Questo è quello che abbiamo trovato per te
This randomized noninferiority trial assesses the effect of a strategy of active monitoring vs guideline-concordant care on 2-year risk of ipsilateral invasive breast cancer among women with low-risk breast ductal carcinoma in situ.
Ductal carcinoma in situ (DCIS) is considered a nonobligate precursor of invasive breast cancer. Surgery is thought to reduce this risk, as evidenced by studies demonstrating cause-specific survival of 97% to 98% after treatment with mastectomy or lumpectomy with or without radiotherapy. Invasive cancer is found at surgical excision in 26% of all women diagnosed with DCIS by core biopsy and in 20% of those with low- to intermediate-grade DCIS or lesions of 2 cm or smaller on mammography. Despite the apparent success of surgery, significant concerns about overtreatment of DCIS have been raised. The substantial increase in the detection of DCIS between 1992 and 2011 that coincided with the widespread adoption of screening mammography did not result in parallel reductions in invasive cancer detection or breast cancer mortality, suggesting that a proportion of the DCIS being identified would have never progressed to invasive cancer. The very high cause-specific survival after surgery and the limited knowledge of the evolution of untreated DCIS raises the possibility that similar excellent outcomes might be obtained with a less aggressive approach such as active monitoring, with surgery reserved for patients showing evidence of progression to invasive cancer; however, the safety of this approach is uncertain. Ideally, a subset of DCIS patients at low risk of progression to invasive cancer could be identified by molecular profiling, but at present, this goal remains aspirational.
Background
Sexual and reproductive health (SRH) programmes and services aim to prevent complications of pregnancy and childbirth, unintended pregnancies, unsafe abortions, complications caused by sexually transmitted infections, including HIV, sexual violence and impacts from avoidable cancer.
Objective
To systematically identify published economic evaluations of SRH programmes and services, assess the methods used and analyse how costs and outcomes are estimated in these studies.
Settings
Low- and middle-income countries.
Design
Systematic review and narrative synthesis.
Methods
Eight databases were searched, including EMBASE, MEDLINE, Scopus, Health Technology Assessment, Web of Science, PsycINFO, National Health Service Economic Evaluation Database (NHS EED) and African Journals Online (AJOL) from 1998 to December 2023. The inclusion and exclusion criteria were developed using the Population, Intervention, Comparator, Outcome and Study Design framework. The review included economic evaluations alongside randomised trials and economic studies with modelling components. Study characteristics, methods and results of economic evaluations were extracted and tabulated. The quality of the studies was assessed using the Consensus Health Economic Criteria list and Philips checklists for trial-based and model-based studies, respectively. The review followed the reporting guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and the results were synthesised narratively in line with Centre for Reviews and Dissemination guidance.
Results
7575 studies were screened and categorised. 20 studies were included in the review. The studies assessed the cost-effectiveness and costs of SRH programmes and services from an individual, healthcare or societal perspective. The main SRH programme considered was contraceptive services. The main outcome measures reported were disability-adjusted life years, quality-adjusted life years, couple years of protection and pregnancies averted. Most of the studies did not indicate the costing approach used, and many of the studies evaluated direct medical costs only. Most of the study designs were model-based with significant heterogeneity between the models. The review showed that many studies did not fulfil all of the requirements for a high-quality economic evaluation. 1 out of the 20 studies reviewed considered equity.
Conclusions
The review revealed heterogeneity in approaches to evaluating the costs and outcomes of SRH programmes. These methodological limitations may have implications for their use by public health decision-makers to inform optimal decision-making.
PROSPERO registration number
CRD42023435241.
Circulation, Volume 151, Issue 11, Page e762-e762, March 18, 2025.
Background
Nearly half of individuals who sustain orthopaedic trauma develop chronic pain and experience significant levels of depression and anxiety. Emotional awareness and expression therapy (EAET) is a newly developed psychological intervention designed to treat chronic pain by helping patients process psychological trauma and conflict to reduce pain. The purpose of this study is to examine the feasibility of delivering EAET to individuals who sustained traumatic orthopaedic injuries requiring surgery and who have chronic pain 6 months after hospital discharge.
Methods and analysis
The study will consist of a single-arm design. Thirty individuals who sustained traumatic orthopaedic injuries requiring surgery and who reported chronic pain 6 months after hospital discharge will be recruited. Participants will receive eight sessions of individually administered EAET delivered via telehealth and complete self-report questionnaires at three timepoints (pretreatment, post-treatment and 3-month follow-up). Quantitative sensory testing will also be done before and after treatment. The primary outcome of the study is feasibility (eg, per cent of eligible patients recruited and per cent of study completers) and acceptability as reported by responses to a self-report questionnaire.
Ethics and dissemination
This study has been approved by the Johns Hopkins Institutional Review Board. All data are expected to be collected by 2026, with results of this study to be disseminated via relevant peer-reviewed journals and scientific conferences.
Trial registration number
ClinicalTrials.gov NCT05989230. Registered on 14 August 2023.
In a meta-analysis, clinically significant depression and anxiety each were found in 40% of patients.
Background
Objective: This study aimed to use the Robson Ten Group Classification System (TGCS) to assess caesarean section (CS) rates and other outcomes in eight referral hospitals in Burkina Faso before the implementation of non-clinical interventions to reduce unnecessary CSs.
Design
This is a cross-sectional study.
Setting
We conducted a 9-month prospective observational study on women who gave birth at eight referral hospitals in Burkina Faso between 1 April 2020 and 31 December 2020.
Participants
We analysed 24 643 women who gave birth at the eight participating hospitals during the study period.
Outcomes measures
We reported the relative size, CS rate and absolute contribution of each Robson group. These indicators were calculated for both referred and non-referred women. Oxytocin administration and stillbirth rates were calculated for women without previous CS and with a single fetus at cephalic presentation at term (groups 1–4).
Results
Overall, 24 643 women gave birth at the eight participating hospitals during the 9- month study period. The overall CS rate was 30.6%. Women in spontaneous labour with a single fetus in the cephalic presentation at term without previous CS (groups 1 and 3) had high CS rates (26.5% and 15%, respectively), low oxytocin use (7.9% and 6.5%, respectively), and high stillbirth rates (3.4% and 3.9%, respectively). These subgroups of women were major contributors to the overall CS rate.
Conclusion
Our results indicate that, in referral hospitals in Burkina Faso, the CS practice for referred women in groups 1 and 3 of the TGCS should receive special attention. These results also reveal areas for clinical improvement to reduce primary CS, especially in nulliparous women. The use of the TGCS is important in low-income countries where low CS rates at the population level may conceal suboptimal labour management in healthcare facilities.
Trial registeration number
ISRCTN67214403.
Purpose
The Norwegian Neck and Back Registry (Norsk Nakke og Rygg Register, NNRR) was established to improve the quality of diagnosis and treatment in patients with neck and back complaints at Departments of Physical Medicine and Rehabilitation (PMR) in Norwegian hospitals. The purpose of this cohort profile is to describe the data from registered patients from 2016 to 2022 and linkage opportunities.
Participants
The registry includes adult patients with neck and back complaints referred to PMR multidisciplinary neck and back outpatient clinics in Norwegian hospitals. As of 2022, more than 8000 men and more than 10 000 women are included in the registry. Patients are predominantly diagnosed with non-specific neck or back conditions. The registry includes baseline and follow-up questionnaires from patients and their clinicians, collecting a broad range of self-reported data including demographic characteristics, employment, benefits, symptoms, diagnosis, treatment and treatment history, as well as quality of life. Participation is voluntary, and all patients in the registry have consented for the collected data to be linked with other national registries, presenting opportunities for large-scale registry-based scientific studies. Recruitment of patients to the registry is ongoing, and since 2016, an increasing number of patients have been included per year, with over 5000 in 2021 and 2022.
Findings to date
Data from the NNRR have been used to improve our understanding of what characterises neck and back patients in specialist healthcare compared with patients in primary healthcare, how neck and back symptoms differ according to ethnicity and language, how nationality influences outcome trajectories for neck and back patients, and for studying properties of measurement instruments.
Future plans
Future plans involve expanding the registry to include patients from the remaining three neck and back outpatient clinics in order to obtain a complete national register in Norway, and to facilitate increased use of the data for quality improvement and research purposes. The registry welcomes collaboration with other researchers.
Annals of Internal Medicine, Ahead of Print.
This blinded trial of autologous PRP showed no benefit for pain or function.
Pediatric irritable bowel syndrome (IBS) and functional abdominal pain – not otherwise specified (FAP-NOS) lack effective pharmacologic interventions. We evaluated the efficacy of mebeverine, an antispasmodic agent, and the effect of labeling within a pediatric cohort.
Introduction
It is common for finger pain in hand osteoarthritis (HOA) to display a neuropathic component. Non-steroidal anti-inflammatory drugs (NSAIDs) and conventional analgesics are not very effective in relieving this neuropathic-like pain. Capsaicin, a compound extracted from chilli peppers, is approved for the management of localised neuropathic pain. However, the effectiveness of an 8% capsaicin transdermal patch has never been tested in HOA patients with neuropathic-like pain in a randomised setting. In this study, we aimed to compare the 60-day (D60) efficacy of a transdermal application of capsaicin 8% versus a control (very low-dose capsaicin at 0.04%) on hand pain in patients with painful digital osteoarthritis with a neuropathic-like pain component.
Methods and analysis
CADOR (CApsaicin in neuropathic-like pain in Digital Osteoarthritis: a Randomised trial) is a multicentre, randomised, controlled, double-blind, two parallel group, phase 3 clinical trial. Eligible patients have HOA according to the American College of Rheumatology criteria and at least Kellgren-Lawrence grade≥2, with neuropathic-like pain (‘Douleur neuropathique en 4 questions’ (DN4) score≥4/10 and pain intensity≥40/100 mm). At Day 0, 120 patients will be randomised (1:1) to receive a single 30 min topical application of either capsaicin 8% transdermal patch (experimental group) or capsaicin 0.04% transdermal patch (control group). The primary outcome is pain intensity in the fingers over the past 48 hours at Day 60, measured with a Visual Analogue Scale (VAS) ranging from 0 to 100 mm. Secondary outcomes are functional disability, quality of life, anxiety and depression, the patient’s global impression of improvement, use of analgesics and NSAIDs and the safety of capsaicin. At visit D60, patients who still have finger pain≥40/100 mm on the VAS will receive, if they wish a single 30 min topical application of capsaicin 8% transdermal patch (not blinded). The efficacy of two transdermal applications of capsaicin (either two applications of 8% patch in the experimental arm or one application of 0.04% and one application of 8% in the control arm) will be assessed on Day 120.
Ethics and dissemination
Ethics approval was obtained from the French Health Authorities (Comité de protection des Personnes SUD EST V and Agence Nationale de Sécurité du Médicament) on 23 May 2024 in accordance with European Regulation n°536/2014 of 16 April 2014 (ref: 2024-511159-16-00) before participant enrolment.
Trial registration number
ClinicalTrials.gov: NCT06444919.
Clinical presentation A 34-year-old man presented to our institution for review with recurrent abdominal pain, constipation, lethargy, fevers and episodic migratory soft tissue severe cellulitis of the limbs after minimal exercise. This was on a background of a diagnosis of eosinophilic enterocolitis at the age of 10 when due to recurrent abdominal pain, endoscopy was performed with biopsies showing eosinophilic infiltration of the oesophagus, stomach, duodenum and colon. This had been treated with steroids in the past with clinical response. A variety of disease-modifying antirheumatic drugs (DMARDs) failed to provide a steroid-sparing effect previously. Clinical history was otherwise significant for resolved childhood asthma and eczema. The patient underwent a gastroscopy and colonoscopy which demonstrated oesophageal (figure 1A), stomach, duodenal and terminal ileal eosinophilic infiltration, along with pancolitis on colonic biopsies. After initial endoscopic evaluation, the patient had a recurrence of abdominal pain and migratory right lower…
Introduction
Endometriosis affects 10–15% of people assigned female at birth and can cause chronic pelvic pain and impair many domains of quality of life, such as fertility, mood and bladder, bowel and sexual function. Current treatments often fail, leading to recurrent pain and the need for reintervention. As endometriosis negatively affects many domains of life, a variety of non-pharmacological treatments modestly improve symptoms. To bundle these interventions into accessible packaging, our interdisciplinary team developed a novel endometriosis intervention titled ‘Peer-Empowered Endometriosis Pain Support (PEEPS)’, an 8-week integrative group care intervention. Here, we present the protocol for a pilot randomised controlled trial (RCT) to evaluate the effectiveness and implementation of PEEPS for people with endometriosis-associated pain refractory to surgical management. We hypothesise that patients who complete the PEEPS programme will show a greater decrease in pain interference in daily activities at intervention completion as compared with baseline than those in the education arm.
Methods and analysis
This is a hybrid type 1 effectiveness-implementation mixed-methods RCT in which 60 participants will be randomised using computer-generated random numbers stratified by group in the ratio 1:1 to PEEPS plus usual versus educational handout plus usual care. The primary outcome is change in pain interference from baseline to intervention completion. Secondary outcomes include change in pain interference from baseline to 6 months and 12 months postintervention, as well as change in other quality-of-life measures as measured by nine validated questionnaires from baseline to completion, 6 months and 12 months. Proctor et al’s Implementation Outcomes Framework will be used to evaluate acceptability, appropriateness and feasibility of PEEPS implementation, and the Consolidated Framework for Implementation Research will be used to guide the evaluation of barriers and facilitators of PEEPS at the patient and provider levels. Primary data analyses will follow the intention-to-treat principle. Descriptive statistics and two-sample t-tests for normally distributed values and Wilcoxon Rank-Sum test were performed for non-normally distributed values. Frequency analysis and Fisher’s exact or 2 tests will be used for categoric variables as appropriate. Longitudinal analysis of the primary and secondary outcomes will be conducted with a mixed-effects model to investigate the effect of PEEPS compared with education. Least square means (LSMs) and the corresponding 95% CIs at each timepoint, as well as LSM differences and 95% CIs between any post-baseline and baseline will be provided for the outcomes. ORs and 95% CIs will be calculated for categorical outcomes. Qualitative data will be collected in the form of open-ended feedback, focus groups with programme completers and semistructured interviews with participants who complete two or fewer sessions. The analysis will use an embedded design-experimental model in which quantitative and qualitative outcomes will occur concurrently with weight priority given to quantitative data.
Ethics and dissemination
This trial was approved by the Washington University in St. Louis Institutional Review Board (protocol 202402082) on 27 March 2024 and has low risk of harm to participants. All deidentified data from this project will be shared via Digital Commons@Becker. The findings of this study will be disseminated via scientific meetings and peer-reviewed journals. The results and conclusions will be summarised for patients and the public in common language using infographics to make the findings accessible. This pilot RCT will yield the effect size for PEEPS and generate implementation context and outcomes data to guide PEEPS application to real-world practice. If PEEPS proves to be effective, this study will inform adaptation and scaling to improve the lives of people with endometriosis through a non-hormonal, fertility-preserving approach.
Trial registration number
ClinicalTrials.gov; NCT06549985.
Introduction
Patients with knee osteoarthritis are at a higher risk of falls compared to healthy individuals, thereby increasing the likelihood of accidental injury. Resistance training is an important strategy for managing knee osteoarthritis. Although some studies suggest that blood flow restriction training combined with low-load resistance training (LL-BFRT) is a beneficial treatment approach, its effect on fall risk and balance function in patients with knee osteoarthritis remains unclear. We aim to conduct a randomised controlled trial to assess the effectiveness of combined training in reducing fall risk and improving function in patients with knee osteoarthritis.
Methods and analysis
We will conduct a single-blind pilot randomised controlled trial involving patients with knee osteoarthritis. 98 patients will be randomly assigned to either the LL-BFRT group or the low-load resistance training (LL-RT) group, with a 1:1 allocation ratio. Both groups will undergo a 4-week intervention. Follow-up assessments will be conducted at baseline, 4 weeks, 16 weeks, 28 weeks and 52 weeks. The primary outcome will be the measurement of the fall risk stability index and overall stability index using the Biodex Balance System. Secondary outcomes include the Numerical Rating Scale, the Western Ontario and McMaster Universities Osteoarthritis Index, the 30 s Chair Stand Test, proprioception testing, the Timed Up and Go Test, the Short Form-36 scores, compliance and adverse events. Intention-to-treat principles will be applied in data analysis.
Ethics and dissemination
This study has been approved by the Ethics Review Committee of the First Hospital of Quanzhou Affiliated Fujian Medical University (2024-K161). The results of the study will be disseminated through peer-reviewed publications.
Trial registration number
ChiCTR2400087829.
Our findings suggest that IPV is more prevalent in urban slums than other areas, underscoring the need for targeted public health strategies, such as addressing harmful partner’s behaviors.
