scholarly journals Effectiveness and cost-effectiveness of duloxetine added to usual care for patients with chronic pain due to hip or knee osteoarthritis: protocol of a pragmatic open-label cluster randomised trial (the DUO trial)

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e018661 ◽  
Author(s):  
Jacoline J van den Driest ◽  
Dieuwke Schiphof ◽  
Pim A J Luijsterburg ◽  
Aafke R Koffeman ◽  
Marc A Koopmanschap ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Usual Care ◽  
Open Cluster ◽  
Randomised Trial ◽  
Response To Treatment ◽  
Cluster Randomised Trial ◽  
Womac Pain ◽  
Painful Condition ◽  
Cluster Randomised ◽  
Pain Subscale

IntroductionOsteoarthritis (OA) is a highly prevalent painful condition of the musculoskeletal system. The effectiveness of current analgesic options has proven to be limited and improved analgesic treatment is needed. Several randomised placebo-controlled trials have now demonstrated the efficacy of duloxetine, an antidepressant with a centrally acting effect, in the treatment of OA pain. The aim of the current study is to investigate if duloxetine is effective and cost-effective as a third-choice analgesic added to usual care for treating chronic pain compared with usual care alone in general practice.Methods and analysisA pragmatic open, cluster randomised trial is conducted. Patients with pain due to hip or knee OA on most days of the past 3 months with insufficient benefit of non-steroidal anti-inflammatory drugs or contraindications or intolerable side effects are included. General practices are randomised to either (1) duloxetine and usual care or (2) usual care only. Primary outcome is pain at 3 months measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale. Secondary outcomes at 3 months and 1 year are pain (WOMAC, at 1 year), function (WOMAC), adverse reactions, quality of life and modification of the response to treatment by the presence of centrally sensitised pain (modified PainDETECT). At 1 year, medical and productivity costs will be assessed. Analyses will be performed following the intention-to-treat principle taking the cluster design into account.Ethics and disseminationThe study is approved by the local Medical Ethics Committee (2015–293). Results will be published in a scientific peer-reviewed journal and will be communicated at conferences.Trial registration numberDutch Trial Registry(ntr4798); Pre-results.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

2019 ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Exercise Intervention ◽  
Randomised Trial ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
First Choice ◽  
Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

2019 ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Randomised Trial ◽  
General Information ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Mixed Model Analysis ◽  
Cluster Randomised ◽  
First Choice

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will more effectively reduce (I) shoulder complaints and (II) occupational shoulder exposures than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910).

scholarly journals Long-term clinical and cost-effectiveness of collaborative care (versus usual care) for people with mental–physical multimorbidity: cluster-randomised trial

2018 ◽  
Vol 213 (2) ◽  
pp. 456-463 ◽  
Author(s):  
Elizabeth M. Camacho ◽  
Linda M. Davies ◽  
Mark Hann ◽  
Nicola Small ◽  
Peter Bower ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Usual Care ◽  
Collaborative Care ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Depression Symptoms ◽  
Long Term Conditions ◽  
Cluster Randomised ◽  
Life Years

BackgroundCollaborative care can support the treatment of depression in people with long-term conditions, but long-term benefits and costs are unknown.AimsTo explore the long-term (24-month) effectiveness and cost-effectiveness of collaborative care in people with mental-physical multimorbidity.MethodA cluster randomised trial compared collaborative care (integrated physical and mental healthcare) with usual care for depression alongside diabetes and/or coronary heart disease. Depression symptoms were measured by the symptom checklist-depression scale (SCL-D13). The economic evaluation was from the perspective of the English National Health Service.Results191 participants were allocated to collaborative care and 196 to usual care. At 24 months, the mean SCL-D13 score was 0.27 (95% CI, −0.48 to −0.06) lower in the collaborative care group alongside a gain of 0.14 (95% CI, 0.06-0.21) quality-adjusted life-years (QALYs). The cost per QALY gained was £13 069.ConclusionsIn the long term, collaborative care reduces depression and is potentially cost-effective at internationally accepted willingness-to-pay thresholds.Declaration of interestNone.

scholarly journals No added value of duloxetine for patients with chronic pain due to hip or knee osteoarthritis: a cluster randomised trial

2022 ◽  
Author(s):  
Jacoline J. Driest ◽  
Dieuwke Schiphof ◽  
Aafke R. Koffeman ◽  
Marc A. Koopmanschap ◽  
Patrick J.E. Bindels ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Knee Osteoarthritis ◽  
Randomised Trial ◽  
Added Value ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

scholarly journals Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e030110 ◽  
Author(s):  
Joanna Thorn ◽  
Mei-See Man ◽  
Katherine Chaplin ◽  
Peter Bower ◽  
Sara Brookes ◽  
...  
Keyword(s):  
Primary Care ◽  
Economic Evaluation ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Randomised Trial ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Cost

ObjectivePatients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care.DesignEconomic evaluation conducted alongside a pragmatic cluster-randomised trial.SettingGeneral practices in three centres in England and Scotland.Participants797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care.InterventionThe 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments.Primary and secondary outcome measuresThe primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost–consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses.ResultsVery small increases were found in both QALYs (adjusted mean difference 0.007 (−0.009 to 0.023)) and costs (adjusted mean difference £126 (£−739 to £991)) in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was £18 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY (55.8% at £30 000 per QALY).ConclusionsThe small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal.Trial registration numberISCRTN06180958

Analysis of self-efficacy for stroke recognition and action from a cluster randomised trial evaluating the effects of stroke education pamphlets versus a 12-minute culturally tailored stroke film among Black and Hispanic churchgoers in New York

2021 ◽  
pp. 001789692110028
Author(s):  
Daudet Ilunga Tshiswaka ◽  
Jeanne Teresi ◽  
Joseph P. Eimicke ◽  
Jian Kong ◽  
James M. Noble ◽  
...  
Keyword(s):  
New York ◽  
Usual Care ◽  
Self Efficacy ◽  
Retention Rate ◽  
Randomised Trial ◽  
Intervention Group ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Impact

Background: Because early recognition of symptoms and timely treatment of stroke can reduce mortality and the long-term effects of such events, efforts to make many people both aware of these symptoms and knowledgeable about what to do when recognising them are critical for reducing impacts from stroke. Objectives: To assess the impact of a stroke preparedness film (intervention) and stroke preparedness pamphlets (usual care) on self-efficacy for stroke recognition and action. Design: Two-arm cluster randomised trial conducted between July 2013 and August 2018. Setting: A total of 13 church sites located in economically disadvantaged urban neighbourhoods in New York. Of the 883 churchgoers approached, 503 expressed interest, 375 completed eligibility screening and 312 were randomised. Participant inclusion criteria were Black or Hispanic churchgoers, aged 34 years or older, without stroke history, but at a high risk for stroke. The intervention consisted of two 12-minute stroke films: Gospel of Stroke, in English for Black participants, and Derrame Cerebral, in Spanish for Hispanic participants. Method: Participants were pre–post-tested (at baseline, 6-month follow-up and 12-month follow-up) for self-efficacy. Descriptive analysis, a linear mixed model and t tests were used to assess the effects of a stroke preparedness film and stroke preparedness pamphlets on self-efficacy. Results: Findings are based on intention-to-treat analysis. A total of 310 participants completed the study (99% retention rate). About half (53.8%) of participants were Black and 46.2% Hispanic in the intervention group; 48.3% were Black and 51.7% were Hispanic in the usual care group. Overall, both groups evidenced higher self-efficacy (i.e. lower predicted means) over time ( p < .0001), although a significant benefit was not observed for the intervention relative to usual care. Conclusion: Both stroke preparedness films and stroke preparedness pamphlets improved self-efficacy with respect to stroke recognition and action among minority churchgoers.

scholarly journals Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Jeanette Trøstrup ◽  
Lone Ramer Mikkelsen ◽  
Poul Frost ◽  
Annett Dalbøge ◽  
Mette Terp Høybye ◽  
...  
Keyword(s):  
Usual Care ◽  
Mixed Model ◽  
Randomised Trial ◽  
General Information ◽  
Self Report ◽  
Controlled Study ◽  
Cluster Randomised Trial ◽  
Mixed Model Analysis ◽  
Cluster Randomised ◽  
First Choice

Abstract Background In Denmark, exercise therapy in combination with work modification is the first-choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will more effectively reduce (1) shoulder complaints and (2) occupational shoulder exposures than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder-exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-orientated counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6-month follow-up (hypothesis I), and the mean number of min/day with the arm elevated > 60° shortly after the end of the intervention (hypothesis II). We will use a mixed-model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration Clinicaltrials.gov, ID: NCT03159910. Registered on 18 May 2017

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