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Evaluation of antimicrobial photodynamic therapy and minimal intervention associated with deproteinisation in permanent teeth with molar incisor hypomineralisation: study protocol for a clinical, controlled, blinded trial

Por: Mandetta · A. R. H. · Bortoletto · C. C. · Sobral · A. P. T. · Goncalves · M. L. L. · Motta · L. J. · Horliana · A. C. R. T. · Ferrari · R. A. M. · Prates · R. A. · Deana · A. M. · Cordeiro · R. d. C. L. · Pinto · L. A. M. d. S. · Fernandes · K. P. S. · Bussadori · S. K.
Introduction

Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.

Methods and analysis

Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical–mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the 2 test or Fisher’s exact test. Pearson’s correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.

Ethics and dissemination

This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.

Trial registration number

NCT05443035.

Investigating Scottish Long COVID community rehabilitation service models from the perspectives of people living with Long COVID and healthcare professionals: a qualitative descriptive study

Por: Duncan · E. · Alexander · L. · Cowie · J. · Love · A. · Morris · J. H. · Moss · R. · Ormerod · J. · Preston · J. · Shim · J. · Stage · E. · Tooman · T. · Cooper · K.
Objectives

This study aimed to explore the perceptions and experiences of barriers and facilitators to accessing Long COVID community rehabilitation.

Design

We used a qualitative descriptive design over two rounds of data collection with three participant groups: (1) people with experience of rehabilitation for Long COVID (PwLC); (2) National Health Service (NHS) staff delivering and/or managing community rehabilitation services (allied health professionals (AHPs)) and (3) NHS staff involved in strategic planning around Long COVID in their health board (Long COVID leads).

Setting

Four NHS Scotland territorial health boards.

Participants

51 interviews: eight Long COVID leads (11 interviews); 15 AHPs (25 interviews) and 15 PwLC (15 interviews).

Results

Three key themes were identified: (1) accessing care for PwLC, (2) understanding Long COVID and its management and (3) strengths and limitations of existing Long COVID rehabilitation services.

Conclusions

Organisational delivery of Long COVID community rehabilitation is complex and presents multiple challenges. In addition, access to Long COVID community rehabilitation can be challenging. When accessed, these services are valued by PwLC but require adequate planning, publicity and resource. The findings presented here can be used by those developing and delivering services for people with Long COVID.

Inhaled beclomethasone in the treatment of early COVID-19: a double-blind, placebo-controlled, randomised, hospital-based trial in Sri Lanka

Por: Mettananda · C. · Peiris · C. · Abeyrathna · D. · Gunasekara · A. · Egodage · T. · Dantanarayana · C. · Pathmeswaran · A. · Ranasinha · C.
Objectives

To study if early initiation of inhaled beclomethasone 1200 mcg in patients with asymptomatic, mild or moderate COVID-19 reduces disease progression to severe COVID-19.

Design

Double-blinded, parallel-groups, randomised, placebo-controlled trial.

Setting

A hospital-based study in Sri Lanka.

Participants

Adults with asymptomatic, mild or moderate COVID-19, presenting within the first 7 days of symptom onset or laboratory diagnosis of COVID-19, admitted to a COVID-19 intermediate treatment centre in Sri Lanka between July and November 2021.

Interventions

All participants received inhaled beclomethasone 600 mcg or placebo two times per day, for 10 days from onset of symptoms/COVID-19 test becoming positive if asymptomatic or until reaching primary endpoint, whichever is earlier.

Primary outcome measure

Progression of asymptomatic, mild or moderate COVID-19 to severe COVID-19.

Secondary outcome measures

The number of days with a temperature of 38°C or more and the time to self-reported clinical recovery.

Results

A total of 385 participants were randomised to receive beclomethasone(n=193) or placebo(n=192) stratified by age (≤60 or >60 years) and sex. One participant from each arm withdrew from the study. All participants were included in final analysis. Primary outcome occurred in 24 participants in the beclomethasone group and 26 participants in the placebo group (RR 0.90 ; p=0.763). The median time for self-reported clinical recovery in all participants was 5 days (95% CI 3 to 7) in the beclomethasone group and 5 days (95% CI 3 to 8) in the placebo group (p=0.5). The median time for self-reported clinical recovery in patients with moderate COVID-19 was 5 days (95% CI 3 to 7) in the beclomethasone group and 6 days (95% CI 4 to 9) in the placebo group (p=0.05). There were no adverse events.

Conclusions

Early initiation of inhaled beclomethasone in patients with asymptomatic, mild or moderate COVID-19 did not reduce disease progression to severe COVID-19.

Trial registration number

Sri Lanka Clinical Trials Registry; SLCTR/2021/017.

Implementing a complex mental health intervention in occupational settings: process evaluation of the MENTUPP pilot study

Por: Tsantila · F. · Coppens · E. · De Witte · H. · Arensman · E. · Aust · B. · Pashoja · A. C. · Corcoran · P. · Cully · G. · De Winter · L. · Doukani · A. · Dushaj · A. · Fanaj · N. · Griffin · E. · Hogg · B. · Holland · C. · Leduc · C. · Leduc · M. · Mathieu · S. · Maxwell · M. · Ni Dhalaigh
Background

According to the Medical Research Council (MRC) framework, the theorisation of how multilevel, multicomponent interventions work and the understanding of their interaction with their implementation context are necessary to be able to evaluate them beyond their complexity. More research is needed to provide good examples following this approach in order to produce evidence-based information on implementation practices.

Objectives

This article reports on the results of the process evaluation of a complex mental health intervention in small and medium enterprises (SMEs) tested through a pilot study. The overarching aim is to contribute to the evidence base related to the recruitment, engagement and implementation strategies of applied mental health interventions in the workplace.

Method

The Mental Health Promotion and Intervention in Occupational Settings (MENTUPP) intervention was pilot tested in 25 SMEs in three work sectors and nine countries. The evaluation strategy of the pilot test relied on a mixed-methods approach combining qualitative and quantitative research methods. The process evaluation was inspired by the RE-AIM framework and the taxonomy of implementation outcomes suggested by Proctor and colleagues and focused on seven dimensions: reach, adoption, implementation, acceptability, appropriateness, feasibility and maintenance.

Results

Factors facilitating implementation included the variety of the provided materials, the support provided by the research officers (ROs) and the existence of a structured plan for implementation, among others. Main barriers to implementation were the difficulty of talking about mental health, familiarisation with technology, difficulty in fitting the intervention into the daily routine and restrictions caused by COVID-19.

Conclusions

The results will be used to optimise the MENTUPP intervention and the theoretical framework that we developed to evaluate the causal mechanisms underlying MENTUPP. Conducting this systematic and comprehensive process evaluation contributes to the enhancement of the evidence base related to mental health interventions in the workplace and it can be used as a guide to overcome their contextual complexity.

Trial registration number

ISRCTN14582090.

Haematological dynamics following treatment of visceral leishmaniasis: a protocol for systematic review and individual participant data (IPD) meta-analysis

Por: Munir · A. · Dahal · P. · Kumar · R. · Singh-Phulgenda · S. · Siddiqui · N. A. · Naylor · C. · Wilson · J. · Buck · G. · Rahi · M. · Alves · F. · Malaviya · P. · Sundar · S. · Ritmeijer · K. · Stepniewska · K. · Pandey · K. · Guerin · P. J. · Musa · A.
Introduction

Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An individual participant data meta-analysis (IPD-MA) is planned to characterise the haematological dynamics in patients with VL.

Methods and analysis

The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.

Ethics and dissemination

This IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (exempt granted on 29 March 2023, OxTREC REF: IDDO). Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (letter no.: RMRI/EC/30/2022) on 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.

PROSPERO registration number

CRD42021284622.

Health outcomes in those who have been victims of knife crime: a protocol for a systematic review and meta-analysis

Por: Gani · I. · Chandan · J. S. · Bandyopadhyay · S. · Pathmanathan · A. · Martin · J.
Introduction

Knife-enabled crime is a UK public health issue leading to substantial impacts on society, victims and their families, as well as additional strain on the healthcare system. Despite the increase in knife-enabled crime and the overwhelming consequences, there is a lack of comprehensive studies exploring the long-term health outcomes of knife crime victims in the UK. The research gap hinders the development of more targeted secondary preventative interventions, resource allocation and public awareness campaigns. This systematic review aims to identify the long-term health outcomes of knife crime victims, therefore providing valuable knowledge for stakeholders, health practitioners and policymakers for a more effective public health response.

Methods and analysis

A comprehensive search strategy was developed, focusing on four key concepts: study design, knife-related offences, outcomes and risk. Databases being searched include MEDLINE, EMBASE, PsycINFO, ProQuest Criminology Collection, Web of Science Core Collection, Google Scholar and OpenGrey. Reference lists and forward citations will be inspected for further suitable literature. The study selection will involve two independent reviewers screening the studies from the search, with disagreements resolved by a third reviewer. All UK quantitative research on long-term health outcomes of knife crime victims will be included in the review. Covidence will be used to efficiently manage data. A data extraction form has been developed which will summarise key aspects of each study that will be included in the review. Methodological Index for Non-Randomised Studies quality assessment checklist will be used to assess the studies and the Newcastle-Ottawa Scale will assess the risk of bias in each study. Findings will be narratively synthesised, and if heterogeneity is sufficient, a meta-analysis will be conducted.

Ethics and dissemination

Ethics approval is not required for this study as no original data will be collected. The results will be disseminated through a peer-reviewed publication and conference presentation.

Effects of socioeconomic status on patient-reported outcome after surgically treated trigger finger: a retrospective national registry-based study

Por: Lesand · L. · Dahlin · L. B. · Rydberg · M. · Zimmerman · M.
Objectives

To investigate if socioeconomic status impacts patient-reported outcomes after a surgically treated trigger finger (TF).

Design and setting

Data on patients with TF treated with surgery were collected from the Swedish National Quality Registry of Hand Surgery (HAKIR) 2010–2019 with an evaluation of symptoms and disability before surgery and at 3 and 12 months after surgery, using the short version of the Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire.

Data from HAKIR and the Swedish National Diabetes Registry (ndr.nu) were combined with socioeconomic data from Statistics Sweden (scb.sc), analysing the impact of marital status, education level, income, occupation, sickness benefits, days of unemployment, social assistance and migrant status on the outcome by a linear regression model.

Participants

In total, 5477 patients were operated on for primary TF during the study period, of whom 21% had diabetes, with a response rate of 35% preoperatively, 26% at 3 months and 25% at 12 months.

Results

At all time points, being born in Sweden (preoperatively B-coefficient: –9.74 (95% CI –13.38 to –6.11), 3 months postoperatively –9.80 (95% CI –13.82 to –5.78) and 12 months postoperatively –8.28 (95% CI –12.51 to –4.05); all p

Conclusion

Individuals with low earnings, high sick leave the same year as the surgery and those born outside of Sweden reported more symptoms both before and after surgery, but the relative improvement was not affected by socioeconomic factors.

Geospatial mapping of 2-hour access to timely essential surgery in the Philippines

Por: Lim · X. · Ayyappan · M. · Zaw · M. W. W. · Mandyam · N. K. · Chia · H. X. · Lucero-Prisno · D. E.
Objectives

Timely access to safe and affordable surgery is essential for universal health coverage. To date, there are no studies evaluating 2-hour access to Bellwether procedures (caesarean section, laparotomy, open fracture management) in the Philippines. The objectives of this study were to measure the proportion of the population able to reach a Bellwether hospital within 2 hours in the Philippines and to identify areas in the country with the most surgically underserved populations.

Methods

All public hospitals with Bellwether capacities were identified from the Philippines Ministry of Health website. The service area tool in ArcGIS Pro was used to determine the population within a 2-hour drive time of a Bellwether facility. Finally, suitability modelling was conducted to identify potential future sites for a surgical facility that targets the most underserved regions in the Philippines.

Results

428 Bellwether capable hospitals were identified. 85.1% of the population lived within 2 hours of one of these facilities. However, 6 regions had less than 80% of its population living within 2 hours of a Bellwether capable facility: Bicol, Eastern Visayas, Zamboanga, Autonomous region of Muslim Mindanao, Caraga and Mimaropa. Suitability analysis identified four regions—Caraga, Mimaropa, Calabarzon and Zamboanga—as ideal locations to build a new hospital with surgical capacity to improve access rates.

Conclusion

85.1% of the population of the Philippines are able to reach Bellwether capable hospitals within 2 hours, with regional disparities in terms of access rates. However, other factors such as weather, traffic conditions, financial access, availability of 24-hour surgical services and access to motorised vehicles should also be taken into consideration, as they also affect actual access rates.

Impact of an Acceptance and Commitment Therapy programme on HbA1c, self-management and psychosocial factors in adults with type 1 diabetes and elevated HbA1c levels: a randomised controlled trial

Por: Wijk · I. · Amsberg · S. · Johansson · U.-B. · Livheim · F. · Toft · E. · Anderbro · T.
Objective

To evaluate the impact of an Acceptance and Commitment Therapy (ACT) programme, tailored for people living with type 1 diabetes, on glycated haemoglobin (HbA1c), self-management and psychosocial factors among individuals with HbA1c>60 mmol/mol compared with treatment as usual (TAU).

Setting

An endocrinologic clinic in Sweden.

Participants

In this randomised controlled trial, 81 individuals with type 1 diabetes, aged 18–70 years with HbA1c>60 mmol/mol, were randomly assigned to either an ACT group intervention or TAU. Exclusion criteria were: unable to speak Swedish, untreated or severe psychiatric disease, cortisone treatment, untreated thyroid disease and newly started insulin pump therapy. At the 2-year follow-up, HbA1c was measured in 26 individuals.

Intervention

The ACT programme comprised seven 2-hour sessions held over 14 weeks and focused on acceptance of stressful thoughts and emotions, and to promote value-based committed action.

Outcomes

The primary outcome was HbA1c, and the secondary outcomes were measures of depression, anxiety, general stress, fear of hypoglycaemia, diabetes distress, self-care activities, psychological flexibility (general and related to diabetes) and quality of life. The primary endpoint was HbA1c 2 years after the intervention programme. Linear mixed models were used to test for an interaction effect between measurement time and group.

Results

Likelihood ratio test of nested models demonstrated no statistically significant interaction effect (2=0.49, p=0.485) between measurement time and group regarding HbA1c. However, a statistically significant interaction effect (likelihood ratio test 2=12.63, p

Conclusions

No statistically significant difference was found between the groups regarding the primary outcome measure, HbA1c. However, the ACT programme showed a persistent beneficial impact on psychological flexibility in the intervention group. The dropout rate was higher than expected, which may indicate a challenge in this type of study.

Trial registration number

NCT02914496.

Study protocol for a single-blind, parallel-group, randomised, controlled non-inferiority trial of 4-day intensive versus standard cognitive behavioural therapy for adults with obsessive-compulsive disorder

Por: Ivanova · E. · Fondberg · R. · Flygare · O. · Sannemalm · M. · Asplund · S. · Dahlen · S. · Sampaio · F. · Andersson · E. · Mataix-Cols · D. · Ivanov · V. Z. · Rück · C.
Introduction

Individual cognitive behavioural therapy (CBT) with exposure and response prevention is an effective treatment for obsessive–compulsive disorder (OCD). However, individual CBT is costly and time-consuming, requiring weekly therapy sessions for 3–4 months. A 4-day intensive version of CBT for OCD delivered in group format has been recently developed in Norway (Bergen 4-day treatment, B4DT). B4DT has shown promising results in several uncontrolled and one small, randomised trial, but its non-inferiority to the gold standard treatment has not been established.

Methods and analysis

This single-blind, randomised controlled trial including 120 patients (60 per arm) will compare B4DT to individual CBT. The primary outcome is the blind assessor-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS). We hypothesise that B4DT will be non-inferior to gold standard CBT 15 weeks after treatment start. The non-inferiority margin is set at four points on the Y-BOCS. Secondary outcomes include time to treatment response, cost-effectiveness, response and remission rates, drop-out rates and adverse events.

Ethics and dissemination

This study has been approved by the Swedish Ethical Review Authority. Hypotheses were specified and analysis code published before data collection started. Results from all analyses will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials and Consolidated Health Economic Evaluation Reporting Standards irrespective of outcome.

Trial registration number

NCT05608278.

Dynamic ambulance relocation: a scoping review

Por: Becker · J. · Kurland · L. · Höglund · E. · Hugelius · K.
Objectives

Dynamic ambulance relocation means that the operators at a dispatch centre place an ambulance in a temporary location, with the goal of optimising coverage and response times in future medical emergencies. This study aimed to scope the current research on dynamic ambulance relocation.

Design

A scoping review was conducted using a structured search in PubMed, Scopus and Web of Science. In total, 21 papers were included.

Results

Most papers described research with experimental designs involving the use of mathematical models to calculate the optimal use and temporary relocations of ambulances. The models relied on several variables, including distances, locations of hospitals, demographic-geological data, estimation of new emergencies, emergency medical services (EMSs) working hours and other data. Some studies used historic ambulance dispatching data to develop models. Only one study reported a prospective, real-time evaluation of the models and the development of technical systems. No study reported on either positive or negative patient outcomes or real-life chain effects from the dynamic relocation of ambulances.

Conclusions

Current knowledge on dynamic relocation of ambulances is dominated by mathematical and technical support data that have calculated optimal locations of ambulance services based on response times and not patient outcomes. Conversely, knowledge of how patient outcomes and the working environment are affected by dynamic ambulance dispatching is lacking. This review has highlighted several gaps in the scientific coverage of the topic. The primary concern is the lack of studies reporting on patient outcomes, and the limited knowledge regarding several key factors, including the optimal use of ambulances in rural areas, turnaround times, domino effects and aspects of working environment for EMS personnel. Therefore, addressing these knowledge gaps is important in future studies.

The Oxford Needle Experience (ONE) scale: a UK-based and US-based online mixed-methods psychometric development and validation study of an instrument to assess needle fear, attitudes and expectations in the general public

Por: Kantor · J. · Vanderslott · S. · Morrison · M. · Pollard · A. J. · Carlisle · R. C.
Objectives

To develop and validate the Oxford Needle Experience (ONE) scale, an instrument to assess needle fear, attitudes and expectations in the general population.

Design

Cross-sectional validation study.

Setting

Internet-based with participants in the UK and USA.

Participants

UK and US representative samples stratified by age, sex, and ethnicity using the Prolific Academic platform.

Main outcome measures

Exploratory factor analysis with categorical variables and a polychoric correlation matrix followed by promax oblique rotation on the UK sample for the ONE scale. Confirmatory factor analysis (CFA) with a Satorra-Bentler scaled test statistic evaluating the root mean squared error of approximation (RMSEA), standardised root mean squared residual (SRMR) and comparative fit index (CFI) on the US sample. Reliability as internal consistency using McDonald’s omega. Convergent validity using the Pearson correlation coefficient. Predictive and discriminant validity using logistic regression ORs of association (OR).

Results

The population included 1000 respondents, 500 in the UK and 500 in the USA. Minimum average partial correlation and a scree plot suggested four factors should be retained: injection hesitancy, blood-related hesitancy, recalled negative experiences and perceived benefits, yielding a 19-question scale. On CFA, the RMSEA was 0.070 (90% CI, 0.064 to 0.077), SRMR 0.053 and CFI 0.925. McDonald’s omega was 0.92 and 0.93 in the UK and US samples, respectively. Convergent validity with the four-item Oxford Coronavirus Explanations, Attitudes and Narratives Survey (OCEANS) needle fear scale demonstrated a strong correlation (r=0.83). Predictive validity with a single-question COVID-19 vaccination status question demonstrated a strong association, OR (95% CI) 0.97 (0.96 to 0.98), p

Conclusions

The ONE scale is a reliable and valid multidimensional scale that may be useful in predicting vaccine hesitancy, designing public health interventions to improve vaccine uptake and exploring alternatives to needles for medical procedures.

Sequence analysis of sickness absence and disability pension days in 2012-2018 among privately employed white-collar workers in Sweden: a prospective cohort study

Por: Salonen · L. · Alexanderson · K. · Farrants · K.
Objective

The aim of the study is to explore sequences of sickness absence (SA) and disability pension (DP) days from 2012 to 2018 among privately employed white-collar workers.

Design

A 7-year prospective cohort study using microdata from nationwide registers.

Setting

Sweden.

Participants

All 1 283 516 privately employed white-collar workers in Sweden in 2012 aged 18–67.

Methods

Sequence analysis was used to describe clusters of individuals who followed similar development of SA and DP net days/year, and multinomial logistic regression to analyse associations between sociodemographic variables and belonging to each observed cluster of sequences. Odds ratios (ORs) and 95% confidence intervals (CIs) were adjusted for baseline sociodemographics.

Results

We identified five clusters of SA and DP sequences: (1) ‘low or no SA or DP’ (88.7% of the population), (2) ‘SA due to other than mental diagnosis’ (5.2%), (3) ‘SA due to mental diagnosis’ (3.4%), (4) ‘not eligible for SA or DP’ (1.4%) and (5) ‘DP’ (1.2%). Men, highly educated, born outside Sweden and high-income earners were more likely to belong to the first and the fourth cluster (ORs 1.13–4.49). The second, third and fifth clusters consisted mainly of women, low educated and low-income (ORs 1.22–8.90). There were only small differences between branches of industry in adjusted analyses, and many were not significant.

Conclusion

In general, only a few privately employed white-collar workers had SA and even fewer had DP during the 7-year follow-up. The risk of belonging to a cluster characterised by SA or DP varied by sex, levels of education and income, and other sociodemographic factors.

Consensus building on definitions and types of child maltreatment to improve recording and surveillance in Europe: protocol for a multi-sectoral, European, electronic Delphi study

Por: Nurmatov · U. · Cowley · L. E. · Rodrigues · L. B. · Naughton · A. · Debelle · G. · Alfandari · R. · Lamela · D. · Otterman · G. · Jud · A. · Ntinapogias · A. · Laajasalo · T. · Soldino · V. · Stancheva · V. · Caenazzo · L. · Vaughan · R. · Christian · C. W. · Drabarek · K. · Kemp · A. M.
Introduction

Child maltreatment (CM) is a complex global public health issue with potentially devastating effects on individuals’ physical and mental health and well-being throughout the life course. A lack of uniform definitions hinders attempts to identify, measure, respond to, and prevent CM. The aim of this electronic Delphi (e-Delphi) study is to build consensus on definitions and types of CM for use in surveillance and multi-sectoral research in the 34 countries in the Euro-CAN (Multi-Sectoral Responses to Child Abuse and Neglect in Europe) project (COST Action CA19106).

Methods and analysis

The e-Delphi study will consist of a maximum of three rounds conducted using an online data collection platform. A multi-disciplinary expert panel consisting of researchers, child protection professionals (health and social care), police, legal professionals and adult survivors of CM will be purposefully recruited. We will approach approximately 100 experts, with between 50 and 60 of these anticipated to take part. Participants will rate their agreement with a range of statements relating to operational definitions and types of CM, and free-text comments on each of the statements to give further detail about their responses and areas of uncertainty. Consensus has been defined a priori as ≥70% of the panel agreeing or disagreeing with the statement after the final round. The responses to the open-ended questions will be analysed using a ‘codebook’ approach to thematic analysis, and used to refine the statements between rounds where no consensus is reached.

Ethics and dissemination

Ethical approval has been granted from the Cardiff University School of Medicine ethics committee (reference number SMREC22/96). Results will be submitted for publication in a peer-reviewed journal and presented at workshops (including for the participants) and international academic conferences. The Euro-CAN network will also be used to disseminate the results, with results briefings and presentations to key public health and other relevant organisations in the field.

'Super Rehab: can we achieve coronary artery disease regression? A feasibility study protocol

Por: Graby · J. · Khavandi · A. · Gillison · F. · Smith · T. · Murphy · D. · Peacock · O. · McLeod · H. · Dastidar · A. · Antoniades · C. · Thompson · D. · Rodrigues · J. C. L.
Introduction

Patients diagnosed with coronary artery disease (CAD) are currently treated with medications and lifestyle advice to reduce the likelihood of disease progression and risk of future major adverse cardiovascular events (MACE). Where obstructive disease is diagnosed, revascularisation may be considered to treat refractory symptoms. However, many patients with coexistent cardiovascular risk factors, particularly those with metabolic syndrome (MetS), remain at heightened risk of future MACE despite current management.

Cardiac rehabilitation is offered to patients post-revascularisation, however, there is no definitive evidence demonstrating its benefit in a primary prevention setting. We propose that an intensive lifestyle intervention (Super Rehab, SR) incorporating high-intensity exercise, diet and behavioural change techniques may improve symptoms, outcomes, and enable CAD regression.

This study aims to examine the feasibility of delivering a multicentre randomised controlled trial (RCT) testing SR for patients with CAD, in a primary prevention setting.

Methods and analysis

This is a multicentre randomised controlled feasibility study of SR versus usual care in patients with CAD. The study aims to recruit 50 participants aged 18–75 across two centres. Feasibility will be assessed against rates of recruitment, retention and, in the intervention arm, attendance and adherence to SR. Qualitative interviews will explore trial experiences of study participants and practitioners. Variance of change in CAD across both arms of the study (assessed with serial CT coronary angiography) will inform the design and power of a future, multi-centre RCT.

Ethics and dissemination

Ethics approval was granted by South West—Frenchay Research Ethics Committee (reference: 21/SW/0153, 18 January 2022). Study findings will be disseminated via presentations to relevant stakeholders, national and international conferences and open-access peer-reviewed research publications.

Trial registration number

ISRCTN14603929.

Qualitative exploration of the perceptions of exercise in patients with cancer initiated during chemotherapy: a meta-synthesis

Por: Andersen · C. · Adamsen · L. · Damhus · C. S. · Piil · K. · Missel · M. · Jarden · M. · Larsen · A. · Larsen · H. B. · Moller · T.
Objective

To synthesise qualitative literature on (1) the perceptions of patients with cancer of participating in an exercise intervention while undergoing chemotherapy and (2) to inform and guide professionals in oncology and haematology practice.

Design

A qualitative meta-synthesis based on Noblit and Hare’s seven-step meta-ethnography.

Data sources

Six electronic databases: Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, EMBASE, PubMed, SCI-Expanded—SSCI and Scopus (final search June 2022) were used to identify qualitative literature containing individual or focus group interviews. The transparency of reporting for each study was assessed using the Consolidated criteria for Reporting Qualitative research checklist.

Results

The search identified 5002 articles, 107 of which were selected for full-text review. Seventeen articles from five countries with patients undergoing chemotherapy during exercise interventions were included. Eleven articles were included in the meta-synthesis, which comprised 193 patients with various cancer diagnoses, disease stages, sexes and ages. Four main themes were identified: chemotherapy overpowers the body; exercise in battle with side effects; a break from gloomy thoughts; and a question of survivorship.

Conclusions and implications

The meta-synthesis emphasised that patients with cancer undergoing chemotherapy and simultaneously participating in exercise interventions may experience momentary relief from overwhelming side effects, even though full bodily recovery may be perceived as a distant prospect. The synthesis offers a sparse empirical basis for gaining insight into what patients experience existentially following exercise interventions. It is up to patients to independently apply the transfer value of exercise to their own existential circumstances.

Effectiveness, acceptability, and completeness and quality of intervention reporting of psychological interventions for people with dementia or mild cognitive impairment: protocol for a mixed-methods systematic review

Por: Svedin · F. · Blomberg · O. · Farrand · P. · Brantnell · A. · von Essen · L. · Aberg · A. C. · Woodford · J.
Introduction

Mental health difficulties such as anxiety and depression have negative impacts on psychological well-being and are common in people with dementia and mild cognitive impairment. However, access to psychological treatments is limited. This mixed-method systematic review will: (1) examine the effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment; (2) examine the effectiveness of these psychological interventions to improve mental health and psychological well-being in informal caregivers; (3) examine potential clinical and methodological moderators associated with effectiveness; (4) explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders; and (5) examine the completeness and quality of intervention reporting.

Methods and analysis

Electronic databases (ASSIA, CENTRAL, CINAHL, EMBASE, PsycINFO and MEDLINE) will be systematically searched and supplemented with expert contact, reference and citation checking, and grey literature searches. If possible, we will conduct a meta-analysis to examine the overall effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment and their informal caregivers; and examine potential clinical and methodological moderators associated with effectiveness. We will conduct a deductive framework synthesis, informed by the theoretical framework of acceptability, to explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders. In accordance with Joanna Briggs Institute guidance, we will adopt a convergent segregated approach to data synthesis and integration of quantitative and qualitative findings. We will examine the completeness and quality of intervention reporting according to the Template for Intervention Description and Replication checklist and guide.

Ethics and dissemination

No primary data will be collected, and therefore, ethical approval is not required. Results will be disseminated through a peer-reviewed publication, academic conferences, and plain language summaries.

PROSPERO registration number

CRD42023400514.

Family-focused intervention to promote adolescent mental health and well-being in Moldova and North Macedonia (FLOURISH): feasibility study protocol

Por: Shenderovich · Y. · Piolanti · A. · Babii · V. · Calovska-Hertzog · N. · Evans · R. E. · Heinrichs · N. · Burgund Isakov · A. · Lesco · G. · Moore · G. · Mueller · J. · Raleva · M. · Shimbov · B. · Simon · J. · Waller · F. · Wienand · D. · Foran · H. M.
Introduction

Family-Focused Adolescent & Lifelong Health Promotion (FLOURISH) project will adapt, implement and evaluate a programme to support adolescent mental health and well-being through strategies, such as strengthening parenting practices, adolescent-caregiver relationships, adolescent and parent socioemotional skills, and social support.

Methods and analysis

The project will focus on adolescents aged 10–14 years and their caregivers in North Macedonia and Moldova. The countries were selected based on implementation readiness of two organisations and a need for accessible evidence-informed services to help mitigate health risks due to economic, social and political challenges. Parenting for Lifelong Health (PLH) for Parents and Teens is a family-based programme developed for low-resource settings. PLH has been adapted with input from advisory groups. The programme includes additional components to strengthen impacts on adolescents: adolescent mental health tools, based on UNICEF’s Helping Adolescents Thrive, adolescent peer support and participation booster. This pilot is first of three study phases. The pilot will be a feasibility testing of the adapted intervention and the assessment and implementation procedures to determine further refinements. The pilot will examine if the adapted programme is acceptable for adolescents, their families and providers, explore contextual factors relevant to embedding this programme into longer-term scale-up and investigate whether the programme can be delivered with fidelity and participation; whether the participants report changes in adolescent emotional and behavioural problems, well-being and other outcomes; and whether the study tools are feasible and appropriate. Pre-post adolescent and caregiver questionnaires will provide outcome data. Process evaluation will include attendance and fidelity data, and focus groups. We will examine delivery cost and resource requirements.

Ethics and dissemination

The study was approved at the University of Klagenfurt (Austria), Medical Faculty at St. Cyril and Methodius University (North Macedonia) and National Committee of Ethical Expertise for Clinical Trials (Moldova). Through stakeholder engagement and dissemination, FLOURISH will advance scale-up of open-source family interventions.

Trial registration number

Trial registration: ID101095528; project page: https://www.flourish-study.org/about.html; https://www.linkedin.com/company/flourish-study/

Influence of physical fitness components on personality factors and risk perception of children and adolescents: a cross-sectional study

Objectives

To examine the associations of cardiorespiratory fitness (VO2 max) and muscular strength with indicators related to the risk scale, such as perceived competence, sensation seeking, competitiveness, risk taking and risk perception in sports.

Design

Cross-sectional study.

Setting

High schools from the Region of Murcia (Spain).

Participants

Three-hundred-and-seventeen adolescents participated (mean age: 13.69±1.2 years old).

Primary and secondary outcome measures

Body mass, body height, Course-Navette test, upper limb strength and psychoeducational factors that determine the propensity towards sports accidents in school children, the Sports Accident Propensity Scale were evaluated. It was performance t-test for independent samples, stepwise multiple linear regression models and a multiple mediation analysis.

Results

The analysis showed significant differences with respect to sex in height, VO2 max, handgrip strength and in all factors of the questionnaire (p=0.02-2 max, strength in the handgrip test and age showed a higher score in factors 1 and 3. Higher scores in factor 2 were associated with better VO2 max and strength in handgrip test. Youngers and better values of strength in the handgrip showed higher score in factors 4 and 5. The mediation analysis with two mediating variables (handgrip strength and VO2 max) showed a significant indirect effect. When handgrip strength and VO2 max were included in the equations, the association between sex and each factor ceased to be significant.

Conclusion

This study highlights the potential benefits of muscular strength (handgrip) and VO2 max in the perceived risk scale, and the variable of age on this.

Trial registration number

Clinical trial: NCT05544370 (pre-results).

Test negative case-control study of COVID-19 vaccine effectiveness for symptomatic SARS-CoV-2 infection among healthcare workers: Zambia, 2021-2022

Por: Mweso · O. · Simwanza · J. · Malambo · W. · Banda · D. · Fwoloshi · S. · Sinyange · N. · Yoo · Y. M. · Feldstein · L. R. · Kapina · M. · Mulenga · L. B. · Liwewe · M. M. · Musonda · K. · Kapata · N. · Mwansa · F. D. · Agolory · S. · Bobo · P. · Hines · J. · Chilengi · R.
Objectives

The study aim was to evaluate vaccine effectiveness (VE) of COVID-19 vaccines in preventing symptomatic COVID-19 among healthcare workers (HCWs) in Zambia. We sought to answer the question, ‘What is the vaccine effectiveness of a complete schedule of the SARS-CoV-2 vaccine in preventing symptomatic COVID-19 among HCWs in Zambia?’

Design/setting

We conducted a test-negative case–control study among HCWs across different levels of health facilities in Zambia offering point of care testing for COVID-19 from May 2021 to March 2022.

Participants

1767 participants entered the study and completed it. Cases were HCWs with laboratory-confirmed SARS-CoV-2 and controls were HCWs who tested SARS-CoV-2 negative. Consented HCWs with documented history of vaccination for COVID-19 (vaccinated HCWs only) were included in the study. HCWs with unknown test results and unknown vaccination status, were excluded.

Primary and secondary outcome measures

The primary outcome was VE among symptomatic HCWs. Secondary outcomes were VE by: SARS-CoV-2 variant strains based on the predominant variant circulating in Zambia (Delta during May 2021 to November 2021 and Omicron during December 2021 to March 2022), duration since vaccination and vaccine product.

Results

We recruited 1145 symptomatic HCWs. The median age was 30 years (IQR: 26–38) and 789 (68.9%) were women. Two hundred and eighty-two (24.6%) were fully vaccinated. The median time to full vaccination was 102 days (IQR: 56–144). VE against symptomatic SARS-CoV-2 infection was 72.7% (95% CI: 61.9% to 80.7%) for fully vaccinated participants. VE was 79.4% (95% CI: 58.2% to 90.7%) during the Delta period and 37.5% (95% CI: –7.0% to 63.3%) during the Omicron period.

Conclusions

COVID-19 vaccines were effective in reducing symptomatic SARS-CoV-2 among Zambian HCWs when the Delta variant was circulating but not when Omicron was circulating. This could be related to immune evasive characteristics and/or waning immunity. These findings support accelerating COVID-19 booster dosing with bivalent vaccines as part of the vaccination programme to reduce COVID-19 in Zambia.

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