The effect of the COVID-19 pandemic on the mental health of obstetrics and gynaecology trainees: a world-wide literature review.

BACKGROUND: Coronavirus (COVID-19) pandemic has affected the training and wellbeing of obstetrics and gynaecology (O&G) trainees. The aim of this review is to offer a worldwide overview on its' impact on the mental health of O&G trainees, so that measures can be put into place to better support trainees during the transition back to the 'new normal'. METHODS: Key search terms used on PubMed and Google Scholar databases include: mental health, COVID-19, O&G, trainees, residents. RESULTS: Fifteen articles (cumulative number of respondents = 3230) were identified, of which eight employed validated questionnaires (n = 1807 respondents), while non-validated questionnaires were used in seven (n = 1423 respondents). Studies showed that COVID-19 appeared to exert more of a negative impact on females and on senior trainees' mental health, while protective factors included marriage/partner and having had children. Validated and non-validated questionnaires suggested that trainees were exposed to high levels of anxiety and depression. Their mental health was also affected by insomnia, stress, burnout and fear of passing on the virus. DISCUSSION: This review analyses the global impact of COVID-19 on O&G trainees' mental health, showing a pervasive negative effect linked to fear of the virus. Limited psychological support has led to prolonged issues, hindering patient safety and increasing sick leave. The study underscores the urgency of comprehensive support, particularly in female-dominated fields. Addressing these challenges is crucial for future pandemics, highlighting the need to learn from past mistakes and prioritise mental health resources for trainee well-being during and beyond pandemics.

This review provides a worldwide overview of the impact Coronavirus (COVID-19) pandemic on the mental health of obstetrics and gynaecology (O&G) trainees. Fifteen articles were identified, of which eight employed validated questionnaires (n = 1807 respondents), while non-validated questionnaires were used in seven (n = 1423 respondents). The pandemic appeared to exert more of a negative impact on females and on senior trainees' mental health, while protective factors included marriage/partner and having had children. Studies suggested that trainees were exposed to high levels of anxiety and depression. Their mental health was also affected by insomnia, stress, burnout and fear of passing on the virus.Limited psychological support has led to prolonged recovery issues and increasing sick leave. The study underscores the urgency of comprehensive support, particularly in female-dominated fields. Addressing these challenges is crucial for future pandemics, highlighting the need to learn from past mistakes and prioritise mental health resources for trainee well-being.

Volume-outcome relationships in open and endovascular repair of abdominal aortic aneurysm: administrative data 2006-2018.

BACKGROUND: The aim of this study was to use recent evidence to investigate and update volume-outcome relationships after open surgical repair (OSR) and endovascular repair (EVAR) of abdominal aortic aneurysm in England. METHODS: Hospital Episode Statistics (HES) data from April 2006 to March 2018 were obtained. The primary outcome was in-hospital death. Other outcomes included duration of hospital stay, readmissions within 30 days, and critical care requirements. Case-mix adjustment included age, sex, HES year, deprivation index, weekend admission, mode of admission, type of procedure and co-morbidities. RESULTS: Annual volume of all repairs combined appeared to be an appropriate measure of volume. After case-mix adjustment, a significant relationship between volume and in-hospital mortality was seen for OSR (P < 0·001) but not for EVAR (P = 0·169 for emergency and P = 0·363 for elective). The effect appeared to extend beyond 60 repairs per year to volumes above 100 repairs per year. There was no significant relationship between volume and duration of hospital stay or 30-day readmissions. In patients receiving emergency OSR, higher volume was associated with longer stay in critical care. CONCLUSION: Higher annual all-procedure volumes were associated with significantly lower in-hospital mortality for OSR, but such a relationship was not significant for EVAR. There was not enough evidence for a volume effect on other outcomes.

Electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS): development and validity.

BACKGROUND: This paper describes the development and validation of an electronic personal assessment questionnaire for vascular conditions (ePAQ-VAS) that captures the symptomatology, quality of life and clinically relevant data of patients presenting to vascular services. METHODS: A two-stage survey was conducted in patients attending a tertiary vascular department. Patients completed the ePAQ-VAS remotely online, or on site using an electronic tablet. In the first stage of the survey, the responses were used to perform confirmatory factor analysis to assess the construct validity and remove redundant items. The internal reliability of disease-specific scales was investigated. In the second stage of the survey, the acceptability, known-group validity, test-retest reliability, and responsiveness of ePAQ-VAS was assessed. RESULTS: In total, 721 patients completed ePAQ-VAS. Their mean(s.d.) age was 63·5(15·7) years and 468 (64·9 per cent) were men. Some 553 patients (76·7 per cent) completed the questionnaire in clinic and the remainder completed the questionnaire online. The results of the confirmatory factor analysis confirmed the conceptual model for ePAQ-VAS structure and eliminated six items. Internal reliability was acceptable for all the scales (Cronbach's α greater than 0·7). The test-retest reliability measured by the intraclass correlation coefficient ranged from 0·65 to 0·99. The results showed that the instrument was responsive over time with the standardized response mean ranging from 0·69 to 1·60. CONCLUSION: ePAQ-VAS is a holistic data-collection process that is relevant to vascular service users and has potential to contribute to patient-focused care and the collection of aggregate data for service evaluation. A demonstration version of the final version of ePAQ can be viewed at http://demo-questionnaire.epaq.co.uk/home/project?id=VASC_1.7&page=1.

ANTECEDENTES: Este artículo describe el desarrollo y la validación de un cuestionario electrónico de evaluación personal para enfermedades vasculares (ePAQ-VAS) que incluye la sintomatología, la calidad de vida y los datos clínicamente relevantes para los pacientes que son atendidos en los servicios de patología vascular. MÉTODOS: Se llevó a cabo una encuesta en dos fases entre los pacientes atendidos en un servicio de patología vascular de tercer nivel. Los pacientes completaron el cuestionario ePAQ-VAS a distancia en línea o bien en el centro hospitalario mediante una tableta electrónica. En la primera fase de la encuesta, las respuestas se utilizaron para realizar un análisis factorial de confirmación para evaluar la validez del diseño y eliminar los elementos redundantes. Se investigó la fiabilidad interna de las escalas específicas de la enfermedad. En la segunda fase de la encuesta, se evaluó la aceptabilidad, la validez de grupo conocida, la fiabilidad test-retest y la capacidad de respuesta del ePAQ-VAS. RESULTADOS: En total, 721 pacientes completaron el ePAQ-VAS, la edad media fue de 63,5 años (DE 15,7); el 64,9% eran varones (468); el 76% de los pacientes (553) completaron el cuestionario en la clínica y los pacientes restantes lo hicieron electrónicamente a distancia. Los resultados del análisis factorial de confirmación confirmaron el modelo conceptual para la estructura ePAQ-VAS y eliminaron seis ítems. La fiabilidad interna fue aceptable para todas las escalas (alfa de Cronbach > 0,7). La fiabilidad test-retest medida por el coeficiente de correlación intraclase osciló entre 0,65-0,99. Los resultados mostraron que el instrumento responde con el tiempo con una media de respuesta estandarizada que varía de 0,69 a 1,60. CONCLUSIÓN: El ePAQ-VAS es un proceso holístico de recopilación de datos que es relevante para los usuarios de servicios de patología vascular y tiene el potencial de contribuir a la atención centrada en el paciente y a la recopilación de datos agregados para la evaluación del servicio.

Strength of public preferences for endovascular or open aortic aneurysm repair.

BACKGROUND: This study evaluated public preferences for the treatment processes for abdominal aortic aneurysm repair in order to allow them to be incorporated into a cost-effectiveness analysis. METHODS: This was a telephone survey using a trade-off method in UK resident adults (aged at least 18 years) with no previous diagnosis of a vascular condition. RESULTS: Some 167 of 209 participants (79·9 per cent) stated that they would prefer endovascular aneurysm repair (EVAR), 40 (19·1 per cent) preferred open surgery and two (1·0 per cent) stated no preference. Participants preferred EVAR because of the less invasive nature of the intervention and quicker recovery. Participants preferring open surgery cited reasons such as having a single follow-up appointment, and a procedure that felt more permanent. When participants were asked to make a sacrifice in order to have their preferred treatment, 122 (58·4 per cent) favoured EVAR, 18 (8·6 per cent) favoured open surgery and 69 (33·0 per cent) had no preference. Those preferring EVAR were willing to give up a mean of 0·135 expected quality-adjusted life-years (QALYs) to have EVAR, compared with a willingness to give up 0·033 expected QALYs among those preferring open repair. CONCLUSION: These results indicate a clear preference for EVAR over open surgery for aortic aneurysm.

ANTECEDENTES: Este estudio evaluó las preferencias de la opinion pública en relación a las opciones de tratamiento para la reparación del aneurisma de aorta abdominal, con el objetivo de que dichas preferencias se puedan incorporar en un análisis de coste-efectividad. MÉTODOS: Se realizó una encuesta telefónica utilizando el método trade-off (solución de intercambio) en adultos residentes en el Reino Unido (mayores de 18 años) sin diagnóstico previo de enfermedad vascular. RESULTADOS: Un total de 167 (79,9%) de 209 participantes declararon que preferirían la reparación endovascular del aneurisma (endovascular aneurysm repair, EVAR), 40 (19,1%) prefirieron cirugía abierta y dos (1,0%) no tenían preferencia. Los participantes prefirieron el EVAR debido a la naturaleza menos invasiva de la intervención y a tiempos de recuperación más rápidos. Los participantes que preferían la cirugía abierta mencionaron como razones tener una única visita de seguimiento y consideraron que se trataba de un procedimiento más permanente. Cuando se pidió a los participantes que para recibir su tratamiento preferido hicieran un intercambio, 122 (58,4%) se decantaron por la EVAR, 18 (8,6%) por la cirugía abierta y 69 (33%) no tuvieron preferencia. Los que prefirieron EVAR estaban dispuestos a renunciar a una media de 0,135 años de vida ajustados por calidad (QALYs) esperados con tal de recibir una EVAR en comparación con la renuncia de 0,033 QALYs esperada entre quienes preferían la reparación abierta. CONCLUSIÓN: Estos resultados indican una clara preferencia por la EVAR sobre la cirugía abierta, lo que está en desacuerdo con la reciente recomendación de NICE de que la EVAR no debe recomendarse como una opción de tratamiento. Los hallazgos sugieren que se debe prestar mayor atención a las características del proceso de tratamiento. Al no incorporar explícitamente tales preferencias en el proceso de toma de decisiones, NICE corre el riesgo de recomendar opciones de tratamiento que son contrarias a las preferencias de la población del Reino Unido.

Sex differences in national rates of repair of emergency abdominal aortic aneurysm.

BACKGROUND: The aim of this study was to assess the sex differences in both the rate and type of repair for emergency abdominal aortic aneurysm (AAA) in England. METHODS: Hospital Episode Statistics (HES) data sets from April 2002 to February 2015 were obtained. Clinical and administrative codes were used to identify patients who underwent primary emergency definitive repair of ruptured or intact AAA, and patients with a diagnosis of AAA who died in hospital without repair. These three groups included all patients with a primary AAA who presented as an emergency. Sex differences between repair rates and type of surgery (endovascular aneurysm repair (EVAR) versus open repair) over time were examined. RESULTS: In total, 15 717 patients (83·3 per cent men) received emergency surgical intervention for ruptured AAA and 10 276 (81·2 per cent men) for intact AAA; 12 767 (62·0 per cent men) died in hospital without attempted repair. The unadjusted odds ratio for no repair in women versus men was 2·88 (95 per cent c.i. 2·75 to 3·02). Women undergoing repair of ruptured AAA were older and had a higher in-hospital mortality rate (50·0 versus 41·0 per cent for open repair; 30·9 versus 23·5 per cent for EVAR). After adjustment for age, deprivation and co-morbidities, the odds ratio for no repair in women versus men was 1·34 (1·28 to 1·40). The in-hospital mortality rate after emergency repair of an intact AAA was also higher among women. CONCLUSION: Women who present as an emergency with an AAA are less likely to undergo repair than men. Although some of this can be explained by differences in age and co-morbidities, the differences persist after case-mix adjustment.

Supervised exercise training as an adjunct therapy for venous leg ulcers: a randomized controlled feasibility trial.

BACKGROUND: Venous leg ulcers (VLUs) are typically painful and heal slowly. Compression therapy offers high healing rates; however, improvements are not usually sustained. Exercise is a low-cost, low-risk and effective strategy for improving physical and mental health. Little is known about the feasibility and efficacy of supervised exercise training used in combination with compression therapy patients with VLUs. OBJECTIVES: To assess the feasibility of a 12-week supervised exercise programme as an adjunct therapy to compression in patients with VLUs. METHODS: This was a two-centre, two-arm, parallel-group, randomized feasibility trial. Thirty-nine patients with venous ulcers were recruited and randomized 1 : 1 either to exercise (three sessions weekly) plus compression therapy or compression only. Progress/success criteria included exercise attendance rate, loss to follow-up and patient preference. Baseline assessments were repeated at 12 weeks, 6 months and 1 year, with healing rate and time, ulcer recurrence and infection incidents documented. Intervention and healthcare utilization costs were calculated. Qualitative data were collected to assess participants' experiences. RESULTS: Seventy-two per cent of the exercise group participants attended all scheduled exercise sessions. No serious adverse events and only two exercise-related adverse events (both increased ulcer discharge) were reported. Loss to follow-up was 5%. At 12 months, median ulcer healing time was lower in the exercise group (13 vs. 34·7 weeks). Mean National Health Service costs were £813·27 for the exercise and £2298·57 for the control group. CONCLUSIONS: The feasibility and acceptability of both the supervised exercise programme in conjunction with compression therapy and the study procedures is supported.

Sex differences in mortality after abdominal aortic aneurysm repair in the UK.

BACKGROUND: The UK abdominal aortic aneurysm (AAA) screening programmes currently invite only men for screening because the benefit in women is uncertain. Perioperative risk is critical in determining the effectiveness of screening, and contemporary estimates of these risks in women are lacking. The aim of this study was to compare mortality following AAA repair between women and men in the UK. METHODS: Anonymized data from the UK National Vascular Registry (NVR) for patients undergoing AAA repair (January 2010 to December 2014) were analysed. Co-variables were extracted for analysis by sex. The primary outcome measure was in-hospital mortality. Secondary outcome measures included mortality by 5-year age groups and duration of hospital stay. Logistic regression was performed to adjust for age, calendar time, AAA diameter and smoking status. NVR-based outcomes were checked against Hospital Episode Statistics (HES) data. RESULTS: A total of 23 245 patients were included (13·0 per cent women). Proportionally, more women than men underwent open repair. For elective open AAA repair, the in-hospital mortality rate was 6·9 per cent in women and 4·0 per cent in men (odds ratio (OR) 1·48, 95 per cent c.i. 1·08 to 2·02; P = 0·014), whereas for elective endovascular AAA repair it was 1·8 per cent in women and 0·7 per cent in men (OR 2·86, 1·72 to 4·74; P < 0·001); the results in HES were similar. For ruptured AAA, there was no sex difference in mortality within the NVR; however, in HES, for ruptured open AAA repair, the in-hospital mortality rate was higher in women (33·6 versus 27·1 per cent; OR 1·36, 1·16 to 1·59; P < 0·001). CONCLUSION: Women have a higher in-hospital mortality rate than men after elective AAA repair even after adjustment. This higher mortality may have an impact on the benefit offered by any screening programme offered to women.

Systematic review of patient-reported outcome measures in patients with varicose veins.

BACKGROUND: Varicose veins can affect quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient about the impact of the disease without interpretation from clinicians or anyone else. The aim of this study was to examine the quality of the psychometric evidence for PROMs used in patients with varicose veins. METHODS: A systematic review was undertaken to identify studies that reported the psychometric properties of generic and disease-specific PROMs in patients with varicose veins. Literature searches were conducted in databases including MEDLINE, up to July 2016. The psychometric criteria used to assess these studies were adapted from published recommendations in accordance with US Food and Drug Administration guidance. RESULTS: Nine studies were included which reported on aspects of the development and/or validation of one generic (36-Item Short Form Health Survey, SF-36®) and three disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ; Varicose Veins Symptoms Questionnaire, VVSymQ®; Specific Quality-of-life and Outcome Response - Venous, SQOR-V) PROMs. The evidence from included studies provided data to support the construct validity, test-retest reliability and responsiveness of the AVVQ. However, its content validity, including weighting of the AVVQ questions, was biased and based on the opinion of clinicians, and the instrument had poor acceptability. VVSymQ® displayed good responsiveness and acceptability rates. SF-36® was considered to have satisfactory responsiveness and internal consistency. CONCLUSION: There is a scarcity of psychometric evidence for PROMs used in patients with varicose veins. These data suggest that AVVQ and SF-36® are the most rigorously evaluated PROMs in patients with varicose veins.

Systematic review of carotid artery procedures and the volume-outcome relationship in Europe.

BACKGROUND: Hospitals that conduct more procedures on the carotid arteries may achieve better outcomes. In the context of ongoing reconfiguration of UK vascular services, this systematic review was conducted to evaluate the relationship between the volume of carotid procedures and outcomes, including mortality and stroke. METHODS: Searches of electronic databases identified studies that reported the effect of hospital or clinician volume on outcomes. Reference and citation searches were also performed. Inclusion was restricted to European populations on the basis that the model of healthcare delivery is similar across Europe, but differs from that in the USA and elsewhere. Analyses of hospital and clinician volume, and carotid endarterectomy (CEA) and carotid artery stenting (CAS) were conducted separately. RESULTS: Eleven eligible studies were identified (233 411 participants), five from the UK, two from Sweden, one each from Germany, Finland and Italy, and a combined German, Austrian and Swiss population. All studies were observational. Two large studies (179 736 patients) suggested an inverse relationship between hospital volume and mortality (number needed to treat (NNT) as low as 165), and combined mortality and stroke (NNT as low as 93), following CEA. The evidence was less clear for CAS; multiple analyses in three studies did not identify convincing evidence of an association. Limited data are available on the relationship between clinician volume and outcome in CAS; in CEA, an inverse relationship was identified by two of three small studies. CONCLUSION: The evidence from the largest and highest-quality studies included in this review support the centralization of CEA.

Systematic review and qualitative evidence synthesis of patient-reported outcome measures for abdominal aortic aneurysm.

BACKGROUND: The aim was to identify and evaluate existing patient-reported outcome measures (PROMs) for use in patients with an abdominal aortic aneurysm (AAA) to inform the selection for use in surgical practice. METHODS: Two reviews were conducted: a systematic review to identify valid, reliable and acceptable PROMs for patients with an AAA, and a qualitative evidence synthesis to assess the relevance to patients of the identified PROM items. PROM studies were evaluated for their psychometric properties using established assessment criteria, and for their methodological quality using the COSMIN checklist. Qualitative studies were synthesized using framework analysis, and concepts identified were then triangulated using a protocol with the item concepts of the identified PROMs. RESULTS: Four PROMs from three studies were identified in the first review: Short Form 36, Australian Vascular Quality of Life Index, Aneurysm Dependent Quality of Life (AneurysmDQoL) and Aneurysm Symptoms Rating Questionnaire (AneurysmSRQ). None of the identified PROMs had undergone a rigorous psychometric evaluation within the AAA population. Four studies were included in the qualitative synthesis, from which 28 concepts important to patients with an AAA were identified. The AneurysmDQoL and AneurysmSRQ together provided the most comprehensive assessment of these concepts. Fear of rupture, control, ability to forget about the condition and size of aneurysm were all concepts identified in the qualitative studies but not covered by items in the identified PROMs. CONCLUSION: Further research is needed to develop PROMs for AAA that are reliable, valid and acceptable to patients.

Procedure Volume and the Association with Short-term Mortality Following Abdominal Aortic Aneurysm Repair in European Populations: A Systematic Review.

OBJECTIVE: To evaluate the relationship between the volume of abdominal aortic aneurysm (AAA) procedures undertaken and the primary outcome of mortality in Europe. Previous systematic reviews of this relationship are outdated and are overwhelmingly based on US data. DATA SOURCES: Comprehensive searching within MEDLINE and other bibliographic databases supplemented by citation searching and hand-searching of journals was undertaken to identify studies that reported the effect of hospital or clinician volume on any reported outcomes in adult, European populations, undergoing AAA repair and published in the last 10 years. METHODS: Two reviewers conducted study selection with independent, duplicate data extraction and quality assessment. A planned meta-analysis was not conducted because of the high risk of bias, the likelihood of individual study subjects being included in more than one study and diversity in the clinical populations studied and methods used. RESULTS: Sixteen studies (n = 237,074 participants) from the UK (n = 11 studies), Germany (n = 3 studies), Norway (n = 1 study), and one from the UK and Sweden were included. Data in the included studies came from administrative databases and clinical registries incorporating a variety of clinical and procedural groups; the study quality was limited by the use of observational study designs. Overall, the evidence favoured the existence of an inverse volume outcome relationship between hospital volume and mortality. Insufficient evidence was available to reach conclusions on the relationship between clinician volume and outcome and between hospital or clinician volume and secondary outcomes including complications and length of hospital stay. CONCLUSIONS: The evidence from this review suggests a relationship between the hospital volume of AAA procedures conducted and short-term mortality; however, as volume typically represents a complex amalgamation of factors further research will be useful to identify the core characteristics of volume that influence improved outcomes.

Systematic review, network meta-analysis and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins.

BACKGROUND: A Health Technology Assessment was conducted to evaluate the relative clinical effectiveness and cost-effectiveness of minimally invasive techniques (foam sclerotherapy (FS), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA)) for managing varicose veins, in comparison with traditional surgery. METHODS: A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of minimally invasive techniques compared with other treatments, principally surgical stripping, in terms of recurrence of varicose veins, Venous Clinical Severity Score (VCSS), pain and quality of life. Network meta-analysis and exploratory cost-effectiveness modelling were performed. RESULTS: The literature search conducted in July 2011 identified 1453 unique citations: 31 RCTs (51 papers) satisfied the criteria for effectiveness review. Differences between treatments were negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be most cost-effective. Total FS costs were estimated to be lowest, and FS was marginally more effective than surgery. However, relative effectiveness was sensitive to the model time horizon. Threshold analysis indicated that EVLA and RFA might be considered cost-effective if their costs were similar to those for surgery. These findings are subject to various uncertainties, including the risk of bias present in the evidence base and variation in reported costs. CONCLUSION: This assessment of currently available evidence suggests there is little to choose between surgery and the minimally invasive techniques in terms of efficacy or safety, so the relative cost of the treatments becomes one of the deciding factors. High-quality RCT evidence is needed to verify and further inform these findings.

Systematic review and meta-analysis of additional technologies to enhance angioplasty for infrainguinal peripheral arterial occlusive disease.

BACKGROUND: There are several additional techniques designed to enhance conventional percutaneous transluminal balloon angioplasty (PTA). This systematic review assessed current evidence on the clinical effectiveness of additional techniques for infrainguinal peripheral arterial occlusive disease (PAD). METHODS: Relevant electronic databases, including MEDLINE, were searched in May 2011. The population comprised participants with symptomatic PAD undergoing endovascular treatment for disease distal to the inguinal ligament. Interventions were additional techniques compared with conventional PTA. Main outcome measures were restenosis and need for reintervention. Randomized clinical trials (RCTs) of clinical effectiveness were assessed for quality and data were extracted. Where appropriate, meta-analysis was undertaken to produce risk ratios (RRs). RESULTS: Forty RCTs were selected. Meta-analysis showed a significant benefit in reducing restenosis rates at 6 months for self-expanding stents (RR 0.49) and drug-coated balloons (RR 0.40), and at 12 months for endovascular brachytherapy (RR 0.63). There was also evidence that use of a stent-graft significantly reduced restenosis compared with PTA, as did drug-eluting stents compared with bare-metal stents. Meta-analysis showed that use of drug-coated balloons was associated with significantly lower reintervention rates than PTA alone at 6 months (RR 0.24) and 24 months (RR 0.27) of follow-up. There was also evidence of significantly lower reintervention rates for self-expanding stents at 6 months. Other techniques did not show significant treatment effects for restenosis or reintervention. CONCLUSION: The conclusions of this review should be tempered by small sample sizes, lack of clinical outcome measures and differing outcome definitions, making direct comparison across trials difficult. However, self-expanding stents, drug-eluting stents and drug-coated balloons appeared to be the most promising technologies worthy of future study.

Cost-effectiveness analysis of enhancements to angioplasty for infrainguinal arterial disease.

BACKGROUND: The aim was to perform an economic evaluation of the cost-effectiveness of endovascular enhancements to percutaneous transluminal balloon angioplasty (PTA) with bail-out bare metal stents for infrainguinal peripheral arterial disease. METHODS: The following interventions were considered: PTA with no bail-out stenting, PTA with bail-out drug-eluting stents, drug-coated balloons, primary bare metal stents, primary drug-eluting stents, endovascular brachytherapy, stent-grafts and cryoplasty. A discrete-event simulation model was developed to assess the relative cost-effectiveness of the interventions from a health service perspective over a lifetime. Populations of patients with intermittent claudication (IC) and critical leg ischaemia (CLI) were modelled separately. Univariable and probabilistic sensitivity analyses were undertaken. Effectiveness was measured by quality-adjusted life-years (QALYs). RESULTS: For both patient populations, the use of drug-coated balloons dominated all other options by having both lower lifetime costs and greater effectiveness. For willingness-to-pay thresholds between £0 and £100,000 per additional QALY, the probability of drug-coated balloons being cost-effective was at least 58.3 per cent for patients with IC and at least 72.2 per cent for patients with CLI. Sensitivity analyses showed that the results were robust to different assumptions regarding the clinical benefits attributable to the interventions. CONCLUSION: The use of drug-coated balloons represents a cost-effective alternative to the use of PTA with bail-out bare metal stents.

The cost-effectiveness of supervised exercise for the treatment of intermittent claudication.

BACKGROUND: Supervised exercise (SE) is thought to result in improvements in walking distance and quality of life compared with unsupervised exercise (USE) in people with intermittent claudication. However, the cost-effectiveness of SE is unclear. As a result, many patients are currently unable to access supervised programmes. METHODS: We searched MEDLINE, Embase, Cochrane, and Cinahl databases to identify randomised controlled trials comparing USE with SE in adults with intermittent claudication. A Markov model was developed to estimate costs and quality adjusted life years (QALYs) from an NHS and personal social services perspective. Quality of life was obtained from the included clinical trials. Resource use was modelled on current programmes and unit costs were based on published sources. RESULTS: Depending on estimated rates of compliance, SE was cost-effective in over 75% of model simulations, with an incremental cost-effectiveness ratio of £711 to £1,608 per QALY gained. The model was sensitive to long-term effects of exercise on cardiovascular risk and quality of life. CONCLUSIONS: SE is more cost-effective than USE for the treatment of people with intermittent claudication. Supervised programmes should be made widely available and offered as a first line treatment to people with intermittent claudication.

Indeterminate thyroid nodules (Thy3): malignancy rate and characteristics in a study of 118 patients.

INTRODUCTION: Thyroid nodules are common, and the combined use of ultrasound and fine needle aspiration cytology provides useful information on their malignancy risk. The Thy reporting system is widely used in the United Kingdom, with malignancy rates for Thy3 cytology being quoted between 5% and 30%. This study aims to establish the risk of thyroid cancer in operated patients with Thy3 cytology and correlate it with patient demographics and nodule size. METHODS: This is a retrospective observational study of all thyroidectomies that took place in a single institution over a 3-year period (2019-2022). Those with a preoperative cytology of Thy3 were analysed further and in particular, nodule size, final histology and patients' demographics were documented. RESULTS: Some 260 thyroidectomies were performed during the study period. Of these, 118 patients had Thy3 cytology. In the Thy3a group (n = 70), the malignancy rate was 27.1%. The average age of those with thyroid cancer was 51.4 vs 51.2 years for those with benign disease. The nodule size was under 40mm for both groups (36mm vs 39.7mm). In the Thy3f group (n = 48), the malignancy rate was 43.8%. The average age of those with thyroid cancer was 53.5 vs 56.2 years for those with benign disease. The nodule size was similar (24.5mm vs 27.6mm). CONCLUSIONS: In this study, one in three patients with Thy3 cytology was diagnosed with thyroid cancer. We urge local units to analyse their data, to aid patients' informed decision-making. Within the subgroups, there was no significant difference in average nodule size or patients' age.

Systematic review of the efficacy of cilostazol, naftidrofuryl oxalate and pentoxifylline for the treatment of intermittent claudication.

BACKGROUND: A systematic review and network meta-analysis was undertaken to consider the evidence for the efficacy and tolerability of placebo, cilostazol, naftidrofuryl oxalate and pentoxifylline in patients with intermittent claudication due to peripheral arterial disease (PAD). METHODS: MEDLINE, Embase, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Web of Science, Conference Proceedings, BIOSIS, National Research Register and MetaRegister databases were searched. Eligible studies were randomized controlled trials (RCTs) and published systematic reviews of patients with intermittent claudication due to PAD and whose symptoms persisted despite a period of conservative management. Study selection was conducted by one reviewer with involvement from a clinician. Data were extracted by one reviewer with no blinding to authors or journal, and checked by a second reviewer. Outcome measures were maximum walking distance (MWD) and pain-free walking distance (PFWD). RESULTS: The review identified 1876 citations; 26 RCTs met the inclusion criteria for the systematic review. Eleven trials provided data relevant for the meta-analysis. Naftidrofuryl oxalate was ranked first for both MWD and PFWD (probability of 0·947 and 0·987, respectively, of being the best treatment) followed by cilostazol and pentoxifylline. For naftidrofuryl oxalate, cilostazol and pentoxifylline, MWD increased by 60 (95 per cent credible interval 20 to 114) per cent, 25 (11 to 40) per cent and 11 (-1 to 24) per cent respectively relative to placebo, and PFWD increased by 49, 13 and 9 per cent. CONCLUSION: Naftidrofuryl oxalate and cilostazol are both effective treatments for claudication; naftidrofuryl oxalate is likely to be the most effective, with minimal serious adverse events.

Results of computer-assisted sensory evaluation in 41 patients with erythromelalgia.

BACKGROUND: Erythromelalgia is a rare disorder characterized by the clinical syndrome of burning pain, warmth and redness of the limbs. Neurological abnormalities (both large- and small-fibre neuropathy) are common. There have been few published reports on the sensory status of patients with erythromelalgia. AIM: To investigate the results of quantitative sensation testing in erythromelalgia using computer-assisted sensory evaluation, including vibratory detection threshold, cool detection threshold and heat-pain threshold (HPT). METHODS: Patients who underwent dermatological or neurological evaluation of suspected erythromelalgia at our institution and received a final diagnosis of erythromelalgia were identified from a master diagnosis index covering the period January 1994 to June 2008. A retrospective chart review was performed. Main outcome measures were sensory abnormalities (e.g. pain, burning sensation, tingling) in response to heat, cooling and vibration during computer-assisted sensory testing. RESULTS: In total, 41 patients with erythromelalgia were enrolled in the study and underwent computer-assisted sensory evaluation. Of these, 34 patients (82.9%) had abnormal results. The commonest abnormality was isolated HPT: 11 patients (26.8%) had heat hypoalgesia and 18 (43.9%) had heat hyperalgesia, whereas only 2 (4.9%) of the healthy control patients had hyperalgesia on testing. CONCLUSIONS: Multiple sensory modalities were found to be abnormal in patients with erythromelalgia, with the commonest clinical abnormality being isolated heat-pain abnormality. These findings lend support to the notion that neuropathy underlies the clinical diagnosis of erythromelalgia. Future studies will explore the nature of the relationship between these sensory abnormalities and the clinical features of erythromelalgia.