A single‐arm trial indirect comparison investigation: a proof‐of‐concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control

To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof‐of‐concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score‐matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi‐layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow‐up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan–Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ² 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non‐healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison.     

Non‐adherence to treatment of chronic wounds: patient versus professional perspectives

The reasons for the non‐adherence to treatment for wound healing are complex and fall into unintentional and intentional categories. This study explored intentional and unintentional non‐adherence to treatment from patient/carer and health care professional perspectives. Patients with wounds receiving ALLEVYN Life dressings (n = 20) and patients not receiving ALLEVYN Life dressings who were deemed to be non‐adherent to treatment regimes (n = 6) took part in semi‐structured interviews to explore their experiences of living with a wound, treatment and intentional and unintentional non‐adherence. Three focus groups of health care professionals explored issues surrounding non‐adherence to treatment regimes. Groups included nurses and doctors (n = 25). We found that relationships between participants and health care professionals varied in character across the groups. All participants expressed reasons for both intentional and unintentional adherence. Many reasons for intentional non‐adherence are related to comfort and working the regime around patients' lives. Health care professionals considered the most common form of non‐adherence to be unintentional. However, patients describe the most common form of non‐adherence as being intentional. The relationship between patients and health care professionals varied in character between the groups. Discrepancies between professional and patient perspectives need to be reconciled and addressed to improve adherence to treatment regimes.     

Anterior Lumbar Interbody Fusion in Left‐sided Inferior Vena Cava and Right‐sided Aortic Arch

Spinal fusion via anterior lumbar interbody fusion (ALIF) can offer symptomatic relief to patients that suffer severe low back pain, radiculopathy, and claudication. However, a detailed working knowledge of the thoracic, abdominal, and lumbar anatomy, particularly of the vasculature, is vital. We report the case of a 68‐year‐old man who presented with radiculopathy and progressively worsening low back pain despite 9 months of unsuccessful conservative therapy and pain management. Preoperative computed tomography and magnetic resonance imaging revealed a rare anatomical variation, with an anomalous left‐sided inferior vena cava and anomalous aorta. The patient was surgically treated with ALIF at L_4,5 and L₅S₁ via an altered surgical window. Given the anomalous anatomy of the patient, instead of performing the procedure after mobilizing both of the transposed abdominal great vessels, the inferior vena cava and the abdominal aorta, the ALIF was uneventfully performed in the window between these vessels. There were no perioperative or postoperative complications. At 12‐week postoperative follow‐up, X‐ray imaging demonstrated successful implantation of ALIF cages with no recurrence of symptoms. A detailed working knowledge of anatomy is important, particularly if anatomical variations are present. This has implications for preoperative surgical planning, which is integral to the safety and the success of procedures.     

Patient Compliance in the Setting of BI‐RADS Category 3: What Factors Impact Compliance With Short‐Term Follow‐Up Recommendations?

The study aims to define how imaging findings, patient demographics, patient–provider interactions, and health care practices may affect a woman's decision to follow‐up in the setting of a BI‐RADS Category 3. A total of 398 women from the University of Arizona Breast Imaging Center with a BI‐RADS Category 3 assessment for mammography and/or ultrasound findings were evaluated between February 2012 and June 2014. Demographic information was analyzed for all patients, regardless of follow‐up. Women who returned for follow‐up within the recommended time period were given one survey at the time of their follow‐up appointment, and women who returned for follow‐up, but later than recommended, were given a separate survey to complete. Age, palpability of a lesion, and menopause status were related to follow‐up. Self‐rated general health was the only factor found to be associated with the decision to follow‐up on time. The majority of patients who followed up on time reported that mailed reminder cards were the primary practice that prompted follow‐up. Of patients who followed up later than recommended, the major reason was “no time.” The findings suggest that additional counseling regarding the benefits of short‐interval imaging follow‐up might be advantageous for patients.     

Prioritizing Patient‐Reported Outcomes in Breast Cancer Surgery Quality Improvement

Breast‐cancer‐specific tools that measure health‐related quality of life (HRQOL) were developed for use in research or clinical practice, and little is known about these tools’ performance ability for quality improvement. Furthermore, existing tools may not fully reflect all issues that contribute to quality care as seen by patients. Work is needed to identify and validate patient‐reported outcome measures for use in quality improvement in breast cancer surgical care. We conducted an exploratory qualitative study in order to better understand what HRQOL domains and processes of care define high quality surgical care for women undergoing mastectomy for breast cancer from both the patient and clinician perspective. We conducted focus groups and one‐on‐one interviews with 15 women and administered a prioritization questionnaire to participants. We also conducted a prioritization questionnaire among surgical oncologists, general surgeons, and reconstructive surgeons who are members of the Washington State Medical Association. Both the patient and surgeon prioritization questionnaire asked participants to prioritize HRQOL and treatment satisfaction‐related aspects of their breast cancer surgical care at key time points before and after mastectomy. A Stakeholder Advisory Panel was convened to review focus group, interview, and prioritization questionnaire results and make recommendations as to patient‐reported outcome domains to focus on and existing instruments to use for quality improvement. Patients and clinicians largely agreed on important HRQOL domains, including emotional well‐being, education, communication, and process of care. The Stakeholder Advisory Panel, composed of 12 clinicians and five patients, reviewed study findings and existing patient‐reported outcomes measurement tools. The panel recommended that the BREAST‐Q, a flexible tool with independently validated modules designed for research and clinical care, is an ideal tool to begin developing novel quality improvement benchmarks focused on patient‐reported outcomes.     

Cardiovascular Health among Black and White Breast Cancer Patients Initiating Aromatase Inhibitor Therapy

The purpose of this study was to compare the cardiovascular health of Black and White breast cancer patients undergoing adjuvant treatment. Baseline data from a cohort study of Black (n = 45) and White (n = 101) breast cancer patients initiating aromatase inhibitor treatment were analyzed. Participants had a cardiovascular health assessment, including carotid intimal medial thickness measurement, donated a blood sample, and completed a questionnaire. Atherosclerotic cardiovascular disease (ASCVD) event risk scores were calculated. Compared to their White counterparts, the Black patients had a significantly higher median ASCVD risk score (p = 0.009) and had a higher number of CVD risk factors (p < 0.05). Black patients were also more likely to have hypertension, diabetes, or to be obese than the White participants. The prevalence of cardiovascular disease and cardiovascular disease risk factors among Black and White breast cancer patients is high, and racial disparities exist which may have treatment implications.     

Apocrine Metaplasia Found at MR Biopsy: Is There Something to be Learned?

The purpose of this study was to determine (a) the frequency of apocrine metaplasia (ApoM) found on MR core biopsy of suspicious findings, and (b) to determine if there are specific MR imaging features that might obviate the need for biopsy. This HIPAA‐compliant retrospective study was performed under IRB exemption for quality assurance studies. Patient demographics, MR imaging features, and pathology were reviewed. Breast lesions which underwent MR‐guided biopsy, yielding ApoM on pathology analysis were included. Retrospective review of MR imaging features of these lesions was performed by two radiologists blinded to pathology results except for the presence of ApoM. Imaging features on MR assessed included location, size, morphology, T1 and T2 signals, and enhancement kinetics. Full pathology results were subsequently reviewed during data analysis. The pathology slides and imaging was subsequently reviewed by two fellowship trained radiologists and a breast pathologist to categorize the finding of ApoM into target lesion (imaging corresponds to size of lesion on pathology) versus incidental lesion. Target lesion characteristics were assessed to determine specific MRI features of ApoM. Between January 2011 to November 2012, 155 distinct breast lesions suspicious for malignancy successfully underwent MR‐guided biopsy. Of the 155 lesions biopsied, 123 (79%) were benign and 32 (21%) were malignant. Of the 123 benign biopsies, ApoM was found in 57 (46%), of which 35 (61%) had no associated atypia and 22 (39%) had associated atypia. Of the 32 malignant biopsies, three (9%) had associated ApoM (DCIS in two cases and DCIS/LCIS in one case). Of the 60 cases with ApoM, only 11 (18.3%) were target lesions and 49 were incidental lesions (81.7%). Of the 60 cases with ApoM, 35 (58%) were masses (average size 0.8 cm for both with or without atypia) and 25 (42%) were nonmass enhancement (NME) (average size 2.1 cm with and 1.0 cm without atypia). Only five (14%) of 35 masses demonstrated spiculated margins, of which four were associated with atypia (80%). Of 22 lesions with atypia or other high‐risk lesion, 14 (64%) were masses, most commonly with irregular margins (64%). Of the 12 T2 hyperintense lesions, only two (1.7)% had associated atypia or high‐risk lesion, and none were associated with malignancy. Of the 11 target lesions, seven were T2 hyperintense. Enhancement kinetics were variable: 30 (50%) showed mixed persistent and plateau kinetics, eight (13%) persistent delayed enhancement, 10 (17%) plateau kinetics, four (7%) washout kinetics, and eight (13%) were below threshold for kinetic analysis. ApoM is a common benign pathologic result at MR‐guided core biopsy for both masses and NME accounting for 39% of all biopsy results in this series. Although there is considerable variability in imaging characteristics on MR, our results suggest biopsy may be safely obviated for lesions that are subcentimeter T2 hyperintense areas of NME and short term follow‐up imaging may be a reasonable alternative for these lesions.     

Five‐year follow‐up after live donor nephrectomy – cross‐sectional and longitudinal analysis of a prospective cohort within the era of extended donor eligibility criteria

To establish the outcome of live kidney donors 5 years after donation, we investigated the risk for progressive renal function decline and quality of life (QoL). Data on estimated glomerular filtration rate (eGFR), creatinine, hypertension, QoL and survival were assessed in a prospective cohort of 190 donors, who donated between 2008 and 2010. Data were available for >90%. The mean age predonation was 52.8 ± 11.5 years, 30 donors having pre‐existent hypertension. The mean follow‐up was 5.1 ± 0.9 years. Eight donors had died due to non‐donation‐related causes. After 5 years, the mean eGFR was 60.2 (95% CI 58.7–62.7) ml/min/1.73 m², with a median serum creatinine of 105.1 (95% CI 102.5–107.8) μmol/l. eGFR decreased to 33.6% and was longitudinally lower among men than women and declining with age (P < 0.001), without any association on QoL. Donors with pre‐existent and new‐onset hypertension demonstrated no progressive decline of renal function overtime compared to nonhypertensives. No donors were found with proteinuria, microalbuminuria or at risk for end‐stage renal disease. After an initial decline postdonation, renal function remained unchanged overtime. Men and ageing seem to affect renal function overtime, while decreased renal function did not affect QoL. These data support further stimulation of living kidney donation programmes as seen from the perspective of donor safety.     

High alcohol intake in deceased donors has no effect on pancreas graft survival: a registry analysis

Outcomes of pancreas transplantation from donors with high alcohol consumption are poorly described. The UK Transplant Registry was used to determine whether donor alcohol intake influenced pancreas survival in simultaneous pancreas–kidney (SPK) transplants performed between 2006 and 2012 (n = 770). Recipients were stratified by donor alcohol intake: group I (n = 122)—high recent alcohol intake (>21 or >14 units of alcohol/week in males or females, respectively) or previous alcohol abuse and group II (n = 648)—low/unknown current intake and no previous alcohol abuse. Median current alcohol intake was higher in group I than group II: 36.3 vs. 10 units/week; P < 0.001. One‐ and five‐year pancreas graft survivals were 88.5% and 73.6% in group I, and 87% and 74.9% in group II. There was no difference in unadjusted graft survival between groups I and II (P = 0.76), and no difference between group II and a subgroup of group I with a donor history of alcohol abuse and high current intake (P = 0.26), or from donors with current alcohol consumption of >50 units/week (P = 0.41). Pancreas donors with past alcohol abuse or current high intake are common, and graft outcomes appear to be acceptable. This analysis suggests that high donor alcohol intake, by itself, should not exclude consideration of pancreas transplantation.     

C1q binding is not an independent risk factor for kidney allograft loss after an acute antibody‐mediated rejection episode: a retrospective cohort study

After kidney transplantation, C4d is an incomplete marker of acute antibody‐mediated rejection (AMR) and C1q‐binding donor‐specific antibodies (DSA) have been associated with allograft survival. However, the impact on allograft survival of C1q+ DSA after clinical AMR has not been studied yet. We analysed retrospectively in clinical AMR C4d staining and C1q‐binding impact on allograft survival. We compared clinical, histological and serological features of C4d− and C4d+ AMR, C1q+ and C1q− DSA AMR and analysed C4d and C1q‐binding impact on allograft survival. Among 500 for‐cause kidney allograft biopsies, 48 fulfilled AMR criteria. C4d+ AMR [N = 18 (37.5%)] have significantly higher number class I DSA (P = 0.02), higher microvascular score (P = 0.02) and more transplant glomerulopathy (P = 0.04). C1q+ AMR [N = 20 (44%)] presented with significantly more class I and class II DSA (P = 0.005 and 0.04) and C4d+ staining (P = 0.01). Graft losses were significantly higher in the C4d+ group (P = 0.04) but similar in C1q groups. C4d+ but not C1q+ binding was an independent risk factor for graft loss [HR = 2.65; (1.11–6.34); P = 0.028]. In our cohort of clinical AMR, C4d+ staining but not C1q+ binding is an independent risk factor for graft loss. Allograft loss and patient survival were similar in C1q+ and C1q− AMR.