bluuebunny/crossref_metadata_2025 huggingface dataset:
128: THE EFFECT OF INTRAMUSCULAR HYOSCINE AND HYOSCINE-PROMETHAZINE ON THE DURATION OF LABOR IN NULLIPAROUS PREGNANT WOMEN (TRIPLE-BLIND RANDOMIZED CONTROLLED TRIAL)
Authors: Shafahi Fahimeh Sehhatie , Shahmohammadi Farzeneh , Khanmohammadi Fatemeh , Jaffarabadi Mohamad Ashari
Published: May 2024

Background and aims:

Improvement of maternal healthiness and decreasing maternal mortality and morbidity is one of important anxieties in the world. One of the factors that influence intensity of pain is duration of labor. In other words, increasing intensity of pain affects duration of labor. This study survey the effect of intramuscular Hyoscine and Hyoscine-Promethazine on the duration of labor in nulliparous pregnant women.

Methods:

This study was three blind clinical trials on 213 nulliparous pregnant women who have referred to Amiralmomenin hospital in Zanjan. Selection of samples was random and done with Rand List software and used 3, 6 (1:1:1) of blocking size. This study had 3 groups. First group received 20 mg Hyoscine(A), second group 20mg Hyoscine and 25mg Promethazine(B) and third group 3cc sterile water(C). Data collection tools were including of a demographic questionnaire, checklist of data and Partograph chart. Analysis of data done by SPSS (ver16) and Anova (tukey) and chi-square test.

Results:

Means of first stage of labor in Hyoscine group was 88.95±51.07 min, Hyoscine-Promethazine 100.05±65.88 min and control group 170.37±106.87 min. there is significant correlation between A,C and B, C groups (p<0.001). second stage means in group A was 46.37±44.60, group B 32.25±17.74 and control group 55.05±44.44 and significant relationship was between B,C groups(p=0.03) . In third stage no significant difference observed between groups (p=0.105).

Conclusion:

Sometimes and in some urgency cases, for decreasing duration of labor, we can use Hyoscine and Hyoscine-Promethazine.
150: USING EVIDENCE-BASED EDUCATION: A NECESSARY APPROACH IN THE PREVENTION OF EMERGING DISEASES CRIMEAN CONGO
Authors: atri Shirin Barzanjeh , Ranjbar Fatemeh , Sahebihag Mohammad hasan , Jafarabadi Mohammad Asgari , Vahedi Pedram , Balafar Molood , Keyhaniazar Elham
Published: May 2024

Background and aims:

Evidence-based education, integrating professional knowledge of current best evidence in making decisions about how to deliver the training. Using traditional methods of teaching can bring learning to deviate so the use of modern methods and scientific evidence crucial role in the decision-making training. The first level is placed on prevention education and Special education for at-risk groups on ways to control and prevent emerging diseases Crimean-Congo With 30 percent lethality is needed.

Methods:

The review of the literature between 2000 and 2016, with a focus on evidence-based education, traditional education, emerging diseases, prevention and Crimean-Congo in databases scholar Google, PubMed, Cochrane, Sid and Magiran results of applying slightly different methods training in the prevention of emerging diseases Crimean-Congo there.

Results:

The findings, few studies in educating in relation to Crimean – Congo show. The results of the study Sargolzaee (1392) as “the Crimean-Congo hemorrhagic fever surveillance system and general practitioners city of Zahedan, showed that doctors who spend history retraining program. The Congolese disease is more likely than other medical information. But the result of the use of evidence-based teaching methods in the prevention of emerging diseases Crimean-Congo, was not found.

Conclusion:

The literature review shows that education as an important way to prevent the disease, Crimean-Congo is emerging. The Aforementioned points show, identify and adopt appropriate measures, including evidence-based education in the prevention of disease, Crimean-Congo strongly felt.
180: IDENTIFYING ELECTRONIC HEALTH LITERACY LEVEL IN ADULT PATIENTS: AN IRANIAN EXPERIENCE
Authors: Valizadeh-Haghi Saeedeh , Seifi Leili
Published: May 2024

Background and aims:

Many people use the internet for healthcare information worldwide. But collecting information through the internet is different from other media and there is a gap between the electronic health resources available and consumers' skills for using them. Thus by growing Internet and its impact, computer and Internet literacy are becoming important skills for users. Therefore, E-Health literacy should be measured to get a comprehensive overview of people's skills to obtain and use health information. The aim of our study was to identify the level of electronic health literacy in adult patients which refer to dental clinics. This is especially important for patients with dental health care needs who requires to make decisions about various dental treatment plans. Yet, no information is available about this group.

Methods:

This was a descriptive-analytical cross sectional study. The method used was Convenience sampling and the population of study were 267 patients referred to the Sepehr dental clinic from May to June. The E-Health Literacy Scale (E-HEALS) was used to measure E-Health literacy. Descriptive analyses were conducted to address the study objectives.

Results:

The study revealed that most of the patients are low electronic health literate and it is needed to make improvement of patients' skills in internet resources use. Female patients use internet for health reasons more than male patients. Furthermore, the female patients are more literate than male patients.

Conclusion:

Exploring a patient's HL levels may provide a better understanding of the patient's potential barriers to self-management of dental diseases and health-promoting behaviours.
67: FABRICATION OF SMART SELF-EXPANDING BIOCOMPATIBLE STENTS IN BODY TEMPERATURE
Authors: Shirsavar Mehran Abbasi , Golzar Mohammad , Baghani Mostafa , Taghavimehr Mehrnoosh
Published: May 2024

Stent implantation has attracted significant attention since the urgent need of coronary angioplasty as the most common cause of heart attacks. Shape memory materials are able to have two shapes at different conditions. Since the smart materials are self-expandable, the presence of the balloon in stents eliminates due its problems like designing, material properties and dimension of balloons. In this study, we focused on shape memory polymers which have lots of advantages in comparison with shape memory alloys such as high elastic deformation, excellent processability, light weight, low cost, low density, and potential of biocompatibility so they have become a proper candidate for implant materials. It has been found that mechanical properties of polymeric materials can be improved by introducing a uniform dispersion of nanoparticles. The main goal of this paper is to describe the progressive self-expansion shape memory Polyurethane/Polycaprolactane-ZnO nano-composite blends. Fabrication of self-expanding stents and applying them in body temperature conditions will be discussed in details.
7: A SYSTEMATIC REVIEW ON VITAMIN D AND ANGIOGENESIS
Authors: Aliashrafi Soodabeh , Ebrahimi-Mameghani Mehrangiz
Published: May 2024

Background and aims:

Angiogenesis is the process of new blood vessel sprouting from the existing vasculature. It is physiologically present during wound healing, development of placenta, tissue growth and adipogenesis as well as playing role in pathological processes such as tumor growth, metastasis, obesity and non-alcoholic fatty liver disease (NAFLD). Angiogenesis therapy is as a Strategy for treatment of some diseases. The angiogenic process is regulated by numerous factors e.g. dietary factors. In this paper, we reviewed available documents and research relevant to vitamin D and angiogenesis.

Methods:

A systematic review of recent literature was conducted using the PRISMA guidelines. The sources of the data were PubMed, Google Scholar, Cochrane, Web of Science and Scopus. Key search terms were “Angiogenesis”, “Angiogenesis factor”, “vitamin D”, “1,25 (OH)2D3” and “Calciteriol”. Articles included in the review were original research articles in peer-reviewed journals which thoroughly examined and compared on the basis of study design, outcomes, and results.

Results:

The effect of vitamin D on angiogenesis was first reported in 1990. Evidence from current studies supports anti-angiogenesis and pro-angiogenesis effects of the 1, 25 (OH)2D3in several invivoandin vitrostudies. Results from recent studies implies that different effects of 1, 25 (OH)2D3on angiogenesis depends on the cellular types, cellular condition and type of chemokines released from the tissue. In cells with excessive angiogenesis, vitamin D addition results in decreased angiogenesis through reducing the activation, proliferation, migration, germination of endothelial cells whereas in the absence of vascular injury, vitamin D increases hypoxia-inducible factor 1-α (HIF1-α) and promoted Stromal Cell–Derived Factor 1 (SDF1) expression subsequently mediated vascular repair.

Conclusion:

Current literature suggests that Vitamin D has anti-angiogenic and pro- angiogenic effects. There is currently insufficient evidence about main and direct effect of vitamin D on angiogenesis. Further studies are needed to investigate the dominant role and different doses of vitamin D on Angiogenesis.
73: HOSPITAL EMERGENCY RESPONSE AGAINST DISASTERS: EVIDENCE FROM HOSPITALS IN IRAN
Authors: Janati Ali , Sadeghi-bazargani Homayoun , Hasanpoor Edris , Sokhanvar Mobin , HaghGoshyie Elaheh
Published: May 2024

Background and aims:

Hospitals play a critical role in providing communities with essential medical care during all types of disaster. Hospital emergency management is a continuing process requiring the monolithic integration of planning and response attempts with local and national schemes. The aim of the current study was to assess emergency response of hospitals against disasters in Tabriz.

Methods:

A cross-sectional study was conducted in Tabriz city, during 2016 in Iran. The study population included all hospitals in Tabriz city. 18 hospitals were assessed. Hospital emergency response checklist was used to collect data. Tool components including: Command and control, Communication, Safety and security, Triage, Surge capacity, Continuity of essential services, Human resources, Logistics and supply management and Post-disaster recovery. Data entry and analysis was done using SPSS-20.

Results:

The results showed that emergency response of hospitals were 54.26 percent in Tabriz. The lowest response rates were related to Shafaa hospital (18.89%) and highest response rates was related to Razi hospital (91.67%). Components of hospital emergency response were assessed between 48.07% (Surge capacity) to 58.95% (Communication).

Conclusion:

Based on WHO checklist, the only emergency response of hospitals were 54.26 percent in Tabriz. So, Hospital emergency responses against disasters have to be improved and should be 100 percent. It is essential to design a comprehensive framework for hospital emergency response.
82: INVESTIGATION OF METHODS OF ACCESS TO INFORMATION BY TONKABON RURAL WOMEN AND ITS IMPACT ON THEIR HEALTH
Authors: Mohasel Zahra Afsarion , Ghiasi Mitra , Zarei Hajar
Published: May 2024

Background and aims:

The current study is aimed at investigating the access of Tonekabon City's rural women to information and its impact on their health.

Methods:

The methodology used in this research is survey- analytical. The study population contains 42,283 rural women, residing in Tonekabon City in Mazandaran Province. Using the systematic random sampling method and the sampling formula of Kockran, the community sample numbered 297. The research tool was a questionnaire, made by the researcher. To analyze the data, the descriptive statistics (frequency table) and the interpretive statistics) mann whithney U and spearman Test) was applied.

Results:

The findings of this research indicated that watching TV was the main source of accessing the necessary health and medical information by rural women, while referring to a general practitioner came second in this regard. The main kind of medical information required by these women is related to gynecological and skin diseases. The role of internet resources and web pages in accessing medical and health information is also transparent. At the same time, a paucity of sufficient libraries and training classes along with inadequate information provided to women by health clinics in the rural areas have been among the main obstacles in the way of receiving health and medical information.Having put the hypothesis to test, it was shown that there was no meaningful difference between healthy people and patients in making use of the information recourses, with both groups favoring the resources on an equal basis. Testing the second hypothesis indicated a direct link between the education level and application of information resources.

Conclusion:

The survey findings show that not only ill people seek to gain medical and health information, but healthy people are also after receiving such necessary information. This is while those with a higher level of education pursue such information on a more frequent basis.
Do biological disease-modifying antirheumatic drugs reduce the spinal fracture risk related to ankylosing spondylitis? A longitudinal multiregistry matched cohort study
Authors: Robinson Yohan , Olerud Claes , Willander Johan
Published: May 2024

Objectives

Ankylosing spondylitis (AS) is associated with an increased spinal fracture risk due to the loss of elasticity in spinal motion segments. With the introduction of biological disease-modifying antirheumatic drug (bDMARD) treatment for AS, the individual course of the disease has been ameliorated. This study aims to examine the association of bDMARD treatment and risk of spinal fracture.

Design

Longitudinal population-based multiregistry observational matched cohort study.

Setting

Swedish Patient Registry 1987–2014 and Swedish Prescribed Drugs Registry 2005–2014.

Participants

Included were patients ≥18 years of age receiving treatment at a healthcare facility for the primary diagnosis of AS. About 1352 patients received more than one prescription of bDMARD from 2005 to 2014. An untreated control group was created by propensity score matching for age, sex, comorbidity, antirheumatic prescriptions and years with AS (n=1352).

Main outcome measures

Spinal fracture-free survival.

Results

No bDMARD treatment-related effect on spinal fracture-free survival was observed in the matched cohorts. Male gender (HR=2.54, 95% CI 1.48 to 4.36) and Charlson Comorbidity Index score (HR=3.02, 95% CI 1.59 to 5.75) contributed significantly to spinal fracture risk.

Conclusion

bDMARD had no medium-term effect on the spinal fracture-free survival in patients with AS.

Trial registration number

NCT02840695; Post-results.
Study protocol for a randomised controlled trial of Allen Carr’s Easyway programme versus Lambeth and Southwark NHS for smoking cessation
Authors: Wood Kerry V , Albery Ian P , Moss Antony C , White Sarah , Frings Daniel
Published: May 2024

Introduction

Smoking is a major cause of ill health and is associated with several diseases including cancer, coronary heart disease and stroke. Many psychological and pharmacological smoking cessation treatments are available and although they are undoubtedly the most cost-effective health interventions available, many people still fail to maintain cessation in the longer term. Recently, National Institute for Health and Care Excellence called for comparative studies to determine the short-term and long-term effectiveness of Allen Carr’s Easyway (ACE) method of stopping smoking. This study will compare the efficacy of the ACE programme and a 1–1 counselling service available via the National Health Service.

Methods and analysis

A two-arm, parallel-group, blinded, randomised controlled trial will be conducted with people who smoke tobacco cigarettes, are aged ≥18 years and are motivated to quit. Exclusion criteria comprise self-reported mental health condition, pregnancy or respiratory disease such as chronic obstructive pulmonary disease or emphysema. The primary treatment outcome is smoking cessation 26 weeks after treatment. Participants will be analysed on an intention to treat basis at the point of randomisation. Before being randomised, the research team will not inform participants which two treatments are being compared. Once randomised researchers will be blinded to participant condition, and participants will be blinded to the condition they are not assigned to. Logistic regression will be used to estimate the effectiveness of the treatment condition on smoking cessation at 26 weeks. The following covariates will be included: baseline quit efficacy (at inclusion), age (at inclusion), gender and baseline nicotine dependency.

Ethics and dissemination

Approval was granted by London–Fulham Research Ethics Committee (ref: 16/LO/1657). The study’s findings will be published in peer-reviewed journals and disseminated at national and international conferences.

Trial registration number

ClinicalTrials.gov identifier number:NCT02855255. ISRCTN registration number:ISRCTN23584477; Pre-results.
Protocol: a cluster randomised control trial study exploring stigmatisation and recovery-based perspectives regarding mental illness and substance use problems among primary healthcare providers across Toronto, Ontario
Authors: Khenti Akwatu , Mann Robert , Sapag Jaime C , Bobbili Sireesha J , Lentinello Emily K , Maas Mark van der , Agic Branka , Hamilton Hayley , Stuart Heather , Patten Scott , Sanches Marcos , Corrigan Patrick
Published: May 2024

Introduction

Primary care settings are often the first and only point of contact for persons with mental health and/or substance use problems. However, staff experience and training in this area are often limited. These factors as well as a multitude of other components such as structural and systemic stigma experienced by staff can lead to clients being stigmatised, leading to poorer outcomes. By developing a comprehensive intervention for primary care staff working at community health centres (CHCs) aimed at reducing stigma towards people with mental health and substance use problems (MHSUP), we sought to test an innovative and contact-based intervention consisting of staff training, raising awareness, a recovery-focused art programme and an analysis of internal policies and procedures. All of these components can inform and support staff so they can provide better care for people who are experiencing MHSUP. CHC staff members and clients will be included in this project as active participants.

Methods and analysis

This mixed-methods project will consist of repeated surveys of staff and clients, as well as in-depth, semistructured interviews with a sample of clients and staff. A cluster randomised control trial design will test the effectiveness of an antistigma intervention for CHCs in Toronto, Canada. Six CHCs—three receiving the intervention and three controls—will be included in the study. Using a variety of measures, including the Opening Minds Scale for Health Care Providers (OMS-HC), Mental Illness: Clinicians Attitudes (MICA) Scale, Modified Bogardus Social Distance Scale, Perceived Devaluation-Discrimination Scale, Discrimination Experience subscale of the Internalized Stigma of Mental Illness (ISMI) Scale and the Recovery Assessment Scale (RAS), we hope to gain a thorough understanding of staff members’ attitudes and beliefs and clients’ perceptions of staff beliefs and behaviours. In-depth interviews will reveal important themes related to clients’ experiences of stigma both within and outside the healthcare setting.

Ethics and dissemination

If demonstrated to be successful, this intervention can be used as a model for future initiatives aimed at reducing MHSUP-related stigma among healthcare providers in an organisational context. Adapting this work in other settings is a key strategic goal of this project. The project will also advance knowledge about stigma reduction and the experience of encountering stigma within a healthcare setting.

Trial registration

NCT03043417; Post-results.
Transforaminal lumbar interbody fusion with cortical bone trajectory screws versus traditional pedicle screws fixation: a study protocol of randomised controlled trial
Authors: Feng Zhenhua , Li Xiaobin , Tang Qian , Wang Chenggui , Zheng Wenhao , Zhang Hui , Wu Ai-Min , Tian Naifeng , Wu Yaosen , Ni Wenfei
Published: May 2024

Introduction

Transforaminal lumbar interbody fusion (TLIF) has been widely used in the treatment of lumbar degenerative disc disorders and shows favourable clinical results. Recently, cortical bone trajectory (CBT) has become a new trajectory for screw insertion in the lumbar spine. Several biomechanical studies have demonstrated that the CBT technique achieves screw purchase and strength greater than the traditional method. Currently, the available data on the clinical effectiveness of the two performed surgeries, TLIF with CBT screws (CBT-TLIF) and TLIF with traditional pedicle screws (PS-TLIF), are insufficient. This is the first randomised study to compare CBT-TLIF against traditional PS fixation and will provide recommendations for treating patients with lumbar degenerative disc disorders.

Methods and analysis

A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of 254 participants with lumbar disc degenerative disease who are candidates for TLIF surgery will be randomly allocated to either the CBT-TLIF group or the PS-TLIF group at a ratio of 1:1. The primary clinical outcome measures are the incidence of adjacent cranial facet joint violation, fusion rate and the screw loosening rate. Secondary clinical outcome measures are Visual Analogue Scale (VAS) of back pain, VAS of leg pain, Oswestry Disability Index, operative time, intraoperative blood loss and complications. These parameters will be evaluated on day 3, and then at 1, 3, 6, 12 and 24 months postoperatively.

Ethics and dissemination

This study has been reviewed and approved by the Institutional Review Board of the Second Affiliated Hospital and Yuying Children’s Hospital of Wenzhou Medical University (batch: 2017–03). The results will be presented in peer-reviewed journals and an international spine-related meeting after completion of the study.

Trial registration number

NCT03105167; Pre-results.
Effectiveness of sitagliptin compared to sulfonylureas for type 2 diabetes mellitus inadequately controlled on metformin: a systematic review and meta-analysis
Authors: Sharma Manuj , Beckley Nicholas , Nazareth Irwin , Petersen Irene
Published: May 2024

Objective

To assess the effectiveness of sitagliptin compared to sulfonylureas as add-on to metformin in adults with type 2 diabetes mellitus from both randomised controlled trials (RCTs) and ‘real-world’ non-randomised studies.

Methods and analyses

We conducted a systematic review of EMBASE, MEDLINE, CENTRAL and grey literature for RCTs and non-randomised studies. We reported outcomes relating to change in HbA1c, fasting glucose, weight, blood pressure and lipids from baseline and need for treatment change. No study investigating macrovascular and microvascular diabetes complications was found. Meta-analysis was used where studies were sufficiently homogenous.

Results

Seven RCTs and five non-randomised studies were eligible for inclusion from 1335 articles retrieved. Meta-analysis of three homogenous RCTs revealed a statistically significant decrease in weight with sitagliptin when compared to sulfonylureas (weighted mean difference (WMD) −2.05 kg; 95% CI −2.38 to −1.71); however, a similar change from baseline in HbA1c (WMD 0.05; 95% CI −0.03 to 0.12), fasting glucose (WMD 0.11; 95% CI −0.08 to –0.29), blood pressure, lipids and the proportion achieving HbA1c <7% by study end (OR 0.98; 95% CI 0.85 to 1.13) was observed.

Non-randomised studies identified consisted of four prospective and one retrospective cohort study. Three of these five studies were of moderate/high quality, and results though less precise suggested similar real-world comparative glycaemic and weight effectiveness for both treatments. Data from two cohort studies suggested that treatment change (HR 0.65; 95% CI 0.57 to 0.73) and insulin initiation (HR 0.76; 95% CI 0.65 to 0.90) were less likely among those prescribed sitagliptin; however, inadequate reporting of HbA1c at time of treatment change made interpreting results challenging.

Conclusion

Sitagliptin users experienced modest weight loss compared to gain with sulfonylureas; however, this difference was around 2 kg, which may not be of major clinical significance for most individuals. Similar change was observed across most other effectiveness outcomes reported. Further studies are needed to address longer-term effectiveness outcomes for sitagliptin compared to sulfonylureas as add-on to metformin.

PROSPERO registration number

CRD42016033983.
Effectiveness of an electronic patient-centred self-management tool for gout sufferers: a cluster randomised controlled trial protocol
Authors: Day Richard O , Frensham Lauren J , Nguyen Amy D , Baysari Melissa T , Aung Eindra , Lau Annie Y S , Zwar Nicholas , Reath Jennifer , Laba Tracey , Li Ling , McLachlan Andrew , Runciman William B , Buchbinder Rachelle , Clay-Williams Robyn , Coiera Enrico , Braithwaite Jeffrey , McNeil H Patrick , Hunter David J , Pile Kevin D , Portek Ian , WIlliams Kenneth Mapson , Westbrook Johanna I
Published: May 2024

Introduction

Gout is increasing despite effective therapies to lower serum urate concentrations to 0.36 mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate-lowering therapy (ULT) is poor, with rates of less than 50% 1 year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. We aim to evaluate the effectiveness of use of a personal, self-management, ‘smartphone’ application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT.

Methods and analysis

Setting and design

Primary care. A prospective, cluster randomised (by general practitioner (GP) practices), controlled trial.

Participants

GP practices will be randomised to either intervention or control clusters with their patients allocated to the same cluster.

Intervention

The intervention group will have access to the Healthy.me app tailored for the self-management of gout. The control group patients will have access to the same app modified to remove all functions except the Gout Attack Diary.

Primary and secondary outcomes

The proportion of patients whose serum urate concentrations are less than or equal to 0.36 mmol/L after 6 months. Secondary outcomes will be proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a ≥30% improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed ‘dropout’ rate 20%.

Ethics and dissemination

This study has been approved by the University of New South Wales Human Research Ethics Committee. Study findings will be disseminated in international conferences and peer-reviewed journal.

Trial registration number

ACTRN12616000455460.
Protocol for a feasibility randomised controlled trial of Screening and Enhanced Risk management for Vascular Event-related Decline in Memory (SERVED Memory)
Authors: Myint Phyo Kyaw , Loke Yoon K , Davison William , Mattishent Katharina , Fox George Christopher , Fleetcroft Robert , Turner David , Shepstone Lee , Potter John F
Published: May 2024

Introduction

Stroke is a leading cause of death and disability. The development of dementia after stroke is common. Vascular risk factors (VRF) which contribute to stroke risk can also contribute to cognitive decline, especially in vascular dementia (VaD). There is no established treatment for VaD, therefore strategies for prevention could have major health resource implications. This study was designed to assess whether patients with early cognitive decline after stroke/transient ischaemic attack (TIA) can be easily identified and whether target-driven VRF management can prevent progression to dementia.

Objectives

The primary objective is to establish the feasibility of recruitment and retention of patients with early cognitive decline to a randomised controlled trial of enhanced VRF management. Secondary objectives include: (a) to determine the potential clinical benefit of the intervention; (b) to estimate the sample size for a future definitive multicentre randomised controlled trial; (c) to inform a future economic evaluation; (d) to explore the link between VRF control and the incidence of cognitive impairment on longitudinal follow-up in a UK population after stroke/TIA with current routine management.

Methods

100 patients with cognitive decline poststroke/TIA will be recruited from stroke services at the Norfolk and Norwich University Hospital. After collection of baseline data, they will be randomised to intervention (3 monthly follow-up with enhanced management) or control (treatment as usual by the general practitioner). At 12 months outcomes (repeat cognitive testing, VRF assessment) will be assessed. A further 100 patients without cognitive decline will be recruited to a parallel observational group from the same site. At 12 months they will have repeat cognitive testing.

Ethics and dissemination

Ethical approval has been granted in England. Dissemination is planned via publication in peer-reviewed medical journals and presentation at relevant conferences.

Trial registration number

42688361; Pre-results.
Thermal clothing to reduce heart failure morbidity during winter: a randomised controlled trial
Authors: Barnett Adrian Gerard , Stewart Ian , Beevers Andrea , Fraser John F , Platts David
Published: May 2024

Objective

To examine whether providing thermal clothing improved the health of patients with heart failure during winter.

Design

Parallel group randomised controlled trial.

Setting

Large public hospital in Brisbane during winter 2016.

Participants

91 patients with systolic or diastolic heart failure who were over 50 years old.

Intervention

47 patients were randomised to receive thermal clothes (socks, top and hat) and 44 received usual care. Patients could not be blinded to their randomised group. All patients’ data were available for the primary outcome which was collected blind to randomised group.

Main outcome measures

The primary outcome was the mean number of days in hospital during winter. Secondary outcomes included quality of life and sleep, and blood tests were collected for cardiovascular risk factors. Participants completed clothing diaries in midwinter which were used to estimate their overall clothing insulation using the ‘clo’. Monitors inside the participants’ homes recorded indoor temperatures throughout winter.

Results

The mean number of days in hospital during winter was 4.2 in the usual care group and 3.0 in the thermal clothing group (mean difference –1.2 days, 95% CI –4.8 to 2.5 days). Most participants (85%) in the thermal clothing group reported using the thermals. There was an increase in overall clothing insulation at night in the thermal clothing group (mean difference 0.13 clo, 95% CI 0.03 to 0.23). Most participants in both groups did not wear sufficient clothing (defined as a clo below 1) and regularly experienced indoor temperatures below 18°C during midwinter.

Conclusions

There was no clear statistical improvement in health in the thermal clothing group. Efforts to improve health during winter may need to focus on passive interventions such as home insulation rather than interventions that target behaviour change.

Trial registration number

ACTRN12615001023549; Results.
Protocol for the melatools skin self-monitoring trial: a phase II randomised controlled trial of an intervention for primary care patients at higher risk of melanoma
Authors: Mills Katie , Emery Jon , Lantaff Rebecca , Radford Michael , Pannebakker Merel , Hall Per , Burrows Nigel , Williams Kate , Saunders Catherine L , Murchie Peter , Walter Fiona M
Published: May 2024

Introduction

Melanoma is the fifth most common cancer in the UK. Incidence rates have quadrupled over the last 30 years and continue to rise, especially among younger people. As routine screening of the general population is not currently recommended in the UK, a focus on secondary prevention through early detection and prompt treatment in individuals at increased risk of melanoma could make an important contribution to improve melanoma outcomes. This paper describes the protocol for a phase II, multisite, randomised controlled trial, in the primary care setting, for patients at increased risk of melanoma. A skin self-monitoring (SSM) smartphone ‘App’ was used to improve symptom appraisal and encourage help seeking in primary care, thereby promoting early presentation with skin changes suspicious of melanoma.

Methods and analysis

We aim to recruit 200 participants from general practice waiting rooms in the East of England. Eligible patients are those identified at higher melanoma risk (using a real-time risk assessment tool), without a personal history of melanoma, aged 18 to 75 years. Participants will be invited to a primary care nurse consultation, and randomised to the intervention group (standard written advice on skin cancer detection and sun protection, loading of an SSM ‘App’ onto the participant’s smartphone and instructions on use including self-monitoring reminders) or control group (standard written advice alone). The primary outcomes are consultation rates for changes to a pigmented skin lesion, and the patient interval (time from first noticing a skin change to consultation). Secondary outcomes include patient sun protection behaviours, psychosocial outcomes, and measures of trial feasibility and acceptability.

Ethics and dissemination

NHS ethical approval has been obtained from Cambridgeshire and Hertfordshire research ethics committee (REC reference 16/EE/0248). The findings from the MelaTools SSM Trial will be disseminated widely through peer-reviewed publications and scientific conferences.

Trial registration number

ISRCTN16061621.
Observational study of factors associated with return of home sampling kits for sexually transmitted infections requested online in the UK
Authors: Manavi Kaveh , Hodson James
Published: May 2024

Objectives

To investigate factors associated with the return of home sampling kits for sexually transmitted infections (STIs).

Setting

Online STI testing service offered to the residents of Birmingham and Solihull.

Participants

All patients requesting STI home sampling kits via the Umbrella sexual health service website between 15 July 2016 and 14 December 2016.

Interventions

Associations between data collected at online registration and the rate of return of STI home sampling kits within 30 days of request was assessed.

Results

A total of 5310 kits were requested, of which 3099 (58.4%) were returned to the medical microbiology laboratory. On multivariable analysis, women and men who have sex with men were similarly likely to return their sampling kits (adjusted OR (ORadj) 1.06, 95% CI 0.86 to 1.30), while heterosexual men were significantly less likely to return their sampling kits (ORadj0.63, 95% CI 0.55 to 0.72, p<0.001 vs women). Patients reporting symptoms were also less likely to return kits (ORadj0.77, 95% CI 0.67 to 0.89, p=0.001 vs asymptomatic patients). Kits that were delivered to the patient’s home, rather than to a clinic or pharmacy (p<0.001), and those requested from less economically deprived neighbourhoods (p=0.029) were significantly more likely to be returned.

Conclusion

STI self-sampling testing kits delivered to patients’ homes are most likely to be returned. Heterosexual men and those from more economically deprived areas are the less likely groups to return the kits. Further research on the barriers to return self-sampling STI testing kits of these subgroups of patients is warranted.

Trial registration number

Registered with R&D department at University Hospitals Birmingham; CARMS-13551.
Dementia Population Risk Tool (DemPoRT): study protocol for a predictive algorithm assessing dementia risk in the community
Authors: Fisher Stacey , Hsu Amy , Mojaverian Nassim , Taljaard Monica , Huyer Gregory , Manuel Douglas G , Tanuseputro Peter
Published: May 2024

Introduction

The burden of disease from dementia is a growing global concern as incidence increases dramatically with age, and average life expectancy has been increasing around the world. Planning for an ageing population requires reliable projections of dementia prevalence; however, existing population projections are simple and have poor predictive accuracy. The Dementia Population Risk Tool (DemPoRT) will predict incidence of dementia in the population setting using multivariable modelling techniques and will be used to project dementia prevalence.

Methods and analysis

The derivation cohort will consist of elderly Ontario respondents of the Canadian Community Health Survey (CCHS) (2001, 2003, 2005 and 2007; 18 764 males and 25 288 females). Prespecified predictors include sociodemographic, general health, behavioural, functional and health condition variables. Incident dementia will be identified through individual linkage of survey respondents to population-level administrative healthcare databases (1797 and 3281 events, and 117 795 and 166 573 person-years of follow-up, for males and females, respectively, until 31 March 2014). Using time of first dementia capture as the primary outcome and death as a competing risk, sex-specific proportional hazards regression models will be estimated. The 2008/2009 CCHS survey will be used for validation (approximately 4600 males and 6300 females). Overall calibration and discrimination will be assessed as well as calibration within predefined subgroups of importance to clinicians and policy makers.

Ethics and dissemination

Research ethics approval has been granted by the Ottawa Health Science Network Research Ethics Board. DemPoRT results will be submitted for publication in peer-review journals and presented at scientific meetings. The algorithm will be assessable online for both population and individual uses.

Trial registration number

ClinicalTrials.govNCT03155815, pre-results.
Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial)
Authors: Knaapen Max , van der Lee Johanna H , Bakx Roel , The Sarah-May L , van Heurn Ernst W E , Heij Hugo A , Gorter Ramon R
Published: May 2024

Introduction

Based on epidemiological, immunological and pathology data, the idea that appendicitis is not necessarily a progressive disease is gaining ground. Two types are distinguished: simple and complicated appendicitis. Non-operative treatment (NOT) of children with simple appendicitis has been investigated in several small studies. So far, it is deemed safe. However, its effectiveness and effect on quality of life (QoL) have yet to be established in an adequately powered randomised trial. In this article, we provide the study protocol for the APAC (Antibiotics versus Primary Appendectomy in Children) trial.

Methods and analysis

This multicentre, non-inferiority, randomised controlled trial randomises children aged 7–17 years with imaging-confirmed simple appendicitis between appendectomy and NOT. Patients are recruited in 15 hospitals. The intended sample size, based on the primary outcome, rate of complications and a non-inferiority margin of 5%, is 334 patients.

NOT consists of intravenous antibiotics for 48–72 hours, daily blood tests and ultrasound follow-up. If the patient meets the predefined discharge criteria, antibiotic treatment is continued orally at home. Primary outcome is the rate of complications at 1-year follow-up. An independent adjudication committee will assess all complications and their relation to the allocated treatment. Secondary outcomes include, but are not limited to, delayed appendectomies, QoL, pain and (in)direct costs.

The primary outcome will be analysed both according to the intention-to-treat principle and the per-protocol principle, and is presented with a one-sided 97.5% CI. We will use multiple logistic and linear regression for binary and continuous outcomes, respectively, to adjust for stratification factors.

Ethics and dissemination

The protocol has been approved by the Medical Ethics Review Committee of the Academic Medical Center, Amsterdam. Data monitoring is performed by an independent institute and a Data Safety Monitoring Board has been assigned. Results will be presented in peer-reviewed academic journals and at (international) conferences.

Trial registration number

NCT02848820; NTR5977; Pre-results.
Economic evaluation of an e-mental health intervention for patients with retinal exudative diseases who receive intraocular anti-VEGF injections (E-PsEYE): protocol for a randomised controlled trial
Authors: van der Aa Hilde P A , van Rens Ger H M B , Verbraak Frank D , Bosscha Machteld , Koopmanschap Marc A , Comijs Hannie C , Cuijpers Pim , van Nispen Ruth M A
Published: May 2024

Introduction

Because of the great potential of vascular endothelial growth factor inhibitors (anti-VEGF) for retinal exudative diseases, an increased number of patients receives this treatment. However, during this treatment, patients are subjected to frequent invasive intravitreal injections, and the effects on reversing the process of vision loss are uncertain, which may have negative consequences for patients’ mental health. One in three patients experience at least mild symptoms of depression/anxiety. To support patients in dealing with these symptoms, an e-mental health intervention (called E-PsEYE) has been developed. E-PsEYE is based on cognitive–behavioural therapy (CBT) and contains nine modules. A stepped-care model with three steps will be used to deliver the intervention: (1) providing information and psychoeducation, (2) when symptoms of depression/anxiety persist, guided CBT is offered and supported by social workers from low vision rehabilitation services and (3) when symptoms still persist, patients are referred to their general practitioner.

Methods and analysis

An economic evaluation from a healthcare and societal perspective will be conducted alongside a multicentre randomised controlled trial in two parallel groups to evaluate whether E-PsEYE is cost-effective in comparison with usual care. Participants (n=174) will be 50 years or older, have retinal exudative diseases, receive anti-VEGF treatment and have mild symptoms of depression/anxiety (assessed prior to randomisation). Main outcome measures are: depression (Patient Health Questionnaire-9), anxiety (Hospital Anxiety and Depression Scale-Anxiety) and quality-adjusted life-years (determined with the Health Utility Index-3 and the EuroQol-5 dimensions). Five measurements take place: at baseline and after 3, 6, 9 and 12 months.

Ethics and dissemination

The study has been approved by the Medical Ethics Committee of the VU University Medical Centre Amsterdam. It will provide new and essential information on the cost-effectiveness of an innovative intervention for a vulnerable population. Outcomes will be disseminated through peer-reviewed publications and conference presentations.

Trial registration

http://www.trialregister.nl, identifier: NTR6337.
What are the experiences of seeking, receiving and providing FGM-related healthcare? Perspectives of health professionals and women/girls who have undergone FGM: protocol for a systematic review of qualitative evidence
Authors: Evans Catrin , Tweheyo Ritah , McGarry Julie , Eldridge Jeanette , McCormick Carol , Nkoyo Valentine , Higginbottom Gina Marie Awoko
Published: May 2024

Introduction

Female genital mutilation (FGM) is an issue of global concern. High levels of migration mean that healthcare systems in higher-income western countries are increasingly being challenged to respond to the care needs of affected communities. Research has identified significant challenges in the provision of, and access to, FGM-related healthcare. There is a lack of confidence and competence among health professionals in providing appropriate care, suggesting an urgent need for evidence-based service development in this area. This study will involve two systematic reviews of qualitative evidence to explore the experiences, needs, barriers and facilitators to seeking and providing FGM-related healthcare in high-income (Organisation for Economic Cooperation and Development) countries, from the perspectives of: (1) women and girls who have undergone FGM and (2) health professionals.

Review methods

Twelve databases including MEDLINE, EMBASE, PsycINFO, ASSIA, Web of Science, ERIC, CINAHL, and POPLINE will be searched with no limits on publication year. Relevant grey literature will be identified from digital sources and professional networks.

Two reviewers will independently screen, select and critically appraise the studies. Study quality will be assessed using the Joanna Briggs Institute Qualitative Assessment and Review Instrument appraisal tool. Findings will be extracted into NVivo software. Synthesis will involve inductive thematic analysis, including in-depth reading, line by line coding of the findings, development of descriptive themes and re-coding to higher level analytical themes. Confidence in the review findings will be assessed using the CERQual approach. Findings will be integrated into a comprehensive set of recommendations for research, policy and practice.

Dissemination

The syntheses will be reported as per the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) statement. Two reviews will be published in peer-reviewed journals and an integrated report disseminated at stakeholder engagement events.

PROSPERO registration number

CRD42015030001: 2015 and CRD42015030004: 2015.