Empowering pharmacists working in primary care through a cardiovascular disease clinical management course: Impact on practice.

INTRODUCTION: Cardiovascular disease (CVD) is currently the leading cause of mortality and morbidity worldwide. A competent healthcare workforce working in primary care delivering disease management services efficiently is the cornerstone of well performing health systems, impacting patient outcomes positively. The aim of this study was to evaluate the effectiveness of a training course to support pharmacists working in General Practitioner (GP) practices; and to evaluate its impact on practice. METHODS: A before and after evaluation model was employed to assess the effectiveness of training resorting to a survey exploring self-confidence and knowledge on clinical management of three CVD topics: Atrial Fibrillation (AF), Hypertension and hyperlipidaemia. Before and after training data (immediate and retained after 6 months) were analysed at the Primary Care Network (PCN) and GP Practice level of the pharmacists who took part in the training sessions. Data were analysed in IBM SPSS v.29 resorting to paired samples t-test and Cohen's d for estimation of the effect size. Independent samples t-tests were performed for a sample group of PCNs and GP practices with and without training (comparator group). RESULTS: An improvement with large effect size was observed in pharmacists' self-confidence and knowledge related to the hypertension topic, suggesting potential practical benefit. For the topics of AF and hyperlipidaemia, pharmacists' confidence also increased with a large effect size, but for knowledge, the effect size of the increase was medium or small. Data suggests that pharmacists' practice has improved in both groups after 6 months, which suggests that it was not a sole result of the training. CONCLUSIONS: This study provide evidence that the course improved pharmacists' knowledge and self-confidence, likely to contribute to performance in their clinical practice. Patients' clinical benefit is expected from pharmacists' improved capacity to effectively engage in medicines optimisation.

Differential impact of COVID-19 on mental health and burnout.

BACKGROUND: There may be differential impact of the COVID-19 pandemic on mental health and burnout rates of healthcare professionals (HCPs) performing different roles. AIMS: To examine mental health and burnout rates, and possible drivers for any disparities between professional roles. METHODS: In this cohort study, online surveys were distributed to HCPs in July-September 2020 (baseline) and re-sent 4 months later (follow-up; December 2020) assessing for probable major depressive disorder (MDD), generalized anxiety disorder (GAD), insomnia, mental well-being and burnout (emotional exhaustion and depersonalization). Separate logistic regression models (at both phases) compared the risk of outcomes between roles: healthcare assistants (HCAs), nurses and midwives (nurses), allied health professionals (AHPs) and doctors (reference group). Separate linear regression models were also developed relating the change in scores to professional role. RESULTS: At baseline (n = 1537), nurses had a 1.9-fold and 2.5-fold increased risk of MDD and insomnia, respectively. AHPs had a 1.7-fold and 1.4-fold increased risk of MDD and emotional exhaustion, respectively. At follow-up (n = 736), the disproportionate risk between doctors and others worsened: nurses and HCAs were at 3.7-fold and 3.6-fold increased risk of insomnia, respectively. Nurses also had a significantly increased risk of MDD, GAD, poor mental well-being and burnout. Nurses also had significantly worsened anxiety, mental well-being and burnout scores over time, relative to doctors. CONCLUSIONS: Nurses and AHPs had excess risk of adverse mental health and burnout during the pandemic, and this difference worsened over time (in nurses especially). Our findings support adoption of targeted strategies accounting for different HCP roles.

European Association for Endoscopic Surgery (EAES) consensus on Indocyanine Green (ICG) fluorescence-guided surgery.

BACKGROUND: In recent years, the use of Indocyanine Green (ICG) fluorescence-guided surgery during open and laparoscopic procedures has exponentially expanded across various clinical settings. The European Association of Endoscopic Surgery (EAES) initiated a consensus development conference on this topic with the aim of creating evidence-based statements and recommendations for the surgical community. METHODS: An expert panel of surgeons has been selected and invited to participate to this project. Systematic reviews of the PubMed, Embase and Cochrane libraries were performed to identify evidence on potential benefits of ICG fluorescence-guided surgery on clinical practice and patient outcomes. Statements and recommendations were prepared and unanimously agreed by the panel; they were then submitted to all EAES members through a two-rounds online survey and results presented at the EAES annual congress, Barcelona, November 2021. RESULTS: A total of 18,273 abstracts were screened with 117 articles included. 22 statements and 16 recommendations were generated and approved. In some areas, such as the use of ICG fluorescence-guided surgery during laparoscopic cholecystectomy, the perfusion assessment in colorectal surgery and the search for the sentinel lymph nodes in gynaecological malignancies, the large number of evidences in literature has allowed us to strongly recommend the use of ICG for a better anatomical definition and a reduction in post-operative complications. CONCLUSIONS: Overall, from the systematic literature review performed by the experts panel and the survey extended to all EAES members, ICG fluorescence-guided surgery could be considered a safe and effective technology. Future robust clinical research is required to specifically validate multiple organ-specific applications and the potential benefits of this technique on clinical outcomes.

A systematic review of outcome reporting in incisional hernia surgery.

BACKGROUND: The incidence of incisional hernia is up to 20 per cent after abdominal surgery. The management of patients with incisional hernia can be complex with an array of techniques and meshes available. Ensuring consistency in reporting outcomes across studies on incisional hernia is important and will enable appropriate interpretation, comparison and data synthesis across a range of clinical and operative treatment strategies. METHODS: Literature searches were performed in MEDLINE and EMBASE (from 1 January 2010 to 31 December 2019) and the Cochrane Central Register of Controlled Trials. All studies documenting clinical and patient-reported outcomes for incisional hernia were included. RESULTS: In total, 1340 studies were screened, of which 92 were included, reporting outcomes on 12 292 patients undergoing incisional hernia repair. Eight broad-based outcome domains were identified, including patient and clinical demographics, hernia-related symptoms, hernia morphology, recurrent incisional hernia, operative variables, postoperative variables, follow-up and patient-reported outcomes. Clinical outcomes such as hernia recurrence rates were reported in 80 studies (87 per cent). A total of nine different definitions for detecting hernia recurrence were identified. Patient-reported outcomes were reported in 31 studies (34 per cent), with 18 different assessment measures used. CONCLUSIONS: This review demonstrates the significant heterogeneity in outcome reporting in incisional hernia studies, with significant variation in outcome assessment and definitions. This is coupled with significant under-reporting of patient-reported outcomes.

Suture fixation versus self-gripping mesh for open inguinal hernia repair: a systematic review with meta-analysis and trial sequential analysis.

INTRODUCTION: Morbidity following open inguinal hernia repair is mainly related to chronic pain. ProGrip™ is a self-gripping mesh which aims to reduce rates of chronic pain. The aim of this study is to perform an update meta-analysis to consolidate the non-superiority hypothesis in terms of postoperative pain and recurrence and perform a trial sequential analysis. METHODS: Systematic review of randomised controlled trials performed according to PRISMA guidelines. Pooled odds ratios with 95% confidence intervals (CI) were calculated using the Mantel-Haenszel (M-H) method. The primary outcome measure was postoperative pain and secondary outcomes were recurrence, operative time, wound complications, length of stay, re-operation rate, and cost. Trial sequential analysis was performed. RESULTS: There were 14 studies included in the quantitative analysis with 3180 patients randomised to self-gripping mesh (1585) or standard mesh (1595). At all follow-up time points, there was no significant difference in the rates of chronic pain between the self-gripping and standard mesh (risk ratio, RR 1.10, 95% confidence interval, CI 0.83-1.46). There were no significant differences in recurrence rates (RR 1.13, CI 0.84-2.04). The mean operating time was significantly shorted in the ProGrip™ mesh group (MD - 7.32 min, CI - 10.21 to - 4.44). Trial sequential analysis suggests findings are conclusive. CONCLUSION: This meta-analysis has confirmed no benefit of a ProGrip™ mesh when compared to a standard sutured mesh for open inguinal hernia repair in terms of chronic pain or recurrence. No further trials are required to address this clinical question.

Rectal stump management in inflammatory bowel disease: a cohort study, systematic review and proportional analysis of perioperative complications.

BACKGROUND: The aim of this study was to analyse local single-institution data and perform a systematic review of the literature to calculate precise risk estimates of rectal stump-related morbidity and mortality following subtotal colectomy in patients with inflammatory bowel disease (IBD), including Crohn's colitis, ulcerative colitis and indeterminate colitis. METHODS: Institutional information systems were interrogated to obtain local patient data. A systematic review of MEDLINE and EMBASE was performed to identify relevant articles. Fixed-effects or random-effects meta-analysis of proportions was performed to calculate pooled incidence estimates, including local data. RESULTS: Sixty-one patients were included locally and all had their rectal stump closed intra-abdominally. Four patients (8.3%) had a rectal stump perforation and 30-day mortality was 0. Fourteen papers were included in our review alongside local data, with a total of 1330 patients included. Pooled mortality was 1.7% (95% confidence interval, CI 1.0-2.8), pooled incidence of pelvic abscess/sepsis, stump leak and wound infection was 5.7% (95% CI 4.4-7.3), 4.9% (95% CI 3.7-6.6) and 11.3% (95% CI 7.8-16), respectively. Subcutaneous placement of the stump was associated with the highest incidence of stump leak (12.6%, 95% CI 8.3-18.6), and closure of the stump with both staples and suture was associated with the highest incidence of pelvic abscess (11.1%, 95% CI 5.8-20.3). Mortality and the incidence of wound infection were similar across stump closure techniques. There was evidence suggesting considerable heterogeneity and publication bias among studies. CONCLUSIONS: This study provides estimates of morbidity associated with the rectal stump after subtotal colectomy for IBD. A closed intra-abdominal stump seems to be associated with the highest rate of pelvic abscess/sepsis. Further work in form of an international collaborative project would allow individual patient data analysis and identification of risk factors for complications.

Field observations and experiences gained from the implementation of control measures against lumpy skin disease in South-East Europe between 2015 and 2017.

The first epidemics of lumpy skin disease (LSD) reported in Europe in 2015 severely affected the cattle farming sector in several Balkan countries. After the first incursion into Greece in 2015, the disease quickly spread across the Balkan region with over 7000 outbreaks reported by the end of 2016. Thanks to a coordinated regional control and eradication policy, the spread of the disease was halted by the end of 2017. Regional large-scale vaccination campaign with effective homologous vaccines and high vaccination coverage revealed to be essential for the successful control the disease, supported by other measures such as early detection of outbreaks, total or partial stamping out and restrictions on cattle movements. The aim of this paper is to discuss the field observations, challenges and lessons learnt while dealing with the first LSD epidemics in Europe. The cross-border collaboration by the veterinary authorities of all affected countries, coordinated by the European Commission and the technical support provided by many other international organizations played a fundamental role in stopping the spread of a disease that otherwise could have expanded further to the European territory causing a large damage to the whole European cattle farming industry. The experience obtained during the control of LSD epidemics indicates that in the future LSD spread can be effectively halted, provided that appropriate surveillance plans and vigilance remains in place in the areas at risk of re-incursion, especially those bordering endemic countries.

Systematic review and meta-analysis of incisional hernia post-reversal of ileostomy.

PURPOSE: Incisional hernia following closure of loop ileostomy is a common problem. Assessment of the proportion of this complication is limited by small sample size and inconsistent reporting. The aim of this review was to provide an estimate of the proportion of incisional hernia following closure of loop ileostomy according to clinical and radiological diagnostic criteria and to investigate the association of bibliometric and study quality parameters with reported proportion. METHODS: A systematic review of PubMed, Embase, CENTRAL, ISRCTN Registry and Open Grey from 2000 onwards was performed according to PRISMA standards. Reporting on the type of stoma and mesh reinforcement after closure was mandatory for inclusion, whereas studies on paediatric populations were excluded. Fixed effect or random effects models were used to calculate pooled proportion estimates. Meta-regression models were formed to explore potential heterogeneity. RESULTS: 42 studies with 7166 patients were included. The pooled estimate of the proportion of incisional hernia after ileostomy closure was 6.1% (95% confidence interval, CI 4.4-8.3%). Proportion estimates for higher quality studies and studies reporting on incisional hernia as primary outcome were 9.0% (95% CI 6.3-12.7%) and 13.1% (95% CI 8.8-19.1%). Significant between-study heterogeneity was identified (P < 0.001, I2 = 87%) and the likelihood of publication bias was high (P = 0.028). Mixed effects regression showed that both year of publication (P = 0.034, Q = 4.484, df = 1.000) and defining hernia as a primary outcome (Q = 20.298, P < 0.001) were related to effect size. Method of follow-up and quality of the studies affected the proportion. CONCLUSION: The proportion of incisional hernia at ileostomy closure site is estimated at 6.1%. Reporting incisional hernia as primary or secondary outcome, the method of diagnosis, the year of publication and methodological quality are associated with reported proportion.

Open versus laparoscopic mesh repair of primary unilateral uncomplicated inguinal hernia: a systematic review with meta-analysis and trial sequential analysis.

BACKGROUND: One standard repair technique for groin hernias does not exist. The objective of this study is to perform an update meta-analysis and trial sequential analysis to investigate if there is a difference in terms of recurrence between laparoscopic and open primary unilateral uncomplicated inguinal hernia repair. METHODS: The reporting methodology conforms to PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) guidelines. Randomised controlled trials only were included. The intervention was laparoscopic mesh repair (transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP)). The control group was Lichtenstein repair. The primary outcome was recurrence rate and secondary outcomes were acute and chronic post-operative pain, morbidity and quality of life. RESULTS: This study included 12 randomised controlled trials with 3966 patients randomised to Lichtenstein repair (n = 1926) or laparoscopic repair (n = 2040). There were no significant differences in recurrence rates between the laparoscopic and open groups (odds ratio (OR) 1.14, 95% CI 0.51-2.55, p = 0.76). Laparoscopic repair was associated with reduced rate of acute pain compared to open repair (mean difference 1.19, CI - 1.86, - 0.51, p ≤ 0.0006) and reduced odds of chronic pain compared to open (OR 0.41, CI 0.30-0.56, p ≤ 0.00001). The included trials were, however, of variable methodological quality. Trial sequential analysis reported that further studies are unlikely to demonstrate a statistically significant difference between the two techniques. CONCLUSION: This meta-analysis and trial sequential analysis report no difference in recurrence rates between laparoscopic and open primary unilateral inguinal hernia repairs. Rates of acute and chronic pain are significantly less in the laparoscopic group.

The potential of breath analysis to improve outcome for patients with lung cancer.

Lung cancer remains the most common cause of cancer related death in both the UK and USA. Development of diagnostic approaches that have the ability to detect lung cancer early are a research priority with potential to improve survival. Analysis of exhaled breath metabolites, or volatile organic compounds (VOCs) is an area of considerable interest as it could fulfil such requirements. Numerous studies have shown that VOC profiles are different in the breath of patients with lung cancer compared to healthy individuals or those with non-malignant lung diseases. This review provides a scientific and clinical assessment of the potential value of a breath test in lung cancer. It discusses the current understanding of metabolic pathways that contribute to exhaled VOC production in lung cancer and reviews the research conducted to date. Finally, we highlight important areas for future research and discuss how a breath test could be incorporated into various clinical pathways.

Short-term results after laparoscopic repair of giant hiatal hernias with pledgeted sutures: a retrospective analysis.

PURPOSE: This study investigates if pledgeted sutures for hiatal closure could be an alternative to mesh for the surgical treatment of large hiatal hernia. METHODS: Forty-one patients who underwent laparoscopic 270° Toupet fundoplication with pledgeted sutured crura between September 2014 and April 2017 were evaluated with regard to recurrence of hiatal hernia at 3 months and 1 year after surgery. Indication for pledgets was a hiatal surface area of at least 5.60 cm2, or migration of more than 1/3 of the stomach into the thorax or preoperative hernia size > 5 cm. The integrity of repair was assessed using a barium swallow test 3 months and 1 year after surgery. RESULTS: All operations could be completed laparoscopically with no intraoperative complications. Until study end no complications related to the pledgets have occurred. Forty-four of 50 patients (88.0%) completed the follow-up radiographic examination 3 months (mean 12.7 weeks) after surgery, and 37 patients (74.0%; mean 55.1 weeks) 1 year after surgery. Postoperative recurrence was diagnosed in 3/44 patients (6.8%) at 3 months, and in 4/37 patients (10.8%) at 1 year follow-up. Only one patient was symptomatic, 1 year after surgery (2.7%). All other patients with reherniations were asymptomatic at time of the study. CONCLUSIONS: Utilization of pledgets to reinforce hiatal sutures seems safe and shows a quite low early recurrence rate compared to other methods. Long-term data will allow firm conclusions as to whether pledgeted sutures are an appropriate solution for the treatment of giant hiatal hernias.

EHS clinical guidelines on the management of the abdominal wall in the context of the open or burst abdomen.

PURPOSE: To provide guidelines for all surgical specialists who deal with the open abdomen (OA) or the burst abdomen (BA) in adult patients both on the methods used to close the musculofascial layers of the abdominal wall, and regarding possible materials to be used. METHODS: The guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach including publications up to January 2017. When RCTs were available, outcomes of interest were quantitatively synthesized by means of a conventional meta-analysis. When only observational studies were available, a meta-analysis of proportions was done. The guidelines were written using the AGREE II instrument. RESULTS: For many of the Key Questions that were researched, there were no high quality studies available. While some strong recommendations could be made according to GRADE, the guidelines also contain good practice statements and clinical expertise guidance which are distinct from recommendations that have been formally categorized using GRADE. RECOMMENDATIONS: When considering the OA, dynamic closure techniques should be prioritized over the use of static closure techniques (strong recommendation). However, for techniques including suture closure, mesh reinforcement, component separation techniques and skin grafting, only clinical expertise guidance was provided. Considering the BA, a clinical expertise guidance statement was advised for dynamic closure techniques. Additionally, a clinical expertise guidance statement concerning suture closure and a good practice statement concerning mesh reinforcement during fascial closure were proposed. The role of advanced techniques such as component separation or relaxing incisions is questioned. In addition, the role of the abdominal girdle seems limited to very selected patients.

EHS clinical guidelines on the management of the abdominal wall in the context of the open or burst abdomen

To provide guidelines for all surgical specialists who deal with the open abdomen (OA) or the burst abdomen (BA) in adult patients both on the methods used to close the musculofascial layers of the abdominal wall, and regarding possible materials to be used. The guidelines were developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach including publications up to January 2017. When RCTs were available, outcomes of interest were quantitatively synthesized by means of a conventional meta-analysis. When only observational studies were available, a meta-analysis of proportions was done. The guidelines were written using the AGREE II instrument. For many of the Key Questions that were researched, there were no high quality studies available. While some strong recommendations could be made according to GRADE, the guidelines also contain good practice statements and clinical expertise guidance which are distinct from recommendations that have been formally categorized using GRADE. When considering the OA, dynamic closure techniques should be prioritized over the use of static closure techniques (strong recommendation). However, for techniques including suture closure, mesh reinforcement, component separation techniques and skin grafting, only clinical expertise guidance was provided. Considering the BA, a clinical expertise guidance statement was advised for dynamic closure techniques. Additionally, a clinical expertise guidance statement concerning suture closure and a good practice statement concerning mesh reinforcement during fascial closure were proposed. The role of advanced techniques such as component separation or relaxing incisions is questioned. In addition, the role of the abdominal girdle seems limited to very selected patients.

Meta-analysis and trial sequential analysis of local vs. general anaesthesia for carotid endarterectomy.

Controversy exists regarding the best choice of anaesthesia for carotid endarterectomy. We aimed to evaluate the peri-operative outcomes of local vs. general anaesthesia for carotid endarterectomy. We conducted a systematic search of electronic information sources and applied a combination of free text and controlled vocabulary searches adapted to thesaurus headings, search operators and limits in each of the electronic databases. We defined peri-operative stroke, transient ischaemic attack, mortality and myocardial infarction as the primary outcome measures. We identified 12 randomised controlled trials and 21 observational studies reporting a total of 58,212 patients undergoing carotid endarterectomy under local or general anaesthesia. Analysis of observational studies demonstrated that local anaesthesia was associated with a significantly lower incidence of stroke (odds ratio (OR (95% CI) 0.66 (0.55-0.80), p < 0.0001), transient ischaemic attack (0.52 (0.38-0.70), p < 0.0001), myocardial infarction (0.55 (0.41-0.75), p = 0.0002) and mortality (0.72 (0.56-0.94), p = 0.01) compared with general anaesthesia. Analysis of randomised controlled trials did not find a significant difference in the risk of stroke (0.92 (0.67-1.28), p = 0.63), transient ischaemic attack (2.20 (0.48-10.03), p = 0.31), myocardial infarction (1.25 (0.57-2.72), p = 0.58) or mortality (0.61 (0.35-1.05), p = 0.07) between local and general anaesthesia. On trial sequential analysis of the randomised trials, the Z-curve did not cross the α-spending boundaries or futility boundaries for stroke, mortality and transient ischaemic attack, suggesting that more trials are needed to reach conclusive results. Our meta-analysis of observational studies suggests that local anaesthesia for carotid endarterectomy may be associated with lower peri-operative morbidity and mortality compared with general anaesthesia. Although randomised studies have not confirmed any advantage for local anaesthesia, this may be due to a lack of pooled statistical power in these trials.

What is the evidence for the use of biologic or biosynthetic meshes in abdominal wall reconstruction?

INTRODUCTION: Although many surgeons have adopted the use of biologic and biosynthetic meshes in complex abdominal wall hernia repair, others have questioned the use of these products. Criticism is addressed in several review articles on the poor standard of studies reporting on the use of biologic meshes for different abdominal wall repairs. The aim of this consensus review is to conduct an evidence-based analysis of the efficacy of biologic and biosynthetic meshes in predefined clinical situations. METHODS: A European working group, "BioMesh Study Group", composed of invited surgeons with a special interest in surgical meshes, formulated key questions, and forwarded them for processing in subgroups. In January 2016, a workshop was held in Berlin where the findings were presented, discussed, and voted on for consensus. Findings were set out in writing by the subgroups followed by consensus being reached. For the review, 114 studies and background analyses were used. RESULTS: The cumulative data regarding biologic mesh under contaminated conditions do not support the claim that it is better than synthetic mesh. Biologic mesh use should be avoided when bridging is needed. In inguinal hernia repair biologic and biosynthetic meshes do not have a clear advantage over the synthetic meshes. For prevention of incisional or parastomal hernias, there is no evidence to support the use of biologic/biosynthetic meshes. In complex abdominal wall hernia repairs (incarcerated hernia, parastomal hernia, infected mesh, open abdomen, enterocutaneous fistula, and component separation technique), biologic and biosynthetic meshes do not provide a superior alternative to synthetic meshes. CONCLUSION: The routine use of biologic and biosynthetic meshes cannot be recommended.

European Hernia Society guidelines on prevention and treatment of parastomal hernias.

BACKGROUND: International guidelines on the prevention and treatment of parastomal hernias are lacking. The European Hernia Society therefore implemented a Clinical Practice Guideline development project. METHODS: The guidelines development group consisted of general, hernia and colorectal surgeons, a biostatistician and a biologist, from 14 European countries. These guidelines conformed to the AGREE II standards and the GRADE methodology. The databases of MEDLINE, CINAHL, CENTRAL and the gray literature through OpenGrey were searched. Quality assessment was performed using Scottish Intercollegiate Guidelines Network checklists. The guidelines were presented at the 38th European Hernia Society Congress and each key question was evaluated in a consensus voting of congress participants. RESULTS: End colostomy is associated with a higher incidence of parastomal hernia, compared to other types of stomas. Clinical examination is necessary for the diagnosis of parastomal hernia, whereas computed tomography scan or ultrasonography may be performed in cases of diagnostic uncertainty. Currently available classifications are not validated; however, we suggest the use of the European Hernia Society classification for uniform research reporting. There is insufficient evidence on the policy of watchful waiting, the route and location of stoma construction, and the size of the aperture. The use of a prophylactic synthetic non-absorbable mesh upon construction of an end colostomy is strongly recommended. No such recommendation can be made for other types of stomas at present. It is strongly recommended to avoid performing a suture repair for elective parastomal hernia. So far, there is no sufficient comparative evidence on specific techniques, open or laparoscopic surgery and specific mesh types. However, a mesh without a hole is suggested in preference to a keyhole mesh when laparoscopic repair is performed. CONCLUSION: An evidence-based approach to the diagnosis and management of parastomal hernias reveals the lack of evidence on several topics, which need to be addressed by multicenter trials. Parastomal hernia prevention using a prophylactic mesh for end colostomies reduces parastomal herniation. Clinical outcomes should be audited and adverse events must be reported.