Background
Methods
Search strategy
Data extraction
1. | Was the randomization method to groups appropriate? |
2. | Was the allocation sequence concealed from those assigning patients to groups? |
3. | Were the participants blind to the intervention? |
4. | Were the outcome assessors (for the primary outcome) blind to the intervention? |
5. | Was the outcome measurement performed in the same manner with similar intensity in the groups being compared? |
6. | Were similarly trained individuals administering the intervention across groups? |
7. | Were all the withdrawals described? |
8. | Were all originally randomized participants analyzed in the groups they were assigned to (i.e., an intention-to-treat analysis)? |
9. | Was clustering at the group level accounted for in the analyses? |
10. | Were the groups similar at baseline? |
Statistical analysis
Methodological quality criteria | Journal* | Yes | No | Not reported |
---|---|---|---|---|
Proper Methods of Randomization | AJSM | 70.3% | 9.5% | 20.3% |
JBJS | 74.5% | 6.6% | 18.9% | |
JOR | 57.1% | 0.0% | 42.9% | |
OC | 58.3% | 8.3% | 33.3% | |
SJ | 56.3% | 0.0% | 43.8% | |
Mean
| 63.3% | 4.9% | 31.8% | |
Concealment of Subject Allocation | AJSM | 66.2% | 8.1% | 25.7% |
JBJS | 75.5% | 6.6% | 17.9% | |
JOR | 57.1% | 0.0% | 42.9% | |
OC | 61.1% | 5.6% | 33.3% | |
SJ | 56.3% | 0.0% | 43.8% | |
Mean
| 63.2% | 4.1% | 32.7% | |
Blinding of Participants | AJSM | 14.9% | 18.9% | 66.2% |
JBJS | 20.8% | 23.6% | 55.7% | |
JOR | 14.3% | 0.0% | 85.7% | |
OC | 30.6% | 16.7% | 52.8% | |
SJ | 25.0% | 37.5% | 37.5% | |
Mean
| 21.1% | 19.3% | 59.6% | |
Blinding of Outcome Assessor | AJSM | 51.4% | 14.9% | 33.8% |
JBJS | 45.3% | 21.7% | 33.0% | |
JOR | 57.1% | 0.0% | 42.9% | |
OC | 61.1% | 2.8% | 36.1% | |
SJ | 37.5% | 18.8% | 43.8% | |
Mean
| 50.5% | 11.6% | 37.9% | |
Outcome Measurements Performed in the Same Manner | AJSM | 91.9% | 1.4% | 6.8% |
JBJS | 95.3% | 0.9% | 3.8% | |
JOR | 100.0% | 0.0% | 0.0% | |
OC | 97.2% | 0.0% | 2.8% | |
SJ | 87.5% | 0.0% | 12.5% | |
Mean
| 94.4% | 0.5% | 5.2% | |
Interventions Administration by Similarly Trained Individuals | AJSM | 79.7% | 1.4% | 18.9% |
JBJS | 48.1% | 1.9% | 50.0% | |
JOR | 14.3% | 0.0% | 85.7% | |
Osteo | 0.0% | 0.0% | 100.0% | |
SJ | 12.5% | 0.0% | 87.5% | |
Mean
| 30.9% | 0.7% | 68.4% | |
Description of Compliance With the Intervention | AJSM | 77.0% | 21.6% | 1.4% |
JBJS | 64.2% | 35.8% | 0.0% | |
JOR | 28.6% | 71.4% | 0.0% | |
OC | 83.3% | 16.7% | 0.0% | |
SJ | 56.3% | 43.8% | 0.0% | |
Mean
| 61.9% | 37.9% | 0.3% | |
Intention-To-Treat Analysis | AJSM | 39.2% | 2.7% | 58.1% |
JBJS | 39.6% | 1.9% | 58.5% | |
JOR | 14.3% | 0.0% | 85.7% | |
Osteo | 63.9% | 0.0% | 36.1% | |
SJ | 50.0% | 0.0% | 50.0% | |
Mean
| 41.4% | 0.9% | 57.7% | |
Was Clustering Accounted for in the Analysis? | AJSM | 0.0% | 0.0% | 100.0% |
JBJS | 0.9% | 0.0% | 99.1% | |
JOR | 0.0% | 0.0% | 100.0% | |
OC | 0.0% | 0.0% | 100.0% | |
SJ | 0.0% | 0.0% | 100.0% | |
Mean
| 0.2% | 0.0% | 99.8% | |
Were the Groups Similar at Baseline? | AJSM | 74.3% | 4.1% | 21.6% |
JBJS | 71.7% | 6.6% | 21.7% | |
JOR | 42.9% | 0.0% | 57.1% | |
OC | 63.9% | 25.0% | 11.1% | |
SJ | 68.8% | 6.3% | 25.0% | |
Mean
| 64.3% | 8.4% | 27.3% |
Randomization | Yes (%) | No (%) | Not reported (%) |
---|---|---|---|
Spine& Neck | 14(60.9) | 0(0) | 9(39.1) |
Upper Extremity | 32(78.1) | 3(7.3) | 6(14.6) |
Lower Extremity | 112(67.9) | 14(8.5) | 39(23.6) |
Mixed | 7(70.0) | 0(0) | 3(30.0) |
Allocation concealment
| |||
Spine& Neck | 14(60.9) | 0(0) | 9(39.1) |
Upper Extremity | 32(78.1) | 3 (7.3) | 6(14.6) |
Lower Extremity | 111(67.3) | 12(7.3) | 42(25.5) |
Mixed | 7(70.0) | 0(0) | 3(30.0) |
Blinding of Participants
| |||
Spine& Neck | 6(26.1) | 7(30.4) | 10(43.5) |
Upper Extremity | 6(14.6) | 8(19.5) | 27(65.9) |
Lower Extremity | 35(21.2) | 34(20.6) | 96(58.2) |
Mixed | 2(20.0) | 2(20.0) | 6(60.0) |
Blinding of Outcome Assessors
| |||
Spine& Neck | 11(47.8) | 3(13.0) | 9(39.1) |
Upper Extremity | 18(43.9) | 10(24.4) | 13(31.7) |
Lower Extremity | 82(49.7) | 24(14.6) | 59(35.8) |
Mixed | 7(70.0) | 1(10.0) | 2(20.0) |
Outcome Measurement
| |||
Spine& Neck | 21(91.3) | 0(0) | 2(8.7) |
Upper Extremity | 39(95.1) | 0(0) | 2(4.9) |
Lower Extremity | 156(94.6) | 2(1.2) | 7(4.2) |
Mixed | 9(90.0) | 0(0) | 1(10.0) |
Similarly Trained Individuals
| |||
Spine& Neck | 5(21.7) | 0(0) | 18(78.3) |
Upper Extremity | 24(58.5) | 1(2.4) | 16(39.0) |
Lower Extremity | 81(49.1) | 2(1.2) | 82(49.7) |
Mixed | 3(30.0) | 0(0) | 7(70.0) |
Compliance with Intervention
| |||
Spine& Neck | 13(56.5) | 10(43.5) | 0(0) |
Upper Extremity | 29(70.7) | 12(29.3) | 0(0) |
Lower Extremity | 119(72.1) | 45(27.3) | 1(0.6) |
Mixed | 5(50.0) | 5(50.0) | 0(0) |
Intent to Treat Analysis
| |||
Spine& Neck | 9(39.1) | 1(4.4) | 13(56.5) |
Upper Extremity | 20(48.8) | 1(2.4) | 20(48.8) |
Lower Extremity | 70(42.4) | 2(1.2) | 93(56.4) |
Mixed | 4(40.0) | 0(0) | 6(60.0) |
Clustering
| |||
Spine& Neck | 0(0) | 0(0) | 23(100) |
Upper Extremity | 0(0) | 0(0) | 41(100) |
Lower Extremity | 1(0.6) | 0(0) | 164(99.4) |
Mixed | 0(0) | 0(0) | 10(100) |
Similar at Baseline
| |||
Spine& Neck | 17(73.9) | 1(4.4) | 5(21.7) |
Upper Extremity | 30(73.2) | 0(0) | 11(26.8) |
Lower Extremity | 117(70.9) | 16(9.7) | 32(19.4) |
Mixed | 4(40.0) | 3(30.0) | 3(30.0) |
Randomization | Y | N | DK |
---|---|---|---|
Adult reconstruction | 33(71.7) | 3(6.5) | 10(21.7) |
Pediatric Orthopaedic Surgery | 5(71.4) | 2(28.6) | 0(0) |
Sports Medicine | 50(71.4) | 6(8.6) | 14(20.0) |
Trauma | 13(86.7) | 1(6.7) | 1(6.7) |
Foot and Ankle | 20(69.0) | 2(6.9) | 7(24.1) |
Hand and Upper Extremity | 11(84.6) | 0(0) | 2(15.4) |
Spine | 13(56.5) | 0(0) | 10(43.5) |
OA | 20(57.1) | 3(8.6) | 12(34.3) |
Allocation Concealment
| |||
Adult reconstruction | 33(71.7) | 3(6.5) | 10(21.7) |
Pediatric Orthopaedic Surgery | 5(71.4) | 2(28.6) | 0(0) |
Sports Medicine | 48(68.6) | 5(7.1) | 17(24.3) |
Trauma | 13(86.7) | 1(6.7) | 1(6.7) |
Foot and Ankle | 20(69.0) | 2(6.9) | 7(24.1) |
Hand and Upper Extremity | 11(84.6) | 0(0) | 2(15.4) |
Spine | 13(56.5) | 0(0) | 10(43.5) |
OA | 21(60.) | 2(5.7) | 12(34.3) |
Blinding of Participants
| |||
Adult reconstruction | 10(21.7) | 9(19.6) | 27(58.7) |
Pediatric Orthopaedic Surgery | 2(28.6) | 4(57.1) | 1(14.3) |
Sports Medicine | 10(14.3) | 10(14.3) | 50(71.4) |
Trauma | 3(20.0) | 5(33.3) | 7(46.7) |
Foot and Ankle | 5(17.2) | 9(31.0) | 15(51.7) |
Hand and Upper Extremity | 3(23.1) | 2(15.4) | 8(61.5) |
Spine | 5(21.7) | 7(30.4) | 11(47.8) |
OA | 11(31.4) | 5(14.3) | 19(54.3) |
Blinding of Assessors
| |||
Adult reconstruction | 20(43.5) | 8(17.4) | 18(39.1) |
Pediatric Orthopaedic Surgery | 3(42.9) | 2(28.6) | 2(28.6) |
Sports Medicine | 34(48.6) | 10(14.3) | 26(37.1) |
Trauma | 9(60.0) | 3(20.0) | 3(20.0) |
Foot and Ankle | 14(48.3) | 6(20.7) | 9(31.0) |
Hand and Upper Extremity | 6(46.2) | 4(30.8) | 3(23.1) |
Spine | 10(43.5) | 3(13.0) | 10(43.5) |
OA | 22(62.9) | 1(2.9) | 12(34.3) |
Outcome Measurement
| |||
Adult reconstruction | 44(95.7) | 1(2.2) | 1(2.2) |
Pediatric Orthopaedic Surgery | 7(100) | 0 (0) | 0 (0) |
Sports Medicine | 63(90.0) | 1(1.4) | 6(8.6) |
Trauma | 14(93.3) | 0(0) | 1(6.7) |
Foot and Ankle | 28(96.6) | 0(0) | 1(3.5) |
Hand and Upper Extremity | 13(100) | 0(0) | 0(0) |
Spine | 21(91.3) | 0(0) | 2(8.7) |
OA | 34(97.1) | 0(0) | 1(2.9) |
Similarly Trained Individuals
| |||
Adult reconstruction | 25(54.4) | 0(0) | 21(45.7) |
Pediatric Orthopaedic Surgery | 3(42.9) | 0(0) | 4(57.1) |
Sports Medicine | 54(77.1) | 1(1.4) | 15(21.4) |
Trauma | 6(40.0) | 1(6.7) | 8(53.3) |
Foot and Ankle | 17(58.6) | 1(3.5) | 11(37.9) |
Hand and Upper Extremity | 4(30.8) | 0(0) | 9(69.2) |
Spine | 4(17.4) | 0(0) | 19(82.6) |
OA | 0(0) | 0(0) | 35(100) |
Compliance with Intervention
| |||
Adult reconstruction | 32(69.6) | 14(30.4) | 0(0) |
Pediatric Orthopaedic Surgery | 5(71.4) | 2(28.6) | 0(0) |
Sports Medicine | 53(75.7) | 17(24.3) | 0(0) |
Trauma | 9(60.0) | 6(40.0) | 0(0) |
Foot and Ankle | 18(62.1) | 10(34.5) | 1(3.5) |
Hand and Upper Extremity | 8(61.5) | 5(38.5) | 0(0) |
Spine | 12(52.2) | 11(47.8) | 0(0) |
OA | 29(82.9) | 6(17.1) | 0(0) |
Intent to Treat Analysis
| |||
Adult reconstruction | 14(30.4) | 1(2.2) | 31(67.4) |
Pediatric Orthopaedic Surgery | 5(71.4) | 0(0) | 2(28.6) |
Sports Medicine | 26(37.1) | 2(2.9) | 42(60.0) |
Trauma | 6(40.0) | 0(0) | 9(60.0) |
Foot and Ankle | 15(51.7) | 0(0) | 14(48.3) |
Hand and Upper Extremity | 7(52.9) | 0(0) | 6(46.2) |
Spine | 8(34.8) | 1(4.4) | 14(60.9) |
OA | 22(62.9) | 0(0) | 13(37.1) |
Clustering
| |||
Adult reconstruction | 1(2.2) | 0(0) | 45(97.8) |
Pediatric Orthopaedic Surgery | 0(0) | 0(0) | 7(100) |
Sports Medicine | 0(0) | 0(0) | 70(100) |
Trauma | 0(0) | 0(0) | 15(100) |
Foot and Ankle | 0(0) | 0(0) | 29(100) |
Hand and Upper Extremity | 0(0) | 0(0) | 13(100) |
Spine | 0(0) | 0(0) | 23(100) |
OA | 0(0) | 0(0) | 35(100) |
Similar at Baseline
| |||
Adult reconstruction | 33(71.7) | 4(8.7) | 9(19.6) |
Pediatric Orthopaedic Surgery | 6(85.7) | 1(14.3) | 0(0) |
Sports Medicine | 54(77.1) | 3(4.3) | 13(18.6) |
Trauma | 9(60.0) | 2(13.3) | 4(26.7) |
Foot and Ankle | 19(65.5) | 0(0) | 10(34.5) |
Hand and Upper Extremity | 8(61.5) | 0(0) | 5(38.5) |
Spine | 17(73.9) | 1(4.4) | 5(21.7) |
OA | 22(62.9) | 9(25.7) | 4(11.4) |
Randomization | Y | N | DK |
---|---|---|---|
Asia | 11(64.7) | 4(23.5) | 2(11.8) |
Europe | 78(75.0) | 6(5.8) | 20(19.2) |
N. America | 66(62.9) | 7(6.7) | 32(30.5) |
Oceana | 9(81.8) | 0(0) | 2(18.2) |
Mixed | 1(50.0) | 0(0) | 1(50.0) |
Allocation Concealment
| |||
Asia | 11(64.7) | 4(23.5) | 2(11.8) |
Europe | 78(75.0) | 4(3.9) | 22(21.2) |
N. America | 66(62.9) | 7(6.7) | 32(30.5) |
Oceana | 8(72.7) | 0(0) | 3(27.3) |
Mixed | 1(50.0) | 0(0) | 1(50.0) |
Blinding of Participants
| |||
Asia | 2(11.8) | 0(0) | 15(88.2) |
Europe | 21(20.2) | 24(23.1) | 59(56.7) |
N. America | 23(21.9) | 24(22.9) | 58(55.2) |
Oceana | 2(18.2) | 3(27.3) | 6(54.6) |
Mixed | 1(50.0) | 0(0) | 1(50.0) |
Blinding of Assessors
| |||
Asia | 9(52.9) | 2(11.8) | 6(35.3) |
Europe | 51(49.0) | 22(21.2) | 31(29.8) |
N. America | 51(48.6) | 13(12.4) | 41(39.1) |
Oceana | 6(54.6) | 1(9.1) | 4(36.4) |
Mixed | 1(50.0) | 0(0) | 1(50.0) |
Outcome Measurement
| |||
Asia | 15(88.2) | 1(5.9) | 1(5.9) |
Europe | 99(95.2) | 0(0) | 5(4.8) |
N. America | 99(94.3) | 1(1.0) | 5(4.8) |
Oceana | 10(90.0) | 0(0) | 1(9.1) |
Mixed | 2(100) | 0(0) | 0(0) |
Similarly Trained Individuals
| |||
Asia | 10(58.8) | 0(0) | 7(41.2) |
Europe | 54(51.9) | 1(1.0) | 49(47.1) |
N. America | 46(43.8) | 2(1.9) | 57(54.3) |
Oceana | 3(27.3) | 0(0) | 8(72.7) |
Mixed | 0(0) | 0(0) | 2(100) |
Compliance with Intervention
| |||
Asia | 11(64.7) | 5(29.4) | 1(5.9) |
Europe | 76(73.1) | 28(26.9) | 0(0) |
N. America | 69(65.7) | 36(34.3) | 0(0) |
Oceana | 9(81.8) | 2(18.2) | 0(0) |
Mixed | 1(50.0) | 1(50.0) | 0(0) |
Intent to Treat Analysis
| |||
Asia | 6(6.1) | 0(0) | 11(64.7) |
Europe | 47(45.2) | 1(1.0) | 56(53.9) |
N. America | 43(41.0) | 3(2.9) | 59(56.2) |
Oceana | 5(45.5) | 0(0) | 6(54.6) |
Mixed | 2(100) | 0(0) | 0(0) |
Clustering
| |||
Asia | 0(0) | 0(0) | 17(100) |
Europe | 0(0) | 0(0) | 104(100) |
N. America | 1(1.0) | 0(0) | 104(99.1) |
Oceana | 0(0) | 0(0) | 11(100) |
Mixed | 0(0) | 0(0) | 2(100) |
Similar at Baseline
| |||
Asia | 13(76.5) | 1(5.9) | 3(17.7) |
Europe | 67(64.4) | 8(7.7) | 29(27.9) |
N. America | 79(75.2) | 9(8.6) | 17(16.2) |
Oceana | 7(63.6) | 2(18.2) | 2(18.2) |
Mixed | 2(100) | 0(0) | 0(0) |
Randomization | Y | N | DK |
---|---|---|---|
Size < 51 | 35(61.4) | 5(8.8) | 17(29.8) |
51 ≤ size < 81 | 41(70.7) | 5(8.6) | 12(20.7) |
81 ≤ size < 158 | 53(84.1) | 3(4.8) | 7(11.1) |
Size ≥ 158 | 36(59.0) | 4(6.6) | 21(34.4) |
Allocation Concealment
| |||
Size < 51 | 33(57.9) | 4(7.0) | 20(35.1) |
51 ≤ size < 81 | 42(72.4) | 5(8.6) | 11(19.0) |
81 ≤ size < 158 | 52(82.5) | 3(4.8) | 8(12.7) |
Size ≥ 158 | 37(60.7) | 3(4.9) | 21(34.4) |
Blinding of Participants
| |||
Size < 51 | 9(15.8) | 10(17.5) | 38(66.7) |
51 ≤ size < 81 | 9(15.5) | 10(17.2) | 39(67.2) |
81 ≤ size < 158 | 15(23.8) | 19(30.2) | 29(46.0) |
Size ≥ 158 | 16(26.2) | 12(19.7) | 32(54.1) |
Blinding of Assessors
| |||
Size < 51 | 25(43.9) | 7(12.3) | 25(43.9) |
51 ≤ size < 81 | 30(51.7) | 10(17.2) | 18(31.0) |
81 ≤ size < 158 | 34(54.0) | 9(14.3) | 20(31.8) |
Size ≥ 158 | 29(47.5) | 12(19.7) | 20(32.8) |
Outcome Measurement
| |||
Size < 51 | 54(94.7) | 1(1.8) | 2(3.5) |
51 ≤ size < 81 | 54(93.1) | 1(1.7) | 3(5.2) |
81 ≤ size < 158 | 61(96.8) | 0(0) | 2(3.2) |
Size ≥ 158 | 56(91.8) | 0(0) | 5(8.2) |
Similarly Trained Individuals
| |||
Size < 51 | 29(50.9) | 1(1.8) | 27(47.4) |
51 ≤ size < 81 | 38(65.5) | 0(0) | 20(34.5) |
81 ≤ size < 158 | 31(49.2) | 2(3.2) | 30(47.6) |
Size ≥ 158 | 15(24.6) | 0(0) | 46(75.4) |
Compliance with Intervention
| |||
Size < 51 | 28(49.1) | 29(5.9) | 0(0) |
51 ≤ size < 81 | 39(67.2) | 18(31.0) | 1(1.7) |
81 ≤ size < 158 | 53(84.1) | 10(15.9) | 0(0) |
Size ≥ 158 | 46(75.4) | 15(24.6) | 0(0) |
Intent to Treat Analysis
| |||
Size < 51 | 10(17.5) | 0(0) | 47(82.5) |
51 ≤ size < 81 | 15(25.9) | 0(0) | 43(74.1) |
81 ≤ size < 158 | 39(61.9) | 1(1.6) | 23(36.5) |
Size ≥ 158 | 39(63.9) | 3(4.9) | 19(31.1) |
Clustering
| |||
Size < 51 | 0(0) | 0(0) | 57(100) |
51 ≤ size < 81 | 0(0) | 0(0) | 58(100) |
81 ≤ size < 158 | 1(1.6) | 0(0) | 62(98.4) |
Size ≥ 158 | 0(0) | 0(0) | 61(100) |
Similar at Baseline
| |||
Size < 51 | 37(64.9) | 2(3.5) | 18(31.6) |
51 ≤ size < 81 | 39(67.2) | 3(5.2) | 16(27.6) |
81 ≤ size < 158 | 47(74.6) | 7(11.1) | 9(14.3) |
Size ≥ 158 | 45(73.8) | 8(13.1) | 8(13.1) |
Results
Journal title* | Impact factor | Yes† | No | Not reported |
---|---|---|---|---|
AJSM (N = 74) | 3.80 | 0.565 | 0.082 | 0.353 |
JBJS (N = 106) | 2.97 | 0.536 | 0.106 | 0.358 |
JOR (N = 7) | 2.97 | 0.386 | 0.071 | 0.543 |
OC (N = 36) | 3.95 | 0.519 | 0.075 | 0.406 |
SJ (N = 16) | 3.02 | 0.450 | 0.106 | 0.444 |
Mean
| 0.491 | 0.088 | 0.421 |