| Literature DB >> 34195624 |
J Michael Anderson1, Aaron Stafford2, Samuel Jellison1, Matt Vassar1.
Abstract
PURPOSE: Outcomes of randomized controlled trials (RCTs) have been shown to influence clinical decision making. Thus, the quality and reliability of these outcomes are essential for both patients and medical care providers. To date, no study has assessed the quality of intervention reporting of RCTs in orthopaedics. The aim of this study was to evaluate the quality of intervention reporting of published RCTs in the field of orthopaedics using the Template for Intervention Description and Replication (TIDieR) checklist.Entities:
Year: 2021 PMID: 34195624 PMCID: PMC8220564 DOI: 10.1016/j.asmr.2020.09.019
Source DB: PubMed Journal: Arthrosc Sports Med Rehabil ISSN: 2666-061X
Fig 1Flowchart of included and excluded randomized controlled trials (RCTs). (TIDieR, Template for Intervention Description and Replication.)
Summary of Journal Endorsement of CONSORT and/or TIDieR Guidelines for RCT Intervention Reporting
| Journal Name | Endorsement of CONSORT | Endorsement of TIDieR |
|---|---|---|
| Yes | No | |
| No | No | |
| Yes | No | |
| Yes | No | |
| Yes | No | |
| Yes | No | |
| Yes | No | |
| No | No | |
| Yes | No | |
| Yes | No |
CONSORT, Consolidated Standards of Reporting Trials; RCT, randomized controlled trial; TIDieR, Template for Intervention Description and Replication.
Baseline Characteristics of Sampled RCTs from Top Orthopaedic Surgery Journals
| Characteristic | Google-Form Response | n (%) |
|---|---|---|
| Name of journal | 40 (22.9) | |
| 32 (18.3) | ||
| 21 (12) | ||
| 20 (11.4) | ||
| 15 (8.6) | ||
| 14 (8.0) | ||
| 14 (8.0) | ||
| 12 (6.8) | ||
| 7 (4.0) | ||
| Source of funding | Not mentioned | 64 (36.6) |
| Industry | 36 (20.6) | |
| None | 30 (17.1) | |
| Public | 20 (11.4) | |
| Mixed | 11 (6.3) | |
| Private | 9 (5.1) | |
| Hospital | 5 (2.9) | |
| Hypothesis | Superiority | 91 (47.9) |
| Not sure | 64 (33.7) | |
| Equivalence | 21 (11.1) | |
| Other | 8 (4.2) | |
| Noninferiority | 4 (2.1) | |
| Mixed (superiority and equivalence) | 2 (1.1) | |
| Study design | Parallel arm | 172 (98.3) |
| Cluster | 3 (1.7) | |
| Intervention | Procedure | 69 (39.4) |
| Drug | 39 (22.3) | |
| Other | 36 (20.6) | |
| Device | 25 (14.3) | |
| Mixed | 6 (3.4) | |
| Blinding | No blinding | 76 (43.4) |
| Single blind | 39 (22.3) | |
| Double blind | 60 (34.3) | |
| No. of participants per trial | <60 | 63 (36.0) |
| 60-170 | 88 (50.3) | |
| 171-280 | 15 (8.6) | |
| >280 | 9 (5.1) | |
| Country where trial was conducted | Outside of United States | 133 (76) |
| United States | 40 (22.8) | |
| Both | 1 (0.6) | |
| Not mentioned | 1 (0.6) | |
| Conducting center | Single center | 148 (84.6) |
| Multicenter | 27 (15.4) | |
| RCTs with CONSORT endorsement | Yes | 48 (27.4) |
| No | 127 (72.6) | |
| RCTs with TIDieR endorsement | Yes | 0 (0) |
| No | 175 (100) | |
| Trial prospectively registered | Yes | 63 (36) |
| No | 112 (64) |
NOTE. A total of 175 RCTs were included in the analysis.
CONSORT, Consolidated Standards of Reporting Trials; RCT, randomized controlled trial; TIDieR, Template for Intervention Description and Replication.
Fig 2Interrupted time-series analysis of mean percentage of adherence to Template for Intervention Description and Replication (TIDieR) items.
Percentage of Adherence to TIDieR Checklist Items by Prespecified Period and Overall
| TIDieR Checklist Item | Trials Published Between 2011 and 2013 (n = 73) | Trials Published Between 2016 and 2018 (n = 102) | Trials Published Between 2011 and 2018 (N = 175) | |||
|---|---|---|---|---|---|---|
| Adherence to Checklist Item, n (%) | 95% CI | Adherence to Checklist Item, n (%) | 95% CI | Adherence to Checklist Item, n (%) | 95% CI | |
| 1. Brief name | 73 (100) | 1.000-1.000 | 102 (100) | 1.000-1.000 | 175 (100) | 1.000-1.000 |
| 2. Why/rationale? | 73 (100) | 1.000-1.000 | 102 (100) | 1.000-1.000 | 175 (100) | 1.000-1.000 |
| 3. What materials? | 50 (68.5) | 0.578-0.791 | 85 (83.3) | 0.761-0.906 | 135 (77.1) | 0.709-0.833 |
| 4. What procedures? | 53 (72.6) | 0.624-0.828 | 81 (79.4) | 0.716-0.873 | 134 (76.6) | 0.703-0.828 |
| 5. Who provided? | 40 (54.8) | 0.434-0.662 | 55 (53.9) | 0.442-0.636 | 95 (54.3) | 0.469-0.617 |
| 6. How? | 68 (93.2) | 0.874-0.989 | 100 (98.0) | 0.953-1.007 | 168 (96) | 0.931-0.989 |
| 7. Where? | 46 (63) | 0.519-0.741 | 72 (70.6) | 0.617-0.794 | 118 (67.4) | 0.605-0.744 |
| 8. When and how much (dose)? | 68 (93.2) | 0.874-0.990 | 100 (98.0) | 0.953-1.007 | 168 (96) | 0.931-0.989 |
| 9. Tailoring or personalization of intervention? | 8 (10.9) | 0.038-0.0.181 | 16 (15.7) | 0.086-0.227 | 24 (13.7) | 0.086-0.188 |
| 10. Modifications? | 5 (6.8) | 0.011-0.126 | 0 (0.0) | 0.000-0.000 | 5 (2.9) | 0.004-0.053 |
| 11. How well (planned) was intervention delivered? | 5 (6.8) | 0.011-0.126 | 10 (9.8) | 0.040-0.156 | 15 (8.6) | 0.044-0.127 |
| 12. To what extent (actual) was intervention delivered as planned? | 3 (4.1) | –0.004 to 0.087 | 11 (10.7) | 0.047-0.168 | 14 (8.0) | 0.040-0.120 |
CI, confidence interval; TIDieR, Template for Intervention Description and Replication.
Items were included in the calculation of the percentage of adherence if “completely” compliant with the TIDieR item.
Characteristics Associated With Intervention Reporting
| Characteristic | Variable | ||
|---|---|---|---|
| IRR | 95% CI | ||
| No. of authors | |||
| <4 | 1 | Reference | Reference |
| 4-7 | 0.97 | 0.313 | 0.92-1.03 |
| >7 | 1.99 | 0.971 | 0.92-1.09 |
| Funding source | |||
| Industry and private | 1 | Reference | Reference |
| Public and mixed funding sources | 1.05 | 0.059 | 1.00-1.10 |
| Not mentioned | 1.02 | 0.565 | 0.95-1.10 |
| None | 0.99 | 0.688 | 0.92-1.05 |
| Hypothesis | |||
| Superiority | 1 | Reference | Reference |
| All other hypotheses | 0.97 | 0.267 | 0.92-1.02 |
| Study design | |||
| Parallel arm | 1 | Reference | Reference |
| Crossover | 0.99 | 0.811 | 0.88-1.10 |
| Intervention type | |||
| Procedure | 1 | Reference | Reference |
| Drug | 1.02 | 0.471 | 0.96-1.09 |
| Non-procedure and non-drug | 1.05 | 0.084 | 0.99-1.10 |
| Blinding | |||
| No blinding | 1 | Reference | Reference |
| Blinding (single or double) | 0.99 | 0.489 | 0.96-1.02 |
| No. of participants | |||
| <60 | 1 | Reference | Reference |
| 60-170 | 0.96 | 0.069 | 0.92-1.00 |
| 171-280 | 0.97 | 0.669 | 0.84-1.12 |
| >280 | 1.00 | 0.984 | 0.86-1.16 |
| Location of trial | |||
| Outside of United States, multiple locations including United States, or not mentioned | 1 | Reference | Reference |
| United States | 0.95 | 0.011 | 0.92-0.99 |
| Conducting center | |||
| Single center | 1 | Reference | Reference |
| Multicenter | 0.92 | <0.001 | 0.89-0.95 |
| CONSORT endorsement by trial authors | |||
| No | 1 | Reference | Reference |
| Yes | 0.99 | 0.806 | 0.92-1.06 |
| TIDieR endorsement by trial authors | |||
| No | 1 | Reference | Reference |
| Yes | — | — | — |
| Trial registry | |||
| None | 1 | Reference | Reference |
| Yes, listed | 1.06 | 0.009 | 1.01-1.10 |
| No. of sources in which information was found | |||
| 1 | 1 | Reference | Reference |
| ≥2 | 1.02 | 0.304 | 0.98-1.06 |
CI, confidence interval; CONSORT, Consolidated Standards of Reporting Trials; IRR, incidence rate ratio; TIDieR, Template for Intervention Description and Replication.