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This cohort study investigates the association of ERBB-2 expression with clinicopathologic characteristics and prognosis among patients with ERBB2-low and ERBB2-0 breast cancer.
In Reply We thank Drs Andrikopoulos and Vlachopoulos for their consideration of our systematic review and meta-analyses. The following should address their points. The correspondents state that “[p]ooling of studies with different clinical contexts may lead to erroneous conclusions.” This issue of clinical heterogeneity is clearly addressed in our article; we identified and acknowledged the “significant clinical and statistical heterogeneity,” which had “received little or no attention in prior meta-analyses.” We reiterate now that influential clinical guidelines are predicated on the results of meta-analyses of aggregate trial data and individual patient data, using largely the same trials. We classified sources of clinical heterogeneity as those that were likely associated with low-density lipoprotein cholesterol (LDL-C) reduction and those that were not, and argued that,
To the Editor We read with interest the systematic review and meta-analysis by Dr Byrne and colleagues. Although the authors conclude that “the absolute benefits of statins are modest,” we identified factors that weaken their argument. Pooling of studies with different clinical contexts may lead to erroneous conclusions. Accordingly, of the 21 randomized clinical trials included, only 6 were secondary prevention trials in which the effect of statins on prognosis was more potent. Furthermore, the specific limitations of the included studies cast doubt on the conclusions. The CORONA (Controlled Rosuvastatin Multinational Trial in Heart Failure) study, which enrolled patients with advanced heart failure, reported 193 deaths from worsening heart failure in the rosuvastatin group vs 15 deaths from myocardial infarction and 35 deaths from stroke. The GISSI-HF (Gruppo Italiano per lo Studio della Sopravvivenza nella Insufficienza Cardiaca) trial, another heart failure study, was also included. The MEGA (Management of Elevated Cholesterol in the Primary Prevention Group of Adult Japanese) trial, conducted among a population in Japan, had an event rate of 0.16 per 100 patient-years in the control group. Lastly, the ALLHAT-LLT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) was nonblinded.
In this issue of JAMA Oncology, Shore et al present the results of the ENACT randomized phase 2 clinical trial. Between June 2016 and August 2020, 227 men with prostate cancer were randomized with equal probability to either undergo active surveillance alone (AS) or receive treatment with enzalutamide plus AS. The median age at randomization was 65 years, and 53% of patients had low-risk cancer as determined by the National Comprehensive Cancer Network guidelines. Patients in the treatment arm were treated with enzalutamide, 160 mg, for 1 year with an initial follow-up for 1 year and a second year of follow-up for remaining patients in the trial. The primary end point was time to pathological or therapeutic prostate cancer progression. Pathological progression in the study was defined as an increase in primary or secondary Gleason pattern by at least 1 or higher proportion of cancer-positive cores (≥15% increase). Therapeutic progression was considered on primary therapy for prostate cancer whether this was prostatectomy, radiation, focal therapy, or any systemic therapy.
This randomized clinical trial examines the efficacy and safety of enzalutamide monotherapy vs active surveillance in patients with low-risk or intermediate-risk prostate cancer.
In this issue of JAMA Oncology, Fitzgerald Jones et al publish the results of a Delphi consensus panel on the management of pain in patients with advanced cancer in the context of opioid use disorder or nonmedical opioid use.
This case report describes the electrocardiogram findings of a patient in their 50s with a history of hypertension and dyslipidemia who presented to the emergency department with sudden chest pain and weakness.
This cross-sectional study compiles use and cost data of low-value health services delivered or paid for by the Veterans Health Administration (VA).
Objective
To assess the bidirectional association between chronic pain and both subjectively and objectively measured physical activity (PA).
Design
Cross-sectional study.
Setting
Population-based sample in Lausanne, Switzerland, May 2014 to April 2017.
Participants
Non-stratified, representative sample of the population of Lausanne (Switzerland) aged 35–75 years. Participants were excluded if they had missing data for the pain or the PA questionnaires, for accelerometry (defined as >20% of non-wear time or duration
Objective
To describe missed opportunities for vaccination (MOV) among children visiting Médecins Sans Frontières (MSF)-supported facilities, their related factors, and to identify reasons for non-vaccination.
Design
Cross-sectional surveys conducted between 2011 and 2015.
Setting and participants
Children up to 59 months of age visiting 19 MSF-supported facilities (15 primary healthcare centres and four hospitals) in Afghanistan, Democratic Republic of the Congo, Mauritania, Niger, Pakistan and South Sudan. Only children whose caregivers presented their vaccination card were included.
Outcome measures
We describe MOV prevalence and reasons for no vaccination. We also assess the association of MOV with age, type of facility and reason for visit.
Results
Among 5055 children’s caregivers interviewed, 2738 presented a vaccination card of whom 62.8% were eligible for vaccination, and of those, 64.6% had an MOV. Presence of MOV was more likely in children visiting a hospital or a health facility for a reason other than vaccination. MOV occurrence was significantly higher among children aged 12–23 months (84.4%) and 24–59 months (88.3%) compared with children below 12 months (56.2%, p≤0.001). Main reasons reported by caregivers for MOV were lack of vaccines (40.3%), reason unknown (31.2%) and not being informed (17.6%).
Conclusions
Avoiding MOV should remain a priority in low-resource settings, in line with the new ‘Immunization Agenda 2030’. Children beyond their second year of life are particularly vulnerable for MOV. We strongly recommend assessment of eligibility for vaccination as routine healthcare practice regardless of the reason for the visit by screening vaccination card. Strengthening implementation of ‘Second year of life’ visits and catch-up activities are proposed strategies to reduce MOV.
Introduction
Menopause denotes the end of a woman’s reproductive life. A woman’s experiences of menopause are shaped by her individual circumstances and may vary between social and cultural contexts. Evidence is needed to inform research and programme delivery that supports women’s health and well-being throughout the menopausal transition. This scoping review will map evidence of women’s experiences of menopause in Asia Pacific countries, where limited research exists.
Methods and analysis
We will follow the five-stage framework of Arksey and O’Malley, further developed by Levac et al and the Joanna Briggs Institute. MEDLINE, CINAHL, PsycINFO and Scopus databases will be systematically searched between February 2022 and May 2022 using subject headings and keywords. The title–abstract and full text of retrieved studies will be assessed against eligibility criteria. The review will focus on studies with a qualitative research component. Citation searching of selected articles will supplement database searching. Data will be extracted, charted, synthesised and summarised. Findings will be presented in narrative format and implications for research and practice reported.
Ethics and dissemination
Ethical approval is not required for this scoping review of selected studies from peer-reviewed journals. Ethical approval has been granted from relevant ethics committees for community consultation. Findings will be shared in peer-reviewed publications, presented at conferences and disseminated with communities, health workers and researchers.
Introduction
Chronic musculoskeletal pain (CMP) is described as pain that persists for longer than 3 months. At present, no research is available that understands why CMP develops and continues from the perspective of the individual. Research is needed to establish if there are any consistent biopsychosocial factors perceived as contributing to CMP and what informs such beliefs. Understanding individual beliefs will inform more effective communication between clinicians and patients about their CMP, as well as informing future research into the epidemiology of CMP. Interpretative phenomenological analysis will be used as a methodological framework as it explores how individuals make sense of their world through personal experiences and perceptions while preserving individual nuance. The aim of this study is to understand individuals’ beliefs and perceptions about the biological, psychological and social factors, which contribute to the development and maintenance of their CMP.
Methods and analysis
A qualitative study informed by the Consolidated Criteria for Reporting Qualitative Research using interpretative phenomenological analysis and semistructured interviews. A maximum variation purposive sample of 6–12 adults with CMP will be recruited from the general public in the UK. One semistructured interview will be conducted with each participant via an online video platform with interviews transcribed verbatim. The interview schedule (codesigned with expert patients and informed by existing evidence) identifies three domains of important questions; (1) patient beliefs on why they developed and continue to experience CMP; (2) the relationship between their biopsychosocial experiences and CMP; and (3) the origin of their beliefs. Strategies such as ‘member checking’ will be employed to ensure trustworthiness.
Ethics and dissemination
Ethical approval was granted by the Research Ethics Office at the University of Birmingham (reference ERN_21-0813). Informed consent will be obtained from all participants. The study findings will be submitted for publication in a peer-reviewed journal and for presentation at conferences.
Introduction
Pneumocystis jirovecii pneumonia (PJP) is an opportunistic infection of immunocompromised hosts with significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15–20 mg/kg/day, is associated with serious adverse drug events (ADE) in 20%–60% of patients. ADEs include hypersensitivity reactions, drug-induced liver injury, cytopenias and renal failure, all of which can be treatment limiting. In a recent meta-analysis of observational studies, reduced dose TMP-SMX for the treatment of PJP was associated with fewer ADEs, without increased mortality.
Methods and analysis
A phase III randomised, placebo-controlled, trial to directly compare the efficacy and safety of low-dose TMP-SMX (10 mg/kg/day of TMP) with the standard of care (15 mg/kg/day of TMP) among patients with PJP, for a composite primary outcome of change of treatment, new mechanical ventilation, or death. The trial will be undertaken at 16 Canadian hospitals. Data will be analysed as intention to treat. Primary and secondary outcomes will be compared using logistic regression adjusting for stratification and presented with 95% CI.
Ethics and dissemination
This study has been conditionally approved by the McGill University Health Centre; Ethics approval will be obtained from all participating centres. Results will be submitted for publication in a peer-reviewed journal.
Trial registration number
NCT04851015.
Introduction
Newborn infants routinely undergo minor painful procedures as part of postnatal care, with infants born sick or premature requiring a greater number of procedures. As pain in early life can have long-term neurodevelopmental consequences and lead to parental anxiety and future avoidance of interventions, effective pain management is essential. Non-pharmacological comfort measures such as breastfeeding, swaddling and sweet solutions are inconsistently implemented and are not always practical or effective in reducing the transmission of noxious input to the brain. Stroking of the skin can activate C-tactile fibres and reduce pain, and therefore could provide a simple and safe parent-led intervention for the management of pain. The trial aim is to determine whether parental touch prior to a painful clinical procedure provides effective pain relief in neonates.
Methods and analysis
This is a multicentre randomised controlled trial. A total of 112 neonates born at 35 weeks’ gestation or more requiring a blood test in the first week of life will be recruited and randomised to receive parental stroking either preprocedure or postprocedure. We will record brain activity (EEG), cardiac and respiratory dynamics, oxygen saturation and facial expression to provide proxy pain outcome measures. The primary outcome will be the reduction of noxious-evoked brain activity in response to a heel lance. Secondary outcomes will be a reduction in clinical pain scores (Premature Infant Pain Profile-Revised), postprocedural tachycardia and parental anxiety.
Ethics and dissemination
The study has been approved by the London—South East Research Ethics Committee (ref: 21/LO/0523). The results will be widely disseminated through peer-reviewed publications, international conferences and via our partner neonatal charities Bliss and Supporting the Sick Newborn And their Parents (SSNAP). If the parental tactile intervention is effective, recommendations will be submitted via the National Health Service clinical guideline adoption process.
Study status
Commenced September 2021.
Trial registration number
NCT04901611; 14 135 962.
Question: A 63-year-old man, with a history of Child-Pugh A cirrhosis related to alcohol and previously treated hepatitis C, was admitted at a tertiary center for an elective transarterial chemoembolization (TACE). In the context of a significantly elevated alpha-fetoprotein of 1300 kU/L and having been lost to follow-up for several years, a computed tomographic (CT) and magnetic resonance imaging liver quad-phase scan confirmed the presence of 2 lesions in segments 5 and 7, both measuring approximately 18 mm, consistent with hepatocellular carcinoma (HCC).
Objectives
This study investigates the association of daily physical exercise with pain symptoms in endometriosis. We also examined whether an individual’s typical weekly (ie, habitual) exercise frequency influences (ie, moderates) the relationship between their pain symptoms on a given day (day t) and previous-day (day t-1) exercise.
Participants
The sample included 90 382 days of data from 1009 participants (~85% non-Hispanic white) living with endometriosis across 38 countries.
Study design
This was an observational, retrospective study conducted using data from a research mobile app (Phendo) designed for collecting self-reported data on symptoms and self-management of endometriosis.
Primary outcome measures
The two primary outcomes were the composite day-level pain score that includes pain intensity and location, and the change in this score from previous day (-score). We applied generalised linear mixed-level models to examine the effect of previous-day exercise and habitual exercise frequency on these outcomes. We included an interaction term between the two predictors to assess the moderation effect, and adjusted for previous-day pain, menstrual status, education level and body mass index.
Results
The association of previous-day (day t-1) exercise with pain symptoms on day t was moderated by habitual exercise frequency, independent of covariates (rate ratio=0.96, 95% CI=0.95 to 0.98, p=0.0007 for day-level pain score, B=–0.14, 95% CI=–0.26 to –0.016, p=0.026 for -score). Those who regularly engaged in exercise at least three times per week were more likely to experience favourable pain outcomes after having a bout of exercise on the previous day.
Conclusions
Regular exercise might influence the day-level (ie, short-term) association of pain symptoms with exercise. These findings can inform exercise recommendations for endometriosis pain management, especially for those who are at greater risk of lack of regular exercise due to acute exacerbation in their pain after exercise.
