BACKGROUND: Selective fetal growth restriction (sFGR) in monochorionic twin pregnancy, defined as an estimated fetal weight (EFW) of one twin <10th centile and EFW discordance ≥25%, is associated with stillbirth and neurodisability for both twins. The condition poses unique management difficulties: on the one hand, continuation of the pregnancy carries a risk of death of the smaller twin, with a high risk of co-twin demise (40%) or co-twin neurological sequelae (30%). On the other, early delivery to prevent the death of the smaller twin may expose the larger twin to prematurity, with the associated risks of long-term physical, emotional and financial costs from neurodisability, such as cerebral palsy.When there is severe and early sFGR, before viability, delivery is not an option. In this scenario, there are currently three main management options: (1) expectant management, (2) selective termination of the smaller twin and (3) placental laser photocoagulation of interconnecting vessels. These management options have never been investigated in a randomised controlled trial (RCT). The best management option is unknown, and there are many challenges for a potential RCT. These include the rarity of the condition resulting in a small number of eligible pregnancies, uncertainty about whether pregnant women will agree to participate in such a trial and whether they will agree to be randomised to expectant management or active fetal intervention, and the challenges of robust and long-term outcome measures. Therefore, the main objective of the FERN study is to assess the feasibility of conducting an RCT of active intervention vs expectant management in monochorionic twin pregnancies with early-onset (prior to 24 weeks) sFGR.
METHODS: The FERN study is a prospective mixed-methods feasibility study. The primary objective is to recommend whether an RCT of intervention vs expectant management of sFGR in monochorionic twin pregnancy is feasible by exploring women\'s preference, clinician\'s preference, current practice and equipoise and numbers of cases. To achieve this, we propose three distinct work packages (WPs). WP1: A Prospective UK Multicentre Study, WP2A: a Qualitative Study Exploring Parents\' and Clinicians\' Views and WP3: a Consensus Development to Determine Feasibility of a Trial. Eligible pregnancies will be recruited to WP1 and WP2, which will run concurrently. The results of these two WPs will be used in WP3 to develop consensus on a future definitive study. The duration of the study will be 53 months, composed of 10 months of setup, 39 months of recruitment, 42 months of data collection, and 5 months of data analysis, report writing and recommendations. The pragmatic sample size for WP1 is 100 monochorionic twin pregnancies with sFGR. For WP2, interviews will be conducted until data saturation and sample variance are achieved, that is, when no new major themes are being discovered. Based on previous similar pilot studies, this is anticipated to be approximately 15-25 interviews in both the parent and clinician groups. Engagement of at least 50 UK clinicians is planned for WP3.
BACKGROUND: This study has received ethical approval from the Health Research Authority (HRA) South West-Cornwall and Plymouth Ethics Committee (REC reference 20/SW/0156, IRAS ID 286337). All participating sites will undergo site-specific approvals for assessment of capacity and capability by the HRA. The results of this study will be published in peer-reviewed journals and presented at national and international conferences. The results from the FERN project will be used to inform future studies.
BACKGROUND: This study is included in the ISRCTN Registry (ISRCTN16879394) and the NIHR Central Portfolio Management System (CPMS), CRN: Reproductive Health and Childbirth Specialty (UKCRN reference 47201).

OBJECTIVE: To report the natural history of vestibular schwannoma (VS) who elected an initial period of observation and identify prognostic factors. To describe the natural history of growing VS, identify prognostic factors, and review the most recent literature.
METHODS: Prospective cohort study and literature review.
METHODS: Tertiary referral center.
METHODS: Adult patients diagnosed with a VS between January 1998 and February 2023.
METHODS: Magnetic resonance imaging surveillance.
METHODS: Growth-free survival and subsequent growth-free survival considering significant growth as a change in size of ≥2 mm.
RESULTS: Of 430 patients undergoing observation with serial magnetic resonance imaging, 193 (44.9%) demonstrated significant growth at a median of 1.6 years (interquartile range, 0.94-3.51). Of the 193 patients who presented an initial episode of growth, 137 elected to continue to be observed. Of those, 83 (60.6%) presented a second episode of growth at a median of 1.43 years (interquartile range, 1.00-2.49). The subsequent growth-free survival rates (95% confidence interval) at 1, 3, 5, 7, and 10 years were 91.79% (87.26-96.56%), 64.44% (56.56-73.42%), 52.52% (44.23-62.35%), 42.23% (33.92-52.56%), and 36.11% (27.89-46.76%), respectively. Univariate and multivariate Cox regression analyses showed that EC tumor location and initial growth rate were significant predictors of subsequent growth.
CONCLUSIONS: Close observation after documentation of growth is an appropriate management in well-selected cases given that only around 56% of the tumor will continue to grow. Extracanalicular tumor location and initial growth rate are promising prognostic factors to help determine which patient would be a better candidate for close surveillance after initial documentation of growth.

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OBJECTIVE: As part of the FERN feasibility study, this qualitative research aimed to explore parents\' and clinicians\' views on the acceptability, feasibility and design of a randomised controlled trial (RCT) of active intervention versus expectant management in monochorionic (MC) diamniotic twin pregnancies with early-onset (prior to 24 weeks) selective fetal growth restriction (sFGR). Interventions could include laser treatment or selective termination which could lead to the death or serious disability of one or both twins.
METHODS: Qualitative semi-structured interviews with parents and clinicians. Data were analysed using reflexive thematic analysis and considered against the Principles of Biomedical Ethics.
METHODS: We interviewed 19 UK parents experiencing (six mothers, two partners) or had recently experienced (eight mothers, three partners) early-onset sFGR in MC twin pregnancy and 14 specialist clinicians from the UK and Europe.
RESULTS: Participants viewed the proposed RCT as \'ethically murky\' because they believed that the management of sFGR in MC twin pregnancy should be individualised according to the type and severity of sFGR. Clinicians prioritised the gestational age, size, decrease in growth velocity, access to the placental vessels and acceptability of intervention for parents. Discussions and decision-making about selective termination appeared to cause long-term harm (maleficence). The most important outcome for parents and clinicians was \'live birth\'. For clinicians, this was the live birth of at least one twin. For parents, this meant the live birth of both twins, even if this meant that their babies had neurodevelopmental impairment or disabilities.
CONCLUSIONS: All three pregnancy management approaches for sFGR in MC twin pregnancy carry risks and benefits, and the ultimate goal for parents is to receive individualised care to achieve the best possible outcome for both twins. An RCT was not acceptable to parents or clinicians or seen as ethically appropriate. Alternative study designs should be considered to answer this important research question.

BACKGROUND: Many types of prostate cancer present minimal risk to a man\'s lifespan or well-being, but existing terminology makes it difficult for men to distinguish these from high-risk prostate cancers. This study aims to explore whether using an alternative label for low-risk prostate cancer influences management choice and anxiety levels among Australian men and their partners.
METHODS: We will run two separate studies for Australian men and Australian women with a male partner. Both studies are between-subjects factorial (3×2) randomised online hypothetical experiments. Following consent, eligible participants will be randomised 1:1:1 to three labels: \'low-risk prostate cancer, Gleason Group 1\', \'low-risk prostate neoplasm\' or \'low-risk prostate lesion\'. Participants will then undergo a second randomisation step with 1:1 allocation to the provision of detailed information on the benefits and harms of different management choices versus the provision of less detailed information about management choices. The required sample sizes are 1290 men and 1410 women. The primary outcome is the participant choice of their preferred management strategy: no immediate treatment (prostate-specific antigen (PSA)-based monitoring or active surveillance using PSA, MRI, biopsy with delayed treatment for disease progression) versus immediate treatment (prostatectomy or radiation therapy). Secondary outcomes include preferred management choice (from the four options listed above), diagnosis anxiety, management choice anxiety and management choice at a later time point (for participants who initially choose a monitoring strategy).
BACKGROUND: Ethics approval has been received from The University of Sydney Human Research Ethics Committee (2023/572). The results of the study will be published in a peer-reviewed medical journal and a plain language summary of the findings will be shared on the Wiser Healthcare publications page http://www.wiserhealthcare.org.au/category/publications/ TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ID 386701 and 386889).

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BACKGROUND: \"Watch-and-wait\" approach is an important management option in asymptomatic follicular lymphoma (FL) patients with low tumor burden. Since most FL lesions are FDG-avid, we wonder if 18F-FDG PET/CT at baseline can help to better choose the patients who can benefit from early chemotherapy. This study aimed to investigate the prognostic value of baseline 18F-FDG PET/CT in newly diagnosed FL patients treated with either watch-and-wait approach or chemotherapy.
RESULTS: Patients received chemotherapy as initial treatment had higher Ann Arbor stage, higher incidence of extranodal involvement and bulky disease, more involved lymph nodes larger than 3 cm, and higher SUVmax, MTV, and TLG than those managed with watch-and-wait approach (p < 0.05). The median PFS and TTNT in patients received chemotherapy and under watch-and-wait did not show significant difference, however patients with MTV<111.66 mL or TLG<141.50 SUVbw*mL had significantly longer PFS and TTNT than those patients with MTV≥111.66 mL or TLG≥141.50 SUVbw*mL (p < 0.05). Further analysis revealed that for patients with TLG≥141.50 SUVbw*mL or MTV≥111.66 mL, those who received chemotherapy as initial treatment had a significantly longer PFS and TTNT than those managed with initial watch-and-wait approach (p < 0.05). However, for patients with MTV<111.66 mL or TLG<141.50 SUVbw*mL in baseline PET/CT, there was no significant difference in PFS or TTNT between patients who received chemotherapy and those under watch-and-wait.
CONCLUSIONS: Baseline 18F-FDG PET/CT may provide prognostic value and help to improve the decision-making of initial treatment plans for newly diagnosed FL patients.

BACKGROUND: Individual studies on men with mildly symptomatic or asymptomatic inguinal hernia who have opted for watchful waiting (WW) vary considerably. Furthermore, long-term data on such patients who cross over to herniorrhaphy is scarce.
METHODS: PubMed, EMBASE, and Cochrane databases were searched systematically from inception to 3rd April 2024 for long-term follow-up of randomized controlled trials (RCTs) on men with mildly symptomatic or asymptomatic inguinal hernia. Individual participant survival data of cross over rates from WW to herniorrhaphy were extracted, reconstructed and combined. Secondary outcome was reason for cross over to herniorrhaphy.
RESULTS: Long-term follow-up of three RCTs with 592 participants was included. A total of 344/592 participants crossed over to herniorrhaphy during a median follow up period that ranged from 3.2 to 12.0 years. The median cumulative cross over rate was 54.2% (95% CI 45.5% - 66.3%). The cumulative 1-year, 5-year, and 10- year cross over rates were 28.7% (95% CI 25.2% - 32.5%), 51.5% (95% CI 47.4% - 55.6%), and 70.6% (95% CI 66.2% - 74.9%) respectively. During follow-up, the most frequent reasons for cross over to herniorrhaphy were increased pain 198/344 (57.6%) and incarceration 15/344 (4.4%).
CONCLUSIONS: This study provides valuable long-term data for patient counselling, indicating that while WW is a safe strategy for men with mildly symptomatic or asymptomatic inguinal hernia, symptoms would likely progress eventually, necessitating operative repair.

OBJECTIVE: The aim of this study was to evaluate and compare the fear of cancer recurrence (FCR) in patients diagnosed with a small renal mass (SRM) and managed with either active surveillance (AS) or minimal invasive renal cryoablation (CA).
METHODS: A total of 398 patients with SRMs (263 AS and 135 CA patients) were retrospectively identified across three institutions and invited to complete the Fear of Cancer Recurrence-Short Form (FCRI-SF) questionnaire.
RESULTS: No statistically significant differences in FCRI-SF score were observed between the AS (mean = 10.9, standard deviation [SD] = 6.9) and CA (mean = 10.2, SD = 7.2) (p = 0.559) patients, with the mean scores of both groups being below the suggested clinically significant cut-off of 16. A total of 25% of AS and 28% of CA patients reported sub-clinical or clinical levels of FCR (FCRI-SF score > 16). Within the AS group, a weak negative association between FCR severity and age was observed (r = -0.23, p = 0.006), and a statistically significant difference in FCRI-SF score between patients aged more or less than 73 years (p = 0.009).
CONCLUSIONS: FCR levels were comparable between AS and CA patients, suggesting that treatment decisions should prioritise clinical factors. Up to 28% of AS and CA patients report clinically significant FCR, highlighting the importance of considering the possibility of FCR, especially in younger patients.

The recent surge in the incidence of small papillary thyroid cancers (PTCs) has been linked to the widespread use of ultrasonography, thereby prompting concerns regarding overdiagnosis. Active surveillance (AS) has emerged as a less invasive alternative management strategy for low-risk PTCs, especially for PTCs measuring ≤1 cm in maximal diameter. Recent studies report low disease progression rates of low-risk PTCs ≤1 cm under AS. Ongoing research is currently exploring the feasibility of AS for larger PTCs (<20 mm). AS protocols include meticulous ultrasound assessment, emphasis on standardized techniques, and a multidisciplinary approach; they involve monitoring the nodules for size, growth, potential extrathyroidal extension, proximity to the trachea and recurrent laryngeal nerve, and potential cervical nodal metastases. The criteria for progression, often defined as an increase in the maximum diameter of the PTC, warrant a review of precision and ongoing examinations. Challenges exist regarding the reliability of volume measurements for defining PTC disease progression. Although ultrasonography plays a pivotal role, challenges in assessing progression and minor extrathyroidal extension underscore the importance of a multidisciplinary approach in disease management. This comprehensive overview highlights the evolving landscape of AS for PTCs, emphasizing the need for standardized protocols, meticulous assessments, and ongoing research to inform decision-making.