Comparing exercise and patient education with usual care in the treatment of hip dysplasia: a protocol for a randomised controlled trial with 6-month follow-up (MovetheHip trial)

Introduction
Surgery is not a viable treatment for all patients with hip dysplasia. Currently, usual care for these patients is limited to a consultation on self-management. We have shown that an exercise and patient education intervention is a feasible and acceptable intervention for patients not receiving surgery. Therefore, we aim to investigate whether patients with hip dysplasia randomised to exercise and patient education have a different mean change in self-reported pain compared with those randomised to usual care over 6 months. Furthermore, we aim to evaluate the cost-effectiveness and perform a process evaluation.

Methods and analysis
In a randomised controlled trial, 200 young and middle-aged patients will be randomised to either exercise and patient education or usual care at a 1:1 ratio through permuted block randomisation. The intervention group will receive exercise instruction and patient education over 6 months. The usual care group will receive one consultation on self-management of hip symptoms. The primary outcome is the self-reported mean change in the pain subscale of the Copenhagen Hip and Groin Outcome Score (HAGOS). Secondary outcomes include mean changes in the other HAGOS subscales, in the Short Version of the International Hip Outcome Tool, in performance, balance and maximal hip muscle strength. Between-group comparison from baseline to 6-month follow-up will be made with intention-to-treat analyses with a mixed-effects model. Cost-effectiveness will be evaluated by relating quality-adjusted life years and differences in HAGOS pain to differences in costs over 12 months. The functioning of the intervention will be evaluated as implementation, mechanisms of change and contextual factors.

Ethics and dissemination
The study protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region and registered at ClinicalTrials. Positive, negative and inconclusive findings will be disseminated through international peer-reviewed scientific journals and international conferences.

Trial registration number
NCT04795843.

Leggi
Settembre 2022

Prevalence, incidence and longevity of antibodies against SARS-CoV-2 among primary healthcare providers in Belgium: a prospective cohort study with 12 months of follow-up

Objectives
To estimate the prevalence, incidence and longevity of antibodies against SARS-CoV-2 among primary healthcare providers (PHCPs).

Design
Prospective cohort study with 12 months of follow-up.

Setting
Primary care in Belgium.

Participants
Any general practitioner (GP) working in primary care in Belgium and any other PHCP from the same GP practice who physically manages (examines, tests, treats) patients were eligible. A convenience sample of 3648 eligible PHCPs from 2001 GP practices registered for this study (3044 and 604 to start in December 2020 and January 2021, respectively). 3390 PHCPs (92,9%) participated in their first testing time point (2820 and 565, respectively) and 2557 PHCPs (70,1%) in the last testing time point (December 2021).

Interventions
Participants were asked to perform a rapid serological test targeting IgM and IgG against the receptor binding domain of SARS-CoV-2 and to complete an online questionnaire at each of maximum eight testing time points.

Primary and secondary outcome measures
The prevalence, incidence and longevity of antibodies against SARS-CoV-2 both after natural infection and after vaccination.

Results
Among all participants, 67% were women and 77% GPs. Median age was 43 years. The seroprevalence in December 2020 (before vaccination availability) was 15.1% (95% CI 13.5% to 16.6%), increased to 84.2% (95% CI 82.9% to 85.5%) in March 2021 (after vaccination availability) and reached 93.9% (95% CI 92.9% to 94.9%) in December 2021 (during booster vaccination availability and fourth (delta variant dominant) COVID-19 wave). Among not (yet) vaccinated participants the first monthly incidence of antibodies against SARS-CoV-2 was estimated to be 2.91% (95% CI 1.80% to 4.01%). The longevity of antibodies is higher in PHCPs with self-reported COVID-19 infection.

Conclusions
This study confirms that occupational health measures provided sufficient protection when managing patients. High uptake of vaccination resulted in high seroprevalence of SARS-CoV-2 antibodies in PHCPs in Belgium. Longevity of antibodies was supported by booster vaccination and virus circulation.

Trial registration number
NCT04779424.

Leggi
Settembre 2022

Determining the Endoscopic Follow-Up for Gastric Ulcers Based Upon Endoscopic Appearance and Histology (Poster Presentation)

Gastric ulcers are common, but the prevalence rate of malignancy in endoscopically diagnosed gastric ulcers varies considerably. It is unclear whether endoscopic follow-up is warranted in all patients with gastric ulcers, as the yield of the follow-up endoscopy is very low, especially in the setting when histology shows benign features. We performed a quality improvement project to determine the diagnostic accuracy of combined endoscopic and histologic features in differentiating benign from malignant gastric ulcers vs endoscopic features only and to avoid over-use of endoscopic evaluation of ulcer healing for benign cases.

Leggi
Settembre 2022

Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Artery Disease: Extended Follow-up Outcomes of Multicenter Randomized Controlled BEST Trial

Circulation, Ahead of Print. Background: Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stent and coronary-artery bypass grafting (CABG) are limited in patients with multivessel coronary artery disease.Methods: This prospective, multicenter, randomized, controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stent or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early due to slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target-vessel revascularization.Results: During a median follow-up of 11.8 years (interquartile range, 10.6 to 12.5 years, maximum 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio [HR] 1.18; 95% confidence interval [CI], 0.88 to 1.56; P=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%, HR 1.07; 95% CI 0.75 to 1.53; P=0.70) as well as the occurrence of death from any cause (20.5% and 19.9%, HR 1.04; 95% CI 0.65 to 1.67; P=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%, HR 1.86; 95% CI 1.06 to 3.27; P=0.031) and any repeat revascularization (22.6% and 12.7%, HR 1.92; 95% CI 1.58 to 2.32; P

Leggi
Settembre 2022

Short-term outcomes and intermediate-term follow-up of Helicobacter pylori infection treatment for naïve patients: a retrospective observational study

Objectives
To explore the outcomes of Helicobacter pylori infection treatments for naïve patients in the real-world settings.

Design
A retrospective observational study.

Setting
Single tertiary level academic hospital in China.

Participants
We identified patients initially receiving quadruple therapy for H. pylori infection from 2017 to 2020 in whom eradication was confirmed (n=23 470).

Primary outcome
Efficacy of different initial H. pylori infection treatments.

Secondary outcome
Results of urea breath test (UBT) after H. pylori eradication.

Results
Among 23 470 patients who received initial H. pylori treatment, 21 285 (90.7%) were treated with amoxicillin-based regimens. The median age of the patients decreased from 2017 to 2020 (45.0 vs 39.0, p

Leggi
Settembre 2022

Intracapsular tonsillectomy in the treatment of recurrent and chronic tonsillitis in adults: a protocol of a prospective, single-blinded, randomised study with a 5-year follow-up (the FINITE trial)

Introduction
The standard surgical treatment for recurrent or chronic tonsillitis is extracapsular tonsillectomy. Recent studies show that intracapsular tonsillectomy has the potential to reduce the postoperative morbidity of patients undergoing tonsil surgery. The Finnish Intracapsular Tonsillectomy (FINITE) trial aims to provide level I evidence to support the hypothesis that the recovery time from tonsil surgery can be reduced with intracapsular tonsillectomy. Additionally, from this trial, major benefits in quality of life, reduction of postoperative complications, treatment costs and throat symptoms might be gained.

Methods and analysis
The FINITE trial is a prospective, randomised, controlled, patient-blinded, three-arm clinical trial. It is designed to compare three different surgical methods being extracapsular monopolar tonsillectomy versus intracapsular microdebrider tonsillectomy versus intracapsular coblation tonsillectomy in the treatment of adult patients (16–65 years) suffering from recurrent or chronic tonsillitis. The study started in September 2019, and patients will be enrolled until a maximum of 200 patients are randomised. Currently, we are in the middle of the study with 125 patients enrolled as of 28 February 2022 and data collection is scheduled to be completed totally by December 2027. The primary endpoint of the study will be the recovery time from surgery. Secondary endpoints will be the postoperative pain scores and the use of analgesics during the first 3 weeks of recovery, postoperative haemorrhage, quality of life, tonsillar remnants, need for revision surgery, throat symptoms, treatment costs and sick leave. A follow-up by a questionnaire at 1–21 days and at 1, 6, 24 and 60 months will be conducted with a follow-up visit at the 6-month time point.

Ethics and dissemination
Ethical approval was obtained from the Medical Ethics Committee of the Hospital District of Southwest Finland (reference number 29/1801/2019). Results will be made publicly available in peer-reviewed scientific journals.

Trial registration number
NCT03654742.

Leggi
Settembre 2022

Diagnostic work-up of urinary tract infections in pregnancy: study protocol of a prospective cohort study

Introduction
Symptoms of urinary tract infections in pregnant women are often less specific, in contrast to non-pregnant women where typical clinical symptoms of a urinary tract infection are sufficient to diagnose urinary tract infections. Moreover, symptoms of a urinary tract infection can mimic pregnancy-related symptoms, or symptoms of a threatened preterm birth, such as contractions. In order to diagnose or rule out a urinary tract infection, additional diagnostic testing is required.
The diagnostic accuracy of urine dipstick analysis and urine sediment in the diagnosis of urinary tract infections in pregnant women has not been ascertained nor validated.

Methods and analysis
In this single-centre prospective cohort study, pregnant women (≥16 years old) with a suspected urinary tract infection will be included. The women will be asked to complete a short questionnaire regarding complaints, risk factors for urinary tract infections and baseline characteristics. Their urine will be tested with a urine dipstick, urine sediment and urine culture. The different sensitivities and specificities per test will be assessed. Our aim is to evaluate and compare the diagnostic accuracy of urine dipstick analysis and urine sediment in comparison with urine culture (reference test) in pregnant women. In addition, we will compare these tests to a predefined ‘true urinary tract infection’, to distinguish between a urinary tract infection and asymptomatic bacteriuria.

Ethics and dissemination
Approval was requested from the Medical Ethics Review Committee of the Academic Medical Centre; an official approval of this study by the committee was not required. The outcomes of this study will be published in a peer-reviewed journal.

Leggi
Settembre 2022

Estimating deaths averted and cost per life saved by scaling up mRNA COVID-19 vaccination in low-income and lower-middle-income countries in the COVID-19 Omicron variant era: a modelling study

Objectives
While almost 60% of the world has received at least one dose of COVID-19 vaccine, the global distribution of vaccination has not been equitable. Only 4% of the population of low-income countries (LICs) has received a full primary vaccine series, compared with over 70% of the population of high-income nations.

Design
We used economic and epidemiological models, parameterised with public data on global vaccination and COVID-19 deaths, to estimate the potential benefits of scaling up vaccination programmes in LICs and lower-middle-income countries (LMICs) in 2022 in the context of global spread of the Omicron variant of SARS-CoV2.

Setting
Low-income and lower-middle-income nations.

Main outcome measures
Outcomes were expressed as number of avertable deaths through vaccination, costs of scale-up and cost per death averted. We conducted sensitivity analyses over a wide range of parameter estimates to account for uncertainty around key inputs.

Findings
Globally, universal vaccination in LIC/LMIC with three doses of an mRNA vaccine would result in an estimated 1.5 million COVID-19 deaths averted with a total estimated cost of US$61 billion and an estimated cost-per-COVID-19 death averted of US$40 800 (sensitivity analysis range: US$7400–US$81 500). Lower estimated infection fatality ratios, higher cost-per-dose and lower vaccine effectiveness or uptake lead to higher cost-per-death averted estimates in the analysis.

Conclusions
Scaling up COVID-19 global vaccination would avert millions of COVID-19 deaths and represents a reasonable investment in the context of the value of a statistical life. Given the magnitude of expected mortality facing LIC/LMIC without vaccination, this effort should be an urgent priority.

Leggi
Settembre 2022

Scoping review of the literature to ascertain how follow-up care is provided to major trauma patients post discharge from acute care

Objectives
Survival following traumatic injury has increased, requiring ongoing patient follow-up. While longitudinal outcomes of trauma patients are reported, little is known about optimal delivery of follow-up service for this group. The aim of this scoping review was to identify and describe the structure, process and outcomes of postdischarge follow-up services for patients who sustained major trauma.

Evidence review
This scoping review was conducted by searching CINAHL, MEDLINE and EMBASE databases. Articles were screened by three independent reviewers. The data of selected articles were organised in the categories of the Donabedian quality framework: structure, processes and outcomes.

Results
Twenty-six articles were included after screening by title/abstract then full text against the inclusion/exclusion criteria; 92% (n=24) were from the USA.
Follow-up services were provided by designated trauma centres and delivered by a mixture of health disciplines. Delivery of follow-up was multimodal (in person/telehealth). Protocols and guidelines helped to deliver follow-up care for non-physician led services.
Ongoing health issues including missed injuries, pain and infection were identified. No standardised criteria were established to determine recipients, the timing or frequency of follow-up was identified. Patients who engaged with follow-up services were more likely to participate in other health services. Patients reported satisfaction with follow-up care.

Conclusion
There are wide variations in how follow-up services for major trauma patients are provided. Further evaluation should focus on patient, family and organisational outcomes. Identifying who is most likely to benefit, when and how follow-up care is delivered are important next steps in improving outcomes.

Leggi
Settembre 2022

Cost-effectiveness of follow-up invasive coronary angiography after percutaneous coronary stenting: a real-world observational cohort study in Japan

Objectives
Follow-up invasive coronary angiography (FUICA) after percutaneous coronary intervention (PCI) has been shown to increase the rate of early coronary revascularisation without reducing the incidence of subsequent myocardial infarction or death. However, no studies have evaluated the cost-effectiveness of FUICA in patients after coronary stenting. Therefore, this study aimed to evaluate the cost-effectiveness of FUICA after PCI.

Design
Retrospective observational cohort study.

Setting
497 hospitals.

Participants and interventions
Overall, 558 patients who underwent coronary artery stenting between April 2014 and March 2015 were matched and included in the invasive angiographic follow-up (AF) group (n=279), in which patients underwent FUICA 6–12 months after PCI, or in the clinical follow-up alone group (CF; n=279) using propensity scores.

Primary and secondary outcome measures
The primary endpoint was the composite outcome of death, myocardial infarction, urgent coronary revascularisation, stroke or hospitalisation for the heart failure. The secondary endpoints included all-cause death, non-fatal myocardial infarction, urgent revascularisation, coronary artery bypass grafting, stroke, hospitalisation for the heart failure and any coronary revascularisation after a minimum of 6 months of follow-up.

Results
Costs were calculated as direct medical expenses based on medical fee billing information. The cumulative 3-year incidence of the primary endpoint was 5.3% in the AF group and 4.7% in the CF group (HR 1.02; 95% CI 0.47 to 2.20; p=0.98). The total incremental cost at the 3-year endpoint in the AF group was US$1874 higher than that in the CF group (US$8947±US$5684 vs US$7073±US$6360; p≤0.001).

Conclusions
FUICA increased the costs but did not improve clinical benefits. Thus, FUICA is not economically more attractive than CF alone.

Trial registration number
UMIN000039768.

Leggi
Agosto 2022

Factors influencing the translation of shared cancer follow-up care into clinical practice: a systematic review

Background
The increasing incidence of cancer, coupled with improved survivorship, has increased demand for cancer follow-up care and the need to find alternative models of care. Shared cancer follow-up care in general practice is a safe option in terms of quality of life and cancer recurrence; however, there are barriers to translating this into practice. This review aimed to identify factors that influence the translation of shared cancer follow-up care into clinical practice.

Methods
Systematic review. Seven electronic databases: MEDLINE, Science Citation Index, Academic Search Complete, CINAHL, APA Psychinfo, Health Source: Nursing/Academic Edition and Psychology and Behavioural Sciences Collection, were searched for published papers between January 1999 and December 2021. The narrative review included papers if they were available in full-text, English, peer-reviewed and focused on shared cancer follow-up care.

Results
Thirty-eight papers were included in the final review. Five main themes emerged: (1) reciprocal clinical information sharing is needed between oncologists and general practitioners, and needs to be timely and relevant; (2) responsibility of care should be shared with the oncologist overseeing care; (3) general practitioners skills and knowledge to provide cancer follow-up care; (4) need for clinical management guidelines and rapid referral to support general practitioners to provide shared follow-up care and (5) continuity of care and satisfaction of care is vital for shared care.

Conclusion
The acceptability of shared cancer follow-up care is increasing. Several barriers still exist to translating this into practice. Work is required to develop a shared-care model that can support general practitioners, while the oncologist can oversee the care and implement two-way communication between general and oncologists’ clinics. The move towards integrating electronic healthcare records and web-based platforms for information exchange provides a promise to the timely exchange of information.

PROSPERO registration number
CRD42020191538.

Leggi
Agosto 2022

Pessary or progesterone to prevent preterm birth in women with short cervical length: protocol of the 4-6 year follow-up of a randomised controlled trial (Quadruple-P)

Introduction
Vaginal progesterone and a cervical pessary are both interventions that are investigated for the prevention of preterm birth (PTB). Thus far, beneficial or harmful effects of these interventions on long-term child health and development are described, but evidence is not robust enough to draw firm conclusions. With this follow-up study, we intent to investigate if progesterone or a pessary is superior for the prevention of PTB considering the child’s health at 4–6 years of corrected age.

Methods and analysis
This study is a follow-up study of the Quadruple-P trial; a multicentre, randomised clinical trial (NL42926.018.13, Eudractnumber 2013-002884-24) which randomises women with an asymptomatic midtrimester short cervix to daily progesterone or a pessary for the prevention of PTB. All children born to mothers who participated in the Quadruple-P study (n=628 singletons and n=332 multiples) will be eligible for follow-up at 4–6 years of corrected age. Children will be assessed using parental questionnaires. Main outcomes are child (neuro)development and behaviour. Other outcomes include child mortality, growth and general health. A composite of adverse child outcomes will be compared between the progesterone and pessary groups reporting OR and the corresponding 95% CI. Analyses will be performed separately for singletons and multiples and using the intention-to-treat approach.

Ethics and dissemination
The Medical Research Ethics Committee from Amsterdam UMC confirmed that de Medical Research Involving Human Subjects Act (WMO) did not apply to our study (W20_481 #20.531). Results will be published in a peer-reviewed journal and shared with stakeholders and participants. This protocol is published before analysis of the results.

Trial registration number
Dutch Trial Register (NL9646).

Leggi
Agosto 2022

Changes in life satisfaction, depression, general health and sleep quality of Spanish older women during COVID-19 lockdown and their relationship with lifestyle: an observational follow-up study

Objetives
To analyse the effects of COVID-19 lockdown on mental well-being variables of older women, and to determine the influence of lifestyle and age on such effects. The hypothesis of the study was that all parameters related to mental well-being would worsen in older women during the COVID-19 lockdown.

Design
Observational follow-up study. Pre lockdown measurements were taken before the lockdown. Post lockdown measurements were taken as soon as began the de-escalation.

Setting
Senior centres in the Region of Murcia (Spain).

Participants
The sample was composed of 40 older women volunteers, over 54 years of age (mean age=62.35±8.15 years).

Primary and secondary outcome measures
Pre lockdown and post lockdown evaluations were carried out face to face. The following questionnaires were completed: Satisfaction with Life Scale, The Center for Epidemiologic Studies Depression Scale, The Short Form 36 Health Survey, The Pittsburgh Sleep Quality Index, the Global Physical Activity Questionnaire and Prevention with Mediterranean Diet.

Results
Post lockdown, a worsening was found in the variables of life satisfaction (p=0.001); depression (p

Leggi
Agosto 2022

Which factors play a role in the decision of mothers to participate in child follow-up examinations after participation in an RCT?: a semi-quantitative study

Objectives
To determine which factors contribute to the decision of mothers to participate with their child in follow-up (FU) examinations after participation in a randomised controlled trial (RCT) prior to conception.

Design
A cross-sectional survey, including Likert-scale items. Comparisons will be made between respondents who participated in all FU rounds of data collection and those who did not participate in any FU round with their child.

Participants
Women who participated in an RCT investigating the effect of a preconception lifestyle intervention (LIFEstyle study: Netherlands Trial Register: NTR1530) were invited to participate with their child in three FU data collections when the child had a mean age of 4.2 years, 4.6 years and 6.5 years, respectively. FU rounds included a health questionnaire, physical examination and cardiac assessment, successively.

Results
Sixty-seven respondents were included, of whom 7 (10%) did not participate in any FU round and 24 (36%) participated in all FU rounds. Women who participated with their child in all 3 FU data collection rounds felt more involved in the FU research (95.8%) and agreed more often that the FU was introduced well (91.7%) as compared with women that did not participate in any FU data collection round with their child (14.3% and 28.6%, respectively). Participants of FU rounds more often agreed that participation felt like a health check for their child as compared with non-participants. In addition, participants of the physical examination and cardiac assessment more often let their decision to participate depend fully on their child, as compared with non-participants (39.4% vs 17.7% and 52.5% vs 24%, respectively).

Conclusions
To increase participation rates in future FU studies of children after maternal participation in an RCT, we suggest to involve women in the design of the FU study, to emphasise possible perceived benefits of participation and to encourage women to actively involve their child in the decision of participation.

Leggi
Agosto 2022