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Protocol of a scoping review of outcome domains in dermatology

Por: Nadir · U. · Ahmed · A. · Yi · M. D. · Hisham · F. I. · Dave · L. · Kottner · J. · Ezzedine · K. · Garg · A. · Ingram · J. R. · Jemec · G. B. E. · Spuls · P. I. · Kirkham · J. J. · Cahn · B. · Alam · M.
Introduction

Core outcome sets (COSs) are agreed outcomes (domains (subdomains) and instruments) that should be measured as a minimum in clinical trials or practice in certain diseases or clinical fields. Worldwide, the number of COSs is increasing and there might be conceptual overlaps of domains (subdomains) and instruments within disciplines. The aim of this scoping review is to map and to classify all outcomes identified with COS projects relating to skin diseases.

Methods and analysis

We will conduct a scoping review of outcomes of skin disease-related COS initiatives to identify all concepts and their definitions. We will search PubMed, Embase and Cochrane library. The search dates will be 1 January 2010 (the point at which Core Outcome Measures in Effectiveness Trials (COMET) was established) to 1 January 2024. We will also review the COMET database and C3 website to identify parts of COSs (domains and/or instruments) that are being developed and published. This review will be supplemented by querying relevant stakeholders from COS organisations, dermatology organisations and patient organisations for additional COSs that were developed. The resulting long lists of outcomes will then be mapped into conceptually similar concepts.

Ethics and dissemination

This study was supported by departmental research funds from the Department of Dermatology at Northwestern University. An ethics committee review was waived since this protocol was done by staff researchers with no involvement of patient care. Conflicts of interests, if any, will be addressed by replacing participants with relevant conflicts or reassigning them. The results will be disseminated through publication in peer-reviewed journals, social media posts and promotion by COS organisations.

Excess winter mortality in Finland, 1971-2019: a register-based study on long-term trends and effect modification by sociodemographic characteristics and pre-existing health conditions

Por: Suulamo · U. · Remes · H. · Tarkiainen · L. · Murphy · M. · Martikainen · P.
Objectives

Excess winter mortality is a well-established phenomenon across the developed world. However, whether individual-level factors increase vulnerability to the effects of winter remains inadequately examined. Our aim was to assess long-term trends in excess winter mortality in Finland and estimate the modifying effect of sociodemographic and health characteristics on the risk of winter death.

Design

Nationwide register study.

Setting

Finland.

Participants

Population aged 60 years and over, resident in Finland, 1971–2019.

Outcome measures

Age-adjusted winter and non-winter death rates, and winter-to-non-winter rate ratios and relative risks (multiplicative interaction effects between winter and modifying characteristics).

Results

We found a decreasing trend in the relative winter excess mortality over five decades and a drop in the series around 2000. During 2000–2019, winter mortality rates for men and women were 11% and 14% higher than expected based on non-winter rates. The relative risk of winter death increased with age but did not vary by income. Compared with those living with at least one other person, individuals in institutions had a higher relative risk (1.07, 95% CI 1.05 to 1.08). Most pre-existing health conditions did not predict winter death, but persons with dementia emerged at greater relative risk (1.06, 95% CI 1.04 to 1.07).

Conclusions

Although winter mortality seems to affect frail people more strongly—those of advanced age, living in institutions and with dementia—there is an increased risk even beyond the more vulnerable groups. Protection of high-risk groups should be complemented with population-level preventive measures.

Measuring patients experience of nursing quality in acute hospitals: review of existing scales and development and psychometric validation of a new scale

Por: Blume · K. S. · Kirchner-Heklau · U. · Winter · V. · Meyer · G. · Fleischer · S.
Objective

To provide an overview of existing instruments measuring patient-perceived quality of nursing care and to develop and psychometrically evaluate a new multidimensional scale applicable to the German acute care sector.

Design

We conducted a scale development and validation study involving the following phases: (1) performing a structured literature search to identify existing scales, (2) generating an initial pool of items using the results of the literature search and expert interviews, (3) coding/categorising the item pool, (4) organising a peer researcher workshop to select relevant items, (5) drafting the survey questionnaire and conducting cognitive pretesting, (6) pilot testing the survey questionnaire, (7) administering the survey to a large sample of hospital patients and (8) conducting a psychometric evaluation comprising exploratory factor analysis using the survey results, followed by confirmatory factor analysis and reliability and validity assessment of the resulting draft scale.

Survey participants

17 859 recently hospitalised patients discharged from non-intensive care in non-paediatric and non-psychiatric hospital units in Germany between May and October 2019.

Results

We identified 32 instruments comprising 635 items on nursing care quality. Alongside 135 indicators derived from expert interviews, these formed our initial item pool, which we coded into 15 categories. From this pool, 36 items were selected in the peer researcher workshop for pretesting and psychometric evaluation. Based on the results of our exploratory and confirmatory factor analyses, we propose a second-order scale to measure Patients’ Experience of Nursing Quality in Acute Hospitals (PENQuAH), including the two higher-order dimensions ‘patients’ perception of direct nursing care activities’ and ‘patients’ perception of guidance provided by nurses’. The results of various tests suggest the scale has sufficient goodness of fit, reliability and validity.

Conclusions

The PENQuAH scale is promising in terms of its psychometric properties, the plausibility and meaningfulness of its dimensions, and its ease of use.

Caregivers with limited language proficiency and their satisfaction with paediatric emergency care related to the use of professional interpreters: a mixed methods study

Por: Gmünder · M. · Gessler · N. · Buser · S. · Feuz · U. · Fayyaz · J. · Jachmann · A. · Keitel · K. · Brandenberger · J.
Objectives

Communication is a main challenge in migrant health and essential for patient safety. The aim of this study was to describe the satisfaction of caregivers with limited language proficiency (LLP) with care related to the use of interpreters and to explore underlying and interacting factors influencing satisfaction and self-advocacy.

Design

A mixed-methods study.

Setting

Paediatric emergency department (PED) at a tertiary care hospital in Bern, Switzerland.

Participants and methods

Caregivers visiting the PED were systematically screened for their language proficiency. Semistructured interviews were conducted with all LLP-caregivers agreeing to participate and their administrative data were extracted.

Results

The study included 181 caregivers, 14 of whom received professional language interpretation. Caregivers who were assisted by professional interpretation services were more satisfied than those without (5.5 (SD)±1.4 vs 4.8 (SD)±1.6). Satisfaction was influenced by five main factors (relationship with health workers, patient management, alignment of health concepts, personal expectations, health outcome of the patient) which were modulated by communication. Of all LLP-caregivers without professional interpretation, 44.9% were satisfied with communication due to low expectations regarding the quality of communication, unawareness of the availability of professional interpretation and overestimation of own language skills, resulting in low self-advocacy.

Conclusion

The use of professional interpreters had a positive impact on the overall satisfaction of LLP-caregivers with emergency care. LLP-caregivers were not well—positioned to advocate for language interpretation. Healthcare providers must be aware of their responsibility to guarantee good-quality communication to ensure equitable quality of care and patient safety.

Caregiving in the COVID‐19 pandemic: Family adaptations following an intensive care unit hospitalisation

Abstract

Aim and Objective

To identify how family caregivers adapt to the caregiving role following a relative's COVID-19-related intensive care unit (ICU) hospitalisation.

Background

Family caregiving is often associated with poor health amongst caregivers which may limit their capacity to effectively support patients. Though severe COVID-19 infection has necessitated increasing numbers of persons who require caregiver support, little is known about these caregivers, the persons they are caring for, or the strategies used to effectively adjust to the caregiving role.

Design

A qualitative descriptive study design was adopted, and findings are reported using COREQ.

Methods

A secondary analysis of transcripts from semi-structured interviews conducted with recently discharged ICU patients who had COVID-19 (n = 16) and their family caregivers (n = 16) was completed using thematic analysis. MAXQDA 2020 and Miro were used to organise data and complete coding. Analysis involved a structured process of open and closed coding to identify and confirm themes that elucidated adaptation to family caregiving.

Results

Six themes highlight how family caregivers adapt to the caregiving role following an ICU COVID-19-related hospitalisation including (1) engaging the support of family and friends, (2) increased responsibilities to accommodate caregiving, (3) managing emotions, (4) managing infection control, (5) addressing patient independence and (6) engaging support services. These themes were found to be congruent with the Roy adaptation model.

Conclusions

Family caregiving is a stressful transition following a patient's acute hospitalisation. Effective adaptation requires flexibility and sufficient support, beginning with the care team who can adequately prepare the family for the anticipated challenges of recovery.

Relevance to Clinical Practice

Clinical teams may improve post-hospitalisation care outcomes of patients by preparing families to effectively adjust to the caregiver role—particularly in identifying sufficient support resources.

Patient or Public Contribution

Participation of patients/caregivers in this study was limited to the data provided through participant interviews.

Where are the inequalities in colorectal cancer care in a country with universal healthcare? A systematic review and narrative synthesis

Por: Pickwell-Smith · B. A. · Spencer · K. · Sadeghi · M. H. · Greenley · S. · Lind · M. · Macleod · U.
Objective

Patients diagnosed with colorectal cancer living in more deprived areas experience worse survival than those in more affluent areas. Those living in more deprived areas face barriers to accessing timely, quality healthcare. These barriers may contribute to socioeconomic inequalities in survival. We evaluated the literature for any association between socioeconomic group, hospital delay and treatments received among patients with colorectal cancer in the UK, a country with universal healthcare.

Design

MEDLINE, EMBASE, CINAHL, CENTRAL, SCIE, AMED and PsycINFO were searched from inception to January 2023. Grey literature, including HMIC, BASE and Google Advanced Search, and forward and backward citation searches were conducted. Two reviewers independently reviewed titles, abstracts and full-text articles. Observational UK-based studies were included if they reported socioeconomic measures and an association with either hospital delay or treatments received. The QUIPS tool assessed bias risk, and a narrative synthesis was conducted. The review is reported to Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020.

Results

41 of the 7209 identified references were included. 12 studies evaluated 7 different hospital intervals. There was a significant association between area-level deprivation and a longer time from first presentation in primary care to diagnosis. 32 studies evaluated treatments received. There were socioeconomic inequalities in surgery and chemotherapy but not radiotherapy.

Conclusion

Patients with colorectal cancer face inequalities across the cancer care continuum. Further research is needed to understand why and what evidence-based actions can reduce these inequalities in treatment. Qualitative research of patients and clinicians conducted across various settings would provide a rich understanding of the complex factors that drive these inequalities. Further research should also consider using a causal approach to future studies to considerably strengthen the interpretation. Clinicians can try and mitigate some potential causes of colorectal cancer inequalities, including signposting to financial advice and patient transport schemes.

PROSPERO registration number

CRD42022347652.

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.

Five-year cross-sectional study to determine the burden of Candida spp. infections of the urinary tract system among patients attending tertiary hospital in Northwestern Tanzania

Por: Konje · E. T. · Kizenga · O. · Charco · N. J. · Kibwana · U. O. · Shango · N. · Tarimo · F. · Mushi · M. F.
Objective

Urinary tract infections (UTIs) stand as a prominent global health concern. This study entails a 5-year retrospective analysis, using a cross-sectional study design to examine microbiology laboratory data of individuals clinically diagnosed with UTIs at Bugando Medical Centre to gain insights into the prevalence and factors linked to candiduria.

Methodology

Data extracted were meticulously cleaned and coded in an MS Excel sheet, subsequently transferred to STATA V.15 for analysis. Binary logistic regression analysis was used to identify factors associated with candiduria. A probability value below 0.05 at a 95% CI was considered statistically significant.

Results

Urine samples for culture and sensitivity comprised 33.4% (20755) of the total biological samples (62335). The median age of the patients stood at 19 years. A slight majority were female, accounting for 52.8% (10051), and two-thirds sought treatment at outpatient departments (67.5%, 12843). Among patients with significant pathogenic growth, the prevalence of candiduria was 4.6% (221 out of 4772). Notably, inpatients exhibited a higher incidence of candiduria compared with outpatients, with rates of 9.4% (1882) versus 1.6% (2890), p value of 0.000. Non-albicans Candida spp. (NAC) remained the most prevalent pathogen. Factors significantly associated with candiduria included being female (OR=1.7, 95% CI 1.3 to 2.3) and hospital admission (OR=6.6, 95% CI 4.7 to 9.2). In conclusion, candiduria affect 5 out of every 100 UTI-diagnosed patients, predominantly among females and those admitted to the hospital. Clinicians at tertiary hospitals should consider urinary candidiasis as a potential diagnosis for patients at risk who present with UTI-like symptoms.

Acceptance of COVID-19 vaccine and associated factors among healthcare workers in Katsina state: a cross-sectional study in Northwest Nigeria

Por: Abubakar · A. T. · Suleiman · K. · Ahmad · S. I. · Yahaya · S. S. · Bello · U. I. · Suleiman · B. A. · Haladu · S. A. · Al-Mustapha · A. I. · Abubakar · M. I.
Objectives

Healthcare workers were prioritised to receive the COVID-19 vaccine in Nigeria. Administration of COVID-19 vaccination in Nigeria was challenging because of a lack of trust in vaccine safety and vaccine effectiveness among healthcare workers, who are expected to provide reliable information about vaccines and vaccine-preventable diseases in the communities. Hence, their acceptance and attitudes towards COVID-19 preventive practices could influence the acceptance of the vaccine by the local population. This cross-sectional study assessed the acceptance of the COVID-19 vaccine among healthcare workers in Katsina State. We predicted the variables that increased the vaccine acceptance using logistic regression analysis.

Setting

This hospital-based study was conducted at primary, secondary and tertiary healthcare facilities in Nigeria.

Participants

A total of 793 healthcare workers were included in this study. Of these, 65.4% (n=519) were male.

Outcome measures

To assess acceptance of COVID-19 vaccine measures, and factors increasing acceptance among healthcare workers.

Results

Of the healthcare workers, 80% (638) were tested for the SARS-CoV-2, of whom 10.8% (n=65) tested positive. Approximately 97% (n=765) of them believed that the COVID-19 vaccine was safe, and 90% (n=714) received the first dose of the vaccine. Healthcare workers between 30 and 39 years were more likely to accept the vaccine (aOR: 7.06; 95% CI 2.36 to 21.07; p

Conclusions

Our findings showed that the age and prior COVID-19 testing were the main factors influencing the acceptance of the COVID-19 vaccine. There was high acceptance of the COVID-19 vaccine among healthcare workers in Katsina State, Nigeria. Future studies should focus on the completion of doses and serological testing for immunity.

Self-Management Analysis in Chronic Conditions (SMACC) checklist: an international consensus-based tool to develop, compare and evaluate self-management support programmes

Por: Moreels · T. · Cruyt · E. · De Baets · S. · Andries · L. · Arts-Tielemans · M. · Rodriguez-Bailon · M. · Bergström · A. · Boete · K. · Bormans · I. · Costa · U. · Declercq · H. · Dekelver · S. · Dekyvere · V. · Delooz · E. · Engels · C. · Helderweirt · S. · Jarrey · M. · Lenaerts · A.
Objectives

The Self-Management Analysis in Chronic Conditions (SMACC) checklist was developed as a guidance tool to support the development, comparison and evaluation of self-management support programmes for persons with a chronic condition. The checklist was based on a previously performed concept analysis of self-management. The aim of this study was to validate its content using an international Delphi study and to deliver a final version.

Design

A two-round Delphi study was conducted between October 2022 and January 2023. Using the researchers’ networks, professionals with research or clinical expertise in self-management support and chronic conditions were recruited via online purposive snowball sampling. Participants were asked to score each item of the checklist (16 items total) on 3 content validity indicators: (1) clarity and comprehensibility, (2) relevance and importance and (3) degree of alignment with the overall goal of the checklist to promote adequate and comprehensive self-management support programmes. A consensus threshold of 75% agreement was used. The participants were also asked general questions about the checklist as a whole and were asked to provide feedback considering its refinement.

Results

Fifty-four professionals with an average 14.5 years of experience participated in round 1, 48 with an average 12.5 years of experience participated in round 2. The majority of professionals were from Western Europe. For the majority of items consensus was reached after round 1. In round 2, 3 of the 4 remaining items reached consensus, 1 last item was retained based on highly recurring feedback.

Conclusions

The SMACC checklist was considered a valid and comprehensive tool to aid the development, evaluation and comparison of self-management support programmes. It was acknowledged as a useful instrument to supplement existing frameworks and was seen as feasible to implement in both research and clinical settings. Further validation in the field, with input from patients and peer experts, will be valuable.

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.

Perceptions of academic staff and students of senior high school in implementing game-based exercises in physical education classes--a research protocol for a qualitative descriptive study

Por: Manlapaz · D. · Vergara · J. A. · Alpuerto · K. M. B. · De Los Santos · I. K. S. · Enriquez · M. U. · Manicio · Z. Z. · Mendres · J. E. F. · Tolosa · C. G. S. · Vilela · Z. G. D. · Zabat · Z. E. G. A.
Background

The COVID-19 pandemic has taken a toll on both physical activity and fitness as several pursuits and activities have been restricted. Coupled with this, increased food intake and sedentary lifestyles have produced poor physical health outcomes. Online physical education classes have been more difficult to conduct given the limitations of the setup. As such, exergaming has been identified as a possible educational tool that could improve students’ motivation, participation and fitness levels and reduce negative behaviours in class while contributing to the current curriculum.

Objectives

The study explores the perspectives of both the physical education academic staff and senior high school students from the University of Santo Tomas on the implementation of exergaming to determine the feasibility of exergaming as an educational tool in the Philippines’ physical education curriculum.

Methodology

A descriptive qualitative design will be used and participants will be selected through criterion sampling. The authors will conduct a process of question development and pilot FGDs beforehand to ensure smooth proceedings. Once done, they will undergo FGDs conducted through Google Meet. Data will be coded and analysed via thematic analysis using manual coding and NVivo V.12 software to summarise central themes and perceptions.

Ethics and dissemination

This study will abide by the Nuremberg Code, Declaration of Helsinki, Belmont Report, Data Privacy Act of 2012 and National Ethical Guidelines (for health-related research) of 2017. The study has received approval from the University of Santo Tomas (UST)-College of Rehabilitation Sciences (CRS) Ethics Review Committee. All participant data will be labelled according to random two-digit computer generated codes to preserve anonymity and stored in password-protected laptops and Google Drive folders to preserve confidentiality. Results will be made available to individual UST physical education academic staff and senior high school students prior to publication in peer-reviewed journal.

Suicidality Treatment Occurring in Paediatrics (STOP) Medication Suicidality Side Effects Scale in young people in two cohorts across Europe

Por: Santosh · P. · Sala · R. · Lievesley · K. · Singh · J. · Arango · C. · Buitelaar · J. K. · Castro-Fornieles · J. · Coghill · D. · Dittmann · R. W. · Flamarique · I. · Hoekstra · P. J. · Llorente · C. · Purper-Ouakil · D. · Schulze · U. · Zuddas · A. · Parnell · N. · Mohan · M. · Fiori · F
Objectives

As part of the ‘Suicidality: Treatment Occurring in Paediatrics (STOP)’ study, we developed and performed psychometric validation of an electronic-clinical-outcome-assessment (eCOA), which included a patient-reported-outcome (ePRO), an observer-rated-outcome (eObsRO) for parents/carers and a clinician-reported-outcome (eClinRO) that allows identification and monitoring of medication-related suicidality (MRS) in adolescents.

Design

STOP: Prospective study: A two phase validation study to assess the impact of medication on suicidal ideations.

Setting

Six participating countries: Netherlands, UK, Germany, France, Spain and Italy that were part of the Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 261411.

Participants

Cohort 1 consisted of 41 adolescent-completions, 50 parent-completions and 56 clinician-completions. Cohort 2 consisted of 244 adolescent-completions, 198 parent-completions and 240 clinician-completions from across the six countries. The scale was administered only to participants who have screened positive for the STOP-Suicidality Assessment Scale (STOP-SAS).

Results

A total of 24 items for the development of the STOP-Medication Suicidality Side Effects Scale (STOP-MS3) were identified and three versions (for patients, parents and clinicians) of the STOP-MS3 were developed and validated in two separate study cohorts comprising of adolescents, their parents and clinicians. Cronbach’s α coefficients were above 0.85 for all domains. The inter-rater reliability of the STOP-MS3 was good and significant for the adolescent (ePRO), clinician (eClinRO) (r=0.613), parent (eObsRO) versions of the scale (r=0.394) and parent and clinician (r=0.347). Exploratory factor analysis identified a 3-factor model across 24 items for the adolescent and parent version of the scale: (1) Emotional Dysregulation, (2) Somatic Dysregulation and (3) Behavioural Dysregulation. For the clinician version, a 4-factor model defined the scale structure: (1) Somatic Dysregulation, (2) Emotional Dysregulation, (3) Behavioural Dysregulation and (4) Mood Dysregulation.

Conclusion

These findings suggest that the STOP-MS3 scale, a web-based eCOA, allows identification and monitoring of MRS in the adolescent population and shows good reliability and validity.

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.

Cohort profile: the Pregnancy Risk Infant Surveillance and Measurement Alliance (PRISMA) - Pakistan

Por: Naz · S. · Jaffar · A. · Yazdani · N. · Kashif · M. · Hussain · Z. · Khan · U. · Farooq · F. · Nisar · M. I. · Jehan · F. · Smith · E. · Hoodbhoy · Z.
Purpose

Pakistan has disproportionately high maternal and neonatal morbidity and mortality. There is a lack of detailed, population-representative data to provide evidence for risk factors, morbidities and mortality among pregnant women and their newborns. The Pregnancy Risk, Infant Surveillance and Measurement Alliance (PRISMA) is a multicountry open cohort that aims to collect high-dimensional, standardised data across five South Asian and African countries for estimating risk and developing innovative strategies to optimise pregnancy outcomes for mothers and their newborns. This study presents the baseline maternal and neonatal characteristics of the Pakistan site occurring prior to the launch of a multisite, harmonised protocol.

Participants

PRISMA Pakistan study is being conducted at two periurban field sites in Karachi, Pakistan. These sites have primary healthcare clinics where pregnant women and their newborns are followed during the antenatal, intrapartum and postnatal periods up to 1 year after delivery. All encounters are captured electronically through a custom-built Android application. A total of 3731 pregnant women with a mean age of 26.6±5.8 years at the time of pregnancy with neonatal outcomes between January 2021 and August 2022 serve as a baseline for the PRISMA Pakistan study.

Findings to date

In this cohort, live births accounted for the majority of pregnancy outcomes (92%, n=3478), followed by miscarriages/abortions (5.5%, n=205) and stillbirths (2.6%, n=98). Twenty-two per cent of women (n=786) delivered at home. One out of every four neonates was low birth weight (

Future plans

The PRISMA cohort will provide data-driven insights to prioritise and design interventions to improve maternal and neonatal outcomes in low-resource regions.

Trial registration number

NCT05904145.

Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol

Por: De Oliveira Ascef · B. · Gabriel · F. C. · Suzumura · E. A. · Maia · F. H. d. A. · Bortoluzzi · A. F. R. · Farias · N. S. · Jahn · B. · Siebert · U. · De Soarez · P. C.
Background

Benefit–risk assessment (BRA) is used in multiple phases along the health technology’s life-cycle to evaluate the balance between the benefits and risks, as it is fundamental to all stakeholders. BRA and its methodological approaches have been applied primarily in the context of regulatory agencies. However, BRA’s application and extent in the context of health technology assessment (HTA) bodies remain less clear. Our goal is to perform a scoping review to identify and map methodological guidelines and publications on methods of BRA. This will be done considering the different phases of the life-cycle of health technologies to underline both the depth and extent of research concerning BRA, especially in the context of HTA.

Methods and analysis

This scoping review protocol was developed following the framework proposed by Arksey and O’Malley, and the updated guidelines by the Joanna Briggs Institute. We will include methodological publications that provide recommendations or guidelines on methods for BRA. We will conduct electronic searches on Medline (PubMed) and EMBASE (Ovid) databases; manual searches on the main websites of HTA bodies and drug regulatory organisations; and contact experts in the field. Systematic extraction forms will be used to screen and assess the identified publications by independent assessors. We will provide a qualitative synthesis using descriptive statistics and visual tools. Results will be summarised in systematic evidence tables and comparative evidence scoping charts.

Ethics and dissemination

This review will use data publicly available and does not require ethics approval. The results of this scoping review will contribute to scientific knowledge and act as a basis for methodologists, guideline developers and researchers for the development of BRA to inform regulatory decisions, reimbursement and coverage decision making. The results will be disseminated through peer-reviewed articles, conferences, policy briefs and workshops.

Trial registration number

Open Science Framework (https://doi.org/10.17605/OSF.IO/69T3V).

Hidden sodium in effervescent-tablet dietary supplements and over-the-counter drugs: a comparative cross-sectional study

Por: Kunz · M. · Götzinger · F. · Jacobs · C. M. · Lauder · L. · Ukena · C. · Meyer · M. R. · Laufs · U. · Schulz · M. · Böhm · M. · Mahfoud · F.
Objective

Dietary sodium intake represents a risk factor for cardiovascular disease and mortality. The study sought to analyse the sodium content of effervescent dietary supplements and drugs in Germany and the USA.

Design

Comparative cross-sectional study.

Setting and methods

The sodium content of 39 dietary supplement effervescent tablets available in Germany was measured in May and June 2022 using optical emission spectrometry with inductively coupled argon plasma. The sodium content of 33 common pharmacy-only effervescent tablets (over-the-counter (OTC) drugs) in Germany was obtained from the summary of product characteristics. We compared the sodium content of the measured German dietary supplement effervescent tablets to that of 51 dietary supplement effervescent tablets available in the USA (data: National Institutes of Health’s Dietary Supplement Label Database).

Results

The measured sodium content in the German dietary supplements was 283.9±122.6 mg sodium/tablet, equivalent to 14±6% of the maximum recommended daily sodium intake (MRDSI). Vitamin products had the highest (378.3±112.8 mg, 19±6% of MRDSI), and calcium products had the lowest mean sodium content (170.4±113.2 mg, 9±6% of MRDSI). Vitamin products contained significantly more sodium than magnesium (378.3 mg vs 232.7 mg; p=0.004), calcium (378.3 mg vs 170.4 mg; p=0.006) and mineral products (378.3 mg vs 191.6 mg; p=0.048). The sodium content measured in products available in Germany was higher when compared with the declared sodium content on the label of the products sold in the USA (283.9 mg vs 190.0 mg; p

Conclusion

Effervescent tablets of nutritional supplements and OTC drugs contain high amounts of sodium, which often is not disclosed.

Implementation and the effects of a Parkinson Network Therapy (PaNTher) on activities of daily living and health-related quality of life in Parkinsons disease patients: study protocol of an mixed-method observational cohort study in outpatient care

Por: Loidl · V. · Ziegler · K. · Hoppmann · D. · Wagner · C. · Fietzek · U. M. · Ceballos-Baumann · A. O. · Grill · E.
Introduction

Parkinson’s disease (PD) represents the fastest growing neurodegenerative disease with an increasing prevalence worldwide. It is characterised by complex motor and non-motor symptoms that lead to considerable disability. Specialised physiotherapy has been shown to benefit patients with PD. The Parkinson Netzwerk Therapie (PaNTher) was created to improve access to specialised physiotherapy tailored to care priorities of PD patients. This study aims to evaluate the effectiveness, acceptability and needs of the PaNTher network by neurologists and physiotherapists involved in the network in outpatient care.

Methods and analysis

This is a mixed-method, prospective, pragmatic non-randomised cohort study of parallel groups, with data collection taking place in Bavaria, Germany, between 2020 and 2024. Patients with PD insured by the Allgemeine Ortskrankenkasse Bayern (AOK Bayern) living in Bavaria will be recruited for study participation by network partners. Patients in the intervention group must reside in Munich or the surrounding area to ensure provision of specialised physiotherapy in close proximity to their place of residence. Controls receive care as usual. Six and 12 months after baseline, all patients receive a follow-up questionnaire. Mixed-effect regression models will be used to examine changes in impairment of activities of daily living and quality of life of patients with PD enrolled in the programme over time compared with usual care. Qualitative interviews will investigate the implementation processes and acceptability of the PaNTher network among neurologists and physiotherapists. The study is expected to show that the PaNTher network with an integrative care approach will improve the quality and effectiveness of the management and treatment of patients with PD.

Ethics and dissemination

The study has been approved by the ethics committee at the medical faculty of the Ludwig-Maximilians-University Munich (20-318). Results will be published in scientific, peer-reviewed journals and presented at national and international conferences.

Clinical staging across eating disorders: a scoping review protocol

Por: Hyam · L. E. · Phillips · M. · Gracie · L. · Allen · K. · Schmidt · U.
Introduction

Clinical staging models in psychiatry assert that there are earlier, less severe or more malleable forms of illness that are distinguishable from later, more chronic forms of illness, and that these stages may have different prognostic and treatment implications. Previous reviews on clinical staging in eating disorders (EDs) suggest a staging heuristic could be useful for anorexia nervosa, but less research is available on how this applies to other EDs. An up-to-date review is required to synthesise new and heterogenous avenues of research. This scoping review aims to explore the extent and types of evidence in relation to illness staging for EDs and how these concepts are associated with treatment response and outcomes.

Methods and analysis

This protocol was developed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol extension for Scoping Reviews checklist and the Joanna Briggs Institute Reviewer’s Manual. We will consider any documents providing evidence for clinical staging such as those which describe full or partial staging models, for all EDs, across various domains of assessment and functioning. Participants will include clinical or non-clinical population samples with full-syndrome EDs or disordered eating behaviour. PubMed, PsycINFO, MEDLINE and Web of Science databases will be systematically searched for relevant literature. Two authors will export documents and screen titles, abstracts and full texts. Data will be extracted into a charting form drafted by the authors. A narrative summary of the documents will be conducted in line with the study aims. Finally, clinical and research recommendations will be outlined.

Ethics and dissemination

Ethical approval will not be required to synthesise published and unpublished literature. The study will be published in a peer-reviewed journal and shared at conferences, via social media, and in other communications.

Are pharmacists on the front lines of the opioid epidemic? A cross-sectional study of the practices and competencies of community and hospital pharmacists in Punjab, Pakistan

Por: Mubarak · N. · Zahid · T. · Rana · F. R. · Ijaz · U.-E.-B. · Shabbir · A. · Manzoor · M. · Khan · N. · Arif · M. · Naeem · M. M. · Kanwal · S. · Saif-ur-Rehman · N. · Zin · C. S. · Mahmood · K. · Asgher · J. · Elnaem · M. H.
Introduction

Countries are grappling with a rapidly worsening upsurge in the opioid-related overdose deaths, misuse and abuse. There is a dearth of data in Pakistan regarding the practices and competencies of pharmacists in handling opioid-related issues.

Study design

A cross-sectional study, conducted across Punjab, Pakistan.

Method

The study deployed a validated survey to evaluate the competencies and practices of the community and hospital pharmacists.

Results

504 community pharmacists and 279 hospital pharmacists participated in the survey with an overall response rate of 85.5%. Almost half of the respondents ‘never’ or ‘sometimes’ made clinical notes in a journal or dispensing software to monitor ongoing opioid use. Generally, pharmacists were reluctant to collaborate with physicians or notify police regarding the abuse/misuse of opioids. Hospital pharmacists achieved significantly higher mean competency scores than chain and independent community pharmacists (p

Conclusion

Both community and hospital pharmacists hold significant positions and potential to contribute meaningfully to the mitigation of harms and risks associated with opioids. Nevertheless, this study underscores notable deficiencies in the competence of pharmacists, whether in hospital or community settings in Punjab, concerning various aspects related to the dispensing and utilisation of opioids. It also highlights the pressing need for the development of strategies aimed at improving several practice areas including the documentation, the quality of patient counselling, the effectiveness of reporting mechanisms for opioid abuse and the stringent enforcement of regulatory policies to curtail opioid misuse. Thus, to mitigate the opioid epidemic in Pakistan, it is imperative to institute opioid stewardship initiatives aimed at rectifying the competency and procedural deficiencies within the pharmacist workforce.

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