Appendix Table E3Reporting characteristics in systematic reviews of implantable medical devices by study types

Reporting ItemRandomized trials
N=66
Systematic reviews
n (%)

Nonrandomized/observational studies
N=51
Both
N=64
P-value
Search
Search terms were described or referred to elsewhere58 (88)48 (94)59 (92)0.59
Multiple databases were searched57 (86)32 (63)55 (86)0.005
Years searched were described60 (91)44 (86)58 (90)0.76
Multiple languages were included in search31 (47)11 (22)20 (31)0.01
Authors explicitly stated searching for unpublished data43 (65)15 (29)22 (34)<0.001
Selection
Inclusion or exclusion criteria were stated63 (96)50 (98)62 (97)0.79
Population at baseline was reported66 (100)51 (100)64 (100)NA
Interventions/exposures were described66 (100)51 (100)64 (100)NA
Comparators were described66 (100)49 (96)64 (99)0.20
Outcomes were described66 (100)51 (100)64 (100)NA
Number of studies included and excluded were reported44 (66)31 (61)41 (61)0.53
Reasons for exclusion were described48 (73)39 (77)52 (80)0.61
Results
A flow diagram for the number of studies included and excluded was used31 (47)18 (35)31 (48)0.36
The number of primary studies included96212882038NA
Results were presented graphically58 (88)21 (41)38 (58)<0.001
Costs or cost-effectiveness were described17 (26)6 (12)19 (29)0.06
Meta-analyses were performed59 (89)23 (45)42 (64)<0.001
Device-specific Variables
Data on differences across device characteristics were discussed29 (44)23 (45)34 (55)0.60
Data on differences within device characteristics were discussed32 (48)11 (22)22 (34)0.01
Evolution of devices over time were discussed12 (18)11 (22)15 (23)0.76
Operator-specific Variables
Details of training/certification of provider were reported1 (2)0 (0)1 (2)1.0
Ramp-up in provider technique (i.e. learning curve) was discussed3 (5)6 (12)4 (6)0.31
Level of expertise of team/site were considered3 (5)7 (14)6 (9)0.20
Practitioner variability were discussed6 (9)6 (12)6 (9)0.86
“Volume at sites” effect were discussed2 (3)6 (12)6 (9)0.15
Handling of heterogeneity
Models for meta-analyses were reported59 (89)23 (45)42 (64)<0.001
Meta-analyses used accepted methodologies (e.g. studies grouped by design)59 (89)20 (39)36 (56)<0.001
Heterogeneity was assessed or discussed?42 (63)24 (47)37 (57)0.20
Sensitivity analyses were assessed32 (48)10 (20)23 (35)0.005
Results by subgroups were considered or quantified19 (29)8 (16)13 (20)0.22
Validity
Risk of bias was assessed39 (59)15 (29)25 (36)0.003
Publication bias was assessed34 (52)8 (16)17 (26)<0.001
Quality items or checklists were applied and reported33 (50)12 (23)27 (42)0.01
Discussion
Study limitations were described63 (96)50 (98)62 (97)0.79
Overall strength of the body of evidence was assessed10 (15)10 (19)13 (20)0.79
Specific future research recommendations were made48 (73)47 (92)54 (84)0.03
Funding source was declared33 (50)22 (43)21 (32)0.12
 Authors' affiliation to industry was reported16 (24)8 (16)14 (22)0.55

From: Appendix E, Tables 1–4 Subgroup Analyses

Cover of Quality of Reporting in Systematic Reviews of Implantable Medical Devices
Quality of Reporting in Systematic Reviews of Implantable Medical Devices [Internet].
Raman G, Gaylor JM, Rao M, et al.

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