Patterns and predictors of high-cost users of the health system: a data linkage protocol to combine a cohort study and randomised controlled trial of adults with a history of homelessness

IntroductionHomelessness is a global issue with a detrimental impact on health. Individuals who experience homelessness are often labelled as frequent healthcare users; yet it is a small group of individuals who disproportionately use the majority of services. This protocol outlines the approach to combine survey data from a prospective cohort study and randomised controlled trial with administrative healthcare data to characterise patterns and predictors of healthcare utilisation among a group of adults with a history of homelessness.Methods and analysisThis cohort study will apply survey data from the Health and Housing in Transition study and the At Home/Chez Soi study linked with administrative healthcare databases in Ontario, Canada. We will use count models to quantify the associations between baseline predisposing, enabling, and need factors and hospitalisations, emergency department visits and physician visits in the following year. Subsequently, we will identify individuals who are high-cost users of the health system (top 5%) and characterise their patterns of healthcare utilisation. Logistic regression will be applied to develop a set of models to predict who will be high-cost users over the next 5 years based on predisposing, enabling and need factors. Calibration and discrimination will be estimated with bootstrapped optimism (bootstrap performance—test performance) to ensure the model performance is not overestimated.Ethics and disseminationThis study is approved by the St Michael’s Hospital Research Ethics Board and the University of Toronto Research Ethics Board. Findings will be disseminated through publication in peer-reviewed journals, presentations at research conferences and brief reports made available to healthcare professionals and the general public.Trial Registration NumberThis is a secondary data analysis of a cohort study and randomized trial. The At Home/Chez Soi study has been registered with the International Standard Randomised Control Trial Number Register and assigned ISRCTN42520374.

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Protocol for a randomised controlled trial for Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance (TITAN: SvS)

BMJ Open ◽

10.1136/bmjopen-2021-052070 ◽

2021 ◽

Vol 11 (5) ◽

pp. e052070

Author(s):

Ming Hao Guo ◽

Jehangir J Appoo ◽

George A Wells ◽

Michael Chu ◽

Maral Ouzounian ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Aortic Aneurysm ◽

Research Ethics ◽

Thoracic Aortic Aneurysm ◽

Controlled Trial ◽

Health Science ◽

Aneurysm Surgery ◽

Research Ethics Board ◽

Randomised Controlled ◽

Aortic Aneurysm Surgery

IntroductionAscending thoracic aortic aneurysm (ATAA) is an asymptomatic condition that can lead to catastrophic events of rupture or dissection. Current guidelines are based on limited retrospective data and recommend surgical intervention for ATAA with a diameter of greater or equal to 5.5 cm. Treatment in Thoracic Aortic Aneurysm: Surgery versus Surveillance is the first prospective, multicentre, randomised controlled trial that compares outcomes of patients undergoing early elective ascending aortic surgery to patients undergoing medical surveillance.Methods and analysisPatients between the ages of 18 and 80 with an asymptomatic ATAA between 5.0 cm and 5.4 cm in diameter are eligible for randomisation to early surgery or surveillance. Patients in the surgery group will be followed at 1 month after discharge, then annually for a minimum of 2 years and up to 5 years. Patients in the surveillance group will be followed annually from their index clinic visit for a minimum of 2 years and up to 5 years. The primary outcome is all-cause mortality at follow-up. A sample size of 618 subjects (309 in each group) will achieve an 80% power at a 0.047 significance level.Ethics and disseminationThis study has received Ottawa Health Science Network Research Ethics Board approval (Protocol 20180007-01H), which was most recently updated on 25 November 2020. The Research Ethics Board have granted approval to the study at 14 participating institutions, including the Ottawa Health Science Network Research Ethics Board. On completion of data analysis, the result of the trial will be presented at national and international conferences, and published in relevant journals, regardless of the finding of the trial.Trial registration numberNCT03536312.

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Study protocol for Vitality: a proof-of-concept randomised controlled trial of exercise training or complex mental and social activities to promote cognition in adults with chronic stroke

BMJ Open ◽

10.1136/bmjopen-2018-021490 ◽

2018 ◽

Vol 8 (3) ◽

pp. e021490 ◽

Cited By ~ 3

Author(s):

John R Best ◽

Janice J Eng ◽

Jennifer C Davis ◽

Robin Hsiung ◽

Peter A Hall ◽

...

Keyword(s):

Cognitive Function ◽

Randomised Controlled Trial ◽

Exercise Training ◽

Research Ethics ◽

Controlled Trial ◽

Chronic Stroke ◽

Intervention Strategies ◽

Proof Of Concept ◽

Research Ethics Board ◽

Randomised Controlled

IntroductionCerebrovascular disease—such as stroke—is the second most common cause of dementia (ie, vascular dementia). Specifically, a stroke increases one’s risk for dementia by a factor of two. Thus, stroke survivors represent a target population in need of intervention strategies to promote cognitive function and prevent dementia. The current standard of care in stroke rehabilitation does not adequately address the significant cognitive consequences of stroke, especially for those who are in the chronic phase (ie, >12 months since an index stroke). Two potential intervention strategies are: (1) exercise training and (2) cognitive and social enrichment activities.Methods and analysisThe aim of this proof-of-concept randomised controlled trial is to determine whether a 6-month targeted exercise training programme or a 6-month cognitive and social enrichment programme can efficaciously and efficiently improve cognitive function in older adults with chronic stroke compared with a 6-month stretch and tone programme (ie, control). The primary measurement periods will be baseline, month 6 (postintervention) and month 12 (6-month follow-up). The primary outcome measure will be performance on the Alzheimer’s Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-Plus), a global measure of cognitive performance using multidimensional item response theory to summarise scores from the 13-item ADAS-Cog and other standard cognitive assessments. The primary analysis will compare changes in ADAS-Cog-Plus performance from baseline to month 6. Proof-of-concept outcomes relating to intervention feasibility will be analysed descriptively. The economic evaluation will examine the incremental costs and health outcome benefits generated by both interventions versus the control.Ethics and disseminationEthical approval has been obtained from the University of British Columbia’s Clinical Research Ethics Board (H13-00715, 26 July 2013). Any modifications to the protocol will require a formal amendment to the protocol and approval by the Research Ethics Board. Outcomes of this randomised controlled trial and the statistical code to generate those outcomes will be disseminated through publication in peer-reviewed journals as well as conference presentations.Trial registration numberNCT01916486.

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Endoscopic polypectomy performed in clinic for chronic rhinosinusitis with nasal polyps: study protocol for the EPIC multicentre randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2020-042413 ◽

2020 ◽

Vol 10 (12) ◽

pp. e042413

Author(s):

Shaun Kilty ◽

Kednapa Thavorn ◽

Arif Janjua ◽

John Lee ◽

Kristian MacDonald ◽

...

Keyword(s):

Surgical Treatment ◽

Randomised Controlled Trial ◽

Research Ethics ◽

Chronic Rhinosinusitis ◽

Nasal Polyps ◽

Controlled Trial ◽

Sinus Surgery ◽

Endoscopic Polypectomy ◽

Research Ethics Board ◽

Randomised Controlled

IntroductionChronic rhinosinusitis (CRS) is common, with a Canadian prevalence of 5%, and associated with significant morbidity. Understandably, CRS impairs workplace productivity but that productivity substantially increases following surgical treatment. CRS with nasal polyps (CRSwNP), the most common type of CRS, is usually treated with a combination of medications and endoscopic sinus surgery (ESS). Historically, surgical treatment has only been performed in the operating room at a cost of about $C3500. However, recent studies have shown that a de-escalated procedure, endoscopic polypectomy performed in clinic (EPIC), can provide an improvement in patient symptoms to levels equal to those for ESS. Moreover, EPIC has additional proposed advantages including shorter recovery time, significantly lower cost to the healthcare system and shorter wait time for the patient. There is currently insufficient evidence to draw conclusions about the superiority of polypectomy or ESS for the management of CRSwNP.Methods and analysisWe designed a multicentre, open-label, randomised controlled trial to evaluate whether EPIC was non-inferior to the current clinical standard, ESS for the treatment of CRSwNP. The primary outcome is the Sinonasal Outcome Test-22 score measured at baseline and at 3 months after surgery. Other outcomes include peak nasal inspiratory flow, quality of life measured by the EuroQoL 5 Dimensions 5 Levels questionnaire and work impairment using the Work Productivity and Activity Impairment Questionnaire.We aim to recruit 140 patients from sites across Canada. Participants will be randomly assigned to EPIC or ESS and followed up for 3 months in clinic after the procedure. Additionally, participants will enter a 5-year long-term follow-up period.Ethics and disseminationThis study was approved by the Ottawa Health Sciences Network Research Ethics Board for all sites in Ontario, Canada (study number CTO0801). Sites located outside of Ontario obtained approval from their local/institutional research ethics board.Trial registration numberNCT02975310.

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Effectiveness and cost of integrating a pragmatic pathway for prescribing liraglutide 3.0 mg in obesity services (STRIVE study): study protocol of an open-label, real-world, randomised, controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-034137 ◽

2020 ◽

Vol 10 (2) ◽

pp. e034137 ◽

Cited By ~ 1

Author(s):

Dimitris Papamargaritis ◽

Werd Al-Najim ◽

Jonathan Lim ◽

James Crane ◽

Mike Lean ◽

...

Keyword(s):

Weight Loss ◽

Randomised Controlled Trial ◽

Research Ethics ◽

Real World ◽

Regulatory Authority ◽

Controlled Trial ◽

Ethics Committee ◽

Stopping Rules ◽

Open Label ◽

Randomised Controlled

IntroductionIn the UK and Ireland, severe and complex obesity is managed in specialist weight management services (SWMS), which provide multicomponent lifestyle interventions to support weight loss, and use of medication if available. Liraglutide 3 mg (LIRA 3 mg) is an effective weight-loss medication, but weight loss in individual patients is variable, and its efficacy has not been assessed in SWMS. This study aims to investigate whether a targeted prescribing pathway for LIRA 3 mg with multiple prespecified stopping rules could help people with severe obesity and established complications achieve ≥15% weight loss in order to determine whether this could be considered a clinically effective and cost-effective strategy for managing severe and complex obesity in SWMS.Methods and analysisIn 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/m2plus 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.Ethics and disseminationThe 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.Trial registration numberClinicalTrials.gov—Identifier:NCT03036800.European Clinical Trials Database—Identifier: EudraCT Number 2017-002998-20.

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Functional improvements after a pilates program in adolescents with a history of back pain: A randomised controlled trial

Complementary Therapies in Clinical Practice ◽

10.1016/j.ctcp.2019.01.006 ◽

2019 ◽

Vol 35 ◽

pp. 1-7 ◽

Cited By ~ 4

Author(s):

Noelia González-Gálvez ◽

Pablo J. Marcos-Pardo ◽

María Carrasco-Poyatos

Keyword(s):

Back Pain ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

History Of ◽

Randomised Controlled

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Acceptability and feasibility of two interventions in the MooDFOOD Trial: a food-related depression prevention randomised controlled trial in overweight adults with subsyndromal symptoms of depression

BMJ Open ◽

10.1136/bmjopen-2019-034025 ◽

2020 ◽

Vol 10 (9) ◽

pp. e034025

Author(s):

Matthew Owens ◽

Edward Watkins ◽

Mariska Bot ◽

Ingeborg Annemarie Brouwer ◽

Miquel Roca ◽

...

Keyword(s):

Depressive Symptoms ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Secondary Outcome ◽

Depression Prevention ◽

History Of ◽

Randomised Controlled ◽

Subsyndromal Symptoms ◽

Overweight Adults ◽

History Of Depression

ObjectivesWe report on the acceptability, feasibility, dose-response relationship and adherence of two nutritional strategies to improve mood (multinutrient supplements; food-related behavioural activation (F-BA)) studied in a randomised controlled depression prevention trial (the Multi‐country cOllaborative project on the rOle of Diet, Food‐related behaviour, and Obesity in the prevention of Depression (MooDFOOD) Trial). We also assessed baseline determinants of adherence and assessed whether better adherence resulted in lower depressive symptoms.DesignRandomised controlled trial with a 2×2 factorial design conducted between 2015 and 2017.SettingGermany, the Netherlands, UK and Spain.ParticipantsCommunity sample of 1025 overweight adults with elevated depressive symptoms without a current episode of major depressive disorder. Main eligibility criteria included age (18–75 years), being overweight or obese, and having at least mild depressive symptoms, shown by a Patient Health Questionnaire Score of ≥5. A total of 76% of the sample was retained at the 12-month follow-up.InterventionsDaily nutritional supplements versus pill placebo or an F-BA therapy, delivered in individual and group sessions versus no behavioural intervention over a 1-year period.Primary and secondary outcome measuresPrimary outcome: self-reported acceptability of the interventions. Secondary outcomes: adherence and self-reported depressive symptoms.ResultsMost participants reported that the F-BA was acceptable (83.61%), feasible to do (65.91%) and would recommend it to a friend (84.57%). Individual F-BA sessions (88.10%) were significantly more often rated as positive than group F-BA sessions (70.17%) and supplements (28.59%). There were statistically significant reductions in depressive symptoms for those who both adhered to the F-BA intervention and had a history of depression (B=−0.08, SE=0.03, p=0.012) versus those who had no history of depression. Supplement intake had no effect on depressive symptoms irrespective of adherence.ConclusionsF-BA may have scope for development as a depression prevention intervention and public health strategy but further refinement and testing are needed.Trial registration numberNCT02529423.

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SOMA-trial: surgery or medication for women with an endometrioma? Study protocol for a randomised controlled trial and cohort study

Human Reproduction Open ◽

10.1093/hropen/hoz046 ◽

2020 ◽

Vol 2020 (1) ◽

Author(s):

E van Barneveld ◽

V B Veth ◽

J M Sampat ◽

A M F Schreurs ◽

M van Wely ◽

...

Keyword(s):

Quality Of Life ◽

Cohort Study ◽

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Pain Reduction ◽

Deep Endometriosis ◽

Ovarian Endometrioma ◽

Randomised Controlled

Abstract STUDY QUESTIONS The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical treatment of women suffering from pain due to an ovarian endometrioma when compared to treatment with medication (analgesia and/or hormones). The primary outcome is defined as successful pain reduction (−30% reduction of pain) measured by the numeric rating scale (NRS) after 6 months. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life, affective symptoms, cost-effectiveness, recurrence rate, need of adjuvant medication after surgery, ovarian reserve, adjuvant surgery and budget impact. WHAT IS KNOWN ALREADY Evidence suggests that both medication and surgical treatment of an ovarian endometrioma are effective in reducing pain and improving quality of life. However, there are no randomised studies that compare surgery to treatment with medication. STUDY DESIGN, SIZE, DURATION This study will be performed in a research network of university and teaching hospitals in the Netherlands. A multicentre randomised controlled trial and parallel prospective cohort study in patients with an ovarian endometrioma, with the exclusion of patients with deep endometriosis, will be conducted. After obtaining informed consent, eligible patients will be randomly allocated to either treatment arm (medication or surgery) by using web-based block randomisation stratified per centre. A successful pain reduction is set at a 30% decrease on the NRS at 6 months after randomisation. Based on a power of 80% and an alpha of 5% and using a continuity correction, a sample size of 69 patients in each treatment arm is needed. Accounting for a drop-out rate of 25% (i.e. loss to follow up), we need to include 92 patients in each treatment arm, i.e. 184 in total. Simultaneously, a cohort study will be performed for eligible patients who are not willing to be randomised because of a distinct preference for one of the two treatment arms. We intend to include 100 women in each treatment arm to enable standardization by inverse probability weighting, which means 200 patients in total. The expected inclusion period is 24 months with a follow-up of 18 months. PARTICIPANTS/MATERIALS, SETTING, METHODS Premenopausal women (age ≥ 18 years) with pain (dysmenorrhoea, pelvic pain or dyspareunia) and an ovarian endometrioma (cyst diameter ≥ 3 cm) who visit the outpatient clinic will make up the study population. Patients with signs of deep endometriosis will be excluded. The primary outcome is successful pain reduction, which is defined as a 30% decrease of pain on the NRS at 6 months after randomisation. Secondary outcomes include successful pain reduction after 12 and 18 months, quality of life and affective symptoms, cost-effectiveness (from a healthcare and societal perspective), number of participants needing additional surgery, need of adjuvant medication after surgery, ovarian reserve and recurrence rate of endometriomas. Measurements will be performed at baseline, 6 weeks and 6, 12 and 18 months after randomisation. STUDY FUNDING/COMPETING INTEREST(S) This study is funded by ZonMw, a Dutch organization for Health Research and Development, project number 80-85200-98-91041. The Department of Reproductive Medicine of the Amsterdam UMC location VUmc has received several research and educational grants from Guerbet, Merck KGaA and Ferring not related to the submitted work. B.W.J. Mol is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for ObsEva, Merck KGaA and Guerbet. V. Mijatovic reports grants from Guerbet, grants from Merck and grants from Ferring outside the submitted work. All authors declare that they have no competing interests concerning this publication. TRIAL REGISTRATION NUMBER Dutch Trial Register (NTR 7447, http://www.trialregister.nl). TRIAL REGISTRATION DATE 2 January 2019 DATE OF FIRST PATIENT’S ENROLMENT First inclusion in randomised controlled trial October 4, 2019. First inclusion in cohort May 22, 2019.

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