Health-related quality of life assessment in health economic analyses involving type 2 diabetes.

AIM: Incorporating health-related quality of life (HRQoL) measures into health economic analyses can help to provide evidence to inform decisions about how to improve patient outcomes in the most cost-effective manner. The aim of this narrative review was to assess which HRQoL instruments have been used in economic evaluations of type 2 diabetes management including in Indigenous communities. METHOD: MEDLINE (Ovid), Embase (Ovid) and Cochrane were searched from inception to June 2022. Studies included patients with type 2 diabetes; economic evaluations, derived scores from direct questioning of individuals; and were in English. Records were assessed for bias using the JBI critical appraisal tools. RESULTS: A total of 3737 records were identified, with 22 publications meeting the criteria for inclusion. Across those 22 articles, nine HRQoL instruments had been utilised. Generic tools were most frequently used to measure HRQoL, including EQ-5D (-3 L and -5 L) (n = 10, 38%); SF-12 (n = 5, 19%); and SF-36 (n = 4, 15%). Two tools addressing the specific stressors faced by people with type 2 diabetes were utilised: Problem Areas In Diabetes tool (n = 1, 4%) and Diabetes Distress Scale (n = 1, 4%). Two publications reported whether the study population included Indigenous peoples. CONCLUSION: A wide range of HRQoL instruments are used in economic evaluations of type 2 diabetes management, with the most frequent being varying forms of the EQ-5D. Few economic evaluations noted whether Indigenous peoples were featured in the study population. More research into HRQoL in people living with type 2 diabetes is urgently needed to improve evidence on effectiveness and cost-effectiveness of interventions.

Transition between paediatric and adult diabetes healthcare services: An online global survey of healthcare professionals' experiences and perceptions.

INTRODUCTION: Youth with diabetes should transition from paediatric to adult diabetes services in a deliberate, organized and cooperative way. We sought to identify healthcare professionals' (HCPs) experiences and perceptions around transition readiness planning, policies and procedures, and the actual transfer to adult services. METHODS: Data were collected via an online global survey (seven language options), broadly advertised by the International Society for Pediatric and Adolescent Diabetes (ISPAD), European Association for the Study of Diabetes (EASD), team members and partners, via newsletters, websites, e-mails and social media. RESULTS: Respondents (n = 372) were mainly physicians (74.5 %), practicing in government funded (59.4 %), paediatric (54.0 %), metropolitan settings (85.8 %) in Europe (44.9 %); 37.1 % in low and middle-income countries (LMICs). Few centers used a transition readiness checklist (32.8 %), provided written transition information (29.6 %), or had a dedicated staff member (23.7 %). Similarly, few involved a psychologist (25.8 %), had combined (35.2 %) or transition/young person-only clinics (34.9 %), or a structured transition education program (22.6 %); 49.8 % advised youth to use technology to assist the transfer. Most (91.9 %) respondents reported barriers in offering a good transition experience. Proportionally, more respondents from LMICs prioritised more funding (p = 0.01), a structured protocol (p < 0.001) and education (p < 0.001). CONCLUSION: HCPs' experiences and perceptions related to transition vary widely. There is a pressing need for an international consensus transition guideline.

Beyond Glucose Monitoring: Multianalyte Sensor Use in Diabetes.

The incidence, prevalence, mortality, and health expenditure associated with diabetes continue to grow, despite efforts. The use of multianalyte sensors, which detect glucose as well as key analytes such as ketones, lactate, insulin, uric acid, and electrolytes, may provide additional information to guide earlier identification and management of diabetes and its complications. We undertook a narrative review using a systematic approach in May 2023, with a bridge search undertaken in April 2024. Four biomedical databases were searched: MEDLINE (Ovid), Embase, Emcare, and Cochrane Library. Searches for gray literature were conducted on ClinicalTrials.gov, Google Scholar, and websites of relevant organizations. Included studies incorporated articles on multianalyte sensors in diabetes and single-analyte sensors proposing integration into multianalyte diabetes management, with no limits placed on publication date and study design. Data were screened and extracted using CovidenceTM software. Overall, 11 articles were included, of which 7 involved multianalyte sensors (involving glucose and other analytes) and 4 single-analyte sensors (measuring non-glucose substances for proposed future integration into multianalyte systems). Analytes examined were ketones (n = 3), lactate (n = 4), uric acid (n = 3), insulin (n = 1), and potassium (n = 1). Results demonstrated that in vitro and in vivo measurements of multi- and single-analyte sensors accurately and reliably corresponded with human capillary and serum samples. While the literature on this topic is sparse, our review demonstrated that measurement of glucose and other analytes can be feasibly undertaken using multi- and single-analyte sensors. More studies in humans are needed to establish clinical utility in diabetes self-management and assist with technological improvements.

Modifiable factors to prevent severe hypoglycaemic and diabetic ketoacidosis presentations in people with type 1 diabetes.

AIMS: In tackling rising diabetes-related emergencies, the need to understand and address emergency service usage by people with type 1 diabetes is vital. This review aimed to quantify current trends in presentations for type 1 diabetes-related emergencies and identify public health strategies that reduce the frequency of diabetes-related emergencies and improve glycaemic management. METHODS: Medline (OVID), Cochrane and CINAHL were searched for studies published between 2000 and 2023, focusing on people with type 1 diabetes, severe hypoglycaemia and/or diabetic ketoacidosis, and ambulance and/or emergency department usage. There were 1313 papers identified, with 37 publications meeting review criteria. RESULTS: The incidence of type 1 diabetes-related emergencies varied from 2.4 to 14.6% over one year for hypoglycaemic episodes, and between 0.07 and 11.8 events per 100 person-years for hyperglycaemic episodes. Notably, our findings revealed that ongoing diabetes education and the integration of diabetes technology, such as continuous glucose monitoring and insulin pump therapy, significantly reduced the incidence of these emergencies. However, socio-economic disparities posed barriers to accessing these technologies, subsequently shifting the cost to emergency healthcare and highlighting the need for governments to consider subsidising these technologies as part of preventative measures. CONCLUSIONS: Improving access to continuous glucose monitoring and insulin pump therapy, in combination with ongoing diabetes education focusing on symptom recognition and early management, will reduce the incidence of diabetes-related emergencies. Concurrent research assessing emergency healthcare usage patterns during the implementation of such measures is essential to ensure these are cost-effective.

Service use and glycaemic control of young people with type 1 diabetes transitioning from paediatric to adult care: a 5-year study.

BACKGROUND: Regular contact with specialist care has been linked to better diabetes outcomes for young people with type 1 diabetes (YPwT1D), but evidence is limited to population-based service usage and outcomes. AIMS: This observational 5-year study sought to capture YPwT1D living in the study catchment area (covering metropolitan, regional and rural Australia) as they transitioned to adult-based diabetes healthcare services and to describe their glycaemic control and complication rates, service usage and associated factors. METHODS: Records between 2010 and 2014 in a public healthcare specialist diabetes database were extracted, care processes and outcomes were described, and associations were sought between episodes of care (EOC) and potentially predictive variables. RESULTS: Annual cohort numbers increased yearly, but without significant differences in demographic characteristics. Each year around 40% had no reported planned specialist care, and the average number of planned EOC decreased significantly year on year. Overall, mean HbA1c levels also reduced significantly, but with higher values recorded for those living in non-metropolitan than metropolitan areas (achieving significance in 3 out of 5 years). Diabetes complication assessments were only reported in 37-46%, indicating one in five with retinopathy and hypertension affecting one in three to five young people. CONCLUSIONS: Findings highlight the importance of investment to address the specific needs of adolescents and young adults and demonstrate the need for better support during these vulnerable early years, particularly for non-metropolitan residents. This will entail changes to funding mechanisms, the health workforce and infrastructure, and new models of care to provide equity of access and quality of specialist care.

Travel health practices, behaviours and experiences of people living with type 1 diabetes.

INTRODUCTION: There are limited data regarding the international travel history and preparation, as well as glycaemic control practices, risk behaviours and experiences of people with type 1 diabetes during travel. Our review aimed to address the research question: 'What are the health practices, behaviours and experiences of people with type 1 diabetes when travelling?' METHODS: We conducted a mixed-methods narrative review using adapted review methods from the Centre for Reviews and Dissemination and standards developed by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. MEDLINE, Scopus, PubMed and CINAHL, and the reference lists of all eligible studies were searched. RESULTS: Nine records comprising of 11 studies were included, with data heralding from various countries, published between 1990 and 2022. We identified three main themes: travel preparation (type of travel, planning and advice seeking); issues related to air travel (airports and airport security, hypoglycaemia and hyperglycaemia, and insulin) and general travel-related issues (illness and medical treatment, type 1 diabetes management, and major concerns and barriers). CONCLUSIONS: Our findings highlighted the lack of quality data regarding type 1 diabetes and travel within the extant literature, as well a pressing need for empirical studies to be undertaken and consensus guidelines developed to improve the travel experiences of people with type 1 diabetes. Unless change is made, people with type 1 diabetes will continue to experience preventable risk and harm while travelling.

Demographic, Clinical, Management, and Outcome Characteristics of 8,004 Young Children With Type 1 Diabetes.

OBJECTIVE: To compare demographic, clinical, and therapeutic characteristics of children with type 1 diabetes age <6 years across three international registries: Diabetes Prospective Follow-Up Registry (DPV; Europe), T1D Exchange Quality Improvement Network (T1DX-QI; U.S.), and Australasian Diabetes Data Network (ADDN; Australasia). RESEARCH DESIGN AND METHODS: An analysis was conducted comparing 2019-2021 prospective registry data from 8,004 children. RESULTS: Mean ± SD ages at diabetes diagnosis were 3.2 ± 1.4 (DPV and ADDN) and 3.7 ± 1.8 years (T1DX-QI). Mean ± SD diabetes durations were 1.4 ± 1.3 (DPV), 1.4 ± 1.6 (T1DX-QI), and 1.5 ± 1.3 years (ADDN). BMI z scores were in the overweight range in 36.2% (DPV), 41.8% (T1DX-QI), and 50.0% (ADDN) of participants. Mean ± SD HbA1c varied among registries: DPV 7.3 ± 0.9% (56 ± 10 mmol/mol), T1DX-QI 8.0 ± 1.4% (64 ± 16 mmol/mol), and ADDN 7.7 ± 1.2% (61 ± 13 mmol/mol). Overall, 37.5% of children achieved the target HbA1c of <7.0% (53 mmol/mol): 43.6% in DPV, 25.5% in T1DX-QI, and 27.5% in ADDN. Use of diabetes technologies such as insulin pump (DPV 86.6%, T1DX 46.6%, and ADDN 39.2%) and continuous glucose monitoring (CGM; DPV 85.1%, T1DX-QI 57.6%, and ADDN 70.5%) varied among registries. Use of hybrid closed-loop (HCL) systems was uncommon (from 0.5% [ADDN] to 6.9% [DPV]). CONCLUSIONS: Across three major registries, more than half of children age <6 years did not achieve the target HbA1c of <7.0% (53 mmol/mol). CGM was used by most participants, whereas insulin pump use varied across registries, and HCL system use was rare. The differences seen in glycemia and use of diabetes technologies among registries require further investigation to determine potential contributing factors and areas to target to improve the care of this vulnerable group.

Coexisiting type 1 diabetes and celiac disease is associated with lower Hba1c when compared to type 1 diabetes alone: data from the Australasian Diabetes Data Network (ADDN) registry.

AIM: To compare HbA1c and clinical outcomes in adolescents and young adults with type 1 diabetes (T1D), with or without celiac disease (CD). METHODS: Longitudinal data were extracted from ADDN, a prospective clinical diabetes registry. Inclusion criteria were T1D (with or without CD), ≥ 1 HbA1c measurement, age 16-25 years and diabetes duration ≥ 1 year at last measurement. Multivariable Generalised Estimated Equation models were used for longitudinal analysis of variables associated with HbA1c. RESULTS: Across all measurements, those with coexisting T1D and CD had lower HbA1c when compared to those with T1D alone (8.5 ± 1.5% (69.4 ± 16.8 mmol/mol) vs. 8.7 ± 1.8% (71.4 ± 19.8 mmol/mol); p < 0.001); lower HbA1c was associated with shorter diabetes duration (B = - 0.06; 95% CI - 0.07 to - 0.05; p < 0.001), male sex (B = - 0.24; - 0.36 to - 0.11; p < 0.001), insulin pump therapy use (B = - 0.46; - 0.58 to - 0.34; p < 0.001), coexistence of T1D and CD (B = - 0.28; - 0.48 to - 0.07; p = 0.01), blood pressure (B = - 0.16; - 0.23 to - 0.09; p < 0.001) and body mass index (B = -- 0.03; - 0.02 to - 0.04; p = 0.01) in the normal range. At last measurement, 11.7% of the total population had a HbA1c < 7.0% (53.0 mmol/mol). CONCLUSIONS: Across all measurements, coexisting T1D and CD is associated with lower HbA1c when compared to T1D alone. However, HbA1c is above target in both groups.

Measurement Analysis of Ice Ball Size during CT-Guided Cryoablation Procedures for Better Prediction of Final Ice Ball Size and Avoidance of Complications.

Introduction Cryoablation is the destruction of living tissue by the application of extreme freezing temperature. There has been an increase in the use of cryoablation in the management of musculoskeletal lesions, in particular fibromatosis. Aim This study aimed to measure the average and relative increase in size of the cryoablation ice ball after the first (10 minutes) and second freeze cycles (20 minutes) to accurately predict the size of the ice ball between first and second freezes to help prevent any unwanted damage of the nearby skin and neurovascular structures. This is especially important when ablating in relatively small body parts such as in the appendicular skeleton. Material and Methods Eight patients treated with cryoablation over a 12-month period for fibromatosis were, included in the study. The size and volume of the ice ball were measured during the first and second cycle of cryoablation. Results The average patient age of the cohort was 35.6 years old (min 28 and max 43). There was female predominance in the study (3:2, F:M). There was a significant increase (26%) in the linear dimensions and almost doubling in the volume of the ice ball between freeze cycles ( p -value = 0.0037 for dimensions and p -value = 0.0002 for volumes). Conclusion This pilot study is a preliminary attempt to predict the eventual size of the ice ball during cryoablation procedures when treating cases of fibromatosis. This should help in planning cryoablation to ensure decrease morbidity by preventing injury to adjacent critical structures (neurovascular bundle and skin).

Type 1 diabetes patient experiences and management practices during the COVID-19 pandemic in rural Uganda.

Background: The COVID-19 pandemic has impacted various aspects of the lives of persons with chronic diseases, including type 1 diabetes (T1D). However, the diabetes care experiences and practices adopted by persons living with T1D after the declaration of the COVID-19 pandemic in Uganda have not been well documented. Objectives: We investigated diabetes management practices and experiences of persons with T1D during the COVID-19 pandemic lockdown in a rural district of southwestern Uganda. Methods: Using interactive sequential explanatory mixed methods, we conducted a cross-sectional study of persons with T1D aged 18-25 years, their caregivers and health workers. Quantitative data was exclusively collected from patients with T1D using Kobo Toolbox™ and analysed with SPSS™ version 26; qualitative interviews were used to elicit responses from purposively selected patients with T1D, plus caregivers and health workers that were analysed using a thematic framework approach. Results: The study enrolled 51 (24 males) patients with T1D; diabetes duration (mean ± SD) 6.6 ± 5 years. Access to insulin syringes significantly worsened in 19.6% of participants (p = 0.03). Insulin injection frequency (p = 0.01), blood glucose monitoring (p = 0.001) and meal frequency (p = 0.0001) significantly decreased. Qualitative interviews highlighted COVID-19 restriction measures had reduced household income, frequency of clinic visits, and access to food, diabetes support and social services. Conclusions: Experiences and practices were consistent with decisions to prioritise survival, even with known risks around metabolic control. Supplementary Information: The online version contains supplementary material available at 10.1007/s40200-023-01222-4.

Primary Benign Neoplasms of the Spine.

Benign tumours comprise the majority of primary vertebral tumours, and these are often found incidentally on imaging. Nonetheless, accurate diagnosis of these benign lesions is crucial, in order to avoid misdiagnosis as more ominous malignant lesions or infection. Furthermore, some of these tumours, despite their benign nature, can have localised effects on the spine including neural compromise, or can be locally aggressive, thus necessitating active management. Haemangiomas and osteomas (enostosis) are the commonest benign tumours encountered. Others include osteoid osteoma, osteoblastoma, fibrous dysplasia, osteochondroma, chondroblastoma, haemangioma, simple bone cysts, aneurysmal bone cysts, giant cell tumours, eosinophilic granuloma and notochordal rests. The majority of lesions are asymptomatic; however, locally aggressive lesions (such as aneurysmal bone cysts or giant cell tumours) can present with nonspecific symptoms, such as back pain, neurological deficits and spinal instability, which may be indistinguishable from more commonly encountered mechanical back pain or malignant lesions including metastases. Hence, imaging, including radiography, computed tomography (CT) and magnetic resonance imaging (MRI), plays a critical role in diagnosis. Generally, most incidental or asymptomatic regions are conservatively managed or may not require any follow-up, while symptomatic or locally aggressive lesions warrant active interventions, which include surgical resection or percutaneous treatment techniques. Due to advances in interventional radiology techniques in recent years, percutaneous minimally invasive techniques such as radiofrequency ablation, sclerotherapy and cryoablation have played an increasing role in the management of these tumours with favourable outcomes. The different types of primary benign vertebral tumours will be discussed in this article with an emphasis on pertinent imaging features.

Primary Osseous Malignancies of the Spine.

Malignant primary vertebral tumours comprise an uncommon group of primary bone malignancies that can pose a diagnostic and therapeutic challenge. The most frequently encountered malignant primary vertebral tumours include chordoma, chondrosarcoma, Ewing sarcoma and osteosarcoma. These tumours often present with nonspecific symptoms, such as back pain, neurologic deficits and spinal instability, which can be confused for the more commonly encountered mechanical back pain and may delay their diagnosis and treatment. Imaging, including radiography, computed tomography (CT) and magnetic resonance imaging (MRI) is crucial for diagnosis, staging, treatment planning and follow-up. Surgical resection remains the mainstay of treatment for malignant primary vertebral tumours, but adjuvant radiotherapy and chemotherapy may be necessary for achieving complete tumour control depending on the type of tumour. In recent years, advances in imaging techniques and surgical approaches, such as en-bloc resection and spinal reconstruction, have improved the outcomes for patients with malignant primary vertebral tumours. However, the management can be complex due to the anatomy involved and the high morbidity and mortality associated with surgery. The different types of malignant primary vertebral lesions will be discussed in this article with an emphasis on the imaging features.

Accuracy of MRI scans in predicting intra-articular joint involvement in high-grade sarcomas around the knee.

Aims: Intra-articular (IA) tumours around the knee are treated with extra-articular (EA) resection, which is associated with poor functional outcomes. We aim to evaluate the accuracy of MRI in predicting IA involvement around the knee. Methods: We identified 63 cases of high-grade sarcomas in or around the distal femur that underwent an EA resection from a prospectively maintained database (January 1996 to April 2020). Suspicion of IA disease was noted in 52 cases, six had IA pathological fracture, two had an effusion, two had prior surgical intervention (curettage/IA intervention), and one had an osseous metastasis in the proximal tibia. To ascertain validity, two musculoskeletal radiologists (R1, R2) reviewed the preoperative imaging (MRI) of 63 consecutive cases on two occasions six weeks apart. The radiological criteria for IA disease comprised evidence of tumour extension within the suprapatellar pouch, intercondylar notch, extension along medial/lateral retinaculum, and presence of IA fracture. The radiological predictions were then confirmed with the final histopathology of the resected specimens. Results: The resection histology revealed 23 cases (36.5%) showing IA disease involvement compared with 40 cases without (62%). The intraobserver variability of R1 was 0.85 (p < 0.001) compared to R2 with κ = 0.21 (p = 0.007). The interobserver variability was κ = 0.264 (p = 0.003). Knee effusion was found to be the most sensitive indicator of IA involvement, with a sensitivity of 91.3% but specificity of only 35%. However, when combined with a pathological fracture, this rose to 97.5% and 100% when disease was visible in Hoffa's fat pad. Conclusion: MRI imaging can sometimes overestimate IA joint involvement and needs to be correlated with clinical signs. In the light of our findings, we would recommend EA resections when imaging shows effusion combined with either disease in Hoffa's fat pad or retinaculum, or pathological fractures.

Blood pressure in adolescents and young adults with type 1 diabetes: data from the Australasian Diabetes Data Network registry.

AIM: Hypertension increases complication risk in type 1 diabetes (T1D). We examined blood pressure (BP) in adolescents and young adults with T1D from the Australasian Diabetes Data Network, a prospective clinical diabetes registry in Australia and New Zealand. METHODS: This was a longitudinal study of prospectively collected registry data. INCLUSION CRITERIA: T1D (duration ≥ 1 year) and age 16-25 years at last visit (2011-2020). Hypertension was defined as (on ≥ 3 occasions) systolic BP and/or diastolic BP > 95th percentile for age < 18 years, and systolic BP > 130 and/or diastolic BP > 80 mmHg for age ≥ 18 years. Multivariable Generalised Estimating Equations were used to examine demographic and clinical factors associated with BP in the hypertensive range across all visits. RESULTS: Data from 6338 young people (male 52.6%) attending 24 participating centres across 36,655 T1D healthcare visits were included; 2812 (44.4%) had BP recorded at last visit. Across all visits, 19.4% of youth aged < 18 years and 21.7% of those aged ≥ 18 years met criteria for hypertension. In both age groups, BP in the hypertensive range was associated with male sex, injection (vs. pump) therapy, higher HbA1c, and higher body mass index. CONCLUSIONS: There is a high proportion of adolescents and young adults reported with BP persistently in hypertensive ranges. Findings flag the additive contribution of hypertension to the well-established body of evidence indicating a need to review healthcare models for adolescents and young adults with T1D.

A Comparison of Magnetic Resonance Imaging and SPECT-CT Imaging in Complex Spine Pathology: Does SPECT-CT Provide Additional Diagnostic Information Over Magnetic Resonance Imaging?

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: Magnetic Resonance Imaging (MRI) is often regarded as the gold standard for spinal pathology, as it provides good structural visualisation. SPECT-CT, however, provides combined structural and functional information. There is a paucity of literature comparing SPECT-CT with MRI in the spine. Our aim was to determine whether SPECT-CT provides additional information to MRI in individuals with complex spinal pathology, including deformity, which altered management. METHODS: We conducted a retrospective review of all individuals seen at our tertiary spinal unit that were investigated with both MRI and SPECT-CT of the spine between 2007-2020. We reviewed imaging reports, and collated diagnoses, surgical treatment and the relative contributions of MRI and SPECT-CT to management decisions. RESULTS: 104 individuals identified, with a mean age of 30 years (89 females and 15 males). Diagnostic categories were adolescent, adult, and congenital deformity, degenerative pathology, and miscellaneous pathology. MRI returned positive findings in 58 (55.8%), and SPECT-CT in 41 (39.4%) cases. SPECT-CT identified 10 cases of facet joint degeneration, 5 of increased uptake around metalwork suggestive of loosening, 1 pseudoarthrosis, 1 partial failure of fusion and 1 osteoid osteoma which were not reported on MRI, all in individuals who had previously undergone spinal instrumentation. Despite this, SPECT-CT only altered management for 6 individuals (5.8%). CONCLUSIONS: MRI is less useful in the setting of previous instrumentation due to metal artefact. Where MRI is inconclusive, particularly in individuals with previous spinal instrumentation, SPECT-CT may provide a diagnosis, but is not recommended as primary imaging.

A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patients.

PURPOSE: The aims of this pilot randomised controlled trial (RCT) were to assess the safety and efficacy of a human dermal allograft patch and assess the feasibility of a future RCT comparing retear rate and functional outcome 12 months following standard and augmented double-row rotator cuff repair. METHODS:  A pilot RCT was conducted among patients undergoing arthroscopic repair of rotator cuff tear measuring between 1 and 5 cm. They were randomised to either augmented (double-row repair with human acellular dermal patch) or standard (double-row repair only). The primary outcome was rotator cuff retear determined on MRI scan at 12 months using the Sugaya's classification (grade 4 or 5). All adverse events were recorded. Functional assessment was performed at baseline and 3, 6, 9, and 12 months post-surgery using clinical outcome scores. Safety was assessed by complications and adverse effects, and feasibility by recruitment, follow-up rate and proof of concept statistical analyses of a future trial. RESULTS: Between 2017 and 2019, 63 patients were considered for inclusion. Twenty-three patients were excluded, leaving 40 patients (20 per group) in the final study population. The mean tear sizes were 3.0 cm in the augmented and 2.4 cm in the standard group. There was one adhesive capsulitis in the augmented group, with no other adverse events. Retear was observed in 4/18 (22%) of patients in the augmented and 5/18 (28%) in the standard group. In both groups, functional outcome improved significantly which was clinically meaningful for all scores, with no difference between groups. Retear rate increased with tear size. Future trials are feasible but need a minimum total sample size of 150 patients. CONCLUSION:  Clinically meaningful improved function without adverse effects was found with human acellular dermal patch-augmented cuff repairs. LEVEL OF EVIDENCE: Level II.