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Protocol for the development of a tool (INSPECT-SR) to identify problematic randomised controlled trials in systematic reviews of health interventions

Por: Wilkinson · J. · Heal · C. · Antoniou · G. A. · Flemyng · E. · Alfirevic · Z. · Avenell · A. · Barbour · G. · Brown · N. J. L. · Carlisle · J. · Clarke · M. · Dicker · P. · Dumville · J. C. · Grey · A. · Grohmann · S. · Gurrin · L. · Hayden · J. A. · Heathers · J. · Hunter · K. E. · Lasser
Introduction

Randomised controlled trials (RCTs) inform healthcare decisions. It is now apparent that some published RCTs contain false data and some appear to have been entirely fabricated. Systematic reviews are performed to identify and synthesise all RCTs that have been conducted on a given topic. While it is usual to assess methodological features of the RCTs in the process of undertaking a systematic review, it is not usual to consider whether the RCTs contain false data. Studies containing false data therefore go unnoticed and contribute to systematic review conclusions. The INveStigating ProblEmatic Clinical Trials in Systematic Reviews (INSPECT-SR) project will develop a tool to assess the trustworthiness of RCTs in systematic reviews of healthcare-related interventions.

Methods and analysis

The INSPECT-SR tool will be developed using expert consensus in combination with empirical evidence, over five stages: (1) a survey of experts to assemble a comprehensive list of checks for detecting problematic RCTs, (2) an evaluation of the feasibility and impact of applying the checks to systematic reviews, (3) a Delphi survey to determine which of the checks are supported by expert consensus, culminating in, (4) a consensus meeting to select checks to be included in a draft tool and to determine its format and (5) prospective testing of the draft tool in the production of new health systematic reviews, to allow refinement based on user feedback. We anticipate that the INSPECT-SR tool will help researchers to identify problematic studies and will help patients by protecting them from the influence of false data on their healthcare.

Ethics and dissemination

The University of Manchester ethics decision tool was used, and this returned the result that ethical approval was not required for this project (30 September 2022), which incorporates secondary research and surveys of professionals about subjects relating to their expertise. Informed consent will be obtained from all survey participants. All results will be published as open-access articles. The final tool will be made freely available.

Economic burden of adverse perinatal outcomes from births to age 5 years in high-income settings: a protocol for a systematic review

Por: Haile · T. G. · Pereira · G. · Norman · R. · Tessema · G. A.
Background

Adverse perinatal outcomes such as preterm, small for gestational age, low birth weight, congenital anomalies, stillbirth and neonatal death have devastating impacts on individuals, families and societies, with significant lifelong health implications. Despite extensive knowledge of the significant and lifelong health implications of adverse perinatal outcomes, information on the economic burden is limited. Estimating this burden will be crucial for designing cost-effective interventions to reduce perinatal morbidity and mortality. Thus, we will quantify the economic burden of adverse perinatal outcomes from births to age 5 years in high-income countries.

Methods and analysis

A systematic review of all primary studies published in English in peer-reviewed journals on the economic burden for at least one of the adverse perinatal outcomes in high-income countries from 2010 will be searched in databases—MEDLINE (Ovid), EconLit, CINAHL (EBSCO), Embase (Ovid) and Global Health (Ovid). We will also search using Google Scholar and snowballing of the references list of included articles. The search terms will include three main concepts—costs, adverse perinatal outcome(s) and settings. We will use the Consolidated Health Economics Evaluation Reporting Standards 2022 and 17 criteria from the critical appraisal of cost-of-illness studies to assess the quality of each study. We will report the findings based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses 2020 statement. Costs will be converted into a common currency (US dollar), and we will estimate the pooled cost and subgroup analysis will be done. The reference lists of included papers will be reviewed.

Ethics and dissemination

This systematic review will not involve human participants and requires no ethical approval. The results of this review will be published in a peer-reviewed journal.

PROSPERO registration number

CRD42023400215.

Determining the feasibility of a codesigned and personalised intervention (Veg4Me) to improve vegetable intake in young adults living in rural Australian communities: protocol for a randomised controlled trial

Por: Livingstone · K. M. · Rawstorn · J. C. · Partridge · S. R. · Zhang · Y. · O · E. · Godrich · S. L. · McNaughton · S. A. · Hendrie · G. A. · Dullaghan · K. · Abbott · G. · Blekkenhorst · L. C. · Maddison · R. · Barnett · S. · Mathers · J. C. · Alston · L.
Introduction

Diets low in vegetables are a main contributor to the health burden experienced by young adults in rural communities. Digital health interventions provide an accessible delivery model that can be personalised to meet the diverse preferences of young adults. A personalisable digital vegetable intake intervention (Veg4Me) was codesigned to meet the needs of young adults living in rural communities. This study will determine the feasibility of delivering a personalised Veg4Me programme and compare preliminary effects with a non-personalised Veg4Me (control).

Methods and analysis

A 12-week assessor-blinded, two-arm, parallel randomised controlled trial will be undertaken from August 2023 until April 2024. A total of 150 eligible and consenting young adults (18–35 years; eat

Ethics and dissemination

All procedures involving human subjects were approved by Deakin University’s Human Ethics Advisory Group—Health (HEAG-H 06_2023) on 6 March 2023. Dissemination events will be held in the City of Greater Bendigo and the Colac Otway Shire. Summaries of the results will be disseminated to participants via email. Results will be disseminated to the scientific community through peer-reviewed publications and conference presentations.

Trial registration number

Australia New Zealand Clinical Trials Registry, ACTRN12623000179639p, prospectively registered on 21 February 2023, according to the World Health Organizational Trial Registration Data Set. Universal Trial Number U1111-1284-9027.

Gap analysis of service quality and associated factors at the oncology center of Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia, 2022: a cross-sectional study

Por: Wasihun · G. A. · Addise · M. · Nega · A. · Kifle · A. · Taye · G. · Gebrekidan · A. Y.
Objective

To measure the gap between expectations of patients with cancer for oncology services and their perceptions of the actual service and to identify associated factors at the oncology centre of Tikur Anbessa Specialized Hospital, Ethiopia.

Design

An institutional-based cross-sectional study design was conducted using the service quality (SERVQUAL) tool from March to April 2022 on a sample of 256 hospitalised patients with cancer at the oncology centre of Tikur Anbessa Specialized Hospital. A paired Wilcoxon test and Kruskal-Wallis tests were used to determine the statistically significant difference between expectation and perception and to quantify the strength of association between the level of gap in the quality of oncology service and dependent variables, respectively.

Results

Out of 256 patients with cancer included in the study, all of them agreed and participated, making the response rate 100%. The overall gap in service quality explained by the mean and SD is –1.42 (±0.41). The overall score for expectation and perception is 4.24 (±0.31) and 2.82 (±0.37), respectively. Being female, age greater than 65, having a college degree and above, being a patient with cervical cancer, patients with stage 4 cancer and patients who waited for more than 12 months for radiotherapy were found to have a statistically significant higher expectation compared with their perceived care in one or more dimensions of the SERVQUAL tool.

Conclusion

Patient perceptions of the quality of service they received were lower than their expectations of the quality of service in all service quality aspects at Tikur Anbessa Specialized Hospital’s oncology centre, implying unmet quality expectations from the oncology service users, with tangibility, assurance and empathy being the dimensions with the highest gap recorded, respectively. Therefore, the hospital and other stakeholders should strive to exceed patient expectations and the overall quality of care.

Intended changes in smoking behaviour of Dutch young adults after an increase in excise tax: a cross-sectional survey

Por: Visscher · K. · Everaars · B. · Suijkerbuijk · A. W. · Lambooij · M. · de Wit · G. A.
Objectives

Increasing the price of tobacco is one of the most effective measures to reduce the prevalence of smoking. In the Netherlands, the excise tax on tobacco increased by 1.14 in 2020, raising the price of a standard package of cigarettes to 8.00. This study investigates how young adults intend to change their smoking behaviour in the case of hypothetical price increases of a pack of cigarettes, and which background characteristics are associated with intended behaviour change.

Design

A cross-sectional online survey was carried out between September and November 2020. Smokers indicated how they would react to several hypothetical increases in price. Four behavioural options were investigated: smoking less, quitting smoking, switching to another/cheaper product and buying cheaper cigarettes cross-border.

Participants

Data were obtained from 776 Dutch smokers between 15 and 25 years.

Results

At a hypothetical price of 10 per package, most respondents reported an intention to smoke less (67%), followed by switching to another/cheaper product (61%), quitting smoking (49%) and shopping for cigarettes cross-border (47%). Prior quit attempts, agreeing with the increase in excise tax and the intention to quit smoking in the future increased the odds of changing behaviour. Higher self-efficacy decreased the odds of behavioural change.

Conclusion

Many young adults intend to change their smoking behaviour in the event of increased prices. Although intended behaviour can deviate significantly from actual behaviour, an increase in excise tax may result in a significant amount of quit attempts and reduced smoking among young adults.

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.

Development of indicators for avoidable emergency medical service calls by mapping paramedic clinical impression codes to ambulatory care sensitive conditions and mental health conditions in the UK and Canada

Por: Agarwal · G. · Siriwardena · A. N. · McLeod · B. · Spaight · R. · Whitley · G. A. · Ferron · R. · Pirrie · M. · Angeles · R. · Moore · H. · Gussy · M. · EDGE Consortium · Agarwal · Siriwardena · Angeles · Bielska · Brar · Cooper · Ferron · Gussy · Hill · Khunti · Law · McLeod · Moore · P
Objective

Paramedic assessment data have not been used for research on avoidable calls. Paramedic impression codes are designated by paramedics on responding to a 911/999 medical emergency after an assessment of the presenting condition. Ambulatory care sensitive conditions (ACSCs) are non-acute health conditions not needing hospital admission when properly managed. This study aimed to map the paramedic impression codes to ACSCs and mental health conditions for use in future research on avoidable 911/999 calls.

Design

Mapping paramedic impression codes to existing definitions of ACSCs and mental health conditions.

Setting

East Midlands Region, UK and Southern Ontario, Canada.

Participants

Expert panel from the UK-Canada Emergency Calls Data analysis and GEospatial mapping (EDGE) Consortium.

Results

Mapping was iterative first identifying the common ACSCs shared between the two countries then identifying the respective clinical impression codes for each country that mapped to those shared ACSCs as well as to mental health conditions. Experts from the UK-Canada EDGE Consortium contributed to both phases and were able to independently match the codes and then compare results. Clinical impression codes for paramedics in the UK were more extensive than those in Ontario. The mapping revealed some interesting inconsistencies between paramedic impression codes but also demonstrated that it was possible.

Conclusion

This is an important first step in determining the number of ASCSs and mental health conditions that paramedics attend to, and in examining the clinical pathways of these individuals across the health system. This work lays the foundation for international comparative health services research on integrated pathways in primary care and emergency medical services.

Roles, mutual expectations and needs for improvement in the care of residents with (a risk of) dehydration: A qualitative study

Abstract

Aim

Examining the perspectives of formal and informal caregivers and residents on roles, mutual expectations and needs for improvement in the care for residents with (a risk of) dehydration.

Design

Qualitative study.

Methods

Semi-structured interviews with 16 care professionals, three residents and three informal caregivers were conducted between October and November 2021. A thematic analysis was performed on the interviews.

Results

Three topic summaries contributed to a comprehensive view on the care for residents with (a risk of) dehydration: role content, mutual expectations and needs for improvement. Many overlapping activities were found among care professionals, informal caregivers and allied care staff. While nursing staff and informal caregivers are essential in observing changes in the health status of residents, and medical staff in diagnosing and treating dehydration, the role of residents remains limited. Conflicting expectations emerged regarding, for example, the level of involvement of the resident and communication. Barriers to multidisciplinary collaboration were highlighted, including little structural involvement of allied care staff, limited insight into each other's expertise and poor communication between formal and informal caregivers. Seven areas for improvement emerged: awareness, resident profile, knowledge and expertise, treatment, monitoring and tools, working conditions and multidisciplinary working.

Conclusion

In general, many formal and informal caregivers are involved in the care of residents with (a risk of) dehydration. They depend on each other's observations, information and expertise which requires an interprofessional approach with specific attention to adequate prevention. For this, educational interventions focused on hydration care should be a core element in professional development programs of nursing homes and vocational training of future care professionals.

Impact

The care for residents with (a risk of) dehydration has multiple points for improvement. To be able to adequately address dehydration, it is essential for formal and informal caregivers and residents to address these barriers in clinical practice.

Reporting Method

In writing this manuscript, the EQUATOR guidelines (reporting method SRQR) have been adhered to.

Patient or Public Contribution

No patient or public contribution.

Optimising scale-up for public health impact: a multimethod implementation science research protocol to improve infant health outcomes in Ethiopia

Por: Hakizimana · D. · Shitu · K. · Rankin · K. C. · Alemie · G. A. · Walson · J. · Guthrie · B. L. · Means · A. R.
Introduction

Child mortality rates remain high in sub-Saharan Africa, including Ethiopia. We are conducting a cluster randomised control trial in the Gondar zone of the Amhara region to determine the impact of pairing Orthodox priests with community health workers, known locally as the Health Development Army (HDA), on newborns’ nutritional status, early illness identification and treatment, and vaccination completeness.

Ensuring intervention efficacy with scientific rigour is essential, but there are often delays in adopting evidence into policy and programmes. Here, we present a protocol for conducting parallel implementation research alongside an efficacy study to understand intervention implementability and scalability. This will help develop a scale-up strategy for effective elements of the intervention to ensure rapid implementation at scale.

Methods and analysis

We will conduct a stakeholder analysis of key implementation stakeholders and readiness surveys to assess their readiness to scale up the intervention. We will conduct semistructured interviews and focus group discussions with stakeholders, including HDA members, health workers, Orthodox priests, and caregivers, to determine the core intervention elements that need to be scaled, barriers and facilitators to scaling up the intervention in diverse sociocultural settings, as well as the human and technical requirements for national and regional implementation. Finally, to determine the financial resources necessary for sustaining and scaling the intervention, we will conduct activity-based costing to estimate implementation costs from the provider’s perspective.

Ethics and dissemination

The study received approval from the University of Gondar Institutional Review Board (approval no: VP/RTT/05/1030/2022) and the University of Washington Human Subjects Division (approval no: STUDY00015369). Participants will consent to participate. Results will be disseminated through workshops with stakeholders, local community meetings, presentations at local and international conferences, and journal publications. The study will provide evidence for factors to consider in developing a scale-up strategy to integrate the intervention into routine health system practices.

Maternal near-miss prediction model development among pregnant women in Bahir Dar City administration, northwest Ethiopia: a study protocol

Por: Workineh · Y. · Alene · G. D. · Fekadu · G. A.
Introduction

Maternal near-miss is a condition when a woman nearly died but survived from complications that happened during pregnancy, childbirth or within 42 days after delivery. Maternal near-miss is more prevalent among women in developing nations. Previous studies have identified the impact of different predictor variables on maternal near-miss but shared prognostic predictors are not adequately explored in Ethiopia. It is therefore necessary to build a clinical prediction model for maternal near-misses in Ethiopia. Hence, the aim of this study is to develop and validate a prognostic prediction model, and generate a risk score for maternal near-miss among pregnant women in Bahir Dar City Administration.

Methods and analysis

A prospective follow-up study design will be employed among 2110 selected pregnant women in the Bahir Dar City administration from 1 May 2023 to 1 April 2024. At the initial antenatal visit, pregnant women will be systematically selected. Then, they will be followed until 42 days following birth. Data will be collected using structured questionnaires and data extraction sheet. The model will be created using Cox proportional hazard regression analysis. The performance of the model will be assessed based on its capacity for discrimination using c-index and calibration using calibration plot, intercept and slope. The model’s internal validity will be evaluated through the bootstrapping method. Ultimately, the model will be illustrated through a nomogram and decision tree, which will be made available to prospective users.

Ethics and dissemination

Ethical approval has been obtained from the Institutional Review Board of the College of Medicine and Health Sciences, Bahir Dar University (protocol number 704/2023). Findings will be published in peer-reviewed journals and local and international seminars, conferences, symposiums and workshops. Manuscripts will be prepared and published in scientifically reputable journals. In addition, policy briefs will be prepared.

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