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Experiences of living with overweight/obesity and early type 2 diabetes in Singapore--a qualitative interview study

Por: Lee · M. · Khoo · H. S. · Krishnasamy · C. · Loo · M. E. · Wong · S. K. W. · Cheng · S. C. · Bei · E. · Tan · S. Y. · Xie · P. · Lee · E. S. · Tang · W. E.
Objectives

To understand the lived experience of adults with overweight/obesity and early type 2 diabetes in a modern urban environment, and the interrelations among the various aspects of these experiences and participants’ attitudes to weight management.

Design

Qualitative inductive approach to analysing data thematically from semistructured interviews and interpreted from a socioecological perspective.

Setting

Primary care clinics located in northern and central Singapore.

Participants

21 patients between 29 and 59 years old who are living with overweight/obese (Body Mass Index of 25.3–44.0kg/m2) and type 2 diabetes for 6 years or less.

Results

The main themes everyday life, people around me and within me pointed to a combination of barriers to weight and health management for participants. These included environmental factors such as easy physical and digital access to unhealthy food, and high-stress work environments; social factors such as ambiguous family support and dietary practices of peers; and individual factors such as challenges with self-regulation, prioritising work, dealing with co-existing medical conditions and the emotional significance of food. While lack of motivation and cultural dietary practices are hard to change, a problem-solving attitude, and presence of role models, may enable behaviour change.

Conclusion

An exploration of the lifeworld of patients with overweight/obese and early type 2 diabetes revealed that work demands, dietary practices in the workplace and at home, and the easy availability of calorie-dense foods afforded by a technology-infused environment hindered the individual’s efforts at maintaining a healthy weight and lifestyle. Policy and initiatives promoting work-life balance as well as individualised interventions can support participants’ stress management, and problem-solving capability for behaviour change. These barriers stemmed from the various domains of the environmental, interpersonal and intrapersonal but were interrelated. They underscored the need for an integrated approach to weight and diabetes management.

Risk equations for prosthetic joint infections (PJIs) in UK: a retrospective study using the Clinical Practice Research Datalink (CPRD) AURUM and GOLD databases

Por: Perni · S. · Prokopovich · P.
Background

Prosthetic joint infections (PJIs) are a serious negative outcome of arthroplasty with incidence of about 1%. Risk of PJI could depend on local treatment policies and guidelines; no UK-specific risk scoring is currently available.

Objective

To determine a risk quantification model for the development of PJI using electronic health records.

Design

Records in Clinical Practice Research Datalink (CPRD) GOLD and AURUM of patients undergoing hip or knee arthroplasty between January 2007 and December 2014, with linkage to Hospital Episode Statistics and Office of National Statistics, were obtained. Cohorts’ characteristics and risk equations through parametric models were developed and compared between the two databases. Pooled cohort risk equations were determined for the UK population and simplified through stepwise selection.

Results

After applying the inclusion/exclusion criteria, 174 905 joints (1021 developed PJI) were identified in CPRD AURUM and 48 419 joints (228 developed PJI) in CPRD GOLD. Patients undergoing hip or knee arthroplasty in both databases exhibited different sociodemographic characteristics and medical/drug history. However, the quantification of the impact of such covariates (coefficients of parametric models fitted to the survival curves) on the risk of PJI between the two cohorts was not statistically significant. The log-normal model fitted to the pooled cohorts after stepwise selection had a C-statistic >0.7.

Conclusions

The risk prediction tool developed here could help prevent PJI through identifying modifiable risk factors pre-surgery and identifying the patients most likely to benefit from close monitoring/preventive actions. As derived from the UK population, such tool will help the National Health Service reduce the impact of PJI on its resources and patient lives.

Where does physical activity fit into preschool postpandemic? A qualitative exploration with parents, teachers and administrators

Por: Zulauf-McCurdy · C. · Tessema · B. · Tang · R. · Almeida · S. · Tandon · P. S.
Objectives

During the preschool years, children depend on adult caregivers to provide opportunities for physical activity (PA). Research has focused on measuring PA in preschool, as well as barriers and facilitators to children’s PA but caregiver perceptions remain largely unknown especially in light of the COVID-19 pandemic. This study aims to understand the value of PA in preschool following the pandemic from three types of adult caregivers, parents of a young child (n=7), preschool teachers (n=7) and preschool administrators (n=7).

Methods

In-depth qualitative interviews were conducted to explore the following research questions: (a) how do caregivers describe the importance of PA in preschool postpandemic? (b) how do caregivers support and prioritise PA in preschool postpandemic and what challenges do they face in doing so? and (c) how do caregivers interact with one another to promote PA? Qualitative answers were coded using a codebook developed to answer the research questions of interest.

Results

Parents, teachers and administrators all described valuing PA for preschoolers, but each caregiver type described a different way of promoting it. All the caregivers listed barriers that inhibit their ability to prioritise and promote PA, some heightened postpandemic. Lastly, there were limited caregiver interactions when it came to promoting PA, with the burden largely falling on teachers.

Conclusion

Our findings indicate that one particularly important area for intervention is supporting parents, teachers and preschool administrators in creating a shared understanding of the importance of PA for young children and ways to collaborate to promote it.

Frontline health workers experiences of providing care for people living with non-communicable diseases during the COVID-19 pandemic in Ghana: a qualitative study

Por: Baatiema · L. · de-Graft Aikins · A. · Koram · K. K. · Kunfah · S. M. P. · Allen · L. N. · Abimbola · S. · Kruk · M.
Background

The COVID-19 pandemic has significantly impacted frontline health workers. However, a neglected dimension of this discourse was the extent to which the pandemic impacted frontline healthcare workers providing non-communicable diseases (NCDs) care. This study aims to understand the experiences of healthcare workers with no prior exposure to pandemics who provided care to people living with NCDs (PLWNCDs).

Methods

A qualitative study design was employed, using a face-to-face in-depth interviews. Interviews were conducted in primary healthcare facilities in three administrative regions of Ghana, representing the Northern, Southern and Middle Belts. Only frontline health workers with roles in providing care for PLWNCDs were included. Purposive snowballing and convenience sampling methods were employed to select frontline health workers. An open-ended interview guide was used to facilitate data collection, and thematic content analysis was used to analyse the data.

Results

A total of 47 frontline health workers were interviewed. Overall, these workers experienced diverse patient-driven and organisational challenges. Patient-level challenges included a decline in healthcare utilisation, non-adherence to treatment, a lack of continuity, fear and stigma. At the organisational levels, there was a lack of medical logistics, increased infection of workers and absenteeism, increased workload and burnout, limited motivational packages and inadequate guidelines and protocols. Workers coped and responded to the pandemic by postponing reviews and consultations, reducing inpatient and outpatient visits, changing their prescription practices, using teleconsultation and moving to long-shift systems.

Conclusion

This study has brought to the fore the experiences that adversely affected frontline health workers and, in many ways, affected the care provided to PLWNCDs. Policymakers and health managers should take these experiences into account in plans to mitigate the impact of future pandemics.

Risk of transmission of HIV to infants during breast/chest feeding when mothers/birthing parents living with HIV are on antiretroviral therapy: a protocol for a rapid review

Por: Djiadeu · P. · Begum · H. · Archibald · C. · Ekmekjian · T. · Busa · G. · Dansoh · J. · Van Nguyen · P. · Merckx · J. · Fleurant · A.
Introduction

HIV is a major public health issue affecting millions globally. Women and girls account for 46% of new HIV infections in 2022 and approximately 1.3 million females become pregnant every year. Vertical transmission of HIV from persons living with HIV (PLHIV) to infants may occur through different modalities, such as through breast/chest feeding. Notably, 82% of PLHIV who chose to breast/chest feed are on antiretroviral therapy (ART) when feeding their infants. Precise estimates of the risk of postpartum transmission to infants during breast/chest feeding at varying viral load levels remain a significant gap in the literature.

Methods and analysis

A rapid systematic search of electronic databases will be conducted from January 2005 to the present, including Medline, Embase and Global Health. The objective of this rapid review is to explore and assess the available evidence on the effect of varying viral load levels on the risk of HIV transmission to infants during breast/chest feeding when the birthing or gestational parent living with HIV is on ART. Study characteristics will be summarised and reported to support the narrative summary of the findings. The focus will be on the absolute risk of HIV transmission from birthing parent to infant during chest/breast feeding. The findings will also be stratified by month, including the risk of HIV transmission for 6 months and greater than 6 months postpartum. We will ascertain the risk of bias using A Measurement Tool to Assess Systematic Reviews 2, Quality of Prognosis Studies and Downs and Black checklist for the appropriate study type. A summary score will not be calculated, rather the strengths and limitations of the studies will be narratively described.

Ethics and dissemination

No human subjects will be involved in the research. The findings of this rapid review will inform a future systematic review and will be disseminated through peer-reviewed publications, presentations and conferences.

PROSPERO registration number

CRD42024499393.

Contextually appropriate nurse staffing models: a realist review protocol

Introduction

Decisions about nurse staffing models are a concern for health systems globally due to workforce retention and well-being challenges. Nurse staffing models range from all Registered Nurse workforce to a mix of differentially educated nurses and aides (regulated and unregulated), such as Licensed Practical or Vocational Nurses and Health Care Aides. Systematic reviews have examined relationships between specific nurse staffing models and client, staff and health system outcomes (eg, mortality, adverse events, retention, healthcare costs), with inconclusive or contradictory results. No evidence has been synthesised and consolidated on how, why and under what contexts certain staffing models produce different outcomes. We aim to describe how we will (1) conduct a realist review to determine how nurse staffing models produce different client, staff and health system outcomes, in which contexts and through what mechanisms and (2) coproduce recommendations with decision-makers to guide future research and implementation of nurse staffing models.

Methods and analysis

Using an integrated knowledge translation approach with researchers and decision-makers as partners, we are conducting a three-phase realist review. In this protocol, we report on the final two phases of this realist review. We will use Citation tracking, tracing Lead authors, identifying Unpublished materials, Google Scholar searching, Theory tracking, ancestry searching for Early examples, and follow-up of Related projects (CLUSTER) searching, specifically designed for realist searches as the review progresses. We will search empirical evidence to test identified programme theories and engage stakeholders to contextualise findings, finalise programme theories document our search processes as per established realist review methods.

Ethics and dissemination

Ethical approval for this study was provided by the Health Research Ethics Board of the University of Alberta (Study ID Pro00100425). We will disseminate the findings through peer-reviewed publications, national and international conference presentations, regional briefing sessions, webinars and lay summary.

Australian trial of behavioural activation for people with schizophrenia experiencing negative symptoms: a feasibility randomised controlled trial protocol

Por: Muyambi · K. · Walsh · S. · Dettwiller · P. · Tan · K. L. · Dennis · S. · Bressington · D. · Gray · R. J. · McCall · A. · Jones · M.
Introduction

Negative symptoms are frequently experienced by people with schizophrenia. People with negative symptoms often have impaired social functioning and reduced quality of life. There is some evidence that cognitive–behavioural therapy results in a modest reduction in negative symptoms. Behavioural activation may be an effective alternative treatment for negative symptoms.The study aims to examine the feasibility and acceptability of implementing a behavioural activation trial delivered in three community mental health services in South Australia to support adult consumers experiencing negative symptoms of schizophrenia.

Method and analysis

This randomised controlled study will recruit a total of 60 consumers aged 18 years or above with mild-moderate negative symptoms of schizophrenia. The consumers will be randomly allocated to receive behavioural activation plus usual mental healthcare or usual mental healthcare alone. The intervention group will receive twelve 30 min sessions of behavioural activation, which will be delivered twice weekly over 6 weeks. In addition, we aim to recruit nine mental health workers from the three rural mental health services who will complete a 10-week online training programme in behavioural activation. Changes in negative symptoms of schizophrenia and depressive symptoms will be assessed at three time points: (a) at baseline, at 6 weeks and 3 month follow-ups. Changes in health-related quality of life (Short Form F36; secondary outcome) will be assessed at two time points: (a) at baseline and (b) immediately at postintervention after 6 weeks. At the end of the trial, interviews will be conducted with purposively selected mental health workers and consumers. Descriptive statistics and thematic analysis will be used to assess feasibility and acceptability.

Ethics and dissemination

The findings from our feasibility study will inform the design of a fully powered randomised controlled trial to test the effectiveness of behavioural activation as a treatment for negative symptoms in schizophrenia. The study protocol was approved by the Central Adelaide Local Health Network Human Research Ethics Committee. The findings from this study will be disseminated through peer-reviewed scientific journals and conferences.

Trial registration number

ACTRN12623000348651p.

Effectiveness and cost-effectiveness of a 12-month automated text message intervention for weight management in postpartum women with overweight or obesity: protocol for the Supporting MumS (SMS) multisite, parallel-group, randomised controlled trial

Por: Gallagher · D. · Spyreli · E. · Anderson · A. S. · Bridges · S. · Cardwell · C. R. · Coulman · E. · Dombrowski · S. U. · Free · C. · Heaney · S. · Hoddinott · P. · Kee · F. · McDowell · C. · McIntosh · E. · Woodside · J. V. · McKinley · M. C.
Introduction

The reproductive years can increase women’s weight-related risk. Evidence for effective postpartum weight management interventions is lacking and engaging women during this life stage is challenging. Following a promising pilot evaluation of the Supporting MumS intervention, we assess if theory-based and bidirectional text messages to support diet and physical activity behaviour change for weight loss and weight loss maintenance, are effective and cost-effective for weight change in postpartum women with overweight or obesity, compared with an active control arm receiving text messages on child health and development.

Methods and analysis

Two-arm, parallel-group, assessor-blind randomised controlled trial with cost-effectiveness and process evaluations. Women (n=888) with body mass index (BMI) ≥25 kg/m2 and within 24 months of giving birth were recruited via community and National Health Service pathways through five UK sites targeting areas of ethnic and socioeconomic diversity. Women were 1:1 randomised to the intervention or active control groups, each receiving automated text messages for 12 months. Data are collected at 0, 6, 12 and 24 months. The primary outcome is weight change at 12 months from baseline, compared between groups. Secondary outcomes include weight change (24 months) and waist circumference (cm), proportional weight gain (>5 kg), BMI (kg/m2), dietary intake, physical activity, infant feeding and mental health (6, 12 and 24 months, respectively). Economic evaluation examines health service usage and personal expenditure, health-related quality of life and capability well-being to assess cost-effectiveness over the trial and modelled lifetime. Cost–utility analysis examines cost per quality-adjusted life-years gained over 24 months. Mixed-method process evaluation explores participants’ experiences and contextual factors impacting outcomes and implementation. Stakeholder interviews examine scale-up and implementation.

Ethics and dissemination

Ethical approval was obtained before data collection (West of Scotland Research Ethics Service Research Ethics Committee (REC) 4 22/WS/0003). Results will be published via a range of outputs and audiences.

Trial registration number

ISRCTN16299220.

EvolvRehab-MoveWell telerehabilitation for stroke survivors: study protocol for a feasibility with embedded initial proof-of-concept study

Por: Perks · J. · McBride · P. · Mansoubi · M. · Clatworthy · P. · Hulme · C. · Taylor · G. · Warner · M. · Dawes · H.
Introduction

Stroke is a leading cause of disability throughout the world. Unilateral upper limb impairment is common in people who have had a stroke. As a result of impaired upper limb function, people who have had a stroke often employ abnormal ‘compensatory’ movements. In the short term, these compensatory movements allow the individual to complete tasks, though long-term movement in this manner can lead to limitations. Telerehabilitation offers the provision of rehabilitation services to patients at a remote location using information and communication technologies. ‘EvolvRehab’ is one such telerehabilitation system, which uses activities to assess and correct compensatory upper body movements, although the feasibility of its use is yet to be determined in National Health Service services. Using EvolvRehab, we aim to assess the feasibility of 6 weeks telerehabilitation in people after a stroke.

Methods and analysis

A multisite feasibility study with embedded design phase. Normally distributed data will be analysed using paired samples t-tests; non-normally distributed data will be analysed using related samples Wilcoxon signed rank tests. Thematic content analysis of interview transcripts will be used to investigate the usability and perceived usefulness of the EvolvRehab kit.

Ethics and dissemination

This study has received ethical approval from Solihull Research Ethics Committee (REC reference: 23/WM/0054). Dissemination will be carried out according to the dissemination plan co-written with stroke survivors, including academic publications and presentations; written reports; articles in publications of stakeholder organisations; presentations to and publications for potential customers.

Trial registration number

NCT05875792.

Cohort profile: EFTER-COVID - a Danish nationwide cohort for assessing the long-term health effects of the COVID-19 pandemic

Por: Sorensen · A. I. V. · Bager · P. · Nielsen · N. M. · Koch · A. · Spiliopoulos · L. · Hviid · A. · Ethelberg · S.
Purpose

To follow SARS-CoV-2-infected persons up to 18 months after a positive test in order to assess the burden and nature of post acute symptoms and health problems.

Participants

Persons in Denmark above 15 years of age, who were tested positive for SARS-CoV-2 during 1 September 2020 to 21 February 2023 using a RT-PCR test. As a reference group, three test-negative individuals were selected for every two test-positive individuals by matching on test date.

Findings to date

In total, 2 427 913 invitations to baseline questionnaires have been sent out and 839 528 baseline questionnaires (34.5%) have been completed. Females, the age group 50–69 years, Danish-born and persons, who had received at least one SARS-CoV-2 vaccination booster dose were more likely to participate. Follow-up questionnaires were sent at 2, 4, 6, 9, 12 and 18 months after the test, with response rates at 42%–54%.

Future plans

New participants have been recruited on a daily basis from 1 August 2021 to 23 March 2023. Data collection will continue until the last follow-up questionnaires (at 18 months after test) have been distributed in August 2024.

Do patients with nephrotic syndrome have an increased risk of osteoporosis? A nationwide population-based retrospective cohort study in Taiwan

Por: Liao · C.-Y. · Chung · C.-H. · Wei · K.-Y. · Tseng · M.-F. · Lin · F.-H. · Tsao · C.-H. · Chien · W.-C. · Chu · P. · Wu · C.-C.
Objectives

To evaluate whether nephrotic syndrome (NS) and further corticosteroid (CS) use increase the risk of osteoporosis in Asian population during the period January 2000–December 2010.

Design

Nationwide population-based retrospective cohort study.

Setting

All healthcare facilities in Taiwan.

Participants

A total of 28 772 individuals were enrolled.

Interventions

26 614 individuals with newly diagnosed NS between 2000 and 2010 were identified and included in out study. 26 614 individuals with no NS diagnosis prior to the index date were age matched as controls. Diagnosis of osteoporosis prior to the diagnosis of NS or the same index date was identified, age, sex and NS-associated comorbidities were adjusted.

Primary outcome measure

To identify risk differences in developing osteoporosis among patients with a medical history of NS.

Results

After adjusting for covariates, osteoporosis risk was found to be 3.279 times greater in the NS cohort than in the non-NS cohort, when measured over 11 years after NS diagnosis. Stratification revealed that age older than 18 years, congestive heart failure, hyperlipidaemia, chronic kidney disease, liver cirrhosis and NS-related disease including diabetes mellitus, hepatitis B infection, hepatitis C infection, lymphoma and hypothyroidism, increased the risk of osteoporosis in the NS cohort, compared with the non-NS cohort. Additionally, osteoporosis risk was significantly higher in NS patients with CS use (adjusted HR (aHR)=3.397). The risk of osteoporosis in NS patients was positively associated with risk of hip and vertebral fracture (aHR=2.130 and 2.268, respectively). A significant association exists between NS and subsequent risk for osteoporosis.

Conclusion

NS patients, particularly those treated with CS, should be evaluated for subsequent risk of osteoporosis.

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial

Por: Gomber · A. · Valeta · F. · Coates · M. M. · Trujillo · C. · Ferrari · G. · Boti · M. · Kumwenda · K. · Mailosi · B. · Nakotwa · D. · Drown · L. · Wroe · E. B. · Thapa · A. · Mithi · V. · Matanje · B. · Msekandiana · A. · Park · P. H. · Kachimanga · C. · Bukhman · G. · Ruderman · T. · Adler
Objectives

To assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes.

Design

A 2:1 open randomised controlled feasibility trial.

Setting

Two Partners In Health-supported Ministry of Health-run first-level district hospitals in Neno, Malawi.

Participants

45 people living with type 1 diabetes (PLWT1D).

Interventions

Participants were randomly assigned to Dexcom G6 CGM (n=30) use or usual care (UC) (n=15) consisting of Safe-Accu glucose monitors and strips. Both arms received diabetes education.

Outcomes

Primary outcomes included fidelity, appropriateness and severe adverse events. Secondary outcomes included change in haemoglobin A1c (HbA1c), acceptability, time in range (CGM arm only) SD of HbA1c and quality of life.

Results

Participants tolerated CGM well but were unable to change their own sensors which resulted in increased clinic visits in the CGM arm. Despite the hot climate, skin rashes were uncommon but cut-out tape overpatches were needed to secure the sensors in place. Participants in the CGM arm had greater numbers of dose adjustments and lifestyle change suggestions than those in the UC arm. Participants in the CGM arm wore their CGM on average 63.8% of the time. Participants in the UC arm brought logbooks to clinic 75% of the time. There were three hospitalisations all in the CGM arm, but none were related to the intervention.

Conclusions

This is the first randomised controlled trial conducted on CGM in a rural region of a low-income country. CGM was feasible and appropriate among PLWT1D and providers, but inability of participants to change their own sensors is a challenge.

Trial registration number

PACTR202102832069874.

Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study

Por: Thapa · A. · Chibvunde · S. · Schwartz · L. · Trujillo · C. · Ferrari · G. · Drown · L. · Gomber · A. · Park · P. H. · Matanje · B. · Msekandiana · A. · Kachimanga · C. · Bukhman · G. · Ruderman · T. · Adler · A. J.
Objectives

The purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals in Malawi.

Design

We conducted semistructured qualitative interviews among PLWT1D and healthcare providers participating in the study. Standardised interview guides elicited perspectives on the appropriateness and acceptability of CGM use for PLWT1D and their providers, and provider perspectives on the effectiveness of CGM use in Malawi. Data were coded using Dedoose software and analysed using a thematic approach.

Setting

First-level hospitals in Neno district, Malawi.

Participants

Participants were part of a randomised controlled trial focused on CGM at first-level hospitals in Neno district, Malawi. Pretrial and post-trial interviews were conducted for participants in the CGM and usual care arms, and one set of interviews was conducted with providers.

Results

Eleven PLWT1D recruited for the CGM randomised controlled trial and five healthcare providers who provided care to participants with T1D were included. Nine PLWT1D were interviewed twice, two were interviewed once. Of the 11 participants with T1D, six were from the CGM arm and five were in usual care arm. Key themes emerged regarding the appropriateness and effectiveness of CGM use in lower resource setting. The four main themes were (a) patient provider relationship, (b) stigma and psychosocial support, (c) device usage and (d) clinical management.

Conclusions

Participants and healthcare providers reported that CGM use was appropriate and acceptable in the study setting, although the need to support it with health education sessions was highlighted. This research supports the use of CGM as a component of personalised diabetes treatment for PLWT1D in resource constraint settings.

Trial registration number

PACTR202102832069874; Post-results.

Bacterial growth in patients with low back pain and Modic changes: protocol of a multicentre, case-control biopsy study

Por: Rolfsen · M. P. · Gammelsrud · K. W. · Espeland · A. · Braten · L. C. · Mjones · S. B. · Austevoll · I. · Dolatowski · F. C. · Arrestad · M. B. · Toppe · M. K. · Orlien · I. E. · Holberg-Petersen · M. · Fagerland · M. · Zwart · J.-A. · Storheim · K. · Hellum · C.
Introduction

Bacterial infection and Modic changes (MCs) as causes of low back pain (LBP) are debated. Results diverged between two randomised controlled trials examining the effect of amoxicillin with and without clavulanic acid versus placebo on patients with chronic LBP (cLBP) and MCs. Previous biopsy studies have been criticised with regard to methods, few patients and controls, and insufficient measures to minimise perioperative contamination. In this study, we minimise contamination risk, include a control group and optimise statistical power. The main aim is to compare bacterial growth between patients with and without MCs.

Methods and analysis

This multicentre, case–control study examines disc and vertebral body biopsies of patients with cLBP. Cases have MCs at the level of tissue sampling, controls do not. Previously operated patients are included as a subgroup. Tissue is sampled before antibiotic prophylaxis with separate instruments. We will apply microbiological methods and histology on biopsies, and predefine criteria for significant bacterial growth, possible contamination and no growth. Microbiologists, surgeons and pathologist are blinded to allocation of case or control. Primary analysis assesses significant growth in MC1 versus controls and MC2 versus controls separately. Bacterial disc growth in previously operated patients, patients with large MCs and growth from the vertebral body in the fusion group are all considered exploratory analyses.

Ethics and dissemination

The Regional Committees for Medical and Health Research Ethics in Norway (REC South East, reference number 2015/697) has approved the study. Study participation requires written informed consent. The study is registered at ClinicalTrials.gov (NCT03406624). Results will be disseminated in peer-reviewed journals, scientific conferences and patient fora.

Trial registration number

NCT03406624.

Factors influencing optimal diabetes care and clinical outcomes in Thai patients with type 2 diabetes mellitus: a multilevel modelling analysis

Por: Surawit · A. · Pongkunakorn · T. · Manosan · T. · Mongkolsucharitkul · P. · Chamnan · P. · Suvarnabhumi · K. · Puangpet · T. · Suta · S. · Pumeiam · S. · Pinsawas · B. · Ophakas · S. · Pisitpornsuk · S. · Utchin · C. · Mayurasakorn · K.
Background

Increasing levels of poor glycaemic control among Thai patients with type 2 diabetes mellitus (T2DM) motivated us to compare T2DM care between urban and suburban primary care units (PCUs), to identify gaps in care, and to identify significant factors that may influence strategies to enhance the quality of care and clinical outcomes in this population.

Methods

We conducted a cross-sectional study involving 2160 patients with T2DM treated at four Thai PCUs from 2019 to 2021, comprising one urban and three suburban facilities. Using mixed effects logistic regression, we compared care factors between urban and suburban PCUs.

Results

Patients attending suburban PCUs were significantly more likely to undergo eye (adjusted OR (AOR): 1.83, 95% CI 1.35 to 1.72), foot (AOR: 1.61, 95% CI 0.65 to 4.59) and HbA1c (AOR: 1.66, 95% CI 1.09 to 2.30) exams and achieved all ABC (HbA1c, blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C)) goals (AOR: 2.23, 95% CI 1.30 to 3.83). Conversely, those at an urban PCU were more likely to undergo albuminuria exams. Variables significantly associated with good glycaemic control included age (AOR: 1.51, 95% CI 1.31 to 1.79), T2DM duration (AOR: 0.59, 95% CI 0.41 to 0.88), FAACE (foot, HbA1c, albuminuria, LDL-C and eye) goals (AOR: 1.23, 95% CI 1.12 to 1.36) and All8Q (AOR: 1.20, 95% CI 1.05 to 1.41). Chronic kidney disease (CKD) was significantly linked with high triglyceride and HbA1c levels (AOR: 5.23, 95% CI 1.21 to 7.61). Elevated HbA1c levels, longer T2DM duration, insulin use, high systolic BP and high lipid profile levels correlated strongly with diabetic retinopathy (DR) and CKD progression.

Conclusion

This highlights the necessity for targeted interventions to bridge urban–suburban care gaps, optimise drug prescriptions and implement comprehensive care strategies for improved glycaemic control, DR prevention and CKD progression mitigation among in Thai patients with T2DM. The value of the clinical target aggregate (ABC) and the process of care aggregate (FAACE) was also conclusively demonstrated.

Factors influencing the outcomes of non-pharmacological interventions for managing fatigue across the lifespan of people living with musculoskeletal (MSK) conditions: a scoping review protocol

Por: Fishpool · K. · Young · G. · Ciurtin · C. · Cramp · F. · Erhieyovwe · E. O. · Farisogullari · B. · Macfarlane · G. J. · Machado · P. M. · Pearson · J. · Santos · E. · Dures · E.
Introduction

Fatigue is an important and distressing symptom for many people living with chronic musculoskeletal (MSK) conditions. Many non-pharmacological interventions have been investigated in recent years and some have been demonstrated to be effective in reducing fatigue and fatigue impact, however, there is limited guidance for clinicians to follow regarding the most appropriate management options. The objective of this scoping review is to understand and map the extent of evidence in relation to the factors that relate to the outcome of non-pharmacological interventions on MSK condition-related fatigue across the lifespan.

Methods and analysis

This scoping review will include evidence relating to people of all ages living with chronic MSK conditions who have been offered a non-pharmacological intervention with either the intention or effect of reducing fatigue and its impact. Databases including AMED, PsycINFO, CINAHLPlus, MEDLINE, EMBASE and Scopus will be searched for peer-reviewed primary research studies published after 1 January 2007 in English language. These findings will be used to identify factors associated with successful interventions and to map gaps in knowledge.

Ethics and dissemination

Ethical approval was not required for this review. Findings will be disseminated by journal publications, conference presentations and by communicating with relevant healthcare and charity organisations.

Burden of COVID-19 pandemic on tuberculosis hospitalisation patterns at a tertiary care hospital in Rajasthan, India: a retrospective analysis

Por: Rajotiya · S. · Mishra · S. · Singh · A. K. · Debnath · S. · Raj · P. · Singh · P. · Bareth · H. · Nakash · P. · Sharma · A. · Singh · M. · Nathiya · D. · Joshi · N. · Tomar · B. S.
Objective

This study aimed to investigate the burden of the COVID-19 pandemic on tuberculosis (TB) trends, patient demographics, disease types and hospitalisation duration within the Respiratory Medicine Department over three distinct phases: pre-COVID-19, COVID-19 and post-COVID-19.

Design

Retrospective analysis using electronic medical records of patients with TB admitted between June 2018 and June 2023 was done to explore the impact of COVID-19 on patients with TB. The study employed a meticulous segmentation into pre-COVID-19, COVID-19 and post-COVID-19 eras.

Setting

National Institute of Medical Science Hospital in Jaipur, Rajasthan, India.

Primary and secondary outcome measures

Primary outcome includes patients admitted to the Respiratory Medicine Department of the hospital and secondary outcome involves the duration of hospital stay.

Results

The study encompassed 1845 subjects across the three eras, revealing a reduction in TB incidence during the post-COVID-19 era compared with the pre-COVID-19 period (p

Conclusion

The study underscores the influence of the COVID-19 pandemic on the TB landscape and hospitalisation dynamics. Notably, patient burden of TB declined during the COVID-19 era, with a decline in the post-COVID-19 era compared with the pre-COVID-19 era. Prolonged hospitalisation in the post-COVID-19 period indicates the need for adaptive healthcare strategies and the formulation of public health policies in a post-pandemic context. These findings contribute to a comprehensive understanding of the evolving TB scenario, emphasising the necessity for tailored healthcare approaches in the aftermath of a global health crisis.

Hospital at home for elderly acute patients: a study protocol for a randomised controlled trial

Por: Thomsen · A. M. L. · Tayyari · N. · Duvald · I. · Kirkegaard · H. · Obel · B. · Nielsen · C. P.
Introduction

The increasing elderly population has led to a growing demand for healthcare services. A hospital at home treatment model offers an alternative to standard hospital admission, with the potential to reduce readmission and healthcare consumption while improving patients’ quality of life. However, there is little evidence regarding hospital at home treatment in a Danish setting. This article describes the protocol for a randomised controlled trial (RCT) comparing standard hospital admission to hospital at home treatment. The main aim of the intervention is to reduce 30-day acute readmission after discharge and improve the quality of life of elderly acute patients.

Methods and analysis

A total of 849 elderly acute patients will be randomised in a 1:2 ratio to either the control or intervention group in the trial. The control group will receive standard hospital treatment in a hospital emergency department while the intervention group will receive treatment at home. The primary outcomes of the trial are the rate of 30-day acute readmission and quality of life, assessed using the European Quality of Life-5 Dimensions-5-Level instrument. Primary analyses are based on the intention-to-treat principle. Secondary outcomes are basic functional mobility, resource use in healthcare, primary and secondary healthcare cost, incremental cost-effectiveness ratio, and the mortality rate 3 months after discharge.

Ethics and dissemination

The RCT was approved by the Ethical Committee, Central Denmark Region (no. 1-10-72-67-20). Results will be presented at relevant national and international meetings and conferences and will be published in international peer-reviewed journals. Furthermore, we plan to communicate the results to relevant stakeholders in the Danish healthcare system.

Trial registration number

NCT05360914.

Prevalence and health effects of post-COVID-19 condition in Africa: a scoping review protocol

Por: Ansah · E. W. · Salu · P. K. · Daanko · M. S. · Banaaleh · D. N. · Amoadu · M.
Introduction

SARS-CoV-2 pandemic has caused global devastations in the social, economic and health systems of every nation, but disproportionately the nations in Africa. Apart from its grave effects on the global systems, is the persistence of post-COVID-19 condition in individuals infected with the virus. Therefore, the aim of this scoping review is to collate and summarise the existing research evidence about the prevalence and health effects of post-COVID-19 infection conditions in Africa.

Methods and analysis

Five main databases will be thoroughly searched from 1 September 2023 to 30 April 2024, for eligible articles based on the inclusion and exclusion criteria. These databases include PubMed, Central, Scopus, Dimensions AI and JSTOR. Meanwhile, Arksey and O’Malley guidelines will guide this scoping review using article published between 1 January 2020 and 30 April 2024. This review will provide a useful insight into the prevalence of the post-COVID-19 symptoms and their health effects within the population in Africa. The results and findings of the review will be valuable for health system interventions, including restructuring and reorientation of health systems in the continent.

Ethics and dissemination

This scoping review will involve analysis of secondary data, therefore, no ethical approval is needed. Dissemination of the results will be done through international journals and available research conferences.

Cost-effectiveness of pessary therapy versus surgery for symptomatic pelvic organ prolapse: an economic evaluation alongside a randomised non-inferiority controlled trial

Por: Ben · A. J. · van der Vaart · L. R. · E. Bosmans · J. · Roovers · J.-P. W. R. · Lagro-Janssen · A. L. M. · van der Vaart · C. H. · Vollebregt · A. · PEOPLE group · Milani · Bon · Bongers · Bos · Broekman · Dietz · van Eijndhoven · Hakvoort · Janszen · Kluivers · Link · Massop-Hel
Objective

To evaluate the cost-effectiveness of pessary therapy as an initial treatment option compared with surgery for moderate to severe pelvic organ prolapse (POP) symptoms in secondary care from a healthcare and a societal perspective.

Design

Economic evaluation alongside a multicentre randomised controlled non-inferiority trial with a 24-month follow-up.

Setting

21 hospitals in the Netherlands, recruitment conducted between 2015 and 2022.

Participants

1605 women referred to secondary care with symptomatic prolapse stage ≥2 were requested to participate. Of them, 440 women gave informed consent and were randomised to pessary therapy (n=218) or to surgery (n=222) in a 1:1 ratio stratified by hospital.

Interventions

Pessary therapy and surgery.

Primary and secondary outcome measures

The Patient Global Impression of Improvement (PGI-I), a 7-point scale dichotomised into successful versus unsuccessful, with a non-inferiority margin of –10%; quality-adjusted life-years (QALYs) measured by the EQ-5D-3L; healthcare and societal costs were based on medical records and the institute for Medical Technology Assessment questionnaires.

Results

For the PGI-I, the mean difference between pessary therapy and surgery was –0.05 (95% CI –0.14; 0.03) and –0.03 (95% CI –0.07; 0.002) for QALYs. In total, 54.1% women randomised to pessary therapy crossed over to surgery, and 3.6% underwent recurrent surgery. Healthcare and societal costs were significantly lower in the pessary therapy (mean difference=–1807, 95% CI –2172; –1446 and mean difference=–1850, 95% CI –2349; –1341, respectively). The probability that pessary therapy is cost-effective compared with surgery was 1 at willingness-to-pay thresholds between 0 and 20 000/QALY gained from both perspectives.

Conclusions

Non-inferiority of pessary therapy regarding the PGI-I could not be shown and no statistically significant differences in QALYs between interventions were found. Due to significantly lower costs, pessary therapy is likely to be cost-effective compared with surgery as an initial treatment option for women with symptomatic POP treated in secondary care.

Trial registration number

NTR4883.

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