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AnteayerBMJ Open

Risk factors for SARS-CoV-2 infection: a test-negative case-control study with additional population controls in Norway

Por: Sarjomaa · M. · Zhang · C. · Tveten · Y. · Kersten · H. · Reiso · H. · Eikeland · R. · Kongerud · J. · Berg · K. K. · Thilesen · C. · Nordbo · S. A. · Aaberge · I. S. · Vandenbroucke · J. · Pearce · N. · Fell · A. K. M.
Objectives

This study aims to assess risk factors for SARS-CoV-2 infection by combined design; first comparing positive cases to negative controls as determined by PCR testing and then comparing these two groups to an additional prepandemic population control group.

Design and setting

Test-negative design (TND), multicentre case–control study with additional population controls in South-Eastern Norway.

Participants

Adults who underwent SARS-CoV-2 PCR testing between February and December 2020. PCR-positive cases, PCR-negative controls and additional age-matched population controls.

Primary outcome measures

The associations between various risk factors based on self- reported questionnaire and SARS-CoV-2 infection comparing PCR-positive cases and PCR-negative controls. Using subgroup analysis, the risk factors for both PCR-positive and PCR-negative participants were compared with a population control group.

Results

In total, 400 PCR-positive cases, 719 PCR-negative controls and 14 509 population controls were included. Male sex was associated with the risk of SARS-CoV-2 infection only in the TND study (OR 1.9, 95% CI 1.4 to 2.6), but not when PCR-positive cases were compared with population controls (OR 1.2, 95% CI 0.9. to 1.5). Some factors were positively (asthma, wood heating) or negatively (hypertension) associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but lacked convincing association in the TND study. Smoking was negatively associated with the risk of SARS-CoV-2 infection in both analyses (OR 0.5, 95% CI 0.3 to 0.8 and OR 0.6, 95% CI 0.4 to 0.8).

Conclusions

Male sex was a possible risk factor for SARS-CoV-2 infection only in the TND study, whereas smoking was negatively associated with SARS-CoV-2 infection in both the TND study and when using population controls. Several factors were associated with SARS-CoV-2 infection when PCR-positive cases were compared with population controls, but not in the TND study, highlighting the strength of combining case–control study designs during the pandemic.

Effectiveness of non-surgical management in rotator cuff calcific tendinopathy (the effect trial): protocol for a randomised clinical trial

Por: Caballero · I. · Duenas · L. · Balasch-Bernat · M. · Fernandez-Matias · R. · Breso-Parra · L. · Gallego-Terres · C. · Aroca Navarro · J. E. · Navarro-Bosch · M. · Lewis · J. · Lluch Girbes · E.
Introduction

Rotator cuff calcific tendinopathy (RCCT) involves calcific deposits in the rotator cuff. Non-surgical interventions such as extracorporeal shockwave therapy (ESWT) and ultrasound-guided percutaneous irrigation of calcific tendinopathy (US-PICT) are recommended for its early management. Exercise therapy (ET) has shown to be an effective intervention for people with rotator cuff tendinopathy, but it has not been formally tested in RCCT. The main objective of this study is to compare the effectiveness of an ET programme with ESWT and US-PICT in people with RCCT. As a secondary aim, this study aims to describe the natural history of RCCT.

Methods and analysis

A randomised, single-blinded four-group clinical trial will be conducted. Adults from 30 to 75 years diagnosed with RCCT who accomplish eligibility criteria will be recruited. Participants (n=116) will be randomised into four groups: ET group will receive a 12-week rehabilitation programme; ESWT group will receive four sessions with 1 week rest between sessions during 1 month; US-PICT group will receive two sessions with 3 months of rest between sessions; and (actual) wait-and-see group will not receive any intervention during the 12-month follow-up. The primary outcome will be shoulder pain assessed with the Shoulder Pain and Disability Index at baseline, 2 weeks, 4 months, 6 months and 12 months from baseline. The primary analysis will be performed at 12 months from baseline. Secondary outcomes will include pain, range of motion, patient satisfaction and imaging-related variables. Moreover, the following psychosocial questionnaires with their corresponding outcome measure will be assessed: Central Sensitization Inventory (symptoms related to central sensitization); Pain Catastrophizing Scale (pain catastrophizing); Tampa Scale for Kinesiophobia 11 items (fear of movement); Fear Avoidance Belief Questionnaire (fear avoidance behaviour); Hospital Anxiety and Depression Scale (anxiety and depression); Pittsburgh Sleep Quality Index (sleep quality); and the EuroQol-5D (quality of life). An intention-to-treat analysis will be performed to reduce the risk of bias using a worst-case and best-case scenario analysis.

Ethics and dissemination

Ethics committee approval for this study has been obtained (reference number: 1718862). The results of the main trial will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT05478902.

Use of oxygen-ozone therapy to improve the effectiveness of antibiotic treatment on infected arthroplasty: protocol for a superiority, open-label, multicentre, randomised, parallel trial

Por: Cascini · F. · Franzini · M. · Andreoli · A. · Manzotti · A. · Cadeddu · C. · Quaranta · G. · Gentili · A. · Ricciardi · W.
Introduction

Surgical site infections still remain a major public health challenge and have become an increasing universal risk, especially for the implantation of orthopaedic devices.

Unfortunately, the discovery and increasingly widespread use (especially the misuse) of antibiotics have led to the rapid appearance of antibiotic-resistant strains today; more and more infections are caused by microorganisms that fail to respond to conventional treatments.

Oxygen-ozone therapy has been extensively used and studied for decades across various potential medical applications and has provided consistent effects with minimal side effects.

This study aims to determine the superiority of oxygen-ozone therapy in combination with oral antibiotic therapy in patients with wound infections after an orthopaedic device implantation when compared with antibiotic therapy alone.

Methods and analysis

This is an open-label, multicentre, randomised, parallel-group study that aims to assess the efficacy and safety of oxygen-ozone therapy in combination with oral antibiotic therapy to treat infections in patients (male or female aged ≥18 years) having undergone surgery for the implant of an orthopaedic device. Patients must have at least one (but no more than three) postoperative wounds in the site of surgery (ulcers, eschars and sores) and at least one symptom (pain, burning, redness and malodour) and at least one sign (erythema, local warmth, swelling and purulent secretion) of infection of at least moderate intensity (score ≥2) in the target lesion at the screening visit (patients with wounds without signs of localised infection or with undermining wounds will be excluded).

Patients (n=186) will be recruited from five Italian hospitals and studied for 7 weeks. All will be assigned to one of the two treatment groups according to a web-based, centralised randomisation procedure and placed into either the (1) intervention: oxygen-ozone therapy 2–3 times a week for 6 weeks (for a maximum of 15 sessions) simultaneously with an appropriate oral antibiotic therapy prescribed at baseline or (2) control: oral antibiotic therapy prescribed at baseline.

The primary outcome is the efficacy and superiority of the treatment (ozone and oral antibiotic therapies); secondary outcomes include the resolution of signs and symptoms, modifications in lesion size and the treatment’s safety and tolerability.

Ethics and dissemination

This study has been reviewed and approved by the responsible Independent Ethics Committee (IEC) of COMITATO ETICO CAMPANIA NORD, located at ‘Azienda Ospedaliera San Giuseppe Moscati di Avellino’.

After completion of the study, the project coordinator will prepare a draft manuscript containing the final results of the study on the basis of the statistical analysis. The manuscript will be derived by the co-authors for comments, and after revision, it will be sent to a major scientific journal. Findings will be disseminated via online and print media, events and peer-reviewed journals.

Trial registration number

NCT04787575.

Service readiness for the management of non-communicable diseases in publicly financed facilities in Malawi: findings from the 2019 Harmonised Health Facility Assessment census survey

Por: Ahmed · S. · Cao · Y. · Wang · Z. · Coates · M. M. · Twea · P. · Ma · M. · Chiwanda Banda · J. · Wroe · E. · Bai · L. · Watkins · D. A. · Su · Y.
Introduction

Non-communicable diseases (NCDs) are rising in low-income and middle-income countries, including Malawi. To inform policy-makers and planners on the preparedness of the Malawian healthcare system to respond to NCDs, we estimated NCD service readiness in publicly financed healthcare facilities in Malawi.

Methods

We analysed data from 564 facilities surveyed in the 2019 Harmonised Health Facility Assessment, including 512 primary healthcare (PHC) and 52 secondary and tertiary care (STC) facilities. To characterise service readiness, applying the law of minimum, we estimated the percentage of facilities with functional equipment and unexpired medicines required to provide NCD services. Further, we estimated permanently unavailable items to identify service readiness bottlenecks.

Results

Fewer than 40% of PHC facilities were ready to deliver services for each of the 14 NCDs analysed. Insulin and beclomethasone inhalers had the lowest stock levels at PHC facilities (6% and 8%, respectively). Only 17% of rural and community hospitals (RCHs) have liver and kidney diagnostics. STC facilities had varying service readiness, ranging from 27% for managing acute diabetes complications to 94% for chronic type 2 diabetes management. Only 38% of STC facilities were ready to manage chronic heart failure. Oral pain medicines were widely available at all levels of health facilities; however, only 22% of RCHs and 29% of STCs had injectable morphine or pethidine. Beclomethasone was never available at 74% of PHC and 29% of STC facilities.

Conclusion

Publicly financed facilities in Malawi are generally unprepared to provide NCD services, especially at the PHC level. Targeted investments in PHC can substantially improve service readiness for chronic NCD conditions in local communities and enable STC to respond to acute NCD complications and more complex NCD cases.

Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial

Por: Matias-Guiu · J. A. · Gonzalez-Rosa · J. · Hernandez · M. A. · Martinez-Gines · M. L. · Portoles · A. · Perez-Macias · N. · Benito-Leon · J. · Padron · I. · Prieto · J. · Matias-Guiu · J.
Introduction

Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations. We aim to investigate the effect of 6 weeks of amantadine and/or TMS in fatigue due to MS.

Methods and analysis

The study is a national, multicentre, phase 3, randomised, double-blind, cross-over, placebo-controlled and sham-controlled clinical trial. Adult patients with relapsing-remitting MS, Expanded Disability Status Scale score of 1.5–4.5 and Fatigue Severity Score>4 are eligible for the trial. Participants will be randomised to one of the sequences of the study. Each sequence consists of four periods of 6 weeks of treatment and three washout periods of 12–18 weeks. All patients will receive all the combinations of therapies. The primary outcome is the Modified Fatigue Impact Scale. The secondary outcomes are the Symbol Digit Modalities Test (cognition), Beck Depression Inventory-II (depressive symptoms) and Short-Survey 12 (quality of life). Safety and cost-effectiveness will also be evaluated. An exploratory substudy including MRI and blood biomarkers will be conducted.

Ethics and dissemination

The study is approved by the Ethics Committee of the Hospital Clinico San Carlos and the Spanish Agency of Medications and Medical Devices. All study findings will be published in scientific peer-reviewed journals and presented at relevant scientific conferences.

Trial registration number

EudraCT 2021-004868-95; NCT05809414.

Prevalence and short-term change in symptoms of anxiety and depression following bariatric surgery: a prospective cohort study

Objectives

Bariatric surgery is an effective treatment for severe obesity that leads to significant physical health improvements. Few studies have prospectively described the short-term impact of surgery on mental health using standardised case-finding measures for anxiety or depressive disorders. This study describes the prevalence and short-term course of these conditions following surgery.

Design

Prospective observational cohort study.

Setting

12 National Health Service centres in England.

Participants

Participants studied took part in the By-Band-Sleeve study, a multicentre randomised controlled trial evaluating the surgical management of severe obesity. We included participants who had undergone surgery (gastric bypass, gastric band or sleeve gastrectomy) within 6 months of randomisation.

Primary and secondary outcome measures

Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS) at baseline and 12 months post-randomisation. Sociodemographic variables collected at prerandomisation included body mass index, age, sex, ethnicity, marital status, tobacco use, employment status and income band.

Results

In our sample of 758 participants, 94.5% (n 716) and 93.9% (n 712) had completed baseline anxiety (HADS-A) and depression (HADS-D) subscales. At pre-randomisation 46.1% (n 330/716, 95% CI 42.4% to 49.7%) met clinical case criteria for anxiety and 48.2% (n 343/712, 95% CI 44.5% to 51.8%) for depression. Among participants returning completed 12 months post-randomisation questionnaires (HADS-A n 503/716, HADS-D n 498/712), there was a significant reduction in the proportion of clinical cases with anxiety (–9.5%, 95% CI –14.3% to -4.8% p

Conclusions

Almost half of people undergoing bariatric surgery had underlying anxiety or depressive symptoms. In the short term, these symptoms appear to substantially improve. Future work must identify whether these effects are sustained beyond the first post-randomisation year.

Trial registration number

NCT02841527 and ISRCTN00786323.

Experimental studies testing interventions to promote cultural safety, interculturality or antiracism in healthcare: protocol for a systematic review

Por: Sarmiento · I. · Rojas-Cardenas · A. · Zuluaga · G. · Belaid · L. · Cockcroft · A. · Andersson · N.
Introduction

Cultural safety, interculturality and antiracism are crucial concepts in addressing health disparities of minority and diverse groups. Measuring them is challenging, however, due to overlapping meanings and their highly contextual nature. Community engagement is essential for evaluating these concepts, yet the methods for social inclusion and protocols for participation remain unclear. This review identifies experimental studies that measure changes resulting from culturally safe, intercultural or antiracist healthcare. The review will describe outcomes and additional factors addressed in these studies.

Methods and analysis

The study focuses on epidemiological experiments with counterfactual comparisons and explicit interventions involving culturally safe, intercultural or antiracist healthcare. The search strategy covers PubMed, CINAHL, Scopus, Web of Science, ProQuest, LILACS and WHO IRIS databases. We will use critical appraisal tools from the Joanna Briggs Institute to assess the quality of randomised and non-randomised experimental studies. Two researchers will screen references, select studies and extract data to summarise the main characteristics of the studies, their approach to the three concepts under study and the reported effect measures. We will use fuzzy cognitive mapping models based on the causal relationships reported in the literature. We will consider the strength of the relationships depicted in the maps as a function of the effect measure reported in the study. Measures of centrality will identify factors with higher contributions to the outcomes of interest. Illustrative intervention modelling will use what-if scenarios based on the maps.

Ethics and dissemination

This review of published literature does not require ethical approval. We will publish the results in a peer-reviewed journal and present them at conferences. The maps emerging from the process will serve as evidence-based models to facilitate discussions with Indigenous communities to further the dialogue on the contributing factors and assessment of cultural safety, interculturality and antiracism.

PROSPERO registration number

CRD42023418459.

Social and clinical vulnerability in stroke and STEMI management during the COVID-19 pandemic: a registry-based study

Por: Lesaine · E. · Francis · F. · Domecq · S. · Miganeh-Hadi · S. · Sevin · F. · Sibon · I. · Rouanet · F. · Pradeau · C. · Coste · P. · Cetran · L. · Vandentorren · S. · Saillour · F. · AVICOVID group · Faucheux · Leca Radu · Seignolles · Chazalon · Dan · Lucas · Peron · Wong-So · Martinez
Objective

This study aims to evaluate whether the first wave of the COVID-19 pandemic resulted in a deterioration in the quality of care for socially and/or clinically vulnerable stroke and ST-segment elevation myocardial infarction (STEMI) patients.

Design

Two cohorts of STEMI and stroke patients in the Aquitaine neurocardiovascular registry.

Setting

Six emergency medical services, 30 emergency units, 14 hospitalisation units and 11 catheterisation laboratories in the Aquitaine region in France.

Participants

This study involved 9218 patients (6436 stroke and 2782 STEMI patients) in the neurocardiovascular registry from January 2019 to August 2020.

Primary outcome measures

Care management times in both cohorts: first medical contact-to-procedure time for the STEMI cohort and emergency unit admission-to-imaging time for the stroke cohort. Associations between social (deprivation index) and clinical (age >65 years, neurocardiovascular history) vulnerabilities and care management times were analysed using multivariate linear mixed models, with an interaction on the time period (pre-wave, per-wave and post-first COVID-19 wave).

Results

The first medical contact procedure time was longer for elderly (p

Conclusions

This study revealed pre-existing inequalities in care management times for vulnerable STEMI and stroke patients; however, these inequalities were neither accentuated nor reduced during the first COVID-19 wave. Measures implemented during the crisis did not alter the structured emergency pathway for these patients.

Trial registration number

NCT04979208

Assessment of quality of life for frail, elderly patients post-ICU discharge: a protocol for a scoping review

Por: Kjaergaard-Andersen · G. · Bauer · E. H. · Bhavsar · R. P. · Jensen · H. I. · Ahrenfeldt · L. J. · Hvidt · N. C. · Stroem · T.
Introduction

Rises in average life expectancy, increased comorbidities and frailty among older patients lead to higher admission rates to intensive care units (ICU). During an ICU stay, loss of physical and cognitive functions may occur, causing prolonged rehabilitation. Some functions may be lost permanently, affecting quality of life (QoL). There is a lack of understanding regarding how many variables are relevant to health-related outcomes and which outcomes are significant for the QoL of frail, elderly patients following discharge from the ICU. Therefore, this scoping review aims to identify reported variables for health-related outcomes and explore perspectives regarding QoL for this patient group.

Methods and analysis

The Joanna Briggs Institute guidelines for scoping reviews will be employed and original, peer-reviewed studies in English and Scandinavian languages published from 2013 to 2023 will be included. The search will be conducted from July 2023 to December 2023, according to the inclusion criteria in Embase, MEDLINE, PsycINFO and CINAHL. References to identified studies will be hand-searched, along with backward and forward citation searching for systematic reviews. A librarian will support and qualify the search strategy. Two reviewers will independently screen eligible studies and perform data extraction according to predefined headings. In the event of disagreements, a third reviewer will adjudicate until consensus is achieved. Results will be presented narratively and in table form and discussed in relation to relevant literature.

Ethics and dissemination

Ethical approval is unnecessary, as the review synthesises existing research. The results will be disseminated through a peer-reviewed publication in a scientific journal.

Distribution of intranasal naloxone to potential opioid overdose bystanders in Sweden: effects on overdose mortality in a full region-wide study

Por: Hakansson · A. · Alanko Blome · M. · Isendahl · P. · Landgren · M. · Malmqvist · U. · Troberg · K.
Objectives

Distribution of take-home naloxone is suggested to reduce opioid-related fatalities, but few studies have examined the effects on overdose deaths in the general population of an entire community. This study aimed to assess the effects on overdose deaths of a large-scale take-home naloxone programme starting in June 2018, using an observational design with a historic control period.

Design

From the national causes of death register, deaths diagnosed as X42 or Y12 (International Classification of Diseases, 10th revision, ICD-10) were registered as overdoses. Numbers of overdoses were calculated per 100 000 inhabitants in the general population, and controlled for data including only individuals with a prior substance use disorder in national patient registers, to focus on effects within the primary target population of the programme. The full intervention period (2019–2021) was compared with a historic control period (2013–2017).

Setting

Skåne county, Sweden.

Participants

General population.

Interventions

Large-scale take-home naloxone distribution to individuals at risk of overdose.

Primary and secondary outcome measures

Decrease in overdose deaths per 100 000 inhabitants, in total and within the population with substance use disorder diagnosis.

Results

Annual average number of overdose deaths decreased significantly from 3.9 to 2.8 per 100 000 inhabitants from the control period to the intervention period (a significant decrease in men, from 6.7 to 4.3, but not in women, from 1.2 to 1.3). Significant changes remained when examining only prior substance use disorder patients, and decreases in overdose deaths could not be attributed to a change in treatment needs for opioid use disorders in healthcare and social services.

Conclusions

The present study, involving 3 years of take-home naloxone distribution, demonstrated a decreased overdose mortality in the population, however, only in men. The findings call for further implementation of naloxone programmes, and for further studies of potential effects and barriers in women.

Trial registration number

NCT03570099.

Differences in health literacy related to gestational weight gain and childrens birth weight according to maternal nativity status in the Japan Environment and Childrens Study (JECS): a longitudinal cohort study

Por: Kigawa · M. · Tsuchida · A. · Matsumura · K. · Ito · M. · Tanaka · T. · Hamazaki · K. · Adachi · Y. · Inadera · H. · The Japan Environment and Childrens Study (JECS) Group · Kamijima · Yamazaki · Ohya · Kishi · Yaegashi · Hashimoto · Mori · Ito · Yamagata · Nakayama · Sobue · Shima
Objectives

We examined literacy related to healthy gestational weight gain (GWG) in immigrant and native Japanese mothers and determined whether it is associated with children’s birth weight.

Design

Longitudinal cohort study.

Setting

As the baseline survey in the Japan Environment and Children’s Study (JECS), mothers completed self-administered questionnaires distributed by hand during pregnancy. The self-administered questionnaires used in this study were distributed by mail 6 months after delivery. Children’s birth weight, actual GWG and any complications during delivery were recorded by obstetricians collaborating with JECS.

Participants

Of 97 452 mothers who consented to participate in the JECS during pregnancy between January 2011 and March 2014, 67 953 were included in this study after exclusions for multiple births, multiple instances of consent by the same pregnant woman, miscarriages/stillbirths or withdrawal from the study within 3 years after participating. In total, 324 immigrant mothers and 963 native Japanese mothers were selected by propensity score matching for analysis.

Primary and secondary outcome measures

Data were collected on maternal literacy related to healthy GWG at the baseline survey, and data on actual GWG and children’s birth weight were collected by obstetricians. The associations of knowledge about healthy GWG and mothers’ actual GWG with maternal nativity status were examined using a 2 or Student’s t-test.

Results

More native Japanese mothers than immigrant mothers knew the appropriate GWG and reason the for needing to know this. Actual GWG was significantly higher among the immigrant mothers, but was within the recommended range. The low birthweight (LBW) incidence was significantly higher among the native mothers.

Conclusions

Immigrant mothers to Japan had less knowledge about appropriate GWG, but their actual GWG was appropriate and they delivered fewer LBW infants than native Japanese mothers. These findings may indicate the presence of other protective factors for pregnancy or delivery among immigrant mothers.

How can community pharmacists be supported to manage skin conditions? A multistage stakeholder research prioritisation exercise

Por: Harvey · J. · Shariff · Z. · Anderson · C. · Boyd · M. J. · Ridd · M. J. · Santer · M. · Thomas · K. S. · Maidment · I. · Leighton · P.
Objective

To establish research priorities which will support the development and delivery of community pharmacy initiatives for the management of skin conditions.

Design

An iterative, multistage stakeholder consultation consisting of online survey, participant workshops and prioritisation meeting.

Setting

All data collection took place online with participants completing a survey (delivered via the JISC Online Survey platform, between July 2021 and January 2022) and participating in online workshops and meetings (hosted on Microsoft Teams between April and July 2022).

Participants

174 community pharmacists and pharmacy staff completed the online survey.

53 participants participated in the exploratory workshops (19 community pharmacists, 4 non-pharmacist members of pharmacy staff and 30 members of the public). 4 healthcare professionals who were unable to attend a workshop participated in a one-to-one interview.

29 participants from the workshops took part in the prioritisation meeting (5 pharmacists/pharmacy staff, 1 other healthcare professional and 23 members of the public).

Results

Five broad areas of potential research need were identified in the online survey: (1) identifying and diagnosing skin conditions; (2) skin conditions in skin of colour; (3) when to refer skin conditions; (4) disease-specific concerns and (5) product-specific concerns.

These were explored and refined in the workshops to establish 10 potential areas for research, which will support pharmacists in managing skin conditions. These were ranked in the prioritisation meeting. Among those prioritised were topics which consider how pharmacists work with other healthcare professionals to identify and manage skin conditions.

Conclusions

Survey responses and stakeholder workshops all recognised the potential for community pharmacists to play an active role in the management of common skin conditions. Future research may support this in the generation of resources for pharmacists, in encouraging public take-up of pharmacy services, and in evaluating the most effective provision for dealing with skin conditions.

All-cause and cause-specific mortality among individuals imprisoned for driving under the influence of alcohol and drugs in Norway (2000-2016): a retrospective cohort study

Por: Jamt · R. E. G. · Bukten · A. · Stavseth · M. R. · Bogstrand · S. T. · Tverborgvik · T.
Aims

To describe all-cause and cause-specific mortality and to investigate factors associated with mortality among individuals imprisoned for driving under the influence (DUI) of alcohol and psychoactive drugs in the Norwegian prison population.

Design

Retrospective cohort study. The Norwegian prison registry was linked to the Norwegian Cause of Death Registry (2000–2016).

Setting

Norway.

Participants/cases

The cohort consisted of 96 856 individuals imprisoned in Norway over a 17-year period obtained from the Norwegian prison registry.

Primary and secondary outcome measures

Adjusted ORs (aOR) with 95% CI were calculated for death due to any, natural and unnatural causes of death. Analyses were stratified according to DUI convictions: no DUI convictions, only DUI convictions (DUI only), DUI and at least one other drug and alcohol conviction (DUI drug), and DUI and at least one conviction other than drug and alcohol conviction (DUI other).

Results

In total, 29.3% individuals had one or more imprisonments for DUI. The risk of all-cause mortality was elevated for those convicted for DUI, but only in combination with other types of crimes (DUI drug: aOR=1.5, 95% CI 1.4 to 1.6, DUI other: aOR=1.2, 95% CI 1.1 to 1.4). The risk of death from natural causes was significantly elevated for DUI drug (aOR: 1.8, 95% CI 1.6 to 2.0) and for DUI other (aOR=1.3, 95% CI 1.1 to 1.6). The risk of death from unnatural causes was lower for DUI only (aOR=0.8, 95% CI 0.7 to 0.9) and elevated for DUI drug (aOR=1.5, 95% CI 1.3 to 1.6).

Conclusions

The risk of all-cause mortality was significantly elevated for those convicted of DUI, but only in combination with other types of crimes.

Does Health & Her app use improve menopausal symptoms? A longitudinal cohort study

Por: Andrews · R. · Lancastle · D. · Bache · K. · Lacey · A. S.
Objectives

The Health & Her app provides menopausal women with a means of monitoring their symptoms, symptom triggers and menstrual periods, and enables them to engage in a variety of digital activities designed to promote well-being. This study aimed to examine whether sustained weekly engagement with the app is associated with improvements in menopausal symptoms.

Design

A pre–post longitudinal cohort study.

Setting

Analysed data collected from Health & Her app users.

Participants

1900 women who provided symptom data via the app across a 2-month period.

Primary and secondary outcome measures

Symptom changes from baseline to 2 months was the outcome measure. A linear mixed effects model explored whether levels of weekly app engagement influenced symptom changes. Secondary analyses explored whether app-usage factors such as total number of days spent logging symptoms, reporting triggers, reporting menstrual periods and using in-app activities were independently predictive of symptom changes from baseline. Covariates included hormone replacement therapy use, hormonal contraceptive use, present comorbidities, age and dietary supplement use.

Results

Findings demonstrated that greater engagement with the Health & Her app for 2 months was associated with greater reductions in symptoms over time. Daily use of in-app activities and logging symptoms and menstrual periods were each independently associated with symptom reductions.

Conclusions

This study demonstrated that greater weekly engagement with the app was associated with greater reductions in symptoms. It is recommended that women be made aware of menopause-specific apps, such as that provided by Health & Her, to support them to manage their symptoms.

Correlational study of ergonomic knowledge and level of MSK discomfort during online classes of 1st-4th year UST-CRS physical therapy students: a cross-sectional study

Por: Siy · W. · Sicat · Z. M. · Bautista · T. M. · Formalejo · A. · Gatdula · M. E. · Ico · A. A. · Julian · C. J. · Pabion · M. C. · Reyes · J. L. · Santander · N. M.
Introduction

The abrupt transition of the mode of learning due to the COVID-19 pandemic resulted in an increase in complaints of musculoskeletal (MSK) discomfort among students in Higher Education Institutions (HEI). Inadequate physical space and equipment are one major cause of these complaints. Among HEIs, physical therapy (PT) students have sufficient background in managing MSK discomforts. However, this does not prevent them from experiencing pain and discomfort during online classes. This analytical cross-sectional study aims to determine the correlation between ergonomic knowledge and MSK discomfort among first-year to fourth-year PT students.

Methods and analysis

The study will use two questionnaires, the Ergonomic Knowledge Questionnaire, and the Cornell Musculoskeletal Discomfort Questionnaire, that determine the level of ergonomic knowledge and MSK discomfort, respectively. This will be disseminated to 144 students through google forms. Results will then be analysed using Pearson Correlation Test. The study anticipates a correlation between the level of ergonomic knowledge and MSK discomfort among the participants.

Ethics and dissemination

The study has been approved by the University of Santo Tomas-College of Rehabilitation Sciences Ethics Review Committee. The participants will receive the results prior to publication in a peer-reviewed scientific journal.

Trial registration number

Philippine Health Research Registry with registry ID PHRR230216-005443.

Individual and community-level risk factors for maternal morbidity and mortality among Native American women in the USA: protocol for systematic review

Por: Celaya · M. F. · Madhivanan · P. · McClelland · J. · Zahlan · A. · Rock · C. · Nathan · A. · Acharya · A.
Introduction

Incidents of maternal morbidity and mortality (MMM) continue to rise in the USA. Significant racial and ethnic health inequities exist, with Native American (NA) women being three to four times more likely to die than white, non-Hispanic women, and three to five times more likely to experience an incident of severe maternal morbidity. Few studies have identified individual and community-level risk factors of MMM experienced by NA women. Therefore, this systematic review will identify said risk factors of MMM experienced by NA women in the USA.

Methods and analysis

This systematic review will be conducted according to the Cochrane Handbook for Systematic Reviews, and the findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA). The search strategy will include searches from electronic databases: PUBMED, EMBASE, CINAHL and SCOPUS, from 1 January 2012 to 10 October 2022. The search strategy will include terms related to the search concepts: ‘maternal’, ‘Native American’ and ‘MMM’. Bibliographies of selected articles, previously published reviews and high-yield journals will also be searched. All included papers will be evaluated for quality and bias using NIH Quality Assessment Tools for Observational Studies. A description of the study findings will be presented in a tabular format organised by outcome of interest along with study characteristics.

Ethics and dissemination

There are no formal ethics approvals needed for this protocol. The findings of this systematic review will be shared with academic, governmental, community-based, institutes and NA (tribal) entities via a published peer-reviewed article, informational brief, poster and oral presentations.

PROSPERO registration number

CRD42022363405.

Use of Artificial Intelligence in the Identification and Management of Frailty: A Scoping Review Protocol

Por: Karunananthan · S. · Rahgozar · A. · Hakimjavadi · R. · Yan · H. · Dalsania · K. A. · Bergman · H. · Ghose · B. · LaPlante · J. · McCutcheon · T. · McIsaac · D. I. · Abbasgholizadeh Rahimi · S. · Sourial · N. · Thandi · M. · Wong · S. T. · Liddy · C.
Introduction

Rapid population ageing and associated health issues such as frailty are a growing public health concern. While early identification and management of frailty may limit adverse health outcomes, the complex presentations of frailty pose challenges for clinicians. Artificial intelligence (AI) has emerged as a potential solution to support the early identification and management of frailty. In order to provide a comprehensive overview of current evidence regarding the development and use of AI technologies including machine learning and deep learning for the identification and management of frailty, this protocol outlines a scoping review aiming to identify and present available information in this area. Specifically, this protocol describes a review that will focus on the clinical tools and frameworks used to assess frailty, the outcomes that have been evaluated and the involvement of knowledge users in the development, implementation and evaluation of AI methods and tools for frailty care in clinical settings.

Methods and analysis

This scoping review protocol details a systematic search of eight major academic databases, including Medline, Embase, PsycInfo, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Ageline, Web of Science, Scopus and Institute of Electrical and Electronics Engineers (IEEE) Xplore using the framework developed by Arksey and O’Malley and enhanced by Levac et al and the Joanna Briggs Institute. The search strategy has been designed in consultation with a librarian. Two independent reviewers will screen titles and abstracts, followed by full texts, for eligibility and then chart the data using a piloted data charting form. Results will be collated and presented through a narrative summary, tables and figures.

Ethics and dissemination

Since this study is based on publicly available information, ethics approval is not required. Findings will be communicated with healthcare providers, caregivers, patients and research and health programme funders through peer-reviewed publications, presentations and an infographic.

Registration details

OSF Registries (https://doi.org/10.17605/OSF.IO/T54G8).

Analysis of cardiovascular risk factors for the viability of cornea donors: a case-control study

Objective

The main objective of the study was to evaluate the influence of arterial hypertension, diabetes, dyslipidaemia, smoking, alcoholism and COPD (chronic obstructive pulmonary disease) on the viability of the extracted tissue as well as the donor.

Design

Observational case–control study.

Setting

Regional hospital in Northern Spain.

Participants

1517 corneas were registered.

Interventions

Patients’ medical history was reviewed after corneal donation and evaluation. Previous medical information (age, sex and cardiovascular risk factors (CVRFs)) and data related to the donor (type of donor), the corneal tissue and its evaluation, and the viability of the implant were collected.

Results

A total of 1517 corneas were registered and 81.5% of the donors presented at least one CVRF. In relation to the viability of the donor, it was observed that having suffered from COPD reduced the viability of the donor (no COPD: 93.8% vs COPD: 88%; OR=0.49; 95% CI: 0.28 to 0.84) while alcohol consumption increased it (drinker or ex-drinker: 95.8% vs non-drinker: 92.5%; OR=1.84; 95% CI: 1.01 to 3.33). Regarding tissue viability, decreased viability was observed in the presence of COPD (no COPD: 72.5% vs COPD: 64; OR=0.67; 95% CI: 0.47 to 0.96) and diabetes mellitus (no diabetes: 72.9% vs diabetes: 67.2%; OR=0.76; 95% CI: 0.58 to 0.99). As regards the viability of the implant, a total of 1039 corneas (68.9%) were suitable, observing decreased viability when suffering from COPD (no COPD: 69.8% vs COPD: 60.7%; OR=0.67; 95% CI: 0.47 to 0.94) and increased when having an active smoking habit (no habit: 65.3% vs habit: 74.1%; OR=1.52; 95% CI: 1.21 to 1.91).

Conclusions

Through this study, it can be concluded that in the absence of absolute exclusion criteria for donors, the assessment of how CVRF, alcoholism and COPD may affect the donor provides details about the quality of the tissue to be obtained.

Efficacy of cell-based immunotherapies on patients with glioma: an umbrella review of systematic reviews and meta-analysis protocol

Por: Nikoobakht · M. · Shamshiripour · P. · Mostafavi Zadeh · S. M. · Rahnama · M. · Hajiahmadi · F. · Ramezani · A. · Farzam Rad · V. · Nazari · E. · Moradi · A.-R. · Akbarpour · M. · Ahmadvand · D.
Introduction

Glial brain tumours are highly mortal and are noted as major neurosurgical challenges due to frequent recurrence or progression. Despite standard-of-care treatment for gliomas, the prognosis of patients with higher-grade glial tumours is still poor, and hence empowering antitumour immunity against glioma is a potential future oncological prospect. This review is designed to improve our understanding of the efficacy of cell-based immunotherapies for glioma.

Methods and analysis

This systematic review will be performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. A comprehensive search of main electronic databases: PubMed/MEDLINE, Scopus, ISI Web of Science EMBASE and ProQuest will be done on original articles, followed by a manual review of review articles. Only records in English and only clinical trials will be encountered for full-text review. All the appropriate studies that encountered the inclusion criteria will be screened, selected and then will undergo data extraction step by two independent authors. For meta-analyses, data heterogeneity for each parameter will be first evaluated by Cochran’s Q and I2 statistics. In case of possible heterogeneity, a random-effects meta-analysis will be performed and for homogenous data, fixed-effects models will be selected for reporting the results of the proportional meta-analysis. Bias risk will be assessed through Begg’s and Egger’s tests and will also be visualised by Funnel plots.

Ethics and dissemination

As this study will be a systematic review without human participants’ involvement, no ethical registration is required and meta-analysis will be presented at a peer-reviewed journal.

PROSPERO registration number

CRD42022373297

Country adoption of WHO 2019 guidance on HIV testing strategies and algorithms: a policy review across the WHO African region

Por: Fajardo · E. · Lastrucci · C. · Bah · N. · Mingiedi · C. M. · Ba · N. S. · Mosha · F. · Lule · F. J. · Paul · M. A. S. · Hughes · L. · Barr-DiChiara · M. · Jamil · M. S. · Sands · A. · Baggaley · R. · Johnson · C.
Objectives

In 2019, the WHO released guidelines on HIV testing service (HTS). We aim to assess the adoption of six of these recommendations on HIV testing strategies among African countries.

Design

Policy review.

Setting

47 countries within the WHO African region.

Participants

National HTS policies from the WHO African region as of December 2021.

Primary and secondary outcome measures: Uptake of WHO recommendations across national HTS policies including the standard three-test strategy; discontinuation of a tiebreaker test to rule in HIV infection; discontinuation of western blotting (WB) for HIV diagnosis; retesting prior to antiretroviral treatment (ART) initiation and the use of dual HIV/syphilis rapid diagnostic tests (RDTs) in antenatal care. Country policy adoption was assessed on a continuum, based on varying levels of complete adoption.

Results

National policies were reviewed for 96% (n=45/47) of countries in the WHO African region, 38% (n=18) were published before 2019 and 60% (n=28) adopted WHO guidance. Among countries that had not fully adopted WHO guidance, not yet adopting a three-test strategy was the most common reason for misalignment (45%, 21/47); of which 31% and 22% were in low-prevalence (

Conclusions

Many countries in the African region have adopted WHO-recommended HIV testing strategies; however, efforts are still needed to fully adopt WHO guidance. Countries should accelerate their efforts to adopt and implement a three-test strategy, retesting prior to ART initiation and the use of dual HIV/syphilis RDTs.

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