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Background We piloted a randomised controlled trial (RCT) comparing pregnancy outcomes among women with booking gestational diabetes (GDM) receiving immediate or deferred treatment. Methods Consecutive, consenting women < 20 weeks gestation, with GDM risk factors attending the hospital book-in clinic, completed an oral glucose tolerance test (OGTT). Clinicians were blinded to OGTT results. Women fulfilling World Health Organisation GDM criteria were randomised to either clinic referral /ongoing treatment (Treated Group n  = 11), or no treatment (No Treatment Group n  = 10). Women without ‘Booking GDM’ (‘Decoys’ n  = 58) and those in the No Treatment Group had a repeat OGTT at 24–28 weeks (with GDM treated if diagnosed). Midwives and mothers were asked to complete surveys and attend focus groups before and after the study respectively regarding their experiences and expectations of the study protocol. Results Sufficient women completed each step of the RCT. Gestation at OGTT was late at 18 ± 2 weeks with Treated and No Treatment groups largely similar. At 24–28 weeks gestation, GDM was present in 8/9 (89%) in the No Treatment group and 11/56 (20%) Decoys. NICU admission was highest in the Treated group (36% vs 0% p  = 0.043), largely due to small for gestational age, and Large for Gestational Age babies greatest in the No Treatment group (0% vs 33% p  = 0.030). Conclusion An RCT deferring ‘Booking GDM’ treatment is feasible. Most women with untreated ‘Booking GDM’ in mid 2nd trimester had GDM at 24–28 weeks. Early treatment may have both benefits and harms. A full RCT is needed. Trial registration Australia New Zealand Clinical Trials Registry ACTRN12615000974505. Registered 17th May 2015; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369100&isReview=true Retrospectively Registered.

IntroductionLow back pain (LBP) is commonly treated with opioid analgesics despite evidence that these medicines provide minimal or no benefit for LBP and have an established profile of harms. International guidelines discourage or urge caution with the use of opioids for back pain; however, doctors and patients lack practical strategies to help them implement the guidelines. This trial will evaluate a multifaceted intervention to support general practitioners (GPs) and their patients with LBP implement the recommendations in the latest opioid prescribing guidelines.Methods and analysisThis is a cluster randomised controlled trial that will evaluate the effect of educational outreach visits to GPs promoting opioid stewardship alongside non-pharmacological interventions including heat wrap and patient education about the possible harms and benefits of opioids, on GP prescribing of opioids medicines dispensed. At least 40 general practices will be randomised in a 1:1 ratio to either the intervention or control (no outreach visits; GP provides usual care). A total of 410 patient–participants (205 in each arm) who have been prescribed an opioid for LBP will be enrolled via participating general practices. Follow-up of patient–participants will occur over a 1-year period. The primary outcome will be the cumulative dose of opioid dispensed that was prescribed by study GPs over 1 year from the enrolment visit (in morphine milligram equivalent dose). Secondary outcomes include prescription of opioid medicines, benzodiazepines, gabapentinoids, non-steroidal anti-inflammatory drugs by study GPs or any GP, health services utilisation and patient-reported outcomes such as pain, quality of life and adverse events. Analysis will be by intention to treat, with a health economics analysis also planned.Ethics and disseminationThe trial received ethics approval from The University of Sydney Human Research Ethics Committee (2022/511). The results will be disseminated via publications in journals, media and conference presentations.Trial registration numberACTRN12622001505796.

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder and cause of subfertility in women. The etiology of PCOS has not been fully elucidated; however, insulin resistance has been shown to exacerbate the disease process due to its effect on androgen synthesis. Progressive resistance training (PRT) is an anabolic exercise modality that can improve skeletal muscle size and quality (metabolic capacity), and studies have consistently shown that PRT can increase insulin sensitivity in type 2 diabetes and other cohorts. However, PRT is not currently recommended or routinely prescribed in PCOS. The objective of this article was to provide a rationale for the application of PRT in the management and treatment of PCOS. This will be accomplished by (1) overviewing the pathophysiology of PCOS with emphasis on the etiological role of insulin resistance; (2) summarizing the effectiveness of PRT in treating insulin resistance; (3) presenting evidence that PRT is feasible to prescribe in women with PCOS; and (4) providing general recommendations for PRT to complement existing guidelines for aerobic training in this cohort. We also provide recommendations for future research.

Background To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Methods Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and completion of assessments. Secondary outcomes, collected pre and post intervention, included a range of pertinent physiological, functional and psychological measures. Results Fifteen participants were randomised into the PRT group ( n  = 8) or control group ( n  = 7); five women ( n  = 2 in PRT group and n  = 3 in control group) withdrew from the study. The most successful recruitment sources were Facebook (40 %) and online advertisement (27 %), while least successful methods were referrals by clinicians, colleagues and flyers. In the PRT group, attendance to supervised sessions was higher (95 %; standard deviation ±6 %) compared to unsupervised sessions (51 %; standard deviation ±28 %). No adverse events were attributed to PRT. Change in menstrual cycle status was not significantly different between groups over time ( p  = 0.503). However, the PRT group significantly increased body weight ( p  = 0.01), BMI ( p  = 0.04), lean mass ( p  = 0.01), fat-free mass ( p  = 0.005) and lower body strength ( p  = 0.03), while reducing waist circumference ( p  = 0.03) and HbA 1c ( p  = 0.033) versus the control group. The PRT group also significantly improved across several domains of disease-specific and general health-related quality of life, depression, anxiety and exercise self-efficacy. Conclusion A randomized controlled trial of PRT in PCOS would be feasible, and this mode of exercise may elicit a therapeutic effect on clinically important outcomes in this cohort. The success of a large-scale trial required to confirm these findings would be contingent on addressing the feasibility hurdles identified in this study with respect to recruitment, attrition, compliance, and collection of standardized clinical data. Trial registration Australia New Zealand Clinical Trials Registry; ACTRN12614000517673 Registered 15 May 2014.

Background Previous research has reported that Australians with limited English proficiency are less likely to be included in clinical trials due to language, literacy, and cultural factors. In the pain field, participants with limited English proficiency are three times more likely to be excluded from research, whereas in low back pain trials, 1 in 5 participants are excluded. This low representation can limit the generalisability of research findings to Australia’s diverse population, and strategies are required to facilitate the inclusion of participants with limited English proficiency in clinical trials. This study within a trial (SWAT) embedded within a registered cluster randomised trial (ACTRN12622001505796) will evaluate a strategy to improve recruitment of participants with limited English proficiency who speak Arabic, Cantonese, Mandarin or Italian. These were chosen as they are the top non-English languages spoken at home in Australia. Methods This SWAT will evaluate the effect of per-participant monetary incentive to facilitate the recruitment of participants with limited English proficiency (in Arabic, Chinese and Italian communities) from participating general practices enrolled in the COMFORT trial. In brief, the COMFORT trial will randomise general practices in a 1:1 ratio to either (i) intervention (educational outreach visits to support GPs to provide opioid stewardship for their patients with low back pain with non-drug strategies including heat wraps and patient education about judicious opioid use) or (ii) control (usual care). In this embedded SWAT, the randomisation schedule will also randomly allocate general practices 1:1 to either (a) SWAT intervention (monetary incentive aimed at enhancing recruitment of individuals with limited English proficiency) or (b) SWAT control (no additional incentive). The SWAT primary outcome will be the proportion of participants with limited English proficiency enrolled into the COMFORT trial in the SWAT intervention versus SWAT control. Data collection, analyses and general study procedures will follow the COMFORT protocol. Discussion This SWAT will determine whether a per-participant monetary incentive facilitates greater recruitment of people with limited English proficiency who speak Arabic, Cantonese, Mandarin or Italian by participating GPs. Trial registration The trial has been registered via SWAT222 Christina Abdel Shaheed (2023 NOV 14 1147).pdf.

Human papillomaviruses (HPVs) are associated with invasive malignancies, including almost 100% of cervical cancers (CECs), and 35–70% of oropharyngeal cancers (OPCs). HPV infection leads to clinical implications in related tumors by determining better prognosis and predicting treatment response, especially in OPC. Currently, specific and minimally invasive tests allow for detecting HPV-related cancer at an early phase, informing more appropriately therapeutical decisions, and allowing for timely disease monitoring. A blood-based biomarker detectable in liquid biopsy represents an ideal candidate, and the use of circulating HPV DNA (ct-DNA) itself could offer the highest specificity for such a scope. Circulating HPV DNA is detectable in the greatest part of patients affected by HPV-related cancers, and studies have demonstrated its potential usefulness for CEC and OPC clinical management. Unfortunately, when using conventional polymerase chain reaction (PCR), the detection rate of serum HPV DNA is low. Innovative techniques such as droplet-based digital PCR and next generation sequencing are becoming increasingly available for the purpose of boosting HPV ct-DNA detection rate. We herein review and critically discuss the most recent and representative literature, concerning the role of HPV ctDNA in OPC and CEC in the light of new technologies that could improve the potential of this biomarker in fulfilling many of the unmet needs in the clinical management of OPC and CEC patients.

The actual role of chemotherapy in vulvar cancer is undeniably a niche topic. The low incidence of the disease limits the feasibility of randomized trials. Decision making is thus oriented by clinical and pathological features, whose relevance is generally weighted against evidence from observational studies and clinical practice. The therapeutic management of vulvar cancer is increasingly codified and refined at an individual patient level. It is of note that the attitude towards evidence sharing and discussion within a multidisciplinary frame is progressively consolidating. Viable options included in the therapeutic armamentarium available for vulvar cancer patients are frequently an adaption from standards used for cervical or anal carcinoma. Chemotherapy is more frequently combined with radiotherapy as neo-/adjuvant or definitive treatment. Drugs commonly used are platinum derivative, 5-fluorouracil and mitomicin C, mostly in combination with radiotherapy for radiosensitization. Exclusive chemotherapy in the neo-/adjuvant setting comprises platinum-derivative, combined with bleomicin and methotrexate, 5-fluorouracil, ifosfamide or taxanes. In advanced disease, current regimens include cisplatin-based chemoradiation, with or without 5-fluorouracil, or doublets with platinum in combination with a taxane. Our work is also enriched by a concise excursus on the biologic pathways underlying vulvar cancer. Introductory hints are also provided on targeted agents, a rapidly evolving research field.