Table 4.
Quality rating of randomized controlled trials
| 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 |
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).
Interventions: CMT Chiropractic Manipulative Therapy, CST Craniosacral Therapy, MT Manual Therapy, OMT Osteopathic Manipulative Therapy.