bluuebunny/crossref_metadata_2025 huggingface dataset:
194: ROLE OF INFORMATION IN PREVENTION OF UNNECESSARY HEALTH DELIVERY
Authors: Vangari Vishwa Mohan
Published: May 2024

Health is real wealth. Ill-health disables normalcy in one's life, therefore, health delivery proves to be indispensable and invaluable. But at the same time unnecessary health delivery proves to be harmful and costly. In modern times the cost of health delivery is so heavy that people belonging to lower economic strata cannot afford it. When this is the situation, unnecessary health delivery proves to be unethical. It is in view of this Right information at the right time would play a vital role in preventing unnecessary health delivery, that in turn would prevent physical damage caused to the person and also save substantial amount of money. The study aims at exploring how information plays a role in preventing unnecessary health delivery.

The methodology applied to carry out the study was a mix-method of quantitative analysis and qualitative study on a cohort group of 10 patients who had chronic ailments for more than 10 years. The data was collected through a clinical interview with an unstructured schedule consisting of open-ended questions.

The study identified four categories for direct impact of information in control of unnecessary health delivery including cost, hospital readmission diagnostic test prescription, and reduction in drug/medication prescription. In addition, almost all (90%) respondents fully agreed to the vital role of information in preventing unnecessary health delivery. All the respondents (100%) emphasis that the information should flow through authentic sources. Most of the respondents state that professional ethics and integrity occupy primary place in avoiding unnecessary health delivery.
25: ASSOCIATION OF SERUM GAMMA- INTERFERON AND IL-10 CONCENTRATIONS WITH INSULIN RESISTANCE IN MAJOR THALASSEMIA PATIENTS
Authors: Jahromi Abdolreza Sotoodeh , Rahmanian Zhila
Published: May 2024

Background and aims:

Thalassemia is one of the most prevalent hematologic disorders worldwide. Thalassemia is the most common inherited anemia and genetic disease. Diabetes mellitus and insulin resistance is one of the major endocrine problems in major thalassemia patients. This study was done to evaluate the association of serum γ- interferon and IL-10 concentrations with insulin resistance in splenectomized and non-splenectomized major thalassemia patients.

Methods:

193 thalassemia patients with rang of years old participated in this study. IFN-γ and IL-10 levels were measured using ELISA method. Insulin resistance was measured using HOMA-IR method. Data was analyzed with SPSS software by Pair T test.

Results:

the mean age of splenectomized patients in this study was 8.86±7.03 and non- splenectomized patients 7.88±2.39 years. There were significant and inverse associations between serum IL-10 levels and insulin resistance was found in non-splenectomized major thalassemia patients (P=0.002). There were not a significant association between serum IL-10 levels and insulin resistance in splenectomized major thalassemia patients (P=0.079). There were not a significant association between serum γ- interferon levels and insulin resistance in splenectomized major thalassemia patients (P=0.778). There were not significant associations between serum γ- interferon levels and insulin resistance in non- splenectomized major thalassemia patients (P=0.435).

Conclusion:

In this study, interferon-gamma as an inflammatory cytokine and interlukin-10 as an anti-inflammatory cytokines was studied. Overall these results suggest that interleukin-10 is associated with insulin resistance in non-splenectomized major thalassemia patients and as an anti-inflammatory cytokine may play an important role in sustaining insulin resistance in non-splenectomized major thalassemia patients. With increase in serum IL-10 levels there is a decline in insulin resistance. This data provide new insights into the mechanisms of insulin resistance and support the use of other cytokines with insuln resistance in major thalassemia patients.
28: CAN PHTHALATES DISRUPT OOCYTE MEIOTIC MATURATION IN MOUSE MODEL?
Authors: Absalan Forouzan
Published: May 2024

Background and aims:

Phthalates, which are commonly used to render plastics into soft and flexible materials, have also determined as developmental and reproductive toxicants in human and animals. The purpose of this study was to evaluate the effect of mono-(2-ethylhexyl) phthalate (MEHP) and di-(2-ethylhexyl) phthalate (DEHP) oral administration on maturation of mouse oocytes, apoptosis and gene transcription levels.

Methods:

Immature oocytes recovered from NMRI mouse strain (6–8 weeks) were divided into seven different experimental and control groups. Control group oocytes were retrieved from mice that received only normal saline. Experimental groups I, II or III oocytes were retrieved from mice treated with 50, 100 or 200 µl DEHP (2.56 µM) solution, respectively. Experimental groups IV, V or VI oocytes were retrieved from mouse exposed to 50, 100 or 200 µl MEHP (2.56 µM) solution, respectively. Fertilization and embryonic development were carried out in OMM and T6 medium. Apoptosis was assessed by annexin V-FITC/Dead Cell Apoptosis Kit with PI staining. In addition, the mRNA levels ofPou5f1,Ccna1andAsah1were examined in oocytes.

Results:

The proportion of oocytes that progressed up to metaphase II (MII) and 2-cells embryo formation stage was significantly decreased by exposure to MEHP or DEHP, in a dose related pattern. Annexin V and PI positive oocytes showed greater quantity in treated mice than control. Quantitative RT-PCR revealed that expression levels ofPou5f1,Asah1andCcna1were significantly lower in treated mouse oocytes than control.

Conclusion:

These results indicate that oral administration of MEHP and DEHP could negatively affect mouse oocyte meiotic maturation and developmentin vivo, suggesting that phthalates could be risk factors for mammalians' reproductive health. Phthalate-induced changes inPou5f1,Asah1andCcna1transcription level explain in part the reduced developmental ability of mouse-treated oocytes.
36: COMPARISON OF SIDE EFFECTS IN TWO METHODS OF ENDOTRACHEAL SUCTIONING (OPEN AND CLOSED) IN PREMATURE INFANTS UNDER MECHANICAL VENTILATION
Authors: Janani Raheleh , Jannatdoost Abdollah , Seyedrasuli Alehe , Valizadeh Leila , Sarbakhsh Parvin
Published: May 2024

Background and aims:

Endo tracheal suctioning is a common neonatal intensive care procedure that is performed to clear trachea bronchial airways of secretions and maintain patency of the endotracheal tube in intubated infants, which may lead to complications. Two systems are available to perform ES: open suction system and closed suction system. Since bacterial airway colonization, nosocomial pneumonia, and septicemia are important issues in neonatal care, recent study aims to compare side effects in two methods of endotracheal suctioning (open and closed) in premature infants under mechanical ventilation.

Methods:

In current clinical trial study, 90 preterm infants of (27–34 weeks of GA) hospitalized in NICUs of Alzahra and Taleghani Teaching hospitals, (2014), elected and randomly assigned to two groups. One group was suctioned by open suctioning method and the other by closed suctioning method. However frequency of suctioning and side effects as pulmonary hemorrhage, IVH, pneumothorax, pneumonia and septicemia until extubation and duration of hospitalization were investigated and compared. Data analysis was performed using SPSS (ver. 21) and descriptive and analytic statistical methods such as x2 and independent T test analysis.

Results:

Overall, there was no significant statistical difference on frequency of suctioning and side effects as pulmonary hemorrhage, IVH, pneumothorax, pneumonia and septicemia until extubation and duration of hospitalization. But all side effects and mortality rate were higher in open suction.

Conclusion:

Evidence indicates that, there was no significant statistical difference on frequency of suctioning, side effects and duration of hospitalization. Considering clinical significance with regard to Evidenc-Based Clinical Decision Making, it is recommended that a comprehensive study over a greater population of premature infants should be carried out.
39: CONNECTING THE DOTS BETWEEN BEST EVIDENCES REGARDING SOCIAL DETERMINANTS OF PATIENTS OUTCOMES AND HEALTH CARE POLICY MAKING
Authors: Pezeshki Mohammad Zakaria
Published: May 2024

Four out of 5 American primary care physicians do believe that addressing social needs of their patients are as important as addressing medical conditions of their patients. There are several researches showing that addressing social determinants of health improve the clinical outcome of the patients considerably. In this review we discuss how physician's evidence based advocacy and negotiation with policy makers may create opportunity for addressing social needs of the patients. The recent research initiative of family physicians in New Mexico, USA that resulted in state level policy making for addressing social needs of the patient will be discussed.
5: A SURVEY ON INFORMATION DERIVATION TECHNIQUES OF POST-GRADUATE STUDENT OF TABRIZ UNIVERSITY OF MEDICAL SCIENCE IN 2015
Authors: Sohrabi Zahra-Sadat , Gavgani Vahideh Zarea
Published: May 2024

Background and aims:

The purpose of this study was to identify the information derivation techniques of medical and allied health sciences' postgraduate students.

Methods:

The study was a cross sectional descriptive survey. The data was collected from Tabriz University of Medical Sciences' student using a structured questionnaire. Data was analyzed using descriptive statistics and T-test through SPSS 16.

Results:

Total of 300 questionnaire were collected that 178(59.3%) of them were female students and 122 (40.7%) male. Out of 300, number of 160 (53.3%) were studding in M.Sc. level and 140 (46.7%) were doctoral students. Findings of study showed that the most significant motivation of students for searching information was continuing education in the higher levels, finding answer for the course assignments and projects. Academic publishing were the other considerable reasons for information search and retrieval. Searching information via general search engines like Google with (70.7%) and book with (50.3%) were the most used formal information resources by students. The most considerable limitation for accessing information was numerated as low speed Internet/networks, and internet disconnection (59.7%), subscription discontinuing with some of databases (47%).

Conclusion:

The study did not find differences between male and female students information seeking skills. The students' attitudes towards using databases and search tools were different among M.Sc. and Doctoral students. There were no statistically significant differences between the students' educational level and their aim for information searching as well as the educational level and the limitations they face in searching information. The biggest complaint of students was the speed of internet connection in all level, and access to core databases. Therefore it is suggested to promote the internet connection speed and access at least in university campus.
61: EVIDENCE BASE NURSING PRACTICE: A CROSS SECTIONAL STUDY IN SOUTH OF IRAN
Authors: Khammarnia Mohammad , Mohammadi Mahsa Haj , Amani Zahra , Rezaeian Shahab , Setoodehzadeh Fatemeh
Published: May 2024

Background and aims:

This study aimed to determine the barriers to implementation of EBP among nurses.

Methods:

This cross-sectional study was conducted in Zahedan City, South East of Iran, in 2014. The questionnaire of barriers to implementation of EBP consists of 27 statements which were distributed among 280 nurses.

Results:

More than half of the participants agreed that 56% and 57% of barriers to implementation of evidence based practice are related to organizational and individual aspects, respectively. Participants identified barriers at organizational level included the lack of human resources (78.3%), lack of internet access at work (72.2%), and heavy workload (70.0%). Barrier at individual level included lack of time to read literature (83.7%), lack of ability to work with computer (68.8%), and insufficient proficiency in English language (62.0%). Age, educational level, job experience, and employment status were associated with organizational barriers to implementation of EBP. At the individual level only education was associated with barriers to implementation of EBP.

Conclusion:

Barriers to implementation of EBP occur at both individual and organizational levels. The indicator of quality in nursing practice is EBP. Hence, familiarity with EBP is recommended for Iranian nurses. In addition, knowledge of barriers will help health care system and policy makers to provide a culture of EBP.
63: EVIDENCE BASED PRACTICAL GUIDELINE FOR THE MANAGEMENT OF MAJOR HEMORRHAGE IN CHILDREN AND TEENAGERS
Authors: Shahriari Mahdi
Published: May 2024

Background and aims:

Management of major hemorrhage in any setting requires a multidisciplinary approach. The aim of this guideline is to provide recommendations for the hematological management of major hemorrhage in any clinical situation, with practical guidance for Clinical Hematologists and laboratory staff on the content and delivery of major bleeding protocols, including the use of blood components and transfusion alternatives. These updated guidelines are based on new studies, which have provoked reassessment of the principles of managing major hemorrhage in all clinical situations, and which mandate much closer working between hospital blood banks and emergency departments to provide timely transfusion support for patients with major bleeding.

Methods:

The writing group was Pediatric hematologists-Oncologists who were transfusion and hemostasis experts, and consultation with the Trauma, Anesthesiologists, Obstetric-Gynecologists, Hematopathologists and critical care was made. Relevant systematic reviews were identified by searching PubMed and Embase using the term “bleeding” and “hemorrhage” combined with “management”, “trials”, “children” and “teenagers”. The search covered articles published up until April 2016. Only human studies were included and articles not written in English were excluded. The quality of evidence was judged by predefined Grades of Recommendation, Assessment, Development and Evaluation (GRADE) criteria.

Results:

Definition of major hemorrhage: Standard definitions are not particularly helpful because they are retrospective. Our arbitrary definition of major hemorrhage is bleeding which leads to a heart rate more than 110 beats/ min and/or systolic blood pressure less than 90 mmHg for teenagers and less than third percentile for age in children. Early recognition of significant blood loss, ideally before major increments in pulse rate and falls in blood pressure, will allow prompt action to pre-empt shock.

Conclusion:

Medical, nursing and midwifery staff involved in frontline care must be trained to recognize major blood loss early, know when to activate the local major hemorrhage protocol and take prompt and appropriate action (1D). Annual workshops for continuous medical education are highly suggested.
99: PREVALENCE OF METHYLPHENIDATE (RITALIN) MISUSE AMONG STUDENTS OF IRAN: A SYSTEMATIC REVIEW
Authors: Amirzade-Iranaq Mohammad Hossein , Masoumi Seyyed Mohammad Reza
Published: May 2024

Background and aims:

Methylphenidate (Ritalin) is a medication prescribed for hyperactive children known as ADHS disorder. But the rate of misuse of this drug among students is critical. The purpose of this study was to evaluate the prevalence of misuse of methylphenidate among students of Iran.

Methods:

Electronic search performed based on PubMed, Scopus, PsycINFO and Web of Science for relevant studies and also hand-searching for recognizing non-indexed sources. English and Persian languages restriction included and only cross sectional studies entered to this study.

Data extraction: 28 articles found through databases searching and also 3 Additional records identified by hand-searching. After excluding of duplicates and studies not meeting inclusion criteria like knowledge attitude studies, at last 7 Full-text articles assessed for eligibility. Quality assessment of this study was executed by using the Critical Appraisal Skills Programme (CASP). Because of high heterogeneity among this article we decided to ignore quantitative analysis and meta-analysis.

Results:

The Prevalence of Methylphenidate (Ritalin) in studies were so different (5% to 43%) among students of Iran, But also the prevalence was significantly higher in men in all of studies. almost 30% of students use this drug at least one time during their life. The most time they used related to exams period and the most their reason was that it help them to more concentrate and enhance the cognition.

Conclusion:

This study shows us the prevalence of Methylphenidate (Ritalin) misuse among students of Iran are so high and because of its side effects it could be an alarm for youth people in Iran. Increase the awareness about the use of methylphenidate are needed critically.
Protocol for a cohort study of adolescent mental health service users with a nested cluster randomised controlled trial to assess the clinical and cost-effectiveness of managed transition in improving transitions from child to adult mental health services (the MILESTONE study)
Authors: Singh Swaran P , Tuomainen Helena , Girolamo Giovanni de , Maras Athanasios , Santosh Paramala , McNicholas Fiona , Schulze Ulrike , Purper-Ouakil Diane , Tremmery Sabine , Franić Tomislav , Madan Jason , Paul Moli , Verhulst Frank C , Dieleman Gwen C , Warwick Jane , Wolke Dieter , Street Cathy , Daffern Claire , Tah Priya , Griffin James , Canaway Alastair , Signorini Giulia , Gerritsen Suzanne , Adams Laura , O’Hara Lesley , Aslan Sonja , Russet Frédérick , Davidović Nikolina , Tuffrey Amanda , Wilson Anna , Gatherer Charlotte , Walker Leanne
Published: May 2024

Introduction

Disruption of care during transition from child and adolescent mental health services (CAMHS) to adult mental health services may adversely affect the health and well-being of service users. The MILESTONE (Managing the Link and Strengthening Transition from Child to Adult Mental Healthcare) study evaluates the longitudinal course and outcomes of adolescents approaching the transition boundary (TB) of their CAMHS and determines the effectiveness of the model of managed transition in improving outcomes, compared with usual care.

Methods and analysis

This is a cohort study with a nested cluster randomised controlled trial. Recruited CAMHS have been randomised to provide either (1) managed transition using the Transition Readiness and Appropriateness Measure score summary as a decision aid, or (2) usual care for young people reaching the TB. Participants are young people within 1 year of reaching the TB of their CAMHS in eight European countries; one parent/carer and a CAMHS clinician for each recruited young person; and adult mental health clinician or other community-based care provider, if young person transitions. The primary outcome is Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) measuring health and social functioning at 15 months postintervention. The secondary outcomes include mental health, quality of life, transition experience and healthcare usage assessed at 9, 15 and 24 months postintervention. With a mean cluster size of 21, a total of 840 participants randomised in a 1:2 intervention to control are required, providing 89% power to detect a difference in HoNOSCA score of 0.30 SD. The addition of 210 recruits for the cohort study ensures sufficient power for studying predictors, resulting in 1050 participants and an approximate 1:3 randomisation.

Ethics and dissemination

The study protocol was approved by the UK National Research Ethics Service (15/WM/0052) and equivalent ethics boards in participating countries. Results will be reported at conferences, in peer-reviewed publications and to all relevant stakeholder groups.

Trial registration number

ISRCTN83240263;NCT03013595(pre-results).
The CLIMB (Complex Lipids In Mothers and Babies) study: protocol for a multicentre, three-group, parallel randomised controlled trial to investigate the effect of supplementation of complex lipids in pregnancy, on maternal ganglioside status and subsequent cognitive outcomes in the offspring
Authors: Huang Shuai , Mo Ting-Ting , Norris Tom , Sun Si , Zhang Ting , Han Ting-Li , Rowan Angela , Xia Yin-Yin , Zhang Hua , Qi Hong-Bo , Baker Philip N
Published: May 2024

Introduction

Complex lipids are important constituents of the central nervous system. Studies have shown that supplementation with complex milk lipids (CML) in pregnancy may increase the level of fetal gangliosides (GA), with the potential to improve cognitive outcomes.

Methods and analysis

We aim to recruit approximately 1500 pregnant women in the first trimester (11–14 weeks) and randomise them into one of the three treatment groups: standard maternal milk formulation, CML-enhanced maternal milk formulation or no maternal milk intervention with standard pregnancy advice (ie, the standard care). Maternal lifestyle and demographic data will be collected throughout the pregnancy, as well as biological samples (eg, blood, hair, urine, buccal smear, cord blood, cord and placenta samples). Data from standard obstetric care recorded in hospital maternity notes (eg, ultrasound reports, results of oral glucose tolerance test and pregnancy outcome data) will also be extracted. Postnatal follow-up will be at 6 weeks and 12 months of age, at which point infant cognitive development will be assessed (Bayley Scales of Infant Development I).

Ethics and dissemination

This project was approved by the Ethics Committee of Chongqing Medical University. Dissemination of findings will take the form of publications in peer-reviewed journals and presentations at national and international conferences.

Trial registration number

ChiCTR-IOR-16007700; Pre-results.
The Efficacy of the proprioceptive neuromuscular facilitation (PNF) approach in stroke rehabilitation to improve basic activities of daily living and quality of life: a systematic review and meta-analysis protocol
Authors: Guiu-Tula Francesc Xavier , Cabanas-Valdés Rosa , Sitjà-Rabert Mercè , Urrútia Gerard , Gómara-Toldrà Natàlia
Published: May 2024

Introduction

Proprioceptive neuromuscular facilitation (PNF) is a widely used rehabilitation concept, although its efficacy has not yet been demonstrated in stroke survivors. The aim of this systematic review is to identify, assess and synthesise the potential benefits of using PNF to improve the activities of daily living (ADL) and quality of life (QoL) of individuals with stroke.

Methods and analysis

A systematic electronic search will be conducted in MEDLINE, Embase, CENTRAL and PEDro. We will include randomised or quasi-randomised controlled trials of PNF interventions conducted in stroke survivors up to April 2017. Two review authors will independently select relevant studies and will extract data using the Cochrane handbook for systematic reviews of interventions approach and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The methodological quality will be assessed by using the PEDro scale. Finally, with the permitted numeric data, we will carry out a meta-analysis.

Ethics and dissemination

Ethical considerations will not be required. Results will be disseminated in a peer-review journal. This systematic review aims to examine the effects of PNF (neurophysiological approach) in order to clarify its efficacy in improving ADL and QoL in the rehabilitation process of stroke survivors.

PROSPERO registration number

CRD42016039135.
Effects of a multicomponent workplace intervention programme with environmental changes on physical activity among Japanese white collar employees: a protocol for a cluster randomised controlled trial
Authors: Watanabe Kazuhiro , Kawakami Norito
Published: May 2024

Introduction

Physical activity is one of the most important health behaviours as a determinant of physical and mental health. Although intervention strategies for promoting physical activity among workers are needed, evidence for the effectiveness of multilevel workplace interventions with environmental changes on the promotion of physical activity are still limited due to lack of cluster randomised controlled trials (RCTs). The aim of this study is to investigate effects of a 3-month workplace intervention programme with environmental changes on the improvement in physical activity among Japanese white collar employees.

Methods and analysis

This study will be a two-arm and parallel-group cluster (worksite) RCT. Japanese worksites and employees who are employed by the worksites will be recruited through health insurance associations and chambers of commerce. Worksites that meet the inclusion criteria will be randomly allocated to intervention or control groups. The intervention worksites will be offered the original intervention programme that consists of 13 contents with environmental changes. The control worksites will be able to get three times feedback of the assessment of the amount of physical activity and basic occupational health service in each worksite. The primary outcome will be the total amount of physical activity measured by the Global Physical Activity Questionnaire at baseline, 3 months and 6 months. Multilevel latent growth modelling will be conducted to examine the effectiveness of the intervention programme.

Ethics and dissemination

This study was ethically approved by the research ethics committee of the Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Japan (No. 11230). Results will be submitted and published in a scientific peer-reviewed journal.

Trial registration number

UMIN000024069; Pre-results.
Viability testing and transplantation of marginal livers (VITTAL) using normothermic machine perfusion: study protocol for an open-label, non-randomised, prospective, single-arm trial
Authors: Laing Richard W , Mergental Hynek , Yap Christina , Kirkham Amanda , Whilku Manpreet , Barton Darren , Curbishley Stuart , Boteon Yuri L , Neil Desley A , Hübscher Stefan G , Perera M Thamara P R , Muiesan Paolo , Isaac John , Roberts Keith J , Cilliers Hentie , Afford Simon C , Mirza Darius F
Published: May 2024

Introduction

The use of marginal or extended criteria donor livers is increasing. These organs carry a greater risk of initial dysfunction and early failure, as well as inferior long-term outcomes. As such, many are rejected due to a perceived risk of use and use varies widely between centres. Ex situ normothermic machine perfusion of the liver (NMP-L) may enable the safe transplantation of organs that meet defined objective criteria denoting their high-risk status and are currently being declined for use by all the UK transplant centres.

Methods and analysis

Viability testing and transplantation of marginal livers is an open-label, non-randomised, prospective, single-arm trial designed to determine whether currently unused donor livers can be salvaged and safely transplanted with equivalent outcomes in terms of patient survival. The procured rejected livers must meet predefined criteria that objectively denote their marginal condition. The liver is subjected to NMP-L following a period of static cold storage. Organs metabolising lactate to ≤2.5 mmol/L within 4 hours of the perfusion commencing in combination with two or more of the following parameters—bile production, metabolism of glucose, a hepatic arterial flow rate ≥150 mL/min and a portal venous flow rate ≥500 mL/min, a pH ≥7.30 and/or maintain a homogeneous perfusion—will be considered viable and transplanted into a suitable consented recipient. The coprimary outcome measures are the success rate of NMP-L to produce a transplantable organ and 90-day patient post-transplant survival.

Ethics and dissemination

The protocol was approved by the National Research Ethics Service (London—Dulwich Research Ethics Committee, 16/LO/1056), the Medicines and Healthcare Products Regulatory Agency and is endorsed by the National Health Service Blood and Transplant Research, Innovation and Novel Technologies Advisory Group. The findings of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

NCT02740608; Pre-results.
Minimally invasive surgery versus open surgery in the treatment of lumbar spondylolisthesis: study protocol of a multicentre, randomised controlled trial (MISOS trial)
Authors: Arts Mark P , Wolfs Jasper FC , Kuijlen Jos MA , de Ruiter Godard CW
Published: May 2024

Introduction

Patients with symptomatic spondylolisthesis are frequently treated with nerve root decompression, in addition to pedicle screw fixation and interbody fusion. Minimally invasive approaches are gaining attention in recent years, although there is no clear evidence supporting the proclamation of minimally invasive spine surgery (MISS) being better than open surgery. We present the design of the MISOS (Minimal Invasive Surgery versus Open Surgery) trial on the effectiveness of MISS versus open surgery in patients with degenerative or spondylolytic spondylolisthesis.

Methods and analysis

All patients (age 18–75 years) with neurogenic claudication or radicular leg pain based on low-grade degenerative or spondylolytic spondylolisthesis with persistent complaints for at least 3 months are eligible. Patients will be randomised into mini-open decompression with bilateral interbody fusion with percutaneous pedicle screw fixation (MISS), or conventional surgery with decompression and instrumented fusion with pedicle screws and bilateral interbody fusion (open). The primary outcome measure is Visual Analogue Scale of self-reported low back pain. Secondary outcome measures include improvement of leg pain, Oswestry Disability Index, patients’ perceived recovery, quality of life, resumption of work, complications, blood loss, length of hospital stay, incidence of reoperations and documentation of fusion. This study is designed as a multicentre, randomised controlled trial in which two surgical techniques are compared in a parallel group design. Based on a 20 mm difference of low back pain score at 6 weeks (power of 90%, assuming 8% loss to follow-up), a total of 184 patients will be needed. All analyses will be performed according to the intention-to-treat principle.

Ethics and dissemination

The study has been approved by the Medical Ethical Review Board Southwest Holland in August 2014 (registration number NL 49044.098.14) and subsequently approved by the board of all participating hospitals. Dissemination will include peer-reviewed publications and presentations at national and international conferences.

Trial registration number

NTR 4532, pre-results.
Prevalence of pregnancy-related pelvic girdle pain and associated factors in Australia: a cross-sectional study protocol
Authors: Ceprnja Dragana , Chipchase Lucinda , Gupta Amitabh
Published: May 2024

Introduction

Pregnancy-related pelvic girdle pain (PPGP) is a common musculoskeletal disorder. Women with PPGP report difficulty performing everyday functional activities, such as standing and walking. However, the magnitude of the problem remains unknown in Australia. It is important to determine how many women are affected by this condition and the factors associated with PPGP as this will direct healthcare services to being able to better manage women during pregnancy. Thus, this study aims to determine the prevalence of PPGP and associated factors in a Western Sydney population.

Methods and analysis

This study is a cross-sectional study to be conducted at a single hospital in Australia. Participants will be over 18 years of age, between 14 and 38 weeks gestation and recruited randomly from all pregnant women attending antenatal care. Participants will have anthropomorphic measures recorded, such as height and body weight, and be asked to complete questionnaires about their current pregnancy, sociodemographic information, ethnoculture, occupational factors and participation in functional activities. The classification of PPGP will be made as per the published guidelines and will include a physical examination.

Ethics and dissemination

Ethical approval has been granted by the Human Research Ethics Committees of Westmead Hospital, Sydney, and Western Sydney University, Sydney. Dissemination of results will be via journal articles and conference presentations.

Trial registration number

ACTRN12617000904370.
Neoadjuvant S-1 with concurrent radiotherapy followed by surgery for borderline resectable pancreatic cancer: study protocol for an open-label, multicentre, prospective phase II trial (JASPAC05)
Authors: Takahashi Shinichiro , Ohno Izumi , Ikeda Masafumi , Kobayashi Tatsushi , Akimoto Tetsuo , Kojima Motohiro , Konishi Masaru , Uesaka Katsuhiko
Published: May 2024

Introduction

Borderline resectable pancreatic cancer (BRPC) can involve the portal vein, superior mesenteric vein, superior mesenteric artery, coeliac axis or hepatic artery, and has a high probability of positive surgical margins and poor prognosis after resection. Neoadjuvant chemoradiation is expected to provide substantial local control and prolong survival in patients with BRPC.

Methods and analysis

This open-label, multicentre, prospective phase II trial will assess S-1 with concurrent radiotherapy as preoperative treatment for BRPC. Participants will receive S-1 (40 mg/m2twice daily) and concurrent radiotherapy (50.4 Gy in 28 fractions), with restaging and surgery after 3–8 weeks. Recruitment will be for a 36-month period with a minimum 24-month follow-up. The primary endpoint is the R0 resection rate for BRPC confirmed with central review. The secondary endpoints are overall survival, disease-free survival, response rate to neoadjuvant chemoradiation, pathological response rate, 2-year survival rate, surgical morbidity rate and acute and late toxicity rates. Objectives include quantifying the number of participants per year to evaluate whether randomised trials can be performed for this rare tumour.

Ethics and dissemination

This trial has been approved by the National Cancer Center Institutional Review Board. Written informed consent will be obtained from all participants. Serious adverse events will be reported to the safety desk of the trial, the Data and Safety Monitoring Board and trial sites. Trial results will be submitted for peer-reviewed publication.

Trial registration number

Pre-results, UMIN000009172.
Stepped care approach for medial tibiofemoral osteoarthritis (STrEAMline): protocol for a randomised controlled trial
Authors: Robbins Sarah Rubia , Melo Luciano Ricardo S , Urban Hema , Deveza Leticia A , Asher Rebecca , Johnson Victoria L , Hunter David J
Published: May 2024

Introduction

Current guidelines recommend tailored interventions to optimise knee osteoarthritis (OA) management. However, models of care still have a ‘one size fits all’ approach, which is suboptimal as it ignores patient heterogeneity. This study aims to compare a stepped care strategy with standard care for overweight and obese persons with medial tibiofemoral OA.

Methods and analysis

Participants will be randomised into two groups (85 each). The intervention will receive a diet and exercise programme for 18 weeks in the first step of the study. Disease remission will then be assessed using the Patient Acceptable Symptom State (PASS). PASS is defined as the highest level of symptom beyond which patients consider themselves well and takes into account pain intensity, patient’s global assessment of disease activity and degree of functional impairment. In the second step, participants in remission will continue with diet and exercise. If remission is not achieved, participants will be assigned in a hierarchical order to cognitive behavioural therapy, knee brace or muscle strengthening for 12 weeks. The intervention will be decided based on their clinical presentation for symptoms of depression and varus malalignment. Participants without depression or varus malalignment will undertake a muscle strengthening programme. The control group will receive educational material related to OA management. Main inclusion criteria are age ≥50 years, radiographic medial tibiofemoral OA, body mass index (BMI) ≥28 kg/m2, knee pain ≥40 (Visual Analogue Scale, 0–100), PASS (0–100) >32 for pain and global assessment, and 31 for functional impairment. Outcomes will be measured at 20-week and 32-week visits. The primary outcome is disease remission at 32 weeks. Other outcomes include functional mobility; patient-reported outcomes; BMI; waist-hip ratio; quadriceps strength; symptoms of depression, anxiety and stress; and knee range of motion. The analysis will be performed according to the intention-to-treat principle.

Ethics and dissemination

The local ethics committee approved this protocol (HREC/14/HAWKE/381). Dissemination will occur through presentations at international conferences and publication in peer-reviewed journals.

Trial registration number

ACTRN12615000227594.
Comparison of three diagnostic strategies for suspicion of pulmonary embolism: planar ventilation-perfusion scan (V/Q), CT pulmonary angiography (CTPA) and single photon emission CT ventilation-perfusion scan (SPECT V/Q): a protocol of a randomised controlled trial
Authors: Le Pennec Romain , Le Roux Pierre-Yves , Robin Philippe , Couturaud Francis , Righini Marc , Le Gal Grégoire , Salaun Pierre-Yves
Published: May 2024

Introduction

Pulmonary embolism (PE) is a challenge to diagnose and when missed, exposes patients to potentially fatal recurrent events. Beyond CT pulmonary angiography (CTPA) and planar ventilation/perfusion (V/Q) scan, single photon emission CT (SPECT) V/Q emerged a new diagnostic modality of scintigraphic acquisition that has been reported to improve diagnostic performances. To date, no management outcome study or randomised trial evaluated an algorithm based on SPECT V/Q for PE diagnosis. We present the design of a randomised multicentre, international management study comparing SPECT V/Q with validated strategies.

Material and methods

We will include a total of 3672 patients with suspected PE requiring chest imaging, randomised into three different groups, each using a different diagnostic strategy based on SPECT V/Q, CTPA and planar V/Q scan. Randomisation will be unbalanced (2:1:1), with twice as many patients in SPECT V/Q arm (n=1836) as in CTPA and planar V/Q arms (n=918 in each). Our primary objective will be to determine whether a diagnostic strategy based on SPECT V/Q is non-inferior to previously validated strategies in terms of diagnostic exclusion safety as assessed by the 3-month risk of thromboembolism in patients with a negative diagnostic workup. Secondary outcomes will be the proportion of patients diagnosed with PE in each arm, patients requiring additional tests, the incidence of major and clinically relevant non-major bleeding and the incidence and cause of death in each arm.

Ethics and dissemination

This trial is funded by a grant from Brest University Hospital and by INVENT. The study protocol was approved by Biomedical Research Ethics Committee. The investigator or delegate will obtain signed informed consent from all patients prior to inclusion in the trial. Our results will inform future clinical practice guidelines and solve the current discrepancy between nuclear medicine guidelines and clinical scientific society guidelines.

Trial registration number

NCT02983760
Low back pain management in primary healthcare: findings from a scoping review on models of care
Authors: Duarte Susana Tinoco , Moniz Alexandre , Costa Daniela , Donato Helena , Heleno Bruno , Aguiar Pedro , Cruz Eduardo B
Published: May 2024

Introduction

Models of care (MoCs) describe evidence-informed healthcare that should be delivered to patients. Several MoCs have been implemented for low back pain (LBP) to reduce evidence-to-practice gaps and increase the effectiveness and sustainability of healthcare services.

Objective

To synthesise research evidence regarding core characteristics and key common elements of MoCs implemented in primary healthcare for the management of LBP.

Design

Scoping review.

Data sources

Searches on MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials, PEDro, Scopus, Web of Science and grey literature databases were conducted.

Eligibility criteria

Eligible records included MoCs implemented for adult LBP patients in primary healthcare settings.

Data extraction and synthesis

Data extraction was carried out independently by two researchers and included a summary of the studies, the identification of the MoCs and respective key elements, concerning levels of care, settings, health professionals involved, type of care delivered and core components of the interventions. Findings were investigated through a descriptive qualitative content analysis using a deductive approach.

Results

29 studies reporting 11 MoCs were included. All MoCs were implemented in high-income countries and had clear objectives. Ten MoCs included a stratified care approach. The assessment of LBP patients typically occurred in primary healthcare while care delivery usually took place in community-based settings or outpatient clinics. Care provided by general practitioners and physiotherapists was reported in all MoCs. Education (n=10) and exercise (n=9) were the most common health interventions. However, intervention content, follow-ups and discharge criteria were not fully reported.

Conclusions

This study examines the features of MoCs for LBP, highlighting that research is in its early stages and stressing the need for better reporting to fill gaps in care delivery and implementation. This knowledge is crucial for researchers, clinicians and decision-makers in assessing the applicability and transferability of MoCs to primary healthcare settings.
Coproduction of accessible digital mental health supports in partnership with young people from marginalised backgrounds: a scoping review protocol
Authors: Kealy Carmen , Potts Courtney , Mulvenna Maurice D , Donohoe Gary , O'Neill Siobhan , Barry Margaret M
Published: May 2024

Introduction

Despite the evidence supporting the value of digital supports for enhancing youth mental health services, there is a lack of guidance on how best to engage with young people in coproduction processes during the design and evaluation of these technologies. User input is crucial in digital mental health, especially for disadvantaged, vulnerable and marginalised young people as they are often excluded from coproduction. A scoping review of international literature written in English will explore the coproduction processes with marginalised young people in digital mental health supports, from mental health promotion to targeted interventions. The review is guided by the research question: what are the most appropriate coproduction processes for engaging young people, especially marginalised young people, in the different stages of designing and evaluating digital mental health supports? The review aims to map and summarise the evidence, inform the overall research project and address the knowledge gaps.

Methods and analysis

The scoping review uses Arksey and O’Malley’s framework and the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols Extension for Scoping Reviews. From 22–24 October 2023, PubMed, Scopus, EBSCO, ASSIA, Web of Science, Ovid MEDLINE, Cochrane database, Embase, Google Scholar, ProQuest, OAIster and BASE will be systematically searched. Papers from 2021 onwards with a range of study designs and evidence that illustrate engagement with marginalised young people (aged 16–25) in the design, implementation and evaluation of digital technologies for young people’s mental health will be considered for inclusion. At least two reviewers will screen full texts and chart data. The results of this review will be summarised quantitatively through numerical counts of included literature and qualitatively through a narrative synthesis.

Ethics and dissemination

Ethical approval is not required. Results will be disseminated through publications in peer-reviewed journals.

Trial registration number

This scoping review protocol has been registered with the Open Science Framework (https://osf.io/9xhgv).
Risk-adjusted trend in national inpatient fall rates observed from 2011 to 2019 in acute care hospitals in Switzerland: a repeated multicentre cross-sectional study
Authors: Bernet Niklaus S , Everink Irma H J , Hahn Sabine , Müller Marianne , Schols Jos M G A
Published: May 2024

Objectives

This study aimed to investigate whether a significant trend regarding inpatient falls in Swiss acute care hospitals between 2011 and 2019 could be confirmed on a national level, and whether the trend persists after risk adjustment for patient-related fall risk factors.

Design

A secondary data analysis was conducted based on annual multicentre cross-sectional studies carried out between 2011 and 2019.

Setting

All Swiss acute care hospitals were obliged to participate in the surveys. Except for emergency departments, outpatient wards and recovery rooms, all wards were included.

Participants

All inpatients aged 18 or older who had given their informed consent and whose data were complete and available were included.

Outcome measure

Whether a patient had fallen in the hospital was retrospectively determined on the survey day by asking patients the following question: Have you fallen in this institution in the last 30 days?

Results

Based on data from 110 892 patients from 222 Swiss hospitals, a national inpatient fall rate of 3.7% was determined over the 9 survey years. A significant linear decreasing trend (p=0.004) was observed using the Cochran-Armitage trend test. After adjusting for patient-related fall risk factors in a two-level random intercept logistic regression model, a significant non-linear decreasing trend was found at the national level.

Conclusions

A significant decrease in fall rates in Swiss hospitals, indicating an improvement in the quality of care provided, could be confirmed both descriptively and after risk adjustment. However, the non-linear trend, that is, an initial decrease in inpatient falls that flattens out over time, also indicates a possible future increase in fall rates. Monitoring of falls in hospitals should be maintained at the national level. Risk adjustment accounts for the observed increase in patient-related fall risk factors in hospitals, thus promoting a fairer comparison of the quality of care provided over time.