Introduction Fatty infiltration (FI) of the rotator cuff (RC) muscles reflects chronic deterioration in muscle quality associated with tendon injury, disuse, ageing and nerve injury. Accurate and reliable assessment of FI based on imaging interpretation is essential for evaluating muscle degeneration, guiding rehabilitation planning and enabling meaningful comparisons across clinical and research settings. Several semi-qualitative grading systems and quantitative measurement approaches across imaging modalities, including CT, MRI, ultrasound and advanced techniques such as Dixon MRI have been used to assess FI; however, the reproducibility of FI grading or quantification at the level of image interpretation varies widely. This protocol outlines a systematic review and meta-analysis designed to evaluate the inter-rater and intra-rater reliability of imaging-based FI assessment at the level of image interpretation in RC disorders.Methods and analysis The review will follow the Preferred Reporting Items for Systematic Review and Meta-Analyses Protocols (PRISMA-P) guidelines and is preregistered in PROSPERO (CRD420251242564). Searches will be conducted in MEDLINE, Embase, CINAHL, Web of Science and the Cochrane Library from inception to the search date. Two reviewers will independently screen, extract data and assess study quality using the Quality Appraisal of Reliability Studies (QAREL) checklist. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) framework will be used to guide interpretation of reliability-related measurement properties. The primary outcomes will be inter-rater and intra-rater reliability reflecting the consistency of image-based FI grading or quantification. Where appropriate, pooled reliability estimates will be calculated separately by imaging modality (eg, MRI, CT and US) and by type of reliability (inter-rater and intra-rater). When quantitative pooling is not feasible because of limited studies or substantial heterogeneity, findings will be synthesised narratively and presented in summary tables. These will be synthesised using a restricted maximum likelihood random-effects model in R software, version 4.3.2 (R Foundation for Statistical Computing, Vienna, Austria) with the metafor package.Ethics and dissemination Ethical approval is not required as the review will use only published data. The results will be disseminated through a peer-reviewed publication and conference presentations to inform research and clinical practice in musculoskeletal imaging.PROSPERO registration number CRD420251242564.
BACKGROUND:Informed self-management is the first-line treatment for male lower urinary tract symptoms (LUTS), although the extent of delivery in primary care is unclear. The TReating Urinary symptoms in Men in Primary Health care (TRIUMPH) cluster randomised controlled trial (reference: ISRCTN11669964) compared a structured self-management intervention with usual care for men with LUTS. We report on embedded qualitative interviews. AIM:To investigate men's experiences of LUTS, engagement with primary care, and responses to a self-management intervention, along with the perspectives of primary care clinicians in order to inform the delivery of self-management guidance in primary care. DESIGN & SETTING:Qualitative interview study embedded in the TRIUMPH trial, which was conducted across 30 general practice sites in the South West of England. METHOD:Semi-structured interviews were conducted with 58 men with LUTS (selected purposively from the TRIUMPH trial population) and 14 treating clinicians (recruited from the TRIUMPH trial primary care sites), then analysed using thematic analysis. RESULTS:Men with LUTS were characterised as 'languishing', poorly informed, discounting symptoms as 'just old men's problems', and experiencing prostate-specific antigen (PSA) testing cycles that did not resolve their LUTS. GPs described a focus on LUTS self-management being restricted by clinical pressures and attending to prostate cancer concerns. The TRIUMPH self-help intervention booklet was strongly valued by men: many reported that it gave them a greater understanding of their symptoms and self-management options, reduced anxiety, and that using it improved their LUTS and quality of life. A few men, however, found the intervention unrewarding. CONCLUSION:Explanations and tailored self-management support were liked and found useful by many men with LUTS. Recommendations for clinical practice include: avoiding the expression 'old men's problems', ensuring LUTS follow-up after PSA testing, focusing on symptoms and self-management approaches, and distributing the TRIUMPH booklet widely.
Borderline-resectable pancreas cancer(BRPC) is defined by extent of peri-pancreatic vascular involvement. BRPC patients have been demonstrated to have improved survival outcomes when treated with neo-adjuvant systemic chemotherapy(NAC). Pre-operative anatomical interpretation to define those likely to benefit from NAC is a crucial step in ensuring patients undergo optimal treatments. A prospectively maintained surgical database was reviewed between 1/1/2020 and 31/12/2023. Patients with incomplete data were excluded. We reviewed pre-operative radiological(CT) and endoscopic ultrasound(EUS) reports to compare with intra-operative findings and post-operative histology. 19 patients underwent combined Whipple/Total Pancreatectomy and vascular(SMV/PV) resection: 8 underwent NAC, 1 was deemed physiologically inappropriate for NAC and 10 were intra-operatively diagnosed with vascular involvement. Of 8 patients undergoing NAC, pre-operative radiology described vessel abutment/contact in 100% and deformity in 63%; whereas, EUS identified vessel involvement in 63%. Histological vein involvement was confirmed in 7/8. The patient deemed physiologically inappropriate for NAC was reported as having vessel contact at CT and contour deformity on EUS; however, post-operative histology reported no venous involvement. All 10 operatively diagnosed patients were assessed as having no vessel involvement at pre-operative radiology/EUS; histology confirmed venous involvement in only 1. Pre-operative anatomical interpretation and staging of BRPC remains crucial but challenging. In this subset of patients undergoing combined pancreatic/vascular resection, the optimum sensitivity/specificity was defined by pre-operative radiological assessment. Intra-operative diagnoses of vessel involvement were more likely due to inflammation/desmoplastic change. A multi-modal approach may improve accuracy of pre-operative assessment of vascular involvement.
BACKGROUND AND AIMS:Angiotensin-converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (ARB) prevent fibrosis progression in a preclinical model of steatotic liver disease. Our objective was to assess the impact of ACEi/ARB use on clinical outcomes in patients with metabolic dysfunction-associated steatotic liver diseases. APPROACH AND RESULTS:Using TriNetX, a nationwide database, we identified all patients with metabolic dysfunction-associated steatotic liver diseases from January 1, 2011, to December 31, 2019. Using a target trial emulation framework, ACEi/ARB users were matched with calcium channel blocker (CCB) users using propensity score matching (PSM). Patients were followed up to 10 years after the index date. Cox proportional hazards regression was used to determine the risk of mortality, major adverse liver outcomes, major adverse cardiac events, and incident cancers. Of the 35,988 eligible patients, 28,423 were ACEi/ARB users, and 7565 were CCB users. After PSM, 7238 pairs were well-balanced. ACEi/ARB use was associated with a significantly decreased mortality risk (HR: 0.59, 95% CI: 0.51-0.68). ACEi/ARB was associated with a significantly reduced risk of developing major adverse liver outcomes (HR: 0.70, 95% CI: 0.61-0.80), including ascites (HR: 0.78, 95% CI: 0.63-0.98) and HE (HR: 0.67, 95% CI: 0.57-0.78). ACEi/ARB use was also associated with a lower risk of major adverse cardiac events (HR: 0.82, 95% CI: 0.76-0.90) but not incident cancer (HR: 0.97, 95% CI: 0.86-1.10) compared with CCB. CONCLUSIONS:ACEi/ARB use in patients with metabolic dysfunction-associated steatotic liver diseases was associated with a reduced risk of mortality, major adverse liver outcomes, and major adverse cardiac events compared with CCB use. A large prospective study is needed for external validation.
BACKGROUND:Pancreatic cancer is a leading cause of cancer-related death. Surgery (with systemic therapy) provides the only chance for long-term survival, but carries a high risk of morbidity and mortality. Robust evidence from meta-analyses, essential in informing decisions, is thwarted by inconsistencies between studies. This systematic review determines the nature and degree of heterogenous outcome reporting in research evaluating curative pancreatic cancer surgery. METHODS:A literature search of Medline, Embase, Cochrane Central and clinicaltrials.gov from 2017 to 2023 for eligible randomised and prospective studies adhering to a PROSPERO registered protocol. RESULTS:Included were 156 studies reporting a total of 2088 outcomes which deduplicated to 399 unique endpoints. No single outcome was reported in all studies. 45 % were not defined. Adverse events and delivery of care measures (typically technical aspects of surgery) accounted for 60 % and 32 % of outcomes respectively, compared to 6 % evaluating physical functioning post-surgery. CONCLUSION:The vast number and diversity of outcomes in use demonstrates lack of discernment in choice and disparity over domains of importance. Further work is needed to embed uniform outcome definitions, harmonise data collection and refocus research on fewer outcomes of proven relevance. Developing consensus on these critical outcomes through a Core Outcome Set is recommended.
OBJECTIVES To answer a national research priority by comparing the risk -benefit and costs associated with reverse total shoulder replacement (RTSR) and anatomical total shoulder replacement (TSR) in patients having elective primary shoulder replacement for osteoarthritis. DESIGN Population based cohort study using data from the National Joint Registry and Hospital Episode Statistics for England. SETTING Public hospitals and publicly funded procedures at private hospitals in England, 2012-20. PARTICIPANTS Adults aged 60 years or older who underwent RTSR or TSR for osteoarthritis with intact rotator cuff tendons. Patients were identified from the National Joint Registry and linked to NHS Hospital Episode Statistics and civil registration mortality data. Propensity score matching and inverse probability of treatment weighting were used to balance the study groups. MAIN OUTCOME MEASURES The main outcome measure was revision surgery. Secondary outcome measures included serious adverse events within 90 days, reoperations within 12 months, prolonged hospital stay (more than three nights), change in Oxford Shoulder Score (preoperative to six month postoperative), and lifetime costs to the healthcare service. RESULTS The propensity score matched population comprised 7124 RTSR or TSR procedures (126 were revised), and the inverse probability of treatment weighted population comprised 12 968 procedures (294 were revised) with a maximum follow-up of 8.75 years. RTSR had a reduced hazard ratio of revision in the first three years (hazard ratio local minimum 0.33, 95% confidence interval 0.18 to 0.59) with no clinically important difference in revision -free restricted mean survival time, and a reduced relative risk of reoperations at 12 months (odds ratio 0.45, 95% confidence interval 0.25 to 0.83) with an absolute risk difference of -0.51% (95% confidence interval -0.89 to -0.13). Serious adverse events and prolonged hospital stay risks, change in Oxford Shoulder Score, and modelled mean lifetime costs were similar. Outcomes remained consistent after weighting. CONCLUSIONS This study's findings provide reassurance that RTSR is an acceptable alternative to TSR for patients aged 60 years or older with osteoarthritis and intact rotator cuff tendons. Despite a significant difference in the risk profiles of revision surgery over time, no statistically significant and clinically important differences between RTSR and TSR were found in terms of long term revision surgery, serious adverse events, reoperations, prolonged hospital stay, or lifetime healthcare costs.
Background Conservative therapies are recommended as initial treatment for male lower urinary tract symptoms. However, there is a lack of evidence on effectiveness and uncertainty regarding approaches to delivery. Objective The objective was to determine whether or not a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for lower urinary tract symptoms to usual care. Design This was a two-arm cluster randomised controlled trial. Setting The trial was set in 30 NHS general practice sites in England. Participants Participants were adult men (aged ≥ 18 years) with bothersome lower urinary tract symptoms. Interventions Sites were randomised 1 : 1 to deliver the TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions trial intervention or usual care to all participants. The TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions intervention comprised a standardised advice booklet developed for the trial from the British Association of Urological Surgeons’ patient information sheets, with patient and expert input. Patients were directed to relevant sections by general practice or research nurses/healthcare assistants following urinary symptom assessment, providing the manualised element. The healthcare professional provided follow-up contacts over 12 weeks to support adherence to the intervention. Main outcome measures The primary outcome was the validated patient-reported International Prostate Symptom Score 12 months post consent. Rather than the minimal clinically important difference of 3.0 points for overall International Prostate Symptom Score, the sample size aimed to detect a difference of 2.0 points, owing to the recognised clinical impact of individual symptoms. Results A total of 1077 men consented to the study: 524 in sites randomised to the intervention arm (n = 17) and 553 in sites randomised to the control arm (n = 13). A difference in mean International Prostate Symptom Score at 12 months was found (adjusted mean difference of –1.81 points, 95% confidence interval –2.66 to –0.95 points), with a lower score in the intervention arm, indicating less severe symptoms. Secondary outcomes of patient-reported urinary symptoms, quality of life specific to lower urinary tract symptoms and perception of lower urinary tract symptoms all showed evidence of a difference between the arms favouring the intervention. No difference was seen between the arms in the proportion of urology referrals or adverse events. In qualitative interviews, participants welcomed the intervention, describing positive effects on their symptoms, as well as on their understanding of conservative care and their attitude towards the experience of lower urinary tract symptoms. The interviews highlighted that structured, in-depth self-management is insufficiently embedded within general practitioner consultations. From an NHS perspective, mean costs and quality-adjusted life-years were similar between trial arms. The intervention arm had slightly lower mean costs (adjusted mean difference of –£29.99, 95% confidence interval –£109.84 to £22.63) than the usual-care arm, and a small gain in quality-adjusted life-years (adjusted mean difference of 0.001, 95% confidence interval –0.011 to 0.014). Conclusions The intervention showed a small, sustained benefit for men’s lower urinary tract symptoms and quality of life across a range of outcome measures in a UK primary care setting. Qualitative data showed that men highly valued the intervention. Intervention costs were marginally lower than usual-care costs. Limitations of the study included that trial participants were unmasked, with limited diversity in ethnicity and deprivation level. Additional research is needed to assess the applicability of the intervention for a more ethnically diverse population.. Trial registration This trial is registered as ISRCTN11669964. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/90/03) and is published in full in Health Technology Assessment; Vol. 28, No. 13. See the NIHR Funding and Awards website for further award information.
Frozen shoulder is a spontaneously self-resolving chronic inflammatory fibrotic human disease, which distinguishes the condition from most fibrotic diseases that are progressive and irreversible. Using single-cell analysis, we identify pro-inflammatory MERTK low CD48 + macrophages and MERTK + LYVE1 + MRC1+ macrophages enriched for negative regulators of inflammation which co-exist in frozen shoulder capsule tissues. Micro-cultures of patient-derived cells identify integrin-mediated cell-matrix interactions between MERTK+ macrophages and pro-resolving DKK3+ and POSTN+ fibroblasts, suggesting that matrix remodelling plays a role in frozen shoulder resolution. Cross-tissue analysis reveals a shared gene expression cassette between shoulder capsule MERTK+ macrophages and a respective population enriched in synovial tissues of rheumatoid arthritis patients in disease remission, supporting the concept that MERTK+ macrophages mediate resolution of inflammation and fibrosis. Single-cell transcriptomic profiling and spatial analysis of human foetal shoulder tissues identify MERTK + LYVE1 + MRC1+ macrophages and DKK3+ and POSTN+ fibroblast populations analogous to those in frozen shoulder, suggesting that the template to resolve fibrosis is established during shoulder development. Crosstalk between MerTK+ macrophages and pro-resolving DKK3+ and POSTN+ fibroblasts could facilitate resolution of frozen shoulder, providing a basis for potential therapeutic resolution of persistent fibrotic diseases.
Introduction Despite the high number of operations and surgical advancement, rehabilitation after rotator cuff repair has not progressed for over 20 years. The traditional cautious approach might be contributing to suboptimal outcomes. Our aim is to assess whether individualised (early) patient-directed rehabilitation results in less shoulder pain and disability at 12 weeks after surgical repair of full-thickness tears of the rotator cuff compared with current standard (delayed) rehabilitation.Methods and analysis The rehabilitation after rotator cuff repair (RaCeR 2) study is a pragmatic multicentre, open-label, randomised controlled trial with internal pilot phase. It has a parallel group design with 1:1 allocation ratio, full health economic evaluation and quintet recruitment intervention. Adults awaiting arthroscopic surgical repair of a full-thickness tear are eligible to participate. On completion of surgery, 638 participants will be randomised. The intervention (individualised early patient-directed rehabilitation) includes advice to the patient to remove their sling as soon as they feel able, gradually begin using their arm as they feel able and a specific exercise programme. Sling removal and movement is progressed by the patient over time according to agreed goals and within their own pain and tolerance. The comparator (standard rehabilitation) includes advice to the patient to wear the sling for at least 4 weeks and only to remove while eating, washing, dressing or performing specific exercises. Progression is according to specific timeframes rather than as the patient feels able. The primary outcome measure is the Shoulder Pain and Disability Index total score at 12-week postrandomisation. The trial timeline is 56 months in total, from September 2022.Trial registration number ISRCTN11499185.
Background and purpose: International variation exists in the types of shoulder replacement used for treatment of specific diseases. Implant choice continues to evolve without high-quality evidence. Our aim was to evaluate trends in incidence rates of shoulder replacement and assess any recent changes in practice between countries by using registry data. Methods: Patient characteristics, indication and year of surgery, type of replacement, and collection methods of patient-reported outcomes (PROMs) was extracted from 11 public joint registries. Meta-analyses examined use of reverse total shoulder replacement (RTSR) for osteoarthritis, cuff tear arthropathy, and acute fracture; use of anatomical total shoulder replacement (TSR) for osteoarthritis; and use of humeral hemiarthroplasty for fracture. Results: The annual growth rate of shoulder replacements performed is 6–15% (2011–2019). The use of RTSR has almost doubled (93%). RTSR is now universally performed for cuff tear arthropathy (97.3%, 95% confidence interval [CI] 96.0–98.1). Its use for avascular necrosis, trauma, and inflammatory arthropathy is increasing. The use of RTSR was similar (43.1%, CI 30.0–57.2) versus TSR (44.7%, CI 31.1–59.1) for osteoarthritis. The types of PROMs used, collection time points, and response rates lack standardization. COVID-19 had a varying inter-registry impact on incidence rates. Conclusion: The incidence of shoulder replacements has grown. Use of RTSR has increased for all disease indications despite limited high-quality evidence driving this change in indications outside of cuff arthropathy. Consequently, less variation is observed in international practice. Existing differences now relate to use of newer implant types and methodology of PROMs collection, which prevents international comparison and outcome analysis.
Objectives To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care.Design Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon.Setting Thirty NHS general practice sites in England.Participants 1077 men aged 18 or older identified in primary care with bothersome LUTS.Interventions A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites.Measures Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated.Results 866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs −£29.99 (95% CI −£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI −0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI −£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold.Conclusions Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost.Trial registration number ISRCTN11669964.
Abstract Background Soft/normal pancreas consistency is a known risk factor for postoperative pancreatic fistula (POPF) in patients who undergo pancreatoduodenectomy (PD) for malignancy. A hard pancreas is considered less technically challenging to work with and generally allows the formation of a more robust pancreatic anastomosis. This study aimed to investigate the impact of pancreas consistency and intra-operative pancreatitis on the incidence of POPF in PD patients. Methods Data was extracted from the Recurrence After Whipple’s (RAW) study, a multicentre retrospective cohort study of outcomes following PD performed for malignancy (29 centres in 8 countries, n=1484). Patients with operation notes which documented a subjective assessment of pancreas tissue consistency and whether there was intra-operative evidence of pancreatitis were included. The incidence of POPF and clinically relevant POPF (CR-POPF) was calculated and comparisons were made using the chi-squared test. The 2016 International Study Group of Pancreatic Fistula definitions were used. Results Of the 40.6% patients included, 41.5% had a soft/normal pancreas and 58.2% had a firm/hard pancreas. Both POPF (OR: 5.2, 95% CI: 3.3-8.3) and CR-POPF (OR: 4.7, 95% CI: 2.5-8.9) were significantly more common in the former (both p<0.0001). A soft/normal pancreas was most common in patients with cholangiocarcinoma and least common in those with pancreatic cancer (56.4% vs 33.4%). 32.6% had their intra-operative pancreatitis status documented. Of these, 22.8% had evidence of pancreatitis and 77.2% did not. POPF (11.8% vs 16.1%, p=0.3) and CR-POPF (8.2% vs 9.4%, p=0.7) rates were similar in these groups. Conclusion In our multicentre study of PD outcomes, POPF and CR-POPF were significantly more common in those with a soft/normal pancreas. This may have implications for postoperative management planning.
BACKGROUND:Radiofrequency Ablation (RFA) and Microwave Ablation (MWA) are alternative treatments for colorectal liver metastasis (CRLM) patients that are unsuitable for resection. However, consensus is lacking regarding selection criteria, tumour characteristics, ablation technique delivery, and device settings. This study aims to summarise current evidence to inform future prospective studies. METHODS:A systematic review was conducted following PRISMA guidelines. Studies assessing RFA and MWA treatment of CRLM were identified in Medline, Embase, Web of Science and the Cochrane database of systematic reviews, from inception until 31st August 2024. RESULTS:Fifty-two studies were included (retrospective cohort n = 45, prospective cohort n = 5, non-randomized comparative studies n = 2). Fifty-four inclusion criteria were used across 45 studies and were not stated in 7 studies. Tumours varied in mean number [1-8] and diameter (1.54-4.35 cm). Neoadjuvant chemotherapy use (10-100 % of patients), ablation delivery approach (open n = 4, laparoscopic n = 11, percutaneous n = 26, mixed n = 5), anaesthetic mode (GA n = 18, LA n = 11, mixed n = 2) and delivering clinician (radiologist n = 11, surgeon n = 16, both n = 1) all varied. Thirty-two studies lacked complete ablation device settings. Six studies followed a standardized ablation algorithm and 14 studies had specific settings. Five-year survival ranged from 0 to 69.7 % for ablation. CONCLUSIONS:There is significant heterogeneity in the reporting of study design, patient selection, and ablation techniques for CRLM. The lack of standardized approaches and inconsistent reporting of methodology and outcomes make it challenging to determine the optimal ablative treatment for CRLM. We recommend that future research should focus on clearly defining selection and treatment criteria, as well as treatment delivery.
BACKGROUND:Despite a rising rate of serious medical complications after shoulder replacement surgery, there are no prediction models in widespread use to guide surgeons in identifying patients at high risk and to provide patients with personalised risk estimates to support shared decision making. Our aim was to develop and externally validate a prediction model for serious adverse events within 90 days of primary shoulder replacement surgery. METHODS:Linked data from the National Joint Registry, National Health Service Hospital Episode Statistics Admitted Patient Care of England, and Civil Registration Mortality databases and Danish Shoulder Arthroplasty Registry and National Patient Register were used for our modelling study. Patients aged 18-100 years who had a primary shoulder replacement between April 1, 2012, and Oct 2, 2020, in England, and April 1, 2012, and Oct 2, 2018, in Denmark, were included. We developed a multivariable logistic regression model using the English dataset to predict the risk of 90-day serious adverse events, which were defined as medical complications requiring admission to hospital and all-cause death. We undertook internal validation using bootstrapping, and internal-external cross-validation across different geographical regions of England. The English model was externally validated on the Danish dataset. FINDINGS:Data for 40 631 patients undergoing primary shoulder replacement (mean age 72·5 years [SD 9·9]; 28 709 [70·7%] women and 11 922 [29·3%] men) were used for model development, of whom 2270 (5·6%) had a 90-day serious adverse event. On internal validation, the model had a C-statistic of 0·717 (95% CI 0·707-0·728) and was well calibrated. Internal-external cross-validation showed consistent model performance across all regions in England. Upon external validation on the Danish dataset (n=6653; mean age 70·5 years [SD 10·3]; 4503 [67·7%] women and 2150 [32·3%] men), the model had a C-statistic of 0·750 (95% CI 0·723-0·776). Decision curve analysis showed clinical utility, with net benefit across all risk thresholds. INTERPRETATION:This externally validated prediction model uses commonly available clinical variables to accurately predict the risk of serious medical complications after primary shoulder replacement surgery. The model is generalisable and applicable to most patients in need of a shoulder replacement. Its use offers support to clinicians and could inform and empower patients in the shared decision-making process. FUNDING:National Institute for Health and Care Research and the Department of Orthopaedic Surgery, Herlev and Gentofte Hospital, Denmark.
Primary total hip replacement (THR) is a successful and common operation which orthopaedic trainees must demonstrate competence in prior to completion of training. This study aimed to determine the impact of operating surgeon grade and level of supervision on the incidence of 1-year patient mortality and all-cause revision following elective primary THR in a large UK training centre. National Joint Registry (NJR) data for all elective primary THR performed in a single University Teaching Hospital from 2005–2020 were used, with analysis performed on the 15-year dataset divided into 5-year temporal periods (B1 2005–2010, B2 2010–2015, B3 2015–2020). Outcome measures were mortality and revision surgery at one year, in relation to lead surgeon grade, and level of supervision for trainee-led operations. 9999 eligible primary THR were undertaken, of which 5526 (55.3%) were consultant led (CL), and 4473 (44.7%) trainees led (TL). Of TL, 2404 (53.7%) were non-consultant supervised (TU), and 2069 (46.3%) consultant supervised (TS). The incidence of 1-year patient mortality was 2.05% (n=205), and all-cause revision was 1.11% (n=111). There was no difference in 1-year mortality between TL (n=82, 1.8%) and CL (n=123, 2.2%) operations (p=0.20, OR 0.78, CI 0.55–1.10). The incidence of 1-year revision was not different for TL (n=56, 1.3%) and CL (n=55, 1.0%) operations (p=0.15, OR 1.37, CI 0.89–2.09). Overall, there was no temporal change for either outcome measure between TL or CL operations. A significant increase in revision within 1-year was observed in B3 between TU (n=17, 2.7%) compared to CL (n=17, 1.0%) operations (p=0.005, OR 2.81, CI 1.35–5.87). We found no difference in 1-year mortality or 1-year all-cause revision rate between trainee-led primary THR and consultant-led operations over the entire fifteen-year period. However, unsupervised trainee led THR in the most recent 5-year block (2015–2020) has a significantly increased risk of early revision, mainly due to instability and prosthetic joint infection. This suggests that modern surgical training is having a detrimental effect on THR patient outcomes. More research is needed to understand the reasons if this trend is to be reversed.
Background: The strength of tendon repair is dependent on the quality of the core suture. Organic and synthetic materials have been used to simulate tendon repair for training; however, no model has undergone construct validation. Objectives: To determine the construct validity of a novel synthetic tendon repair model. Methods: Synthetic silicone tendon models were used to simulate adult Achilles tendon (AT) and digital flexor tendon (FT). Participants were categorised into novice, intermediate, and advanced groups based on prior surgical experience. Participants repaired tendons using the modified Kessler technique. A validated motion analysis system was used to measure the duration, path length, and movement count during the simulated task. A global rating score was also used to assess the performance. Results: All participants in the novice (n = 12), intermediate (n = 8) and advanced (n = 11) groups completed the tasks. The results (mean +/- standard deviation) were duration (872 +/- 335, 492 +/- 257 and 357 +/- 40 s), path length (9493 +/- 3173, 6668 +/- 1740 and 4672 +/- 1228 cm), movement count (4974 +/- 673, 4228 +/- 259 and 3962 +/- 69) and global rating (39 +/- 13, 61 +/- 14, 81 +/- 5), respectively. The Kruskal-Wallis test was significant for all outcome measures (p < 0.01). Significant differences in duration and movement count were identified post-hoc in the AT model for each experience group (p < 0.05), and between novice and intermediate participants for FT repair (p < 0.04). Global rating was significantly different between all groups and was highly correlated with motion metrics (p < 0.01). Conclusion: The results support construct validity of this novel simulated tendon repair model. The global rating scores may allow wide utility of this simulation. This model provides a valid and safe environment for surgical trainees to practice tendon repair with several cost, ethical and logistical benefits over animal tendon use. 248/250 (c) 2024 Published by Elsevier Ltd on behalf of British Association of Plastic, Reconstructive and Aesthetic Surgeons.
Abstract Background Post-cholecystectomy syndrome (PCS) is a term commonly used to refer to the persistence of abdominal symptoms following cholecystectomy, or de-novo symptoms that develop post operatively. Despite the common use of the term, there is no widely agreed upon consensus definition. PCS is reported to affect between 5-40% of patients that undergo cholecystectomy representing a large populational burden. Despite this, there are no guidelines or protocols in place for the routine investigation and management of this large heterogenous patient group. In this study we systematically review the literature describing definition, aetiology, investigation and up-to-date management of PCS. Method An updated systematic search of the Medline, EMBASE and Cochrane databases was undertaken to identify studies where patients underwent cholecystectomy and subsequently were diagnosed with PCS. Included papers were published between 2016-2024, had a minimum of 10 cases of PCS following laparoscopic or open cholecystectomy. Excluded studies were case reports, narrative and systematic reviews, paediatric patient population or papers unavailable in the English language. Paper characteristics were extracted and where present, the definition of PCS, aetiology, investigations and management of these patients was both extracted and analysed. Results 145 papers were identified of which 13 were included after title, abstract and full text screening. Definition of PCS, where present, was highly heterogenous between papers. Aetiology was often divided into biliary and non-biliary causes, with some papers claiming early-PCS and late-PCS as distinct clinical phenomena. In such papers, early-PCS was most commonly attributed to gastro-oesophageal pathologies and late-PCS to biliary pathologies. Investigation strategy is sparingly reported and without guideline or protocol. Most frequently used tests include LFTs, USS, MRCP, CT, ERCP and OGD. Some studies also used 99m Tc-Mebrofenin Hepatobiliary Scintigraphy, sphincter manometry and colonoscopy. Conclusion PCS has a widely reported prevalence in the published literature. This is potentially due to the heterogeneity of definitions used to cover the syndrome. The effective management of such patients depends on both the accurate diagnosis of the underlying cause, as well as exclusion of procedure related complications. There are currently no guidelines or protocols available for the investigation and management of patients presenting with symptoms post cholecystectomy despite the large populational burden. Further studies should aim to provide a consensus definition of PCS, and work towards guidelines for the investigation and management of this patient group.