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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.

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.

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.

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.

Acute watery diarrhoea cases during cholera outbreak in Syria: a cohort study

Por: Arnaout · A. Y. · Nerabani · Y. · Sawas · M. N. · Alhejazi · T. J. · Farho · M. A. · Arnaout · K. · Alshaker · H. · Shebli · B. · Helou · M. · Mobaied · B. B. · Mouti · M. B. · Kady · F. · Aljarad · Z. · Aleppo University Hospital Team · shalabi · Dasouki · Breij · Shheibar · Alabdull
Objectives

The aim of this study is a descriptive presentation of cases of acute watery diarrhoea (AWD) that were presented to Aleppo University Hospital (AUH) during the recent cholera outbreak in Syria.

Design

Prospective, observational, cohort study.

Setting and participants

A total of 1061 patients with AWD were admitted to AUH during the timeframe of 20 September 2022 to 20 October 2022. The data collection was done through a structured questionnaire. This includes comprehensive clinical observation, laboratory analyses, therapeutic interventions and holistic case evaluations.

Results

The analysis has revealed notable insights: a predominant proportion of patients (58.6%) were residents from urban areas and 40.3% were residents from rural areas. Intriguingly, a diverse range of potential infection sources emerged from patient data within our hospital, including uncontrolled well water, vegetables and faecal-oral transmission through contaminated street/fast food. At discharge, most patients were in good health (79.7%), followed by moderate health (17.6%) and poor health (2.3%), with a minimal percentage dying before discharge (0.4%). The most common complications reported at admission and during hospitalisation included electrolyte imbalance (28.2%), followed by severe dehydration (16.3%). In the follow-up period, the majority of patients exhibited good health (81.0%). Older patients (>60 years) had poorer outcomes, with 8.4% having poor health and 4.2% death rate.

Conclusions

The study found results consistent with previous AWD outbreaks in developing countries like Yemen, Nigeria and Lebanon. Preventative measures like improving water sanitation and hygiene practices are essential to prevent future outbreaks and ease the strain on healthcare systems. Therefore, future studies must investigate the risk factors that increase the spread and the severity of the disease and investigate the best management method.

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.

System-wide governance challenges of the Ebonyi State Malaria Elimination Programme and recommendations for malaria health system strengthening: a qualitative study among stakeholders in Ebonyi state, Nigeria

Por: Omale · U. I. · Ogbonnaya · L. U. · Iyare · O. · Nnachi · O. O.
Objectives

The burden of malaria has persistently been high in Ebonyi state and Nigeria despite long-standing collaborations with international partners with huge and increased amounts of financial investments. We explored the system-wide governance challenges of the Ebonyi State Malaria Elimination Programme (SMEP) and the factors responsible in order to make recommendations for malaria health system strengthening.

Design

We did a qualitative study informed by the health system governance framework by Mikkelsen-Lopez et al and Savedoff’s concept of governance.

Setting and participants

Between 18 October 2022 and 8 November 2022, 25 semistructured face-to-face in-depth interviews were conducted in English with purposively selected key stakeholders in the Ebonyi SMEP aged 18 years or older with at least 2 years of involvement in the SMEP and who gave consent.

Analysis

Data were analysed deductively and the analytical strategy was informed by the framework method for the analysis of qualitative data by Gale et al.

Results

Many system-wide governance challenges of the SMEP were identified including the absence of state’s strategic vision and plans for malaria elimination; very weak primary and secondary healthcare systems; inadequate financial allocation and untimely release of budgeted funds by the state government; lack of human resources for health and very poor mosquito net distribution system. Other challenges were inadequate stakeholders’ participation; poor accountability culture; impaired transparency and corruption and impaired ability to address corruption. The fundamental responsible factors were the lack of state government’s concern for people’s welfare and lack of interest and commitment to the malaria elimination effort, chronic non-employment of staff and lack of human resources in the entire health sector including SMEP, and nepotism and godfatherism.

Conclusions

The system-wide governance challenges and the responsible factors call for changing the ‘business as usual’ and refocusing on strengthening malaria health system governance in addressing the persisting malaria health problems in Ebonyi state (and Nigeria).

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.

Retrospective study investigating naloxone prescribing and cost in US Medicaid and Medicare patients

Por: Manko · C. D. · Ahmed · M. S. · Harrison · L. R. · Kodavatiganti · S. A. · Lugo · N. · Konadu · J. O. · Khan · F. · Massari · C. A. · Sealey · T. K. · Addison · M. E. · Mbah · C. N. · McCall · K. L. · Fraiman · J. B. · Piper · B. J.
Background

Opioid overdoses in the USA have increased to unprecedented levels. Administration of the opioid antagonist naloxone can prevent overdoses.

Objective

This study was conducted to reveal the pharmacoepidemiologic patterns in naloxone prescribing to Medicaid patients from 2018 to 2021 as well as Medicare in 2019.

Design

Observational pharmacoepidemiologic study

Setting

US Medicare and Medicaid naloxone claims

Intervention

The Medicaid State Drug Utilisation Data File was utilised to extract information on the number of prescriptions and the amount prescribed of naloxone at a national and state level. The Medicare Provider Utilisation and Payment was also utilised to analyse prescription data from 2019.

Outcome measures

States with naloxone prescription rates that were outliers of quartile analysis were noted.

Results

The number of generic naloxone prescriptions per 100 000 Medicaid enrollees decreased by 5.3%, whereas brand naloxone prescriptions increased by 245.1% from 2018 to 2021. There was a 33.1-fold difference in prescriptions between the highest (New Mexico=1809.5) and lowest (South Dakota=54.6) states in 2019. Medicare saw a 30.4-fold difference in prescriptions between the highest (New Mexico) and lowest states (also South Dakota) after correcting per 100 000 enrollees.

Conclusions

This pronounced increase in the number of naloxone prescriptions to Medicaid patients from 2018 to 2021 indicates a national response to this widespread public health emergency. Further research into the origins of the pronounced state-level disparities is warranted.

Coordination of oral anticoagulant care at hospital discharge (COACHeD): pilot randomised controlled trial

Por: Holbrook · A. · Troyan · S. · Telford · V. · Koubaesh · Y. · Vidug · K. · Yoo · L. · Deng · J. · Lohit · S. · Giilck · S. · Ahmed · A. · Talman · M. · Leonard · B. · Refaei · M. · Tarride · J.-E. · Schulman · S. · Douketis · J. · Thabane · L. · Hyland · S. · Ho · J. M.-W. · Siegal · D.
Objectives

To evaluate whether a focused, expert medication management intervention is feasible and potentially effective in preventing anticoagulation-related adverse events for patients transitioning from hospital to home.

Design

Randomised, parallel design.

Setting

Medical wards at six hospital sites in southern Ontario, Canada.

Participants

Adults 18 years of age or older being discharged to home on an oral anticoagulant (OAC) to be taken for at least 4 weeks.

Interventions

Clinical pharmacologist-led intervention, including a detailed discharge medication management plan, a circle of care handover and early postdischarge virtual check-up visits to 1 month with 3-month follow-up. The control group received the usual care.

Outcomes measures

Primary outcomes were study feasibility outcomes (recruitment, retention and cost per patient). Secondary outcomes included adverse anticoagulant safety events composite, quality of transitional care, quality of life, anticoagulant knowledge, satisfaction with care, problems with medications and health resource utilisation.

Results

Extensive periods of restriction of recruitment plus difficulties accessing patients at the time of discharge negatively impacted feasibility, especially cost per patient recruited. Of 845 patients screened, 167 were eligible and 56 were randomised. The mean age (±SD) was 71.2±12.5 years, 42.9% females, with two lost to follow-up. Intervention patients were more likely to rate their ability to manage their OAC as improved (17/27 (63.0%) vs 7/22 (31.8%), OR 3.6 (95% CI 1.1 to 12.0)) and their continuity of care as improved (21/27 (77.8%) vs 2/22 (9.1%), OR 35.0 (95% CI 6.3 to 194.2)). Fewer intervention patients were taking one or more inappropriate medications (7 (22.5%) vs 15 (60%), OR 0.19 (95% CI 0.06 to 0.62)).

Conclusion

This pilot randomised controlled trial suggests that a transitional care intervention at hospital discharge for older adults taking OACs was well received and potentially effective for some surrogate outcomes, but overly costly to proceed to a definitive large trial.

Trial registration number

NCT02777047.

Impact of a teaching hospital-based multidisciplinary telemedicine programme in Southwestern Colombia: a cross-sectional resource analysis

Por: Prada · S. I. · Toro · J. J. · Pena-Zarate · E. E. · Libreros-Pena · L. · Alarcon · J. · Escobar · M. F.
Background

Telemedicine, a method of healthcare service delivery bridging geographic distances between patients and providers, has gained prominence. This modality is particularly advantageous for outpatient consultations, addressing inherent barriers of travel time and cost.

Objective

We aim to describe economical outcomes towards the implementation of a multidisciplinary telemedicine service in a high-complexity hospital in Latin America, from the perspective of patients.

Design

A cross-sectional study was conducted, analysing the institutional data obtained over a period of 9 months, between April 2020 and December 2020.

Setting

A high-complexity teaching hospital located in Cali, Colombia.

Participants

Individuals who received care via telemedicine. The population was categorised into three groups based on their place of residence: Cali, Valle del Cauca excluding Cali and Outside of Valle del Cauca.

Outcome measures

Travel distance, time, fuel and public round-trip cost savings, and potential loss of productivity were estimated from the patient’s perspective.

Results

A total of 62 258 teleconsultations were analysed. Telemedicine led to a total distance savings of 4 514 903 km, and 132 886 hours. The estimated cost savings were US$680 822 for private transportation and US$1 087 821 for public transportation. Patients in the Outside of Valle del Cauca group experienced an estimated average time savings of 21.2 hours, translating to an average fuel savings of US$149.02 or an average savings of US$156.62 in public transportation costs. Areas with exclusive air access achieved a mean cost savings of US$362.9 per teleconsultation, specifically related to transportation costs.

Conclusion

Telemedicine emerges as a powerful tool for achieving substantial travel savings for patients, especially in regions confronting geographical and socioeconomic obstacles. These findings underscore the potential of telemedicine to bridge healthcare accessibility gaps in low-income and middle-income countries, calling for further investment and expansion of telemedicine services in such areas.

Anti-TNF (adalimumab) injection for the treatment of pain-predominant early-stage frozen shoulder: the Anti-Freaze-Feasibility randomised controlled trial

Por: Hopewell · S. · Srikesavan · C. · Evans · A. · Er · F. · Rangan · A. · Preece · J. · Francis · A. · Massa · M. S. · Feldmann · M. · Lamb · S. · Nanchahal · J.
Objective

The Anti-Freaze-F (AFF) trial assessed the feasibility of conducting a definitive trial to determine whether intra-articular injection of adalimumab can reduce pain and improve function in people with pain-predominant early-stage frozen shoulder.

Design

Multicentre, randomised feasibility trial, with embedded qualitative study.

Setting

Four UK National Health Service (NHS) musculoskeletal and related physiotherapy services.

Participants

Adults ≥18 years with new episode of shoulder pain attributable to early-stage frozen shoulder.

Interventions

Participants were randomised (centralised computer generated 1:1 allocation) to either ultrasound-guided intra-articular injection of: (1) adalimumab (160 mg) or (2) placebo (saline (0.9% sodium chloride)). Participants and outcome assessors were blinded to treatment allocation. Second injection of allocated treatment (adalimumab 80 mg) or equivalent placebo was administered 2–3 weeks later.

Primary feasibility objectives

(1) Ability to screen and identify participants; (2) willingness of eligible participants to consent and be randomised; (3) practicalities of delivering the intervention; (4) SD of the Shoulder Pain and Disability Index (SPADI) score and attrition rate at 3 months.

Results

Between 31 May 2022 and 7 February 2023, 156 patients were screened of whom 39 (25%) were eligible. The main reasons for ineligibility were other shoulder disorder (38.5%; n=45/117) or no longer in pain-predominant frozen shoulder (33.3%; n=39/117). Of the 39 eligible patients, nine (23.1%) consented to be randomised (adalimumab n=4; placebo n=5). The main reason patients declined was because they preferred receiving steroid injection (n=13). All participants received treatment as allocated. The mean time from randomisation to first injection was 12.3 (adalimumab) and 7.2 days (placebo). Completion rates for patient-reported and clinician-assessed outcomes were 100%.

Conclusion

This study demonstrated that current NHS musculoskeletal physiotherapy settings yielded only small numbers of participants, too few to make a trial viable. This was because many patients had passed the early stage of frozen shoulder or had already formulated a preference for treatment.

Trial registration number

ISRCTN 27075727, EudraCT 2021-03509-23, ClinicalTrials.gov NCT05299242 (REC 21/NE/0214).

Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance

Por: Ramboarina · S. · Crucitti · T. · Gill · K. · Bekker · L. G. · Harding-Esch · E. M. · van de Wijgert · J. H. H. M. · Huynh · B.-T. · Fortas · C. · Harimanana · A. · Mayouya Gamana · T. · Randremanana · R. V. · Mangahasimbola · R. · Dziva Chikwari · C. · Kranzer · K. · Mackworth-You
Introduction

A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test—called the Genital InFlammation Test (GIFT)—for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.

Methods and analysis

We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical (‘diagnostic study’) and a qualitative, modelling and economic (‘an integration into care study’) part. The diagnostic study aims to evaluate GIFT’s performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.

Ethics and dissemination

Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.

The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).

Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).

Trial registration number

NCT05723484.

Sensorineural hearing loss among type 2 diabetic patients and its association with peripheral neuropathy: a cross-sectional study from a lower middle-income country

Por: Asghar · S. · Ali · Z. · Abdullah · A. · Naveed · S. · Ahmad · M. S. · Rafi · T. S. M.
Introduction

Despite potential links between diabetes and sensorineural hearing loss (SNHL), routine hearing assessments for diabetic patients are not standard practice. Our study aimed to investigate the prevalence of SNHL and its association with diabetes-related factors among patients with type 2 diabetes mellitus (T2DM).

Research design and methods

This cross-sectional study was conducted at the Diabetes Clinic, Jinnah Postgraduate Medical Centre, Karachi, Pakistan, from May to September 2021. A total of 396 patients fulfilling the inclusion criteria participated after informed consent. Data collection involved a sociodemographic profile, Michigan Neuropathy Screening Instrument examination followed by pure-tone audiometry and laboratory tests including haemoglobin A1C (HbA1c). HL was defined using better ear four-frequency pure-tone average of ≥26 dB HL and graded as per WHO criteria. Statistical analyses were performed using SPSS. 2, independent t-test and multinomial logistic regression analyses were applied. P

Results

Our study revealed a high prevalence of SNHL among patients with T2DM. Mild HL was seen in 55.8%, while 18.7% suffered from moderate HL. Common audiological symptoms included difficulty understanding speech in noisy surroundings (44.2%), balance problems (42.9%), sentence repetition (35.9%), tinnitus (32.3%) and differentiating consonants (31.1%). Hearing impairment predominantly affected low (0.25–0.5 kHz) and high (4–8 kHz) frequencies with a significant difference at 4 kHz among both sexes (t (394)=2.8, p=0.004). Peripheral neuropathy was significantly associated with SNHL on multinomial logistic regression after adjusting with age, sex, body mass index and the presence of any comorbidities. Diabetes duration, HbA1c or family history of diabetes was found unrelated to SNHL severity.

Conclusions

The study highlights the substantial prevalence of SNHL among patients with T2DM and emphasises the importance of targeted audiological care as part of a holistic approach to diabetes management. Addressing HL early may significantly improve communication and overall quality of life.

Assessment of the ability of Pseudomonas aeruginosa and Staphylococcus aureus to create biofilms during wound healing in a rat model treated with carboxymethyl cellulose/carboxymethyl chitosan hydrogel containing EDTA

Abstract

The primary objective of this study was to develop a carboxymethyl cellulose (CMC) and carboxymethyl chitosan (CMCS) hydrogel containing ethylene diamine tetra acetic acid (EDTA) as the materials for wound healing. CMC and CMCS solutions were prepared with a concentration of 4% (w/v). These solutions were made using normal saline serum with a concentration of 0.5% (v/v). Additionally, EDTA with the concentrations of 0.01%, 0.05%, 0.1%, 0.5%, 1%, and 2% (w/v) was included in the prepared polymer solution. The analysis of the hydrogels revealed that they possess porous structures with interconnected pores, with average in size 88.71 ± 5.93 μm. The hydrogels exhibited a swelling capacity of up to 60% of their initial weight within 24 h, as indicated by the weight loss and swelling measurements. The antibacterial experiments showed that the formulated CMC/CMCS/EDTA 0.5% hydrogel inhibited the growth of Staphylococcus aureus and Pseudomonas aeruginosa. Moreover, the produced hydrogels were haemocompatible and biocompatible. At the last stage, the evaluation of wound healing in the animal model demonstrated that the use of the produced hydrogels significantly improved the process of wound healing. Finally, the findings substantiated the effectiveness of the formulated hydrogels as the materials for promoting wound healing and antibacterial agents.

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