Autore/Fonte: The Surgery Journal
Gestione chirurgica della pancreatite acuta
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Dicembre 2022
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Autore/Fonte: The Surgery Journal
This cohort study assesses the interventions and patient factors associated with emergency department return following an initial emergency department visit for hidradenitis suppurativa.
Introduction
The variety, time patterns and long-term prognosis of persistent COVID-19 symptoms (long COVID-19) in patients who suffered from mild to severe acute COVID-19 are incompletely understood. Cohort studies will be combined to describe the prevalence of long COVID-19 symptoms, and to explore the pathophysiological mechanisms and impact on health-related quality of life. A prediction model for long COVID-19 will be developed and internally validated to guide care in future patients.
Methods and analysis
Data from seven COVID-19 cohorts will be aggregated in the longitudinal multiple cohort CORona Follow Up (CORFU) study. CORFU includes Dutch patients who suffered from COVID-19 at home, were hospitalised without or with intensive care unit treatment, needed inpatient or outpatient rehabilitation and controls who did not suffer from COVID-19. Individual cohort study designs were aligned and follow-up has been synchronised. Cohort participants will be followed up for a maximum of 24 months after acute infection. Next to the clinical characteristics measured in individual cohorts, the CORFU questionnaire on long COVID-19 outcomes and determinants will be administered digitally at 3, 6, 12, 18 and 24 months after the infection. The primary outcome is the prevalence of long COVID-19 symptoms up to 2 years after acute infection. Secondary outcomes are health-related quality of life (eg, EQ-5D), physical functioning, and the prevalence of thromboembolic complications, respiratory complications, cardiovascular diseases and endothelial dysfunction. A prediction model and a patient platform prototype will be developed.
Ethics and dissemination
Approval was obtained from the medical research ethics committee of Maastricht University Medical Center+ and Maastricht University (METC 2021-2990) and local committees of the participating cohorts. The project is supported by ZonMW and EuroQol Research Foundation. Results will be published in open access peer-reviewed scientific journals and presented at (inter)national conferences.
Trial registration number
NCT05240742.
Objectives
Internet-based interventions are often hampered by high dropout rates. The number of individuals who decline to participate or dropout are reported, but reasons for dropout are not. Identification of barriers to participation and predictors of dropout may help improve the efficacy of internet-based clinical trials. The aim was to investigate a large number of possible predictors for non-participation and dropout in a randomised controlled trial for women with a negative birth experience and/or post-traumatic stress following childbirth.
Setting
A childbirth clinic at a university hospital in Sweden.
Participants
The sample included 1523 women who gave birth between September 2013 and February 2018. All women who rated an overall negative birth experience on a Likert scale, and/or had an immediate caesarean section (CS), and/or severe postpartum haemorrhage (≥ 2000 mL) were eligible.
Methods
Demographic, antepartum, and labour-related/postpartum predictors were investigated for non-participation (eligible but denied participation), pre-treatment dropout (prior to intervention start), treatment dropout, and loss to follow-up. Descriptive statistics and logistic regression were used in the data analysis.
Results
A majority (80.3 %) were non-participants. Non-participation was predicted by lower level of education, being foreign-born, no experience of counselling for fear of childbirth, multiparity, vaginal delivery (vs CS and vacuum-assisted delivery) and absence of: preeclampsia, anal sphincter injury and intrapartum fetal distress. Pretreatment dropout was predicted by the absence of severe haemorrhage. Treatment dropout was predicted by vaginal delivery (vs immediate CS), vertex presentation and good overall birth experience. Loss to follow-up was predicted by vaginal delivery (vs immediate CS or vacuum-assisted delivery) and absence of intrapartum fetal distress.
Conclusions
Mothers with no obstetric complications were more likely to not participate and dropout at different time points. Both demographic, antepartum and obstetrical variables are important to attend to while designing procedures to maximise participation in internet-delivered cognitive–behavioral therapy.
Trial registration number
ISRCTN39318241
Objectives
The main objective was to investigate 5-year outcomes in patients with knee osteoarthritis, randomised to one of two non-surgical treatments.
Setting
Two outpatient clinics.
Participants
At baseline, 100 patients with radiographic and symptomatic knee osteoarthritis not found eligible for knee replacement (KR) were included. Main exclusion criteria were average score above 75 of the Knee injury and Osteoarthritis Outcome Score (KOOS) subscales pain, symptoms, function of daily living and quality of life; KOOS4 and average knee pain the previous week greater than 60 mm on a 100 mm visual analogue scale.
Interventions
Patients were randomised to supervised non-surgical treatment consisting of patient education, supervised exercise, weight loss, insoles, and pain medication (the MEDIC treatment) or written advice. The 12-week MEDIC treatment included patient education, neuromuscular exercise, insoles and a dietary weight loss programme and/or pain medication if needed and written advice consisted of two leaflets.
Primary and secondary outcome measures
Primary outcome was 5-year mean change for KOOS4. Secondary outcomes included KOOS subscales, self-reported health, usage of pain medication and self-reported physical activity.
Results
Thirty-nine (78%) and 36 (72%) from the MEDIC and written advice groups responded at 5 years. There were no between-group differences in KOOS4 (difference 5.3 (95% CI –1.5 to 12.1) or any secondary outcomes. However, the 95% CI included the minimal clinically important difference for the main outcome.
Seventy-six percent of the MEDIC group and 66% of the written advice group experienced clinically important improvements in KOOS4.
Fifteen patients (30%) from the MEDIC group and 17 (34%) from the written advice group received KR in the index knee. Undergoing KR did not result in a statistically significant greater improvement in KOOS4 (difference 6.1 (95% CI –1.1 to 13.4).
Conclusions
No statistically significant differences between supervised non-surgical treatment and written advice were demonstrated at 5 years. Most patients experienced clinically important improvements, irrespective of initial treatment strategy or KR.
Trial registration number
NCT01535001; ClinicalTrials.gov.
Objective
This study aimed to understand the barriers and facilitators of a neonatal follow-up programme, as perceived by parents of infants born with hypoxic ischaemic encephalopathy (HIE).
Design
This study applied a qualitative study design using interpretative phenomenological analysis. It included focus group discussions, face-to-face in-depth interviews and telephonic interviews. Data were analysed using thematic content analysis.
Setting
Neonatal follow-up clinic of a tertiary hospital in South India. The study was conducted between March and December 2020.
Participants
Five fathers and eight mothers of infants with HIE.
Results
Parents of children with HIE are torn between two worlds—an atmosphere of support and one of criticism. Three main themes were identified: (1) neonatal intensive care unit (NICU) stay: distressful versus reassuring experiences; (2) parenthood: supportive versus unsupportive environments; and (3) neonatal follow-up: adherence versus non-adherence.
Conclusion
Parents of children with HIE experience sociocultural barriers in the NICU, after discharge and during the follow-up period. These lead to a complex array of emotional and physical consequences that affect parenting and follow-up care.
Autore/Fonte: J. Ultrasound Med.
This study examines adverse events and durability of response of SER-109, an investigational microbiome therapeutic comprised of purified Firmicutes spores, compared with placebo for Clostridioides difficile infection.
Objective
We undertook a systematic review of strategies adopted to scale up COVID-19 testing in countries across income levels to identify successful approaches and facilitate learning.
Methods
Scholarly articles in English from PubMed, Google scholar and Google search engine describing strategies used to increase COVID-19 testing in countries were reviewed. Deductive analysis to allocate relevant text from the reviewed publications/reports to the a priori themes was done.
Main results
The review covered 32 countries, including 11 high-income, 2 upper-middle-income, 13 lower-middle-income and 6 low-income countries. Most low- and middle-income countries (LMICs) increased the number of laboratories available for testing and deployed sample collection and shipment to the available laboratories. The high-income countries (HICs) that is, South Korea, Germany, Singapore and USA developed molecular diagnostics with accompanying regulatory and legislative framework adjustments to ensure the rapid development and use of the tests. HICs like South Korea leveraged existing manufacturing systems to develop tests, while the LMICs leveraged existing national disease control programmes (HIV, tuberculosis, malaria) to increase testing. Continent-wide, African Centres for Disease Control and Prevention-led collaborations increased testing across most African countries through building capacity by providing testing kits and training.
Conclusion
Strategies taken appear to reflect the existing systems or economies of scale that a particular country could leverage. LMICs, for example, drew on the infectious disease control programmes already in place to harness expertise and laboratory capacity for COVID-19 testing. There however might have been strategies adopted by other countries but were never published and thus did not appear anywhere in the searched databases.
Introduction
Long-term survival after childhood cancer often comes at the expense of late, adverse health conditions. However, survivorship care is frequently not available for adult survivors in Europe. The PanCareFollowUp Consortium therefore developed the PanCareFollowUp Care Intervention, an innovative person-centred survivorship care model based on experiences in the Netherlands. This paper describes the protocol of the prospective cohort study (Care Study) to evaluate the feasibility and the health economic, clinical and patient-reported outcomes of implementing PanCareFollowUp Care as usual care in four European countries.
Methods and analysis
In this prospective, longitudinal cohort study with at least 6 months of follow-up, 800 childhood cancer survivors will receive the PanCareFollowUp Care Intervention across four study sites in Belgium, Czech Republic, Italy and Sweden, representing different healthcare systems. The PanCareFollowUp Care Intervention will be evaluated according to the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Clinical and research data are collected through questionnaires, a clinic visit for multiple medical assessments and a follow-up call. The primary outcome is empowerment, assessed with the Health Education Impact Questionnaire. A central data centre will perform quality checks, data cleaning and data validation, and provide support in data analysis. Multilevel models will be used for repeated outcome measures, with subgroup analysis, for example, by study site, attained age, sex or diagnosis.
Ethics and dissemination
This study will be conducted in accordance with the guidelines of Good Clinical Practice and the Declaration of Helsinki. The study protocol has been reviewed and approved by all relevant ethics committees. The evidence and insights gained by this study will be summarised in a Replication Manual, also including the tools required to implement the PanCareFollowUp Care Intervention in other countries. This Replication Manual will become freely available through PanCare and will be disseminated through policy and press releases.
Trial registration number
Netherlands Trial Register (NL8918; https://www.trialregister.nl/trial/8918).
Introduction
The use of patient-reported outcome measures (PROMs) in clinical practice has the potential to promote person-centred care and improve patients’ health-related quality of life. We aimed to develop an intervention centred around electronic PROMs (ePROMs) for systematic follow-up in patients diagnosed with breast cancer and to evaluate its feasibility.
Methods and analysis
We developed a nurse-oriented and surgeon-oriented intervention in PROMs, including (1) an education programme for nurses and surgeons; (2) administration of BREAST-Q as proactive ePROMs during follow-up in patients diagnosed with breast cancer and (3) feedback to nurses and surgeons on PROM scores and a guidance manual for healthcare practitioners. Subsequently, we designed a non-controlled feasibility evaluation on the outcomes acceptability, demand, implementation, practicality and integration. The feasibility evaluation includes qualitative ethnographic studies exploring the user perspectives of patients, nurses and surgeons and quantitative studies to explore the characteristics of the patient population regarding demographic background, response rates and response patterns. The feasibility study was initiated in September 2021, will continue until 2024 and will include approximately 900 patients. EPROMs are collected at the following assessment time points: baseline (after diagnosis, before surgery), 1-year follow-up and 3-year endpoint.
Ethics and dissemination
The study will be conducted according to the General Data Protection Regulation and the fifth version of the Helsinki Declaration. The National Committee on Health Research Ethics approved the study according to the law of the Committee § 1, part 4. All data will be anonymised before its publication. The results of the feasibility study will be published in peer-reviewed, international journals.
Annals of Internal Medicine, Ahead of Print.
Annals of Internal Medicine, Volume 175, Issue 12, Page 1756-1758, December 2022.
Introduction
Wake-up stroke (WUS) is a type of acute ischaemic stroke (AIS) that occurs during sleep with unknown time of symptom onset. The best treatment is usually not suitable for WUS, as thrombolysis is usually provided to patients who had a symptomatic AIS within a definite 4.5 hours, and WUS remains a therapeutic quandary. Efforts to explore the onset time characteristics of patients who had a WUS and the risk factors affecting poor prognosis support a role for providing new insights by performing multicentre cohort study.
Methods and analysis
This multicentre, nationwide prospective registry will include 21 comprehensive stroke centres, with a goal of recruiting 550 patients who had a WUS in China. In this study, clinical data including patient’s clinical characteristics, stroke onset time, imaging findings, therapeutic interventions and prognosis (the National Institutes of Health Stroke Scale Score and the modified Rankin Scale Score at different time points) will be used to develop prediction models for stroke onset time and prognostic evaluation using the fast-processing of ischemic stroke software. The purpose of this study is to identify risk factors influencing prognosis, to investigate the relationship between the time when the symptoms are found and the actual onset time and to establish an artificial intelligence-based model to predict the prognosis of patients who had a WUS.
Ethics and dissemination
This study is approved by the ethics committee of Shanghai Pudong Hospital (Shanghai, China) and rest of all participating centres. The findings will be disseminated through peer-reviewed publications and conference presentations.
PROSPERO registration number
ChiCTR2100049133.
Objective
The use of maternal health services is an important indicator of maternal health and socioeconomic development. Evidence on individual-level and community-level determinants of use of maternal health services in Benishangul Gumuz Region was not well known so far. Hence, this study fills this gap.
Design
A prospective follow-up study
Setting
This study was conducted from March 2020 to January 2021 in Northwest Ethiopia.
Participants
A total of 2198 pregnant women participated in the study.
Main outcome measures
A multistage random sampling technique was used to select study subjects. Data were collected via face-to-face interviews using pretested semistructured questionnaires. Collected data were coded, cleaned and analysed using Stata software. Multilevel regression models were applied to determine individual-level and community-level factors of use of maternal health services.
Results
This study found that the proportions of women who visited recommended antenatal care (ANC), received skilled delivery care and postnatal care (PNC) were 66.1%, 58.3% and 58.6%, respectively. Being rural (adjusted OR (AOR)=3.82, 95% CI 1.35 to 10.78), having information on maternal health services (AOR=2.13, 95% CI 1.21 to 3.75), with a history of pregnancy-related problems (AOR=1.83, 95% CI 1.15 to 2.92) and women with decision-making power (AOR=1.74, 95% CI 1.14 to 2.68) were more likely to attend fourth ANC visits. Similarly, women who attended tertiary school (AOR=4.12, 95% CI 1.49 to 11.33) and who initiated the first ANC visit within 4–6 months of pregnancy (AOR=0.66, 95% CI 0.45 to 0.96) were determinants of skilled delivery care. Finally, women whose partners attended tertiary education (AOR=3.67, 95% CI 1.40 to 9.58), women with decision-making power (AOR=1.8, 95% CI 1.09 to 2.97), women who attended the fourth ANC visit (AOR=10.8, 95% CI 6.79 to 17.2), women received iron–folic acid during pregnancy (AOR=1.96, 95% CI 1.11 to 3.49) and women who received skilled delivery care (AOR=1.63, 95% CI 1.1 to 2.42) were more likely to get PNC services.
Conclusion
The proportion of women who attended ANC, received skilled delivery services and PNCs was low. Different individual-level and community-level factors that influenced the use of these services were discovered. Therefore, community-based interventions should target those identified factors to improve maternal health services.
New England Journal of Medicine, Ahead of Print.