Search Results for: Low Back Pain: raccomandazioni

Objectives
The double blind, multicentre, randomised, placebo-controlled GAG-therapy Efficacy Trial Solution for Bladder pain syndrome/Interstitial cystitis (GETSBI) study aims to evaluate the efficacy of intravesical glycosaminoglycans therapy with hyaluronic acid and chondroitin sulfate in symptomatic bladder pain syndrome/interstitial cystitis (BPS/IC) patients with Hunner lesions. This trial encompasses multiple methodologies, including a standard randomised controlled trial (RCT), a cross-over trial and an N-of-1 trial. An N-of-1 trial is a multiple crossover trial, usually randomised and often blinded, conducted in a single patient (1). The N-of-1 methodology is, however, only valid under the condition that there is no carry-over effect, meaning a carry-over of effect from an a-priori intervention period into the placebo period. Therefore, it is important to examine any potential carry-over effects to determine the validity of the study protocol concerning the N-of-1 trial part and thereby justifying recruitment.

Design
Interim analysis for potential carry-over effects.

Setting
Secondary care, 21 participants.

Participants
21 participants, participants concluded part one from the GETSBI study at time of this analysis (October 2023).

Outcome measure
The primary outcome of the study is the change from baseline in pain intensity, measured by visual analogue scale (VAS) pain. To assess for carry-over effects, the placebo responses on VAS pain were compared between groups with (n=10) and without (n=11) potential carry-over effects. The threshold for a clinically relevant carry-over effect was set at a difference on VAS pain >0.50 points. Data were analysed using descriptive statistics, T-tests, effect sizes and 95% CI. Statistical significance was set at α=0.05.

Results
The mean baseline VAS pain did not differ (p=0.12) between group A (n=10, VAS 7.52, SD=0.52) and group B (n=11, VAS 6.02, SD=2.47). The mean placebo responses on VAS pain for groups A and B were 0.97 (SD=1.85) and 1.47 (SD=1.81), respectively. The mean carry-over effect was 0.50 (SD=1.83), which was not statistically significant with a 95% CI of –1.17 to 2.17 and p=0.5369.

Conclusions
This interim analysis shows that an N-of-1 trial probably will be feasible for evaluating non-curative treatment efficacy in chronic disease using only half the patients as are required for a classic RCT. Future analysis will provide a direct comparison of outcomes between the RCT, crossover and the N-of-1 part for a complete evaluation.

Trial registration number
ClinicalTrials.gov, NCT05518864 (GETSBI study).

Objectives
To understand and compare women’s antenatal and postnatal views on: (1) priorities for information provided about labour and delivery and (2) decision-making in labour and delivery.

Design
Qualitative interview study using repeat interviews at two time points: during pregnancy (≥13 weeks gestation); and after birth (≥6 weeks).

Setting
Large maternity hospital in the Southwest of England.

Participants
Pregnant women accessing antenatal care were purposively sampled and recruited antenatally by community midwives to ensure representation from different sociodemographic groups, with diverse experiences of low and high-risk care.

Data collection
Telephone interviews with a single researcher using a semistructured interview topic guide.

Data analysis
Interviews were audio recorded, transcribed verbatim, and qualitative thematic analysis was conducted using Braun and Clarke’s six-stage process.

Results
Twelve women participated (12 antenatal interviews; 10 follow-up postnatal interviews). Overall, women’s postnatal views were consistent with their antenatal views about what they wanted to know and the factors that influence decision-making. Three themes were generated. Theme 1 ‘Sources of information’ presents evidence of how women obtain and use information (sub-themes: ‘social influences’, ‘patient responsibility for information seeking’, ‘NHS vs non-NHS resources’). Theme 2 reports women’s views and experiences of ‘The influence of Healthcare Professionals in decision-making’ (sub-themes ‘patient and professional roles in decision-making’, ‘conflicting advice and preferences’, ‘taking authority in emergency decision-making’). The final theme, theme 3, ‘When, how, and what information women want’ shows women want time to process information (sub-themes ‘when: it’s definitely information and time’, ‘how: presentation of information’, ‘what: information required’). Cross-cutting all themes, we found an unmet need for information to be tailored to the individual.

Conclusions
Women understand decision-making during labour and birth is a dynamic process. Women can struggle with the volume, quality and timing of information available. In busy maternity settings, the challenge is to better equip women with the information they want, and health professionals with the information they need to provide for personalised care and shared decision-making. Antenatal interventions that warrant further research include decision aids, birth plans, and structured counselling using core information sets. Insights from both antenatal and postnatal perspectives will help inform their development.

Introduction
Cervical cancer is a major global health issue. The standard treatment for locally advanced disease involves radiochemotherapy followed by uterovaginal brachytherapy (UBT). UBT requires several days of hospitalisation and strict bed rest. UBT often induces pain, anxiety, stress, distress and a decline in physical capacity during and after treatment. Previous research suggests that non-pharmacological interventions, such as yoga, may help alleviate these issues. However, few studies have specifically evaluated their effectiveness in reducing stress during UBT. Furthermore, patient education has been shown to facilitate autonomous practice and to improve patient empowerment. This study aims to evaluate the impact of the KYOCOL protocol, which integrates both a physiotherapy-yoga intervention and an educational programme, on perceived stress and its correlates in patients undergoing UBT.

Methods and analysis
KYOCOL is an ongoing randomised, prospective trial carried out in three French comprehensive cancer centres, using a quantitative approach complemented by a qualitative component. Eighty patients are planned to be randomised (1:1) into a control arm (standard care) or an intervention arm. In the intervention arm, patients will be educated and supervised by a trained physiotherapist in a physiotherapy-yoga programme and will then perform daily autonomous sessions during UBT and for up to 15 days post-treatment. The primary objective is to assess the impact of the KYOCOL intervention compared with standard care during UBT, on perceived stress 15 days post-UBT, using the 10-item Perceived Stress Scale. Secondary objectives include evaluating the safety of the intervention, its effects on stress, pain and fatigue during UBT, and patient adherence to the programme. Qualitative analyses based on semistructured interview surveys will be conducted to gather valuable information and analyse in depth patients’ experiences with the intervention and UBT.

Ethics and dissemination
This study was approved by the French ethics committee (Comité de Protection des Personnes Ouest V, reference number 2023-A01491-44) on 22 February 2024 and will be carried out in accordance with the good clinical practice guidelines and the Declaration of Helsinki. The results will be shared with patients and healthcare professionals and published in a peer-reviewed journal.

Trial registration number
NCT06263283.

Circulation, Ahead of Print. BACKGROUND:Despite the significant global impact of the COVID-19 pandemic, limited studies have investigated the long-term cardiovascular sequelae of SARS-CoV-2 infection, particularly among Asian populations. This large-scale, population-based binational cohort study with long-term follow-up aimed to investigate the association between SARS-CoV-2 infection and the risk of cardiovascular events.METHODS:We used binational, large-scale, and population-based cohorts, including a Korean nationwide cohort (K-COV-N; discovery cohort; n=18 989 129) and a Japanese nationwide cohort (Japan Medical Data Center; validation cohort; n=12 218 680). Individuals aged 20 years or older were included from January 1, 2020, to December 31, 2022. We assessed the long-term risk of incident cardiovascular outcomes after SARS-CoV-2 infection. The primary outcome was the risk of cardiovascular diseases based onInternational Classification of Diseases, Tenth Revisioncode diagnosis. After propensity score–based overlap weighting, Cox proportional hazard models were used to estimate adjusted hazard ratios for cardiovascular outcomes. We assessed the time attenuation effect of cardiovascular outcomes after SARS-CoV-2 infection. Multiple subgroup analyses were conducted by 16 cardiovascular outcomes, COVID-19 severity, vaccination, and SARS-CoV-2 strain.RESULTS:In the overlap-weighted discovery cohort, 7 960 357 individuals were included (mean age, 48.52 years [SD, 9.33]; men, 4 283 878 [53.82%]). SARS-CoV-2 infection was associated with a long-term increased risk of overall cardiovascular outcomes (adjusted hazard ratio, 1.62 [95% CI, 1.60–1.64]), particularly ischemic heart disease (1.81 [95% CI, 1.77–1.84]), heart failure (1.79 [95% CI, 1.73–1.85]), cerebrovascular disorders (1.65 [95% CI, 1.60–1.69]), major adverse cardiovascular events (1.65 [95% CI, 1.60–1.70]), inflammatory heart diseases (1.53 [95% CI, 1.31–1.80]), dysrhythmia (1.44 [95% CI, 1.42–1.46]), and thrombotic disorders (1.42 [95% CI, 1.35–1.48]). The increased risk persisted up to 18 months, with the highest association observed for 1 to 6 months after infection. The risk of cardiovascular diseases was pronounced with COVID-19 severity; however, it decreased with the administration of complete vaccination and subsequent booster doses. A similar risk of cardiovascular outcomes existed across every SARS-CoV-2 era (pre-delta, delta, and omicron). Similar patterns were observed in the validation cohort. The absolute risk of cardiovascular disease events after SARS-CoV-2 infection remained remarkably low (2.12% versus 1.31% in the noninfected population), particularly stroke (0.24% versus 0.13%) and ischemic heart disease (0.73% versus 0.39%).CONCLUSIONS:This binational study observed associations between SARS-CoV-2 infection and cardiovascular events during extended follow-up across viral eras. Complete vaccination was linked to lower cardiovascular events. However, the absolute risk of cardiovascular disease events after SARS-CoV-2 infection remained remarkably low, particularly for stroke and ischemic heart disease. Although these findings suggest ongoing vigilance and preventive measures remain crucial, they should be interpreted within the context of these low absolute risks when considering long-term cardiovascular complications.

We agree with Guglieri and colleagues that specific recommendations for how low-income countries can improve the quality of care for heart failure are needed. Indeed the REPORT-HF data strongly support the call for a focus on low-income regions in showing that (1) mortality following hospitalization for heart failure was 58% higher in patients from lower-income (vs. higher-income) countries1; (2) attainment of established quality indicators (QIs) was significantly lower in lower-income countries than in higher-income countries.

Objectives
To estimate the proportion and correlates of self-reported financial difficulty among patients with multiple myeloma (MM) or chronic lymphocytic leukaemia (CLL).

Setting
Sixty-six US community and minority oncology practices affiliated with the National Cancer Institute Community Oncology Research Programme (NCORP).

Participants
A total of 521 patients (≥18 years) with MM or CLL consented and 416 responded to a survey (completion rate=79.8%). Respondents had a MM diagnosis (74.0%), an associate degree or higher (53.4%), were White (89.2%), insured (100%) and treated with clinician-administered drugs (68.0%).

Study design
Observational, theoretical model and protocol-based patient survey administered between May 2019 and June 2020.

Primary and secondary outcome measures
Financial difficulty was assessed using a single-item measure, the EORTC QLQC30: ‘Has your physical condition or medical treatment caused you financial difficulties in the past year?’ and using an ‘any-or-none’ composite measure of 22 items assessing financial difficulty, worries and the use of cost-coping strategies. Multivariable logistic regression models assessed the association of financial difficulty with diagnosis, socioeconomic and treatment characteristics.

Results
About 16.8% reported experiencing financial difficulty using the single-item measure and 60.3% using the composite measure. Most frequently endorsed items in the composite measure were financial worry about having to pay large medical bills related to cancer and difficulty paying medical bills. Financial difficulty using the single-item measure was associated with having MM vs CLL (adjusted OR (aOR), 0.34; 95% CI, 0.13 to 0.84; p=0.02), having insurance other than Medicare (aOR, 2.53; 95% CI, 1.37 to 4.66; p=0.003), being non-White (aOR, 2.21; 95% CI, 1.04 to 4.72; p=0.04) and having a high school education or below (aOR, 0.36; 95% CI, 0.21 to 0.64; p=0.001). Financial difficulty using the composite measure was associated with having a high school education or below (aOR, 0.62; 95% CI, 0.41 to 0.94; p=0.03).

Conclusions
US patients with MM and CLL report financial difficulty, especially those with low socio-economic status. Interventions are needed to mitigate patients’ financial difficulty.

Trial registration number
NCT03870633.

Annals of Internal Medicine, Ahead of Print.

Our findings suggest that monthly IPTp-SP has superior effect on GWG compared to weekly chloroquine or IPTp-DHA + PPQ in malaria-endemic areas. The result provides further evidence indicating that IPTp-SP improves maternal weight gain, an important determinant of fetal growth beyond its antimalarial effects. Due to the limited number of trials with weight and height measures available for the IPD meta-analysis we were likely underpowered to detect any significant difference between 2-dose SP and monthly IPTp-SP.

Uptake of nirsevimab varied substantially between the countries that have implemented infant RSV immunisation programmes. Despite the limited number of studies and the lack of more accurate data at national level the low uptake estimates for RSV maternal vaccine and RSV vaccines for older adults are concerning. National, clinical, and public health initiatives are needed to increase uptake of RSV immunisation products and ensure maximum benefit to people currently at risk of severe RSV outcomes.

The REPORT-HF registry evaluated the quality of care (QoC) in acute heart failure and its association with outcomes across 44 countries.1 The authors conclude that improving QoC could reduce mortality in acute heart failure. While this is a reasonable assertion, specific recommendations for how low-income countries can achieve this improvement are needed.2,3 Among targeted strategies for quality improvement that may increase the practical impact, it is suggested that NYHA classification (despite its limitations) and its routine assessment in HF with minimal cost should be promoted.

In Reply In response to the Letter by Ms Chen and colleagues about our recent study, we concur that severe maternal morbidity conditions can arise from both preexisting maternal conditions (eg, cardiac complications) and pregnancy-induced conditions (eg, severe sepsis). Addressing preexisting conditions through targeted preconception and antenatal care, such as prescribing low-dose aspirin to reduce severe preeclampsia, is essential. Early identification of high-risk individuals (eg, women with a history of psychiatric disorders) could potentially improve maternal outcomes. Furthermore, as Chen and colleagues highlight, the effect of interpregnancy interval warrants attention, given that long-term clinical follow-up and reproductive counseling may alleviate the risk of severe maternal morbidity in subsequent pregnancies.

Snow fell overnight, a deep slush like the red sludge my uterus sheds after tumor removal. In a year they will grow back.

This Perspective examines the rapid adoption of DeepSeek, a large language model, across Chinese hospitals and the regulatory and governance concerns surrounding the use of artificial intelligence–enabled models in health care.

In a rabbit endocarditis model, low-dose daptomycin plus cloxacillin or ceftaroline resulted in valve sterilization in ≥90% of animals without development of daptomycin nonsusceptibility.