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. 2015 Jun 30;50(5):676–718. doi: 10.1111/1460-6984.12171
1. Selection bias: method used to generate the allocation sequence, method used to conceal the allocation sequence. Presence of control, characteristics of participants at baseline, ± 10 sample 2. Performance bias: measures used to blind participants and personnel and outcome assessors, presence of other potential threats to validity. Collection and assessment of speech sample 3. Attrition bias: incomplete outcome data, high level of withdrawals from the study. High dropout rate (above 15%) 4. Detection bias: accuracy of measurement of outcomes, length of follow‐up. Reliable tool used, adequate speech sample, outside laboratory recording, immediate versus longer‐term follow‐up 5. Reporting bias: selective reporting, accuracy of reporting. Use of inferential versus descriptive statistics, pooled or individual reporting Overall risk of bias. Lower/higher Detail of concerns
Risk of bias: yes/no/unclear
Allen, 2011 Yes Yes No Yes Yes Higher Small sample, unclear research questions and recruitment justification, poor reporting
Amster and Klein, 2008 Yes Yes No Yes No Higher Small sample, no control, volunteered sample
Andrews et al., 2012 Yes Yes Yes No No Higher Small sample, no control, volunteered sample
Antipova et al., 2008 Yes Yes No Yes No Higher Small sample, no control, volunteered sample
Armson and Stuart, 1998 Yes Yes No Yes No Higher Small sample, experimental design with no follow‐up (FU). Single session tests, Kappa scoring methods not described or reliability/results in detail
Armson et al., 2006 Yes Yes No Yes No Higher Small sample, experimental design with no FU
Armson and Kiefte, 2008 Yes Yes No Yes No Higher Mid‐sized sample experimental design with no FU. First 31 people taken into study
Baumeister et al., 2003 Yes Yes Yes No No Higher Large sample, but no control group. Participants showed different severity of disorder which influenced results. Some participants dropped out or were not assessed at baseline
Beilby et al., 2012 No Unclear No No No Lower Unclear if raters were blinded to time point, 3‐month FU
Berkowitz et al., 1994 Yes Yes No No No Higher Very small sample, no control, no blinding in assessment, self‐reports used
Block et al., 2004 No No No Yes Yes Higher Sample 12, 5‐min conversation 5‐min reading. Unclear who recorded away from clinic. Basic results for post‐treatment periods, 3‐month FU, limited analysis
Block et al., 2005 No No No No No Lower Large sample, self‐report inventory used at 35‐year FU with 87% of sample response rate. Unclear length of speech sample
Block et al., 2006 No No No No No Lower Same study as 2005 paper with further examination of variables
Block et al., 1996 No No No Yes No Higher Larger sample, no dropout, immediate measurement during intervention, experimental setting, 5‐min samples
Blomgren et al., 2005 Yes Unclear No No No Lower Sample 19. Some use of self‐reported outcome measures post‐study. Sample 4 min of speech, unclear if rater blinded, 6‐month FU
Blood, 1995 Yes Yes No Yes Yes Higher Extremely small sample. Flawed recruitment. Use of self‐reported outcomes
Boberg and Kully, 1994 No Unclear No Yes Yes Higher Sample 42, no control. Telephone call sample 2 min. Unclear if raters blind to time point, percentage change reported
Bonelli et al., 2000 Yes No No No Yes Higher Sample of 9 selected from earlier study, no pooling of data reported by individual only
Bray and James, 2009 Yes Yes No Yes Yes Higher Small sample, use of self‐reported outcomes
Bray and Kehle, 1998 Yes Yes No Yes Yes Higher Small sample (4), volunteers. Content of speech sample and listener varied between individuals and time, descriptive data by individual only
Carey et al., 2010 No No No No No Lower 20 per trial arm, with 75% loss to FU, 12‐month FU, 10‐min recording via telephone, blinded assessment
Cocomazzo et al., 2012 No No Yes Unclear No Lower 12 participants and dropouts, blinded rating, beyond clinic recordings made by participant but asked to make only one, 12‐month FU
Craig et al., 1996 No No No Yes No Lower Larger sample, raters blinded 12‐month FU, 5‐min speech samples
Craig et al., 2002 Yes Yes No Yes No Higher Small sample (6) selected from previous study, 2‐year FU, descriptive data for individuals only, home measure potential for bias
Cream et al., 2009 Yes No Yes Yes No Higher Sample of 10, 5‐min recordings, use of some self‐reported outcomes, 2 dropouts in small sample, blinded assessor, immediate post‐assessment
Cream et al., 2010 No No No No No Lower Randomized sample with acceptable dropout rate, blinded assessment, 6‐month FU
De Veer et al., 2009 Yes Yes No Yes No Higher Selection of potential participants by researchers. No detail of randomization. No measure of fluency, self‐report measures only
Druce et al., 1997 Yes No No Yes No Lower Sample 15 with adequate FU, 2‐min speech sample, raters blinded
Elliott et al., 1998 Yes Yes No No Yes Higher Small sample (5) 5‐min conversation sample, reported by individuals, limited analysis
Femrell et al., 2012 Yes Yes Yes Yes No Higher Sample 10 with 2 loss to FU, 10‐min conversation, assessed by clinician, not blinded
Foundas et al., 2013 No Unclear No Unclear No Higher Sample 24 (10 control) with control and experimental conditions. Immediate outcomes, length of sample not reported. Unclear whether blinded
Franken et al., 1992 No No No Yes No Higher Fair sized sample, (32) 6‐month FU, rating scale used, blinded assessment, control normal speakers, 5‐min recordings, purpose to compare normal to post‐intervention rather than evaluate interventions per se
Franken et al., 2005 No No Yes Yes No Lower Small sample randomized to 1 of 2 arms. Loss to FU, recordings made by parents, blinded assessors
Franklin et al., 2008 No Yes No Unclear No Higher Larger sample, however, participants were not randomized to each condition, assessment carried out by authors not blinded, immediate FU, sample 1500 syllables
Gagnon and Ladouceur, 1992 Yes Unclear No Unclear Yes Higher Small samples used in separate studies. Data presented by individual, lack of clarity regarding data collection and evaluation
Gallop and Runyan, 2012 Yes Unclear Unclear Yes Yes Higher Sample 11 participants no control, no explanation of recruitment criteria, 15‐min telephone samples, not reported if blinded, informal FU
Hancock and Craig, 1998 Yes No No No No Lower Larger sample (77 participants), 12‐month FU. Pseudo‐randomization, 5‐min speech sample, in clinic at distance via phone
Hancock et al., 1998 Yes No No No No Lower Same study as other paper. This paper reports some different outcomes
Hancock and Craig, 2002 Yes No No Yes No Lower Sample (12) selected from earlier study 5‐min only speech sample
Harris et al., 2002 No No Yes No No Lower Small study 29 participants, 6 dropped out (21%)
Harrison et al., 2004 No No Yes No No Lower 46 participants, 8 dropped out
Hasbrouck, 1992 Unclear Yes No No Unclear Higher Larger sample, no control, no blinding. Very sparse details given about recruitment, attrition, analysis
Hewat et al., 2006 No No Yes Yes No Lower 30 participants recruited, dropout varied from 27% to 40% at different stages of the study, in clinic recording and participant selected recording, rating blinded
Hudock and Kalinowski, 2014 Unclear No No Yes Yes Higher Small study (9) no detail of recruitment, scripted telephone conversations, immediate measurement
Huinck et al., 2006 Unclear No No No No Lower 25 participants. No details given about recruitment methods
Ingham et al., 2013 Yes Unclear Yes Yes No Higher Volunteer participants, 9 of 21 did not complete 3‐min monologue, 3‐min conversation. Study purpose to compare normal to PWS however contains before and after data. No detail of whether raters blinded, immediate FU, in‐clinic rating
Ingham et al., 2001 Yes No No Yes No Higher Small sample (5 participants). Use of some self‐reported measures, participants submitted own recording for beyond clinic measure, not detailed whether raters blinded, data reported by participant
Irani et al., 2012 No Unclear No Yes No Higher Mixed method study some self reported measures, use of inferential statistics, small sample (7) little detail of speech sample analysis
Iverach et al., 2009 No No No Yes No Lower Larger sample (64 participants). Use of some self‐reported measures
Jones et al., 2000 No No No No No Lower Large sample (261 children, 4% dropout rate, all explained)
Jones et al., 2005 No No No No No Lower Larger sample (54 children, 13% dropout rate, all explained)
Jones et al., 2008 No No Yes No No Lower This is a 5‐year FU of the earlier study 31% of the original treatment group could not be re‐contacted, and 68% of the control group
Kaya and Alladin, 2012 Yes No No Yes No Higher No comparator group. No detail regarding how stuttering occurrences defined. Immediate assessment at final session
Kaya, 2011 Yes Yes No Yes No Higher Assessment via 2‐min speech sample only, rating scale measure used very limited
Kingston et al., 2003 No Yes No Yes No Higher Larger sample (78 children). Assessment was done by the clinician/researcher with no blinding. Purpose of paper to examine associations (predict treatment time) rather than outcomes
Koushik et al., 2009 No No No No Yes Lower Sample 12 children, 1 dropped out
Koushik et al., 2011 Unclear Unclear No Unclear No Higher Pooled data from 5 clinical sites. Larger sample (134 participants in final analysis). Retrospective file audit. Purpose of study to examine associations rather than evaluate outcomes
Laiho and Klippi, 2007 No Yes No Yes No Higher Sample 21, no control, assessment via video by author, parent‐report data for beyond clinic data. Follow‐up data only parent report
Langevin and Boberg, 1993 Yes No Yes No No Higher Small sample, high dropout rate (21 participants, 11 dropped out) data reported by individual
Langevin and Boberg, 1996 Yes No Yes No No Lower 25 in 1 group, 16 in other. Two‐year FU, some loss to FU 2/3‐min samples of speech in clinic and via telephone. Raters probably blinded
Langevin et al., 2006 No No No No No Lower 18 participants, no control. Small loss to FU
Langevin et al., 2010 Yes No Yes No No Lower 5‐year FU of earlier study
Lattermann et al., 2008 No No No No No Lower Sample 46, blinded rating
Lawson et al., 1993 No No No Yes No Higher Self‐report measures only used, 1‐month FU, some dropout
Leahy and Collins, 1991 Yes Yes No Yes Yes Higher No comparator group, small sample size n = 5 Measures taken by student clinician carrying out intervention. Longer FU only for 2. Reporting by individual only
Lewis et al., 2008 No No No No No Lower Small sample (8 in intervention group, 10 in control group)
Lincoln et al., 1996 No No No Yes Yes Higher Sample of 11, high dropout of potential participants (22 recruited). Some pooled data, some reporting of individuals only, 12‐month FU, parent‐recorded speech data
Lincoln and Onslow, 1997 No Yes Yes Yes Yes Higher Long‐term outcomes of earlier studies. Large initial dropout of potential participants. Parents collected speech sample, parent report questionnaire, descriptive data
Lutz, 2009 Yes Yes No Yes No Higher Findings from a workshop for parents using before and after questionnaires
Mallard, 1998 No Yes No Yes Yes Higher Only measure of success was ‘is child in S&L therapy 1 year after intervention?’ No control group, limited analysis
Menzies et al., 2008 No No No No No Lower Smaller sample—32 participants, 2 dropped out, 16 in each condition
Millard et al., 2008 No No Yes No No Higher Small sample (9) high dropout rate (30%), blinded rating, in clinic assessment, 12‐month FU, data by individual only
Millard et al., 2009 No No Yes No Yes Higher Small sample (10) high dropout rate, parent‐recorded video data. Control group for initial allocation but removed part way, no pooled data descriptive statistics only
Miller and Guitar, 2009 No No No No No Lower Long‐term FU, many participants at minimum level Only 2 dropouts from 15, limited speech sample
Nilsen and Ramberg, 1999 No No No Yes No Higher 2 dropouts from 13, use of some scales with limited scoring and analysis, data reported by individual
O'Brian et al., 2003 No No No Yes Yes Higher 5 dropout from 30. Reasonable sample, no comparator, participant‐selected recordings, limited statistical analysis
O'Brian et al., 2008 No No Yes No Yes Higher 16 of 30 completed. Descriptive analysis
O'Brian et al., 2013 No No No No No Lower No control
O'Donnell et al., 2008 Yes No No No Yes Higher Small sample (7), 5 from previous study who had shown most benefit. Data reported by individual participant
Onslow et al., 1994 Unclear No Yes Yes No Higher High withdrawal for control and intervention, no detail of allocation, audio recordings made by parents, descriptive statistics
Onslow et al., 1990 Yes Yes No No Yes Higher No comparator group, sample size n = 4. Presentation of findings via figures only, no grouping of data
Onslow et al., 1992 Unclear No No No No Higher Focuses on speech naturalness data only comparing PWS and non‐stutterers, no control group, immediate FU, recruitment process unclear
Onslow et al., 1996 Unclear No Yes No No Higher Data reported for only 18 of 32 recruited
Onslow et al., 2002 Yes No No No Yes Higher Small sample (8) 6 of whom in previous studies. For 2 parent‐only recordings. Descriptive data presented by individual only. Purpose of paper to evaluate 1 aspect of intervention outcome
Pape‐Neumann, 2004 Yes Yes Yes Yes Yes Higher This is a pilot study which presents data from a range of interventions
Pollard et al., 2009 No Yes No Yes No Lower Sample 11, no dropout, samples collected at non‐laboratory locations, non‐blinded scoring, immediate outcomes
Ratynska et al., 2012 Yes Yes No Unclear No Higher Large sample found other treatment ineffective, no dropout, no blinding of assessment, incomplete description of data collection
Reddy et al., 2010 Unclear Unclear No Unclear Unclear Higher Small sample (5), limited reporting of findings beyond description of cases
Riley and Ingham, 2000 Unclear Unclear No Unclear Yes Higher Sample 12, pseudo‐randomization, no blinding of assessors, unclear beyond clinic data collection, unclear whether 12 or 6 participants being reported, no reporting of control group outcomes
Rosenberger, 2007 Yes Yes Yes No No Higher Two groups were compared which have an uneven number of participants. Some dropout. Limited blinding and speech measures
Rousseau et al., 2007 No Yes No No No Lower Reasonable sample large proportion of parent‐recorded samples, no analysis of dropouts
Ryan and Van Kirk, 1995 No Yes Yes No No Lower Reasonable sample (24, 20 completed all elements). Pseudo‐randomization, no blinding of speech evaluation
Sicotte et al., 2003 Yes Yes No Yes No Higher Sample 6, rating scales only. Purpose of study to evaluate intervention fidelity rather than outcomes
Smits‐Bandstra and Yovetitch, 2003 Yes Unclear No Yes No Higher Small groups. Each time point presented separately in table form, limited discussion of trends over time. Six participants had received other intervention immediately prior 3‐min sample, assume no blinding, limited statistical analysis
Stewart, 1996 No Yes No Yes No Higher Reasonable sample (15) no blinding of assessment, 3‐min conversation, limited analysis of speech behaviour data, no outside clinic measure, reasonable FU
Stidham et al., 2006 Yes Yes No No No Higher Volunteers recruited, small sample (9), immediate FU, no blinding as assessment, in laboratory evaluation
Stuart et al., 2004 Unclear Yes No No No Higher No detail of recruitment, non‐blinded assessment, in laboratory evaluation, limited speech sample
Stuart et al., 2006 Unclear Yes (for some elements) No Yes No Higher No detail of recruitment, no blinding of assessment for first studies, limited speech sample (300 syllables), reasonable FU, in clinic assessment
Trajkovski et al., 2011 No No Yes Yes No Lower 8 of 17 completed, data provided for dropouts, limited pooled data, parent‐collected recordings
Unger, 2012 Yes Yes No Yes No Higher Volunteer participants, reasonable sample, in clinic only, immediate FU, no blinding of assessment 2 × 5‐min monologues
Van Borsel, 2003 Yes Yes No No No Higher Volunteer participants, in‐clinic data, no blinding of recordings, small sample (9)
Von Gudenberg, 2006 Yes Yes Yes Yes Yes Higher No clear description of any measurement, participants or methods used; more a evaluation of collected data up to now
Von Gudenberg et al., 2006 Yes Yes Yes Yes Yes Higher Detailed description of the therapy reasons why this therapy may be effective and a good approach for young adults. However, presented results are outcomes with no clear description of methodology and limited analysis
Wagaman et al., 1993 Yes No No No No Lower Follow‐up data from study
Wagaman et al., 1995 Yes No No Yes No Higher Small sample; no long‐term FU
Ward, 1992 Yes Yes No Unclear No Higher No long‐term outcomes. Reports pilot study findings only, small sample
Wille, 1999 Yes Yes Yes Yes Yes Higher No clear description of method, data collection, data analyses; no reference to other literature
Wilson et al., 2004 No Yes Yes No Yes Higher Small sample, dropouts and lack of data
Woods et al., 2002 Yes No No No No Lower Small sample (8), 1‐month FU. No speech data, study focuses on cognitive and language assessments
Yairi and Ambrose, 1992 No Unclear Yes No No Higher Reasonable sample (27) 2‐year FU, speech sample small (around 500 words), 6 dropout, unclear whether speech assessors blinded, in clinic data
Yaruss et al., 2006 No Yes No Yes No Higher Sample 17, speech rated by clinician, FU up to 2 years with no dropout, at least 200 word sample unclear how collected, limited analysis
Zimmerman et al., 1997 No Unclear No Yes No Higher Small sample (9), no long‐term FU, scripted conversations, unclear if rater blinded