Calibration of the Becton Dickinson FocalPoint GS slide profiler is essential for optimal performance: Avoiding the algorithm supersaturation cascade effect pitfall.

BACKGROUND: The MAVARIC study supported the use of the FocalPoint GS (FPGS) imaging system "No Further Review" (NFR) technology for cervical screening and recommended further investigation. A validation study (Nuttall et al.) was performed by Cervical Screening Wales before implementing the NFR slide reporting technology within the cervical screening program in Wales, United Kingdom. METHOD: A total of 45,317 SurePath liquid-based cytology cervical screening samples were submitted for FPGS scanning within four Welsh cytology laboratories between 2006 and 2011. The study, Computer Assisted Evaluation, Screening and Reporting, involved scanning the slides using the FPGS and comparing the results with manual screening performed under established Cervical Screening Wales protocols. RESULTS: An increased number of abnormal cases presented in the NFR reporting category, significantly greater than that previously encountered. This anomaly resulted in higher false-negative rates with potentially life-changing consequences for the screening participant. Subsequent investigation determined that this increase in cases created an algorithm cascade or "sump" effect, which resulted in an unprecedented increased number of samples categorized as NFR. This exceeded the calibration parameters set for the FPGS and was thought to be caused by an increase in the number of younger women attending for screening following the death of a young reality television celebrity from cervical cancer. CONCLUSION: Adequate and timely calibration of FPGS technology is vital for quality assurance of the results produced, particularly following events that may impact on cervical precancer incidence rates. Failure to do so can result in potentially catastrophic screening incidents that are avoidable.

A retrospective validation of the FocalPoint GS slide profiler NFR technology by analysis of interval disease outcomes compared with manual cytology.

BACKGROUND: To the authors' knowledge, published studies reporting on the performance of the FocalPoint GS (FPGS) imaging system have yielded conflicting results to date. However, the results of the MAVARIC study indicated that the FPGS "No Further Review" (NFR) aspect of the technology demonstrated potential and warranted further investigation. The current validation study was performed prior to implementing the NFR slide reporting technology within the routine cervical screening program in Wales, United Kingdom. METHODS: A total of 45,317 SurePath liquid-based cytology cervical screening samples were submitted for FPGS scanning by 4 Welsh laboratories between 2006 and 2011. The current study (Computer Assisted Evaluation, Screening and Reporting [CAESAR]), reports on a comparison between slides categorized as NFR (8130 slides) and slides manually screened as negative (93,473 slides). Both interventions had a subsequent negative quality control screen. RESULTS: The histological outcome rates of cervical intraepithelial neoplasia 2 (CIN-2) (high-grade squamous intraepithelial lesion or worse [HSIL+]) at 2 years and subsequently 3 years after an FPGS NFR result versus a manually screened negative result were compared. Significantly fewer cases were detected in the NFR cohort compared with the manually screened cohort (P = .043 at 2 years and P = .027 at 3 years). When these cases were subcategorized as cancers and precancers, the interval cancer prevalence between NFR and manually screened samples at 2 years and 3 years was similar; however, the interval precancer prevalence for FPGS NFR was significantly lower (P = .023 at 2 years and P = .026 at 3 years) at approximately one-half that of manual screening. CONCLUSIONS: The negative predictive potential of the FPGS NFR technology is higher than that of manual screening, and the technology has quality/throughput benefits to support and enhance a laboratory cervical screening service.

Early results of Latitude primary total elbow replacement with a minimum follow-up of 2 years.

BACKGROUND: The aim of this study was to present outcomes of primary Latitude total elbow replacement (TER) with a minimum follow-up of 2 years. METHODS: A retrospective cohort study was undertaken with prospective outcome data collection for the latest outcome. Included were 63 consecutive primary Latitude TERs in 58 patients performed during a period of 5 years at a specialist orthopedic hospital. RESULTS: The mean age of the patients was 62 years (33-85 years). Five primary TERs (4 patients) were lost to follow-up. The primary diagnosis was rheumatoid arthritis in 49, osteoarthritis in 8, and trauma in 6 elbows. The mean flexion-extension arc was 75° preoperatively and 97° postoperatively. Mean postoperative Elbex pain score was 19/100, and function score was 37/100. Mean postoperative scores were 42/100 for the Quick Disabilities of the Arm, Shoulder, and Hand and 38/50 for the elbow-specific American Shoulder and Elbow Surgeons assessment. Four patients died of unrelated causes, and 8 of 63 underwent further surgical intervention, including explantation and conversion from unlinked to linked implant. On radiographic review of 41 surviving TERs, aseptic radiologic loosening was observed of the humeral component in 4 elbows and of the ulnar component in 9. Seven elbows had no radial component, and of the remaining 34 elbows, 16 (47%) had signs of loosening of the radial implant. Complications included 1 heterotopic ossification, 1 olecranon fracture, and 3 further procedures for ulnar nerve entrapment. CONCLUSION: The results indicate that the early outcome of Latitude TER is comparable to that of other prostheses. There is concern about early radiologic loosening of the radial component.

Pyrocarbon Proximal Interphalangeal Joint Arthroplasty: Minimum Five-Year Follow-Up.

PURPOSE: To report the outcomes, complications, and survivorship of pyrocarbon proximal interphalangeal joint arthroplasty at a minimum of 5-year follow-up. METHODS: A review of 97 implants in 72 consecutive patients from our joint arthroplasty database was undertaken. Patient demographics, complications, further surgery, and implant revision were recorded. Objective outcome was assessed by grip strength, range of motion, and radiological assessment of alignment, loosening, and subsidence. Subjective outcome was assessed by Patient Evaluation Measure; Quick Disabilities of the Arm, Shoulder, and Hand score; and visual analog scores (0, best; 10, worst) for appearance, satisfaction, and pain. RESULTS: Diagnosis was osteoarthritis in 60 joints, rheumatoid arthritis in 12 joints, psoriatic arthritis in 11 joints, and trauma in 14 joints. The average follow-up was 118 months (range, 60-164 months). The mean arc of motion was 35° (range, 0° to 90°). There was no difference in grip strength between operated and nonoperated side. Of the 97 implants, 36 required additional surgery, of which 14 were revised and 22 required reconstruction around a retained implant. The average Patient Evaluation Measure and Quick Disabilities of the Arm, Shoulder and Hand scores were 33 (range, 10-69) and 35 (range, 0-93), respectively. Mean visual analog scores for pain, satisfaction, and appearance were 2 (range, 0-8), 7 (0-10), and 8 (0-10), respectively. All implants had a lucent line with nearly all classified as either Herren grade 2 or 3. Progressive loosening was seen in 48% of implants. Implant survival as assessed by Kaplan-Meier was 85% at both 5 and 10 years. CONCLUSIONS: Good pain relief and maintenance of preoperative arc of motion was achieved with no major deterioration over time. Most implant revisions were performed within 24 months of the index procedure. Currently progressive loosening was not translated into revision surgery. Implant revision rate was higher than with other prostheses. TYPE OF STUDY/LEVEL OF EVIDENCE: Therapeutic IV.

Pyrocarbon Metacarpophalangeal Joint Arthroplasty in Noninflammatory Arthritis: Minimum 5-Year Follow-Up.

PURPOSE: To report the outcomes, complications, and survivorship of pyrocarbon metacarpophalangeal joint arthroplasty in noninflammatory arthropathy at a minimum 5-year follow-up. METHODS: A retrospective review of 51 implants in 36 patients was undertaken. Patient demographics, complications, further surgery, and implant revision were recorded. Objective outcome was assessed by grip strength, range of motion, and radiological assessment of alignment, loosening, and subsidence. Subjective outcome was assessed by Patient Evaluation Measure, Quick Disabilities of the Arm, Shoulder and Hand score, and visual analog scores (0, best; 10, worst) for appearance, satisfaction, and pain. RESULTS: There were 35 index and 16 middle fingers. The average follow-up was 103 months (range, 60-172 months). The mean arc of motion was 54° (range, 20° to 80°). There was no difference in grip strength between operated and nonsurgical side. Six implants were revised, and 3 of these required additional surgery. The average Patient Evaluation Measure and Quick Disabilities of the Arm, Shoulder and Hand scores were 27 (range, 10-54) and 29 (range, 0-57), respectively. Mean visual analog scores for pain, satisfaction, and appearance were all 1 with the respective ranges being 0-7, 0-4, and 0-6. Most implants were Herren grade 1 lucency with the remaining 5 proximal and 12 distal implants being grade 2. Mean subsidence in the proximal component was 2 mm (range, 0-4 mm) and 1 mm (range, 0-3 mm) in the distal component. The degree of loosening or subsidence did not correlate with outcome. Implant survival as assessed by Kaplan-Meier was 88% at 10 years. CONCLUSIONS: Good pain relief, a functional range of motion, and high satisfaction were seen in the majority of patients. All implant revisions were performed within 18 months of the index procedure. This may represent technical issues rather than problems with the implant.

Inter-provider comparison of patient-reported outcomes: developing an adjustment to account for differences in patient case mix.

This paper describes the development of a methodology for the case-mix adjustment of patient-reported outcome measures (PROMs) data permitting the comparison of outcomes between providers on a like-for-like basis. Statistical models that take account of provider-specific effects form the basis of the proposed case-mix adjustment methodology. Indirect standardisation provides a transparent means of case mix adjusting the PROMs data, which are updated on a monthly basis. Recently published PROMs data for patients undergoing unilateral knee replacement are used to estimate empirical models and to demonstrate the application of the proposed case-mix adjustment methodology in practice. The results are illustrative and are used to highlight a number of theoretical and empirical issues that warrant further exploration. For example, because of differences between PROMs instruments, case-mix adjustment methodologies may require instrument-specific approaches. A number of key assumptions are made in estimating the empirical models, which could be open to challenge. The covariates of post-operative health status could be expanded, and alternative econometric methods could be employed.

The early migration of a partially cemented fluted pegged glenoid component using radiostereometric analysis.

BACKGROUND: Radiostereometric analysis measures the position of rigid bodies in 3 dimensions with very high precision and can be used to measure early micromotion of glenoid implants. MATERIALS AND METHODS: Radiostereometric analysis was used to measure migration of 11 partially cemented fluted pegged glenoid components in patients with osteoarthritis who underwent shoulder arthroplasty during a 2-year period. Patients were evaluated using the American Shoulder and Elbow Surgeons (ASES) and Constant scores and by a computed tomography (CT) scan at the 2-year follow-up. RESULTS: Migration patterns could be classified into 2 groups: The first group showed little if any migration, the second group rotated by 4° or more as early as 3 months after operation. The maximum total point motion reached up to 2 mm by the 6-month follow-up. At 12 months, the 2 groups could be identified by the presence or absence of focal lucency around the central peg. At the end of 2 years, CT scans were able to classify the same 2 migration patterns by the presence or absence of osseointegration around the cementless central peg of the glenoid implant. The clinical effect of the absence of osseointegration in this novel glenoid component is unknown because both groups had similar clinical results at 2 years. CONCLUSION: Rapid early migration associated with focal lucency and absence of osseointegration was observed in 6 of 11 components. We postulate that lack of initial fixation leads to early movement of the glenoid component and failure of osseointegration.

Rehabilitation regimens following surgical repair of extensor tendon injuries of the hand-a systematic review of controlled trials.

There is no consensus on the most effective rehabilitation regimen following extensor tendon repair of the hand. This systematic review evaluates the outcomes of the various regimens. The Cochrane, MEDLINE, EMBASE, CINAHL, AMED, PEDro, OTseeker databases were searched for any prospective randomised clinical trials comparing rehabilitation regimens for acute extensor tendon injuries in adults. Five papers met the inclusion criteria. The regimens were static immobilisation, dynamic splinting and early active motion (EAM). There was no standard format of reporting. The sample size ranged from 27 to 100 patients. The duration of follow-up ranged from 8 to 24 weeks. Overall, patients' total active motion improved with time. Early mobilisation regimens (active and passive) achieve quicker recovery of motion than static immobilisation but the long-term outcome appears similar. Given the comparable outcomes between dynamic splinting and EAM, we therefore favour EAM which is simpler and more convenient.

A study of the micromovement of pegged and keeled glenoid components compared using radiostereometric analysis.

In a prospective, randomized study between 2000 and 2004, 20 patients with primary osteoarthritis of the shoulder had a total shoulder arthroplasty with radiostereometric analysis, 10 with keeled and 10 with pegged glenoid components. The relative movement of the glenoid component with respect to the scapula was measured over a 24-month period. Three keeled and five pegged glenoids needed reaming for erosion. The largest translations occurred along the longitudinal axis (mean of 1.35 mm for keeled eroded components) (P = .017 for keeled vs pegged components and P = .013 for eroded vs non-eroded components). Both of the other translation axes showed no significant differences. The highest maximum total point movement at 24 months was 2.57 mm for keeled eroded components and 1.64 mm for pegged eroded components (P = .029 for keeled vs pegged components and P = .023 for eroded vs non-eroded components). The largest rotation was anteversion, with mean values of 5.5 degrees for keeled eroded components and 4.8 degrees for pegged eroded components (P = .658 for keeled vs pegged components and P = .90 for eroded vs non-eroded components). The mean varus tilt was 4.5 degrees for keeled eroded components compared with 2.3 degrees for pegged eroded components (P = .004 for keeled vs pegged components and P = .016 for eroded vs non-eroded components), and finally, anterior-posterior rotation mean values were 3.5 degrees for keeled eroded components and 1.1 degrees for pegged eroded components (P = .022 for keeled vs pegged components and P = .04 for eroded vs non-eroded components). In conclusion, whereas all components moved, radiostereometric analysis revealed increased migration with keeled components, exacerbated by glenoid erosion. Furthermore, a distinctive pattern of migration was identified over the 2-year period.

Long-term outcome of nonsurgically managed Kienböck's disease.

PURPOSE: To analyze the natural history of patients with Kienböck's disease who did not have any surgical treatment-in effect, to map the pattern of the disease process. METHODS: Thirty-three patients (33 wrists) with conservatively treated Kienböck's disease had a full clinical and radiologic review. The review involved an assessment of pain, range of motion, function, grip strength, and patient satisfaction, as well as a detailed radiologic evaluation. RESULTS: Analysis of the results shows reduction in the range of motion of the wrist, particularly flexion, with progression of the disease process. In addition grip strength deteriorated by 40% between stages 2 and 4. The Disabilities of the Arm, Shoulder, and Hand evaluation system also showed deterioration between stages 2 and 4. Radiologic progression was best measured by the radioscaphoid angle. CONCLUSIONS: Kienböck's disease is progressive and does pass through the various stages described by Lichtman. Progression can be monitored clinically by the Disabilities of the Arm, Shoulder, and Hand score and the loss of flexion of the wrist. Radiologic progression is best measured by the radioscaphoid angle.