Health-related quality of life in patients with conditions affecting the hand: meta-analysis.

BACKGROUND: Health state utility values provide the quality component of quality-adjusted life years and are essential for health economic analyses, such as the National Institute for Health and Care Excellence Technology Appraisal. The aims of this systematic review were to: catalogue utility values for health states experienced by patients with hand conditions; provide pooled utility estimates for common hand conditions; and determine how utilities have been estimated. METHODS: A PRISMA-compliant systematic review and meta-analysis was conducted (registered in PROSPERO, the international prospective register of systematic reviews (CRD42021226098)). Five databases were searched from inception until April 2023 (Embase, MEDLINE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Cochrane Central Register of Controlled Trials (CENTRAL)). All studies that reported primary utility values for hand health states in adult patients were eligible for inclusion. Pooled utility estimates were determined across conditions and intervention status using random-effects meta-analysis. RESULTS: A total of 10 254 articles were identified; 57 studies met the full inclusion criteria and reported 363 distinct health state utility values. Health state utility values were estimated using a range of methods; the most common measure was the EQ-5D. Pooled utility estimates for carpal tunnel syndrome and hand osteoarthritis before surgical intervention were 0.69 (95% c.i. 0.66 to 0.73) and 0.63 (95% c.i. 0.60 to 0.67) respectively. CONCLUSION: Pooled utility estimates for patients with untreated carpal tunnel syndrome and hand osteoarthritis are 11% and 18% lower than age-matched population norms respectively. Hand conditions have a significant detrimental impact on health-related quality of life and this study provides catalogued utility values for use in future economic analyses to support the delivery of value-based hand surgery.

Evaluation of Vectra® XT 3D Surface Imaging Technology in Measuring Breast Symmetry and Breast Volume.

BACKGROUND: Breast symmetry is an essential component of breast cosmesis. The Harvard Cosmesis scale is the most widely adopted method of breast symmetry assessment. However, this scale lacks reproducibility and reliability, limiting its application in clinical practice. The VECTRA® XT 3D (VECTRA®) is a novel breast surface imaging system that, when combined with breast contour measuring software (Mirror®), aims to produce a more accurate and reproducible measurement of breast contour to aid operative planning in breast surgery. OBJECTIVES: This study aims to compare the reliability and reproducibility of subjective (Harvard Cosmesis scale) with objective (VECTRA®) symmetry assessment on the same cohort of patients. METHODS: Patients at a tertiary institution had 2D and 3D photographs of their breasts. Seven assessors scored the 2D photographs using the Harvard Cosmesis scale. Two independent assessors used Mirror® software to objectively calculate breast symmetry by analysing 3D images of the breasts. RESULTS: Intra-observer agreement ranged from none to moderate (kappa - 0.005-0.7) amongst the assessors using the Harvard Cosmesis scale. Inter-observer agreement was weak (kappa 0.078-0.454) amongst Harvard scores compared to VECTRA® measurements. Kappa values ranged 0.537-0.674 for intra-observer agreement (p < 0.001) with Root Mean Square (RMS) scores. RMS had a moderate correlation with the Harvard Cosmesis scale (rs = 0.613). Furthermore, absolute volume difference between breasts had poor correlation with RMS (R2 = 0.133). CONCLUSION: VECTRA® and Mirror® software have potential in clinical practice as objectifying breast symmetry, but in the current form, it is not an ideal test. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Risk factors for breast cancer-related lymphedema in patients undergoing 3 years of prospective surveillance with intervention.

BACKGROUND: To evaluate risk factors (treatment-related, comorbidities, and lifestyle) for breast cancer-related lymphedema (BCRL) within the context of a Prospective Surveillance and Early Intervention (PSEI) model of care for subclinical BCRL. METHODS: The parent randomized clinical trial assigned patients newly diagnosed with breast cancer to PSEI with either bioimpedance spectroscopy (BIS) or tape measurement (TM). Surgical, systemic and radiation treatments, comorbidities, and lifestyle factors were recorded. Detection of subclinical BCRL (change from baseline of either BIS L-Dex ≥6.5 or tape volume ≥ 5% and < 10%) triggered an intervention with compression therapy. Volume change from baseline ≥10% indicated progression to chronic lymphedema and need for complex decongestive physiotherapy. In this secondary analysis, multinomial logistic regressions including main and interaction effects of the study group and risk factors were used to test for factor associations with outcomes (no lymphedema, subclinical lymphedema, progression to chronic lymphedema after intervention, progression to chronic lymphedema without intervention). Post hoc tests of significant interaction effects were conducted using Bonferroni-corrected alphas of .008; otherwise, an alpha of .05 was used for statistical significance. RESULTS: The sample (n = 918; TM = 457; BIS = 461) was female with a median age of 58.4 years. Factors associated with BCRL risk included axillary lymph node dissection (ALND) (p < .001), taxane-based chemotherapy (p < .001), regional nodal irradiation (RNI) (p ≤ .001), body mass index >30 (p = .002), and rurality (p = .037). Mastectomy, age, hypertension, diabetes, seroma, smoking, and air travel were not associated with BCRL risk. CONCLUSIONS: Within the context of 3 years of PSEI for subclinical lymphedema, variables of ALND, taxane-based chemotherapy, RNI, body mass index >30, and rurality increased risk.

Impact of the EndoPredict genomic assay on treatment decisions for oestrogen receptor-positive early breast cancer patients: benefits of physician selective testing.

PURPOSE: Genomic tests improve accuracy of risk prediction for early breast cancers but these are expensive. This study evaluated the clinical utility of EndoPredict®, in terms of impact on adjuvant therapy recommendations and identification of parameters to guide selective application. METHODS: Patients with ER-positive, HER2-negative, and early-stage invasive breast cancer were tested with EndoPredict®. Two cohorts were recruited: one consecutively and another at clinical team discretion. Systemic treatment recommendations were recorded before and after EndoPredict® results were revealed to the multidisciplinary team. RESULTS: 233 patients were recruited across five sites: 123 consecutive and 110 at clinical team discretion. In the consecutive cohort 50.6% (62/123) cases were classified high risk of recurrence by EndoPredict®, compared with 62.7% (69/110) in the selective cohort. A change in treatment recommendation was significantly more likely (p < 0.0001) in the selective cohort (43/110, 39.1%) compared to the consecutive group (11/123, 8.9%). The strongest driver of selective recruitment was intermediate grade histology, whilst logistic regression modelling demonstrated that nodal status (p < 0.001), proliferative rate (p = 0.001), and progesterone receptor positivity (p < 0.001) were the strongest discriminators of risk. CONCLUSION: Whilst molecular risk can be predicted by traditional variables in a high proportion of cases, EndoPredict® had a greater impact on treatment decisions in those cases selected for testing at team discretion. This is indicative of the robust ability of the clinical team to identify cases most likely to benefit from testing, underscoring the value of genomic tests in the oncologists' tool kit.

A multi-method assessment of 3D printed micromorphological osteological features.

The evaluation of 3D printed osteological materials has highlighted the difficulties associated with accurately representing fine surface details on printed bones. Moreover, there is an increasing need for reconstructions to be demonstrably accurate and reliable for use in the criminal justice system. The aim of this study was to assess the surface quality of 3D prints (n = 9) that presented with micromorphological alterations from trauma, taphonomy and pathology processes. The archaeological bones were imaged using micro-CT scanning and 3D printed with selective laser sintering (SLS) printing. A multi-method experimental approach subsequently identified: (1) the 3D printed bones to be metrically accurate to within 1.0 mm; (2) good representation of micromorphological surface features overall, albeit with some loss of intricate details, depths, and fine textures that can be important for visual processing; (3) five of the nine 3D printed bones were quantitatively scored as accurate using the visual comparison method; and, (4) low mesh comparison distances (± 0.2 mm) between the original models and the digitised 3D print models. The findings offer empirical data that can be used to underpin 3D printed reconstructions of exhibits for use in courts of law. In addition, an adaptable pathway was presented that can be used to assess 3D print accuracy in future reconstructions.

Implementing a prospective surveillance and early intervention model of care for breast cancer-related lymphedema into clinical practice: application of the RE-AIM framework.

PURPOSE: Chronic lymphedema following breast cancer (BC) affects individuals physically, functionally, psychologically, and financially. Despite national guidelines and evidence-based research supporting a prospective surveillance and early intervention model of care (PSM), bridging the gap between research and clinical practice has been difficult. METHOD: As part of an international randomized controlled trial (RCT), Australian women with BC from four hospitals were recruited, monitored for lymphedema at regular intervals over a 3-year period, and were provided a compression garment if intervention was triggered. The reach, effectiveness, adoption, implementation and maintenance (RE-AIM) evaluation framework was used retrospectively to assess a PSM at the individual and organizational level for those who had completed at least 2-year follow-up (N = 219) in the RCT. RESULTS: The application of the RE-AIM framework retrospectively demonstrated an extensive reach to patients across public and private settings; the effectiveness of prospective surveillance and early intervention was achieved through low progression rates to clinical lymphedema (1.8%), and all hospital sites initially approached adopted the research study. Key implementation strategies necessary for effectiveness of this model of care included education to health professionals and patients, staff acceptability, and development of a referral and care pathway. Maintenance dimensions were evaluated both at the individual level with 92-100% adherence rates for all nonoptional study appointments over the 2-year period, and at the organizational-level, PSM was sustained after recruitment ceased for the research study. CONCLUSION: The PSM for lymphedema in BC can be successfully implemented using the RE-AIM framework applied retrospectively. The implementation of the PSM used in the RCT has assisted in changing clinical practices and improving the quality and effectiveness of the health care system.

Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia: A Longitudinal Study of Implant and Other Related Risk Factors.

BACKGROUND: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an emerging cancer that has been linked to the use of textured devices. The recent increase in number and frequency of cases has led to worldwide regulatory action. OBJECTIVES: The authors aimed to longitudinally study BIA-ALCL in Australia since the index case was first reported in 2007. METHODS: Confirmed historical cases were collected and then prospectively analyzed from October 2015 to May 2019. Clinical and implant exposure data were determined and compared with company sales data for 4 devices to generate implant-specific risk. RESULTS: A total 104 cases of BIA-ALCL were diagnosed in Australia with exposure to 149 unique breast implants. The mean age of patients was 48.2 years (range, 22.4-78.5 years). They had an average time from implantation to diagnosis of 6.8 years. A total 51.7% of implants utilized in this cohort were Allergan Biocell devices. The indication for implant usage was for primary cosmetic augmentation in 70%, post-breast cancer reconstruction in 23%, and following weight loss/pregnancy in 7%. The majority of women presented with early (stage 1) disease (87.5%). The risk for developing BIA-ALCL ranged from 1 in 1947 sales (95% confidence interval = 1199-3406) for Silimed Polyurethane devices to 1 in 36,730 (95% confidence interval = 12,568-178,107) for Siltex imprinted textured devices. CONCLUSIONS: Implants with higher surface area/texture seem to be more associated with BIA-ALCL in Australia. Recent regulatory action to suspend, cancel, or recall some of these higher risk devices is supported by these findings.

A traumatic tale of two cities: does EMS level of care and transportation model affect survival in patients with trauma at level 1 trauma centres in two neighbouring Canadian provinces?

BACKGROUND: Two distinct Emergency Medical Services (EMS) systems exist in Atlantic Canada. Nova Scotia operates an Advanced Emergency Medical System (AEMS) and New Brunswick operates a Basic Emergency Medical System (BEMS). We sought to determine if survival rates differed between the two systems. METHODS: This study examined patients with trauma who were transported directly to a level 1 trauma centre in New Brunswick or Nova Scotia between 1 April 2011 and 31 March 2013. Data were extracted from the respective provincial trauma registries; the lowest common Injury Severity Score (ISS) collected by both registries was ISS≥13. Survival to hospital and survival to discharge or 30 days were the primary endpoints. A separate analysis was performed on severely injured patients. Hypothesis testing was conducted using Fisher's exact test and the Student's t-test. RESULTS: 101 cases met inclusion criteria in New Brunswick and were compared with 251 cases in Nova Scotia. Overall mortality was low with 93% of patients surviving to hospital and 80% of patients surviving to discharge or 30 days. There was no difference in survival to hospital between the AEMS (232/251, 92%) and BEMS (97/101, 96%; OR 1.98, 95% CI 0.66 to 5.99; p=0.34) groups. Furthermore, when comparing patients with more severe injuries (ISS>24) there was no significant difference in survival (71/80, 89% vs 31/33, 94%; OR 1.96, 95% CI 0.40 to 9.63; p=0.50). CONCLUSION: Overall survival to hospital was the same between advanced and basic Canadian EMS systems. As numbers included are low, individual case benefit cannot be excluded.

Understanding forensic expert evaluative evidence: A study of the perception of verbal expressions of the strength of evidence.

Verbal expressions of evidential strength are routinely used when presenting forensic expert evaluative evidence. The degree to which these verbal expressions are interpreted uniformly among different individuals requires further empirical study. This study focussed on groups of individuals with different roles within the criminal justice system and individuals with varying degrees of expertise and knowledge. Three groups of individuals were identified: laypeople, legal professionals and those with some forensic or investigative knowledge. The participants in the study (n=230) were provided with a case summary to which a verbal expression of the strength of evidence was randomly assigned. Participants were subsequently invited to indicate their perception of the strength of the evidence on a scale that was provided. Generally, across the study groups, the trend was one of increased perceived strength of evidence as the intended strength of the verbal expression was increased, with some notable exceptions. In general, there was good concordance between the groups in the way the different expressions were perceived. It was found that participants performed poorly when it came to differentiating between expressions at the 'strong' end of the scale ('strong', 'very strong' and 'extremely strong'). The findings resonate with calls for validated and robust communication frameworks for evaluative opinions. Further empirical research in this area is warranted and that such research can represent an important contribution towards improving the communication and presentation of forensic evidence.

Axillary reverse mapping in patients with breast cancer: Is it oncologically safe?

BACKGROUND: Axillary reverse mapping (ARM) is a technique used to identify the lymphatics draining the arm. The aim of this study was to examine the prevalence and predictors of ARM node metastases in breast cancer patients undergoing an axillary lymph node dissection (ALND). METHODS: A total of 87 patients were enrolled in this study. Patent V Blue dye was injected in the upper arm for ARM node localization. All patients had an ALND with the identified ARM node removed and sent separately for histologic analysis. RESULTS: Of 67 (77%) patients in whom an ARM node was identified, 49 (73%) were negative and 18 (27%) were positive for metastases on final histopathology. Positive ARM node status was significantly associated with advanced axillary disease, and larger primary cancers. Patients requiring a completion ALND due to a positive sentinel lymph node biopsy (SLNB) with non-suspicious ARM nodes during surgery did not have ARM node metastases. CONCLUSIONS: There is a high risk of ARM node involvement, approximately a quarter, in patients with preoperatively known lymph node metastases from breast cancer. However, it may be safe to preserve a clinically non-suspicious ARM node in patients with a positive SLNB who require a completion ALND. J. Surg. Oncol. 2016;113:726-731. © 2016 Wiley Periodicals, Inc.

Recurrent Breast Animation after Conversion from Dual Plane to Prepectoral Breast Implant Placement.

Conversion to a prepectoral implant pocket is considered the definitive treatment for breast animation after implant-based breast reconstruction. Although subtle movement of implants placed in the prepectoral plane may be noted on clinical examination by experienced surgeons, current data demonstrate complete resolution of animation deformity with prepectoral implant placement. We present the case of a middle-aged women who underwent breast implant pocket conversion from dual-plane to prepectoral plane for treatment of animation deformity. Although her postoperative recovery was unremarkable with initial resolution of animation, recurrent implant animation was evident on 3-month follow-up. Recurrent breast animation after conversion from dual-plane to prepectoral implant pocket is highly unusual and unreported in the current literature. Although revision surgery may identify potential causes, larger-scale research on contributing factors will be valuable in developing strategies to prevent recurrent animation after conversion to a prepectoral implant pocket.

Drilling down into ethics: A thematic review of ethical considerations for the creation and use of 3D printed human remains in crime reconstruction.

The existing literature contains some exploration of the ethics concerning human remains in forensic and virtual anthropology. However, previous work has stopped short of interrogating the underlying ethical concepts. The question of how people understand and apply these concepts in practice, and what it means to act ethically, remain underexplored. This thematic review explores the ethical considerations that contribute to the creation and use of 3D printed human remains for forensic purposes. The three main branches of ethical theory are outlined to explore how they may apply to forensic practice. Key themes relating to 3D printing human remains in forensic contexts were explored to better understand the ethics landscape, ethical challenges, and the current guidelines in place. Through this thematic review, nine ethics principles were identified as key principles for guiding best practice: anonymity, autonomy, beneficence, consent, context, justice, non-maleficence, proportionality, and transparency. It is suggested that these principles could be incorporated into adaptable guidelines going forward to support ethical practice. The findings also suggest that holistic ethics cognition training may have value in supporting forensic scientists in ethical decision-making, together with procedural and structural design that may promote best practice and reduce cognitive load.

How to convert a submuscular/dual plane reconstruction to a pre-pectoral pocket implant reconstruction.

A conversion from subpectoral breast reconstruction to pre-pectoral breast reconstruction can help with animation resolution and improved patient satisfaction. We describe the conversion technique involving removal of the existing implant, creating a neo-pre-pectoral pocket and restoring the pectoral muscle to its natural position.

Prospective Surveillance with Compression for Subclinical Lymphedema: Symptoms, Skin, and Quality-of-Life Outcomes.

Background: Patients underwent a compression (sleeve and gauntlet) intervention for subclinical breast cancer-related lymphedema (S-BCRL). Physical, emotional, and quality-of-life (QoL) outcomes were examined. Associations of change in extracellular fluid alone through bioimpedance spectroscopy (BIS) or change in whole-arm volume through tape measure with the outcomes at time of S-BCRL were explored. Methods and Results: We enrolled newly diagnosed nonmetastatic breast cancer patients for surveillance up to 36 months postoperatively. Upon detection of S-BCRL, a 28-day compression intervention was initiated. Data were obtained through physical examination/measurement and self-report instruments: skin examination, Lymphedema Symptom Intensity and Distress Survey-Arm, and Functional Assessment of Cancer Therapy General (FACT-G), Breast (FACT-B), and FACT-B+4. Improvements with intervention were observed in the proportion of patients reporting symptom scores ≥3 in function (Cohen's d = -0.46, p < 0.01), in biobehavioral (Cohen's d = -0.30, p < 0.05), maximum number of skin conditions (Cohen's d = -0.34, p < 0.05. 3), FACT-B (Cohen's d = 0.52, p < 0.01), and FACT-B + four (Cohen's d = -0.42, p < 0.01). At the study endpoint, compared with those who did not progress, chronic breast cancer-related lymphedema (C-BCRL) progressing patients had higher overall symptom scores (p = 0.037), more skin conditions (p = 0.009), and lower total FACT-G and FACT-B scores (p < 0.05). At the time of S-BCRL, detection of greater BIS unit change correlated with higher symptom, skin condition, and QoL values. Greater whole-arm volume change correlated with higher FACT-B+4 scores (all p < 0.05). Conclusions: Prospective surveillance, symptom assessment, and compression intervention promote low progression rates from S-BCRL to C-BCRL and as such reduce symptom burden. This closed study is registered with ClinicalTrials.gov NCT02167659.

The Modified M-plasty Approach to Mastectomy: Avoiding the Lateral Dog-ear.

Postmastectomy "dog-ears" are cosmetically displeasing, can contribute to a poorly fitting bra, and may cause discomfort for patients. They occur most commonly in patients with high body mass index and/or large breasts and can be challenging to manage. To avoid the lateral dog-ear following simple mastectomy, we describe the M-plasty with the addition of a lipodermal flap. We demonstrate that the addition of a lipodermal flap not only flattens the lateral contour of the chest wall but also facilitates a tension-free closure. This helps reduce wound-healing issues in high-risk patients with multiple comorbidities, high body mass index, and large breast size.

An investigation into the accuracy of follow-on GPRS/mobile data CDRs.

This study investigated the accuracy of 3G and 4G follow-on GPRS (General Packet Radio Service)/mobile data CDRs (Call Detail Records) from three UK mobile network operators (EE, Vodafone and Three). Follow-on GPRS/mobile data CDRs are currently considered to be more open to misinterpretation than voice/SMS CDRs as uncertainties exist regarding the correspondence between the timestamp and the Cell ID presented within the CDRs. Consequently, follow-on GPRS/mobile CDRs may be disregarded during criminal investigations, potentially losing valuable intelligence and evidence. To assess the accuracy of follow-on GPRS/mobile data CDRs, connected mode RF (Radio Frequency) surveys were conducted while simultaneously producing follow-on GPRS/mobile data CDRs in a travelling vehicle. This allowed a comparison of the start Cell ID presented in the CDR and the Cell ID that provided coverage to the device at the start time of the CDR to assess the correspondence between the timestamp and the Cell ID presented within the CDRs, and to consider the validity of the terminology used by experts. It was found that individual follow-on GPRS/mobile data CDRs cannot consistently place a device within the coverage area of the start Cell ID at the start time of the CDR. Instead, the results indicate that a terminology which places the device within the coverage area of the start Cell ID 'at or before' the start time of the CDR is appropriate. It is crucial that follow-on GPRS/mobile data CDRs are analysed with this consideration in mind so to interpret the evidence correctly.

Incidental findings on single-photon emission computed tomography/computed tomography (SPECT/CT) lymphoscintigraphy in breast cancer: the proposed Westmead SPECT/CT incidental findings classification.

BACKGROUND: The aim of this study is to determine the prevalence of incidental radiological findings detected on SPECT/CT performed as part of pre-operative lymphoscintigraphy for sentinel lymph node biopsy (SLNB) in patients undergoing breast cancer surgery and development of a modified classification to workup these lesions. METHODS: A retrospective audit was performed of all SPECT/CT performed in combination with lymphoscintigrams in breast cancer patients presenting with clinically node negative axillae and operated on by breast surgeons at the Westmead Breast Cancer Institute over a 12-month period. RESULTS: Four hundred and nineteen patients were included in the study. In 149 patients (35.6%), there was a total of 205 incidental findings. The most common findings were, pulmonary abnormalities (38.5%), abdominal findings (27.8%), thyroid nodules (14.6%), cardiac abnormalities (10.7%) and others (8.3%). Using our proposed Westmead SPECT/CT incidental findings (WSIF) classification, 7.8% were known, 17.6% were major findings, 48.3% were minor findings, 15.1% were minimal findings and 11.2% were equivocal findings. 17.6% (n = 36) underwent further workup and investigation and 3.4% of patients (n = 5) required therapeutic intervention, including chemotherapy for primary lung cancer(n = 1) and surgeries (thoracotomy, n = 1; thyroidectomy, n = 2; colonoscopy, n = 1). 93.8% (n = 393) had at least one SLN mapped, most commonly located in Level 1 of the axilla. CONCLUSION: The incidental findings on SPECT/CT in combination with lymphoscintigraphy is within the range of previous studies (27.3-59.5%). A small proportion of patients required significant major interventions (3.4%). We propose that all incidental findings should be assessed according to our WSIF classification to aid in triaging need for further investigation and management.

A Comparison of Bioimpedance Spectroscopy or Tape Measure Triggered Compression Intervention in Chronic Breast Cancer Lymphedema Prevention.

Background: This study compared rates of progression to chronic breast cancer-related lymphedema (defined as ≥ 10% arm volume change from baseline requiring complex decongestive physiotherapy [CDP]) following an intervention for subclinical lymphedema (S-BCRL) triggered by bioimpedance spectroscopy (BIS) or by tape measurement (TM). Methods and Results: This stratified, randomized, international trial enrolled new breast cancer patients undergoing: mastectomy/partial mastectomy, axillary treatment (dissection, sentinel lymph node biopsy [SLNB] >6 nodes or radiation), radiation therapy (chest wall/breast, supraclavicular fossa), or taxane-based chemotherapy. Following postsurgery eligibility reassessment, centralized, 1:1 randomization to prospective surveillance by BIS or TM occurred. S-BCRL detection triggered a 4-week, 12-hour per day, compression sleeve, and gauntlet intervention. The primary outcome (n = 209), rates of postintervention progression to CDP, was assessed over 3 years. Between June 24, 2014 and September 11, 2018, 1200 patients were enrolled, 963 randomized (BIS n = 482; TM n = 481) and 879 analyzed (BIS n = 442; TM n = 437). Median follow-up was 32.9 months (interquartile range = 22, 35). BIS patients triggered an intervention at a lower rate than TM patients (20.1%, n = 89 vs. 27.5%, n = 120, p = 0.011). Median months to trigger were longer with BIS than TM (9.7; 95% confidence interval [CI], 8.2-12.6 vs. 3.9; 95% CI, 2.8-4.5, p = 0.001). Overall, 14.4% (n = 30) progressed post-intervention, with reduced likelihood for BIS patients than TM patients (7.9%, n = 7 vs. 19.2%, n = 23; relative risk = 0.41; 95% CI, 0.13-0.81; absolute reduction 11.3%; 95% CI, 2.3-20.3; p = 0.016). Conclusions: Compared to TM, BIS provides a more precise identification of patients likely to benefit from an early compression intervention. Clinical Trial Registration number: NCT02167659.