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Table 4 Quality rating of randomized controlled trials

From: Manual therapy for the pediatric population: a systematic review

Author/year Condition sample size (n) Results summary Intervention Selection bias: random Selection bias: allocation Performance bias: blinding of personnel and participants Detection bias:
blinding of outcome assessment
Attrition bias:
incomplete outcome data
Reporting bias:
selective reporting
Other bias: anything else, ideally pre-specified Overall quality rating
Gastrointestinal/Urinary
 Miller J, et al. 2012 [19] Infantile Colic (n = 104) Improvement CMT L computer generated permutated blocks L sealed in sequentially numbered opaque envelopes L envelopes revealed to treating provider before treatment, 1 of 3 groups parents knew infants were being treated U-PY two of three groups of parents blinded to treatment, data extractor blinded to teratment H per protocol analysis conducted L all outcomes reported U-PN “parent diagnosis”, selective nature of diary High
 Browning M & Miller J, 2008 [21] Infantile Colic (n = 43) No difference CMT L computer generated H not stated L blinding of both parents and patients L independent observer binded to treatment L all outcomes reported L all outcomes reported H strict inclusion criteria, small study size, inexperienced iterns High
 Hayden C & Mullinger B, 2006 [23] Infantile Colic (n = 28) Improvement OMT/CST L random number table U-PY random table number utilized but not discussed H patients and providers not blinded H outcome assessors unblinded H 2 withdrew and not included in analysis L all outcomes reported U-PN small study size, lack of standardized treatment Medium
 Olafsdottir E, et al. 2001 [22] Infantile Colic (n = 86) No difference CMT H “randomized” not described U-PY “sealed” envelopes L parents and providers blinded L outcome assessor blinded L intention to treat analysis L all outcomes reported U-PY small sample size High
Musculoskeletal
 Nemett D, et al. 2008 [24] Pediatric Dysfunctional Voiding (n = 21) Improvement OMT U-PY stated “randomized assigned” with no further description H nothing stated H nothing stated H only primary outcome assessor blinded H per protocol analysis conducted L all expected outcomes reported, secondary outcome not initially evaluated in control group per protocol L study appears free of other sources of bias Medium
 Nilgun B, et al. 2011 [28] Idiopathic Clubfoot (n = 29) Improvement MT H randomized by travel and physical abilities H not concealed H parents, patients, therapists not blinded H outcome assessor not blinded L all outcomes reported L all outcomes reported H pilot study only Low
 Borusiak P, et al. 2010 [31] Cervicogenic HA (n = 52) No difference MT L computer generated L sequentially numbered identical opaque envelopes L parents, patients and pediatrician blinded U-PY pre-established analysis plan not described H per protocol analysis conducted L all outcomes reported H small sample size, clinical effect of sham, observational bias Medium
 Evans R, et al. 2018 [33] Subacute and Chronic LBP (n = 185) Improvement CMT L computerized dynamic allocation (rank-order minization) system L sealed in sequentially numbered opaque envelopes H patients and providers not blinded L outcome assessor blinded L all outcomes reported L all outcomes reported L study appears free of other sources of bias High
 Selhorst M & Selhorst B, 2015 [35] Mechanical LBP (n = 35) No difference MT H not described H not described U-PY blinding of patients, exercise therapist, no blinding of manual therapist L all outcomes patient self-report blinded H per protocol anaylsis conducted L all outcomes reported L study appear to be free of other sources of bias Medium
 Garcia-Mata S & Hidalgo-Ovejero A, 2014 [37] Pulled Elbow (n = 115) Improvement MT H not described H not described H parents, patients, therapists not blinded H outcome assessors not blinded L all expected outcomes reported L all outcomes reported L study appear to be free of other sources o bias Medium
 Bek B, et al. 2009 [38] Pulled Elbow (n = 66) Improvement MT H not described H not described H no blinding H outcome assessors not blinded L intention to treat analysis L all outcomes reported L study appears free of other source of bias Medium
 Monaco A, et al. 2008 [39] Non-Specific Temporomandibular Disorder (n = 28) Improvement OMT H not described H not described H patients and providers not blinded H outcome assessor not blinded H follow up of participants were not discussed U-PN sample response for each outcome not provided U-PN small study size Low
Respiratory
 Guiney P, et al. 2005 [40] Asthma (n = 140) Improvement OMT U-PY not well described “randomization based on a 2:1 ratio” H not described H provider not blinded H outcome assessor not blinded L all patients accounted for L all outcomes reported L study appears free of other sources of bias Medium
 Bronfort G et al. 2001 [41] Asthma (n = 34) No improvement CMT L computer generated L sealed in opaque envelopes L blinding of both parents and patients L outcome assessor blinded L all patients accounted for L all outcomes reported L study appears free of other sources of bias High
 Vandenplas YDE, et al. 2008 [42] Obstructive Apnea (n = 34) Improvement OMT H not described H not described L patients blinded L outcome assessors blinded H per protocol analysis, 6 participants dropped out and not included in analysis L all outcomes reported U-PN small study size, imbalance in sizes of control to study Medium
 Steele D, et al. 2014 [43] Otitis Media (n = 34) Improvement OMT L study used “Research Randomizer” U-PY randomized tables generated with unique number assignment H providers not blinded, parents blinded but in treatment room L outcome assessors blinded L all patients accounted for L all outcomes reported H small sample size, pilot study Medium
 Wahl R, et al. 2008 [44] Otitis Media (n = 90) No difference OMT L randomization in blockes of 8 using random number table L 2 by2 factorial design L patients, parents, providers blinded L outcome assessor blinded L all patients accounted for L all outcomes reported U-PN unequal distribution of risk factors in treatment group High
 Mills M, et al. 2003 [47] Acute Otitis Media (n = 57) Improvement OMT L computer generated L independent nurse monitored and disclosed by phone H parents and provider not blinded L outcome assessor blinded H per protocol analysis, 19 dropped out and not included in analysis L all outcomes reported L study appears free of other sources of bias High
Special Needs
 Accorsi A, et al. 2014 [48] Attention-Deficit/Hyperactivity Disorder (n = 28) Improvement OMT L permuted-block ratio 1:1 using R statistical program U- PN allocation was concealed but not described U -PY patients/parents/providers not blinded but were blinded as to outcomes L outcome assessors blinded L all patients accounted for U -PN adverse events were being collected but not reported U-PN sample size not justified High
 Khorshid KA, et al. 2006 [50] Autism (n = 14) Improvement CMT H not described H not described H patients and providers not blinded H outcome assessors not blinded U-PN enrollment number not discussed L all outcomes reported U-PN sample size not justified Low
 Wyatt K, et al. 2011 [51] Cerebral Palsy (n = 142) No improvement OMT L telephone based randomization by independent statistician at remote site L allocation provided by independent statistician at remote site H parents and patients not blinded L outcome assessors blinded L all patients accounted for L all outcomes reported U-PN sample size not justified High
 Duncan B, et al. 2008 [53] Cerebral Palsy (n = 55) Improvement OMT L draw technique using stratification L blinding of concealment H parents, patients, providers not blinded L outcome assessor blinded H per protocol analysis conducted L all outcomes reported L study appears free of other sources of bias High
 Duncan B, et al. 2004 [52] Cerebral Palsy (n = 50) Improvement OMT H not described H not described H not described H outcome assessors not discussed H per protocol analysis conducted L all outcomes reported L study appears free of other sources of bias Low
 Raith W, et al. 2016 [54] Prematurity (n = 30) No difference OMT/CST L randomized using block design with block size 6 L sequentially sealed opaque envelopes L parents and providers blinded L outcome assessors blinded L all patients accounted for L all outcomes reported L study appears free of other sources of bias HIgh
 Cerritelli F, et al. 2015 [55] Prematurity (n = 695) Improvement OMT/CST L randomized using block design with block size 10 L performed in coordinating center U-PN providers not blinded L NICU staff blinded H per protocol analysis performed L all outcomes reported L study appears free of other sources of bias High
 Pizzolorusso G, et al. 2014 [56] Prematurity (n = 110) Improvement OMT/CST L computer generated permuted block L randomized by IT consultant U-PN providers not blinded L outcome assessors blinded L all patients accounted for L all outcomes reported L study appears free of other sources of bias High
 Cerritelli F, et al. 2013 [57] Prematurity (n = 110) Improvement OMT/CST L computer generated permuted block L random allocation by independent consultant H parents, patients, providers not blinded L outcome assessor blinded H per protocol analysis conducted L all outcomes reported L study appears free of other sources of bias High
Structural
 Cabrera-Martos I, et al. 2016 [58] Cranial Asymmetry (nonsynostotic plagiocephaly) (n = 46) Improvement MT/CST L randomized number generator in blocks of 4 L sealed envelope H patients and providers not blinded L outcome assessors blinded L all outcomes accounted for L all outcomes reported L study appears free of other sources of bias High
 Philippi H, et al. 2006 [60] Postural Asymmetry (n = 32) Improvement OMT/CST L block randomization L sealed in sequentially numbered envelopes L parents, patients, provider blinded L outcome assessor blinded L all outcomes accounted for L all outcomes reported L study appears free of other sources of bias High
 Hasler C, et al. 2010 [65] Scoliosis (n = 20) No improvement OMT L block randomization U-PY consealed envelopes H patients and provider not blinded L outcome assessor blinded L all outcomes accounted for L all outcomes reported U-PN small sample size High
 Rowe DE, et al. 2006 [62] Scoliosis (n = 6) No difference CMT L computer generated L independent personnel provided allocation assignent via e-mail L patients and provider blinded L outcome assessors blinded L all outcomes accounted for L all outcomes reported U-PN small sample size High
 Haugen E, et al. 2011 [66] Torticollis (n = 32) No difference MT H not described U-PY selaed envelope U-PN patients blinded, providers not blinded L outcome assessor blinded U-PN patient description and enrollment not discussed H not all outcomes reported U-PN sample size not justified Medium
  1. Legend: H-High risk of bias; L-Low risk of bias; NA-Not applicable; U-Unclear; PN-Probably No (high risk of bias); PY-Probably Yes (low risk of bias).
  2. Interventions: CMT Chiropractic Manipulative Therapy, CST Craniosacral Therapy, MT Manual Therapy, OMT Osteopathic Manipulative Therapy.