Recent Submissions

  • A systematic review and meta-analysis of diagnostic performance of fluorescein-guided sentinel lymph node biopsy in early breast cancer

    Goyal, Amit
    BACKGROUND: Evaluation of axillary lymph nodes status in cN0 axilla is performed by sentinel lymph node biopsy (SLNB) utilizing a combination of radioactive isotope and blue dye or alternative to isotope like Indocyanine green (ICG). Both are very resource-intensive; which has prompted development of low-cost technique of Fluorescein Sodium (FS)-guided SLNB. This systematic review and meta-analysis evaluate the diagnostic performance of FS-guided SLNB in early breast cancer. OBJECTIVES: The objective was to evaluate the diagnostic performance of FS for sentinel lymph node biopsy. METHODS: Eligibility criteria: Studies where SLNB was performed using FS. INFORMATION SOURCES: PubMed, EMBASE, Cochrane library and online clinical trial registers. Risk of bias: Articles were assessed for risk of bias using the QUADAS-2 tool. SYNTHESIS OF RESULTS: The main summary measures were pooled Sentinel Lymph Node Identification Rate (SLN-IR) and pooled False Negative Rate (FNR) using random-effects model. RESULTS: A total of 45 articles were retrieved by the initial systematic search. 7 out of the 45 studies comprising a total of 332 patients were included in the meta-analysis. The pooled SLN-IR was 93.2% (95% confidence interval [CI], 0.87-0.97; 87% to 97%). Five validation studies were included for pooling the false negative rate and included a total of 211 patients. The pooled FNR was 5.6% (95% confidence interval [CI], 2.9-9.07). CONCLUSION: Fluorescein-guided SLNB is a viable option for detection of lymph node metastases in clinically node negative patients with early breast cancer. It achieves a high pooled Sentinel Lymph Node Identification Rate (SLN-IR) of 93% with a false negative rate of 5.6% for the detection of axillary lymph node metastasis.
  • Does long-term follow-up and monitoring of primary shoulder arthroplasty identify failing implants requiring revision?

    Morris, D.L.J.; Dover, Caroline; Walstow, Katherine; Pitt, Lisa; Morgan, Marie; Espag, Marius; Clark, David; Tambe, Amol
    BACKGROUND: Published scoping review has identified evidence paucity related to long-term follow-up of shoulder arthroplasty. We aim to report effectiveness of elective primary shoulder arthroplasty surveillance in identifying failing implants requiring revision. METHODS: A prospective database recording shoulder arthroplasty and subsequent follow-up surveillance in a shoulder unit was analyzed. Shoulder arthroplasty was performed by 4 fellowship-trained shoulder surgeons for accepted elective indications including the use of anatomic arthroplasty in arthritic shoulders with intact rotator cuff and a reverse prosthesis being used in rotator cuff-deficient shoulders and rotator cuff-competent arthritic shoulders when deemed preferable by the treating surgeon. All shoulder arthroplasty implants used had achieved a minimum 7A Orthopaedic Data Evaluation Panel (ODEP) rating. The included shoulder arthroplasties were performed between May 1, 2004, and December 31, 2021, with minimum 1-year follow-up. Surveillance program involves specialist physiotherapist review at 1, 2, 3, 5, 8, 10, and 15 years postoperatively, including clinical examination, outcome scoring, and radiographs. Patient-initiated review occurred between time points if a patient requested assessment because of symptoms. Outcome measures include ratio of failing implants identified by surveillance and patient-initiated review, with number of surveillance reviews offered and proportion that identified a failing implant requiring revision calculated. RESULTS: A total of 1002 elective primary shoulder arthroplasty with minimum 1-year follow-up were performed (547 reverse total shoulder arthroplasty [rTSA], 234 anatomic total shoulder arthroplasty [aTSA], and 221 hemiarthroplasty [HA]). A total of 238 patients died prior to December 31, 2022, resulting in 4019 surveillance appointments offered. Thirty-eight prostheses required revision ≥1 year postoperatively (6 rTSA, 9 aTSA, and 23 HA), with surveillance identifying requirement in 53% (33% rTSA, 56% aTSA, and 57% HA) and patient-initiated review in 47%. Mean years from implantation to revision was 5.2 (2.7 rTSA, 3.6 aTSA, and 6.6 HA). Revision indications included rotator cuff failure (56% aTSR and 43% HA) and glenoid erosion (57% HA). CONCLUSION: This is the first series reporting effectiveness of shoulder arthroplasty surveillance in identifying implants requiring revision. Surveillance identified more than half of implants requiring revision, although only 0.5% of appointments identified revision requirement. Surveillance enrolment may influence patient-initiated review utilization; therefore, similar studies using only patient-initiated follow-up would help inform recommendations.
  • LymphActiv: A Digital Physical Activity Behavior Intervention for the Treatment of Lymphedema and Lipedema.

    Riches, Katie; Keeley, Vaughan
    Background: Lymphedema and lipedema are debilitating conditions with no proven drug or surgical therapy. Effective treatment requires self-management through movement and compression to reduce limb volume and the incidence of cellulitis. The addition of personalized everyday physical activity (PA) could be transformative, increasing the therapy window to include all waking hours per week and enabling an increased dose of PA. Aim: This service evaluation aimed to determine the feasibility of LymphActiv as a treatment option for lymphedema and lipedema patients. Methods: This service evaluation followed an open observational cohort design, including 55 patients who participated in LymphActiv over 24 weeks. Patients wore an objective PA monitor and interacted with their data in an online dashboard, alongside remote mentor support. Primary outcomes were changes to PA, body weight, limb volume and quality of life. Clinical assessments occurred at baseline and after the 24-week program. Noncompleters were used as a quasi-control group for comparison. Results: Thirty-seven patients completed, of which 81% improved PA. On average, completers reduced their right and left lower limb volumes by -1.8% and -2.1%, respectively. Completers also experienced small average weight losses of -1.2 kg. Noncompleters experienced small average increases in each of these outcome measures. Discussion: These results establish the value of LymphActiv, providing benefit to patients who might otherwise have deteriorated. For services, this could lead to substantial cost-savings through reduced admissions, greater patient independence, and less need for community health care input. The next step is to undertake a randomized, controlled trial comparing the intervention with standard care.
  • Emotion Regulation and Psychological Dependence on Pain Medication among Hospital Outpatients with Chronic Spinal Pain: The Influence of Rumination about Pain and Alexithymia.

    Bateman, AH
    Objective: To examine the extent to which pain acceptance, pain catastrophising and alexithymia moderate associations between pain intensity and psychological pain medication dependence. Methods: Participants (106 hospital outpatients with chronic spinal pain) completed the Leeds Dependence Questionnaire (LDQ) to measure psychological dependence on pain medication, and the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), the Pain Catastrophising Scale (PCS) and the Toronto Alexithymia Scale-20 (TAS-20), plus the Depression, Anxiety and Stress Scale-21 (DASS-21). Results: Multiple linear regression showed that degree of psychological dependence (measured dimensionally across the range of LDQ scores) was associated with TAS subscale difficulty identifying feelings (DIF) (β = 0.249, p = <0.002) and PCS subscale rumination (β = 0.193, p = 0.030), independently of pain intensity and risk behaviors for medication misuse. The effect of pain intensity was moderated by rumination, with pain intensity more strongly associated with dependence when rumination was high (interaction β = 0.192, p = 0.004). Logistic regression showed that the effect of pain intensity on severe dependence (measured categorically as LDQ score ≥ 20) was moderated by alexithymia, so that severe dependence was independently associated with the combination of intense pain and high alexithymia (interaction odds ratio = 7.26, 95% CIs = 1.63-32.42, p = 0.009). Conclusions: Rumination and alexithymia moderated the associations between pain intensity and psychological pain medication dependence, consistent with emotion regulation theory. This raises the possibility that specifically targeting rumination about pain and symptoms of alexithymia could potentially improve the effectiveness of psychological interventions for chronic pain and help people to avoid or reduce their psychological dependence on pain medication.
  • Regular follow-up with cervical cytology is of questionable value following surgical treatment of microinvasive cervical cancer.

    Ashmore, Ayisha; Abdul, Summi; Phillips, Andrew; Bali, Anish; Tamizian, Onnig; Asher, Viren
    OBJECTIVES: To assess the follow-up smears and their outcomes of patients with conservatively managed early-stage cervical cancer as per UK guidelines within our service. To evaluate whether intensive follow-up can detect pre-cancer early compared to the standard 3 yearly follow-up. STUDY DESIGN: Retrospective review. METHODS: All patients treated for early stage (stage 1A1 and 1A2) with cervical cancer from 01/2002 to 01/2020 at University Hospitals of Derby and Burton were included. Patients who had initial hysterectomy were excluded from our analysis. Review conducted using electronic patient records for treatment, histology, and follow-up smears. Number of abnormal follow-up smears and number of recurrent cervical cancers were considered the main outcome measures. RESULTS: 98 cases were identified. 81 (82.65 %) were stage 1A1 and 17 (17.35 %) were stage 1A2. 74 (75.51 %) patients had squamous histology and 24 (24.49 %) had adenocarcinomas. Median follow-up was 11.08 years (4043 days). 510 follow-up smears were performed, of which 33 (6.47 %) were abnormal. 5 of these abnormal smears showed low grade dyskaryosis (0.98 %) and 2 smears showed high grade dyskaryosis (0.39 %). The positive predictive value of follow-up smears to detect pre-cancerous changes was 5.71 %. There were no recurrent cancers detected. CONCLUSIONS: Microinvasive cervical cancer is effectively managed with conservative surgery. There were no recurrent cancers detected in our cohort during follow-up and there were only 2 high grade dyskaryoses detected (n = 2/510, 0.39 %). We therefore believe that reducing the intensity of follow up of these patients should be considered.
  • A 10-month impact evaluation of a journal club among diagnostic radiographers in a single NHS Trust: A service evaluation study

    Iweka, Edozie
    Introduction: Journal clubs (JC) have emerged as a popular tool within medical and health professions to deliver outcomes such as promotion of evidence-based practice (EBP), improvement of critical appraisal skills, as well as stimulation of research interest among participating professionals. However, the delivery of these outcomes within the diagnostic radiography profession has not been evidenced and this is the aim of this service evaluation. Methods: This evaluation adopted a pre- and post-evaluation survey design to explore the impact of a novel JC introduced among diagnostic radiographers in a UK NHS Trust. Impact was assessed based on four pre-determined outcomes such as Knowledge of EBP, Attitude to EBP, Critical Appraisal Skill and Research interest. Open ended questions in the post evaluation survey were also used to obtain participants feedback on JC activities attended. Results: Evaluation of the four pre-determined outcomes indicated that JC activities participated by diagnostic radiographers resulted in positive changes across all evaluated categories. Attitude to EBP was the only outcome to show a statistically significant positive change across all participants, highlighting that the JC affected EBP attitudes positively for those that attended. Furthermore, thematic analysis of open-ended questions indicated that the collaboration experienced among JC members during critical appraisal of articles was a motivation for continued participation while factors such as high clinical workload and absence of management in meetings were identified as mitigating barriers. Conclusion: Participation in the JC showed positive improvements in all pre-determined categories. The collaborative nature of JC was motivating for staff, however barriers such as management absence in meetings, and high clinical workload did cause some challenges. Research is recommended to look at the longer-term impact of JC activities amongst diagnostic radiographers.
  • Identifying clusters of objective functional impairment in patients with degenerative lumbar spinal disease using unsupervised learning.

    Klukowska, Anita
    OBJECTIVES: The five-repetition sit-to-stand (5R-STS) test was designed to capture objective functional impairment (OFI), and thus provides an adjunctive dimension in patient assessment. It is conceivable that there are different subsets of patients with OFI and degenerative lumbar disease. We aim to identify clusters of objectively functionally impaired individuals based on 5R-STS and unsupervised machine learning (ML). METHODS: Data from two prospective cohort studies on patients with surgery for degenerative lumbar disease and 5R-STS times of ≥ 10.5 s-indicating presence of OFI. K-means clustering-an unsupervised ML algorithm-was applied to identify clusters of OFI. Cluster hallmarks were then identified using descriptive and inferential statistical analyses. RESULTS: We included 173 patients (mean age [standard deviation]: 46.7 [12.7] years, 45% male) and identified three types of OFI. OFI Type 1 (57 pts., 32.9%), Type 2 (81 pts., 46.8%), and Type 3 (35 pts., 20.2%) exhibited mean 5R-STS test times of 14.0 (3.2), 14.5 (3.3), and 27.1 (4.4) seconds, respectively. The grades of OFI according to the validated baseline severity stratification of the 5R-STS increased significantly with each OFI type, as did extreme anxiety and depression symptoms, issues with mobility and daily activities. Types 1 and 2 are characterized by mild to moderate OFI-with female gender, lower body mass index, and less smokers as Type I hallmarks. CONCLUSIONS: Unsupervised learning techniques identified three distinct clusters of patients with OFI that may represent a more holistic clinical classification of patients with OFI than test-time stratifications alone, by accounting for individual patient characteristics.
  • Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2).

    Sherman, Rachelle; Ireland, Katie; Connan, Zak; Tildsley, Jack; Bateman, Marcus; Fakis, Apostolos
    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.
  • The Effects of Preoperative Glycaemic Control (HbA1c) on Bariatric and Metabolic Surgery Outcomes: Data from a Tertiary-Referral Bariatric Centre in the UK.

    Wilmington, Rebekah; Abuawwad, Mahmoud; Holt, Guy; Anderson, Robyn; Aldafas, Rami; Awad, Sherif; Idris, Iskandar
    Background: Current recommendations advocate the achievement of an optimal glucose control (HbA1c < 69 mmol/mol) prior to elective surgery to reduce risks of peri- and post-operative complications, but the relevance for this glycaemic threshold prior to Bariatric Metabolic Surgery (BMS) following a specialist weight management programme remains unclear. Methods: We undertook a retrospective cohort study of patients with type 2 diabetes mellitus (T2DM) who underwent BMS over a 6-year period (2016-2022) at a regional tertiary referral following completion of a specialist multidisciplinary weight management. Post-operative outcomes of interest included 30-day mortality, readmission rates, need for Intensive Care Unit (ICU) care and hospital length of stay (LOS) and were assessed according to HbA1c cut-off values of < 69 (N = 202) and > 69 mmol/mol (N = 67) as well as a continuous variable. Results: A total of 269 patients with T2D were included in this study. Patients underwent primary Roux en-Y gastric bypass (RYGB, n = 136), Sleeve Gastrectomy (SG, n = 124), insertion of gastric band (n = 4) or one-anastomosis gastric bypass (OAGB, n = 4). No significant differences in the rates of complications were observed between the two groups of pre-operative HbA1c cut-off values. No HbA1c threshold was observed for glycaemic control that would affect the peri- and post-operative complications following BMS. Conclusions: We observed no associations between pre-operative HbA1C values and the risk of peri- and post-operative complications. In the context of a specialist multidisciplinary weight management programme, optimising pre-operative HbA1C to a recommended target value prior to BMS may not translate into reduced risks of peri- and post-operative complications. Keywords: Bariatric surgery; Complications; Glycated haemoglobin; HbA1c; Intensive care; Length of stay; Mortality; Peri-operative; Post-operative; Type 2 diabetes.
  • Flexor Injury Rehabilitation Splint Trial (FIRST): protocol for a pragmatic randomised controlled trial comparing three splints for finger flexor tendon repairs

    Bamford, E; Selby, A
    BACKGROUND: Without surgical repair, flexor tendon injuries do not heal and patients' ability to bend fingers and grip objects is impaired. However, flexor tendon repair surgery also requires optimal rehabilitation. There are currently three custom-made splints used in the rehabilitation of zone I/II flexor tendon repairs, each with different assumed harm/benefit profiles: the dorsal forearm and hand-based splint (long), the Manchester short splint (short), and the relative motion flexion splint (mini). There is, however, no robust evidence as to which splint, if any, is most clinical or cost effective. The Flexor Injury Rehabilitation Splint Trial (FIRST) was designed to address this evidence gap. METHODS: FIRST is a parallel group, superiority, analyst-blind, multi-centre, individual participant-randomised controlled trial. Participants will be assigned 1:1:1 to receive either the long, short, or mini splint. We aim to recruit 429 participants undergoing rehabilitation following zone I/II flexor tendon repair surgery. Potential participants will initially be identified prior to surgery, in NHS hand clinics across the UK, and consented and randomised at their splint fitting appointment post-surgery. The primary outcome will be the mean post-randomisation score on the patient-reported wrist and hand evaluation measure (PRWHE), assessed at 6, 12, 26, and 52 weeks post randomisation. Secondary outcome measures include blinded grip strength and active range of movement (AROM) assessments, adverse events, adherence to the splinting protocol (measured via temperature sensors inserted into the splints), quality of life assessment, and further patient-reported outcomes. An economic evaluation will assess the cost-effectiveness of each splint, and a qualitative sub-study will evaluate participants' preferences for, and experiences of wearing, the splints. Furthermore, a mediation analysis will determine the relationship between patient preferences, splint adherence, and splint effectiveness. DISCUSSION: FIRST will compare the three splints with respect to clinical efficacy, complications, quality of life and cost-effectiveness. FIRST is a pragmatic trial which will recruit from 26 NHS sites to allow findings to be generalisable to current clinical practice in the UK. It will also provide significant insights into patient experiences of splint wear and how adherence to splinting may impact outcomes. TRIAL REGISTRATION: ISRCTN: 10236011.
  • Can an educational video improve the adequacy of bowel preparation for patients undergoing their first colonoscopy? Results of the EBOPS RCT

    Cole, Andrew
    Background and study aims: The aim of this study was to assess the effect of an educational video on the quality of bowel preparation of patients from a UK population attending for their first colonoscopy. Patients and methods A prospective, endoscopist-blinded trial with 1:1 allocation was performed. Patients referred for their first colonoscopy were recruited between February 2019 and December 2019. All participants were prescribed Moviprep and received the trial site's standard written bowel preparation instructions, with the intervention group also receiving a bespoke educational video. Adequacy of bowel preparation (defined as a Boston Bowel Preparation Scale of ≥2 in each segment of the bowel) and polyp detection rates (PDRs) were compared. Fisher's chi squared test was utilized with P <0.05 as the threshold for significance. Results A total of 509 participants completed the trial from six centers; 251 were randomized to the intervention group. The mean age was 57 years and 52.3% were female. The primary endpoint was met with an adequacy rate of 216 of 251 (86.1%) in the intervention group, compared with 205 of 259 (79.1%) in the control group ( P <0.05, odds ratio [OR] 1.626, 95% CI 1.017-2.614). The PDR was significantly higher in the intervention group (39% vs 30%, OR 1.51, 95% CI 1.04-2.19, P <0.05). Conclusions: An educational video leads to improved bowel preparation for patients attending for their first colonoscopy, and is also associated with greater detection of polyps. Widespread adoption of an educational video incurs minimal investment, but would reduce the number of inadequate procedures, missed pathology, and the cost that both these incur.
  • Response to Laden et al.

    Tabner, Andrew; Johnson, Graham
    N/A
  • Regular follow-up with cervical cytology is of questionable value following surgical treatment of microinvasive cervical cancer.

    Ashmore, Ayisha; Abdul, Summi; Phillips, Andrew; Bali, Anish; Tamizian, Onnig
    OBJECTIVES: To assess the follow-up smears and their outcomes of patients with conservatively managed early-stage cervical cancer as per UK guidelines within our service. To evaluate whether intensive follow-up can detect pre-cancer early compared to the standard 3 yearly follow-up. STUDY DESIGN: Retrospective review. METHODS: All patients treated for early stage (stage 1A1 and 1A2) with cervical cancer from 01/2002 to 01/2020 at University Hospitals of Derby and Burton were included. Patients who had initial hysterectomy were excluded from our analysis. Review conducted using electronic patient records for treatment, histology, and follow-up smears. Number of abnormal follow-up smears and number of recurrent cervical cancers were considered the main outcome measures. RESULTS: 98 cases were identified. 81 (82.65 %) were stage 1A1 and 17 (17.35 %) were stage 1A2. 74 (75.51 %) patients had squamous histology and 24 (24.49 %) had adenocarcinomas. Median follow-up was 11.08 years (4043 days). 510 follow-up smears were performed, of which 33 (6.47 %) were abnormal. 5 of these abnormal smears showed low grade dyskaryosis (0.98 %) and 2 smears showed high grade dyskaryosis (0.39 %). The positive predictive value of follow-up smears to detect pre-cancerous changes was 5.71 %. There were no recurrent cancers detected. CONCLUSIONS: Microinvasive cervical cancer is effectively managed with conservative surgery. There were no recurrent cancers detected in our cohort during follow-up and there were only 2 high grade dyskaryoses detected (n = 2/510, 0.39 %). We therefore believe that reducing the intensity of follow up of these patients should be considered.
  • Patient characteristics, treatment patterns, and outcomes for patients with renal cell carcinoma in England: a retrospective cohort study

    Das, P
    Background and Objective Considering the rapidly evolving treatment landscape of renal cell carcinoma (RCC), recent descriptions of the RCC population in the UK are lacking, as are real-world data on treatment and patient outcomes. To analyse the demographic and clinical characteristics, treatment patterns, and overall survival of patients with RCC using national data sets in England. Patients and Methods This was a retrospective cohort study of patients diagnosed with RCC (all stages) between 2014-2018 using demographic, clinical, cancer registration, and treatment data. Patients were followed until death or study end (31 December 2020). Treatments administered in each line were described to understand treatment sequencing. Kaplan–Meier methods were used for time-to-event analyses. Factors associated with discontinuation and survival were identified using Cox proportional hazard models. Results and Limitations Among 32,577 included patients, the median age at diagnosis was 66 years, 63.4% were male, and 6,786 (20.8%) had metastatic RCC at diagnosis. Tyrosine kinase inhibitor (TKI) monotherapy was the most common treatment class across lines. Over three quarters of patients (78.5% [95% CI 78.0–78.9]) were alive one year after diagnosis (93.2% in the non-metastatic at diagnosis subgroup and 37.1% among patients with metastases at diagnosis). At three years post initial diagnosis, 18.0% patients were alive in the metastatic at diagnosis subgroup. Rapid evolution of the treatment landscape limits the results regarding lines of therapy. Conclusion This large-scale study provides insight on characteristics of patients with RCC, and it highlights the need for better treatment options to improve survival. MicroAbstract: Treatment pathways and survival outcomes were assessed for patients with the most common form of kidney cancer (renal cell carcinoma) in England using national data. In total, 32,577 patients were included. Over three quarters of patients were alive one year after diagnosis (93.2% in the non-metastatic subgroup and 37.1% among patients with metastases at diagnosis).
  • Real-world outcomes of Omnipod DASH system use in people with type 1 diabetes: Evidence from the Association of British Clinical Diabetologists (ABCD) study.

    Wilmot, Emma; Liarakos, Alexandros; Hasan, Nebras; Crabtree, Thomas
    AIMS: To evaluate real-world outcomes in people with Type 1 Diabetes (PwT1D) initiated on Omnipod DASH® Insulin Management System. METHODS: Anonymized clinical data were submitted to a secure web-based tool within the National Health Service network. Hemoglobin A1c (HbA1c), sensor-derived glucometrics, total daily dose of insulin (TDD), and patient-reported outcome changes between baseline and follow-up were assessed. Individuals were classified to "new-to-pump" (switched from multiple daily injections) and "established-on-pump" (switched from a tethered insulin pump) groups. RESULTS: 276 individuals from 11 centers [66.7 % female; 92 % White British; median age 41 years (IQR 20-50); diabetes duration 20 years (IQR 11-31); 49.3 % within "new-to-pump" group] were included. Baseline HbA1c was 8.0 ± 1.3 % (64 ± 14 mmol/mol). At follow-up [3 years (IQR 1.5-3.2)], HbA1c reduced by 0.3 % [(3 mmol/mol); p = 0.002] across the total population, 0.4 % [(5 mmol/mol); p = 0.001] in those "new-to-pump" and remained unchanged in those "established-on-pump". TDD decreased in the "new-to-pump" cohort (baseline:44.9 ± 21.0units vs follow-up:38.1 ± 15.4units, p = 0.002). Of those asked, 141/143 (98.6 %) stated Omnipod DASH had a positive impact on quality of life. CONCLUSIONS: Omnipod DASH was associated with improvements in HbA1c in PwT1D "new-to-pump" and maintained previous HbA1c levels in those "established-on-pump". User satisfaction in all groups and TDD reduction in those "new-to-pump" were reported.
  • Frequency and reporting of complications after Dupuytren's contracture interventions: A systematic review and meta-analysis.

    Johnson, Nick
    INTRODUCTION: Numerous complications are reported following interventions for Dupuytren's contracture; however, their incidence, management, and outcomes remain poorly reported. The aims of this review were to report the proportions of complications, compare likelihood of complications between interventions, and evaluate reporting of complications, including assessment, grading, management, and subsequent reporting of their impact on patient outcomes. METHODS: Extracted data included patient demographics, intervention details, complications, their management, and final outcomes. Analysis of descriptive data enabled review of complications reporting. Meta-analysis(MA) of non-comparative datasets enabled estimation of proportions of patients experiencing complications. Network meta-analysis(NMA) of comparative studies estimated the relative occurrence of complications between interventions. Risk of bias analysis was performed. RESULTS: 26 studies, comprising 10,831 patients, were included. Interventions included collagenase injection, percutaneous needle fasciotomy(PNF), limited fasciectomy(LF), open fasciotomy(OF), and dermofasciectomy(DF). Overall quality and consistency of outcomes reporting was poor. MA enabled estimates of probabilities for three common complications(infection, nerve injury, complex regional pain syndrome(CRPS)) across all interventions; the reported rates for LF were 4.5% for infection, 3% for nerve injury, and 3.3% for CRPS. As the commonest intervention, LF was used as the reference intervention for comparison of the commonest complications via NMA, including haematoma [OF OR 0.450(0.277, 0.695); PNF OR 0.245(0.114, 0.457)], infection [PNF OR 0.2(0.0287, 0.690); DF OR 2.02(1.02, 3.74)], and neuropraxia [PNF OR 0.0926(0.00553, 0.737)]. We noted that the complication incidence was higher the more invasive the intervention. CONCLUSIONS: There was limited reporting of complication occurrence, management, and outcomes following interventions, contributing to a gap in information for informed patient consent. MA was possible for reporting of proportions for infection, nerve injury, and CRPS across interventions. NMA enabled direct comparison of the six commonest complications between interventions. These findings can guide intervention selection. Improving consistency and quality in complications reporting is essential to aid counselling of patients regarding the true rates and consequences of the risks of interventions. TYPE OF STUDY/LEVEL OF EVIDENCE: 2.
  • Exploring the utility of bedside tests for predicting cardiorespiratory fitness in older adults.

    Carrick, Laura; Doleman, Brett; Wall, Jillian; Lund, Jonathan; Williams, John
    OBJECTIVES: Cardiorespiratory fitness (CRF) declines with advancing and has also, independent of age, been shown to be predictive of all-cause mortality, morbidity, and poor clinical outcomes. In relation to the older patient, there is a particular wealth of evidence highlighting the relationship between low CRF and poor surgical outcomes. Cardiopulmonary exercise testing (CPET) is accepted as the gold-standard measure of CRF. However, this form of assessment has significant personnel and equipment demands and is not feasible for those with certain age-associated physical limitations, including joint and cardiovascular comorbidities. As such, alternative ways to assess the CRF of older patients are very much needed. METHODS: Sixty-four participants (45% female) with a median age of 74 (65-90) years were recruited to this study via community-based advertisements. All participants completed three tests of physical function: (1) a step-box test; (2) handgrip strength dynamometry; and (3) a CPET on a cycle ergometer; and also had their muscle architecture (vastus lateralis) assessed by B-mode ultrasonography to provide measures of muscle thickness, pennation angle, and fascicle length. Multivariate linear regression was then used to ascertain bedside predictors of CPET parameters from the alternative measures of physical function and demographic (age, gender, body mass index (BMI)) data. RESULTS: There was no significant association between ultrasound-assessed parameters of muscle architecture and measures of CRF. VO2peak was predicted to some extent from fast step time during the step-box test, gender, and BMI, leading to a model that achieved an R 2 of 0.40 (p < 0.001). Further, in aiming to develop a model with minimal assessment demands (i.e., using handgrip dynamometry rather than the step-box test), replacing fast step time with non-dominant HGS led to a model which achieved an R 2 of 0.36 (p < 0.001). Non-dominant handgrip strength combined with the step-box test parameter of fast step time and BMI delivered the most predictive model for VO2peak with an R 2 of 0.45 (p < 0.001). CONCLUSIONS: Our findings show that simple-to-ascertain patient characteristics and bedside assessments of physical function are able to predict CPET-derived CRF. Combined with gender and BMI, both handgrip strength and fast step time during a step-box test were predictive for VO2peak. Future work should apply this model to a clinical population to determine its utility in this setting and to explore if simple bedside tests are predictive of important clinical outcomes in older adults (i.e., post-surgical complications).
  • Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: protocol for a multicentre, randomised controlled trial with integrated Quintet Recruitment Intervention (RaCeR 2).

    Sherman, Rachelle; Ireland, Katie; Connan, Zak; Tildsley, Jack; Bateman, Marcus; Fakis, Apostolos
    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.
  • Patient-reported outcomes in inguinal hernia surgery-Results from the GENESIS study: A multinational multicenter study.

    Viswanath, Gokhare; Madhok, Brijesh
    BACKGROUND: Chronic groin pain following inguinal hernia repair can be troublesome. The current literature is limited, especially from Asia and Africa. We aimed to evaluate patient-reported outcomes using the Carolinas Comfort Scale (CCS) following inguinal hernia repair at an international level, especially to include patients from Asia and Africa. METHODS: An international cohort of surgeons was invited to collaborate and collect data of consecutive adult patients who underwent inguinal hernia repair. The data were collected to allow at least 2 years of follow-up. A total score for CCS was calculated and compared for the following groups-patient age <30 years versus (vs.) > 30 years; open versus laparoscopic repair, emergency versus elective surgery, and unilateral versus bilateral hernia repair. The CCS scores between Asia, Africa, and Europe were also compared. RESULTS: The mean total CCS score of patients operated in Asia (n = 891), Europe (n = 853), and Africa (n = 157) were 7.32, 14.6, and 19.79, respectively. The total CCS score was significantly higher following open repair, emergency repair, and unilateral repair, with surgical site infections (SSI) and recurrence. In the subgroup analysis, the patients who underwent elective open repair in Europe had higher CCS scores than those in Asia. CONCLUSION: About 15% of patients had a CCS score of more than 25 after a minimum follow-up of 2 years. The factors that influence CCS scores are indication, approach, complications, and geographic location.
  • Emotion Regulation and Psychological Dependence on Pain Medication among Hospital Outpatients with Chronic Spinal Pain: The Influence of Rumination about Pain and Alexithymia.

    Bateman, AH
    Objective: To examine the extent to which pain acceptance, pain catastrophising and alexithymia moderate associations between pain intensity and psychological pain medication dependence. Methods: Participants (106 hospital outpatients with chronic spinal pain) completed the Leeds Dependence Questionnaire (LDQ) to measure psychological dependence on pain medication, and the Chronic Pain Acceptance Questionnaire-8 (CPAQ-8), the Pain Catastrophising Scale (PCS) and the Toronto Alexithymia Scale-20 (TAS-20), plus the Depression, Anxiety and Stress Scale-21 (DASS-21). Results: Multiple linear regression showed that degree of psychological dependence (measured dimensionally across the range of LDQ scores) was associated with TAS subscale difficulty identifying feelings (DIF) (β = 0.249, p = <0.002) and PCS subscale rumination (β = 0.193, p = 0.030), independently of pain intensity and risk behaviors for medication misuse. The effect of pain intensity was moderated by rumination, with pain intensity more strongly associated with dependence when rumination was high (interaction β = 0.192, p = 0.004). Logistic regression showed that the effect of pain intensity on severe dependence (measured categorically as LDQ score ≥ 20) was moderated by alexithymia, so that severe dependence was independently associated with the combination of intense pain and high alexithymia (interaction odds ratio = 7.26, 95% CIs = 1.63-32.42, p = 0.009). Conclusions: Rumination and alexithymia moderated the associations between pain intensity and psychological pain medication dependence, consistent with emotion regulation theory. This raises the possibility that specifically targeting rumination about pain and symptoms of alexithymia could potentially improve the effectiveness of psychological interventions for chronic pain and help people to avoid or reduce their psychological dependence on pain medication.

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