The Observing a Decade of Yearly Standardised Surveillance in EVAR patients with Ultrasound or CT Scan study comprises a national multicentre retrospective cohort study in 17 medical centres. Consecutive patients with an asymptomatic or symptomatic infrarenal AAA who underwent EVAR between January 2007 and January 2012 will be included in this study with follow-up until December 2018. Clinical variables and all follow-up information will be retrieved in extensive data collection from the patient’s medical records. In addition, an e-survey was sent to vascular surgeons at the 17 participating centres to gauge their opinions regarding the possibility of safely reducing the frequency of imaging surveillance. Primary endpoints are intervention after EVAR and aneurysm-related mortality. The initial estimated sample size is 1997 patients.
The study has been approved by the Medical Ethics Review Committee of the Amsterdam UMC, location Academic Medical Centre, Amsterdam, the Netherlands. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journal.
The Netherlands Trial Registry, NL6953 (old: NTR28773).
We designed a prospective cohort study of individuals tested for LTBI, based on the data collected on all persons screened for LTBI as part of the 2017 congregate settings programme in South Korea. Four types of databases are kept: LTBI screening database (personal information and LTBI test results), national health information (NHI) database (socio-demographic data and comorbidities), public healthcare information system (PHIS) database, and the Korean national TB surveillance system database (TB outcomes). Information regarding LTBI treatment at private hospitals and public health centres is collected from NHI and PHIS databases, respectively. The screening data are cleaned, duplicates are removed, and, where appropriate, re-coded to analyse specific exposures and outcomes. The primary objective is to compare the number of active TB cases prevented within 2 years between participants undergoing treatment and not undergoing treatment in the LTBI screening programme in congregate settings. Cascade of care for LTBI diagnosis and treatment will be evaluated among those with a positive LTBI test result. A Cox proportional hazards model will be applied to determine the risk factors for developing active TB.
The protocol is approved by the institutional review boards of Incheon St. Mary’s Hospital, the Catholic University of Korea. Study results will be disseminated through peer-reviewed journals and conference presentations.
KCT0003905
We will systematically identify, appraise and summarise studies investigating the clinical and cost-effectiveness, and experiences of shock-absorbing flooring in hospitals and care homes. Our search will build on an extensive search conducted by a scoping review (inception to May 2016). We will search electronic databases (AgeLine, CINAHL, MEDLINE, NHS Economic Evaluation Database, Scopus and Web of Science; May 2016–present), trial registries and grey literature. We will conduct backward and forward citation searches of included studies, and liaise with study researchers. We will evaluate the influence of floors on fall-related injuries, falls and staff work-related injuries through randomised and non-randomised studies, consider economic and qualitative evidence, and implementation factors. We will consider risk of bias, assess heterogeneity and explore potential effect modifiers via subgroup analyses and sensitivity analyses. Where appropriate we will combine studies through meta-analysis. We will use the GRADE (Grading of Recommendations, Assessment, Development and Evaluations) approach to evaluate the quality of evidence and present the results using summary of findings tables, and adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guidelines.
We will follow the ethical principles of systematic review conduct, by attending to publication ethics, transparency and rigour. Our dissemination plan includes peer-reviewed publication, presentations, press release, stakeholder symposium, patient video and targeted knowledge-to-action reports. This review will inform decision-making around falls management in care settings and identify important directions for future research.
CRD42019118834.
To test the efficacy of OLPs in women suffering from PMS, a clinical randomised controlled trial including two OLP study groups (with and without treatment rationale) was designed to investigate on the effect on PMS. PMS symptoms are monitored on a daily basis via a symptom diary, adverse events are monitored intermittently. The study started in spring 2018 and patients will be included until a maximum of 150 participants are randomised. Besides the primary outcome PMS symptom intensity and interference, an array of further variables is assessed. Multilevel modelling will be used for data analyses.
Ethics approval was obtained from the Ethics Committee Northwest and Central Switzerland. Results of the main analysis and of secondary analyses will be submitted for publication in peer-reviewed journals.
(1) ClinicalTrials.gov (NCT03547661); (2) Swiss national registration (SNCTP000002809).
This is a multicentre study, with at least five centres located in five geographically diverse study sites participating in the recruitment, covering Europe, USA and Asia.
The study will include children aged between 6 months and 14 years, both with normal or abnormal visual development.
The project will be divided in two consecutive phases: design and training of an artificial intelligence (AI) algorithm to identify visual problems, and system development and validation. The study protocol will consist of a comprehensive ophthalmological examination, performed by an experienced paediatric ophthalmologist, and an exam of the visual function using a DIVE.
For the first part of the study, diagnostic labels will be given to each DIVE exam to train the neural network. For the validation, diagnosis provided by ophthalmologists will be compared with AI system outcomes.
The study will be conducted in accordance with the principles of Good Clinical Practice. This protocol was approved by the Clinical Research Ethics Committee of Aragón, CEICA, on January 2019 (Code PI18/346).
Results will be published in peer-reviewed journals and disseminated in scientific meetings.
Following the PRISMA approach, this systematic review will include quantitative, qualitative and mixed-methods studies addressing the provision of quality MNCH care by private sector providers. Eight databases (Cumulative Index to Nursing and Allied Health, EconLit, Excerpta Medica Database, International Bibliography of the Social Sciences, Popline, PubMed, ScienceDirect, Web of Science) and two websites will be searched for relevant studies published between 1 January 1995 and 30 June 2019. For inclusion, studies in low-income and middle-income countries must examine at least one of the following critical outcomes: maternal morbidity or mortality, newborn morbidity or mortality, child morbidity or mortality, quality of care, experience of care and service utilisation. Depending on the data, analyses could include meta-analysis, descriptive quantitative statistics, narrative synthesis and thematic synthesis. Quality will be assessed using tools for qualitative and quantitative studies.
Formal ethical approval is not required for this research, as the secondary data are not identifiable. Findings from this review will be used to develop models for effective collaboration of the private and public sectors in implementing quality of care for MNCH. In addition to publishing our findings in a peer-reviewed journal, the findings will be shared through the Quality of Care Network, relevant mailing lists, webinars and social media.
CRD42019143383
Included participants will be considered experts within the field as measured against a predefined eligibility criterion. Through an iterative multistage process, participants will rate their agreement with a list of clinical indicators and suggest any missing clinical indicators during each round. Agreement will be measured using a 5-point Likert scale. Descriptive statistics will be used to measure agreement; median, IQR and percentage of agreement. A priori consensus criteria will be defined for each round. Data analysis at the end of round three will enable a list of clinical indicators to be derived.
Ethical approval was gained from the University of Birmingham (ERN_19-1142). On completion of the study, findings will be disseminated in a peer-reviewed journal and presented at relevant conferences.
The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 1:1 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months.
This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses.
Netherlands Trial Register (NL7148).
Four nursing homes based in the Parma province, in Northern Italy, will be involved in this prospective, pragmatic, multicentre, 18-month quasiexperimental study (sequential design with two cohorts). The residents of two nursing homes will receive the MMU team care intervention. In case of urgent care needs, the nursing home physician will contact the hospital physician responsible for the MMU team by phone. The case will be triaged as (a) manageable by phone advice, (b) requiring urgent assessment by the MMU team or (c) requiring immediate emergency department (ED) referral. MMU team is composed of one senior physician and one emergency-medicine resident chosen within the staff of Internal Medicine and Critical Subacute Care Unit of Parma University-Hospital, usually with different specialty background, and equipped with portable ultrasound, set of drugs and devices useful in urgency. The MMU visits patients in nursing homes, with the mission to stabilise clinical conditions and avoid hospital admission. Residents of the other two nursing homes will receive usual care, that is, ED referral in every case of urgency. Study endpoints include unplanned hospital admissions (primary), crude all-cause mortality, hospital mortality, length of stay and healthcare-related costs (secondary).
The study protocol was approved by the Ethics Committee of Area Vasta Emilia Nord (Emilia-Romagna region). Informed consent will be collected from patients or legal representatives. The results will be actively disseminated through peer-reviewed journals and conference presentations, in compliance with the Italian law.
ClinicalTrials.gov Registry (NCT 04085679); Pre-results.
Parkinson’s disease is the second most common chronic neurodegenerative condition with bladder dysfunction affecting up to 71%. Symptoms affect quality of life and include urgency, frequency, hesitancy, nocturia and incontinence. Addressing urinary dysfunction is one of the top 10 priority research areas identified by the James Lind Alliance and Parkinson’s UK.
Conduct a randomised controlled trial (RCT) targeting people with Parkinson’s disease (PwP) who have self-reported problematic lower urinary tract symptoms, investigating the effectiveness of transcutaneous tibial nerve stimulation (TTNS) compared with sham TTNS. Implement a standardised training approach and package for the correct application of TTNS. Conduct a cost-effectiveness analysis of TTNS compared with sham TTNS.
An RCT of 6 weeks with twice weekly TTNS or sham TTNS. Participants will be recruited in 12 National Health Service neurology/movement disorder services, using a web-based randomisation system, and will be shown how to apply TTNS or sham TTNS. Participants will receive a weekly telephone call from the researchers during the intervention period. The trial has two coprimary outcome measures: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form and the International Prostate Symptom Score. Secondary outcomes include a 3-day bladder diary, quality of life, acceptability and fidelity and health economic evaluation. Outcomes will be measured at 0, 6 and 12 weeks.
A sample size of 208 randomised in equal numbers to the two arms will provide 90% power to detect a clinically important difference of 2.52 points on the Internatioanl Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and of 3 points in the International Prostate Symptom Score total score at 12 weeks at 5% significance level, based on an SD of 4.7 in each arm and 20% attrition at 6 weeks. Analysis will be by intention to treat and pre defined in a statistical analysis plan
East of Scotland Research Ethics Service (EoSRES), 18/ES00042, obtained on 10 May 2018. The trial will allow us to determine effectiveness, safety, cost and acceptability of TTNS for bladder dysfunction in PWP. Results will be published in open access journals; lay reports will be posted to all participants and presented at conferences.
ISRCTN12437878; Pre-results.
The research is designed as a multicentre, cross-sectional cohort study using quantitative methods to identify the relative cost predictors of home care and combine these into a casemix classification, based on individual episodes of care. The dependent variable in the analyses is the cost of home care utilisation, which is operationalised through various measures of formal and informal care, weighted by the relative wage rates of staff categories. As independent variables, we will use data from a recently developed Casemix Short-Form questionnaire, combined with client information from participating home care providers’ (nursing) classification systems and data on demographics and care category (ie, a classification mandated by health insurers). Cost predictors are identified using random forest variable importance measures, and then used to build regression tree models. The casemix classification will consist of the leaves of the (pruned) regression tree. Internal validation is addressed by using cross-validation at various stages of the modelling pathways. The Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis statement was used to prepare this study protocol.
The study was classified by an accredited Medical Research Ethics Committee as not subject to the Dutch Medical Research Involving Human Subjects Act. Findings are expected in 2020 and will serve as input for the development of a new payment system for home care in the Netherlands, to be implemented at the discretion of the Dutch Ministry of Health, Welfare and Sports. The results will also be published in peer-reviewed publications and policy briefs, and presented at (inter)national conferences.
This multicentre, randomised controlled trial will recruit 200 patients who have fusiform AAA ≥50 mm/rapidly enlarging fusiform AAA, with patent IMA, and randomly allocate them either to a pre-emptive IMA embolisation group or non-embolisation control group in a ratio of 1:1. The primary endpoint is the difference of aneurysm sac volume change assessed by CT scans between the pre-emptive IMA embolisation group and the control group at 12 months after EVAR. The secondary endpoints are defined as change of aneurysm sac volume in both groups at 6 and 24 months, freedom from sac enlargement at 12 and 24 months after EVAR, prevalence of type II EL at 1, 6, 12 and 24 months evaluated by contrast-enhanced CT, reintervention rate, aneurysm related mortality, overall survival, perioperative morbidity, volume of contrast media used during EVAR and dosage of radiation.
The protocol has been reviewed and approved by the ethics committee of Nara Medical University (No. 2113). The findings of this study will be communicated to healthcare professionals, participants and the public through peer-reviewed publications, scientific conferences and the University Hospital Medical Information Network Clinical Trials Registry home page.
UMIN000035502.
The primary aim is to assess the feasibility of delivering a weight management intervention for overweight/obese postnatal women within child immunisation appointments. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. General practitioner practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. Eighty women will be recruited. The intervention group will be offered brief support that encourages self-management of weight when attending child immunisation appointments. Practice nurses will encourage women to weigh themselves weekly and record this, and to make healthy lifestyle choices through using an online weight management programme. Women will be advised to aim for 0.5 to 1 kg/week weight loss. At each child immunisation the nurse will assess progress by weighing women. The comparator group will receive a healthy lifestyle leaflet. Data on weight, body fat, depression, anxiety, body image, eating behaviours and physical activity will be collected at baseline and follow-up. Women and nurses will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on prespecified stop-go criteria.
Data will be stored securely at the University of Birmingham. Results will be disseminated through academic publications and presentations and will inform a possible phase III trial. The National Research Ethics Committee approved the study protocol.
This biopsychosocial intervention randomised controlled trial will engage patients (n=156) diagnosed with type 2 diabetes mellitus (T2DM) from four primary healthcare clinics in Putrajaya. Participants will be randomised to either OHP plus treatment as usual. The 2-hour weekly sessions over five consecutive weeks, and 2-hour booster session post 3 months will be facilitated by trained mental health practitioners and diabetes educators. Primary outcomes will include self-efficacy measures, while secondary outcomes will include well-being, anxiety, depression, self-care behaviours and haemoglobin A1c glucose test. Outcome measures will be assessed at baseline, immediately postintervention, as well as at 3 months and 6 months postintervention. Where appropriate, intention-to-treat analyses will be performed.
This study has ethics approval from the Medical Research and Ethics Committee, Ministry of Health Malaysia (NMRR-17-3426-38212). Study findings will be shared with the Ministry of Health Malaysia and participating healthcare clinics. Outcomes will also be shared through publication, conference presentations and publication in a peer-reviewed journal.
This protocol has been approved by the Ethics Committee of Aragon (N° PI15/0017). The trial will be conducted in accordance with the Declaration of Helsinki.
Studies that investigated PA maintenance with a sample mean age ≥55 years will be included. Five electronic databases (PubMed, Cumulative Index to Nursing and Allied Health Literature, SPORTDiscus, PsycINFO and ProQuest Dissertations and Theses) were searched on 6 April 2018 with no publication date limit (ie, from inception). One reviewer screened 100% of titles and abstracts (k=21 470) while a random subsample (20%) was screened independently by two reviewers. An update of the search was run on 1 October 2019. All studies for which the full text was retrieved will be independently screened by two reviewers. Data pertaining to study sample, design, motives, PA (eg, measurement validity evidence, study definition of maintenance) and essential bias domains (eg, bias due to missing data) will be extracted. Study-level effect sizes will be calculated, and if the number of studies is ≥5, a random-effects meta-analysis will be performed using inverse-variance methods; a narrative synthesis will be performed otherwise.
The university’s Human Research Protection Program determined that the proposed study qualifies as exempt from the Institutional Review Board review under Exemption Category 4 (PROPEL #: 80047007). Results will be published in a peer-review journal, and the findings will help inform future interventions with older adults.
CRD42018088161.
In this multicenter, randomised, controlled phase 2 trial, we will randomly assign 120 women with early breast cancer undergoing chemotherapy to use of a dexamethasone-based elixir or standard oral care, to compare their preventive effects on chemotherapy-induced stomatitis. Patients will be assigned in a 1:1 ratio. Patients in the intervention group will receive chemotherapy, oral care and a dexamethasone-based elixir (10 mL 0.1 mg/mL; swish for 2 min and spit, four times daily for 9 weeks), and patients in the control group will receive chemotherapy and oral care. The primary endpoint is the difference in incidence of stomatitis between the two groups. The sample size allows for the detection of a minimum difference of 20% in the incidence of stomatitis between the two groups. Secondary endpoints are severity of stomatitis, duration of stomatitis, completion rate of chemotherapy and adverse events.
All participants signed a written consent form, and the study protocol has been reviewed and approved by the Clinical Research Review Board of Nagasaki University (CRB7180001).
UMIN Clinical Trials Registry (UMIN000030489).
In this 2-year, multicentre, open-label, real-world randomised controlled trial, 384 adults with severe and complex obesity (defined as body mass index ≥35 kg/m2 plus either prediabetes, type 2 diabetes, hypertension or sleep apnoea) will be randomised via a 2:1 ratio to receive either standard SWMS care (n=128) or standard SWMS care plus a targeted prescribing pathway for LIRA 3 mg with prespecified stopping rules at 16, 32 and 52 weeks (n=256).
The primary outcome is to compare the proportion of participants achieving a weight loss of ≥15% at 52 weeks with a targeted prescribing pathway versus standard care. Secondary outcomes include a comparison of (1) the weight loss maintenance at 104 weeks and (2) the budget impact and cost effectiveness between the two groups in a real-world setting.
The Health Research Authority and the Medicines and Healthcare products Regulatory Authority in UK, the Health Products Regulatory Authority in Ireland, the North West Deanery Research Ethics Committee (UK) and the St Vincent’s University Hospital European Research Ethics Committee (Ireland) have approved the study. The findings of the study will be published in peer-reviewed journals.
ClinicalTrials.gov—Identifier: NCT03036800.
European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.
Due to the nature of the proposed study, no ethical approval will be required. All data will be deposited in a cross-disciplinary public repository. It is anticipated the study findings could be relevant to a variety of audiences. Study findings will be disseminated at scientific conferences and published in peer-reviewed journals.
This prospective study will enrol 662 children (aged 21 days to <18 months) seeking treatment for TDD symptoms. Children will be treated with intravenous or intramuscular thiamine (100 mg daily for a minimum of 3 days) alongside other interventions deemed appropriate. Baseline assessments, prior to thiamine administration, include a physical examination, echocardiogram and venous blood draw for the determination of thiamine biomarkers. Follow-up assessments include physical examinations (after 4, 8, 12, 24, 36, 48 and 72 hours), echocardiogram (after 24 and 48 hours) and one cranial ultrasound. During the hospital stay, maternal blood and breast-milk samples and diet, health, anthropometric and socio-demographic information will be collected for mother–child pairs. Using these data, a panel of expert paediatricians will determine TRD status for use as the dependent variable in logistic regression models. Models identifying predictors of TRD will be developed and validated for various scenarios. Clinical prediction model performance will be quantified by empirical area under the receiver operating characteristic curve, using resampling cross validation. A frequency-matched community-based cohort of mother–child pairs (n=265) will serve as comparison group for evaluation of potential risk factors for TRD.
Ethical approval has been obtained from The National Ethics Committee for Health Research, Ministry of Health, Lao PDR and the Institutional Review Board of the University of California Davis. The results will be disseminated via scientific articles, presentations and workshops with representatives of the Ministry of Health.
This protocol describes a multisite randomised controlled trial comparing a 4-month long, nine-session BA and PST-informed rehabilitation intervention (BA/PS) against a time-matched, attention control condition. The overall objective is to assess the efficacy of BA/PS for enhancing breast cancer survivors’ activity participation and quality of life over time. A total of 300 breast cancer survivors reporting participation restrictions after completing curative treatment for stage 1–3 breast cancer within the past year will be recruited across two sites (Dartmouth-Hitchcock Medical Center and University of Alabama at Birmingham). Assessments are collected on enrolment (T1) and 8 (T2), 20 (T3) and 44 (T4) weeks later.
Study procedures are approved by the Committee for the Protection of Human Subjects at Dartmouth College, acting as the single Institutional Review Board of record for both study sites (STUDY 00031380). Results of the study will be presented at national meetings and submitted for publication in peer-reviewed journals.
NCT03915548; Pre-results.
Approval has been granted by the Norwegian Regional Committee for Ethics in Medical Research in Western Norway (REK 2015/57), and the Data Protection Agency in the Zealand region (REG-145-2017). Findings will be disseminated widely through peer-reviewed publications and to patients through patient organisations.
The study is conducted in accordance with the conditions of Monash Health HREC (RES-17-0000-168A). Findings from the trial will be disseminated through peer-reviewed publications and conference presentations.
V.7.0, 30 July 2019.
ACTRN12616000311459, Universal trial number: (UTN) U1111-1195-3515.
The study will take the form of a non-experimental, observational cohort design, where participants will be asked to complete four surveys (baseline, immediate follow-up, 1 month and 3 months). The primary outcomes of the study will be the feasibility of the initiative including acceptability and implementation. Secondary outcomes include knowledge uptake of methods to reduce risk of cannabis related harm, descriptive cannabis norms and changes in cannabis consumption.
The study was approved by the University of Calgary Conjoint Health Research Ethics Board (#REB18-1364). The investigators will develop a guideline outlining the Cannabis Café to assist in the replication of this initiative at other locations and publish the results from the study in a peer-reviewed manuscript.
PubMed, EMBASE.com, the Cochrane library, Web of Science and Chinese Biomedical Literature Database will be searched from inception to January 2019. We will include prospective randomised controlled trials (RCTs) that reported the subtypes of LMA and i-gel regardless of sample size. The risk of bias assessment of the included RCTs will be conducted according to the Cochrane Handbook V.5.1.0. A Bayesian NMA will be performed using WinBUGS V.1.4.3. Grading of Recommendations Assessment, Development and Evaluation will be used to explore the quality of evidence.
Ethics approval and patient consent are not required as this study is an NMA based on published trials. The results of this NMA will be submitted to a peer-reviewed journal for publication.
CRD42019127668.
Men and women with bipolar disorder (~200 cases) will be recruited and compared with participants with no history of bipolar disorder (~1500 controls) from the Geelong Osteoporosis Study. Both cases and controls will be drawn from the Barwon Statistical Division, south-eastern Australia. The Structured Clinical Interview for DSM-IV-TR Research Version, Non-patient edition is the primary diagnostic instrument, and psychiatric symptomatology will be assessed using validated rating scales. Demographic information and detailed lifestyle data and medical history will be collected via comprehensive questionnaires. Participants will undergo dual energy X-ray absorptiometry scans and other clinical measures to determine bone and body composition. Blood samples will be provided after an overnight fast and stored for batch analysis.
Ethics approval has been granted from Barwon Health Research Ethics Committee. Participation in the study is voluntary. The study findings will be disseminated via peer-reviewed publications, conference presentations and reports to the funding body.
This study has been granted ethical approval by North of Scotland Research Ethics Service. The results will be written up for publication and show whether to progress to an effectiveness trial where the primary outcome would be differences in low-density lipoprotein concentration.
This scoping review will use steps described by Arksey and O’Malley and Levac: (1) identifying the research question(s); (2) identifying relevant studies; (3) selecting the studies; (4) charting the data; (5) collating, summarising and reporting the results and (6) consulting with experts. Our findings will be reported according to the guidelines set by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.
Ethics review approval is not required for this project. Findings from this study will be presented to lay public, at scientific conferences and published in a peer-reviewed journal.
This trial was funded by Versus Arthritis and commenced on 1 September 2015 (Versus Arthritis 20831). National Research Ethic Committee approved this study on 30 October 2015 (15/WM/0359). It was registered on the International Standard Randomised Controlled Trial Number (ISRCTN) registry with reference number ISRCTN 13254422 on 28 October 2015. The first site opened to recruitment on 27 April 2016 and the trial was in active recruitment at the point of submitting the protocol paper. The results of this trial will be submitted to a peer-reviewed journal and will inform clinical practice with regard to the treatment of Achilles tendinopathy.
A prospective longitudinal cohort study will be conducted to examine the association between psychiatric symptoms, functioning and mental health and health service use of youth aged 16–18 as they transition out of child mental health services at age 18. We will recruit a sample of (n=350) participants from child and adolescent psychiatric programmes at two hospital and two community mental health sites and conduct assessments annually for 3 years using standardised measures of psychiatric symptoms, functioning and health service utilisation.
Ethics approval has been obtained at all four recruitment sites. We will disseminate the results through conferences, open access publications and webinars.
This study protocol was approved by the Ouest V Research Ethics Board. Results will be spread through peer-reviewed publications, and reported at suitable meetings.
The ClinicalTrials.gov registry .(NCT03591848).
A cluster randomised controlled design will be used with general practice clinics randomly assigned to either the intervention (n=12) or usual care group (n=12). Patients who are aged 18 and older, presenting for general practice care, will be eligible to participate. Eighty-three participants will be recruited at each clinic. Participants will be asked to complete a baseline survey administered on a touch screen computer at their GP clinic, and then a follow-up survey at 3, 6 and 12 months. Those attending usual care practices will receive standard care. GPs at intervention practices will complete an online Clinical e-Audit, and will be provided with provider and patient-directed resources for depression care. Patients recruited at intervention practices who score 10 or above on the Patient Health Questionnaire-9 will have feedback regarding their depression screening results and preferences for care provided to their GP. The primary analysis will compare the number of cases of depression between the intervention and control groups.
The study has been approved by the University of Newcastle Human Research Ethics Committee, and registered with Human Research Ethics Committees of the University of Wollongong, Monash University and University of New South Wales. Results will be disseminated through peer-reviewed journal publications and conference presentations.
ACTRN12618001139268; Pre-results.
The Central Adelaide Local Health Network Human Research Ethics Committee has approved the protocol for this RCT (HREC/17/RAH/433). The results will be disseminated via peer-reviewed publications and presentations at relevant conferences.
ACTRN12618001431213.
Staphylococci are the most commonly identified pathogens in bloodstream infections. Identification of Staphylococcus aureus in blood culture (SAB) requires a prompt and adequate clinical management. The detection of coagulase-negative staphylococci (CoNS), however, corresponds to contamination in about 75% of the cases. Nevertheless, antibiotic therapy is often initiated, which contributes to the risk of drug-related side effects. We developed a computerised clinical decision support system (HELP-CDSS) that assists physicians with an appropriate management of patients with Staphylococcus bacteraemia. The CDSS is evaluated using data of the Data Integration Cent ers (DIC) established at each clinic. DICs transform heterogeneous primary clinical data into an interoperable format, and the HELP-CDSS displays information according to current best evidence in bacteraemia treatment. The overall aim of the HELP-CDSS is a safe but more efficient allocation of infectious diseases specialists and an improved adherence to established guidelines in the treatment of SAB.
The study is conducted at five German university hospitals and is designed as a stepped-wedge cluster randomised trial. Over the duration of 18 months, 135 wards will change from a control period to the intervention period in a randomised stepwise sequence. The coprimary outcomes are hospital mortality for all patients to establish safety, the 90-day disease reoccurrence-free survival for patients with SAB and the cumulative vancomycin use for patients with CoNS bacteraemia. We will use a closed, hierarchical testing procedure and generalised linear mixed modelling to test for non-inferiority of the CDSS regarding hospital mortality and 90-day disease reoccurrence-free survival and for superiority of the HELP-CDSS regarding cumulative vancomycin use.
The study is approved by the ethics committee of Jena University Hospital and will start at each centre after local approval. Results will be published in a peer-reviewed journal and presented at scientific conferences.
DRKS00014320.
TJDBPS01 is a multicentre, prospective, randomised controlled, parallel-group, superiority trial in 14 centres with pancreatic surgery experts who have performed ≥104 TLPDs and OPDs. A total of 656 patients who will undergo PD are randomly allocated to the TLPD group or OPD group in a 1:1 ratio. The trial hypothesis is that TLPD has superior or equivalent safety and advantages in postoperative recovery compared with OPD. The primary outcome is the postoperative length of stay.
The Instituitional Review Board Approval of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology has approved this trial and will be routinely monitoring the trial at frequent intervals, as will an independent third-party organisation. Any results from this trial (publications, conference presentations) will be published in peer-reviewed journals and conference proceedings.
A cross-sectional exploratory study is being conducted using semistructured in-depth telephone interviews with 15–20 participants each from the following groups: (1) premenopausal patients with breast cancer younger than 40, diagnosed within last 5 years, (2) breast surgeons, (3) breast medical oncologists, (4) breast care nurses (5) fertility specialists and (6) fertility preservation nurses. Patients with breast cancer are being recruited from the joint Breast Service of three affiliated institutions of Victorian Comprehensive Cancer Centre in Melbourne, Australia—Peter MacCallum Cancer Centre, Royal Melbourne Hospital and Royal Women’s Hospital, and clinicians are being recruited from across Australia. Interviews are being audio recorded, transcribed verbatim and imported into qualitative data analysis software to facilitate data management and analyses.
The study protocol has been approved by Melbourne Health Human Research Ethics Committee, Australia (HREC number: 2017.163). Confidentiality and privacy are maintained at every stage of the study. Findings will be disseminated through peer-reviewed scholarly and scientific journals, national and international conference presentations, social media, broadcast media, print media, internet and various community/stakeholder engagement activities.
Either ethics approval or patient consent is not necessary, because this study will be based on literature. The results of this study will be published in a peer-reviewed journal.
CRD42019130659
The study is a feasibility study to inform the design of a full definitive randomised controlled trial to guide the most appropriate management of these injuries. Participants will be recruited from major trauma centres and randomly allocated to either operative or non-operative management of their injuries. A variety of outcome instruments, measuring health-related quality of life, functional outcome and pain, will be completed at several time points up to 12 months post injury. Qualitative interviews will be undertaken with participants to explore their views of the treatments under investigation and trial processes.
Eligibility and recruitment to the study will be analysed to inform the feasibility of a definitive trial. Completion rates of the measurement instruments will be assessed, as well as their sensitivity to change and the presence of floor or ceiling effects in this population, to inform the choice of the primary outcome for a definitive trial.
Ethical approval for the study was given by the South West—Central Bristol NHS Research Ethics Committee on 2nd July 2018 (Ref; 18/SW/0135). The study will be reported in relevant specialist journals and through presentation at specialist conferences.
We will document the penetrance of robotic versus open surgery in the urological oncological field using a national database.
Second, we will perform a systematic review and meta-analysis of all published full-text English and non-English language articles from Pubmed, Scopus and Web of Science search engines on surgical treatment of localised prostate, bladder, kidney and testis cancer published between 1st January 2000 to 10th January 2020. We will focus on the highest-volume urological oncological surgeries, namely, radical prostatectomy, radical cystectomy, partial nephrectomy, radical nephrectomy and retroperitoneal lymph node dissection. Study inclusion criteria will comprise clinical trials and prospective and retrospective studies (cohort or case–control series) comparing robotic versus open surgery. Exclusion criteria will comprise meta-analyses, multiple papers with overalapping study-periods, studies analysing national databases and case series describing only one approach (robotic or open). Risk of bias for included studies will be assessed by the appropriate Cochrane risk of bias tool. Principal outcomes assessed will include perioperative, functional, oncological survival and financial outcomes of open versus robotic uro-oncological surgery. Sensitivity analyses will be performed to correlate outcomes of interest with key baseline characteristics and surrogates of surgical expertise.
This comprehensive systematic review and meta-analysis will provide rigorous, consolidated information on contemporary outcomes and trends of open versus robotic urological oncological surgery based on all the available literature. These aggregate data will help physicians better advise patients seeking surgical care for urological cancers.
CRD42017064958.
Poor diet is a leading risk factor for non-communicable diseases and costs the National Health Service £5.8 billion annually. Product placement strategies used extensively in food outlets, like supermarkets, can influence customers’ preferences. Policy-makers, including the UK Government, are considering legislation to ensure placement strategies promote healthier food purchasing and dietary habits. High-quality scientific evidence is needed to inform future policy action. This study will assess whether healthier placement strategies in supermarkets improve household purchasing patterns and the diets of more than one household member.
This natural experiment, with a prospective matched controlled cluster design, is set in discount supermarkets across England. The primary objective is to investigate whether enhanced placement of fresh fruit and vegetables improves household-level purchasing of these products after 6 months. Secondary objectives will examine: (1) differences in intervention effects on purchasing by level of educational attainment, (2) intervention effects on the dietary quality of women and their young children, (3) intervention effects on store-level sales of fruit and vegetables and (4) cost-effectiveness of the intervention from individual, retailer and societal perspectives. Up to 810 intervention and 810 control participants will be recruited from 18 intervention and 18 matched control stores. Eligible participants will be women aged 18–45 years, who hold a loyalty card and shop in a study store. Each control store will be matched to an intervention store on: (1) sales profile, (2) neighbourhood deprivation and (3) customer profile. A detailed process evaluation will assess intervention implementation, mechanisms of impact and, social and environmental contexts.
Ethical approval was obtained from the University of Southampton, Faculty of Medicine Ethics Committee (ID 20986.A5). Primary, secondary and process evaluation results will be submitted for publication in peer-reviewed scientific journals and shared with policy-makers.
Children with (n=300) and without HIV (n=300), aged 8–16 years, established on ART, will be recruited into a frequency-matched prospective cohort study and compared. Musculoskeletal assessments including dual-energy X-ray absorptiometry, peripheral quantitative computed tomography, grip strength and standing long jump will be conducted at baseline and after 1 year. Linear regression will be used to estimate mean size-adjusted bone density and Z-scores by HIV status (ie, total-body less-head bone mineral content for lean mass adjusted for height and lumbar spine bone mineral apparent density. The prevalence of low size-adjusted BMD (ie, Z-scores <–2) will also be determined.
Ethical approval for this study has been granted by the Medical Research Council of Zimbabwe and the London School of Hygiene and Tropical Medicine Ethics Committee. Baseline and longitudinal analyses will be published in peer-reviewed journals and disseminated to research communities.
This pre–post pilot study will develop a motivational interviewing (MI) virtual client training tool for health professionals and test the effectiveness of the educational content and usability of the virtual client interaction.
Postgraduate students across a range of health disciplines will be recruited. Data assessing attitudes towards preventive healthcare will be collected using a modified version of the Preventive Medicine Attitudes and Activities Questionnaire. Conversations with the virtual client will be analysed using the Motivational Interviewing Treatment Integrity code to assess changes in MI skills. The System Usability Scale will be used to assess the usability of the virtual client training tool.
This protocol was approved by the Flinders University Social and Behavioural Research Ethics Committee in May 2019. The results of the pilot study will inform the development of an avatar-based mobile application consisting of MI teaching and interactions with a generic virtual client that can be easily adapted to multiple scenarios.
According to Preferred Reporting Items for Systematic Reviews and Meta-Analyses, a systematic review and meta-analysis will be conducted from 10th to 17th January 2020. Independent reviewers will search published/unpublished studies through electronic databases (Scopus, PubMed, EMBASE and the Cochrane Library) and additional sources, will extract the data and assess the methodological quality through the Newcastle-Ottawa Scale. Random-effect meta-analysis will be carried out by calculating effect sizes as Cohen’s d indices. Publication bias will be assessed and moderators of the effect sizes will be investigated through weighted least squares meta-regression.
The knowledge whether health-related quality of life is better or worse as a function of some individual characteristics may suggest personalised care pathways according to a precision medicine approach.
The current review does not require ethics approval. The results will be disseminated through publications in peer-reviewed journals.
CRD42019131749
The current study was approved by the board of research ethics of Peking University Third Hospital Medical Science Research Ethics Committee. The results of this study will be presented at national and international conferences and published in peer-reviewed journals.
This feasibility study will examine the effectiveness of a brief self-compassion intervention, compared with a waitlist control group. Participants aged 12–16 years will be recruited from three diabetes outpatient clinics in Auckland, New Zealand. The brief self-compassion intervention is adapted from the standardised ‘Making Friends with Yourself’ intervention and will be delivered in a group format over two sessions. Apart from examining feasibility and acceptability through the flow of participants through the study and qualitative questions, we will assess changes to disordered eating behaviour (primary outcome), self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control (secondary outcomes). Such data will be used to calculate the required sample size for a fully powered randomised controlled trial.
This trial has received ethics approval from the Health and Disability Ethics Committee (research project number A+8467). Study results will be disseminated through peer-reviewed journals and conferences.
ANZCTR (12619000541101).
Ethical approval for the study was granted by the New Zealand Health and Disability Ethics Committee (reference 19/STH/69) on 23 June 2019 for Protocol V.1.2. Trial results will be reported in a peer-reviewed journal, and results presented at scientific conferences or meetings.
Healthcare and Medical Sciences Academic Ethics Committee (Reference 2018-16308) and NHS Wales Research Ethics Committee 5 approval (References 256 729 and 262726) have been obtained. A knowledge mobilisation event will address issues relevant to wider implementation of the intervention and study findings. Findings will be disseminated through peer-reviewed journal publications, conference presentations and formal and informal reports.
CRD42018103027.
University Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.
In patients with mild AD who test positive for HSV1 or HSV2 serum antibodies, valacyclovir, repurposed as an anti-AD drug, will be compared with placebo (lactose pills) in 130 patients (65 valacyclovir and 65 placebo) in a randomised, double-blind, 78-week phase II proof-of-concept trial. Patients on valacyclovir, dose-titrated from 2 g to a targeted oral dose of 4 g daily, compared with placebo, are hypothesised to show smaller cognitive and functional decline, and, using 18F-Florbetapir positron emission tomography (PET) and 18F-MK-6240 PET imaging, to show less amyloid and tau accumulation, respectively. In the lumbar puncture subsample, cerebrospinal fluid acyclovir will be assayed to assess central nervous system valacyclovir penetration.
The trial is being overseen by the New York State Psychiatric Institute Institutional Review Board (protocol 7537), the National Institute on Ageing, and the Data Safety Monitoring Board. Written informed consent is obtained for all subjects. Results will be disseminated via publication, clinicaltrials.gov, media and conferences.
ClinicalTrials.gov identifier (NCT03282916) Pre-results.
No ethical approval will be required. Findings from this study will be published in a peer-reviewed journal. All data will be deposited in a cross-disciplinary public repository.
CRD42019148152.
The RAPID-ADPKD (Retrospective epidemiological study of Asia-Pacific patients with rapId Disease progression of Autosomal Dominant Polycystic Kidney Disease) study is a multinational, retrospective, observational cohort study of patients with ADPKD in the Asia-Pacific region (Australia, China, Hong Kong, South Korea, Taipei and Turkey). This study was designed to identify the clinical characteristics of patients with ADPKD with rapid disease progression. Adult patients with ADPKD diagnosed according to the unified ultrasound criteria and with an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73 m2 at baseline will be included. The cohort will include patients with ≥2 records of eGFR and at least 24 months of follow-up data. Demographic information, clinical characteristics, comorbidities, medications, eGFR, radiological findings that allow calculation of height-adjusted total kidney volume, ADPKD-related complications and the Predicting Renal Outcomes in autosomal dominant Polycystic Kidney Disease (PRO-PKD) score will be collected. Rapid progression will be defined based on the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) guideline. All other patients without any of these criteria will be classified to be of slow progression. Clinical characteristics will be compared between patients with rapid progression and those with slow progression. The incidence of complications and the effects of race and water intake on renal progression will also be analysed. The planned sample size of the cohort is 1000 patients, and data from 600 patients have been collected as of 30 May 2019.
This study was approved or is in the process of approval by the institutional review boards at each participating centre. The results will be presented in conferences and published in a journal, presenting data on the clinical characteristics, risk factors for disease progression and patterns of complications of ADPKD in Asian populations.
The Ethics Review Board of Hokkaido University Hospital has approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences.
The University Hospital Medical Information Network (UMIN000031451); Japan Registry of Clinical Trials (jRCTs011180019); Pre-results.
This international, prospective, open label, randomised controlled trial aims to recruit 1800 ESKD adults treated with HD in nine European countries. Patients will be randomised 1:1 to high-dose HDF versus continuation of conventional high-flux HD. The primary outcome will be all-cause mortality at 3 years’ follow-up. Secondary outcomes will include cause-specific mortality, cardiovascular events, all-cause and infection-related hospitalisations, patient-reported outcomes (eg, health-related quality of life) and cost-effectiveness.
The CONVINCE study will address the question of benefits and harms of high-dose HDF compared to high-flux HD for kidney replacement therapy in patients with ESKD with a focus on survival, patient perspectives and cost-effectiveness.
Netherlands National Trial Register (NTR 7138).
The aim of this systematic review is to identify assessment instruments of PC in the multimorbid elderly, using a subgroup-specific definition of PC (‘subgroup-specific integrative model of PC’) as the conceptual underpinning, and to provide a critical quality appraisal of their psychometric properties.
A comprehensive systematic literature search for assessment tools on PC will be conducted in the MEDLINE, CINAHL, EMBASE, PsycINFO, Web of Science and PSYNDEX electronic databases. The search strategy will be informed by the subgroup-specific integrative model of PC. The electronic literature search will be complemented by a hand-search combining citation tracking, search in project databases, and contacting authors from relevant studies/reviews. The literature search (systematic and hand-search) will cover the period from November, 2018 to December 2019.
The retrieval of relevant studies will be conducted via title screening, abstract screening, and full-text eligibility assessment applying defined inclusion criteria. Full texts will be independently assessed by two team members. Data from the included articles will be extracted using a standardised extraction form and evaluated based on the COSMIN methodology for systematic reviews of patient-reported outcome measures, which focuses on the methodological quality of included studies as well as on the measurement properties of the assessment instruments. Data extraction and quality assessment will be conducted by two independent reviewers.
The study has received approval from the Ethics Committee of the University of Freiburg (reference number 587/17). The results of the project will be disseminated via scientific oral presentations at national and international conferences and will be published in scientific journals.
CRD42018084057; DRKS00013309.
Approval was gained from NRES Committee London (REC reference 17/LO/1447). Findings will be disseminated by various methods including international presentations and publication in a peer-reviewed journal.
ClinicalTrials.gov Registry (NCT04058626).
The protocol (version number: 2.0, 10 April 2019) has been approved by the Ethics Review Committee of China Registered Clinical Trials (Ethics Review No. ChiECRCT-20190047). The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.
NET-02 is a UK, multicentre, randomised (1:1), parallel group, open-label, phase II, single-stage selection trial of liposomal irinotecan (nal-IRI)/5-fluorouracil (5-FU)/folinic acid or docetaxel as second-line therapy in patients with progressive PD-EP-NEC. One hundred and two eligible participants will be randomised to receive either nal-IRI/5-FU/folinic acid or docetaxel. The primary objective is to determine the 6-month progression-free survival (PFS) rate. The secondary objectives of this study are to determine PFS, overall survival, objective response rate, toxicity, quality of life and whether neuron-specific enolase is predictive of treatment response. If either treatment is found to have a 6-month PFS rate of at least 25%, that treatment will be considered for a phase III trial. If both treatments meet this target, prespecified selection criteria will be applied to establish which treatment to take forward.
This study has ethical approval from the Greater Manchester Central Research Ethics Committee (reference no. 18/NW/0031) and clinical trial authorisation from the Medicine and Healthcare Products Regulatory Agency. Results will be published in peer-reviewed journals and uploaded to the European Union Clinical Trials Register.
ISRCTN10996604,
This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia. Those in the intervention group will complete 1–2 weeks of CCT preoperatively (45–60 min sessions, 3.5 sessions/week) and 12 weeks of CCT postoperatively (commencing 1 month following surgery, 45–60 min sessions, 3 sessions/week). All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1 year. The primary delirium outcome variable will be delirium incidence (presence vs absence); the primary cognitive decline variable will be at 4 months (significant decline vs no significant decline/improvement from baseline). Logistic regression modelling will be used, with age and gender as covariates. Secondary outcomes include cognitive decline from baseline to discharge, and at 6 months and 1 year post-CABG.
Ethics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee (South Australia, Australia) and the University of South Australia Human Ethics Committee, with original approval obtained on 13 December 2017. It is anticipated that approximately two to four publications and multiple conference presentations (national and international) will result from this research.
This clinical trial is registered with the Australian New Zealand Clinical Trials Registry and relates to the pre-results stage. Registration number: ACTRN12618000799257.
The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations.
The Netherlands Trial Registry (NL8029); Pre-results.
Ethical approval was obtained from the University of British Columbia (H18-00768) and Universiti Putra Malaysia (JKEUPM-2018-255). The results of this trial will be presented at scientific conferences and published in peer-reviewed journals.
ACTRN12619000818134 and NMRR-19-119-45736.
This protocol is reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) checklist. We will include any randomised controlled trials or quasi-experimental studies with a pre/post design conducted in adults ≥18 years of age that report on the effectiveness of a social media or mHealth intervention on screening participation or intention (inclusive of breast, cervical, colorectal, prostate and lung cancer). Interventions will be inclusive of those delivered online or through a computer using an established social media platform or a new purpose-built platform, or those delivered through cellphones or other wireless technologies. Any comparator will be acceptable (control group, alternate intervention or pre/post design). We will search Medline, EMBASE, PsycINFO, Scopus, CINAHL, the Cochrane Central Register of Controlled Trials, and Communication and Mass Media Complete from 1 January 2000 to 31 May 2019. Two independent reviewers will screen titles, abstracts and full-text articles with conflicts resolved through discussion or by a third reviewer, as needed. The two reviewers will also independently complete risk of bias assessments for each included study. We will report on the characteristics of the studies, participants and interventions in descriptive narrative form and report the absolute and relative differences in screening and intention attributable to social media and mobile technology interventions.
As this is a systematic review, ethical approval for conduct of this study is not required. We will pursue publication of study results in a relevant peer-reviewed journal and report our findings according to the PRISMA checklist.
CRD42019139615.
A multimethod approach will be used in a cross-sectional process evaluation of the CCMDD programme at 11 PHC facilities in Namakwa district. These methods will use checklists to assess programme compliance and subsequently gain an understanding of whether the programme was implemented as planned. Structured questionnaires together with focus group discussions will be conducted with selected patients enrolled in the programme and facility staff to determine patient experiences with and staff expectations of the programme, respectively. Furthermore, in-depth interviews will be conducted with key actors to explore barriers and facilitators of the programme implementation. Descriptive statistics will be conducted to analyse the quantitative data and an inductive interpretive approach will be used to analyse the qualitative data.
The protocol was approved by Stellenbosch University Health Research Ethics Committee (S19/02/047) and the study will be conducted in line with the principles of the Declaration of Helsinki (1964). Findings from the study will be communicated to the study population, and at appropriate local and international conferences, in addition to publishing in peer-reviewed journals.
The study was reviewed and approved by the Ethics Review Boards of the participating centres. Eligible women will sign a written informed consent before enrolment. This study has an independent data monitoring and safety committee comprised international experts in trial design and in vitro culture. No plan exists to disseminate results to participants or health communities, except for the independent monitoring and safety committee of the trial.
The benefits of palliative care rely on how healthcare professionals assess patients’ needs in the initial encounter/s; crucial to the design of a personalised therapeutic plan. However, there is currently no evidence-based guideline to perform this needs assessment. We aim to design and evaluate a proactive and systematic method for the needs assessment using quality guidelines for developing complex interventions. This will involve patients, their relatives and healthcare professionals in all phases of the study and its communication to offer clinical practice a reliable approach to address the palliative needs of patients.
To design and assess the feasibility of an evidence-based, proactive and systematic Multidimensional needs Assessment in Palliative care (MAP) as a semistructured clinical interview guide for initial palliative care encounter/s in patients with advanced cancer. This is a two-phase multisite project conducted over 36 months between May 2019 and May 2022. Phase I includes a systematic review, discussions with stakeholders and Delphi consensus. The evidence gathered from phase I will be the basis for the initial versions of the MAP, then submitted to Delphi consensus to develop a preliminary guide of the MAP for the training of clinicians in the feasibility phase. Phase II is a mixed-methods multicenter feasibility study that will assess the MAP’s acceptability, participation, practicality, adaptation and implementation. A nested qualitative study will purposively sample a subset of participants to add preliminary clues about the benefits and barriers of the MAP. The evidence gathered from phase II will build a MAP user guide and educational programme for use in clinical practice.
Ethical approval for this study has been granted by the university research ethics committee where the study will be carried out (approval reference MED-2018-10). Dissemination will be informed by the results obtained and communication will occur throughout.
The UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of ‘usual care’. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model.
The primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context.
ACTRN12617001595303; Pre-results.
Ethics in participatory approaches include a careful focus on the power relationships within the group, such that all groups are given voice and influence, in addition to the usual considerations of informed participation. Within the programme, we will focus on reflexivity, relationship building, two-way learning and learning from failure to reduce power imbalances and mitigate against a blame culture. Local engagement and change will be prioritised in dissemination.
The following electronic databases: MEDLINE via PubMed, SCOPUS (which included contents of Embase), PsycINFO, CINAHL, Africa-Wide Information, PsycARTICLES, Health source: Nursing/Academic Edition, Academic Search Premier and SocINDEX all via the EBSCOHOST platform, the Latin American and Caribbean Health Sciences Literature, the Cochrane Centre Register of Controlled Trials) and grey literature sources will be searched between May and December 2019. Eligible studies will be independently screened for inclusion and exclusion by two reviewers using a checklist developed for this purpose. Studies published between January 1993 and November 2019 that focus on recovery from severe mental illness in a low-income and middle-income country will be included. Findings will be compared and discrepancies will be discussed. Unresolved discrepancies will be referred to a third reviewer. All bibliographic data and study characteristics will be extracted and thematically analysed using a tool developed through an iterative process by the research team. Indicators will be classified according to a predefined conceptual framework and categorised and described using qualitative content analysis.
The review aims to synthesise information from available publications, hence it does not require ethical approval. The results will be disseminated through publications, conference presentations and future workshops with stakeholders involved within the recovery paradigm of mental health policy and practice. The scoping review title is registered with the Joanna Briggs Institute.
The search strategy has been developed by a Health Scientist Librarian in collaboration with the review team. The search was conducted on 1st October 2019.
Database subject headings and text words relating to ‘abdominal/general surgeons’, ‘personality’, ‘postoperative outcomes’ and ‘decision making’ formed the basis of our literature search strategy; the MEDLINE, EMBASE, PsycInfo and Cochrane databases will be searched. Three reviewers will independently screen and appraise articles, with a fourth reviewer utilised if disagreements arise.
A systematic narrative synthesis will be performed, with information presented in text and table format. These will summarise the findings and characteristics of any included studies. Using guidance from the Centre for Reviews and Dissemination, the reviewers will describe the potential relationship and findings between studies using the narrative synthesis. Studies will only be reported if they are felt to have low or mid-levels of bias. Studies felt to display high levels of bias will be excluded.
This study does not require ethical approval. The formal systematic review will be submitted for peer reviewed publication and presented at relevant conferences. The methods may inform future reviews in other surgical specialties regarding surgeon personality.
CRD42019151375.