of RLS in children  ADDIN PAPERS2_CITATIONS <citation><uuid>DA67DEF3-799F-4EB3-BAC7-4595D64263FD</uuid><priority>0</priority><publications><publication><volume>4</volume><publication_date>99200303001200000000220000</publication_date><number>2</number><institution>New Jersey Neuroscience Institute, JFK Medical Center, Edison, NJ 08818, USA. artumdnj@aol.com</institution><startpage>121</startpage><title>Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome.</title><uuid>25F04639-5BDE-42E2-BF2B-747A5AF380E3</uuid><subtype>400</subtype><endpage>132</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=14592342&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>Arthur</firstName><middleNames>S</middleNames><lastName>Walters</lastName></author><author><firstName>Cheryl</firstName><lastName>LeBrocq</lastName></author><author><firstName>Anjana</firstName><lastName>Dhar</lastName></author><author><firstName>Wayne</firstName><lastName>Hening</lastName></author><author><firstName>Ray</firstName><lastName>Rosen</lastName></author><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Claudia</firstName><lastName>Trenkwalder</lastName></author><author><lastName>International Restless Legs Syndrome Study Group</lastName></author></authors></publication></publications><cites></cites></citation>(14).  The stipulated criteria are:
1. An urge to move the limbs usually associated with paraesthesias/dysthesias
2. Motor restlessness
3. Symptoms begin or are worse with rest, relieved partially or totally by activity
4. Symptoms worse in the evening or night
There is a need for a valid and reliable instrument that can identify RLS in children. It is known that young children up to approximately eight to ten years of age find self report difficult  ADDIN PAPERS2_CITATIONS <citation><uuid>EE500222-158E-49A8-9F53-A63A071456AD</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200100001200000000200000</publication_date><title>The health and well-being of adolescents: a school-based population study of the self-report Child Health Questionnaire</title><url>http://www.sciencedirect.com/science/article/pii/S1054139X01002117</url><subtype>400</subtype><uuid>91D59493-E154-44E7-93EB-F295432AAA61</uuid><bundle><publication><title>Journal of adolescent �</title><type>-100</type><subtype>-100</subtype><uuid>3E5180DE-C56C-4FB2-BCED-7BF90D041EA0</uuid></publication></bundle><authors><author><firstName>E</firstName><middleNames>B</middleNames><lastName>Waters</lastName></author><author><firstName>L</firstName><middleNames>A</middleNames><lastName>Salmon</lastName></author><author><firstName>M</firstName><lastName>Wake</lastName></author><author><firstName>M</firstName><lastName>Wright</lastName></author></authors></publication><publication><type>400</type><publication_date>99200300001200000000200000</publication_date><title>The Koala Fear Questionnaire: a standardized self-report scale for assessing fears and fearfulness in pre-school and primary school children</title><url>http://www.sciencedirect.com/science/article/pii/S0005796702000980</url><subtype>400</subtype><uuid>107CE77E-C525-4914-A31B-83510DBDCFB7</uuid><bundle><publication><title>Behaviour research and �</title><type>-100</type><subtype>-100</subtype><uuid>9D5E2D50-E991-4F0E-BEC9-5FF8F321F269</uuid></publication></bundle><authors><author><firstName>P</firstName><lastName>Muris</lastName></author><author><firstName>C</firstName><lastName>Meesters</lastName></author><author><firstName>B</firstName><lastName>Mayer</lastName></author><author><firstName>N</firstName><lastName>Bogie</lastName></author></authors></publication></publications><cites></cites></citation>(15,16). As there exists a self-report questionnaire for adolescent RLS  ADDIN PAPERS2_CITATIONS <citation><uuid>D0EE8DE6-93FC-4CFE-9197-C295E0123A58</uuid><priority>0</priority><publications><publication><uuid>19D4B33E-2385-4D34-8FF7-378B54CF385B</uuid><volume>11</volume><accepted_date>99201003251200000000222000</accepted_date><doi>10.1016/j.sleep.2010.03.016</doi><startpage>897</startpage><revision_date>99201003191200000000222000</revision_date><publication_date>99201010001200000000220000</publication_date><url>http://linkinghub.elsevier.com/retrieve/pii/S1389945710002480</url><type>400</type><title>Development of the Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS): a patient-reported outcome measure of pediatric RLS symptoms and impact.</title><location>&lt;html&gt;&lt;head&gt;&lt;meta http-equiv="content-type" content="text/html; charset=utf-8"/&gt;&lt;title&gt;Sorry...&lt;/title&gt;&lt;style&gt; body { font-family: verdana, arial, sans-serif; background-color: #fff; color: #000; }&lt;/style&gt;&lt;/head&gt;&lt;body&gt;&lt;div&gt;&lt;table&gt;&lt;tr&gt;&lt;td&gt;&lt;b&gt;&lt;font face=times color=#0039b6 size=10&gt;G&lt;/font&gt;&lt;font face=times color=#c41200 size=10&gt;o&lt;/font&gt;&lt;font face=times color=#f3c518 size=10&gt;o&lt;/font&gt;&lt;font face=times color=#0039b6 size=10&gt;g&lt;/font&gt;&lt;font face=times color=#30a72f size=10&gt;l&lt;/font&gt;&lt;font face=times color=#c41200 size=10&gt;e&lt;/font&gt;&lt;/b&gt;&lt;/td&gt;&lt;td style="text-align: left; vertical-align: bottom; padding-bottom: 15px; width: 50%"&gt;&lt;div style="border-bottom: 1px solid #dfdfdf;"&gt;Sorry...&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;&lt;/div&gt;&lt;div style="margin-left: 4em;"&gt;&lt;h1&gt;We're sorry...&lt;/h1&gt;&lt;p&gt;... but your computer or network may be sending automated queries. To protect our users, we can't process your request right now.&lt;/p&gt;&lt;/div&gt;&lt;div style="margin-left: 4em;"&gt;See &lt;a href="https://support.google.com/websearch/answer/86640"&gt;Google Help&lt;/a&gt; for more information.&lt;br/&gt;&lt;br/&gt;&lt;/div&gt;&lt;div style="text-align: center; border-top: 1px solid #dfdfdf;"&gt;&amp;copy; 2013 Google - &lt;a href="https://www.google.com"&gt;Google Home&lt;/a&gt;&lt;/div&gt;&lt;/body&gt;&lt;/html&gt;</location><submission_date>99201001201200000000222000</submission_date><number>9</number><institution>Mapi Values Ltd., Cheshire, United Kingdom. rob.arbuckle@mapivalues.com</institution><subtype>400</subtype><endpage>906</endpage><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>Robert</firstName><lastName>Arbuckle</lastName></author><author><firstName>Linda</firstName><lastName>Abetz</lastName></author><author><firstName>Jeffrey</firstName><middleNames>S</middleNames><lastName>Durmer</lastName></author><author><firstName>Anna</firstName><lastName>Ivanenko</lastName></author><author><firstName>Judith</firstName><middleNames>A</middleNames><lastName>Owens</lastName></author><author><firstName>Jens</firstName><lastName>Croenlein</lastName></author><author><firstName>Kate</firstName><lastName>Bolton</lastName></author><author><firstName>Adam</firstName><lastName>Moore</lastName></author><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Arthur</firstName><middleNames>S</middleNames><lastName>Walters</lastName></author><author><firstName>Daniel</firstName><middleNames>L</middleNames><lastName>Picchietti</lastName></author></authors></publication></publications><cites></cites></citation>(17), a parental report questionnaire was needed to complement this and to expand the potential for screening those children under ten years of age.  It was decided to develop a RLS questionnaire to be completed by parental report that could be utilised for all age groups, an in particular younger children. 
Therefore, the aim of this study was to develop and validate a parental report questionnaire, to identify RLS, in children. The significance of this project is that RLS in children would then be more easily identified, and potentially managed.


Materials and Methods
Ethical approval was obtained from the Human Ethics Research Committee at the University of South Australia and all participating subjects (parents) completed informed consent declarations.

A process of triangulation  ADDIN PAPERS2_CITATIONS <citation><uuid>C954A036-4E9F-45A2-B0B4-D25FD361D867</uuid><priority>0</priority><publications><publication><publication_date>99199201011200000000222000</publication_date><startpage>303</startpage><title>Questionnaire Design, Interviewing, and Attitude Measurement</title><uuid>D382FD18-C6B8-4FD3-9381-F45C373BF34A</uuid><subtype>0</subtype><publisher>Burns &amp; Oates</publisher><type>0</type><url>http://books.google.com.au/books?id=W_gXkgEACAAJ&amp;dq=inauthor:oppenheim+an+(1992+inpublisher:pinter+publishers)&amp;hl=&amp;cd=1&amp;source=gbs_api</url><authors><author><firstName>Abraham</firstName><middleNames>Naftali</middleNames><lastName>Oppenheim</lastName></author></authors></publication></publications><cites></cites></citation>(18) was undertaken to gather information and develop concepts about RLS in children from three important sources: the medical literature, parent interviews and a focus group for children. Interviews were continued until the forthcoming information was saturated ie no new data emerged. The interviews and focus group discussions were transcribed, for review by independent experts (viz. paediatric psychologists or sleep technicians). To ensure the internal validity of the questionnaire, themes were identified from each of these sources by the two independent experts and converted to the instrument scales. The reliability of the questionnaire was examined using a same subject, repeated measures study. To gain sufficient responses, two separate trials were conducted.

Literature review
The medical and allied health literature was searched to retrieve the recurring themes about RLS that have been reported. 
Databases searched included MEDLINE [Ovid], MEDLINE In-Process [Ovid], EMBASE [Ovid], CAB [Ovid], Health Management Information Consortium [Ovid], The Cochrane Database of Systematic Reviews, Cochrane Register of Controlled Trials, Science Citation Index Expanded [Web of Science], Conference Proceedings Citation Index [The Web of Science], Database of Abstract Reviews [CRD; Centre for Reviews and Dissemination], HTA [CRD], PsycINFO [Ebsco], NHS CRD. To locate additional papers relevant journals and article reference lists were hand-searched as well as searching sleep institution websites and discussions with experts in the field.

Interviews
Once themes regarding RLS in children were identified from the literature, exploratory interviews were conducted with parents of children with reported symptoms of RLS, using the international RLS study group criteria  ADDIN PAPERS2_CITATIONS <citation><uuid>94237D9F-745D-44CA-B9B7-F4546A3B9905</uuid><priority>0</priority><publications><publication><volume>4</volume><publication_date>99200303001200000000220000</publication_date><number>2</number><institution>New Jersey Neuroscience Institute, JFK Medical Center, Edison, NJ 08818, USA. artumdnj@aol.com</institution><startpage>121</startpage><title>Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome.</title><uuid>25F04639-5BDE-42E2-BF2B-747A5AF380E3</uuid><subtype>400</subtype><endpage>132</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=14592342&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>Arthur</firstName><middleNames>S</middleNames><lastName>Walters</lastName></author><author><firstName>Cheryl</firstName><lastName>LeBrocq</lastName></author><author><firstName>Anjana</firstName><lastName>Dhar</lastName></author><author><firstName>Wayne</firstName><lastName>Hening</lastName></author><author><firstName>Ray</firstName><lastName>Rosen</lastName></author><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Claudia</firstName><lastName>Trenkwalder</lastName></author><author><lastName>International Restless Legs Syndrome Study Group</lastName></author></authors></publication></publications><cites></cites></citation>(14). This enabled data collection from subjects with unique knowledge and experiential stories, which is essential for the development of a relevant questionnaire. Whilst the interviews were guided by questions from the literature-based themes, the questions were also as exploratory and free-form as possible, so that information was elicited with the least influence of the interviewing researcher. The interviews were tape recorded and later transcribed by a person who was neutral and blinded to the research project. The interviews were conducted until the information arising became saturated ie there were no new data arising. A post-interview check of the information retrieved from each subject interviewed was incorporated as part of the internal validity analysis ie the subject�s responses were re-checked at the end of the interviews to assess consistency of the given responses. The transcriptions were read and the themes identified by two independent people with expertise in the fields of paediatric sleep and psychology. This process further provided the strength of internal validity of the themes emerging from the raw interview data, which formed the skeleton of the questionnaire.

Focus group
Children who were seen at a paediatric sleep clinic in Adelaide, South Australia and known to have reported symptoms of RLS (international RLS study group criteria  ADDIN PAPERS2_CITATIONS <citation><uuid>328C523C-EB10-443F-8940-ED6773AA3194</uuid><priority>0</priority><publications><publication><volume>4</volume><publication_date>99200303001200000000220000</publication_date><number>2</number><institution>New Jersey Neuroscience Institute, JFK Medical Center, Edison, NJ 08818, USA. artumdnj@aol.com</institution><startpage>121</startpage><title>Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome.</title><uuid>25F04639-5BDE-42E2-BF2B-747A5AF380E3</uuid><subtype>400</subtype><endpage>132</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=14592342&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>Arthur</firstName><middleNames>S</middleNames><lastName>Walters</lastName></author><author><firstName>Cheryl</firstName><lastName>LeBrocq</lastName></author><author><firstName>Anjana</firstName><lastName>Dhar</lastName></author><author><firstName>Wayne</firstName><lastName>Hening</lastName></author><author><firstName>Ray</firstName><lastName>Rosen</lastName></author><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Claudia</firstName><lastName>Trenkwalder</lastName></author><author><lastName>International Restless Legs Syndrome Study Group</lastName></author></authors></publication></publications><cites></cites></citation>(14)), were invited to participate in a focus group that was structured along the same lines as the parent interviews (ie, based on literature themes). The focus group was recorded on videotape to facilitate identification of the subject�s responses by the transcriber, as young children�s voices are often indistinguishable from each other, particularly when engaged in a group discussion. Following transcription the themes were again identified by the two same independent experts and added to the preliminary questionnaire construction. 

The identified themes became the questions incorporated into the developing instrument. Care was taken with the order of the items to start with obviously relevant questions. Additionally, factual questions were used first and then attitude or searching questions followed when the respondents were more engaged with the topic. A mix of open and closed questions, and funnel and filter techniques (e.g.�can you specify your child�s complaints?� or �was activity always associated?�) were used with demographic and personal information being last  ADDIN PAPERS2_CITATIONS <citation><uuid>31CB6CB6-5B7B-4992-9B87-9062B1728538</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200400001200000000200000</publication_date><title>Development of a questionnaire for parental rating of leg pain in young children: internal validity and reliability testing following triangulation</title><url>http://www.sciencedirect.com/science/article/pii/S0958259203000725</url><subtype>400</subtype><uuid>F15BC00F-09ED-4F1D-8672-64279BFE3C68</uuid><bundle><publication><publisher>Elsevier Ltd</publisher><title>The Foot</title><type>-100</type><subtype>-100</subtype><uuid>6A9105CB-E3F4-49F9-BD5F-0B0F563BD39F</uuid></publication></bundle><authors><author><firstName>A</firstName><middleNames>M</middleNames><lastName>Evans</lastName></author><author><firstName>S</firstName><middleNames>D</middleNames><lastName>Scutter</lastName></author></authors></publication><publication><type>400</type><publication_date>99200300001200000000200000</publication_date><title>[CITATION][C]</title><url>http://scholar.google.com/scholar?q=related:IKZvFZYxXTwJ:scholar.google.com/&amp;hl=en&amp;num=20&amp;as_sdt=0,5&amp;as_ylo=2003&amp;as_yhi=2003</url><subtype>400</subtype><uuid>14109BB6-97D8-471B-B33B-D2FFF9C9E95B</uuid><bundle><publication><title>Quality of Life Research</title><type>-100</type><subtype>-100</subtype><uuid>448A4FBE-2ACA-43CF-A5FB-6F01F12BF0CA</uuid></publication></bundle><authors><author><firstName>A</firstName><middleNames>M</middleNames><lastName>Evans</lastName></author><author><firstName>S</firstName><middleNames>D</middleNames><lastName>Scutter</lastName></author><author><firstName>L</firstName><middleNames>M</middleNames><lastName>Lang</lastName></author></authors></publication><publication><type>400</type><publication_date>99200600001200000000200000</publication_date><title>�Growing pains� in young children: A study of the profile, experiences and quality of life issues of four to six year old children with recurrent leg pain</title><url>http://www.sciencedirect.com/science/article/pii/S0958259206000289</url><subtype>400</subtype><uuid>F7948993-9D8C-42FD-AA92-27823C62FE23</uuid><bundle><publication><publisher>Elsevier Ltd</publisher><title>The Foot</title><type>-100</type><subtype>-100</subtype><uuid>6A9105CB-E3F4-49F9-BD5F-0B0F563BD39F</uuid></publication></bundle><authors><author><firstName>A</firstName><middleNames>M</middleNames><lastName>Evans</lastName></author><author><firstName>S</firstName><middleNames>D</middleNames><lastName>Scutter</lastName></author><author><firstName>LMG</firstName><lastName>Lang</lastName></author><author><firstName>B</firstName><middleNames>R</middleNames><lastName>Dansie</lastName></author></authors></publication></publications><cites></cites></citation>(19-21)

Reliability study
Primary schools in metropolitan Adelaide, South Australia who had a pre-existing relationship with the authors, were approached and consented to participate in the reliability testing of the questionnaire. In order to assess the reliability of responses, a repeated parent response to the questionnaire was conducted viz. the questionnaires were distributed and initial responses were received. After a period of two weeks the questionnaire was distributed again to the parents who had responded the first time. The results from the repeated questionnaire returns were analysed to ascertain the reliability of the developed survey instrument. Only parents of children aged eight and nine years of age received the questionnaire.

Data analysis
Data were entered into Microsoft Excel and SPSS (version 19) for analysis. Internal validity of the interviews and focus group were assessed by the post-interview check. The two independent assessors identified themes from reading of the transcriptions. All data were ordinal and hence expressed as percent agreement.
Reliability of the questionnaire used in Trial 1 was assessed by examination of repeated response scores. All analyses of categorical data were expressed as non-parametric correlations ie Spearman�s rho. Analyses of continuous data utilised Pearson�s r score. Analysis of reliability in Trial 2 was performed using the intraclass correlation (ICC) within 95% confidence intervals  ADDIN PAPERS2_CITATIONS <citation><uuid>27277238-5EEF-4D19-9B76-212DD3CC64DA</uuid><priority>0</priority><publications><publication><publication_date>99200900001200000000200000</publication_date><startpage>892</startpage><subtitle>Applications to Practice: International Edition</subtitle><title>Foundations of Clinical Research</title><uuid>8875E0DC-8F18-4AEC-BF07-31D0FA23078E</uuid><subtype>1</subtype><type>0</type><url>http://books.google.com.au/books?id=t6tJPgAACAAJ&amp;dq=inauthor:portney+inauthor:watkins&amp;hl=&amp;cd=1&amp;source=gbs_api</url><authors><author><firstName>Leslie</firstName><middleNames>Gross</middleNames><lastName>Portney</lastName></author><author><firstName>Mary</firstName><middleNames>P</middleNames><lastName>Watkins</lastName></author></authors></publication></publications><cites></cites></citation>(22).

Results
Literature review
The themes identified from the reviewed literature were:
sleep disturbance (including inability to initiate sleep or difficulty maintaining sleep)
characteristics of RLS (constant leg movement, sensory descriptions, family patterns)
daytime somnolence 
behavioural problems and school performance 
poor social development and interactions 
confusion/overlap with attention deficit/hyperactivity disorder

Interviews
Six interviews were conducted involving seven parents, as both parents were present for one interview. The interviews covered the parent�s accounts of RLS in six children (two girls, four boys) all aged between eight and nine years. Internal validity checks post-interview showed good internal consistency of interview data. The themes identified by the two independent experts also yielded good agreement with average percent agreement of 71% (Table 1).

Focus group
The focus group was conducted with three children (boys) aged eight, nine and 10 years respectively. The focus group added a further theme (sleepy, tired, annoyed, grumpy during the day) to those already identified by the interviews and also reinforced and expanded some language expression, as that additional theme indicates. Again, internal validity check at the end of focus group discussion showed good internal consistency of the children�s response data. 

Reliability study
- Trial 1
The final questionnaire utilised in Trial 1 consisted of 13 questions and was distributed to a convenient primary school for the parent group of children aged eight and nine years. Initially, 74 questionnaires were distributed and 19 responses were received (25.7% response rate). After a period of two weeks the questionnaire was distributed again to the 19 parents who had responded the first time. The second round distribution to those 19 responding parents resulted in 11 returns (57.9%). The 11 repeated returns were analysed to ascertain the preliminary reliability of the developed instrument. 
The Trial 1 questionnaire, consisted of 13 questions (made up of 30 sub-part questions). The reliability of the questionnaire demonstrated an average correlation of rho = 0.556 with a complete range (rho = 0.0 � 1.0) across the 13 questions. Generally, the reliability of the questionnaire was good, the average non-parametric correlation was rho= 0.556.  Table 2 shows the reliability results from trial 1, which was hereafter regarded as a pilot and feasibility study. The questionnaire used for the main trial is attached as an appended file (Supplementary file).
- Trial 2
Acknowledging the poor total repeated responses (11/74) in Trial 1, a further reliability trial was undertaken (Trial 2). Three convenient primary schools were approached and agreed to be involved in the second trial. The ages of the children whose parents participated were again eight and nine years. The repeated response rates were: school 1 � 40 questionnaires distributed, first round responses 6, repeated responses 3; school 2 � 112 questionnaires distributed, first round responses 20, repeated responses 14; school 3 � 170 questionnaires distributed, first round responses 31, repeated responses 23. In total, the second trial yielded 40 repeated responses for reliability analysis (Table 3). The overall results returned an average questionnaire reliability of ICC = 0.75 (95% CI range -0.17 � 0.98). As shown in Table 4, 14 of the 21 questions/part-questions returned reliability of ICC > 0.75.

Discussion
This study was undertaken to develop a parental report questionnaire to assist in the diagnosis of RLS in children of all ages. RLS is a debilitating syndrome which can have significantly deleterious effects on children�s sleep and subsequent cognitive function, daytime behaviour, and psychosocial development  ADDIN PAPERS2_CITATIONS <citation><uuid>957FCFA4-A14F-4A30-B4C2-C1136A722EDD</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200700001200000000200000</publication_date><title>Restless Legs Syndrome: Prevalence and Impact in Children and Adolescents The Peds REST Study</title><url>http://pediatrics.aappublications.org/cgi/content/full/120/2/253?linkType=FULL&amp;journalCode=pediatrics&amp;resid=120/2/253</url><subtype>400</subtype><uuid>8322EBE5-1815-4AFE-82F6-AD42047887D0</uuid><bundle><publication><title>Pediatrics</title><type>-100</type><subtype>-100</subtype><uuid>9CAF935B-640C-4DBC-B0A0-559B3A0A8F94</uuid></publication></bundle><authors><author><firstName>D</firstName><lastName>Picchietti</lastName></author><author><firstName>R</firstName><lastName>Allen</lastName></author><author><firstName>A</firstName><lastName>Walters</lastName></author><author><firstName>J</firstName><lastName>Davidson</lastName></author></authors></publication></publications><cites></cites></citation>(7). Despite the existence of �gold standard� criteria  ADDIN PAPERS2_CITATIONS <citation><uuid>A019CE52-0EDD-4FB5-8CFC-B9C6E5420E26</uuid><priority>0</priority><publications><publication><volume>4</volume><publication_date>99200303001200000000220000</publication_date><number>2</number><institution>New Jersey Neuroscience Institute, JFK Medical Center, Edison, NJ 08818, USA. artumdnj@aol.com</institution><startpage>121</startpage><title>Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome.</title><uuid>25F04639-5BDE-42E2-BF2B-747A5AF380E3</uuid><subtype>400</subtype><endpage>132</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=14592342&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>Arthur</firstName><middleNames>S</middleNames><lastName>Walters</lastName></author><author><firstName>Cheryl</firstName><lastName>LeBrocq</lastName></author><author><firstName>Anjana</firstName><lastName>Dhar</lastName></author><author><firstName>Wayne</firstName><lastName>Hening</lastName></author><author><firstName>Ray</firstName><lastName>Rosen</lastName></author><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Claudia</firstName><lastName>Trenkwalder</lastName></author><author><lastName>International Restless Legs Syndrome Study Group</lastName></author></authors></publication></publications><cites></cites></citation>(14), there has been no validated parental report instrument to accurately identify RLS as a discrete condition. This study has developed and validated an instrument for this purpose � the parentally reported paediatric RLS questionnaire (p-RLSQ) which showed a good internal validity and test retest reliability. No cognitive review of the questionnaire was performed, which must be considered a current limitation of this tool, and a future step in refinement  ADDIN PAPERS2_CITATIONS <citation><uuid>B9ACECE2-863E-4B94-AF4A-D038722EB0CE</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99199900001200000000200000</publication_date><title>Quality of life and Parkinson's disease: translation and validation of the US Parkinson's Disease Questionnaire (PDQ-39)</title><url>http://link.springer.com/article/10.1023/A:1008979705027</url><subtype>400</subtype><uuid>5715A460-F28F-488E-9071-233CA88ED5B2</uuid><bundle><publication><title>Quality of Life Research</title><type>-100</type><subtype>-100</subtype><uuid>448A4FBE-2ACA-43CF-A5FB-6F01F12BF0CA</uuid></publication></bundle><authors><author><firstName>D</firstName><middleNames>M</middleNames><lastName>Bushnell</lastName></author><author><firstName>M</firstName><middleNames>L</middleNames><lastName>Martin</lastName></author></authors></publication><publication><type>400</type><publication_date>99200100001200000000200000</publication_date><title>Development of the 25-item national eye institute visual function questionnaire</title><url>http://archopht.ama-assn.org/cgi/reprint/119/7/1050.pdf</url><subtype>400</subtype><uuid>6BF75C3D-4C70-4181-BDA8-D509E8E4D118</uuid><bundle><publication><title>Archives of �</title><type>-100</type><subtype>-100</subtype><uuid>3B9683AF-4A19-4836-863C-9B1282FAD8B0</uuid></publication></bundle><authors><author><firstName>C</firstName><middleNames>M</middleNames><lastName>Mangione</lastName></author><author><firstName>P</firstName><middleNames>P</middleNames><lastName>Lee</lastName></author><author><firstName>P</firstName><middleNames>R</middleNames><lastName>Gutierrez</lastName></author></authors></publication></publications><cites></cites></citation>(23,24)

The development of this specific questionnaire for RLS in children may also assist in distinguishing this condition from the more prevalent, if less morbid, paediatric leg pain entity of growing pains. For some time there has been debate as to whether RLS is a sub-type of growing pains  ADDIN PAPERS2_CITATIONS <citation><uuid>44C19D19-0C86-41DF-9A22-C2AB21F1E1FB</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200400001200000000200000</publication_date><title>Development of a questionnaire for parental rating of leg pain in young children: internal validity and reliability testing following triangulation</title><url>http://www.sciencedirect.com/science/article/pii/S0958259203000725</url><subtype>400</subtype><uuid>F15BC00F-09ED-4F1D-8672-64279BFE3C68</uuid><bundle><publication><publisher>Elsevier Ltd</publisher><title>The Foot</title><type>-100</type><subtype>-100</subtype><uuid>6A9105CB-E3F4-49F9-BD5F-0B0F563BD39F</uuid></publication></bundle><authors><author><firstName>A</firstName><middleNames>M</middleNames><lastName>Evans</lastName></author><author><firstName>S</firstName><middleNames>D</middleNames><lastName>Scutter</lastName></author></authors></publication></publications><cites></cites></citation>(19) or whether it is a distinct condition. This questionnaire (p-RLSQ) used in conjunction with the existing questionnaire for growing pains (USAGPQ)  ADDIN PAPERS2_CITATIONS <citation><uuid>1BC9C5DC-2622-46AB-8B32-AE22D2FD5742</uuid><priority>0</priority><publications><publication><type>400</type><publication_date>99200400001200000000200000</publication_date><title>Development of a questionnaire for parental rating of leg pain in young children: internal validity and reliability testing following triangulation</title><url>http://www.sciencedirect.com/science/article/pii/S0958259203000725</url><subtype>400</subtype><uuid>F15BC00F-09ED-4F1D-8672-64279BFE3C68</uuid><bundle><publication><publisher>Elsevier Ltd</publisher><title>The Foot</title><type>-100</type><subtype>-100</subtype><uuid>6A9105CB-E3F4-49F9-BD5F-0B0F563BD39F</uuid></publication></bundle><authors><author><firstName>A</firstName><middleNames>M</middleNames><lastName>Evans</lastName></author><author><firstName>S</firstName><middleNames>D</middleNames><lastName>Scutter</lastName></author></authors></publication></publications><cites></cites></citation>(19) may assist in better differentiation of these two childhood problems, as may genetic patterns  ADDIN PAPERS2_CITATIONS <citation><uuid>4866E0BF-8195-4A85-802C-05C946F86350</uuid><priority>0</priority><publications><publication><uuid>1683BF9B-40FA-4098-8F19-F3CC24F71A2E</uuid><volume>16</volume><accepted_date>99201202101200000000222000</accepted_date><subtitle>A twin family study of growing pains and restless legs syndrome</subtitle><doi>10.1002/j.1532-2149.2012.00130.x</doi><startpage>1224</startpage><publication_date>99201210001200000000220000</publication_date><url>http://doi.wiley.com/10.1002/j.1532-2149.2012.00130.x</url><type>400</type><title>Growing pains: twin family study evidence for genetic susceptibility and a genetic relationship with restless legs syndrome.</title><institution>Department of Anaesthesia and Pain Medicine, Sydney Children's Hospital, Randwick, Australia. dchamp@bigpond.net.au</institution><number>9</number><subtype>400</subtype><endpage>1231</endpage><bundle><publication><title>European journal of pain (London, England)</title><type>-100</type><subtype>-100</subtype><uuid>7E428D9E-4036-430E-83B3-46F7FAA4EB68</uuid></publication></bundle><authors><author><firstName>D</firstName><lastName>Champion</lastName></author><author><firstName>S</firstName><lastName>Pathirana</lastName></author><author><firstName>C</firstName><lastName>Flynn</lastName></author><author><firstName>A</firstName><lastName>Taylor</lastName></author><author><firstName>J</firstName><middleNames>L</middleNames><lastName>Hopper</lastName></author><author><firstName>S</firstName><middleNames>F</middleNames><lastName>Berkovic</lastName></author><author><firstName>T</firstName><lastName>Jaaniste</lastName></author><author><firstName>W</firstName><lastName>Qiu</lastName></author></authors></publication></publications><cites></cites></citation>(8).

The sampling of children for this study was based upon convenience, and must be considered as a possible limitation of external validity. In addition, the test-retest reliability trials were conducted on children whose RLS status was ill-defined, albeit to evaluate the repeatability of the questionnaire, rather than to assess the children. However, it must be acknowledged that parents of children with and without diagnosed RLS, may have responded differently.

Another paediatric RLS instrument has also been developed  ADDIN PAPERS2_CITATIONS <citation><uuid>195D23DB-DA5E-4479-B232-A0D133C18AC9</uuid><priority>0</priority><publications><publication><uuid>19D4B33E-2385-4D34-8FF7-378B54CF385B</uuid><volume>11</volume><accepted_date>99201003251200000000222000</accepted_date><doi>10.1016/j.sleep.2010.03.016</doi><startpage>897</startpage><revision_date>99201003191200000000222000</revision_date><publication_date>99201010001200000000220000</publication_date><url>http://linkinghub.elsevier.com/retrieve/pii/S1389945710002480</url><type>400</type><title>Development of the Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS): a patient-reported outcome measure of pediatric RLS symptoms and impact.</title><location>&lt;html&gt;&lt;head&gt;&lt;meta http-equiv="content-type" content="text/html; charset=utf-8"/&gt;&lt;title&gt;Sorry...&lt;/title&gt;&lt;style&gt; body { font-family: verdana, arial, sans-serif; background-color: #fff; color: #000; }&lt;/style&gt;&lt;/head&gt;&lt;body&gt;&lt;div&gt;&lt;table&gt;&lt;tr&gt;&lt;td&gt;&lt;b&gt;&lt;font face=times color=#0039b6 size=10&gt;G&lt;/font&gt;&lt;font face=times color=#c41200 size=10&gt;o&lt;/font&gt;&lt;font face=times color=#f3c518 size=10&gt;o&lt;/font&gt;&lt;font face=times color=#0039b6 size=10&gt;g&lt;/font&gt;&lt;font face=times color=#30a72f size=10&gt;l&lt;/font&gt;&lt;font face=times color=#c41200 size=10&gt;e&lt;/font&gt;&lt;/b&gt;&lt;/td&gt;&lt;td style="text-align: left; vertical-align: bottom; padding-bottom: 15px; width: 50%"&gt;&lt;div style="border-bottom: 1px solid #dfdfdf;"&gt;Sorry...&lt;/div&gt;&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;&lt;/div&gt;&lt;div style="margin-left: 4em;"&gt;&lt;h1&gt;We're sorry...&lt;/h1&gt;&lt;p&gt;... but your computer or network may be sending automated queries. To protect our users, we can't process your request right now.&lt;/p&gt;&lt;/div&gt;&lt;div style="margin-left: 4em;"&gt;See &lt;a href="https://support.google.com/websearch/answer/86640"&gt;Google Help&lt;/a&gt; for more information.&lt;br/&gt;&lt;br/&gt;&lt;/div&gt;&lt;div style="text-align: center; border-top: 1px solid #dfdfdf;"&gt;&amp;copy; 2013 Google - &lt;a href="https://www.google.com"&gt;Google Home&lt;/a&gt;&lt;/div&gt;&lt;/body&gt;&lt;/html&gt;</location><submission_date>99201001201200000000222000</submission_date><number>9</number><institution>Mapi Values Ltd., Cheshire, United Kingdom. rob.arbuckle@mapivalues.com</institution><subtype>400</subtype><endpage>906</endpage><bundle><publication><publisher>Elsevier B.V.</publisher><title>Sleep Medicine</title><type>-100</type><subtype>-100</subtype><uuid>973A01DF-FB9B-49AE-AC7D-47900119D7ED</uuid></publication></bundle><authors><author><firstName>Robert</firstName><lastName>Arbuckle</lastName></author><author><firstName>Linda</firstName><lastName>Abetz</lastName></author><author><firstName>Jeffrey</firstName><middleNames>S</middleNames><lastName>Durmer</lastName></author><author><firstName>Anna</firstName><lastName>Ivanenko</lastName></author><author><firstName>Judith</firstName><middleNames>A</middleNames><lastName>Owens</lastName></author><author><firstName>Jens</firstName><lastName>Croenlein</lastName></author><author><firstName>Kate</firstName><lastName>Bolton</lastName></author><author><firstName>Adam</firstName><lastName>Moore</lastName></author><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Arthur</firstName><middleNames>S</middleNames><lastName>Walters</lastName></author><author><firstName>Daniel</firstName><middleNames>L</middleNames><lastName>Picchietti</lastName></author></authors></publication></publications><cites></cites></citation>(17). The Pediatric Restless Legs Syndrome Severity Scale (P-RLS-SS) is a patient-reported outcome measure of pediatric RLS symptoms and impact. Similarly to the p-RLSQ, the P-RLS-SS was also constructed from input from children and adolescents with RLS, their parents, and clinical experts. The P-RLS-SS provides a scale that is intended to be comprehensive and clinically relevant. The P-RLS-SS is applicable for identified cases of RLS in children, but is yet to be validated.

Used in tandem, the p-RLSQ may be used to quickly filter cases of young children suspected to have RLS. Parent responses to the p-RLSQ could form a screening or triage mechanism, with positive responses then given the P-RLS-SS, which is more comprehensive and time-consuming to complete. The combination of the two tools may have capacity to better identify those children most likely to have RLS, which could better direct the resources used for both diagnosis and management. Further work is pending this possible clinical pathway.

RLS delays sleep onset and reduces total sleep time on an ongoing basis not only in childhood but also throughout adulthood or during particular life phases eg pregnancy. The wider health issues including insomnia, daytime somnolence, cardiovascular and neurological problems have been well documented ADDIN PAPERS2_CITATIONS <citation><uuid>C624C240-42F8-45DB-BD46-F0EB7A672DB2</uuid><priority>0</priority><publications><publication><volume>45</volume><publication_date>99200100001200000000200000</publication_date><number>2</number><institution>Department of Neurology, University Hospital (Inselspital), Bern, Switzerland. claudio.bassetti@insel.ch</institution><startpage>67</startpage><title>Restless legs syndrome: a clinical study of 55 patients.</title><uuid>7824E75D-3E88-4362-AD0D-A16E076D1CC4</uuid><subtype>400</subtype><endpage>74</endpage><type>400</type><url>http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=11244268&amp;retmode=ref&amp;cmd=prlinks</url><bundle><publication><title>European neurology</title><type>-100</type><subtype>-100</subtype><uuid>CD93440F-AE98-4B29-95C3-207C5F6A4092</uuid></publication></bundle><authors><author><firstName>C</firstName><middleNames>L</middleNames><lastName>Bassetti</lastName></author><author><firstName>D</firstName><lastName>Mauerhofer</lastName></author><author><firstName>M</firstName><lastName>Gugger</lastName></author><author><firstName>J</firstName><lastName>Mathis</lastName></author><author><firstName>C</firstName><middleNames>W</middleNames><lastName>Hess</lastName></author></authors></publication></publications><cites></cites></citation>(25). RLS, as with many sleep problems, remains largely under recognised and hence often untreated ADDIN PAPERS2_CITATIONS <citation><uuid>33AC720D-B2A3-457F-A6A5-2840CFBF714F</uuid><priority>0</priority><publications><publication><uuid>3EA17C53-80FA-493C-995C-CB6E33AC085A</uuid><volume>7</volume><doi>10.1007/s11325-003-0167-8</doi><startpage>167</startpage><publication_date>99200312001200000000220000</publication_date><url>http://link.springer.com/10.1007/s11325-003-0167-8</url><type>400</type><title>Symptoms of sleep breathing disorders in children are underreported by parents at general practice visits.</title><institution>Centre for Sleep Research, Queen Elizabeth Hospital, Woodville, South Australia. sblunden_sleepclinic@hotmail.com</institution><number>4</number><subtype>400</subtype><endpage>176</endpage><bundle><publication><title>Sleep &amp; breathing = Schlaf &amp; Atmung</title><type>-100</type><subtype>-100</subtype><uuid>482FCC69-C985-4A4D-96C2-24048C275F20</uuid></publication></bundle><authors><author><firstName>Sarah</firstName><lastName>Blunden</lastName></author><author><firstName>Kurt</firstName><lastName>Lushington</lastName></author><author><firstName>Berndt</firstName><lastName>Lorenzen</lastName></author><author><firstName>Johnny</firstName><lastName>Wong</lastName></author><author><firstName>R</firstName><lastName>Balendran</lastName></author><author><firstName>Declan</firstName><lastName>Kennedy</lastName></author></authors></publication></publications><cites></cites></citation>(26). Improved identification and rating of RLS through questionnaires such as the p-RLSQ and the P-RLS-SS, may assist in epidemiological studies that can increase our understanding of the prevalence of RLS in children and may lead to better treatment outcomes. 
Clinical studies have reported improved sleep patterns and daytime function following treatment ADDIN PAPERS2_CITATIONS <citation><uuid>CA3DC7A5-200E-4444-8CFC-AAD3FAC7D5BF</uuid><priority>0</priority><publications><publication><uuid>78941AD2-FDC4-4049-8B5F-7A2ADF0DC962</uuid><volume>22 Suppl 18</volume><doi>10.1002/mds.21588</doi><startpage>S485</startpage><publication_date>99200700001200000000200000</publication_date><url>http://doi.wiley.com/10.1002/mds.21588</url><type>400</type><title>Assessment of restless legs syndrome--methodological approaches for use in practice and clinical trials.</title><institution>IMEREM Institute for Medical Research Management, Biometrics Ltd., University of Erlangen-Nuremberg, Nuremberg, Germany. kohnen@imerem.de</institution><number>S18</number><subtype>400</subtype><endpage>94</endpage><bundle><publication><title>Movement disorders : official journal of the Movement Disorder Society</title><type>-100</type><subtype>-100</subtype><uuid>882CB70F-A76E-49E9-9CBD-60EA9C031C5E</uuid></publication></bundle><authors><author><firstName>Ralf</firstName><lastName>Kohnen</lastName></author><author><firstName>Richard</firstName><middleNames>P</middleNames><lastName>Allen</lastName></author><author><firstName>Heike</firstName><lastName>Benes</lastName></author><author><firstName>Diego</firstName><lastName>Garcia-Borreguero</lastName></author><author><firstName>Wayne</firstName><middleNames>A</middleNames><lastName>Hening</lastName></author><author><firstName>Karin</firstName><lastName>Stiasny-Kolster</lastName></author><author><firstName>Marco</firstName><lastName>Zucconi</lastName></author></authors></publication></publications><cites></cites></citation>(27). Contextually, a study of RLS in Australian children has not been undertaken, hence there is no clear indication of how many children suffering from this disorder are at risk of ongoing sleep difficulties or even developmental deficits and who would benefit from treatment. The availability of the p-RLSQ, makes possible the specific study of RLS in children.
The results of this study and the development of the resulting p-RLSQ instrument may enable children with RLS to be identified more easily, cost-effectively, subsequently investigated for RLS severity symptoms, and prevalence. Ultimately, children identified with RLS may be more specifically managed and better treatment methods instigated.		



 
Table 1

The transcripts of the interviews and focus group were assessed by two independent experts and yielded an average % agreement of 71% (range: 25 � 100%).


Theme

Expert 1
Expert 2

% agreement

Interview no: 1-6, Focus group: FG
constant movement of legs1, 2, 3, FG125time of day (later, night)1, 2, 4, 6, FG2, 4, 6, FG80pain, hurting, crying2, 3, 4, 5, 62, 3, 4, 5, 6100fidgety - awake and asleep 1, 3, 5, 63, 550messy bed33100wanting leg massage2, 3, 5333.3anxiety of child (about sleep problems)3, 5, 63, 5, 6100oppositional behaviour re going to bed44100sleeplessness, waking1, 2, 3, 5, 6, FG5, FG33.3family pattern of RLS2, 4, 5, 6625sleepy, tired, annoyed, grumpy during dayFGFG100effect on parents (co-sleeping)3, 4, 6433.3


Table 2
The non-parametric correlations of question reliability from Trial 1. The average correlation (rho) was 0.556 (range 0.00 � 1.00). Questions 5 and 6 were subsequently eliminated for Trial 2.

Qu
Question
Part questions
Spearman�s rho
n=19
1Restless legs?0.818**2Growing pains?0.335n=11
3experienceHurt at night-0.100Wakes0.828**Cries0.810**Has to move legs0.833**Bed is messy0.833**4How often?Daily1.00**Weekly-0.100Monthly-0.2893 monthly0.770**6 monthly0.624*5Treatment or investigationsNone0.149Pain medication0.3896Family history?0.0697Parent actionRubbed legs1.000**paracetamol0.2418AssociationsAfter sport0.607*Increased activity0.571Poor sleep0.671*Fidgety, restless0.241Anxious0Sleepy, grumpy, tired0.624*Funny feelings in legs eg fizzy1.000**9Happy to go to bed?0.671*10Does child sleep well?0.857**11Child�s RLS affect parent sleep?0.670*12QoL5-pt Likert scale0.592n=19
13ager = 0.967**sex1.000**

* p<0.05,  ** p<0.01

Table 3

Trial 2, the reliability study, yielded 40 (12.4%) repeated responses from 322 distributed questionnaires across three schools, from the parents of children aged eight to nine years.

School 1School 2School 3N = 40N = 112N = 170
No. questionnaires distributed
322 (100%)
Total Round 1 responses 57 (17.7 %)62031
Total repeated responses 40 (70.1 %)31423


Table 4


The reliability results from Trial 2 returned an average ICC = 0.748. Fourteen of the 21 part-questions yielded ICC > 0.75, further indicating good reliability of the developed instrument.

QuestionICC95% CIICC > 0.75
1. RLS0.770.57 � 0.88*2. Growing pains0.910.82 � 0.95*3. Wakes0.730.33 � 0.89    Cries0.800.50 � 0.92*    Moves legs0.660.16 � 0.86    Bed messy0.790.48 � 0.92*4. Daily-    Weekly0.750.38 � 0.90*    Monthly0.830.57 � 0.93*    Tri monthly0.850.62 � 0.94*5. Rubbed legs0.860.65 � 0.94*6. After sport0.56-0.91 � 0.82    Increased activity0.51-0.23 � 0.80    Poor sleep0.870.69 � 0.95*    Fidgety 0.730.32 � 0.89    Grumpy0.800.49 � 0.92*    Funny feelings0.700.24 � 0.887. Happy to go to bed-8. Sleeps well0.670.18 � 0.879. Effects sleep0.850.73 � 0.92*10. QoL0.870.74 � 0.93*11. Age0.960.93 � 0.98*     Sex1.000.00*
Summary questions from IRLSG criteria1 urge to move0.600.25 � 0.792 motor restlessness0.38-0.17 � 0.673 worse with rest0.530.12 � 0.754 worse at night0.730.49 � 0.85
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