STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy (STRONGER): study protocol for a randomised, open label clinical trial in patients with persistent neurological symptoms after COVID-19 infection

Introduction
Increasing awareness of the high frequency, wide spectrum and disabling nature of symptoms that can persist following COVID-19 infection has prompted the investigation of management strategies. Our study aims to determine the effectiveness of atorvastatin on cognitive function, physical activity, mood, health-related quality of life and features of neurovascular impairment and neuroinflammation in adults with ongoing neurological symptoms after COVID-19 infection.

Methods and analysis
The STatin TReatment for COVID-19 to Optimise NeuroloGical recovERy study is an ongoing international, investigator-initiated and conducted, multicentre, prospective, randomised, open label, blinded endpoint trial with fixed time points for outcome assessments. A total of 410 participants with long covid neurological symptoms were planned to be randomly assigned to either the intervention group to receive 40 mg atorvastatin for 12 months or to a control group of no treatment, on top of usual care.

Ethics and dissemination
This study protocol was designed, implemented and reported, in accordance with the International Conference on Harmonisation guidelines for Good Clinical Practice, the National Health and Medical Research Council of Australia, the National Statement on Ethical Conduct in Human Research and with the ethical principles laid down in the World Medical Association Declaration of Helsinki. Central ethics committee approval was obtained from Sydney Local Health District Royal Prince Alfred Hospital Ethics (No: X21-0113 and 2021/ETH00777 10) in Australia. Site-specific ethics committee approvals were obtained elsewhere before any local study activities. All participants provided written informed consent.

Trial registration number
The study protocol is registered at Clinicaltrials.gov (NCT04904536).

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MultifocAL COntact Lenses for Myopia (MALCOLM) control in Australian children: a study protocol for a double-blind, contralateral eye, non-inferiority, randomised controlled clinical trial

Introduction
Myopia is the most common refractive error worldwide, but each dioptre increase in myopia leads to an increased risk of degenerative eye disease and permanent vision impairment. Soft contact lens (CL) designs have been developed to slow myopia and potentially reduce long-term risk, but there is still a need for additional designs of varied materials and parameters to cater for diverse patient needs. The MultifocAL COntact Lenses for Myopia control study aims to compare the efficacy of the Acuvue Oasys for Presbyopia (AOP) CL against the Food and Drug Administration approved MiSight 1-Day multifocal CL in controlling progressive myopia in children using a non-inferiority contralateral eye design.

Methods and analysis
A double-blind, contralateral eye, non-inferiority, randomised, controlled clinical trial will be conducted at University of New South Wales Sydney, Australia (UNSW). Children (6 to 12 years of age, inclusive) will be randomised to wear AOP in their right or left eye, with the MiSight 1-Day CL fitted to the contralateral eye. The primary outcome is the difference in axial length and cycloplegic objective refraction change between the two CLs over 12 months. Additional outcomes include quality of life, pupillometry and adherence to treatment. To achieve a statistical power of 80% to demonstrate non-inferiority of the AOP to the MiSight 1-Day and taking into consideration a 20% discontinuation rate, the calculated sample size is 72. This trial started recruitment during the recent COVID-19 pandemic in January 2021.

Ethics and dissemination
Ethics approval has been obtained from the UNSW Human Research Ethics Committee (HC200052), and the study complies with the Declaration of Helsinki and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guidelines. The results of this trial will be disseminated in peer-reviewed publications and conference presentations.

Trial registration number
ACTRN12620000159954, CTN-00 282–1 v2, NCT06887920.

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Effect modification and interaction between ethnicity and socioeconomic factors in severe COVID-19: analyses of linked national data for Scotland

Objective
Minority ethnic groups disproportionately experienced adverse COVID-19 outcomes, partly a consequence of disproportionate exposure to socioeconomic disadvantage and high-risk occupations. We examined whether minority ethnic groups were also disproportionately vulnerable to the consequences of socioeconomic disadvantage and high-risk occupations in Scotland.

Design
We investigated effect modification and interaction between area deprivation, education and occupational risk and ethnicity (assessed as both a binary white vs non-white variable and a multi-category variable) in relation to severe COVID-19 (hospitalisation or death). We used electronic health records linked to the 2011 census and Cox proportional hazards models, adjusting for age, sex and health board. We were principally concerned with additive interactions as a measure of vulnerability, estimated as the relative excess risk due to interaction (RERI).

Results
Analyses considered 3 730 837 individuals aged ≥16 years (with narrower age ranges for analyses focused on education and occupation). Severe COVID-19 risk was typically higher for minority ethnic groups and disadvantaged socioeconomic groups, but additive interactions were not consistent. For example, non-white ethnicity and highest deprivation level experienced elevated risk ((HR=2.7, 95% CI: 2.4, 3.2) compared with the white least deprived group. Additive interaction was not present (RERI=–0.1, 95% CI: –0.4, 0.2), this risk being less than the sum of risks of white ethnicity/highest deprivation level (HR=2.4, 95% CI: 2.3, 2.5) and non-white ethnicity/lowest deprivation level (1.4, 95% CI: 1.2, 1.7). Similarly, non-white ethnicity/no degree education (HR=2.5, 95% CI: 2.2, 2.7; RERI=–0.1, 95% CI: –0.4, 0.2) and non-white ethnicity/high-risk occupation (RERI=0.3, 95% CI: –0.2, 0.8) did not experience greater than additive risk. No clear evidence of effect modification was identified when using the multicategory ethnicity variable or on the multiplicative scale either.

Conclusion
We found no definitive evidence that minority ethnic groups were more vulnerable to the effect of social disadvantage on the risk of severe COVID-19.

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Tuberculosis service delivery challenges and their mitigations during the COVID-19 pandemic in Tanzania: a qualitative study

Objective
To describe challenges posed by COVID-19 on tuberculosis (TB) commodity supply, care cascade, active case finding and responses taken by healthcare workers (HCWs) and community health workers (CHWs) during the first year of the pandemic (March 2020 to February 2021).

Design
A qualitative descriptive study involving 25 in-depth interviews and 10 focus group discussions conducted in July 2022.

Setting
37 TB treatment facilities were purposively selected from seven regions due to high TB case notifications in 2019 and their provision of TB and COVID-19 services during the first year of the pandemic (March 2020 to February 2021).

Participants
Purposive selection of 58 HCWs and 55 CHWs who provided TB services in the first year of the COVID-19 pandemic.

Results
HCWs reported unusual stockouts and delayed receipt of GeneXpert cartridges and sputum containers. TB services faced a decline in client attendance, as clients were hesitant to undergo TB screening, sputum sample collection and contact tracing due to fear of contracting or being diagnosed with COVID-19 and subsequently being quarantined. To mitigate these challenges, HCWs used alternative containers for sputum sample collection, optimised GeneXpert cartridge use by prioritising GeneXpert testing for TB risk groups and diagnosed TB by microscopy, chest X-ray and sputum pooling method. Moreover, they extended drug refill schedules to minimise the risk of contracting COVID-19 in clinics. CHWs used mobile communication for client tracing and focused household visits on TB risk groups.

Conclusion
COVID-19 disrupted TB commodity availability and TB treatment-seeking behaviour. Adaptations like multi-month drug refills and optimised GeneXpert use supported the TB healthcare system’s resilience. While these adaptations offer valuable insights for strengthening TB service delivery, their effectiveness and sustainability require further evaluation. Thus, prospective studies could clarify their long-term impact. National Tuberculosis Program could consider adapting these practices postpandemic, with appropriate modifications to suit different contexts.

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National survey evaluating the introduction of new and alternative staffing models in intensive care (SEISMIC-R) in the UK

Objective
To report on the findings from a national survey of UK intensive care units (ICUs) exploring nurse staffing models currently in use and changes since COVID-19.

Design
A survey was designed and distributed using a web-based platform to senior unit leads via Intensive care national audit & research centre contacts.

Participants
Senior nurses representing the 331 National Health Service adult ICUs across the UK (across 231 hospitals/155 trusts), including the Channel Islands and Isle of Man.

Outcome measures
A 15-item survey.

Results
A total of 196 survey responses representing 300 units, majority general and single units, resulting in a 90.6% unit-level response rate. ICU unit characteristics included the average number of total, level 3 and level 2 critical care beds of 26.36 (SD=21.48), 15.67 (SD=15.33) and 10.96 (SD=8.86), respectively. Most units reported nurse to patient ratios compliant with national guidelines and service specifications. Post-COVID-19 changes to ICU nurse staffing establishments were reported by 44% respondents, including increases in non-registered staff. However, limited data were provided regarding decision-making around and changes to bedside allocation of nurses since COVID-19.

Conclusions
Increased numbers and use of non-registered staff within the ICU is indicative of an alternative staffing model to address nursing shortages. However, more research is needed to understand how this staffing group is being used compared with, and alongside, registered nurses.

Trial registration number
Clinicaltrials.gov: NCT05917574.

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Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal (UNIVERSAL) study: a prospective observational cohort study protocol

Background
Respiratory viral infections (RVIs) are a significant cause of morbidity and hospital admission worldwide. However, the management of most viral infection-associated diseases remains primarily supportive. The recent COVID-19 pandemic has underscored the urgent need for a deeper understanding of RVIs to improve patient outcomes and develop effective treatment strategies. The Understanding Infection, Viral Exacerbation and Respiratory Symptoms at Admission-Longitudinal Study is an observational study which addresses this need by investigating the heterogeneity of RVIs in hospitalised adults, aiming to identify clinical and biological predictors of adverse outcomes. This study aims to bridge critical knowledge gaps in the clinical course and the economic impact of RVIs by characterising the phenotypic diversity of these infections and their recovery patterns following hospital admission and thus assisting with the optimal design of future interventional studies.

Methods and analysis
This prospective longitudinal observational study (V.6, 20 September 2023) will be conducted across multiple UK secondary care sites from August 2022 onwards, with an aim to enrol 1000 participants testing positive for RVI. Adults admitted with respiratory symptoms who test positive for RVIs via the BioFire® FilmArray® System or other validated diagnostic PCR tests will be enrolled. The data collected include patient demographics, clinical history, comorbidities and symptoms experienced prior to, during and after hospitalisation with follow-up after discharge at weeks 1, 2, 4, 8, 12 and 26. In addition, biological samples are collected at multiple time points during the hospital stay. The primary endpoints are to study the impact of different RVIs and identify predictors of disease progression and length of stay. Secondary endpoints include time to recovery and healthcare cost. Exploratory endpoints focus on biomarker profiles associated with virus type and clinical outcomes.

Ethics and dissemination
The study protocol received ethical approval from the relevant committees (English Ethics Reference Number: 22/WM/0119; Scottish Ethics Reference Number: 22-SS-0101, 20/09/2023). For patients who lack the capacity to consent, the study complies with the Mental Capacity Act 2005, using a consultee process where a family member, carer or an independent clinician may provide assent on behalf of the patient. Data from all the study centres will be analysed together and disseminated through peer-reviewed journals, conference presentations and workshops. The study group will ensure that participants and their families are informed of the study findings promptly and in an accessible format.

Trial registration number
ISRCTN49183956.

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COVID-19 Early Detection in Doctors and Healthcare Workers (CEDiD) study: a cohort study on the feasibility of wearable devices

Background
Infectious agents such as SARS-CoV-2 require strategies to contain outbreaks, particularly in hospitals where the spread of infection is most likely. Biometric monitoring of heart rate, temperature, oxygen saturations and sleep might provide important early warning signs for SARS-CoV-2. This study aimed to determine whether a smart medical device (E4 wristband) and a pulse oximeter used to continuously measure heart rate, skin temperature and oxygen saturation would predict the onset of SARS-CoV-2 infection.

Methods
A single-centre, prospective observational cohort of 30 healthcare workers (HCWs) working in areas at high risk for exposure to SARS-CoV-2 were enrolled. HCWs were tested for SARS-CoV-2 using RT-qPCR of daily self-administered swabs for 30 days. Each participant was asked to wear an E4 wristband to measure changes in their heart rate, skin temperature and sleep throughout the study.

Results
Nine (30%) HCWs (median (range) age of 39 (27–57) years) tested positive for COVID-19. No significant differences were found in the pre-infection and post-infection variations in the heart rate (p=0.31) or skin temperature (p=0.44). Seven of the nine positive subjects reported symptoms at some point during the study period: unusual fatigue (40%), headache (33%) and runny nose (22%) were the most frequent. Analysis of daily trends in observations demonstrated significant fluctuations in biometric parameters.

Conclusion
These results suggest that wearable technology might be useful in documenting signs of SARS-CoV-2 infection in exposed HCWs.

Trial registration number
NCT04363489.

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Framework to guide the use of mathematical modelling in evidence-based policy decision-making

Introduction
The COVID-19 pandemic highlighted the significance of mathematical modelling in decision-making and the limited capacity in many low-income and middle-income countries (LMICs). Thus, we studied how modelling supported policy decision-making processes in LMICs during the pandemic (details in a separate paper).
We found that strong researcher–policymaker relationships and co-creation facilitated knowledge translation, while scepticism, political pressures and demand for quick outputs were barriers. We also noted that routine use of modelled evidence for decision-making requires sustained funding, capacity building for policy-facing modelling, robust data infrastructure and dedicated knowledge translation mechanisms.
These lessons helped us co-create a framework and policy roadmap for improving the routine use of modelling evidence in public health decision-making. This communication paper describes the framework components and provides an implementation approach and evidence for the recommendations. The components include (1) funding, (2) capacity building, (3) data infrastructure, (4) knowledge translation platforms and (5) a culture of evidence use.

Key arguments
Our framework integrates the supply (modellers) and demand (policymakers) sides and contextual factors that enable change. It is designed to be generic and disease-agnostic for any policy decision-making that modelling could support. It is not a decision-making tool but a guiding framework to help build capacity for evidence-based policy decision-making. The target audience is modellers and policymakers, but it could include other partners and implementers in public health decision-making.

Conclusion
The framework was created through engagements with policymakers and researchers and reflects their real-life experiences during the COVID-19 pandemic. Its purpose is to guide stakeholders, especially in lower-resourced settings, in building modelling capacity, prioritising efforts and creating an enabling environment for using models as part of the evidence base to inform public health decision-making. To validate its robustness and impact, further work is needed to implement and evaluate this framework in diverse settings.

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European Registry of Hereditary Pancreatic Diseases (EUROPAC): protocol for primary and secondary screening in individuals with inherited pancreatic disease syndromes for pancreatic ductal adenocarcinoma and complications of other pancreatic diseases

Introduction
Pancreatic cancer is a devastating disease and one of the top causes of cancer death worldwide. Over 30% of cases are potentially avoidable, and while screening for this disease should be possible, the current methods, without risk stratification to detect high-risk groups, are unlikely to detect these individuals. A tailored screening pathway could be applied to individuals with a germline genetic cause of pancreatic cancer, which may account for around 10% of cases.

Methods and analysis
EUROPAC, although having international reach, is described here in relation to the UK only. This national prospective observational study has run for several decades but was modified into the current trial in 2019, which aims to recruit and screen 10 000 individuals with either familial pancreatic cancer or hereditary pancreatitis (HP). Applicants are assessed for eligibility by generating an individual pedigree and by attributing a family risk score (FR). Individual risk is assessed according to age. Individuals over 40 with an FR >30 are offered baseline imaging and then three yearly triplets of annual endoscopic ultrasound (EUS) and an MRI (in the third year). Those with an FR >60 are offered both EUS and MRI yearly. HP patients are screened by CT and/or MRI dependent on risk stratification using the presence of diabetes, smoking or alcohol consumption. Low-risk (absence of these factors) patients have a CT every 2 years, and high-risk (one or more of the above factors) patients have alternate yearly screening with CT, then MRI. Biospecimens are collected at pragmatic intervals with first sampling at registration to support future biomarker development to detect pancreatic cancer early. Detection of early-stage pancreatic cancer and actionable lesions will be evaluated.

Ethics and dissemination
The EUROPAC study has been reviewed and approved by the Yorkshire and Humber Research Ethics Committee (Ref 19/YH/0250). Study results will be disseminated through national and international symposium presentations and published in peer-reviewed, open-access journals. All participants provided informed consent prior to entering the study.

Trial registration number
ISRCTN62546421

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Perceptions about chronic health conditions, multimorbidity and self-management practices in rural northeast South Africa: findings from a qualitative study

Introduction
Chronic health conditions are the leading causes of morbidity and mortality worldwide, with a disproportionately high burden in low-income and middle-income countries. The burden arising from these conditions presents immense challenges to countries with dysfunctional public healthcare systems, such as South Africa. This necessitates patients to have a good understanding of the conditions and optimal self-management approaches. We explored patients’ understanding of chronic health conditions and self-management practices, including self-monitoring, in the rural South African community of Agincourt in the subdistrict of Bushbuckridge, Mpumalanga Province.

Methods
We randomly selected patients receiving routine care for chronic health conditions in primary healthcare facilities who were linked to the Agincourt Health and Demographic Surveillance System to participate in focus group discussions. Six focus groups (three with men and three with women) were conducted, with 17 male and 19 female participants (n=35) living with different chronic health conditions. Data were collected using body mapping exercises and semistructured focus group discussions facilitated by two experienced qualitative research assistants. An inclusive thematic approach was used for analysis.

Results
Participants identified most chronic health conditions and their progression. Participants expressed that some consequences of chronic health conditions were unavoidable and some were attributed to medications. Three themes emerged on the management of chronic health conditions: (1) individual-level management, where participants actively changed or managed lifestyle factors associated with the conditions; (2) clinic-level management and support, where participants believed that following instructions from healthcare providers facilitates better management of their condition(s); and (3) prevention and screening, to prevent disease progression and development of complications. Participants also highlighted the role of religion in the control of chronic disease risk factors and traditional treatments for uncommon conditions such as epilepsy. Costs associated with lifestyle changes and equipment to manage and monitor health were highlighted as barriers to self-management of chronic health conditions.

Conclusions
Our findings contribute to emerging research on chronic health conditions and self-management approaches. Participants in our study demonstrated a good understanding of various chronic health conditions but lacked knowledge of self-management practices and faced barriers to self-management. There is a need for further studies on self-management of chronic health conditions, including self-monitoring among patients in rural sub-Saharan settings.

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How did the context of COVID-19 affect the implementation and mechanisms of participatory learning and action to address type 2 diabetes? Mixed-methods research in rural Bangladesh

Objectives
Research indicates the effectiveness of participatory interventions to address rapid rises in type 2 diabetes in low-income countries. Understanding their transferability to different contexts is a priority. We aimed to analyse how the COVID-19 post-lockdown context and adjustments to a participatory learning and action intervention affected theorised mechanisms of effect in rural Bangladesh and to examine the broader implications of this context and intervention adjustments for developing optimal contexts for participatory interventions.

Design
Mixed methods using longitudinal qualitative and quantitative observation data, focus group discussions and interviews with group and community members and project personnel. We used descriptive content analysis, guided by realist evaluation research questions about context, implementation and mechanisms. We used team reflection to enhance the rigour of our analysis.

Setting
Cluster-randomised trial in Alfadanga upazila, Faridpur district, in the central region of Bangladesh. The intervention was implemented between January 2020 and December 2022, during the COVID-19 pandemic.

Participants
Participatory group members, community members and project personnel (n=32). Structured observations of participatory groups (n=1820) and unstructured observations of groups and their environments (n=15).

Interventions
Participatory learning and action community groups of men and women implemented by community-based facilitators.

Results
Due to COVID-19, the participatory learning and action (PLA) intervention was not implemented as planned, which had major effects on the time available to develop the intervention with communities. Communities learnt about diabetes and were motivated to address its causes at an individual level, but community action was a more challenging mechanism to trigger. The post-pandemic context made it difficult to build community rapport, and strategies to engage communities through home visits were challenging. Communities’ prior negative experience in working together and in working with non-governmental organisations led to low community cohesion and low motivation to address diabetes collectively. This also resulted in expectations that the implementing organisation would implement community actions and incentivise attendance at meetings. This misalignment of expectations further disabled relationship building, and community strategies addressing the social causes of diabetes were largely not enacted.

Conclusion
PLA has optimal effects when time is available to build trust and social cohesion. These are contextual elements and mechanisms that need to be activated to enable critical reflection and community action to develop an enabling environment to address type 2 diabetes.

Trial registration number
ISRCTN42219712.

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Sensor-triggered ecological momentary assessment in physical activity and sedentary behaviour research among Belgian community-dwelling elderly: lessons learnt from intensive longitudinal studies

Objectives
Regular physical activity (PA) and reduced sedentary behaviour (SB) have been associated with positive health outcomes, but many older adults do not comply with the current recommendations. Sensor-triggered ecological momentary assessment (EMA) studies allow capturing real-time data during or immediately after PA or SB, which can yield important insights into these behaviours. Despite the promising potential of sensor-triggered EMA, this methodology is still in its infancy. Addressing methodological challenges in sensor-triggered EMA studies is essential for improving protocol adherence and enhancing validity. Therefore, this study aimed to examine (1) the patterns in sensor-triggered EMA protocol adherence (eg, compliance rates), (2) the impact of specific settings (eg, event duration) on the number of prompted surveys, and (3) participants’ experiences with engaging in a sensor-triggered EMA study.

Design
Two longitudinal, sensor-triggered EMA studies—one focused on PA and the other on SB—were conducted using similar methodologies from February to October 2022. Participants’ steps were monitored for seven days using a Fitbit activity tracker, which automatically prompted an EMA survey through the HealthReact smartphone application when specified (in)activity thresholds were reached. After the monitoring period, qualitative interviews were conducted. Data from both studies were merged.

Setting
The studies were conducted among community-dwelling Belgian older adults.

Participants
The participants had a median age of 72 years, with 54.17% being females. The PA study included 88 participants (four dropped out), while the SB study included 76 participants (seven dropped out).

Primary and secondary outcome measures
Descriptive methods and generalised logistic mixed models were employed to analyse EMA adherence patterns. Simulations were conducted to assess the impact of particular settings on the number of prompted EMA surveys. Additionally, qualitative interview data were transcribed verbatim and thematically analysed using NVivo.

Results
Participants responded to 81.22% and 79.10% of the EMA surveys in the PA and SB study, respectively. The confirmation rate, defined as the percentage of EMA surveys in which participants confirmed the detected behaviour, was 94.16% for PA and 72.40% for SB. Logistic mixed models revealed that with each additional day in the study, the odds of responding to the EMA survey increased significantly by 1.59 times (OR=1.59, 95% CI: 1.36 to 1.86, p

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Seroprevalence and demographic characteristics of SARS-CoV-2-infected residents of Kibera informal settlement during the COVID-19 pandemic in Nairobi, Kenya: a cross-sectional study

Objectives
To assess the prevalence of SARS-CoV-2 antibodies in the residents of Kibera informal settlement in Nairobi, Kenya, before vaccination became widespread, and explore demographic and health-related risk factors for infection.

Design
A cross-sectional study.

Setting
Kibera informal settlement, Nairobi, Kenya.

Participants
Residents of Kibera informal settlement between October 2019 and August 2021, age 1 year and above who reported no current symptoms of COVID-19.

Main outcome measures
Associations were determined between SARS-CoV-2 positive tests measured with one rapid test and two ELISAs and demographic and health-related factors, using Pearson’s 2 test. Crude OR and adjusted OR were calculated to quantify the strength of associations between variables and seropositive status.

Results
A total of 438 participants were recruited. Most (79.2%) were age 18–50 years; females (64.2%) exceeded males. More than one-third (39.1%) were unemployed; only 7.4% were in formal, full-time employment. Less than one-quarter (22.1%) self-reported any underlying health conditions. Nearly two-thirds (64.2%) reported symptoms compatible with COVID-19 in the previous 16 months; only one (0.23%) had been hospitalised with a reported negative COVID-19 test. 370 (84.5%) participants tested positive in any of the three tests. There was no significant difference in SARS-CoV-2 seropositivity across age, sex, presence of underlying health conditions, on medication or those ever tested for SARS-CoV-2. Multiple logistic regression analysis showed that COVID-19 symptoms in the previous 16 months were the only significant independent predictor of seropositivity (p=0.0085).

Conclusion
High SARS-CoV-2 exposure with limited morbidity was found in the residents of Kibera informal settlement. The study confirms other reports of high SARS-CoV-2 exposure with limited morbidity in slum communities. Reasons cited include the high infectious disease burden on the African continent, demographic age structure and underreporting due to limited testing and lack of access to healthcare services; genetic factors may also play a role. These factors require further investigation.

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Teens and opioids postsurgery (TOPS): protocol for a prospective observational study describing associations between sleep deficiency and opioid use following outpatient surgery in adolescents

Introduction
The opioid crisis is a significant burden on adolescent public health in the USA. Medical use of prescription opioids is a pathway via which adolescents transition to opioid misuse, opioid use disorder and overdose. More than half of all opioids prescribed to adolescents are for pain management following surgery. Yet, little is known about the critical period following surgery during which adolescents initiate opioid misuse or the modifiable mechanisms (such as sleep deficiency) contributing to this process. This prospective observational study will broaden our knowledge by examining associations between sleep deficiency and opioid use and misuse following surgery. We will also examine behavioural, psychological, family and social factors linking sleep deficiency with opioid use and misuse.

Methods and analysis
Adolescents (10–19 years) undergoing outpatient orthopaedic surgery, along with one parent, will be recruited from two paediatric hospitals, for a sample of 400 dyads. Adolescents will be assessed at six timepoints. Before surgery, participants will undergo comprehensive multimodal sleep assessments (sleep surveys and actigraphy). Participants will also report on previous substance use, pain intensity and psychosocial, family and social factors. Adolescents will then be closely monitored over the first 14 days following surgery using ecological momentary assessment methods to capture real-time, naturalistic, daily data on sleep, opioid use, pain and psychological factors (including mood, affect and subjective response to opioid use). Opioid use (total number of doses and duration) will be measured with an innovative electronic medication monitoring device following surgery. Follow-up assessments at 3 months, 6 months, 12 months and 24 months will track the development of opioid misuse over time. Our primary outcomes include opioid use during the immediate 14 days following surgery and the presence of opioid misuse at 24 months after surgery. Multilevel mediation models will determine associations between predictor variables and acute postsurgical opioid use. We will apply modern machine learning algorithms to develop and validate models predicting adolescent prescription opioid misuse at 24 months from surgery.

Ethics and dissemination
This study was approved by Advarra’s Center for Institutional Review Board Intelligence (CIRBI) (Protocol 00072049), which serves as the single IRB of record for this multisite study.

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Sexual and reproductive health knowledge, attitudes and practices among adolescents in rural Thatta, Pakistan: a cross-sectional study

Objectives
Adolescent Sexual and Reproductive Health encompasses their physical and emotional well-being, including their ability to avoid unwanted pregnancies, unsafe abortions, sexually transmitted infections (STIs) and any type of sexual violence and coercion. However, these risks may be mitigated through improved knowledge, encouraging positive attitudes, and adopting better practices. This study aimed to identify the factors associated with knowledge, attitudes and practices (KAP) related to HIV, STI, family planning and pregnancy among adolescents residing in rural Thatta.

Design
A cross-sectional study.

Setting
62 villages from Thatta, Gharo and Jungshahi registered under the Global Network Maternal and Newborn Health Registry in Thatta, Pakistan.

Participants
632 adolescents aged 14–19 years.

Outcome measures
The association between sociodemographic factors and KAP was assessed using a modified version of the ‘Asking Young People about Sexual and Reproductive Behaviors’ tool. Statistical analysis was performed on Stata V.15.0 using multiple linear regression.

Results
Among 632 adolescents, 82.7% were females. No significant differences were found in mean scores of knowledge and attitudes between males and females. However, a difference of 0.13 (95% CI 0.005, 0.24) in practice scores was observed. In design-based multivariable analysis, adolescents’ marital status (β 5.13; 95% CI 1.34, 8.91) and father’s occupation (β 3.41; 95% CI 0.90, 5.93) were associated with knowledge. Marital status (β 1.34; 95% CI 0.82, 1.86), household income (β –2.36; 95% CI –4.64, –0.07), father’s occupation (β –1.42; 95% CI –2.52, –0.33) and mother’s education (β –1.41; 95% CI –2.71, –0.11) were associated with attitudes. Moreover, marital status (β 0.24; 95% CI 0.06, 0.41) and mother’s occupation (β 0.64; 95% CI 0.38, 0.90) were associated with practices.

Conclusion
No differences in knowledge and attitudes between male and female adolescents were found. These findings suggest that community awareness programmes should be implemented to improve sexual and reproductive health KAP for both male and female adolescents in Thatta.

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