Process evaluation of the scale-up of integrated diabetes and hypertension care in Belgium, Cambodia and Slovenia (the SCUBY Project): a study protocol

Introduction
Integrated care interventions for type 2 diabetes (T2D) and hypertension (HT) are effective, yet challenges exist with regard to their implementation and scale-up. The ‘SCale-Up diaBetes and hYpertension care’ (SCUBY) Project aims to facilitate the scale-up of integrated care for T2D and HT through the co-creation and implementation of contextualised scale-up roadmaps in Belgium, Cambodia and Slovenia. We hereby describe the plan for the process and scale-up evaluation of the SCUBY Project. The specific goals of the process and scale-up evaluation are to (1) analyse how, and to what extent, the roadmap has been implemented, (2) assess how the differing contexts can influence the implementation process of the scale-up strategies and (3) assess the progress of the scale-up.

Methods and analysis
A comprehensive framework was developed to include process and scale-up evaluation embedded in implementation science theory. Key implementation outcomes include acceptability, feasibility, relevance, adaptation, adoption and cost of roadmap activities. A diverse range of predominantly qualitative tools—including a policy dialogue reporting form, a stakeholder follow-up interview and survey, project diaries and policy mapping—were developed to assess how stakeholders perceive the scale-up implementation process and adaptations to the roadmap. The role of context is considered relevant, and barriers and facilitators to scale-up will be continuously assessed.

Ethics and dissemination
Ethical approval has been obtained from the Institutional Review Board (ref. 1323/19) at the Institute of Tropical Medicine (Antwerp, Belgium). The SCUBY Project presents a comprehensive framework to guide the process and scale-up evaluation of complex interventions in different health systems. We describe how implementation outcomes, mechanisms of impact and scale-up outcomes can be a basis to monitor adaptations through a co-creation process and to guide other scale-up interventions making use of knowledge translation and co-creation activities.

Leggi
Dicembre 2022

Individualised follow-up for head and neck cancer–design of a prospective cohort study to assess its feasibility

Introduction
It is a common practice for many cancer types to monitor patients after treatment to detect new disease manifestations early. For head and neck cancer (HNC), however, long-term routine follow-up is up for debate for several reasons. The benefits of prolonged routine follow-up on survival have not been proven. Also, cancer follow-up is putting increasing pressure on healthcare resources due to rising incidence and survival rates. Therefore, this study investigates a novel follow-up approach among HNC patients, giving them the opportunity to choose their own follow-up programme.

Methods and analysis
HNC patients are offered a decision-aided choice between standardised or individualised follow-up after 1.5 years of uncomplicated guideline-prescribed follow-up. Standardised follow-up entails continuing the 5-year guideline-prescribed schedule. Individualised follow-up means the patient only attends the outpatient clinic on their own initiative in case of physical symptoms or supportive care needs. Patients are educated on self-examination and when a control visit is necessary. The primary outcome measure is the feasibility of offering patients this choice. Secondary outcome measures are quality of life, costs, productivity loss and detection of new disease.

Ethics and dissemination
We believe that it is essential to let patients determine their follow-up programme based on their own values and preferences. If this choice is feasible, it can be implemented and investigated in other HNC care centres.

Trial registration number
NCT05386225.

Leggi
Dicembre 2022

Association between serum uric acid/HDL-cholesterol ratio and chronic kidney disease: a cross-sectional study based on a health check-up population

Objective
Evidence suggests that both serum uric acid (SUA) and high-density lipoprotein cholesterol (HDL-C) are risk factors for chronic kidney disease (CKD). The SUA-to-HDL-C ratio (UHR) has recently attracted attention as a new biomarker to evaluate the role between inflammatory and anti-inflammatory substances. Thus, we explored the association between UHR and CKD in a large Chinese population.

Design
A cross-sectional study.

Setting
Annual health check-up population in Nanjing.

Participants
19 458 individuals who underwent an annual health check-up in 2019 were included in our study.

Main outcome measure
CKD was diagnosed according to an estimated glomerular filtration rate (eGFR)

Leggi
Dicembre 2022

Sarcopenia and coexistent risk factors detected using the 'Yubi-wakka (finger-ring) test in adults aged over 65 years in the public annual health check-up in Tama City, Tokyo: a cross-sectional study

Objectives
To examine the positive rate of sarcopenia using the ‘Yubi-wakka’ (finger-ring) test and associated risk factors among adults aged 65 years and older.

Design
Cross-sectional study.

Setting
We used the Yubi-wakka test, which has been developed and validated as a predictor of sarcopenia, frailty, disability and mortality. A positive test result is indicated by a smaller calf circumference than the finger-ring. The test was administered during annual health check-ups among residents of Tama City, Japan.

Participants
During the 2019 fiscal year, 12 894 individuals aged 65 years and older underwent the Yubi-wakka test at primary care clinics.

Interventions
Examinees conducted the test themselves in a seated position. They formed a ring around their calf using both thumbs and index fingers and judged whether their calf was larger, the same or smaller than their finger-ring.

Primary and secondary outcome measures
We compared anthropometric and serological data between the positive (smaller calf) and negative (larger calf) test result groups.

Results
The positive rate was 15.4% among men and 18.5% among women. The prevalence of a positive result was higher in those aged ≥80 years than in younger age groups in both sexes (men: 22.8%; women: 28.8%). Multivariate logistic regression analysis showed that a diagnosis of metabolic syndrome was a risk factor for detecting a positive test result in women aged 65–74 years (OR 3.445; 95% CI 1.44 to 8.29) and ≥75 years (OR 3.37; 95% CI 1.97 to 5.78).

Conclusions
Because the Japanese population is healthy and lives long, interventions against sarcopenia are important, especially for older adults aged >75 years. The presence of metabolic syndrome may be a risk factor for sarcopenia (as detected by the Yubi-wakka test) and future frailty, and requires closer attention, especially among women.

Leggi
Dicembre 2022

Predictors of first-line antiretroviral treatment failure among children on antiretroviral therapy at the University of Gondar comprehensive specialised hospital, North-west, Ethiopia: a 14-year long-term follow-up study

Objective
To determine the incidence and predictors of first-line human immune deficiency virus treatment failure among human immune deficiency virus-infected children at the University of Gondar comprehensive specialised hospital in Ethiopia.

Design
A retrospective follow-up study.

Setting
University of Gondar comprehensive specialised hospital, North-west, Ethiopia.

Participants
Children were among the HIV infected from January 2005 to December 2018. There were 336 children included in the study. The data were entered into EPi Info V.7.2 and then exported to STATA V.14.0 Software for analysis. Both bivariable and multivariable analyses with Cox proportional hazards models were used to identify the predictors of treatment failure.

Primary outcome measures
Predictors of first-line antiretroviral treatment failure among children on antiretroviral therapy (ART) during 14 years long-term follow-up study.

Result
A total of 336 human immunodeficiency virus-infected children participated in this study with 27 058 child years of observation. The overall incidence rate was 2.1 (95% CI 1.57 to 2.78) per 100 child years. Poor adherence (adjusted HR (AHR); 6.5 (95% CI 2.03 to 21.39)), fair adherence (AHR; 6.55 (95% CI 2.64 to 16.53), the presence of opportunistic infection (AHR; 4.22 (95% CI 1.44 to 12.30), clinical staging of III/IV (AHR; 3.08 (95% CI 1.17 to 8.08) and a baseline CD4 count less than 200 cells/mm3 (AHR; 3.61 (95% CI 1.12 to 11.54)).

Conclusion
The incidence of first-line ART failure was found to be high. Baseline opportunistic infection, poor and fair adherence, advanced WHO clinical staging III/IV and a CD4 count less than 200 cells/mm3 were all predictors of first-line treatment failure. Early identification of associated factors and monitoring treatment failure has to be important for the optimal management of HIV-infected children who are receiving ART and to prevent further complications.

Leggi
Dicembre 2022

Additional operation rates after surgery for degenerative spine diseases: minimum 10 years follow-up of 4705 patients in the national Swedish spine register

Objectives
To identify rates of additional operation after the index operation for degenerative lumbar spine diseases.

Design
Retrospective register study.

Setting
National outcome data from Swespine, the National Swedish spine register.

Participants
A total of 4705 patients who underwent one-level surgery for degenerative disk disease (DDD) or lumbar spinal stenosis (LSS) with or without degenerative spondylolisthesis (DS) between 1 January 2007 and 31 December 2010 were followed from 1 January 2007 to 31 December 2020 to record all cases of additional lumbar spine operations.

Interventions
One-level spinal decompression and/or posterolateral fusion for degenerative spine diseases.

Primary outcome measures
Number of additional operations.

Results
Additional operations were more common at adjacent levels for patients with LSS with DS treated with decompression and fusion whereas additional operations were more evenly distributed between the index level and the adjacent levels for DDD treated with fusion and LSS with and without DS treated with decompression only. For patients younger than 60 years, treated with decompression and fusion for LSS with DS, the additional operations were evenly distributed between the index level and the adjacent levels.

Conclusions
There are different patterns of additional operations following the index procedure after surgery for degenerative spine diseases. Rigidity across previously mobile segments is not the only important factor in the development of adjacent segment disease (ASD) after spinal fusion, also the underlying disease and age may play parts in ASD development. The findings of this study can be used in the shared decision-making process when surgery is a treatment option for patients with degenerative lumbar spine diseases as the first operation may be the start of a series of additional spinal operations for other degenerative spinal conditions, either at the index level or at other spinal levels.

Leggi
Dicembre 2022

Escalating the limit of median survival time and predictors of mortality among preterm neonates in Northwest Ethiopia, 2021: a 1-year prospective follow-up study

Objectives
To examine the survival rate and predictors of mortality among preterm neonates in the neonatal intensive care unit at South Gondar public hospitals, 2021.

Design
Prospective follow-up study.

Setting
South Gondar public hospitals, Northwest, Ethiopia.

Participants
We recruited 283 preterm neonates who were admitted at neonatal intensive care unit at selected hospitals from 15 February 2020 to 22 January 2021.

Outcome measures
The primary outcome measure of this study was the survival rate of preterm neonates in the neonatal intensive care unit. Moreover, the study assessed the predictors for the occurrence of mortality by the Cox-proportional hazard model. Data were entered into Epi data V.4.2 and exported to Stata V.14 statistical software for analysis. The log-rank test determines the survival difference between predictor variables.

Results
A total of 283 preterm neonates, 61 died during the follow-up. Born from antepartum haemorrhage mother (adjusted HR (AHR)=2.2 (95% CI 1.10 to 4.37)), being small weight for gestational age (AHR=4.6 (95% CI 2.22 to 9.53)), not having kangaroo mother care practice initiated (AHR=2.7 (95% CI 1.39 to 7.74)), hypothermia (AHR=4.0 (95% CI 1.96 to 8.30)) and perinatal asphyxia (AHR=3.9 (95% CI 1.97 to 7.94)) were significant predictors of preterm neonate mortality.

Conclusion
In this study, the preterm neonates survival rate (78.4%) and the median survival time (21 days) were found to be low. Preventing and managing the predictors, including an antepartum haemorrhagic mother, small weight for gestational age, hypothermia and prenatal asphyxia, is crucial. In addition, more emphasis should be placed on initiating universal kangaroo mother care practice soon after birth to increase the survival of preterm neonates.

Leggi
Dicembre 2022

Prevalence, pathophysiology, prediction and health-related quality of life of long COVID: study protocol of the longitudinal multiple cohort CORona Follow Up (CORFU) study

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.

Leggi
Novembre 2022

Antepartum and labour-related single predictors of non-participation, dropout and lost to follow up in a randomised controlled trial comparing internet-based cognitive-behaviour therapy with treatment as usual for women with negative birth experiences and/or post-traumatic stress following childbirth

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

Leggi
Novembre 2022

Five-year follow-up of patients with knee osteoarthritis not eligible for total knee replacement: results from a randomised trial

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.

Leggi
Novembre 2022

Torn between two worlds: parental experiences of neonatal follow-up for infants with hypoxic ischaemic encephalopathy in India-a qualitative study using interpretative phenomenological analysis

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.

Leggi
Novembre 2022