10-year follow-up results of the European Achalasia Trial: a multicentre randomised controlled trial comparing pneumatic dilation with laparoscopic Heller myotomy

Objective
As achalasia is a chronic disorder, long-term follow-up data comparing different treatments are essential to select optimal clinical management. Here, we report on the 10-year follow-up of the European Achalasia Trial comparing endoscopic pneumodilation (PD) with laparoscopic Heller myotomy (LHM).

Design
A total of 201 newly diagnosed patients with achalasia were randomised to either a series of PDs (n=96) or LHM (n=105). Patients completed symptom (Eckardt score) and quality-of-life questionnaires, underwent functional tests and upper endoscopy. Primary outcome was therapeutic success defined as Eckardt score

Leggi
Marzo 2024

Can we develop consensus on long-term follow-up and surveillance of primary shoulder arthroplasty? A study protocol using a real-time Delphi technique among expert clinicians in the UK

Background
Shoulder arthroplasty incidence is projected to continue its exponential growth and the resultant burden of monitoring patients with shoulder arthroplasty implants creates significant pressure on orthopaedic services. Surveillance offers the opportunity to study implant longevity, detect failing implants and potentially perform revision at lower morbidity and cost. There is a paucity of evidence to support recommendations on long-term follow-up in shoulder arthroplasty. Prospective studies comparing long-term follow-up and structure are impractical from time, resource and cost perspectives. A real-time Delphi technique represents a mechanism by which experts involved in long-term follow-up of primary shoulder arthroplasty can formulate recommendations via a transparent, reproducible and efficient process. We outline the protocol for a real-time Delphi study seeking consensus on long-term follow-up and surveillance of primary shoulder arthroplasty .

Methods
A real-time Delphi technique will be used. A planning committee will design the Delphi statements. A steering committee will supervise and monitor the real-time Delphi process. Participants will be asked to rate their agreement with statements using a 5-point Likert scale. The Delphi statements will be derived from review of published literature, and the strength of evidence available for each statement will be provided. We will offer participation to all surgeons and extended-scope practitioners who are current members of the British Elbow & Shoulder Society (BESS) and have clinical practice involving shoulder arthroplasty follow-up. The questionnaire will be active for 4 weeks and requires a minimum of 20 participants. Consensus agreement is defined as 70% of participants selecting at least a 4-point on a 5-point Likert scale.

Discussion
We anticipate the outlined study will achieve consensus on long-term follow-up and surveillance of primary shoulder arthroplasty. We intend to use the expert consensus recommendations achieved, in addition to the limited applicable published evidence available, to produce BESS-affiliated guidelines on long-term follow-up and surveillance of primary shoulder arthroplasty.
Ethics
Ethical approval is not required for the real-time Delphi study.
We expect the results of this initiative will be published in a peer-reviewed, high-impact journal.

Leggi
Febbraio 2024

Mortality and health-related quality of life in older adults with long-term use of opioids, z-hypnotics or benzodiazepines: a prospective observational study at 5 years follow-up

Objectives
Disease and medication use in older age is a consequence of age-related declining health. Multimorbidity followed by polypharmacy is common. Central nervous system depressing (CNSD) drugs such as opioids, benzodiazepines and z-hypnotics are not recommended for long-term use in older adults but are in use by many. We aimed to assess mortality and change in health-related quality of life (HRQoL) in older adults with long-term use of CNSDs.

Method
A prospective observational study was conducted at Akershus University Hospital, Norway, 2017–2019, with follow-up in 2021–2022, including 246 participants aged 65–90. At 5-year follow-up, 78 (32%) participants had passed away. Mortality data were collected from patient electronic health records. Of the surviving 168 (68%), we collected further follow-up data from 38 (16%) participants. Follow-up included demographic and clinical data. The EuroQuol Group EQ-5D-5L questionnaire was used to measure HRQoL. Analysis include Cox regression model for survival data and linear mixed model for change in HRQoL over time.

Results
At follow-up, 78 (31.7%) were deceased. Mean survival time was 3.3 years. Total time for survival data was 4.7 years. Mortality was higher among participants with long-term use of CNSD (HR 1.9 95% CI (1.2 to 3.2), p=0.01). The multivariable analysis found being older (HR 1.1 95% CI (1.0 to 1.1), p=0.020) and male sex (HR 2.1 95% CI (1.2 to 3.5), p=0.008) to be associated with increased risk of mortality. According to the linear mixed model (n=38), there was no significant difference between surviving users and non-users in change in HRQoL EQ-5D-5L index from baseline to follow-up.

Conclusion
Mortality was higher for long-term users of CNSDs at 5-year follow-up. Being older and male sex were associated with mortality. Among survivors, there was no significant difference between the groups in change of HRQoL over time.

Trial registration number
NCT03162081; 22 May 2017.

Leggi
Febbraio 2024

Orthopaedic trauma patients experiences with emergency department care and follow-up through Virtual Fracture Care review: a qualitative study

Objectives
This study aimed to identify factors influencing orthopaedic trauma patients’ experiences and satisfaction with emergency department (ED) care and follow-up through Virtual Fracture Care (VFC) review workflow.

Design
This study employed an explorative, descriptive, qualitative design using individual, semistructured interviews.

Setting
An urban level 2 trauma centre and teaching hospital in Amsterdam, the Netherlands.

Participants
Eligible patients were Dutch-speaking or English-speaking orthopaedic trauma patients, aged 18 years or above, who visited the hospital’s ED between June and September 2022, and were treated through VFC review workflow. Exclusion criteria were: reason for follow-up other than injury, eye/motor/verbal score

Leggi
Febbraio 2024

Lessons learnt and best practices in scaling up an emergency transportation system to tackle maternal and neonatal mortality: a qualitative study of key stakeholders in Shinyanga, Tanzania

Objective
This study aimed to document lessons learnt and best practices for scaling up an innovative emergency transportation system, drawing insights from the m-mama programme implemented in Shinyanga, Tanzania. The m-mama pilot programme was implemented in phases from 2014 to 2016 in two districts and later scaled up to include all districts in Shinyanga region in 2017. The programme employed an emergency transportation system and technical and operational support of the health system to address the three delays leading to maternal and neonatal mortality.

Design
Cross-sectional, qualitative research with key healthcare system stakeholders from the national, regional and district levels.

Setting
The study was conducted in Kahama and Kishapu districts in Shinyanga, Tanzania. The two districts were selected purposefully to represent the programme implementation districts’ rural and urban or semiurban settings.

Participants
District, regional and national stakeholders involved in implementing the m-mama pilot programme in Shinyanga were interviewed between February and March 2022.

Results
Lessons learnt from implementing the m-mama programme were grouped into four key themes: community engagement, emergency transportation system, government engagement, and challenges and constraints in technical implementation. Stakeholder engagement and collaboration at all levels, community involvement in implementation, adherence to local contexts and effective government partnerships were identified as key drivers for programme success. Coordination, supervision and infrastructure enhancement were crucial in implementing the emergency transportation system.

Conclusions
Facilitating community involvement, understanding the local context and adapting to existing structures can enhance programme ownership and utilisation. The government serves as the central coordinator, overseeing resource mobilisation and distribution. A well-executed and coordinated emergency transportation system holds promise in addressing delays and curbing maternal and neonatal mortality. Collaborative knowledge-sharing among implementers is essential for identifying best practices and gaining insights into practical strategies for addressing anticipated challenges.

Leggi
Febbraio 2024

Protocol for a multicentre and prospective follow-up cohort study of early detection of atrial fibrillation, silent stroke and cognitive impairment in high-risk primary care patients: the PREFA-TE study

Background
Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Future estimations suggest an increase in global burden of AF greater than 60% by 2050. Numerous studies provide growing evidence that AF is not only associated with stroke but also with cognitive impairment and dementia.

Aim
The main goal is to assess the impact of the combined use of cardiac rhythm monitoring devices, echocardiography, biomarkers and neuroimaging on the early diagnosis of AF, silent strokes and cognitive decline, in subjects at high risk of AF.

Methods and analysis
Two-year follow-up of a cohort of individuals aged 65–85 years at high risk for AF, with no prior diagnosis of either stroke or dementia. The study involves baseline echocardiography, biomarkers, and neuroimaging, yearly cardiac monitoring, and semiannual clinical assessments. Different parameters from these tests will be analysed as independent variables. Throughout the study period, primary outcomes: new diagnoses of AF, stroke and cognitive impairment, along with any clinical and therapeutic changes, will be registered. A first descriptive and bivariate statistical analysis, appropriate to the types of variables, will be done. The information obtained from the data analysis will encompass adjusted risk estimates along with 95% confidence intervals. Event risk predictions will rely on multivariate Cox proportional hazards regression models. The predictive value of the model will be evaluated through the utilisation of receiver operating characteristic curves for area under the curve calculation. Additionally, time-to-event analysis will be performed using Kaplan-Meier curves.

Ethics and dissemination
This study protocol has been reviewed and approved by the Independent Ethics Committee of the Foundation University Institute for Primary Health Care Research-IDIAP Jordi Gol (expedient file 22/090-P). The authors plan to disseminate the study results to the general public through various scientific events. Publication in open-access journals and presentations at scientific congresses, seminars and meetings is also foreseen.

Trial registration number
NCT05772806.

Leggi
Febbraio 2024

Patient experiences with patient-led, home-based follow-up after curative treatment for colorectal cancer: a qualitative study

Objectives
The number of patients with colorectal cancer (CRC) in need of oncological follow-up is growing. As a response, patient-led, home-based follow-up (PHFU) was developed, implemented and assessed. The aim of this study was to investigate how patients experienced PHFU.

Design
A qualitative study with individual semistructured interviews. Interviews were transcribed verbatim, and thematically analysed through an inductive, double-coding approach.

Setting
A university medical centre in the Netherlands.

Participants
12 curatively treated patients with CRC who received PHFU were included after purposive sampling.

Results
Overall, participants (N=12) were satisfied with PHFU. The time and cost-saving aspects for patient and hospital were evidently valued. PHFU was experienced as a shared effort, but patients felt like the primary responsibility remained in the hospital. Patients mentioned a decreased personal interaction with their healthcare provider (HCP) and felt a higher threshold to ask for help. However, all major questions were still addressed. Patients felt sufficiently competent to interpret their individual test results but experienced difficulty in interpreting repeated increases in carcinoembryonic antigen levels within the normal range. Educational status, age and a complicated disease course were seen as factors limiting the applicability of PHFU, and it was expressed that PHFU should be offered as an alternative instead of a novel standard of care.

Conclusions
According to patients, PHFU has great potential. However, PHFU may not be suitable for every CRC patient, and factors such as educational status, age and disease course should be taken into consideration. Patient and HCP have a shared responsibility to help successfully organise PHFU in practice.

Leggi
Febbraio 2024

Kharameh cohort study (KHCS) on non-communicable diseases and preliminary findings of 3-year follow-up

Purpose
The Kharameh cohort study (KHCS) is one branch of the ‘Prospective Epidemiological Research Studies in Iran’, located in the south of Iran. The enrolment phase of KHCS spanned from April 2015 to March 2017, during which urban and rural residents of Kharameh were enrolled in the study. KHCS aims to investigate the incidence of non-communicable diseases (NCDs) such as hypertension, diabetes mellitus, cardiovascular diseases and cancer, and its related risk factors in a 15-year follow-up.

Participants
KHCS was designed to recruit 10 000 individuals aged 40–70 years old from both urban and rural areas of Kharameh. Thus, a total of 10 800 individuals aged 40–70 years of age were invited and, finally, 10 663 subjects were accepted to participate, with a participation rate of 98.7%.

Findings to date
Of the 10 663 participants, 5944 (55.7%) were women, and 6801 (63.7%) were rural residents. The mean age of the participants was 51.9±8.2 years. 41.8% of the participants were aged 40–49, 35.2% were aged 50–59 and the remaining 23% were 60–70 years old. Until March 2020 (first 3 years of follow-up), the total number of patients diagnosed with NCDs was 1565. Hypertension, type 2 diabetes and acute ischaemic heart disease were the most common NCDs. Furthermore, the total number of deaths during the first 3 years of follow-up was 312, with cardiovascular diseases (38.7%) as the most common cause of death, followed by cerebrovascular diseases (11.8%) and cancer (16.2%).

Future plans
The remaining 12 years of follow-up will inevitably shed light on the genetic, lifestyle/socioeconomic status, and environmental risk and protective factors of NCDs.

Leggi
Febbraio 2024

Sustained benefits of a generalist training programme for UK doctors: a survey-based follow-up study

Objectives
The study aimed to conduct a follow-up of all broad-based training (BBT) trainees who participated in the original evaluation completed in 2017. The follow-up study explored the impact of BBT on career decisions, sustained benefits and unintended disadvantages of the programme, and views on the future of training.

Design
Scoping interviews informed the design of an online survey. The interview transcripts were analysed thematically. The survey was piloted with six volunteers and sent out to all former BBT trainees. Data from the survey were transferred to Excel and SPSS for analysis. The open-text comments on the survey were subject to a thematic content analysis.

Setting
Participants were working in general practice, paediatrics, psychiatry or medicine.

Participants
Eight former BBT trainees participated in the scoping interviews. Interview participants were selected to ensure a diversity of current specialties and to represent all three BBT cohorts. All former BBT trainees were invited to complete the survey (n=118) and 70 replied.

Results
The benefits of BBT were sustained over time: participants were confident in their career decisions, took a holistic approach to care and capitalised on their experiences in other specialties in their current roles. A minority of trainees also experienced temporary challenges when they joined a specialty training programme after completing the BBT. Whatever their specialty, experience in core medicine, paediatrics, psychiatry and general practice was valued. Disadvantages were short-lived (catching up on transition specialty training) or affected a minority (impact on sense of belonging).

Conclusions
The BBT programme supported the development of generalist doctors. Greater attention needs to be given to training secondary care doctors who take a holistic view of the patient and navigate their specialist care.

Leggi
Febbraio 2024

VersKiK qualitative study design: actual follow-up needs of paediatric cancer survivors, their informal caregivers and follow-up stakeholder perceptions in Germany

Introduction
This article presents the study design of the qualitative part of the VersKiK study (Long-term care, care needs and wellbeing of individuals after cancer in childhood or adolescence: study protocol of a large scale multi-methods non-interventional study) aiming to explore actual follow-up needs of childhood and adolescence cancer survivors and their informal caregivers, gaps in current follow-up care provision and trajectories of cancer survivors’ transition from paediatric to adult healthcare.

Methods and analysis
We will conduct up to 30 interviews with survivors of childhood and adolescence cancer and their informal caregivers with up to 20 participant observations of follow-up appointments. The results of these will be discussed in up to four focus groups with healthcare professionals and representatives of self-help groups. The study design aims to evaluate follow-up care after childhood cancer considering perspectives from survivors, their informal caregivers as well as healthcare providers. The combination of different data sources will allow us to get an in-depth understanding of the current state of follow-up care after paediatric cancer in Germany and to suggest recommendations for care improvement.

Ethics and dissemination
The VersKiK study was approved by the Ethics Committee Otto von Guericke University on 2 July 2021 (103/21), by the Ethics Committee of Johannes Gutenberg University Mainz on 16 June 2021 (2021-16035), by the Ethics Committee University of Lübeck on 10 November 2021 (21-451), by the Ethics Committee University of Hospital Bonn on 28 February 2022 (05/22). For each part of the qualitative study, a separate written informed consent is prepared and approved accordingly by the ethics committees named above.

Trial registration number
Registered at German Clinical Trial Register, ID: DRKS00026092.

Leggi
Febbraio 2024

Clinical characteristics and outcomes of traumatic brain injury in patients admitted to surgical ward of Jimma Medical Center, Southwest Ethiopia: a prospective observational follow-up study

Objective
To assess the Clinical Characteristics and Outcomes of Traumatic Brain Injury in Patients Admitted to the Surgical Ward of Jimma Medical Center, Southwest Ethiopia from January to July 2022.

Design and setting
A hospital-based prospective observational study was conducted among 175 patients admitted with Traumatic Brain Injury at Jimma Medical Center from January to July 2022. Data were collected by structured questionnaires and a convenient sampling technique was used. For data entry, Epidata V.4.6.0.5 software was used and exported to Stata V.14.0.2 for analysis. The Cox regression model was fitted to evaluate the predictors of mortality and variables with a p value

Leggi
Febbraio 2024

Abstract TP92: Feasibility of a Poststroke Without-Fail Care Rate to Assess Rehabilitation and Follow-Up Care

Stroke, Volume 55, Issue Suppl_1, Page ATP92-ATP92, February 1, 2024. Introduction:Large cohort studies show substantial variability in poststroke care. We developed a guideline-based poststroke without-fail care rate (PWR) to measure rehabilitation and follow-up care quality (Table 1). Our primary aim was to test PWR feasibility to measure guideline-concordant poststroke care among individuals discharged from an urban safety net hospital. Secondarily, we evaluated socioeconomic strain’s (SES) relationship with PWR.Methods:We reviewed electronic medical records of individuals with acute ischemic stroke (AIS) admitted to an urban safety net hospital from July 1 – August 31, 2022. Individuals were given a pass/fail or ineligible for each process. The PWR, calculated per individual, was passes/total number of eligible processes (score 0-1.0).Results:Out of 30 persons with AIS, 20 were eligible for PWR assessment (Table 2). Mean PWR was 0.598 (SD .210, range .273-.900). Most processes were readily available, with no observable floor or ceiling effects. Lowest pass rates were seen in therapy continuance, PCP follow-up, blood pressure control, and exercise. The PWR difference between individuals with SES (M = .443, SD =.135) and without SES (M = .634, SD = .246) lacked statistical significance but demonstrated a high effect size; t(10) = 1.66, p = .064, d = .961.Conclusion:The PWR is a feasible tool to assess quality of poststroke care and may be useful to identify and evaluate interventions to improve equity and quality of poststroke care. The high effect size of SES warrants further examination in a larger sample.

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Febbraio 2024