Is It Time to Rethink the Relationship Between Subscapularis Tears and the Long Head of Biceps Tendon?

Introduction Pre-operative diagnosis of subscapularis tears remains a difficult challenge. Ultrasound has been shown to be ineffective at directly detecting subscapularis tears. It has been widely accepted that medial subluxation of the long head of biceps tendon (LHBT) is associated with full-thickness subscapularis tears. The aims of this study are to assess whether LHBT subluxation on ultrasound scanning has any predictive value for subscapularis tears and to determine the relationship between LHBT subluxation and subscapularis tears at arthroscopy. Methods Pre-operative ultrasound and arthroscopic findings for patients undergoing arthroscopic rotator cuff repair at our institution between March 2011 and January 2016 were analysed. The accuracy of LHBT subluxation on ultrasound and at arthroscopy as a predictor of subscapularis tears at arthroscopy was calculated. The correlation between LHBT subluxation and subscapularis tears was determined. A standardised technique was used for ultrasound scans, and the grade of the sonographer was recorded. Results Three hundred fifty-nine rotator cuff repairs were performed. Twenty-four patients had a subluxed LHBT. Ultrasound was poorly sensitive (50%), and a subluxed LHBT on ultrasound only correlated very weakly with subscapularis tears at arthroscopy (R = 0.268, p<0.001). At arthroscopy, 92 patients had full-thickness subscapularis tears. Of these, only 16 patients (17%) had a subluxed/dislocated LHBT. Of the 24 patients with a subluxed LHBT, eight had no subscapularis tears. Thus, LHBT subluxation/dislocation only correlated weakly with full-thickness subscapularis tears (R=0.252, p<0.001). Conclusion Due to their close anatomical relationship, traditional teaching suggests subscapularis tears are associated with medial LHBT subluxation. Our data indicate that, contrary to popular belief, the two are only weakly correlated. In our series, the majority of patients with subscapularis tears (83%) had their LHBT in-groove. The authors therefore recommend high vigilance during arthroscopy for the diagnosis and repair of subscapularis tears, regardless of pre-operative ultrasound findings and the intra-operative position of the LHBT.

Acute rehabilitation following traumatic anterior shoulder dislocation (ARTISAN): pragmatic, multicentre, randomised controlled trial.

OBJECTIVE: To assess the effects of an additional programme of physiotherapy in adults with a first-time traumatic shoulder dislocation compared with single session of advice, supporting materials, and option to self-refer to physiotherapy. DESIGN: Pragmatic, multicentre, randomised controlled trial (ARTISAN). SETTING AND PARTICIPANTS: Trauma research teams at 41 UK NHS Trust sites screened adults with a first time traumatic anterior shoulder dislocation confirmed radiologically, being managed non-operatively. People were excluded if they presented with both shoulders dislocated, had a neurovascular complication, or were considered for surgical management. INTERVENTIONS: One session of advice, supporting materials, and option to self-refer to physiotherapy (n=240) was assessed against the same advice and supporting materials and an additional programme of physiotherapy (n=242). Analyses were on an intention-to-treat basis with secondary per protocol analyses. MAIN OUTCOME MEASURES: The primary outcome was the Oxford shoulder instability score (a single composite measure of shoulder function), measured six months after treatment allocation. Secondary outcomes included the QuickDASH, EQ-5D-5L, and complications. RESULTS: 482 participants were recruited from 40 sites in the UK. 354 (73%) participants completed the primary outcome score (n=180 allocated to advice only, n=174 allocated to advice and physiotherapy). Participants were mostly male (66%), with a mean age of 45 years. No significant difference was noted between advice compared with advice and a programme of physiotherapy at six months for the primary intention-to-treat adjusted analysis (between group difference favouring physiotherapy 1.5 (95% confidence interval -0.3 to 3.5)) or at earlier three month and six week timepoints. Complication profiles were similar across the two groups (P>0.05). CONCLUSIONS: An additional programme of current physiotherapy is not superior to advice, supporting materials, and the option to self-refer to physiotherapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN63184243.

Assessment of seasonality and normalization techniques for wastewater-based surveillance in Ontario, Canada.

Introduction: Wastewater-based surveillance is at the forefront of monitoring for community prevalence of COVID-19, however, continued uncertainty exists regarding the use of fecal indicators for normalization of the SARS-CoV-2 virus in wastewater. Using three communities in Ontario, sampled from 2021-2023, the seasonality of a viral fecal indicator (pepper mild mottle virus, PMMoV) and the utility of normalization of data to improve correlations with clinical cases was examined. Methods: Wastewater samples from Warden, the Humber Air Management Facility (AMF), and Kitchener were analyzed for SARS-CoV-2, PMMoV, and crAssphage. The seasonality of PMMoV and flow rates were examined and compared by Season-Trend-Loess decomposition analysis. The effects of normalization using PMMoV, crAssphage, and flow rates were analyzed by comparing the correlations to clinical cases by episode date (CBED) during 2021. Results: Seasonal analysis demonstrated that PMMoV had similar trends at Humber AMF and Kitchener with peaks in January and April 2022 and low concentrations (troughs) in the summer months. Warden had similar trends but was more sporadic between the peaks and troughs for PMMoV concentrations. Flow demonstrated similar trends but was not correlated to PMMoV concentrations at Humber AMF and was very weak at Kitchener (r = 0.12). Despite the differences among the sewersheds, unnormalized SARS-CoV-2 (raw N1-N2) concentration in wastewater (n = 99-191) was strongly correlated to the CBED in the communities (r = 0.620-0.854) during 2021. Additionally, normalization with PMMoV did not improve the correlations at Warden and significantly reduced the correlations at Humber AMF and Kitchener. Flow normalization (n = 99-191) at Humber AMF and Kitchener and crAssphage normalization (n = 29-57) correlations at all three sites were not significantly different from raw N1-N2 correlations with CBED. Discussion: Differences in seasonal trends in viral biomarkers caused by differences in sewershed characteristics (flow, input, etc.) may play a role in determining how effective normalization may be for improving correlations (or not). This study highlights the importance of assessing the influence of viral fecal indicators on normalized SARS-CoV-2 or other viruses of concern. Fecal indicators used to normalize the target of interest may help or hinder establishing trends with clinical outcomes of interest in wastewater-based surveillance and needs to be considered carefully across seasons and sites.

Subacromial balloon spacer for irreparable rotator cuff tears of the shoulder (START:REACTS): a group-sequential, double-blind, multicentre randomised controlled trial.

BACKGROUND: New surgical procedures can expose patients to harm and should be carefully evaluated before widespread use. The InSpace balloon (Stryker, USA) is an innovative surgical device used to treat people with rotator cuff tears that cannot be repaired. We aimed to determine the effectiveness of the InSpace balloon for people with irreparable rotator cuff tears. METHODS: We conducted a double-blind, group-sequential, adaptive randomised controlled trial in 24 hospitals in the UK, comparing arthroscopic debridement of the subacromial space with biceps tenotomy (debridement only group) with the same procedure but including insertion of the InSpace balloon (debridement with device group). Participants had an irreparable rotator cuff tear, which had not resolved with conservative treatment, and they had symptoms warranting surgery. Eligibility was confirmed intraoperatively before randomly assigning (1:1) participants to a treatment group using a remote computer system. Participants and assessors were masked to group assignment. Masking was achieved by using identical incisions for both procedures, blinding the operation note, and a consistent rehabilitation programme was offered regardless of group allocation. The primary outcome was the Oxford Shoulder Score at 12 months. Pre-trial simulations using data from early and late timepoints informed stopping boundaries for two interim analyses. The primary analysis was on a modified intention-to-treat basis, adjusted for the planned interim analysis. The trial was registered with ISRCTN, ISRCTN17825590. FINDINGS: Between June 1, 2018, and July 30, 2020, we assessed 385 people for eligibility, of which 317 were eligible. 249 (79%) people consented for inclusion in the study. 117 participants were randomly allocated to a treatment group, 61 participants to the debridement only group and 56 to the debridement with device group. A predefined stopping boundary was met at the first interim analysis and recruitment stopped with 117 participants randomised. 43% of participants were female, 57% were male. We obtained primary outcome data for 114 (97%) participants. The mean Oxford Shoulder Score at 12 months was 34·3 (SD 11·1) in the debridement only group and 30·3 (10·9) in the debridement with device group (mean difference adjusted for adaptive design -4·2 [95% CI -8·2 to -0·26];p=0·037) favouring control. There was no difference in adverse events between the two groups. INTERPRETATION: In an efficient, adaptive trial design, our results favoured the debridement only group. We do not recommend the InSpace balloon for the treatment of irreparable rotator cuff tears. FUNDING: Efficacy and Mechanism Evaluation Programme, a Medical Research Council and National Institute for Health and Care Research partnership.

Development of a single-session physiotherapy and self-management intervention for the treatment of primary traumatic anterior shoulder dislocation for the 'Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN)' multi centre RCT.

OBJECTIVE: Optimum physiotherapy management for people with a conservatively managed primary traumatic anterior shoulder dislocation is not known. The purpose of the ARTISAN trial is to compare the clinical and cost-effectiveness of a course of usual care physiotherapy with a single session of physiotherapy and self-management, the ARTISAN intervention. ARTISAN is a UK multi-centre, two-arm, parallel group, randomised controlled trial with 1:1 treatment allocation. DESIGN: The intervention was developed following the Medical Research Council framework for developing and evaluating complex interventions and will be reported in line with the template for intervention description and replication checklist (TIDieR) and the Consensus on Exercise Reporting Template (CERT). It was informed by published research, national clinical guidelines, current clinical practice and patient and public involvement. RESULTS: The ARTISAN intervention comprises education (Phase 1), progressive exercise (Phase 2 and Phase 3) and an optional return to sport component (Phase 4). Behaviour change strategies are embedded throughout intervention. The single session of physiotherapy is delivered by a chartered physiotherapist, within the first six weeks of injury, in an NHS outpatient setting. At the end of the initial session, paper-based booklets and/or a patient website with the same content are provided to participants to aid self-management and progression though the four phases of the trial intervention. CONCLUSION: The ARTISAN intervention was successfully implemented throughout the internal pilot and is suitable for testing in the subsequent definitive RCT ARTISAN trial. Trial Registration Number ISRCTN63184243.

Shoulder Pain Diagnosis, Treatment and Referral Guidelines for Primary, Community and Intermediate Care.

These care pathway guidelines for the shoulder have been written in collaboration with the NHS Evidence Based Interventions (EBI) programme. The EBI programme is a partnership between the Academy of Medical Royal Colleges, NHS Clinical Commissioners, the National Institute for Health and Care Excellence, as well as NHS England and Improvement.

Proof of Concept: The Use of Whole-Slide Images (WSI) for Peer Review of Tissues on Routine Regulatory Toxicology Studies.

This Proof of Concept (POC) study was to assess whether assessment of whole slide images (WSI) of the 2 target tissues for a contemporaneous peer review can elicit concordant results to the findings generated by the Study Pathologist from the glass slides. Well-focused WSI of liver and spleen from 4 groups of mice, that had previously been diagnosed to be the target tissues by an experienced veterinary toxicologic pathologist examining glass slides, were independently reviewed by 3 veterinary pathologists with varying experience in assessment of WSIs. Diagnostic discrepancies were then reviewed by an experienced adjudicating pathologist. Assessment of microscopic findings using WSI showed concordance with the glass slides, with only slight discrepancy in severity grades noted. None of the lesions recorded by the Study pathologist were "missed" and no lesions were added by the pathologists evaluating WSIs, thus demonstrating equivalence of the WSI to glass slides for this study.

Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) standardized template for collection of key information for benefit-risk assessment of live-attenuated viral vaccines.

Several live-attenuated viral vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of live-attenuated viral vaccines. This will help key stakeholders assess potential safety issues and understand the benefit-risk of such vaccines. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed live-attenuated viral vaccines.

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of inactivated viral vaccines.

Inactivated viral vaccines have long been used in humans for diseases of global health threat and are now among the vaccines for COVID-19 under development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of inactivated viral vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of the vaccine platform. The standardized and structured assessment provided by the template would also help to contribute to improved communication and support public acceptance of licensed inactivated viral vaccines.

The Brighton Collaboration standardized template for collection of key information for benefit-risk assessment of protein vaccines.

Several protein vaccine candidates are among the COVID-19 vaccines in development. The Brighton Collaboration Viral Vector Vaccines Safety Working Group (V3SWG) has prepared a standardized template to describe the key considerations for the benefit-risk assessment of protein vaccines. This will help key stakeholders to assess potential safety issues and understand the benefit-risk of such a vaccine platform. The structured and standardized assessment provided by the template would also help contribute to improved public acceptance and communication of licensed protein vaccines.

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS).

INTRODUCTION: Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials. METHODS AND ANALYSIS: Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media. TRIAL REGISTRATION NUMBER: ISRCTN17825590.

Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN): protocol for a multicentre randomised controlled trial.

INTRODUCTION: First-time traumatic anterior shoulder dislocation (TASD) is predominantly managed non-operatively. People sustaining TASD have ongoing pain, disability and future risk of redislocation. There are no published randomised controlled trials (RCTs) comparing different non-operative rehabilitation strategies to ascertain the optimum clinically effective approach after TASD. METHODS AND ANALYSIS: In this multicentre adaptive RCT, with internal pilot, adults with a radiologically confirmed first time TASD treated non-surgically will be screened at a minimum of 30 sites. People with neurovascular complications, bilateral dislocations or are unable to attend physiotherapy will be excluded.Randomisation will be on a 1:1 treatment allocation, stratified by age, hand dominance and site. Participants will receive a single session of advice; or a single session of advice plus offer of further physiotherapy (maximum 4 months). The primary analysis will be the difference in Oxford Shoulder Instability Score at 6 months. A sample size of a minimum of 478 participants will allow us to show a four point difference with 90% power.An embedded qualitative study will explore the participants' experiences of the trial interventions. ETHICS, REGISTRATION AND DISSEMINATION: Funded by NIHR HTA (16/167/56), 1 June 2018; National Research Ethic Committee approved (18/WA/0236), 26 July 2018. First site opened 5 November 2018 and final results will be updated on trial registries and submitted to a peer-reviewed journal and will inform rehabilitation strategies after a TASD. Study Within A Trial (SWAT) funded by MRC (MR/R013748/1), 1 May 2019; registered on the MRC-HTMR All-Ireland Hub (reference number SWAT 121). TRIAL REGISTRATION NUMBER: ISRCTN63184243. (Trial stage: Pre-results).

The Natural History of Full-Thickness Rotator Cuff Tears in Randomized Controlled Trials: A Systematic Review and Meta-analysis.

BACKGROUND: Rotator cuff tears are the most common tendon injury in the adult population, resulting in substantial morbidity. The optimum management for these patients is not known. PURPOSE: To assess the overall treatment response to all interventions in full-thickness rotator cuff tears among patients enrolled in randomized clinical trials. STUDY DESIGN: Systematic review and meta-analysis. METHODS: Randomized controlled trials (RCTs) were identified from a systematic search of Medline, Embase, CINHAL, and the Cochrane Central Register of Controlled Trials. Patients were aged ≥18 years with a full-thickness rotator cuff tear. The primary outcome measure was change in Constant shoulder score from baseline to 52 weeks. A meta-analysis to assess treatment response was calculated via the standardized mean change in scores. RESULTS: A total of 57 RCTs were included. The pooled standardized mean change as compared with baseline was 1.42 (95% CI, 0.80-2.04) at 3 months, 2.73 (95% CI, 1.06-4.40) at 6 months, and 3.18 (95% CI, 1.64-4.71) at 12 months. Graphic plots of treatment response demonstrated a sustained improvement in outcomes in nonoperative trial arms and all operative subgroup arms. CONCLUSION: Patients with full-thickness rotator cuff tears demonstrated a consistent pattern of improvement in Constant score with nonoperative and operative care. The natural history of patients with rotator cuff tears included in RCTs is to improve over time, whether treated operatively or nonoperatively.

Microvascular blood flow in normal and pathologic rotator cuffs.

BACKGROUND: Microvascular blood flow in the tendon plays an important role in the pathogenesis of rotator cuff abnormalities. There are conflicting views about the presence of a hypovascular zone in the supraspinatus tendon. Besides, no studies have looked at the pattern of blood flow around a partial-thickness tear. Our aim was to measure microvascular blood flow in normal and a range of pathologic rotator cuff tendons using laser doppler flowmetry. METHODS: A total of 120 patients having arthroscopic shoulder surgery were divided into 4 equal groups on the basis of their intraoperative diagnosis: normal rotator cuff, subacromial impingement syndrome, and partial-thickness or full-thickness rotator cuff tear. Microvascular blood flow was measured at 5 different regions of each cuff using a laser doppler probe. The values were compared to assess variability within and between individuals. RESULTS: Total blood flow was greater in the normal rotator cuff group compared with the groups with pathologic rotator cuffs, with the largest difference seen in the subacromial impingement group. Within individuals, blood flow was highest at the musculotendinous junction and lowest at the lateral insertional part of the tendon. Among groups, the blood flow was significantly lower at the anteromedial and posteromedial cuff in the groups with impingement and full-thickness tears compared with the group with normal cuff. CONCLUSION: Real-time in vivo laser doppler analysis has shown that microvascular blood flow is not uniform throughout the supraspinatus tendon. Blood flow in the pathologic supraspinatus tendon was significantly lower compared with the normal tendon.

Mid-term results of Copeland shoulder cementless surface replacement arthroplasty from an independent centre.

BACKGROUND: The present study reports our experience of Copeland shoulder cementless surface replacement arthroplasty (CSRA) and whether glenoid microfracture influences the progression of glenoid erosion. METHODS: One-hundred-and-twelve CSRAs were performed in 101 patients between 2002 and 2007. Eighty-three patients were alive at the median follow-up time of 72 months (range 9 to 121 months; interquartile range 46 to 93 months). Assessment included an Oxford shoulder score (OSS), patient satisfaction score and plain radiographs. RESULTS: The mean (range) OSS was 27 (7 to 48) and 64 of 73 (87.7%) patients were 'very satisfied' or 'satisfied' with their shoulder. Twenty-three (20.5%) shoulders had over 2 mm of glenoid erosion. Microfracture was performed in 43 of 112 shoulders (38.4%) and did not influence the progression of glenoid erosion. Further surgery was performed in 27 (24.1%) shoulders, including 15 revisions, eight arthrolyses and four subacromial decompressions. Revision to total shoulder arthroplasty was performed in 14 : 10 for glenoid erosion; one each for loosening, periprosthetic fracture, deep infection, and chronic pain. One was revised to reverse arthroplasty for chronic pain. CONCLUSIONS: CSRA performed in an independent centre reproduces the functional outcomes reported by the designer. Glenoid erosion, however, was a common occurrence and the main cause of revision - microfracture did not influence its progression.

Accuracy of abduction-external rotation MRA versus standard MRA in the diagnosis of intra-articular shoulder pathology.

The goal of this study was to compare the accuracy of abduction-external rotation magnetic resonance arthrography (ABERMRA) with standard MRA in the diagnosis of intra-articular shoulder pathology.One hundred three consecutive patients undergoing preoperative direct MRA and subsequent arthroscopic examination were included in the study. Seventy-eight patients underwent standard MRA and 25 underwent ABERMRA. Specialist-trained musculoskeletal radiologists reported all scans, and attending shoulder surgeons performed all arthroscopies. Arthroscopic assessment revealed 11 partial-thickness rotator cuff tears, 3 full-thickness tears, 64 labral lesions (48 soft tissue and 16 significant bony), and 17 superior labrum anterior-posterior (SLAP) tears. The sensitivity/specificity for standard MRA was 0.56/0.99 for partial-thickness rotator cuff tears, 1.00/1.00 for full-thickness rotator cuff tears, 0.75/0.91 for soft tissue labral tears, 0.58/1.00 for significant bony glenoid lesions, and 0.50/0.91 for SLAP tears. Abduction-external rotation magnetic resonance arthrography increased the sensitivity/specificity to 1.00/0.85 for soft tissue labral tears, 0.75/1.00 for significant bony glenoid lesions, and 1.00/1.00 for SLAP tears, although it missed 2 of 2 partial-thickness rotator cuff tears.This study suggests that standard MRA is a valuable investigation tool for instability, SLAP tears, and rotator cuff tears, although limitations exist. Additional ABERMRA sequences appear to improve the diagnostic accuracy of soft tissue anterior and posterior labral tears, SLAP tears, and significant bony glenoid lesions and should be routinely requested by shoulder surgeons when ordering MRAs to obtain the maximum benefit from this invasive investigation.

Partial-thickness articular surface rotator cuff tears in patients over the age of 35: Etiology and intra-articular associations.

PURPOSE: Partial-thickness articular-sided rotator cuff tears have a multifactorial etiology and are associated with degeneration of the tendon. They are often described as an injury of the young athlete, although they are also found in the older population. The aim of this study was to investigate the frequency and associations of partial-thickness articular-sided tears in patients over the age of 35 years. DESIGN: Retrospective MATERIALS AND METHODS: A retrospective study of all arthroscopic procedures for rotator cuff pathology in patients over the age of 35 years over a 2-year period by a single surgeon was performed. The included patients were divided into two groups based on the arthroscopic findings: those with a partial-thickness articular-sided rotator cuff tear and those with pure tendinopathy. The groups were then compared to identify the associated pathology with the rotator cuff lesions. 2×2 contingency table analysis and unpaired Student's t-test were used for statistical analysis. RESULTS: One hundred patients were included in the study of whom 62 had a partial articular-sided tear. Those with a partial articular-sided tear were older (P=0.0001), were more commonly associated with a documented injury (P=0.03), and more commonly had biceps degeneration (P=0.001) and synovitis (P=0.02) within the joint. CONCLUSION: Partial-thickness articular-sided tears are a common occurrence in patients requiring arthroscopic surgery for rotator cuff pathology over the age of 35 years. This probably reflects an injury in an already degenerate cuff. This would support the theory of intrinsic degeneration of the tendon in this age group and probably represent a different etiology to those seen in the young athletes. LEVEL OF EVIDENCE: Level 3.

Focal liver lesion detection and characterization with diffusion-weighted MR imaging: comparison with standard breath-hold T2-weighted imaging.

PURPOSE: To retrospectively compare diffusion-weighted (DW) magnetic resonance (MR) imaging with standard breath-hold T2-weighted MR imaging for focal liver lesion (FLL) detection and characterization, by using consensus evaluation and other findings as the reference standard. MATERIALS AND METHODS: Approval for this retrospective HIPAA-compliant study was obtained from the institutional review board; informed consent was waived. Fifty-three consecutive patients (30 men, 23 women; mean age, 60.7 years) with at least one FLL of 1 cm or greater in diameter were evaluated. Two independent observers reviewed DW (b values of 0, 50, and 500 sec/mm(2)) and T2-weighted images for FLL detection and characterization. Reference standard for diagnosis was obtained from consensus review by the two observers of DW, T2-weighted, and dynamic contrast material-enhanced images, pathologic data, and follow-up imaging results. Apparent diffusion coefficient (ADC) was measured for FLLs identified at consensus review. DW and T2-weighted images were compared for FLL detection and characterization by using a binary logistic regression model. Receiver operating characteristic curve analyses were conducted to evaluate the utility of ADC for diagnosis of malignancy. RESULTS: Two hundred eleven FLLs (136 malignant, 75 benign) were detected at consensus review. Overall detection rate (averaged for two observers) was significantly higher for DW (87.7%) versus T2-weighted (70.1%) imaging (P < .001). FLL characterization was not significantly different between DW (89.1%) and T2-weighted (86.8%) imaging (P = .51). ADCs of malignant FLLs were significantly lower than those of benign FLLs (P < .001). The area under the curve for diagnosis of malignancy was 0.839, with sensitivity of 74.2%, specificity of 77.3%, positive predictive value of 85.5%, negative predictive value of 62.3%, and accuracy of 75.3%, by using a threshold ADC of less than 1.60 x 10(-3) mm(2)/sec. CONCLUSION: DW MR imaging was better than standard breath-hold T2-weighted imaging for FLL detection and was equal to breath-hold T2-weighted imaging for FLL characterization.