| Literature DB >> 25568407 |
S A Sabah1, J Henckel2, E Cook3, R Whittaker4, H Hothi4, Y Pappas3, G Blunn4, J A Skinner1, A J Hart1.
Abstract
Arthroplasty registries are important for the surveillance of joint replacements and the evaluation of outcome. Independent validation of registry data ensures high quality. The ability for orthopaedic implant retrieval centres to validate registry data is not known. We analysed data from the National Joint Registry for England, Wales and Northern Ireland (NJR) for primary metal-on-metal hip arthroplasties performed between 2003 and 2013. Records were linked to the London Implant Retrieval Centre (RC) for validation. A total of 67,045 procedures on the NJR and 782 revised pairs of components from the RC were included. We were able to link 476 procedures (60.9%) recorded with the RC to the NJR successfully. However, 306 procedures (39.1%) could not be linked. The outcome recorded by the NJR (as either revised, unrevised or death) for a primary procedure was incorrect in 79 linked cases (16.6%). The rate of registry-retrieval linkage and correct assignment of outcome code improved over time. The rates of error for component reference numbers on the NJR were as follows: femoral head category number 14/229 (5.0%); femoral head batch number 13/232 (5.3%); acetabular component category number 2/293 (0.7%) and acetabular component batch number 24/347 (6.5%). Registry-retrieval linkage provided a novel means for the validation of data, particularly for component fields. This study suggests that NJR reports may underestimate rates of revision for many types of metal-on-metal hip replacement. This is topical given the increasing scope for NJR data. We recommend a system for continuous independent evaluation of the quality and validity of NJR data. ©2015 The British Editorial Society of Bone & Joint Surgery.Entities:
Keywords: Arthroplasty; Hip; Metal-on-Metal; Registry
Mesh:
Substances:
Year: 2015 PMID: 25568407 PMCID: PMC4548488 DOI: 10.1302/0301-620X.97B1.35279
Source DB: PubMed Journal: Bone Joint J ISSN: 2049-4394 Impact factor: 5.082
Fields for validation
| NHS number | Primary key | Unique ten-digit United Kingdom National Health Service identifier |
| First name | String | - |
| Surname | String | - |
| Date of birth | Continuous | Male or female |
| Gender | Dichotomous | - |
| Age at primary (yrs) | Continuous | - |
| Primary operation date | Continuous | - |
| Primary surgical unit description | Categorical | RC field recoded to NJR |
| Acetabular component brand | Categorical | RC field recoded to NJR |
| Acetabular component ODEP rating | Categorical | 10A, 7A, 7B, 5A, 5B, 3A, discontinued, pre-entry or unclassified |
| Component type | Dichotomous | ‘Resurfacing’ or ‘Modular’ |
| Acetabular component size /mm | Discrete | -NJR field recoded from manufacturer guides to provide outer diameter |
| -RC field from etching on component | ||
| Head size (mm) | Dichotomous | Etched on component. |
| Implant side | Dichotomous | Left or right |
| Head cat number | Categorical | -Category number indicating model of head component |
| -Referenced in manufacturer guide | ||
| -Etched on component | ||
| Head batch number | Categorical | -Batch numbers indicating time of component production |
| -Free-text field on NJR | ||
| -Etched on component | ||
| Acetabular component cat number | Categorical | -Category numbers indicating model of acetabular component |
| -Referenced in manufacturer guide | ||
| -Etched on component | ||
| Acetabular component batch number | Categorical | -Batch numbers indicating time of component production |
| -Free-text field on NJR | ||
| -Etched on component | ||
| NJR outcome code | Categorical | Revised, unrevised or died |
Description of field-level linkage between NJR and RC datasets. Component fields were completed at the RC from etching markings on the component NJR, National Joint Registry for England, Wales and Northern Ireland; RC, Retrieval Centre; ODEP, Orthopaedic Device Evaluation Panel
Detailed data validation of National Joint Registry (NJR) primary database
| Field | Max | |||||||
|---|---|---|---|---|---|---|---|---|
| Age at primary (yrs) | 67045 | 0 | 0 | 0.00 | 58.88 | 11.12 | 12 | 105 |
| Gender | 67040 | 0 | 5 | 0.00 | Male: 40661 | - | - | - |
| Female: 26379 | ||||||||
| Primary operation date | 67045 | 0 | 0 | 0.00 | - | - | - | - |
| Surgical unit description | 67045 | 0 | 0 | 0.00 | 417 units | - | - | - |
| Acetabular component brand | 67044 | 0 | 1 | 0.00 | 51 brands | - | - | - |
| Acetabular component ODEP rating | 67044 | 0 | 1 | 0.00 | 10A: 22240 | - | - | - |
| 7A: 13354 | ||||||||
| 7B: 144 | ||||||||
| 5A: 7497 | ||||||||
| 5B: 2 | ||||||||
| 3A: 9342 | ||||||||
| Discontinued: 6346 | ||||||||
| Pre-entry: 7372 | ||||||||
| Unclassified: 747 | ||||||||
| Component type | 67044 | 0 | 1 | 0.00 | Resurfacing: 33996 | - | - | - |
| Modular: 33048 | ||||||||
| Side | 67045 | 0 | 0 | 0.00 | Left: 31584 | - | - | - |
| Right: 35461 | ||||||||
| Head size (mm) | 67044 | 0 | 1 | 0.00 | 44.90 | 6.98 | 22.25 | 60 |
| Acetabular component size (Inner diameter) (mm) | 51309 | 0 | 15 736 (All shell only) | 23.5 | 47.95 | 4.61 | 28.00 | 64 |
| Head cat number | 67044 | 0 | 1 | 0.00 | - | - | - | - |
| Head batch number | 66958 | 0 | 87 | 0.1 | - | - | - | - |
| Acetabular component cat number | 67044 | 0 | 1 | 0.00 | - | - | - | - |
| Acetabular component batch number | 66952 | 0 | 93 | 0.1 | - | - | - | - |
| Outcome code | 67044 | 0 | 1 | 0.00 | Revised: 5615 | - | - | - |
| Unrevised: 58257 | ||||||||
| Death: 3172 | ||||||||
Missing rate %, number missing / total number of records x 100; Max, maximum; Min, minimum; OOR, out of range; sd, standard deviation; Valid, total number of records (n = 67 045); number OOR, number missing Descriptive statistics for 67 045 records of metal-on-metal primary procedures recorded on the National Joint Registry from 1 April 2003 to 1 November 2013. Records without NHS numbers were excluded as they were not eligible for linkage
Retrieval Centre (RC) random sample validation
| Date of birth | 0 | 0 | 49 | |
| Gender | 0 | 0 | 49 | |
| Primary operation date | 5 | 2 | 42 | |
| Surgical unit description | 6 | 1 | 42 | |
| Acetabular component brand | 0 | 0 | 49 | |
| Acetabular component ODEP rating | 0 | 0 | 49 | |
| Component type | 0 | 0 | 49 | |
| Side | 0 | 0 | 49 | |
| Head size | 1 | 0 | 48 | |
| Acetabular component size | 3 | 0 | 46 | |
| Head cat number | 27 | 0 | 22 | |
| Head batch number | 19 | 0 | 30 | |
| Acetabular component cat number | 2 | 0 | 47 | |
| Acetabular component batch number | 23 | 0 | 16 | |
| RC outcome code | 0 | 0 | 49 | |
A total of 49 records were selected at random from the RC to examine the accuracy of data entry. The component and referral form were re-examined, re-entered and then validated against the original entry. ‘Primary operation date’ errors were typographical. The ‘surgical unit description’ error reflected incorrect re-coding of the hospital during field-level linkage ODEP, Orthopaedic Data Evaluation Panel
Validation of linked records
| Date of birth | 476 | 0 | 10 | 466 | |
| Gender | 476 | 0 | 0 | 476 | |
| Primary operation date | 418 | 58 | 51 | 367 | |
| Surgical unit description | 445 | 31 | 5 | 440 | |
| Acetabular component brand | 476 | 0 | 0 | 476 | |
| Cup ODEP rating | 476 | 0 | 0 | 476 | |
| Component type | 476 | 0 | 16 | 460 | |
| Side | 405 | 71 | 9 | 396 | |
| Head size | 459 | 17 | 98 | 361 | |
| Acetabular component size | 439 | 37 | 13 | 426 | |
| Head cat number | 242 | 235 | 14 | 229 | |
| Head batch number | 245 | 232 | 13 | 232 | |
| Acetabular component cat number | 295 | 182 | 2 | 293 | |
| Acetabular component batch number | 371 | 106 | 24 | 347 | |
| Outcome code | 476 | 0 | 79 | 397 | |
Results of validation of 476 linked primary procedures. Retrieval Centre (RC) data were used as the reference. Errors for patient demographic data can be considered as discrepancies between the datasets, since checking to the source was not performed. Errors for component fields should be considered as ‘true’ errors, since the component was physically examined at the RC. The error rate for ‘outcome code’ represents under-reporting of component failure rate on the National Joint Registry ODEP, Orthopaedic Data Evaluation Panel
Detailed analysis of errors
| Date of birth | 10 | RC data-entry cross-checked with NHS Spine | RC | -Incorrect data supplied to RC by referring surgeon (n = 3) |
| -Typographical error (n = 7) | ||||
| Gender | 0 | - | - | - |
| Primary operation date | 51 | No source verification performed | NJR or RC | Data entry error on either database |
| Surgical unit description | 5 | No source verification performed | NJR or RC | Data entry error on either database |
| Acetabular component brand | 0 | - | - | - |
| Acetabular component ODEP rating | 0 | - | - | - |
| Component type | 16 | Component +/- radiograph re-examined | NJR | Error at level of NJR catalogue (incorrect component selection, catalogue entry error or both) |
| Side | 9 | No source verification performed | NJR or RC | Data entry error on either database. No radiographs available for examination for these components. |
| Head size | 98 | Component re-examined | NJR | Error at level of NJR catalogue (incorrect component selection, catalogue entry error or both) |
| Acetabular component size | 13 | Component re-examined | NJR | Error at level of NJR catalogue (incorrect component selection, catalogue entry error or both) |
| Head cat number | 12 | Component re-examined | NJR | Error at level of NJR catalogue (incorrect component selection, catalogue entry error or both) |
| Head batch number | 13 | Component re-examined | NJR | Nonsense data entered in free-text field |
| Acetabular component cat number | 2 | Component re-examined | NJR | Error at level of NJR catalogue (incorrect component selection, catalogue entry error or both) |
| Acetabular component batch number | 24 | Component re-examined | NJR | Nonsense data entered in free-text field |
| Outcome code | 79 | None required | NJR | (i) Incorrect coding of outcome as 'death' (n = 1) |
| (ii) Failure of NJR to link primary procedure to revision procedure (n = 78). Explanations: a) reporting of revision to RC only and b) absence of ‘linkability’ | ||||
NJR, National Joint Registry; RC, Retrieval Centre
Detailed data validation of linked Retrieval Centre (RC) records.
| Field | ||||||||
|---|---|---|---|---|---|---|---|---|
| Age at primary (yrs) | 418 | 0 | 58 | 12.2 | 56.29 | 10.32 | 25 | 107 |
| Gender | 476 | 0 | 0 | 0.00 | Male: 209 | |||
| Female: 267 | ||||||||
| Primary operation date | 418 | 0 | 58 | 12.2 | - | |||
| Surgical unit description | 445 | 0 | 31 | 6.5 | 170 units | |||
| Acetabular component brand | 476 | 0 | 0 | 0.00 | 15 brands | |||
| Acetabular component ODEP rating | 476 | 0 | 0 | 0.00 | 10A: 167 | |||
| 7A: 27 | ||||||||
| 7B: 0 | ||||||||
| 5A: 77 | ||||||||
| 5B: 0 | ||||||||
| 3A: 47 | ||||||||
| Discontinued: 115 | ||||||||
| Pre-entry: 42 | ||||||||
| Unclassified: 1 | ||||||||
| Component type | 476 | 0 | 0 | 0.00 | Resurfacing: 292 | |||
| Modular: 184 | ||||||||
| Side | 466 | 0 | 10 | 2.1 | Left: 226 | |||
| Right: 240 | ||||||||
| Head size (mm) | 459 | 0 | 17 | 3.6 | 46.34 | 4.59 | 35 | 58 |
| Acetabular component size (outer diameter) (mm) | 452 | 0 | 24 | 5.0 | 53.33 | 3.91 | 44 | 66 |
| Head cat number | 241 | 0 | Total: 235 | 49.4 | - | |||
| No head: 5 | ||||||||
| Not visible: 230 | ||||||||
| Head batch number | 245 | 0 | Total: 231 | 48.5 | - | |||
| No head: 5 | ||||||||
| Not visible: 226 | ||||||||
| Acetabular component cat number | 295 | 0 | Total: 181 | 38.0 | - | |||
| No cup: 24 | ||||||||
| Not visible: 157 | ||||||||
| Acetabular component batch number | 373 | 0 | Total: 103 | 21.6 | - | |||
| No cup: 24 | ||||||||
| Not visible: 79 | ||||||||
| Outcome code | 476 | 0 | 0 | 0.00 | Revised: 476 | |||
| Unrevised: 0 | ||||||||
| Death: 0 | ||||||||
Missing rate %, number missing / total number of records x 100; Max, maximum; Min, minimum; OOR, out of range; sd, standard deviation; ODEP, Orthopaedic Data Evaluation Panel; Valid, total number of linked records (n = 476); number OOR, number missing Descriptive statistics for 476 records linked between National Joint Registry and RC. Linkage was performed on a patient-level using NHS number and then on a procedure-level as indicated in the methods