Current opinion on large-scale prospective myomectomy databases toward evidence-based preconception and antenatal counselling utilising a standardised myomectomy operation note.

Background: No large-scale databases exist of pregnancy outcomes and rate of uterine rupture for women after myomectomy, resulting in inconsistent antenatal counselling and decision-making regarding mode and timing of delivery. Standardising information collected at myomectomy may facilitate data collection, informing prenatal/ antenatal counselling. Objectives: To determine clinician opinions regarding standardisation of myomectomy operation notes to allow comprehensive data input into a prospective database of pregnancy outcomes, toward an evidence-based approach to decision making regarding timing and mode of delivery in subsequent pregnancies. Materials and Methods: A google forms survey was emailed to all consultant (attending-level) obstetricians and gynaecologists across 25 hospitals in London, Kent, Surrey, and Sussex (UK) between March and May 2022. To enhance response rates, two further email reminders were sent alongside in-person reminders from selected local unit representatives. Main outcome measures: Senior clinician opinion for characteristics necessary to collect at time of surgery to develop a widescale database of post myomectomy pregnancy outcomes. Results: 209/475 (44%) responses received; 95% (198/209) agreed with standardising operation notes. Criteria selected for inclusion included cavity breach (98%, 194/198), location (98%, 194/198), number of fibroids removed (93%, 185/198) and number of uterine incisions (96%, 190/198). Conclusions: Gynaecologists support standardising myomectomy operation notes to inform the development of prospective large-scale databases of pregnancy outcomes after myomectomy. What is new?: Acquisition of clinician opinions on the development and content of a standardised myomectomy operation note to aid the development of a pregnancy-outcome database for women after myomectomy.

Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies - impact of drug packaging and administration method on patient reported outcomes.

BACKGROUND: Here, the perspective of patients with primary and secondary immunodeficiency receiving subcutaneous immunoglobulin (SCIg) via introductory smaller size pre-filled syringes (PFS) or vials were compared. METHODS: An online survey was conducted in Canada by the Association des Patients Immunodéficients du Québec (APIQ) (10/2020-03/2021). Survey questions included: reasons for choosing SCIg packaging and administration methods, training experiences, infusion characteristics, and switching methods. The survey captured structured patient-reported outcomes: treatment satisfaction and its sub-domains, symptom state, general health perception, and physical and mental function. Respondents using PFS were compared with vial users, overall and stratified by their administration method (pump or manual push). RESULTS: Of the 132 total respondents, 66 respondents used vials, with 38 using a pump and 28 using manual push. PFS (5 and 10 mL sizes) were being used by 120 respondents, with 38 using a pump and 82 using manual push. PFS users were associated with a 17% lower median (interquartile range) SCIg dose (10 [8, 12] vs. 12 [9, 16] g/week, respectively), a significantly shorter infusion preparation time (15 [10, 20] vs. 15 [10, 30] mins, respectively), and a trend for shorter length of infusion (60 [35, 90] vs. 70 [48, 90] mins, respectively) compared with those on vials. Patient-reported treatment satisfaction scores were overall similar between vial and PFS users (including on the domains of effectiveness and convenience), except for a higher score for vials over PFS on the domain of global satisfaction (p=0.02). CONCLUSIONS: Consistent with prescribing that reflects a recognition of less wastage, PFS users were associated with a significantly lower SCIg dose compared with vial users. PFS users were also associated with shorter pre-infusion times, reflecting simpler administration mechanics compared with vial users. Higher global satisfaction with treatment among vial users compared with PFS users was consistent with users being limited to smaller PFS size options in Canada during the study period. Patient experience on PFS is expected to improve with the introduction of larger PFS sizes. Overall, treatment satisfaction for SCIg remains consistently high with the introduction of PFS packaging compared with vials.

Should we abandon hormonal therapy in endometrial cancer? Outcomes of recurrent and metastatic endometrial cancer treated with systemic progestins.

PURPOSE: The objective of this study is to determine primary survival endpoints in women with recurrent and metastatic endometrial carcinoma (RMEC) treated with progestins. METHODS: A retrospective chart review was conducted at The Ottawa Hospital using electronic medical records. Inclusion criteria were a diagnosis of RMEC between 2000 and 2019, endometrioid histology, and ≥one line of progestin treatment. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. RESULTS: Of 2342 cases reviewed, 74 met inclusion criteria. Sixty-six (88.0%) patients received megestrol acetate and 9 (12.0%) received a progestin alternative. The distribution of tumors by grade was: 1: 25 (33.3%), 2: 30 (40.0%), and 3: 20 (26.7%). The PFS and OS for the entire study sample was 14.3 months (95% CI 6.2-17.9) and 23.3 months (14.8-36.8), respectively. The PFS for patients with Grade 1-2 RMEC was 15.7 months (8.0, 19.5), compared to 5.0 months (3.0, 23.0) with Grade 3 disease. The OS for patients with Grade 1-2 versus Grade 3, was 25.9 months (15.3, 40.3) versus 12.5 months (5.7, 35.9), respectively. Thirty-four (45.9%) and 40 (54.1%) patients were treated with 0 and ≥1 line of chemotherapy. The PFS for chemotherapy-naïve patients was 17.9 months (14.3, 27.0), versus 6.2 months (3.9, 14.8) following ≥1 line of treatment. The OS was 29.1 months (17.9, 61.1) for chemotherapy-naïve patients versus 23.0 months (10.5, 37.6) for patients previously exposed. CONCLUSIONS: This real-world data on RMEC suggests there is a role for progestins in select subgroups of women. The PFS for chemotherapy-naïve patients was 17.9 months (14.3, 27.0), versus 6.2 months (3.9, 14.8) following ≥1 line of treatment. The OS was 29.1 months (17.9, 61.1) for chemotherapy-OS was 29.1 months (17.9, 61.1) for chemotherapy-naïve patients versus 23.0 months (10.5, 37.6) for patients previously exposed.

Towards a clinical consensus on the management of pregnancy and birth after laparoscopic and open myomectomy: A survey of obstetricians and gynaecologists.

OBJECTIVES: The primary aim was to assess if a clinical consensus regarding the management of pregnancy post myomectomy existed amongst consultant obstetricians and gynaecologists. Secondary objectives were to evaluate factors which influence the clinician's decision making in this group of women. STUDY DESIGN: Electronic survey sent to all consultants working in the North Central and East London deanery, Kent Surrey and Sussex deanery and Imperial NHS Trust to assess opinions on mode of birth post myomectomy, intervals advised to pregnancy post myomectomy, factors influencing the management of delivery in the scarred uterus post myomectomy, opinions on induction of labour and questions relating to operative notes. RESULTS: 209 consultant responses received between 07/03/2022-07/05/2022 (44% response rate); 77% (161/209) practicing obstetricians and gynaecologists, 10% (21/109) pure gynaecologists and 13% (27/209) pure obstetricians. The majority would support a vaginal birth after open myomectomy (75%) and laparoscopic myomectomy (79%). No consensus was found as to the optimal time interval between myomectomy and pregnancy. Higher frequency of performing myomectomy and a greater level of experience were significantly associated with a shorter interval to pregnancy advised. The most important operative factors influencing decision to support trial of labour post myomectomy were breach of uterine cavity; location of fibroids removed and number of incisions on the uterus. 77% believe women should be given a choice regarding mode of delivery post myomectomy in a similar way to previous LSCS. 82.8% would support enrolment of patients into a prospective trial to investigate delivery post myomectomy. CONCLUSIONS: We present a comprehensive survey of clinician opinions on pregnancy post myomectomy demonstrating that the majority of consultant obstetricians and gynaecologists sampled would support vaginal birth post myomectomy; counselling patients in a similar way to VBAC; a standardised myomectomy operation note and enrolment of patients in a future prospective trial. Wide variation in opinion regarding interval to pregnancy post myomectomy has been highlighted. We believe this information will facilitate counselling discussions and empower women with subsequent pregnancies after myomectomy to make an informed decision on mode of birth post myomectomy.

Prevalence of Pulmonary Hypertension in Chronic Kidney Disease.

Pulmonary hypertension is a common comorbidity in patients with chronic kidney disease and end-stage renal disease(CKD). The presence of pulmonary hypertension is associated with increased risk of hospitalization and mortality in patients with CKD. Review of literature showed that in one study, pulmonary hypertension was found in 40% of patients with end stage renal disease on chronic hemodialysis therapy via arteriovenous access. The presence of CKD was associated with 1.4-fold increased risk of having pulmonary hypertension after adjusting for other independent risk factors for CKD. Preventing pulmonary hypertension in this population is crucial because even kidney transplantation may not reverse the high mortality associated with established pulmonary hypertension. MATERIAL: Place of study- Rajendra Institute of Medical Sciences, Ranchi. Design of study- Observational and prospective single centered study. Duration of study-18 months. Sample size-100 CKD patients admitted to department of medicine, RIMS, Ranchi. Study population-100 CKD patients meeting our inclusion criteria, admitted in the department of medicine, Rajendra Institute of Medical Sciences, Ranchi, between 1st January 2020 and 30th June 2021. INCLUSION CRITERIA: Renal function was determined by estimated glomerular filtration rate. Only patients with stage 3 or worse CKD were included. EXCLUSION CRITERIA: 1. Those patients having stage 2 or less kidney disease were excluded. 2. Patients with congenital heart disease, chronic thromboembolic disease, acute myocardial infarction and previous lung disease or cardiac transplantation were excluded. Data was collected by oral questionnaire, relevant investigations and by doing 2D- ECHO and data was analyzed by using IBM SPSS Statistics software. OBSERVATION: Prevalence of pulmonary hypertension in the study group was 16%. Prevalence of pulmonary hypertension was more in stage 5 CKD patients (26.19%) and the difference in prevalence of pulmonary hypertension in different stages of CKD was statistically significant(p value-0.008). Prevalence of pulmonary hypertension was more in patients on hemodialysis (27.78%) compared to those not on hemodialysis (9.37%). Pulmonary hypertension was present in 13.85% males and 20% of females, there was no statistically significant difference (p value-.428). No significant difference was found in prevalence of pulmonary hypertension between diabetic and non- diabetic patients and hypertensive and normotensive patients. CONCLUSION: Prevalence of pulmonary hypertension was more in stage 5 CKD patients and patients on hemodialysis. There was positive correlation between high serum creatinine, high serum phosphorus, lower hemoglobin, lower serum calcium and pulmonary hypertension in CKD patients. There was no significant difference in prevalence of pulmonary hypertension in male and female patients.

The impact of COVID-19 on O&G trainees; where are we now?

Background and Objectives: Obstetrics and Gynaecology (O&G) training continues to face challenges caused by the COVID-19 pandemic, particularly in gynaecological surgical training. This follow-up survey captures the ongoing effect on O&G trainees and highlights the future recovery plan considering the historical training gaps in benign gynaecology. Materials and Methods: an anonymised survey was emailed to all O&G trainees in Kent, Surrey and Sussex (KSS). Responses were collected over 6 weeks. Main Outcome Measures and Results: 53% of trainees responded. In total, 78% of trainees agreed that the pandemic had an ongoing negative effect on their physical and mental wellbeing respectively. Trainees felt the prior negative impact on obstetric training is improving, whilst 88% still experience a negative impact on their gynaecology surgical training despite the resumption of elective services in the National Health Service (NHS). 80% continue to feel the negative impact on their educational activities and 88% felt their overall training continues to be negatively impacted. 70% were positive that they would recover from this. Responses were representative of each training year. Interestingly, 95% of trainees had accepted the COVID vaccine. Conclusion: despite "restoration" of normal services, the negative impact on trainees particularly benign gynaecology surgical training continues. Addressing pre-pandemic training gaps whilst tackling the surgical back-log and the needs of service provision will continue for years to follow. What is new?: Future training needs to incorporate creative ways of acquiring surgical skills. It is imperative to imbed simulation training into O&G training programmes. Pastoral support is key to ensure trainees' mental and physical well-being are prioritised and the already high burn-out rates do not worsen.

Visualising surgical training in O&G following the COVID-19 pandemic - The European view.

Background & Objectives: Obstetrics and Gynaecology (O&G) training programmes that traditionally relied on the hands-on apprenticeship-training model, became crippled with the global response to the COVID-19 pandemic. Methods: Web-based anonymised survey was circulated to trainee members of the European Society for Gynaecological Endoscopy (ESGE) over 8-weeks period commencing June 2021. Results: 213 trainees from 20 countries responded. Trainees from medium Human Development Index (HDI) countries were less represented. 78% (166/213) were in approved training programmes and 81% (174/213) had access to personal PPE. The vaccine uptake was 87% (185/213). 39% (89/213) and 55% (118/213) experienced negative impact on their physical and mental wellbeing with 36% (76/213) COVID-19 related absence. 15% (32/213) were redeployed to areas outside O&G. 25% (53 /213) had negative impact on their obstetric experience compared to 54% (114/213) reported lower gynaecology surgical exposure and 43% (91/213) failed to meet their gynaecology surgical competencies during the pandemic. 64% (137/213) perceived simulation training as an alternative training tool. Conclusion: In the post-pandemic recovery phase, gynaecological societies and national institutes across Europe continue to develop training curricula implementing virtual and hybrid training modules. The aim is to develop a robust blueprint to safeguard the gynaecological surgical training in the future. What is new?: The ongoing impact on the training in the post pandemic era remains to be evaluated. Our pan Europe survey highlights areas that remain affected from trainees' perspective and assesses differences in the healthcare systems across continent. We then discuss the novel initiatives taken to overcome training gaps.

An unusual histological finding following myomectomy.

Ancient schwannomas are benign tumours arising from the neural sheath of peripheral, cranial and autonomic nerves. They are commonly situated in the inner ear and spine with pelvic manifestations being rare. We present the case of a 30-year-old patient, who presented with an abdominal mass. MRI imaging suggested a broad ligament fibroid and open surgery was undertaken to remove it. Subsequent histology confirmed an ancient schwannoma. This case report details the rarity of such a condition and the need for a high index of suspicion as well as outlining management options and surveillance.

Seven-year retrospective study understanding the latent TB infection treatment cascade of care among adults in a low incidence country.

BACKGROUND: Prevention of TB is paramount to achieving elimination targets as recommended by the World Health Organization's action framework for low incidence countries striving to eliminate TB. Although the rates of TB in Canada are low, understanding the latent TB infection (LTBI) cascade is paramount to identifying gaps in care and treatment barriers, thereby increasing the effectiveness of preventive strategies. The purpose of this study was to examine the LTBI cascade of care and identify barriers to treatment completion in adults referred from primary care to a regional tertiary care TB clinic in Ottawa, Canada. METHODS: Electronic medical records between January 2010 and December 2016 were reviewed retrospectively and an LTBI cascade of care was constructed from The Ottawa Hospital TB clinic and surrounding primary care clinics. A cohort of 2207 patients with untreated LTBI was used to ascertain the associations between demographic and clinical factors for both treatment non-initiation and non-completion using log-binomial univariable and multivariable regression models. RESULTS: Of 2207 patients with untreated LTBI who were seen in the clinic during the study period, 1771 (80.2%) were offered treatment, 1203 (67.9% of those offered) started treatment, and 795 (66.1% of those started) completed treatment. In multivariable analysis, non-initiation of treatment was associated with older age (adjusted risk ratio [aRR] 1.06 per 5-year increase, 95% CI: 1.03-1.08) and female gender (aRR 1.28, 95% CI: 1.11-1.47). Non completion of treatment was associated with referral from the TB Clinic back to the primary care team following initial consult (aRR 1.62, 95% CI: 1.35-1.94) and treatment with the standard of 9 months of Isoniazid (9H) compared to 4 months of Rifampin (4R) (aRR 1.45, 95% CI:1.20-1.74). CONCLUSIONS: LTBI treatment completion was significantly decreased among patients who were referred back to primary care from the TB clinic. The 4R regimen resulted in more people completing LTBI treatment compared to 9H in keeping with a recently published RCT. Improved education, communication, and collaboration between tertiary care TB clinics and primary care teams may improve treatment completion rates and address the TB burden in low incidence communities in Canada.

The impact of COVID-19 on obstetrics and gynaecology trainees; how do we move on?

BACKGROUND: Obstetrics and Gynaecology (O&G) is an evolving specialty that encompasses women's health at its core. The COVID-19 pandemic has caused significant patient care challenges, however simultaneously it has resulted in the interruption of clinical training and cessation of all elective work. Our primary aim was to assess the impact of the pandemic on the experiences of O&G trainees. METHODS: An email invite was sent to all 127 O&G trainees in Kent, Surrey and Sussex (KSS), inviting them to participate in an anonymous 33-question survey. The survey data was collected and analysed over a 4-week period. RESULTS: Of the 127 trainees sent the survey, 87 responded (69%). 39% and 75% of trainees agreed that the pandemic had a negative impact on their overall physical and mental wellbeing respectively. 43% agreed that the COVID-19 pandemic had adversely affected their obstetric training experience whilst almost all trainees stated a significant negative impact on benign gynaecology surgical training. Reassuringly, over 80% were positive they would recover from the negative impacts of COVID-19. CONCLUSIONS: It is evident that COVID-19 has impacted O&G trainees in several ways. Whilst we face uncertain times, we must firstly ensure the physical and mental well-being of all trainees. It is encouraging that non-emergency consultations and benign surgery are being restarted nationwide and whilst this will inevitably help with re-booting surgical training, we must also think "outside" the box and utilise other modes of teaching and training to safeguard learning whilst mitigating against the negative impacts of subsequent waves.

Getting back to business: considerations for restarting non-cancer gynaecological surgery following the COVID-19 peak.

As we begin to pass the first peak of the coronavirus pandemic, the backlog of routine gynaecological surgical work is becoming more apparent and continues to build day by day. The potential for further pandemic surges remain; however it is imperative that elective gynaecological surgery is restored safely, ethically and in a timely manner. The risks of COVID-19 transmission and potential increased surgical morbidity must be weighed up against the patient's ongoing symptoms and quality of life. Universal screening and testing of patients attending for routine surgery, as well as staff testing and retesting, will be fundamental to reducing the risks to both patients and staff, and avoiding the higher morbidity encountered when operating on asymptomatic infected patients. The aim of this paper is to explore pathways to safely reintroduce elective benign gynaecological surgery and the challenges that will be encountered including patient counselling and informed consent, surgical prioritisation and the screening and testing of patients and staff, as well as the logistical and ethical challenges of reintroducing benign surgery during COVID-19 times.

Subcutaneous immunoglobulin in primary immunodeficiency - impact of training and infusion characteristics on patient-reported outcomes.

BACKGROUND: Subcutaneous immunoglobulin (SCIG) is increasingly utilized in primary immunodeficiency (PI). Understanding factors associated with treatment experience and satisfaction can optimize patient outcomes. We analyzed Immune Deficiency Foundation (IDF) survey data to evaluate patient-reported outcomes (PROs) in relation to SCIG training and infusion characteristics. Respondents' PRO scores were rank ordered into 'best', 'intermediate', and 'worst' tertiles. Predicted probabilities of being in the best tertile with any combination of characteristics were generated for each PRO. RESULTS: In 366 SCIG respondents, higher odds of being in the best PRO tertile were driven by favorable training characteristics (particularly, higher confidence post-training and no training barriers) and efficient infusions (infusion preparation ≤20 min and actual infusion < 2 h). Age (≤17 years old) and treatment experience (> 2 years) increased the odds of being in the best tertiles. Compared with the least favorable training/infusion characteristics, those with the most favorable training/infusion characteristics had higher predicted probabilities of being in the best tertiles: TSQM side effects, 59% vs 4%; convenience, 52% vs 4%; effectiveness, 27% vs 13%; global, 26% vs 3%; PROMIS Fatigue, 44% vs 18%. CONCLUSIONS: Increased experience with SCIG consistently improved PROs, but our findings predicted that enhanced training and infusion characteristics improve patient treatment satisfaction beyond that achieved by experience alone.

Caesarean section in women following an abdominal myomectomy: a choice or a need?

Delivery options following both open and laparoscopic myomectomy remains a controversial topic and opinions vary between obstetricians and gynaecologists. The historical advice of planned caesarean section before 39-weeks persists despite the movement towards the minimal access approach for myomectomy. The main concern remains the small, but potentially catastrophic risk of uterine rupture. Unfortunately, there remains a paucity of data assessing factors that can affect the uterine integrity following laparoscopic myomectomy, such as number, size and type of fibroids, uterine cavity breach and electro-cautery usage. Despite this, the cited 1% overall risk of rupture following myomectomy is similar to the quoted risk following trial of labour after caesarean section, and a successful and safe vaginal delivery can be achieved in as high as 90%. Patient choice and informed consent are essential in the holistic approach to managing these women and safely supporting their delivery choices.

Cyclophosphamide-bortezomib-dexamethasone compared with bortezomib-dexamethasone in transplantation-eligible patients with newly diagnosed multiple myeloma.

Introduction: Cyclophosphamide-bortezomib-dexamethasone (CyBorD) is considered a standard induction regimen for transplant-eligible patients with newly diagnosed multiple myeloma (mm). It has not been prospectively compared with bortezomib-dexamethasone (Bor-Dex). We aimed to compare the efficacy of CyBorD and Bor-Dex induction in transplant-eligible patients. Methods: In a retrospective observational study at a single tertiary centre, all patients with transplant-eligible mm who received induction with CyBorD or Bor-Dex between March 2008 and April 2016 were enrolled. Progression-free survival (pfs), response, and stem-cell collection for a first autologous stem-cell transplantation (ahsct) were compared. Results: Of 155 patients enrolled, 78 (50.3%) had received CyBorD, and 77 (49.7%), Bor-Dex. The patients in the Bor-Dex cohort were younger than those in the CyBorD cohort (median: 57 years vs. 62 years; p = 0.0002) and more likely to have had treatment held, reduced, or discontinued (26% vs. 14.5%, p = 0.11). The stem-cell mobilization regimen for both cohorts was predominantly cyclophosphamide and granulocyte colony-stimulating factor (gcsf). Plerixafor was used more often for the CyBorD cohort (p = 0.009), and more collection failures occurred in the CyBorD cohort (p = 0.08). In patients receiving Bor-Dex, more cells were collected (9.9×106 cells/kg vs. 7.7×106cells/kg, p = 0.007). At day +100, a very good partial response or better was achieved in 75% of the CyBorD cohort and in 73% of the Bor-Dex cohort (p = 0.77). Median pfs was 3.2 years in the Bor-Dex cohort and 3.7 years in the CyBorD cohort (p = 0.56). Conclusions: Overall efficacy was similar in our patients receiving CyBorD and Bor-Dex. After ahsct, no difference in depth of response or pfs was observed. Cyclophosphamide-gcsf seems to increase collection failures and hospitalizations in patients receiving CyBorD. Prospective studies are required to examine that relationship.

The implementation of rifapentine and isoniazid (3HP) in two remote Arctic communities with a predominantly Inuit population, the Taima TB 3HP study.

Background: The incidence of TB among Inuit is the highest in Canada. A significantly shorter latent TB infection (LTBI) treatment with rifapentine and isoniazid once weekly for 12 weeks (3HP) is now available in limited settings in Canada.Methods: A prospective open-label 2-year observational postmarketing study was conducted introducing 3HP for the first time in Canada in Iqaluit followed by a program rollout in Qikiqtarjuaq, Nunavut.Results: A total of 247 people were offered 3HP, 102 in the Iqaluit postmarketing study and 145 in the Qikiqtarjuaq program roll out. Although statistical significance was not reached, more people who started treatment completed treatment in the 3HP group (Iqaluit, 60/73 (82.2%) and Qikiqtarjuaq, 89/115 (77.4%)) than in the historical control 9INHgroup (306/420 = 72.9%) (p = 0.2). Most of the adverse events in 3HP treated patients were associated with mild discomfort but no disruption of normal daily activity. Not drinking alcohol was associated with increased 3HP completion (OR 13.33, 95% CI, 2.27-78.20) as was not taking concomitant medications (OR 7.19, 95% CI, 1.47-35.30).Conclusions: The present study supports the feasibility and safety profile of 3HP for the treatment of LTBI in Nunavut.

Covid 19 pandemic and gynaecological laparoscopic surgery: knowns and unknowns.

The worldwide impact of COVID 19 continues to be felt as hospitals in all countries reduce elective and non-urgent cases to allow staffing and resources to be deployed elsewhere. Urgent gynaecological and cancer procedures are continuing, and it is imperative all theatre staff are protected and risks of SARS-CoV-2 viral transmission reduced when operating on asymptomatic, suspected or confirmed COVID 19 patients. In particular, there are concerns relating to the transmission of COVID 19 during gynaecological laparoscopic surgery, arising from the potential generation of SARS-CoV-2 contaminated aerosols from CO2 leakage and the creation of smoke from the use of energy devices. The aim of this paper is to review all the up to date evidence, including experiences from China and Italy, to guide the safe management of such patients when undergoing gynaecological procedures.

A multicentre, randomised trial comparing schedules of G-CSF (filgrastim) administration for primary prophylaxis of chemotherapy-induced febrile neutropenia in early stage breast cancer.

BACKGROUND: The optimal duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer patients is unknown, with 5, 7 or 10 days being commonly prescribed. This trial evaluates whether 5 days of filgrastim was non-inferior to 7/10 days. PATIENTS AND METHODS: In this randomised, open-label trial, early breast cancer patients who were to receive filgrastim as primary FN prophylaxis were randomly allocated to 5 versus 7 versus 10 days of filgrastim for all chemotherapy cycles. A protocol amendment in November 2017 allowed subsequent patients (N = 324) to be randomised to either 5 or 7/10 days. The primary outcome was a composite of either FN or treatment-related hospitalisations. Secondary outcomes included chemotherapy dose reductions, delays and discontinuations. Analyses were carried out by per protocol (primary) and intention-to-treat, and the non-inferiority margin was set at 3% for the risk of having FN and/or hospitalisation per cycle of chemotherapy. RESULTS: Patients (N = 466) were randomised to receive 5 (184, 39.5%), or 7/10 (282, 60.5%) days of filgrastim. In our primary analysis, the difference in risk of either FN or treatment-related hospitalisation per cycle was -1.52% [95% confidence interval (CI): -3.22% to 0.19%] suggesting non-inferiority of a 5-day filgrastim schedule compared with 7/10-days. The difference in events per cycle for FN was 0.11% (95% CI: -1.05 to 1.27) while for treatment-related hospitalisations it was -1.68% (95% CI: -2.73% to -0.63%). The overall proportions of patients having at least one occurrence of either FN or treatment-related hospitalisation were 11.8% and 14.96% for the 5- and 7/10-day groups, respectively (risk difference: -3.17%, 95% CI: -9.51% to 3.18%). CONCLUSION: Five days of filgrastim was non-inferior to 7/10 days. Given the cost and toxicity of this agent, 5 days should be considered standard of care. CLINICALTRIALS. GOV REGISTRATION: NCT02428114 and NCT02816164.

Correction: Evidence-Based Guideline on Laparoscopy in Pregnancy: Commissioned by the British Society for Gynaecological Endoscopy (BSGE) Endorsed by the Royal College of Obstetricians & Gynaecologists (RCOG).

[This corrects the article on p. 5 in vol. 11, PMID: 31695854.].

Patient-reported outcomes with subcutaneous immunoglobulin in chronic inflammatory demyelinating polyneuropathy: the PATH study.

BACKGROUND AND PURPOSE: Chronic inflammatory demyelinating polyneuropathy (CIDP) causes weakness which adversely impacts function and quality of life (QOL). CIDP often requires long-term management with intravenous or subcutaneous immunoglobulin. The Polyneuropathy and Treatment with Hizentra® (PATH) study showed that subcutaneous immunoglobulin (SCIG) was efficacious in CIDP maintenance. Here, patient-reported outcomes in patients on SCIG are assessed. METHODS: Subjects stabilized on intravenous immunoglobulin were randomly allocated to receive weekly 0.2 or 0.4 g/kg bodyweight of 20% SCIG (IgPro20) or placebo. Overall QOL/health status was assessed using the EuroQoL 5-Dimension (EQ-5D) health profile and visual analog scale, treatment satisfaction was assessed with the Treatment Satisfaction Questionnaire for Medicine (TSQM) and work-related impact was assessed with the Work Productivity and Activity Impairment Questionnaire for General Health (WPAI-GH). The EQ-5D health profile was assessed in terms of the percentage of subjects maintained or improved at week 25 of SCIG therapy on each of the EQ-5D domains versus baseline after intravenous immunoglobulin stabilization. TSQM and WPAI-GH were assessed by median score changes from baseline to week 25. RESULTS: In total, 172 subjects were randomized to placebo (n = 57), 0.2 g/kg IgPro20 (n = 57) and 0.4 g/kg IgPro20 (n = 58). Significantly higher proportions of IgPro20-treated subjects improved/maintained their health status on the EQ-5D usual activities dimension, and in additional dimensions (mobility and pain/discomfort) in sensitivity analyses. TSQM and WPAI-GH scores were more stable with IgPro20 treatment compared with placebo. CONCLUSIONS: IgPro20 maintained or improved QOL in most subjects with CIDP, consistent with the PATH study findings that both IgPro20 doses were efficacious in maintaining CIDP.